<SEC-DOCUMENT>0001193125-17-005828.txt : 20170214
<SEC-HEADER>0001193125-17-005828.hdr.sgml : 20170214
<ACCEPTANCE-DATETIME>20170109170055
<PRIVATE-TO-PUBLIC>
ACCESSION NUMBER:		0001193125-17-005828
CONFORMED SUBMISSION TYPE:	CORRESP
PUBLIC DOCUMENT COUNT:		1
FILED AS OF DATE:		20170109

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			AMARIN CORP PLC\UK
		CENTRAL INDEX KEY:			0000897448
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				000000000
		STATE OF INCORPORATION:			X0
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		CORRESP

	BUSINESS ADDRESS:	
		STREET 1:		FIRST FLOOR, BLOCK 3, THE OVAL,
		STREET 2:		SHELBOURNE ROAD, BALLSBRIDGE
		CITY:			DUBLIN
		STATE:			L2
		ZIP:			00000
		BUSINESS PHONE:		353 1 6699 020

	MAIL ADDRESS:	
		STREET 1:		FIRST FLOOR, BLOCK 3, THE OVAL,
		STREET 2:		SHELBOURNE ROAD, BALLSBRIDGE
		CITY:			DUBLIN
		STATE:			L2
		ZIP:			00000

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	AMARIN PHARMACEUTICALS PLC
		DATE OF NAME CHANGE:	20000201

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	ETHICAL HOLDINGS PLC
		DATE OF NAME CHANGE:	19930322
</SEC-HEADER>
<DOCUMENT>
<TYPE>CORRESP
<SEQUENCE>1
<FILENAME>filename1.htm
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<TITLE>CORRESP</TITLE>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="right">January&nbsp;9, 2017 </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><U>VIA EDGAR AND FEDERAL EXPRESS </U></B></P> <P STYLE="margin-top:6pt; 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">Division of Corporation Finance </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, D.C. 20549 </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Attention: Jim B. Rosenberg, Senior Assistant Chief Accountant </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"><B>Re:</B></TD>
<TD ALIGN="left" VALIGN="top"><B>Amarin Corporation plc</B> </TD></TR></TABLE> <P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:8%; font-size:10pt; font-family:Times New Roman"><B>Form <FONT STYLE="white-space:nowrap">10-K</FONT> for the
fiscal year ended December&nbsp;31, 2015 </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:8%; font-size:10pt; font-family:Times New Roman"><B>Filed February&nbsp;25, 2016 </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:8%; font-size:10pt; font-family:Times New Roman"><B>File <FONT STYLE="white-space:nowrap">No.&nbsp;0-21392&nbsp;&nbsp;&nbsp;&nbsp;</FONT> </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Dear Mr.&nbsp;Rosenberg: </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 Amarin Corporation plc (the &#147;<U>Company</U>&#148;) in response to the comments of the staff of the Division of Corporation Finance (the &#147;<U>Staff</U>&#148;) of the Securities and Exchange Commission with respect to
the Company&#146;s Form <FONT STYLE="white-space:nowrap">10-K</FONT> for the fiscal year ended December&nbsp;31, 2015 filed on February&nbsp;25, 2016, as set forth in your letter dated December&nbsp;27, 2016 addressed to Michael Kalb, Chief
Financial Officer of the Company (the &#147;<U>Comment Letter</U>&#148;). </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:8%; font-size:10pt; font-family:Times New Roman">For reference purposes, the text of the Comment Letter has been
reproduced herein with a response below the numbered comment. For your convenience, we have italicized the reproduced Staff comment from the Comment Letter. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:8%; font-size:10pt; font-family:Times New Roman">In addition to submitting this letter via EDGAR, we are sending via Federal Express five (5)&nbsp;copies of this letter. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>Management&#146;s Discussion and Analysis </U></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>Research
and Development Expense, page 81 </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>1.</I></TD>
<TD ALIGN="left" VALIGN="top"><I>The disclosure states R&amp;D expense includes annual FDA fees for maintaining manufacturing sites and legal costs. Please explain to us how these expenses meet the definitions of research or development in ASC <FONT
STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">730-10-20</FONT></FONT> or otherwise comply with ASC <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">730-10-25</FONT></FONT> for classifying as R&amp;D expense. Separately
tell us the amount of these expenses incurred in each of the last three years and for the nine months ended September&nbsp;30, 2016.</I> </TD></TR></TABLE>
<P STYLE="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman">RESPONSE: </P> <P STYLE="margin-top:6pt; margin-bottom:0pt; margin-left:13%; font-size:10pt; font-family:Times New Roman">The Company
acknowledges the Staff&#146;s comment and respectfully submits that the annual FDA fees for maintaining manufacturing sites and legal costs included within R&amp;D expense meet the definitions of research and development as described in ASC 730, as
explained below, as well as provide the amount of such expenses for the requested periods. </P> <P STYLE="margin-top:6pt; margin-bottom:0pt; margin-left:13%; font-size:10pt; font-family:Times New Roman">The annual FDA fees for maintaining
manufacturing sites, included in R&amp;D expense, primarily represent fees for qualification of new suppliers, including increasing capacity capabilities, and fees for sites used for the manufacture of product used in the <FONT
STYLE="white-space:nowrap">REDUCE-IT</FONT> clinical outcomes study. Such costs aggregated approximately $1.1&nbsp;million for the nine months ended September&nbsp;30, 2016 and $0.9&nbsp;million, $0.8&nbsp;million, and $0.8&nbsp;million for the
years ended December&nbsp;31, 2015, 2014, and 2013, respectively. </P>

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 <P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:13%; font-size:10pt; font-family:Times New Roman">The legal costs included in R&amp;D expense primarily relate to certain portions of legal fees
incurred on matters related to global trademark, patent filings, and market exclusivity efforts as Vascepa is still under development in the U.S. for expanded indication and is not yet approved in any other markets. Such costs aggregated
approximately $1.4&nbsp;million for the nine months ended September&nbsp;30, 2016 and $1.7&nbsp;million, $0.3&nbsp;million, and $1.6&nbsp;million for the years ended December&nbsp;31, 2015, 2014 and 2013, respectively. Based on the guidance of ASC <FONT
STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">730-10-20</FONT></FONT> and the immateriality of such amounts, the Company will prospectively classify such costs as selling, general and administrative expense. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>Notes to Consolidated Financial Statements </U></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>Note 17:
Development, Commercialization and Supply Agreement, page <FONT STYLE="white-space:nowrap">F-43</FONT></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>2.</I></TD>
<TD ALIGN="left" VALIGN="top"><I>In the second paragraph on page <FONT STYLE="white-space:nowrap">F-44</FONT> you indicate that you are entitled to receive up to $154.0&nbsp;million in regulatory and sales-based milestone payments under your DCS
Agreement with Eddingpharm (Asia) Macao Commercial Offshore Limited. At the top of page 6 you disclose that you are also entitled to receive development milestones. Please reconcile this difference for us and represent to us that you will correct
this inconsistency in future filings. In addition, tell us your consideration for disclosing each milestone and its related consideration as required by ASC <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap"><FONT
STYLE="white-space:nowrap">605-28-50-2b.</FONT></FONT></FONT></I> </TD></TR></TABLE> <P STYLE="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman">RESPONSE: </P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; margin-left:13%; font-size:10pt; font-family:Times New Roman">The Company acknowledges the Staff&#146;s comment and confirms that it will correct the inconsistency in future filings, in a manner
consistent with the Staff&#146;s comment. </P> <P STYLE="margin-top:6pt; margin-bottom:0pt; margin-left:13%; font-size:10pt; font-family:Times New Roman">It was not the Company&#146;s intent to imply that the $154.0&nbsp;million related to different
categories of milestone payments as disclosed in the two distinct parts of the Form <FONT STYLE="white-space:nowrap">10-K,</FONT> and such difference in disclosure was simply an unintended inconsistency in terminology. The Development,
Commercialization and Supply Agreement dated February&nbsp;26, 2015, by and between Amarin Pharmaceuticals Ireland Limited, Amarin Pharma, Inc. and Eddingpharm (Asia) Macao Commercial Offshore Limited (&#147;Eddingpharm&#148;) (the &#147;DCS
Agreement&#148;) (Exhibit Number 10.57 of the Form <FONT STYLE="white-space:nowrap">10-K</FONT> for the fiscal year ended December&nbsp;31, 2015 filed on February&nbsp;25, 2016) includes the terms &#147;regulatory milestones&#148; and &#147;sales
based milestones.&#148; Included within the &#147;regulatory milestones&#148; is a requirement for the Company to provide <FONT STYLE="white-space:nowrap">on-going</FONT> development support; however, there is no specific reference to
&#147;development milestones.&#148; For consistency purposes, the Company advises the Staff that it will correct this inconsistency by referring to the aggregate milestone payments under the DCS Agreement as &#147;regulatory and sales-based
milestone payments&#148; in all references within future periodic filings.&nbsp;&nbsp;&nbsp;&nbsp; </P> <P STYLE="margin-top:6pt; margin-bottom:0pt; margin-left:13%; font-size:10pt; font-family:Times New Roman">The Company also respectfully
acknowledges the Staff&#146;s comment to disclose a description of each individual milestone and its related contingent consideration as required by ASC
<FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">605-28-50-2b.</FONT></FONT></FONT> In applying the guidance in </P>

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 <P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:13%; font-size:10pt; font-family:Times New Roman">
ASC <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">605-28-50-2b,</FONT></FONT></FONT> the Company considered which individual milestones, if
any, would be material from a disclosure perspective. In making this assessment, among the factors the Company evaluated were the individual amount of each payment in relation to the Company&#146;s financial results and the overall economics of the
collaboration, the relative inability to predict the likely timing of achievement of milestones prior to clarification of the clinical development plan for Vascepa in China by the China Food and Drug Administration, the scientific, clinical,
regulatory, commercial and other risks that must be overcome to achieve the respective milestone, potential interpretation by investors and potential commercial harm to the Company and Eddingpharm if such milestone payment details were made
available to competitors. The Company believes that the description of milestones and the range of amounts and total for each category comply with the requirements in all material respects. In light of the foregoing, the Company proposes to revise
the disclosure consistent with the sample set forth in Exhibit A attached hereto (marked for example purposes to show changes against the Form <FONT STYLE="white-space:nowrap">10-K</FONT> for the fiscal year ended December&nbsp;31, 2015 filed on
February&nbsp;25, 2016). </P> <P STYLE="margin-top:6pt; margin-bottom:0pt; margin-left:13%; font-size:10pt; font-family:Times New Roman">The Company respectfully directs the Staff&#146;s attention to Note 17 of the Form <FONT
STYLE="white-space:nowrap">10-K</FONT> for the fiscal year ended December&nbsp;31, 2015 filed on February&nbsp;25, 2016 where the Company includes a significant amount of disclosure about the key terms of its DCS Agreement with Eddingpharm,
including the aggregate amount of remaining potential milestone payments as of <FONT STYLE="white-space:nowrap">year-end</FONT> and general triggering events. To enhance its existing disclosure, the Company proposes to add, in its future periodic
filings, additional information about its potential milestone payments by providing a breakdown and range of such potential future milestone payments into the following categories: (1)&nbsp;regulatory milestones; and (2)&nbsp;sales-based milestones.
By aggregating the potential milestones into the aforementioned categories, together with the existing description of the related milestone triggering events, the Company believes it is providing investors with all material relevant information as
well as an understanding of the scope of the collaboration, as required by ASC <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">605-28-50-2.</FONT></FONT></FONT> Such categorization of milestone
payments allows investors to differentiate amounts that are at risk prior to regulatory approval from amounts that are at risk as to the successful commercialization of the product. </P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; margin-left:13%; font-size:10pt; font-family:Times New Roman">Accordingly, the Company proposes to enhance its disclosure regarding milestones and related contingent consideration in its future periodic
filings, consistent with the sample set forth in Exhibit A hereto (marked to show changes against the Form <FONT STYLE="white-space:nowrap">10-K</FONT> for the fiscal year ended December&nbsp;31, 2015 filed on February&nbsp;25, 2016). </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center">******* </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The Company acknowledges that: </P>
<P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="5%">&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>
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<TD WIDTH="5%">&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>

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<TD WIDTH="5%">&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 proceedings initiated by the Commission or any person under the federal securities laws of the United States. </TD></TR></TABLE>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">If you require additional information, please telephone the undersigned at (908) <FONT STYLE="white-space:nowrap">719-1315.</FONT> </P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><DIV ALIGN="right">
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<TD VALIGN="top">Sincerely,</TD></TR>
<TR STYLE="font-size:1pt">
<TD HEIGHT="16"></TD></TR>
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<TD VALIGN="top"> <P STYLE="margin-top:0pt; margin-bottom:1pt; border-bottom:1px solid #000000; font-size:10pt; font-family:Times New Roman">/s/ Michael W. Kalb</P></TD></TR>
<TR STYLE="font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top">Michael W. Kalb</TD></TR>
<TR STYLE="font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top">Senior Vice President&nbsp;&amp; Chief Financial Officer</TD></TR>
</TABLE></DIV> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Enclosures </P> <P STYLE="font-size:6pt;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">John F. Thero, <I>Amarin Corporation plc</I> </TD></TR></TABLE> <P STYLE="margin-top:0pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">Joseph T. Kennedy, <I>Amarin Corporation plc</I>
</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">Michael H. Bison, <I>Goodwin Procter LLP</I> </P>

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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Exhibit A </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Example of Proposed Disclosure in Notes to Consolidated Financial Statements, </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B><I>&#147;Note 17: Development, Commercialization and Supply Agreement&#148; </I></B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>(marked to show changes against the Form 10-K) </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">On February&nbsp;26, 2015, the Company entered into a Development, Commercialization and Supply Agreement (the &#147;DCS Agreement&#148;) with Eddingpharm
(Asia) Macao Commercial Offshore Limited (&#147;Eddingpharm&#148;) related to the development and commercialization of Vascepa in Mainland China, Hong Kong, Macau and Taiwan, or the China Territory. Under the terms of the DCS Agreement, the Company
granted to Eddingpharm an exclusive (including as to the Company) license with right to sublicense to develop and commercialize Vascepa in the China Territory for uses that are currently commercialized and under development by the Company based on
the Company&#146;s MARINE, ANCHOR and ongoing REDUCE-IT clinical trials of Vascepa. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Under the DCS Agreement, Eddingpharm will be solely responsible for
development and commercialization activities in the China Territory and associated expenses. The Company will provide development assistance and be responsible for supplying finished and later bulk drug product at defined prices under negotiated
terms. The Company will retain all Vascepa manufacturing rights. Eddingpharm has agreed to certain restrictions regarding the commercialization of competitive products globally and the Company has agreed to certain restrictions regarding the
commercialization of competitive products in the China Territory. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The Company and Eddingpharm agreed to form a joint development committee to oversee
regulatory and development activities for Vascepa in the China Territory in accordance with a negotiated development plan and to form a separate joint commercialization committee to oversee Vascepa commercialization activities in the China
Territory. Development costs will be paid by Eddingpharm to the extent such costs are incurred in connection with the negotiated development plan or otherwise incurred by Eddingpharm. Eddingpharm will be responsible for preparing and filing
regulatory applications in all countries of the China Territory at Eddingpharm&#146;s cost with the Company&#146;s assistance. The DCS Agreement also contains customary provisions regarding indemnification, packaging, record keeping, audit rights,
reporting obligations, and representations and warranties that are customary for an arrangement of this type. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The term of the DCS Agreement expires, on a
product-by-product basis, upon the later of (i)&nbsp;the date on which such product is no longer covered by a valid claim under a licensed patent in the China Territory, or (ii)&nbsp;the twelfth (12th)&nbsp;anniversary of the first commercial sale
of such product in Mainland China. The DCS Agreement may be terminated by either party in the event of a bankruptcy of the other party and for material breach, subject to customary cure periods. In addition, at any time following the third
anniversary of the first commercial sale of a product in Mainland China, Eddingpharm has the right to terminate the DCS Agreement for convenience with twelve months&#146; prior notice. Neither party may assign or transfer the DCS Agreement without
the prior consent of the other party, provided that the Company may assign the DCS Agreement in the event of a change of control transaction. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Upon
closing of the DCS Agreement, the Company received a non-refundable $15.0 million up-front payment, which it will recognize as revenue over the estimated period in which the Company is required to provide initial and on-going regulatory and
development support and clinical supply for obtaining regulatory approvals in the China Territory and through the estimated period in which the Company is required to provide commercial supply, which is currently estimated to be a period of
approximately 16 years. Consequently, the Company recognized $0.8 million of the up-front payment as licensing revenue during the year ended December&nbsp;31, 2015 and recorded $14.2 million as deferred revenue as of December&nbsp;31, 2015. </P>

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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In addition to the non-refundable, up-front payment, the Company is entitled to receive certain regulatory and
sales-based milestone payments of up to an additional $154.0 million as well as tiered double-digit percentage royalties on net sales of Vascepa in the China Territory escalating to the high teens. The regulatory milestone events, relate to the
submission and approval of certain applications to the applicable regulatory authority, such as a clinical trial application, clinical trial exemption, or import drug license application. <U STYLE="border-bottom:1pt double; padding-bottom:1pt">The
amounts to be received upon achievement of the regulatory milestone events for submission and approval for three indications range from $1.0 million to $15.0 million, for a total of $34.0 million.</U> The sales-based milestone events, occur when
annual aggregate net sales of Vascepa in the territory equals or exceeds certain specified thresholds<U STYLE="border-bottom:1pt double; padding-bottom:1pt">, and range from $5.0 million to $50.0 million for a total of $120.0 million</U>. Each such
milestone payment shall be payable only once regardless of how many times the sales milestone event is achieved. Each such milestone payment is non-refundable and non-creditable against any other milestone payments. The Company recognizes contingent
consideration from activities that is earned upon the achievement of a substantive milestone in the period in which the milestone is achieved. <U STYLE="border-bottom:1pt double; padding-bottom:1pt">Due to uncertainties regarding the timing and
scope of clinical trials and regulatory approval for Vascepa in the China Territory, the Company at this time cannot accurately forecast the timing at which these milestones will be earned, if at all.</U> </P>
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