Document:

Exhibit 4.31

  

CONFIDENTIAL

 

CERTAIN IDENTIFIED INFORMATION HAS BEEN
EXCLUDED FROM THE EXHIBIT BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY
DISCLOSED.

[*****] indicates the redacted confidential
portions of this exhibit.

 

 

 

 

 

 

 

clinical
study supply agreement 

 

 

 

 

 

 

 

between

 

Kamada
LTD.

 

and

 

pari
pharma GMBH 

 

 

 

 

 

 

 

 

 

 

 

    	Clinical Study Supply Agreement Kamada-PARI
 Effective Date: May 8th, 2019, Version: 1.0
	 1/35

     

    

 

Clinical
Study supply agreement

 

This Clinical Study
Supply Agreement (the “CSSA”) is made effective as of May 8th, 2019 (the “CSSA Effective Date”)
by and between KAMADA Ltd., an Israeli company, with a principal place of business at 2 Holzman St., Science Park, P.O. Box 4081,
Rehovot, 7670402, Israel (“KAMADA”) and PARI Pharma GmbH, with its registered office at Moosstrasse 3, 82319 Starnberg,
Germany (“PARI”). In this CSSA, either PARI or KAMADA is referred to as a “Party,” and collectively as the
“Parties.”

 

Recitals

 

WHEREAS, PARI and
KAMADA are parties to a certain License Agreement dated November 16, 2006 (the “License Agreement”).

 

WHEREAS, PARI has
developed and produced an eFlow Technology controller incorporating certain technologies to track, transfer, display and store
information about patients adherence to inhaled medication by using data from their eFlow Technology Nebulizer Systems made available
to the patients and the clinical development team for storing and transmitting nebulizer adherence data (the “eTrack Controller
Kit” as defined in more detail in Schedule 1, Position No. 1) and the PARItrack Web Portal (as further described in Section
2.5 below) to track, display, store and report patients’ adherence to inhaled medication by using the transferred nebulization
data from the eTrack Controller, which together allow access to and evaluation of the nebulization data (which is available only
to KAMADA and the clinical research and development team, but not provided to the patient, subject to personal data protection
law as described in more detail in Schedule 2) (the eTrack Controller Kits and the PARItrack Web Portal are collectively referred
to as “eTrack”); and

 

WHEREAS, KAMADA
desires to use the eTrack under the License Agreement for the purpose of conducting its human factor studies and Phase III clinical
trial relating to its Drug Product, in accordance with the License Agreement (the “Evaluation Studies”), as set forth
under Article 6 “The Device and its Supply” thereof; and

 

WHERAS, PARI, being
the owner of the entire right (including intellectual property rights), title and interest in eTrack, is willing to provide KAMADA
with the eTrack Controller Kits (comprising certain accessories as described in Schedule 1 hereto) and Nebulizer Handsets and
to provide access to the PARItrack Web Portal for the sole purpose of conducting the clinical Evaluation Studies in accordance
with the provisions of the License Agreement; and

 

    	Clinical Study Supply Agreement Kamada-PARI
 Effective Date: May 8th, 2019, Version: 1.0
	 2/35

     

    

 

WHEREAS, the Parties
wish to incorporate and supplement the supply and use of the eTrack and Nebulizer Handsets thereunder into the License Agreement
for the purpose of the performance of the Evaluation Studies; and

 

WHEREAS, terms not
defined in this CSSA shall have the meaning as set forth in the License Agreement.

 

NOW, THEREFORE,
in consideration of the mutual covenants, terms and conditions hereinafter set forth, and intending to be legally bound hereby,
the Parties agree as follows:

 

		1.	Supply and use of material

 

		1.1	Provision of Material

 

PARI will provide eTrack Controller
Kits with monitoring and data transmission functionality used to operate and control Nebulizer Handsets as part of the Device
and as specified in Schedule 1 of this CSSA to KAMADA to conduct the clinical Evaluation Studies under Section 6 of the License
Agreement. Prices and service fees of eTrack are set forth in Schedule 1 of this CSSA. Following completion of the clinical Evaluation
Studies, KAMADA shall ensure that the eTrack Controller Kits are fully returned to PARI and shall retrieve the eTrack Controller
Kits at KAMADA’s expense and the eTrack Controller Kits will be stored by KAMADA or a third party on behalf of KAMADA until
fully returned to PARI.

 

		1.2	Restriction of Use

 

The Parties agree for the
purpose of this CSSA that the term “Device” as used in Section 1.8 of the License Agreement shall include the eTrack
Controller Kit and to the extent applicable the PARItrack Web Portal. In addition to the provisions set forth in the License Agreement,
KAMADA agrees to be bound by the following restrictions of use.

 

Use of eTrack Controller Kits.
KAMADA agrees to comply with all Applicable Laws and Standards applicable to the clinical Evaluation Studies and eTrack. As used
herein, “Applicable Laws and Standards” means (a) all laws, ordinances, rules, directives and regulations applicable
to eTrack, the clinical Evaluation Studies or this CSSA, including without limitation applicable local laws and regulations in
each relevant country in which the clinical trials are conducted or personal data of study participants is processed, (b) applicable
regulations and guidelines of the U.S. Food and Drug Administration (“FDA”) and other regulatory authorities and applicable
guidelines of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for
Human Use (“ICH”); (c) as applicable to the particular activities performed under this CSSA, Good Manufacturing Practices,
Good Laboratory Practices and Good Clinical Practices promulgated by the FDA and other regulatory authorities or the ICH; (d)
any applicable data protection laws and regulations applicable to the clinical Evaluation Studies and the processing of personal
data, including without limitation HIPAA; and (e) all applicable industry and trade standards.

 

    	Clinical Study Supply Agreement Kamada-PARI
 Effective Date: May 8th, 2019, Version: 1.0
	 3/35

     

    

 

Use of the Documentation: Subject
to the terms under the Applicable Laws and Standards, PARI shall provide KAMADA with an appropriate description of eTrack for
use in specific regulatory filings or other documentation (e.g. Patient Information and Consent Form (as defined below), etc.)
required by regulatory authorities for clinical trial applications related to the clinical Evaluation Studies. KAMADA shall not
use any description of eTrack or language on eTrack (e.g., the labelling, including the name) other than that provided by PARI
in any such regulatory documentation without first obtaining PARI’s written approval of the changes to that description.
Any section in a regulatory filing mentioning eTrack must be approved by PARI in writing prior to any submission to such regulatory
authority.

 

Restricted Access to the eTrack
Controller Kits. KAMADA shall only distribute or release the eTrack Controller Kits to any patients taking part in the clinical
Evaluation Studies who have signed the Patient Information and Consent Form (as defined below) (the “Probands”).

 

KAMADA, its Affiliates and
Permitted Sublicensees shall retain control of the Device and shall not distribute or release the Device to any person or entity
other than KAMADA’s, its Affiliates’ and Permitted Sublicensees’ or the clinical trial site’s employees,
consultants or contractors (“KAMADA Representatives”) and individuals who will be participating in the clinical trials
who have a need to access the Device in connection with use of the Device for the clinical trials and who have been advised of
KAMADA’s obligations with respect to such Device. KAMADA shall not allow its Affiliates, its Sublicensees or KAMADA Representatives
to keep or disburse the Device to any other person or other location, unless KAMADA first obtains PARI’s written permission,
such permission shall not unreasonably withheld or delayed. KAMADA shall be liable for the use of the Device by its Affiliates,
its Permitted Sublicensees or KAMADA Representatives in violation of this Section 1.2(d).

 

    	Clinical Study Supply Agreement Kamada-PARI
 Effective Date: May 8th, 2019, Version: 1.0
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The Device is to be used in
accordance with the terms and conditions of this Agreement only by KAMADA, its Affiliates, its Permitted Sublicensees or KAMADA
Representatives or patients participating in the clinical trials under KAMADA’s control, at the clinical trial sites listed
in the applicable purchase order for such Devices accepted by PARI.

 

KAMADA, its Affiliates and
Sublicensees shall conduct the clinical trials pursuant to a written protocol (the “Study Protocol”). KAMADA shall provide
a synopsis of the Study Protocol to PARI prior to the commencement of the applicable clinical trials. Following the completion
of the clinical Evaluation Studies, KAMADA shall use commercially reasonable efforts to ensure that the Material (as described
in Schedule 1, but excluding Pos. 2 of Schedule 1) is fully returned to PARI and shall retrieve the Material at KAMADA’s
expense and the Material shall be stored by KAMADA or a third party on behalf of KAMADA until fully returned to PARI.

 

KAMADA shall not, and shall
cause its Affiliates and Sublicensees not to, subject to analysis or have subjected to analysis the Devices or components constituting
Devices received from PARI for the purpose of reverse engineering or in a manner that would reveal material composition or internal
design or operation of such sample or component or its method of manufacture. KAMADA shall be responsible for any breaches of
this Section 1.2 by any of its Affiliates or Sublicensees.

 

		1.3	Patient Information
                                         and consent Form

 

In addition to any other information
material or declarations of consent that may be required to conduct the clinical Evaluation Studies, KAMADA shall not include
any patients into the clinical Evaluation Studies who will use eTrack who did not validly and unequivocally sign a Patient Information
and Consent Form approved by the applicable Ethics Committees (the “Patient Information and Consent Form”) containing
substantially all of the content of Schedule 2 of this CSSA. The content of Schedule 2 may be modified if required by the regulatory
authority of the country in which the clinical Evaluation Studies will be conducted and KAMADA shall be entitled to add provisions
and third party entities as processors to Schedule 2, provided that any change in Section 1 of Schedule 2 requires PARI’s prior
written approval before implementation.

 

    	Clinical Study Supply Agreement Kamada-PARI
 Effective Date: May 8th, 2019, Version: 1.0
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		2.	Data collection and transmission

 

		2.1	Any data captured by the investigational
                                         eTrack Controller Kit is transmitted encrypted (in a format determined by PARI but at
                                         all times in compliance with Applicable Laws and Standards) via telecommunication services
                                         to be provided by a third party (the “Telecommunication Services”) to a computer
                                         server hosted by or on behalf of PARI (the “PARI Server”). The Parties agree
                                         that, except as provided otherwise under Schedule 3 to this CSSA, as between the Parties,
                                         KAMADA shall act as the data controller and therefore is responsible for compliance with
                                         all data controller’s obligations under the Applicable Laws and Standards. PARI operates
                                         the PARItrack Web Portal on the PARI Server, shall use commercially reasonable efforts
                                         to ensure the correctness of the data displayed in the PARItrack Web Portal and shall
                                         act as KAMADA’s contract data processor (and therefore, if applicable, as a business
                                         associate under HIPAA) and, subject to any applicable law, shall have no responsibility
                                         towards Probands or other third parties other than KAMADA. KAMADA confirms to PARI that,
                                         as between the Parties, only KAMADA and no third party will have ownership of the Probands’
                                         personal data collected during the clinical Evaluation Studies. In case of access to
                                         such personal data by third parties, KAMADA will implement the legally required contractual
                                         provisions with such third parties and, if necessary, with the Probands, and PARI shall
                                         implement the legally required contractual provisions with any third party acting as
                                         PARI’s data processor, including a data processing agreement as required in Schedule
                                         3. To comply with applicable data protection laws, if applicable, the Parties will enter
                                         into the data processing agreement attached to this CSSA as Schedule 3 or any other written
                                         instrument containing all of the content of Schedule 3 (the “Data Processing Agreement”).
                                         In the event that applicable data protection laws require a change to the data protection
                                         provisions of this CSSA (including Schedule 3), the Parties shall amend the Data Processing
                                         Agreement accordingly.

 

		2.2	PARI makes no representation regarding
                                         availability, timeline or functionality of the Telecommunication Services, but shall
                                         be responsible for the collection of the data by the eTrack Controller Kits and its processing
                                         on the PARI Central Servers in accordance with all Applicable Laws, Standards and the
                                         Data Processing Agreement. The Parties acknowledge that a delay or cancelation of the
                                         third party Telecommunication Services or their implementation with eTrack may lead to
                                         potentially severe restriction of the functionalities of eTrack.

 

    	Clinical Study Supply Agreement Kamada-PARI
 Effective Date: May 8th, 2019, Version: 1.0
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		2.3	KAMADA ACKNOWLEDGES THAT THE TELECOMMUNICATION
                                         SERVICES ARE MADE AVAILABLE ONLY WITHIN THE OPERATING RANGE OF THE NETWORK. SERVICE MAY
                                         BE TEMPORARILY REFUSED, INTERRUPTED, OR LIMITED BECAUSE OF AMONG OTHER THINGS: (i) FACILITIES
                                         LIMITATIONS; (ii) TRANSMISSION LIMITATIONS CAUSED BY ATMOSPHERIC, TERRAIN, OTHER NATURAL
                                         OR ARTIFICIAL CONDITIONS ADVERSELY AFFECTING TRANSMISSION, AND OTHER CAUSES REASONABLY
                                         OUTSIDE OF PARI’S OR ITS SUBCONTRACTORS’ CONTROL; OR (iii) EQUIPMENT MODIFICATIONS,
                                         UPGRADES, RELOCATIONS, REPAIRS, AND OTHER SIMILAR ACTIVITIES NECESSARY FOR THE PROPER
                                         OR IMPROVED OPERATION OF THE TELECOMMUNICATION SERVICES. CONNECTIONS MAY BE “DROPPED”
                                         (I.E., INVOLUNTARILY DISCONNECTED) FOR A VARIETY OF REASONS, INCLUDING, WITHOUT LIMITATION,
                                         ATMOSPHERIC CONDITIONS, TOPOGRAPHY, WEAK BATTERIES, SYSTEM OVERCAPACITY, MOVEMENT OUTSIDE
                                         A SERVICE AREA OR GAPS IN COVERAGE WITHIN A SERVICE AREA.

 

		2.4	Without derogating from the foregoing,
                                         PARI undertakes, for no consideration, to make commercially reasonable efforts to fix,
                                         within reasonable time and in compliance with the Data Processing Agreement, any defect
                                         or bug discovered in the data transmission, or its implementation with eTrack which is
                                         reported by KAMADA to PARI, as follows: PARI will (i) identify the source of the bug
                                         or defects as stated above, (ii) determine appropriate Solutions to repair such bug or
                                         defects, and (iii) initiate without undue delay repairs, including, if commercially reasonable,
                                         by giving patches or other temporary repairs of the services to allow for continuous
                                         use thereof.

 

		2.5	EXCLUDING CASES OF PARI’S GROSS NEGLIGENCE,
                                         WILFUL MISCONDUCT, NEITHER PARI NOR PARI’S SUBCONTRACTORS NOR THE UNDERLYING CARRIER
                                         SHALL INCUR ANY LIABILITY FOR ITS INABILITY TO PROVIDE ADEQUATE SERVICES HEREUNDER IF
                                         SUCH INABILITY IS DUE TO THE LIMITATIONS SET FORTH IN SECTION 2.3 ABOVE OR TO CAUSES
                                         BEYOND THE REASONABLE CONTROL OF PARI, ITS SUBCONTRACTORS OR THE UNDERLYING CARRIER.
                                         EXCLUDING CASES OF BREACH OF THE DATA PROCESSING AGREEMENT, PARI SHALL NOT BE RESPONSIBLE
                                         FOR ANY ACT OR OMISSION RELATED TO EQUIPMENT OR SYSTEMS USED IN CONNECTION WITH THE TELECOMMUNICATION
                                         SERVICES OR OTHER DATA PROCESSING ACTIVITIES OTHER THAN eTrack.

 

    	Clinical Study Supply Agreement Kamada-PARI
 Effective Date: May 8th, 2019, Version: 1.0
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		2.6	Privacy:
                                         THE NETWORK USED TO PROVIDE THE TELE-COMMUNICATION SERVICES HAS MANY COMPLEX ELEMENTS
                                         AND IS NOT GUARANTEED AGAINST EAVESDROPPERS OR INTERCEPTORS. EXCLUDING CASES OF PARI’S
                                         GROSS NEGLIGENCE, WILFUL MISCONDUCT OR BREACH OF THE DATA PROCESSING AGREEMENT, AND EXCEPT
                                         AS OTHERWISE PROVIDED BY THE DATA PROCESSING AGREEMENT, KAMADA AGREES THAT NEITHER PARI
                                         NOR ITS SUBCONTRACTORS NOR AN UNDERLYING CARRIER SHALL BE LIABLE TO KAMADA FOR ANY LACK
                                         OF PRIVACY OR SECURITY.

 

		2.7	The Parties agree that any rights
                                         in and to the software backend solution for managing the functionality of data transfer
                                         from eTrack, processing and accessing the collected data and any related features (collectively
                                         the “PARItrack Web Portal”) and eTrack Controller Kit, including without limitation
                                         copyrights, know-how and other intellectual property rights, shall at all times remain
                                         the sole and exclusive property of PARI. Any inventions, improvements or discoveries
                                         that are based upon, or derived from the eTrack, but not from any data collected using
                                         the Probands, shall be promptly disclosed to and are and shall be the sole and absolute
                                         property of PARI. PARI declares and covenants that it retains all right, title to and
                                         interest to the PARItrack Web Portal and eTrack Controller Kit, including all intellectual
                                         property ownership rights related thereto, or that it is an authorized licensee of the
                                         PARItrack Web Portal and eTrack Controller Kit for the duration of this CSSA. KAMADA
                                         shall be granted a license to use PARI’s eTrack Controller Kit for the sole purpose of
                                         conducting the clinical Evaluation Studies in accordance with the provisions of the License
                                         Agreement. The eTrack Controller Kit shall be considered part of the Device as defined
                                         in Section 1.8 of the License Agreement.

 

		2.8	In accordance with Section 15.3 of
                                         the License Agreement, Kamada shall solely own the data collected and captured by PARI’s
                                         eTrack during the Evaluation Studies, including without limitation any know-how and intellectual
                                         property rights conceived in the course of such Evaluation Studies relating to the Drug
                                         Product, and shall be exclusively entitled to incorporate such data and results in its
                                         drug master file and to disclose them to any regulatory authority, worldwide, without
                                         paying any additional consideration to PARI. In addition, Kamada shall be solely entitled
                                         to make any commercial use in such data, subject to the terms under the Applicable Laws
                                         and the Data Processing Agreement.

 

    	Clinical Study Supply Agreement Kamada-PARI
 Effective Date: May 8th, 2019, Version: 1.0
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		2.9	Subject to the terms under the Applicable
                                         Laws and the Data Processing Agreement, PARI may use the data captured by the investigational
                                         eTrack Controller Kit together with other technical data (including the serial numbers
                                         of the aerosol heads used with such investigational eTrack Controller Kit) solely for
                                         PARI’s internal business purposes to monitor and analyze the Device performance.

 

		3.	miscellaneous

 

		3.1	Term and Termination

 

This CSSA shall commence as
of the CSSA Effective Date and expire concurrently with the expiration or termination of the License Agreement unless otherwise
agreed to in writing by the Parties. Either Party may terminate this CSSA (i) upon ninety (90) days’ written notice, or
(ii) upon written notice to the other Party in the event a material breach of this CSSA by such other Party (including an infringement
of third party’s IP rights by PARI’s PARItrack Web Portal or eTrack Controller Kit) is incurable or remains uncured sixty
(60) days after notice of such breach was received by such other Party. Notwithstanding the termination of this CSSA, the provisions
of Sections 2.3, 2.4, 2.8, 2.9, 3.1, and 3.2 shall survive the termination of this CSSA.

 

		3.2	Disclaimer of Warranties and Limitation
                                         of Liability; Indemnification

 

EXCLUDING CASES OF FRAUD AND
INTENTIONAL MISLEADING, eTrack AND CONFIDENTIAL INFORMATION IS PROVIDED “AS IS” AND PARI MAKES NO REPRESENTATION OR
WARRANTY, EITHER EXPRESSED OR IMPLIED, CONCERNING eTrack OR THE CONFIDENTIAL INFORMATION CONTAINED THEREIN OR ANY TELECOMMUNICATION
SERVICES. PARI DISCLAIMS ALL EXPRESS AND IMPLIED WARRANTIES RELATED TO eTrack INCLUDING WITHOUT LIMITATION FOR MERCHANTABILITY
OR FITNESS FOR A PARTICULAR PURPOSE; CONFIDENTIAL INFORMATION AND THE TELECOMMUNICATION SERVICES, INCLUDING BUT NOT LIMITED TO
THE IMPLIED WARRANTY OF MERCHANTABILITY AND THE IMPLIED WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE.

 

    	Clinical Study Supply Agreement Kamada-PARI
 Effective Date: May 8th, 2019, Version: 1.0
	 9/35

     

    

 

Notwithstanding the generality
of the foregoing paragraph, if eTrack Controller Kits or Nebulizer Handsets or Hubs supplied by PARI to KAMADA
hereunder should not correspond with the Device Specifications (as defined in the License Agreement or amended in accordance
with Appendix D of the License Agreement) or KAMADA becomes aware of defective Devices at the time of delivery, PARI shall
at its own discretion rectify that defect, provide a replacement product, or provide a credit note to offset any future payment
or, in case no later payment is due, repay the purchase price for the affected product. KAMADA’s claims for defects of the Device
are subject to notification of PARI of any visibly detectable defects and quantity variances within sixty (60) days after receipt
of the relevant delivery. In case of defects of the Device, which were not visibly detectable at receipt by customary inspection
of such Device made in due care by a suitable qualified person, PARI shall be notified by KAMADA immediately, but not later than
ten (10) Business Days from such recognition of the defect. KAMADA’s claims for defects shall expire in any case eighteen (18)
months after delivery of an eTrack Controller Kit to KAMADA. KAMADA shall provide defect Devices to PARI for PARI’s inspection
and evaluation of the claimed defect. In the event eTrack data collection, transmission and processing services described or amended
in the License Agreement do not comply with this CSSA or the Applicable Laws and Standards, PARI shall use commercially reasonable
efforts to amend its services and to repeat such services in compliance with this CSSA.

 

IN NO EVENT SHALL PARI BE LIABLE TO KAMADA
FOR ANY SPECIAL, INDIRECT, INCIDENTAL, CONSEQUENTIAL DAMAGES OR DAMAGES FOR LOST PROFITS ARISING FROM THE USE OF eTrack OR CONFIDENTIAL
INFORMATION, HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY. This shall not apply either insofar as liability is mandatory, e.g.
under the German Product Liability Act, in cases of intent or gross negligence or of injury of life, limb or health, as well as
of breach of essential contractual obligations. However, claims for damages in case of breach of essential contractual obligations
shall be limited to foreseeable damage typical for the contract insofar as there is no gross negligence and no liability for injury
of life, limb or health.

 

Section 18 (Indemnification)
of the License Agreement shall apply to this CSSA mutatis mutandis.

 

		3.3	Counterparts

 

This CSSA may be executed
in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the
same instrument.

 

    	Clinical Study Supply Agreement Kamada-PARI
 Effective Date: May 8th, 2019, Version: 1.0
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		3.4	Severability

 

If any portion of this CSSA
is determined invalid by any court, the rest shall remain in force and shall be construed as if not containing the invalid provision.
The Parties undertake to replace the invalid provision or parts thereof by a new provision which will approximate as closely as
possible the economic result intended by the Parties.

 

		3.5	Applicable Provisions

 

This CSSA shall supplement
the License Agreement. The Parties agree that the applicable provisions of the License Agreement shall apply to this CSSA mutatis
mutandis, including without limitation Article 25. “Governing Law; Arbitration”, Article 20. “Relationship between
the Parties”, Article 22. “Force Majeure”, Article 23. “Confidentiality” and Article 26. “Notices”.

 

[Signature Page
follows]

 

    	Clinical Study Supply Agreement Kamada-PARI
 Effective Date: May 8th, 2019, Version: 1.0
	 11/35

     

    

 

IN WITNESS WHEREOF,
the Parties have entered into the CSSA Agreement as of the CSSA Effective Date:

 

SIGNATURES

 

	SIGNED for and on behalf of	 	 	 	SIGNED for and on behalf of	 	 
	KAMADA Ltd.	 	 	 	PARI Pharma GmbH	 	 
	 	 	 	 	 	 	 
	/s/ Amir London	 	 	 	 	 	 
	Amir London	 	Date	 	*****	 	Date
	CEO	 	 	 	 	 	 
	 	 	 	 	 	 	 
	/s/ Chaime Orlev	 	 	 	 	 	 
	Chaime Orlev	 	Date	 	 	 	 
	CFO	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 

 

    	Clinical Study Supply Agreement Kamada-PARI
 Effective Date: May 8th, 2019, Version: 1.0
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Schedule 1

Prices and Service Fees

 

Following table contains prices and service
fees for eTrack.

 

	Pos	Description	Price
	1	eTrack Controller Kit

        (comprising of the following components):

        ·      One
        (1) eTrack Controller

        ·      One
        (1) carrying bag

        ·      One
        (1) Nebulizer Handset connection cord 

        ·      One
        (1) AC power supply 

        ·      All
        outer packaging 

        ·      Instructions
        for Use 

        ·      Batteries

        ·      One
        (1) easycare cleaning aid (the “Easycare”), if required
	[*****]
	2	One
    (1) hub for access to  Telecommunication Services (the “Hub”)	[*****]
	3	Nebulizer
    Handset (including required aerosol heads)	To
    be determined

 

[Table continues
on following page]

 

    	Clinical Study Supply Agreement Kamada-PARI
 Effective Date: May 8th, 2019, Version: 1.0
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[Continuing table
from preceding page - Schedule 1]

 

	Pos	Description	Price
	4	One
    time set-up fee per trial (including the first training of study personnel)	[*****]
	5	Monthly
    fee for the PARItrack Web Portal	Up
    to [*****] patients per
    trial	[*****]
	Between
    [*****] and [*****]
    patients per trial	[*****]
	[*****]
    patients and more per trial	[*****]
	6	Data
    transmission fee per month and active Hub	[*****]
	7	1st
    level support / training (excluding the first training of study personnel)	[*****]
	8	Travel
    expenses	[*****]

 

    	Clinical Study Supply Agreement Kamada-PARI
 Effective Date: May 8th, 2019, Version: 1.0
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Schedule 2

 

PATIENT INFORMATION AND CONSENT FORM

 

We hereby inform you as follows:

 

		1.	INVESTIGATIONAL EFLOW Technology
                                         NEBULIZER SYSTEM WITH ETRACK CONTROLLER

 

		(a)	Ownership

 

The investigational eFlow
Technology nebulizer system handed out to you is provided only for the purpose to conduct the [Partner_Study_Title_No] and as
long such Study is conducted. Ownership to such nebulizer system will not be transferred to you and you are obligated to return
the nebulizer system after the conclusion of the Study or anytime upon request.

 

		(b)	Use of the investigational
                                         eFlow Technology nebulizer system

 

The nebulizer system is intended
to be used by you exclusively for the purpose to conduct the Study.

 

You are not allowed to:

 

		·	use
                                         the nebulizer system or any component thereof (including the hub) for any purpose other
                                         than the inhalation therapy within the Study as advised by the investigator;

 

		·	give
                                         the nebulizer system to any other person or entity (other than persons helping you with
                                         your inhalation therapy);

 

		·	destroy,
                                         modify, analyze, reverse engineer, the nebulizer system or any components thereof, including
                                         any accessories and the hub, or modify, analyze, reverse compile or translate any software
                                         contained therein;

 

		2.	INFORMATION AND CONSENT TO THE PROCESSING
                                         OF PERSONAL DATA WITH ETRACK

 

You are thinking of taking part in the
clinical study [Partner_Study_Title_No]. This study will be conducted by using an eTrack Controller which will collect and transfer
certain data about your use of the device. We hereby inform you as follows with respect to the processing of your personal data:

 

		(a)	What data will
                                         be processed and what is the purpose of the processing?

 

The eTrack Controller, once
connected to the internet via the wireless hub, will collect and transfer the serial number of the inhalation device and certain
data about the use of the device such as the time of starting the nebulization and the time nebulization ends. Additional technical
data of your inhalation device may be processed as well. Other data like your name, address, birthdate, etc. will not be transmitted
but an allocation of the processed data to your person will take place at the receiving study centers via the serial number of
your eTrack Controller. This is why we consider the pseudonymized data processed as your personal data.

 

    	Clinical Study Supply Agreement Kamada-PARI
 Effective Date: May 8th, 2019, Version: 1.0
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Your personal and sensitive
data will be collected and processed for the following purposes:

 

Provision of telemedicine
services, in particular delivery of data showing the adherence to inhaled medication in the course of the clinical study [Partner_Study_Title_No].

 

		(b)	Modalities of processing

 

Your data will be processed
by means of electronic devices and will be transmitted through IT networks with a high level of security. In particular, all preventative
measures set forth in data protection legislation, including measures for segregation and encryption of data, will be adopted.
Your data will be encrypted directly after creation within the eTrack Controller and transmitted only in encrypted form and without
connection to your name (i.e. pseudonymous). Third parties involved in data transmission, other than the receiving healthcare
professionals at the study centers as well as the principal investigator of the study, will not have the means to de-pseudonym
your data.

 

		(c)	Scope of communication
                                         of data

 

Your data will be processed
through IT instruments that will allow health operators to access patients’ information and monitor their treatment. Access
to your health data may only occur through the points of access authorized to access such data by authorized health operators.

 

Your data will be transmitted,
by means of an IT network, to a central collection system. In order to make your data accessible to authorized health operators,
your data may be processed by third parties entrusted with technical, logistic, IT, storage and transmission services. If collected
within the European Union, your data will not be transferred outside the European Union. However, your data may be accessible
in pseudonymized and encrypted form only for purposes of 24/7 technical support provided by service personnel in other territories
by contractors of the data processor who are bound by confidentiality obligations and EU Commission standard contractual clauses
outside of the European Union, including but not limited to the United States of America, whose legislation may not ensure the
same level of protection of personal data as the one ensured in the European Union.

 

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		(d)	Data controller
                                         and data processor

 

For the purposes of the provision
of telemedicine services, KAMADA Ltd., the sponsor of the [Partner_Study_Title_No] study, shall act as data controller and PARI
Pharma GmbH, Moosstrasse 3, 82319 Starnberg, Germany, shall act as data processor. PARI may internally use pseudonymized data
for the sole purpose of monitoring and analyzing the technical performance of your nebulizer system.

 

		(e)	Categories of persons
                                         in charge of the processing

 

Healthcare operators and administrative
personnel subject to professional secrecy obligations may process the data, each within their respective competences. The data
controller and the data processor indicated in this information document may also entrust their respective personnel, collaborators,
contractors and other third parties that may perform on their behalf and under their supervision supporting services for the processing
of the data. Recipient of your personal data are the healthcare professionals conducting the [Partner_Study_Title_No] study at
the [Partner_Study_Center].

 

		(f)	Sub-processor

 

Your data will be also processed
by sub-processors engaged by PARI. KAMADA and PARI ensure that any processing of your data by such sub-processors will be subject
to data processing agreements ensuring your rights under applicable data protection laws. Should you wish to obtain more information
on such sub-processors, please contact KAMADA using the contact details below.

 

		(g)	Duration of processing

 

Your data will be processed
for as long as your handheld nebulizer device is connected to the internet via the 2net Hub.

 

		(h)	Exercise of rights

 

You are entitled, inter alia,
to the following rights:

 

Request the following information:
origin of the data; purposes and modalities of processing; logic applied to the processing; identifying information of the data
controller and data processors; persons or categories of persons to whom the data may be communicated or that may access the data
as data processors or persons in charge of the processing;

 

Request the update, correction
or integration of your data;

 

Request the cancellation,
anonymization or block of your data without prejudice to the obligations to keep the data provided by law.

 

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You may exercise the above
mentioned rights by submitting a request to:

 

KAMADA Ltd.

 

[Partner_Address]

 

[Partner_Phone]

 

[Partner_Email]

 

		(i)	Optional/mandatory
                                         nature of the consent and consequences of denial

 

Your consent is optional.
You are free to refuse your consent or revoke your consent at any time without stating any reason. However, failure to provide
your consent for the purposes of the provision of telemedicine services will prevent the processing of your data for the purposes
of providing such services to you. In this case, your participation in the [Partner_Study_Title_No] study will not be possible.

 

By signing this document you consent to
the processing of your personal data for the purposes and in the way as described above.

 

I hereby confirm that I understand and
agree to the information contained herein above.

 

	Place
    and Date:  	 	 

 

	 	 	 	 
	Full Name
    (block letters)	 	Signature	 

 

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Schedule 3

 

DATA PROCESSING AGREEMENT

 

The Data Processing Agreement set forth
in this Schedule 3 hereby is incorporated into and made part of the CSSA. This Schedule 3 shall apply when KAMADA is acting as
a data controller (particularly in the meaning of Article 4 No.7 of EU Regulation 2016/679) (“Controller”), and PARI
is acting as a data processor for KAMADA (particularly in the meaning of Article 4 No.8 of EU Regulation 2016/679) (“Processor”).

 

		1.	DEFINITIONS

 

		1.1	Unless otherwise specified in this
                                         Schedule 3, all capitalized terms used in this Schedule 3 not otherwise defined in this
                                         Schedule 3 or otherwise in the CSSA have the meanings established for purposes of EU
                                         Regulation 2016/679. Capitalized terms used in this Schedule 3 that are not otherwise
                                         defined in this Schedule 3 and that are defined in the CSSA shall have the respective
                                         meanings assigned to them in the CSSA.

 

		1.2	“GDPR” shall mean EU
                                         Regulation 2016/679 of the European Parliament and of the Council of 27th April 2016
                                         on the protection of natural persons with regard to the processing of personal data and
                                         on the free movement of such data (“General Data Protection Regulation”), as
                                         well as any EU or national statute implementing or replacing it.

 

		1.3	“Applicable Laws” shall
                                         mean (a) European Union or Member State laws with respect to any Controller Personal
                                         Data in respect of which the Controller is subject to EU Data Protection Laws; and (b)
                                         any other applicable law with respect to any Controller Personal Data in respect of which
                                         the Controller is subject to any other Data Protection Laws

 

		1.4	“Data Protection Laws”
                                         shall mean EU Data Protection Laws and, to the extent applicable, the data protection
                                         or privacy laws of any other country;

 

		1.5	“EU Data Protection Laws”
                                         shall mean EU Directive 95/46/EC, as transposed into domestic legislation of each Member
                                         State and as amended, replaced or superseded from time to time, including by the GDPR
                                         and laws implementing or supplementing the GDPR;

 

		1.6	“Breach” shall mean the
                                         acquisition, access, use or disclosure of PD in a manner not permitted by the GDPR or
                                         national data protection laws or this Schedule 3, as well as a ‘personal data breach’
                                         in the meaning of EU Directive 2002/58/EC of the European Parliament and of the Council
                                         of 12 July 2002 concerning the processing of personal data and the protection of privacy
                                         in the electronic communications sector (Directive on privacy and electronic communications).

 

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		1.7	“Compliance Date” shall
                                         mean, in each case, the date by which compliance is required under the referenced provision
                                         of GDPR or its implementing regulations, as applicable; provided that, in any case for
                                         which that date occurs prior to the CSSA Effective Date, the Compliance Date shall mean
                                         that CSSA Effective Date.

 

		1.8	“Data Subject” shall
                                         mean a data subject as defined in Article 4 No.1 of the GDPR.

 

		1.9	“Personal Data” or “PD”
                                         shall have the meaning as provided for in Article 4 No.1 of the GDPR.

 

		1.10	“Electronic Protected Health
                                         Information” (“ePHI”) shall mean PHI as defined in Section 1.11 that
                                         is transmitted or maintained in electronic media.

 

		1.11	“PHI” shall mean Personal
                                         Data concerning health, as defined in Article 4 No.15 of the GDPR, and is limited to
                                         the data concerning health received from, or received or created on behalf of, KAMADA
                                         by PARI pursuant to performance of the Services.

 

		1.12	“Security Rules” shall
                                         mean the EU or national security regulations, whether or not included in the GDPR, with
                                         respect PHI.

 

		1.13	“Services” shall mean,
                                         to the extent and only to the extent they involve the processing of PD, the services
                                         provided by PARI to or on behalf of KAMADA under the CSSA.

 

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		2.	SCOPE, ROLES OF THE PARTIES, OWNERSHIP
                                         OF PD

 

		2.1	This Schedule 3 applies to all PD
                                         that PARI collects, processes and uses in the course of providing the Services under
                                         the CSSA and in accordance with KAMADA’s instructions.

 

	Kind
    of PD concerned:	Serial number of the device;

        Serial number of aerosol heads
        used in the device;

	 	 
	 	Date, time and duration of nebulization
        and easycare backwash with such device;

        patient ID that is collected under
        the PARItrack portal;

        patient’s study start/end;
        and therapy monitoring start/end.

	 	 
	Data Subjects
    concerned:	Probands
    participating in KAMADA’s clinical studies which comply with the Development Agreement.
	 	 
	Purpose of
    collection, processing and use of PD:	Provision
    of telemedicine services, in particular delivery of data showing probands’ adherence to inhaled medication.

 

		2.2	Without prejudice to processing of
                                         PD that is carried out in accordance with this Data Processing Agreement, in the event
                                         that PARI infringes the Applicable Laws and this Data Processing Agreement by processing
                                         the PD for another reason than to provide the Service, the Processor will be regarded
                                         as the controller in respect of that processing. It should be noted that PARI, under
                                         the aforementioned circumstances, will be fully liable as the controller for such processing
                                         under the Applicable Laws including in relation to any sanctions under the said provisions.

 

		3.	RESPONSIBILITIES OF PARI

 

With regard to its collection, processing
and use of data that is PD, PARI agrees to:

 

		3.1	collect, process and use PD only
                                         as necessary to provide the Services, including
                                         monitoring and analysing the performance of the nebulizer systems,
                                         and in accordance with the instructions given by KAMADA in text format or oral
                                         instructions that are then confirmed in text format from time to time, and in compliance
                                         with each applicable requirement of the GDPR or as otherwise required by Applicable Law.
                                         PARI shall immediately inform KAMADA in writing if, in PARI’s opinion, an instruction
                                         infringes Data Protection Laws, and provide an explanation of the reasons for this opinion
                                         in writing. PARI shall pursue appropriate investigations, if PARI doubts the lawfulness
                                         of an instruction.

 

		3.2	inform KAMADA in writing, in case
                                         PARI is required to process PD under mandatory laws, before processing unless that law
                                         prohibits such information on important grounds of public interests, in which case PARI
                                         shall immediately inform KAMADA without undue delay once PARI is permitted to inform
                                         KAMADA.

 

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		3.3	taking into account the nature
                                         of the processing, implement and use appropriate administrative, organizational, physical
                                         and technical safeguards, and at all times as may be required by Applicable Laws, to
                                         (i) prevent use or disclosure of PD other than as permitted or required by this Schedule
                                         3; (ii) appropriately protect the confidentiality, integrity, and availability of the
                                         PD that PARI creates, receives, maintains, or transmits on behalf of KAMADA; (iii) assist
                                         KAMADA when data subjects make use of their rights under Chapter III of the GDPR and
                                         (iv) as of the Compliance Date, comply with the Security Rules which shall ensure a level
                                         of security appropriate to the risk in accordance with GDPR Art. 32. Exhibit 1 to
                                         this Schedule 3 contains a description of safeguards implemented by PARI.

 

		3.4	without unreasonable delay, report
                                         to KAMADA (i) any use or disclosure of PD not provided for by this Schedule 3 of which
                                         it becomes aware; or (ii) any accidental or unlawful destruction or accidental loss,
                                         alteration, unauthorized disclosure or access, and against all other unlawful forms of
                                         processing.

 

		3.5	in the event of a Breach or in
                                         the event PARI has a reason to believe that a Breach occurred , without any delay, and
                                         in any event no later than two (2) working days after discovery, PARI shall provide KAMADA
                                         with written notification that includes a description of the Breach, the relevant data
                                         accessed, disclosed or used pursuant to such Breach, a list of Data Subjects and other
                                         information as required by, and in accordance with, the data breach notification requirements
                                         set forth in the GDPR and EU Directive 2002/58/EC of the European Parliament and of the
                                         Council of 12 July 2002 concerning the processing of personal data and the protection
                                         of privacy in the electronic communications sector (Directive on privacy and electronic
                                         communications). In case not all information is already available after two (2) working
                                         days, PARI shall inform KAMADA of data breach and provide further information without
                                         undue delay once it is reasonably available in order to enable KAMADA to comply with
                                         applicable breach notification requirements under Applicable Laws.

 

		3.6	use its best efforts to immediately
                                         remedy any security incident and Breach that occurred on PARI information systems and
                                         prevent any further consequences at its own expense in accordance with Applicable Laws,
                                         regulations and standards.

 

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		3.7	assist KAMADA by providing necessary
                                         information, insofar as this is possible, for the fulfilment of KAMADA’s obligations
                                         to respond to requests to exercise Data Subject rights under the Data Protection Laws.
                                         PARI shall promptly notify KAMADA if it receives a request from a Data Subject under
                                         any data protection law in respect of Controller Personal Data, and shall document, and
                                         within five (5) working days after receiving a written request from KAMADA, make available
                                         to KAMADA, information necessary for KAMADA to comply with an information request of
                                         Data Subject and upon written notice of KAMADA implement any Data Subject’s request
                                         concerning the correction, deletion or blocking of data, in accordance with GDPR.

 

		3.8	ensure that it does not respond
                                         to any Data Subject’s request, except on the documented instructions of KAMADA or as
                                         required by Applicable Laws to which PARI is subject, in which case PARI shall to the
                                         extent permitted by Applicable Laws inform KAMADA of that legal requirement before PARI
                                         responds to the request.

 

		3.9	notwithstanding Section 3.7, in
                                         the event that PARI in connection with the Services uses or maintains an electronic health
                                         record of PHI of or about a Data Subject, then PARI shall only if and as directed by
                                         KAMADA, make an accounting of disclosures of PHI directly to such Data Subject within
                                         five (5) working days, in accordance with the requirements for accounting for disclosures
                                         made through an electronic health record, as of its Compliance Date.

 

		3.10	provide access, within five (5)
                                         working days after receiving a written request from KAMADA, to PHI in a set of data concerning
                                         health relating to a Data Subject, to KAMADA, sufficient to allow KAMADA to comply with
                                         the requirements of the GDPR.

 

		3.11	notwithstanding Section 3.7, in
                                         the event that PARI in connection with the Services uses or maintains an electronic health
                                         record of PHI of or about a Data Subject, then PARI shall provide an electronic copy
                                         of the PHI within two (2) working days, to KAMADA, sufficient to allow KAMADA to comply
                                         with GDPR requirements as of its Compliance Date, all in accordance with the GDPR as
                                         of its Compliance Date.

 

		3.12	to the extent that the PHI in
                                         PARI’s possession constitutes data concerning health relating to a Data Subject,
                                         PARI shall make available, within five (5) working days after a written request by KAMADA,
                                         PHI for amendment and incorporate any amendments to the PHI as directed by KAMADA, all
                                         in accordance with the GDPR.

 

		3.13	assist KAMADA with respect to,
                                         where applicable, data protection impact assessment in the meaning of Art. 35 and
                                         36 of the GDPR, by providing such information and cooperation as KAMADA may require,
                                         for the purpose of assisting it in carrying out a data protection impact assessment and
                                         periodic reviews to assess if the processing of PD is performed in compliance with the
                                         data protection impact assessment and by assisting KAMADA with prior consultations with
                                         any competent data privacy authorities, and in case of a Breach.

 

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		3.14	not make or cause to be made any
                                         communication about a product or service that is prohibited by the GDPR or applicable
                                         law as of its Compliance Date.

 

		3.15	not make or cause to be made any
                                         written fundraising communication that is prohibited by applicable law as of its Compliance
                                         Date.

 

		3.16	shall appoint a data protection
                                         officer that has sufficient mandate and responsibilities to fulfil his or her tasks set
                                         forth in Art. 38 and 39 GDPR and that monitors compliance of the data processing
                                         for the purpose of this Data Processing Agreement and the GDPR on a permanent and continuous
                                         basis.

 

		4.	RESPONSIBILITIES OF KAMADA

 

In addition to any other obligations set
forth in the CSSA, including in this Schedule 3, KAMADA:

 

		4.1	shall be responsible for using
                                         administrative, physical and technical safeguards at all times to maintain and ensure
                                         the confidentiality, privacy and security of PHI transmitted by KAMADA to PARI pursuant
                                         to the CSSA, including this Schedule 3, in accordance with the standards and requirements
                                         of HIPAA (if applicable) and the GDPR, until such PHI is received by PARI.

 

		4.2	shall ensure that there is a legal
                                         ground for processing the PD covered by this Data Processing Agreement.

 

		4.3	shall be responsible for implementation
                                         of procedures for Data Subjects’ rights to access to personal data concerning health
                                         as required under Article 15 GDPR and shall function as point of contact for Data Subjects
                                         seeking to exercise these rights.

 

		4.4	shall appoint a data protection
                                         officer that has sufficient mandate and responsibilities to fulfil his or her tasks set
                                         forth in Art. 38 and 39 GDPR, to function as single point of contact with regard
                                         to the processing of Personal Data contemplated under this Data Processing Agreement
                                         and that monitors compliance of Processor and Controller for the purpose of this Data
                                         Processing Agreement and the GDPR on a permanent and continuous basis.

 

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		5.	SUB PROCESSING

 

		5.1	PARI shall provide KAMADA with
                                         a full list of sub-processors, including the name and jurisdiction of each sub-processor
                                         and the type of the processing to be undertaken by such sub-processors, before starting
                                         any processing operations concerning PD under the Agreement. PARI shall inform KAMADA
                                         of any intended changes concerning the addition or replacement of any sub-processors
                                         with KAMADA being permitted to object to such a change upon reasonable grounds only,
                                         by sending a notice to PARI, before the PD is made accessible to the sub-processor. If
                                         KAMADA notifies PARI in writing of any objections (on reasonable grounds) to the proposed
                                         appointment:

 

		5.1.1	PARI shall work with KAMADA in
                                         good faith to make available a commercially reasonable change in the provision of the
                                         Services which avoids the use of that proposed sub-processor; and

 

		5.1.2	where such a change cannot be
                                         made within 30 days from PARI’s receipt of KAMADA’s notice, notwithstanding anything
                                         in the CSSA, KAMADA may by written notice to PARI with immediate effect terminate the
                                         CSSA to the extent that it relates to the Services which require the use of the proposed
                                         sub-processors.

 

		5.2	Before any new sub-processor first
                                         processes Controller Personal Data, PARI shall ensure that such sub-processor is capable
                                         of providing the level of protection for Controller Personal Data required by the CSSA
                                         and this Data Processing Agreement; PARI shall ensure that each sub-processor enters
                                         into a data processing agreement as required under Applicable Law.

 

		5.3	PARI shall remain responsible for
                                         all obligations performed and any omission to perform or comply with the provisions under
                                         this Data Processing Agreement by subcontractors to the same extent as if such obligations
                                         were performed or omitted by PARI. PARI shall also remain the KAMADA’s sole point
                                         of contact.

 

		5.4	PARI shall ensure that only such
                                         employees which must have access to the PD in order to meet PARI’s obligations
                                         under this Data Processing Agreement, shall have access to the PD processed on behalf
                                         of KAMADA, and that such employees have received appropriate training and instructions
                                         regarding processing of PD and are subject to a confidentiality undertaking that provides
                                         that he/she must keep all PD secret and may not use it for other purposes not required
                                         for the performance of the tasks he/she may be assigned to in performing the Services.

 

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		6.	AUDIT RIGHTS

 

		6.1	PARI
                                         shall regularly monitor and control compliance of the collection, processing and use
                                         of PD with the CSSA and KAMADA’s instructions. Prior to beginning of the data processing
                                         under this Data Processing Agreement it shall confirm in writing that it has implemented
                                         the technical and organizational measures as set forth in Section ‎3.3 above. PARI
                                         then shall perform a yearly audit of such technical and organizational measures and make
                                         available to KAMADA a copy of the audit report in order to enable KAMADA to monitor compliance
                                         with agreed terms upon KAMADA’s written request. In addition, once a year PARI
                                         shall make available to KAMADA on request all other information necessary to demonstrate
                                         compliance with this Data Processing Agreement.

 

		6.2	If KAMADA reasonably determines
                                         that the yearly audit report is not sufficient to comply with its duty, as a Controller,
                                         to monitor its Processor (e.g. because there was a data breach or because a competent
                                         data protection authority requests it) KAMADA may instruct an auditing company to perform
                                         an external audit of PARI at its own cost, except where the audit reveals non-negligible
                                         non-compliance with this Data Processing Agreement or the Applicable Laws, in which case
                                         PARI shall bear all costs of such audit. Within such audit PARI shall make available
                                         to KAMADA on request all information necessary to demonstrate compliance with this Data
                                         Processing Agreement. It is being understood, that the audit report may contain parts
                                         which have to be kept confidential in which case it shall suffice that auditors declare
                                         that this issue was complied with, unless a competent data protection authority requests
                                         more detailed information. PARI shall also allow audits from data protection authorities
                                         competent for KAMADA.

 

		7.	PERMITTED USES AND DISCLOSURES
                                         OF PHI

 

Unless otherwise limited in this Schedule
3, in addition to any other uses or disclosures permitted or required by this Schedule 3, PARI may:

 

		7.1	make any and all uses and disclosures
                                         of PHI, solely when necessary to provide the Services to KAMADA in accordance with the
                                         CSSA.

 

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		7.2	subject to the terms of Section
                                         5 above, use and disclose to subcontractors and agents the PHI in its possession for
                                         its proper management and administration or to carry out the legal responsibilities of
                                         PARI under the CSSA, provided that any third party to which PARI discloses PHI for those
                                         purposes provides written assurances in advance that: (i) the information will be held
                                         confidentially and used or further disclosed only as required for performance of the
                                         Services; (ii) the information will be used only for the purpose for which it was disclosed
                                         to the third party; and (iii) the third party promptly will notify PARI of any instances
                                         of which it becomes aware in which the confidentiality of the information has been breached;
                                         (iv) subcontractor or agent is subject to audit obligations to ensure that full audit
                                         according to Section 6 can be performed;

 

		7.3	use the PHI and other data for
                                         the sole purpose of monitoring and analyzing the technical performance of the nebulizer
                                         system, but in no event for any other business activity or purpose of PARI.

 

		8.	TERMINATION AND COOPERATION

 

		8.1	Termination. This Schedule 3 terminates
                                         automatically, if the CSSA terminates. In addition, if either party knows of a pattern
                                         of activity or practice of the other party that constitutes a material breach or violation
                                         of this Schedule 3 then the non-breaching party shall provide written notice of the breach
                                         or violation to the other party that specifies the nature of the breach or violation.
                                         The breaching party shall cure the breach or end the violation on or before thirty (30)
                                         days after receipt of the written notice. In the absence of a cure reasonably satisfactory
                                         to the non-breaching party within the specified timeframe, or in the event the breach
                                         is reasonably incapable of cure, then the non-breaching party may, if feasible, terminate
                                         the CSSA, including this Schedule 3.

 

		8.2	Effect of Termination or Expiration.
                                         Within sixty (60) days after the expiration or termination for any reason of the CSSA
                                         or this Schedule 3, PARI shall upon KAMADA’s choice return or destroy all PHI,
                                         if feasible to do so, including all PHI in possession of PARI’s agents or subcontractors.
                                         In the event that PARI determines that return or destruction of the PHI is not feasible,
                                         PARI shall notify KAMADA in writing and may retain the PHI subject to this Section 8.2
                                         if permitted by GDPR. Under any circumstances, PARI shall extend any and all protections,
                                         limitations and restrictions contained in this Schedule 3 to PARI’s use or disclosure
                                         of any PHI retained after the expiration or termination of the CSSA or this Schedule
                                         3, and shall limit any further uses or disclosures solely to the purposes that make return
                                         or destruction of the PHI infeasible.

 

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		9.	INDEMNIFICATION

 

		9.1	PARI will indemnify, hold harmless
                                         and defend KAMADA and its Affiliates and their respective officers, employees and agents
                                         from and against any and all third party, claims and related expenses (including reasonable
                                         attorney fees) resulting from, or arising out of any negligent non-compliance of the
                                         responsibilities of PARI as described in this Data Processing Agreement.

 

		9.2	PARI acknowledges and agrees that
                                         any unauthorized access to, use or disclosure of PD would cause immediate and irreparable
                                         harm for which money damages would not constitute an adequate remedy and that in the
                                         event of any unauthorized use or disclosure of PD, KAMADA shall be entitled to immediate
                                         injunctive relief.

 

		10.	MISCELLANEOUS

 

		10.1	Contradictory Terms; Construction
                                         of Terms. Any other provision of the CSSA that is directly contradictory to one or more
                                         terms of this Schedule 3 (“Contradictory Term”) shall be superseded by the
                                         terms of this Schedule 3 to the extent and only to the extent of the contradiction, only
                                         for the purpose of KAMADA’s and PARI’s compliance with the GDPR, and only
                                         to the extent reasonably impossible to comply with both the Contradictory Term and the
                                         terms of this Schedule 3. The terms of this Schedule 3 to the extent they are unclear
                                         shall be construed to allow for compliance by KAMADA and PARI with the GDPR.

 

		10.2	Survival. Sections 8.2, 10.1,
                                         and this 10.2 shall survive the expiration or termination for any reason of the CSSA
                                         or of this Schedule 3.

 

		10.3	Assignation of rights or obligations.
                                         PARI shall not assign its rights or obligations under this Data Processing Agreement
                                         without the prior written consent of KAMADA. KAMADA shall be entitled to assign its rights
                                         and obligations under this Data Processing Agreement, specifically for the purpose of
                                         conducting clinical studies using third party contractors and processors, other than
                                         PARI.

 

		10.4	Notices. All notices to a party
                                         under this Data Processing Agreement shall be in writing and sent to its address as set
                                         forth at the beginning of this CSSA, or to such other address as such party has provided
                                         the other in writing for such purpose. Notices may be sent by post, courier, fax or email.
                                         Notices shall be deemed to have been duly given (i) on the day of delivery when delivered
                                         in person or by courier, (ii) three (3) business days after the day when the notice was
                                         sent when sent by post, and (iii) on the day when the receiver has manually confirmed
                                         that it is received when sent per fax or email.

 

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IN WITNESS WHEREOF,
the Parties have entered into the CSSA as of the CSSA Effective Date; Schedule 3 will be made an integral part of it:

 

	SIGNED for and on behalf
    of	 	 	 	SIGNED for and on behalf
    of	 	 
	KAMADA Ltd.	 	 	 	PARI Pharma GmbH	 	 
	 	 	 	 	 	 	 
	/s/
    Amir London 	 	 	 	 	 	 
	Amir London	 	Date	 	*****	 	Date
	CEO	 		 	 	 	 
	 	 	 	 	 	 	 
	/s/
    Chaime Orlev 	 	 	 	 	 	 
	Chaime Orlev	 	Date	 	 	 	 
	CFO	 	 	 	 	 	 

 

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Exhibit 1 to Schedule
3

 

Description of
Technical and Organizational Safeguards

 

This Exhibit 1 forms an integral part
of Schedule 3 (Data Processing Agreement)

 

		1.	Physical
                                         access control

 

Are there any regulations governing
access to the building, to the computer centre and to the premises comprising the IT infrastructure?

 

Explanations /
comments: 

 

The physical approach to a data
processing system (“DPS”) must be controlled. Unauthorised persons must be prevented from gaining access to
and operating the DPS in any way.

 

Examples:
- access control system, badge reader

 

- magnetic card, chip card

 

- keys, key allocation

 

- door lock mechanism (electrical
door opener, etc.)

 

- company security, gatekeeper

 

- monitoring facility, alarm
system, video/closed-circuit TV

 

Measures
implemented on Data Processor’s premises:

 

PARI IT infrastructure components are
located in two separated data centres at Moosstraße 3, 82319 Starnberg. Access to these data centres is controlled by E-Token/smartcard
and allowed only to defined persons.

 

SAP infrastructure as well as digital
infrastructure are hosted by QSC AG in Hamburg (contract information available if requested). QSC is audited by PARI QM department.

 

    	Clinical Study Supply Agreement Kamada-PARI
 Effective Date: May 8th, 2019, Version: 1.0
	 30/35

     

    

 

		2.	Computer access
                                         control

 

Are there any regulations
governing the use of DP systems?

 

Explanations /
comments: 

 

Any unauthorised use of DPS
must be prevented, no matter whether or not such use is effected by means of data transmission equipment (e.g. via the internet).

 

		Examples:	- password procedures (including
                                         special characters, minimum length, regular change of password)

 

- automatic blocking (e.g.
password or pausing)

 

- setting up one user master
record per user

 

- encryption of data volumes

 

Measures implemented
on Data Processor’s premises:

 

Use of Laptops/desktops is secured
by E-Token/smartcard and Password; every application needs user and Password authentication.

 

		3.	Data access control

 

Are there any regulations
governing the allocation of user rights, their modification and withdrawal?

 

Explanations /
comments: 

 

It must be ensured that the
authorised persons have access only to those data they are authorised to access. A set of rules for the allocation and withdrawal
of authorisations must be organised and implemented to protect personal data, at all stages of their collection, processing and
use and after their storage, in such a way that they cannot be read, copied, altered or removed by unauthorised persons.

 

    	Clinical Study Supply Agreement Kamada-PARI
 Effective Date: May 8th, 2019, Version: 1.0
	 31/35

     

    

 

		Examples:	- differentiated authorisations
                                         (profiles, roles, transactions, objects), data encryption

 

Measures implemented
on Data Processor’s premises:

 

There must be a written request for
system access and authorisation (documented by Sharepoint workflow) made by GPO’s (Global process owner) or line manager;
they define which role IT adds to a specific person. 

 

All Laptop Harddrives are encrypted
by Bitlocker.

 

The eFlow data are encrypted (transformation:
Rijndael/ECB/NoPadding; Algorithm: AES).

 

		4.	Disclosure control

 

Is the transfer or transmission
of data controlled? Is the dispatch of data volumes (including paper) controlled? Are there any regulations governing the transmission
of sensitive or personal data (passwords, encryption, etc.)? Are there any process-independent plausibility and security checks
in place upon data input by the Data Processor? Are the results checked for correctness by the Controller?

 

Explanations /
comments: 

 

During transport or electronic
transmission, personal data must be protected in such a way that they cannot be read, copied, altered or removed by unauthorised
persons (encryption may be an option). Besides the verifiability and traceability of data transmission it must be ensured that
unauthorised persons are prevented from accessing the data during their transmission. Since this cannot be guaranteed by technical
means at this point, it must be ensured that any modification or deletion of data can be recognised.

 

    	Clinical Study Supply Agreement Kamada-PARI
 Effective Date: May 8th, 2019, Version: 1.0
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		Examples:	- encryption / tunnelling
                                         connection (VPN = Virtual Private Network)

 

- electronic signature

 

- logging

 

- transport protection

 

Measures implemented
on Data Processor’s premises:

 

If somebody wants to have access to
our infrastructure from outside our network, again a specific written request is needed (documented by Sharepoint workflow) and
if allowed implemented by VPN tunnel. 

 

In SAP we have implemented the Standard
SAP Audit Trail as well as an extended Audit Trail. 

 

		5.	Input control

 

Are the collection,
modification and deletion of personal data logged?

 

Explanations /
comments: 

 

It must be ensured (by logging)
that it is possible after the fact to check and ascertain whether personal data have been entered, altered or removed, and if
so, when and by whom.

 

		Examples:	- logging systems and report
                                         evaluation systems

 

Measures implemented
on Data Processor’s premises:

 

See point 4 Audit
Trail and extended Audit Trail

 

		6.	Job control

 

Is it ensured that the data
to be processed by the Data Processor are processed exclusively according to the Controller’s instructions? Are these instructions
implemented by the Data Processor without delay? Are there any checks in place to prevent the data from being copied, altered
or transmitted to unauthorised third parties?

 

    	Clinical Study Supply Agreement Kamada-PARI
 Effective Date: May 8th, 2019, Version: 1.0
	 33/35

     

    

 

Explanations /
comments: 

 

It must be verified and ensured
that personal data processed on behalf of others are processed strictly in compliance with the Controller’s instructions.

 

		Examples:	- obligation of staff involved
                                         in data processing to maintain data secrecy

 

- code of conduct for data
processing by the Data Processor

 

- procedures for revealing
any error instructions

 

- checking compliance with
instructions

 

- granting the Controller
monitoring rights as per data privacy agreement

 

Measures implemented
on Data Processor’s premises:

 

The use of IT Systems is described
in a standard operating procedure of PARI.

 

PARI IT is audited by internal QM department
as well as external audits by cancom/acentrix (detailed audit documentation available if requested).

 

		7.	Availability control

 

Does the Data Processor has
a backup scheme in place and is it checked at regular intervals? Are there any disaster response exercises in place? Is the place
of storage and processing clearly identified? Has the storage period for the data sets and possibly for the software been defined?

 

Explanations /
comments: 

 

The availability of personal
data must be ensured. Appropriate measures are to be taken to protect DPS (hardware and software) against accidental destruction
(disaster case).

 

    	Clinical Study Supply Agreement Kamada-PARI
 Effective Date: May 8th, 2019, Version: 1.0
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		Examples:	- backup procedures

 

- mirror disks, e.g. RAID
procedure

 

- uninterruptible power supply
(UPS)

 

- separate storage

 

- antivirus protection, firewall

 

- contingency plan

 

Measures implemented
on Data Processor’s premises and are described in several standard operation procedures at PARI.

 

Data are hosted by QSC AG; Information
regarding backup procedure etc are available if requested.

 

		8.	Separation control

 

Has the separation control requirement
been fulfilled to ensure the separate processing of data collected for different purposes (separation rule)? Are the systems multi-client
capable?

 

Explanations /
comments: 

 

It must be ensured that personal
data collected for different purposes can be processed separately. Logical rather than physical separation is required.

 

		Examples:	- “internal client
                                         capability” / earmarking

 

- functional separation (production,
testing)

 

Measures implemented
on Data Processor’s premises:

 

Data access is based on different roles
so that the users only see the data they need for work.

 

Relevant system landscape is separated
into Development system, Quality system and Production system.

 

 

 

 

	Clinical
    Study Supply Agreement Kamada-PARI

    Effective Date: May 8th, 2019, Version: 1.0	35/35Exhibit 4.32

 

CERTAIN IDENTIFIED INFORMATION HAS BEEN
EXCLUDED FROM THE EXHIBIT BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY
DISCLOSED.

[*****] indicates the redacted confidential
portions of this exhibit.

 

BINDING TERM SHEET

[*****]®

 

December 6, 2019

 

	Recitals	This Binding Term Sheet (“Term
        Sheet”) summarizes the main terms and conditions under [*****],
        of [*****] (“COMPANY”) and Kamada Ltd. of 2 Holzman St. Science Park, P.O. Box 4801, Rehovot,
        7670402, Israel (“SUPPLIER”) will enter into a long-term agreement for the supply of the Product
        (as defined below) and for the grant of exclusive distribution rights to SUPPLIER in certain territories and ancillary
        agreements. (Each of COMPANY and SUPPLIER is referred to hereunder as a “Party” and together the “Parties”.)

         

        By signing this Term Sheet, the
        Parties agree to be legally bound by the provisions set forth below, and each Party shall be legally bound to proceed
        to negotiate in good faith and then execute the following agreements incorporating the terms set forth herein:

         

        i.
        a Contract Manufacturing and Supply Agreement (the “Supply Agreement”);

        ii.
        a Plasma Supply Agreement (the “Plasma Agreement”);

        iii.
        a Quality Agreement (the “Quality Agreement”);

        iv.
        a Technology Transfer Agreement (the “Technology Transfer Agreement”); and

        v.
        an Exclusive Distribution Agreement (the “Exclusive Distribution Agreement”)

         

        (Each of the agreements listed
        in (i) through (v) above, collectively, the “Definitive Agreements” and individually, a “Definitive
        Agreement”).

         

        The Plasma Agreement, the Quality
        Agreement and the Technology Transfer Agreement will each include a three-way executed annex that will include a detailed
        list of COMPANY, SUPPLIER and [*****]
        (as defined below) roles and responsibilities with respect to the scope of each of those agreements.

         

        The Parties shall make all commercial
        reasonable best efforts to execute the Technology Transfer Agreement within [*****]
        ([*****]) days following the execution
        of this Term Sheet.

         

        The Parties shall make all commercial
        reasonable best efforts to execute the other Definitive Agreements not later than [*****].

         

        The execution of the Definitive
        Agreements is subject to obtaining the approval of the Parties’ respective senior management and Board of Directors.

	Product	The
    pharmaceutical product, [*****]®[*****]
    (the “Product”).
	Territory	Worldwide (other than the Exclusive
        Distribution Territories (as defined below) (the “Territory”).

         

        The “Exclusive Distribution
        Territories” shall mean the territories in respect of which COMPANY shall grant SUPPLIER exclusive distribution
        rights under the Exclusive Distribution Agreement as follows: (a) Israel; (b) the areas or territories administered or
        controlled by Palestinian Authorities which shall be deemed to include the West Bank and Gaza (the “Palestinian
        Territories”); and (c) any other country/ies or territory/ies mutually agreed upon by the Parties. SUPPLIER will
        be solely responsible for obtaining, and the costs associated with, all necessary product registrations and Regulatory
        Approvals in the Exclusive Distribution Territories.

	Subcontractor	Following the written approval
        of COMPANY, SUPPLIER may engage subcontractors to perform specific services and/or obligations under any of the Definitive
        Agreements (each a “Subcontractor”). Unless specifically agreed under any Definitive Agreement(s),
        the SUPPLIER will remain primarily liable to COMPANY for the performance of its Subcontractors performance and obligations
        under the Definitive Agreements.

         

        Without derogating from the foregoing,
        it is hereby agreed between the Parties that for the purposes of this Term Sheet and the Definitive Agreements, [*****]
        (“[*****]”) shall
        be considered to be a Subcontractor of the SUPPLIER for the purpose of the performance of certain Plasma’s fractionation
        services and related services.

 

    1

     

    

 

	Supplier
    Registration and Regulatory Approval	The SUPPLIER, as manufacturer of the
                                                                                                                                                 Product (including, the manufacturing facilities of SUPPLIER and its Subcontractor, [*****]),
                                                                                                                                                 has or will obtain and maintain any and all manufacturing and GMP approvals for its manufacturing facilities as may be
                                                                                                                                                 required by [*****] (the “[*****]”), [*****], or other regulatory
                                                                                                                                                 authorities in the Territory (such required registrations/licenses, the “Supplier Registration”). As used
                                                                                                                                                 herein, the term “Regulatory Approval” shall mean the manufacturing and GMP approvals required in order to
                                                                                                                                                 manufacture or sell the Product, obtained by [*****] and [*****] under current licenses in the Territory, including, but not
                                                                                                                                                 limited to, the Supplier Registration.

         

        In the event that COMPANY wishes
        to register the Product in other territories which will require additional regulatory oversight other than the [*****]
        or [*****] (other than territories that will be covered under the Exclusive Distribution Agreement), then the Parties
        shall negotiate and endeavor to reach an agreement, in good faith, with respect the additional activities that may be
        required, timelines and costs associated with such additional registration. For purposes of clarity, SUPPLIER shall be
        responsible for the costs to obtain Regulatory Approval by the applicable regulatory agency or authority in each of the
        Exclusive Distribution Territories.

	Term	The Supply Agreement shall provide
        for an initial term of twelve (12) years, commencing on the date of the grant of Regulatory Approval by either the [*****]
        or [*****] (the “Supply Agreement Effective Date”), which is projected to be by [*****],
        the expiration date to be [*****], (such
        period, the “Initial Term”); provided however, that the Parties may mutually agree to extend the term
        of the Supply Agreement for consecutive [*****]
        ([*****]) year renewal terms (each
        a “Renewal Term” and together with the Initial Term, the “Supply Agreement Term”),
        by mutual agreement at least [*****]
        ([*****]) months prior to the end of
        the Initial Term or the then current Renewal Term.

         

        Each of the Plasma Agreement and
        the Quality Agreement shall have a commencement date as of the date of its execution and shall remain in effect until
        the later of: (i) the termination of the Technology Transfer Agreement; or (ii) the termination of the Supply Agreement.

         

        The Technology Transfer Agreement
        shall have a commencement date as of the date of its execution and shall remain in effect until Regulatory Approval by
        both the [*****] and [*****] has been obtained by the COMPANY, or until COMPANY chooses not to pursue such approval, unless
        earlier terminated as set forth in this Term Sheet and/or in accordance with the terms of the Technology Transfer Agreement.

	Supply
    Agreement	The Supply Agreement will set
        forth in detail the respective responsibilities and obligations of the Parties (including any regulatory responsibilities
        and requirements) with respect to the manufacture and supply by SUPPLIER to COMPANY of commercial batches of the Product
        (as shall be more fully described in the Supply Agreement, and all references in this Term Sheet to “batches”
        shall refer to commercial batches of the Product, unless otherwise expressly provided herein), including, but not limited
        to, the following:

         

        i.
            [*****] (the “Source Plasma”) – COMPANY shall be responsible for the timely supply of all quantities
        of the Source Plasma required for the manufacturing of the Product. The specific terms of the Source Plasma supply, including
        the specifications therefor and other requirements (including current good manufacturing practices and other applicable
        laws, regulations and standards) to be complied with by COMPANY, will be set forth in the Plasma Agreement.

         

        ii.           Raw Materials – SUPPLIER will be responsible
        for sourcing and qualifying all raw materials (other than the Source Plasma) necessary for production of the Product.

         

        iii.   Raw Materials Storage – SUPPLIER will be obligated to store all raw materials and Source Plasma as required by COMPANY’s
        specifications (as shall be set forth in the Quality Agreement), SUPPLIER’s standard operating practices and applicable
        regulatory standards.

         

        iv. 
        [*****]Testing of Product – The COMPANY will be responsible for the performance of the [*****]
        testing of the Product at its own cost.

        

 

    2

     

    

 

	 	v.
          Rolling Forecast – The COMPANY shall be required to provide a [*****]
        ([*****]-month rolling forecast
        for the Product (“Rolling Forecast”) on a monthly basis, with the first [*****]
        ([*****]) months of each Rolling
        Forecast being binding (the “Binding Forecast”), and the COMPANY shall issue purchase orders for the quantities
        of the Product in the Binding Forecast. The first Rolling Forecast shall be submitted to SUPPLIER one (1) year prior to
        the expected Supply Agreement Effective Date, but shall not be binding on either Party until the Supply Agreement Effective
        Date. The first Binding Forecast shall be effective as of the Supply Agreement Effective Date. The COMPANY shall provide
        SUPPLIER with purchase orders for the naked filled vials of the Product not less than [*****]
        ([*****]) months prior to the
        required delivery date, and for final packed vials not less than [*****]
        ([*****]) months prior to the
        required delivery date.

                                                                                                                                                  

        In addition, upon termination
        of the Supply Agreement, other than as a result of COMPANY’s uncured material breach, or as a result of SUPPLIER’s
        inability to supply the Product due to force majeure (as shall be defined in the Supply Agreement), COMPANY shall have
        the right, but not the obligation, to order up to [*****]
        ([*****]) additional batches of
        the Product in accordance with the then applicable Rolling Forecast, subject to the timely supply by COMPANY of the required
        quantities of Source Plasma.

         

        vi.  
        Minimum Commitment – During the Supply Agreement Term, COMPANY will be obligated to acquire and SUPPLIER will be
        obligated to supply a minimum of [*****]
        ([*****]) [*****]
        of the Product per year for each of the first five full calendar years of the Initial Term, and [*****]
        ([*****]) batches of the Product
        per year for the remaining [*****] years
        of the Initial Term (“Minimum Annual Commitment).  In the event that COMPANY fails to order the Minimum Annual
        Commitment in a given year, then the COMPANY will be obligated to pay SUPPLIER an amount equal to [*****]%
        of the Supply Price per each of the batches not ordered under the Minimum Annual Commitment.

         

        vii.
         Batch Size – The current batch size is [*****]
        of Source Plasma.

         

        viii. Supply Price – The price payable by COMPANY to the SUPPLIER per batch of the Product supplied shall be as follows
        (the “Supply Price”):

         

        a. $[*****][*****]per
        batch; and

        b. $[*****][*****]per
        batch for the incremental batches supplied in a given year in excess of the 1st 12 batches.

         

        Delivery of the Product
        will be made [*****] (Incoterms 2010)
        [*****][*****][*****]in [*****].

         

        The Supply Price does
        not include costs associated with Source Plasma (covered under the Plasma Agreement), [*****]
        and batch release services as may be required to release the Product, except in [*****].

         

        COMPANY will be responsible
        for Product Qualified Person batch release in [*****] and all costs associated with it. In the event that COMPANY wishes
        SUPPLIER to provide with the Product Qualified Person batch release in [*****], then COMPANY shall reimburse SUPPLIER for
        all of its costs and expenses associated with such additional service.

         

        Payment shall be made
        by COMPANY in full within [*****] ([*****])
        days from the date of SUPPLIER’s invoice.

         

        ix.  
        Supply Price Adjustment – As of [*****],
        and at the beginning of every calendar year thereafter, the Supply Price will be increased on an annual basis by the lower
        of: (a) [*****]; or (b) [*****]%.

         

        In addition, in case
        of substantial change in the cost to SUPPLIER to manufacture and supply the Products under the Supply Agreement due
        to statutory or regulatory changes or a change in the specifications of the Product, or due to other changes, such as
        significant increase in cost of raw material or cost of activities subcontracted, SUPPLIER will provide such documentation
        for such increases as COMPANY may reasonably request and the Parties agree to negotiate and endeavor to reach agreement
        in good faith regarding adjustment (increase) to the Supply Price.

        

 

    3

     

    

 

	 	x.
           Production failure –The COMPANY will become obligated to pay the Supply Price for a Product batch upon initiation
        of the first step of the production process by SUPPLIER (i.e. thawing of plasma), even in case the production or manufacture
        of such batch is not completed either at the direction of the COMPANY or as a result of the termination of the Supply
        Agreement following a default by COMPANY; provided, however, that if a batch of Product shall fail to meet the specifications
        for the Product, and an independent mutually agreed laboratory shall determine that the batch failure was through the
        fault of SUPPLIER, then the SUPPLIER will replace the failed batch at SUPPLIER’s cost, following the supply by the
        COMPANY of Source Plasma required for such replacement batch.

         

        In the event that the total number of failed
        batches in a given calendar year exceed [*****]
        ([*****]), then SUPPLIER will
        reimburse COMPANY for the value of the Source Plasma, included in each of the failed batches over the first [*****]
        ([*****]) failed batches. SUPPLIER’s
        responsibility to reimburse COMPANY for the costs of the Source Plasma will be capped at [*****]%
        of Supplier’s annual sales from supply Product to the COMPANY.

         

        xi.
          Yields – Current estimated batch yields based in [*****]
        process – [*****]vials.

         

        The Parties will negotiate
        in good faith the mechanism of determination pricing modifications (increase or decrease) in relation to batch yields.
        Such negotiations will be initiated following the manufacturing and supply of the first [*****]
        ([*****]) batches (excluding [*****]
        (“[*****]”) batches)
        by SUPPLIER, and will be based on actual data resulting from the manufacturing of those batches.

         

        xii.  Art Work – The COMPANY shall be required to provide SUPPLIER with the artwork and labeling specifications for the
        Product at its own cost and in coordination with SUPPLIER preferred vendors.

         

        xiii. Back-Up Supplier –COMPANY shall be entitled to qualify an alternative supplier of the Product (“Back-Up
        Supplier”) solely for the purpose of supplying Product to COMPANY in the event that SUPPLIER is unable to supply
        the Product in the circumstances and subject to the conditions set forth below. SUPPLIER agrees to reasonably cooperate
        with COMPANY, at COMPANY’s expense, to transfer to such Back-Up Supplier or reasonably assist with the replication
        by such Back-Up Supplier of [*****] manufacturing
        technology, know-how and trade secrets that have been transferred to SUPPLIER pursuant to the Technology Transfer Agreement
        and are used by SUPPLIER in the manufacture of the Product, for the limited purposes set forth in this subsection, provided
        that reasonable and customary written undertakings from such Back-Up Supplier are in place to protect SUPPLIER’s,
        the COMPANY’s, and any third-party’s confidential and proprietary information and to ensure compliance by
        such Back-Up Supplier with any obligations of SUPPLIER under any license with respect to any manufacturing technology,
        know-how and trade secrets transferred.

         

        In the event that SUPPLIER
        is unable to supply the Product during a consecutive period of [*****]
        ([*****]) months after the scheduled
        delivery date of the Product (except due to the failure of COMPANY to supply Source Plasma or any other fault of the COMPANY),
        the COMPANY may utilize the services of such Back-Up Supplier until such time as the SUPPLIER resumes production and delivery
        of the Product, and the quantities of Product supplied by such Back-Up Supplier shall be deemed to have been supplied
        by SUPPLIER for the purposes of the Minimum Annual Commitment.

         

        The cost payable to
        SUPPLIER for such technology transfer will be specified in a separate work order.

         

        xiv.
        Joint Steering Committee – the COMPANY, SUPPLIER and [*****]
        will form a joint steering committee including representatives of each entity which will oversee all activities
        during the Term of the Supply Agreement (“JCT”). The JCT will meet as needed but not less than on a quarterly
        basis.

 

    4

     

    

 

	 	
        xv.  Termination – In the event of Termination of the Supply Agreement by COMPANY during the Initial Term, other than
        as a result of SUPPLIER’s material and uncured breach of its obligations under the Supply Agreement, then in addition
        to all other remedies agreed upon, and subject to SUPPLIER and/or [*****]
        provides such documentation to support the actual CAPEX Investment (as such term is defined under the Technology
        Transfer Agreement) made through such termination, the COMPANY will be obligated to compensate SUPPLIER and/or [*****]
        for [*****]% of the CAPEX Investment
        (as such term is defined under the Technology Transfer Agreement) up to an amount of [*****] on a Pro-Rata basis. For clarification, the [*****]
        represents the [*****]% portion
        of the CAPEX Investment.

         

        An example is below
        for clarification:

         

        In the event the Supply
        Agreement is terminated at the end of its fourth year than COMPANY will be required to pay the that portion that represents
        the balance of the Initial Term; [*****] of
        the [*****]years: [*****]
        × [*****] = [*****]

         

        xvi. The Supply Agreement shall contain representations, warranties, covenants, indemnification obligations, insurance commitments,
        limitation of liability and other provisions that are customary for manufacture and supply agreements.

	Plasma
    Agreement	The Plasma Agreement will set
        forth in detail the respective responsibilities and obligations of the Parties (including any regulatory responsibilities
        and requirements) with respect to the supply by COMPANY to SUPPLIER of Source Plasma, including, but not limited to, the
        following:

         

        i.
           The Source Plasma – COMPANY shall be responsible for the timely supply of all quantities of the Source Plasma required
        for the manufacturing of the Product, whether under the Supply Agreement, the Technology Transfer Agreement and/or the
        Exclusive Distribution Agreement (as applicable). COMPANY shall bear all costs associated with the procurement and delivery
        of the required quantities of the Source Plasma indicated in the binding purchase order and will make such quantities
        available in the location designed by SUPPLIER, at least [*****]
        months in advance of each scheduled Product delivery date. COMPANY shall deliver the Source Plasma and any COMPANY-supplied
        components (to be specified in the Plasma Agreement) to the location designated by SUPPLIER [*****]
        (Incoterms 2010), In the event that SUPPLIER and/or [*****]
        support is required with respect to shipment and/or delivery of the Source Plasma, then SUPPLIER and/or [*****]
        will be entitled for reimbursement of its costs associated with such activities.

         

        ii.
           Excess Plasma – COMPANY agrees to allow SUPPLIER and its Subcontractor to utilize excess fractionated plasma (of
        the supplied Source Plasma), free of charge, to further process into products and potentially resell. Save for any liability
        for defective or any other non-conforming Source Plasma supplied by COMPANY, COMPANY will not be responsible for any liability,
        or regulatory and reporting requirements in connection with products that are produced from such excess plasma. COMPANY
        will provide SUPPLIER or its Subcontractor with information related to the Source Plasma supplied by the COMPANY to the
        extent required for submission to any regulatory authorities, or under applicable laws, regulations or rules, and/or otherwise
        required for the exercise of SUPPLIER’s rights and/or fulfillment of any of its obligations under the Definitive
        Agreements. SUPPLIER will fairly compensate COMPANY for the information related to the Source Plasma and time to support
        such activities above a minimal level which will be defined in the Plasma Agreement.

         

        iii.
        The Plasma Agreement shall contain representations, warranties, covenants, indemnification obligations, insurance commitments,
        and limitation of liability provisions and other provisions that are customary for agreements of this kind.

         

        iv. 
        COMPANY responsibility with respect to [*****]
        or any other third party Source Plasma supplier cooperation – COMPANY shall use commercially reasonable best
        efforts to obtain the support of [*****]
        or any other third party Source Plasma supplier as may be needed to ensure: (a) Adequate supply of Source Plasma to ensure
        Source Plasma availability at [*****]
        at least [*****] weeks in advance of
        the relevant scheduled manufacturing start date. (ii) Supplies of the Source Plasma in a refrigerated container and provides
        the associated electronic shipment notice detailing all relevant Source Plasma unit information (Electronic Bleeding List),
        and (iii) Responsibility for the initiation of the look-back handling.

 

    5

     

    

 

	 	v.
                                           Complaints – the Plasma Agreement will include a reference to a complaints mechanism
                                         as will be further defined under the Quality Agreement.

 

vi.  Three
Way Annex – The Plasma Agreement shell include a three-way executed annex that will include a detailed list of COMPANY,
SUPPLIER and [*****] roles and responsibilities with respect to the Supply and handling of the Source Plasma.

 

vii. The
Plasma Agreement shall contain representations, warranties, covenants, indemnification obligations, insurance commitments, limitation
of liability and other provisions that are customary for supply agreements.

	Technology
    Transfer Agreement	The Technology Transfer Agreement
        will set forth in detail the respective responsibilities and obligations of the Parties (including any regulatory responsibilities
        and requirements) with respect to technology transfer and other services with respect to the Product, Product manufacturing
        qualification and Regulatory Approval by the [*****] and/or [*****], including, but not limited to, the following:

         

        i.     Transition/qualification of Product manufacturing – SUPPLIER shall use commercially reasonable best efforts to work
        with COMPANY and [*****] in order to
        transition and qualify the Product manufacturing from [*****]
        to SUPPLIER and its Subcontractor, [*****],
        with a target date for obtaining Regulatory Approval by the [*****] and [*****].

         

        COMPANY shall use commercially
        reasonable best efforts to obtain the support of [*****]
        as may be reasonably needed to facilitate the technology transfer process and meet defined timelines.

         

        ii.    Regulatory Approval – The Parties acknowledge that the COMPANY requires that the Regulatory Approval by both the
        [*****] and [*****] be obtained by [*****].
        The Parties will finalize a detailed timeline for all required activities, which would be included as an annex to the
        Technology Transfer Agreement.

         

        Each of the SUPPLIER
        and COMPANY shall make commercially reasonable best efforts to meet the timelines as will be set forth in the Technology
        Transfer Agreement for obtaining such Regulatory Approval.

         

        In the event of (a)
        a delay in the technology transfer activities or timelines due to COMPANY responsibility or otherwise due to [*****]
        inability to cooperate; and/or (b) COMPANY does not obtain the Regulatory Approval by the [*****] or [*****] (or
        by both of them) by [*****]; and/or (c) based
        on discussions with the [*****] and/or [*****], such Regulatory Approval is not expected to be obtained by [*****],
        through no fault of SUPPLIER, then, since the technology transfer costs and activities referred to herein are based on
        assumptions made with respect to such timelines and the required activities; the Parties shall negotiate and endeavor
        to reach agreement, in good faith, with respect the additional activities that will be required (i.e. clinical trials,
        process changes etc.), adjusted timelines and actual and reasonable costs which shall be supported by appropriate documentation.

         

        iii.   Technology Transfer Services – The technology transfer services shall be described in the Technology Transfer Agreement
        (the “Technology Transfer Services”), and will include all labor associated with development, engineering,
        qualification, manufacturing and supply of up to [*****]
        batches of Product, methods transfer, project management and other necessary services. The Technology Transfer
        Services do not currently include the following:

         

        a.
        [*****]; and

        b.
        [*****]

        c.
  Any Post-Approval commitments required by the [*****],
[*****], or the applicable regulatory agency or authority in any other country or territory

         

        The addition of these
        activities, if required, will be done under a separate work order.

 

    6

     

    

 

	 	
        iv.          [*****] of Product – The COMPANY
        will be responsible for the performance of the [*****]
        of the Product at its own cost.

         

        v.         [*****] Support – The COMPANY is
        responsible for any costs or payment to be made to [*****]for
        its support and/or services related to this project and/or for the grant of its approval or license with respect to the
        transfer to SUPPLIER of [*****]Product
        manufacturing technology, know-how and trade secrets (including analytical methods). [In addition, COMPANY is responsible
        to ensure that [*****]shall provide SUPPLIER
        analytical services beyond [*****] as
        a back-up, in case there is a delay in the technology transfer of the analytical methods and/or their validation. Such
        analytical services may comprise full product release services, or alternatively, outsourcing of certain of the testing. 

         

        vi.   Cost of Services – The COMPANY shall pay SUPPLIER a total amount of $[*****]
        for the provision of the Technology Transfer Services in accordance with the following payment schedule:

         

        a.    During [*****]–[*****]equal
        quarterly payments of $[*****]each, payable
        on the 1st day of every calendar quarter;

        b.    During [*****]–[*****]equal quarterly payments
of $[*****]each, payable on the 1st day of every calendar quarter;

        c.    During [*****]–[*****]equal quarterly payment
of $[*****]each, payable on the 1st day of every calendar quarter;

        d.    Upon
[*****]– a one-time payment of $[*****]payable within [*****] days of obtaining such approval; and

        e.    Upon [*****]– a one-time payment of $[*****]payable
within [*****]days of obtaining such approval.

         

        All travel, equipment
        purchase and installation costs, audit costs (associated with regulatory agency pre-approval inspections), internal hours
        and consultants required by SUPPLIER or Subcontractor and materials, excluding plasma, are also covered by the quarterly
        technology transfer payment set forth above.

         

        vii.  CAPEX Investment – COMPNAY acknowledge that in addition to the agreed upon technology transfer costs specified above,
        [*****] requires to make certain immediate
        CAPEX investments in order to be able to support the technology transfer and future planned manufacturing.

         

        viii.  Termination - COMPANY retains the right to terminate the Technology Transfer Agreement by written notice to SUPPLIER if
        the technology transfer contemplated therein is not feasible for any reason to be set forth in such notice, which may
        include, without limitation, technical challenges, regulatory agency requirements for significant changes and/or clinical
        studies or any other reason that may make commercialization of the Product impractical. COMPANY will be required to pay
        a final quarterly payment for the quarter in which the decision was notified to SUPPLIER. In the event that the Parties
        fail to execute the Supply Agreement in the date set forth above under the Recitals, other than as a result of SUPPLIER’s
        material and uncured breach of its obligations under this Term Sheet or the Technology Transfer Agreement, and as a result
        thereof, the Technology Transfer Agreement is terminated, then COMPANY will pay SUPPLIER pursuant to subsection (v) above
        (pro-rata) for all Technology Transfer Services performed until the effective date of termination of the Technology Transfer
        Agreement.

         

        In addition to the above,
        in any event of termination of the Technology Transfer Agreement, and subject to SUPPLIER and/or [*****]
        provides such documentation to support the actual CAPEX Investment made through such termination, then the COMPANY
        will be obligated to compensate SUPPLIER and/or [*****]
        for [*****]% of the CAPEX Investment
        (as such term is defined under the Technology Transfer Agreement) up to the amount of €[*****]
        ([*****]). For clarification,
        the €[*****]represents the [*****]%
        portion of the CAPEX Investment.

         

        In the event that the
        COMPANY terminates the Technology Transfer Agreement, the Supply Agreement will terminate automatically and become null
        and void.

 

    7

     

    

 

	 	viii. Three Way Annex – The Technology Transfer Agreement shall include a three-way executed
                                         annex specifies a detailed list of COMPANY, SUPPLIER and [*****] roles and responsibilities
                                         with respect to the technology transfer activities.

 

ix.   Joint
Steering Committee – the COMPANY, SUPPLIER and [*****] will form a joint steering committee including representatives of
each entity which will oversee all activities related to the Technology Transfer Agreement and the three-way executed annex during
the term of the Technology Transfer Agreement. The Joint Steering Committee will meet as needed but not less than on quarterly
basis.

 

x.    The
Technology Transfer Agreement shall contain representations, warranties, covenants, indemnification obligations, insurance commitments,
limitation of liability and other provisions that are customary for manufacture and supply agreements.

	Exclusive
    Distribution Agreement 	The Exclusive Distribution Agreement
        will set forth in detail the respective responsibilities and obligations of the Parties (including any regulatory responsibilities
        and requirements) with respect to the grant by COMPANY to SUPPLIER of exclusive marketing and distribution rights with
        respect to the Product in the Exclusive Distribution Territories, including, but not limited to, the following:

         

        i.   
        Exclusive Marketing & Distribution Rights - COMPANY shall grant to the SUPPLIER the exclusive rights to market and
        distribute the Product in Israel and the Palestinian Territories during the period of the Supply Agreement.

         

        Following obtaining
        of Regulatory Approval by the [*****] or [*****], the Parties shall discuss and endeavor to reach agreement, in good faith,
        regarding the possibility of a grant of additional exclusive marketing and distribution rights to SUPPLIER in other territories
        in the Territory, it being understood that COMPANY may, at its sole option decline to expand such exclusive distribution
        and marketing rights.

         

        ii.    Regulatory approval in such territories - SUPPLIER will be solely responsible for the costs of manufacturing the Product
        for Israel and Palestinian Territories and if applicable, for other Exclusive Distribution Territories, (it being agreed
        that the costs of the Source Plasma shall be covered under the Plasma Agreement) and will incur full responsibility for
        the regulatory and operating requirements for the Product in Israel and the Palestinian Territories and if applicable
        in other Exclusive Distribution Territories.

         

        COMPANY shall co-operate
        with and assist SUPPLIER as required by SUPPLIER, but at SUPPLIER’s cost, in order to obtain Regulatory Approval
        by the applicable regulatory agency or authority in each of the Exclusive Distribution Territories, including, without
        limitation, by permitting access to and/or use of information in the COMPANY’s Product dossier and drug master file
        (including the right to cross-reference any Product regulatory approvals and/or registrations). SUPPLIER shall be required
        to build its forecasts for Product into the COMPANY’s overall demand plan for the Product by cooperating with COMPANY
        in the creation of the forecasts. COMPANY shall not be responsible for the remainder of any batch if SUPPLIER orders Product
        outside of COMPANY’s demand plan.

         

        SUPPLIER shall market
        the Product under the name [*****]®
        in the Exclusive Distribution Territories. The Exclusive Distribution Agreement shall include a license section to allow
        for SUPPLIER’s limited use of the tradename [*****]®
        in the Exclusive Distribution Territories.

         

        iii.   Consideration - SUPPLIER agrees to pay COMPANY a [*****]%
        royalty on net sales (to be defined in the Exclusive Distribution Agreement) of the Product in Israel and the Palestinian
        Territories, and if applicable, in other Exclusive Distribution Territories, payable quarterly for the duration of the
        Exclusive Distribution Agreement.

         

        iv.   The Exclusive Distribution Agreement shall contain representations, warranties, covenants, indemnification obligations,
        insurance commitments, and limitation of liability provisions and other provisions that are customary for exclusive distribution
        agreements.

 

    8

     

    

 

	 	v.    COMPANY will supply the Product for distribution by SUPPLIER under the Exclusive Distribution
                                         Agreement.

 

SUPPLIER agrees to purchase
such quantities of unlabeled finished goods from the COMPANY with a [*****]% markup on the COMPANY’s actual acquisition
costs plus shipping expenses and shipping insurance costs. Actual acquisition costs will include the actual cost of the plasma
plus the actual cost of the of batch production and any additional costs associated with the batch (potency testing and release)
divided by the total number of vials produced in that actual batch. An example is below for clarification:

 

[*****]

 

vi. The
Exclusive Distribution Agreement shall contain representations, warranties, covenants, indemnification obligations, insurance
commitments, limitation of liability and other provisions that are customary for manufacture and supply agreements.

	Exclusivity	COMPANY shall exclusively purchase
        all of its requirements of the Product for sale in the Territory from SUPPLIER except as shall be permitted under the
        Supply Agreement with respect to purchases of Product from a Back-Up Supplier. SUPPLIER shall manufacture the Product
        exclusively for COMPANY and shall not manufacture or develop for sale, for SUPPLIER or any third party, any [*****]product.

         

        This section shall be subject
        to applicable antitrust laws.

	Confidentiality	The
    terms of the Mutual Confidentiality Agreement entered into between [*****]
    (of [*****]) and SUPPLIER effective
    as of [*****] (the “CDA”), are
    incorporated herein by reference, and will apply to any and all discussions and Confidential Information (as defined in the
    CDA) exchanged by the Parties under this Term Sheet and/or any Definitive Agreements as contemplated herein, in any form,
    whether oral, written, electronic or otherwise. In addition, the “Purpose” as defined in the CDA shall be deemed
    to include discussions between the Parties with respect to the terms of this Term Sheet and the Definitive Agreements and
    with respect to the transactions contemplated herein. Without derogating from the foregoing, neither Party shall disclose
    or discuss the terms of this Term Sheet with any persons other than its representatives who have a “need to know”
    and who are bound by similar confidentiality and non-use obligations, without the prior written approval of the other Party.  The
    confidentiality and non-use obligations of the Parties herein shall continue for the period/s set forth in the CDA.  The
    COMPANY acknowledges that SUPPLIER is a public company whose shares are publicly traded on the Tel-Aviv Stock Exchange and
    the NASDAQ. Accordingly: (a) SUPPLIER’s confidential information, as well as this Term Sheet may be considered as “inside
    information” pursuant to Israeli and US securities laws and regulations and the COMPANY undertakes not to use any confidential
    information in violation of the applicable securities laws; and (b) SUPPLIER may be required to make certain disclosures and
    publications under applicable laws, which may include this Term Sheet and/or the Parties’ discussions, such disclosure
    not to be deemed a breach of this Term Sheet, the Definitive Agreements and related agreements. This provision shall survive
    the termination or expiration of this Term Sheet for any reason.
	Public
    Announcement	Notwithstanding
    the foregoing, if an announcement concerning this Term Sheet, and the Definitive Agreements is required by applicable law
    or any listing agreement with a national securities exchange or quotation system, the Party required to make such announcement
    may do so, provided that such Party shall provide notice to and a copy of such announcement as promptly as practicable in
    advance of such announcement and, to the extent practicable, take the views and comments of the other Party in respect of
    such announcement into account prior to making such announcement. Following the execution of this Term Sheet, COMPANY shall
    inform SUPPLIER of its decision regarding the identification of its name under the public announcement.
	Expenses	Each
    Party shall bear its own expenses, including fees and expenses of legal, regulatory and financial advisors, in connection
    with the negotiation and execution of this Term Sheet, the Definitive Agreements and any ancillary agreements.

 

    9

     

    

 

	Termination	If the Definitive Agreements are
        not executed by the Parties within the timelines specified above, notwithstanding their reasonable commercial best efforts,
        then such period shall be extended automatically for an additional [*****]
        ([*****]) day period, during which
        period the Parties shall continue to make reasonable commercial best efforts to finalize and execute the Definitive Agreements.
        Upon the earlier of the expiration of such additional [*****]
        ([*****]) day period or the execution
        of the Definitive Agreements, this Term Sheet shall terminate automatically and will be null and voided, except any terms
        hereof that are expressly provided herein or intended by the Parties to survive the termination hereof.

         

        In the event of such termination,
        COMPANY will be required to reimburse SUPPLIER for any costs incurred by Supplier with respect to initial Technology Transfer
        activities performed during such period. In no event, such costs will be in excess of the amount defined above as the
        payment due on account of Technology Transfer Services for the year [*****],
        on a pro-rata basis.

	Governing
    law and jurisdiction; miscellaneous	This Term Sheet shall be governed
        by and construed in accordance with the laws of [*****],
        without regard to the conflicts of law principles thereof and the competent state or federal courts located in [*****]
        shall have exclusive jurisdiction with respect to any disputes or actions arising from this Term Sheet.

         

        This Term Sheet may be executed
        in one or more counterparts, and by Parties in separate counterparts, each of which when so executed shall be deemed an
        original, but all of which together shall constitute one and the same instrument. This Term Sheet, to the extent signed
        and delivered by electronic means, shall be treated in all manner and respects as an original agreement or instrument
        and shall be considered to have the same binding legal effect as if it were the original signed version thereof delivered
        in person.

         

        Any amendments or modifications
        to this Term Sheet must be in writing and signed by duly authorized representatives of both of the Parties.

	Assignment	Neither Party shall assign or
        otherwise transfer this Term Sheet or any of its rights and obligations hereunder without the prior written consent of
        the other Party, which shall not be withheld or delayed unreasonably.

         

        Notwithstanding the foregoing,
        either Party shall not be restricted in any way from assigning this Term Sheet or any of the Definitive Agreements to
        any affiliate, or in connection with any sale or transfer of all or substantially all of the assets to which the Supply
        Agreement relates, or in connection with any change of control.

 

 

[Signature Page Follows]

 

    10

     

    

 

Executed by the Parties:

 

	COMPANY	 	SUPPLIER
	 	 	 
	By:	 	 	By:	/s/ Amir London
	Name: 	[*****]	 	Name: 	Amir London
	Its:	[*****]	 	Its:	CEO
	Date:	 	 	Date:	 
	 	 	 
	 	 	By:	/s/ Amir London
	 	 	Name:	Chaime Orlev
	 	 	Its:	CFO
	 	 	Date:

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