<SEC-DOCUMENT>0001367644-16-000076.txt : 20160930
<SEC-HEADER>0001367644-16-000076.hdr.sgml : 20160930
<ACCEPTANCE-DATETIME>20160930092124
ACCESSION NUMBER:		0001367644-16-000076
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20160929
ITEM INFORMATION:		Entry into a Material Definitive Agreement
ITEM INFORMATION:		Regulation FD Disclosure
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20160930
DATE AS OF CHANGE:		20160930

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Emergent BioSolutions Inc.
		CENTRAL INDEX KEY:			0001367644
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				141902018
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-33137
		FILM NUMBER:		161911422

	BUSINESS ADDRESS:	
		STREET 1:		400 PROFESSIONAL DR, SUITE 400
		CITY:			GAITHERSBURG
		STATE:			MD
		ZIP:			20879
		BUSINESS PHONE:		240-631-3200

	MAIL ADDRESS:	
		STREET 1:		400 PROFESSIONAL DR, SUITE 400
		CITY:			GAITHERSBURG
		STATE:			MD
		ZIP:			20879
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<div style="FONT-SIZE: 14pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: bold; TEXT-ALIGN: center; LINE-HEIGHT: 15.95pt">UNITED STATES</div>

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</font> WASHINGTON, D.C. 20549</div>

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<div style="FONT-SIZE: 18pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: bold; TEXT-ALIGN: center; LINE-HEIGHT: 20.5pt">FORM 8-K</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: bold; TEXT-ALIGN: center; LINE-HEIGHT: 11.4pt">CURRENT REPORT<font style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif"><br>
</font> Pursuant to Section 13 or 15(d) of the</div>

<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: bold; TEXT-ALIGN: center; LINE-HEIGHT: 11.4pt">Securities Exchange Act of 1934</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: center; LINE-HEIGHT: 11.4pt">Date of report (Date of earliest event reported):&#160;<font style="FONT-WEIGHT: bold">&#160;September 30, 2016</font></div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: bold; TEXT-ALIGN: center; LINE-HEIGHT: 11.4pt">EMERGENT BIOSOLUTIONS INC.<font style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif"><br>
</font><font style="FONT-WEIGHT: normal">(Exact Name of Registrant as Specified in Charter)</font></div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: center; LINE-HEIGHT: 11.4pt">(State or Other Jurisdiction</div>

<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: center; LINE-HEIGHT: 11.4pt">of Incorporation)</div>
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</font> File Number)</div>
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</font> Identification No.)</div>
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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: bold; TEXT-ALIGN: center; LINE-HEIGHT: 11.4pt">400 Professional Drive, Suite 400,</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: center; LINE-HEIGHT: 11.4pt">(Address of Principal Executive Offices)</div>
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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: bold; TEXT-ALIGN: center; LINE-HEIGHT: 11.4pt">Not applicable</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: center; LINE-HEIGHT: 11.4pt">(Former Name or Former Address, if Changed Since Last Report)</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left; LINE-HEIGHT: 11.4pt; TEXT-INDENT: 36pt">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 (see General Instruction A.2. below):</div>

<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left; LINE-HEIGHT: 11.4pt; TEXT-INDENT: 36pt">&#160;</div>

<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left; LINE-HEIGHT: 11.4pt; TEXT-INDENT: 36pt">[&#160; ] Written communications pursuant to Rule&#160;425 under the Securities Act (17 CFR 230.425)</div>

<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left; LINE-HEIGHT: 11.4pt; TEXT-INDENT: 36pt">[&#160; ] Soliciting material pursuant to Rule&#160;14a-12 under the Exchange Act (17 CFR 240.14a-12)</div>

<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left; LINE-HEIGHT: 11.4pt; TEXT-INDENT: 36pt">[&#160; ] Pre-commencement communications pursuant to Rule&#160;14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))</div>

<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left; LINE-HEIGHT: 11.4pt; TEXT-INDENT: 36pt">[&#160; ] Pre-commencement communications pursuant to Rule&#160;13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: bold; TEXT-ALIGN: left; LINE-HEIGHT: 13.7pt">Item&#160;1.01 Entry into a Material Definitive Agreement.</div>

<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left; LINE-HEIGHT: 13.7pt">&#160;</div>

<div style="MARGIN-BOTTOM: 12pt; FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: normal; TEXT-ALIGN: left; LINE-HEIGHT: 13.7pt; TEXT-INDENT: 36pt">On September 30, 2016, Emergent Product Development Gaithersburg Inc., a wholly-owned subsidiary of Emergent BioSolutions Inc., entered into a contract with the U.S. Department of Health and Human Services, through the Biomedical Advanced Research and Development Authority (BARDA), for the advanced development and delivery of NuThrax<sup style="vertical-align: text-top; line-height: 1; font-size: smaller">TM</sup> (anthrax vaccine adsorbed with CPG 7909 adjuvant), also known as AV7909, the company's next generation anthrax vaccine candidate.</div>

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<div style="MARGIN-BOTTOM: 12pt; FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: normal; TEXT-ALIGN: left; LINE-HEIGHT: 13.7pt; TEXT-INDENT: 36pt">Under the terms of the contract, activities to be completed under the base period of performance include licensure-enabling non-clinical and clinical studies, the manufacture and delivery of initial doses to the SNS, and submission of a Biologics License Application to the FDA with an expected FDA-licensure under the Animal Rule.</div>

<div style="MARGIN-BOTTOM: 12pt; FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: normal; TEXT-ALIGN: left; LINE-HEIGHT: 13.7pt; TEXT-INDENT: 36pt">The contract contains a number of terms and conditions that are customary for government contracts of this nature, including provisions giving the government the right to terminate the contract at any time for its convenience for any reason or no reason, to order the company to suspend all or any part of the work under the contract at the government's discretion or to audit and object to any contract-related costs on the grounds that they are not allowable under the Federal Acquisition Regulation and require the company to reimburse all such costs.</div>

<div style="MARGIN-BOTTOM: 12pt; FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: normal; TEXT-ALIGN: left; LINE-HEIGHT: 13.7pt; TEXT-INDENT: 36pt">The foregoing summary of the contract does not purport to be complete and is qualified in its entirety by reference to the actual contract, a copy of which will be filed as an exhibit to the company's Quarterly Report on Form 10-Q for the quarter ended September&#160;30, 2016.</div>

<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: bold; TEXT-ALIGN: left; LINE-HEIGHT: 13.7pt">Item&#160;7.01 Regulation FD Disclosure.</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: normal; TEXT-ALIGN: left; LINE-HEIGHT: 13.7pt; TEXT-INDENT: 36pt">On September 30, 2016, the company issued a press release announcing that it had entered into a contract for the advanced development and delivery of NuThrax, the company's next generation anthrax vaccine candidate. A copy of the press release announcing the contract is attached hereto as Exhibit 99 and is incorporated herein by reference.</div>

<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left; LINE-HEIGHT: 13.7pt">&#160;</div>

<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: bold; TEXT-ALIGN: left; LINE-HEIGHT: 13.7pt">Forward-Looking Statements</div>

<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: bold; TEXT-ALIGN: left; LINE-HEIGHT: 13.7pt">&#160;</div>

<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: normal; FONT-STYLE: italic; TEXT-ALIGN: left; LINE-HEIGHT: 13.7pt; TEXT-INDENT: 36pt">This Current Report on Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding the total potential realizable value of the contract, the anticipated timing of EUA eligibility, our strategy, future operations, prospects, plans and objectives with respect to NuThrax, and any other statements containing the words "believes," "expects," "anticipates," "intends," "plans," "estimates" and similar expressions, are forward-looking statements. These forward-looking statements are based on our current intentions, beliefs and expectations regarding future events. We cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date hereof, and, except as required by law, we do not undertake to update any forward-looking statement to reflect new information, events or circumstances.</div>

<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: normal; FONT-STYLE: italic; TEXT-ALIGN: left; LINE-HEIGHT: 13.7pt">&#160;</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: bold; TEXT-ALIGN: left; LINE-HEIGHT: 13.7pt">&#160;</div>

<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: bold; TEXT-ALIGN: left; LINE-HEIGHT: 13.7pt">Item&#160;9.01 Financial Statements and Exhibits.</div>

<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left; MARGIN-TOP: 6pt; LINE-HEIGHT: 13.7pt">(d) Exhibits</div>

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<div style="FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: bold; TEXT-ALIGN: center; LINE-HEIGHT: 13.7pt; TEXT-INDENT: 9pt"><u>Exhibit&#160;No.</u></div>
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<div style="FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: bold; TEXT-ALIGN: left; LINE-HEIGHT: 13.7pt"><u>Description</u></div>
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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left; MARGIN-LEFT: 18pt; LINE-HEIGHT: 13.7pt; TEXT-INDENT: -18pt">99</div>
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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left; LINE-HEIGHT: 13.7pt">Press Release dated September 30, 2016.</div>
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<div style="MARGIN-BOTTOM: 12pt; FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left; MARGIN-TOP: 3pt; LINE-HEIGHT: 11.4pt">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.</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left; LINE-HEIGHT: 11.4pt">Date:&#160;&#160;September 30, 2016</div>
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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left; LINE-HEIGHT: 11.4pt">EMERGENT BIOSOLUTIONS INC.</div>
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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left; LINE-HEIGHT: 11.4pt">By:</div>
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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left; LINE-HEIGHT: 11.4pt">/<font style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif"><u>s/&#160;ROBERT&#160;G. KRAMER&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;</u></font>&#160;</div>

<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left; LINE-HEIGHT: 11.4pt">Robert G. Kramer</div>

<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left; LINE-HEIGHT: 12.55pt">Executive Vice President and Chief Financial Officer</div>
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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: bold; TEXT-ALIGN: left; LINE-HEIGHT: 11.4pt; MARGIN-RIGHT: 18pt">EMERGENT BIOSOLUTIONS AWARDED BARDA CONTRACT FOR ADVANCED DEVELOPMENT AND DELIVERY OF NUTHRAX, A NEXT GENERATION ANTHRAX VACCINE, VALUED AT UP TO $1.6 BILLION</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left; LINE-HEIGHT: 11.4pt; MARGIN-RIGHT: 18pt"><font style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: bold">GAITHERSBURG, Md., September 30, 2016</font>&#8212;Emergent BioSolutions Inc. (NYSE: EBS) announced today that it has signed a multi-year contract with the Biomedical Advanced Research and Development Authority (BARDA), which is a division of the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response, for the advanced development and delivery of NuThrax<sup style="vertical-align: text-top; line-height: 1; font-size: smaller">TM</sup> (anthrax vaccine adsorbed with CPG 7909 adjuvant), also known as AV7909, the company's next generation anthrax vaccine candidate. The contract, valued at up to approximately $1.6 billion, consists of a five-year base period of performance valued at approximately $200 million to develop NuThrax for post-exposure prophylaxis of anthrax disease and to deliver to the Strategic National Stockpile (SNS) an initial two million doses following Emergency Use Authorization (EUA) pre-approval by the U.S. Food and Drug Administration (FDA). The company anticipates that FDA could authorize NuThrax for emergency use as early as 2018, triggering deliveries of NuThrax to the SNS in 2019. The contract also includes procurement options for the delivery of an additional 7.5 million to 50 million doses of NuThrax to the SNS, valued from approximately $255 million to up to $1.4 billion, respectively, and options for an additional clinical study and post-marketing commitments valued at $48 million, which if both were to be exercised in full, would increase the total contract value to up to $1.6 billion.</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left; LINE-HEIGHT: 11.4pt; MARGIN-RIGHT: 18pt">"Emergent is pleased that BARDA has selected NuThrax to address the U.S. government's desire for a next generation anthrax vaccine with an enhanced product profile that includes requiring fewer doses and eliciting a faster immune response," said Daniel J. Abdun-Nabi, president and chief executive officer of Emergent BioSolutions. "We look forward to collaborating with BARDA to further develop NuThrax towards an EUA-eligible product for the SNS and subsequently towards FDA licensure."</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left; LINE-HEIGHT: 11.4pt; MARGIN-RIGHT: 18pt">Under the terms of the contract, activities to be completed under the base period of performance include licensure-enabling non-clinical and clinical studies, the manufacture and delivery of initial doses to the SNS, and submission of a Biologics License Application to the FDA with an expected FDA-licensure under the Animal Rule.</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left; LINE-HEIGHT: 11.4pt; MARGIN-RIGHT: 18pt">NuThrax is comprised of BioThrax<sup style="vertical-align: text-top; line-height: 1; font-size: smaller">&#174;</sup> (Anthrax Vaccine Adsorbed) in combination with the immunostimulatory oligodeoxynucleotide compound CPG 7909. Its safety, efficacy, and stability have been established through several Phase 1 and Phase 2 clinical studies.</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left; LINE-HEIGHT: 11.4pt; MARGIN-RIGHT: 18pt">Since 2008, Emergent has received five grants and contracts funded by BARDA and the National Institute of Allergy and Infectious Diseases totaling approximately $127 million for the early stage and advanced development of NuThrax, including development of a dry formulation for the vaccine candidate.</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left; LINE-HEIGHT: 11.4pt; MARGIN-RIGHT: 18pt">This contract<font style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif">&#160;</font>HHSO100201600030C for the advanced development and delivery of NuThrax is funded by BARDA a division within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services.</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: bold; TEXT-ALIGN: left; LINE-HEIGHT: 11.4pt">About Emergent BioSolutions</div>

<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left; LINE-HEIGHT: 11.4pt">Emergent BioSolutions is a global specialty biopharmaceutical company dedicated to one simple mission&#8212;to protect and enhance life.&#160;We develop, manufacture, and deliver a portfolio of medical countermeasures for biological and chemical threats as well as emerging infectious diseases. Through our work, we envision protecting and enhancing 50 million lives with our products by 2025.&#160;Additional information about the company may be found at <font style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif">www.emergentbiosolutions.com</font>.&#160;Follow us @emergentbiosolu.</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: bold; TEXT-ALIGN: left; LINE-HEIGHT: 11.4pt">Safe Harbor Statement</div>

<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left; LINE-HEIGHT: 11.4pt">This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding the total potential realizable value of the contract, the anticipated timing of EUA eligibility, our strategy, future operations, prospects, plans and objectives with respect to NuThrax, and any other statements containing the words "believes," "expects," "anticipates," "intends," "plans," "estimates" and similar expressions, are forward-looking statements. These forward-looking statements are based on our current intentions, beliefs and expectations regarding future events. We cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, we do not undertake to update any forward-looking statement to reflect new information, events or circumstances.</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left; LINE-HEIGHT: 11.4pt">There are a number of important factors that could cause the company's actual results to differ materially from those indicated by such forward-looking statements, including appropriations for the development and procurement of NuThrax under the contract; our ability to secure EUA pre-authorization approval and licensure of NuThrax by FDA within the anticipated timeframe, if at all; BARDA's decisions to exercise options under the contract; and our development and manufacturing capabilities and strategies. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in our periodic reports filed with the SEC, when evaluating our forward-looking statements.</div>

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<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; FONT-WEIGHT: bold; TEXT-ALIGN: left; LINE-HEIGHT: 11.4pt; MARGIN-RIGHT: 18pt">Investor Contact:<font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font>&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160; <font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font>Media Contact:</div>

<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left; LINE-HEIGHT: 11.4pt; MARGIN-RIGHT: 18pt">Robert G. Burrows<font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font>&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160; <font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font>Tracey Schmitt Lintott<font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font></div>

<div style="FONT-SIZE: 10pt; FONT-FAMILY: 'Times New Roman', Times, serif; TEXT-ALIGN: left; LINE-HEIGHT: 11.4pt; MARGIN-RIGHT: 18pt">Vice President, Investor Relations<font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font><font id="TRGRRTFtoHTMLTab" style="FONT-SIZE: 1px; WIDTH: 9pt; DISPLAY: inline-block">&#160;</font>&#160;Senior Vice President, Global Public Affairs</div>

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