<SEC-DOCUMENT>0001104659-19-064875.txt : 20191118
<SEC-HEADER>0001104659-19-064875.hdr.sgml : 20191118
<ACCEPTANCE-DATETIME>20191118065717
ACCESSION NUMBER:		0001104659-19-064875
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20191118
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20191118
DATE AS OF CHANGE:		20191118

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Protalix BioTherapeutics, Inc.
		CENTRAL INDEX KEY:			0001006281
		STANDARD INDUSTRIAL CLASSIFICATION:	BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
		IRS NUMBER:				650643773
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-33357
		FILM NUMBER:		191226131

	BUSINESS ADDRESS:	
		STREET 1:		2 SNUNIT ST
		STREET 2:		SCIENCE PARK, POB 455
		CITY:			CARMIEL
		STATE:			L3
		ZIP:			20100
		BUSINESS PHONE:		972-4-988-9488

	MAIL ADDRESS:	
		STREET 1:		2 SNUNIT ST
		STREET 2:		SCIENCE PARK, POB 455
		CITY:			CARMIEL
		STATE:			L3
		ZIP:			20100

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	ORTHODONTIX INC
		DATE OF NAME CHANGE:	19980422

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	EMBASSY ACQUISITION CORP
		DATE OF NAME CHANGE:	19960124
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
<SEQUENCE>1
<FILENAME>tm1922907d1_8k.htm
<DESCRIPTION>FORM 8-K
<TEXT>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>UNITED STATES</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>SECURITIES AND EXCHANGE COMMISSION</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>Washington, D.C.
20549&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; text-align: center; margin-bottom: 0pt"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; text-align: center; margin-bottom: 0pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>FORM 8-K</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; text-align: center; margin-bottom: 0pt">&nbsp;</P>



<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; text-align: center; margin-bottom: 0pt"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; text-align: center; margin-bottom: 0pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>CURRENT REPORT </B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>Pursuant to Section 13 or 15(d) of </B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>the Securities Exchange Act of 1934 </B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; text-align: center; margin-bottom: 0pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>Date of Report (Date of Earliest Event
Reported): November</B>&nbsp;<B>18, 2019</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>&nbsp;</B></P>



<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; text-align: center; margin-bottom: 0pt"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; text-align: center; margin-bottom: 0pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><FONT STYLE="font-size: 14pt"><B>Protalix
BioTherapeutics, Inc.</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>(Exact name of registrant as specified
in its charter) </B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; text-align: center; margin-bottom: 0pt">&nbsp;</P>

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<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
<TR>
    <TD STYLE="text-align: center; width: 33%">&nbsp;</TD>
    <TD STYLE="text-align: center; width: 34%">&nbsp;</TD>
    <TD STYLE="text-align: center; width: 33%">&nbsp;</TD></TR>
<TR>
    <TD STYLE="vertical-align: top; text-align: center"><B>Delaware</B></TD>
    <TD STYLE="vertical-align: top; text-align: center"><B>001-33357</B></TD>
    <TD STYLE="vertical-align: top; text-align: center"><B>65-0643773</B></TD></TR>
<TR>
    <TD STYLE="vertical-align: top; text-align: center">
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>(State or other jurisdiction</B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>of incorporation)</B></P></TD>
    <TD STYLE="vertical-align: top; text-align: center"><B>(Commission File Number)</B></TD>
    <TD STYLE="vertical-align: top; text-align: center">
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>(IRS Employer</B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>Identification
No.)</B></P></TD></TR>
<TR>
    <TD STYLE="text-align: center">&nbsp;</TD>
    <TD COLSPAN="2" STYLE="text-align: center">&nbsp;</TD></TR>
<TR>
    <TD STYLE="vertical-align: top; text-align: center"><B>2 Snunit Street</B></TD>
    <TD COLSPAN="2" STYLE="vertical-align: top; text-align: center"></TD></TR>
<TR>
    <TD STYLE="vertical-align: top; text-align: center"><B>Science Park, POB 455</B></TD>
    <TD COLSPAN="2" STYLE="vertical-align: top; text-align: center">&nbsp;</TD></TR>
<TR>
    <TD STYLE="vertical-align: top; text-align: center"><B>Carmiel, Israel</B></TD>
    <TD COLSPAN="2" STYLE="vertical-align: top; text-align: center"><B>20100</B></TD></TR>
<TR>
    <TD STYLE="vertical-align: top; text-align: center"><B>(Address of principal executive offices)</B></TD>
    <TD COLSPAN="2" STYLE="vertical-align: top; text-align: center"><B>(Zip Code)</B></TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; text-align: center; margin-bottom: 0pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>Registrant&rsquo;s telephone number,
including area code +972-4-988-9488</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; text-align: center; margin-bottom: 0pt">&nbsp;&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>(Former name or former address, if changed
since last report.) </B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>




<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">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 (<I>see</I> General Instruction
A.2. below):</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0in"></TD><TD STYLE="width: 0.25in; text-align: left"><FONT STYLE="font-family: Wingdings">&#168;</FONT></TD><TD STYLE="text-align: justify">Written communication pursuant to Rule 425 under the
Securities Act (17 CFR 230.425)</TD>
</TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0in"></TD><TD STYLE="width: 0.25in; text-align: left"><FONT STYLE="font-family: Wingdings">&#168;</FONT></TD><TD STYLE="text-align: justify">Soliciting material pursuant to Rule 14a-12 under the
Exchange Act (17 CFR 240.14a-12)</TD>
</TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0in"></TD><TD STYLE="width: 0.25in; text-align: left"><FONT STYLE="font-family: Wingdings">&#168;</FONT></TD><TD STYLE="text-align: justify">Pre-commencement communications pursuant to Rule 14d-2(b)
under the Exchange Act (17 CFR 240.14d-2(b))</TD>
</TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0in"></TD><TD STYLE="width: 0.25in; text-align: left"><FONT STYLE="font-family: Wingdings">&#168;</FONT></TD><TD STYLE="text-align: justify">Pre-commencement communications pursuant to Rule 13e-4(c)
under the Exchange Act (17 CFR 240.13e-4(c))</TD>
</TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Securities registered pursuant to Section
12(b) of the Act:</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
<TR STYLE="vertical-align: bottom">
    <TD STYLE="width: 39%; border: Black 1pt solid; padding-right: 5.4pt; padding-left: 5.4pt; text-align: center">Title of each class</TD>
    <TD STYLE="width: 18%; border-top: Black 1pt solid; border-right: Black 1pt solid; border-bottom: Black 1pt solid; padding-right: 5.4pt; padding-left: 5.4pt; text-align: center">Trading Symbol(s)</TD>
    <TD STYLE="width: 43%; border-top: Black 1pt solid; border-right: Black 1pt solid; border-bottom: Black 1pt solid; padding-right: 5.4pt; padding-left: 5.4pt; text-align: center">Name of each exchange on which registered</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="border-right: Black 1pt solid; border-bottom: Black 1pt solid; border-left: Black 1pt solid; padding-right: 5.4pt; padding-left: 5.4pt; text-align: center">Common stock, $0.001 par value</TD>
    <TD STYLE="border-right: Black 1pt solid; border-bottom: Black 1pt solid; padding-right: 5.4pt; padding-left: 5.4pt; text-align: center">PLX</TD>
    <TD STYLE="border-right: Black 1pt solid; border-bottom: Black 1pt solid; padding-right: 5.4pt; padding-left: 5.4pt; text-align: center">NYSE American</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0.3in 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0.3in 0pt 0">Indicate by check mark whether the registrant is an
emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR &sect;230.405) or Rule 12b-2 of the Securities
Exchange Act of 1934 (17 CFR &sect;240.12b-2).</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0.3in 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 4in; text-align: right; text-indent: 0.5in">Emerging growth
company <FONT STYLE="font-family: Wingdings">&#168;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 4in; text-align: center; text-indent: 0.5in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">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 STYLE="font-family: Wingdings">&#168;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 13%"><B>Item 8.01</B></TD>
    <TD STYLE="width: 87%"><B>Other Events</B></TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">On November&nbsp;18, 2019, Protalix BioTherapeutics, Inc. (the
 &ldquo;Company&rdquo;) issued a press release announcing, together with its development and commercialization partner, Chiesi
Farmaceutici S.p.A., that they have completed a successful Type B Pre-Biologics License Application (BLA) meeting with the U.S.&nbsp;Food
and Drug Administration (FDA) regarding the Accelerated Approval pathway for pegunigalsidase alfa (PRX-102) for the treatment
of Fabry disease. Pegunigalsidase alfa is the Company&rsquo;s investigational, plant cell culture expressed, and chemically modified
stabilized version of, the recombinant alpha-Galactosidase-A enzyme. A copy of the press release is attached as Exhibit&nbsp;99.1
to this Current Report on Form 8-K and is incorporated herein by reference.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 12%; text-align: left; vertical-align: top"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>
</B></FONT><B>Item 9.01</B></TD>
    <TD STYLE="width: 88%; text-align: left; vertical-align: top"><B>Financial Statements and Exhibits</B></TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0in"></TD><TD STYLE="width: 0.5in; text-align: left"><B>(d)</B></TD><TD STYLE="text-align: justify"><B>Exhibits</B></TD>
</TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0in"></TD><TD STYLE="width: 0.5in; text-align: left"><A HREF="tm1922907d1_ex99-1.htm" STYLE="-sec-extract: exhibit">99.1</A></TD><TD STYLE="text-align: justify"><A HREF="tm1922907d1_ex99-1.htm" STYLE="-sec-extract: exhibit">Press release dated November&nbsp;18, 2019.</A></TD>
</TR></TABLE>

<P STYLE="margin-top: 0; margin-bottom: 0">&nbsp;</P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>SIGNATURES</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">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>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; background-color: white">
<TR>
    <TD STYLE="text-align: left; vertical-align: top">Date: November&nbsp;18, 2019</TD>
    <TD COLSPAN="3" STYLE="text-align: left; vertical-align: top"><B>PROTALIX BIOTHERAPEUTICS, INC.</B></TD></TR>
<TR>
    <TD STYLE="text-align: left; vertical-align: top">&nbsp;</TD>
    <TD COLSPAN="3" STYLE="text-align: left; vertical-align: top">&nbsp;</TD></TR>
<TR>
    <TD STYLE="text-align: left; vertical-align: top">&nbsp;</TD>
    <TD STYLE="text-align: left; vertical-align: top">By:</TD>
    <TD COLSPAN="2" STYLE="text-align: left; vertical-align: top">
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; border-bottom: Black 0.5pt solid">/s/ Dror
        Bashan</P></TD></TR>
<TR>
    <TD STYLE="text-align: left; width: 50%; vertical-align: top">&nbsp;</TD>
    <TD STYLE="text-align: left; width: 5%; vertical-align: top">&nbsp;</TD>
    <TD STYLE="width: 5%; text-align: left; vertical-align: top">Name: </TD>
    <TD STYLE="width: 40%; text-align: left; vertical-align: top">Dror Bashan</TD></TR>
<TR>
    <TD STYLE="text-align: left; vertical-align: top">&nbsp;</TD>
    <TD STYLE="text-align: left; vertical-align: top">&nbsp;</TD>
    <TD STYLE="text-align: left; vertical-align: top">Title:</TD>
    <TD STYLE="text-align: left; vertical-align: top">President and <BR>
Chief Executive Officer</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 3.5in; text-align: justify; text-indent: -3.5in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 3.5in; text-align: justify; text-indent: -3.5in"></P>

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<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>tm1922907d1_ex99-1.htm
<DESCRIPTION>EXHIBIT 99.1
<TEXT>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: right"><B>Exhibit 99.1</B>&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;<IMG SRC="logo.gif" ALT=""></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Protalix BioTherapeutics and Chiesi Farmaceutici
Announce Successful pre-BLA Meeting with FDA for Accelerated Approval of<BR>
pegunigalsidase alfa for the Treatment of Fabry Disease in the United States</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><I>FDA indicated that existing clinical
data, nonclinical data, safety database and manufacturing data will support a Biologics License Application submission</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><I>No additional clinical trials are necessary
for BLA submission, expected by April of 2020</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white"><B>CARMIEL,&nbsp;Israel</B>,&nbsp;November&nbsp;18,
2019&nbsp;--&nbsp;Protalix BioTherapeutics, Inc.&nbsp;(NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on
the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx<SUP>&reg;</SUP>
plant cell-based protein expression system, and its development and commercialization partner, Chiesi Farmaceutici S.p.A., an international
research-focused healthcare Group (Chiesi), today announced that they have completed a successful Type B Pre-Biologics License
Application (BLA) meeting with the U.S.&nbsp;Food and Drug Administration (FDA) regarding the Accelerated Approval pathway for
pegunigalsidase alfa (PRX-102) for the treatment of Fabry disease.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">The Company, together with Chiesi, met with the FDA on October
15 to discuss key information on pegunigalsidase alfa to be included in a proposed BLA filing under the Accelerated Approval pathway.
The Company and Chiesi report that they have reached alignment with the FDA on the Accelerated Approval pathway for pegunigalsidase
alfa. The BLA, as expected to be submitted to the FDA, will include data from the Company&rsquo;s completed phase I/II clinical
trials of pegunigalsidase alfa and from its ongoing phase&nbsp;III BRIDGE clinical trial.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&ldquo;The confirmation by the FDA regarding the proposed BLA
submission, together with the finalization of the BALANCE study enrollment (78 patients) and the very promising interim results
from the BRIDGE study, are three recent significant consecutive milestones achieved with respect to our Fabry late-stage clinical
program,&rdquo; said Dror Bashan, Protalix&rsquo;s President and Chief Executive Officer. &ldquo;We are committed to the completion
of this program with positive results for the benefit of the Fabry patient community.&rdquo;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">The Company and Chiesi also announced that they have reached
an agreement with the FDA regarding the ongoing BALANCE study, as currently designed, serving as the confirmatory trial for PRX-102.
A confirmatory trial is required to convert a BLA approved under Accelerated Approval into a traditional approval.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">The Company and Chiesi expect to submit the BLA to the FDA by
April of 2020. The FDA indicated that the nonclinical data, the clinical data, the safety database and manufacturing data are sufficient
to support the BLA submission, and that no additional clinical trials will be required for the proposed BLA submission. The Company
and Chiesi expect that the fully electronic BLA submission will include a comprehensive set of preclinical, clinical and manufacturing
related information on pegunigalsidase alfa. If approved, the Company will be eligible to receive a milestone payment from Chiesi.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&ldquo;We have now had three successful interactions with the
FDA during 2019, which built on our long-term relationship with the Agency and made our regulatory path forward for pegunigalsidase
alfa clear,&rdquo; said Dr. Einat Almon, Protalix&rsquo;s Senior Vice President, Product Development. &ldquo;We expect that alignment
with the FDA on the Accelerated Approval pathway for pegunigalsidase alfa results in our being significantly closer to bringing
an approved product to market to help Fabry patients. Together with our partner Chiesi, we look forward to completing the application
process, as well as continuing with our double blind head-to-head phase&nbsp;III BALANCE clinical trial, which we feel will further
strengthen the position of pegunigalsidase alfa within the Fabry patient community.&rdquo;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>About Fabry Disease</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Fabry disease is an X-linked inherited disease that results
from deficient activity of the lysosomal enzyme alpha galactosidase A resulting in progressive accumulation of abnormal deposits
of a fatty substance called globotriaosylceramide (Gb<SUB>3</SUB>) in blood vessel walls throughout a person&rsquo;s body. Fabry
disease occurs in one person per 40,000. Fabry patients inherit a deficiency of the enzyme alpha-galactosidase-A, which is normally
responsible for the breakdown of Gb<SUB>3</SUB>. The abnormal storage of Gb<SUB>3</SUB> increases with time and, accordingly, Gb<SUB>3</SUB>
accumulates, primarily in the blood and in the blood vessel walls. The ultimate consequences of Gb<SUB>3</SUB> deposition range
from episodes of pain and impaired peripheral sensation to end-organ failure &ndash; particularly of the kidneys, but also of the
heart and the cerebrovascular system.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white"><B>About pegunigalsidase alfa (PRX</B>-<B>102)</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">The Company&rsquo;s proprietary pegunigalsidase
alfa is an investigational, plant cell culture expressed, and chemically modified stabilized version of, the recombinant alpha-Galactosidase-A
enzyme. Protein sub-units are covalently bound via chemical cross-linking using short PEG moieties, resulting in a molecule with
unique pharmacokinetic parameters. In clinical studies, pegunigalsidase alfa has been observed to have a circulatory half-life
of approximately 80 hours. The Company designed pegunigalsidase alfa to potentially address the continued unmet clinical need in
Fabry patients of continuous disease progression, infusion reactions and immunogenicity.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white"><B>About the Chiesi Group<BR>
</B>Based in Parma, Italy, Chiesi Farmaceutici is an international research-oriented group with over 80 years&rsquo; experience
in the pharmaceutical sector and is present in 28 countries. The Group researches, develops and commercializes innovative medicines
in respiratory disease, special care and rare disease therapeutic areas. The Group&rsquo;s Research &amp; Development center is
integrated with six other important research and development groups in France, the USA, the UK and Sweden, to promote its pre-clinical,
clinical and registration programs. The Group employs around 5,700 people. Chiesi Group is a certified B Corp. For more information,
please visit www.chiesi.com.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white"><B>About&nbsp;Protalix BioTherapeutics,
Inc.</B><BR>
Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed
through its proprietary plant cell-based expression system, ProCellEx<SUP>&reg;</SUP>. Protalix was the first company to gain FDA
approval of a protein produced through a plant cell-based, in suspension expression system. Protalix&rsquo;s unique expression
system represents a new method for developing recombinant proteins in an industrial-scale manner. Protalix&rsquo;s pipeline consists
of proprietary, potentially clinically superior versions of recombinant therapeutic proteins that target established pharmaceutical
markets.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">Protalix&rsquo;s first product manufactured
by ProCellEx, taliglucerase alfa, was approved for marketing by the U.S. Food and Drug Administration (FDA) in May 2012 and, subsequently,
by the regulatory authorities of other countries. Protalix has licensed to Pfizer Inc. the worldwide development and commercialization
rights for taliglucerase alfa, excluding Brazil, where Protalix retains full rights.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">Protalix&rsquo;s development pipeline
includes the following product candidates: pegunigalsidase alfa, a modified version of the recombinant human alpha-GAL-A protein
for the treatment of Fabry disease, in phase III clinical trials (BALANCE, BRIDGE and BRIGHT studies); OPRX-106, an orally delivered
anti-inflammatory treatment, and alidornase alfa, both in phase II clinical trials. Protalix has partnered with Chiesi Farmaceutici
S.p.A., both in the United States and outside the United States, for the development and commercialization of pegunigalsidase alfa.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white"><B>Forward-Looking Statements</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">To the extent that statements in this
press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe-harbor provisions
of the Private Securities Litigation Reform Act of 1995. The terms &ldquo;expect,&rdquo; &ldquo;anticipate,&rdquo; &ldquo;believe,&rdquo;
 &ldquo;estimate,&rdquo; &ldquo;project,&rdquo; &ldquo;plan,&rdquo; &ldquo;should&rdquo; and &ldquo;intend,&rdquo; and other words
or phrases of similar import are intended to identify forward-looking statements. These forward-looking statements are subject
to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the
statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery
and development involve a high degree of risk and the final results of a clinical trial may be different than the preliminary findings
for the clinical trial. Factors that might cause material differences include, among others: risks related to our ability to identify
and complete strategic alternatives on attractive terms or at all within the time period required to regain compliance with the
continued listing standards of the NYSE American; risks related to our ability to continue as a going concern absent a refinancing
or restructuring; risks related to any transactions we may effect in the public or private equity markets to raise capital to finance
future research and development activities, general and administrative expenses and working capital; failure or delay in the commencement
or completion of our preclinical and clinical trials which may be caused by several factors, including: risks that the FDA will
not accept an application for accelerated approval of PRX-102 with the data generated to date or will request additional data or
other conditions of our submission of any application for accelerated approval of PRX-102; slower than expected rates of patient
recruitment; unforeseen safety issues; determination of dosing issues; lack of effectiveness during clinical trials; inability
to monitor patients adequately during or after treatment; and inability or unwillingness of medical investigators and institutional
review boards to follow our clinical protocols; the risk that the results of the clinical trials of our product candidates will
not support our claims of safety or efficacy, that our product candidates will not have the desired effects or will be associated
with undesirable side effects or other unexpected characteristics; risks related to our ability to maintain and manage our relationship
with Chiesi Farmaceutici and any other collaborator, distributor or partner; risks related to the ultimate purchase by Funda&ccedil;&atilde;o
Oswaldo Cruz of alfataliglicerase pursuant to the stated purchase intentions of the Brazilian Ministry of Health of the stated
amounts, if at all; risks related to the successful conclusion of our negotiations with the Brazilian Ministry of Health regarding
the purchase of alfataliglicerase generally; risks related to the amount of our future revenues and expenditures; the risk that
despite the FDA&rsquo;s grant of fast track designation for pegunigalsidase alfa for the treatment of Fabry disease, we may not
experience a faster development process, review or approval compared to applications considered for approval under conventional
FDA procedures; risks related to the FDA&rsquo;s ability to withdraw the fast track designation at any time; risks relating to
our ability to make scheduled payments of the principal of, to pay interest on or to refinance our outstanding notes or any other
indebtedness; our dependence on performance by third party providers of services and supplies, including without limitation, clinical
trial services; delays in our preparation and filing of applications for regulatory approval; delays in the approval or potential
rejection of any applications we file with the FDA or other health regulatory authorities, and other risks relating to the review
process; our ability to identify suitable product candidates; the inherent risks and uncertainties in developing drug platforms
and products of the type we are developing; the impact of development of competing therapies and/or technologies by other companies
and institutions; potential product liability risks, and risks of securing adequate levels of product liability and other necessary
insurance coverage; and other factors described in our filings with the U.S.&nbsp;Securities and Exchange Commission. The statements
in this press release are valid only as of the date hereof and we disclaim any obligation to update this information, except as
may be required by law.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white"><B>&nbsp;</B></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white"><B></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white"><B>Investor Contact<BR>
</B>Chuck Padala, Managing Director<B><BR>
</B>LifeSci Advisors<B><BR>
</B>646-627-8390<B><BR>
</B><FONT STYLE="color: Red">chuck@lifesciadvisors.com</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white"><B>Media Contact<BR>
</B>Doug Russell <B><BR>
</B>LaVoieHealthScience<B><BR>
</B>617-953-0120<B><BR>
</B><FONT STYLE="color: Red">drussell@lavoiehealthscience.com</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>###</B></P>



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