<SEC-DOCUMENT>0001193125-17-342558.txt : 20171114
<SEC-HEADER>0001193125-17-342558.hdr.sgml : 20171114
<ACCEPTANCE-DATETIME>20171114160925
ACCESSION NUMBER:		0001193125-17-342558
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20171108
ITEM INFORMATION:		Entry into a Material Definitive Agreement
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20171114
DATE AS OF CHANGE:		20171114

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:		171201559

	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>d494864d8k.htm
<DESCRIPTION>FORM 8-K
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<HTML><HEAD>
<TITLE>Form 8-K</TITLE>
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 <P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:0pt;border-bottom:1px solid #000000">&nbsp;</P>
<P STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</P> <P STYLE="margin-top:4pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>UNITED STATES </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>SECURITIES AND EXCHANGE COMMISSION </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>Washington, D.C. 20549 </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>Form <FONT
STYLE="white-space:nowrap">8-K</FONT> </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>CURRENT
REPORT </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>Pursuant to Section&nbsp;13 or 15(d) </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>of the Securities Exchange Act of 1934 </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>Date of Report (Date of earliest event reported): November 8, 2017 </B></P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center> <P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:24pt; font-family:Times New Roman" ALIGN="center"><B>Dynavax Technologies Corporation </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>(Exact name of registrant as specified in its charter) </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Commission
File <FONT STYLE="white-space:nowrap">Number:&nbsp;001-34207</FONT> </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="top" ALIGN="center"><B>Delaware</B></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" ALIGN="center"><B><FONT STYLE="white-space:nowrap">33-0728374</FONT></B></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:8pt">
<TD VALIGN="top" ALIGN="center"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(State or other jurisdiction</B></P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>of incorporation)</B></P></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" ALIGN="center"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(IRS Employer</B></P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>Identification No.)</B></P></TD></TR>
</TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>2929 Seventh Street, Suite 100 </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Berkeley, CA 94710-2753 </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(Address of principal executive offices, including zip code) </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>(510) <FONT STYLE="white-space:nowrap">848-5100</FONT> </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(Registrant&#146;s telephone number, including area code) </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(Former name or former address, if changed since last report) </B></P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center> <P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Check the appropriate box below if the Form <FONT STYLE="white-space:nowrap">8-K</FONT> filing is intended to simultaneously satisfy the filing obligation
of the registrant under any of the following provisions: </B></P> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left"><B></B>&#9744;<B></B><B></B></TD>
<TD ALIGN="left" VALIGN="top"><B>Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) </B></TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left"><B></B>&#9744;<B></B><B></B></TD>
<TD ALIGN="left" VALIGN="top"><B>Soliciting material pursuant to Rule <FONT STYLE="white-space:nowrap">14a-12</FONT> under the Exchange Act (17 CFR <FONT STYLE="white-space:nowrap">240.14a-12)</FONT> </B></TD></TR></TABLE>
<P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left"><B></B>&#9744;<B></B><B></B></TD>
<TD ALIGN="left" VALIGN="top"><B><FONT STYLE="white-space:nowrap">Pre-commencement</FONT> communications pursuant to Rule <FONT STYLE="white-space:nowrap">14d-2(b)</FONT> under the Exchange Act (17 CFR
<FONT STYLE="white-space:nowrap">240.14d-2(b))</FONT> </B></TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left"><B></B>&#9744;<B></B><B></B></TD>
<TD ALIGN="left" VALIGN="top"><B><FONT STYLE="white-space:nowrap">Pre-commencement</FONT> communications pursuant to Rule <FONT STYLE="white-space:nowrap">13e-4(c)</FONT> under the Exchange Act (17 CFR
<FONT STYLE="white-space:nowrap">240.13e-4(c))</FONT> </B></TD></TR></TABLE> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Indicate by check mark whether the Registrant is an emerging growth company as
defined in Rule 405 of the Securities Act of 1933 (&#167;230.405 of this chapter) or Rule <FONT STYLE="white-space:nowrap">12b-2</FONT> of the Securities Exchange Act of 1934 <FONT STYLE="white-space:nowrap">(&#167;240.12b-2</FONT> of this chapter).
</B></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Emerging growth company&nbsp;&nbsp;</B>&#9744;<B></B><B> </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>If an emerging growth company, indicate by check mark if the Registrant has elected not to use the extended transition period for complying with any new or
revised financial accounting standards provided pursuant to Section&nbsp;13(a) of the Exchange Act.&nbsp;&nbsp;</B>&#9744;<B></B><B> </B></P> <P STYLE="font-size:10pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:0pt;border-bottom:1px solid #000000">&nbsp;</P> <P STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</P>

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<TD WIDTH="9%" VALIGN="top" ALIGN="left"><B>Item&nbsp;1.01.</B></TD>
<TD ALIGN="left" VALIGN="top"><B>Entry into a Material Definitive Agreement </B></TD></TR></TABLE> <P STYLE="margin-top:6pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">On November&nbsp;8, 2017, Dynavax
Technologies Corporation (the &#147;Company&#148;) and inVentiv Commercial Services, LLC (&#147;inVentiv,&#148; and together with the Company, the &#147;Parties&#148;) entered into a project agreement (the &#147;Project Agreement&#148;) pursuant to
that certain Master Services Agreement, by and between the Parties, dated as of January&nbsp;11, 2016 (the &#147;MSA&#148;). Pursuant to the Project Agreement, inVentiv will provide a field force of account managers to provide certain detailing
services, sales operation services, compliance services and training services with respect to <FONT STYLE="white-space:nowrap">HEPLISAV-B</FONT> to the Company in exchange for an <FONT STYLE="white-space:nowrap">up-front</FONT> implementation fee
and a fixed annual fee. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">The Project Agreement terminates automatically on the second anniversary of the date of the first activity
undertaken by inVentiv to detail <FONT STYLE="white-space:nowrap">HEPLISAV-B</FONT> (the &#147;Deployment Date&#148;) unless earlier extended upon the mutual written agreement of the Parties. The Company may terminate the Project Agreement for any
reason upon timely notice; provided, however, that if the Company terminates the Project Agreement prior to the first anniversary of the Deployment Date, the Company will be obligated to pay inVentiv a termination fee, the amount of which varies
depending on the date of termination. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">The foregoing summary of the Project Agreement is not complete and is qualified in its entirety by
reference to the Project Agreement and the MSA, which will be filed as exhibits to the Company&#146;s Annual Report on Form <FONT STYLE="white-space:nowrap">10-K</FONT> for the year ending December&nbsp;31, 2017. Certain terms of the Project
Agreement have been omitted from this Form <FONT STYLE="white-space:nowrap">8-K</FONT> and will be omitted from the version to be filed as an exhibit to the Form <FONT STYLE="white-space:nowrap">10-K</FONT> pursuant to a Confidential Treatment
Request that the Company plans to submit to the Securities and Exchange Commission at the time of the filing of the Form <FONT STYLE="white-space:nowrap">10-K.</FONT> </P> <P STYLE="font-size:18pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
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<TD WIDTH="9%" VALIGN="top" ALIGN="left"><B>Item&nbsp;8.01.</B></TD>
<TD ALIGN="left" VALIGN="top"><B>Other Events </B></TD></TR></TABLE> <P STYLE="margin-top:6pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">On November&nbsp;9, 2017, the Company issued a press release titled
&#147;Dynavax Announces FDA Approval of <FONT STYLE="white-space:nowrap">HEPLISAV-B</FONT><SUP STYLE="font-size:85%; vertical-align:top">TM</SUP> for Prevention of Hepatitis B in Adults&#148;. A copy of the press release is attached as Exhibit 99.1
to this current report and is incorporated herein by reference. </P> <P STYLE="font-size:18pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
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<TD WIDTH="9%" VALIGN="top" ALIGN="left"><B>Item&nbsp;9.01.</B></TD>
<TD ALIGN="left" VALIGN="top"><B>Financial Statements and Exhibits </B></TD></TR></TABLE> <P STYLE="margin-top:6pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">(d) Exhibits. The following exhibit is filed
herewith: </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="top" NOWRAP>99.1</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"><A HREF="d494864dex991.htm">Press Release, dated November&nbsp;
9, 2017, titled &#147;Dynavax Announces FDA Approval of <FONT STYLE="white-space:nowrap">HEPLISAV-B</FONT><SUP STYLE="font-size:85%; vertical-align:top">TM</SUP> for Prevention of Hepatitis B in Adults</A>&#148;</TD></TR>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>SIGNATURES </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">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="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="top" COLSPAN="3">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Dynavax Technologies Corporation</TD></TR></TABLE>
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<TD VALIGN="top">Date: November&nbsp;14, 2017</TD>
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<TD VALIGN="top">By:</TD>
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<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/ STEVEN N. GERSTEN</P></TD></TR>
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<TD VALIGN="top">Steven N. Gersten</TD></TR>
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<TD VALIGN="bottom">Vice President, General Counsel and Chief Ethics and Compliance Officer</TD></TR>
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<TYPE>EX-99.1
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<DESCRIPTION>EX-99.1
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<HTML><HEAD>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="right"><B>Exhibit 99.1 </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<IMG SRC="g494864snap0004.jpg" ALT="LOGO">
 </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Dynavax Announces FDA Approval of <FONT STYLE="white-space:nowrap">HEPLISAV-B&#153;</FONT> </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>for Prevention of Hepatitis B in Adults </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><I>&#151; First and Only <FONT STYLE="white-space:nowrap">Two-Dose</FONT> Vaccine in United States for Prevention of Hepatitis B in Adults
&#151; </I></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><I>&#151; First New Hepatitis B Vaccine in United States in More than 25 Years &#151; </I></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><I>&#151; Company to Host Conference Call/Webcast Today at 5:00 p.m. ET &#151; </I></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>BERKELEY, Calif. &#150; 11/09/17 &#150;</B> Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that the U.S. Food and Drug Administration
(FDA) has approved <FONT STYLE="white-space:nowrap">HEPLISAV-B</FONT> [Hepatitis B Vaccine, Recombinant (Adjuvanted)] for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. <FONT
STYLE="white-space:nowrap">HEPLISAV-B</FONT> is the first new hepatitis B vaccine in the United States in more than 25 years and the only <FONT STYLE="white-space:nowrap">two-dose</FONT> hepatitis B vaccine for adults. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Hepatitis B is an extremely infectious and potentially deadly virus affecting a wide range of adults in the United States. There is no cure for hepatitis B,
and infections are on the rise. In 2015, new cases of acute hepatitis B increased by more than 20&nbsp;percent nationally.<SUP STYLE="font-size:85%; vertical-align:top">i</SUP> Hepatitis B can be prevented through effective vaccination. Current
hepatitis B vaccines require three shots over a <FONT STYLE="white-space:nowrap">six-month</FONT> period, however, almost half of adults fail to complete the series within one year.<SUP STYLE="font-size:85%; vertical-align:top">ii</SUP> </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">&#147;Prevention of hepatitis B in adults through vaccination is more important than ever given the increase in the rate of infections,&#148; said William
Schaffner, M.D., professor of Preventive Medicine, Vanderbilt University Medical Center. &#147;Too many <FONT STYLE="white-space:nowrap">at-risk</FONT> adults remain unprotected against this virus. A <FONT STYLE="white-space:nowrap">two-dose</FONT>
schedule with higher rates of protection, along with other strategies, may help us move closer to the goal of eliminating hepatitis B as a public health problem in the United States.&#148; </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The approval of <FONT STYLE="white-space:nowrap">HEPLISAV-B</FONT> was based on data from three Phase 3
<FONT STYLE="white-space:nowrap">non-inferiority</FONT> trials of nearly 10,000 adult participants who received <FONT STYLE="white-space:nowrap">HEPLISAV-B.</FONT> The pivotal studies compared <FONT STYLE="white-space:nowrap">HEPLISAV-B</FONT>
administered in two doses over one month to Engerix-B administered in three doses over a <FONT STYLE="white-space:nowrap">six-month</FONT> schedule. Results from the largest Phase 3 trial, which included 6,665 participants, showed that <FONT
STYLE="white-space:nowrap">HEPLISAV-B</FONT> demonstrated a statistically significantly higher rate of protection of 95% compared with 81% for Engerix-B. In a subgroup analysis of 961 participants with Type 2 diabetes,
<FONT STYLE="white-space:nowrap">HEPLISAV-B</FONT> demonstrated a statistically significantly higher rate of protection of 90% compared to 65% for Engerix-B. Across the three clinical trials, the most common local reaction was injection site pain
(23% to 39%). The most common systemic reactions were fatigue (11% to 17%) and headache (8% to 17%). </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT STYLE="white-space:nowrap">&#147;HEPLISAV-B</FONT> is the first <FONT STYLE="white-space:nowrap">FDA-approved</FONT> product for Dynavax and
demonstrates our ability to develop innovative products and progress them from discovery to commercialization,&#148; said Eddie Gray, chief executive officer of Dynavax. &#147;We would like to thank the many study participants and clinical trial
investigators who contributed to the development of <FONT STYLE="white-space:nowrap">HEPLISAV-B.</FONT> We expect that it will become an essential tool in the public health community&#146;s fight to prevent hepatitis B, and we look forward to making
<FONT STYLE="white-space:nowrap">HEPLISAV-B</FONT> available to clinicians and their adult patients.&#148; </P>

<p Style='page-break-before:always'>
<HR  SIZE="3" style="COLOR:#999999" WIDTH="100%" ALIGN="CENTER">
 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Dynavax expects to commercially launch <FONT STYLE="white-space:nowrap">HEPLISAV-B</FONT> in the United States in
the first quarter of 2018. In preparation for launch, Dynavax has been building commercial infrastructure and optimizing manufacturing processes to meet anticipated demand. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Conference Call Details </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The Dynavax management team will
host a conference call and webcast today, Thursday, November&nbsp;9, 2017 at 5:00 p.m. Eastern Time, to provide more information about the FDA approval of <FONT STYLE="white-space:nowrap">HEPLISAV-B.</FONT> The live call can be accessed by phone by
dialing (877) <FONT STYLE="white-space:nowrap">479-1857</FONT> from the U.S. and Canada or +1 (503) <FONT STYLE="white-space:nowrap">343-6309</FONT> internationally and using the passcode 5357789. The live call is being webcast and can be accessed
in the &#147;Investors and Media&#148; section of the Company&#146;s website at <U>www.dynavax.com</U>. A replay of the webcast will be available for 30 days following the live event. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>About Hepatitis B </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Hepatitis B is a viral disease of the
liver that can become chronic and lead to cirrhosis, liver cancer and death. The hepatitis B virus is 50 to 100 times more infectious than HIV,<SUP STYLE="font-size:85%; vertical-align:top">iii</SUP> and transmission is on the rise. There is no cure
for hepatitis B, but effective vaccination can prevent the disease. In adults, hepatitis B is spread through contact with infected blood and through unprotected sex with an infected person. The CDC recommends vaccination for those at high risk for
infection due to their jobs, lifestyle, living situations and travel to certain areas.<SUP STYLE="font-size:85%; vertical-align:top">iv</SUP> Because people with diabetes are particularly vulnerable to infection, the CDC recommends vaccination for
adults age 19 to 59 with diabetes as soon as possible after their diagnosis, and for people age 60 and older with diabetes at their physician&#146;s discretion.<SUP STYLE="font-size:85%; vertical-align:top">v</SUP> Approximately 20&nbsp;million U.S.
adults have diabetes, and 1.5&nbsp;million new cases of diabetes are diagnosed each year.<SUP STYLE="font-size:85%; vertical-align:top">vi</SUP> </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>About
<FONT STYLE="white-space:nowrap">HEPLISAV-B</FONT> </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT STYLE="white-space:nowrap">HEPLISAV-B</FONT> is an adult hepatitis B vaccine that combines
hepatitis B surface antigen with Dynavax&#146;s proprietary Toll-like Receptor (TLR) 9 agonist to enhance the immune response. Dynavax has worldwide commercial rights to <FONT STYLE="white-space:nowrap">HEPLISAV-B.</FONT> </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Indication and Use </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><FONT STYLE="white-space:nowrap">HEPLISAV-B</FONT> is indicated for active immunization against infection caused by all known subtypes of hepatitis B virus. <FONT
STYLE="white-space:nowrap">HEPLISAV-B</FONT> is approved for use in adults 18 years of age and older. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Important Safety Information (ISI) </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Do not administer <FONT STYLE="white-space:nowrap">HEPLISAV-B</FONT> to individuals with a history of severe allergic reaction (e.g., anaphylaxis) after a
previous dose of any hepatitis B vaccine or to any component of <FONT STYLE="white-space:nowrap">HEPLISAV-B,</FONT> including yeast. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Appropriate medical
treatment and supervision must be available to manage possible anaphylactic reactions following administration of <FONT STYLE="white-space:nowrap">HEPLISAV-B.</FONT> </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to
<FONT STYLE="white-space:nowrap">HEPLISAV-B.</FONT> </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Hepatitis B has a long incubation period. <FONT STYLE="white-space:nowrap">HEPLISAV-B</FONT> may not
prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The most common
patient reported adverse reactions reported within 7 days of vaccination were injection site pain (23% to 39%), fatigue (11% to 17%) and headache (8% to 17%). </P>

<p Style='page-break-before:always'>
<HR  SIZE="3" style="COLOR:#999999" WIDTH="100%" ALIGN="CENTER">
 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">For full Prescribing Information for <FONT STYLE="white-space:nowrap">HEPLISAV-B,</FONT> <U>click here</U>. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>About Dynavax </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Dynavax is a commercial-stage
biopharmaceutical company focused on leveraging the power of the body&#146;s innate and adaptive immune responses through toll-like receptor (TLR) stimulation. Dynavax discovers and develops novel vaccines and immuno-oncology therapeutics. The
Company&#146;s first commercial product, <FONT STYLE="white-space:nowrap">HEPLISAV-B,</FONT> a hepatitis B vaccine for adults, is approved in the United States. Dynavax&#146;s lead immunotherapy product,
<FONT STYLE="white-space:nowrap">SD-101,</FONT> is an investigational cancer immunotherapeutic currently being evaluated in Phase 1/2 studies and its second cancer immunotherapeutic, DV281, is in Phase 1 development. For more information, visit
<U>www.dynavax.com</U>. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Forward-Looking Statements </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">This press release contains forward-looking statements, including statements regarding the commercial launch and manufacturing of <FONT
STYLE="white-space:nowrap">HEPLISAV-B.</FONT> These statements are subject to a number of risks and uncertainties that could cause actual results to differ materially, including whether the company will be able to build the commercial infrastructure
required to launch <FONT STYLE="white-space:nowrap">HEPLISAV-B;</FONT> whether we will launch <FONT STYLE="white-space:nowrap">HEPLISAV-B</FONT> in the first quarter of 2018; whether we will be able to ramp up manufacturing activities to meet demand
for <FONT STYLE="white-space:nowrap">HEPLISAV-B;</FONT> whether the CDC&#146;s Advisory Committee on Immunization Practices (ACIP) will add <FONT STYLE="white-space:nowrap">HEPLISAV-B</FONT> to its adult vaccination schedule during its February 2018
meeting, or at all; whether potential claims against us, including those based on patent rights of others, will result in an injunction against sales or otherwise impact commercialization and sales; and the results of clinical studies of
Dynavax&#146;s product candidates, such as <FONT STYLE="white-space:nowrap">SD-101,</FONT> and the impact of those results on the initiation or continuation of subsequent studies for those product candidates, and issues arising in the regulatory
process; and other risks detailed in the &#147;Risk Factors&#148; 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 press release. We do not
undertake any obligation to update publicly any such forward-looking statements, even if new information becomes available. Information on Dynavax&#146;s website at <U>www.dynavax.com</U> is not incorporated by reference in our current periodic
reports with the SEC. </P> <P STYLE="margin-top:24pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"># # # </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Contact:
</B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Ryan Spencer </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">VP, Corporate Strategy&nbsp;&amp;
Communications </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">510.665.4618 </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>rspencer@dynavax.com</U>
</P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Media Contact: </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Rachel St. Martin </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">WCG </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">646.894.5757 </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>rstmartin@w2ogroup.com</U> </P> <P STYLE="line-height:8.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000;width:10%">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left"><SUP STYLE="font-size:85%; vertical-align:top">i</SUP>&nbsp;</TD>
<TD ALIGN="left" VALIGN="top">CDC. <U><FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">https://www.cdc.gov/hepatitis/statistics/2015surveillance/index.htm#tabs-5-8</FONT></FONT></U>. Fig 3.2 </TD></TR></TABLE>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left"><SUP STYLE="font-size:85%; vertical-align:top">ii</SUP>&nbsp;</TD>
<TD ALIGN="left" VALIGN="top">Nelson J, et al. Compliance with multiple-dose vaccine schedules among older children, adolescents and adults: results from a Vaccine Safety Datalink Study. <I>American Journal of Public Health.</I> 2009;99:S2.
</TD></TR></TABLE>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left"><SUP STYLE="font-size:85%; vertical-align:top">iii</SUP>&nbsp;</TD>
<TD ALIGN="left" VALIGN="top">CDC. <U>https://www.cdc.gov/hepatitis/hbv/bfaq.htm</U>. </TD></TR></TABLE>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left"><SUP STYLE="font-size:85%; vertical-align:top">iv</SUP>&nbsp;</TD>
<TD ALIGN="left" VALIGN="top">CDC. <U>https://www.cdc.gov/hepatitis/hbv/hbvfaq.htm</U>. </TD></TR></TABLE>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left"><SUP STYLE="font-size:85%; vertical-align:top">v</SUP>&nbsp;</TD>
<TD ALIGN="left" VALIGN="top">CDC. <U>https://www.cdc.gov/diabetes/pubs/pdf/hepb_vaccination.pdf</U>. </TD></TR></TABLE>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left"><SUP STYLE="font-size:85%; vertical-align:top">vi</SUP>&nbsp;</TD>
<TD ALIGN="left" VALIGN="top">CDC. <U>https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf</U>. </TD></TR></TABLE>
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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
