Common use of The Trial Clause in Contracts

The Trial. 6.1 The Company shall supply to the Principal Investigator the Products and/or parts of the Product and/or the materials from which the Product is composed, without consideration, at the necessary pharmaceutical standard, all in accordance with the schedule and in the quantities provided in the Trial Protocol. 6.2 The Trial shall be performed and managed by the Principal Investigator at the Hospital facilities, while making use of the Hospital's resources. 6.3 The Principal Investigator shall carry out the Trial in accordance with the Trial Protocol, GCP, and all the relevant laws and regulations prevailing in Israel and in accordance with all necessary permits and/or licenses from the relevant authorities. 6.4 In performance of the Trial, the Fund shall employ, directly or indirectly, the Trial Personnel, which will comprise the individuals specified in the list appended herewith and marked as Appendix B to this Agreement. 6.5 To avoid any doubt, it is hereby clarified that the Fund and/or the Principal Investigator shall not perform any acts which deviate from the acts specified in the Trial Protocol and/or are specifically mentioned in this Agreement unless the Fund has approved said acts, in advance and in writing. 6.6 Subject to the provisions of Section 13 below, the representatives of the Company shall have the right to examine the results, notes and other documents and representations obtained during the course of the Trial, during regular working hours, after providing advanced written notice and at a reasonable time. To avoid any doubt, it is clarified that this sub-section and any provision of this Agreement shall not be deemed as providing management and/or supervision authority to the Company or to anyone on its behalf over the Trial and/or the Principal Investigator and/or whomever of the Trial Personnel. 6.7 In performance of the Trial, pursuant to this Agreement, the Company undertakes to continue to supply the Product to the Fund and/or the Hospital, without consideration, in order to complete the commenced treatment of the Participants of the Trial at the Principal Investigator’s sole and reasonable discretion, or as part of the Trial Protocol, should one of the Participants of the Trial become dependent on the Product. For avoidance of doubt, it is hereby clarified that this obligation of the Company shall remain in effect even in the event that the Agreement has been terminated or is voided for any reason, but only for so long as it shall be required under the guidelines of the Ministry of Health. 6.8 Notwithstanding the Company's undertakings under this Agreement, the Company undertakes to abide by all the relevant laws and regulations prevailing in Israel and in accordance with and after all necessary permits and/or licenses from the relevant authorities. 6.9 Upon termination of the Trial, the Company shall at its own cost and expense collect all unused Products from Fund at Fund's place of business. In the event the Company shall not collect the Products and/or upon Company's request, the Fund shall destroy the Products and Company shall pay all cost and expenses related to the destruction of Products upon Fund's demand.

The Trial. 6.1 5.1 The Company shall supply to the Principal Investigator the Products and/or parts of the Product and/or the materials from which the Product is composed, without consideration, at the necessary pharmaceutical standard, all in accordance with the schedule and in the quantities provided in the Trial Protocol. 6.2 5.2 The Trial shall be performed and managed by the Principal Investigator at the Hospital facilities, while making use of the Hospital's ’s resources, without payment of further consideration by the Company therefore. 6.3 5.3 The Principal Investigator shall carry out the Trial in accordance with the Trial Protocol, GCP, and all the relevant laws and regulations prevailing in Israel and in accordance with all necessary permits and/or licenses from the relevant authorities. 6.4 5.4 In performance of the Trial, the Fund shall employ, directly or indirectly, the Trial Personnel, which will comprise the individuals specified in the list appended herewith and marked as Appendix B to this Agreement. 6.5 To avoid . In the event that any doubtof the Trial Personnel so identified cease to be available for the Trial, it is hereby clarified that the Fund and/or will use its best efforts to procure within 30 days a substitute of a suitably qualified person acceptable to the Company. The Fund and the Principal Investigator shall not perform represent and warrant that none of the Trial personnel has been debarred, disqualified or banned from conducting clinical studies by any acts which deviate from regulatory agency, including the acts specified Israeli Ministry of Health and the U.S. Food & Drug Administration. In the event that prior to or during the Trial, the Fund or the Principal Investigator become aware that any of the Trial Personnel becomes disbarred, or is in the Trial Protocol and/or are specifically mentioned in this Agreement unless process of disbarment, the Fund has approved said acts, will immediately notify the Company in advance writing and in writingthe Fund will procure within 30 days a substitute of a suitably qualified person acceptable to the Company. 6.6 5.5 Subject to the provisions of Section 13 sub-section 11 below, the representatives of the Company shall have the right to examine the results, notes and other documents and representations obtained during the course of the Trial, during regular working hourshours and confidentially inspect the Principal Investigator’s and the Hospital’s facilities required for performance of the Trial, after providing advanced written notice and at a reasonable time. To avoid any doubt, it is clarified that this sub-section and any provision of this Agreement shall not be deemed as providing management and/or supervision authority to the Company or to anyone on its behalf over the Trial and/or the Principal Investigator and/or whomever of the Trial Personnel. 6.7 5.6 In performance of the Trial, pursuant to this Agreement, the Company undertakes to continue to supply the Product to the Fund and/or the Hospital, without consideration, in order to complete the commenced treatment of the Participants of the Trial at the Principal Investigator’s sole and reasonable discretion, or as part of the Trial Protocol, should one of the Participants of the Trial become dependent on the Product. For avoidance of To avoid any doubt, it is hereby clarified that this obligation of the Company shall remain in effect even in the event that the Agreement has been terminated or is voided for any reason, but only for so long as it shall be required under the guidelines of the Ministry of Health. 6.8 5.7 Notwithstanding the Company's ’s undertakings under this Agreement, the Company undertakes to abide by all the relevant laws and regulations prevailing in Israel and in accordance with and after all necessary permits and/or licenses from the relevant authorities, as are presented to it by the Fund. 6.9 Upon termination of the Trial, the Company shall at its own cost and expense collect all unused Products from Fund at Fund's place of business. In the event the Company shall not collect the Products and/or upon Company's request, the Fund shall destroy the Products and Company shall pay all cost and expenses related to the destruction of Products upon Fund's demand.

The Trial. 6.1 5.1 The Company shall supply to the Principal Investigator the Products and/or parts of the Product and/or the materials from which the Product is composed, without consideration, at the necessary pharmaceutical standard, all in accordance with the schedule Trial Protocol and in the quantities provided in the Trial Protocol. 6.2 5.2 The Trial shall be performed by the Trial Personnel and managed by the Principal Investigator at the Hospital facilities, while making use of the Hospital's resources. 6.3 5.3 The Principal Investigator shall carry out the Trial in accordance with this Agreement, the Trial Protocol, GCP, and all the relevant laws and regulations prevailing in Israel and in accordance with all necessary permits and/or licenses from the relevant authorities. 6.4 5.4 In performance of the Trial, the Fund shall employ, directly or indirectly, the Trial Personnel, which will comprise the individuals specified in the list appended herewith and marked as Appendix B to this Agreement. 6.5 To avoid any doubt, it is hereby clarified that the Fund and/or the Principal Investigator shall not perform any acts which deviate from the acts specified in the Trial Protocol and/or are specifically mentioned in this Agreement unless the Fund has approved said acts, in advance and in writing. 6.6 5.5 Subject to the provisions of Section 13 sub-section 11 below, the representatives of the Company shall have the right to examine examine, study, make copies of and exploit in any other manner as they shall see fit the results, notes and other documents and representations obtained during the course of the Trial, during regular working hours, after providing advanced written notice and at a reasonable time. To avoid any doubt, it is clarified that this sub-section and any provision of this Agreement shall not be deemed as providing management and/or supervision authority to the Company or to anyone on its behalf over the Trial and/or the Principal Investigator and/or whomever of the Trial Personnel. 6.7 5.6 In performance of the Trial, pursuant to this Agreement, the Company undertakes to continue to supply the Product to the Fund and/or the Hospital, without consideration, in order to complete the commenced treatment of the Participants of the Trial at the Principal Investigator’s sole and reasonable discretion, or as part of the Trial Protocol, should one of the Participants of the Trial become dependent on the Product. For avoidance of To avoid any doubt, it is hereby clarified that this obligation of the Company shall remain in effect even in the event that the Agreement has been terminated or is voided for any reason, but only for so long as it shall be required under the guidelines of the Ministry of Health. 6.8 5.7 Notwithstanding the Company's undertakings under this Agreement, the Company undertakes to abide by all the relevant laws and regulations prevailing in Israel and in accordance with and after all necessary permits and/or licenses from the relevant authorities. 6.9 5.8 Without derogating from the generality of the foregoing, the Parties shall perform the Trial in accordance with the terms specified in the Israeli MOH Guidelines titled “Clinical Trials of Human Subjects” issued on February 2016 (hereinafter referred to as "Ministry Guidelines") including without limitation Appendix 4 and Appendix 5 to the Ministry Guidelines titled “Warrants of the Sponsor", that will be attached to this Agreement as Appendix D and serve as an integral part of this Agreement 5.9 The Parties represent that they will monitor and evaluate all applicable safety procedures in the performance of the Trial, and ensure the good quality of the Trial performance and/or products and/or equipment (including the Product) used in the Trial, each according to its role under this Agreement. This requirement shall not derogate from the Parties commitment to perform the Trial in accordance with all ethical requirements applicable to clinical trials. 5.10 The Company is responsible to ensure that the research methods and processes of the Trial are safe and ethical, and the Company shall use trained and qualified research teams in connection with the Trial. Furthermore, the Company shall ensure that the data provided is reliable and valid and that all the results and/or reports made by the Company shall be statistically accurate, ethical and unbiased. 5.11 Without derogating from the above, the Parties hereby undertake to keep in confidence, not to transfer to any person and/or entity and not to make any use of any individually identifiable health information in a way that would prejudice a patient's privacy whether or not he/she ultimately participates in the Trial. This obligation shall survive any termination or expiration of this Agreement indefinitely. For avoidance of doubt, patient medical records shall remain the exclusive property of the Fund. 5.12 Upon termination of the TrialTrial and promptly upon Fund's written request, the Company shall at its own cost and expense collect all unused Products from Fund at Fund's place of business. In the event the Company shall not collect the Products and/or upon Company's request, the Fund shall destroy the Products and Company shall pay all cost and expenses related to the destruction of Products upon Fund's demand.