<SEC-DOCUMENT>0000950123-24-007586.txt : 20241108
<SEC-HEADER>0000950123-24-007586.hdr.sgml : 20241108
<ACCEPTANCE-DATETIME>20240809112121
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ACCESSION NUMBER:		0000950123-24-007586
CONFORMED SUBMISSION TYPE:	DRSLTR
PUBLIC DOCUMENT COUNT:		2
FILED AS OF DATE:		20240809

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Upstream Bio, Inc.
		CENTRAL INDEX KEY:			0002022626
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		ORGANIZATION NAME:           	03 Life Sciences
		IRS NUMBER:				000000000
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		DRSLTR

	BUSINESS ADDRESS:	
		STREET 1:		890 WINTER STREET, SUITE 200
		CITY:			WALTHAM
		STATE:			MA
		ZIP:			02451
		BUSINESS PHONE:		781-208-2466

	MAIL ADDRESS:	
		STREET 1:		890 WINTER STREET, SUITE 200
		CITY:			WALTHAM
		STATE:			MA
		ZIP:			02451
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<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Goodwin Procter</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">100 Northern Avenue</P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Boston, Massachusetts 02210</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">goodwinlaw.com</P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:10pt; font-family:Times New Roman">+1 617 570 1000</P></TD></TR>
</TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center">August&nbsp;9, 2024 </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Division of Corporation Finance </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Office of Life Sciences </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">United States Securities and Exchange Commission </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">100 F Street,
NE </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Washington, D.C. 20549 </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Attention: Chris Edwards, Jimmy
McNamara, Kevin Kuhar and Franklin Wyman </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="4%" VALIGN="top" ALIGN="left">Re:</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">Upstream Bio, Inc. </P></TD></TR></TABLE>
<P STYLE="margin-top:0pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">Amendment No.&nbsp;1 to Draft Registration Statement on Form <FONT STYLE="white-space:nowrap">S-1</FONT> </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">Submitted July&nbsp;18, 2024 </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">CIK
No.&nbsp;0002022626 </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Dear Ladies and Gentlemen: </P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">This letter is confidentially submitted on behalf of Upstream Bio, Inc. (the &#147;Company&#148;) in response to the comments of the staff of
the Division of Corporation Finance (the &#147;Staff&#148;) of the Securities and Exchange Commission with respect to the Company&#146;s Draft Registration Statement on Form <FONT STYLE="white-space:nowrap">S-1</FONT> originally confidentially
submitted on June&nbsp;12, 2024 and resubmitted on July&nbsp;18, 2024 (the &#147;Draft Registration Statement&#148;), as set forth in your letter dated July&nbsp;25, 2024 addressed to E. Rand Sutherland, Chief Executive Officer of the Company (the
&#147;Comment Letter&#148;). The Company is concurrently confidentially submitting Amendment No.&nbsp;2 to the Draft Registration Statement (the &#147;Amended Draft Registration Statement&#148;), which includes changes that reflect responses to the
Staff&#146;s comments and other updates. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">For reference purposes, the text of the Comment Letter has been reproduced herein with responses
below each numbered comment. For your convenience, we have italicized the reproduced Staff comments from the Comment Letter. Unless otherwise indicated, page references in the descriptions of the Staff&#146;s comments refer to the Draft Registration
Statement, and page references in the responses refer to the Amended Draft Registration Statement. All capitalized terms used and not otherwise defined herein shall have the meanings set forth in the Amended Draft Registration Statement. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">The responses provided herein are based upon information provided to Goodwin Procter&nbsp;LLP by the Company. </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Division of Corporation Finance </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Office of Life Sciences </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">United States Securities and Exchange
Commission </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">August 9, 2024 </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Page 2 </P>
<p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P>
 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>Prospectus Summary</U> </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>Overview, page 1</U> </P> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="4%" VALIGN="top" ALIGN="left">1.</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><I>We note your response to comment 1 and <FONT STYLE="white-space:nowrap">re-issue.</FONT> Please revise to
delete references to verekitug being a <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">&#147;first-in-class</FONT></FONT> antagonist&#148; throughout your registration statement.</I> </P></TD></TR></TABLE>
<P STYLE="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman">RESPONSE: The Company respectfully acknowledges the Staff&#146;s comment and advises the Staff that it has revised the disclosure on
pages&nbsp;1, 6, 28, 95, 118, 123 and 134 to clarify that verekitug is the only known antagonist of the TSLP <I>receptor</I> currently in development. The Company respectfully directs the Staff to its response to Comment&nbsp;4 below which further
explains how verekitug is distinguished from other TSLP-targeting product candidates in clinical development. </P> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="4%" VALIGN="top" ALIGN="left">2.</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><I>Please tell us the basis or source for the statement that </I><I>tezepelumab</I><I> is projected to reach
over $3.0</I><I></I><I>&nbsp;billion in peak global annual sales for severe asthma alone.</I> </P></TD></TR></TABLE> <P STYLE="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman">RESPONSE: The Company
respectfully acknowledges the Staff&#146;s comment and advises the Staff that this statement is supported by a forecast model that was generated by Datamonitor Healthcare in December of 2023. The model was prepared using asthma prevalence and
treatment rates on a <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">country-by-country</FONT></FONT> basis, and in light of certain estimates and assumptions regarding brand penetration, future market events, drug adherence and
dosing. In 2032, tezepelumab is projected to reach a peak of $3.4&nbsp;billion in annual revenue for the treatment of severe asthma in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan. The Company also respectfully
advises the Staff that it has revised the disclosure on pages 1, 118 and 130 to include the year that such sales are projected to be reached in. </P> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="4%" VALIGN="top" ALIGN="left">3.</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><I>We note your response to comment 2 and <FONT STYLE="white-space:nowrap">re-issue.</FONT> Please include the
balancing disclosure in the Overview section that the referenced companies may have significantly greater financial resources and expertise such that they may be more successful than you in obtaining regulatory approvals and achieving widespread
market acceptance.</I> </P></TD></TR></TABLE> <P STYLE="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman">RESPONSE: The Company respectfully acknowledges the Staff&#146;s comment and advises the Staff
that it has revised the disclosure on page 2. </P> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="4%" VALIGN="top" ALIGN="left">4.</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><I>We note your response to comment 6 in which you state that the Company&#146;s due diligence has allowed you
to conclude that &#147;verekitug is the only monoclonal antibody currently in clinical development that targets and inhibits the TSLP receptor&#148;. In light of your due diligence, please tell us why this statement is true given that public records
indicate that Uniquity Bio&#146;s solritug, a monoclonal antibody targeting TSLP, has completed phase 1 trials.</I> </P></TD></TR></TABLE>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center">2 </P>

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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Division of Corporation Finance </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Office of Life Sciences </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">United States Securities and Exchange
Commission </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">August 9, 2024 </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Page 3 </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman">RESPONSE: The Company respectfully acknowledges the Staff&#146;s comment and advises the
Staff that solrikitug, similar to tezepelumab and certain other product candidates currently in clinical development, is a monoclonal antibody targeting the TSLP ligand, not the receptor. This distinction is indicated on pages&nbsp;1, 118, 128 and
150 with respect to tezepelumab. In contrast, verekitug targets and inhibits the TSLP receptor. As such, verekitug is the only monoclonal antibody currently in clinical development that targets and inhibits the TSLP receptor. </P>
<P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="4%" VALIGN="top" ALIGN="left">5.</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><I>We note your response to comment 5 and <FONT STYLE="white-space:nowrap">re-issue</FONT> in part. With
respect to the references to clinical trials conducted by other companies, please disclose whether serious adverse events were observed.</I> </P></TD></TR></TABLE>
<P STYLE="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman">RESPONSE: The Company respectfully acknowledges the Staff&#146;s comment and advises the Staff that it has revised the disclosure on
pages&nbsp;1, 33, 118, 128 and 134. The Company believes that only the safety data for tezepelumab are relevant to an investor&#146;s understanding of the risks associated with verekitug. Tezepelumab is a human monoclonal antibody that binds to the
TSLP ligand and prevents its interaction with the TSLP receptor. While tezepelumab has a different mechanism of action compared to verekitug, which inhibits the TSLP receptor itself, both antibodies work at the same point in the TSLP signaling
pathway. On the other hand, other drugs described in the Amended Draft Registration Statement are similar to verekitug because they are biologics for the same or similar indications, but these drugs do not target the same TSLP pathway, and thus
serious adverse events observed in clinical trials for those drugs are not materially meaningful to investors nor will it inform investors&#146; understanding of verekitug&#146;s safety and tolerability profile. </P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman">The Company respectfully advises the Staff that available safety data for tezepelumab from the Phase 3 clinical trial in severe asthma and
Phase&nbsp;2a proof-of-concept trial in severe COPD both demonstrated that the drug is generally well tolerated, which is discussed on pages&nbsp;1, 118, 128 and 134. In the Phase&nbsp;2 clinical trial of tezepelumab, there were no clinically
meaningful differences in safety results between the tezepelumab and placebo groups. The most frequently reported adverse events were nasopharyngitis, upper respiratory tract infection and headache. Verekitug&#146;s safety profile observed to date
is consistent with that of tezepelumab. As disclosed on page&nbsp;137, the only serious treatment-emergent adverse event the Company has observed with verekitug was in the Phase&nbsp;1 SAD clinical trial where one participant experienced
nephrolithiasis, which was deemed not related to the study drug by the investigator. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>Business </U></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>Ongoing and planned clinical trials, page 145 </U></P> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="4%" VALIGN="top" ALIGN="left">6.</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><I>We note your response to comment 19. Currently the progress arrow representing the indications for severe
asthma and CRSwNP shows that the Phase 2 trials are more than halfway finished, but that patient enrollment is ongoing and has not yet been completed. Please tell us, with a view toward disclosure, why this represents an accurate depiction of the
Phase 2 trials or alternatively, please revise to reduce the length of the progress arrow to accurately reflect the actual status of your pipeline candidate as of the latest practicable date.</I> </P></TD></TR></TABLE>
<P STYLE="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman">RESPONSE: The Company respectfully acknowledges the Staff&#146;s comment and advises the Staff that it has revised the pipeline graphic
appearing on pages&nbsp;2 and 119 to reduce the length of the progress arrows for its Phase 2 clinical trials of verekitug for the treatment of severe asthma and CRSwNP, and include a notation regarding the progress of these trials to date. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>Asset purchase and license agreements </U></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>License
agreement with Lonza, page 151 </U></P> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="4%" VALIGN="top" ALIGN="left">7.</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><I>We note your response to comment 22 and <FONT STYLE="white-space:nowrap">re-issue</FONT> in part. Please
disclose, if true, in the prospectus that the </I><I>Lonza</I><I> agreement is perpetual, or otherwise advise.</I> </P></TD></TR></TABLE>
<P STYLE="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman">RESPONSE: The Company respectfully acknowledges the Staff&#146;s comment and advises the Staff that it has revised the disclosure on
pages&nbsp;98, 154, F-35 and F-59. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">If you should have any questions concerning the enclosed matters, please contact the undersigned at (617) <FONT
STYLE="white-space:nowrap">570-1329.</FONT> </P>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center">3 </P>

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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Division of Corporation Finance </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Office of Life Sciences </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">United States Securities and Exchange
Commission </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">August&nbsp;9, 2024 </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Page 4 </P>
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<TD VALIGN="top">Sincerely,</TD></TR>
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<TD HEIGHT="16"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top"> <P STYLE="margin-top:0pt; margin-bottom:1pt; border-bottom:1px solid #000000; font-size:10pt; font-family:Times New Roman">/s/ Gabriela Morales-Rivera</P></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top">Gabriela Morales-Rivera, Esq.</TD></TR>
</TABLE></DIV> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="4%" VALIGN="top" ALIGN="left">cc:</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">E. Rand Sutherland, M.D., M.P.H., <I>Upstream Bio, Inc.</I> </P></TD></TR></TABLE>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman">Michael Paul Gray, M.B.A., <I>Upstream Bio, Inc.</I> </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman">William D. Collins, Esq., <I>Goodwin Procter LLP</I> </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman">Kathryn W. Clerici, Esq.,<I> Goodwin Procter LLP</I> </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman">Kristin VanderPas, Esq.,<I> Cooley LLP</I> </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman">Dave Peinsipp, Esq.,<I> Cooley LLP</I> </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman">Denny Won, Esq.,<I> Cooley LLP</I> </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman">Charles S. Kim, Esq.,<I> Cooley LLP</I> </P>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center">4 </P>

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