Exhibit
10.3


 


[***]
Represents material that has been omitted and will be filed separately with the Securities and Exchange Commission pursuant to
a request for confidential treatment under Rule 24b-2 of the Securities and Exchange Act of 1934, as amended.


 


TECHNOLOGY
TRANSFER AND SUPPLY AGREEMENT


 


This
TECHNOLOGY TRANSFER AND SUPPLY AGREEMENT (this “AGREEMENT”) is made as of _________ __, 2013 by and between PROTALIX
LTD., a limited liability company incorporated under the laws of Israel with offices located at 2 Snunit Street, Science Park,
P.O.B 455, Carmiel 20100, Israel (“PROTALIX”), and FUNDAÇÃO OSWALDO CRUZ, an agency of the Brazilian
Ministry of Health organized under the laws of Brazil, including its manufacturing unit “BIO-MANGUINHOS”, with registered
offices at Avenida Brasil, 4365, Manguinhos, Rio de Janeiro, RJ, Cep 21045-900, Brazil, CGC NI 33.781.055/0001-35, represented
by its President, Dr. PAULO ERNANI GADELHA VIEIRA, hereinafter collectively referred to as "FIOCRUZ". For the purposes
of this AGREEMENT, PROTALIX and FIOCRUZ each are referred to as a “PARTY” and collectively as the “PARTIES”.


 


WHEREAS,
PROTALIX owns or otherwise controls certain patents, patent applications, technology, know-how and scientific and technical
information relating to an enzyme replacement therapy for the treatment of Gaucher Disease; and


 


WHEREAS,
FIOCRUZ is a foundation affiliated with the Ministry of Health of the Brazilian Government and is a manufacturer of vaccines
predominantly for the Brazil National Program of Immunization (“NPI”) which owns,
controls and operates Bio-Manguinhos;


 


WHEREAS,
FIOCRUZ desires to obtain from PROTALIX, and PROTALIX desires to provide to FIOCRUZ, (i) the necessary rights and technical
assistance and information, in various stages, to enable FIOCRUZ to MANUFACTURE and supply the Product
in the Territory (as defined below), and (ii) the SUPPLIED MATERIALS (as
defined below), pursuant to and in accordance with the terms of this AGREEMENT.


 


NOW,
THEREFORE, in consideration of the premises, and the mutual covenants and agreements set forth herein, the PARTIES hereby
agree as follows:


 


ARTICLE
1. DEFINITIONS


 


		1.1	For
                                         purposes of this AGREEMENT, the following terms shall have the meaning ascribed to such
                                         term herein:



 


[***]


 


“ADVISORY
COMMITTEE” shall mean the committee organized and acting pursuant to Article 5.5 which shall have the overall responsibility
for advising on and monitoring the implementation of the TECHNOLOGY TRANSFER up to and including the first successful production
of the FINAL PRODUCT for commercial sale, pursuant to and in accordance with the terms and conditions of this AGREEMENT.


 




    	1



    	 



    

 


“AFFILIATE”
means any entity directly or indirectly controlled by, controlling, or under common control with, a PARTY to this AGREEMENT, but
only for so long as such control shall continue. For purposes of this definition, Article 12.3(d) and Article 20.6 only, “control”
(including, with correlative meanings, “controlled by”, “controlling” and “under common control
with”) means (a) possession, direct or indirect, of the power to direct or cause direction of the management or policies
of an entity (whether through ownership of securities or other ownership interests, by contract or otherwise), or (b) beneficial
ownership of at least 50% of the voting securities or other ownership interest (whether directly or pursuant to any option, warrant
or other similar arrangement) or other comparable equity interests of an entity, it being understood and agreed that for purposes
of clause (a), neither ownership of voting securities or other ownership interests of an entity nor membership or representation
on (if less than half of the members of) an entity’s board of directors shall, by themselves, be presumed to constitute
the power to direct or cause direction of the management or policies of such entity. With respect to the grant of license or other
rights by PROTALIX hereunder, “AFFILIATE” shall exclude any Third PARTY
that becomes an Affiliate due to such Third
PARTY’s acquisition of PROTALIX or any other Person with an ownership
interest in PROTALIX.


 


“ANVISA”
means the National Sanitary Surveillance Agency of the Brazilian Government (or any successor or replacement agency that has the
authority to grant the necessary GOVERNMENTAL APPROVALS).


 


“BULK
PRODUCT” means the DRUG SUBSTANCE component of a PRODUCT in liquid or frozen form.


 


“BUSINESS
DAY” means a day other than a Saturday, Sunday, or bank or other public holiday in Brazil and/or Israel.


 


"CELL
BANK" means a cell bank of vials with carrot cells producing taliglucerase alfa with information on its characterization
and release, as well as information on its origin, plasmid, nature and sequence of the gene used, that is able to provide a sufficient
number of vials for the production of the PRODUCT for a period time not less than 20 years.


 


“CERTIFICATE
OF ACCEPTANCE” means a certificate in the form attached hereto as Appendix III, executed by PROTALIX and FIOCRUZ to confirm
the COMPLETION of each STAGE.


 


“CHALLENGE”
shall have the meaning ascribed to such term in Article 4.8.


 


“COMMERCIALIZATION”
means the marketing, distribution, offering for sale, selling and importation of the PRODUCTS. When used as a verb, “Commercialize”
means to engage in Commercialization.


 


“COMPOUND”
means (a) a plant cell expressed recombinant Glucocerebrosidase enzyme having the sequence set forth in Exhibit A to this
AGREEMENT, and (b) any analogs, derivatives and variants thereof.


 


“COMPLETION”
means the completion of a STAGE after achieving the COMPLETION REQUIREMENTS of such STAGE, as confirmed by the ADVISORY COMMITTEE
and the execution of the CERTIFICATE OF ACCEPTANCE by FIOCRUZ and PROTALIX, evidencing such completion.


 


“COMPLETION
REQUIREMENTS” mean, in relation to each STAGE and the TECHNOLOGY TRANSFER as a whole, the corresponding requirements established
in Article 5.2 and Appendix II for advancement to the next STAGE.


 


“CONFIDENTIAL
INFORMATION” shall have the meaning ascribed to such term in Article 11.1.


 




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“CONTROL”
or “CONTROLLED” means, with respect to any compound, material, Technology,
or intellectual property right, that a PARTY owns or has a license to use, commercialize, manufacture, market, distribute or sell,
and has the ability to grant to the other PARTY access and/or a license or a sublicense (as applicable under this AGREEMENT) to
such compound, material, Technology, or intellectual property right as provided
for herein without violating (a) the terms of any agreement or other arrangements with any Third
PARTY existing before or after the EXECUTION Date or (b) any LAW applicable
to such license or sublicense.


 


“DISCLOSING
PARTY” shall have the meaning ascribed to such term in Article 11.1.


 


“DRUG
SUBSTANCE” means the Compound component of a pharmaceutical drug product.


 


“EFFECTIVE
DATE” shall have the meaning ascribed to such term in Article 3.1.


 


“EXECUTION
DATE” means the date on which the last PARTY signs this AGREEMENT so as to make it signed by each of the PARTIES.


 


“FACILITIES”
means the facilities of FIOCRUZ in BIO-MANGUINHOS related to the PRODUCT, including the primary production facility, the secondary
facilities and the quality control laboratories to be adequated or built and validated, maintained and operated by FIOCRUZ, solely,
for each STAGE, after receipt by FIOCRUZ of written approval of PROTALIX following
a full inspection of such facility to ensure such facility is acceptable for the purpose contemplated hereunder for such STAGE.


 


“FIELD”
means enzyme replacement therapy for the treatment of Gaucher Disease for the approved indications, dosage forms and strengths.


 


“FILL/FINISH”
means (a) formulating the Product using Drug
Substance and required excipients, (b) filling the Product into vials, (c)
lyophilization of the Drug Substance for incorporation into the Product,
and (d) testing, including ongoing stability testing, and release of the  Product.
For the avoidance of doubt, Fill/Finish shall not include any activities included
in the definition of Labeling and Packaging.


“FINAL
PRODUCT” shall mean PRODUCT produced entirely by FIOCRUZ at the FACILITIES from the CELL BANK.


 


“FINISHED
PACKAGED PRODUCT” means the PRODUCT that has undergone FILL/FINISH and LABELING AND PACKAGING to be supplied by PROTALIX
to FIOCRUZ until the registration of PRODUCT 2 by ANVISA in PROTALIX's or FIOCRUZ's name.


 


“FORCE
MAJEURE EVENT” shall have the meaning ascribed to such term in Article 20.1.


 


“FORECAST”
shall have the meaning ascribed to such term in Article 6.2.1.


 


“GOOD
MANUFACTURING PRACTICES” or “GMP” means all applicable Good Manufacturing Practices including, (a) the
applicable part of quality assurance to ensure that products are consistently produced and controlled in accordance with the quality
standards appropriate for their intended use, as defined in ANVISA RDC 17 and RDC 66-07 laying down the principals and guidelines
of good manufacturing practice, (b) WHO GMP guidelines, and (c) the equivalent Laws
in any relevant country or other sovereign entity in which PRODUCT is marketed, manufactured, distributed, offered for sale, sold
or imported by or on behalf of FIOCRUZ, each as may be amended and applicable from time to time.


 


“GOVERNMENTAL
AUTHORITY” means any court, agency, department, authority or other instrumentality of any national, state, country, city
or other political subdivision.


 




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“GOVERNMENTAL
APPROVAL” means the authorizations and approvals (including regulatory and pricing approvals) of a Governmental
Authority that are necessary for the TECHNOLOGY TRANSFER, or the COMMERCIALIZATION, MANUFACTURE, use or exploitation of
the SUPPLIED MATERIALS, COMPOUND, DRUG SUBSTANCE or PRODUCTS in the TERRITORY.


 


“GOVERNMENT
OFFICIAL” shall have the meaning ascribed to such term in Article 17.2(f).


 


“IMPROVEMENT”
means any enhancements to the Protalix Technology enabling superior productivity,
therapeutic activity, feasibility, profitability and/or improvement of the production processes included in the Protalix
Technology.


 


“INDEMNIFIED
PARTY” shall have the meaning ascribed to such term in Article 16.3.


 


“INDEMNIFYING
PARTY” shall have the meaning ascribed to such term in Article 16.3.


 


"INITIAL
FORECAST" shall have the meaning ascribed to such term in Article 6.2.1.


 


“INPI”
means the Brazilian National Institute of Industrial Property.


 


“LABELING
AND PACKAGING” means the final product labeling and packaging of the Product
as intended for commercial distribution and sale of such PRODUCT to THIRD PARTIES in the TERRITORY, including insertion of materials
such as patient inserts, patient medication guides, professional inserts and any other written, printed or graphic materials accompanying
the Product.


 


“LAWS”
means all laws, statutes, rules, regulations, codes, administrative or judicial orders, judgments, decrees, injunctions and/or
ordinances of any Governmental Authority, and other legal requirements of any kind,
whether currently in existence or hereafter promulgated, enacted, adopted or amended.


 


“LOSSES”
means any and all damages (including all incidental, consequential, statutory and treble damages), awards, deficiencies, settlement
amounts, defaults, assessments, fines, dues, penalties, costs, fees (including reasonable attorney fees), liabilities, obligations,
taxes, liens, losses and expenses, including those incurred by or awarded to Third PARTIES
with respect to a Third PARTY Claim by reason of any judgment, order, decree,
stipulation or injunction, or any settlement entered into, and all other documented costs and expenses incurred in investigating,
preparing or defending any Third PARTY Claim
litigation or proceeding, commenced or threatened, or in complying with any judgments, orders, decrees, stipulations and
injunctions (including court costs, interest and reasonable fees of attorneys, accountants and other experts).


 


“MANUFACTURE”
or “MANUFACTURING” means all activities related to the manufacturing of the COMPOUND, Drug
Substance or ProductS, and/or any ingredient thereof, including manufacturing
for commercial sale, in-process and finished product testing, Fill/Finish, Labeling
and Packaging, release of product, quality assurance activities related to manufacturing and release of product and ongoing
stability tests and regulatory activities related to any of the foregoing.


 


“NAKED
VIALS” means unlabelled vials [***] of PRODUCT that have undergone FILL/FINISH.


 


“NET
SALES” means the gross receipts of all sales of FINAL PRODUCT by or on behalf of FIOCRUZ, less any sales taxes actually
incurred and paid by FIOCRUZ and reasonable out-of-pocket costs of transportation insurance and transportation for such FINAL
PRODUCT actually incurred and paid by FIOCRUZ. A Royalty Payment obligation shall accrue upon the receipt of payment for such
FINAL Product.


 




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[***]


 


"OCS"
means the Office of the Chief Scientist of the Israeli Ministry of Trade, Industry and Labor.


 


“ORAL
FORMULATION” means an oral formulation of a drug product for the treatment of Gaucher Disease which contains any Compound
as the active pharmaceutical ingredient.


 


“PATENT
APPLICATION” means any application for a Patent.


 


“PATENT
RIGHTS” means Patents and Patent
Applications.


 


“PATENTS”
means issued patents, whether domestic or foreign, including issued patents granted with respect to all continuations, continuations-in-part,
divisions, provisionals and renewals, patents of addition, supplementary protection certificates, registration or confirmation
patents and all reissues, re-examination and extensions thereof.


 


“PERMITS”
means all approvals, authorizations, stamps, registrations, clearances, consents, licenses, permits, certificates, or regulatory
approvals of any Governmental Authority.


 


“PERSON”
means an individual, corporation, partnership, company, joint venture, unincorporated organization, limited liability company
or partnership, sole proprietorship, association, bank, trust company or trust, whether or not legal entities, or any Governmental
Authority.


 


“PHARMACOVIGILANCE
AGREEMENT” means the PHARMACOVIGILANCE Agreement(s) set forth as Appendix VIII, between PROTALIX and FIOCRUZ.


 


“PRICE”
means the price to be charged by PROTALIX for SUPPLIED MATERIAL manufactured and supplied hereunder as delivered to FIOCRUZ, and
which price is set forth in Article 6, herein.


 


“PRODUCT”
means the pharmaceutical product plant cell expressed recombinant Glucocerebrosidase in any finished dosage form of a drug
product that contains Drug Substance (excluding any ORAL FORMULATION), which is
the object of the TECHNOLOGY TRANSFER under this AGREEMENT, and, as used in this AGREEMENT, refers to any one of PRODUCT 1, PRODUCT
2, PRODUCT 3 and FINAL PRODUCT (and PRODUCTS, as used in this AGREEMENT, refers to all of PRODUCT 1, PRODUCT 2, PRODUCT 3 and
FINAL PRODUCT).


 


“PRODUCT
1” shall mean the FINISHED PACKAGED PRODUCT supplied to FIOCRUZ by PROTALIX.


 


"PRODUCT
2" shall mean PRODUCT LABELED AND PACKAGED by FIOCRUZ at the FACILITIES from NAKED VIALS supplied to FIOCRUZ by PROTALIX.


 


“PRODUCT
3” shall mean PRODUCT FILLED/FINISHED and LABELED AND PACKAGED by FIOCRUZ at the FACILITIES from BULK PRODUCT supplied to
FIOCRUZ by PROTALIX.


 


“PRODUCT
MARKS” means the names and marks on the labeling and packaging of the FINISHED PACKAGED PRODUCTS supplied to FIOCRUZ hereunder
by PROTALIX.


 


“PROTALIX
PATENT RIGHTS” means all Patent Rights owned by PROTALIX or otherwise Controlled
by PROTALIX as of the EFFECTIVE DATE or at any time during the Term that
claim the composition of matter, MANUFACTURE or use of the Compound, Drug
Substance or a drug product that contains Drug Substance, including the
Patent Rights listed in Exhibit B.


 




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“PROTALIX
TECHNOLOGY” means any Technology possessed or otherwise Controlled
by PROTALIX as of the EFFECTIVE DATE or at any time during Term 1 that is
necessary for the MANUFACTURE of the PRODUCTS as MANUFACTURED by, on behalf of, or under license from, PROTALIX as of the EFFECTIVE
DATE.


 


“PURCHASE
ORDER” means a firm purchase order in written or electronic form submitted by FIOCRUZ in accordance with the terms of this
Agreement to PROTALIX authorizing the manufacture and supply of SUPPLIED MATERIAL.


 


“RATE”
shall have the meaning ascribed to such term in Article 9.4.


 


“RECIPIENT”
shall have the meaning ascribed to such term in Article 11.1.


 


“REPORTING
PERIOD” shall have the meaning ascribed to such term in Article 9.2.


 


“ROYALTY
PAYMENTS” shall have the meaning ascribed to such term in Article 9.1.


 


“SPECIFICATIONS”
means the specifications of the Drug Substance, PRODUCTS, and SUPPLIED MATERIALS
designated by PROTALIX, as initially set forth in Appendix I, which may be updated from time to time by PROTALIX, including with
respect to MANUFACTURING (including standard operating procedures for manufacturing), performance, quality control, release, and
fill/finish specifications.


 


“STAGES”
shall have the meaning ascribed to such term in Article 5.1.2.


 


“SUPPLIED
MATERIALS” means the FINISHED PACKAGED PRODUCT, Naked Vials, Bulk
Product and any other materials supplied to FIOCRUZ by PROTALIX for the MANUFACTURE and/or COMMERCIALIZATION by FIOCRUZ
of PRODUCTS in the TERRITORY for the FIELD in accordance with this AGREEMENT.


 


“TECHNOLOGY”
means all materials, technology, data, results and non-public technical, scientific and clinical information, in any tangible
or intangible form, including know-how, expertise, trade secrets, practices, techniques, methods, processes, developments, specifications,
formulations, formulae, and any intellectual property rights embodying any of the foregoing, but excluding any Patent
Rights.


 


“TECHNOLOGY
TRANSFER” means the provision to FIOCRUZ of the data and information comprising the Protalix
Technology and the non-exclusive, non-transferable rights to use the Protalix Technology
in the TERRITORY granted to FIOCRUZ hereunder), reasonably necessary to produce the PRODUCT, to be implemented in various
stages as described in Article 5.2 and Appendix II of this AGREEMENT, for the sole
purpose of enabling FIOCRUZ to MANUFACTURE the ProductS for sale within the Territory
for the FIELD, and all data and documentation in PROTALIX's possession or control reasonably necessary for FIOCRUZ to obtain
registration of the PRODUCTS by ANVISA, in accordance with and subject to the terms and conditions hereof.


 


“TERM”
shall mean "TERM 1" and "TERM 2", and such terms shall have the meanings ascribed to such terms in Articles
12.1 and 12.2, respectively.


 


“THIRD
PARTY” means any Person other than PROTALIX, FIOCRUZ or any of their respective
Affiliates.


 


“THIRD
PARTY CLAIM” shall have the meaning ascribed to such term in Article 16.3.


 




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“THIRD
PARTY LICENSE” means each license agreement between PROTALIX and a THIRD PARTY pursuant to which or from which PROTALIX
obtains a license to PROTALIX TECHNOLOGY or PROTALIX PATENT RIGHTS.


 


“TERRITORY”
means Brazil.


 


		1.2	Except
                                         where expressly stated otherwise in this AGREEMENT, the following rules of interpretation
                                         apply to this AGREEMENT: (a) “include”, “includes” and “including”
                                         are not limiting and mean include, includes and including, without limitation; (b) definitions
                                         contained in this AGREEMENT are applicable to the singular as well as the plural forms
                                         of such terms; (c) references to an agreement, statute or instrument mean such agreement,
                                         statute or instrument as from time to time amended, modified or supplemented; (d) references
                                         to a Person are also to its permitted
                                         successors and assigns; (e) references to an “Article”, “Section”,
                                         “Exhibit”, “Appendix” or “Schedule” refer to an Article
                                         or Section of, or any Exhibit, Appendix or Schedule to, this AGREEMENT unless otherwise
                                         indicated; (f) the word “will” shall be construed to have the same meaning
                                         and effect as the word “shall”; and (g) the word “any” shall
                                         mean “any and all” unless otherwise indicated by context. 



 


ARTICLE
2. AGREEMENT PURPOSE AND SCOPE


 


		2.1	The
                                         primary purpose and scope of this AGREEMENT is the TECHNOLOGY TRANSFER from PROTALIX
                                         to FIOCRUZ in order to enable FIOCRUZ to produce and supply PRODUCTS in the TERRITORY
                                         for the FIELD, as follows:



 


		(i)	during
                                         the TECHNOLOGY TRANSFER, the sale and supply exclusively by PROTALIX to FIOCRUZ of the
                                         SUPPLIED MATERIALS for the purpose of FIOCRUZ manufacturing PRODUCTS in accordance with
                                         the STAGES and the provisions of Articles 5 and 6 in such quantities as provided herein,
                                         in order to satisfy the requirements of the Brazilian MOH for plant cell expressed
                                         recombinant Glucocerebrosidase during the period of the TECHNOLOGY TRANSFER and until
                                         registration of the FINAL PRODUCT by ANVISA in FIOCRUZ's name. For the
                                         avoidance of doubt, subject to Section 4.8, sales by FIOCRUZ outside of Brazil will only
                                         apply to FINAL PRODUCT and shall only take place after full completion of the TECHNOLOGY
                                         TRANSFER and in accordance with the terms and conditions of this AGREEMENT;



 


		(ii)	the
                                         supply of all of the, documentation and technical information reasonably necessary for
                                         the manufacturing and releasing of the PRODUCTS;



 


		(iii)	a
                                         non-exclusive, non-transferable and non-sublicensable license of Protalix
                                         Patent Rights in the TERRITORY for the term of such PATENTS in the TERRITORY,
                                         subject to the terms and conditions of this AGREEMENT; and



 


		(iv)	the
                                         provision of TECHNICAL ASSISTANCE by PROTALIX to FIOCRUZ.



 




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ARTICLE
3. CONDITIONS PRECEDENT 


 


		3.1	This
                                         AGREEMENT shall become effective upon the last to occur of (a) the date of written notification
                                         by either PARTY to the other PARTY of approval by INPI of this AGREEMENT, (b) the date
                                         of written notification by either PARTY to the other PARTY of approval by OCS of this
                                         AGREEMENT, and (c) registration of the Product
                                         by ANVISA in the name of PROTALIX or, along with Laboratórios Pfizer Ltda.'s
                                         approval to import the PRODUCT into Brazil set forth on Appendix V, in the name of Laboratórios
                                         Pfizer Ltda. (the later of (a), (b) and (c), the “EFFECTIVE DATE”). If for
                                         any reason the supply of the FINISHED PACKAGED PRODUCT by PROTALIX to FIOCRUZ becomes
                                         prohibited under Brazilian LAW, notwithstanding anything to the contrary herein, PROTALIX
                                         shall not be required to supply such FINISHED PACKAGED PRODUCT for so long as such supply
                                         is prohibited and FIOCRUZ shall pay for any FINISHED PACKAGED PRODUCT already shipped
                                         to FIOCRUZ pursuant to the terms of this Agreement.



 


		3.2	FIOCRUZ
                                         shall, at its sole cost and expense, submit this AGREEMENT to the INPI for approval and
                                         recordation (and take all other actions reasonably necessary to obtain such approval
                                         and recordation) promptly following the EXECUTION DATE and shall promptly notify PROTALIX
                                         of the approval and recordation of this AGREEMENT by INPI. PROTALIX shall, at its sole
                                         cost and expense, submit this AGREEMENT to the OCS for approval (and take all other actions
                                         reasonably necessary to obtain such approval) promptly following the EXECUTION DATE and
                                         shall promptly notify FIOCRUZ of the approval of this AGREEMENT by OCS.



 


ARTICLE
4. GRANT OF RIGHTS


 


		4.1	Subject
                                         to the terms and conditions set forth herein, PROTALIX hereby grants to FIOCRUZ (a) the
                                         non-exclusive, non-transferable rights, as applicable, to use the Protalix
                                         Technology provided to FIOCRUZ hereunder, and (b) the non-exclusive, non-transferable
                                         and non-sublicensable license or sublicense, as applicable, under all PROTALIX PATENT
                                         RIGHTS in the TERRITORY for the duration of such Patent
                                         Rights, solely, with respect to the foregoing (a) and (b), for the purpose of
                                         MANUFACTURING PRODUCTS in the FACILITIES, and the COMMERCIALIZATION of such PRODUCTS,
                                         for sale within the Territory for the
                                         Field, as appropriate for each STAGE,
                                         in accordance with this AGREEMENT. Notwithstanding the foregoing, FIOCRUZ’s right
                                         to COMMERCIALIZE the PRODUCTS in the TERRITORY for the FIELD shall be exclusive; provided
                                         that (x) such right shall become non-exclusive in the event that FIOCRUZ fails to
                                         comply with this Article 4.1 or Article 7.2 or is unable to meet demand for the PRODUCTS
                                         in the TERRITORY, and (y) shall not be exclusive with respect to any Protalix
                                         PATENTS RIGHTS or Protalix Technology
                                         that is subject to a THIRD PARTY LICENSE that does not provide PROTALIX the rights
                                         to grant exclusive sublicenses thereof. Any sublicense obligations required by a THIRD
                                         PARTY LICENSE to be included in a sublicense shall be deemed to be included in this AGREEMENT
                                         as obligations of FIOCRUZ [***].



 


		4.2	FIOCRUZ
                                         shall not directly or indirectly market, promote, supply, distribute, offer for sale,
                                         or sell Products nor any other pharmaceutical
                                         product that contains DRUG SUBSTANCE or is derived from Protalix
                                         Technology or otherwise use or otherwise exploit the PROTALIX PATENTS RIGHTS,
                                         Protalix Technology, or SUPPLIED MATERIALS,
                                         in, for or to territories outside the TERRITORY or a field other than the Field,
                                         in connection with any other pharmaceutical products, or in any manner other than
                                         as expressly permitted hereunder.



 


		4.3	FIOCRUZ
                                         shall not, without the prior written consent of PROTALIX directly or indirectly (a) disclose
                                         or otherwise make available the Protalix Technology,
                                         nor assign, transfer, license, or sublicense any rights obtained by FIOCRUZ hereunder,
                                         to any AFFILIATE or THIRD PARTY, (b) use the Protalix
                                         Technology for research or development, (c) MANUFACTURE or COMMERCIALIZE ProductS
                                         in any facility or plant other than the Facilities
                                         or through any unit of FIOCRUZ other than BIO-MANGUINHOS, nor (d) other than for
                                         the PRODUCTS, use the PROTALIX PATENTS
                                         RIGHTS or Protalix Technology in connection
                                         with any pharmaceutical products (including any successor or alternative delivery, presentations
                                         or dosing regimens of the Product).



 




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		4.4	During
                                         the Term, FIOCRUZ shall not directly or
                                         indirectly market, promote, supply, distribute, offer for sale, sell or otherwise exploit
                                         any other products that, in PROTALIX’s good faith judgment may compete with the
                                         PRODUCT.



 


		4.5	During
                                         the Technology Transfer, PROTALIX shall
                                         make available to FIOCRUZ all Improvements CONTROLLED
                                         by such PARTY that are useful to the MANUFACTURE of the PRODUCTS.



 


		4.6	Except
                                         for the licenses and other rights granted to FIOCRUZ herein, all right, title and interest
                                         in and to the Protalix Patent Rights and
                                         Protalix Technology shall remain solely
                                         with PROTALIX and its licensors, as applicable.



 


		4.7	FIOCRUZ
                                         hereby covenants and agrees not to, directly or indirectly, commence (or assist any other
                                         Person in connection with) any claim,
                                         suit, action or other proceeding (including in front of any court or Governmental
                                         Authority, including any intellectual property office or registry), that challenges
                                         the legality, validity, enforceability, scope or ownership of any PROTALIX Patent
                                         Right or PROTALIX TECHNOLOGY (a “CHALLENGE”). If FIOCRUZ directly
                                         or indirectly commences (or assists any other Person
                                         in connection with) any Challenge,
                                         PROTALIX shall (a) have the right to immediately terminate this AGREEMENT by written
                                         notice effective upon receipt by FIOCRUZ, and (b) shall be entitled to recover from FIOCRUZ
                                         any and all costs and expenses, including reasonable attorneys’ fees and expenses
                                         of investigation and defense, incurred by PROTALIX in connection with such Challenge.



 


		4.8	Notwithstanding
                                         anything to the contrary herein, following COMPLETION of the TECHNOLOGY TRANSFER, [***].



 


		4.9	For
                                         the avoidance of doubt, notwithstanding the license granted hereunder, PROTALIX shall
                                         retain its exclusive right in the TERRITORY to partner with patient advocacy groups,
                                         and provide patient support and medical education services to health care professionals,
                                         during the TERM and thereafter until COMPLETION of the TECHNOLOGY TRANSFER or for so
                                         long as PROTALIX continues to supply PRODUCTS to the TERRITORY.



 


		4.10	From
                                         time to time throughout the TERM, PROTALIX will provide to FIOCRUZ information regarding
                                         the status of its development programs for the ORAL FORMULATION. Upon FIOCRUZ's reasonable
                                         request in writing (made no more than once per every twelve month period), PROTALIX agrees
                                         to discuss in good faith a possible collaboration with FIOCRUZ, or a license or sale
                                         to FIOCRUZ of rights, with respect to the ORAL FORMULATION. Any agreement resulting from
                                         such discussions relating to the ORAL FORMULATION (including any rights to be granted
                                         with respect to the ORAL FORMULATION) shall be separate and apart from this AGREEMENT.
                                         PROTALIX's obligations and FIOCRUZ's rights set forth in this Article 4.10 shall be PROTALIX's
                                         sole obligations and FIOCRUZ's sole rights hereunder with respect to the ORAL FORMULATION.



 


ARTICLE
5. TECHNOLOGY TRANSFER


 


5.1
General.  The TECHNOLOGY TRANSFER shall commence upon the EFFECTIVE DATE and shall be implemented as set forth in the
following chart (and as set forth in this Article 5 and Appendix II):


 




    	9



    	 



    

 


Estimated
Time Table of Milestones in Product Production and Supply, 

as a Result of Technology Transfer As Specified In Appendix II


 


	Stages	 	Supplied by

    PROTALIX for

    PRODUCT supply   	 	FIOCRUZ activity	 	Stages Quantity
	Stage
    0 –    Immediately after the EFFECTIVE DATE	 	 [***]
	 	 [***]
	 	

        [***]

	Stage
    1 –  Immediately after registration by ANVISA of PRODUCT 2 in FIOCRUZ's name	 	 

        [***]
	 	 

        [***]
	 	 

        [***]

	Stage
    2 - After validation of FIOCRUZ new FILL AND FINISH facility	 	 

        [***]
	 	 

        [***]
	 	 

        [***]

	Stage
    3 - After construction and validation of FIOCRUZ Plant Cell culturing facility and registration by ANVISA of FINAL PRODUCT
    in FIOCRUZ's name	 	 

        [***]
	 	 

        [***]
	 	 

        [***]

	TOTAL
    QUANTITY: [***] vials (or equivalent depending on PRODUCT type)	 	 


 


Note:
The FIOCRUZ activity set forth in each STAGE in the above chart (other than STAGE 0) shall only commence following the TECHNOLOGY
TRANSFER by PROTALIX for, and the COMPLETION of, the prior STAGE, as set forth in Appendix II (so that FIOCRUZ is able to properly
perform such activity). COMMERCIALIZATION of the FINAL PRODUCT shall only occur following COMPLETION of the TECHNOLOGY TRANSFER.
During each STAGE, as applicable, PROTALIX shall use commercially reasonable efforts to provide, at FIOCRUZ's cost, any proprietary
or non-commercial reagents and standards to FIOCRUZ that are required by FIOCRUZ in connection with its responsibilities for such
STAGE, and use commercially reasonable efforts to help FIOCRUZ to become self-sufficient to produce or obtain such materials or
reagents on its own.


 




    	10



    	 



    

 


		5.1.1	Subject
                                         to the terms and conditions hereof, PROTALIX shall make available to FIOCRUZ at and for
                                         the FACILITIES, on a STAGE by STAGE basis, all Protalix
                                         Technology that is necessary for such STAGE and for the related MANUFACTURING,
                                         quality control and registration by ANVISA of the PRODUCTS
                                         by FIOCRUZ (including or as reasonable necessary for obtaining requisite GOVERNMENTAL
                                         APPROVALS) in accordance with this AGREEMENT. All PROTALIX TECHNOLOGY shall be provided
                                         in the English language. FIOCRUZ may translate any such documents at its own risk, cost
                                         and expense. Notwithstanding anything to the contrary herein, PROTALIX will transfer
                                         the PROTALIX TECHNOLOGY relating to [***] as the last step of STAGE 3 of the TECHNOLOGY
                                         TRANSFER only following positive completion by FIOCRUZ of clinical trials for the FINAL
                                         PRODUCT and registration by ANVISA of the FINAL PRODUCT in FIOCRUZ's name (as well as
                                         the other steps of STAGE 3 [***].



 


		5.1.2	The
                                         PARTIES hereby agree that the TECHNOLOGY TRANSFER will be implemented in sequential stages
                                         (the “STAGES”) as set forth in Article 5.1, Article 5.2 and Appendix II.
                                         Each STAGE will take the time required to achieve the COMPLETION of such STAGE as provided
                                         by Article 5.2 and Appendix II. The beginning of each STAGE following STAGE 0 will be
                                         subject to the achievement of the COMPLETION REQUIREMENTS of the previous STAGE, as specified
                                         in Article 5.2 and Appendix II. FIOCRUZ will purchase the quantity of PRODUCTS set forth
                                         for each STAGE in the STAGES chart in Section 5.1, in order for COMPLETION of each such
                                         STAGE and commencement of the following STAGE (in addition to COMPLETING the other COMPLETION
                                         REQUIREMENTS), emphasizing that, notwithstanding anything to the contrary herein, proceeding
                                         to the STAGE 3 will only occur with the total purchase by FIOCRUZ of the estimated quantities
                                         for the STAGES 0, 1 and 2.



 


		5.1.3	PROTALIX
                                         and FIOCRUZ shall each appoint, no later than thirty (30) calendar days after the EXECUTION
                                         DATE, its respective Technical Project Managers (whose duties are set forth in Articles
                                         5.3 and 5.4 below) and prepare a coordination plan that will set forth and coordinate
                                         the activities of the PARTIES to take place during the period of the TECHNOLOGY TRANSFER.
                                         The coordination plan will take into account the contractual obligations of the PARTIES
                                         and shall include clauses such as addresses, correspondence, numbers, numbers of copies
                                         to be released, scheduling of activities, persons in charge, standards to be used for
                                         equipment and construction and other matters required or useful for the successful implementation
                                         of the TECHNOLOGY TRANSFER. Each of FIOCRUZ and PROTALIX shall notify the other in writing,
                                         at least thirty (30) days prior to replacing any of its Technical Project Managers and,
                                         in such case, shall cause both the replaced Technical Project Manager and the replacement
                                         Technical Project Manager to work together during a transition term of at least thirty
                                         (30) days.



 


		5.1.4	During
                                         all STAGES, FIOCRUZ shall, at its own cost and expense, be responsible for (a) obtaining
                                         all GOVERNMENTAL APPROVALS required to MANUFACTURE and COMMERCIALIZE the PRODUCTS MANUFACTURED
                                         in the FACILITY in the Territory in accordance
                                         with the applicable STAGE, and (b) the construction, validation, maintenance and operation
                                         of the FACILITIES (including the new lyophilization suite, bioreactor facility and purification
                                         suites). FIOCRUZ shall be permitted to conduct any clinical trials approved by ANVISA
                                         required to obtain GOVERNMENTAL APPROVALS in the TERRITORY for the PRODUCTS entirely
                                         MANUFACTURED by FIOCRUZ at the FACILITY for the FIELD; provided FIOCRUZ provides
                                         PROTALIX prior written notice thereof and reasonably consults with PROTALIX upon PROTALIX’s
                                         request.



 




    	11



    	 



    

 


		5.1.5	Notwithstanding
                                         Article 5.1.4, and for the avoidance of doubt, (a) FIOCRUZ acknowledges and agrees that
                                         PROTALIX shall be permitted to obtain and maintain, and take all actions necessary to
                                         obtain and maintain its own GOVERNMENTAL APPROVALS for the PRODUCTS or similar pharmaceutical
                                         products in the TERRITORY, and (b) the PARTIES acknowledge and agree that until FIOCRUZ
                                         obtains its own GOVERNMENTAL APPROVAL for the ProductS,
                                         FIOCRUZ shall COMMERCIALIZE the FINISHED PACKAGED PRODUCT supplied by PROTALIX under
                                         the GOVERNMENTAL APPROVALS obtained prior to the Effective
                                         Date by PROTALIX for the Territory.



 


		5.1.6	The
                                         purchase by and supply to FIOCRUZ of SUPPLIED MATERIALS during each STAGE of TECHNOLOGY
                                         TRANSFER shall occur in accordance with Article 6. As part of the TECHNOLOGY TRANSFER,
                                         PROTALIX may supply specific SUPPLIED MATERIALS to FIOCRUZ for the sole purpose of testing,
                                         validation and training, and for preparation for the following STAGE. FIOCRUZ shall utilize
                                         such SUPPLIED MATERIALS solely for such purpose and not for any commercial use.



 


		5.2	STAGEs.
                                         The TECHNOLOGY TRANSFER will be implemented in the sequential STAGES set forth in Appendix
                                         II, subject to and in accordance with the terms hereof, including Appendix II.



 


		5.3	Responsibilities
                                         of PROTALIX. The sole obligations of PROTALIX relating to the TECHNOLOGY TRANSFER
                                         are set forth in this Article 5 and FIOCRUZ agrees that PROTALIX shall have no other
                                         obligations, express or implied, with respect thereto.



 


		5.3.1	The
                                         PROTALIX Project Technical Manager will represent PROTALIX with respect to the implementation
                                         of the TECHNOLOGY TRANSFER. The PROTALIX Project Technical Manager will coordinate all
                                         activities of PROTALIX in relation to the TECHNOLOGY TRANSFER in cooperation with the
                                         FIOCRUZ Project Technical Manager. The PROTALIX Project Technical Manager shall not be
                                         responsible for the responsibilities of FIOCRUZ nor for management of FIOCRUZ’s
                                         employees or other personnel.



 


		5.3.2	Following
                                         [***], in the event that FIOCRUZ's CELL BANK is damaged or otherwise becomes defective,
                                         PROTALIX shall utilize its own CELL BANK to provide a new CELL BANK to FIOCRUZ.



 


		5.3.3	All
                                         of PROTALIX’s obligations under this Article 5 shall (a) be conditioned on FIOCRUZ’s
                                         cooperation in connection therewith and compliance with this AGREEMENT (including fulfillment
                                         of its responsibilities set forth in this Article 5), and (b) cease upon Completion
                                         of the final STAGE of the TECHNOLOGY TRANSFER.



 


		5.4	Responsibilities
                                         of FIOCRUZ



 


		5.4.1	The
                                         FIOCRUZ Project Technical Manager will represent FIOCRUZ with respect to the implementation
                                         of the TECHNOLOGY TRANSFER. The FIOCRUZ Project Technical Manager of FIOCRUZ will coordinate
                                         all activities of FIOCRUZ in relation to the TECHNOLOGY TRANSFER in cooperation with
                                         the PROTALIX Project Technical Manager. The FIOCRUZ Project Technical Manager shall not
                                         be responsible for the responsibilities of PROTALIX nor for management of PROTALIX’s
                                         employees or other personnel.



 




    	12



    	 



    

 


		5.4.2	[***]
                                         in the event that PROTALIX's CELL BANK is damaged or otherwise becomes defective, FIOCRUZ
                                         shall utilize its own CELL BANK to provide a new CELL BANK to PROTALIX.



 


		5.4.3	FIOCRUZ
                                         shall take all necessary steps to ensure the FACILITY is constructed, maintained and
                                         operated in a manner that enables the safe and proper use of the PROTALIX TECHNOLOGY
                                         solely for the MANUFACTURE of the PRODUCTS in accordance with this AGREEMENT. FIOCRUZ
                                         will be responsible for the construction, validation, maintenance and operation of the
                                         FACILITIES during the term of this AGREEMENT and those FACILITIES shall at all times
                                         be (a) approved by ANVISA, (b) appropriate and adequate for implementing the then-current
                                         STAGE, and (c) in compliance with all the applicable LAWS, SPECIFICATIONS and GMP. The
                                         MANUFACTURING, COMMERCIALIZATION and storage operations, procedures and processes used
                                         by FIOCRUZ in connection with the MANUFACTURE of PRODUCTS hereunder (including any FACILITY)
                                         shall be in full compliance with all applicable SPECIFICATIONS and LAWS, including GMP
                                         and health and safety LAWS.



 


		5.4.4	All
                                         costs and expenses related to the FACILITIES, including their construction, operation,
                                         maintenance and validation, shall be borne by FIOCRUZ. FIOCRUZ shall staff the FACILITIES
                                         with qualified personnel to perform all STAGES of the production and operation process
                                         and obtain the required GOVERNMENTAL APPROVALS therefor.



 


		5.4.5	Except
                                         as otherwise expressly set forth herein, FIOCRUZ shall be responsible for the production
                                         and acquisition, at its own cost and expense, of all necessary materials. FIOCRUZ shall
                                         be responsible for the ensuring the quality of all such materials, including that such
                                         materials meet all requirements of applicable Brazilian LAWS.



 


		5.5	ADVISORY
                                         COMMITTEE. PROTALIX and FIOCRUZ shall establish an ADVISORY COMMITTEE as of the EFFECTIVE
                                         DATE composed of three (3) senior members of each of PROTALIX and FIOCRUZ. The members
                                         of the ADVISORY COMMITTEE may be represented at any meeting by a designee appointed by
                                         such member for such meeting. The chairperson of the ADVISORY COMMITTEE shall be designated
                                         by PROTALIX. FIOCRUZ shall designate one of its representative members as secretary to
                                         the ADVISORY COMMITTEE. Each such PARTY shall be free to change its representative members
                                         by notice to the other such PARTY.



 


		5.5.1	Responsibilities.
                                         The ADVISORY COMMITTEE shall be responsible for advising on and monitoring the implementation
                                         of the TECHNOLOGY TRANSFER, including clinical development work and regulatory activities
                                         in relation to PRODUCTS in a manner which is consistent with the terms and conditions
                                         of this AGREEMENT.



 




    	13



    	 



    

 


		5.5.2	Meetings.
                                         The ADVISORY COMMITTEE shall meet at least twice every calendar year, (and more frequently
                                         should PROTALIX and FIOCRUZ agree to such more frequent meetings), on such dates and
                                         at such times as PROTALIX and FIOCRUZ shall agree. Additional meetings may also be called
                                         by either PROTALIX or FIOCRUZ as reasonably required, on forty (40) calendar days written
                                         notice to the other, unless such notice is waived by such other PARTY. The meetings shall
                                         alternate between the offices of PROTALIX and FIOCRUZ, unless the PARTIES otherwise agree.
                                         The chairperson shall be responsible for sending notices of meetings to all members.
                                         The ADVISORY COMMITTEE may also convene or be polled or consulted from time to time by
                                         means of telecommunications, video conferences or correspondence, as deemed necessary
                                         or appropriate. Fifteen (15) calendar days prior to each ADVISORY COMMITTEE meetings
                                         described above, an English summary of progress under the TECHNOLOGY TRANSFER shall be
                                         provided by FIOCRUZ to the members of the ADVISORY COMMITTEE, including detailed accounting
                                         of the expenditures.



 


		5.5.3	Decisions.
                                         All decisions of the ADVISORY COMMITTEE shall be made by unanimous consent of the members
                                         present in person or by telephone or teleconferences/videoconferences at any meeting,
                                         with FIOCRUZ members cumulatively having one (1) vote and PROTALIX members cumulatively
                                         having one (1) vote. A quorum for a meeting shall require at least one (1) representative
                                         from FIOCRUZ and at least one (1) representative from PROTALIX.



 


		5.5.4	In
                                         the event that unanimity cannot be reached by the ADVISORY COMMITTEE with respect to
                                         a matter that is subject to its decision-making authority, then the matter shall be referred
                                         for further review and resolution to the President of PROTALIX or such other similar
                                         position designated by PROTALIX from time to time, and the President of FIOCRUZ, or such
                                         other similar position designated by FIOCRUZ from time to time. The designated persons
                                         at each of PROTALIX and FIOCRUZ shall use reasonable efforts to resolve the matter within
                                         thirty (30) days after the matter is referred to them. In the event that the designated
                                         officers fail to resolve the matter during such time period, PROTALIX and FIOCRUZ agree
                                         to submit the matter to be resolved with the assistance of a suitably qualified independent
                                         mediator or expert. In the event that the matter is still not resolved within fifty (50)
                                         days after the matter was referred to the designated persons at each of PROTALIX and
                                         FIOCRUZ the proposal or determination of PROTALIX’s President shall prevail (provided
                                         such proposal or determination shall be made in good faith).



 


		5.5.5	Minutes.
                                         Within fifteen (15) BUSINESS DAYS after each ADVISORY COMMITTEE meeting, the secretary
                                         of the ADVISORY COMMITTEE shall prepare and distribute minutes of the meeting, which
                                         shall provide a description in reasonable detail of the discussions held at that meeting
                                         and a list of any actions, decisions and/or determinations approved by the ADVISORY COMMITTEE.
                                         The secretary shall be responsible for circulation of all drafts and final minutes. Draft
                                         minutes shall be first circulated to the chairperson, edited and approved by the chairperson
                                         and then circulated in final draft form to all members of the ADVISORY COMMITTEE sufficiently
                                         in advance of the next meeting to allow adequate review and comment prior to the meeting.
                                         Minutes shall be approved or disapproved, and revised as necessary, at the next meeting.
                                         Final minutes shall be distributed to the members of the ADVISORY COMMITTEE.



 


		5.5.6	Expenses.
                                         Each PARTY shall be responsible for all travel and related costs for its representatives
                                         to attend meetings of, and otherwise participate on, the ADVISORY COMMITTEE.



 




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		5.5.7	During
                                         the term of this AGREEMENT, the ADVISORY COMMITTEE shall be assisted by specific task
                                         forces (“TASK FORCES”) which shall be responsible for advising the ADVISORY
                                         COMMITTEE within their area of responsibilities and implementing the decisions made by
                                         the ADVISORY COMMITTEE to the extent such decisions are within the competence of the
                                         TASK FORCES. The following TASK FORCES shall be organized:



 


		(i)	a
                                         technical TASK FORCE;



 


		(ii)	a
                                         clinical and regulatory TASK FORCE;



 


		(iii)	a
                                         manufacturing TASK FORCE; and



 


		(iv)	other
                                         TASK FORCES may be established upon the decision of the ADVISORY COMMITTEE.



 


The
composition and numbers of representatives of each PARTY on each TASK FORCE shall be decided by both PROTALIX and FIOCRUZ on an
ad hoc basis. Each of PROTALIX and FIOCRUZ shall be responsible for all travel and related costs for its representatives to attend
TASK FORCE meetings.


 


ARTICLE
6. PURCHASE AND SUPPLY OF SUPPLIED MATERIALS


 


		6.1	Agreement
                                         to Supply.



 


		6.1.1	Commencing
                                         on the EFFECTIVE DATE and continuing until the COMPLETION of the TECHNOLOGY TRANSFER,
                                         PROTALIX will supply and FIOCRUZ will purchase SUPPLIED MATERIALS, in the form (e.g.,
                                         FINISHED PACKAGED PRODUCT, NAKED VIALS, BULK PRODUCT, etc.) appropriate for the then-current
                                         STAGE, that are necessary for FIOCRUZ to MANUFACTURE and/or COMMERCIALIZE the PRODUCTS
                                         in the TERRITORY for the FIELD, at the pricing set forth herein. [***]



 


		6.1.2	Commercial
                                         supply will commence as soon as commercially reasonable, following the receipt of ANVISA
                                         approval for the PRODUCT.



 


		6.1.3	Commencing
                                         on the EFFECTIVE DATE and continuing until the later of COMPLETION of the TECHNOLOGY
                                         TRANSFER, FIOCRUZ shall purchase the SUPPLIED MATERIALS from PROTALIX on an exclusive
                                         basis.



 


		6.1.4	During
                                         the TECHNOLOGY TRANSFER, if FIOCRUZ is unable to MANUFACTURE the PRODUCTS in accordance
                                         with the then-current STAGE, then FIOCRUZ shall, in accordance with this Article 6, submit
                                         to PROTALIX orders for, and PROTALIX shall use commercially reasonable efforts to fulfill
                                         such orders for, SUPPLIED MATERIALS in the form required by FIOCRUZ to MANUFACTURE and/or
                                         COMMERCIALIZE the PRODUCTS (e.g., if, during STAGE 3, FIOCRUZ cannot adequately
                                         FILL/FINISH the BULK PRODUCT to create PRODUCTS, then PROTALIX shall use commercially
                                         reasonable efforts to supply [***] ordered by FIOCRUZ); provided that FIOCRUZ
                                         provides PROTALIX sixty (60) days advance notice thereof.



 


		6.1.5	FINISHED
                                         PACKAGED PRODUCT will be provided with a minimum [***] remaining shelf life and NAKED
                                         VIALS will be provided with a minimum [***] remaining shelf life.



 




    	15



    	 



    

 


		6.2	Forecasts
                                         and Purchase Orders.



 


		6.2.1	On
                                         the EFFECTIVE DATE, or such later date that is at least ninety (90) days preceding the
                                         first requested delivery date for SUPPLIED MATERIALS, FIOCRUZ shall deliver to PROTALIX,
                                         FIOCRUZ’s quarterly projection of the quantities of SUPPLIED MATERIALS that FIOCRUZ
                                         anticipates ordering from PROTALIX for the four (4) calendar quarters commencing with
                                         the first quarter that includes the first requested delivery date (the “INITIAL
                                         FORECAST”), together with a Purchase Order for SUPPLIED MATERIALS for the first
                                         two (2) calendar quarters covered by such Initial Forecast. The quantities of SUPPLIED
                                         MATERIALS specified for the remaining quarters of such Initial Forecast shall be non-binding.
                                         Thereafter, ninety (90) days prior to the first business day of each subsequent calendar
                                         quarter during the Term, FIOCRUZ shall deliver to PROTALIX a rolling four (4) calendar
                                         quarter forecast updating the prior forecast (together with the Initial Forecast, each
                                         a “FORECAST”), together with a Purchase Order for the first two (2) calendar
                                         quarters of such Forecast. The quantities of SUPPLIED MATERIALS specified for the remaining
                                         two (2) quarters of such Forecast shall be non-binding. Unless agreed separately between
                                         the PARTIES, each Purchase Order shall specify no more than three (3) delivery dates
                                         for the SUPPLIED MATERIALS in each calendar quarter. Purchase Orders shall be in writing,
                                         and no verbal communications or e-mail shall be construed to mean a commitment to purchase
                                         or sell. PROTALIX shall confirm receipt of any valid Purchase Order as soon as reasonably
                                         practicable after receipt. Subject to Sections 6.2.2, PROTALIX shall provide SUPPLIED
                                         MATERIALS to FIOCRUZ pursuant to valid Purchase Orders issued by FIOCRUZ to PROTALIX.
                                         FIOCRUZ shall provide PROTALIX with a written acknowledgment of receipt of SUPPLIED MATERIALS
                                         within three (3) BUSINESS DAYS of its receipt of SUPPLIED MATERIALS. This written acknowledgment
                                         shall confirm the quantity of SUPPLIED MATERIALS delivered and the date of delivery.



 


		6.2.2	Unless
                                         otherwise agreed in writing by PROTALIX, in no event shall PROTALIX be obligated to deliver
                                         quantities of SUPPLIED MATERIALS specified in a Purchase Order for a quarter which exceed
                                         [***] of the quantities specified by FIOCRUZ for the same period in the Forecast delivered
                                         in the prior calendar quarter. PROTALIX shall, however, use commercially reasonable efforts,
                                         but will be under no obligation, to supply SUPPLIED MATERIALS in excess of [***] of such
                                         quantities specified in such Forecast. Without limitation to the foregoing, in no event
                                         shall PROTALIX be required to supply quantities of SUPPLIED MATERIALS in excess of those
                                         commercially reasonable for PROTALIX to supply for any given period.



 


		6.2.3	Subject
                                         to Section 6.2.2, FIOCRUZ shall purchase all SUPPLIED MATERIALS ordered and specified
                                         in a Purchase Order. Purchase Orders may be delivered electronically or by other means
                                         to such location and in such manner as the PARTIES shall agree All Purchase Orders, confirmations
                                         of receipt of Purchase Orders and other notices contemplated under this Section 6.2 shall
                                         be sent to the attention of such persons as each party may identify to the other in writing
                                         from time to time in accordance with Section 20.9.



 


		6.2.4	The
                                         Forecasts shall show demand for SUPPLIED MATERIALS on a monthly basis, and for the first
                                         three months of any such Forecast shall state the dates of required delivery for such
                                         SUPPLIED MATERIAL.



 






    	16



    	 



    

 


		6.2.5	All
                                         Forecasts and Purchase Orders shall set forth the presentation of such SUPPLIED MATERIALS
                                         (e.g., FINISHED PACKAGED PRODUCT, NAKED VIALS, BULK PRODUCT).



 


		6.2.6	FIOCRUZ
                                         shall not submit Purchase Orders for, and PROTALIX shall not be required to supply, any
                                         single delivery of SUPPLIED MATERIALS of less than [***] of SUPPLIED MATERIALS (or the
                                         equivalent thereof with respect to DRUG SUBSTANCE). For the avoidance of doubt, all vials
                                         supplied hereunder shall be [***].



 


		6.2.7	PROTALIX
                                         shall use commercially reasonable efforts to meet FIOCRUZ requests for additional quantities
                                         beyond those set forth in Purchase Orders.



 


		6.3	Delivery;
                                         Risk of Loss.



 


		6.3.1	PROTALIX
                                         shall ship SUPPLIED MATERIALS ordered by FIOCRUZ as set forth in the applicable Purchase
                                         Order, in accordance with the terms hereof. PROTALIX shall deliver SUPPLIED MATERIALS
                                         to FIOCRUZ by the delivery date set forth in the applicable Purchase Order, or such other
                                         date as may be agreed to in writing by the PARTIES from time to time. PROTALIX shall
                                         deliver SUPPLIED MATERIALS to FIOCRUZ FCA Protalix airport, customs cleared at shipping
                                         point, as per Incoterms 2000.



 


		6.3.2	PROTALIX
                                         shall include certificates of analysis with all shipments of SUPPLIED MATERIAL.



 


		6.3.3	Title
                                         to SUPPLIED MATERIAL shall pass to FIOCRUZ when the SUPPLIED MATERIAL has been delivered
                                         to FIOCRUZ pursuant to Article 6.3.1 above.



 


		6.3.4	FIOCRUZ
                                         is responsible for acquiring import permits, letters of credit, customs clearance in
                                         Brazil and local transportation and distribution necessary for the supply and receipt
                                         of SUPPLIED MATERIALS to be supplied to FIOCRUZ hereunder.



 


		6.4	Price;
                                         Payment; Taxes.



 


		6.4.1	In
                                         the event the TECHNOLOGY TRANSFER is not COMPLETED by the end of the initial seven (7)
                                         year period, FIOCRUZ shall continue to obtain from PROTALIX its requirements of PROTALIX
                                         BULK PRODUCT for production of the PRODUCT at the same terms and conditions as described
                                         above and, for the renewal periods in TERM 1, PROTALIX shall provide [***]% discount
                                         over the last price of BULK PRODUCT as described in table below (6.4.2).



 


		6.4.2	During
                                         TERM 1, the pricing for the SUPPLIED MATERIALS shall be as follows:



 




    	17



    	 



    

 


	Year	 	FINISHED PACKAGED

    PRODUCT PRICE [***]	 	NAKED VIALS

    PRICE [***]	 	BULK

    PRODUCT

    PRICE [***]
	From
    the EFFECTIVE DATE until one (1) year after the EFFECTIVE DATE.	 	

    [***]	 	

    [***]	 	

    [***]
	From
    the end of the foregoing period until two (2) years after the EFFECTIVE DATE.	 	

    [***]	 	

    [***]	 	

    [***]
	From
    the end of the foregoing period until three (3) years after the EFFECTIVE DATE.	 	

    [***]	 	

    [***]	 	

    [***]
	From
    the end of the foregoing period until four (4) years after the EFFECTIVE DATE.	 	

    [***]	 	

    [***]	 	

    [***]
	From
    the end of the foregoing period until five (5) years after the EFFECTIVE DATE.	 	

    [***]	 	

    [***]	 	

    [***]
	From
    the end of the foregoing period until six (6) years after the EFFECTIVE DATE.	 	

    [***]	 	

    [***]	 	

    [***]
	From
    the end of the foregoing period until the COMPLETION of the TECHNOLOGY TRANSFER	 	

    [***]	 	

    [***]	 	

    [***]


 


		6.4.3	Invoices
                                         and Payment. PROTALIX shall submit invoices to FIOCRUZ upon shipment of SUPPLIED
                                         MATERIALS to the address in the TERRITORY set forth in the applicable Purchase Order.
                                         FIOCRUZ shall pay all amounts due in U.S. Dollars within [***] from the date of receipt
                                         of the invoice by FIOCRUZ.



 


		6.4.4	Taxes.
                                         Subject to Article 9.5 of this Agreement:



 


		I.	the
                                         Price includes all taxes except such sales, value-added and use taxes which PROTALIX
                                         is required by law to collect from FIOCRUZ;



 


		II.	such
                                         taxes, if any, will be separately stated in PROTALIX's invoice and will be paid by FIOCRUZ
                                         to PROTALIX, unless FIOCRUZ provides an exemption to PROTALIX, and subject to receipt
                                         of a valid receipt or invoice to FIOCRUZ in the form and manner required by LAW to allow
                                         FIOCRUZ to recover such taxes to the extent allowable by LAW; and



 


		III.	PROTALIX
                                         shall be solely responsible for the timely payment of all such taxes to the applicable
                                         GOVERNMENTAL AUTHORITY.



 




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		6.5	Purchase
                                         Order Effective Upon Anvisa Approval; Letter of Credit.



 


		6.5.1	Notwithstanding
                                         anything to the contrary herein, (i) the PURCHASE ORDER set forth in Appendix IV for
                                         the first delivery, for [***], of PRODUCT for STAGE 0 of the Agreement shall be deemed
                                         to be delivered by FIOCRUZ to PROTALIX concurrently upon the EFFECTIVE DATE, and (ii)
                                         the PURCHASE ORDER for [***] of PRODUCT for completion of STAGE 0 of the AGREEMENT, shall
                                         be deemed to be delivered by FIOCRUZ to PROTALIX [***]. As security for payment of the
                                         PRICE for the PRODUCT to be ordered pursuant to such PURCHASER ORDER for the first delivery
                                         of STAGE 0, concurrently with the execution and delivery of this Agreement, FIOCRUZ shall
                                         execute and deliver to PROTALIX the letter of credit attached hereto as Appendix VI. 
                                         For the avoidance of doubt, the quantity of PRODUCT purchased pursuant to such PURCHASE
                                         ORDER shall count towards and satisfy the first delivery requirement for STAGE 0 set
                                         forth in Section 5.1. As security for payment of the PRICE for the PRODUCT to be ordered
                                         pursuant to PURCHASE ORDERS, (a) concurrently with the execution and delivery of this
                                         AGREEMENT, FIOCRUZ shall request an irrevocable letter of credit to be confirmed by a
                                         first class USA bank covering the PURCHASE ORDER for the first delivery of STAGE 0 of
                                         this AGREEMENT, in the form of the request attached hereto as Appendix VI, (b) within
                                         thirty (30) days of the execution and delivery of this AGREEMENT, FIOCRUZ shall provide
                                         to PROTALIX a fully executed and effective irrevocable letter of credit confirmed by
                                         a first class USA bank covering the PURCHASE ORDER for the first delivery of STAGE 0
                                         of this AGREEMENT, in a form reasonably acceptable to PROTALIX, and (c) on or prior to
                                         submission of each subsequent PURCHASE ORDER [***] FIOCRUZ shall execute and deliver
                                         other irrevocable letters of credit confirmed by a first class USA bank covering the
                                         PURCHASE ORDER for such delivery under the AGREEMENT (in the same form as the letter
                                         of credit provided by FIOCRUZ for the first delivery of STAGE 0 of this AGREEMENT), together
                                         covering the total amount of the AGREEMENT, along the duration of the AGREEMENT. 
                                         [***]  Notwithstanding anything to the contrary herein, PROTALIX shall have no obligation
                                         to ship any PRODUCT for any year of this AGREEMENT until a fully executed and effective
                                         letter of credit for such PURCHASE ORDER of the AGREEMENT (that complies with the terms
                                         of this Section 6.5.1) is delivered to PROTALIX.



 


		6.5.2	In
                                         the event that COMPLETION of the TECHNOLOGY TRANSFER is not achieved prior to the date
                                         occurring seven (7) years following the EFFECTIVE DATE, this AGREEMENT may be renewed,
                                         pursuant to and in accordance with Section 12.1; provided that, for each such
                                         renewal period, PURCHASE ORDERS and a letter of credit equivalent to those provided for
                                         in Section 6.5.1 are executed by FIOCRUZ and delivered to PROTALIX prior to such renewal



 


ARTICLE
7. MANUFACTURE; COMMERCIALIZATION AND QUALITY CONTROL


 


		7.1	Manufacture



 


		7.1.1	During
                                         the TERM following the EFFECTIVE DATE, FIOCRUZ shall perform the applicable MANUFACTURING
                                         steps with respect to the PRODUCTS solely in the FACILITY and solely from the SUPPLIED
                                         MATERIALS supplied by PROTALIX to FIOCRUZ.



 




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		7.1.2	FIOCRUZ
                                         shall employ only the MANUFACTURING and other processes, and shall comply with the quality
                                         control standards, included in the PROTALIX TECHNOLOGY provided to FIOCRUZ and shall
                                         ensure that the PRODUCTS complies with the SPECIFICATIONS, GMP standards and all applicable
                                         Brazilian LAWS. There shall be no changes made to such processes, standards, or SPECIFICATIONS
                                         without PROTALIX’s prior written consent.



 


		7.1.3	FIOCRUZ
                                         represents and warrants that the FACILITIES and FIOCRUZ’s MANUFACTURING practices
                                         at the FACILITIES shall at all times comply with all applicable Brazilian LAWS, SPECIFICATIONS
                                         and GMP standards.



 


		7.1.4	FIOCRUZ
                                         shall use the PROTALIX TECHNOLOGY and SPECIFICATIONS (including any items provided pursuant
                                         to the TECHNOLOGY TRANSFER, such as the bioreactors, growth media, and cell banks) solely
                                         for the purposes of MANUFACTURING the PRODUCTS in the FACILITY, pursuant to and in accordance
                                         with this AGREEMENT, and not in connection with any other pharmaceutical products unless
                                         agreed to by the PARTIES in writing in advance.



 


		7.1.5	PROTALIX
                                         may, in its sole discretion, modify the SPECIFICATIONS upon written notice to FIOCRUZ.
                                         PROTALIX shall use commercially reasonable efforts to provide written justification of
                                         such changes (which shall include information and data supporting such change) to FIOCRUZ
                                         in a reasonably prompt manner so that FIOCRUZ may update the PRODUCT registration in
                                         ANVISA held by FIOCRUZ.



 


		7.2	Commercialization



 


		7.2.1	FIOCRUZ
                                         shall use its best efforts to diligently COMMERCIALIZE the PRODUCTS in accordance with
                                         this AGREEMENT.



 


		7.2.2	FIOCRUZ
                                         represents and warrants that FIOCRUZ’s COMMERCIALIZATION shall at all times comply
                                         with all applicable Brazilian LAWS and the highest commercial and ethical standards.



 


		7.2.3	FIOCRUZ’s
                                         COMMERCIALIZATION, including with respect to the marketing and promotion, of the PRODUCTS
                                         shall only be for the approved indications, dosage forms and strengths included in the
                                         FIELD.



 


		7.3	Access
                                         to the Facilities and Technical Visits;
                                         Payment for Technical Assistance.



 


		7.3.1	During
                                         the TECHNOLOGY TRANSFER, PROTALIX shall have the right to enter the FACILITIES, during
                                         normal business hours to check and verify the FACILITY, DRUG SUBSTANCES, PRODUCTS, SUPPLIED
                                         MATERIALS and any MANUFACTURING processes, quality control standards and other activities
                                         relating to the foregoing or this AGREEMENT that are performed at the FACILITY to ensure
                                         compliance with this AGREEMENT (including compliance with the SPECIFICATIONS, GMP standards,
                                         and applicable Brazilian LAW and achievement of COMPLETION REQUIREMENTS). FIOCRUZ shall
                                         implement any mitigation plan reasonably identified by PROTALIX to address any such findings.



 






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		7.3.2	FIOCRUZ
                                         shall allow PROTALIX and/or its representatives/designees reasonable access to the FACILITIES
                                         and to its records in order to enable PROTALIX to conduct periodic reviews during normal
                                         business hours of the health and safety practices and performance of the FACILITIES.
                                         In connection with such audit or evaluation, FIOCRUZ shall cooperate in the completion
                                         of a Health & Safety survey by PROTALIX or in the scheduling of a Health & Safety
                                         audit of any FACILITY, as applicable. FIOCRUZ shall correct, at its own cost and expense,
                                         any material deficiencies in its health and safety management practices that are identified
                                         to it. FIOCRUZ acknowledges that such reviews and evaluations conducted by PROTALIX are
                                         for the benefit of PROTALIX only and are not a substitute for FIOCRUZ’s own health
                                         and safety management obligations under this AGREEMENT and, accordingly, FIOCRUZ may
                                         not rely upon them.



 


		7.4	Quality
                                         Control Testing/Validation.



 


		7.4.1	For
                                         each STAGE of the TECHNOLOGY TRANSFER, FIOCRUZ shall be responsible for validation of
                                         the MANUFACTURING and operating processes and quality control testing as conducted by
                                         FIOCRUZ at the FACILITIES. During the TECHNOLOGY TRANSFER, upon PROTALIX’s request,
                                         FIOCRUZ shall, at FIOCRUZ’s sole cost and expense, (a) submit a sample of any production
                                         batch of the PRODUCTS for parallel quality control testing to be performed by PROTALIX
                                         or representatives/designees, (b) make available to PROTALIX any books and records relating
                                         to the MANUFACTURING and operating processes, quality control testing, DRUG SUBSTANCE,
                                         SUPPLIED MATERIALS and the PRODUCTS, and (c) provide to PROTALIX all documentation reasonably
                                         necessary to evidence that the PROTALIX TECHNOLOGY and SUPPLIED MATERIALS have been used
                                         only in accordance with this AGREEMENT.



 


		7.4.2	During
                                         the TERM of the AGREEMENT, in accordance with Section 7.4.1(a), FIOCRUZ will supply with
                                         each sample supplied to PROTALIX, a certificate of analysis duly signed by an individual
                                         qualified and authorized with respect to the PRODUCTS in sufficient detail to demonstrate
                                         conformity with the SPECIFICATIONS. If any delivery consists of the PRODUCTS of more
                                         than one production batch, FIOCRUZ shall provide a certificate of analysis for each such
                                         batch.



 


		7.4.3	In
                                         the event that the results of the quality control tests of PROTALIX and FIOCRUZ are not
                                         consistent, FIOCRUZ shall, and PROTALIX, shall have the right but not the obligation
                                         to, repeat such tests, at FIOCRUZ’s sole cost and expense. In the event PROTALIX
                                         and FIOCRUZ repeated such tests and such inconsistency remains, an independent laboratory
                                         having a confirmed experience in Recombinant Enzyme testing agreed upon by both
                                         PROTALIX and FIOCRUZ in good faith shall be requested to perform the test and such test
                                         shall determine whether a batch can be released or not. The costs of such test by the
                                         laboratory shall be borne by FIOCRUZ. Any batch that has been finally rejected shall
                                         be destroyed at FIOCRUZ‘ expense and FIOCRUZ shall provide PROTALIX with destruction
                                         certificates. In case FIOCRUZ experiences, during the TECHNOLOGY TRANSFER, problems in
                                         meeting the quality of SPECIFICATIONS of PRODUCTS, the PARTIES will define corrective
                                         measures to ensure quality and carry out validation of such measures.



 


		7.4.4	FIOCRUZ
                                         shall be responsible for and reimburse PROTALIX for costs and reasonably agreed upon
                                         expenses incurred to provide technical assistance or training to FIOCRUZ, including all
                                         costs and expenses relating to travel (business class tickets for all flights), local
                                         transportation, hotel, food, and reasonable per diem expenses.



 






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		7.4.5	In
                                         accordance with the payment terms in Article 9, FIOCRUZ shall pay PROTALIX for the technical
                                         assistance and training provided by PROTALIX to FIOCRUZ (as agreed upon by PROTALIX and
                                         FIOCRUZ), at the following rates:



 


	Employee
    (other than Supervisors, Managers or Directors)	[***]
    U.S. dollars per hour
	Supervisor:	[***] U.S. dollars per hour
	Manager:	[***] U.S. dollars per hour
	Senior Manager
    or Director	[***] U.S. dollars per hour


 


ARTICLE
8. USE OF NAMES AND MARKS; PATENT RIGHTS


 


		8.1	Product
                                         Mark License to FIOCRUZ. PROTALIX hereby grants to FIOCRUZ, during the Term,
                                         a non-exclusive, non-transferable, non-sublicensable, limited license to use the Product
                                         Marks as they exist on the labeling and packaging of the FINISHED PACKAGED Product
                                         at the time such FINISHED PACKAGED PRODUCT is supplied to FIOCRUZ by PROTALIX
                                         hereunder in connection with COMMERCIALIZATION of such PRODUCT within the Territory
                                         for the Field in accordance with
                                         the terms and conditions of this AGREEMENT. For the avoidance of doubt, FIOCRUZ is not
                                         granted any rights to display the PRODUCT MARKS other than on the labeling and packaging
                                         of such FINISHED PACKAGED PRODUCT as such PRODUCT MARKS are already displayed thereon.



 


		8.2	Quality
                                         Control.



 


		8.2.1	FIOCRUZ
                                         shall not alter, remove, cover or otherwise modify the labeling or packaging of any FINISHED
                                         PACKAGED PRODUCT (or any PRODUCT MARK thereon). The quality of the FINISHED PACKAGED
                                         PRODUCT sold or otherwise distributed by FIOCRUZ must be of the same quality as the FINISHED
                                         PACKAGED PRODUCT at the time it was supplied to FIOCRUZ hereunder.



 


		8.2.2	FIOCRUZ
                                         shall (a) comply with all applicable Brazilian Laws
                                         pertaining to the proper use and designation of the Product
                                         Marks, (b) modify the labeling and packaging of any FINISHED PACKAGED PRODUCT
                                         as directed by PROTALIX, (c) not use any Product
                                         Mark as a corporate name, business name, or trade name, (d) not use the PRODUCT
                                         MARKS in connection with any SUPPLIED MATERIALS or PRODUCTS other than the FINISHED PACKAGED
                                         PRODUCT or in any manner not expressly permitted hereunder, and (e) not use any Product
                                         Mark in a manner that would reasonably be expected to materially impair the validity,
                                         reputation, or distinctiveness of any Product
                                         Mark.



 


		8.3	Prosecution
                                         and Maintenance of Product Marks.
                                         PROTALIX (or its licensors) shall have the sole right, but not the obligation, through
                                         counsel of its choosing, to prosecute and maintain the Product
                                         Marks in and outside the Territory.



 


		8.4	Enforcement
                                         of Product Marks. FIOCRUZ shall promptly
                                         notify PROTALIX in the event of any actual, potential or suspected infringement of a
                                         Product Mark by any Third
                                         PARTY. [***] shall have the sole right, but not the obligation, to institute litigation
                                         or take other remedial measures in connection with Third
                                         PARTY infringement of Product Marks.
                                         [***] shall be solely entitled to any and all recoveries from THIRD PARTIES resulting
                                         from such litigation or other appropriate action, after reimbursement from such recoveries
                                         of [***] costs and expenses in enforcing the PRODUCT MARKS in such litigation or other
                                         action [***].



 






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		8.5	Use
                                         of Names.



 


		8.5.1	No
                                         right, expressed or implied, is granted by this AGREEMENT to FIOCRUZ to use in any manner
                                         the name or any other trade name of PROTALIX or its Affiliates.



 


		8.5.2	Notwithstanding
                                         the foregoing Article 8.5.1, FIOCRUZ shall have the right to use the PROTALIX corporate
                                         name, subject to PROTALIX’s trademark usage guidelines provided to FIOCRUZ from
                                         time to time, on package inserts, packaging or trade packaging associated with the ProductS
                                         in the Territory solely to the
                                         extent required by applicable Laws. FIOCRUZ
                                         will submit for PROTALIX’s prior written approval a sample of each such proposed
                                         use of the PROTALIX corporate name prior to any use thereof.



 


		8.6	FIOCRUZ
                                         Covenants.



 


		8.6.1	Other
                                         than as expressly permitted in this Article 8, FIOCRUZ shall not (a) use, register, or
                                         apply to register any name, mark, domain name, or logo that consists of or is confusingly
                                         similar to any name, mark, domain name, or logo owned or controlled by PROTALIX or its
                                         AFFILIATES; (b) use any name, mark, domain name, or logo owned or controlled
                                         by PROTALIX or its AFFILIATES together with any other mark or name, without prior
                                         written consent from such PARTY; or (c) take any action whereby any name, mark, domain
                                         name, or logo owned or controlled by PROTALIX
                                         or its AFFILIATES becomes invalid, unenforceable, generic or otherwise impaired.



 


		8.6.2	FIOCRUZ
                                         shall not take any action that in any way might tend to disparage, diminish, or reflect
                                         negatively upon the goodwill, reputation or value of PROTALIX, the PRODUCT, FIOCRUZ or
                                         any name, mark domain name or logo owned or controlled
                                         by PROTALIX or its AFFILIATES.



 


		8.7	Prosecution
                                         and Maintenance of PROTALIX PATENT RIGHTS. PROTALIX shall have the sole right, but
                                         not the obligation, through counsel of its choosing, to prosecute and maintain the PROTALIX
                                         PATENT RIGHTS in and outside the TERRITORY.



 


		8.8	Enforcement
                                         of PROTALIX PATENT RIGHTS. FIOCRUZ shall promptly notify PROTALIX in the event of
                                         any actual, potential or suspected infringement of a PROTALIX PATENT RIGHT by any Third
                                         PARTY. PROTALIX shall have the sole right, but not the obligation, to institute
                                         litigation or take other remedial measures in connection with Third
                                         PARTY infringement of PROTALIX PATENT RIGHTS. FIOCRUZ shall[***] cooperate with
                                         PROTALIX in any such litigation or other remedial measure, including by being named as
                                         a party if necessary to institute or maintain such litigation or other remedial measure.
                                         If FIOCRUZ is so named, it may hire its own counsel at its sole cost and expense to participate
                                         in such litigation or other remedial measure, provided that PROTALIX and its counsel
                                         shall at all times and in all cases control such litigation or other remedial measure.
                                         [***][***] shall be entitled to any and all recoveries from THIRD PARTIES resulting from
                                         such litigation or other remedial action, after reimbursement from such amount of [***]
                                         costs and expenses in enforcing the PROTALIX PATENT RIGHTS in such litigation or action
                                         [***]. 



 






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ARTICLE
9. ROYALTY, REPORTING AND PAYMENT TERMS


 


		9.1	Royalties.
                                         Commencing upon FIOCRUZ’s completion of a Phase III clinical trial and obtaining
                                         a GOVERNMENTAL APPROVAL from ANVISA for the MANUFACTURE entirely by FIOCRUZ of the FINAL
                                         PRODUCT in the TERRITORY, FIOCRUZ shall pay to PROTALIX for the exploitation of the PROTALIX
                                         patent RIGHTs and the PROTALIX TECHNOLOGY
                                         in the TERRITORY a running royalty of [***] of Net
                                         Sales (the “ROYALTY PAYMENTS”), on a quarterly basis in the manner
                                         described in this Article 9. For the avoidance of doubt, (i) FIOCRUZ shall not COMMERCIALIZE
                                         the FINAL PRODUCT until completion of a Phase III clinical trial and obtaining a GOVERNMENTAL
                                         APPROVAL from ANVISA for the MANUFACTURE entirely by FIOCRUZ of the FINAL PRODUCT in
                                         the TERRITORY, and (ii) the requirement to pay ROYALTY PAYMENTS shall survive any termination
                                         or expiration of this AGREEMENT until the expiration of the last to expire PROTALIX patent
                                         in Brazil.



 


		9.2	Royalty
                                         Reporting and Payment. Not later than thirty (30) days after the end of each calendar
                                         quarter during the Term (a “REPORTING
                                         PERIOD”), FIOCRUZ shall (a) submit to PROTALIX a written report setting forth in
                                         reasonable detail (i) gross sales of FINAL Product
                                         during the Reporting Period, (ii)
                                         Net Sales and number of units of FINAL
                                         Product sold or distributed during the
                                         Reporting Period, as well as the computation
                                         of such Net Sales amounts, (iii) inventory
                                         of FINAL  PRODUCT at the beginning and
                                         end of such Reporting Period, and (iv)
                                         all other information related to the business of FIOCRUZ during such Reporting
                                         Period to the extent necessary to enable the calculation of amounts payable hereunder
                                         to be verified, and (b) pay PROTALIX all amounts due for such Reporting
                                         Period.



 


		9.3	Other
                                         Payments. Other than the Royalty Payments, which are subject to Article 9.2, all
                                         other payments (including any reimbursements) arising hereunder shall, unless otherwise
                                         set forth herein, be paid not later than [***] of receipt of an invoice or notice therefor.



 


		9.4	Interest
                                         and other Charges. In the event that PROTALIX does not receive on or prior to the
                                         date when due hereunder all amounts owed by FIOCRUZ to PROTALIX, such unpaid amount shall
                                         be automatically subject to a flat penalty of [***] and monthly adjustment for inflation
                                         based on the positive variation of the [IGP-M/FGV] in the period. Any such amount (as
                                         increased by the penalty and the monetary correction mentioned above) shall bear default
                                         interest from the due date until payment is received by such PARTY at a rate of [***]
                                         per month (the “RATE”). The above additional charges shall be in addition
                                         to, and not in lieu of, any other remedy available to PROTALIX hereunder.



 


		9.5	Taxes
                                         and Other Charges. FIOCRUZ represents and warrants to PROTALIX that, as of the EXECUTION
                                         DATE, there are no Brazilian taxes, customs, duties, assessments, excises, registration
                                         fees, surtax, stamp duties, or any other charges that are required to be levied upon
                                         or withheld from the importation of or assessed against the material furnished or rights
                                         licensed by PROTALIX hereunder, or for or on account of the operation of the FACILITY,
                                         the purchase, MANUFACTURE, COMMERCIALIZATION by or on behalf of FIOCRUZ of the SUPPLIED
                                         MATERIALS and PRODUCTS, or other business of FIOCRUZ contemplated under this AGREEMENT,
                                         including any withholding taxes or any such payments related to the registration or recording
                                         of this AGREEMENT, or any related documents (not including any ANVISA registration fees)
                                         (collectively "TAXES AND FEES"), other than as set forth in Exhibit C (which
                                         shall include details regarding applicable percentages and amounts if any such TAXES
                                         AND FEES, and the PARTY to be responsible therefore). If there are any TAXES AND FEES
                                         under Brazilian LAW that are not set forth on Exhibit C and are, or during the TERM become,
                                         in effect (whether as a result of any change in, or amendment to, Brazilian LAWS or otherwise),
                                         and such TAXES AND FEES materially change the dollar amount or timing of payments expected
                                         to be received by PROTALIX hereunder, then (i) the PARTIES shall discuss in good faith
                                         how to address such change in a mutually acceptable manner to compensate PROTALIX for
                                         such change (e.g., by an increase in pricing of PRODUCT, an increase in amount of PRODUCT
                                         to be purchased, etc.), and (ii) if the PARTIES do not come to an agreement in writing
                                         with respect thereto within thirty (30) calendar days, PROTALIX shall have the right
                                         to terminate this AGREEMENT immediately upon written notice to FIOCRUZ.



 






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		9.6	Currency
                                         and Mode of Payment. All payments to be made hereunder by one PARTY to another PARTY
                                         shall be paid in United States dollars, by electronic transfer in immediately available
                                         funds via either a bank wire transfer, an electronic funds transfer mechanism, at the
                                         paying PARTY’s election, to the bank account designated in Appendix VII or otherwise
                                         designated by the PARTY entitled to receive such payment. ROYALTY PAYMENTS and other
                                         payments due hereunder shall be converted into U.S. dollars at the exchange rate quoted
                                         by Brazilian Central Bank (or its successor in interest) at its market rate for the purchase
                                         of U.S. dollars with the applicable currency that needs to be converted (e.g., the currency
                                         of the Net Sales received) and applied
                                         by that bank on the day such payment is made.



 


		9.7	Permits.
                                         FIOCRUZ assumes the sole responsibility of procuring Permits
                                         for the export of funds as may be required in the Territory;
                                         provided, however, that to the extent that it is impossible to make such
                                         payments due to the “blocking” of funds by LAW, such “blocked”
                                         funds shall be deposited to the credit of PROTALIX, in such depository as PROTALIX designates
                                         or, at the option of PROTALIX, paid directly to a Brazilian entity designated by PROTALIX.
                                         Other than as set forth on Exhibit C, there shall be no deduction or offset from, nor
                                         shall FIOCRUZ have any right to hold back any payment of, any payments owed by FIOCRUZ
                                         hereunder for any reason, including for any uncollectible accounts or other TAXES AND
                                         FEES for which FIOCRUZ is responsible hereunder, or for any banking cost or cost of exchange
                                         or expense of transmitting said funds. FIOCRUZ shall not conduct its business in any
                                         manner intended to reduce the ROYALTY PAYMENTS required to be paid by FIOCRUZ hereunder.



 


ARTICLE
10. OWNERSHIP OF ENHANCEMENTS


 


		10.1	Any
                                         invention made, conceived or reduced to practice by PROTALIX in connection with the performance
                                         of the obligations of this AGREEMENT relating to: (i) a pharmaceutical product with the
                                         same chemical composition as the PRODUCT or (ii) an IMPROVEMENT to the PRODUCT or (iii)
                                         an IMPROVEMENT to the process or specifications provided by PROTALIX to FIOCRUZ, shall
                                         be the exclusive property of PROTALIX. PROTALIX, in its sole discretion, may file for
                                         patent protection in its own name for any such invention. PROTALIX shall, and hereby
                                         does, grant to FIOCRUZ a non-exclusive, irrevocable, perpetual, worldwide, royalty-free
                                         license to use, sublicense, practice and otherwise exploit in any manner any such invention
                                         and any patent or other intellectual property or proprietary rights therein throughout
                                         the world.



 






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ARTICLE
11. CONFIDENTIALITY


 


		11.1	All
                                         non-public information, which is received or made available by or on behalf of PROTALIX
                                         or FIOCRUZ (each, in such capacity, the “RECIPIENT”) from or on behalf of
                                         the other (in such capacity, the “DISCLOSING PARTY”) prior to or during the
                                         Term of this AGREEMENT in connection with
                                         this AGREEMENT or relating hereto, including without limitation, relating to the PRODUCT
                                         or any other pharmaceutical product that contains DRUG SUBSTANCE (“CONFIDENTIAL
                                         INFORMATION”) shall be maintained in confidence and shall not be disclosed to any
                                         Third PARTY nor used for purposes other
                                         than as set forth herein, without the prior written consent of the DISCLOSING PARTY,
                                         except to the extent that the CONFIDENTIAL INFORMATION: (a) is known to the RECIPIENT
                                         prior to disclosure by the DISCLOSING PARTY to the RECIPIENT through no wrongful act
                                         of the RECIPIENT, provided that the RECIPIENT is able to provide competent proof of such
                                         prior knowledge; (b) is obtained by the RECIPIENT in a lawful manner from a source other
                                         than the DISCLOSING PARTY, which source (i) was not required to hold such secrets or
                                         information in confidence, and (ii) was not limited or restricted in its disclosure thereof,
                                         (c) has become public knowledge other than through the fault of the RECIPIENT; (d) has
                                         been developed by the RECIPIENT independently of the information received as established
                                         by written records. The PROTALIX TECHNOLOGY, SPECIFICATIONS and all other information
                                         relating thereto or to the business, operations, research or development of PROTALIX,
                                         shall be deemed included in the CONFIDENTIAL INFORMATION of PROTALIX.



 


		11.2	Notwithstanding
                                         the foregoing, RECIPIENT shall be entitled to disclose CONFIDENTIAL INFORMATION to the
                                         extent disclosure by the RECIPIENT is required: (a) to submit applications by the RECIPIENT
                                         for GOVERNMENTAL APPROVALS (i) in the case of FIOCRUZ as RECIPIENT, to MANUFACTURE and
                                         COMMERCIALIZE the Product in accordance
                                         with the terms and conditions of this AGREEMENT, or (ii) in the case of PROTALIX as the
                                         RECIPIENT, in relation to the COMPOUND, DRUG SUBSTANCE, or PRODUCT, (b) in the case of
                                         PROTALIX as the RECIPIENT, in connection with filing or prosecution of the PROTALIX PATENT
                                         RIGHTS or the PRODUCT MARKS, prosecuting or defending litigation relating thereto or
                                         to the PROTALIX TECHNOLOGY, or (c) by LAW or by any THIRD PARTY LICENSE; provided
                                         that the RECIPIENT shall use commercially reasonable efforts to obtain confidential
                                         treatment of any CONFIDENTIAL INFORMATION to the extent applicable and, if reasonably
                                         practicable under the circumstances, provide the DISCLOSING PARTY with sufficient advance
                                         notice of such intended disclosure so that the DISCLOSING PARTY will have the opportunity
                                         to seek, at its own cost, an appropriate protective order or other remedy, to the extent
                                         applicable, or waive compliance with the provisions of this AGREEMENT. If the DISCLOSING
                                         PARTY seeks a protective order, the RECIPIENT will cooperate. If the DISCLOSING PARTY
                                         fails to obtain a protective order or waive compliance with the relevant portions of
                                         this AGREEMENT, the RECIPIENT will disclose only that portion of information concerning
                                         the COMPOUND or PRODUCT which its legal counsel determines it is required to disclose.



 


		11.3	For
                                         the avoidance of doubt, the [***] shall be deemed included in the CONFIDENTIAL INFORMATION
                                         of PROTALIX. In addition to the obligations set forth in Article 11.1 and 11.2, FIOCRUZ
                                         agrees to (i) treat the [***] with the utmost confidence and in a manner at least as
                                         protective as the manner in which FIOCRUZ protects its own most highly sensitive confidential
                                         information, trade secrets and know-how, (ii) not use such [***] for any purpose other
                                         than for the MANUFACTURING of the FINAL PRODUCT, and (iii) not disclose the information
                                         to any PERSON, other than as permitted pursuant to Article 11.2 to PERSONS (a) who have
                                         a need to know such information for the purpose of MANUFACTURING the FINAL PRODUCT, (b)
                                         who are informed by FIOCRUZ of the confidential nature thereof and the obligations under
                                         this AGREEMENT with respect thereto, and (c) who agree in writing with PROTALIX to comply
                                         with the obligations of FIOCRUZ under this Article 11 with respect thereto.



 


		11.4	The
                                         confidentiality obligations set forth in this Article 11 shall survive the termination
                                         or expiration of this AGREEMENT until fifteen (15) years from the EFFECTIVE DATE. Notwithstanding
                                         anything to the contrary herein, FIOCRUZ's obligations under this Article 11 with respect
                                         to the [***] shall survive the termination or expiration of this AGREEMENT for no less
                                         than fifteen (15) years from the completion of the transfer of such [***] to FIOCRUZ.



 






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ARTICLE
12. TERM AND TERMINATION


 


		12.1	This
                                         AGREEMENT shall come into force and effect as of the EFFECTIVE DATE, and shall remain
                                         in force for seven (7) years following the EFFECTIVE DATE, and may be renewed upon the
                                         written agreement of FIOCRUZ and PROTALIX, if INPI authorizes such renewal, for additional
                                         five (5) years periods. If in the end of the initial seven (7) year period or any such
                                         renewal period the TECHNOLOGY TRANSFER has not been COMPLETED, the PARTIES may renew
                                         the AGREEMENT for the period needed for the COMPLETION of the TECHNOLOGY TRANSFER in
                                         accordance with the foregoing sentence (the initial period and any such renewal periods,
                                         collectively, "TERM 1"), and upon COMPLETION of the TECHNOLOGY TRANSFER TERM
                                         1 shall immediately and automatically expire and TERM 2 shall immediately and automatically
                                         commence.



 


		12.2	FIOCRUZ
                                         shall pay royalties hereunder to PROTALIX for the PROTALIX PATENT RIGHTS for the period
                                         of time beginning on the completion of TERM 1 until the later of expiration of the last
                                         to expire PROTALIX patent in Brazil in accordance with ARTICLE 9 ("TERM 2").
                                         The TERM 2 is valid only for the purpose of royalties payment, any terms and conditions
                                         relating to PROTALIX PATENT RIGHTS or PRODUCT MARKS in any way (including, for the avoidance
                                         of doubt, all license rights and restrictions), and any other obligations that survive
                                         termination or expiration of this AGREEMENT. The other obligations of this AGREEMENT
                                         (i.e., those obligations not referenced in the foregoing sentence) shall expire with
                                         the end of TERM 1.



 


		12.3	Without
                                         limiting any other provision of this AGREEMENT, this AGREEMENT may be terminated by PROTALIX
                                         as follows:



 


		(a)	if
                                         FIOCRUZ materially breaches its representations or warranties made in this AGREEMENT,
                                         or materially breaches or materially defaults in the performance or observance of any
                                         of its obligations under this AGREEMENT, and such breach or default is not cured within
                                         [***] after the giving of written notice by PROTALIX, specifying such breach or default,
                                         then PROTALIX shall have the right to terminate this AGREEMENT by providing FIOCRUZ written
                                         notice following the expiration of such [***][***] period (such termination to be effective
                                         upon receipt of such termination notice);



 


		(b)	immediately
                                         upon written notice to FIOCRUZ if any GOVERNMENTAL AUTHORITY announces plans to privatize
                                         FIOCRUZ and a competitor of PROTALIX acquires FIOCRUZ or any part of FIOCRUZ that is
                                         responsible for the MANUFACTURE or COMMERCIALIZATION of PRODUCTS;



 


		(c)	if
                                         FIOCRUZ fails to make any payment when due in accordance with the terms and conditions
                                         of this AGREEMENT and such failure to pay is not cured within [***] after the giving
                                         of written notice by PROTALIX of such failure, then PROTALIX shall have the right to
                                         terminate this AGREEMENT by providing FIOCRUZ written notice following the expiration
                                         of such [***] period (such termination to be effective upon receipt of such termination
                                         notice);



 


		(d)	immediately
                                         upon written notice if FIOCRUZ undergoes a change of control (as such term is defined
                                         in the definition of AFFILIATE);



 






    	27



    	 



    

 


		(e)	immediately
                                         upon written notice if FIOCRUZ orders, purchases, accepts or otherwise imports from a
                                         third party any product that is a therapy for the treatment of Gaucher Disease;



 


		(f)	immediately
                                         upon written notice in the event of: (i) FIOCRUZ’s insolvency or bankruptcy, (ii)
                                         a liquidation committee or team being formed pursuant to the liquidation rules or Laws
                                         of any applicable jurisdiction with respect to FIOCRUZ, or substantially all of
                                         the property or assets of FIOCRUZ is under custody by the liquidation committee under
                                         the provisions of any bankruptcy, insolvency, or similar LAW, (iv) FIOCRUZ making an
                                         assignment for the benefit of its creditors, or (v) FIOCRUZ being dissolved; and



 


		(g)	The
                                         purchase by and supply to FIOCRUZ of SUPPLIED MATERIALS during each STAGE in order to
                                         proceed to the subsequent STAGE of TECHNOLOGY TRANSFER shall occur subject to [***] and
                                         PROTALIX’s prior written approval of such quantities. In the event that (i) PROTALIX
                                         does not agree in advance in writing with such quantities proposed by the Brazilian MOH
                                         or (ii) the [***] and corresponding PURCHASE ORDERS issued by FIOCRUZ to PROTALIX for
                                         any year are less than the amount set forth in the following chart for any given year,
                                         PROTALIX shall have the right to terminate this AGREEMENT immediately upon providing
                                         FIOCRUZ written notice:



 


Yearly
Termination Threshold


 


	Year	 	Termination
    Threshold
	From January 1, 2014
    until July 31, 2015	 	[***]
	From August1, 2015
    until July 31, 2016	 	[***]
	From August 1, 2016
    until July 31, 2017	 	[***]
	From August 1, 2017
    until July 31, 2018	 	[***]
	From August 1, 2018
    until July 31, 2019	 	[***]
	From August 1, 2019
    until July 31, 2020	 	[***]


 


 


		12.4	Without
                                         limiting any other provision of this AGREEMENT, this AGREEMENT may be terminated by FIOCRUZ
                                         as follows:



 


		(a)	if
                                         PROTALIX materially breaches its representations or warranties made in this AGREEMENT,
                                         or materially breaches or defaults in the performance or observance of any of its respective
                                         obligations under, this AGREEMENT, and such breach or default is not cured within [***]
                                         after the giving of written notice by FIOCRUZ to PROTALIX specifying such breach or default,
                                         then FIOCRUZ shall have the right to terminate this AGREEMENT by providing PROTALIX written
                                         notice following the expiration of such [***] period (such termination to be effective
                                         upon receipt of such termination notice);



 






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		(b)	immediately
                                         upon notice to PROTALIX if FIOCRUZ due to any change in Brazilian LAW is unable to maintain
                                         compliance with this AGREEMENT; provided FIOCRUZ used its best efforts to prevent
                                         any of the foregoing events from occurring and to mitigate or cure any effects thereof
                                         prior to exercising such termination right; and



 


		(c)	if
                                         the pharmaceutical product plant cell expressed recombinant Glucocerebrosidase
                                         in a finished dosage form of a drug product that contains DRUG SUBSTANCE (excluding any
                                         ORAL FORMULATION) is recalled by both ANVISA and the United States Food and Drug Administration
                                         in a manner that is not curable within [***]. In the case of termination pursuant to
                                         this Section 12.4(c), FIOCRUZ shall not be required to pay any outstanding payment obligations
                                         incurred prior to the effective date of such termination under this AGREEMENT for any
                                         PRODUCT batches subject to such recall.



 


		12.5	FIOCRUZ
                                         shall notify PROTALIX at least twenty (20) days prior to the occurrence of any of the
                                         events or scenarios described in Articles 12.3(b) and (d) and 12.4(b), or, if not possible
                                         on such time frame, as soon as possible prior to such occurrence.



 


		12.6	Termination
                                         of this AGREEMENT shall be in addition to, and not in lieu of, any other rights or remedies
                                         available to the terminating PARTY under this AGREEMENT or applicable Brazilian LAW.
                                         Termination of this AGREEMENT in accordance with the terms hereof shall not be the basis
                                         for any compensation or other claim for damages resulting therefrom (including any lost
                                         profits due to such termination), other than as set forth in Section 12.7.



 


		12.7	Termination
                                         of this AGREEMENT for any reason (a) shall be without prejudice to and shall not impair
                                         or limit in any manner PROTALIX’s right to receive payment from FIOCRUZ in respect
                                         of any payment obligations incurred prior to the effective date
                                         of such termination, whether or not the due date for such payment is after such
                                         effective date of termination and (b) shall not release a PARTY hereto from any indebtedness,
                                         liability, payment or other obligation incurred hereunder (including liability for breach
                                         of this AGREEMENT) by such PARTY prior to the effective date of such termination.



 


ARTICLE
13. EFFECTS OF TERMINATION


 


		13.1	Except
                                         as expressly provided for hereunder, upon the effective date of termination of this AGREEMENT
                                         in accordance with this AGREEMENT, all licenses and rights granted to FIOCRUZ herein
                                         shall automatically and immediately terminate and FIOCRUZ shall immediately cease all
                                         use of the PROTALIX TECHNOLOGY, PROTALIX PATENTS, SPECIFICATIONS and any other CONFIDENTIAL
                                         INFORMATION provided to FIOCRUZ hereunder.



 


		13.2	FIOCRUZ
                                         shall, promptly after termination of this AGREEMENT, provide to PROTALIX or its designee
                                         (or upon PROTALIX’s direction with respect to specific items, destroy) all documents,
                                         data, reports, records, regulatory correspondence and other materials and information
                                         (and any copies thereof) that contain or are related to the PROTALIX TECHNOLOGY, CONFIDENTIAL
                                         INFORMATION disclosed by PROTALIX, and the COMPOUNDS, DRUG SUBSTANCES, CELL BANK, reagents,
                                         and PRODUCTS (including and GOVERNMENTAL APPROVALS and regulatory filings with respect
                                         thereto) in a form and format useable by PROTALIX. Upon such termination, FIOCRUZ shall
                                         assign and transfer to PROTALIX or its designee all of FIOCRUZ’s right, title and
                                         interest in and to all GOVERNMENTAL APPROVALS for or related to the PRODUCTS, COMPOUND
                                         or DRUG SUBSTANCE in the Territory and
                                         any related data and other materials transferred or delivered or deliverable by FIOCRUZ
                                         pursuant to this Article 13.2. FIOCRUZ shall execute and deliver to PROTALIX such documents,
                                         and take such other actions requested by PROTALIX that are necessary or appropriate to
                                         carry out the intent and purposes of this Article 13.2 and to perfect and confirm such
                                         assignment, including submitting letters to the GOVERNMENTAL AUTHORITIES in forms reasonably
                                         acceptable to PROTALIX.



 






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		13.3	Following
                                         termination of this AGREEMENT, upon a PARTY’s reasonable request and at such requesting
                                         PARTY’s cost, the other PARTY shall reasonably cooperate with the requesting PARTY
                                         (including by providing relevant information and data) in connection with any requests
                                         or investigations of a regulatory authority, any Third
                                         PARTY claims against the requesting PARTY, or such requesting PARTY’s efforts
                                         to comply with Laws, relating to the PRODUCTS,
                                         COMPOUND, DRUG SUBSTANCE, PROTALIX TECHNOLOGY, or SPECIFICATIONS.



 


		13.4	Upon
                                         termination of this AGREEMENT, FIOCRUZ shall terminate the MANUFACTURE and COMMERCIALIZATION
                                         of any COMPOUND, DRUG SUBSTANCE, or PRODUCTS and, at PROTALIX’s sole option, shall
                                         (a) only in the event of termination by PROTALIX pursuant to Article 12.3, arrange the
                                         sale to PROTALIX or its designee at FIOCRUZ’s cost of all (or at PROTALIX’s
                                         option, a portion of the) SUPPLIED MATERIAL, DRUG SUBSTANCES and PRODUCTS in FIOCRUZ’s
                                         inventory, and/or (b) dispose of all (or at PROTALIX’s option, a portion of the)
                                         SUPPLIED MATERIAL, DRUG SUBSTANCES and PRODUCTS in FIOCRUZ’s inventory.



 


		13.5	Upon
                                         termination of this AGREEMENT, FIOCRUZ shall cooperate with PROTALIX to effect a cancellation
                                         or termination of any recordation of this AGREEMENT with the appropriate Governmental
                                         Authorities in the Territory, and
                                         the FIOCRUZ will grant, and hereby does grant, to PROTALIX an irrevocable power of attorney
                                         coupled with an interest to effect such cancellation within twenty (20) days after the
                                         termination of this AGREEMENT.



 


ARTICLE
14. BOOKS AND RECORDS


 


		14.1	FIOCRUZ
                                         shall keep and maintain during the TERM and for one (1) years after the termination of
                                         this AGREEMENT, accurate and correct books and records setting forth gross sales of the
                                         PRODUCTS, Net
                                         Sales, number of units of PRODUCT sold,
                                         inventory of PRODUCT and all other information
                                         related to the business of FIOCRUZ necessary to enable the calculation of amounts payable
                                         hereunder to be verified and the confirmation of FIOCRUZ’s compliance with this
                                         AGREEMENT. PROTALIX shall have the right to request that an independent accountant reasonably
                                         selected by it examine FIOCRUZ’s books and records at any reasonable time, upon
                                         reasonable notice and at the Facilities or
                                         other facilities where such books and
                                         records are normally kept. The opinion of such independent accountants regarding such
                                         payments shall be binding on the PARTIES, other than in the case of manifest error. Except
                                         as set forth below, the auditing PARTY shall bear the cost of any such examination and
                                         review.



 


		14.2	If
                                         the review of FIOCRUZ’s records reveals that FIOCRUZ failed to accurately report
                                         information pursuant to Article 9.2 or otherwise underpaid any amounts due hereunder,
                                         then FIOCRUZ’s shall promptly pay PROTALIX the amount of any underpayment due hereunder,
                                         which shall be subject to all additional charges mentioned in Article 9.4 above, including
                                         the default interest at the Rate. If such
                                         discrepancy is greater than five percent (5%) of the amount due, FIOCRUZ shall promptly
                                         reimburse all costs incurred by PROTALIX in connection with such examination.



 






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ARTICLE
15. GOVERNING LAW


 


		15.1	The
                                         PARTIES agree that this AGREEMENT shall be governed by and construed in accordance with
                                         the laws of Brazil and the courts of Brazil shall have jurisdiction over any disputes
                                         arising in connection with this AGREEMENT. It is acknowledged that PROTALIX and FIOCRUZ
                                         shall not be excluded from adjudicating and enforcing their rights under this AGREEMENT
                                         as relate to countries other than Brazil (including but not limited to enforcing any
                                         restriction on a PARTY outside the TERRITORY) in courts other than the courts of Brazil.



 


ARTICLE
16. INDEMNIFICATION; DISCLAIMER; LIMITATION OF LIABILITY


 


		16.1	FIOCRUZ
                                         shall indemnify, defend and hold PROTALIX and its AFFILIATES and their respective directors,
                                         officers, shareholders, representatives, agents, successors, assigns, licensors and employees
                                         harmless from and against all Losses,
                                         in each case to the extent arising out of (a) any acts or omissions of FIOCRUZ or any
                                         of its Affiliates, agents, consultants
                                         or contractors in connection with its activities under this AGREEMENT, including MANUFACTURE,
                                         use or sale of the SUPPLIED MATERIALS, COMPOUND, Drug
                                         Substance and/or ProductS, unless
                                         such Losses are for Losses
                                         to which FIOCRUZ is entitled to indemnification pursuant to Article 16.2, as applicable,
                                         (b) the breach of any covenant, warranty or representation made by FIOCRUZ under this
                                         AGREEMENT, or (c) the negligence, recklessness, or willful misconduct of, or violation
                                         of Brazilian LAW by, FIOCRUZ or any of its Affiliates,
                                         agents, consultants or contractors.



 


		16.2	PROTALIX
                                         shall indemnify, defend and hold FIOCRUZ and its AFFILIATES and their respective directors,
                                         officers, shareholders, representatives, agents, successors, assigns, and employees harmless
                                         from and against all Losses arising from
                                         Third PARTY Claims
                                         that the MANUFACTURE and sale of the PRODUCTS by FIOCRUZ within the Territory
                                         for the Field in accordance with
                                         the terms and conditions hereof, infringes any Patent
                                         Rights of any THIRD PARTY.



 


		16.3	For
                                         purposes of this AGREEMENT, “THIRD PARTY CLAIM” means a claim asserted by
                                         a Third PARTY (in no event to include
                                         any Affiliate of either PARTY) against
                                         a PARTY or any of its Affiliates, or any
                                         of their respective directors, officers, shareholders, representatives, agents, successors,
                                         assigns, licensors or employees. In the event a Third
                                         PARTY Claim is asserted or LOSSES are incurred with respect to any matter for
                                         which a PARTY or any of its Affiliates,
                                         or any of their respective directors, officers, shareholders, representatives, agents,
                                         successors, assigns, licensors and employees (the “INDEMNIFIED PARTY”) is
                                         entitled to indemnification hereunder, then the Indemnified
                                         PARTY shall promptly notify in writing the PARTY obligated to indemnify the Indemnified
                                         PARTY (the “INDEMNIFYING PARTY”) thereof; provided, however,
                                         that no delay on the part of the Indemnified
                                         PARTY in notifying the Indemnifying PARTY
                                         shall relieve the Indemnifying PARTY
                                         from any obligation hereunder unless (and then only to the extent that) the Indemnifying
                                         PARTY is prejudiced thereby.



 






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		16.4	The
                                         Indemnifying PARTY shall assume direction
                                         and control of the defense, litigation, settlement, appeal or other disposition of the
                                         Third PARTY Claim (including the right
                                         to settle the claim solely for monetary consideration) with counsel selected by the Indemnifying
                                         PARTY and reasonably acceptable to the Indemnified
                                         PARTY. The Indemnified PARTY shall
                                         have the right to join in (including the right to conduct discovery, interview and examine
                                         witnesses and participate in all settlement conferences), but not control, at its own
                                         expense, the defense of any Third PARTY Claim
                                         that the Indemnifying PARTY is
                                         defending as provided in this AGREEMENT. Notwithstanding anything to the contrary contained
                                         herein, an Indemnified PARTY shall be
                                         entitled to assume the defense of any Third PARTY
                                         Claim with respect to the Indemnified
                                         PARTY, (i) upon written notice to the Indemnifying
                                         PARTY, in which case the Indemnifying
                                         PARTY shall be relieved of liability under Article 16.1 or 16.2, as applicable,
                                         solely for such Third PARTY Claim and
                                         related Losses, or (ii) in the event the
                                         INDEMNIFYING PARTY refuses or fails to assume the defense as required hereunder, in which
                                         case the Indemnifying PARTY shall not
                                         be relieved of liability under Article 16.1 or 16.2, as applicable, solely for such Third
                                         PARTY Claim and related Losses.



 


		16.5	FIOCRUZ
                                         will not enter into any settlement of any THIRD PARTY CLAIM for which PROTALIX or any
                                         of its Affiliates, or any of their respective
                                         directors, officers, shareholders, representatives, agents, successors, assigns, licensors
                                         or employees is entitled to indemnification hereunder involving PROTALIX TECHNOLOGY,
                                         PROTALIX PATENT RIGHTS, CONFIDENTIAL INFORMATION of PROTALIX, PRODUCT MARKS, COMPOUND,
                                         Drug Substance, PRODUCTS
                                         or SUPPLIED MATERIALS, without such Indemnified
                                         PARTY’s prior written consent. Without limiting the foregoing, FIOCRUZ shall
                                         not, without the written consent of the Indemnified
                                         PARTY (which consent shall not be unreasonably withheld), effect any settlement
                                         of any pending or threatened litigation in which the Indemnified
                                         PARTY has sought indemnification hereunder by FIOCRUZ, unless such settlement
                                         involves solely monetary damages and includes an unconditional release of the Indemnified
                                         PARTY from all liability on claims that are the subject matter of such litigation.



 


		16.6	IN
                                         NO EVENT SHALL EITHER PARTY OR ANY OF ITS RESPECTIVE AFFILIATES BE LIABLE UNDER THIS
                                         AGREEMENT FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, WHETHER IN CONTRACT,
                                         WARRANTY, TORT, NEGLIGENCE, STRICT LIABILITY OR OTHERWISE, INCLUDING LOSS OF PROFITS
                                         OR REVENUE, SUFFERED BY PROTALIX, FIOCRUZ OR ANY OF THEIR RESPECTIVE AFFILIATES. THE
                                         FOREGOING SENTENCE SHALL NOT LIMIT (A) THE OBLIGATIONS OF EITHER PARTY TO INDEMNIFY THE
                                         OTHER PARTY AS PROVIDED HEREUNDER, (B) ANY LIABILITIES RESULTING FROM A BREACH OF THE
                                         CONFIDENTIALITY OBLIGATIONS UNDER ARTICLE 11 OR FROM USE OF ANY INTELLECTUAL PROPERTY
                                         OTHER THAN IN ACCORDANCE WITH THE LICENSE GRANTED PURSUANT TO ARTICLE 4, OR (C) ANY PAYMENT
                                         OBLIGATIONS UNDER THIS AGREEMENT. EXCEPT FOR LOSSES TO
                                         THE EXTENT RESULTING FROM PROTALIX'S GROSS NEGLIGENCE, FRAUD OR WILLFUL MISCONDUCT, IN
                                         NO EVENT SHALL PROTALIX'S TOTAL LIABILITY TO FIOCRUZ ARISING IN CONNECTION WITH THE SUPPLY
                                         OF SUPPLIED MATERIALS PURSUANT TO SECTION 6 HEREOF EXCEED, ON A SUPPLIED MATERIAL-BY-SUPPLIED
                                         MATERIAL BASIS, THE TOTAL AMOUNT PAID BY FIOCRUZ FOR SUCH SUPPLIED MATERIAL.
                                         



 






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ARTICLE
17. WARRANTIES


 


		17.1	Each
                                         PARTY hereby represents and warrants as of the EXECUTION DATE and the Effective
                                         Date that such PARTY has the requisite corporate power and authority to execute
                                         and deliver this AGREEMENT and to perform its obligations hereunder, and that the execution,
                                         delivery and performance of this AGREEMENT by such PARTY has been duly and validly authorized
                                         and approved by proper corporate action on the part of such PARTY, and such PARTY has
                                         taken all other action required by LAW, its certificate of incorporation, by-laws or
                                         other organizational documents, required to authorize such execution, delivery and performance.
                                         Assuming due authorization, execution and delivery on the part of the other PARTY, each
                                         PARTY represents and warrants as of the EFFECTIVE DATE that this AGREEMENT constitutes
                                         a legal, valid and binding obligation of such PARTY, enforceable against such PARTY in
                                         accordance with its terms.



 


		17.2	FIOCRUZ
                                         hereby represents and warrants to PROTALIX as of the EXECUTION DATE and the EFFECTIVE
                                         DATE, and covenants to PROTALIX, as follows:



 


		(a)	In
                                         connection with the COMPOUND, Drug Substance
                                         and ProductS Manufactured by, or
                                         under authority of, FIOCRUZ: (i) any FACILITY and all equipment, tooling and molds utilized
                                         in the Manufacture hereunder by FIOCRUZ
                                         shall be maintained in good operating condition and shall be maintained and operated
                                         in accordance with all applicable Brazilian Laws
                                         and GMP, (ii) the Manufacturing, COMMERCIALIZATION
                                         and storage operations, procedures and processes utilized by FIOCRUZ hereunder
                                         (including any Facility) shall be in full
                                         compliance with all applicable Brazilian Laws,
                                         including GMP and Brazilian health and safety Laws,
                                         (iii) FIOCRUZ shall hold all Permits required
                                         by any Governmental Authority for it to
                                         ManufacturE, COMMERCIALIZE and otherwise
                                         distribute the COMPOUND, Drug Substance
                                         and PRODUCTS in accordance with this AGREEMENT (subject to Article 5.1.5), and (iv) the
                                         PRODUCTS, or its containers, shall be marked by FIOCRUZ in accordance with the applicable
                                         patent marking LAWS.



 


		(b)	The
                                         COMPOUND, Drug Substance and ProductS,
                                         as applicable, shall be Manufactured,
                                         COMMERCIALIZED, packaged, labeled, handled, stored and shipped by FIOCRUZ, in accordance
                                         with the SPECIFICATIONS and in compliance with all applicable Brazilian Laws
                                         and GMP, and in accordance with the PHARMACOVIGILANCE
                                         AGREEMENT and any other quality assurance requirements provided in writing to
                                         FIOCRUZ by PROTALIX, and this AGREEMENT.



 


		(c)	FIOCRUZ
                                         shall not allow the introduction into the Drug
                                         SUBSTANCE or PRODUCTS of (i) any material that has not been used, handled or stored
                                         in accordance with the Specifications,
                                         all applicable Brazilian Laws, GMP, the
                                         PHARMACOVIGILANCE AGREEMENT, (ii) any
                                         material that would cause the Drug Substance
                                         or  ProductS to be adulterated
                                         or misbranded within the meaning of any Brazilian
                                         Laws, and (iii) any defects in material and workmanship.



 


		(d)	Each
                                         PARTY does not, to such PARTY's knowledge, currently employ and will not knowingly employ
                                         during the Term, and does not, to such
                                         PARTY's knowledge, use as a subcontractor and will not knowingly use as a subcontractor
                                         during the Term, and such subcontractors
                                         do not, to such PARTY's knowledge, currently employ and will not employ or engage during
                                         the Term, any Person
                                         that has been debarred or has otherwise been disqualified or suspended from performing
                                         scientific or clinical investigations or otherwise subjected to any restrictions or sanctions
                                         by the ANVISA or any other Governmental Authority
                                         or professional body with respect to the performance of scientific or clinical
                                         investigations, or any Person finally
                                         convicted of a criminal offense, with no existing rights to appeal such conviction, in
                                         relation to: (i) the development or approval (including the process for development or
                                         approval) of an abbreviated drug application, (ii) the development or approval of any
                                         drug product or otherwise relating to the regulation of any drug product, or (iii) bribery,
                                         payment of illegal gratuities, fraud, perjury, racketeering, blackmail, extortion, falsification
                                         or destruction of records or interference with, obstruction of an investigation into
                                         a prosecution of any criminal offense.



 






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		(e)	FIOCRUZ
                                         shall operate and maintain all equipment used at the Facilities
                                         in a safe manner and provide adequate employee training with respect thereto.



 


		(f)	Each
                                         PARTY has not, to such PARTY's knowledge, and will not knowingly offer or pay, or authorize
                                         such offer or payment, of any money or anything of value or improperly seek to influence
                                         any Government Official in connection
                                         with this AGREEMENT. For purposes of this Article, a “GOVERNMENT OFFICIAL”
                                         is defined as and includes: (i) any elected or appointed government official (e.g., a
                                         member of a ministry of health); (ii) any employee or person acting for or on behalf
                                         of a government official, agency, or enterprise performing a governmental function; (iii)
                                         any political party, officer, employee, or person acting for or on behalf of a political
                                         party or candidate for public office; (iv) an employee or person acting for or on behalf
                                         of a public international organization; or (v) any person otherwise categorized as a
                                         Government Official under local law where
                                         “government” includes all levels and subdivisions of non-U.S. governments
                                         (i.e., local, regional, or national and administrative, legislative, or executive).



 


		(g)	FIOCRUZ
                                         shall (i) not use, sell or distribute the PRODUCTS
                                         or any other product that contains the DRUG SUBSTANCE, for any purpose other than
                                         as set forth herein, (ii) use the SUPPLIED MATERIALS and PROTALIX TECHNOLOGY solely for
                                         the purpose of converting such SUPPLIED MATERIALS into the PRODUCTS for sale within the
                                         Territory in the Field,
                                         in accordance with this AGREEMENT, (iii) not source materials for inclusion in
                                         the PRODUCTS other than through PROTALIX, and (iv) not sell, distribute or use a Product
                                         if it does not conform with the SPECIFICATIONS.



 


		17.3	PROTALIX
                                         hereby represents and warrants to FIOCRUZ that, to its knowledge, as of the EXECUTION
                                         DATE and the Effective Date:



 


		(a)	The
                                         COMPOUND, DRUG SUBSTANCE, BULK PRODUCT, NAKED VIAL, CELL BANK and the FINISHED PACKAGED
                                         PRODUCT supplied by PROTALIX to FIOCRUZ hereunder is in full compliance with all applicable
                                         Brazilian Laws, including GMP and Brazilian
                                         health and safety Laws.



 


		(b)	The
                                         PROTALIX PATENT RIGHTS, PROTALIX TECHNOLOGY, PRODUCT MARKS or CONFIDENTIAL INFORMATION
                                         does not infringe any THIRD PARTY rights.



 


		17.4	PROTALIX
                                         hereby covenants to FIOCRUZ that the COMPOUND, DRUG SUBSTANCE, BULK PRODUCT, NAKED VIAL,
                                         CELL BANK and the FINISHED PACKAGED PRODUCT supplied by PROTALIX to FIOCRUZ hereunder
                                         shall be in full compliance with GMP.



 


		17.5	Disclaimer
                                         of Warranty. EXCEPT AS OTHERWISE EXPRESSLY STATED IN THIS AGREEMENT, NEITHER PARTY
                                         MAKES ANY REPRESENTATION OR WARRANTY OF ANY KIND WITH RESPECT TO THE COMPOUND, DRUG SUBSTANCE,
                                         THE PRODUCT, PROTALIX PATENT RIGHTS, PROTALIX TECHNOLOGY, PRODUCT MARKS OR CONFIDENTIAL
                                         INFORMATION. EXCEPT AS OTHERWISE EXPRESSLY STATED IN THIS AGREEMENT, EACH PARTY EXPRESSLY
                                         DISCLAIMS ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY,
                                         FITNESS FOR A PARTICULAR PURPOSE AND NON-INFRINGEMENT.



 






    	34



    	 



    

 


ARTICLE
18. PHARMACOVIGILANCE AGREEMENT/QUALITY AGREEMENT


 


		18.1	The
                                         PARTIES agree to comply with the terms and conditions of the Pharmacovigilance Agreement
                                         set forth as Appendix VIII.



 


		18.2	The
                                         PARTIES agree in good faith to establish mutually agreeable quality guidelines following
                                         the EXECUTION DATE and prior to distribution of PRODUCT by FIOCRUZ, which shall cover,
                                         amongst other matters, delivery and storage of PRODUCT by FIOCRUZ.  The PARTIES
                                         agree to comply with such quality guidelines during the TERM.



 


ARTICLE
19. APPROVALS


 


		19.1	Except
                                         where expressly stated otherwise herein, all approvals and consent rights of a PARTY
                                         under this AGREEMENT shall be in such PARTY’s sole and absolute but good faith
                                         discretion. Any approval or consent may be subject to such conditions as such PARTY deems
                                         appropriate or be granted on a “test” or temporary basis, in each case to
                                         the extent identified to the PARTY requesting such approval or consent. If a PARTY does
                                         not grant any required approval or consent within ten (10) business
                                         Days of any submission or request for approval or consent, such submission or
                                         request shall be deemed to be disapproved.



 


ARTICLE
20. MISCELLANEOUS


 


		20.1	Force
                                         Majeure. Neither PARTY shall be liable to the other PARTY for any losses or damages
                                         attributable to a default under or breach of this AGREEMENT that is the result of war
                                         (whether declared or undeclared), acts of God, revolution, acts of terror, fire, earthquake,
                                         flood, pestilence, riot, enactment or change of LAW (following the EXECUTION
                                         Date) making performance of this AGREEMENT by such PARTY impossible, accident(s),
                                         labor trouble, shortage of or inability to obtain material equipment or transport or
                                         any other cause beyond the reasonable control of such PARTY (each, a “FORCE MAJEURE
                                         EVENT”); provided that if such a cause occurs, then the PARTY affected will
                                         promptly notify the other PARTY of the nature and likely result and duration (if known)
                                         of such cause and use its commercially reasonable efforts to avoid or remove such causes
                                         of nonperformance as soon as is reasonably practicable. Upon termination of the Force
                                         Majeure Event, the performance of any suspended obligation or duty shall promptly
                                         recommence. If the event lasts for a period of longer than one (1) month, the PARTIES
                                         shall meet and work diligently to implement appropriate remedial measures. Notwithstanding
                                         anything to the contrary herein, despite the existence of any such Force
                                         Majeure Event affecting FIOCRUZ's ability to pay all monies due hereunder for
                                         PRODUCTS delivered or services or licenses provided hereunder, FIOCRUZ shall pay any
                                         such amounts immediately upon the termination of such FORCE MAJEURE EVENT without penalty
                                         for any such delay during the continuance of the FORCE MAJEURE EVENT, in accordance with
                                         the terms hereof.



 


		20.2	Severability.
                                         If and solely to the extent that any provision of this AGREEMENT shall be invalid or
                                         unenforceable, such offending provision shall be of no effect and shall not affect the
                                         enforceability or validity of the remainder of this AGREEMENT or any of its provisions;
                                         provided, however, the PARTIES shall use their respective reasonable efforts to
                                         mutually agree to replace the invalid provisions in a manner that best accomplishes the
                                         original intentions of the PARTIES.



 






    	35



    	 



    

 


		20.3	Waivers.
                                         Any term or condition of this AGREEMENT may be waived at any time by the PARTY that is
                                         entitled to the benefit thereof, but no such waiver shall be effective unless set forth
                                         in a written instrument duly executed by or on behalf of the PARTY waiving such term
                                         or condition. Neither the waiver by any PARTY of any term or condition of this AGREEMENT
                                         nor the failure on the part of any PARTY, in one or more instances, to enforce any of
                                         the provisions of this AGREEMENT or to exercise any right or privilege, shall be deemed
                                         or construed to be a waiver of such term or condition for any similar instance in the
                                         future or of any subsequent breach hereof. All rights, remedies, undertakings, obligations
                                         and agreements contained in this AGREEMENT shall be cumulative and none of them shall
                                         be a limitation of any other remedy, right, undertaking, obligation or agreement.



 


		20.4	Entire
                                         Agreement; Amendments. This AGREEMENT (together with any agreements between the PARTIES
                                         expressly contemplated to be entered into by this AGREEMENT) sets forth the entire agreement
                                         and understanding between the PARTIES as to the subject matter hereof and supersedes
                                         all agreements or understandings, verbal or written, made between FIOCRUZ and PROTALIX
                                         before the EXECUTION DATE with respect to the subject matter hereof.  All
                                         Confidential Information disclosed between
                                         FIOCRUZ and PROTALIX prior to the Effective Date
                                         will be deemed to have been disclosed pursuant to and under this AGREEMENT. None
                                         of the terms of this AGREEMENT shall be amended, supplemented or modified except in writing
                                         signed by the PARTIES.



 


		20.5	Survival.
                                         The provisions of Articles 1, 4.3, 4.6, 4.7, 8.6, 9 (for any payment obligations incurred
                                         during the TERM until the date of termination), 10, 11, 12.6, 12.7, 13, 14, 15, 16, 17,
                                         19 and 20, as well as (i) any other Articles, Exhibits, Schedules or Appendices or defined
                                         terms referred to in such Articles necessary to give them effect and (ii) any other provision
                                         that by its terms expressly survives termination of this AGREEMENT, shall survive termination
                                         of this AGREEMENT and remain in force until discharged in full. Furthermore, any other
                                         provisions required to interpret and enforce the PARTIES’ rights and obligations
                                         or to wind up their outstanding obligations under this AGREEMENT shall survive to the
                                         extent required, including any payment obligations incurred during the Term
                                         or pursuant to any surviving Article.



 


		20.6	Assignment;
                                         Binding Effect. Neither this AGREEMENT nor any rights or obligations of FIOCRUZ in,
                                         to or under this AGREEMENT may be assigned or otherwise transferred by FIOCRUZ without
                                         the prior written consent of PROTALIX. For purposes of this AGREEMENT, an “assignment”
                                         includes any change of control of FIOCRUZ (as such term is defined in the definition
                                         of AFFILIATES) or assignment by operation of LAW. PROTALIX may assign this AGREEMENT
                                         or any of its rights or obligations hereunder, in whole or in part, with the prior consent
                                         of FIOCRUZ (such consent not to be unreasonably withheld or delayed); provided
                                         that, for the avoidance of doubt, no such consent of FIOCRUZ shall be required for an
                                         assignment in connection with a change of control (as such term is defined in the definition
                                         of AFFILIATES), merger or reorganization of PROTALIX or any of its AFFILIATES, or a sale
                                         or other transfer by PROTALIX or any of its AFFILIATES of all or substantially all of
                                         the assets or business to which this AGREEMENT relates. Subject to the foregoing, this
                                         AGREEMENT shall be binding upon and inure to the benefit of the PARTIES and their successors,
                                         respective heirs, and legal representatives. Any purported assignment in violation of
                                         this Article 20.6 shall be void ab initio. Any permitted assignee shall assume
                                         all obligations of its assignor under this AGREEMENT. Notwithstanding the foregoing,
                                         should Bio-Manguinhos become a company controlled by FIOCRUZ (Empresa Brasileira de Biotecnologia
                                         em Saúde - Bio-Manguinhos), both parties consent that this agreement may be transferred
                                         to such company at FIOCRUZ's sole discretion without Protalix
                                         written consent.



 






    	36



    	 



    

 


		20.7	Independent
                                         Contractor. The relationship between the PARTIES is that of independent contractors.
                                         The PARTIES are not joint venturers, partners, principal and agent, employer and employee,
                                         and have no other relationship other than independent contracting parties. Neither PARTY
                                         has the authorization or right hereunder to make any representations, enter into any
                                         agreements or assume any other obligations on behalf of the other PARTY.



 


		20.8	Publicity.
                                         FIOCRUZ shall not make (and shall cause its Affiliates
                                         not to make) any press release or public statement (written or oral) concerning
                                         the terms of, or events related to, this AGREEMENT or concerning PROTALIX, the PRODUCT,
                                         COMPOUND, DRUG SUBSTANCE, SUPPLIED MATERIALS, or PROTALIX TECHNOLOGY, without the prior
                                         written approval of PROTALIX, except where such statement is required by Brazilian LAW.
                                         In the case of any press release or public statement (written or oral) that is required
                                         by Brazilian LAW, FIOCRUZ shall use all reasonable efforts to give PROTALIX sufficient
                                         advance notice of the text of any such public statement, so that PROTALIX will have the
                                         opportunity to comment upon the statement, and give due consideration to any of PROTALIX's
                                         comments on such text.



 


		20.9	Notices.
                                         All notices, consents, approvals, requests or other communications required hereunder
                                         given by one PARTY to the other hereunder shall be in writing and made by registered
                                         or certified air mail, facsimile, express overnight courier or delivered personally to
                                         the following addresses of the respective PARTIES:



 


	If
    to PROTALIX:	 	Protalix
    Ltd.
	 	 	2
    Snunit Street
	 	 	Science
    Park
	 	 	P.O.B
    455
	 	 	Carmiel
    20100, Israel
	 	 	Attention:   Chief
    Executive Officer
	 	 	Facsimile:  972-4-988-9489



 


	If to FIOCRUZ:	 	Fiocruz
	 	 	Bio-Manguinhos
	 	 	Pavilhão Rocha Lima –
    6 andar
	 	 	Avenida Brasil, 4365, Manguinhos
	 	 	Rio de Janeiro, CEP: 21040-360
	 	 	Brazil
	 	 	Attention: Bio-Manguinhos Director
	 	 	Facsimile: + 55 21 3882-7176


 


Notices
hereunder shall be deemed to be effective (a) upon receipt if personally delivered, (b) on the tenth (10th) Business
Day following the date of mailing if sent by registered or certified air mail and (c) on the first (1st) Business
Day following the date of transmission or delivery to the overnight courier if sent by facsimile or overnight courier.
A PARTY may change its address listed above by sending notice to the other PARTY in accordance with this Article 20.9.


 


		20.10	Third
                                         Party Beneficiaries. Except for the rights of PERSONS not a PARTY to this AGREEMENT
                                         to indemnification pursuant to Article 16 (which is intended to benefit such PERSONS),
                                         none of the provisions of this AGREEMENT shall be for the benefit of or enforceable by
                                         any Third PARTY, including any creditor
                                         of any PARTY. No Third PARTY shall obtain
                                         any right under any provision of this AGREEMENT or shall by reason of any such provision
                                         make any claim in respect of any debt, liability or obligation (or otherwise) against
                                         any PARTY.



 






    	37



    	 



    

 


		20.11	Subcontractors.
                                         FIOCRUZ shall not use any subcontractors to perform its obligations or exercise its rights
                                         hereunder, without the prior written consent of PROTALIX. PROTALIX may use one or more
                                         of its Affiliates or any reasonably able
                                         Third PARTIES to exercise its rights or
                                         perform its obligations hereunder (including each other). Despite any such subcontracting
                                         the PARTIES shall remain liable hereunder for the performance of all of its obligations
                                         hereunder (including the payment of any amounts due hereunder).



 


		20.12	Headings.
                                         Headings in this AGREEMENT are included herein for ease of reference only and shall have
                                         no legal effect.



 


		20.13	Language.
                                         This AGREEMENT has been prepared in the English language and has been translated
                                         into the Portuguese language and the Portuguese language version shall control all questions
                                         of interpretation and performance hereof. If there is any difference in meaning between
                                         any portion of the English version and any other version, the Portuguese version shall
                                         prevail. Unless otherwise specifically required by Brazilian LAW or by written agreement
                                         of the PARTIES or as otherwise provided herein, all notices and other communications
                                         required or permitted under this AGREEMENT shall be made in the English language.



 


[Signature
Page Follows]


 




    	38



    	 



    

 


IN
WITNESS WHEREOF the PARTIES hereto have caused this AGREEMENT to be executed by their duly authorized officers upon the date set
out below.


 


	Fundação
    Oswaldo Cruz
	(on behalf of itself
    and the Immunobiological
	 Technology Institute
    (Bio-Manguinhos))
	 	 	 
	By:	/s/ Paulo
    Gadelha	 
	 	 	 
	Name:  	Paulo Gadelha	 
	Title:	President	 
	 	 	 
	Date:  	 	 
	 	 	 
	Protalix Ltd.	 
	 	 	 
	By: 	/s/ David
    Aviezer	 
	 	 	 
	Name: 	David Aviezer	 
	Title:	President and CEO	 
	 	 	 
	Date:  	 	 


  


[Signature
Page to Technology Transfer and Supply Agreement] 


 




    	39



    	 



    

 


APPENDIX
I


 


PROTALIX
TECHNOLOGY (INCLUDING SPECIFICATIONS)


 


[***]


 




    	[Appendix I]



    	 



    

 


 


APPENDIX
II


 


TECHNOLOGY
TRANSFER


[***]


 




    	[Appendix II]



    	 



    

 


APPENDIX
III


 


FORM
OF ACCEPTANCE CERTIFICATE


 


ACCEPTANCE
CERTIFICATE


 


[DATE]


 


RE:Completion
of Technology Transfer Stage [#]


 


Reference
is hereby made to the Technology Transfer Agreement by and between PROTALIX LTD., a limited liability company incorporated under
the laws of Israel with offices located at 2 Snunit Street, Science Park, P.O.B 455, Carmiel 20100, Israel (“Protalix”)
and FUNDAÇÃO OSWALDO CRUZ, an agency of the Brazilian Ministry of Health organized under the laws of Brazil, including
its manufacturing unit “BIO-MANGUINHOS”, with registered offices at Avenida Brasil, 4365, Manguinhos, Rio de Janeiro,
RJ, Cep 21045-900, Brazil, CGC NI 33.781.055/0001-35 (the “Agreement”). All capitalized terms contained herein shall
have the meaning ascribed to such terms in the Agreement. Pursuant to the Agreement, PROTALIX and FIOCRUZ hereby acknowledge and
agree that (i) the COMPLETION REQUIREMENTS of STAGE [X] of the TECHNOLOGY TRANSFER have been achieved, (ii) PROTALIX has fulfilled
its obligations with respect to STAGE [X], including the TECHNOLOGY TRANSFER, supply of the SUPPLIED MATERIALS, and any technical
assistance and training for such STAGE, and (iii) STAGE [X] is now complete and the Parties can proceed to STAGE [X+1].


 


	PROTALIX
    LTD.	FUNDAÇÃO
    OSWALDO CRUZ
	 	 
	By:  	By:
     
	Print
    Name:	Print
    Name:  
	Date:	Date:


  




    	[Appendix III]



    	 



    

 


APPENDIX
IV – PURCHASE ORDER


 


[***]


 




    	[Appendix IV]



    	 



    

 


APPENDIX
V


 


PFIZER
APPROVAL


To



Agência
Nacional de Vigilância Sanitária (ANVISA/MS)


 


DECLARATION
OF IMPORT AUTHORIZATION


BY
LEGAL ENTITY WHICH DOES NOT HOLD REGULARIZATION BEFORE ANVISA


(Legal
Basis: RDC No 81/08 – CHAPTER VII – ITEM 7B)


 


REFERENCE:
Import License/IL no _____/_________________-________


 


The
company Laboratórios PFIZER Ltda., with (address), duly regularized before ANVISA – Agência Nacional de Vigilância
Sanitária under No ___________, represented by its Legal Representative ______________________________ and Legal Responsible
______________________________, and by its Technical Responsible _______________________________, undersigned, grants authorization
to import, directly from its supplier Protalix Ltd., the product indicated below, and which holds the regularization document
before Ministério da Saúde/Agência Nacional de Vigilância Sanitária.


 


	Authorized
    Importer:	Fiocruz
                                         – Instituto de Tecnologia em Imunobiológicos, Bio-Manguinhos

         

        CNPJ
        no 33.781.055/0015-30

         



 


	Description
    of the health product:	Registration
    no at ANVISA	Term
	____________________________________

         

         

         
	_________________________	________________


In
compliance with the determination of RDC no 81/08, we authorize exclusively the importer mentioned above to use the abovementioned
register, and, therefore, its transfer is prohibited.


 


We
expressly assume the commitment to and compliance with the standards and procedures of health legislation, as well as the science
of the penalties to which we will be subject, pursuant to Law No. 6437, August 1977.


 


Legal
Representative: ___________________


 


Legal
Responsible:___________________


 


Technical
Responsible: ___________________


 


Valid
for 90 days from issuance


 


Rio
de Janeiro, __________________________.


  


	 	 	 
	Legal Representative
    	 	Legal Responsible










_____________________________


Technical
Responsible




    	[Appendix V]



    	 



    

 


APPENDIX
VI - LETTER OF CREDIT


 


[***]


 




    	[Appendix VI]



    	 



    

 


APPENDIX
VII


 


ACCOUNT
INFORMATION


 


[***]


 




    	[Appendix VII]



    	 



    

 


APPENDIX
VIII


PHARMACOVIGILANCE
AGREEMENT


 


[***]


 




    	[Appendix VIII]



    	 



    

  


EXHIBIT
A


 


AMINO
ACID SEQUENCE FOR DRUG SUBSTANCE


 


	 	EFARPCIPKS	FGYSSVVCVC	NATYCDSFDP	PTFPALGTFS	RYESTRSGRR	MELSMGPIQA
	61	NHTGTGLLLT	LQPEQKFQKV	KGFGGAMTDA	AALNILALSP	PAQNLLLKSY	FSEEGIGYNI
	121	IRVPMASCDF	SIRTYTYADT	PDDFQLHNFS	LPEEDTKLKI	PLIHRALQLA	QRPVSLLASP
	181	WTSPTWLKTN	GAVNGKGSLK	GQPGDIYHQT	WARYFVKFLD	AYAEHKLQFW	AVTAENEPSA
	241	GLLSGYPFQC	LGFTPEHQRD	FIARDLGPTL	ANSTHHNVRL	LMLDDQRLLL	PHWAKVVLTD
	301	PEAAKYVHGI	AVHWYLDFLA	PAKATLGETH	RLFPNTMLFA	SEACVGSKFW	EQSVRLGSWD
	361	RGMQYSHSII	TNLLYHVVGW	TDWNLALNPE	GGPNWVRNFV	DSPIIVDITK	DTFYKQPMFY
	421	HLGHFSKFIP	EGSQRVGLVA	SQKNDLDAVA	LMHPDGSAVV	VVLNRSSKDV	PLTIKDPAVG
	481	FLETISPGYS	IHTYLWHRQD	LLVDTM	 	 	 


 




    	[Exhibit A]



    	 



    

 


EXHIBIT
B


 


PROTALIX
PATENT SCHEDULE


 


[***]


 




    	 



    	 



    

 


EXHIBIT
C


 


APPLICABLE
TAXES AND FEES


 


A
[***]% tax will be withheld from payments for services made by FIOCRUZ pursuant to Section 7.4.5.


 


There
are no withholding or other taxes applicable to any payments required to be made by FIOCRUZ under this AGREEMENT, including those
made for the purchase of PRODUCTS during each STAGE of the TECHNOLOGY TRANSFER.