Document:

EXHIBIT
10.39(b)

 

AMENDMENT
No. 2 

TO
SPONSORED RESEARCH AGREEMENT

 

This
Amendment No. 2 to the Sponsored Research Agreement (“Amendment”) is made and entered into as of October 18, 2021 by and
between Cell Source Limited (“Cell Source”) and The University of Texas M.D. Anderson Cancer Center (“MD Anderson”),
a member institution of The University of Texas System (“System”).

 

RECITALS

 

	A.	Cell
    Source and MD Anderson entered into a Sponsored Research Agreement dated November 28, 2018 (the “Agreement”), which was
    amended on December 2nd, 2020.
	 	 
	B.	Cell
    Source and MD Anderson wish to amend the terms of the Agreement as set forth below.

 

NOW,
THEREFORE, it is hereby agreed as follows:

 

	 	1.	The
    term of the agreement will be extended by one year, commencing on November 28th, 2021 through November 27th,
    2022.
	 	2.	Exhibit
    A of the Agreement shall include, as replacement and update to Exhibit A, the Exhibit attached hereto which describes the Work Plan
    for the Year starting 28th of November 2021 and ending 27th of November 2022.

 

	1.	Exhibit
    B of the Agreement shall include, as replacement and update to Exhibit B, the Exhibit attached hereto which describes the budget
    for the Year starting 28th of November 2021 and ending 27th of November 2022. As per the amended budget, the quarterly
    payments for the coming year will be $324,000 per quarter.
	 	 
	2.	Except
    as expressly provided in this Amendment, all other terms, conditions and provisions of the Agreement shall continue in full force
    and effect as provided therein.

 

IN
WITNESS WHEREOF, Cell Source and MD Anderson have entered into this Amendment effective as of the date first set forth above.

 

	CELL
    SOURCE 	 	THE
    UNIVERSITY OF TEXAS
	 	 	 	M.D.
    ANDERSON CANCER CENTER
	 	 	 	 	 
	By	/s/ Itamar Shimrat	 	By	/s/
    Amy M. Moritz
	 	Itamar
    Shimrat	 	Name	Amy
    M. Moritz
	 	Chief
    Executive Officer	 	Title	Assistant
    Director ORA
	 	 	 	 	 
	Date:	October
    25, 2021	 	Date:	10/25/2021
	 	 	 	 	 
	 	 	 	 	Read
    & Understood:
	 	 	 	 	 
	 	 	 	 	/s/Yair
    Reisner
	 	 	 	 	Principal
    Investigator

 

    	 

     

    

 

Amended
Exhibit A

 

Work
plan for Cell Source: 28 November 2021 – 27 November 2022*

 

1.
Studies with human cells :

 

A. Human
VETO-project: Optimize transfection of our anti-viral veto cells with GMP grade CD19 vector from Orgenesis or from other
companies.

 

1.
Test the efficacy of anti-CD19 VETO-CAR T cells in vitro against CD19 tumor cells.

2.
Test the efficacy of anti-CD19 VETO-CAR T cells in NSG mice bearing CD19 positive leukemic cells.

3.
Compare the efficacy of VETO-CAR to regular CAR T cells in NSG mice.

4.
Test the veto activity of VETO-CAR T cells compared to non-transduced VETO cells.

5.
Characterize the genetic signature of our anti-viral Tcm by SCRNAseq.

6.
Compare the efficacy of Tcm VETO-CAR to Effector memory VETO-CAR T cells in NSG mice.

 

B. Investigate
the potential use of Veto cells directed against PR1 antigen expressed on AML tumor cells (in collaboration with Jeff Moldrem
Lab).

 

1.
Attempt to generate veto cells from donors vaccinated against PR1.

2.
Test anti-PR1 veto cells for their activity against AML blasts in vitro and in-vivo.

 

C. Routine
testing of immune reconstitution and immune tolerance induction in patients undergoing transplantation in our clinical
trial.

 

2.
Mouse studies:

 

A.
Investigate the potential role of Tcm plus BM in the treatment of MS.

 

B.
Generating Tcm against the WT1 Tumor antigen following immunization of mouse donors with WT1 peptides.

 

1.
Optimize conditions for immunization

2.
Optimize killing of WT1 tumors in-vitro and in-vivo.

 

C.
Continue to investigate potential evasion of Tcm from NK mediated killing

 

*
The proposed plan might be changed according to progress, and therefore, while some aims will be intensively investigated,
others might not be performed.

 

    	 

     

    

 

Amended
Exhibit B

 

Budget

 

	Personnel	 	Base
    Salary	 	 	Cal
    Mths.	 	 	Effort	 	 	Salary	 	 	Fringe	 	 	Total	 	 	Grand
    Total	 
	PI	 	$	346,337.00	 	 	 	12.00	 	 	 	23	%	 	$	79,657.51	 	 	$	22,304.10	 	 	$	101,961.61	 	 	$	101,961.61	 
	Scientific Mgr	 	$	133,128.00	 	 	 	12.00	 	 	 	100	%	 	$	133,128.00	 	 	$	37,275.84	 	 	$	170,403.84	 	 	$	170,403.84	 
	Research Scientist	 	$	72,275.00	 	 	 	12.00	 	 	 	100	%	 	$	72,275.00	 	 	$	20,237.00	 	 	$	92,512.00	 	 	$	92,512.00	 
	Research Scientist	 	$	64,631.00	 	 	 	12.00	 	 	 	50	%	 	$	32,315.50	 	 	$	9,048.34	 	 	$	41,363.84	 	 	$	41,363.84	 
	Lab Technician	 	$	35,123.00	 	 	 	12.00	 	 	 	50	%	 	$	17,561.50	 	 	$	4,917.22	 	 	$	22,478.72	 	 	$	22,478.72	 
	Graduate Student	 	$	32,000.00	 	 	 	12.00	 	 	 	100	%	 	$	31,539.50	 	 	$	8,831.06	 	 	$	40,370.56	 	 	$	40,370.56	 
	Salary Total	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	$	469,090.57	 	 	$	469,090.57	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Equipment
                                            or software

                                                    Computer

                                                    Consultant
                                            Costs
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 

 

	Total	 	$	469,090.57	 	 	$	469,090.57	 
	 	 	 	 	 	 	 	 	 
	Supplies	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 
	Reagents, antibodies, pippettes, misc lab supplies	 	$	235,909.43	 	 	$	235,909.43	 
	Animal cost & Maintenance	 	$	80,000.00	 	 	$	80,000.00	 
	 	 	 	 	 	 	 	 	 
	Travel (Domestic)	 	$	5,000.00	 	 	$	5,000.00	 
	Travel (International)	 	$	10,000.00	 	 	$	10,000.00	 
	 	 	 	 	 	 	 	 	 
	Total	 	$	330,909.43	 	 	$	330,909.43	 
	 	 	 	 	 	 	 	 	 
	Other Direct Costs	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 
	Total	 	$	-	 	 	$	-	 
	 	 	 	 	 	 	 	 	 
	Direct Costs	 	$	800,000.00	 	 	$	800,000.00	 
	Indirect Cost 62%	 	$	496,000.00	 	 	$	496,000.00	 
	Total Costs	 	$	1,296,000.00	 	 	$	1,296,000.00EXHIBIT
10.63(a)

 

EIGHTH
AMENDMENT TO

RESEARCH
AND LICENCE AGREEMENT

(this
“Amendment”)

 

Effective
Date: December 2, 2021

 

by
and between

 

YEDA
RESEARCH AND DEVELOPMENT COMPANY LIMITED

a
company duly registered under the laws of Israel of

P
O Box 95, Rehovot 7610002, Israel

(hereinafter,
“Yeda”)

 

and

 

CELL
SOURCE LIMITED

a
company duly registered under the laws of Israel of

5
Kineret Street, Bnei Brak 5126237

(hereinafter,
“Cell Source”)

 

	WHEREAS	Yeda
                                            and Cell Source are parties (the “Parties”) to a Research and Licence
                                            Agreement dated October 3, 2011, as amended by a First Amendment thereto dated April 8, 2014,
                                            a Second Amendment thereto dated November 28, 2016, a Third Amendment thereto dated March
                                            29, 2018, a Fourth Amendment thereto dated March 30, 2018, a Fifth Amendment thereto dated
                                            June 30, 2019, a Sixth Amendment thereto dated December 31, 2019 and a Seventh Amendment
                                            thereto dated November 15, 2020 (together, “the R&L Agreement”); and

 

	WHEREAS	Cell
                                            Source wishes revise the milestones associated with the agreement as set out in, and under
                                            the conditions of, this Amendment;

 

NOW
THEREFORE IT IS AGREED BY THE PARTIES HERETO AS FOLLOWS:

 

		1.	Terms
                                            and phrases used in this Amendment which are defined in the R&L Agreement shall have
                                            in this Amendment the same meaning as that attributed to them in the R&L Agreement, unless
                                            otherwise expressly defined in this Amendment.

 

		2.	This
                                            Amendment and the R&L Agreement shall be read as one and shall represent the complete
                                            current understanding between the Parties with respect to the subject matter hereof. Subject
                                            to the modifications contained herein, the provisions of the R&L Agreement shall remain
                                            unaltered and in full force and effect.

 

		3.	The
                                            above preamble and sections form an integral part of this Amendment.

 

		4.	The
                                            milestone in Clause 13.2.1(b) of the R&L Agreement, shall be replaced by the following:

 

(b)
by January 1, 2025, to commence Phase II clinical trials with respect to the First Product, provided that in the event that during a
consecutive period of 18 months prior to such date, no clinical trials in respect of the First Product are performed and no sponsored
research in respect of any Product under the R&L Agreement is substantively funded by the Company, then the milestone shall be deemed
not to have been achieved;

 

    	 

    	 

    

 

		5.	The
                                            milestone in Clause 13.2.1(c) of the R&L Agreement shall be replaced by the following:

 

(c)
by January 1, 2028, to have either commenced Phase Ill clinical trials or to have received FDA or EMA marketing approval in respect of
a product (“Marketing Approval”); however, if the Company can prove to Yeda’s satisfaction, at Yeda’s sole discretion,
that Phase Ill is not necessary for obtaining marketing approval, then this milestone need not be achieved;

 

		6.	It
                                            is agreed that delays in the achievement of the milestones in Clause 13.2 of the R&L
                                            Agreement, which do not exceed 24 months, and result from causes beyond such Company’s
                                            reasonable control and without any fault of Company, including fire, explosion, flood, war,
                                            pandemic, strike, or riot, provided that Company uses commercially reasonable efforts to
                                            avoid or remove such causes of non-performance and continues performance under this Agreement
                                            with reasonable dispatch whenever such causes are removed, shall not be deemed failure to
                                            achieve such milestones. If the Company is affected by such circumstances it shall promptly
                                            notify Yeda in writing when such circumstances cause a delay or failure in performance and
                                            when they cease to do so.

 

		7.	This
                                            Amendment constitutes the entire agreement between the Parties hereto in respect of the subject
                                            matter hereof, and supersedes all prior agreements or understandings between the Parties
                                            relating to the subject matter hereof and may be amended only by a written document signed
                                            by both Parties hereto.

 

IN
WITNESS WHEREOF the parties hereto have set their signatures as of the Effective Date.

 

	for
    YEDA RESEARCH AND DEVELOPMENT COMPANY LTD.	 	for
    CELL SOURCE LIMITED
	 	 	 
	Signature:	/s/
    Opher Shapira /s/ Irit Sagi	 	Signature:	/s/
    Itamar Shimrat
	Name	Dr.
    Opher Shapira and Prof. Irit Sagi	 	Name:	Itamar
    Shimrat
	Title	CEO
    Chair	 	Title:	Chief
    Exeecutive Officer

 

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