<SEC-DOCUMENT>0001104659-21-118624.txt : 20211126
<SEC-HEADER>0001104659-21-118624.hdr.sgml : 20211126
<ACCEPTANCE-DATETIME>20210923105646
<PRIVATE-TO-PUBLIC>
ACCESSION NUMBER:		0001104659-21-118624
CONFORMED SUBMISSION TYPE:	CORRESP
PUBLIC DOCUMENT COUNT:		2
FILED AS OF DATE:		20210923

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			PTC THERAPEUTICS, INC.
		CENTRAL INDEX KEY:			0001070081
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				043416587
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		CORRESP

	BUSINESS ADDRESS:	
		STREET 1:		100 CORPORATE COURT
		CITY:			SOUTH PLAINFIELD
		STATE:			NJ
		ZIP:			07080-2449
		BUSINESS PHONE:		9082227000

	MAIL ADDRESS:	
		STREET 1:		100 CORPORATE COURT
		CITY:			SOUTH PLAINFIELD
		STATE:			NJ
		ZIP:			07080-2449

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	PTC THERAPEUTICS INC
		DATE OF NAME CHANGE:	19980909
</SEC-HEADER>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">September&nbsp;23, 2021</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Mr.&nbsp;Gary Newberry</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Ms.&nbsp;Mary Mast</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">Office of Life Sciences</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">United States Securities and Exchange Commission</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">Division of Corporation Finance</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">100 F Street, N.E.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">Washington, DC 20549</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

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    <TD STYLE="vertical-align: top; font-size: 10pt"><FONT STYLE="font-size: 10pt"><B>Re:</B></FONT></TD>
    <TD STYLE="vertical-align: bottom">
    <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>PTC Therapeutics,&nbsp;Inc.</B></P>
    <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Form&nbsp;10-K for the Fiscal Year Ended December&nbsp;31, 2020</B></P>
    <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Filed February&nbsp;25, 2021</B></P>
    <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>File No.&nbsp;001-35969</B></P></TD></TR>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white">Dear Mr.&nbsp;Newberry
and Ms.&nbsp;Mast:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white">This letter is submitted
on behalf of PTC Therapeutics,&nbsp;Inc. (the &ldquo;Company&rdquo; or &ldquo;PTC&rdquo;) in response to written comments of the Staff
(the &ldquo;Staff&rdquo;) of the Securities and Exchange Commission (the &ldquo;Commission&rdquo;) in the letter dated August&nbsp;26,
2021 with respect to the Company&rsquo;s Annual Report on Form&nbsp;10-K for the fiscal year ended December&nbsp;31, 2020, as filed with
the Commission on February&nbsp;25, 2021 (the &ldquo;2020 Form&nbsp;10-K&rdquo;). The Staff&rsquo;s comments are reproduced below and
the Company&rsquo;s corresponding responses follow accordingly.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I><U>Form&nbsp;10-K for the Fiscal Year Ended December&nbsp;31,
2020</U></I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><I><U>Net product revenue, page&nbsp;153</U></I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in"><B><I>1.</I></B></TD><TD STYLE="text-align: justify"><B><I>Quantify in future filings the changes in each significant product and discuss the reason for the
changes. Consider including a table of product revenue by product that is reconciled to Net product revenue on the face of the financial
statements.</I></B></TD></TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>Response: </B>The Company confirms that in
future filings it will specifically quantify the changes in revenue for each significant product and will discuss the reason for the changes.
The Company notes that some of this information is already contained in the 2020 Form&nbsp;10-K, including the reason for changes in net
product revenue. The Company proposes that going forward in the referenced section, it will disclose the year over year changes, and reason
for such change, for overall product revenue as well as broken out for each significant product. The Company will consider including a
table of product revenue by product, once it has additional significant products such that a table would be useful. At this time, with
only two significant products, the Company believes that such a table would be of minimal incremental benefit.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><I><U>Notes to consolidated financial statements</U></I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><B><I><U>2. Summary of
significant accounting policies</U></I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><B><I><U>Segment and
geographic information, page&nbsp;179</U></I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; background-color: white"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in"><B><I>2.</I></B></TD><TD STYLE="text-align: justify"><B><I>Please disclose in future filings the geographic revenue information required by ASC 280-10-50-41
or tell us why the disclosure is not required. In this regard, we note the disclosure of U.S. product sales on page&nbsp;217, but the
remaining revenue is not broken down by country.</I></B></TD></TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><B>Response: </B>The
Company advises the Staff that, pursuant to ASC 280-10-50-41, the Company included in the 2020 Form&nbsp;10-K disclosure of revenues from
external customers for its country of domicile and for those attributable to all other countries in total. The Company agrees that, if
material, separate disclosure is required for each individual foreign country under ASC 280-10-50-41. For fiscal year 2020, the Company
did not consider the revenue of any individual foreign country to be material and therefore did not provide further breakdown by country.
However, if, in future years, the Company deems the revenue of any individual foreign country material, it will provide the necessary
disclosure as required.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><B><I><U>6. Leases, page&nbsp;203</U></I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; background-color: white"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in"><B><I>3.</I></B></TD><TD STYLE="text-align: justify"><B><I>You state that on June&nbsp;19, 2020 you entered into a commercial manufacturing service agreement
for a term of 12.5 years for which you concluded the agreement contains an embedded lease. You also state that given the embedded finance
lease is designed for the production of PTC&rsquo;s AADC program and would not have an alternate use outside the PTC gene therapy platform
you determined the lease should be treated as research and development expense under ASC 730. Accordingly, you expensed the present value
of all guaranteed future cash payments of $41.4 million in 2020. Please tell us and disclose in future filings the following:</I></B></TD></TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; background-color: white"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.5in"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD STYLE="text-align: justify"><B><I>Provide us an analysis of the basis for your accounting treatment under ASC 842.</I></B></TD></TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; background-color: white"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.5in"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD STYLE="text-align: justify"><B><I>Clarify if the $41.4 million was expensed as research and development or recorded as a Right-of-Use
Asset (ROU) as referenced on page&nbsp;204.</I></B></TD></TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; background-color: white"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.5in"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD STYLE="text-align: justify"><B><I>If the $41.4 million is included as a ROU asset on your balance sheet, please tell us where the
amount is presented.</I></B></TD></TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; background-color: white"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.5in"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD STYLE="text-align: justify"><B><I>Clarify if the Finance lease liability on the balance sheet relates to the manufacturing service
agreement.</I></B></TD></TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; background-color: white"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.5in"></TD><TD STYLE="width: 0.25in"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD STYLE="text-align: justify"><B><I>If the $41.4 million is determined to be properly accounted for as a research and development expense,
tell us why recognition in the current year, instead of over the term of the agreement is appropriate.</I></B></TD></TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><B>Response:</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">PTC entered into a Commercial Manufacturing Service
agreement (the &ldquo;Agreement&rdquo;) with the University of Massachusetts (&ldquo;MassBio&rdquo; or &ldquo;MassBiologics&rdquo;) on
June&nbsp;19, 2020. PTC determined that the Agreement included an embedded lease. The Agreement identifies certain manufacturing rooms
of the SouthCoast Facility as PTC&rsquo;s dedicated space. PTC determined the lease of the dedicated space commenced as of the execution
of the Agreement on June&nbsp;19, 2020 for a term of 12.5 years through December&nbsp;31, 2032.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">PTC benefits directly from the dedicated space,
which is the lease component, and the right of use is highly dependent on other services / rights in the Agreement, which are non-lease
components. As disclosed in Footnote 2, Summary of significant accounting policies, of the 2020 Form&nbsp;10-K, PTC accounts for the lease
component and the associated non-lease components as a single component under Accounting Standards Codification (ASC), Leases, 842-10-15-37.
Finally, the present value of the sum of the lease payments was determined to exceed the fair value (as determined by a third-party valuation
firm) of the underlying lease assets associated with the contractual agreement, as such, the finance lease criteria was met. PTC initially
recognized a finance ROU asset and finance lease liability in accordance with ASC 842.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">PTC evaluated the leased asset which is designed
for the production of PTC&rsquo;s AADC program and determined that the ROU assets would not have an alternate use outside the PTC gene
therapy platform without incurring significant costs and modifications to the contract with MassBio. Per ASC 730, the costs of materials,
equipment, or facilities that are acquired or constructed for a particular R&amp;D project and that have no alternative future uses (in
other R&amp;D projects or otherwise) and therefore no separate economic values are R&amp;D costs at the time the costs are incurred. There
is often a high degree of uncertainty about whether R&amp;D expenditures will provide any future benefits. ASC 730 states the general
lack of discernible future benefits at the time R&amp;D costs are incurred indicates that the immediate recognition principle of expense
recognition should apply. As such, PTC evaluated ASC 730, determined that the lease should be treated as research and development expense
and expensed the $41.4 million ROU assets in fiscal year 2020. The finance lease liability did not change as a result of the accounting
treatment for ASC 730.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Finally, PTC confirms that the finance lease liability
on the balance sheet relates to the Mass Bio contract and will clarify its disclosures in the future to make it clear that the liability
relates to that Agreement.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><U>The following is a portion of PTC&rsquo;s prior
year end lease disclosure updated to show how PTC plans to enhance our disclosures in our future filings:</U></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">On June&nbsp;19, 2020, the Company entered into
a commercial manufacturing service agreement for a term of 12.5 years with MassBiologics of the University of Massachusetts Medical School
(&quot;MassBio&quot;). The agreement will expire on December&nbsp;31, 2032 unless the Company terminates it with 24 months prior written
notice to MassBio. Pursuant to the terms of the agreement, MassBio agreed to provide the Company with certain dedicated space for its
gene therapy AADC program. The Company concluded that the agreement contains an embedded lease as the Company controls the use of the
four dedicated rooms and the equipment therein. The agreement included guaranteed lease payments of $15.0 million at the onset of the
agreement and $3.0 million annually thereafter. The present value of the guaranteed lease payments was determined to be $41.4 million,
which exceeded the assessed fair value of the Company&rsquo;s share of the building. Therefore, the Company determined that the agreement
was a finance lease, for which the Company recorded a finance lease ROU asset and corresponding finance lease liability at the onset of
the lease agreement. Given that the leased asset is designed for the production of PTC&rsquo;s AADC program and would not have an alternate
use outside the PTC gene therapy platform without incurring significant costs, the Company determined that the lease should be treated
as research and development expense under ASC 730. Accordingly, the full $41.4 million relating to the finance lease ROU asset was written
off and expensed to research and development during the year ending December&nbsp;31, 2020. The remaining balance for the finance lease
ROU asset related to this arrangement is $0 as of December&nbsp;31, 2020. As of December&nbsp;31, 2020, the balance of the finance lease
liabilities- current and finance lease liabilities- non-current are $1.3 million and $23.1 million, respectively, and are directly related
to the Company&rsquo;s MassBio agreement. Additionally, during the year ending December&nbsp;31, 2020, the Company recorded finance lease
costs of $0.9 million related to interest on the lease liability.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">* * *</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white">Thank you for your consideration
of our response to your comments. Should the Staff have additional questions or comments regarding the foregoing, please do not hesitate
to contact the undersigned at (908) 912-9327.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"></P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
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    <TD STYLE="width: 50%">&nbsp;</TD>
    <TD STYLE="width: 50%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Sincerely,</FONT></TD></TR>
  <TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD>&nbsp;</TD></TR>
  <TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>PTC Therapeutics,&nbsp;Inc.</B></FONT></TD></TR>
  <TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD>&nbsp;</TD></TR>
  <TR STYLE="vertical-align: top">
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></TD>
    <TD STYLE="border-bottom: Black 1pt solid"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">/s/
    Emily Hill</FONT></TD></TR>
  <TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Emily Hill</FONT></TD></TR>
  <TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Chief Financial Officer</FONT></TD></TR>
  </TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"></P>

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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
