form10ka.htm


SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 10-K/A-2

x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended December 31, 2010

OR

o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from___________ to __________

Commission file number 1-12830

BioTime, Inc.
(Exact name of registrant as specified in its charter)

California
94-3127919
(State or other jurisdiction of incorporation or organization)
(I.R.S. Employer Identification No.)

1301 Harbor Bay Parkway, Suite 100
Alameda, California 94502
(Address of principal executive offices) (Zip Code)

Registrant’s telephone number, including area code (510) 521-3390

Securities registered pursuant to Section 12(b) of the Act
Title of class Common Shares, no par value

Securities registered pursuant to Section 12(g) of the Act:
None

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes o No x
 
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes o No x
 
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No o

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§229.405 of this chapter) is not contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. x
 
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.
 
Large accelerated filer o
Accelerated filer x
Non-accelerated filer o (Do not check if a smaller reporting company)
Smaller reporting company o

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act): Yes o No x
 
The approximate aggregate market value of voting common shares held by non-affiliates computed by reference to the price at which common shares were last sold as of June 30, 2010 was $123,743,749. Shares held by each executive officer and director and by each person who beneficially owns more than 5% of the outstanding common shares have been excluded in that such persons may under certain circumstances be deemed to be affiliates. This determination of affiliate status is not necessarily a conclusive determination for other purposes.

The number of common shares outstanding as of March 1, 2011 was 48,357,360

Documents Incorporated by Reference
Portions of Proxy Statement for 2011 Annual Meeting of Shareholders are incorporated by reference in Part III
 


 
1

 
 
PART IV

Item 15. Exhibits, Financial Statement Schedules

(a-1) Financial Statements.

The following financial statements of BioTime, Inc. are filed in the Form 10-K:

Consolidated balance sheets
Consolidated statements of operations
Consolidated statements of shareholders' deficit
Consolidated statements of cash flows

Notes to Financial Statements

(a-2) Financial Statement Schedules

All schedules are omitted because the required information is inapplicable or the information is presented in the financial statements or the notes thereto.
 
(a-3) Exhibits.
 
 
2

 
 
Exhibit
Numbers
 
Description
 
 
 
2.1
 
Equity and Note Purchase Agreement entered into as of April 28, 2010 by and between ES Cell Australia Limited, Pharmbio Growth Fund Pte Ltd., and Biomedical Sciences Investment Fund Pte., Ltd. 19
 
 
 
2.2
 
Transfer Agreement dated May 3, 2010 between BioTime, Inc. and certain shareholders of ES Cell International Pte. Ltd. 19
 
 
 
2.3
 
Agreement and Plan of Merger dated February 11, 2010, between Glycosan BioSystems, Inc., OrthoCyte Corporation, and BioTime, Inc. *
 
 
 
3.1
 
Articles of Incorporation with all amendments. 18
 
 
 
3.2
 
By-Laws, As Amended. 2
 
 
 
4.1
 
Specimen of Common Share Certificate. 1
 
 
 
4.2
 
Warrant Agreement between BioTime, Inc., Broadwood Partners, L.P., and George Karfunkel. 16
 
 
 
4.3
 
Form of Warrant. 16
 
 
 
4.4
 
Warrant Agreement between BioTime, Inc. and Biomedical Sciences Investment Fund Pte Ltd. 19
 
 
3

 
 
10.1
 
Intellectual Property Agreement between BioTime, Inc. and Hal Sternberg. 1
 
 
 
10.2
 
Intellectual Property Agreement between BioTime, Inc. and Judith Segall. 1
 
 
 
10.3
 
2002 Stock Option Plan, as amended. 18
 
 
 
10.4
 
Exclusive License Agreement between Abbott Laboratories and BioTime, Inc. (Portions of this exhibit have been omitted pursuant to a request for confidential treatment). 3
 
 
 
10.5
 
Modification of Exclusive License Agreement between Abbott Laboratories and BioTime, Inc. (Portions of this exhibit have been omitted pursuant to a request for confidential treatment). 4
 
 
 
10.6
 
Exclusive License Agreement between BioTime, Inc. and CJ Corp. 5
 
 
 
10.7
 
Hextend and PentaLyte Collaboration Agreement between BioTime, Inc. and Summit Pharmaceuticals International Corporation.6
 
 
 
10.8
 
Addendum to Hextend and PentaLyte Collaboration Agreement between BioTime Inc. and Summit Pharmaceuticals International Corporation. 7
 
 
 
10.9
 
Amendment to Exclusive License Agreement between BioTime, Inc. and Hospira, Inc. 8
 
 
 
10.10
 
Hextend and PentaLyte China License Agreement between BioTime, Inc. and Summit Pharmaceuticals International Corporation. 9
 
 
 
10.11
 
Employment Agreement, dated October 10, 2007, between BioTime, Inc. and Michael D. West. 11
 
 
 
10.12
 
Commercial License and Option Agreement between BioTime and Wisconsin Alumni Research Foundation. 10
 
 
 
10.13
 
License, Product Production, and Distribution Agreement, dated June 19, 2008, among Lifeline Cell Technology, LLC, BioTime, Inc., and Embryome Sciences, Inc. 12
 
 
 
10.14
 
License Agreement, dated July 10, 2008, between Embryome Sciences, Inc. and Advanced Cell Technology, Inc. 12
 
 
 
10.15
 
License Agreement, dated August 15, 2008 between Embryome Sciences, Inc. and Advanced Cell Technology, Inc. 13
 
 
 
10.16
 
Sublicense Agreement, dated August 15, 2008 between Embryome Sciences, Inc. and Advanced Cell Technology, Inc. 13

 
4

 
 
10.17
 
Stem Cell Agreement, dated February 23, 2009, between Embryome Sciences, Inc. and Reproductive Genetics Institute. 14
 
 
 
10.18
 
First Amendment of Commercial License and Option Agreement, dated March 11, 2009, between BioTime and Wisconsin Alumni Research Foundation. 14
 
 
 
10.19
 
Employment Agreement, dated October 10, 2007, between BioTime, Inc. and Robert Peabody. 14
 
 
 
10.20
 
Fifth Amendment of Revolving Line of Credit Agreement, dated April 15, 2009. 15
 
 
 
10.21
 
Form of Amendment of Revolving Credit Note. 15
 
 
 
10.22
 
Fifth Amendment of Security Agreement, dated April 15, 2009. 15
 
 
 
10.23
 
Stock and Warrant Purchase Agreement between BioTime, Inc. and George Karfunkel. 16
 
 
 
10.24
 
Stock and Warrant Purchase Agreement between BioTime, Inc. and Broadwood Partners, L.P. 16
 
 
 
10.25
 
Registration Rights Agreement between BioTime, Inc., Broadwood Partners, L.P. and George Karfunkel.16
 
 
 
10.26
 
Co-Exclusive OEM Supply Agreement, date July 7, 2009, between Embryome Sciences, Inc. and Millipore Corporation (Portions of this exhibit have been omitted pursuant to a request for confidential treatment). 17
 
 
 
10.27
 
Stock Purchase Agreement between OncoCyte Corporation and George Karfunkel. 18
 
 
 
10.28
 
Registration Rights Agreement between OncoCyte Corporation and George Karfunkel. 18
 
 
 
10.29
 
Employment Agreement, dated August 3, 2009, between BioTime, Inc. and Walter Funk. 19
 
 
 
10.30
 
Sublease Agreement for 20 Biopolis #05-05/06 Centros, Singapore between Bioprocessing Technology Institute, Biomedical Sciences Institutes and ES Cell International Pte. Ltd. 20
 
 
 
10.31
 
Share Purchase Agreement, dated October 7, 2010, by and among Cell Cure Neurosciences, Limited, Teva Pharmaceutical Industries, Ltd, HBL-Hadasit Bio-Holdings, Ltd., and BioTime, Inc. 21
 
 
 
10.32
 
Amended and Restated Shareholders Agreement, dated October 7, 2010, by and among ES Cell International Pte. Ltd, BioTime, Inc., Teva Pharmaceutical Industries, Limited, HBL-Hadasit Bio-Holdings, Ltd., and Cell Cure Neurosciences Ltd. *
 
 
 
 
Research and Exclusive License Option Agreement, dated October 7, 2010, between Teva Pharmaceutical Industries, Ltd. and Cell Cure Neurosciences Ltd. (Portions of this exhibit have been omitted pursuant to a request for confidential treatment).**
 
 
 
10.34
 
Amended and Restated Research and License Agreement, dated October 7, 2010, between Hadasit Medical Research Services and Development Ltd. and Cell Cure Neurosciences Ltd. *
 
 
 
10.35
 
Additional Research Agreement, dated October 7, 2010, between Hadasit Medical Research Services and Development Ltd. and Cell Cure Neurosciences Ltd. *

 
5

 
 
10.36
 
Exclusive License Agreement, dated November 20, 2007, between Cell Targeting, Inc. and Burnham Institute for Medical Research. *
 
 
 
10.37
 
Stock Purchase Agreement, dated December 29, 2010, between Embryome Sciences, Inc. and Life Extension Foundation. *
 
 
 
10.38
 
Stock Purchase Agreement, dated December 30, 2010, between Embryome Sciences, Inc. and Geothermal Coring, S.A. *
 
 
 
10.39
 
Co-Exclusive Supply Agreement, Dated December 8, 2010, between BioTime Asia Limited and Shanghai Genext Medical Technology Co. Ltd *
 
 
 
10.40
 
OncoCyte Corporation 2010 Stock Option Plan Form of OncoCyte Corporation Stock Option Agreement *
 
 
 
10.41
 
OrthoCyte Corporation 2010 Stock Option Plan Form of OrthoCyte Corporation Stock Option Agreement *
 
 
 
10.42
 
BioTime Asia, Limited 2010 Stock Option Plan Form of BioTime Asia, Limited Stock Option Agreement *
 
 
 
10.43
 
ReCyte Therapeutics, Inc. 2010 Stock Option Plan Form of ReCyte Therapeutics, Inc. Stock Option Agreement *
 
 
 
10.44
 
Lease, dated October 28, 2010, between SKS Harbor Bay Associates, LLC and BioTime, Inc. *
 
 
 
10.45
 
Memorandum of Tenancy, Renewal of Tenancy and letters of offer and acceptance of renewal of tenancy between ES Cell International Pte. Ltd. and Jurong Town Corporation *
 
 
 
10.46
 
Genome Office Tenancy Renewal, Renewal of Tenancy and letters of offer and acceptance of renewal of tenancy between ES Cell International Pte Ltd. and Jurong Town Corporation *
 
 
 
21.1
 
List of Subsidiaries *
 
 
 
 
Rule 13a-14(a)/15d-14(a) Certification. **
 
 
 
 
Section 1350 Certification.**
 
 
6

 
 
1
Incorporated by reference to Registration Statement on Form S-1, File Number 33-44549 filed with the Securities and Exchange Commission on December 18, 1991, and Amendment No. 1 and Amendment No. 2 thereto filed with the Securities and Exchange Commission on February 6, 1992 and March 7, 1992, respectively.

2
Incorporated by reference to Registration Statement on Form S-1, File Number 33-48717 and Post-Effective Amendment No. 1 thereto filed with the Securities and Exchange Commission on June 22, 1992, and August 27, 1992, respectively.

3
Incorporated by reference to BioTime’s Form 8-K, filed April 24, 1997.

4
Incorporated by reference to BioTime’s Form 10-Q for the quarter ended June 30, 1999.

5
Incorporated by reference to BioTime’s Form 10-K/A-1 for the year ended December 31, 2002.

6
Incorporated by reference to BioTime’s Form 8-K, filed December 30, 2004.

7
Incorporated by reference to BioTime’s Form 8-K, filed December 20, 2005.

8
Incorporated by reference to BioTime’s Form 8-K, filed January 13, 2006.

9
Incorporated by reference to BioTime’s Form 8-K, filed March 30, 2006.

10
Incorporated by reference to BioTime’s Form 8-K, filed January 9, 2008.

11
Incorporated by reference to BioTime’s Form 10-KSB for the year ended December 31, 2007.

12
Incorporated by reference to BioTime’s Form 10-Q for the quarter ended June 30, 2008.

13
Incorporated by reference to BioTime’s Form 10-Q for the quarter ended September 30, 2008.

14
Incorporated by reference to BioTime’s Form 10-K for the year ended December 31, 2008.

15
Incorporated by reference to BioTime’s Form 8-K filed April 17, 2009.

16
Incorporated by reference to BioTime’s Form 10-Q for the quarter ended March 31, 2009.

17
Incorporated by reference to BioTime’s Form 10-Q for the quarter ended June 30, 2009.

18
Incorporated by reference to BioTime’s Form 10-Q for the quarter ended September 30, 2009.

19
Incorporated by reference to BioTime’s Form 10-Q for the quarter ended March 31, 2010.

20
Incorporated by reference to BioTime’s Form 10-Q for the quarter ended June 30, 2010.

21
Incorporated by reference to BioTime’s Form 8-K filed October 19, 2010.

Previously filed.
 
**
Filed herewith.
 
 
7

 
 
SIGNATURES

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report on Form 10-K to be signed on its behalf by the undersigned, thereunto duly authorized on the 30 day of June, 2011.

 
BIOTIME, INC.
 
 
 
By:
/s/Michael D. West
 
 
Michael D. West, Ph.D.
 
 
Chief Executive Officer

 
8

 
 
Exhibit
Numbers
 
Description
 
 
 
2.1
 
Equity and Note Purchase Agreement entered into as of April 28, 2010 by and between ES Cell Australia Limited, Pharmbio Growth Fund Pte Ltd., and Biomedical Sciences Investment Fund Pte Ltd. 19
 
 
 
2.2
 
Transfer Agreement dated May 3, 2010 between BioTime, Inc. and certain shareholders of ES Cell International Pte. Ltd. 19
 
 
 
2.3
 
Agreement and Plan of Merger, dated February 11, 2010, between Glycosan BioSystems, Inc., OrthoCyte Corporation, and BioTime, Inc. *
 
 
 
3.1
 
Articles of Incorporation with all amendments. 18
 
 
 
3.2
 
By-Laws, As Amended. 2
 
 
 
4.1
 
Specimen of Common Share Certificate. 1
 
 
 
4.2
 
Warrant Agreement between BioTime, Inc., Broadwood Partners, L.P., and George Karfunkel. 16
 
 
 
4.3
 
Form of Warrant. 16

4.4
 
Warrant Agreement between BioTime, Inc. and Biomedical Sciences Investment Fund Pte Ltd. 19
 
 
 
10.1
 
Intellectual Property Agreement between BioTime, Inc. and Hal Sternberg. 1
 
 
 
10.2
 
Intellectual Property Agreement between BioTime, Inc. and Judith Segall. 1
 
 
 
10.3
 
2002 Stock Option Plan, as amended. 18
 
 
 
10.4
 
Exclusive License Agreement between Abbott Laboratories and BioTime, Inc. (Portions of this exhibit have been omitted pursuant to a request for confidential treatment). 3
 
 
 
10.5
 
Modification of Exclusive License Agreement between Abbott Laboratories and BioTime, Inc. (Portions of this exhibit have been omitted pursuant to a request for confidential treatment). 4
 
 
 
10.6
 
Exclusive License Agreement between BioTime, Inc. and CJ Corp. 5
 
 
 
10.7
 
Hextend and PentaLyte Collaboration Agreement between BioTime, Inc. and Summit Pharmaceuticals International Corporation.6
 
 
 
10.8
 
Addendum to Hextend and PentaLyte Collaboration Agreement Between BioTime Inc. and Summit Pharmaceuticals International Corporation. 7
 
 
 
10.9
 
Amendment to Exclusive License Agreement Between BioTime, Inc. and Hospira, Inc. 8
 
 
9

 

10.10
 
Hextend and PentaLyte China License Agreement Between BioTime, Inc. and Summit Pharmaceuticals International Corporation. 9
 
 
 
10.11
 
Employment Agreement, dated October 10, 2007, between BioTime, Inc. and Michael D. West. 11
 
 
 
10.12
 
Commercial License and Option Agreement between BioTime and Wisconsin Alumni Research Foundation. 10
 
 
 
10.13
 
License, Product Production, and Distribution Agreement, dated June 19, 2008, among Lifeline Cell Technology, LLC, BioTime, Inc., and Embryome Sciences, Inc. 12
 
 
 
10.14
 
License Agreement, dated July 10, 2008, between Embryome Sciences, Inc. and Advanced Cell Technology, Inc. 12
 
 
 
10.15
 
License Agreement, dated August 15, 2008 between Embryome Sciences, Inc. and Advanced Cell Technology, Inc. 13
 
 
 
10.16
 
Sublicense Agreement, dated August 15, 2008 between Embryome Sciences, Inc. and Advanced Cell Technology, Inc. 13
 
10.17
 
Stem Cell Agreement, dated February 23, 2009, between Embryome Sciences, Inc. and Reproductive Genetics Institute. 14
 
 
 
10.18
 
First Amendment of Commercial License and Option Agreement, dated March 11, 2009, between BioTime and Wisconsin Alumni Research Foundation. 14
 
 
 
10.19
 
Employment Agreement, dated October 10, 2007, between BioTime, Inc. and Robert Peabody. 14
 
 
 
10.20
 
Fifth Amendment of Revolving Line of Credit Agreement, dated April 15, 2009. 15
 
 
 
10.21
 
Form of Amendment of Revolving Credit Note. 15
 
 
 
10.22
 
Fifth Amendment of Security Agreement, dated April 15, 2009. 15
 
 
 
10.23
 
Stock and Warrant Purchase Agreement between BioTime, Inc. and George Karfunkel. 16
 
 
 
10.24
 
Stock and Warrant Purchase Agreement between BioTime, Inc. and Broadwood Partners, L.P. 16
 
 
 
10.25
 
Registration Rights Agreement between BioTime, Inc., Broadwood Partners, L.P. and George Karfunkel.16
 
 
 
10.26
 
Co-Exclusive OEM Supply Agreement, date July 7, 2009, between Embryome Sciences, Inc. and Millipore Corporation (Portions of this exhibit have been omitted pursuant to a request for confidential treatment). 17
 
 
10

 

10.27
 
Stock Purchase Agreement between OncoCyte Corporation and George Karfunkel. 18
 
 
 
10.28
 
Registration Rights Agreement between OncoCyte Corporation and George Karfunkel. 18
 
 
 
10.29
 
Employment Agreement, dated August 3, 2009, between BioTime, Inc. and Walter Funk. 19
 
 
 
10.30
 
Sublease Agreement for 20 Biopolis #05-05/06 Centros, Singapore between Bioprocessing Technology Institute, Biomedical Sciences Institutes and ES Cell International Pte. Ltd. 20
 
 
 
10.31
 
Share Purchase Agreement, dated October 7, 2010, by and among Cell Cure Neurosciences, Limited, Teva Pharmaceutical Industries, Ltd, HBL-Hadasit Bio-Holdings, Ltd., and BioTime, Inc. 21
 
 
 
10.32
 
Amended and Restated Shareholders Agreement, dated October 7, 2010, by and among ES Cell International Pte. Ltd, BioTime, Inc., Teva Pharmaceutical Industries, Limited, HBL-Hadasit Bio-Holdings, Ltd., and Cell Cure Neurosciences Ltd. *
 
 
 
 
Research and Exclusive License Option Agreement, dated October 7, 2010, between Teva Pharmaceutical Industries, Ltd. and Cell Cure Neurosciences Ltd. (Portions of this exhibit have been omitted pursuant to a request for confidential treatment).**
 
 
 
10.34
 
Amended and Restated Research and License Agreement, dated October 7, 2010, between Hadasit Medical Research Services and Development Ltd. and Cell Cure Neurosciences Ltd. *
 
 
 
10.35
 
Additional Research Agreement, dated October 7, 2010, between Hadasit Medical Research Services and Development Ltd. and Cell Cure Neurosciences Ltd. *
 
10.36
 
Exclusive License Agreement, dated November 20, 2007, between Cell Targeting, Inc. and Burnham Institute for Medical Research. *
 
 
 
10.37
 
Stock Purchase Agreement, dated December 29, 2010, between Embryome Sciences, Inc. and Life Extension Foundation. *
 
 
 
10.38
 
Stock Purchase Agreement, dated December 30, 2010, between Embryome Sciences, Inc. and Geothermal Coring, S.A. *
 
 
 
10.39
 
Co-Exclusive Supply Agreement, dated December 8, 2010, between BioTime Asia Limited and Shanghai Genext Medical Technology Co. Ltd *
 
 
 
10.40
 
OncoCyte Corporation 2010 Stock Option Plan Form of OncoCyte Corporation Stock Option Agreement *
 
 
 
10.41
 
OrthoCyte Corporation 2010 Stock Option Plan Form of OrthoCyte Corporation Stock Option Agreement *
 
 
 
10.42
 
BioTime Asia, Limited 2010 Stock Option Plan Form of BioTime Asia Limited Stock Option Agreement *
 
 
11

 
 
10.43
 
ReCyte Therapeutics, Inc. 2010 Stock Option Plan Form of ReCyte Therapeutics, Inc. Stock Option Agreement *
 
 
 
10.44
 
Lease, dated October 28, 2010, between SKS Harbor Bay Associates, LLC and BioTime, Inc. *
 
 
 
10.45
 
Memorandum of Tenancy, Renewal of Tenancy and letters of offer and acceptance of renewal of tenancy between ES Cell International Pte. Ltd. and Jurong Town Corporation *
 
 
 
10.46
 
Genome Office Tenancy Renewal, Renewal of Tenancy and letters of offer and acceptance of renewal of tenancy between ES Cell International Pte. Ltd. and Jurong Town Corporation *
 
 
 
21.1
 
List of Subsidiaries *
 
 
 
 
Rule 13a-14(a)/15d-14(a) Certification. **
 
 
 
 
Section 1350 Certification.**
 
1
Incorporated by reference to Registration Statement on Form S-1, File Number 33-44549 filed with the Securities and Exchange Commission on December 18, 1991, and Amendment No. 1 and Amendment No. 2 thereto filed with the Securities and Exchange Commission on February 6, 1992 and March 7, 1992, respectively.

2
Incorporated by reference to Registration Statement on Form S-1, File Number 33-48717 and Post-Effective Amendment No. 1 thereto filed with the Securities and Exchange Commission on June 22, 1992, and August 27, 1992, respectively.

3
Incorporated by reference to BioTime’s Form 8-K, filed April 24, 1997.

4
Incorporated by reference to BioTime’s Form 10-Q for the quarter ended June 30, 1999.

5
Incorporated by reference to BioTime’s Form 10-K/A-1 for the year ended December 31, 2002.

6
Incorporated by reference to BioTime’s Form 8-K, filed December 30, 2004.

 
12

 
 
7
Incorporated by reference to BioTime’s Form 8-K, filed December 20, 2005.

8
Incorporated by reference to BioTime’s Form 8-K, filed January 13, 2006.

9
Incorporated by reference to BioTime’s Form 8-K, filed March 30, 2006.

10
Incorporated by reference to BioTime’s Form 8-K, filed January 9, 2008.

11
Incorporated by reference to BioTime’s Form 10-KSB for the year ended December 31, 2007.

12
Incorporated by reference to BioTime’s Form 10-Q for the quarter ended June 30, 2008.

13
Incorporated by reference to BioTime’s Form 10-Q for the quarter ended September 30, 2008.

14
Incorporated by reference to BioTime’s Form 10-K for the year ended December 31, 2008.

15
Incorporated by reference to BioTime’s Form 8-K filed April 17, 2009.

16
Incorporated by reference to BioTime’s Form 10-Q for the quarter ended March 31, 2009.

17
Incorporated by reference to BioTime’s Form 10-Q for the quarter ended June 30, 2009.

18
Incorporated by reference to BioTime’s Form 10-Q for the quarter ended September 30, 2009.

19
Incorporated by reference to BioTime’s Form 10-Q for the quarter ended March 31, 2010.

20
Incorporated by reference to BioTime’s Form 10-Q for the quarter ended June 30, 2010.

21
Incorporated by reference to BioTime’s Form 8-K filed October 19, 2010.
 
*
Previously filed.
 
**
Filed herewith.
 
 
13

ex10_33.htm

Exhibit 10.33
 
RESEARCH AND EXCLUSIVE LICENSE OPTION AGREEMENT
 
THIS AGREEMENT is made on October 7, 2010 effective subject to the closing of the investment round envisaged in the Share Purchase Agreement (as defined herein) (the date being of such closing being referred to herein as the "Effective Date") between
 
Teva Pharmaceutical Industries Limited, a corporation incorporated under the laws of Israel, located at 5 Basel Street, Petach Tikva 49131, Israel (“Teva”), and
 
Cell Cure NeuroSciences Ltd., a corporation incorporated under the laws of Israel, located at Kiryat Hadassah, Jerusalem 91121, Israel (“Cell Cure”).
 
Teva and Cell Cure may be individually referred to as a “Party” and together as the “Parties”.
 
WHEREAS, Cell Cure is engaged in the development of pharmaceutical preparations embodying human embryonic stem cell and/or human induced pluripotent stem cell-derived Retinal Pigment Epithelial cells ("RPE Cells")  which are non-adherent (in suspension) for use in the Field (as hereinafter defined) (the "Licensed Product"),
 
WHEREAS, Cell Cure is the holder of exclusive licenses  in the Field (as defined herein) from ES Cell International Pte Ltd. (“ESI”), and from Hadasit Medical Research Services and Development Ltd. ("Hadasit"), each covering certain portions of the Cell Cure IP (as defined herein);
 
WHEREAS, Cell Cure wishes to perform an R&D Program (as defined herein) that shall include certain pre-clinical activities as described therein, to be partially funded through Teva’s equity investment in Cell Cure under the Share Purchase Agreement dated October 7, 2010 (the “Share Purchase Agreement”) and additional resources as set forth in the R & D Budget (as defined herein);
 
WHEREAS, the Parties agree that Teva shall have the exclusive option, but not the obligation, to be granted the License (as defined herein), on the terms set out in this Agreement;
 
WHEREAS, the Parties agree that in the event Teva exercises the aforementioned exclusive option to be granted the License, Cell Cure shall grant Teva and Teva shall acquire from Cell Cure, the License, subject to and in accordance with the terms and conditions of this Agreement; and
 
WHEREAS, contemporaneously with the execution of this Agreement Teva shall participate, together with Hadasit Bio-Holdings Ltd. and BioTime, Inc. ("BioTime"), in a round of  equity investment in Cell Cure, as more fully set forth in the Share Purchase Agreement .

 
1

 
 
NOW, THEREFORE, in consideration of the mutual representations, warranties and covenants contained herein, and for other good and valuable consideration the receipt and sufficiency of which are hereby acknowledged, the Parties hereto agree as follows:
 
1.
Definitions and Interpretation
 
 
1.1.
The foregoing preamble and Annexes hereto form an integral part of this Agreement.
 
 
1.2.
In this Agreement the terms below shall bear the respective meanings assigned to them below and other capitalized terms shall bear the respective meanings assigned to them in their parenthetical definition, unless specifically stated otherwise:
 
 
1.2.1.
Affiliate” shall mean, with respect to any Person, any Person directly or indirectly controlling, controlled by or under common control with, such Person.  For purposes of this definition only, “control” of another Person,  shall mean the ability, directly or indirectly, to direct the activities of the relevant organization or entity, and shall include, without limitation (i) ownership or direct control of fifty percent (50%) or more of the outstanding voting stock or other ownership interest of the other organization or entity, or (ii) direct or indirect possession of the power to elect or appoint fifty percent (50%) or more of the members of the governing body of the other organization or entity.
 
 
1.2.2.
Cell Cure IP” shall mean all IP having application in the Field Controlled by Cell Cure as of the Effective Date or at any time following the Effective Date, which is embodied in  Licensed Product or which is necessary or useful in the exercise of the License.
 
 
1.2.3.
Combination Product” shall mean a product which comprises (i) Licensed Product, and (ii) at least one other active ingredient, which, if administered independently of Licensed Product, would have a clinical effect.
 
 
1.2.4.
Competing Product” shall mean any product for the treatment of conditions involving retinal degenerative diseases based on the [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission], other than Licensed Product.
 
 
1.2.5.
Control” or "Controlled", as to IP or materials, shall mean the ownership of IP or materials by a Person or the possession by a Person of the ability to grant a license or sublicense under IP or materials owned or controlled by a third party without violating the terms of any agreement or arrangement between such Person and such third party.
 
 
1.2.6.
Effective Date” shall have the meaning ascribed to it in the preamble of this Agreement.

 
2

 
 
 
1.2.7.
ESI License Agreement” shall mean Exclusive License Agreement between ESI and Cell Cure dated March 22, 2006, as amended, a copy of which is attached hereto as Annex A.
 
 
1.2.8.
Field” shall mean the field of cell replacement therapy of conditions involving retinal degenerative diseases.
 
 
1.2.9.
First Commercial Sale” shall mean, the first commercial sale of  Licensed Product for any indication to a third party, in exchange for cash or some equivalent to which value can be assigned, after obtaining all necessary regulatory and other approvals, including any pricing  approvals that may be required in order to commercially sell and market such Licensed Product in the country in which the sale is made, other than the sale of such Licensed Product for experimental, testing, compassionate or promotional purposes.
 
Notwithstanding anything contained in the foregoing paragraph to the contrary, for the purposes of this definition, the transfer of Licensed Product by Teva or one of its Affiliates, Sublicensees, or Further Sublicensee, to another Affiliate of Teva, Sublicensee or Further Sublicensee, is not a commercial sale, and shall not be taken into account for the purposes of this definition.
 
 
1.2.10.
First Licensed Product” shall mean Licensed Product for the treatment of patients with dry age related macular degeneration (AMD), currently known by the tradename “OpRegen”.
 
 
1.2.11.
Generic Product” shall mean, on a country-by-country basis, a product (i) having the same composition of matter as Licensed Product or which has a marketing approval as a generic product by the regulatory authorities and which could not have been sold or with respect to which a license would have been required to be obtained from Cell Cure, if patent or other exclusivity rights covering such Licensed Product would have been in full force and effect, and  [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission].  However, a product shall not be considered a Generic Product if Teva or anyone on its behalf was involved in its approval or commercialization.
 
 
1.2.12.
“HMO” means Hadassah Medical Organization.
 
 
1.2.13.
“Hadasit License Agreement” shall mean the Research and License Agreement between Hadasit and Cell Cure entered into in 2009, as amended, a copy of which is attached hereto as Annex B.
 
 
1.2.14.
IND” means the designation of Licensed Product as an Investigational New Drug on the basis of a Cell Cure-initiated application as described in 21 C.F.R. Section 312.23, filed for purposes of conducting a Phase I Clinical Trial in accordance with the requirements of the United States Food, Drug and Cosmetic Act of 1938, as amended, and the rules and regulations promulgated thereunder, including all supplements and amendments thereto, which may include, inter alia, managing animal studies, as well as toxicology studies.

 
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1.2.15.
IP” shall mean all vested, contingent and future intellectual property rights including but not limited to: (i) all inventions, materials, compounds, compositions, substances, methods, processes, techniques, know-how, technology, data, information, discoveries and other results of whatsoever nature, and any patents, copyrights, proprietary intellectual or industrial rights directly or indirectly deriving therefrom, as well as provisionals, patent applications (whether pending or not), and patent disclosures together with all reissues, continuations, continuations in part, revisions, extensions, and reexaminations thereof; (ii) all trade marks, service marks, copyrights, designs, trade styles, logos, trade dress, and corporate names, including all goodwill associated therewith; (iii) any work of authorship, regardless of copyrightability, all compilations, all copyrights and (iv) all trade secrets, confidential information and proprietary processes.
 
 
1.2.16.
“Licensed Materials” shall mean the stem cell line(s) and feeder line(s) as Controlled by Cell Cure pursuant to the Hadasit License Agreement, and any clinical grade RPE Cells manufactured by or for Cell Cure based on such cell line(s) and feeder line(s).
 
 
1.2.17.
Net Sales” shall mean the total amounts received by Teva and/or its Affiliates, Sublicensees or Further Sublicensees with respect to  Licensed Product, as established in a bona fide arms-length transaction with an unrelated third party, less the following items (as they apply to such Licensed Product): (i) quantity and/or cash discounts actually allowed or taken; (ii) customs, duties, sales, withholding and similar taxes, if any, imposed on such Licensed Product, to the extent applicable to such sale and included in the invoice with respect to such sale; (iii) amounts actually allowed or credited by reason of rejections, return of goods (including as a result of recalls), any retroactive price reductions or allowances specifically identifiable as relating to such Licensed Product (including those resulting from inventory management or similar agreements with wholesalers); (iv) amounts incurred resulting from government mandated rebate programs (or any agency thereof); (v) third party (a) rebates, (b) freight, postage, shipping and applicable insurance charges, to the extent same are separately itemized on invoices and actually paid as evidenced by invoices or other appropriate supporting documentation, and (c) chargebacks or similar price concessions related to the sale of such Licensed Product; and  (vi) reasonable quantities of samples, [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission]. All of the foregoing shall be calculated in accordance with U.S. GAAP.

 
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Notwithstanding anything contained in the foregoing paragraph to the contrary, for the purposes of this definition, the transfer of Licensed Product by Teva or one of its Affiliates to another Affiliate of Teva or a Sublicensee or Further Sublicensee is not a sale; in such cases, Net Sales shall be determined based on the total amounts received by Teva and/or its Affiliates, Sublicensees or Further Sublicensees with respect to Licensed Product first sold by them to independent third-parties, less the deductions permitted herein.
 
[*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission].
 
For sales which are not at bona fide arms-length and/or are not in the ordinary course of business, the term “Net Sales” shall mean the total amount that would have been due in an arms-length sale made in the ordinary course of business and according to the then current market conditions for such sale or, in the absence of such current market conditions, according to market conditions for sale of products similar to Licensed Product.
 
If Licensed Product is sold or supplied in a currency other than United States Dollars then the sum of Net Sales shall first be determined in the currency in which such Licensed Product was invoiced and then converted into equivalent United States Dollars at the middle market rate of such foreign currency as quoted in the Financial Times at the close of business of the last business day of the quarter in which the payment is made.
 
 
1.2.18.
OpRegen Plus” shall mean a product embodying human embryonic stem cell-derived RPE cells that are supported on or within a membrane instead of in suspension for use in the Field.
 
 
1.2.19.
OCS” shall mean the Office of Chief Scientist of the Ministry of Industry, Trade and Labor.
 
 
1.2.20.
Patents” shall mean patent applications and patents which may be granted thereon included within the Cell Cure IP; which include, continuations, continuations-in-part, patents of addition, divisions, renewals, reissues and extensions (including any patent term extension) of any of the aforegoing patents. As of the Effective Date, the Patents include all patents and patent applications listed in Annex C attached hereto.

 
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1.2.21.
Person” shall mean any person, organization or entity.
 
 
1.2.22.
Phase I Clinical Trial” shall mean, as to a particular product for a particular indication, the initial controlled and lawful study in humans of the safety of such product for such indication, which is prospectively designed to generate data to support commencing a Phase II Clinical Trial of such product for such indication.
 
 
1.2.23.
Phase II Clinical Trial” shall mean, as to a particular product for a particular indication, the initial controlled and lawful study in humans of the safety, dose ranging and efficacy of such product for such indication, which is prospectively designed to generate data to support commencing a Phase III Clinical Trial of such product for such indication.
 
 
1.2.24.
Phase III Clinical Trial” shall mean, as to a particular product for a particular indication, the initial controlled and lawful study in humans of the safety and efficacy of such product for such indication, which is prospectively designed to demonstrate statistically whether such product is safe and effective for use for such indication in order to file an application for regulatory approval with respect to such product for such indication.
 
 
1.2.25.
Pre-Clinical Activities” shall mean those activities required by the FDA to be undertaken in order to file an IND.
 
 
1.2.26.
R&D Budget” shall mean the budget shown on the R&D Program.
 
 
1.2.27.
R&D Program” shall mean the program attached to the Share Purchase Agreement as Schedule 5.1 and attached hereto as Annex D.

 
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1.2.28.
Royalty Term” shall mean on a country by country  basis (per approved indication) the period commencing upon the First Commercial Sale of such Licensed Product in the relevant country and expiring on the later of: (i) fifteen (15) years after that date, or (ii) the expiry in that country of all Valid Patent Claims covering Licensed Product.
 
 
1.2.29.
Sublicense” shall mean any right granted, license given, or agreement entered into, by Teva and/or its Affiliates and/or Sublicensees to or with any other person or entity (whether or not such grant of rights, license given or agreement entered into is described as a sublicense or otherwise), permitting any use of the Cell Cure IP (or any part thereof) or any right to research, develop, make, have made, register, import, manufacture, use, sell, offer for sale, produce, sublicense, commercialize and/or distribute  Licensed Product for any indication in the Field. The term “Sublicensee” shall be construed accordingly.
 
 
1.2.30.
Sublicensing Receipts” shall mean consideration of any kind whether monetary or otherwise, received by Teva or its Affiliates for or in connection with the grant of Sublicenses and/or options for Sublicenses, including, one time, lump sum or other payments, except for: (i) gross receipts for commercial sales of Licensed Product that are subject to royalty payments to Cell Cure; (ii) amounts received  from a Sublicensee solely to finance research and development activities to be performed by or on behalf of Teva in connection with such Sublicense (as evidenced by itemized invoices, receipts or other supporting documentation); or (iii) payments received in reimbursement for patent expenses incurred at any time after the date of the grant of the sublicense.
 
 
1.2.31.
Territory shall mean worldwide.
 
 
1.2.32.
Teva’s Representative” shall mean [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] or any other person designated in writing by Teva in her place.
 
 
1.2.33.
Valid Patent Claim” shall mean a claim of an issued and unexpired Patent licensed to Teva under this Agreement, which has not been revoked or held unenforceable, unpatentable or invalid by a decision of a court or other governmental agency of competent jurisdiction, unappealable or unappealed within the time allowed for appeal, and which has not been disclaimed, denied or admitted to be invalid or unenforceable through reexamination, reissue, disclaimer or otherwise. For the purposes hereof, “Valid Patent Claim” shall include any patent term extension such as but not limited to supplementary protection certificates pursuant to Council Regulation (EEC) No. 1768/92, any Pediatric Exclusivity Extension, and foreign equivalents of any of the foregoing relating to such patents.

 
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1.3.
In this Agreement, words importing the singular shall include the plural and vice-versa, words importing any gender shall include all other genders, and references to persons shall include partnerships, corporations and unincorporated associations.
 
 
1.4.
The words “including” and “includes” mean including, without limiting the generality of any description preceding such terms.
 
 
1.5.
In the event of any discrepancy between the terms of this Agreement and any of the Annexes hereto, the terms of this Agreement shall prevail.
 
 
1.6.
Section, paragraph and annex headings shall not affect the interpretation of this Agreement.
 
2.
The R&D Program
 
 
2.1.
The R&D Program
 
 
2.1.1.
Cell Cure shall carry out the Pre-Clinical Activities in accordance with the R&D Program and R&D Budget.
 
 
2.1.2.
Cell Cure hereby reconfirms its agreement to utilize certain funds as set forth under Section 5.1 of the Share Purchase Agreement, solely to cover the R&D Budget for carrying out the R&D Program (directly or through Hadasit or other subcontractors) in accordance with Section 2.1.12 below.
 
 
2.1.3.
Cell Cure shall keep separate records of the expenses which it incurs in undertaking the R&D Program and shall provide Teva with detailed reports of Cell Cure’s expenditures not less often than on a calendar quarter basis.
 
 
2.1.4.
For the avoidance of doubt, (i) save as provided in Section 7.5 of the Hadasit License Agreement for purposes of initial evaluation, any use of third party technology by Cell Cure for the purposes of the performance of the R&D Program other than as already licensed or sub-licensed in from ESI and Hadasit; and/or (ii) any in-licensing of additional third party technology by Cell Cure for the purposes of the performance of the R&D Program other than as already licensed-in from ESI and Hadasit, shall require the prior written agreement of Teva .

 
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2.1.5.
At the end of each calendar quarter during the course of the R&D Program, Cell Cure shall provide Teva with periodic progress reports regarding the progress of the R&D Program and the extent of the utilization of the R&D Budget, in a form and containing the substance to be agreed in advance by the Parties and supplements to the R&D Program providing more detailed programs per each stage of development.
 
 
2.1.6.
Any Material Deviation (as defined below) from the R&D Program and the R&D Budget shall require the prior written consent of the Teva Representative.  For the purposes of this Section 2.1.6 "Material Deviation" shall mean a change in the R&D Program which can reasonably be foreseen as impacting the timetable by more than [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] or triggering a deviation from the current R&D Budget by more than [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission].
 
 
2.1.7.
Cell Cure shall notify Teva, as soon as it becomes aware of any impending budget overruns that would result in Cell Cure exhausting the amounts and resources shown in the R&D Budget, but not later than [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] in advance. In such event, Cell Cure shall fund the first [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] of such overruns (“Cell Cure’s Participation”), and thereafter Teva shall continue funding the R&D Program through to the IND becoming effective.
 
 
2.1.8.
Not later than thirty (30) days after the completion of the Pre-Clinical Activities, unless otherwise agreed by Teva in writing, Cell Cure shall provide Teva with a report summarizing the Pre-Clinical Activities in the context of the R&D Program, and the results of same, in a form and substance to be agreed by the Parties (the “Final Pre-Clinical Report”).
 
 
2.1.9.
Teva may, from time to time, request updates regarding the progress of the R&D Program, in addition to the periodic progress reports, and Cell Cure shall provide any additional update that Teva may reasonably request.
 
 
2.1.10.
After receipt by Teva of the Final Pre-Clinical Report, if Teva wishes to receive further information from Cell Cure it shall so advise Cell Cure by written notice specifying the additional information requested, to be delivered to Cell Cure no later than forty-five (45) days after the date of the provision to Teva of the Final Pre-Clinical Report. Cell Cure shall provide such additional information within a reasonable time, but no later than thirty (30) days following receipt of Teva's notice (the "Initial Response"). If following receipt of the Initial Response Teva wishes to receive further information from Cell Cure, it shall so advise Cell Cure by written notice within a reasonable time, but no later than forty five (45) days from receipt of the Initial Response, specifying such additional information requested, and Cell Cure will provide such additional information within a reasonable time but no later than thirty (30) days following receipt of Teva's additional notice. Other than as set forth above, Cell Cure shall not be required to provide Teva with any additional information in connection with the Final Pre-Clinical Report.

 
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2.1.11.
Cell Cure shall perform its obligations under the R&D Program in accordance with all applicable laws, rules and regulations, and shall procure the receipt of all approvals and consents necessary for the performance thereof.
 
 
2.1.12.
For the avoidance of doubt, Cell Cure shall be entitled to subcontract its obligations to perform any task under the R&D Program to Hadasit and, subject to prior consultation with the Teva Representative, to other third parties.
 
 
2.1.13.
The Parties hereby acknowledge that Cell Cure has not guaranteed that the R&D Program will be successful or achieve any specific results at all or within the specified time period.
 
 
2.2.
Teva’s Option; Option to license OpRegen Plus
 
 
2.2.1.
From the Effective Date and for a period of [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] days following the IND becoming effective, and provided that Teva is in compliance with its undertaking pursuant to Section 2.1.7 above (the "Option Period"), Teva shall have the exclusive right, but not the obligation (the “License Option”), to receive a sole and exclusive, royalty-bearing, license to use the Cell Cure IP to research, develop, make, have made, register, import, manufacture, use, sell, offer for sale, produce, commercialize and distribute Licensed Product for all indications in the Field in the Territory and for no other purpose whatsoever, and to sublicense any such activities in accordance with the provisions herein (the “License”). For the avoidance of doubt, the term “exclusive” in the context of the Cell Cure IP means that Cell Cure shall not grant such rights and licenses in the Cell Cure IP in the Field to a third party or exercise such rights itself, but that Cell Cure shall be free, however, to utilize and license  the Cell Cure IP for any purpose outside of the Field; provided however that nothing herein shall derogate from the rights retained by Hadasit, for itself, HMO and their respective researchers, employees, students and other researchers at collaborating research institutions (A) within the Field, to: (i) practice the Licensed Technology (as defined in the Hadasit License Agreement) and to use the Licensed Materials solely for HMO's own internal academic and non-commercial research and instruction, and (ii) license or otherwise convey to other academic and not-for-profit research organizations (for no charge other than customary expense coverage and the like, in accordance with the MTA mentioned below), provided that such Licensed Technology will be transferred pursuant to an MTA substantially in the form attached hereto as Annex G and subject to the prior written consent of Cell Cure and Teva, which consent will not be unreasonably withheld, and (B) utilize and license/commercialize the Licensed Technology and the Licensed Materials for any purpose outside of the Field, without restriction.

 
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2.2.2.
If Teva elects to exercise the License Option, it shall provide written notice of its decision to Cell Cure prior to the expiration of the Option Period (the “License Notice”), and as of the date of the provision of the License Notice, the grant of the License to Teva shall become effective.
 
 
2.2.3.
Prior to the expiration of the Option Period, Teva’s representatives shall have the right, upon reasonable notice, to audit Cell Cure’s Licensed Product- related documentation for the sole purpose of conducting due diligence in relation to the First Licensed Product, and deciding whether or not to exercise the License.
 
 
2.2.4.
During the term of this Agreement, Cell Cure shall not, without Teva’s prior written consent: (i) discuss, negotiate or enter into any agreement, arrangement or commitment according to which a third party is granted any right in the Territory with respect to   Licensed Product, (ii) take any action which may derogate from or conflict with, or refrain from taking any action which is necessary to preserve, the License Option, (iii) enter into any agreement, arrangement or commitment that would derogate from or conflict with the rights granted to Teva pursuant to Section 2.2.
 
 
2.2.5.
This Agreement shall terminate at the end of the Option Period if Teva has not served the License Notice within the Option Period. In such event, or in the event of the termination of the Option by reason of Teva’s failure to fund the R&D Program pursuant to Section 2.1.7 above, other than the obligations set forth in Sections 14 (Confidentiality) and 10 (Term and Termination), and such other obligations intended to survive termination or expiry of this Agreement pursuant to Section 10.7, the Parties shall not be obligated in any manner towards each other under this Agreement.

 
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2.2.6.
Cell Cure hereby grants Teva the right to an option to license OpRegen Plus on the same terms as the License (the “OpRegen Plus Option”), subject to the following: If and when Cell Cure achieves a proof of concept of OpRegen Plus in RCS rats or the equivalent (on a level similar to the proof of concept achieved in respect of the First Licensed Product prior to the execution of this Agreement), then it shall present such results along with a development plan and budget to Teva. Teva shall have ninety (90) days following such presentation, to determine its interest in attaining the OpRegen Plus Option on the same terms as the License, it being understood and agreed that as from the grant of the OpRegen Plus Option by Cell Cure to Teva, at Teva’s request, the costs of all further development of OpReGen Plus shall be borne by Teva (subject to any available grants), without Teva being entitled to receive any shares in return. Should Teva confirm its interest within such ninety (90) day period, the Parties shall enter into an agreement whereby Cell Cure shall grant Teva the OpRegen Plus Option on the same terms as the License. The provision of Section 2.2.3 and 2.2.4 above shall apply, mutatis mutandis, for as long as Teva has rights under this Section 2.2.6. For the avoidance of doubt, the rights granted to Teva pursuant to this Section 2.2.6 shall automatically expire upon the termination of this Agreement without an additional research and exclusive option license agreement pertaining to OpRegen Plus having been previously signed.  Any such agreement so signed shall enter into and remain in force in accordance with its terms.
 
3.
License Grant
 
 
3.1.
Subject to (i) Teva serving the License Notice in accordance with Section 2.2.2 (ii) payment of the Milestone Payment set forth in Section 5.1(a) below, (iii) reimbursement of Cell Cure’s Participation, if any; and (iv) approval of the OCS  and the Israeli Ministry of Health to the License to Teva and the transfer of Licensed Materials to Teva, to the extent applicable, Cell Cure hereby grants Teva the License and Teva hereby accepts the License from Cell Cure. For the removal of doubt, Teva shall not be entitled to use the Cell Cure IP or the Licensed Materials for any purpose other than the exploitation of the License.  Following the exercise of the License Option Teva shall have the right to require the transfer of the Licensed Materials from Cell Cure to Teva for purposes of conducting clinical trials and otherwise exploiting the License as permitted hereunder, and Cell Cure shall transfer the Licensed Materials to Teva, subject to receipt of the abovementioned approvals, this Section 3.1 and other applicable provisions of this Agreement.  Prior to receipt of Licensed Materials, Teva and/or its Sublicensees and/or Further Sublicensees shall undertake to commit in writing to HMO (A) to report to HMO, in advance, in accordance with the guidelines of the Institution Review Board of HMO (Helsinki Committee), regarding any potential and/or planned use of the Licensed Materials and (B) to comply with such licenses, permits, approvals, and consents, including the requirements set out in the approvals of the Ethics Committee for Genetic Studies in Humans of the MOH (the “MOH Ethics Committee”) as issued in relation to each particular activity/study using Licensed Materials from time to time, by Teva and/or its Sublicensees and/or its Further Sublicenses, including, the development, manufacture, use and sale of Licensed Product. The Company undertakes to request copies of all such licenses, permits, approvals and consents and to provide the same to Teva.

 
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3.2.
If Teva informs Cell Cure that any IP Controlled by Hadasit, ESI or BioTime which does not constitute part of the Cell Cure IP, is reasonably required to be licensed to Teva in order for Teva to commercialize  Licensed Product, then Cell Cure shall use its best efforts to assist Teva to obtain licenses to such IP for such purpose.
 
 
3.3.
Teva shall have the right to grant (whole or partial) Sublicenses to third parties, and such third parties shall be entitled to grant further sublicenses (each, a “Further Sublicense” and the term “Further Sublicensee” shall be construed accordingly) and so on under the License, on terms and conditions consistent with the terms of this Agreement, and Teva shall be entitled to determine the commercial terms of any such Sublicense. The grant of any Sublicenses and Further Sublicenses shall not relieve the Parties of or reduce their obligations under this Agreement.  The term of any Sublicense shall be limited to the term of the License and will terminate upon the termination of the License for any reason whatsoever, other than due to a lapse of time. Teva shall provide Cell Cure with an executed copy of each Sublicense agreement (including any Further Sublicense agreements – to the extent available to Teva) provided that Teva may redact information or parts of any such agreement that are not material to Cell Cure or that are subject to obligations of confidentiality, within thirty (30) days of execution of the relevant Sublicense agreement and shall require any Sublicensee to do the same.
 
 
3.4.
Without limiting the foregoing or any of Teva’s obligations under this Agreement relating to the grant of Sublicenses or Further Sublicenses, Teva shall be entitled to subcontract the conduct or performance of any activity concerning the research, development, testing or manufacturing of Licensed Product to a third party (who will not have any right to sell Licensed Product), and such subcontract shall not be considered to be a grant of a sublicense for purposes of the preceding Section 3.3. For the avoidance of doubt, Teva shall be fully responsible for the adherence by such subcontractor with the relevant terms of this Agreement.
 
 
3.5.
Throughout the term of this Agreement Cell Cure will not directly or indirectly (through licensees or otherwise), be engaged in the development, manufacture, marketing, sale or any other manner of commercialization of Licensed Product other than under this Agreement.

 
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3.6.
Following the exercise of the Option and upon entering the stage of clinical trials Teva will strive to perform the initial phases I/IIa study at the [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission].
 
 
3.7.
Subject to Teva’s compliance with its obligations pursuant to Section 14 (Confidentiality), nothing contained herein shall be construed to impose any limitation on Teva or its Affiliates to develop, manufacture, market or commercialize any Competing Product or any other product; provided only that Teva agrees that in the event that Teva is involved in the marketing of a Competing Product, Teva shall perform such marketing activities either through a third party or through a sales force within the Teva group that is separate from the sales force that markets Licensed Product.
 
4.
Development and Commercialization of Licensed Product
 
 
4.1.
Subject to Teva exercising the License Option by serving the License Notice on Cell Cure pursuant to Section 2.2.2, Teva undertakes at its own expense to make such commercially reasonable efforts, throughout the terms of this Agreement,  to further develop, register, manufacture, have manufactured, commence commercial sales, make ongoing sales and otherwise commercialize  Licensed Product [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission].
 
 
4.2.
Subject to Teva exercising the License Option as aforesaid, Teva shall have responsibility for undertaking  further development of Licensed Product and preparing, submitting, seeking approval of, maintaining and updating marketing approval applications, marketing approvals and other regulatory approvals and applications for regulatory approvals with respect to Licensed Product.  Teva will solely own, apply for and be the holder or owner of record for all applications and approvals relating to Licensed Product.  Subject to  Teva exercising the License Option as aforesaid, Teva will be solely responsible for commercializing Licensed Product during the term of this Agreement, including, without limitation, manufacture, marketing, promotion, patient assistance programs, medical education, price negotiation and setting, reimbursement negotiation, customer relations, sales, order processing, invoicing and collection, preparation of sales records and reports, warehousing, inventory management, logistics and distribution (including, without limitation, the handling of returns, market withdrawals, field corrections and recalls) and other commercialization activities.
 
 
4.3.
Teva shall provide Cell Cure with notices regarding main regulatory filings with respect to Licensed Product, and reports relating to the material activities described in Section 4.2 for the preceding six (6) month period, on a semi-annual basis.
 
 
4.4.
For the avoidance of doubt, nothing contained in this Agreement shall be construed as a warranty by Teva that any efforts to be made by Teva pursuant to this Agreement, including without limitation any development or any commercialization to be carried out by Teva pursuant to this Agreement, will actually achieve their aims or any other results or succeed, and Teva makes no warranties whatsoever as to any results to be achieved in consequence of the carrying out of any such development, commercialization, efforts or activities.  Furthermore, Teva makes no representation to the effect that the commercialization of Licensed Product will succeed, or that Teva will be able to sell a particular quantity of Licensed Product.

 
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4.5.
Notwithstanding the foregoing, subject to Teva exercising the License Option as aforesaid, Cell Cure shall, at Teva’s request, transfer the technology as developed and tested in the course of the R&D Program for the commercial production of RPE Cells based on the Licensed Materials, from Cell Cure to Teva or its contract manufacturer, subject to the terms and conditions of this Agreement, in which case Teva shall bear all of the out-of-pocket expenses of Cell Cure in carrying out such technology transfer and shall also compensate it for time expended by its staff at an agreed rate per man day .For the avoidance of doubt, such technology transfer shall not include design engineering services or the construction or adaptation of any facility. Moreover, it is understood and agreed that the supply of RPE Cells to Teva and/or the transfer of technology by Cell Cure to Teva pursuant to this Section 4.5 shall be for the sole purpose of the exercise by Teva of the License granted hereunder and such RPE Cells, technology and technical documentation that may be so provided by Cell Cure to Teva may be utilized by Teva solely as permitted hereunder. All such technical documentation shall be treated as Confidential Information of Cell Cure pursuant to Section 14.
 
5.
Milestones, Royalty Payments, Generic Royalty Payments and Sublicensing Fees
 
 
5.1.
In consideration for the grant of the License, Teva shall make the following payments to Cell Cure upon achievement of the relevant milestones (each, a “Milestone”) (the “Milestone Payments”):
 
 
(a)
Upon delivery by Teva of the License Notice —[*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission];
 
 
(b)
Upon the first actual delivery/administration of Licensed Product to the first patient participating in the Phase II Clinical Trials with respect to Licensed Product — [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission];
 
 
(c)
Upon the first actual delivery/administration of Licensed Product to the first patient participating in the Phase III Clinical Trials with respect to Licensed Product — [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission];

 
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(d)
Upon the First Commercial Sale in the US — [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission]; and
 
 
(e)
Upon First Commercial Sale in the EU — [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission].
 
For the sake of clarity: (i) the amount listed above for each Milestone Payment is the total final amount to be paid by Teva for each Milestone, (ii) the second and third indications of the Licensed Product shall trigger a Milestone Payment only under (d) and (e) above, and (iii) any additional indication of the Licensed Product after the first shall not trigger any Milestone Payment other than as indicated in (ii) above.
 
 
5.2.
In addition, in consideration for the grant of the License, Teva shall, throughout the Royalty Term, pay to Cell Cure royalties at the following rates on annual Net Sales, during each calendar year (the “Royalty Payments”), as specified in this Section 5.2 below:
 
 
(a)
6% (six percent) [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission];
 
 
(b)
7% (seven percent) [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission];
 
 
(c)
8% (eight percent) [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission];
 
 
(d)
9% (nine percent) [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission]; and
 
 
(e)
10% (ten percent) [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission].
 
 
5.3.
During the Royalty Term, from such time as a Generic Product is commercialized and distributed in any particular country by a third party unrelated to Teva, Teva shall pay Cell Cure as of such date and for as long as any Generic Product is so sold in such country, reduced Royalties for Licensed Product sold in such country at rates half of those set out in Section 5.2 on Net Sales of Licensed Product in such country (“Generic Royalty Payments”).  The reductions set out in this Section 5.3 shall be spread pro rata over each of the sub section levels of royalty payments. It is understood and agreed, however, that the reductions in Royalties set out in this Section 5.3 shall not apply, if and for as long as Teva, its Affiliates, Sublicensees or Further Sublicensees or any one on behalf of any of the foregoing is selling a Competing Product in such country.

 
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5.4.
Notwithstanding the foregoing, in the event that Licensed Product is sold in the form of a Combination Product, then the proportion of such Combination Product to be attributed to Net Sales that are subject to Royalty Payments or Generic Royalty Payments (the “Relevant Proportion”) shall be calculated as provided below, on a country by country basis: [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission]
 
 
5.5.
In addition to any other payments Teva is required to make to Cell Cure, during the term of this Agreement, Teva will pay Cell Cure [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] of any Sublicensing Receipts (the “Sublicensing Fees”). [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission]
 
 
5.6.
For the removal of doubt, in calculating amounts received by Teva or its Affiliates, whether by way of Net Sales, Generic Royalty Payments or Sublicensing Receipts, any amount deducted or withheld in connection with any such payment on account of taxes on net income (including income taxes, capital gains tax, taxes on profits or taxes of a similar nature) payable by Teva or its Affiliates in any jurisdiction, shall be deemed, notwithstanding such deduction or withholding, to have been received by Teva or its Affiliates.
 
 
5.7.
Following the expiry of the Royalty Term for Licensed Product for a particular indication in a particular country in the Territory, Teva shall have a perpetual fully paid up license to continue to exploit the License in respect of such indication without having to pay Royalty Payments, Generic Royalty Payments or Sublicensing Fees with respect to such Licensed Product in such country.
 
6.
Payment Terms and Reporting with respect to the License
 
 
6.1.
Upon the achievement of the First Commercial Sale or the first Sublicense and for the duration of the Royalty Term, Teva shall submit to Cell Cure, no later than [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] after the end of each calendar quarter, quarterly reports setting out all amounts owing to Cell Cure with respect to the calendar quarter to which the report refers with respect to Licensed Product, including: (i) the Net Sales made by Teva and its Affiliates, Sublicensees and Further Sublicensees, including a breakdown of Net Sales according to country and currency of sales, (ii) total Milestone Payments Sublicensing Receipts, Royalty Payments and Sublicensing Fees and Generic Royalty Payments due to Cell Cure with respect to such calendar quarter or, if no such payments are due to Cell Cure with respect to such calendar quarter, a statement that no payments are due; and (iii) any calculations made in relation to Combination Products and the Generic Royalty Payments.  Each such report shall be signed by the relevant financial executive of the relevant division of Teva.

 
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6.2.
The Parties agree that all information which Teva provides to Cell Cure pursuant to Section 6.1 shall be treated as Confidential Information for the purposes of Section 14.
 
 
6.3.
All amounts payable by Teva to Cell Cure pursuant to Section 5 shall be paid to Cell Cure (i) with respect to Royalty Payments and Generic Royalty Payments, on a quarterly basis, and no later than [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] after the end of each calendar quarter, commencing with the first calendar quarter in which Net Sales are made, and (ii) with respect to Milestone Payments and Sublicensing Fees, within [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] following the end of the month in which the applicable Milestone was achieved or the Sublicensing Receipts were received.
 
 
6.4.
Each payment due to Cell Cure pursuant to Section 5 shall be paid by Teva by wire transfer of immediately available funds to an account designated by Cell Cure in writing.
 
 
6.5.
Teva shall maintain and shall cause its Affiliates to maintain, complete and accurate records of Licensed Product sold under this Agreement, and any amounts payable to Cell Cure in relation to such Licensed Product, which records shall contain information to reasonably permit Cell Cure to confirm the accuracy of any payments made to Cell Cure.
 
 
6.6.
Teva shall retain and shall cause its Affiliates to retain such records relating to each calendar year during the Royalty Term for [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] after the conclusion of that calendar year, during which time Cell Cure shall have the right, at its expense to cause an independent, certified public accountant (which accountant may not be compensated on a full or partial contingency basis) to inspect such records during normal business hours for the sole purpose of verifying any payments delivered under this Agreement.  Such accountant shall not disclose to Cell Cure any information other than information relating to the accuracy of reports and payments delivered under this Agreement.  In the event that any audit performed pursuant to this Section 6.6 reveals an underpayment in excess of [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] in any calendar year, and if such underpayment is proven to the satisfaction of a mutually agreed external auditor (it being agreed that absent such mutual agreement as to the identity of the auditor within thirty (30) days of a Party’s written notice to the other that it wishes to have such external auditor appointed, the external auditor shall be one of the ‘big four’ accounting firms), then Teva shall bear the full cost of such audit.  Cell Cure may exercise its right of audit under this Section 6.6 only once for every calendar year and only once per calendar year for any year ending not more than thirty six (36) months prior to the date of such audit, and with reasonable prior notice to Teva and the relevant Affiliate, and subject to prior coordination.  Any such audit shall not unreasonably interfere with the business of Teva or the relevant Affiliate, and shall be completed within a reasonable timeframe.  Teva shall promptly transfer to Cell Cure any payment due pursuant to such audit or mutually agreed external audit, as applicable.

 
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6.7.
Without derogating from the provisions of the preceding Section 6.6, Cell Cure   shall have the right to request that Teva inspect records of its Sublicencees and Further Sublicensees, for the sole purpose of verifying any payments delivered under this Agreement, in which case Teva shall exert its reasonable commercial efforts to perform such audit. In the event that any audit performed under this Section 6.7 reveals an underpayment in excess of [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] and if such underpayment is proven to the satisfaction of a mutually agreed external auditor (to be appointed in accordance with the procedure set out in Section 6.6 above), then Teva shall bear the full cost of such audit and in any other case the out of pocket costs of such audit shall be borne by Cell Cure. Cell Cure may exercise its rights under this Section 6.7 only once for every calendar year and only once every year ending not more than thirty six (36) months prior to the date of such audit.
 
 
6.8.
Teva or Cell Cure, as applicable, shall immediately pay to the other Party any underpayment or overpayment discovered pursuant to either of Section 6.6 or 6.7 above, together with interest at [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission].
 
 
6.9.
Teva shall provide Cell Cure [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] a written periodic report concerning all material activities undertaken in respect of the exercise of the License and/or the use of Licensed Materials furnished to Teva hereunder if conducted outside of Hadasit/HMO (“Development Reports”). The Development Reports shall include a summary of the research progress, a detailed report of the testing results regarding the Licensed Materials, and any other related work affected by any Affiliate or Further Sublicensee during the 6 (six) month period prior to the report. Development Reports shall also set forth a general assessment regarding the achievement of any milestones, the projected – or actual – completion date of the development of Licensed Product and the marketing thereof and sales forecasts, if any have been made in the regular course of Teva’s business. The Parties agree that all information which Teva provides to Cell Cure pursuant to this Section 6.9 shall be treated as Confidential Information for the purposes of Section 14.

 
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7.
Intellectual Property Rights
 
 
7.1.
As between the Parties, Teva acknowledges Cell Cure’s Control of the Cell Cure IP.
 
 
7.2.
If during the term of this Agreement, and subject to Teva exercising the License Option, any Affiliate of Cell Cure, or any company with which Cell Cure merges (if such shall exist), shall license to Cell Cure any IP that would be necessary or useful in the exercise of the License, then Cell Cure shall immediately notify Teva of such IP and same shall be deemed as part of the Cell Cure IP, at no additional cost to Teva.
 
 
7.3.
As between the Parties, all IP relating to Licensed Product which is developed by or on behalf of Teva on or after the date on which Teva serves the License Notice, other than Cell Cure IP, shall be exclusively owned by Teva, and Teva shall have all right, title and interest thereto (the “Teva IP”).
 
 
7.4.
Each Party agrees to sign, execute and deliver all documents and papers that may be required, and perform such other acts as may be reasonably required in order to ensure the assignment to Cell Cure of the Cell Cure IP and the assignment to Teva of the Teva IP and any registration of the License with the relevant authorities anywhere in the world.
 
 
7.5.
For the avoidance of doubt, Cell Cure shall be fully and solely responsible for all payments to Hadasit under the Hadasit License Agreement and to ESI under the ESI License Agreement as well as to BioTime in relation to any patent that may be granted to BioTime under its patent application App. no.:12/504,630 entitled: "Methods to Accelerate the Isolation of Novel Cell Strains from Pluripotent Stem Cells and Cells Obtained Thereby” filed on July  16, 2009, should such technology be required for the exploitation of the License, and Teva shall be fully and solely responsible for any and all other royalty payments which may be due by reason of the exploitation of the License by Teva, its Affiliates, Sublicensees or Further Sublicensees.
 
8.
[*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission]
 
 
8.1.
[*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission]
 
 
8.2.
[*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission]

 
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8.3.
[*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission]
 
 
8.4.
[*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission]
 
 
8.5.
[*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission]
 
 
8.6.
[*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission]
 
 
8.7.
[*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission]
 
 
8.8.
[*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission]
 
 
8.9.
[*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission]
 
 
8.10.
[*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission]
 
 
8.11.
[*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission]
 
 
8.12.
[*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission]
 
General
 
 
8.13.
The Parties agree to provide each other with reasonable cooperation in the defense of any claims brought against the other Party in connection with the substance of this Agreement and shall join any such litigation as a party if required by law. The Parties agree to execute all documents reasonably necessary for the relevant Party to defend such action and shall provide documents and help with making contact with witnesses that are or were their employees, consultants or otherwise connected to them, whose assistance or testimony is necessary in the reasonable judgment of the lawyers who conduct of the proceedings.
 
 
8.14.
In no event shall either Party enter into any settlement, consent order, consent judgment or any voluntary disposition of such action that would adversely affect the rights of the other without the prior written consent of such other Party, which consent shall not be unreasonably withheld or delayed.

 
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9.
Representations and Warranties
 
 
9.1.
Each Party hereby represents and warrants to the other Party that:
 
 
9.1.1.
it has the full power and authority to enter into this Agreement and to perform its obligations hereunder, and all corporate approvals required have been obtained;
 
 
9.1.2.
it is a limited liability corporation duly organized, validly existing under the laws of Israel and it has all necessary corporate power and authority to carry on its business as currently conducted or proposed to be conducted; and
 
 
9.1.3.
entering into this Agreement shall not constitute a breach of any agreement, contract, understanding and/or obligation, including such Party’s documents of incorporation which it is currently bound by, and as long as this Agreement is in effect and without derogating from the rights to terminate the Agreement pursuant to Section 10 below, such Party shall not undertake any obligations which conflict with its obligations under this Agreement.
 
 
9.2.
In addition, Cell Cure hereby represents and warrants that:
 
 
9.2.1.
the First Licensed Product is being developed under the licenses granted to Cell Cure pursuant to the ESI License Agreement and the Hadasit License Agreement and no additional agreements with third parties;
 
 
9.2.2.
it Controls and shall Control the Cell Cure IP during the term of this Agreement and that its rights thereto shall remain free and clear of any pledge, encumbrance or lien whether arising by contract, agreement or by operation of law or order of a court;
 
 
9.2.3.
it shall refrain from committing any act or omission which would constitute a breach under the ESI License Agreement or the Hadasit License Agreement;
 
 
9.2.4.
to the best of its knowledge the performance of Cell Cure’s obligations under this Agreement do not and will not infringe any third party IP rights;
 
 
9.2.5.
to the best of its knowledge and without enquiry, the exploitation by Teva of the License shall not infringe any third party IP rights, other than potentially those of Wisconsin Alumni Research Foundation (WARF) and Advanced Cell Technology (ACT);
 
 
9.2.6.
it has the right and authority to grant the License Option and the License;

 
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9.2.7.
it has no knowledge of any legal suit or proceeding by any third party against Cell Cure contesting the ownership or validity of the Cell Cure IP or any part thereof or contesting the possible exploitation of the License (including as it relates to the commercialization of  Licensed Product);
 
 
9.2.8.
it has the necessary experience and expertise to manage the R&D Program and to perform the R&D Program  through external sources;
 
 
9.2.9.
in carrying out its obligations and responsibilities pursuant to this Agreement it shall obtain or procure all necessary approvals and consents and shall comply with all applicable laws and regulations, licenses, permits, approvals and procedures, including without limitation, the approval of the OCS to the grant of the License, if required;
 
 
9.2.10.
the current approval for carrying out the R & D Program through Hadasit at HMO is attached hereto as Annex I;
 
 
9.2.11.
it has paid all maintenance and other required fees related to the Patents;
 
 
9.2.12.
it shall not, during the term of this Agreement, perform any work or other activities or grant rights to a third party on or in connection with Licensed Product, except in accordance with the R&D Program and this Agreement; and
 
 
9.2.13.
it is not aware, as of the date hereof, of any use of the “Materials” (as such term is defined in the Hadasit License Agreement by the current members of the Bereshith Consortium which is contradictory to the Cell Cure’s rights thereunder.
 
 
9.3.
In addition, Teva hereby represents, warrants and covenants that:
 
 
9.3.1.
Teva is aware that Cell Cure has received funding for the development of the First Licensed Product from the OCS. Teva acknowledges that the Cell Cure IP is subject to the Encouragement of Industrial Research and Development Law- 1984 (the "Law"), so that certain portions of the Cell Cure IP may not be transferred to a foreign person or entity without the prior consent of the OCS, which Teva undertakes to obtain, should it so require, at its sole expense;
 
 
9.3.2.
In carrying out its undertakings and responsibilities pursuant to this Agreement, Teva shall comply, and shall require that is Affiliates, Sublicensees and Further Sublicensees comply with all applicable laws and regulations, standards and guidelines, including applicable local and international ethical guidelines (such as the ISSCR guidelines and the American Academy of Science guidelines, to the extent applicable), licenses, permits, approvals and procedures, including, without limitation, the Law, including in the use of the Licensed Materials and in respect of any transfer thereof by or from Teva and in the performance of Teva's obligations in the development, production, use and sale of Licensed Product; and

 
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9.3.3.
Teva shall be responsible for obtaining and causing to remain in effect, and shall comply with such licenses, permits, approvals, and consents, including any MOH Ethics Committee approvals, as may be required for performance by Teva and/or Further Sublicensees of this Agreement, including, the development, manufacture, use and sale of Licensed Product.
 
 
9.4.
Without derogating from any of the remedies available to either Party hereunder or under applicable law, if either Party shall become aware of the inaccuracy of any of the above representations and warranties, such Party shall immediately notify the other Party of such in writing.
 
 
9.5.
Except as otherwise expressly provided in this Agreement, no Party makes any warranty with respect to any technology, patents, goods, services, rights or other subject matter of this Agreement and each Party hereby disclaims warranties of merchantability and fitness for a particular purpose with respect to any and all of the foregoing. Without derogating from the generality of the foregoing, nothing contained in this Agreement is a warranty or representation by any Party that any efforts to be exerted by such Party in connection with this Agreement including without limitation any development activities to be performed by them under this Agreement will achieve their aims or succeed, and the Parties make no warranties whatsoever as to any results to be achieved in consequence of the carrying out of any such efforts or activities; and that any Patents will be issued,  valid or afford proper protection or that the Cell Cure IP will be commercially exploitable or of any other value.
 
10.
Term and Termination
 
 
10.1.
This Agreement shall continue in full force and effect until terminated in accordance with the terms hereof.
 
 
10.2.
This Agreement shall automatically terminate upon the earlier of (i) expiration of the Option Period if Teva does not exercise the License Option within such Option Period; and (ii) Teva failing to provide funding as required for the continuation of the R&D Program over and above Cell Cure’s Participation pursuant to Section 2.1.7 above. For the avoidance of doubt, upon the termination of this Agreement pursuant to this Section 10.2, Teva shall have no rights in any Cell Cure IP and any information sublicensed to Teva hereinunder and Teva shall promptly transfer to Cell Cure, upon its written request, all related documents, instruments, records and data generated, developed or disclosed to it during the term of this Agreement and the R&D Program, in its possession, and shall be allowed to retain one copy for archival purposes.

 
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10.3.
At any time, Teva shall have the right at its sole discretion to terminate this Agreement for any or for no reason, by providing Cell Cure with thirty (30) days’ written notice of such decision.  In this event Teva shall not be obliged to pay any compensation to Cell Cure as a result of such termination.
 
 
10.4.
Without derogating from any other remedies that either Party may have under the terms of this Agreement or at law, each Party shall have the right to terminate this Agreement upon the occurrence of any of the following:
 
 
10.4.1.
the other Party commits a material breach of this Agreement and fails to remedy that breach within forty-five (45) days after being requested to do so by the non-breaching Party; or
 
 
10.4.2.
upon the filing or institution of bankruptcy, reorganization, liquidation or receivership proceedings, or upon an assignment of a substantial portion of the assets for the benefit of creditors by the other Party; provided, however, in the case of any involuntary bankruptcy, reorganization, liquidation, receivership or assignment proceeding such right to terminate shall only become effective if such other Party consents to the involuntary proceeding or such proceeding is not dismissed within ninety (90) days after the filing thereof.
 
 
10.5.
Without derogating from and subject to Teva’s obligations pursuant to Section 10.6 below, upon the termination of this Agreement by Teva for any reason whatsoever after Teva has exercised the License Option:
 
 
10.5.1.
the License granted to Teva by Cell Cure shall be terminated;
 
 
10.5.2.
Teva, its Sublicensees and Further Sublicensees shall cease all use of the Cell Cure IP and Licensed Product including the commercialization of Licensed Product;
 
 
10.5.3.
Each Party, at the written request of the other Party, shall immediately return to the other Party all materials, reports, updates, documentation, written instructions, notes, memoranda, discs or records or other documentation or physical matter of whatsoever nature or description provided by the other Party, except in the event that such material is owned by such Party pursuant to the terms of this Agreement, and provided that each Party shall be allowed to retain one copy for archival purposes;
 
 
10.5.4.
At the request of either Party, the other Party shall execute and deliver such assignments and licenses and other documents as may be necessary to fully vest in the requesting Party all right, title and interest to which it is entitled pursuant to this Section 10; and

 
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10.5.5.
Each Party shall be entitled to collect any debt then owed to it by the other Party.
 
 
10.6.
In addition to the provisions set forth in Section 10.5 above, upon the termination of this Agreement by Teva pursuant to Section 10.3 above or by Cell Cure pursuant to Section 10.4 above, after Teva has exercised the License Option:
 
 
10.6.1.
Teva shall promptly transfer to Cell Cure, upon Cell Cure’s written request, all documents, instruments, records and data relevant to the development or commercialization of Licensed Product generated, developed or disclosed to it during the term of this Agreement, including, but not limited to, all documentation and information related to the Teva IP, in its possession, that are solely and directly related to Licensed Product, and shall be allowed to retain one copy for archival purposes;
 
 
10.6.2.
Teva shall provide Cell Cure with a report summarizing its development activities and the results up to termination;
 
 
10.6.3.
Teva shall be deemed without any further action to have granted to Cell Cure a non-exclusive, worldwide license (including the right to grant sublicenses), under Teva’s interest in any Teva IP that is solely and directly related to Licensed Product, to develop, have developed, make, have made, use, have used, offer for sale, sell, have sold, import and have imported Licensed Product; and
 
 
10.6.4.
Teva shall transfer and assign to Cell Cure all existing marketing applications, registrations, marketing approvals, pricing approvals and similar rights with respect to Licensed Product.
 
 
10.7.
Save as otherwise provided in this Agreement, any provision that by its nature is intended to survive termination or expiry shall survive the termination or expiry of this Agreement.
 
11.
Indemnification
 
 
11.1.
Teva shall indemnify, defend, and hold harmless Cell Cure, ESI, Hadasit,  HMO and the directors, officers, employees, and agents of any of the foregoing and their respective successors, heirs and assigns (the “Cell Cure Indemnitees”), from and against any liability, damage, loss, or expense (including reasonable attorney’s fees and expenses) incurred by or imposed upon any of the Cell Cure Indemnitees in connection with any claims, suits, actions, demands or judgments of third parties (“Claims”) arising out of or resulting from (i) a breach of a representation or warranty of Teva under this Agreement; (ii) any Claim  that the practice of the License or the development, manufacture, use, sale or other disposition of Licensed Product infringes or violates any IP rights of such third party,  (iii)  the exercise of the License and/or use or exploitation of the Cell Cure IP or Licensed Product by Teva, or any of its Affiliates, Sublicensees, Further Sublicensees, subcontractors or distributors of Teva or its Affiliates, Sublicensees or Further Sublicensees ; (iv) any death, illness, injury or adverse event arising or allegedly arising from or in connection with the use of  Licensed Product manufactured, produced, packaged, sold, delivered, provided (including but not limited to Licensed Product provided in clinical trials or provided without compensation or charge) or distributed, directly or indirectly by Teva, or any of its Affiliates, Sublicensees, Further Sublicensees, or by any subcontractors or distributors of Teva, or its Affiliates, Sublicensees or Further Sublicensees, except in cases where, and to the extent that, such Claims result from the breach of this Agreement or the ESI License Agreement or the Hadasit License Agreement,  negligence or willful misconduct, by or on the part of any of the Cell Cure Indemnitees and/or any misrepresentation by the any of the Cell Cure Indemnitees under any such agreements.

 
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11.2.
Teva’s undertakings under Section 11.1 above shall be subject to: (a) receipt of prompt written notice of any Claim by the Cell Cure Indemnitee (provided, however, that the failure to give such notice shall not affect Teva’s indemnification undertakings provided hereunder except to the extent that any material substantive or procedural right of Teva shall have been actually materially  prejudiced as a result of such failure), (b) the cooperation of the Cell Cure Indemnitee(s) regarding the response to and the defense of any such Claim, and (c) Teva’s right, by written notice to the Cell Cure Indemnitees, to assume the defense of the Claim or represent the interests of the Cell Cure Indemnitees with respect to such Claim, that shall include the right to select and direct legal counsel and other consultants to appear in proceedings on behalf of the Cell Cure Indemnitees and to propose, accept or reject offers of settlement, all at its sole cost; provided however, that no such settlement shall be made without the written consent of the Cell Cure Indemnitees, such consent not to be unreasonably withheld or delayed.  Nothing herein shall prevent the Cell Cure Indemnitees from retaining their own counsel and participating in their own defense at their own cost and expense. If the Cell Cure Indemnities shall determine that a conflict of interest arose between Teva and the Cell Cure Indemnities and the attorney is unable to continue to represent Teva together with the Cell Cure Indemnities, the Cell Cure Indemnities shall provide Teva with written detailed reasons for such determination, and following receipt of such reasons then senior representatives of the Parties shall meet to resolve such conflict, but, if after 7 days such senior representatives are unable to resolve such conflict, then the Cell Cure Indemnities shall be entitled, at Teva's expense, to appoint their own counsel (to be prior agreed by Teva, such agreement not to be unreasonably withheld or delayed) to represent them in such litigation and the Teva counsel shall fully inform such counsel and provide all necessary material.
 
 
11.3.
Cell Cure shall indemnify, defend, and hold harmless each of Teva and its directors, officers, employees, and agents and its respective successors, heirs and assigns (the “Teva Indemnitees”), from and against any liability, damage, loss, or expense (including reasonable attorney’s fees and expenses) incurred by or imposed upon any of the Teva Indemnitees in connection with any Claims arising pursuant to a breach of a representation or warranty of any of the Cell Cure Indemnitees under this Agreement or the ESI License Agreement or the Hadasit License Agreement and/or concerning negligent acts or omissions to act by Cell Cure Indemnitees or their subcontractors in the activities of Cell Cure under this Agreement or ESI under the ESI License Agreement or Hadasit and/or HMO under the Hadasit License Agreement, except in cases where, and to the extent that, such Claims result from the breach of this Agreement, negligence or willful misconduct by or on the part of any of the Teva Indemnitees and/or any misrepresentation by Teva under this Agreement.

 
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11.4.
Cell Cure’s undertakings under Section 11.3 above shall be subject to: (a) receipt of prompt written notice of any Claim by the Teva Indemnitee (provided, however, that the failure to give such notice shall not affect their indemnification undertakings provided hereunder except to the extent that any material substantive or procedural right of Cell Cure shall have been actually materially prejudiced as a result of such failure), (b) the cooperation of the Teva Indemnitee(s) regarding the response to and the defense of any such Claim, and (c)  Cell Cure’s right, by written notice to the Teva Indemnitees, to assume the defense of the Claim or represent the interests of the Teva Indemnitees with respect to such Claim, that shall include the right to select and direct legal counsel and other consultants to appear in proceedings on behalf of the Teva Indemnitees and to propose, accept or reject offers of settlement, all at its sole cost; provided however, that (a) the legal counsel and consultants selected by Cell Cure to represent the Teva Indemnitees shall be different from Cell Cure’s legal counsel and consultants, if any defenses available to any Teva Indemnitees conflict with or are different from those available to Cell Cure, or if any other conflict of interest would result from such legal counsel or consultants representing both Cell Cure and any Teva Indemnitees, and (b)  no such settlement shall be made without the written consent of the Teva Indemnitees, such consent not to be unreasonably withheld or delayed.  Nothing herein shall prevent the Teva Indemnitees from retaining their own counsel and participating in their own defense at their own cost and expense. If the Teva Indemnities shall determine that a conflict of interest arose between Cell Cure and the Teva Cure Indemnities and the attorney is unable to continue to represent Cell Cure together with the Teva Indemnities, the Teva Indemnities shall provide Cell Cure with written detailed reasons for such determination, and following receipt of such reasons then senior representatives of the Parties shall meet to resolve such conflict, but, if after 7 days such senior representatives are unable to resolve such conflict, then the Teva Indemnities shall be entitled, at Cell Cure's expense, to appoint their own counsel (to be prior agreed by Cell Cure, such agreement not to be unreasonably withheld or delayed) to represent them in such litigation and the Cell Cure counsel shall fully inform such counsel and provide all necessary material.
 
12.
Insurance
 
 
12.1.
Each Party shall maintain, for the term of this Agreement and thereafter, insurance sufficient to cover its obligations under this Agreement and under law as it customarily maintains for similar activities in the regular course of its business. Teva may fulfill its obligation under this Section 12 to obtain insurance by the maintenance of appropriate self insurance regardless of the nature or title thereof.

 
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12.2.
During the term of this Agreement, Cell Cure shall maintain, at its cost, insurance against legal liability and other risks associated with its activities and obligations under this Agreement, in such amounts which in any case shall not be less than [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission], subject to such deductibles and on such terms as are customary for a company such as Cell Cure for the activities to be conducted by it under this Agreement. Cell Cure shall furnish Teva with evidence of such insurance upon Teva’s request.
 
13.
Limitation of Liability
 
EXCEPT IN THE CASE OF A WILLFUL OR FRAUDULENT MISREPRESENTATION UNDER THIS AGREEMENT, IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER OR ANY OF ITS AFFILIATES FOR ANY CONSEQUENTIAL, INCIDENTAL, INDIRECT, SPECIAL, PUNITIVE OR EXEMPLARY DAMAGES (INCLUDING, WITHOUT LIMITATION, LOST PROFITS, BUSINESS OR GOODWILL) SUFFERED OR INCURRED BY SUCH OTHER PARTY OR ITS AFFILIATES, WHETHER BASED UPON A CLAIM OR ACTION OF CONTRACT, WARRANTY, NEGLIGENCE OR TORT, OR OTHERWISE, ARISING OUT OF THIS AGREEMENT.
 
14.
Confidentiality
 
 
14.1.
Other than as expressly set forth herein, Teva and Cell Cure undertake to treat and to maintain and to ensure that their Representatives (as defined below) shall treat and maintain, in strict confidence and secrecy any information disclosed by either Party under this Agreement, whether before of following the Effective Date, whether disclosed in oral or visual form or in writing and shall keep in confidence the existence and contents of this Agreement (the “Confidential Information”) and shall not disclose, publish, or disseminate in any manner, any Confidential Information including, without limitation, any aspect  thereof, to a third party other than those of its Representatives with a need to know the same for the purpose of performing its obligations under this Agreement (the “Purpose”).  In addition, each Party agrees to treat and maintain (and to ensure that its Representatives treat and maintain) in strict confidence and secrecy and to prevent any unauthorized use, disclosure, publication, or dissemination of the Confidential Information, except for the Purpose.  Each Party agrees to be responsible for any use or disclosure of Confidential Information of any of its Representatives.
 
 
14.2.
Each Party shall:
 
 
14.2.1.
safeguard and keep secret all Confidential Information, and will not directly or indirectly disclose to any third party the Confidential Information without written permission of the other.

 
29

 
 
 
14.2.2.
in performing its duties and obligations hereunder, use at least the same degree of care as it does with respect to its own confidential information of like importance but, in any event, at least reasonable care.
 
 
14.3.
The undertakings and obligations under Sections 14.1 and 14.2 shall not apply to any part of the Confidential Information which:
 
 
14.3.1.
was known to the recipient of the Confidential Information (the “Recipient”) prior to disclosure by the disclosing Party (the “Discloser”);
 
 
14.3.2.
was generally available to the public prior to disclosure to the Recipient;
 
 
14.3.3.
is disclosed to the Recipient by a third party who is not bound by any confidentiality obligation, having a legal right to make such disclosure;
 
 
14.3.4.
has become through no act or failure to act on the part of the Recipient public information or generally available to the public;
 
 
14.3.5.
was independently developed by the Recipient without reference to or reliance upon the Confidential Information;
 
 
14.3.6.
is required to be disclosed by the Recipient or any Affiliate of the Recipient by law, by court order, or governmental regulation (including securities laws and/or exchange regulations), provided that the Recipient or its Affiliate gives the Discloser reasonable notice prior to any such disclosure and cooperates (at the Discloser’s expense) with the Discloser to assist the Discloser in obtaining a protective order or other suitable protection from disclosure (if available) with respect to such Confidential Information.
 
Notwithstanding the foregoing, in the event that either Party is required to disclose Confidential Information pursuant to securities laws or the rules or regulations of any securities exchange, then the provisions of Section 15.1 below shall apply.
 
 
14.4.
Teva and Cell Cure acknowledge that their respective Confidential Information is of special and unique significance to each of them and that any unauthorized disclosure or use of the Confidential Information could cause irreparable harm and significant injury to the Discloser that may be difficult to ascertain. Accordingly, any breach of this Agreement may entitle the aggrieved Party in addition to any other right or remedy that it may have available to it by law or in equity, to remedies of injunction, performance and other relief, including recourse in a court of law.

 
30

 
 
 
14.5.
Each Party agrees to inform the other Party of any breach or threatened breach of the provisions hereof by its Representatives (as defined below).
 
 
14.6.
Notwithstanding the foregoing, Cell Cure shall be permitted to provide copies of reports furnished to it by Teva pursuant to Section 6.1, Development Reports and other information disclosed to it hereunder to Cell Cure’s Affiliates subject to confidentiality provisions no less stringent than those contained herein, and to ESI and Hadasit to the extent required for Cell Cure to meet its obligations pursuant to the ESI License Agreement and the Hadasit License Agreement and subject to the confidentiality provisions thereunder.
 
 
14.7.
Moreover, each Party may disclose the terms of this Agreement to the extent required, in the reasonable opinion of such Party’s legal counsel, to comply with applicable laws, as well as to prospective and current financial investors pursuant to appropriate non-disclosure arrangements, provided however that prior to any disclosure, the disclosing Party shall consult with the non-disclosing Party, and the non-disclosing Party shall have the right to delete business sensitive information. In the event of a potential investor or sublicensee who is a big pharmaceutical company or the investment arm of a big pharmaceutical company, Cell Cure may disclose only a redacted version of this Agreement, in a form approved by Teva in advance. Notwithstanding the foregoing, it is understood and agreed that Cell Cure shall be entitled to provide a copy of this Agreement, as well information furnished to it hereunder, to its current licensors, in order and only to the extent required to fulfill its contractual obligations towards them.
 
 
14.8.
The provisions relating to confidentiality in this Section 14 shall remain in effect during the term of this Agreement and for a period of seven (7) years after its termination.
 
 
14.9.
For the purposes of this Section 14 “Representatives” shall mean employees, officers, agents, subcontractors, consultants, and/or any other person or entity acting on either Party’s behalf, individually or collectively and which shall be exposed to Confidential Information. For the avoidance of doubt, with respect to Teva, the Teva Representative shall be deemed a Representative for the purposes of the foregoing definition.
 
15.
Publication
 
 
15.1.
[*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission]
 
 
15.2.
[*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission]
 
 
15.3.
[*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission]

 
31

 
 
16.
Independent Contractors
 
 
16.1.
It is expressly agreed that the Parties shall be independent contractors and that the relationship between the Parties shall not constitute a partnership, joint venture or agency. Neither Party shall have the authority to make any statements, representations or commitments of any kind, or to take any action, which shall be binding on the other Party, without the prior consent of such other Party.
 
 
16.2.
Cell Cure agrees that its employees, officers, agents, subcontractors, consultants, and/or any other person or entity acting on Cell Cure’s behalf, individually or collectively, shall be the sole responsibility of Cell Cure and shall not be considered at any time as Teva employees and shall not have any claims against Teva whatsoever.
 
17.
General Payment and Tax Provisions
 
 
17.1.
All amounts required to be paid pursuant to this Agreement are final and inclusive of all taxes and/or duties, of whatsoever nature, except for VAT which will be added, where applicable, to all payments to be made by Teva to Cell Cure against the appropriate tax invoices.
 
 
17.2.
If applicable laws require that taxes be withheld from any amounts due to Cell Cure under this Agreement, Teva shall (a) deduct these taxes from the remittable amount, (b) pay the taxes to the proper taxing authority, and (c) deliver to Cell Cure a statement including the amount of tax withheld and justification therefore, and such other information as may be necessary for tax credit purposes.  For the avoidance of doubt, any amounts due to Cell Cure under this Agreement shall be reduced by any withholding or similar taxes applicable to such payment, such that the actual maximum payment by Teva shall not exceed the amounts or the rates provided in this Agreement.
 
 
17.3.
All payments to be made hereunder shall be made by the due date for payment as provided herein, in US Dollars or in New Israeli Shekels, as converted from US Dollars as per the conversion rate existing in the US (as reported in the Wall Street Journal) last published prior to the actual date of payment.
 
 
17.1.
Teva shall be entitled to set-off from any amounts due to Cell Cure under this  Agreement, amounts not exceeding the amounts of any damage caused to Teva as a result of Cell Cure’s breach under this Agreement. For the avoidance of doubt, should Teva duly exercise the step-in rights extended to it by ESI and/or Hadasit under the side letters attached hereto as Annex E and Annex F, then should Teva choose not to terminate this Agreement, Teva shall have the right to set-off any amounts paid by Teva to ESI and/or Hadasit under any license(s) granted to it pursuant to such side letters, from any amount that may be due from Teva to Cell Cure hereunder.

 
32

 
 
18.
Assignment and Subcontracting
 
 
18.1.
Teva is permitted to assign its rights and obligations under this Agreement to its Affiliates either with respect to the entire Agreement or with respect to the rights and obligations related to any part of this Agreement and shall further be entitled to perform any and all of its rights hereunder either directly or through its Affiliates or subcontractors, provided that Teva shall remain liable to Cell Cure for the performance of all its obligations under this Agreement notwithstanding any such assignment.
 
 
18.2.
Cell Cure shall not, without the prior written consent of Teva, assign, charge or mortgage in any other manner all or any of its rights or obligations under this Agreement, except that Cell Cure may assign, pledge, mortgage, grant a security interest in, or otherwise encumber its rights to payments from Teva. Any assignment not in accordance with this Agreement shall be null and void. Notwithstanding the foregoing, Cell Cure may assign its rights and its obligations hereunder to any entity that acquires all or substantially all of its business and/or assets which are the subject of this Agreement, provided that such entity shall first undertake to Teva in writing to meet all undertakings and obligations of Cell Cure hereunder, and shall execute this Agreement and become a party hereto as if same had been the original signatory to this Agreement from the Effective Date hereof in place of Cell Cure.
 
19.
Amendments
 
No amendment of this Agreement shall be valid unless it is in writing and signed by, or on behalf of, each of the Parties.
 
20.
Severance
 
Should any part or provision of this Agreement be held unenforceable or in conflict with the applicable laws or regulations of any applicable jurisdiction, the invalid or unenforceable part or provision shall, provided that it does not go the essence of this Agreement, be replaced with a revision which accomplishes, to the extent possible, the original commercial purpose of such part or provision in a valid and enforceable manner, and the balance of this Agreement shall remain in full force and effect and binding upon the Parties.
 
21.
Entire Agreement
 
This Agreement and its annexes constitute the entire agreement between the Parties with respect to its subject matter and supersede all prior agreements, arrangements, dealings or writings between the Parties.

 
33

 
 
22.
Waiver
 
No waiver of a breach or default hereunder shall be considered valid unless in writing and signed by the Party giving such waiver and no such waiver shall be deemed a waiver of any subsequent breach or default of the same or similar nature.
 
23.
Further Assurances
 
Each Party agrees to execute, acknowledge and deliver such further documents and instruments and do any other acts, from time to time, as may be reasonably necessary, to effectuate the purposes of this Agreement.
 
24.
Third Parties

None of the provisions of this Agreement shall be enforceable by any person who is not a party to this Agreement. Notwithstanding the foregoing, the Cell Cure Indemnitees shall be treated as third party beneficiaries of this Agreement with full authority to enforce the terms of Section 11 hereof.
 
25.
Notices
 
Any notice, declaration or other communication required or authorized to be given by any Party under this Agreement to the other Party shall be in writing and shall be personally delivered, sent by facsimile transmission (with a copy by ordinary mail in either case) or dispatched by courier addressed to the other Party at the address stated below or such other address as shall be specified by the Parties by notice in accordance with the provisions of this Section 25.  Any notice shall operate and be deemed to have been served, if personally delivered, sent by fax or by courier on the next following business day.
 
Teva’s and Cell Cure’s addresses for the purposes of this Agreement shall be as follows:
 
If to Teva:
 
Teva Pharmaceutical Industries Ltd.
Innovative Ventures
Attention: Dr. Aharon Schwartz
16 Basel Street, Petah Tiqva 49131, Israel
 
Telephone:
972-3-9267277
 
Facsimile:
972-3-9267581
 
With a copy (that will not constitute notice) to:
Teva Pharmaceutical Industries Ltd.
Attention: General Counsel, Legal Department
5 Basel Street, Petah Tiqva 49131, Israel
 
Telephone:
972-3-926-7297
 
Facsimile:
972-3-926-7429

 
34

 
 
If to Cell Cure:
 
Cell Cure Neurosciences Ltd.
Kiryat Hadassah, PO Box 12247
Jerusalem 91121, Israel
Facsimile: + 972 2 642 9856
Attention: The Managing Director
 
With a copy (which will not constitute notice):
 
Baratz & Co.
Attorneys-at-Law & Notaries
1 Azrieli Center, Round Tower, 18th Floor
Tel Aviv 67021
Israel
Attention: Adv. Yael Baratz
Facsimile: +972 3 6960986
 
26.
Governing Law and Jurisdiction
 
This Agreement shall be governed by the laws of the state of Israel.  All actions, suits or proceedings arising out of or relating to this Agreement shall be heard and determined in a court sitting in Courts of Tel Aviv-Jaffa, Israel, and the Parties hereby irrevocably submit to the exclusive jurisdiction of such courts in any such action or proceeding and irrevocably waive any defense of an inconvenient forum to the maintenance of any such action or proceeding.
 
27.
Force Majeure
 
 
27.1.
If either Party is prevented from fulfilling its obligations under this Agreement by reason of any supervening event beyond its control (including but not limited to war, national emergency, flood, earthquake, strike or lockout the party unable to fulfill its obligations (the "Incapacitated Party") it shall immediately give notice of this to the other Party and shall do everything reasonably within its power to resume full performance of its obligations as soon as possible.
 
 
27.2.
Subject to compliance with the requirements of Section 27.1 the Incapacitated Party shall not be deemed to be in breach of its obligations under this Agreement during the period of incapacity in the circumstances referred to in Section 27.1 and the other Party shall continue to perform its obligations under this Agreement save only in so far as they are dependent on the prior performance by the Incapacitated Party of obligations which it cannot perform during the period of incapacity.

 
35

 
 
28.
Interpretation
 
The Parties have each had the opportunity to have this Agreement reviewed by an attorney; therefore, neither this Agreement nor any provision hereof shall be construed against the drafter of this Agreement.
 
29.
Counterparts
 
This Agreement may be executed in any number of counterparts (including counterparts transmitted by fax or by electronic mail in PDF format), each of which shall be deemed to be an original, but all of which taken together shall be deemed to constitute one and the same instrument.
 

 
[Intentionally left blank]

 
36

 

Signature page
 
Research and Exclusive Option Agreement
 
IN WITNESS WHEREOF, each Party has caused this Agreement to be executed by its duly authorized representatives:

 
TEVA PHARMACEUTICAL INDUSTRIES LIMITED
   
CELL CURE NEUROSCIENCE LTD.
 
 
signature:
   
signature:
 
           
           
 
name:
   
name:
 
           
           
 
designation:
   
designation:
 
           
           
 
signature:
   
signature:
 
           
           
 
name:
   
name:
 
           
           
 
designation:
   
designation:
 
           
           
 
Date:  ___________________  2010
   
Date:  _____________________  2010
 
           

 
37

 

List of Annexes:

Annex A
ESI License Agreement
Annex B
Hadasit License Agreement
Annex C
Patents
Annex D
R&D Program
Annex E
Step-in Letter – ESI
Annex F
Step-in Letter – Hadasit
Annex G
Form of MTA
Annex H
Press Release
Annex I
Approval of HMO Ethics Committee
 
 
38

 
 
CELL CURE NEUROSCIENCES LTD.

AND

ES CELL INTERNATIONAL PTE LTD

___________________________

EXCLUSIVE LICENSE AGREEMENT
___________________________

 
 

 
 
Execution Copy
 
THIS EXCLUSIVE LICENSE AGREEMENT
is made effective on this 22 day of March 2006

BETWEEN:

CELL CURE NEUROSCIENCES LTD. a company incorporated under the laws of Israel, c/o Hadasit Medical Research Services and Development Ltd,, Kiryat Hadassah, PO Box 12000, Jerusalem 91120, Israel ("CELLCURE")

AND

ES CELL INTERNATIONAL PTE LTD, a company incorporated under the laws of Singapore, #05-06 Helios, 11 Biopolis Way, Singapore 138667 ("ESI")


 
RECITALS

I.
ESI is engaged in the development and commercialization of cell therapy applications based on cells derived from human embryonic stem cells, and is the owner of the Patent Rights and Technology.,

II.
CELLCURE has been established to undertake the development and commercialization of cell therapy applications for neurodegenerative diseases, based on cells derived from human embryonic stem cells, with its first target disease being Parkinson's disease.

III.
ESI wishes to enter into a commercial arrangement for the exploitation of the Patent Rights and Technology in the Field. ESI has chosen CELLCURE to be the vehicle for the same.

IV.
In recognition of the value of the right to exploit the same, HBL- Hadasit Bio-Holdings Ltd, of Kiryat Hadassah Jerusalem, Israel ("HBL") has agreed to inject or procure funds for injection into CELLCURE,,

V.
HBL and ESI have, under the terms of the Subscription Agreement, agreed to subscribe for shares in CELLCURE,, Under the terms of the Subscription Agreement, ESI will grant a license to CELLCURE on the terms herein.

VI.
Under the terms of the Subscription Agreement, HBL shall endeavor to procure financing for CELLCURE in two tranches, subject to and in consideration for which the "HBL 1st Issue Shares" and "HBL 2nd Issue Shares" as defined in the Subscription Agreement may belong to HBL. In view of the terms and conditions in connection with the HBL 1st Issue Shares and the HBL 2nd Issue shares and other terms and conditions of the Agreement, each of the grant and scope of the License will be subject to the fulfillment of certain conditions, the terms of which are set out herein.

VII.
In the event that certain conditions are not achieved within the allotted time, the Agreement will be terminated on the terms herein.

IT IS AGREED as follows.

 
 

 
 
Exclusive License Agreement - Execution Copy
 
 
1. 
DEFINITIONS AND INTERPRETATION

1.1 
Definitions

The following definitions apply unless the context requires otherwise:

Affiliate with respect to a corporation, means a corporation which owns or controls, is owned or controlled by or is under common ownership with or control of the first-named corporation. For the purposes of this definition, the term "owns" as used with respect to any person means ownership (directly  or  indirectly)  of  at least fifty-one per cent (51%) of the outstanding voting securities of a corporation or a comparable  equity interest in a corporation (or such lesser percentage, being the maximum percentage of ownership allowed by law in a particular jurisdiction).

Agreement means this Exclusive Licence Agreement

Condition Subsequent  means,  upon  HBL's  failure  to meet  the HBL Objective within the HBL  Objective Period, the condition that, HBL achieves  at least  One Million US Dollars (USD 1,000,000) out of the HBL Objective within thirty six (36) months of the Completion Date.

Confidential Information means the confidential subject matter of Technology and (where still confidential) in connection with the Patent Rights together with any Intellectual Property Rights therein, business and financial information and other commercially valuable information in whatever form and of whatever description including   without   limitation   unpatented   inventions,   trade   secrets,   know-how, concepts, formulae, discoveries, improvements of or in the possession of the disclosing Party but excluding information which:

 
(a)
is or becomes published or otherwise part of the public domain other than by breach of the terms of this Agreement or breach of any confidentiality obligations owed to the disclosing party by any third party;

 
(b)
is  disclosed  to  the  receiving  Party  by  a  third  party,  provided  such information was not obtained by such third party directly or indirectly from the disclosing Party (as the case may be) or breach of any confidentiality obligations owed to the disclosing party by any third party;

 
(c)
prior to  disclosure  pursuant  to  this  Agreement,  was  already  in  the possession of the receiving Party, provided such information was not obtained directly or indirectly from the disclosing Party;

 
(d)
is required by law or the rules of any relevant stock or securities exchange to be disclosed.

Completion (and, correspondingly, Completion Date) has the same meaning as in the Subscription Agreement.

 
-3-

 
 
Exclusive License Agreement - Execution Copy
 
 
ESI Subscription Shares has the same meaning as in the Subscription Agreement.

Exploit means to develop, manufacture, have manufactured, import, export, use, sell market, distribute and offer for sale and/or license a third party to do so and Exploitation will be similarly construed.,

Field means the development of and exploitation of hES derived neural cells solely for cell replacement therapy of neurodegenerative diseases in a human. And correspondingly, Restricted Field means, a sub-set of the Field, being the restricted field of development of and exploitation of hES derived neural cells solely for cell replacement therapy of Parkinson's disease in a human,.

Hadasit means Hadasit Medical Research Services and Development Ltd,

HBL means HBL - Hadasit Bio-Holdings Ltd.,

HBL 1st Issue Shares has the same meaning as in the Subscription Agreement,

HBL 2nd Issue Shares has the same meaning as in the Subscription Agreement.

HBL Objective has the same meaning as in the Subscription Agreement,

HBL Objective Period means the period of twenty four (24) months from the Completion Date.

Improvement means any invention (whether patentable or not) which is a derivative of the Patent Rights or Technology that is developed by, or in collaboration with, or on behalf of, CELLCURE.

Intellectual Property Rights means the statutory and other rights in respect of patents, utility models, designs, circuit layouts, mask rights, copyrights, confidential information, trade secrets, know-how, trade marks and all other rights in respect of intellectual and industrial property.

License means the grant of the rights and licenses granted to CELLCURE for use of the Technology and Patent Rights in the Field in Clause 2.1 of this Agreement. And correspondingly, Restricted License means, the grant of the rights and licenses granted to CELLCURE for use of the Technology arid Patent Rights in the Restricted Field arising in accordance with the terms of this Agreement The grants of the License and the Restricted License are set out in Clause 2 of this Agreement.

Licensed Product means a cellular product derived from the differentiation of human embryonic stem cells, the manufacture, import, use, sale or offer for sale of which falls within the scope of one or more subsisting and unexpired claims within the Patent Rights which has not been permanently revoked, held unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction, unappealable or unappealed within the time allowed for appeal, and which has not been admitted to be invalid or unenforceable through reissue or disclaimer or otherwise.

 
-4-

 
 
Exclusive License Agreement - Execution Copy


Milestones means the milestones described in Schedule 2.

Outfield Improvements means such Improvements as may have either (i) general applicability to ail fields within and outside of the Field or Restricted Field (as the case may be) or (ii) applicability only to fields outside of the Field or Restricted Field (as the case may be).

Parties means the parties to this Agreement and Party means any one of them.

Patent Rights means the patents and patent applications listed in Schedule 1 including:

 
(i)
corresponding applications and patents claiming priority from any one or more of those patents and patent applications filed in any country in the world;

 
(ii)
patents and any special protection certificates that issue on the applications listed in the Schedule or the patents and applications referred to in paragraph (I) above;

 
(iii)
divisions, continuations, continuations-in-part, reissues, re-examinations, registrations, divisional and substituted patents from the patents and patent applications listed in the Schedule or the patents and applications referred to in paragraph (i) above; and

 
(iv)
supplementary protection certificates or extensions to any of such patents or patent applications.

Progenitor Cells means ESI's HE cell lines as listed on the NIH stem cell registry.

Researchers means Monash University, National University of Singapore and Hadasit.

Registration Costs means in respect of the 2 patent applications listed in Schedule 1 as 1 and 3 and to their corresponding applications and any patents that issue thereon, all of the out-of-pocket fees, costs and expenses (including without limitation patent attorney and legal fees and expenses) incurred in the filing, prosecuting, registering and maintaining the Patent Rights after the Completion and includes without limitation all expenses incurred in making any amendment and in relation to any oppositions relating to such Patent Rights. In respect of the patent application listed in Schedule 1 as 2, its corresponding applications and any patents that issue thereon, as well as any future patent applications or patents that fail within the definition of Patent Rights, the following shall be taken into account as Registration Costs for purposes of this Agreement:

 
(a)
all of such fees, costs and expenses insofar as they relate solely to claims within the Field;

 
(b)
50% of such fees, costs and expense insofar as they relate to claims that have applicability both within and out of the Field.

 
-5-

 
 
Exclusive License Agreement - Execution Copy


Royalties means the royalties which form part of the consideration of the grant of the License (or Restricted License as the case may be), referred to in Clause 3.1 of this Agreement,

Shareholders Agreement means the Shareholders Agreement referred to and defined as such in the Subscription Agreement, duly executed by the relevant parties thereto, which comes into effect as such date as pursuant to the provisions of the Subscription Agreement;

Sub-License means a license where CELLCURE grants any sub-licence to a third party of any Patent Rights (whether combined or not with Improvements) and Intellectual Property Rights in the Technology (whether combined or not with Improvements).

Sub-License Revenue means all consideration, whether monetary or otherwise, received by CELLCURE arising from any Sub-License granted under the terms of this Agreement.

Subscription Agreement means the Subscription Agreement executed between ESI, CELLCURE and HBL dated November 20, 2005,

Subsequent Objective means, following HBL's achievement of the HBL Objective within the HBL Objective Period, a further objective to be attained by HBL and/or its sub-licensee, to earmark at least USD 1,000,000 towards research in the "Non-Parkinson's Field" (as defined in the Shareholder's Agreement at clause 3.4 within a further twelve (12) months following the expiration of the HBL Objective Period, Details of the Subsequent Objective are set out in the clause 3.4 of the Shareholder's Agreement.

Technology means any technology and know-how (whether patentable or not) having application within the Field including without limitation any of the inventions described or claimed in the Patent Rights with regard to human embryonic stem cells, in the possession of ESI, as at the Completion Date. A general description of the Technology currently in the possession of ESI is attached as Schedule 3 hereto. An updated Schedule 3, containing a general description of the Technology in the possession of ESI as at the Completion Date, shall be attached to this Agreement upon the Completion Date.

Term means the term of this Agreement determined in accordance with Clause 10,

Territory means the entire world.

1.2
Interpretation

Headings are for convenience only and do not affect interpretation. The following rules apply unless the context requires otherwise.

 
(i)
The singular includes the plural and conversely plural includes the singular,

 
(ii)
A reference to gender includes all genders,

 
-6-

 
 
Exclusive License Agreement - Execution Copy


 
(iii)
If a word or phrase is defined, its other grammatical forms have a corresponding meaning.

 
(iv)
A reference to a person, corporation, trust, partnership, unincorporated body or other entity includes any of them.

 
(v)
A reference to a Clause or Schedule is a reference to a clause of or a schedule to this Agreement.

 
(vi)
A reference to an agreement or document (including, without limitation, a reference to this Agreement) is to the agreement or document as amended, varied, supplemented, novated or replaced, except to the extent prohibited by this Agreement or that other agreement or document.

 
(g)
A reference to a Party to this Agreement or another agreement or document includes the Party's successors, permitted substitutes and permitted assigns and, where applicable, the Party's legal personal representatives.

 
(viii)
A reference to legislation or to a provision of legislation includes a modification or re-enactment of, a legislative provision substituted for and a regulation or statutory instrument issued under such legislation or provision.

 
(ix)
A reference to conduct includes, without limitation, an omission, statement or undertaking, whether or not in writing.

 
(x)
A reference to an agreement includes any undertaking, deed, agreement and legally enforceable arrangement, whether or not in writing, and a reference to a document includes an agreement (as so defined) in writing and any certificate, notice, instrument and document of any kind.

 
(xi)
A reference to dollars and $ is to the currency of the United States of America.

2.
LICENSE

2.1
Grant of License, Conversion into Restricted License & Early Termination

In consideration of the injection of the sum of USD3,000,000 payable by HBL under the Subscription Agreement for the HBL 1st Issue Shares, and subject to the terms of this Agreement including, without limitation, due and timely payment of the royalty fees herein , ESI shall grant to CELLCURE as of the Completion Date and for the Term of the Agreement, an exclusive license, solely within the Field, under the Patent Rights and the Technology to Exploit Licensed Product and to conduct research and development on and otherwise improve, modify, Exploit and commercialize the Technology in the Territory both by itself and in conjunction with and through third parties;

 
-7-

 
 
Exclusive License Agreement - Execution Copy


PROVIDED that where:

 
(a)
HBL fails to procure the HBL Objective in full (and not part thereof), then the scope of the License grant in Clause 2.1 shall automatically be reduced to a Restricted License and Clause 2,9 shall apply;

 
(b)
HBL succeeds in meeting the HBL Objective in full but the Subsequent Objective is not met, then the scope of the License grant in Clause 2.1 shall automatically be reduced to a Restricted License and Clause 2.9 shall apply;

 
(c)
HBL fails to procure the HBL Objective in full and also fails to achieve the Condition Subsequent, the License shall terminate . and the provisions of Clause 2.10 shall apply. For the avoidance of doubt, ESI's sole remedy under such circumstances will be to terminate this Agreement, as provided herein.

2.2
Specific Conditions of Grant - Improvements

Save for and to the extent that there are limitations by third party rights or applicable law imposed on specific Improvements, the Parties agree that:

 
(a)
CELLCURE will provide full and prompt disclosure to ESI of any Outfield Improvements;

 
(b)
CELLCURE is deemed to be the owner of all Improvements created by or for CELLCURE;

 
(c)
CELLCURE grants to ESI a non-exclusive license to use ail Outfield Improvements as and when these are created solely for the purposes of ESI conducting (by itself or in conjunction with a third party) internal research outside the Field (or Restricted Field as the case may be);

 
(d)
CELLCURE shall not Exploit, solicit, enter into any negotiations or make any offer to any third party to license the Outfield Improvements for Exploitation outside of the Field (or Restricted Field as the case may be) without first soliciting ESI and offering a license of such Outfield Improvements to ESI, the following rules applying:

 
(1)
CELLCURE shall notify ESI of its intention to Exploit, solicit, enter into any negotiations or make any offer to any third party to license the Outfield Improvements for Exploitation outside of the Field (or Restricted Field as the case may be), by giving notice in writing and inviting ESI to enter into negotiations for the terms of such a license;

 
(2)
ESI will have thirty (30) days to respond in writing to CELLCURE to such notice by written confirmation of its intention to proceed with such negotiations;

 
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(3)
If ESI does not respond within the thirty (30) days, CELLCURE shall be free to proceed with the Exploitation, solicitation, negotiation or offer to third parties;

 
(4)
If ESI serves confirmation of its intention to proceed, the Parties will proceed to negotiate on a good faith best efforts basis to arrive at an agreement as to the terms of such a license consistent with industry standards;

 
(5)
If, in the event that no license is mutually agreed within three (3) months (or such other varied date as the Parties may mutually agree), CELLCURE shall be free to proceed with the Exploitation, solicitation, negotiation or offer to third parties in respect of the Outfield Improvement provided that CELLCURE may not offer or agree to any terms of license which are more favourable, in any material respect, to the licensee than the most favourable terms offered by CELLCURE to ESI. A full copy of the documents detailing particulars of such a license to a third party must be forwarded to ESI after execution of the same, subject to the confidentiality provisions of this Agreement.

2.3
Transfer and Ongoing provision of Technology

ESI shall transfer Technology in its possession to CELLCURE as of the Completion Date, either directly or through one or more of the Researchers, in a manner and as per a timetable to be agreed between the Parties. ESI shall keep CELLCURE currently apprised of new technology having application in the Field, throughout the Term of this Agreement.

2.4
Supply and Use of Progenitor Cells

ESI shall use commercially reasonable efforts to ensure that CELLCURE shall be given a reasonably timely and sufficient supply of Progenitor Cells and all ESI lines in reasonable quantities during the Term of this Agreement as may be requested by CELLCURE from time to time.

2.5
Warranties

ESI hereby warrants and undertakes to CELLCURE that:

 
(a)
it has the right and authority as the sole proprietors of the Patent Rights and the Technology, to grant to CELLCURE the rights under this Agreement;

 
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(b)
none of the Patent Rights or the Technology are subject to any charge, lien, or other encumbrance other than a debenture to Biomedical Sciences Investment Fund Pte Ltd ("BMS1F") under which the consent of BMSIF is required to transfer ownership of any ESI Patent Rights and Technology to third parties which shall have been procured prior to the Completion date, as a condition to Completion;
 
(c)
ESI is not a party to any technology transfer, exclusive license or other agreement or subject to any duty, obligation or restraint which restricts the free use or disclosure of any of the Intellectual Property Rights and Confidential Information in relation to the Patent Rights or Technology for the Field (or Restricted Field as the case may be) in accordance with the terms of this Agreement;
 
(d)
It has not and will not for the Term of this Agreement, license the Patent Rights or the Technology in the Field (or Restricted Field as the case may be);
 
(e)
It has not and will not grant the Researchers or any of them the right to Exploit or otherwise use or commercialize the Technology or the results of any academic research that they may conduct on the Technology, in the Field (or Restricted Field as the case may be);
 
(f)
For as long as this Agreement is in force and effect, it shall refrain from Exploiting the Patent Rights and the Technology in the Field (or Restricted Field as the case may be).

2.6
Acknowledgment and Warranties by CELLCURE

 
(a)
To the fullest extent permitted by law, CELLCURE acknowledges that ESI makes no warranties or representations in any form whatsoever, whether express, implied or statutory, including but not limited to warranties as to the satisfactory quality, acceptable quality merchantability or suitability for any particular purpose in connection with the Patent Rights or Technology, or the Exploitation of the Licensed Product or Patent Rights, or the non-infringement of any third party's rights, or the validity of any of the Patent Rights.
 
(b)
CELLCURE represents and warrants that the performance of all its obligations pursuant to this Agreement shall not conflict with any of its obligations pursuant to the provisions of any other agreement in effect between it and any person.
 
(c)
CELLCURE represents, warrants and covenants that it will use the Progenitor Cells provided to it pursuant to Clause 2,4 above for its own research purposes only and will not transfer the same to third parties. Moreover, CELLCURE shall not manufacture commercial products using the Progenitor Cells or offer such Progenitor Cells for commercial sale.
 
(d)
CELLCURE, with the assistance of HBL, shall use all reasonable commercial efforts to raise sufficient funds to carry out its business plan, including, without limitation, by applying to join the "Genesis Consortium" sponsored by the Office of Chief Scientist of the Israeli Ministry of Industry, Trade and Labor, if appropriate.

2.7
Right to Sub-license

 
(a)
CELLCURE may sub-license the rights granted under Clause 2.1 to anyone or more third parties in the Field (or Restricted Field as the case may be) provided that:

 
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(i)
CELLCURE informs ESI of all such sub-licences; and will provide ESI as soon as reasonably possible after the grant of such sub­licence a certified copy of such sub-licence subject to the confidentiality provisions of this Agreement;

 
(ii)
CELLCURE will undertake that any party to whom a sub-licence is granted pursuant to this Clause 2.7 will enter into an agreement with CELLCURE on terms which are consistent with the terms of this Agreement;

 
(iii)
upon the early termination of this Agreement, all sub-licenses granted to any sub-licensee pursuant to this Clause 2.7 will be automatically assigned to ESI so that such sub-license shall become a direct license between ESI and the sub-licensee.

 
(iv)
all sub-licences must state the full particulars of any consideration exchanged by CELLCURE and the sub-licensees;

 
(v)
any Sub-License Revenues paid by the sub-licensee shall be reflect the true and reasonable reflection of the commercial value of the sub-licence; and

 
(vi)
all sub-licences must provide the right to novate the same to ESI with the substitution of ESI for CELLCURE, as may be required by Clauses 2.9, 2.10 or 10.2(c).

 
(b)
For the avoidance of doubt, CELLCURE will procure that any person to whom a sub-licence is granted pursuant to this Clause 2.7 will be bound substantially by the terms and conditions of this Agreement governing the use of the Technology and Patent Rights, the scope of the license and confidentiality, except for payment obligations. CELLCURE will be liable to ESI for any failure of a sub-licensed person to perform the obligations ascribed to CELLCURE under this Agreement. Any such failure will be taken to be a failure of CELLCURE to perform the obligations ascribed to CELLCURE under this Agreement.

2.8
Exclusivity of the Licence

ESI agrees to refrain from granting any licence in the Field (or Restricted Field as the case may be) to any third party under new technology or cell lines that may be developed or obtained by ESI at any time during the Term.

2.9
Partial Claw-Back Provision

Where pursuant to Clause 2.1 (a) and (b), the License converts to a Restricted License and save for and to the extent that there are limitations by third party rights or applicable law imposed on specific Outfield Improvements:

 
(a)
CELLCURE shall, within seven (7) days of the date that triggers such conversion, make full disclosure to ESI of all Outfield Improvements which have not been disclosed to such date pursuant to Clause 2.2(a) and license such Outfield Improvements for utilization solely outside of the Restricted Field back to ESI for nominal consideration of N1S1.00. Such license to ESI shall be exclusive, irrevocable, perpetual, royalty-free, worldwide, assignable by ESI, with a right by ESI to grant sub-licenses, solely outside of the Restricted Field.

 
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(b)
undertake to do all things as may reasonably be required (including the execution of any further documents or take any reasonable steps) as may be required by relevant legislation, regulations or registration authorities to effect the license in Clause 2.9(a);

 
(c)
procure novations for all rights and interests in the sub-licenses executed in respect of applications save for those (and only for such component of those) within the Restricted Field forthwith (without assignment of liabilities of CELLCURE that may have accrued under the same), and in event of non- feasibility of the same, terminate such sub-licenses forthwith without liability to ESI.

 
(d)
indemnify ESI for any liabilities of CELLCURE that may have accrued prior to the novation of the relevant licenses in Clause 2.9(c).

2.10
Full Claw-Back Provision

Where pursuant to Clause 2 .1(c), where HBL fails to procure the HBL Objective in full (as opposed to failure to procure part thereof) and also fails to attain the Condition Subsequent, CELLCURE shall, save for and to the extent that there are limitations by third party rights or applicable law imposed on specific Improvements:

 
(a)
within seven (7) days of the date of the expiry of the relevant thirty six (36) month period, make full disclosure to ESI of all Improvements to date and license such Improvements back to ESI for nominal consideration of N1S1.00. Such license to ESI shall be exclusive, irrevocable, perpetual, royalty-free, worldwide, assignable by ESI, with a right by ESI to grant sub-licenses;

 
(b)
undertake to do all things as may be required (include the execution of any further documents or take any reasonable steps) as may be required by relevant legislation, regulations or registration authorities to effect the license in Clause 2.10(a);

 
(c)
procure novations for all rights and interests in the sub-licenses executed forthwith (without assignment of liabilities of CELLCURE that may have accrued under the same), and in event of non-feasibility of the same, terminate such sub-licenses forthwith without liability to ESI;

 
(d)
indemnify ESI for any liabilities that may have accrued prior to the novation of the relevant licenses in Clause 2.10(c); and

 
(e)
This Agreement shall be terminated, and the relevant provisions in Clause 10 will apply.


 
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3.
ROYALTIES & FINANCIAL PROVISIONS

3.1
Royalty Payments to ESI

 
(a)
During the Term of this Agreement, CELLCURE will pay to ESI the following royalties ("Royalties") namely, the sum equal to 10.75% of Sub License Revenue received by CELLCURE.

 
(b)
The payments due by CELLCURE to ESI pursuant to this Clause 3.1(a) will be made to ESI within thirty (30) days of the end of each calendar quarter, and each such payment will be accompanied by a written report signed by an appropriately authorised employee of CELLCURE and in a form reasonably satisfactory to ESI containing the calculation of the payment due to ESI for the relevant calendar quarter.

3.2
Registration Costs

All Registration Costs, up to a cumulative total of Two Hundred and Fifty Thousand US Dollars (USD250,000) within the first thirty-six (36) months of the Completion Date, and all Registration Costs thereafter will be borne by CELLCURE, although it is understood that responsibility for managing and prosecuting the Patent Applications to grant and ongoing maintenance thereof will be ESl's.

3.3
Records

CELLCURE will keep, and will cause any person to whom it has granted a sub­licence pursuant to Clause 2.7 to keep for a minimum of seven (7) years complete records of all matters which are relevant for determining the Royalties which are to be paid to ESI pursuant to this Agreement and will allow the authorised representatives of ESI access at any time to examine and make copies of such records,, Further, upon being given ten (10) or more days written notice by ESI, CELLCURE shall, until the end of the 7th year, make such records available for inspection at its premises at all reasonable times during business hours not more than twice in any calendar year by an independent auditor appointed by ESI for the purpose of verifying the accuracy of any statement or report given by CELLCURE to ESI and/or the amount of payments due. Any such auditor making such inspection shall be entitled to take copies or extracts from the records and books of account of CELLCURE. Prior to allowing access to such auditor, the auditor shall agree to keep confidential any information which it may acquire in the exercise of its duties under this clause with the exception of information which was already lawfully known to him/her, or which it is required to disclose by law, or which is in or enters the public domain otherwise than by any default of the auditor. Any such audit shall be performed at ESl's expense; provided, that the cost of such audit shall be paid by CELLCURE if such audit reveals a breach of the license terms by CELLCURE.

3.4
Default Interest

If CELLCURE fails to make any payment due pursuant to this Agreement by the due date, then it will pay ESI interest on the amount due from the date payment fell due until the amount is paid at the rate of LIBOR +3%, compounded on an annual basis.

 
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3.5
Withholding Taxes

If CELLCURE is required to pay withholding tax on any payments to be made under the terms of this Agreement, ESI shall bear all of such withholding taxes and CELLCURE shall deduct such taxes from payments due to ESI and forward the balance to ESI without any obligation to gross up such payment or pay ESI the amount so withheld. CELLCURE will provide ESI with documentary evidence that such tax has been paid to an appropriate authority to enable ESI to obtain the credit for such tax payment in its country of incorporation.

3.6
Method of Payment

All payments due by CELLCURE pursuant to this Agreement will be:

 
(a)
net payments and no deductions will be made except in respect of withholding tax in accordance with Clause 3.5;

 
(b)
made by bank draft or wire transfer;

 
(c)
non-refundable; and

 
(d)
payable in the currency of the United States of America and paid into such accounts not less than seven (7) days following the due date as ESI will direct in writing.

4
INTELLECTUAL PROPERTY

4.1
Infringement by Third Parties

 
(a)
A Party will promptly notify the other Party in writing of any alleged or threatened infringement within the Field (or Restricted Field as the case may be) of any patent included within the Patent Rights of which such Party becomes aware. Insofar as CELLCURE enjoys an exclusive licence in the relevant jurisdiction, CELLCURE will have the right to bring and control any action or proceeding with respect to such alleged or threatened infringement within the Field (or Restricted Field as the case may be) ("Proceeding") at its own expense and represented by legal advisers of its own choice.

 
(b)
In the event CELLCURE brings a Proceeding, ESI will co-operate fully with CELLCURE including, if required, undertaking any action or agreeing to be joined as a party to such Proceeding, the costs of which will be at CELLCURE'S expense, provided that:

 
(i)
ESI will retain the right to be represented by legal advisers of its own choice at ESl'S expense;

 
(ii)
CELLCURE will keep ESI fully informed of the status of such Proceeding on a weekly basis or, as reasonably requested by ESI, from time to time.

 
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(c)
In the event CELLCURE commences a Proceeding, ESI will be entitled to ten and three quarters of a percent (10.75%) of any recovery realised as a result of such Proceeding after reimbursement of any and all litigation expenses and reasonable costs of CELLCURE,

 
(d)
In the event ESI notifies CELLCURE in writing of any infringement referred to in Clause 4.1(a) and CELLCURE fails to commence a Proceeding within ninety days of being notified by ESI, ESI may commence a Proceeding at its own expense and may be represented by legal advisers of its own choice. In the event ESI brings a Proceeding, CELLCURE will provide all reasonable assistance to ESI in relation to such Proceeding and on the terms as set out in Clause 4.1 (b) as if CELLCURE were ESI and ESI were CELLCURE.

 
(e)
In the event ESI brings a Proceeding pursuant to Clause 4.1(d), ESI will be entitled to any recovery realised as a result of such Proceeding.

4.2
Infringement of Third Party Rights

Each Party will promptly notify the other Party in writing in the event that any allegation of infringement of any third party patent is raised by reason of the exercise by CELLCURE or any of its sub-licensees of any rights pursuant to Clauses 2.1 and 27 ("Alleged Third Patty Patent Rights"). In the event that such an action is brought by a third party, CELLCURE, or any sub-licensee of CELLCURE, as determined by CELLCURE, will have the right to control any defence of any such action at its own expense and represented by legal advisers of its own choice and ESI will have the right, at its own expense, to be represented in any such action by legal advisers of its own choice. In the event of any infringement or alleged infringement of any Alleged Third Party Patent Rights, both Parties will co-operate in good faith including any sub-licensee of CELLCURE (as the case may be) on a reasonable basis to negotiate and settle any dispute with a third party in relation to such infringement or alleged infringement of any Alleged Third Party Patent Rights and otherwise resolve any such infringement or alleged infringement and secure CELLCURE'S continued rights to the Alleged Third Party Patent Rights, if necessary or desirable.

4.3
Co-operation in Connection with Infringement Disputes

Without prejudice to Clause 4.1, in any suit or dispute involving infringement or alleged infringement within the Field by a third party of a patent included within the Patent Rights, or infringement or alleged infringement by CELLCURE of any Alleged Third Party Patent Rights, the Parties will co-operate fully and, upon the request and at the expense of CELLCURE, ESI will make available to CELLCURE at reasonable times and under appropriate conditions all relevant personnel, records, papers, information, samples, specimens and the like which are in its possession or control and provide CELLCURE with reasonable assistance in the conduct of any proceedings in relation to any such suit or dispute.

 
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4.4
Prosecution and Maintenance of Patent Rights

ESI shall provide CELLCURE reasonable opportunity to review and discuss with ESI prosecution strategy in respect of the Patent Rights from time to time during the Term hereof and consult with CELLCURE on the content of patent filings with respect to Improvements developed during the Term.

ESI undertakes to notify CELLCURE in writing, prior to the date prescribed by the relevant patent office or by applicable law for the taking of action with respect to the prosecution and/or maintenance of each of the Patent Rights (ESI hereby agreeing to irrevocably instruct its patent attorneys to notify CELLCURE of such event), if it does not desire to support the continued prosecution or appeals or maintenance of any of the Patent Rights. In the event ESI declines to pursue the filing, prosecution or maintenance of any of the Patent Rights, CELLCURE may, at its own expense, continue to prosecute or maintain such Patent Rights. For the avoidance of doubt, it is hereby clarified that should CELLCURE assume control over, and the expense of, filing, prosecution and maintenance of such Patent Right(s) as aforesaid, then (i) at any time thereafter CELLCURE may, in its sole and absolute discretion, cease the filing, prosecution and maintenance of such Patent Rights, upon prior written notice to ESI, and ESI shall not have any claim against CELLCURE in such regard; (ii) ESI shall assign to CELLCURE its right to receive payments from other ESI sub-licensees (if any) in respect of such Patent Right(s).

5.
GENERAL OBLIGATIONS OF CELLCURE

5.1
Diligence

CELLCURE will use commercially reasonable endeavours to develop and commercialise Licensed Products within the time frame shown by the Milestones. For the avoidance of doubt, if CELLCURE has not met the Milestones by the date set forth it will be deemed not to have used commercially reasonable efforts, unless otherwise determined pursuant to Clause 10.3(a)(iii).

5.2
Reporting

CELLCURE will submit a written report to ESI, which report will include general details of the progress of the scientific and development activities undertaken or implemented by CELLCURE, within ten (10) days of the conclusion of each successive period of six (6) calendar months for the Term of this Agreement and provide such other information in relation thereto as reasonably requested by ESI from time to time upon reasonable notice to CELLCURE.

6.
CONFIDENTIALITY

6.1
Obligations

Except as otherwise provided in this Clause 6, during the Term of this Agreement, and over a period of two (2) years thereafter, both CELLCURE and ESI will maintain in confidence and use only for the purposes of this Agreement Confidential Information, including, inter alia, data resulting from or related to the development of Licensed Product and the development and use of the Patent Rights and the Technology in the Field pursuant to this Agreement.

 
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6.2
Permitted Disclosures

To the extent it is reasonably necessary to fulfil its obligations or exercise its rights pursuant to this Agreement, either Party may disclose Confidential Information it is otherwise obligated pursuant to this Clause 6 not to disclose to an Affiliate, a sub-licensee or a potential sub-licensee (with whom that Party has conducted substantive bona fide negotiations) of the Patent Rights and Technology on a need-to- know basis on condition that such person or persons (as the case may be) agree to keep the Confidential Information confidential for the same time periods and to the same extent as that Party is required to keep the Confidential Information confidential. Either Party may also disclose Confidential Information to government or other regulatory authorities to the extent that such disclosure is reasonably necessary to obtain a patent or authorisation to conduct a clinical trial with or to commercially market any Licensed Product, provided that such disclosures are kept confidential and limited only to the scope and extent necessary for the purpose.

6.3
Terms of this Agreement

Save for where ESI or HBL wishes to disclose the financial aspects or terms only of this Agreement for the purposes of fund raising or any retail offering of investments (in which case no prior written consent of the other Party is needed), CELLCURE and ESI agree not to disclose any financial terms or conditions of this Agreement to any third party without the prior written consent of the other, except as required by applicable law or to persons with whom CELLCURE or ESI (as the case may be) has entered into or proposes to enter into a business relationship provided that third party is bound by confidentiality obligations. Notwithstanding the foregoing:

 
(a)
Either Party will be permitted to disclose the material financial terms of this Agreement to any potential acquirer, merger partner or other bona fide potential strategic partner of such Party provided that any such potential acquirer, merger, partner or other bona fide strategic partner is bound by confidentiality obligations consistent with this Agreement and further provided that the other Party is advised of the existence and the identity of such potential acquirer, merger partner or other bona fide strategic partner and the nature of the disclosure to be made prior to such disclosure being made to the extent it is permitted to do so; and

 
(b)
CELLCURE and ESI will be permitted to disclose the terms or conditions of this Agreement in accordance with the requirements of the rules of any stock exchange or securities body without the prior written consent of the other but only to the extent required by such rules.

 
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6.4
Public Comment

Without prejudice to the other terms of this Clause 6, neither Party will make any public comment either verbally or in writing concerning or arising from this Agreement without first providing the other Party with seventy-two (72) working hours to review, and provide its approval for such announcement, which approval shall not be unreasonably withheld, and further provided that if no comments are provided within seventy-two (72) working hours the announcement will be deemed to be approved. Each Party will be permitted, however, to make any public comment which is required accordance with the rules of any stock exchange or securities body without the prior written consent of the other Party but only to the extent required by such rules.

7
LIMITATION OF LIABILITY AND INDEMNITY

 
(a)
To the extent permitted by law, ESI and any of its servants, agents, sub-contractors or nominees are not liable for any liabilities, losses, damages, charges, claims, actions, costs and expenses suffered or incurred by CELLCURE arising out of or in connection with this Agreement, except as they arise as a result of ESI's breach of this Agreement, gross negligence or wilful misconduct.

 
(b)
CELLCURE Indemnifies and releases and will keep indemnified and released and agrees to defend ESI and any of its servants, agents, sub-contractors or nominees against all liabilities, losses, damages, charges, claims, actions, costs and expenses (including without limitation legal fees calculated on a solicitor/client basis) of any kind whatsoever suffered or incurred by any of them as a result of or in connection with CELLCURE'S exercise of the License or the Restricted License granted pursuant to Clause 2 or sub-licences granted pursuant to Clause 2.7 or by reason of any defect or deficiency in a Licensed Product, except as they arise as a result of ESI's breach of this Agreement, gross negligence or wilful misconduct.

8
INSURANCE

CELLCURE, at its own cost, shall insure itself with adequate liability insurance, against all perils which can reasonably be foreseen in connection with clinical trials and other tests in connection with the development, sale and use of Licensed Product. At ESI's request, CELLCURE shall cause ESI to be a named insured under any and all such policies. CELLCURE shall furnish ESI with copies of all such policies and evidence of the continuation thereof in force, throughout the Term.

9
FORCE MAJEURE

 
(a)
Each Party shall be relieved of its obligations under this Agreement to the extent that fulfillment of such obligations shall be prevented by strikes, embargoes, riots, fires, floods, hurricanes, windstorms, acts or defaults of common carriers, governmental laws, acts or regulations, contamination, shortages of materials or any other occurrence (except for war), whether or not similar to the foregoing, beyond the reasonable control of the Party whose performance is affected thereby.

 
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(b)
if any Party is prevented from fulfilling its obligations under this Agreement by reason of a circumstance covered by this Clause 9, the Party unable to fulfill its obligations shall, upon the occurrence of any such circumstance, promptly notify the other Party of such circumstance and of the likely duration thereof, use its reasonable commercial efforts to alleviate each circumstance and promptly continue performance hereunder upon the cessation of such circumstance.

10
TERM AND EARLY TERMINATION

10.1
Term

Unless terminated earlier pursuant to this Agreement, this Agreement will continue on a worldwide basis until:

 
(a)
the date which is the date of expiration of the last to expire (being the lawful expiration or extinction) of any Intellectual Property Rights in the Patent Rights; or

 
(b)
early termination as provided for in Clause 2.10 or 10.3(a); or

 
(c)
upon the termination or nullification of the Subscription Agreement and the Shareholders Agreement, due to a failure to attain Completion;

 
(d)
CELLCURE ceases the business related to the Field (or the Restricted Field as the case may be);

Whichever is earlier.

10.2
Effect of Termination

 
(a)
If this Agreement is duly terminated by ESI under Clause 10.1(d) or 10.3(a) below, the Licences granted pursuant to this Agreement will immediately cease and CELLCURE will cease to make any use of the Patent Rights and Technology and all Improvements shall be treated in the same manner as in a full claw-back as provided for in Clause 2.10.

 
(b) 
If this Agreement expires by reason of the passage of time as provided in Clause 10.1(a), CELLCURE shall thereafter be free to grant sub-licenses, Exploit Licensed Products and to utilize the Technology in the Field, without being liable to pay license fees, royalties, sub-licensing fees or any form of consideration to ESI.

 
(c)
Without prejudice to any other terms of this Agreement, CELLCURE will pay to ESI any outstanding amounts owing to ESI that would have been due and payable and the provisions.

 
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Exclusive License Agreement - Execution Copy


10.3
Early Termination

 
(a)
in addition to any rights it may have under this Agreement, ESI may terminate this Agreement with immediate effect upon the occurrence of any of the following:

 
(i)
upon or after the bankruptcy, insolvency, dissolution, liquidation or winding up of CELLCURE (other than dissolution or winding up for the purposes of a solvent reconstruction or amalgamation);

 
(ii)
upon or after the breach of any material provision of this Agreement by CELLCURE, if CELLCURE has not remedied the breach within thirty (30) days after written notice by ESI, or in the case of delinquent payments of Royalties, within forty-five (45) days after written notice by ESI; or

 
(iii)
any of the Milestones are not met by the specified dates (in which case, however, ESI's sole remedy will be to terminate this Agreement; it being understood and agreed, however, that if the failure of CELLCURE to meet any Milestone by the specified date is attributable solely to circumstances beyond its control, and provided that CELLCURE exerted its best efforts to meet such Milestone, then such failure shall not be deemed a failure by CELLCURE to meet a Milestone for purposes of this Clause 10.3(a)(iii))

 
(b)
If this Agreement is duly terminated under Clause 10.1(d), or 10.3(a) above CELLCURE will immediately:

 
(i)
supply to ESI all documents, reports, notes, memoranda, computer media or other materials (and any copies thereof In any form) which record, contain or relate in any way to the Technology and Patent Rights and which were provided to or obtained by CELLCURE or prepared or made by or for or on behalf of CELLCURE;

 
(ii)
return the Confidential Information (and any copies thereof in any form) of ESI;

 
(iii)
cease to make use of Confidential Information;

 
(iv)
return or destroy Progenitor Cells provided to CELLCURE pursuant to Clause 2.4 above, as instructed by ESI in writing,
 
and will confirm in writing to ESI promptly when it has complied with these obligations.
 
 
(c)
CELLCURE acknowledges that in respect of materials supplied in Clause 10.3 (b) arising from human clinical trials of Licensed Products that ESI will be entitled to utilise such materials for regulatory submissions seeking marketing approval of Licensed Products in the Field, without the consent of CELLCURE. For the avoidance of doubt CELLCURE acknowledge that ESI can utilise any other material supplied pursuant to Clause 10.3(b) for regulatory submission purposes.

 
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(d)
In addition to any rights it may have under this Agreement, CELLCURE may terminate the Agreement with immediate effect upon the occurrence of any of the following:

 
(i)
upon or after the winding up of ESI (other than a winding up for the purposes of a solvent reconstruction or amalgamation);

 
(ii)
upon or after the breach of any material provision of this Agreement by ESI, if ESI has not remedied the breach within thirty (30) days after written notice by CELLCURE,

10.4
Survival of Accrued Obligations and certain Provisions of this Agreement

 
(a)
Expiration or termination of this Agreement will not relieve the Parties of any obligation accruing prior to such expiration or termination.

 
(b)
Clauses 2.7(a)(iii), 6, 7, 10.2, 10.3, this 10.4, 11, 12, 14, 16, 18, 19, 20 and 21 hereof shall survive the termination of this Agreement for any reason.

11
RESOLUTION OF DISPUTES

11.1
Suspension of Agreement

Notwithstanding anything to the contrary in Clause 10.2 or Clause 10.3 of this Agreement, to the extent that a party (the "Respondent") reasonably and in good faith disagrees with any assertion by the other party (the "Claimant") that there has been a material breach or material default of this Agreement by Respondent, its Affiliates or, in the case of CELLCURE, a sub-licensee, and Respondent provides written notice to Claimant of its disagreement and the basis for its belief (a "Rebuttal Notice") within fifteen (15) days after Respondent receives notice from Claimant of a breach, this Agreement will remain in effect and any termination of this Agreement hereunder will be suspended pending resolution of such disagreement between the Parties as provided in this Section 11, The Parties will attempt to resolve such disagreement as expeditiously as possible and Respondent will continue to comply with the provisions of this Agreement, to the extent that they are not the subject of the disagreement between the Parties.

11.2
Initial Dispute Resolution Efforts

The Parties shall attempt to resolve any dispute, controversy, or claim arising out of, or in connection with, this Agreement amicably and promptly by negotiations between executives who have authority to settle the controversy. Within seven (7) days after delivery of a Rebuttal Notice, executives of the Parties shall agree to meet at a mutually acceptable time and place, and thereafter as often as they reasonably deem necessary, to attempt to resolve the dispute. If the matter has not been resolved within thirty (30) days of the Rebuttal Notice, either Party may, by further notice (a "Dispute Escalation Notice") to the other Party, refer the matter to the respective Chief Executive Officers of the Parties. Such officers shall negotiate in good faith to resolve the matter in an amicable manner within thirty (30) days of the Dispute Escalation Notice, In the event the matter is not resolved within such thirty (30) days, either Party may initiate arbitration of the dispute as provided for in Clause 11.3 below.

 
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Exclusive License Agreement - Execution Copy


11.3
Arbitration

In the event that compliance with Clauses 11.1 and 11.2 fails to resolve such dispute within the time frames set out therein, such dispute shall be referred to and finally resolved by arbitration in Singapore in accordance with the Rules of Singapore International Arbitration Centre for the time being in force which rules are deemed to be incorporated by reference into this clause. A tribunal shall consist of a single arbitrator to be appointed by the agreement of the Parties, and failing such agreement, in accordance with the said Rules. The language of the arbitration shall be English. The Parties hereto undertake to keep the arbitration proceedings and all information, pleadings, documents, evidence and all matters relating thereto confidential.

12.
NOTICES

Any notice, demand, consent or other communication, including, without limitation, a Rebuttal Notice and a Dispute Escalation Notice (each, a "Notice") given or made under this Agreement:

 
(a)
must be in writing and signed by a person duly authorised by the sender;

 
(b)
must either be delivered to the intended recipient by prepaid post (if posted to an address in another country, by airmail) or by hand or overnight carrier to the address or fax number below or the address last notified by the intended recipient to the sender:

 
(i)
to CELLCURE:
c/o Hadasit Medical Research Services and Development Ltd.
Kiryat Hadassah, PO Box 12000
Jerusalem 91120, Israel
Fax: + 972 2 643 7712
Attn: The Managing Director

with a copy (which will not constitute notice):
Baratz, Horn & Co .
1 Azrieli Center
Round Tower, 18th Floor
Tel-Aviv 67021, Israel
Fax: +972-3-6960986
Attn: Yael Baratz

 
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Exclusive License Agreement - Execution Copy


 
(ii)
to ESI:
#05-06 Helios,
11 BiopolisWay,
Singapore 138667
Attn: The Managing Director
Attn: The Managing

 
(c)
wiil be taken to be duly given or made:

 
(i)
in the case of delivery in person, when delivered;

 
(ii)
in the case of delivery by post, or overnight carrier five days after the date of posting (if posted to an address in the same country) or fourteen days after the date of posting (if posted to an address in another country); and

 
(iii)
in the case of fax, on receipt by the sender of a transmission control report from the despatching machine showing the relevant number of pages and the correct destination fax machine number or name of recipient and indicating that the transmission has been made without error,

but if the result is that a Notice would be taken to be given or made on a day that is not a business day in the place to which the Notice is sent or is later than 4:00pm (local time) it will be taken to have been duly given or made at the commencement of business on the next business day in that place.

13.
AMENDMENT

No amendment or variation of this Agreement is valid or binding on a Party unless made in writing executed by both Parties.

14.
ASSIGNMENT

14.1
No Assignment Without Consent

Subject to Clause 14.2 neither Party may assign or otherwise transfer this Agreement or any of its rights or obligations herein without the prior written consent of the other Party, which consent wiil not be unreasonably withheld, save that this will be without prejudice to the right of CELLCURE to grant sub-licenses and to contract with third party subcontractors in connection with clinical research organisations or contract production with respect to the development and manufacture of Licensed Products.

14.2
Permitted Assignments

Notwithstanding Clause 14.1, any Party may assign this Agreement:

 
(i)
without the prior written consent of the other Party in connection with the sale of all or substantially all of the assets or equity of that Party, provided that such acquirer undertakes in writing to be bound by all the terms and conditions in this Agreement and the other Party is notified within ten (10) days of such assignment taking place; and

 
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Exclusive License Agreement - Execution Copy


 
(ii)
Either Party may assign this Agreement to an Affiliate provided that such Affiliate undertakes to be bound by the terms and conditions of this Agreement.

15.
FURTHER ASSURANCES

Each Party agrees to do all things and execute all deeds, instruments, transfers or other documents as may be necessary or desirable to give full effect to the provisions of this Agreement and the transactions contemplated by it.

16.
RELATIONSHIP OF THE PARTIES

This Agreement does not set up or create an employer/employee relationship, agency, partnership of any kind, an association or trust between the Parties, each Party being individually responsible only for its obligations as set out in this Agreement and in addition the Parties agree that their relationship is one of independent contractors, CELLCURE is not authorised or empowered to act as agent on behalf of ESI and will not on behalf of ESI enter into any contract, warranty or representation as to any matter. ESI will not be bound by the acts or conduct of CELLCURE.

17.
COSTS

Except as provided in the Subscription Agreement, each Party will bear its own costs arising out of the negotiation, preparation and execution of this Agreement.

18.
GOVERNING LAW AND JURISDICTION

This Agreement is governed by the laws of Singapore. The Parties submit to the exclusive jurisdiction of the Singapore courts and courts of appeal therefrom in connection with all matters concerning this Agreement.

19.
SEVERABILITY

Any part of this Agreement is severable and if a court determines that a part of this Agreement is unenforceable, illegal or void then the court may sever that part without affecting the validity of the other parts of this Agreement.

20.
WAIVER

No failure to exercise or delay in exercising any right, power or remedy by a Party will operate as a waiver nor will any single or partial exercise of any right, power or remedy preclude any other or further exercise of that right, power or remedy.

21.
ENTIRE AGREEMENT

This Agreement constitutes the entire agreement between the Parties in relation to the subject matter of this Agreement and supersedes ail prior oral and written communications, understandings, arrangements and agreements relating to the subject matter of this Agreement.

 
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Exclusive License Agreement - Execution Copy


22.
COUNTERPARTS

This Agreement may be executed in any number of counterparts. All counterparts together will be taken to constitute one instrument.

[The remainder of this page has intentionally been left blank]

 
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Exclusive License Agreement - Execution Copy


SCHEDULE 1
Patent Appficatlons
 
 
S.No
Category
Title
Country
Appin./ Pat. #
Status
 
Neural differentiation
Embryonic stem cells and neural progenitor cells derived therefrom
PCT
PCT/AU 01/00278
Entered National phase
1
 
 
Australia
779694
Registered
2
divisional
 
Australia
2005200148
Not examined
3
 
 
Canada
2403000
Examination requested
4
 
 
Japan
2001-567299
 
5
 
 
Israel
151170
Awaiting examination report
6
 
 
Europe
01911277.0
In abeyance
7
 
 
Singapore
90819
Registered
8
 
 
USA
09/808382
Examiner interview taken place on 28 Feb 2006
9
continuation
 
USA
11/049830
Filed
10
CIP
Embryonic stem cells and neural progenitor cells derived therefrom (inciudes transplantation of NPCs)
Australia
2002301347
Not Examined
11
 
 
Canada
2406610
To request Examination
12
 
 
Japan
2002-292682
Awaiting examination
13
 
 
Israel
152106
Awaiting Examination report
14
 
 
Europe
02256974.3
Restriction made
15
 
 
Singapore
200206039-0
Search & Examination
16
 
 
USA
7011828
Patent Granted
17
continuation
 
USA
11/238574
Filed

 
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Exclusive License Agreement - Execution Copy

 
 
BMP
modulation
Method of confrolling differentiation of embryonic stern cells by culturing ES cells in the presence of, (Noggin)
PCT
PCT/AU01/0073 5
National Phase
18
 
 
Australia
2001265704
Response to first report filed
19
 
 
Canada
2411914
Awaiting Examination
20
 
 
Japan
2001-504612
Examn request due
21
 
 
Israel
153095
Awaiting Examination
22
 
 
Europe
01942909
Awaiting Examination
23
 
 
Singapore
93380
Registered
24
 
 
USA
09/885679
Met with examiner, May 2005,, Request forContd,, Examination
 
Dopaminergic neurons
Stem cells
PCT
PCT/AU03/0070 4
National Phase
25
 
 
Australia
2003229132
Not examined
26
 
 
Canada
2488429
Examination request due
27
 
 
Europe
03724662.6
Awaiting Examination
28
 
 
U.K.
0428149.9
Awaiting Examiner's response
29
 
 
Singapore
108144
Registered
30
 
 
USA
11/005518
Restriction made, Await Exam report

 
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Exclusive License Agreement - Execution Copy


SCHEDULE 2
 
 Milestones
 
o
Demonstrated statistical efficacy in a non GLP primate model of Parkinson's Disease with a Licensed Product by 31 December 2010
 
o
Demonstrated statistical efficacy in a GLP primate model of Parkinson's Disease with a Licensed Product by 31 December 2011
 
o
Approval of an IND or the European equivalent for clinical testing of a Licensed Product by 31 December 2012
 
o
Marketing Approval by either FDA or EMEA of a Licensed Product by 31 December 2016

 
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Exclusive License Agreement - Execution Copy


SCHEDULE 3
 
General Description of the Technology Currently in the Possession of ESI
 
ESI know-how relating to basic hES culture and maintenance as relevant to the generation of NPC's
 
ESI know-how relating to transportation and shipment of hES cells

 
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Exclusive License Agreement - Execution Copy


EXECUTED as an agreement.

SIGNED for and on behalf of
CELL CURE NEUROSCIENCES LTD.
By:
 
 
 
 
 
Its:
 
 
 
 
 
Alan Colman
  /s/ Alan Colman
(print name)
 
(signature)
 
 
 
Witness
 
 
 
 
 
Suresh Chandran
 
/s/ Suresh Chandran
(print name of witness)
 
(signature)
 
 
 
SIGNED for and on behalf of
ES CELL INTERNATIONAL PTE LTD
By:
 
 
 
 
 
Its:
 
 
Alan Colman
 
/s/ Alan Colman
(print name)
 
(signature)
 
 
 
Witness
 
 
Douglas Alliston
 
/s/ Douglas Alliston
(print name of witness)
 
 
 
 
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FIRST AMENDMENT TO EXCLUSIVE LICENSE AGREEMENT

This First Amendment (the "First Amendment") to that certain Exclusive License Agreement of' March 22, 2006 (the "Agreement") by and between CELL CURE NEUROSCIENCES LTD., a corporation duly incorporated under the laws of' the State of' Israel, c/o Hadasit Medical Research Services and Development Ltd, Kiryat Hadassah, PO Box 12000, Jerusalem 91120, Israel ("CELLCURE") and ES CELL INTERNATIONAL PTE. LTD., a corporation duly incorporated under the laws of the Singapore, having its principal place of business at #05-06 Helios, 11 Biopolis Way, Singapore 138667 ("ESI") is made effective as of the Completion Date (as such term is defined in the Agreement).
 
 
WHEREAS, the parties hereto entered into the Agreement where ESI granted CELLCURE an exclusive license for the exploitation of certain patent rights and technology; and
 
 
WHEREAS, CELLCURE and ESI have agreed to amend the Agreement as more fully set forth below.
 
 
NOW, THEREFORE, the Parties hereby agree as follows:
 
 
1.
Section 2 4 of the Agreement is hereby deleted in its entirety. A new Section 2.4 is hereby added to the Agreement, which shall read as follows:
 
 
 
"2 4.
ESI shall use commercially reasonable efforts to ensure that CELLCURE shall be given a reasonably timely and sufficient supply of Progenitor Cells and ESI lines in reasonable quantities during the Term of this Agreement as maybe requested by CELLCURE from time to time. Progenitor Cells shall be provided to Cell Cure without charge. Any other research-grade ESI cell line applicable in the Field or Restricted Field (as the case may be) and related and relevant documentation shall be provided to CELLCURE for internal research purposes (which can also be carried out through sub-contractors) without charge. Commercial exploitation by CELLCURE of these lines or clinical grade ESI cell lines and related documentation in the Field or Restricted Field (as the case may be) will be made under a separate license (the "Cell Lines License") which shall be charged by ESI to CELLCURE on a most favored nation basis. Any amounts paid by CELLCURE to ESI in consideration for the Cell Lines License, shall be creditable against any future Royalties that may become payable by CELLCURE to ESI hereunder, if the source of the revenue stems from the same Licensed Product developed under the Cell Lines License."

 
1

 

2.
The following shall be added to Schedule 1 of the Agreement:
 
 
S.No
Category
Title
Country
Appln, /Pat#
Status
31
Embryonic Stem Cells
A method of preparing undifferentiated human embryonic stem cells
Israel
142,748
GRANTED
 
3.
Except as expressly amended hereby, the Agreement shall continue in full force and effect. Ihis First Amendment is incorporated and made a part of the Agreement between CELLCURE and ESI.
 
[INTENTIONALLY LEFT BLANK]

 
2

 

IN WITNESS WHEREOF, the patties, each by its duly authorized signatory, have caused this instrument to be executed as of the date first above-mentioned.
 
 
By:
/s/ Charles S. Irving
 
CELL CURE NEUROSCIENCES LTD.
 
 
 
By:
Charles S. Irving
 
 
 
 
Title:
COO
 
 
 
 
Date:
11 Apr 2007
 
 
 
 
/s/ Alan Colman
 
ES CELL INTERNATIONAL PTE. LTD.
 
 
 
By:
 
 
 
 
 
Title:
 
 
 
 
 
Date:
 
 

 
3

 

SECOND AMENDMENT TO EXCLUSIVE LICENSE AGREEMENT
 
This Second Amendment (the "Second Amendment") to that certain Exclusive License Agreement, dated March 22, 2006, as amended by the First Amendment to Exclusive Licence Agreement, (the "Agreement") by and between CELL CURE NEUROSCIENCES LTD. a corporation duly incorporated under the laws of the State of Israel, c/o Hadasit Medical Research Services and Development Ltd., Kiryat Hadassah, PO Box 12000, Jerusalem 91120, Israel ("CELLCURE") and ES CELL INTERNATIONAL PTE. LTD., a corporation duly incorporated under the laws of the Singapore, having its principal place of business at #05-06 Helios, 11 Biopolis Way, Singapore 138667 ("ESI") is made effective as of 1 March 2008.
 
WHEREAS, the parties hereto entered into the Agreement where ESI granted CELLCURE an exclusive license for the exploitation of certain patent rights and technology; and
 
WHEREAS, CELLCURE and ESI have agreed to amend the Agreement as more fully set forth below.
 
NOW, THEREFORE, in consideration of the mutual promises and covenants set forth herein, the parties hereby agree as follows:
 
1.
The following new definitions are hereby added in Clause 1.1 (Definitions) of the Agreement:
 
"Effective Date of Second Amendment" means 1 March 2008.
 
"ESNATS Project means a joint collaborative research project entitled "Embryonic Stem cell-based Novel Alternative Testing Strategies" funded by the European Commission.
 
The Consortium Agreement means a Consortium Agreement for the performance of the ESNATS Project entered into by CELLCURE on 4 March 2008, effective as of 1 April 2008 and all amendment thereto."
 
2.
The definition of "Field" is Clause 1.1 (Definitions) of the Agreement is hereby deleted in its entirety and replaced by the following definition:
 
"Field" means the development and exploitation of hES cell derived neural cells solely for cell replacement therapy of neurodegenerative diseases in a humans and conditions involving retinal degeneration.
 
3.
The following new paragraph shall be added at the end of Clause 2.1 (Grant of License) of the Agreement:
 
"With effect from the Effective Date of the Second Amendment, ESI hereby grants to CELLCURE a non-exclusive license under the Patent Rights and the Technology for the research, development, exploitation and/or use of hESC derived neural cells for drug toxicity and efficacy testing by CELLCURE and/or in conjunction with or through third parties, including, without limitation, within the framework of and/or arising from the ESNATS Project pursuant to the Consortium Agreement, all subject to and in accordance with the terms and conditions of this Agreement ("the Non-Exclusive License").
 
4.
The definition of License in Clause 1.1 (Definitions) of the Agreement is hereby deleted in its entirety and is replaced by the following definition:

 
1

 

"License means (i) the grant of the rights and licenses granted to CELLCURE for use of the Technology and Patent Rights in the Field in Clause 2.1 of this Agreement; and (ii) the grant of the Non-Exclusive License, as provided in Clause 2.1 of this Agreement."
 
5.
The Parties agree that all inventions, know-how, and other results which are created or generated by CELLCURE during the course of and/or arising from any research, development, exploitation and/or use of hESC derived neural cells for drug toxicity and efficacy testing under the Non-exclusive License, including, for the removal of doubt, all inventions, know-how, and other results which are created or generated by CELLCURE during the course of and/or arising from its participation in the ESNATS Project and which are owned by CELLCURE under the Consortium Agreement, shall constitute Improvements and Outfield Improvements, respectively, as defined in Clause 1.1 of the Agreement.
 
6.
Section 2.4 of the Agreement is hereby deleted in its entirety. A new Section 2.4 is hereby added to the Agreement, which shall read as follows:
 
 
"2.4.
ESI shall use commercially reasonable efforts to ensure that CELLCURE shall be given a reasonably timely and sufficient supply of Progenitor Cells and other ESI human Embryonic Stem (hES) cell lines in reasonable quantities during the Term of this Agreement as may be requested by CELLCURE from time to time. Progenitor Cells shall be provided to Cell Cure without charge except for costs of shipping. Any other research-grade ESI hES cell line applicable in the Field or Restricted Field (as the case may be) and related and relevant documentation shall be provided to CELLCURE for internal research purposes (which can also be carried out through sub-contractors) without charge except for costs of shipping. Such research grade lines shall be at a passage level similar to that of clinical grade ESI Cell Lines For purposes hereof, "sufficient supply" and "reasonable quantities" shall mean sufficient material to start a seed lot system (i.e. two "straws" of cells) with back-up cells as required from time to time. Commercial exploitation by CELLCURE of these cell lines or GMP -grade ESI cell lines and related documentation in the Field or Restricted Field (as the case may be) will be made under a separate license (the "Cell Lines License") which shall be charged by ESI to CELLCURE on a most favored nation basis. Any amounts paid by CELLCURE to ESI in consideration for the Cell Lines License, shall be creditable against any future Royalties that may become payable by CELLCURE to ESI hereunder, if the source of the revenue stems from the same Licensed Product developed under the Cell Lines License, "
 
7.
Schedule 2 to the Agreement is hereby deleted in its entirety and replaced with the revised Schedule 2 attached hereto as Exhibit A.
 
8.
Except as expressly amended hereby, the Agreement shall continue in full force and effect. This Second Amendment is incorporated and made a part of the Agreement between CELLCURE and ESI.

 
2

 

IN WITNESS WHEREOF, the parties, each by its duly authorized signatory, have caused this instrument to be executed as of the date first above-mentioned.

/s/ Dr. Raphael Hofstein
 
CELL CURE NEUROSCIENCES LTD.
 
 
 
By:
Dr. Raphael Hofstein
 
     
Title:
Com Chair
 
     
Date:
1/2/09
 
 
 
 
/s/ Lawrence Chin
 
ES CELL INTERNATIONAL PTE. LTD.
 
   
By:
Lawrence Chin
 
 
   
Title:
Director
 
 
   
Date:
17 Feb 2009
 

 
3

 

Exhibit A
 
SCHEDULE 2
 
Milestones
 
 
Demonstrated statistical efficacy in a suitable non GLP animal model of Parkinson's  Disease, Multiple Sclerosis or retinal degenerative disorders  with a Licensed Product by 31 December 2010;

 
Demonstrated statistical efficacy in a suitable GLP animal model of Parkinson's Disease, Multiple Sclerosis or retinal degenerative disorders with a Licensed Product by 31 December 2011;

 
Approval of an IND or the European equivalent for clinical testing of a Licensed Product by 31 December 2012;

 
Marketing  Approval  by either  FDA  or  EMEA of  a Licensed  Product  by 31 December 2016.
 
 
*******
 
 
4

 

AMENDED AND RESTATED RESEARCH AND LICENSE AGREEMENT

This Amended and Restated Research and License Agreement (this “Amendment”) is made and entered into as of the Date of Amendment (as defined herein), as an amendment of the Research and License Agreement signed between the Parties on the Effective Date (the "Original Agreement", and, as amended by this Amendment, the "Agreement"), by and between: HADASIT MEDICAL RESEARCH SERVICES AND DEVELOPMENT LTD., a company duly incorporated under the laws of Israel (“Hadasit”) and CELL CURE NEUROSCIENCES LTD., a company duly incorporated under the laws of Israel (the “Company”) (each a “Party” and jointly the “Parties”).

WHEREAS,
in the course of research conducted at Hadassah Medical Organization (“HMO”), by Prof. Benjamin Reubinoff ("Prof. Reubinoff") and his other HMO colleagues (collectively the “Researchers”), the Researchers arrived at certain inventions, being the subject of and more fully described in the PCT patent applications listed in Annex A hereto (the “Patent Applications”), and created and/or generated the technology described therein and related Know-How (defined below); and

WHEREAS,
Hadasit is the commercial arm and a wholly-owned subsidiary of HMO; and

WHEREAS,
Hadasit is the exclusive owner of all right, title and interest in and to the Patent Applications and the Licensed Technology (defined below); and

WHEREAS,
the Company is engaged in the development and commercialization of cell therapy applications for neurodegenerative diseases; and

WHEREAS,
the Company wishes to receive, and Hadasit is willing to grant to the Company, an exclusive, worldwide, royalty bearing license (with the right to grant sublicenses subject to the terms of Section 2.4 below), to use, commercialize and/or exploit the Licensed Technology or any part thereof, in any manner whatsoever and for any purpose or indication whatsoever in the Field (as defined hereafter), all subject to and in accordance with the terms and conditions of this Agreement, and

WHEREAS,
the Company wishes to receive and Hadasit is willing to procure the provision to the Company by HMO of the Licensed Materials (as defined below) for use under the license granted hereby, all subject to and accordance with the terms and conditions of this Agreement.

 
- 1 -

 

NOW THEREFORE IT IS AGREED BETWEEN THE PARTIES AS FOLLOWS:

 
1.
Definitions and Interpretation

 
1.1.
The Preamble and Annexes hereto form an integral part of this Agreement

 
1.2.
In this Agreement the following terms shall bear the meanings assigned to them below, unless the context shall indicate a contrary intention:

 
1.2.1.
Additional Research Agreement” shall mean an agreement, attached hereto as Annex E, governing additional sponsored research to be carried out by HMO for the Company in the field of stem cell applications for neurodegenerative diseases beyond the scope of the Product Development Program, pursuant to which the Company shall commit to transfer the Annual Additional Research Funds to Hadasit to fund additional research at HMO in a total amount of US$ 1,500,000 (One Million Five Hundred Thousand US Dollars), as per the detailed research plan(s) to be mutually agreed upon thereunder.

 
1.2.2.
"Annual Additional Research Funds" shall mean the sum of US$ 300,000 (Three Hundred Thousand US Dollars).

 
1.2.3.
Affiliate shall mean any person who, directly or indirectly, controls or is controlled by, or is under direct or indirect common control with the Company. For the purposes of this definition, control” shall mean the holding, directly or indirectly, of more than 50% (fifty percent) of the issued share capital or the voting power of the Company, or the holding, directly or indirectly, of a right to appoint more than 50% (fifty percent) of the directors of the Company or of the right to appoint the chief executive officer of the Company.

 
1.2.4.
Company IP” shall have the meaning ascribed to such term in Section 8.4 below.

 
1.2.5.
“Confidential Information” shall have the meaning ascribed to such term in Section 11.1 below.

 
1.2.6.
Controlled IP” shall mean, with respect to Intellectual Property (other than the Licensed Technology and the Licensed Materials) developed at HMO in the laboratory of Prof. Reubinoff without the use of the Company's manpower, resources or Intellectual Property, the possession, as will be determined at any relevant time for the purposes of Sections 6.4 and 7.5 as applicable, by HMO and/or Hadasit of the ability to grant a license or sublicense of such Intellectual Property without violating the terms of any agreement or arrangement between HMO and/or Hadasit and any third party. For the avoidance of doubt, no portion of the Controlled IP shall be considered incorporated into, or to form a part of, the Licensed Technology or the Licensed Materials, unless such Controlled IP is specifically so included in a separate agreement executed by the Parties.

 
- 2 -

 

 
1.2.7.
“Consulting Agreement” shall mean a Consulting Agreement between the Company and Hadasit, whereby the Company shall retain, through Hadasit, the services of Prof. Reubinoff and of Dr. Eyal Banin (the "Scientists"), pursuant to which, inter alia, Hadasit will be granted options to purchase three percent (3%) of the Company's fully-diluted equity at the PPS, as of the Date of Amendment, Prof. Reubinoff will be granted options to purchase one-and-one-half percent (1.5%) of the Company's fully-diluted equity at the PPS, as of the Date of Amendment, and Dr. Eyal Banin will be granted options to purchase one-half percent (0.5%) of the Company's fully-diluted equity at the PPS.

 
1.2.8.
"Date of Amendment" shall mean the later of (i) the date on which this Amendment was executed by the Parties and (ii) the date on which all of the Triggering Events have occurred, all subject to Section 13.1.

 
1.2.9.
Distributor shall mean an independent third party with whom there is a bona fide distribution, reseller or similar agreement pursuant to which such third party does not have any rights under or to the Licensed Technology and who purchases Licensed Products in consideration for the purchase price therefor, solely for resale and/or distribution of the Licensed Products in the same form to end-users.

 
1.2.10.
"Effective Date" shall mean the date on which the Original Agreement went into force, i.e. August 30, 2009.

 
1.2.11.
Field” shall mean the development and exploitation of human stem-cell (“hSC”) (such as human embryonic SC (“hESC”) and induced pluripotent hSC (“iPS”) derived retinal pigment epithetlial cells (“hESC-derived RPE Cells” and “hSC-derived RPE Cells”, as the case may be) solely for cell replacement therapy of conditions involving retinal degenerative diseases.

 
1.2.12.
“First Batch Release” shall have the meaning ascribed to such term in Section 2.5(B) below.

 
1.2.13.
Hadasit IP” shall have the meaning ascribed to such term in Section 8.2 below.

 
1.2.14.
“Indemnitees” shall have the meaning ascribed to such term in Section 12 below.