<SEC-DOCUMENT>0001558370-22-018553.txt : 20230202
<SEC-HEADER>0001558370-22-018553.hdr.sgml : 20230202
<ACCEPTANCE-DATETIME>20221212165455
<PRIVATE-TO-PUBLIC>
ACCESSION NUMBER:		0001558370-22-018553
CONFORMED SUBMISSION TYPE:	CORRESP
PUBLIC DOCUMENT COUNT:		3
FILED AS OF DATE:		20221212

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			LAVA Therapeutics NV
		CENTRAL INDEX KEY:			0001840748
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				000000000
		STATE OF INCORPORATION:			P7
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		CORRESP

	BUSINESS ADDRESS:	
		STREET 1:		YALELAAN 60
		CITY:			UTRECHT
		STATE:			P7
		ZIP:			3584 CM
		BUSINESS PHONE:		31 6 3000 3035

	MAIL ADDRESS:	
		STREET 1:		YALELAAN 60
		CITY:			UTRECHT
		STATE:			P7
		ZIP:			3584 CM

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	LAVA Therapeutics BV
		DATE OF NAME CHANGE:	20210115
</SEC-HEADER>
<DOCUMENT>
<TYPE>CORRESP
<SEQUENCE>1
<FILENAME>filename1.htm
<TEXT>
<!--Enhanced HTML document created with Toppan Merrill Bridge  9.14.0.96--><!--Created on: 12/12/2022 09:20:22 PM (UTC)--><!DOCTYPE HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN" "http://www.w3.org/TR/html4/loose.dtd"><html><head><meta charset="UTF-8"><title></title></head><body><div style="margin-top:30pt;"></div><div style="max-width:100%;padding-left:11.76%;padding-right:11.76%;position:relative;"><div style="margin-top:30pt;min-height:36pt;width:100%;"><div style="margin-left:0pt;" align="left"><table style="border-collapse:collapse;font-size:16pt;height:max-content;table-layout:auto;width:100%;"><tr style="height:1pt;"><td style="vertical-align:top;width:27.16%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="position:absolute;top:0pt;width:100%;"></div></div></td><td style="vertical-align:top;width:48.88%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="position:absolute;top:0pt;width:100%;"><p style="font-family:'Calibri','Helvetica','sans-serif';font-size:11pt;line-height:1.19;margin:0pt;"><font style="font-size:1pt;visibility:hidden;">&#8203;</font></p></div></div></td><td style="vertical-align:top;width:23.94%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="position:absolute;top:0pt;width:100%;"><p style="font-family:'Times New Roman','Times','serif';font-size:8pt;line-height:10.5pt;margin:0pt;"><font style="display:inline-block;visibility:hidden;width:0pt;">&#8203;</font><br>Fax: 215.864.8999<br>jaslowp@ballardspahr.com</p><p style="font-family:'Calibri','Helvetica','sans-serif';font-size:11pt;line-height:1.19;margin:0pt;"><font style="font-size:1pt;visibility:hidden;">&#8203;</font></p></div></div></td></tr><tr style="height:52.55pt;"><td colspan="3" style="vertical-align:top;width:100%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:12pt;line-height:1.19;margin:1pt 0pt 0pt 0pt;"><img src="tmb-20221212xcorresp001.jpg" alt="Graphic" style="display:inline-block;height:22.49pt;left:0%;padding-bottom:0.05pt;position:relative;top:0pt;width:139.48pt;"></p></td></tr><tr style="height:71.5pt;"><td style="vertical-align:top;width:27.16%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:12pt;line-height:1.19;margin:3pt 0pt 0pt 0pt;"><img src="tmb-20221212xcorresp002.jpg" alt="Graphic" style="display:inline-block;height:54.3pt;left:0%;padding-bottom:0pt;position:relative;top:0pt;width:133.25pt;"></p></td><td style="vertical-align:top;width:48.88%;margin:0pt;padding:0pt;"><p style="font-family:'Calibri','Helvetica','sans-serif';font-size:11pt;line-height:1.19;margin:0pt;"><font style="visibility:hidden;">&#8203;</font></p></td><td style="vertical-align:top;width:23.94%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:8pt;line-height:1.19;margin:5pt 0pt 0pt 0pt;">Mary J Mullany</p><p style="font-family:'Times New Roman','Times','serif';font-size:8pt;line-height:1.19;margin:0pt;">Tel: 215.864.8631</p><p style="font-family:'Times New Roman','Times','serif';font-size:8pt;line-height:1.19;margin:0pt;">Fax: 215-864-8999</p><p style="font-family:'Times New Roman','Times','serif';font-size:8pt;line-height:1.19;margin:0pt;">mullany@ballardspahr.com</p></td></tr></table></div><p style="font-family:'Calibri','Helvetica','sans-serif';font-size:11pt;line-height:1.28;margin:0pt 0pt 8pt 0pt;"><font style="visibility:hidden;">&#8203;</font></p></div><div style="clear:both;max-width:100%;position:relative;"><p style="font-family:'Times New Roman','Times','serif';font-size:12pt;line-height:13pt;margin:0pt 0pt 13pt 0pt;">December 12, 2022</p><p style="font-family:'Times New Roman','Times','serif';font-size:12pt;font-style:italic;line-height:13pt;margin:0pt;"><i><a name="ConfidentialityPhrase"></a></i><font style="font-size:13pt;visibility:hidden;">&#8203;</font></p><p style="font-family:'Times New Roman','Times','serif';font-size:12pt;font-style:italic;line-height:13pt;margin:0pt 0pt 13pt 0pt;"><i><a name="DeliveryMethods"></a></i>By EDGAR</p><div align="left"><table style="border-collapse:collapse;font-size:16pt;height:max-content;padding-bottom:10.8pt;padding-left:0pt;padding-right:5.75pt;table-layout:auto;width:50%;"><tr style="height:1pt;"><td style="vertical-align:top;width:100%;margin:0pt;padding:0pt 5.75pt 10.8pt 0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="position:absolute;top:0pt;width:100%;"><p style="font-family:'Calibri','Helvetica','sans-serif';font-size:11pt;line-height:1.28;margin:0pt 0pt 8pt 0pt;"><a name="lblRe"></a><font style="font-size:1pt;visibility:hidden;">&#8203;</font></p></div></div></td></tr><tr><td style="vertical-align:top;width:100%;margin:0pt;padding:0pt 5.75pt 10.8pt 0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:12pt;line-height:1.19;margin:0pt;">Division of Corporation Finance<br>Office of Life Sciences<br>United States Securities and Exchange Commission<br>Washington, D.C. 20549<br><font style="white-space:pre-wrap;">Attn:   Tara Harkins</font><br><font style="white-space:pre-wrap;">            Eric Atallah</font></p></td></tr></table></div><p style="font-family:'Calibri','Helvetica','sans-serif';font-size:11pt;line-height:1.28;margin:0pt 0pt 8pt 0pt;"><font style="visibility:hidden;">&#8203;</font></p><table border="0" cellpadding="0" cellspacing="0"><tr><td style="vertical-align:text-top;white-space:nowrap;width:36pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:12pt;line-height:1.19;margin-bottom:12pt;margin-top:0pt;">Re:</p></td><td style="padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:12pt;line-height:1.19;margin-bottom:12pt;margin-top:0pt;"><a name="ReLine"></a>LAVA Therapeutics N.V.<br>Form 20-F for the Fiscal Year Ended December 31, 2021<br>Filed March 24, 2022<br><u style="text-decoration-color:#000000;text-decoration-line:underline;text-decoration-style:solid;">File No. 001-40241</u><u style="text-decoration-color:#000000;text-decoration-line:underline;text-decoration-style:solid;"><u style="display:inline-block;overflow:hidden;position:relative;text-align:justify;text-align-last:justify;text-decoration:underline;text-indent:0pt;vertical-align:bottom;white-space:normal;width:170.67pt;">&#8203; &#8203;<font style="display:inline-block;height:0pt;width:100%;"></font></u></u></p></td></tr></table><p style="font-family:'Times New Roman','Times','serif';font-size:12pt;line-height:1.19;margin:0pt 0pt 12pt 0pt;"><a name="Salutation"></a>Ladies and Gentlemen:</p><p style="font-family:'Times New Roman','Times','serif';font-size:12pt;line-height:13pt;margin:0pt 0pt 13pt 0pt;"><font style="white-space:pre-wrap;">This letter responds to the Staff&#8217;s comment letter dated November 29, 2022 to Fred Powell, the Chief Financial Officer of LAVA Therapeutics N.V. (the &#8220;Company&#8221;), regarding the above-captioned Form 20-F.  For your convenience, the Staff&#8217;s comments have been reproduced, followed by the Company&#8217;s response to such comment.  The Company has elected to provide this response letter prior to filing its amended and restated Form 20-F pending resolution of the response to question 2 below.</font></p><p style="font-family:'Calibri','Helvetica','sans-serif';font-size:11pt;line-height:13.1pt;margin:11.19pt 0pt 8pt 0pt;"><font style="font-family:'Times New Roman','Times','serif';font-size:12pt;">Form 20-F for the Fiscal Year Ended December 31, 2021 </font></p><p style="font-family:'Calibri','Helvetica','sans-serif';font-size:11pt;line-height:13.1pt;margin:11.35pt 0pt 8pt 0pt;"><font style="font-family:'Times New Roman','Times','serif';font-size:12pt;">Item 15: Controls and Procedures, page 110 </font></p><div style="margin-top:12.19pt;"></div><table border="0" cellpadding="0" cellspacing="0" style="border-collapse:collapse;font-family:'Calibri','Helvetica','sans-serif';font-size:11pt;line-height:14.4pt;margin-bottom:0pt;margin-top:0pt;table-layout:fixed;width:100%;border:0pt;"><tr><td style="font-family:'Times New Roman','Times','serif';font-size:12pt;vertical-align:baseline;white-space:nowrap;width:36pt;padding:0pt;">1.</td><td style="padding:0pt;"><font style="font-family:'Times New Roman','Times','serif';font-size:12pt;font-style:normal;font-weight:normal;">Please amend the filing to include management&#8217;s assessment of the effectiveness of disclosure controls and procedures as of December 31, 2021. We note the exception identified in Instruction 1 to Item 15 of Form 20-F does not apply to the required assessment in Item 15(a).</font><font style="font-family:'Times New Roman','Times','serif';font-size:12pt;font-style:normal;font-weight:normal;"><br></font><font style="font-family:'Times New Roman','Times','serif';font-size:14.4pt;margin-left:0pt;margin-right:0pt;visibility:hidden;">&#8203;</font></td><td style="width:32.4pt;"></td></tr></table></div><div style="clear:both;margin-bottom:30pt;width:100%;"><p style="font-family:'Calibri','Helvetica','sans-serif';font-size:11pt;line-height:1.19;margin:0pt;"><font style="visibility:hidden;">&#8203;</font></p></div></div><hr style="background-color:#000000;clear:both;color:#000000;height:2pt;line-height:0;margin-bottom:30pt;margin-left:11.76%;margin-right:11.76%;margin-top:30pt;page-break-after:always;width:76.47%;border-width:0;"><div style="max-width:100%;padding-left:11.76%;padding-right:11.76%;position:relative;"><div style="margin-top:30pt;min-height:36pt;width:100%;"><div align="left"><table style="border-collapse:collapse;font-size:16pt;height:max-content;padding-left:0pt;padding-right:0pt;table-layout:auto;width:100%;"><tr style="height:1pt;"><td style="vertical-align:bottom;width:56.73%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td><td style="vertical-align:bottom;width:43.26%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"><p style="font-family:'Calibri','Helvetica','sans-serif';font-size:11pt;line-height:1.19;margin:0pt;"><font style="font-family:'Times New Roman','Times','serif';font-size:12pt;line-height:1.28;margin-bottom:8pt;visibility:hidden;">&#8203;</font></p></div></div></td></tr><tr><td style="vertical-align:bottom;width:56.73%;margin:0pt;padding:0pt;"><p style="font-family:'Calibri','Helvetica','sans-serif';font-size:11pt;line-height:1.19;margin:0pt;"><a name="_Hlk121444228"></a><font style="font-family:'Times New Roman','Times','serif';font-size:12pt;">Division of Corporation Finance</font></p></td><td style="vertical-align:bottom;width:43.26%;margin:0pt;padding:0pt;"><p style="font-family:'Calibri','Helvetica','sans-serif';font-size:11pt;line-height:1.19;margin:0pt;"><font style="font-family:'Times New Roman','Times','serif';font-size:12pt;line-height:1.28;margin-bottom:8pt;visibility:hidden;">&#8203;</font></p></td></tr><tr><td style="vertical-align:bottom;width:56.73%;margin:0pt;padding:0pt;"><p style="font-family:'Calibri','Helvetica','sans-serif';font-size:11pt;line-height:1.19;margin:0pt;"><font style="font-family:'Times New Roman','Times','serif';font-size:12pt;">United States Securities and Exchange Commission</font></p></td><td style="vertical-align:bottom;width:43.26%;margin:0pt;padding:0pt;"><p style="font-family:'Calibri','Helvetica','sans-serif';font-size:11pt;line-height:1.19;margin:0pt;"><font style="font-family:'Times New Roman','Times','serif';font-size:12pt;line-height:1.28;margin-bottom:8pt;visibility:hidden;">&#8203;</font></p></td></tr><tr><td style="vertical-align:bottom;width:56.73%;margin:0pt;padding:0pt;"><p style="font-family:'Calibri','Helvetica','sans-serif';font-size:11pt;line-height:1.19;margin:0pt;"><font style="font-family:'Times New Roman','Times','serif';font-size:12pt;">December 12, 2022</font></p></td><td style="vertical-align:bottom;width:43.26%;margin:0pt;padding:0pt;"><p style="font-family:'Calibri','Helvetica','sans-serif';font-size:11pt;line-height:1.19;margin:0pt;"><font style="font-family:'Times New Roman','Times','serif';font-size:12pt;line-height:1.28;margin-bottom:8pt;visibility:hidden;">&#8203;</font></p></td></tr><tr><td style="vertical-align:bottom;width:56.73%;margin:0pt;padding:0pt;"><p style="font-family:'Calibri','Helvetica','sans-serif';font-size:11pt;line-height:1.19;margin:0pt;"><font style="font-family:'Times New Roman','Times','serif';font-size:12pt;">Page </font><font style="font-family:'Times New Roman','Times','serif';font-size:12pt;">2</font></p></td><td style="vertical-align:bottom;width:43.26%;margin:0pt;padding:0pt;"><p style="font-family:'Calibri','Helvetica','sans-serif';font-size:11pt;line-height:1.19;margin:0pt;"><font style="font-family:'Times New Roman','Times','serif';font-size:12pt;line-height:1.28;margin-bottom:8pt;visibility:hidden;">&#8203;</font></p></td></tr></table></div><p style="font-family:'Calibri','Helvetica','sans-serif';font-size:11pt;line-height:1.28;margin:0pt 0pt 8pt 0pt;"><font style="visibility:hidden;">&#8203;</font></p></div><div style="clear:both;max-width:100%;position:relative;"><p style="font-family:'Times New Roman','Times','serif';font-size:12pt;line-height:13pt;margin:0pt 0pt 13pt 0pt;"><font style="white-space:pre-wrap;">RESPONSE:  The Company will file an Amended and Restated Form 20-F for the Fiscal Year Ended December 31, 2021 (the &#8220;Amended Form 20-F&#8221;) to include, under Item 15(a), management&#8217;s assessment of the effectiveness of disclosure controls and procedures as of December 31, 2021.  Our proposed disclosure is set forth below.</font></p><p style="font-family:'Times New Roman','Times','serif';font-size:12pt;line-height:1.19;margin:0pt 36pt 12pt 36pt;">&#8220;<b style="font-weight:bold;text-decoration-color:#000000;text-decoration-line:underline;text-decoration-style:solid;">Disclosure Controls and Procedures</b></p><p style="font-family:'Times New Roman','Times','serif';font-size:12pt;line-height:1.19;margin:0pt 36pt 12pt 36pt;">As of December&#160;31, 2021, under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, we performed an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rule&#160;13a-15(e)&#160;<font style="white-space:pre-wrap;">under the Exchange Act). There are inherent limitations to the effectiveness of any disclosure controls and procedures system, including the possibility of human error and circumventing or overriding them.  Accordingly, even if effective, disclosure controls and procedures can provide only reasonable assurance of achieving their control objectives.  Our disclosure controls and procedures are designed to ensure that information required to be disclosed in the reports we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC&#8217;s rules and forms and that such information is accumulated and communicated to management, including the Chief Executive Officer and Chief Financial Officer, to allow timely decisions regarding required disclosure.</font></p><p style="font-family:'Times New Roman','Times','serif';font-size:12pt;line-height:1.19;margin:0pt 36pt 12pt 36pt;">Based on such evaluation, as of December 31, 2021, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were not effective due to material weaknesses in our internal control over financial reporting primarily related to (a) the lack of consistent and documented risk assessment procedures and control activities related to our financial reporting, among which are a sufficient level of management review and approval, manual processes, roles and responsibilities, and adequate application and controls over information technology and (b) our ability to: (i)&#160;<font style="white-space:pre-wrap;">design and maintain formal accounting policies, procedures and controls over the fair presentation of our financial statements; and (ii) design and maintain controls over the preparation and review of journal entries and financial statements, including maintaining appropriate segregation of duties.  </font></p><p style="font-family:'Times New Roman','Times','serif';font-size:12pt;line-height:1.19;margin:0pt 36pt 0pt 36pt;"><font style="white-space:pre-wrap;">While we took steps during the year ended December 31, 2021 to remediate these material weaknesses and have enhanced our internal control over financial reporting in preparation for compliance with Section 404(a) of the Sarbanes-Oxley Act for the year ending December 31, 2022, such remediation measures have been operational for a limited period of time and have not been tested. As such, we cannot consider these material weaknesses as remediated as of December 31, 2021.  We have therefore developed a remediation plan designed to address these material weaknesses and other existing deficiencies.  Such plan </font></p></div><div style="clear:both;margin-bottom:30pt;width:100%;"><p style="font-family:'Calibri','Helvetica','sans-serif';font-size:11pt;line-height:1.19;margin:0pt;"><font style="visibility:hidden;">&#8203;</font></p></div></div><hr style="background-color:#000000;clear:both;color:#000000;height:2pt;line-height:0;margin-bottom:30pt;margin-left:11.76%;margin-right:11.76%;margin-top:30pt;page-break-after:always;width:76.47%;border-width:0;"><div style="max-width:100%;padding-left:11.76%;padding-right:11.76%;position:relative;"><div style="margin-top:30pt;min-height:36pt;width:100%;"><div align="left"><table style="border-collapse:collapse;font-size:16pt;height:max-content;padding-left:0pt;padding-right:0pt;table-layout:auto;width:100%;"><tr style="height:1pt;"><td style="vertical-align:bottom;width:56.73%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td><td style="vertical-align:bottom;width:43.26%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"><p style="font-family:'Calibri','Helvetica','sans-serif';font-size:11pt;line-height:1.19;margin:0pt;"><font style="font-family:'Times New Roman','Times','serif';font-size:12pt;line-height:1.28;margin-bottom:8pt;visibility:hidden;">&#8203;</font></p></div></div></td></tr><tr><td style="vertical-align:bottom;width:56.73%;margin:0pt;padding:0pt;"><p style="font-family:'Calibri','Helvetica','sans-serif';font-size:11pt;line-height:1.19;margin:0pt;"><a name="_Hlk121444228"></a><font style="font-family:'Times New Roman','Times','serif';font-size:12pt;">Division of Corporation Finance</font></p></td><td style="vertical-align:bottom;width:43.26%;margin:0pt;padding:0pt;"><p style="font-family:'Calibri','Helvetica','sans-serif';font-size:11pt;line-height:1.19;margin:0pt;"><font style="font-family:'Times New Roman','Times','serif';font-size:12pt;line-height:1.28;margin-bottom:8pt;visibility:hidden;">&#8203;</font></p></td></tr><tr><td style="vertical-align:bottom;width:56.73%;margin:0pt;padding:0pt;"><p style="font-family:'Calibri','Helvetica','sans-serif';font-size:11pt;line-height:1.19;margin:0pt;"><font style="font-family:'Times New Roman','Times','serif';font-size:12pt;">United States Securities and Exchange Commission</font></p></td><td style="vertical-align:bottom;width:43.26%;margin:0pt;padding:0pt;"><p style="font-family:'Calibri','Helvetica','sans-serif';font-size:11pt;line-height:1.19;margin:0pt;"><font style="font-family:'Times New Roman','Times','serif';font-size:12pt;line-height:1.28;margin-bottom:8pt;visibility:hidden;">&#8203;</font></p></td></tr><tr><td style="vertical-align:bottom;width:56.73%;margin:0pt;padding:0pt;"><p style="font-family:'Calibri','Helvetica','sans-serif';font-size:11pt;line-height:1.19;margin:0pt;"><font style="font-family:'Times New Roman','Times','serif';font-size:12pt;">December 12, 2022</font></p></td><td style="vertical-align:bottom;width:43.26%;margin:0pt;padding:0pt;"><p style="font-family:'Calibri','Helvetica','sans-serif';font-size:11pt;line-height:1.19;margin:0pt;"><font style="font-family:'Times New Roman','Times','serif';font-size:12pt;line-height:1.28;margin-bottom:8pt;visibility:hidden;">&#8203;</font></p></td></tr><tr><td style="vertical-align:bottom;width:56.73%;margin:0pt;padding:0pt;"><p style="font-family:'Calibri','Helvetica','sans-serif';font-size:11pt;line-height:1.19;margin:0pt;"><font style="font-family:'Times New Roman','Times','serif';font-size:12pt;">Page </font><font style="font-family:'Times New Roman','Times','serif';font-size:12pt;">3</font></p></td><td style="vertical-align:bottom;width:43.26%;margin:0pt;padding:0pt;"><p style="font-family:'Calibri','Helvetica','sans-serif';font-size:11pt;line-height:1.19;margin:0pt;"><font style="font-family:'Times New Roman','Times','serif';font-size:12pt;line-height:1.28;margin-bottom:8pt;visibility:hidden;">&#8203;</font></p></td></tr></table></div><p style="font-family:'Calibri','Helvetica','sans-serif';font-size:11pt;line-height:1.28;margin:0pt 0pt 8pt 0pt;"><font style="visibility:hidden;">&#8203;</font></p></div><div style="clear:both;max-width:100%;position:relative;"><p style="font-family:'Times New Roman','Times','serif';font-size:12pt;line-height:1.19;margin:0pt 36pt 12pt 36pt;"><font style="white-space:pre-wrap;">includes the redesign of critical processes and controls associated with internal control over financial reporting.  Based on such plan, we are currently implementing additional processes and measures to ensure operating effectiveness.  Specifically, we are implementing proper segregation of duties and management review and approvals across all key business processes, and have hired additional internal and external accounting resources.  Although we intend to complete the remediation plan as soon as possible, we cannot guarantee at this time when such remediation steps will be completed, and management may determine the need to enhance other existing controls and procedures or implement additional controls as the remediation progresses.&#8221; </font></p><p style="font-family:'Times New Roman','Times','serif';font-size:12pt;line-height:1.19;margin:0pt 0pt 12pt 0pt;"><u style="text-decoration-color:#000000;text-decoration-line:underline;text-decoration-style:solid;">Item 17: Financial Statements </u><font style="text-decoration-line:none;"><br></font><u style="text-decoration-color:#000000;text-decoration-line:underline;text-decoration-style:solid;">Report of Independent Registered Public Accounting Firm, page F-1 </u></p><table border="0" cellpadding="0" cellspacing="0" style="border-collapse:collapse;font-family:'Times New Roman','Times','serif';font-size:11pt;line-height:13pt;margin-bottom:0pt;margin-top:0pt;table-layout:fixed;width:100%;border:0pt;"><tr><td style="font-family:'Times New Roman','Times','serif';font-size:12pt;vertical-align:baseline;white-space:nowrap;width:36pt;padding:0pt;">2.</td><td style="padding:0pt;"><font style="font-family:'Times New Roman','Times','serif';font-size:12pt;font-style:normal;font-weight:normal;">We note that your independent registered public accounting firm did not opine on your January 1, 2020 consolidated statement of financial position. Please amend the filing to have your independent registered public accounting firm opine on this statement, or tell us why this is not considered necessary. Refer to Item 8(A)(3) of Form 20-F and Item 2-02 of Regulation S-X.</font></td></tr></table><div style="margin-top:13pt;"></div><p style="font-family:'Times New Roman','Times','serif';font-size:12pt;line-height:1.19;margin:0pt 0pt 12pt 0pt;"><font style="white-space:pre-wrap;">RESPONSE:  The Company respectfully acknowledges the Staff&#8217;s comment and advises that in accordance with paragraph 40A(b) of IAS 1, the additional comparative statement of financial position has been presented as an additional disclosure, as the change in reporting currency from Euro to USD disclosed in Note 2.c to our Annual Report on Form 20-F has a material effect on the information in the statement of financial position at the beginning of the period ended December 31, 2020. </font></p><p style="font-family:'Times New Roman','Times','serif';font-size:12pt;line-height:1.19;margin:0pt 0pt 12pt 0pt;">As a consequence, the additional January 1, 2020 IFRS balance sheet is not a comparative financial statement contemplated by item 8(A)(3) of Form 20-F. Rather, it is a disclosure required by paragraph 40A(b) of IAS 1-IASB which has been audited together with the financial statements. Therefore, our independent registered public accounting firm does not refer to the additional January 1, 2020 IFRS balance sheet in its audit opinion. </p><p style="font-family:'Times New Roman','Times','serif';font-size:12pt;line-height:13pt;margin:0pt 0pt 13pt 0pt;"><font style="white-space:pre-wrap;">We acknowledge the Company&#8217;s and its management&#8217;s responsibility for the accuracy and adequacy of the Company&#8217;s disclosures.  Please contact me at (215) 864-8631 with any questions or comments you may have regarding this response.  The Company&#8217;s management is available for discussion as needed to resolve these comments.  </font></p><p style="font-family:'Times New Roman','Times','serif';font-size:12pt;line-height:1.19;margin:0pt;"><a name="Closing"></a>Very truly yours,</p><p style="font-family:'Times New Roman','Times','serif';font-size:12pt;line-height:1.19;margin:0pt;"><font style="line-height:13pt;margin-bottom:39pt;visibility:hidden;">&#8203;</font></p><p style="font-family:'Times New Roman','Times','serif';font-size:12pt;line-height:1.19;margin:0pt;">/s/ Mary J Mullany</p><p style="font-family:'Times New Roman','Times','serif';font-size:12pt;line-height:1.19;margin:0pt;"><font style="line-height:13pt;margin-bottom:39pt;visibility:hidden;">&#8203;</font></p><p style="font-family:'Times New Roman','Times','serif';font-size:12pt;line-height:1.19;margin:0pt;"><a name="FromSignature"></a>Mary J. Mullany</p><p style="font-family:'Times New Roman','Times','serif';font-size:12pt;line-height:13pt;margin:13pt 0pt 0pt 0pt;"><a name="Initials"></a>MJM/lrk</p></div><div style="clear:both;margin-bottom:30pt;width:100%;"><p style="font-family:'Calibri','Helvetica','sans-serif';font-size:11pt;line-height:1.19;margin:0pt;"><font style="visibility:hidden;">&#8203;</font></p></div></div><hr style="background-color:#000000;clear:both;color:#000000;height:2pt;line-height:0;margin-bottom:30pt;margin-left:11.76%;margin-right:11.76%;margin-top:30pt;page-break-after:always;width:76.47%;border-width:0;"><div style="max-width:100%;padding-left:11.76%;padding-right:11.76%;position:relative;"><div style="margin-top:30pt;min-height:36pt;width:100%;"><div align="left"><table style="border-collapse:collapse;font-size:16pt;height:max-content;padding-left:0pt;padding-right:0pt;table-layout:auto;width:100%;"><tr style="height:1pt;"><td style="vertical-align:bottom;width:56.73%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td><td style="vertical-align:bottom;width:43.26%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"><p style="font-family:'Calibri','Helvetica','sans-serif';font-size:11pt;line-height:1.19;margin:0pt;"><font style="font-family:'Times New Roman','Times','serif';font-size:12pt;line-height:1.28;margin-bottom:8pt;visibility:hidden;">&#8203;</font></p></div></div></td></tr><tr><td style="vertical-align:bottom;width:56.73%;margin:0pt;padding:0pt;"><p style="font-family:'Calibri','Helvetica','sans-serif';font-size:11pt;line-height:1.19;margin:0pt;"><a name="_Hlk121444228"></a><font style="font-family:'Times New Roman','Times','serif';font-size:12pt;">Division of Corporation Finance</font></p></td><td style="vertical-align:bottom;width:43.26%;margin:0pt;padding:0pt;"><p style="font-family:'Calibri','Helvetica','sans-serif';font-size:11pt;line-height:1.19;margin:0pt;"><font style="font-family:'Times New Roman','Times','serif';font-size:12pt;line-height:1.28;margin-bottom:8pt;visibility:hidden;">&#8203;</font></p></td></tr><tr><td style="vertical-align:bottom;width:56.73%;margin:0pt;padding:0pt;"><p style="font-family:'Calibri','Helvetica','sans-serif';font-size:11pt;line-height:1.19;margin:0pt;"><font style="font-family:'Times New Roman','Times','serif';font-size:12pt;">United States Securities and Exchange Commission</font></p></td><td style="vertical-align:bottom;width:43.26%;margin:0pt;padding:0pt;"><p style="font-family:'Calibri','Helvetica','sans-serif';font-size:11pt;line-height:1.19;margin:0pt;"><font style="font-family:'Times New Roman','Times','serif';font-size:12pt;line-height:1.28;margin-bottom:8pt;visibility:hidden;">&#8203;</font></p></td></tr><tr><td style="vertical-align:bottom;width:56.73%;margin:0pt;padding:0pt;"><p style="font-family:'Calibri','Helvetica','sans-serif';font-size:11pt;line-height:1.19;margin:0pt;"><font style="font-family:'Times New Roman','Times','serif';font-size:12pt;">December 12, 2022</font></p></td><td style="vertical-align:bottom;width:43.26%;margin:0pt;padding:0pt;"><p style="font-family:'Calibri','Helvetica','sans-serif';font-size:11pt;line-height:1.19;margin:0pt;"><font style="font-family:'Times New Roman','Times','serif';font-size:12pt;line-height:1.28;margin-bottom:8pt;visibility:hidden;">&#8203;</font></p></td></tr><tr><td style="vertical-align:bottom;width:56.73%;margin:0pt;padding:0pt;"><p style="font-family:'Calibri','Helvetica','sans-serif';font-size:11pt;line-height:1.19;margin:0pt;"><font style="font-family:'Times New Roman','Times','serif';font-size:12pt;">Page </font><font style="font-family:'Times New Roman','Times','serif';font-size:12pt;">4</font></p></td><td style="vertical-align:bottom;width:43.26%;margin:0pt;padding:0pt;"><p style="font-family:'Calibri','Helvetica','sans-serif';font-size:11pt;line-height:1.19;margin:0pt;"><font style="font-family:'Times New Roman','Times','serif';font-size:12pt;line-height:1.28;margin-bottom:8pt;visibility:hidden;">&#8203;</font></p></td></tr></table></div><p style="font-family:'Calibri','Helvetica','sans-serif';font-size:11pt;line-height:1.28;margin:0pt 0pt 8pt 0pt;"><font style="visibility:hidden;">&#8203;</font></p></div><div style="clear:both;max-width:100%;position:relative;"><p style="font-family:'Times New Roman','Times','serif';font-size:12pt;line-height:13pt;margin:0pt;"><a name="Enclosure"></a><font style="font-size:13pt;visibility:hidden;">&#8203;</font></p><p style="font-family:'Calibri','Helvetica','sans-serif';font-size:11pt;line-height:1.28;margin:0pt 0pt 8pt 0pt;"><font style="display:inline-block;text-indent:0pt;width:36pt;"><font style="font-family:'Calibri','Helvetica','sans-serif';font-size:11pt;font-style:normal;font-weight:normal;"><a name="cc"></a></font><font style="font-family:'Times New Roman','Times','serif';font-size:12pt;font-style:normal;font-weight:normal;">cc:</font></font><font style="font-family:'Times New Roman','Times','serif';font-size:12pt;">Fred Powell</font><font style="font-family:'Times New Roman','Times','serif';font-size:12pt;"><br></font><font style="font-family:'Times New Roman','Times','serif';font-size:12pt;">Michael McNamara</font><font style="font-family:'Times New Roman','Times','serif';font-size:12pt;"><br></font><font style="font-family:'Times New Roman','Times','serif';font-size:12pt;">Amy Garabedian</font></p></div><div style="clear:both;margin-bottom:30pt;width:100%;"><p style="font-family:'Calibri','Helvetica','sans-serif';font-size:11pt;line-height:1.19;margin:0pt;"><font style="visibility:hidden;">&#8203;</font></p></div></div><hr 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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
