Common use of Quality Assurance and Control Clause in Contracts

Quality Assurance and Control. 6.1. The Site Parties shall ensure that all procedures defined in the Protocol are complied with, so that all data generated at the Trial Site are reliable and have been processed correctly (especially the randomization lists, and the blind character of the Clinical Trial as the case may be) and will ensure that the content of the CRFs or e-CRFs will accurately reflect source documents. 6.2. The Site Parties will permit the Sponsor to examine the conduct of the Clinical Trial and the Trial Site upon reasonable advance notice and in the company of a Site Party’s representative, during regular business hours at mutually agreed times, and at Sponsor's sole expense to determine that the Clinical Trial is being conducted in accordance with the Protocol, this Agreement and applicable Law, provided Trial Monitor will comply with all internal policies and regulations of the Trial Site. 6.3. The Site Parties shall permit the Trial Monitor and any Auditor access to all relevant clinical data of Clinical Trial Subjects for monitoring of the progress of the Clinical Trial, the proper collection and recording of Clinical Trial data, the welfare of the Clinical Trial Subjects, and altogether the good quality of the Clinical Trial and compliance with applicable Law and Sponsor’s and/or CRO’s Standard Operating Procedures. For the avoidance of any doubt, the Sponsor shall be responsible for the confidential handling of all personal data of Study Subjects and other patients which the Trial Monitor and any Auditor comes across with during its monitoring or auditing activities. 6.4. The Site Parties shall promptly inform the Sponsor and/or CRO of any intended or actual inspection, written enquiry and/or visit to the Trial Site by any regulatory authority in connection with the Clinical Trial and forward to the Sponsor copies of any correspondence from any such regulatory authority relating to the Clinical Trial. The Site Parties shall allow Sponsor and/or CRO representatives to be present during any such visit as permitted by Law. 6.5. The Site Parties shall permit authorized representatives of the Ethics Committee and Competent Authorities to have access to, copy and verify information relating to the Clinical Trial, as required by and in accordance with applicable Law. Furthermore Sponsor and/or CRO acknowledges and agrees that the Institution executive management (or a local review board appointed by such management) will have the right to audit the performance of the Clinical Trial at the Trial Site. Institution acknowledges that the Clinical Trial is subject to inspection by regulatory authorities worldwide and that such inspections may occur after the completion of the Clinical Trial. 6.6. In the event that the Sponsor and /or CRO reasonably believes there has been any research misconduct in relation to the Clinical Trial, Site Parties shall provide all reasonable assistance to any investigation into any alleged research misconduct undertaken by or on behalf of the Sponsor and/or CRO, the results of which the Party on whose behalf the investigation was undertaken shall, subject to any obligations of confidentiality, communicate to the Principal Investigator. In the event that the Principal Investigator reasonably believes there has been any research misconduct in relation to the Clinical Trial, the Sponsor shall provide all reasonable assistance to any investigation undertaken by or on behalf of the Principal Investigator, the results of which shall, subject to any obligations of confidentiality, be communicated to the Sponsor.The Site Parties shall take appropriate measures and cause the Research Staff to take appropriate measures and corrective actions without delay as the Sponsor and/or CRO may reasonably require in order to solve all problems found and reported by the Trial Monitors and any of the aforesaid Auditors, or representatives of the Ethics Committee, Competent Authority or other regulatory authority. 6.7. It is expressly agreed between the Parties that (a) the Sponsor will not compensate the Principal Investigator nor any member of the Research Staff for the assistance or guidance of representatives of the Ethics Committee, Competent Authority or other regulatory authority and (b) the assistance or guidance of Trial Monitors or Sponsor’s Auditors by the Principal Investigator and the Research Staff shall be deemed included in the remuneration paid pursuant to clause 13 hereinafter unless expressly agreed otherwise in writing. 6.8. The Principal Investigator and any member of the Research Staff will be trained by Sponsor with respect to the use of eCRFs. Before the training process, the Principal Investigator and each member of the Research Staff shall sign an acknowledgment agreement which shall contain statements of understanding and acceptance of their obligations regarding the eCRF process.

Quality Assurance and Control. 6.1. The Site Parties shall ensure that all procedures defined in the Protocol are complied with, so that all data generated at the Trial Site are reliable and have been processed correctly (especially the randomization lists, and the blind character of the Clinical Trial as the case may be) and will ensure that the content of the CRFs or e-CRFs will accurately reflect source documents. 6.2. The Site Parties will permit the Sponsor Company to examine the conduct of the Clinical Trial and the Trial Site upon reasonable thirty (30) days advance written notice and in the company of a Site Party’s representative, during regular business hours at mutually agreed times, and at Sponsor's Company’s sole expense to determine that the Clinical Trial is being conducted in accordance with the Protocol, this Agreement and applicable Law. If the audit is not-for-cause, provided Trial Monitor will comply with all internal policies and regulations Company shall compensate Sponsor for their help during the audit at a rate of the Trial Siteone-thousand five-hundred euro per day (1,500€/day). 6.3. The Site Parties acknowledge that Sponsor shall permit the Trial Monitor Study Monitor, Auditor and any Auditor official with a legal right to inspect and access to all relevant clinical documentation and source data of Clinical Trial Subjects for monitoring of the progress of the Clinical Trial, the proper collection and recording of Clinical Trial dataStudy Data, the welfare of the Clinical Trial Subjects, and altogether the good quality of the Clinical Trial and compliance with applicable Law and, if applicable and communicated to the Site Parties in writing, Sponsor’s and/or CRO’s Standard Operating Proceduresstandard operating procedures. For the avoidance of any doubt, the Sponsor shall be responsible for the confidential handling of all personal data Personal Data of Study Clinical Trial Subjects and other patients patients, which the Trial Monitor and any Auditor comes across with during its monitoring or auditing activities. 6.4. The Site Parties shall promptly inform the Sponsor and/or CRO of any intended or actual inspection, written enquiry and/or visit to the Trial Site by any regulatory authority in connection with the Clinical Trial and forward to the Sponsor copies of any correspondence from any such regulatory authority relating to the Clinical Trial. The Site Parties shall allow Sponsor and/or CRO representatives to be present during any such visit as permitted by Law. 6.5. The Site Parties shall permit authorized representatives of the Ethics Committee and Competent Authorities to have access to, copy and verify information relating to the Clinical Trial, as required by and in accordance with applicable Law. Furthermore Sponsor and/or CRO Company acknowledges and agrees that the Institution Sponsor executive management (or a local review board appointed by such management) will have the right to audit the performance of the Clinical Trial at the Trial Site. Institution acknowledges Parties acknowledge that the Clinical Trial is subject to inspection by regulatory authorities worldwide and that such inspections may occur after the completion of the Clinical Trial. 6.6. In the event that the Sponsor and /or CRO reasonably believes there has been any research misconduct in relation to the Clinical Trial, Site Parties shall provide all reasonable assistance to any investigation into any alleged research misconduct undertaken by or on behalf of the Sponsor and/or CRO, the results of which the Party on whose behalf the investigation was undertaken shall, subject to any obligations of confidentiality, communicate to the Principal Investigator. In the event that the Principal Investigator reasonably believes there has been any research misconduct in relation to the Clinical Trial, the Sponsor shall provide all reasonable assistance to any investigation undertaken by or on behalf of the Principal Investigator, the results of which shall, subject to any obligations of confidentiality, be communicated to the Sponsor.The Site Parties shall take appropriate measures and cause the Research Staff to take appropriate measures and corrective actions without delay as the Sponsor and/or CRO may reasonably require in order to solve all problems found and reported by the Trial Monitors and any of the aforesaid Auditors, or representatives of the Ethics Committee, Competent Authority or other regulatory authority. 6.7. It is expressly agreed between the Parties that (a) the Sponsor will not compensate the Principal Investigator nor any member of the Research Staff for the assistance or guidance of representatives of the Ethics Committee, Competent Authority or other regulatory authority and (b) the assistance or guidance of Trial Monitors or Sponsor’s Auditors by the Principal Investigator and the Research Staff shall be deemed included in the remuneration paid pursuant to clause 13 hereinafter unless expressly agreed otherwise in writing. 6.8. The Principal Investigator and any member of the Research Staff will be trained by Sponsor with respect to the use of eCRFs. Before the training process, the Principal Investigator and each member of the Research Staff shall sign an acknowledgment agreement which shall contain statements of understanding and acceptance of their obligations regarding the eCRF process.

Quality Assurance and Control. 6.1. The Site Parties shall ensure that all procedures defined in the Protocol are complied with, so that all data generated at the Trial Site are reliable and have been processed correctly (especially the randomization lists, and the blind character of the Clinical Trial as the case may be) and will ensure that the content of the CRFs or e-CRFs will accurately reflect source documents. 6.2. The Site Parties will permit the Sponsor to examine the conduct of the Clinical Trial and the Trial Site upon reasonable advance notice and in the company of a Site Party’s representative, during regular business hours at mutually agreed times, and at Sponsor's sole expense to determine that the Clinical Trial is being conducted in accordance with the Protocol, this Agreement and applicable Law, provided Trial Monitor will comply with all internal policies and regulations of the Trial Site. 6.3. The Site Parties shall permit the Trial Monitor and any Auditor access to all relevant clinical data of Clinical Trial Subjects for monitoring of the progress of the Clinical Trial, the proper collection and recording of Clinical Trial data, the welfare of the Clinical Trial Subjects, and altogether the good quality of the Clinical Trial and compliance with applicable Law and Sponsor’s and/or CRO’s Standard Operating Procedures. For the avoidance of any doubt, the Sponsor shall be responsible for the confidential handling of all personal data of Study Subjects and other patients which the Trial Monitor and any Auditor comes across with during its monitoring or auditing activities. 6.4. The Site Parties shall promptly inform the Sponsor and/or CRO of any intended or actual inspection, written enquiry and/or visit to the Trial Site by any regulatory authority in connection with the Clinical Trial and forward to the Sponsor copies of any correspondence from any such regulatory authority relating to the Clinical Trial. The Site Parties shall allow Sponsor and/or CRO representatives to be present during any such visit as permitted by Law. 6.5. The Site Parties shall permit authorized representatives of the Ethics Committee and Competent Authorities to have access to, copy and verify information relating to the Clinical Trial, as required by and in accordance with applicable Law. Furthermore Sponsor and/or CRO acknowledges and agrees that the Institution executive management (or a local review board appointed by such management) will have the right to audit the performance of the Clinical Trial at the Trial Site. Institution acknowledges that the Clinical Trial is subject to inspection by regulatory authorities worldwide and that such inspections may occur after the completion of the Clinical Trial. 6.6. In the event that the Sponsor and /or CRO reasonably believes there has been any research misconduct in relation to the Clinical Trial, Site Parties shall provide all reasonable assistance to any investigation into any alleged research misconduct undertaken by or on behalf of the Sponsor and/or CRO, the results of which the Party on whose behalf the investigation was undertaken shall, subject to any obligations of confidentiality, communicate to the Principal Investigator. In the event that the Principal Investigator reasonably believes there has been any research misconduct in relation to the Clinical Trial, the Sponsor shall provide all reasonable assistance to any investigation undertaken by or on behalf of the Principal Investigator, the results of which shall, subject to any obligations of confidentiality, be communicated to the Sponsor.The Site Parties shall take appropriate measures and cause the Research Staff to take appropriate measures and corrective actions without delay as the Sponsor and/or CRO may reasonably require in order to solve all problems found and reported by the Trial Monitors and any of the aforesaid Auditors, or representatives of the Ethics Committee, Competent Authority or other regulatory authority. 6.7. It is expressly agreed between the Parties that (a) that a. the Sponsor will not compensate the Principal Investigator nor any member of the Research Staff for the assistance or guidance of representatives of the Ethics Committee, Competent Authority or other regulatory authority and (b) and b. the assistance or guidance of Trial Monitors or Sponsor’s Auditors by the Principal Investigator and the Research Staff shall be deemed included in the remuneration paid pursuant to clause 13 hereinafter unless expressly agreed otherwise in writing. 6.8. The Principal Investigator and any member of the Research Staff will be trained by Sponsor with respect to the use of eCRFs. Before the training process, the Principal Investigator and each member of the Research Staff shall sign an acknowledgment agreement which shall contain statements of understanding and acceptance of their obligations regarding the eCRF process.

Quality Assurance and Control. 6.1. The Site Parties shall ensure that all procedures defined in the Protocol are complied with, so that all data generated at the Trial Site are reliable and have been processed correctly (especially the randomization lists, and the blind character of the Clinical Trial as the case may be) and will ensure that the content of the CRFs or e-CRFs will accurately reflect source documents. 6.2. The Site Parties will permit the Sponsor to examine the conduct of the Clinical Trial and the Trial Site upon reasonable advance notice and in the company of a Site Party’s representative, during regular business hours at mutually agreed times, and at Sponsor's sole expense to determine that the Clinical Trial is being conducted in accordance with the Protocol, this Agreement and applicable Law, provided Trial Monitor will comply with all internal policies and regulations of the Trial SiteSite to the extent these are sufficiently communicated to the Trial Monitor. 6.3. The Site Parties shall permit the Trial Monitor and any Auditor access to all relevant clinical data of Clinical Trial Subjects and relevant source documents for monitoring of the progress of the Clinical Trial, the proper collection and recording of Clinical Trial data, the welfare of the Clinical Trial Subjects, and altogether the good quality of the Clinical Trial and compliance with applicable Law and Sponsor’s and/or CRO’s Standard Operating Procedures. For the avoidance of any doubt, the Sponsor shall be responsible for the confidential handling of all personal data Personal Data of Study Clinical Trial Subjects and other patients which the Trial Monitor and any Auditor comes across with during its monitoring or auditing activities. Before the start of the monitoring visits, the Sponsor shall provide the Institution with the name and date of birth of the appointed monitor, and declare that such Trial Monitor has signed a confidentiality statement regarding the above. 6.4. The Site Parties shall promptly inform the Sponsor and/or CRO of any intended or actual inspection, written enquiry and/or visit to the Trial Site by any regulatory authority in connection with the Clinical Trial and forward to the Sponsor copies of any correspondence from any such regulatory authority relating to the Clinical Trial. The Site Parties shall allow Sponsor and/or CRO representatives to be present during any such visit as permitted by Law. 6.5. The Site Parties shall permit authorized representatives of the Ethics Committee and Competent Authorities to have access to, copy and verify information relating to the Clinical Trial, as required by and in accordance with applicable Law. Furthermore Sponsor and/or CRO acknowledges and agrees that the Institution executive management (or a local review board appointed by such management) will have the right to audit the performance of the Clinical Trial at the Trial Site. Institution acknowledges Parties acknowledge that the Clinical Trial is subject to inspection by regulatory authorities worldwide and that such inspections may occur after the completion of the Clinical Trial. 6.6. In the event that the Sponsor and /or CRO reasonably believes there has been any research misconduct in relation to the Clinical Trial, Site Parties shall provide all reasonable assistance to any investigation into any alleged research misconduct undertaken by or on behalf of the Sponsor and/or CRO, the results of which the Party on whose behalf the investigation was undertaken shall, subject to any obligations of confidentiality, communicate to the Principal Investigator. In the event that the Principal Investigator reasonably believes there has been any research misconduct in relation to the Clinical Trial, the Sponsor shall provide all reasonable assistance to any investigation undertaken by or on behalf of the Principal Investigator, the results of which shall, subject to any obligations of confidentiality, be communicated to the Sponsor.. The Site Parties shall take appropriate measures and cause the Research Staff to take appropriate measures and corrective actions without delay as the Sponsor and/or CRO may reasonably require in order to solve all problems found and reported by the Trial Monitors and any of the aforesaid Auditors, or representatives of the Ethics Committee, Competent Authority or other regulatory authority. 6.7. It is expressly agreed between the Parties that (a) that a. the Sponsor will not compensate the Principal Investigator nor any member of the Research Staff for the assistance or guidance of representatives of the Ethics Committee, Competent Authority or other regulatory authority and (b) and b. the assistance or guidance of Trial Monitors or Sponsor’s Auditors by the Principal Investigator and the Research Staff shall be deemed included in the remuneration paid pursuant to clause 13 hereinafter unless expressly agreed otherwise in writing. 6.8. The Principal Investigator and any member of the Research Staff will be trained by Sponsor with respect to the use of eCRFs. Before the training process, the Principal Investigator and each member of the Research Staff shall sign an acknowledgment agreement which shall contain statements of understanding and acceptance of their obligations regarding the eCRF process.