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			kala_Current_Folio_8K
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			<font style="display:inline;font-family:Times New Roman,Times,serif;font-weight:bold;font-size:18pt;">SECURITIES AND EXCHANGE COMMISSION</font>
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			<font style="display:inline;font-family:Times New Roman,Times,serif;font-weight:bold;font-size:18pt;">FORM 8-K</font>
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			<font style="display:inline;font-family:Times New Roman,Times,serif;font-weight:bold;font-size:12pt;">CURRENT REPORT</font>
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			<font style="display:inline;font-family:Times New Roman,Times,serif;font-weight:bold;font-size:12pt;">Pursuant to Section 13 or 15(d)</font>
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			<font style="display:inline;font-family:Times New Roman,Times,serif;font-weight:bold;font-size:12pt;">of the Securities Exchange Act of 1934</font>
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			<font style="display:inline;font-family:Times New Roman,Times,serif;">Date of Report (Date of earliest event reported): </font><font style="display:inline;font-family:Times New Roman,Times,serif;font-weight:bold;">May 26, 2020</font>
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			<font style="display:inline;font-family:Times New Roman,Times,serif;font-weight:bold;font-size:18pt;">Kala Pharmaceuticals, Inc.</font>
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			<font style="display:inline;font-family:Times New Roman,Times,serif;">(Exact Name of Company as Specified in its Charter)</font>
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						<font style="display:inline;font-family:Times New Roman,Times,serif;font-weight:bold;">Delaware</font></p>
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						<font style="display:inline;font-family:Times New Roman,Times,serif;font-weight:bold;">001-38150</font></p>
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						<font style="display:inline;font-family:Times New Roman,Times,serif;font-weight:bold;">27-0604595</font></p>
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						<font style="display:inline;font-family:Times New Roman,Times,serif;">(State or Other Jurisdiction of Incorporation)</font></p>
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						<font style="display:inline;font-family:Times New Roman,Times,serif;">(Commission File Number)</font></p>
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						<font style="display:inline;font-family:Times New Roman,Times,serif;">(IRS Employer Identification No.)</font></p>
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			<font style="display:inline;font-family:Times New Roman,Times,serif;font-weight:bold;">490 Arsenal Way, Suite 120</font>
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			<font style="display:inline;font-family:Times New Roman,Times,serif;font-weight:bold;">Watertown, MA 02472</font>
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			<font style="display:inline;font-family:Times New Roman,Times,serif;">(Address of Principal Executive Offices) (Zip Code)</font>
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			<font style="display:inline;font-family:Times New Roman,Times,serif;">Company&#x2019;s telephone number, including area code: </font><font style="display:inline;font-family:Times New Roman,Times,serif;font-weight:bold;">(781) 996-5252</font>
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			<font style="display:inline;font-size:7pt;">&nbsp;</font>
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		<p style="margin:0pt;font-family:Times New Roman,Times,serif;font-size: 10pt;">
			<font style="display:inline;font-family:Times New Roman,Times,serif;">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):</font>
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						<font style="display:inline;font-family:Segoe UI Symbol;">&#x2610;</font></p>
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					<p style="margin:0pt;font-family:Times New Roman,Times,serif;font-size: 10pt;">
						<font style="display:inline;font-family:Times New Roman,Times,serif;">Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)</font></p>
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					<p style="margin:0pt;font-family:Times New Roman,Times,serif;font-size: 8pt;">
						<font style="display:inline;font-family:Times New Roman,Times,serif;font-size:8pt;">&nbsp;</font></p>
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						<font style="display:inline;font-family:Times New Roman,Times,serif;font-size:8pt;">&nbsp;</font></p>
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						<font style="display:inline;font-family:Segoe UI Symbol;">&#x2610;</font></p>
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						<font style="display:inline;font-family:Times New Roman,Times,serif;">Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)</font></p>
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					<p style="margin:0pt;font-family:Times New Roman,Times,serif;font-size: 8pt;">
						<font style="display:inline;font-family:Times New Roman,Times,serif;font-size:8pt;">&nbsp;</font></p>
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						<font style="display:inline;font-family:Times New Roman,Times,serif;font-size:8pt;">&nbsp;</font></p>
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					<p style="margin:0pt;font-family:Times New Roman,Times,serif;font-size: 10pt;">
						<font style="display:inline;font-family:Segoe UI Symbol;">&#x2610;</font></p>
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					<p style="margin:0pt;font-family:Times New Roman,Times,serif;font-size: 10pt;">
						<font style="display:inline;font-family:Times New Roman,Times,serif;">Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))</font></p>
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					<p style="margin:0pt;font-family:Times New Roman,Times,serif;font-size: 8pt;">
						<font style="display:inline;font-family:Times New Roman,Times,serif;font-size:8pt;">&nbsp;</font></p>
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						<font style="display:inline;font-family:Times New Roman,Times,serif;font-size:8pt;">&nbsp;</font></p>
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					<p style="margin:0pt;font-family:Times New Roman,Times,serif;font-size: 10pt;">
						<font style="display:inline;font-family:Segoe UI Symbol;">&#x2610;</font></p>
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					<p style="margin:0pt;font-family:Times New Roman,Times,serif;font-size: 10pt;">
						<font style="display:inline;font-family:Times New Roman,Times,serif;">Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))</font></p>
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			<font style="display:inline;font-family:Times New Roman,Times,serif;">Securities registered pursuant to Section 12(b) of the Act:</font>
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			<font style="display:inline;font-size:7pt;">&nbsp;</font>
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					<p style="margin:0pt;text-align:center;font-family:Times New Roman,Times,serif;font-size: 10pt;">
						<font style="display:inline;font-family:Times New Roman,Times,serif;font-weight:bold;">Title of each class</font></p>
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						<font style="display:inline;font-family:Times New Roman,Times,serif;font-weight:bold;">Trading symbol(s)</font></p>
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						<font style="display:inline;font-family:Times New Roman,Times,serif;font-weight:bold;">Name of each exchange on which registered</font></p>
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					<p style="margin:0pt;text-align:center;font-family:Times New Roman,Times,serif;font-size: 10pt;">
						<font style="display:inline;font-family:Times New Roman,Times,serif;">Common Stock, $0.001 par value per share</font></p>
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					<p style="margin:0pt;text-align:center;font-family:Times New Roman,Times,serif;font-size: 10pt;">
						<font style="display:inline;font-family:Times New Roman,Times,serif;">KALA</font></p>
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					<p style="margin:0pt;text-align:center;font-family:Times New Roman,Times,serif;font-size: 10pt;">
						<font style="display:inline;font-family:Times New Roman,Times,serif;">The Nasdaq Global Select Market</font></p>
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			<font style="display:inline;font-size:7pt;">&nbsp;</font>
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		<p style="margin:0pt;text-indent:36pt;font-family:Times New Roman,Times,serif;font-size: 10pt;">
			<font style="display:inline;font-family:Times New Roman,Times,serif;">Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (&#xA7;230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (&#xA7;240.12b-2 of this chapter).</font>
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			<font style="display:inline;font-size:7pt;">&nbsp;</font>
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			<font style="display:inline;font-family:Times New Roman,Times,serif;">Emerging growth company </font><font style="display:inline;font-family:Segoe UI Symbol;">&#x2612;</font>
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			<font style="display:inline;font-size:7pt;">&nbsp;</font>
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		<p style="margin:0pt;text-indent:36pt;font-family:Times New Roman,Times,serif;font-size: 10pt;">
			<font style="display:inline;font-family:Times New Roman,Times,serif;">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. </font><font style="display:inline;font-family:Segoe UI Symbol;">&#x2612;</font>
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			<font style="display:inline;font-size:5pt;">&nbsp;</font>
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			<font style="display:inline;font-size:1pt;">&nbsp;</font>
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			&nbsp;
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			<font style="display:inline;"></font></p></div><div style="margin-left:10.2941176470588%;margin-right:10.2941176470588%;">
		<p><font size="1"> </font></p></div><div style="margin-left:10.2941176470588%;margin-right:10.2941176470588%;page-break-after:always;"><div style="background-color:#000000;clear:both;height:2pt;border:0;margin:30pt 0pt 30pt 0pt;"></div></div><div style="margin-left:10.2941176470588%;margin-right:10.2941176470588%;"></div><div style="margin-left:10.2941176470588%;margin-right:10.2941176470588%;"><p style="margin:0pt;font-family:Times New Roman,Times,serif;font-size: 10pt;"><font style="display:inline;"></font>
		</p>
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			<font style="display:inline;">&nbsp;</font>
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		<p style="margin:0pt;font-family:Times New Roman,Times,serif;font-size: 10pt;">
			<font style="display:inline;font-family:Times New Roman,Times,serif;font-weight:bold;color:#000000;">Item&nbsp;8.01.&nbsp; Other Events.</font>
		</p>
		<p style="margin:0pt;font-family:Times New Roman,Times,serif;font-size: 10pt;">
			<font style="display:inline;">&nbsp;</font>
		</p>
		<p style="margin:0pt;color:#000000;font-family:Times New Roman,Times,serif;font-size: 10pt;">
			<font style="display:inline;font-family:Times New Roman,Times,serif;color:#000000;">On May 26, 2020, Kala Pharmaceuticals,&nbsp;Inc. (the &#x201C;Company&#x201D;) issued a press release announcing that the U.S. Food and Drug Administration (&#x201C;FDA&#x201D;) has acknowledged receipt of the Company&#x2019;s New Drug Application (&#x201C;NDA&#x201D;) resubmission for marketing approval of EYSUVIS</font><font style="display:inline;font-family:Times New Roman,Times,serif;color:#000000;font-size:5pt;top:-4pt;position:relative;line-height:100%">TM</font><font style="display:inline;font-family:Times New Roman,Times,serif;color:#000000;"> (loteprednol etabonate ophthalmic suspension) 0.25%, its product candidate for the short-term treatment of the signs and symptoms of dry eye disease. In the acknowledgement letter for the resubmitted NDA, the FDA stated that the NDA resubmission is a complete, Class 2 response to the Complete Response Letter the FDA issued in August 2019, and the FDA set a Prescription Drug User Fee Act (&#x201C;PDUFA&#x201D;) goal date of October 30, 2020 for the completion of its review of the NDA.</font>
		</p>
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			<font style="display:inline;">&nbsp;</font>
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			<font style="display:inline;font-family:Times New Roman,Times,serif;font-weight:bold;"></font>
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			<font style="display:inline;"></font></p></div><div style="margin-left:10.2941176470588%;margin-right:10.2941176470588%;">
		<p><font size="1"> </font></p></div><div style="margin-left:10.2941176470588%;margin-right:10.2941176470588%;page-break-after:always;"><div style="background-color:#000000;clear:both;height:2pt;border:0;margin:30pt 0pt 30pt 0pt;"></div></div><div style="margin-left:10.2941176470588%;margin-right:10.2941176470588%;"></div><div style="margin-left:10.2941176470588%;margin-right:10.2941176470588%;"><p style="margin:0pt;font-family:Times New Roman,Times,serif;font-size: 10pt;"><font style="display:inline;"></font>
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		<p style="margin:0pt;text-align:center;font-family:Times New Roman,Times,serif;font-size: 10pt;">
			<font style="display:inline;">&nbsp;</font>
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		<p style="margin:0pt;text-align:center;font-family:Times New Roman,Times,serif;font-size: 10pt;">
			<font style="display:inline;font-family:Times New Roman,Times,serif;font-weight:bold;">SIGNATURES</font>
		</p>
		<p style="margin:0pt;font-family:Times New Roman,Times,serif;font-size: 10pt;">
			<font style="display:inline;">&nbsp;</font>
		</p>
		<p style="margin:0pt;text-indent:36pt;font-family:Times New Roman,Times,serif;font-size: 10pt;">
			<font style="display:inline;font-family:Times New Roman,Times,serif;">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.</font>
		</p>
		<p style="margin:0pt;font-family:Times New Roman,Times,serif;font-size: 10pt;">
			<font style="display:inline;">&nbsp;</font>
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			<font style="display:inline;">&nbsp;</font>
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					<p style="margin:0pt;font-family:Times New Roman,Times,serif;font-size: 10pt;">
						<font style="display:inline;font-family:Times New Roman,Times,serif;">KALA PHARMACEUTICALS,&nbsp;INC.</font></p>
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					<p style="margin:0pt;font-family:Times New Roman,Times,serif;font-size: 10pt;">
						<font style="display:inline;font-family:Times New Roman,Times,serif;">Date: May 26, 2020</font></p>
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					<p style="margin:0pt;font-family:Times New Roman,Times,serif;font-size: 10pt;">
						<font style="display:inline;font-family:Times New Roman,Times,serif;">By:</font></p>
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					<p style="margin:0pt;font-family:Times New Roman,Times,serif;font-size: 10pt;">
						<font style="display:inline;font-family:Times New Roman,Times,serif;">/s/ Eric L. Trachtenberg </font></p>
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						<font style="display:inline;font-family:Times New Roman,Times,serif;">&nbsp;</font></p>
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						<font style="display:inline;font-family:Times New Roman,Times,serif;">&nbsp;</font></p>
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					<p style="margin:0pt;font-family:Times New Roman,Times,serif;font-size: 10pt;">
						<font style="display:inline;font-family:Times New Roman,Times,serif;">Name: Eric L. Trachtenberg</font></p>
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						<font style="display:inline;font-family:Times New Roman,Times,serif;">Title: General Counsel, Chief Compliance Officer <br></font><font style="display:inline;"></font><font style="display:inline;font-family:Times New Roman,Times,serif;">&amp; Corporate Secretary</font></p>
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			<font style="display:inline;">&nbsp;</font>
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{"company-data": {"conformed-name": "Kala Pharmaceuticals, Inc.", "cik": "0001479419", "assigned-sic": "2834", "irs-number": "270604595", "state-of-incorporation": "DE", "fiscal-year-end": "1231"}, "filing-values": {"form-type": "8-K", "act": "34", "file-number": "001-38150", "film-number": "20908181"}, "business-address": {"street1": "490 ARSENAL WAY", "street2": "SUITE 120", "city": "WATERTOWN", "state": "MA", "zip": "02472", "phone": "781-996-5252"}, "mail-address": {"street1": "490 ARSENAL WAY", "street2": "SUITE 120", "city": "WATERTOWN", "state": "MA", "zip": "02472"}}
kala_Current_Folio_8K
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):
May 26, 2020
Kala Pharmaceuticals, Inc.
(Exact Name of Company as Specified in its Charter)
Delaware
001-38150
27-0604595
(State or Other Jurisdiction of Incorporation)
(Commission File Number)
(IRS Employer Identification No.)
490 Arsenal Way, Suite 120
Watertown, MA 02472
(Address of Principal Executive Offices) (Zip Code)
Company's telephone number, including area code:
(781) 996-5252
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, $0.001 par value per share
KALA
The Nasdaq Global Select Market
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
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 May 26, 2020, Kala Pharmaceuticals, Inc. (the "Company") issued a press release announcing that the U.S. Food and Drug Administration ("FDA") has acknowledged receipt of the Company's New Drug Application ("NDA") resubmission for marketing approval of EYSUVIS
TM
(loteprednol etabonate ophthalmic suspension) 0.25%, its product candidate for the short-term treatment of the signs and symptoms of dry eye disease. In the acknowledgement letter for the resubmitted NDA, the FDA stated that the NDA resubmission is a complete, Class 2 response to the Complete Response Letter the FDA issued in August 2019, and the FDA set a Prescription Drug User Fee Act ("PDUFA") goal date of October 30, 2020 for the completion of its review of the NDA.
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.
KALA PHARMACEUTICALS, INC.
Date: May 26, 2020
By:
/s/ Eric L. Trachtenberg
Name: Eric L. Trachtenberg
Title: General Counsel, Chief Compliance Officer
& Corporate Secretary