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<p style="margin: 0pt; text-align: center; font-family: Times New Roman, Times, serif; font-size: 18pt;"><b>UNITED STATES</b></p>

<p style="margin: 0pt; text-align: center; font-family: Times New Roman, Times, serif; font-size: 18pt;"><b>SECURITIES AND EXCHANGE COMMISSION</b></p>

<p style="margin: 0pt; text-align: center; font-family: Times New Roman, Times, serif; font-size: 10pt;"><b>WASHINGTON, D.C. 20549 </b></p>

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<p style="margin: 0pt; text-align: center; font-family: Times New Roman, Times, serif; font-size: 18pt;"><b>FORM 8-K </b></p>

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<p style="margin: 0pt; text-align: center; font-family: Times New Roman, Times, serif; font-size: 10pt;"><b>CURRENT REPORT </b></p>

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<p style="margin: 0pt; text-align: center; font-family: Times New Roman, Times, serif; font-size: 10pt;"><b>Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 </b></p>

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<p style="margin: 0pt; text-align: center; font-family: Times New Roman, Times, serif; font-size: 10pt;"><b>Date of Report (Date of earliest eve</b><font style="font-family: Times New Roman, Times, serif; font-size: 10pt;"><b>nt reported):&nbsp;October 18</b><b>, 2016 (October 13, 2016)</b></font></p>

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<p style="margin: 0pt; text-align: center; font-family: Times New Roman, Times, serif; font-size: 24pt;"><b>KEMPHARM, INC.</b></p>

<p style="margin: 0pt; text-align: center; font-family: Times New Roman, Times, serif; font-size: 10pt;"><b>(Exact name of Registrant as Specified in Its Charter) </b></p>

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			<p style="margin: 0pt; text-align: center; font-family: Times New Roman, Times, serif; font-size: 10pt;"><b>Delaware</b></p>
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			<p style="margin: 0pt; text-align: center; font-family: Times New Roman, Times, serif; font-size: 10pt;"><b>001-36913</b></p>
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			<p style="margin: 0pt; text-align: center; font-family: Times New Roman, Times, serif; font-size: 10pt;"><b>20-5894398</b></p>
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			<p style="margin: 0pt; text-align: center; font-family: Times New Roman, Times, serif; font-size: 10pt;"><b>(State or Other Jurisdiction</b></p>

			<p style="margin: 0pt; text-align: center; font-family: Times New Roman, Times, serif; font-size: 10pt;"><b>of Incorporation)</b></p>
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			<p style="margin: 0pt; text-align: center; font-family: Times New Roman, Times, serif; font-size: 10pt;"><b>Identification No.)</b></p>
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			<p style="margin: 0pt; text-align: center; font-family: Times New Roman, Times, serif; font-size: 10pt;"><b>2500 Crosspark Road, Suite E126</b></p>

			<p style="margin: 0pt; text-align: center; font-family: Times New Roman, Times, serif; font-size: 10pt;"><b>Coralville, IA</b></p>
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			<p style="margin: 0pt; text-align: center; font-family: Times New Roman, Times, serif; font-size: 10pt;"><b>52241</b></p>
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			<p style="margin: 0pt; text-align: center; font-family: Times New Roman, Times, serif; font-size: 10pt;"><b>(Address of Principal Executive Offices)</b></p>
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			<p style="margin: 0pt; text-align: center; font-family: Times New Roman, Times, serif; font-size: 10pt;">(Zip Code)</p>
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<p style="margin: 0pt; text-align: center; font-family: Times New Roman, Times, serif; font-size: 10pt;"><b>Registrant<font style="font-family: Times New Roman, Times, serif; font-size: 10pt;">&rsquo;s Telephone Number, Including Area Code: </font></b><font style="font-family: Times New Roman, Times, serif; font-size: 10pt;"><b>(319) 665-2575</b></font></p>

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<p style="margin: 0pt; text-align: center; font-family: Times New Roman, Times, serif; font-size: 10pt;"><b>Not Applicable </b></p>

<p style="margin: 0pt; text-align: center; font-family: Times New Roman, Times, serif; font-size: 10pt;"><b>(Former Name or Former Address, if Changed Since Last Report) </b></p>

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<p style="margin: 0pt; text-align: left; font-family: Times New Roman, Times, serif; font-size: 10pt;">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 Instructions A.2. below):</p>

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<p style="margin: 0pt; text-align: left; font-family: Times New Roman, Times, serif; font-size: 10pt;"><b>Item 7</b><font style="font-family: Times New Roman, Times, serif; font-size: 10pt;"><b>.01</b><b>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</b><b>Regulation FD Disclosure</b><b>.</b></font></p>

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<p style="margin: 0pt; text-align: justify; font-family: Times New Roman, Times, serif; font-size: 10pt;">On October 18, 2016,<font style="font-family: Times New Roman, Times, serif; font-size: 10pt;">&nbsp;KemPharm, Inc., a Delaware corporation (&ldquo;KemPharm&rdquo;), issued a press release announcing its entry into a License Agreement (the &ldquo;License Agreement&rdquo;) with Acura Pharmaceuticals, Inc., a New York corporation (&ldquo;Acura&rdquo;). A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K. The information set forth in this Item 7.01 and contained in the press release furnished as Exhibit 99.1 shall not be deemed &ldquo;filed&rdquo; for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the &ldquo;Exchange Act&rdquo;), and is not incorporated by reference into any of KemPharm&rsquo;s filings under the Securities Act of 1933, as amended (the &ldquo;Securities Act&rdquo;), or the Exchange Act, whether made before or after the date hereof, except as shall be expressly set forth by specific reference in any such filing.</font></p>

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<p style="margin: 0pt; text-align: left; font-family: Times New Roman, Times, serif; font-size: 10pt;"><b>Item 8.01&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Other Events.</b></p>

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<p style="margin: 0pt; text-align: justify; font-family: Times New Roman, Times, serif; font-size: 10pt;">As described above, on October 13, 2016, KemPharm entered into the License Agreement with Acura<font style="font-family: Times New Roman, Times, serif; font-size: 10pt;"> </font><font style="font-family: Times New Roman, Times, serif; font-size: 10pt;">whereby Acura will provide its proprietary Aversion Technology to KemPharm to use with its current and in-development immediate release (&ldquo;IR&rdquo;) opioid product candidates. Aversion Technology is a patented composition of commonly used active and inactive pharmaceutical ingredients providing abuse deterrent features and benefits for orally administered pharmaceutical drug products. </font></p>

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<p style="margin: 0pt; text-align: justify; font-family: Times New Roman, Times, serif; font-size: 10pt;">The License Agreement provides for an upfront cash payment of $3.5 million to Acura&nbsp;at execution and grants KemPharm development and commercialization rights for up to three IR product candidates containing two of KemPharm<font style="font-family: Times New Roman, Times, serif; font-size: 10pt;">&rsquo;s opioid prodrugs. Additional payments are provided in the License&nbsp;Agreement&nbsp;should KemPharm exercise its option to use Acura&rsquo;s Aversion Technology with more than the three products. Acura is eligible to receive a royalty at a low single-digit rate based on commercial sales by KemPharm of all products developed under the License Agreement. KemPharm will solely own the intellectual property resulting from any new product development. </font></p>

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<p style="margin: 0pt; text-align: justify; font-family: Times New Roman, Times, serif; font-size: 10pt;"><b>Caution Concerning Forward Looking Statements</b></p>

<p style="margin: 0pt; text-align: justify; font-family: Times New Roman, Times, serif; font-size: 10pt;"><b>&nbsp;</b></p>

<p style="margin: 0pt; text-align: left; font-family: Times New Roman, Times, serif; font-size: 10pt;">This Current Report on Form 8-K may contain forward-looking statements made by KemPharm in reliance upon the safe harbor provisions of Section 27A of the Securities and Section 21E of the Exchange Act. Forward-looking statements include all <font style="font-family: Times New Roman, Times, serif; font-size: 10pt;">statements that do not relate solely to historical or current facts, and can be identified by the use of words such as &ldquo;may,&rdquo; &ldquo;will,&rdquo; &ldquo;expect,&rdquo; &ldquo;project,&rdquo; &ldquo;estimate,&rdquo; &ldquo;anticipate,&rdquo; &ldquo;plan,&rdquo; &ldquo;believe,&rdquo; &ldquo;potential,&rdquo; &ldquo;should,&rdquo; &ldquo;continue&rdquo; or the negative versions of those words or other comparable words. These forward-looking statements include statements regarding the potential development of any product candidates under the License Agreement, the expected features and characteristics of KemPharm&rsquo;s current and in-development opioid product candidates, including those potentially developed under the License Agreement, and any payments to be made by KemPharm under the License Agreement. These forward-looking statements are not guarantees of future actions or performance. These forward-looking statements are based on information currently available to KemPharm and its current plans or expectations, and are subject to a number of uncertainties and risks that could significantly affect current plans. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: KemPharm&#39;s financial resources and whether they will be sufficient to meet KemPharm&#39;s business objectives and operational requirements; results of earlier studies and trials may not be predictive of future clinical trial results; the protection and market exclusivity provided by KemPharm&#39;s intellectual property; risks related to the drug discovery and the regulatory approval process; the impact of competitive products and technological changes; and the FDA approval process under the Section 505(b)(2) regulatory pathway, including without limitation any timelines for related approval. KemPharm&#39;s forward-looking statements also involve assumptions that, if they prove incorrect, would cause its results to differ materially from those expressed or implied by such forward-looking statements. These and other risks concerning KemPharm&rsquo;s business are described in additional detail in KemPharm&#39;s Quarterly Report on Form 10-Q for the quarter ended June 30, 2016, and KemPharm&rsquo;s other Periodic and Current Reports filed with the Securities and Exchange Commission. KemPharm is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.</font></p>

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<p style="margin: 0pt; text-align: left; font-family: Times New Roman, Times, serif; font-size: 10pt;"><b>Item 9.01&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </b><font style="font-family: Times New Roman, Times, serif; font-size: 10pt;"><b>Financial Statements and Exhibits.</b></font></p>

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			<p style="text-align: left; font-family: Times New Roman, Times, serif; font-size: 10pt; margin-top: 0pt; margin-right: 0pt; margin-bottom: 0pt;">(d)</p>
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			<p style="margin: 0pt; text-align: center; font-family: Times New Roman, Times, serif; font-size: 10pt;">Description</p>
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			<p style="margin: 0pt; text-align: center; font-family: Times New Roman, Times, serif; font-size: 10pt;">99.1</p>

			<p style="margin: 0pt; text-align: center; font-family: Times New Roman, Times, serif; font-size: 10pt;">&nbsp;</p>
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			<p style="margin: 0pt; text-align: left; font-family: Times New Roman, Times, serif; font-size: 10pt;">&nbsp;</p>
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			<td style="width: 87.5%; vertical-align: top; border-bottom-color: rgb(0, 0, 0); border-bottom-width: 1px; border-bottom-style: none;">
			<p style="margin: 0pt; text-align: justify; font-family: Times New Roman, Times, serif; font-size: 10pt;">Press Release titled <font style="font-family: Times New Roman, Times, serif; font-size: 10pt;">&ldquo;</font>KemPharm Announces Licensing Agreement with Acura Pharmaceuticals for Aversion&reg; Abuse-Deterrent Technology&quot;<font style="font-family: Times New Roman, Times, serif; font-size: 10pt;">&nbsp;dated&nbsp;October 18, 2016.</font></p>
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<p style="font-family: Times New Roman, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</p>

<div id="PGBK" style="width: 100%; margin-right: 0pt; margin-left: 0pt;">
<div id="PGNUM" style="width: 100%; text-align: center;">&nbsp;</div>

<hr style="border: currentColor; border-image: none; width: 100%; height: 2px; color: rgb(0, 0, 0); page-break-after: always; background-color: rgb(0, 0, 0);">
<div id="PGHDR" style="width: 100%; text-align: left;">&nbsp;</div>
</div>

<p style="margin: 0pt; text-align: left; text-indent: 36pt; font-family: Times New Roman, Times, serif; font-size: 10pt;">&nbsp;</p>

<p style="margin: 0pt; text-align: center; font-family: Times New Roman, Times, serif; font-size: 10pt;"><b>SIGNATURES</b></p>

<p style="font-family: Times New Roman, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</p>

<p style="margin: 0pt; text-align: justify; text-indent: 18pt; font-family: Times New Roman, Times, serif; font-size: 10pt;">Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.</p>

<p style="margin: 0pt; text-align: left; font-family: Times New Roman, Times, serif; font-size: 10pt;">&nbsp;</p>

<table border="0" cellpadding="0" cellspacing="0" id="TBL23" style="width: 100%; text-indent: 0px; font-family: Times New Roman, Times, serif; font-size: 10pt;">

		<tr>
			<td style="width: 45.4%; vertical-align: top;">
			<p style="margin: 0pt; text-align: left; font-family: Times New Roman, Times, serif; font-size: 10pt;">&nbsp;</p>
			</td>
			<td style="width: 5%; vertical-align: bottom;">
			<p style="margin: 0pt; text-align: left; font-family: Times New Roman, Times, serif; font-size: 10pt;">&nbsp;</p>
			</td>
			<td colspan="2" style="width: 49.6%; vertical-align: bottom;">
			<p style="margin: 0pt; text-align: left; font-family: Times New Roman, Times, serif; font-size: 10pt;"><b>K</b><font style="font-family: Times New Roman, Times, serif; font-size: 10pt;"><b>EM</b></font><font style="font-family: Times New Roman, Times, serif; font-size: 10pt;"><b>P</b></font><font style="font-family: Times New Roman, Times, serif; font-size: 10pt;"><b>HARM</b></font><font style="font-family: Times New Roman, Times, serif; font-size: 10pt;"><b>, I</b></font><font style="font-family: Times New Roman, Times, serif; font-size: 10pt;"><b>NC</b></font><font style="font-family: Times New Roman, Times, serif; font-size: 10pt;"><b>.</b></font></p>
			</td>
		</tr>
		<tr>
			<td style="width: 45.4%; vertical-align: middle;">
			<p style="margin: 0pt; text-align: left; font-family: Times New Roman, Times, serif; font-size: 10pt;">&nbsp;</p>
			</td>
			<td style="width: 5%; vertical-align: bottom;">
			<p style="margin: 0pt; text-align: left; font-family: Times New Roman, Times, serif; font-size: 10pt;">&nbsp;</p>
			</td>
			<td style="width: 3.2%; vertical-align: bottom;">
			<p style="margin: 0pt; text-align: left; font-family: Times New Roman, Times, serif; font-size: 10pt;">&nbsp;</p>
			</td>
			<td style="width: 46.4%; vertical-align: bottom;">
			<p style="margin: 0pt; text-align: left; font-family: Times New Roman, Times, serif; font-size: 10pt;">&nbsp;</p>
			</td>
		</tr>
		<tr>
			<td style="width: 45.4%; vertical-align: bottom;">
			<p style="margin: 0pt; text-align: left; font-family: Times New Roman, Times, serif; font-size: 10pt;">Date:&nbsp;October 18<font style="font-family: Times New Roman, Times, serif; font-size: 10pt;">, 2016</font></p>
			</td>
			<td style="width: 5%; vertical-align: bottom;">
			<p style="margin: 0pt; text-align: left; font-family: Times New Roman, Times, serif; font-size: 10pt;">&nbsp;</p>
			</td>
			<td style="width: 3.2%; vertical-align: top;">
			<p style="margin: 0pt; text-align: left; font-family: Times New Roman, Times, serif; font-size: 10pt;">By:</p>
			</td>
			<td style="width: 46.4%; vertical-align: bottom; border-bottom-color: rgb(0, 0, 0); border-bottom-width: 1px; border-bottom-style: solid;">
			<p style="margin: 0pt; text-align: left; font-family: Times New Roman, Times, serif; font-size: 10pt;">/s/ R. LaDuane Clifton</p>
			</td>
		</tr>
		<tr>
			<td style="width: 45.4%; vertical-align: bottom;">
			<p style="margin: 0pt; text-align: left; font-family: Times New Roman, Times, serif; font-size: 10pt;">&nbsp;</p>
			</td>
			<td style="width: 5%; vertical-align: bottom;">
			<p style="margin: 0pt; text-align: left; font-family: Times New Roman, Times, serif; font-size: 10pt;">&nbsp;</p>
			</td>
			<td style="width: 3.2%; vertical-align: middle;">
			<p style="margin: 0pt; text-align: left; font-family: Times New Roman, Times, serif; font-size: 10pt;"><b>&nbsp;</b></p>
			</td>
			<td style="width: 46.4%; vertical-align: bottom; border-bottom-color: rgb(0, 0, 0); border-bottom-width: 1px; border-bottom-style: none;">
			<p style="margin: 0pt; text-align: left; font-family: Times New Roman, Times, serif; font-size: 10pt;">R. LaDuane Clifton</p>
			</td>
		</tr>
		<tr>
			<td style="width: 45.4%; vertical-align: bottom;">
			<p style="margin: 0pt; text-align: left; font-family: Times New Roman, Times, serif; font-size: 10pt;">&nbsp;</p>
			</td>
			<td style="width: 5%; vertical-align: bottom;">
			<p style="margin: 0pt; text-align: left; font-family: Times New Roman, Times, serif; font-size: 10pt;">&nbsp;</p>
			</td>
			<td style="width: 3.2%; vertical-align: bottom;">
			<p style="margin: 0pt; text-align: left; font-family: Times New Roman, Times, serif; font-size: 10pt;"><b>&nbsp;</b></p>
			</td>
			<td style="width: 46.4%; vertical-align: bottom;">
			<p style="margin: 0pt; text-align: left; font-family: Times New Roman, Times, serif; font-size: 10pt;">Chief Financial<font style="font-family: Times New Roman, Times, serif; font-size: 10pt;"> Officer</font></p>
			</td>
		</tr>

</table>

<p style="font-family: Times New Roman, Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</p>

<div id="PGBK" style="width: 100%; margin-right: 0pt; margin-left: 0pt;">
<div id="PGNUM" style="width: 100%; text-align: center;">&nbsp;</div>

<hr style="border: currentColor; border-image: none; width: 100%; height: 2px; color: rgb(0, 0, 0); page-break-after: always; background-color: rgb(0, 0, 0);">
<div id="PGHDR" style="width: 100%; text-align: left;">&nbsp;</div>
</div>

<p style="margin: 0pt; text-align: left; font-family: Times New Roman, Times, serif; font-size: 10pt;">&nbsp;</p>

<p style="margin: 0pt; text-align: center; font-family: Times New Roman, Times, serif; font-size: 10pt;"><b>Exhibit <font style="font-family: Times New Roman, Times, serif; font-size: 10pt;">Index</font></b></p>

<p style="margin: 0pt; text-align: left; font-family: Times New Roman, Times, serif; font-size: 10pt;">&nbsp;</p>

<table border="0" cellpadding="0" cellspacing="0" id="TBL24" style="width: 100%; text-indent: 0px; font-family: Times New Roman, Times, serif; font-size: 10pt;">

		<tr>
			<td style="width: 10.6%; vertical-align: bottom; border-bottom-color: rgb(0, 0, 0); border-bottom-width: 1px; border-bottom-style: solid;">
			<p style="margin: 0pt; text-align: center; font-family: Times New Roman, Times, serif; font-size: 10pt;">Exhibit<font style="font-family: Times New Roman, Times, serif; font-size: 10pt;">&nbsp;No.</font></p>
			</td>
			<td style="width: 1.9%; vertical-align: bottom;">
			<p style="margin: 0pt; text-align: left; font-family: Times New Roman, Times, serif; font-size: 10pt;">&nbsp;</p>
			</td>
			<td style="width: 87.5%; vertical-align: bottom; border-bottom-color: rgb(0, 0, 0); border-bottom-width: 1px; border-bottom-style: solid;">
			<p style="margin: 0pt; text-align: center; font-family: Times New Roman, Times, serif; font-size: 10pt;">Description</p>
			</td>
		</tr>
		<tr>
			<td style="width: 10.6%; vertical-align: top; border-bottom-color: rgb(0, 0, 0); border-bottom-width: 1px; border-bottom-style: none;">
			<p style="margin: 0pt; text-align: center; font-family: Times New Roman, Times, serif; font-size: 10pt;">99.1</p>

			<p style="margin: 0pt; text-align: center; font-family: Times New Roman, Times, serif; font-size: 10pt;">&nbsp;</p>
			</td>
			<td style="width: 1.9%; vertical-align: bottom;">
			<p style="margin: 0pt; text-align: left; font-family: Times New Roman, Times, serif; font-size: 10pt;">&nbsp;</p>
			</td>
			<td style="width: 87.5%; vertical-align: top; border-bottom-color: rgb(0, 0, 0); border-bottom-width: 1px; border-bottom-style: none;">
			<p style="margin: 0pt; text-align: justify; font-family: Times New Roman, Times, serif; font-size: 10pt;">Press Release titled &ldquo;KemPharm Announces Licensing Agreement with Acura Pharmaceuticals for Aversion&reg; Abuse-Deterrent Technology<font style="font-family: Times New Roman, Times, serif; font-size: 10pt;">&rdquo; dated&nbsp;October 18, 2016.</font></p>
			</td>
		</tr>

</table>

<p style="margin: 0pt; text-align: left; font-family: Times New Roman, Times, serif; font-size: 10pt;">&nbsp;</p>
</body></html>
[{"type": "8-K", "sequence": "1", "filename": "kmph20161017_8k.htm", "description": "FORM 8-K", "secsgml_size_bytes": 33308}]
{"company-data": {"conformed-name": "KEMPHARM, INC", "cik": "0001434647", "assigned-sic": "2834", "irs-number": "205894398", "state-of-incorporation": "DE", "fiscal-year-end": "1231"}, "filing-values": {"form-type": "8-K", "act": "34", "file-number": "001-36913", "film-number": "161939805"}, "business-address": {"street1": "2500 CROSSPARK ROAD, SUITE E126", "city": "CORALVILLE", "state": "IA", "zip": "52241", "phone": "319-665-2575"}, "mail-address": {"street1": "2500 CROSSPARK ROAD, SUITE E126", "city": "CORALVILLE", "state": "IA", "zip": "52241"}, "former-company": {"former-conformed-name": "KEMPHARM INC", "date-changed": "20080507"}}
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest eve
nt reported): October 18
, 2016 (October 13, 2016)
KEMPHARM, INC.
(Exact name of Registrant as Specified in Its Charter)
Delaware
001-36913
20-5894398
(State or Other Jurisdiction
of Incorporation)
(Commission File Number)
(IRS Employer
Identification No.)
2500 Crosspark Road, Suite E126
Coralville, IA
52241
(Address of Principal Executive Offices)
(Zip Code)
Registrant
's Telephone Number, Including Area Code:
(319) 665-2575
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
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 Instructions A.2. below):
☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 7
.01
Regulation FD Disclosure
.
On October 18, 2016,
KemPharm, Inc., a Delaware corporation ("KemPharm"), issued a press release announcing its entry into a License Agreement (the "License Agreement") with Acura Pharmaceuticals, Inc., a New York corporation ("Acura"). A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K. The information set forth in this Item 7.01 and contained in the press release furnished as Exhibit 99.1 shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), and is not incorporated by reference into any of KemPharm's filings under the Securities Act of 1933, as amended (the "Securities Act"), or the Exchange Act, whether made before or after the date hereof, except as shall be expressly set forth by specific reference in any such filing.
Item 8.01          Other Events.
As described above, on October 13, 2016, KemPharm entered into the License Agreement with Acura
whereby Acura will provide its proprietary Aversion Technology to KemPharm to use with its current and in-development immediate release ("IR") opioid product candidates. Aversion Technology is a patented composition of commonly used active and inactive pharmaceutical ingredients providing abuse deterrent features and benefits for orally administered pharmaceutical drug products.
The License Agreement provides for an upfront cash payment of $3.5 million to Acura at execution and grants KemPharm development and commercialization rights for up to three IR product candidates containing two of KemPharm
's opioid prodrugs. Additional payments are provided in the License Agreement should KemPharm exercise its option to use Acura's Aversion Technology with more than the three products. Acura is eligible to receive a royalty at a low single-digit rate based on commercial sales by KemPharm of all products developed under the License Agreement. KemPharm will solely own the intellectual property resulting from any new product development.
Caution Concerning Forward Looking Statements
This Current Report on Form 8-K may contain forward-looking statements made by KemPharm in reliance upon the safe harbor provisions of Section 27A of the Securities and Section 21E of the Exchange Act. Forward-looking statements include all
statements that do not relate solely to historical or current facts, and can be identified by the use of words such as "may," "will," "expect," "project," "estimate," "anticipate," "plan," "believe," "potential," "should," "continue" or the negative versions of those words or other comparable words. These forward-looking statements include statements regarding the potential development of any product candidates under the License Agreement, the expected features and characteristics of KemPharm's current and in-development opioid product candidates, including those potentially developed under the License Agreement, and any payments to be made by KemPharm under the License Agreement. These forward-looking statements are not guarantees of future actions or performance. These forward-looking statements are based on information currently available to KemPharm and its current plans or expectations, and are subject to a number of uncertainties and risks that could significantly affect current plans. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: KemPharm's financial resources and whether they will be sufficient to meet KemPharm's business objectives and operational requirements; results of earlier studies and trials may not be predictive of future clinical trial results; the protection and market exclusivity provided by KemPharm's intellectual property; risks related to the drug discovery and the regulatory approval process; the impact of competitive products and technological changes; and the FDA approval process under the Section 505(b)(2) regulatory pathway, including without limitation any timelines for related approval. KemPharm's forward-looking statements also involve assumptions that, if they prove incorrect, would cause its results to differ materially from those expressed or implied by such forward-looking statements. These and other risks concerning KemPharm's business are described in additional detail in KemPharm's Quarterly Report on Form 10-Q for the quarter ended June 30, 2016, and KemPharm's other Periodic and Current Reports filed with the Securities and Exchange Commission. KemPharm is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.
Item 9.01
Financial Statements and Exhibits.
(d)
Exhibits
Exhibit
No.
Description
99.1
Press Release titled
"
KemPharm Announces Licensing Agreement with Acura Pharmaceuticals for Aversion® Abuse-Deterrent Technology"
dated October 18, 2016.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
K
EM
P
HARM
, I
NC
.
Date: October 18
, 2016
By:
/s/ R. LaDuane Clifton
R. LaDuane Clifton
Chief Financial
Officer
Exhibit
Index
Exhibit
No.
Description
99.1
Press Release titled "KemPharm Announces Licensing Agreement with Acura Pharmaceuticals for Aversion® Abuse-Deterrent Technology
" dated October 18, 2016.