Exhibit 5.1
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Baker McKenzie BV/SRL
Bolwerklaan 21 Avenue du Boulevard - box 1
Tel: +32 2 639 36 11 Fax: +32 2 639 36 99 www.bakermckenzie.com |
13 August 2026
MDxHealth SA
CAP Business Center
Zone Industrielle des Hauts-Sarts
Rue d’Abhooz 31
4040 Herstal
Belgium
Dear all,
| RE: | MDXHEALTH SA – ISSUANCE OF SHARES |
| 1. | Introduction |
| (a) | We have acted as external Belgian legal advisers to MDxHealth SA of CAP Business Center, Zone Industrielle des Hauts-Sarts, Rue d’Abhooz 31, 4040 Herstal, Belgium, registered under company number 0479.292.440 RLP Liège (division Liège) (the “Company”), on certain Belgian law matters in connection with the Company’s Registration Statement (as defined below) filed with the United States Securities and Exchange Commission (the “SEC”) under the United States Securities Act of 1933, as amended (the “Securities Act”), in respect of the Company’s placement of new ordinary shares without nominal value of the Company (the “New Shares”) with certain Investors (as defined below), with admission to trading and listing of the New Shares on the Nasdaq Capital Market, covered by the Registration Statement to which this opinion is an exhibit (the “Issuance”). |
Partners Roel MEERS1,9* Luc MEEUS1,5,9* Kurt HAEGEMAN1,9* Dominique MAES1,9* Michael VAN ACKER1,9* Géry BOMBEKE1,9* Geert BOVY1,9* Gavin BUSHELL1,4,9* Gregory LEBRUN1,9* Dimitri VAN UYTVANCK1,9* Davinia MARTENS1,9 Julie PERMEKE1 Joren JANSSEUNE1,9 Arne NAERT1,9 David HAVERBEKE1,9 Wouter VANDORPE1,9 |
Bram HOORELBEKE1,9 Benjamin PIRLET1,9
Senior Counsels & Counsels Jozef SLOOTMANS1,9 Alain HUYGHE1,9 Jean-François VANDENBERGHE1, Mario DEKETELAERE2 Stéphane MARTIN9 Olivier VAN BAELEN1,9 Els JANSSENS1,9 Kim STAS1,9 Veerle LERUT1 Jérôme DE RUYVER1,9 Sebastian TYTGAT1,9 Nastassja WALSCHOT1,9 William-James KETTLEWELL1,9 Ellen DEVLOO1,9
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Pieter-Jan DENYS1,9 Kristoff COX1,9 Lisa WEINERT7,9 Nicolas CELIS1,9 Olivier VAN DEN BROEKE2,9
Associates Ellen HERINCKX1 Laura DECLERCQ1 Amaranta RUTZ1 Younes SEBBARH1,9 Eva CLAEYS1 Stéphanie DE POTTER1 Anne-Sophie CORNE1,9 Inès SILVESTRINI1,9 Clémence ROUMA1
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Eline KEGELS1 Stephanie VAN LAETHEM1 Anne-Marie GÜLGER1 Caroline MOUCHET1 Dieter GEUENS1 Tim MEYNEN1 Guillian BACLIN1 Alexandra STOICA2,9 Louis CORNET1 Auriane MARECHAL1 Diede
JACOBS1 Alexander BOSTOEN1
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Associated with the Brussels Bar E-List Victor SAINT-CAST7
B-List Tom JENKINS4,8,9 Roma MCCOOL4
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1 – Advocaat / Avocat, Member of the Brussels Bar | 2 – Advocaat, Member of the Antwerp Bar | 3 – Barrister, Inn of Court, Northern Ireland | 4 – Solicitor (England and Wales) | 5 – Attorney, Member of the New York Bar | 6 – Rechtsanwalt, Member of the Düsseldorf Bar | 7 – Avocat, Member of the Lille Bar | 8 – Solicitor of the High Court of Hong Kong | 9 – BV/SRL | * – Shareholder/Director of Baker McKenzie BV/SRL
Baker McKenzie BV/SRL. Vennootschap van advocaten/Société d’avocats. BTW/TVA: BE 0426.100.511 RPR Brussel/RPM Bruxelles.
| (b) | For the purposes of this opinion letter (the “Opinion Letter”): |
| (i) | we have reviewed only the documents referred to in paragraph 3 (Documents Reviewed); and |
| (ii) | we have completed only the searches and enquiries referred to in paragraph 4 (Searches and Enquiries); |
and we have not examined any other documents relating to or affecting, and have not made any other searches or enquiries concerning, any party to the Agreement (as defined below).
| (c) | Nothing in this Opinion Letter should be construed as implying that we are familiar with, or have made independent review or investigation of factual matters such as, the affairs of any of the parties to the Agreement, and this Opinion Letter is based solely on the investigations and subject to the limits stated in this Opinion Letter. We do not assume any responsibility for advising you of the (subsequent) discovery of information not previously known to us with respect to any matters described in this Opinion Letter. |
| (d) | The opinion in this Opinion Letter is limited to the matters stated herein and does not extend to, and is not to be read as extending by implication to, any other matter in connection with the Issuance, the Agreement, the transactions to which the Agreement relates, or otherwise. |
| 2. | Belgian Law Opinion |
| (a) | This Opinion Letter is limited to matters of Belgian law as in force, and as construed in published Belgian case law, as at the date of this Opinion Letter. Consequently: |
| (i) | we have made no investigation of foreign law, and do not express or imply any opinion on foreign law (including, but not limited to, the laws of the United States of America) or on European Union law as it affects any jurisdiction other than Belgium; |
| (ii) | we do not assume any responsibility for advising you of any changes in law or otherwise after the date of this Opinion Letter with respect to any matters described in this Opinion Letter; and |
| (iii) | we express no opinion on matters of taxation, matters of antitrust and competition, matters of fact or matters of accounting. |
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| (b) | As Belgian law counsel we are not qualified or able to assess the true meaning and purport of the terms or any agreements, documents and legal acts (rechtshandelingen / actes juridiques) subject or expressed to be subject to any applicable law other than Belgian law, including, but not limited to, the Registration Statement, the Prospectus Supplement (as defined below) and the Agreement (and the obligations of the parties thereto), and we have made no investigation of such meaning and purport. Our review of agreements, documents or legal acts (rechtshandelingen / actes juridiques) subject or expressed to be subject to any law other than Belgian law, including, but not limited to, the Registration Statement, the Prospectus Supplement and the Agreement, has therefore been limited to the terms of such documents as they appear to us on their face. |
| (c) | We do not admit we are “experts” within the meaning of the Securities Act, or the rules and regulations of the SEC promulgated thereunder, with respect to any part of the Registration Statement, the Prospectus Supplement or otherwise. |
| 3. | Documents Reviewed |
For the purposes of this Opinion Letter we have examined the following documents:
| (a) | an electronic version of a signed copy of the securities purchase agreement (the “Agreement”) relating to the Issuance, entered into on 11 August 2026, between the Company and several private parties named therein as “Purchasers” (collectively, the “Investors”, and each an “Investor”); |
| (b) | an electronic version of a copy of the Company’s registration statement on Form F-3 (File No. 333-292463), as filed with the SEC on December 29, 2025 (the registration statement at the time it became effective, including all information deemed to be a part thereof, including the amendments, exhibits and schedules thereto, at the time such registration statement became effective, is herein referred to as the “Registration Statement”; |
| (c) | an electronic copy of the Company’s prospectus supplement reflecting the final terms of the Issuance, as filed by the Company with the SEC on 13 August 2026, pursuant to Rule 424(b)under the U.S. Securities Act of 1933, as amended from time to time, and supplementing the base prospectus included in the Registration Statement (the “Prospectus Supplement”); |
| (d) | an electronic version of a copy of the amended and restated articles of association of the Company as filed in the legal entity file (dossier van de rechtspersoon/dossier de la personne morale) on 26 June 2026, electronically certified by the Royal Federation of Belgian Notaries (Koninklijke Federatie van het Belgisch Notariaat/Fédération Royale du Notariat Belge) on 12 August 2026 (as available through the Fednot Database (as defined below)); |
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| (e) | an electronic version of a signed copy of: |
| (i) | the minutes of the meeting of the board of directors of the Company held on 13 August 2026, authorising, approving, confirming and ratifying, as relevant, amongst other things, (A) the then current draft of the Prospectus Supplement and certain other materials in relation to the Issuance, (B) the then current draft of the report of the board of directors in accordance with article 7:198 juncto articles 7:179, 7:191 and 7:193 of the Belgian Companies and Associations Code, dated March 23, 2019, as amended from time to time (the “Belgian Companies and Associations Code”), and (C) the Agreement, the transactions contemplated therein, and certain other arrangements to which the Company is to be a party in relation to the Issuance; |
| (ii) | the minutes of the meeting of the board of directors of the Company held before notary public on 13 August 2026, authorising, approving, confirming and ratifying, as relevant, amongst other things, (A) the issuance of New Shares within the framework of the Issuance, and the dis-application of the statutory preferential subscription right of the Company’s existing shareholders and, as far as needed, of the Company’s existing holders of subscription rights of the Company for the benefit of the Investors, within the framework of the Company’s authorised capital in accordance with article 7:198 juncto articles 7:179, 7:191 and 7:193 of the Belgian Companies and Associations Code, (B) the Agreement and the transactions contemplated therein in relation to the Issuance, and (C) the effective realisation of the issuance of the New Shares; |
| (f) | an electronic version of a signed copy of the report of the board of directors of the Company in accordance with article 7:198 juncto articles 7:179, 7:191 and 7:193 of the Belgian Companies and Associations Code, approved by the meeting of the board of directors referred to in paragraph 3(e)(i); |
| (g) | an electronic version of a signed copy of the report of the statutory auditor of the Company prepared in accordance with article 7:198 juncto articles 7:179, 7:191 and 7:193 of the Belgian Companies and Associations Code in relation to the report of the board of directors referred to in paragraph 3(f); and |
| (h) | an electronic version of a signed copy of the certificate issued by KBC Bank NV on 13 August 2026 in accordance with article 7:198 juncto article 7:195 of the Belgian Companies and Associations Code certifying that USD 19,999,999.35 was available on a blocked account in the name of the Company. |
| 4. | Searches and Enquiries |
We have carried out the following searches and enquiries using the registration number of the Company with the Crossroads Bank for Enterprises as it appears in this Opinion Letter:
| (a) | we obtained a “full extract of the details of a registered entity (legal person)” issued by the Crossroads Bank of Enterprises in relation to the Company and referring to the circumstances in existence on 13 August 2026 (the “CBE Excerpt”); |
| (b) | on 13 August 2026, we carried out an on-line search in the Central Insolvency Register available on www.regsol.be (the “Regsol Search”) in relation to the Company which did not show any bankruptcy, public judicial reorganisation or transfer under judicial authority files opened in respect of the Company; |
| (c) | on 12 August 2026, we carried out an on-line search and review of the Annexes to the Belgian Official Gazette relating to the Company which shows any notices published up to 12 August 2026 (the “Publications”); and |
| (d) | on 12 August 2026, we conducted an online search in the database of articles of association maintained by the Royal Federation of Belgian Notaries (Koninklijke Federatie van het Belgisch Notariaat/Fédération Royale du Notariat Belge) available on https://statuten.notaris.be/costa_v1/enterprises/search (the “Fednot Database”) in relation to the Company. |
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| 5. | Assumptions |
For the purposes of this Opinion Letter, we have assumed (without making any investigation) that:
| (a) | all copy documents reviewed by us conform to the originals, and all originals are genuine, complete and up-to-date; |
| (b) | all signatures, stamps and seals on any documents submitted to us are genuine; |
| (c) | the executed documents submitted to us have been signed by the persons whose names are indicated thereon as being the names of the signatories and we have assumed the legal capacity (bekwaamheid/capacité) of the natural persons executing such documents; |
| (d) | in the case of draft versions or (or draft updates to) any of the documents reviewed by us, the final and executed versions of such documents are identical in all aspects to such drafts and are duly executed; |
| (e) | the Registration Statement and Prospectus Supplement have or will become effective and have or will be filed in the form referred to in this Opinion Letter; |
| (f) | the Publications give a true, complete and not misleading summary of the matters reflected in the documents on which such excerpts are based and such matters have not been revoked or amended by subsequent decisions by the Company (or its board of directors, general shareholders’ meeting, or any of its other competent bodies or representatives) which were not published in the Annexes to the Belgian Official Gazette; |
| (g) | the Agreement accurately records all terms agreed between the parties to it, and has not been terminated, modified, superseded or varied and none of the parties to the Agreement is or will be seeking to achieve any purpose not apparent from the Agreement; |
| (h) | there have been, and there will be, no amendments or supplements to the documents referred to under paragraph 3 (Documents Reviewed) in the form as examined by us, such documents (or the matters documented therein and thereby) have not been or will not be terminated, rescinded, declared null and void, or revoked, and there are no and will not be dealings, agreements or arrangements, actions or events between, by or involving any of the parties to such documents which supersede any of such documents (or the matters documented therein and thereby), or which otherwise affect the opinion given in this Opinion Letter; |
| (i) | the seat (zetel/siège) of the Company is located in Belgium since its incorporation, and the Company’s sole operational headquarters (exploitatiezetel/siège d’exploitation) are located at the place of its registered office; |
| (j) | the articles of association of the Company have not been amended since the restatement referred to in paragraph 3(d) and accurately restate the original articles of association and the subsequent amendments thereto, except for the amendments required pursuant to the decisions of the board of directors recorded to in the notarial deed referred to in paragraph 3(e)(ii); |
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| (k) | each of the minutes referred to in paragraph 3(e) accurately record resolutions that were duly passed at a properly convened and quorate meeting of duly appointed directors of the Company, conducted in accordance with its articles of association and Belgian law, (ii) do not reflect any untruthful statements, and (iii) have not been amended, revoked, varied or declared null and void, and remain in full force and effect; |
| (l) | the directors of the Company who attended and voted at the board meetings referred to in paragraph 3(e) have complied with the applicable provisions of article 7:96 of the Belgian Companies and Associations Code (as well as article 1.8, §6 of the Belgian Civil Code) dealing with conflicts of interest of directors (as the case may be); |
| (m) | each of the resolutions of the general shareholders’ meetings of the Company referred to, set out or implied in the documents referred to under paragraph 3 (Documents Reviewed) above (i) accurately record resolutions that were duly passed at a properly convened and quorate meeting of genuine shareholders of the Company, conducted in accordance with its articles of association and Belgian law and on the basis of reports of the board of directors (as applicable) duly approved by duly appointed directors, (ii) do not reflect any untruthful statements, and (iii) have not been amended, revoked, varied or declared null and void, and remain in full force and effect; |
| (n) | the directors of the Company have satisfied themselves that the Issuance and the Agreement were entered into for the purpose of carrying out the business of the Company as set out in its articles of association, and that entering into the Issuance and the Agreement is of benefit to the Company, and their conclusions in this respect are not unreasonable; |
| (o) | with respect to each party to the Agreement (other than the Company): |
| (i) | it has been duly incorporated and is validly existing as a legal entity under all laws applicable to that party; |
| (ii) | it has all requisite power and capacity (corporate and otherwise) and, to the extent relevant, has all requisite corporate benefit, to enter into the Agreement to which it is a party, and to perform its obligations thereunder; |
| (iii) | no other action by, and no notice to or filing with, any governmental, administrative or other authority or court on behalf of or by such party is required in order to enable it to validly enter into, sign and perform under the Agreement to which it is a party; |
| (iv) | it has duly authorised, approved and signed the Agreement to which it is a party; |
| (v) | the Agreement constitutes a valid and binding agreement or undertaking of said party, enforceable against it in accordance with the terms and conditions of such Agreement; and |
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| (vi) | if it at any relevant time is carrying on, or purporting to carry on, banking services, investment services or other regulated activity in Belgium, it is at all relevant times an authorised person or an exempt person under the relevant laws of Belgium, and in compliance with all applicable rules and regulations made thereunder; |
| (p) | none of the parties to the Agreement is or will be subject to any contractual restrictions, restrictions imposed by any court, arbitral panel or governmental, administrative or other authority that do not have general (erga omnes) application or similar restrictions binding upon it which would (i) restrict its ability to enter into, assume or perform its obligations under the Issuance and/or the Agreement (except, in relation to the Company, as may be set out in its articles of association), or (ii) have any implication on the opinion given in this Opinion Letter; |
| (q) | none of the Investors has: |
| (i) | resolved to enter into liquidation, been dissolved, been annulled as a legal entity, filed an application for or been subject to proceedings for judicial reorganisation, filed an application for bankruptcy or been declared bankrupt; or |
| (ii) | ceased to pay its debts as they fall due or is subject to measures such as the appointment of a provisional administrator or the sequestration of assets, |
and none of the Investors has taken, or become subject to, similar proceedings or measures in any applicable jurisdiction;
| (r) | each party to the Agreement has complied, and will continue to comply, with the requirements of good faith (goede trouw/bonne foi) and public policy (openbare orde/ordre public), and there has been no mistake of fact (dwaling/erreur), fraud (bedrog/dol), duress (geweld/violence), or abuse of circumstances (misbruik van omstandigheden/abus de circonstances) in relation to the Agreement to which it is a party; |
| (s) | none of the parties to the Agreement is or will be seeking to achieve any purpose not apparent from the Agreement which might render the Agreement illegal or void, and the Agreement have been entered into for bona fide commercial reasons and on arm’s length terms by each of the parties thereto; |
| (t) | the obligations of all parties under the Agreement are binding and enforceable upon them under any applicable law (other than Belgian law), and the exercise and performance by any party to the Agreement of its rights and obligations thereunder is lawful in any place of exercise or performance (other than Belgium); |
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| (u) | any factual circumstances, statements and matters set out in or implied by any of the documents referred to in paragraph 3 (Documents Reviewed) are true, accurate and complete; |
| (v) | there are no provisions of the laws of any jurisdiction outside Belgium which would have any implication for the opinion given in this Opinion Letter and, insofar as the laws of any jurisdiction outside Belgium may be relevant, such laws have been or will be complied with; |
| (w) | for the purpose of the opinion referred to in paragraph 6 (Opinion) in so far as it relates to the actual issuance of the New Shares, (i) the subscription price for the New Shares has been duly paid up and contributed in full, (ii) the New Shares have been duly subscribed for, (iii) the issuance of the New Shares and the corresponding capital increase have been duly recorded in the notarial deed containing the minutes of the meeting of the board of directors of the Company held before notary public referred to in paragraph 3(e)(ii), (iv) such notarial deed and an excerpt therefrom were or will be duly filed and registered as required by Belgian law; |
| (x) | (i) the New Shares have been offered and placed, and have been allocated, and will be traded and listed in each case in the manner and form as described in the Registration Statement, Prospectus Supplement and the Agreement, (ii) no public offering or placement in respect of the New Shares has taken and/or will take place, and no admission to listing and/or trading on a regulated market, multilateral trading facility or other securities market will take place, in Belgium, or elsewhere outside of the United States, in accordance with or as contemplated by Regulation (EU) 2017/1129 of the European Parliament and of the Council of June 14, 2017 on the prospectus to be published when securities are offered to the public or admitted to trading on a regulated market, and repealing Directive 2003/71/EC, as amended from time to time (the “Prospectus Regulation”), the Belgian act of July 11, 2018 on the offering of investment instruments to the public and the admission of investment instruments to the trading on a regulated market, as amended from time to time, or any other relevant rules or regulations, or otherwise; |
| (y) | the undertakings and agreements contained in the Agreement are and will be duly performed and complied with by all parties thereto; |
| (z) | the transactions contemplated by the Issuance and/or the Agreement do not or will not require the publication of a prospectus in accordance with the Prospectus Regulation. |
| 6. | Opinion |
Based upon and subject to the assumptions, qualifications and limitations set out in this Opinion Letter, and subject to any matters, documents or events not disclosed to us, we express the following opinion insofar as Belgian law is concerned:
The New Shares, when duly authorized and sold, issued and fully paid as contemplated in the Prospectus Supplement, the Agreement, and the board resolutions recorded in the board minutes referred to in paragraph 3(e), will be validly issued, fully paid up and non-assessable (meaning that a holder of the relevant New Shares will not by reason of merely being such a holder, be subject to assessment or calls by the Company or its creditors for further payment on such securities).
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| 7. | Qualifications |
The opinion expressed in this Opinion Letter is subject to the following qualifications:
| 7.1. | Reliance on searches and enquiries |
The searches and enquiries referred to in paragraph 4 (Searches and Enquiries) may not be up-to-date and do not constitute conclusive evidence of the matters stated therein.
| 7.2. | Construction of certain terms |
| (a) | In this Opinion Letter Belgian legal concepts which are expressed in English are to be construed in accordance with the Belgian legal concepts to which they refer. |
| (b) | When used in paragraph 6 (Opinion), the terms “legal” and “valid” are references to the legal character of the relevant obligation and the terms “binding” and “enforceable” mean that the relevant obligation or instrument is of a type and form enforced by Belgian courts. None of these means that such an obligation or instrument will be enforced in accordance with its terms in every circumstance, and they are not to be construed as a prediction of the outcome of litigation. |
| 7.3. | Excluded matters |
We do not express an opinion regarding:
| (a) | (i) any laws of any jurisdiction (including, but not limited to, Belgium and the European Union) imposing economic or trade sanctions or similar restrictive measures or regarding anti-terrorism, anti-money laundering, anti-bribery or anti-tax evasion measures, (ii) any regulations enacted, administered, imposed or enforced by any relevant sanctions authority or (iii) the extent, scope, legality or enforceability of any person’s obligation to comply with any of such laws or regulations; |
| (b) | the admission to trading and listing of the New Shares on any regulated market or other trading facility for securities; and |
| (c) | the accuracy or completeness of any statements or warranties of fact set out in documents referred to in paragraph 3 (Documents Reviewed) (except for the representations and warranties as to which we are expressing an opinion), which statements and warranties we have not independently verified. |
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| 8. | Disclosure, Reliance and Liability |
| (a) | This Opinion Letter is issued by Baker McKenzie BV/SRL, a Belgian limited liability company (BV/SRL), and not by or on behalf of Baker & McKenzie International (a Swiss Verein) (“BMI”) or any of its other member or associated firms (together with BMI, the “Other Baker McKenzie Entities”). In this Opinion Letter the expressions “we”, “us”, “our” and like expressions should be construed accordingly. |
| (b) | No Other Baker McKenzie Entity or any directors, shareholders, members, partners, lawyers, employees, contractors or consultants of Baker McKenzie BV/SRL or any Other Baker McKenzie Entity will be liable (whether contractually or non-contractually) to any person under or in connection with this Opinion Letter or in connection with the Agreement or the Issuance. |
| (c) | This Opinion Letter may only be relied upon by the Company in connection with the Registration Statement, and by the subscribers to which the New Shares have been allocated as part of the Issuance. This Opinion Letter is strictly limited to the matters stated in it and may not be read as extending by implication to any matters not specifically referred to in it. Nothing in this Opinion Letter should be taken as expressing an opinion in respect of any representations or warranties, or other information, contained in any document. |
| (d) | We consent to the filing of this Opinion Letter as an exhibit to the Registration Statement and to the reference to us in the Registration Statement and to the reference to us under the heading “Legal Matters” in the Prospectus Supplement. In giving this consent, we do not concede that we are within the category of persons whose consent is required under Section 7 of the Securities Act or the rules and regulations of the SEC thereunder. |
| (e) | This Opinion Letter may only be relied upon, and be disclosed, on condition that it is construed in accordance with Belgian law and that any dispute arising out of or in connection with it is brought before a Belgian court. |
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| Yours faithfully, | ||
| BAKER MCKENZIE BV/SRL | ||
| /s/ Michael Van Acker | /s/ Roel Meers | |
| Michael Van Acker | Roel Meers | |
| Partner | Partner | |
| Michael.VanAcker@bakermckenzie.com | Roel.Meers@bakermckenzie.com | |
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