<SEC-DOCUMENT>0001564590-16-025554.txt : 20161003
<SEC-HEADER>0001564590-16-025554.hdr.sgml : 20161003
<ACCEPTANCE-DATETIME>20161003063131
ACCESSION NUMBER:		0001564590-16-025554
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20161003
ITEM INFORMATION:		Other Events
FILED AS OF DATE:		20161003
DATE AS OF CHANGE:		20161003

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			DYNAVAX TECHNOLOGIES CORP
		CENTRAL INDEX KEY:			0001029142
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				330728374
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-34207
		FILM NUMBER:		161914378

	BUSINESS ADDRESS:	
		STREET 1:		2929 SEVENTH STREET
		STREET 2:		SUITE 100
		CITY:			BERKELEY
		STATE:			CA
		ZIP:			94710
		BUSINESS PHONE:		5108485100

	MAIL ADDRESS:	
		STREET 1:		2929 SEVENTH STREET
		STREET 2:		SUITE 100
		CITY:			BERKELEY
		STATE:			CA
		ZIP:			94710
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
<SEQUENCE>1
<FILENAME>dvax-8k_20161003.htm
<DESCRIPTION>8-K
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<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:11pt;">&nbsp;</p>
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<p style="margin-top:0pt;text-align:center;border-top:Solid 1pt;padding-top:1pt;margin-bottom:0pt;text-indent:0%;font-size:4pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&#160;</p>
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;color:#000000;font-size:18pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">UNITED STATES </p>
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;color:#000000;font-size:18pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">SECURITIES AND EXCHANGE COMMISSION<font style="font-weight:normal;"> </font></p>
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;color:#000000;font-size:12pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Washington, D.C. 20549<font style="font-weight:normal;"> </font></p>
<p style="margin-top:6pt;text-align:center;border-bottom:Solid 1pt;padding-bottom:1pt;margin-bottom:0pt;line-height:4pt;margin-left:40%;margin-right:40%;text-indent:0%;font-size:6pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&#160;</p>
<p style="text-align:center;margin-top:12pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;color:#000000;font-size:18pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Form 8-K </p>
<p style="margin-top:6pt;text-align:center;border-bottom:Solid 1pt;padding-bottom:1pt;margin-bottom:0pt;line-height:4pt;margin-left:40%;margin-right:40%;text-indent:0%;font-size:6pt;font-family:Times New Roman;">&nbsp;</p>
<p style="text-align:center;margin-top:12pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;color:#000000;font-size:14pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">CURRENT REPORT<font style="font-weight:normal;"> </font></p>
<p style="text-align:center;margin-top:12pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;color:#000000;font-size:12pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Pursuant to Section 13 or 15(d) of the</p>
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;color:#000000;font-size:12pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Securities Exchange Act of 1934<font style="font-weight:normal;"> </font></p>
<p style="text-align:center;margin-top:12pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;color:#000000;font-size:12pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Date of Report (Date of earliest event reported): &#160;&#160;October 3, 2016 </p>
<p style="margin-top:6pt;text-align:center;border-bottom:Solid 1pt;padding-bottom:1pt;margin-bottom:0pt;line-height:4pt;margin-left:40%;margin-right:40%;text-indent:0%;font-size:6pt;font-family:Times New Roman;">&nbsp;</p>
<p style="text-align:center;margin-top:12pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;color:#000000;font-size:24pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Dynavax Technologies Corporation<font style="font-weight:normal;"> </font></p>
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;color:#000000;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">(Exact name of registrant as specified in its charter)<font style="font-weight:normal;"> </font></p>
<p style="margin-top:6pt;text-align:center;border-bottom:Solid 1pt;padding-bottom:1pt;margin-bottom:0pt;line-height:4pt;margin-left:40%;margin-right:40%;text-indent:0%;font-size:6pt;font-family:Times New Roman;">&nbsp;</p>
<p style="text-align:center;margin-top:12pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;color:#000000;font-size:12pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Commission File Number:&#160;&#160;001-34207<font style="font-weight:normal;"> </font></p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:12pt;">&nbsp;</p>
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<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;color:#000000;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Delaware<font style="font-weight:normal;"> </font></p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&#160;&#160; </p></td>
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<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;color:#000000;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">33-0728374<font style="font-weight:normal;"> </font></p></td>
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<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:-12.25pt;;font-weight:bold;color:#000000;font-size:8pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">(State or other jurisdiction </p>
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:-12.25pt;;font-weight:bold;color:#000000;font-size:8pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">of<font style="font-weight:normal;"> </font>incorporation)</p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-size:8pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&#160;&#160; </p></td>
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<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;color:#000000;font-size:8pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">(IRS Employer<font style="font-weight:normal;"> </font></p>
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;color:#000000;font-size:8pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Identification No.)</p></td>
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<p style="text-align:center;margin-top:12pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;color:#000000;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">2929 Seventh Street, Suite 100</p>
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;color:#000000;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Berkeley, CA 94710-2753<font style="font-weight:normal;"> </font></p>
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;color:#000000;font-size:8pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">(Address of principal executive offices, including zip code)<font style="font-weight:normal;"> </font></p>
<p style="text-align:center;margin-top:12pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;color:#000000;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">(510) 848-5100<font style="font-weight:normal;"> </font></p>
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;color:#000000;font-size:8pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">(Registrant&#8217;s telephone number, including area code)<font style="font-weight:normal;"> </font></p>
<p style="text-align:center;margin-top:12pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;color:#000000;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">(Former name or former address, if changed since last report)<font style="font-weight:normal;"> </font></p>
<p style="margin-top:6pt;text-align:center;border-bottom:Solid 1pt;padding-bottom:1pt;margin-bottom:0pt;line-height:4pt;margin-left:40%;margin-right:40%;text-indent:0%;font-size:6pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&#160;</p>
<p style="margin-top:12pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;color:#000000;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">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>
<p style="margin-top:12pt;margin-bottom:0pt;text-indent:0%;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-family:'Wingdings';"><font style="font-size:10pt;font-family:'Wingdings'">&#168;</font><font style="font-family:Times New Roman;margin-left:36pt;"></font><font style="font-weight:bold;color:#000000;font-family:Times New Roman;">Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)</font></p>
<p style="margin-top:12pt;margin-bottom:0pt;text-indent:0%;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-family:'Wingdings';"><font style="font-size:10pt;font-family:'Wingdings'">&#168;</font><font style="font-family:Times New Roman;margin-left:36pt;"></font><font style="font-weight:bold;color:#000000;font-family:Times New Roman;">Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)</font></p>
<p style="margin-top:12pt;margin-bottom:0pt;text-indent:0%;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-family:'Wingdings';"><font style="font-size:10pt;font-family:'Wingdings'">&#168;</font><font style="font-family:Times New Roman;margin-left:36pt;"></font><font style="font-weight:bold;color:#000000;font-family:Times New Roman;">Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))</font></p>
<p style="margin-top:12pt;margin-bottom:0pt;text-indent:0%;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-family:'Wingdings';"><font style="font-size:10pt;font-family:'Wingdings'">&#168;</font><font style="font-family:Times New Roman;margin-left:36pt;"></font><font style="font-weight:bold;color:#000000;font-family:Times New Roman;">Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) </font></p>
<p style="margin-top:8pt;border-top:Solid 0.75pt #000000;padding-top:0pt;text-align:center;line-height:1pt;margin-bottom:0pt;text-indent:0%;font-size:4pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&#160;</p>
<p style="text-align:center;border-top:Solid 1pt;padding-top:1pt;margin-top:1pt;line-height:1pt;margin-bottom:0pt;text-indent:0%;font-size:4pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&#160;</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:1pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&#160;</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:11pt;">&nbsp;</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:11pt;">&nbsp;</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:12pt;">&nbsp;</p>
<p style="margin-top:12pt;margin-bottom:0pt;text-indent:0%;font-family:Times New Roman;font-size:11pt;">&nbsp;</p>
<hr style="page-break-after:always;width:100%;">
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:11pt;">&nbsp;</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;color:#000000;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;"><a name="_AEIOULastRenderedPageBreakAEIOU2"></a><font style="font-weight:bold;color:#000000;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Item 8</font><font style="font-weight:bold;color:#000000;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">.01.&#160;&#160;&#160;&#160;</font><font style="font-weight:bold;color:#000000;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Other Events</font></p>
<p style="margin-bottom:12pt;margin-top:6pt;text-indent:4.54%;color:#000000;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Dynavax Technologies Corporation ("Dynavax") received anticipated requests for information from the U.S. Food and Drug Administration&#8217;s (&#8220;FDA&#8221;) review team in connection with the pending Biologics License Application (&#8220;BLA&#8221;) for HEPLISAV-B&#8482; [Hepatitis B Vaccine, Recombinant (Adjuvanted)]. The review team&#8217;s questions are in line with the company&#8217;s expectations.&nbsp;&nbsp;</p>
<p style="margin-bottom:12pt;margin-top:0pt;text-indent:4.54%;color:#000000;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The company is working with the FDA to resolve remaining questions regarding the BLA in order to enable the FDA to complete its review by the scheduled Prescription Drug User Fee Act (&#8220;PDUFA&#8221;) action date of December 15, 2016, which remains unchanged. </p>
<p style="margin-bottom:12pt;margin-top:0pt;text-indent:4.54%;color:#000000;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">This report on Form 8-K contains forward-looking statements, including statements regarding interactions with the FDA and the status of the HEPLISAV-B BLA currently under FDA review. These statements are subject to a number of risks and uncertainties that could cause actual results to differ materially, including whether there will be changes that impact the timing of and potential for approval of HEPLISAV-B and whether a determination by the FDA will occur by the scheduled PDUFA date; resolvable issues with respect to questions involving the data or interpretation of the data submitted in support of the BLA; whether the final study results will be deemed satisfactory by the FDA; whether there will be a Vaccines and Related Biological Products Advisory Committee meeting and if so whether it will impact the timing of FDA review or negatively impact the review and approval of the BLA; whether additional studies or manufacturing process enhancements will be required, or other issues will arise that will delay the BLA review or negatively impact the review and approval by the FDA; if approvable, whether the issues will negatively impact the potential scope of the label for HEPLISAV-B; initiation, enrollment and completion of pre-clinical studies and clinical trials of our other product candidates, including SD-101; the results of clinical trials and the impact of those results on the initiation or continuation of subsequent trials and issues arising in the regulatory process; and other risks detailed in the "Risk Factors" section of our most recent current periodic report filed with the SEC. These statements represent our estimates and assumptions only as of the date of this report. We do not undertake any obligation to update publicly any such forward-looking statements, even if new information becomes available.</p>
<p style="margin-top:12pt;margin-bottom:0pt;text-indent:4.54%;font-family:Times New Roman;font-size:11pt;">&nbsp;</p>
<p style="margin-top:12pt;margin-bottom:0pt;text-indent:0%;font-family:Times New Roman;font-size:11pt;">&nbsp;</p>
<hr style="page-break-after:always;width:100%;">
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:11pt;">&nbsp;</p>
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;color:#000000;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;"><a name="_AEIOULastRenderedPageBreakAEIOU3"></a><font style="font-weight:bold;color:#000000;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">SIGNATURES</font><font style="font-weight:normal;"> </font></p>
<p style="margin-top:12pt;margin-bottom:0pt;text-indent:4.54%;color:#000000;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">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 hereunto duly authorized. </p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:12pt;">&nbsp;</p>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&#160; </p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-family:Times New Roman;font-size:11pt;">&nbsp;</p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-family:Times New Roman;font-size:11pt;">&nbsp;</p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-family:Times New Roman;font-size:11pt;">&nbsp;</p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-family:Times New Roman;font-size:11pt;">&nbsp;</p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;color:#000000;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Dynavax Technologies Corporation </p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;color:#000000;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Date: October 3, 2016 </p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-family:Times New Roman;font-size:11pt;">&nbsp;</p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-size:12pt;">&nbsp;</p>
<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;color:#000000;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">By:</p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-family:Times New Roman;font-size:11pt;">&nbsp;</p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;color:#000000;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">/s/ &#160;MICHAEL OSTRACH</p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-family:Times New Roman;font-size:11pt;">&nbsp;</p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;color:#000000;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Michael Ostrach</p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-family:Times New Roman;font-size:11pt;">&nbsp;</p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-family:Times New Roman;font-size:11pt;">&nbsp;</p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-family:Times New Roman;font-size:11pt;">&nbsp;</p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-family:Times New Roman;font-size:11pt;">&nbsp;</p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;color:#000000;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Senior Vice President</p></td>
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