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CLINICAL TRIAL AGREEMENT

 

This agreement (hereinafter: “Agreement”) is entered into as of February 17, 2010 (hereinafter: the “Effective Date”) by and between Hadasit Medical Research Services and Development Ltd., a company duly incorporated under the laws of Israel I.D. No. 51-115685-3, from Jerusalem Bio-Park, Hadassah Ein-Kerem Medical Center, P.O.Box 12000, Jerusalem 91120, (hereinafter: “ Hadasit ” or the “ Institution ”) and Prof. Dimitrios Karousis (the “ Investigator ”) on one hand and BrainStorm Cell Therapeutics Ltd., a corporation organized under the laws of Israel I.D. No. 51-360102-1, with its registered office located at 12 Basel Street, Petah-Tikva 49001, in this matter duly represented by Rami Efrati, (hereinafter: “ Sponsor ”) , on the other hand.

 

PREAMBLE

1

1.

STUDY, INVESTIGATOR AND SITE

2

2.

COMPLIANCE WITH LAWS, REGULATIONS AND GUIDELINES

3

3.

INFORMED CONSENT

3

4.

RECORDKEEPING, REPORTING AND ACCESS

3

5.

COMPENSATION FOR STUDY

4

6.

CONFIDENTIAL INFORMATION

5

7.

PUBLICATIONS

6

8.

INTELLECTUAL PROPERTY

7

9.

TANGIBLE MATERIALS

8

10.

INDEMNIFICATION, INSURANCE, LIMITED LIABILITIES

8

11.

TERM AND TERMINATION

11

12.

CHANGES TO THE PROTOCOL

12

13,

ASSIGNMENTS

12

14.

APPLICABLE LAW

12

15.

INDEPENDENT CONTRACTORS

12

16.

NOTICES

12

17.

ENTIRE AGREEMENT

13

Schedule A - Protocol

15

Schedule B - GMP Agreement

16

Schedule C - Consideration

17

 

PREAMBLE

 

WHEREAS Hadasit is a wholly owned subsidiary of Hadassah Medical Organization (“ HMO ”) and is authorized to enter this Agreement and to utilize HMO’s facilities, employees and agents for purpose of this Agreement;

 

WHEREAS Sponsor is a wholly owned subsidiary of Brainstorm Cell Therapeutics Inc., a Delaware corporation SEC file number 333-61610, with its registered office located at 110 east 59 th Street, New York, NY United States of America (hereinafter: “Brainstorm Inc.”).

 

WHEREAS the Sponsor is in the process of development of innovative adult stem cell therapies using its unique cells method for highly debilitating neurodegenerative disorders such as Amyotrophic Lateral Sclerosis (ALS) Parkinson’s Disease (PD) and multiple sclerosis (hereinafter: the “ Product ”) and has prepared the Protocol in order to conduct clinical trials for further investigation of the Product.

 

 

 


 

 

WHEREAS the Sponsor represents that it is the sole owner of and/or has the right to use any and all intellectual property rights in the Product and the Protocol (as such term is defined herein), and that the execution and delivery of this Agreement dose not infringe any third parties’ rights and/or any applicable law;

 

WHEREAS, the SPONSOR is willing to invest certain funds in the Study (as hereinafter defined) to be carried at HMO’s facilities by the Investigator under the terms and conditions herein;

 

NOW THEREFORE, the parties agree as follows:

 

1.

STUDY, INVESTIGATOR AND SITE

 

 

A.

Hadasit shall contribute the Investigator for purpose of carrying out a clinical trial (the: “ Study ”) in accordance with the Sponsor Protocol titled “Explorative clinical trial to evaluate the safety and tolerability of injection of mesenchymal bone marrow stem cells secreting neurotrophic factors (MSC- NTF), in patients with amyotrophic lateral sclerosis (ALS)” (the “ Protocol ”), which has been drafted jointly by the Sponsor and the Investigator. A copy of the Protocol is attached herein as Schedule A .

 

The Investigator will be responsible for performing the Study and for the direct supervision of any individual performing portions of the Study.

 

 

B.

In the event that the Investigator ceases to be available for purpose of the Study (including without limitation the event of termination of employment between HMO and the investigator for any reason whatsoever), Hadasit shall use its best efforts to procure within 30 days his/her substitution by a suitably qualified person acceptable to Sponsor. If such substitute is not acceptable to the Sponsor, Sponsor shall be entitled to terminate this Agreement without further notice, and this shall be Sponsor’s sole remedy in such circumstances.

 

 

C.

Notwithstanding anything to the contrary herein, the Sponsor hereby represents and warrants that it has examined the facilities of the Institution and found them entirely adequate and suitable for the purpose of performance of the Protocol and the Study. In addition, nothing contained herein shall be construed as casting upon the Institution, the Investigator or HMO an undertaking to purchase any special equipment for purpose of the Study or to improve its existing equipment.

 

 

D.

The Product used in the Study shall be processed in a class 10,000 laboratory in Hadassah National Facility operated according to GMP Standards under the Agreement attached hereto as Schedule B .

 

 

2


 

 

2.

COMPLIANCE WITH LAWS, REGULATIONS AND GUIDELINES

 

governing the performance of clinical studies and (iii) with all applicable standards, regulations or guidelines for good clinical practice (“ GCP ”) and ethical conduct in connection with clinical studies, including those of the Institution and HMO.

 

 

B.

Prior to commencement of the Study, the Investigator will seek at the Sponsor’s expense any consents or approvals that must be obtained from the HMO’s ethics committee (the “ Committee ”). The Investigator will comply with all requirements established by the Committee and agrees to execute such assurances and other documents as the Committee may reasonably request. The Sponsor shall assist the Investigator to the extent required in this regard including, without limitation, signing the relevant forms and amending the Sponsor’s documents which shall be filed with the Committee. The Investigator will not enroll patients in the Study until the Protocol has been reviewed and approved by the Committee. The Sponsor shall be liable to obtain any further approval that may be required under applicable law. Any delay in the performance by the Institution and/or the Investigator’s of any of their undertakings hereunder due to insufficient approvals shall not be deemed to be a breach of this Agreement by them.

 

3.

INFORMED CONSENT

 

 

A.

The Investigator will be responsible for obtaining the written informed consent of each subject participating in the Study (or his or her authorized legal representative) before his or her participation in the Study. The form that shall be used in this regard shall be drafted by the Investigator and approved by the Sponsor, however the Investigator shall be responsible for its content.

 

 

B.

Without derogating from the generality of the aforementioned, the parties agree that such informed consent shall be granted only under circumstances that provide the prospective Study subject (or his or her representative) with sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The parties further agree that any such written informed consent shall be obtained in compliance with all applicable laws, regulations, standards or guidelines.

 

4.

RECORDKEEPING, REPORTING AND ACCESS

 

 

A.

ACCESS. The Sponsor and/or any regulatory authorities may, to the extent reasonably necessary or to the extent required by applicable laws, regulations, standards or guidelines, subject to prior coordination with the Investigator and at the normal working hours in HMO (i.e. 8:00AM-16:00 PM):

 

 

(1)

examine and inspect the Investigator’s and the Institution’s facilities required for performance of the Study; and

 

 

3


 

 

 

(2)

confidentially inspect all data and work product relating to the Study.

 

 

(3)

Notwithstanding anything to the contrary herein, any information and/or data to be provided to the Sponsor under Sub Sections 1-2 above or under any other provision hereunder, shall be subject to the provisions of section 6(D) below and to the rights of the Subject of the Study for medical confidentiality and privacy under any applicable law or regulation (including, without limitation, HMO’s internal procedures).

 

 

B.

The Investigator shall prepare and maintain reasonably complete and accurate wri


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