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style="font-family:'Times New Roman','Times','serif';font-size:10pt;padding-bottom:1pt;padding-top:1pt;text-indent:0pt;border-bottom:3.0pt solid #000000;border-top:1px solid #000000;margin:0pt;"><span style="font-size:1pt;margin-bottom:12pt;visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:0pt;margin:0pt;"><span style="font-size:6pt;margin-bottom:12pt;visibility:hidden;">&#8203;</span></p><p style="display:none;font-family:'Times New Roman','Times','serif';line-height:0pt;margin:0pt;"><span style="font-size:0pt;visibility:hidden;">&#8203;</span></p></div></div>
<div style="background-color:#000000;clear:both;height:2pt;page-break-after:always;width:79.3%;border:0;margin:30pt 10.35% 30pt 10.35%;"></div><div style="max-width:100%;padding-left:10.35%;padding-right:10.35%;position:relative;"><div style="clear:both;max-width:100%;position:relative;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;padding-left:45pt;text-indent:-45pt;margin:0pt 0pt 6pt 0pt;"><b style="font-weight:bold;">Item 8.01 Other Events.</b></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:6pt 0pt 0pt 0pt;">On October 1, 2021, Omeros Corporation (the &#8220;Company&#8221;) announced that the U.S. Food and Drug Administration (the &#8220;FDA&#8221;) notified the Company that, as part of FDA&#8217;s ongoing review of the Company&#8217;s Biologics License Application (&#8220;BLA&#8221;) for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy, FDA has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time. FDA stated that the notification does not reflect a final decision on the information under review.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:6pt 0pt 0pt 0pt;">FDA did not provide specific details of the deficiencies in its notification; however, in a meeting held September 30, 2021, FDA expressed its intention to work with the Company to resolve any issues as expeditiously as possible, but the Company does not currently expect any such resolution to occur by the October 17, 2021 target action date under the Prescription Drug User Fee Act. The Company is evaluating potential next steps as it awaits additional information from FDA and plans to obtain FDA approval for narsoplimab in HSCT-TMA, a frequently lethal complication of HSCT for which there is no FDA-approved treatment, as quickly as possible.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:6pt 0pt 0pt 0pt;">The Company&#8217;s press release, dated October 1, 2021, announcing the notification from FDA is filed with this Form 8-K as Exhibit 99.1 and is incorporated by reference herein. </p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:6pt 0pt 0pt 0pt;">This Current Report on Form 8-K contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which are subject to the &#8220;safe harbor&#8221; created by those sections for such statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as &#8220;anticipate,&#8221; &#8220;believe,&#8221; &#8220;could,&#8221; &#8220;estimate,&#8221; &#8220;expect,&#8221; &#8220;goal,&#8221; &#8220;intend,&#8221; &#8220;likely,&#8221; &#8220;look forward to,&#8221; &#8220;may,&#8221; &#8220;objective,&#8221; &#8220;plan,&#8221; &#8220;potential,&#8221; &#8220;predict,&#8221; &#8220;project,&#8221; &#8220;should,&#8221; &#8220;slate,&#8221; &#8220;target,&#8221; &#8220;will,&#8221; &#8220;would&#8221; and similar expressions and variations thereof. Forward-looking statements, including expectations with regard to interactions and communications with FDA, FDA&#8217;s review of the Company&#8217;s BLA for narsoplimab in HSCT-TMA and the Company&#8217;s pursuit of regulatory approval for narsoplimab in HSCT-TMA, are based on management&#8217;s beliefs and assumptions and on information available to management only as of the date of this press release. The Company&#8217;s actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, risks associated with product commercialization and commercial operations, regulatory processes and oversight, and the risks, uncertainties and other factors described under the heading &#8220;Risk Factors&#8221; in the Company&#8217;s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 1, 2021. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and the Company assumes no obligation to update these forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:6pt 0pt 0pt 0pt;"><span style="visibility:hidden;">&#8203;</span></p><table style="border-collapse:collapse;font-size:16pt;height:max-content;margin-left:auto;margin-right:auto;padding-left:2.35pt;padding-right:2.35pt;width:100%;"><tr style="height:1pt;"><th style="font-weight:normal;text-align:left;vertical-align:top;width:15.43%;margin:0pt;padding:0pt 2.34pt 0pt 2.34pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="position:absolute;top:0pt;width:100%;"></div></div></th><th style="font-weight:normal;text-align:left;vertical-align:top;width:3.12%;margin:0pt;padding:0pt 2.34pt 0pt 2.34pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="position:absolute;top:0pt;width:100%;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;line-height:1.37;margin:6pt 0pt 0pt 0pt;"><span style="visibility:hidden;">&#8203;</span></p></div></div></th><th style="font-weight:normal;text-align:left;vertical-align:bottom;width:81.44%;margin:0pt;padding:0pt 2.34pt 0pt 2.34pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;line-height:1.37;margin:6pt 0pt 0pt 0pt;"><span style="visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="font-size:1pt;visibility:hidden;">&#8203;</span></p></div></div></th></tr><tr><th style="font-weight:normal;text-align:left;vertical-align:top;width:15.43%;margin:0pt;padding:0pt 2.34pt 0pt 2.34pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;line-height:1.37;margin:0pt;"><b style="font-weight:bold;">Item&#160;9.01</b></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;line-height:1.37;margin:0pt;">(d) Exhibits.</p></th><th style="font-weight:normal;text-align:left;vertical-align:top;width:3.12%;margin:0pt;padding:0pt 2.34pt 0pt 2.34pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;line-height:1.37;margin:0pt;"><span style="font-weight:bold;visibility:hidden;">&#8203;</span></p></th><th style="font-weight:normal;text-align:left;vertical-align:bottom;width:81.44%;margin:0pt;padding:0pt 2.34pt 0pt 2.34pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;line-height:1.37;margin:0pt;"><b style="font-weight:bold;">Financial Statements and Exhibits.</b></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;line-height:1.37;margin:0pt;"><span style="font-weight:bold;visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;line-height:1.37;margin:6pt 0pt 0pt 0pt;"><span style="visibility:hidden;">&#8203;</span></p></th></tr></table><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p><table style="border-collapse:collapse;font-size:16pt;height:max-content;padding-left:0pt;padding-right:0pt;width:100%;"><tr style="height:1pt;"><td style="vertical-align:top;width:18.53%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="position:absolute;top:0pt;width:100%;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="font-size:1pt;visibility:hidden;">&#8203;</span></p></div></div></td><td style="vertical-align:top;width:81.46%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="position:absolute;top:0pt;width:100%;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="font-size:1pt;visibility:hidden;">&#8203;</span></p></div></div></td></tr><tr><td style="vertical-align:top;width:18.53%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><b style="font-weight:bold;text-decoration:underline;text-decoration-color:#000000;">Exhibit&#160;Number</b></p></td><td style="vertical-align:top;width:81.46%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><b style="font-weight:bold;text-decoration:underline;text-decoration-color:#000000;">Description</b></p></td></tr><tr><td style="vertical-align:top;width:18.53%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">99.1</p></td><td style="vertical-align:top;width:81.46%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><a style="-sec-extract:exhibit;" href="omer-20211001xex99d1.htm"><span style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-style:normal;font-weight:normal;text-align:left;">Press Release dated October 1, 2021.</span></a></p></td></tr><tr><td style="vertical-align:top;width:18.53%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">104</p></td><td style="vertical-align:top;width:81.46%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">Cover Page Interactive Data File (embedded within the Inline XBRL document)</p></td></tr></table><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p></div><div style="clear:both;margin-bottom:30pt;width:100%;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p></div></div>
<div style="background-color:#000000;clear:both;height:2pt;page-break-after:always;width:79.3%;border:0;margin:30pt 10.35% 30pt 10.35%;"></div><div style="max-width:100%;padding-left:10.35%;padding-right:10.35%;position:relative;"><div style="clear:both;max-width:100%;position:relative;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-weight:bold;text-align:center;margin:0pt 0pt 12pt 0pt;">SIGNATURES</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:0pt 0pt 12pt 0pt;">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 hereunto duly authorized.</p><table style="border-collapse:collapse;font-size:16pt;height:max-content;margin-left:auto;margin-right:auto;padding-left:0pt;padding-right:0pt;width:100%;"><tr style="height:1pt;"><td style="vertical-align:bottom;width:50.08%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="font-size:1pt;visibility:hidden;">&#8203;</span></p></div></div></td><td style="vertical-align:bottom;width:3.69%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="font-size:1pt;visibility:hidden;">&#8203;</span></p></div></div></td><td style="vertical-align:bottom;width:46.21%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="font-size:1pt;visibility:hidden;">&#8203;</span></p></div></div></td></tr><tr><td style="vertical-align:bottom;width:50.08%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="font-weight:bold;visibility:hidden;">&#8203;</span></p></td><td colspan="2" style="vertical-align:bottom;width:49.91%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><b style="font-weight:bold;">OMEROS CORPORATION</b></p></td></tr><tr><td style="vertical-align:bottom;width:50.08%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p></td><td style="vertical-align:bottom;width:3.69%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p></td><td style="vertical-align:bottom;width:46.21%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p></td></tr><tr><td style="vertical-align:middle;width:50.08%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">Date: October 1, 2021</p></td><td style="vertical-align:bottom;width:3.69%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">By:</p></td><td style="vertical-align:bottom;width:46.21%;border-bottom:1px solid #000000;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">/s/ Gregory A. Demopulos</p></td></tr><tr><td style="vertical-align:bottom;width:50.08%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p></td><td style="vertical-align:bottom;width:3.69%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p></td><td style="vertical-align:bottom;width:46.21%;border-top:1px solid #000000;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">Gregory A. Demopulos, M.D.</p></td></tr><tr><td style="vertical-align:bottom;width:50.08%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p></td><td style="vertical-align:bottom;width:3.69%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p></td><td style="vertical-align:bottom;width:46.21%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">President, Chief Executive Officer and</p></td></tr><tr><td style="vertical-align:bottom;width:50.08%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p></td><td style="vertical-align:bottom;width:3.69%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p></td><td style="vertical-align:bottom;width:46.21%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">Chairman of the Board of Directors</p></td></tr></table><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p></div><div style="clear:both;margin-bottom:30pt;width:100%;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p></div></div>
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​
​
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 event reported):
October 1, 2021
OMEROS CORPORATION
(Exact name of Registrant as Specified in Its Charter)
​
Washington
001-34475
91-1663741
(State or Other Jurisdiction
of Incorporation)
(Commission File Number)
(IRS Employer
Identification No.)
201 Elliott Avenue West
Seattle
,
WA
98119
(Address of Principal Executive Offices)
(Zip Code)
​
Registrant's Telephone Number, Including Area Code: (
206
)
676-5000
​
(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 Instruction 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))
​
Securities Registered Pursuant to Section 12(b) of the Act:
​
Title of each class
Trading Symbol(s)
Name of each exchange on which registered
Common stock, $0.01 par value per share
OMER
The Nasdaq Stock Market LLC
​
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 under the Securities Act of 1933 (17 CFR 230.405) or Rule 12b-2 under the Securities Exchange Act of 1934 (17 CFR 240.12b-2).
​
Emerging growth company
☐
​
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
☐
​
​
​
​
Item 8.01 Other Events.
On October 1, 2021, Omeros Corporation (the "Company") announced that the U.S. Food and Drug Administration (the "FDA") notified the Company that, as part of FDA's ongoing review of the Company's Biologics License Application ("BLA") for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy, FDA has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time. FDA stated that the notification does not reflect a final decision on the information under review.
FDA did not provide specific details of the deficiencies in its notification; however, in a meeting held September 30, 2021, FDA expressed its intention to work with the Company to resolve any issues as expeditiously as possible, but the Company does not currently expect any such resolution to occur by the October 17, 2021 target action date under the Prescription Drug User Fee Act. The Company is evaluating potential next steps as it awaits additional information from FDA and plans to obtain FDA approval for narsoplimab in HSCT-TMA, a frequently lethal complication of HSCT for which there is no FDA-approved treatment, as quickly as possible.
The Company's press release, dated October 1, 2021, announcing the notification from FDA is filed with this Form 8-K as Exhibit 99.1 and is incorporated by reference herein.
This Current Report on Form 8-K contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which are subject to the "safe harbor" created by those sections for such statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as "anticipate," "believe," "could," "estimate," "expect," "goal," "intend," "likely," "look forward to," "may," "objective," "plan," "potential," "predict," "project," "should," "slate," "target," "will," "would" and similar expressions and variations thereof. Forward-looking statements, including expectations with regard to interactions and communications with FDA, FDA's review of the Company's BLA for narsoplimab in HSCT-TMA and the Company's pursuit of regulatory approval for narsoplimab in HSCT-TMA, are based on management's beliefs and assumptions and on information available to management only as of the date of this press release. The Company's actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, risks associated with product commercialization and commercial operations, regulatory processes and oversight, and the risks, uncertainties and other factors described under the heading "Risk Factors" in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 1, 2021. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and the Company assumes no obligation to update these forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
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Item 9.01
(d) Exhibits.
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Financial Statements and Exhibits.
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Exhibit Number
Description
99.1
Press Release dated October 1, 2021.
104
Cover Page Interactive Data File (embedded within the Inline XBRL document)
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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 hereunto duly authorized.
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OMEROS CORPORATION
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Date: October 1, 2021
By:
/s/ Gregory A. Demopulos
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Gregory A. Demopulos, M.D.
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President, Chief Executive Officer and
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Chairman of the Board of Directors
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