<SEC-DOCUMENT>0001178913-21-002342.txt : 20210722
<SEC-HEADER>0001178913-21-002342.hdr.sgml : 20210722
<ACCEPTANCE-DATETIME>20210722092541
ACCESSION NUMBER:		0001178913-21-002342
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20210722
FILED AS OF DATE:		20210722
DATE AS OF CHANGE:		20210722

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			RedHill Biopharma Ltd.
		CENTRAL INDEX KEY:			0001553846
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				000000000
		STATE OF INCORPORATION:			L3

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-35773
		FILM NUMBER:		211106182

	BUSINESS ADDRESS:	
		STREET 1:		21 HA'ARBA'A STREET
		CITY:			TEL AVIV
		STATE:			L3
		ZIP:			64739
		BUSINESS PHONE:		972-3-541-3131

	MAIL ADDRESS:	
		STREET 1:		21 HA'ARBA'A STREET
		CITY:			TEL AVIV
		STATE:			L3
		ZIP:			64739
</SEC-HEADER>
<DOCUMENT>
<TYPE>6-K
<SEQUENCE>1
<FILENAME>zk2126318.htm
<DESCRIPTION>6-K
<TEXT>
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    <div style="text-align: center; line-height: 1.25; font-weight: bold;">Washington, D.C.&#160;20549</div>
    <div style="text-align: center; line-height: 1.25;">&#160;</div>
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    <div style="text-align: center; line-height: 1.25;">&#160;&#160;</div>
    <div style="text-align: center; line-height: 1.25; font-weight: bold;">Report of Foreign Private Issuer</div>
    <div style="text-align: center; line-height: 1.25; font-weight: bold;">Pursuant to Rule 13a-16 or 15d-16</div>
    <div style="text-align: center; line-height: 1.25; font-weight: bold;">of&#160;the Securities Exchange Act of 1934</div>
    <div style="text-align: center; line-height: 1.25; font-weight: bold;">&#160;</div>
    <div style="text-align: center; line-height: 1.25;">For the month of July 2021<br>
      Commission File No.:001-35773</div>
    <div style="text-align: center; line-height: 1.25;">&#160;</div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-size: 16pt; font-weight: bold; background-color: rgb(255, 255, 255); color: rgb(0, 0, 0); font-style: normal; font-variant: normal; text-transform: none;">REDHILL BIOPHARMA LTD.</div>
    <div style="text-align: center; line-height: 1.25;">(Translation of registrant&#8217;s name into English)</div>
    <div style="text-align: center; line-height: 1.25;">&#160;</div>
    <div style="text-align: center; line-height: 1.25; font-weight: bold;">21 Ha'arba'a Street, Tel Aviv, 6473921, Israel</div>
    <div style="text-align: center; line-height: 1.25;">(Address of principal executive offices)</div>
    <div style="line-height: 1.25;">&#160;</div>
    <div style="text-align: justify; text-indent: 28.35pt; line-height: 1.25;">Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.&#160;&#160;</div>
    <div style="text-align: center; text-indent: 14.2pt; line-height: 1.25;">Form 20-F &#9746;&#160;<font style="font-family: 'Segoe UI Symbol', sans-serif;"> &#160;&#160;</font> Form 40-F&#160;<font style="font-family: 'Segoe UI Symbol', sans-serif;">&#9744;</font></div>
    <div style="text-indent: 14.2pt; line-height: 1.25;">&#160;</div>
    <div style="text-align: justify; text-indent: 28.35pt; line-height: 1.25;">Indicate by check mark if the Registrant is&#160;submitting&#160;the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ____&#160;</div>
    <div style="text-indent: 28.35pt; line-height: 1.25;">&#160;</div>
    <div style="text-align: justify; text-indent: 28.35pt; line-height: 1.25;">Indicate by check mark if the Registrant is&#160;submitting&#160;the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ____</div>
    <div style="line-height: 1.25;">&#160;</div>
    <div style="text-align: justify; line-height: 1.25;">Attached hereto and incorporated by reference herein is the following:</div>
    <div style="line-height: 1.25">&#160;</div>
    <div style="line-height: 1.25;"><a href="exhibit_1.htm">Exhibit 1<font style="font-family: Symbol, serif;">:</font>&#160;Registrant's press release entitled:
        &#8220;RedHill Biopharma Announces Settlement of Movantik&#174; Patent Litigation with Apotex&#8221;</a></div>
    <div style="line-height: 1.25">&#160;</div>
    <div style="text-align: justify; line-height: 1.25;">Exhibit 99.1 (solely with respect to the first two paragraphs) to this Report on Form 6-K are hereby incorporated by reference into the Company's Registration Statements on Form S-8 filed with the
      Securities and Exchange Commission on May 2, 2013 (Registration No. 333-188286), on October 29, 2015 (Registration No. 333-207654), on July 25, 2017 (Registration No. 333-219441),on May 23, 2018 (Registration No. 333-225122), on July 24, 2019 (File
      No. 333-232776) on March 25, 2021 (File No. 333-254692) and on May 3, 2021 (File No. 333-255710), and its Registration Statements on Form F-3 filed with the Securities and Exchange Commission on February 25, 2016 (Registration No. 333-209702), on
      July 23, 2018 (File No. 333-226278), on July 24, 2019 (File No. 333-232777) and on March 30, 2021 (File No. 333-254848).</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
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    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
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    <div style="text-align: center; line-height: 1.25; font-weight: bold;">SIGNATURES</div>
    <div style="text-align: justify; text-indent: 28.35pt; line-height: 1.25;">&#160;</div>
    <div style="text-align: justify; line-height: 1.25;">Pursuant to the requirements of&#160;the&#160;Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.&#160;</div>
    <div style="text-align: justify; margin-left: 220.65pt; line-height: 1.25;">&#160;</div>
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            <div style="line-height: 1.25;">&#160;</div>
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            <div style="line-height: 1.25;">REDHILL BIOPHARMA LTD.</div>
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            <div style="line-height: 1.25;">&#160;</div>
          </td>
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            <div style="line-height: 1.25;">&#160;</div>
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            <div style="line-height: 1.25;">(the "Registrant")</div>
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            <div style="line-height: 1.25;">&#160;</div>
          </td>
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            <div style="line-height: 1.25;">&#160;</div>
          </td>
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            <div style="line-height: 1.25;">&#160;</div>
          </td>
          <td style="width: 30.44%; vertical-align: middle;">
            <div style="line-height: 1.25;">&#160;</div>
          </td>
          <td style="width: 16.42%; vertical-align: bottom;">
            <div style="line-height: 1.25;">&#160;</div>
          </td>
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          <td style="width: 49.66%; vertical-align: middle;">
            <div style="line-height: 1.25;">Date: July 22, 2021</div>
          </td>
          <td style="width: 3.48%; vertical-align: middle;">
            <div style="line-height: 1.25;">By:</div>
          </td>
          <td style="width: 30.44%; vertical-align: middle; border-bottom: #000000 2px solid;">
            <div style="line-height: 1.25;">&#160;/s/ Dror Ben-Asher&#160;</div>
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          <td style="width: 16.42%; vertical-align: bottom;">
            <div style="line-height: 1.25;">&#160;</div>
          </td>
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            <div style="line-height: 1.25;">&#160;</div>
          </td>
          <td colspan="2" style="width: 33.91%; vertical-align: middle;">
            <div style="line-height: 1.25;">Dror Ben-Asher&#160;</div>
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            <div style="line-height: 1.25;">&#160;</div>
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            <div style="line-height: 1.25;">&#160;</div>
          </td>
          <td colspan="2" style="width: 33.91%; vertical-align: middle;">
            <div style="line-height: 1.25;">Chief Executive Officer</div>
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          <td style="width: 16.42%; vertical-align: bottom;">
            <div style="line-height: 1.25;">&#160;</div>
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    <div style="text-align: justify; line-height: 1.25;">&#160;</div>
    <div style="text-align: justify; line-height: 1.25;">
      <div style="text-align: center;">&#160;2</div>
      <hr align="center" style="border: none; border-bottom: 4px solid black; border-top: 1px solid black; height: 10px; color: #ffffff; background-color: #ffffff; text-align: center; margin-left: auto; margin-right: auto;"></div>
    <div style="line-height: 1.25;">&#160;</div>
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    </div>
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    </div>
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<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>exhibit_1.htm
<DESCRIPTION>EXHIBIT 1
<TEXT>
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    <div style="line-height: 1.25; text-align: right;"><u><font style="font-weight: bold;">Exhibit 1</font></u><br style="line-height: 1.25;">
    </div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="line-height: 1.25;"><img width="150" height="89" src="image0.jpg"></div>
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          <tr>
            <td style="width: 50%; text-align: center; border-color: rgb(0, 0, 0); border-style: solid; border-width: 2px;" rowspan="1">
              <div style="background-color: rgb(255, 255, 255); font-weight: normal; color: rgb(0, 0, 0); font-family: 'Times New Roman',Times,serif; font-size: 14pt; font-style: normal; font-variant: normal; text-transform: none;">&#160;Press Release</div>
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    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="line-height: 1.25;">
      <div style="text-align: center; text-indent: 42.55pt; line-height: 1.25;">
        <div style="line-height: 1.25; font-weight: bold; font-family: 'Times New Roman',Times,serif; font-size: 12pt; background-color: rgb(255, 255, 255); color: rgb(0, 0, 0); font-style: normal; font-variant: normal; text-transform: none;"><u>RedHill
            Biopharma Announces Settlement of Movantik&#174; </u></div>
        <u><font style="font-weight: bold; background-color: rgb(255, 255, 255); color: rgb(0, 0, 0); font-family: 'Times New Roman',Times,serif; font-size: 12pt; font-style: normal; font-variant: normal; text-transform: none;"> </font></u>
        <div style="line-height: 1.25; font-weight: bold; font-family: 'Times New Roman',Times,serif; font-size: 12pt; background-color: rgb(255, 255, 255); color: rgb(0, 0, 0); font-style: normal; font-variant: normal; text-transform: none;"><u>Patent
            Litigation with Apotex</u></div>
      </div>
    </div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: justify; line-height: 1.25;"><font style="font-weight: bold;">TEL AVIV, Israel and RALEIGH, NC, July 22, 2021, </font><u>RedHill Biopharma Ltd.</u> (Nasdaq: <u>RDHL</u>) (&#8220;RedHill&#8221; or the &#8220;Company&#8221;), a specialty
      biopharmaceutical company, today announced that RedHill Biopharma Inc., AstraZeneca AB and AstraZeneca Pharmaceuticals LP (&#8220;AstraZeneca&#8221;) and Nektar Therapeutics have entered into a settlement and license agreement with Apotex, Inc. and Apotex Corp.
      (&#8220;Apotex&#8221;) resolving their patent litigation in the U.S. in response to Apotex&#8217;s Abbreviated New Drug Application (&#8220;ANDA&#8221;) seeking approval by the US. Food and Drug Administration (&#8220;FDA&#8221;) to market a generic version of Movantik&#174; (naloxegol).</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="line-height: 1.25;">
      <div style="text-align: justify; line-height: 1.25;">RedHill acquired from AstraZeneca in April 2020 the global rights to Movantik, excluding Europe and Canada.</div>
      <div style="line-height: 1.25">&#160;</div>
      <div style="text-align: justify; line-height: 1.25;">Under the terms of the settlement agreement, Apotex may not sell a generic version of Movantik in the U.S. until October 1, 2030 (subject to U.S. FDA approval) or earlier under certain
        circumstances.</div>
      <div style="line-height: 1.25">&#160;</div>
      <div style="text-align: justify; line-height: 1.25;">The parties to the settlement agreement have also agreed to file a stipulation and order of dismissal with the U.S. District Court for the District of Delaware which will conclude this litigation
        with respect to Apotex. As required by law, the parties will submit the settlement agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review. The settlement with Apotex does not end RedHill&#8217;s ongoing litigation
        against the other one ANDA filer.</div>
      <div style="line-height: 1.25">&#160;</div>
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    <div style="text-align: justify; line-height: 1.25;"><font style="font-weight: bold;">About RedHill Biopharma</font>&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;<font style="font-weight: bold;">&#160;&#160;&#160;</font></div>
    <div style="text-align: justify; line-height: 1.25;">RedHill Biopharma Ltd. (Nasdaq: <u>RDHL</u>) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, <font style="font-weight: bold;">Movantik</font><sup style="font-weight: bold; vertical-align: text-top; line-height: 1; font-size: smaller;">&#174; </sup>for opioid-induced constipation in adults<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">1</sup>, <font style="font-weight: bold;">Talicia</font><sup style="font-weight: bold; vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup><font style="font-weight: bold;">&#160;</font>for the treatment of <font style="font-style: italic;">Helicobacter pylori (H. pylori)</font> infection in adults<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">2</sup>, and <font style="font-weight: bold;">Aemcolo</font><sup style="font-weight: bold; vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup>
      for the treatment of travelers&#8217; diarrhea in adults<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">3</sup>. RedHill&#8217;s key clinical late-stage development programs include: (i) <font style="font-weight: bold;">RHB-204</font>,<font style="font-weight: bold;">&#160;</font>with an ongoing Phase 3
      study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) <font style="font-weight: bold;">opaganib</font>, a first<font style="font-weight: bold;">-</font>in<font style="font-weight: bold;">-</font>class SK2 selective inhibitor targeting
      multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) <font style="font-weight: bold;">RHB-107 </font>(<font style="font-weight: bold;">upamostat</font>), a serine
      protease inhibitor in a U.S. Phase 2/3 study for symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) <font style="font-weight: bold;">RHB-104</font>, with positive results from a first Phase 3
      study for Crohn's disease; (v) <font style="font-weight: bold;">RHB-102</font> (<font style="font-weight: bold;">Bekinda</font><sup style="font-weight: bold; vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup>), with positive results from a Phase 3 study for acute gastroenteritis and
      gastritis and positive results from a Phase 2 study for IBS-D; and (vi) <font style="font-weight: bold;">RHB</font>-<font style="font-weight: bold;">106</font>, an encapsulated bowel preparation. More information about the Company is available at <u>www.redhillbio.com</u>
      / <u>https://twitter.com/RedHillBio</u>.</div>
    <div style="text-align: justify; line-height: 1.25;"> <br>
    </div>
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    </div>
    <div style="text-align: justify; line-height: 1.25; font-style: italic;">This press release contains &#8220;forward-looking statements&#8221; within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words
      &#8220;intends,&#8221; &#8220;may,&#8221; &#8220;will,&#8221; &#8220;plans,&#8221; &#8220;expects,&#8221; &#8220;anticipates,&#8221; &#8220;projects,&#8221; &#8220;predicts,&#8221; &#8220;estimates,&#8221; &#8220;aims,&#8221; &#8220;believes,&#8221; &#8220;hopes,&#8221; &#8220;potential&#8221; or similar words. Forward-looking statements are based on certain assumptions and are subject to various known
      and unknown risks and uncertainties, many of which are beyond the Company&#8217;s control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such
      risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company&#8217;s research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the
      commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company&#8217;s ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical
      trials (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company&#8217;s receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and
      feedback; (iv) the risk that the Company will not succeed to complete the patient recruitment; the risk that the Company will not receive the relevant data required for benefiting from the Fast Track designation; the risk that the U.S. Phase 3
      clinical study evaluating RHB-204 will not be successful or, if successful, will not suffice for regulatory marketing approval without the need for additional clinical and/or other studies; (v) the manufacturing, clinical development,
      commercialization, and market acceptance of the Company&#8217;s therapeutic candidates and Talicia&#174;; (vi) the Company&#8217;s ability to successfully commercialize and promote Movantik&#174;, Talicia&#174; and Aemcolo&#174;; (vii) the Company&#8217;s ability to establish and
      maintain corporate collaborations; (viii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (ix) the interpretation
      of the properties and characteristics of the Company&#8217;s therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (x) the implementation of the Company&#8217;s business model,
      strategic plans for its business and therapeutic candidates; (xi) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to
      operate its business without infringing the intellectual property rights of others; (xii) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xiii) estimates of the Company&#8217;s expenses,
      future revenues, capital requirements and needs for additional financing; (xiv) the effect of patients suffering adverse events using investigative drugs under the Company's Expanded Access Program; and (xv) competition from other companies and
      technologies within the Company&#8217;s industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange
      Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 18, 2021. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no
      obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.</div>
    <table cellspacing="0" cellpadding="0" border="0" id="zc84b58ff7989418eb76f09a5aca3bc91" style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; width: 100%; text-align: left; color: #000000;">

        <tr>
          <td style="width: 50%; vertical-align: top;">
            <div style="line-height: 1.25;"><font style="line-height: 1.25;">&#160;</font></div>
            <div style="line-height: 1.25; font-weight: bold;">Company contact:</div>
            <div style="line-height: 1.25;">Adi Frish</div>
            <div style="line-height: 1.25;">Chief Corporate &amp; Business Development Officer</div>
            <div style="line-height: 1.25;">RedHill Biopharma</div>
            <div style="line-height: 1.25;">+972-54-6543-112</div>
            <div style="line-height: 1.25;"><u>adi@redhillbio.com</u></div>
          </td>
          <td style="width: 50%; vertical-align: top;">
            <div style="line-height: 1.25;"><font style="line-height: 1.25;">&#160;</font></div>
            <div style="line-height: 1.25; font-weight: bold;">Media contact (U.S.):</div>
            <div style="text-align: justify; line-height: 1.25;">Bryan Gibbs</div>
            <div style="text-align: justify; line-height: 1.25;">Vice President</div>
            <div style="text-align: justify; line-height: 1.25;">Finn Partners</div>
            <div style="text-align: justify; line-height: 1.25;">+1 212 529 2236</div>
            <div style="line-height: 1.25;"><u>bryan.gibbs@finnpartners.com</u></div>
          </td>
        </tr>

    </table>
    <br>
    <hr noshade="noshade" align="left" style="background-color: #000000; border: 0px; height: 1px; width: 2in; margin-left: 0pt; margin-right: auto; color: #000000;">
    <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">1</sup> Full prescribing information for Movantik&#174; (naloxegol) is available at: www.Movantik.com.</div>
    <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">2</sup> Full prescribing information for Talicia&#174; (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.</div>
    <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;"><sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">3</sup> Full prescribing information for Aemcolo&#174; (rifamycin) is available at: www.Aemcolo.com.</div>
    <div style="text-align: justify; line-height: 1.25;"> <br>
    </div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif;">2<br>
    </div>
    <div style="text-align: justify; line-height: 1.25;">
      <hr align="center" style="border: none; border-bottom: 4px solid black; border-top: 1px solid black; height: 10px; color: #ffffff; background-color: #ffffff; text-align: center; margin-left: auto; margin-right: auto;"> </div>
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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
