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Proc-Type: 2001,MIC-CLEAR
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<SEC-DOCUMENT>0001193125-09-189440.txt : 20091026
<SEC-HEADER>0001193125-09-189440.hdr.sgml : 20091026
<ACCEPTANCE-DATETIME>20090909171633
<PRIVATE-TO-PUBLIC>
ACCESSION NUMBER:		0001193125-09-189440
CONFORMED SUBMISSION TYPE:	CORRESP
PUBLIC DOCUMENT COUNT:		1
FILED AS OF DATE:		20090909

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			REPLIGEN CORP
		CENTRAL INDEX KEY:			0000730272
		STANDARD INDUSTRIAL CLASSIFICATION:	BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
		IRS NUMBER:				042729386
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			0331

	FILING VALUES:
		FORM TYPE:		CORRESP

	BUSINESS ADDRESS:	
		STREET 1:		41 SEYON STREET
		STREET 2:		BUILDING 1, SUITE 100
		CITY:			WALTHAM
		STATE:			MA
		ZIP:			02453
		BUSINESS PHONE:		7814499560

	MAIL ADDRESS:	
		STREET 1:		41 SEYON STREET
		STREET 2:		BUILDING 1, SUITE 100
		CITY:			WALTHAM
		STATE:			MA
		ZIP:			02453
</SEC-HEADER>
<DOCUMENT>
<TYPE>CORRESP
<SEQUENCE>1
<FILENAME>filename1.htm
<TEXT>
<HTML><HEAD>
<TITLE>Correspondence</TITLE>
</HEAD>
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 <P STYLE="margin-top:0px;margin-bottom:0px" ALIGN="center"><FONT FACE="Times New Roman" SIZE="2">Repligen Corporation </FONT></P> <P STYLE="margin-top:0px;margin-bottom:0px" ALIGN="center"><FONT
FACE="Times New Roman" SIZE="2">41 Seyon Street, Building #1, Suite 100 </FONT></P> <P STYLE="margin-top:0px;margin-bottom:0px" ALIGN="center"><FONT FACE="Times New Roman" SIZE="2">Waltham, Massachusetts 02453 </FONT></P> <P
STYLE="margin-top:12px;margin-bottom:0px" ALIGN="right"><FONT FACE="Times New Roman" SIZE="2">September&nbsp;9, 2009 </FONT></P> <P STYLE="margin-top:12px;margin-bottom:0px"><FONT FACE="Times New Roman" SIZE="2">United States Securities and Exchange
Commission </FONT></P> <P STYLE="margin-top:0px;margin-bottom:0px"><FONT FACE="Times New Roman" SIZE="2">Division of Corporation Finance </FONT></P> <P STYLE="margin-top:0px;margin-bottom:0px"><FONT FACE="Times New Roman" SIZE="2">100 F Street N.E.
</FONT></P> <P STYLE="margin-top:0px;margin-bottom:0px"><FONT FACE="Times New Roman" SIZE="2">Washington, D.C. 20549 </FONT></P> <P STYLE="margin-top:12px;margin-bottom:0px"><FONT FACE="Times New Roman" SIZE="2">Attention: Jeffrey Riedler, Assistant
Director </FONT></P> <P STYLE="font-size:12px;margin-top:0px;margin-bottom:0px">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR>
<TD WIDTH="4%" VALIGN="top" ALIGN="left"><FONT FACE="Times New Roman" SIZE="2">RE:</FONT></TD>
<TD ALIGN="left" VALIGN="top"><FONT FACE="Times New Roman" SIZE="2">Repligen Corporation </FONT></TD></TR></TABLE> <P STYLE="margin-top:0px;margin-bottom:0px; margin-left:4%"><FONT FACE="Times New Roman" SIZE="2">Supplemental Response to Form 10-K
for the Year Ended March&nbsp;31, 2008 </FONT></P> <P STYLE="margin-top:0px;margin-bottom:0px; margin-left:4%"><FONT FACE="Times New Roman" SIZE="2">Filed March&nbsp;31, 2009 </FONT></P> <P
STYLE="margin-top:0px;margin-bottom:0px; margin-left:4%"><FONT FACE="Times New Roman" SIZE="2">File No. 000-14656 </FONT></P> <P STYLE="margin-top:12px;margin-bottom:0px"><FONT FACE="Times New Roman" SIZE="2">Dear Mr.&nbsp;Riedler: </FONT></P> <P
STYLE="margin-top:6px;margin-bottom:0px; text-indent:4%"><FONT FACE="Times New Roman" SIZE="2">This letter is being furnished in response to the comments of the Staff (the &#147;Staff&#148;) of the Securities and Exchange Commission (the
&#147;Commission&#148;) in the Commission&#146;s letter dated July&nbsp;14, 2009 (the &#147;Comment Letter&#148;) to Dr.&nbsp;Walter&nbsp;C. Herlihy, Ph.D., President, Chief Executive Officer and Director of Repligen Corporation
(&#147;Repligen&#148; or the &#147;Company&#148;), with respect to the Company&#146;s Supplemental Response to Form 10-K for the fiscal year ended March&nbsp;31, 2008, filed May&nbsp;29, 2009. The response set forth below has been organized in the
same manner in which the Commission&#146;s comments and headings were organized in the Comment Letter. </FONT></P> <P STYLE="margin-top:18px;margin-bottom:0px"><FONT FACE="Times New Roman" SIZE="2"><B><U>Form l0-K for year ended March&nbsp;31, 2008
</U></B></FONT></P> <P STYLE="margin-top:6px;margin-bottom:0px"><FONT FACE="Times New Roman" SIZE="2"><B><U>Item&nbsp;1. Business, page 3 </U></B></FONT></P> <P STYLE="font-size:6px;margin-top:0px;margin-bottom:0px">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR>
<TD WIDTH="4%"><FONT SIZE="1">&nbsp;</FONT></TD>
<TD WIDTH="4%" VALIGN="top" ALIGN="left"><FONT FACE="Times New Roman" SIZE="2"><I>1.</I></FONT></TD>
<TD ALIGN="left" VALIGN="top"><FONT FACE="Times New Roman" SIZE="2"><I>Please provide us with an analysis supporting your determination that you were not substantially dependent on your agreement with Applied as of March&nbsp;31, 2008. Your analysis
should focus on the facts and circumstances as of March&nbsp;31, 2008. If you had reason to believe that your dependence of this agreement would decline after March&nbsp;31, 2008, this information may be relevant but would not be determinative. </I>
</FONT></TD></TR></TABLE> <P STYLE="margin-top:6px;margin-bottom:0px; margin-left:8%"><FONT FACE="Times New Roman" SIZE="2">RESPONSE: We respectfully advise the Staff that our rationale for determining that Repligen Corporation was not materially
dependent upon Applied as of March&nbsp;31, 2008 is based on an assessment of: </FONT></P> <P STYLE="font-size:6px;margin-top:0px;margin-bottom:0px">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR>
<TD WIDTH="14%"><FONT SIZE="1">&nbsp;</FONT></TD>
<TD WIDTH="2%" VALIGN="top" ALIGN="left"><FONT FACE="Times New Roman" SIZE="2">&#149;</FONT></TD>
<TD WIDTH="1%" VALIGN="top"><FONT SIZE="1">&nbsp;</FONT></TD>
<TD ALIGN="left" VALIGN="top"> <P ALIGN="left"><FONT FACE="Times New Roman" SIZE="2">the nature of our business as a development stage research and development biotechnology company and how these revenues are viewed internally in relation to the
long term success of the organization; </FONT></P></TD></TR></TABLE>

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<TD WIDTH="14%"><FONT SIZE="1">&nbsp;</FONT></TD>
<TD WIDTH="2%" VALIGN="top" ALIGN="left"><FONT FACE="Times New Roman" SIZE="2">&#149;</FONT></TD>
<TD WIDTH="1%" VALIGN="top"><FONT SIZE="1">&nbsp;</FONT></TD>
<TD ALIGN="left" VALIGN="top"> <P ALIGN="left"><FONT FACE="Times New Roman" SIZE="2">the materiality of the relationship compared to our overall operations at March&nbsp;31, 2008; </FONT></P></TD></TR></TABLE> <P
STYLE="font-size:6px;margin-top:0px;margin-bottom:0px">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR>
<TD WIDTH="14%"><FONT SIZE="1">&nbsp;</FONT></TD>
<TD WIDTH="2%" VALIGN="top" ALIGN="left"><FONT FACE="Times New Roman" SIZE="2">&#149;</FONT></TD>
<TD WIDTH="1%" VALIGN="top"><FONT SIZE="1">&nbsp;</FONT></TD>
<TD ALIGN="left" VALIGN="top"> <P ALIGN="left"><FONT FACE="Times New Roman" SIZE="2">the potential impact a disruption of that relationship would have on our results and financial position. </FONT></P></TD></TR></TABLE> <P
STYLE="margin-top:6px;margin-bottom:0px; margin-left:8%"><FONT FACE="Times New Roman" SIZE="2">Most development stage biotechnology companies do not have an identifiable revenue source, but rather rely to a great extent on the capital markets to
fund operations as they advance their clinical products to the market. This was especially the case as of March&nbsp;31, 2008 prior to the credit crisis. Repligen is no different than our peers in this regard and has historically accessed the
capital markets for such funding. Fortuitously, the Company historically has also had product line revenue which partially funds operations and Applied is a customer in this regard. Further, as discussed below, our intellectual property assets have
become a much greater source of funding as well. Our core focus, however, remains our research and development operations, and even a complete deterioration in revenue from Applied would not materially detract the Company from continuing to pursue
those goals as we would follow the traditional development stage biotechnology model of accessing the capital markets. </FONT></P> <P STYLE="margin-top:6px;margin-bottom:0px; margin-left:8%"><FONT FACE="Times New Roman" SIZE="2">Further, during the
fiscal year ended March&nbsp;31, 2008, the Company, as disclosed in Note 10 in our Form 10-K, successfully entered into a Settlement Agreement with ImClone Systems, Inc. that yielded $40,170,000 in net proceeds for the Company. The proceeds from
this settlement agreement, in addition to the $18,587,000 of revenue, totaled $58,757,000 of funding from operations for the Company in fiscal 2008. Applied, therefore, represented less than 5% of that funding. Conversely, our largest customer, GE
Healthcare, still represented nearly 20% of this total. In addition, the company announced a significant settlement agreement with Bristol-Myers Squibb on April&nbsp;7, 2008, as disclosed in Note 12 in our Form 10-K, that we believe will result in
cash flows far in excess of the ImClone settlement over the coming years. As a result, and in recognition of the fact that we were seeing Applied revenues trend downward during this timeframe, we did not consider the Company to be financially
dependent upon Applied as of March&nbsp;31, 2008. </FONT></P> <P STYLE="font-size:6px;margin-top:0px;margin-bottom:0px">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
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<TD WIDTH="4%"><FONT SIZE="1">&nbsp;</FONT></TD>
<TD WIDTH="4%" VALIGN="top" ALIGN="left"><FONT FACE="Times New Roman" SIZE="2"><I>2.</I></FONT></TD>
<TD ALIGN="left" VALIGN="top"><FONT FACE="Times New Roman" SIZE="2"><I>We note your response to our prior comment 2. Please provide proposed disclosure to include information regarding the expiration of the agreement and each party&#146;s
termination rights thereunder. We note that your Form 10-K for the fiscal year ended March&nbsp;31, 2009 filed June&nbsp;11, 2009 does not contain this information. </I></FONT></TD></TR></TABLE> <P STYLE="margin-top:0px;margin-bottom:0px"><FONT
SIZE="1">&nbsp;</FONT></P>
 <P STYLE="margin-top:0px;margin-bottom:0px" ALIGN="center"><FONT FACE="Times New Roman" SIZE="2">2 </FONT></P>


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 <P STYLE="margin-top:0px;margin-bottom:0px; margin-left:8%"><FONT FACE="Times New Roman" SIZE="2">RESPONSE: We respectfully advise the Staff that we would propose to include in the Company&#146;s annual
report on Form 10-K for the year ended March&nbsp;31, 2010, the following disclosure regarding the material terms of the license agreement with the University of Michigan. All proposed changes to such disclosure compared to previously submitted
disclosures in our annual report on Form 10-K for the year ended March&nbsp;31, 2009 to incorporate the Staff&#146;s recommendations are highlighted in <B><I>bold italic</I></B> print: </FONT></P> <P
STYLE="margin-top:12px;margin-bottom:0px; margin-left:4%; text-indent:4%"><FONT FACE="Times New Roman" SIZE="2"><B>&#147;CTLA4-Ig</B> </FONT></P> <P STYLE="margin-top:6px;margin-bottom:0px; margin-left:8%"><FONT FACE="Times New Roman" SIZE="2">CTLA4
is a key regulator of the activity of the immune system. CTLA4 &#147;turns off&#148; the immune system after it has successfully cleared a bacterial or viral infection by blocking the activation of T-cells, the immune cells responsible for
initiating an immune response. In the 1990&#146;s, our collaborators at the University of Michigan <B><I>(&#147;Michigan&#148;) </I></B>and the U.S. Navy demonstrated in animal models that a fusion protein consisting of fragments of CTLA4 and an
antibody (&#147;CTLA4-Ig&#148;) could be used to treat certain autoimmune diseases. This research finding resulted in the granting of U.S. patent No.&nbsp;6,685,941 (&#147;the &#145;941 Patent&#148;) covering the treatment of certain auto-immune
disorders including rheumatoid arthritis with CTLA4-Ig. The &#145;941 Patent is owned by Michigan and exclusively licensed to Repligen<B><I> until the expiration of the patent in February 2021</I></B>. In consideration of this exclusive license,
Repligen agreed to pay Michigan 15% of all royalty income received, after deducting legal expenses. There are no annual or other fees associated with this agreement. <B><I>Repligen is not currently, nor do we anticipate developing any products under
this agreement. As a result, the primary remaining obligations of Repligen under this agreement are to remit 15% of royalty income received to Michigan and to fund patent prosecution costs as they arise. This agreement may be terminated by either
party at any time, although Repligen&#146;s obligation to remit 15% of royalty income received extends beyond any termination. </I></B>Under this agreement, since its inception through fiscal year 2009, Repligen has paid $1.1 million to the
University of Michigan. CTLA4-Ig&#146;s mechanism of action is different from the current therapies for autoimmune disease or organ transplant rejection, thus it may provide a treatment for patients who are refractory to existing therapies.&#148;
</FONT></P> <P STYLE="margin-top:0px;margin-bottom:0px"><FONT SIZE="1">&nbsp;</FONT></P>
 <P STYLE="margin-top:0px;margin-bottom:0px" ALIGN="center"><FONT FACE="Times New Roman" SIZE="2">3 </FONT></P>


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 <P STYLE="margin-top:0px;margin-bottom:0px" ALIGN="center"><FONT FACE="Times New Roman" SIZE="2">*** </FONT></P> <P STYLE="margin-top:12px;margin-bottom:0px; text-indent:4%"><FONT FACE="Times New Roman"
SIZE="2">The Company acknowledges that: </FONT></P> <P STYLE="font-size:6px;margin-top:0px;margin-bottom:0px">&nbsp;</P>
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<TR>
<TD WIDTH="5%"><FONT SIZE="1">&nbsp;</FONT></TD>
<TD WIDTH="2%" VALIGN="top" ALIGN="left"><FONT FACE="Times New Roman" SIZE="2">&#149;</FONT></TD>
<TD WIDTH="1%" VALIGN="top"><FONT SIZE="1">&nbsp;</FONT></TD>
<TD ALIGN="left" VALIGN="top"> <P ALIGN="left"><FONT FACE="Times New Roman" SIZE="2">the Company is responsible for the adequacy and accuracy of the disclosure in the filing; </FONT></P></TD></TR></TABLE> <P
STYLE="font-size:6px;margin-top:0px;margin-bottom:0px">&nbsp;</P>
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<TD WIDTH="5%"><FONT SIZE="1">&nbsp;</FONT></TD>
<TD WIDTH="2%" VALIGN="top" ALIGN="left"><FONT FACE="Times New Roman" SIZE="2">&#149;</FONT></TD>
<TD WIDTH="1%" VALIGN="top"><FONT SIZE="1">&nbsp;</FONT></TD>
<TD ALIGN="left" VALIGN="top"> <P ALIGN="left"><FONT FACE="Times New Roman" SIZE="2">staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to the filing; and
</FONT></P></TD></TR></TABLE> <P STYLE="font-size:6px;margin-top:0px;margin-bottom:0px">&nbsp;</P>
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<TR>
<TD WIDTH="5%"><FONT SIZE="1">&nbsp;</FONT></TD>
<TD WIDTH="2%" VALIGN="top" ALIGN="left"><FONT FACE="Times New Roman" SIZE="2">&#149;</FONT></TD>
<TD WIDTH="1%" VALIGN="top"><FONT SIZE="1">&nbsp;</FONT></TD>
<TD ALIGN="left" VALIGN="top"> <P ALIGN="left"><FONT FACE="Times New Roman" SIZE="2">the Company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United
States. </FONT></P></TD></TR></TABLE> <P STYLE="margin-top:6px;margin-bottom:0px; margin-left:4%; text-indent:4%"><FONT FACE="Times New Roman" SIZE="2">If you have any questions with regard to the Company&#146;s responses, need further supplemental
information or would like to discuss any of the matters covered in this letter, please contact the undersigned at (781)&nbsp;250-0111. </FONT></P> <P STYLE="font-size:12px;margin-top:0px;margin-bottom:0px">&nbsp;</P><DIV ALIGN="right">
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<TD VALIGN="top"><FONT FACE="Times New Roman" SIZE="2">Sincerely,</FONT></TD></TR>
<TR>
<TD HEIGHT="16"></TD></TR>
<TR>
<TD VALIGN="top"> <P STYLE="margin-top:0px;margin-bottom:1px;border-bottom:1px solid #000000"><FONT FACE="Times New Roman" SIZE="2">/s/ William J. Kelly</FONT></P></TD></TR>
<TR>
<TD VALIGN="top"><FONT FACE="Times New Roman" SIZE="2">William J. Kelly</FONT></TD></TR>
<TR>
<TD VALIGN="top"><FONT FACE="Times New Roman" SIZE="2">Chief Financial Officer</FONT></TD></TR>
</TABLE></DIV> <P STYLE="margin-top:0px;margin-bottom:0px"><FONT SIZE="1">&nbsp;</FONT></P>
 <P STYLE="margin-top:0px;margin-bottom:0px" ALIGN="center"><FONT FACE="Times New Roman" SIZE="2">4 </FONT></P>

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