Common use of Quality Assurance and Control Clause in Contracts

Quality Assurance and Control. The Site Parties shall permit the Study Monitor, Auditor and any official with a legal right to inspect and access all relevant documentation and source data for monitoring of the progress of the Clinical Study, the proper collection and recording of Clinical Study data, the welfare of the Clinical Study Subjects, and altogether the good quality of the Clinical Study and compliance with applicable Law and, if applicable and communicated to the Site Parties in writing, Sponsor’s standard operating procedures. The Study Monitor and Auditor’s access will be arranged at mutually convenient times and on reasonable notice with no additional costs for the Study Monitor, Auditor or Sponsor. The Study Monitor and Auditor will comply with all internal policies and regulations of the Site Parties during such inspection, to the extent these are sufficiently communicated to the Study Monitor or Auditor. For the avoidance of any doubt, the Sponsor shall be responsible for the confidential handling of all Personal Data of Clinical Study Subjects and other patients which the Study Monitor or Auditor comes across with during their monitoring or auditing activities. Before the start of the monitoring or auditing visits, the Sponsor shall provide the Site Parties with the name of the appointed Study Monitor or auditor, and hereby warrants (in Dutch: “staat garant”) that such Study Monitor or Auditor shall timely sign a confidentiality statement regarding the above by means of a specific letter. of the template for such letter is annexed to this Agreement below, as Annex 4. The Site Parties shall promptly inform the Sponsor in writing of any intended or actual inspection, written enquiry and/or visit to the Site Parties by any regulatory authority in connection with the Clinical Study and forward to the Sponsor copies of any correspondence from any such regulatory authority relating to the Clinical Study. The Site Parties shall allow Sponsor’s representatives to be present during any such visit. The Site Parties shall take appropriate measures and/or corrective actions without delay as the Sponsor may reasonably require in order to solve all problems found and reported by the Study Monitors, Auditor or officers from regulatory authorities or during an inspection under clause 6.2. The Site Parties shall permit authorized representatives of the Ethics Committee and Competent Authorities to have access to and verify information relating to the Clinical Study, as required by and in accordance with applicable Law. Parties acknowledge that the Clinical Study is subject to inspection by regulatory authorities worldwide and that such inspections may occur after the completion of the Clinical Study. It is expressly agreed between the Parties that: the Sponsor will not compensate the Site 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 the assistance or guidance of Study Monitors or Sponsor’s Auditors by the Site Investigator and the Research Staff shall not be compensated by Sponsor, unless expressly agreed otherwise in writing.

Quality Assurance and Control. 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. 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. The Site Parties shall permit the Study Monitor, Auditor Trial Monitor and any official with a legal right Auditor access to inspect and access all relevant documentation and source clinical data of Clinical Trial Subjects for monitoring of the progress of the Clinical StudyTrial, the proper collection and recording of Clinical Study Trial data, the welfare of the Clinical Study Trial Subjects, and altogether the good quality of the Clinical Study Trial and compliance with applicable Law and, if applicable and communicated to the Site Parties in writing, Sponsor’s standard operating procedures. The Study Monitor and Auditorand/or CRO’s access will be arranged at mutually convenient times and on reasonable notice with no additional costs for the Study Monitor, Auditor or Sponsor. The Study Monitor and Auditor will comply with all internal policies and regulations of the Site Parties during such inspection, to the extent these are sufficiently communicated to the Study Monitor or AuditorStandard Operating Procedures. For the avoidance of any doubt, the Sponsor shall be responsible for the confidential handling of all Personal Data personal data of Clinical Study Subjects and other patients which the Study Trial Monitor or and any Auditor comes across with during their its monitoring or auditing activities. Before the start of the monitoring or auditing visits, the Sponsor shall provide the Site Parties with the name of the appointed Study Monitor or auditor, and hereby warrants (in Dutch: “staat garant”) that such Study Monitor or Auditor shall timely sign a confidentiality statement regarding the above by means of a specific letter. of the template for such letter is annexed to this Agreement below, as Annex 4. The Site Parties shall promptly inform the Sponsor in writing and/or CRO of any intended or actual inspection, written enquiry and/or visit to the Trial Site Parties by any regulatory authority in connection with the Clinical Study Trial and forward to the Sponsor copies of any correspondence from any such regulatory authority relating to the Clinical StudyTrial. The Site Parties shall allow Sponsor’s Sponsor and/or CRO representatives to be present during any such visit. The Site Parties shall take appropriate measures and/or corrective actions without delay visit as the Sponsor may reasonably require in order to solve all problems found and reported permitted by the Study Monitors, Auditor or officers from regulatory authorities or during an inspection under clause 6.2Law. The Site Parties shall permit authorized representatives of the Ethics Committee and Competent Authorities to have access to to, copy and verify information relating to the Clinical StudyTrial, as required by and in accordance with applicable Law. Parties acknowledge 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 Study Trial is subject to inspection by regulatory authorities worldwide and that such inspections may occur after the completion of the Clinical StudyTrial. 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. It is expressly agreed between the Parties that: that the Sponsor will not compensate the Site 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 the assistance or guidance of Study Trial Monitors or Sponsor’s Auditors by the Site Principal Investigator and the Research Staff shall not be compensated by Sponsor, deemed included in the remuneration paid pursuant to clause 13 hereinafter unless expressly agreed otherwise in writing. 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. 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. 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 to the extent these are sufficiently communicated to the Trial Monitor. The Site Parties shall permit the Study Monitor, Auditor Trial Monitor and any official with a legal right Auditor access to inspect and access all relevant documentation clinical data of Clinical Trial Subjects and relevant source data documents for monitoring of the progress of the Clinical StudyTrial, the proper collection and recording of Clinical Study Trial data, the welfare of the Clinical Study Trial Subjects, and altogether the good quality of the Clinical Study Trial and compliance with applicable Law and, if applicable and communicated to the Site Parties in writing, Sponsor’s standard operating procedures. The Study Monitor and Auditorand/or CRO’s access will be arranged at mutually convenient times and on reasonable notice with no additional costs for the Study Monitor, Auditor or Sponsor. The Study Monitor and Auditor will comply with all internal policies and regulations of the Site Parties during such inspection, to the extent these are sufficiently communicated to the Study Monitor or AuditorStandard Operating Procedures. For the avoidance of any doubt, the Sponsor shall be responsible for the confidential handling of all Personal Data of Clinical Study Trial Subjects and other patients which the Study Trial Monitor or and any Auditor comes across with during their its monitoring or auditing activities. Before the start of the monitoring or auditing visits, the Sponsor shall provide the Site Parties Institution with the name and date of birth of the appointed Study Monitor or auditormonitor, and hereby warrants (in Dutch: “staat garant”) declare that such Study Trial Monitor or Auditor shall timely sign has signed a confidentiality statement regarding the above by means of a specific letter. of the template for such letter is annexed to this Agreement below, as Annex 4above. The Site Parties shall promptly inform the Sponsor in writing and/or CRO of any intended or actual inspection, written enquiry and/or visit to the Trial Site Parties by any regulatory authority in connection with the Clinical Study Trial and forward to the Sponsor copies of any correspondence from any such regulatory authority relating to the Clinical StudyTrial. The Site Parties shall allow Sponsor’s Sponsor and/or CRO representatives to be present during any such visit. The Site Parties shall take appropriate measures and/or corrective actions without delay visit as the Sponsor may reasonably require in order to solve all problems found and reported permitted by the Study Monitors, Auditor or officers from regulatory authorities or during an inspection under clause 6.2Law. The Site Parties shall permit authorized representatives of the Ethics Committee and Competent Authorities to have access to to, copy and verify information relating to the Clinical StudyTrial, 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. Parties acknowledge that the Clinical Study Trial is subject to inspection by regulatory authorities worldwide and that such inspections may occur after the completion of the Clinical StudyTrial. 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. It is expressly agreed between the Parties that: that the Sponsor will not compensate the Site 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 the assistance or guidance of Study Trial Monitors or Sponsor’s Auditors by the Site Principal Investigator and the Research Staff shall not be compensated by Sponsor, deemed included in the remuneration paid pursuant to clause 13 hereinafter unless expressly agreed otherwise in writing. The Principal Investigator and any member of the Research Staff will be trained by Sponsor with respect to the use of eCRFs.

Quality Assurance and Control. The Site Parties shall permit the Study Monitor, Auditor and any official with a legal right to inspect and access all relevant documentation and source data for monitoring of the progress of the Clinical Study, the proper collection and recording of Clinical Study data, the welfare of the Clinical Study Subjects, and altogether the good quality of the Clinical Study and compliance with applicable Law and, if applicable and communicated to the Site Parties in writing, Sponsor’s standard operating procedures. The Study Monitor and Auditor’s access will be arranged at mutually convenient times and on reasonable notice with no additional costs for the Study Monitor, Auditor or Sponsor. The Study Monitor and Auditor will comply with all internal policies and regulations of the Site Parties during such inspection, to the extent these are sufficiently communicated to the Study Monitor or Auditor. For the avoidance of any doubt, the Sponsor shall be responsible for the confidential handling of all Personal Data of Clinical Study Subjects and other patients which the Study Monitor or Auditor comes across with during their monitoring or auditing activities. Before the start of the monitoring or auditing visits, the Sponsor shall provide the Site Parties with the name of the appointed Study Monitor or auditorMonitor, and hereby warrants (in Dutch: “staat garant”) declare that such Study Monitor or Auditor shall timely sign has signed a confidentiality statement regarding the above by means above. An example of a specific letter. of the template for such assignment letter is annexed to this Agreement below, as Annex 4. The Site Parties shall promptly inform the Sponsor in writing of any intended or actual inspection, written enquiry and/or visit to the Site Parties by any regulatory authority in connection with the Clinical Study and forward to the Sponsor copies of any correspondence from any such regulatory authority relating to the Clinical Study. The Site Parties shall allow Sponsor’s representatives to be present during any such visit. The Site Parties shall take appropriate measures and/or corrective actions without delay as the Sponsor may reasonably require in order to solve all problems found and reported by the Study Monitors, Auditor or officers from regulatory authorities or during an inspection under clause 6.2. The Site Parties shall permit authorized representatives of the Ethics Committee and Competent Authorities to have access to and verify information relating to the Clinical Study, as required by and in accordance with applicable Law. Parties acknowledge that the Clinical Study is subject to inspection by regulatory authorities worldwide and that such inspections may occur after the completion of the Clinical Study. It is expressly agreed between the Parties that: the Sponsor will not compensate the Site 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 the assistance or guidance of Study Monitors or Sponsor’s Auditors by the Site Investigator and the Research Staff shall not be compensated by Sponsor, unless expressly agreed otherwise in writing.

Quality Assurance and Control. The Site Parties shall permit the Study Monitor, Auditor Trial Monitor and any official with a legal right Auditor access to inspect and access all relevant documentation and source clinical data of Clinical Trial Subjects for monitoring of the progress of the Clinical StudyTrial, the proper collection and recording of Clinical Study Trial data, the welfare of the Clinical Study Trial Subjects, and altogether the good quality of the Clinical Study Trial and compliance with applicable Law and, if applicable and communicated to the Site Parties in writing, Sponsor’s standard operating proceduresStandard Operating Procedures. The Study Monitor and AuditorTrial Monitor’s access will be arranged at mutually convenient times and on reasonable notice with no additional costs for the Study Monitor, Auditor or Sponsornotice. The Study Monitor and Auditor will comply with all internal policies and regulations 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 acknowledges and agrees that the Institution executive management and local ethics committee will have the right to audit the performance of the Clinical Trial at the Trial Site. In the event that the Sponsor reasonably believes there has been any research misconduct in relation to the Clinical Trial, Site Parties during such inspectionshall provide all reasonable assistance to any investigation into any alleged research misconduct undertaken by or on behalf of the Sponsor, the results of which the Party on whose behalf the investigation was undertaken shall, subject to any obligations of confidentiality, communicate to the extent these are sufficiently communicated Principal Investigator. In the event that the Principal Investigator reasonably believes there has been any research misconduct in relation to the Study Monitor or Auditor. For the avoidance of any doubt, the Sponsor shall be responsible for the confidential handling of all Personal Data of Clinical Study Subjects and other patients which the Study Monitor or Auditor comes across with during their monitoring or auditing activities. Before the start of the monitoring or auditing visitsTrial, the Sponsor shall provide the Site Parties with the name all reasonable assistance to any investigation undertaken by or on behalf of the appointed Study Monitor or auditorPrincipal Investigator, and hereby warrants (in Dutch: “staat garant”) that such Study Monitor or Auditor shall timely sign a confidentiality statement regarding the above by means results of a specific letter. which shall, subject to any obligations of confidentiality, be communicated to the template for such letter is annexed to this Agreement below, as Annex 4Sponsor. The Site Parties Principal Investigator or the Institution shall promptly inform the Sponsor in writing of any intended or actual inspection, written enquiry and/or visit to the Trial Site Parties by any regulatory authority in connection with the Clinical Study Trial and forward to the Sponsor copies of any correspondence from any such regulatory authority relating to the Clinical StudyTrial. The Site Parties shall allow Sponsor’s Sponsor representatives to be present during any such visit. 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 to determine that the Clinical Trial is being conducted in accordance with the Protocol, this Agreement and applicable Law. The Principal Investigator shall take appropriate measures and/or and cause the Research Staff to take appropriate measures and corrective actions without delay as the Sponsor may reasonably require in order to solve all problems found and reported by the Study MonitorsTrial Monitors and any of the aforesaid Auditors, Auditor or officers from regulatory authorities or during an inspection under clause 6.2. The Site Parties shall permit authorized representatives of the Ethics Committee and Committee, Competent Authorities to have access to and verify information relating to the Clinical Study, as required by and in accordance with applicable Law. Parties acknowledge that the Clinical Study is subject to inspection by Authority or other regulatory authorities worldwide and that such inspections may occur after the completion of the Clinical Studyauthority. It is expressly agreed between the Parties that: that (a) the Sponsor will not compensate the Site 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 Study Trial Monitors or Sponsor’s Auditors auditors by the Site Principal Investigator and the Research Staff shall not be compensated by Sponsor, deemed included in the remuneration paid pursuant to clause 12 hereinafter unless expressly agreed otherwise in writing. The Principal Investigator shall submit CRF/eCRFs to the Sponsor. If needed, Sponsor will provide the Principal Investigator with a computer and or internet connection in order to submit e-CRFs for the Clinical Trial. 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. The Principal Investigator 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 case report form (CRF) /electronic case report form (e-CRF) will accurately reflect source documents.

Quality Assurance and Control. The Study Site Parties shall permit the Study Monitor, Auditor Executive Committee and any official with a legal right to inspect and access all relevant documentation and source data for monitoring of the progress of the Clinical Non-interventional Study, the proper collection and recording of Clinical Non-interventional Study data, the welfare of the Clinical Non-interventional Study Subjects, and altogether the good quality of the Clinical Non-interventional Study and compliance with applicable Law and, if applicable and communicated to the Site Parties in writing, Sponsor’s standard operating procedures. The Study Monitor and AuditorExecutive Committee ’s access will be arranged at mutually convenient times and on reasonable notice with no additional costs for the Study Monitor, Auditor Executive Committee or Sponsor, after Sponsor has provided Study Site the contact details of the Executive Committee . The Study Monitor and Auditor Executive Committee will comply with all internal policies and regulations of the Study Site Parties during such inspection, to the extent these are sufficiently communicated to the Study Monitor or Auditor. For the avoidance of any doubt, the Sponsor shall be responsible for the confidential handling of all Personal Data personal data of Clinical Non-interventional Study Subjects and other patients which the Study Monitor Executive Committee or Auditor Sponsor comes across with during their monitoring or auditing activities. Before such inspection and will let the start of the monitoring or auditing visits, the Sponsor shall provide the Site Parties with the name of the appointed Study Monitor or auditor, and hereby warrants (in Dutch: “staat garant”) that such Study Monitor or Auditor shall timely Executive Committee sign a confidentiality statement regarding the above by means of a specific letter. of the template for declaration prior to such letter is annexed to this Agreement below, as Annex 4inspection. The Site Parties Investigator or the Study Site shall promptly inform the Sponsor in writing of any intended or actual inspection, written enquiry and/or visit to the Study Site Parties by any regulatory authority in connection with the Clinical Non-interventional Study and forward to the Sponsor copies of any correspondence from any such regulatory authority relating to the Clinical Non-interventional Study. The Site Parties shall allow Sponsor’s representatives to be present during any such visit. The Site Parties Investigator shall take appropriate measures and/or corrective actions without delay as the Sponsor may reasonably require in order to solve all problems found and reported by the Study Monitors, Auditor Executive Committee s or officers from regulatory authorities or during an inspection under clause 6.2. The Site Parties shall permit authorized representatives of the Ethics Committee and Competent Authorities to have access to and verify information relating to the Clinical Study, as required by and in accordance with applicable Law. Parties acknowledge that the Clinical Study is subject to inspection by regulatory authorities worldwide and that such inspections may occur after the completion of the Clinical Study. It is expressly agreed between the Parties that: the Sponsor will not compensate the Site 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 the assistance or guidance of Study Monitors or Sponsor’s Auditors by the Site Investigator and the Research Staff shall not be compensated by Sponsor, unless expressly agreed otherwise in writing.

Quality Assurance and Control. The Site Parties shall permit the Study Monitor, Auditor Trial Monitor and any official with a legal right Auditor access to inspect and access all relevant documentation and source clinical data of Clinical Trial Subjects for monitoring of the progress of the Clinical StudyTrial, the proper collection and recording of Clinical Study Trial data, the welfare of the Clinical Study Trial Subjects, and altogether the good quality of the Clinical Study Trial and compliance with applicable Law and, if applicable and communicated to the Site Parties in writing, Sponsor’s standard operating proceduresand/or CRO’s Standard Operating Procedures. The Study Monitor and AuditorTrial Monitor’s access will be arranged at mutually convenient times and on reasonable notice with no additional costs for the Study Monitor, Auditor or Sponsor. The Study Monitor and Auditor will comply with all internal policies and regulations of the Site Parties during such inspection, to the extent these are sufficiently communicated to the Study Monitor or Auditor. For the avoidance of any doubt, the Sponsor shall be responsible for the confidential handling of all Personal Data of Clinical Study Subjects and other patients which the Study Monitor or Auditor comes across with during their monitoring or auditing activities. Before the start of the monitoring or auditing visits, the Sponsor shall provide the Site Parties with the name of the appointed Study Monitor or auditor, and hereby warrants (in Dutch: “staat garant”) that such Study Monitor or Auditor shall timely sign a confidentiality statement regarding the above by means of a specific letter. of the template for such letter is annexed to this Agreement below, as Annex 4. The Site Parties shall promptly inform the Sponsor in writing of any intended or actual inspection, written enquiry and/or visit to the Site Parties by any regulatory authority in connection with the Clinical Study and forward to the Sponsor copies of any correspondence from any such regulatory authority relating to the Clinical Study. The Site Parties shall allow Sponsor’s representatives to be present during any such visit. The Site Parties shall take appropriate measures and/or corrective actions without delay as the Sponsor may reasonably require in order to solve all problems found and reported by the Study Monitors, Auditor or officers from regulatory authorities or during an inspection under clause 6.2notice. The Site Parties shall permit authorized representatives of the Ethics Committee and Competent Authorities to have access to to, copy and verify information relating to the Clinical StudyTrial, as required by and in accordance with applicable Law. Parties acknowledge 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 Study Trial is subject to inspection by regulatory authorities worldwide and that such inspections may occur after the completion of the Clinical StudyTrial. 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 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. 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. 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. It is expressly agreed between the Parties that: that (a) the Sponsor will not compensate the Site 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 Study Trial Monitors or Sponsor’s Auditors by the Site Principal Investigator and the Research Staff shall not be compensated by Sponsor, deemed included in the remuneration paid pursuant to clause 13 hereinafter unless expressly agreed otherwise in writing. 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. 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.

Quality Assurance and Control. The Site Parties Institution and Principal Investigator shall permit the Study Monitor, Auditor Trial Monitor and any official with a legal right Auditor direct access to inspect and access all relevant documentation clinical data of Clinical Trial Subjects for monitoring and source data for monitoring of the progress of the Clinical Studyverification, the proper collection and recording of Clinical Study data, the welfare of the Clinical Study Subjects, and altogether the good quality of the Clinical Study and compliance with applicable Law and, if applicable and communicated such direct access to the Site Parties in writing, Sponsor’s standard operating procedures. The Study Monitor and Auditor’s access will be arranged at mutually convenient times and on reasonable notice with no additional costs notice. Such monitoring may take such form as Sponsor reasonably thinks appropriate including the right to inspect any facility being used for the Study Monitorconduct of the Clinical Trial and to examine any procedures or records relating to the Clinical Trial. Sponsor will alert Institution promptly to significant issues relating to the conduct of the Clinical Trial. Institution shall permit authorized representatives of the Ethics Committee and Competent Authority or any other regulatory authority access to, Auditor copy and verify information relating to the Clinical Trial, as required by applicable legislation or requested by Sponsor. The Study Monitor In the event that the Sponsor reasonably believes there has been any research misconduct in relation to the Clinical Trial, the Institution and Auditor will comply with the Principal Investigator shall provide all internal policies and regulations reasonable assistance to any investigation into any alleged research misconduct undertaken by or on behalf of the Site Parties during such inspectionSponsor, the results of which the Party on whose behalf the investigation was undertaken shall, subject to any obligations of confidentiality, communicate to the extent these are sufficiently communicated Institution. In the event that the Institution reasonably believes there has been any research misconduct in relation to the Study Monitor or Auditor. For the avoidance of any doubt, the Sponsor shall be responsible for the confidential handling of all Personal Data of Clinical Study Subjects and other patients which the Study Monitor or Auditor comes across with during their monitoring or auditing activities. Before the start of the monitoring or auditing visitsTrial, the Sponsor shall provide the Site Parties with the name all reasonable assistance to any investigation undertaken by or on behalf of the appointed Study Monitor Institution or auditorPrincipal Investigator, and hereby warrants (in Dutch: “staat garant”) that such Study Monitor or Auditor shall timely sign a confidentiality statement regarding the above by means results of a specific letter. which shall, subject to any obligations of confidentiality, be communicated to the template for such letter is annexed to this Agreement below, as Annex 4Sponsor. The Site Parties Institution shall promptly inform the Sponsor in writing of any intended or actual inspection, written enquiry and/or visit to the Trial Site Parties by any regulatory authority in connection with the Clinical Study Trial and forward to the Sponsor copies of any correspondence from any such regulatory authority relating to the Clinical StudyTrial. The Site Parties Institution and Principal Investigator shall allow Sponsor’s Sponsor representatives to be present during any such visit. The Institution will permit Sponsor to examine the conduct of the Clinical Trial and the Trial Site Parties upon reasonable advance notice and in the company of an employee of Institution during regular business hours to determine that the Clinical Trial is being conducted in accordance with the Protocol, ICH GCP, the applicable regulatory requirements. Institution shall inform or cause the Principal Investigator to inform Sponsor of any significant problem which might occur or be found during the course of the Clinical Trial and which might hinder or adversely affect the proper performance of the Clinical Trial. Institution shall immediately inform or cause the Principal Investigator to immediately inform Sponsor of any serious adverse event (“SAE”) in accordance with the (Dutch) Medical Research Involving Human Subjects Act. Institution or the Principal Investigator shall report adverse events (“AE”) to Sponsor in accordance with the procedures outlined in the Protocol. Institution shall take appropriate such measures and/or corrective and actions without delay as the any regulatory authority or Sponsor may reasonably require for solving problems and issues reported by the Trial Monitors, the Auditor or any representative of the Ethics Committee, the Competent Authority or other regulatory authority in order to solve all problems found and reported by comply with the Study MonitorsProtocol, Auditor or officers from ICH GCP, the applicable regulatory authorities or during an inspection under clause 6.2requirements. The Site Parties shall permit authorized representatives of the Ethics Committee and Competent Authorities to have access to and verify information relating to the Clinical Study, as required by and in accordance with applicable Law. Parties acknowledge that the Clinical Study is subject to inspection by regulatory authorities worldwide and that such inspections may occur after the Upon completion of the Clinical StudyTrial (whether prematurely or otherwise) the Principal Investigator and Sponsor shall co-operate in producing a report of the Clinical Trial detailing the methodology, results and containing an analysis of the results and drawing appropriate conclusions. It is expressly agreed between understood and accepted by Institution and the Parties that: the Principal Investigator that Sponsor will not separately compensate Institution or the Site Principal Investigator nor any member of the Research Staff for (a) the assistance or guidance of representatives of the Ethics Committee, Competent Authority or other regulatory authority and (b) the assistance or guidance of Study Trial Monitors or Sponsor’s Auditors auditors by the Site Institution, Principal Investigator and the Research Staff Staff. Compensation for such activities shall not be compensated by Sponsordeemed included in the remuneration to be paid pursuant to clause 13 hereinafter, unless expressly agreed otherwise in writingwriting or laid down in Exhibit 2. The Institution shall submit CRF or CRFs to the Sponsor, completed, fully and truly, by or on behalf of the Principal Investigator. The Sponsor may agree with the Institution to (a) train the Principal Investigator and selected members of the Research Staff to learn about the use of eCRFs and the duties relative to the eCRF process, and (b) make a computer and/or internet connection available to the Institution to enable the Research Staff to submit eCRFs for the Clinical Trial to the Sponsor. The Institution shall ensure or cause the Principal Investigator to ensure that all procedures defined in the Protocol are complied with, that all data coming from 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 that the content of CRFs or e-CRFs will accurately reflect source documents.

Quality Assurance and Control. 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. 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. The Site Parties shall permit the Study Monitor, Auditor Trial Monitor and any official with a legal right Auditor access to inspect and access all relevant documentation and source clinical data of Clinical Trial Subjects for monitoring of the progress of the Clinical StudyTrial, the proper collection and recording of Clinical Study Trial data, the welfare of the Clinical Study Trial Subjects, and altogether the good quality of the Clinical Study Trial and compliance with applicable Law and, if applicable and communicated to the Site Parties in writing, Sponsor’s standard operating procedures. The Study Monitor and Auditorand/or CRO’s access will be arranged at mutually convenient times and on reasonable notice with no additional costs for the Study Monitor, Auditor or Sponsor. The Study Monitor and Auditor will comply with all internal policies and regulations of the Site Parties during such inspection, to the extent these are sufficiently communicated to the Study Monitor or AuditorStandard Operating Procedures. For the avoidance of any doubt, the Sponsor shall be responsible for the confidential handling of all Personal Data personal data of Clinical Study Subjects and other patients which the Study Trial Monitor or and any Auditor comes across with during their its monitoring or auditing activities. Before the start of the monitoring or auditing visits, the Sponsor shall provide the Site Parties with the name of the appointed Study Monitor or auditor, and hereby warrants (in Dutch: “staat garant”) that such Study Monitor or Auditor shall timely sign a confidentiality statement regarding the above by means of a specific letter. of the template for such letter is annexed to this Agreement below, as Annex 4. The Site Parties shall promptly inform the Sponsor in writing and/or CRO of any intended or actual inspection, written enquiry and/or visit to the Trial Site Parties by any regulatory authority in connection with the Clinical Study Trial and forward to the Sponsor copies of any correspondence from any such regulatory authority relating to the Clinical StudyTrial. The Site Parties shall allow Sponsor’s Sponsor and/or CRO representatives to be present during any such visit. The Site Parties shall take appropriate measures and/or corrective actions without delay visit as the Sponsor may reasonably require in order to solve all problems found and reported permitted by the Study Monitors, Auditor or officers from regulatory authorities or during an inspection under clause 6.2Law. The Site Parties shall permit authorized representatives of the Ethics Committee and Competent Authorities to have access to to, copy and verify information relating to the Clinical StudyTrial, as required by and in accordance with applicable Law. Parties acknowledge 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 Study Trial is subject to inspection by regulatory authorities worldwide and that such inspections may occur after the completion of the Clinical StudyTrial. 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. It is expressly agreed between the Parties that: that (a) the Sponsor will not compensate the Site 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 Study Trial Monitors or Sponsor’s Auditors by the Site Principal Investigator and the Research Staff shall not be compensated by Sponsor, deemed included in the remuneration paid pursuant to clause 13 hereinafter unless expressly agreed otherwise in writing. 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. 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. 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 to the extent these are made sufficiently knowable to the Trial Monitor. The Site Parties shall permit the Study Monitor, Auditor Trial Monitor and any official with a legal right Auditor access to inspect and access all relevant documentation clinical data of Clinical Trial Subjects and relevant source data documents for monitoring of the progress of the Clinical StudyTrial, the proper collection and recording of Clinical Study Trial data, the welfare of the Clinical Study Trial Subjects, and altogether the good quality of the Clinical Study Trial and compliance with applicable Law and, if applicable and communicated to the Site Parties in writing, Sponsor’s standard operating procedures. The Study Monitor and Auditorand/or CRO’s access will be arranged at mutually convenient times and on reasonable notice with no additional costs for the Study Monitor, Auditor or Sponsor. The Study Monitor and Auditor will comply with all internal policies and regulations of the Site Parties during such inspection, to the extent these are sufficiently communicated to the Study Monitor or AuditorStandard Operating Procedures. For the avoidance of any doubt, the Sponsor shall be responsible for the confidential handling of all Personal Data personal data of Clinical Study Subjects and other patients which the Study Trial Monitor or and any Auditor comes across with during their its monitoring or auditing activities. Before the start of the monitoring or auditing visits, the Sponsor shall provide the Site Parties Institution with the name and date of birth of the appointed Study Monitor or auditormonitor, and hereby warrants (in Dutch: “staat garant”) declare that such Study Monitor or Auditor shall timely sign monitor has signed a confidentiality statement regarding the above by means of a specific letter. of the template for such letter is annexed to this Agreement below, as Annex 4above. The Site Parties shall promptly inform the Sponsor in writing and/or CRO of any intended or actual inspection, written enquiry and/or visit to the Trial Site Parties by any regulatory authority in connection with the Clinical Study Trial and forward to the Sponsor copies of any correspondence from any such regulatory authority relating to the Clinical StudyTrial. The Site Parties shall allow Sponsor’s Sponsor and/or CRO representatives to be present during any such visit. The Site Parties shall take appropriate measures and/or corrective actions without delay visit as the Sponsor may reasonably require in order to solve all problems found and reported permitted by the Study Monitors, Auditor or officers from regulatory authorities or during an inspection under clause 6.2Law. The Site Parties shall permit authorized representatives of the Ethics Committee and Competent Authorities to have access to to, copy and verify information relating to the Clinical StudyTrial, 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. Parties acknowledge that the Clinical Study Trial is subject to inspection by regulatory authorities worldwide and that such inspections may occur after the completion of the Clinical StudyTrial. 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. It is expressly agreed between the Parties that: that the Sponsor will not compensate the Site 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 the assistance or guidance of Study Trial Monitors or Sponsor’s Auditors by the Site Principal Investigator and the Research Staff shall not be compensated by Sponsor, deemed included in the remuneration paid pursuant to clause 13. hereinafter unless expressly agreed otherwise in writing. The Principal Investigator and any member of the Research Staff will be trained by Sponsor with respect to the use of eCRFs.