<SEC-DOCUMENT>0001341004-12-000132.txt : 20120131
<SEC-HEADER>0001341004-12-000132.hdr.sgml : 20120131
<ACCEPTANCE-DATETIME>20120131170857
ACCESSION NUMBER:		0001341004-12-000132
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20120128
ITEM INFORMATION:		Entry into a Material Definitive Agreement
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20120131
DATE AS OF CHANGE:		20120131

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			DELCATH SYSTEMS INC
		CENTRAL INDEX KEY:			0000872912
		STANDARD INDUSTRIAL CLASSIFICATION:	SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841]
		IRS NUMBER:				061245881
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-16133
		FILM NUMBER:		12560027

	BUSINESS ADDRESS:	
		STREET 1:		810 SEVENTH AVENUE
		STREET 2:		FL 35
		CITY:			NEW YORK
		STATE:			NY
		ZIP:			10019
		BUSINESS PHONE:		212-489-2100

	MAIL ADDRESS:	
		STREET 1:		810 SEVENTH AVENUE
		STREET 2:		FL 35
		CITY:			NEW YORK
		STATE:			NY
		ZIP:			10019
</SEC-HEADER>
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<div style="LINE-HEIGHT: 13.7pt; TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="center"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt; FONT-WEIGHT: bold">CURRENT REPORT</font></div>

<div style="LINE-HEIGHT: 13.7pt; TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="center"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt; FONT-WEIGHT: bold">PURSUANT TO SECTION 13 OR 15(D) OF THE</font></div>

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<div style="LINE-HEIGHT: 13.7pt; TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="center"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt">Date of report (Date of earliest event reported): <font style="DISPLAY: inline; FONT-WEIGHT: bold">January 31, 2012 (January 28, 2012)</font></font></div>

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<div style="LINE-HEIGHT: 13.7pt; TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="center"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt">(Exact name of registrant as specified in its charter)</font></div>

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<div style="LINE-HEIGHT: 13.7pt; TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="center"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt">810 Seventh Avenue, 35<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top">th</font> Floor, New York, New York, 10019</font></div>

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<div style="LINE-HEIGHT: 13.7pt; TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt">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):</font></div>

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<div style="LINE-HEIGHT: 13.7pt; TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt; FONT-WEIGHT: bold">Item 1.01 Entry into a Material Definitive Agreement.</font></div>

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<div style="LINE-HEIGHT: 13.7pt; TEXT-INDENT: 36pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt">On January 28, 2012, Delcath Systems, Inc. (the &#8220;Company&#8221;) entered into an amendment (&#8220;Amendment No. 4&#8221;) to the Cooperative Research and Development Agreement (&#8220;CRADA&#8221;) with the National Cancer Institute (&#8220;NCI&#8221;). The existing CRADA expired on December 14, 2011, and Amendment No. 4 extends the CRADA for an additional year to December 14, 2012. Under the one year extension, the Company will provide $1,000,000 of additional funding to the NCI for clinical support.</font></div>

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<div style="LINE-HEIGHT: 13.7pt; TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: times new roman, serif; FONT-SIZE: 12pt">Amendment No. 4 to the Cooperative Research and Development Agreement, dated as of January 28, 2012, between Delcath Systems, Inc. and the National Cancer Institute</font></div>
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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="center"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt; FONT-WEIGHT: bold">Amendment #4</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt">The purpose of this amendment is to change certain terms of the above-referenced Cooperative Research and Development Agreement (CRADA). These changes are reflected below, and except for these changes, all other provisions of the original CRADA remain in full force and effect. Two originals of this amendment are provided for execution; one is to remain with the National Cancer Institute and the other is to remain with the Collaborator.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt">1) The term of the CRADA is extended to an additional one (1) year term (December 14, 2011 &#8211; December 14, 2012). This additional term is for completion of all ongoing studies and activities under the CRADA. During this term, Collaborator (Delcath Systems, Inc.) will provide complete access to the data in the eCaseLink database for all intramural and extramural studies under the CRADA. This is inclusive of all updates and improvements to the eCaseLink database. Once the database is complete, either the database or a copy of the completed database will be transferred to the NCI Surgery Branch. In addition, all correspondence, requests and notices related to activities performed under the CRADA will be directed to Drs. Steven A. Rosenberg or Marybeth Hughes, Ms. MaryAnn Toomey, or their designees, in the NCI Surgery Branch only; all other notices relating to the CRADA agreement will be directed to the Technology Transfer Center, NCI.</font></div>

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<div align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt"><font style="DISPLAY: inline; FONT-WEIGHT: bold">Assignment</font>. Neither this CRADA nor any rights or obligations of any Party hereunder shall be assigned or otherwise transferred by either Party without the prior written consent of the other Party. <font style="DISPLAY: inline; TEXT-DECORATION: underline">The Collaborator acknowledges the applicability of 41 U.S.C. &#167; 15, the Anti Assignment Act, to this Agreement. The Parties agree that the identity of the Collaborator is material to the performance of this CRADA and that the duties under this CRADA are nondelegable.</font></font></div>
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