20-F - MDXH - Equibles

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 20-F

(Mark One)

☐ REGISTRATION STATEMENT PURSUANT TO SECTION12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934

☒ ANNUAL REPORT PURSUANT TO SECTION 13OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

for the fiscal year ended December 31, 2022

☐ TRANSITION REPORT PURSUANT TO SECTION13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

☐ SHELL COMPANY REPORT PURSUANT TO SECTION13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

Date of event requiring this shell company report:_________

for the transition period from _________ to_________

Commission File Number:

001- 40996

MDXHEALTH SA

(Exact name of registrant as specified in its charter)

Belgium

(Jurisdiction of incorporation or organization)

CAP Business Center

Zone Industrielle des Hauts-Sarts

4040 Herstal, Belgium

(Address of principal executive offices)

Michael McGarrity

Chief Executive Officer

MDxHealth, Inc.

15279 Alton Parkway — Suite 100

Irvine, CA 92618

United States

+1 949-812-6979

(Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person)

Securities registered or to be registered pursuant to Section 12(b)of the Act:

Title of each class	Trading Symbol	Name of each exchange on which registered

| American Depositary Shares, each representing 10 ordinary shares, no nominal value per share | MDXH | The Nasdaq Capital Market |

| Ordinary shares, no par value* | * | The Nasdaq Capital Market* | | * | Not for trading, but only in connection with the listing of the American Depositary Shares on The Nasdaq Stock Market LLC. | | --- | --- |

Securities registered or to be registered pursuantto Section 12(g) of the Act. None

Securities for which there is a reporting obligationpursuant to Section 15(d) of the Act. None

Indicate the number of outstanding shares ofeach of the issuer’s class of capital or common stock as of the close of the period covered by the annual report. Ordinary shares, no nominal value per share: 162,880,936 as of December 31, 2022.

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒

If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. Yes ☐ No ☒

Note - Checking the box above will not relieve any registrant required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 from their obligations under those Sections.

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, accelerated filer, a non-accelerated filer, or an emerging growth company. See definition of “large accelerated filer”, “accelerated filer” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer	☐	Accelerated filer	☐

| Non-accelerated filer | ☒ | Emerging Growth Company | ☒ |

If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards† provided pursuant to Section 13(a) of the Exchange Act. ☐

†	The term “new or revised financial accounting standard” refers to any update issued by the Financial Accounting Standards Board to its Accounting Standards Codification after April 5, 2012.

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☐

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:

U.S. GAAP ☐	International Financial Reporting Standards as issued by the<br><br>International Accounting Standards Board ☒	Other ☐

If “Other” has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has elected to follow: Item 17 ☐ Item 18 ☐

If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

TABLE OF CONTENTS

		Page
INTRODUCTION		ii
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS		iii
PART I		1
Item 1.	Identity of Directors, Senior Management and Advisers	1
Item 2.	Offer Statistics and Expected Timetable	1
Item 3.	Key Information	1
Item 4.	Information on the Company	30
Item 4a.	Unresolved Staff Comments	54
Item 5.	Operating and Financial Review and Prospects	54
Item 6.	Directors, Senior Management and Employees	65
Item 7.	Major Shareholders and Related Party Transactions	77
Item 8.	Financial Information	80
Item 9.	The Offer and Listing	81
Item 10.	Additional Information	82
Item 11.	Quantitative and Qualitative Disclosures about Market Risk	92
Item 12.	Description of Securities Other than Equity Securities	93
PART II		95
Item 13.	Defaults, Dividend Arrearages and Delinquencies	95
Item 14.	Material Modifications to the Rights of Security Holders and Use of Proceeds	95
Item 15.	Controls and Procedures	95
Item 16.	Reserved	95
Item 16A.	Audit Committee Financial Expert	96
Item 16B.	Code of Ethics	96
Item 16C.	Principal Accountant Fees and Services	96
Item 16D.	Exemptions from the Listing Standards for Audit Committees	96
Item 16E.	Purchases of Equity Securities by the Issuer and Affiliated Purchasers	96
Item 16F.	Change in Registrant’s Certifying Accountant	96
Item 16G.	Corporate Governance	97
Item 16H.	Mine Safety Disclosure	98
Item 16I.	Disclosure Regarding Foreign Jurisdictions That Prevent Inspections	98
PART III		99
Item 17.	Financial Statements	99
Item 18.	Financial Statements	99
Item 19.	Exhibits	99

INTRODUCTION

Unless otherwise indicated or the context otherwise requires, references in this annual report to “we,” “our,” “us,” “MDxHealth,” or the “Company” refer to MDxHealth SA and its wholly owned subsidiaries.

We were incorporated on January 10, 2003 as a company with limited liability (naamloze vennootschap/société anonyme) incorporated and operating under the laws of Belgium. We are registered with the legal entities register (Liège) under enterprise number 0479.292.440. We were publicly listed on Euronext Brussels in June 2006. In October 2010 the Company’s name was changed from OncoMethylome Sciences SA to MDxHealth SA. We have two directly held, wholly owned subsidiaries: MDxHealth, Inc., a Delaware company incorporated in April 2003, and MDxHealth B.V., a Dutch company incorporated in September 2015.

Our headquarters and principal executive offices are located at CAP Business Center, Zone Industrielle des Hauts-Sarts, Rue d’Abhooz 31, 4040 Herstal, Belgium, our telephone number is +32 4 257 70 21 and our email is info@mdxhealth.com. Our website address is www.mdxhealth.com. The information contained on, or accessible through, our website is not incorporated by reference into this annual report, and you should not consider any information contained in, or that can be accessed through, our website as part of this annual report.

Our American Depositary Shares, each representing 10 ordinary shares, began trading on the Nasdaq Capital Market on November 4, 2021. Throughout this annual report, references to ADSs mean American Depository Shares or ordinary shares represented by ADSs, as the case may be. All references in this annual report to “$” are to U.S. dollars and all references to “€” are to Euros. Solely for the convenience of the reader, certain Euro amounts herein have been translated into U.S. dollars at the official exchange rate quoted as of December 31, 2022, by the European Central Bank of €1.00 to $1.067. These translations should not be considered representations that any such amounts have been, could have been or could be converted into U.S. dollars at that or any other exchange rate as at that or any other date.

Trademarks and Service Marks

We own various trademark registrations and applications, and unregistered trademarks and service marks. “MDxHealth,” “Confirm mdx,” “Select mdx,” “Resolve mdx,” “Genomic Prostate Score,” “GPS,” “Monitor mdx,” the MDxHealth logo and other trademarks or service marks of MDxHealth SA appearing in this annual report are the property of MDxHealth SA or its subsidiaries. Solely for convenience, the trademarks, service marks and trade names referred to in this annual report are listed without the ® and ™ symbols, but such references should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto. All other trademarks, trade names and service marks appearing in this annual report are the property of their respective owners. We do not intend to use or display other companies’ trademarks and trade names to imply any relationship with, or endorsement or sponsorship of us by, any other companies.

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This annual report contains forward-looking statements. All statements other than statements of historical facts contained in this annual report, including statements regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth are forward-looking statements. Forward-looking statements give our current expectations or forecasts of future events. You can find many (but not all) of these statements by looking for words such as “approximates,” “believes,” “hopes,” “expects,” “anticipates,” “estimates,” “projects,” “intends,” “plans,” “would,” “should,” “could,” “may” or other similar expressions in this annual report. These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from our historical experience and our present expectations or projections, including, but not limited to, those identified under Item 3D. “Risk Factors” in this annual report. Actual results may differ materially from those discussed as a result of various factors, including, but not limited to:

●	our plans relating to commercializing our products and services (collectively “solutions”) and the rate and degree of market acceptance of our solutions;
●	the size of the market opportunity for our Confirm mdx and Select mdx tests and other future tests and solutions we commercialize or may develop;
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●	our ability to achieve and maintain adequate levels of coverage or reimbursement for our current and future solutions we commercialize or may seek to commercialize;
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●	our plans relating to the further development of solutions;
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●	existing regulations and regulatory developments in the United States, Europe and other jurisdictions;
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●	timing, progress and results of our research and development programs;
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●	the period over which we estimate our existing cash will be sufficient to fund our future operating expenses and capital expenditure requirements;
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●	our ability to attract and retain qualified employees and key personnel;
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●	the scope of protection we are able to establish and maintain for intellectual property rights covering our products solutions and technology;
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●	our ability to operate our business without infringing the intellectual property rights and proprietary technology of third parties;
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●<br><br> <br><br><br> <br>●	cost associated with defending intellectual property<br> infringement, product liability and other claims;<br><br> <br><br><br> <br>the possibility that the anticipated benefits<br>from our business acquisitions will not be realized in full or at all or may take longer to realize than expected;
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●	the impact on our business, financial condition and results of operations from the ongoing and global COVID-19 pandemic, or any other pandemic, epidemic or outbreak of an infectious disease in the United States or worldwide; and
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●	other risks and uncertainties, including those listed under Item 3D. “Risk Factors.”
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These statements reflect our views with respect to future events as of the date of this annual report and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. These forward-looking statements represent our estimates and assumptions only as of the date of this annual report and, except as required by law, we undertake no obligation to update or review publicly any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this annual report. We anticipate that subsequent events and developments will cause our views to change. You should read this annual report and the documents referenced in this annual report and filed as exhibits to the annual report, completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements.

iii

MARKET AND INDUSTRY DATA

Unless otherwise indicated, information contained in this annual report concerning our industry and the markets in which we operate, including our general expectations and market opportunity, is based on information from our own management estimates and research, as well as from industry and general publications, research, surveys and studies conducted by third parties. Management estimates are derived from publicly available information, our knowledge of our industry and assumptions based on such information and knowledge, which we believe to be reasonable. Where information has been sourced from third parties, this information has been accurately reproduced. As far as we are aware and are able to ascertain from information published by those third parties, no facts have been omitted which would render the reproduced information inaccurate or misleading. The industry publications and third-party studies generally state that the information that they contain has been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information. Forecasts and other forward-looking information obtained from these sources are subject to the same qualifications and uncertainties as the other forward-looking statements in this annual report. See “Special Note Regarding Forward-Looking Statements.” These forecasts and forward-looking information are subject to uncertainty and risk due to a variety of factors, including those described under “Risk Factors.” These and other factors could cause results to differ materially from those expressed in our forecasts or estimates or those of independent third parties.

PART I

ITEM 1. IDENTITY OF DIRECTORS, SENIOR MANAGEMENTAND ADVISERS

Not applicable.

ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE

Not applicable.

ITEM 3. KEY INFORMATION

A. [Reserved]

B. Capitalization and Indebtedness

Not applicable.

C. Reasons for the Offer and Use of Proceeds

Not applicable.

D. Risk Factors

Our business and our industry are subject to significant risks. You should carefully consider the risks and uncertainties described below, together with all of the other information in this annual report, including our audited consolidated financial statements and related notes. This annual report also includes forward-looking statements that involve risks and uncertainties. See “Special Note Regarding Forward-Looking Statements.” If any of the following risks are realized, our business, financial condition, operating results and prospects could be materially and adversely affected.

Summary of Risk Factors

●	We have a history of losses and expect to incur net losses in the future and may never achieve profitability.
●	We might require substantial additional funding to continue our operations and to respond to business needs or take advantage of new business opportunities, which may not be available on acceptable terms, or at all.
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●	Our commercial success will depend on the market acceptance and adoption of our current and future tests.
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●	We face uncertainties over the reimbursement of our tests by third party payors.
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●	Billing and collections processing for our tests is complex and time-consuming, and any delay in transmitting and collecting claims could have an adverse effect on revenue.
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●	Our business and reputation will suffer if we are unable to establish and comply with, stringent quality standards to assure that the highest level of quality is observed in the performance of our tests.
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●	We expect to make significant investments to research and develop new tests, which may not be successful.
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●	Failure to comply with governmental payor regulations could result in us being excluded from participation in Medicare, Medicaid or other governmental payor programs, which would adversely affect our business.
●	We conduct business in a heavily regulated industry, and changes in regulations or violations of regulations may, directly or indirectly, adversely affect our results of operations and financial condition and harm our business.
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●	If the FDA were to begin requiring approval<br>or clearance of our tests, we could incur substantial costs and time delays associated with meeting requirements for premarket clearance<br>or approval. The dual listing of our ordinary shares and ADSs following the U.S. offering may adversely affect the liquidity and value<br>of the ADSs.
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●	We may engage in acquisitions that are not<br> successful and which could disrupt our business, cause dilution to our stockholders and reduce our financial resources.
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Risks Related to Our Business and Industry

We have a history of losses and expect toincur net losses in the future and may never achieve profitability.

We have incurred substantial net losses since our inception, and there can be no assurance that we will achieve profitability. As of December 31, 2022, we had an accumulated deficit of $288.3 million and for the year ended December 31, 2022, we had a net loss of $44.0 million and net cash used in operating activities of $34.1 million. We expect our losses to continue as a result of costs relating to ongoing research and development and for increased sales and marketing costs for existing and planned solutions. These losses have had, and will continue to have, an adverse effect on our working capital, total assets, and stockholders’ equity. Even if we achieve significant revenues, we may not become profitable, and even if we achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Failure to become and remain consistently profitable could adversely affect the market price of our common stock and could significantly impair our ability to raise capital or expand our business in accordance with our growth strategy. Historically, we have been able to raise capital at regular occasions. If we are unable to continue to do this, our ability to operate as a going concern could be seriously compromised.

We may require substantial additional fundingto continue our operations and to respond to business needs (including repayment of our outstanding debt) or take advantage of new businessopportunities, which may not be available on acceptable terms, or at all.

Our capital outlays and operating expenditures are expected to increase over the next several years as commercial operations expand. We may require additional equity or debt funding from time to time in case of a shortfall in cash inflows from operations or to respond to business needs (including repayment of our outstanding debt) or take advantage of new business opportunities, which may not be available at acceptable terms, or at all. For more information about our cash and cash equivalent position or total liquidity position, see also Item 5B. “Liquidity and Capital Resources.”

Additionally, under the terms of the Asset Purchase Agreement in relation to the acquisition of the Oncotype DX GPS prostate cancer business of Exact Sciences Corporation (“Exact Sciences”), following the closing, an additional aggregate earn-out amount of up to $70 million is to be paid by us to Exact Sciences over the course of 2024, 2025 and 2026, in an amount equal to a portion of the prior calendar year’s reported revenues attributable to the Oncotype DX GPS prostate cancer business, with the maximum earn-out payable in 2024 and 2025 not to exceed $30 million and $40 million, respectively. At the our option, the earn-out amounts can be settled in cash or through the issuance of additional ADSs (valued in function of a volume weighted average trading price of our shares at the end of the relevant earn-out period) to Exact Sciences, provided that the aggregate number of shares representing the ADSs held by Exact Sciences will not exceed more than 5% of our outstanding shares.

If additional funds are raised through the sale of equity, convertible debt or other equity-linked securities, our securityholders’ ownership will be diluted. Any equity securities issued also may provide for rights, preferences or privileges senior to those of holders of ordinary shares. If additional funds are raised by issuing debt securities, these debt securities would have rights, preferences and privileges senior to those of shareholders, and the terms of the debt securities issued could impose significant restrictions on our operations.

If adequate funds are not available, we may have to scale back our operations or limit our research and development activities, which may cause us to grow at a slower pace, or not at all, and our business could be adversely affected.

Our loan facility contains restrictionsthat limit our flexibility in operating our business, and if we fail to comply with the covenants and other obligations under our loanagreement, the lenders may be able to accelerate amounts owed under the facility and may foreclose upon the assets securing our obligations.

In August 2022, we entered into a $35 million loan and security agreement with an affiliate of Innovatus Capital Partners, LLC (“Innovatus”). Under this agreement, at the option of the Company, an additional $35 million can be drawn from Innovatus, consisting of a $20 million term B loan and a $15 million term C loan, which can be drawn in 2024 and 2025 respectively, subject to certain conditions. There can be no assurance that these conditions will be satisfied and that we will be able to draw any further term loan amounts under this facility.

The loans are secured by substantially all assets of the Company, including intellectual property related to our Confirm mdx, Select mdx and Genomic Prostate Score (“GPS”) tests. The loan agreement also subjects us to certain affirmative and negative covenants, including limitations on our ability to transfer or dispose of assets, merge with or acquire other companies, make investments, pay dividends, incur additional indebtedness and liens and conduct transactions with affiliates. As a result of these covenants, we have certain limitations on the manner in which we can conduct our business, and we may be restricted from engaging in favorable business activities or financing future operations or capital needs until our current debt obligations are paid in full or we obtain the consent of Innovatus, which we may not be able to obtain. We cannot be certain that we will be able to generate sufficient cash flow or revenue to meet the financial covenants or pay the principal and accrued interest on the debt.

In addition, upon the occurrence of an event of default or a mandatory prepayment event, Innovatus, among other things, can declare all indebtedness due and payable immediately, which would adversely impact liquidity and reduce the availability of cash flows to fund working capital needs, capital expenditures and other general corporate purposes. An event of default or a mandatory prepayment event includes, but is not limited to, our failure to pay any amount due and payable under the loan agreement, the breach of any representation or warranty in the loan agreement, the breach of any covenant in the loan agreement (subject to a cure period in some cases), a change of control as defined in the loan agreement, certain defaults on loan agreements with third parties and insolvency events and proceedings. If an event of default or a mandatory prepayment event occurs and we are unable to repay amounts due under the loan agreement, Innovatus could foreclose on substantially all of our assets, including intellectual property. We cannot be certain that future working capital, borrowings or equity financings will be available to repay or refinance our debt to Innovatus or any other debt we may incur in the future.

Furthermore, we must meet certain covenants in order to draw down an additional $20 million term B loan and a $15 million term C loan that remain available under the $70 million Innovatus facility in 2024 and 2025, respectively. The availability of the $20 million term B loan and a $15 million term C loans are intended to coincide with the anticipated contingent earn-out payment obligations due under the terms of the Asset Purchase Agreement in relation to the acquisition of the Oncotype DX GPS prostate cancer business of Exact Sciences. If we do not have sufficient working capital to fund our earn-out payment obligations to Exact Sciences if and when they become due, and we are also unable to meet loan covenants necessary to draw down one or more of the additional Innovatus term loans, we may be unable to satisfy our contractual obligations to Exact Sciences, resulting in a material breach under the Asset Purchase Agreement with Exact Sciences as well as an event of default under the loan agreement with Innovatus, and our business could be adversely affected.

Our acceptance of a Paycheck ProtectionProgram loan subjects us to a variety of federal regulations and although we may apply for forgiveness of this loan it may not be forgiven.

In April 2020, we qualified for a $2.3 million loan through the Paycheck Protection Program (the “PPP”) of the U.S. Coronavirus Aid, Relief and Economic Security Act (the “CARES Act”), under a loan agreement administered by the U.S. Small Business Administration. By participating in a federal loan program, we become subject to increased governmental oversight and federal regulatory compliance obligations, including potential civil and criminal liability for making false claims or statements under the U.S. False Claims Act, 31 USC. § 3729 et seq. (the “FCA”). Liability under the FCA and similar federal statutes can carry significant potential monetary penalties and potential jail time, and can arise from both “knowing” and “willful” misstatements. FCA violations will result in a civil penalty per false claim, of not less than $11,181 and not more than $22,363, plus treble the government’s actual damages. A person who violates § 3729 will also be held liable for the government’s costs for bringing a civil action to recover any penalty or damages. If, despite our good faith belief that we satisfied all eligibility requirements for the PPP loan, we are found to have been ineligible to receive the PPP loan or in violation of any of the laws or regulations that apply to us in connection with the PPP loan, we may be subject to penalties, including under the FCA, and could be required to repay the PPP loan. Additionally, a review or audit by the U.S. Small Business Administration (“SBA”) or other government entity in connection with any future forgiveness application (if we chose to apply for forgiveness) or claims under the False Claims Act could consume significant financial and management resources. Any of these events could harm our business, results of operations and financial condition.

We may engage in acquisitions that are notsuccessful and which could disrupt our business, cause dilution to our stockholders and reduce our financial resources.

In addition to our acquisition of NovioGendix, a privately held company based in Nijmegen, The Netherlands, in September 2015 and our acquisition of our GPS test from Genomic Health, Inc., a subsidiary of Exact Sciences, in August 2022, we may enter into other transactions in the future to acquire other businesses, products or technologies. We may be unable to realize the anticipated benefits of the acquisitions or do so within the anticipated timeframe. Any acquisitions may not strengthen our competitive position, and these transactions may be viewed negatively by customers or investors. We could incur losses resulting from undiscovered liabilities of the acquired business that are not covered by the indemnification we may obtain from the seller. In addition, we may not be able to successfully integrate the acquired personnel, technologies and operations into our existing business in an effective, timely and non-disruptive manner. If we are unable to do so, the disruption to our operations could result in additional costs or could distract management’s attention from other initiatives.

The molecular diagnostics industry is highlycompetitive and characterized by rapid technological changes and we may be unable to keep pace with our competitors.

The molecular diagnostics field is characterized by rapid technological changes, frequent new product introductions, changing customer preferences, emerging competition, evolving industry and regulatory compliance standards, reimbursement uncertainty and price competition. Moreover, the molecular diagnostics field is intensely competitive both in terms of service and price, and continues to undergo significant consolidation, permitting larger clinical laboratory service providers to increase cost efficiencies and service levels, resulting in more intense competition.

The market for assessing men at risk for prostate cancer diagnosis or aggressiveness is large. As a result, this market has attracted competitors, some of which possess substantially greater financial, selling, logistical and laboratory resources, more experience in dealing with third-party payors, and greater market penetration, purchasing power and marketing budgets, as well as more experience in providing diagnostic services. Some companies and institutions are developing serum-based tests and diagnostic tests based on the detection of proteins, nucleic acids or the presence of fragments of mutated genes in the blood that are associated with prostate cancer. These competitors could have technological, financial, reputational, and market access advantages over us.

Regarding our Confirm mdx for Prostate Cancer tissue-based test, several directly competitive products are currently commercially available. In 2014, OPKO Health, Inc., a NYSE listed company, launched the 4Kscore test, a blood based 4-plex test which combines the results of the blood test with clinical information in an algorithm that calculates a patient’s percent risk for aggressive prostate cancer prior to a biopsy. OPKO is the third largest clinical laboratory in the United States, with a significantly larger sales and marketing team than we have. The 4Kscore test obtained FDA marketing approval in December 2021. Offered at a lower price point, the 4Kscore test offers a competitive price advantage over the Confirm mdx test. The PCA-3 test from Hologic, a urine-based test, is on the U.S. market as an FDA approved test, which may be perceived as providing a competitive advantage since the Confirm mdx for Prostate Cancer test is not FDA approved. The PCA-3 test is intended for the same patient population as Confirm mdx for Prostate Cancer, but our performance has only been established in men who were already recommended by urologists for repeat biopsy.

Regarding our Select mdx for Prostate Cancer tissue-based test, several directly competitive products are currently commercially available. In 2016, ExosomeDx launched the ExoDx (Intelliscore), a urine-based test designed to assess whether a patient presenting for an initial biopsy is at greater risk for high-grade prostate cancer. The ExoDx test competes directly with Select mdx. In 2018, Bio-Techne Corporation, a large U.S.-based, diversified life sciences company, acquired the ExoDx test. Bio-Techne has greater resources and a significantly larger sales and marketing team than we have. For instance, based on recent Securities and Exchange Commission (“SEC”) filings, Bio-Techne has total assets in excess of $1 billion and a market capitalization exceeding $10 billion. In addition, the ExoDx test may also provide a competitive advantage since, unlike the Select mdx test, it does not require a prostate massage as part of its specimen collection procedures. In addition to ExoDx, the 4Kscore test offered by OPKO and the Prostate Health Index test, or the “phi score”, offered by Beckman Coulter, both compete directly with the Select mdx test.

Regarding our GPS tissue-based test, acquired in August 2022 from Exact Sciences, several directly competitive products are currently commercially available. Myriad Genetics offers the Prolaris test, a tissue-based genetic test to help identify those men who need treatment versus those who can choose active surveillance. Additionally, Veracyte offers the Decipher test, a tissue-based genetic test to help identify those men who need treatment versus those who can choose active surveillance. In addition to directly competitive genomic tests, traditional methods used by pathologists and clinicians to estimate risk for disease progression also pose competitive threats. Companies combining these traditional methods with artificial intelligence could potentially emerge as competitors, though most of these technologies are currently in the research stage.

Each of OPKO, Myriad Genetics, and Beckman Coulter have greater resources and a significantly larger sales and marketing team than we do. Beckman Coulter is owned by Danaher Corporation, which had total assets in excess of $50 billion based on recent SEC filings and a market capitalization in excess of $150 billion. Myriad Genetics had total assets in excess of $1 billion based on recent SEC filings and a market capitalization in excess of $1.5 billion. As a result of these significantly greater resources, these competitors are able to make larger investments into the tests they produce and the sales and marketing of these tests, which may cause us to lose market share. In addition to competitive products, the Confirm mdx, Select mdx and GPS tests also face competition from multiparametric MRI (“mpMRI”), a clinical diagnostic imaging procedure available to and used by physicians for many years, which focuses on visual tissue analysis. The mpMRI procedure can visually reveal potential locations of abnormal and potentially cancerous prostate tissue characteristics that distinguish tumors from healthy tissue. The visual aspect of diagnostic imaging may feel more accessible and be considered preferable by some physicians over molecular analysis, and there likely is an economic incentive for some physicians to earn a professional fee from the performance of mpMRI procedures. It may be difficult to change the methods or behavior of physicians to incorporate our testing solutions into their practices in conjunction with, or instead of, mpMRI clinical diagnostic imaging procedures. In addition, companies developing or offering capital equipment or point-of-care kits to physicians represent another source of potential competition. These devices are used directly by the physicians or their institutions, which can facilitate adoption.

If we are unable to compete effectively with the abovementioned competitors and with new technologies and procedures such as mpMRI, we may lose market share, which could in turn adversely affect our revenues.

Our commercial success will depend on themarket acceptance and adoption of our current and future tests.

Healthcare providers typically take a long time to adopt new products, testing practices and clinical treatments, partly because of perceived liability risks and the uncertainty of third-party coverage and reimbursement. It is critical to the success of our sales efforts that we educate enough patients, clinicians and administrators about molecular diagnostics testing, in general, as well as about our solutions, and demonstrate their clinical benefits. It is likely that clinicians may not adopt, and third-party payors may not cover or adequately reimburse for, our tests unless they determine, based on published peer-reviewed journal articles and the experience of other clinicians, that they provide accurate, reliable and cost-effective information.

As the healthcare reimbursement system in the United States evolves to place greater emphasis on comparative effectiveness and outcomes data, we cannot predict whether we will have sufficient data, or whether the data we have will be presented to the satisfaction of any payors seeking such data, in the process of determining and maintaining coverage for our diagnostic tests. The administration of clinical and economic utility studies is expensive and demands significant attention from the management team. Our largest ongoing study, a multicenter U.S. observational study of Confirm mdx and Select mdx entitled a Prospective Validation of Prostate Biomarkers for Repeat Biopsy (“PRIORITY”), has encountered delays in enrollment and completion as a result of the COVID-19 pandemic. Additionally, we have several smaller post-marketing clinical studies ongoing or planned that are primarily intended to support expanded indications for our Confirm mdx, Select mdx and GPS tests. There can be no assurance that the PRIORITY study or our other clinical studies will be successfully initiated, enrolled or completed. Also, data collected from these studies may not be positive or consistent with our existing data or may not be statistically significant or compelling to the medical community. If the results obtained from ongoing or future studies are inconsistent with certain results obtained from previous studies, adoption of diagnostic services would suffer, and our business would be harmed.

If our tests or the technology underlying our current or future tests do not receive sufficient favorable exposure in peer-reviewed publications, the rate of clinician adoption of our tests and positive reimbursement coverage decisions for our tests could be negatively affected. See “Risk Factors —We face uncertainties over the reimbursement of our tests by third party payors.” The publication of clinical data in peer-reviewed journals is a crucial step in commercializing and obtaining reimbursement for diagnostic tests, and our inability to control when, if ever, our results are published may delay or limit our ability to derive sufficient revenue from any product that is the subject of a study.

Our financial results are largely dependenton sales of one test, and we will need to generate sufficient revenues from this and other future solutions to grow our business.

Currently, we rely significantly on the sale of Confirm mdx tests in the United States for our revenues, with these tests accounting for approximately 59%, 91% and 94% of total revenues in 2022, 2021 and 2020, respectively. We have materially diversified our revenue through the acquisition of the GPS test, with further revenue diversification attributable to the launch of an additional precision diagnostic test offering and clinical guideline inclusion for Select mdx, which facilitates reimbursement. However, sales of Confirm mdx are expected to continue to account for a substantial portion of total revenues for at least the next several years. If reimbursement for our tests were to be revoked or limited either by CMS or commercial payors, this could have an immediate impact on our revenues. While we do not believe that revocation of Medicare reimbursement for Confirm mdx or GPS tests is likely, if this were to occur, the impact could be severe.

The commercial success of solutions and our ability to generate sales will depend on several factors, including:

●	acceptance by the medical community;
●	the number of patients undergoing a prostate biopsy procedure;
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●	acceptance, endorsement and formal policy approval of favorable reimbursement for the test by Medicare and other third-party payors;
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●	our ability to successfully market the tests;
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●	the amount and nature of competition from other prostate cancer products and procedures; and
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●	our ability to establish and maintain commercial distribution, sales force and laboratory testing capabilities.
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If we are unable to increase sales and reimbursement of our current solutions or successfully develop and commercialize other solutions or enhancements, our revenues and our ability to achieve profitability would be impaired, and the market price of our shares could decline.

We face uncertainties concerning the coverageand reimbursement of our solutions by third-party payors.

Successful commercialization of our solutions depends, in large part, on the availability of coverage and adequate reimbursement from government and private payors. Favorable third-party payor coverage and reimbursement are essential to meeting our immediate objectives and long-term commercial goals. In the United States, for new diagnostic solutions, each private and government payor decides whether to cover the test, the amount it will reimburse clinical laboratories or other providers for a covered test, and any specific conditions for coverage and reimbursement. Healthcare providers may be unlikely to order a specific diagnostic test unless an applicable third-party payor offers meaningful reimbursement for the test. Therefore, adequate coverage and reimbursement is critical to the commercial success of a diagnostic product, and if we are unable to secure and maintain favorable coverage determinations and reimbursement, this will undermine our ability to earn revenue from our products.

Medicare

Reimbursement for diagnostic tests furnished to Medicare beneficiaries (typically patients aged 65 or older) is usually based on a fee schedule set by the U.S. Centers for Medicare & Medicaid Services (“CMS”), a division of the U.S. Department of Health and Human Services (“HHS”). As a Medicare-enrolled provider with our primary laboratory based in California, we bill Noridian Healthcare Solutions (“Noridian”), the Medicare Administrative Contractor (“MAC”), for California, and our Select mdx, Confirm mdx, and GPS tests are subject to Noridian’s local coverage and reimbursement policies. Noridian participates in the Molecular Diagnostic Services Program (“MolDX”), administered by Palmetto GBA, which handles technical assessments for U.S. laboratories that perform molecular diagnostic testing. The Confirm mdx test obtained a positive Medicare local coverage determination (“LCD”) under the MolDX program in 2014, the GPS test obtained a positive Medicare coverage LCD in 2015, and the Select mdx test obtained a positive Medicare coverage LCD in April 2023, each of which provides coverage for Medicare patients throughout the United States.

Medicare accounted for approximately 43% of MDxHealth’s revenues in 2022, compared to 38% in 2021. See Note 4 in the Notes to Consolidated Financial Statements included in Part III for further detail.

Commercial payors

Obtaining coverage and reimbursement by commercial payors is a time-consuming and costly process, without a guaranteed outcome, since each commercial payor makes its own decision with respect to whether to cover a particular test and, if so, at what rate to reimburse providers for that test. In addition, several payors and other entities conduct technology assessments of new medical tests and devices and provide the results of these assessments for informational purposes to other parties. These assessments may be used by third-party payors and healthcare providers as grounds to deny coverage for a particular test, or to refuse to use or order a particular test or procedure. Our tests have received initial negative technology assessments from several of these entities and are likely to receive more negative technology assessments. We continue to work with third-party payors to obtain coverage and reimbursement for our tests and to appeal coverage denial decisions based on existing and ongoing studies, peer reviewed publications, and support from physician and patient groups. There are no assurances that commercial payors will continue to issue positive coverage and reimbursement policies and/or contracts and, if issued, that such policies and/or contracts will be maintained in the future. If our tests are considered on a policy-wide level by major third-party payors, whether at our request or on the payor’s own initiative, and the payor determines that such tests are ineligible for coverage and reimbursement, our revenue potential could be adversely impacted.

Outside the United States

Outside of the United States, various coverage, pricing and reimbursement approvals are required, including through coverage determinations made at the national level under public benefit programs. We expect that it will take several years to establish broad coverage and reimbursement for our tests with payors in countries outside of the United States where we commercialize our solutions, and our efforts may not be successful. Even if public or private reimbursement is obtained, it may cover competing tests, the reimbursement may be conditioned upon local performance of the tests or other requirements we may encounter difficulties in satisfying. Reimbursement levels outside of the United States may vary considerably from the reimbursement amounts we receive in the United States. In addition, because we plan in many circumstances to rely on distributors to obtain reimbursement for our tests, to the extent the distributor does not have direct reimbursement arrangements with payors, we may not be able to retain reimbursement coverage in certain countries with a particular payor; further, if our agreement with a particular distributor is terminated or expires or a distributor fails to pay for other reasons, we could lose reimbursement coverage in that jurisdiction.

Our business is affected by macroeconomicconditions.

Various macroeconomic factors could adversely affect our business and the results of our operations and financial condition, including changes in inflation, interest rates, and foreign currency exchange rates and overall economic conditions and uncertainties, including those resulting from the current and future conditions in the global financial markets. For instance, we experienced inflationary pressures in 2022 and expect such pressures to continue in 2023. Cost inflation, including increases in raw material prices, labor rates, and transportation costs may impact our profitability. Our ability to recover these cost increases through price increases is significantly limited by the process by which we are reimbursed for our products and services by government and private payors. The volatility of the capital markets could also affect the value of our investments and our ability to liquidate our investments in order to fund our operations.

Increasing interest rates and reduced access to capital markets could also adversely affect the ability of our suppliers, distributors, licensors, collaborators, contract manufacturers and other commercial partners to remain effective business partners or to remain in business. The loss of a critical business partner, or a failure to perform by a critical business partner, could have a disruptive effect on our business and could adversely affect our results of operations.

The ongoing outbreak of COVID-19, or anyfuture pandemic, could impact our sales volumes, and our business may experience other adverse effects as a result of COVID-19 or futurepandemics.

The broad and extensive impact of the COVID-19 pandemic on virtually all aspects of our business and society exacerbated many pre-existing risks to our business by making them more likely to occur or more impactful when they do occur. Accordingly, you should consider the risks described in this risk factor in addition to, and not in lieu of, the risks described elsewhere throughout these risk factors.

The level and nature of the disruption caused by COVID-19, or any future pandemic, is unpredictable, may be cyclical and long-lasting and may vary from location to location. To the extent COVID-19 conditions improve, the duration and sustainability of any such improvements will be uncertain and continuing adverse impacts and/or the degree of improvement may vary dramatically by geography and by product. The actions we take in response to any improvements in conditions, such as our return-to-office plans, may also vary widely by geography and by business and will likely be made with incomplete information; pose the risk that such actions may prove to be premature, incorrect or insufficient and could have a material, adverse impact on our business and results of operations.

Despite our efforts, the ultimate impact of COVID-19, or any future pandemic, depends on factors beyond our knowledge or control, including the duration and severity of the outbreak, third-party actions taken to contain its spread and mitigate its public health effects, and short- and long-term changes in the behaviors of medical professionals and patients resulting from the pandemic.

The ongoing militaryaction by Russia in Ukraine could have negative impact on the global economy, which could materially adversely affect our business, operations,operating results and financial condition.

On February 24, 2022, Russian forces launched significant military action against Ukraine, and sustained conflict and disruption in the region is possible. The impact to Ukraine as well as actions taken by other countries, including new and stricter sanctions imposed by Canada, the United Kingdom, the European Union, the United States, and other countries and companies and organizations against officials, individuals, regions, and industries in Russia and Ukraine, and actions taken by Russia in response to such sanctions, and each country’s potential response to such sanctions, tensions, and military actions could adversely affect the global economy and financial markets and thus could affect our business, operations, operating results and financial condition as well as the price of our common stock and our ability to raise additional capital when needed on acceptable terms. The extent and duration of the military action, sanctions and resulting market disruptions are impossible to predict, but could be substantial. Any such disruptions caused by Russian military action or resulting sanctions may magnify the impact of other risks described in this annual report on Form 20-F.

Risks Related to Our Intellectual Property

If we are unable to retain intellectualproperty protection in relation to our solutions or if we are required to expend significant resources to protect our intellectual propertyposition, our competitive position could be undercut.

Our ability to protect our discoveries, know-how and technologies affects our ability to compete and to achieve profitability. We rely on a combination of U.S. and foreign patents and patent applications, copyrights, trademarks and trademark applications, confidentiality or non-disclosure agreements, material transfer agreements, licenses and consulting agreements to protect our intellectual property rights. We also maintain certain company know-how, algorithms, and technological innovations designed to provide us with a competitive advantage in the marketplace as trade secrets. As of December 31, 2022, we owned or had exclusive rights to more than 17 patent families related to our molecular technology and cancer-specific biomarkers. Specifically, there are 116 granted or pending patent applications in this group comprised of 16 issued or allowed U.S. patents, 7 pending U.S. provisional or non-provisional applications, 19 pending international patent applications filed under the Patent Cooperation Treaty (“PCT”) and 74 granted or allowed patents in jurisdictions outside the United States, including Japan, Canada, Israel and the major European countries. Our issued U.S. patents expire at various times between 2024 and 2038. Of these issued patents, 1 covers intellectual property used in our Confirm mdx test, which expires in 2024, 7 cover intellectual property used in our Select mdx test, the last of which expires in 2036, and 52 cover intellectual property used in our GPS test, the last of which expires in 2038. When these patents expire other companies will no longer be prohibited from incorporating the subject intellectual property into competing tests they may seek to develop.

While we intend to pursue additional and future patent applications, it is possible that pending patent applications and any future applications may not result in issued patents. Even if patents are issued, third parties may independently develop similar or competing technology that avoids our patents. Third parties may also assert infringement or other intellectual property claims against us or against our licensors, licensees, suppliers or strategic partners. Any actions regarding patents could be costly and time-consuming and could divert the attention of management and key personnel from other areas of our business. Further, we cannot be certain that the steps we have taken will prevent the misappropriation of our trade secrets and other confidential information as well as the misuse of our patents and other intellectual property, particularly in foreign countries with no patent protection.

Although we have licensed and own issued patents in the United States and foreign countries, we cannot be certain the claims will continue to be considered patentable by the U.S. Patent and Trademark Office (the “USPTO”), U.S. courts patent offices and courts in other jurisdictions. The U.S. Supreme Court, other federal courts and/or the USPTO, may change the standards of patentability and any such changes could have a negative impact on our business. For instance, the Federal Circuit has recently ruled on several patent cases, such as Univ. of Utah Research Found.v. Ambry Genetics Corp., 774 F.3d 755 (Fed. Cir. 2014), Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015), Genetic Tech. Ltd. v. Merial LLC, 818 F.3d 1369 (Fed. Cir. 2016), and Cleveland Clinic Found. v. TrueHealth Diagnostics, 859 F.3d 1352 (Fed. Cir. 2017), that some diagnostic method claims are not patent eligible. These decisions have narrowed the scope of patent protection available in certain circumstances or weakened the rights of patent owners in certain situations. Some aspects of our technology involve processes that may be subject to this evolving standard and we cannot guarantee that any of our issued or pending process claims will be patentable as a result of such evolving standards. In addition, this combination of decisions has created uncertainty as to the value of certain issued patents, in particular in the detection of prostate cancer and other cancers.

We may be subject to substantial costs andliabilities, or be prevented from using technologies incorporated in our solutions, as a result of litigation or other proceedings relatingto patent rights.

Third parties may assert infringement or other intellectual property claims against us or our licensors, licensees, suppliers or strategic partners. We pursue a patent strategy that we believe provides us with a competitive advantage in the assessment of prostate cancer and is designed to maximize patent protection against third parties in the United States and, potentially, in certain foreign countries. In order to protect or enforce our patent rights, we may have to initiate actions against third parties. Any actions regarding patents could be costly and time-consuming and could divert the attention of management and key personnel from other areas of our business. Additionally, such actions could result in challenges to the validity or applicability of our patents. Because the USPTO maintains patent applications in secrecy until a patent application is published or the patent is issued, we have no way of knowing if others may have filed patent applications covering technologies used by us or our partners. Additionally, there may be third-party patents, patent applications and other intellectual property relevant our technologies that may block or compete with our technologies. Even if third-party claims are without merit, defending a lawsuit may result in substantial expense to us and may divert the attention of management and key personnel. In addition, we cannot provide assurance that we would prevail in any such suits or that the damages or other remedies, if any, awarded against us would not be substantial. Claims of intellectual property infringement may require us, or our strategic partners, to enter into royalty or license agreements with third parties that may not be available on acceptable terms, if at all. These claims may also result in injunctions which could prevent us from further developing and commercializing services or products containing our technologies, which could in turn adversely affect our ability to earn revenues from these services or products.

Also, patents and patent applications owned by us may become the subject of post grant challenges or interference proceedings in the USPTO to determine validity and the priority of invention, which could result in substantial cost as well as a possible adverse decision as to the validity or priority of invention of the patent or patent application involved. An adverse decision in an interference proceeding may result in the loss of rights under a patent or patent application subject to such a proceeding.

Ultimately, the potential weakening of our intellectual property position as a result of the evolution of case law or otherwise may make us more vulnerable to competition. While we are unable to quantify the impact of this risk given that our patents remain untested in the courts, the impact could be severe if our competitors are able to take advantage of any weakening of our intellectual property position.

We rely on strategic collaborative and licensearrangements with third parties to develop critical intellectual property. We may not be able to successfully establish and maintain suchintellectual property.

The development and commercialization of our products and services rely, directly or indirectly, upon strategic collaborations and license agreements with third parties. We have a license agreement with an academic institution pursuant to which we have incorporated licensed technology into our Confirm mdx test and may incorporate licensed technology into our pipeline products. Our dependence on license, collaboration and other similar agreements with third parties may subject us to a number of risks. There can be no assurance that any current contractual arrangements between us and third parties or between our strategic partners and other third parties will be continued on materially similar terms and will not be breached or terminated early. Any failure to obtain or retain the rights to necessary technologies on acceptable commercial terms could require us to re-configure our products and services, which could negatively impact their commercial sale or increase the associated costs, either of which could materially harm our business and adversely affect our future revenues and ability to achieve sustained profitability.

We expect to continue and expand our reliance on collaboration and license arrangements. Establishing new strategic collaborations and license arrangements is difficult and time-consuming. Discussions with potential collaborators or licensors may not lead to the establishment of collaborations on favorable terms, if at all. To the extent we agree to work exclusively with one collaborator in a given area, our opportunities to collaborate with other entities could be limited. Potential collaborators or licensors may reject collaborations with us based upon their assessment of our financial, regulatory or intellectual property position or other factors. Even if we successfully establish new collaborations, these relationships may never result in the successful commercialization of any product or service. In addition, the success of the projects that require collaboration with third parties will be dependent on the continued success of such collaborators. There is no guarantee that our collaborators will continue to be successful and, as a result, we may expend considerable time and resources developing products or services that will not ultimately be commercialized.

Risks Related to Our Operations

Billing and collections processing for ourtests is complex and time-consuming, and any delay in transmitting and collecting for claims could adversely impact revenue.

Our tests are billed on a fee-for-service basis and paid, for example by hospitals and direct payments from individual patients, and may be reimbursed by third-party payors, including Medicare and other governmental payor programs, private insurance plans and managed care organizations. Billing for molecular diagnostics testing services is complex, time-consuming, and expensive. We are often obligated to bill services in the specific manner required by each particular third-party payor. Failure to comply with these complex billing requirements (including complex federal and state regulations related to billing government health care programs, e.g., Medicare and Medicaid) may significantly hinder our collection and retention efforts, including not only potential write-offs of doubtful accounts and long collection cycles for accounts receivable, but also the potential disgorgement of previously paid claims based on third-party payor program integrity investigations into billing discrepancies, fraud, waste and abuse. With CMS’s recent implementation of a comprehensive oversight regime that consolidated program integrity powers into a single Unified Program Integrity Contractor (“UPIC”), audit and investigatory activity into billing fraud, waste and abuse in the industry has in recent years significantly increased. Responding to requests from a UPIC, or other auditor, is often time-consuming and requires dedication of internal, and sometimes external, resources. UPICs also have the authority to implement Medicare payment suspensions during the pendency of an audit, which could significantly impact cash flows, even where no improper billing is ultimately found to have occurred. Commercial payors may also engage in audit activity, requiring timely production of medical documentation in support of billed claims.

Among the potential factors that can complicate third-party payor billing are:

●	differences between the list price for our tests and the reimbursement rates of payors;
●	compliance with complex federal and state regulations related to billing government health care programs, (e.g., Medicare and Medicaid);
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●	disputes among payors as to which party is responsible for payment;
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●	differences in coverage among payors and the effect of patient co-payments or co-insurance;
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●	differences in information and billing requirements among payors;
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●	incorrect or missing billing information; and
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●	the resources required to manage the billing and claims appeals process.
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We face an inherent risk of product liabilityclaims.

The marketing, sale and use of our tests could lead to product or professional liability claims against us if someone were to allege that our tests failed to perform as they were designed, or if someone were to misinterpret test results or improperly rely on them for clinical decisions. Although we maintain product and professional liability insurance which is deemed to be appropriate and adequate, it may not fully protect us from the financial impact of defending against product liability or professional liability claims or any judgments, fines or settlement costs arising out of any such claims. Furthermore, any product liability lawsuit, with or without merit, could increase our insurance rates or prevent us from securing insurance coverage in the future. Additionally, any product liability lawsuit could harm our reputation, which could impact our results of operations, or cause collaboration partners to terminate existing agreements and potential partners to seek alternate partners, any of which could negatively impact our results of operations.

Failure to attract or retain key personnelor to secure the support of key scientific collaborators could materially adversely impact our business.

Our success in implementing our business strategy depends largely on the skills, experience, and performance of key members of our executive management team and others in key management positions, including Michael McGarrity, our Chief Executive Officer. The collective efforts of our executive management team are critical to us as we continue to develop our technologies, tests, and R&D and sales programs. As a result of the difficulty in locating qualified new management, the loss or incapacity of existing members of our executive management team could adversely affect our operations. If we were to lose one or more of these key employees, we could experience difficulties in finding qualified successors, competing effectively, developing our technologies and implementing our business strategy. Our executives have employment agreements; however, the existence of an employment agreement does not guarantee retention of members of our executive management team. We do not maintain “key person” life insurance on any of our employees.

We have established relationships with leading key opinion leaders and scientists at important research and academic institutions that we believe are key to establishing tests using our technologies as a standard of care for cancer assessment and diagnosis. If our collaborators determine that cancer testing using our technologies are not appropriate options for prostate cancer diagnosis, or superior to available prostate cancer methods, or that alternative technologies would be more effective in the early diagnosis of prostate cancer, we would encounter significant difficulty establishing tests using our technologies as a standard of care for prostate cancer diagnosis, which would limit our revenue growth and profitability.

Our results of operations can be adverselyaffected by labor shortages, turnover and labor cost increases.

Labor is a significant component of operating our business. A number of factors may adversely affect the labor force available to us or increase labor costs, including high employment levels, federal unemployment subsidies, increased wages offered by other employers, vaccine mandates and other government regulations and our responses thereto. As more employers offer remote work, we may have more difficulty recruiting for jobs that require on-site attendance, such as certain clinical laboratory and sales roles. Although we have not experienced any material labor shortage to date, we have recently observed an overall tightening and increasingly competitive labor market. A sustained labor shortage or increased turnover rates within our employee base, caused by a pandemic or as a result of general macroeconomic factors, could lead to increased costs, such as increased overtime or financial incentives to meet demand and increased wage rates to attract and retain employees, and could negatively affect our ability to efficiently operate our clinical laboratories and overall business. If we are unable to hire and retain employees capable of performing at a high-level, or if mitigation measures we may take to respond to a decrease in labor availability have unintended negative effects, our business could be adversely affected.

Additionally, the operations of our vendors and partners could also suffer from labor shortages, turnover and labor cost increases which could result in supply change disruptions and increases in the costs of the products and services we purchase, each of which could adversely affect our operations.

Our business and reputation will sufferif we are unable to establish and comply with, stringent quality standards to assure that the highest level of quality is observed inthe performance of our solutions.

Inherent risks are involved in providing and marketing cancer tests and related services. Patients and healthcare providers rely on us to provide accurate clinical and diagnostic information that may be used to make critical healthcare decisions. As such, users of our solutions may have a greater sensitivity to errors than users of some other types of products and services.

Past or future performance or accuracy defects, incomplete or improper quality and process controls, excessively slow turnaround times, unanticipated uses of our tests or mishandling of samples or test results (whether by us, patients, healthcare providers, courier delivery services or others) can lead to adverse outcomes for patients and interruptions to our services. These events could lead to voluntary or legally mandated safety alerts relating to our tests or our laboratory facilities and could result in the removal of our products and services from the market or the suspension of our laboratories’ operations. Insufficient quality controls and any resulting negative outcomes could result in significant costs and litigation, as well as negative publicity that could reduce demand for our tests and payors’ willingness to cover our tests. Even if we maintain adequate controls and procedures, damaging and costly errors may occur.

Our laboratory facilities may become inoperabledue to natural or man-made disasters or regulatory sanctions.

We currently perform testing services in our laboratory facilities located in Irvine, California; Plano, Texas; and Nijmegen, The Netherlands and our GPS test is currently performed by Exact Sciences in its laboratory facility in Redwood City, California. These laboratory facilities could become inoperable due to circumstances that may be beyond our control, and such inoperability could adversely affect our business and operations. The facilities, equipment and other business process systems would be costly to replace and could require substantial time to repair or replace.

The facilities may be damaged or destroyed by natural or man-made disasters, including earthquakes, wildfires, floods, outbreak of disease (such as the COVID-19 pandemic), acts of terrorism or other criminal activities and power outages, which may render it difficult or impossible for us to perform our tests for some period.

The facilities may also be rendered inoperable because of regulatory sanction. In the United States, we are subject to federal and state laws and regulations regarding the operation of clinical laboratories. Our U.S. laboratory facilities in Irvine, California and Plano, Texas are certified under CLIA. CLIA and the laws of California and certain other states, impose certification requirements for clinical laboratories, and establish standards for quality assurance and quality control, among other things. Clinical laboratories are subject to inspection by regulators, and to sanctions for failing to comply with applicable requirements. Sanctions available under CLIA include prohibiting a laboratory from running tests, requiring a laboratory to implement a corrective action plan, and imposing civil monetary penalties. Our U.S. laboratory facilities hold certificates of accreditation from CMS to perform high-complexity testing. To renew these certificates, the facilities are subject to survey and inspection every two years. We also hold a certificate of accreditation from the College of American Pathologists (“CAP”), which sets standards that are higher than those contained in the CLIA regulations. CAP is an independent, non-governmental organization of board-certified pathologists that accredits laboratories nationwide on a voluntary basis. Sanctions for failure to comply with CAP or CLIA requirements, including proficiency testing violations, may include suspension, revocation, or limitation of a laboratory’s CLIA certificate, which is necessary to conduct business, as well as the imposition of significant fines or criminal penalties. In addition, our U.S. facilities are subject to regulation under state laws and regulations governing laboratory licensure. Two states, one of which is New York, have enacted state licensure laws that are more stringent than CLIA. Failure to maintain CLIA certification, CAP accreditation, or required state licenses could have a material adverse effect on the sales of our tests and results of operations. Many states maintain independent licensure, registration, or certification procedures with which our U.S. facilities must maintain compliance in order to receive and test samples from that location.

In order to rely on a third party to perform certain of our tests, we could only use another facility with established state licensure and CLIA accreditation following validation and other required procedures. We cannot assure you that we would be able to find another CLIA certified facility willing to comply with the required procedures, that this laboratory would be willing to perform the tests for us on commercially reasonable terms, or that it would be able to meet our quality or regulatory standards.

Maintaining compliance with the myriad of governmental requirements is time and resource intensive, and failure to maintain compliance could result in sanctions.

We rely on a limited number of third-partysuppliers for services and items used in the production and operation of our testing solutions, and some of those services and items aresupplied from a single source. Disruption of the supply chain, unavailability of third-party services required for the performance ofthe tests, modifications of certain items or failure to achieve economies of scale could have a material adverse effect on us.

To provide our testing services, we are required to obtain customized components and services that are currently available from a limited number of sources. Most of these components and services are sourced externally from approximately 40 external suppliers. Many of the consumable supplies and reagents used as raw materials in our testing process are procured from a limited number of suppliers, some of which are single source. In addition, we rely on a limited number of suppliers, or in some cases a single supplier (for example, for the automation of our deparaffination steps for our Confirm mdx test), for certain services and equipment with which we provide testing services. If we have to switch to a replacement supplier for any of these items that are sub-components or for certain services required for the performance of our tests, or if we have to commence our own manufacturing or testing services to satisfy market demand, we may face additional delays. For example, in the past, a supplier has delivered critical non-conforming components that failed our acceptance testing, requiring us to audit the supplier and assist the supplier in improving our internal quality processes. In addition, third party suppliers may be subject to circumstances which impact their ability to supply, including enforcement action by regulatory authorities, natural disasters (e.g., hurricanes, earthquakes, disease and terrorism), epidemics (e.g., the COVID-19 pandemic), industrial action (e.g., strikes), financial difficulties including insolvency, among a variety of other internal or external factors. Any such supply disruptions could in turn result in service disruptions for an extended period of time, which could delay completion of our clinical studies or commercialization activities and prevent us from achieving or maintaining profitability. While we were able to qualify alternative suppliers to address COVID-19 related disruptions, in the future alternative suppliers may be unavailable, may be unwilling to supply, may not have the necessary regulatory approvals, or may not have in place an adequate quality management systems.

Exact Sciences currently performs our GPS test pursuant to a reference laboratory services agreement we entered into with Exact Sciences in connection with our acquisition of the GPS test. Until we are able to transition performance of the GPS test to our laboratory facilities we will be reliant on this contractual relationship to generate revenues from this test.

Modifications to a service or items or inclusions of certain services or items made by a third-party supplier could require new approvals from the relevant regulatory authorities before the modified service or item may be used, for example any modifications to the assembly and packaging of items for our testing services supplied to healthcare providers. While we have not experienced any material supply chain disruptions to date, if we were to experience such disruptions it could have an immediate impact on revenues, and the impact could be material depending on the length of the supply disruption.

Failures in our information technology,telecommunications or other systems could significantly disrupt our operations.

We use information technology and telecommunications systems across virtually all aspects of our business, including laboratory testing, sales, billing, customer service, logistics and management of data, including patient information. Our information technology, telecommunications and other systems, are vulnerable to damage and failure, computer viruses, acts of God and physical or electronic break-ins. Despite the precautionary measures we have taken to prevent breakdowns in our information technology and telecommunications systems, sustained or repeated system failures that interrupt our ability to process test orders, deliver test results or perform tests in a timely manner or that cause us to lose patient information could adversely affect our business, results of operations and financial condition.

Although we maintain cyber liability insurance which we believe to be appropriate and adequate, the levels and terms of coverage may not be adequate to compensate us for losses that may arise from any such disruption, failure or security breach. In addition, such insurance may not be available to us in the future on economically reasonable terms, or at all. Further, insurance may not cover all claims made against us and could have high deductibles in any event, and defending a suit, regardless of its merit, could be costly and divert management attention.

Security breaches or loss of data may harmour reputation, expose us to liability and adversely affect our business.

If we experience any security breaches or loss of data or if we fail to comply with data protection laws and regulations, we could be subject to government enforcement actions (which could include civil or criminal penalties), private litigation and/or adverse publicity, which could negatively affect our results of operations and business.

We face four primary risks relative to protecting sensitive and critical personally identifiable information, intellectual property or other proprietary business information about our customers, payors, recipients and collaboration partners, including test results: (1) loss of access risk, (2) inappropriate disclosure or access risk, (3) inappropriate modification risk, and (4) the risk of being unable to identify and audit controls over the first three risks. While we devote significant resources to protecting such information, the measures we introduce may not be sufficient to guard against security breaches, the loss or misappropriation of data, privacy violations or the failure to implement satisfactory remedial measures, which could in turn disrupt operations and lead to reputational damage, regulatory penalties and other material financial losses.

Furthermore, we are subject to privacy and data security laws and regulations at the state, federal and international level. In the United States, numerous federal and state laws and regulations, including state data breach notification laws, state health information privacy laws, and federal and state consumer protection laws (e.g., section 5 of the Federal Trade Commission Act), govern the collection, use, disclosure, and protection of health-related and other personal information. Failure to comply with data protection laws and regulations could result in (1) government enforcement actions and potential liability thereunder (potentially including civil and/or criminal penalties), (2) private litigation, and/or (3) adverse publicity that could negatively affect our operations and/or business. In addition, we obtain health information from third parties (e.g., healthcare providers) and are subject to privacy and security requirements under the Health Insurance Portability and Accountability Act (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”). These laws contain significant fines and other penalties for wrongful use or disclosure of protected data. For example, HIPAA violations can result in civil and criminal penalties.

We expect to make significant investmentsto research and develop new tests, which may not be successful.

We are seeking to improve the performance of our existing solutions and to develop a pipeline for future products and services. For example, in August 2022, we announced our acquisition of the GPS test from Exact Sciences. In addition, we are currently developing an additional product, Monitor mdx, as a non-invasive test to risk stratifies patients for continued active surveillance versus intervention. We also recently developed and launched non-invasive urine test that identifies and quantifies infectious bacteria and their antibiotics susceptibility to help ensure patients receive the correct diagnosis and treatment as quickly as possible.

Developing new or improved diagnostic tests is a speculative and risky endeavor. Candidate products and services that may initially show promise may fail to achieve the desired results in larger clinical validation studies or may not achieve acceptable levels of clinical accuracy. Results from early studies or trials are not necessarily predictive of future clinical validation or clinical trial results, and interim results of a validation study or trial are not necessarily indicative of final results. From time to time, we may publicly disclose then-available data from clinical validation studies before completion, and the results and related findings and conclusions may be subject to change following the final analysis of the data related to the particular study. As a result, such data should be viewed with caution until the final data are available. Additionally, such data from clinical trials are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment and/or follow-up continues, and more patient data become available. Significant differences between initial or interim data and final data from either our clinical validation studies or clinical trials could significantly alter our plans to proceed with additional studies or trials, and harm our reputation and business prospects. If we determine that any of our current or future development programs is unlikely to succeed, we may abandon it without any return on our investment into the program. We may need to raise additional capital to bring any new products or services to market, which may not be available on acceptable terms, if at all.

Our research and development efforts willbe hindered if we are not able to obtain samples, contract with third parties for access to samples or complete timely enrollment in futureclinical trials.

Access to human sample types, such as blood, tissue, stool, or urine is necessary for our research and product development. Acquiring samples from individuals with clinical diagnoses or associated clinical outcomes through purchase or clinical studies is necessary. Lack of available samples can delay development timelines and increase costs of development. Generally, the agreements under which we gain access to human samples are non-exclusive. Other companies may compete with us for access. Additionally, the process of negotiating access to samples can be lengthy and it may involve numerous parties and approval levels to resolve complex issues such as usage rights, institutional review board approval and patient informed consent, privacy rights, publication rights, intellectual property ownership and research parameters. If we are not able to negotiate access to clinical samples with research institutions, hospitals, clinical partners, pharmaceutical companies, or companies developing therapeutics on a timely basis, or at all, or if other laboratories or our competitors secure access to these samples before us, our ability to research, develop and commercialize future products will be limited or delayed. Finally, we may not be able to conduct or complete clinical trials on a timely basis if we are not able to enroll sufficient numbers of patients in such trials, and our failure to do so could have an adverse effect on our research and development and product commercialization efforts.

Risks Related to Regulation of Our Business

Failure to comply with governmental payorregulations could result in us being excluded from participation in Medicare, Medicaid or other governmental payor programs, which wouldadversely affect our business.

Failure to comply with applicable Medicare, Medicaid and other governmental payor rules could result in us being excluded from participation in one or more governmental payor programs, returning funds already paid, civil monetary penalties, criminal penalties and/or limitations on the operational function of our laboratories. Additionally, with the recent implementation by CMS of a comprehensive oversight regime that consolidates program integrity powers into a single UPIC, audit and investigatory activity into potential billing fraud, waste and abuse in the industry has increased. These changes have adversely affected and may in the future adversely affect coverage and reimbursement for laboratory services, including the molecular diagnostics testing services we provide. If we were unable to receive reimbursement under a governmental payor program, this would have a severe impact on our revenues, given the importance of reimbursement under these programs in our revenue base.

We conduct business in a heavily regulatedindustry, and changes in, or violations of, applicable regulations may, directly or indirectly, adversely affect our operational resultsand financial condition, which could harm our business.

Our business operations and activities may be subject to a range of local, state, federal, and international healthcare laws and regulations, including investigatory and program integrity audits and other oversight federal and state health care programs. These laws and regulations currently include, among others:

●	CLIA (which requires laboratories to obtain certification from the federal government) and state laboratory licensure laws;
●	Federal Trade Commission standards regarding advertising and business practices;
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●	FDA laws and regulations;
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●	HIPAA (which imposes comprehensive federal standards with respect to the privacy and security of protected health information, and requirements for the use of certain standardized electronic transactions), and the amendments to HIPAA under HITECH (which strengthened and expanded HIPAA privacy and security compliance requirements, increased penalties for violators, extended enforcement authority to state attorneys general and imposed requirements for breach notification);
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●	state laws regulating genetic testing and the privacy protection of genetic test results, as well as state laws protecting the privacy and security of health information and personal data and mandating reporting of breaches to affected individuals and state regulators;
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●	the federal Anti-Kickback Statute (which prohibits knowingly and willfully offering, paying, soliciting, receiving, or providing remuneration, directly or indirectly, to induce either the referral of an individual, or the furnishing, arranging for, or recommending of an item or service that is reimbursable, in whole or in part, by a federal health care program) and parallel state anti-kickback laws (which contain similar prohibitions on remuneration between referral sources, although these state laws are not always limited in application to items or services reimbursable by federal or state health care programs);
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●	the federal False Claims Act (which imposes liability on any person or entity that, among other things, knowingly presents, or causes to be presented, a false or fraudulent claim for payment to the federal government or the improper retention of identified overpayments or other financial obligations to the federal government) and parallel state false claims acts (which contain similar prohibition on presenting false or fraudulent claims, although these state may extend to items or services by any third-party payor, including commercial insurers);
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●	the federal Civil Monetary Penalties Law, which prohibits, among other things, the offering or transferring of remuneration to a Medicare or state health care program (e.g., Medicaid) beneficiary if the person knows or should know it is likely to influence the beneficiary’s selection of a particular provider, practitioner, or supplier of services reimbursable by Medicare or a state health care program, unless an exception applies;
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●	the federal physician self-referral law, commonly known as the “Stark Law,” which prohibits a physician from making a referral to an entity for certain “designated health services” (“DHS”) payable by Medicare if the physician, or an immediate family member of the physician, has a financial relationship with that entity, unless an exception applies. The Stark Law further prohibits the entity from billing the Medicare program for DHS furnished pursuant to a prohibited referral. In addition, the Stark Law, through the addition of section 1903(s) to the Social Security Act, prohibits the federal government from making federal financial participation payments to state Medicaid programs for DHS furnished as a result of a referral that would violate the Stark Law if Medicare “covered the service to the same extent and under the same conditions” as the state Medicaid Program. The U.S. Department of Justice (“DOJ”) and several state agencies have successfully argued that Section 1903(s) expands the Stark Law to Medicaid-covered claims, even absent a separate state self-referral law prohibiting the same conduct;
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●	other federal and state fraud and abuse laws, including (i) the state anti-kickback laws described above, (ii) the state physician self-referral laws, and (iii) the state false claims acts described above;
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●	Section 216 of the Protecting Access to Medicare Act of 2014, which requires applicable laboratories to report commercial payor data in a timely and accurate manner beginning in 2017 and every three years thereafter (and in some cases annually);
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●	Federal and state laws that impose reporting and other compliance-related requirements; and
●	similar foreign laws and regulations that apply to us in the countries in which we operate.
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In addition, in October 2018, the Eliminating Kickbacks in Recovery Act of 2018 (“EKRA”), was enacted by the U.S. Congress as part of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act. EKRA is an all-payor anti-kickback law that makes it a criminal offense to pay any remuneration to induce referrals to, or in exchange for, patients using the services of a recovery home, a substance use clinical treatment facility, or laboratory. Although it appears that EKRA was intended to reach patient brokering and similar arrangements to induce patronage of substance use recovery and treatment, the language in EKRA is broadly written. Further, certain of EKRA’s exceptions, such as the exception applicable to relationships with employees that effectively prohibits incentive compensation, are inconsistent with the federal anti-kickback statute and regulations, which permit payment of employee incentive compensation, a practice that is common in the industry. Significantly, EKRA permits the U.S. Department of Justice to issue regulations clarifying EKRA’s exceptions or adding additional exceptions, but such regulations have not yet been issued. Laboratory industry stakeholders are reportedly seeking clarification regarding EKRA’s scope and/or amendments to its language.

Our business practices, in operating a U.S. clinical laboratory, may face heightened scrutiny from U.S. government enforcement agencies such as the DOJ, the HHS Office of Inspector General (“OIG”), and CMS. The OIG has issued fraud alerts in recent years that identify certain arrangements between clinical laboratories and referring physicians as implicating the federal Anti-Kickback Statute. The OIG has stated that it is particularly concerned about these types of arrangements because the choice of laboratory, as well as the decision to order laboratory tests, typically are made or strongly influenced by the physician, with little or no input from the patient. Moreover, the provision of payments or other items of value by a clinical laboratory to a referring physician could be prohibited under the Stark Law, unless the arrangement meets all criteria of an applicable exception. The government has actively enforced these laws against clinical laboratories in recent years.

These U.S. laws and regulations are complex and are subject to interpretation by the U.S. courts and government agencies. Our failure to comply with such laws and regulations could lead to significant civil or criminal penalties, exclusion from participation in state and federal health care programs, individual imprisonment, disgorgement of profits, contractual damages, reputational harm, diminished profits and future earnings, additional reporting or oversight obligations if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with the law, curtailment or restructuring of our operations, or prohibitions or restrictions on our laboratories’ ability to provide or receive payment for our services, any of which could adversely affect our ability to operate our business and pursue our strategy. Even where we are able to successfully defend against any such claims, any potential audit, enforcement action, or litigation would involve substantial internal and external resources, detract from our executives’ day to day responsibilities, and result in legal expenditures, all of which could materially adversely affect our results of operations. While we believe that we are in material compliance with all applicable laws and regulations, there remains a risk that one or more government agencies could take a contrary position, or that a private party could file suit under the qui tam provisions of the federal False Claims Act or a similar state law. Such occurrences, regardless of their outcome, could damage our reputation and adversely affect important business relationships with third parties, including managed care organizations, and other private third-party payors.

Our employees, independent contractors,consultants, commercial partners, and vendors may engage in misconduct or other improper activities, including noncompliance with regulatorystandards and requirements.

We are exposed to the risk of fraud, misconduct, or other illegal activity by our employees, independent contractors, consultants, commercial partners, and vendors. Misconduct by these parties could include intentional, reckless and negligent conduct that fails to: comply with the rules and regulations of the CMS, FDA, and other federal and state government agencies as well as comparable foreign regulatory authorities; provide true, complete and accurate information to such regulatory authorities; comply with manufacturing and clinical laboratory standards; comply with healthcare fraud and abuse laws in the United States and similar foreign fraudulent misconduct laws; or report financial information or data accurately or to disclose unauthorized activities to us. In particular, research, sales, marketing, education, and other business arrangements in the healthcare industry are subject to extensive laws designed to prevent fraud, kickbacks, self-dealing, and other abusive practices, as well as off-label product promotion. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, educating, marketing and promotion, sales and commission, certain customer incentive programs, and other business arrangements generally. Activities subject to these laws also involve the improper use of information obtained in the course of participant recruitment for clinical studies, which could result in regulatory sanctions and cause serious harm to our reputation. We have adopted a code of business conduct and ethics and provide compliance training to our workforce members upon onboarding and annually thereafter, but it is not always possible to identify and deter misconduct by employees and third parties, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of significant fines or other sanctions. Even if it is later determined after an action is instituted against us that we were not in violation of these laws, we may be faced with negative publicity, incur significant expenses defending our actions, and have to divert significant management resources from other matters.

Our expansion of our business beyond theUnited States has resulted in additional regulatory requirements with which we must comply.

Our expansion of our business outside of the United States increases the potential of violating foreign laws similar to those described above under “ — We conductbusiness in a heavily regulated industry, and changes in regulations or violations of regulations may, directly or indirectly, adverselyaffect our results of operations and financial condition and harm our business.” In order to market our tests in other countries, we may be required to obtain regulatory approvals and comply with extensive safety and quality regulations in other countries. The time required to obtain approval by a foreign country may be longer or shorter than that required for FDA clearance or approval, and the requirements may differ. The European Union/European Economic Area requires a CE conformity mark in order to market medical devices. Many other countries accept CE or FDA clearance or approval, although others, require separate regulatory filings. Further, the advertising and promotion of our products in the EEA is subject to the laws of individual EEA Member States implementing the EU Medical Devices Directives including Directive 98/79/EC on Invitro Diagnostic Medical Devices, Directive 2006/114/EC concerning misleading and comparative advertising, and Directive 2005/29/EC on unfair commercial practices, as well as other EEA Member State laws governing the advertising and promotion of medical devices. Going forward, CE marking will be pursuant to Regulation 2017/745 (the “Medical Devices Regulation”) and Regulation 2017/746 (the “Invitro Diagnostic Medical Devices Regulation”), which were passed by the European Parliament on April 5, 2017. The Medical Devices Regulation and the Invitro Diagnostic Medical Devices Regulation contain further obligations for medical devices and invitro diagnostic medical devices with which we will be required to comply as applicable. These new laws are generally stricter than the requirements previously in place and contain increased evidence requirements for CE marking. They may limit or restrict the advertising and promotion of our tests to the general public and may impose limitations on promotional activities with healthcare professionals. The risk of being found in violation of these or other laws and regulations is further increased by the fact that many have not been fully interpreted by the regulatory authorities or the courts, and their provisions are open to a variety of interpretations. Any action brought against us for violation of these or other laws or regulations, even in case of successful defense against it, could result in significant legal expenses and divert management’s attention from the operation of our business. While our business is primarily based in the United States, these laws or regulations would not have an immediate material impact on our revenues. However, in the longer term, our prospects could be seriously harmed.

If the FDA were to take the position thatour tests are not within the scope of its policy on enforcement discretion for laboratory-developed tests (“LDTs”), or Congressor FDA were otherwise to begin requiring approval or clearance of our tests, responding to such a development could lead to a halt inthe commercial provision of our tests until we meet the requirements for premarket approval or clearance, enforcement action from FDA,and we could incur substantial costs and time delays associated with meeting FDA requirements for premarket clearance or approval.

Although we believe we are within the scope of the FDA’s policy on enforcement discretion for LDTs, commercial availability of LDTs is subject to uncertainty given the FDA’s latitude in interpreting and applying its laws and policies. For example, although the FDA has historically exercised enforcement discretion over most LDTs, it does not consider tests to be subject to this enforcement discretion if they were or are designed or manufactured completely, or partly, outside of the laboratory that offers and uses them, or if they are offered “over-the-counter” (as opposed to being available to patients only when prescribed by a health care provider). Even for tests that appear to fall within FDA’s previously stated policy on enforcement discretion, the FDA may decide to regulate certain LDTs on a case-by-case basis at any time.

Furthermore, the laws and regulations governing the marketing of diagnostic products are evolving, extremely complex and in many instances, there are no significant regulatory or judicial interpretations of these laws and regulations. Pursuant to its authority under the federal Food, Drug, and Cosmetic Act (the “FDCA”), the FDA has jurisdiction over medical devices, including in vitro diagnostics and, therefore, potentially our clinical laboratory tests. Among other things, pursuant to the FDCA and its implementing regulations, the FDA regulates the research, testing, manufacturing, safety, labeling, storage, recordkeeping, premarket clearance or approval, marketing and promotion, and sales and distribution of medical devices in the United States to ensure that medical products distributed domestically are safe and effective for their intended uses. Although the FDA has asserted that it has authority to regulate the development and use of LDTs, such as our and many other laboratories’ tests, as medical devices, it has generally exercised enforcement discretion and is not otherwise regulating most tests developed and performed within a single high complexity CLIA-certified laboratory.

Even though our tests are commercialized in the United States as LDTs, they may in the future become subject to more onerous regulation by the FDA. For example, the FDA may disagree with the assessment that the tests fall within the definition of an LDT and seek to regulate them as medical devices. The FDA has, for over the past decade, been introducing proposals to end enforcement discretion and to bring LDTs clearly under existing FDA regulatory frameworks and the U.S. Congress has recently been working on legislation to create an LDT and in vitro diagnostic regulatory framework that would be separate and distinct from the existing medical device regulatory framework. If the FDA begins to enforce its medical device requirements for LDTs, or if the FDA disagrees with our assessment that our tests are LDTs, our company and these tests could for the first time be subject to a variety of regulatory requirements, including registration and listing, medical device reporting, and adherence to good manufacturing practices under the quality system regulations, and we could be required to obtain premarket clearance or approval for these existing tests and any new tests we may develop, which may force us to cease or delay marketing our tests until the required clearance or approval are obtained. The premarket review process for diagnostic products can be lengthy, expensive, time-consuming, and unpredictable. Further, obtaining premarket clearance or approval may involve, among other things, successfully completing clinical trials. Clinical trials require significant time and cash resources and are subject to a high degree of risk, including risks of experiencing delays, failing to complete the trial or obtaining unexpected or negative results. If we are required to obtain premarket clearance or approval and/or conduct premarket clinical trials, development costs could significantly increase, the introduction of any new tests under development may be delayed, and sales of our tests could be interrupted or stopped. Any of these outcomes could reduce revenues or increase costs and materially adversely affect our business, prospects, results of operations, or financial condition. Moreover, any cleared or approved labeling claims may not be consistent with current claims or be adequate to support continued adoption of and reimbursement for our tests. For instance, if FDA requires our tests to be labeled as investigational, or if the labeling claims the FDA allows are limited, order levels may decline and reimbursement may be adversely affected. If after commercialization under the LDT framework our tests are allowed to remain on the market but there is uncertainty about the regulatory status of our tests, including questions that may be raised if competitors object to our regulatory positioning as an LDT, we may encounter ongoing regulatory and legal challenges and related costs. Such challenges or related developments (for example if the labeling claims the FDA allows us to make are more limited than the claims we currently plan to make) may impact our commercialization efforts as orders or reimbursement may be less than anticipated. As a result, we could experience significantly increased development costs and a delay in generating additional revenue. Until the FDA finalizes its regulatory position regarding LDTs, or federal legislation is passed concerning regulation of LDTs, it is unknown how the FDA may regulate our tests in the future and what testing and data may be required to support any required clearance or approval.

The requirement of premarket review could negatively affect our business until such review is completed and regulatory clearance or approval is obtained. The FDA could require that sales of our tests be halted pending premarket clearance or approval. In December 2018 the FDA Commissioner and the Director of the Center for Devices and Radiological Health expressed significant concerns regarding disparities between some LDTs and in vitro diagnostics that have been reviewed and cleared or approved by FDA. If the FDA were to determine that our tests are not within the policy for LDTs for any reason, including new rules, policies, or guidance, or due to changes in statute, our tests may become subject to FDA requirements, including premarket review. If required, the regulatory marketing authorization process may involve, among other things, successfully completing additional clinical trials and submitting a premarket clearance (510(k)) submission or filing a de novo or premarket approval application with the FDA. If premarket review and authorization is required by the FDA, we may need to incur additional expenses or require additional time to seek it, or we may be unable to satisfy FDA standards, and our tests may not be cleared or approved on a timely basis, if at all, and the labeling claims permitted by the FDA may not be consistent with our currently planned claims or adequate to support adoption of and reimbursement for our tests. If the FDA requires any form of premarket review, our tests may not be cleared or approved on a timely basis, if at all. We may also decide voluntarily to pursue FDA premarket review and authorization of our tests if it appears that doing so would be appropriate.

In addition, we believe that the sample collection kits provided by us for collection and transport of specimens from a health care provider to our clinical laboratories are considered a Class I medical devices subject to the FDA’s general device controls but exempt from premarket review. However, the FDA could assert the specimen collection kits are non-exempt or Class II devices, which would subject them to premarket clearance or approval processes, which could be time-consuming and expensive.

Failure to comply with any applicable FDA requirements could trigger a range of enforcement actions by the FDA, including warning letters, civil monetary penalties, injunctions, criminal prosecution, recall or seizure, operating restrictions, partial suspension or total shutdown of operations and denial of or challenges to applications for clearance or approval, as well as significant adverse publicity.

Our operating results could be materiallyadversely affected by unanticipated changes in tax laws and regulations, adjustments to our tax provisions, exposure to additional taxliabilities, or forfeiture of our tax assets.

We are subject to laws and regulations on tax levies and other charges or contributions in different countries, including transfer pricing and tax regulations for the compensation of personnel and third parties. Our tax structure involves several transfers and transfer price determinations between our parent company and our subsidiaries or other affiliates. Our effective tax rates could be adversely affected by changes in tax laws, treaties and regulations, both internationally and domestically. An increase of the effective tax rates could have an adverse effect on our business, financial position, results of operations and cash flows.

The net operating loss carry forwards of our corporate subsidiaries may be unavailable to offset future taxable income because of restrictions under U.S. tax law. As of December 31, 2022, consolidated net tax loss carry forwards amounted to $285.3 million. Our NOLs generated in tax years ending on or prior to December 31, 2017 are only permitted to be carried forward for 20 taxable years under applicable U.S. federal tax law, and therefore could expire unused. We consider that it is highly likely that we will be unable to use at least a portion of these NOLs, in light of our continued losses. Under tax legislation commonly referred to as the Tax Cuts and Jobs Act (“TCJA”), as modified by the CARES Act, our federal NOLs generated in tax years ending after December 31, 2017 may be carried forward indefinitely and NOLs arising in taxable years beginning after December 31, 2017 and before January 1, 2021 may be carried back to each of the five taxable years preceding the tax year of such loss, but NOLs arising in taxable years beginning after December 31, 2020 may not be carried back. In addition, under the TCJA, as modified by the CARES Act, for taxable years beginning after December 31, 2020, the deductibility of federal NOLs generated in taxable years beginning after December 31, 2017 is limited to 80% of current year taxable income. It is uncertain if and to what extent various states will conform to the TCJA, as modified by the CARES Act.

In addition, under sections 382 and 383 of the Internal Revenue Code of 1986, as amended, or the Code, if a corporation undergoes an “ownership change” (generally defined as a cumulative change in ownership by “5-percent shareholders” that exceeds 50 percentage points over a rolling three-year period), the corporation’s ability to use its pre-change NOLs and certain other pre-change tax attributes to offset post-change income and taxes may be limited. Similar rules may apply under state tax laws. Our existing NOLs and other certain tax attributes may be subject to limitations arising from previous ownership changes. In addition, future changes in our stock ownership, many of which are outside of our control, could result in an ownership change under Sections 382 and 383 of the Code. We have not conducted any studies to determine annual limitations, if any, that could result from such changes in the ownership. Our ability to utilize those NOLs and certain other tax attributes could be limited by an “ownership change” as described above and consequently, we may not be able to utilize a material portion of our NOLs and certain other tax attributes, which could have a material adverse effect on our cash flows and results of operations by effectively increasing our future tax obligations.

Also under Belgian tax law, certain restrictions regarding the use of Belgian tax losses carried forward apply and these losses may also be forfeited upon certain changes of control over Belgian corporate taxpayers. As a COVID-19 measure, some limited tax loss carried back mechanism was introduced in Belgian tax law.

Given that we have historically generated operating losses, any change in our ability to use NOLs could have a severe impact on us if and when we become profitable. As of December 31, 2022, we had an accumulated deficit of $288.3 million and for the year ended December 31, 2022, we had a net loss of $44.0 million.

Risks Related to Ownership of the ADSs andOrdinary Shares

The trading price of our ordinary sharesand ADSs may be volatile due to factors beyond our control, and purchasers of the ADSs could incur substantial losses.

The market prices of the ADSs and ordinary shares may be volatile. The stock market in general and the market for biotechnology companies in particular have experienced extreme volatility that has often been unrelated to the operating performance of particular companies. As a result of this volatility, investors may not be able to sell their ADSs or shares at or above the price originally paid for the security. The market price for the ADSs or shares may be influenced by many factors, including:

●	actual or anticipated fluctuations in our financial condition and operating results;
●	the release of new data from our PRIORITY or other clinical trials;
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●	actual or anticipated changes in our growth rate relative to our competitors;
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●	competition from existing products or new products that may emerge;
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●	announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures, collaborations or capital commitments;
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●	failure to meet or exceed financial estimates and projections of the investment community or that we provide to the public;
●	issuance of new or updated research or reports by securities analysts;
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●	fluctuations in the valuation of companies perceived by investors to be comparable to us;
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●	currency fluctuations;
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●	additions or departures of key management or scientific personnel;
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●	disputes or other developments related to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our technologies;
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●	changes to coverage policies or reimbursement levels by commercial third-party payors and government payors and any announcements relating to coverage policies or reimbursement levels;
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●	announcement or expectation of additional debt or equity financing efforts;
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●	issuances or sales of the ADSs or shares by us, our insiders or our other holders; and
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●	general economic and market conditions.
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These and other market and industry factors may cause the market price and demand for the ADSs or shares to fluctuate substantially, regardless of our actual operating performance, which may limit or prevent investors from readily selling their ADSs or shares and may otherwise negatively affect the liquidity of the trading market for ADSs or shares.

Certain of our significant shareholdersmay have different interests from us and may be able to control us, including the outcome of shareholder votes.

As of March 31, 2023, (i) MVM Partners LLP beneficially owned approximately 16.8% of our ordinary shares and has one representative at the board level (Dr. Eric Bednarski), (ii) Bleichroeder LP owned approximately 14.3% of our ordinary shares, (iii) Valiance Asset Management beneficially owned approximately 7.7% of our ordinary shares and has one representative at the board level (Jan Pensaert), and (iv) Biovest NV beneficially owned approximately 4.4% of our ordinary shares. In addition, as long as two of MVM Partners LLP’s funds (MVM V LP and MVM GP (No.5) LP) hold in aggregate 5% of our company’s outstanding shares, they are entitled to have one observer at the board level (see Item 7B. “Relatedparty transactions — MVM Subscription Agreement”). As a result, these shareholders will be able to exercise a significant level of control over all matters requiring stockholder approval, including the election of directors, amendment of our Articles of Association and approval of certain significant corporate transactions. This control could have the effect of delaying or preventing a change of control of the Company or changes in management, in each case, which other shareholders might find favorable, and will make the approval of certain transactions difficult or impossible without the support of these significant shareholders.

If securities or industry analysts do notpublish research or publish inaccurate or unfavorable research about our business, the price of the ADSs and ordinary shares and theirtrading volume could decline.

The trading market for the ADSs and ordinary shares depends in part on the research and reports that securities or industry analysts publish about us or our business. If no or only limited securities or industry analysts cover our company, the trading price for the ADSs and ordinary shares could be negatively impacted. If one or more of the analysts who covers us downgrades our equity securities or publishes inaccurate or unfavorable research about our business, the price of ADSs would likely decline. If one or more of these analysts ceases coverage of our company or fails to publish reports on us regularly, or downgrades our securities, demand for ADSs and ordinary shares could decrease, which could cause the price of the ADSs and ordinary shares or their trading volume to decline.

We intend to retain all available fundsand any future earnings and, consequently, ADS holders’ ability to achieve a return on their investment will depend on appreciationin the price of the ADSs.

We have never declared or paid any cash dividends on our ordinary shares or ADSs, and we intend to retain all available funds and any future earnings to fund the development and expansion of our business. In addition, our loan agreement with Innovatus limits our ability to pay any such dividends. Therefore, ADS holders are not likely to receive any dividends on your ADSs for the foreseeable future and the success of an investment in ADSs will depend upon any future appreciation in their value. Consequently, investors may need to sell all or part of their holdings of ADSs after price appreciation, which may never occur, as the only way to realize any future gains on their investment. There is no guarantee that the ADSs will appreciate in value or even maintain the price at which our investors have purchased them. Investors seeking cash dividends should not purchase the ADSs.

In addition, if we choose to pay dividends in the future, exchange rate fluctuations may affect the amount of Euros that we are able to distribute, and the amount in U.S. dollars that our shareholders receive upon the payment of cash dividends or other distributions we declare and pay in euros, if any. Any dividends will generally be subject to Belgian withholding tax. These factors could harm the value of the ADSs.

Holders of ADSs should be aware that therights provided to our ADS holders under Belgian corporate law and our Articles of Association differ in certain respects from the rightsthat you would typically enjoy as a shareholder of a U.S. company under applicable U.S. federal and state laws.

We are a Belgian public company with limited liability. Our corporate affairs are governed by our Articles of Association and by the laws governing companies incorporated in Belgium. The rights of shareholders and the responsibilities of members of our Board of Directors may be different from the rights and obligations of shareholders and boards of directors in companies governed by the laws of U.S. jurisdictions. In the performance of its duties, our Board is required by Belgian law to consider the interests of our company, its shareholders, its employees, and other stakeholders. It is possible that some of these parties will have interests that are different from, or in addition to, the interests of our shareholders. See Item 10B. “Memorandum and Articles of Association.”

Concentration of ownership of our ordinaryshares (including ordinary shares in the form of ADSs) among our existing executive officers, directors and principal shareholders mayprevent ADS holders from influencing significant corporate decisions.

Our executive officers, directors, greater than three percent shareholders and their affiliates beneficially owned approximately 45.2% of our outstanding ordinary shares as of March 31, 2023. Depending on the level of attendance at our general meetings of shareholders, these shareholders either alone or voting together as a group will be in a position to determine the outcome of decisions taken at any such general meeting. Any shareholder or group of shareholders controlling more than 50% of the share capital present and voting at our general meetings of shareholders may control any shareholder resolution requiring a simple majority, including the appointment of Board members, as well as certain decisions relating to our capital structure, the approval of certain significant corporate transactions and amendments to our Articles of Association. Among other consequences, this concentration of ownership may prevent or discourage unsolicited acquisition proposals that you may believe are in your best interest as one of our shareholders. Some of these persons or entities may have interests different than yours.

Future sales, or the perception of futuresales, of a substantial number of our ordinary shares could adversely affect the price of the ADSs, and actual sales of our equity willdilute ADS holders.

Future sales of a substantial number of our ADSs or ordinary shares, or the perception that such sales will occur, could cause a decline in the market price of the ADSs. Approximately 78.9 million ordinary shares (including ordinary shares underlying ADSs) held by our directors, executive officers and certain shareholders are subject to the lock-up agreements with terms generally expiring in May 2023. If, after the period during which such lock-up agreements restrict sales of the our ordinary shares and ADSs or if the underwriters of our initial public offering of ADSs waive the restrictions set forth therein (which may occur at any time), one or more of these securityholders sell substantial amounts of ordinary shares or ADSs in the public market, or the market perceives that such sales may occur, the market price of the ADSs and our ability to raise capital through an issue of equity securities in the future could be adversely affected.

If we issue ADSs or ordinary shares in futurefinancings, shareholders may experience dilution and, as a result, the price of the ADSs may decline.

We may from time-to-time issue additional ordinary shares at a discount from the trading price of the ADSs. As a result, holders of the ADSs would experience immediate dilution upon the issuance of any of our ordinary shares at such discount. In addition, as opportunities present themselves, we may enter into financing or similar arrangements in the future, including the issuance of debt securities, preference shares or shares. If we issue ordinary shares or other equity or equity-linked securities, holders of ADSs would experience additional dilution and, as a result, the price or the ADSs may decline.

It may be difficult for ADS holders outsideBelgium to serve process on, or enforce foreign judgments against, us or our directors and senior management.

We are a Belgian public limited liability company. Less than a majority of the members of our Board of Directors and members of our executive management team are residents of the United States. All or a substantial portion of the assets of such non-resident persons and most of our assets are located outside the United States. As a result, it may not be possible for ADS holders to effect service of process upon such persons or on us or to enforce against them or us a judgment obtained in U.S. courts. Original actions or actions for the enforcement of judgments of U.S. courts relating to the civil liability provisions of the federal or state securities laws of the United States are not directly enforceable in Belgium.

The United States and Belgium do not currently have a multilateral or bilateral treaty providing for reciprocal recognition and enforcement of judgments, other than arbitral awards, in civil and commercial matters. In order for a final judgment for the payment of money rendered by U.S. courts based on civil liability to produce any effect on Belgian soil, it is accordingly required that this judgment be recognized or be declared enforceable by a Belgian court in accordance with Articles 22 to 25 of the 2004 Belgian Code of Private International Law. Recognition or enforcement does not imply a review of the merits of the case and is irrespective of any reciprocity requirement. A U.S. judgment will, however, not be recognized or declared enforceable in Belgium, unless (in addition to compliance with certain technical provisions) the Belgian courts are satisfied of the following:

●	the effect of the enforcement judgment is not manifestly incompatible with Belgian public policy;
●	the judgment did not violate the rights of the defendant;
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●	the judgment was not rendered in a matter where the parties transferred rights subject to transfer restrictions with the sole purpose of avoiding the application of the law applicable according to Belgian international private law;
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●	the judgment is not subject to further recourse under U.S. law;
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●	the judgment is not incompatible with a judgment rendered in Belgium or with a subsequent judgment rendered abroad that might be recognized in Belgium;
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●	the claim was not filed outside Belgium after the same claim was filed in Belgium, while the claim filed in Belgium is still pending;
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●	the Belgian courts did not have exclusive jurisdiction to rule on the matter;
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●	the U.S. court did not accept its jurisdiction solely on the basis of the presence of the plaintiff or the location of goods not direct linked to the dispute in the United States;
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●	the judgment did not concern the deposit or validity of intellectual property rights when the deposit or registration of those intellectual property rights was requested, done or should have been done in Belgium pursuant to international treaties;
●	the judgment did not relate to the validity, operation, dissolution, or liquidation of a legal entity that has its main seat in Belgium at the time of the petition of the U.S. court;
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●	if the judgment relates to the opening, progress or closure of insolvency proceedings, it is rendered on the basis of the European Insolvency Regulation (EC Regulation No. 1346/2000 of May 29, 2000) or, if not, that (a) a decision in the principal proceedings is taken by a judge in the state where the most important establishment of the debtor was located or (b) a decision in territorial proceedings was taken by a judge in the state where the debtor had another establishment than its most important establishment; and
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●	the judgment submitted to the Belgian court is authentic under the laws of the state where the judgment was issued; in case of a default judgment, it can be shown that under locally applicable laws the invitation to appear in court was properly served on the defendant; a document can be produced showing that the judgment is, under the rules of the state where it was issued, enforceable and was properly served on the defendant.
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In addition to recognition or enforcement, a judgment by a federal or state court in the United States against us may also serve as evidence in a similar action in a Belgian court if it meets the conditions required for the authenticity of judgments according to the law of the state where it was rendered. The findings of a federal or state court in the United States will not, however, be taken into account to the extent they appear incompatible with Belgian public policy.

Based on the lack of a treaty as described above, U.S. investors may not be able to enforce against us or members of our Board of Directors or our executive management any judgments obtained in U.S. courts in civil and commercial matters, including judgments under the U.S. federal securities laws.

We are an “emerging growth company”and as a result of the reduced disclosure and governance requirements applicable to emerging growth companies, the ADSs may be less attractiveto investors.

We are an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). For as long as we continue to be an emerging growth company, we may take advantage of exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies, including not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”),, exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and shareholder approval of any golden parachute payments not previously approved. We may take advantage of these exemptions until we are no longer an emerging growth company. We could be an emerging growth company for up to five years, although circumstances could cause us to lose that status earlier, including if the aggregate market value of our ordinary shares held by non-affiliates exceeds $700 million as of the end of our second fiscal quarter before that time, in which case we would no longer be an emerging growth company as of the following December 31st (the last day of our fiscal year). We cannot predict if investors will find the ADSs less attractive because we may rely on these exemptions. If some investors find the ADSs less attractive as a result, there may be a less active trading market for the ADSs and the price of the ADSs may be more volatile.

As a foreign private issuer and as permittedby the listing requirements of Nasdaq, we rely on certain home country corporate governance practices rather than the corporate governancerequirements of Nasdaq.

We qualify as a foreign private issuer and our ADSs are listed on Nasdaq. In accordance with the listing requirements of Nasdaq, we rely on home country governance requirements and certain exemptions thereunder rather than relying on the corporate governance requirements of Nasdaq. For example, we are exempt from certain rules under the Exchange Act that regulate disclosure obligations and procedural requirements related to the solicitation of proxies, consents or authorizations applicable to a security registered under the Exchange Act, including the U.S. proxy rules under Section 14 of the Exchange Act. In addition, our officers and directors are exempt from the reporting and “short-swing” profit recovery provisions of Section 16 of the Exchange Act and related rules with respect to their purchases and sales of our securities. Moreover, while we currently publish annual and semi-annual reports on our website pursuant to the rules of Euronext Brussels and expect to file such financial reports with the SEC, we are not required to file periodic reports with the SEC as frequently or as promptly as U.S. public companies. Specifically, we are not required to file quarterly reports on Form 10-Q or current reports on Form 8-K that a domestic company would be required to file under the Exchange Act. Accordingly, there may be less publicly available information concerning our company than there would be if we were not a foreign private issuer.

In addition, the Listing Rules of the Nasdaq Stock Market require a majority of the directors of a listed U.S. company to be independent, whereas in Belgium, only three directors need to be independent. The Listing Rules of the Nasdaq Stock Market further require that each of the nominating, compensation and audit committees of a listed U.S. company be comprised entirely of independent directors. However, the Belgian Corporate Governance Code recommends only that a majority of the directors on the nomination committee meet the technical requirements for independence under Belgian corporate law. At present, our Audit Committee is composed of three independent directors out of three members, whereas our Nomination and Remuneration Committee is composed of three independent directors out of five members. Our Board of Directors has no plan to change the composition of our Audit Committee and Nomination and Remuneration Committee, and we intend to follow home country practice to the maximum extent possible. Therefore, our shareholders may be afforded less protection than they otherwise would have under corporate governance listing standards applicable to U.S. domestic issuers.

We may lose our foreign private issuer statusin the future, which could result in significant additional costs and expenses.

As a foreign private issuer, we are not required to comply with all the periodic disclosure and current reporting requirements of the Exchange Act and related rules and regulations. The determination of foreign private issuer status is made annually on the last business day of our most recently completed second fiscal quarter. Accordingly, we will next make a determination with respect to our foreign private issuer status on June 30, 2023. There is a risk that we will lose our foreign private issuer status in the future.

We would lose our foreign private issuer status if, for instance more than 50% of our ordinary shares are owned by U.S. residents or persons and more than 50% of our assets are located in the United States and we continue to fail to meet additional requirements necessary to maintain our foreign private issuer status. The regulatory and compliance costs to us under U.S. securities laws as a U.S. domestic issuer may be significantly greater than the costs we incur as a foreign private issuer. If we are not a foreign private issuer, we will be required to file periodic reports and registration statements on U.S. domestic issuer forms with the SEC, which are more detailed and extensive in certain respects than the forms available to a foreign private issuer. We would be required under current SEC rules to prepare our financial statements in accordance with U.S. GAAP and modify certain of our policies to comply with corporate governance practices associated with U.S. domestic issuers. Such conversion and modifications would involve additional costs. In addition, we may lose our ability to rely upon exemptions from certain corporate governance requirements on U.S. stock exchanges that are available to foreign private issuers, which could also increase our costs.

U.S. holders of ADSs may suffer adversetax consequences if we are characterized as a passive foreign investment company, or PFIC.

In general, a non-U.S. corporation is a PFIC for U.S. federal income tax purposes for any taxable year in which (i) 50% or more of value of its assets (based on an average of the quarterly values of the assets during such taxable year) consists of assets that produce, or are held for the production of, passive income, or (ii) 75% or more of its gross income consists of passive income. A separate determination must be made after the close of each fiscal year as to whether a non-U.S. corporation is a PFIC for that year. For purposes of the above calculations, a non-U.S. corporation that owns, directly or indirectly, at least 25% by value of the shares of another corporation is treated as if it held its proportionate share of the assets of the other corporation and received directly its proportionate share of the income of the other corporation. Passive income generally includes dividends, interest, investment gains and certain rents and royalties. Cash is generally a passive asset for these purposes. The value goodwill is generally treated as an active asset if it is associated with business activities that produce active income.

If we are a PFIC for any taxable year during which a U.S. Holder (as defined under Item 10E. “Taxation”) holds ADSs, we will continue to be treated as a PFIC with respect to such U.S. Holder in all succeeding years during which the U.S. Holder owns the ADSs regardless of whether we continue to meet the PFIC test described above, unless the U.S. Holder makes a specified election once we cease to be a PFIC. If we are classified as a PFIC for any taxable year during which a U.S. Holder holds ADSs, the U.S. Holder may be subject to adverse tax consequences regardless of whether we continue to qualify as a PFIC, including ineligibility for any preferred tax rates on capital gains or on actual or deemed dividends, interest charges on certain taxes treated as deferred, and additional reporting requirements.

Based on the current estimates, and expected future composition, of our income and the value of our assets, including goodwill, we do not expect to be a PFIC for our current taxable year. However, our PFIC status for any taxable year is an annual determination that can be made only after the end of that year and will depend on the composition of our income and assets and the value of our assets from time to time. The determination of whether we are a PFIC is fact-intensive and the applicable law is subject to varying interpretation. There can be no assurance that the U.S. Internal Revenue Service, or IRS, will agree with our position or that the IRS will not successfully challenge our position including our classification of certain income and assets as non-passive or our valuation of our tangible and intangible assets.

A U.S. Holder may in certain circumstances mitigate the adverse tax consequences of the PFIC rules by filing an election to treat the PFIC as a Qualified Electing Fund (“QEF”) or, if shares of the PFIC are “marketable stock” for purposes of the PFIC rules, by making a mark-to-market election with respect to the shares of the PFIC. However, we do not currently intend to provide the information necessary for U.S. Holders to make a QEF election if we were treated as a PFIC for any taxable year and prospective investors should assume that a QEF election will not be available. Furthermore, if a U.S. Holder were to make a mark-to-market election with respect to its ADSs, the U.S. Holder would be required to include annually in its U.S. federal taxable income (taxable at ordinary income rates) an amount reflecting any year end increase in the value of its ADSs. For further discussion of the PFIC rules and the adverse U.S. federal income tax consequences in the event we are classified as a PFIC, see Item 10E. “Taxation.”

The U.S. federal income tax rules relating to PFICs are very complex. Current and prospective U.S. Holders are strongly urged to consult their own tax advisors with respect to the impact of PFIC status on the purchase, ownership and disposition of ADSs, the consequences to them of an investment in a PFIC, any elections available with respect to the ADSs and the IRS information reporting obligations with respect to the purchase, ownership and disposition of ADSs of a PFIC.

If a U.S. Holder is treated as owning atleast 10% of our ordinary share capital, such holder may be subject to adverse U.S. federal income tax consequences.

If a U.S. Holder (as defined below under Item 10E. “Taxation”) is treated as owning, directly, indirectly or constructively, at least 10% of the value or voting power of our share capital, such U.S. Holder may be treated as a “U.S. shareholder” with respect to each “controlled foreign corporation” in our group, if any. Because our group currently includes at least one U.S. subsidiary, under current law, any of our current non-U.S. subsidiaries and any future newly formed or acquired non-U.S. subsidiaries will be treated as controlled foreign corporations, regardless of whether we are treated as a controlled foreign corporation. A U.S. shareholder of a controlled foreign corporation may be required to annually report and include in its U.S. taxable income its pro rata share of “Subpart F income,” “global intangible low-taxed income” and investments in U.S. property by controlled foreign corporations, regardless of whether we make any distributions. An individual that is a U.S. shareholder with respect to a controlled foreign corporation generally would not be allowed certain tax deductions or foreign tax credits that would be allowed to a U.S. shareholder that is a U.S. corporation. Failure to comply with controlled foreign corporation reporting obligations may subject a U.S. shareholder to significant monetary penalties. We cannot provide any assurances that we will furnish to any U.S. shareholder information that may be necessary to comply with the reporting and tax paying obligations applicable under the controlled foreign corporation rules of the Code. U.S. Holders should consult their tax advisors regarding the potential application of these rules to their investment in ADSs. See Item 10E. “Taxation” for a more detailed discussion.

We incur significant costs as a result ofoperating as a company that is publicly listed on both Nasdaq in the United States and Euronext Brussels in Belgium, and our managementis required to devote substantial time to new compliance initiatives.

As a U.S. public company listed on Nasdaq, we incur legal, accounting, and other expenses that we did not previously incur. We are subject to the reporting requirements of the Exchange Act, the Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act, the Nasdaq listing requirements and other applicable securities rules and regulations. Compliance with these rules and regulations will increase our legal and financial compliance costs, make some activities more difficult, time consuming or costly and increase demand on our systems and resources, particularly after we are no longer an “emerging growth company” and/or a foreign private issuer. The Exchange Act requires that, as a public company, we file annual, semi-annual and current reports with respect to our business, financial condition and result of operations. However, as a foreign private issuer, we are not required to file quarterly and current reports with respect to our business and results. We currently make annual and semi-annual reporting with respect to our listing on Euronext Brussels.

Moreover, these rules and regulations increase our legal and financial compliance costs and make some activities more time-consuming and costly. For example, we expect that these rules and regulations may make it more difficult and more expensive for us to obtain director and officer liability insurance, which in turn could make it more difficult for us to attract and retain qualified senior management personnel or members for our Board of Directors.

However, these rules and regulations are often subject to varying interpretations, in many cases due to their lack of specificity, and, as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies. This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices.

Further, being a U.S. listed company and a Belgian public company with shares admitted to trading on Euronext Brussels impacts the disclosure of information and requires compliance with two sets of applicable rules. From time to time, this may result in uncertainty regarding compliance matters and result in higher costs necessitated by legal analysis of dual legal regimes, ongoing revisions to disclosure and adherence to heightened governance practices. As a result of the enhanced disclosure requirements of the U.S. securities laws, business and financial information that we report is broadly disseminated and highly visible to investors, which we believe may increase the likelihood of threatened or actual litigation, including by competitors and other third parties, which could, even if unsuccessful, divert financial resources and the attention of our management from our operations.

As a result of being a U.S. public company,we are subject to regulatory compliance requirements, including Section 404 of the Sarbanes-Oxley Act (“Section 404”), andif we fail to maintain an effective system of internal controls, we may not be able to accurately report our financial results or preventfraud.

Pursuant to Section 404, our management is required to assess and attest to the effectiveness of our internal control over financial reporting in connection with issuing our consolidated financial statements as of and for each fiscal year. Section 404 also requires an attestation report on the effectiveness of internal control over financial reporting be provided by our independent registered public accounting firm beginning with our annual report following the date on which we are no longer an “emerging growth company”, which may be up to five fiscal years from the initial public offering of our ADSs.

The cost of complying with Section 404 significantly increases and management’s attention may be diverted from other business concerns, which could adversely affect our results. We may need to hire more employees in the future or engage outside consultants to comply with these requirements, which will further increase expenses. If we fail to comply with the requirements of Section 404 in the required timeframe, we may be subject to sanctions or investigations by regulatory authorities, including the SEC and Nasdaq. Furthermore, if we are unable to attest to the effectiveness of our internal control over financial reporting, we could lose investor confidence in the accuracy and completeness of our financial reports, and the market price of the ADSs could decline. Failure to implement or maintain effective internal control over financial reporting could also restrict our future access to the capital markets and subject each of us, our directors and our officers to both significant monetary and criminal liability. In addition, changing laws, regulations and standards relating to corporate governance and public disclosure are creating uncertainty for public companies, increasing legal and financial compliance costs and making some activities more time consuming. These laws, regulations and standards are subject to varying interpretations, in many cases due to their lack of specificity, and, as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies. This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices. We intend to invest resources to comply with evolving laws, regulations and standards, and this investment may result in increased general and administrative expense and a diversion of management’s time and attention from revenue generating activities to compliance activities. If our efforts to comply with new laws, regulations and standards differ from the activities intended by regulatory or governing bodies due to ambiguities related to their application and practice, regulatory authorities may initiate legal proceedings against us and our business, financial position, results and prospects may be adversely affected.

If we fail to implement and maintain effective internal controlsover financial reporting, our ability to produce accurate financial statements on a timely basis could be impaired.

We are subject to reporting obligations under U.S. securities laws and the Sarbanes-Oxley Act of 2002. Section 404 of the Sarbanes-Oxley Act requires that we include a report from management on the effectiveness of our internal control over financial reporting in our annual report on Form 20-F for the year ended December 31, 2022. If we fail to implement and maintain adequate disclosure controls and procedures, our management may conclude that our internal control over financial reporting is not effective. This conclusion could adversely impact the market price of the ADSs due to a loss of investor confidence in the reliability of our reporting processes.

In connection with the preparation of our financial statements for the nine months ended September 30, 2022, (the “Interim Financial Statements”), we identified a material weakness in our internal control over financial reporting at September 30, 2022 related to ineffective design and operation of our interim financial close and reporting controls. More specifically, internal control over financial reporting procedures used in connection with the preparation of the financial information that we reported in a press release issued on October 27, 2022 failed to identify a number of cut-off errors. These cut-off errors have been corrected in the Interim Financial Statements and do not relate to our year-end close and reporting controls. A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of a company’s annual or interim financial statements will not be prevented or detected on a timely basis. Although we were able to remediate these issues, including engaging an outside IFRS consulting firm to assist with our interim closing process, these efforts may not be sufficient to avoid similar material weaknesses in the future. Undetected material weaknesses in our internal controls could lead to financial statement restatements and require us to incur remediation costs. To the extent we experience additional future material weaknesses, investors could lose confidence in the accuracy or completeness of our reported financial information, which could have a negative effect on the trading price of the ADSs. Failure to implement or maintain effective internal control over financial reporting could also restrict our future access to the capital markets and subject each of us, our directors and our officers to both significant monetary and criminal liability.

We are required to perform system and process evaluations and testing of our internal controls over financial reporting, to allow our management and our independent public registered accounting firm to report on the effectiveness of our internal control over financial reporting. In addition, our compliance with Section 404 of the Sarbanes-Oxley Act will require that we incur substantial accounting expense, expend significant management effort and we may need to hire additional accounting and financial staff with the appropriate experience and technical accounting knowledge, and compile the system and process documentation necessary to perform the evaluation needed to comply with Section 404 of the Sarbanes-Oxley Act. We may not be able to complete our evaluation, testing and any required remediation in a timely fashion. Any failure to implement required new or improved controls, or difficulties encountered in their implementation could cause us to fail to meet our reporting obligations. In addition, any testing by us conducted in connection with Section 404 of the Sarbanes-Oxley Act, or any subsequent testing by our independent registered public accounting firm, may reveal additional deficiencies in our internal controls over financial reporting that are deemed to be material weaknesses or that may require prospective or retroactive changes to our financial statements or identify other areas for further attention or improvement. We cannot assure you that there will not be additional material weaknesses or significant deficiencies in our internal control over financial reporting in the future.

We may be subject to securities litigation,which is expensive and could divert management’s attention.

The market price of the ADSs may be volatile and, in the past, companies that have experienced volatility in the market price of their stock have been subject to securities class action litigation. We may be the target of this type of litigation in the future. Securities litigation against us could result in substantial costs and divert our management’s attention from other business concerns, which could seriously harm our business.

Investors resident in countries other thanBelgium may suffer dilution if they are unable to participate in future preferential subscription rights offerings.

Under Belgian law and our constitutional documents, shareholders have a waivable and cancellable preferential subscription right to subscribe pro rata to their existing shareholdings to the issuance, against a contribution in cash, of new shares or other securities entitling the holder thereof to new shares, unless such rights are limited or cancelled by resolution of our general shareholders’ meeting or, if so authorized by a resolution of such meeting, our Board of Directors. The exercise of preferential subscription rights by certain shareholders not residing in Belgium (including those in the United States, Australia, Israel, Canada or Japan as a result of the offering and taking into account the current shareholding and international network of our current Board of Directors) may be restricted by applicable law, practice or other considerations, and such shareholders may not be entitled to exercise such rights, unless the rights and shares are registered or qualified for sale under the relevant legislation or regulatory framework. In particular, we may not be able to establish an exemption from registration in the United States under the Securities Act of 1933, as amended (the “Securities Act”), and we are under no obligation to file a registration statement with respect to any such preferential subscription rights or underlying securities or to endeavor to have a registration statement declared effective under the Securities Act. Shareholders in jurisdictions outside Belgium who are not able or not permitted to exercise their preferential subscription rights in the event of a future preferential subscription rights, equity or other offering may suffer dilution of their shareholdings.

ADS holders may not be able to exercisetheir right to vote the ordinary shares underlying their ADSs.

ADS holders do not have the same rights as our shareholders. For example, ADS holders may not attend shareholders’ meetings or directly exercise the voting rights attaching to the ordinary shares underlying their ADSs. ADS holders may vote only by instructing the depositary to vote on their behalf. If we request the depositary to solicit your voting instructions (and we are not required to do so), the depositary will notify you of a shareholders’ meeting and send or make voting materials available to you. Those materials will describe the matters to be voted on and explain how ADS holders may instruct the depositary how to vote. For instructions to be valid, they must reach the depositary by a date set by the depositary. The depositary will try, as far as practical, to vote or to have its agents vote the deposited ordinary shares as instructed by ADS holders. If we do not request the depositary to solicit ADS holders’ voting instructions, ADS holders can still send voting instructions, and, in that case, the depositary may try to vote as the ADS holder instructs, but it is not required to do so. Except by instructing the depositary as described above, ADS holders will not be able to exercise voting rights unless the ADS holder surrenders the ADS holder’s ADSs and withdraw the ordinary shares. However, ADS holders may not know about the meeting enough in advance to withdraw the ordinary shares. We cannot assure ADS holders that they will receive the voting materials in time to ensure that they can instruct the depositary to vote their ordinary shares. In addition, the depositary and its agents are not responsible for failing to carry out voting instructions or for the manner of carrying out voting instructions. This means that ADS holders may not be able to exercise voting rights and there may be nothing an ADS holder can do if the ADS holder’s ordinary shares are not voted as the ADS holder requested. In addition, ADS holders have no right to call a shareholders’ meeting.

Holders of ADSs may be subject to limitationson the transfer of their ADSs and the withdrawal of the underlying ordinary shares.

ADSs, which may be evidenced by American Depositary Receipts, are transferable on the books of the depositary. However, the depositary may close its books at any time or from time to time when it deems expedient in connection with the performance of its duties. The depositary may refuse to deliver, transfer or register transfers of ADSs generally when our books or the books of the depositary are closed, or at any time if we or the depositary think it is advisable to do so because of any requirement of law, government or governmental body, or under any provision of the deposit agreement, or for any other reason subject to a holder of ADSs’ right to cancel his or her ADSs and withdraw the underlying ordinary shares as specified in the deposit agreement. Temporary delays in the cancellation of ADSs and withdrawal of the underlying ordinary shares may arise because the depositary has closed its transfer books or we have closed our transfer books, in connection with voting at a shareholders’ meeting or we are paying a dividend on our ordinary shares. In addition, a holder of ADSs may not be able to cancel his or her ADSs and withdraw the underlying ordinary shares when he or she owes money for fees, taxes and similar charges and when it is necessary to prohibit withdrawals in order to comply with any laws or governmental regulations that apply to ADSs or to the withdrawal of ordinary shares or other deposited securities. See Item 12D. “American Depositary Shares.”

ADS holders may not be entitled to a jurytrial with respect to claims arising under the deposit agreement, which could result in less favorable outcomes to the plaintiffs in anysuch action.

The deposit agreement governing the ADSs representing our ordinary shares provides that, to the fullest extent permitted by law, ADS holders, including holders who acquire ADSs in the secondary market, waive the right to a jury trial of any claim they may have against us or the depositary arising out of or relating to our shares, the ADSs or the deposit agreement, including any claim under the U.S. federal securities laws.

If we or the depositary opposed a jury trial demand based on the waiver, the court would determine whether the waiver was enforceable based on the facts and circumstances of that case in accordance with the applicable state and federal law. To our knowledge, the enforceability of a contractual pre-dispute jury trial waiver in connection with claims arising under the federal securities laws has not been finally adjudicated by the U.S. Supreme Court. However, we believe that a contractual pre-dispute jury trial waiver provision is generally enforceable, including under the laws of the State of New York, which govern the deposit agreement, by a federal or state court in the City of New York, which has non-exclusive jurisdiction over matters arising under the deposit agreement. In determining whether to enforce a contractual pre-dispute jury trial waiver provision, courts will generally consider whether a party knowingly, intelligently and voluntarily waived the right to a jury trial. We believe that this is the case with respect to the deposit agreement and the ADSs. It is advisable that you consult legal counsel regarding the jury waiver provision before entering into the deposit agreement.

If any owners or holders of ADSs bring a claim against us or the depositary in connection with matters arising under the deposit agreement or the ADSs, including claims under federal securities laws, such other holder or beneficial owner may not be entitled to a jury trial with respect to such claims, which may have the effect of limiting and discouraging lawsuits against us and the depositary. If a lawsuit is brought against either or both of us and the depositary under the deposit agreement, it may be heard only by a judge or justice of the applicable trial court, which would be conducted according to different civil procedures and may result in different outcomes than a trial by jury would have, including results that could be less favorable to the plaintiffs in any such action.

Nevertheless, if this jury trial waiver provision is not permitted by applicable law, an action could proceed under the terms of the deposit agreement with a jury trial. No condition, stipulation or provision of the deposit agreement or ADSs serves as a waiver by any owner or holder of ADSs or by us or the depositary of compliance with U.S. federal securities laws and the rules and regulations promulgated thereunder.

Takeover provisions in the national lawof Belgium may make a takeover difficult.

Public takeover bids on our shares and other voting securities, such as warrants or convertible bonds, if any, are subject to the Belgian Act of April 1, 2007 on public takeover bids, as amended and implemented by the Belgian Royal Decree of April 27, 2007, or Royal Decree, and to the supervision by the Belgian Financial Services and Markets Authority, or FSMA. Public takeover bids must be made for all of our voting securities, as well as for all other securities that entitle the holders thereof to the subscription to, the acquisition of or the conversion into voting securities. Prior to making a bid, a bidder must issue and disseminate a prospectus, which must be approved by the FSMA. The bidder must also obtain approval of the relevant competition authorities, where such approval is legally required for the acquisition of our company. The Belgian Act of April 1, 2007 provides that a mandatory bid will be required to be launched for all of our outstanding shares and securities giving access to shares if a person, as a result of its own acquisition or the acquisition by persons acting in concert with it or by persons acting on their account, directly or indirectly holds more than 30% of the voting securities in a company that has its registered office in Belgium and of which at least part of the voting securities are traded on a regulated market or on a multilateral trading facility designated by the Royal Decree. The mere fact of exceeding the relevant threshold through the acquisition of one or more shares will give rise to a mandatory bid, irrespective of whether or not the price paid in the relevant transaction exceeds the current market price.

There are several provisions of Belgian company law and certain other provisions of Belgian law, such as the obligation to disclose important shareholdings and merger control, that may apply to us and which may make an unfriendly tender offer, merger, change in management or other change in control, more difficult. These provisions could discourage potential takeover attempts that third parties may consider and thus deprive the shareholders of the opportunity to sell their shares at a premium (which is typically offered in the framework of a takeover bid).

ITEM 4. INFORMATION ON THE COMPANY

A. History and Development of the Company

Our capital expenditures for the years ended December 31, 2020, 2021 and 2022 amounted to $540,000, $1.2 million and 2.8 million, respectively. These capital expenditures primarily consisted of laboratory equipment, information technology equipment, and leasehold improvements. To date, we have expensed all research and development costs as incurred, as we do not currently meet the conditions to capitalize expenditures on drug development activities, as provided in IAS 38 Intangible Assets. Our research and development costs for the years ended December 31, 2020, 2021 and 2022 amounted to $4.5 million, $6.7 million and $7.6 million, respectively. These research and development costs primarily consisted of expenses incurred in connection with the development of our pipeline products, such as labor costs (including salaries, bonuses, benefits, and stock-based compensation), reagents and supplies, clinical studies, outside services, patent expenses, depreciation of laboratory equipment, facility occupancy and information technology costs. We expect that our research and development expenses will increase in absolute dollars as we continue to develop additional products, however, we expect that these expenses will decrease as a percentage of revenue over the long term, though they may fluctuate as a percentage from period to period due to the timing and extent of these expenses. For the near future, our investments will mainly remain in the United States where our molecular laboratory facility is currently located.

The SEC maintains a website that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC at http://www.sec.gov. We also maintain a website at http://www.mdxhealth.com/. The reference to our website is an inactive textual reference only and the information contained in, or that can be accessed through, our website or any other website cited in this annual report is not a part of this annual report.

B. Business Overview

Overview

We are a commercial-stage precision diagnostics company committed to providing non-invasive, clinically actionable and cost-effective urologic solutions to improve patient care. Our novel genomic testing solutions combine advanced clinical modeling with genomic data to provide each patient with a personalized risk profile, which provides more accurate and actionable information than traditional clinical risk factors used by clinicians. Our Select mdx and Confirm mdx tests address men at risk for undetected prostate cancer, providing physicians with a clear clinical pathway to accurately identify clinically significant prostate cancer while reducing the use of invasive procedures that are prone to complications. Our GPS test addresses men newly diagnosed with localized prostate cancer, providing physicians with a clear clinical pathway to make the most informed treatment decision for their individual disease. Our team’s collective decades of experience in precision diagnostics and our portfolio of novel biomarkers for diagnostic, prognostic and predictive molecular assays supports our active pipeline of new testing solutions for urologic diseases.

Prostate cancer is presently the most common, and second deadliest, form of cancer in men. The broad adoption of prostate-specific antigen (“PSA”) screening in the 1980s created a paradigm shift in men’s health, reducing the incidence of metastatic prostate cancers by more than 50%. However, widespread PSA testing also significantly increased the pool of symptomatic men, resulting in overdiagnosis, overtreatment, serious complications, and potential anxiety — triggering a retreat from standardized PSA screening — culminating with the decision of the U.S. Preventative Services Task Force’s (“USPSTF”) to recommend against all PSA testing and prostate cancer screening in 2012. Following recommendations from clinicians and patient advocates together with building evidence of an uptick in metastatic prostate cancer incidence, the USPSTF softened its position in 2017, upgrading PSA screening for middle-aged men. However, the USPSTF’s reversal left unresolved the clinical dilemma posed by the estimated pool of over ten million men living with an elevated PSA in the United States. Approximately 25 million PSA tests are performed each year, and over 15% of these reveal heightened PSA levels — leading to an estimated pool of over three million undiagnosed men informed each year of their heightened risk for prostate cancer based on elevated PSA test results and/or negative biopsy results. Other than repeated invasive needle biopsy procedures, these symptomatic men and their clinicians have limited tools to manage their cancer risk.

Our Select mdx and Confirm mdx testing solutions directly address this unmet clinical need. Since the commercial launch of Confirm mdx in 2012 and Select mdx in 2016, we have performed over 200,000 tests ordered by more than 1,000 urologists in the United States. Select mdx for Prostate Cancer (a urine test for men being considered for their first prostate biopsy) and Confirm mdx for prostate cancer (an epigenetic test for men post-prostate biopsy), are designed to (i) improve the earlier detection of clinically significant prostate cancer in at-risk men and (ii) reduce the unnecessary costs and patient anxiety associated with the diagnosis and treatment of the disease. Both tests have been included in the National Comprehensive Cancer Network (“NCCN”) Guidelines for the Early Prostate Cancer Detection. NCCN is a non-profit alliance of the 31 leading cancer centers in the United States. Both tests have also successfully completed formal technical assessment review for Medicare reimbursement and have received a positive final local coverage determination (“LCD”).

While our existing prostate cancer tests, Select mdx and Confirm mdx, improve the decision for biopsy in at-risk patients, our recently acquired GPS test moves us further into the cancer management pathway, providing solutions for patients newly diagnosed with localized prostate cancer to make the most informed treatment decision for their individual disease. Our acquisition of the GPS (formerly Oncotype DX GPS) prostate cancer business in August 2022 from Genomic Health, Inc., a subsidiary of Exact Sciences, has accelerated our plans to build on our leadership in the urologic diagnostic space.

Currently, most newly diagnosed cases of prostate cancer remain indolent — slow growing and non-lethal. Patients diagnosed with indolent prostate cancer may be appropriately managed with observation or active surveillance (“AS”), while those with aggressive cancers may benefit from immediate treatment. Practice-management agencies worldwide have implemented guidelines stressing the importance of discerning favorable from unfavorable disease features to guide personalized management for patients diagnosed with low- and high-risk prostate cancer, including among others NCCN, the American Urology Association, American Society for Radiation Oncology, Society of Urologic Oncology, the American Society of Clinical Oncology, the National Institute for Health and Care Excellence, and the European Association of Urology (“EAU”). The use of AS has increased in recent years, with approximately half of patients newly diagnosed with localized prostate cancer choosing to avoid immediate intervention or similar treatment.

GPS is a tissue-based, multi-gene test that has been clinically validated to predict aggressive cancer at the time of diagnosis, helping to identify those men who need immediate surgery or radiation therapy versus those who can confidently choose AS. Since its commercial launch in 2013, over 100,000 GPS tests have been performed, ordered by more than 3,000 urologists in the United States. GPS is able to provide a more precise and accurate assessment of disease progression, which helps more men avoid the lifelong complications associated with aggressive treatments. In 2015 our GPS test received a positive Medicare LCD under the MolDX Program, which provides coverage and reimbursement for Medicare beneficiaries throughout the United States.

Building from the foundation of our complementary marketed products, we are committed to sustained growth, with our core management principles defined by a commitment to focus, commercial execution and operating discipline throughout our organization. While MDxHealth is domiciled and listed as a public company in Belgium, our primary commercial focus is the United States, where over 95% of our tests are performed and revenues are generated. Our leadership change in 2019 and coincident organizational and operational discipline implemented throughout the MDxHealth group of companies has further focused our commitment to U.S.-sourced growth, with our entire executive management team and over 90% of staff based in or reporting to our U.S. headquarters and laboratories.

We have established a systematic approach to commercializing our precision diagnostic solutions in our target markets in the United States, focusing on active engagement, education and market development directed toward health care professionals and their patients. Our commercial team is focused on prioritizing large and high-volume community urology centers, and on building long-standing relationships with key physicians and practice groups who have strong connections to the population of men who may be eligible for our solutions. Our ultimate goal is to support physicians using our tests through all aspects of the patient’s journey, starting from initial diagnosis through to advanced prostate cancer management. We also seek to build on our long-term partnerships with key opinion leaders (“KOLs”) and patient associations that are oriented towards the needs of our patients and customers. Our sales and marketing organization is focused on building physician awareness of the clinical and economic benefits provided by our tests through education of urologists and their clinical staff as well as pathology and laboratory staff, targeted KOL development and training, and development of tools for our customers to interact with patients and consumers (doctor-to-consumer education).

Our Product Portfolio

Our core commercial tests address a substantial unmet clinical need in the prostate cancer diagnostic and treatment pathway. According to the American Cancer Society, prostate cancer is the most common, and second deadliest, form of cancer in males in the United States. Prior to the emergence of precision diagnostic solutions, existing diagnostic tests were critically flawed, with high false negatives and false positives, leading to costly and invasive diagnostic protocols and attendant complications.

To screen at-risk men for prostate cancer, approximately 25 million PSA tests are performed each year, and over 15% of those reveal heightened levels of PSA. An elevated PSA level can be caused by many different sources, the majority of which are not cancer. Current clinical guidelines suggest that men with an elevated PSA should be considered for a prostate biopsy, so that a pathologist can visually inspect the sampled tissue to identify any sign of malignancy. However, 60% of biopsies are negative, not revealing any cancer, and as many as a third of these negative biopsies are false negatives, providing limited comfort to patients and their physicians that cancer was not missed. The relatively modest sensitivity and specificity of these current standard-of-care tests and procedures has led to increased patient anxiety, potentially unnecessary, invasive and costly interventions, and increased complications and hospitalizations.

Our Select mdx test — which is a noninvasive urine test with 95% Negative Predictive Value (“NPV”) for clinically significant prostate cancer — can be used to help physicians determine whether a costly, painful and complication-prone needle-core biopsy is advisable when a patient presents with an elevated PSA level or an abnormal digital rectal exam (“DRE”). For those men who proceed to a biopsy procedure, our Confirm mdx test, which measures biomarker signals in the biopsied tissue, provides additional information to physicians and increases the accuracy of the biopsy, with a 96% NPV for clinically significant disease.

Upon an initial diagnosis of localized prostate cancer, our GPS test — which measures the expression of a panel of genes in prostate cancer tissue to predict the aggressiveness of the disease — can help distinguish between aggressive and indolent prostate cancer, which informs treatment decisions and helps to identify patients who may avoid unnecessary interventions.

To further supplement our prostate cancer menu, with Resolve mdx we have developed a novel, advanced urinary tract infection (“UTI”) test that delivers patient-specific antimicrobial treatment options within 24-48 hours (standard urine cultures can take up to 5 to 7 days). Developed especially for patients with recurrent, persistent, and complicated UTIs, Resolve mdx combines precise pathogen identification and resistance gene detection with a proprietary susceptibility methodology that identifies personalized oral antibiotic options for fast resolution and improved patient outcomes.

Our Competitive Strengths

We believe we have the following competitive strengths, which underpin our commercial execution success and will position us for sustainable growth:

●	Targeted Menu Improving Prostate Cancer Diagnosis and Treatment. We offer a menu of tests that<br> provide clinically actionable results for men at-risk for, as well as men newly diagnosed<br> with, prostate cancer. Collectively, Select mdx, Confirm mdx and GPS provide urologists with<br> a clear clinical pathway to accurately identify and appropriately treat prostate cancer while<br> minimizing the use of aggressive procedures and treatments, improving health outcomes and<br> significantly lowering costs to the healthcare system.
●	Strong Commercial Focus and Presence. We aim to increase adoption of our commercial tests by<br> leveraging our direct sales force in the United States to continue to market and sell to<br> our urology-focused network. We have significant experience in building effective commercial<br> teams consisting of sales reps, strategic account managers, and clinical liaisons led by<br> a management team with a track record of success. In addition, our payor and reimbursement,<br> revenue cycle management and client services groups provide expert support for our field<br> sales team as well as our patients and customer base. We believe we can leverage these groups<br> to explore additional opportunities for growth based on this commercial channel. Outside<br> the United States, we will continue to evaluate distribution partners to drive adoption in<br> markets where our menu is best suited.
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●	Commercial Channel Advantage. Building from the launch of our first commercial test in 2012, we<br> have established MDxHealth as an industry leader in precision diagnostics for prostate cancer<br> detection and treatment. We intend to take advantage of our established urology and pathology<br> relationships to support menu expansion and additional growth opportunities as appropriate<br> and within our focus.
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●	Compelling Reimbursement Strategy. Adoption of our Confirm mdx, Select mdx and GPS tests has been<br> supported by LCDs issued via the MolDX Program, their inclusion in NCCN and other U.S. and<br> internationally recognized clinical-practice guidelines, as well as consistent expansion<br> of coverage by commercial payors. Our Resolve mdx UTI test is currently reimbursed by Medicare<br> and most private insurance payors, based on nationally recognized Current Procedural Terminology<br> (“CPT”) codes.
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●	Robust and Reliable Technology. We possess a proprietary know-how and intellectual property<br> portfolio capable of advancing our precision diagnostics pathway as well as high quality<br> laboratory operations, including our CAP accredited, CLIA certified and New York State Department<br> of Health (“NYSDOH”) approved molecular laboratory facilities. We<br> also have an extensive library of biomarkers that can be applied in additional urology and<br> men’s health diagnostics.
●	Proven Leadership with Industry Expertise. Our management team members have proven track records<br> of execution and value creation across medical devices, diagnostics and biotech. We believe<br> we have built a culture of performance, responsibility and accountability — from research<br> and development, to sales and marketing, and operations and management — and are committed<br> to building value for all of our stakeholders, including patients, customers, employees and<br> shareholders.
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Robust and Reliable Technology. We possess a proprietary know-how and intellectual property portfolio capable of advancing our precision diagnostics pathway as well as high quality laboratory operations, including our CAP accredited, CLIA certified and New York State Department of Health (“NYSDOH”) approved molecular laboratory facilities. We also have an extensive library of biomarkers that can be applied in additional urology and men’s health diagnostics.

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Proven Leadership with Industry Expertise. Our management team members have proven track records of execution and value creation across medical devices, diagnostics and biotech. We believe we have built a culture of performance, responsibility and accountability — from research and development, to sales and marketing, and operations and management — and are committed to building value for all of our stakeholders, including patients, customers, employees and shareholders.

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Our Strategy

Our ultimate goal with our core testing solutions is to take an at-risk patient from prostate cancer screening all the way through the diagnostic and therapeutic pathway of prostate cancer. As such, we are focused on continuing to drive adoption of our Select mdx, Confirm mdx, and GPS tests and expand our product offerings. The key elements of our strategy include:

●	Physician and Patient Education. One important component of our efforts to successfully penetrate<br> the urology market and promote clinical adoption of our Select mdx, Confirm mdx, GPS and<br> Resolve mdx tests is to drive awareness of these tests. We educate physicians and patients<br> through a variety of channels including by supporting clinical studies for the publication<br> of peer reviewed journals and abstracts at key scientific conferences, forging relationships<br> with the leading medical and scientific opinion leaders in urology, developing strategic<br> partnerships with leading pathology laboratories with large urology client bases and via<br> public relations and advertising campaigns.
●	Expand Test Menu. We intend to build on our leadership in the prostate cancer diagnostic space<br> by expanding our existing menu of tests. We are currently developing a candidate test, Monitor<br> mdx, for the prostate cancer diagnostic and treatment pathway. Monitor mdx is<br> intended to function as a non-invasive solution that risk stratifies patients for continued<br> AS versus intervention, while also improving patient compliance with AS protocols.
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●	Expand Reimbursement. An important component of our commercial strategy is to expand reimbursement<br> for our tests. Our Select mdx, Confirm mdx and GPS tests have been covered by a Medicare<br> MoIDX LCD since 2023, 2014 and 2015, respectively. Our managed care team continues to pursue<br> adoption of positive coverage and reimbursement policies and contracts by other payors. We<br> believe the clinical utility and actionability of our tests, combined with our experience<br> and knowledge of the complex coverage and reimbursement landscape in the United States, will<br> enable us to expand coverage and reimbursement among the commercial payor market. We continue<br> to build upon our successful strategy, supported by governmental and commercial coverage<br> policies, as a foundation to secure additional contracts from major payors.
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Market Opportunity

Among U.S. males, prostate cancer is the most diagnosed cancer and the second leading cause of cancer death. According to the American Cancer Society, in 2023, over 280,000 men are expected to be diagnosed with prostate cancer in the United States, with more than 34,000 dying from the disease.

There are currently significant challenges with diagnosing and treating prostate cancer in the United States. Approximately 25 million PSA tests are performed each year, and over 15% of those reveal heightened levels of PSA. Current clinical guidelines suggest that men with an elevated PSA should be considered for a prostate biopsy, However, approximately 60% of biopsies are negative, not revealing any cancer, and as many as a third of these negative biopsies are false negatives, providing limited comfort to patients and their physicians that cancer was not missed. For those men whose biopsies are positive, the majority will harbor indolent cancer, but traditional methods are unable to accurately identify which of these men might safely avoid invasive and costly interventions. In addition, for patients diagnosed with localized prostate cancer who are on AS, management of their disease relies on the measurement of PSA levels and DRE results, which can be unreliable and lead to overdiagnosis and overtreatment.

The relatively modest sensitivity, specificity and prognostic ability of current standard-of-care tests and procedures has led to increased patient anxiety, potentially unnecessary, invasive and costly interventions, and increased complications and hospitalizations. Our suite of commercial products addresses these issues, presenting a substantial market opportunity. The Company has calculated approximate addressable market opportunities for our menu of tests, based on the estimated:

●	3<br> million men screened for prostate cancer annually;
●	500,000<br> men who undergo prostate biopsies annually;
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●	268,000<br> men diagnosed prostate cancers annually; and
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●	2<br> million UTI cases managed by urologists annually.
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* Resolve mdx test in development (all figures based on management estimates).

Commercial Products

Select mdx for Prostate Cancer Urine Test

The current standard for prostate cancer screening is the PSA blood test. Unfortunately, the PSA is not specific to clinically significant prostate cancer — it is more of an indicator of prostate health. There are many factors such as benign prostatic hyperplasia, inflammation, prostatitis and a naturally occurring enlarged prostate that can cause an elevated PSA. In men with an elevated PSA level between 3-10 ng/mL, only 25-40% of biopsies reveal cancer — and the majority of these identified cancers are indolent. Also, following a prostate biopsy procedure, around 18% of men suffer complications (blood in urine) and around 3% are hospitalized for infection (sepsis). Select mdx helps physicians determine if a patient is at higher or lower risk for prostate cancer and which men can safely avoid biopsy.

Select mdx is a non-invasive urine test that measures the expression of two mRNA cancer-related biomarkers (HOXC6 and DLX1) combined with an advanced clinical model incorporating traditional risk factors. The test provides a personalized risk profile that helps the physician determine whether:

●	The patient may<br> benefit from a biopsy and early prostate cancer detection; or
●	The patient can<br> avoid a biopsy and return to routine screening.
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Men identified by the test as having a high likelihood of clinically significant cancer can, upon biopsy, be diagnosed and treated sooner, while men identified at very low risk may avoid biopsy.

The following chart depicts the functioning of the Select mdx test:

Guidelines Inclusion

Select mdx has been included in the NCCN Prostate Cancer Early Detection guidelines since 2020. Select mdx has also been included in the EAU Prostate Cancer guidelines since 2018.

Clinical Validation Studies

The use of Select mdx as a predictive test to identify men at low risk for aggressive prostate cancer has been well validated in both scientific and clinical studies.

Results from the clinical validation study for Select mdx confirmed its superior performance compared to other commonly used biomarker tests and risk calculators. The test’s NPV of 95% in the validation study means that if the test identifies a very low risk, the physician and patient can be 95% sure that a subsequent biopsy will not detect Gleason score ≥7 prostate cancer, information that may provide a level of confidence needed to avoid a biopsy. The test has a very high predictive accuracy (AUC 0.85) for high-grade prostate cancer, which is significantly better than the Prostate Cancer Prevention Trial Risk Calculator (“PCPTRC”) version 2.

There are twelve published studies assessing the Select mdx test and which together demonstrate its analytical validity, clinical validity, clinical utility and positive health economic outcomes. These studies, all of which have been published in peer-reviewed publications, evaluated more than 4,500 patients in the aggregate.

The following is a summary that highlights key findings from some of these studies.

●	Analytical validity. A study published in 2017 illustrated, in an independent laboratory, the performance characteristics and robustness<br> of the Select mdx mRNA assay, covering all aspects of analytical method validation including assay sensitivity, specificity, linearity,<br> precision, repeatability and reproducibility using pre-specified acceptance criteria.

●	Clinical validity. In a study published in 2019, the Select mdx test demonstrated an NPV of 95%. Urine samples were collected from 1,955<br> men from The Netherlands, France and Germany prior to an initial prostate biopsy. Select mdx molecular biomarker results were combined<br> with other risk factors in a clinical model optimized to detect International Society of Urological Pathology Grade Group 2 or greater<br> prostate cancer in men. Results in the validation cohort were compared with the independent PCPT risk calculator version 2. The full<br> validation cohort of 916 men including all prostate specific antigen levels yielded an AUC of 0.85 with 93% sensitivity, 47% specificity<br> and 95% negative predictive value. The PCPTRC AUC was 0.76. In the 715-patient validation cohort, limited to subjects with PSA less<br> than 10 ng/ml, the AUC was 0.82 with 89% sensitivity, 53% specificity and 95% negative predictive value. The PCPTRC AUC was 0.70.
●	Clinical utility. In a 2019 study, Select mdx had a significant impact on initial prostate biopsy decision-making in a U.S. community<br> urology setting. Biopsy rates in Select mdx positive men were 5-fold higher than in Select mdx negatives.
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●	Health economic outcomes. A 2018 study demonstrated that routine use of the Select mdx test to guide biopsy decision making improved<br> health outcomes and significantly lowered costs in American men at risk for prostate cancer. Compared to the current standard of<br> care, Select mdx implementation would result in an average of 0.045 quality-adjusted life years (“QALYs”) gained at a<br> cost savings of $1,694 per patient. Assuming approximately 300,000 men are biopsied each year, this translates to an incremental<br> 14,000 QALYs gained at cost savings of $500,000 annually.
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Confirm mdx for Prostate Cancer TissueTest

Approximately 30% of men with a cancer-negative prostate biopsy actually have cancer. Prostate cancer is difficult to diagnose because it is both heterogenous and multi-focal. The standard of care for diagnosing prostate cancer is a transrectal ultrasound guided biopsy. However, this procedure samples less than 1% of the entire gland, leaving men at risk for undetected prostate cancer.

Confirm mdx is a well-validated epigenetic test that guides the detection of occult prostate cancer on a patient’s previously biopsied negative tissue. The test can help urologists determine a man’s risk for harboring clinically significant prostate cancer despite having a cancer-negative biopsy result, and it has a number of unique features/advantages.

For patients with an initial negative biopsy, few options are currently available to guide an urologist in determining whether or when an additional biopsy procedure is warranted. Fear of occult (hidden) prostate cancer leads to additional procedures, leading many men to receive multiple follow-up biopsy procedures to rule out the presence of cancer.

The Confirm mdx test addresses prostate biopsy sampling concerns, helping urologists to:

●	“Rule-out”<br> men from undergoing potentially unnecessary repeat biopsies and screening procedures, helping<br> to reduce complications, patient anxiety and excessive healthcare expenses associated with<br> these procedures; and
●	“Rule-in”<br> high-risk men with a previous negative biopsy result who may be harboring undetected cancer<br> (false negative biopsy result) and therefore may benefit from a repeat biopsy and potentially<br> treatment.
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For men with a negative biopsy, independently published clinical studies have shown that the Confirm mdx test is the most significant, independent predictor of prostate biopsy outcomes relative to other available clinical factors such as age, PSA and DRE results. Incorporating Confirm mdx into clinical practice can reduce the number of unnecessary repeat biopsies, yielding clinical and economic value for healthcare providers, patients and payors. Confirm mdx can aid urologists with patient management decisions regarding the need for follow-up testing and procedures with the identification of low-risk patients testing negative for DNA hypermethylation.

The use of Confirm mdx for prostate cancer detection using methylation-specific PCR (“MSP”) and cancer-associated epigenetic biomarkers to improve upon histopathology has been well validated in both scientific and clinical studies. DNA methylation, the most common and useful measure of epigenetic abnormality testing, is responsible for the silencing of key tumor suppressor genes. DNA methylation biomarkers associated with prostate cancer have been extensively evaluated.

GSTP1 is a widely studied and reported epigenetic biomarker associated with prostate cancer diagnosis, encoding the glutathione S-transferase Pi 1 (GSTP1) protein involved in detoxification, due to its high sensitivity and specificity. Complementing GSTP1, methylation of the APC and RASSF1 genes is frequently found in prostate cancer, and these markers have demonstrated a “field effect” aiding in the identification of biopsies with false-negative histopathological results.

The epigenetic field effect is a molecular mechanism whereby cells adjacent to cancer foci can contain DNA methylation changes, which may be indistinguishable by histopathology, but detectable by MSP testing. The presence of epigenetic field effects associated with prostate cancer has been widely published and is the basis of activity for the Confirm mdx assay to aid in the detection of occult prostate cancer on previously biopsied, histopathologically negative tissue.

The following image depicts how the Confirm mdx test identifies false-negative biopsies:

Confirm mdx Field Effect

Guidelines Inclusion

Confirm mdx has been included in the NCCN Prostate Cancer Early Detection guidelines since 2016. Confirm mdx has also been included in the EAU Prostate Cancer guidelines since 2018.

Confirm mdx Clinical Validation Studies

The use of Confirm mdx for prostate cancer detection to improve upon histopathology has been well validated in both scientific and clinical studies.

There are more than 55 published studies on the genes and technology used in the Confirm mdx test. Among these, studies demonstrating the analytical validity, clinical validity, clinical utility and positive health economic outcomes of the Confirm mdx test evaluated more than 1,200 patients in the aggregate.

The following is a summary that highlights key findings from some of these studies.

●	Analytical validity. A study published in 2012 illustrated the performance characteristics and robustness of the Confirm mdx multiplex<br> DNA methylation assay, covering the analytical method including assay sensitivity, specificity, linearity, precision, repeatability<br> and reproducibility using pre-specified acceptance criteria.
●	Clinical validity. The clinical validity of the Confirm mdx test has been demonstrated in two large, blinded clinical validation studies<br> published in 2013 and 2014, yielding a NPV of ~90% for all prostate cancer, which is significantly higher (p < 0.001) than that<br> afforded by standard histopathology review, as well as a NPV of 96% for clinically significant prostate cancer. Further, when compared<br> to all pertinent risk factors for prostate cancer detection (patient’s age, serum PSA level, digital rectal exam (DRE), histopathological<br> findings on the previous cancer- negative biopsy and the epigenetic assay), Confirm mdx was shown to be the most significant, independent<br> predictor for prostate cancer in a repeat biopsy with an odds ratio of 3.24 (and a p-value < 0.001). An additional clinical validity<br> study published in 2017 demonstrated that the Confirm mdx test improved the identification of African American men at risk for aggressive<br> cancer missed by a prostate biopsy, with accuracy equivalent to prior studies in predominantly Caucasian populations.
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●	Clinical utility. A 2014 study reported on the real-world use of the Confirm mdx assay, demonstrating that the test impacts physician<br> behavior. A very low rate of repeat biopsies (4.4%) was observed in the Confirm mdx negative men, as compared to the expected 43%<br> rate of repeat biopsy reported in a large population-based randomized trial sponsored by the National Cancer Institute.
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●	Health economic outcomes. In a study published in 2013, a budget impact model developed to evaluate the effect of the Confirm mdx<br> assay on healthcare spending demonstrated significant potential healthcare savings associated with the reduction of repeat biopsies<br> and complications avoided. Under the study’s model, utilization of Confirm mdx would bring approximately $500,000 in annual<br> savings per 1 million covered patients.
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GPS Tissue Test

Currently, most cases of detected prostate cancer remain indolent and men with the disease often die from other causes. Patients who have indolent prostate cancer may be appropriately managed with observation or AS, while those with aggressive cancers may benefit from immediate treatment. The use of AS has increased in recent years and it is now estimated that up to 50% of clinically low-risk patients choose AS, while the remainder choose some type of immediate treatment.

The tissue-based GPS test assesses 17 genes in total — 12 cancer-related genes representing 4 important biologic pathways (androgen signaling, cellular organization, stromal response, and proliferation) together with 5 references genes (to control for RNA quantity and quality). The test uses reverse transcription polymerase chain reaction (“RT-PCR”) to measure gene expression in very small amounts of prostate tumor tissue (requiring as little as 5 ng of RNA). Genetic expression of the 12 cancer-related genes, normalized by the 5 reference genes, is used in an algorithm to generate a GPS result that ranges from 0 to 100, with higher scores associated with more aggressive disease. The GPS test, in conjunction with clinical risk factors, is predictive of a finding of adverse pathology (“AP”) upon a radical prostatectomy (“RP”) and clinical recurrence following RP, and consequently provides clinicians and patients with information about the likely aggressiveness of their cancer to help guide initial treatment decisions.

For patients with NCCN very low- to favorable intermediate- prostate cancer, the GPS test provides information on the risk of AP to help physicians guide personalized treatment for patients at the initial decision point. For the unfavorable intermediate- and high-risk groups, the GPS test helps inform decisions on the intensity of definitive treatment. The patient results report gives the risk of a patient developing metastasis within 10 years, risk of PCD within 10 years, and risk of tumor aggressiveness based on AP result outlining the clinical characteristics of each NCCN risk group.

The GPS test is intended for men with clinically localized prostate cancer who have undergone biopsy within 3 years and have not yet started treatment. Patients with any NCCN risk category between very low- and high-risk are eligible for GPS testing.

Guidelines Inclusion

GPS has been included in the NCCN Prostate Cancer guidelines since 2019.

Clinical ValidationStudies

The use of GPS as a predictive test to identify men at low risk for aggressive prostate cancer has been well validated in both scientific and clinical studies.

The following is a summary that highlights key findings from clinical studies regarding the GPS test.

●	Clinical validity. In a prospective and retrospective<br>study on 402 patients published in 2015, the GPS test demonstrated its ability to discriminate prostate cancer aggressiveness in biopsy<br>tissue despite tumor heterogeneity and multifocality. Further, the test demonstrated its ability to improve prediction of adverse pathology.
●	Clinical utility. Numerous clinical studies have shown<br>the impact of GPS on treatment recommendations and have demonstrated that generally, use of GPS increases the proportion of men for whom<br>AS is recommended, when the background AS rates are similar to the national average for these risk groups.
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o	In a prospective decision impact study by Badani et al. (2015)<br>of 158 patients with NCCN very low-, low- and low intermediate-risk disease, the GPS test resulted in a 26% change in recommended treatment<br>modality or intensity and patients who received GPS testing had a 24% relative increase in AS recommendations.
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o	In a chart review study by Dall’Era et al. (2015) of<br>211 patients with NCCN very low- or low risk-disease, biological risk predicted by GPS differed from NCCN clinical risk alone in 62 men<br>(39%). AS use increased by 24% in patients who received the GPS test versus patients who did not receive the GPS test.
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o	In a study by Eure et al. (2017)<br>of 297 patients, 23% of patients’ risk was restratified. In the NCCN low-risk group, the change in the management plan between<br>AS and immediate treatment was 28%; 51% of the men who were initially recommended immediate treatment pre-GPS testing switched to AS<br>post-GPS testing, while 14% of those initially recommended AS switched to immediate treatment post-GPS testing. Among the men who elected<br>AS, their one-year AS persistence rates remained high at 89%.A fourth study by Lynch et al. (2017) demonstrated utility in a US Department<br>of Veterans Affairs population, an equal-access healthcare system with high baseline AS rates without testing.<br>The study compared management patterns for men with NCCN very low-, low-, and intermediate-risk PCa with and without molecular profiling.<br>Overall, use of AS was 12% higher (absolute; relative increase 19%) in GPS-tested versus untested men, with the biggest increases observed<br>in low-risk patients (90% versus 72% for tested versus untested, respectively) and patients under the age of 60 (75% versus 42% for tested<br>versus untested, respectively).
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●	Health economic outcomes. A 2016 publication in Reviews<br>in Urology presented a comprehensive economic analysis of the GPS test in low-risk prostate cancer patients. Results showed that use<br>of the GPS test results in a net savings of $2,286 USD per patient — including the cost of the test — by decreasing unnecessary<br>immediate invasive treatments. The study demonstrated that incorporation of the GPS test as part of the treatment decision algorithm<br>for patients with NCCN very low- and low-risk disease (64% of the study population) led to a 21% net increase in the use of AS. Of these,<br>treatment patterns and cost for 80 men tested with GPS were compared to 100 patients in the same practice without genomic testing. Based<br>on a real-world practice setting in the U.S. Northeast with a contemporary patient population and using current treatment cost averages,<br>these results demonstrated that the use of the GPS test represented a reduction in cost of unnecessary intermediate interventions (by<br>more than 50%) over a 6-month period. Additional savings can also be expected by removing the cost of management of associated side effects<br>of treatment such as impotence and incontinence.
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Resolve mdx for Urinary Tract Infection

UTIs affect around 10 million people who seek medical attention every year. It is estimated that 2-3 million of these cases lead to emergency department visits. UTIs can be complicated and recurrent, resulting in painful symptoms such as abdominal and rectal pain, frequent urination, burning or pain during urination, and fatigue. Antibiotic resistance is a significant issue, observed in up to one-third of UTI infections, causing about 2.8 million infections and 35,000 deaths annually, according to the CDC.

The traditional method of conducting a UTI test, urine culture, can take up to 3 to 5 days to produce results. Unfortunately, relying solely on culture-based testing may produce equivocal results of “mixed flora” in up to 30% of cases, Often clinicians will rely on empiric therapy to treat UTIs, which can lead to overuse/misuse of antibiotics. Through the use of Resolve mdx, we help support antibiotic stewardship initiatives, as our test identifies personalized antibiotic options that would be expected to be more effective against the patient’s infection.

To address this unmet clinical need, with Resolve mdx we developed an advanced urine test that utilizes Polymerase Chain Reaction (“PCR”) technology to detect and quantify both infectious pathogens and resistance genes. Resolve mdx also includes susceptibility testing to identify the antibiotics that may be best suited to resolve the urinary tract infection. This approach provides prompt and accurate pathogen identification and personalized antibiotic recommendations. PCR-based testing offers improved sensitivity and specificity in identifying pathogens, addressing the problem of “mixed flora” results associated with traditional testing methods. This increased accuracy provides physicians with clinically actionable information to guide their decision-making for patient care.

Our proprietary Antibiotic Susceptibility Testing method included with the Resolve mdx test, called ASTX, determines how each pathogen responds to the 26 antibiotics tested. The unique aspect of ASTX is that it tests whole urine samples, ensuring accurate results and identifying the most effective treatment options for patients.

Resolve mdx Pathogens Tested,Resistance Genes and Antibiotics

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Our goal is to help pinpoint not only the offending organisms, regardless of how many are identified, but also the most likely oral antibiotics capable of clearing the entire infection. We estimate the addressable market in the United States for UTI testing at approximately 2 million cases annually, or $1 billion.

Pipeline

We intend to build on our leadership in the urologic diagnostic space by expanding our menu of tests beyond Select mdx, Confirm mdx, GPS and Resolve mdx. We are currently developing an additional product for the prostate cancer diagnostic and treatment pathway. AS is a management approach for prostate cancer that involves closely monitoring the cancer’s progression through regular tests and imaging, without immediately initiating active treatment such as surgery or radiation therapy. Since not all prostate cancers progress the same manner, there is a significant unmet clinical need to help physicians identify which patients may benefit from AS, distinguishing those at risk for disease progression.

Men on AS are monitored using PSA, MRI and periodic biopsies to determine if their prostate cancer has progressed and whether definitive treatment is necessary. We are actively analyzing urine and blood biomarker panels with the goal of developing a non-invasive test for monitoring these patients that we call Monitor mdx. A testing solution that allows a physician to forego or delay their patient’s surveillance biopsy would represent a significant business opportunity with little or no direct competition.

If our development efforts are successful, MDxHealth would have a full offering of biomarker-based prostate cancer tests from early detection to treatment and management. Select mdx and Confirm mdx help determine which patients should (or should not) undergo a prostate biopsy, while our GPS test guides the decision to enter into AS upon an initial diagnosis of prostate cancer. In the AS setting, Monitor mdx would provide methods to identify and monitor patients who could remain on AS as a treatment option.

Laboratory Operations

We currently process tests at our 38,000 square foot, CAP-accredited, CLIA-certified, and NYSDOH-approved molecular laboratory and office facility located at our U.S. headquarters in Irvine, California; through our 7,800 square foot diagnostic facilities in Nijmegen, The Netherlands; and through our smaller, CAP-accredited, CLIA-certified laboratory facility in Plano, Texas. Our GPS test is currently performed by Exact Sciences in its laboratory facility in Redwood City, California. Our current clinical reference laboratory has excess processing expansion capacity with incremental increases in laboratory personnel and equipment, including expansion capacity for laboratory facilities. We believe that we currently have sufficient capacity to process all of our tests. We may require additional facilities in the future as we expand our business and believe that additional space, when needed, will be available on commercially reasonable terms.

Sales and Marketing

Our sales approach focuses on the clinical and economic benefits of our tests as supported by peer-reviewed literature covering the clinical validation and utility of these tests. Our sales and marketing team include molecular diagnostic specialists, reimbursement account managers, clinical liaisons and client service personnel. Sales personnel are primarily field based, client service and marketing personnel are primarily based in our California headquarters.

Our sales team is trained to address the clinical, economic and reimbursement questions associated with selling our tests. Our sales force focuses on educating its primary and secondary clientele, which consists of urologists and their clinical staff, including nurses, laboratory and pathology personnel, finance administrators and billing personnel, and secondarily the pathology and laboratory staff who fulfil test requests on behalf of their clinician clients. Our current urology sales force consists of direct sales representatives, strategic account managers and regional sales managers.

Our sales efforts are directed towards increasing adoption and utilization of our tests in clinical practice. The strategy entails:

●	working<br>with community-based, large group practices and academic urologists to educate them on the clinical and economic benefits provided by<br>our tests;
●	nurturing<br>and strengthening relationships with key thought leaders in urology;
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●	supporting<br>ongoing collaborations with leading universities and research institutions that have generated clinical validation data supporting our<br>tests; and
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●	encouraging<br>ongoing exploration and studies of expanded indications for our tests.
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Successful penetration of the urology market and clinical adoption of our tests has been achieved with a multi-faceted approach to build brand recognition and raise awareness of the tests. Our efforts and programs include sharing information with leaders in the medical community on a national and regional scale, supporting clinical studies for the publication of peer reviewed journals and abstracts at key scientific conferences, development of tools for our customers to interact with patients and consumers (doctor-to-consumer education), providing support to patient advocacy groups like Prostate Conditions Education Council, developing strategic partnerships with leading pathology laboratories with large urology client bases, participation in industry trade shows and the implementation of public relations, media and advertising campaigns.

Reimbursement

Reimbursement of our tests by third-party payors is essential to our commercial success. Payment for our testing services may come from, in some cases:

●	third-party payors<br>that provide health care coverage to the patient (e.g., commercial health insurance companies or managed care organizations);
●	federal<br>health care programs, such as Medicare, state Medicaid programs, the Department of Defense and Veterans Affairs hospitals in the United States;
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●	other<br>government agencies or laboratories that order the testing service; and
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●	patients<br>in cases where the patient has no insurance or coverage benefit, is underinsured or has insurance with cost sharing benefits whereby<br>the insurance covers a percentage of testing costs, and the patients are responsible for a co-payment, co-insurance and/or deductible<br>amount.
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Reimbursement for diagnostic tests furnished to Medicare beneficiaries (typically patients aged 65 or older) is typically based on a fee schedule set by CMS, a division of the HHS.

In 2014, 2015 and 2023, respectively, our Confirm mdx test, our GPS test and our Select mdx test received positive Medicare LCDs under the MoIDX Program, which provide coverage and reimbursement for Medicare beneficiaries throughout the United States. Our Resolve mdx UTI test is currently reimbursed by Medicare and most private insurance payors, based on nationally recognized CPT codes.

We believe the clinical utility and actionability of our tests, combined with our experience and knowledge of the complex coverage and reimbursement landscape in the United States will enable us to expand coverage and reimbursement of our tests among the commercial payor market. We continue to build upon our successful strategy, using our Medicare LCD for Confirm mdx, Select mdx and GPS and existing commercial payor contracts as a foundation to secure additional contracts from major payors.

Where there is a payor policy or contract in place, we bill in accordance with the terms of that policy or contract. Where there is no payor policy or contract in place, we pursue third-party reimbursement on behalf of each patient on a case-by-case basis. Our efforts on behalf of these patients involve a substantial amount of time and expense, and bills may not be paid for many months, if at all. Furthermore, if a third-party payor denies coverage after final appeal, it may take a substantial amount of time to collect from the patient, if we are able to collect at all.

Materials Needed for Our Laboratory Services

In connection with our role as a CLIA-certified provider of laboratory services, we assist healthcare providers with certain logistics related to the collection and return of samples for testing.

The processing of testing solutions requires items and services, the majority of which are sourced from multiple suppliers. Certain of the consumable supplies and reagents used in our testing process are procured from a limited number of suppliers, some of which are single source. In addition, we rely on a limited number of suppliers, or in some cases a single supplier (for example, for the automation of our deparaffination steps for the Confirm mdx test), for certain equipment with which we perform testing services. To date, we have acquired all of our equipment and the majority of our materials on a purchase order basis, and we generally do not have language included in contracts with our suppliers and manufacturers that commit them to supply equipment and materials to us.

Competition

The molecular diagnostics field is characterized by rapid technological changes, frequent new product introductions, changing customer preferences, emerging competition, evolving industry standards, reimbursement uncertainty and price competition. Moreover, the molecular diagnostics field is intensely competitive both in terms of service and price, and continues to undergo significant consolidation, permitting larger clinical laboratory service providers to increase cost efficiencies and service levels, resulting in more intense competition.

The market for assessing men at risk for prostate cancer is large. As a result, this market has attracted competitors, some of which possess substantially greater financial, selling, logistical and laboratory resources, more experience in dealing with third-party payors, and greater market penetration, purchasing power and marketing budgets, as well as more experience in providing diagnostic services. Some companies and institutions are developing liquid biopsy (blood and urine)-based tests and diagnostic tests based on the detection of proteins, mRNA, nucleic acids or the presence of fragments of mutated genes that are associated with prostate cancer. These competitors could have technological, financial, reputational, and market access advantages over us.

In regard to our Select mdx for Prostate Cancer test, several directly competitive products are currently commercially available. In 2014, OPKO Health, a NYSE listed company, launched the 4Kscore test, a blood based 4-plex test which combines the results of the blood test with clinical information in an algorithm that calculates a patient’s percent risk for aggressive prostate cancer prior to an initial or repeat biopsy (no previous diagnosis of prostate cancer). The 4Kscore test received marketing approval from the FDA in December 2021. OPKO Health, a NYSE listed company, operates one of the largest clinical laboratories in the United States. The 4Kscore test competes directly with Select mdx. In 2016, ExosomeDx launched the ExoDx (Intelliscore), a urine-based test designed to assess whether patient presenting for an initial or repeat biopsy is at greater risk for high-grade prostate cancer. The ExoDx test competes directly with Select mdx. In 2018, Bio-Techne Corporation, a large U.S.-based, diversified life sciences company, acquired the ExoDx test. In addition to the ExoDx and the 4Kscore tests, the Prostate Health Index test (“phi score”) offered by Beckman Coulter, competes directly with the Select mdx test. In addition, each of these tests may also provide a competitive advantage since, unlike the Select mdx test, they do not require a digital rectal procedure as part of their specimen collection process. Each of Bio-Techne, OPKO Health and Beckman Coulter have greater resources and significantly larger sales and marketing teams than MDxHealth. As a result of these significantly greater resources, these competitors are able to make larger investments into the tests they produce and the sales and marketing of these tests, which may cause us to lose market share.

In regard to our Confirm mdx for Prostate Cancer test, several competitive products are currently commercially available. Both the 4Kscore test, offered by OPKO Health, and the ExoDx (Intelliscore) test offered by ExosomeDx, compete with the Confirm mdx test. Offered at a lower price point, both the 4Kscore and ExoDx tests offer a competitive price advantage over the Confirm mdx test. In addition, both the 4Kscore test and the PCA-3 test from Hologic, a urine-based test, are on the U.S. market as FDA-approved tests, which may be perceived as providing a competitive advantage since the Confirm mdx for Prostate Cancer test is not FDA approved. The PCA-3 test is intended for the same patient population as Confirm mdx for Prostate Cancer, but its performance has only been established in men who were already recommended by urologists for repeat biopsy.

In addition to competitive products, the Confirm mdx, Select mdx and GPS tests also face competition from mpMRI, a clinical diagnostic imaging procedure available to and used by physicians for many years, which focuses on visual tissue analysis. The mpMRI procedure can visually reveal potential locations of abnormal and potentially cancerous prostate tissue characteristics that distinguish tumors from healthy tissue. The visual aspect of diagnostic imaging may feel more accessible and be considered preferable by some physicians over molecular analysis, and there likely is an economic incentive for some physicians to earn a professional fee from the performance of mpMRI procedures. It may be difficult to change the methods or behavior of physicians to incorporate our testing solutions into their practices in conjunction with, or instead of, mpMRI clinical diagnostic imaging procedures. In addition, companies developing or offering capital equipment or point-of-care kits to physicians represent another source of potential competition. These devices are used directly by the physicians or their institutions, which can facilitate adoption.

Intellectual Property

Our intellectual property and its protection are crucial to the operation of our business. We are committed to developing and protecting our intellectual property and, where appropriate, filing patent applications or securing licenses to patents to protect our technology. We rely on a combination of patent, copyright, trademark and other agreements with employees and third parties to establish and protect our proprietary intellectual property rights. We also rely upon trade secret laws to protect unpatented know-how and continuing technological innovation. However, trade secrets can be difficult to protect, and do not provide protection against a third party independently discovering or recreating the information for which trade secret protection is claimed. We seek to protect our proprietary unpatented technology, know how, algorithms and processes, in part, by entering into confidentiality agreements with our employees, consultants, scientific advisors and contractors and limit access to, and distribution of, our proprietary information. We also require our officers, employees and consultants to enter into standard agreements containing provisions requiring confidentiality of proprietary information and assignment to us of all inventions made during the course of their employment or consulting relationship. We also enter into nondisclosure agreements with our commercial counterparties and limit access to, and distribution of, our proprietary information. We also seek to preserve the integrity and confidentiality of our data and trade secrets by maintaining physical security of our premises and physical and electronic security of our information technology systems.

We believe that our patent portfolio places us in a competitive position in the realm of molecular cancer diagnostics. We own or hold exclusive rights to a range of issued and pending patents in multiple countries worldwide covering our epigenetic and molecular tests and associated biomarkers, their methods of use and any other inventions that are important to the development of our business. Many of our commercially important technology and inventions are in-licensed from academic and commercial collaborators. Through our internal R&D programs, together with our academic and commercial collaborations, we continue to be at the forefront of researching and understanding the link between cancer and methylation (epigenetics), and how this link can be translated into meaningful clinical molecular diagnostic products and services. We consider patent protection of the technologies, on which our products are based, to be a key factor to our success.

Our intellectual property portfolio is managed by an in-house intellectual property team, which works in close collaboration with qualified external patent attorneys both in Europe and the United States. As of December 31, 2022, we own or have exclusive rights to more than 17 patent families related to our molecular technology and cancer-specific biomarkers. Specifically, there are 116 granted or pending patent applications in this group comprised of 16 issued or allowed U.S. patents, 7 pending U.S. provisional or non-provisional applications, 19 pending international patent applications filed under the PCT and 74 granted or allowed patents in jurisdictions outside the United States, including Japan, Canada, Israel and certain European countries. Our issued U.S. patents expire at various times between 2024 and 2038. Of these issued patents, 1 covers intellectual property used in our Confirm mdx test, which expires in 2024, 7 cover intellectual property used in our Select mdx test, the last of which expires in 2036, and 52 cover intellectual property used in our GPS test, the last of which expires in 2038. When these patents expire other companies will no longer be prohibited from incorporating the subject intellectual property into competing tests they may seek to develop. Nevertheless, given the significant unpatented proprietary and confidential intellectual property that we have developed and that is used in our tests, together with the clinical performance characteristics reported in published clinical studies that are specific to these branded tests, we believe there will be significant barriers to any competitors’ ability to use such previously patent-protected intellectual property to develop competitive tests.

In most countries in which we file, our patents have a life of 20 years from the date of the filing of the nonprovisional application. In the United States, a patent’s term may be lengthened by patent term adjustment, which compensates a patentee for administrative delays by the USPTO in granting a patent, or may be shortened if a patent is terminally disclaimed over an earlier-expiring patent. The expected expiration dates listed above assume that no terminal disclaimers will be filed. A patent term can also be lengthened in certain countries, including the United States, under circumstances where there is a delay associated with approval from a governmental regulatory agency.

We may in the future receive notices of claims of infringement and misappropriation or misuse of other parties’ proprietary rights and may from time to time receive additional notices. Assertions of misappropriation, infringement or misuse, or actions seeking to establish the validity of our patents could materially or adversely affect our business, financial condition and results of operations.

Collaboration and License Agreements

Collaborative research agreements and clinicalresearch agreements

We have entered into agreements with universities, medical centers and external researchers for research and development work and for the validation of our technology and products. These agreements typically have durations of one to three years. In certain circumstances, we pay fixed fees to the collaborators and in exchange typically receive access and rights to the results of the work. MDxHealth has collaborated on research and clinical development with a number of the world’s leading academic and government cancer research institutes. These important relationships have provided us with additional resources and expertise for clinical marker validation as well as access to patient samples for testing.

Commercial and intellectual property licensingagreements

We have entered into numerous agreements with universities and companies for in-licensing intellectual property. These agreements typically require us to pay an up-front fee, annual maintenance fees and/or minimum annual royalty fees, legal fees related to the patents, and certain milestone and royalty fees if the patents are eventually used in a commercialized product. In addition, we must provide the licensor with periodic reports.

In particular, we are party to an Amended and Restated Exclusive License Agreement with The Johns Hopkins University through which we hold an exclusive license to intellectual property that is used in our Confirm mdx test. Pursuant to this agreement, we made upfront license fee payments of $10,000 in each of 2004 and 2005, and we are obligated to pay a mid-single-digit royalty rate on our net sales of Confirm mdx (with minimum annual royalties of $5,000). Unless earlier terminated in accordance with the agreement, the agreement will remain in effect until the last of the licensed patents expires in 2024. The agreement contains customary termination provisions which, among other things, permit termination in the event of material uncured breaches.

In regard to our developed tests, we have entered into a range of marketing and sales arrangements with commercial entities. These important relationships provide us with additional resources and infrastructure to expand the geographic reach and awareness of our solutions. Our marketing partners include Ferrer Internacional, SouthGenetics, LifeLabs, Helix Laboratories, Laboratory Corporation of America (LabCorp), Inform Diagnostics (InformDx) and Poplar Healthcare.

Government Regulations

Certain of our activities are subject to regulatory oversight by CMS pursuant to CLIA, as well as agencies in various states, including New York. We are subject to many other federal, state and foreign laws, including anti-fraud and abuse, anti-kickback and patient privacy. Failure to comply with applicable requirements can lead to sanctions, including withdrawal of products from the market, recalls, refusal to authorize government contracts, product seizures, exclusion from participation in federal and state healthcare programs, civil money penalties, injunctions, and criminal prosecution.

Laboratory Certification, Accreditation,and Licensing

We are also subject to U.S. and state laws and regulations regarding the operation of clinical laboratories. CLIA requirements and laws of certain states, including those of California, New York, Maryland, Pennsylvania and Rhode Island, impose certification requirements for clinical laboratories, and establish standards for quality assurance and quality control, among other things. CLIA provides that a state may adopt different or more stringent regulations than federal law and permits states to apply for exemption from CLIA if the state’s laboratory laws are equivalent to or more stringent than CLIA. For example, the State of New York’s clinical laboratory regulations, which have received an exemption from CLIA, contain provisions that are in certain respects more stringent than federal law. Therefore, as long as New York maintains a licensure program that is CLIA-exempt, we will need to comply with New York’s clinical laboratory regulations in order to offer our clinical laboratory products and services in New York.

Our U.S. laboratory facilities in Irvine, California and Plano, Texas are certified under CLIA. Clinical laboratories are subject to inspection by regulators and to sanctions for failing to comply with applicable requirements. Sanctions available under CLIA and certain state laws include prohibiting a laboratory from running tests, requiring a laboratory to implement a corrective plan, and imposing civil monetary penalties. If we fail to meet any applicable requirements of CLIA or state law, that failure could adversely affect any future CMS consideration of our technologies, prevent their approval entirely, and/or interrupt the commercial sale of any products and services and otherwise cause us to incur significant expense.

HIPAA and Other Privacy Laws

The Health Insurance Portability and Accountability Act of 1996, as amended by HIPAA established comprehensive protection for the privacy and security of health information. The HIPAA standards apply to three types of organizations, or “Covered Entities”: (1) health plans, (2) healthcare clearinghouses, and (3) healthcare providers that conduct certain healthcare transactions electronically. Covered Entities and their business associates must have in place administrative, physical, and technical standards to guard against the misuse of individually identifiable health information. As a clinical laboratory that engages in HIPAA-covered standard transactions, we are a Covered Entity subject to regulation under HIPAA. We have implemented privacy and security policies and procedures, provided required training to our personnel, and ensure that we enter into Business Associate Agreements with our vendors who have access to our protected health information. Penalties for violations of HIPAA include civil money and criminal penalties.

HIPAA establishes a federal “floor” with respect to privacy, security, and breach notification requirements and does not supersede any state laws insofar as they are broader or more stringent than HIPAA. Numerous state and certain other federal laws protect the confidentiality of health information and other personal information, including but not limited to state medical privacy laws, state laws protecting personal information, state data breach notification laws, state genetic privacy laws, human subjects research laws and federal and state consumer protection laws. These additional federal and state privacy and security-related laws may be more restrictive than HIPAA and could impose additional penalties. For example, the Federal Trade Commission uses its consumer protection authority under Section 5 of the Federal Trade Act to initiate enforcement actions in response to alleged privacy violations and data breaches. California recently enacted the California Consumer Privacy Act (“CCPA”), which went into effect on January 1, 2020. The CCPA, among other things, creates new data privacy obligations for covered companies and provides new privacy rights to California residents, including the right to opt out of certain disclosures of their information. The CCPA also creates a private right of action with statutory damages for certain data breaches, thereby potentially increasing risks associated with a data breach. California recently amended and expanded the CCPA through another ballot initiative, the California Privacy Rights Act (“CPRA”), passed on November 3, 2020. It remains unclear what, if any, additional modifications will be made to the CPRA by the California legislature or how it will be interpreted. In addition to California, other states have strengthened their data security laws and others are indicated their intention to do so as well. Virginia also enacted a comprehensive data privacy and security law, the Virginia Consumer Data Protection Act, on March 2, 2021, to go into effect on January 1, 2023. We expect that other states will follow with their own comprehensive data privacy legislation as well. Our activities must therefore comply with these other applicable privacy laws, which impose further restrictions on the access, use and disclosure of personal information. Further, we are required to comply with international personal data protection laws and regulations, including the European Union’s General Data Protection Regulation (“GDPR”). The GDPR is a prescriptive, detailed regulation that provides extensive powers to public authorities to sanction and stop use of personal data. While companies are afforded some flexibility in determining how to comply with the GDPR’s various requirements, the GDPR has and will continue to require significant effort and expense to ensure compliance. All of these laws may impact our business and may change periodically, which could adversely affect our business operations. Our failure to comply with these privacy laws or significant changes in the laws restricting our ability to obtain stool, tissue, blood, and other patient samples and associated patient information could significantly impact our business and our future business plans, including potentially a temporary inability to provide tests to patients in the European Union.

In Vitro Regulation

Under current law, in vitro diagnostics that the FDA regulates as medical devices must undergo premarket review prior to commercialization, unless the device is exempt from such review. The particular premarket requirements that must be met to market a medical device in the United States will depend on the classification of the device under FDA regulations. Medical devices are categorized into one of three classes, based on the degree of risk they present. Devices that pose the lowest risk are designated as Class I devices; devices that pose moderate risk are designated as Class II devices and are subject to general controls and special controls; and the devices that pose the highest risk are designated as Class III devices and are subject to general controls and premarket approval. As a CLIA-certified laboratory, we offer our Select mdx and Confirm mdx testing services as LDTs, and we may seek to commercialize future testing services in development as LDTs. LDTs are generally defined as clinical laboratory tests that are developed and validated by a laboratory for its own use. Historically, the FDA has exercised enforcement discretion and not required approvals or clearances for many LDTs (as that term is viewed and defined by the FDA, which is the subject of interpretation) that are regulated under CLIA, and has not required laboratories that offer LDTs consistent with FDA’s interpretation to comply with the FDA requirements for medical devices, such as registration, device listing, quality systems regulations, premarket clearance or premarket approval, and post-market controls.

Regulatory jurisdiction over LDTs has historically been greatly disputed. For many years, the FDA has expressed its position through a range of guidance documents and precedent provided through enforcement action. The FDA has issued documents outlining its intent, at various times, to require varying levels of heightened FDA oversight of many laboratory tests that have traditionally been offered as LDTs, including categories that would include our tests. Additionally, in recent years, Congress has introduced two draft bills: the VALID Act and the VITAL Act of 2021. While we cannot predict whether the either VALID Act or the VITAL Act as proposed, or any modified version of either act will be enacted into law, it is expected that some form of the acts will be incorporated into a broader health care legislative package. It is unknown at this time whether legislation will be enacted impacting LDTs, or whether in the interim the FDA may take a more aggressive enforcement approach toward certain laboratory testing. Legal, regulatory, and policy developments may materially impact our ability to develop and commercialize testing services as LDTs, including without limitation our current tests.

Until regulatory requirements suggested by the FDA or required by any new legislation are phased in, we do not consider our current LDTs to require FDA filings or clearance or approval before launch and we will continue to follow the CLIA certification and inspection pathway.

If the new requirements are phased in or if we elect to develop IVDs, our future offerings may require a 510(k) submission or a Premarket Approval (“PMA”) application to the FDA. In a 510(k) submission, the device sponsor must demonstrate that the new device is “substantially equivalent” to a predicate device in terms of intended use, technological characteristics, and performance testing. A 510(k) requires demonstration of substantial equivalence to another device that is legally marketed in the United States. Substantial equivalence means that the new device is at least as safe and effective as the predicate. A device is substantially equivalent if, in comparison to a predicate it (a) has the same intended use as the predicate and has the same technological characteristics as the predicate; or (b) has the same intended use as the predicate, has different technological characteristics, and the information submitted to the FDA does not raise new questions of safety and effectiveness, and is demonstrated to be at least as safe and effective as the legally marketed predicate device.

A claim of substantial equivalence does not mean the new and predicate devices must be identical. Substantial equivalence is established with respect to intended use, design, energy used or delivered, materials, chemical composition, manufacturing process, performance, safety, effectiveness, labeling, biocompatibility, standards, and other characteristics. A device may not be marketed in the United States until the submitter receives a letter declaring the device substantially equivalent. If the FDA determines that a device is not substantially equivalent, the applicant may resubmit another 510(k) with new data, or request a Class I or II designation through the FDA’s de novo process that allows a new device without a valid predicate to be classified into Class I or II if it meets certain criteria, or file a reclassification petition, or submit a PMA.

Manufacturers of medical devices must comply with various regulatory requirements under the FDCA and regulations thereunder, including, but not limited to, quality system regulations, unless they are exempt, facility registration, product listing, labeling requirements, and certain post-market surveillance requirements. Entities that fail to comply with FDA requirements can be liable for criminal or civil penalties, such as recalls, detentions, orders to cease manufacturing, and restrictions on labeling and promotion, among other potential sanctions.

The regulatory review and approval process for medical devices can be costly, timely, and uncertain. This process may involve, among other things, successfully completing additional clinical trials and submitting a premarket clearance notice or filing a premarket approval application with the FDA. If premarket review is required by the FDA, there can be no assurance that our tests will be cleared or approved on a timely basis, if at all. In addition, there can be no assurance that the labeling claims cleared or approved by the FDA will be consistent with our current claims or adequate to support continued adoption of and reimbursement for our products. Ongoing compliance with FDA regulations could increase the cost of conducting our business, subject us to FDA inspections and other regulatory actions, and potentially subject us to penalties in the event we fail to comply with such requirements.

Federal and State Fraud and Abuse Laws

False Claims and Overpayments

We are subject to numerous federal and state fraud and abuse laws, including the federal False Claims Act. Many of these fraud and abuse laws are broad in scope, and, at least with respect to the state laws, neither the courts nor relevant government agencies have extensively interpreted these laws. Prohibitions under some of these laws include:

●	the submission<br> of false claims or false information to government programs,
●	the retention<br> of any overpayments received from governmental payors,
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●	deceptive<br> or fraudulent conduct,
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●	excessive<br> or unnecessary services or services at excessive prices, and
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●	defrauding<br> commercial health insurers.
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We may be subject to substantial penalties for violations of these fraud and abuse laws, including denial of payment and refunds or recoupments, suspension of payments from Medicare, Medicaid or other federal health care programs, and exclusion from participation in federal and state health care programs, as well as civil monetary and criminal penalties and imprisonment. Numerous federal and state agencies enforce the fraud and abuse laws. In addition, commercial insurers may also bring private actions. In some circumstances, private whistleblowers are authorized to bring lawsuits on behalf of the government against providers and are entitled to receive a portion of any final recovery.

In addition, amendments to the FCA impose severe penalties for the knowing and improper retention of overpayments collected from governmental payors. Within sixty days of identifying and quantifying an overpayment, a provider is required to notify CMS or the relevant MAC of the overpayment (and the reason for it) and to return the overpayment; failure to do so may result in a separate basis for liability under the FCA. These amendments could subject our procedures for identifying and processing payments to greater scrutiny. Overpayments may occur from time to time in the healthcare industry without any fraudulent intent. For example, overpayments may result from mistakes in reimbursement claim forms or from improper processing by governmental payors. We maintain protocols intended to identify any overpayments and to make timely refunds as appropriate. From time to time, we have identified overpayments and made appropriate refunds to government payors.

To avoid liability, we must carefully and accurately code claims for reimbursement, proactively monitor the accuracy and appropriateness of Medicare claims and payments received, diligently investigate any credible information indicating that we may have received an overpayment, and promptly return any overpayments.

Federal and State “Self-Referral”and “Anti-Kickback” Restrictions

If we or our operations are found to be in violation of applicable laws and regulations prohibiting improper referrals for healthcare items or services, we may be subject to penalties, including civil and criminal penalties, damages, fines, exclusion from participation in U.S. federal or state healthcare programs, and the curtailment or restructuring of our operations.

Anti-Kickback Statute

The federal Anti-Kickback Statute prohibits persons from knowingly and willfully soliciting, receiving, offering, or paying remuneration, directly or indirectly, to induce either the referral of an individual, or the furnishing, recommending, or arranging for an item or service, for which payment may be made under a federal health care program, such as the Medicare and Medicaid programs, unless an exception or “safe harbor” applies. The term “remuneration” is not defined in the federal Anti-Kickback Statute and has been broadly interpreted to include anything of value, including for example, gifts, discounts, the furnishing of supplies or equipment, credit arrangements, payments of cash, waivers of payment, ownership interests and providing anything at less than its fair market value. Sanctions for violations of the federal Anti-Kickback Statute may include imprisonment and other criminal penalties, civil monetary penalties, and exclusion from participation in federal health care programs. Further, the Affordable Care Act made clear that claims for items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil FCA. Further, the Affordable Care Act made clear that claims for items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil FCA. Many states have also adopted laws similar to the federal Anti-Kickback Statute, some of which are not limited in application to only items or services reimbursable by federal health care programs, and do not contain identical safe harbors.

In addition to the Anti-Kickback Statute, in October 2018, Congress enacted EKRA as a component of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act. EKRA is an anti-kickback law similar to the federal Anti-Kickback Statute that, subject to several exceptions, makes it a criminal offense to pay any remuneration to induce referrals to, or in exchange for, patients using the services of a recovery home, a substance use clinical treatment facility, or laboratory. Although it appears that EKRA was intended to reach patient brokering and similar arrangements to induce patronage of substance use recovery and treatment, the language in EKRA is broadly written and can apply to laboratory services covered under public or private payor arrangements. That said, an interpretation of EKRA that prohibits certain incentive compensation payments to sales employees or other forms of remuneration that would otherwise be permissible under a safe harbor to the federal Anti-Kickback Statute would directly conflict with the intent of the federal Anti-Kickback Statute and regulations and would prohibit a number of practices that are common throughout the industry. Significantly, EKRA permits the DOJ to issue regulations clarifying EKRA’s exceptions or adding additional exceptions, but no such regulations or applicable guidance have yet been issued.

Medicare Physician Self-ReferralLaw

The federal Physician Self-Referral Law, commonly referred to as the “Stark Law”, prohibits, subject to certain exceptions, physicians from making a referral to an entity for certain “designated health services” (“DHS”) payable by Medicare if the physician, or an immediate family member of the physician, has a direct or indirect financial relationship (including ownership interests and compensation arrangements) with the entity. The Stark Law also prohibits such an entity from presenting or causing to be presented a claim to Medicare for DHS provided pursuant to a prohibited referral, and provides that certain collections related to any such claims must be refunded in a timely manner. The Stark Law is a strict liability statute and therefore, any referrals for Medicare DHS pursuant to a financial relationship that does not meet an exception will be non-payable and subject to refund to Medicare. In addition, any Medicare “overpayment” (that is, Medicare funds to which a person is not entitled) must be returned within 60 days of identification — or risk liability under the FCA’s “obligation” provision. Therefore, claims relating to Stark Law violations must be timely refunded to Medicare or we would risk liability under the federal FCA. Violations of the Stark Law can also result in civil penalties and federal health care program exclusions for knowing violations and civil monetary assessments of up to three times the amount claimed. Although the Stark Law is drafted to apply only to Medicare claims, the DOJ has taken the position that it applies to Medicaid claims under an extension of the federal FCA and several courts, including courts in Florida and Texas, have agreed. In addition, there are comparable state laws, some of which apply to all payors (not just Medicare), and do not contain identical exceptions to the Stark Law.

Compliance with federal fraud and abuse laws such as the Anti-Kickback Statute and the Stark Law involve constant monitoring for regulatory changes, agency and court interpretations, and revisiting of arrangements based on new interpretations or clarifications, all of which will require ongoing compliance costs. In addition, these laws and their exceptions and safe harbors are complex and clear interpretations are not always available. Despite our best efforts to comply, we cannot guarantee that a government agency will necessarily agree with our interpretations or that one or more of our arrangements will not be subject to challenge, nor can we provide any assurance that they will not have an adverse effect on our business, financial condition, results of operations, and cash flows. Any action against us for violation of these or similar foreign laws, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management’s attention from the operation of our business.

Sunshine Act

In 2010, Congress enacted the Physician Payments Sunshine Act (“Sunshine Act”), which aims to promote transparency around financial relationships between physicians, teaching hospitals and certain life sciences industry manufacturers. The Sunshine Act requires manufacturers of drugs, devices, biologicals, and medical supplies covered by Medicare, Medicaid, or the Children’s Health Insurance Program to report annually to CMS any payments or other transfers of value made to healthcare providers and teaching hospitals, unless an exception applies. Manufacturers must also disclose to CMS any healthcare provider ownership or investment interests. Some states have similar transparency laws. Although we do not consider our laboratory services to be covered devices under the Sunshine Act, the laws and regulations are continually evolving and in the future we could be required to comply with transparency requirements in the future, or we could otherwise be subject to scrutiny for the nature and amount of our payments and transfers of value in the healthcare industry.

International

When marketing our tests outside of the United States, we are subject to foreign regulatory requirements governing human clinical testing, export of tissue, marketing approval for our products, and performance and reporting of tests in each market. These requirements vary by jurisdiction, differ from those in the United States, and may require us to perform additional pre-clinical or clinical testing. In many countries outside of the United States, coverage, pricing, and reimbursement approvals are also required in order for our tests to be made available to patients in substantial volume.

Many countries in which we offer our tests have anti-kickback regulations prohibiting providers, as well as medical and in vitro diagnostic device manufacturers, from offering, paying, soliciting, or receiving remuneration, directly or indirectly, or providing a benefit to a healthcare professional in order to induce business that is reimbursable under any national healthcare program. In situations involving healthcare providers employed by public or state-funded institutions or national healthcare services, violation of the local anti-corruption or anti-gift laws may also constitute a violation of the U.S. Foreign Corrupt Practices Act (“FCPA”).

The FCPA prohibits any U.S. individual, business entity, or employee of a U.S. business entity from offering or providing, directly or through a third party, including the distributors we rely on in certain markets, anything of value to a foreign government official with corrupt intent to influence an award or continuation of business or to gain an unfair advantage, whether or not such conduct violates local laws. In addition, it is illegal for a company that reports to the SEC to have false or inaccurate books or records or to fail to maintain a system of internal accounting controls. We are also required to maintain accurate information and control over sales and distributors’ activities that may fall within the purview of the FCPA, its books and records provisions, and its anti-bribery provisions.

Other Laws

Occupational Safety and Health

In addition to its comprehensive regulation of health and safety in the workplace in general, the Occupational Safety and Health Administration has established extensive requirements aimed specifically at laboratories and other healthcare-related facilities. In addition, because our operations require employees to use certain hazardous chemicals, we also must comply with regulations on hazard communication and hazardous chemicals in laboratories. These regulations require us, among other things, to develop written programs and plans, which must address methods for preventing and mitigating employee exposure, the use of personal protective equipment, and training.

Specimen Transportation

Our commercialization activities subject us to regulations of the Department of Transportation, the U.S. Postal Service, and the Centers for Disease Control and Prevention that apply to the surface and air transportation of clinical laboratory specimens.

C. Organizational Structure

MDxHealth SA is a company with limited liability (naamloze vennootschap/société anonyme) incorporated and operating under the laws of Belgium.

The following chart shows our organizational structure as of December 31, 2022:

Subsidiary Name	Jurisdiction of Organization	Ownership & Voting Interest Held by MDxHealth SA
MDxHealth,<br> Inc.	Delaware	100% (held directly)
MDxHealth<br> BV	The Netherlands	100% (held directly)
MDxHealth<br> Servicelab BV	The Netherlands	100% (held through MDxHealth<br> BV)
MDxHealth<br> Research BV	The Netherlands	100% (held through MDxHealth<br> BV)
Delta<br> Laboratories LLC	Texas	100% (held through MDxHealth,<br> Inc.)

D. Property, Plant and Equipment

We process our tests, and conduct research and development, at our 38,000 square foot U.S. headquarters and laboratory facility in Irvine, California pursuant to a lease that is currently scheduled to expire in 2026. This laboratory facility is certified pursuant to CLIA and accredited by CAP. We also maintain a small laboratory facility in Plano, Texas. This laboratory facility is certified pursuant to CLIA.

Our headquarters is located in the CAP Business Center, Herstal, Belgium.

We maintain offices and a laboratory facility located in Nijmegen, The Netherlands, where we process our Select mdx test and conduct research and development at our 7,800 square foot laboratory and office facility pursuant to a lease that is currently scheduled to expire in 2027.

We believe that our existing facilities are adequate for our near-term needs, and we believe that suitable additional or alternative office and manufacturing space will be available as required in the future on commercially reasonable terms.

ITEM 4A. UNRESOLVED STAFF COMMENTS

Not applicable.

ITEM 5. OPERATING AND FINANCIAL REVIEW ANDPROSPECTS

You should read the following discussion ofour operating and financial review and prospects in conjunction with our audited consolidated financial statements and the related notesthereto included elsewhere in this annual report. In addition to historical information, the following discussion and analysis containsforward-looking statements that reflect our current plans, estimates, expectations and beliefs and involve risks and uncertainties. Ouractual results and the timing of events could differ materially from those anticipated in the forward-looking statements as a resultof various factors. Factors that could cause or contribute to these differences include, but are not limited to, those discussed belowand elsewhere in this annual report, particularly in sections titled “Risk Factors” and “Special Note Regarding Forward-LookingStatements.”

Overview

We have experienced net losses and significant cash used in operating activities since inception in 2003. To date, our primary sources of capital have been public offerings of our ordinary shares and ADSs and private placements, debt financing agreements, and revenue from the sale of our products. Since inception, we have raised equity financing of approximately $360 million. As of December 31, 2022, we had cash and cash equivalents of $15.5 million, long-term loans and borrowings of $34.9 million and an accumulated deficit of $288.3 million. During the years ended December 31, 2020, 2021 and 2022, we generated revenue of $18.5 million, $22.2 million and $37.1 million, respectively, with a net loss of $28.7 million, $29.0 million and $44.0 million, respectively.

In February 2023, the Company raised $40 million in gross proceeds by means of a public offering of 10,000,000 ADSs being the equivalent of 100,000,000 new shares at an issue price of $4.00 per ADS (or approximately €0.37 per share) through a public offering. In March 2023, the Company received additional gross proceeds of $3.0 from the underwriters’ exercise of their overallotment option.

Management expects the Company to continue to incur net losses and have significant cash outflows for at least the next twelve months. While these conditions, among others, could raise doubt about our ability to continue as a going concern, these consolidated financial statements have been prepared assuming that the Company will continue as a going concern. This basis of accounting contemplates the recovery of our assets and the satisfaction of liabilities in the normal course of business. A successful transition to attaining profitable operations is dependent upon achieving a level of positive cash flows adequate to support the Company’s cost structure.

Acquisition of Genomic Prostate Score®(GPS) test (formerly Oncotype DX GPS) from Exact Sciences

On August 2, 2022, we announced that we have entered into an agreement with Genomic Health, Inc., a subsidiary of Exact Sciences, to acquire the GPS test from Exact Sciences. We acquired GPS in order to expand our menu of tests targeted into urology and prostate cancer and in order to position the Company as one of the leaders in the urology and prostate cancer space with one of the most comprehensive menus of precision diagnostics.

Under the terms of the agreement, we acquired the GPS prostate cancer business of Exact Sciences for an aggregate purchase price of up to $100 million, of which an amount of $25 million was paid in cash and an amount of $5 million was settled through the delivery of 691,171 ADSs of the Company, at a price per ADS of $7.23. Following the closing, which took place on August 2, 2022, an additional aggregate earn-out amount of up to $70 million is to be paid by us to Exact Sciences over a three year period, commencing in 2024, in tranches equal to a portion of the annual revenues attributable to the GPS prostate cancer business for the preceding fiscal year; provided, in each instance, that such revenues exceed certain minimum revenue milestones for such fiscal year.

At our option, the earn-out amounts can be settled in cash or through the issuance of additional ADSs of the Company (valued in function of a volume weighted average trading price of the Company's shares at the end of the relevant earn-out period) to Exact Sciences, provided that the aggregate number of shares representing the ADSs held by Exact Sciences shall not exceed more than 5% of our outstanding shares.

Financial Operations Overview

Revenues and Other Income

Revenues

The majority of our revenue is derived from laboratory services with revenue recognized at a point in time when control of the services has transferred to the customer. This is generally when the test results are delivered to the customer. We derive a small amount of additional revenue from license fees, royalties and government grants.

A large portion of our revenues are either derived from Medicare, which has set a fixed price pursuant to a LCD for the Company’s Confirm mdx and GPS tests, or are established with reference to the Medicare fixed price level. Therefore, the amount of revenue recognized from Medicare (as well certain contracted commercial insurance companies) for Confirm mdx and GPS is determined by reference to a fixed price pursuant to the LCD. For reimbursement claims made to other commercial insurance companies, where there is no certainty of the amount that will be paid for services rendered, the Company uses historical collection data — on an individual payor basis — to estimate its future collection and corresponding revenues that should be recognized for each of our testing solutions.

We analyze historical collection data on a monthly basis and make monthly adjustments to our estimates. In accordance with IFRS 15, revenue is recognized where such a variable consideration is included in the transaction price only to the extent that it is highly probable that the amount of revenue recognized will not be subject to significant future reversals as a result of subsequent re-estimation. When historical collection data is insufficient to estimate future collections, recognize revenue on a cash basis, meaning that revenues will not be recognized until actual cash payment is received from the payor.

Cost of Goods & Services Sold

Cost of goods sold includes the cost of materials, labor (including salaries, bonuses, and benefits), transportation, collection kits, and allocated overhead costs associated with processing samples. Allocated overhead costs include depreciation of laboratory equipment, facility occupancy and information technology costs. Costs associated with processing samples are expensed when incurred, regardless of the timing of revenue recognition. As such, cost of goods and related volume does not always trend in the same direction as revenue recognition.

Gross Profit and Gross Margin

We calculate gross profit as revenue less cost of goods & services sold, and gross margin as gross profit divided by revenue. Our gross margin has and will continue to be affected by a variety of factors, primarily average selling prices and ordering volumes. We expect our gross profit to increase in the foreseeable future as our revenue grows, our average selling price improves — based on broader commercial coverage for our tests — and as we take advantage of economies of scale as we grow test volume.

Operating Expenses

Research and Development Expenses

Research and development expenses consist of costs incurred for the development of our products. These expenses consist primarily of labor costs (including salaries, bonuses, benefits, and stock-based compensation), reagents and supplies, clinical studies, outside services, patent expenses, depreciation of laboratory equipment, facility occupancy and information technology costs. Research and development expenses also include costs associated with assay improvements and automation workflow for our current suite of products. We expense our research and development expenses in the period in which they are incurred, except for those development expenses that qualify for capitalization.

We expect that our research and development expenses will increase in absolute dollars as we continue to develop additional products, however, we expect that these expenses will decrease as a percentage of revenue over the long term, though they may fluctuate as a percentage from period to period due to the timing and extent of these expenses.

Sales and Marketing Expenses

Our sales and marketing expenses are expensed as incurred and include costs associated with our sales organization, including our direct clinical sales force and sales management, medical affairs, client services, marketing and managed care, as well as technical lab support and administration. These expenses consist primarily of labor costs (including salaries, bonuses, benefits, and stock-based compensation), customer education and promotional expenses, market analysis expenses, conference fees, travel expenses and allocated overhead costs.

While there are no immediate plans to grow the size of our commercial organization, our sales and marketing expenses may increase in absolute dollars as we increase our marketing activities to drive further awareness and adoption of our products. However, we expect that these expenses will decrease as a percentage of revenue over the long term, though they may fluctuate as a percentage from period to period due to the timing and extent of these expenses.

General and Administrative Expenses

Our general and administrative expenses include costs for certain executives, accounting and finance, legal, revenue cycle management, information technology, human resources, and administrative functions. These expenses consist primarily of labor costs (including salaries, bonuses, benefits, and stock-based compensation), professional service fees such as consulting, accounting, legal, general corporate costs, and public-company costs associated with our European listing, as well as allocated overhead costs (rent, utilities, insurance, etc.).

We expect that our general and administrative expenses will continue to increase in absolute dollars primarily due to increased headcount (some of it related to volume, such as revenue cycle management) and costs associated with operating as a public company, including expenses related to legal, accounting, regulatory, tax, maintaining compliance with exchange listing in both Belgium (EURONEXT) and the United States (Nasdaq) and requirements of the SEC, director and officer insurance and investor relations.

Other Operating Income/Expenses

Other operating income/expense is comprised of grant income, fair-value adjustment of loan facility, revaluation of the contingent consideration related to the acquisition of NovioGendix in 2015, and goodwill impairment, if any. We do not expect the revaluation of the contingent consideration to be a significant source of income or expense going forward.

Financial Income/Expenses

Financial income/expense is comprised of fair-value adjustments related to the GPS contingent consideration, interest income/expense, debt extinguishment expenses, as well as foreign exchange gain/loss and other financial gain/loss. Interest income consists primarily of interest earned on our deposits. Our interest income has not been significant to date and we do not expect it to be significant in the future. Our interest expense is primarily related to our current $35 million long-term debt facility with Innovatus Capital Partners, which replaced our previous €9 million debt facility with Kreos Capital VI (UK) Limited (“Kreos Capital”).

Foreign exchange gains/losses are derived from our operating in two different currencies (Euro and U.S. dollar) for our European and U.S. operations. These gains and losses are not expected to be significant and we maintain reserves in both currencies to offset extreme fluctuations in the dollar/euro exchange rate.

Other financial loss is derived from accrued interest charges on the fair value of the NovioGendix contingent liability.

A. Operating results

Comparison of the years ended as of December31, 2022 and 2021

Our results of operations for the years ended as of December 31, 2022 and 2021 are summarized in the tables below:

	Year Ended<br> December 31,
(in Thousands)	2022			2021				%
Services	$	36,965		$	21,937				69	%
Licenses		25			250		)		90
Royalties and other revenues		64			52				23
Revenues		37,054			22,239				67
Cost of goods & services sold		(17,835	)		(11,675	)	)		53
Gross Profit		19,219			10,564				82
Research and development expenses		(7,557	)		(6,673	)	)		13
Selling and marketing expenses		(26,582	)		(17,744	)	)		50
General and administrative expenses		(23,539	)		(14,149	)	)		66
Other operating income, net		559			1,161		)		(52	)
Operating loss		(37,900	)		(26,841	)	)		41
Financial expense, net		(6,144	)		(2,161	)	)		184
Loss before income tax		(44,044	)		(29,002	)	)		52
Income tax		—			—				—
Loss for the year		(44,044	)		(29,002	)	)		52
Earnings per share attributable to parent (EPS)
Basic and Diluted,		(0.28	)		(0.24	)	)		17

All values are in US Dollars.

Revenue

Revenue increased $14.8 million, or 67% for the year ended December 31, 2022, compared to the year ended December 31, 2021, due to both the acquisition of the GPS test as well as an increase in our test volumes for Confirm mdx and Resolve mdx. Excluding revenues from the recently acquired GPS test, total revenue for 2022 was $27.7 million, an increase of 25% versus 2021.

For the year ended December 31, 2022 and 2021, Confirm mdx accounted for 59% and 91% of total revenue, respectively. 2022 revenues were comprised of $21.8 million from Confirm mdx, $9.3 million from GPS, $4.9 million from Resolve mdx, with the remaining revenues from Select mdx and other.

Cost of Goods &Services Sold

Cost of revenue increased $6.1 million, or 53% for the year ended December 31, 2022 compared to the year ended December 31, 2021, primarily as a result of the increase in sales and unit volumes, however, gross margins increased from 47.5% for the year ended December 31, 2021 to 51.9% for the year ended December 31, 2021, a 440 basis-point improvement primarily related to our product mix and the addition of GPS to our product menu.

Research and DevelopmentExpenses

Research and development expenses increased $0.9 million, or 13% for the year ended December 31, 2022, compared to the year ended December 31, 2021, primarily due to increased product development expenses as well as expenses associated with our pipeline products.

Selling and MarketingExpenses

Selling and marketing expenses increased $8.8 million, or 50%, for the year ended December 31, 2022, compared to the year ended December 31, 2021, primarily due to the additional field sales personnel associated with the GPS business as well as an increase in amortization expense related to customer lists as part of the GPS intangible asset.

General and AdministrativeExpenses

General and administrative expense increased $9.4 million, or 66% for the year ended December 31, 2022, compared to the year ended December 31, 2021, primarily due to $3.7 million of one-time expenses related to the GPS acquisition (included in Professional fees), with the remaining $5.7 million increase primarily related to higher insurance, professional fees and public company expenses.

Other Operating Income,net

Other operating income, net, decreased by $0.6 million, or 52% for the year ended December 31, 2022, compared to the year ended December 31, 2021, primarily due to the reduction of grant income from the U.S. Department of Health and Human Services and the Dutch government NOW grants, partially offset by an increase in fair-value adjustment related to the acquisition of NovioGendix in 2015.

Financial Income/Expense

Financial expenses, net, increased by $4.0 million, or 184% for the year ended December 31, 2022, compared to the year ended December 31, 2021, primarily due to fair-value adjustment for the GPS contingent consideration of $2.4 million, interest charges and extinguishment expenses of $1.6 million for the loan facility with Kreos Capital, and interest charges of $1.6 million related to the Innovatus debt facility.

Comparison of the years ended as of December31, 2021 and 2020

Our results of operations for the years ended as of December 31, 2021 and 2020 are summarized in the tables below:

	Year Ended<br> December 31,
(in Thousands)	2021			2020				%
Services	$	21,937		$	18,064				21	%
Licenses		250			250				—
Royalties and other revenues		52			146		)		(64	)
Revenues		22,239			18,460				20
Cost of goods & services sold		(11,675	)		(10,416	)			12
Gross Profit		10,564			8,044				31
Research and development expenses		(6,673	)		(4,543	)	)		47
Selling and marketing expenses		(17,744	)		(16,752	)	)		6
General and administrative expenses		(14,149	)		(13,990	)	)		1
Other operating income, net		1,161			118				884
Operating loss		(26,841	)		(27,123	)			(1	)
Financial income		11			4				175
Financial expense		(2,172	)		(1,543	)	)		41
Loss before income tax		(29,002	)		(28,662	)	)		1
Income tax		—			—				—
Loss for the year		(29,002	)		(28,662	)	)		1
Earnings per share attributable to parent (EPS)
Basic and Diluted		(0.24	)		(0.34	)			(29	)

All values are in US Dollars.

Revenue

Revenue increased $3.8 million, or 20% for the year ended December 31, 2021, compared to the year ended December 31, 2020, due an increase in our test volumes and average selling price.

For the year ended December 31, 2021 and 2020, Confirm mdx accounted for 91% and 94% of total revenue, respectively.

Cost of Goods &Services Sold

Cost of revenue increased $1.3 million, or 12% for the year ended December 31, 2021 compared to the year ended December 31, 2020, primarily as a result of the increase in unit volumes, however, gross margins increased from 43.6% for the year ended December 31, 2020 to 47.5% for the year ended December 31, 2021, a 390 basis-point improvement primarily due to the increase in our average selling price.

Research and DevelopmentExpenses

Research and development expenses increased $2.1 million, or 47% for the year ended December 31, 2021, compared to the year ended December 31, 2020, primarily due to increased expenses associated with our pipeline products.

Selling and MarketingExpenses

Selling and marketing expenses increased $1.0 million, or 6%, for the year ended December 31, 2021, compared to the year ended December 31, 2020, primarily due to increased activity in 2021 versus 2020, which was the first year of the COVID-19 pandemic.

General and AdministrativeExpenses

General and administrative expense increased $0.2 million, or 1% for the year ended December 31, 2021, compared to the year ended December 31, 2020, primarily due to an increase in professional fees and insurance expenses associated with our U.S. listing on the Nasdaq Stock Market.

Other Operating Income,net

Other operating income, net was comprised of grant income in the U.S. and The Netherlands as well as the revaluation of the contingent consideration related to the acquisition of NovioGendix in 2015. The increase of $1.0 million for the year ended December 31, 2021 versus the prior year period was primarily related to $659,000 grant income from the U.S. Department of Health and Human Services as well as a $382,000 grant from the Dutch government NOW grants.

Financial Income/Expense

Financial income was comprised of interest income from deposits. Financial expense is primarily comprised of interest expense on our long-term debt facility as well as interest charges on lease liabilities. Financial expenses increased by $0.6 million, or 41% primarily related to interest charges recognized on leases under IFRS 16.

B. Liquidity and Capital Resources

We have incurred net losses in each quarter since our inception. For the years ended December 31, 2022, 2021 and 2020, we incurred a net loss of $44.0 million, $29.0 million and $28.7 million respectively. We expect to continue to incur significant expenses for the foreseeable future and to incur operating losses in the near term while we make investments to support our anticipated growth.

As of December 31, 2022, we have been financed primarily through net proceeds of approximately $360 million from the sale of our equity securities and long-term debt facilities. Our primary source of cash from operations is cash receipts on accounts receivable from our revenue. As of December 31, 2022, we had cash and cash equivalents of $15.5 million and an accumulated deficit of $288.3 million.

On February 3, 2023, we announced the pricing of a registered public offering of 10,000,000 ADSs (each representing 10 ordinary shares of the Company without nominal value) at a price to the public of $4.00 per ADS (equivalent to a price of €0.364 per share, assuming an exchange rate of €1 = $1.0988 as published by the European Central bank on February 2, 2023 and a 10-for-1 ADS to share ratio) for total gross proceeds of $40.0 million before deducting commissions and estimated offering expenses.

On March 6, 2023, we announced that, in the context of the above-mentioned offering, the underwriters exercised the option to purchase additional ADSs, on the same terms and conditions as stated above, in the amount of 750,000 ADSs for gross proceeds of $3.0 million, bringing the aggregate gross proceeds from this transaction to $43.0 million.

Our primary uses of cash are to fund operating expenses, service debt and acquire equipment. Cash used to fund operating expenses excludes the impact of non-cash items such as depreciation and stock-based compensation and is impacted by the timing of when we pay our operating expenses as reflected in the change in our outstanding accounts payable and accrued expenses. Debt service primarily consists of interest payments on our outstanding debt. Acquisitions of property and equipment primarily consist of purchases of laboratory equipment.

On August 2, 2022, we entered into a $70 million loan and security agreement with Innovatus, which loan also replaced the Company’s €9 million debt facility with Kreos Capital. At closing, an amount of $35 million was drawn, with an additional $35 million remaining available as a $20 million term B loan and a $15 million term C loan that can be drawn in 2024 and 2025 respectively, subject to certain conditions. The loans are secured by our assets including intellectual property rights. Remaining proceeds of the loans will be used for working capital purposes and to fund general business requirements.

The loans accrue interest at a floating per annum rate equal to the sum of (a) the greater of (i) the prime rate published in The Wall Street Journal in the “Money Rates” section or (ii) 4.00%, plus (b) 4.25%, and require interest-only payments for the initial four years. As contractually agreed, and at our election, a portion of the interest becomes payable in-kind by adding an amount equal to 2.25% of the outstanding principal amount to the then outstanding principal balance on a monthly basis until August 2, 2025. The loans mature on August 2, 2027. The lenders shall have the right to convert, prior to August 2, 2025, up to 15% of the outstanding principal amount of the loans into ADSs of the Company at a price per ADS equal to $11.21, reflecting a substantial premium to the trading price prior to the announcement of the acquisition. Amounts converted into ADSs of the Company will be reduced from the principal amount outstanding under the loan. Notable fees payable to Innovatus consist of a facility fee equal to 1% of the total loan commitment, due on the funding date of the relevant loans, and an end-of-loan fee equal to 5% of the amount drawn, payable upon final repayment of the relevant loans.

In April 2020, the Company, through our U.S. subsidiary, MDxHealth Inc., entered into a PPP loan with the SBA in the amount of $2,316,000 as part of the CARES Act. The loan has a term of five years and carries an interest rate of 1.0% per year. Payments on the loan are deferred for the first eighteen months following disbursement of the loan, with principal and interest payments beginning on the nineteenth month. Interest on the loan continues to accrue during the eighteen-month deferment period. Cash proceeds from the loan were received in July 2020. Of the $2.3 million PPP loan, $1.6 million and $1.0 million has been recorded as long-term debt on the company’s consolidated balance sheet as of December 31, 2021, and December 31, 2022, respectively.

Funding Requirements

As of December 31, 2022, we had cash and cash equivalents of $15.5 million. Based on our current business plan, as well as the additional $40.4 million in net proceeds from our February and March 2023 equity offering, we estimate that our current cash and cash equivalents and our anticipated cash flows generated from sales of our products, will be sufficient to meet our anticipated cash requirements over at least the next 12 months from the date of this annual report. To meet our long-term financial needs, we may consider raising additional capital to expand our business, to pursue strategic investments, to take advantage of financing opportunities or for other reasons. As a result of our expected revenue growth, we expect our accounts receivable and inventory balances to increase. Any increase in accounts receivable and inventory may not fully cover corresponding increases in accounts payable and accrued expenses, which could result in greater working capital requirements. We have based these estimates on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we expect.

Until such time, if ever, as we can generate revenue to support our cost structure, we expect to finance our operations through equity offerings or debt financings, or other capital resources, including potentially collaborations or licensing arrangements. The sale of equity and convertible debt securities may result in dilution to our shareholders and the terms of these securities could provide for rights, preferences or privileges senior to those of our common stock. The terms of debt securities issued or borrowings pursuant to a credit agreement could impose significant restrictions on our operations. If we raise funds through collaborations and licensing arrangements, we might be required to relinquish significant rights to our technologies or products or grant licenses on terms that are not favorable to us. Additional capital may not be available on reasonable terms, or at all.

Our ability to generate sufficient revenue to achieve profitability will be heavily dependent on the successful commercialization of our currently marketed products and our anticipated future products, as well as obtaining favorable reimbursement. We anticipate that a substantial portion of our capital resources and efforts in the foreseeable future will be focused on the commercialization of our existing products and the development of future products.

Our operating results may fluctuate significantly from period to period, depending on the timing of our planned development activities, clinical studies, and the growth of our sales and marketing activities. We expect our expenses will increase substantially for the foreseeable future as we:

●	attract,<br>hire and retain qualified personnel;
●	continue<br>to develop additional products and generate any evidence required to support expanded reimbursement of our products;
---	---
●	expand<br>our sales force and territories and increase our marketing activities to drive further awareness and adoption of our products;
---	---
●	protect<br>and defend our intellectual property;
---	---
●	invest<br>in processes, infrastructure to support the growth of our business; and
---	---
●	operate<br>as a dual-listed public company.
---	---

The table below summarizes our cash flows information for the years ended December 31, 2022 and 2021.

	For the year ended<br> December 31,
(in Thousands)	2022			2021
Net cash used in operations	$	(34,118	)	$	(22,548	)
Net cash used in investing activities		(29,163	)		(896	)
Net cash from financing activities		20,841			66,509
Effects of exchange rate changes		(555	)		(520	)
Change in cash and cash equivalents	$	(42,995	)	$	(42,545	)

Net cash used in operations was $34.1 million for year ended December 31, 2022, compared to $22.5 million for the year ended December 31, 2021. The increase of cash used in operations of $11.6 million was primarily due to a higher operating loss as well as negative variation in our working capital.

Net cash from investing activities for the year ended December 31, 2022, was $29.2 million compared to $0.9 million for the year ended December 31, 2021. The increase in net cash from investing activities primarily related to the acquisition of the GPS business as well as to purchases of property, plant, and equipment during 2022.

Net cash from financing activities for year ended December 31, 2022, was $20.8 million compared to $66.5 million for the year ended December 31, 2021. Cash from financing activities for the year ended December 31, 2022 were primarily derived from the $35 million debt facility from Innovatus. Cash from financing activities for the year ended December 31, 2021 were primarily from an equity financing of €25.0 million ($30.4 million) in gross proceeds by means of a private placement of 27,777,777 new shares (being approximately 30.63% of the Company’s outstanding shares at the time) at an issue price of €0.90 per share through an accelerated bookbuild offering as well as from an initial public offering in the United states of 3,750,000 ADSs (representing 37,500,000 ordinary shares, being approximately 32% of the Company’s outstanding shares at the time) for gross proceeds of $45.0 million.

Cash Flows

The table below summarizes our cash flows information for the years ended December 31, 2021 and 2020.

	For the year ended<br> December 31,
(in Thousands)	2021			2020
Net cash used in operations	$	(22,548	)	$	(20,244	)
Net cash used in investing activities		(896	)		(537	)
Net cash from financing activities		66,509			14,290
Effects of exchange rate changes		(520	)		394
Change in cash and cash equivalents	$	42,545		$	(6,097	)

Net cash used in operations was $22.5 million for year ended December 31, 2021, compared to $20.2 million for the year ended December 31, 2020. The increase of cash used in operations of $2.3 million was primarily due to negative variation in our working capital.

Net cash from investing activities for the year ended December 31, 2021, was $0.9 million compared to $0.5 million for the year ended December 31, 2020. The increase in net cash from investing activities related to purchases of property, plant, and equipment during 2021.

Net cash from financing activities for year ended December 31, 2021, was $66.5 million compared to $14.3 million for the year ended December 31, 2020. Cash from financing activities for the year ended December 31, 2021 were primarily from an equity financing of €25.0 million ($30.4 million) in gross proceeds by means of a private placement of 27,777,777 new shares (being approximately 30.63% of the Company’s outstanding shares at the time) at an issue price of €0.90 per share through an accelerated bookbuild offering as well as from an initial public offering in the United States of 3,750,000 ADSs (representing 37,500,000 ordinary shares, being approximately 32% of the Company’s outstanding shares at the time) for gross proceeds of $45.0 million. Cash from financing activities for the year ended December 31, 2020, were primarily from an equity investment in the Company by MVM V LP and MVM GP (No.5) LP, funds managed by MVM Partners LLP (collectively “MVM”) of $13.7 million as well as proceeds of $2.3 million from the PPP loan with the SBA as part of the CARES Act.

Contractual Obligations and Commitments

Our principal obligations consist of a lease liability, financial debt and trade and other payables. The following table sets out, as of December 31, 2022, our contractual obligations and commitments due by period:

	Payments Due by Period
(in thousands)	Total		Less than<br> 1 Year		1 – 3<br> Years		4 – 5<br> Years		More than<br> 5 Years
Loans and borrowings	$	35,530	$	616	$	989	$	33,925	$	0
Lease liabilities		4,263		1,172		2,128		963		0
Total	$	39,793	$	1,788	$	3,117	$	34,889	$	0

The contractual obligations table does not include any additional potential contingent payments upon the future achievement by us of specified sales-based and other milestones, or royalty payments we may be required to make under license agreements we have entered into pursuant to which we have in-licensed certain intellectual property or under the agreement pursuant to which we acquired the GPS test. See “Collaboration and License Agreements” under Item 4B. “Business Overview” for additional information. The timing of when these additional payments will actually be made is uncertain and the payments are contingent upon the completion of future activities.

C. Research and development, patents and licenses

Our research and development teams utilize our deep expertise to contribute to the growth of our business. In the years ended December 31, 2020, 2021 and 2022, R&D expenses were $4.5 million, $6.7 million and $7.6 million, respectively, on research and development. For a discussion of our research and development activities, see Item 4B. “Business Overview” and Item 5A. “Operating Results.”

D. Trend information

Key Factors and Trends

Impact of COVID-19 Pandemic

The broad and extensive impact of the COVID-19 pandemic on virtually all aspects of our business and society exacerbated many pre-existing risks to our business by making them more likely to occur or more impactful when they do occur. The level and nature of the disruption caused by COVID-19, or any future pandemic, is unpredictable, may be cyclical and long-lasting and may vary from location to location. To the extent COVID-19 conditions improve, the duration and sustainability of any such improvements will be uncertain and continuing adverse impacts and/or the degree of improvement may vary dramatically by geography and by product. The actions we take in response to any improvements in conditions, such as our return-to-office plans, may also vary widely by geography and by business and will likely be made with incomplete information; pose the risk that such actions may prove to be premature, incorrect or insufficient and could have a material, adverse impact on our business and results of operations.

Ability to Attract New Ordering Physiciansand Increase Our Penetration with Existing Physicians

Revenue growth for our products will depend on our ability to continue to expand our base of ordering physicians, increase our penetration with existing physician customers, and increase the number of physicians who consistently order our tests. We do not have immediate plans to expand our direct sales force and believe that we have the ability to increase our base of ordering physicians with our current structure.

Reimbursement for Genomic Testing fromThird-Party Payors

Successful commercialization of our tests depends, in large part, on the availability of coverage and adequate reimbursement from government and private payors. Favorable third-party payor coverage and reimbursement are essential to meeting the Company’s immediate objectives and long-term commercial goals. In the United States, for new diagnostic solutions, each private and government payor decides whether to cover the test, the amount it will reimburse for a covered test, and any the specific conditions for reimbursement. Providers may be unlikely to order a specific diagnostic test unless an applicable third-party payor offers meaningful reimbursement for the test. Therefore, adequate coverage and reimbursement is critical to the commercial success of a diagnostic product, and if the Company is unable to secure and maintain favorable coverage determinations and reimbursement levels, this will compromise its ability to earn revenues from its products.

Medicare

Reimbursement for diagnostic tests furnished to Medicare beneficiaries is typically based on a fee schedule set by CMS. As a Medicare-enrolled laboratory based in California, the Company bills Noridian, and is subject to applicable Medicare local coverage and reimbursement policies. Noridian participates in the MolDX, which handles technical assessments for U.S. laboratories that perform molecular diagnostic testing. In 2014, 2015 and 2023, respectively, our Confirm mdx test, our GPS test and our Select mdx test received a positive Medicare LCDs under the MoIDX Program, which provide coverage and reimbursement for Medicare beneficiaries throughout the United States. Our Resolve mdx UTI test is currently reimbursed by Medicare and most private insurance payors, based on nationally recognized CPT codes.

Commercial payors

Obtaining coverage and reimbursement by commercial payors is a time-consuming and costly process, without a guaranteed outcome, since each commercial payor makes its own decision with respect to whether to cover a particular test, and, if so, at what rate to reimburse providers for such test. In addition, several payors and other entities conduct technology assessments of new medical tests and devices and provide the results of these assessments for informational purposes to other parties. These assessments may be used by third-party payors and healthcare providers as grounds to deny coverage for a particular test, or to refuse to use or order a particular test or procedure. The Confirm mdx and Select mdx tests have received initial negative technology assessments from several of these entities and are likely to receive more negative technology assessments. The Company continues to work with third-party payors to obtain coverage for its Confirm mdx and Select mdx tests and to appeal denial decisions based on existing and ongoing studies, peer reviewed publications, and support from physician and patient groups. There are no assurances that commercial payors will continue to issue positive coverage and reimbursement policies and/or contracts, and, if issued, that such policies and/or contracts will be maintained in the future. If the Company’s tests are considered on a policy-wide level by major third-party payors, whether at the Company’s request or on their own initiative, and the tests are determined to be ineligible for coverage and reimbursement by such payors, the Company’s collection efforts and potential for revenue growth could be adversely impacted.

Increasing Market Acceptance and Adoptionof our Tests

Healthcare providers typically take a long time to adopt new products, testing practices and clinical treatments, partly because of perceived liability risks and the uncertainty of third-party coverage and reimbursement. It is critical to the success of our sales efforts that we educate enough patients, clinicians and administrators about molecular diagnostics testing, in general, as well as about our Confirm mdx and Select mdx tests, and demonstrate our clinical benefits. It is likely that clinicians may not adopt, and third-party payors may not cover or adequately reimburse for, the Company’s tests unless they determine, based on published peer-reviewed journal articles and the experience of other clinicians, that they provide accurate, reliable and cost-effective information.

Menu Expansion

Our lead products address men at risk for developing prostate cancer, but in addition, we are actively developing testing solutions to help with the management of men diagnosed with prostate cancer, with the goal to provide our clients with a menu of tools spanning the continuum of prostate cancer diagnosis and care. Our expertise in precision diagnostics and our portfolio of novel biomarkers for diagnostic, prognostic and predictive molecular assays supports our active pipeline of new testing solutions for prostate and other urologic diseases. Our pipeline products in active surveillance are still under development and may or may not make it to market, depending on results of our research and clinical studies. The completion of these research and development activities is difficult to predict, and the related expenses may vary significantly by quarter. We expect to increase our research and development expense during this time. We may also take advantage of our strong commercial channel into urology to introduce complimentary tests outside of our current pipeline products.

While these factors may present significant opportunities for us, they also pose significant risks and challenges that we must address. See Item 3D. “Risk Factors” for more information.

E. Critical Accounting Estimates

Critical Accounting Policies and Estimates

Refer to Note 2.4 to our consolidated financial statements found elsewhere in this annual report, for a discussion on the critical accounting policies, estimates, assumptions, and judgments that we believe to have the most significant impact on our consolidated financial statements.

ITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES

A. Directors and Senior Management

Our Board of Directors

The following table sets forth certain information relating to our Board of Directors as of December 31, 2022.

Name	Age	Position(s)	Term
Koen Hoffman^(1)^	54	Independent Non-Executive Director (Chairperson of<br> the Board of Directors)	Until 2024
Michael K. McGarrity	60	Executive Director (Chief Executive Officer)	Until 2023^(2)^
Jan Pensaert^(3)^	51	Non-Executive Director	Until 2024
Dr. Lieve Verplancke^(4)^	63	Independent Non-Executive Director	Until 2024
Hilde Windels^(5)^	57	Independent Non-Executive Director	Until 2023^(2)^
Dr. Regine Slagmulder^(6)^	56	Independent Non-Executive Director	Until 2023^(2)^
Dr. Eric Bednarski	51	Non-Executive Director	Until 2023^(2)^
Donnie (Don) M. Hardison	72	Independent Non-Executive Director	Until 2023^(2)^
^(1)^	Acting through Ahok BV.
---	---
^(2)^	Director is up for reelection<br> to a new mandate on May 2023 at our shareholder meeting.
^(3)^	Acting through Valiance<br> Advisors LLP.
---	---
^(4)^	Acting through Qaly-Co BV.
---	---
^(5)^	Acting through Hilde Windels<br> BV.
---	---
^(6)^	Acting through Regine Slagmulder<br> BV.
---	---

Unless otherwise stated, the address for our directors is CAP Business Center, Zone Industrielle des Hauts-Sarts, Rue d’Abhooz 31, 4040 Herstal, Belgium.

Our Board of Directors has determined that five out of eight of the members of the Board are independent under Belgian law and the Nasdaq Stock Market listing requirements.

Except for our employment agreement with Michael K. McGarrity, our Executive Director and Chief Executive Officer, as described in “Item 7B. Related Party Transactions,” there are no service contracts between us and any of our directors providing for benefits upon termination of employment.

Board Diversity Matrix
(as of November 1, 2022)
Country<br> of Principal Executive Offices:	Belgium
Foreign<br> Private Issuer	Yes
Disclosure<br> Prohibited under Home Country Law	Yes
Total<br> Number of Directors	8
	Female	Male	Non-Binary	Did Not Disclose Gender
Part I: Gender Identity
Directors	3	5	-	-
Part II: Demographic Background
Underrepresented Individual in Home Country Jurisdiction			-
LGBTQ+			-
Did<br> Not Disclose Demographic Background			-
(as of April 25, 2023)
---	---	---	---	---
Country<br> of Principal Executive Offices:	Belgium
Foreign<br> Private Issuer	Yes
Disclosure<br> Prohibited under Home Country Law	Yes
Total<br> Number of Directors	8
	Female	Male	Non-Binary	Did Not Disclose Gender
Part I: Gender Identity
Directors	3	5	-	-
Part II: Demographic Background
Underrepresented Individual in Home Country Jurisdiction			-
LGBTQ+			-
Did<br> Not Disclose Demographic Background			-

The following sets forth the biographical information of the members of our board of directors:

Koen Hoffman, Chairperson of our Board of Directors, obtained a Master in Applied Economics and an MBA at Vlerick Business School. Between 1992 and July 2016, he was active at KBC Group in which he started his career in the corporate finance department and later became the CEO of KBC Securities as from October 2012. Since August 2016, he is the CEO of Value Square asset management. Mr Koen Hoffman serves also as board member at Fagron (Chair),Greenyard (chair), Mithra Pharmaceuticals and SnowWorld.

Michael K. McGarrity, Chief Executive Officer and Executive Director of our Company, has more than 25 years of experience in the healthcare industry with a unique combination of device, diagnostics and biotechnology experience. Michael was most recently the CEO of Sterilis Medical. Prior to Sterilis Michael was the CEO of Nanosphere (Nasdaq: NSPH), a nanotechnology-based molecular diagnostics company, where he engineered an operational and strategic turnaround that resulted in its successful sale to Luminex (Nasdaq: LMNX) in 2016. Prior to Nanosphere, McGarrity spent 13 years at Stryker Corporation (NYSE: SYK). Mr. McGarrity holds a BA from the University of Notre Dame.

Jan Pensaert, Non-Independent Non-Executive Director of our Company, is the Founding Managing Partner of Valiance. He brings over 20 years of experience in growth investing. He leads the Investment Committee for the Valiance Funds and is responsible for all aspects of the Funds’ investment processes. Jan currently serves on the Board of several Valiance entities funds and portfolio companies including MDxHealth, JenaValve, NeoSync and 4Tech. Prior to founding Valiance, Jan was CEO of La Fayette, where during his tenure the La Fayette Funds increased in AUM from USD 750 million to USD 5.5 billion. Before that, he was responsible for the Permal Group’s European-based investment management and research activities, and prior to that he worked at Lazard in Corporate Finance M&A. Jan holds a BA in Business Economics from Gent University in Belgium, and a Masters in Banking & Finance from the University of Aix-Marseille, France.

Dr. Lieve VerplanckeMD, Independent Non-Executive Director of our Company, a Belgian national, began her career in 1984 with The Beecham Group (now part of GlaxoSmithKline), and has since held key management positions with Merck & Co., as well as Bristol-Myers Squibb, where she served as Managing Director, leading their Belgian/GDL subsidiary, until 2012. Ms. Verplancke also serves as a Board Member for Brussels-based Europe Hospitals; the Imelda Hospital in Bonheiden; and the Euronext fund, Quest for Growth and Materialise. She is also the Founder and Managing Director of Qaly@Beersel, an elderly care center in Belgium. In addition to being a medical doctor (MD–KULeuven University), Ms. Verplancke holds a postgraduate degree in Economics and an MBA from the University of Antwerp. She has also completed courses at INSEAD, CEDEP, Columbia University and the Vlerick Business School, and is a certified Executive Coach (PCC).

Hilde Windels, Independent Non-Executive Director of our Company, is the CEO of immunodiagnostic company Antelope Dx BV and has 20 years of experience in the biotechnology sector with a track record of building and structuring organizations, fundraising, M&A, public capital markets and corporate strategies. At Biocartis, she was CEO ad interim and Deputy CEO from September 2015 until September 2017 and CFO from 2011 until September 2015. Previously, Mrs. Windels worked as independent CFO for several private biotech companies and from 1999 to 2008 she was CFO of Devgen. Currently, Mrs. Windels serves as a board member at Erytech and Celyad. In the past, she also served on the boards of Devgen, Biocartis, Ablynx, VIB and FlandersBio. Mrs. Windels holds a Masters in Economics (commercial engineer) from the University of Leuven, Belgium.

Dr. Regine Slagmulder, Independent Non-Executive Director of our Company, is a partner and full professor in management accounting & control at Vlerick Business School and a visiting professor of accounting & control at INSEAD. Previously, she worked as a strategy practice consultant at McKinsey & Company. She also previously worked as a professor of management accounting at INSEAD and at the University of Tilburg. She serves as an independent director and member of the audit committee on the board of the investment company Quest for Growth (since 2011) and as an independent director and chair of the audit committee of Ekopak (since 2021), both listed on Euronext. Dr. Slagmulder graduated in civil electrotechnical engineering and industrial management from the University of Gent, after which she received a management doctorate at Vlerick Business School. As part of her research activities, she was a research fellow attached to INSEAD, Boston University (USA) and the P. Drucker Graduate Management Center at Claremont University (USA). She is an INSEAD certified director (IDP-C).

Dr. Eric Bednarski, Non-Independent Non-Executive Director of our Company, **** currently serves as a Partner of MVM Partners LLP. Before joining MVM in 2008, he was a Partner at Advent Healthcare Ventures and a Principal at Advent International Corporation. Prior to Advent, he was a Director in the Corporate Finance Group of Silicon Valley Bank. Dr. Bednarski has a B.S. degree in Neural Science from Brown University and a Ph.D. in Biological Sciences from the University of California, Irvine.

Donnie (Don) M. Hardison, Independent Non-Executive Director of our Company, currently is the sole proprietor of DMH Consulting, a management consulting firm that he founded and previously operated from April 2016 to January 2017. He was most recently the President and Chief Executive Officer, and served on the board of directors, of Biotheranostics, Inc., a molecular diagnostic company focused on oncology, from February 2017 until it was acquired by Hologic, Inc. in February 2021. From April 2010 to March 2016, Mr. Hardison was the President and Chief Executive Officer of Good Start Genetics, a molecular genetic testing and information company. For more than 20 years prior to that, Mr. Hardison held various executive and senior management positions at companies including Laboratory Corporation of America (LabCorp) a clinical laboratory company, Exact Sciences Corporation, a molecular diagnostics company, OnTarget, Inc., a sales and marketing consulting company, Quest Diagnostics Inc., a clinical laboratory company, SmithKline Beecham Corporation, a pharmaceutical company, and others. He served on the board of directors of Exact Sciences Corporation (Nasdaq: EXAS) from May 2000, through its initial public offering in February 2001, until August 2007. Mr. Hardison received his Bachelor of Arts degree, in political science, from the University of North Carolina, Chapel Hill.

Our Executive Management

The following table sets forth certain information relating to our executive management as of December 31, 2022.

Name	Age	Position(s)
Michael K. McGarrity	60	Chief Executive Officer and Executive Director
John Bellano	54	Chief Commercial Officer
Ron Kalfus	48	Chief Financial Officer
Joseph Sollee	58	Executive Vice President of Corporate Development and<br> General Counsel

Unless otherwise stated, the address for our executive management is CAP Business Center, Zone Industrielle des Hauts-Sarts, Rue d’Abhooz 31, 4040 Herstal, Belgium.

The following is the biographical information of those members of our executive management who do not also serve on our Board of Directors:

John Bellano, our Chief Commercial Officer, joined MDxHealth in June 2019. He has more than 25 years of experience in the healthcare industry. Mr. Bellano started his career in pharmaceuticals and transitioned to molecular diagnostics where he has spent the past 20 years of his career, most recently as Chief Commercial Officer of Sterilis Solutions. Prior to Sterilis Solutions he served as the commercial leader for pharmacogenomic companies Assurex Health and AltheaDx. Mr. Bellano holds a degree from Allentown College.

Ron Kalfus, our Chief Financial Officer, joined MDxHealth in July 2019. He has over 20 years of leadership experience in both public and private companies within diagnostics/biotech and other sectors, and brings extensive knowledge in financial operations and management. Mr. Kalfus joined MDxHealth from Rosetta Genomics, where he helped lead efforts to reposition the company for commercial success with its oncology diagnostic products. Prior to Rosetta, Mr. Kalfus served as the CFO and Treasurer of MabCure, a Belgium-based publicly-traded biotechnology start up in the field of early cancer detection using antibodies. Mr. Kalfus holds a MS in Accounting from Fairleigh Dickinson University and a BBA in Finance from the University of Georgia and is a CPA licensed in New Jersey.

Joseph Sollee, our Executive Vice President of Corporate Development and General Counsel, has provided legal counsel to MDxHealth since its inception in 2003, and in April 2008 joined our management team. Prior to joining the Company, Mr. Sollee served as Special Counsel with the law firm of Kennedy Covington (now K&L Gates), where he led the Life Sciences Practice Group. Mr. Sollee has more than 20 years of experience in the life sciences industry, and has held senior legal and management positions at Triangle Pharmaceuticals and TherapyEdge. In addition, he has practiced as a corporate attorney in the Washington D.C. legal firm Swidler & Berlin and in investment banking at Smith Barney in New York. Mr. Sollee received a Juris Doctorate in Law (JD) and a Master’s degree in International & Comparative Law (LLM) from Duke University, a BA degree from Harvard University, and has been certified into the legal bars of New York, Washington D.C. and North Carolina.

Family Relationships

There are no family relationships among any of the members of our executive management and/or our Board of Directors.

B. Compensation

Compensation of Our Directors and ExecutiveManagement

Our current remuneration policy is based on meritocracy and a sense of ownership and is designed to reward performance in order to motivate members of the Board of Directors and the executive management of the Company in order to deliver increased shareholder value through superior business results.

We have prepared and submitted a remuneration policy in accordance article 7:89/1 of the Belgian Companies and Associations Code to the general shareholders’ meeting of the Company, which approved said remuneration policy on May 27, 2021. Upon every material change to the remuneration policy and in any case at least every four years, the remuneration policy will be submitted to the general shareholders’ meeting for approval. The shareholders’ vote on the remuneration policy is binding.

Compensation of Our Board of Directors

Upon recommendation and proposal of the Nomination and Remuneration Committee, our Board of Directors determines the remuneration of the directors to be proposed to the general shareholders’ meeting.

Pursuant to Belgian law, the general shareholders’ meeting approves the remuneration of the directors, including inter alia, each time as relevant:

a.	in relation to the remuneration<br> of executive and non-executive directors, the exemption from the rule that share based awards can only vest after a period of<br> at least three years as of the grant of the awards (article 7:91, first subsection of the Belgian Companies and Associations Code);
b.	in relation to the remuneration<br> of executive directors, the exemption from the rule that (unless the variable remuneration is less than a quarter of the annual remuneration)<br> at least one quarter of the variable remuneration must be based on performance criteria that have been determined in advance and<br> that can be measured objectively over a period of at least two years and that at least another quarter of the variable remuneration<br> must be based on performance criteria that have been determined in advance and that can be measured objectively over a period of<br> at least three years (article 7:91, second to fourth subsection of the Belgian Companies and Associations Code);
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c.	in relation to the remuneration<br> of non-executive directors, any variable part of the remuneration (independent directors can never receive a variable remuneration)<br> (Article 7:92, fourth and fifth subsection of the Belgian Companies and Associations Code); and
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d.	any provisions of service<br> agreements to be entered into with executive directors providing for severance payments exceeding twelve months’ remuneration<br> and if the severance payments exceed eighteen months’ remuneration, only with the prior recommendation of the Nomination and<br> Remuneration Committee (article 7:92, first subsection of the Belgian Companies and Associations Code).
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Notwithstanding points (a) and (b) above, pursuant to our Articles of Association, our Board of Directors is explicitly authorized to deviate from the provisions of article 7:91 of the Belgian Companies and Associations Code.

The level and structure of the remuneration of the members of the Board of Directors are determined based on their general and specific responsibilities and market practice. Our shareholders approved the following annual remuneration and compensation of the members of the Board of Directors:

	Compensation
	(in )	(in )
Chairman – Non-Executive Director
Non-Executive Director (including Independent Directors)
Additional fee for the Chair of the Audit Committee
Additional fee for a Member of the Audit Committee (other than<br> the Chair of the Audit Committee)
Additional fee for the Chair of the Nomination and Remuneration<br> Committee
Additional fee for a Member Nomination and Remuneration Committee<br> Member (other than the Chair of the Nomination and Remuneration Committee)

All values are in Euros.

The abovementioned remuneration can be reduced prorata temporis depending on the duration of the mandate, chairpersonship or membership of a director during a given year. The abovementioned amounts are exclusive of VAT and similar charges.

Directors are not entitled to any kind of performance cash bonus or other kind of variable remuneration.

Mr. McGarrity, our Chief Executive Officer, Executive Director and a member of our Board of Directors, does not receive any compensation for his service as a director.

Additionally, directors are not entitled to any kind of compensation when their mandate ends.

For 2022, the following remuneration or compensation was due to the directors (excluding Mr. McGarrity):

	Compensation
	(in )	(in )
Koen Hoffman^(1)^
Jan Pensaert^(2)^
Dr. Lieve Verplancke^(3)^
Hilde Windels^(4)^
Dr. Regine Slagmulder^(5)^
Dr. Eric Bednarski
Donnie (Don) M. Hardison

All values are in Euros.

^(1)^	Acting through Ahok BV.
^(2)^	Acting through Valiance<br> Advisors LLP.
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^(3)^	Acting through Qaly-Co BV.
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^(4)^	Acting through Hilde Windels<br> BV.
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^(5)^	Acting through Regine Slagmulder<br> BV.
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The table below provides an overview as of December 31, 2022, of the subscription rights, or options, held by the non-executive directors.

	Options
Name	Number of<br> Ordinary Shares<br><br> Underlying the<br> Options	Option Exercise<br> Price per<br><br> Ordinary Share<br> Underlying the<br> Options<br> (in EUR)	Option<br> Expiration<br> Date
Koen Hoffman^(1)^	10,000<br> 20,000	4.97<br> 1.28	June 18, 2027<br> June 20, 2029
Jan Pensaert^(2)^	4,000<br> 10,000<br> 10,000<br> 10,000<br> 10,000<br> 10,000<br> 10,000<br> 10,000 <br>10,000	4.13<br> 4.91<br> 4.13<br> 4.97<br> 4.97<br> 1.28<br> 1.28<br> 1.375 <br>0.797	June 22, 2024<br> June 22, 2024<br> June 22, 2024<br> June 18, 2027<br> June 18, 2027<br> June 20,<br> 2029<br> June 20, 2029<br> May 26, 2031 <br>May 25, 2032
Dr.<br> Lieve Verplancke^(3)^	10,000<br> 10,000<br> 10,000	4.97<br> 4.97<br> 1.28	June 18, 2027<br> June 18, 2027<br> June 20, 2029
Hilde<br> Windels^(4)^	10,000<br> 10,000	4.97<br> 1.28	June 18, 2027<br> June 20, 2029
Dr.<br> Regine Slagmulder^(5)^	None
Dr. Eric Bednarski	None
Donnie (Don) M. Hardison	None
^(1)^	Acting<br> through Ahok BV.
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^(2)^	Acting<br> through Valiance Advisors LLP.
^(3)^	Acting<br> through Qaly-Co BV.
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^(4)^	Acting<br> through Hilde Windels BV.
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^(5)^	Acting<br> through Regine Slagmulder BV.
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Compensation of Our Executive Management

The remuneration of the Chief Executive Officer and the other members of our executive management is based on recommendations made by our Nomination and Remuneration Committee. The Chief Executive Officer can, and will in principle be invited to, participate in an advisory capacity to the meetings of the committee when it deals with the remuneration of other executive managers.

The remuneration of our executive management is determined by our Board of Directors, in accordance with the current remuneration policy pursuant to Article 7:89/1 Belgian Companies and Associations Code, as approved by the general shareholders’ meeting of May 27, 2021.

As an exception to the foregoing rule, Belgian law provides that the general shareholders’ meeting must approve, as relevant:

a.	in relation to the remuneration<br> of members of the executive management and other executives, an exemption from the rule that share-based awards can only vest<br> after a period of at least three years as of the grant of the awards (article 7:121, last subsection juncto article<br> 7:91, first subsection of the Belgian Companies and Associations Code);
b.	in relation to the remuneration<br> of members of the executive management and other executives, an exemption from the rule that (unless the variable remuneration is<br> less than a quarter of the annual remuneration) at least one quarter of the variable remuneration must be based on performance criteria<br> that have been determined in advance and that can be measured objectively over a period of at least two years and that at least another<br> quarter of the variable remuneration must be based on performance criteria that have been determined in advance and that can be measured<br> objectively over a period of at least three years (article 7:121, last subsection juncto article 7:91, second to<br> fourth subsection of the Belgian Companies and Associations Code); and
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c.	any service agreements<br> to be entered into with members of the executive management and other executives (as the case may be) providing for severance payments<br> exceeding twelve months’ remuneration (or, subject to a motivated opinion by the remuneration committee, eighteen months’<br> remuneration) (article 7:121, last subsection juncto article 7:92, first subsection of the Belgian Companies and<br> Associations Code).
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Notwithstanding points (a) and (b) above, our Board of Directors has been explicitly authorized in the Articles of Association to deviate from the provisions of Article 7:91 of the Belgian Companies and Associations.

Each member of the executive management is entitled to a basic fixed remuneration designed to fit responsibilities, relevant experience and competences, in line with market rates for equivalent positions. The majority of the annual remuneration is a fixed compensation amount. There is no minimum or maximum variable bonus.

The Chief Executive Officer has a fixed remuneration, a fixed bonus and variable bonus linked to the performance of the Company and to his capacity to manage remuneration costs.

The other management team members receive a fixed remuneration plus a variable bonus that is linked to their personal achievements (i.e., experience, know-how, education, skills, responsibilities, and performance) and the achievements of the Company. The remuneration is closely linked to performance.

Bonuses, if any, are linked to identifiable objectives and to special projects and are set and measured on a calendar-year basis. Non-performers are not retained in the Company. The performance objectives of the management team members are primarily evaluated with regard to the following criteria: (i) respect of the board-approved annual budget, and (ii) meeting measurable operational targets. The various objectives and their weighting may differ for the individual managers.

The Nomination and Remuneration Committee of the Board of Directors meets annually to review the performance of the executive managers, to compare the actual measurable results to the objectives that were pre-defined by the committee, and to establish the measurable objectives for the ensuing calendar year.

Each member of the executive management is in principle entitled to receive share options or subscription rights.

Each member of the executive management who is a salaried employee may be entitled to a number of fringe benefits, which may include participating in a defined contribution pension or retirement scheme, disability insurance, a company car, a mobile telephone, internet access and/or a laptop computer according to general Company policy, and other collective benefits (such as hospitalization insurance and meal vouchers). Executive members who are engaged on the basis of a services contract do not receive fringe benefits, except that they may be provided with a mobile phone and laptop computer according to general Company policy, and they qualify for reimbursement of expenses incurred while carrying out their professional responsibilities.

Executive managers of the Company that are employed under employee contracts are entitled to enroll in defined-contribution type pension plans (such as 401(k) plans in the United States). Executive managers of the Company that are engaged on the basis of a service agreement are not entitled to any pension plans or pension plan contributions from the Company.

Furthermore, the Company has entered into indemnification arrangements with the members of the executive management and has implemented directors’ and officers’ insurance coverage in order to cover liability they may incur in the exercise of their mandates.

Mr. McGarrity is remunerated on the basis of his executive management position. As CEO, Mr. McGarrity is entitled to a gross annual base salary of $535,000, which will be reviewed by the Board of Directors (or the Nomination and Remuneration Committee) on an annual basis, and an annual bonus of up to 50% of the then applicable base salary. In connection with his hiring as CEO in February 2019, Mr. McGarrity also received a one-time grant of 1,500,000 subscription rights (employee share options) and a one-time signing bonus in the gross amount of $85,000. Furthermore, Mr. McGarrity is entitled to the reimbursement of expenses, and he and his dependents are eligible to participate in all group health, medical, dental, disability and insurance plans, incentive, savings and retirement plans, and other employee benefits that are established by the Company for its executives.

Excluding the value of subscription rights (employee share options), the remuneration and benefits provided to Mr. McGarrity in 2022 were composed of the following:

	Compensation
	(in )	(in )
Fixed<br> gross remuneration^(1)^
Supplementary<br> paid compensation^(2)^ (gross)
Pension benefits
Other<br> benefits^(3)^
Total

All values are in Euros.

^(1)^	Total cost to the Company,<br> including employer social security contributions and vacation pay accrual.
^(2)^	Excludes value of 1,000,000<br> subscription rights (employee share options) already created, issued, and accepted in 2022 under the Company’s 2022 Share Option<br> Plan.
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^(3)^	Includes Company-paid and<br> other similar benefits, such as the employer’s payroll taxes, meal tickets and health insurances. Excludes reimbursement of<br> normal professional expenses such as telephone and Company travel expenses.
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The 2022 combined remuneration package of the other executive management team members in office in 2022 (excluding the CEO)—i.e., John Bellano, Joseph Sollee and Ron Kalfus—including employer taxes, was €1,190,210 composed of the following:

	Compensation
	(in )	(in )
Fixed<br> gross remuneration^(1)^
Bonuses<br> paid and awarded ^(2)^ (gross)
Pension benefits
Other<br> benefits^(3)^
Total

All values are in Euros.

^(1)^	Includes employer taxes<br> and vacation pay accrual. Excludes VAT.
^(2)^	Excludes value of subscription<br> rights (employee share options) already created, issued, and accepted in 2022 by certain other executive managers under the Company’s<br> 2022 Share Option Plan.
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^(3)^	Includes for some individuals<br> a Company car, meal vouchers, and other similar benefits. Excludes reimbursement of normal professional expenses such as telephone<br> and Company travel expenses.
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The total remuneration and benefits paid to the executive management team members (including the Chief Executive Officer) in 2022 and 2021 was €1,729,842 ($1,822,389) and €1,526,037 ($1,814,834) (gross amount, excluding VAT and share based compensation), respectively. In the aforementioned figures, the service fees of the managers hired on the basis of a service agreement are included with the salaries of the other management team members.

The primary performance objectives for the bonuses of the above management team members in 2022 were the following:

●	respect of the board-approved annual<br> budget, with a focus on cash-flow management; and
●	meeting measurable operational<br> targets, including total revenues, unit volumes for the Confirm mdx test, revenues<br>attributable to the Company’s UTI testing solution, and achievement of Medicare reimbursement for the Select mdx test.
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Each of these foregoing targets was based on minimum percentage attainment of defined, objective outcomes for the full calendar year, with the revenue, cash flow and unit volume targets tied to items that are reviewed by the Company’s independent auditors in the ordinary course. Additionally, each performance target was assigned a pre-defined weighting as a percentage of the bonus eligibility applicable to each member of executive management, with the CEO being treated consistently with other members of the executive management team.

The table below provides an overview as of December 31, 2022, of the subscription rights (employee share options) held by the members of the executive management team. The options with an expiration date of May 25, 2032 we granted in 2022.

	Options
Name	Number of<br> Ordinary Shares<br> Underlying the<br> Options	Option Exercise<br> Price per<br> Ordinary Share<br> Underlying the<br> Options<br> (in EUR)	Option<br> Expiration<br> Date
Michael K. McGarrity	1,500,000 <br>450,000 <br>1,000,000<br><br>1,000,000	1.49 <br>0.80 <br>1.375<br><br>0.684	June 18, 2027 <br>June 20, 2029 <br>May 26, 2031 <br>May 25, 2032
Ron Kalfus	200,000 <br>347,000 <br>400,000<br><br>400,000	1.24 <br>0.80 <br>1.375<br><br>0.684	June 20, 2029 <br>June 20, 2029 <br>May 26, 2031 <br>May 25, 2032
Joseph Sollee	40,000 <br>40,000 <br>40,000 <br>230,000 <br>98,000 <br>350,000<br><br>400,000	4.49 <br>3.78 <br>5.35 <br>1.24 <br>0.80 <br>1.375<br><br>0.684	June 22, 2024 <br>June 22, 2024 <br>June 22, 2024 <br>June 20, 2029 <br>June 20, 2029 <br>May 26, 2031 <br>May 25, 2032
John Bellano	400,000 <br>288,000 <br>450,000<br><br>400,000	1.24 <br>0.80 <br>1.375<br><br>0.684	June 20, 2029 <br>June 20, 2029 <br>May 26, 2031 <br>May 25, 2032

C. Board Practices

The following table sets forth certain information relating to our Board of Directors as of December 31, 2022.

Name	Age	Position(s)	Year of Initial Appointment	Current Term Expiration Year
Koen Hoffman^(1)^	54	Independent<br> Non-Executive Director (Chairperson of the Board of Directors)	2018	2024
Michael K. McGarrity	60	Executive Director (Chief<br> Executive Officer)	2019	2023^(2)^
Jan Pensaert^(3)^	51	Non-Executive Director	2014	2024
Dr. Lieve Verplancke^(4)^	63	Independent Non-Executive<br> Director	2017	2024
Hilde Windels^(5)^	57	Independent Non-Executive<br> Director	2017	2023^(2)^
Dr. Regine Slagmulder^(6)^	56	Independent Non-Executive<br> Director	2020	2023^(2)^
Dr. Eric Bednarski	51	Non-Executive Director	2020	2023^(2)^
Donnie (Don) M. Hardison	72	Independent Non-Executive<br> Director	2021	2023^(2)^
^(1)^	Acting through Ahok BV.
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^(2)^	Director is up for reelection<br> to a new mandate in May 2023 at our shareholder meeting.
^(3)^	Acting through Valiance<br> Advisors LLP.
^(4)^	Acting through Qaly-Co BV.
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^(5)^	Acting through Hilde Windels<br> BV.
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^(6)^	Acting through Regine Slagmulder<br> BV.
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Unless otherwise stated, the address for our directors is CAP Business Center, Zone Industrielle des Hauts-Sarts, Rue d’Abhooz 31, 4040 Herstal, Belgium.

Committees of our Board of Directors

Our Board of Directors is assisted by a number of specialized committees in order to advise the board in respect of decisions to be taken, to give comfort to the Board of Directors that certain issues have been adequately addressed and, if necessary, to bring specific issues to the attention of the Board of Directors. The decision-making remains the collegial responsibility of the Board of Directors.

Our Board of Directors has established, in its midst and under its responsibility, two board committees which are responsible for assisting the Board of Directors and making recommendations in specific fields: an Audit Committee (in accordance with article 7:99 of the Belgian Companies and Associations Code and provision 4.10 and following of the Belgian Corporate Governance Code) and a Remuneration and Nomination Committee (in accordance with article 7:100 of the Belgian Companies and Associations Code and provision 4.17 and following of the Belgian Corporate Governance Code). The terms of reference of these board committees are primarily set out in the Corporate Governance Charter of the Company.

Audit Committee

As of the date of this annual report, our Audit Committee consists of three directors: Regine Slagmulder, Lieve Verplancke, and Hilde Windels.

According to the Belgian Companies and Associations Code, all members of the Audit Committee must be non-executive directors, and at least one member must be independent within the meaning of article 7:87 of the Belgian Companies and Associations Code and provision 3.5 of the Belgian Corporate Governance Code. Our Board of Directors has determined that all members of our Audit Committee are independent under Rule 10A-3 of the Exchange Act, the applicable listing standards of Nasdaq, and the Belgian Companies and Associations Code and the Belgian Corporate Governance Code.

The members of the Audit Committee must have a collective expertise relating to the activities of the Company, and at least one member of the Audit Committee must have the necessary competence in accounting and auditing, including qualifying as an “audit committee financial expert” as defined under the Exchange Act. Our Board of Directors has determined that the members of the Audit Committee satisfy the competency requirement, and our Board of Directors has further determined that Regine Slagmulder and Hilde Windels each qualifies as an “audit committee financial expert” as defined under the Exchange Act.

The Audit Committee will be governed by a charter that complies with Nasdaq listing rules and the Belgian Corporate Governance Code.

Without prejudice to the legal responsibilities of the Board of Directors, the Audit Committee has the following roles:

●	to inform our Board of<br> Directors of the result of the audit of the financial statements and the manner in which the audit has contributed to the integrity<br> of the financial reporting and the role that the Audit Committee has played in that process;
●	to monitor the financial<br> reporting process, and to make recommendations or proposals to ensure the integrity of the process;
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●	to monitor the effectiveness<br> of our Company’s internal control and risk management systems, and our Company’s internal audit process and its effectiveness;
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●	to monitor the audit of<br> the annual statutory and consolidated financial statements, including the follow-up questions and recommendations by the statutory<br> auditor and, as the case may be, the auditor responsible for the audit of the consolidated financial statements;
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●	to assess and monitor the<br> independence of the statutory auditor, in particular with respect to the appropriateness of the provision of additional services<br> to the Company. More specifically, the Audit Committee analyzes, together with the statutory auditor, the threats for the statutory<br> auditor’s independence and the security measures taken to limit these threats, when the total amount of fees exceeds the criteria<br> specified in article 4 § 3 of Regulation (EU) No 537/2014; and
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●	to make recommendations<br> to our Board of Directors on the selection, appointment and remuneration of our Company’s statutory auditor in accordance with<br> article 16 § 2 of Regulation (EU) No 537/2014.
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The Audit Committee shall meet whenever it deems it necessary for the proper performance of its duties and at least four regularly scheduled meetings each year. The Audit Committee regularly reports to our Board of Directors on the exercise of its missions, and at least once a year prior to the approval of the annual financial statements and annual report by the Board of Directors on the operations, findings and recommendations of the Audit Committee. The members of the Audit Committee shall have unrestricted access to the offices and all information and papers kept by the company and its subsidiaries. Each member of the Audit Committee may ask the executive management or any other staff member of the Company or its subsidiaries to submit the information that he or she deems useful, appropriate or necessary to perform his or her tasks within the framework of the Audit Committee.

Without prejudice to the statutory provisions which determine that the statutory auditor must address reports or warnings to our corporate bodies, the statutory auditor must discuss, at the request of the statutory auditor, or at the request of the Audit Committee or of our Board of Directors, with the Audit Committee or with the Board of Directors, essential issues which are brought to light in the exercise of the statutory audit of the financial statements, which are included in the additional statement to the Audit Committee, as well as any meaningful shortcomings discovered in our internal financial control system.

Nomination and Remuneration Committee

According to article 7:100 § 4 of the Belgian Companies and Associations Code, our Company would meet the size criteria in order to operate without a separate remuneration committee, but we have chosen to continue operating with a separate Nomination and Remuneration Committee.

As of the date of this annual report, our Nomination and Remuneration Committee consists of five directors: Eric Bednarski, Don Hardison, Koen Hoffman, Jan Pensaert, and Lieve Verplancke.

In line with the Belgian Companies and Associations Code and the Belgian Corporate Governance Code (i) all members of the Nomination and Remuneration Committee are non-executive directors, (ii) the Nomination and Remuneration Committee consists of a majority of independent directors, and (iii) the Nomination and Remuneration Committee is chaired by the Chairperson of our Board of Directors or another non-executive director appointed by the committee, it being understood that the Chair of the Board of Directors should not chair the committee when dealing with the designation of his successor. Our Board of Directors has determined that three members of our Nomination and Remuneration Committee are independent under the applicable listing standards of Nasdaq, the applicable rules of the Belgian Companies and Association Code and the Belgian Corporate Governance Code.

Pursuant to the Belgian Companies and Associations Code, a remuneration committee must have the necessary expertise in terms of remuneration policy. Our Board of Directors has determined that the members of the Nomination and Remuneration Committee satisfy this requirement.

The role of the Nomination and Remuneration Committee is to make recommendations to the Board of Directors with regard to the appointment and remuneration of directors and members of the executive management and, in particular, to:

●	identify, recommend and<br> nominate, for the approval of the Board of Directors, candidates to fill vacancies in the Board of Directors and executive management<br> positions as they arise. In this respect, the Nomination and Remuneration Committee must consider and advise on proposals<br> made by relevant parties, including management and shareholders;
●	advise the Board of Directors<br> on any proposal for the appointment of the Chief Executive Officer and on the Chief Executive Officer’s proposals for the appointment<br> of other members of the executive management;
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●	draft appointment procedures<br> for members of the Board of Directors and the Chief Executive Officer;
---	---
●	ensure that the appointment<br> and re-election process is organized objectively and professionally;
---	---
●	periodically assess the<br> size and composition of the Board of Directors and make recommendations to the Board of Directors with regard to any changes;
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●	consider issues related<br> to succession planning;
---	---
●	make proposals to the Board<br> of Directors on the remuneration policy for directors and members of the executive management and the persons responsible for the<br> day-to-day management of the Company, as well as, where appropriate, on the resulting proposals to be submitted by the Board<br> of Directors to the shareholders’ meeting;
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●	make proposals to the Board<br> of Directors on the individual remuneration of directors and members of the executive management, and the persons responsible for<br> the day-to-day management of the company, including variable remuneration and long-term incentives, whether or not share-related,<br> in the form of share options or other financial instruments, and arrangements on early termination, and where applicable, on the<br> resulting proposals to be submitted by the Board of Directors to the shareholders’ meeting;
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●	prepare a remuneration<br> report to be included by the Board of Directors in the annual Corporate Governance Statement;
---	---
●	present and provide explanations<br> in relation to the remuneration report at the annual shareholders’ meeting; and
---	---
●	report regularly to the<br> Board of Directors on the exercise of its duties.
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Pursuant to the Belgian Companies and Associations Code, the Chief Executive Officer participates in the meetings of the Nomination and Remuneration Committee in an advisory capacity each time the remuneration of another member of the executive management is being discussed.

D. Employees

As of December 31, 2022, we had 258 employees, 252 of whom are employed on a full-time basis. Of these employees, 244 are located in the United States and 14 in Europe. None of our employees is covered by a collective bargaining agreement, and we believe our relationship with our employees is good.

Our human capital resources objectives include, as applicable, identifying, recruiting, retaining, incentivizing and integrating our existing and new employees, advisors and consultants. The principal purposes of our equity incentive plans are to attract, retain and reward personnel through the granting of stock-based compensation awards, in order to increase stockholder value and the success of our company by motivating such individuals to perform to the best of their abilities and achieve our objectives.

E. Share Ownership

For information regarding the share ownership of our supervisory and executive board members, see Item 6B. “Compensation” and Item 7A. “Major Shareholders.”

F. Disclosure of a registrant’s actionto recover erroneously awarded compensation

Not applicable.

ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTYTRANSACTIONS

A. Major Shareholders

Except as specifically noted, the following table sets forth information with respect to the beneficial ownership of our ordinary shares as of March 31, 2023:

●	each of our directors and<br> executive officers;
●	each person known to us<br> to beneficially own more than 3% of our ordinary shares; and
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●	all of our supervisory<br> board members and executive board members as a group.
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As of March 31, 2023, there were four record holders of our ordinary shares, none of who were residents of the United States.

All of the ordinary shares have the same voting rights and no major shareholders of the Company have different voting rights.

Beneficial ownership is determined according to the rules of the SEC and generally means that a person has beneficial ownership of a security if he, she or it possesses sole or shared voting or investment power of that security, including ordinary shares that can be acquired within 60 days of March 31, 2023. Ordinary shares subject to derivative securities currently exercisable or exercisable within 60 days of March 31, 2023 are deemed to be outstanding for computing the percentage ownership of the person holding these securities and the percentage ownership of any group of which the holder is a member, but are not deemed outstanding for computing the percentage of any other person.

The percentage ownership information shown in the table is based upon 270,380,936 ordinary shares outstanding as of March 31, 2023.

Except as indicated by the footnotes below, we believe, based on the information furnished to us, that the persons named in the table below have sole voting and investment power with respect to all ordinary shares shown that they beneficially own, subject to community property laws where applicable. The information does not necessarily indicate beneficial ownership for any other purpose, including for purposes of Sections 13(d) and 13(g) of the Exchange Act.

Except as otherwise indicated in the table below, addresses of the directors, members of the executive management team and named beneficial owners are in care of MDxHealth SA, CAP Business Center, Zone Industrielle des Hauts-Sarts, Rue d’Abhooz 31, 4040 Herstal, Belgium.

Name of beneficial owner	Number of<br> Ordinary Shares Beneficially<br> Owned
3% or Greater Shareholders:
MVM Partners LLP^(1)^		45,504,584	16.8	%
Bleichroeder LP^(2)^		38,783,330	14.3	%
Valiance Asset Management Limited^(3)^		20,931,094	7.7	%
Biovest NV^(4)^		11,923,587	4.4	%
Executive Officers and Directors:
Michael K. McGarrity^(5)^		2,402,082	*
Ron Kalfus^(5)^		666,623	*
Joseph Sollee^(5)^		635,999	*
John Bellano^(5)^		833,166	*
Koen Hoffman (acting through Ahok BV)^(5)^		30,000	*
Jan Pensaert (acting through Valiance Advisors LLP)^(5)^		84,000	*
Dr. Lieve Verplancke (acting through Qaly-Co BV)^(5)^		30,000
Hilde Windels (acting through Hilde Windels BV)^(5)^		20,000	*
Dr. Regine Slagmulder (acting through Regine Slagmulder BV)		590,204	*
Dr. Eric Bednarski		—	*
Donnie (Don) M. Hardison		—	*
All current directors and executive management as a group (11 persons)		5,292,074	1.9	%
*	Less than one percent.
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^(1)^	Includes 44,585,295 shares<br> held by MVM V LP and 919,289 shares held by MVM GP (No. 5) (collectively, the “MVM Entities”). The Company has been informed<br> that voting and investment power over the shares held by the MVM Entities is exercised jointly by three or more natural persons and<br> voting and disposition decisions require the approval of a majority of such persons. Accordingly, no single natural person has voting<br> or dispositive power over such shares. The MVM Entities are party to the MVM Subscription Agreement, providing for certain rights<br> to appoint a member of our Board of Directors. See Item 7B. “Related party transactions — MVM Subscription Agreement.”<br> This information has been obtained from Schedule 13D/A filed by the MVM Entities with the SEC on February 28, 2023.
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^(2)^	Includes 20,342,162 shares<br> held by 21 April Fund Ltd., a Cayman Islands company for which Bleichroeder LP acts as investment adviser. This information has been<br> obtained from Schedule 13G/A filed by Bleichroeder Entities with the SEC on February 14, 2023.
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^(3)^	Includes 12,339,297 shares<br> held by TopMDx Ltd. and 8,591,797 shares held by Valiance Life Sciences Growth Investments SICAV-SIF (collectively, the “Valiance Entities”).<br> The Company has been informed that voting and investment power over the shares held by the Valiance Entities is exercised jointly<br> by three or more natural persons and voting and disposition decisions require the approval of a majority of such persons. Accordingly,<br> no single natural person has voting or dispositive power over such shares. This information has been obtained from Schedule 13D/A<br> filed by the Valiance Entities with the SEC on April 14, 2023.
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^(4)^	Consists of shares held<br> by Biovest NV (“Biovest”). RMM, S.A. (“RMM” and together with Biovest, the “Biovest Entities”)<br> is the sole owner of Biovest and pursuant to an understanding with Biovest, decisions relating to the voting and dispositive power<br> of the shares are shared between Biovest and the RMM’s Board of Directors (the “RMM Board”). Voting and investment<br> power over the shares managed by the RMM Board is exercised jointly by more than three natural persons and voting and disposition<br> decisions require the approval of a majority of such persons. Accordingly, no single natural person has a controlling decision and<br> no individual director of the RMM should be deemed to be a beneficial owner of the shares. This information has been obtained from<br> Schedule 13G/A filed by the Biovest Entities with the SEC on March 17, 2023.
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^(5)^	Reflects shares acquirable<br> upon the exercise of warrants, which are described above in Item 6.B. “Compensation.”
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From December 31, 2019 to December 31, 2022, the only significant changes related to the beneficial owners listed in the above table of which we have been notified of through Shareholder Transparency Declarations in accordance with Article 14 of the Belgian Act of May 2, 2007 on the disclosure of important participations in issuers of which shares are admitted to trading on a regulated market and regarding miscellaneous provisions (the “Declarations” and each a “Declaration”) are listed below:

●	November 22, 2021 Declaration: MDxHealth<br> was notified that the number of shares with respect to which Bleichroeder LP can exercise<br> voting rights actively crossed above the threshold of 15% of the outstanding shares and voting<br> rights of MDxHealth on November 19, 2021.
●	November 15, 2021 Declaration: MDxHealth<br> was notified that the number of shares with respect to which Bleichroeder LP can exercise<br> voting rights actively crossed above the threshold of 10% of the outstanding shares and voting<br> rights of MDxHealth on November 4, 2021.
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●	February 3, 2021 Declaration: Biovest<br> NV notified MDxHealth that the number of shares with respect to which Biovest NV can exercise<br> voting rights passively crossed below the threshold of 10% of the outstanding shares and<br> voting rights of MDxHealth on January 26, 2021.
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●	May 25, 2020 Declaration: Valiance<br> Asset Management Limited notified MDxHealth that the aggregate number of shares with respect<br> to which Valiance Asset Management Limited can exercise voting rights passively crossed below<br> the threshold of 15% of the outstanding shares and voting rights of MDxHealth. MVM Partners<br> LLP notified MDxHealth that the aggregate number of shares with respect to which MVM Partners<br> LLP can exercise voting rights actively crossed above the threshold of 20% of the outstanding<br> shares and voting rights of MDxHealth.
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B. Related Party Transactions

Agreements with the Members of the Board ofDirectors and the Executive Management

Each non-executive director exercises his/her mandate as a self-employed worker. According to our Articles of Association, the term of a directors’ mandate cannot exceed four years, but may be renewed. The directors’ mandates may be terminated ad nutum (at any time) without any form of compensation. There is no specific agreement between us and non-executive directors which waives or restrains this right of the Company to terminate ad nutum (at any time) the mandates of the directors.

Currently, all the members of the executive management are engaged on the basis of an employment agreement. The employment agreements are for an indefinite term. The employment agreements include, where appropriate, non-competition undertakings, as well as confidentiality and intellectual property transfer undertakings (which are intended to obtain maximum protection of our interests, under applicable laws and subject to the employee’s agreement).

●	We hired Mr. Michael K.<br> McGarrity, acting in the role of Chief Executive Officer, effective as of February 18, 2019. The executive employment agreement with<br> Mr. McGarrity provides that if we terminate the employment agreement without cause or if Mr. McGarrity resigns for good reason, Mr.<br> McGarrity shall be eligible to receive as severance an amount equal to twelve months of base salary in effect at the time of the<br> separation. In addition, we have the right, exercisable at any time, to terminate the executive employment agreement with immediate<br> effect for cause (as defined in the employment agreement) by providing written notice.
●	Acting under the direction<br> of the Board of Directors, we hired Mr. Ron Kalfus, acting in the role of Chief Financial Officer, effective as of July 22,<br> 2019. The executive employment agreement with Mr. Kalfus provides that if we terminate the employment agreement without cause<br> or if Mr. Kalfus resigns for good reason, Mr. Kalfus shall be eligible to receive as severance an amount equal to six months<br> of base salary in effect at the time of the separation, which amount will increase to twelve months of base salary for a termination<br> that occurs after July 22, 2020. In addition, we have has the right, exercisable at any time, to terminate the executive employment<br> agreement with immediate effect for cause (as defined in the employment agreement) by providing written notice.
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●	Acting under the direction<br> of the Board of Directors, we hired Mr. John Bellano, acting in the role of Chief Commercial Officer, effective as of June 19,<br> 2019. The executive employment agreement with Mr. Bellano provides that if we terminate the employment agreement without cause<br> or if Mr. Bellano resigns for good reason, Mr. Bellano shall be eligible to receive as severance an amount equal to six<br> months of base salary in effect at the time of the separation, which amount will increase to twelve months of base salary for a termination<br> that occurs after June 19, 2020. In addition, we have the right, exercisable at any time, to terminate the executive employment<br> agreement with immediate effect for cause (as defined in the employment agreement) by providing written notice.
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●	The executive employment<br> contract with Mr. Joe Sollee dates from before the entry into force of the Belgian Act of April 6, 2010 on corporate governance<br> in public and listed companies and is in conformity with common employment law. The contract with Mr. Sollee provides that if<br> his employment is terminated for a reason other than serious misconduct or if Mr. Sollee resigns for good reason, he will be<br> entitled to severance pay of nine months gross remuneration and benefits. In addition, we have the right, exercisable at any time,<br> to terminate the executive employment agreement with immediate effect for cause (as defined in the employment agreement) by providing<br> written notice.
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Options Granted to Our Board Directors andExecutive Management

We have granted subscription rights, or options, to certain members of our Board of Directors and executive management. For more information regarding the options granted to our Board of Directors and executive management. See Item 6B. “Compensation.”

MVM Subscription Agreement

As part of an investment by MVM V LP and MVM GP (No. 5) LP, or collectively MVM, into our share capital, our company entered in April 2020 into a subscription agreement with MVM, or the Subscription Agreement. Pursuant to the Subscription Agreement, MVM is entitled to have one observer at the Board of Directors of our Company for as long as MVM holds in aggregate 5% of our company’s outstanding shares. At the date of this annual report, the observer of MVM at our Board of Directors is Dr. Kyle Dempsey. In addition, we agreed that MVM could propose to our 2020 general shareholders’ meeting to appoint Dr. Eric Bednarski as director of the Company. Our general shareholders’ meeting held on July 30, 2020 approved the appointment of Dr. Eric Bednarski as a director for a term of three years, up to and including the closing of our annual general shareholders’ meeting to be held on May 25, 2023.

Offering Purchases

Pursuant to our February 2023 follow-on public offering of ADSs in the United States, (1) the Bleichroeder Entities (as defined above under “A. Major Shareholders”) purchased 1,500,000 ADSs representing 15,000,000 ordinary shares for an aggregate purchase price of $6,000,000, (2) the MVM Entities (as defined above under “A. Major Shareholders”) purchased 1,000,000 ADSs representing 10,000,000 ordinary shares for an aggregate purchase price of $4,000,000, and (3) the Valiance Entities (as defined above under “A. Major Shareholders”) acquired and 190,408 ADSs representing 1,904,080 ordinary shares for an aggregate purchase price of $761,632.

C. Interests of Experts and Counsel

Not applicable.

ITEM 8. FINANCIAL INFORMATION

A. Consolidated Statements and Other FinancialInformation

Consolidated Financial Statements

Our audited consolidated financial statements are appended at the end of this annual report starting at page F-1, and form a part hereof.

Legal Proceedings

We are not a party to any pending material legal proceedings.

We signed a sale and purchase agreement on September 18, 2015 (the “Purchase Agreement”) pursuant to which we acquired all shares and voting interests of NovioGendix, an entity incorporated in The Netherlands. Under the terms of the Purchase Agreement, in addition to the consideration paid at closing, we committed to pay up to $3.3 million to the prior owners of NovioGendix (the “Sellers”) subject to meeting certain milestones, payable in six milestone payments. As of December 31, 2021, we had made $1.1 million of these milestone payments. As of December 31, 2021, we recorded $1.6 million of contingent liabilities related to this contingent consideration. In June 2021, we received a notice of dispute from the Sellers claiming that approximately $880,000 of the remaining $2.2 million of milestone payments had been earned and we were in breach of the Purchase Agreement for not having timely paid such milestone payments to the Sellers. In September 2021, pursuant to the Purchase Agreement, representatives of the Company met with representatives of the Sellers to discuss these matters. During this meeting the Company’s representatives informed the representatives of the Seller that the Company disagrees with the Sellers that any such payments have been earned and are payable by the Company. Following this meeting, the Sellers requested further information from the Company and indicated if these matters are not resolved to Sellers’ satisfaction, they may take further action to enforce their rights by instituting arbitration proceedings, in accordance with the terms of the Purchase Agreement, before the Netherlands Arbitration Institute.

Dividend Policy

We have never declared or paid any cash dividends on our ordinary shares. We do not anticipate paying cash dividends on our equity securities in the foreseeable future and intend to retain all available funds and any future earnings for use in the operation and expansion of our business. All of the ordinary shares offered by this annual report will have the same dividend rights as all of our other outstanding ordinary shares. In general, distributions of dividends proposed by our Board of Directors require the approval of our shareholders at a meeting of shareholders with a simple majority vote, although our Board of Directors may declare interim dividends without shareholder approval, subject to the terms and conditions of the Belgian Code of Companies and Associations, or CCA. See Item 10B. “Memorandum and Articles of Association.”

Our ability to distribute dividends is subject to availability of sufficient distributable profits as defined under Belgian law on the basis of our stand-alone statutory accounts prepared in accordance with Belgian GAAP. In particular, dividends can only be distributed if following the declaration and issuance of the dividends the amount of our net assets on the date of the closing of the last financial year as follows from the statutory non-consolidated financial statements (i.e., summarized, the amount of the assets as shown in the balance sheet, decreased with provisions and liabilities, all in accordance with Belgian accounting rules), and, save in exceptional cases, to be mentioned and justified in the notes to the annual accounts, decreased with the non-amortized costs of incorporation and extension and the non-amortized costs for research and development, does not fall below the amount of the paid-up capital (or, if higher, the issued capital), increased with the amount of non-distributable reserves (which include, as the case may be, the unamortized part of any revaluation surpluses).

In addition, pursuant to Belgian law and our Articles of Association, we must allocate an amount of 5% of our Belgian GAAP annual net profit to a legal reserve in its stand-alone statutory accounts, until the legal reserve amounts to 10% of our share capital. Our legal reserve currently does not meet this requirement nor will it meet the requirement at the time of the closing. Accordingly, 5% of our Belgian GAAP annual net profit during future years will need to be allocated to the legal reserve, further limiting our ability to pay out dividends to its shareholders.

For information regarding the Belgian withholding tax applicable to dividends and related U.S. reimbursement procedures, see Item 9E. “Taxation — Material Belgian Tax Consequences.”

B. Significant Changes

None.

ITEM 9. THE OFFER AND LISTING

A. Offer and Listing Details

Our ADSs have been listed on Nasdaq Capital Market under the symbol “MDXH” since November 4, 2021. Prior to that date, there was no public trading market for out ADSs. Our ordinary shares have been trading on the regulated market of Euronext in Brussels under the symbol “MDXH” since June 2006. Prior to that date, there was no public trading market for our ADSs or our ordinary shares. No significant trading suspensions have occurred in the prior three years.

B. Plan of Distribution

Not applicable.

C. Markets

For information regarding the stock exchanges and regulated markets on which our ADSs and ordinary share are listed, see Item 9A. “Offer and Listing Details.”

D. Selling Shareholders

Not applicable.

E. Dilution

Not applicable.

F. Expenses of the Issuer

Not applicable.

ITEM 10. ADDITIONAL INFORMATION

A. Share Capital

Not applicable.

B. Memorandum and Articles of Association

The information set forth in the final prospectus dated November 3, 2021 as part of our Registration Statement on Form F-1 (File No. 333-260213), declared effective by the SEC on November 3, 2021, under the headings “Description of Share Capital and Articles of Association — Articles ofAssociation and Other Share Information” is incorporated herein by reference.

C. Material Contracts

For information on our material contracts entered into during the two years immediately preceding the date of the filing of this annual report, please refer to Item 4B. Business Overview” and Item 7B. “Related Party Transactions” of this annual report.

D. Exchange Controls

There are no Belgian exchange control regulations that impose limitations on our ability to make, or the amount of, cash payments to residents of the United States.

We are in principle under an obligation to report to the National Bank of Belgium certain cross-border payments, transfers of funds, investments and other transactions in accordance with applicable balance-of-payments statistical reporting obligations. Where a cross-border transaction is carried out by a Belgian credit institution on our behalf, the credit institution will in certain circumstances be responsible for the reporting obligations.

E. Taxation

The discussion below is for general information only and is not, and should not be interpreted to be, tax advice to any holder of the ADSs. Each holder or prospective holder of the ADSs is urged to consult his, her or its own tax advisor.

Material U.S. Federal Income Tax Consequences

General

The following is a discussion of the material U.S. federal income tax consequences to U.S. Holders and Non-U.S. Holders, both as defined below, of the ownership and disposition of the ADSs as of the date of this report. This discussion is based on the provisions of the Internal Revenue Code of 1986, as amended, or the “Code,” the applicable U.S. Treasury regulations promulgated and proposed thereunder, judicial decisions and current administrative rulings and guidance, all of which are subject to change, possibly on a retroactive basis. This discussion applies to you only if you acquire the ADSs and hold such ADSs as a capital asset within the meaning of Section 1221 of the Code (generally, held for investment). The U.S. Internal Revenue Service, or the “IRS,” may challenge the tax consequences described below, and we have not requested, nor will we request, a ruling from the IRS or an opinion of counsel with respect to the U.S. federal income tax consequences of acquiring, holding or disposing of the ADSs. This discussion does not purport to deal with all aspects of U.S. federal income taxation that may be relevant to the ownership of the ADSs. In particular, the discussion does not address tax consequences that depend upon an investor’s particular tax circumstances nor does it cover any state, local or foreign law, the possible application of the U.S. federal estate or gift tax laws. You are urged to consult your own tax advisor regarding the application of the U.S. federal income tax laws to your particular situation as well as any state, local, foreign and U.S. federal estate and gift tax consequences resulting from the ownership and disposition of the ADSs. In addition, this discussion does not take into account special U.S. federal income tax rules that apply to particular categories of holders of the ADSs, including, without limitation, the following:

●	dealers, brokers or traders<br> in securities electing to use a mark-to-market method of accounting;
●	banks, thrifts or other<br> financial institutions;
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●	individual retirement or<br> tax-deferred accounts;
●	insurance companies;
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●	tax-exempt organizations;
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●	regulated investment companies<br> or real estate investment trusts;
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●	persons holding the ADSs<br> as part of a hedging, straddle or conversion transaction for U.S. federal income tax purposes;
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●	persons required for U.S.<br> federal income tax purposes to conform the timing of income accruals to their financial statements under Section 451 of the<br> Code;
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●	persons whose functional<br> currency for U. S. federal income tax purposes is not the U.S. dollar;
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●	persons subject to the<br> alternative minimum tax;
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●	persons that own, or are<br> treated as owning, 10% or more, by voting power or value, of our outstanding common stock (including common stock represented by<br> ADSs);
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●	certain former U.S. citizens<br> and residents who have expatriated; or
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●	persons receiving the ADSs<br> pursuant to the exercise of employee stock options or otherwise as compensation.
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U.S. Holders

For purposes of the discussion below, you are a “U.S. Holder” if you are a beneficial owner of the ADSs that is:

●	an individual United States<br> citizen or resident alien of the United States (as specifically defined for United States federal income tax purposes);
●	a corporation, or other<br> entity treated as a corporation for U.S. federal income tax purposes, created or organized in or under the laws of the United States,<br> any state thereof or the District of Columbia;
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●	an estate whose income<br> is subject to United States federal income tax regardless of its source; or
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●	a trust (x) if a U.S. court<br> can exercise primary supervision over the trust’s administration and one or more U.S. persons are authorized to control all<br> substantial decisions of the trust or (y) that, if it was in existence on August 20, 1996, was treated as a U.S. person<br> prior to that date and has a valid election in effect under applicable United States Treasury regulations to be treated as a U.S. person.
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If a partnership (including any entity or arrangement treated as a partnership for U.S. federal income tax purposes) holds the ADSs, the tax treatment of a partner in such partnership will generally depend upon the status of the partner and upon the activities of the partnership. If you are a partnership holding the ADSs or a partner in such partnership, you should consult your tax advisor with respect to the U.S. federal income tax consequences of the ownership and disposition of the ADSs by the partnership.

General

In general, a U.S. Holder of the ADSs will be treated as owning the underlying shares represented by those ADSs for U.S. federal income tax purposes. Accordingly, no gain or loss will be recognized if a U.S. Holder exchanges ADSs for the underlying shares represented by those ADSs. The U.S. Department of the Treasury has expressed concern that parties to whom ADSs are released before shares are delivered to the Depositary (“pre-release”), or intermediaries in the chain of ownership between holders and the issuer of the security underlying the ADSs, may be taking actions that are inconsistent with the claiming of foreign tax credits by holders of ADSs. These actions would also be inconsistent with the claiming of the preferential rate of tax, described below, applicable to dividends received by certain non-corporate U.S. Holders. Accordingly, the creditability of Belgian taxes, and the availability of the preferential tax rate for dividends received by certain non-corporate U.S. Holders, each as described below, could be affected by actions taken by such parties or intermediaries.

Distributions

Subject to the “passive foreign investment company”, or PFIC, rules discussed below, the amount of any cash distribution (other than in liquidation) that you receive with respect to the ADSs including the amount of any Belgian taxes actually withheld therefrom (described below in “— MaterialBelgian Tax Consequences”) generally will be taxed to a U.S. Holder as dividend income to the extent such distribution does not exceed our current or accumulated earnings and profits, or E&P, as calculated for U.S. federal income tax purposes. Such income will be includable in your gross income as ordinary income on the date of receipt by the Depositary. Dividends received by individuals and certain other non-corporate U.S. Holders from “qualified foreign corporations” are taxed at the rate of either 0 percent, 15 percent or 20 percent, depending upon the particular taxpayer’s U.S. federal income tax bracket; provided that the recipient-shareholder has held his or her shares as a beneficial owner for more than 60 days during the 121-day period beginning on the date which is 60 days before the shares’ ex-dividend date. A foreign corporation is a “qualified foreign corporation” if the stock with respect to which it pays dividends is traded on an established securities market in the United States, provided that the foreign corporation is not a PFIC.

The ADSs are traded on an established securities market in the United States, although we cannot guarantee that the ADSs will be so traded in the future. If we are not a PFIC and we are treated as a qualified foreign corporation, dividends we pay with respect to the ADSs would be eligible for the reduced rates of taxation described in this paragraph. We do not expect to be treated as a PFIC for our current taxable year. However, our PFIC status for any taxable year is an annual determination that can be made only after the end of that year and will depend on the composition of our income and assets and the value of our assets from time to time. No assurance can be given that the IRS will not disagree and seek to treat us as a PFIC. If we are a PFIC with respect to a particular U.S. Holder, dividends received from us would be taxed at regular ordinary income tax rates and certain other rules will apply. See “Passive Foreign Investment Company (PFIC),” below. Holders of Company ADSs should consult their own tax advisors regarding the availability of a reduced dividend tax rate in light of their own particular circumstances.

To the extent any distribution exceeds our E&P, the distribution will first be treated as a tax-free return of capital to the extent of your adjusted tax basis in the ADSs and will be applied against and reduce such basis on a dollar-for-dollar basis (thereby increasing the amount of gain and decreasing the amount of loss recognized on a subsequent disposition of such ADSs). To the extent that such distribution exceeds your adjusted tax basis, the distribution will be taxed as gain recognized on a sale or exchange of ADSs. However, because we do not maintain calculations of our E&P under U.S. federal income tax principles, it is expected that distributions will generally be reported to U.S. Holders as dividends. Because we are not a U.S. corporation, no dividends-received deduction will be allowed to corporations with respect to dividends paid by us.

For U.S. foreign tax credit limitation purposes, dividends received on ADSs will be treated as foreign source income and will generally constitute “passive category income,” or in the case of certain holders, “general category income.” You may be eligible, subject to a number of complex limitations, to claim a foreign tax credit in respect of Belgian taxes actually withheld on dividends paid on ADSs. A U.S. Holder who does not elect to claim a foreign tax credit for foreign tax withheld may instead claim a deduction, for U.S. federal income tax purposes, in respect of such withholding, but only for a year in which such U.S. Holder elects to do so for all creditable foreign income taxes. However, if we are a “U.S.-owned foreign corporation,” solely for foreign tax credit purposes, a portion of the dividends allocable to our U.S. source earnings and profits may be re-characterized as U.S. source. A “U.S.-owned foreign corporation” is any foreign corporation in which U.S. persons own, directly or indirectly, 50% or more (by vote or by value) of the stock. In general, U.S.-owned foreign corporations with less than 10% of earnings and profits attributable to sources within the United States are excepted from these rules. Although we don’t believe we are currently a “U.S.-owned foreign corporation,” we may become one in the future. In such case, if 10% or more of our earnings and profits are attributable to sources within the United States, a portion of the dividends paid on the ADSs allocable to our U.S. source earnings and profits will be treated as U.S. source, and, as such, a U.S. Holder may not offset any foreign tax withheld as a credit against U.S. federal income tax imposed on that portion of dividends. The rules governing U.S. foreign tax credits are complex, and we recommend that you consult your tax advisor regarding the applicability of such rules to you.

Sale, Exchange or OtherDisposition of ADSs

Subject to the PFIC rules discussed below, generally, in connection with the sale, exchange or other disposition of ADSs:

●	you will recognize capital<br> gain or loss equal to the difference (if any) between the amount realized on such sale, exchange or other disposition and your adjusted<br> tax basis in such ADSs;
●	such gain or loss will<br> be long-term capital gain or loss if your holding period for such ADSs is more than one year at the time of the sale or other<br> disposition;
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●	such gain or loss will<br> generally be treated as U.S. source for U.S. foreign tax credit purposes; and
●	your ability to deduct<br> capital losses is subject to limitations.
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Long-term capital gains recognized by individuals and certain other non-corporate taxpayers are taxed at preferential rates. If the consideration received upon the sale or other taxable disposition of ADSs is paid in foreign currency, the amount realized will be the U.S. dollar value of the payment received, translated at the spot rate of exchange on the date of taxable disposition. If ADSs are treated as traded on an established securities market, a cash basis U.S. Holder and an accrual basis U.S. Holder who has made a special election (which must be applied consistently from year to year and cannot be changed without the consent of the IRS) will determine U.S. dollar value of the amount realized in foreign currency by translating the amount received at the spot rate of exchange on the settlement date of the sale. An accrual basis United States Holder that does not make the special election will recognize exchange gain or loss to the extent attributable to the difference between the exchange rates on the sale date and the settlement date, and such exchange gain or loss generally will constitute ordinary income or loss.

Passive Foreign InvestmentCompany (PFIC)

Based on the current estimates, and expected future composition, of our income and the value of our assets, including goodwill, we do not expect to be a PFIC for our current taxable year. However, our PFIC status for any taxable year is an annual determination that can be made only after the end of that year and will depend on the composition of our income and assets and the value of our assets from time to time. The determination of whether we are a PFIC is fact-intensive and the applicable law is subject to varying interpretation. There can be no assurance that the IRS will agree with our position or that the IRS will not successfully challenge our position including our classification of certain income and assets as non-passive or our valuation of our tangible and intangible assets.

If we are treated as a PFIC, gain realized on the sale, exchange or other disposition of your ADSs would in general not be treated as capital gain. Instead, such gain would be allocated ratably over your holding period for the ADSs. The amounts allocated to the taxable year of the sale, exchange or other disposition and to any year before we became a PFIC would be taxed as ordinary income. The amount allocated to each other taxable year would be subject to tax at the highest rate in effect for such year, together with an interest charge on the tax attributable to each such year. If we are a PFIC for any year during a U.S. Holder’s holding period for ADSs, we generally will continue to be treated as a PFIC with respect to such U.S. Holder for all succeeding years during which such U.S. Holder owns the ADSs. Dividends received from ADSs will not be eligible for the special tax rates applicable to qualified dividend income for certain non-corporate U.S. Holder if we were treated as a PFIC with respect to the U.S. Holder, either in the taxable year of the distribution or the preceding taxable year, but instead will be taxable at rates applicable to ordinary income. Further, any distribution in respect of ADSs in excess of 125 percent of the average annual distributions on ADSs received by a U.S. Holder during the preceding three years or such U.S. Holder’s holding period, whichever is shorter, would be allocated ratably over the U.S. Holder’s holding period for ADSs and subject to taxation as described with respect to sales, exchanges or other dispositions above. Certain elections may be available that would result in alternative treatments such as mark-to-market treatment of the ADSs.

3.8% Medicare Tax on“Net Investment Income”

Certain U.S. Holders that are individuals, estates, and certain trusts are subject to a 3.8% tax on all or a portion of their “net investment income,” which may include any gain realized or amounts received with respect to their ADSs, to the extent of their net investment income that, when added to other modified adjusted gross income, exceeds $200,000 for a single taxpayer (or a qualifying head of household), $250,000 for married taxpayers filing a joint return (or a qualifying widower), or $125,000 for a married taxpayer filing a separate return. U.S. Holders should consult their own tax advisors with respect to the applicability of the net investment income tax.

Information Reportingand Backup Withholding

Except in the case of corporations or other exempt holders, amounts received by a U.S. Holder in connection with distributions, if any, paid by Company with respect to ADSs and proceeds from the sale, exchange or other disposition of ADSs may be subject to U.S. information reporting requirements and backup withholding unless the U.S. Holder provides an accurate taxpayer identification number and complies with certain certification procedures or otherwise establishes an exemption from backup withholding. Backup withholding is not an additional tax and amounts withheld may be allowed as a credit against the U.S. Holder’s U.S. federal income tax liability and may entitle the U.S. Holder to a refund, provided that certain required information is timely furnished to the IRS.

U.S. Holders who are individuals (and under proposed regulations, certain entities) and who own “specified foreign financial assets” with an aggregate value in excess of $50,000 on the last day of the tax year (or more than $75,000 at any time during the tax year) are generally required to file an information statement along with their tax returns, currently on IRS Form 8938, with respect to such assets, subject to certain exceptions (including an exception for shares held in custodial accounts maintained with a U.S. financial institution) “Specified foreign financial assets” include securities issued by a non-U.S. issuer (which would include ADSs) that are not held in accounts maintained by financial institutions. Higher reporting thresholds apply to certain individuals living abroad and to certain married individuals. Individuals who fail to report the required information could be subject to substantial penalties, and such individuals should consult their own tax advisors concerning the application of these rules to their investment in ADSs.

TAX MATTERS CAN BE COMPLICATED. THE FOREGOING DISCUSSION OF MATERIAL U.S. FEDERAL INCOME TAX CONSEQUENCES IS NOT INTENDED TO BE A COMPLETE ANALYSIS OR DESCRIPTION OF ALL U.S. FEDERAL INCOME TAX CONSEQUENCES OF THE OWNERSHIP AND DISPOSITION OF ADSS. IN ADDITION, THE DISCUSSION DOES NOT ADDRESS TAX CONSEQUENCES THAT DEPEND UPON INDIVIDUAL CIRCUMSTANCES. THIS DISCUSSION DOES NOT ADDRESS ANY U.S. FEDERAL TAX CONSEQUENCES OTHER THAN INCOME TAX OR ANY FOREIGN, STATE OR LOCAL TAX CONSIDERATIONS, NOR ANY TAX CONSEQUENCES OF ANY TRANSACTION OTHER THAN THE OWNERSHIP AND DISPOSITION OF ADSS. ACCORDINGLY, YOU ARE STRONGLY URGED TO CONSULT YOUR OWN TAX ADVISOR TO DETERMINE THE PARTICULAR U.S. FEDERAL, STATE, LOCAL, OR FOREIGN INCOME OR OTHER TAX CONSEQUENCES OF THE OWNERSHIP AND DISPOSITION OF ADSS TO YOU.

Non-United States Holders

For purposes of this discussion, if you are not a U.S. Holder (as defined above), you are a “Non-U.S. Holder”.

Distributions on theADSs

You generally will not be subject to U.S. federal income tax or withholding on distributions made on the ADSs unless:

●	you conduct a trade or<br> business in the U.S., and
●	the distributions are effectively<br> connected with the conduct of that trade or business (or, under certain income tax treaties, such distributions are attributable<br> to a permanent establishment that you maintain in the United States).
---	---

If you meet the two tests above, you generally will be subject to tax in respect of such distributions in the same manner as a U.S. Holder, as described above. In addition, any effectively connected distributions received by a non-U.S. corporation may also, under certain circumstances, be subject to an additional “branch profits tax” at a 30-percent rate or such lower rate as may be provided by an applicable income tax treaty.

Sale, Exchange or OtherDisposition of the ADSs

Generally, you will not be subject to U.S. federal income tax or withholding in respect of gain recognized on a sale, exchange or other disposition of the ADSs unless:

●	your gain is effectively<br> connected with a trade or business that you conduct in the United States (or, under certain income tax treaties, such gain is attributable<br> to a permanent establishment that you maintain in the United States), or
●	you are an individual Non-U.S.<br> Holder and are present in the United States for at least 183 days in the taxable year of the sale, exchange or other disposition,<br> and certain other conditions exist.
---	---

If you meet either of the two tests above, you will be subject to tax in respect of any gain effectively connected with your conduct of a trade or business in the United States generally in the same manner as a U.S. Holder, as described above. Effectively connected gains realized by a non-U.S. corporation may also, under certain circumstances, be subject to an additional “branch profits tax” at a rate of 30-percent or such lower rate as may be provided by an applicable income tax treaty.

Backup Withholdingand Information Reporting

Payments, including distributions and proceeds from sales, exchanges or other dispositions in respect of the ADSs that are made in the United States or by a U.S.-related financial intermediary will be subject to U.S. information reporting rules. In addition, such payments may be subject to U.S. federal backup withholding. You will not be subject to backup withholding provided that:

●	you are a corporation or<br> other exempt recipient, or
●	you provide your correct<br> U.S. federal taxpayer identification number and certify, under penalties of perjury, that you are not subject to backup withholding.
---	---

Amounts withheld under the backup withholding rules may be credited against your U.S. federal income tax, and you may obtain a refund of any excess amounts withheld under the backup withholding rules by filing the appropriate claim for refund with the IRS in a timely manner.

FATCA

The Foreign Account Tax Compliance Act (or “FATCA”) generally imposes a U.S. federal withholding tax of 30% on dividends on the ADSs paid to a “foreign financial institution” (as specially defined under these rules), unless such institution enters into an agreement with the U.S. government to withhold on certain payments and to collect and provide to the U.S. tax authorities substantial information regarding the U.S. account holders of such institution (which includes certain equity and debt holders of such institution, as well as certain account holders that are foreign entities with U.S. owners) or otherwise establishes an exemption. FATCA also generally imposes a U.S. federal withholding tax of 30% on dividends on the ADSs paid to a ”non-financial foreign entity” (as specially defined under these rules) unless such entity provides the withholding agent with a certification identifying certain substantial direct and indirect U.S. owners of the entity, certifies that there are none or otherwise establishes an exemption. The withholding obligations under FATCA generally apply to payments of dividends (including constructive dividends) on the ADSs. Under certain circumstances, a Non-U.S. Holder might be eligible for refunds or credits of such taxes. An intergovernmental agreement between the United States and an applicable foreign country may modify the requirements described in this paragraph.

Additionally, FATCA may impose a 30% withholding tax on payments of gross proceeds from the sale, exchange or redemption of property that gives rise to U.S.-source dividends or interest, including the ADSs. The IRS recently issued Proposed Treasury Regulations that eliminate withholding on payments of gross proceeds. Pursuant to the Proposed Treasury Regulations, the issuer and any withholding agent may (but are not required to) rely on this proposed change to FATCA withholding until the final regulations are issued. Non-U.S. Holders are encouraged to consult with their own tax advisors regarding the possible application of FATCA to their ownership of the ADSs.

Material Belgian Tax Consequences

General

The following paragraphs are a summary of material Belgian tax consequences of the ownership of ADSs by an investor. The summary is based on laws, treaties and regulatory interpretations in effect in Belgium on the date of this document, all of which are subject to change, including changes that could have retroactive effect.

The summary only discusses Belgian tax aspects which are relevant to U.S. holders of ADSs (“Holders”). This summary does not address Belgian tax aspects which are relevant to persons who are residents in Belgium or engaged in a trade or business in Belgium through a permanent establishment or a fixed base in Belgium. This summary does not purport to be a description of all of the tax consequences of the ownership of ADSs and does not take into account the specific circumstances of any particular investor, some of which may be subject to special rules, or the tax laws of any country other than Belgium. This summary does not describe the tax treatment of investors that are subject to special rules, such as banks, insurance companies, collective investment undertakings, dealers in securities or currencies, persons that hold, or will hold, ADSs in a position in a straddle, share-repurchase transaction, conversion transactions, synthetic security or other integrated financial transactions. Investors should consult their own advisers regarding the tax consequences of an investment in ADSs in the light of their particular circumstances, including the effect of any state, local or other national laws, treaties and regulatory interpretation thereof.

In addition to the assumptions mentioned above, it is also assumed in this discussion that for purposes of the domestic Belgian tax legislation, the owners of ADSs will be treated as the owners of the ordinary shares represented by such ADSs. However, the assumption has not been confirmed by or verified with the Belgian Tax Administration.

For the purposes of this summary, ADSs or ordinary shares means ordinary shares represented by ADSs. Both terms are used interchangeably.

Dividend Withholding Tax

As a general rule, under current Belgian law, a withholding tax of 30% is levied on the gross amount of dividends paid on or attributed to the ordinary shares represented by the ADSs, subject to such relief as may be available under applicable domestic or tax treaty provisions. Dividends subject to the dividend withholding tax include all benefits attributed to the ordinary shares represented by the ADSs, irrespective of their form. A reimbursement of fiscal capital made in accordance with the Belgian Companies and Associations Code is partly considered to be a distribution of the existing taxed reserves (irrespective whether incorporated into the capital or not) and/or the tax-free reserves incorporated into the capital. The proportion is determined on the basis of the ratio between certain taxed reserves and tax-free reserves incorporated into the capital on the one hand and, on the other hand, the aggregate of such reserves and the fiscal capital. In principle, fiscal capital includes paid-up statutory share capital, and subject to certain conditions, the paid-up issue premiums and the cash amounts subscribed to at the time of the issue of profit sharing certificates.

In case of a redemption by us of own shares represented by ADSs, the redemption distribution (after deduction of the portion of fiscal capital represented by the redeemed shares) will be treated as a dividend which in certain circumstances may be subject to a withholding tax of 30%, subject to such relief as may be available under applicable domestic or tax treaty provisions. In case of a liquidation of our Company, any amounts distributed in excess of the fiscal capital will be subject to a 30% withholding tax, subject to such relief as may be available under applicable domestic or tax treaty provisions.

For non-residents, the dividend withholding tax will be the only tax on dividends in Belgium, unless the non-resident holds ADSs in connection with a business conducted in Belgium, through a fixed base in Belgium or a Belgian permanent establishment.

Relief of Belgian Dividend WithholdingTax

Under the Belgium-United States Tax Treaty (the “Treaty”), there is a reduced Belgian withholding tax rate of 15% on dividends paid by us to a U.S. resident which beneficially owns the dividends and is entitled to claim the benefits of the Treaty under the limitation of benefits article included in the Treaty, (a “Qualifying Holder”). If such Qualifying Holder is a company that owns directly at least 10% of our voting stock, the Belgian withholding tax rate is further reduced to 5%. No withholding tax is however applicable if the Qualifying Holder, is: (i) a company that is a resident of the United States that has owned directly ADSs representing at least 10% of our capital for a 12-month period ending on the date the dividend is declared, or (ii) a pension fund that is a resident of the United States, provided that such dividends are not derived from the carrying on of a business by the pension fund or through an associated enterprise.

Under the normal procedure, we or our paying agent must withhold the full Belgian withholding tax (without taking into account the Treaty rate). Qualifying Holders may make a claim for reimbursement for amounts withheld in excess of the rate defined by the Treaty. The reimbursement form (Form 276 Div-Aut.) may be obtained from the KMO Centrum Specifieke Materies, Team 6, Kruidtuinlaan 50, PO 3429, 1000 Brussels, Belgium or online on the website of the Belgian tax authorities. Qualifying Holders may also, subject to certain conditions, obtain the reduced Treaty rate at source. Qualifying Holders should deliver a duly completed Form 276 Div-Aut. no later than ten days after the date on which the dividend is paid or attributed. U.S. holders should consult their own tax advisors as to whether they qualify for reduction in withholding tax upon payment or attribution of dividends, and as to the procedural requirements for obtaining a reduced withholding tax upon the payment of dividends or for making claims for reimbursement.

Withholding tax is also not applicable, pursuant to Belgian domestic tax law, on dividends paid to certain U.S. pension funds provided that the U.S. pension fund (i) qualifies as a non-resident saver for Belgian withholding tax purposes (i.e., it has a separate legal personality and fiscal residence outside of Belgium and without a permanent establishment or fixed base in Belgium), (ii) has a corporate purpose that consists solely in managing and investing funds collected in order to pay legal or complementary pensions, (iii) has activity that is limited to the investment of funds collected in the exercise of its statutory purpose, without any profit making activity and (iv) is exempt from income taxes in the United States. Furthermore, such pension fund may not contractually be obligated to redistribute the dividends to any beneficial owner of such dividends for whom it would manage the ADSs nor obligated to pay a manufactured dividend with respect to the ADSs under a securities borrowing transaction (save in certain particular cases as described in Belgian law) and subject to certain procedural formalities. A pension fund not holding the shares — which give rise to dividends — for an uninterrupted period of 60 days in full ownership amounts to a rebuttable presumption that the arrangement or series of arrangements which are connected to the dividend distributions, are not genuine. The withholding tax exemption will in such case be rejected, unless counterproof is provided by the OFP that the arrangement or series of arrangements are genuine.

Under Belgian domestic tax law, a withholding tax exemption is available to dividends paid to a non-resident corporate shareholder (located in a Member State of the European Union or in a country with which Belgium has entered in a double tax treaty including sufficient information exchange provisions) provided that (i) at the date of payment or attribution of the dividend it holds a participation in our company representing at least 10% of our share capital, (ii) this holding is held or will be held in full ownership for an uninterrupted period of at least one year, (iii) this non-resident corporate shareholder is tax resident of the country where it is established according to the tax laws of and the bilateral tax treaties established by such country, (iv) this non-resident corporate shareholder is subject to a corporate income tax regime similar to Belgian corporate income tax regime without benefitting from a tax regime that derogates from the ordinary tax regime and (v) its legal form is (similar to one of the legal forms) listed in the annex of the E.U. directive dated July 23, 1990 (90/435/EC) as amended by the directive of December 22, 2003 (2003/123/EC). This reduced withholding tax will apply provided that certain procedural formalities are complied with.

Finally, a withholding tax exemption is available, pursuant to Belgian domestic tax law, to dividends paid to a non-resident corporate shareholder (located in the European Economic Area or in a country with which Belgium has entered in a double tax treaty including sufficient information exchange provisions) to the extent that at the date of payment or attribution of the dividend it holds a participation in our company representing less than 10% of our share capital but the acquisition value of which is at least €2.5 million and provided that certain other conditions are met, i.e., that (i) this holding is held or will be held in full ownership for an uninterrupted period of at least one year (ii) this non-resident corporate shareholder is subject to a corporate income tax regime similar to Belgian corporate income tax regime without benefitting from a tax regime that derogates from the ordinary tax regime, and (iii) its legal form is (similar to one of the legal forms) listed in the annex I, part A, of the E.U. directive dated November 30, 2011 (2011/96/EU) as amended by the directive of July 8, 2014 (2014/86/EU). This reduced withholding tax will apply only if and to the extent that the ordinary Belgian withholding tax cannot be credited or reimbursed to the non-resident corporate shareholder referred to above and subject to certain procedural formalities.

Capital Gains and Losses

Pursuant to the Treaty, capital gains and/or losses realized by a Qualifying Holder from the sale, exchange or other disposition of ADSs do not fall within the scope of application of Belgian domestic tax law.

Capital gains realized on ADSs by a corporate Holder which is not entitled to claim the benefits of the Treaty under the limitation of benefits article included in the Treaty are generally not subject to taxation in Belgium unless the corporate Holder is acting through a Belgian permanent establishment or a fixed place in Belgium to which the ADSs are effectively connected. Capital losses are not deductible.

Private individual Holders who are not entitled to claim the benefits of the Treaty under the limitation of benefits article included in the Treaty and which are holding ADSs as a private investment will, as a rule, not be subject to tax on any capital gains arising out of a disposal of ADSs. Losses will, as a rule, not be deductible in Belgium.However, if the gain realized by such individual Holders on ADSs is deemed to be realized outside the scope of the normal management of such individual’s private estate and the capital gain is obtained or received in Belgium, the gain will in principle be taxable at 33%. The Official Commentary to the ITC 1992 stipulates that occasional transactions on a stock exchange regarding ADSs should not be considered as transactions realized outside the scope of normal management of one’s own private estate.

Capital gains realized by such individual Holders on the disposal of ADSs for consideration, outside the exercise of a professional activity, to a non-resident company (or a body constituted in a similar legal form), to a foreign state (or one of its political subdivisions or local authorities) or to a non-resident legal entity who is established outside the European Economic Area, are in principle taxable at a rate of 16.5% if, at any time during the five years preceding the sale, such individual Holders has owned directly or indirectly, alone or with his/her spouse or with certain relatives, a substantial shareholding in us (that is, a shareholding of more than 25% of our shares).

Capital gains realized by a Holder upon the redemption of ADSs or upon our liquidation will generally be taxable as a dividend. See section “Dividend Withholding Tax.”

Estate and Gift Tax

There is no Belgian estate tax on the transfer of ADSs upon the death of a Belgian non-resident.

Donations of ADSs made in Belgium may or may not be subject to gift tax in Belgium depending on the modalities under which the donation is carried out.

Belgian Tax on Stock Exchange Transactions

A tax on stock exchange transactions (taxesur les opérations de bourse/taks op de beursverrichtingen) is generally levied on the purchase and the sale and on any other acquisition and transfer for consideration of existing ADSs on the secondary market carried out by a Belgian resident investor through a professional intermediary if (i) executed in Belgium through a professional intermediary, or (ii) deemed to be executed in Belgium, which is the case if the order is directly or indirectly made to a professional intermediary established outside of Belgium, either by private individuals having their usual residence in Belgium, or legal entities for the account of their seat or establishment in Belgium.

The applicable rate amounts to 0.35% of the consideration paid but with a cap of €1,600 per transaction and per party. The tax is due separately from each party to any such transaction, i.e., the seller (transferor) and the purchaser (transferee), both collected by the professional intermediary.

However, if the intermediary is established outside of Belgium, the tax will in principle be due by the ordering private individual or legal entity, unless that individual or entity can demonstrate that the tax has already been paid. Professional intermediaries established outside of Belgium can, subject to certain conditions and formalities, appoint a Belgian representative for tax purposes, which will be liable for the tax on stock exchange transactions in respect of the transactions executed through the professional intermediary.

Belgian non-residents who purchase or otherwise acquire or transfer, for consideration, ADSs in Belgium for their own account through a professional intermediary may be exempt from the tax on stock exchange transactions if they deliver a sworn affidavit to the intermediary in Belgium confirming their non-resident status.

No stock exchange tax is payable by: (i) professional intermediaries described in Article 2, 9° and 10° of the Belgian Act of August 2, 2002 acting for their own account, (ii) insurance companies described in Article 2, §1 of the Belgian Act of 9 July 1975 acting for their own account, (iii) professional retirement institutions referred to in Article 2, 1° of the Belgian Act of October 27, 2006 relating to the control of professional retirement institutions acting for their own account, (iv) collective investment institutions acting for their own account, or (v) regulated real estate companies (for the stock exchange tax only).

No stock exchange tax will thus be due by Holders on the subscription, purchase or sale of ADSs, if the Holders are acting for their own account. In order to benefit from this exemption, the Holders must file with the professional intermediary in Belgium a sworn affidavit evidencing that they are non-residents for Belgian tax purposes.

Belgian Annual Tax on Securities Accounts

Pursuant to the Belgian Act of February 17, 2021 introducing a new annual tax on securities accounts due on securities accounts held through an intermediary if the average value of the taxable financial instruments held on this securities account exceeds €1 million during a reference period of 12 consecutive months. This new annual tax on securities accounts is introduced because the previous tax on securities accounts was annulled by the Belgian Constitutional Court.

The annual tax on securities accounts is due irrespective of whether the holder of a securities account is a physical person or a legal entity. If the holder of a securities account is a Belgian resident, the annual tax on securities accounts will be applicable both to securities accounts held in Belgium as well as securities accounts held abroad. For non-residents, only securities accounts held in Belgium fall in scope of the annual tax on securities accounts. A double tax treaty could prevent Belgium to levy the annual tax on securities accounts.

Certain exemptions exist to mitigate the impact of the annual tax on securities accounts on the financial sector. As such, securities accounts held by certain financial undertakings are exempt.

All securities held on a securities account are targeted, such as shares, bonds, participations in investment funds and investment companies, but also derived products, such as index trackers, turbos, real estate certificates and cash. The rate of the annual tax on securities accounts amounts to 0.15% on securities accounts of which the average value exceeds €1 million during a reference period of 12 consecutive months. In order to avoid that the payment of the tax would result in a decrease of the average value below the €1 million threshold, the rate is limited to 10% of the difference between the taxable base and €1 million in those cases. The reference period is a subsequent period of 12 months starting on October 1 and ending September 30 of the subsequent year or (i) any earlier date when the account is closed; or (ii) the moment when the account holder becomes a resident of a state with which Belgium has concluded a tax treaty and the tax treaty allocates the taxing rights to the other state. The average value is calculated by taking the average of the securities accounts values on December 31, March 31, June 30 and September 30.

The tax must be declared and paid by the Belgian resident intermediary with whom the securities account is held. If a securities account is held with a non-resident intermediary, the holder of the securities account itself is responsible for the declaration and the payment of the annual tax on securities accounts. Alternatively, the foreign intermediary could also voluntarily appoint a recognized responsible representative in Belgium to declare and pay the tax.

In case of non-declaration, late, inaccurate or incomplete declaration, as well as non-payment or late payment, a penalty varying from 10% to 200% of the tax due can be imposed. Every holder of the securities account is jointly and severally liable to pay these penalties. The Act furthermore includes a general anti-abuse provision pursuant to which the following is not allowed: (i) distributing taxable financial instruments over different securities accounts to avoid the threshold of €1 million for an individual account, (ii) converting taxable financial instruments into nominative securities (the latter are out of scope of the tax); (iii) transferring a securities account to a foreign legal entity which then transfers the securities to a foreign securities account, etc. In the aforementioned circumstances, there is a refutable presumption that abuse exists. However, the Act also includes situations in which there is an irrefutable presumption of abuse (specific anti-abuse provisions). As such, the following transactions taking place as of October 30, 2020 onwards will be considered to constitute abuse: (i) splitting of a securities account into multiple securities accounts held by the same intermediary; and (ii) the conversion of taxable financial instruments held in a securities account to nominal financial instruments. However, in its judgment of October 27, 2022, the Belgian Constitutional Court annulled the specific anti-abuse provisions as well as the retroactive effect up to October 30, 2020 of the general anti-abuse provision. As a result, only the general anti-abuse provision can still be validly applied and, moreover, only as of February 26, 2021.

Prospective Holders should consult their own tax advisors as to whether they are subject to the new annual tax on securities accounts.

Proposed Financial Transactions Tax

On February 14, 2013, the European Commission published a proposal for a Directive for a common financial transactions tax (“FTT”) in Belgium, Germany, Greece, Spain, France, Italy, Austria, Portugal, Slovenia, Estonia and Slovakia (collectively, the “Participating Member States”). On December 8, 2015, Estonia declared that it will no longer support the FTT.

The proposed FTT has a very broad scope and could, if introduced in its current form, apply to certain dealings in ADSs in certain circumstances. The FTT could apply in certain circumstances to persons both within and outside of the Participating Member States. Generally, it would apply to certain dealings in ADSs where at least one party is a financial institution, and at least one party is established in a Participating Member State.

A financial institution may be, or be deemed to be, “established” in a Participating Member State in a broad range of circumstances, including by transacting with a person established in a Participating Member State.

Currently, the proposed FTT remains subject to further negotiations between the Participating Member States (excluding Estonia). It may therefore be adjusted prior to any implementation, of which the timing and fate remains unclear. Moreover, additional E.U. Member States could decide to participate or drop out of the negotiations. Prospective Holders of ADSs are advised to seek their own professional advice in relation to the FTT.

F. Dividends and Paying Agents

Not applicable.

G. Statement by Experts

Not applicable.

H. Documents on Display

We are subject to the information reporting requirements of the Exchange Act applicable to foreign private issuers and under those requirements file reports with the SEC. Those reports may be inspected without charge at the locations described below. As a foreign private issuer, we are exempt from the rules under the Exchange Act related to the furnishing and content of proxy statements, and our supervisory and executive board members and principal shareholders are exempt from the reporting and short-swing profit recovery provisions contained in Section 16 of the Exchange Act. In addition, we are not required under the Exchange Act to file periodic reports and financial statements with the SEC as frequently or as promptly as United States companies whose securities are registered under the Exchange Act. Nevertheless, we file with the SEC an annual report containing financial statements that have been examined and reported on, with and opinion expressed by an independent registered public accounting firm, and we submit quarterly interim consolidated financial data to the SEC under cover of the SEC’s Form 6-K.

We maintain a corporate website at www.mdxhealth.com. We intend to post our annual report on our website promptly following it being filed with the SEC. Information contained on, or that can be accessed through, our website does not constitute a part of this annual report. We have included our website address in this annual report solely as an inactive textual reference.

The SEC maintains a website (http://www.sec.gov) that contains reports, proxy and information statements and other information regarding registrants, such as MDxHealth, that file electronically with the SEC.

With respect to references made in this annual report to any contract or other document of MDxHealth, such references are not necessarily complete and you should refer to the exhibits attached or incorporated by reference to this annual report for copies of the actual contract or document.

I. Subsidiary Information

Not applicable.

J. Annual Report to Security Holders

If we are required to provide an annual report to security holders in response to the requirements of Form 6-K, we will submit the annual report to security holders in electronic format in accordance with the EDGAR Filer Manual.

ITEM 11. QUANTITATIVE AND QUALITATIVE DISCLOSURESABOUT MARKET RISK

Credit Risk

Credit risk arises from cash and cash equivalents, short-term bank deposits, as well as credit exposure to collaboration partners. Credit risk refers to the risks that counterparty will default on its contractual obligations resulting in financial loss to the Group.

At the end of 2022, the Company operated with more than 1,000 different customers, systematically reducing credit risk compared to prior periods.

In the U.S. healthcare system, and particularly within the molecular diagnostic CLIA-laboratory industry, where there are rapid technological advances in diagnostic services, companies provide services to healthcare professionals and their patients, while being reimbursed from commercial and governmental insurance systems. Often these services are provided out-of-network and without supplier contracts. As a result, there is reimbursement risk, separate from credit risk that is characterized by uncertainty in reimbursement value, delays in payment, and ultimately non-payment. This impacts the Company’s revenue recognition and cash collections.

In addition to reimbursement risk associated with commercial third-party payors, credit risk may also arise from amounts due directly from patients. In many cases, payors will cover the entire cost of testing. For example, for tests that fall under the Clinical Laboratory Fee Schedule, there is no co-payment, co-insurance or deductible for patients covered under traditional Medicare. However, patients covered by commercial insurance companies may be responsible for a co-payment, co-insurance, and/or deductible depending on the health insurance plan and individual patient benefit. Credit risk exists for those patients who cannot meet their co-payment or deductible portions.

Customers’ compliance with agreed credit terms is regularly and closely monitored. Trade accounts receivable amounted to $9.4 million as of December 31, 2022, and no allowance for expected credit loss was recorded. The Company applies the simplified approach to providing for expected credit losses (“ECL”) prescribed by IFRS 9, which requires the use of the lifetime expected loss provision for all trade receivables. No ECL has been recorded for other financial assets carried at amortized cost as there is no related credit risk.

The credit risk on cash and cash equivalents of $15.5 million is limited given that the counterparties are banks with high credit scores attributed by international rating agencies.

Interest Rate Risk

Our cash consists of cash in readily available checking accounts and money market accounts. As a result, the fair value of our portfolio is relatively insensitive to interest rate changes. Our long-term debt bears interest at a fixed rate and therefore has no exposure to changes in interest rates.

Foreign Currency

Our European operations, including all sales and expenses, are denominated in Euros. At the end of each reporting period, these assets and liabilities are converted to U.S. dollars at the then-applicable foreign exchange rate. As a result, our business is affected by fluctuations in exchange rates between the U.S. dollar and foreign currencies. We enter into limited foreign currency hedging transactions to mitigate our exposure to foreign currency exchange risks. Exchange rate fluctuations may adversely affect our expenses, results of operations, financial position and cash flows. However, to date, these fluctuations have not been significant and a movement of 10% in U.S. dollar to the Euro exchange rate would not have a material effect on our results of operations.

ITEM 12. DESCRIPTION OF SECURITIES OTHER THANEQUITY SECURITIES

A. Debt Securities

Not applicable.

B. Warrants and Rights

Not applicable.

C. Other Securities

Not applicable.

D. American Depositary Shares

The Bank of New York Mellon, as depositary, registers and delivers American Depositary Shares, or ADSs. Each ADS represent ten ordinary shares (or a right to receive ten ordinary shares) deposited with ING Belgium SA/NV, as custodian for the depositary in Belgium. Each ADS also represents any other securities, cash or other property that may be held by the depositary. The deposited ordinary shares together with any other securities, cash or other property held by the depositary are referred to as the deposited securities. The depositary’s office at which the ADSs will be administered and its principal executive office are located at 240 Greenwich Street, New York, New York 10286.

A deposit agreement among us, the depositary and the ADS holders sets out the ADS holder rights as well as the rights and obligations of the depositary. New York law governs the deposit agreement and the ADSs. A copy of the Agreement is incorporated by reference as an exhibit to this annual report.

For additional information on our ADSs, please refer to Exhibit 2.3 “Description of Securities registered under Section 12 of the Exchange Act” of this annual report.

Fees and Expenses

Persons depositing or withdrawing ordinary shares or ADS holders must pay:		For:
$5.00 (or less) per 100 ADSs (or portion of 100 ADSs)	●	Issuance of ADSs, including issuances resulting from<br> a distribution of ordinary shares or rights or other property
	●	Cancellation of ADSs for the purpose of withdrawal,<br> including if the deposit agreement terminates
$.05 (or less) per ADS	●	Any cash distribution to ADS holders
A fee equivalent to the fee that would be payable if<br> securities distributed to you had been ordinary shares and the ordinary shares had been deposited for issuance of ADSs	●	Distribution of securities distributed to holders of<br> deposited securities (including rights) that are distributed by the depositary to ADS holders
$.05 (or less) per ADS per calendar year	●	Depositary services
Registration or transfer fees	●	Transfer and registration of ordinary shares on our<br> share register to or from the name of the depositary or its agent when you deposit or withdraw ordinary shares
Expenses of the depositary	●	Cable (including SWIFT) and facsimile transmissions<br> (when expressly provided in the deposit agreement)
	●	Converting foreign currency to U.S. dollars
Taxes and other governmental charges the depositary<br> or the custodian has to pay on any ADSs or ordinary shares underlying ADSs, such as stock transfer taxes, stamp duty or withholding<br> taxes	●	As necessary
Any charges incurred by the depositary or its agents<br> for servicing the deposited securities	●	As necessary

The depositary collects its fees for delivery and surrender of ADSs directly from investors depositing ordinary shares or surrendering ADSs for the purpose of withdrawal or from intermediaries acting for them. The depositary collects fees for making distributions to investors by deducting those fees from the amounts distributed or by selling a portion of distributable property to pay the fees. The depositary may collect its annual fee for depositary services by deduction from cash distributions or by directly billing investors or by charging the book-entry system accounts of participants acting for them. The depositary may collect any of its fees by deduction from any cash distribution payable (or by selling a portion of securities or other property distributable) to ADS holders that are obligated to pay those fees. The depositary may generally refuse to provide fee attracting services until its fees for those services are paid.

From time to time, the depositary may make payments to us to reimburse us for costs and expenses generally arising out of establishment and maintenance of the ADS program, waive fees and expenses for services provided to us by the depositary or share revenue from the fees collected from ADS holders. In performing its duties under the deposit agreement, the depositary may use brokers, dealers, foreign currency dealers or other service providers that are owned by or affiliated with the depositary and that may earn or share fees, spreads or commissions.

The depositary may convert currency itself or through any of its affiliates, or the custodian or we may convert currency and pay U.S. dollars to the depositary. Where the depositary converts currency itself or through any of its affiliates, the depositary acts as principal for its own account and not as agent, advisor, broker or fiduciary on behalf of any other person and earns revenue, including, without limitation, transaction spreads, that it will retain for its own account. The revenue is based on, among other things, the difference between the exchange rate assigned to the currency conversion made under the deposit agreement and the rate that the depositary or its affiliate receives when buying or selling foreign currency for its own account. The depositary makes no representation that the exchange rate used or obtained by it or its affiliate in any currency conversion under the deposit agreement will be the most favorable rate that could be obtained at the time or that the method by which that rate will be determined will be the most favorable to ADS holders, subject to the depositary’s obligation to act without negligence or bad faith. The methodology used to determine exchange rates used in currency conversions made by the depositary is available upon request. Where the custodian converts currency, the custodian has no obligation to obtain the most favorable rate that could be obtained at the time or to ensure that the method by which that rate will be determined will be the most favorable to ADS holders, and the depositary makes no representation that the rate is the most favorable rate and will not be liable for any direct or indirect losses associated with the rate. In certain instances, the depositary may receive dividends or other distributions from us in U.S. dollars that represent the proceeds of a conversion of foreign currency or translation from foreign currency at a rate that was obtained or determined by us and, in such cases, the depositary will not engage in, or be responsible for, any foreign currency transactions and neither it nor we make any representation that the rate obtained or determined by us is the most favorable rate and neither it nor we will be liable for any direct or indirect losses associated with the rate.

PART II

ITEM 13. DEFAULTS, DIVIDENDS ARREARAGES ANDDELINQUENCIES

Not applicable.

ITEM 14. MATERIAL MODIFICATIONS TO THE RIGHTSOF SECURITY HOLDERS AND USE OF PROCEEDS

Not applicable.

ITEM 15. CONTROLS AND PROCEDURES

Disclosure Controls and Procedures

We are responsible for maintaining disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act. Disclosure controls and procedures are controls and other procedures designed to ensure that the information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms. Our management, with the participation of our Chief Executive Officer (principal executive officer) and our Chief Financial Officer (principal financial officer), has evaluated the effectiveness of our disclosure controls and procedures, as of the end of the period covered by this annual report on Form 20-F. Based on the foregoing, our Chief Executive Officer (principal executive officer) and Chief Financial Officer (principal financial officer) concluded that, as of December 31, 2022, our disclosure controls and procedures were effective.

Management’s Annual Report on InternalControl over Financial Reporting

Our management is responsible for establishing and maintaining adequate internal control over our financial reporting (as such term is defined in Rule 13a-15(f) and 15d-15(f) under the Exchange Act). Our management, with the participation of the Chief Executive Officer and the Chief Financial Officer, conducted an assessment of the effectiveness of our internal control over financial reporting as of December 31, 2022 based on the criteria set forth in “Internal Control — Integrated Framework (2013)” issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on this assessment, our management concluded that, as of December 31, 2022, our internal control over financial reporting was effective.

Attestation Report of the Registered PublicAccounting Firm

This annual report does not include an attestation report of the company’s registered public accounting firm due to a transition period established by rules of the SEC for newly public companies, and because MDxHealth is an emerging growth company under the JOBS Act.

Changes in Control over Financial Reporting

There has been no change in our internal control over financial reporting during the year ended December 31, 2022 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

In January 2023, in connection with the preparation of our financial statements for the nine months ended September 30, 2022, (the “Interim Financial Statements”), we identified a material weakness in our internal control over financial reporting at September 30, 2022 related to ineffective design and operation of our interim financial close and reporting controls. More specifically, internal control over financial reporting procedures used in connection with the preparation of the financial information that we reported in a press release issued on October 27, 2022 failed to identify a number of cut-off errors. These cut-off errors have been corrected in the Interim Financial Statements and do not relate to our year-end close and reporting controls. A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of a company’s annual or interim financial statements will not be prevented or detected on a timely basis. Although we were able to remediate these issues, including engaging an outside IFRS consulting firm to assist with our interim closing process, these efforts may not be sufficient to avoid similar material weaknesses in the future.

ITEM 16. [RESERVED]

Not applicable.

ITEM 16A. AUDIT COMMITTEE FINANCIAL EXPERT

Currently, our Audit Committee consists of three directors: Regine Slagmulder, Lieve Verplancke and Hilde Windels. The members of the Audit Committee must have a collective expertise relating to the activities of the Company, and at least one member of the Audit Committee must have the necessary competence in accounting and auditing, including qualifying as an “audit committee financial expert” as defined under the Exchange Act. Our Board of Directors has determined that Regine Slagmulder and Hilde Windels each qualify as an “audit committee financial expert,” as defined by SEC rules and regulations. Regine Slagmulder, Lieve Verplancke, and Hilde Windels are independent under Belgian law and the Nasdaq Stock Market listing requirements.

ITEM 16B. CODE OF ETHICS

We have adopted a Code of Business Conduct and Ethics that is applicable to all of our, and our subsidiaries’, directors, officers and employees. The Code of Business Conduct and Ethics is available on our website at www.mdxhealth.com. Our Board is responsible for overseeing the Code of Business Conduct and Ethics. Any waiver of the Code of Business Conduct and Ethics for our directors or executive officers (including our principal financial officers) may be made only by the Board and will be disclosed to the public as required by law or under applicable listing rules. Waivers of the Code of Business Conduct and Ethics for other employees may be made only by our Chief Executive Officer or Compliance Officer and will be reported to our Audit Committee. All amendments to Code of Business Conduct and Ethics Code must be approved by the Board or a committee thereof and, if applicable, shall be promptly disclosed to the public as required by law or under applicable listing rules.

ITEM 16C. PRINCIPAL ACCOUNTANT FEES AND SERVICES

BDO Réviseurs d’Entreprises SRL, has served as our independent registered public accounting firm for 2022 and 2021. Our accountants billed the following fees to us for professional services in each of those fiscal years:

	Year ended December 31,
	2021		2022
Audit fees for statutory and consolidated financials	$	182,125	$	238,500
Other audit fees	$	183,652	$	191,455
Audit-related and other fees	$	16,569	$	41,811
Tax Fees	$	—	$	—
Total	$	382,346	$	471,766

“Audit Fees” are the aggregate fees billed for the audit of our annual financial statements.

“Other Audit Fees” are mainly the aggregate fees billed in the relation with the Company’s initial public offering (in 2021) and follow on public offering and capital raise process (in 2022).

“Audit-Related Fees” are the aggregate fees billed for assurance and related services that are reasonably related to the performance of the audit and are not reported under Audit Fees. This category also includes services that generally the independent accountant provides, such as consents and assistance with and review of documents filed with the SEC, as well as the aggregate fees billed for statutory audit services as requested by the Belgian Company Code.

“Tax Fees” are the aggregate fees billed for professional services rendered by the principal accountant for tax compliance, tax advice and tax planning related services.

Audit and Non-Audit Services Pre-Approval Policy

The Audit Committee’s policy is to pre-approve all audit and permissible non-audit services to be performed by the independent registered public accounting firm. These services may include audit services, audit-related services, tax services and other services. All such services provided in fiscal 2022 were pre-approved by the Audit Committee. The Audit Committee has delegated pre-approval authority to its chairman when necessary due to timing considerations. Any services pre-approved by such chairman must be reported to the full Audit Committee at its next scheduled meeting.

ITEM 16D. EXEMPTIONS FROM THE LISTING STANDARDSFOR AUDIT COMMITTEES

Not applicable.

ITEM 16E. PURCHASES OF EQUITY SECURITIES BYTHE ISSUER AND AFFILIATED PURCHASERS

Not applicable.

ITEM 16F. CHANGE IN REGISTRANT’S CERTIFYINGACCOUNTANT

Not applicable.

ITEM 16G. CORPORATE GOVERNANCE

Differences between Our Corporate GovernancePractices and the Listing Rules of the Nasdaq Stock Market

The listing rules of the Nasdaq Stock Market include certain accommodations in relation to corporate governance requirements that allow foreign private issuers, to follow “home country” corporate governance practices in lieu of the otherwise applicable corporate governance standards of the Nasdaq Stock Market. The application of such exceptions requires that we disclose each instance of non-compliance with the Nasdaq Stock Market listing rules that we do not follow and describe the Belgian corporate governance practices that we do follow in lieu of the relevant Nasdaq Stock Market corporate governance standard.

We intend to continue to follow Belgian corporate governance practices in lieu of the corporate governance requirements of the Nasdaq Stock Market in respect of the following:

●	Quorum at Shareholder Meetings. Nasdaq Stock Market Listing Rule 5620(c) requires that for any meeting of shareholders, the quorum must be no less<br> than 33.33% of the outstanding shares of common voting stock. There is no general quorum requirement under Belgian law for ordinary<br> meetings of shareholders, except in relation to decisions regarding certain matters. See Item 10B. “Memorandum and Articles of Association” and information set forth in the final prospectus dated November 3, 2021 as part of our Registration Statement<br> on Form F-1 (File No. 333-260213), declared effective by the SEC on November 3, 2021, under the headings “Description of Share Capital and Articles of Association — Articles of Association and Other Share Information — Description of the Rights and Benefits Attached to Our Shares — Quorum and majorities.”
●	Nomination and Remuneration Committee. Nasdaq Stock Market Listing Rule 5605(d)(2) requires that compensation of officers must be determined by, or recommended<br> to, the Board of Directors for determination, either by a majority of the independent directors, or a compensation committee comprised<br> solely of independent directors. Nasdaq Stock Market Listing Rule 5605(e) requires that director nominees be selected, or recommended<br> for selection, either by a majority of the independent directors or a nominations committee comprised solely of independent directors.<br> Under Belgian law, we are not subject to any such requirements. In particular, we are not required by Belgian law to set up any compensation<br> or nominations committees within our Board of Directors, and are therefore not subject to any Belgian legal requirements as to the<br> composition of such committees. However, our Articles of Association provide that our Board of Directors may form committees from<br> among its members. Accordingly, our Board of Directors has set up and appointed a Nomination and Remuneration Committee. Pursuant<br> to article 7:100 of the Belgian Companies and Associations Code, only a majority of the members of the remuneration committee should<br> in principle meet the independence criteria referred to in article 7:87 of the Belgian Companies and Associations Code and set out<br> in provision 3.5 of the Belgian Corporate Governance Code. Pursuant to provision 4.19 of the Belgian Corporate Governance Code, only<br> a majority of the members of the remuneration committee must qualify as independent.
---	---
●	Charters. Nasdaq<br> Stock Market Listing Rules 5605(c)(1), (d)(1) and (e)(2) require that each committee of the Board of Directors must have a formal<br> written charter. Pursuant to the Belgian Corporate Governance Code, our Board of Directors has drawn up a corporate governance charter<br> including, amongst others, the internal rules of our committees.
---	---
●	Independent Director Majority. Nasdaq Stock Market Listing Rules 5605(b)(1) and (2) require that a majority of the Board of Directors must be comprised<br> of independent directors and that independent directors must have regularly scheduled meetings at which only independent directors<br> are present. We are not required under Belgian law to have a majority of independent directors on our Board of Directors. However,<br> our Articles of Association provide that our Board of Directors must be comprised of at least three directors, of which, pursuant<br> to our corporate governance charter and provision 3.4 of the Belgian Corporate Governance Code, at least three directors must be<br> independent directors under Belgian law. Furthermore, in line with the provisions of the Belgian Companies and Associations Code<br> and the Belgian Corporate Governance Code, the Nomination and Remuneration Committee should consist of a majority of independent<br> directors, and the Audit Committee should have at least one independent director among its members
---	---

●	Meetings of Independent Directors. Nasdaq Stock Market Listing Rule 5605(b)(2) requires that independent directors must have regularly scheduled meetings at which only independent directors are present. We do not intend to require our independent directors to meet separately from the full Board of Directors on a regular basis or at all, although the Board of Directors is supportive of its independent members voluntarily arranging to meet separately from the other members of our Board of Directors when and if they wish to do so.
●	Stockholder Approval of Certain Share Issuances. Nasdaq Stock Market Listing Rule 5635(a) requires shareholder approval prior to the issuance of securities in connection with the acquisition of the stock or assets of another company if (1)(A) the common stock has or will have upon issuance voting power equal to or in excess of 20% of the voting power outstanding before the issuance of stock or securities convertible into or exercisable for common stock or (B) the number of shares of common stock to be issued is or will be equal to or in excess of 20% of the number of shares of common stock outstanding before the issuance of the stock or securities; or (2) any director, officer or Substantial Shareholder (as defined in the Nasdaq rules) has a 5% or greater interest (or all such parties have a 10% or greater interest in the aggregate) in the Company or assets to be acquired or in the consideration to be paid in the transaction or series of transactions and the transaction or series of transactions results in an increase in the outstanding common shares or voting power of 5% or more. However, as permitted by Belgian law, we do not need prior stockholder approval to issue shares of authorized stock.
●	Stockholder Approval of Equity Compensation Arrangements. Nasdaq Stock Market Listing Rule 5635(c) requires shareholder approval when a plan or<br> other equity compensation arrangement is established or materially amended. Under Belgian law the establishment or amendment of<br> equity compensation arrangements does not require a prior approval by the general shareholders’ meeting. However, pursuant to<br> Belgian law our shareholders must decide any issuance of new equity, as a general matter. As mentioned in the final prospectus dated<br> November 3, 2021 as part of our Registration Statement on Form F-1 (File No. 333-260213), declared effective by the SEC on November<br> 3, 2021, under the headings “Description of Share Capital and Articles of Association — Articles of Association and Other Share Information — Capital increases decided by the board of directors,” the shareholders may also authorize<br> the Board of Directors, within certain limits, to issue new equity (including equity compensation arrangements) in the framework of<br> the so-called authorized capital. By virtue of a resolution of our extraordinary general shareholders’ meeting of<br> May 27, 2021, our Board of Directors was authorized to issue equity (including equity compensation arrangements) in the<br> framework of the authorized capital. Furthermore, the compensation of director mandates is subject to an approval by the general<br> shareholders’ meeting. See also Item 6B. “Management — Compensation of Our Directors and Executive Management.” In the future, we intend to keep following Belgian home country rules and practice.
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ITEM 16H. MINE SAFETY DISCLOSURE

Not applicable.

ITEM 16I. DISCLOSURE REGARDING FOREIGN JURISDICTIONSTHAT PREVENT INSPECTIONS

Not applicable.

PART III

ITEM 17. FINANCIAL STATEMENTS

Not applicable.

ITEM 18. FINANCIAL STATEMENTS

See pages F-1 through F-45 of this annual report.

ITEM 19. EXHIBITS

Exhibit Index

The following exhibits are filed as part of this annual report:

Exhibit No.	Description of Exhibit	Form	File No.	Filing Date	Filed Herewith
1.1	Articles of Association of MDxHealth SA (English Translation)	6-K	005-93034	March 8, 2023
1.2	Corporate Governance Charter of MDxHealth SA (English Translation)	F-1	333-260213	October 13, 2021
2.1	Form of Deposit Agreement	F-1/A	333-260213	October 28, 2021
2.2	Form of American Depositary Receipt	F-1/A	333-260213	October 28, 2021
2.3	Description of Securities registered under Section 12 of the Exchange Act				X
4.1	March 2012 Stock Option Plan (English Translation)*	F-1	333-260213	October 13, 2021
4.2	May 2012 Stock Option Plan (English Translation)*	F-1	333-260213	October 13, 2021
4.3	May 2014 Stock Option Plan (English Translation)*	F-1	333-260213	October 13, 2021
4.4	May 2017 Stock Option Plan (English Translation)*	F-1	333-260213	October 13, 2021
4.5	2019 Stock Option Plan (English Translation)*	F-1	333-260213	October 13, 2021
4.6	2021 Share Option Plan (English Translation)*	F-1	333-260213	October 13, 2021
4.7	2022 Share Option Plan (English Translation)*	6-K	005-93034	April 28, 2022
4.8	Form of Indemnification Agreement between MDxHealth and each of its officers and directors	F-1	333-260213	October 13, 2021
4.9	Employment Agreement between MDxHealth and Joseph Sollee dated April 14, 2008 and amended January 27, 2014*	F-1	333-260213	October 13, 2021
4.10	Executive Employment Agreement between MDxHealth and Michael K. McGarrity dated February 18, 2019*	F-1	333-260213	October 13, 2021
4.11	Executive Employment Agreement between MDxHealth and John Bellano dated May 21, 2019*	F-1	333-260213	October 13, 2021
4.12	Executive Employment Agreement between MDxHealth and Ron Kalfus dated July 18, 2019*	F-1	333-260213	October 13, 2021
4.13	Amended and Restated License Agreement between The Johns Hopkins University and MDxHealth dated September 1, 2004#	F-1	333-260213	October 13, 2021
4.14	Amendment No. 1 to Restated License Agreement between The Johns Hopkins University and MDxHealth dated April 15, 2005#	F-1	333-260213	October 13, 2021
4.15	Loan and Security Agreement between Innovatus Life Sciences Lending Fund I, LP dated August 2, 2022#				X
4.16	Asset Purchase Agreement between Genomic Health, Inc. and MDxHealth dated August 2, 2022#				X
4.17	Amendment to Asset Purchase Agreement between Genomic Health, Inc. and MDxHealth dated January 1, 2023#				X
4.18	U.S. Small Business Administration Paycheck Protection Program Note, issued by the Company to Customers Bank	F-1/A	333-260213	October 28, 2021

4.19	Lease Agreement between Alton Corporate Plaza LLC and MDxHealth dated December 17, 2019	F-1	333-260213	October 13, 2021
4.20	First Amendment to Lease Agreement between Alton Corporate Plaza LLC and MDxHealth dated April 23, 2020	F-1	333-260213	October 13, 2021
4.21	Second Amendment to Lease Agreement between Alton Corporate Plaza LLC and MDxHealth dated March 23, 2021	F-1	333-260213	October 13, 2021
4.22	Subscription Agreement between MDxHealth and MVM V LP and MVM GP (No. 5) LP dated April 24, 2020	F-1	333-260213	October 13, 2021
8.1	List of subsidiaries of the registrant	20-F	005-93034	April 25, 2022
12.1	Certificate of Principal Executive Officer pursuant to Securities Exchange Act Rules 13a-14(a) and 15d-14(a) as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002				X
12.2	Certification by the Principal Financial Officer pursuant to Securities Exchange Act Rules 13a-14(a) and 15d-14(a) as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002				X
13.1	Certification by the Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002				X
13.2	Certification by the Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002				X
15.1	Consent of BDO Réviseurs d’Entreprises SRL, Independent Registered Public Accounting Firm				X
101.INS	Inline XBRL Instance Document
101.SCH	Inline XBRL Taxonomy Extension Schema Document.
101.CAL	Inline XBRL Taxonomy Extension Calculation Linkbase Document.
101.DEF	Inline XBRL Taxonomy Definition Linkbase Document.
101.LAB	Inline XBRL Taxonomy Extension Label Linkbase Document.
101.PRE	Inline XBRL Taxonomy Extension Presentation Linkbase Document
104	Inline XBRL for the cover page of this Annual Report on Form 20-F (embedded within the Inline XBRL document)
*	Indicates<br>management compensatory plan, contract or arrangement.
---	---
#	Certain<br>confidential portions of this Exhibit were omitted by means of marking such portions with brackets (“[***]”) because the<br>identified confidential portions (i) are not material and (ii) would be competitively harmful if publicly disclosed.
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100

SIGNATURES

The registrant hereby certifies that it meets all of the requirements for filing on Form 20-F and that it has duly caused and authorized the undersigned to sign this annual report on its behalf.

MDXHEALTH SA
/s/<br> Michael McGarrity
By:	Michael McGarrity
Title:	Chief Executive Officer

Date: April 25, 2023

101

MDxHealth SA

INDEX TO THE CONSOLIDATED FINANCIAL STATEMENTS

	Page
Audited Consolidated Financial Statements for the Years Ended December 31, 2022 and 2021
Report<br> of Independent Registered Public Accounting Firm PCAOB ID #1432	F-2
Consolidated Statement of Profit or Loss	F-3
Consolidated Statement of Comprehensive Income	F-4
Consolidated Statement of Financial Position	F-5
Consolidated Statement of Changes in Equity	F-6
Consolidated Statement of Cash Flow	F-7
Notes to Consolidated Financial Statements	F-8

F-1

Report of Independent Registered Public Accounting Firm

Shareholders and Board of Directors

MDxHealth SA

Herstal, Belgium

Opinion on the Consolidated Financial Statements

We have audited the accompanying consolidated statements of financial position of MDxHealth SA (the “Company”) as of December 31, 2022 and 2021, the related consolidated statements of profit or loss, comprehensive income, changes in equity, and cash flows for each of the three years in the period ended December 31, 2022, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2022 and 2021, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2022**,**in conformity with the International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB).

Basis for Opinion

These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.

Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.

/s/ BDO Réviseurs d’Entreprises SRL

We have served as the Company’s auditor since 2003.

Zaventem, Belgium

April 25, 2023

PCAOB ID #1432

F-2

Consolidated statement of profit or loss

Thousands of (except per share amounts) For the years ended December 31
Services	4	36,965		21,937		18,064
Licenses	4	25		250		250
Royalties and other revenues	4	64		52		146
Revenues		37,054		22,239		18,460
Cost of goods & services sold	4	(17,835	)	(11,675	)	(10,416	)
Gross profit		19,219		10,564		8,044
Research and development expenses	5	(7,557	)	(6,673	)	(4,543	)
Selling and marketing expenses	5	(26,582	)	(17,744	)	(16,752	)
General and administrative expenses	5	(23,539	)	(14,149	)	(13,990	)
Other operating income, net	7	559		1,161		118
Operating loss		(37,900	)	(26,841	)	(27,123	)
Financial expenses, net	8	(6,144	)	(2,161	)	(1,539	)
Loss before income tax		(44,044	)	(29,002	)	(28,662	)
Income tax	9	0		0		0
Loss for the year		(44,044	)	(29,002	)	(28,662	)
Loss per share attributable to parent
Basic and diluted,	20	(0.28	)	(0.24	)	(0.34	)

All values are in US Dollars.

F-3

Consolidated statement of comprehensive income

Thousands of $ <br><br>For the years ended December 31
Loss for the year	(44,044	)	(29,002	)	(28,662	)
Other comprehensive income (loss)
Items that will be reclassified to profit or loss:
Exchange differences arising from translation of foreign operations	593		264		(383	)
Total other comprehensive income (loss)	593		264		(383	)
Totalcomprehensive loss for the year (net of tax)	(43,451	)	(28,738	)	(29,045	)

F-4

Consolidated statement of financial position

Thousands of $ For the years ended December 31
ASSETS
Non-current assets
Goodwill	3/10	35,926		0
Intangible assets	11	46,166		3,448
Property, plant and equipment	12	3,791		1,671
Right-of-use assets	12	4,103		3,347
Total non-current assets		89,986		8,466
Current assets
Inventories	13	2,327		1,911
Trade receivables	14/19	9,357		4,582
Prepaid expenses and other current assets	14	1,962		1,615
Cash and cash equivalents	15/19	15,503		58,498
Total current assets		29,149		66,606
TOTAL ASSETS		119,135		75,072
EQUITY
Share capital	22	133,454		128,454
Issuance premium	22	153,177		153,177
Accumulated deficit		(288,346	)	(244,302	)
Share-based compensation	24	11,474		10,607
Translation reserve		(444	)	(1,037	)
Total equity		9,315		46,899
LIABILITIES
Non-current liabilities
Loans and borrowings	16/19	34,914		7,651
Lease liabilities	16	3,091		2,624
Other non-current financial liabilities	16/19	53,537		1,466
Total non-current liabilities		91,542		11,741
Current liabilities
Loans and borrowings	16/19	616		4,441
Lease liabilities	16	1,172		840
Trade payables	18/19	10,178		7,455
Other current liabilities	18	3,985		2,735
Other current financial liabilities	16/19	2,327		961
Total current liabilities		18,278		16,432
Total liabilities		109,820		28,173
TOTAL EQUITY AND LIABILITIES		119,135		75,072

F-5

Consolidated statement of changes in equity

	Attributable to owners of mdxhealth sa
Thousands of $(except number of shares)	Number of<br><br> shares		Share capital <br> & issuance premium			Accumulated<br><br>Deficit			Share-based<br><br> compensation		Translation<br><br> reserve			Totalequity
Notes				22						24
Balance at January 1, 2020		70,528,525		199,190			(186,638	)		8,090		(918	)		19,724
Loss for the year							(28,662	)							(28,662	)
Other comprehensive income												(383	)		(383	)
Total comprehensive income for the year							(28,662	)				(383	)		(29,045	)
Transactions with owners in their capacity as owners:
Issuance of shares		20,162,924		14,186											14,186
Deduction of transaction costs				(311	)										(311	)
Share-based compensation costs										1,295					1,295
Balance at December 31, 2020		90,691,449		213,065			(215,300	)		9,385		(1,301	)		5,849
Balance at January 1, 2021		90,691,449		213,065			(215,300	)		9,385		(1,301	)		5,849
Loss for the year							(29,002	)							(29,002	)
Other comprehensive income												264			264
Total comprehensive income for the year							(29,002	)				264			(28,738	)
Transactions with owners in their capacity as owners:
Issuance of shares		65,277,777		75,339											75,339
Deduction of transaction costs				(6,773	)										(6,773	)
Share-based compensation costs										1,222					1,222
Balance at December 31, 2021		155,969,226		281,631			(244,302	)		10,607		(1,037	)		46,899
Balance at January 1, 2022		155,969,226		281,631			(244,302	)		10,607		(1,037	)		46,899
Loss for the year							(44,044	)							(44,044	)
Other comprehensive income												593			593
Total comprehensive income for the year							(44,044	)				593			(43,451	)
Transactions with owners in their capacity as owners:
Issuance of shares as part of GPS acquisition		6,911,710		5,000											5,000
Share-based compensation costs										867					867
Balance at December 31, 2022		162,880,936		286,631			(288,346	)		11,474		(444	)		9,315

F-6

Consolidated statement of cash flow

Thousandsof $For the years ended December 31
CASH FLOWS FROM OPERATING ACTIVITIES
Operating loss		(37,900	)	(26,841	)	(27,123	)
Depreciation and amortization	11/12	4,909		3,036		3,332
Impairment	11	44		0		273
Share-based compensation	24	867		1,222		1,295
Other non-cash transactions		(473	)	(325	)	26
Cash used in operations before working capital changes		(32,553	)	(22,908	)	(22,197	)
Increase (-) / Decrease (+) in inventories	13	(416	)	413		(1,132	)
Increase (-) in receivables	14	(5,122	)	(1,383	)	2,851
Increase (+) in payables	18/19	3,973		1,330		234
Net cash outflow from operating activities		(34,118	)	(22,548	)	(20,244	)
CASH FLOWS FROM INVESTING ACTIVITIES
Purchase of property, plant and equipment	12	(2,789	)	(896	)	(537	)
Acquisition and generation of intangible assets	11	(1,374	)	0		0
Acquisition of Genomic Prostate Score Business	11	(25,000	)	0		0
Net cash outflow from investing activities		(29,163	)	(896	)	(537	)
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from issuance of shares (net of transaction costs)	22	0		68,566		13,875
Proceeds from loan obligation	16	34,291		0		2,316
Repayment of loan obligation and debt extinguishment costs		(10,805	)	0		0
Payment of lease liability	16	(1,358	)	(1,057	)	(831	)
Payment of interest		(1,412	)	(1,011	)	(1,070	)
Interests received	8	125		11		0
Net cash inflow from financing activities		20,841		66,509		14,290
Net Decrease (-) / increase (+) in cash and cash equivalents		(42,440	)	43,065		(6,491	)
Cash and cash equivalents at beginning of the financial year		58,498		15,953		22,050
Effect on exchange rate changes		(555	)	(520	)	394
Cash and cash equivalents at end of the financial year	14/18	15,503		58,498		15,953

F-7

NOTE 1: Status and principal activity

When used in this report, all references to “MDxHealth”, the “company”, “we”, “our” and “us” refer to MDxHealth, SA and its subsidiaries. MDxHealth is a limited liability company domiciled in Belgium, with offices and labs in Belgium, the United States and The Netherlands.

MDxHealth is a commercial-stage precision diagnostics company committed to providing non-invasive, clinically actionable and cost-effective urologic solutions to improve patient care. The Company’s novel prostate cancer genomic testing solutions combine advanced clinical modeling with genomic data to provide each patient with a personalized cancer risk profile, which provides more accurate and actionable information than standard risk factors (e.g., PSA, DRE, age) used by clinicians.

The Company’s Select mdx and Confirm mdx solutions address men at risk for developing prostate cancer, providing physicians with a clear clinical pathway to accurately identify clinically significant prostate cancer while minimizing the use of invasive procedures that are prone to complications. The Company’s Genomic Prostate Score (GPS) solution addresses men newly diagnosed with early-stage prostate cancer, providing physicians with a clear clinical pathway to make the most informed treatment decision for their individual disease, including active surveillance. The Company’s collective decades of experience in precision diagnostics and its portfolio of novel biomarkers for diagnostic, prognostic and predictive molecular assays supports its active pipeline of new testing solutions for prostate and other urologic diseases.

MDxHealth offers its laboratory solutions from its state-of-the-art, 13,448 square feet, College of American Pathologists (CAP)-accredited and Clinical Laboratory Improvement Amendments of 1988 (“CLIA”) certified, molecular laboratory facility located at its U.S. headquarters in Irvine, California as well as a CLIA-certified lab in Plano, Texas. MDxHealth also operates a molecular laboratory facility, MDxHealth B.V., located in Nijmegen, the Netherlands. This site is ISO 13485:2016 certified and operates a management quality system with the following scope: The design and development, manufacture, service laboratory activities and client services of in vitro diagnostic test kits, in vitro diagnostic reagents used for molecular diagnostic detection of oncological diseases.

The Company is headquartered in Belgium. The parent company, MDxHealth SA, has its registered and corporate office in Cap Business Center, Rue d’Abhooz 31, 4040 Herstal, Belgium. MDxHealth, Inc., the Company’s U.S. subsidiary, is located at 15279 Alton Parkway, Suite 100, Irvine, CA 92618, United States. MDxHealth B.V., the Company’s Dutch subsidiary, is located at Transistorweg 5, 6534 Nijmegen, The Netherlands.

NOTE 2: Summary of Significant AccountingPolicies

2.1.Basis of preparation and statement of compliance

MDxHealth’s consolidated financial statements have been prepared in accordance with the International Financial Reporting Standards (IFRS) and interpretations issued by the IFRS Interpretation Committee (IFRS-IC) applicable to companies reported under IFRS. The financial statements comply with IFRS as issued by the International Accounting Standards Board (IASB), collectively “IFRS”. Additionally, the financial statements are also prepared in accordance with IFRS as endorsed by the European Union (“EU-IFRS”).

The principal accounting policies applied in the preparation of the consolidated financial statements are set out below. These policies have been consistently applied to all the years presented, unless otherwise stated. The functional and presentation currency is the U.S. Dollar and all amounts are presented in thousands of U.S. Dollars ($), rounded to the nearest thousand, unless otherwise indicated.

2.2.Basis of consolidation

The consolidated financial statements incorporate the financial statements of MDxHealth SA (Belgium) and its wholly-owned subsidiaries, including MDxHealth Inc. (United States), and MDxHealth BV (The Netherlands) for each fiscal year ending on December 31.

Subsidiaries are all entities over which the Company has control. The Company controls an entity when the Company is exposed to, or has rights to, variable returns from its involvement with the entity and has the ability to affect those returns through its power to direct the activities of the entity. Subsidiaries are fully consolidated from the date on which control is transferred to the Company. The acquisition method of accounting is used to account for business combinations by the Company.

All intercompany balances, profits and transactions are eliminated upon consolidation.

F-8

2.3.Going Concern

The Company has experienced net losses and significant cash used in operating activities since its inception in 2003, and as of December 31, 2022, had an accumulated deficit of $288.3 million, a net loss of $44.0 million, and net cash used in operating activities of $34.1 million. Management expects the Company to continue to incur net losses and have significant cash outflows for at least the next twelve months. While these conditions, among others, could raise doubt about its ability to continue as a going concern, these consolidated financial statements have been prepared assuming that the Company will continue as a going concern. This basis of accounting contemplates the recovery of its assets and the satisfaction of liabilities in the normal course of business. A successful transition to attaining profitable operations is dependent upon achieving a level of positive cash flows adequate to support the Company’s cost structure.

As of December 31, 2022, the Company had cash and cash equivalents of $15.5 million. In February 2023, the Company raised $40 million in gross proceeds by means of a public offering of 10,000,000 American Depository Shares (ADSs) being the equivalent of 100,000,000 new shares (approximately 38% of the Company’s outstanding shares) at an issue price of $4.00 per ADS (or approximately €0.37 per share) through a public offering. In March 2023, the Company received additional gross proceeds of $3.0 million from the underwriters’ exercise of their overallotment option (for further details of this transaction, refer to Note 27 Subsequent Events). Taking into account the above financial situation and on the basis of the most recent business plan, the Company believes that it has sufficient cash to be able to continue its operations for at least the next twelve months from the date of issuance of these financial statements, and accordingly has prepared the consolidated financial statements assuming that it will continue as a going concern. This assessment is based on forecasts and projections within management’s most recent business plan as well as the Company’s expected ability to realize cost reductions should these forecasts and projections not be met.

COVID-19 and MacroeconomicFactors

The Company does not believe that COVID-19 or the Ukraine war has an impact on the Company’s ability to continue as a going concern. The Company does not have business relationships with Russia or Ukraine. There is no direct or indirect impact of the conflict on the day-to-day business of the Company. The Company is not materially impacted by inflation, supply disruption or cyber-attacks due to the current geopolitical conflict.

With regards to climate-related matters, the Company is not impacted in a material way by extreme weather conditions.

2.4.Use of estimates and judgments

Management makes certain critical accounting estimates and management judgments when applying the Company’s accounting policies, which affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenue and expenses during the reporting period. Estimates and judgments are continuously evaluated based on historical experience and other factors, including expectations of future events, which are believed to be reasonable under the circumstances. In the future, actual experience may differ from these estimates and assumptions.

The areas where assumptions and estimation uncertainties in the financial statements have potentially the most significant effect in 2022, are listed below:

Business combination (see Note 3)

On August 2, 2022, the Company announced it has entered into an agreement with Genomic Health, Inc., a subsidiary of Exact Sciences Corporation (“Exact Sciences”), to acquire the Genomic Prostate Score® (GPS) test (formerly Oncotype DX GPS) from Exact Sciences. The company accounted for this acquisition under the acquisition method of accounting and treated it as a business combination in accordance with IFRS. The purchase price was allocated based on the estimated fair value of net assets acquired and liabilities assumed at the date of the acquisition. Following the closing, an additional aggregate earn-out amount of up to $70 million is to be paid by MDxHealth to Exact Sciences upon achievement of certain revenue milestones related to fiscal years 2023 through 2025. The fair value of this contingent consideration at the acquisition date of August 2, 2022, was assessed at $50.5 million, based on a probability-weighted estimate of the net present value expected to become payable, as further detailed in Note 3. Subsequent fair value adjustments to this contingent consideration classified as financial liability are recognized through the statement of profit or loss.

Revenue recognition (see Note 4):

As further described in Note 2.7 (paragraph “Determining the Transaction Price”), the Company analyzes historical collection data on a quarterly basis and makes adjustments to its estimates. In accordance with IFRS 15, revenue is recognized where such a variable consideration is included in the transaction price only to the extent that it is highly probable that the amount of revenue recognized will not be subject to significant future reversals as a result of subsequent re-estimation.

F-9

Deferred income tax (see Note 9)

Management estimates unused tax credits and tax losses to the extent that it is probable that taxable profit will be available against which the tax credits and tax losses can be utilized. On December 31, 2022, the Company had a consolidated net tax loss carried forward amounting to $285.3 million (2021: $258.5 million), implying a potential deferred tax asset of $71.3 million (2021: $64.6 million). No deferred tax assets have been recognized as of December 31, 2022.

Impairment Testing (see Note 3, 10 and 11)

The Company has recorded Goodwill of $35.9 million as part of the GPS business combination (explained above), which is subject to annual impairment testing. The Company has performed an impairment test as of December 31, 2022, at the level of the entire company which is in line with the level at which management monitors its profitability. All the Company’s cash-generating units (CGUs) are expected to benefit from the synergies of the business combination.

The impairment testing is based on a discounted cash flow (DCF) model, with cash flows for the next five years derived from the internal budgets and a residual value that assumes a perpetual growth rate of 2%. The value in use is sensitive to the discount rate used for the DCF model as well as the expected future cash-inflows and the growth rate used for extrapolation purposes.

Key underlying estimates are considered to be estimated cashflows and the weighted-average cost of capital (WACC) and are further described in Note 10.

Share-Based Payments (see Note 24)

Management estimates the fair value of the equity-settled share-based payment transactions by using the Black-Scholes option valuation model:

●	The dividend return is estimated by reference to the historical<br>dividend payment of the Company; currently, this is estimated to be zero as no dividends have been paid since inception
●	The expected volatility was determined using the average<br>volatility of the stock over the last two years at the date of grant
---	---
●	Risk-free interest rate is based on the interest rate<br>applicable for the 10-year Belgian government bond at the grant date
---	---

Going Concern (note 2.3)

Management needs to make significant judgements whether the Company will have sufficient liquidity to continue operations during the next twelve months. Refer to Note 2.3 for management assessment.

Financial liabilities (note 16)

Other financial liabilities are accounted for at fair value through the statement of profit or loss and include the following:

●	The fair value of the contingent consideration payable to Exact Sciences<br>(for the GPS acquisition) and to NovioGendix, which are presented in the yearend statement of financial position under “other non-current<br>financial liabilities” and “other current financial liabilities” are based on an estimated outcome of the conditional<br>purchase price/contingent payments arising from contractual obligations (level 3 input). These are initially recognized as part of the<br>purchase price and then subsequently measured for fair valued. Any changes to fair value are recorded through “other operating income”<br>in the statement of profit or loss.
o	The fair value of the contingent consideration payable with regard to<br>the GPS acquisition is based on a probability-weighted average estimate based on multiple scenarios varying in timing and amount of earn-out<br>payment. This probability-weighted estimate is then discounted to its net present value taking into account the expected time when the<br>earn-out would become payable in 2024, 2025 and 2026. This contingent consideration was initially recorded along with the purchase price<br>allocation of this business combination as detailed in Note 3. Fair value at December 31, 2022, was estimated at $52.9 million resulting<br>in a fair value adjustment expense of $2.4 million. The Company used a discount rate of 14.95%.
---	---
o	For NovioGendix, fair value adjustments gain for the year<br>ended December 31, 2022, totaled $632,000 and the Company used a discount rate of 12.16%.
---	---
●	The<br>fair value of the derivative financial liabilities related to the initial Kreos drawdown fee of €630,000 is based upon the evolution<br>of the share price of MDxHealth as well as the estimated probabilities that either payment at 150%, or conversion into shares, will be<br>requested by Kreos. Whereas share price of MDxHealth can be considered as a level 1 input, the other variable, being the probability<br>assessment of possible scenarios should be considered as level 3 input. The fair value of the liability for the year ended December 31,<br>2022, is estimated at $891,000.
---	---

The fair value of the derivative financial liabilities related to the Innovatus derivative call option (as detailed in Note 16) was performed using a binomial pricing model which takes into account several factors including the expected evolution in price of an ADS and are considered as level 3 input. The fair value of the liability for the year ended December 31, 2022, is estimated at $0.9 million.

F-10

2.5.New Standards, Interpretations and Amendments

2.5.1. New Standards, Interpretations and Amendments adopted bythe Company

The accounting policies have been consistently applied by the Company and are consistent with those used in previous years.

In the current financial year, the following amendments to standards went into effect for the financial year beginning January 1, 2022, and have been endorsed by the European Union.

●	Amendments<br>to IFRS 3 Business Combinations; IAS 16 Property, Plant and Equipment; IAS 37 Provisions, Contingent Liabilities and Contingent Assets<br>as well as Annual Improvements (effective 1 January 2022). The package of amendments includes narrow-scope amendments to three Standards<br>as well as the Board’s Annual Improvements, which are changes that clarify the wording or correct minor consequences, oversights<br>or conflicts between requirements in the Standards.
o	Amendments to IFRS 3 Business Combinations<br> update a reference in IFRS 3 to the Conceptual Framework for Financial Reporting without<br> changing the accounting requirements for business combinations.
---	---
o	Amendments to IAS 16 Property, Plant and Equipment prohibit a company<br>from deducting from the cost of property, plant and equipment amounts received from selling items produced while the company is preparing<br>the asset for its intended use. Instead, a company will recognize such sales proceeds and related cost in profit or loss.
---	---
o	Amendments to IAS 37 Provisions, Contingent<br> Liabilities and Contingent Assets specify which costs a company includes when assessing whether<br> a contract will be loss-making.
---	---
o	Annual Improvements 2018-2020 make minor<br> amendments to IFRS 1 First-time Adoption of International Financial Reporting Standards,<br> IFRS 9 Financial Instruments, IAS 41 Agriculture and the Illustrative Examples accompanying<br> IFRS 16 Leases.
---	---

This adoption has not had any material impact on the disclosures or on the amounts reported in these financial statements.

2.5.2. Standards and Interpretations issuedbut not yet effective in the current period

Certain new accounting standards and amendments to standards have been published, but were not mandatory for December 31, 2022 reporting period.

The following new standard and amendments have been issued and endorsed by the European Union, but are not mandatory for the financial year beginning January 1, 2022:

●	Amendments<br> to IAS 1 Presentation of Financial Statements and IFRS Practice Statement 2: Disclosure of<br> Accounting policies (effective January 1, 2023). The amendments aim to improve accounting<br> policy disclosures and to help users of the financial statements to distinguish between changes<br> in accounting estimates and changes in accounting policies. The IAS 1 amendment requires<br> companies to disclose their material accounting policy information rather than their significant<br> accounting policies. Further, the amendment to IAS 1 clarifies that immaterial accounting<br> policy information need not be disclosed. To support this amendment, the Board also amended<br> IFRS Practice Statement 2, ‘Making Materiality Judgements’, to provide guidance<br> on how to apply the concept of materiality to accounting policy disclosures. The amendments<br> are effective for annual reporting periods beginning on or after January 1, 2023. Earlier<br> application is permitted (subject to any local endorsement process).
●	Amendments<br> to IAS 8 Accounting policies, Changes in Accounting Estimates and Errors: Definition of Accounting<br> Estimates (effective January 1, 2023). The amendment to IAS 8, ‘Accounting Policies,<br> Changes in Accounting Estimates and Errors’, clarifies how companies should distinguish<br> changes in accounting policies from changes in accounting estimates. The amendments are effective<br> for annual reporting periods beginning on or after January 1, 2023. Earlier application is<br> permitted (subject to any local endorsement process).
---	---
●	Amendments<br> to IAS 12 Income Taxes: Deferred Tax related to Assets and Liabilities arising from a Single<br> Transaction (effective January 1, 2023). The amendments clarify how companies account for<br> deferred tax on transactions such as leases and decommissioning obligations. The main change<br> in the amendments is an exemption from the initial recognition exemption of IAS 12.15(b)<br> and IAS 12.24. Accordingly, the initial recognition exemption does not apply to transactions<br> in which equal amounts of deductible and taxable temporary differences arise on initial recognition.<br> The amendments are effective for annual reporting periods beginning on or after January 1,<br> 2023 and early adoption is permitted.
---	---

F-11

No amendments to standards that are issued but not yet effective are considered to materially affect the Company’s accounting policies or any of the disclosures when applied for the first time.

The following amendments have been issued, but are not mandatory for the financial year beginning January 1, 2022, and have not been endorsed by the European Union:

●	Amendments<br>to IAS 1 ‘Presentation of Financial Statements: Classification of Liabilities as current or non-current’ (effective January<br>1, 2024), affect only the presentation of liabilities in the statement of financial position — not the amount or timing of recognition<br>of any asset, liability income or expenses, or the information that entities disclose about those items. The amendments:
o	clarify that the classification of liabilities<br> as current or non-current should be based on rights that are in existence at the end of the<br> reporting period and align the wording in all affected paragraphs to refer to the “right”<br> to defer settlement by at least twelve months and make explicit that only rights in place<br> “at the end of the reporting period” should affect the classification of a liability;
---	---
o	clarify that classification is unaffected<br> by expectations about whether an entity will exercise its right to defer settlement of a<br> liability; and make clear that settlement refers to the transfer to the counterparty of cash,<br> equity instruments, other assets or services; and
---	---
o	clarify how conditions with which an entity<br> must comply within 12 months after the reporting period, such as covenants, affect the corresponding<br> liability’s classification.
---	---
●	Amendments to IFRS 16 Leases: Lease Liability in a Sale and Leaseback<br>(effective January 1, 2024). The amendments explain how an entity accounts for a sale and leaseback after the date of the transaction,<br>specifically where some or all the lease payments are variable lease payments that do not depend on an index or rate. They state that,<br>in subsequently measuring the lease liability, the seller-lessee determines ‘lease payments’ and ‘revised lease payments’<br>in a way that does not result in the seller-lessee recognizing any amount of the gain or loss that relates to the right of use it retains.<br>Any gains and losses relating to the full or partial termination of a lease continue to be recognized when they occur as these relate<br>to the right of use terminated and not the right of use retained.
---	---

The Company will make an impact analysis in view of the application of the amendment of IAS 1 on its consolidated financial statements.

2.6.Foreign currency translation

Functional and presentation currency

Items included in the financial statements of each of the Company’s entities are measured using the currency of the primary economic environment in which the entity operates (the functional currency). The Company’s functional and presentation currency is the U.S. dollar based on the continuing development of the commercial activities in the U.S. market.

Foreign currency transactions are translated into the functional currency using the exchange rates at the date of the transactions. Foreign exchange gains and losses resulting from the settlement of such transactions and from the translation of monetary assets and liabilities denominated in foreign currencies at year-end exchange rates are generally recognized in profit or loss.

The results and financial positions of foreign operations that have a functional currency different from the presentation currency are translated into the presentation currency as follows:

●	Assets<br>and liabilities for each statement of financial position presented are translated at the closing rate at the date of that balance sheet
●	Income<br>and expenses for each statement of profit or loss and statement of comprehensive income are translated at average exchange rates
---	---
●	All<br>resulting exchange differences are recognized in other comprehensive income
---	---

F-12

2.7.Revenue recognition

Performance obligations and timing of revenuerecognition

The majority of the Company’s revenue is derived from laboratory services with revenue recognized at a point in time when control of the services has transferred to the customer. This is generally when the test results are delivered to the customer.

Minor other Company’s revenue is derived from license fees and royalties:

●	License<br>fees are recognized when the Company has fulfilled all conditions and obligations. If the Company has continuing performance obligations<br>towards the fees, the fee will be recognized on a straight-line basis over the contractual performance period.
●	Royalties<br>are recognized as revenue once the amounts due can be reliably estimated based on the sale of the underlying products and services and<br>when the collection of the royalties can be reasonably assured.
---	---

License up-front (signature fees) and non-refundable fees for access to prior research results and databases are recognized when earned, if the Company has no continuing performance obligations and all conditions and obligations are fulfilled. If the Company has continuing performance obligations towards the fees, the fee will be recognized on a straight-line basis over the contractual performance period.

Royalties are generated from the sales by third parties of products or services which incorporate the Company’s proprietary technology. Royalties are recognized as revenue once the amounts due can be reliably estimated based on the sale of the underlying products and services and when the collection of the royalties can be reasonably assured.

Determining the transaction price

A large portion of the Company’s revenues are derived from Medicare, which reimburses the Company for tests performed on its insured patients. Medicare has set a fixed price (via a Local Coverage Determination or “LCD”) for the Company’s Confirm mdx and GPS tests. Therefore, the amount of revenue recognized from Medicare for these tests is determined by reference to the LCD pricing.

For other patients insured by commercial insurance companies where there is no certainty of the amount that will be paid for services rendered, the Company uses historical collection data – on an individual payor basis – to estimate its future collection and corresponding revenues that should be recognized for each type of test.

The Company analyzes historical collection data on a monthly basis and makes monthly adjustments to its estimates. In accordance with IFRS 15, revenue is recognized where such a variable consideration is included in the transaction price only to the extent that it is highly probable that the amount of revenue recognized will not be subject to significant future reversals as a result of subsequent re-estimation.

When historical collection data is insufficient to estimate future collections, the Company defaults to cash basis, meaning that revenues will not be recognized until actual cash payment is received from the payor.

Total revenue in any given year includes amounts related to tests performed in previous years that relate to:

●	revenue<br> from transactions in previous years that did not previously meet the revenue recognition<br> criteria;
●	differences<br> between the revenue recognized in previous years and the actual amount received; and
---	---
●	reversals<br> of revenue relating to balances that are outstanding for more than 9 months.
---	---

2.8.Segment information

Information for the Company’s operating segments has been determined by reference to the information used by the chief operating decision maker (“CODM”) of the Company to review the performance of the Company and in making decisions on allocation of resources, the nature of the activities and the management structure and accountabilities. The Company’s CEO has been identified as the chief operating decision maker in accordance with his designated responsibility for the allocation of resources to operating segments and assessing their performance through periodic reporting. The CODM periodically reviews the Company’s performance based on information at a company level.

The Company monitors the profitability of the group as a whole given revenues are generated from clinical laboratory service testing and does accordingly not distinguish different business segments.

F-13

2.9.intangible assets

Initial measurement:

Externally acquired

Intangible assets are recognized on business combinations if they are separable from the acquired entity or give rise to other contractual/legal rights. The amounts ascribed to such intangibles are determined using appropriate valuation techniques.

Intangible assets are recognized on the business combinations of NovioGendix in 2015 (Select mdx) and GPS in 2022 and include:

●	Externally<br> acquired intellectual property, including patents, technology and related IP; and
●	Customers
---	---

All were valued through application of the relief from royalty method, except for the customers which were valued on the basis of multi-period excess earnings method.

Externally acquired intangible assets also include patents and software licenses which are initially recognized at cost.

Internally generated intangible assets (developmentcosts)

Development costs are capitalized when the following can be demonstrated:

●	It<br> is technically feasible to develop the product for it to be sold;
●	Adequate<br> resources are available to complete the development;
---	---
●	There<br> is an intention to complete and sell the product;
---	---
●	The<br> Company is able to sell the product;
---	---
●	Sale<br> of the product will generate future economic benefits; and
---	---
●	Expenditures<br> on the project can be measured reliably.
---	---

Internally generated intangible assets relate to Confirm mdx, Select mdx, Resolve mdx and GPS.

Subsequent measurement

Intangible assets are carried at their cost less any accumulated amortization and any accumulated impairment losses amortized on a straight-line basis over their estimated useful lives on the following basis:

●	Patents<br> & software: shorter of (a) 5 years; or (b) the software license period / patent life
●	Intellectual property: 10-15 years
---	---
●	Customers: 6.5 years
---	---
●	Capitalized development costs: 5 years
---	---

Amortization over the asset’s useful life shall begin when the asset is available for use.

2.10.Property, plant and equipment

Property, plant and equipment are stated at historical cost less accumulated depreciation and impairment. Repair and maintenance costs are charged to the income statement as incurred. Gains and losses on the disposal of property, plant and equipment are included in other income or expenses. Depreciation is charged to write off the cost or valuation of assets over their useful lives, using the straight-line method, on the following basis:

●	Equipment:<br> 5 years
●	IT<br> hardware and software: 3 years
---	---

F-14

●	Furniture:<br> 5 years
●	Vehicles:<br> 5 years
---	---
●	Leasehold<br> improvements: in line with the non-cancellable lease period of the related lease
---	---

2.11.Right-of-use assets and liabilities

Right-of-use assets:

The Company recognizes right-of-use assets at the commencement date of the lease (i.e., the date the underlying asset is available for use). Right-of-use assets are measured at cost, less any accumulated depreciation and impairment losses, and adjusted for any remeasurement of lease liabilities. The cost of right-of-use assets includes the amount of lease liabilities recognized, initial direct costs incurred, and lease payments made at or before the commencement date less any lease incentives received. Unless the Company is reasonably certain to obtain ownership of the leased asset at the end of the lease term, the recognized right-of-use assets are depreciated on a straight-line basis over the shorter of its estimated useful life and the lease term. Depreciation periods range between 3 and 6 years. Right-of-use assets are subject to impairment.

Lease liabilities:

At the commencement date of the lease, the Company recognizes lease liabilities measured at the present value of lease payments to be made over the lease term. The lease payments include fixed payments (including in substance fixed payments) less any lease incentives receivable, variable lease payments that depend on an index or a rate, and amounts expected to be paid under residual value guarantees. The lease payments also include the exercise price of a purchase option reasonably certain to be exercised by the Company and payments of penalties for terminating a lease, if the lease term reflects the Company exercising the option to terminate. The variable lease payments that do not depend on an index or a rate are recognized as expense in the period on which the event or condition that triggers the payment occurs. In calculating the present value of lease payments, the Company uses the incremental borrowing rate at the lease commencement date which is in the following ranges:

●	Buildings: 10% and 11%
●	Vehicles: 2.5% and 3.75%
---	---
●	Materials: 5% and 6%
---	---

After the commencement date, the amount of lease liabilities is increased to reflect the accretion of interest and reduced for the lease payments made. In addition, the carrying amount of lease liabilities is remeasured if there is a modification, a change in the lease term, a change in the in-substance fixed lease payments or a change in the assessment to purchase the underlying asset.

Short-term leases and leases of low-valueassets:

The Company applies the short-term lease recognition exemption to its short-term leases of machinery and equipment (i.e., those leases that have a lease term of 12 months or less from the commencement date and do not contain a purchase option). It also applies the lease of low-value assets recognition exemption to leases of office equipment that are considered of low value (i.e., below $5,000). Lease payments on short-term leases and low-value assets are recognized in the consolidated statement of profit or loss as incurred.

2.12.Impairment of assets

Goodwill and intangible assets that have an indefinite useful life are not subject to amortization and are tested annually for impairment, or more frequently if events or changes in circumstances indicate that they might be impaired. Other assets are tested for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. An impairment loss is recognized for the amount by which the asset’s carrying amount exceeds its recoverable amount. The recoverable amount is the higher of an asset’s fair value less costs of disposal and value in use. The Company monitors its Goodwill at consolidated Company level which is the level of the Company of cash-generating units (CGUs) benefiting from the synergies. Non-financial assets other than Goodwill that suffered an impairment are reviewed for possible reversal of the impairment at the end of each reporting period.

2.13.Inventories

Inventories are initially recognized at cost, and subsequently at the lower of cost and net realizable value. Cost comprises merely purchase costs, as the inventory consists solely of raw materials. Raw materials are not ordinarily interchangeable, and they are as such accounted for using the specific identification of their individual cost.

The Company does not account for work in progress and finished products.

F-15

2.14.Government Grants

A government grant is only recorded as a receivable when (i) the grant has been approved by the granting party, (ii) the amounts are measurable, and (iii) the Company believes it will meet the conditions necessary to be able to receive/use the grant.

Government grants are recognized as other operating income over the life of the grant as the required or planned activities are performed and the related costs are incurred, and when there is reasonable assurance that the Company will comply with the conditions of the grant.

2.15.Cash and cash equivalents

Cash and cash equivalents are carried on the consolidated statement of financial position at nominal value. For the purposes of the cash flow statements, cash and cash equivalents comprise cash on hand, deposits held on call with banks, other short-term highly liquid investments and bank overdrafts. Bank overdrafts, if any, are included in borrowings included in current liabilities.

2.16.Taxation

Current tax assets and liabilities for the current period are measured at the amount expected to be recovered from or paid to the taxation authorities. The tax rates and tax laws used to compute the amount are those that are enacted or substantively enacted, at the reporting date.

Deferred income tax is provided in full using the “balance sheet liability method”, on temporary differences between the carrying amount of assets and liabilities for financial reporting purposes and the amounts used for taxation purposes.

Deferred tax liabilities are recognized for all taxable differences. Deferred tax assets are recognized for all deductible temporary differences, carry forward of unused tax credits and unused tax losses, to the extent that it is probable that taxable profit will be available against which the deductible temporary differences, and the carry forward of unused tax credits and unused tax losses can be utilized.

The carrying amount of deferred tax assets is reviewed at each reporting date and reduced to the extent that it is no longer probable that sufficient taxable profit will be available to allow all or part of the deferred tax asset to be utilized. Unrecognized deferred tax assets are reassessed at each reporting date and are recognized to the extent that it has become probable that future taxable profits will allow the deferred tax asset to be recovered.

Deferred tax assets and liabilities are measured at the tax rates that are expected to apply in the year when the asset is realized or the liability is settled, based on tax rates (and tax laws) that have been enacted or substantively enacted at the reporting date.

Deferred tax assets and deferred tax liabilities are offset, if a legally enforceable right exists to set off current tax assets against current income tax liabilities and the deferred taxes relate to the same taxable entity and the same taxation authority.

2.17.Share Capital

Ordinary shares are classified as equity. Incremental costs directly attributable to the issue of new shares or options are shown in equity as a deduction, net of tax, from the proceeds.

2.18.Financial Assets

The financial assets consist mainly of trade receivables and other current assets (deposits).

Classification and measurement on initial recognition

The classification of financial assets at initial recognition depends on the financial asset’s contractual cash flow characteristics and the Company’s business model for managing them.

The company initially measures a financial asset at its fair value plus, in the case of a financial asset not at fair value through profit or loss, transaction costs.

For both trade receivables that do not contain a significant financing component, and trade receivables for which the collection is expected in less than one year, the Company has applied the simplified approach to providing for expected credit losses (ECL) prescribed by IFRS 9, which requires the use of the lifetime expected loss provision for all trade receivables.

F-16

Trade receivables do not carry any interest and are recognized initially at fair value and subsequently measured at amortized cost using the effective interest method, less provision for impairment based on expected credit losses, where applicable.

Subsequent measurement

After initial recognition, trade receivables and some other current assets as listed in Note 14 are measured at amortized cost using the effective interest method, less provision for impairment based on expected credit losses.

2.19.Financial Liabilities

The financial liabilities consist mainly of loans and borrowings, lease liabilities, trade and other payables and other financial liabilities that include derivative financial liabilities and contingent consideration related to business combinations.

Measurement on initial recognition

At initial recognition, financial liabilities are measured at fair value less transaction costs unless the financial liability is carried at fair value through the statement of profit or loss, in which case the transaction costs are immediately recognized in the statement of profit or loss. The best estimate of the fair value at initial recognition is usually the transaction price, represented by the fair value of the consideration given or received in exchange for the financial instrument. Any difference between the fair value estimated by the entity and the transaction price (“day one gain or loss”) is recognized:

●	in<br> the statement of profit or loss if the estimate is evidenced by a quoted price in an active<br> market; and
●	deferred<br> as an adjustment to the carrying amount of the financial instrument in all other cases.
---	---

The fair value of the contingent consideration payable at the date of acquisition is computed as the sum of the probability-weighted fair values of the purchase prices, as follows:

●

GPS: the liability recognized reflects a probability-weighted estimate at the current net present value at the date of acquisition, which is expected to become payable.

●

Noviogendix: each of the potential product development paths. The fair value of each path is in turn computed as the sum of the survival probability discounted to present values of the contingent payments in each such path, including the milestone and commercialization payments. Any other financial liability included in the consideration payable for a business combination is recorded at fair value at the date of acquisition.

---

The derivative financial instrument related to the Innovatus debt facility option to convert up to 15% of the outstanding aggregate principal amount into ordinary shares of the Company for a period up to August 2, 2025, is accounted for at fair value with a portion of the transaction costs allocated to the embedded derivative being expensed as incurred. The embedded derivative will be measured as an American call option using a binomial tree option pricing model with changes to fair value being recorded in the statement of profit or loss under Financial expenses, net, as described further in Note 16.

The derivative financial instrument related to the initial drawdown fee of the Kreos debt facility, which is either convertible into shares of the Company or repayable in cash at 150% at the discretion of Kreos through 2029, is computed as the sum of the probability-weighted values of the fair values associated with each of the possible outcomes further described in Note 16.

Subsequent measurement

After initial recognition, loans and borrowings, lease liabilities, trade and other payables, are measured at amortized cost using the effective interest method. Contingent considerations and derivative financial liabilities are measured at fair value are reviewed at each reporting period, with any changes in fair value recorded in the statement of profit and loss.

2.20.Retirement benefit plans and employee savings plans

Payments to defined contribution employee savings plans are charged as an expense as they fall due. The Company does not offer nor operate any material defined benefit plans for its employees. With respect to Belgian pension plans and as explained in Note 23, the Company has considered the potential impact of the employer’s legal obligation to guarantee a minimum return on the Belgian pension plans and that this was assessed not to be significant.

2.21.Share-based compensation plans for personnel, directors and business associates

The Company grants stock options in accordance with several share-based compensation plans in consideration for services performed by personnel, directors and business associates. The cost of the services rendered is measured at the fair value of the granted options and recognized as an expense in the statement of profit or loss. The corresponding credit is recorded directly into equity.

F-17

The estimate of the number of options which will ultimately vest is revised at each reporting date. The change in estimate is recorded as an expense with a corresponding correction in equity.

The received amount, less directly attributable transaction costs, will be recorded as share capital and share premium when the options are exercised.

NOTE 3: Business combination

Acquisition of Genomic Prostate Score^®^(GPS) test (formerly Oncotype DX GPS) from Exact Sciences

On August 2, 2022, the Company announced it has entered into an agreement with Genomic Health, Inc., a subsidiary of Exact Sciences Corporation (“Exact Sciences”), to acquire the GPS test from Exact Sciences. MDxHealth acquired GPS in order to expand its menu of tests targeted into urology and prostate cancer and in order to position the Company as one of the leaders in the urology and prostate cancer space with one of the most comprehensive menus of precision diagnostics.

Under the terms of the agreement, the Company acquired the GPS prostate cancer business of Exact Sciences for an aggregate purchase price of up to $100 million, of which an amount of $25 million was paid in cash and an amount of $5 million was settled through the delivery of 691,171 American Depositary Shares (“ADSs”) of the Company, at a price per ADS of $7.23. Following the closing, which took place on August 2, 2022, an additional aggregate earn-out amount of up to $70 million is to be paid by the Company to Exact Sciences over a three year period, commencing in 2024, in tranches equal to a portion of the annual revenues attributable to the GPS prostate cancer business for the preceding fiscal year; provided, in each instance, that such revenues exceed certain minimum revenue milestones for such fiscal year.

At the option of MDxHealth, the earn-out amounts can be settled in cash or through the issuance of additional ADSs of the Company (valued in function of a volume weighted average trading price of the Company’s shares at the end of the relevant earn-out period) to Exact Sciences, provided that the aggregate number of shares representing the ADSs held by Exact Sciences shall not exceed more than 5% of the outstanding shares of the MDxHealth.

The Acquisition was accounted for under the acquisition method of accounting and is being treated as a business combination in accordance with IFRS given that there are inputs from the intellectual property and customers acquired, a substantive process, consisting of a workforce that was hired from Exact Sciences, which allows the Company to generate outputs as from day 1 of the acquisition. The purchase price was allocated based on the estimated fair value of net assets acquired and liabilities assumed at the date of the acquisition.

The acquisition consideration was comprised of (in thousands USD):

Cash	$	25,000
Stock		5,000
GPS Contingent consideration		50,483
Total acquisition consideration	$	80,483

The purchase price in excess of the fair value of net assets acquired, has been considered as residual Goodwill for an amount of $35.9 million.

The fair value of the identifiable assets at the date of acquisition were:

Thousands of $ As of December 31, 2022
Intangible assets IP / Brand	-	36,550	36,550
Intangible assets Customer relationships	-	8,007	8,007
Total identified assets	-	44,557	44,557
Goodwill	-	35,926	35,926
Acquisition price	-	-	80,483

We have performed a fair value analysis of the business combination, with corresponding adjustments to the intangible assets.

The accounting for the business combination resulted in fair values at date of acquisition of $44.6 million for the IP/brand and customer relationships, based on the relief-from-royalty valuation method, with a royalty rate of 9.56% and a remaining useful life of 15 years for the IP/Brand and a useful life of 6.5 years for the customer relationships. The discount rate (post-tax WACC) used for the valuation was set at 14.95%. The goodwill recognized is primarily attributable to the trained and knowledgeable workforce and to the expected synergies that will be realized at level of operations, existing customer base, and sales & marketing.

F-18

Following the closing, an additional aggregate earn-out amount of up to $70 million is to be paid by MDxHealth to Exact Sciences upon achievement of certain revenue milestones related to fiscal years 2023 through 2025. The contingent consideration has been assessed at $52.9 million for the year ended December 31, 2022. The liability recognized reflects a probability-weighted estimate at the current net present value at the date of acquisition, which is expected to become payable, as further detailed in Note 16. Future fair value adjustments to this contingent consideration will be recognized in the statement of profit or loss.

The net deferred tax asset resulting from this purchase price allocation was not recognized given insufficient future taxable profits. The recognized goodwill is expected to be fully tax deductible upon actual payment of the contingent consideration.

The total acquisition-related costs recognized as an expense in General & administrative expenses were $3.7 million.

The GPS acquisition has contributed $9.3 million to the Company’s consolidated revenues for the period ended December 31, 2022. Per the unaudited special purpose financial statements for the GPS business filed as exhibit 99.1 to Form 6-K on December 19, 2022, the GPS business generated revenues of $18.5 million for the six-month period ended June 30, 2022. Revenue information for the month of July 2022 is not available and the Company does not segregate the net result of the GPS stand-alone business.

The Company financed the acquisition in part through a $35 million loan and security agreement with an affiliate of Innovatus Capital Partners, LLC (“Innovatus”), which replaced the Company’s existing €9 million debt facility with Kreos Capital (“Kreos”). Refer to Note 16 for further details.

NOTE 4: Revenue and Cost of goods &services sold

Revenue

Thousandsof $ For the years ended December 31
Services	36,965	21,937	18,064
Licenses	25	250	250
Royalties and other revenues	64	52	146
Total revenue	37,054	22,239	18,460

Revenues related to services are recognized at a point in time while licenses, royalties and other revenues are generally recognized over time as described in Note 2.7.

The Company did not recognize any contract assets or contracts liabilities.

Total revenue for 2022 was $37.1 million, an increase of 67% as compared to total revenue of $22.2 million for 2021. Excluding revenues from the recently acquired GPS test, total revenue for 2022 was $27.7 million, an increase of 25% versus 2021. Total revenue of $22.2 million for 2021 increased of 20% compared to total revenue of $18.5 million for 2020. Revenues from sales of Confirm mdx accounted for 59%, 91%, and 94% of total revenues in 2022, 2021, and 2020, respectively. 2022 revenues were comprised of $21.8 million from Confirm mdx, $9.3 million from GPS, $4.9 million from Resolve mdx, with the remaining revenues from Select mdx and other.

Medicare

In July 2022, a foundational LCD covering the indication for the Select mdx test became effective under the Molecular Diagnostic Services Program (“MolDX”), administered by Palmetto GBA, which handles technical assessments for U.S. laboratories that perform molecular diagnostic testing. Under the foundational LCD process recently implemented by MolDX, all tests within an LCD-covered indication must submit a technical assessment (“TA”) for review and consideration. A technical assessment requesting coverage for Select mdx has been submitted and the Company is engaged in an interactive review process with MolDX. Based on the Company’s most recent communications with MolDX, a final coverage decision is not expected until mid-year 2023. A final determination with respect to Medicare coverage and reimbursement of the Select mdx test therefore remains pending, and there can be no assurance that such coverage and reimbursement will be granted or, if granted, that it will be maintained.

In 2022, Medicare represented the only payer generating over 10% of the Company’s revenues, for a total of $15.8 million (2021: $8.5 million; 2020: 8.2 million).

At the end of 2022, the Company had concluded agreements with 129 commercial payors for Confirm mdx (2021: 119; 2020: 107) and 62 commercial payors for Select mdx (2021: 54; 2020: 42).

F-19

Segment revenue

The Company does not distinguish different business segments since most revenues are generated from clinical laboratory service testing, or the out-licensing of the Company’s patented DNA methylation platform and biomarkers. However, the Company does distinguish different geographical operating segments based on revenue since the revenues are generated both in United States of America and Europe.

In 2022, the Company earned 99.8% (2021: 98.6%; 2020: 97.9%) of its revenue from external customers from its clinical laboratory testing services and out-licensing of intellectual property. In 2022, the clinical laboratory testing in the U.S. CLIA laboratory represented 99% of the Company’s revenue (2021: 97%; 2020: 95%), while the out-licensing of intellectual property revenue in Europe represented less than 1% (2021: 1.5%; 2020: 3%).

The amount of its revenue from external customers broken down by location is shown in the table below:

Thousands of $<br> For the years ended December 31
United States of America	36,768	21,785	17,760
Europe	277	441	679
Rest of the world	9	13	21
Total segment revenue	37,054	22,239	18,460

At the end of 2022, 93% of the non-current assets were located in the US (2021: 38%; 2020: 40%) and the remaining 7% in Europe (2021: 62%; 2020: 60%). The increase in non-current assets located in the U.S. is mainly due to acquired intangible assets in the GPS business combination as detailed in Note 3.

Costof goods & services sold

Thousands of $<br> For the years ended December 31	**<br><br>2022**		**<br><br>2021**		2020
Cost of goods & services sold		17,835		11,675		10,416
Total cost of goods & services sold		17,835		11,675		10,416

The costs of goods & services sold include the costs associated with providing testing services to third parties and include the cost of materials, labor (including salaries, bonuses, and benefits), transportation, collection kits, and allocated overhead costs associated with processing samples. Allocated overhead costs include depreciation of laboratory equipment, facility occupancy and information technology costs. Costs associated with processing samples are expensed when incurred, regardless of the timing of revenue recognition.

NOTE 5: Nature of expenses

Researchand development expenses

Thousandsof $ For the years ended December 31
Personnel costs	6	2,453	1,949	1,277
Depreciation and amortization	11/12	2,272	1,360	1,203
Impairment	11	44	0	273
Lab consumables		713	793	390
Patent expenses		430	577	396
External collaborator fees		783	1,020	874
Clinical validation		584	842	0
Other expenses		278	132	130
Total research and development expenses		7,557	6,673	4,543

Research and development expenses consist of costs incurred for the development and improvement of our products. These expenses consist primarily of labor costs (including salaries, bonuses, benefits, and stock-based compensation), reagents and supplies, clinical studies, outside services, patent expenses, depreciation of laboratory equipment, facility occupancy and information technology costs. Research and development expenses also include costs associated with assay improvements and automation workflow for our current suite of products. The Company expenses its research and development expenses in the period in which they are incurred, except for those development expenses that qualify for capitalization (refer to Note 11).

F-20

Total research and development expenses increased by 13% over 2021, primarily due to the amortization expenses related to the acquired IP and brand for the GPS business, as well as an increase in lab consumables, partially offset by savings in patent expenses, clinical validation, and external collaborator fees.

A change in presentation for clinical validation expenses has been brought in 2021 to report clinical validation expenses in the amount of $842,000 under Research and Development, previously under Selling and Marketing expenses.

Sellingand Marketing expenses

Thousandsof $ For the years ended December 31
Personnel costs	6	19,070	13,402	12,839
Depreciation and amortization	11/12	1,628	796	603
Professional fees		1,259	523	497
Marketing expenses		2,843	1,761	1,315
Travel expenses		789	340	260
Offices & facilities expenses		356	436	503
Clinical validation		0	0	377
Other expenses		637	486	358
Total selling and marketing expenses		26,582	17,744	16,752

The Company’s sales and marketing expenses are expensed as incurred and include costs associated with its sales organization, including its direct clinical sales force and sales management, medical affairs, client services, marketing and managed care, as well as technical lab support and administration. These expenses consist primarily of labor costs (including salaries, bonuses, benefits, and stock-based compensation), customer education and promotional expenses, market analysis expenses, conference fees, travel expenses and allocated overhead costs.

For the year ended December 31, 2022, selling and marketing expenses increased by $8.8 million, or 50%, compared to 2021, primarily due to an increase in personnel costs and marketing expenses related to the Company’s acquisition of the GPS business as well as an increase in amortization expense related to customer lists as part of the GPS intangible asset.

For the year ended December 31, 2021, selling and marketing expenses increased $1.0 million, or 6%, compared to 2020, primarily due to increased activity in 2021 versus 2020, which was the first year of the COVID-19 pandemic.

Generaland administrative expenses

Thousands of $<br> For the years ended December 31
Personnel costs	6	8,995	9,009	9,209
Depreciation and amortization	11/12	965	880	1,526
Professional fees		7,762	1,678	1,522
Public company expenses		4,025	1,108	584
Offices & facilities expenses		1,142	845	530
Royalties to third parties		47	152	107
Other expenses		603	477	512
Total general and administrative expenses		23,539	14,149	13,990

General and administrative expenses include costs for certain executives, accounting and finance, legal, revenue cycle management, information technology, human resources, and administrative functions. These expenses consist primarily of labor costs (including salaries, bonuses, benefits, and stock-based compensation), professional service fees such as consulting, accounting, legal, general corporate costs, and public-company costs associated with the Company’s listing, as well as allocated overhead costs (rent, utilities, insurance, etc.).

General and administrative expenses increased in 2022 by $9.4 million, of which $3.7 million were one-time expenses related to the GPS acquisition (included in Professional fees), with the remaining $5.7 million increase primarily related to higher insurance, professional fees and public company expenses.

General and administrative expense increased in 2021 by $0.2 million, or 1% compared to 2020, primarily due to an increase in professional fees and insurance expenses associated with our U.S. listing on the Nasdaq Stock Market.

F-21

NOTE 6: Personnel costs

Thousands of $<br> For the years ended December 31
The number of employees at the end of the year was:
Laboratory operations	67	42	39
R&D staff	19	14	17
S&M staff	101	71	64
G&A staff	71	64	57
Total number of employees	258	191	177
Their aggregate remuneration comprised:
Wages and salaries	23,066	18,150	17,552
Social security costs	1,684	1,257	1,275
Pension costs	724	594	567
Health insurance expenses	3,167	2,324	2,093
Share-based compensation	867	1,222	1,295
Other costs	1,010	813	543
Total personnel costs	30,518	24,360	23,325

The personnel numbers in the table reflect year-end numbers, with 42 sales and marketing employees hired in August 2022 as part of the GPS acquisition.

NOTE 7: Other operating income, net

Thousands of $<br> For the years ended December 31
Grant subsidies – The Netherlands^1^	5	382		0
Grant subsidies – USA	0	659		0
Fair value adjustments	515	176		118
Other operating income	39	53		0
Other operating expenses	0	(109	)	0
Total other operating income, net	559	1,161		118

1)	2020 grant income of $88,000 is classified under “Royalties and other revenues”

Other operating income for the year ended December 31, 2022, primarily consisted of a positive fair value adjustment of $632,000 of the contingent consideration related to the acquisition of NovioGendix in 2015, partially offset by a negative fair value adjustment of $117,000 related to the initial Kreos drawdown derivative financial instrument.

Other operating income, net, decreased $602,000 for 2022 compared to 2021, primarily due to reductions in grant income, partially offset by the above-mentioned fair-value adjustments.

The increase of $1.0 million for 2021 as compared to 2020 is primarily related to $659,000 grant income from the U.S. Department of Health and Humas Services as well as a $382,000 grant from the Dutch government NOW grants, both considered support for COVID-19 inefficiencies. Management considers there are no pending conditions left.

NOTE 8: Finance expenses, net

Thousands of $<br> For the years ended December 31
Interest income	125		11		4
Interest on Kreos loan	(660	)	(1,566	)	(1,205	)
Interest on Innovatus loan	(1,615	)	0		0
Interest on other loans and leases	(361	)	(309	)	(145	)
Fair value adjustments	(2,479	)	(290	)	(118	)
Kreos loan extinguishment	(1,047	)	0		0
Other financial expenses	(107	)	(7	)	(75	)
Financial expenses, net	(6,144	)	(2,161	)	(1,539	)

F-22

For the year ended December 31, 2022, financial expenses, net, were primarily comprised of fair value adjustments for the GPS contingent consideration of $2.4 million resulting from changes in net present value, interest charges and extinguishment expenses of $1.6 million for the loan facility with Kreos Capital (as further detailed in Note 16), and interest charges of $1.6 million related to the Innovatus debt facility.

Other financial expenses relate to bank costs incurred during the year.

NOTE 9: Income Tax

No income taxes were payable in view of the losses incurred by the Company. On December 31, 2022, the Company had a consolidated net tax loss carried forward amounting to $285.3 million (2021: $258.5 million; 2020: $276.1 million), implying a potential deferred tax asset of $71.3 million (2021: $64.6 million; 2020: $69.0 million) at a tax rate of 25%.

The tax losses related to MDxHealth SA in Belgium are available for carry forward. Until 2021, tax losses related to MDxHealth BV in the Netherlands are available for carry forward to a period of 6 years. As of 2022, tax losses related to MDxHealth BV in the Netherlands are available for carry forward indefinitely. The tax losses of MDxHealth Inc., related to the years beginning on or after January 1, 2018, are available for carry forward indefinitely. Tax losses related to the years before January 1, 2018, can be carried forward to a period of 20 years.

The Company has no notional interest deduction to offset future taxable profits in 2022, 2021, and 2020.

Tax credits (investment deductions) amounted to $402,000 in 2022, $372,000 in 2021, and $462,000 in 2020.

It is uncertain if the Company will have taxable profits in the near future to allow all or part of the deferred tax asset to be utilized and as a result, no deferred tax asset was recognized in 2022, 2021, and 2020. The tax reconciliation and the impact of the unrecognized deferred tax assets is as follows:

Thousands of $	Income Statement
Forthe years ended December 31	2022			2021			2020
Loss for the year		(44,044	)		(29,002	)		(28,662	)
Income tax expense		0			0			0
Loss before income tax		(44,044	)		(29,002	)		(28,662	)
Tax using the MDxHealth’s domestic tax rate <br>(25.00% in 2022, 2021, and 2020)		11,011			7,251			7,166
Effect of unused tax losses not recognized as deferred tax assets		(11,011	)		(7,251	)		(7,166	)

NOTE 10: Goodwill

On August 2, 2022, the Company acquired the GPS test from Exact Sciences (refer to Note 3 for further details). The purchase price in excess of the fair value of the net assets acquired has been considered as residual goodwill for an amount of $35.9 million.

The Company is required to test Goodwill for impairment on an annual basis. The recoverable amount is determined based on a value-in-use calculation. The use of this method requires the estimation of future cash flows and the determination of a discount rate in order to calculate the present value of the cash flows.

The company monitors its Goodwill at the consolidated company level, which is the level of cash generating units (CGUs) benefiting from the synergies. The recoverable amount of the CGU has been determined from the value-in-use calculation based on the Company’s cash flow projections covering a period of 5 years through December 31, 2027.

F-23

The amount by which the CGU’s recoverable value exceeds its carrying value is $39.8 million. The changes in the carrying value of Goodwill at December 31, 2022, 2021, and 2020 can be presented as follows:

Thousands of $	Goodwill
At January 1, 2020		-
Additions through business combination		-
Impairment		-
Currency translation adjustments		-
Carrying value at December 31, 2020		-
At January 1, 2021		-
Additions through business combination		-
Impairment		-
Currency translation adjustments		-
Carrying value at December 31, 2021		-
At January 1, 2022		-
Additions through business combination		35,926
Impairment		-
Currency translation adjustments		-
Carrying value at December 31, 2022		35,926

The assumptions used are as follows:

Assumptions used	December 31, 2022
Discount rate (post-tax)		14.95	%
Terminal growth rate		2	%

The discount rate is based on comparable companies in the industry together with company-specific risks. Terminal growth rate is based on management estimates and industry data.

The Company’s impairment review is sensitive to changes in the assumptions used, most notably the discount rate and the terminal growth rate.

An increase of 1% in the discount rate would cause the value-in-use of the CGU to reduce by $12.5 million but would not give rise to an impairment. A 1% reduction in perpetuity growth rate would cause the value-in-use of the CGU to decrease by $8.6 million but would not give rise to an impairment. Based on sensitivity analysis performed at December 31, 2022 , an increase of the post-tax discount rate by 3.86% up to 18.81% would result in the carrying amount exceeding the recoverable amount.

Based on the above information, management concluded that there is no Goodwill impairment in 2022.

NOTE 11: Intangible assets

Thousands of $		****		****		****		****		****
Gross value
At January 1, 2021	5,134		9,323		4,500		-		18,957
Gross value at December 31, 2021	5,134		9,323		4,500		-		18,957
Accumulated amortization and impairment At January 1, 2021	(4,676	)	(6,810	)	(2,413	)	-		(13,899	)
Additions	(234	)	(926	)	(450	)			(1,610	)
Accumulated amortization and impairment at December 31, 2021	(4,910	)	(7,736	)	(2,863	)	-		(15,509	)
Net value at December 31, 2021	224		1,587		1,637		-		3,448
Gross value
At January 1, 2022	5,134		9,323		4,500		-		18,957
Additions			1,049		325				1,374
Additions through business combination (Note 3)					36,550		8,007		44,557
Currency translation adjustments
Gross value at December 31, 2022	5,134		10,372		41,375		8,007		64,888
Accumulated<br> amortization and impairment<br><br> At January 1, 2022	(4,910	)	(7,736	)	(2,863	)	-		(15,509	)
Additions	(224	)	(942	)	(1,490	)	(513	)	(3,169	)
Impairment			(44	)					(44	)
Currency translation adjustments
Accumulated<br> amortization and impairment at December 31, 2022	(5,134	)	(8,722	)	(4,353	)	(513	)	(18,722	)
Net value at December 31, 2022	0		1,650		37,022		7,494		46,166

F-24

Amortization of intangible assets is included in research & development expenses and in selling and marketing expenses in the statement of profit and loss.

The externally acquired intangible asset includes technology acquired in the business combination with NovioGendix in 2015 and with the acquisition of the GPS test in August 2022, and increased by $36.6 million in 2022 due to the GPS acquisition. The estimated remaining amortization period amounts to 2.6 years for the NovioGendix IP and to 14.6 years for the GPS IP.

Customer relationships includes customers acquired in the GPS acquisition, resulting in the fair value at acquisition date of $8.0 million. The GPS Customer relationships are amortized over 6.5 years, the estimated remaining amortization period amounts to 6 years.

The internally-developed intangible assets relate to the capitalized development expenses for Confirm mdx and Select mdx over the past years as well as for the development of the GPS assay in-house and our Resolve mdx assay. The estimated remaining amortization period amounts to 1.2 years for Confirm mdx and Select mdx and 5 years for GPS and 4.3 years for Resolve mdx. In 2022, the Company capitalized $1.0 million (2021: $0; 2020: $0) in GPS and Resolve mdx development expenses.

NOTE 12: Property, plant and equipment and right of-use assets

Property, plant and equipment

Thousands of $
Gross value
At January 1, 2021	5,359		434		504		666		6,963
Additions	255		131		158		675		1,219
Disposals					(2	)			(2	)
Exchange rate difference arising	(329	)	4		13				(312	)
Gross value at December 31, 2021	5,285		569		673		1,341		7,868
Accumulated depreciation At<br> January 1, 2021	(4,874	)	(244	)	(343	)	(529	)	(5,990	)
Additions	(277	)	(64	)	(103	)	(77	)	(521	)
Disposals					2				2
Exchange rate difference arising	334		(7	)	(15	)			312
Accumulated depreciation at December 31, 2021	(4,817	)	(315	)	(459	)	(606	)	(6,197	)
Net value at December 31, 2021	468		254		214		735		1,671
Gross value
At January 1, 2022	5,285		569		673		1,341		7,868
Additions	1,695		104		277		713		2,789
Disposals					(258	)			(258	)
Exchange rate difference arising	88		(4	)	(5	)	4		83
Gross value at December 31, 2022	7,068		669		687		2,058		10,482
Accumulated depreciation At<br> January 1, 2022	(4,817	)	(315	)	(459	)	(606	)	(6,197	)
Additions	(276	)	(72	)	(159	)	(166	)	(673	)
Disposals					258				258
Exchange rate difference arising	(91	)	7		3		2		(79	)
Accumulated depreciation at December 31, 2022	(5,184	)	(380	)	(357	)	(770	)	(6,691	)
Net value at December 31, 2022	1,884		289		330		1,288		3,791

During 2022, the Company acquired $1.7 million of laboratory equipment and $713,000 of leasehold improvements. In 2021, the company also acquired $255,000 of laboratory equipment and $675,000 of leasehold improvements. The primary purpose of these acquisitions was to add testing capacity for its new GPS and Resolve assays.

F-25

Right of-use assets

Thousands of $
Gross value
Balance at January 1, 2021	3,612		218		897		4,727
Additions	1,518						1,518
Disposals
Gross value at December 31, 2021	5,130		218		897		6,245
Accumulated depreciation
Balance at January 1, 2021	(1,177	)	(87	)	(729	)	(1,993	)
Additions	(752	)	(42	)	(111	)	(905	)
Accumulated amortization on December 31, 2021	(1,929	)	(129	)	(840	)	(2,898	)
Net value at December 31, 2021	3,201		89		57		3,347
Gross value
Balance at January 1, 2022	5,130		218		897		6,245
Additions	1,435		58		334		1,827
Exchange rate differences					(1	)	(1	)
Gross value on December 31, 2022	6,565		276		1,230		8,071
Accumulated depreciation
Balance at January 1, 2022	(1,929	)	(129	)	(840	)	(2,898	)
Additions	(945	)	(51	)	(71	)	(1,067	)
Exchange rate differences					(3	)	(3	)
Accumulated amortization on December 31, 2022	(2,874	)	(180	)	(914	)	(3,968	)
Net value at December 31, 2022	3,691		96		316		4,103

In December 2019, the Company entered into a lease agreement (the “Alton lease”) for approximately 11,000 square feet of office space in Irvine, California. In April 2020, the company amended the Alton Lease to add approx. 8,000 additional square feet of adjacent office space. The term of both the Alton lease and the first amendment is for a period of 6 years, and both commenced in September 2020. In March 2021, the Company amended the Alton lease for a second time, in order to renew for an additional 5 years its existing 13,000 square foot laboratory space which was previously part of a separate lease. The commencement date for the second Alton lease amendment was October 2021. Under the terms of the Alton Lease Agreement, the Company has an option to extend the Alton Lease for a period of 5 years. In October of 2021, the company entered into a 35-month lease agreement for 6,000 additional office space adjacent to the laboratory. In June 2022, the company entered into a 36-month lease agreement (the “Plano lease”) for approximately 3,000 square feet of lab space in Plano, Texas with an effective date of June 2022. The Plano lease was amended in November 2022 to add approximately 1,500 square feet of office space. Under the terms of the Plano lease, the lease will automatically renew for successive 12-month periods after the end of the original term of the agreement. Under the terms of the lease agreements mentioned, the rental payments escalate through the term of each agreement and the Company is subject to additional charges for common area maintenance and other costs.

In October 2022, the company renewed its lease agreement for a term of 60 months for its facilities in Nijmegen, The Netherlands.

The new lease agreements from 2022 represent an additional right of use assets of a total value of $1.8 million.

The following amounts related to leases are recognized in the statement of profit or loss:

Thousands of $	2022		2021		2020
Depreciation expense		1,067		905		771
Interest expense on lease liabilities		314		229		93

NOTE 13: Inventories

Thousandsof $ For the years ended December 31	2022		2021
Raw materials and consumables		2,327		1,911
Total Inventories		2,327		1,911

Inventories are recognized at the lower of cost or net realizable value. Inventories recognized as an expense during the year ended December 31, 2022, amounted to $3.6 million (2021: $3.2 million; 2020: $3.0 million). These were included in cost of sales and services.

F-26

NOTE 14: Trade and other receivables

Tradereceivables

Thousandsof $ For the years ended December 31	2022		2021
Trade receivables		9,357		4,582
Total trade receivables		9,357		4,582

Trade receivables mainly consist of claims due from our patients’ insurance companies related to our diagnostic tests.

Considering the Company’s revenue recognition methodology further described in Note 2.7, total accounts receivable balance could be presented in relation with the claim date of each sample as follows:

A/R by claim date	Months
Thousands of $ For the years ended December 31, 2022	1-3<br><br> months		4-6<br><br> months		7-12<br><br> months		Not due		Total
Confirm mdx		1,865		821		765				3,451
Select mdx		134		101		78		25		338
Resolve mdx		1,966		458		158				2,582
GPS		1,907		895						2,802
Other		163						21		184
Total Trade Receivables		6,035		2,275		1,001		46		9,357
A/R by claim date	Months
---	---	---	---	---	---	---	---	---	---	---
Thousands of $ <br><br>For the years ended December 31, 2021	1-3<br><br> months		4-6<br><br> months		7-12<br><br> months		Not due		Total
Confirm mdx		1,644		746		1,256				3,646
Select mdx		151		203		206		33		593
Other		321						22		343
Total Trade Receivables		2,116		949		1,462		55		4,582

Prepaid expenses andother current assets

Thousandsof $ For the years ended December 31
Prepayments	1,710	1,022
Deposits	101	89
Recoverable VAT	97	246
Grants to be received	54	235
Other	0	23
Total prepaid expenses and other current assets	1,962	1,615

Prepaid expenses mainly consist of prepaid insurance premiums and prepaid maintenance contracts.

All financial assets carried at amortized cost are shown net of expected credit losses.

NOTE 15: Cash and cash equivalents

Thousandsof $ For the years ended December 31	**<br><br>2022**		**<br><br>2021**
Cash and cash equivalents		15,503		58,498
Total cash and cash equivalents		15,503		58,498

The bank balances and cash held by the Company and short-term bank deposits have an original maturity of less than 3 months. The carrying amount of these assets approximates their fair value.

The Company had no restricted cash in 2022 and 2021.

F-27

NOTE 16: Loans, Borrowings, Leases obligationsand other financial liabilities

Loans, Borrowings & Lease liabilities

Thousandsof $ For the years ended December 31	**<br><br>2022**		**<br><br>2021**
Non-current loans and borrowings
Loans		34,914		7,651
Lease liabilities (*)		3,091		2,624
Total non-current loans and borrowings		38,005		10,275
Thousands of $ For the years ended December 31	**<br><br>2022**		**<br><br>2021**
---	---	---	---	---
Current loans and borrowings
Loans		616		4,441
Lease liabilities		1,172		840
Total current loans and borrowings		1,788		5,281

(*) the evolution in the right of use assets is further disclosed in note 12.

Innovatus debt facility

On August 2, 2022, the Company entered into a $70 million loan and security agreement with Innovatus Life Sciences Lending Fund I, LP (“Innovatus”), which loan also replaced the Company’s €9 million debt facility with Kreos Capital. At closing, an amount of $35 million was drawn, with an additional $35 million remaining available as a $20 million term B loan and a $15 million term C loan that can be drawn in 2024 and 2025 respectively, subject to certain conditions. The loans are secured by assets of the Group including intellectual property rights. Remaining proceeds of the loans will be used for working capital purposes and to fund general business requirements.

The loans accrue interest at a floating per annum rate equal to the sum of (a) the greater of (i) the prime rate published in The Wall Street Journal in the “Money Rates” section or (ii) 4.00%, plus (b) 4.25%, and require interest-only payments for the initial four years. As contractually agreed, and at the election of the Company, a portion of the interest becomes payable in-kind by adding an amount equal to 2.25% of the outstanding principal amount to the then outstanding principal balance on a monthly basis until August 2, 2025. The loans mature on August 2, 2027. The lenders shall have the right to convert, prior to August 2, 2025, up to 15% of the outstanding principal amount of the loans into ADSs of the Company at a price per ADS equal to $11.21, reflecting a substantial premium to the trading price prior to the announcement of the acquisition. Amounts converted into ADSs of the Company will be reduced from the principal amount outstanding under the loan. Notable fees payable to Innovatus consist of a facility fee equal to 1% of the total loan commitment, due on the funding date of the relevant loans, and an end-of-loan fee equal to 5% of the amount drawn, payable upon final repayment of the relevant loans.

Security has been granted over all assets (including IP rights) owned by the Company and MDxHealth, Inc. The loan agreement contains customary financial covenants and general affirmative and negative covenants, including limitations on our ability to transfer or dispose of assets, change our business, merge with or acquire other companies, incur additional indebtedness and liens, make investments, pay dividends and conduct transactions with affiliates.

The Innovatus debt facility has been accounted for as a hybrid financial instrument which includes a host financial liability as well as an embedded derivative financial instrument being an equity conversion call option at a fixed rate of up to 15% of the aggregate outstanding principal amount through August 2, 2025.

The embedded derivative is not considered to be closely related to the host financial liability given the differences in economics and risks, and as such both are accounted for separately:

●

The host financial liability is recognized at amortized cost applying the effective interest rate method and has been accounted for as non-current loans and borrowings;

●

The embedded derivative convertible (American) call option is recognized at fair value using a binomial tree option pricing model whereby the fair value is based on the actual stock price and the estimated volatility of the Company’s ADS on Nasdaq since the Company’s IPO on November 4, 2021, and through the valuation date. The volatility measured on August 2, 2022, which was the closing date of the Innovatus debt facility, was 62.85% and at December 31, 2022 was 64.82%. Any changes to the fair value of the embedded derivative will be recognized through the statement of profit or loss. The derivative financial instrument has been accounted for as other current financial liabilities.

---

F-28

Kreos debt facility

As part of the new debt facility with Innovatus, the Company’s debt facility with Kreos for an outstanding principal amount of €9 million has been fully repaid in cash during September 2022, for a total amount of $10.8 million. This repayment included the two convertible loans of €180,000 ($185,364) and €202,500 ($208,535) that were not converted by Kreos and that were entered into as part of amendments to the original Kreos debt facility.

The repayment did not include the derivative financial liability for the initial Kreos drawdown fee which had an estimated fair value on December 31, 2022, of $891,000 and is included in Other financial liabilities as a separate financial instrument valued at fair-value through statement of profit or loss. This financial liability is payable upon demand in cash, or convertible into the Company’s common stock, upon election by Kreos.

The financial results largely related to the interest charges for the loan facility with Kreos Capital for a total of $206,000. The amortized cost is calculated using the effective interest method, which allocates interests and expenses at a constant rate over the term of the instrument. The debt extinguishment costs incurred amounted to $1.8 million and are included in the statement of profit or loss under Financial expenses.

During 2019, the Company entered into a loan facility with Kreos Capital in the amount of €9.0 million, or approximately $10.2 million. The loan had a term of four years with the first 12 months of interest-only payments followed by 36 months of principal and interest payments. On October 20, 2020, MDxHealth and Kreos Capital executed an amendment to the 2019 loan facility, extending the interest-only period from 12 months to 18 months. As a result of this amendment, repayment of principal was extended by 6 months, from November 2020 to May 2021. As part of the amendment, the Company agreed to increase the end-of-loan fee by €67,500 (approx. $80,000) as well as to provide for €180,000 of the €9 million loan to be convertible into shares of MDxHealth at a 25% premium to the 30-day volume weighted average price immediately prior to signing the amendment. If exercised, this amount was to be reduced from the principal amount due under the loan agreement.

In April 2021, MDxHealth and Kreos Capital executed a second amendment to the loan facility, extending the interest-only period from 18 months to 27 months. As a result of this amendment, repayment of principal was extended from May 2021 to February 2022. As part of the amendment, the Company agreed to increase the end-of-loan fee by an additional €67,500 (approx. $80,000) as well as to provide for an additional €202,500 of the €9 million loan to be convertible into shares of MDxHealth at a 25% premium to the 30-day volume weighted average price 10 days prior to signing the amendment.

The convertible part of the loan, representing the first discretionary convertible loan of €180,000 ($203,868) and the second discretionary convertible loan of €202,500 ($229,352) were recognized at their amortized cost.

In addition, the second amendment provided for a further six-month extension of the interest-only period if the Company would receive gross proceeds for a minimum amount of $30 million in new equity financing. Following the completion of the Company’s Initial Public Offering of ADSs in the United States on November 8, 2021, whereby the Company received gross proceeds of $45 million in new equity financing, Kreos granted a six-month extension of the interest-only period through July 2022.

In addition, as the loan facility is contracted in Euro, the foreign exchange rate impacts the carrying amount. The amortized cost is calculated using the effective interest method, which allocates interests and expenses at a constant rate over the term of the instrument.

On April 20, 2020, the Company, through its U.S. subsidiary, MDxHealth Inc., has entered into a “Paycheck Protection Program” (PPP) loan with the U.S. Small Business Administration (SBA) in the amount of $2,316,000 as part of the U.S Coronavirus Aid, Relief, and Economic Security (CARES) Act. The loan has a term of five years and carries an interest rate of 1.0% per year. Payments on the loan are deferred for the first eighteen months following disbursement of the loan, with principal and interest payments beginning on the nineteenth month. Interest on the loan continues to accrue during the eighteen-month deferment period. Cash proceeds from the loan were received in July 2020. As of December 31, 2022, the outstanding amount on the PPP loan was $1.6 million.

In addition to the contracted loans, the Company has several lease obligations. The leases have terms of 3 to 5 years.

F-29

Maturity of loans and borrowings are as follows at the balance sheet date:

Thousandsof $ For the years ended December 31
Loans
Within one year	630	4,780
Years two to five	38,439	9,283
Leases
Within one year	1,551	1,127
Years two to five	2,330	3,094

Note: all figures shown in this table areundiscounted and reflect future cash payments (capital and interests)

Other financial liabilities

Thousandsof $ For the years ended December 31
Other financial liabilities
Other non-current<br>financial liabilities	53,537	1,466
Other current financial liabilities	2,327	961
Total other financial liabilities	55,864	2,427

GPS Contingent consideration

As part of the acquisition of the GPS business from Exact Sciences in August 2022, an aggregate earn-out amount of up to $70 million is to be paid by MDxHealth to Exact Sciences upon achievement of certain revenue milestones related to fiscal years 2023 through 2025, with the maximum earn-out payable in relation to 2023 and 2024 not to exceed $30 million and $40 million, respectively. The liability recognized reflects a probability-weighted estimate at the current net present value which is expected to become payable. Future fair value adjustments to this contingent consideration will be recognized in the statement of profit or loss. The value of the contingent liability for GPS including the fair value adjustment accounted for under other non-current financial liabilities is $52.9 million as of December 31, 2022.

Innovatus embedded derivative convertiblecall option

The embedded derivative convertible (American) call option is recognized at fair value within the other non-current financial liabilities and amounts to $910,000 as at December 31, 2022.

Kreos derivative financial instrument (“initialdrawdown fee”)

As of December 31, 2022, the derivative financial liability of the convertible initial drawdown fee payable to Kreos remains outstanding as follows:

●	a<br>drawdown fee of €630,000 ($713,538) is due to Kreos Capital which was not payable in cash but remained outstanding as a “convertible<br>loan” (the “Initial Convertible Loan”).
●	Upon<br>the Expiration Date, the convertible loan will convert automatically into ordinary shares at €0.85 per share.
---	---
●	In<br>lieu of converting the Initial Convertible Loan, Kreos Capital may instead cancel the convertible loan at any time (but before the Expiration<br>Date) after the earlier to occur of (i) a repayment or prepayment in full of the loan, and (ii) sale of the entire issued share capital<br>of MDxHealth. In such case, Kreos Capital will be paid an amount equal to 150% of the principal amount of the Initial Convertible Loan.
---	---

The fair value of the financial derivative related to the initial drawdown fee of the Kreos loan is computed as the sum of the probability-weighted values of the fair values associated with each of the possible outcomes and amounts to $891,000 as of December 31, 2022. The derivative financial instrument is accounted for within other current financial liabilities.

F-30

Other financial liabilities

Other financial liabilities include the contingent consideration related to the acquisition of NovioGendix in 2015 and amounts to $1.2 million of which $526,000 was considered as current. The contingent consideration is valued at fair value through the statement of profit or loss. The fair value of this contingent consideration is reviewed on a periodic basis. The fair value is based on a risk-adjusted future cash flows of different scenarios discounted using an interest rate of 12.16%. The structure of the possible scenarios and the probability assigned to each scenario is reassessed by management at every reporting period and requires judgement from management about the outcome and probability of the different scenarios (refer to Note 26 for further details).

A reconciliation of cash and non-cash movements of loans and borrowings, lease liabilities and other financial liabilities is presented below:

Thousands of $	Loans and <br> borrowings						Other financial <br> liabilities
For the years ended December 31	2022			2021			2022			2021
Beginning balance		12,092			13,097			2,427			1,599
Cash movements
Loans and borrowings repaid^1^(Kreos / PPP)		(10,805	)
Loans and borrowings received (Innovatus)		34,291
Non-cash movements
GPS Contingent Consideration								50,483
Reclassification^2^					(773	)					773
Recognition of Innovatus embedded derivative convertible call option		(1,026	)					1,026
Kreos effective interest rate adjustment and extinguishment costs		1,328			536						194
Innovatus - effective interest rate adjustment		660
Foreign exchange rate impact / other		(1,010	)		(768	)		(35	)		(59	)
Fair value changes through profit and loss								1,963			(80	)
Ending balance		35,530			12,092			55,864			2,427
1)	The amount includes interest paid on loans and borrowings
---	---
2)	Reclassification of the fair value of the derivative financial liability of the initial drawdown fee to be presented separately
---	---

Fair value adjustments recognized during 2022 for other financial liabilities relate to:

Thousands of $<br> For the years ended December 31	**<br><br>2022**
Decrease of contingent consideration Noviogendix		(632	)
Increase of Kreos derivative financial instrument (“initial drawdown fee”)		116
Increase of GPS contingent consideration		2,398
Decrease of Innovatus embedded derivative convertible call option		(116	)
Total fair value adjustment		1,766
Thousands of $	Lease liabilities					****
---	---	---	---	---	---	---
For the years ended December 31	2022		****	2021		****
Opening balance		3,464			2,774
Cash movements
Repayment of lease liabilities		(1,358	)		(1,057	)
Non-cash movements
Interest accretion		314			229
New leases		1,843			1,518
Closing balance		4,263			3,464

NOTE 17: Contractual obligations

Thousands of $ For The Years ended December 31
Outstanding commitments for future minimum rent payments, which fall due as follows:
Less than one year	156	215
Years 2-5	60	39
Total contractual obligations	216	254

For 2022 and 2021, we refer to note 12 and 16 for the lease liabilities subsequent adoption and application of IFRS 16.

F-31

Outstanding commitments for future minimum rent payments include rental fees related to leased facilities, and equipment for assets with a value below $5,000 or with short-term duration. These lease contracts can be terminated early with certain indemnity fees. All figures shown assume that the lease contracts will not be terminated early.

NOTE 18: Trade and other payables

Tradeaccounts payable

Thousands of $<br> For The Years ended December 31
Trade accounts payable	5,061	3,192
Accruals for invoices to be received	5,117	4,263
Total trade accounts payable	10,178	7,455

Othercurrent liabilities

Thousandsof $ For The Years ended December 31
Payroll	3,932	2,703
Other accruals	53	32
Total other current liabilities	3,985	2,735

NOTE 19: Financial instruments and fairvalue

The table shows the Company’s significant financial assets and liabilities. All financial assets and liabilities are carried at amortized cost with the exception of the contingent considerations in relation to acquisitions and derivative financial instruments reported at fair value through the statement of profit or loss.

All financial assets and liabilities are considered to have carrying amounts that do not materially differ from their fair value.

Thousands of $<br> For The Years ended December 31
Assets
At amortized cost
Trade receivables	9,357	4,582
Cash and cash equivalents	15,503	58,498
Total financial assets	24,860	63,080
Liabilities
At fair value:
Other financial liabilities
- GPS contingent consideration	52,881		Level 3
- NovioGendix contingent consideration	1,182	1,617	Level 3
- Innovatus derivative instrument	910		Level 3
- Kreos derivative instrument	891	810	Level 3
Subtotal financial liabilities at fair value	55,864	2,427
At amortized cost:
Loans and borrowings	35,530	12,092	Level 2
Lease liabilities	4,263	3,464
Trade payables	10,178	7,455
Subtotal financial liabilities at amortized cost	49,971	23,011
Total financial liabilities	105,835	25,438

F-32

Recognized fair value measurements – valuation techniqueand principal inputs

The fair value of the financial instruments has been determined on the basis of the following methods and assumptions:

●	The<br>carrying value of the cash and cash equivalents, the trade receivables, other current assets and the trade payables approximate their<br>fair value due to their short-term character;
●	The<br>fair value of loans and borrowings applying the Effective Interest Rate method approximates their carrying value (level 2).
---	---
o	Innovatus debt facility: the host financial liability was obtained with a variable interest rate based upon the Prime Rate (with a floor of 4% and a margin of 4.25%)
---	---
o	Paycheck Protection Program (PPP): applying a market rate would not result in a materially different fair value which carries an interest rate of 1% and was obtained as part of the U.S Coronavirus Aid, Relief, and Economic Security (CARES) Act.
---	---
o	Kreos debt facility: the Kreos loan was obtained at the end of 2019 with a nominal fixed interest rate of 9.5%, however, the carrying value is considered to approximate their fair value considering:
---	---
■	Additional<br> contractually agreed advance and post payments agreed upon with Kreos that have been integrated<br> in the effective interest rate method;
---	---
■	During<br> 2020 and 2021, the Company and Kreos negotiated modification to the original agreement resulting<br> in additional consecutive interest-only periods. As compensation for these modifications,<br> part of the loan amounts became convertible as described in Note 16, however the Company<br> and Kreos agreed to maintain nominal fixed interest rate in line with the initial agreement.
---	---
■	Given<br> repayment of the Kreos facility during 2022, no fair value assessment was performed as of<br> December 31, 2022
---	---
●	Leases<br> are measured at the present value of the remaining lease payments, using a discount rate<br> based on the incremental borrowing rate at the commencement date of these leases. Their fair<br> value approximates their carrying value.
---	---
●	The fair value of contingent consideration payable to NovioGendix (presented<br>in the yearend statement of financial position under “other non-current financial liabilities” and “other current financial<br>liabilities”) and Exact Sciences is based on an estimated outcome of the conditional purchase price/contingent payments arising<br>from contractual obligations (level 3). This is initially recognized as part of the purchase price and subsequently fair valued with changes<br>recorded through other operating income in the statement of profit or loss.
---	---
o	NovioGendix: the Company used a discount rate of 12.16%. A net positive fair value<br>measurement of $435,000 was recognized in the 2022 consolidated financial statements, of which $632,000 in operating income and $197,000<br>in financial expense.
---	---
o	GPS: The fair value of the contingent consideration payable to Exact Sciences<br>is based on a probability-weighted average estimate based on multiple scenarios varying in timing and amount of earn-out payment. This<br>probably-weighted estimate is then discounted to its net present value taking into account expected time when earn-out would become payable<br>in 2024, 2025 and 2026. This contingent consideration was initially recorded along with the purchase price allocation of this business<br>combination as explained in Note 3. A fair-value adjustments resulting in a financial charge of $ 2.4 million has been recorded as of<br>December 31, 2022. The Company used a discount rate of 14.95%
---	---
●	The fair value of the derivative financial liabilities related to the initial Kreos drawdown fee of €630,000 ($672,000) is based upon the evolution of the share price of MDxHealth as well as the estimated probabilities that either payment at 150% or conversion will be requested by Kreos. Whereas share price of MDxHealth can be considered as a level 1 input, the other variable, being the probability assessment of possible scenarios should be considered as level 3 input. The fair value of the liability is estimated at $891,000 for the year ended December 31, 2022.
---	---
●	The fair value of the derivative financial liabilities related to the Innovatus derivative call option (as detailed in Note 16) was performed using a binomial pricing model which takes into account several factors including the expected evolution in price of an ADS and are considered as level 3 input. The fair value of the liability is estimated at $910,000 for the year ended December 31, 2022.
---	---
●	Financial<br> instruments are evaluated based on the mark-to-market report and the unrealized gains (loss)<br> are recognized through the statement of profit or loss.
---	---

F-33

Fair value hierarchy:

The Company uses the following hierarchy for determining and disclosing the fair value of financial instruments by valuation technique:

●	Level 1: quoted prices in active markets for identical assets and liabilities;
●	Level 2: other techniques for which all inputs which have a significant effect on the recorded<br> fair value are observable, either directly or indirectly; and
---	---
●	Level 3: techniques which use inputs that have a significant effect on the recorded fair value<br> that are not based on observable market data.
---	---

No financial assets or financial liabilities have been reclassified between the valuation categories during the year.

A reconciliation of cash and non-cash movements of level 3 financial liabilities is presented below:

Thousands of $	Financial Derivative Instruments (Kreos and Innovatus)						Contingent Consideration (NovioGendix and GPS)
For the years ended December 31	2022			2021			2022		2021
Beginning balance		810			0			1,617		1,599
Cash movements
Loans and borrowings repaid
Non-cash movements
GPS contingent consideration								50,483
Innovatus embedded derivative convertible call option		1,026
Reclassification^1^					773
Effective interest rate adjustment
Foreign exchange rate impact / other movements		(35	)		(59	)
Fair value changes through profit and loss					96			1,963		18
Ending balance		1,801			810			54,063		1,617
1)	Reclassification of the fair value of the derivative financial<br>liability of the initial drawdown fee to be presented separately
---	---

NOTE 20: Loss per share

The basic loss per share is calculated by dividing the net result attributable to shareholders by the weighted average number of shares outstanding during the year.

Years<br>ended December 31			2021			2020
Loss for the year, in thousands of	(44,044	)		(29,002	)		(28,662	)
Basic and diluted loss per share, in	(0.28	)		(0.24	)		(0.34	)

All values are in US Dollars.

Weightedaverage number of shares	2022		2021		2020
Weighted average number of shares for basic and diluted loss per share		158,658,165		121,935,741		83,199,215

At December 31, 2022, 2021, and 2020, the Company had potential dilutive shares in the form of warrants, contingent considerations and convertible loans (see Note 16 for further details). Diluted loss per share considers the impact of potentially dilutive securities except in periods in which there is a loss because the inclusion of the potential common shares would have an anti-dilutive effect.

NOTE 21: Financial Risk Management

Capitalmanagement

Capital is comprised of equity attributable to shareholders, borrowings, and cash and cash equivalents. The Company aims to maintain a strong capital base in order to maintain investor and creditor confidence and to sustain the future development of the business. The Company’s objectives when managing capital are to maintain sufficient liquidity to meet its working capital requirements, fund capital investment and purchases, and safeguard its ability to continue operating as a going concern. The Company monitors capital regularly to ensure that the statutory capital requirements are met and may propose capital increases at shareholders’ meetings to ensure the necessary capital remains intact.

F-34

Creditrisk

At the end of 2022, the Company operated with more than 1,000 different customers, systematically reducing credit risk compared to prior periods.

In the U.S. healthcare system, and particularly within the molecular diagnostic CLIA laboratory industry, where there are rapid technological advances in diagnostic services, companies provide services to healthcare professionals and their patients, while being reimbursed from commercial and governmental insurance systems. Often these services are provided out of network and without supplier contracts. As a result, there is reimbursement risk, separate from credit risk that is characterized by uncertainty in reimbursement value, delays in payment, and ultimately non-payment. This impacts the Company’s revenue recognition and cash collections.

Customer’s compliance with agreed credit terms is regularly and closely monitored. Trade accounts receivable amounted to $9.4 million as of December 31, 2022, and no allowance for expected credit loss was recorded. No ECL has been recorded for other financial assets carried at amortized cost as there is no related credit risk.

The credit risk on cash and cash equivalents of $15.5 million is limited given that the counterparties are banks with high credit scores attributed by international rating agencies. The Company had no exposure to Silicon Valley Bank, Silvergate Bank, or Credit Suisse.

Interestrisk

During 2022, the Company entered into a 60-month loan with Innovatus for a total amount of $35 million (refer to Note 16 for further details). The loan accrues interest at a floating per annum rate equal to the sum of (a) the greater of (i) the Prime rate published in The Wall Street Journal in the “Money Rates” section or (ii) 4.00%, plus (b) 4.25%, and require interest-only payments for the initial four years. For every increase of 0.25% in the Prime rate, the Company’s interest expense increases by approximately $90,000 per year.

In addition, on April 20, 2020, the Company, through its U.S. subsidiary, MDxHealth Inc., has entered into a “Paycheck Protection Program” (PPP) loan with the U.S. Small Business Administration (SBA) in the amount of $2,316,000 as part of the U.S Coronavirus Aid, Relief, and Economic Security (CARES) Act. The amortized cost is calculated using the effective interest method, which allocates interests and expenses at a constant rate over the term of the instrument; the effective interest rate for the loan is 1.00%. Considering the fixed interest rate, the Company is not exposed to interest risk, thus did not perform any sensitivity analysis.

Currencyrisk

The functional currency changed from the EURO to the U.S. Dollar as of July 1, 2014. Consequently, the currency risk is concentrated on European operations.

As of December 31, 2022, cash deposits in EURO amounted to €1.1 million.

The Company performed a sensitivity analysis of an increase/decrease of exchange rate on operations of 10%. The exposure of operations to the currency risk is immaterial given the limited size of the European operations and contribution to revenues versus the Company as a whole.

F-35

Liquidityrisk

The Company manages liquidity risk by maintaining adequate reserves and by continuously monitoring forecast and actual cash flows and matching the maturity profiles of financial assets and liabilities. At the date of this report, the Company has 2 loan agreements with banks and state institutions, and 11 leases (see Notes 12 and 16).

For the years ended December 31, 2022<br> <br>Thousands of $	Less than<br><br> 1 year		between 1<br><br> and 2<br><br> years		between 3<br><br> and 5<br><br> years		Total<br><br> contractual<br><br> cash<br><br> flows		Carrying<br><br> amount
Non derivatives
Trade payables		10,178						10,178		10,178
Loans		630		630		37,809		39,069		35,530
Lease liabilities		1,324		915		2,179		4,418		4,263
Total		12,132		1,545		39,988		53,665		49,971
For the years ended December 31, 2021<br> <br>Thousands of $	Less than<br><br> 1 year		between 1<br><br> and 2<br><br> years		between 3<br><br> and 5<br><br> years		Total<br><br> contractual<br><br> cash flows		Carrying<br><br> amount
---	---	---	---	---	---	---	---	---	---	---
Non derivatives
Trade payables		7,455						7,455		7,455
Loans		4,780		8,200		1,083		14,063		12,092
Lease liabilities		1,127		915		2,179		4,221		3,464
Total		13,362		9,115		3,262		25,739		23,011

Note: Except for carrying amount, all figures shown in this tableare undiscounted and reflect future cash payments

The Company is also committed to a potential additional cash out of:

●	€945,000<br>($1.0 million) if Kreos requests payment in cash of the derivative financial liabilities related to the initial Kreos drawdown fee (see<br>Note 16).
●	an aggregate earn-out amount of up to $70 million that could become payable in cash by MDxHealth to Exact Sciences upon achievement of certain revenue milestones related to fiscal years 2023 through 2025 and payable during 2024 through 2026.
---	---

Otherrisks

The Company subscribes to certain insurance policies to cover matters such as (i) fire, theft, and other damage to its assets, (ii) product and liability insurance and clinical trial insurance, and (iii) D&O insurance. To date, no significant claims have been made under these insurance policies and there is no guarantee that the insurances will cover all damages if they should ever occur.

NOTE 22: Share capital and reserves

At December 31, 2022, the Company’s share capital was represented by the following number of shares (units). Only one class of shares (common shares) exists and they have no par value.

Forthe Years ended December 31	2022		2021
Common shares		162,880,936		155,969,226
Total outstanding shares		162,880,936		155,969,226

On January 21, 2021, the company announced the successful pricing of its capital increase with the offering of new ordinary shares. The Company raised €25.0 million ($30.4 million) in gross proceeds by means of a private placement of 27,777,777 new shares at an issue price of €0.90 per share through an accelerated bookbuild offering. As a result of the issuance of new shares, the Company’s share capital increased from €68,998,734.95 to €90,132,067.69 and its issued and outstanding shares increased from 90,691,449 to 118,469,226 ordinary shares.

On November 8, 2021, the Company announced that completion of a capital increase by means of an initial public offering in the United States of 3,750,000 ADSs at an issue price of $12 per ADS, resulting in gross proceeds of $45.0 million. As a result of this capital increase, its share capital has increased from €90,132,067.69 to €118,662,067.69 and the number of issued and outstanding shares has increased from 118,469,226 to 155,969,226 ordinary shares, through the issuance of a total of 37,500,000 new shares.

F-36

On August 11, 2022, to settle a portion of the purchase price for the acquisition by the Company of the GPS test from Genomic Health, Inc. (a subsidiary of Exact Sciences Corporation) announced on August 2, 2022, the Company issued 691,171 American Depositary Shares, or “ADSs” (each representing 10 ordinary shares of the Company with no nominal value per share), at a price per ADS of $7.23, totaling $5 million. As a result, the Company’s share capital has increased from €118,662,067.69 to €123,539,165.19 and the number of issued and outstanding shares has increased from 155,969,226 to 162,880,936 ordinary shares.

	Thousands of			Thousands of
For the Years ended December 31	Share<br> Capital	Issuance<br><br> Premium		Share<br> Capital	Issuance<br><br> Premium
As of January 1, 2021			136,349			112,078
January 2021 – Issuance of 27,777,777 shares (*)			4,693			3,867
November 2021 – Issuance of 37,500,000 shares (*)			12,135			10,536
As of December 31, 2021			153,177			126,481
August 2022 – Issuance of 6,911,710 shares (*)
As of December 31, 2022			153,177			126,481

All values are in US Dollars.

(*) net of expenses

The capital stock and the issuance premium amounted to the following:

	Thousands of					Thousands of
For the Years ended December 31	2022		2021			2022		2021
Share Capital as per statutory accounts				143,419					118,662
Capital increase costs		)		(14,965	)		)		(12,564	)
Share capital under IFRS				128,454					106,098
Issuance premium				153,177					126,481
Share capital and issuance premium				281,631					232,579

All values are in US Dollars.

The history of the Share Capital can be found in “General Information; Capital and Shares”.

By virtue of the resolution of the extraordinary general shareholders’ meeting of the Company held on May 27, 2021, which entered into force on June 1, 2021, the board of directors of the Company has been granted certain powers to increase the Company’s share capital in the framework of the authorized capital. The powers under the authorized capital have been set out in article 6 of the Company’s articles of association.

Pursuant to the authorization granted by the extraordinary general shareholders’ meeting, the board of directors was authorized to increase the share capital of the Company on one or several occasions by a maximum aggregate amount of EUR 90,132,067.69 (excluding issue premium, as the case may be) for a period of 5 years as from June 1, 2021.

The board of directors has used its powers under the authorized capital on (i) November 8, 2021, by issuing 37,500,000 new shares (3,750,000 ADSs) for an aggregate amount of €28,530,000.00 (excluding issue premium), and (ii) August 11, 2022, by issuing 6,911,710 new shares (691,171 ADSs) for an aggregate amount of €4,877,097.50. Moreover, subsequent to the balance sheet date (and as described further in Note 27), the board of directors has used its powers under the authorized capital at the occasion of the February 2023 capital increase. As a result, the board of directors therefore still has the authority under the authorized capital to increase the Company’s share capital with an aggregate amount of €16,792,505.80 (excluding issue premium, as the case may be).

In addition to the outstanding shares of the Company:

●

a total of 13,895,280 subscription rights of the Company have been created, of which 12,257,780 subscription rights have been granted as of December 31, 2022, which entitles their holders (assuming all subscription rights are granted and exercised) to subscribe to a total of 12,257,780 new shares with voting rights (see Note 24 for further details). The remaining 1,637,500 subscription rights have not yet been granted and are currently still managed by the Company’s board of directors;

●

under the loan agreement entered into by the Company and Kreos Capital in July 2021, a drawdown fee equal to 7% of the amounts drawn down under the loan agreement (being EUR 630,000 in aggregate) remains outstanding as a payable due by the Company (without accruing interest), and is convertible into ordinary shares with voting rights by means of a contribution in kind of the payable by Kreos Capital to the share capital of the Company at a price of €0.85 per share (see Note 24 for further details); and,

---

F-37

●

under the loan and security agreement entered into by the Company and Innovatus Capital Partners in August 2022, Innovatus has the right to convert, prior to August 2, 2025, up to 15% of the outstanding principal amount of the loans (by means of a contribution in kind of the relevant payables due by the Company under the loans) into American Depositary Shares (“ADSs”) of the Company (each representing 10 ordinary shares of the Company) at a conversion price per ADS equal to $11.21 (i.e., $1.121 per share on the basis of the ratio of 1 ADS per 10 shares) (see note 16 for further details).

NOTE 23: Retirement benefit plans

The Company operates defined contribution plans for all its qualifying employees. The assets of these plans are held separately from those of the Company in designated funds.

A total cost of $724,000 in 2022 (2021: $594,000) represents contributions payable to these plans by the Company at rates specified in the rules of the plans.

The employees of the Company in Belgium are members of a state-managed retirement benefit plan operated by the government (i.e., legal pension) and are members of a bank-operated private pension plan. The Company is required to contribute a specified percentage of payroll costs to the retirement benefit plan to fund the benefits. The obligation of the Company with respect to the retirement benefit plan is to make the specified contributions.

Because the Company must guarantee the statutory minimum return on these plans, not all actuarial and investment risks relating to these plans are transferred to the insurance company or pension fund managing the plans. The Company has considered the potential impact of the employer’s obligation to guarantee a minimum return and that this was assessed not to be significant.

NOTE 24: Share-based payments

This section provides an overview of the outstanding warrants as of December 31, 2022. The warrants were created within the context of stock-based incentive plans for employees, directors and consultants of the Company.

The Company has created several pools of warrants under stock option plans for grant to eligible employees, Directors, and consultants. On March 15, 2012 (195,000), June 15, 2012 (700,000), June 23, 2014 (1,500,000), June 19, 2017 (2,500,000), June 21, 2019 (3,000,000), May 27, 2021 (3,600,000) and May 25, 2022 (5,000,000). In aggregate 17,310,800 warrants were issued, subject to warrants being granted to and accepted by the beneficiaries. 18,150 of these warrants never allocated have become null and void, resulting in a remaining and outstanding 17,296,650 warrants, (i) 2,840,397 warrants were terminated or lapsed, (ii) 577,123 warrants were exercised, (iii) 12,257,780 warrants were granted but not yet exercised, and (iv) 1,637,500 warrants were not yet granted by the Company. For the year 2022, 590,345 warrants (2021: 304,968) were terminated or lapsed, no warrants were exercised, and 2,127,021 warrants (2021: 795,250) were vested. As a result, as at December 31, 2022, there are 12,257,780 warrants outstanding, entitling their holders to subscribe to 12,257,780 shares of the Company.

Number of potential shares from outstanding warrants
As of January 1	8,917,625		5,766,093
Number of warrants cancelled/forfeited during the year	(590,345	)	(304,968	)
Number of warrants granted during the year	3,930,500		3,456,500
As of December 31	12,257,780		8,917,625

The warrants are granted to employees (mainly), consultants or directors of the Company and its subsidiaries. Each warrant entitles its holders to subscribe to one new share of the Company at a subscription price determined by the board of directors, within the limits decided upon at the occasion of their issuance.

The warrants issued have generally a term of ten years as of issuance. Upon expiration of their term, the warrants become null and void.

F-38

In general, the warrants vest in cumulative tranches of 25% per year, provided that the beneficiary has provided at least one year of service. However, there are certain exceptions to this rule which are, if applicable, specified in the relevant stock option plans. The warrants granted under the June 23, 2014 Stock Option Plan to directors all vest on the date of the annual meeting that takes place in the calendar year following the calendar year in which they were granted, provided that the mandate of the relevant director has not ended or been terminated. The warrants granted under the June 23, 2014 Stock Option Plan to beneficiaries who are not directors all vest in instalments of 25% per year, the first tranche of 25% vesting on the first anniversary date of the date of grant and the following tranches vesting on a quarterly basis. The warrants granted under the June 21, 2019 Stock Option Plan, the May 27, 2021 Stock Option Plan and under the May 25, 2022 Stock Option Plan to specific beneficiaries (Directors and Management Team) may adopt a manual vesting procedure under certain conditions or a particular vesting period over 3 years.

The table below presents the outstanding warrants and their exercise price at the end of each accounting year covered by the financial statements:


Granted in 2021	3,456,500	3,456,500
Outstanding 31 December 2021	8,917,625	8,917,625
Granted in 2022	3,930,500	3,930,500
Outstanding 31 December 2022	12,257,780	12,257,780
Exercisable at 31 December 2022	5,220,520	5,220,520

All values are in Euros.

The following table provides an overview of the outstanding potential shares from warrants per personnel category at December 31, 2022 and 2021:

Category
Executive Director	3,950,000	2,950,000
Non-Executive Directors	248,000	272,000
Management team (excluding the Executive Director)	4,083,000	2,938,000
Other employees, consultants, and former service providers	3,976,780	2,757,625
Total outstanding at December 31	12,257,780	8,917,625

The share-based compensation expense recognized in the statement of comprehensive income is given below as is the cumulated amount per the consolidated statement of financial position:

Thousandsof $ Years ended December 31	**<br><br>2022**		**<br><br>2021**		2020
Share-based compensation		867		1,222		1,295
Cumulated Share-based compensation		11,474		10,607		9,385

The Cumulated Share-based compensation amount is part of the Total Shareholders’ Equity on the Consolidated statement of financial position. This amount is presented on the Consolidated statement of financial position for both exercised and non-exercised warrants.

The weighted average exercise price of all outstanding warrants (vested and non-vested warrants; assuming 1 warrant = 1 share) is €1.23 or $1.32 at December 31, 2022 (€1.53 or $1.73 at December 31, 2021; €1.74 or $2.14 at December 31, 2020). The weighted average remaining contractual life of all outstanding warrants at the end of 2022 is 7.31 years (2021: 7.18 years; 2020: 6.70 years).

F-39

The fair value of each warrant is estimated on the date of grant using the Black-Scholes methodology with the following assumptions:

	Number of warrants granted					Expected		Expected			Risk-free			Expected duration (months)
Dates	to Belgian benef.		to other benef.		Exercise price ()	dividend Yield		stock price volatility			interest rate			to Belgian benef.		to other benef.
23-Jun-14		12,000		12,000			-		48.12	%		1.78	%		75.32		63.29
9-Feb-15		60,000		95,000			-		46.75	%		0.62	%		79.73		61.71
29-May-15		20,000		30,000			-		46.52	%		0.81	%		64.14		52.11
1-Oct-15		-		83,000			-		48.99	%		0.90	%		72.03		54.02
1-Dec-15		-		18,000			-		51.18	%		0.85	%		70.03		52.01
1-Feb-16		-		10,000			-		51.18	%		0.85	%		67.99		49.97
4-Feb-16		50,000		134,000			-		52.49	%		0.72	%		67.89		49.87
2-Apr-16		-		52,000			-		53.40	%		0.58	%		65.33		53.33
29-May-16		30,000		40,000			-		51.85	%		0.54	%		64.11		52.11
22-Jan-16		-		20,000			-		52.81	%		0.86	%		68.32		56.32
1-Dec-16		-		22,000			-		54.16	%		0.75	%		57.99		39.98
1-Jan-17		-		19,000			-		53.84	%		0.73	%		56.98		50.96
1-Apr-17		-		18,000			-		51.80	%		0.81	%		54.02		48.00
11-Apr-17		20,000		200,000			-		51.83	%		0.72	%		65.68		47.67
29-Jul-17		-		10,000			-		50.95	%		0.87	%		50.10		44.05
1-Sep-17		-		34,000			-		48.08	%		0.71	%		60.99		42.97
2-Nov-17		-		99,000			-		45.23	%		0.66	%		52.93		40.90
20-Jun-17		30,000		30,000			-		51,57	%		0.59	%		81.40		63.39
01-Apr-18		-		42,000			-		46.08	%		0.76	%		54.02		42.02
01-Jun-18		50,000		30,000			-		46.15	%		0.77	%		52.01		40.01
05-Dec-18		-		20,000			-		57.56	%		0.79	%		45.86		33.86
24-Jan-19		-		191,000			-		67.56	%		0.77	%		62.24		50.20
16-May-19		-		1,508,000			-		75.78	%		0.38	%		58.55		46.52
01-Nov-19		-		8,000			-		82.15	%		0.00	%		64.99		46.98
01-Dec-19		-		12,000			-		81.95	%		0.00	%		64.01		45.99
01-Feb-20		-		2,000			-		80.26	%		0.00	%		61.97		49.67
01-Jun-20		-		6,000			-		86.64	%		0.00	%		57.99		45.99
01-Oct-20		-		2,000			-		85.20	%		0.00	%		53.95		35.97
15-Jul-20		-		225,000			-		85.89	%		0.00	%		56.51		38.53
01-Jul-19		60,000		20,000			-		78.70	%		0.07	%		69.01		51.02
24-Jul-19		-		980,000			-		78.64	%		0.00	%		68.25		50.27
15-Jul-20		-		1,598,000			-		85.89	%		0.00	%		56.52		38.53
30-Jul-20		20,000		-			-		87.02	%		0.00	%		56.02		38.04
01-Oct-20		-		10,000			-		85.20	%		0.00	%		53.95		35.97
01-Mar-21		-		2,000			-		65.06	%		0.00	%		48.99		31.00
03-May-21		-		8,000			-		64.59	%		0.01	%		46.92		28.93
01-Jun-21		-		4,000			-		65.82	%		0.01	%		45.96		27.98
27-Jul-21		-		30,000			-		63.36	%		0.00	%		44.12		26.14
27-Jul-21		-		202,500			-		63.36	%		0.00	%		44.12		26.14
24-Nov-21		-		40,000			-		60.78	%		0.14	%		49.25		37.25
03-Jul-21		-		2,570,000			-		63.10	%		0.04	%		44.91		26.93
07-Jul-21		-		600,000			-		63.11	%		0.00	%		44.78		26.79
06-May-22		-		5,000			-		53.16	%		1.64	%		58.85		52.87
04-Aug-22		-		38,000			-		55.63	%		1.41	%		55.89		49.91
03-Aug-22		-		425,000			-		57.05	%		1.50	%		67.96		55.92
03-Aug-22		-		3,125,000			-		57.05	%		1.50	%		73.97		61.94
04-Aug-22		-		10,000			-		55.63	%		1.41	%		73.94		61.91
01-Oct-22		-		312,500			-		57.26	%		2.77	%		72.03		60.00
12-Dec-22		-		15,000			-		58.30	%		2.40	%		69.67		63.65

All values are in Euros.

F-40

The above inputs for the Black-Scholes model have been determined based on the following:

●	The<br>dividend return is estimated by reference to the historical dividend payment of the Company. Currently, this is estimated to be zero<br>as no dividends have been paid since inception.
●	The<br>expected volatility was determined using the average volatility of the stock over the last two years at the date of grant.
---	---
●	Risk-free<br>interest rate is based on the interest rate applicable for the 10Y Belgian government bond at the grant date
---	---

NOTE 25: Related parties

Transactions between the Company and its employees, consultants or Directors are described below. There were no other related party transactions.

Remunerationof key management personnel

During the year ended December 31, 2022, the executive management team included four members:

Chief Executive Officer, Mr. Michael McGarrity
Executive Vice President of Corporate Development & General Counsel, Mr. Joseph Sollee
Chief Financial Officer, Mr. Ron Kalfus
Chief Commercial Officer, Mr. John Bellano

Their combined remuneration package, including employer taxes, amounted to the following:

Thousands of $<br> <br>except per personnel, warrants & share amounts<br> <br>ForThe Years ended December 31
Number of management members and Executive Directors	4	4	4
Short-term employee benefits	1,550	1,545	1,535
Post-employment benefits	54	52	23
Other employment costs	219	207	174
Total benefits	1,822	1,804	1,732
IFRS share-based compensation expense	863	982	596
Number of warrants offered	2,200,000	2,200,000	1,183,000
Cumulative outstanding warrants	8,088,000	5,888,000	3,688,000
Exercisable warrants	3,618,642	1,282,238	1,036,250

The following table sets forth the number of warrants that were exercised, granted and accepted in aggregate by the four members of the executive management team:

	2022		2021		2020
Number of warrants exercised		0		0		0
Number of new warrants granted and accepted		2,200,000		2,200,000		1,183,000
Annualized IFRS cost for existing warrants	$	863,000	$	982,000	$	596,000

No loans, quasi-loans or other guarantees are outstanding with members of the executive management team.

F-41

Remunerationof the Board

The total remuneration of the Board of Directors (including the Executive Director) in 2022, 2021, and 2020 was $876,000, $863,000, and $775,000, respectively (excluding VAT, stock-based compensation and reimbursement of expenses). No advances or credits have been granted to any member of the Board of Directors. None of the members of the Board of Directors have received any non-monetary remuneration other than warrants as disclosed above.

Transactions with Non-ExecutiveDirectors

Since 2012, the Non-Independent Directors do not receive a fee payment for attending and preparing for Board meetings or for assisting the Company with Board matters. They receive reimbursement for expenses directly related to the Board meetings, totaling less than $23,000 in 2022.

The Independent Directors receive a fee for attending and preparing meetings of the Board of Directors and for assisting the Company with Board matters, and they receive reimbursement for expenses directly related to the Board meetings. In 2022, 2021, and 2020, fees and expense reimbursement in the amount of $314,000, $302,000, and $231,000, respectively, were paid to independent members of the Board of Directors.

No warrants were granted to Non-Executive Directors in 2022 and no warrants were exercised in 2022.

NOTE 26: Significant agreements, commitmentsand contingencies

Fairvalue of Other financial liabilities

On September 18, 2015, MDxHealth acquired MDxHealth BV (former NovioGendix), a Dutch molecular diagnostic research and service company with expertise in the urological oncology. The terms of the acquisition consisted of initial consideration paid in 1,086,956 shares of MDxHealth common stock, issued at €4.14 representing the average closing price of the Company’s shares on Euronext Brussels during a period of 30 days ending on September 17, 2015. In addition to this equity, additional cash consideration of €250,000 was paid. On top of the acquisition price, MDxHealth is committed to pay future milestone fees. The Company paid €1.0 million, being $1 million regarding these milestone fees in 2017. The Company is contractually required to pay at maturity to the holder of the obligation the amount of maximum $2.2 million. Based on its judgement and estimates, the management believes future milestones will be paid in 2023 and 2024. The fair value of this contingent consideration as of December 31, 2022 is estimated at $1.2 million over the period 2022-2023 (2021: $1.6 million) and was accounted for as other financial liabilities (current and non-current) as detailed in Note 16.

As part of the acquisition of the GPS business from Exact Sciences in August 2022, an aggregate earn-out amount of up to $70 million is to be paid by MDxHealth to Exact Sciences upon achievement of certain revenue milestones related to fiscal years 2023 through 2025, with the maximum earn-out payable in relation to 2023 and 2024 not to exceed $30 million and $40 million, respectively. The contingent consideration has been assessed at $50.5 million which has been accounted for under other non-current liabilities as further detailed in Note 3. The liability recognized reflects a probability-weighted estimate at the current net present value which is expected to become payable. Future fair value adjustments to this contingent consideration will be recognized in the statement of profit or loss. The value of the contingent liability for GPS is $52.9 million as of December 31, 2022, and was accounted for as other non-current financial liabilities as detailed in Note 16.

F-42

Collaborativeresearch agreements and clinical research agreements

The Company has entered into numerous agreements with universities, medical centers and external researchers for research and development work and for the validation of the Company’s technology and products. These agreements typically have durations of one to three years. The Company must pay fixed fees to the collaborators and in exchange typically receives access and rights to the results of the work.

MDxHealth collaborates on research and clinical development with many of the world’s leading academic and government cancer research institutes. These important relationships provide the Company with additional resources and expertise for clinical marker validation as well as access to patient samples for testing. MDxHealth’s collaborators include such prestigious institutions as Johns Hopkins University Medical Institutions (US), Duke University Medical Center (US), Harvard Medical School (US), Cleveland Clinic (US), University of Colorado (US) and University of California at Los Angeles (US) among others.

Intellectualproperty in-licensing agreements

The Company has entered into numerous agreements with universities and companies for in-licensing intellectual property. These agreements typically require the Company to pay an up-front fee, annual maintenance fees and/or minimum annual royalty fees, legal fees related to the patents, and certain milestone and royalty fees if the patents are eventually used in a commercialized product. In addition, the Company must provide the licensor with periodic reports.

Commercialand intellectual property sub-licensing agreements

The Company has entered into numerous partnering and sub-licensing agreements. With regards to the Company’s developed tests, the Company has entered into a range of marketing and sales arrangements with commercial entities. These important relationships provide the Company with additional resources and infrastructure to expand the geographic reach and awareness of the Company’s solutions, primarily in relation to the Confirm mdx and Select mdx tests. MDxHealth’s marketing partners include, Ferrer Internacional (Spain), Teva Pharmaceuticals (Israel), and SouthGenetics (South and Central America), LifeLabs (Canada) and, in the US, LabCorp, Miraca Life Sciences, Bostwick Laboratories.

In regard to intellectual property that MDxHealth has developed or improved, MDxHealth has sublicensed certain of its non-core technologies to commercial partners, several of whom have launched products that generate royalties and other fees. These sublicenses include an exclusive sublicense to Laboratory Corporation of America (LabCorp) for the MGMT test, which LabCorp began to commercialize in North America in 2008, and an exclusive sublicense to Vesica Health, Inc. for the Company’s patented AssureMDx test for the purpose of bladder cancer detection on a worldwide basis.

F-43

Litigation

As of the date of this document and as far as MDxHealth is aware, the Company is not involved in any material legal proceedings.

NOTE 27: Subsequent events

On February 3, 2023, the Company announced the pricing of a registered public offering of 10,000,000 American Depositary Shares (“ADSs”) (each representing 10 ordinary shares of the Company without nominal value) at a price to the public of $4.00 per ADS (equivalent to a price of €0.364 per share, assuming an exchange rate of €1 = $1.0988 as published by the European Central bank on February 2, 2023 and a 10-for-1 ADS to share ratio) for total gross proceeds of $40.0 million before deducting commissions and estimated offering expenses.

On March 6, 2023, the Company announced that, in the context of the above-mentioned offering, the underwriters exercised the option to purchase additional ADSs, on the same terms and conditions as stated above, in the amount of 750,000 ADSs for gross proceeds of $3.0 million, bringing the aggregate gross proceeds from this transaction to $43.0 million.

On April 19, 2023, the Company announced that it has received notice that its Select mdx for Prostate Cancer test has successfully completed the technical assessment process with the Molecular Diagnostics Services (MolDX) Program developed by Palmetto GBA. Select mdx will be reimbursed throughout the U.S. for Medicare patients who meet coverage conditions under the foundational Local Coverage Determination (LCD) for Molecular Biomarkers to Risk-Stratify Patients at Increased Risk for Prostate Cancer.

NOTE 28: Subsidiaries

The Company has the following two wholly-owned direct subsidiaries:

MDxHealth Inc.
Address	15279 Alton Parkway – Suite 100 – Irvine, CA 92618
Incorporation<br> Date	April 14, 2003
Number<br> of employees	236 at December 31, 2022, 176 at December 31, 2021 and 163 at December 31, 2020.
MDxHealthB.V.
Address	Transistorweg 5, 6534 AT Nijmegen, The Netherlands
Incorporation<br> Date	October 18, 2006
Incorporated<br> into MDxHealth on	September 18, 2015
Number<br> of employees	12 at December 31, 2022, 11 at December 31, 2021 and 9 at December 31, 2020.

F-44

NOTE 29: Principal audit fees and services

During the past fiscal year, in addition to their usual activity, the statutory auditor performed additional activities on behalf of the Company mainly for the issuance of special reports related to warrant plans, grant report certification, for participation to the audit committees and for participation to special projects.

The detail is presented in the table below:

For the years ended	in thousands of					in thousands of
December 31	2022	2021		2020		2022	2021		2020
Audit fee for statutory and consolidated financials			182		85			155		75
Other audit fees			183		-			156		-
Audit related and other services			17		10			14		8
Total			382		95			325		83

All values are in US Dollars.

F-45

Exhibit 2.3

DESCRIPTION OF SECURITIES REGISTERED PURSUANTTO

SECTION 12 OF THE SECURITIES EXCHANGE ACT OF1934

The following description of the ordinary shares,the American Depositary Shares and the articles of association of MDxHealth SA (“MDxHealth”, the “Company” or“we,” “our,” or “us”) is a summary and does not purport to be complete. This summary is subject to,and qualified in its entirety by reference to, the complete text of the Company’s articles of association, which is incorporatedby reference as Exhibit 1.1 of the Company’s Annual Report on Form 20-F, to which this description is also an exhibit.

As of December 31, 2022, MDxHealth had the following series of securities registered pursuant to Section 12(b) of the Securities Exchange Act of 1934, as amended, or the Exchange Act:

Title of Each Class	Trading Symbol	Name of Each Exchange on Which Registered
Ordinary shares, no nominal value per share*	*	The Nasdaq Capital Market
American Depositary Shares, each representing 10 ordinary shares, no nominal value per share	MDXH	The Nasdaq Capital Market

*	Not<br>for trading, but only in connection with the registration of American Depositary Shares.

I. ORDINARY SHARES

DESCRIPTION OF SHARE CAPITAL AND ARTICLES OF ASSOCIATION

Form and Transferability of Our Shares

The shares underlying the ADSs are all ordinary shares, are fully paid, and rank pari passu in all respects with all other existing and outstanding shares of the Company.

All of our shares belong to the same class of securities and are in registered form or in dematerialized form. All of our outstanding shares are fully paid-up and freely transferable, subject to any contractual restrictions.

Belgian company law and our articles of association entitle shareholders to request, in writing and at their expense, the conversion of their dematerialized shares into registered shares and vice versa. Any costs incurred as a result of the conversion of shares into another form will be borne by the shareholder. For shareholders who opt for registered shares, the shares will be recorded in our shareholder register.

Currency

Our share capital, which is represented by our outstanding ordinary shares, is denominated in Euros. The shares underlying the ADSs do not have a nominal value, but each reflect the same fraction of our share capital.

Changes to the share capital decided bythe shareholders

In principle, changes to our share capital are decided by our shareholders. Our general shareholders’ meeting may at any time decide to increase or reduce the share capital of the Company. Such resolution must satisfy the quorum and majority requirements that apply to an amendment of the articles of association, as described below under “— Right to attend and vote at general shareholders’ meetings” and “— Quorumand majorities.”

Capital increases decided by the board of directors

Subject to the quorum and majority requirements described as described below under subsection “— Right to attend and vote at general shareholders’ meetings” and subsection “— Quorum and majorities”, the general shareholders’ meeting may authorize our board of directors, within certain limits, to increase our share capital without any further approval of our shareholders. This is the so-called authorized capital. This authorization needs to be limited in time (i.e. it can only be granted for a renewable period of maximum five years) and scope (i.e. the authorized capital may not exceed the amount of the registered capital at the time of the authorization).

By virtue of the resolution of the extraordinary general shareholders’ meeting of the Company held on May 27, 2021, as published by excerpt in the Annexes to the Belgian Official Gazette (Belgisch Staatsblad/Moniteur belge) on June 1, 2021 under number 21333389, which entered into force on June 1, 2021, the board of directors of the Company has been granted certain powers to increase our share capital in the framework of the authorized capital. The powers under the authorized capital have been set out in article 6 of the Company’s articles of association.

Pursuant to the authorization granted by the extraordinary general shareholders’ meeting, the board of directors is authorized to increase the share capital of the Company on one or several occasions by a maximum aggregate amount of €90,132,067.69 (excluding issue premium, as the case may be).

The board of directors may increase the share capital by contributions in cash or in kind, by capitalization of reserves, whether available or unavailable for distribution, and capitalization of issue premiums, with or without the issuance of new shares, with or without voting rights, that will have the rights as will be determined by the board of directors. The board of directors is also authorized to use this authorization for the issuance of convertible bonds or subscription rights, bonds with subscription rights or other securities.

In the event of a capital increase decided by the board of directors within the framework of the authorized capital, all issue premiums booked, if any, will be accounted for in accordance with the provisions of these articles of association.

The board of directors is authorized, when exercising its powers within the framework of the authorized capital, to restrict or cancel, in the interest of the company, the preferential subscription rights of the shareholders. This restriction or cancellation of the preferential subscription rights can also be done in favor of members of the personnel of the Company or of its subsidiaries, or in favor of one or more persons other than members of the personnel of the Company or of its subsidiaries.

The board of directors is authorized, with the right of substitution, to amend the articles of association, after each capital increase that has occurred within the framework of the authorized capital, in order to bring them in conformity with the new situation of the share capital and the shares.

The board of directors has not yet used its powers under the authorized capital. As a result, the board of directors therefore still has the authority under the authorized capital to increase our share capital with an aggregate amount of €90,132,067.69 (excluding issue premium, as the case may be).

Preferential Subscription Rights

In the event of a capital increase for cash with the issue of new shares, or in the event of an issue of convertible bonds or subscription rights, the existing shareholders have a preferential right to subscribe, pro rata, to the new shares, convertible bonds or subscription rights. These preferential subscription rights are transferable during the subscription period.

Our general shareholders’ meeting may decide to limit or cancel this preferential subscription right, subject to special reporting requirements. Such decision by the general shareholders’ meeting needs to satisfy the same quorum and majority requirements as the decision to increase our share capital.

The shareholders may also decide to authorize our board of directors to limit or cancel the preferential subscription right within the framework of the authorized capital, subject to the terms and conditions set forth in the Belgian Companies and Associations Code. As mentioned above, our board of directors of the Company has been granted certain powers to increase our share capital in the framework of the authorized capital and to cancel the statutory preferential subscription rights of the shareholders (within the meaning of articles 7:191 and 7:193 of the Belgian Companies and Associations Code). The powers under the authorized capital have been set out in article 6 of the Company’s articles of association.

Generally, unless expressly authorized in advance by the general shareholders’ meeting, the authorization of the board of directors to increase our share capital through contributions in cash with cancellation or limitation of the preferential subscription right of the existing shareholders is suspended as of the notification to us by the Belgian Financial Services and Markets Authority, or the FSMA, of a public takeover bid on our financial instruments. Our general shareholders’ meeting did not grant such express authorization to our board of directors. See also “— Capitalincreases decided by the board of directors” above.

Under the DGCL, shareholders of a Delaware corporation have no pre-emptive rights to subscribe for additional issues of stock or to any security convertible into such stock unless, and to the extent that, such rights are expressly provided for in the corporation’s certificate of incorporation.

Acquisition and Sale of own Shares

We may acquire, pledge and dispose of our own shares, profit certificates or associated certificates at the conditions provided for by articles 7:215 and following of the Belgian Companies and Associations Code. These conditions include a prior special shareholders’ resolution approved by at least 75% of the votes validly cast at a general shareholders’ meeting (whereby abstentions are not included in the numerator nor in the denominator) where at least 50% of the share capital and at least 50% of the profit certificates, if any, are present or represented.

Furthermore, shares can only be acquired with funds that would otherwise be available for distribution as a dividend to the shareholders and the transaction must relate to fully paid-up shares or associated certificates. Furthermore, an offer to purchase shares must be made by way of an offer to all shareholders under the same conditions. Shares can also be acquired by us without offer to all shareholders under the same conditions, provided that the acquisition of the shares is effected in the central order book of the regulated market of Euronext Brussels or, if the transaction is not effected via the central order book, provided that the price offered for the shares is lower than or equal to the highest independent bid price in the central order book of the regulated market of Euronext Brussels at that time.

Generally, the general shareholders’ meeting or the articles of association determine the amount of shares, profit certificates or certificates that can be acquired, the duration of such an authorization which cannot exceed five years as from the publication of the proposed resolution as well as the minimum and maximum price that the board of directors can pay for the shares. The prior approval by the shareholders is not required if we purchase the shares to offer them to our personnel, in which case the shares must be transferred within a period of 12 months as from their acquisition.

We may, without prior authorization by the general shareholders’ meeting, dispose of the Company’s own shares, profit certificates or associated certificates in the limited number of situations set out in article 7:218 of the Belgian Companies and Associations Code.

Under the DGCL, a Delaware corporation may purchase or redeem its own shares, unless the capital of the corporation is impaired or the purchase or redemption would cause an impairment of the capital of the corporation.

Description of the Rights and Benefits Attached to Our Shares

Right to attend and vote at general shareholders’meetings

Annual meetings of shareholders

Our annual general shareholders’ meeting is held at the registered office of our Company (in Belgium) or at the place determined in the notice convening the general shareholders’ meeting. The meeting is held every year on the last Thursday of May at 10:00 a.m. (Belgian time). If this day would be a Belgian public holiday, the annual general shareholders’ meeting shall be held on the previous business day. At our annual general shareholders’ meeting, the board of directors submits to the shareholders the audited non-consolidated and consolidated annual financial statements and the reports of the board of directors and of the statutory auditor with respect thereto.

The general shareholders’ meeting then decides on the approval of the statutory annual financial statements, the proposed allocation of the Company’s profit or loss, the release from liability of the directors and the statutory auditor, the approval of the remuneration report included in the annual report of the board of directors (it being understood that the vote on the remuneration report is only an advisory vote and that the Company must explain in the remuneration report of the subsequent financial year how it took into account the advisory vote of the general shareholders’ meeting of the previous financial year), of the remuneration policy (as the case may be), and, when applicable, the (re-)appointment or dismissal of the statutory auditor and/or of all or certain directors. In addition, as relevant, the general shareholders’ meeting must also decide on the approval of the remuneration of the directors and statutory auditor for the exercise of their mandate, and on the approval of provisions of service agreements to be entered into with executive directors, members of the executive management and other executives providing (as the case may be) for severance payments exceeding twelve months’ remuneration (or, subject to a motivated opinion by the remuneration and nomination committee, 18 months’ remuneration) (see also “— Voting rightsattached to the Shares” below).

Special and extraordinary generalshareholders’ meetings

Our board of directors or the statutory auditor (or the liquidators, if appropriate) may, whenever the interest of our Company so requires, convene a special or extraordinary general shareholders’ meeting. Pursuant to article 7:126 of the Belgian Companies and Associations Code, such general shareholders’ meeting must also be convened every time one or more shareholders holding, alone or together, at least 10% of our company’s share capital so request. Shareholders that do not hold at least 10% of our share capital do not have the right to have the general shareholders’ meeting convened.

Under the DGCL, special meetings of the shareholders of a Delaware corporation may be called by such person or persons as may be authorized by the certificate of incorporation or by the bylaws of the corporation, or if not so designated, as determined by the board of directors. Shareholders generally do not have the right to call meetings of shareholders, unless that right is granted in the certificate of incorporation or the bylaws.

Right to put items on the agendaof the general shareholders’ meeting and to table draft resolutions

Shareholders who hold alone or together with other shareholders at least 3% of our share capital have the right to put additional items on the agenda of a general shareholders’ meeting that has been convened and to table draft resolutions in relation to items that have been or are to be included in the agenda. This right does not apply to general shareholders’ meetings that are being convened on the grounds that the quorum was not met at the first duly convened meeting (see “— Quorum and majorities” below). Shareholders wishing to exercise this right must prove on the date of their request that they own at least 3% of the outstanding share capital. The ownership must be based, for dematerialized shares, on a certificate issued by the applicable settlement institution for the shares concerned, or by a certified account holder, confirming the number of shares that have been registered in the name of the relevant shareholders and, for registered shares, on a certificate of registration of the relevant shares in the share register book of the Company. In addition, the shareholder concerned must register for the meeting concerned with at least 3% of the outstanding share capital (see also “— Formalitiesto attend the general shareholders’ meeting” below). A request to put additional items on the agenda and/or to table draft resolutions must be submitted in writing, and must contain, in the event of an additional agenda item, the text of the agenda item concerned and, in the event of a new draft resolution, the text of the draft resolution. The request must reach the Company at the latest on the twenty-second calendar day preceding the date of the general shareholders’ meeting concerned. If the Company receives a request, it will have to publish at the latest on the fifteenth calendar day preceding the general shareholders’ meeting an update of the agenda of the meeting with the additional agenda items and draft resolutions.

Notices convening the general shareholders’ meeting

The notice convening the general shareholders’ meeting must state the place, date and hour of the meeting and must include an agenda indicating the items to be discussed and the proposed resolutions. The notice must, as the case may be, include the proposal of the audit committee to nominate a statutory auditor responsible for auditing the consolidated financial statements. The notice also needs to contain a description of the formalities that security holders must fulfil in order to be admitted to the general shareholders’ meeting and (as the case may be) exercise their voting right, information on the manner in which shareholders can put additional items on the agenda and table draft resolutions, information on the manner in which security holders can ask questions during the general shareholders’ meeting and prior to the meeting via the Company’s email address or a specific email address mentioned in this notice, information on the procedure to participate to the general shareholders’ meeting by means of a proxy or to vote by means of a remote vote, and, as applicable, the registration date for the general shareholders’ meeting. The notice must also mention where shareholders can obtain a copy of the documentation that will be submitted to the general shareholders’ meeting, the agenda with the proposed resolutions or, if no resolutions are proposed, a commentary by the board of directors, updates of the agenda if shareholders have put additional items or draft resolutions on the agenda, the forms to vote by proxy or by means of a remote vote, and the address of the webpage on which the documentation and information relating to the general shareholders’ meeting will be made available. This documentation and information, together with the notice and the total number of outstanding voting rights, must also be made available on our company’s website at the same time as the publication of the notice convening the meeting, for a period of five years after the relevant general shareholders’ meeting.

The notice convening the general shareholders’ meeting has to be published at least 30 calendar days prior to the general shareholders’ meeting in the Belgian Official Gazette (Belgisch Staatsblad/Moniteur Belge), in a newspaper that is published nation-wide in Belgium, in paper or electronically, in media that can be reasonably relied upon for the dissemination of information within the EEA in a manner ensuring fast access to such information on a non-discriminatory basis, and on our company’s website. A publication in a nation-wide newspaper is not needed for annual general shareholders’ meetings taking place on the date, hour and place indicated in the articles of association of the Company if the agenda is limited to the treatment and approval of the financial statements, the annual report of the board of directors, the report of the statutory auditor, the remuneration report, the severance pay for executive directors, and the discharge from liability of the directors and statutory auditor. See also “— Voting Rights attached to the Shares” below. In addition to this publication, the notice has to be distributed at least 30 calendar days prior to the meeting via the normal publication means that the Company uses for the publication of press releases and regulated information. The term of 30 calendar days prior to the general shareholders’ meeting for the publication and distribution of the convening notice can be reduced to 17 calendar days for a second meeting if, as the case may be, the applicable quorum for the meeting is not reached at the first meeting, the date of the second meeting was mentioned in the notice for the first meeting and no new item is put on the agenda of the second meeting. See also further below under “— Quorum and majorities.”

At the same time as its publication, the convening notice must also be sent to the holders of registered shares, holders of registered convertible bonds, holders of registered subscription rights, holders of registered certificates issued with the co-operation of the Company (if any), and, as the case may be, to the directors and statutory auditor of the Company. This communication needs to be made by e-mail unless the addressee has informed the Company that it wishes to receive the relevant documentation by another equivalent means of communication. If the relevant addressee does not have an e-mail address or if it did not inform the Company thereof, the relevant documentation will be sent by ordinary mail.

Under the DGCL, unless otherwise provided in the certificate of incorporation or bylaws, written notice of any meeting of the shareholders of a Delaware corporation must be given to each shareholder entitled to vote at the meeting not less than ten nor more than sixty days before the date of the meeting and shall specify the place, date, hour and, in the case of a special meeting, the purpose of the meeting.

Formalities to attend the general shareholders’meeting

All holders of shares, warrants, profit-sharing certificates, non-voting shares, convertible bonds, subscription rights or other securities issued by our company, as the case may be, and all holders of certificates issued with the co-operation of our company (if any) can attend the general shareholders’ meetings insofar as the law or the articles of association entitles them to do so and, as the case may be, gives them the right to participate in voting.

In order to be able to attend a general shareholders’ meeting, a holder of securities issued by our company must satisfy two criteria: being registered as holder of securities on the registration date for the meeting, and notify our company:

●

Firstly, the right to attend general shareholders’ meetings applies only to persons who are registered as owning securities on the fourteenth calendar day prior to the general shareholders’ meeting at midnight (Belgian time) via registration, in the applicable register book for the securities concerned (for registered securities) or in the accounts of a certified account holder or relevant settlement institution for the securities concerned (for dematerialized securities or securities in book-entry form).

●

Secondly, in order to be admitted to the general shareholders’ meeting, securities holders must notify our Company at the latest on the sixth calendar day prior to the general shareholders’ meeting whether they intend to attend the meeting and indicate the number of shares in respect of which they intend to do so. For the holders of dematerialized securities or securities in book-entry form, the notice should include a certificate confirming the number of securities that have been registered in their name on the record date. The certificate can be obtained by the holder of the dematerialized securities or securities in book-entry form with the certified account holder or the applicable settlement institution for the securities concerned.

The formalities for the registration of securities holders, and the notification of our company must be further described in the notice convening the general shareholders’ meeting.

Electronic participation

Our board of directors has the possibility to organize the general shareholders’ meeting by means of electronic communication which must (i) allow the Company to verify the capacity and identity of the shareholders using it; (ii) at least enable (a) the securities holders to directly, simultaneously and continuously follow the discussions during the meeting and (b) the shareholders to exercise their voting rights on all points on which the general shareholders’ meeting is required to take a decision; and (iii) allow the securities holders to actively participate to the deliberations and to ask questions during the meeting.

Voting by proxy or remote voting

Each shareholder has, subject to compliance with the requirements set forth above under “—Formalities to attend the general shareholders’ meeting”, the right to attend a general shareholders’ meeting and to vote at the general shareholders’ meeting in person or through a proxy holder, who need not be a shareholder. A shareholder may designate, for a given meeting, only one person as proxy holder, except in circumstances where Belgian law allows the designation of multiple proxy holders. The appointment of a proxy holder may take place in paper form or electronically (in which case the form shall be signed by means of an electronic signature in accordance with applicable Belgian law), through a form which shall be made available by our Company. The signed original paper (handwritten) or electronic form must be received by our Company at the latest on the sixth calendar day preceding the meeting. The appointment a proxy holder must be made in accordance with the applicable rules of Belgian law, including in relation to conflicts of interest and the keeping of a register.

The notice convening the meeting may allow shareholders to vote remotely in relation to the general shareholders’ meeting, by sending a paper form or, if specifically allowed in the notice convening the meeting, by sending a form electronically (in which case the form shall be signed by means of an electronic signature in accordance with applicable Belgian law). These forms shall be made available by our company. The original signed paper form must be received by our company at the latest on the sixth calendar day preceding the date of the meeting. Voting through the signed electronic form may occur until the last calendar day before the meeting.

Our company may also organize a remote vote in relation to the general shareholders’ meeting through other electronic communication methods, such as, among others, through one or several websites. Our company shall specify the practical terms of any such remote vote in the convening notice.

When votes are cast electronically, an electronic confirmation of receipt of the votes is sent to the relevant shareholders that cast the vote. After the general shareholders’ meeting, shareholders can obtain, at least upon request (which must be made no later than three months after the vote), the confirmation that their votes have been validly recorded and taken into account by the Company, unless that information is already available to them. If an intermediary receives such confirmation, it must transmit it without delay to the shareholder.

Holders of securities who wish to be represented by proxy or vote remotely must, in any case comply with the formalities to attend the meeting, as explained under “—Formalitiesto attend the general shareholders’ meeting.” Holders of shares without voting rights, profit-sharing certificates without voting rights, convertible bonds, warrants or certificates issued with the cooperation of our company may attend the general shareholders’ meeting but only with an advisory vote.

Voting rights attached to the Shares

Each shareholder of the Company is entitled to one vote per Share. Shareholders may vote by proxy, subject to the rules described below in “—Right to attend andvote at general shareholders’ meetings” and “—Voting by proxy or remote voting.”

Voting rights can be mainly suspended in relation to shares:

●	which are not fully paid up, notwithstanding the request thereto of the board of directors of the Company;
●	to which more than one person is entitled or on which more than one person has rights in rem (zakelijke rechten/droits réels) on, except in the event a single representative is appointed for the exercise of the voting right vis-à-vis the Company;
●	which entitle their holder to voting rights above the threshold of 3%, 5%, 10%, 15%, 20% and any further multiple of 5% of the total number of voting rights attached to the outstanding financial instruments of our company on the date of the relevant general shareholders’ meeting, in the event that the relevant shareholder has not notified us and the FSMA at least 20 calendar days prior to the date of the general shareholders’ meeting in accordance with the applicable rules on disclosure of major shareholdings; and
●	of which the voting right was suspended by a competent court or the FSMA.

Pursuant to the Belgian Companies and Associations Code, the voting rights attached to shares owned by the Company, or a person acting in its own name but on behalf of the Company, or acquired by a subsidiary of the Company, as the case may be, are suspended. Generally, the general shareholders’ meeting has sole authority with respect to:

●	the approval of the annual financial statements of the Company;
●	the distribution of profits (except interim dividends (see “— Dividends” below));
●	the appointment (at the proposal of the board of directors and upon recommendation by the remuneration and nomination committee) and dismissal of directors of the Company;
●	the appointment (at the proposal of the board of directors and upon recommendation by the audit committee) and dismissal of the statutory auditor of the Company;
●	the granting of release from liability to the directors and the statutory auditor of the Company;
●	the determination of the remuneration of the directors and of the statutory auditor for the exercise of their mandate;
●	the advisory vote on the remuneration report included in the annual report of the board of directors, upon every material change to the remuneration policy and in any case at least every four years, and the determination of the following features of the remuneration or compensation of directors, members of the executive management and certain other executives (as the case may be): (i) in relation to the remuneration of executive and non-executive directors, members of the executive management and other executives, an exemption from the rule that share based awards can only vest after a period of at least three years as of the grant of the awards, (ii) in relation to the remuneration of executive directors, members of the executive management and other executives, an exemption from the rule that (unless the variable remuneration is less than a quarter of the annual remuneration) at least one quarter of the variable remuneration must be based on performance criteria that have been determined in advance and that can be measured objectively over a period of at least two years and that at least another quarter of the variable remuneration must be based on performance criteria that have been determined in advance and that can be measured objectively over a period of at least three years, (iii) in relation to the remuneration of non-executive directors, any variable part of the remuneration (provided, however that no variable remuneration can be granted to independent non-executive directors), and (iv) any service agreements to be entered into with executive directors, members of the executive management and other executives providing for severance payments exceeding twelve months’ remuneration (or, subject to a motivated opinion by the remuneration and nomination committee, eighteen (18) months’ remuneration);
●	the filing of a claim for liability against directors;
●	the decisions relating to the dissolution, merger and certain other reorganizations of the Company; and
●	the approval of amendments to the articles of association.

Quorum and majorities

In general, there is no attendance quorum requirement for a general shareholders’ meeting and decisions are generally passed with a simple majority of the votes of the shares present or represented. However, capital increases (other than those decided by the board of directors pursuant to the authorized capital), decisions with respect to the Company’s dissolution, mergers, de-mergers and certain other reorganizations of the Company, amendments to the articles of association (other than an amendment of the corporate purpose), and certain other matters referred to in the Belgian Companies and Associations Code do not only require the presence or representation of at least 50% of the share capital of our Company but also a majority of at least 75% of the votes cast (whereby abstentions are not included in the numerator nor in the denominator). An amendment of our company’s corporate purpose requires the approval of at least 80% of the votes cast at a general shareholders’ meeting (whereby abstentions are not included in the numerator nor in the denominator), which can only validly pass such resolution if at least 50% of the share capital of the Company and at least 50% of the profit certificates, if any, are present or represented. In the event where the required quorum is not present or represented at the first meeting, a second meeting needs to be convened through a new notice. The second general shareholders’ meeting may validly deliberate and decide regardless of the number of shares present or represented. The special majority requirements, however, remain applicable.

Under the DGCL, the certificate of incorporation or bylaws of a Delaware corporation may specify the number of shares required to constitute a quorum but in no event shall a quorum consist of less than one-third of shares entitled to vote at a meeting. In the absence of such specifications, a majority of shares entitled to vote shall constitute a quorum.

Right to ask questions

Within the limits of article 7:139 of the Belgian Companies and Associations Code, security holders have a right to ask questions to the directors in connection with the report of the board of directors or the items on the agenda of such general shareholders’ meeting. However, directors may, in the interest of the Company, refuse to answer questions when the communication of certain information or facts could cause prejudice to the Company or is contrary to the obligations of confidentiality entered into by them or by the Company.

Shareholders can also ask questions to the statutory auditor in connection with its report. Such questions can be submitted in writing prior to the meeting or can be asked at the meeting. Written questions to the statutory auditor must be submitted to the Company at the same time. The statutory auditor may, in the interest of the Company, refuse to answer questions when the communication of certain information or facts could cause any or is contrary to its professional secrecy or to obligations of confidentiality entered into by the Company. The statutory auditor has the right to speak at the general meeting in connection with the performance of its duties.

Written and oral questions will be answered during the meeting concerned in accordance with applicable law. In addition, in order for written questions to be considered, the shareholders who submitted the written questions concerned must comply with the formalities to attend the meeting, as explained under “—Formalitiesto attend the general shareholders’ meeting.”

Dividends

All shares participate equally in the Company’s profits (if any). Pursuant to the Belgian Companies and Associations Code, the shareholders can in principle decide on the distribution of profits with a simple majority vote at the occasion of the annual general shareholders’ meeting, based on the most recent statutory audited financial statements, prepared in accordance with Belgian GAAP and based on a (non-binding) proposal of the Company’s board of directors. The Belgian Companies and Associations Code and the Company’s articles of association also authorize the board of directors to declare interim dividends without shareholder approval. The right to pay such interim dividends is, however, subject to certain legal restrictions.

Our company’s ability to distribute dividends is subject to availability of sufficient distributable profits as defined under Belgian law on the basis of our stand-alone statutory accounts prepared in accordance with Belgian GAAP. In particular, dividends can only be distributed if following the declaration and issuance of the dividends the amount of our net assets on the date of the closing of the last financial year as follows from the statutory non-consolidated financial statements (i.e. summarized, the amount of the assets as shown in the balance sheet, decreased with provisions and liabilities, all in accordance with Belgian accounting rules), decreased with, except in exceptional circumstances, to be disclosed and justified in the notes to the annual accounts, the non-amortized costs of incorporation and extension and non-amortized costs for research and development, does not fall below the amount of the paid-up capital (or, if higher, the issued capital), increased with the amount of non-distributable reserves.

In addition, pursuant to Belgian law and our articles of association, the Company must allocate an amount of 5% of our Belgian GAAP annual net profit (nettowinst/bénéficesnets) to a legal reserve in its stand-alone statutory accounts, until the legal reserve amounts to 10% of our share capital. Our legal reserve currently does not meet this requirement nor will it meet the requirement at the time of the closing of this offering. Accordingly, 5% of its Belgian GAAP annual net profit during future years will need to be allocated to the legal reserve, limiting our ability to pay out dividends to its shareholders.

Under the senior secured loan agreement entered into between with Kreos Capital and the Company on November 1, 2019 and amended on October 19, 2020 and April 19, 2021, no distributions can be declared or made without the consent of the Kreos Capital.

In addition, further financial restrictions and other limitations may be contained in future credit agreements.

The right to payment of dividends expires five years after the board of directors declared the dividend payable.

Under the DGCL, a Delaware corporation may pay dividends out of its surplus (the excess of net assets over capital), or in case there is no surplus, out of its net profits for either or both of the fiscal year in which the dividend is declared and the preceding fiscal year (provided that the amount of the capital of the corporation is not less than the aggregate amount of the capital represented by the issued and outstanding stock of all classes having a preference upon the distribution of assets). Dividends may be paid in the form of shares, property or cash.

Appointment of Directors

Pursuant to the Belgian Companies and Associations Code and the articles of association, the board of directors must consist of at least three directors. Our Company’s Corporate Governance Charter provides that the board of directors should have a composition appropriate to the Company’s purpose, its operations, phase of development, structure of ownership and other specifics. Pursuant to the Belgian Companies and Associations Code and the articles of association of the company, the board of directors should be composed of at least three directors. In accordance with the Belgian Corporate Governance Code, the composition of the board of directors should be determined so as to gather sufficient expertise in the company’s areas of activity as well as sufficient diversity of skills, background, age and gender. Pursuant to the Belgian Corporate Governance Code, a majority of the directors must be non-executive directors, and the board of directors should consist of an appropriate number of independent directors. At least three directors should qualify as independent directors in accordance with the criteria described in the Belgian Corporate Governance Code. At least one third of the members of the board of directors must be of the opposite gender.

Liquidation Rights

Our company can only be voluntarily dissolved by a shareholders’ resolution passed with a majority of at least 75% of the votes cast at a meeting of shareholders where at least 50% of the share capital is present or represented. In the event the required quorum is not present or represented at the first meeting, a second meeting needs to be convened through a new notice. The second meeting of shareholders can validly deliberate and decide regardless of the number of shares present or represented.

Under the DGCL, unless the board of directors approves the proposal to dissolve, dissolution of a Delaware corporation must be approved by shareholders holding 100% of the total voting power of the corporation. Only if the dissolution is initiated by the board of directors may it be approved by a simple majority of the corporation’s outstanding shares. The DGCL allows a Delaware corporation to include in its certificate of incorporation a supermajority voting requirement in connection with dissolutions initiated by the board.

In the event of the dissolution and liquidation of our company, the assets remaining after payment of all debts and liquidation expenses will be distributed to the holders of our shares, each receiving a sum on a pro rata basis.

Pursuant to article 7:228 of the Belgian Companies and Associations Code, if, as a result of losses incurred, the ratio of our company’s net assets (determined in accordance with Belgian legal and accounting rules for non-consolidated financial statements) to share capital is less than 50%, the board of directors must convene an extraordinary general shareholders’ meeting within two months as of the date upon which the board of directors discovered or should have discovered this undercapitalization. At this general shareholders’ meeting the board of directors needs to propose either the dissolution of the Company or the continuation of the Company, in which case the board of directors must propose measures to ensure the Company’s continuity. The board of directors must justify its proposals in a special report to the shareholders. Shareholders representing at least 75% of the votes validly cast at this meeting have the right to dissolve the Company, provided that at least 50% of our share capital is present or represented at the meeting.

If, as a result of losses incurred, the ratio of the Company’s net assets to share capital is less than 25%, the same procedure must be followed, it being understood, however, that in that event shareholders representing 25% of the votes validly cast at the meeting can decide to dissolve the Company.

Pursuant to article 7:229 of the Belgian Companies and Associations Code, if the amount of the Company’s net assets has dropped below €61,500 (the minimum amount of share capital of a corporation with limited liability organised under the laws of Belgium (naamloze vennootschap/société anonyme)), any interested party is entitled to request the competent court to dissolve the Company. The court can order the dissolution of the Company or grant a grace period within which the Company is to remedy the situation.

If the Company is dissolved for any reason, the liquidation must be carried out by one or more liquidators appointed by the general shareholders’ meeting and whose appointment has been ratified by the enterprise court. Any balance remaining after discharging all debts, liabilities and liquidation costs must first be applied to reimburse, in cash or in kind, the paid-up capital of the shares not yet reimbursed. Any remaining balance shall be equally distributed amongst all the shareholders.

When the Company’s net equity is positive, the Company does not fall within the scope of the articles 7:228 and 7:229 of the Belgian Companies and Associations Code.

Belgian Legislation and jurisdiction

Notification of significant shareholdings

Pursuant to the Belgian act of 2 May 2007 on the disclosure of significant shareholdings in issuers whose securities are admitted to trading on a regulated market and containing various provisions, as amended from time to time, or the Belgian Transparency Act, a notification to the Company and to the FSMA is required by all natural persons and legal entities (i.e. legal person, enterprise without legal personality, or trust), in the following circumstances:

●	an acquisition or disposal of voting securities, voting rights or financial instruments that are treated as voting securities;
●	the reaching of a threshold by persons or legal entities acting in concert;
●	the conclusion, modification or termination of an agreement to act in concert;
●	the downward reaching of the lowest threshold;
●	the passive reaching of a threshold;
●	the holding of voting securities in the Company upon first admission thereof to trading on a regulated market;
●	where a previous notification concerning the financial instruments treated as equivalent to voting securities is updated;
●	the acquisition or disposal of the control of an entity that holds voting securities in the Company; and
●	where the Company introduces additional notification thresholds in the articles of association,

in each case where the percentage of voting rights attached to the securities held by such persons reaches, exceeds or falls below the legal threshold, set at 5% of the total voting rights, and 10%, 15%, 20% and so on in increments of 5% or, as the case may be, the additional thresholds provided in the articles of association. The Company has provided for an additional threshold of 3% in its articles of association.

The notification must be made promptly and at the latest within four trading days following the moment on which the person who is subject to the notification obligation received knowledge or could be deemed to have received knowledge of the acquisition or disposal of the voting rights triggering the reaching of the threshold. Where the Company receives a notification of information regarding the reaching of a threshold, it has to publish such information within three trading days following receipt of the notification. Subject to certain exceptions, no shareholder may, pursuant to article 25/1 of the Belgian Transparency Act, cast a greater number of votes at a general shareholders’ meeting of the Company than those attached to the rights and securities that it has notified in accordance with the aforementioned disclosure rules at least 20 calendar days prior to the date of the general shareholders’ meeting.

The forms on which such notifications must be made, as well as further explanations, can be found on the website of the FSMA (www.fsma.be). Violation of the disclosure requirements may result in the suspension of voting rights, a court order to sell the securities to a third party and/or criminal liability. The FSMA may also impose administrative sanctions. The Company is required to publicly disclose any notifications received regarding increases or decreases in a shareholder’s ownership of the Company’s securities, and must mention these notifications in the notes to its financial statements.

The obligation to disclose significant shareholdings as well as certain other provisions of Belgian law (e.g., merger control, authorized capital and the requirement to have certain change of control clauses approved by an extraordinary shareholders’ meeting) that may apply to the Company, may make an unsolicited tender offer, merger, change in management or other change in control, more difficult. Such provisions could discourage potential takeover attempts that third parties may consider and that other shareholders may consider to be in their best interest and could adversely affect the market price of the shares. These provisions may also deprive shareholders of the opportunity to sell their shares at a premium (which is typically offered in the context of a takeover bid).

In accordance with U.S. federal securities laws, holders of our ordinary shares and holders of ADSs will be required to comply with disclosure requirements relating to their ownership of our securities. Any person that, after acquiring beneficial ownership of our ordinary shares or ADSs, is the beneficial owners of more than 5% of our outstanding ordinary shares or ordinary shares underlying ADSs must file with the SEC a Schedule 13D or Schedule 13G, as applicable, disclosing the information required by such schedules, including the number of our ordinary shares or ordinary shares underlying ADSs that such person has acquired (whether alone or jointly with one or more other persons). In addition, if any material change occurs in the facts set forth in the report filed on Schedule 13D (including a more than 1% increase or decrease in the percentage of the total shares beneficially owned), the beneficial owner must promptly file an amendment disclosing such change.

Disclosure of Net Short Positions

Pursuant to the Regulation (EU) No. 236/2012 of the European Parliament and the Council on short selling and certain aspects of credit default swaps, any person that acquires or disposes of a net short position relating to our issued share capital, whether by a transaction in shares or ADSs, or by a transaction creating or relating to any financial instrument where the effect or one of the effects of the transaction is to confer a financial advantage on the person entering into that transaction in the event of a decrease in the price of such shares or ADSs is required to notify the FSMA if, as a result of which acquisition or disposal his net short position reaches, exceeds or falls below 0.2% of our issued share capital and each 0.1% above that. If the net short position reaches 0.5%, and also at every 0.1% above that, the FSMA will disclose the net short position to the public.

Public Takeover Bids

Public takeover bids for the Company’s shares and other securities giving access to voting rights (such as subscription rights or convertible bonds, if any) are subject to supervision by the FSMA. Any public takeover bid must be extended to all of the Company’s voting securities, as well as all other securities giving access to voting rights. Prior to making a bid, a bidder must publish a prospectus which has been approved by the FSMA prior to publication.

Belgium has implemented the Thirteenth Company Law Directive (European Directive 2004/25/EC of 21 April 2004) by the Belgian Act of 1 April 2007 on public takeover bids, as amended, or the Belgian Takeover Act, and the Belgian Royal Decree of 27 April 2007 on public takeover bids, as amended, or the Belgian Takeover Decree. The Belgian Takeover Act provides that a mandatory bid must be launched if a person, as a result of its own acquisition or the acquisition by persons acting in concert with it or by persons acting for their account, directly or indirectly holds more than 30% of the voting securities in a company having its registered office in Belgium and of which at least part of the voting securities are traded on a regulated market or on a multilateral trading facility designated by the Belgian Takeover Decree. The mere fact of exceeding the relevant threshold through the acquisition of shares will give rise to a mandatory bid, irrespective of whether the price paid in the relevant transaction exceeds the current market price. The duty to launch a mandatory bid does not apply in certain cases set out in the Belgian Takeover Decree such as (i) in case of an acquisition if it can be shown that a third party exercises control over the company or that such party holds a larger stake than the person holding 30% of the voting securities or (ii) in case of a capital increase with preferential subscription rights decided by the Company’s general shareholders’ meeting.

There are several provisions of Belgian company law and certain other provisions of Belgian law, such as the obligation to disclose significant shareholdings (see “—Notification of significant shareholdings” above) and merger control, that may apply towards the Company and which may create hurdles to an unsolicited tender offer, merger, change in management or other change in control. These provisions could discourage potential takeover attempts that other shareholders may consider to be in their best interest and could adversely affect the market price of the shares of the Company. These provisions may also have the effect of depriving the shareholders of the opportunity to sell their shares at a premium.

In addition, pursuant to Belgian company law, the board of directors of Belgian companies may in certain circumstances, and subject to prior authorization by the shareholders, deter or frustrate public takeover bids through dilutive issuances of equity securities (pursuant to the “authorized capital”) or through share buy-backs (i.e. purchase of own shares). In principle, the authorization of the board of directors to increase the share capital of the Company through contributions in kind or in cash with cancellation or limitation of the preferential subscription right of the existing shareholders is suspended as of the notification to the Company by the FSMA of a public takeover bid on the securities of the Company. The general shareholders’ meeting can, however, under certain conditions, expressly authorize the board of directors to increase the capital of the Company in such case by issuing shares in an amount of not more than 10% of the existing shares at the time of such a public takeover bid. (see also “— Rights attached to the Shares”, “— Changesto the share capital” and “— Capital increases decided by the board of directors”).

The Company’s articles of association do not provide for any specific protective mechanisms against public takeover bids.

Squeeze-out

Pursuant to article 7:82 of the Belgian Companies and Associations Code or the regulations promulgated thereunder, a person or legal entity, or different persons or legal entities acting alone or in concert, who own, together with the company, at least 95% of the securities with voting rights in a public company are entitled to acquire the totality of the securities with voting rights in that company following a squeeze-out offer. The securities that are not voluntarily tendered in response to such an offer are deemed to be automatically transferred to the bidder at the end of the procedure. At the end of the squeeze-out procedure, the company is no longer deemed a public company, unless convertible bonds issued by the company are still spread among the public. The consideration for the securities must be in cash and must represent the fair value (verified by an independent expert) as to safeguard the interests of the transferring shareholders.

A squeeze-out offer is also possible upon completion of a public takeover bid, provided that the bidder holds at least 95% of the voting capital and 95% of the voting securities of the public company. In such a case, the bidder may require that all remaining shareholders sell their securities to the bidder at the offer price of the takeover bid, provided that, in case of a voluntary takeover offer, the bidder has also acquired 90% of the voting capital to which the offer relates. The shares that are not voluntarily tendered in response to any such offer are deemed to be automatically transferred to the bidder at the end of the procedure.

The DGCL provides for shareholders appraisal rights, or the right to demand payment in cash of the judicially determined fair value of the shareholder’s shares, in connection with certain mergers and consolidations.

Sell-out right

Within three months after the end of an acceptance period related to a public takeover bid, holders of voting securities or of securities giving access to voting rights may require the offeror, acting alone or in concert, who owns at least 95% of the voting capital and 95% of the voting securities in a public company following a takeover bid, to buy their securities from them at the price of the bid, on the condition that, in case of a voluntary takeover offer, the offeror has acquired, through the acceptance of the bid, securities representing at least 90% of the voting capital subject to the takeover bid.

Limitations on the Right to OwnSecurities

Neither Belgian law nor our articles of association impose any general limitation on the right of non-residents or foreign persons to hold our securities or exercise voting rights on our securities other than those limitations that would generally apply to all shareholders.

Exchange Controls and Limitations AffectingShareholders

There are no Belgian exchange control regulations that impose limitations on our ability to make, or the amount of, cash payments to residents of the United States.

Securities Exercisable for Ordinary Shares(EquityIncentives)

See “Management — Compensationof Our Directors and Executives — Warrant Plans” for a description of securities granted by our board of directors to our directors, members of the executive management team, employees and other service providers.

Listing

Our ADSs are listed on the Nasdaq Capital Market under the symbol “MDXH.” Our ordinary shares are listed on Euronext Brussels under the symbol “MDXH.BR.”

Transfer Agent and Registrar

The transfer agent and registrar for the ADSs is The Bank of New York Mellon.

II. AMERICAN DEPOSITARY SHARES

Dividends and Distributions

The Bank of New York Mellon, as depositary, registers and delivers American Depositary Shares, or ADSs. Each ADS represents ten ordinary shares (or a right to receive ten ordinary shares) deposited with ING Belgium SA/NV as custodian for the depositary in Belgium. Each ADS may also represent any other securities, cash or other property that may be held by the depositary. The deposited ordinary shares together with any other securities, cash or other property held by the depositary are referred to as the deposited securities. The depositary’s office at which the ADSs are administered and its principal executive office are located at 240 Greenwich Street, New York, New York 10286.

You may hold ADSs either (A) directly (i) by having an American Depositary Receipt, or an ADR, which is a certificate evidencing a specific number of ADSs, registered in your name, or (ii) by having uncertificated ADSs registered in your name, or (B) indirectly by holding a security entitlement in ADSs through your broker or other financial institution that is a direct or indirect participant in The Depository Trust Company, or DTC. If you hold ADSs directly, you are a registered ADS holder, or an ADS holder. This description assumes you are an ADS holder. If you hold the ADSs indirectly, you must rely on the procedures of your broker or other financial institution to assert the rights of ADS holders described in this section. You should consult with your broker or financial institution to find out what those procedures are.

Registered holders of uncertificated ADSs will receive statements from the depositary confirming their holdings. As an ADS holder, we will not treat you as one of our shareholders and you will not have shareholder rights. Belgian law governs shareholder rights. The depositary will be the holder of the ordinary shares underlying your ADSs. As a registered holder of ADSs, you will have ADS holder rights. A deposit agreement among us, the depositary, ADS holders and all other persons indirectly or beneficially holding ADSs sets out ADS holder rights as well as the rights and obligations of the depositary. New York law governs the deposit agreement and the ADSs.

The following is a summary of the material provisions of the deposit agreement. For more complete information, you should read the entire deposit agreement and the form of ADR.

How will you receive dividends and otherdistributions on the ordinary shares?

The depositary has agreed to pay or distribute to ADS holders the cash dividends or other distributions it or the custodian receives on ordinary shares or other deposited securities, upon payment or deduction of its fees and expenses. You will receive these distributions in proportion to the number of ordinary shares your ADSs represent.

*Cash.*The depositary will convert any cash dividend or other cash distribution we pay on the ordinary shares into U.S. dollars, if it can do so on a reasonable basis and can transfer the U.S. dollars to the United States. If that is not possible or if any government approval is needed and cannot be obtained, the deposit agreement allows the depositary to distribute the foreign currency only to those ADS holders to whom it is possible to do so. It will hold the foreign currency it cannot convert for the account of the ADS holders who have not been paid. It will not invest the foreign currency and it will not be liable for any interest.

Before making a distribution, any withholding taxes, or other governmental charges that must be paid will be deducted. The depositary will distribute only whole U.S. dollars and cents and will round fractional cents to the nearest whole cent. If the exchange rates fluctuate during a time when the depositary cannot convert the foreign currency, you may lose some of the value of the distribution.

*Ordinary Shares.*The depositary may distribute additional ADSs representing any ordinary shares we distribute as a dividend or free distribution.

The depositary will only distribute whole ADSs. It will sell ordinary shares which would require it to deliver a fraction of an ADS (or ADSs representing those ordinary shares) and distribute the net proceeds in the same way as it does with cash. If the depositary does not distribute additional ADSs, the outstanding ADSs will also represent the new ordinary shares. The depositary may sell a portion of the distributed ordinary shares (or ADSs representing those ordinary shares) sufficient to pay its fees and expenses in connection with that distribution.

Rights to purchase additional ordinary shares. If we offer holders of our securities any rights to subscribe for additional ordinary shares or any other rights, the depositary may (i) exercise those rights on behalf of ADS holders, (ii) distribute those rights to ADS holders or (iii) sell those rights and distribute the net proceeds to ADS holders, in each case after deduction or upon payment of its fees and expenses. To the extent the depositary does not do any of those things, it will allow the rights to lapse. In that case, you will receive no value for them. The depositary will exercise or distribute rights only if we ask it to and provide satisfactory assurances to the depositary that it is legal to do so. If the depositary will exercise rights, it will purchase the securities to which the rights relate and distribute those securities or, in the case of ordinary shares, new ADSs representing the new ordinary shares, to subscribing ADS holders, but only if ADS holders have paid the exercise price to the depositary. U.S. securities laws may restrict the ability of the depositary to distribute rights or ADSs or other securities issued on exercise of rights to all or certain ADS holders, and the securities distributed may be subject to restrictions on transfer.

*Other Distributions.*The depositary will send to ADS holders anything else we distribute on deposited securities by any means it thinks is legal, fair and practical. If it cannot make the distribution in that way, the depositary has a choice. It may decide to sell what we distributed and distribute the net proceeds, in the same way as it does with cash. Or, it may decide to hold what we distributed, in which case ADSs will also represent the newly distributed property. However, the depositary is not required to distribute any securities (other than ADSs) to ADS holders unless it receives satisfactory evidence from us that it is legal to make that distribution. The depositary may sell a portion of the distributed securities or property sufficient to pay its fees and expenses in connection with that distribution. U.S. securities laws may restrict the ability of the depositary to distribute securities to all or certain ADS holders, and the securities distributed may be subject to restrictions on transfer.

The depositary is not responsible if it decides that it is unlawful or impractical to make a distribution available to any ADS holders. We have no obligation to register ADSs, ordinary shares, rights or other securities under the Securities Act. We also have no obligation to take any other action to permit the distribution of ADSs, ordinary shares, rights or anything else to ADS holders. This means that you may not receive the distributions we make on our ordinary shares or any value for them if it is illegal or impractical for us to make them available to you.

Deposit, Withdrawal and Cancellation

How are ADSs issued?

The depositary will deliver ADSs if you or your broker deposits ordinary shares or evidence of rights to receive ordinary shares with the custodian.

Upon payment of its fees and expenses and of any taxes or charges, such as stamp taxes or stock transfer taxes or fees, the depositary will register the appropriate number of ADSs in the names you request and will deliver the ADSs to or upon the order of the person or persons that made the deposit.

How can ADS holders withdraw the depositedsecurities?

You may surrender your ADSs to the depositary for the purpose of withdrawal. Upon payment of its fees and expenses and of any taxes or charges, such as stamp taxes or stock transfer taxes or fees, the depositary will deliver the ordinary shares and any other deposited securities underlying the ADSs to the ADS holder or a person the ADS holder designates at the office of the custodian. Or, at your request, risk and expense, the depositary will deliver the deposited securities at its office, if feasible. However, the depositary is not required to accept surrender of ADSs to the extent it would require delivery of a fraction of a deposited ordinary share or other security. The depositary may charge you a fee and its expenses for instructing the custodian regarding delivery of deposited securities.

As long as the ordinary shares underlying the ADSs have not yet been admitted to listing and trading on Euronext Brussels, the relevant ADSs can only be cancelled and withdrawn and exchanged into ordinary shares in registered form that are not yet admitted to listing and trading on Euronext Brussels. We committed to use best efforts to have the ordinary shares underlying the ADSs listed as soon as practicably possible on Euronext Brussels after their issuance.

How do ADS holders interchange between certificatedADSs and uncertificated ADSs?

You may surrender your ADS to the depositary for the purpose of exchanging your ADS for uncertificated ADSs. The depositary will cancel that ADS and will send to the ADS holder a statement confirming that the ADS holder is the registered holder of uncertificated ADSs. Upon receipt by the depositary of a proper instruction from a registered holder of uncertificated ADSs requesting the exchange of uncertificated ADSs for certificated ADSs, the depositary will execute and deliver to the ADS holder an ADR evidencing those ADSs.

Voting Rights

How do you vote?

ADS holders may instruct the depositary how to vote the number of deposited ordinary shares their ADSs represent. If we request the depositary to solicit your voting instructions (and we are not required to do so), the depositary will notify you of a shareholders’ meeting and send or make voting materials available to you. Those materials will describe the matters to be voted on and explain how ADS holders may instruct the depositary how to vote. For instructions to be valid, they must reach the depositary by a date set by the depositary. The depositary will try, as far as practical, subject to the laws of Belgium and the provisions of our articles of association or similar documents, to vote or to have its agents vote the ordinary shares or other deposited securities as instructed by ADS holders. If we do not request the depositary to solicit your voting instructions, you can still send voting instructions, and, in that case, the depositary may try to vote as you instruct, but it is not required to do so.

Except by instructing the depositary as described above, you won’t be able to exercise voting rights unless you surrender your ADSs and withdraw the shares. However, you may not know about the meeting enough in advance to withdraw the shares. In any event, the depositary will not exercise any discretion in voting deposited securities and it will only vote or attempt to vote as instructed.

We cannot assure you that you will receive the voting materials in time to ensure that you can instruct the depositary to vote your ordinary shares.

In addition, the depositary and its agents are not responsible for failing to carry out voting instructions or for the manner of carrying out voting instructions. This means that you may not be able to exercise voting rights and there may be nothing you can do if your ordinary shares are not voted as you requested.

In order to give you a reasonable opportunity to instruct the depositary as to the exercise of voting rights relating to deposited securities, if we request the Depositary to act, we agree to give the depositary notice of any such meeting and details concerning the matters to be voted upon at least 30 days in advance of the meeting date.

Fees and Expenses

Persons depositing or withdrawing ordinary shares orADS holders must pay:	For:
$5.00 (or less) per 100 ADSs (or portion of 100 ADSs)	●	Issuance of ADSs, including issuances resulting from a distribution of ordinary shares or rights or other property
	●	Cancellation of ADSs for the purpose of withdrawal, including if the deposit agreement terminates
$.05 (or less) per ADS	●	Any cash distribution to ADS holders
A fee equivalent to the fee that would be payable if securities distributed to you had been ordinary shares and the ordinary shares had been deposited for issuance of ADSs	●	Distribution of securities distributed to holders of deposited securities (including rights) that are distributed by the depositary to ADS holders
$.05 (or less) per ADS per calendar year	●	Depositary services
Registration or transfer fees	●	Transfer and registration of ordinary shares on our share register to or from the name of the depositary or its agent when you deposit or withdraw ordinary shares
Expenses of the depositary	●	Cable (including SWIFT) and facsimile transmissions (when expressly provided in the deposit agreement)
	●	Converting foreign currency to U.S. dollars
Taxes and other governmental charges the depositary or the custodian has to pay on any ADSs or ordinary shares underlying ADSs, such as stock transfer taxes, stamp duty or withholding taxes	●	As necessary
Any charges incurred by the depositary or its agents for servicing the deposited securities	●	As necessary

Payment of Taxes

You will be responsible for any taxes or other governmental charges payable on your ADSs or on the deposited securities represented by any of your ADSs. The depositary may refuse to register any transfer of your ADSs or allow you to withdraw the deposited securities represented by your ADSs until those taxes or other charges are paid. It may apply payments owed to you or sell deposited securities represented by your ADSs to pay any taxes owed and you will remain liable for any deficiency. If the depositary sells deposited securities, it will, if appropriate, reduce the number of ADSs to reflect the sale and pay to ADS holders any proceeds, or send to ADS holders any property, remaining after it has paid the taxes.

Tender and Exchange Offers; Redemption, Replacementor Cancellation of Deposited Securities

The depositary will not tender deposited securities in any voluntary tender or exchange offer unless instructed to do so by an ADS holder surrendering ADSs and subject to any conditions or procedures the depositary may establish.

If deposited securities are redeemed for cash in a transaction that is mandatory for the depositary as a holder of deposited securities, the depositary will call for surrender of a corresponding number of ADSs and distribute the net redemption money to the holders of called ADSs upon surrender of those ADSs.

If there is any change in the deposited securities such as a sub-division, combination or other reclassification, or any merger, consolidation, recapitalization or reorganization affecting the issuer of deposited securities in which the depositary receives new securities in exchange for or in lieu of the old deposited securities, the depositary will hold those replacement securities as deposited securities under the deposit agreement.

However, if the depositary decides it would not be lawful and practical to hold the replacement securities because those securities could not be distributed to ADS holders or for any other reason, the depositary may instead sell the replacement securities and distribute the net proceeds upon surrender of the ADSs.

If there is a replacement of the deposited securities and the depositary will continue to hold the replacement securities, the depositary may distribute new ADSs representing the new deposited securities or ask you to surrender your outstanding ADSs in exchange for new ADSs identifying the new deposited securities.

If there are no deposited securities underlying ADSs, including if the deposited securities are cancelled, or if the deposited securities underlying ADSs have become apparently worthless, the depositary may call for surrender of those ADSs or cancel those ADSs upon notice to the ADS holders.

Amendment and Termination

How may the deposit agreement be amended?

We may agree with the depositary to amend the deposit agreement and the ADRs without your consent for any reason. If an amendment adds or increases fees or charges, except for taxes and other governmental charges or expenses of the depositary for registration fees, facsimile costs, delivery charges or similar items, or prejudices a substantial right of ADS holders, it will not become effective for outstanding ADSs until 30 days after the depositary notifies ADS holders of the amendment. At the time an amendment becomes effective, you are considered, by continuing to hold your ADSs, to agree to the amendment and to be bound by the ADRs and the deposit agreement as amended.

How may the deposit agreement be terminated?

The depositary will initiate termination of the deposit agreement if we instruct it to do so. The depositary may initiate termination of the deposit agreement if

●	60 days have passed since the depositary told us it wants to resign but a successor depositary has not been appointed and accepted its appointment;
●	we delist the ADSs from an exchange in the United States on which they were listed and do not list the ADSs on another exchange in the United States or make arrangements for trading of ADSs on the U.S. over-the-counter market;
●	we delist our ordinary shares from an exchange outside the United States on which they were listed and do not list the ordinary shares on another exchange outside the United States;
●	the depositary has reason to believe the ADSs have become, or will become, ineligible for registration on Form F-6 under the Securities Act of 1933;
●	we appear to be insolvent or enter insolvency proceedings;
●	all or substantially all the value of the deposited securities has been distributed either in cash or in the form of securities;
●	there are no deposited securities underlying the ADSs or the underlying deposited securities have become apparently worthless; or
●	there has been a replacement of deposited securities.

If the deposit agreement will terminate, the depositary will notify ADS holders at least 90 days before the termination date. At any time after the termination date, the depositary may sell the deposited securities. After that, the depositary will hold the money it received on the sale, as well as any other cash it is holding under the deposit agreement, unsegregated and without liability for interest, for the pro rata benefit of the ADS holders that have not surrendered their ADSs. Normally, the depositary will sell as soon as practicable after the termination date.

After the termination date and before the depositary sells, ADS holders can still surrender their ADSs and receive delivery of deposited securities, except that the depositary may refuse to accept a surrender for the purpose of withdrawing deposited securities or reverse previously accepted surrenders of that kind that have not settled if it would interfere with the selling process. The depositary may refuse to accept a surrender for the purpose of withdrawing sale proceeds until all the deposited securities have been sold. The depositary will continue to collect distributions on deposited securities, but, after the termination date, the depositary is not required to register any transfer of ADSs or distribute any dividends or other distributions on deposited securities to the ADSs holder (until they surrender their ADSs) or give any notices or perform any other duties under the deposit agreement except as described in this paragraph.

Limitations on Obligations and Liability

Limits on our Obligations and the Obligationsof the Depositary; Limits on Liability to Holders of ADSs

The deposit agreement expressly limits our obligations and the obligations of the depositary. It also limits our liability and the liability of the depositary. We and the depositary:

●	are only obligated to take the actions specifically set forth in the deposit agreement without negligence or bad faith, and the depositary will not be a fiduciary or have any fiduciary duty to holders of ADSs;
●	are not liable if we are or it is prevented or delayed by law or by events or circumstances beyond our or its ability to prevent or counteract with reasonable care or effort from performing our or its obligations under the deposit agreement;
●	are not liable if we exercise or it exercises discretion permitted under the deposit agreement;
●	are not liable for the inability of any holder of ADSs to benefit from any distribution on deposited securities that is not made available to holders of ADSs under the terms of the deposit agreement, or for any special, consequential or punitive damages for any breach of the terms of the deposit agreement;
●	have no obligation to become involved in a lawsuit or other proceeding related to the ADSs or the deposit agreement on your behalf or on behalf of any other person;
●	may rely upon any documents we believe or it believes in good faith to be genuine and to have been signed or presented by the proper person;
●	are not liable for the acts or omissions of any securities depository, clearing agency or settlement system; and
●	the depositary has no duty to make any determination or provide any information as to our tax status, or any liability for any tax consequences that may be incurred by ADS holders as a result of owning or holding ADSs or be liable for the inability or failure of an ADS holder to obtain the benefit of a foreign tax credit, reduced rate of withholding or refund of amounts withheld in respect of tax or any other tax benefit.

In the deposit agreement, we and the depositary agree to indemnify each other under certain circumstances.

Requirements for Depositary Actions

Before the depositary will deliver or register a transfer of ADSs, make a distribution on ADSs, or permit withdrawal of ordinary shares, the depositary may require:

●	payment of stock transfer or other taxes or other governmental charges and transfer or registration fees charged by third parties for the transfer of any ordinary shares or other deposited securities;
●	satisfactory proof of the identity and genuineness of any signature or other information it deems necessary; and
---	---
●	compliance with regulations it may establish, from time to time, consistent with the deposit agreement, including presentation of transfer documents.
---	---

The depositary may refuse to deliver ADSs or register transfers of ADSs when the transfer books of the depositary or our transfer books are closed or at any time if the depositary or we think it advisable to do so.

Right to Receive the Ordinary Shares Underlyingyour ADSs

ADS holders have the right to cancel their ADSs and withdraw the underlying ordinary shares at any time except:

●	when temporary delays arise because: (i) the depositary has closed its transfer books or we have closed our transfer books; (ii) the transfer of ordinary shares is blocked to permit voting at a shareholders’ meeting; or (iii) we are paying a dividend on our ordinary shares;
●	when you owe money to pay fees, taxes and similar charges; or
---	---
●	when it is necessary to prohibit withdrawals in order to comply with any laws or governmental regulations that apply to ADSs or to the withdrawal of ordinary shares or other deposited securities.
---	---

This right of withdrawal may not be limited by any other provision of the deposit agreement.

Direct Registration System

In the deposit agreement, all parties to the deposit agreement acknowledge that the Direct Registration System, also referred to as DRS, and Profile Modification System, also referred to as Profile, applies to the ADSs. DRS is a system administered by DTC that facilitates interchange between registered holding of uncertificated ADSs and holding of security entitlements in ADSs through DTC and a DTC participant. Profile is a feature of DRS that allows a DTC participant, claiming to act on behalf of a registered holder of uncertificated ADSs, to direct the depositary to register a transfer of those ADSs to DTC or its nominee and to deliver those ADSs to the DTC account of that DTC participant without receipt by the depositary of prior authorization from the ADS holder to register that transfer.

In connection with and in accordance with the arrangements and procedures relating to DRS/Profile, the parties to the deposit agreement understand that the depositary will not determine whether the DTC participant that is claiming to be acting on behalf of an ADS holder in requesting registration of transfer and delivery as described in the paragraph above has the actual authority to act on behalf of the ADS holder (notwithstanding any requirements under the Uniform Commercial Code). In the deposit agreement, the parties agree that the depositary’s reliance on and compliance with instructions received by the depositary through the DRS/Profile system and in accordance with the deposit agreement will not constitute negligence or bad faith on the part of the depositary.

Shareholder Communications; Inspection of Registerof Holders of ADSs

The depositary will make available for your inspection at its office all communications that it receives from us as a holder of deposited securities that we make generally available to holders of deposited securities. The depositary will send you copies of those communications or otherwise make those communications available to you if we ask it to. You have a right to inspect the register of holders of ADSs, but not for the purpose of contacting those holders about a matter unrelated to our business or the ADSs.

Jury Trial Waiver

The deposit agreement provides that, to the extent permitted by law, ADS holders waive the right to a jury trial of any claim they may have against us or the depositary arising out of or relating to our ordinary shares, the ADSs or the deposit agreement, including any claim under the U.S. federal securities laws. If we or the depositary opposed a jury trial demand based on the waiver, the court would determine whether the waiver was enforceable in the facts and circumstances of that case in accordance with applicable case law.

You will not, by agreeing to the terms of the deposit agreement, be deemed to have waived our or the depositary’s compliance with U.S. federal securities laws and the rules or regulations promulgated thereunder.

Exhibit 4.15

CERTAIN INFORMATION (INDICATED BY ASTERISKS) HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED.

LOAN AND SECURITY AGREEMENT

THIS LOAN AND SECURITY AGREEMENT (as the same may be amended, restated, modified, or supplemented from time to time, this “Agreement”) dated as of August 2, 2022 (the “Effective Date”) among INNOVATUS LIFE SCIENCES LENDING FUND I, LP, a Delaware limited partnership, as collateral agent (in such capacity, together with its successors and assigns in such capacity, “Collateral Agent”), and the Lenders listed on Schedule 1.1 hereof or otherwise a party hereto from time to time including INNOVATUS LIFE SCIENCES LENDING FUND I, LP in its capacity as a Lender, and MDXHEALTH SA, a limited liability company existing under the laws of Belgium, having its registered office at Rue d’Abhooz 31, 4040 Herstal, Belgium and registered under company number 0470.292.440 RLP Liège, division Liège (“Parent”) and MDXHEALTH, INC., a Delaware corporation with offices located at 15279 Alton Parkway, Suite 100, Irvine, CA 92618 (“US Sub”; together with Parent, individually and collectively, jointly and severally, “Borrower”), provides the terms on which the Lenders shall lend to Borrower and Borrower shall repay the Lenders. The parties agree as follows:

1.	DEFINITIONS, ACCOUNTING AND OTHER TERMS

1.1 Capitalized terms used herein shall have the meanings set forth in Section 13 to the extent defined therein. All other capitalized terms used but not defined herein shall have the meaning given to such terms in the Code. Any accounting term used but not defined herein shall be construed in accordance with IFRS and all calculations shall be made in accordance with IFRS. The term “financial statements” shall include the accompanying notes and schedules. Any section, subsection, schedule or exhibit references are to this Agreement unless otherwise specified.

2.	LOANS AND TERMS OF PAYMENT

2.1 Promiseto Pay. Borrower hereby unconditionally promises to pay each Lender the outstanding principal amount of the Term Loan advanced to Borrower by such Lender and accrued and unpaid interest thereon and any other amounts due hereunder as and when due in accordance with this Agreement.

2.2 TermLoans.

(a)

(i) Subject to the terms and conditions of this Agreement, the Lenders agree, severally and not jointly, to make a term loan to Borrower on the Effective Date in an aggregate principal amount of Thirty Five Million Dollars ($35,000,000.00) according to each Lender’s Term Loan Commitment as set forth on Schedule 1.1 hereto (the “Term A Loan”). After repayment, the Term A Loan may not be re-borrowed.

(ii) Subject to the terms and conditions of this Agreement, the Lenders agree, severally and not jointly, to make a term loan to Borrower during the Term B Draw Period in an aggregate principal amount of Twenty Million Dollars ($20,000,000.00), in a single tranche of Twenty Million Dollars ($20,000,000) or two tranches of Ten Million Dollars ($10,000,000) each, according to each Lender’s Term Loan Commitment as set forth on Schedule 1.1 hereto (such term loans are hereinafter referred to singly and collectively, jointly and severally as “TermB Loan”). After repayment, the Term B Loan may not be re-borrowed.

(iii) Subject to the terms and conditions of this Agreement, the Lenders agree, severally and not jointly, to make a term loan to Borrower during the Term C Draw Period in an aggregate principal amount of Fifteen Million Dollars ($15,000,000.00), in a single tranche of Fifteen Million Dollars ($15,000,000) or two tranches of Seven Million Five Hundred Thousand Dollars ($7,500,000) each, according to each Lender’s Term Loan Commitment as set forth on Schedule 1.1 hereto (such term loans are hereinafter referred to singly and collectively, jointly and severally as “Term C Loan;” each Term A Loan, Term B Loan and Term C Loan is referred to singly as a “TermLoan” and the Term A Loan, Term B Loan and Term C Loan are referred to collectively as the “Term Loans”). After repayment, the Term C Loan may not be re-borrowed.

(b) Repayment. Borrower shall make monthly payments of interest only commencing on the first (1st) Payment Date following the Funding Date of any Term Loan, and continuing on the Payment Date of each successive month thereafter through and including the Payment Date immediately preceding the Amortization Date. Borrower agrees to pay, on the Funding Date of each Term Loan, any initial partial monthly interest payment otherwise due for the period between the Funding Date of such Term Loan and the first Payment Date after such Funding Date. Commencing on the Amortization Date, and continuing on the Payment Date of each month thereafter, Borrower shall make equal monthly payments of principal, together with applicable interest, in arrears, to each Lender, as calculated by Collateral Agent (which calculations shall be deemed correct absent manifest error) based upon: (1) the amount of such Lender’s Term Loan, (2) the effective rate of interest, as determined in Section 2.3(a), and (3) a repayment schedule equal to twelve (12) months. All unpaid principal and accrued and unpaid interest with respect to the Term Loan is due and payable in full on the Maturity Date. The Term Loan may only be prepaid in accordance with Sections 2.2(c) and 2.2(d).

(c) Mandatory Prepayments. If an event described in Section 7.2(c)(ii) occurs, Parent’s American Depositary Shares (“ADSs”) are delisted from The Nasdaq Capital Market for any reason whatsoever, or the Term Loan is accelerated following the occurrence of an Event of Default in accordance with Section 9.1, Borrower shall immediately pay to Lenders, payable to each Lender in accordance with its respective Pro Rata Share, an amount equal to the sum of: (i) all outstanding principal of the Term Loan plus accrued and unpaid interest thereon through the prepayment date, (ii) the Final Fee, (iii) the Prepayment Fee, plus (iv) all other Obligations that are due and payable, including, without limitation, Lenders’ Expenses and interest at the Default Rate with respect to any past due amounts. Notwithstanding (but without duplication with) the foregoing, on the Maturity Date, if the Final Fee had not previously been paid in full in connection with the prepayment of the Term Loan in full, Borrower shall pay to each Lender in accordance with its respective Pro Rata Share, the Final Fee in respect of the Term Loan.

(d) Permitted Prepayment of Term Loan. After the date that is the first anniversary of the Effective Date, Borrower shall have the option to prepay any portion of, of the Term Loan advanced by the Lenders under this Agreement for so long as such prepayment is in the minimum amount of Five Million Dollars ($5,000,000.00) and in increments of Two Million Five Hundred Thousand Dollars ($2,500,000.00), provided Borrower (i) provides written notice to Collateral Agent of its election to prepay the Term Loan at least seven (7) Business Days prior to such prepayment, and (ii) pays to Collateral Agent for the benefit of each Lenders on the date of such prepayment, payable to each Lender in accordance with its respective Pro Rata Share, an amount equal to the sum of (A) the relevant outstanding principal of the Term Loan being prepaid plus accrued and unpaid interest thereon through the prepayment date, (B) the Final Fee with respect to the outstanding principal amount being prepaid, (C) the Prepayment Fee with respect to the outstanding principal amount being prepaid, plus (D) all other outstanding Obligations that are due and payable, including, without limitation, Lenders’ Expenses and interest at the Default Rate with respect to any past due amounts.

2.3 Paymentof Interest on the Term Loan.

(a) Interest Rate. Subject to Section 2.3(b), the principal amount outstanding under the Term Loan shall accrue interest at a floating per annum rate equal to the Basic Rate, determined by Collateral Agent on the Funding Date of the Term Loan and monthly thereafter, which interest shall be payable monthly in arrears in accordance with Sections 2.2(b) and 2.3(e); provided that at the election of Borrower (which, if elected, shall be considered elected on the Funding Date of the applicable Term Loan) with no less than five (5) Business Days’ written notice to Collateral Agent prior to the Funding Date of the applicable Term Loan, a portion of the interest may be payable in-kind by adding an amount equal to the PIK Rate of the outstanding principal amount to the then outstanding principal balance on a monthly basis until the third anniversary of the Effective Date so as to increase the outstanding principal balance of the outstanding Term Loans on each Payment Date and which amount shall be payable when the principal amount of the applicable Term Loans is payable in accordance with Sections 2.2(b) and 2.3(e) and on which principal amount interest shall be owed pursuant to Section 2.3(a).

Interest shall accrue on each Term Loan commencing on, and including, the Funding Date of such Term Loan, and shall accrue on the principal amount outstanding under such Term Loan through and including the day on which such Term Loan is paid in full.

(a) Default Rate. Immediately upon the occurrence and during the continuance of an Event of Default, Obligations shall accrue interest at a floating per annum rate equal to the rate that is otherwise applicable thereto plus five percentage points (5.00%) (the “Default Rate”). Payment or acceptance of the increased interest rate provided in this Section 2.3(b) is not a permitted alternative to timely payment and shall not constitute a waiver of any Event of Default or otherwise prejudice or limit any rights or remedies of Collateral Agent.

(b) 365 Day Year. Interest shall be computed on the basis of a three hundred sixty-five (365) day year and the actual number of days elapsed.

(d) Payments. Except as otherwise expressly provided herein, all payments by Borrower under the Loan Documents shall be made to the respective Lender to which such payments are owed, at such Lender’s office in immediately available funds on the date specified herein. Unless otherwise provided, interest is payable monthly on the Payment Date of each month. Payments of principal and/or interest received after 12:00 noon Eastern time are considered received at the opening of business on the next Business Day. When a payment is due on a day that is not a Business Day, the payment is due the next Business Day and additional fees or interest, as applicable, shall continue to accrue until paid. All payments to be made by Borrower hereunder or under any other Loan Document, including payments of principal and interest, and all fees, expenses, indemnities and reimbursements, shall be made without set off, recoupment or counterclaim, in lawful money of the United States and in immediately available funds.

(e) Changes in Prime Rate. In the event the Prime Rate is changed from time to time hereafter and because of any such change the Basic Rate changes, the Basic Rate shall be increased or decreased, effective as of the day of such change in the Prime Rate.

2.4 Fees. Borrower shall pay to Collateral Agent:

(a) Facility Fee. The Term Loan Facility Fee, which shall be due on the Funding Date of each Term Loan with respect to such Term Loan, to be shared among the Lenders in accordance with their respective Pro Rata Shares;

(b) Final Fee. The Final Fee, when due hereunder, to be shared among the Lenders in accordance with their respective Pro Rata Shares;

(c) Prepayment Fee. The Prepayment Fee, when due hereunder, to be shared among the Lenders in accordance with their respective Pro Rata Shares;

(d) Term B Loan Non-Utilization Fee. If the Term B Draw Period commences and Borrower both (i) fails to draw any of the Term B Loan and (ii) fails to notify Collateral Agent, at any time before the commencement of the Term B Draw Period or at any time before the date that is two (2) weeks after the commencement of the Term B Draw Period, of Borrower’s intent not to draw any portion of the Term B Loan (it being agreed and understood that the Term B Loan can either be drawn in a single tranche of Twenty Million Dollars ($20,000,000) or two tranches of Ten Million Dollars ($10,000,000) each), a non-utilization fee equal to three percent (3.00%) of the undrawn portion of the Term B Loan shall become due and payable on the earliest of (i) the termination of the Term B Draw Period, (ii) the Maturity Date, (iii) acceleration of any Term Loan following an Event of Default, or (iv) the prepayment of the Term Loan pursuant to Section 2.2(c) or (d);

(e) Term C Loan Non-Utilization Fee. If the Term C Draw Period commences and Borrower (i) fails to draw any of the Term C Loan and (ii) fails to notify Collateral Agent, at any time before the commencement of the Term C Draw Period or at any time before the date that is two (2) weeks after the commencement of the Term C Draw Period, of Borrower’s intent not to draw any portion of the Term C Loan (it being agreed and understood that the Term C Loan can either be drawn in a single tranche of Fifteen Million Dollars ($15,000,000) or two tranches of Seven Million Five Hundred Thousand Dollars ($7,500,000) each), a non-utilization fee equal to three percent (3.00%) of the undrawn portion of the Term C Loan shall become due and payable on the earliest of (i) the termination of the Term C Draw Period, (ii) the Maturity Date, (iii) acceleration of any Term Loan following an Event of Default, or (iv) the prepayment of the Term Loan pursuant to Section 2.2(c) or (d); and

(f) Lenders’ Expenses. All Lenders’ Expenses (including reasonable attorneys’ fees and expenses for due diligence, investigation, documentation and negotiation of this Agreement), incurred through and after the Effective Date, when due; provided, however, Borrower shall not be obligated to pay more than One Hundred Sixty Thousand Dollars ($160,000.00) in the aggregate of the Lenders’ Expenses incurred through the Effective Date only.

2.5 Withholding. Payments received by the Collateral Agent or the Lenders from Borrower hereunder will be made free and clear of and without deduction for any and all present or future taxes, levies, imposts, duties, deductions, withholdings, assessments, fees or other charges imposed by any Governmental Authority (including any interest, additions to tax or penalties applicable thereto). Specifically, however, if at any time any Governmental Authority, applicable law, regulation or international agreement requires Borrower to make any withholding or deduction from any such payment or other sum payable hereunder to the Lenders, Borrower hereby covenants and agrees that the amount due from Borrower with respect to such payment or other sum payable hereunder will be increased to the extent necessary to ensure that, after the making of such required withholding or deduction, each Lender receives a net sum equal to the sum which it would have received had no withholding or deduction been required and Borrower shall pay the full amount withheld or deducted to the relevant Governmental Authority within the time allowed and in the minimum amount required by law. Borrower will, promptly furnish the Lenders with proof reasonably satisfactory to the Lenders indicating that Borrower has made such withholding payment. The agreements and obligations of Borrower contained in this Section 2.5 shall survive the termination of this Agreement.

A payment shall not be increased under this Section 2.5 by reason of a withholding or deduction, if:

(a) on the date on which the payment becomes due or payable, the payment could have been made to the Lender without a deduction if the Lender had been a Qualifying Lender, but on that date that Lender is not or has ceased to be a Qualifying Lender other than as a result of any change after the date it became a Lender under this Agreement in (or in the interpretation, administration, or application of) any law or treaty or any published practice or published concession of any relevant taxing authority which is not a BEPS-Related Change; or

(b) the relevant Lender is a Treaty Lender and the Borrower is able to demonstrate that the payment could have been made to the Lender without withholding or deduction had that Lender complied with its obligations indicated in the below paragraph in this Section 2.5.

Each Treaty Lender shall cooperate in completing any procedural formalities necessary for the Borrower to obtain authorization to make payments without or, as the case may be, with a reduced withholding or deduction.

2.6 LenderStatus Confirmation. Each Original Lender, as well as each New Lender in the documentation which it executes on becoming a Party as a Lender, shall indicate which of the following categories it falls in:

(a) not a Qualifying Lender;

(b) a Qualifying Lender (other than a Treaty Lender); or

2.7 IndirectTaxes. All amounts set out or expressed in a Loan Document to be payable by any party to a Lender shall be deemed to be exclusive of any Indirect Taxes. If any Indirect Taxes are or become chargeable on any supply made by any Lender to any party in connection with a Loan Document, that party shall pay to the Lender (in addition to and at the same time as paying the consideration) an amount equal to the amount of the Indirect Taxes. Where a Loan Document requires any party to reimburse or indemnify a Lender for any costs or expenses, that party shall also at the same time pay and indemnify the Lender against all Indirect Taxes incurred by that Lender in respect of the costs or expenses to the extent that the Recipient reasonably determines that it is not entitled to credit or repayment in respect of the Indirect Taxes.

2.8 Non-CooperativeJurisdictions. In respect of the Parent, as at the date of this Agreement, each Original Lender represents that (i) it is not incorporated, established, resident, having its place of effective management, or acting through a permanent establishment situated, as the case may be, in a Non-Cooperative Jurisdiction and (ii) the bank account(s) to which payments will be made to which that Original Lender will be entitled, are not (A) managed by or held with a person or persons incorporated, established, resident or having its place of effective management in a Non-Cooperative Jurisdiction or managed by or held with a permanent establishment situated in a Non-Cooperative Jurisdiction or (B) managed by, or held with, (1) a financial institution incorporated, established, resident or having its place of effective management in a Non-Cooperative Jurisdiction or (2) a branch or office of a financial institution situated in a Non-Cooperative Jurisdiction.

In respect of the Parent, each Lender which is not an Original Lender shall also specify, in the documentation which it executes on becoming a party to this Agreement as a Lender, whether (i) it is incorporated, established, resident, having its place of effective management, or acting through a permanent establishment situated, as the case may be, in a Non-Cooperative Jurisdiction and (ii) the bank account(s) to which payments will be made to which that Lender will be entitled, are (A) managed by or held with a person or persons incorporated, established, resident or having its place of effective management in a Non-Cooperative Jurisdiction or managed by or held with a permanent establishment situated in a Non-Cooperative Jurisdiction or (B) managed by or held with (1) a financial institution incorporated, established, resident or having its place of effective management in a Non-Cooperative Jurisdiction or (2) a branch or office of a financial institution situated in a Non-Cooperative Jurisdiction.

In respect of the Parent, each Lender shall notify the Collateral Agent if it (i) is incorporated, established, resident, having its place of effective management, or acting through a permanent establishment situated, as the case may be, in a Non-Cooperative Jurisdiction; or (ii) uses for the purposes of the Loan Documents a bank account (A) managed by or held with a person or persons incorporated, established, resident or having its place of effective management in a Non-Cooperative Jurisdiction or managed by or held with a permanent establishment situated in a Non-Cooperative Jurisdiction or (B) managed by, or held with, (1) a financial institution incorporated, established, resident or having its place of effective management in a Non-Cooperative Jurisdiction or (2) a branch or office of a financial institution situated in a Non-Cooperative Jurisdiction, in each case at such time or during such period or in connection with such payments, as indicated by the Parent in a request to make such notification. The Lender shall make such notification within ten Business Days of demand of the Collateral Agent, and the Collateral Agent shall notify the Parent thereof within twenty Business Days of request of the Parent (which shall refer to this Section 2.8).

Each Lender which (i) is incorporated, established, resident, having its place of effective management, or acting through a permanent establishment situated, as the case may be, in a Non-Cooperative Jurisdiction; or (ii) uses for the purposes of the Loan Documents a bank account (A) managed by or held with a person or persons incorporated, established, resident or having its place of effective management in a Non-Cooperative Jurisdiction or managed by or held with a permanent establishment situated in a Non-Cooperative Jurisdiction or (B) managed by, or held with, (1) a financial institution incorporated, established, resident or having its place of effective management in a Non- Cooperative Jurisdiction or (2) a branch or office of a financial institution situated in a Non-Cooperative Jurisdiction, shall within ten Business Days following the receipt of a demand of the Parent (which shall refer to this paragraph 2.8) provide such information as is reasonably requested by the Parent, to demonstrate that it cannot be considered as an artificial construction within the meaning of Article 198, §1, 10° of the Belgian Income Tax Code 1992. Such demand can only be made by the Parent if it is accompanied by a written request from the Belgian tax authorities to the Parent to demonstrate that the Lender is not an artificial construction within the meaning of Article 198, §1, 10° of the Belgian Income Tax Code 1992.

The Collateral Agent and each Lender shall, in consultation with the Parent, take all reasonable steps to mitigate any circumstances which arise and which would result in any amount payable under a Loan Document by a Borrower established in Belgium not being deductible from that Borrower’s taxable income for Belgian tax purposes by reason of that amount being (i) paid or accrued to the Collateral Agent or a Lender incorporated, established, resident, having its place of effective management, or acting through a permanent establishment situated, as the case may be, in a Non-Cooperative Jurisdiction or (ii) paid to an account opened in the name of or for the benefit of that Collateral Agent or Lender and (A) managed by or held with a person or persons incorporated, established, resident or having its place of effective management in a Non-Cooperative Jurisdiction or managed by or held with a permanent establishment situated in a Non-Cooperative Jurisdiction or (B) managed by, or held with, (1) a financial institution incorporated, established, resident or having its place of effective management in a Non-Cooperative Jurisdiction or (2) a branch or office of a financial institution situated in a Non-Cooperative Jurisdiction; including (but not limited to) transferring its rights and obligations under the Loan Documents to another Affiliate or permanent establishment.

2.9 SecuredPromissory Notes. Each Term Loan shall be evidenced by a Secured Promissory Note or Notes in the form attached as Exhibit D hereto (each a “Secured Promissory Note”), and shall be repayable as set forth in this Agreement. Borrower irrevocably authorizes each Lender to make or cause to be made, on or about the Funding Date of any Term Loan or at the time of receipt of any payment of principal on such Lender’s Secured Promissory Note, an appropriate notation on such Lender’s Secured Promissory Note Record reflecting the making of such Term Loan or (as the case may be) the receipt of such payment. The outstanding amount of each Term Loan set forth on such Lender’s Secured Promissory Note Record shall be prima facie evidence of the principal amount thereof owing and unpaid to such Lender, but the failure to record, or any error in so recording, any such amount on such Lender’s Secured Promissory Note Record shall not limit or otherwise affect the obligations of Borrower under any Secured Promissory Note or any other Loan Document to make payments of principal of or interest on any Secured Promissory Note when due. Upon receipt of an affidavit of an officer of a Lender to such effect as to the loss, theft, destruction, or mutilation of its Secured Promissory Note, such Lender shall provide a lost note indemnity therefor by such Lender in form and substance reasonably satisfactory to Borrower, and Borrower shall issue, in lieu thereof, a replacement Secured Promissory Note in the same principal amount thereof and of like tenor and conditions as the Secured Promissory Note.

2.10 ConversionTo Equity. Prior to the third anniversary of the Effective Date, Lenders shall have the right at their election, but not the obligation, to convert up to fifteen percent (15.00%) of the outstanding aggregate principal amount of the Term Loans into (at the Lenders’ option) new ordinary shares of Parent, which shall be delivered in the form of ADSs of Parent (on a ratio of 1 ADS per 10 ordinary shares, or the ratio contemporarily in application at the time of conversion) at a price per ADS equal to $11.21 (which price shall be subject to appropriate adjustment for any stock split, stock dividend, combination, or other recapitalization or reclassification effected after the date hereof) based on the exchange rate then in effect. Such ordinary shares of Parent delivered in the form of ADSs of Parent shall be referred to herein as “Parent Equity.”

To exercise their rights under this Section 2.10, by giving a written notice substantially in the form of Schedule 2 hereto (a “Notice of Conversion”), the Lenders shall notify Parent of the amount of the Term Loans that is to be converted into Parent Equity. In the event the Lenders elect to convert a portion of the principal amount of the Term Loans into Parent Equity, then the relevant principal amount of the Term Loans shall not be repaid in cash but shall remain outstanding as a payable (without accruing interest) (the relevant “ADS Payable”) due by Parent as from valid delivery of an executed Notice of Conversion in relation to such principal amount of the Term Loans, and which payable shall need to be contributed in kind by the Lenders to Parent within the context of a capital increase by Parent within the framework of the authorised capital of Parent (the “Contribution of an ADS Payable”) against the issuance by Parent of the relevant number of new ordinary shares of Parent, which shall be delivered in the form of the relevant ADSs of Parent. For the purpose of Contribution of an ADS Payable, the amount of the relevant ADS Payable shall be converted into euro on the basis of the relevant USD/EUR exchange ratio as shall be published by the European Central Bank (“ECB”) on https://www.ecb.europa.eu/stats/policy_and_exchange_rates/euro_reference_exchange_rates/html/index.en.html (or such other relevant website of the ECB) (the “Exchange Rate”) on the Trading Day preceding the date of the relevant notarial deed in which the issuance of the relevant ordinary shares of Parent underlying the ADSs of Parent and the corresponding capital increase are established, and whereby final amount in euro will be rounded down to the nearest two decimals. Provided that a duly executed Notice of Conversion is delivered by the Lenders to Parent, the relevant ADSs of Parent shall be delivered to the Lenders no later than fifteen (15) Trading Days as from the reception of the relevant Notice of Conversion.

Upon issuance of Parent Equity in accordance with the provisions of this Section 2.10, the principal amount of the Term Loans so converted shall be deemed to have been prepaid for the purposes of this Agreement, provided, however, no Prepayment Fee, Final Fee or any other fee, cost or other amount shall be due with respect to such deemed prepayment. Furthermore, contemporaneously with the issuance of Parent Equity, Parent shall deliver to the Lenders applicable forms and extracts evidencing Parent Equity.

3.	CONDITIONS OF LOANS

3.1 ConditionsPrecedent to Initial Term Loan. Each Lender’s obligation to make the Term Loan is subject to the condition precedent that Collateral Agent and each Lender shall consent to or shall have received on the Effective Date, in form and substance satisfactory to Collateral Agent and each Lender, such documents, and completion of such other matters, as Collateral Agent and each Lender may reasonably deem necessary or appropriate, including, without limitation:

(a) original Loan Documents, each duly executed by the Borrowers;

(b) a completed Perfection Certificate for Borrower and each of its Subsidiaries;

(c) the Operating Documents and good standing certificates (or local law equivalents) of Borrower and its Subsidiaries certified by the Secretary of State (or equivalent agency) of Borrower’s and such Subsidiaries’ jurisdiction of organization or formation and each jurisdiction in which Borrower and each Subsidiary is qualified to conduct business, each as of a date no earlier than thirty (30) days prior to the Effective Date;

(d) a copy of resolutions of the governing body for Borrower evidencing approval of the Term Loan and other transactions evidenced by the Loan Documents (subject to Section 6.2);

(e) duly executed original officer’s certificates for Borrower and each Subsidiary that is a party to the Loan Documents certifying as to (i) the incumbency of each Responsible Officer executing each Loan Document and (ii) the documents delivered pursuant to Section 3.1(d) and 3.1(e), in a form acceptable to Collateral Agent and the Lenders;

(f) certified copies, dated as of date no earlier than thirty (30) days prior to the Effective Date, of financing statement searches, as Collateral Agent shall request, accompanied by written evidence (including any UCC termination statements) that the Liens indicated in any such financing statements either constitute Permitted Liens or have been or, in connection with the initial Term Loan, will be terminated or released;

(g) a duly executed legal opinion of New York counsel to Borrower dated as of the Effective Date;

(h) a duly executed legal opinion regarding capacity and authority of the Borrower’s signatories and Borrower from Borrower’s Belgian counsel;

(i) a payoff letter from Kreos Capital VI (UK) Limited in respect of the Existing Indebtedness;

(j) evidence that (i) the Liens securing the Existing Indebtedness will be terminated and (ii) the documents and/or filings evidencing the perfection of such Liens, including without limitation any financing statements and/or control agreements, have or will, concurrently with the initial Credit Extension, be terminated;

(k) fully executed Acquisition Documents, dated as of or prior to the Effective Date, and evidence acceptable to Collateral Agent that the Oncotype DX GPS Acquisition shall be consummated contemporaneously with the funding of the Term A Loan;

(l) payment of the Facility Fee and Lenders’ Expenses then due as specified in Section 2.4 hereof;

(m) a Belgian law intellectual property rights pledge agreement between the Parent and the Collateral Agent, duly executed by the parties thereto;

(n) a Belgian law accounts and receivables pledge agreement between the Parent and the Collateral Agent, duly executed by the parties thereto; and

(o) a Belgian law business assets pledge agreement between the Parent and the Collateral Agent, duly executed by the parties thereto.

3.2 ConditionsPrecedent to all Term Loans. The obligation of each Lender to extend each Term Loan, including the initial Term Loan, is subject to the following conditions precedent:

(a) receipt by Collateral Agent of (i) an executed Loan Payment Request Form in the form of EXHIBIT B-1 attached hereto and (ii) an executed Disbursement Letter in the form of EXHIBIT B-2 attached hereto;

(b) the representations and warranties in Section 5 hereof shall be true, accurate and complete in all material respects on the date of each Loan Payment Request Form and the date of each Disbursement Letter and the Funding Date of each Term Loan; provided, however, that such materiality qualifier shall not be applicable to any representations and warranties that already are qualified or modified by materiality in the text thereof; and provided, further that those representations and warranties expressly referring to a specific date shall be true, accurate and complete in all material respects as of such date, and no Event of Default shall have occurred and be continuing or result from the funding of such Term Loan;

(d) no Event of Default or an event that with the passage of time could result in an Event of Default, shall exist;

(e) to the extent not delivered at the Effective Date, duly executed original Secured Promissory Notes, in number, form and content acceptable to each Lender, and in favor of each Lender according to its Commitment Percentage, with respect to each Credit Extension made by such Lender after the Effective Date;

(f) other than for the Term A Loan, immediately after funding of such Term Loan, the ratio of the aggregate principal amount of all Term Loans funded to the volume weighted average market capitalization of the Parent for the preceding ten (10) Trading Days is [***] or less; and

(g) payment of the fees and Lenders’ Expenses then due as specified in Section 2.5 hereof.

3.3 Post-ClosingConditions.

(a) Within fourteen (14) days after the Funding Date of the Term A Loan, or such later date as the Collateral Agent agrees to in writing in its sole discretion, Borrower shall deliver to the Collateral Agent duly executed original Control Agreements with respect to any Collateral Accounts maintained by Borrower or any of its Subsidiaries in the in form and substance reasonably satisfactory to Collateral Agent.

(b) Within thirty (30) days of the Funding Date of the Term A Loan, Borrower shall deliver to the Collateral Agent evidence satisfactory to Collateral Agent and the Lenders that the insurance policies required by Section 6.5 hereof are in full force and effect, together with appropriate evidence showing loss payable and/or additional insured clauses or endorsements in favor of Collateral Agent, for the ratable benefit of the Lenders.

(c) Within ninety (90) days of the Funding Date of the Term A Loan (or one hundred twenty (120) days, if requested by Borrower with reasonable explanation for why Borrower requires the additional thirty (30) days), Borrower shall deliver to Collateral Agent;

(i) a landlord’s consent executed in favor of Collateral Agent in respect of all of Borrower’s leased locations in the United States; and

(ii) a bailee waiver executed in favor of Collateral Agent in respect of each third party bailee where Borrower maintains Collateral having a book value in excess of Five Hundred Thousand Dollars ($500,000.00) in the United States.

3.4 Covenantto Deliver. Borrower agrees to deliver to Collateral Agent and the Lenders each item required to be delivered to Collateral Agent under this Agreement as a condition precedent, to any Term Loan. Borrower expressly agrees that the Term Loan made prior to the receipt by Collateral Agent or any Lender of any such item shall not constitute a waiver by Collateral Agent or any Lender of Borrower’s obligation to deliver such item, and any such Term Loan in the absence of a required item shall be made in each Lender’s sole discretion.

3.5 Proceduresfor Borrowing. Subject to the prior satisfaction of all other applicable conditions to the making of the Term Loan set forth in this Agreement, to obtain the Term Loan (other than the Term Loan funded on the Effective Date), Borrower shall notify the Lenders (which notice shall be irrevocable) by electronic mail, facsimile, or telephone by 12:00 noon New York City time twelve (12) Business Days prior to the date the Term Loan is to be made. Together with any such electronic, facsimile or telephonic notification, Borrower shall deliver to Collateral Agent by electronic mail or facsimile a completed Disbursement Letter and Loan Payment Request Form executed by a Responsible Officer or his or her designee. The Collateral Agent may rely on any telephone notice given by a person whom Collateral Agent reasonably believes is a Responsible Officer or designee.

4.	CREATION OF SECURITY INTEREST

4.1 Grantof Security Interest. Borrower hereby grants Collateral Agent, for the ratable benefit of the Lenders, to secure the payment and performance in full of all of the Obligations, a continuing security interest in, and pledges to Collateral Agent, for the ratable benefit of the Lenders, the Collateral, wherever located, whether now owned or hereafter acquired or arising, and all proceeds and products thereof. If Borrower shall acquire a commercial tort claim (as defined in the Code) which claims damages in excess of $250,000.00 after the date hereof against any third party, Borrower shall grant to Collateral Agent, for the ratable benefit of the Lenders, a security interest therein and in the proceeds thereof, all upon the terms of this Agreement, with such writing to be in form and substance reasonably satisfactory to Collateral Agent.

If this Agreement is terminated, Collateral Agent’s Lien in the Collateral shall continue until the Obligations (other than inchoate indemnity obligations) are repaid in full in cash. Upon payment in full in cash of the Obligations (other than inchoate indemnity obligations) and at such time as the Lenders’ obligation to extend the Term Loan has terminated, Collateral Agent shall, at the sole cost and expense of Borrower, release its Liens in the Collateral and all rights therein shall revert to Borrower.

4.2 Authorizationto File Financing Statements. Borrower hereby authorizes Collateral Agent to file financing statements or take any other action required to perfect Collateral Agent’s security interests in the Collateral, without notice to Borrower, with all appropriate jurisdictions to perfect or protect Collateral Agent’s interest or rights under the Loan Documents.

4.3 Pledgeof Collateral. Borrower hereby pledges, assigns and grants to Collateral Agent, for the ratable benefit of the Lenders, a security interest in all the Shares, together with all proceeds and substitutions thereof, all cash, stock and other moneys and property paid thereon, all rights to subscribe for securities declared or granted in connection therewith, and all other cash and noncash proceeds of the foregoing, as security for the performance of the Obligations. On the Effective Date, or, to the extent not certificated as of the Effective Date, within ten (10) days of the certification of any Shares, the certificate or certificates for the Shares will be delivered to Collateral Agent, accompanied by an instrument of assignment duly executed in blank by Borrower. To the extent required by the terms and conditions governing the Shares, Borrower shall cause the books of each entity whose Shares are part of the Collateral and any transfer agent to reflect the pledge of the Shares. Upon the occurrence and during the continuance of an Event of Default hereunder, Collateral Agent may effect the transfer of any securities included in the Collateral (including but not limited to the Shares) into the name of Collateral Agent and cause new (as applicable) certificates representing such securities to be issued in the name of Collateral Agent or its transferee. Borrower will execute and deliver such documents, and take or cause to be taken such actions, as Collateral Agent may reasonably request to perfect or continue the perfection of Collateral Agent’s security interest in the Shares. Unless an Event of Default shall have occurred and be continuing, Borrower shall be entitled to exercise any voting rights with respect to the Shares and to give consents, waivers and ratifications in respect thereof, provided that no vote shall be cast or consent, waiver or ratification given or action taken which would be inconsistent with any of the terms of this Agreement or which would constitute or create any violation of any of such terms. All such rights to vote and give consents, waivers and ratifications shall terminate upon the occurrence and continuance of an Event of Default.

5.	REPRESENTATIONS AND WARRANTIES

Borrower represents and warrants to Collateral Agent and the Lenders as follows:

5.1 DueOrganization, Authorization: Power and Authority. Borrower and each of its Subsidiaries is duly existing and in good standing under the laws of their respective jurisdictions of organization or formation and Borrower and each of its Subsidiaries is qualified and licensed to do business and is in good standing in any jurisdiction in which the conduct of its businesses or its ownership of property requires that it be qualified except where the failure to do so could not reasonably be expected to have a Material Adverse Change. In connection with this Agreement, Borrower and each of its Subsidiaries has delivered to Collateral Agent a completed perfection certificate and any updates or supplements thereto on or before the Effective Date (each a “Perfection Certificate” and collectively, the “Perfection Certificates”). Borrower represents and warrants that all the information set forth on the Perfection Certificates pertaining to Borrower and each of its Subsidiaries is accurate and complete in all material respects.

Without prejudice to Section 6.2, the execution, delivery and performance by Borrower and each of its Subsidiaries of the Loan Documents to which it is a party have been duly authorized, and do not (i) conflict with any of Borrower’s or such Subsidiaries’ organizational documents, including its respective Operating Documents, (ii) contravene, conflict with, constitute a default under or violate any material Requirement of Law applicable thereto, (iii) contravene, conflict or violate any applicable order, writ, judgment, injunction, decree, determination or award of any Governmental Authority by which Borrower or such Subsidiary, or any of their property or assets may be bound or affected, (iv) require any action by, filing, registration, or qualification with, or Governmental Approval from, any Governmental Authority (except such Governmental Approvals which have already been obtained and are in full force and effect) or are being obtained pursuant to Section 6.1(b), or (v) constitute an event of default under any material agreement by which Borrower or any of such Subsidiaries, or their respective properties, is bound. Neither Borrower nor any of its Subsidiaries is in default under any agreement to which it is a party or by which it or any of its assets is bound in which such default could reasonably be expected to have a Material Adverse Change.

5.2 Collateral.

(a) Borrower and each its Subsidiaries have good title to, have rights in, and the power to transfer each item of the Collateral upon which it purports to grant a Lien under the Loan Documents, free and clear of any and all Liens except Permitted Liens, and neither Borrower nor any of its Subsidiaries have any Deposit Accounts, Securities Accounts, Commodity Accounts or other investment accounts other than the Collateral Accounts or the other investment accounts, if any, described in the Perfection Certificates delivered to Collateral Agent in connection herewith with respect of which Borrower or such Subsidiary has given Collateral Agent notice and taken such actions as are necessary to give Collateral Agent a perfected security interest therein. The Accounts are bona fide, existing obligations of the Account Debtors.

(b) The security interest granted herein is and shall at all times continue to be a first priority perfected security interest in the Collateral, subject only to Permitted Liens’.

(c) On the Effective Date, and except as disclosed on the Perfection Certificate (i) the Collateral is not in the possession of any third party bailee, and (ii) no such third party bailee possesses components of the Collateral in excess of Two Hundred Fifty Thousand Dollars ($250,000.00).

(d) All Equipment that is used by Borrower or any of its Subsidiaries is in all material respects of good and marketable quality, free from material defects.

(e) Borrower and each of its Subsidiaries is the sole owner of the Intellectual Property each respectively purports to own, free and clear of all Liens other than Permitted Liens. Except as noted on the Perfection Certificates, neither Borrower nor any of its Subsidiaries is a party to, nor is bound by, any material license or other material agreement relating to Borrower’s Intellectual Property.

5.3 Litigation. Except as disclosed on the Perfection Certificate (or publicly disclosed, a copy of which public disclosure or an electronic link to which public disclosure has been provided to Collateral Agent), there are no actions, suits, investigations, or proceedings pending or, to the Knowledge of the Responsible Officers, threatened in writing by or against Borrower or any of its Subsidiaries involving more than Five Hundred Thousand Dollars ($500,000.00) or a claim for infringement of any intellectual property material to Borrower’s or any of its Subsidiaries’ business. Except as disclosed on the Perfection Certificate (or publicly disclosed, a copy of which public disclosure or an electronic link to which public disclosure has been provided to Collateral Agent), there are no actions, suits, investigations or proceedings pending or, to the Knowledge of the Responsible Officers, threatened in writing by or against Borrower or any Subsidiaries involving challenges to the validity of any Intellectual Property.

5.4 NoMaterial Adverse Change; Financial Statements. All consolidated financial statements for Borrower and its Subsidiaries, delivered to Collateral Agent fairly present, in conformity with applicable law and IFRS, in all material respects the consolidated financial condition of Borrower and its Subsidiaries, and the consolidated results of operations of Borrower and its Subsidiaries. Since the date of the most recent financial statements submitted to any Lender, there has not been a Material Adverse Change.

5.5 Solvency. Borrower and its Subsidiaries, when taken as a whole, are Solvent.

5.6 RegulatoryCompliance. Neither Borrower nor any of its Subsidiaries is an “investment company” or a company “controlled” by an “investment company” under the Investment Company Act of 1940, as amended. Neither Borrower nor any of its Subsidiaries is engaged as one of its important activities in extending credit for margin stock (under Regulations X, T and U of the Federal Reserve Board of Governors). Borrower and each of its Subsidiaries has complied in all material respects with the Federal Fair Labor Standards Act. Neither Borrower nor any of its Subsidiaries is a “holding company” or an “affiliate” of a “holding company” or a “subsidiary company” of a “holding company” as each term is defined and used in the Public Utility Holding Company Act of 2005. Neither Borrower nor any of its Subsidiaries has violated any laws, ordinances or rules, the violation of which could reasonably be expected to have a Material Adverse Change. Neither Borrower’s nor any of its Subsidiaries’ properties or assets has been used by Borrower or such Subsidiary or, to Borrower’s Knowledge, by previous Persons, in disposing, producing, storing, treating, or transporting any hazardous substance other than in material compliance with applicable laws. Borrower and each of its Subsidiaries has obtained all material consents, approvals and authorizations of, made all declarations or filings with, and given all notices to, all Governmental Authorities that are necessary to continue their respective businesses as currently conducted.

None of Borrower, any of its Subsidiaries, or any of Borrower’s or its Subsidiaries’ Affiliates or any of their respective agents acting or benefiting in any capacity in connection with the transactions contemplated by this Agreement is (i) in violation of any Anti Terrorism Law, (ii) engaging in or conspiring to engage in any transaction that evades or avoids, or has the purpose of evading or avoiding or attempts to violate, any of the prohibitions set forth in any Anti Terrorism Law, or (iii) is a Blocked Person. None of Borrower, any of its Subsidiaries, or to the Knowledge of Borrower, any of their Affiliates or agents, acting or benefiting in any capacity in connection with the transactions contemplated by this Agreement, (x) conducts any business or engages in making or receiving any contribution of funds, goods or services to or for the benefit of any Blocked Person, or (y) deals in, or otherwise engages in any transaction relating to, any property or interest in property blocked pursuant to Executive Order No. 13224, any similar executive order or other Anti Terrorism Law.

Any provision of this Section 5.6 shall not apply to any person if and to the extent that it is or would be unenforceable by or in respect of that person by reason of a breach of any applicable Blocking Law.

5.7 Investments. Neither Borrower nor any of its Subsidiaries owns any stock, shares, partnership interests or other equity securities except for Permitted Investments.

5.8 TaxReturns and Payments; Pension Contributions. Borrower and each of its Subsidiaries has timely filed all required tax returns and reports, and Borrower and each of its Subsidiaries, has timely paid all foreign, federal, state, and local taxes, assessments, deposits and contributions owed by Borrower and such Subsidiaries in an amount greater than One Hundred Thousand Dollars ($100,000.00), in all jurisdictions in which Borrower or any such Subsidiary is subject to taxes, including the United States, unless such taxes are being contested in accordance with the next sentence. Borrower and each of its Subsidiaries, may defer payment of any contested taxes, provided that Borrower or such Subsidiary in good faith contests its obligation to pay the taxes by appropriate proceedings promptly and diligently instituted and conducted. Neither Borrower nor any of its Subsidiaries is aware of any claims or adjustments proposed for any of Borrower’s or such Subsidiaries’ prior tax years which could result in additional taxes becoming due and payable by Borrower or its Subsidiaries. Borrower and each of its Subsidiaries have paid all amounts necessary to fund all present pension, profit sharing and deferred compensation plans in accordance with their terms, and neither Borrower nor any of its Subsidiaries have, withdrawn from participation in, and have not permitted partial or complete termination of, or permitted the occurrence of any other event with respect to, any such plan which could reasonably be expected to result in any liability of Borrower or its Subsidiaries, including any liability to the Pension Benefit Guaranty Corporation or its successors or any other Governmental Authority.

5.9 Useof Proceeds. Borrower shall use the proceeds of the Term Loan solely as working capital and to fund its general business requirements in accordance with the provisions of this Agreement, and not for personal, family, household or agricultural purposes, and, in the case of the Term A Loan, to fund the Oncotype DX GPS Acquisition and to pay off the Existing Indebtedness.

5.10 FullDisclosure. No written representation, warranty or other statement of Borrower or any of its Subsidiaries in any certificate or written statement given to Collateral Agent or any Lender, as of the date such representation, warranty, or other statement was made, taken together with all such written certificates and written statements given to Collateral Agent or any Lender, contains any untrue statement of a material fact or omits to state a material fact necessary to make the statements contained in the certificates or statements not misleading (it being recognized that projections and forecasts provided by Borrower or any of its Subsidiaries in good faith and based upon reasonable assumptions are not viewed as facts and that actual results during the period or periods covered by such projections and forecasts may differ from the projected or forecasted results).

5.11 OncotypeDX GPS Acquisition. The Oncotype DX GPS Acquisition shall be consummated contemporaneously with the funding of the Term A Loan in accordance with the Acquisition Documents and no Event of Default shall result therefrom. Furthermore, all asset acquired pursuant to the Oncotype DX GPS Acquisition shall be part of Collateral and subject to Collateral Agent’s continuing perfected security interest.

6.	AFFIRMATIVE COVENANTS

Borrower shall, and shall cause each of its Subsidiaries to, do all of the following:

6.1 GovernmentCompliance.

(a) Maintain its and all its Subsidiaries’ legal existence and good standing in their respective jurisdictions of organization and maintain qualification in each jurisdiction in which the failure to so qualify could reasonably be expected to have a Material Adverse Change. Comply with all laws, ordinances and regulations to which Borrower or any of its Subsidiaries is subject, the noncompliance with which could reasonably be expected to have a Material Adverse Change.

(b) Obtain and keep in full force and effect, all of the material Governmental Approvals necessary for the performance by Borrower and its Subsidiaries of their respective businesses and obligations under the Loan Documents and the grant of a security interest to Collateral Agent for the ratable benefit of the Lenders, in all of the Collateral.

6.2 FinancialStatements, Reports, Certificates; Notices.

(a) Deliver to Collateral Agent and each Lender:

(i) as soon as available, but no later than forty-five (45) days after the last day of each quarter, a company prepared consolidated and consolidating balance sheet, income statement and cash flow statement covering the consolidated operations of Borrower and its Subsidiaries for such month certified by a Responsible Officer and in a form reasonably acceptable to Collateral Agent (it being agreed and understood that Borrower may provide separate financial statements required by this clause (i) (but not including expenses) for the first two quarters after the Effective Date for the Oncotype DX GPS business and that for such first two quarters after the Effective Date, they may not be included in Borrower’s consolidated financials);

(ii) as soon as available, but no later than one hundred twenty (120) days after the last day of Borrower’s fiscal year or within five (5) days of filing with the Securities and Exchange Commission, audited consolidated financial statements prepared under IFRS, consistently applied, together with an unqualified opinion (except for a going concern qualification) on such financial statements from an independent certified public accounting firm of a well-established international reputation;

(iii) as soon as available after approval thereof by Borrower’s board of directors, but no later than the earlier of ten (10) days after such approval and forty-five (45) days after the last day of Borrower’s fiscal year, Borrower’s annual (A) financial projections and (B) budget, in each case, for the entire current fiscal year as approved by Borrower’s board of directors; provided that, any revisions to such projections and/or budget approved by Borrower’s board of directors shall be delivered to Collateral Agent and the Lenders no later than seven (7) days after such approval);

(iv) within five (5) days of delivery, copies of all non-ministerial statements, reports and notices made available to Borrower’s board of directors, security holders or holders of Subordinated Debt;

(v) within five (5) days of filing, all reports on Form 10 K (or Form 20 K), 10 Q and 8 K (or Form 6 K) filed with the (or similar reports filed with the Securities and Exchange Commission);

(vi) notice (at the end of the applicable quarter) of any amendments of or other changes to the Operating Documents of Borrower or any of its Subsidiaries, together with any copies reflecting such amendments or changes with respect thereto;

(vii) as soon as available, but no later than thirty (30) days after the last day of each quarter (or month if an Event of Default has occurred and is continuing), copies of the month end account statements for each Collateral Account maintained by Borrower or its Subsidiaries, which statements may be provided to Collateral Agent and each Lender by Borrower or directly from the applicable institution(s);

(viii) prompt delivery of (and in any event within five (5) days after the same are sent or received) copies of all material correspondence, reports, documents and other filings with any Governmental Authority that could reasonably be expected to have a material adverse effect on any of the Governmental Approvals material to Borrower’s business or otherwise could reasonably be expected to have a Material Adverse Change;

(ix) prompt notice of any event that (A) could reasonably be expected to materially and adversely affect the Borrower’s Intellectual Property and (B) could reasonably be expected to result in a Material Adverse Change;

(x) written notice at least (10) days’ prior to Borrower’s creation of a New Subsidiary in accordance with the terms of Section 6.10;

(xi) written notice at least (30) days’ prior to Borrower’s (A) adding any new offices or business locations, including warehouses (unless such new offices or business locations contain less than Five Hundred Thousand Dollars ($500,000.00) in assets or property of Borrower or any of its Subsidiaries), (B) changing its jurisdiction of organization, (C) changing its organizational structure or type, (D) changing its legal name, or (E) changing any organizational number (if any) assigned by its jurisdiction of organization;

(xii) upon Borrower becoming aware of the existence of any Event of Default or event which, with the giving of notice or passage of time, or both, would constitute an Event of Default, prompt (and in any event within three (3) Business Days) written notice of such occurrence, which such notice shall include a reasonably detailed description of such Event of Default or event which, with the giving of notice or passage of time, or both, would constitute an Event of Default;

(xiii) immediate notice if Borrower or such Subsidiary has Knowledge that Borrower, or any Subsidiary or Affiliate of Borrower, is listed on the OFAC Lists or (a) is convicted on, (b) pleads nolo contendere to, (c) is indicted on, or (d) is arraigned and held over on charges involving money laundering or predicate crimes to money laundering;

(xiv) notice of any commercial tort claim of Borrower in excess of Three Hundred Thousand Dollars ($300,000) and of the general details thereof;

(xv) if Borrower or any of its Subsidiaries is not now a Registered Organization but later becomes one, written notice of such occurrence and information regarding such Person’s organizational identification number within seven (7) Business Days of receiving such organizational identification number; and (xvi) other information as reasonably requested by Collateral Agent or any Lender.

Notwithstanding the foregoing, documents required to be delivered pursuant to the terms hereof (to the extent any such documents are included in materials otherwise filed with the Securities and Exchange Commission) may be delivered electronically and if so delivered, shall be deemed to have been delivered on the date on which Borrower posts such documents, or provides a link thereto, on Borrower’s website on the internet at Borrower’s website address.

(b) Concurrently with the delivery of the financial statements specified in Section 6.2(a)(i) above but no later than thirty (30) days after the last day of each quarter, deliver to Collateral Agent and each Lender:

(i) a duly completed Compliance Certificate signed by a Responsible Officer (if such month is the last month of the quarter);

(ii) an updated Perfection Certificate, on a quarterly basis, to reflect any amendments, modifications and updates to certain information in the Perfection Certificate after the Effective Date to the extent such amendments, modifications and updates are permitted by one or more specific provisions in this Agreement; in each case, subject to the review and approval of Collateral Agent and each Lender;

(iii) copies of any material Governmental Approvals obtained by Borrower or any of its Subsidiaries;

(iv) written notice of the commencement of, and any material development in, the proceedings contemplated by Section 5.8 hereof;

(v) written notice of any litigation or governmental proceedings pending or threatened (in writing) against Borrower or any of its Subsidiaries, which could reasonably be expected to result in damages or costs (to be awarded against Borrower or any of its Subsidiaries) to Borrower or any of its Subsidiaries of more than Five Hundred Thousand Dollars ($500,000.00); and (vi) written notice of all returns, recoveries, disputes and claims regarding Inventory or services that involve more than Five Hundred Thousand Dollars ($500,000.00) individually or in the aggregate in any calendar year.

(c) Keep proper, complete and true books of record and account in accordance with applicable law and IFRS in all material respects. Borrower shall, and shall cause each of its Subsidiaries to, allow, at the sole cost of Borrower, Collateral Agent or any Lender, during regular business hours upon reasonable prior notice (provided that no notice shall be required when an Event of Default has occurred and is continuing), to visit and inspect any of its properties, to examine and make abstracts or copies from any of its books and records, and to conduct a collateral audit and analysis of its operations and the Collateral (provided, however, access to highly confidential proprietary information of Borrower or any of its Subsidiaries may not be provided unless such information relates to the occurrence of Event of Default under this Agreement). Such audits shall be conducted no more often than once every year unless (and more frequently if) an Event of Default has occurred and is continuing. Notwithstanding the foregoing, upon request of any Lender, Borrower agrees to permit such Lender to communicate with Borrower’s accounting firm (in the presence of a representative of the Borrower) with respect to the consolidated financial statements delivered pursuant to this Section 6.2.

6.3 Reserved.

6.4 Taxes;Pensions. Timely file and require each of its Subsidiaries to timely file, all required tax returns and reports and timely pay, and require each of its Subsidiaries to timely pay, all foreign, federal, state, and local taxes, assessments, deposits and contributions owed by Borrower or its Subsidiaries, except as otherwise permitted pursuant to the terms of Section 5.8 hereof, and shall deliver to Collateral Agent and each Lender, on demand, appropriate certificates attesting to such payments, and pay all amounts necessary to fund all present pension, profit sharing and deferred compensation plans in accordance with the terms of such plans.

6.5 Insurance. Commencing with the Effective Date, keep Borrower’s and its Subsidiaries’ business and the Collateral insured for risks and in amounts standard for companies in Borrower’s and its Subsidiaries’ industry and location. Insurance policies shall be in a form, with companies, and in amounts that are reasonably satisfactory to Collateral Agent. All property policies shall have a lender’s loss payable endorsement showing Collateral Agent as lender loss payee and waive subrogation against Collateral Agent, and all liability policies (other than third party liability policies) shall show, or have endorsements showing, Collateral Agent, as additional insured. The Collateral Agent shall be named as lender loss payee and/or additional insured with respect to any such insurance providing coverage in respect of any Collateral, and each provider of any such insurance shall agree, by endorsement upon the policy or policies issued by it or by independent instruments furnished to the Collateral Agent, that it will give the Collateral Agent thirty (30) days’ prior written notice before any such policy or policies shall be materially altered or canceled (other than cancellation for non-payment of premiums, for which ten (10) days’ prior written notice shall be required). At Collateral Agent’s request, Borrower shall deliver certified copies of policies and evidence of all premium payments. Proceeds payable under any policy shall, at Collateral Agent’s option, be payable to Collateral Agent, for the ratable benefit of the Lenders, on account of the Obligations. Notwithstanding the foregoing, (a) so long as no Event of Default has occurred and is continuing, Borrower shall have the option of applying the proceeds of any property policy (related to the Collateral) within 90 days of receipt thereof up to Seven Hundred Fifty Thousand Dollars ($750,000.00) with respect to any loss, but not exceeding Seven Hundred Fifty Thousand Dollars ($750,000.00), in the aggregate for all losses under all property policies in any one year, toward the replacement or repair of destroyed or damaged property; provided that any such replaced or repaired property (i) shall be of equal or like value as the replaced or repaired Collateral and (ii) shall be deemed Collateral in which Collateral Agent has been granted a first priority security interest, and (b) after the occurrence and during the continuance of an Event of Default, all proceeds payable under such casualty policy shall, at the option of Collateral Agent, be payable to Collateral Agent, for the ratable benefit of the Lenders, on account of the Obligations. If Borrower or any of its Subsidiaries fails to obtain insurance as required under this Section 6.5 or to pay any amount or furnish any required proof of payment to third persons, Collateral Agent and/or any Lender may make (but has no obligation to do so), at Borrower’s expense, all or part of such payment or obtain such insurance policies required in this Section 6.5, and take any action under the policies Collateral Agent or such Lender deems prudent.

Notwithstanding anything herein to the contrary, Borrower does not need to provide evidence of its compliance with the provisions of this Section 6.5 until thirty (30) days after the Effective Date.

6.6 OperatingAccounts.

(a) Borrower shall provide Collateral Agent ten (10) days’ prior written notice before Borrower or any of its Subsidiaries establishes any Collateral Account. In addition, for each Collateral Account that Borrower at any time maintains in the United States, Borrower shall cause the applicable bank or financial institution at or with which such Collateral Account is maintained to execute and deliver a Control Agreement or other appropriate instrument with respect to such Collateral Account to perfect Collateral Agent’s Lien in such Collateral Account in accordance with the terms hereunder prior to the establishment of such Collateral Account, which Control Agreement may not be terminated without prior written consent of Collateral Agent. The provisions of the previous sentence shall not apply to deposit accounts exclusively used for payroll, payroll taxes and other employee wage and benefit payments to or for the benefit of Borrower’s, or any of its Subsidiaries’, employees and identified to Collateral Agent by Borrower as such in the Perfection Certificate or with respect to each Medicare Account.

(b) Neither Borrower nor any of its Subsidiaries shall maintain any Collateral Accounts except Collateral Accounts maintained in accordance with Section 6.6.

6.7 Protectionof Intellectual Property Rights. Unless to the extent otherwise permitted under of Section 7.1 hereof, Borrower and each of its Subsidiaries shall: (a) protect, defend and maintain the validity and enforceability of its Intellectual Property that is material to its business; (b) promptly advise Collateral Agent in writing of a challenge to the validity, or material infringement by a third party of its Intellectual Property; and (c) not allow any Intellectual Property material to its business to be abandoned, forfeited or dedicated to the public without Collateral Agent’s prior written consent. If Borrower or any of its Subsidiaries (i) obtains any patent, registered trademark or servicemark, registered copyright, registered mask work, or any pending application for any of the foregoing, whether as owner, licensee or otherwise, or (ii) applies for any patent or the registration of any trademark or servicemark, then Borrower or such Subsidiary shall at the end of the then current quarter provide written notice thereof to Collateral Agent and each Lender and shall execute such intellectual property security agreements and other documents and take such other actions as Collateral Agent shall reasonably request in its good faith business judgment to perfect and maintain a first priority perfected security interest in favor of Collateral Agent, for the ratable benefit of the Lenders, in such property. If Borrower or any of its Subsidiaries decides to register any copyrights or mask works in the United States Copyright Office, Borrower or such Subsidiary shall: (x) provide Collateral Agent and each Lender with at least ten (10) days prior written notice of Borrower’s or such Subsidiary’s intent to register such copyrights or mask works together with a copy of the application it intends to file with the United States Copyright Office (excluding exhibits thereto); (y) execute an intellectual property security agreement and such other documents and take such other actions as Collateral Agent may reasonably request in its good faith business judgment to perfect and maintain a first priority perfected security interest in favor of Collateral Agent, for the ratable benefit of the Lenders, in the copyrights or mask works intended to be registered with the United States Copyright Office; and (z) record such intellectual property security agreement with the United States Copyright Office contemporaneously with filing the copyright or mask work application(s) with the United States Copyright Office. Borrower or such Subsidiary shall promptly provide to Collateral Agent and each Lender with evidence of the recording of the intellectual property security agreement necessary for Collateral Agent to perfect and maintain a first priority perfected security interest in such property.

6.8 Litigation Cooperation. Commencing on the Effective Date and continuing through the termination of this Agreement, make available to Collateral Agent and the Lenders, without expense to Collateral Agent or the Lenders, Borrower and each of Borrower’s officers, employees and agents and Borrower’s Books, to the extent that Collateral Agent or any Lender may reasonably deem them necessary to prosecute or defend any third party suit or proceeding instituted by or against Collateral Agent or any Lender with respect to any Collateral or relating to Borrower.

6.9 Landlord Waivers; Bailee Waivers. In the event that Borrower or any of its Subsidiaries, after the Effective Date, intends to add any new offices or business locations, including warehouses, or otherwise store any portion of the Collateral with, or deliver any portion of the Collateral to, a bailee (other than at clinical sites, with shipping companies for transportation of Inventory in the ordinary course of business, with contract manufacturers holding raw material or work-in process inventory, or with others holding sample collection or specimen transportation kits), in each case pursuant to Section 7.2, then Borrower shall notify Collateral Agent contemporaneously and, in the event that the Collateral at any new location that is in the United States is valued in excess of Five Hundred Thousand Dollars ($500,000.00) in the aggregate, at Collateral Agent’s election, the Borrower shall ensure that such bailee or landlord, as applicable, executes and delivers a bailee waiver or landlord waiver, as applicable, in form and substance reasonably satisfactory to Collateral Agent within ninety (90) days of the addition of any new offices or business locations, or any such storage with or delivery to any such bailee, as the case may be.

6.10 Creation/Acquisition of Subsidiaries. In the event any Borrower or any Subsidiary of any Borrower creates or acquires any Subsidiary after the Effective Date, Borrower or such Subsidiary shall promptly notify Collateral Agent of such creation or acquisition, and Borrower or such Subsidiary shall take all actions reasonably requested by Collateral Agent to achieve any of the following with respect to such “New Subsidiary” (defined as a Subsidiary to become either a co-Borrower hereunder, if such New Subsidiary is organized under the laws of the United States, or a secured guarantor with respect to the Obligations; and (ii) to grant and pledge to Collateral Agent a perfected security interest in the Shares of such New Subsidiary.

6.11 FurtherAssurances. Execute any further instruments and take further action as Collateral Agent or any Lender reasonably requests to perfect or continue Collateral Agent’s Lien in the Collateral or to effect the purposes of this Agreement, including without limitation, permit Collateral Agent or any Lender to discuss Borrower’s financial condition with Borrower’s accountants.

6.12 FinancialCovenant. Commencing on June 30, 2023, Borrower shall achieve [***]

6.13 LiquidityCovenant. Borrower shall at all times maintain in one or more Collateral Accounts in the United States subject to Control Agreement(s) in favor of Collateral Agent an aggregate cash balance of (i) not less than [***], if the last opinion issued by Borrower’s independent certificated public account firm had no qualification with respect to going concern and (ii) not less than [***], if the last opinion issued by Borrower’s independent certificated public account firm had a qualification with respect to going concern; provided, however, each of the foregoing is subject to appropriate increase (on a dollar for dollar basis) in the event of Borrower’s undisputed delinquency in payment of its rent or accounts payable to critical vendors. Notwithstanding anything herein to the contrary, at all times when (i) Borrower has not delivered all applicable Control Agreements in favor of Collateral Agent with respect to Borrower’s Collateral Accounts maintained in the United States in accordance with Section 3.3(a) or (ii) while any portion of the Kreos Discretionary Convertible Debt is outstanding or any payment obligation of Borrower with respect to it is outstanding, Borrower shall at all times maintain in one or more Collateral Accounts in the United States subject to Control Agreement(s) in favor of Collateral Agent an aggregate cash balance of not less than [***].

6.14 SubsequentApprovals

(a) As the case may be, obtain in due time (and prior to Borrower becoming obligated to issue Parent Equity in accordance with the terms of Section 2.10) the legally required board approvals for the issuance of the Parent Equity in accordance with Section 2.10.

(b) Provide to the Collateral Agent (i) evidence that the next following general meeting of the shareholders of the Parent convened after the date of this Agreement has approved and ratified each provision of the Loan Documents that falls within the scope of Article 7:151 of the Belgian Code of Companies and Associations and (ii) evidence that the filing of such approval and ratification with the competent clerk of the enterprise court has been completed within ten (10) Business Days of the date of such general meeting.

6.15 MaterialAgreements. Borrower shall notify Collateral Agent within thirty (30) days of termination of any Material Agreement to which Borrower or any of its Subsidiaries is a party.

6.16 Kreos DiscretionaryConvertible Debt. On or before the date that is thirty days immediately after the Funding Date of the Term A Loan, Borrower shall either convert the entire outstanding amount of the Kreos Discretionary Convertible Debt into equity securities of Borrower or repay all obligations of Borrower under the Kreos Discretionary Convertible Debt (provided, however, the aggregate amount of payment made by Borrower to repay the Kreos Discretionary Convertible Debt under this Section 6.16 shall not exceed $500,000).

7.	NEGATIVE COVENANTS

Borrower shall not, and shall not permit any of its Subsidiaries to, do any of the following without the prior written consent of the Required Lenders:

7.1 Dispositions. Convey, sell, lease, transfer, assign, dispose of (collectively, “Transfer”), or permit any of its Subsidiaries to Transfer, all or any part of its business or property (including Intellectual Property), except for Transfers (a) of Inventory in the ordinary course of business; (b) of worn out or obsolete Equipment and products discontinued in the ordinary course of business; (c) Intellectual Property that is no longer materially useful to the business of Borrower or any of its Subsidiaries as then conducted or proposed to be conducted, in an arm’s length transaction; (d) in connection with Permitted Liens, Permitted Investments and Permitted Licenses; (e) not otherwise prohibited hereunder for proceeds not in excess of Two Hundred Fifty Thousand Dollars ($250,000) in the aggregate in any fiscal year; (f) the lapse or abandonment Intellectual Property of Borrower and its Subsidiaries that is no longer materially useful for the business of Borrower or any of its Subsidiaries as then conducted or proposed to be conducted; (g) from Subsidiary to Borrower; or (g) from one Borrower to another Borrower.

7.2 Changesin Business, Management, Ownership, or Business Locations. (a) Engage in or permit any of its Subsidiaries to engage in any business other than the businesses engaged in by Borrower as of the Effective Date or reasonably related thereto; (b) liquidate or dissolve; or (c) (i) any Key Person shall cease to be actively engaged in the management of Borrower unless written notice thereof is provided to Collateral Agent and each Lender within fifteen (15) days of thereof (it being agreed and understood that publicly viewable filing made with the U.S. Securities and Exchange Commission shall constitute such written notice), or (ii) enter into any transaction or series of related transactions in which (A) the stockholders of Borrower who were not stockholders immediately prior to the first such transaction own more than 49% of the voting stock of Borrower immediately after giving effect to such transaction or related series of such transactions or (B) Borrower ceases to own 100% of the ownership interests of a Subsidiary of Borrower. Borrower shall not, without at least thirty (30) days’ prior written notice to Collateral Agent: (A) add any new offices or business locations, including warehouses (unless such new offices or business locations contain less than Five Hundred Thousand Dollars ($500,000.00) in assets or property of Borrower or any of its Subsidiaries); (B) change its jurisdiction of organization, (C) change its organizational structure or type, (D) change its legal name, or (E) change any organizational number (if any) assigned by its jurisdiction of organization.

7.3 Mergersor Acquisitions. Merge or consolidate, or permit any of its Subsidiaries to merge or consolidate, with any other Person, or acquire, or permit any of its Subsidiaries to acquire, all or substantially all of the capital stock, shares or property of another Person other than the Oncotype DX GPS Acquisition. A Subsidiary may merge or consolidate into another Subsidiary (provided such surviving Subsidiary is a “co Borrower” hereunder or has provided a secured Guaranty of Borrower’s Obligations hereunder) or with (or into) Borrower provided Borrower is the surviving legal entity, and as long as no Event of Default is occurring prior thereto or arises as a result therefrom.

7.4 Indebtedness. Commencing with the Funding Date of the Term A Loan, create, incur, assume, or be liable for any Indebtedness, or permit any Subsidiary to do so, other than Permitted Indebtedness.

7.5 Encumbrance. Commencing with the Funding Date of the Term A Loan, create, incur, allow, or suffer any Lien on any of its property, or assign or convey any right to receive income, including the sale of any Accounts, or permit any of its Subsidiaries to do so, except for Permitted Liens, or permit any Collateral not to be subject to the first priority security interest granted herein (except for Permitted Liens), or enter into any agreement, document, instrument or other arrangement (except with or in favor of Collateral Agent, for the ratable benefit of the Lenders) with any Person which directly or indirectly prohibits or has the effect of prohibiting Borrower, or any of its Subsidiaries, from assigning, mortgaging, pledging, granting a security interest in or upon, or encumbering any of Borrower’s or such Subsidiary’s Intellectual Property, except as is otherwise permitted in Section 7.1 hereof and the definition of “Permitted Liens”.

7.6 Maintenanceof Collateral Accounts. Maintain any Collateral Account except pursuant to the terms of Section 6.6 hereof.

7.7 RestrictedPayments. Pay any dividends (other than dividends payable solely in capital stock) or make any distribution or payment in respect of or redeem, retire or purchase any capital stock other than (i) distributions or repurchases pursuant to the terms of employee stock purchase plans, employee restricted stock agreements, stockholder rights plans, director or consultant stock option plans, or similar plans, provided such repurchases do not exceed Three Hundred Thousand Dollars ($300,000.00) in the aggregate per fiscal year, and (ii) the payment of a dividend or other distribution to Borrower from any of its Subsidiaries.

7.8 Investments. Directly or indirectly make any Investment other than Permitted Investments, or permit any of its Subsidiaries to do so.

7.9 Transactionswith Affiliates. Directly or indirectly enter into or permit to exist any material transaction with any Affiliate of Borrower or any of its Subsidiaries, except for (a) transactions that are in the ordinary course of Borrower’s or such Subsidiary’s business, upon fair and reasonable terms that are no less favorable to Borrower or such Subsidiary than would be obtained in an arm’s length transaction with a non-affiliated Person, and (b) Subordinated Debt or equity investments by Borrower’s investors in Borrower or its Subsidiaries.

7.10 SubordinatedDebt. (a) Make or permit any payment on any Subordinated Debt, except under the terms of the subordination, intercreditor, or other similar agreement to which such Subordinated Debt is subject, or (b) amend any provision in any document relating to the Subordinated Debt which would increase the amount thereof or adversely affect the subordination thereof to Obligations owed to the Lenders.

7.11 Compliance. Become an “investment company” or a company controlled by an “investment company”, under the Investment Company Act of 1940, as amended, or undertake as one of its important activities, extending credit to purchase or carry margin stock (as defined in Regulation U of the Board of Governors of the Federal Reserve System), or use the proceeds of any Term Loan for that purpose; fail to meet the minimum funding requirements of ERISA, permit a Reportable Event or Prohibited Transaction, as defined in ERISA, to occur; fail to comply with the Federal Fair Labor Standards Act or violate any other law or regulation, if the failure to comply or violation could reasonably be expected to have a Material Adverse Change, or permit any of its Subsidiaries to do so; withdraw or permit any Subsidiary to withdraw from participation in, permit partial or complete termination of, or permit the occurrence of any other event with respect to, any present pension, profit sharing and deferred compensation plan which could reasonably be expected to result in any liability of Borrower or any of its Subsidiaries, including any liability to the Pension Benefit Guaranty Corporation or its successors or any other Governmental Authority.

7.12 Compliancewith Anti Terrorism Laws. Neither Borrower nor any of its Subsidiaries shall, nor shall Borrower or any of its Subsidiaries permit any Affiliate to, directly or indirectly, knowingly enter into any documents, instruments, agreements or contracts with any Person listed on the OFAC Lists. Neither Borrower nor any of its Subsidiaries shall, nor shall Borrower or any of its Subsidiaries, permit any Affiliate to, directly or indirectly, (i) conduct any business or engage in any transaction or dealing with any Blocked Person, including, without limitation, the making or receiving of any contribution of funds, goods or services to or for the benefit of any Blocked Person, (ii) deal in, or otherwise engage in any transaction relating to, any property or interests in property blocked pursuant to Executive Order No. 13224 or any similar executive order or other Anti Terrorism Law, or (iii) engage in or conspire to engage in any transaction that evades or avoids, or has the purpose of evading or avoiding, or attempts to violate, any of the prohibitions set forth in Executive Order No. 13224 or other Anti Terrorism Law. Any provision of this Section 7.12 shall not apply to any person if and to the extent that it is or would be unenforceable by or in respect of that person by reason of a breach of any applicable Blocking Law.

8.	EVENTS OF DEFAULT

Any one of the following shall constitute an event of default (an “Event of Default”) under this Agreement:

8.1 PaymentDefault. Borrower fails to (a) make any payment of principal or interest on any Term Loan on its due date, or (b) pay any other Obligations within three (3) Business Days after such Obligations are due and payable (which three (3) Business Day grace period shall not apply to payments due on the Maturity Date or the date or acceleration pursuant to Section 9.1 (a) hereof);

8.2 CovenantDefault.

(a) Borrower or any of its Subsidiaries fails or neglects to perform any obligation in Sections 2.10 (Conversion To Equity), 6.2 (Financial Statements, Reports, Certificates), 6.4 (Taxes), 6.5 (Insurance), 6.6 (Operating Accounts), 6.7 (Protection of Intellectual Property Rights), 6.9 (Landlord Waivers; Bailee Waivers), 6.10 (Creation/Acquisition of Subsidiaries), 6.12 (Financial Covenant), 6.13 (Liquidity Covenant), 6.14 (Subsequent Approvals) or 6.16 (Kreos Discretionary Convertible Debt) or Borrower violates any provision in Section 7; provided, however, in the event that the Borrower fails to comply with the requirements of the financial covenant set forth in Section 6.12, Borrower may cure such breach by means of submitting a new financial plan approved by the board of directors of the Borrower to Collateral Agent which plan must be acceptable to Collateral Agent and provide for Borrower becoming cash flow positive prior to the Maturity Date, no later than thirty (30) days after the occurrence of the breach of the financial covenant and raising sufficient additional capital from the sale and issuance of Borrower’s equity securities as is required to fund such plan within sixty (60) days after the submission of such plan; provided, that upon such cure the parties shall amend the covenant in Section 6.12 in accordance with the new financial plan which amendment must be acceptable to Collateral Agent and shall, among other things, require Borrower to achieve the full net revenue projections set forth in the new financial plan; or

(b) Borrower, or any of its Subsidiaries, fails or neglects to perform, keep, or observe any other term, provision, condition, covenant or agreement contained in this Agreement or any Loan Documents, and as to any default (other than those specified in this Section 8) under such other term, provision, condition, covenant or agreement that can be cured, has failed to cure the default within fifteen (15) days after the Borrower becoming aware of the occurrence thereof; provided, however, that if the default cannot by its nature be cured within the fifteen (15) day period or cannot after diligent attempts by Borrower be cured within such fifteen (15) day period, and such default is likely to be cured within a reasonable time, then Borrower shall have an additional period (which shall not in any case exceed thirty (30) days) to attempt to cure such default, and within such reasonable time period the failure to cure the default shall not be deemed an Event of Default (but no Term Loan shall be made during such cure period);

8.3 MaterialAdverse Change. A Material Adverse Change has occurred**;**

8.4 Attachment;Levy; Restraint on Business.

(a) (i) The service of process seeking to attach, by trustee or similar process, any funds of Borrower or any of its Subsidiaries or of any entity under control of Borrower or its Subsidiaries on deposit with any institution at which Borrower or any of its Subsidiaries maintains a Collateral Account, or (ii) a notice of lien, levy, or assessment is filed against Borrower or any of its Subsidiaries or their respective assets by any government agency, and the same under subclauses (i) and (ii) hereof are not, within twenty (20) days after the occurrence thereof, discharged or stayed (whether through the posting of a bond or otherwise); and

(b) (i) any material portion of Borrower’s or any of its Subsidiaries’ assets is attached, seized, levied on, or comes into possession of a trustee or receiver, or (ii) any court order enjoins, restrains, or prevents Borrower or any of its Subsidiaries from conducting any part of its business;

8.5 Insolvency. (a) Borrower or any of its Subsidiaries is or becomes Insolvent; (b) Borrower or any of its Subsidiaries begins an Insolvency Proceeding; or (c) an Insolvency Proceeding is begun against Borrower or any of its Subsidiaries and not dismissed or stayed within forty-five (45) days (but no Term Loan shall be extended while Borrower or any Subsidiary is Insolvent and/or until any Insolvency Proceeding is dismissed);

8.6 OtherAgreements. There is a default in any agreement to which Borrower or any of its Subsidiaries is a party with a third party or parties resulting in a right by such third party or parties, whether or not exercised, to accelerate the maturity of any Indebtedness in an amount in excess of Two Hundred Fifty Thousand Dollars ($250,000.00) or that could reasonably be expected to have a Material Adverse Change.

8.7 Judgments. (a) One or more judgments, orders, or decrees for the payment of money in an amount, individually or in the aggregate, of at least Two Hundred Fifty Thousand Dollars ($250,000.00) (not covered by independent third party insurance) shall be rendered against Borrower or any of its Subsidiaries and shall remain unsatisfied, unvacated, or unstayed for a period of fifteen (15) days after the entry thereof or (b) any judgments, orders or decrees rendered against Borrower that could reasonably be expected to result in a Material Adverse Change;

8.8 Misrepresentations. Borrower or any of its Subsidiaries or any Person acting for Borrower or any of its Subsidiaries makes any representation, warranty, or other statement now or later in this Agreement, any Loan Document or in any writing delivered to Collateral Agent and/or Lenders or to induce Collateral Agent and/or the Lenders to enter this Agreement or any Loan Document, and such representation, warranty, or other statement, when taken as a whole, is incorrect in any material respect when made;

8.9 SubordinatedDebt. A default or breach occurs under any agreement between Borrower or any of its Subsidiaries and any creditor of Borrower or any of its Subsidiaries that signed a subordination, intercreditor, or other similar agreement with Collateral Agent or the Lenders, or any creditor that has signed such an agreement with Collateral Agent or the Lenders breaches any terms of such agreement, in each case where the aggregate outstanding Indebtedness of Borrower and its Subsidiaries to such creditor is in excess of Two Hundred Fifty Thousand Dollars ($250,000.00);

8.10 Guaranty. (a) Any Guaranty terminates or ceases for any reason to be in full force and effect; (b) any Guarantor does not perform any obligation or covenant under any Guaranty; (c) any circumstance described in Section 8 occurs with respect to any Guarantor; or (d) a Material Adverse Change with respect to any Guarantor;

8.11 GovernmentalApprovals; FDA Action. (a) Any Governmental Approval shall have been revoked, rescinded, suspended, modified in an adverse manner, or not renewed in the ordinary course for a full term and such revocation, rescission, suspension, modification or non renewal has resulted in or could reasonably be expected to result in a Material Adverse Change; or (b) (i) the FDA, DOJ, or other Governmental Authority initiates a Regulatory Action or any other enforcement action against Borrower or any of its Subsidiaries or any supplier of Borrower or any of its Subsidiaries that causes Borrower or any of its Subsidiaries to recall, withdraw, remove or discontinue manufacturing, distributing, and/or marketing any of its products, even if such action is based on previously disclosed conduct but only to the extent this has resulted in or could reasonably be expected to result in a Material Adverse Change; (ii) the FDA issues a warning letter or Regulatory Action to Borrower or any of its Subsidiaries with respect to any of its activities or products which could reasonably be expected to result in a Material Adverse Change; (iii) Borrower or any of its Subsidiaries conducts a mandatory or voluntary recall which could reasonably be expected to result in liability and expense to Borrower or any of its Subsidiaries of Five Hundred Thousand Dollars ($500,000.00) or more; (iv) Borrower or any of its Subsidiaries enters into a settlement agreement with the FDA, DOJ, or other Governmental Authority that results in aggregate liability as to any single or related series of transactions, incidents or conditions, of Five Hundred Thousand Dollars ($500,000.00) or more, or that could reasonably be expected to result in a Material Adverse Change even if such settlement agreement is based on previously disclosed conduct; or (v) Borrower or any of its Subsidiaries fails to remediate observations identified in an FDA Form 483 notice of inspection observation to Collateral Agent’s reasonable satisfaction within six months of receipt; or (vi) the FDA revokes any authorization or permission granted under any Registration, or Borrower or any of its Subsidiaries withdraws any Registration, that could reasonably be expected to result in a Material Adverse Change.

8.12 LienPriority; Intellectual Property. Any Lien created hereunder or by any other Loan Document shall at any time fail to constitute a valid and perfected Lien on any of the Collateral purported to be secured thereby, subject to no prior or equal Lien, other than Permitted Liens. Any Intellectual Property material to Borrower’s business shall cease to be validly owned or licensed by Borrower free and clear of any Liens other than Permitted Liens.

9.	RIGHTS AND REMEDIES

9.1 Rightsand Remedies.

(a) Upon the occurrence and during the continuance of an Event of Default, Collateral Agent may, without notice or demand, do any or all of the following: (i) deliver notice of the Event of Default to Borrower, (ii) by notice to Borrower declare all Obligations immediately due and payable (but if an Event of Default described in Section 8.5 occurs all Obligations shall be immediately due and payable without any action by Collateral Agent or the Lenders) or (iii) by notice to Borrower suspend or terminate the obligations, if any, of the Lenders to advance money or extend credit for Borrower’s benefit under this Agreement or under any other agreement between Borrower and Collateral Agent and/or the Lenders (but if an Event of Default described in Section 8.5 occurs all obligations, if any, of the Lenders to advance money or extend credit for Borrower’s benefit under this Agreement or under any other agreement between Borrower and Collateral Agent and/or the Lenders shall be immediately terminated without any action by Collateral Agent or the Lenders).

(b) Without limiting the rights of Collateral Agent and the Lenders set forth in Section 9.1(a) above, upon the occurrence and during the continuance of an Event of Default, Collateral Agent shall have the right, without notice or demand, to do any or all of the following:

(i) foreclose upon and/or sell or otherwise liquidate, the Collateral;

(ii) apply to the Obligations any (a) balances and deposits of Borrower that Collateral Agent or any Lender holds or controls, or (b) any amount held or controlled by Collateral Agent or any Lender owing to or for the credit or the account of Borrower; and/or

(iii) commence and prosecute an Insolvency Proceeding or consent to Borrower commencing any Insolvency Proceeding.

(c) Without limiting the rights of Collateral Agent and the Lenders set forth in Sections 9.1(a) and (b) above, upon the occurrence and during the continuance of an Event of Default, Collateral Agent shall have the right, without notice or demand, to do any or all of the following:

(i) settle or adjust disputes and claims directly with Account Debtors for amounts on terms and in any order that Collateral Agent considers advisable, notify any Person owing Borrower money of Collateral Agent’s security interest in such funds, and verify the amount of such account;

(ii) make any payments and do any acts it considers necessary or reasonable to protect the Collateral and/or its security interest in the Collateral. Borrower shall assemble the Collateral if Collateral Agent requests and make it available in a location as Collateral Agent reasonably designates. Collateral Agent may enter premises where the Collateral is located, take and maintain possession of any part of the Collateral, and pay, purchase, contest, or compromise any Lien which appears to be prior or superior to its security interest and pay all expenses incurred. Borrower grants Collateral Agent a license to enter and occupy any of its premises, without charge, to exercise any of Collateral Agent’s rights or remedies;

(iii) ship, reclaim, recover, store, finish, maintain, repair, prepare for sale, and/or advertise for sale, the Collateral. Collateral Agent is hereby granted a non-exclusive, royalty free license or other right to use, without charge, Borrower’s and each of its Subsidiaries’ labels, Patents, Copyrights, mask works, rights of use of any name, trade secrets, trade names, Trademarks, service marks, and advertising matter, or any similar property as it pertains to the Collateral, in completing production of, advertising for sale, and selling any Collateral and, in connection with Collateral Agent’s exercise of its rights under this Section 9.1, Borrower’s and each of its Subsidiaries’ rights under all licenses and all franchise agreements inure to Collateral Agent, for the benefit of the Lenders;

(iv) place a “hold” on any account maintained with Collateral Agent or the Lenders and/or deliver a notice of exclusive control, any entitlement order, or other directions or instructions pursuant to any Control Agreement or similar agreements providing control of any Collateral;

(v) demand and receive possession of Borrower’s Books;

(vi) appoint a receiver to seize, manage and realize any of the Collateral, and such receiver shall have any right and authority as any competent court will grant or authorize in accordance with any applicable law, including any power or authority to manage the business of Borrower or any of its Subsidiaries; and

(vii) subject to clauses 9.1(a) and (b), exercise all rights and remedies available to Collateral Agent and each Lender under the Loan Documents or at law or equity, including all remedies provided under the Code (including disposal of the Collateral pursuant to the terms thereof).

Notwithstanding any provision of this Section 9.1 to the contrary, upon the occurrence of any Event of Default, Collateral Agent shall have the right to exercise any and all remedies referenced in this Section 9.1 without the written consent of Required Lenders following the occurrence of an Exigent Circumstance.

9.2 Powerof Attorney. Borrower hereby irrevocably appoints Collateral Agent as its lawful attorney in fact, exercisable upon the occurrence and during the continuance of an Event of Default, to: (a) endorse Borrower’s or any of its Subsidiaries’ name on any checks or other forms of payment or security; (b) sign Borrower’s or any of its Subsidiaries’ name on any invoice or bill of lading for any Account or drafts against Account Debtors; (c) settle and adjust disputes and claims about the Accounts directly with Account Debtors, for amounts and on terms Collateral Agent determines reasonable; (d) make, settle, and adjust all claims under Borrower’s insurance policies; (e) pay, contest or settle any Lien, charge, encumbrance, security interest, and adverse claim in or to the Collateral, or any judgment based thereon, or otherwise take any action to terminate or discharge the same; and (f) transfer the Collateral into the name of Collateral Agent or a third party as the Code or any applicable law permits. Borrower hereby appoints Collateral Agent as its lawful attorney in fact, exercisable upon the occurrence and during the continuance of an Event of Default, to sign Borrower’s or any of its Subsidiaries’ name on any documents necessary to perfect or continue the perfection of Collateral Agent’s security interest in the Collateral regardless of whether an Event of Default has occurred until all Obligations (other than inchoate indemnity obligations) have been satisfied in full and Collateral Agent and the Lenders are under no further obligation to extend the Term Loan hereunder. Collateral Agent’s foregoing appointment as Borrower’s or any of its Subsidiaries’ attorney in fact, and all of Collateral Agent’s rights and powers, coupled with an interest, are irrevocable until all Obligations (other than inchoate indemnity obligations) have been fully repaid and performed and Collateral Agent’s and the Lenders’ obligation to provide the Term Loan terminates.

9.3 ProtectivePayments. If Borrower or any of its Subsidiaries fail to obtain the insurance called for by Section 6.5 or fails to pay any premium thereon or fails to pay any other amount which Borrower or any of its Subsidiaries is obligated to pay under this Agreement or any other Loan Document, Collateral Agent may obtain such insurance or make such payment, and all amounts so paid by Collateral Agent are Lenders’ Expenses and immediately due and payable, bearing interest at the Default Rate, and secured by the Collateral. Collateral Agent will make reasonable efforts to provide Borrower with notice of Collateral Agent obtaining such insurance or making such payment at the time it is obtained or paid or within a reasonable time thereafter. No such payments by Collateral Agent are deemed an agreement to make similar payments in the future or Collateral Agent’s waiver of any Event of Default.

9.4 Applicationof Payments and Proceeds. Notwithstanding anything to the contrary contained in this Agreement, upon the occurrence and during the continuance of an Event of Default, (a) Borrower irrevocably waives the right to direct the application of any and all payments at any time or times thereafter received by Collateral Agent from or on behalf of Borrower or any of its Subsidiaries of all or any part of the Obligations, and, as between Borrower on the one hand and Collateral Agent and Lenders on the other, Collateral Agent shall have the continuing and exclusive right to apply and to reapply any and all payments received against the Obligations in such manner as Collateral Agent may deem advisable notwithstanding any previous application by Collateral Agent, and (b) the proceeds of any sale of, or other realization upon all or any part of the Collateral shall be applied: first, to the Lenders’ Expenses; second, to accrued and unpaid interest on the Obligations (including any interest which, but for the provisions of the United States Bankruptcy Code, would have accrued on such amounts); third, to the principal amount of the Obligations outstanding; and fourth, to any other indebtedness or obligations of Borrower owing to Collateral Agent or any Lender under the Loan Documents. Any balance remaining shall be delivered to Borrower or to whoever may be lawfully entitled to receive such balance or as a court of competent jurisdiction may direct. In carrying out the foregoing, (x) amounts received shall be applied in the numerical order provided until exhausted prior to the application to the next succeeding category, and (y) each of the Persons entitled to receive a payment in any particular category shall receive an amount equal to its pro rata share of amounts available to be applied pursuant thereto for such category. Any reference in this Agreement to an allocation between or sharing by the Lenders of any right, interest or obligation “ratably,” “proportionally” or in similar terms shall refer to Pro Rata Share unless expressly provided otherwise. Collateral Agent, or if applicable, each Lender, shall promptly remit to the other Lenders such sums as may be necessary to ensure the ratable repayment of each Lender’s portion of any Term Loan and the ratable distribution of interest, fees and reimbursements paid or made by Borrower. Notwithstanding the foregoing, a Lender receiving a scheduled payment shall not be responsible for determining whether the other Lenders also received their scheduled payment on such date; provided, however, if it is later determined that a Lender received more than its ratable share of scheduled payments made on any date or dates, then such Lender shall remit to Collateral Agent or other Lenders such sums as may be necessary to ensure the ratable payment of such scheduled payments, as instructed by Collateral Agent. If any payment or distribution of any kind or character, whether in cash, properties or securities, shall be received by a Lender in excess of its ratable share, then the portion of such payment or distribution in excess of such Lender’s ratable share shall be received by such Lender in trust for and shall be promptly paid over to the other Lender for application to the payments of amounts due on the other Lenders’ claims. To the extent any payment for the account of Borrower is required to be returned as a voidable transfer or otherwise, the Lenders shall contribute to one another as is necessary to ensure that such return of payment is on a pro rata basis. If any Lender shall obtain possession of any Collateral, it shall hold such Collateral for itself and as agent and bailee for Collateral Agent and other Lenders for purposes of perfecting Collateral Agent’s security interest therein.

9.5 Liabilityfor Collateral. So long as Collateral Agent and the Lenders comply with reasonable banking practices regarding the safekeeping of the Collateral in the possession or under the control of Collateral Agent and the Lenders, Collateral Agent and the Lenders shall not be liable or responsible for: (a) the safekeeping of the Collateral; (b) any loss or damage to the Collateral; (c) any diminution in the value of the Collateral; or (d) any act or default of any carrier, warehouseman, bailee, or other Person. Borrower bears all risk of loss, damage or destruction of the Collateral.

9.6 NoWaiver; Remedies Cumulative. Failure by Collateral Agent or any Lender, at any time or times, to require strict performance by Borrower of any provision of this Agreement or any other Loan Document shall not waive, affect, or diminish any right of Collateral Agent or any Lender thereafter to demand strict performance and compliance herewith or therewith. No waiver hereunder shall be effective unless signed by Collateral Agent and the Required Lenders and then is only effective for the specific instance and purpose for which it is given. The rights and remedies of Collateral Agent and the Lenders under this Agreement and the other Loan Documents are cumulative. Collateral Agent and the Lenders have all rights and remedies provided under the Code, any applicable law, by law, or in equity. The exercise by Collateral Agent or any Lender of one right or remedy is not an election, and Collateral Agent’s or any Lender’s waiver of any Event of Default is not a continuing waiver. Collateral Agent’s or any Lender’s delay in exercising any remedy is not a waiver, election, or acquiescence.

9.7 DemandWaiver. Borrower waives, to the fullest extent permitted by law, demand, notice of default or dishonor, notice of payment and nonpayment, notice of any default, nonpayment at maturity, release, compromise, settlement, extension, or renewal of accounts, documents, instruments, chattel paper, and guarantees held by Collateral Agent or any Lender on which Borrower or any Subsidiary is liable.

10.	NOTICES

All notices, consents, requests, approvals, demands, or other communication (collectively, “Communication”) by any party to this Agreement or any other Loan Document must be in writing and shall be deemed to have been validly served, given, or delivered: (a) upon the earlier of actual receipt and three (3) Business Days after deposit in the U.S. mail, first class, registered or certified mail return receipt requested, with proper postage prepaid; (b) upon transmission, when sent by facsimile transmission; (c) one (1) Business Day after deposit with a reputable overnight courier with all charges prepaid; or (d) when delivered, if hand delivered by messenger, all of which shall be addressed to the party to be notified and sent to the address, facsimile number, or email address indicated below. Any of Collateral Agent, Lender or Borrower may change its mailing address or facsimile number by giving the other party written notice thereof in accordance with the terms of this Section 10.

If to Borrower:	MDXHEALTH SA<br><br> <br>MDxHealth, Inc.<br><br> <br>15279 Alton Parkway<br><br> <br>Suite 100<br><br> <br>Irvine, CA 92618<br><br> <br>Attn: General Counsel<br><br> <br>EMAIL: notice@mdxhealth.com
with a copy (which shall<br><br>not constitute notice) to:	[***]
If to Collateral Agent:	INNOVATUS LIFE SCIENCES<br><br> <br>LENDING FUND I, LP<br><br> <br>777 Third Avenue, 25th Floor<br><br> <br>New York, NY 10017<br><br> <br>Attn: Claes Ekstrom<br><br> <br>Email: [***]
with a copy (which shall<br><br>not constitute notice) to:	Greenberg Traurig, LLP<br><br> <br>One International Place<br><br> <br>Boston, MA 02110<br><br> <br>Attn: Abdullah Malik<br><br> <br>Fax: (617) 897-0983<br><br> <br>Email: [***]

11.	CHOICE OF LAW, VENUE AND JURY TRIAL WAIVER

11.1 Waiverof Jury Trial. EACH OF BORROWER, COLLATERAL AGENT AND LENDERS UNCONDITIONALLY WAIVES ANY AND ALL RIGHT TO A JURY TRIAL OF ANY CLAIM OR CAUSE OF ACTION BASED UPON OR ARISING OUT OF THIS AGREEMENT, ANY OF THE OTHER LOAN DOCUMENTS, ANY OF THE INDEBTEDNESS SECURED HEREBY, ANY DEALINGS AMONG BORROWER, COLLATERAL AGENT AND/OR LENDERS RELATING TO THE SUBJECT MATTER OF THIS TRANSACTION OR ANY RELATED TRANSACTIONS, AND/OR THE RELATIONSHIP THAT IS BEING ESTABLISHED AMONG BORROWER, COLLATERAL AGENT AND/OR LENDERS. THE SCOPE OF THIS WAIVER IS INTENDED TO BE ALL ENCOMPASSING OF ANY AND ALL DISPUTES THAT MAY BE FILED IN ANY COURT. THIS WAIVER IS IRREVOCABLE. THIS WAIVER MAY NOT BE MODIFIED EITHER ORALLY OR IN WRITING. THE WAIVER ALSO SHALL APPLY TO ANY SUBSEQUENT AMENDMENTS, RENEWALS, SUPPLEMENTS OR MODIFICATIONS TO THIS AGREEMENT, ANY OTHER LOAN DOCUMENTS, OR TO ANY OTHER DOCUMENTS OR AGREEMENTS RELATING TO THIS TRANSACTION OR ANY RELATED TRANSACTION. THIS AGREEMENT MAY BE FILED AS A WRITTEN CONSENT TO A TRIAL BY THE COURT.

11.2 GoverningLaw and Jurisdiction.

(a) THIS AGREEMENT, THE OTHER LOAN DOCUMENTS (EXCLUDING THOSE LOAN DOCUMENTS THAT BY THEIR OWN TERMS ARE EXPRESSLY GOVERNED BY THE LAWS OF ANOTHER JURISDICTION) AND THE RIGHTS AND OBLIGATIONS OF THE PARTIES HEREUNDER AND THEREUNDER SHALL IN ALL RESPECTS BE GOVERNED BY AND CONSTRUED IN ACCORDANCE WITH, THE INTERNAL LAWS OF THE STATE OF NEW YORK (WITHOUT REGARD TO THE CONFLICT OF LAWS PRINCIPLES THAT WOULD RESULT IN THE APPLICATION OF ANY LAWS OTHER THAN THE LAWS OF THE STATE OF NEW YORK), INCLUDING ALL MATTERS OF CONSTRUCTION, VALIDITY AND PERFORMANCE, REGARDLESS OF THE LOCATION OF THE COLLATERAL, PROVIDED, HOWEVER, THAT IF THE LAWS OF ANY JURISDICTION OTHER THAN NEW YORK SHALL GOVERN IN REGARD TO THE VALIDITY, PERFECTION OR EFFECT OF PERFECTION OF ANY LIEN OR IN REGARD TO PROCEDURAL MATTERS AFFECTING ENFORCEMENT OF ANY LIENS IN COLLATERAL, SUCH LAWS OF SUCH OTHER JURISDICTIONS SHALL CONTINUE TO APPLY TO THAT EXTENT.

(b) Submission to Jurisdiction. Any legal action or proceeding with respect to the Loan Documents shall be brought exclusively in the courts of the State of New York located in the City of New York, Borough of Manhattan, or of the United States of America for the Southern District of New York and, by execution and delivery of this Agreement, Borrower hereby accepts for itself and in respect of its Property, generally and unconditionally, the jurisdiction of the aforesaid courts. Notwithstanding the foregoing, Collateral Agent and Lenders shall have the right to bring any action or proceeding against Borrower (or any property of Borrower) in the court of any other jurisdiction Collateral Agent or Lenders deem necessary or appropriate in order to realize on the Collateral or other security for the Obligations. The parties hereto hereby irrevocably waive any objection, including any objection to the laying of venue or based on the grounds of forum non conveniens, that any of them may now or hereafter have to the bringing of any such action or proceeding in such jurisdictions.

(c) Service of Process. Borrower irrevocably waives personal service of any and all legal process, summons, notices and other documents and other service of process of any kind and consents to such service in any suit, action or proceeding brought in the United States of America with respect to or otherwise arising out of or in connection with any Loan Document by any means permitted by applicable requirements of law, including by the mailing thereof (by registered or certified mail, postage prepaid) to the address of Borrower specified herein (and shall be effective when such mailing shall be effective, as provided therein). Borrower agrees that a final judgment in any such action or proceeding shall be conclusive and may be enforced in other jurisdictions by suit on the judgment or in any other manner provided by law.

(d) Non-exclusive Jurisdiction. Nothing contained in this Section 11.2 shall affect the right of Collateral Agent or Lenders to serve process in any other manner permitted by applicable requirements of law or commence legal proceedings or otherwise proceed against Borrower in any other jurisdiction.

12.	GENERAL PROVISIONS

12.1 Successorsand Assigns. This Agreement binds and is for the benefit of the successors and permitted assigns of each party. Borrower may not transfer, pledge or assign this Agreement or any rights or obligations under it without Collateral Agent’s prior written consent (which may be granted or withheld in Collateral Agent’s discretion, subject to Section 12.5). The Lenders have the right, without the consent of or notice to Borrower, to sell, transfer, assign, pledge, negotiate, or grant participation in (any such sale, transfer, assignment, negotiation, or grant of a participation, a “Lender Transfer”) all or any part of, or any interest in, the Lenders’ obligations, rights, and benefits under this Agreement and the other Loan Documents; provided, however, no Lender shall, other than upon the occurrence and during the continuation of an Event of Default, assign or transfer any part of the Lenders’ obligations, rights, and benefits under this Agreement and the other Loan Documents to a direct competitor of any Borrower or to any vulture hedge fund.

The Persons who become a Lender after the date of this Agreement expressly waive any priority of ranking they may have in connection with the Loan Documents pursuant to the Belgian Act of 3 August 2012 on various measures to facilitate the mobilisation of receivables in the financial sector (Wet van 3 augustus 2012 betreffende diverse maatregelen ter vergemakkelijking van de mobilisering van schuldvorderingen in de financiële sector/ Loi du 3 août 2012 relative à des mesures diverses pour faciliter la mobilisation de créances dans le secteur financier) and/or the Belgian Act of 4 August 1992 on mortgage credit (Wet van 4 augustus 1992 op het hypothecair krediet/Loi du 4 août 1992 relative au crédit hypothécaire).

The benefit of the Collateral Agent’s Lien in the Collateral shall automatically transfer to any successor or assign (by way of novation or otherwise) of part or all of the obligations expressed to be secured by that Lien. To the extent necessary, the Parties expressly state for the purposes of Article 1278 and 1281 of the Belgian Civil Code that that Lien will continue to secure any novated claim, and that no Borrower is discharged by that novation.

12.2 Non-CooperativeJurisdictions. Notwithstanding Section 12.1 above, no such Lender Transfer may be effected without the prior consent of the Parent if at the time of the Lender Transfer (i) the state or territory in which the relevant transferee (the “New Lender”) is incorporated, or has its place of effective management or its permanent establishment, is a Non-Cooperative Jurisdiction; or (ii) the bank account(s) to which payments to which that New Lender will be entitled will be made, are (A) managed or held by a person or persons incorporated, resident or established in a Non-Cooperative Jurisdiction or by the permanent establishment of a non-resident of Belgium situated in a Non-Cooperative Jurisdiction; or (B) managed by, or opened with, (1) a financial institution incorporated, resident or established in a Non-Cooperative Jurisdiction or (2) a branch or office of a financial institution situated in a Non-Cooperative Jurisdiction.

If the Parent receives a written request for its consent (which shall refer to this Section 12.2), it must within five Business Days either grant its written consent, or request additional information reasonably demonstrating that the New Lender does not qualify as an artificial construction within the meaning of Article 198, §1, 10° of the Belgian Income Tax Code 1992. The Parent is deemed to have granted its consent if it has not granted its written consent or has not requested any such additional information within five Business Days. If the Parent requested and received additional information that is reasonably satisfactory to it, it must grant its written consent. The Parent is deemed to have granted its consent ten Business Days after it received additional information, unless it has notified its duly motivated refusal within that time.

12.3 Indemnification. Borrower agrees to indemnify, defend and hold Collateral Agent and the Lenders and their respective directors, officers, employees, consultants, agents, attorneys, or any other Person affiliated with or representing Collateral Agent or the Lenders (each, an “IndemnifiedPerson”) harmless against: (a) all obligations, demands, claims, and liabilities (collectively, “Claims”) asserted by any third party in connection with; related to; following; or arising from, out of or under, the transactions contemplated by the Loan Documents; and (b) all losses or Lenders’ Expenses incurred, or paid by Indemnified Person in connection with; related to; following; or arising from, out of or under, the transactions contemplated by the Loan Documents between Collateral Agent, and/or the Lenders and Borrower (including reasonable attorneys’ fees and expenses), except for Claims and/or losses directly caused by such Indemnified Person’s gross negligence or willful misconduct. Borrower hereby further indemnifies, defends and holds each Indemnified Person harmless from and against any and all liabilities, obligations, losses, damages, penalties, actions, judgments, suits, claims, costs, expenses and disbursements of any kind or nature whatsoever (including the fees and disbursements of counsel for such Indemnified Person) in connection with any investigative, response, remedial, administrative or judicial matter or proceeding, whether or not such Indemnified Person shall be designated a party thereto and including any such proceeding initiated by or on behalf of Borrower, and the reasonable expenses of investigation by engineers, environmental consultants and similar technical personnel and any commission, fee or compensation claimed by any broker (other than any broker retained by Collateral Agent or Lenders) asserting any right to payment for the transactions contemplated hereby which may be imposed on, incurred by or asserted against such Indemnified Person as a result of or in connection with the transactions contemplated hereby and the use or intended use of the proceeds of the loan proceeds except for liabilities, obligations, losses, damages, penalties, actions, judgments, suits, claims, costs, expenses and disbursements directly caused by such Indemnified Person’s gross negligence or willful misconduct.

If an Indemnified Person is or will be subject to any liability, or required to make any payment for or on account of tax in relation to a sum received or receivable (or any sum deemed for the purposes of tax to be received or receivable) under a Loan Document, then the Borrower shall (within five Business Days of demand by the Lender) pay to the Lender an amount equal to the loss, liability or cost which the Lender determines will be or has been (directly or indirectly) suffered for or on account of Tax by it in respect of a Finance Document.

This above paragraph above shall not apply:

(a) with respect to any tax assessed on the Indemnified Person, (i) under the law of the jurisdiction in which the Indemnified Person is incorporated or, if different, the jurisdiction (or jurisdictions) in which the Indemnified Person is treated as resident for tax purposes or (ii) under the law of the jurisdiction in which the Indemnified Person’s Facility Office is located in respect of amounts received or receivable in that jurisdiction, if that tax is imposed on or calculated by reference to the net income received or receivable (but not any sum deemed to be received or receivable) by the Lender; or

(b) to the extent a loss, liability or cost is compensated for by an increased payment under Clause 2.5 or would have been compensated for by an increased payment under Clause 2.5 but was not so compensated solely because one of the exclusions mentioned in paragraph (a) and (b) of Clause 2.5 applied.

Notwithstanding any other provision, the Borrower shall pay and, within five Business Days of demand, indemnify the Lender against any cost, loss or liability that Lender incurs in relation to all stamp duty, registration and other similar taxes payable in respect of any Loan Document.

12.4 Severability ofProvisions. Each provision of this Agreement is severable from every other provision in determining the enforceability of any provision.

12.5 Correction ofLoan Documents. Collateral Agent may correct patent errors and fill in any blanks in this Agreement and the other Loan Documents consistent with the agreement of the parties.

12.6 Amendmentsin Writing; Integration. (a) No amendment, modification, termination or waiver of any provision of this Agreement or any other Loan Document, no approval or consent thereunder, or any consent to any departure by Borrower or any of its Subsidiaries therefrom, shall in any event be effective unless the same shall be in writing and signed by Borrower, Collateral Agent and the Required Lenders provided that:

(i) no such amendment, waiver or other modification that would have the effect of increasing or reducing a Lender’s Term Loan Commitment or Commitment Percentage shall be effective as to such Lender without such Lender’s written consent;

(ii) no such amendment, waiver or modification that would affect the rights and duties of Collateral Agent shall be effective without Collateral Agent’s written consent or signature; and

(iii) no such amendment, waiver or other modification shall, unless signed by all the Lenders directly affected thereby, (A) reduce the principal of, rate of interest on or any fees with respect to any Term Loan or forgive any principal, interest (other than default interest) or fees (other than late charges) with respect to any Term Loan (B) postpone the date fixed for, or waive, any payment of principal of any Term Loan or of interest on any Term Loan (other than default interest) or any fees provided for hereunder (other than late charges or for any termination of any commitment); (C) change the definition of the term “Required Lenders” or the percentage of Lenders which shall be required for the Lenders to take any action hereunder; (D) release all or substantially all of any material portion of the Collateral, authorize Borrower to sell or otherwise dispose of all or substantially all or any material portion of the Collateral or release any Guarantor of all or any portion of the Obligations or its guaranty obligations with respect thereto, except, in each case with respect to this clause (D), as otherwise may be expressly permitted under this Agreement or the other Loan Documents (including in connection with any disposition permitted hereunder); (E) amend, waive or otherwise modify this Section 12.5 or the definitions of the terms used in this Section 12.5 insofar as the definitions affect the substance of this Section 12.5; (F) consent to the assignment, delegation or other transfer by Borrower of any of its rights and obligations under any Loan Document or release Borrower of its payment obligations under any Loan Document, except, in each case with respect to this clause (F), pursuant to a merger or consolidation permitted pursuant to this Agreement; (G) amend any of the provisions of Section 9.4 or amend any of the definitions of Pro Rata Share, Term Loan Commitment, Commitment Percentage or that provide for the Lenders to receive their Pro Rata Shares of any fees, payments, setoffs or proceeds of Collateral hereunder; (H) subordinate the Liens granted in favor of Collateral Agent securing the Obligations; or (I) amend any of the provisions of Section 12.5. It is hereby understood and agreed that all Lenders shall be deemed directly affected by an amendment, waiver or other modification of the type described in the preceding clauses (C), (D), (E), (F), (G) and (H) of the immediately preceding sentence.

(b) Other than as expressly provided for in Section 12.5(a)(i) (iii), Collateral Agent may, if requested by the Required Lenders, from time to time designate covenants in this Agreement less restrictive by notification to a representative of Borrower.

(c) This Agreement and the Loan Documents represent the entire agreement about this subject matter and supersede prior negotiations or agreements with respect to such subject matter. All prior agreements, understandings, representations, warranties, and negotiations between the parties about the subject matter of this Agreement and the Loan Documents merge into this Agreement and the Loan Documents.

12.7 Counterparts. This Agreement may be executed in any number of counterparts and by different parties on separate counterparts, each of which, when executed and delivered, is an original, and all taken together, constitute one Agreement.

12.8 Survival. All covenants, representations and warranties made in this Agreement continue in full force and effect until this Agreement has terminated pursuant to its terms and all Obligations (other than inchoate indemnity obligations and any other obligations which, by their terms, are to survive the termination of this Agreement) have been satisfied. The obligation of Borrower in Section 12.2 to indemnify each Lender and Collateral Agent, as well as the confidentiality provisions in Section 12.8 below, shall survive until the statute of limitations with respect to such claim or cause of action shall have run.

12.9 Confidentiality. In handling any confidential information of Borrower, the Lenders and Collateral Agent shall exercise the same degree of care that it exercises for their own proprietary information, but disclosure of information may be made: (a) subject to the terms and conditions of this Agreement, to the Lenders’ and Collateral Agent’s Subsidiaries or Affiliates, such Confidential Information as the Lender or Collateral Agent shall consider appropriate if any person to whom the Confidential Information is to be given pursuant to this paragraph (a) is informed of its confidential nature and that some or all of such Confidential Information may be price-sensitive information except that there shall be no such requirement to so inform if the recipient is subject to professional obligations to maintain the confidentiality of the information or is otherwise bound by requirements of confidentiality in relation to the Confidential Information; (b) to prospective transferees (other than those identified in (a) above) or purchasers of any interest in the Term Loan (provided, however, (i) if, at the applicable time, an Event of Default has occurred and is outstanding, the Lenders and Collateral Agent shall advise such prospective transferee or purchaser about the confidential nature of such information and (ii) if, at the applicable time, no Event of Default has occurred and is continuing, obtain such prospective transferee’s or purchaser’s agreement to the terms of this provision or to similar confidentiality terms); (c) as required by law, regulation, subpoena, or other order; (d) to Lenders’ or Collateral Agent’s regulators or as otherwise required in connection with an examination or audit; (e) as Collateral Agent reasonably considers appropriate in exercising remedies under the Loan Documents; and (f) to third party service providers of the Lenders and/or Collateral Agent so long as such service providers have executed a confidentiality agreement or have agreed to similar confidentiality terms with the Lenders and Collateral Agent with terms no less restrictive than those contained herein. Confidential information does not include information that either: (i) is in the public domain or in the Lenders’ and/or Collateral Agent’s possession when disclosed to the Lenders and/or Collateral Agent, or becomes part of the public domain after disclosure to the Lenders and/or Collateral Agent at no fault of the Lenders or the Collateral Agent; or (ii) is disclosed to the Lenders and/or Collateral Agent by a third party, if the Lenders and/or Collateral Agent does not know that the third party is prohibited from disclosing the information. Collateral Agent and the Lenders may use confidential information for any purpose, including, without limitation, for the development of client databases, reporting purposes, and market analysis. The provisions of the immediately preceding sentence shall survive the termination of this Agreement. The agreements provided under this Section 12.8 supersede all prior agreements, understanding, representations, warranties, and negotiations between the parties about the subject matter of this Section 12.8.

Each of the Lenders and the Collateral Agent acknowledges that some or all of the Confidential Information is or may be price-sensitive information and that the use of such information may be regulated or prohibited by applicable legislation including securities law relating to insider dealing and market abuse and each of the Lenders and the Collateral Agent undertakes not to use any Confidential Information for any unlawful purposes.

Each of the Lenders agrees (to the extent permitted by law and regulation) to inform the Parent (a) of the circumstances of any disclosure of Confidential Information made pursuant to paragraphs (c) or (d) above except where such disclosure is made to any of the persons referred to in that paragraph during the ordinary course of its supervisory or regulatory function and upon becoming aware that Confidential Information has been disclosed in breach of this Section 12.9.

12.10 Rightof Set Off. Borrower hereby grants to Collateral Agent and to each Lender, a lien, security interest and right of set off as security for all Obligations to Collateral Agent and each Lender hereunder, whether now existing or hereafter arising upon and against all deposits, credits, collateral and property, now or hereafter in the possession, custody, safekeeping or control of Collateral Agent or the Lenders or any entity under the control of Collateral Agent or the Lenders (including a Collateral Agent affiliate) or in transit to any of them. At any time after the occurrence and during the continuance of an Event of Default, without demand or notice, Collateral Agent or the Lenders may set off the same or any part thereof and apply the same to any liability or obligation of Borrower even though unmatured and regardless of the adequacy of any other collateral securing the Obligations. ANY AND ALL RIGHTS TO REQUIRE COLLATERAL AGENT TO EXERCISE ITS RIGHTS OR REMEDIES WITH RESPECT TO ANY OTHER COLLATERAL WHICH SECURES THE OBLIGATIONS, PRIOR TO EXERCISING ITS RIGHT OF SETOFF WITH RESPECT TO SUCH DEPOSITS, CREDITS OR OTHER PROPERTY OF BORROWER ARE HEREBY KNOWINGLY, VOLUNTARILY AND IRREVOCABLY WAIVED BY BORROWER.

12.11 Cooperationof Borrower. If necessary, Borrower agrees to (i) execute any documents reasonably required to effectuate and acknowledge each assignment of a Term Loan Commitment or Term Loan to an assignee in accordance with Section 12.1, (ii) make Borrower’s management available to meet with Collateral Agent and prospective participants and assignees of Term Loan Commitments (which meetings shall be conducted no more often than once every twelve months unless an Event of Default has occurred and is continuing), and (iii) assist Collateral Agent or the Lenders in the preparation of information relating to the financial affairs of Borrower as any prospective participant or assignee of a Term Loan Commitment or Term Loan reasonably may request. Subject to the provisions of Section 12.9, Borrower authorizes each Lender to disclose to any prospective participant or assignee of a Term Loan Commitment, any and all information in such Lender’s possession concerning Borrower and its financial affairs which has been delivered to such Lender by or on behalf of Borrower pursuant to this Agreement, or which has been delivered to such Lender by or on behalf of Borrower in connection with such Lender’s credit evaluation of Borrower prior to entering into this Agreement.

12.12 PublicAnnouncement. Borrower hereby agrees that after Borrower has publicly disclosed the transactions contemplated by this Agreement on the internet at Borrower’s website address or on the Securities and Exchange Commission’s website at www.sec.gov (or any similar Governmental Authority’s website in Belgium), Collateral Agent may publicize the same by means of a tombstone advertisement on Collateral Agent’s website and use Borrower’s name, tradenames and logos in connection therewith.

12.13 CollateralAgent and Lender Agreement. Collateral Agent and each Lender hereby agree to the terms and conditions set forth on Annex I attached hereto. Borrower acknowledges and agrees to the terms and conditions set forth on Annex I attached hereto.

12.14 BorrowerLiability. Either Borrower may, acting singly, request Credit Extensions hereunder. Each Borrower hereby appoints the other as agent for the other for all purposes hereunder, including with respect to requesting Credit Extensions hereunder. Each Borrower hereunder shall be jointly and severally obligated to repay all Credit Extensions made hereunder, regardless of which Borrower actually receives said Credit Extension, as if each Borrower hereunder directly received all Credit Extensions. Each Borrower waives (a) any suretyship defenses available to it under the Code or any other applicable law, and (b) any right to require Collateral Agent or any Lender to: (i) proceed against any Borrower or any other person; (ii) proceed against or exhaust any security; or (iii) pursue any other remedy. Collateral Agent and or any Lender may exercise or not exercise any right or remedy it has against any Borrower or any security it holds (including the right to foreclose by judicial or non-judicial sale) without affecting any Borrower’s liability. Notwithstanding any other provision of this Agreement or other related document, each Borrower irrevocably waives all rights that it may have at law or in equity (including, without limitation, any law subrogating Borrower to the rights of Collateral Agent and the Lenders under this Agreement) to seek contribution, indemnification or any other form of reimbursement from any other Borrower, or any other Person now or hereafter primarily or secondarily liable for any of the Obligations, for any payment made by Borrower with respect to the Obligations in connection with this Agreement or otherwise and all rights that it might have to benefit from, or to participate in, any security for the Obligations as a result of any payment made by Borrower with respect to the Obligations in connection with this Agreement or otherwise. Any agreement providing for indemnification, reimbursement or any other arrangement prohibited under this Section shall be null and void. If any payment is made to a Borrower in contravention of this Section, such Borrower shall hold such payment in trust for Collateral Agent and the Lenders and such payment shall be promptly delivered to Collateral Agent for application to the Obligations, whether matured or unmatured.

13.	DEFINITIONS

As used in this Agreement, the following terms have the following meanings:

“Account” is any “account” as defined in the Code with such additions to such term as may hereafter be made, and includes, without limitation, all accounts receivable and other sums owing to Borrower.

“Account Debtor” is any “account debtor” as defined in the Code with such additions to such term as may hereafter be made under the Code.

“Acquisition Documents” are the final execution versions (provided by Borrower to Collateral Agent prior to the Effective Date) of the Asset Purchase Agreement and related documents, between Borrower, Genomic Health, Inc. and other parties party thereto, related to the acquisition of all assets of Genomic Health, Inc. related to the product Oncotype DX GPS.

“Affiliate” of any Person is a Person that owns or controls directly or indirectly the Person, any Person that controls or is controlled by or is under common control with the Person, and each of that Person’s senior executive officers, directors, partners if such Person is a partnership and, for any Person that is a limited liability company, that Person’s managers and members.

“Amortization Date” is September 1, 2026.

“Anti Terrorism Laws” are any laws relating to terrorism or money laundering, including without limitation Executive Order No. 13224 (effective September 24, 2001), the USA PATRIOT Act, the laws comprising or implementing the Bank Secrecy Act, and the laws administered by OFAC.

“Basic Rate” is with respect to each Term Loan, the floating per annum rate of interest (based on a year of three hundred sixty five (365) days) equal to the sum of (a) the greater of (i) Prime Rate, subject to Section 2.3(f), or (ii) Four percent (4.00%), plus (b) Four and twenty-five hundredths percent (4.25%).

“BEPS” means base erosion and profit shifting.

“BEPS-Related Change” means a change in (or in the interpretation, administration, or application of) any law or Treaty or any published practice or published concession of any relevant taxing authority as a result of the ratification or entering into force of the MLI and which relates to Article 7 of the MLI.

“Blocking Law” means any provision of Council Regulation (EC) No 2271/1996 of 22 November 1996 (or any law or regulation implementing such Regulation in any member state of the European Union or the United Kingdom) or any similar blocking law.

“Blocked Person” is any Person: (a) listed in the annex to, or is otherwise subject to the provisions of, Executive Order No. 13224, (b) a Person owned or controlled by, or acting for or on behalf of, any Person that is listed in the annex to, or is otherwise subject to the provisions of, Executive Order No. 13224, (c) a Person with which any Lender is prohibited from dealing or otherwise engaging in any transaction by any Anti Terrorism Law, (d) a Person that commits, threatens or conspires to commit or supports “terrorism” as defined in Executive Order No. 13224, or (e) a Person that is named a “specially designated national” or “blocked person” on the most current list published by OFAC or other similar list.

“Borrower’s Books” are Borrower’s or any of its Subsidiaries’ books and records including ledgers, federal, and state tax returns, records regarding Borrower’s or its Subsidiaries’ assets or liabilities, the Collateral, business operations or financial condition, and all computer programs or storage or any equipment containing such information.

“Business Day” is any day that is not a Saturday, Sunday or a day on which Collateral Agent is closed.

“Cash Equivalents” are (a) marketable direct obligations issued or unconditionally guaranteed by the United States or any agency or any State thereof, the United Kingdom, or any member state of the European Union having maturities of not more than one (1) year from the date of acquisition; (b) commercial paper maturing no more than one (1) year after its creation and having the highest rating from either Standard & Poor’s Ratings Group or Moody’s Investors Service, Inc., and (c) certificates of deposit maturing no more than one (1) year after issue provided that the account in which any such certificate of deposit is maintained is subject to a Control Agreement in favor of Collateral Agent.

“Code” is the Uniform Commercial Code, as the same may, from time to time, be enacted and in effect in the State of New York; provided, that, to the extent that the Code is used to define any term herein or in any Loan Document and such term is defined differently in different Articles or Divisions of the Code, the definition of such term contained in Article or Division 9 shall govern; provided further, that in the event that, by reason of mandatory provisions of law, any or all of the attachment, perfection, or priority of, or remedies with respect to, Collateral Agent’s Lien on any Collateral is governed by the Uniform Commercial Code in effect in a jurisdiction other than the State of New York, the term “Code” shall mean the Uniform Commercial Code as enacted and in effect in such other jurisdiction solely for purposes of the provisions thereof relating to such attachment, perfection, priority, or remedies and for purposes of definitions relating to such provisions.

“Collateral” is any and all properties, rights and assets of Borrower described on Exhibit A.

“Collateral Account” is any Deposit Account, Securities Account, or Commodity Account, or any other bank account maintained by Borrower or any Subsidiary at any time.

“Commitment Percentage” is set forth in Schedule 1.1, as amended from time to time.

“Commodity Account” is any “commodity account” as defined in the Code with such additions to such term as may hereafter be made under the Code.

“Compliance Certificate” is that certain certificate in substantially the form attached hereto as Exhibit C.

“Contingent Obligation” is, for any Person, any direct or indirect liability, contingent or not, of that Person for (a) any indebtedness, lease, dividend, letter of credit or other obligation of another Person such as an obligation directly or indirectly guaranteed, endorsed, co made, discounted or sold with recourse by that Person, or for which that Person is directly or indirectly liable; (b) any obligations for undrawn letters of credit for the account of that Person; and (c) all obligations from any interest rate, currency or commodity swap agreement, interest rate cap or collar agreement, or other agreement or arrangement designated to protect a Person against fluctuation in interest rates, currency exchange rates or commodity prices; but “Contingent Obligation” does not include endorsements in the ordinary course of business. The amount of a Contingent Obligation is the stated or determined amount of the primary obligation for which the Contingent Obligation is made or, if not determinable, the maximum reasonably anticipated liability for it determined by the Person in good faith; but the amount may not exceed the maximum of the obligations under any guarantee or other support arrangement.

“Control Agreement” is any control agreement entered into among the depository institution at which Borrower or any of its Subsidiaries maintains a Deposit Account or the securities intermediary or commodity intermediary at which Borrower or any of its Subsidiaries maintains a Securities Account or a Commodity Account, Borrower and such Subsidiary, and Collateral Agent pursuant to which Collateral Agent, for the benefit of the Lenders, obtains “control” (within the meaning of the Code) over such Deposit Account, Securities Account, or Commodity Account.

“Copyrights” are any and all copyright rights, copyright applications, copyright registrations and like protections in each work of authorship and derivative work thereof, whether published or unpublished and whether or not the same also constitutes a trade secret.

“Credit Extension” is any Term Loan made hereunder.

“Default” means any event or condition that with notice, lapse of time or both would become an Event of Default.

“Deposit Account” is any “deposit account” as defined in the Code with such additions to such term as may hereafter be made.

“Disbursement Letter” is that certain form attached hereto as EXHIBIT B-2.

“DOJ” means the U.S. Department of Justice or any successor thereto or any other comparable Governmental Authority.

“Dollars,” “dollars” and “$” each mean lawful money of the United States.

“Equipment” is all “equipment” as defined in the Code with such additions to such term as may hereafter be made, and includes without limitation all machinery, fixtures, goods, vehicles (including motor vehicles and trailers), and any interest in any of the foregoing.

“ERISA” is the Employee Retirement Income Security Act of 1974, as amended, and its regulations.

“Exigent Circumstance” means any event or circumstance that, in the reasonable judgment of Collateral Agent, imminently threatens the ability of Collateral Agent to realize upon all or any material portion of the Collateral, such as, without limitation, fraudulent removal, concealment, or abscondment thereof, destruction or material waste thereof, or failure of Borrower or any of its Subsidiaries after reasonable demand to maintain or reinstate adequate casualty insurance coverage, or which, in the judgment of Collateral Agent, could reasonably be expected to result in a material diminution in value of the Collateral.

“Existing Indebtedness” is the indebtedness of Borrower to Kreos Capital VI (UK) Limited in the aggregate principal outstanding amount as of the Effective Date of approximately Nine Million Euros pursuant to that certain loan agreement, dated September 23, 2019, entered into by and between Kreos Capital VI (UK) Limited and Borrower

“Facility Fee” is a fee payable to each Lender: (i) due on the Funding Date of Term A Loan equal to one percent (1.00%) of the total Term Loan Commitment with respect to Term A Loan of such Lender and (ii) due on the Funding Date of Term B Loan equal to one percent (1.00%) of the total applicable Term Loan Commitment with respect to Term B Loan of such Lender.

“FDA” means the U.S. Food and Drug Administration or any successor thereto or any other comparable Governmental Authority.

“Final Fee” is a payment (in addition to and not a substitution for the regular monthly payments of principal plus accrued interest or any other fee payable hereunder) due on the earliest to occur of (a) the Maturity Date, or (b) the acceleration of any Term Loan, or (c) the prepayment of the Term Loan pursuant to Section 2.2(c) or (d), in each case equal to Final Fee Percentage multiplied by the aggregate amount of the Term Loans funded (minus such amount, if any, as has been converted pursuant to Section 2.10), payable to Lenders in accordance with their respective Pro Rata Shares.

“Final Fee Percentage” is five percent (5.00%).

“Foreign Currency” means lawful money of a country other than the United States.

“Foreign Subsidiary” is a Subsidiary that is not an entity organized under the laws of the United States or any state thereof.

“Funding Date” is any date on which the Term Loan is made to or on account of Borrower which shall be a Business Day.

“General Intangibles” are all “general intangibles” as defined in the Code in effect on the date hereof with such additions to such term as may hereafter be made, and includes without limitation, all copyright rights, copyright applications, copyright registrations and like protections in each work of authorship and derivative work, whether published or unpublished, any patents, trademarks, service marks and, to the extent permitted under applicable law, any applications therefor, whether registered or not, any trade secret rights, including any rights to unpatented inventions, payment intangibles, royalties, contract rights, goodwill, franchise agreements, purchase orders, customer lists, route lists, telephone numbers, domain names, claims, income and other tax refunds, security and other deposits, options to purchase or sell real or personal property, rights in all litigation presently or hereafter pending (whether in contract, tort or otherwise), insurance policies (including without limitation key man, property damage, and business interruption insurance), payments of insurance and rights to payment of any kind.

“Governmental Approval” is any consent, authorization, approval, order, license, franchise, permit, certificate, accreditation, registration, filing or notice, of, issued by or from, or other act by or in respect of, any Governmental Authority.

“Governmental Authority” is any nation or government, any state or other political subdivision thereof, any agency, authority, instrumentality, regulatory body (including, without limitation, the FDA and any state board of pharmacy or state pharmacy licensing authority), court, central bank or other entity exercising executive, legislative, judicial, taxing, regulatory or administrative functions of or pertaining to government (in each case, only to the extent that the rules, regulations or orders of such entity have the force of law), any securities exchange and any self-regulatory organization (to the extent that the rules, regulations or orders of such organization have the force of law).

“Guarantor” is any Person providing a Guaranty in favor of Collateral Agent for the benefit of the Lenders.

“Guaranty” is any guarantee of all or any part of the Obligations, as the same may from time to time be amended, restated, modified or otherwise supplemented.

“IFRS” means international accounting standards within the meaning of IAS Regulation 1606/2002 to the extent applicable to the relevant financial statements; or after written notice from Borrower to Collateral Agent shall mean GAAP with the commencement of the then next fiscal year of Borrower.

“Indebtedness” is (a) indebtedness for borrowed money or the deferred price of property or services, such as reimbursement and other obligations for surety bonds and letters of credit, (b) obligations evidenced by notes, bonds, debentures or similar instruments, (c) capital lease obligations, and (d) Contingent Obligations.

“Indirect Taxes” means any goods and services tax, consumption tax, value added tax or any similar tax.

“Insolvency Proceeding” is any proceeding by or against any Person under the United States Bankruptcy Code, or any other bankruptcy or insolvency law, including assignments for the benefit of creditors, compositions or proceedings seeking reorganization, arrangement, or other relief.

“Insolvent” means not Solvent.

“Intellectual Property” means all of Borrower’s or any of its Subsidiaries’ right, title and interest in and to the following:

(a) its Copyrights, Trademarks and Patents;

(b) any and all trade secrets and trade secret rights, including, without limitation, any rights to unpatented inventions, know how, operating manuals;

(d) any and all design rights which may be available to Borrower;

(e) any and all claims for damages by way of past, present and future infringement of any of the foregoing, with the right, but not the obligation, to sue for and collect such damages for said use or infringement of the Intellectual Property rights identified above;

(f) all amendments, renewals and extensions of any of the Copyrights, Trademarks or Patents; and

(g) all licenses, sublicenses or other contracts under which Borrower or any Subsidiary is granted rights by third parties in any Intellectual Property asset.

“Inventory” is all “inventory” as defined in the Code in effect on the date hereof with such additions to such term as may hereafter be made under the Code, and includes without limitation all merchandise, raw materials, parts, supplies, packing and shipping materials, work in process and finished products, including without limitation such inventory as is temporarily out of any Person’s custody or possession or in transit and including any returned goods and any documents of title representing any of the above.

“Investment” is any beneficial ownership interest in any Person (including stock, partnership interest or other securities), and any loan, advance or capital contribution to any Person.

“IP Security Agreement” is that certain Intellectual Property Security Agreement executed and delivered by Borrower to Collateral Agent and dated as of the Effective Date, as may be amended, restated, or otherwise modified or supplemented from time to time.

“Key Person” is each of Borrower’s (i) Chief Executive Officer, who is Michael McGarrity as of the Effective Date, and (ii) Chief Financial Officer, who is Ron Kalfus as of the Effective Date.

“Knowledge” means to the “best of” Borrower’s knowledge, or with a similar qualification, knowledge or awareness means the actual knowledge, after reasonable investigation, of the Responsible Officers.

“Kreos Discretionary Convertible Debt” is unsecured discretionary convertible debt of Borrower to Kreos Capital VI (UK) Limited in the aggregate outstanding amount of EUR 428,316.

“Lender” is any one of the Lenders.

“Lenders” are the Persons identified on Schedule 1.1 hereto and each assignee that becomes a party to this Agreement pursuant to Section 12.1.

“Lenders’ Expenses” are all audit fees and expenses, costs, and expenses (including reasonable attorneys’ fees and expenses, as well as appraisal fees, fees incurred on account of lien searches, inspection fees, and filing fees) for preparing, amending, negotiating, administering, defending and enforcing the Loan Documents (including, without limitation, those incurred in connection with appeals or Insolvency Proceedings) or otherwise incurred by Collateral Agent and/or the Lenders in connection with the Loan Documents.

“Lien” is a claim, mortgage, deed of trust, levy, charge, pledge, security interest, or other encumbrance of any kind, whether voluntarily incurred or arising by operation of law or otherwise against any property.

“Loan Documents” are, collectively, this Agreement, the IP Security Agreement, each Secured Promissory Note, the Perfection Certificate(s), each Control Agreement, each Compliance Certificate, each Loan Payment Request Form, each Disbursement Letter, any subordination agreements, any note, or notes or guaranties executed by Borrower or any other Person, and any other present or future agreement entered into by Borrower, any Guarantor or any other Person for the benefit of the Lenders and Collateral Agent in connection with this Agreement; all as amended, restated, or otherwise modified or supplemented from time to time.

“Loan Payment Request Form” is that certain form attached hereto as EXHIBIT B-1.

“Management Plan” is Borrower’s projected revenue attached hereto as Annex X, prepared and approved by the Borrower’s Board of Directors in connection with the commencement of the covenant in Section 6.12.

“Material Adverse Change” is (a) a material adverse change in the business, operations or condition (financial or otherwise) of Borrower, when taken as a whole, or of Borrower and its Subsidiaries, taken as a whole; (b) a material impairment of the prospect of repayment of any portion of the Obligations, or (c) a material adverse effect on the Collateral.

“Material Agreement” is any license, agreement or other contractual arrangement with a Person or Governmental Authority whereby Borrower or any of its Subsidiaries is reasonably likely to be required to transfer, either in-kind or in cash, prior to the Maturity Date, assets or property valued (book or market) at more than Five Hundred Thousand Dollars ($500,000.00) in the aggregate.

“Maturity Date” is August 2, 2027.

“Medicare Account” is any “zero balance” deposit account maintained by Borrower, solely for the purpose of receiving payments owed to the Borrower in the framework of Medicare, Medicaid or any other Governmental Authority healthcare program and identified to Collateral Agent on the applicable Perfection Certificate or otherwise by written notice.

“MLI” means the Multilateral Convention to Implement Tax Treaty Related Measures to Prevent BEPS.

“Non-Cooperative Jurisdiction” means a tax haven country, a low-tax jurisdiction or a non-cooperative jurisdiction, and any other State or jurisdiction within the meaning of Article 307, §1/2, of the Belgian Income Tax Code 1992 or any successor provision.

“Non-Resident Saver” means any Person not resident in Belgium for tax purposes and which does not use its share in the Loan to exercise a professional activity in Belgium pursuant to Article 105, 5° of the Royal Decree of 27 August 1993 implementing the Belgian Income Tax Code 1992.

“Notice of Conversion” has the meaning as given in Section 2.10.

“Oncotype DX GPS Acquisition” is the acquisition by Borrower of all assets of Exact Sciences Corporation related to the product Oncotype DX GPS in accordance with the Acquisition Documents.

“Obligations” are all of Borrower’s obligations to pay when due any debts, principal, interest, Lenders’ Expenses, the Prepayment Fee, the Final Fee, and other amounts Borrower owes the Lenders now or later, in connection with, related to, following, or arising from, out of or under, this Agreement or, the other Loan Documents, and including interest accruing after Insolvency Proceedings begin (whether or not allowed) and debts, liabilities, or obligations of Borrower assigned to the Lenders and/or Collateral Agent, and the performance of Borrower’s duties under the Loan Documents..

“OFAC” is the U.S. Department of Treasury Office of Foreign Assets Control.

“OFAC Lists” are, collectively, the Specially Designated Nationals and Blocked Persons List maintained by OFAC pursuant to Executive Order No. 13224, 66 Fed. Reg. 49079 (Sept. 25, 2001) and/or any other list of terrorists or other restricted Persons maintained pursuant to any of the rules and regulations of OFAC or pursuant to any other applicable Executive Orders.

“Operating Documents” are, for any Person, such Person’s formation documents, as certified by the Secretary of State (or equivalent agency) of such Person’s jurisdiction of organization on a date that is no earlier than thirty (30) days prior to the Effective Date, and, (a) if such Person is a corporation, its bylaws in current form, (b) if such Person is a limited liability company, its limited liability company agreement (or similar agreement), and (c) if such Person is a partnership, its partnership agreement (or similar agreement), each of the foregoing with all current amendments or modifications thereto.

“Patents” means all patents, patent applications and like protections including without limitation improvements, divisions, continuations, renewals, reissues, re-examination certificates, utility models, extensions and continuations-in-part of the same.

“Payment Date” is the first (1st) calendar day of each calendar month, commencing on September 1, 2022. “Permitted Indebtedness” is:

(a) Borrower’s Indebtedness to the Lenders and Collateral Agent under this Agreement and the other Loan Documents;

(b) Indebtedness existing on the Effective Date and disclosed on the Perfection Certificate(s); provided, however, Kreos Discretionary Convertible Debt shall cease to be Permitted Indebtedness commencing the date that is thirty (30) days immediately after the Funding Date of the Term A Loan;

(d) unsecured Indebtedness to trade creditors and Indebtedness in connection with credit cards incurred in the ordinary course of business;

(e) Indebtedness consisting of capitalized lease obligations and purchase money Indebtedness, in each case incurred by Borrower or any of its Subsidiaries to finance the acquisition, repair, improvement or construction of fixed or capital assets of such Person, provided that (i) the aggregate outstanding principal amount of all such Indebtedness does not exceed Two Million Dollars ($2,000,000.00) at any time and (ii) the principal amount of such Indebtedness does not exceed the lower of the cost or fair market value of the property so acquired or built or of such repairs or improvements financed with such Indebtedness (each measured at the time of such acquisition, repair, improvement or construction is made);

(f) Indebtedness incurred as a result of endorsing of checks and other negotiable instruments for deposit or collection received in the ordinary course of Borrower’s business;

(g) (i) Indebtedness of Borrower to any Borrower or (ii) Subsidiary to a Borrower or another Subsidiary so long as such Indebtedness is pursuant to a Permitted Investment;

(h) Indebtedness in respect of performance bonds, bid bonds, appeal bonds, surety bonds and completion guarantees and similar obligations not in connection with money borrowed, in each case provided in the ordinary course of business, including those incurred to secure health, safety and environmental obligations in the ordinary course of business; provided, however, the aggregate amount of such Indebtedness at any given time does not exceed Two Hundred Fifty Thousand Dollars ($250,000.00);

(i) obligations (contingent or otherwise) of Borrower or any Subsidiary existing or arising under any Swap Contract entered into (i) to hedge or mitigate risks to which Borrower or any Subsidiary has actual exposure and not for speculative purpose or (ii) in order to effectively cap, collar or exchange interest rates (from fixed to floating rates, from one floating rate to another floating rate or otherwise) with respect to any interest-bearing liability or investment of Borrower or any Subsidiary, in each case, in the ordinary course of business; provided, however, the aggregate amount of such Indebtedness at any given time does not exceed Two Hundred Fifty Thousand Dollars ($250,000.00);

(j) Guarantees by Borrower of Indebtedness otherwise permitted hereunder of any Subsidiary and by any Subsidiary of Indebtedness otherwise permitted hereunder of Borrower or any other Subsidiary;

(k) Indebtedness of Borrower or any Subsidiary as an account party in respect of commercial letters of credit; provided, however, the aggregate amount of such Indebtedness at any given time does not exceed Seven Hundred Fifty Thousand Dollars Dollars ($750,000.00);

(l) extensions, refinancings, modifications, amendments and restatements of any items of Permitted Indebtedness (a) through (k) above, provided that the principal amount thereof is not increased or the terms thereof are not modified to impose materially more burdensome terms upon Borrower, or its Subsidiary, as the case may be; and

(m) other unsecured Indebtedness in an aggregate principal amount not exceeding $500,000 at any time outstanding.

“Permitted Investments” are:

(a) Investments disclosed on the Perfection Certificate(s) and existing on the Effective Date;

(b) Investments consisting of cash and Cash Equivalents, and (ii) any Investments permitted by Borrower’s investment policy, as amended from time to time, provided that such investment policy (and any such amendment thereto) has been approved in writing by Collateral Agent;

(c) Investments consisting of the endorsement of negotiable instruments for deposit or collection or similar transactions in the ordinary course of Borrower or its Subsidiaries;

(d) Investments consisting of Deposit Accounts in which Collateral Agent has a perfected security interest;

(e) Investments in connection with Transfers permitted by Section 7.1;

(f) Investments consisting of (i) travel advances and employee relocation loans and other employee loans and advances in the ordinary course of business, and (ii) loans to employees, officers or directors relating to the purchase of equity securities of Borrower or its Subsidiaries pursuant to employee stock purchase plans or agreements approved by Borrower’s board of directors, not to exceed Five Hundred Thousand Dollars ($500,000.00) in the aggregate for (i) and (ii) in any fiscal year;

(g) Investments (including debt obligations) received in connection with the bankruptcy or reorganization of customers or suppliers and in settlement of delinquent obligations of, and other disputes with, customers or suppliers arising in the ordinary course of business;

(h) Investments consisting of notes receivable of, or prepaid royalties and other credit extensions, to customers and suppliers who are not Affiliates, in the ordinary course of business; provided that this paragraph (h) shall not apply to Investments of Borrower in any Subsidiary; and

(i) non-cash Investments in joint ventures or strategic alliances in the ordinary course of Borrower’s business consisting of the non-exclusive licensing of technology, the development of technology or the providing of technical support.

“Permitted Licenses” are (A) licenses of over-the-counter software that is commercially available to the public, (B) licenses of Intellectual Property that is not materially useful to the business of Borrower or of any of its Subsidiaries, and (C) non-exclusive and exclusive licenses for the use of the Intellectual Property of Borrower or any of its Subsidiaries entered into in the ordinary course of business, provided, that, with respect to each such license described in clause (C), (i) the license constitutes an arms-length transaction, the terms of which, on their face, do not provide for a sale or assignment of any Intellectual Property and do not restrict the ability of Borrower or any of its Subsidiaries, as applicable, to pledge, grant a security interest in or lien on, or assign or otherwise Transfer any Intellectual Property; (ii) in the case of any exclusive license, (x) no Event of Default has occurred or is continuing at the time of such license; (y) Borrower delivers ten (10) days’ prior written notice and a brief summary of the terms of the proposed license to Collateral Agent and the Lenders and delivers to Collateral Agent and the Lenders copies of the final executed licensing documents in connection with the exclusive license promptly upon consummation thereof, and (z) any such license could not result in a legal transfer of title of the licensed property but may be exclusive in respects other than territory and may be exclusive as to territory only as to discrete geographical areas outside of the United State and Europe; and (iii) all upfront payments, royalties, milestone payments or other proceeds arising from the licensing agreement that are payable to Borrower or any of its Subsidiaries are paid to a Deposit Account that is governed by a Control Agreement.

“Permitted Liens” are:

(a) Liens existing on the Effective Date and disclosed on the Perfection Certificates or arising under this Agreement and the other Loan Documents;

(b) Liens for taxes, fees, assessments or other government charges or levies, either (i) not due and payable or (ii) being contested in good faith and for which Borrower maintains adequate reserves on its books, provided that no notice of any such Lien has been filed or recorded under the Internal Revenue Code of 1986, as amended, and the Treasury Regulations adopted thereunder;

(c) liens securing Indebtedness permitted under clause (e) of the definition of “Permitted Indebtedness,” provided that (i) such liens exist prior to incurring such Indebtedness of, or attach substantially simultaneous with, or within forty-five (45) days after incurring such Indebtedness and (ii) such liens do not extend to any property of Borrower other than the property (and proceeds thereof) acquired, leased or built, or the improvements or repairs, financed by such Indebtedness;

(d) Liens of carriers, warehousemen, suppliers, or other Persons that are possessory in nature arising in the ordinary course of business so long as such Liens attach only to Inventory, securing liabilities in the aggregate amount not to exceed Two Hundred Fifty Thousand Dollars ($250,000.00), and which are not delinquent or remain payable without penalty or which are being contested in good faith and by appropriate proceedings which proceedings have the effect of preventing the forfeiture or sale of the property subject thereto;

(e) Liens to secure payment of workers’ compensation, employment insurance, old age pensions, social security and other like obligations incurred in the ordinary course of business (other than Liens imposed by ERISA);

(f) Liens incurred in the extension, renewal or refinancing of the indebtedness secured by Liens described in (a) through (c), but any extension, renewal or replacement Lien must be limited to the property encumbered by the existing Lien and the principal amount of the indebtedness may not increase;

(g) leases or subleases of real property granted in the ordinary course of Borrower’s business (or, if referring to another Person, in the ordinary course of such Person’s business), and leases, subleases, non¬exclusive licenses or sublicenses of personal property (other than Intellectual Property) granted in the ordinary course of Borrower’s business (or, if referring to another Person, in the ordinary course of such Person’s business), if the leases, subleases, licenses and sublicenses do not prohibit granting Collateral Agent or any Lender a security interest therein;

(h) banker’s liens, rights of setoff and Liens in favor of financial institutions incurred in the ordinary course of business arising in connection with Borrower’s deposit accounts or securities accounts held at such institutions solely to secure payment of fees and similar costs and expenses and provided such accounts are maintained in compliance with Section 6.6 hereof;

(i) Liens arising from judgments, decrees or attachments in circumstances not constituting an Event of Default under Section 8.4 or 8.7;

(j) Permitted Licenses; and

(k) Liens securing Indebtedness and other obligations in an aggregate amount not exceeding $100,000 at any time outstanding.

“Person” is any individual, sole proprietorship, partnership, limited liability company, joint venture, company, trust, unincorporated organization, association, corporation, institution, public benefit corporation, firm, joint stock company, estate, entity or government agency.

“PIK Rate” is 2.25%.

“Prepayment Fee” is, with respect to any Term Loan subject to prepayment prior to the Maturity Date, whether by mandatory or voluntary prepayment, acceleration or otherwise, an additional fee payable to the Lenders in amount equal to:

(i) for a prepayment made on or after the Effective Date and through and including the date which is the first anniversary of the Effective Date, three percent (3.00%) of the principal amount of the Term Loans prepaid; provided, however, a prepayment may only be made on or prior to the first anniversary of the Effective Date pursuant to Section 2.2(c) and no voluntary prepayment may be during such period;

(ii) for a prepayment made after the date which is the first anniversary of the Effective Date and through and including the date which is the second anniversary of the Effective Date, two percent (2.00%) of the principal amount of the Term Loans prepaid;

(iii) for a prepayment made after the date which is the second anniversary of the Effective Date through and including the date which is the third anniversary of the Effective Date, one percent (1.00%) of the principal amount of the Term Loan prepaid; and

(iv) for a prepayment made after the date which is the third anniversary of the Effective Date and prior to the Maturity Date, zero percent (0.00%) of the principal amount of the Term Loan prepaid.

Prime Rate” is the Prime Rate published in The Wall Street Journal (or any successor publication if The Wall Street Journal is no longer published) in the “Money Rates” section (or such successor section).

“Property” means any interest in any kind of property or asset, whether real, personal or mixed, and whether tangible or intangible.

“Pro Rata Share” is, as of any date of determination, with respect to each Lender, a percentage (expressed as a decimal, rounded to the ninth decimal place) determined by dividing the outstanding principal amount of the Term Loan held by such Lender by the aggregate outstanding principal amount of the Term Loan.

“Qualifying Lender” means any Person which is:

(a) a professional investor within the meaning of Article 105, 3° of the Royal Decree of 27 August 1993 implementing the Belgian Income Tax Code 1992, which is a company resident for tax purposes in Belgium or which is acting through a Facility Office established in Belgium with which the Loan is effectively connected, other than mentioned in (b);

(b) a credit institution as referred to Article 105, 1°, a) of the Royal Decree of 27 August 1993 implementing the Belgian Income Tax Code 1992, which is a company resident for tax purposes in Belgium or which is acting through a Facility Office established in Belgium with which the relevant Loan under a Loan Document is effectively connected;

(c) a credit institution within the meaning of Article 107, §2, 5, a), second dash of the Royal Decree of 27 August 1993 implementing the Belgian Income Tax Code 1992, that is acting through its head office and is resident for tax purposes in a country with which Belgium has entered into a double taxation agreement that is in force (irrespective of whether or not the double taxation agreement makes provision for exemption from tax imposed by Belgium) or in a country which is a member state of the European Economic Area;

(d) a credit institution within the meaning of Article 107, §2, 5, a), second dash of the Royal Decree of 27 August 1993 implementing the Belgian Income Tax Code 1992, that is acting through a Facility Office which (i) itself qualifies as a credit institution within the meaning of the aforementioned article 107, §2, 5, a) second dash and (ii) is located in a country with which Belgium has entered into a double taxation agreement that is in force (irrespective of whether or not the double taxation agreement makes provision for exemption from tax imposed by Belgium) or in a country which is a member state of the European Economic Area;

(e) a Non-Resident Saver; or

(f) a Treaty Lender.

“Registered Organization” is any “registered organization” as defined in the Code with such additions to such term as may hereafter be made under the Code.

“Registration” means any registration, authorization, approval, license, permit, clearance, certificate, and exemption issued or allowed by the FDA or state pharmacy licensing authorities (including, without limitation, new drug applications, abbreviated new drug applications, biologics license applications, investigational new drug applications, over-the-counter drug monograph, device pre-market approval applications, device pre-market notifications, investigational device exemptions, product recertifications, manufacturing approvals, registrations and authorizations, CE Marks, pricing and reimbursement approvals, labeling approvals or their foreign equivalent, controlled substance registrations, and wholesale distributor permits).

“Regulatory Action” means an administrative, regulatory, or judicial enforcement action, proceeding, investigation or inspection, FDA Form 483 notice of inspectional observation, warning letter, untitled letter, other notice of violation letter, recall, seizure, Section 305 notice or other similar written communication, injunction or consent decree, issued by the FDA or a federal or state court.

“Related Persons” means, with respect to any Person, each Affiliate of such Person and each director, officer, employee, agent, trustee, representative, attorney, accountant and each insurance, environmental, legal, financial and other advisor and other consultants and agents of or to such Person or any of its Affiliates.

“Required Lenders” means (i) for so long as all of the Persons that are Lenders on the Effective Date (each an “Original Lender”) have not assigned or transferred any of their interests in the Term Loan, Lenders holding one hundred percent (100.00%) of the aggregate outstanding principal balance of the Term Loan, or (ii) at any time from and after any Original Lender has assigned or transferred any interest in its Term Loan, Lenders holding at least fifty one percent (51.00%) of the aggregate outstanding principal balance of the Term Loan.

“Requirement of Law” is as to any Person, the organizational or governing documents of such Person, and any law (statutory or common), treaty, rule or regulation or determination of an arbitrator or a court or other Governmental Authority, in each case applicable to or binding upon such Person or any of its property or to which such Person or any of its property is subject.

“Responsible Officer” is any of the President, Chief Executive Officer, or Chief Financial Officer of Borrower acting alone.

“Secured Promissory Note” is defined in Section 2.6.

“Secured Promissory Note Record” is a record maintained by each Lender with respect to the outstanding Obligations owed by Borrower to Lender and credits made thereto.

“Securities Account” is any “securities account” as defined in the Code with such additions to such term as may hereafter be made under the Code.

Shares” is one hundred percent (100%) of the issued and outstanding capital stock, membership units or other securities owned or held of record by Borrower or Borrower’s Subsidiary, in any Subsidiary; provided that, in the event Borrower, demonstrates to Collateral Agent’s reasonable satisfaction, that a pledge of more than sixty five percent (65%) of the Shares of such Subsidiary which is a Foreign Subsidiary, creates a present and existing adverse tax consequence to Borrower under the U.S. Internal Revenue Code, “Shares” shall mean sixty-five percent (65%) of the issued and outstanding capital stock, membership units or other securities owned or held of record by Borrower or its Subsidiary in such Foreign Subsidiary.

“Solvent” is, with respect to any Person: the fair salable value of such Person’s consolidated assets (including goodwill minus disposition costs) exceeds the fair value of such Person’s liabilities; such Person is not left with unreasonably small capital after the transactions in this Agreement; and such Person is able to pay its debts (including trade debts) as they mature in the ordinary course (without taking into account any forbearance and extensions related thereto).

“Subordinated Debt” is indebtedness incurred by Borrower or any of its Subsidiaries subordinated to all Indebtedness of Borrower and/or its Subsidiaries to the Lenders (pursuant to a subordination, intercreditor, or other similar agreement in form and substance satisfactory to Collateral Agent and the Lenders entered into between Collateral Agent, Borrower, and/or any of its Subsidiaries, and the other creditor), on terms acceptable to Collateral Agent and the Lenders.

“Subsidiary” is, with respect to any Person, any Person of which more than fifty percent (50.00%) of the voting stock or other equity interests (in the case of Persons other than corporations) is owned or controlled, directly or indirectly, by such Person or through one or more intermediaries. Unless otherwise specified, references herein to a Subsidiary means a Subsidiary of Borrower.

“Swap Contract” means (a) any and all rate swap transactions, basis swaps, credit derivative transactions, forward rate transactions, commodity swaps, commodity options, forward commodity contracts, equity or equity index swaps or options, bond or bond price or bond index swaps or options or forward bond or forward bond price or forward bond index transactions, interest rate options, forward foreign exchange transactions, cap transactions, floor transactions, collar transactions, currency swap transactions, cross-currency rate swap transactions, currency options, spot contracts or any other similar transactions or any combination of any of the foregoing (including any options to enter into any of the foregoing), whether or not any such transaction is governed by or subject to any master agreement, and (b) any and all transactions of any kind, and the related confirmations, that are subject to the terms and conditions of, or governed by, any form of master agreement published by the International Swaps and Derivatives Association, Inc., any International Foreign Exchange Master Agreement or any other master agreement (any such master agreement, together with any related schedules, a “Master Agreement”), including any such obligations or liabilities under any Master Agreement.

“Term Loan Commitment” is, for any Lender, the obligation of such Lender to make the Term Loan, up to the principal amount shown on Schedule 1.1. “TermLoan Commitments” means the aggregate amount of such commitments of all Lenders.

“Term B Draw Period” is the period commencing on the later of (i) the first date on which Borrower achieves the Term B Milestone and (ii) January 1, 2024 and ending the earlier of (i) June 30, 2024 and (ii) the occurrence of an Event of Default (unless such Event of Default is waived by Collateral Agent and Lenders for the purposes of the continuation of the Term B Draw Period).

“Term B Milestone” is (i) the Funding of the Term A Loan and (ii) the achievement by Borrower and its Subsidiaries of aggregate revenues from the sales of Oncotype DX GPS products, determined in accordance with IFRS, for the fiscal year 2023 of not less than $24,900,000.00.

“Term C Draw Period” is the period commencing on the later of (i) the first date on which Borrower achieves the Term C Milestone and (ii) January 1, 2025 and ending the earlier of (i) June 30, 2025 and (ii) the occurrence of an Event of Default (unless such Event of Default is waived by Collateral Agent and Lenders for the purposes of the continuation of the Term C Draw Period).

“Term C Milestone” is the (i) the Funding of the Term A Loan and (ii) the achievement by Borrower and its Subsidiaries of aggregate revenues from the sales of Oncotype DX GPS products, determined in accordance with IFRS, for the fiscal year 2024 of not less than $30,700,000.00.

“Trademarks” means any trademark and servicemark rights, whether registered or not, applications to register and registrations of the same and like protections, and the entire goodwill of the business of Borrower and each of its Subsidiaries connected with and symbolized by such trademarks.

“Trading Days” means any days during the course of which the principal securities exchange on which the Parent Equity is listed or admitted to trading is open for the exchange of securities.

“Transfer” is defined in Section 7.1.

“Treaty Lender” means any Person which:

(a) is treated for the purposes of a relevant double taxation agreement as a resident of a jurisdiction having a double taxation agreement with Belgium which makes provision for full or partial exemption from withholding tax imposed by Belgium on interest; and

(b) does not carry on a business in Belgium through a permanent establishment with which the Lender’s participation in a Loan is effectively connected.

“TTM Revenue” means trailing twelve (12) months revenue, determined in accordance with IFRS, as of any date of determination.

[Balance of Page Intentionally Left Blank]

IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed as of the Effective Date.

BORROWER:
MDXHEALTH SA
By:		/s/ Michael McGarrity
Name:		Michael McGarrity
Title:		Authorized representative
BORROWER:
MDXHEALTH, INC.
By:		/s/ Michael McGarrity
Name:		Michael McGarrity
Title:		Director and CEO
COLLATERAL AGENT AND LENDER:
INNOVATUS LIFE SCIENCES LENDING FUND I, LP
By: Innovatus Life Sciences GP, LP
Its: General Partner
	By:	/s/ Andrew Ryan
	Name:	Andrew Ryan
	Title:	Authorized representative

[Signature Page to Loan and Security Agreement]

Schedule 1.1

Lenders and Commitments

Term A Loan

Lender	Term Loan A Commitment		Commitment Percentage
INNOVATUS LIFE SCIENCES LENDING FUND I, LP	$	35,000,000	100.00%
TOTAL	$	35,000,000	100.00%

Term B Loan

Lender	Term Loan B Commitment		Commitment Percentage
INNOVATUS LIFE SCIENCES LENDING FUND I, LP	$	20,000,000	100.00%
TOTAL	$	20,000,000	100.00%

Term C Loan

Lender	Term Loan B Commitment		Commitment Percentage
INNOVATUS LIFE SCIENCES LENDING FUND I, LP	$	15,000,000	100.00%
TOTAL	$	15,000,000	100.00%

Schedule 2

Notice of Conversion

To:	MDxHealth SA
	Rue d’Abhooz 31
	4040 Herstal
	Belgium
From:	[Lenders]

[Place/Date]

Loan and Security Agreement – Noticeof Conversion

Dear Sirs,

The present letter (the “Notice of Conversion”) is sent on behalf of [Lender], with registered office at [ ], and registered with [relevant company registration] under number [relevant number] [and] / [Lender], with registered office at [ ], and registered with [relevant company registration] under number [relevant number].

We refer to the Loan and Security Agreement dated [ ] 2022, as may be amended from time to time (the “Agreement”), between [Lenders] as Lenders, and MDxHealth SA and MDxHealth, Inc. as Borrower. Capitalized terms used in this Notice of Conversion but not otherwise defined herein shall have the meaning as ascribed to them in the Agreement.

In full knowledge of the Parent’s articles of association, the Lenders hereby irrevocably confirm to the Borrower that:

1.	they exercise the Conversion To Equity right as pursuant to Section 2.10 of the Agreement for an amount<br>of USD [●] (the “Conversion Amount”) against the issuance by Parent of new ordinary shares of Parent, to be delivered<br>to the Lenders in the form of [●] ADSs of Parent;
2.	they shall contribute in kind an ADS Payable, which is due by Parent for an amount equal to the Conversion<br>Amount to the share capital of Parent against the issuance by Parent of new ordinary shares of Parent, to be delivered to the Lenders<br>in the form of [●] ADSs of Parent;
---	---
3.	the relevant ADSs of Parent to be delivered to the Lenders shall need to be delivered to [deliverydetails / account details to be included]; and
---	---
4.	they authorize the Parent to take the actions and make the declarations as are necessary to notary public<br>in order to confirm the aforementioned consideration in kind against the issuance of new ordinary shares of the Parent, to be delivered<br>to the Lenders in the form of ADSs of Parent.
---	---

Yours faithfully,

On behalf of [Lenders]
Name:

EXHIBIT A

Description of Collateral

The Collateral consists of all of Borrower’s right, title and interest in and to the following property:

All goods, Accounts (including health-care receivables), Equipment, Inventory, contract rights or rights to payment of money, leases, license agreements, franchise agreements, General Intangibles (including Intellectual Property), commercial tort claims, documents, instruments (including any promissory notes), chattel paper (whether tangible or electronic), cash, deposit accounts and other Collateral Accounts, all certificates of deposit, fixtures, letters of credit rights (whether or not the letter of credit is evidenced by a writing), securities, and all other investment property, supporting obligations, and financial assets, whether now owned or hereafter acquired, wherever located; and

All Borrower’s Books relating to the foregoing, and any and all claims, rights and interests in any of the above and all substitutions for, additions, attachments, accessories, accessions and improvements to and replacements, products, proceeds and insurance proceeds of any or all of the foregoing.

Notwithstanding the foregoing, Collateral does not include:

(i) more than 65% of the total combined voting power of all classes of stock entitled to vote the shares of capital stock (the “Shares”) of any Foreign Subsidiary, if Borrower demonstrates to Collateral Agent’s reasonable satisfaction that a pledge of more than sixty five percent (65%) of the Shares of such Subsidiary creates a present and existing adverse tax consequence to Borrower under the U.S. Internal Revenue Code;

(ii) any leases, licenses, permits or agreements to the extent that, and so long as, a grant of a security interest therein, or in the property or assets that secure the underlying obligations with respect thereto (a) is prohibited by applicable law other than to the extent such prohibition is rendered ineffective under the UCC or other applicable law notwithstanding such prohibition or (b) would violate or invalidate such lease, license, permit or agreement with respect to any Intellectual Property, or create a right of termination in favor of, or require the consent of, any other party thereto, other than the proceeds thereof, and only for so long as such limitation on such pledge or security interest is subject to the limitations described above;

(iii) any motor vehicles and other assets subject to certificates of title and letter of credit rights, to the extent a Lien therein cannot be perfected by the filing of a UCC financing statement;

(iv) any “intent-to-use” application for registration of a trademark or service mark filed pursuant to Section 1(b) of the Lanham Act, 15 U.S.C. § 1051, prior to the filing of a “Statement of Use” pursuant to Section 1(d) of the Lanham Act or an “Amendment to Allege Use” pursuant to Section 1(c) of the Lanham Act with respect thereto, solely to the extent, if any, that, and solely during the period, if any, in which, the grant of a security interest therein would impair the validity or enforceability of any registration that issues from such intent-to-use application under applicable law;

(iv) deposit accounts exclusively used for payroll, payroll taxes and other employee wage and benefit payments to or for the benefit of Borrower’s, or any of its Subsidiaries’, employees;

(v) the Medicare Accounts; and

(vi) any receivable, at any time, owed to the Borrower in the framework of Medicare, Medicaid or any other Governmental Authority healthcare program, in which Borrower is prohibited from granting a security interest under applicable law other than to the extent such prohibition is rendered ineffective under the UCC or other applicable law notwithstanding such prohibition; provided, however, any proceeds of such receivable shall, to the fullest extent permissible under applicable law, be part of Collateral.

EXHIBIT B-1

Loan Payment Request Form

Fax To:	Date:_________
LOAN PAYMENT:
---	---
MDXHEALTH SA; MDXHEALTH, INC.
From Account #:	To Account #

Principal	and/or Interest
Authorized Signature:	Phone Number:
Print Name/Title:

All values are in US Dollars.

LOAN ADVICE
Complete Outgoing Wire Request section below if all or a portion of the funds from this loan advance are for an outgoing wire.
From Account #:	To Account #
		(Deposit Account #)
Amount of Advance
All Borrower’s representations and warranties in the Loan and Security Agreement are true, correct and complete in all material respects on the date of the request for an advance; provided, however, that such materiality qualifier shall not be applicable to any representations and warranties that already are qualified or modified by materiality in the text thereof; and provided, further that those representations and warranties expressly referring to a specific date shall be true, accurate and complete in all material respects as of such date:
Authorized Signature:	Phone Number:
Print Name/Title:

All values are in US Dollars.

OUTGOING WIRE REQUEST:
Complete only if all or a portion of funds from the loan advance are for an outgoing wire.
Beneficiary Name:	Amount of Wire: $
Beneficiary Bank:	Account Number:
City and State:
Beneficiary Bank Transit (ABA) #	Beneficiary Bank Code (Swift, Sort, Chip, etc.):
---	---
****	(For International Wire Only)
Intermediary Bank:	Transit (ABA) #:
---	---
For Further Credit to:
Special Instruction:
By signing below, I (we) acknowledge and agree that my (our) funds transfer request shall be processed in accordance with and subject to the terms and conditions set forth in the agreements(s) covering funds transfer service(s), which agreements(s) were previously received and executed by me (us).
Authorized Signature:	2^nd^Signature (if required):
---	---
Print Name/ Title:	Print Name/ Title:
Telephone #:	Telephone #:

EXHIBIT B-2

Form of Disbursement Letter

[see attached]

DISBURSEMENT LETTER

August 2, 2022

The undersigned, being the duly elected and acting Chief Executive Officer of MDXHEALTH SA, a Belgian corporation (“Borrower”), does hereby certify (on behalf of Borrower and not in my personal capacity) to INNOVATUS LIFE SCIENCES LENDING FUND I, LP (“Innovatus” and “Lender”), as collateral agent (the “Collateral Agent”) in connection with that certain Loan and Security Agreement dated as of August 2, 2022, by and among Borrower, Collateral Agent and the Lenders from time to time party thereto (the “Loan Agreement”; with other capitalized terms used below having the meanings ascribed thereto in the Loan Agreement) that:

The representations and warranties made by Borrower in Section 5 of the Loan Agreement and in the other Loan Documents are true and correct in all material respects as of the date hereof.
No event or condition has occurred that would constitute an Event of Default under the Loan Agreement or any other Loan Document.
All conditions referred to in Section 3 of the Loan Agreement to the making of the Loan to be made on or about the date hereof have been satisfied or waived by Collateral Agent.
No Material Adverse Change has occurred.
The undersigned is a Responsible Officer.

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The proceeds of the Term A Loan shall be disbursed as follows:

[***]

The Term A Loan shall amortize in accordance with the Loan Interest Rate And Payment Of Principal schedule attached as Annex Y (as amended or restated from time to time) to the Loan Agreement.
The aggregate net proceeds of the Term A Loan shall be transferred to the Designated Deposit Account as follows:

[***]

[Balance of Page Intentionally Left Blank]

Dated as of the date first set forth above.
BORROWER:
MDXHEALTH SA, on behalf of all Borrowers
By
Name:
Title:
COLLATERAL AGENT AND LENDER:
INNOVATUS LIFE SCIENCES LENDING FUND I, LP
By: Innovatus Life Sciences GP, LP
Its: General Partner
	By
	Name:
	Title:

EXHIBIT C

Compliance Certificate

TO:	INNOVATUS LIFE SCIENCES LENDING FUND I,<br>LP, as Collateral Agent and Lender
FROM:	MDXHEALTH SA, as Borrower

The undersigned authorized officer (“Officer”) of MDXHEALTH SA (“Borrower”), hereby certifies (on behalf of Borrower and not in my personal capacity) that in accordance with the terms and conditions of the Loan and Security Agreement dated as of August [_], 2022, by and among Borrower, Collateral Agent, and the Lenders from time to time party thereto (the “Loan Agreement;” capitalized terms used but not otherwise defined herein shall have the meanings given them in the Loan Agreement),

(a) Borrower is in complete compliance with the financial covenants set forth in Section 6.12 of the Loan Agreement for the period ending with all required covenants except as noted below.

(b) There are no Defaults or Events of Default, except as noted below.

(c) Except as noted below, all representations and warranties of Borrower stated in the Loan Documents are true and correct in all material respects on this date and for the period described in (a), above; provided, however, that such materiality qualifier shall not be applicable to any representations and warranties that already are qualified or modified by materiality in the text thereof; and provided, further that those representations and warranties expressly referring to a specific date shall be true, accurate and complete in all material respects as of such date.

(d) Borrower, and each of Borrower’s Subsidiaries, has timely filed all required tax returns and reports, Borrower, and each of Borrower’s Subsidiaries, has timely paid all foreign, federal, state, and local taxes, assessments, deposits and contributions owed by Borrower, or Subsidiary, except as otherwise permitted pursuant to the terms of Section 5.8 of the Loan Agreement;

(e) No Liens have been levied or claims made against Borrower or any of its Subsidiaries relating to unpaid employee payroll or benefits of which Borrower has not previously provided written notification to Collateral Agent and the Lenders.

Attached are the required documents, if any, supporting our certification(s). The Officer, on behalf of Borrower, further certifies that the attached financial statements are prepared in accordance with IFRS and are consistently applied from one period to the next except as explained in an accompanying letter or footnotes and except, in the case of unaudited financial statements, for the absence of footnotes and subject to year-end audit adjustments as to the interim financial statements.

Please indicate compliance status since thelast Compliance Certificate by circling Yes, No, or N/A under “Complies” column.

	Reporting Covenant	Requirement		Actual	Complies
1)	Financial statements	Quarterly within 45 days			Yes	No	N/A
2)	Annual (CPA Audited) statements	Within 120 days after FYE			Yes	No	N/A
3)	Annual Financial Projections/Budget (prepared on a monthly basis)	Annually (within earlier 10 days of approval or 45 days of FYE), and when revised (no later than 7 days of approval)			Yes	No	N/A
4)	6-K, 8-K, 10-K, 20-F and 10-Q Filings	If applicable, within 5 days of filing			Yes	No	N/A
5)	Month-end account statements	Monthly within 30 days			Yes	No	N/A
6)	Compliance Certificate	Quarterly within 30 days			Yes	No	N/A
7)	IP Report	When required			Yes	No	N/A
8)	Total amount of Borrower’s cash and cash equivalents at the last day of the measurement period		$	________	Yes	No	N/A
9)	Total amount of Borrower’s Subsidiaries’ cash and cash equivalents at the last day of the measurement period		$	________	Yes	No	N/A
10)	Loan confirmation submitted to the fund administrator for Innovatus Life Sciences Lending Fund I, LP (see Exhibit C-2 to the Loan Agreement)	Quarterly within 45 days			Yes	No	N/A

Negative Covenant Compliance

****	Negative Covenant	Complies
1)	Dispositions (§ 7.1)	Yes	No	N/A
2)	Changes in Business, Management, Ownership, or Business Locations (§ 7.2)	Yes	No	N/A
3)	Mergers or Acquisitions (§ 7.3)	Yes	No	N/A
4)	Indebtedness (§ 7.4)	Yes	No	N/A
5)	Encumbrance (§ 7.5)	Yes	No	N/A
6)	Maintenance of Collateral Accounts (§ 7.6)	Yes	No	N/A
7)	Restricted Payments (§ 7.7)	Yes	No	N/A
8)	Investments (§ 7.8)	Yes	No	N/A
9)	Transactions with Affiliates (§ 7.9)	Yes	No	N/A
10)	Subordinated Debt (§ 7.10)	Yes	No	N/A
11)	Compliance (§ 7.11)	Yes	No	N/A
12)	Compliance with Anti Terrorism Laws (§ 7.12)	Yes	No	N/A
13)	Material Agreements (§ 7.13)	Yes	No	N/A

Please attach supporting documentation and calculations for the below financial covenants.

	Covenant	Requirement	Actual		Complies
1)	Minimum TTM Revenue	Set forth in Section 6.12	$	_______	Yes	No	N/A
2)	Minimum Cash Balance	Set forth in Section 6.13	$	_______	Yes	No	N/A

Deposit and Securities Accounts

(Please list all accounts; attach separate sheet if additional space needed)

	New Account?		Account Control Agreement in place?
1)	Yes	No	Yes	No
2)	Yes	No	Yes	No
3)	Yes	No	Yes	No
4)	Yes	No	Yes	No

Other Matters

1)	Have there been any changes in any Key Person since the last Compliance Certificate?	Yes	No
2)	Have there been any transfers/sales/disposals/retirement of Collateral or IP prohibited by the Loan Agreement?	Yes	No
3)	Have there been any new or pending claims or causes of action against Borrower that involve more than One Hundred Thousand Dollars ($100,000.00)?	Yes	No
4)	Have there been any amendments of or other changes to the capitalization table of Borrower and to the Operating Documents of Borrower or any of its Subsidiaries? If yes, provide copies of any such amendments or changes with this Compliance Certificate.	Yes	No
5)	Has Borrower or any Subsidiary entered into or amended any Material Agreement? If yes, please explain and provide a copy of the Material Agreement(s) and/or amendment(s).	Yes	No
6)	Has Borrower provided the Collateral Agent with all notices required to be delivered under Sections 6.2(a) and 6.2(b) of the Loan Agreement?	Yes	No
7)	Have there been any material updates to the contents of the Perfection Certificate last delivered? If yes, please explain.	Yes	No
8)	Since the last Compliance Certificate, do you anticipate any impending product shortages or supply chain disruptions? If yes, please explain.	Yes	No
9)	Are there major components from suppliers that are single sourced? If yes, please explain.	Yes	No
10)	Does the Business Continuity Plan address potential business interruptions and provide a plan to resume business operations?	Yes	No
11)	Have there been any changes to insurance policies providing coverage for business interruption since the last Compliance Certificate? If yes, please explain.	Yes	No

Exceptions

Please explain any exceptions with respect to the certification above: (If no exceptions exist, state “No exceptions.” Attach separate sheet if additional space needed.)

MDXHEALTH SA, on behalf of
all Borrowers.
By:
Name:
Title:
Date:
COLLATERAL AGENT USE ONLY
---	---	---
Received by:	______________________	Date:________
Verified by:	______________________	Date:________
Compliance Status:	Yes	No

Exhibit C-2

Loan Confirmation

In accordance with the loan documents, Innovatus Life Sciences Lending Fund I, LP and Innovatus Life Sciences Offshore Fund I-A, LP (collectively, the “Funds”), managed by Innovatus Capital Partners, LLC, please complete the information below on a quarterly basis and sign and date this confirmation. Please then send directly to the Funds administrator, HedgeServ Corporation., the following information related to the Funds’ total investment in MDXHEALTH SA and MDXHEALTH, INC.:

1)	Please provide the following information as it relates to the Funds (Include: Date, Loan Description,<br>Principal Outstanding): Please see table below
Date – For the Quarter Ended	Loan Description	Principal Outstanding
---	---	---
	Total

Please sign, date, and email a copy of your response to HedgeServ at HS InnovatusNAV@HedgeServ.com and copy Accounting@InnovatusCP.com no later than 30 days after quarter end.

CONFIRMATION:

Signature:
Print Name:
Title:
Date:
Phone:

EXHIBIT D

Form of Secured Promissory Note

[see attached]

SECURED PROMISSORY NOTE(Term [A][B][C] Loan)

$___________	Dated: [DATE]

FOR VALUE RECEIVED, the undersigned, MDXHEALTH SA, a limited liability company existing under the laws of Belgium (“Parent”) and MDXHEALTH, INC., a Delaware corporation (“US Sub”; together with Parent, individually and collectively, jointly and severally, “Borrower”) HEREBY PROMISES TO PAY to the order of INNOVATUS LIFE SCIENCES LENDING FUND I, LP (“Lender”) the principal amount of [ ] MILLION DOLLARS ($ ) or such lesser amount as shall equal the outstanding principal balance of the Term [A][B][C] Loan made to Borrower by Lender, plus interest on the aggregate unpaid principal amount of such Term [A][B][C] Loan, at the rates and in accordance with the terms of the Loan and Security Agreement dated August 2, 2022 by and among Borrower, Lender, INNOVATUS LIFE SCIENCES LENDING FUND I, LP, as Collateral Agent, and the other Lenders from time to time party thereto (as amended, restated, supplemented or otherwise modified from time to time, the “Loan Agreement”). If not sooner paid, the entire principal amount and all accrued and unpaid interest hereunder shall be due and payable on the Maturity Date as set forth in the Loan Agreement. Any capitalized term not otherwise defined herein shall have the meaning attributed to such term in the Loan Agreement.

Principal, interest and all other amounts due with respect to the Term [A][B][C] Loan, are payable in lawful money of the United States of America to Lender as set forth in the Loan Agreement and this Secured Promissory Note (this “Note”). The principal amount of this Note and the interest rate applicable thereto, and all payments made with respect thereto, shall be recorded by Lender and, prior to any transfer hereof, endorsed on the grid attached hereto which is part of this Note.

The Loan Agreement, among other things, (a) provides for the making of a secured Term [A][B][C] Loan by Lender to Borrower, and (b) contains provisions for acceleration of the maturity hereof upon the happening of certain stated events.

This Note may not be prepaid except as set forth in Section 2.2 (c) and Section 2.2(d) of the Loan Agreement.

This Note and the obligation of Borrower to repay the unpaid principal amount of the Term [A][B][C] Loan, interest on the Term [A][B][C] Loan and all other amounts due Lender under the Loan Agreement is secured under the Loan Agreement.

Presentment for payment, demand, notice of protest and all other demands and notices of any kind in connection with the execution, delivery, performance and enforcement of this Note are hereby waived.

Borrower shall pay all reasonable fees and expenses, including, without limitation, reasonable attorneys’ fees and costs, incurred by Lender in the enforcement or attempt to enforce any of Borrower’s obligations hereunder not performed when due.

This Note shall be governed by, and construed and interpreted in accordance with, the internal laws of the State of New York.

The ownership of an interest in this Note shall be registered on a record of ownership maintained by Lender or its agent. Notwithstanding anything else in this Note to the contrary, the right to the principal of, and stated interest on, this Note may be transferred only if the transfer is registered on such record of ownership and the transferee is identified as the owner of an interest in the obligation. Borrower shall be entitled to treat the registered holder of this Note (as recorded on such record of ownership) as the owner in fact thereof for all purposes and shall not be bound to recognize any equitable or other claim to or interest in this Note on the part of any other person or entity.

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IN WITNESS WHEREOF, Borrower has caused this Note to be duly executed by one of its officers thereunto duly authorized on the date hereof.

BORROWER:
MDXHEALTH SA
MDXHEALTH, INC.
By:
Name:
Title:

CORPORATE BORROWING CERTIFICATE

BORROWER:	MDXHEALTH INC.	DATE: [DATE]

LENDER:	INNOVATUS LIFE SCIENCES LENDING FUND I, LP, as<br><br>Collateral Agent and Lender

I hereby certify as follows, as of the date set forth above:

I am the Secretary, Assistant Secretary or other officer of Borrower. My title is as set forth below.
Borrower’s exact legal name is set forth above. Borrower is a corporation existing under the laws of the State of Delaware.
Attached hereto as Exhibit A and Exhibit B, respectively, are true, correct and complete copies of (i) Borrower’s Articles/Certificate of Incorporation (including amendments), as filed with the Secretary of State of the state in which Borrower is incorporated as set forth in paragraph 2 above; and (ii) Borrower’s Bylaws. Neither such Articles/Certificate of Incorporation nor such Bylaws have been amended, annulled, rescinded, revoked or supplemented, and such Articles/Certificate of Incorporation and such Bylaws remain in full force and effect as of the date hereof.
Attached hereto as Exhibit C are the specimen signatures of the genuine signatures of officers of Borrower. Each officer of the Borrower indicated on Exhibit C has been duly elected and is, at present, qualified and acting in the office indicated opposite such officer’s name.
Attached hereto as Exhibit D is a true, correct and complete copy of the resolutions of Borrower that were duly and validly adopted by Borrower’s Board of Directors at a duly held meeting of such directors (or pursuant to a unanimous written consent or other authorized corporate action). Such resolutions are in full force and effect as of the date hereof and have not been in any way modified, repealed, rescinded, amended or revoked, and the Lenders may rely on them until each Lender receives written notice of revocation from Borrower.

[Balance of Page Intentionally Left Blank]

By:
Name:
Title:

*** If the Secretary, Assistant Secretary orother certifying officer executing above is designated by the resolutions set forth in paragraph 4 as one of the authorized signing officers,this Certificate must also be signed by a second authorized officer or director of Borrower.

I, the___________________of Borrower, hereby certify as to paragraphs 1 through 5 above, as of the date set forth above.
[print title]
By:
---
Name:
Title:

Exhibit A

Articles/Certificate of Incorporation

Exhibit B

Bylaws

Exhibit C

Incumbency

Name	Title	Signature	Authorized to <br><br>Add or Remove <br><br>Signatories
			☐
			☐
			☐
			☐

Exhibit D

Resolutions

ANNEX I

Collateral Agent and Lender Terms

1. Appointmentof Collateral Agent.

Each Lender hereby appoints INNOVATUS LIFE SCIENCES LENDING FUND I, LP (together with any successor Collateral Agent pursuant to Section 7 of this Annex I) as Collateral Agent under the Loan Documents (including as representative within the meaning of Article 5 of the Belgian Act of 15 December 2004 on financial collateral and Article 3 of the Belgian Act of 11 July 2013 on proprietary security on movable assets as set out in Title XVII of Book III of the Belgian Civil Code) and authorizes Collateral Agent to (i) execute and deliver the Loan Documents and accept delivery thereof on its behalf from Borrower, (ii) take such action on its behalf and to exercise all rights, powers and remedies and perform the duties as are expressly delegated to Collateral Agent under such Loan Documents and (iii) exercise such powers as are reasonably incidental thereto.

Without limiting the generality of clause (a) above, Collateral Agent shall have the sole and exclusive right and authority (to the exclusion of the Lenders), and is hereby authorized, to (i) act as the disbursing and collecting agent for the Lenders with respect to all payments and collections arising in connection with the Loan Documents (including in any other bankruptcy, insolvency or similar proceeding), and each Person making any payment in connection with any Loan Document to any Lender is hereby authorized to make such payment to Collateral Agent, (ii) file and prove claims and file other documents necessary or desirable to allow the claims of Collateral Agent and Lenders with respect to any Obligation in any bankruptcy, insolvency or similar proceeding (but not to vote, consent or otherwise act on behalf of such Lender), (iii) act as collateral agent for Collateral Agent and each Lender for purposes of the perfection of all Liens created by the Loan Documents and all other purposes stated therein, (iv) manage, supervise and otherwise deal with the Collateral, (v) take such other action as is necessary or desirable to maintain the perfection and priority of the Liens created or purported to be created by the Loan Documents, (vi) except as may be otherwise specified in any Loan Document, exercise all remedies given to Collateral Agent and the other Lenders with respect to Borrower and/or the Collateral, whether under the Loan Documents, applicable Requirements of Law or otherwise and (vii) execute any amendment, consent or waiver under the Loan Documents on behalf of any Lender that has consented in writing to such amendment, consent or waiver; provided, however, that Collateral Agent hereby appoints, authorizes and directs each Lender to act as collateral sub-agent for Collateral Agent and the Lenders for purposes of the perfection of all Liens with respect to the Collateral, including any Deposit Account maintained by Borrower with, and cash and Cash Equivalents held by, such Lender, and may further authorize and direct the Lenders to take further actions as collateral sub-agents for purposes of enforcing such Liens or otherwise to transfer the Collateral subject thereto to Collateral Agent, and each Lender hereby agrees to take such further actions to the extent, and only to the extent, so authorized and directed. Collateral Agent may, upon any term or condition it specifies, delegate or exercise any of its rights, powers and remedies under, and delegate or perform any of its duties or any other action with respect to, any Loan Document by or through any trustee, co-agent, employee, attorney-in-fact and any other Person (including any Lender). Any such Person shall benefit from this Annex I to the extent provided by Collateral Agent.

Under the Loan Documents, Collateral Agent (i) is acting solely on behalf of the Lenders, with duties that are entirely administrative in nature, notwithstanding the use of the defined term “Collateral Agent”, the terms “agent”, “Collateral Agent” and “collateral agent” and similar terms in any Loan Document to refer to Collateral Agent, which terms are used for title purposes only, (ii) is not assuming any obligation under any Loan Document other than as expressly set forth therein or any role as agent, fiduciary or trustee of or for any Lender or any other Person and (iii) shall have no implied functions, responsibilities, duties, obligations or other liabilities under any Loan Document, and each Lender, by accepting the benefits of the Loan Documents, hereby waives and agrees not to assert any claim against Collateral Agent based on the roles, duties and legal relationships expressly disclaimed in clauses (i) through (iii) above. Except as expressly set forth in the Loan Documents, Collateral Agent shall not have any duty to disclose, and shall not be liable for failure to disclose, any information relating to Borrower or any of its Subsidiaries that is communicated to or obtained by [LENDER 2] or any of its Affiliates in any capacity.

2. BindingEffect; Use of Discretion; E-Systems.

(a) Each Lender, by accepting the benefits of the Loan Documents, agrees that (i) any action taken by Collateral Agent or Required Lenders (or, if expressly required in any Loan Document, a greater proportion of the Lenders) in accordance with the provisions of the Loan Documents, (ii) any action taken by Collateral Agent in reliance upon the instructions of Required Lenders (or, where so required, such greater proportion) and (iii) the exercise by Collateral Agent or Required Lenders (or, where so required, such greater proportion) of the powers set forth herein or therein, together with such other powers as are reasonably incidental thereto, shall be authorized and binding upon all of Lenders.

If Collateral Agent shall request instructions from Required Lenders or all affected Lenders with respect to any act or action (including failure to act) in connection with any Loan Document, then Collateral Agent shall be entitled to refrain from such act or taking such action unless and until Collateral Agent shall have received instructions from Required Lenders or all affected Lenders, as the case may be, and Collateral Agent shall not incur liability to any Person by reason of so refraining. Collateral Agent shall be fully justified in failing or refusing to take any action under any Loan Document (i) if such action would, in the opinion of Collateral Agent, be contrary to any Requirement of Law or any Loan Document, (ii) if such action would, in the opinion of Collateral Agent, expose Collateral Agent to any potential liability under any Requirement of Law or (iii) if Collateral Agent shall not first be indemnified to its satisfaction against any and all liability and expense which may be incurred by it by reason of taking or continuing to take any such action. Without limiting the foregoing, no Lender shall have any right of action whatsoever against Collateral Agent as a result of Collateral Agent acting or refraining from acting under any Loan Document in accordance with the instructions of Required Lenders or all affected Lenders, as applicable.

Collateral Agent is hereby authorized by Borrower and each Lender to establish procedures (and to amend such procedures from time to time) to facilitate administration and servicing of the Term Loan and other matters incidental thereto. Without limiting the generality of the foregoing, Collateral Agent is hereby authorized to establish procedures to make available or deliver, or to accept, notices, documents (including, without limitation, borrowing base certificates) and similar items on, by posting to or submitting and/or completion, on E-Systems. Borrower and each Lender acknowledges and agrees that the use of transmissions via an E-System or electronic mail is not necessarily secure and that there are risks associated with such use, including risks of interception, disclosure and abuse, and Borrower and each Lender assumes and accepts such risks by hereby authorizing the transmission via E-Systems or electronic mail. Each “e-signature” on any such posting shall be deemed sufficient to satisfy any requirement for a “signature”, and each such posting shall be deemed sufficient to satisfy any requirement for a “writing”, in each case including pursuant to any Loan Document, any applicable provision of any Code, the federal Uniform Electronic Transactions Act, the Electronic Signatures in Global and National Commerce Act and any substantive or procedural Requirement of Law governing such subject matter. All uses of an E-System shall be governed by and subject to, in addition to this Section, the separate terms, conditions and privacy policy posted or referenced in such E-System (or such terms, conditions and privacy policy as may be updated from time to time, including on such E-System) and related contractual obligations executed by Collateral Agent, Borrower and/or Lenders in connection with the use of such E-System. ALL E-SYSTEMS AND ELECTRONIC TRANSMISSIONS SHALL BE PROVIDED “AS IS” AND “AS AVAILABLE”. NO REPRESENTATION OR WARRANTY OF ANY KIND IS MADE BY AGENT, ANY LENDER OR ANY OF THEIR RELATED PERSONS IN CONNECTION WITH ANY E-SYSTEMS.

3. CollateralAgent’s Reliance, Etc. Collateral Agent may, without incurring any liability hereunder, (a) consult with any of its Related Persons and, whether or not selected by it, any other advisors, accountants and other experts (including advisors to, and accountants and experts engaged by, Borrower) and (b) rely and act upon any document and information (including those transmitted by electronic transmission) and any telephone message or conversation, in each case believed by it to be genuine and transmitted, signed or otherwise authenticated by the appropriate parties. None of Collateral Agent and its Related Persons shall be liable for any action taken or omitted to be taken by any of them under or in connection with any Loan Document, and each Lender and Borrower hereby waives and shall not assert (and Borrower shall cause its Subsidiaries to waive and agree not to assert) any right, claim or cause of action based thereon, except to the extent of liabilities resulting from the gross negligence or willful misconduct of Collateral Agent or, as the case may be, such Related Person (each as determined in a final, non-appealable judgment of a court of competent jurisdiction) in connection with the duties of Collateral Agent expressly set forth herein. Without limiting the foregoing, Collateral Agent: (i) shall not be responsible or otherwise incur liability for any action or omission taken in reliance upon the instructions of the Required Lenders or for the actions or omissions of any of its Related Persons, except to the extent that a court of competent jurisdiction determines in a final non-appealable judgment that Collateral Agent acted with gross negligence or willful misconduct in the selection of such Related Person; (ii) shall not be responsible to any Lender or other Person for the due execution, legality, validity, enforceability, effectiveness, genuineness, sufficiency or value of, or the attachment, perfection or priority of any Lien created or purported to be created under or in connection with, any Loan Document; (iii) makes no warranty or representation, and shall not be responsible, to any Lender or other Person for any statement, document, information, representation or warranty made or furnished by or on behalf of Borrower or any Related Person of Borrower in connection with any Loan Document or any transaction contemplated therein or any other document or information with respect to Borrower, whether or not transmitted or (except for documents expressly required under any Loan Document to be transmitted to the Lenders) omitted to be transmitted by Collateral Agent, including as to completeness, accuracy, scope or adequacy thereof, or for the scope, nature or results of any due diligence performed by Collateral Agent in connection with the Loan Documents; and (iv) shall not have any duty to ascertain or to inquire as to the performance or observance of any provision of any Loan Document, whether any condition set forth in any Loan Document is satisfied or waived, as to the financial condition of Borrower or as to the existence or continuation or possible occurrence or continuation of any Event of Default, and shall not be deemed to have notice or Knowledge of such occurrence or continuation unless it has received a notice from Borrower or any Lender describing such Event of Default that is clearly labeled “notice of default” (in which case Collateral Agent shall promptly give notice of such receipt to all Lenders, provided that Collateral Agent shall not be liable to any Lender for any failure to do so, except to the extent that such failure is attributable to Collateral Agent’s gross negligence or willful misconduct as determined by a final non-appealable judgment of a court of competent jurisdiction); and, for each of the items set forth in clauses (i) through (iv) above, each Lender and Borrower hereby waives and agrees not to assert (and Borrower shall cause its Subsidiaries to waive and agree not to assert) any right, claim or cause of action it might have against Collateral Agent based thereon.

4. CollateralAgent Individually. Collateral Agent and its Affiliates may make loans and other extensions of credit to, acquire stock and stock equivalents of, engage in any kind of business with, Borrower or any Affiliate of Borrower as though it were not acting as Collateral Agent and may receive separate fees and other payments therefor. To the extent Collateral Agent or any of its Affiliates makes the Term Loan or otherwise becomes a Lender hereunder, it shall have and may exercise the same rights and powers hereunder and shall be subject to the same obligations and liabilities as any other Lender and the terms “Lender”, “Required Lender” and any similar terms shall, except where otherwise expressly provided in any Loan Document, include, without limitation, Collateral Agent or such Affiliate, as the case may be, in its individual capacity as Lender, or as one of the Required Lenders.

5. Lender CreditDecision; Collateral Agent Report. Each Lender acknowledges that it shall, independently and without reliance upon Collateral Agent, any Lender or any of their Related Persons or upon any document solely or in part because such document was transmitted by Collateral Agent or any of its Related Persons, conduct its own independent investigation of the financial condition and affairs of Borrower and make and continue to make its own credit decisions in connection with entering into, and taking or not taking any action under, any Loan Document or with respect to any transaction contemplated in any Loan Document, in each case based on such documents and information as it shall deem appropriate. Except for documents expressly required by any Loan Document to be transmitted by Collateral Agent to the Lenders, Collateral Agent shall not have any duty or responsibility to provide any Lender with any credit or other information concerning the business, prospects, operations, Property, financial and other condition or creditworthiness of Borrower or any Affiliate of Borrower that may come in to the possession of Collateral Agent or any of its Related Persons. Each Lender agrees that is shall not rely on any field examination, audit or other report provided by Collateral Agent or its Related Persons (a “Collateral Agent Report”). Each Lender further acknowledges that any Collateral Agent Report (a) is provided to the Lenders solely as a courtesy, without consideration, and based upon the understanding that such Lender will not rely on such Collateral Agent Report, (b) was prepared by Collateral Agent or its Related Persons based upon information provided by Borrower solely for Collateral Agent’s own internal use, and (c) may not be complete and may not reflect all information and findings obtained by Collateral Agent or its Related Persons regarding the operations and condition of Borrower. Neither Collateral Agent nor any of its Related Persons makes any representations or warranties of any kind with respect to (i) any existing or proposed financing, (ii) the accuracy or completeness of the information contained in any Collateral Agent Report or in any related documentation, (iii) the scope or adequacy of Collateral Agent’s and its Related Persons’ due diligence, or the presence or absence of any errors or omissions contained in any Collateral Agent Report or in any related documentation, and (iv) any work performed by Collateral Agent or Collateral Agent’s Related Persons in connection with or using any Collateral Agent Report or any related documentation. Neither Collateral Agent nor any of its Related Persons shall have any duties or obligations in connection with or as a result of any Lender receiving a copy of any Collateral Agent Report. Without limiting the generality of the forgoing, neither Collateral Agent nor any of its Related Persons shall have any responsibility for the accuracy or completeness of any Collateral Agent Report, or the appropriateness of any Collateral Agent Report for any Lender’s purposes, and shall have no duty or responsibility to correct or update any Collateral Agent Report or disclose to any Lender any other information not embodied in any Collateral Agent Report, including any supplemental information obtained after the date of any Collateral Agent Report. Each Lender releases, and agrees that it will not assert, any claim against Collateral Agent or its Related Persons that in any way relates to any Collateral Agent Report or arises out of any Lender having access to any Collateral Agent Report or any discussion of its contents, and agrees to indemnify and hold harmless Collateral Agent and its Related Persons from all claims, liabilities and expenses relating to a breach by any Lender arising out of such Lender’s access to any Collateral Agent Report or any discussion of its contents.

**6. Indemnification.**Each Lender agrees to reimburse Collateral Agent and each of its Related Persons (to the extent not reimbursed by Borrower as required under the Loan Documents) promptly upon demand for its Pro Rata Share of any out-of-pocket costs and expenses (including, without limitation, fees, charges and disbursements of financial, legal and other advisors and any taxes or insurance paid in the name of, or on behalf of, Borrower) incurred by Collateral Agent or any of its Related Persons in connection with the preparation, syndication, execution, delivery, administration, modification, amendment, consent, waiver or enforcement of, or the taking of any other action (whether through negotiations, through any work-out, bankruptcy, restructuring or other legal or other proceeding (including, without limitation, preparation for and/or response to any subpoena or request for document production relating thereto) or otherwise) in respect of, or legal advice with respect to, its rights or responsibilities under, any Loan Document. Each Lender further agrees to indemnify Collateral Agent and each of its Related Persons (to the extent not reimbursed by Borrower as required under the Loan Documents), ratably according to its Pro Rata Share, from and against any and all liabilities, obligations, losses, damages, penalties, actions, judgments, suits, costs, expenses or disbursements of any kind or nature whatsoever (including, to the extent not indemnified by the applicable Lender, taxes, interests and penalties imposed for not properly withholding or backup withholding on payments made to or for the account of any Lender) that may be imposed on, incurred by, or asserted against Collateral Agent or any of its Related Persons in any matter relating to or arising out of, in connection with or as a result of any Loan Document or any other act, event or transaction related, contemplated in or attendant to any such document, or, in each case, any action taken or omitted to be taken by Collateral Agent or any of its Related Persons under or with respect to the foregoing; provided that no Lender shall be liable to Collateral Agent or any of its Related Persons under this Section 6 of this Annex I to the extent such liability has resulted from the gross negligence or willful misconduct of Collateral Agent or, as the case may be, such Related Person, as determined by a final non-appealable judgment of a court of competent jurisdiction. To the extent required by any applicable Requirement of Law, Collateral Agent may withhold from any payment to any Lender under a Loan Document an amount equal to any applicable withholding tax. If the Internal Revenue Service or any other Governmental Authority asserts a claim that Collateral Agent did not properly withhold tax from amounts paid to or for the account of any Lender for any reason, or if Collateral Agent reasonably determines that it was required to withhold taxes from a prior payment to or for the account of any Lender but failed to do so, such Lender shall promptly indemnify Collateral Agent fully for all amounts paid, directly or indirectly, by Collateral Agent as tax or otherwise, including penalties and interest, and together with all expenses incurred by Collateral Agent. Collateral Agent may offset against any payment to any Lender under a Loan Document, any applicable withholding tax that was required to be withheld from any prior payment to such Lender but which was not so withheld, as well as any other amounts for which Collateral Agent is entitled to indemnification from such Lender under the immediately preceding sentence of this Section 6 of this Annex I.

7. SuccessorCollateral Agent. Collateral Agent may resign at any time by delivering notice of such resignation to the Lenders and Borrower, effective on the date set forth in such notice or, if no such date is set forth therein, upon the date such notice shall be effective, in accordance with the terms of this Section 7 of this Annex I. If Collateral Agent delivers any such notice, the Required Lenders shall have the right, with Borrower’s prior written consent (unless an Event of Default has occurred and is continuing at the time of the appointment) to appoint a successor Collateral Agent. If, after 30 days after the date of the retiring Collateral Agent’s notice of resignation, no successor Collateral Agent has been appointed by the Required Lenders that has accepted such appointment, then the retiring Collateral Agent may, on behalf of the Lenders, appoint a successor Collateral Agent from among the Lenders. Effective immediately upon its resignation, (a) the retiring Collateral Agent shall be discharged from its duties and obligations under the Loan Documents, (b) the Lenders shall assume and perform all of the duties of Collateral Agent until a successor Collateral Agent shall have accepted a valid appointment hereunder, (c) the retiring Collateral Agent and its Related Persons shall no longer have the benefit of any provision of any Loan Document other than with respect to any actions taken or omitted to be taken while such retiring Collateral Agent was, or because such Collateral Agent had been, validly acting as Collateral Agent under the Loan Documents, and (iv) subject to its rights under Section 2(b) of this Annex I, the retiring Collateral Agent shall take such action as may be reasonably necessary to assign to the successor Collateral Agent its rights as Collateral Agent under the Loan Documents. Effective immediately upon its acceptance of a valid appointment as Collateral Agent, a successor Collateral Agent shall succeed to, and become vested with, all the rights, powers, privileges and duties of the retiring Collateral Agent under the Loan Documents.

8. Releaseof Collateral. Each Lender hereby consents to the release and hereby directs Collateral Agent to release (or in the case of clause (b)(ii) below, release or subordinate) the following:

(a) any Guarantor or Subsidiary “co-Borrower” if all of the stock of such Subsidiary owned by Borrower is sold or transferred in a transaction permitted under the Loan Documents (including pursuant to a valid waiver or consent), to the extent that, after giving effect to such transaction, such Subsidiary would not be required to guaranty any Obligations pursuant to any Loan Document; and

(b) any Lien held by Collateral Agent for the benefit of itself and the Lenders against (i) any Collateral that is sold or otherwise disposed of by Borrower in a transaction permitted by the Loan Documents (including pursuant to a valid waiver or consent), (ii) any Collateral subject to a Lien that is expressly permitted under clause (c) of the definition of the term “Permitted Lien” and (iii) all of the Collateral and Borrower, upon (A) termination of all of the Term Loan Commitments, (B) payment in full in cash of all of the Obligations that Collateral Agent has theretofore been notified in writing by the holder of such Obligation are then due and payable, and (C) to the extent requested by Collateral Agent, receipt by Collateral Agent and Lenders of liability releases from Borrower in form and substance acceptable to Collateral Agent (the satisfaction of the conditions in this clause (iii), the “Termination Date”).

9. Setoffand Sharing of Payments. In addition to any rights now or hereafter granted under any applicable requirement of law and not by way of limitation of any such rights, upon the occurrence and during the continuance of any Event of Default and subject to Section 10(d) of this Annex I, each Lender is hereby authorized at any time or from time to time upon the direction of Collateral Agent, without notice to Borrower or any other Person, any such notice being hereby expressly waived, to setoff and to appropriate and to apply any and all balances held by it at any of its offices for the account of Borrower (regardless of whether such balances are then due to Borrower) and any other properties or assets at any time held or owing by that Lender or that holder to or for the credit or for the account of Borrower against and on account of any of the Obligations that are not paid when due. Any Lender exercising a right of setoff or otherwise receiving any payment on account of the Obligations in excess of its Pro Rata Share thereof shall purchase for cash (and the other Lenders or holders shall sell) such participations in each such other Lender’s or holder’s Pro Rata Share of the Obligations as would be necessary to cause such Lender to share the amount so offset or otherwise received with each other Lender or holder in accordance with their respective Pro Rata Shares of the Obligations. Borrower agrees, to the fullest extent permitted by law, that (a) any Lender may exercise its right to offset with respect to amounts in excess of its Pro Rata Share of the Obligations and may purchase participations in accordance with the preceding sentence and (b) any Lender so purchasing a participation in the Term Loan made or other Obligations held by other Lenders or holders may exercise all rights of offset, bankers’ lien, counterclaim or similar rights with respect to such participation as fully as if such Lender or holder were a direct holder of the Term Loan and the other Obligations in the amount of such participation. Notwithstanding the foregoing, if all or any portion of the offset amount or payment otherwise received is thereafter recovered from the Lender that has exercised the right of offset, the purchase of participations by that Lender shall be rescinded and the purchase price restored without interest.

10. Advances; Payments; Non-Funding Lenders; Actions in Concert.

(a) Advances; Payments. If Collateral Agent receives any payment with respect to the Term Loan for the account of Lenders on or prior to 2:00 p.m. (New York time) on any Business Day, Collateral Agent shall pay to each applicable Lender such Lender’s Pro Rata Share of such payment on such Business Day. If Collateral Agent receives any payment with respect to the Term Loan for the account of Lenders after 2:00 p.m. (New York time) on any Business Day, Collateral Agent shall pay to each applicable Lender such Lender’s Pro Rata Share of such payment on the next Business Day.

(b) Return of Payments.

(i) If Collateral Agent pays an amount to a Lender under this Agreement in the belief or expectation that a related payment has been or will be received by Collateral Agent from Borrower and such related payment is not received by Collateral Agent, then Collateral Agent will be entitled to recover such amount (including interest accruing on such amount at the rate otherwise applicable to such Obligation) from such Lender on demand without setoff, counterclaim or deduction of any kind.

(ii) If Collateral Agent determines at any time that any amount received by Collateral Agent under any Loan Document must be returned to Borrower or paid to any other Person pursuant to any insolvency law or otherwise, then, notwithstanding any other term or condition of any Loan Document, Collateral Agent will not be required to distribute any portion thereof to any Lender. In addition, each Lender will repay to Collateral Agent on demand any portion of such amount that Collateral Agent has distributed to such Lender, together with interest at such rate, if any, as Collateral Agent is required to pay to Borrower or such other Person, without setoff, counterclaim or deduction of any kind and Collateral Agent will be entitled to set off against future distributions to such Lender any such amounts (with interest) that are not repaid on demand.

(i) Unless Collateral Agent shall have received notice from a Lender prior to the date of any Term Loan that such Lender will not make available to Collateral Agent such Lender’s Pro Rata Share of such Term Loan, Collateral Agent may assume that such Lender will make such amount available to it on the date of such Term Loan in accordance with Section 2(b) of this Annex I, and Collateral Agent may (but shall not be obligated to), in reliance upon such assumption, make available a corresponding amount for the account of Borrower on such date. If and to the extent that such Lender shall not have made such amount available to Collateral Agent, such Lender and Borrower severally agree to repay to Collateral Agent forthwith on demand such corresponding amount together with interest thereon, for each day from the day such amount is made available to Borrower until the day such amount is repaid to Collateral Agent, at a rate per annum equal to the interest rate applicable to the Obligation that would have been created when Collateral Agent made available such amount to Borrower had such Lender made a corresponding payment available. If such Lender shall repay such corresponding amount to Collateral Agent, the amount so repaid shall constitute such Lender’s portion of such Term Loan for purposes of this Agreement.

(ii) To the extent that any Lender has failed to fund any Term Loan or any other payments required to be made by it under the Loan Documents after any such Term Loan is required to be made or such payment is due (a “Non-Funding Lender”), Collateral Agent shall be entitled to set off the funding short-fall against that Non-Funding Lender’s Pro Rata Share of all payments received from Borrower. The failure of any Non-Funding Lender to make any Term Loan or any payment required by it hereunder shall not relieve any other Lender (each such other Lender, an “Other Lender”) of its obligations to make such Term Loan, but neither any Other Lender nor Collateral Agent shall be responsible for the failure of any Non-Funding Lender to make such Term Loan or make any other payment required hereunder. Notwithstanding anything set forth herein to the contrary, a Non-Funding Lender shall not have any voting or consent rights under or with respect to any Loan Document or constitute a “Lender” (or be included in the calculation of “Required Lender” hereunder) for any voting or consent rights under or with respect to any Loan Document. At Borrower’s request, Collateral Agent or a Person reasonably acceptable to Collateral Agent shall have the right with Collateral Agent’s consent and in Collateral Agent’s sole discretion (but Collateral Agent or any such Person shall have no obligation) to purchase from any Non-Funding Lender, and each Lender agrees that if it becomes a Non-Funding Lender it shall, at Collateral Agent’s request, sell and assign to Collateral Agent or such Person, all of the Term Loan Commitment (if any), and all of the outstanding Term Loan of that Non-Funding Lender for an amount equal to the aggregate outstanding principal balance of the Term Loan held by such Non-Funding Lender and all accrued interest with respect thereto through the date of sale, such purchase and sale to be consummated pursuant to an executed assignment agreement in form and substance reasonably satisfactory to, and acknowledged by, Collateral Agent.

(d) Actions in Concert. Anything in this Agreement to the contrary notwithstanding, each Lender hereby agrees with each other Lender that no Lender shall take any action to protect or enforce its rights arising out of any Loan Document (including exercising any rights of setoff) without first obtaining the prior written consent of Collateral Agent or Required Lenders, it being the intent of Lenders that any such action to protect or enforce rights under any Loan Document shall be taken in concert and at the direction or with the consent of Collateral Agent or Required Lenders.

ANNEX X

Management Plan (to be delivered in connectionwith Section 6.12 and in accordance with the timeline contemplated therein)

ANNEX Y

LOAN INTEREST RATE AND PAYMENT OF PRINCIPAL(Term Loan)

PLEASE SEE ATTACHED

Month	Beginning Date	Ending Date	Payment Date	****	Beginning Loan Balance	Greater of Prime Rate or 4.00%	Interest Rate	****	Interest Earned	****	PIK Interest	****	Cash Interest	****	Pricipal Amortization	****	Total Payment	Tranche B/ C Funding	****	Ending Loan Balance
1	8/2/22	8/31/22	9/1/22	$	35,000,000.00	5.50%	9.75%	$	280,479.45	$	64,726.03	$	215,753.42		--	$	215,753.42	--	$	35,064,726.03
2	9/1/22	9/30/22	10/1/22	$	35,064,726.03	5.50%	9.75%	$	280,998.15	$	64,845.73	$	216,152.42		--	$	216,152.42	--	$	35,129,571.75
3	10/1/22	10/31/22	11/1/22	$	35,129,571.75	5.50%	9.75%	$	290,901.73	$	67,131.17	$	223,770.56		--	$	223,770.56	--	$	35,196,702.92
4	11/1/22	11/30/22	12/1/22	$	35,196,702.92	5.50%	9.75%	$	282,055.77	$	65,089.79	$	216,965.98		--	$	216,965.98	--	$	35,261,792.71
5	12/1/22	12/31/22	1/1/23	$	35,261,792.71	5.50%	9.75%	$	291,996.63	$	67,383.84	$	224,612.79		--	$	224,612.79	--	$	35,329,176.55
6	1/1/23	1/31/23	2/1/23	$	35,329,176.55	5.50%	9.75%	$	292,554.62	$	67,512.60	$	225,042.02		--	$	225,042.02	--	$	35,396,689.16
7	2/1/23	2/28/23	3/1/23	$	35,396,689.16	5.50%	9.75%	$	264,747.84	$	61,095.66	$	203,652.18		--	$	203,652.18	--	$	35,457,784.81
8	3/1/23	3/31/23	4/1/23	$	35,457,784.81	5.50%	9.75%	$	293,619.60	$	67,758.37	$	225,861.23		--	$	225,861.23	--	$	35,525,543.18
9	4/1/23	4/30/23	5/1/23	$	35,525,543.18	5.50%	9.75%	$	284,691.00	$	65,697.92	$	218,993.07		--	$	218,993.07	--	$	35,591,241.10
10	5/1/23	5/31/23	6/1/23	$	35,591,241.10	5.50%	9.75%	$	294,724.73	$	68,013.40	$	226,711.33		--	$	226,711.33	--	$	35,659,254.50
11	6/1/23	6/30/23	7/1/23	$	35,659,254.50	5.50%	9.75%	$	285,762.52	$	65,945.20	$	219,817.32		--	$	219,817.32	--	$	35,725,199.70
12	7/1/23	7/31/23	8/1/23	$	35,725,199.70	5.50%	9.75%	$	295,834.02	$	68,269.39	$	227,564.63		--	$	227,564.63	--	$	35,793,469.09
13	8/1/23	8/31/23	9/1/23	$	35,793,469.09	5.50%	9.75%	$	296,399.34	$	68,399.85	$	227,999.49		--	$	227,999.49	--	$	35,861,868.94
14	9/1/23	9/30/23	10/1/23	$	35,861,868.94	5.50%	9.75%	$	287,386.21	$	66,319.89	$	221,066.32		--	$	221,066.32	--	$	35,928,188.83
15	10/1/23	10/31/23	11/1/23	$	35,928,188.83	5.50%	9.75%	$	297,514.93	$	68,657.29	$	228,857.64		--	$	228,857.64	--	$	35,996,846.12
16	11/1/23	11/30/23	12/1/23	$	35,996,846.12	5.50%	9.75%	$	288,467.88	$	66,569.51	$	221,898.37		--	$	221,898.37	--	$	36,063,415.63
17	12/1/23	12/31/23	1/1/24	$	36,063,415.63	5.50%	9.75%	$	298,634.72	$	68,915.71	$	229,719.02		--	$	229,719.02	--	$	36,132,331.34
18	1/1/24	1/31/24	2/1/24	$	36,132,331.34	5.50%	9.75%	$	299,205.40	$	69,047.40	$	230,158.00		--	$	230,158.00	--	$	36,201,378.74
19	2/1/24	2/29/24	3/1/24	$	36,201,378.74	5.50%	9.75%	$	280,436.71	$	64,716.16	$	215,720.54		--	$	215,720.54	--	$	36,266,094.90
20	3/1/24	3/31/24	4/1/24	$	36,266,094.90	5.50%	9.75%	$	300,313.07	$	69,303.02	$	231,010.06		--	$	231,010.06	--	$	36,335,397.92
21	4/1/24	4/30/24	5/1/24	$	36,335,397.92	5.50%	9.75%	$	291,180.93	$	67,195.60	$	223,985.33		--	$	223,985.33	--	$	36,402,593.52
22	5/1/24	5/31/24	6/1/24	$	36,402,593.52	5.50%	9.75%	$	301,443.39	$	69,563.86	$	231,879.53		--	$	231,879.53	--	$	36,472,157.38
23	6/1/24	6/30/24	7/1/24	$	36,472,157.38	5.50%	9.75%	$	292,276.88	$	67,448.51	$	224,828.37		--	$	224,828.37	--	$	36,539,605.89
24	7/1/24	7/31/24	8/1/24	$	36,539,605.89	5.50%	9.75%	$	302,577.97	$	69,825.69	$	232,752.28		--	$	232,752.28	--	$	36,609,431.57
25	8/1/24	8/31/24	9/1/24	$	36,609,431.57	5.50%	9.75%	$	303,156.18	$	69,959.12	$	233,197.06		--	$	233,197.06	--	$	36,679,390.69
26	9/1/24	9/30/24	10/1/24	$	36,679,390.69	5.50%	9.75%	$	293,937.58	$	67,831.75	$	226,105.83		--	$	226,105.83	--	$	36,747,222.44
27	10/1/24	10/31/24	11/1/24	$	36,747,222.44	5.50%	9.75%	$	304,297.21	$	70,222.43	$	234,074.77		--	$	234,074.77	--	$	36,817,444.87
28	11/1/24	11/30/24	12/1/24	$	36,817,444.87	5.50%	9.75%	$	295,043.91	$	68,087.06	$	226,956.85		--	$	226,956.85	--	$	36,885,531.93
29	12/1/24	12/31/24	1/1/25	$	36,885,531.93	5.50%	9.75%	$	305,442.52	$	70,486.74	$	234,955.79		--	$	234,955.79	--	$	36,956,018.67
30	1/1/25	1/31/25	2/1/25	$	36,956,018.67	5.50%	9.75%	$	306,026.21	$	70,621.43	$	235,404.78		--	$	235,404.78	--	$	37,026,640.10
31	2/1/25	2/28/25	3/1/25	$	37,026,640.10	5.50%	9.75%	$	276,938.98	$	63,909.00	$	213,029.98		--	$	213,029.98	--	$	37,090,549.09
32	3/1/25	3/31/25	4/1/25	$	37,090,549.09	5.50%	9.75%	$	307,140.23	$	70,878.52	$	236,261.72		--	$	236,261.72	--	$	37,161,427.61
33	4/1/25	4/30/25	5/1/25	$	37,161,427.61	5.50%	9.75%	$	297,800.48	$	68,723.19	$	229,077.29		--	$	229,077.29	--	$	37,230,150.80
34	5/1/25	5/31/25	6/1/25	$	37,230,150.80	5.50%	9.75%	$	308,296.25	$	71,145.29	$	237,150.96		--	$	237,150.96	--	$	37,301,296.08
35	6/1/25	6/30/25	7/1/25	$	37,301,296.08	5.50%	9.75%	$	298,921.35	$	68,981.85	$	229,939.50		--	$	229,939.50	--	$	37,370,277.93
36	7/1/25	7/31/25	8/1/25	$	37,370,277.93	5.50%	9.75%	$	309,456.62	$	71,413.07	$	238,043.55		--	$	238,043.55	--	$	37,441,691.00
37	8/1/25	8/31/25	9/1/25	$	37,441,691.00	5.50%	9.75%	$	310,047.98		--	$	310,047.98		--	$	310,047.98	--	$	37,441,691.00
38	9/1/25	9/30/25	10/1/25	$	37,441,691.00	5.50%	9.75%	$	300,046.43		--	$	300,046.43		--	$	300,046.43	--	$	37,441,691.00
39	10/1/25	10/31/25	11/1/25	$	37,441,691.00	5.50%	9.75%	$	310,047.98		--	$	310,047.98		--	$	310,047.98	--	$	37,441,691.00
40	11/1/25	11/30/25	12/1/25	$	37,441,691.00	5.50%	9.75%	$	300,046.43		--	$	300,046.43		--	$	300,046.43	--	$	37,441,691.00
41	12/1/25	12/31/25	1/1/26	$	37,441,691.00	5.50%	9.75%	$	310,047.98		--	$	310,047.98		--	$	310,047.98	--	$	37,441,691.00
42	1/1/26	1/31/26	2/1/26	$	37,441,691.00	5.50%	9.75%	$	310,047.98		--	$	310,047.98		--	$	310,047.98	--	$	37,441,691.00
43	2/1/26	2/28/26	3/1/26	$	37,441,691.00	5.50%	9.75%	$	280,043.33		--	$	280,043.33		--	$	280,043.33	--	$	37,441,691.00
44	3/1/26	3/31/26	4/1/26	$	37,441,691.00	5.50%	9.75%	$	310,047.98		--	$	310,047.98		--	$	310,047.98	--	$	37,441,691.00
45	4/1/26	4/30/26	5/1/26	$	37,441,691.00	5.50%	9.75%	$	300,046.43		--	$	300,046.43		--	$	300,046.43	--	$	37,441,691.00
46	5/1/26	5/31/26	6/1/26	$	37,441,691.00	5.50%	9.75%	$	310,047.98		--	$	310,047.98		--	$	310,047.98	--	$	37,441,691.00
47	6/1/26	6/30/26	7/1/26	$	37,441,691.00	5.50%	9.75%	$	300,046.43		--	$	300,046.43		--	$	300,046.43	--	$	37,441,691.00
48	7/1/26	7/31/26	8/1/26	$	37,441,691.00	5.50%	9.75%	$	310,047.98		--	$	310,047.98		--	$	310,047.98	--	$	37,441,691.00
49	8/1/26	8/31/26	9/1/26	$	37,441,691.00	5.50%	9.75%	$	310,047.98		--	$	310,047.98	$	3,120,140.92	$	3,430,188.89	--	$	34,321,550.08
50	9/1/26	9/30/26	10/1/26	$	34,321,550.08	5.50%	9.75%	$	275,042.56		--	$	275,042.56	$	3,120,140.92	$	3,395,183.48	--	$	31,201,409.17
51	10/1/26	10/31/26	11/1/26	$	31,201,409.17	5.50%	9.75%	$	258,373.31		--	$	258,373.31	$	3,120,140.92	$	3,378,514.23	--	$	28,081,268.25
52	11/1/26	11/30/26	12/1/26	$	28,081,268.25	5.50%	9.75%	$	225,034.82		--	$	225,034.82	$	3,120,140.92	$	3,345,175.74	--	$	24,961,127.33
53	12/1/26	12/31/26	1/1/27	$	24,961,127.33	5.50%	9.75%	$	206,698.65		--	$	206,698.65	$	3,120,140.92	$	3,326,839.57	--	$	21,840,986.42
54	1/1/27	1/31/27	2/1/27	$	21,840,986.42	5.50%	9.75%	$	180,861.32		--	$	180,861.32	$	3,120,140.92	$	3,301,002.24	--	$	18,720,845.50
55	2/1/27	2/28/27	3/1/27	$	18,720,845.50	5.50%	9.75%	$	140,021.67		--	$	140,021.67	$	3,120,140.92	$	3,260,162.58	--	$	15,600,704.58
56	3/1/27	3/31/27	4/1/27	$	15,600,704.58	5.50%	9.75%	$	129,186.66		--	$	129,186.66	$	3,120,140.92	$	3,249,327.57	--	$	12,480,563.67
57	4/1/27	4/30/27	5/1/27	$	12,480,563.67	5.50%	9.75%	$	100,015.48		--	$	100,015.48	$	3,120,140.92	$	3,220,156.39	--	$	9,360,422.75
58	5/1/27	5/31/27	6/1/27	$	9,360,422.75	5.50%	9.75%	$	77,511.99		--	$	77,511.99	$	3,120,140.92	$	3,197,652.91	--	$	6,240,281.83
59	6/1/27	6/30/27	7/1/27	$	6,240,281.83	5.50%	9.75%	$	50,007.74		--	$	50,007.74	$	3,120,140.92	$	3,170,148.65	--	$	3,120,140.92
60	7/1/27	8/2/27	8/2/27	$	3,120,140.92	5.50%	9.75%	$	27,504.26		--	$	27,504.26	$	3,120,140.92	$	3,147,645.17	--	$	0.00

Exhibit 4.16

CERTAIN INFORMATION (INDICATED BY ASTERISKS) HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED.

ASSET PURCHASE AGREEMENT

between

GENOMIC HEALTH, INC.

and

MDXHEALTH SA

dated as of

August 2, 2022

ASSET PURCHASE AGREEMENT

This Asset Purchase Agreement (this “Agreement”), dated as of August 2, 2022, is entered into between Genomic Health, Inc., a Delaware corporation (“Seller”), and MDxHealth SA, a limited liability company (société anonyme) organized and existing under the laws of Belgium (“Buyer”).

RECITALS

WHEREAS, Seller is engaged, through its urology diagnostics division, in the business of developing, marketing and performing the Oncotype DX Genomic Prostate Score test (the “GPSTest” and such business, the “Business”); and

WHEREAS, Seller wishes to sell and assign to Buyer, and Buyer wishes to purchase and assume from Seller, the Purchased Assets (as defined herein) and the Assumed Liabilities (as defined herein) related to the Business, subject to the terms and conditions set forth herein.

NOW, THEREFORE, in consideration of the mutual covenants and agreements hereinafter set forth and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto agree as follows:

Article I

DEFINITIONS

The following terms have the meanings specified or referred to in this ARTICLE I:

“2023 Business Revenue” means the aggregate revenue recognized by Buyer and derived from the Business for the 2023 Earn-Out Period, calculated in accordance with the Accounting Principles.

“2023 Earn-Out Amount” has the meaning set forth in Section 2.07(a)(i).

“2023 Earn-Out Period” means the period beginning January 1, 2023 and ending December 31, 2023.

“2023 Threshold” has the meaning set forth in Section 2.07(a)(i).

“2024 Business Revenue” means the aggregate revenue recognized by Buyer and derived from the Business for the 2024 Earn-Out Period, calculated in accordance with the Accounting Principles.

“2024 Earn-Out Amount” has the meaning set forth in Section 2.07(a)(ii).

“2024 Earn-Out Period” means the period beginning January 1, 2024 and ending December 31, 2024.

“2024 Threshold” has the meaning set forth in Section 2.07(a)(ii).

“2025 Business Revenue” means the aggregate revenue recognized by Buyer and derived from the Business for the 2025 Earn-Out Period, calculated in accordance with the Accounting Principles.

“2025 Earn-Out Amount” has the meaning set forth in Section 2.07(a)(iii).

“2025 Earn-Out Period” means the period beginning January 1, 2025 and ending December 31, 2025.

“2025 Threshold” has the meaning set forth in Section 2.07(a)(iii).

“30% Reference Lab Limitation” has the meaning set forth in Section 5.09.

“Accession Date” means the date on which the applicable order was received by Seller.

“Accounting Principles” means IFRS and the financial reporting standards in which Buyer prepares its periodic financial statements applying the same principles, practices, procedures, policies and methods as used by the Buyer on a consistent basis.

“Action” means any claim, action, cause of action, demand, lawsuit, arbitration, inquiry, audit, notice of violation, proceeding, litigation, citation, summons, subpoena or investigation of any nature, civil, criminal, administrative, regulatory or otherwise, whether at law or in equity, by or before any Governmental Authority, arbitrator or mediator.

“Affiliate” of a Person means any other Person that directly or indirectly, through one or more intermediaries, controls, is controlled by, or is under common control with, such Person. The term “control” (including the terms “controlled by” and “under common control with”) means the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of a Person, whether through the ownership of voting securities, by contract or otherwise.

“Agreement” has the meaning set forth in the preamble.

“Allocation Schedule” has the meaning set forth in Section 2.08.

“Annual Business Revenue” means, as applicable, each of the 2023 Business Revenue, the 2024 Business Revenue and/or the 2025 Business Revenue.

“Annual Earn-Out Amount” means, as applicable, each of the 2023 Earn-Out Amount, the 2024 Earn-Out Amount, and / or the 2025 Earn-Out Amount.

“Annual Financial Report” means a financial report setting forth the revenues, cost of goods and operating expenses (with individual line items breaking out selling expenses, marketing expenses, medical affairs, health systems and research & development) of the Business as of and for the years ending December 31, 2021 and 2020.

“Assigned Contracts” has the meaning set forth in Section 2.01(c).

“Assignment and Assumption Agreement” has the meaning set forth in Section 3.02(a)(ii).

“Assumed Liabilities” has the meaning set forth in Section 2.03.

“Benefit Plan” has the meaning set forth in Section 4.14(a).

“Bill of Sale” has the meaning set forth in Section 3.02(a)(i).

“Books and Records” means all books, records, files, documents, data, information and correspondence, including, but not limited to, books of account, ledgers and general, financial and accounting records, machinery and equipment maintenance files, pre-clinical, clinical and process development data and reports relating to research or development of products or of any materials used in the research, development, manufacture, marketing or sale of products, including all raw data relating to clinical trials of assays, services or products, all case report forms relating thereto, specifications, formulations, engineering and other manuals and drawings, standard operating procedures, algorithms, formulae, flow diagrams, historical testing data, laboratory notebooks, customer lists, customer purchasing histories, price lists, distribution lists, supplier lists (including all records with respect to supply sources), production data, quality control records and procedures, customer complaints and inquiry files, research and development files, records and data (including all correspondence with any Governmental Authority), sales material and records (including pricing history, total sales, terms and conditions of sale, sales and pricing policies and practices), and internal financial statements, provided, however, that Tax Returns (and related work papers), payor contracts and pricing applicable to such payors, and personnel records relating to the Business Employees or Transfer Employees shall be excluded from the definition of Books and Records.

“Business” has the meaning set forth in the recitals.

“Business Books and Records” has the meaning set forth in Section 2.01(f).

“Business Day” means any day except Saturday, Sunday or any other day on which commercial banks located in New York, New York, San Francisco, California, or Brussels, Belgium are authorized or required by Law to be closed for business.

“Business Employees” has the meaning set forth in Section 4.13(b).

“Business Intellectual PropertyAgreements” means all licenses, sublicenses, consent to use agreements, settlements, coexistence agreements, covenants not to sue, waivers, releases, permissions and other Contracts, whether written or oral, relating to any Intellectual Property that is used or held for use, in either case, exclusively in, or reasonably necessary for, the conduct of the Business as currently conducted to which Seller or any of its Affiliates is a party, other than commercially available off-the-shelf software licensed by Seller for its internal use.

“Business Intellectual Property Assets” means all Intellectual Property that is owned by Seller and used or held for use, in either case, either exclusively in, or reasonably necessary for, the conduct of the Business as currently conducted, including the Intellectual Property set forth in Section 2.01(b) of the Disclosure Schedules, together with all (i) royalties, fees, income, payments, and other proceeds now or hereafter due or payable to Seller with respect to such Intellectual Property; and (ii) claims and causes of action with respect to such Intellectual Property, including all rights to and claims for damages, restitution, and injunctive and other legal or equitable relief for infringement, misappropriation, or other violation thereof.

“Business Intellectual Property Assignments” has the meaning set forth in Section 3.02(a)(iii).

“Business Intellectual Property Registrations” means all Business Intellectual Property Assets that are subject to any issuance, registration, or application by or with any Governmental Authority or authorized private registrar in any jurisdiction, including issued Patents, registered Trademarks, domain names and Copyrights, and pending applications for any of the foregoing.

“Business Service Providers” has the meaning set forth in Section 4.13(a). “Buyer” has the meaning set forth in the preamble.

“Buyer ADS” means an American Depository Share of Buyer representing 10 Buyer Ordinary Shares.

“Buyer ADS Agreed Value” means the volume-weighted average closing price of ten (10) Buyer Ordinary Shares, as reported on Euronext Brussels, for the twenty (20) trading days ending on the final trading day of the 2023 Earn-Out Period, the 2024 Earn-Out Period or 2025 Earn-Out Period, as applicable.

“Buyer Indemnitees” has the meaning set forth in Section 8.02.

“Buyer Ordinary Shares” means the ordinary shares of no nominal value of Buyer.

“Buyer Plan” has the meaning set forth in Section 6.05(g).

“Claiming Party” has meaning set forth in Section 10.11(b).

“Closing” has the meaning set forth in Section 3.01.

“Closing Cash Consideration” has the meaning set forth in Section 2.06(a).

“Closing Consideration” has the meaning set forth in Section 2.06(a).

“Closing Date” has the meaning set forth in Section 3.01.

“Closing Equity Consideration” has the meaning set forth in Section 2.06(a).

“CMS” means the Centers for Medicare and Medicaid Services of the United States Department of Health and Human Services.

“COBRA” means the requirements of Part 6 of Subtitle B of Title I of ERISA and Section 4980B of the Code and of any similar state law.

“Code” means the Internal Revenue Code of 1986, as amended.

“Contracts” means all contracts, leases, deeds, mortgages, licenses, instruments, notes, commitments, undertakings, indentures, joint ventures and all other agreements, commitments and legally binding arrangements, whether written or oral.

“Contribution Confirmation” has the meaning set forth in Section 3.02(a)(xii).

“Contribution of the Closing ADS Payable” has the meaning set forth in Section 2.06(a).

“Contribution of the Earn-Out ADS Payable” has the meaning set forth in Section 2.07(c)(iii).

“COVID-19” means, generally, the novel coronavirus commonly referred to as COVID-19 (and all derivations or mutations thereof).

“Defending Party” has meaning set forth in Section 10.11(b).

“Direct Claim” has the meaning set forth in Section 8.05(c).

“Disclosure Schedules” means the Disclosure Schedules delivered by Seller and Buyer concurrently with the execution and delivery of this Agreement.

“Dollars”, “dollars” or “$” means the lawful currency of the United States.

“Earn-Out ADS Payable” has the meaning set forth in Section 2.07(c)(iii).

“Earn-Out Calculation” has the meaning set forth in Section 2.07(b)(i).

“Earn-Out Calculation Delivery Date” has the meaning set forth in Section 2.07(b)(i).

“Earn-Out Calculation Objection Notice” has the meaning set forth in Section 2.07(b)(ii).

“Earn-Out Calculation Statement” has the meaning set forth in Section 2.07(b)(i).

“Earn-Out Consideration Due Date” has the meaning set forth in Section 2.07(c)(i).

“Earn-Out Periods” means each of the 2023 Earn-Out Period, the 2024 Earn-Out Period, and the 2025 Earn-Out Period.

“Employee Leasing Agreement” has the meaning set forth in Section 3.02(a)(vii).

“Employment Commencement Date” has the meaning set forth in Section 6.05(a).

“Encumbrance” means any charge, community property interest, pledge, condition, equitable interest, lien (statutory or other), option, security interest, mortgage, deed of trust, easement, encroachment, right of way, right of first refusal, or restriction on transfer or exception to or defect in title. For the avoidance of doubt, “Encumbrance” shall not be deemed to include any license of Intellectual Property.

“ERISA” means the Employee Retirement Income Security Act of 1974, as amended, and the regulations promulgated thereunder.

“ERISA Affiliate” means all employers (whether or not incorporated) that would be treated together with the Seller as a “single employer” within the meaning of Section 414 of the Code or Section 4001 of ERISA.

“Enforceability Exceptions” has the meaning set forth in Section 4.02.

“Exchange Rate” has the meaning set forth in Section 2.06(b).

“Excluded Assets” has the meaning set forth in Section 2.02.

“Excluded Contracts” has the meaning set forth in Section 2.02(d).

“Excluded Liabilities” has the meaning set forth in Section 2.04.

“FDA” means the United States Food and Drug Administration.

“Federal Healthcare Program” means any “federal health care program” as defined in 42 U.S.C 1320a-7b(f), including Medicare, state Medicaid, state CHIP programs, TRICARE and similar or successor programs with or for the benefit of any government authority.

“Financial Reports” has the meaning set forth in Section 4.04.

“Force Majeure Event” means a(n) (a) act of God; (b) flood, fire, earthquake, pandemic, epidemic or explosion; (c) war, invasion, hostilities (whether war is declared or not), terrorist threats or acts, riot or other civil unrest; (d) obligation to comply with a Governmental Order or Law; (e) embargoes or blockades; (f) national or regional emergency; (g) strikes, labor shortages, stoppages or slowdowns, or other industrial disturbances; (h) telecommunication breakdowns, power outages or shortages, lack of warehouse or storage space, inadequate transportation services, or inability or delay in obtaining sufficient supplies of adequate or suitable materials; and (i) other similar events.

“GAAP” means United States generally accepted accounting principles in effect from time to time, consistently applied.

“Government Contracts” has the meaning set forth in Section 4.06(a)(iv).

“Governmental Authority” means any federal, state, local or foreign government or political subdivision thereof, or any agency of such government or political subdivision, any Medicare Administrative Contractor, or any self-regulated organization or other non-governmental regulatory authority or quasi-governmental authority (to the extent that the rules, regulations or orders of such organization or authority have the force of Law), or any arbitrator, court or tribunal of competent jurisdiction.

“Governmental Order” means any order, writ, judgment, injunction, decree, stipulation, determination or award entered by or with any Governmental Authority.

“GPS Test” has the meaning set forth in the recitals.

“GPS Trade Secrets” has the meaning set forth in Section 6.18(a)(i).

“Healthcare Regulatory Laws” means: (i) all healthcare fraud and abuse Laws, including: (A) the Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b), 42 C.F.R. § 1001.952, (B) the Civil Monetary Penalties Law, 42 U.S.C. § 1320a-7a, (C) the federal physician self-referral prohibition, 42 U.S.C. § 1395nn, 42 C.F.R. § 411.351 et seq., and (D) the False Claims Act, 31 U.S.C. § 3729 et seq.; (ii) the Food Drug and Cosmetic Act, 21 U.S.C. § 301 et seq.; (iii) Laws relating to billing or claims for reimbursement submitted to any Third Party Payor; (iv) HIPAA, the regulations promulgated pursuant thereto and comparable state privacy and security Laws and regulations; (v) the Clinical Laboratory Improvement Amendments of 1988, 42 U.S.C. § 263a; (vi) all state Laws governing the licensure and operation of clinical laboratories; and (vii) all Laws applicable to enrollment and participation in Federal Healthcare Programs.

“HIPAA” means the Health Insurance Portability and Accountability Act of 1996, Pub. L. No. 104-191, as amended by the Health Information Technology for Economic and Clinical Health Act (including the Standards of Privacy of Individual Identifiable Health Information (45 C.F.R Part 164, Subparts A and E), and the Security Standards for the Protection of Electronic Protected Health Information (45 C.F.R. Part 164, Subparts A and C) promulgated thereunder).

“HSR Act” means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.

“IFRS” means the International Financials Reporting Standards as issued by the International Accounting Standards Board, consistently applied.

“Indemnified Party” has the meaning set forth in Section 8.05.

“Indemnifying Party” has the meaning set forth in Section 8.05.

“Independent Accountant” has the meaning set forth in Section 2.07(b)(ii).

“Intellectual Property” means: (a) issued patents and patent applications (whether provisional or non-provisional), including divisionals, continuations, continuations-in-part, substitutions, reissues, reexaminations, extensions, or restorations of any of the foregoing (“Patents”); (b) trademarks, service marks, brands, certification marks, logos, trade dress, trade names, and other similar indicia of source or origin, together with the goodwill connected with the use of and symbolized by, and all registrations, applications for registration, and renewals of, any of the foregoing (“Trademarks”); (c) copyrights and works of authorship, whether or not copyrightable, and all registrations, applications for registration, and renewals of any of the foregoing (“Copyrights”); (d) internet domain names and social media account or user names (including “handles”), whether or not Trademarks, all associated web addresses, URLs, websites and web pages, social media sites and pages, and all content and data thereon or relating thereto, whether or not Copyrights; (e) mask works, and all registrations, applications for registration, and renewals thereof; (f) industrial designs, and all Patents, registrations, applications for registration, and renewals thereof; (g) trade secrets, know-how, inventions (whether or not patentable), discoveries, improvements, technology, business and technical information, databases, data files, data compilations and collections, tools, methods, processes, techniques, and other confidential and proprietary information and all rights therein (“TradeSecrets”); (h) rights of publicity; and (i) all other intellectual property rights.

“Interim Financial Report” means a report setting forth the revenues, cost of goods or operating expenses (with individual line items breaking out selling expenses, marketing expenses, medical affairs, health systems and research & development) of the Business as of and for the six months ending June 30, 2022.

“Inventory” means inventories used or intended for use in the Business, including assays, reagents and other materials.

“Knowledge of Seller” or “Seller’sKnowledge” means the actual knowledge of Rick Baehner, Irene Chen, Srini Kodali, Jennifer Duke or Lee Anderson and such knowledge that would have been obtained by such persons from reasonable inquiry of the persons directly reporting to such individuals with responsibility for the subject matter in question.

“Later-Disclosed Trade Secrets” means Trade Secrets that cannot, in their present form, be disclosed without also disclosing Non-GPS Trade Secrets.

“Law” means any applicable statute, law, ordinance, regulation, rule, code, order, constitution, treaty, common law, judgment, decree, or Governmental Order of any Governmental Authority, and includes any Healthcare Regulatory Laws.

“Leased Employees” has the meaning set forth in Section 6.05(a).

“Leasing Period” has the meaning set forth in Section 6.05(a).

“Liabilities” means liabilities, obligations or commitments of any nature whatsoever, asserted or unasserted, known or unknown, absolute or contingent, accrued or unaccrued, matured or unmatured or otherwise.

“Licensed Business Intellectual Property” means all Intellectual Property in which Seller holds any rights or interests granted by other Persons that is used or held for use in the conduct of the Business as currently conducted.

“Losses” means losses, damages, liabilities, deficiencies, Actions, judgments, interest, awards, penalties, fines, costs or expenses of whatever kind, including reasonable attorneys’ fees and the cost of enforcing any right to indemnification hereunder; provided, however, that “Losses” shall not include any punitive damages, except to the extent actually awarded to a Governmental Authority or other third party in a Third Party Claim.

“Material Adverse Effect” means any event, occurrence, fact, condition or change that is materially adverse to the Business, results of its operations, its condition (financial or otherwise) or the Purchased Assets; provided, however, that “Material Adverse Effect” shall not include any event, occurrence, fact, condition or change, directly or indirectly, arising out of or attributable to: (i) general economic or political conditions; (ii) conditions generally affecting the industries in which the Business operates; (iii) any changes in financial or securities markets in general; (iv) acts of war (whether or not declared), armed hostilities or terrorism, or the escalation or worsening thereof; (v) any failure by the Seller or the Business to meet internal or published projections or forecasts or third party revenue or earnings predictions or forecasts; (vi) any natural disaster, any public health event (including any epidemic, pandemic, or disease outbreak (including the COVID-19 virus)) or any acts of terrorism, sabotage, military action or war (whether or not declared) or any escalation or worsening thereof; or (vii) any changes in applicable Laws or accounting rules, including GAAP or IFRS; provided further, however, that in the case of clauses (i), (ii), (iii), (iv), (vi) and (vii) immediately above only to the extent that such event, occurrence, fact, condition or change does not have a materially disproportionate effect on the Business compared to other participants in the industries in which the Business operates.

“Material Contracts” has the meaning set forth in Section 4.06(a).

“Material Payors” means, for the applicable fiscal year, the top twenty (20) payors of the Business, based on the test volume generated from such payor.

“Material Suppliers” means, for the applicable fiscal year, the top ten (10) suppliers of the business unit of Seller in which the Business operates, based on the dollar amount of purchases by the Seller from the supplier.

“Medicare Administrative Contractor” has the meaning set forth in Section 911(a) of the Medicare Prescription Drug Improvement, and Modernization Act of 2003, as amended.

“Non-GPS Trade Secret” means Trade Secrets of Seller or its Affiliates that are not (x) exclusive to the Business or (y) reasonably necessary for the proper and accurate manufacturing and/or performance of the GPS Test.

“Permits” means all permits, licenses, approvals, authorizations, registrations, certificates, and similar rights required to be obtained from Governmental Authorities in connection with the development, marketing or performance of the GPS Test.

“Permitted Encumbrances” means the following: (a) statutory liens for current Taxes, assessments and governmental charges not yet due or payable; (b) rights reserved to any Governmental Authority to regulate the affected asset or property and all Laws applicable to the assets or properties; (c) liens granted to any lender at the Closing in connection with any financing by Buyer of the transactions contemplated hereby; (d) Encumbrances that will be released prior to or as of the Closing Date; and (e) those Encumbrances described as “Permitted Encumbrances” in Section 4.07 of the Disclosure Schedules.

“Person” means an individual, corporation, partnership, joint venture, limited liability company, Governmental Authority, unincorporated organization, trust, association or other entity.

“Pre-Closing Tax Period” means any taxable period ending on or before the Closing Date and, with respect to any taxable period that includes (but does not end on) the Closing Date, the portion of such taxable period ending on and including the Closing Date.

“Purchase Price” has the meaning set forth in Section 2.05.

“Purchased Assets” has the meaning set forth in Section 2.01.

“Qualified Benefit Plan” has the meaning set forth in Section 4.14(c).

“R&W Insurance Policy” means the representations and warranties insurance policy issued by Travelers Excess and Surplus Lines Company to Buyer as of the Closing Date.

“Reference Laboratory Services Agreement” has the meaning set forth in Section 3.02(a)(vi).

“Representative” means, with respect to any Person, any and all directors, officers, employees, consultants, financial advisors, counsel, accountants and other agents of such Person.

“Restricted Business” means the marketing or performing of any in vitro test with one or more of the following clinical indications for use: the assessment of prostate cancer severity or prognosis for patients with localized prostate cancer, or informing the initial treatment modality (i.e., surveillance vs definitive treatment) and/or intensity of the treatment (e.g., radiation or androgen deprivation therapy following prostatectomy). For the avoidance of doubt, “Restricted Business” does not include cell-free DNA-based tests performed after initial or definitive treatment to detect residual disease and/or disease recurrence which may also inform therapeutic choice and/or provide prognostic value.

“Restricted Period” has the meaning set forth in Section 6.07(a).

“Review Period” has the meaning set forth in Section 2.07(b)(ii).

“Seller” has the meaning set forth in the preamble.

“Seller Fundamental Representations” means the representations and warranties of Seller contained in Section 4.01 (Organization and Qualification of Seller), Section 4.02 (Authority of Seller), Section 4.07 (Title to Purchased Assets) and Section 4.16 (Brokers).

“Seller Indemnitees” has the meaning set forth in Section 8.04.

“Taxes” means any and all U.S. or non-U.S. federal, provincial, state or local taxes, and similar charges, fees, levies, imposts, duties and other similar assessments or charges of any kind whatsoever, imposed by any taxing authority, including ad valorem taxes, add-on minimum taxes, alternative minimum taxes, capital taxes, customs duties, employment taxes, environmental taxes, estimated taxes, excise taxes, franchise taxes, goods and services taxes, gross receipts taxes, imputed underpayments, income taxes (whether imposed on or measured by net income, gross income, income as specially defined, earnings, profits or selected items of income, earnings or profits), license taxes, net worth taxes, occupation taxes, payroll taxes, premium taxes, property taxes, recording taxes, retirement taxes, sales taxes, services taxes, severance taxes, social security premiums, stamp taxes, transfer taxes, unemployment taxes, use taxes, value-added taxes, windfall profits taxes, withholding taxes or other withholding obligations, together with all interest, penalties, fines, additions to tax imposed with respect to the foregoing or other amounts imposed with respect to the foregoing.

“Tax Return” means any return, declaration, report, claim for refund, estimate, election, information return or statement or other document relating to Taxes, including any schedule or attachment thereto, and including any amendment thereof.

“Territory” means the jurisdictions in which the Business operates as of the Closing Date.

“Third Party Claim” has the meaning set forth in Section 8.05(a).

“Third Party Payors” means all Federal Health Care Programs and all other state or local governmental insurance programs and private, non-governmental insurance and managed care programs with which Seller contracts to provide goods and services or through which the Seller receives payments or reimbursements for goods and services provided related to the Business.

“Trademark Licensing Agreement” has the meaning set forth in Section 3.02(a)(iv).

“Transfer Employees” has the meaning set forth in Section 6.05(a).

“Transition Services Agreement” has the meaning set forth in Section 3.02(a)(v).

“VA” means the United States Department of Veterans Affairs.

“VA Arrangement” has the meaning set forth in Section 6.20.

“VA License Agreement” has the meaning set forth in Section 3.02(a)(viii).

“WARN Act” means the federal Worker Adjustment and Retraining Notification Act of 1988, and similar state, local and foreign laws related to plant closings, relocations, mass layoffs and employment losses.

Article II

PURCHASE AND SALE

Section 2.01 Purchase and Sale of Assets. Subject to the terms and conditions set forth herein, at the Closing, Seller shall sell, assign, transfer, convey and (except as otherwise permitted by Section 6.18(a)) deliver to Buyer, and Buyer shall purchase from Seller, free and clear of any Encumbrances other than Permitted Encumbrances, all of Seller’s right, title and interest in, to and under the following (collectively, the “Purchased Assets”):

(a) [Intentionally Omitted];

(b) all Business Intellectual Property Assets, including all GPS Trade Secrets and Later-Disclosed Trade Secrets included in the Business Intellectual Property Assets;

(d) [Intentionally omitted];

(e) Seller’s rights under warranties, indemnities and all similar rights against third parties to the extent related exclusively to any Purchased Assets or the Assumed Liabilities;

(f) originals, or where not available, copies, of the Books and Records relating to the Business (which may be redacted or extracted to remove information unrelated to the Business), including, without limitation those Books and Records listed in Section 2.01(f) of the Disclosure Schedules (“Business Books and Records”) including Business Books and Records that include Later-Disclosed Trade Secrets (“Later-Disclosed Business Books and Records”) and GPS Trade Secrets; and

(g) the goodwill and the going concern value of the Business.

Section 2.02 Excluded Assets. Notwithstanding the foregoing, the Buyer expressly understands and agrees that it is not purchasing or otherwise acquiring from Seller or any of its Affiliates any assets, properties, or rights of every kind or nature, whether real, personal or mixed, tangible or intangible, whether now existing or hereafter acquired other than the Purchased Assets set forth in Section 2.01, including without limitation, the following (collectively, the “Excluded Assets”):

(a) all assets, properties, and rights that are not Purchased Assets;

(b) all Intellectual Property other than the Business Intellectual Property Assets;

(c) all cash, cash equivalents, short-term investments, bank accounts, trade and other accounts receivable or similar rights to receive payments accruing to Seller and related to the operation of the Business prior to the Closing Date, whether billed or unbilled, provided,however, that payments attributable to the performance of a GPS Test shall be deemed to be accrued to Seller prior to the Closing Date if the Accession Date for the sample for that GPS Test is prior to the Closing Date;

(d) all Contracts, including Business Intellectual Property Agreements, that are not Assigned Contracts (the “Excluded Contracts”);

(e) all corporate seals, organizational documents, minute books, stock books, Tax Returns and work papers related thereto, books of account or other records having to do with the corporate organization of Seller;

(f) all rights or claims of the Seller or any of its Affiliates with respect to any Tax refund, deposit, estimated payment, carryback or carryforward or other credits to the Seller or claims of any of their Affiliates for Pre-Closing Tax Periods;

(g) all Books and Records, other than the Business Books and Records;

(h) all Tax Returns of Seller or any Affiliate of Seller;

(i) (i) all personnel records relating to the Business Employees or Transfer Employees;

(j) all Benefit Plans and assets attributable thereto;

(k) all claims, causes of action, suits, judgments, demands or rights of any nature against other persons related to any Excluded Asset or any Excluded Liability and all attorney-client, work product and other legal privileges of Seller or any Affiliate related thereto;

(l) any goodwill and going value concern not associated exclusively with the Business; and

(m) all rights which accrue or will accrue to Seller under this Agreement and the Ancillary Documents.

Section 2.03 Assumed Liabilities. Subject to the terms and conditions set forth herein, Buyer shall assume and agree to timely pay, perform, discharge and otherwise satisfy when due only the following Liabilities of Seller (collectively, the “Assumed Liabilities”) and no other liabilities:

(a) all Liabilities in respect of the Assigned Contracts and transferred Permits but only to the extent that such Liabilities thereunder are required to be performed after the Closing Date, were incurred in the ordinary course of business and do not relate to any failure to perform, improper performance, warranty or other breach, default or violation by Seller on or prior to the Closing; and

(b) the transfer taxes that are allocable to Buyer pursuant to Section 6.14.

Section 2.04 ExcludedLiabilities. Notwithstanding the provisions of Section 2.03 or any other provision in this Agreement to the contrary, Buyer shall not assume and shall not be responsible to pay, perform or discharge the following Liabilities of Seller (the “Excluded Liabilities”), which Seller shall, or shall cause each of its Affiliates to, pay and satisfy in due course all Excluded Liabilities which they are obligated to pay and satisfy. Without limiting the generality of the foregoing, the Excluded Liabilities shall include, but not be limited to, the following:

(a) any Liability for (i) any Taxes of Seller (or any stockholder or Affiliate of Seller); (ii) any Taxes relating to the operation of the Business or the ownership, possession or use of the Purchased Assets; or (iii) the transfer taxes that are allocable to Seller pursuant to Section 6.14; in each case, to the extent arising out of any Pre-Closing Tax Period;

(b) any Liabilities relating to or arising out of the Excluded Assets;

(d) any Liabilities in respect of any Action arising out of, relating to or otherwise in respect of the operation of the Business or the Purchased Assets to the extent such Action relates to such operation on or prior to the Closing Date;

(e) any Liabilities of Seller for any present or former employees, officers, directors, retirees, independent contractors or consultants of Seller, including, without limitation, any Liabilities accruing or arising before Closing associated with any claims for wages or other benefits, bonuses, accrued vacation, workers’ compensation, severance, retention, termination or other payments;

(f) any Liabilities arising out of any Contracts, including Business Intellectual Property Agreements, (i) which are not validly and effectively assigned to Buyer pursuant to this Agreement; (ii) which do not conform to the representations and warranties with respect thereto contained in this Agreement; or (iii) to the extent such Liabilities arise out of or relate to a breach by Seller of such Contracts prior to Closing; and

(g) any Liabilities arising out of, in respect of or in connection with the failure by Seller to comply with any Law or Governmental Order prior to Closing.

Section 2.05 Purchase Price. The aggregate consideration for the Purchased Assets (the “Purchase Price”) shall be comprised of (a) the Closing Consideration, (b) the Earn-Out Consideration and (c) the assumption of the Assumed Liabilities.

Section 2.06 Closing Consideration.

(a) The consideration for the Purchased Assets shall be comprised of (a) an amount of $24,999,999.64 payable at Closing as provided in Section 3.02 (the “Closing Cash Consideration”), and (b) an amount of $5,000,000.36 (the “Closing ADS Payable”), which shall not be paid in cash but shall remain outstanding as a payable (without accruing interest) due by Buyer as from Closing, but which payable shall be contributed in kind by Seller to Buyer within the context of a capital increase by Buyer within the framework of the authorised capital of Buyer (the “Contribution of the Closing ADS Payable”) against the issuance by Buyer of 6,911,717 new Buyer Ordinary Shares, which shall be delivered in the form of 691,171 Buyer ADSs (the “Closing Equity Consideration” and, together with the Closing Cash Consideration, the “Closing Consideration”).

(b) For the purpose of Contribution of the Closing ADS Payable, the amount of the Closing ADS Payable shall be converted into euro on the basis of the relevant USD/EUR exchange ratio as shall be published by the European Central Bank (“ECB”) on https://www.ecb.europa.eu/stats/policy_and_exchange_rates/euro_reference_exchange_rates/htm l/index.en.html (or such other relevant website of the ECB) (the “Exchange Rate”) on the Business Day preceding the date of the relevant notarial deed in which the issuance of the relevant Buyer Ordinary Shares underlying the Buyer ADSs and the corresponding capital increase are established, and whereby final amount in euro will be rounded down to the nearest two decimals. Provided that Seller has delivered an executed Contribution Confirmation as contemplated by Section 3.02(a)(xii) on the Closing Date, the Buyer Ordinary Shares shall be issued and the Buyer ADSs shall be delivered to the Seller no later than fifteen (15) days after the Closing Date.

(c) All of the Buyer ADSs or Buyer Ordinary Shares to be issued for delivery pursuant to this Agreement to the Seller as Closing Equity Consideration will have the same rights and benefits as, and rank pari passu in all respects, including as to entitlement to dividends and distributions, with, the existing and outstanding Buyer ADSs or Buyer Ordinary Shares at the moment of their issuance and will be entitled to dividends and distributions in respect of which the relevant record date or due date falls on or after the date of issuance of the Buyer ADSs or Buyer Ordinary Shares.

(d) If, at any time as from the Closing Date at which there is an outstanding Closing ADS Payable until the delivery of the Buyer ADSs or Buyer Ordinary Shares to the Seller in accordance with this Agreement, the holders of Buyer ADSs or Buyer Ordinary Shares shall have received, without payment therefor, stock or other securities or property (including cash) in respect of such of Buyer ADSs or Buyer Ordinary Shares (including by way of combinations, reorganizations, reclassifications, mergers, acquisitions or similar events but excluding any dividends) pursuant to an event, declaration, decision or distribution which has taken place or been adopted after the Closing Date but before the delivery of the Buyer ADSs or Buyer Ordinary Shares to the Seller in accordance with this Agreement, then and in each such case, the Seller shall be entitled to receive, at such time as the Closing ADS Payable would otherwise be required to be delivered to Seller hereunder, the amount of stock or other securities or property (including cash) which Seller would be entitled had it been issued the Closing ADS Payable as of the date on which holders of Buyer ADSs or Buyer Ordinary Shares received such stock or other securities or property (including cash).

(e) Notwithstanding anything to the contrary herein or in any other of the Ancillary Documents, in no event shall the number of Buyer Ordinary Shares underlying the Buyer ADSs comprising the Closing Equity Consideration exceed five percent (5%) of the total number of Buyer Ordinary Shares outstanding immediately prior to the Closing.

(f) All fees and expenses incurred by in connection with the performance of Buyer’s obligations under or in compliance with this Section 2.06 shall be borne by Buyer.

Section 2.07 Earn-Out Consideration.

(a) Annual Earn-Out Amounts. In accordance with and subject to the terms and conditions set forth in this Section 2.07, Seller may be entitled to additional amounts in consideration for the Purchased Assets (the “Earn-Out Consideration”).

(i) To the extent that 2023 Business Revenue is equal to or greater than $[***] (the “2023 Threshold”), Seller shall be entitled to consideration equal to [***] percent ([***]%) of the actual 2023 Business Revenue, up to a maximum earn-out amount of $30,000,000 (the amount actually earned, the “2023 Earn-OutAmount”). If the 2023 Business Revenue is less than the 2023 Threshold, the 2023 Earn-Out Amount shall be $0.

(ii) To the extent that 2024 Business Revenue is equal to or greater than $[***] (the “2024Threshold”), Seller shall be entitled to consideration equal to [***] percent ([***]%) of the 2024 Business Revenue up to a maximum earn-out amount of $40,000,000 (the amount actually earned, the “2024 Earn-Out Amount”). If the 2024 Business Revenue is less than the 2024 Threshold, the 2024 Earn-Out Amount shall be $0.

(iii) To the extent that 2025 Business Revenue is equal to or greater than $[***] (the “2025Threshold”), Seller shall be entitled to consideration equal to [***] percent ([***]%) of the 2025 Business Revenue, up to a maximum earn-out amount which, together with the 2023 Earn-Out Amount and the 2024 Earn-Out Amount, shall not, exceed, $70,000,000 in the aggregate (the “2025 Earn-Out Amount”).If the 2025 Business Revenue is less than the 2025 Threshold, the 2025 Earn-Out Amount shall be $0.

(b) Procedures for Determination of Annual Earn-Out Amounts.

(i) On or before the date which is 90 days after December 31 of each of calendar years 2023, 2024 and 2025 (each such date, an “Earn-OutCalculation Delivery Date”), Buyer shall prepare and deliver to Seller a written statement (in each case, an “Earn-OutCalculation Statement”) setting forth in reasonable detail its determination of the applicable Annual Business Revenue and its calculation of the resulting applicable Annual Earn-Out Amount (in each case, an “Earn-Out Calculation”).

(ii) Seller shall have, in its sole discretion, until the later of (A) 60 days after receipt of each Earn-Out Calculation Statement and (B) 30 days after Buyer’s audited financial statements are delivered to Seller or published for the calendar year to which the applicable Earn-Out Calculation Statement relates (in each case, the “Review Period”) to review the Earn-Out Calculation Statement and the Earn-Out Calculation set forth therein. During the Review Period, Seller and its accountants shall have the right, at Seller’s expense and subject to Sellers’ and its accountants’ execution and delivery of confidentiality agreements reasonably acceptable to Buyer, to inspect Buyer’s books and records solely for purposes reasonably related to the determination of the applicable Annual Earn-Out Amount. Seller’s review may be conducted remotely by the secure electronic or physical exchange of documents, as mutually agreed by Buyer and Seller in writing. Prior to the expiration of the Review Period, Seller may object to the Earn-Out Calculation set forth in the applicable Earn-Out Calculation Statement by delivering a written notice of objection (an “Earn-Out Calculation Objection Notice”) to Buyer. Any Earn-out Calculation Objection Notice shall specify the items in the applicable Earn-Out Calculation disputed by Seller and shall describe in reasonable detail the basis for such objection, as well as the amount in dispute. If Seller fails to deliver an Earn-Out Calculation Objection Notice to Buyer prior to the expiration of the applicable Review Period, then Seller shall be deemed to have accepted the Earn-Out Calculation set forth in the Earn-Out Calculation Statement delivered by Buyer. If Seller timely delivers an Earn-Out Calculation Objection Notice, Buyer and Seller shall negotiate in good faith using commercially reasonable efforts to resolve the disputed items and agree upon the applicable resulting Annual Earn-Out Amount. If Buyer and Seller are unable to reach agreement within 30 days after such an Earn-Out Calculation Objection Notice has been given (or such longer period as they may agree in writing), all unresolved disputed items shall be promptly referred to an impartial nationally recognized firm of independent certified public accountants appointed by mutual agreement of Buyer and Seller (the “Independent Accountant”). The Independent Accountant shall act as an accounting expert and not an arbitrator. Buyer and Seller shall direct the Independent Accountant to render a written report on only the unresolved disputed items with respect to the applicable Earn-Out Calculation as promptly as practicable, but in any event within 30 days of such submission to the Independent Accountant, and to resolve only those unresolved disputed items set forth in the Earn-Out Calculation Objection Notice. If unresolved disputed items are submitted to the Independent Accountant, Buyer and Seller shall each furnish to the Independent Accountant such work papers, schedules and other documents and information relating to the unresolved disputed items as the Independent Accountant may reasonably request. The Independent Accountant shall resolve the disputed items based solely on the applicable definitions and other terms in this Agreement and the written presentations by Buyer and Seller, and not by independent review. The Independent Accountant may not assign a value to any item greater than the greatest value for such item claimed by either Buyer or Seller or less than the smallest value for such item claimed by either Buyer or Seller. The resolution of the dispute and the calculation of the applicable Annual Earn-Out Amount that is the subject of the applicable Earn-Out Calculation Objection Notice by the Independent Accountant shall be set forth in a written statement and shall be final and binding on the parties hereto. The fees and expenses of the Independent Accountant shall be borne by Seller and Buyer in proportion to the amounts by which their respective calculations of the applicable Annual Earn-Out Amount differ from the Annual Earn-Out Amount as finally determined by the Independent Accountant.

(i) Any Annual Earn-Out Amount that Buyer is required to pay as Earn-Out Consideration pursuant to this Section 2.07 shall be paid in full no later (x) in the case of a payment of the applicable Earn-Out Amount in cash, ten (10) or, in case of a payment at the sole discretion of Buyer in Buyer ADSs, fifteen (15) Business Days following the date upon which the determination of such Annual Earn-Out Amount becomes final and binding upon the parties as provided in Section 2.07(b) (including any final resolution of any dispute raised by Seller in an Earn-Out Calculation Objection Notice) (such date the relevant “Earn-Out Consideration Due Date”).

(ii) Buyer may, in its sole discretion, pay to Seller the applicable Earn-Out Amount either in cash, by way of issuance or transfer of shares of Buyer ADSs and any combination of the foregoing, provided, however, that Buyer shall not issue Buyer ADSs to Seller in respect of an Earn-Out Amount if (i) the number of Buyer Ordinary Shares beneficially owned by Seller following such issuance would exceed five percent (5%) of the total number of outstanding Buyer Ordinary Shares immediately preceding such issuance or (ii) such issuance would require a filing pursuant to the HSR Act or the observance of a waiting period under the HSR Act or any other applicable antitrust Law. The value ascribed to the each of the Buyer ADSs shall be the Buyer ADS Agreed Value.

(iii) In the event Buyer elects to pay to Seller the applicable Earn-Out Amount (or a portion thereof) by way of Buyer ADSs, then the relevant amount of the Earn-Out Amount (or portion thereof) shall not be paid in cash but shall remain outstanding as a payable (without accruing interest) (the relevant “Earn-Out ADS Payable”) due by Buyer as from the relevant Earn-Out Consideration Due Date in relation to such Earn-Out Amount, and which payable shall need to be contributed in kind by Seller to Buyer within the context of a capital increase by Buyer within the framework of the authorised capital of Buyer (the “Contribution of the Earn-Out ADSPayable”) against the issuance by Buyer of the relevant number of new Buyer Ordinary Shares, which shall be delivered in the form of the relevant Buyer ADSs. For the purpose of Contribution of an Earn-Out ADS Payable, the amount of the relevant Earn-Out ADS Payable shall be converted into euro on the basis of the relevant Exchange Rate on the Business Day preceding the date of the relevant notarial deed in which the issuance of the relevant Buyer Ordinary Shares underlying the relevant Buyer ADSs and the corresponding capital increase are established, and whereby final amount in euro will be rounded down to the nearest two decimals. The issuance of the aforementioned Buyer Ordinary Shares shall be conditional upon Seller providing, at the written request of Buyer within seven (7) Business Days after the relevant Earn-Out Consideration Due Date, to Buyer an executed Contribution Confirmation no later than ten (10) Business Days after the relevant Earn-Out Consideration Due Date. Any portion of the relevant Earn-Out Amount that cannot be settled in a whole number of Buyer Ordinary Shares and a whole number of Buyer ADSs shall be settled in cash.

(iv) All of the Buyer ADSs or Buyer Ordinary Shares to be issued delivery pursuant to this Agreement to the Seller as Earn-Out Consideration will have the same rights and benefits as, and rank pari passu in all respects, including as to entitlement to dividends and distributions, with, the existing and outstanding Buyer ADSs or Buyer Ordinary Shares at the moment of their issuance and will be entitled to dividends and distributions in respect of which the relevant record date or due date falls on or after the date of issuance of the Buyer ADSs or Buyer Ordinary Shares. If, at any time as from the relevant Earn-Out Consideration Due Date at which there is an outstanding Earn-Out ADS Payable until the delivery of the Buyer ADSs or Buyer Ordinary Shares to the Seller in accordance with this Agreement, the holders of Buyer ADSs or Buyer Ordinary Shares shall have received, without payment therefor, stock or other securities or property (including cash) in respect of such of Buyer ADSs or Buyer Ordinary Shares (including by way of combinations, reorganizations, reclassifications, mergers, acquisitions or similar events but excluding any dividends) pursuant to an event, declaration, decision or distribution which has taken place or been adopted after the relevant Earn-Out Consideration Due Date but before the delivery of the relevant Buyer ADSs or Buyer Ordinary Shares to the Seller in accordance with this Agreement, then and in each such case, the Seller shall be entitled to receive, at such time as the Earn-Out ADS Payable would otherwise be required to be delivered to Seller hereunder, the amount of stock or other securities or property (including cash) which Seller would be entitled had it been issued the Earn-Out ADS Payable as of the date on which holders of Buyer ADSs or Buyer Ordinary Shares received such stock or other securities or property (including cash).

(v) Notwithstanding any other provision of this Agreement, the number of Buyer Ordinary Shares (including ADSs representing Buyer Ordinary Shares) that may be issued pursuant to this Agreement shall not, without the prior approval of the stockholders of Buyer, exceed the least of (a) 19.9% of the voting power of Buyer’s stockholders outstanding immediately before the date of this Agreement, (b) 19.9% of the number of Buyer Ordinary Shares (including ADSs representing Buyer Ordinary Shares) outstanding immediately before the date of this Agreement and (c) any other limit imposed by applicable rules of the Nasdaq Stock Market, Inc. (it being understood that any Earn-Out Consideration that is due and owing that cannot be paid in Buyer ADSs as a result of the foregoing limitation shall be paid in cash).

(vi) All fees and expenses incurred by Buyer in connection with its performance of its obligations under or in compliance with this Section 2.07(c) shall be borne by Buyer.

(d) Post-Closing Operation of the Business.

(i) Subject to the terms of this Agreement and the other Ancillary Documents, subsequent to the Closing, Buyer shall have sole discretion with regard to all matters relating to the operation of the Business; provided, that Buyer shall, and shall cause its Affiliates to, use commercially reasonable efforts to allow Seller to achieve the Earn-Out Consideration, and provided, further, that prior to the end of the 2025 Earn-Out Period, Buyer shall not, directly or indirectly:

(A) (1) take any action for the primary purpose of, and that would reasonably be expected to have the effect of, avoiding or reducing any Annual Earn-Out Amount or (2) omit to take any action for the primary purpose of, and that would reasonably be expected to have the effect of, avoiding or reducing any Annual Earn-Out Amount;

(B) operate the Business other than in the ordinary course of business (which shall not preclude commercially reasonable adaptation to a material change in business circumstances);

(C) enter into any transaction to perform the GPS Test that contains terms less favorable to the Buyer than those that would be obtained in an arm’s-length transaction; provided, however, that the provision of GPS Testing in the context of clinical trials, for evaluation purposes, for commercially reasonable market development activities, and in other limited scenarios consistent with prevailing industry practices, shall be excluded from this limitation;

(D) fail to maintain appropriate accounting Books and Records for the Business to the extent reasonably required to enable Seller to exercise its rights pursuant to Section 2.07(b)(ii);

(E) violate the 30% Reference Lab Limitation or refrain from referring orders or requests received for the performance of the GPS Test in order to comply with the 30% Reference Lab Limitation;

(F) sell the Business or any material assets comprising the Business or a controlling interest in the Business to any third party that does not assume Buyer’s obligations under this Section 2.07; provided, however, that a change in control of Buyer shall not be considered such a sale;

(G) take any action or omit to take any action that has the effect of the GPS Test not being added to Buyer’s Federal Supply Schedule or otherwise restricts Buyer from performing the GPS Test pursuant to orders and awards issued by the VA; or

(H) operate the Business other than in compliance with applicable Law in all material respects.

(ii) Notwithstanding anything herein to the contrary,

(A) if (x)(aa) the Buyer materially breaches any of its obligations under Section 2.07(d)(i)(A)(1) prior to the end of the 2025 Earn-Out Period, (bb) Seller notifies Buyer of such breach in writing within ten (10) days after an executive officer of Seller has actual knowledge of the facts constituting the breach, which notice describes such facts and such breach in reasonable detail, and (cc) Buyer fails to cure such breach within twenty (20) days after receipt of such notice, or (y) Buyer materially breaches any of its obligations under Section 2.07(d)(i)(E) prior to the end of the 2025 Earn-Out Period, then the Earn-Out Consideration payable to Seller for the Earn-Out Period in which such breach commenced (and, in the case of a breach that (1) is subject to a cure period under the foregoing clause (x) that extends into a new Earn-Out Period and (2) is not cured within such cure period, for that new Earn-Out Period) shall be deemed to equal the maximum amount of the Earn-Out Consideration achievable for such Earn-Out Period (but, for the avoidance of doubt, not an amount in excess of the applicable annual maximum earn-out limitation set forth in Section 2.07(a)). For avoidance of doubt, payment of any Earn-Out Consideration pursuant to this Section 2.07(d)(ii)(A) for any Earn-Out Period(s) shall be deemed to fulfill all of Buyer’s obligations under this Section 2.07 with respect to such Earn-Out Period(s) (regardless of any other breach of this Section 2.07);

(B) in the event Buyer breaches its obligations under Section 2.07(d)(i)(F), then Buyer shall promptly following the completion of such sale, pay to the Seller in immediately available funds the maximum amount of the Earn-Out Consideration achievable for all Earn-Out Periods ending on or after the date of such sale (to the extent not previously paid).

For avoidance of doubt, payment of the maximum amount of Earn-Out Consideration pursuant to this Section 2.07(d)(ii)(B) for any Earn-Out Period(s) shall be deemed to fulfill all of Buyer’s obligations under this Section 2.07 with respect to such Earn-Out Period(s) (regardless of any other breach of this Section 2.07); and

(C) Seller may pursue any non-equitable remedy available to Seller for any breach by Buyer of its obligations under Section 2.07(d)(i) with respect to an Earn-Out Period, unless the maximum Earn-Out Consideration that could be payable for such Earn-Out Period has been paid, in which case Seller shall have no further recourse under this Agreement for Buyer’s breach of Section 2.07(d)(i) for such Earn-Out Period.

(iii) During the Earn-Out Periods, as soon as available and in any event (A) within ten (10) days after the end of each quarter (or, during the term of the Reference Laboratory Services Agreement, Buyer’s receipt of all invoices from Seller for GPS Tests performed during such quarter), Buyer will deliver to Seller a report setting forth Buyer’s good faith estimates of (x) aggregate revenue expected to be recognized by Buyer and derived from the Business and (y) number of GPS Tests performed, in each case, for such quarter and for the period from the beginning of the then-current Earn-Out Period to the end of such quarter, and (B) within forty five (45) days after the end of each quarter, Buyer will deliver to Seller unaudited financial statements and reports prepared in accordance with the Accounting Principles showing Buyer’s activity and progress toward achievement of the Annual Business Revenue targets for such quarter and for the period from the beginning of the then current Earn-Out Period to the end of such quarter.

(iv) Notwithstanding the foregoing provisions of this Section 2.07(d), Seller acknowledges and agrees that any Earn-Out Consideration that may be payable pursuant to this Section 2.07 depends upon the performance of the Business and on factors outside the control of Buyer and that Buyer has not made and is not making any representations or warranties or other promises regarding the current or future performance of the Business and any such representations or warranties or other promises have been and are hereby expressly disclaimed.

Section 2.08 Allocationof Purchase Price. Seller and Buyer agree that the Purchase Price (plus any other items required to be treated as part of the consideration paid by Buyer hereunder for income Tax purposes) shall be allocated among the Purchased Assets for all purposes (including Tax and financial accounting) as shown on the allocation schedule, which shall be prepared in a manner consistent with Section 1060 of the Code and any analogous provisions of state, local or foreign Law (the “Allocation Schedule”). A draft of the Allocation Schedule shall be prepared by Buyer and delivered to Seller within ninety (90) days after the Closing Date. If Seller notifies Buyer in writing within sixty (60) days after its receipt of the Allocation Schedule that Seller objects to one or more items reflected in the Allocation Schedule, Seller and Buyer shall negotiate in good faith to resolve such dispute. Neither Buyer nor Seller shall unreasonably withhold its approval or consent with respect to the Allocation Schedule. If Seller and Buyer are unable to resolve any dispute with respect to the Allocation Schedule within 30 days following the date on which Seller submits a timely notification of its objection to Buyer, such dispute shall be resolved by the Independent Accountant. The fees and expenses of such accounting firm shall be borne in the manner set forth in Section 2.07(b)(ii). Buyer and Seller shall file all Tax Returns (including amended returns and claims for refund) and information reports in a manner consistent with the Allocation Schedule, and shall not take any position inconsistent with such Allocation Schedule on any Tax Return, before any taxing authority or Governmental Authority. Any adjustments to the Purchase Price pursuant to Section 2.07 herein shall be allocated in a manner consistent with the Allocation Schedule. For the avoidance of doubt, it is not the intention of this provision that the parties hereto should delay, postpone, or forgo the Closing if the parties hereto have not agreed to an Allocation Schedule prior to Closing.

Section 2.09 Withholding Tax. Buyer shall be entitled to deduct and withhold (or cause to be deducted and withheld) from any payment to be made under this Agreement all Taxes that Buyer may be required to deduct and withhold under any provision of applicable Tax Law. All such deducted and withheld amounts shall be promptly paid to the appropriate Governmental Authority and shall be treated for all purposes as having been delivered to Seller or such other party, as applicable, in respect of which such deduction and withholding was made. Buyer shall, prior to making any withholdings, use commercially reasonable efforts to reduce or eliminate any such withholding, including requesting and providing recipients of payments hereunder a reasonable opportunity to provide documentation establishing exemptions from or reductions of such withholdings.

Section 2.10 ThirdParty Consents. To the extent that Seller’s rights with respect to any Purchased Asset, including with respect to any Business Intellectual Property Registrations, Assigned Contract or Permit, may not be assigned to Buyer without the consent of another Person which has not been obtained, this Agreement shall not constitute an agreement to assign the same if an attempted assignment would constitute a breach thereof or be unlawful, and Seller, at its expense, shall use its reasonable best efforts to obtain any such required consent(s) as promptly as possible. If any such consent shall not be obtained or if any attempted assignment would be ineffective or would impair Buyer’s rights under the Purchased Asset in question so that Buyer would not in effect acquire the benefit of all such rights, Seller, to the maximum extent permitted by law and the Purchased Asset, shall act after the Closing as Buyer’s agent in order to obtain for it the benefits thereunder and shall cooperate, to the maximum extent permitted by Law and the Purchased Asset, with Buyer in any other reasonable arrangement designed to provide such benefits to Buyer.

Article III

CLOSING

Section 3.01 Closing. Subject to the terms and conditions of this Agreement, the consummation of the transactions contemplated by this Agreement (the “Closing”) shall take place remotely by exchange of documents and signatures (or their electronic counterparts), on the date hereof. The date on which the Closing is to occur is herein referred to as the “Closing Date”. Subject to the consummation of the Closing on the Closing Date, the sale and purchase of the Purchased Assets and the assumption of the Assumed Liabilities will be deemed effective as of 12:01 a.m. (California time) on the Closing Date.

Section 3.02 Closing Deliverables.

(a) At the Closing, Seller shall deliver to Buyer the following:

(i) a bill of sale in substantially the form of Exhibit B hereto (the “Bill of Sale”) and duly executed by Seller, transferring the tangible personal property included in the Purchased Assets to Buyer;

(ii) an assignment and assumption agreement in substantially the form of Exhibit C hereto (the “Assignment and AssumptionAgreement”) and duly executed by Seller, effecting the assignment to and assumption by Buyer of the Purchased Assets and the Assumed Liabilities;

(iii) an assignment in substantially the form of Exhibit D hereto (the “Business Intellectual Property Assignments”) and duly executed by Seller, transferring all of Seller’s right, title and interest in and to the Business Intellectual Property Assets to Buyer;

(iv) a Trademark Licensing Agreement in substantially the form of Exhibit E hereto (the “Trademark Licensing Agreement”) and duly executed by Seller;

(v) the Transition Services Agreement in substantially the form of Exhibit F hereto (the “Transition Services Agreement”) and duly executed by Seller;

(vi) the Reference Laboratory Services Agreement in substantially the form of Exhibit G hereto (the “Reference LaboratoryServices Agreement”) and duly executed by Seller;

(vii) the Employee Leasing Agreement in substantially the form of Exhibit H hereto (the “Employee Leasing Agreement”) and duly executed by Seller;

(viii) the Veterans Affairs Services License Agreement substantially in the form of Exhibit I hereto (the “VA LicenseAgreement”) and duly executed by Seller;

(ix) a certificate of the Secretary or an Assistant Secretary (or equivalent officer) of Seller certifying that attached thereto are true and complete copies of all resolutions adopted by the board of directors of Seller authorizing the execution, delivery and performance of this Agreement and the Ancillary Documents and the consummation of the transactions contemplated hereby and thereby, and that all such resolutions are in full force and effect and are all the resolutions adopted in connection with the transactions contemplated hereby and thereby;

(x) a certificate of the Secretary or an Assistant Secretary (or equivalent officer) of Seller certifying the names and signatures of the officers of Seller authorized to sign this Agreement, the Ancillary Documents and the other documents to be delivered hereunder and thereunder;

(xi) an IRS Form W-9 duly executed by Seller; and

(xii) a written notice substantially in the form of Exhibit J hereto and duly executed by Seller (the “Contribution Confirmation”), confirming the Contribution of the Closing ADS Payable in relation to the Closing Equity Consideration.

(b) At the Closing, Buyer shall deliver to Seller the following:

(i) the Closing Cash Consideration by wire transfer of immediately available funds to an account designated in writing by Seller to Buyer;

(ii) evidence reasonably satisfactory to the Seller that the board of directors authorized the issuance and transfer to Seller of the shares of Buyer ADSs constituting the Closing Equity Consideration, subject to (x) the finalization of the relevant reports of the board of directors and statutory auditor of Buyer and the (y) passing of the relevant resolutions of the board of directors of Buyer to be recorded in a notarial deed before a notary public;

(iii) the Bill of Sale duly executed by Buyer;

(iv) the Assignment and Assumption Agreement duly executed by Buyer;

(v) the Business Intellectual Property Assignments duly executed by Buyer;

(vi) the Trademark Licensing Agreement duly executed by Buyer;

(vii) the Transition Services Agreement duly executed by Buyer;

(viii) the Reference Laboratory Services Agreement duly executed by Buyer;

(ix) the Employee Leasing Agreement duly executed by Buyer;

(x) the VA License Agreement duly executed by Seller;

(xi) a certificate of the Secretary or an Assistant Secretary (or equivalent officer) of Buyer certifying that attached thereto are true and complete copies of all resolutions adopted by the board of directors of Buyer authorizing the execution, delivery and performance of this Agreement and the Ancillary Documents and the consummation of the transactions contemplated hereby and thereby, and that all such resolutions are in full force and effect and are all the resolutions adopted in connection with the transactions contemplated hereby and thereby, other than in relation to the issuance of the Buyers ADSs and the relevant underlying Ordinary Shares which are subject to (x) the finalization of the relevant reports of the board of directors and statutory auditor of Buyer and (y) the passing of the relevant resolutions of the board of directors of Buyer to be recorded in a notarial deed before a notary public; and

(xii) a certificate of the Secretary or an Assistant Secretary (or equivalent officer) of Buyer certifying the names and signatures of the officers of Buyer authorized to sign this Agreement, the Ancillary Documents and the other documents to be delivered hereunder and thereunder.

Article IV

REPRESENTATIONS AND WARRANTIES OF SELLER

Except as set forth in the correspondingly numbered Section of the Disclosure Schedules, Seller represents and warrants to Buyer that the statements contained in this ARTICLE IV are true and correct as of the date hereof.

Section 4.01 Organization and Qualification of Seller. Seller is a corporation duly organized, validly existing and in good standing under the Laws of the state of Delaware and has full corporate power and authority to own, operate or lease the properties and assets now owned, operated or leased by it and to carry on the Business as currently conducted. Seller is duly licensed or qualified to do business and is in good standing in each jurisdiction in which the ownership of the Purchased Assets or the operation of the Business as currently conducted makes such licensing or qualification necessary, except where the failure to be so qualified or licensed does not or would not reasonably be expected to have a Material Adverse Effect.

Section 4.02 Authority of Seller. Seller has full corporate power and authority to enter into this Agreement and the Ancillary Documents to which Seller is a party, to carry out its obligations hereunder and thereunder and to consummate the transactions contemplated hereby and thereby. The execution and delivery by Seller of this Agreement and any Ancillary Document to which Seller is a party, the performance by Seller of its obligations hereunder and thereunder and the consummation by Seller of the transactions contemplated hereby and thereby have been duly authorized by all requisite corporate action on the part of Seller. This Agreement and each Ancillary Document to which Seller is or will be a party has been duly executed and delivered by Seller, and (assuming due authorization, execution and delivery by Buyer) this Agreement constitutes and each Ancillary Document to which Seller is or will be a party constitutes or will constitute a legal, valid and binding obligation of Seller enforceable against Seller in accordance with its terms, except, in each case, to the extent that such enforcement may be subject to applicable bankruptcy, reorganization, insolvency, moratorium or similar laws of general application affecting the rights and remedies of creditors or secured parties and subject to general principles of equity (regardless of whether enforceability is considered in a proceeding at law or equity) (collectively, the “Enforceability Exceptions”).

Section 4.03 No Conflicts; Consents. The execution, delivery and performance by Seller of this Agreement and the Ancillary Documents to which it is a party, and the consummation of the transactions contemplated hereby and thereby, including the transfer and assignment of the Purchased Assets to Buyer, do not and will not: (a) conflict with or result in a violation or breach of, or default under, any provision of the certificate of incorporation, by-laws or other organizational documents of Seller; (b) conflict with or result in a violation or breach of any provision of any Law or Governmental Order applicable to Seller, the Business or the Purchased Assets; (c) except as set forth in Section 4.03 of the Disclosure Schedules, require the consent, notice or other action by any Person under, conflict with, result in a violation or breach of, constitute a default or an event that, with or without notice or lapse of time or both, would constitute a default under, result in the acceleration of or create in any party the right to accelerate, terminate, modify or cancel any Assigned Contract to which Seller is a party or by which Seller is bound or to which any of the Purchased Assets are subject; (d) result in the creation or imposition of any Encumbrance other than Permitted Encumbrances on the Purchased Assets; or (e) require the consent, notice, filing with, or other action by any Governmental Authority.

Section 4.04 FinancialReports. Section 4.04 of the Disclosure Schedules contains a copy of each Annual Financial Report and a copy of the Interim Financial Report (together with the Annual Financial Reports, the “Financial Reports”). The Financial Reports are based on the books and records of the Seller, and fairly present in all material respects the financial condition of the Business as of their respective dates and the results of the operations of the Business for the periods indicated, except that the Financial Reports do not include insurance, interest, taxes, amortization, impairments on intangible assets, or allocations of indirect corporate cost, and subject to the lack of footnote disclosure and changes resulting from normal year-end adjustments for the unaudited financial statements. Seller maintains a standard system of accounting established and administered in accordance with GAAP.

Section 4.05 Absence of Certain Changes, Events and Conditions. Since May 31, 2022, and other than in the ordinary course of business of the Business consistent with past practice, there has not been any:

(a) event, occurrence or development that has had, or could reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect;

(b) material change in any method of accounting or accounting practice for the Business, except as required by GAAP;

(d) cancellation of any material claims or amendment, termination or waiver of any material rights constituting Purchased Assets;

(e) material damage, destruction or loss, or any material interruption in use, of any Purchased Assets, whether or not covered by insurance;

(f) acceleration, termination, material modification to or cancellation of any Assigned Contract or Permit; or

(g) any Contract to do any of the foregoing.

Section 4.06 Material Contracts.

(a) Section 4.06(a) of the Disclosure Schedules lists each of the following Contracts (x) by which any of the Purchased Assets are bound or affected or (y) to which Seller is a party or by which it is bound that are material to the Business or the Purchased Assets (such Contracts, together with all Business Intellectual Property Agreements set forth in Section 4.08(b) of the Disclosure Schedules, being “Material Contracts”):

(i) all Contracts that require Seller to purchase or sell a stated portion of the requirements or outputs of the Business or that contain “take or pay” provisions;

(ii) all broker, distributor, dealer, manufacturer’s representative, franchise, agency, sales promotion, market research, marketing consulting and advertising Contracts;

(iii) all employment agreements and Contracts with Transfer Employees that are not cancellable without material penalty or without more than 30 days’ notice;

(iv) all Contracts with any Governmental Authority, other than any purchase order from the VA that involves aggregate consideration payable to the Seller of less than $100,000 (“Government Contracts”);

(v) all Contracts that limit or purport to limit the ability of Seller to compete in any line of business or with any Person or in any geographic area or during any period of time;

(vi) all joint venture, partnership or similar Contracts relating to the Business;

(vii) all Contracts for the sale of any of the Purchased Assets or for the grant to any Person of any option, right of first refusal or preferential or similar right to purchase any of the Purchased Assets;

(viii) all powers of attorney with respect to the Business or any Purchased Asset; and

(ix) all collective bargaining agreements or Contracts with any union covering employees that perform services for the Business.

(b) Each Material Contract is valid and binding on Seller in accordance with its terms and is in full force and subject to the Enforceability Exceptions. None of Seller or, to Seller’s Knowledge, any other party thereto is in breach of or default under (or is alleged to be in breach of or default under), or has provided or received any written notice of any intention to terminate, any Material Contract. No event or circumstance has occurred that, with notice or lapse of time or both, would constitute an event of default under any Material Contract or result in a termination thereof or would cause or permit the acceleration or other changes of any right or obligation or the loss of any benefit thereunder. Complete and correct copies of each Material Contract (including all modifications, amendments and supplements thereto and waivers thereunder) have been made available to Buyer. There are no material disputes pending or, to Seller’s Knowledge, threatened under any Assigned Contract.

Section 4.07 Title to Purchased Assets. Seller has good and valid title to, or a valid leasehold interest in, all of the Purchased Assets (other than with respect to the Business Intellectual Property Assets, as to which the representations and warranties in Section 4.08 should apply). All such Purchased Assets (including leasehold interests) are free and clear of Encumbrances except for Permitted Encumbrances and those items set forth in Section 4.07 of the Disclosure Schedules.

Section 4.08 Intellectual Property.

(a) Section 4.08(a) of the Disclosure Schedules contains a correct, current and complete list of: (i) all Business Intellectual Property Registrations, specifying as to each, as applicable: the title, mark, or design; the jurisdiction by or in which it has been issued, registered or filed; the patent, registration or application serial number; the issue, registration or filing date; and the current status; (ii) all unregistered Trademarks included in the Business Intellectual Property Assets, and (iii) certain of the Business Intellectual Property Assets and domain names other than Trade Secrets that are used or held for use in the conduct of the Business as currently conducted.

(b) Section 4.08(b) of the Disclosure Schedules contains a correct, current and complete list of all Business Intellectual Property Agreements, specifying for each the date, title, and parties thereto, and separately identifying the Business Intellectual Property Agreements: (i) under which Seller is a licensor or otherwise grants to any Person any right or interest relating to any Business Intellectual Property Asset; (ii) under which Seller is a licensee or is otherwise granted any right or interest relating to the Intellectual Property of any Person; and (iii) which otherwise relate to the Seller’s ownership or use of any Intellectual Property in the conduct of the Business as currently conducted. Seller has provided Buyer with true and complete copies (or in the case of any oral agreements, a complete and correct written description) of all such Business Intellectual Property Agreements, including all modifications, amendments and supplements thereto and waivers thereunder. Each Business Intellectual Property Agreement is valid and binding on Seller in accordance with its terms and is in full force and effect subject to the Enforceability Exceptions. Neither Seller nor, to Seller’s Knowledge, any other party thereto is alleged to be in breach of or default under, or has provided or received any notice of breach of, default under, or intention to terminate (including by non-renewal), any Business Intellectual Property Agreement.

(c) Except as set forth in Section 4.08(c) of the Disclosure Schedules, Seller is the sole and exclusive legal and beneficial (and with respect to the Business Intellectual Property Registrations, record) owner of all right, title and interest in and to the Business Intellectual Property Assets, and has the valid and enforceable right to use all other Intellectual Property used or held for use in or necessary for the conduct of the Business as currently conducted, in each case, free and clear of Encumbrances other than Permitted Encumbrances. Seller has entered into binding, valid and enforceable written Contracts with each current and former employee and independent contractor who is or was involved in or has contributed to the invention, creation, or development of any Business Intellectual Property Assets during the course of employment or engagement with Seller (including but not limited to any Business Employee and any Business Service Provider) whereby such employee or independent contractor (i) acknowledges Seller’s exclusive ownership of all Business Intellectual Property Assets invented, created or developed by such employee or independent contractor within the scope of his or her employment or engagement with Seller; (ii) grants to Seller a present, irrevocable assignment of any ownership interest such employee or independent contractor may have in or to such Intellectual Property; and (iii) irrevocably waives any right or interest, including any moral rights, regarding such Intellectual Property, to the extent permitted by applicable Law. All assignments and other instruments necessary to establish, record, and perfect Seller’s ownership interest in the Business Intellectual Property Registrations have been validly executed, delivered, and filed with the relevant Governmental Authorities and authorized registrars.

(d) Neither the execution, delivery, or performance of this Agreement, nor the consummation of the transactions contemplated hereunder, will result in the loss or impairment of or payment of any additional amounts with respect to, or require the consent of any other Person in respect of, Buyer’s right to own or use any Business Intellectual Property Assets or Licensed Business Intellectual Property in the conduct of the Business as currently conducted.

(e) All of the Business Intellectual Property Assets and Licensed Business Intellectual Property is valid and enforceable, and all Business Intellectual Property Registrations are subsisting and in full force and effect. Seller has taken reasonable steps to maintain and enforce the Business Intellectual Property Assets and Licensed Business Intellectual Property and to preserve the confidentiality of all Trade Secrets included in the Business Intellectual Property Assets. All required fees due as of Closing related to the Business Intellectual Property Registrations have been timely submitted with and paid to the relevant Governmental Authorities and authorized registrars. Seller has provided Buyer with true and complete copies of all file histories, certificates, office actions, correspondence with Governmental Authorities, assignments, and other instruments relating to the Business Intellectual Property Registrations. The Business Intellectual Property Assets and the Assigned Contracts constitute all of the non-Patent Intellectual Property and, to the Knowledge of Seller, all of the Patent Intellectual Property that in each case is used or held for use, in either case, either exclusively in, or reasonably necessary for, the conduct of the Business as currently conducted, other than commercially available off-the-shelf software licensed by Seller for its internal use.

(f) The conduct of the Business as currently and formerly conducted, including the use of the Business Intellectual Property Assets and Licensed Business Intellectual Property in connection therewith, and the products, processes, and services of the Business have not infringed, misappropriated, or otherwise violated the Intellectual Property or other rights of any Person. The conduct of the Business by Buyer immediately following the Closing, if conducted in the same manner as currently conducted by Seller, will not infringe, misappropriate or otherwise violate any Intellectual Property or other rights of Seller. To Seller’s Knowledge, no Person has infringed, misappropriated, or otherwise violated any Business Intellectual Property Assets or Licensed Business Intellectual Property in the past six (6) years.

(g) There are no Actions (including any opposition, cancellation, revocation, review, or other proceeding), whether settled, pending or, to Seller’s Knowledge, threatened (including in the form of offers to obtain a license): (i) alleging any infringement, misappropriation, or other violation of the Intellectual Property of any Person by Seller in the conduct of the Business; (ii) challenging the validity, enforceability, registrability, patentability, or ownership of any Business Intellectual Property Assets or Licensed Business Intellectual Property; or (iii) by Seller or any other Person alleging any infringement, misappropriation, or other violation by any Person of any Business Intellectual Property Assets. Seller is not subject to any outstanding or Governmental Order (including any motion or petition therefor) that restricts or impairs the use of any Business Intellectual Property Assets or Licensed Business Intellectual Property.

(h) Seller has complied with all applicable Laws concerning the collection, use, processing, storage, transfer, and security of personal information in the conduct of the Business. Since January 1, 2020, Seller has not (i) experienced any data breach or other security incident involving personal information in its possession or control or (ii) received any notice of any audit, investigation, complaint, or other Action by any Governmental Authority or other Person concerning the Seller’s collection, use, processing, storage, transfer, or protection of personal information or violation of any applicable Law concerning privacy, data security, or data breach notification, in each case, in connection with the conduct of the Business, and to Seller’s Knowledge, there are no facts or circumstances that could reasonably be expected to give rise to any such Action.

Section 4.09 Payors and Suppliers.

(a) Section 4.09(a) of the Disclosure Schedules sets forth the Material Payors of the Business for each of the three most recent fiscal years together with the volume of tests ordered by such Material Payor during such periods. Seller has not received any written notice, and none of the Material Payors set forth in Section 4.09(a) of the Disclosure Schedules has ceased, or to Seller’s Knowledge, intends to cease after the Closing, to use the goods or services of the Business or to otherwise terminate or materially reduce its relationship with the Business.

(b) Section 4.09(b) of the Disclosure Schedules sets forth the Material Suppliers of the Business for each of the three most recent fiscal years and the amount of purchases from each such Material Supplier during such periods. Seller has not received any written notice, and none of the Material Suppliers set forth Section 4.09(b) of the Disclosure Schedules has ceased, or, to Seller’s Knowledge, intends to cease, to supply goods or services to the Business or to otherwise terminate or materially reduce its relationship with the Business.

Section 4.10 Legal Proceedings; Governmental Orders.

(a) Except as set forth in Section 4.10(a) of the Disclosure Schedules, there are no Actions pending or, to Seller’s Knowledge, threatened against Seller (a) relating to or affecting the Business, the Purchased Assets or the Assumed Liabilities; or (b) that challenge or seek to prevent, enjoin or otherwise delay the transactions contemplated by this Agreement. No event has occurred or circumstances exist that may give rise to, or serve as a basis for, any such Action.

(b) Except as set forth in Section 4.10(b) of the Disclosure Schedules, there are no outstanding Governmental Orders and no unsatisfied judgments, penalties or awards against, relating to or affecting the Business or the Purchased Assets. Seller is in compliance in all material respects with the terms of each Governmental Order set forth in Section 4.10(b) of the Disclosure Schedules. To Seller’s Knowledge, no event has occurred or circumstances exist that may constitute or result in (with or without notice or lapse of time) a violation of any such Governmental Order.

Section 4.11 Compliance With Laws; Permits.

(a) Except as set forth in Section 4.11(a) of the Disclosure Schedules, Seller has complied since January 1, 2020, and is now complying, in all material respects with all Laws applicable to the conduct of the Business as currently conducted or the ownership and use of the Purchased Assets.

(b) All Permits required under applicable Law for Seller to conduct the Business as currently conducted or for the ownership and use of the Purchased Assets have been obtained by Seller and are valid and in full force and effect. All fees and charges due and owing with respect to such Permits as of the date hereof have been timely paid. Section 4.11(b) of the Disclosure Schedules lists all current Permits issued to Seller which are related to the conduct of the Business as currently conducted or the ownership and use of the Purchased Assets, including the names of the Permits and their respective dates of issuance and expiration. To the Knowledge of Seller, no event has occurred that, with or without notice or lapse of time or both, would reasonably be expected to result in the revocation, suspension, lapse or material limitation of any Permit set forth in Section 4.11(b) of the Disclosure Schedules.

(c) Since January 1, 2020, Seller has not received written notice from any Governmental Authority (including another Person on behalf of a Governmental Authority) or Third Party Payor claiming or alleging that Seller was not in compliance with any Healthcare Regulatory Laws applicable to the Business. Neither Seller nor any of its current officers, directors, or employees, nor any agent of Seller is a party to or bound by, any written order, individual integrity agreement, corporate integrity agreement, settlement or other agreement with any Governmental Authority concerning compliance with Healthcare Regulatory Laws with respect to the Business, and, to the Knowledge of Seller, no such agreement is threatened. Since January 1, 2020, neither Seller nor any Affiliate thereof has engaged in a voluntary disclosure to any Governmental Authority concerning any alleged, potential or actual non-compliance with any Healthcare Regulatory Laws in connection with the Business. Neither Seller, nor any of its officers, directors, or employees, or to the Knowledge of Seller, any of its agents has, in the operation of the Business, engaged in any activities since January 1, 2020 that are prohibited by or cause for criminal or civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other state or Federal Health Care Program under 42 U.S.C. §§ 1320a-7, 1320a-7a, 1320a-7b or 1395nn, 5 U.S.C. § 8901 et seq. (the Federal Employees Health Benefits program statute), or the regulations promulgated pursuant to such Healthcare Regulatory Laws.

(d) Except as set forth in Section 4.11(d) of the Disclosure Schedules, no civil, administrative, or criminal proceedings relating to Seller’s engagement with any Third Party Payors with respect to the Business are pending or, to the Knowledge of Seller, threatened or reasonably foreseeable, nor has Seller been subject to any such proceeding that has concluded since January 1, 2020. Seller is not subject to any pre- or post-payment utilization review by any Third Party Payor relating to the Business. No Third Party Payor has requested since January 1, 2020 or, to the Knowledge of Seller, is threatening, any recoupment, refund or set-off from Seller with respect to the Business except for recoupments, refunds or set-offs in amounts less than $10,000 on a claim by claim basis (taking each letter requesting or threatening any recoupment, refund or set-off from Seller as a single “claim”). Since January 1, 2020, no Third Party Payor has imposed any fine, penalty or other sanction relating to the Business on Seller. Seller has not been suspended or excluded and, to the Knowledge of Seller has not otherwise been the subject of adverse actions taken by any Third Party Payor with respect to the Business (excluding routine audits, surveys or investigations conducted in the ordinary course). Since January 1, 2020, Seller has not violated any condition of participation in, or any other rule, regulation, policy or standard of, any Third Party Payor in any material respect in the performance of the Business.

(e) Neither Seller nor, to the Knowledge of Seller, any of the Business Employees or Business Service Providers have been excluded, suspended, debarred or otherwise sanctioned by any Governmental Authority, including the U.S. Department of Health and Human Services Office of Inspector General or the General Services Administration, and, to the Knowledge of Seller, there are no facts or circumstances that could reasonably be expected to result in any such exclusion, suspension, debarment or sanction.

(f) Seller is, and since January 1, 2020 has at all times been, in compliance in all material respects with HIPAA and with all other applicable Healthcare Regulatory Laws relating to the privacy, security, use and disclosure of health information, including “protected health information” or “PHI” as defined under HIPAA and information related to genetic testing and genetic test results created, used, disclosed or stored in the course of the operations of the Business. Seller has the necessary agreements relating to the Business with all of Seller’s “business associates” as such term is defined by and as such agreements are required by HIPAA. True and complete copies of all HIPAA and health information privacy and security policies that have been used by Seller since January 1, 2020 have been provided to Buyer. Seller has consistently made its “Notice of Privacy Practices” (as defined under HIPAA) available to patients and conspicuously posted its notice on all websites owned or operated by the Seller. Seller has undertaken periodic risk assessments and provided periodic workforce training, each as required under HIPAA. Since January 1, 2020, no actions have been asserted in writing or, to the Knowledge of Seller, orally or threatened against Seller by any Person alleging a violation of such person’s privacy rights under any Healthcare Regulatory Laws. Seller maintains systems, policies and procedures to respond to “Security Incidents” (as defined under HIPAA) and complaints alleging violations of HIPAA and to identify and report all “Breaches” of “Unsecured Protected Health Information” (each as defined under HIPAA) in accordance with the Seller’s legal obligations.

(g) Since January 1, 2020, each healthcare professional who has provided any clinical services to or on behalf of the Business, including without limitation any laboratory director, was at the time of providing the clinical services duly licensed or authorized as required under applicable Law, as applicable, to practice his or her profession in the state where such clinical services were rendered, as applicable, and each healthcare professional who currently provides clinical services on behalf of the Business is duly licensed or authorized as required under applicable Law, as applicable, to practice his or her profession in the state in which healthcare professional is performing clinical services. To the knowledge of the Seller, no event has occurred and no fact, circumstance or condition exists that has or reasonably may be expected to result in the denial, loss, suspension, revocation, rescission, probation or any other disciplinary action of or to any such professional license or authorization in connection with the services presently rendered to or on behalf of the Business. No such healthcare professional since January 1, 2020: (i) has been sanctioned or disciplined by any licensing board or any other Governmental Authority, professional society, hospital, or Third Party Payor, (ii) has had a final judgment or settlement without judgment entered against him or her in connection with a malpractice claim, (iii) has been found liable or responsible for any civil offense reasonably related to qualifications or competence relating to his or her professional practice, and/or (iv) has been terminated for cause related to a health care quality, competence or misconduct concern.

Section 4.12 Product Liability; Warranties.

(a) Except as set forth in Section 4.12(a) of the Disclosure Schedules, Seller has not received any written, or to the Knowledge of the Seller, oral, notice and to the Knowledge of the Seller, none of their suppliers, distributors, sales agents or customers has received any written or oral notice, relating to any material claim alleging: (a) any product liability resulting from any alleged breach of contractual requirements, express or implied, applicable to such product; (b) any breach of any product warranty (whether express or implied), strict liability in tort, negligence design, specification, processing or manufacture of product or failure to warn with any applicable governmental, trade association or regulatory specifications or standards for any product. No material claim for product liability has been asserted in writing or, to the Knowledge of the Seller, orally, against the Seller and to the Knowledge of the Seller, no event has occurred that would reasonably be expected to result in such a claim.

(b) Seller has not effected, with respect to any of the Purchased Assets or any service provided by the Business, a voluntary recall, withdrawal or similar corrective action, nor has the Seller received any notice from any Governmental Authority requesting that it implement a recall, withdrawal or other corrective action with respect to any such services.

Section 4.13 Employment Matters.

(a) Section 4.13(a) of the Disclosure Schedules contains a list of all Persons who are independent contractors or consultants of the Business as of the date hereof (“Business Service Providers”), and sets forth for each such Person the following: (i) name, (ii) description of services provided, (iii) annual base compensation rate or contract fee; and (iv) commission, bonus or other incentive-based compensation.

(b) Since July 1, 2019, Seller has complied in all material respects with all applicable Laws concerning labor and employment and the terms of each applicable employment or services agreement with respect to all current and former (i) employees of Seller who dedicate or dedicated 100% of the working time to the Business (“Business Employees”) and (ii) Business Service Providers, including without limitation such Laws relating to wages, hours, discrimination in employment, whistleblower protections, retaliation, worker classification, workplace safety and health, immigration, employee data privacy and security, tax withholding and reporting, workers’ compensation, unemployment insurance, and employment termination. Except as set forth in Section 4.13(b) of the Disclosure Schedules, there is no material audit, investigation, proceeding, claim, charge, complaint, or grievance pending or, to the Knowledge of Seller, threatened against Seller relating to terms and conditions of employment, wages, hours, or unfair labor practices, including charges of unfair labor practices or harassment, discrimination, or retaliation complaints and the Seller has no knowledge of any facts or circumstances that would reasonably be expected to give rise to any such audit, investigation, proceeding, claim, charge, complaint, or grievance.

(c) No Business Employee is represented by any union with respect to his or her employment by Seller. To the Knowledge of Seller, there is no activity or proceeding by a labor union or Representative thereof to organize any Business Employee, nor have there been any strikes, slowdowns, work stoppages or threats thereof by or with respect to such employees during the last two (2) years.

Section 4.14 Employee Benefit Matters.

(a) “Benefit Plan” for purposes of this Agreement shall mean any pension, benefit, retirement, compensation, profit-sharing, deferred compensation, incentive, bonus, performance award, phantom equity, stock or stock-based, change in control, retention, severance, vacation, paid time off (PTO), medical, vision, dental, disability, welfare, Code Section 125 cafeteria, fringe-benefit and other similar agreement, plan, policy, program or arrangement, including each “employee benefit plan” within the meaning of Section 3(3) of ERISA, which is maintained or sponsored by Seller, or for which Seller or any of its ERISA Affiliates has or may have any Liability, in each case with respect to, or for the benefit of, any current or former employee, officer, director, retiree, independent contractor or consultant of the Business.

(b) [Intentionally Omitted]

(c) Except as set forth in Section 4.14(c) of the Disclosure Schedules, each Benefit Plan has been established, administered and maintained in accordance with its terms and in compliance with all applicable Laws (including the ERISA, the Code and any applicable local Laws) in all material respects. Each Benefit Plan that is intended to be qualified within the meaning of Section 401(a) of the Code (a “QualifiedBenefit Plan”) is so qualified and received a favorable determination letter from the Internal Revenue Service or is entitled to rely on a favorable opinion letter from the Internal Revenue Service with respect to such qualification, and to the Knowledge of Seller, nothing has occurred that could reasonably be expected to adversely affect the qualified status of any Qualified Benefit Plan. The requirements of COBRA have been met in all material respects with respect to each Benefit Plan subject to COBRA.

(d) Neither Seller, nor any ERISA Affiliate contributes to, has any obligation to contribute to, or has any Liability under or with respect to any employee benefit plan (whether or not a Benefit Plan as defined herein) that is a “defined benefit plan” as defined in ERISA §3(35) or a “multiemployer plan” within the meaning of ERISA §3(37).

(e) Except as set forth in Section 4.14(e) of the Disclosure Schedules and other than as required under COBRA or other applicable Law, no Benefit Plan or other arrangement provides post-termination or retiree health benefits to any individual for any reason beyond the end of the month in which the termination occurs.

(f) Except as set forth in Section 4.14(f) of the Disclosure Schedules, there is no pending or, to Seller’s Knowledge, threatened Action relating to a Benefit Plan (other than routine claims for benefits), and no Benefit Plan has since January 1, 2020 been the subject of an examination or audit by a Governmental Authority or the subject of an application or filing under, or is a participant in, an amnesty, voluntary compliance or similar program sponsored by any Governmental Authority, other than self-correction programs and/or the Voluntary Correction Program under the Internal Revenue Service’s Employee Plans Compliance Resolution System.

(g) Except as would not have a Material Adverse Effect, to the Knowledge of Seller, each Benefit Plan that is subject to Section 409A of the Code has been administered in material compliance with its terms and the operational and documentary requirements of Section 409A of the Code and all applicable regulatory guidance (including, notices, rulings and proposed and final regulations) thereunder. Seller does not have any obligation to gross up, indemnify or otherwise reimburse any individual involved in the Business for any excise taxes, interest or penalties incurred pursuant to Section 409A of the Code.

(h) Neither the execution of this Agreement nor any of the transactions contemplated by this Agreement will: (i) increase the amount payable under or result in any other material obligation pursuant to any Benefit Plan; (ii) result in “excess parachute payments” within the meaning of Section 280G(b) of the Code; or (iii) require a “gross-up” or other payment to any “disqualified individual” within the meaning of Section 280G(c) of the Code.

Section 4.15 Taxes. Except as set forth in Section 4.15 of the Disclosure Schedules:

(a) Seller has timely filed (or caused to be timely filed) all Tax Returns that were required to be filed by Seller with respect to the Purchased Assets or the Business. All such Tax Returns (i) were prepared in compliance with all applicable Laws and (ii) are true, complete and correct in all material respects.

(b) All Taxes related to the Purchased Assets or the Business due and owing by Seller (whether or not shown on any Tax Return) have been timely paid.

(c) Seller has withheld and paid each Tax required to have been withheld and paid in connection with amounts paid or owing to any Business Employee, independent contractor, creditor, customer, shareholder or other party related to the Purchased Assets or the Business, and complied with all information reporting and backup withholding provisions of applicable Law.

(d) No extension or waiver of a statute of limitations has been given or requested with respect to any Taxes of Seller with respect to the Purchased Assets or the Business, which extension or waiver is still in effect.

(e) There are no pending or threatened Actions against Seller by any taxing authority with respect to the Purchased Assets or the Business.

(f) There are no Encumbrances for Taxes upon any of the Purchased Assets nor, to Seller’s Knowledge, is any taxing authority in the process of imposing any Encumbrances for Taxes on any of the Purchased Assets (other than for current Taxes not yet due and payable).

(g) Seller is not a “foreign person” as that term is used in Treasury Regulations Section 1.1445-2.

(h) Seller is not, and has not been, a party to, or a promoter of, a “reportable transaction” within the meaning of Section 6707A(c)(1) of the Code and Treasury Regulations Section 1.6011 4(b).

(i) None of the Purchased Assets is (i) required to be treated as being owned by another person pursuant to the so-called “safe harbor lease” provisions of former Section 168(f)(8) of the Internal Revenue Code of 1954, as amended, (ii) subject to Section 168(g)(1)(A) of the Code, or (iii) subject to a disqualified leaseback or long-term agreement as defined in Section 467 of the Code.

Section 4.16 Brokers. Except for XMS Capital Partners LLC, no broker, finder or investment banker is entitled to any brokerage, finder’s or other fee or commission in connection with the transactions contemplated by this Agreement or any Ancillary Document based upon arrangements made by or on behalf of Seller.

Section 4.17 No Other Representations or Warranties. EXCEPT AS EXPRESSLY PROVIDED IN THIS ARTICLE IV AND IN THE ANCILLARY DOCUMENTS OR IN ANY CERTIFICATE DELIVERED HEREWITH OR THEREWITH, SELLER MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND, NATURE OR DESCRIPTION, EXPRESS OR IMPLIED, AND SELLER AND EACH COMPANY SPECIFICALLY DISCLAIMS ANY REPRESENTATIONS OR WARRANTIES OF MERCHANTABILITY, USAGE, SUITABILITY OR FITNESS FOR ANY PARTICULAR SELLER. THE REPRESENTATIONS AND WARRANTIES OF SELLER SET FORTH IN THIS ARTICLE IV AND IN THE ANCILLARY DOCUMENTS OR IN ANY CERTIFICATE DELIVERED HEREWITH OR THEREWITH ARE THE ONLY REPRESENTATIONS AND WARRANTIES OF SELLER TO BUYER WITH RESPECT TO THE PURCHASED ASSETS AND ASSUMED LIABILITIES, THE BUSINESS, THE SUBJECT MATTER OF THIS AGREEMENT, THE ANCILLARY DOCUMENTS AND THE TRANSACTIONS CONTEMPLATED HEREBY AND THEREBY.

Article V

REPRESENTATIONS AND WARRANTIES OF BUYER

Buyer represents and warrants to Seller that the statements contained in this ARTICLE V are true and correct as of the date hereof.

Section 5.01 Organization of Buyer. Buyer is a limited liability company (société anonyme) organized and existing under the laws of Belgium.

Section 5.02 Authorityof Buyer. Buyer has full limited liability company (société anonyme) power and authority to enter into this Agreement and the Ancillary Documents to which Buyer is a party, to carry out its obligations hereunder and thereunder and to consummate the transactions contemplated hereby and thereby. The execution and delivery by Buyer of this Agreement and any Ancillary Document to which Buyer is a party, the performance by Buyer of its obligations hereunder and thereunder and the consummation by Buyer of the transactions contemplated hereby and thereby have been duly authorized by all requisite limited liability company (société anonyme) action on the part of Buyer, other than in relation to the issuance of the Buyers ADSs and the relevant underlying Ordinary Shares which are subject to (x) the finalization of the relevant reports of the board of directors and statutory auditor of Buyer and (y) the passing of the relevant resolutions of the board of directors of Buyer to be recorded in a notarial deed before a notary public. This Agreement has been duly executed and delivered by Buyer, and (assuming due authorization, execution and delivery by Seller) this Agreement constitutes a legal, valid and binding obligation of Buyer enforceable against Buyer in accordance with its terms. When each Ancillary Document to which Buyer is or will be a party has been duly executed and delivered by Buyer (assuming due authorization, execution and delivery by each other party thereto), such Ancillary Document will constitute a legal and binding obligation of Buyer enforceable against it in accordance with its terms.

Section 5.03 No Conflicts; Consents. The execution, delivery and performance by Buyer of this Agreement and the Ancillary Documents to which it is a party, and the consummation of the transactions contemplated hereby and thereby, do not and will not: (a) conflict with or result in a violation or breach of, or default under, any provision of the certificate of incorporation, by-laws or other organizational documents of Buyer; (b) conflict with or result in a violation or breach of any provision of any Law or Governmental Order applicable to Buyer or by which any property or asset or Buyer is bound or affected; or (c) conflict with or violate, result in any material breach of, constitute a material default (or an event that, without notice or lapse of time or both, would become a material default) under, accelerate performance required by the terms of or result in the termination, suspension or modification of, or give to others any rights of termination, acceleration or cancellation of, any contract or agreement to which Buyer is a party or by which Buyer or its assets are bound. No consent, approval, Permit, Governmental Order, declaration or filing with, or notice to, any Governmental Authority is required by or with respect to Buyer in connection with the execution and delivery of this Agreement and the Ancillary Documents and the consummation of the transactions contemplated hereby and thereby, except for such filings as may be required under the HSR Act and such consents, approvals, Permits, Governmental Orders, declarations, filings or notices which, in the aggregate, would not prevent Buyer form consummation of the transactions contemplated hereby and thereby.

Section 5.04 Buyer Capitalization. As of June 30, 2022, the validly issued share capital of Buyer consists solely of 155,969,226 shares of no nominal value, all of which are unconditionally subscribed and paid up. The board of directors of Buyer has on the date hereof a sufficient authorized capital to satisfy Buyer’s obligations under this Agreement in relation to the Closing Equity Consideration. The underlying Buyer Ordinary Shares representing the Buyer ADSs issuable pursuant to the terms of this Agreement, and that will comprise a portion of the Purchase Price, when issued in accordance with the provisions of this Agreement, will be validly issued, fully paid and nonassessable, free of any liens, claims, or other encumbrances, except for restrictions on transfer under applicable securities laws, and not subject to preemptive rights created by statute, the Buyer’s articles of association or any agreement or document to which Buyer is a party or by which it or its assets is bound.

Section 5.05 SEC Filings; Buyer Financial Statements.

(a) Since November 3, 2021, Buyer has filed all forms, reports and documents required to be filed by Buyer with the Securities and Exchange Commission (the “SEC”) and (if and to the extent such forms, reports and documents are not available on EDGAR) has made available to Seller such forms, reports and documents in the form filed with the SEC. All such required forms, reports and documents filed through the date hereof are referred to herein as the “Buyer SEC Reports” As of their respective dates, the Buyer SEC Reports (i) were prepared in all material respects in accordance with the requirements of the Securities Act or the Exchange Act, as the case may be, and the rules and regulations of the SEC thereunder applicable to such Buyer SEC Reports, and (ii) did not at the time they were filed (or if subsequently amended or superseded by a filing prior to the date of this Agreement, then on the date of such subsequent filing) contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading. None of Buyer’s subsidiaries is required to file any forms, reports or other documents with the SEC.

(b) Each of the consolidated financial statements (including, in each case, any related notes thereto) contained in the Buyer SEC Reports (the “Buyer Financials”) (i) complied as to form in all material respects with the published rules and regulations of the SEC with respect thereto, (ii) was prepared in accordance with the IFRS applied on a consistent basis throughout the periods involved (except as may be indicated in the notes thereto or, in the case of unaudited interim financial statements) and (iii) fairly presented the consolidated financial position of Buyer and its subsidiaries as at the respective dates thereof and the consolidated results of Buyer’s operations, cash flows and shareholders’ equity for the periods indicated, except that the unaudited interim financial statements, prepared in accordance with International Accounting Standard (IAS) 34, may not contain all the footnotes required by IAS 34 for audited statements and were or are subject to normal and recurring year-end adjustments that Buyer does not expect to be material, individually or in the aggregate. The consolidated statement of financial position of Buyer contained in the Buyer SEC Reports as of December 31, 2021 is hereinafter referred to as the “Buyer Statement of Financial Position.” Neither Buyer nor any of its subsidiaries has any liabilities (absolute, accrued, contingent or otherwise), except for (i) liabilities reflected on the Buyer Statement of Financial Position, (ii) liabilities incurred since the date of the Buyer Statement of Financial Position in the ordinary course of business consistent with past practices, (iii) liabilities incurred in connection with this Agreement, (iv) liabilities that have been included or reflected in the information that has been publicly disclosed by Buyer after December 31, 2021 and (v) liabilities that would not have a Material Adverse Effect on Buyer.

Section 5.06 Solvency. After giving effect to the transactions contemplated hereby (including any financing obtained by Buyer coincident with the Closing), the Buyer (a) will be solvent (in that the fair saleable value of its assets (including goodwill, on a consolidated basis with its subsidiaries) will not be less than the amount required to pay its probable liability on its debts as they become absolute and matured), (b) will have adequate capital with which to engage in its business, and (c) will not have incurred and does not immediately plan to incur debts beyond its ability to pay as they become absolute and matured.

Section 5.07 Brokers. Except for Jefferies LLC, no broker, finder or investment banker is entitled to any brokerage, finder’s or other fee or commission in connection with the transactions contemplated by this Agreement or any Ancillary Document based upon arrangements made by or on behalf of Buyer.

Section 5.08 LegalProceedings. There are no Actions pending or, to Buyer’s knowledge, threatened against or by Buyer or any Affiliate of Buyer that challenge or seek to prevent, enjoin or otherwise delay the transactions contemplated by this Agreement. No event has occurred or circumstances exist that may give rise or serve as a basis for any such Action.

Section 5.09 Medicare Reference Laboratory Limitation. Buyer is, and has at all times has been, in compliance with 42 U.S.C. § 1395l(h)(5)(A)(ii)(III) (the “30% Reference Lab Limitation”), and Buyer does not reasonably expect Buyer’s acquisition of the Purchased Assets or Buyer’s entering into and performing under the Ancillary Documents to result in it exceeding the 30% Reference Lab Limitation after Closing.

Section 5.10 Acknowledgement by Buyer. Buyer acknowledges and agrees that it has conducted its own independent review and analysis of, and, based thereon, has formed an independent judgment concerning, the business, assets, condition, operations and prospects of the Business. In entering into this Agreement, Buyer has relied solely upon its own investigation and analysis and the representations and warranties of Seller set forth in this Agreement, and Buyer acknowledges that, other than as set forth in this Agreement and in the certificates or other instruments delivered pursuant hereto, neither Seller nor any of its respective directors, officers, employees, Affiliates, stockholders, agents or representatives makes or has made any representation or warranty, either express or implied, including (x) as to the accuracy or completeness of any of the information provided to Buyer or any of its agents, representatives, lenders or Affiliates prior to the execution of this Agreement or (y) with respect to any projections, forecasts, estimates, plans or budgets of future revenues, expenses or expenditures, future results of operations (or any component thereof), future cash flows (or any component thereof) or future financial condition (or any component thereof) of Seller heretofore or hereafter delivered to Buyer or any of its respective agents, representatives, lenders or Affiliates. Except for the representations and warranties of Seller expressly set forth in ARTICLE IV and in the Ancillary Documents, Buyer acknowledges that neither Seller nor any other Person on its behalf makes any other express or implied representation or warranty with respect to the Seller, the Business, the Purchased Assets, the Excluded Assets, the Assumed Liabilities or the Excluded Liabilities, or with respect to any other information provided to Buyer in connection with the transactions contemplated by this Agreement.

Article VI

COVENANTS

Section 6.01 [Intentionally Omitted]

Section 6.02 [Intentionally Omitted]

Section 6.03 [Intentionally Omitted]

Section 6.04 [Intentionally Omitted]

Section 6.05 Employees and Employee Benefits.

(a) Commencing as of the Closing Date, Buyer will offer employment, on an “at-will” basis, to the employees listed in Section 6.05(a) of the Disclosure Schedules (the “Leased Employees”) to become effective as of the fourteenth (14th) day after the Closing Date (the “Employment Commencement Date”) for that certain subset of the Leased Employees who meet Buyer’s standard hiring contingencies and accept Buyer’s offers of employment (the “TransferEmployees”). Seller shall lease the Leased Employees to Buyer during the period between the Closing Date and the Employment Commencement Date (the “Leasing Period”), in accordance with the terms and conditions of the Employee Lease Agreement. The Leased Employees shall remain fully employed by Seller through the duration of the Leasing Period. With respect to the Transfer Employees Seller shall terminate such Transfer Employees as of the Employment Commencement Date. Seller shall bear any and all obligations and liability under the WARN Act resulting from employment losses pursuant to this Section 6.05, if any; provided that, Buyer shall hire a sufficient number of Transfer Employees so that the WARN Act’s notice requirements will not be implicated and agrees to employ such Transfer Employees until the end of the WARN Act aggregation period, no less than ninety-one (91) days from the Employment Commencement Date. Buyer shall bear any and all obligations and liability under the WARN Act resulting from employment losses that occur after the Employment Commencement Date.

(b) Seller shall be solely responsible, and Buyer shall have no obligations whatsoever for, any compensation or other amounts payable to any current or former Business Employee and/or Business Service Provider, including, without limitation, hourly pay, commission, bonus, salary, fringe, pension or profit sharing benefits or severance pay for any period relating to the service with Seller at any time on or prior to the Employment Commencement Date, subject to the terms and conditions of the Employee Lease Agreement, and Seller shall pay all such amounts to all entitled persons in accordance with any applicable plan, program, policy, arrangement or agreement; provided,however, that, Buyer shall assume and honor the accrued paid vacation and/or sick leave balance, as of the Employment Commencement Date, for each Transfer Employee who becomes employed by Buyer in connection with the transactions contemplated by this Agreement.

(c) Seller shall remain solely responsible for the satisfaction of all claims for medical, dental, life insurance, health accident or disability benefits brought by or in respect of current or former Business Employees and/or Business Service Provider, or the spouses, dependents or beneficiaries of any of the foregoing, as applicable, which claims relate to events occurring on or prior to the Employment Commencement Date, subject to the terms and conditions of the Employee Lease Agreement. Seller also shall remain solely responsible for all worker’s compensation claims of any current or former Business Employees and/or Business Service Providers which relate to events occurring on or prior to the Closing Date. Seller shall pay, or cause to be paid, all such amounts to the appropriate persons as and when due. Buyer shall maintain any required coverage under any statutory workers’ compensation scheme on the Leased Employees, sufficient to comply with all applicable Laws, during the Leasing Period. Buyer shall take all necessary steps to maintain Seller as an additional insured covered by any such workers’ compensation insurance policy and shall include an endorsement, and promptly provide a copy of such endorsement in writing to Buyer, to any such workers’ compensation insurance policy that explicitly provides that Buyer is obligated to maintain workers’ compensation and employer liability insurance on the Leased Employees, during the Leasing Period.

(d) Each Transfer Employee who becomes employed by Buyer in connection with the transactions contemplated by this Agreement shall be eligible to receive (i) from the Employment Commencement Date until December 31, 2022 (or until termination of employment, if earlier), an annual base salary or an hourly wage rate, as applicable, that is not less than that provided to such Transfer Employee immediately prior to the Closing Date, (ii) during calendar year 2023, an annual base salary or an hourly wage rate, as applicable, that is comparable, in the reasonable determination of Buyer, to the annual base salary or hourly wage rate, as applicable, of similarly-situated employees of Buyer, and (iii) from the commencement of such employment until December 31, 2023, (x) incentive compensation opportunities that are comparable, in the reasonable determination of Buyer, to those provided to similarly-situated employees of Buyer; provided, however, that the Transfer Employees shall not be entitled to receive any equity compensation in calendar year 2022 or any equity compensation other than stock options in calendar year 2023, and (y) employee benefits that are not less favorable, in the aggregate, than those provided to similarly-situated employees of Buyer.

(e) Each Transfer Employee who becomes employed by Buyer in connection with the transaction shall be given service credit for the purpose of eligibility under the group health plan and eligibility and vesting only under the defined contribution retirement plan for his or her period of service with the Seller prior to the Employment Commencement Date; provided, however, that (i) such credit shall be given pursuant to payroll or plan records, at the election of Buyer, in its sole and absolute discretion; and (ii) such service crediting shall be permitted and consistent with Buyer’s defined contribution retirement plan.

(f) Seller shall be responsible for providing all notices and continuation coverage required under COBRA (such notices and coverage, the “COBRA Continuation Coverage”) to all Business Employees (and their respective spouses and dependents, as applicable) who are or become “M&A Qualified Beneficiaries” (as such term is defined in Treasury Regulations §54.4980B-9) as a result of the consummation of the transactions described in this Agreement. Specifically, Seller agrees that all obligations to provide COBRA Continuation Coverage to M&A Qualified Beneficiaries are being allocated to Seller.

(g) Buyer and its Affiliates shall user their commercially reasonable efforts to cause each employee benefit plan, program, arrangement, agreement, policy or commitment sponsored or maintained by Buyer or any of its Affiliates following the Closing and in which any Transfer Employee (or the spouse, domestic partner or any dependent of any Transfer Employee) participates or is eligible to participate (each, a “Buyer Plan”) that is a welfare benefit plan, within the meaning of Section 3(1) of ERISA, (i) to waive any and all eligibility waiting periods, actively-at-work requirements, evidence of insurability requirements, pre-existing condition limitations and other exclusions and limitations with respect to the Transfer Employees and their spouses, domestic partners and dependents, and (ii) subject to Seller’s timely provision of such information to Buyer, to recognize for each Transfer Employee for purposes of applying annual deductible, co-payment and out-of-pocket maximums under such Buyer Plan any deductible, co-payment and out-of-pocket expenses paid by the Transfer Employee and the Transfer Employee’s spouse, domestic partner and dependents under the corresponding Benefit Plan during the plan year of such Benefit Plan in which occurs the later of the Employment Commencement Date and the date on which the Transfer Employee begins participating in such Buyer Plan.

(h) Nothing contained in this Section 6.05, express or implied, shall, or shall be construed to (i) constitute an amendment to or any other modification of any Benefit Plan, Buyer Plan or any employee benefit plan, program or policy that is made available by the Seller, Buyer or their Affiliates, (ii) create any third-party beneficiary rights in any Person, including any Leased Employee or Transfer Employee, (iii) limit any Person’s right to amend or terminate any Benefit Plan, Buyer Plan or other employment benefit or compensation plan, policy, program, agreement or arrangement, or (iv) alter the at-will status (if and as applicable) of any Leased Employee or Transfer Employee’s employment.

Section 6.06 Confidentiality. From and after the Closing, Seller shall, and shall cause its Affiliates to, hold, and shall use its commercially reasonable efforts to cause its or their respective Representatives to hold, in confidence any and all information, whether written or oral, concerning the Business, except to the extent that Seller can show that such information (a) is generally available to and known by the public through no fault of Seller, any of its Affiliates or its Representatives; or (b) except as provided in the Transition Services Agreement, is lawfully acquired without obligation of confidentiality by Seller, any of its Affiliates or their respective Representatives from and after the Closing from sources which are not to Seller’s Knowledge or the knowledge of the applicable Affiliate or Representative prohibited from disclosing such information by a legal, contractual or fiduciary obligation. If Seller, its Affiliates or their respective Representatives are compelled to disclose any information by judicial or administrative process or by other requirements of Law, Seller shall promptly notify Buyer in writing and shall disclose only that portion of such information which Seller is advised by its counsel in writing is legally required to be disclosed, provided that Seller shall use commercially reasonable efforts to obtain an appropriate protective order or other reasonable assurance that confidential treatment will be accorded such information.

Section 6.07 Non-Competition; Non-Solicitation.

(a) For a period commencing on the Closing Date and continuing through the 2025 Earn-Out Period (the “Restricted Period”), Seller shall not directly or indirectly, (i) engage in or assist others (other than by virtue of any Ancillary Document or the VA Arrangement) in engaging in the Restricted Business in the Territory; (ii) have an interest in any Person (other than by virtue of holding the shares of Buyer ADSs) that engages directly or indirectly in the Restricted Business in the Territory in any capacity, including as a partner, shareholder, member, employee, principal, agent, trustee or consultant; or (iii) cause, induce or encourage any material actual or prospective client, Third Party Payor, customer, referral source, supplier or licensor of the Business (including any existing or former client or customer of Seller and any Person that becomes a client or customer of the Business after the Closing), or any other Person who has a material business relationship with the Business, to terminate or materially and substantively modify any such actual or prospective relationship, except to the extent the same occurs to facilitate the transition of the VA Arrangement to Buyer. Notwithstanding the foregoing, nothing herein shall prohibit the Seller or its Affiliates, after the Closing Date, from:

(i) owning, directly or indirectly, solely as a passive investment in which Seller is not a controlling Person, securities of any Person equal to or less than five percent (5%) of the outstanding equity securities that are available in the private marketplace or publicly-traded on a recognized domestic or foreign securities exchange or over-the-counter market, provided, however, that the foregoing restriction shall not limit the ability of Seller or its Affiliates to continue to hold passive investments in any amount of any Person to the extent the same are owned by Seller or its Affiliates as of the Closing Date;

(ii) acquiring or owning, directly or indirectly, an equity interest (regardless of the percentage of such equity stake) of a Person that conducts a Restricted Business where the revenues derived by such Person from such Restricted Business constitute less than [***] of the total consolidated revenues of such Person at the time of the acquisition;

(iii) designing, manufacturing, assembling, acquiring, incorporating, selling, servicing, marketing or otherwise providing any components, reagents and other materials that would have otherwise constituted Inventory under this Agreement that are or could be used in both the Restricted Business and outside the Restricted Business;

(iv) developing, creating, engineering, selling, servicing, marketing or otherwise commercializing any in vitro test with a prognostic and / or diagnostic indication for [***]; or

(v) being a party to or performing its obligations under that certain License Agreement between Seller and Epic Sciences, Inc. dated March 18, 2019 and that certain Laboratory Services Agreement between Seller and Epic Sciences, Inc. dated March 18, 2019.

(b) During the Restricted Period, Seller shall not directly or indirectly, solicit any Transfer Employees who have accepted an offer of employment from Buyer pursuant to Section 6.05(a), or encourage any Transfer Employee to leave such employment, except pursuant to a general solicitation which is not directed specifically to any Transfer Employees; provided, that nothing in this Section 6.07(b) shall prevent Seller from soliciting, hiring or employing by any means (i) Transfer Employees who have been extended an offer of employment from Buyer, and declined such offer; (ii) any employee whose employment has been terminated by Buyer; or (iii) after 90 days from the date of termination of employment, any employee whose employment has been terminated for any reason other than by Buyer. For the avoidance of doubt, nothing in this Section 6.07(b) shall restrict Seller or its Affiliates from hiring any Transfer Employee that responds to a general solicitation which is not directed specifically to any Transfer Employees.

(c) The taking of any action by Exact Sciences Corporation, a Delaware corporation and the parent of Seller, or any of its controlled Affiliates that would constitute a breach of this Section 6.07 if taken by Seller, shall be deemed to have been taken by Seller.

(d) Seller acknowledges that a breach or threatened breach of this Section 6.07 would give rise to irreparable harm to Buyer, for which monetary damages would not be an adequate remedy, and hereby agrees that in the event of a breach or a threatened breach by Seller of any such obligations, Buyer shall, in addition to any and all other rights and remedies that may be available to it in respect of such breach, be entitled to equitable relief, including a temporary restraining order, an injunction, specific performance and any other relief that may be available from a court of competent jurisdiction (without any requirement to post bond).

(e) Seller acknowledges that the restrictions contained in this Section 6.07 are reasonable and necessary to protect the legitimate interests of Buyer and constitute a material inducement to Buyer to enter into this Agreement and consummate the transactions contemplated by this Agreement. In the event that any covenant contained in this Section 6.07 should ever be adjudicated to exceed the time, geographic, product or service or other limitations permitted by applicable Law in any jurisdiction, then any court is expressly empowered to reform such covenant, and such covenant shall be deemed reformed, in such jurisdiction to the maximum time, geographic, product or service or other limitations permitted by applicable Law. The covenants contained in this Section 6.07 and each provision hereof are severable and distinct covenants and provisions. The invalidity or unenforceability of any such covenant or provision as written shall not invalidate or render unenforceable the remaining covenants or provisions hereof, and any such invalidity or unenforceability in any jurisdiction shall not invalidate or render unenforceable such covenant or provision in any other jurisdiction.

Section 6.08 [Intentionally Omitted]

Section 6.09 Books and Records.

(a) Seller may retain an archival copy of all Business Books and Records, Assigned Contracts and other documents or materials conveyed hereunder for recordkeeping purposes; provided that, except as otherwise contemplated by the Transition Services Agreement, access to such information shall be restricted to Seller’s legal counsel and such employees and other advisors of the Seller who have a “need to know” such information to comply with the terms of this Agreement or Law.

(b) In order to facilitate the resolution of any claims made by or against or incurred by Buyer after the Closing, or for any other reasonable purpose, in accordance with Seller’s routine recordkeeping policies, but in no event for a period of less than seven years following the Closing, Seller shall:

(i) retain the Business Books and Records (including personnel files) of Seller; and

(ii) upon reasonable notice, afford the Buyer’s Representatives reasonable access (including the right to make, at Buyer’s expense, photocopies), during normal business hours, to such Business Books and Records.

(c) To the extent required to comply with the Securities Act of 1933, as amended, the Securities Exchange Act of 1934, as amended, or any corresponding foreign securities rules or laws and any obligation of Buyer thereunder to prepare and include audited financial statements with respect to the Business, Seller shall, following the Closing (i) use commercially reasonable efforts to provide Buyer with the financial statements and other information and documents pertaining to the Business that Buyer reasonably determines to include in its filings in accordance with applicable securities laws and (ii) use commercially reasonable efforts to cause its independent certified public accountant to promptly deliver such information and provide access to files and work papers in connection therewith as Buyer may reasonably request. Buyer shall reimburse Seller for any reasonable out-of-pocket expenses actually incurred by Seller for services performed by Seller’s independent certified public accounting firm directly attributable to requests by Buyer under this Section 6.09(c). For the avoidance of doubt, Buyer acknowledges that Seller has not prepared any separate audited financial statements specific to the Business and is not obligated by any provision of this Agreement to prepare or deliver any such separate audited financial statements specific to the Business.

(d) Neither Buyer nor Seller shall be obligated to provide the other party with access to any books or records (including personnel files) pursuant to this Section 6.09 where such access would violate any Law.

Section 6.10 [Intentionally Omitted]

Section 6.11 Public Announcements. Unless otherwise required by applicable Law or stock exchange requirements (based upon the reasonable advice of counsel), no party to this Agreement shall make any public announcements in respect of this Agreement or the transactions contemplated hereby or otherwise communicate with any news media regarding the same without the prior written consent of the other party (which consent shall not be unreasonably withheld, conditioned or delayed), and the parties shall cooperate as to the timing and contents of any such announcement.

Section 6.12 Bulk Sales Laws. The parties hereby waive compliance with the provisions of any bulk sales, bulk transfer or similar Laws of any jurisdiction that may otherwise be applicable with respect to the sale of any or all of the Purchased Assets to Buyer.

Section 6.13 Post-Closing Receivables. From and after the Closing, if Seller or its Affiliates receives or collects any funds relating to any Purchased Asset payable in respect of the Business on account of the Buyer’s operation of the Business following the Closing Date, Seller or its Affiliates shall aggregate and hold in trust for the benefit of Buyer any such funds collected in a calendar month, and remit such funds to Buyer within five (5) Business Days after the end of such calendar month. From and after the Closing, if Buyer or its Affiliate receives or collects any funds relating to any Excluded Asset or related to any Purchased Assets on account of the Seller’s operation of the Business prior to the Closing Date, Buyer or its Affiliates shall aggregate and hold in trust for the benefit of Seller any such funds collected in a calendar month, and remit such funds to Seller within five (5) Business Days after the end of such calendar month.

Section 6.14 Transfer Taxes. All transfer, documentary, sales, use, stamp, registration, value added and other similar Taxes and fees (including any penalties and interest) incurred in connection with this Agreement and the Ancillary Documents (including any real property transfer Tax and any other similar Tax) shall be borne and paid when due 50% by Buyer and 50% by Seller. Buyer shall, as appropriate pursuant to applicable Law, at its own expense, timely file any Tax Return or other document with respect to such Taxes or fees (and Seller shall cooperate with respect thereto as necessary).

Section 6.15 TaxMatters. In the case of any personal property, real property, ad valorem, or similar Taxes that are attributable to a taxable period that includes (but does not end on) the Closing Date, the portion of any such Tax that is allocable to the Pre-Closing Tax Period shall be deemed equal to the amount of such Tax for the entire taxable period multiplied by a fraction the numerator of which is the number of calendar days in the portion of the taxable period ending on, and including, the Closing Date and the denominator of which is the number of calendar days in the entire taxable period (any remaining Tax for such taxable period shall be allocable to the period beginning after the Closing Date). Any Tax allocated under this provision to the Pre-Closing Tax Period shall be an Excluded Liability; any Tax allocated under this provision to the portion of the taxable period beginning after the Closing Date shall be an Assumed Liability. Notwithstanding anything in this Agreement to the contrary, Buyer shall have no right to inspect or review any U.S. federal, state or local income Tax Returns relating to income Taxes of a consolidated, combined, unitary or other similar group that includes Seller and any one or more of the Affiliates or stockholders of Seller.

Section 6.16 Further Assurances. Following the Closing, each of the parties hereto shall, and shall take commercially reasonable efforts to cause their respective Affiliates to, execute and deliver such additional documents, instruments, conveyances and assurances and take such further actions as may be reasonably required to carry out the provisions hereof and give effect to the transactions contemplated by this Agreement and the Ancillary Documents. To the extent that Seller discovers any other information after the Closing that constitute Business Books and Records or Business Intellectual Property Assets, then Seller shall so notify Buyer and Seller shall promptly effect a transfer of such information or Business Intellectual Property Assets to Buyer for no additional consideration.

Section 6.17 Acknowledgement. Although Buyer is acquiring from Seller patent rights only to the extent included in the Business Intellectual Property Assets, Seller acknowledges that Buyer or any Affiliate of Buyer may, in its discretion, elect to file patent applications and patents claiming other aspects of the Purchased Assets, and that Buyer or its Affiliate shall, as between the parties hereto, own any such patent applications and patents.

Section 6.18 Delivery of Files and Records.

(a) To the extent not delivered to Buyer on the Closing Date, Seller shall:

(i) except as Buyer may otherwise consent to in writing, deliver to Buyer all Business Books and Records (excluding Later-Disclosed Business Books and Records to be delivered pursuant to Section 6.18(a)(ii)), including all protocols, procedures, specifications, historical patient test results from the seven (7) years prior to the Closing Date, quality metrics, and other Business-related information, records, data, patent applications, correspondence files within Seller’s possession or control and kept in the ordinary course of business, and all submissions, inquiries and correspondence files with Medicare Administrative Contractors and other Governmental Authorities (except those reasonably necessary for Seller to perform its obligations under the VA Arrangement, unless and until such VA Arrangement is terminated as set forth in Section 6.20), promptly after the Closing Date;

(ii) promptly reduce any Later-Disclosed Trade Secrets included in any Business Intellectual Property Assets or Later-Disclosed Business Books and Records to a complete and accurate written format that no longer includes any Non-GPS Trade Secrets (the “GPS TradeSecrets”), deliver such GPS Trade Secrets and such Later-Disclosed Books and Records to Buyer with reasonably promptness after the Closing Date in reasonable increments on a rolling basis, and in a manner reasonably designed to prioritize delivery of GPS Trade Secrets so as to facilitate Buyer’s establishment of a laboratory to perform the GPS Test;

(iii) as and when reasonably requested by Buyer, and at Seller’s sole expense, reasonably assist Buyer in testing the effectiveness of the GPS Trade Secrets to ensure such GPS Trade Secrets function to perform the GPS Test in substantially the same manner as so performed by Seller immediately prior to the Closing Date;

(iv) if Buyer so requests after the Closing Date, provide Buyer reasonable access to Seller’s records relating to the assignment by inventors of the inventions claimed in the patent rights included in the Business Intellectual Property Assets to Seller (or any predecessor-in-interest), and allow Buyer to make copies of any such records for its legal archive.

(b) If any Governmental Authority requires access to portions of the Books and Records of Seller for legal or regulatory purposes relating to the Purchased Assets or the Business, then Seller shall cooperate with such Governmental Authority and make such portions available to the Governmental Authority for such purposes. To the extent reasonably requested by Buyer, Seller shall grant to Buyer, and use commercially reasonable efforts to cause its Representatives and contractual counterparties to grant to Buyer, a “right of reference or use” (or, in any other country or jurisdiction, the equivalent authority to rely upon, and otherwise use, an investigation for the purpose of filing for, conducting a clinical trial for or obtaining regulatory approval, including the ability to make available the underlying raw data from the investigation for audit by the applicable Regulatory Authority in such country or other jurisdiction, if necessary) with respect to Seller’s Books and Records. Notwithstanding the foregoing, the parties shall cooperate in good faith to obtain an appropriate protective order or other reasonable written assurance that confidential treatment will be accorded any Books and Records implicated by this Section 6.18(b) (including, insofar as to ensure Buyer is not granted or entitled to access to such Books and Records beyond its rights of access under this Agreement).

(c) With regard to clinical study agreements listed in Section 6.18(c) of the Disclosure Schedules that are not Assigned Contracts, Seller shall use commercially reasonable efforts after Closing to coordinate and cooperate with Buyer with regard to any continuing rights or obligations thereunder, including with respect to communications with the counterparties to such agreements, and otherwise cooperate with Buyer in any other reasonable arrangement designed to provide continuing benefits thereunder to Buyer. Seller shall use commercially reasonable efforts after Closing to transfer to Buyer the clinical data and samples relevant to the clinical study agreements that are Assigned Contracts, to the extent the same (i) are still within Seller’s possession; (ii) can be identified without unreasonable effort or expense; and (iii) can be transferred in compliance with any Laws or Contracts applicable to such data or samples.

(d) Buyer and Seller shall cooperate and work together to ensure that the attorney-client privilege is preserved with respect to any documents in the Business Books and Records that are subject to such privilege (and any other documents, information, or materials that are subject to such privilege and may be transferred from or disclosed by one party to the other under this Agreement).

Section 6.19 Trademark Filing. Within five (5) Business Days after the Closing Date, Seller shall file with the United States Patent and Trademark Office a “Surrender of Registration for Cancellation” request with respect to U.S. Registration No. 5,063,055 for the mark ONCOTYPE DX GENOMIC PROSTATE SCORE.

Section 6.20 VA Arrangement. From and after the Closing Date until the earlier of: (a) December 31, 2022, (b) the date on which the GPS Test is added to the Buyer’s Federal Supply Schedule and (to the extent required for Buyer to offer the GPS Test under the Federal Supply Schedule) GHI is accepted as a subcontractor for the GPS Test under MDx’s Federal Supply Schedule, or (c) a date agreed upon in a writing signed by parties, Seller shall continue to perform the GPS Test pursuant to open orders and awards existing as of the Closing Date that were issued by the VA for the performance of the GPS Test, in substantially the same manner as Seller has performed such services for the VA immediately prior to the Closing Date (the “VA Arrangement”). Subject to the VA License Agreement, Seller shall be entitled to all revenue generated in respect of the VA Arrangement.

Article VII

[INTENTIONALLY OMITTED]

Article VIII

INDEMNIFICATION

Section 8.01 Survival. Subject to the limitations and other provisions of this Agreement, the representations and warranties of the parties shall terminate upon the Closing. Notwithstanding the foregoing, any claims asserted in good faith with reasonable specificity (to the extent known at such time) and in writing by notice from the non-breaching party to the breaching party prior to the expiration date of the applicable survival period shall not thereafter be barred by the expiration of the relevant representation or warranty and such claims shall survive until finally resolved. The covenants of the parties set forth in this Agreement to be performed after the Closing shall survive the Closing in accordance with their respective terms. For the avoidance of doubt, nothing in this Section 8.01 shall affect the time periods during which any indemnification claim may be made under the R&W Insurance Policy.

Section 8.02 Indemnification by Seller. From and after Closing, subject to the other terms and conditions of this ARTICLE VIII, Seller shall indemnify and defend each of Buyer and its Affiliates and their respective Representatives (collectively, the “Buyer Indemnitees”) against, and shall hold each of them harmless from and against, and shall pay and reimburse each of them for, any and all Losses actually incurred or sustained by, or imposed upon, the Buyer Indemnitees to the extent, arising out of or relating to:

(a) any breach or non-fulfillment of any covenant or agreement to be performed by Seller pursuant to this Agreement; or

(b) any Excluded Asset or any Excluded Liability.

Section 8.03 Limitationson Indemnification by Seller. With respect to any Losses arising out of or relating to any inaccuracy in or breach of any of the representations or warranties of Seller contained in this Agreement, the Ancillary Documents or in any certificate or instrument delivered by or on behalf of Seller pursuant to this Agreement, the sole and exclusive remedy shall be the R&W Insurance Policy.

Section 8.04 Indemnification By Buyer. From and after Closing, subject to the other terms and conditions of this ARTICLE VIII, Buyer shall indemnify and defend each of Seller and its Affiliates and their respective Representatives (collectively, the “Seller Indemnitees”) against, and shall hold each of them harmless from and against, and shall pay and reimburse each of them for, any and all Losses incurred or sustained by, or imposed upon, the Seller Indemnitees to the extent, arising out of:

(a) any breach or non-fulfillment of any covenant, agreement or obligation to be performed by Buyer pursuant to this Agreement; or

(b) any Purchased Assets (only to the extent arising out of or relating to the ownership, sale, use or lease of the Purchased Assets after Closing) or Assumed Liabilities.

Section 8.05 Indemnification Procedures. The party making a claim under this ARTICLE VIII is referred to as the “Indemnified Party”, and the party against whom such claims are asserted under this ARTICLE VIII is referred to as the “Indemnifying Party”.

(a) Third Party Claims. If any Indemnified Party receives notice of the assertion or commencement of any Action made or brought by any Person who is not a party to this Agreement or an Affiliate of a party to this Agreement or a Representative of the foregoing (a “Third Party Claim”) against such Indemnified Party with respect to which the Indemnifying Party is obligated to provide indemnification under this Agreement, the Indemnified Party shall give the Indemnifying Party reasonably prompt written notice thereof, but in any event not later than 30 calendar days after receipt of such notice of such Third Party Claim. The failure or delay to give such prompt written notice shall not, however, relieve the Indemnifying Party of its indemnification obligations, except and only to the extent that the Indemnifying Party is actually prejudiced by reason of such delay or failure. Such notice by the Indemnified Party shall describe the Third Party Claim in reasonable detail, shall include copies of all material written evidence thereof and shall indicate the estimated amount, if reasonably practicable, of the Loss that has been or may be sustained by the Indemnified Party. The Indemnifying Party shall have the right to participate in, or by giving written notice to the Indemnified Party within 30 days of receiving notice thereof, to assume the defense of any Third Party Claim at the Indemnifying Party’s expense and by the Indemnifying Party’s own counsel; provided, that if the Indemnifying Party is Seller, such Indemnifying Party shall not have the right to defend or direct the defense of any such Third Party Claim that (x) is asserted directly by or on behalf of a Person that is a supplier or customer of the Business, or (y) seeks an injunction or other equitable relief against the Indemnified Party. If the Indemnifying Party assumes the defense of any Third Party Claim, the Indemnified Party shall reasonably cooperate with the Indemnifying Party in such defense and make available to the Indemnifying Party (at the Indemnifying Party’s sole cost and expense) all witnesses, pertinent records, materials and information in the Indemnified Party’s possession or under the Indemnified Party’s control relating thereto as is reasonably required by the Indemnifying Party. So long as the Indemnifying Party is conducting the defense of the Third Party Claim in accordance with this Section 8.05(a), the Indemnifying Party will not be responsible for any attorneys’ fees incurred by the Indemnified Party regarding the Third Party Claim (other than attorneys’ fees incurred prior to the Indemnifying Party’s assumption of the defense). In the event that the Indemnifying Party assumes the defense of any Third Party Claim, subject to Section 8.05(b), it shall have the right to take such action as it deems necessary to avoid, dispute, defend, appeal or make counterclaims pertaining to any such Third Party Claim in the name and on behalf of the Indemnified Party. The Indemnified Party shall have the right to participate in the defense of any Third Party Claim with counsel selected by it subject to the Indemnifying Party’s right to control the defense thereof. The fees and disbursements of such counsel shall be at the expense of the Indemnified Party, provided,that if in the reasonable opinion of counsel to the Indemnified Party, (A) there are legal defenses available to an Indemnified Party that are different from or additional to those available to the Indemnifying Party; or (B) there exists a conflict of interest between the Indemnifying Party and the Indemnified Party that cannot be waived, the Indemnifying Party shall be liable for the reasonable fees and expenses of counsel to the Indemnified Party in each jurisdiction for which the Indemnified Party determines counsel is required. If the Indemnifying Party elects not to compromise or defend such Third Party Claim, or fails to within 30 days notify the Indemnified Party in writing of its election to defend as provided in this Agreement, the Indemnified Party may, subject to Section 8.05(b), pay, compromise, defend such Third Party Claim and seek indemnification for any and all Losses based upon, arising from or relating to such Third Party Claim. Seller and Buyer shall cooperate with each other in all reasonable respects in connection with the defense of any Third Party Claim, including making available (subject to the provisions of Section 6.06) records relating to such Third Party Claim and furnishing, without expense (other than reimbursement of actual out-of-pocket expenses) to the defending party, management employees of the non-defending party as may be reasonably necessary for the preparation of the defense of such Third Party Claim.

(b) Settlement of Third Party Claims. Notwithstanding any other provision of this Agreement, the neither the Indemnifying Party nor the Indemnified Party shall enter into settlement of any Third Party Claim without the prior written consent of the other, except as provided in this Section 8.05(b). If a firm offer is made to settle a Third Party Claim without leading to liability or the creation of a financial or other obligation on the part of the Indemnified Party and provides, in customary form, for the unconditional release of each Indemnified Party from all liabilities and obligations in connection with such Third Party Claim and the Indemnifying Party desires to accept and agree to such offer, the Indemnifying Party shall give written notice to that effect to the Indemnified Party. If the Indemnified Party fails to consent to such firm offer within ten days after its receipt of such notice, the Indemnified Party may continue to contest or defend such Third Party Claim and in such event, the maximum liability of the Indemnifying Party as to such Third Party Claim shall not exceed the amount of such settlement offer. If the Indemnified Party fails to consent to such firm offer and also fails to assume defense of such Third Party Claim, the Indemnifying Party may settle the Third Party Claim upon the terms set forth in such firm offer to settle such Third Party Claim. If the Indemnified Party has assumed the defense pursuant to Section 8.05(a), it shall not agree to any settlement without the written consent of the Indemnifying Party (which consent shall not be unreasonably withheld, conditioned or delayed).

(c) Direct Claims. Any Action by an Indemnified Party on account of a Loss which does not result from a Third Party Claim (a “Direct Claim”) shall be asserted by the Indemnified Party giving the Indemnifying Party reasonably prompt written notice thereof, but in any event not later than 30 days after the Indemnified Party becomes aware of such Direct Claim. The failure to give such prompt written notice shall not, however, relieve the Indemnifying Party of its indemnification obligations, except and only to the extent that the Indemnifying Party is actually prejudiced by reason of such delay or failure. Such notice by the Indemnified Party shall describe the Direct Claim in reasonable detail, shall include copies of all material written evidence thereof and shall indicate the estimated amount, if reasonably practicable, of the Loss that has been or may be sustained by the Indemnified Party. The Indemnifying Party shall have 60 days after its receipt of such notice to respond in writing to such Direct Claim. The Indemnified Party shall allow the Indemnifying Party and its professional advisors to investigate the matter or circumstance alleged to give rise to the Direct Claim, and whether and to what extent any amount is payable in respect of the Direct Claim and the Indemnified Party shall assist the Indemnifying Party’s investigation by giving such information and assistance (including access to the Indemnified Party’s premises and personnel and the right to examine and copy any accounts, documents or records) as the Indemnifying Party or any of its professional advisors may reasonably request. If the Indemnifying Party does not so respond within such 60 day period, the Indemnifying Party shall be deemed to have rejected such claim (without waiving any available rights, remedies, defenses or counterclaims in respect of such Direct Claim), in which case the Indemnified Party shall be free to pursue such remedies as may be available to the Indemnified Party on the terms and subject to the provisions of this Agreement.

Section 8.06 Payments.

(a) Once a Loss is agreed to by the Indemnifying Party or finally adjudicated to be payable pursuant to this ARTICLE VIII, the Indemnifying Party shall satisfy its obligations within five (5) Business Days of such final, non-appealable adjudication by wire transfer of immediately available funds.

Section 8.07 Tax Treatment of Indemnification Payments. All indemnification payments made under this Agreement shall be treated by the parties as an adjustment to the Purchase Price for Tax purposes, unless otherwise required by Law.

Section 8.08 Exclusive Remedies. Subject to Section 2.08, Section 6.07 and Section 10.11, the parties acknowledge and agree that their sole and exclusive remedy with respect to any and all claims (other than claims arising from fraud, criminal activity or willful misconduct on the part of a party hereto in connection with the transactions contemplated by this Agreement) for any breach of any representation, warranty, covenant, agreement or obligation set forth herein or otherwise relating to the subject matter of this Agreement, shall be pursuant to the indemnification provisions set forth in this ARTICLE VIII. In furtherance of the foregoing, each party hereby waives, to the fullest extent permitted under Law, any and all rights, claims and causes of action for any breach of any representation, warranty, covenant, agreement or obligation set forth herein or otherwise relating to the subject matter of this Agreement it may have against the other parties hereto and their Affiliates and each of their respective Representatives arising under or based upon any Law, except pursuant to the indemnification provisions set forth in this ARTICLE VIII. Nothing in this Section 8.08 shall limit any Person’s right to seek and obtain any equitable relief to which any Person shall be entitled or to seek any remedy on account of any party’s fraudulent, criminal or intentional misconduct.

Notwithstanding anything to the contrary contained herein, no limitations (including any survival limitations and other limitations set forth in this ARTICLE VIII), qualifications or procedures in this Agreement shall be deemed to limit or modify the ability of Buyer to make claims under or recover under the R&W Insurance Policy; it being understood that any matter for which there is coverage available under the R&W Insurance Policy shall be subject to the terms, conditions and limitations, if any, set forth in the R&W Insurance Policy.

Article IX

[INTENTIONALLY OMITTED]

Article X

MISCELLANEOUS

Section 10.01 Expenses. Except as otherwise expressly provided herein, all costs and expenses, including, without limitation, fees and disbursements of counsel, financial advisors and accountants, incurred in connection with this Agreement and the transactions contemplated hereby and thereby shall be paid by the party incurring such costs and expenses, whether or not the Closing shall have occurred; provided, however, Buyer and Seller shall be equally responsible for all filing and other similar fees payable in connection with any filings or submissions under the HSR Act, if applicable.

Section 10.02 Notices. All notices, requests, consents, claims, demands, waivers and other communications hereunder shall be in writing and shall be deemed to have been given (a) when delivered by hand (with written confirmation of receipt); (b) when received by the addressee if sent by a nationally recognized overnight courier (receipt requested); (c) on the date sent by facsimile or e-mail of a PDF document (with confirmation of transmission) if sent during normal business hours of the recipient, and on the next Business Day if sent after normal business hours of the recipient or (d) on the third day after the date mailed, by certified or registered mail, return receipt requested, postage prepaid. Such communications must be sent to the respective parties at the following addresses (or at such other address for a party as shall be specified in a written notice given in accordance with this Section 10.02):

If to Seller:	Genomic Health, Inc.<br><br> <br>5505 Endeavour Lane<br><br> <br>Madison, WI 53719<br><br> <br>Attention: General Counsel<br><br> <br>E-mail: [***]
with a copy to (which shall not constitute notice):	K&L Gates LLP<br><br> <br>300 S. Tryon Street, Suite 1000<br><br> <br>Charlotte, NC 28202<br><br> <br>Attn: John E. Blair, Jr.<br><br> <br>Email: [***]

If to Buyer:	MDxHealth SA<br><br> <br>15279 Alton Parkway<br><br> <br>Suite 100<br><br> <br>Irvine, CA 92618<br><br> <br>Attention: General Counsel<br><br> <br>E-mail: [***]
with a copy to (which shall not constitute notice):	Foley Hoag LLP<br><br> <br>155 Seaport Boulevard<br><br> <br>Boston, MA 02210<br><br> <br>Attention: Jeffrey L. Quillen; Daniel S. Clevenger<br><br> <br>E-mail: [***]

Section 10.03 Interpretation. For purposes of this Agreement, (a) the words “include,” “includes” and “including” shall be deemed to be followed by the words “without limitation”; (b) the word “or” is not exclusive; and (c) the words “herein,” “hereof,” “hereby,” “hereto” and “hereunder” refer to this Agreement as a whole, including Exhibits, annexes, and the Disclosure Schedules, and not to any particular provision, section, or subsection. Unless the context otherwise requires, references herein: (x) to Articles, Sections, Disclosure Schedules and Exhibits mean the Articles and Sections of, and Disclosure Schedules and Exhibits attached to, this Agreement; (y) to an agreement, instrument or other document means such agreement, instrument or other document as amended, supplemented and modified from time to time to the extent permitted by the provisions thereof and (z) to a statute means such statute as amended from time to time and includes any successor legislation thereto and any regulations promulgated thereunder. This Agreement shall be construed without regard to any presumption or rule requiring construction or interpretation against the party drafting an instrument or causing any instrument to be drafted. The Disclosure Schedules and Exhibits referred to herein shall be construed with, and as an integral part of, this Agreement to the same extent as if they were set forth verbatim herein. When calculating the period of time before which, within which or following which, any act is to be done or step taken under this Agreement, the date that is the reference date in calculating such period will be excluded. If the last day of such period is a non-Business Day, the period in question will end on the next succeeding Business Day. Any item disclosed on any Disclosure Schedule to this Agreement shall be deemed disclosed and incorporated by reference in any other section of this Agreement as though fully set forth in such other section of the Disclosure Schedules to the extent that it is reasonably apparent from the face of such disclosure that such disclosure would apply to such other section of the Disclosure Schedules.

Section 10.04 Headings. The headings in this Agreement are for reference only and shall not affect the interpretation of this Agreement.

Section 10.05 Severability. If any term or provision of this Agreement is determined by a court of competent jurisdiction to be invalid, illegal or unenforceable in any jurisdiction, such invalidity, illegality or unenforceability shall not affect any other term or provision of this Agreement or invalidate or render unenforceable such term or provision in any other jurisdiction. Except as provided in Section 6.07(e), upon such determination that any term or other provision is invalid, illegal or unenforceable, the parties hereto shall negotiate in good faith to modify this Agreement so as to effect the original intent of the parties as closely as possible in a mutually acceptable manner in order that the transactions contemplated hereby be consummated as originally contemplated to the greatest extent possible.

Section 10.06 Entire Agreement. This Agreement and the Ancillary Documents constitute the sole and entire agreement of the parties to this Agreement with respect to the subject matter contained herein and therein, and supersede all prior and contemporaneous understandings and agreements, both written and oral, with respect to such subject matter. In the event of any inconsistency between the statements in the body of this Agreement and those in the Ancillary Documents, the Exhibits and Disclosure Schedules (other than an exception expressly set forth as such in the Disclosure Schedules), the statements in the body of this Agreement will control, except where an Ancillary Document expressly provides otherwise.

Section 10.07 Successors and Assigns. This Agreement shall be binding upon and shall inure to the benefit of the parties hereto and their respective successors and permitted assigns. Neither party may assign its rights or obligations hereunder without the prior written consent of the other party, which consent shall not be unreasonably withheld, conditioned or delayed; provided, however, that prior to the Closing Date, Buyer may, without the prior written consent of Seller, assign all or any portion of its rights under this Agreement to one or more of its direct or indirect wholly-owned subsidiaries, and Buyer may grant security over its rights under this Agreement to its lenders. No assignment shall relieve the assigning party of any of its obligations hereunder.

Section 10.08 No Third-party Beneficiaries. Except as provided in ARTICLE VIII, this Agreement is for the sole benefit of the parties hereto and their respective successors and permitted assigns and nothing herein, express or implied, is intended to or shall confer upon any other Person or entity any legal or equitable right, benefit or remedy of any nature whatsoever under or by reason of this Agreement.

Section 10.09 Amendment and Modification; Waiver. This Agreement may only be amended, modified or supplemented by an agreement in writing signed by each party hereto. No waiver by any party of any of the provisions hereof shall be effective unless explicitly set forth in writing and signed by the party so waiving. No waiver by any party shall operate or be construed as a waiver in respect of any failure, breach or default not expressly identified by such written waiver, whether of a similar or different character, and whether occurring before or after that waiver. No failure to exercise, or delay in exercising, any right, remedy, power or privilege arising from this Agreement shall operate or be construed as a waiver thereof; nor shall any single or partial exercise of any right, remedy, power or privilege hereunder preclude any other or further exercise thereof or the exercise of any other right, remedy, power or privilege.

Section 10.10 Governing Law; Submission to Jurisdiction; Waiver of Jury Trial.

(a) This Agreement shall be governed by and construed in accordance with the internal laws of the State of Delaware without giving effect to any choice or conflict of law provision or rule (whether of the State of Delaware or any other jurisdiction) that would cause the application of the Law of any jurisdiction other than the State of Delaware.

(b) ANY LEGAL SUIT, ACTION OR PROCEEDING ARISING OUT OF OR BASED UPON THIS AGREEMENT, THE ANCILLARY DOCUMENTS OR THE TRANSACTIONS CONTEMPLATED HEREBY OR THEREBY MAY BE INSTITUTED IN THE DELAWARE COURT OF CHANCERY OR, IN THE EVENT THAT SUCH COURT DOES NOT HAVE SUBJECT MATTER JURISDICTION OVER SUCH ACTION OR PROCEEDING, IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE, AND EACH PARTY IRREVOCABLY SUBMITS TO THE EXCLUSIVE JURISDICTION OF SUCH COURTS IN ANY SUCH SUIT, ACTION OR PROCEEDING. SERVICE OF PROCESS, SUMMONS, NOTICE OR OTHER DOCUMENT BY MAIL TO SUCH PARTY’S ADDRESS SET FORTH HEREIN SHALL BE EFFECTIVE SERVICE OF PROCESS FOR ANY SUIT, ACTION OR OTHER PROCEEDING BROUGHT IN ANY SUCH COURT. THE PARTIES IRREVOCABLY AND UNCONDITIONALLY WAIVE ANY OBJECTION TO THE LAYING OF VENUE OF ANY SUIT, ACTION OR ANY PROCEEDING IN SUCH COURTS AND IRREVOCABLY WAIVE AND AGREE NOT TO PLEAD OR CLAIM IN ANY SUCH COURT THAT ANY SUCH SUIT, ACTION OR PROCEEDING BROUGHT IN ANY SUCH COURT HAS BEEN BROUGHT IN AN INCONVENIENT FORUM.

(c) EACH PARTY ACKNOWLEDGES AND AGREES THAT ANY CONTROVERSY WHICH MAY ARISE UNDER THIS AGREEMENT OR THE ANCILLARY DOCUMENTS IS LIKELY TO INVOLVE COMPLICATED AND DIFFICULT ISSUES AND, THEREFORE, EACH SUCH PARTY IRREVOCABLY AND UNCONDITIONALLY WAIVES ANY RIGHT IT MAY HAVE TO A TRIAL BY JURY IN RESPECT OF ANY LEGAL ACTION ARISING OUT OF OR RELATING TO THIS AGREEMENT, THE ANCILLARY DOCUMENTS OR THE TRANSACTIONS CONTEMPLATED HEREBY OR THEREBY. EACH PARTY TO THIS AGREEMENT CERTIFIES AND ACKNOWLEDGES THAT (A) NO REPRESENTATIVE OF ANY OTHER PARTY HAS REPRESENTED, EXPRESSLY OR OTHERWISE, THAT SUCH OTHER PARTY WOULD NOT SEEK TO ENFORCE THE FOREGOING WAIVER IN THE EVENT OF A LEGAL ACTION, (B) SUCH PARTY HAS CONSIDERED THE IMPLICATIONS OF THIS WAIVER, (C) SUCH PARTY MAKES THIS WAIVER VOLUNTARILY, AND (D) SUCH PARTY HAS BEEN INDUCED TO ENTER INTO THIS AGREEMENT BY, AMONG OTHER THINGS, THE MUTUAL WAIVERS AND CERTIFICATIONS IN THIS SECTION 10.10(c).

Section 10.11 No Recourse; Prevailing Party.

(a) Notwithstanding anything that may be expressed or implied in this Agreement, each of the parties agrees and acknowledges that no recourse under this Agreement or any documents or instruments delivered in connection with this Agreement shall be had against any current or future director, officer, employee, manager, member, stockholder or Person in a similar position of Seller, Buyer, or of any Affiliate or assignee thereof, as such, whether by the enforcement of any assessment or by any legal or equitable proceeding, or by virtue of any statute, regulation or other applicable Law, it being expressly agreed and acknowledged that no personal liability whatsoever shall attach to, be imposed on or otherwise be incurred by any current or future director officer, employee, manager, member, stockholder or Person in a similar position of Seller, Buyer, or of any Affiliate or assignee thereof, as such, for any obligation of Seller or Buyer under this Agreement or any documents or instruments delivered in connection with this Agreement for any claim based on, in respect of or by reason of such obligations or their creation.

(b) In the event any Action is commenced or threatened by any party (the “Claiming Party”) hereto to enforce its rights under this Agreement against any other party (the “Defending Party”), if the Defending Party is the prevailing party in such Action, all fees, costs and expenses, including, without limitation, reasonable attorneys’ fees and court costs, incurred by the Defending Party in such Action shall be reimbursed by the Claiming Party; provided, that if the Defending Party prevails in part, and loses in part, in such Action, the court, arbitrator or other adjudicator presiding over such Action shall award a reimbursement of the fees, costs and expenses incurred by the Defending Party on an equitable basis. For purposes hereof, and without limitation, the Defending Party shall be deemed to have prevailed in any Action described in the immediately preceding sentence if the Claiming Party commences or threatens any such Action and (i) such underlying claim(s) are dropped, voluntarily dismissed or voluntarily reduced and/or (ii) Defending Party defeats any such claim(s).

Section 10.12 Specific Performance. The parties agree that irreparable damage would occur if any provision of this Agreement were not performed in accordance with the terms hereof and that the parties shall be entitled to specific performance of the terms hereof, in addition to any other remedy to which they are entitled at law or in equity.

Section 10.13 Counterparts. This Agreement may be executed in counterparts, each of which shall be deemed an original, but all of which together shall be deemed to be one and the same agreement. A signed copy of this Agreement delivered by facsimile, e-mail or other means of electronic transmission shall be deemed to have the same legal effect as delivery of an original signed copy of this Agreement.

[SIGNATURE PAGE FOLLOWS]

IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed as of the date first written above by their respective officers thereunto duly authorized.

GENOMIC HEALTH, INC.
By	/s/ Kevin Conroy
Name:	Kevin Conroy
Title:	Chief Executive Officer
MDXHEALTH SA
By	/s/ Michael K. McGarrity
Name:	Michael K. McGarrity
Title:	Chief Executive Officer

[Signature Page to Asset Purchase Agreement]

Exhibit B

Form of Bill of Sale

BILL OF SALE

Genomic Health, Inc., a Delaware corporation (“Seller”), for good and valuable consideration, the receipt, adequacy and legal sufficiency of which are hereby acknowledged, does hereby grant, sell, assign, transfer, convey and deliver to MDxHealth SA, a limited liability company (société anonyme) organized and existing under the laws of Belgium (“Buyer”), its successors and assigns forever, all of Seller’s right, title and interest in, to and under all of the tangible personal property included in the Purchased Assets, in each case free and clear of all Encumbrances except the Permitted Encumbrances, to have and to hold the same unto Buyer, its successors and assigns, forever. Capitalized terms used and not otherwise defined herein shall have the meaning ascribed in the Asset Purchase Agreement between Seller and Buyer, dated as of August 2, 2022 (the “Purchase Agreement”).

Notwithstanding anything herein to the contrary, the provisions of this Bill of Sale shall be subject to and governed by the provisions of the Purchase Agreement, including, without limitation, the representations, warranties, covenants, agreements and indemnities, which are incorporated herein by this reference. If and to the extent the provisions of this Bill of Sale are inconsistent in any way with the provisions of the Purchase Agreement, the provisions of the Purchase Agreement shall be controlling. Nothing contained herein shall be deemed to alter, modify, expand or diminish the terms and provisions set forth in the Purchase Agreement. Nothing contained in this Bill of Sale may be construed as a waiver of any of the rights or remedies set forth in, or arising in connection with, the Purchase Agreement or any other instrument or document delivered pursuant to the Purchase Agreement.

No supplement, modification or amendment of this Bill of Sale shall be binding unless executed in writing by Buyer and Seller. Upon the terms and subject to the conditions set forth in the Purchase Agreement, Buyer and Seller agree to use all reasonable efforts to execute or deliver any additional instruments necessary to consummate the transactions contemplated by, and to fully carry out the purposes of, this Bill of Sale. If any provision of this Bill of Sale or the application of any provision of this Bill of Sale to any party or circumstance is, to any extent, adjudged invalid or unenforceable, the application of the remainder of such provision to such party or circumstance, the application of such provision to other parties or circumstances, and the application of the remainder of this Bill of Sale shall not be affected thereby.

This Bill of Sale shall be governed by and construed in accordance with the internal laws of the State of Delaware without giving effect to any choice or conflict of law provision or rule (whether of the State of Delaware or any other jurisdiction).

* * * *

IN WITNESS WHEREOF, the undersigned have executed this Bill of Sale as of August 2, 2022.

GENOMIC HEALTH, INC.
By:
Name:
Title:
MDxHEALTH SA
By:
Name:
Title:

[Signature Page to Bill of Sale]

Exhibit C

Form of Assignment and Assumption Agreement

[Signature Page to Assignment and AssumptionAgreement]

ExecutionCopy

ASSIGNMENT AND ASSUMPTION AGREEMENT

THIS ASSIGNMENT AND ASSUMPTIONAGREEMENT (this “Agreement”), dated August 2, 2022, is made by and between (i) Genomic Health, Inc., a Delaware corporation (the “Assignor”) and (ii) MDxHealth SA, a limited liability company (société anonyme) organized and existing under the laws of Belgium (“Buyer” and, together with any other transferee entity designated by Buyer, “Assignee”). Capitalized terms used but not otherwise defined in this Agreement shall have the meanings assigned to them in the Asset Purchase Agreement (as defined below).

WHEREAS, the Assignor and Assignee are parties to that certain Asset Purchase Agreement dated as of August 2, 2022 (the “Asset Purchase Agreement”);

WHEREAS, pursuant to the Asset Purchase Agreement, the Assignor has agreed to sell, assign, transfer, convey, and deliver to Assignee all of such Assignor’s right, title, benefit, and interest in, to and under the Purchased Assets (including, without limitation, all of such Assignor’s right, title, benefit, and interest in, to and under the Assigned Contracts, but excluding the Excluded Assets and Excluded Contracts, if any);

WHEREAS, Assignee is assuming and agreeing to pay, perform and discharge only the Assumed Liabilities, and the Assignor is retaining the Excluded Liabilities, as applicable; and

WHEREAS, the execution and delivery of this Agreement by Assignor and Assignee is required under Sections 3.02(a)(ii) and 3.02(b)(iv), respectively, of the Asset Purchase Agreement.

NOW, THEREFORE, in exchange for the consideration provided under the Asset Purchase Agreement and in consideration of the mutual premises set forth herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties agree as follows:

1. Effective as of the Closing and upon the terms and subject to the conditions set forth in this Agreement and the Asset Purchase Agreement, the Assignor hereby irrevocably and unconditionally sells, assigns, transfers, conveys, delivers, and sets over to Assignee, free and clear of all liens, all of Assignor’s right, title benefit, and interest in, to, and under the Purchased Assets (including, without limitation, the Assigned Contracts). Assignee hereby accepts the sale, transfer, assignment, conveyance, and delivery of all of Assignor’s right, title, and interest in, to, and under the Purchased Assets (including, without limitation, the Assigned Contracts, but excluding the Excluded Assets and Excluded Contracts, if any).

2. Effective as of the Closing and upon the terms and subject to the conditions set forth in the Asset Purchase Agreement, the Assignor hereby assigns, transfers and conveys to Assignee, and the Assignee hereby accepts such assignment and shall assume and agrees to pay, perform and discharge the Assumed Liabilities. Assignee shall not assume, and Assignee will not be responsible for and will not be required to pay, perform, or discharge, any Excluded Liabilities of Assignor.

3. This Agreement, and all matters arising out of or relating to this Agreement and any of the transactions contemplated hereby, including the validity hereof and the rights and obligations of the parties hereunder, shall be construed in accordance with and governed by the laws of the State of Delaware, without giving effect to the conflicts of laws provisions thereof.

4. This Agreement may not be amended, waived or terminated except by a writing signed by Assignee and the Assignor.

5. This Agreement may be executed in one or more counterparts, each of which when executed shall be deemed an original, but all of which taken together shall constitute one and the same instrument. A signed copy of this Agreement delivered by e-mail or other means of electronic transmission shall be deemed to have the same legal effect as delivery of an original signed copy of this Agreement.

6. Notwithstanding anything herein to the contrary, the provisions of this Agreement shall be subject to and governed by the provisions of the Asset Purchase Agreement, including, without limitation, the representations, warranties, covenants, agreements and indemnities, which are incorporated herein by this reference. If and to the extent the provisions of this Agreement are inconsistent in any way with the provisions of the Asset Purchase Agreement, the provisions of the Asset Purchase Agreement shall be controlling. Nothing contained herein shall be deemed to alter, modify, expand or diminish the terms and provisions set forth in the Asset Purchase Agreement. Nothing contained in this Agreement may be construed as a waiver of any of the rights or remedies set forth in, or arising in connection with, the Asset Purchase Agreement or any other instrument or document delivered pursuant to the Asset Purchase Agreement.

7. Neither this Agreement nor any of the rights, interests and obligations hereunder shall be assigned by either of the parties hereto without the prior written consent of the other party; provided, that, notwithstanding the foregoing, this Agreement and a party’s rights, interests or obligations hereunder may be assigned in the same manner permitted for assignments of such party’s rights or obligations under the Asset Purchase Agreement. Subject to the preceding sentence, this Agreement will be binding upon, inure to the benefit of and be enforceable by the parties and their respective successors and permitted assigns.

8. Each of the parties hereto covenant and agree to take such actions and do such things as the other party hereto reasonably requests to execute and deliver, or cause to be executed and delivered, all such additional documents, instruments, conveyances, agreements, and assurances and take such further actions as such other party may reasonably request to carry out evidencing or confirming the sale, assignment, transfer, conveyance, delivery, and set over to Assignee of the Purchased Assets (including the Assigned Contracts).

[Signature Page Follows]

IN WITNESS WHEREOF, the parties hereto have executed this Assignment and Assumption Agreement as of the date first set forth above.

ASSIGNOR:
GENOMIC HEALTH, INC.
By:
Name:
Title:
ASSIGNEE:
MDXHEALTH SA
By:
Name:
Title:

[Signature Page to Assignment and AssumptionAgreement]

Exhibit D

Business Intellectual Property Assignments

ExecutionCopy

PATENT ASSIGNMENT

This Patent Assignment (“PatentAssignment”), dated as of August 2, 2022, is made by Genomic Health, Inc., a Delaware corporation (“Assignor”), in favor of MDxHealth SA, a limited liability company (société anonyme) organized and existing under the laws of Belgium) (“Assignee”), as the transferee of certain intellectual property assets of Assignor pursuant to the Asset Purchase Agreement between Assignor and Assignee dated as of the date hereof (the “Asset Purchase Agreement”).

WHEREAS, under the terms of the Asset Purchase Agreement, Assignor has conveyed, transferred and assigned to Assignee, among other assets, Assignor's right, title and interest in and to the patents and patent applications set forth on Schedule 1 hereto to Assignee, and has agreed to execute and deliver this Patent Assignment, for recording with the United States Patent and Trademark Office and corresponding entities or agencies in any applicable jurisdictions.

NOW THEREFORE, in consideration of the foregoing and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties agree as follows:

1. Assignment. Assignor hereby irrevocably conveys, transfers, and assigns to Assignee, and Assignee hereby accepts, all of Assignor’s right, title, and interest in and to the following (collectively, the “Assigned Patents”):

(a) the patents and patent applications set forth on Schedule 1 hereto and all issuances, divisions, continuations, continuations-in-part, reissues, extensions, reexaminations, and renewals thereof (the “Patents”);

(b) all rights of any kind whatsoever of Assignor accruing under any of the foregoing provided by applicable law of any jurisdiction, by international treaties and conventions, and otherwise throughout the world;

(c) any and all royalties, fees, income, payments, and other proceeds now or hereafter due or payable with respect to any and all of the foregoing; and

(d) any and all claims and causes of action with respect to any of the foregoing, whether accruing before, on, or after the date hereof, including all rights to and claims for damages, restitution, and injunctive and other legal and equitable relief for past, present, and future infringement, dilution, misappropriation, violation, misuse, breach, or default, with the right but no obligation to sue for such legal and equitable relief and to collect, or otherwise recover, any such damages.

2. Recordationand Further Actions. Assignor hereby authorizes the Commissioner for Patents in the United States Patent and Trademark Office and the officials of corresponding entities or agencies in any applicable jurisdictions to record and register this Patent Assignment upon request by Assignee. Following the date hereof, upon Assignee’s reasonable request, Assignor shall take such steps and actions, and provide such cooperation and assistance to Assignee and its successors, assigns, and legal representatives, including the execution and delivery of any affidavits, declarations, oaths, exhibits, assignments, powers of attorney, or other documents, as may be reasonably necessary to effect, evidence, or perfect the assignment of the Assigned Patents to Assignee, or any assignee or successor thereto.

3. Termsof the Asset Purchase Agreement. The parties hereto acknowledge and agree that this Patent Assignment is entered into pursuant to the Asset Purchase Agreement, to which reference is made for a further statement of the rights and obligations of Assignor and Assignee with respect to the Assigned Patents. In the event of any conflict or inconsistency between the terms of the Asset Purchase Agreement and the terms in this Patent Assignment, the terms of the Asset Purchase Agreement shall govern.

4. Counterparts. This Patent Assignment may be executed in counterparts, each of which shall be deemed an original, but all of which together shall be deemed one and the same agreement. A signed copy of this Patent Assignment delivered by facsimile, e-mail, or other means of electronic transmission shall be deemed to have the same legal effect as delivery of an original signed copy of this Patent Assignment.

5. Successorsand Assigns. This Patent Assignment shall be binding upon and shall inure to the benefit of the parties hereto and their respective successors and assigns.

6. GoverningLaw. This Patent Assignment and any claim, controversy, dispute, or cause of action (whether in contract, tort or otherwise) based upon, arising out of, or relating to this Patent Assignment and the transactions contemplated hereby shall be governed by, and construed in accordance with, the laws of the United States and the State of Delaware, without giving effect to any choice or conflict of law provision or rule.

[SIGNATURE PAGE FOLLOWS]

IN WITNESS WHEREOF, Assignor has duly executed and delivered this Patent Assignment as of the date first above written.

Genomic Health, Inc.
Signature:
Name and Title:
Date:

AGREED TO AND ACCEPTED:

MDxHealth SA
Signature:
Name and Title:
Date:

Execution Copy

TRADEMARK ASSIGNMENT

This Trademark Assignment, dated as of August 2, 2022 is made by Genomic Health, Inc. (“Assignor”), a Delaware corporation, in favor of MDxHealth SA (“Assignee”), a limited liability company (société anonyme) organized and existing under the laws of Belgium, the transferee of certain intellectual property assets of Assignor pursuant to the Asset Purchase Agreement between Assignor and Assignee dated as of the date hereof (the “Asset Purchase Agreement”).

WHEREAS, under the terms of the Asset Purchase Agreement, Assignor has conveyed, transferred and assigned to Assignee, among other assets, the trademark(s) and trademark registrations identified on Schedule 1 hereto (collectively, the “Marks”) and has agreed to execute and deliver this Trademark Assignment, for recording with the United States Patent and Trademark Office.

NOW, THEREFORE, in consideration of the foregoing and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties agree as follows:

Assignor hereby irrevocably conveys, transfers, and assigns to Assignee, and Assignee hereby accepts, all of Assignor’s right, title and interest in and to the Marks, together with the goodwill of the business connected with the use of and symbolized by the Marks, and the right to sue and recover for past infringement of the Mark.

[Remainder of Page IntentionallyLeft Blank]

IN WITNESS WHEREOF, Assignor has duly executed and delivered this Trademark Assignment as of the date first above written.

Date:___________________	Assignor:
	Genomic Health, Inc.
	By:
	Name:
	Title:
AGREED TO AND ACCEPTED:
Date: __________________	Assignee:
	MDxHealth SA
	By:
	Name:
	Title:

Schedule 1

Unregistered Marks

GENOMIC PROSTATE SCORE

GPS

Registered Marks

Mark	Country	App. No.		Reg. No.		Classes	Status
GENOMIC PROSTATE SCORE	U.S.		87/917,790		5,719,890	44	Registered
GENOMIC PROSTATE SCORE	U.S.		87/603,919		5,409,364	44	Registered

ExecutionCopy

Exhibit E

Form of Trademark Licensing Agreement

Trademark License Agreement

This Trademark License Agreement (“LicenseAgreement”), between Genomic Health, Inc., a Delaware corporation (“GHI”), Exact Sciences Corporation, a Delaware corporation (“Exact”) (collectively, “Licensors”), and MDxHealth SA, a limited liability company (société anonyme) organized and existing under the laws of Belgium (“MDx” or “Licensee”) is made as of August 2, 2022 (the “Effective Date”). GHI, Exact, and MDx are sometimes referred to herein individually as a “Party” and collectively as the “Parties.” Capitalized terms used but not defined herein will have the meanings ascribed to such terms in the Purchase Agreement (as defined below).

WHEREAS, GHI and MDx are parties to that certain (a) Asset Purchase Agreement of even date herewith (the “Purchase Agreement”), pursuant to which MDx acquired certain business assets related to the Services (as defined below), (b) Transition Services Agreement of even date herewith (the “TransitionServices Agreement”), and (c) Laboratory Services Agreement of even date herewith (the “Laboratory Services Agreement”), pursuant to which GHI agreed to perform, or cause its Affiliates to perform, certain services for MDx on a transitional basis following the Closing;

WHEREAS, the Services are currently provided under trademarks owned by GHI and Exact;

WHEREAS, MDx wishes to use the Licensed Marks (as defined below) on a transitional basis following Closing in connection with the Services (as defined below) in the Territory (as defined below) and GHI and Exact are willing to grant to GHI a license to use the Licensed Marks on the terms and conditions set out in this License Agreement.

NOW, THEREFORE, in consideration of the mutual covenants, terms, and conditions set forth herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties agree as follows:

1. Definitions. For purposes of this License Agreement, the following terms have the following meanings:

“Brand Manual/Use Guidelines” means Licensor's guidelines for the form and manner in which the Licensed Marks may be used under this License Agreement, a copy of which is attached to this License Agreement as Exhibit A, including any amendments or updates to them as Licensor may provide in writing to Licensee from time to time.

“Confidential Information” has the meaning set forth in Section 7.

“Effective Date” has the meaning set forth in the preamble.

“Indemnified Party” has the meaning set forth in Section 9.

“Law” means any statute, law, ordinance, regulation, rule, code, order, constitution, treaty, common law, judgment, award, decree, other requirement, or rule of law of any federal, state, local, or foreign government, or political subdivision thereof, or any arbitrator, court, or tribunal of competent jurisdiction.

“Licensed Marks” means the trademarks set forth on Schedule 1 whether registered or unregistered, including the listed registrations and applications and any registrations which may be granted pursuant to such applications.

“Services” means the services associated with each of the Licensed Marks listed in Schedule 1 for advertising, marketing, distribution, and sale under the Licensed Marks, solely in connection with the performance and analysis of the Oncotype DX Genomic Prostate Score test, as it exists as of the Effective Date.

“Licensee” has the meaning set forth in the preamble and includes any MDx Affiliate.

“Licensors” has the meaning set forth in the preamble.

“Losses” means losses, damages, liabilities, deficiencies, claims, actions, judgments, settlements, interest, awards, penalties, fines, costs, or expenses of whatever kind, including reasonable attorneys' fees and the cost of enforcing any right to indemnification hereunder and the cost of pursuing any insurance providers.

“Person” means an individual, corporation, partnership, joint venture, limited liability company, governmental authority, unincorporated organization, trust, association, or other entity.

“Term” has the meaning set forth in Section 10.1.

“Territory” means the United States of America.

“Third-Party Claim” has the meaning set forth in Section 9.2.

2. License Grant.

2.1 Subject to this License Agreement's terms and conditions, Licensor hereby grants to Licensee during the Term a non-exclusive, non-transferable, non-sublicenseable, royalty free license to use the Licensed Marks on or in connection with the promotion, advertising, provision, and sale of Services in the Territory.

2.2 Reservation of Rights. Licensor hereby reserves all rights not expressly granted to Licensee under this License Agreement. Without limiting the foregoing, all rights granted to Licensee under this License Agreement are subject to Licensor's and its Affiliates' reserved right to use the Licensed Marks in their respective businesses, including in connection with the manufacture, promotion, advertising, distribution, and sale of the Services, or any products or services similar to or competitive with the Services, anywhere in the world.

2.3 Territorial Restrictions. Licensee shall not: (a) conduct advertising incorporating the Licensed Marks in, or specifically aimed at, any country outside the Territory; or (b) actively seek orders using materials bearing the Licensed Marks from outside the Territory.

2.4 Business Names and Domain Names. Licensee shall not use the Licensed Marks (or any mark confusingly similar thereto), individually or in combination, as part of (a) its corporate or trade name, or (b) any domain name.

3. Use of the Licensed Marks.

3.1 Compliance with Licensor's Directions. Licensee shall comply strictly with Licensor's directions regarding the form and manner of the application of the Licensed Marks, including the directions contained in the Brand Manual/Use Guidelines.

3.2 Trademark Notices. Licensee shall ensure that all Services sold or provided by Licensee and all related orders, specifications, marketing materials, descriptive literature, and all other materials carrying the Licensed Marks, be marked with the appropriate trademark notices as set forth in the Brand Manual/Use Guidelines in accordance with Licensors’ instructions.

3.3 Public Announcements. Licensee may issue announcements, statements, press releases, or other publicity or marketing materials during the Term, stating that the GENOMIC PROSTATE SCORE^®^ or GPS^TM^ test (or any name or mark Licensee may select to identify the Test) was formerly known as the ONCOTYPE DX GENOMIC PROSTATE SCORE^®^, ONCOTYPE DX^®^ prostate test, or ONCOTYPE DX GPS^TM^ and was formerly offered by GHI and/or Exact. Following Termination of this License, with the exception of references addressed in Section 3.4 hereof, before issuing any announcements, statements, press releases, or other publicity or marketing materials using the Licensed Marks, Licensee shall seek the prior written consent of Licensors, which shall not be unreasonably withheld or delayed. Following Termination of this License, Licensee shall ensure use of the Licensed Marks conforms to the standards in Sections 3.1, 3.2, 4 and 5 of this License Agreement.

3.4 Ongoing References to Licensed Marks. The Parties acknowledge that the Test is widely known and referred to using the Licensed Marks by third parties, including without limitation health care providers, patients, academic authors, scientific researchers, insurance companies, and publishers of cancer treatment guidelines (such as the National Comprehensive Cancer Network). Licensee shall use reasonable commercial efforts to encourage such parties to cease continuing use of the Licensed Marks in reference to the Test. Licensee may refer to the Licensed Marks, including after Termination of this License, in the context of informing such parties that the Test formerly identified as ONCOTYPE DX GENOMIC PROSTATE SCORE^®^, ONCOTYPE DX^®^ prostate test, ONCOTYPE DX GPS^TM^ or such other derivation used by a third-party publisher, payor or other third party, and formerly offered by GHI and/or Exact, has been rebranded and is offered by Licensee. In addition, Licensee may refer to the Licensed Marks, including after Termination of this License, for the purpose of complying with any legal requirements, including without limitation, to indicate that laboratory testing is being performed by GHI during the effective period of the Reference Laboratory Services Agreement of even date herewith. The Parties acknowledge that the references to the Licensed Marks described in this Paragraph 3.4 are not trademark uses and do not require a license from Licensor.

3.5 Phase-Out of Existing Stock and Materials.

(a) Printed Materials. Following Termination of the License, Licensee shall be permitted to sell through any existing stock of printed materials bearing the Licensed Marks, including without limitation sample transport kits. Following Termination of the License, Licensee shall be permitted to receive and process any printed materials bearing the Licensed Marks, including without limitation any sample transport kits that may be held by customers as of the Termination date.

(b) Audiovisual Materials. Following termination of the License, Licensee shall be permitted to continue displaying any existing audiovisual materials acquired by Licensor pursuant to the Purchase Agreement, including without limitation marketing and educational videos relating to the Test, notwithstanding the fact that such materials may feature the Licensed Marks, until such time as Licensee, in its sole discretion, phases out such materials in the ordinary course of business.

4. Ownership and Registration.

4.1 Acknowledgement of Ownership. Licensee acknowledges that (a) Licensors are the owner of the Licensed Marks and all goodwill related thereto, and (b) all use of the Licensed Marks under this License Agreement and any goodwill accruing from such use will inure solely to Licensors’ benefit. If Licensee acquires any rights in the Licensed Marks, by operation of law or otherwise, Licensee hereby irrevocably assigns such rights to Licensors without further action by any of the parties. Licensee shall not dispute or challenge, or assist any Person in disputing or challenging, Licensors’ rights in and to the Licensed Marks or the Licensed Marks' validity.

4.2 Licensee Restrictions. Licensee agrees that it shall not during the Term or thereafter, directly or indirectly:

(a) take, omit to take, or permit any action which will or may dilute the Licensed Marks or tarnish or bring into disrepute the reputation of or goodwill associated with the Licensed Marks or Licensor, or which will or may invalidate or jeopardize any registration of the Licensed Marks; or

(b) apply for, or obtain, or assist any Person in applying for or obtaining any registration of the Licensed Marks, or any trademark, service mark, trade name, or other indicia confusingly similar to the Licensed Marks in the Territory or elsewhere.

4.3 Maintenance of Registrations. Licensee shall provide, at Licensors’ request and at Licensors’ expense, all necessary assistance with maintenance of existing registrations and prosecution of any pending applications that comprise the Licensed Marks.

4.4 No Encumbrances. Licensee shall not grant or attempt to grant a security interest in, or otherwise encumber, the Licensed Marks or record any such security interest or encumbrance against any application or registration regarding the marks in the United States Patent and Trademark Office or elsewhere.

5. Quality Control.

5.1 Acknowledgement. Licensee acknowledges and is familiar with the high standards, quality, style, and image of Licensor, and Licensee at all times shall conduct its business and use the Licensed Marks in connection with the Services in a manner consistent with these standards, quality, style, and image.

5.2 Compliance with Laws. Licensee shall promptly provide Licensor with copies of all communications with any governmental, regulatory, or industry authority relating to the Licensed Marks.

5.3 New Marketing and Advertising Materials. After the Effective Date, Licensee shall obtain Licensor’s written consent prior to implementing any material changes to advertisements, marketing or promotional material bearing the Licensed Marks. Nothing in this section shall be interpreted to limit the applicability of Section 3.4.

6. Enforcement.

6.1 Notification. Licensee shall immediately notify Licensor in writing with reasonable detail of any: (a) actual, suspected, or threatened infringement of the Licensed Marks, claim that the Licensed Marks are invalid, or opposition to the Licensed Marks; (b) actual, suspected, or threatened claim that use of the Licensed Marks infringes the rights of any third party; (c) Person applying for, or granted, a registered trademark by reason of which that Person may be, or has been, granted rights which conflict with any of the rights granted to Licensee under this License Agreement; or (d) other actual, suspected or threatened claim to which the Licensed Marks may be subject.

6.2 Actions. With respect to any of the matters listed in Section 6.1: (a) Licensor has exclusive control over, and conduct of, all claims and proceedings; (b) Licensee shall provide Licensor, at Licensor’s sole expense, with all assistance that Licensor may reasonably require in the conduct of any claims or proceedings; and (c) Licensor shall bear the cost of any proceedings and will be entitled to retain all sums recovered in any action for its own account.

7. Confidentiality.

7.1 Confidentiality.

(a) Confidential Information. From time to time during the Term, the Parties or their Affiliates may disclose or make available (as the “Disclosing Party”) to another Party or its Affiliates (as the “Receiving Party”) information about the Disclosing Party’s (or the Disclosing Party’s Affiliates’) business or affairs, including information relating to the Business, clinical information, customers, clients, suppliers, vendors, investors, lenders, consultants, independent contractors or employees, price lists and pricing policies, financial statements and information, budgets and projections, business plans, production costs, market research, marketing, sales and distribution strategies, manufacturing techniques, processes and business methods, technical information, pending projects and proposals, new business plans and initiatives, research and development projects, inventions, discoveries, ideas, technologies, trade secrets, know-how, formulae, designs, patterns, marks, names, improvements, industrial designs, mask works, works of authorship and other Intellectual Property, devices, samples, plans, drawings and specifications, photographs and digital images, computer software and programming, the terms of this Agreement, all other confidential information and materials relating to its business or affairs, and all notes, analyses, compilations, studies, summaries, reports, manuals, documents and other materials that ought reasonably to be considered confidential prepared by or for the Disclosing Party (or its Affiliates) containing or based in whole or in part on any of the foregoing, whether in verbal, written, graphic, electronic or any other form, whether or not conceived, developed or prepared in whole or in part by the Disclosing Party and whether or not marked as confidential (collectively, “Confidential Information”).

(b) Exclusions. Confidential Information does not include information that, the Receiving Party can demonstrate: (i) was publicly known to it at the time of disclosure, or has become publicly known through no breach of this Agreement or the Ancillary Documents by Receiving Party or its Representatives; (ii) rightfully obtained by the Receiving Party on a non-confidential basis from a third party that was in lawful possession of such information and not under any obligations of confidentiality regarding such information; or (iii) independently developed by the Receiving Party without reference to or use of any the Disclosing Party’s Confidential Information and that can be demonstrated by the Receiving Party through contemporaneously prepared written records.

(c) Protection of Confidential Information. The Receiving Party will safeguard the Confidential Information from unauthorized use, access, or disclosure using at least the degree of care it uses to protect its confidential information and in no event less than a reasonable degree of care. The Receiving Party may use Confidential Information only for the purposes of fulfilling its obligations under this Agreement and enforcing its rights under this Agreement. The Receiving Party will not disclose the Disclosing Party’s Confidential Information to any Person or entity, except: (a) to the Receiving Party’s employees, Affiliates and subcontractors who have a need to know the Confidential Information for the sole purpose of fulfilling Receiving Party’s obligations under this Agreement and who have been advised of the terms of this Section 8.1 and are bound by written obligations of confidentiality no less restrictive than the obligations of confidentiality herein, (b) as provided for in the Purchase Agreement or Ancillary Documents, or (c) to the limited extent required in order to comply with the order of a court or other Governmental Authority, or as otherwise necessary to comply with applicable Law, provided that the Receiving Party will promptly provide the Disclosing Party with prior written notice so that the Disclosing Party may seek a protective order and provide reasonable assistance to the Disclosing Party in seeking such an order. Receiving Party will be liable for any breach of these confidentiality provisions by its Representatives.

(d) Return or Destruction of Confidential Information. On the expiration or termination of this Agreement or at the Disclosing Party’s written request, the Receiving Party will promptly return to the Disclosing Party all copies, whether in written, electronic, or other form or media, of the Disclosing Party’s Confidential Information, or at Disclosing Party’s written direction destroy all such copies and certify in writing to the Disclosing Party that such Confidential Information has been destroyed. Notwithstanding the foregoing, the Receiving Party may retain a copy of the Disclosing Party’s Confidential Information (a) to the extent and for so long as required by applicable Law, and (b) held electronically in archive or backup systems in accordance with general systems archiving and backup policies; on each condition that, in each instance, all such retained Confidential Information remains subject to the provisions of this Section 7.1.

(e) Survival. The obligations imposed by this Section 7.1 will survive the termination or expiration of this Agreement for five (5) years from the date of such termination or expiration; except with respect to Confidential Information that constitutes trade secrets, which will survive the termination or expiration of this Agreement for so long as the trade secret information is treated as trade secret under applicable Law.

7.2 Specific Performance. The Parties agree and acknowledge that money damages may not be an adequate remedy for any breach of the provisions of this Article 7 (and thus waive any defense that there is an adequate remedy at law), and that any Party may in its sole discretion apply to any court of law or equity of competent jurisdiction for specific performance or injunctive relief (without posting a bond or other security) in order to enforce or prevent any violation or threatened violation of the provisions of this Article 7.

8. Representations and Warranties.

8.1 Mutual Representations and Warranties. Each party represents and warrants to the other party that:

(a) it is duly organized, validly existing, and in good standing as a corporation or other entity as represented herein under the Laws of its jurisdiction of incorporation or organization;

(b) it has the full right, power and authority to enter into this License Agreement and to perform its obligations hereunder;

(c) the execution of this License Agreement by its representative whose signature is set forth at the end hereof has been duly authorized by all necessary corporate/organizational action of the party; and

(d) when executed and delivered by such party, this License Agreement will constitute the legal, valid, and binding obligation of such party, enforceable against such party in accordance with its terms.

8.2 Disclaimer of Representations and Warranties. Nothing in this License Agreement constitutes any representation or warranty by Licensor that:

(a) any Licensed Marks are valid;

(b) any Licensed Marks (if an application) shall proceed to grant or, if granted, shall be valid; or

8.3 Exclusion of Consequential and Other Indirect Damages. TO THE FULLEST EXTENT PERMITTED BY LAW, LICENSOR WILL NOT BE LIABLE TO LICENSEE FOR ANY CONSEQUENTIAL, INCIDENTAL, INDIRECT, EXEMPLARY, SPECIAL, PUNITIVE, OR ENHANCED DAMAGES WHETHER ARISING OUT OF BREACH OF CONTRACT, TORT (INCLUDING NEGLIGENCE), OR OTHERWISE, REGARDLESS OF WHETHER SUCH DAMAGE WAS FORESEEABLE AND WHETHER OR NOT LICENSEE HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

9. Indemnification.

9.1 Indemnification. Licensee shall indemnify, defend, and hold harmless Licensors and their Affiliates, officers, directors, employees, agents, successors, and assigns (each, an “Indemnified Party”), from and against all Losses arising out of or in connection with any third party claim, suit, action, or proceeding (each, a “Third-Party Claim”) relating to any actual or alleged: (a) breach by Licensee of any representation, warranty, covenant, or obligation under this License Agreement; or (b) Licensee's exercise of its rights granted under this License Agreement, except to the extent any such Third-Party Claim is based solely on trademark infringement arising out of Licensee's use of a Licensed Mark in accordance with this License Agreement.

9.2 Indemnification Procedures. The Indemnified Party shall promptly notify the Licensee upon becoming aware of a Third-Party Claim under this Section 9.2. The Licensee shall promptly assume control of the defense and investigation of such Third-Party Claim, with counsel reasonably acceptable to the Indemnified Party, and the Indemnified Party shall reasonably cooperate with the Licensee in connection therewith, in each case at the Licensee's sole cost and expense. The Indemnified Party may participate in the defense of such Third-Party Claim, with counsel of its own choosing and at its own cost and expense. The Licensee shall not settle any such Third-Party Claim on any terms or in any manner that adversely affects the rights of any Indemnified Party without such Indemnified Party's prior written consent (which consent shall not be unreasonably withheld, conditioned, or delayed). If the Licensee fails or refuses to assume control of the defense of such Third-Party Claim, the Indemnified Party has the right, but no obligation, to defend against such Third-Party Claim, including settling such Third-Party Claim after giving notice to the Licensee, in each case in such manner and on such terms as the Indemnified Party may deem appropriate. Neither the Indemnified Party's failure to perform any obligation under this Section 9.2 nor any Indemnified Party's act or omission in the defense or settlement of any such Third-Party Claim will relieve the Licensee of its obligations under this Section 9.2, including with respect to any Losses, except to the extent that the Licensee can demonstrate that it has been materially prejudiced as a result thereof.

10. Term and Termination.

10.1 Term. This License Agreement will commence as of the Effective Date and, unless terminated earlier in accordance with this Section 10, will continue until the expiration of the Wrap-Around Services Period (as defined in the Transition Services Agreement) (the “Term”).

10.2 Termination for Cause. Licensor may terminate this License Agreement immediately on written notice to Licensee if:

(a) Licensee breaches this License Agreement and (if such breach is curable) fails to cure such breach within five (5) business days of being notified in writing to do so;

(b) Licensee (i) becomes insolvent or admits its inability to pay its debts generally as they become due; (ii) becomes subject, voluntarily or involuntarily, to any proceeding under any domestic or foreign bankruptcy or insolvency law, which is not fully stayed within seven business days or is not dismissed or vacated within 30 days after filing; (iii) is dissolved or liquidated or takes any corporate action for such purpose; (iv) makes a general assignment for the benefit of creditors; or (v) has a receiver, trustee, custodian, or similar agent appointed by order of any court of competent jurisdiction to take charge of or sell any material portion of its property or business; or

(d) there is a change in control of Licensee.

11. Post-Termination Rights and Obligations.

11.1 Effect of Termination. On the expiration or termination of this License Agreement for any reason and subject to any express provisions set out elsewhere in this License Agreement:

(a) all rights and licenses granted pursuant to this License Agreement cease;

(b) Licensee shall cease all use of the Licensed Marks except as permitted by Sections 3.3, 3.4, and 3.5; and

(c) Licensee shall promptly return to Licensor or, at Licensor's option, destroy, at Licensee's expense, all records and copies of technical and promotional material in its possession relating to the Services, and of any Confidential Information of Licensor and all copies thereof.

11.2 Surviving Rights. The rights and obligations of the parties set forth in this Section 11.2 and Section 1, Section 3.3, Section 3.4, Section 3.5, 4.1, Section 4.2, Section 7, Section 8, Section 9, Section 10, Section 11, Section 12, and Section 13, and any right, obligation, or required performance of the parties in this License Agreement that, by its express terms or nature and context, is intended to survive termination or expiration of this License Agreement, will survive any such termination or expiration.

12. Assignment. Licensee shall not assign or otherwise transfer any of its rights, or delegate or otherwise transfer any of its obligations or performance, under this License Agreement, in each case whether voluntarily, involuntarily, by operation of law, or otherwise, without Licensor's prior written consent. For purposes of the preceding sentence, and without limiting its generality, any merger, consolidation, or reorganization involving Licensee (regardless of whether Licensee is a surviving or disappearing entity) will be deemed to be a transfer of rights, obligations, or performance under this License Agreement for which Licensor's prior written consent is required. Notwithstanding the foregoing, Licensee may freely assign this License Agreement to its Affiliate. No delegation or other transfer will relieve Licensee of any of its obligations or performance under this License Agreement. Any purported assignment, delegation, or transfer in violation of this Section 12 is void. Licensors may freely assign or otherwise transfer all or any of their rights, or delegate or otherwise transfer all or any of their obligations or performance, under this License Agreement without Licensee's consent.

13. Miscellaneous.

13.1 Further Assurances. Each party shall, upon the request of the other party, promptly execute such documents and perform such acts as may be necessary to give full effect to the terms of this License Agreement.

13.2 Independent Contractors. The relationship between the parties is that of independent contractors. Nothing contained in this License Agreement will be construed as creating any agency, partnership, joint venture, or other form of joint enterprise, employment, or fiduciary relationship between the parties, and neither party has authority to contract for or bind the other party in any manner whatsoever.

13.3 Notices.

Any notice or other communication pursuant to this License Agreement must be in writing and will be deemed effectively given to the other Party on the earliest of the following: (a) three Business Days after such notice or other communication is sent by registered U.S. mail, return receipt requested; (b) one Business Day after delivery of such notice or other communication into the custody and control of a nationally or internationally recognized overnight courier service for next day delivery; and (c) the date of delivery if such notice or other communication is sent by e-mail during normal business hours of the recipient (and otherwise, the next Business Day); and (d) the date of delivery if such notice or other communication is delivered in person; or (e) the date such notice or other communication is received; in each case to the appropriate address below (or to such other address as a Party may designate by notice to the other Parties in accordance with this Section 13.3):

If to GHI or Exact:

Genomic Health, Inc.

c/o Exact Sciences Corporation

5505 Endeavour Lane

Madison, WI 53719

Attn: General Counsel

Email: [***]

With a Copy to:

Alexis Crawford Douglas

K&L Gates LLP

70 W. Madison St, Suite 3300

Chicago, IL 60602

Email: [***]

If to MDx:

MDxHealth Inc.

15279 Alton Parkway, Suite 100

Irvine, CA 92618

Attention: General Counsel

Email: [***]

With a Copy to:

Jeffrey Quillen, Esq.

Foley Hoag LLP

155 Seaport Blvd.

Boston, MA 02210

[***]

13.4 Interpretation. For purposes of this License Agreement, (a) the words “include,” “includes,” and “including” will be deemed to be followed by the words “without limitation”; (b) the word “or” is not exclusive; and (c) the words “herein,” “hereof,” “hereby,” “hereto,” and “hereunder” refer to this License Agreement as a whole. Unless the context otherwise requires, references herein: (x) to Sections, Schedules, and Exhibits refer to the Sections of, and Schedules and Exhibits attached to, this License Agreement; (y) to an agreement, instrument, or other document means such agreement, instrument, or other document as amended, supplemented, and modified from time to time to the extent permitted by the provisions thereof; and (z) to a statute means such statute as amended from time to time and includes any successor legislation thereto and any regulations promulgated thereunder. This License Agreement will be construed without regard to any presumption or rule requiring construction or interpretation against the party drafting an instrument or causing any instrument to be drafted. Any Schedules and Exhibits referred to herein will be construed with, and as an integral part of, this License Agreement to the same extent as if they were set forth verbatim herein.

13.5 Headings. The headings in this License Agreement are for reference only and do not affect the interpretation of this License Agreement.

13.6 Entire Agreement. This License Agreement, together with all Schedules and Exhibits hereto constitutes the entire agreement of the Parties to this License Agreement with respect to the subject matter contained herein, and supersedes all prior and contemporaneous understandings and agreements (whether written or oral and whether express or implied) among any Parties with respect to the subject matter hereof. In the event and to the extent that there is a conflict between the provisions of this Agreement and the provisions of any attachment hereto, the provisions of this Agreement will control. Except as specifically set forth herein, in the event and to the extent that there is a conflict between the provisions of this Agreement and the provisions of the Purchase Agreement, the Laboratory Services Agreement, or the Transition Services Agreement as it relates to the Licensed Marks, the provisions of this License Agreement will control.

13.7 No Third-Party Beneficiaries. Except as expressly set for in Section 9 with respect to Indemnified Parties, this License Agreement is for the sole benefit of the parties hereto and their respective Affiliates, successors and assigns and nothing herein, express or implied, is intended to or will confer upon any other Person any legal or equitable right, benefit, or remedy of any nature whatsoever, under or by reason of this License Agreement.

13.8 Binding Agreement. Except as expressly set forth in this License Agreement, this License Agreement is binding upon and inures to the benefit of the Parties and their respective permitted successors and assigns.

13.9 Amendment and Modification; Waiver. No amendment, supplement or other modification of any provision of this License Agreement will be valid unless it is in writing and signed by all of the Parties. No waiver of any provision of this License Agreement will be valid unless the waiver is in writing and signed by the waiving Party. The failure of any Party at any time to require performance of any provision of this License Agreement will not affect such Party’s rights at a later time to enforce such provision. No waiver by any Party of any breach of this License Agreement will be deemed to extend to any other breach hereunder or affect in any way any rights arising by virtue of any other breach.

13.10 Severability. Any provision of this License Agreement that is determined by any court of competent jurisdiction to be invalid or unenforceable will not affect the validity or enforceability of any other provision hereof or the invalid or unenforceable provision in any other situation or in any other jurisdiction. Any provision of this License Agreement held invalid or unenforceable only in part or degree will remain in full force and effect to the extent not held invalid or unenforceable.

13.11 Governing Law; Submission to Jurisdiction. This Agreement will be governed by the Laws of the State of Delaware without giving effect to any choice or conflict of law principles of any jurisdiction.

13.12 Equitable Relief. Licensee acknowledges that a breach by Licensee of this License Agreement may cause Licensor irreparable harm, for which an award of damages would not be adequate compensation and agrees that, in the event of such a breach or threatened breach, Licensor will be entitled to equitable relief, including in the form of a restraining order, orders for preliminary or permanent injunction, specific performance, and any other relief that may be available from any court, and Licensee hereby waives any requirement for the securing or posting of any bond or the showing of actual monetary damages in connection with such relief. These remedies will not be deemed to be exclusive but are be in addition to all other remedies available under this License Agreement at Law or in equity, subject to any express exclusions or limitations in this License Agreement to the contrary.

13.13 Counterparts. This Agreement may be executed by the Parties in one or more counterparts, each of which will be deemed an original but all of which together will constitute one and the same agreement. A signed copy of this Agreement delivered by facsimile, e-mail or other means of electronic transmission will be deemed to have the same legal effect as delivery of an original signed copy of this Agreement.

[Signature Page Follows]

IN WITNESS WHEREOF, the Parties have caused this License Agreement to be executed as of the Effective Date by their respective officers thereunto duly authorized.

LICENSORS	LICENSEE
GENOMIC HEALTH, INC.	MDxHEALTH S.A.
By:	By:
Name:	Name:
Title:	Title:
EXACT SCIENCES CORPORATION
By:
Name:
Title:

SCHEDULE 1

[***]

EXHIBIT A

Brand Manual/Use Guidelines

Exhibit F

Form of Transition Services Agreement

Execution Version

TRANSITION SERVICES AGREEMENT

This Transition Services Agreement (together with the Annexes attached hereto and incorporated herein, this “Agreement”), is entered into as of August 2, 2022 (the “Effective Date”), by and between MDxHealth, SA, a limited liability company (société anonyme) organized and existing under the laws of Belgium (together with, MDxHealth Inc., a wholly owned subsidiary, collectively, “MDx”), Genomic Health, Inc., a Delaware corporation (“GHI”), and Exact Sciences Corporation, a Delaware corporation (“Exact” and together with GHI, the “Service Providers”). MDx, GHI and Exact are sometimes hereinafter referred to individually as a “Party” or collectively as the “Parties.” Capitalized terms used but not defined herein will have the meanings ascribed to such terms in the Purchase Agreement.

STATEMENT OF PURPOSE

WHEREAS, GHI is engaged, through its urology diagnostics division, in the business associated with the development, marketing and performance of the Oncotype DX Genomic Prostate Score test (the “Acquired Test”).

WHEREAS, MDxHealth, SA and GHI are parties to that certain Asset Purchase Agreement of even date herewith (the “Purchase Agreement”), concerning, among other things, the sale of certain assets of the business of GHI related to the Acquired Test, and MDxHealth, Inc. and GHI are parties to that certain Reference Laboratory Services Agreement of even date herewith (the “Reference Lab Agreement”), concerning, among other things, the provision by GHI of certain reference lab services on behalf of MDx’s customers; and

WHEREAS, the Purchase Agreement provides that, in connection with and as a condition to the consummation of the transactions contemplated thereby, the Parties will enter into this Agreement, which constitutes the Transition Services Agreement referred to in the Purchase Agreement, pursuant to which Service Providers will, or will cause their Affiliates to, provide MDx with certain services on a transitional basis following Closing,

NOW, THEREFORE, in consideration of the foregoing and the mutual agreements and covenants set forth herein, the Parties agree as follows:

ARTICLE I

PROVISION OF SERVICES

1.1 Provision of Services. Subject to the terms and conditions of this Agreement, following Closing, Service Providers shall provide, and take commercially reasonable efforts to cause their Affiliates to provide, the services set forth on Annex A (the “Services”) for the applicable Term (as defined in ARTICLE III) solely to MDx and solely for the purposes of supporting the operation of the Business for a limited period of time after Closing in substantially the same manner as the Business was conducted prior to Closing. Annex A provides, with respect to each Service and, to the extent applicable, the service type, a tracking or index number, a description of the applicable Service, the End Date (as defined in ARTICLE III) for each Service, and compensation rates (including terms and frequency of payment). To the extent a Service Provider’s responsibility in any of the Services relies upon input, instructions or policies from MDx, until MDx provides such input, instructions or policies, Service Providers will be excused from such responsibility until such input, instructions or policies are provided by MDx. MDx acknowledges that the Services are administrative in nature and do not constitute nor shall they be construed as constituting professional advice, including regulatory, legal, investment, audit, accounting or tax advice, nor the provision of such legal, regulatory, investment, audit, accounting or tax services for or on behalf of MDx or any other Person.

1.2 Additional Services. During the Term, MDx may request in writing of the Service Providers any additional services (“Additional Service”) not listed on Annex A that, pursuant to the reasonable discussions and negotiations among the Parties, are reasonably necessary for the Service Providers (and no other Person) to provide for the development or operation of the Business after Closing. Service Providers (and no other Person) shall take any such request by MDx into reasonable consideration and, within a reasonable time after Service Providers receive such written request, enter into good-faith negotiations to determine the terms and conditions pursuant to which the Additional Service would be provided, and if so agreed, the Parties will amend Annex A pursuant to Section 7.11 to set forth such agreed-upon terms and conditions. Any such Additional Service so provided by the Service Providers (or their Affiliates) will constitute Services under this Agreement and be subject in all respect to the provisions of this Agreement as if fully set forth on Annex A as of the Effective Date.

1.3 Standards of Service. The Service Providers will provide the Services in a proper and professional manner, in conformance with all applicable Laws, and at the same service levels, within the same timeframes and with the same level of care and skill as applied to the operation of the Business by the Service Providers (or their Affiliates) prior to Closing. Service Providers agree to assign reasonably sufficient resources and qualified personnel to perform the Services and to use commercially reasonable efforts to maintain continuity and availability of key personnel assigned by Service Providers to support MDx, in accordance with the standards set forth in the preceding sentence. For the avoidance of doubt, the standard at which such Services are provided is not and will not be deemed to be a guaranty of any particular result.

1.4 Responsibility for TSA Personnel. All personnel employed, engaged or otherwise furnished by the Service Providers (or their Affiliates) in connection with their rendering of the Services will be the Service Providers’ (or their Affiliates’) employees, agents or contractors, as the case may be (collectively, the “TSA Personnel”). Service Providers (or their Affiliates) will: (a) have sole and exclusive responsibility for the TSA Personnel; (b) supervise the TSA Personnel; and (c) cause the TSA Personnel to reasonably cooperate with MDx in performing the Services in accordance with the terms of this Agreement. The TSA Personnel will be under the direction, control and supervision of the Service Providers (or their Affiliates) (and not of MDx or any of its Affiliates), and the Service Providers (or their Affiliates) will have the sole right to exercise all authority with respect to the TSA Personnel, and in no event will the TSA Personnel be deemed to be employees or agents of MDx. The Service Providers (or their Affiliates) will be solely responsible for the compensation and payment of the TSA Personnel, and for all applicable wages, bonuses, commissions, employee benefits, withholding, employment or payroll taxes, unemployment insurance, unemployment compensation, severance, workers’ compensation, disability, government pension schemes, retirement contributions, and any other insurance and fringe benefits with respect to the TSA Personnel. The TSA Personnel will not be entitled to participate in or receive any benefit or right as an employee or participant under MDx’s employee benefit and welfare plans, including employee insurance, pension, savings and security plans as a result of or in connection with the provision of Services to MDx. The Service Providers (or their Affiliates) will have the exclusive right to hire and fire any such personnel in accordance with applicable Law. MDx will not have any right to direct and control any of the TSA Personnel under this Agreement.

1.5 Third-Party Providers. Without limiting the generality of Sections 1.1 and 1.3, the Service Providers may engage third-party providers or subcontractors (each such retained party, a “Third-Party Provider”) to provide all or part of any Service hereunder. The Service Providers will in all cases retain responsibility for the provision to MDx of Services to be performed by any Third-Party Provider and, except as otherwise specified in Annex A, any payments to Third-Party Providers and any and all tax consequences related thereto.

1.6 Service Coordinators. During the Term, MDx, on the one hand, and the Service Providers, on the other hand, will each designate an employee with sufficient knowledge and background to act as the principal point-of-contact between MDx and the Service Providers (and their Affiliates) with respect to each of the Services to be provided to MDx hereunder (each, a “Service Coordinator”). The Service Coordinators will serve as the primary contact and coordinate the provision of the Services for which that person has been designated. The initial Service Coordinator for GHI and Exact will be [***], and the initial Service Coordinator for MDx will be [***]. Without limiting the generality of Section 1.3, each Party may change its Service Coordinator at any time upon written notice to the other Parties; provided, however, that any replacement Service Coordinator will be of a comparable level of seniority and authority within the applicable Party’s organization.

1.7 Obligation to Re-Perform Services. In the event of any breach of this Agreement by Service Providers with respect to the provision of any Services (with respect to which Service Providers can reasonably be expected to re-perform in a commercially reasonable manner), then the Service Providers (or their Affiliates) will perform or re-perform such Services upon written request from MDx as promptly as reasonably possible and at no additional cost to MDx. Except as otherwise specified in Annex A, any request for re-performance pursuant to this Section 1.7. must be in writing (including email) and specify in reasonable detail the particular error, defect or breach, and such request must be made no more than ten (10) days from the date on which such breach was discovered by MDx, provided that any delay in giving such notice shall not affect either Service Provider’s obligation to re-perform under this Section 1.7 unless, and solely to the extent that, such delay has adversely affected such Service Provider.

ARTICLE II

PAYMENT TERMS

2.1 Payment; Invoice Statements.

(a) The applicable fees and costs for the provision of the Services are as set forth across each applicable Service on Annex A.

(b) Invoice statements (“Statements”) for the Services will be rendered each month by the Service Providers to MDx setting forth the fees and costs due for Services delivered during the preceding month. All amounts set forth in a Statement shall be paid by MDx no later than 30 days after receipt of such Statement. Each Statement will set forth in reasonable detail a description of such Services and the amounts charged therefor, if any. Payments past due shall bear interest at a rate of simple interest per annum equal to [***] per annum, unless otherwise disputed in accordance herewith.

2.2 Payment Disputes. If MDx has a good faith disagreement with any charge set forth in a Statement from the Service Providers for Services performed hereunder (each such disagreement a “Payment Dispute”), then MDx will within thirty (30) days of receiving the applicable Statement giving rise to a Payment Dispute send written notice to the Service Coordinator specifying in reasonable detail the specific amounts disputed and the reason for such Payment Dispute. If MDx fails to deliver the aforementioned notice within such thirty (30) day period, then MDx shall be deemed to have accepted the amounts set forth in such Statement and waived its right to raise a Payment Dispute in respect thereof. If MDx provides timely notice of a Payment Dispute, then promptly upon Service Providers’ receipt thereof, the Service Coordinators will meet in good faith to resolve such Payment Dispute. If the Service Coordinators cannot settle any such Payment Dispute within ten (10) days after the Service Providers’ receipt of written notice thereof, such Payment Dispute will be escalated to executives of each Party with authority to resolve such Payment Dispute who will negotiate in good faith to attempt to resolve the Payment Dispute for up to ten (10) additional days. If any Payment Dispute(s) are resolved in MDx’s favor, then the Service Providers will promptly refund to MDx all overpaid amounts or, with MDx’s prior written consent, credit such amounts toward future Services provided. If any Payment Dispute(s) are resolved in the Service Providers’ favor, then MDx will promptly remit to the Service Providers all underpaid amounts. During a Payment Dispute, MDx will continue to timely pay the Service Providers all undisputed fees and costs invoiced in Statements from the Service Providers and, provided that MDx timely pays all undisputed amounts invoiced in Statements from the Service Providers, the Service Providers (or their Affiliates) will continue to perform the Services pending resolution of the Payment Dispute.

2.3 Taxes. Except as otherwise explicitly stated on Annex A, the fees set forth for each Service on Annex A do not include any sales, valued added, use or other similar gross-receipts Taxes required by Law to be collected from MDx or which may be assessed on the Services. If any such Taxes are assessed on the provision of the Services, Service Providers will include such amounts in the Statements delivered to MDx and MDx will satisfy such amounts, in both cases, in the manner set forth in Section 2.1, and Service Providers will timely remit such collected amounts to the appropriate Taxing authority, unless MDx is required by Law to remit such Taxes on its own behalf.

ARTICLE III

TERM; TERMINATION

3.1 Term; Extension of Services.

(a) The term of this Agreement (the “Term”) will commence on the Effective Date and end with respect to any individual Service or all the Services, as applicable, on the earliest to occur of (a) the mutual written agreement of the Parties, (b) the end date (the “End Date”) of the applicable Service as indicated on Annex A, and (c) the date on which the provision of such Service has been terminated or canceled in accordance with Sections 2.2, 3.2 or 3.3. For the avoidance of doubt, the termination or cancellation of this Agreement with respect to any one Service will apply only with respect to that individual Service, and not the other Services, unless specified in writing otherwise.

(b) Subject to this ARTICLE III, neither Service Provider will be obligated to perform any Service after the applicable End Date; provided, however, that (i) with regard to the Services set forth in Schedule 1 of Annex A (the “Wrap-Around Services”), if in the good faith judgment of MDx the lab testing activities set forth in the Reference Laboratory Services Agreement would be potentially materially negatively impacted if such Services were halted at the applicable End Date, then the applicable End Date shall be extended following notice delivered by MDx to GHI prior to such End Date (such period, commencing from the Effective Date of this Agreement to the latest End Date for any of the Wrap-Around Services, hereinafter referred to as the “Wrap-Around Services Period”) and (ii) with regard to the Services other than the Wrap-Around Services, if MDx desires to continue to receive any of the Services after the original End Date of such Service, the Parties may negotiate in good faith to amend the End Date of such Service in writing for such Service (each, a “Services Extension Term”), with such adjustments as the Parties may otherwise mutually agree in writing. For the avoidance of doubt, in no event shall the Wrap-Around Services continue past December 31, 2022. For each renewed Service, Service Providers reserve the right to increase the price of such Services during its Services Extension Term, at an amount not to exceed more than [***] increase above the price at which such Services were provided immediately prior to the extension of the End Date thereof (the “Cap”); provided, that the Cap will not apply if scope of such Services is materially expanded from the scope of Services provided immediately before the extension of the applicable End Date. For the avoidance of doubt, the Cap will not apply to any third-party costs or payments (as referenced in Section 1.5).

3.2 Termination of Service by MDx. MDx may terminate all or part of any Service for any or no reason prior to the applicable End Date upon written notice to the Service Providers. In the event that MDx terminates the provision of any Service pursuant to this Section 3.2, the fee for such Service as reflected on the Statement therefor will continue to reflect an amount due for such Services as though such Services were provided for the entire month in which the termination by MDx pursuant to this Section 3.2 takes effect.

3.3 Termination of Service by the Service Providers. Exact or GHI may terminate all of the Services or all or part of any Service immediately upon written notice to MDx in the event MDx breaches any provision of this Agreement in any material respect (excluding any good faith Payment Dispute), which breach remains uncured by MDx for a period of thirty (30) days following written notice from the Service Providers to MDx thereof.

3.4 Effect of Termination. Except as provided elsewhere in this ARTICLE III*,* termination of all or part of any one Service will not terminate or cause to be terminated any other Service. All rights and obligations of the Parties which by their nature or the context are intended to continue beyond expiration or termination of this Agreement will survive such termination or expiration, including without limitation Sections 2.1(b), Section 2.2, Section 2.3, this Section 3.4, Section 4.2, Section 4.3, ARTICLE V, ARTICLE VI, and ARTICLE VII, all of which will survive any termination, cancellation or expiration of this Agreement. Termination of this Agreement will not relieve any Party of any liability to the other Party for any breach or nonfulfillment of any obligation under this Agreement occurring prior to such termination.

3.5 Force Majeure. Notwithstanding anything to the contrary contained in this Agreement, neither party (nor their respective Affiliates) will be liable for any interruption, delay or failure to perform any obligation under this Agreement when such interruption, delay or failure was caused directly by an event beyond such Party’s reasonable control, including any (a) act of God; (b) flood, fire, earthquake, pandemic, epidemic or explosion; (c) war, invasion, hostilities (whether war is declared or not), terrorist threats or acts, riot or other civil unrest; (d) obligation to comply with a Governmental Order or Law; (e) embargoes or blockades; (f) national or regional emergency; (g) strikes, labor shortages, stoppages or slowdowns, or other industrial disturbances; (h) telecommunication breakdowns, power outages or shortages, lack of warehouse or storage space, inadequate transportation services, or inability or delay in obtaining sufficient supplies of adequate or suitable materials; and (i) other similar events (“Force Majeure Event”). The affected Party shall notify the other Party of such Force Majeure Event within three (3) days after such occurrence by giving written notice to the other Party stating the nature of the event, its anticipated duration and any action being taken to avoid or minimize its effect. The suspension of performance shall be of no greater scope and no longer duration than is necessary and the affected Party will use commercially reasonable efforts to remedy the situation and remove the cause and effect of the Force Majeure Event.

ARTICLE IV

ACCESS; SERVICE RECORDS; AUDITS

4.1 Consents. The Service Providers will use commercially reasonable efforts to obtain any required approval, consent or waiver of any third party that is necessary for the Service Providers’ provision of the Services otherwise to be provided pursuant to the terms of this Agreement, in each case, in accordance with the terms and conditions of any applicable agreements between such third party and Exact or GHI, as applicable. Service Providers will not be obligated to obtain any consent or approval to the extent obtaining the same would violate, conflict with, or cause the Service Providers to lose any benefit otherwise received by the Service Providers under such agreement as respects their business and operations (other than the Business). Service Providers will not be obligated to provide any Service that requires a third-party consent that has not been obtained. If Service Providers are unable to provide a Service due to the failure or inability to obtain a necessary consent or approval as provided in this Section 4.1, then the Parties will cooperate and negotiate in good faith to determine a reasonable alternative approach, and Annex A will be amended by the Parties to reflect any applicable changes to the terms therein. For the avoidance of doubt, Service Providers will not be deemed to be in breach of this Agreement if, despite their commercially reasonable efforts, such approval, consent, or waiver is not obtained.

4.2 Service Records. For the duration of the Term and thereafter in accordance with Exact’s or GHI’s, as applicable, record retention policies and applicable Law, but in no event for a period of less than three (3) years, the Service Providers will maintain books and records related to the Services provided hereunder and reasonable supporting documentation of charges and expenses incurred in providing such Services (the “Service Records”). Exact or GHI, as applicable, will make the Service Records available to MDx (and its Representatives) for its review and copy, upon reasonable advance written notice, at MDx’s expense, during normal business hours and on dates mutually agreed upon in writing by the applicable Parties. For the purposes of this Agreement, “Representative” means, with respect to a particular Person, any director, manager, officer, employee, agent, consultant, advisor or other representative of such Person, including legal counsel, accountants and financial advisors.

4.3 Audits. MDx will have the right no more than one (1) time during the Term and one (1) time during the twelve-month period following the end of the Term, at its sole cost and expense and upon at least thirty (30) days’ advance written notice, to have the applicable and relevant Service Records reviewed by MDx and/or audited by an independent certified public accountant, selected by MDx and reasonably agreeable to the Service Providers, under appropriate confidentiality provisions, for the purpose of verifying the accuracy of the fees and costs calculations set forth in Statements for Services provided under this Agreement. No review or audit will be conducted outside of normal business hours or in a manner that interferes unreasonably with the Service Providers’ business or operations. Nothing herein will require the Service Providers to provide MDx or its Representatives access to or copies of any Service Records that must be maintained as confidential by applicable Law or in accordance with the terms of a written agreement with a third party. MDx will be required to reimburse the Service Providers for all reasonable out-of-pocket third-party costs and expenses reasonably incurred by the Service Providers in connection with any such audits.

ARTICLE V

RESTRICTIVE COVENANTS

5.1 Confidentiality.

(a) Confidential Information. From time to time during the Term, the Parties or their Affiliates may disclose or make available (as the “DisclosingParty”) to another Party or its Affiliates (as the “Receiving Party”) information about the Disclosing Party’s (or the Disclosing Party’s Affiliates’) business or affairs, including information relating to the Business, clinical information, customers, clients, suppliers, vendors, investors, lenders, consultants, independent contractors or employees, price lists and pricing policies, financial statements and information, budgets and projections, business plans, production costs, market research, marketing, sales and distribution strategies, manufacturing techniques, processes and business methods, technical information, pending projects and proposals, new business plans and initiatives, research and development projects, inventions, discoveries, ideas, technologies, trade secrets, know-how, formulae, designs, patterns, marks, names, improvements, industrial designs, mask works, works of authorship and other Intellectual Property, devices, samples, plans, drawings and specifications, photographs and digital images, computer software and programming, the terms of this Agreement, all other confidential information and materials relating to its business or affairs, and all notes, analyses, compilations, studies, summaries, reports, manuals, documents and other materials that ought reasonably to be considered confidential prepared by or for the Disclosing Party (or its Affiliates) containing or based in whole or in part on any of the foregoing, whether in verbal, written, graphic, electronic or any other form, whether or not conceived, developed or prepared in whole or in part by the Disclosing Party and whether or not marked as confidential (collectively, “Confidential Information”). For clarity, the Parties acknowledge and agree that the Business Intellectual Property Assets shall be the Confidential Information of MDx.

(b) Exclusions. Confidential Information does not include information that, the Receiving Party can demonstrate with competent written records: (i) was publicly known to it at the time of disclosure, or has become publicly known through no breach of this Agreement or the Ancillary Documents by Receiving Party or its Representatives; (ii) rightfully obtained by the Receiving Party on a non-confidential basis from a third party that was in lawful possession of such information and not under any obligations of confidentiality regarding such information; or (iii) independently developed by the Receiving Party without reference to or use of any the Disclosing Party’s Confidential Information and that can be demonstrated by the Receiving Party through contemporaneous written records.

(c) Protection of Confidential Information. The Receiving Party will safeguard the Confidential Information from unauthorized use, access, or disclosure using at least the degree of care it uses to protect its own confidential information and in no event less than a reasonable degree of care. The Receiving Party may use Confidential Information only for the purposes of fulfilling its obligations under this Agreement and enforcing its rights under this Agreement. The Receiving Party will not disclose the Disclosing Party’s Confidential Information to any person or entity, except: (a) to the Receiving Party’s employees, Affiliates and subcontractors who have a need to know the Confidential Information for the sole purpose of fulfilling Receiving Party’s obligations under this Agreement and who have been advised of the terms of this Section 5.1 and are bound by written obligations of confidentiality no less restrictive than the obligations of confidentiality herein, (b) as provided for in the Purchase Agreement or Ancillary Documents, or (c) to the limited extent required in order to comply with the order of a court or other Governmental Authority, or as otherwise necessary to comply with applicable Law, provided that the Receiving Party will promptly provide the Disclosing Party with prior written notice so that the Disclosing Party may seek a protective order, provide reasonable assistance to the Disclosing Party in seeking such an order and will limit disclosure of such Confidential Information to only that portion of the Confidential Information which is required to be disclosed; provided that any Confidential Information so disclosed shall maintain its confidentiality protection for all purposes other than such legally compelled disclosure. Receiving Party will be liable for any breach of these confidentiality provisions by its Representatives.

(d) Return or Destruction of Confidential Information. On the expiration or termination of this Agreement or at the Disclosing Party’s written request, the Receiving Party will promptly return to the Disclosing Party all copies, whether in written, electronic, or other form or media, of the Disclosing Party’s Confidential Information, or at Disclosing Party’s written direction destroy all such copies and certify in writing to the Disclosing Party that such Confidential Information has been destroyed. Notwithstanding the foregoing, the Receiving Party may retain a copy of the Disclosing Party’s Confidential Information (a) to the extent and for so long as required by applicable Law, and (b) held electronically in archive or backup systems in accordance with general systems archiving and backup policies; on the condition that, in each instance, all such retained Confidential Information remains subject to the provisions of this Section 5.1.

(e) Survival. The obligations imposed by this Section 5.1 will survive the termination or expiration of this Agreement for five (5) years from the date of such termination or expiration, except with respect to Confidential Information that constitutes (i) trade secrets, which will survive the termination or expiration of this Agreement for so long as the trade secret information is treated as trade secret under applicable Law and (ii) Business Intellectual Property Assets, which will survive the termination or expiration of this Agreement.

5.2 Non-Solicitation. MDx will not, and will cause its Affiliates not to, during the Term and for a period of two (2) years thereafter (the “RestrictedPeriod”), directly or indirectly hire or solicit any Person that is or was employed or served as an independent contractor of the Service Providers or their Affiliates as of the Effective Date or during the Restricted Period and (i) was providing Services to MDx pursuant to the terms of this Agreement or (ii) became known to MDx in connection with the transactions contemplated by the Purchase Agreement, or in connection with the Services or performance by the Parties of this Agreement (“Restricted Persons”); providedthat the foregoing will not restrict MDx from hiring the employees or independent contractors of the Service Providers who provide services exclusively to the Business, in connection with transactions contemplated by the Purchase Agreement, including Transfer Employees. Notwithstanding the foregoing, nothing in this Section 5.2 will restrict MDx from (a) making any general solicitation for employment that is not directed at the Restricted Persons or hiring any such Restricted Persons who respond to such general solicitations, (b) using the services of personnel recruiting firms provided that MDx does not direct such firms to target the Exact, GHI, their Affiliates, or the Restricted Persons or hiring any such Restricted Persons who respond to such recruiting firm’s solicitations, or (c) soliciting or hiring any Restricted Person who has not been employed by Exact, GHI, or their Affiliates for six months immediately prior to the solicitation or hiring.

5.3 Specific Performance. The Parties agree and acknowledge that money damages may not be an adequate remedy for any breach of the provisions of this ARTICLE V (and thus waive any defense that there is an adequate remedy at law), and that any Party may in its sole discretion apply to any court of law or equity of competent jurisdiction for specific performance or injunctive relief (without posting a bond or other security) in order to enforce or prevent any violation or threatened violation of the provisions of this ARTICLE V.

5.4 No Primacy. Nothing contained in this ARTICLE V will be deemed to modify or change the terms and conditions of the Purchase Agreement.

ARTICLE VI

INDEMNIFICATION; REMEDIES; WARRANTY DISCLAIMER

6.1 Indemnification. Each Party (the “Indemnifying Party”) will indemnify, defend and hold harmless the other Parties and its Affiliates, and their respective Representatives and its employees and agents (collectively, the “Indemnitees”) from, and pay and reimburse the Indemnitees for, any loss, liability, damage, cost (including court costs, costs of investigation, and reasonable legal fees and expenses), expense, judgment, or tax (“Loss”) that such Indemnitee may incur may suffer, sustain or become subject to as a result of, in connection with or by virtue of any claim to the extent such claim is based upon (a) any material breach or violation by the Indemnifying Party of any covenant or obligation under this Agreement; or (b) fraud, willful misconduct, intentional acts or gross negligence committed by the Indemnifying Party or any of its employees or agents and, in each case, which events, acts or omissions occur in connection with the Services provided or obtained under this Agreement, except in any case to the extent such Loss is caused by any of the Indemnitees’ negligence, willful misconduct or breach of this Agreement.

6.2 Exclusive Remedies; Limitations; Survival. MDx shall be entitled to any remedy available at law or in equity for any breach of Section 4.2 or Section 5.1. EXCEPT AS SET FORTH IN SECTIONS 1.7, 2.2 AND 5.3, THE REMEDIES DESCRIBED IN THIS ARTICLE VI ARE THE SOLE AND EXCLUSIVE REMEDIES OF THE PARTIES WITH RESPECT TO THE MATTERS SET FORTH IN SECTION 6.1. IN NO EVENT WILL EITHER PARTY BE LIABLE TO THE OTHER PARTY UNDER OR IN CONNECTION WITH THIS AGREEMENT FOR ANY REMOTE, INDIRECT, SPECULATIVE, CONSEQUENTIAL, SPECIAL, INCIDENTAL, EXEMPLARY OR PUNITIVE LOSS OR DAMAGES (INCLUDING LOST PROFITS OR SALES) ARISING FROM OR RELATED TO THE SERVICES, EVEN IF ADVISED OF THEIR POSSIBLE EXISTENCE. THE ALLOCATIONS OF LIABILITY IN THIS SECTION REPRESENT THE AGREED AND BARGAINED-FOR UNDERSTANDING OF THE PARTIES WITH RESPECT TO THE ALLOCATION OF RISKS ARISING HEREUNDER. NOTWITHSTANDING ANYTHING HEREIN TO THE CONTRARY, IN NO EVENT WILL ANY PARTY’S LIABILITY HEREUNDER EXCEED TWO TIMES THE AMOUNTS ACTUALLY PAID BY MDX TO SERVICE PROVIDERS UNDER THIS AGREEMENT. THE OBLIGATIONS OF THE PARTIES THE OBLIGATIONS OF THE PARTIES PURSUANT TO THIS ARTICLE VI WILL SURVIVE THE END OF ANY END DATE AND EXPIRATION OR OTHER TERMINATION OF THIS AGREEMENT FOR A PERIOD OF ONE YEAR.

6.3 Warranty Disclaimer. ALL SERVICES ARE PROVIDED UNDER THIS AGREEMENT “AS IS” AND “WITH NO FAULTS.” SERVICE PROVIDERS DO NOT MAKE ANY WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, WITH RESPECT TO ANY SERVICES PERFORMED HEREUNDER. SERVICE PROVIDERS HEREBY EXPRESSLY DISCLAIM ALL WARRANTIES FOR MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE WITH RESPECT TO THIS AGREEMENT, THE SERVICES AND ANY RESULTS THEREOF.

ARTICLE VII

MISCELLANEOUS

7.1 Software Ownership. MDx acknowledges and agrees that: (a) nothing in this Agreement (including the provision of Services hereunder) will be construed as transferring any ownership interest in any software of any third parties or any licenses thereto made available to MDx by either Service Provider in connection with the provision of the Services (“Third Party Software”), or any proprietary software of Service Providers or their Affiliates used in connection with the provision of the Services (“Service Provider Proprietary Software”); (b) it will not obtain or claim any right, title or ownership interest in any Third Party Software or Service Provider Proprietary Software, or any portion thereof or any intellectual property rights therein; and (c) Service Providers and their Affiliates (or the third party owners, as applicable) will retain all right, title and interest, including all intellectual property rights, in and to all portions of the Third Party Software and Service Provider Proprietary Software, and any modifications, derivative works, and copies thereof. MDx may not recompile, decompile, disassemble, reverse engineer, or make or distribute any other form of, or any derivative work from, any Third Party Software or Service Provider Proprietary Software. Upon termination of this Agreement or termination of any Service as provided under this Agreement, MDx will immediately cease using and promptly deliver to Service Providers all Third Party Software, all Service Provider Proprietary Software, and any executable copies of any of the foregoing in the possession or control of MDx or any of its Affiliates.

7.2 No Third-Party Beneficiaries. Except as expressly set forth in this Agreement, this Agreement does not confer any rights or remedies upon any person or entity other than the Parties and their respective successors and permitted assigns.

7.3 Purchase Agreement; No Set-off. Neither the making nor the acceptance of this Agreement will enlarge, restrict or otherwise modify the terms of the Purchase Agreement or constitute a waiver or release by any Party of any liabilities, obligations or commitments imposed upon them by the terms of the Purchase Agreement, including the representations, warranties, covenants, agreements and other provisions of the Purchase Agreement. Each Party, on behalf of itself and each of its Affiliates, agrees that (a) its rights and remedies under this Agreement will not give rise to any right of set-off, defense or counterclaim under the Purchase Agreement or any Ancillary Document (other than this Agreement) and (b) any rights and remedies that it or any of its Affiliates may have under the Purchase Agreement or any Ancillary Document (other than this Agreement) will not give rise to any right it may have to set-off, defense or counterclaim under this Agreement.

7.4 Entire Agreement. This Agreement (together with the Annexes and Attachments attached hereto), the Purchase Agreement and the Ancillary Documents (collectively, the “Transaction Agreements”), together, constitute the entire agreement among the Parties with respect to the subject matter of the Transaction Agreements and supersede all prior and contemporaneous agreements (whether written or oral and whether express or implied) among any Parties with respect to the subject matter of the Transaction Agreements. In the event and to the extent that there is a conflict between the provisions of this Agreement and the provisions of any Annex or Attachment hereto, the provisions of this Agreement will control. Except as specifically set forth herein, in the event and to the extent that there is a conflict between the provisions of this Agreement and the provisions of the Purchase Agreement, the provisions of the Purchase Agreement will control. Except as specifically set forth herein, in the event and to the extent that there is a conflict between the provisions of the Reference Laboratory Services Agreement and this Agreement as it relates to the provision of the services under the Reference Laboratory Services Agreement, the provisions of the Reference Laboratory Services Agreement will control; provided, however, that a breach by MDx of its obligations under Section 3.8 of the Reference Laboratory Services Agreement shall not, in itself, be deemed to limit, reduce or otherwise relieve any of the Service Providers’ obligations under this Agreement.

7.5 Protected Health Information. To the extent MDx is a “covered entity”, as defined under HIPAA or either Service Provider functions as a “business associate”, as defined under HIPAA, in providing the Services hereunder, the Parties agree to abide by the business associate agreement attached hereto as Attachment 1, which is incorporated herein by reference.

7.6 Successors and Assigns; Assignment. This Agreement will be binding upon and inure to the benefit of the Parties and their respective successors and permitted assigns. No Party may assign, delegate or otherwise transfer (whether by operation of Law, merger, consolidation, amalgamation, sale of assets or equity or otherwise and whether directly or indirectly) this Agreement or any of its rights, interests or obligations in this Agreement, in each case, without the prior written approval of the other Parties, which will not be unreasonably withheld, conditioned or delayed.

7.7 Counterparts. This Agreement may be executed by the Parties in one or more counterparts, each of which will be deemed an original but all of which together will constitute one and the same agreement. A signed copy of this Agreement delivered by facsimile, e-mail or other means of electronic transmission will be deemed to have the same legal effect as delivery of an original signed copy of this Agreement.

7.8 Notices. Any notice or other communication pursuant to this Agreement must be in writing and will be deemed effectively given to another Party on the earliest of the following: (a) three Business Days after such notice or other communication is sent by registered U.S. mail, return receipt requested; (b) one Business Day after delivery of such notice or other communication into the custody and control of a nationally or internationally recognized overnight courier service for next day delivery; and (c) the date of delivery if such notice or other communication is sent by e-mail during normal business hours of the recipient (and otherwise, the next Business Day); and (d) the date of delivery if such notice or other communication is delivered in person; or (e) the date such notice or other communication is received; in each case to the appropriate address below (or to such other address as a Party may designate by notice to the other Parties in accordance with this Section 7.8):

If to Exact or GHI:	If to MDx:
c/o Exact Sciences Corporation	MDxHealth, Inc.
5505 Endeavor Lane	15279 Alton Parkway, Suite 100
Madison, WI 53719	Irvine, CA 92618
Attention: [***], Deputy General	Attention: General Counsel
Counsel	Email: [***]
Email: [***]
with a simultaneous copy (which will not constitute notice) to:	with a simultaneous copy (which will not constitute notice) to:
K&L Gates LLP	Foley Hoag LLP
300 South Tryon Street, Suite 1000	155 Seaport Boulevard
Charlotte, NC 28202	Boston, MA 02210
Attention: John Blair	Attention: Jeffrey L. Quillen
Email: [***]	Email: [***]

7.9 Jurisdiction; Service of Process. ANY PROCEEDING ARISING OUT OF OR RELATING TO THIS AGREEMENT WILL BE BROUGHT AND DETERMINED EXCLUSIVELY IN THE DELAWARE COURT OF CHANCERY OF THE STATE OF DELAWARE; PROVIDED, THAT, IF THE DELAWARE COURT OF CHANCERY DOES NOT HAVE JURISDICTION, ANY SUCH PROCEEDING WILL BE BROUGHT EXCLUSIVELY IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE OR THE SUPERIOR COURT OF THE STATE OF DELAWARE (COMPLEX COMMERCIAL LITIGATION DIVISION) STATE. EACH PARTY (A) CONSENTS TO THE PERSONAL JURISDICTION OF SUCH COURTS (AND OF THE APPROPRIATE APPELLATE COURTS THEREFROM) IN ANY PROCEEDING ARISING OUT OF OR RELATING TO THIS AGREEMENT, (B) WAIVES ANY VENUE OR INCONVENIENT FORUM DEFENSE TO ANY PROCEEDING MAINTAINED IN SUCH COURTS, (C) EXPRESSLY WAIVES ALL RIGHT TO TRIAL BY JURY IN ANY ACTION OR PROCEEDING ARISING OUT OF OR RELATING TO THIS AGREEMENT, AND (D) EXCEPT AS OTHERWISE PROVIDED IN THIS AGREEMENT, PROCESS IN ANY SUCH PROCEEDING MAY BE SERVED ON ANY PARTY ANYWHERE IN THE WORLD.

7.10 Governing Law. This Agreement will be governed by the Laws of the State of Delaware without giving effect to any choice or conflict of law principles of any jurisdiction.

7.11 Amendments; No Waivers. No amendment, supplement or other modification of any provision of this Agreement will be valid unless it is in writing and signed by all of the Parties. No waiver of any provision of this Agreement will be valid unless the waiver is in writing and signed by the waiving Party. The failure of any Party at any time to require performance of any provision of this Agreement will not affect such Party’s rights at a later time to enforce such provision. No waiver by any Party of any breach of this Agreement will be deemed to extend to any other breach hereunder or affect in any way any rights arising by virtue of any other breach.

7.12 Severability. Any provision of this Agreement that is determined by any court of competent jurisdiction to be invalid or unenforceable will not affect the validity or enforceability of any other provision hereof or the invalid or unenforceable provision in any other situation or in any other jurisdiction. Any provision of this Agreement held invalid or unenforceable only in part or degree will remain in full force and effect to the extent not held invalid or unenforceable.

7.13 Construction. The article and section headings in this Agreement are inserted for convenience only and are not intended to affect the interpretation of this Agreement. Unless the context requires otherwise, references herein (a) to any Article, Section or Annex means such Articles or Section of, or such Annex, attached to this Agreement, (b) to any Law means such Law as amended from time to time and including any successor provisions thereto and all rules and regulations promulgated thereunder and (c) to any agreement, instrument or other document means such agreement, instrument or other document as amended, restated, supplemented or otherwise modified from time to time in accordance therewith and, as applicable, herewith. For purposes of this Agreement, (i) the words “include”, “including” and “including” will be deemed to be followed by the words “without limitation,” (ii) the word “or” is disjunctive but not necessarily exclusive and (d) the words “herein,” “hereof,” “hereby,” “hereto,” and “hereunder” refer to this Agreement as a whole. This Agreement will be construed as if drafted jointly by the Parties and no presumption or burden of proof will arise favoring or disfavoring any Party by virtue of the authorship of any provision in this Agreement. All accounting terms not specifically defined in this Agreement will be construed in accordance with GAAP. All words in this Agreement will be construed to be of such gender or number as the circumstances require. References in this Agreement to time periods in terms of a certain number of days mean calendar days unless expressly stated herein to be Business Days. If any time period for giving notice or taking action hereunder expires on a day which is not a Business Day, the time period will automatically be extended to the Business Day immediately following such day.

7.14 No Partnership or Joint Venture; Independent Contractor. In providing the Services, Service Providers and their Affiliates will act solely as an independent contractor and not as an agent of MDx, and Service Providers and their Affiliates will retain and exercise the authority to control, oversee and direct the performance of the details and the means and manner of the Services. MDx will have the right (to the extent consistent with sound operating practices in the discretion of Service Providers) to direct Service Providers and their Affiliates to conduct or not to conduct certain Services (consistent with Service Providers’ obligations and the terms and conditions contained herein), but the means and manner of the same will be in the exclusive control of Service Providers and their Affiliates. This Agreement is not intended to and will not be construed as creating a joint venture, partnership, agency or other association within the meaning of the common law or under the laws of the jurisdiction in which any Party is incorporated, organized or conducting business.

7.15 Further Assurances. In connection with this Agreement and all transactions contemplated by this Agreement, each Party hereto agrees to execute and deliver such additional documents and instruments as may be reasonably required for a Party to provide or receive the Services hereunder and to perform such other additional acts as may be reasonably necessary or appropriate to effectuate, carry out, and perform all of the terms and provisions of this Agreement.

7.16 Time is of the Essence. Time is of the essence with respect to all time periods and dates set forth herein with respect to the performance of the Services (including Annex A) and the dispute procedures described herein.

7.17 Use of Name. Nothing in this Agreement shall be considered to authorize either Party to use the name, insignia, logo, trademark, trade name, abbreviation, nickname, or other identifying terms or mark (collectively the “Name”) of the other Party, its Affiliates, employees or staff in any manner, except as required by Law.

[Signature Pages Follow]

IN WITNESS WHEREOF, the Parties have executed or caused this Agreement to be duly executed by an authorized officer as of the Effective Date.

MDx:
MDxHealth SA
By:
Name:
Title:
MDxHealth, Inc.
By:
Name:
Title:
Exact:
Exact Sciences Corporation
By:
Name:
Title:
GHI:
Genomic Health, Inc.
By:
Name:
Title:

[Signature Page to Transition Services Agreement]

ANNEX A

Services

MDx Laboratory Test Stand-Up:

Set forth on Schedule 2 appended to this Annex A is an outline of the development plan and timeline (the “LDT Development Plan”) for the development, verification and validation of a diagnostics qPCR assay based on and incorporating the patents, trade secrets and know-how acquired by MDx from GHI pursuant to the Purchase Agreement (the “Prostate Assay”). Referenced in the LDT Development Plan is the technical advice, guidance, training, deliverables and other Services to be provided by the Service Providers to support MDx’s development, verification and validation of the Prostate Assay.

The schedule for performance of the LDT Development Plan and associated Services to be performed by the Service Providers to support the completion of the LDT Development Plan is set forth in Schedule 2, with week 1 of the LDT Development Plan to commence on or before August 15, 2022, and the core Services to be provided under Phase 1 of the plan, targeted for completion during week 15 of the LDT Development Plan. Additional Services on an as needed basis, under Phase 2 of the LDT Development Plan, are expected to be completed at week 36 of the LDT Development Plan.

For the avoidance of doubt, the timelines and content set forth on Schedule 2, including without limitation, Service Providers’ tasks, roles, and the “Supporting Information, Processes & Knowledge Transfer” are for illustrative purposes only, and the failure of the Parties to meet such timelines or adhere to the content and corresponding obligations set forth therein shall not in any way constitute a breach by the Service Providers of their obligations under the Agreement.

ATTACHMENT 1

Business Associate Agreement

[Attached]

Exhibit G

Form of Reference Laboratory Services Agreement

Execution Copy

REFERENCE LABORATORY SERVICES AGREEMENT

This REFERENCE LABORATORYSERVICES AGREEMENT (this “Agreement”) between Genomic Health, Inc., a Delaware corporation (“GHI”), and MDxHealth, Inc., a Delaware corporation (“MDx”), is made as of August 2, 2022 (the “Effective Date”). GHI and MDx are sometimes referred to herein individually as a “Party” and collectively as the “Parties.” Capitalized terms used but not defined herein will have the meanings ascribed to such terms in the Purchase Agreement (as defined below).

Recitals

WHEREAS, GHI and MDxHealth SA, the parent of MDx (“Parent”), are parties to that certain (a) Asset Purchase Agreement of even date herewith (the “Purchase Agreement”), pursuant to which MDx acquired certain Purchased Assets related to the Test (as defined below) and (b) Transition Services Agreement of even date herewith (the “Transition Services Agreement”), pursuant to which GHI agreed to perform, or cause its Affiliates to perform, certain services for MDx on a transitional basis following the Closing;

WHEREAS, GHI operates a duly licensed and accredited clinical testing laboratory (the “GHI Lab”); and

WHEREAS, MDx operates a duly licensed and accredited clinical testing laboratory and desires to engage GHI to serve MDx as a specialty reference lab to provide the Services (as defined below) to MDx Customers at the GHI Lab pursuant to the terms of this Agreement,

NOW, THEREFORE, in consideration of the mutual representations, warranties and agreements contained in this Agreement, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:

Article 1 Additional Definitions

“CAP” means the College of American Pathologists.

“CLIA” means the Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. § 263a) and implementing regulations (42 C.F.R. Part 493).

“GHI Test Fee Schedule” means the price that MDx will pay GHI for GHI’s performance of Tests pursuant to this Agreement. The GHI Test Fee Schedule is attached hereto and incorporated herein by reference as Exhibit B.

“Fair Market Value” means for general valuation purposes, the price at which property, goods or services would change hands between a hypothetical willing and able buyer and a hypothetical willing and able seller, acting at arm’s-length in an open and unrestricted market, when neither is under compulsion to buy or sell and when both have reasonable knowledge of the relevant facts. For purposes of this Agreement, Fair Market Value, for the GHI Test Fee Schedule, shall be calculated as follows: [***] average cost of goods sold plus [***].

“Material PerformanceFailure” means a total stoppage by GHI in the performance of Tests for any period of [***] days, other than as a result of a Force Majeure Event or a material breach by MDx of its obligations hereunder.

“MDx Customers” means persons authorized to order the Test under applicable Laws.

“Payor” means an insurer, including all federal and state health plans or programs, patient, employer or union group, health maintenance organizations, health care service contractor, preferred provider organization, medical group, associates, trust fund or other third party purchaser of laboratory testing services.

“Regulatory Approval(s)” means all approvals (including supplements and amendments thereto), clearances, licenses, registrations, exemptions, or authorizations of any national, supra-national, regional, state or local regulatory agency, department, bureau, commission, council or other Governmental Authority or Person necessary for the commercialization of the Test, and satisfaction of all applicable regulatory and notification requirements.

“Regulatory Authority” means, in a particular jurisdiction, any applicable authority involved in granting Regulatory Approval in such jurisdiction, including, but not limited to CMS and CAP.

“Test” means the Oncotype DX Genomic Prostate Score test, as it exists as of the Effective Date, and as modified from time to time in accordance with this Agreement.

“Transition ServicesPeriod” means the period beginning on the Effective Date and ending on the earlier of (i) December 31, 2022 and (ii) the date the Transition Services Agreement expires or is terminated.

“VA Agreement” means the Veterans Affairs Services License Agreement between GHI and Parent of even date herewith.

Article 2 GHI Responsibilities.

2.1 Provision of Services.

Subject to the terms and conditions of this Agreement, MDx hereby engages GHI to perform and provide analysis for Tests for MDx’s Customers as specifically requested by MDx (the “Services”), as more fully set forth on Exhibit A. GHI shall perform the Services hereunder with the same degree of care and diligence that GHI performed the Services prior to the date of this Agreement.

2.2 Professional and Regulatory Standards.

(a) GHI shall perform the Test when and as requested by MDx in a reasonable, professional manner consistent with regulatory and industry standards and shall comply in all material respects with GHI’s quality and operating standards applicable to the Test as of the Effective Date (as the same may be amended in the reasonable discretion of GHI, with prior notice to MDx of any material changes) (the “Test QA/QS Procedures”).

(b) GHI represents and warrants that its testing facilities are and shall remain duly licensed clinical laboratories under applicable Law qualified to perform the Test. GHI shall comply with applicable standards under CLIA and CAP in all material respects. GHI shall provide immediate written notice of any change to its licensure, certification or accreditation status. GHI shall remain duly enrolled in applicable Federal Healthcare Programs at all times throughout the Term.

(c) GHI further agrees to comply in all material respects with (i) any other applicable required regulations imposed by a Regulatory Authority subject to its authority to regulate the Test, and (ii) applicable conditions imposed by Payors for coverage of the Test.

(d) In the event of any material breach of this Agreement by GHI with respect to the provision of any Services (with respect to which GHI can reasonably be expected to re-perform in a commercially reasonable manner), then GHI will perform or re-perform such Services upon written request (e.g., via email) from MDx on an expedited basis (but in no event later than two (2) Business Days after receipt of such request), and at no additional cost to MDx. Any request for re-performance pursuant to this Section 2.20 must be in writing (including email) and specify in reasonable detail the particular error, defect or breach, and such request must be made no more than ten (10) days from the date on which such breach was discovered by MDx, provided that any delay in giving such notice shall not affect GHI’s obligation to re-perform under this Section 2.2(d) unless, and solely to the extent that, such delay has materially and adversely affected GHI. For avoidance of doubt, Tests that are identified and selected for re-performance in the ordinary course in accordance with applicable Test QA/QS Procedures (e.g., due to contaminated, spoiled, faulty or otherwise inadequate sample, or missing information), shall not be considered a breach of this Agreement.

2.3 Receipt and Processing of Patient Specimens.

MDx shall provide, or shall direct MDx Customers to provide, all patient specimens to GHI accompanied by a fully completed laboratory test requisition from an MDx Customer. Upon receipt, GHI will be responsible for all accessioning and processing of patient specimens for the Test. MDx will work in good faith to secure appropriate Test requisition documentation from MDx Customers, supported by GHI during the Transition Services Period as necessary and to the extent consistent with the terms of this Agreement and the Transition Services Agreement.

2.4 Supplies.

During the Transition Services Period, GHI will provide, as part of its charges for Services, to MDx Customers on MDx’s behalf such patient specimen collection supplies as are integral to and used solely for the collection of patient specimens to permit order completion and submission of patient specimens for the Test, subject to the terms of Section 3.5 of this Agreement. Upon expiration of the Transition Services Period, GHI will cease providing patient specimen collection supplies to MDx Customers as part of the Services hereunder, and MDx shall be solely responsible for providing or arranging for the provision of such patient specimen collection supplies, and the fees thereafter paid to GHI during the Term shall be adjusted in accordance with the GHI Test Fee Schedule. The type and amount of such supplies will be reasonable and appropriate and provided in accordance with applicable Healthcare Regulatory Laws.

2.5 MDx Access.

GHI will provide MDx with reasonable access to its CLIA laboratory director and licensed laboratory professionals when and as reasonably needed for MDx to manage its responsibilities under this Agreement, and GHI laboratory staff will be reasonably available to consult with MDx (and MDx Customers, as necessary during the Transition Services Period) by telephone during normal working hours to discuss GHI laboratory procedures and explain Test results.

Article 3 MDx Responsibilities.

3.1 Payment to GHI for Tests.

As full compensation for all Tests performed by GHI under this Agreement, MDx shall pay GHI in accordance with the GHI Test Fee Schedule set forth as Exhibit B. In addition, MDx shall compensate GHI for the services of a laboratory support manager, as further described in Exhibit A, at the rate set forth in Exhibit B. GHI shall provide MDx with a report listing each Test performed by GHI during each calendar month and an invoice for the fees for such Tests. Payment for each invoice will be due within thirty (30) days after the receipt of the monthly report and the related invoice. In the event of any late payment of any undisputed amount due hereunder, the amount of such late payment shall bear interest at the lesser of (a) the thirty (30) day U.S. Dollar LIBOR rate effective for the date that payment was due, as published by the Wall Street Journal (and in the event that the LIBOR rate is undeterminable, a mutually agreed upon benchmark interest rate), plus an additional one percent (1%) or (b) the maximum rate permitted by Law.

3.2 Billing by MDx.

As between GHI and MDx, MDx will be solely responsible for billing and collecting fees from its patients, MDx Customers, and third-party Payors for all Services performed by GHI hereunder. MDx shall perform this Agreement and all activities related thereto, including all billing and collection activities hereunder in accordance with (a) applicable Law, including, but not limited to accreditation requirements and laws relating to direct billing, anti-markup, and disclosures; and (b) applicable contractual requirements with Payors.

3.3 Regulatory Approvals, Consents & Authorizations.

MDx shall (a) maintain all Regulatory Approvals from all applicable Governmental Authorities and any non-governmental Persons to the extent required under applicable Law for its performance of this Agreement; and (b) obtain all consents and authorizations from its patients, MDx Customers or others as may be required by applicable Laws to enable GHI to perform the requested Services and report the results thereof. Upon request, MDx shall provide GHI with a copy of such Regulatory Approvals, consents and authorizations.

3.4 Authorized Provider.

MDx shall ensure that all requested services are being ordered by a person authorized under applicable Law to order the Services.

3.5 Collection; Return of Reports.

MDx shall either directly or indirectly oversee, and be responsible for the collection and delivery of patient specimens to GHI to be tested together with a test order that satisfies Section 2.3 hereof. MDx shall bear sole responsibility for ensuring patient specimens of sufficient quantity and quality are submitted to GHI to permit successful testing, and that all specimens delivered to GHI are clearly labeled with information identifying MDx’s Customer and the patient, provided that GHI shall bear responsibility for any deficiencies in specimen quality, delivery, and labeling solely resulting from defects or other deficiencies in specimen collection supplies furnished by GHI pursuant to Section 2.4 hereof. In the event that ordering information is incomplete or the specimen sample is insufficient for GHI to obtain satisfactory test results, GHI shall contact MDx to resolve in accordance with GHI’s routine policies and procedure and consistent with past practice, and, to the extent necessary solely during the Transition Services Period, may contact the ordering physician to resolve, consistent with the terms of the Transition Services Agreement. During the Transition Services Period, the fees paid to GHI hereunder shall cover and include all costs associated with collection and delivery of specimens to the GHI Lab. After the end of the Transition Services Period, MDx shall be solely responsible for all costs associated with collecting and delivering specimens to the GHI Lab. The process for return of Test reports shall be as set forth in Exhibit A.

3.6 Medicare Referring Laboratory Cap.

MDx acknowledges that it is subject to Section 1833(h)(5)(A) of the Social Security Act which provides that a referring laboratory may bill Medicare for clinical laboratory diagnostic tests for Medicare beneficiaries performed by a reference laboratory only if the referring laboratory meets certain conditions, including, without limitation, that the referring laboratory does not refer more than thirty percent (30%) of the total number of clinical laboratory tests (regardless of the patient’s Payor status) for which it receives requests for testing during the year in which the billed test is performed (the “30% Cap Limitation”).MDx agrees to routinely monitor tests it refers to reference laboratories and to comply with the 30% Cap Limitation. MDx acknowledges and agrees that non-compliance with the 30% Cap Limitation shall constitute a material breach of this Agreement.

3.7 Non-Binding Forecasts.

No less than thirty (30) days prior to the beginning of each calendar quarter commencing after December 31, 2022, MDx shall submit to GHI a non-binding forecast of the expected volume of Services during such calendar quarter. Such forecasts are for planning purposes only, and do not constitute, and are not intended by the Parties to be, a commitment or obligation of MDx to request any amount of Services during such calendar quarter, and, without limiting MDx obligations with respect to the 30% Cap Limitation in Section 3.6, shall not impose a limitation on the volume of Services that MDx may request during such calendar quarter.

3.8 Transition of Services.

As promptly as reasonably practicable following the execution of this Agreement, MDx agrees to use good faith efforts to transition the Services to its own internal organization. The Parties shall cooperate and coordinate in good faith to facilitate a smooth transition from the provision of Services by GHI to the provision of Services by MDx, as set forth in the Transition Services Agreement and any other applicable Ancillary Documents.

Article 4 Cooperation; Mutual Rights andResponsibilities.

Article 4 4.1 Records; Audits.

Each Party shall maintain, or cause to be maintained, records of activities with respect to the Test in sufficient detail and in good scientific manner appropriate for regulatory purposes and for quality control of the Test. All such records shall be complete and accurate and shall be retained for such period as may be required by applicable Laws or as required by either Party’s corporate record retention policies, whichever is longer. Upon reasonable notice, not to exceed once per year, each Party shall have the right, at mutually agreed times during normal business hours, to obtain from the other Party access to and copies (at its own cost) of such records maintained by the other Party for purposes of this Section 4.1.

4.1 Safety Data.

Each Party shall provide to the other Party all relevant information concerning any product complaints as well as any serious adverse effect on health or safety caused by, or associated with, the use of the Test. In the case of GHI reporting such information to MDx, GHI shall provide such information in a timely manner in order to permit MDx to evaluate and report such events to Regulatory Authorities as may be required by applicable Laws. In the event either Party becomes aware of serious adverse events that relate to the Test, at the request of either Party (or if otherwise required by applicable Law), the Parties shall cooperate in good faith to enter into an agreement to provide for additional safety data reporting procedures.

4.2 License of Intellectual Property.

(a) MDx hereby grants to GHI and its Affiliates during the Term a non-exclusive, royalty-free, non-transferable, non-sublicensable license to use the Business Intellectual Property Assets (excluding such assets as defined in clauses (d), (h) and (i) of the definition of Intellectual Property in the Purchase Agreement and clauses (i) and (ii) of the definition of Business Intellectual Property Assets in the Purchase Agreement) solely to provide the Services hereunder, including to make, use, copy, modify, distribute, display, offer to provide and provide the Services, and otherwise exploit such Business Intellectual Property Assets to provide the Services hereunder. MDx reserves all rights not expressly granted to GHI under this Agreement. As between the parties, MDx owns any improvement, enhancement, or other modification of the Business Intellectual Property Assets made by or on behalf of either Party (“Modification”). Modifications include, but are not limited to, copyrightable works of original authorship, ideas, inventions (whether patentable or not), “know how,” processes, compilations of information, trademarks and other intellectual property, but excludes all Confidential Information and Excluded Assets of GHI (after giving effect to the transactions consummated at the Closing). GHI hereby assigns to MDx all of its right, title, and interest in and to all Modifications, including all rights to apply for any patents or other intellectual property registrations with respect to such Modifications and all enforcement rights and remedies for past, present, and future infringement thereof and all rights to collect royalties and damages therefor. All intellectual property rights in any Modification, including patent, trademark or copyright applications and applications for registration filed by MDx, shall automatically be subject to the license granted in this Section 4.3. GHI has engaged and will engage employees, approved subcontractors and/or consultants (“GHI Personnel”) with the proper skill, training and experience to perform the Services. GHI will be solely responsible for paying GHI Personnel and providing any employee or other benefits that they are owed. Before providing Services, all GHI Personnel must have agreed in writing to (a) confidentiality and non-use obligations consistent with the terms of this Agreement, and (b) assign or otherwise effectively vest in GHI any and all rights that such personnel might otherwise have in the results of their work under this Agreement.

4.3 Software Ownership. MDx acknowledges and agrees that: (a) nothing in this Agreement (including the provision of Services hereunder) will be construed as transferring any ownership interest in any software of any third parties or any licenses thereto made available to MDx by GHI in connection with the provision of the Services (“Third Party Software”), or any proprietary software of GHI or its Affiliates used in connection with the provision of the Services (“GHI Proprietary Software”); (b) it will not obtain or claim any right, title or ownership interest in any Third Party Software or GHI Proprietary Software, or any portion thereof or any intellectual property rights therein; and (c) GHI and its Affiliates (or the third party owners, as applicable) will retain all right, title and interest, including all intellectual property rights, in and to all portions of the Third Party Software and GHI Proprietary Software, and any modifications, derivative works, and copies thereof. MDx may not recompile, decompile, disassemble, reverse engineer, or make or distribute any other form of, or any derivative work from, any Third Party Software or GHI Proprietary Software.

4.4 Non-Exclusivity.

Nothing in this Agreement shall prevent MDx from contracting with other Persons to provide the same or similar services as provided by GHI hereunder, including with respect to the Test. Nothing in this Agreement shall prevent GHI from offering and/or performing reference laboratory services for any other Person, provided that GHI may not perform the Test for any other Person (other than pursuant to the VA Agreement). GHI acknowledges and agrees that any Services provided by GHI otherwise than pursuant to this Agreement or the VA Agreement shall constitute a material breach of this Agreement.

Article 5 Compliance with Laws.

5.1 Compliance with Law.

(a) The Parties expressly acknowledge that it has been, and continues to be their intent, to comply fully with, and the Parties shall fully comply with, all applicable Laws. Each Party acknowledges and agrees that it has relied upon the representations and warranties of the other set out in this Agreement as a precondition to enter into this Agreement, and each Party has reasonably relied upon the representations and warranties of the other Party by entering into this Agreement. Specifically, the Parties acknowledge and agree that all personnel involved in the performance or reporting of the Test shall have obtained and shall maintain at all times during the Term all applicable qualifications, licenses, registrations and permits as required by Healthcare Regulatory Laws applicable to the provision of the Test.

(b) The Parties agree that it is neither a purpose nor a requirement of this Agreement or any other agreement between the Parties to offer or receive any remuneration or benefit of any nature for the referral of, or to solicit, require, induce, or encourage the referral of any patient, customer, item, or business (including the Test) for which payment may be made or sought in whole or in part by any Federal Healthcare Program. This Agreement has been prepared to comply, to the fullest extent possible, with all applicable Healthcare Regulatory Laws. GHI shall not, as part of the Services, engage in any marketing or promotional activities with the intent to encourage or solicit referrals or orders of the Test by ordering providers, and MDx will not request GHI to engage in the same.

(c) All compensation and payments provided hereunder and according to Exhibit B have been negotiated at arm’s length and represent Fair Market Value for the Test provided by GHI and GHI’s obligations under this Agreement. No payment made or received under this Agreement is in return for the referral of patients or customers, or in return for the purchasing, leasing, ordering, arranging for, or recommending the purchasing, leasing, or ordering of any good, service, item, or product for which payment may be sought in whole or in part from Federal Healthcare Programs. The compensation contemplated under this Agreement is solely intended to compensate GHI for its costs and expenses related to Services rendered under this Agreement and neither this Agreement nor the compensation paid hereunder or otherwise is based on, takes into account, or is contingent upon the referral of any patients or customers, or the volume or value of referrals or other business generated between the Parties for which payment may be sought in whole or in part from any Federal Healthcare Program.

(d) In connection with the provision of the services provided hereunder, each Party may have access to certain protected health information (“PHI”) as defined by the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and the Health Information Technology for Economic and Clinical Health Act, and all implementing regulations, as each may be amended, modified, or superseded from time to time. Both Parties acknowledge that each party is a “covered entity” as that term is defined at 45 C.F.R. § 160.103 and that disclosures of PHI pursuant to this Agreement are pursuant to the treatment exception under HIPAA. All Parties agree to maintain the confidentiality of PHI and other personally identifiable information in accordance with HIPAA and applicable state and federal privacy and security Laws, and not to disclose such information except as may be required or permitted by applicable Law.

5.2 Access to Books and Records.

If the Services provided by GHI hereunder are subject to the disclosure requirements of 42 U.S.C. § 1395x(v)(1)(I) or other applicable Law, GHI shall, for the required period of time, make available, upon written request of the Secretary of Health and Human Services, the Comptroller General, or any of their duly authorized representatives, a copy of this Agreement and the books, documents and records of GHI that are necessary to certify the nature and extent of the costs incurred under this Agreement through a subcontractor with a value or cost of $10,000 or more over a twelve month period. In addition, with respect to any applicable subcontract, it shall contain a clause to the effect that, should the third-party be deemed a related organization, until the expiration of the applicable period of time after the furnishing of services pursuant to such subcontract, the third-party shall make available, upon such a request, a copy of the subcontract, and the books, documents and records of such third-party that are necessary to verify the nature and extent of the costs incurred under this Agreement.

5.3 Statement of Intention.

The Parties intend that all payments by MDx for the Test hereunder shall at all times be in compliance with all applicable Laws and consistent with the Fair Market Value for the Test. Accordingly, if either Party reasonably determines at any time or is reliably informed by a Governmental Authority that the compensation arrangements set forth herein violate or are likely to be determined by a third party to violate such Laws, the Parties agree to meet immediately and in good faith to amend this Agreement so as to eliminate such concern or violation and to bring this Agreement into compliance with the foregoing. Any such amendment shall have the same aggregate economic effect within lawful guidelines, as between the Parties. Such determination, information, or amendment shall not allow either Party to claim that this Agreement is void or voidable.

5.4 Change in Law.

In the event of any applicable legislative or regulatory change or action by any Governmental Authority, whether federal or state, that has or would have a significant adverse impact on either Party hereto in connection with the performance of services hereunder, or should either Party be deemed for any reason in violation of any statute or regulation arising from this Agreement, or should it be determined that this Agreement is prohibited by applicable Law, then the Parties agree to meet immediately to work in good faith to resolve such issue, including, if required, amending this Agreement so as to eliminate such concern or violation and bring this Agreement into compliance with the foregoing.

Article 6 Representations, Warranties and Covenants.

6.1 Authority.

Each Party represents to the other Party that (a) it has the corporate power and authority and the legal right to enter into this Agreement and perform its obligations hereunder; (b) it has taken all necessary corporate action on its part required to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder; and (c) this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, and binding obligation of such Party that is enforceable against it in accordance with its terms.

6.2 No Conflict.

The execution, delivery and performance of this Agreement by each Party does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it is bound, nor violate any law or regulation of any court, governmental body, Regulatory Authority or administrative or other agency having jurisdiction over it.

6.3 Enforceability.

Each Party represents and warrants to the other Party that, as of the Effective Date, this Agreement is a legal and valid obligation binding upon the warranting Party and is enforceable against it in accordance with its terms.

6.4 Debarment.

Each Party represents and warrants that neither it nor any of its employees, agents or Affiliates is excluded under 42 U.S.C. §1320(a)-7 from participation under any Federal Healthcare Program for the provision of items or services for which payment may be made under a Federal Healthcare Program (“Exclusions/Adverse Actions”). During the Term, each Party agrees to promptly notify the other Party in writing of any actual or threatened Exclusions/Adverse Actions. Each Party acknowledges that the exclusion of any of its personnel from participation in the Medicare or Medicaid programs shall result in his or her immediate removal from work under this Agreement. Each Party acknowledges and agrees that any unresolved Exclusions/Adverse Actions of or against it or any employee, agent or independent contractor utilized, directly or indirectly, in the performance of this Agreement may serve as the basis for the termination of this Agreement by the other Party.

6.5 Exclusive Remedies; Limitations; Survival. EXCEPT AS SET FORTH IN SECTION 8.3, THE REMEDIES DESCRIBED IN THIS SECTION 6.5 AND SECTIONS 6.6, 7.1 AND 7.2 ARE THE SOLE AND EXCLUSIVE REMEDIES OF THE PARTIES WITH RESPECT TO THE MATTERS SET FORTH IN SECTIONS 6.6, 7.1 AND 7.2, AS APPLICABLE. EXCEPT AS PROVIDED IN SECTION 6.6 BELOW, IN NO EVENT WILL EITHER PARTY BE LIABLE TO THE OTHER PARTY UNDER OR IN CONNECTION WITH THIS AGREEMENT FOR ANY REMOTE, INDIRECT, SPECULATIVE, CONSEQUENTIAL, SPECIAL, INCIDENTAL, EXEMPLARY OR PUNITIVE DAMAGES (INCLUDING LOST PROFITS OR SALES) ARISING FROM OR RELATED TO THE SERVICES, EVEN IF ADVISED OF THEIR POSSIBLE EXISTENCE. THE ALLOCATIONS OF LIABILITY IN THIS ARTICLE 6 REPRESENT THE AGREED AND BARGAINED-FOR UNDERSTANDING OF THE PARTIES WITH RESPECT TO THE ALLOCATION OF RISKS ARISING HEREUNDER. THE OBLIGATIONS OF THE PARTIES PURSUANT TO THIS SECTION 6.5 WILL SURVIVE THE EXPIRATION OR OTHER TERMINATION OF THIS AGREEMENT FOR A PERIOD OF ONE YEAR.

6.6 Consequential Damages. Notwithstanding anything to the contrary in Section 6.5, GHI acknowledges and agrees that (a) pursuant to the Purchase Agreement, MDx has acquired the Business from GHI for the consideration specified therein, (b) the independent operation of the Business by MDx will require substantial time and investment to establish and validate a clinical laboratory to offer the Test, (c) neither MDx, nor any party other than GHI, currently has the capability to offer the Test, (d) in the absence of this Agreement, MDx would be unable to operate the Business, (e) as a result of the foregoing, direct damages would not be an adequate remedy for any material breach of this Agreement, and (f) as a result, GHI agrees that it shall be liable not only for any and all direct damages but also for any and all consequential, special and incidental damages (other than exemplary or punitive damages in a direct action by MDx), including damages for interruption of business, lost profits or sales, impairment of goodwill, impairment of intangible assets and other losses in value (collectively, “Consequential Damages”), in each case, sustained or incurred by MDx arising from or relating to any Material Performance Failure (but, for avoidance of doubt, not from any other breach of this Agreement); provided, however, that MDx may recover Consequential Damages only by means of set-off against any Earn-Out Consideration (as defined in the Purchase Agreement) that becomes due and payable under the Purchase Agreement after the Material Performance Failure (but, for avoidance of doubt, not from any Earn-Out Consideration that is unpaid but became due and payable before the Material Performance Failure).

6.7 Representation; Disclaimer. GHI represents and covenants that it will comply in all material respects with all Laws applicable to its performance of this Agreement and the conduct of the Services hereunder. GHI HEREBY EXPRESSLY DISCLAIMS ALL WARRANTIES FOR MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE WITH RESPECT TO THIS AGREEMENT, THE SERVICES AND ANY RESULTS THEREOF.

Article 7 Indemnification; Insurance.

Indemnification by GHI.

GHI shall defend, indemnify and hold MDx and its officers, directors, employees and agents harmless from and against any and all actual or alleged claims, suits, proceedings, damages, expenses (including court costs and reasonable attorneys’ fees and expenses), losses, liabilities, judgments, settlements, interest, awards, penalties, fines, costs and recoveries, of whatever kind (collectively, “Claims”), to the extent that such Claims arise out of, are based on, or result from (a)-(d) (inclusive) below, except in any case to the extent such Claim is caused by MDx’s or its Affiliates’, employees’ or agents’ negligence, willful misconduct or breach of this Agreement:

(a) any breach of GHI’s representations, warranties, or obligations under this Agreement;

(b) the willful misconduct, negligent acts, or violation of any Laws by GHI, its Affiliates or the officers, directors, employees or agents of GHI or its Affiliates under this Agreement;

(c) GHI’s use of Third Party Software in the provision of the Services hereunder breaches the intellectual property rights of a third party; and

(d) GHI’s performance of the testing and analytical services under this Agreement.

7.2 Indemnification by MDx.

MDx shall defend, indemnify and hold GHI and its officers, directors, employees and agents harmless from and against any and all actual or alleged Claims, to the extent that such Claims arise out of, are based on, or result from (a)-(d) (inclusive) below, except in any case to the extent such Claim is directly caused by GHI’s or its Affiliates’, employees’ or agents’ negligence, willful misconduct or breach of this Agreement:

(a) MDx’s use of the Test results;

(b) MDx’s billing and collection activities related to the Test;

(d) the willful misconduct or negligent acts, or violation of any Laws by MDx, its Affiliates or the officers, directors, employees or agents of MDx or its Affiliates under this Agreement.

7.3 Indemnification Procedures.

A Party claiming indemnity under this Article 7 (the “Indemnified Party”) shall give written notice to the Party from whom indemnity is being sought (the “Indemnifying Party”) promptly after learning of such Claim; provided that the failure to give such written notice shall not affect the right of the Indemnified Party to indemnity hereunder unless, and solely to the extent that, such failure has materially and adversely affected the rights of the Indemnifying Party. The Indemnified Party shall provide the Indemnifying Party with reasonable assistance, at the Indemnifying Party’s expense, in connection with the defense of the claim for which indemnity is being sought. The Indemnifying Party shall have the right to assume and conduct the defense of the claim with counsel of its choice; provided the Indemnified Party may participate in and monitor such defense with counsel of its own choosing, such counsel to be employed at the Indemnified Party’s sole cost and expense unless the interests of the Indemnified Party and the Indemnifying Party with respect to such Claim are sufficiently adverse to prohibit the representation by the same counsel of both Parties under applicable Law, ethical rules or equitable principles (in which case, the Indemnified Party shall control its defense, with the out-of-pocket costs and expenses including attorney’s fees with respect thereto borne by the Indemnifying Party); provided further, that the Indemnifying Party shall obtain the prior written consent (such consent to not be unreasonably withheld, delayed or conditioned) of any such Indemnified Party as to any settlement which would require an admission of legal wrongdoing in any way on the part of an Indemnified Party, or would otherwise materially adversely affect the Indemnified Party. So long as the Indemnifying Party is actively defending the claim in good faith, the Indemnified Party shall not settle or offer to settle any such claim without the prior written consent of the Indemnifying Party. If the Indemnifying Party does not assume and conduct the defense of the claim as provided above, (1) the Indemnified Party may defend against, and consent to the entry of any judgment or enter into any settlement with respect to the claim in any manner the Indemnified Party may deem reasonably appropriate (and the Indemnified Party need not consult with, or obtain any consent from, the Indemnifying Party in connection therewith), and (2) the Indemnifying Party will remain responsible to indemnify the Indemnified Party as provided in this Article 7.

7.4 Insurance.

Each Party will maintain at its sole cost and expense, an adequate liability insurance or self-insurance program (including product liability insurance) to protect against potential liabilities and risk arising out of activities to be performed under this Agreement and any agreement related hereto and upon such terms (including coverages, deductible limits and self-insured retentions) as are customary in the US diagnostic testing industry for the activities to be conducted by such Party under this Agreement, and in all events appropriate for the foreseeable risks inherent in the commercialization and use of the Test, as applicable. Upon request of either Party, the other Party will provide proof of insurance or loss coverage required under the terms of this Agreement. In addition, each Party agrees to notify the other Party in writing in the event of material modification or change in such coverage.

Article 8 Confidentiality; Non-Solicitation.

8.1 Confidentiality.

(a) Confidential Information. From time to time during the Term, the Parties or their Affiliates may disclose or make available (as the “Disclosing Party”) to another Party or its Affiliates (as the “Receiving Party”) information about the Disclosing Party’s (or the Disclosing Party’s Affiliates’) business or affairs, including information relating to the Business, clinical information, customers, clients, suppliers, vendors, investors, lenders, consultants, independent contractors or employees, price lists and pricing policies, financial statements and information, budgets and projections, business plans, production costs, market research, marketing, sales and distribution strategies, manufacturing techniques, processes and business methods, technical information, pending projects and proposals, new business plans and initiatives, research and development projects, inventions, discoveries, ideas, technologies, trade secrets, know-how, formulae, designs, patterns, marks, names, improvements, industrial designs, mask works, works of authorship and other Intellectual Property, devices, samples, plans, drawings and specifications, photographs and digital images, computer software and programming, the terms of this Agreement, all other confidential information and materials relating to its business or affairs, and all notes, analyses, compilations, studies, summaries, reports, manuals, documents and other materials that ought reasonably to be considered confidential prepared by or for the Disclosing Party (or its Affiliates) containing or based in whole or in part on any of the foregoing, whether in verbal, written, graphic, electronic or any other form, whether or not conceived, developed or prepared in whole or in part by the Disclosing Party and whether or not marked as confidential (collectively, “Confidential Information”). For clarity, the Parties acknowledge and agree that the Business Intellectual Property Assets shall be the Confidential Information of MDx.

(b) Exclusions. Confidential Information does not include information that, the Receiving Party can demonstrate with competent written records: (i) was publicly known at the time of disclosure, or has become publicly known through no breach of this Agreement or the Ancillary Documents by Receiving Party or its Representatives; (ii) was rightfully obtained by the Receiving Party on a non-confidential basis from a third party that was in lawful possession of such information and not under any obligations of confidentiality regarding such information; or (iii) independently developed by the Receiving Party without reference to or use of any the Disclosing Party’s Confidential Information and that can be demonstrated by the Receiving Party through contemporaneous written records.

(c) Protection of Confidential Information. The Receiving Party will safeguard the Confidential Information from unauthorized use, access, or disclosure using at least the degree of care it uses to protect its own confidential information and in no event less than a reasonable degree of care. The Receiving Party may use Confidential Information only for the purposes of fulfilling its obligations under this Agreement and enforcing its rights under this Agreement. The Receiving Party will not disclose the Disclosing Party’s Confidential Information to any person or entity, except: (a) to the Receiving Party’s employees, Affiliates and subcontractors who have a need to know the Confidential Information for the sole purpose of fulfilling Receiving Party’s obligations under this Agreement and who have been advised of the terms of this Section 8.1 and are bound by written obligations of confidentiality no less restrictive than the obligations of confidentiality herein or (b) to the limited extent required in order to comply with the order of a court or other Governmental Authority, or as otherwise necessary to comply with applicable Law, provided that the Receiving Party will promptly provide the Disclosing Party with prior written notice so that the Disclosing Party may seek a protective order, provide reasonable assistance to the Disclosing Party in seeking such an order and will limit disclosure of such Confidential Information to only that portion of the Confidential Information which is required to be disclosed; provided that any Confidential Information so disclosed shall maintain its confidentiality protection for all purposes other than such legally compelled disclosure. Receiving Party will be liable for any breach of these confidentiality provisions by its Representatives.

(d) Return or Destruction of Confidential Information. On the expiration or termination of this Agreement or at the Disclosing Party’s written request, the Receiving Party will promptly return to the Disclosing Party all copies, whether in written, electronic, or other form or media, of the Disclosing Party’s Confidential Information, or at Disclosing Party’s written direction destroy all such copies and certify in writing to the Disclosing Party that such Confidential Information has been destroyed. Notwithstanding the foregoing, the Receiving Party may retain a copy of the Disclosing Party’s Confidential Information (a) to the extent and for so long as required by applicable Law, and (b) held electronically in archive or backup systems in accordance with general systems archiving and backup policies; on the condition that, in each instance, all such retained Confidential Information remains subject to the provisions of this Section 8.1.

(e) Survival. The obligations imposed by this Section 8.1 will survive the termination or expiration of this Agreement for five (5) years from the date of such termination or expiration; except with respect to Confidential Information that constitutes (i) trade secrets, which will survive the termination or expiration of this Agreement for so long as the trade secret information is treated as trade secret under applicable Law or (ii) Business Intellectual Property Assets.

8.2 Non-Solicitation. MDx will not, and will cause its Affiliates not to, during the Term and for a period of two (2) years thereafter (the “Restricted Period”), directly or indirectly hire or solicit any Person that is or was employed or served as an independent contractor of GHI or its Affiliates as of the Effective Date or during the Restricted Period and (i) was providing Services to MDx pursuant to the terms of this Agreement or (ii) became known to MDx in connection with the transactions contemplated by the Purchase Agreement, or in connection with the Services or performance by the Parties of this Agreement (“Restricted Persons”); provided, that the foregoing will not restrict MDx from hiring the employees or independent contractors of GHI who provide services to the Business, in connection with transactions contemplated by the Purchase Agreement, including Transfer Employees. Notwithstanding the foregoing, nothing in this Section 8.2 will restrict MDx from (a) making any general solicitation for employment that is not directed at the Restricted Persons or hiring any such Restricted Persons who respond to such general solicitations, (b) using the services of personnel recruiting firms provided that MDx does not direct such firms to target GHI, its Affiliates, or the Restricted Persons or hiring any such Restricted Persons who respond to such recruiting firm’s solicitations, or (c) soliciting or hiring any Restricted Person who has not been employed by GHI, or its Affiliates for six months immediately prior to the solicitation or hiring.

8.3 Specific Performance. The Parties agree and acknowledge that money damages may not be an adequate remedy for any breach of the provisions of this Article 8 (and thus waive any defense that there is an adequate remedy at law), and that any Party may in its sole discretion apply to any court of law or equity of competent jurisdiction for specific performance or injunctive relief (without posting a bond or other security) in order to enforce or prevent any violation or threatened violation of the provisions of this Article 8.

Article 9 Term and Termination.

9.1 Term.

This Agreement shall become effective on the Effective Date and shall remain in effect for a period of one (1) year, unless earlier terminated as set forth herein (the “Initial Period”). Thereafter, this Agreement shall renew for up to two (2) six (6) month periods (each a “RenewalPeriod”) unless MDx provides written notice of non-renewal not less than thirty (30) days before the commencement of the applicable Renewal Period , and provided MDx has complied in all respects with its obligations under Section 3.8 as of the time of such renewal. After the second Renewal Period, this Agreement may be renewed through the mutual written agreement of the Parties (each, an “AdditionalRenewal Period” and collectively with the Initial Period and Renewal Periods, the “Term”).

9.2 Notice of Default and Cure Period.

Upon any material breach of this Agreement by a Party (the “Breaching Party”), the other Party (the “Non-Breaching Party”) shall have the right to give the Breaching Party notice specifying the nature of such material breach. If the breach of this Agreement is curable, then the Breaching Party shall have a period of thirty (30) days from the date of receipt of the notice (or such shorter period as shall be specified elsewhere in this Agreement, including Section 2.2(d) and Exhibit A) or such longer period as is agreed by the Parties in writing (the “Cure Period”) to cure such material breach in a manner that effectively remedies the harm to the Non-Breaching Party caused by the material breach. For clarity, this provision shall not restrict in any way either Party’s right to notify the other Party of any other breach or to demand the cure of any other breach.

9.3 Termination for Cause.

The Non-Breaching Party shall have the right to terminate this Agreement, upon written notice to the Breaching Party in the event that the Breaching Party has not cured the material breach within the Cure Period. For the avoidance of doubt, the exercise of a termination right under this Section 9.3 by a Non-Breaching Party shall be without prejudice to its right to seek damages or any other remedy on account of the Breaching Party’s material breach that may be available at law or in equity, subject to the terms hereof.

9.4 Termination by MDx.

MDx may terminate this Agreement upon thirty (30) days’ written notice to GHI for any or no reason. MDx shall terminate this Agreement, by giving written notice of termination to GHI, after both (a) MDx shall have completed all testing and validation of its laboratory for the Test and shall have obtained all applicable Regulatory Approvals to offer the Test to all patients in the United States and (b) the Parties shall have performed their obligations under Section 3.8. MDx shall expend its commercially reasonable best efforts to perform its obligations and achieve the objectives set out under subsections (a) and (b) above.

9.5 Termination Due to Prospective Legal Event

If (a) any applicable Laws are duly passed, adopted or implemented, or there are other changes in applicable Laws; (b) either Party or their respective Affiliates receive notice of an actual or threatened decision, finding or action, including as a result of an audit or investigation by any Governmental Authority; or (c) any Governmental Authority’s interpretation of applicable Law (collectively referred to herein as a “LegalEvent”) which, when implemented, effected or concluded, would materially impact the Parties’ respective or collective ability to perform the Agreement in compliance with applicable Law, as amended, interpreted or enforced in accordance with the Legal Event, and either Party determines in good faith, after consultation with legal counsel, that compliance with the Legal Event while maintaining the originally intended benefits of this Agreement, is impossible or infeasible, this Agreement may be terminated upon thirty (30) days’ written notice from either Party to the other Party; provided, however, the date of such termination shall be no later than the effective date of the Legal Event.

9.6 Effect of Termination; Survival.

All rights and obligations of the Parties which by their nature or the context are intended to continue beyond expiration or termination of this Agreement will survive such termination or expiration, including without limitation: Section 3.1, Section 4.1, Section 4.2, Section 5.1(d), Sections 5.2, Section 6.5, Section 6.6, Article 7, Article 8, Article 10, and Article 11.

Article 10 Dispute Resolution.

10.1 Disputes.

The Parties recognize that disputes as to certain matters may from time to time arise during the Term which relate to either Party's rights and/or obligations hereunder. It is the objective of the Parties to establish procedures to facilitate the resolution of disputes arising under this Agreement in an expedient manner by mutual cooperation and without resort to litigation. To accomplish this objective, the Parties agree to follow the procedures set forth in this Article 10 (except where a different procedure is otherwise specified in this Agreement) to resolve any controversy or claim arising out of, relating to or in connection with any provision of this Agreement, if and when a dispute arises under this Agreement.

10.2 Referral to Chief Executive Officers.

The Chief Executive Officers of each Party shall attempt to resolve any dispute by good faith efforts. If the Chief Executive Officers are not able to resolve such dispute within ten (10) days of the referral of such dispute to the Chief Executive Officers, then, except as otherwise specified in this Agreement, the Parties shall try to resolve such dispute through mediation pursuant to Section 10.3.

10.3 Mediation.

Mediation shall be administered by JAMS in California. The Parties shall use good faith efforts to resolve any disputes referred to mediation as expeditiously as practicable. If the Parties fail to resolve any such dispute through mediation within one hundred-twenty (120) days after the initiation thereof, the dispute shall be resolved by binding arbitration pursuant to Section 10.4.

10.4 Arbitration.

Disputes not resolved by mediation pursuant to Section 10.3 shall be resolved through binding arbitration administered by JAMS, which arbitration may be initiated by either Party after the conclusion of such period, on the following basis:

(a) The place of arbitration shall be California.

(b) The arbitration shall be conducted by three (3) arbitrators, with one selected by each of the Parties and the third mutually agreed upon by the respective individuals selected by the Parties.

(c) The arbitration shall be made in accordance with the Comprehensive Arbitration Rules and Procedures of JAMS then in effect.

(d) The award shall be made in writing, shall be binding on the Parties and may be entered as a judgment by any court or forum having jurisdiction.

(e) Either Party may apply to the arbitrators for interim injunctive relief until the arbitration award is rendered or the controversy is otherwise resolved. Further, either Party also may, without waiving any remedy under this Agreement, seek from any court having jurisdiction any injunctive or provisional relief necessary to protect the rights or property of such Party pending the arbitration award.

(f) The arbitrators shall have no authority to award punitive damages.

(g) Each Party shall bear its own costs in the arbitration, provided, however, that the arbitrators shall be authorized to determine whether a Party is the prevailing Party, and if so, to award to that prevailing Party reimbursement for its reasonable counsel fees and costs and the fees and costs of the arbitrators.

(h) Except to the extent necessary to confirm an award, as may be required by Law or as may be required to be disclosed to a Party's auditors, neither Party nor any arbitrator may disclose the existence, content, or results of an arbitration without the prior written consent of both Parties.

(i) In no event shall an arbitration be initiated after the date when commencement of a legal or equitable proceeding based on the dispute, controversy or claim would be barred by the applicable statute of limitations.

Article 11 Miscellaneous.

11.1 No Third-Party Beneficiaries. Except as expressly set forth in this Agreement, this Agreement does not confer any rights or remedies upon any person or entity other than the Parties and their respective successors and permitted assigns.

11.2 Purchase Agreement; No Set-off. Neither the making nor the acceptance of this Agreement will enlarge, restrict or otherwise modify the terms of the Purchase Agreement or Transition Services Agreement, or constitute a waiver or release by any Party of any liabilities, obligations or commitments imposed upon them by the terms of the Purchase Agreement or Transition Services Agreement, including the representations, warranties, covenants, agreements and other provisions of the Purchase Agreement and the Transition Services Agreement. Each Party, on behalf of itself and each of its Affiliates, agrees that, except as expressly set forth in Section 6.6, (a) its rights and remedies under this Agreement will not give rise to any right of set-off, defense or counterclaim under the Purchase Agreement or any Ancillary Document (other than this Agreement) and (b) any rights and remedies that it or any of its Affiliates may have under the Purchase Agreement or any Ancillary Document (other than this Agreement) will not give rise to any right it may have to set-off, defense or counterclaim under this Agreement.

11.3 Entire Agreement.

This Agreement (together with the attachments hereto), the Purchase Agreement and the other Ancillary Documents (collectively, the “Transaction Agreements”), together, constitute the entire agreement among the Parties with respect to the subject matter hereof and supersedes all prior and contemporaneous agreements (whether written or oral and whether express or implied) among any Parties with respect to the subject matter of the Transaction Agreements. In the event and to the extent that there is a conflict between the provisions of this Agreement and the provisions of any attachment hereto, the provisions of this Agreement will control. Except as specifically set forth herein, in the event and to the extent that there is a conflict between the provisions of this Agreement and the provisions of the Purchase Agreement, the provisions of the Purchase Agreement will control. Except as specifically set forth herein, in the event and to the extent that there is a conflict between the provisions of this Agreement and the provisions of the Transition Services Agreement as it relates to the provision of the Services hereunder, the provisions of this Agreement will control; provided, however, that MDx’s obligations under Section 3.8 of this Agreement shall not be deemed to limit, reduce or otherwise relieve any of GHI’s obligations under the Transition Services Agreement.

11.4 Amendments; No Waivers. No amendment, supplement or other modification of any provision of this Agreement will be valid unless it is in writing and signed by all of the Parties. No waiver of any provision of this Agreement will be valid unless the waiver is in writing and signed by the waiving Party. The failure of any Party at any time to require performance of any provision of this Agreement will not affect such Party’s rights at a later time to enforce such provision. No waiver by any Party of any breach of this Agreement will be deemed to extend to any other breach hereunder or affect in any way any rights arising by virtue of any other breach.

11.5 Successors and Assigns; Assignment. This Agreement will be binding upon and inure to the benefit of the Parties and their respective successors and permitted assigns. No Party may assign, delegate or otherwise transfer (whether by operation of Law, merger, consolidation, amalgamation, sale of assets or equity or otherwise and whether directly or indirectly) this Agreement or any of its rights, interests or obligations in this Agreement, in each case, without the prior written approval of the other Party, which shall not be unreasonably withheld, delayed or conditioned.

11.6 Counterparts. This Agreement may be executed by the Parties in one or more counterparts, each of which will be deemed an original but all of which together will constitute one and the same agreement. A signed copy of this Agreement delivered by facsimile, e-mail or other means of electronic transmission will be deemed to have the same legal effect as delivery of an original signed copy of this Agreement.

11.7 Notices.

Any notice or other communication pursuant to this Agreement must be in writing and will be deemed effectively given to the other Party on the earliest of the following: (a) three Business Days after such notice or other communication is sent by registered U.S. mail, return receipt requested; (b) one Business Day after delivery of such notice or other communication into the custody and control of a nationally or internationally recognized overnight courier service for next day delivery; and (c) the date of delivery if such notice or other communication is sent by e-mail during normal business hours of the recipient (and otherwise, the next Business Day); and (d) the date of delivery if such notice or other communication is delivered in person; or (e) the date such notice or other communication is received; in each case to the appropriate address below (or to such other address as a Party may designate by notice to the other Parties in accordance with this Section 11.7):

If to GHI:

Genomic Health, Inc.

c/o Exact Sciences Corporation

5505 Endeavour Lane

Madison, WI 53719

Attn: General Counsel

Email: [***]

With a Copy to:

Genomic Health, Inc.

c/o Exact Sciences Corporation

5505 Endeavour Lane

Madison, WI 53719

Attn: General Counsel

If to MDx:

MDxHealth Inc.

15279 Alton Parkway, Suite 100

Irvine, CA 92618

Attention: General Counsel

Email: [***]

With a Copy to:

Foley Hoag LLP

155 Seaport Boulevard

Boston, MA 02210

Attn: Jeffrey L. Quillen

Email: [***]

11.8 Governing Law.

This Agreement will be governed by the Laws of the State of Delaware without giving effect to any choice or conflict of law principles of any jurisdiction.

11.9 Construction.

The article and section headings in this Agreement are inserted for convenience only and are not intended to affect the interpretation of this Agreement. Unless the context requires otherwise, references herein (a) to any Article, Section or attachment means such Articles or Section of, or such attachment, attached to this Agreement, (b) to any Law means such Law as amended from time to time and including any successor provisions thereto and all rules and regulations promulgated thereunder and (c) to any agreement, instrument or other document means such agreement, instrument or other document as amended, restated, supplemented or otherwise modified from time to time in accordance therewith and, as applicable, herewith. For purposes of this Agreement, (i) the words “include”, “including” and “including” will be deemed to be followed by the words “without limitation,” (ii) the word “or” is disjunctive but not necessarily exclusive and (iii) the words “herein,” “hereof,” “hereby,” “hereto,” and “hereunder” refer to this Agreement as a whole. This Agreement will be construed as if drafted jointly by the Parties and no presumption or burden of proof will arise favoring or disfavoring any Party by virtue of the authorship of any provision in this Agreement. All accounting terms not specifically defined in this Agreement will be construed in accordance with GAAP. All words in this Agreement will be construed to be of such gender or number as the circumstances require. References in this Agreement to time periods in terms of a certain number of days mean calendar days unless expressly stated herein to be Business Days. If any time period for giving notice or taking action hereunder expires on a day which is not a Business Day, the time period will automatically be extended to the Business Day immediately following such day.

11.10 Severability.

Any provision of this Agreement that is determined by any court of competent jurisdiction to be invalid or unenforceable will not affect the validity or enforceability of any other provision hereof or the validity or unenforceability of such provision in any other agreement or in any other jurisdiction. Any provision of this Agreement held invalid or unenforceable only in part or degree will remain in full force and effect to the extent not held invalid or unenforceable.

11.11 Force Majeure.

Notwithstanding anything to the contrary contained in this Agreement, neither Party will be liable for any interruption, delay or failure to perform any obligation under this Agreement when such interruption, delay or failure was caused by (a) an act of God; (b) flood, fire, earthquake, pandemic, epidemic or explosion; (c) war, invasion, hostilities (whether war is declared or not), terrorist threats or acts, riot or other civil unrest; (d) obligation to comply with a Governmental Order or Law; (e) embargoes or blockades; (f) national or regional emergency; (g) strikes, labor shortages, stoppages or slowdowns, or other industrial disturbances; (h) telecommunication breakdowns, power outages or shortages, lack of warehouse or storage space, inadequate transportation services, or inability or delay in obtaining sufficient supplies of adequate or suitable materials; and (i) other similar events (“Force Majeure Event”). The affected Party shall notify the other Party of such Force Majeure Event within three (3) days after such occurrence by giving written notice to the other Party stating the nature of the event, its anticipated duration and any action being taken to avoid or minimize its effect. The suspension of performance shall be of no greater scope and no longer duration than is necessary and the affected Party will use commercially reasonable efforts to remedy the situation and remove the cause and effect of the Force Majeure Event.

11.12 No Partnership or Joint Venture; Independent Contractor. In providing the Services, GHI will act solely as an independent contractor and not as an agent of MDx, and GHI will retain and exercise the authority to control, oversee and direct the performance of the details and the means and manner of the Services. MDx will have the right (to the extent consistent with sound operating practices in the discretion of GHI) to direct GHI to conduct or not to conduct certain Services (consistent with GHI’s obligations and the terms and conditions contained herein), but the means and manner of the same will be in the exclusive control of GHI. This Agreement is not intended to and will not be construed as creating a joint venture, partnership, agency or other association within the meaning of the common law or under the laws of the jurisdiction in which either Party is incorporated, organized or conducting business.

11.13 Further Assurances. In connection with this Agreement and all transactions contemplated by this Agreement, each Party hereto agrees to execute and deliver such additional documents and instruments as may be reasonably required for a Party to provide or receive the Services hereunder and to perform such other additional acts as may be reasonably necessary or appropriate to effectuate, carry out, and perform all of the terms and provisions of this Agreement.

11.14 Time is of the Essence. Time is of the essence with respect to all time periods and dates set forth herein with respect to the performance of the Services (including Annex A) and the dispute procedures described herein.

11.15 Use of Name. The Parties will not use the name, insignia, logo, trademark, trade name, abbreviation, nickname, or other identifying terms or mark (collectively the “Name”) of the other Party, its Affiliates, employees or staff in any manner, except as required by Law, without the express written consent of the other Party.

[Signature Page Follows]

IN WITNESS WHEREOF, GHI and MDx have executed this Reference Laboratory Services Agreement as of the date first above written

GENOMIC HEALTH, INC.	MDxHEALTH, INC.
By:	By:
Name:	Name:
Title:	Title:

EXHIBIT A

SERVICES

[***]

EXHIBIT B

TEST FEE SCHEDULE; LABORATORY SUPPORT MANAGER FEE

Test Fee Schedule

In accordance with Sections 5.1(c) and 5.3 of this Agreement, the Parties have negotiated and established at arms-length this Test Fee Schedule to be in compliance with all applicable Laws and consistent with the Fair Market Value for the Test, based upon key market factors identified by the Parties and good faith projections by the Parties, including without limitation, (a) costs of performing the Test, and (b) the costs of delivering the Test to MDx for MDx delivery to MDx Customers (with assistance from GHI as needed solely for the Transition Services Period, to the extent consistent with the Transition Services Agreement), and such other contributions of the respective Parties as set forth in this Agreement. The Parties will continue in good faith to assess all of these factors and others in order to validate the assumptions, estimations and projections used to calculate Fair Market Value. The Parties agree to undertake future assessments and further verification to assure that the Test Fee Schedule is and remains consistent with Fair Market Value as further set forth below.

[***]

Exhibit H

Form of Employee Leasing Agreement

Execution Copy

EMPLOYEE LEASE AGREEMENT

This Employee Lease Agreement (this “Agreement”), dated as of August 2, 2022 (the “Effective Date”), is by and between MDxHealth, SA, a limited liability company (société anonyme) organized and existing under the laws of Belgium (“MDx”), MDxHealth, Inc., a Delaware corporation (“MDxU.S.”), and Genomic Health, Inc., a Delaware corporation (“GHI”). MDx, MDx U.S. and GHI are sometimes hereinafter referred to individually as a “Party” or collectively as the “Parties.” Capitalized terms used but not defined herein will have the meanings ascribed to such terms in the Purchase Agreement (as defined below).

RECITALS

WHEREAS, MDx and GHI are parties to that certain Asset Purchase Agreement of even date herewith (the “Purchase Agreement”), concerning the sale of certain assets of the business of GHI, providing for, among other things, (i) the sale, transfer and assignment to MDx of the Purchased Assets and (ii) MDx’s assumption of the Assumed Liabilities; and

WHEREAS, subject to Section 6.05(a) of the Purchase Agreement, to facilitate MDx’s continued operation of the Business following the Closing Date while allowing more time for the orderly transition of Leased Employees to MDx employment, MDx desires to lease from GHI, and GHI desires to lease to MDx, the services of the Leased Employees during the Leasing Period (as defined below) upon the terms set forth in this Agreement and in the Purchase Agreement.

WHEREAS, subject to Section 6.05(a) of the Purchase Agreement, MDx is obligated to offer employment to the Leased Employees, effective as of the Employment Commencement Date (as defined in Section 6.05 of the Purchase Agreement), in connection with the sale of the Business to MDx upon the terms set forth in this Agreement and in the Purchase Agreement.

NOW, THEREFORE, in consideration of the foregoing and the respective representations, warranties, covenants and agreements contained herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto agree as follows:

1. Additional Definitions.

“ADA” means the Americans with Disabilities Act of 1990.

“Agreement” has the meaning set forth in the preamble hereto.

“COBRA” means the continuation coverage requirements under Code Section 4980B and Part 6 of Title I of ERISA.

“Employment Commencement Date” has the meaning set forth in Section 6.05(a) to the Purchase Agreement.

“Federal Rehabilitation Act” means the Rehabilitation Act of 1973.

“Indemnified Actions” has the meaning set forth in Section 7.3.

“Leased Employee” has the meaning set forth in Section 6.05(a) to the Purchase Agreement.

“Leasing Period” has the meaning set forth in Section 6.05(a) to the Purchase Agreement.

“Payroll Costs” means with respect to the Leased Employees, GHI’s actual payroll costs and expenses in respect of services performed by the Leased Employees during the Leasing Period and employee benefit costs and expenses incurred by GHI with respect to the Leased Employees during the Leasing Period or for claims that relate to events that occur during the Leasing Period, including but not limited to salary, wages, incentive compensation, commissions, vacation and holiday pay; pay equity adjustments; sick pay or leave; workplace safety and insurance, or assessments; income and employment tax withholdings and contributions, including the employer’s share of such amounts; employer health costs, expenses, or premiums; contributions to, benefits accrued under, or claims paid under or in connection with any Employee Benefit Plans, employee benefit plans sponsored or maintained by GHI or its Affiliates (including but not limited to any plans covered by Section 3(3) of ERISA and other pension, retirement or profit sharing plans); costs of any perquisites provided to such employees; travel reimbursement; car allowances and company vehicle licensing or other vehicle-related expenses; and all taxes paid by GHI in respect of any of the foregoing, net of any contributions by Leased Employees towards the cost of employee benefits (to the extent reflected in the amounts above) and any insurance proceeds (e.g., stop-loss coverage) received by GHI with respect to claims made under Employee Benefit Plans that relate to events that occur during the Leasing Period.

“Payroll Date” means a calendar day during which GHI pays the Leased Employees.

“Purchase Agreement” has the meaning set forth in the recitals hereto.

“MDx” has the meaning set forth in the preamble hereto.

“MDx’s Contact” means the individual specified in Section 7.2 under the heading “For MDx”.

“Reconciliation” has the meaning set forth in Section 5.1.

“GHI” has the meaning set forth in the recitals hereto.

“GHI’s Contact” means the individual specified in Section 7.2 under the heading “For GHI”.

2. Leasing Arrangement. During the Leasing Period, GHI shall use reasonable efforts to continue to employ the Leased Employees and to make the Leased Employees exclusively available to MDx (without any requirement to provide any additional compensation or benefits to such Leased Employees that will not be reimbursed pursuant to this Agreement) to perform such lawful tasks as MDx may direct in its sole discretion in the operation of the Business, subject to applicable Law and the terms of all applicable GHI employment or collective bargaining policies or Contracts.

3. Leased Employees.

3.1. Status of Leased Employees. Subject to Section 6.05(a) of the Purchase Agreement, during the Leasing Period (a) all Leased Employees providing services to MDx under this Agreement shall remain at-will employees of GHI, (b) GHI shall with respect to the Leased Employees be responsible for maintaining payroll, compensating Leased Employees, fulfilling all payroll tax and benefit withholding, depositing and reporting obligations, and operating and administering all Employee Benefit Plans, and (c) GHI shall maintain all necessary personnel administration records for the Leased Employees. Subject to Section 6.05(c) of the Purchase Agreement, MDx shall maintain any required coverage under any statutory workers’ compensation scheme on the Leased Employees, sufficient to comply with all applicable Laws. MDx shall take all necessary steps to maintain GHI as an additional insured covered by any such workers’ compensation insurance policy and shall include an endorsement, and promptly provide a copy of such endorsement in writing to GHI, to any such workers’ compensation insurance policy that explicitly provides that MDx is obligated to maintain workers’ compensation and employer liability insurance on the Leased Employees, during the Leasing Period. Effective as of the expiration of the Leasing Period, GHI shall take such actions necessary to terminate the employment of all Leased Employees who are then employed by GHI as of immediately prior to the Employment Commencement Date and the Leased Employees shall be offered employment by MDx in accordance with the terms of the Purchase Agreement, effective as of the Employment Commencement Date.

3.2. Instruction of Leased Employees. MDx shall be solely responsible for directing the work of, and giving instructions to the Leased Employees regarding the provision of services during the Leasing Period. In furtherance of the foregoing: (a) MDx shall be responsible to manage the Leased Employees on a day to day basis consistent with the terms of this Agreement. MDx will be responsible to ensure the Leased Employees comply with all MDx policies, codes of conduct, and other requirements, and to implement or facilitate all required training required under MDx’s policies; (b) MDx’s instructions to the Leased Employees may include directions relating to the requisite means for executing the services under this Agreement, including but not limited to work schedule, organization and use of internal services, timing of meetings and so on; provided, however, that MDx’s authority to direct the Leased Employees shall be limited to the same extent that GHI’s authority would be limited by any applicable Law, Contract (including the applicable collective bargaining agreements), or policies of GHI; and (c) GHI shall not be responsible for, and shall not, give instructions to the Leased Employees regarding the work and provision of services under this Agreement.

3.3. Decisions Concerning Leased Employees. Subject to Section 6.05(a) of the Purchase Agreement, during the Leasing Period, MDx shall be entitled to make certain decisions concerning the Leased Employees, including but not limited to decisions related to the hiring, work incapacity, work schedules, and day-to-day work activities with respect to the Leased Employees; provided for the avoidance of doubt, MDx shall not be entitled to make any decision relating to compensation; promotion; demotion; written discipline, up to and including termination of employment; changes to working conditions; or cash remuneration, with respect to the Leased Employees. If MDx believes any such matters should be undertaken with respect to any of the Leased Employees, MDx shall present the proposed action(s) to GHI and GHI shall make its own determination whether to accept or reject MDx’s proposed action(s), in GHI’s reasonable discretion. MDx must accept GHI’s decision in all cases. If GHI agrees such action(s) are appropriate and consistent with all applicable Laws, all Employee Benefit Plans, GHI’s policies, and any GHI Contract, GHI shall take such actions with respect to the Leased Employees or authorize MDx to implement such changes as approved. During the Leasing Period, unless otherwise required by applicable Law, GHI agrees it will not change any compensation, benefits, other material terms and conditions of employment, policies or requirements applicable to the Leased Employees without MDx’s written consent and will obtain MDx’s agreement on the proposal and reimbursement of the costs before implementing any such changes. Notwithstanding the foregoing, in the event that any Leased Employee terminates his or her employment with GHI prior to the end of the Leasing Period, GHI shall have no obligation to provide the services of any replacement employee.

3.4. Worker’s Compensation. Subject to Section 6.05(c) of the Purchase Agreement and subject to Section 3.1 of this Agreement to the extent not provided or paid by MDx or MDx’s workers’ compensation coverage, during the Leasing Period, GHI shall with respect to the Leased Employees (a) pay, if and when due, the expense for all workers’ compensation benefits (including weekly benefits, medical and rehabilitation expenses, and any other expenses or obligations) payable on account of any injuries, illnesses or other conditions of the Leased Employees and/or maintain any required coverage under any statutory workers’ compensation scheme, provided that any expense covered under this Section 3.4 is fully reimbursable to GHI by MDx, and (b) complete all filing and all required claims and reports with respect to such workers’ compensation benefits.

3.5. Compliance with Laws. During the Leasing Period, MDx shall fully comply with all applicable Laws related to the Leased Employees under this Agreement, including all applicable Laws relating to a safe and accessible work environment. During the Leasing Period, GHI shall fully comply with all applicable Laws related to the employment of any Leased Employee.

3.6. Americans with Disabilities Act. During the Leasing Period, MDx shall make available any reasonable accommodation to any Leased Employee entitled to such an accommodation under the ADA, the Federal Rehabilitation Act or any comparable Law. MDx shall be responsible for the cost of providing any such reasonable accommodations to any Leased Employee. MDx shall promptly inform GHI’s Contact if any Leased Employee submits a request to MDx, and GHI shall promptly inform MDx’s Contact if any Leased Employee submits a request to GHI, for a reasonable accommodation under the ADA, the Federal Rehabilitation Act or comparable Law. GHI’s decision on whether such reasonable accommodation should be provided will control provided such accommodation does not unreasonably burden MDx’s ability to operate its facilities.

4. Payroll Leasing and Employment Reporting.

4.1. Payroll Leasing. Subject to Section 6.05(a) of the Purchase Agreement, during the Leasing Period, (a) the Leased Employees shall be paid through GHI’s payroll and (b) all Leased Employees’ payroll withholding elections (such as those related to income taxes, qualified retirement plans or group health and welfare plans) shall remain the same from the Effective Date through the end of the Leasing Period, except to the extent that a Leased Employee elects (in a manner permitted to employees and plan participants generally) to change any such election or any change is required by applicable Law or the terms of any applicable Contract (including the collective bargaining agreements). During the Leasing Period, the GHI shall be responsible for (i) paying and shall pay to or on behalf of each Leased Employee all wages, salaries, bonuses, severance, and other compensation earned, vested, due accrued for payment, or payable under the applicable plan, policy or program (collectively, “Compensation”), (ii) deducting all employment and other Taxes, withholdings and other legally required deductions (such as in the nature of social security payments or judicially ordered deductions), (iii) paying all Taxes on or with respect to such Compensation as may be required of an employer, (iv) maintaining, contributing to or paying (as applicable) unemployment insurance, unemployment compensation, disability, retirement contributions, and any other insurance and fringe benefits with respect to the Leased Employees, and (v) any reporting, disclosure and withholding obligations in connection therewith.

4.2. Employment Reporting. Subject to Section 6.05(a) of the Purchase Agreement, consistent with the Leased Employees being employees of GHI during the Leasing Period, GHI shall respond during the Leasing Period to all questions and inquiries from any Governmental Authority, Leased Employee, or any other Person regarding payroll and employment data and history relating to the Leased Employees for periods prior to the end of the Leasing Period. If MDx receives any such questions or inquiries directly, it shall refer such questions and inquiries to GHI. MDx is not authorized to make any responses or provide any information in response to those inquiries or questions.

4.3. Confidentiality/Employee Creations. Confidential, proprietary and trade secret information of MDx and its Affiliates learned by Leased Employees during the Leasing Period shall remain owned by MDx and its Affiliates and GHI will acquire no right to receive or access such information. As between GHI and MDx, any creations developed by Leased Employees during the Leasing Period shall be owned by MDx and its Affiliates, and GHI hereby assigns and agrees to assign to MDx and its Affiliates any rights therein inuring to GHI. GHI hereby assigns to MDx GHI’s rights (if any) with respect to the enforcement of confidentiality obligations and assignment of invention obligations of Leased Employees owed to GHI relating to the performance of services of the Leased Employees during the Leasing Period.

5. Payments.

5.1. Payment of Salaries/Wages. No later than 5:00 p.m. on the second Business Day after each Payroll Date, GHI shall deliver to MDx’s Contact a payroll statement that reflects the Payroll Costs for the Leased Employees for such payroll period. Within two (2) Business Days after receiving any such payroll statement from GHI, MDx U.S. shall pay to GHI, by wire transfer of immediately available funds, in accordance with wiring instructions to be provided to MDx’s Contact in writing from GHI, the amount of funds reflected in such payroll statement from GHI. Upon GHI’s request, MDx U.S. shall promptly provide to GHI’s Contact any information that is within MDx’s or MDx U.S.’s control and that is reasonably necessary for GHI to complete such payroll statements, including the number of daily and weekly hours worked by any Leased Employee who is compensated on an hourly basis, including overtime (which, for the avoidance of doubt, MDx shall be responsible for recording). Within thirty (30) days after the expiration of the Leasing Period, GHI shall deliver to MDx’s Contact a reconciliation of the aggregate Payroll Costs for the Leasing Period and the amounts paid by MDx U.S. to GHI under this Section 5.1 (the “Reconciliation”), subject to review and approval by MDx and MDx U.S., which approval shall not be unreasonably withheld, conditioned, or delayed. If the Reconciliation shows that the Payroll Costs have been overpaid by MDx U.S., then GHI shall pay to MDx U.S. the amount of the overpayment within ten (10) days after GHI delivers the Reconciliation to MDx’s Contact or, if later, within ten (10) days after the Reconciliation has been finally determined. If such Reconciliation shows that the Payroll Costs have been underpaid by MDx U.S., then MDx U.S. shall pay to GHI the amount of the underpayment within ten (10) days after GHI delivers the Reconciliation to MDx’s Contact or, if later, within ten (10) days after the Reconciliation has been finally determined.

5.2. Survival. The provisions of Section 5.1 shall survive any termination or expiration of this Agreement.

6. Employee Benefits.

6.1. Benefits Plans. Subject to Section 6.05(a) of the Purchase Agreement, during the Leasing Period, the Leased Employees shall continue to be eligible to participate in the Employee Benefit Plans of GHI during the Leasing Period (each in a manner permitted to employees and plan participants generally), subject to the terms and conditions of the applicable plans.

6.2. COBRA. Subject to Section 6.05(a) of the Purchase Agreement, during the Leasing Period, GHI shall be responsible for the COBRA administration of GHI’s group health plans in respect of the Leased Employees (and their qualified beneficiaries), including providing the appropriate COBRA notices and making available any coverage required under COBRA in respect of such individuals for any qualifying event (as defined in COBRA) that occurs before or during the Leasing Period.

6.3. Qualified Retirement Plans. Subject to Section 6.05(a) of the Purchase Agreement, during the Leasing Period, the Leased Employees shall continue to be eligible to participate in any of GHI’s qualified retirement plan(s), consistent with each such Leased Employee’s eligibility and election immediately prior to the Closing or any change in such election made during the Leasing Period (each in a manner permitted to employees and plan participants generally), subject to the terms and conditions of the applicable plans.

6.4. Vacation, Holidays, Sick Leave, and Other Leaves of Absence. Subject to Section 6.05(a) of the Purchase Agreement, during the Leasing Period, each Leased Employee’s vacation days, sick leave and all other leaves of absence shall be (or continue to be) administered in accordance with GHI’s policies and programs applicable to Leased Employees as of the Closing Date.

7. Relationship of the Parties.

7.1. Delivery of Information; Cooperation. MDx shall provide GHI, and GHI shall provide MDx, with such information and materials reasonably necessary to enable each party’s prompt and complete performance of its duties and obligations under this Agreement. The parties agree that they shall cooperate with each other and shall act in such a manner as to promote the prompt and efficient completion of the obligations hereunder.

7.2. Contacts and Notices. For purposes of this Agreement each party hereby appoints the person named below as its primary contact for any and all matters requiring notice under this Agreement and any notice to that party required or permitted by this Agreement shall be deemed given when delivered to the applicable person named below:

For GHI:

c/o Exact Sciences Corporation

5505 Endeavor Lane

Madison, WI 53719

Attn: [***], Deputy General Counsel

E-Mail: [***]

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

K&L Gates LLP

300 South Tryon Street, Suite 1000

Charlotte, NC 28202

Attn: John Blair

E-Mail: [***]

For MDx and MDx U.S.:

MDxHealth, Inc.

15279 Alton Parkway, Suite 100

Irvine, CA 92618

Attn: General Counsel

E-Mail: [***]

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

Foley Hoag LLP

155 Seaport Boulevard

Boston, MA 02210

Attention: Jeffrey L Quillen

E-Mail: [***]

7.3. Indemnification.

(a) Exclusive Remedies; Limitations; Survival. THE MDX INDEMNIFICATION PROVISIONS SET FORTH IN SECTIONS 8.03 AND 8.04 OF THE PURCHASE AGREEMENT WILL NOT APPLY TO AND WILL HAVE NO FORCE OR EFFECT RELATED TO MDX’S INDEMNIFICATION OBLIGATIONS TO GHI AS SET FORTH IN THIS SECTION 7.3, AND MDX AGREES GHI CAN RELY ON THIS SECTION 7.3 AS ITS INDEMNIFICATION REMEDY FOR ANY CLAIMS RELATED TO THE LEASED EMPLOYEES OR THIS AGREEMENT AS SET FORTH HEREIN. THE REMEDIES DESCRIBED IN THIS SECTION 7.3 ARE THE SOLE AND EXCLUSIVE REMEDIES OF THE PARTIES WITH RESPECT TO THE MATTERS SET FORTH IN THIS AGREEMENT. EXCEPT AS SET FORTH IN SUBSECTION (b) BELOW, IN NO EVENT WILL EITHER PARTY BE LIABLE TO THE OTHER PARTY UNDER OR IN CONNECTION WITH THIS AGREEMENT FOR ANY REMOTE, INDIRECT, SPECULATIVE, CONSEQUENTIAL, SPECIAL, INCIDENTAL, EXEMPLARY OR PUNITIVE LOSS OR DAMAGES (INCLUDING LOST PROFITS OR SALES) ARISING FROM OR RELATED TO THE SERVICES, EVEN IF ADVISED OF THEIR POSSIBLE EXISTENCE. THE ALLOCATIONS OF LIABILITY IN THIS SECTION REPRESENT THE AGREED AND BARGAINED-FOR UNDERSTANDING OF THE PARTIES WITH RESPECT TO THE ALLOCATION OF RISKS ARISING HEREUNDER. THE OBLIGATIONS OF THE PARTIES PURSUANT TO THIS SECTION 7.3 WILL SURVIVE THE END OF THE LEASING PERIOD AND EXPIRATION OR OTHER TERMINATION OF THIS AGREEMENT FOR A PERIOD OF THREE YEARS.

(b) MDx will indemnify and hold harmless all Seller Indemnitees from and against any and all claim, suit, proceeding, loss, liability, damage, cost (including court costs, costs of investigation, and reasonable legal fees and expenses), expense, judgment, settlement, interest, award, recovery or tax (“Loss”), including relating to the death of any person, any incidental, indirect, or consequential damages, any punitive, exemplary, or special damages, any fines, penalties, or assessments made by any Governmental Authority, any financial impact to GHI’s Business as a result of any Loss and all expenses, including all attorneys’ fees, costs, and other expenses which arise from, relate to, or which may be incurred by GHI or any other Seller Indemnitee in connection with this Agreement or the Leased Employees including, without limitation, directions given by MDx to any Leased Employee or the failure of MDx to effectively or properly manage or supervise any Leased Employee or his or her actions, or the performance of the services pursuant to this Agreement (the “Indemnified Actions”). For the avoidance of doubt Indemnified Actions include, without limitation, (i) any Action brought by or on behalf of any Leased Employee arising out of, relating to, or in connection with (A) any allegation that any Leased Employee was subjected to, during the Leasing Period, unlawful discrimination, harassment or retaliation in violation of any applicable federal, state, or local fair employment practices law, including, but not limited to, Title VII of the Civil Rights Act, the Americans with Disabilities Act (ADA), the Family Medical Leave Act (FMLA), the Fair Labor Standards Act (FLSA), the Equal Pay Act, the Employee Retirement Income Security Act (ERISA), the Civil Rights Act of 1991, Section 1981 of U.S.C. Title 42, the Fair Credit Reporting Act (FCRA), the Worker Adjustment and Retraining Notification (WARN) Act, the Tennessee WARN Act, the National Labor Relations Act (NLRA), the Age Discrimination in Employment Act (ADEA), the Uniform Services Employment and Reemployment Rights Act (USERRA), the Genetic Information Nondiscrimination Act (GINA), and the Immigration Reform and Control Act (IRCA) (B) any allegation that any Leased Employee was, during the Leasing Period, denied any leave benefit or accommodation to which such Leased Employee was entitled, worked in an unsafe work environment, or was not properly supervised, or (C) any other act or failure to act by MDx during the Leasing Period with respect to any Leased Employee, except to the extent that any such act or failure to act in clauses (A) – (C) is the result of the breach of this Agreement (including but not limited to any alleged noncompliance of applicable laws) by any Seller Indemnitees or is the result of conduct (including alleged conduct) by any Seller Indemnitees towards any Leased Employee; and (ii) notwithstanding anything in this Agreement to the contrary, any Action for any Losses or injunctive relief against any Seller Indemnitees which arises out of the MDx’s acts, errors, omissions or violations of applicable Law.

(i) In the event that any Seller Indemnitee is required to defend against any Action or prosecute any Action occasioned by the breach or default in any provision of this Agreement by MDx, or to enforce the terms of this Agreement, the Seller Indemnitee shall be entitled to reimbursement of all costs and expenses pertaining thereto, including reasonable attorneys’ fees and costs, in addition to any other relief to which the Seller Indemnitee may be entitled.

(ii) Expenses including reasonable attorneys’ fees incurred by any Seller Indemnitee in appearing at, participating in, or defending any Action shall be paid in full by the MDx in advance of the final disposition of such Action. The Seller Indemnitee shall deliver a written statement to the MDx requesting such advances from time to time and the MDxs shall remit such advances to MDx’s Contact.

(iii) In the event that any Indemnified Action is asserted by a third party, the Parties agree to cooperate and use commercially reasonable efforts to defend against such Indemnified Action and if an injunction or other order is issued in any such Indemnified Action, suit, or other proceeding, to use commercially reasonable efforts to have such injunction or other order lifted.

(c) The Indemnification Procedures set forth in Section 8.05 of the Purchase Agreement shall equally apply to indemnification claimed under this Section 7.3, and the terms of such Section 8.05 are fully incorporated herein by reference.

(d) The provisions of Section 7.3 shall survive any termination or expiration of this Agreement.

8. Term. This Agreement shall become effective on the Closing Date and shall terminate at 11:59 p.m. Eastern Time on the Employment Commencement Date. MDx shall use best efforts to implement all policies, procedures or plans and take all such other actions as are necessary to facilitate the transfer of the Leased Employees from GHI to MDx in accordance with Section 6.05(a) of the Purchase Agreement, as promptly as possible after the date hereof, and, in any event, prior to the Employment Commencement Date.

9. Default. If MDx materially or intentionally violates any terms and conditions of this Agreement, GHI will have the right to terminate this Agreement on five (5) days’ notice by providing a written notice to MDx outlining the default or breach by MDx and specifying the date this Agreement will terminate.

10. Miscellaneous.

10.1. Construction. The section headings in this Agreement are inserted for convenience only and are not intended to affect the interpretation of this Agreement. Unless the context requires otherwise, references herein (a) to any Section means such Section of this Agreement, (b) to any Law means such Law as amended from time to time and including any successor provisions thereto and all rules and regulations promulgated thereunder and (c) to any agreement, instrument or other document means such agreement, instrument or other document as amended, restated, supplemented or otherwise modified from time to time in accordance therewith and, as applicable, herewith. For purposes of this Agreement, (i) the words “include”, “including” and “including” will be deemed to be followed by the words “without limitation,” (ii) the word “or” is disjunctive but not necessarily exclusive and (d) the words “herein,” “hereof,” “hereby,” “hereto,” and “hereunder” refer to this Agreement as a whole. This Agreement will be construed as if drafted jointly by the Parties and no presumption or burden of proof will arise favoring or disfavoring any Party by virtue of the authorship of any provision in this Agreement. All accounting terms not specifically defined in this Agreement will be construed in accordance with GAAP. All words in this Agreement will be construed to be of such gender or number as the circumstances require. References in this Agreement to time periods in terms of a certain number of days mean calendar days unless expressly stated herein to be Business Days. If any time period for giving notice or taking action hereunder expires on a day which is not a Business Day, the time period will automatically be extended to the Business Day immediately following such day.

10.2. No Third-Party Beneficiaries. Except as expressly set forth in this Agreement, this Agreement does not confer any rights or remedies upon any person or entity other than the Parties and their respective successors and permitted assigns.

10.3. Purchase Agreement; No Set-off. Without limiting the effect of Section 7.3 herein, neither the making nor the acceptance of this Agreement will enlarge, restrict or otherwise modify the terms of the Purchase Agreement or constitute a waiver or release by any Party of any liabilities, obligations or commitments imposed upon them by the terms of the Purchase Agreement, including the representations, warranties, covenants, agreements and other provisions of the Purchase Agreement. Each Party, on behalf of itself and each of its Affiliates, agrees that (a) its rights and remedies under this Agreement will not give rise to any right of set-off, defense or counterclaim under the Purchase Agreement or any Ancillary Document (other than this Agreement) and (b) any rights and remedies that it or any of its Affiliates may have under the Purchase Agreement or any Ancillary Document (other than this Agreement) will not give rise to any right it may have to set-off, defense or counterclaim under this Agreement.

10.4. Amendments; No Waivers. No amendment, supplement or other modification of any provision of this Agreement will be valid unless it is in writing and signed by all of the Parties. No waiver of any provision of this Agreement will be valid unless the waiver is in writing and signed by the waiving Party. The failure of any Party at any time to require performance of any provision of this Agreement will not affect such Party’s rights at a later time to enforce such provision. No waiver by any Party of any breach of this Agreement will be deemed to extend to any other breach hereunder or affect in any way any rights arising by virtue of any other breach.

10.5. Successors and Assigns; Assignment. This Agreement will be binding upon and inure to the benefit of the Parties and their respective successors and permitted assigns. No Party may assign, delegate or otherwise transfer (whether by operation of Law, merger, consolidation, amalgamation, sale of assets or equity or otherwise and whether directly or indirectly) this Agreement or any of its rights, interests or obligations in this Agreement, in each case, without the prior written approval of the other Parties.

10.6. Entire Agreement. This Agreement constitutes the entire agreement among the Parties with respect to the subject matter hereof and supersedes all prior agreements (whether written or oral and whether express or implied) among any Parties with respect to the subject matter hereof. Except as specifically set forth herein, in the event and to the extent that there is a conflict between the provisions of this Agreement and the provisions of the Purchase Agreement as it relates to the Services hereunder, the provisions of the Purchase Agreement will control.

10.7. Parties in Interest. This Agreement will be binding upon and inure to the benefit of GHI and MDx and their respective successors and permitted assigns, and no other party will be conferred any rights by virtue of this Agreement or be entitled to enforce any of the provisions hereof. Nothing contained in this Agreement shall under any circumstances whatsoever be deemed or construed, or be interpreted, as making any third party a beneficiary of any term or provision of this Agreement or any instrument or document delivered pursuant hereto, and MDx and GHI expressly reject any such intent, construction or interpretation of this Agreement. Whenever a reference is made in this Agreement to GHI or MDx, such reference will include the successors and permitted assigns of such party under this Agreement.

10.8. Further Assurances. In connection with this Agreement and all transactions contemplated by this Agreement, each Party hereto agrees to execute and deliver such additional documents and instruments as may be reasonably required for a Party to provide or receive the Services hereunder and to perform such other additional acts as may be reasonably necessary or appropriate to effectuate, carry out, and perform all of the terms and provisions of this Agreement.

10.9. Time of Essence. Time is of the essence with respect to all time periods and dates set forth herein with respect to the performance of the services of the Leased Employees and the dispute procedures described herein.

10.10. Use of Name. The Parties will not use the name, insignia, logo, trademark, trade name, abbreviation, nickname, or other identifying terms or mark (collectively the “Name”) of the other Party, its Affiliates, employees or staff in any manner, except as required by Law, without the express written consent of the other Party.

10.11. Severability. Any provision of this Agreement that is determined by any court of competent jurisdiction to be invalid or unenforceable will not affect the validity or enforceability of any other provision hereof or the invalid or unenforceable provision in any other situation or in any other jurisdiction. Any provision of this Agreement held invalid or unenforceable only in part or degree will remain in full force and effect to the extent not held invalid or unenforceable.

10.12. Jurisdiction; Service of Process. ANY PROCEEDING ARISING OUT OF OR RELATING TO THIS AGREEMENT WILL BE BROUGHT AND DETERMINED EXCLUSIVELY IN THE DELAWARE COURT OF CHANCERY OF THE STATE OF DELAWARE; PROVIDED, THAT, IF THE DELAWARE COURT OF CHANCERY DOES NOT HAVE JURISDICTION, ANY SUCH PROCEEDING WILL BE BROUGHT EXCLUSIVELY IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE OR THE SUPERIOR COURT OF THE STATE OF DELAWARE (COMPLEX COMMERCIAL LITIGATION DIVISION) STATE. EACH PARTY (A) CONSENTS TO THE PERSONAL JURISDICTION OF SUCH COURTS (AND OF THE APPROPRIATE APPELLATE COURTS THEREFROM) IN ANY PROCEEDING ARISING OUT OF OR RELATING TO THIS AGREEMENT, (B) WAIVES ANY VENUE OR INCONVENIENT FORUM DEFENSE TO ANY PROCEEDING MAINTAINED IN SUCH COURTS, (C) EXPRESSLY WAIVES ALL RIGHT TO TRIAL BY JURY IN ANY ACTION OR PROCEEDING ARISING OUT OF OR RELATING TO THIS AGREEMENT, AND (D) EXCEPT AS OTHERWISE PROVIDED IN THIS AGREEMENT, PROCESS IN ANY SUCH PROCEEDING MAY BE SERVED ON ANY PARTY ANYWHERE IN THE WORLD.

10.13. Governing Law. This Agreement will be governed by the Laws of the State of Delaware without giving effect to any choice or conflict of law principles of any jurisdiction.

10.14. No Partnership or Joint Venture. This Agreement is not intended to and will not be construed as creating a joint venture, partnership, agency or other association within the meaning of the common law or under the laws of the jurisdiction in which any Party is incorporated, organized or conducting business.

10.15. Counterparts; Signatures. This Agreement may be executed by the Parties in one or more counterparts, each of which will be deemed an original but all of which together will constitute one and the same agreement. A signed copy of this Agreement delivered by facsimile, e-mail or other means of electronic transmission will be deemed to have the same legal effect as delivery of an original signed copy of this Agreement.

[Signature Page Follows]

IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed and delivered by their respective officers thereunto duly authorized, as applicable, as of the date first written above.

MDx:
MDxHealth SA
By:
Name:
Title:
MDx U.S.:
MDxHealth, Inc.
By:
Name:
Title:
GHI:
Genomic Health, Inc.
By:
Name:
Title:

***Signature Page to Employee Lease Agreement***

Exhibit I

Form of VA License Agreement

Execution Copy

Veterans Affairs Services License Agreement

This Veterans Affairs Services License Agreement (“VA License Agreement”), between MDxHealth SA, a limited liability company (société anonyme) organized and existing under the laws of Belgium (“MDx” or “Licensor”), Genomic Health, Inc., a Delaware corporation (“GHI”) and Exact Sciences Corporation, a Delaware corporation (“EXAS”, and together with GHI, each a “Licensee” and together the “Licensees”), is made as of August 2, 2022 (the “Effective Date”). GHI, EXAS and MDx are sometimes referred to herein individually as a “Party” and collectively as the “Parties.” Capitalized terms used but not defined herein will have the meanings ascribed to such terms in the Purchase Agreement (as defined below).

WHEREAS, GHI and MDx are parties to that certain Asset Purchase Agreement of even date herewith (the “Purchase Agreement”), pursuant to which MDx acquired certain business assets that are necessary for Licensees to perform the VA Services (as defined below);

WHEREAS, GHI and MDx are also parties to that certain (a) Transition Services Agreement of even date herewith (the “Transition Services Agreement”), and (b) Reference Laboratory Services Agreement of even date herewith (the “Reference Laboratory Services Agreement”), pursuant to which GHI agreed to perform, or cause its Affiliates to perform, certain services for MDx on a transitional basis following the Closing;

WHEREAS, GHI operates a duly licensed and accredited clinical testing laboratory (the “GHI Lab”); and

WHEREAS, Licensees desire to license certain intellectual property from MDx for a limited period following the Closing to enable Licensees, at the GHI Lab pursuant to the terms of this VA License Agreement, to continue to perform under unassignable contracts under which it is committed to provide the VA Services to the United States Department of Veterans Affairs (“VA”).

NOW, THEREFORE, in consideration of the mutual representations, warranties and agreements contained in this VA License Agreement, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:

1. Definitions. For purposes of this VA License Agreement, the following terms have the following meanings:

“Confidential Information” has the meaning set forth in Section 7.

“Effective Date” has the meaning set forth in the preamble.

“Indemnified Party” has the meaning set forth in Section 9.

“Indemnifying Party” has the meaning set forth in Section 9.

“Licensee” and “Licensees” have the meanings set forth in the preamble.

“Licensors” has the meaning set forth in the preamble.

“Term” has the meaning set forth in Section 11.1.

“Territory” means the United States of America.

“VA Services” means the services related to running the GPS Test pursuant to orders and awards to a Licensee from the VA for the performance of the GPS Test, including receiving samples from VA sites, processing such samples at the GHI Lab, and sending clinical results reports in respect of such processing to the applicable VA site.

2. License Grant. MDx hereby grants to Licensees and their Affiliates during the Term a non-exclusive, non-transferable, non-sublicensable license to use the Business Intellectual Property Assets in the Territory (excluding such assets as defined in clauses (d), (h) and (i) of the definition of Intellectual Property in the Purchase Agreement and clauses (i) and (ii) of the definition of Business Intellectual Property Assets in the Purchase Agreement) solely to provide the VA Services hereunder, including to make, use, copy, modify, distribute, display, offer to provide and provide the VA Services, and otherwise exploit such Business Intellectual Property Assets to provide the VA Services hereunder.

3. Reservation of Rights.

3.1 MDx reserves all rights not expressly granted to Licensees under this VA License Agreement. As between the parties, MDx owns any improvement, enhancement, or other modification of the Business Intellectual Property Assets made by or on behalf of any of the Parties (“Modification”). Modifications include, but are not limited to, copyrightable works of original authorship, ideas, inventions (whether patentable or not), “know how,” processes, compilations of information, trademarks and other intellectual property, but excludes all Confidential Information and Excluded Assets of GHI (after giving effect to the transactions consummated at the Closing). Licensees hereby assign to MDx all of its right, title, and interest in and to all Modifications, including all rights to apply for any patents or other intellectual property registrations with respect to such Modifications and all enforcement rights and remedies for past, present, and future infringement thereof and all rights to collect royalties and damages therefor. All intellectual property rights in any Modification, including patent, trademark or copyright applications and applications for registration filed by MDx, shall automatically be subject to the license granted in this Section. Before providing VA Services, Licensees’ employees, approved subcontractors and/or consultants engaged to perform the VA Services must have agreed in writing to (a) confidentiality and non-use obligations consistent with the terms of this VA License Agreement, and (b) assign or otherwise effectively vest in Licensees (as applicable) any and all rights that such personnel might otherwise have in the results of their work.

4. Payments.

4.1 Royalty; Payment. In consideration of the Business Intellectual Property Assets licensed hereunder, Licensees shall pay to Licensor, during the Term, a fair market value royalty payment at the rate of [***] per GPS Test performed by Licensees for the VA that utilizes the Business Intellectual Property Assets, regardless of whether Licensees receive reimbursement from the VA for a particular GPS Test. Within fifteen (15) Business Days of the end of the Term, GHI will remit to MDx the royalties due for the GPS Tests performed during the Term by the Licensees accompanied by a report setting forth in reasonable detail and with reasonable support the number of GPS Tests performed during the Term.

4.2 Taxes. Any sums payable under this VA License Agreement are exclusive of taxes and must be paid free and clear of all deductions and withholdings whatsoever, unless the deduction or withholding is required by Law.

4.3 Billing by Licensees. Licensees will be solely responsible for billing and collecting fees from the VA for all VA Services performed by Licensees hereunder. Licensees shall perform all billing and collection activities hereunder in accordance with (a) applicable Law; and (b) applicable contractual requirements with the VA.

4.4 Records. Licensees shall keep full, true and accurate books and records of its GPS Tests reasonably necessary and in compliance with privacy Laws for the calculation of payments to be made to MDx hereunder. However, Licensees have no (a) duty of trust or other fiduciary relationship with MDx regarding the maintenance of the records or the calculation and reporting of royalties; or (b) obligations to maintain any records except in accordance with its own document retention policy.

4.5 Audit.

(a) At the reasonable request, and sole expense, of Licensor within thirty (30) Business Days after receiving the royalty payment pursuant to Section 4.1 hereof, Licensees shall permit an independent certified public accountant designated by Licensor and reasonably acceptable to Licensees (the “Auditor”), to access Licensees’ records maintained pursuant to Section 4.4 upon not less than five (5) Business Days' prior written notice to Licensees and during Licensees’ normal business hours solely for the purpose of verifying the royalty payments remitted hereunder. The Auditor must conduct such audit in a manner designed to minimize disruption of Licensees’ normal business operations. All information and materials made available to or otherwise obtained or prepared by or for the Auditor in connection with such audit will be deemed Licensees’ Confidential Information and will be subject to the Auditor’s entry, prior to conducting the audit, into a written agreement with Licensees containing confidentiality and restricted use obligations at least as restrictive as those set out in Section 7 hereof. Notwithstanding the foregoing, Licensees shall not be required to provide access to or otherwise provide information in respect of Licensees’ records to the extent such information are protected by HIPAA. Licensor may not exercise this right more than once and the Auditor may only disclose to Licensor information limited to the accuracy of the report delivered to Licensor pursuant to Section 4.1 and any deficiency in the royalty payment made, or any overpayment. Licensor shall not compensate the Auditor (in whole or in part) contingent on the outcome of the audit.

(b) Licensor shall provide to Licensees a copy of the Auditor's audit report within two (2) Business Day of Licensor's receipt of the report. If the report shows that royalty payments made by Licensees are deficient, Licensees shall pay Licensor the deficient amount within five (5) Business Days after Licensees’ receipt of the audit report. If the report shows that payments made by Licensees are in excess of the required royalty payment, Licensor shall return any such excess amount to Licensees within five (5) Business Days after Licensor’s receipt of the audit report.

(c) The failure of Licensor to exercise its rights under Section 4.5(a) within thirty (30) Business Days after receiving the royalty payment pursuant to Section 4.1 shall be deemed acceptance by Licensor of the accuracy of the report and the royalty payment made by Licensees in accordance with Section 4.1 hereof.

5. Intellectual Property Prosecution and Enforcement.

5.1 Prosecution and Maintenance. MDx has the sole right, in its discretion and at its expense, to file, prosecute, maintain, and enforce the Business Intellectual Property Assets.

6. Compliance with Laws. The Parties shall comply fully with all applicable Laws in connection with performance of the VA Services.

7. Confidentiality.

7.1 Confidential Information. From time to time during the Term, the Parties or their Affiliates may disclose or make available (as the “Disclosing Party”) to another Party or its Affiliates (as the “Receiving Party”) information about the Disclosing Party’s (or the Disclosing Party’s Affiliates’) business or affairs, including information relating to the Business, clinical information, customers, clients, suppliers, vendors, investors, lenders, consultants, independent contractors or employees, price lists and pricing policies, financial statements and information, budgets and projections, business plans, production costs, market research, marketing, sales and distribution strategies, manufacturing techniques, processes and business methods, technical information, pending projects and proposals, new business plans and initiatives, research and development projects, inventions, discoveries, ideas, technologies, trade secrets, know-how, formulae, designs, patterns, marks, names, improvements, industrial designs, mask works, works of authorship and other Intellectual Property, devices, samples, plans, drawings and specifications, photographs and digital images, computer software and programming, the terms of this VA License Agreement, all other confidential information and materials relating to its business or affairs, and all notes, analyses, compilations, studies, summaries, reports, manuals, documents and other materials that ought reasonably to be considered confidential prepared by or for the Disclosing Party (or its Affiliates) containing or based in whole or in part on any of the foregoing, whether in verbal, written, graphic, electronic or any other form, whether or not conceived, developed or prepared in whole or in part by the Disclosing Party and whether or not marked as confidential (collectively, “ConfidentialInformation”). For clarity, the Parties acknowledge and agree that the Business Intellectual Property Assets and Modifications shall be the Confidential Information of MDx.

7.2 Exclusions. Confidential Information does not include information that, the Receiving Party can demonstrate with competent written records: (i) was publicly known at the time of disclosure, or has become publicly known through no breach of this VA License Agreement or the Ancillary Documents by Receiving Party or its Representatives; (ii) was rightfully obtained by the Receiving Party on a non-confidential basis from a third party that was in lawful possession of such information and not under any obligations of confidentiality regarding such information; or (iii) independently developed by the Receiving Party without reference to or use of any the Disclosing Party’s Confidential Information and that can be demonstrated by the Receiving Party through contemporaneous written records.

7.3 Protection of Confidential Information. The Receiving Party will safeguard the Confidential Information from unauthorized use, access, or disclosure using at least the degree of care it uses to protect its own confidential information and in no event less than a reasonable degree of care. The Receiving Party may use Confidential Information only for the purposes of fulfilling its obligations under this VA License Agreement and enforcing its rights under this VA License Agreement. The Receiving Party will not disclose the Disclosing Party’s Confidential Information to any Person or entity, except: (a) to the Receiving Party’s employees, Affiliates and subcontractors who have a need to know the Confidential Information for the sole purpose of fulfilling Receiving Party’s obligations under this VA License Agreement and who have been advised of the terms of this Section 7.3 and are bound by written obligations of confidentiality no less restrictive than the obligations of confidentiality herein, or (b) to the limited extent required in order to comply with the order of a court or other Governmental Authority, or as otherwise necessary to comply with applicable Law, provided that the Receiving Party will promptly provide the Disclosing Party with prior written notice so that the Disclosing Party may seek a protective order, provide reasonable assistance to the Disclosing Party in seeking such an order and will limit disclosure of such Confidential Information to only that portion of the Confidential Information which is required to be disclosed; provided that any Confidential Information so disclosed shall maintain its confidentiality protection for all purposes other than such legally compelled disclosure. Receiving Party will be liable for any breach of these confidentiality provisions by its Representatives.

7.4 Return or Destruction of Confidential Information. On the expiration or termination of this VA License Agreement or at the Disclosing Party’s written request, the Receiving Party will promptly return to the Disclosing Party all copies, whether in written, electronic, or other form or media, of the Disclosing Party’s Confidential Information, or at Disclosing Party’s written direction destroy all such copies and certify in writing to the Disclosing Party that such Confidential Information has been destroyed. Notwithstanding the foregoing, the Receiving Party may retain a copy of the Disclosing Party’s Confidential Information (a) to the extent and for so long as required by applicable Law, and (b) held electronically in archive or backup systems in accordance with general systems archiving and backup policies; on the condition that, in each instance, all such retained Confidential Information remains subject to the provisions of this Section.

7.5 Survival. The obligations imposed by this Section 7 will survive the termination or expiration of this VA License Agreement for five (5) years from the date of such termination or expiration; except with respect to Confidential Information that constitutes (i) trade secrets, which will survive the termination or expiration of this VA License Agreement for so long as the trade secret information is treated as trade secret under applicable Law or (ii) Business Intellectual Property Assets.

8. Representations.

8.1 Mutual Representations and Warranties. Each party represents and warrants to the other party that:

(a) it is duly organized, validly existing, and in good standing as a corporation or other entity as represented herein under the Laws of its jurisdiction of incorporation or organization;

(b) it has the full right, power and authority to enter into this VA License Agreement and to perform its obligations hereunder;

(c) the execution of this VA License Agreement by its representative whose signature is set forth at the end hereof has been duly authorized by all necessary corporate/organizational action of the party; and

(d) when executed and delivered by such party, this VA License Agreement will constitute the legal, valid, and binding obligation of such party, enforceable against such party in accordance with its terms.

9. Indemnification.

9.1 Indemnification by Licensees. Licensees shall defend, indemnify and hold MDx and its officers, directors, employees and agents harmless from and against any and all claims, suits, proceedings, damages, expenses (including court costs and reasonable attorneys’ fees and expenses), losses, liabilities, judgments, settlements, interest, awards, penalties, fines, costs and recoveries, of whatever kind (collectively, “Claims”), to the extent that such Claims arise out of, are based on, or result from (a)-(c) (inclusive) below, except in any case to the extent such Claim is caused by MDx’s or its Affiliates’, employees’ or agents’ negligence, willful misconduct or breach of this VA License Agreement:

(a) any breach of either Licensee’s representations, warranties, or obligations under this VA License Agreement;

(b) the willful misconduct, negligent acts, or violation of any Laws by Licensees, their Affiliates or the officers, directors, employees or agents of Licensees or their Affiliates under this VA License Agreement; and

9.2 Indemnification by MDx. MDx shall defend, indemnify and hold Licensees and their officers, directors, employees and agents harmless from and against any and all Claims, to the extent that such Claims arise out of, are based on, or result from (a) below, except in any case to the extent such Claim is caused by a Licensee’s or their Affiliates’, employees’ or agents’ negligence, willful misconduct or breach of this VA License Agreement:

(a) any breach of MDx’s representations, warranties, or obligations under this VA License Agreement

9.3 Indemnification Procedures. A Party claiming indemnity under this Section 9 (the “Indemnified Party”) shall give written notice to the Party from whom indemnity is being sought (the “Indemnifying Party”) promptly after learning of such Claim; provided that the failure to give such written notice shall not affect the right of the Indemnified Party to indemnity hereunder unless, and solely to the extent that, such failure has materially and adversely affected the rights of the Indemnifying Party. The Indemnified Party shall provide the Indemnifying Party with reasonable assistance, at the Indemnifying Party’s expense, in connection with the defense of the claim for which indemnity is being sought. The Indemnifying Party shall have the right to assume and conduct the defense of the claim with counsel of its choice; provided the Indemnified Party may participate in and monitor such defense with counsel of its own choosing, such counsel to be employed at the Indemnified Party’s sole cost and expense unless the interests of the Indemnified Party and the Indemnifying Party with respect to such Claim are sufficiently adverse to prohibit the representation by the same counsel of both Parties under applicable Law, ethical rules or equitable principles (in which case, the Indemnified Party shall control its defense, with the out-of-pocket costs and expenses including attorney’s fees with respect thereto borne by the Indemnifying Party); provided further, that the Indemnifying Party shall obtain the prior written consent (such consent to not be unreasonably withheld, delayed or conditioned) of any such Indemnified Party as to any settlement which would require an admission of legal wrongdoing in any way on the part of an Indemnified Party, or would otherwise materially adversely affect the Indemnified Party. So long as the Indemnifying Party is actively defending the claim in good faith, the Indemnified Party shall not settle or offer to settle any such claim without the prior written consent of the Indemnifying Party. If the Indemnifying Party does not assume and conduct the defense of the claim as provided above, (1) the Indemnified Party may defend against, and consent to the entry of any judgment or enter into any settlement with respect to the claim in any manner the Indemnified Party may deem reasonably appropriate (and the Indemnified Party need not consult with, or obtain any consent from, the Indemnifying Party in connection therewith), and (2) the Indemnifying Party will remain responsible to indemnify the Indemnified Party as provided in this Section 9.

9.4 Insurance. Licensee will maintain at its sole cost and expense, an adequate liability insurance or self-insurance program (including product liability insurance) to protect against potential liabilities and risk arising out of activities to be performed under this VA License Agreement and any agreement related hereto and upon such terms (including coverages, deductible limits and self-insured retentions) as are customary in the U.S. diagnostic testing industry for the activities to be conducted by Licensee under this VA License Agreement, and in all events appropriate for the foreseeable risks inherent in the provision of the VA Services as applicable. Upon request of Licensor, Licensee will provide proof of insurance or loss coverage required under the terms of this VA License Agreement. In addition, Licensee agrees to notify Licensor in writing in the event of material modification or change in such coverage.

10. Exclusive Remedies; Limitations; Survival. THE REMEDIES DESCRIBED IN THIS SECTION 10 AND SECTIONS 9.1 AND 9.2 ARE THE SOLE AND EXCLUSIVE REMEDIES OF THE PARTIES WITH RESPECT TO THE MATTERS SET FORTH IN SECTION 9.1 AND 9.2, AS APPLICABLE. IN NO EVENT WILL EITHER PARTY BE LIABLE TO THE OTHER PARTY UNDER OR IN CONNECTION WITH THIS VA LICENSE AGREEMENT FOR ANY REMOTE, INDIRECT, SPECULATIVE, CONSEQUENTIAL, SPECIAL, INCIDENTAL, EXEMPLARY OR PUNITIVE LOSS OR DAMAGES (INCLUDING LOST PROFITS OR SALES) ARISING FROM OR RELATED TO THE SERVICES, EVEN IF ADVISED OF THEIR POSSIBLE EXISTENCE. THE ALLOCATIONS OF LIABILITY IN THIS SECTION REPRESENT THE AGREED AND BARGAINED-FOR UNDERSTANDING OF THE PARTIES WITH RESPECT TO THE ALLOCATION OF RISKS ARISING HEREUNDER. NOTWITHSTANDING ANYTHING HEREIN TO THE CONTRARY, IN NO EVENT WILL ANY PARTY’S LIABILITY HEREUNDER EXCEED THE AMOUNTS ACTUALLY PAID BY LICENSEES TO MDX UNDER THIS VA LICENSE AGREEMENT. THE OBLIGATIONS OF THE PARTIES PURSUANT TO THIS SECTION 10 WILL SURVIVE THE END OF ANY END DATE AND EXPIRATION OR OTHER TERMINATION OF THIS VA LICENSE AGREEMENT.

11. Term.

11.1 Term. This VA License Agreement will commence as of the Effective Date and, will terminate as of the earliest of (a) December 31, 2022, (b) the date on which the GPS Test is added to the Federal Supply Schedule of MDx and GHI is accepted as a subcontractor for GPS Test under MDx’s Federal Supply Schedule, or (c) a date agreed upon in a writing signed by parties (the “Term”). Notwithstanding the foregoing or Section 12.1, the Term of this VA License Agreement shall automatically extend for the amount of time reasonably necessary for Licensees to complete the performance of any VA Services in process that could not otherwise reasonably be performed by MDx.

12. Post-Termination Rights and Obligations.

12.1 Effect of Termination. On the expiration or termination of this VA License Agreement for any reason and subject to any express provisions set out elsewhere in this VA License Agreement:

(a) all rights and licenses granted pursuant to this VA License Agreement cease;

(b) Licensees shall cease use of the Business Intellectual Property Assets with respect to the VA Services; and

(c) Licensees shall promptly return to Licensor or, at Licensor’s option, destroy, at Licensees’ expense, all records and copies of technical and promotional material in its possession relating to the VA Services, and of any Confidential Information of Licensor related to the VA Services; and all copies thereof.

12.2 Surviving Rights. The rights and obligations of the Parties set forth in this Section 12.2 and Section 1 (Definitions), **Error! Bookmark not defined.**4 (Payments), Section 87 (Confidentiality), Section 8 (Representations and Warranties), **Error! Bookmarknot defined.**9 (Indemnification), Section 12 (Post-Termination Rights and Obligation), and Section 14 (Miscellaneous), and any right, obligation, or required performance of the Parties in this VA License Agreement, which, by its express terms or nature and context is intended to survive termination or expiration of this VA License Agreement, will survive any such termination or expiration.

13. Assignment. The Parties shall not assign or otherwise transfer any of their rights, or delegate or otherwise transfer any of their obligations or performance, under this VA License Agreement, in each case whether voluntarily, involuntarily, by operation of law, or otherwise, without the other Party’s prior written consent, which shall not be unreasonably withheld, delayed or conditioned. For purposes of the preceding sentence, and without limiting its generality, any merger, consolidation, or reorganization involving either Party (regardless of whether the Party is a surviving or disappearing entity) will be deemed to be a transfer of rights, obligations, or performance under this VA License Agreement for which the other Party’s prior written consent is required. No delegation or other transfer will relieve either Party of any of its obligations or performance under this VA License Agreement. Any purported assignment, delegation, or transfer in violation of this Section 13 is void.

14. Miscellaneous.

14.1 Further Assurances. Each Party shall, upon the request of the other Party, promptly execute such documents and perform such acts as may be necessary to give full effect to the terms of this VA License Agreement.

14.2 Independent Contractors. The relationship between the Parties is that of independent contractors. Nothing contained in this VA License Agreement will be construed as creating any agency, partnership, joint venture, or other form of joint enterprise, employment, or fiduciary relationship between the Parties, and no Party has authority to contract for or bind any other Party in any manner whatsoever.

14.3 Notices. Any notice or other communication pursuant to this VA License Agreement must be in writing and will be deemed effectively given to the other Party on the earliest of the following: (a) three Business Days after such notice or other communication is sent by registered U.S. mail, return receipt requested; (b) one Business Day after delivery of such notice or other communication into the custody and control of a nationally or internationally recognized overnight courier service for next day delivery; and (c) the date of delivery if such notice or other communication is sent by e-mail during normal business hours of the recipient (and otherwise, the next Business Day); and (d) the date of delivery if such notice or other communication is delivered in person; or (e) the date such notice or other communication is received; in each case to the appropriate address below (or to such other address as a Party may designate by notice to the other Parties in accordance with this Section 14.3):

If to a Licensee:

Genomic Health, Inc.

c/o Exact Sciences Corporation

5505 Endeavour Lane

Madison, WI 53719

Attn: General Counsel

E-Mail: [***]

With a Copy to:

Alexis Crawford Douglas

K&L Gates LLP

70 W. Madison St, Suite 3300

Chicago, IL 60602

E-Mail: [***]

If to MDx:

MDxHealth Inc.

15279 Alton Parkway, Suite 100

Irvine, CA 92618

Attention: General Counsel

E-Mail: [***]

With a Copy to:

Foley Hoag LLP

155 Seaport Boulevard

Boston, MA 02210

Attn: Jeffrey L. Quillen

E-Mail: [***]

14.4 Purchase Agreement; No Set-off. Neither the making nor the acceptance of this VA License Agreement will enlarge, restrict or otherwise modify the terms of the Purchase Agreement or Transition Services Agreement, or constitute a waiver or release by any Party of any liabilities, obligations or commitments imposed upon them by the terms of the Purchase Agreement or Transition Services Agreement, including the representations, warranties, covenants, agreements and other provisions of the Purchase Agreement and the Transition Services Agreement. Each Party, on behalf of itself and each of its Affiliates, agrees that (a) its rights and remedies under this VA License Agreement will not give rise to any right of set off, defense or counterclaim under the Purchase Agreement or Transition Services Agreement and (b) any rights and remedies that it or any of its Affiliates may have under the Purchase Agreement or the Transition Services Agreement will not give rise to any right it may have to set off, defense or counterclaim under this Agreement.

14.5 Interpretation. For purposes of this VA License Agreement, (a) the words “include,” “includes,” and “including” will be deemed to be followed by the words “without limitation”; (b) the word “or” is not exclusive; and (c) the words “herein,” “hereof,” “hereby,” “hereto,” and “hereunder” refer to this VA License Agreement as a whole. Unless the context otherwise requires, references herein: (x) to Sections refer to the Sections of this VA License Agreement; (y) to an agreement, instrument, or other document means such agreement, instrument, or other document as amended, supplemented, and modified from time to time to the extent permitted by the provisions thereof; and (z) to a statute means such statute as amended from time to time and includes any successor legislation thereto and any regulations promulgated thereunder. This VA License Agreement will be construed without regard to any presumption or rule requiring construction or interpretation against the party drafting an instrument or causing any instrument to be drafted.

14.6 Headings. The headings in this VA License Agreement are for reference only and do not affect the interpretation of this VA License Agreement.

14.7 Entire Agreement. This VA License Agreement constitutes the entire agreement of the Parties to this VA License Agreement with respect to the subject matter contained herein, and supersedes all prior understandings and agreements (whether written or oral and whether express or implied) among any Parties with respect to the subject matter hereof. In the event and to the extent that there is a conflict between the provisions of this VA License Agreement and the provisions of any attachment hereto, the provisions of this VA License Agreement will control. Except as specifically set forth herein, in the event and to the extent that there is a conflict between the provisions of this VA License Agreement and the provisions of the Purchase Agreement, the provisions of the Purchase Agreement will control.

14.8 No Third-Party Beneficiaries. Except as expressly set for in Section 9 with respect to Indemnified Parties, this VA License Agreement is for the sole benefit of the Parties and their respective successors and assigns and nothing herein, express or implied, is intended to or will confer upon any other Person any legal or equitable right, benefit, or remedy of any nature whatsoever, under or by reason of this VA License Agreement.

14.9 Binding Agreement. Except as expressly set forth in this VA License Agreement, this VA License Agreement is binding upon and inures to the benefit of the Parties and their respective permitted successors and assigns.

14.10 Amendment and Modification; Waiver. No amendment, supplement or other modification of any provision of this VA License Agreement will be valid unless it is in writing and signed by all of the Parties. No waiver of any provision of this VA License Agreement will be valid unless the waiver is in writing and signed by the waiving Party. The failure of any Party at any time to require performance of any provision of this VA License Agreement will not affect such Party’s rights at a later time to enforce such provision. No waiver by any Party of any breach of this VA License Agreement will be deemed to extend to any other breach hereunder or affect in any way any rights arising by virtue of any other breach.

14.11 Severability. Any provision of this VA License Agreement that is determined by any court of competent jurisdiction to be invalid or unenforceable will not affect the validity or enforceability of any other provision hereof or the validity or unenforceability of such provision in any other agreement or in any other jurisdiction. Any provision of this VA License Agreement held invalid or unenforceable only in part or degree will remain in full force and effect to the extent not held invalid or unenforceable.

14.12 Governing Law; Submission to Jurisdiction. This VA License Agreement will be governed by the Laws of the State of Delaware without giving effect to any choice or conflict of law principles of any jurisdiction.

14.13 Equitable Relief. Licensees acknowledges that a breach by a Licensee of this VA License Agreement may cause Licensor irreparable harm, for which an award of damages would not be adequate compensation and agrees that, in the event of such a breach or threatened breach, Licensor will be entitled to equitable relief, including in the form of a restraining order, orders for preliminary or permanent injunction, specific performance, and any other relief that may be available from any court, and Licensees hereby waive any requirement for the securing or posting of any bond or the showing of actual monetary damages in connection with such relief. These remedies will not be deemed to be exclusive but are be in addition to all other remedies available under this VA License Agreement at Law or in equity, subject to any express exclusions or limitations in this VA License Agreement to the contrary.

14.14 Counterparts. This VA License Agreement may be executed by the Parties in one or more counterparts, each of which will be deemed an original but all of which together will constitute one and the same agreement. A signed copy of this VA License Agreement delivered by facsimile, e-mail or other means of electronic transmission will be deemed to have the same legal effect as delivery of an original signed copy of this VA License Agreement.

[Signature Page Follows]

IN WITNESS WHEREOF, the Parties have caused this VA License Agreement to be executed as of the Effective Date by their respective officers thereunto duly authorized.

LICENSOR	LICENSEE
MDXHEALTH	GENOMIC HEALTH, INC.
By:	By:
Name:	Name:
Title:	Title:
	EXACT SCIENCES CORPORATION
	By:
	Name:
	Title:

EXHIBIT J

Contribution Confirmation

To:	MDxHealth SA

Rue d’Abhooz 31

4040 Herstal

Belgium

From:	Genomic Health, Inc.

[Place/Date]

Asset Purchase Agreement – Conversion Notice

Dear Sirs,

The present letter (the “Contribution Confirmation”) is sent on behalf of Genomic Health, Inc., a Delaware corporation, with its principal place of business at 5505 Endeavour Lane, Madison, WI 53719.

Reference is made to the Asset Purchase Agreement, dated August 2, 2022 (the “Agreement”), between Genomic Health, Inc., as Seller, and MDxHealth SA, as Buyer. Capitalized terms used in this Contribution Confirmation but not otherwise defined herein shall have the meaning as ascribed to them in the Agreement.

The Seller hereby irrevocably confirms to the Buyer that:

1.	It shall contribute [the Closing ADS Payable, which is due<br>by Buyer for an amount of USD [amount of the Closing ADS Payable] to the share capital of the Buyer against the issuance by Buyer<br>of new Buyer Ordinary Shares, to be delivered to Seller in the form of [number of Buyer ADSs to be delivered as part of the ClosingEquity Consideration] Buyer ADSs, subject to and in accordance with the terms of Section [2.06] of the Agreement]/[an Earn-Out ADS<br>Payable, which is due by Buyer for an amount of USD [amount of the Earn-Out Consideration payable in the form of Buyer ADSs at theelection of the Buyer] to the share capital of Buyer against the issuance by Buyer of new Buyer Ordinary Shares, to be delivered<br>to Seller in the form of [relevant number of Buyer ADSs] Buyer ADSs, subject to and in accordance with the terms of Section [2.07]<br>of the Agreement];
2.	the relevant Buyer ADSs to be delivered to Seller shall need to be delivered to [delivery details /account details to be included];
---	---
3.	Seller understands and agrees that any Buyer ADSs, as well<br>as the underlying Buyer Ordinary Shares, issuable to Seller pursuant to the Agreement will be “restricted securities” under<br>applicable U.S. federal and state securities laws and that, pursuant to these laws, (i) Seller must hold the Buyer ADSs or, as the case<br>may be, Buyer Ordinary Shares indefinitely unless and until they are registered with the U.S. Securities and Exchange Commission and<br>qualified by state authorities under such laws, or an exemption from such registration and qualification requirements is available and<br>(ii) any certificates or book entries evidencing the Buyer ADSs or Buyer Ordinary Shares will bear restrictive legends to that effect.<br>Seller is acquiring the Buyer ADSs or, as the case may be, Buyer Ordinary Shares issuable to it pursuant to the Agreement for investment<br>for Seller’s own account, not as a nominee or agent, and not with a view to the resale or distribution of any part thereof. Seller<br>acknowledges that Buyer has no obligation to register or qualify Buyer Ordinary Shares or Buyer ADSs issued pursuant to the Agreement<br>for resale. Seller acknowledges that if an exemption from registration or qualification is available, it may be conditioned on various<br>requirements including, but not limited to, the time and manner of sale, the holding period for the Buyer Ordinary Shares and Buyer ADSs,<br>and on requirements relating to Buyer which are outside of Seller’s control, which Buyer is under no obligation and may not be<br>able to satisfy. Seller is an “accredited investor” as defined in Rule 501(a)(3) promulgated under the United States Securities<br>Act of 1933, as amended.
---	---
Yours faithfully,
---
On behalf of Genomic Health, Inc.
Name:

Exhibit 4.17

CERTAIN INFORMATION (INDICATED BY ASTERISKS) HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED.

Execution Copy

AMENDMENT TO ASSET PURCHASE AGREEMENT

This AMENDMENT TO ASSET PURCHASE AGREEMENT (this “Amendment”), dated as of January 1, 2023, is entered into between Genomic Health, Inc., a Delaware corporation (“GHI” or “Seller”), and MDxHealth SA, a limited liability company (société anonyme) organized and existing under the laws of Belgium (“MDx” or “Buyer”). Capitalized terms used but not defined herein shall have the respective meanings given to such terms in the Purchase Agreement (as defined below).

RECITALS

A. Seller and Buyer entered into an Asset Purchase Agreement (as amended, restated, supplemented or otherwise modified prior to the date hereof in accordance with the terms therein, the “Purchase Agreement”), dated as of August 2, 2022, pursuant to which, Seller sold and assigned to Buyer, and Buyer purchased and assumed from Seller, the Purchased Assets and the Assumed Liabilities related to the Business, subject to the terms and conditions set forth therein.

B. Pursuant to Section 6.20 of the Purchase Agreement, from and after the Closing Date, Seller was to continue performing the GPS Test pursuant to open orders and awards existing as of the Closing Date that were issued by the VA until the earlier of: (a) December 31, 2022, (b) the date on which the GPS Test was added to the Buyer’s Federal Supply Schedule and (to the extent required for Buyer to offer the GPS Test under the Federal Supply Schedule) GHI was accepted as a subcontractor for the GPS Test under MDx’s Federal Supply Schedule, or (c) a date agreed upon in a writing signed by parties.

C. Because of the [***], the Buyer and Seller desire to amend the Purchase Agreement in respect of the VA Arrangement.

D. Pursuant to Section 2.07 of the Purchase Agreement, Seller may be entitled to Earn-Out Consideration if the 2023 Business Revenue is equal to or greater than the 2023 Threshold.

E. Because of [***] prior to the commencement of the 2023 Earn-Out Period, and because revenue generated by the Buyer performing the GPS Test for the VA would otherwise contribute to the 2023 Business Revenue that determines whether the 2023 Threshold has been met and the amount, if any, of the 2023 Earn-Out Amount to which Seller may be entitled as Earn-Out Consideration, Buyer and Seller desire to amend the Purchase Agreement to reduce the 2023 Threshold in proportion to the 2023 Business Revenue that the Seller generates from performing the GPS Test for the VA.

F. Section 10.09 of the Purchase Agreement provides that the Purchase Agreement may only be amended, modified, or supplemented by an agreement in writing signed by Seller and Buyer, and Seller and Buyer desire to amend the terms of the Purchase Agreement as set forth herein by entering into this Amendment.

NOW, THEREFORE, in consideration of the mutual representations, warranties and agreements contained in this Amendment and the Purchase Agreement, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:

Amendment to Purchase Agreement.

(a) Definitions.

(i) The following definitions in Article I of the Purchase Agreement are hereby amended and restated in their entirety as follows:

“2023 Business Revenue” means the aggregate revenue recognized by Buyer and derived from the Business for the 2023 Earn-Out Period, calculated in accordance with the Accounting Principles; provided, however, that royalty payments received by Buyer pursuant to that VA License Agreement shall be excluded.

“2023 Threshold” means $[***]; provided, however, that the 2023 Threshold shall be reduced by the revenue recognized by GHI pursuant to the VA Arrangement between December 31, 2022 and the VA End Date.

“Ancillary Documents” means the Bills of Sale, the Assignment and Assumption Agreements, the Business Intellectual Property Assignments, the Transition Services Agreement, the Reference Laboratory Services Agreement, the VA License Agreement, the Clinical Research Study License Agreement, the Diagnostic Services Reseller License Agreement, the Trademark License Agreement, the Employee Leasing Agreement and any other agreements, instruments and documents delivered by the parties in connection with this Agreement or the transactions contemplated herein, as the same have been or may be amended, restated, modified or supplemented from time to time.

(ii) The following definitions are added to Article I of the Purchase Agreement:

“Clinical Research Study LicenseAgreement” means the Clinical Research Study License Agreement between GHI and MDx dated as of December 13, 2022.

“Diagnostic Services Reseller LicenseAgreement” means Diagnostic Services Reseller License Agreement between GHI and MDx dated as of December 8, 2022.

“MDx-Transitioned VA Site” means those VA Sites that have entered into a direct purchase authorization (BPAs), purchase order, or other invoicing arrangement with Buyer (itself or through its Affiliates) to order the GPS Test.

“VA End Date” means the earlier of (a) the date on which the GPS Test has been removed from GHI’s Federal Supply Schedule, (b) May 1, 2023, and (c) a date agreed upon in a writing signed by parties.

“VA Sites” means healthcare systems, medical centers, hospitals, clinics, and other healthcare facilities affiliated with the United States Department of Veterans Affairs for whom Seller performed the GPS Test.

(b) Section 2.07(a)(i) of the Purchase Agreement. Section 2.07(a)(i) of the Purchase Agreement is hereby amended and restated in its entirety as follows:

(i) To the extent that 2023 Business Revenue is equal to or greater than the 2023 Threshold, Seller shall be entitled to consideration equal to [***] ([***]%) of the actual 2023 Business Revenue, up to a maximum earn-out amount of $30,000,000 (the amount actually earned, the “2023 Earn-Out Amount”). If the 2023 Business Revenue is less than the 2023 Threshold, the 2023 Earn-Out Amount shall be $0.

(c) Section 6.20 of the Purchase Agreement. Section 6.20 of the Purchase Agreement is hereby amended and restated in its entirety as follows:

Section 6.20 VA Arrangement. From and after the Closing Date until the VA End Date, GHI shall continue to perform the GPS Test pursuant to open orders and awards existing as of the Closing Date that were issued by VA Sites for the performance of the GPS Test, in substantially the same manner as GHI has performed such services for such VA Sites immediately prior to the Closing Date (the “VA Arrangement”). At any time on or after March 16, 2023, GHI may, in its sole discretion, submit the necessary documentation to the VA for the removal of the GPS Test from its Federal Supply Schedule. GHI shall, within two (2) Business Days of receiving confirmation from the VA that the GPS Test has successfully been removed from GHI’s Federal Supply Schedule, notify MDx in writing of the same. Subject to the VA License Agreement, GHI shall be entitled to all revenue generated in respect of the VA Arrangement to the extent such revenue is generated from GPS Test results reported to a VA Site prior to it transitioning to an MDx-Transitioned VA Site. Buyer and Seller shall cooperate and work together in good faith to mutually determine the appropriate timing for the transition of VA Sites. Once a VA Site becomes a MDx-Transitioned VA Site, MDx will be responsible for communicating to Quadax that a VA Site has become a MDx-Transitioned VA Site and MDx is therefore responsible for billing the MDx-Transitioned VA Site and responsibility for billing cannot be changed back to GHI. In addition to any other requirements contained herein or in the VA License Agreement, MDx must (a) complete the agreed upon fields within the ‘VA Data Entry Template’ spreadsheet provided by Quadax for all GHI-related VA orders on a weekly basis, and (b) provide a copy of the completed TRF form to GHI for any GHI-related VA orders.

Notwithstanding anything that may be expressed or implied in this Agreement, each of the parties agrees and acknowledges that no recourse under this Agreement or any documents or instruments delivered in connection with this Agreement shall be had against GHI or its Affiliates for GHI removing the GPS Test from GHI’s (or its Affiliates’, as applicable) Federal Supply Schedule on or after March 16, 2023.

Effect of Amendment. This Amendment shall form a part of the Purchase Agreement for all purposes, and each party thereto and hereto shall be bound hereby. From and after the execution of this Amendment by the parties hereto, each reference in the Purchase Agreement to “this Agreement,” “hereof,” “hereunder,” “herein,” “hereby” or words of like import referring to the Purchase Agreement shall mean and be a reference to the Purchase Agreement as amended by this Amendment.

3. Full Force and Effect. Except as expressly amended hereby, each term, provision, exhibit and schedule of the Purchase Agreement is hereby ratified and confirmed and remains in full force and effect. This Amendment may not be amended except by an instrument in writing signed by the parties hereto. Except as expressly set forth herein, the execution, delivery and effectiveness of this Amendment shall not operate as a waiver of any right, power or remedy of the parties to the Purchase Agreement, nor constitute a waiver of any provision of the Purchase Agreement (or an agreement to agree to any future amendment, waiver or consent).

4. Counterparts; Electronic Delivery. This Amendment may be executed in counterparts, each of which shall be deemed an original, but all of which together shall be deemed to be one and the same agreement. A signed copy of this Agreement delivered by facsimile, e-mail or other means of electronic transmission shall be deemed to have the same legal effect as delivery of an original signed copy of this Amendment.

5. Additional Miscellaneous Terms. The provisions of Article X (Miscellaneous) of the Purchase Agreement shall apply mutatismutandis to this Amendment, and to the Purchase Agreement as modified by this Amendment, taken together as a single agreement, reflecting the terms as modified hereby.

[Signature page follows]

IN WITNESS WHEREOF, the parties hereto have caused this Amendment to be executed as of the date first written above by their respective officers thereunto duly authorized.

GENOMIC HEALTH, INC.
By	/s/ Brian Baranick
Name:	Brian Baranick
Title:	Authorized Signatory
MDXHEALTH SA
By	/s/ Michael K. McGarrity
Name:	Michael K. McGarrity
Title:	Chief Executive Officer and authorized signatory

[Signature Page to Amendmentto Purchase Agreement]

Exhibit 12.1

Certification by the Principal Executive Officerpursuant to

Securities Exchange Act Rules 13a-14(a) and15d-14(a)

as adopted pursuant to Section 302 of the Sarbanes-OxleyAct of 2002

I, Michael K. McGarrity, certify that:

1.	I have reviewed this annual report on Form 20-F of MDxHealth SA;
2.	Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
---	---
3.	Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the company as of, and for, the periods presented in this report;
---	---
4.	The company’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and have:
---	---
(a)	Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the company, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
---	---
(b)	Evaluated the effectiveness of the company’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
---	---
(c)	Disclosed in this report any change in the company’s internal control over financial reporting that occurred during the period covered by the annual report that has materially affected, or is reasonably likely to materially affect, the company’s internal control over financial reporting; and
---	---
5.	The company’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the company’s auditors and the audit committee of the company’s board of directors (or persons performing the equivalent functions):
---	---
(a)	All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the company’s ability to record, process, summarize and report financial information; and
---	---
(b)	Any fraud, whether or not material, that involves management or other employees who have a significant role in the company’s internal control over financial reporting.
---	---
Date: April 25, 2023
---	---
/s/ Michael K. McGarrity
Name:	Michael K. McGarrity
Title:	Chief Executive Officer and Executive Director
	(Principal Executive Officer)

Exhibit 12.2

Certification by the Principal Financial Officerpursuant to

Securities Exchange Act Rules 13a-14(a) and15d-14(a)

as adopted pursuant to Section 302 of the Sarbanes-OxleyAct of 2002

I, Ron Kalfus, certify that:

1.	I have reviewed this annual report on Form 20-F of MDxHealth SA;
2.	Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
---	---
3.	Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the company as of, and for, the periods presented in this report;
---	---
4.	The company’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and have:
---	---
(a)	Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the company, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
---	---
(b)	Evaluated the effectiveness of the company’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
---	---
(c)	Disclosed in this report any change in the company’s internal control over financial reporting that occurred during the period covered by the annual report that has materially affected, or is reasonably likely to materially affect, the company’s internal control over financial reporting; and
---	---
5.	The company’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the company’s auditors and the audit committee of the company’s board of directors (or persons performing the equivalent functions):
---	---
(a)	All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the company’s ability to record, process, summarize and report financial information; and
---	---
(b)	Any fraud, whether or not material, that involves management or other employees who have a significant role in the company’s internal control over financial reporting.
---	---
Date: April 25, 2023
---	---
/s/ Ron Kalfus
Name:	Ron Kalfus
Title:	Chief Financial Officer
	(Principal Financial Officer)

Exhibit 13.1

CERTIFICATION

PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTEDPURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Annual Report on Form 20-F of MDxHealth SA (the “Company”) for the year ended December 31, 2022 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Michael K. McGarrity, Chief Executive Officer and Executive Director of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, to my knowledge that:

1.	The Report fully complies with the requirements of Section<br>13(a) or 15(d) of the Securities Exchange Act of 1934; and
2.	The information contained in the Report fairly presents,<br>in all material respects, the financial condition and results of operations of the Company.
---	---
Date: April 25, 2023
---	---	---
	/s/ Michael K. McGarrity
	Name:	Michael K. McGarrity
	Title:	Chief Executive Officer and Executive Director
		(Principal Executive Officer)

Exhibit 13.2

CERTIFICATION

PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTEDPURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Annual Report on Form 20-F of MDxHealth SA (the “Company”) for the year ended December 31, 2022 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Ron Kalfus, Chief Financial Officer, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, to my knowledge that:

1.	The Report fully complies with the requirements of Section<br>13(a) or 15(d) of the Securities Exchange Act of 1934; and
2.	The information contained in the Report fairly presents,<br>in all material respects, the financial condition and results of operations of the Company.
---	---
Date: April 25, 2023
---	---	---
	/s/ Ron Kalfus
	Name:	Ron Kalfus
	Title:	Chief Financial Officer
		(Principal Financial Officer)

Exhibit 15.1

CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

MDxHealth SA

Herstal, Belgium

We consent to the reference to our firm under the caption “Experts” and to the use of our report dated April 25, 2023 included in this Form 20-F in the Registration Statement (Form F-3, File No. 333-268885).

BDO Réviseurs d’Entreprises SRL

On behalf of it,

/s/ Bert Kegels

Zaventem, Belgium

April 25, 2023