<SEC-DOCUMENT>0001193125-15-054226.txt : 20150325
<SEC-HEADER>0001193125-15-054226.hdr.sgml : 20150325
<ACCEPTANCE-DATETIME>20150219161400
<PRIVATE-TO-PUBLIC>
ACCESSION NUMBER:		0001193125-15-054226
CONFORMED SUBMISSION TYPE:	CORRESP
PUBLIC DOCUMENT COUNT:		1
FILED AS OF DATE:		20150219

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:			1231

	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
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<TITLE>Correspondence</TITLE>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:56%; font-size:10pt; font-family:Times New Roman" ALIGN="center">February&nbsp;19, 2015 </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><U>Via EDGAR </U></B></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Jeffrey Riedler </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Assistant Director </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Division of Corporation Finance </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">U.S. Securities and Exchange Commission </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">100 F Street, N.E. </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Washington, DC 20549 </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="8%">&nbsp;</TD>
<TD WIDTH="5%" VALIGN="top" ALIGN="left"><B>Re:</B></TD>
<TD ALIGN="left" VALIGN="top"><B>Repligen Corporation </B></TD></TR></TABLE> <P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:13%; font-size:10pt; font-family:Times New Roman"><B>Form 10-K for the fiscal year ended December 31, 2013 </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:13%; font-size:10pt; font-family:Times New Roman"><B>Filed March 14, 2014 </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:13%; font-size:10pt; font-family:Times New Roman"><B>File No. 000-14656 </B></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Dear
Mr.&nbsp;Riedler: </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:8%; font-size:10pt; font-family:Times New Roman">This letter is submitted on behalf of Repligen Corporation (the &#147;<B>Company</B>&#148;) in response to comments of
the staff of the Division of Corporation Finance (the &#147;<B>Staff</B>&#148;) of the Securities and Exchange Commission (the &#147;<B>Commission</B>&#148;) with respect to the Company&#146;s Form 10-K for the fiscal year ended December&nbsp;31,
2013 (the &#147;<B>Form 10-K</B>&#148;) as set forth in your letter, dated February&nbsp;13, 2015, and prior letter dated December&nbsp;23, 2014. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:8%; font-size:10pt; font-family:Times New Roman">For reference purposes, the Staff&#146;s numbered comments have been reproduced in italics herein with responses immediately following such
comment. Page references in the responses refer to the pages in the Form 10-K as filed with the Commission. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>Research and Development, page 4 </U></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; text-indent:8%; font-size:10pt; font-family:Times New Roman">1.<I> We note your response to our prior comment 2. Notwithstanding your confidential treatment for provisions and terms in the HDAC Agreement
with BioMarin, we deem information regarding the parties&#146; rights and obligations, duration of the agreement and termination provisions to be material to investors. Accordingly, please expand your proposed disclosure to be included in future
filing to provide the parties rights and obligations, duration of the agreement and termination provisions.</I> </P>

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<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">Mr. Jeffrey Riedler </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Securities and Exchange Commission </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">February 19, 2015 </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"> Page
 2
 </P> <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P>
 <P STYLE="margin-top:0pt; margin-bottom:0pt; text-indent:8%; font-size:10pt; font-family:Times New Roman"><U>Response to Comment No.&nbsp;1</U>: </P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; text-indent:8%; font-size:10pt; font-family:Times New Roman">The Company acknowledges the Staff&#146;s comment. In future filings, the Company will expand its disclosure regarding the HDAC Agreement with
BioMarin substantially as set forth below in italicized and underlined text. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>HDAC Agreement with BioMarin </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; text-indent:8%; font-size:10pt; font-family:Times New Roman"><I></I>On January&nbsp;21, 2014, we out-licensed our HDACi portfolio, which includes the Friedreich&#146;s ataxia program, to BioMarin
Pharmaceuticals Inc. Friedreich&#146;s ataxia is an inherited disease that causes progressive damage to the nervous system resulting in symptoms ranging from impaired walking and speech problems to heart disease. <I><U>Pursuant to the terms of the
agreement, BioMarin agrees to use commercially reasonable efforts to commercialize HDACi portfolio product until the later of (i)&nbsp;the expiration of the last-to-expire valid claim of an issued and unexpired patent or pending patent application
claiming a compound included in the agreement or (ii)&nbsp;10 years.</U></I> Under the terms of the agreement, Repligen received an upfront payment of $2 million in January 2014 from BioMarin and we have the potential to receive up to $160 million
in future milestone payments for <I><U>BioMarin&#146;s</U></I> development, regulatory approval and commercial sale of portfolio compounds included in the agreement. These potential milestone payments are approximately 37% related to clinical
development and 63% related to initial commercial sales in specific geographies. In addition, Repligen is eligible to receive royalties on sales of qualified products developed. The royalty rates are tiered and begin in the mid-single-digits for the
first HDACi portfolio product and for the first non-HDACi portfolio product with lesser amounts for any backup products developed under the agreement. Repligen&#146;s receipt of these royalties is subject to customary offsets and deductions. There
are no refund provisions in this agreement.<I> <U>Royalties under this agreement are paid on a country-by-country basis during the period beginning on the first commercial sale of a compound in such country, until the later of: (i)&nbsp;the
expiration of exclusivity period granted by a governmental authority to prevent the entry of generic product into such country; (ii)&nbsp;the expiration of the last-to-expire valid claim of an issued and unexpired patent or pending patent
application claiming such compound in such country; or (iii)&nbsp;ten years following the first commercial sale of such HDACi portfolio product in any country. Royalty payments on products derived from the compounds included in the agreement are
calculated by multiplying net sales of such product for the calendar year by an applicable royalty rate based on incremental net sale amounts.</U> </I></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:8%; font-size:10pt; font-family:Times New Roman"><I></I>2. <I>We note your response to our prior comment 3. Notwithstanding your confidential treatment request for cessation provisions of
royalties, we deem information relating to the duration of the agreement to be material to investors. Accordingly, please expand your proposed disclosure to be included in future filings to provide the expiration date of the last to expire patent
and the &#147;predetermined time&#148; referenced in your disclosure on which the payment of royalties is based. </I></P>

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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Mr. Jeffrey Riedler </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Securities and Exchange Commission </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">February 19, 2015 </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"> Page
 3
 </P> <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P>
 <P STYLE="margin-top:0pt; margin-bottom:0pt; text-indent:8%; font-size:10pt; font-family:Times New Roman"><U>Response to Comment No.&nbsp;2</U>: </P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; text-indent:8%; font-size:10pt; font-family:Times New Roman">The Company acknowledges the Staff&#146;s comment and respectfully directs the Staff&#146;s attention to the Company&#146;s Current Report on
Form 8-K, filed on January&nbsp;30, 2015, in which the Company discloses that, on January&nbsp;26, 2015, the Company received from Pfizer a notice of termination for convenience under the SMA Agreement. In light of the termination of the SMA
Agreement, in future filings, the Company will modify its disclosure regarding the SMA Agreement with Pfizer substantially as set forth below in italicized and underlined text. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>SMA Agreement with Pfizer </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">On
December&nbsp;28, 2012, we entered into an exclusive worldwide licensing agreement (the &#147;License Agreement&#148;) with Pfizer to advance the SMA program, which is led by RG3039 and also includes backup compounds and enabling technologies. Under
the terms of the License Agreement, we received $5 million from Pfizer as an upfront payment on January&nbsp;22, 2013 and a $1 million milestone payment on September&nbsp;4, 2013. Pursuant to this License Agreement, Pfizer assumed full
responsibility for the SMA program, including the conduct of the clinical trials necessary for any product approvals<I>. <U>On January&nbsp;26, 2015, Pfizer issued to us a notice of its termination of the License Agreement for convenience, effective
as of April&nbsp;26, 2015. </U></I> </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>Patent, Licenses and Proprietary Rights, page 6 </U></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; text-indent:8%; font-size:10pt; font-family:Times New Roman"><I></I>3. <I>We note your response to our prior comment 5. Please expand your proposed disclosure to provide the expected expiration date if
your HDAC inhibitors patent application is granted. </I></P> <P STYLE="margin-top:18pt; margin-bottom:0pt; text-indent:8%; font-size:10pt; font-family:Times New Roman"><U>Response to Comment No.&nbsp;3</U>: </P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; text-indent:8%; font-size:10pt; font-family:Times New Roman">The Company acknowledges the Staff&#146;s comment. In future filings, the Company will expand its disclosure regarding its HDAC patent
applications substantially as set forth below in italicized and underlined text: </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:8%; font-size:10pt; font-family:Times New Roman"><I></I>On January&nbsp;21, 2014, the Company
out-licensed its HDAC Inhibitor (HDACi) portfolio to BioMarin Pharmaceuticals Inc. The Company&#146;s outlicensed HDACi portfolio included patent applications in the United States as well as patent applications in the EU, Canada, Japan and
Australia. <I><U>Patents, if any, that are granted based on these patent applications are expected to expire from 2029 to 2032. </U> </I></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center">*&nbsp;&nbsp;&nbsp;&nbsp;*&nbsp;&nbsp;&nbsp;&nbsp;* </P>

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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Mr. Jeffrey Riedler </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Securities and Exchange Commission </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">February 19, 2015 </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"> Page
 4
 </P> <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P>
 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">On behalf of the Company, I hereby acknowledge that: </P>
<P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TR>
<TD WIDTH="1%">&nbsp;</TD>
<TD WIDTH="2%" VALIGN="top" ALIGN="left">&#149;</TD>
<TD WIDTH="1%" VALIGN="top">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top">the Company is responsible for the adequacy and accuracy of the disclosure in the filing; </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>
<TD WIDTH="1%">&nbsp;</TD>
<TD WIDTH="2%" VALIGN="top" ALIGN="left">&#149;</TD>
<TD WIDTH="1%" VALIGN="top">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top">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 </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>
<TD WIDTH="1%">&nbsp;</TD>
<TD WIDTH="2%" VALIGN="top" ALIGN="left">&#149;</TD>
<TD WIDTH="1%" VALIGN="top">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top">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. </TD></TR></TABLE>

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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Mr. Jeffrey Riedler </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Securities and Exchange Commission </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">February 19, 2015 </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"> Page
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 </P> <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P>
 <P STYLE="margin-top:0pt; margin-bottom:0pt; text-indent:8%; font-size:10pt; font-family:Times New Roman">Should you have any further comments or questions with regard to the foregoing, please do not
hesitate to contact the undersigned by phone at 781-419-1862 or by e-mail at jsnodgres@repligen.com or Arthur R. McGivern by phone at 617-642-5702 or by email at amcgivern@goodwinprocter.com. </P>
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<TD VALIGN="top" COLSPAN="5">Sincerely,</TD></TR>
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<TD VALIGN="top" COLSPAN="3"> <P STYLE="margin-top:0pt; margin-bottom:1pt; border-bottom:1px solid #000000; font-size:10pt; font-family:Times New Roman">/s/ Jon Snodgres</P></TD></TR>
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<TD VALIGN="top">Name:</TD>
<TD VALIGN="bottom"></TD>
<TD VALIGN="top">Jon Snodgres</TD></TR>
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<TD VALIGN="top"></TD>
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<TD VALIGN="top">Title:</TD>
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<TD VALIGN="top">Chief Financial Officer</TD></TR>
</TABLE></DIV> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="4%" VALIGN="top" ALIGN="left">Cc:</TD>
<TD ALIGN="left" VALIGN="top">Walter C. Herlihy </TD></TR></TABLE> <P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:13%; font-size:10pt; font-family:Times New Roman"><I>Repligen Corporation</I> </P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman">Arthur R. McGivern </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman">Courtney M.
Gaughan </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:13%; font-size:10pt; font-family:Times New Roman"><I>Goodwin Procter LLP</I> </P>
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