<SEC-DOCUMENT>0001564590-17-011886.txt : 20170531
<SEC-HEADER>0001564590-17-011886.hdr.sgml : 20170531
<ACCEPTANCE-DATETIME>20170531090517
ACCESSION NUMBER:		0001564590-17-011886
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20170526
ITEM INFORMATION:		Entry into a Material Definitive Agreement
FILED AS OF DATE:		20170531
DATE AS OF CHANGE:		20170531

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			CYTORI THERAPEUTICS, INC.
		CENTRAL INDEX KEY:			0001095981
		STANDARD INDUSTRIAL CLASSIFICATION:	SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841]
		IRS NUMBER:				330827593
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-34375
		FILM NUMBER:		17879669

	BUSINESS ADDRESS:	
		STREET 1:		3020 CALLAN ROAD
		CITY:			SAN DIEGO
		STATE:			CA
		ZIP:			92121
		BUSINESS PHONE:		8584580900

	MAIL ADDRESS:	
		STREET 1:		3020 CALLAN ROAD
		CITY:			SAN DIEGO
		STATE:			CA
		ZIP:			92121

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	MACROPORE INC
		DATE OF NAME CHANGE:	20010320
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
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<FILENAME>cytx-8k_20170526.htm
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<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;color:#000000;font-size:11pt;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:11pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">SECURITIES AND EXCHANGE COMMISSION</p>
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;color:#000000;font-size:11pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Washington, D.C. 20549</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;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:16pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Form 8-K</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;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:11pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Current Report&#160;</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;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:11pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:11pt;">&nbsp;</p>
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;text-indent:0%;color:#000000;font-size:11pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Date of Report<font style="font-weight:bold;">&#160;</font>(Date of earliest event reported):<font style="font-weight:bold;">&#160; May 26, 2017</font></p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;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:20pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">CYTORI THERAPEUTICS, INC.</p>
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;text-indent:0%;color:#000000;font-size:11pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">(Exact name of registrant as specified in its charter)</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-family:Times New Roman;font-size:10pt;font-style:normal;text-transform:none;font-variant: normal;">001-34375</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-family:Times New Roman;font-size:10pt;font-style:normal;text-transform:none;font-variant: normal;">33-0827593</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;">(State or Other Jurisdiction</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;">of Incorporation)</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;">(Commission</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;">File Number)</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;">Identification Number)</p></td>
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<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:11pt;">&nbsp;</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;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:11pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">3020 Callan Road, San Diego, California 92121</p>
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;text-indent:0%;color:#000000;font-size:11pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">(Address of principal executive offices, with zip code)</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;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:11pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">(858) 458-0900</p>
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;text-indent:0%;color:#000000;font-size:11pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">(Registrant's telephone number, including area code)</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;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:11pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">n/a</p>
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;text-indent:0%;color:#000000;font-size:11pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">(Former name or former address, if changed since last report)</p>
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:11pt;">&nbsp;</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:11pt;">&nbsp;</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:3.67%;color:#000000;font-family:Times New Roman;font-size:10pt;font-weight:normal;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 (<font style="font-style:italic;">see</font> General Instruction A.2. below):</p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;color:#000000;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><a name="hangingindent"></a><a name="hangingindent"></a>&#160;</p>
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<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;color:#000000;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&#160;</p>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;color:#000000;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&#160;&#160;&#160;&#160;Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))</p>
<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
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<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><a name="pgbrk"></a>Indicate by check mark whether the registrant<font style="color:#070707;"> is an emerging growth company as defined in as defined in Rule 405 of the Securities</font></p>
<p style="margin-bottom:0pt;margin-top:0pt;margin-right:7.22%;text-indent:-0.04%;color:#070707;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Act of 1933 (&#167; 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (&#167; 240.12b-2 of this chapter). </p>
<p style="margin-top:6pt;margin-bottom:0pt;text-indent:0%;color:#070707;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">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 13(a) of the Exchange Act.<font style="color:#000000;font-size:11pt;"> &#9633;</font> </p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;color:#070707;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Emerging<font style="letter-spacing:0.2pt;"> </font>growth<font style="letter-spacing:0.15pt;"> </font>company<font style="letter-spacing:0.45pt;"> </font><font style="color:#000000;font-size:11pt;">&#9633;</font></p>
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<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;font-family:Times New Roman;font-size:10pt;font-style:normal;text-transform:none;font-variant: normal;"><a name="hdr"></a><a name="_AEIOULastRenderedPageBreakAEIOU2"></a><font style="font-weight:bold;font-family:Times New Roman;font-size:10pt;font-style:normal;text-transform:none;font-variant: normal;">Item 1.01 Entry Into a Material Definitive Agreement.</font></p>
<p style="margin-top:10pt;margin-bottom:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">On May 26, 2017, Cytori Therapeutics, Inc., a Delaware corporation (the &#8220;Company&#8221;) received notice from the Biomedical Advanced Research&#160;and Development Authority (&#8220;BARDA&#8221;), a division of the&#160;U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, that BARDA had agreed to an Amendment of Solicitation/Modification of Contract (Amendment No. 0008) (the &#8220;Eighth Amendment&#8221;) of the Contract HHSO100201200008C, dated September 27, 2012 (as amended, the &#8220;BARDA Agreement&#8221;).&nbsp;&nbsp;Pursuant to the Eighth Amendment, BARDA exercised its unilateral right to exercise Option 2 of the BARDA Agreement, which provides for the assessment of Cytori&#174; Cell Therapy&#8482;, or DCCT-10, as an adjunct therapy in thermal burn injury through the Company&#8217;s RELIEF pilot clinical trial (the &#8220;Pilot Trial&#8221;).&nbsp;&nbsp;Although the Company received formal notice of BARDA&#8217;s option exercise on May 26, 2017, the Eight Amendment is deemed effective as of May 23, 2017, which is the date BARDA signed the Eighth Amendment.</p>
<p style="margin-top:10pt;margin-bottom:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Option 2 was previously amended in a separate Amendment of Solicitation/Modification of Contract (Amendment No. 0007), dated May 19, 2017, by and between the Company and BARDA (the &#8220;Seventh Amendment&#8221; and together with the Eighth Amendment, the &#8220;Amendments&#8221;).&nbsp;&nbsp;Pursuant to the Amendments, Option 2 of the BARDA Agreement was amended&nbsp;&nbsp;to (i) revise the statement of work setting forth the clinical, regulatory and other activities relating to the Pilot Trial and (ii) set forth and provide the additional funding, and terms thereof, for the execution of the activities outlined in Option 2.&nbsp;&nbsp;</p>
<p style="margin-top:10pt;margin-bottom:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">In accordance with the terms of the Amendments, BARDA will provide the Company with reimbursement of costs incurred, plus payment of a fixed fee, in the aggregate amount of up to approximately $13.4 million (the &#8220;Funding Amount&#8221;).&nbsp;&nbsp;The Company is responsible for further costs in excess of the Funding Amount, if any, to meet the objectives of the Pilot Trial. The Amendments also extend the term of the BARDA Agreement and the period of performance of Option 2 of the BARDA Agreement to November 30, 2020.&nbsp;&nbsp;</p>
<p style="margin-top:10pt;margin-bottom:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The foregoing is only a brief description of the material terms of the Amendments and does not purport to be a complete description of the rights and obligations of the parties thereunder. The foregoing description is qualified in its entirety by reference to the Amendments, which will be filed as exhibits to the Company&#8217;s next Quarterly Report on Form 10-Q.</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&nbsp;</p>
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<p style="margin-bottom:0pt;margin-top:0pt;font-weight:bold;font-family:Times New Roman;font-size:10pt;font-style:normal;text-transform:none;font-variant: normal;"><font style="font-weight:bold;font-family:Times New Roman;font-size:10pt;font-style:normal;text-transform:none;font-variant: normal;">SIGNATURES</font></p>
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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:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">By: /s/ Tiago Girao</p></td>
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