SECOND AMENDMENT TO RESEARCH AND LICENCE AGREEMENT (this “Amendment”)
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 X X Xxx 00, Xxxxxxx 00000, Xxxxxx
(hereinafter, “Yeda”)
and
CELL SOURCE LIMITED
a company duly registered under the laws of Israel of 0 Xxxxxxx Xxxxxx, Xxxx Xxxx 0000000
(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 Xxxx Xxxxx Street, Xxxx Xxxxx, branch #978, account no. 0000000; swift: XXXXXXXXXXX, Routing Number: IL010978, IBAN no. XX0000 00000 0000 0000 0000”.
|
|
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/ Xxx Xxxxxx-Mayor
|
Signature:
|
/s/ Xxxxxx Xxxxxxx
|
|
|
Name
|
Prof. Mudl Sheves
Xxx-Xxxxxx-Mayor
|
Name:
|
Xxxxxx Xxxxxxx
|
|
|
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: XXXXXXX Xxxx, XXXXXXXX Xxxxxxx
|
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: XXXXXXX Xxxx, XXXXX Xxxx, XXXXXXXXXX Yaki, XXXXXX-XXXXXX Xxxxxx
|
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: XXXXXXX Xxxx, XXXX Xxxxx, XXXXX Xxxx, OR-XXXX Xxxx, XXXXX Xxxx
|
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
|
00/00/0000 - 000000
|
-
|
-
|
Xxxxxxx
|
|
Xxxxx
|
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: XXXXXXX Xxxx, XXXXXXXXXX Yaki, XXXXX Xxxx, XXXX Xxxxx, AFIK Ran, XXXXXX-XXXXXX Xxxxxx, OR-XXXX Xxxx
|
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
|
00/00/0000 - 0000000
|
-
|
Xxxxxxx
|
|
Xxxx Xxxx
|
06/09/2012 - HK 15100534.6
|
00/00/0000 - 0000000X
|
-
|
Xxxxxxxxx
|
|
Xxxxx
|
06/09/2012 - 577/MUMNP/2014
|
-
|
-
|
Pending
|
|
Israel
|
00/00/0000 - 000000
|
-
|
-
|
Xxxxxxx
|
|
Xxxxx
|
06/09/2012 - 2014-529143
|
06/10/2014 - P2014-526244A
|
-
|
Published
|
|
Korea
|
06/09/2012 - 00-0000-0000000
|
00/00/0000 - 00-0000-0000000
|
-
|
Xxxxxxxxx
|
|
Xxxxxx
|
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: XXXXXXX Xxxx, XXXXXX-XXXXXX Xxxxxx
|
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
|
00/00/0000 - 0000000000
|
-
|
-
|
Xxxxxxx
|
|
Xxxxxxxxx
|
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
|
00/00/0000 - 0000000
|
-
|
Xxxxxxx
|
|
Xxxx Xxxx
|
20/12/2012 - 15103467.1
|
00/00/0000 - 0000000X
|
-
|
Xxxxxxxxx
|
|
Xxxx Xxxx
|
20/12/2012 - 15103468.0
|
00/00/0000 - 0000000X
|
-
|
Xxxxxxxxx
|
|
Xxxxx
|
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 - 00-0000-000000
|
04/09/2014 - 00-0000-0000000
|
2014/05071 - 25/11/2015
|
Granted
|
|
Korea
|
20/12/2012 - 00-0000-0000000
|
02/09/2014 - 00-0000-0000000
|
-
|
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-XXXX Xxxx, XXXXX Xxxx, XXXXXXX Xxxx, XXXXXXXXXX Yaki, XXXXXX Xxxxx
|
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-XXXX Xxxx, XXXXX Xxxx, XXXXXXX Xxxx, XXXXXXXXXX Yaki, XXXXXX Xxxxx
|
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: XXXXXXX Xxxx, OR-XXXX Xxxx, XXXXXX Xxxxx, XXXXXX-XXXXXX Xxxxxx, XXXX Xxxxx, XXXXX Xxxxx
|
Country
|
Application
|
Publication
|
Grant
|
Status
|
|
U.S.A
|
27/06/2016 -
|
-
|
-
|
Pending
|
9
