<SEC-DOCUMENT>0001144204-18-066309.txt : 20190411
<SEC-HEADER>0001144204-18-066309.hdr.sgml : 20190411
<ACCEPTANCE-DATETIME>20181227092032
<PRIVATE-TO-PUBLIC>
ACCESSION NUMBER:		0001144204-18-066309
CONFORMED SUBMISSION TYPE:	CORRESP
PUBLIC DOCUMENT COUNT:		2
FILED AS OF DATE:		20181227

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:		CORRESP

	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>
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<FILENAME>filename1.htm
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<P STYLE="margin: 0">&nbsp;&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left"><IMG SRC="image_004.gif" ALT="">&nbsp;</P>

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left">December 27, 2018</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">U.S. Securities and Exchange Commission</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Mail Stop 4720</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">100 F Street, N.E.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Washington, D.C. &nbsp;20549</P>

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

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    <TD STYLE="padding-left: 0; text-indent: 0; width: 1in">Re:</TD>
    <TD STYLE="padding-left: 0; text-indent: 0"><U>Protalix BioTherapeutics, Inc.</U></TD></TR>
</TABLE>


<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 1in"><U>Form 10-K for the Fiscal Year Ended December
31, 2017</U></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in"><U>Filed March 6, 2018</U><BR>
<U>Form 10-Q for the Quarterly Period Ended September 30, 2018</U></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in"><U>Filed November 7, 2018</U></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in"><U>File No. 001-33357</U></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Ladies and Gentlemen:</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: left">Transmitted herewith is the response of Protalix
BioTherapeutics, Inc. to the Staff&rsquo;s comments to our Annual Report on Form 10-K for the fiscal year ended December&nbsp;31,
2017 (the &ldquo;Form 10-K&rdquo;) and Quarterly Report on Form 10-Q for the quarterly period ended September&nbsp;30, 2018 (the
&ldquo;Form 10-Q&rdquo;), which comments were set forth in the Staff&rsquo;s letter dated December&nbsp;4, 2018 (the &ldquo;Comment
Letter&rdquo;) to Yossi Maimon, our Chief Financial Officer. For ease of reference, we have noted the Staff&rsquo;s comments in
bold-faced type and the responses in regular type.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left"><B>Notes to the Consolidated Financial Statements</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left"><B>d. Revenue Recognition, page 8</B></P>

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

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

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.5in; text-align: center; vertical-align: top">1.</TD><TD><B>You state that the development and manufacturing services for the Chiesi agreements are viewed as a single performance obligation
and therefore the upfront payments, future research and development reimbursement payments and any potential additional development
milestone payments under each agreement will be deferred until the commencement of commercial manufacturing. Please address the
following:</B></TD></TR></TABLE>

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

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.5in"></TD><TD STYLE="width: 0.5in"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD STYLE="text-align: left"><B>Identify for us each of the promised goods or services in these agreements including the transfers
of licenses and explain how you determined that you only had a single performance obligation under the guidance in ASC 606-10-25-14.</B></TD></TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in; text-align: left"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in; text-align: left"><B></B></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in; text-align: left"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: left"><U>Response</U>: Protalix Ltd.,
our wholly-owned subsidiary, develops recombinant therapeutic proteins based on its proprietary ProCellEx<SUP>&reg;</SUP> protein
expression system. ProCellEx is a production system based on plant cell culture technology for the development, expression and
manufacture of recombinant proteins. Protalix Ltd.&rsquo;s research and development activities target the development of drugs
to treat certain diseases using its unique technology in the manufacturing process of the drugs. It is the first company to gain
U.S. Food and Drug Administration approval of a protein produced through plant cell-based expression. The ProCellEx platform is
a proven alternative to mammalian cell-based production technology (the most common form of recombinant protein production), overcoming
many of the disadvantages of mammalian cell-based production while offering significant production, regulatory and cost advantages.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: left">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: left">Protalix Ltd. has entered into
two separate agreements with Chiesi Farmaceutici S.p.A. (&ldquo;Chiesi&rdquo;) with respect to the license and supply of pegunigalsidase
alfa, our drug candidate for the treatment of Fabry disease that currently is under advanced stages of clinical development (the
&ldquo;drug&rdquo; or the &ldquo;product&rdquo;): the Exclusive License and Supply Agreement dated as of October 17, 2017 covering
all territories outside of the United States and the Exclusive U.S. License and Supply Agreement dated as of July 23, 2018 covering
the United States (collectively, the &ldquo;Chiesi Agreements&rdquo;). Under the terms of the Chiesi Agreements, the parties have
agreed to the following:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: left">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: left; text-indent: 0.25in">i)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;License
&ndash; Chiesi was granted exclusive, non-transferrable, worldwide license rights to commercialize pegunigalsidase alfa. Chiesi
was not granted any other rights to, or benefits from, the intellectual property of Protalix Ltd. (the &ldquo;IP&rdquo;).</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: left; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: left; text-indent: 0.25in">ii)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Clinical
development &ndash; Protalix Ltd. is responsible for continuing the actual clinical development of the product in order to obtain
regulatory approvals for the drug. Chiesi did not receive any right to use the clinical data other than for commercialization purposes.
Hence, Chiesi does not have the right to use the results of Protalix Ltd.&rsquo;s clinical development activities with respect
to the product for its own research and development activities in other areas or for other products.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: left; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: left; text-indent: 0.25in">iii)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Manufacturing
and supply &ndash; After a regulatory approval for the drug is obtained, Protalix is required to manufacture and supply the drug
to Chiesi based on Chiesi&rsquo;s purchase orders. Chiesi will have no other way to obtain the product other than purchasing the
product from Protalix Ltd.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: left; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: left">ASC 606-10-25-14 states:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: left">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: left">&ldquo;At contract inception, an
entity shall assess the goods or services promised in a contract with a customer and shall identify as a performance obligation
each promise to transfer to the customer either:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: left">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.5in"></TD><TD STYLE="width: 0.5in">a.</TD><TD STYLE="text-align: left"><FONT STYLE="font-size: 10pt">A good or service (or a bundle of goods or services) that is distinct.</FONT></TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.5in; padding-left: 0; text-indent: 0">&nbsp;</TD>
    <TD STYLE="text-align: left; padding-left: 0; text-indent: 0; width: 0.5in">b.<FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></TD>
    <TD STYLE="text-align: left; padding-left: 0; text-indent: 0">A series of distinct goods or services that are substantially the same and that have the same pattern of transfer to the customer
(see paragraph&nbsp;606-10-25-15).&rdquo;</TD></TR>
</TABLE>


<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: left; background-color: white">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: left; background-color: white"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: left; background-color: white">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: left">ASC 606-10-25-17 states:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: left">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: left">&ldquo;Performance obligations
do not include activities that an entity must undertake to fulfill a contract unless those activities transfer a good or service
to a customer.&rdquo;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: left">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: left">ASC 606-10-25-19 states:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: left">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: left">&ldquo;A good or service that is
promised to a customer is distinct if both of the following criteria are met:</P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.5in"></TD><TD STYLE="width: 0.5in">a.</TD><TD STYLE="text-align: left">The customer can benefit from the good or service either on its own or together with other resources
that are readily available to the customer (that is, the good or service is capable of being distinct).</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.5in"></TD><TD STYLE="width: 0.5in">b.</TD><TD STYLE="text-align: left">The entity&rsquo;s promise to transfer the good or service to the customer is separately identifiable
from other promises in the contract (that is, the promise to transfer the good or service is distinct within the context of the
contract).&rdquo;</TD></TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: left">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: left">ASC 606-10-25-20 states:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: left">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: left">&ldquo;A customer can benefit from
a good or service in accordance with paragraph 606-10-25-19(a) if the good or service could be used, consumed, sold for an amount
that is greater than scrap value, or otherwise held in a way that generates economic benefits...&rdquo;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: left">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: left">The grant of non-transferrable
commercialization rights and Protalix Ltd.&rsquo;s commitment to complete the clinical development of the drug are not distinct
actions and do not transfer any benefit to Chiesi prior to the commencement of commercial production of the drug, for the following
reasons:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: left">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.5in"></TD><TD STYLE="width: 0.5in"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD STYLE="text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif">Chiesi cannot benefit from the license on
its own or together with other available resources. Chiesi does not have sublicensing rights (except for certain small territories)
and has neither the right, the ability nor the know-how to continue the clinical development of the product (subject to certain,
limited exceptions). Therefore, the license is not distinct.</FONT></TD></TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in; text-align: left; text-indent: -0.5in">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.5in"></TD><TD STYLE="width: 0.5in"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD STYLE="text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif">Completion of the clinical development is
a condition precedent to Chiesi&rsquo;s ultimate sale of the product. Chiesi cannot benefit in any other manner from the clinical
development activities performed by Protalix Ltd. as Chiesi does not have the right to use any information obtained from Protalix
Ltd.&rsquo;s clinical development efforts, or from the license granted to Chiesi to use the clinical development information, for
other indications that could be developed from the IP. Protalix Ltd. continues to be the owner of the IP and to be entitled to
use the IP for its research and development activities in other areas and for the development of other drugs. Therefore, the clinical
development activities are not capable of being distinct.</FONT></TD></TR></TABLE>

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

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.5in"></TD><TD STYLE="width: 0.5in"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD STYLE="text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif">Chiesi is obligated to acquire the product
from Protalix Ltd. It cannot generate economic benefits from the commercialization license or from the completion of the clinical
development in any way except from the ability to sell the finished product, which must be purchased from Protalix Ltd. Since the
unique manufacturing process is crucial to the drug and only Protalix Ltd. can perform the manufacturing, no one else can produce
the product and/or complete the clinical development. </FONT></TD></TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: left">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: left"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: left">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: left">Based on the above, the criterion
in paragraph 606-10-25-19(a) is not met. Consequently, the license, the clinical development and the manufacturing services are
not distinct activities and thus, we have accounted for the Chiesi Agreements as a single performance obligation. <U>See also</U>
Example 56 to ASC 606 &mdash;&ldquo;Identifying a Distinct License &ndash; case A&rdquo;.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: left">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: left">In substance, we deem the Chiesi
Agreements to be a transfer of specifically defined commercialization rights and a supply agreement for a drug pending approval
in exchange for Chiesi&rsquo;s upfront contributions to Protalix Ltd.&rsquo;s development costs, and additional payments of the
ongoing purchase price of the product as stipulated in the Chiesi Agreements.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: left">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.5in"></TD><TD STYLE="width: 0.5in"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD STYLE="text-align: left"><B>With reference to ASC 606-10-25-23 to 25-26, explain to us why revenue is deferred until commencement
of commercial manufacturing and how you considered that you have already transferred the licenses and begun providing development
services.</B></TD></TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in; text-align: left"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: left"><U>Response</U>: As described above,
based on the unique facts and the terms of the Chiesi Agreements, we believe that each of the Chiesi Agreements should be viewed
as a commercialization and distribution agreement as Chiesi will benefit from an agreement only upon the purchase of the drug from
Protalix Ltd. and the subsequent sales of the drug.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: left">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: left">Neither the grant of the license
to commercialize the drug nor the continuation of the clinical development transfers any goods or services to Chiesi and, therefore,
neither of these activities qualifies as a distinct performance obligation of Protalix Ltd.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: left">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: left">Protalix Ltd. will start satisfying
its performance obligation only upon supply of the drug after issuance of regulatory marketing approvals. All consideration received
and to be received up to the commercialization phase relates to the ultimate supply of product to Chiesi and therefore are deferred
and recognized only upon satisfaction of a single performance obligation, which is the supply of the drug.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in; text-align: left"><B>&nbsp;</B></P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0.5in"></TD><TD STYLE="width: 0.5in"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD STYLE="text-align: left"><B>Explain to us whether you intend to recognize revenue over time or at a point in time, and why
with reference to ASC 606-10-25-30 or 25-31, as applicable.</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 0pt 0.25in; text-align: left"><U>Response</U>: As described above,
we intend to begin recognizing revenue when entering into the commercial manufacturing/supply phase as product is delivered to
Chiesi for commercial purposes. At that date, we intend to estimate the forecasted quantity of the drug to be supplied over the
term of the Chiesi Agreements. Deferred revenue will be recognized based on the quantity supplied out of the total expected quantity.
Hence, we intend to recognize revenue at a point in time at which Chiesi achieves control over batches supplied.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: left">We intend to evaluate the need to expand the related disclosure
in our financial statements included in future filings in order to further clarify the rational for the accounting for the consideration
received under the Chiesi Agreements and the related revenue recognition.</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">*&#9;*&#9;*</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"></P>

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<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 0pt 0.25in; text-align: left">We thank you in advance for your time and attention to this
response letter. Should you wish to discuss this response letter at any time, please do not hesitate to contact me at +972 (4)
902-8100 or YossiM@protalix.com or our counsel, Brian Hirshberg of Mayer Brown LLP at +1 (212) 506-2176 or bhirshberg@mayerbrown.com.</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 0pt 0.25in; text-align: left">Sincerely,</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 0pt 0.25in; text-align: left">/s/ Yossi Maimon<BR>
Yossi Maimon<BR>
Vice President and Chief Financial Officer<BR>
Protalix BioTherapeutics, Inc.</P>

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

<TABLE CELLPADDING="0" CELLSPACING="0" BORDER="0" STYLE="width: 100%; margin-top: 0pt; margin-bottom: 0pt; font: 10pt Times New Roman, Times, Serif">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="padding-left: 0; text-indent: 0; width: 0.5in">cc:</TD>
    <TD STYLE="padding-left: 0; text-indent: 0">Moshe Manor</TD></TR>
</TABLE>


<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.75in">Protalix BioTherapeutics, Inc.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.75in">Brian Hirshberg</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.75in">Mayer Brown LLP</P>

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

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

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

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