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<SEC-DOCUMENT>0000950123-10-102145.txt : 20101108
<SEC-HEADER>0000950123-10-102145.hdr.sgml : 20101108
<ACCEPTANCE-DATETIME>20101108080537
ACCESSION NUMBER:		0000950123-10-102145
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20101108
ITEM INFORMATION:		Results of Operations and Financial Condition
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20101108
DATE AS OF CHANGE:		20101108

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			TRANSDEL PHARMACEUTICALS INC
		CENTRAL INDEX KEY:			0001360214
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				450567010
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	000-52998
		FILM NUMBER:		101170730

	BUSINESS ADDRESS:	
		STREET 1:		4225 EXECUTIVE SQUARE
		STREET 2:		SUITE 485
		CITY:			LA JOLLA
		STATE:			CA
		ZIP:			92037
		BUSINESS PHONE:		(858) 457-5300

	MAIL ADDRESS:	
		STREET 1:		4225 EXECUTIVE SQUARE
		STREET 2:		SUITE 485
		CITY:			LA JOLLA
		STATE:			CA
		ZIP:			92037

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	Bywater Resources, Inc
		DATE OF NAME CHANGE:	20060421
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
<SEQUENCE>1
<FILENAME>c08024e8vk.htm
<DESCRIPTION>FORM 8-K
<TEXT>
<HTML>
<HEAD>
<TITLE>Form 8-K</TITLE>
</HEAD>
<BODY bgcolor="#FFFFFF">
<!-- PAGEBREAK -->

<DIV style="font-family: 'Times New Roman',Times,serif; margin-left: .25in; width: 7.50in">



<DIV style="font-size: 10pt">
<DIV style="width: 100%; border-bottom: 2pt solid black; font-size: 1pt">&nbsp;</DIV>
<DIV style="width: 100%; border-bottom: 1pt solid black; font-size: 1pt">&nbsp;</DIV>


<P align="center" style="font-size: 14pt"><B>UNITED STATES<BR>
SECURITIES AND EXCHANGE COMMISSION<BR>
<FONT style="font-size: 12pt">Washington, D.C. 20549
</FONT></B>

<P align="center" style="font-size: 18pt"><B>FORM 8-K</B>

<P align="center" style="font-size: 12pt"><B>CURRENT REPORT<BR>
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934</B>

<P align="center" style="font-size: 10pt"><B>Date of Report (Date of earliest event reported): November 8, 2010</B>

<P align="center">

<P align="center" style="font-size: 24pt"><B>TRANSDEL PHARMACEUTICALS, INC.<BR></B>
<FONT style="font-size: 10pt">(Exact name of registrant as specified in its charter)
</FONT>

<TABLE border="0" width="100%" cellspacing="0" cellpadding="0" style="font-size: 10pt; text-align: center">
<TR>
    <TD width="32%">&nbsp;</TD>
    <TD width="1%">&nbsp;</TD>
    <TD width="33%">&nbsp;</TD>
    <TD width="1%">&nbsp;</TD>
    <TD width="32%">&nbsp;</TD>
</TR>
<TR valign="bottom">
    <TD style="border-bottom: 1px solid #000000"><B>Delaware</B></TD>
    <TD>&nbsp;</TD>
    <TD style="border-bottom: 1px solid #000000"><B>000-52998</B></TD>
    <TD>&nbsp;</TD>
    <TD style="border-bottom: 1px solid #000000"><B>45-0567010</B></TD>
</TR>
<TR valign="top">
    <TD>(State or other Jurisdiction of Incorporation)</TD>
    <TD>&nbsp;</TD>
    <TD>(Commission File Number)</TD>
    <TD>&nbsp;</TD>
    <TD>(IRS Employer Identification No.)</TD>
</TR>
</TABLE>

<TABLE border="0" width="100%" cellspacing="0" cellpadding="0" style="font-size: 10pt; text-align: center">
<TR>
    <TD width="49%">&nbsp;</TD>
    <TD width="1%">&nbsp;</TD>
    <TD width="49%">&nbsp;</TD>
</TR>
<TR valign="bottom">
    <TD style="border-bottom: 1px solid #000000"><B>4275 Executive Square, Suite 230, La Jolla, California<BR></B></TD>
    <TD>&nbsp;</TD>
    <TD style="border-bottom: 1px solid #000000"><B>92037</B></TD>
</TR>
<TR valign="top">
    <TD>(Address of Principal Executive Offices)</TD>
    <TD>&nbsp;</TD>
    <TD>(Zip Code)</TD>
</TR>
</TABLE>

<P align="center" style="font-size: 10pt">Registrant&#146;s telephone number, including area code: <B>(858) 457-5300</B>


<TABLE border="0" width="30%" cellspacing="0" cellpadding="0" style="font-size: 10pt; text-align: center">
<TR>
    <TD width="100%">&nbsp;</TD>
</TR>
<TR>
    <TD nowrap style="border-bottom: 1px solid #000000"><B>Not Applicable<BR></B></TD>
</TR>
<TR>
    <TD nowrap>(Former name or former address if changed since last report.)</TD>
</TR>
</TABLE>

<P align="left" style="font-size: 10pt">Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant
under any of the following provisions:

<P align="left" style="font-size: 10pt">
<FONT face="Wingdings">&#111;</FONT> Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)<BR><BR>
<FONT face="Wingdings">&#111;</FONT> Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)<BR><BR>
<FONT face="Wingdings">&#111;</FONT> Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))<BR><BR>
<FONT face="Wingdings">&#111;</FONT> Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))<BR>


<P>
<DIV style="width: 100%; border-bottom: 1pt solid black; margin-top: 10pt; font-size: 1pt">&nbsp;</DIV>
<DIV style="width: 100%; border-bottom: 2pt solid black; font-size: 1pt">&nbsp;</DIV>

</DIV>

<P align="center" style="font-size: 10pt">&nbsp;

<P align="center" style="font-size: 10pt; display: none">1
</DIV>

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<P><HR noshade><P>
<H5 align="left" style="page-break-before:always">&nbsp;</H5><P>

<DIV style="font-family: 'Times New Roman',Times,serif; margin-left: .25in; width: 7.50in">

<P align="left" style="font-size: 10pt"><B>Item&nbsp;2.02. Results of Operations and Financial Condition.</B>


<P align="left" style="font-size: 10pt">On November&nbsp;8, 2010, Transdel Pharmaceuticals, Inc. issued a press release announcing, among other things, its
unaudited financial results for the three and nine month periods ended September&nbsp;30, 2010. A copy of the press release
is attached as Exhibit&nbsp;99.1 to this Current Report.


<P align="left" style="font-size: 10pt">The information in this Item&nbsp;2.02, and Exhibit&nbsp;99.1 attached hereto, is being furnished and shall not be deemed &#147;filed&#148;
for the purposes of Section&nbsp;18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the
liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of
1933, as amended, regardless of any general incorporation language in such filing.


<P align="left" style="font-size: 10pt"><B>Item&nbsp;9.01. Financial Statements and Exhibits.</B>


<P align="left" style="font-size: 10pt">(d)&nbsp;Exhibits.


<P align="left" style="font-size: 10pt">99.1 &nbsp;&nbsp;&nbsp;&nbsp;Press release issued by Transdel Pharmaceuticals, Inc. on November&nbsp;8, 2010.


<P align="center" style="font-size: 10pt">&nbsp;

<P align="center" style="font-size: 10pt; display: none">2
</DIV>

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<P><HR noshade><P>
<H5 align="left" style="page-break-before:always">&nbsp;</H5><P>

<DIV style="font-family: 'Times New Roman',Times,serif; margin-left: .25in; width: 7.50in">

<P align="center" style="font-size: 10pt"><B>SIGNATURE</B>



<P align="left" style="font-size: 10pt">Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be
signed on its behalf by the undersigned thereunto duly authorized.


<P align="left" style="font-size: 10pt">Dated: November&nbsp;8, 2010


<P align="left" style="font-size: 10pt; margin-left: 48%">TRANSDEL PHARMACEUTICALS, INC.


<P align="left" style="font-size: 10pt; margin-left: 48%">By:<U> <B>/</B>s/ John Lomoro </U><BR>
John Lomoro<br>Chief Financial Officer




<P align="center" style="font-size: 10pt">&nbsp;

<P align="center" style="font-size: 10pt; display: none">3
</DIV>

<!-- PAGEBREAK -->
<P><HR noshade><P>
<H5 align="left" style="page-break-before:always">&nbsp;</H5><P>

<DIV style="font-family: 'Times New Roman',Times,serif; margin-left: .25in; width: 7.50in">

<P align="center" style="font-size: 10pt"><B>INDEX TO EXHIBITS</B>


<DIV align="center">
<TABLE style="font-size: 10pt" cellspacing="0" border="0" cellpadding="0" width="100%">
<!-- Begin Table Head -->
<TR valign="bottom">
    <TD width="8%">&nbsp;</TD>
    <TD width="5%">&nbsp;</TD>
    <TD width="87%">&nbsp;</TD>
</TR>
<TR style="font-size: 10pt" valign="bottom">
    <TD nowrap align="left" style="border-bottom: 1px solid #000000"><B>Exhibit No.</B></TD>
    <TD>&nbsp;</TD>
    <TD nowrap align="center" style="border-bottom: 1px solid #000000"><B>Description</B></TD>
</TR>

<!-- End Table Head -->
<!-- Begin Table Body -->
<TR valign="bottom">
    <TD valign="top"><DIV style="margin-left:0px; text-indent:-0px">99.1
</DIV></TD>
    <TD>&nbsp;</TD>
    <TD align="left" valign="top">Press release issued by Transdel Pharmaceuticals, Inc. on
November&nbsp;8, 2010.</TD>
</TR>
<!-- End Table Body -->
</TABLE>
</DIV>


<P align="center" style="font-size: 10pt">&nbsp;

<P align="center" style="font-size: 10pt; display: none">4




</DIV>
</BODY>
</HTML>
</TEXT>
</DOCUMENT>
<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>c08024exv99w1.htm
<DESCRIPTION>EXHIBIT 99.1
<TEXT>
<HTML>
<HEAD>
<TITLE>Exhibit 99.1</TITLE>
</HEAD>
<BODY bgcolor="#FFFFFF">
<!-- PAGEBREAK -->
<DIV style="font-family: 'Times New Roman',Times,serif; margin-left: .25in; width: 7.50in">

<DIV align="right" style="font-size: 10pt; margin-top: 10pt"><B>Exhibit&nbsp;99.1</B>
</DIV>

<DIV align="center">
<TABLE style="font-size: 10pt" cellspacing="0" border="0" cellpadding="0" width="100%">
<!-- Begin Table Head --><TR valign="bottom">
    <TD width="48%">&nbsp;</TD>
    <TD width="4%">&nbsp;</TD>
    <TD width="48%">&nbsp;</TD>
</TR>

<!-- End Table Head -->
<!-- Begin Table Body -->
<TR valign="bottom">
    <TD valign="top"><DIV style="margin-left:0px; text-indent:-0px"><IMG src="c08024p0802401.jpg" alt="(TRANSDEL PHARAMACEUTICALS LOGO)">
</DIV></TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="middle"><B>News Release</B></TD>
</TR>
<!-- End Table Body --></TABLE>
</DIV>


<DIV align="center" style="font-size: 10pt; margin-top: 10pt"><B>Transdel Pharmaceuticals Reports Third Quarter and Year-to-Date 2010 Results</B>
</DIV>


<DIV align="justify" style="font-size: 10pt; margin-top: 10pt">LA JOLLA, CA &#151; November&nbsp;8, 2010 &#151; Transdel Pharmaceuticals, Inc. (OTCBB: TDLP), a specialty
pharmaceutical company focused on developing topically administered products using its proprietary
transdermal delivery platform, today announced financial results for the three and nine months
ended September&nbsp;30, 2010 and other recent achievements.
</DIV>

<DIV align="justify" style="font-size: 10pt; margin-top: 10pt"><U><B>Recent Achievements</B></U>
</DIV>


<DIV style="margin-top: 10pt">
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">
<TR valign="top" style="font-size: 10pt; color: #000000; background: transparent">
    <TD width="4%" style="background: transparent">&nbsp;</TD>
    <TD width="3%" nowrap align="left"><B>&#149;</B></TD>
    <TD width="1%">&nbsp;</TD>
    <TD><DIV style="text-align: justify">On September&nbsp;2, 2010, the Company presented the final data set from its Phase 3 study
for Ketotransdel at the 13<SUP style="font-size: 85%; vertical-align: text-top">th</SUP> World Congress on Pain in Montreal, Canada.</DIV></TD>
</TR>

<TR style="font-size: 8pt">
    <TD>&nbsp;</TD>
</TR> <TR valign="top" style="font-size: 10pt; color: #000000; background: transparent">
    <TD width="4%" style="background: transparent">&nbsp;</TD>
    <TD width="3%" nowrap align="left"><B>&#149;</B></TD>
    <TD width="1%">&nbsp;</TD>
    <TD><DIV style="text-align: justify">On September&nbsp;9, 2010, the Company reported that JH Direct completed their initial
product testing of the Company&#146;s anti-cellulite formulation in 24 subjects, which consisted
of observing the before and after results of applying the product over a 16-week period.
The positive results observed during this test have led JH Direct to initiate plans for a
final test in approximately 25 subjects to be conducted by a third-party skin research
center. JH Direct is planning a commercial launch of the product for the first quarter of
2011 subject to successful completion of the final test<B>.</B></DIV></TD>
</TR>

<TR style="font-size: 8pt">
    <TD>&nbsp;</TD>
</TR> <TR valign="top" style="font-size: 10pt; color: #000000; background: transparent">
    <TD width="4%" style="background: transparent">&nbsp;</TD>
    <TD width="3%" nowrap align="left"><B>&#149;</B></TD>
    <TD width="1%">&nbsp;</TD>
    <TD><DIV style="text-align: justify">On October&nbsp;21, 2010 the Company announced the appointment of John N. Bonfiglio, Ph.D.
as Chief Executive Officer and President. Dr.&nbsp;Bonfiglio will also serve as a director on
Transdel&#146;s Board of Directors. Dr.&nbsp;Bonfiglio brings to the Company over 27&nbsp;years of
pharmaceutical industry experience, which includes working with pharmaceutical companies
during the development stage as well as those with commercialized products. Given his
experience, the Board of Directors is extremely pleased to have Dr.&nbsp;Bonfiglio join Transdel
to continue to drive the vision of the Company.</DIV></TD>
</TR>

<TR style="font-size: 8pt">
    <TD>&nbsp;</TD>
</TR> <TR valign="top" style="font-size: 10pt; color: #000000; background: transparent">
    <TD width="4%" style="background: transparent">&nbsp;</TD>
    <TD width="3%" nowrap align="left"><B>&#149;</B></TD>
    <TD width="1%">&nbsp;</TD>
    <TD><DIV style="text-align: justify">On November&nbsp;1, 2010, the Company received notice from the U.S. Internal Revenue Service
that it was approved to receive a Federal grant in the amount of approximately $244,000
under the Qualifying Therapeutic Discovery Project that is part of the Patient Protection
and Affordable Care Act. The funds were awarded in support of Ketotransdel, the Company&#146;s
late-stage topical NSAID for the treatment of acute soft tissue injuries. The Company
expects to receive the funds by the end of 2010.</DIV></TD>
</TR>

</TABLE>
</DIV>

<DIV align="justify" style="font-size: 10pt; margin-top: 10pt"><U><B>Third Quarter and Year-to-Date 2010 Financial Results </B></U>
</DIV>


<DIV align="justify" style="font-size: 10pt; margin-top: 10pt">As of September&nbsp;30, 2010, the Company had cash and cash equivalents of approximately $0.5&nbsp;million,
compared to $1.0&nbsp;million at June&nbsp;30, 2010. However, as noted above, on November&nbsp;1, 2010, the
Company was notified that they will receive $244,000 under the Qualifying Therapeutic Discovery
Project.
</DIV>

<DIV align="justify" style="font-size: 10pt; margin-top: 10pt"><U><I>Third Quarter Financial Results</I></U>
</DIV>


<DIV align="justify" style="font-size: 10pt; margin-top: 10pt">Transdel reported a net loss of approximately $0.7&nbsp;million, or $0.05 per share, for the quarter
ended September&nbsp;30, 2010, compared to a net loss of approximately $0.9&nbsp;million, or $0.06 per share,
for the same period last year.
</DIV>

<DIV align="justify" style="font-size: 10pt; margin-top: 10pt">Research and development expenses totaled approximately $0.1&nbsp;million and $0.6&nbsp;million for the third
quarter 2010 and 2009, respectively. The decrease in research and development costs compared to
2009 was primarily due to expenses incurred for the Phase 3 clinical study of Ketotransdel<SUP style="font-size: 85%; vertical-align: text-top">&#174;</SUP> that was in progress
during the third quarter 2009.
</DIV>
<P align="center" style="font-size: 10pt">&nbsp;

<P align="center" style="font-size: 10pt"><!-- Folio -->&nbsp;<!-- /Folio -->
</DIV>

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<H5 align="left" style="page-break-before:always">&nbsp;</H5><P>

<DIV style="font-family: 'Times New Roman',Times,serif; margin-left: .25in; width: 7.50in">

<DIV align="justify" style="font-size: 10pt; margin-top: 10pt">General and administrative expenses totaled approximately $0.6&nbsp;million and $0.4&nbsp;million for the
third quarter 2010 and 2009, respectively. The increase was primarily due to stock-based
compensation expenses for investor relations and consulting services provided to the Company.
</DIV>

<DIV align="justify" style="font-size: 10pt; margin-top: 10pt"><U><I>Year-to-Date Financial Results</I></U>
</DIV>


<DIV align="justify" style="font-size: 10pt; margin-top: 10pt">Transdel reported a net loss of approximately $2.1&nbsp;million, or $0.13 per share, for the nine months
ended September&nbsp;30, 2010, compared to a net loss of approximately $3.8&nbsp;million, or $0.24 per share,
for the same period last year.
</DIV>

<DIV align="justify" style="font-size: 10pt; margin-top: 10pt">Research and development expenses totaled approximately $0.3&nbsp;million and $2.6&nbsp;million for the nine
months ended September&nbsp;30, 2010 and 2009, respectively. The decrease in research and development
costs compared to 2009 was primarily due to expenses incurred for the Phase 3 clinical study of
Ketotransdel<SUP style="font-size: 85%; vertical-align: text-top">&#174;</SUP> that was in progress during the first nine months of 2009.
</DIV>

<DIV align="justify" style="font-size: 10pt; margin-top: 10pt">General and administrative expenses totaled approximately $1.8&nbsp;million and $1.2&nbsp;million for the
nine months ended September&nbsp;30, 2010 and 2009, respectively. The increase is primarily due to a
one-time charge of approximately $0.4&nbsp;million for expenses relating to the separation agreement
between the Company and our former chief executive officer who resigned in February&nbsp;2010 and
stock-based compensation expenses for investor relations and consulting services provided to the
Company primarily during the third quarter.
</DIV>

<DIV align="justify" style="font-size: 10pt; margin-top: 10pt"><U><B>About Transdel Pharmaceuticals, Inc.</B></U>
</DIV>


<DIV align="justify" style="font-size: 10pt; margin-top: 10pt">Transdel Pharmaceuticals, Inc. (OTCBB: TDLP) is a specialty pharmaceutical company developing
non-invasive, topically delivered products. The Company&#146;s innovative-patented Transdel&#153; cream
formulation technology is designed to facilitate the effective penetration of a variety of products
through the tough skin barrier. Ketotransdel<SUP style="font-size: 85%; vertical-align: text-top">&#174;</SUP>, the Company&#146;s lead pain product, has successfully
completed a Phase 3 clinical trial and utilizes the Transdel technology to deliver the active drug,
ketoprofen, a non-steroidal anti-inflammatory drug through the skin directly into the underlying
tissues where the drug exerts its well-known anti-inflammatory and analgesic effects. The Company
intends to leverage its Transdel&#153; platform technology to expand and create a portfolio of topical
products for a variety of indications. The Company is actively pursuing partnerships with
companies to expand its product portfolio for pharmaceutical and cosmetic/cosmeceutical products.
For more information, please visit <u>http://www.transdelpharma.com</u>.
</DIV>

<DIV align="justify" style="font-size: 10pt; margin-top: 10pt"><U><B>Safe Harbor Statement</B></U>
</DIV>


<DIV align="justify" style="font-size: 10pt; margin-top: 10pt">The Company cautions you that the statements included in this press release that are not a
description of historical facts are forward-looking statements. These include statements regarding:
the Company&#146;s interpretation of the results of its Phase 3 clinical trial for
Ketotransdel<SUP style="font-size: 85%; vertical-align: text-top">&#174;</SUP>; the Company&#146;s ability to obtain regulatory approval to market
Ketotransdel; and the Company&#146;s ability to continue as a going concern and complete additional
development activities for products utilizing its proprietary transdermal delivery platform. Actual
results may differ materially from those set forth in this press release due to the risks and
uncertainties inherent in the Company&#146;s business, including, without limitation: the FDA may not
agree with the Company&#146;s interpretation of the results from its Phase 3 clinical trial or may
challenge the adequacy of the Company&#146;s clinical trial design or the execution of the clinical
trial; the FDA may require the Company to complete more than one additional clinical trials for
Ketotransdel<SUP style="font-size: 85%; vertical-align: text-top">&#174;</SUP> before the Company can submit a 505(b)(2) NDA application; the results of
any future clinical trials may not be favorable and the Company may never receive regulatory
approval for Ketotransdel<SUP style="font-size: 85%; vertical-align: text-top">&#174;</SUP>; the Company or its license partners may not successfully
launch the proposed anti-cellulite product and the Company&#146;s current need to raise additional funding to
complete its product development plans. More detailed information about the Company and the risk
factors that may affect the realization of forward-looking statements is set forth in the Company&#146;s
filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and
its Quarterly Reports on Form 10-Q filed with the SEC. Such documents may be read free of charge on
the SEC&#146;s web site at <U>www.sec.gov</U>. You are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof. All forward-looking statements
are qualified in their entirety by this cautionary statement and the Company undertakes no
obligation to revise or update this press release to reflect events or circumstances after the date
hereof. This caution is made under the safe harbor provisions of Section&nbsp;21E of the Private
Securities Litigation Reform Act of 1995.
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 10pt">Contact:<BR>
John Lomoro, Chief Financial Officer<BR>
Transdel Pharmaceuticals, Inc.<BR>
858-457-5300<BR>
<u>johnl@transdelpharma.com</u>

</DIV>


<P align="center" style="font-size: 10pt">&nbsp;

<P align="center" style="font-size: 10pt"><!-- Folio -->&nbsp;<!-- /Folio -->
</DIV>




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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
-----END PRIVACY-ENHANCED MESSAGE-----
