AGREEMENT Between BioCancell Therapeutics Ltd. Beck Science Center, 8 Hartom St. Jerusalem 97775, Israel (Hereinafter: “BioCancell”) And between The Fund for Medical Research, Development of Infrastructure and Health Services (Hereinafter: “the Fund”)...

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1.	Terms and Definitions

2.	The Consideration

2.1.

In consideration for the performance, in good faith, by the Principal Investigator and the Fund, of all of their undertakings under this Agreement, BioCancell hereby undertakes to pay to the Fund the following amounts:

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3.	Limitation of Payments

3.1.

For the avoidance of doubt, it is hereby declared and agreed that BioCancell shall not pay any additional payments or any other amounts, which are not clearly mentioned and specified in section 2 above.

3.2.

It is further clarified that the amounts specified in section 2 above include payment by BioCancell for all services rendered from the Fund including but not limited to office services. Trial Personal required for performing the Trial including the Principal Investigator, physicians, nurses, receptionists and study coordinator, use of the Fund’s facilities, and all tests, procedures, examinations and evaluations as detailed in the Trial protocol.

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3.3.

The considerations do not include cost of analysis of hematology and chemistry samples which will be performed by BioCancell’s sub-contractor/s.

4.1.

The Fund shall send an invoice at the end of each calendar quarter (31/3, 30/6, 30/9, and 31/12) detailing the Complete Screening, Complete Treatment Visits and Complete Evaluation Visits (together hereinafter: “Complete Visits”) performed as well as on which Subjects or Participating Subjects the relevant Complete Visit was performed.

4.2.

Payments detailed in section 2 shall be conditioned upon payment for Complete Visits and shall be included in the first invoice sent by the Fund.

4.3.

Payment shall be maid by BioCancell within 30 (thirty) days of receipt of the Fund’s invoice.

4.4.

All Payments shall be performed in the last day of the calendar year during which the relevant payment date occurred. (Occurrence of the relevant payment date shall be at the termination and completion of the stage and conditions of which entitles the Fund for payment according to this Appendix C).

4.5.

Immediately upon receiving the payment as per the issued invoice the Fund will provide BioCancell with a receipt approving the payment.

6.1.

No payment would be performed for any activities performed by the Principal Investigator and/or by the Fund, prior to the commencement of the Trial.

6.2.

Without derogating from any right of BioCancell, in the event that no Completed CRF’s are provided to BioCancell, regarding a Subject, in relation to which BioCancell has performed payments to the Fund, BioCancell Shall be entitled to perform one of the following three, according to its absolute discretion:

6.2.1.

Write-off the amount paid by BioCancell in relation to Subject(s) for which no Completed CRFs have been provided (hereinafter: “the Return Amount”) from the amount remaining due to the Fund by BioCancell according to this Agreement (hereinafter: “the Remaining Amount”).

6.2.2.

Order the Fund, in writing, to pay BioCancell the Return Amount within a period no longer than 45 (forty-five) days from the End of the Trial. The Fund hereby undertakes that it shall pay the Return Amount, as specified above, and renounces any contentions and/or claims whatsoever in relation thereto.

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6.2.3.

In the event that the Return Amount shall exceed the Remaining Amount, BioCancell shall be entitled to exercise its rights under the above sub-sections 6.3.1 and 6.3.2 in concert, to the extent that BioCancell shall fully collect the Return Amount from the Fund.

6.3.

No advance payments would be performed by BioCancell to the Fund.

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1.	Sponsor undertaking

1.1.1.

Responsibility for the safety and good order of the investigational product;

1.1.2.

Supply of information regarding the trial;

1.1.3.

Notice to the Ministry of Health regarding the performance of a multicentre trial in Israel;

1.1.4.

Monitoring the trial process;

1.1.5.

Safety reports;

1.1.6.

Accountability in respect of the investigational product;

1.1.7.

Retention of documents.

2.	The Sponsor undertakes that if it shall decide to publish the results of the clinical trial in scientific literature, it shall publish them in full and without taking matters out of their context.

3.	Insurance:

3.1.

The Sponsor undertakes to insure its legal liability pursuant to the laws of the State of Israel against claims that, may be filed by subjects in the clinical trial and/or third party claims - all in connection with the clinical trial, whether in the period of conducting the clinical trial or thereafter. The insurance shall be extended to include the legal liability of the medical institution and/or the clinical trial personnel and/or the Principal Investigator (hereinafter referred to as “the parties conducting the trial”) deriving from their involvement in the conduct of the clinical trial, subject to an exception of an act committed negligently or an intentional deviation from the clinical trial protocol.

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3.2.

The Sponsor shall be given notice of any claim or any potential claim immediately after such comes to the knowledge of the medical institution or the Principal Investigator.

3.3.

The Principal Investigator, the medical institution and its employees shall give the Sponsor, upon its written request, reasonable support in any event of a claim that may be filed against it as aforesaid.

4.

The Sponsor undertakes to supply the medical institution with the investigational product throughout the period of the clinical trial until the conclusion thereof, free of charge. Furthermore, the Sponsor undertakes to pay all additional costs deriving from the conduct of the clinical trial, provided that such costs do not derive from the regular medical treatment of the sickness.

5.

If after the termination of the clinical trial it is ascertained and recommended by the Principal Investigator that the welfare of the patient participating in the clinical trial necessitates continuation of his treatment with the investigational product and there is no other appropriate alternative medical treatment, the Sponsor undertakes to also continue supplying the investigational product, without charge, after the termination of the clinical trial for a period of three years, except in one of the following cases:

5.1.

The investigational product was approved for marketing in the State of Israel after its registration for its requested scope and it can be obtained from the sick fund with which the patient is insured.

5.2.

The development of the product was discontinued or the results of the clinical trials were unsuccessful.

5.3.

The administration of the investigational product for the said protracted period is likely to harm the patient’s health, since there is insufficient information regarding the safety of the product administered over the long term.

5.4.

Where the investigational product is not a medical preparation, such as: cosmetic products / food / food additive / herbal remedy.

6.	The continued administration of the investigational product after termination of the clinical trial is subject to the following terms and conditions:

6.1.

The continued treatment shall be given within the context of an orderly monitoring protocol that shall be written by the Principal Investigator and approved by the Sponsor and the Helsinki Committee.

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6.2.

The Principal Investigator is responsible for continuing to routinely monitor the subject’s medical condition and to report to the Helsinki Committee any exceptional events that occur during the ongoing treatment, as is the norm in clinical trials.

7.	This Appendix constitutes an integral part of the agreement between the company sponsoring the clinical trial and the medical institution.

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1.	The executed signature page of the Trial Protocol; and

2.	Investigator Brochure; and

3.	The current curriculum vitae of the Principal Investigator; and

4.	The list of all sub-investigators, all of which necessarily being listed on either the FDA form no. 1572, or on the Principal Investigator’s Statement Form; and

5.	The written approval of the Fund Helsinki Committee, indicating that it has reviewed and approved the Trial Protocol; and

6.	The written approval of the MOH with regards to the content of all publicity and advertisements, related to the Trial, which are to be performed prior to the commencement of the Trial; and

7.	A list of all participants in the Helsinki Committee, convened in relation to the Trial (hereinafter: “the Helsinki Committee”); and

7.1.

Should the Principal Investigator be a member of the Helsinki Committee, the written Statement of the chairman of the Helsinki Committee confirming that the Principal Investigator did not participate in the voting, relating to the Trial, during the hearing of the said Helsinki Committee; and

7.2.

A financial disclosure form, confirming that the Principal Investigator holds no financial interests in BioCancell.

1.	A review of all the Trial Documents and verification the accuracy and completeness thereof in relation to the source documents, on which the above documents were based; and

2.	Report to the Fund Helsinki Committee of any Severe Adverse Events, as such terms are defined in the Trial Protocol, to the Subject(s), in accordance with the Guidelines; and

3.	Report to the Fund Helsinki Committee of any deviation from the Trial Protocol; and

4.

Maintain adequate records of Subjects identification, clinical observations, as well as study drug receipt and dispensation (hereinafter: “the Records”), in accordance with any applicable laws, rules, regulations and guidelines, as amended from time to time. In any event, the Principal Investigator and BioCancell shall maintain the Records for a period of no less than 15 (fifteen) years following the end of the Trial.

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5.	Compare the data in the CRF with the source documents relating to each subject participating in the Trial, and confirm the accuracy of the CRF; and

6.	Maintain a log, documenting the Product(s) provided to each subject during the Trial; and

7.	Report no later than 7 (seven) days before additional quantities of Product(s) are required to proceed with the Trial.

8.	Complete all CRFs

9.	Re-validate the approval of the relevant Helsinki Committee to the Trial, within a reasonable time prior to its expiration date.

10.	A written detailed periodic report on the progress of the Trial in the said period (section 17.3 of the Agreement).

1.	All Completed CRFs;

2.	A summary report, which shall include, in a full and detailed manner, a declaration regarding the activities performed during the Trial and the results obtained therein (section 17.4 of the Agreement).