Exhibit 10.34
 
SECOND AMENDMENT TO RESEARCH AND LICENCE AGREEMENT
(this “Amendment”)

Effective Date: November 28, 2016

By and between

YEDA RESEARCH AND DEVELOPMENT COMPANY LIMITED
a company duly registered under the laws of Israel of P O Box 95, Rehovot 76100,
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 to a research and licence agreement dated
October 3rd, 2011, as amended by a first amendment thereto dated April 8, 2014
(together, "the R&L Agreement”); and

WHEREAS
Cell Source has notified Yeda in writing that it does not wish to exercise its
option rights under the Evaluation and Exclusive License Agreement between the
parties dated October 3rd, 2011 (as amended from time to time), and the parties
wish to amend the R&L Agreement accordingly; and

WHEREAS
the parties also wish to update Appendix A (Patent Cards) of the R&L Agreement,
to amend the development milestones and to make certain additional amendments to
the R&L Agreement, all subject to the terms and conditions set out in this
Amendment below.

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 forms an integral part of this Amendment.

 

--------------------------------------------------------------------------------

 
4.
The R&L Agreement shall be modified, as of the Effective Date, as follows:

4.1
In the first paragraph of the preamble thereto, the numbers “2000-017, 2005-082,
2008-108, 2010-071, 2010-073, 2011-077” shall be deleted and replaced by the
following: “2000-017, 2008-108, 2010-073, 2011-077, 2011-095, 2015-049,
2015-062, 2016-027” and Appendix A to the R&L Agreement shall be replaced in its
entirety by Annex A of this Amendment;

4.2
The final paragraph of the preamble thereto (including Appendix 1 thereto which
is referenced in said paragraph) shall be deleted in its entirety;

4.3
Clause 3 thereto shall be amended such that the words: “provided that, in the
event the a R&L Agreement shall be executed between the parties in accordance of
the E&O Agreement (as amended), then the annual Research Budget in respect of
the Research Period shall, beginning on the date such R&L Agreement shall be
signed, be an amount of US$ 900,000 (nine hundred thousand US Dollars) per year”
shall be deleted;

4.4
The final paragraph of clause 3 thereto shall be deleted in its entirety and
replaced by the following:

“In addition to the sums detailed in this clause 3 above, within 7 (seven) days
of the achievement of the Company of the receipt of an aggregate total equity
capital investment in the Company of more than $10,000,000 (ten million US
dollars), the Company shall pay Yeda a non-refundable payment in the sum of
US $200,000 (two hundred thousand US Dollars) (the “Additional Research
Payment”). The Additional Research Payment shall be allocated by Yeda to support
research activities of the Scientist under this Agreement according to an
additional Research plan to be submitted to the Company by Yeda.

4.5
In clause 4 thereto, the words “3 (three) month” shall be deleted wherever they
appear and replaced by the words “6 (six) month”;

4.6
Clause 13.2.1 shall be deleted in its entirety and replaced by the following:

“13.2.1
If the Company fails to achieve any one of the milestones set forth in
sub-clauses (a) to (e) below by the dates specified therefor, Yeda shall be
entitled, at its option: (i) to modify the Licence hereunder so that it is
non-exclusive only, by written notice to the Company (any such amendment of this
Agreement by Yeda as aforesaid, being effective immediately, the Company’s
consent thereto (written or otherwise) not being required, notwithstanding the
provisions of clause 17.2 below); or (ii) to terminate this Agreement (including
the Licence hereunder) by giving the Company 30 (thirty) days’ written notice:

(a) by January 1, 2018, to have successfully filed a pre-IND application in
respect of a Product with the FDA or other equivalent regulatory agency in
another country;

(b) by January 1, 2021, to have commenced Phase II clinical trials in a respect
of a Product;
 
2

--------------------------------------------------------------------------------

(c) by July 1, 2023, to have either commenced Phase III clinical trials or to
have received FDA or EMA marketing approval in a respect of a Product
(“Marketing Approval”);

(d) within 12 (twelve) months from the date of Marketing Approval, to have made
a First Commercial Sale of a Product; or

(e) in case commercial sale of any Product having commenced, there shall be a
period of 12 (twelve) months or more during which no sales of any Product shall
take place by the Company or its Sublicensees (except as a result of force
majeure or other factors beyond the control of the Company).";

4.7
In clause 13 thereto, the words “which has not been cured by the party in breach
within 21 (twenty-one) days (or, in the case of failure by the Company to pay
any amount due from the Company to Yeda pursuant to or in connection with this
Agreement on or before the due date of payment, 10 (ten) days)” shall deleted
and replaced by the words: “which has not been cured by the party in breach
within 30 (thirty) days”;

and

4.8
Yeda’s bank details in clause 17.7 thereto shall deleted and replaced by the
following: “Bank Leumi le–Israel B.M., Rehovot business branch, 2 Ilan Ramon
Street, Ness Ziona, branch #978, account no. 6370094; swift: LUMIILITTLV,
Routing Number: IL010978, IBAN no. IL7401 09780 0000 0637 0094”.

5.
For the avoidance of doubt, this Amendment constitutes the entire agreement
between the parties hereto in respect of the subject matter hereof, and
supersede all prior agreements or understandings between the parties relating to
the subject matter hereof (including any previous correspondence in this regard,
between the parties, or on their behalf) and may be amended only by a written
document signed by both parties hereto.

[signature page follows]

 
3

--------------------------------------------------------------------------------

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

For    YEDA RESEARCH AND DEVELOPMENT COMPANY LIMITED
 
For    CELL SOURCE LIMITED
         
Signature:
/s/ Mudl Sheves
/s/ Gil Granot-Mayor
 
Signature:
/s/ Itamar Shimrat
         
Name
Prof. Mudl Sheves
Gil-Granot-Mayor
 
Name:
Itamar Shimrat
Title
Chairman
CEO
 
Title:
Chief Executive Officer

4

--------------------------------------------------------------------------------

Annex A – Updated Patent Cards
 
PATENT CARD
 
2000-017
 
Title: VETO CELLS EFFECTIVE IN PREVENTING GRAFT REJECTION AND DEVOID OF GRAFT
VERSUS HOST POTENTIAL
 
Inventors: REISNER Yair, MARTELLI Massimo
 
Country
Application
Publication
Grant
Status
         
U.S.A
05/01/2000 - 09/477,737
-
6,544,506 - 08/04/2003
Granted
PCT
28/12/2000 - PCT/IL00/00872
12/07/2001 - WO 01/49243
-
Published
European Patent Office
28/12/2000 - 00983473.0
02/10/2002 - 1 244 803
1 244 803 - 22/02/2006
Validated
   France
28/12/2000 - 00983473.0
-
1 244 803 - 22/02/2006
Granted
   Germany
28/12/2000 - 00983473.0
-
60026166.2 - 22/02/2006
Granted
   Italy
28/12/2000 - 00983473.0
-
1 244 803 - 22/02/2006
Granted
   Switzerland
28/12/2000 - 00983473.0
-
1 244 803 - 22/02/2006
Granted
   United Kingdom
28/12/2000 - 00983473.0
-
1 244 803 - 22/02/2006
Granted
Israel
28/12/2000 - 150440
-
150440 - 31/03/2011
Granted
U.S.A
28/12/2000 - 10/169,028
-
7,270,810 - 18/09/2007
Granted

 
PATENT CARD
 
2008-108
 
Title: ANTI THIRD PARTY CENTRAL MEMORY T CELLS, METHODS OF PRODUCING SAME AND
USE OF SAME IN TRANSPLANTATION AND DISEASE TREATMENT
 
Inventors: REISNER Yair, OPHIR Eran, EIDELSTEIN Yaki, BACHAR-LUSTIG Esther

Country
Application
Publication
Grant
Status
         
U.S.A
30/10/2008 - 61/193,137
-
-
Expired
U.S.A
12/06/2009 - 61/213,482
-
-
Expired
PCT
29/10/2009 - PCT/IL2009/001014
06/05/2010 - WO 2010/049935
-
Published
China
29/10/2009 - 200980153053.4
07/12/2011 - 102271702
ZL200980153053.4 - 25/11/2015
Granted
European Patent Office
29/10/2009 - 09764302.7
21/09/2011 - 2 365 823
-
Pending
India
29/10/2009 - 905/MUMNP/2011
-
-
Pending
Israel
29/10/2009 - 212587
-
212587 - 01/04/2016
Granted
Russian Federation
29/10/2009 - 2011121630
-
2506311 - 10/02/2014
Granted
U.S.A
29/10/2009 - 13/126,472
01/09/2011 - 2011-0212071
-
Pending

 
5

--------------------------------------------------------------------------------

 
PATENT CARD
 
2010-073
 
Title: USE OF ANTI THIRD PARTY CENTRAL MEMORY T CELLS FOR ANTI-LEUKEMIA/LYMPHOMA
TREATMENT
 
Inventors: REISNER Yair, LASK Assaf, OPHIR Eran, OR-GEVA Noga, COHEN Adva

Country
Application
Publication
Grant
Status
         
U.S.A
08/09/2010 - 61/380,716
-
-
Expired
PCT
08/09/2011 - PCT/IL2011/000727
15/03/2012 - WO 2012/032526
-
Published
Brazil
08/09/2011 - BR 11 2013 005756 4
31/12/2013 - BR 11 2013 005756 4
-
Published
Canada
08/09/2011 - 2,810,632
-
-
Pending
China
08/09/2011 - 201610307275.9
31/08/2016 - CN 105907713 A
-
Published
China
08/09/2011 - 201180053858.9
04/09/2013 - CN 103282047 A
ZL201180053858.9 - 24/08/2016
Granted
European Patent Office
08/09/2011 - 11773325.3
17/07/2013 - 2 613 801
2 613 801 - 08/06/2016
Validated
   Austria
08/09/2011 - 11773325.3
17/07/2013 - 2 613 801
2 613 801 - 08/06/2016
Granted
   Belgium
08/09/2011 - 11773325.3
17/07/2013 - 2 613 801
2 613 801 - 08/06/2016
Granted
   Czech Republic
08/09/2011 - 11773325.3
17/07/2013 - 2 613 801
2 613 801 - 08/06/2016
Granted
   France
08/09/2011 - 11773325.3
17/07/2013 - 2 613 801
2 613 801 - 08/06/2016
Granted
   Germany
08/09/2011 - 11773325.3
17/07/2013 - 2 613 801
2 613 801 - 08/06/2016
Granted
   Greece
08/09/2011 - 11773325.3
17/07/2013 - 2 613 801
2 613 801 - 08/06/2016
Granted
   Hungary
08/09/2011 - 11773325.3
17/07/2013 - 2 613 801
2 613 801 - 08/06/2016
Granted
   Ireland
08/09/2011 - 11773325.3
17/07/2013 - 2 613 801
2 613 801 - 08/06/2016
Granted
   Italy
08/09/2011 - 11773325.3
17/07/2013 - 2 613 801
2 613 801 - 08/06/2016
Granted
   Poland
08/09/2011 - 11773325.3
17/07/2013 - 2 613 801
2 613 801 - 08/06/2016
Granted
   Portugal
08/09/2011 - 11773325.3
17/07/2013 - 2 613 801
2 613 801 - 08/06/2016
Granted
   Spain
08/09/2011 - 11773325.3
17/07/2013 - 2 613 801
2 613 801 - 08/06/2016
Granted
   Sweden
08/09/2011 - 11773325.3
17/07/2013 - 2 613 801
2 613 801 - 08/06/2016
Granted
   Switzerland
08/09/2011 - 11773325.3
17/07/2013 - 2 613 801
2 613 801 - 08/06/2016
Granted
   The Netherlands
08/09/2011 - 11773325.3
17/07/2013 - 2 613 801
2 613 801 - 08/06/2016
Granted
   Turkey
08/09/2011 - 11773325.3
17/07/2013 - 2 613 801
2 613 801 - 08/06/2016
Granted
   United Kingdom
08/09/2011 - 11773325.3
17/07/2013 - 2 613 801
2 613 801 - 08/06/2016
Granted

 
6

--------------------------------------------------------------------------------

 
 
Hong Kong
08/09/2011 - 14100513.2
-
-
Allowed
Israel
08/09/2011 - 225102
-
-
Pending
Japan
08/09/2011 - 2013-527738
30/09/2013 - P2013-537187A
5,977,238 - 29/07/2016
Granted
Korea
08/09/2011 - 2013-7008892
-
-
Pending
Mexico
08/09/2011 - MX/a/2013/002668
-
-
Pending
Singapore
08/09/2011 - 201301743-9
-
188473 - 26/01/2016
Granted
U.S.A
08/09/2011- 15/242,666
-
-
Pending
U.S.A
08/09/2011 - 13/821,255
04/07/2013 - 2013-0171108-A1
9,421,228 - 23/08/2016
Granted

PATENT CARD
 
2011-077
 
Title: ANTI THIRD PARTY CENTRAL MEMORY T CELLS, METHODS OF PRODUCING SAME AND
USE OF SAME IN TRANSPLANTATION AND DISEASE TREATMENT
 
Inventors: REISNER Yair, EIDELSTEIN Yaki, OPHIR Eran, LASK Assaf, AFIK Ran,
BACHAR-LUSTIG Esther, OR-GEVA Noga

Country
Application
Publication
Grant
Status
         
U.S.A
08/09/2011 - 61/532,172
-
-
Expired
PCT
06/09/2012 - PCT/IL2012/050354
14/03/2013 - WO 2013/035099
-
Published
Australia
06/09/2012 - 20120305931
-
-
Pending
Brazil
06/09/2012 - BR 11 2014 005355 3
21/10/2014 -
-
Published
Canada
06/09/2012 - 2,848,121
-
-
Pending
China
06/09/2012 - 201280054739.X
16/07/2014 - CN 103930130 A
201280054739.X - 06/06/2016
Granted
European Patent Office
06/09/2012 - 12769743.1
16/07/2014 - 2753351
-
Pending
Hong Kong
06/09/2012 - HK 15100534.6
31/07/2015 - 1200099A
-
Published
India
06/09/2012 - 577/MUMNP/2014
-
-
Pending
Israel
06/09/2012 - 231397
-
-
Pending
Japan
06/09/2012 - 2014-529143
06/10/2014 - P2014-526244A
-
Published
Korea
06/09/2012 - 10-2014-7009267
23/07/2014 - 10-2014-0092298
-
Published
Mexico
06/09/2012 - MX/a/2014/002771
-
-
Pending
New Zealand
06/09/2012 - 622749
-
622749 - 02/02/2016
Granted
Russian Federation
06/09/2012 - 2014110897
-
-
Pending
Singapore
06/09/2012 - 11201400513P
-
-
Pending
South Africa
06/09/2012 - 2014/01993
19/09/2014 -
-
Allowed
U.S.A
06/09/2012 - 14/343,053
31/07/2014 - 2014-0212398
-
Pending

 
7

--------------------------------------------------------------------------------

PATENT CARD
 
2011-095
 
Title: A COMBINATION THERAPY FOR A STABLE AND LONG TERM ENGRAFTMENT USING
SPECIFIC PROTOCOLS FOR T/B CELL DEPLETION
 
Inventors: REISNER Yair, BACHAR-LUSTIG Esther

Country
Application
Publication
Grant
Status
         
U.S.A
22/12/2011 - 61/578,917
-
-
Expired
PCT
20/12/2012 - PCT/IL2012/050542
27/06/2013 - WO 2013/093920
-
Published
PCT
20/12/2012 - PCT/IL2012/050541
27/06/2013 - WO 2013/093919
-
Published
Australia
20/12/2012 - 2012355990
-
-
Pending
Australia
20/12/2012 - 2012355989
-
-
Pending
Brazil
20/12/2012 - BR 11 2014 015960 2
21/10/2014 -
-
Pending
Brazil
20/12/2012 - BR 11 2014 015959 9
-
-
Pending
Canada
20/12/2012 - 2,859,953
27/06/2013 -
-
Pending
Canada
20/12/2012 - 2,859,952
27/06/2013 -
-
Pending
China
20/12/2012 - 201280068202.9
25/03/2015 - CN 104470542 A
-
Pending
China
20/12/2012 - 201280068917.4
08/10/2014 - CN 104093314 A
-
Pending
European Patent Office
20/12/2012 - 12859036.1
29/10/2014 - 2793914
-
Pending
European Patent Office
20/12/2012 - 12861023.5
05/11/2014 - 2797421
-
Pending
Hong Kong
20/12/2012 - 15103467.1
09/10/2015 - 1202810A
-
Published
Hong Kong
20/12/2012 - 15103468.0
09/10/2015 - 1202775A
-
Published
India
20/12/2012 - 1468/MUMNP/2014
27/06/2013 -
-
Pending
India
20/12/2012 - 1467/MUMNP/2014
27/06/2013 -
-
Pending
Israel
20/12/2012 - 233303
27/06/2013 - WO 2013/093920
-
Pending
Israel
20/12/2012 - 233302
27/06/2013 - WO 2013/093919
-
Pending
Japan
20/12/2012 - 2014-548337
05/02/2015 - P2015-504047A
-
Pending
Japan
20/12/2012 - 2014-548336
22/01/2015 - 2015-502401
-
Pending
Korea
20/12/2012 - 10-2014-702449
04/09/2014 - 10-2014-0107564
2014/05071 - 25/11/2015
Granted
Korea
20/12/2012 - 10-2014-7020448
02/09/2014 - 10-2014-0105848
-
Published
Mexico
20/12/2012 - Mx/a/2014/007647
-
-
Pending
Mexico
20/12/2012 - Mx/a/2014/007648
27/06/2013 - WO 2013/093919
-
Pending
New Zealand
20/12/2012 - 627272
-
-
Pending
New Zealand
20/12/2012 - 627549
-
-
Pending

 
8

--------------------------------------------------------------------------------

 
 
Russian Federation
20/12/2012 - 2014128479
-
-
Pending
Russian Federation
20/12/2012 - 2014129632
27/06/2013 - WO 2013/093919
-
Pending
Singapore
20/12/2012 - 11201403459X
-
-
Pending
Singapore
20/12/2012 - 11201403456U
-
11201403456U - 08/06/2016
Granted
South Africa
20/12/2012 - 2014/05071
-
2014/05071 - 25/11/2015
Granted
South Africa
20/12/2012 - 2014/05298
-
2014/05298 - 25/11/2015
Granted
U.S.A
20/12/2012 - 14/367,923
18/12/2014 - 2014-0369974
-
Published
U.S.A
20/12/2012 - 14/367,917
11/12/2014 - 2014-0363437
-
Published

PATENT CARD
 
2015-049
 
Title: USE OF ANTI THIRD PARTY CENTRAL MEMORY T CELLS
 
Inventors: OR-GEVA Noga, OPHIR Eran, REISNER Yair, EIDELSTEIN Yaki, GIDRON Rotem

Country
Application
Publication
Grant
Status
         
U.S.A
16/07/2015 - 62/193,207
-
-
Expired
PCT
14/07/2016 - PCT/IL2016/050774
-
-
Pending

PATENT CARD
 
2015-062
 
Title: GENETICALLY MODIFIED ANTI-THIRD PARTY CENTRAL MEMORY T CELLS AND USE OF
SAME IN IMMUNOTHERAPY
 
Inventors: OR-GEVA Noga, OPHIR Eran, REISNER Yair, EIDELSTEIN Yaki, GIDRON Rotem

Country
Application
Publication
Grant
Status
         
U.S.A
16/07/2015 - 62/193,207
-
-
Expired
PCT
14/07/2016 -
-
-
Pending

PATENT CARD
 
2016-027
 
Title: VETO CELLS GENERATED FROM MEMORY T CELLS
 
Inventors: REISNER Yair, OR-GEVA Noga, GIDRON Rotem, BACHAR-LUSTIG Esther, LASK
Assaf, KAGAN Sivan

Country
Application
Publication
Grant
Status
         
U.S.A
27/06/2016 -
-
-
Pending

9