Exhibit
10.44


 


INDEPENDENT
RESEARCH FUNDING AGREEMENT


 


This
Independent Research Funding Agreement
(this “Agreement”) is made this
15 day of July, 2020 (the “Effective
Date”) by and between: Biosight Ltd. (hereinafter referred to as “COMPANY”), address 3 Ha’yarden St., Airport
City, Israel; and GFM (Groupe
Francophone des MyélodysplasiES (hereinafter referred to as “INSTITUTION”), located at Service d’HématologieSéniors,
Hôpital Saint Louis/ Université Paris 7, 1 avenue Claude Vellefaux/ 75010 Paris, France.


 


WHEREAS,
COMPANY has agreed to provide funding and support to INSTITUTION and its employee Prof Pierre FENAUX (“Principal Investigator”)
to conduct an independent clinical trial
according to a protocol and any related
amendments (the “Protocol”) entitled “A Phase 2, Open-Label, Single Arm,
Multi-Center Study to Assess the Efficacy and Safety of BST-236 as a
Single Agent in Adults Unfit for Intensive Chemotherapy with Relapse or Refractory Acute Myelocytic
Leukemia or Higher-Risk Myelodysplastic Syndrome”
(the “Study”), attached hereto as Exhibit A and incorporated herein by reference.


 


WHEREAS,
INSTITUTION is equipped to undertake the Study under its own responsibility and under the direction of PRINCIPAL INVESTIGATOR and INSTITUTION
and PRINCIPAL INVESTIGATOR have agreed to perform the Study as set forth in the Protocol and on the terms and conditions hereinafter
set forth.


 


WHEREAS,
COMPANY, INSTITUTION, and PRINCIPAL INVESTIGATOR are interested in the expansion and dissemination of scientific knowledge.


 


WHEREAS,
COMPANY, as a condition for the funding and support of the Study, desires to bind, and INSTITUTION and PRINCIPAL INVESTIGATOR agree to
be bound to the conditions of support identified herein.


 


NOW,
THEREFORE, in consideration of the premises and the mutual promises and covenants expressed herein, the parties agree as follows:


 


	1.	Performance of Study






 


	1.1	INSTITUTION
                                            and PRINCIPAL INVESTIGATOR agree to use their best efforts
                                            and professional expertise to perform the Study in accordance
                                            with the Protocol, all applicable legal and regulatory requirements, all written instructions
                                            and guidelines provided by the Company from time to time, including without limitation with
                                            respect to the storage, handling, use, administration and disposal of the Study Product,
                                            and in accordance with the terms and conditions of this Agreement. If
                                            INSTITUTION and/or PRINCIPAL INVESTIGATOR wish to modify
                                            the Protocol in any material respect, INSTITUTION and
                                            PRINCIPAL INVESTIGATOR shall notify COMPANY in advance of any such changes in writing. If
                                            these changes will affect the cost of the Study
                                            to be borne by COMPANY, INSTITUTION will submit to COMPANY a written estimate of such change
                                            in Study cost. COMPANY’s prior review and, in its sole discretion, acceptance of any
                                            such changes shall be required prior to implementation, and the status quo shall persist
                                            with respect to such matter until COMPANY’s consent
                                            is granted.



 


	1.2	The
                                            INSTITUTION and PRINCIPAL INVESTIGATOR retain the sole and complete regulatory responsibility
                                            as the “sponsor” of the Study (in accordance with Art. 2 (e)
                                            of the 2001/20/EG guideline) and /or as defined at 21 CFR 312 and in
                                            guidance published by the Food and Drug Administration
                                            (“FDA”) and foreign equivalents, including
                                            for all purposes of this Agreement, all cognizant national, state and provincial drug and
                                            health regulatory agencies). Neither INSTITUTION nor PRINCIPAL INVESTIGATOR shall represent
                                            to any third party, including participants enrolled in the Study (“Subjects”),
                                            that COMPANY is a Study sponsor. Except for the funding
                                            and the Study Product to be provided by COMPANY under this Agreement, the PRINCIPAL INVESTIGATOR
                                            and/or INSTITUTION are responsible for providing, at their own expense, all facilities, personnel,
                                            equipment, tools and other supplies necessary to perform the Study under this Agreement and
                                            in accordance with the Protocol. Any funding provided by COMPANY may not be used to compensate
                                            anyone, including physicians, for referring potential Subjects for enrollment in the Study.



 




    	 



     


    




 


	1.3	INSTITUTION
                                            and PRINCIPAL INVESTIGATOR certify that they have secured or will secure, if required, a
                                            Clinical Trial Application (CTA) as well as any other required regulatory authorizations,
                                            prior to enrolling Subjects in the Study. If a CTA or equivalent is required, the PRINCIPAL
                                            INVESTIGATOR agrees to supply COMPANY with a copy of the respective Health Authority letter
                                            that assigns the PRINCIPAL INVESTIGATOR a study/application number. For studies conducted
                                            outside the United States, PRINCIPAL INVESTIGATOR agrees to supply COMPANY with a copy of
                                            the letter authorizing the clinical trial. The COMPANY shall submit the Investigational Medicinal
                                            Product Dossier in connection with the Study to the regulator.



 


	1.4	In
                                            the event that the PRINCIPAL INVESTIGATOR ceases to be affiliated with INSTITUTION or becomes
                                            unwilling or unable to perform the duties required by this Agreement, INSTITUTION shall provide
                                            written notice to COMPANY within three (3) days of such change. In such event, INSTITUTION
                                            will designate a new PRINCIPAL INVESTIGATOR. COMPANY shall have the right to approve any
                                            new PRINCIPAL INVESTIGATOR designated by INSTITUTION. The new PRINCIPAL INVESTIGATOR shall
                                            be required to agree to the terms and conditions of this Agreement. In the event COMPANY
                                            does not approve such new PRINCIPAL INVESTIGATOR, COMPANY may terminate this Agreement in
                                            accordance with Section 14.2 below, without any cost to COMPANY, and INSTITUTION shall take
                                            all necessary steps to accommodate COMPANY’s decision.



 


	1.5	INSTITUTION
                                            and PRINCIPAL INVESTIGATOR represent and certify to COMPANY that each maintains, and shall
                                            maintain throughout the Term of this Agreement, all necessary authorization to enter into
                                            this Agreement, shall obtain all necessary institutional approvals prior to the start of
                                            the Study, and that the terms and conditions of this Agreement do not conflict with the institutional
                                            policies or any agreement to which INSTITUTION or PRINCIPAL INVESTIGATOR is a party.



 


	1.6	PRINCIPAL
                                            INVESTIGATOR shall provide COMPANY with Study updates (e.g., enrollment, timelines) on no
                                            less than a quarterly basis in a form reasonably acceptable to, and containing such information
                                            reasonably requested by, COMPANY.



 


	1.7	INSTITUTION
                                            agrees that each site involved in this Study shall, prior to beginning the Study, enter into
                                            an agreement with INSTITUTION regarding its participation in the Study. Each such agreement
                                            shall be directly entered into by the applicable site and INSTITUTION, shall be consistent
                                            with the terms of this Agreement, and shall include, without limitation and to the extent
                                            applicable, terms at least as protective of COMPANY’s rights as those set forth in
                                            this Agreement. All Study sites shall be subject to COMPANY’s approval in writing;
                                            provided that COMPANY shall have no obligation to inspect such sites prior to approval.



 


	1.8	No
                                            party shall perform any actions that are prohibited by local and other anti-corruption laws,
                                            including but not limited to the U.S. Foreign Corrupt Practices Act and substantive provisions
                                            of applicable anti-bribery legislation (collectively, “Anti-Corruption Laws”)
                                            that may be applicable. Without limiting the foregoing, no party shall make any payments,
                                            or offer or transfer anything of value, to any government official or government employee,
                                            to any political party official or candidate for political office or to any other third party
                                            related to the transaction in a manner that would violate Anti-Corruption Laws.



 




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	1.9	PRINCIPAL
                                            INVESTIGATOR shall conduct the Study in a manner conforming a reasonable and prudent clinical
                                            investigator or physician. The Study will be conducted in an efficient, diligent, professional
                                            and timely manner, and in accordance with all applicable standards, regulations and guidelines
                                            for good clinical practice (“GCP”) and ethical conduct in connection with
                                            clinical studies and/or medical devices, including the World Medical Association Declaration
                                            of Helsinki entitled “Ethical Principles for Medical Research Involving Human Subjects”,
                                            and the provisions of the current ICH Harmonized Tripartite Guideline for Good Clinical Practice
                                            (ICH-GCP) and ISO 14155.
	 	 
	2.	Ethics
                                            Committee (“EC”) - Informed Consent - Authorizations



 


	2.1	In
                                            accordance with the laws and regulations applicable at the Study site(s), INSTITUTION and
                                            PRINCIPAL INVESTIGATOR shall be responsible for obtaining approval of the Protocol and its
                                            amendments (subject to Section 1.1 above), forms evidencing informed consent of all Subjects
                                            (or their legally authorized representatives) participating in the Study (each, an “Informed
                                            Consent Form”), Study recruitment procedures (e.g. advertisements, financial compensation)
                                            and any other relevant documents in connection with the Study, from the appropriate EC prior
                                            to commencement of the Study. For the sake of clarity, it is agreed and understood that the
                                            commencement of the Study is subject to the receipt of approval from the appropriate EC at
                                            each Study site. Each of the INSTITUTION and the PRINCIPAL INVESTIGATOR shall use its best
                                            efforts to obtain such approval as soon as possible. In the event the EC requires changes
                                            in, or the INSTITUTION and/or PRINCIPAL INVESTIGATOR intend to change, the Informed Consent
                                            Form, such changes shall be submitted to COMPANY prior to implementation. INSTITUTION and
                                            PRINCIPAL INVESTIGATOR shall be responsible for fulfilling all other authorization formalities
                                            related to the conduct of the Study (such as submitting a clinical trial application as described
                                            in Section 1 above) and if required, for obtaining the written authorization from any regulatory
                                            body with competent jurisdiction over the conduct of the Study (each, a “Health Authority”
                                            and collectively, the “Health Authorities”) prior to commencement of the Study.
                                            INSTITUTION, on behalf of itself and the PRINCIPAL INVESTIGATOR, shall provide COMPANY with
                                            a copy of these authorizations. The PRINCIPAL INVESTIGATOR shall comply with all the requirements
                                            of the relevant EC and shall execute such assurances and other documents as such EC may request,
                                            a copy of which shall be provided to COMPANY. While COMPANY will make itself available to
                                            the extent necessary, and provide feedback to the extent requested, to facilitate any such
                                            filings with Health Authorities, all submission obligations shall remain on INSTITUTION and
                                            PRINCIPAL INVESTIGATOR, and INSTITUTION shall ensure notice of any such submissions is provided
                                            to COMPANY at least thirty (30) days prior to submission.



 


	2.2	INSTITUTION
                                            and PRINCIPAL INVESTIGATOR shall be responsible for ensuring that the Informed Consent Form
                                            is signed by or legally on behalf of each Subject before participation in the Study. This
                                            informed consent document shall be the document approved by each of the Study sites’
                                            related ECs and the COMPANY, prior to the Subject’s participation in the Study. INSTITUTION
                                            and PRINCIPAL INVESTIGATOR agree to include elements (i.e., risk language) in the Informed
                                            Consent Form that COMPANY considers materially relevant in light of its special knowledge
                                            of its Medical Affairs group with respect to the “Study Product”. INSTITUTION
                                            and PRINCIPAL INVESTIGATOR further agree to maintain such approval until the completion of
                                            the Study, and re-obtain EC approval at any additional time intervals required by law or
                                            by INSTITUTION’s or EC’s policy. INSTITUTION and PRINCIPAL INVESTIGATOR will
                                            notify COMPANY promptly of any withdrawal or suspension of EC approval during the Term of
                                            this Agreement.



 


	2.3	If
                                            requested by the COMPANY, INSTITUTION and PRINCIPAL INVESTIGATOR shall provide COMPANY with
                                            a copy of the letter of approval from each EC, the approved Informed Consent Form, any approved
                                            modified version thereof, and any relevant communications with each EC, which includes but
                                            is not limited to information which may affect the conduct of the Study.


 




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	3.	Adverse
    Event Reporting and Product Quality Complaints



 


	3.1	As
                                            the sponsor of the Study, the INSTITUTION and PRINCIPAL INVESTIGATOR shall be solely responsible
                                            for complying, within the required timelines, with any safety reporting obligation towards
                                            the competent Health Authorities, the ECs and the participating (co- or sub-) investigators,
                                            as defined in the applicable laws and regulations.



 


	3.2	PRINCIPAL
                                            INVESTIGATOR and INSTITUTION will promptly (within one (1) business day) provide COMPANY
                                            or its designee with a copy of all serious adverse event reports, deaths and pregnancies
                                            related to the Study and/or the Study Product as more fully set forth in Exhibit B
                                            to this Agreement. In addition, PRINCIPAL INVESTIGATOR and INSTITUTION agree to follow up
                                            on safety information and promptly forward (within one (1) business
                                            day) to COMPANY any written, verbal, or electronic reports of suspected quality defect in
                                            the Study Product (or manufacture of the Study Product) or its COMPANY-provided packaging
                                            or labeling (including, but not limited to, actual or suspected product tampering, contamination,
                                            or mislabeling) (“Product Quality Complaints”) within one (1) business day of
                                            PRINCIPAL INVESTIGATOR’s or INSTITUTION’s knowledge of the same. Product Quality
                                            Complaints shall be communicated to COMPANY at the following email address: liat@biosight-pharma.com



 


	3.3	INSTITUTION
                                            and PRINCIPAL INVESTIGATOR agree to immediately update the Protocol and Informed Consent
                                            Form at the request of COMPANY for safety-related reasons. In the event of an adverse event
                                            or Product Quality Complaint, INSTITUTION and PRINCIPAL INVESTIGATOR shall provide COMPANY
                                            with all assistance and shall promptly take all measures as COMPANY may reasonably require.
	 	 
	4.	Monitoring
                                            - Audit/Inspection



 


	4.1	INSTITUTION
                                            and PRINCIPAL INVESTIGATOR agree that as sponsor of the Study they are solely responsible
                                            for the monitoring of the Study in compliance with good clinical practices (“GCP”)
                                            and in accordance with the monitoring oversight plan attached hereto as Exhibit D.



 


	4.2	During
                                            the Term of this Agreement, INSTITUTION and PRINCIPAL INVESTIGATOR agree to permit representatives
                                            of COMPANY (with at least five (5) days’ notice), and/or any Health Authority, to examine
                                            at any reasonable time during normal business hours: (a) the facilities where the Study is
                                            being conducted; and (b) any relevant information, to the extent permitted by applicable
                                            laws and regulations, reasonably necessary to confirm that the Study Product is being used
                                            and administered consistent with the Protocol and in compliance with applicable laws and
                                            regulations and in conformance with the terms of this Agreement, to validate case reports
                                            against original data, and to make copies of such data, documents and records, and to monitor
                                            work performed, to ensure its compliance with the Study Protocol, applicable laws, regulations,
                                            guidelines and the terms of this Agreement. INSTITUTION and PRINCIPAL INVESTIGATOR shall
                                            immediately notify COMPANY if a competent Health Authority schedules or, without scheduling,
                                            begins an inspection of the site during the Term of this Agreement and for a period of five
                                            (5) years thereafter, and shall promptly provide COMPANY with a copy of correspondences,
                                            notices and any other documents and observations provided by or to such Health Authority
                                            relating to the Study and/or resulting from any such inspection.



 


	4.3	INSTITUTION
                                            and PRINCIPAL INVESTIGATOR agree to take any reasonable actions requested by COMPANY to cure
                                            deficiencies noted during an audit or inspection performed by the COMPANY or a Health Authority.



 




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	5.	Study
    Product



 


	5.1	As
                                            part of the support provided by the COMPANY, COMPANY will provide to designated depos in
                                            Europe BST-236 (the “Study Product”) in quantities to support the Protocol free
                                            of charge for eligible Subjects who are enrolled in the Study until such time as they complete
                                            the Study in accordance with the Protocol or the Study is otherwise terminated. This amount
                                            excludes any Study Product replaced due to either expiry dating, recall or damage, unless
                                            such expiration, recall or damage is attributable to any action or inaction taken by the
                                            INSTITUTION, PRINCIPAL INVESTIGATOR, or Study personnel. Not otherwise limiting the foregoing,
                                            INSTITUTION shall use reasonable efforts to provide COMPANY with a quarterly demand forecast
                                            for bulk planning purposes. INSTITUTION and PRINCIPAL INVESTIGATOR shall not order or collect
                                            from the designated depos in Europe quantity of the Study Product that exceeds the quantity
                                            actually required for the enrolled eligible Subjects under the Protocol.



 


	5.2	COMPANY
                                            will also provide, to the extent applicable, reasonable support to INSTITUTION and PRINCIPAL
                                            INVESTIGATOR to enable them to comply with their sponsor’s duties related to the manufacturing,
                                            supplying and quality of the Study Product (including those described in the International
                                            Conference on Harmonization Guidelines for Good Manufacturing Practices (“ICH GMPs”))
                                            and related information to be submitted to the competent Health Authorities. If COMPANY initiates
                                            a recall, INSTITUTION and PRINCIPAL INVESTIGATOR shall comply with this recall.



 


		5.2.1.	COMPANY
                                            and INSTITUTION shall promptly provide each other with any data or information in their possession
                                            (e.g., defective packaging material) that could result in a recall of the Study Product.



 


		5.2.2.	In
                                            the event of a potential or actual recall of Study Product already delivered to INSTITUTION
                                            or its designee, COMPANY and INSTITUTION shall consult and cooperate on any recall decision
                                            with the aim of reaching an agreement. COMPANY shall be responsible for the final recall
                                            decision for such Study Product and the INSTITUTION shall be responsible for any resulting
                                            communication with third parties.



 


	5.3	COMPANY
                                            declares and warrants that the Study Product will be manufactured and controlled in compliance
                                            with the ICH GMPs. Notwithstanding anything herein to the contrary, COMPANY shall be entitled
                                            to subcontract the packaging, labeling, testing, release and delivery of Study Product, whether
                                            in whole or in part, to the third-party contractors which have been approved for use by the
                                            COMPANY. COMPANY will provide INSTITUTION and PRINCIPAL INVESTIGATOR written notification
                                            of required actions due to stability or other testing results for each lot provided. Upon
                                            Company’s request, the parties shall enter into a separate Quality Agreement with respect
                                            to use of the Study Product by INSTITUTION and PRINCIPAL INVESTIGATOR in the Study.



 


	5.4	All
                                            Study Product supplied to INSTITUTION will remain the exclusive property of COMPANY until
                                            administered to Subjects in accordance with Protocol requirements.



 




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	5.5	INSTITUTION
                                            and PRINCIPAL INVESTIGATOR shall be responsible for complete Study Product accountability
                                            and monitoring in accordance with good clinical practices, ICH GCPs (as applicable), the
                                            terms of this Agreement, the Protocol, and applicable law, and agree that Study Product provided
                                            by COMPANY under the terms of this Agreement shall be used only for this Study and enrolled
                                            Subjects. INSTITUTION shall ensure that Study Product is study-specific labeled and appropriately
                                            released prior to being given to any Subject. INSTITUTION shall ensure, and shall maintain
                                            appropriate records reflecting, that Study Product will be stored (in a secure and locked
                                            location to prevent theft or misuse), handled, accurately inventoried, administered to Subjects,
                                            distributed to participating sites, and destroyed or returned to depot in accordance with
                                            GCP, the terms of this Agreement, the Protocol, any instruction provided by COMPANY in writing,
                                            and all applicable law, administered only to Study Subjects, and that no expired Study Product
                                            will be given to any Subject in this Study. At the conclusion or termination of this Study,
                                            INSTITUTION shall ensure that all unused Study Product across all sites is promptly returned
                                            to COMPANY or its designee, or otherwise promptly disposed of, in accordance with COMPANY’s
                                            instructions and following COMPANY’s written approval. INSTITUTION will provide COMPANY
                                            with documentation of Study Product’s destruction. After completion or termination
                                            of the Study, whichever is earlier, INSTITUTION shall account for all quantities used of
                                            the Study Product.



 


	5.6	If
                                            any quantity of Study Product is, in the reasonable judgment of INSTITUTION, defective due
                                            to improper storage, shipping, or handling after being correctly dispatched or expires due
                                            to recruitment delays not otherwise contemplated by the recruitment schedule of the Protocol
                                            (collectively, “Defective Product”), INSTITUTION and PRINCIPAL INVESTIGATOR will
                                            not use the Defective Product in the Study, and will arrange at no additional cost to COMPANY,
                                            at Company’s option, to either (i) return the Defective Product to Company, or (ii)
                                            for the prompt destruction of all Defective Product. INSTITUTION will provide COMPANY with
                                            documentation of such Defective Product’s destruction.



 


	5.7	If
                                            the INSTITUTION or PRINCIPAL INVESTIGATOR becomes aware during the conduct of the Study of
                                            any of the following information or circumstances relating to the Study Product, PRINCIPAL
                                            INVESTIGATOR will promptly notify COMPANY: (a) imposition by an applicable competent regulatory
                                            authority in any area of the world in which the Study Product is marketed of any prohibition
                                            or restriction of the Study Product’s use; or (b) any new information that might influence
                                            the evaluation of the risks and benefits of the Study Product (e.g., either positive or negative
                                            results from clinical trials or other studies in relation to
                                            all indications and populations, whether or not use of the Study Product in that indication
                                            or population is approved under the relevant marketing authorization). PRINCIPAL INVESTIGATOR
                                            is to provide such notification to COMPANY promptly upon becoming aware of such information
                                            or circumstances, even if complete information is not yet available.



 


	5.8	INSTITUTION
                                            and PRINCIPAL INVESTIGATOR will not submit bills to third party payment programs for the
                                            distribution or use of the free Study Product supplied by COMPANY in good faith solely for
                                            the use of Subjects enrolled in the Study, nor will INSTITUTION and/or PRINCIPAL INVESTIGATOR
                                            bill third party programs for the services rendered to administer Study Product to Study
                                            Subjects.
	 	 
	6.	Funding



 


	6.1	The
                                            total funding budget which COMPANY has agreed to provide to INSTITUTION and PRINCIPAL INVESTIGATOR
                                            to support the Study with the number of patients specified in the Protocol is as set forth
                                            in the Funding Budget attached hereto as Exhibit C and incorporated herein
                                            by reference. Parties acknowledges that the Company shall pay the fees specified in Exhibit
                                            C only in connection with Study Subjects who were actually enrolled to the Study
                                            and were treated with the Study Product at least one day in accordance with the provisions
                                            of the Protocol. Any and all sums due to other sites involved in the Study shall be paid
                                            by INSTITUTION from the total budget specified in Exhibit C, as may be amended
                                            in writing executed by both parties.



 




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The
payments will be transferred to the following account of the INSTITUTION:


 


Bank
name: ***


Full
address: ***


Number:
***


Beneficiary
: ***


SWIFT
/BIC code : ***


IBAN
code : ***


 


	6.2	The
                                            INSTITUTION and PRINCIPAL INVESTIGATOR assure and guarantee that the payments will be used
                                            only for the conduct of the Study in accordance with Exhibit C. The correct
                                            payment of taxes is to be ensured by the INSTITUTION and PRINCIPAL INVESTIGATOR. Payments
                                            are made as net payments. If any VAT is due on any Study Product, COMPANY will also pay VAT
                                            after receipt of a detailed invoice.



 


	6.3	An
                                            invoice shall be provided to COMPANY for each installment due. Payments will be made within
                                            forty five (45) days as of the end of the calendar month in which a valid invoice was provided
                                            to the COMPANY by INSTITUTION. INSTITUTION shall provide COMPANY with a receipt for each
                                            installment.



 


	6.4	If
                                            COMPANY is required by applicable law to make any tax deduction, tax withholding or similar
                                            payment from any amount paid or payable by COMPANY under this Agreement, then COMPANY shall
                                            deduct such amount from the payment due to INSTITUTION as prescribed by applicable law, unless
                                            INSTITUTION provides COMPANY with evidence of an exemption from the payment thereof.



 


	6.5	The
                                            consideration set forth in Exhibit C hereto constitutes the sole and exclusive
                                            consideration payable by COMPANY for the conduct of the Study. The parties acknowledge and
                                            agree that the funding and support (including Study Product) provided by COMPANY to INSTITUTION
                                            and PRINCIPAL INVESTIGATOR pursuant to this Agreement represents a fair market value, has
                                            been negotiated in an arms-length transaction, and has not been determined in a manner that
                                            takes into account the volume or value of any referrals or other business otherwise generated
                                            between the parties and shall not obligate INSTITUTION and/or
                                            PRINCIPAL INVESTIGATOR to purchase, use, recommend or arrange for the use of any product
                                            of the COMPANY.



 


	7.	Records;
                                            Reporting of Study Progress



 


	7.1	Each
                                            of INSTITUTION and PRINCIPAL INVESTIGATOR shall: (i) prepare and maintain complete and accurate
                                            written records, accounts, notes, reports and data of the Study and the use and handling
                                            of the Study Product, including source data and case report forms in accordance with the
                                            Study Protocol and applicable laws, regulations and guidelines; and (ii) retain all such
                                            records, reports and data after completion of the Study for such periods as determined by
                                            any applicable law or regulation, but no less than fifteen (15) years, at no additional cost
                                            to COMPANY.



 


	7.2	During
                                            the term of this Agreement, PRINCIPAL INVESTIGATOR shall meet with the representatives of
                                            COMPANY, during customary working hours and to a reasonable extent, in order to report to
                                            COMPANY, on an ongoing and consecutive basis, and in order to update COMPANY in all matters
                                            related to the performance of the Study.



 


	7.3	INSTITUTION
                                            and PRINCIPAL INVESTIGATOR shall report to COMPANY in writing the results and status of its
                                            research under this Agreement on a quarterly basis in a form and with such detail reasonably
                                            required by COMPANY, and shall issue a final Study report, in a form acceptable to COMPANY,
                                            which shall, at a minimum, include a full summary of safety and efficacy information from
                                            the Study, within ninety (90) days following: (a) completion of the Study; or (b) termination
                                            of this Agreement. Reports issued hereunder shall be sent to: liat@biosight-pharma.com



 




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	8.	Compliance
                                            with Applicable Laws
	 	 
	8.1	INSTITUTION
                                            and PRINCIPAL INVESTIGATOR, being the sponsor, will conduct the Study and maintain records
                                            and data during and after the Term of this Agreement in compliance with all applicable legal
                                            and regulatory requirements,( including but not limited to the U.S. federal Food, Drug and
                                            Cosmetic Act, as amended by the U.S. Food and Drug Administration Amendments Act of 2007,
                                            21 U.S.C. §301 et seq. and regulations thereunder, all applicable U.S. IND regulations,
                                            the U.S. Patient Protection and Affordable Care Act of 2010, the U.S. Controlled Substances
                                            Act, as amended, and the regulations promulgated thereunder), as well as generally accepted
                                            conventions such as the World Medical Association Declaration of Helsinki entitled “Ethical
                                            Principles for Medical Research Involving Human Subjects”, and the standards for conduct
                                            of clinical research set forth in the International Conference on Harmonization Guidelines
                                            for Good Clinical Practices (“ICH GCPs”) and ICH GMPs, to the extent applicable.



 


		8.1.1.	PRINCIPAL
                                            INVESTIGATOR may delegate duties and responsibilities to co- and sub-investigators or research
                                            staff only to the extent permitted by the regulations, and INSTITUTION shall ensure that
                                            all co- and sub-investigators to whom the PRINCIPAL INVESTIGATOR has the authority to delegate
                                            duties and responsibilities in relation to the Study and Study personnel comply will all
                                            applicable law and are bound to all applicable obligations on terms at least as restrictive
                                            as contained in this Agreement. INSTITUTION and PRINCIPAL INVESTIGATOR shall be responsible
                                            for ensuring that all co- and sub-investigators and Study personnel comply with the terms
                                            and conditions of this Agreement, and any failure by any co- or sub-investigator or Study
                                            personnel to so comply shall constitute a breach of this Agreement by INSTITUTION and PRINCIPAL
                                            INVESTIGATOR.



 


		8.1.2.	INSTITUTION
                                            and PRINCIPAL INVESTIGATOR shall maintain, and shall ensure that all Study personnel maintain,
                                            and carry out activities hereunder in compliance with, all applicable licenses, approvals,
                                            and certifications necessary for safely and properly conducting the Study under the Protocol
                                            throughout the Term of this Agreement.



 


	8.2	Each
                                            party will comply with all applicable Data Protection Legislation in relation to the performance
                                            of its obligations under this Agreement and its conduct of the Study, including applicable
                                            laws and regulations governing the transfer of data outside
                                            of the national jurisdictions in which such Data Protection Legislation is enforced. Each
                                            party promptly will notify the other parties upon receiving knowledge of any violation of
                                            such Data Protection Legislation, including any breach of Personal Data.



 


The
parties agree that each may be a data controller under the meaning of the EU General Data Protection Regulation (2016/679) (together
with any relevant implementing legislation) (“GDPR”). INSTITUTION shall ensure that all Personal Data will be processed solely
for the purpose of carrying out the Study, as well as to comply with any obligations of law or regulation, and/ or arising from the requirements
of the competent Health Authority. INSTITUTION shall ensure that all Personal Data will be processed in such manner as to protect the
integrity and confidentiality of the data and the rights of the interested parties, in compliance with adequate security and data protection
measures. The parties agree to cooperate in good faith to ensure, and INSTITUTION and PRINCIPAL INVESTIGATOR will, and shall cause all
sites and Study personnel to, ensure that Study Subjects may exercise their rights under applicable Data Protection Legislation, including,
but not limited to, rights of access, rectification and/or deletion. INSTITUTION will make all Subject disclosures required by GDPR,
and will ensure that all Study Subjects are informed that if they wish to exercise such rights, they must reach out directly to Study
staff at the relevant site, given that INSTITUTION and COMPANY will receive coded information and generally will not have access to information
that directly identifies Study Subjects. INSTITUTION also will ensure that Study Subjects are provided with contact information for Study
staff and relevant data protection authorities.


 




    	8



    	 



    

 


	 	8.2.1.	For
    the purposes of this Agreement:



 


		8.2.1.1.	“Data
                                            Protection Legislation” means any applicable national, regional or international laws,
                                            regulations, directives or guidance documents pertaining to the data protection, privacy,
                                            confidentiality or security of Personal Data, including, without limitation, the EU Data
                                            Protection Directive (96/46/EC) (together with relevant national implementing legislation)
                                            and, beginning May 25, 2018, GDPR; and Deliberation no. 2016-262 of 21 July 2016.



 


		8.2.1.2.	“Personal
                                            Data” has the meaning given by applicable laws and regulations and includes, without
                                            limitation, any information (regardless of the medium and whether alone or in combination
                                            with other available information) that identifies or relates to an identified or identifiable
                                            natural person. Key-coded data is considered Personal Data even if the holder of that data
                                            does not have access to the key that links the data to the identity of an individual.



 


	8.3	In
                                            the event that any part of this Agreement is determined to violate applicable laws and regulations
                                            the parties agree to negotiate in good faith revisions to the provision or provisions that
                                            are in violation. In the event the parties are unable to agree to new or modified terms as
                                            required to bring the entire Agreement into compliance, any party may terminate (and with
                                            respect to PRINCIPAL INVESTIGATOR, submit notice of ceasing participation in the Study such
                                            that a replacement may be found in accordance with Section 1) this Agreement on sixty (60)
                                            calendar days prior written notice to the other party.



 





	9.	Ownership
    - Use of Data - Confidentiality - Registry - Publication








 


All
case report forms, results and other data (including without limitation, written, printed, graphic, video and audio material, and information
contained in any computer database or computer readable form) created or developed during the course of the Study (the “Data”)
shall be the property of INSTITUTION and PRINCIPAL INVESTIGATOR, which may utilize the Data for its own research and educational purposes,
subject to and in accordance with applicable privacy laws and the terms of this Agreement, including without limitation the confidentiality
provisions in this Section 9, and provided that INSTITUTION and PRINCIPAL INVESTIGATOR shall not use or permit any third party to use
the Data for the commercial benefit of any third party. INSTITUTION and PRINCIPAL INVESTIGATOR hereby grant
to COMPANY an unrestricted, perpetual, irrevocable, royalty-free, fully paid-up, worldwide license to the Data (including but not limited
to an electronic copy of the Study database) to use it for any purpose it deems fit in compliance with applicable laws including without
limitation, for the purpose of Additional Studies (including without limitation, publications and/or regulatory filings related to the
Additional Studies). Provided however that Data that directly relates to, or is attributable to, required or useful for the development,
production, commercialization or use of the Study Product or COMPANY Confidential Information shall be deemed “Company Proprietary
Rights”. Company Proprietary Rights shall be the sole property of COMPANY, which may utilize the Company Proprietary Rights for
any purpose it deems fit in compliance with applicable laws. Any and all Company Proprietary Rights shall be promptly disclosed to COMPANY
but otherwise maintained in strict confidence. Each of INSTITUTION and PRINCIPAL INVESTIGATOR hereby assigns to COMPANY all Company Proprietary
Rights and upon COMPANY’s request, INSTITUTION and PRINCIPAL INVESTIGATOR shall execute any document or instrument (including,
deeds of assignment) and shall take all further acts reasonably required to transfer and/or assign all right, title and interest in and
to the Company Proprietary Rights to COMPANY and/or to perfect COMPANY’s title therein, at COMPANY’s expense. COMPANY hereby
grants to INSTITUTION a perpetual, irrevocable, royalty-free, fully paid-up, worldwide license to use the Data solely for its own noncommercial
research and educational purposes, subject to and in accordance with applicable privacy laws and the terms of this Agreement, including
without limitation the confidentiality provisions in this Section 9, and provided that INSTITUTION and PRINCIPAL INVESTIGATOR shall not
use or permit any third party to use the Data for the commercial benefit of any third party.


 




    	9



    	 



    

 


	9.1	All
                                            information concerning Study Product, or COMPANY’s operations, such as COMPANY’s
                                            patent applications, COMPANY Inventions, formulas, manufacturing processes, basic scientific
                                            data, prior clinical data and formulation information supplied by COMPANY to INSTITUTION
                                            or PRINCIPAL INVESTIGATOR or otherwise obtained or produced by INSTITUTION and/or its employees,
                                            service providers or assistants and/or the PRINCIPAL INVESTIGATOR, in connection with the
                                            Study and/or the Study Product and not previously published (the “COMPANY Confidential
                                            Information”) are considered confidential and shall remain the sole property of COMPANY.
                                            Both during and after the Term of this Agreement, INSTITUTION and PRINCIPAL INVESTIGATOR
                                            shall maintain in confidence and use only in the conduct of the Study and evaluation of its
                                            results (i) information which is identified in the preceding sentence as confidential or
                                            which a reasonable person would conclude is the confidential and proprietary property of
                                            COMPANY and which is disclosed by or on behalf of COMPANY to INSTITUTION or PRINCIPAL INVESTIGATOR,
                                            and (ii) Data which is generated as a result of this Study. The preceding obligations shall
                                            not apply to Data or information (a) which has been published through no fault of INSTITUTION
                                            or PRINCIPAL INVESTIGATOR, (b) which COMPANY agrees in writing, may be used or disclosed,
                                            (c) which is published in accordance with Section 9.3, or (d) that is developed independently
                                            at INSTITUTION by persons who had no direct or indirect access to the COMPANY Confidential
                                            Information, as shown by contemporaneous written records. All COMPANY Confidential Information
                                            shall be returned to COMPANY at the earlier of the conclusion of this Study or termination
                                            of this Agreement or upon COMPANY request.



 


	9.2	Prior
                                            to initiating enrollment, INSTITUTION and PRINCIPAL INVESTIGATOR, being the sponsor, shall,
                                            subject to the approval of the COMPANY in accordance with Section 9.2 below, register the
                                            Study in the public registry accessible for free (e.g., www.clinicaltrials.gov) in a manner
                                            that comports to prevailing editorial standards and statements (e.g., International Committee
                                            of Medical Journal Editors). Upon completion of the Study, INSTITUTION and PRINCIPAL INVESTIGATOR,
                                            being the sponsor, will seek to publish in the peer-reviewed literature the results of the
                                            Study and any background information provided by COMPANY that is necessary to include in
                                            any publication of Study results or necessary for other scholars to verify such research
                                            results, subject to the provisions of Section 9.3 below. Once published, INSTITUTION and
                                            PRINCIPAL INVESTIGATOR, being the sponsor, shall cite the publication on a clinical study
                                            results web site (e.g., www.clinicalstudyresults.org). If the results are not accepted for
                                            publication within 18 months of completion of all Study activities contemplated by the Protocol
                                            across all sites, INSTITUTION and PRINCIPAL INVESTIGATOR will post the results on a clinical
                                            study results web site (e.g., www.clinicalstudyresults.org) in the form of a clinical study
                                            report synopsis using the ICH E-3 format, subject to the provisions
                                            of Section 9.3 below. INSTITUTION and PRINCIPAL INVESTIGATOR shall provide proof of the registration
                                            and/or posting on a publicly available website. INSTITUTION and PRINCIPAL INVESTIGATOR acknowledge
                                            that COMPANY may be registered in public registries as the sponsor of Additional Studies
                                            and/or of the Study in other territories in which the COMPANY is the study sponsor.



 




    	10



    	 



    

 


	9.3	Subject
                                            to the terms of this Section 9.3, INSTITUTION and PRINCIPAL INVESTIGATOR shall be free to
                                            publish or publicly present the results of the Study and any background information provided
                                            by COMPANY that is necessary to include in any publication of Study results or necessary
                                            for other scholars to verify such research results. The release or publication by INSTITUTION
                                            or PRINCIPAL INVESTIGATOR of any publication shall be subject to the prior written consent
                                            of COMPANY. Consent granted by COMPANY in respect of any particular publication shall not
                                            be deemed to be consent to any other publication. Each publication will adequately acknowledge
                                            and appropriately reflect the contribution of the investigators, researchers and/or employees
                                            of each of COMPANY and INSTITUTION or and the source of the information included therein,
                                            in accordance with customary scientific practice. Prior to submission for publication or
                                            presentation, INSTITUTION and PRINCIPAL INVESTIGATOR will provide COMPANY with at least sixty
                                            (60) days for review of a manuscript. PRINCIPAL INVESTIGATOR, and INSTITUTION will provide
                                            at least thirty (30) days for COMPANY to review abstracts, poster presentations or other
                                            materials. COMPANY shall have the right to: (i) make recommendations or comment on any proposed
                                            publication, which comments shall be discussed by INSTITUTION or PRINCIPAL INVESTIGATOR (as
                                            the case may be) and COMPANY, in good faith and in a timely manner, and incorporated into
                                            the said publication accordingly, and (ii) to object to the proposed publication because
                                            it contains Confidential Information or other information of COMPANY for which patent protection
                                            should be sought (prior to publication)or should be held confidential. Without derogating
                                            from the COMPANY’s right to withhold its consent to a publication, upon the COMPANY’s
                                            written request(i) INSTITUTION and PRINCIPAL INVESTIGATOR will withhold such publication
                                            for up to an additional sixty (60) days to allow for filing of a patent application and (ii)
                                            if COMPANY notifies INSTITUTION or PRINCIPAL INVESTIGATOR that the proposed publication contains
                                            any COMPANY Confidential Information or patentable information and so requests, INSTITUTION
                                            or INVESTIGATOR, as applicable, shall delete such information from the publication. INSTITUTION
                                            and PRINCIPAL INVESTIGATOR warrant the compliance of all Study investigators and other personnel
                                            involved with the Study with the provisions of this paragraph. If a particular Study is part
                                            of a multicenter study, INSTITUTION and PRINCIPAL INVESTIGATOR for such Study agree that
                                            the first publication of the results of such Study shall be made in conjunction with the
                                            presentation of a joint, multicenter publication of the Study results with the investigators
                                            and the institutions from all appropriate sites contributing data, analyses and comments.
                                            However, if such a multicenter publication is not submitted within twelve (12) months after
                                            conclusion, abandonment or termination of the Study at all sites, the INSTITUTION and/or
                                            such PRINCIPAL INVESTIGATOR or investigators may seek to publish the results from each site
                                            individually in accordance with this paragraph. INSTITUTION and PRINCIPAL INVESTIGATOR acknowledge
                                            that the COMPANY (alone or in collaboration with third parties) may conduct additional studies
                                            involving the Study Product under protocols similar to the Protocol within or outside the
                                            European Union (including without limitation, in the United States of America) (“Additional
                                            Studies”). Subject to the provisions of this Section 9, INSTITUTION and PRINCIPAL
                                            INVESTIGATOR shall share with the COMPANY the entire Study database to the extent required,
                                            at the discretion of the Company, for the conduct or registration of or publications related
                                            to, the Additional Studies.



 





	10.	Materials;
    Inventions; Patents














 


	10.1	All
                                            tangible materials furnished by or on behalf of COMPANY or obtained during the conduct of
                                            the Study (collectively, together with all associated intellectual property rights, the “Materials”)
                                            will remain the exclusive property of COMPANY. INSTITUTION and PRINCIPAL INVESTIGATOR may
                                            use Materials only as necessary to conduct the Study. INSTITUTION and PRINCIPAL INVESTIGATOR
                                            will not analyze or otherwise attempt to reverse engineer any Materials except as necessary
                                            to conduct the Study and will not transfer or make the Materials available to third parties,
                                            without the prior written consent of COMPANY.



 




    	11



    	 



    

 


	10.2	“Invention”
                                            means all inventions, discoveries, know-how, and improvements, whether or not protectable
                                            under patent, copyright or other intellectual property law, resulting from the design or
                                            performance of the Study, or the use of the Study Product or the COMPANY Confidential Information.
                                            Inventions that directly relate to, or are attributable to, required or useful for the development,
                                            production, commercialization or use of the Study Product, or result from any research not
                                            authorized hereunder (a “COMPANY Invention”) shall be the sole and exclusive
                                            property of COMPANY. INSTITUTION and/or PRINCIPAL INVESTIGATOR, as applicable, hereby assigns
                                            and agrees to assign all of its respective rights, title and interest in and to COMPANY Inventions
                                            to COMPANY, including all patents, copyrights and other intellectual property and proprietary
                                            rights therein.



 


	10.3	All
                                            rights to any Invention other than a Company Invention that result of the work conducted
                                            under this Agreement in accordance with the Protocol shall be based on inventorship under
                                            European patent laws and shall be assigned to the owner of the resulting patent or patent
                                            application based on existing or executed employee or other agreements between the inventors
                                            and the INSTITUTION and/or the PRINCIPAL INVESTIGATOR. In consideration of COMPANY’s
                                            support and funding for the Study, INSTITUTION and PRINCIPAL INVESTIGATOR will grant to COMPANY
                                            a non-exclusive, perpetual, worldwide, royalty-free license with the right to sublicense,
                                            to use each such Invention and intellectual property rights therein for any lawful purpose.
                                            INSTITUTION and PRINCIPAL INVESTIGATOR shall promptly disclose to COMPANY any such Invention
                                            or discovery arising under this Agreement.



 





	11.	Debarment








 


INSTITUTION
and PRINCIPAL INVESTIGATOR shall not employ, contract with or retain any person directly or indirectly to perform services under this
Agreement if such a person: (a) is or has ever been suspended, disqualified, excluded, or debarred by a competent Health Authority (including,
if applicable, the U.S. FDA); (b) convicted of any felonies identified among the exclusion authorities listed on the U.S. Department
of Health and Human Services, Office of Inspector General (“OIG”) website, including 42 U.S.C. 1320a-7(a) http://oig.hhs.gov/fraud.asp;
or (c) has been sentenced for malpractice related to the conduct of clinical trials. Upon written request from COMPANY, INSTITUTION and
PRINCIPAL INVESTIGATOR shall, within ten (10) days, provide written confirmation that it has complied with the foregoing obligation.
This shall be an ongoing representation and warranty during the Term of this Agreement and INSTITUTION and PRINCIPAL INVESTIGATOR shall
immediately notify COMPANY of any change in the status of the representation and warranty set forth in this Section.


 





	12.	Insurance



 


INSTITUTION
and PRINCIPAL INVESTIGATOR shall secure and maintain at their own expense in full force and effect through the performance of the Study
(and following termination of the Study to cover any claims arising from the Study) general liability insurance, worker’s compensation,
employer liability insurance and professional liability insurance that contains no exclusion for products that do not have regulatory
approval or clearance, no exclusion for clinical studies, and no exclusion for bodily injury caused by or relating to clinical studies
in amounts appropriate to the conduct of the Study and in conformance with applicable legal and regulatory requirements as well as comprehensive
and professional liability insurance of reasonable policy limits. For multi-country studies or studies with several participating sites,
INSTITUTION and PRINCIPAL INVESTIGATOR shall ensure coverage for all these participating sites.


 




    	12



    	 



    

 





	13.	Indemnification



 













	13.1	INSTITUTION
                                            and PRINCIPAL INVESTIGATOR, being the sponsor, agree that neither COMPANY, nor any of its
                                            affiliates or subsidiaries, their respective officers, directors, employees, contractors
                                            or agents will bear any responsibility or liability for claims, losses, injuries, or other
                                            damages, including any consequential, incidental, special, or indirect damages (including
                                            loss of profits or business opportunity), to the extent that any of the above arises from:
                                            (i) any breach of this Agreement by INSTITUTION or PRINCIPAL INVESTIGATOR or by any of the
                                            clinical staff involved in the Study, including any failure
                                            to comply with the terms of the Study Protocol or any deviation of the study protocol or
                                            the Company’s written instructions with respect to the performance of the Study and/or
                                            use or administration of the Study Product; (ii) the failure by INSTITUTION, PRINCIPAL INVESTIGATOR
                                            and/or any of the clinical staff involved in the Study and/or any agents or contractors of
                                            Institution involved in the performance of the Study to comply with any applicable law, regulations,
                                            guidelines or other governmental requirements; (iii) the negligent, reckless or wrongful
                                            act, error or omission, willful misconduct or bad faith of INSTITUTION, PRINCIPAL INVESTIGATOR
                                            and/or any clinical staff and/or any agents or contractors of Institution involved in the
                                            performance of the Study; or (iv) any bodily injury to a third party (including a Study Subject)
                                            caused by act or omission of the INSTITUTION, PRINCIPAL INVESTIGATOR or the clinical stuff
                                            involved in the Study, and INSTITUTION and PRINCIPAL INVESTIGATOR will indemnify, defend,
                                            and hold COMPANY harmless and its respective subsidiaries and affiliates, and their respective
                                            officers, directors , employees, contractors and agents harmless from such liability. INSTITUTION
                                            and PRINCIPAL INVESTIGATOR shall not settle or compromise any claim for which COMPANY is
                                            indemnified without the prior written consent of COMPANY. COMPANY shall have no obligation
                                            of indemnification hereunder for any loss or damages arising out of the negligence or willful
                                            misconduct or failure to act of PRINCIPAL INVESTIGATOR, INSTITUTION, their officers, agents,
                                            and/or employees in connection with the conduct of the Study.



 


	13.2	The
                                            parties agree that each party shall be liable for its own negligence, willful misconduct,
                                            acts, or omissions arising out of this Agreement; provided, however, that COMPANY will not
                                            be responsible for any treatment, adverse outcomes, or other costs associated with the Subjects
                                            whether related, directly or indirectly, to the Study Product or administration of the Study
                                            Product, and will not reimburse INSTITUTION, PRINCIPAL INVESTIGATOR, or any Subjects for
                                            any cost of medical care for injury or illness directly resulting from the administration
                                            of the Study. INSTITUTION and PRINCIPAL INVESTIGATOR will inform the Subjects of the foregoing
                                            limits of COMPANY’S responsibility.
	 	 



	13.3	INSTITUTION
                                            and PRINCIPAL INVESTIGATOR understand and agree that COMPANY makes no warranty, either express
                                            or implied, regarding the use of the Study Product in the Study. Without limiting the foregoing,
                                            COMPANY expressly disclaims any implied warranties of merchantability or fitness for a particular
                                            purpose.



 





	14.	





Term
and Termination






  


	14.1	The
                                            term of this Agreement shall begin on the Effective Date stated above and end upon COMPANY’s
                                            receipt of a final Study report and written notification that the Study Data have been accepted
                                            for publication in a peer-reviewed journal or until completion of all obligations herein,
                                            or until earlier termination as herein provided (“Term”). The INSTITUTION and
                                            the PRINCIPAL INVESTIGATOR will adhere to the following timelines:
	 	 



		(i)	commencement
                                            of the Study/enrollment: 01/10/2020, but no later than six months after the Effective Date;



 




    	13



    	 



    

 


		(ii)	last
                                            Subject enrolled in the Study: 01/10/2022;



 


		(iii)	completion
                                            of final Study report for the treatment phase of the Study: no later than forty five (45)
                                            days after the last Subject completes his or her course of treatment;



 


		(iv)	completion
                                            of final Study report for the follow-up phase of the Study: 31/03/2024, but no later than
                                            six months after the last Subject’s participation in the Study ends.



 


		14.2	This
                                            Agreement may be terminated by COMPANY at any time in the exercise of its sole discretion
                                            upon fifteen (15) days prior written notice to INSTITUTION and PRINCIPAL INVESTIGATOR who
                                            immediately shall notify other Study sites of such termination. Reasons for termination of
                                            this Agreement may include but are not limited to:



 


		(i)	breach
                                            of contract, including failure to perform the Study in accordance with the terms of the Protocol,
                                            this Agreement, or applicable laws or regulations or if the PRINCIPAL INVESTIGATOR becomes
                                            debarred;



 


		(ii)	receipt
                                            of safety information that makes it prudent to do so; or



 


		(iii)	receipt
                                            of data suggesting lack of sufficient efficacy; or



 


		(iv)	noncompliance
                                            with applicable laws and regulations; or



 


		(v)	PRINCIPAL
                                            INVESTIGATOR becomes unaffiliated with INSTITUTION prior to the completion of the Study.



 


Notwithstanding
the above, COMPANY may immediately terminate this Agreement and require that the Study be stopped if within its sole judgment, such immediate
termination is necessary based upon considerations of Subject safety. This Agreement shall also automatically terminate if the authorization
and approval to conduct the Study is rejected or withdrawn by the competent EC or regulatory authority. Upon receipt of notice of Study
termination, INSTITUTION and PRINCIPAL INVESTIGATOR agree to promptly meet and confer to determine an appropriate phase-out for subjects
participating in the Study, and INSTITUTION and PRINCIPAL INVESTIGATOR shall promptly terminate conduct of the Study to the extent medically
permissible for any Subject. In the event of termination hereunder, other than as a result of a material breach by INSTITUTION or PRINCIPAL
INVESTIGATOR, the total sums payable by COMPANY pursuant to this Agreement shall be equitably prorated for actual work advanced to the
date of termination, with any unexpended funds previously paid by COMPANY to INSTITUTION or PRINCIPAL INVESTIGATOR being promptly refunded
to COMPANY. Termination of this Agreement by COMPANY pursuant to this Section 14.2 shall be without penalty or liability therefor on
the part of COMPANY or the payment of any compensation, except as explicitly aforesaid.


 


Termination
of the Study and/or this Agreement for any reason shall not affect any of the rights and obligations of the Parties which shall have
accrued prior to the effective date of the termination. Without derogating from the generality of the above, the provisions of Sections
7.1, 8.2, 9.1, 9.2, 10, 13, this 14.2, 17, 19 and 23 shall survive termination or expiration of this Agreement.


 


In
case the Agreement or Study is terminated by the INSTITUTION or PRINCIPAL INVESTIGATOR, INSTITUTION or PRINCIPAL INVESTIGATOR agree to
inform the COMPANY in writing, outlying the reasons for such earlier termination.


 




    	14



    	 



    

 





	15.	Independent
    Parties


 


INSTITUTION
and PRINCIPAL INVESTIGATOR are acting in the capacity of independent parties hereunder and not as employees or agents of COMPANY.


 


	16.	Conflict
    of Interest


 


INSTITUTION
and PRINCIPAL INVESTIGATOR confirm that there is no conflict of interest between the parties, or with any co- or sub-investigator, that
would inhibit or affect their respective performance under this Agreement and confirm that such performance under this Agreement does
not violate any other agreement with third parties. INSTITUTION and PRINCIPAL INVESTIGATOR will, and will cause all co- and sub-investigators
to, promptly inform COMPANY if any conflict of interest arises during the performance of this Agreement. Not otherwise limiting the foregoing,
as required by law, regulation, or COMPANY policy, PRINCIPAL INVESTIGATOR and each co- and sub-investigator shall provide financial disclosures
of conflicts of interest to COMPANY as COMPANY may request, on forms approved by COMPANY. At the commencement of the Study and during
the time the Study is being conducted and for one (1) year thereafter, the PRINCIPAL INVESTIGATOR and each co- and sub-investigator shall
update such forms promptly and provide the same to COMPANY as may be requested or whenever any material change occurs in the information
disclosed in the previous form.


 


If
INSTITUTION, PRINCIPAL INVESTIGATOR, or any co- or sub-investigator is a member of a committee for any entity that sets formularies or
develops clinical guidelines, then, during the term of the Study and for a period of two (2) years thereafter, INSTITUTION shall, and
INSTITUTION shall require PRINCIPAL INVESTIGATOR and all co- and sub-investigators to: (a) disclose their involvement with the Study
to such committee; and (b) comply with any procedures set forth by such committee with respect thereto.


 


	17.	Publicity
    - Use of Name


 


None
of the parties shall use the name, trademark, service mark, or logo of any other party for any purposes, nor shall any party disclose
the existence or substance of this Agreement except as required by law without prior written consent of the party whose name is proposed
to be used. Notwithstanding the foregoing, COMPANY shall be entitled to disclose the existence and the substance of this Agreement as
part of a due diligence inquiry or similar procedure or as part of representations under agreements to which the COMPANY is a party,
subject to reasonable confidentiality undertakings.


 


	18.	Exhibits


 


In
the event the standards, requirements, or obligations set forth on an Exhibit to this Agreement conflict with the Protocol and/or the
terms herein, the terms of the Protocol, and then the terms of this Agreement, respectively, shall control.


 




    	15



    	 



    

 


	19.	Notice


 


Any
notices given hereunder shall be sent by: (a) mail, return receipt requested; (b) overnight courier service; or (C) personally delivered
as follows:


 


FROM
INSTITUTION/PRINCIPAL INVESTIGATOR TO COMPANY:


 


To


 


Biosight
Ltd.


 


3
Ha’yarden St.,


 


Airport
City, Israel


 


FROM
COMPANY TO INSTITUTION:


To


GFM


Pr.
Pierre FENAUX


Service
d’hématologie séniors


Hôpital
St Louis / Université Paris 7


1
avenue Claude Vellefaux


75010
PARIS, France


 


	20.	Assignment


 


Neither
INSTITUTION nor PRINCIPAL INVESTIGATOR shall assign their rights or duties under this Agreement to another without prior written consent
of the other parties. COMPANY may assign and/or transfer this Agreement and any of its rights, privileges or obligations hereunder, at
its discretion, to an affiliate and/or a successor in interest. Subject to the foregoing, this Agreement shall bind and inure to the
benefit of the respective parties and their successors and assigns.


 


	21.	Agreement
    Modifications


 


This
Agreement, including the Exhibits, may not be altered, amended or modified except by written document signed by all parties.


 


	22.	Counterparts


 


This
Agreement may be executed in two or more counterparts, and signatures may be delivered by facsimile and via email in .PDF, each of which
shall be deemed to be an original and all of which shall be deemed to constitute the same Agreement.


 


	23.	Governing
    Law and Jurisdiction


 


This
Agreement shall be governed by and construed in accordance with the laws of England and Wales without regard to the application of principles
of conflicts of law. Any dispute controversy or claim arising out of, or relating to this Agreement, its interpretation or performance
hereunder shall be settled in the competent courts of London, England.


 


[Remainder
of Page Intentionally Blank]


 


[Signature
Page Follows]


 




    	16



    	 



    

 


IN
WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed by their duly authorized representatives as of the
date first above written.


 


	Biosight Ltd.	 
	 	 	 
	By:	/s/
Dr. Ruth Ben Yakar	 
	Name:	Dr.
Ruth Ben Yakar	 
	Title:
    	CEO	 
	Date:
    	July
    15, 2020	 
	 	 	 
	INSTITUTION	 
	 	 	 
	By:
    	GFM	 
	Name:	Prof.
Pierre FENAUX	 
	Title:
    	President
    of GFM	 
	Date:	July
17, 2020	 
	 	 	 
	ACKNOWLEDGED
    AND AGREED TO:	 
	 	 	 
	By:
    	/s/
    Prof. Pierre FENAUX	 
	Name:	Prof.
Pierre FENAUX	 
	Title:
    	Principal
    Investigator	 
	Date:
    	July
    17, 2020	 


 


	Include
    Exhibits:	A.
    Protocol
	 	B.
Adverse Event Reporting
	 	C.
Budget
	 	D.
Investigator Monitoring Oversight Plan


 



    	17