<SEC-DOCUMENT>0000950123-16-022914.txt : 20170601
<SEC-HEADER>0000950123-16-022914.hdr.sgml : 20170601
<ACCEPTANCE-DATETIME>20161228172245
<PRIVATE-TO-PUBLIC>
ACCESSION NUMBER:		0000950123-16-022914
CONFORMED SUBMISSION TYPE:	DRSLTR
PUBLIC DOCUMENT COUNT:		2
FILED AS OF DATE:		20161228

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			UroGen Pharma Ltd.
		CENTRAL INDEX KEY:			0001668243
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				000000000
		STATE OF INCORPORATION:			L3
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		DRSLTR

	BUSINESS ADDRESS:	
		STREET 1:		9 HA'TA'ASIYA ST
		CITY:			RA'ANANA
		STATE:			L3
		ZIP:			4365007
		BUSINESS PHONE:		972 9 770 7601

	MAIL ADDRESS:	
		STREET 1:		9 HA'TA'ASIYA ST
		CITY:			RA'ANANA
		STATE:			L3
		ZIP:			4365007
</SEC-HEADER>
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<TYPE>DRSLTR
<SEQUENCE>1
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Joshua A. Kaufman </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">+1 212 479 6495 </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Josh.kaufman@cooley.com </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">December&nbsp;28, 2016 </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">By EDGAR and Hand Delivery </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">United States 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>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR>
<TD WIDTH="10%" VALIGN="top" ALIGN="left">Attention:</TD>
<TD ALIGN="left" VALIGN="top">Ms.&nbsp;Suzanne Hayes </TD></TR></TABLE>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR>
<TD WIDTH="10%" VALIGN="top" ALIGN="left">&nbsp;&nbsp;&nbsp;&nbsp;</TD>
<TD ALIGN="left" VALIGN="top">Mr.&nbsp;Joseph McCann </TD></TR></TABLE>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR>
<TD WIDTH="10%" VALIGN="top" ALIGN="left">&nbsp;&nbsp;&nbsp;&nbsp;</TD>
<TD ALIGN="left" VALIGN="top">Mr.&nbsp;Joshua Samples </TD></TR></TABLE>
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<TR>
<TD WIDTH="10%" VALIGN="top" ALIGN="left">&nbsp;&nbsp;&nbsp;&nbsp;</TD>
<TD ALIGN="left" VALIGN="top">Mr.&nbsp;Mark Brunhofer </TD></TR></TABLE>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR>
<TD WIDTH="10%" VALIGN="top" ALIGN="left">&nbsp;&nbsp;&nbsp;&nbsp;</TD>
<TD ALIGN="left" VALIGN="top">Mr.&nbsp;James Rosenberg </TD></TR></TABLE> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TR>
<TD WIDTH="4%" VALIGN="top" ALIGN="left"><B>Re:</B></TD>
<TD ALIGN="left" VALIGN="top"><B>UroGen Pharma Ltd. </B></TD></TR></TABLE>
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<TR>
<TD WIDTH="4%" VALIGN="top" ALIGN="left"><B>&nbsp;&nbsp;&nbsp;&nbsp;</B></TD>
<TD ALIGN="left" VALIGN="top"><B>Amendment No.&nbsp;5 to Draft Registration Statement on Form F-1 </B></TD></TR></TABLE>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR>
<TD WIDTH="4%" VALIGN="top" ALIGN="left"><B>&nbsp;&nbsp;&nbsp;&nbsp;</B></TD>
<TD ALIGN="left" VALIGN="top"><B>Submitted December&nbsp;7, 2016 </B></TD></TR></TABLE>
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<TD WIDTH="4%" VALIGN="top" ALIGN="left"><B>&nbsp;&nbsp;&nbsp;&nbsp;</B></TD>
<TD ALIGN="left" VALIGN="top"><B>CIK No.&nbsp;0001668243 </B></TD></TR></TABLE> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Ladies and Gentlemen: </P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">On behalf of UroGen Pharma Ltd. (&#147;<B><I>UroGen</I></B>&#148; or the &#147;<B><I>Company</I></B>&#148;), we are responding to the comments (the
&#147;<B><I>Comments</I></B>&#148;) of the staff (the &#147;<B><I>Staff</I></B>&#148;) of the Securities and Exchange Commission (the &#147;<B><I>Commission</I></B>&#148;) contained in its letter, dated December&nbsp;20, 2016 (the
&#147;<B><I>Comment Letter</I></B>&#148;), relating to the above referenced Amendment No.&nbsp;5 to the Confidential Draft Registration Statement on Form F-1 (the &#147;<B><I>Draft Registration Statement</I></B>&#148;). </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In response to the Comments set forth in the Comment Letter, the Company has revised the Draft Registration Statement and is confidentially submitting via
EDGAR a revised draft (the &#147;<B><I>Amended DRS</I></B>&#148;) with this response letter. For the Staff&#146;s reference, we are also delivering three copies of the Amended DRS marked to show all changes from the Draft Registration Statement.
</P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">For ease of reference, set forth below are the Company&#146;s responses to the Comments. The numbering of the paragraphs below corresponds to the
numbering of the Comments, which for your convenience we have incorporated into this response letter. Page references in the text of this response letter correspond to the page numbers of the Amended DRS. Capitalized terms used in this letter but
not otherwise defined herein shall have the meanings set forth in the Amended DRS. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>Prospectus Summary, page 1 </U></P>
<P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="4%">&nbsp;</TD>
<TD WIDTH="4%" VALIGN="top" ALIGN="left"><I></I><B>1.</B></TD>
<TD ALIGN="left" VALIGN="top"><B></B><I>We refer to your disclosure on page 87 concerning the clinical results observed in the MitoGel Compassionate Use program. Please tell us why you believe it is appropriate to highlight on page 2 of the Summary
that eight of the 11 patients achieved a &#147;complete response&#148; at the primary evaluation time without also highlighting your disclosure on page 87 indicating that three of these eight patients subsequently experienced recurrences of the
condition. </I></TD></TR></TABLE> <P STYLE="margin-top:6pt; margin-bottom:0pt; margin-left:8%; font-size:10pt; font-family:Times New Roman">In response to the Staff&#146;s comment, the Company has revised the second paragraph on page 2 of the
Amended DRS to highlight the disclosure on page 87 indicating that three of the eight patients </P>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center">Cooley
LLP&nbsp;&nbsp;&nbsp;&nbsp;1114 Avenue of the Americas&nbsp;&nbsp;&nbsp;&nbsp;New York, NY&nbsp;&nbsp;&nbsp;&nbsp;10036 </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center">t: (212)
479-6000&nbsp;&nbsp;&nbsp;&nbsp;f: (212) 479-6275&nbsp;&nbsp;&nbsp;&nbsp;cooley.com </P>


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 </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">United States Securities and Exchange Commission </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">December 28, 2016 </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Page Two </P>
<p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P>
 <P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:8%; font-size:10pt; font-family:Times New Roman">
who achieved a complete response in the MitoGel Compassionate Use program at the primary evaluation time subsequently experienced recurrences of the condition. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>License Agreement with Allergan, page 95 </U></P> <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="4%">&nbsp;</TD>
<TD WIDTH="4%" VALIGN="top" ALIGN="left"><I></I><B>2.</B></TD>
<TD ALIGN="left" VALIGN="top"><B></B><I>Please revise to disclose each of the &#147;additional material milestone payments&#148; that you reference on page 96. Also, revise your disclosure to indicate the aggregate milestone consideration you can
earn for each of the development, regulatory and commercial milestone categories you identify. Disclose the nature of the underlying triggering events for each such category. </I></TD></TR></TABLE>
<P STYLE="margin-top:12pt; margin-bottom:0pt; margin-left:8%; font-size:10pt; font-family:Times New Roman">The Company acknowledges the Staff&#146;s comment. The Company respectfully advises the Staff that (i)&nbsp;the amounts of the additional
material milestone payments, (ii)&nbsp;the aggregate milestone consideration the Company is eligible to receive under each of the development, regulatory and commercial milestone categories identified, and (iii)&nbsp;the underlying triggering events
for each such category are confidential and proprietary information for which the Company is requesting confidential treatment. The amounts of the additional material milestone payments, the aggregate milestone consideration the Company is eligible
to receive under each of the development, regulatory and commercial milestone categories identified and the underlying triggering events for each such category are highly negotiated terms and they are the type of information that is typically
maintained as confidential and proprietary in the industry in which the Company operates. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; margin-left:8%; font-size:10pt; font-family:Times New Roman">Further, the milestone payments are highly
speculative and contingent in nature and disclosing the details of all such milestones in the Company&#146;s Draft Registration Statement may lead investors to mistakenly place an unrealistic value on the payment stream from future milestone
payments. Whether and when these events may occur is subject to numerous risks and uncertainties associated with developing biopharmaceutical products, including significant and changing government regulation, the uncertainties of future preclinical
study and clinical trial results, the uncertainties associated with our licensee&#146;s commitment to the program, the uncertainties associated with process development and manufacturing, as well as uncertainties related to sales and marketing
achievements. Any estimate of the probability of the occurrence of these events or the time frame for their achievement would be highly speculative and prone to significant error.</P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; margin-left:8%; font-size:10pt; font-family:Times New Roman">If and when any of these milestones are met and the relevant milestone payments are made, the Company will disclose the receipt of such
payments in its financial statements, Management&#146;s Discussion and Analysis and related disclosure, as necessary. Any such disclosure before the milestones are met and the milestone payments are received would be premature. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; margin-left:8%; font-size:10pt; font-family:Times New Roman">For these reasons, together with the other reasons more specifically set forth in the Company&#146;s request submitted under separate cover
for confidential treatment, dated December&nbsp;28, 2016, the Company believes that disclosing more specific information than the information already set forth in the Draft Registration Statement would cause the Company and Allergan Pharmaceuticals
International Limited to suffer significant competitive injury and could lead to undue reliance by investors when making an investment decision. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; margin-left:8%; font-size:10pt; font-family:Times New Roman">Moreover, the combination of the delayed timing of the potential milestone payments and the uncertainty around the outcomes of the milestones
related to each such payment, make each potential milestone payment, on an individual basis, immaterial to the Company, and therefore make disclosure of such potential milestone payments unnecessary regardless of the confidential treatment
requested. </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;* &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;* </P>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center">Cooley
LLP&nbsp;&nbsp;&nbsp;&nbsp;1114 Avenue of the Americas&nbsp;&nbsp;&nbsp;&nbsp;New York, NY&nbsp;&nbsp;&nbsp;&nbsp;10036 </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center">t: (212)
479-6000&nbsp;&nbsp;&nbsp;&nbsp;f: (212) 479-6275&nbsp;&nbsp;&nbsp;&nbsp;cooley.com </P>


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 </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">United States Securities and Exchange Commission </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">December 28, 2016 </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Page Three </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">The Company respectfully requests the Staff&#146;s assistance in completing the review of this response
letter. Please contact me at (212)&nbsp;479-6495 with any questions regarding the Company&#146;s responses to the Staff&#146;s comments or if you require further information. Thank you in advance for your attention to the above. </P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="top">Sincerely,</TD></TR>
<TR STYLE="font-size:1pt">
<TD HEIGHT="16"></TD></TR>
<TR STYLE="font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top" STYLE="BORDER-BOTTOM:1px solid #000000">/s/ Joshua A. Kaufman</TD></TR>
<TR STYLE="font-family:Times New Roman; font-size:10pt">
<TD VALIGN="bottom">Joshua A. Kaufman</TD></TR>
</TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>C<SMALL>OOLEY</SMALL> LLP </B></P> <P STYLE="font-size:12pt;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="4%" VALIGN="top" ALIGN="left">Cc:</TD>
<TD ALIGN="left" VALIGN="top">Ron Bentsur, UroGen Pharma Ltd. </TD></TR></TABLE>
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<TR>
<TD WIDTH="4%" VALIGN="top" ALIGN="left">&nbsp;&nbsp;&nbsp;&nbsp;</TD>
<TD ALIGN="left" VALIGN="top">Divakar Gupta, Cooley LLP </TD></TR></TABLE>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR>
<TD WIDTH="4%" VALIGN="top" ALIGN="left">&nbsp;&nbsp;&nbsp;&nbsp;</TD>
<TD ALIGN="left" VALIGN="top">Daniel I. Goldberg, Cooley LLP </TD></TR></TABLE>
 <p STYLE="margin-top:0pt;margin-bottom:0pt ; font-size:8pt">&nbsp;</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center">Cooley
LLP&nbsp;&nbsp;&nbsp;&nbsp;1114 Avenue of the Americas&nbsp;&nbsp;&nbsp;&nbsp;New York, NY&nbsp;&nbsp;&nbsp;&nbsp;10036 </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center">t: (212)
479-6000&nbsp;&nbsp;&nbsp;&nbsp;f: (212) 479-6275&nbsp;&nbsp;&nbsp;&nbsp;cooley.com </P>

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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
