Common use of Principal Investigator and Personnel Clause in Contracts

Principal Investigator and Personnel. The Participating Organisation represents that it is entitled to procure, and the Participating Organisation will procure the services of the Principal Investigator, any and all Sub-Investigators and other Personnel, to fulfil these functions and shall ensure the performance of the obligations of the Principal Investigator, any and all Sub-Investigators and other Personnel set out in Appendix 3 and elsewhere in this Agreement. Where the Participating Organisation is not the Principal Investigator’s substantive employer it will notify the Principal Investigator’s substantive employer in a timely way of the Principal Investigator’s proposed involvement in the Non-Interventional Study. Any financial or other arrangements relating to the Principal Investigator's involvement in the Non-Interventional Study will be agreed directly between the Participating Organisation and the Principal Investigator’s substantive employer. The Participating Organisation represents that the Principal Investigator holds the necessary registration and has the necessary expertise, time and resources to perform the Non-Interventional Study and will ensure that the Principal Investigator is made aware of and acknowledges the obligations applicable to the Principal Investigator set out in this Agreement, including but not limited to those set out in Appendix 3. The Participating Organisation shall notify the Sponsor if the Principal Investigator ceases to be employed by or associated with the Participating Organisation, is erased from the medical register (or equivalent UK professional register where the Principal Investigator is not a medical doctor) or is otherwise sanctioned by an applicable regulatory or other governmental authority, or is otherwise unavailable to continue as Principal Investigator. The Participating Organisation shall use all reasonable endeavours to find a replacement acceptable to both the Sponsor and the Participating Organisation, subject to the Participating Organisation’s overriding obligations in relation to Non-Interventional Study Subjects and individual patient care. If no mutually acceptable replacement can be found the Sponsor may terminate this Agreement pursuant to Clause 14.3. The Participating Organisation shall procure, and shall ensure that the Principal Investigator procures, the performance of the obligations of the Personnel as set out in this Agreement. The Principal Investigator and/or Personnel shall attend any meetings regarding the Non-Interventional Study as reasonably requested by the Sponsor (‘Investigator Meetings’). Such meetings to be conducted by the Sponsor to convey or exchange information with the Principal Investigator, all Sub-Investigators or other Personnel to support the effective conduct or close-out of the Non-Interventional Study. The Participating Organisation agrees that no additional compensation shall be due hereunder for Principal Investigator’s or any other Personnel’s respective participation in Investigator Meetings. The Sponsor shall reimburse or pay for reasonable pre-approved expenses for attendance at the Investigator Meetings upon receipt of documentation. It is further agreed that any such expenses will be paid at the rate of fair market value (as detailed in the applicable Code of Practice)and subject to the documentation evidencing the expenses being in sufficient detail for the Sponsor’s financial reporting purposes, provided that the required detail does not impose an unreasonable administrative burden upon the Participating Organisation. Such expenses may be publicly reportable. The Participating Organisation represents that it will support the Principal Investigator to make good faith diligent efforts to ensure the completion of all case report forms, where applicable, in a timely manner.

Principal Investigator and Personnel. The Participating Organisation represents that it is entitled to procure, and the Participating Organisation will procure the services of the Principal Investigator, any and all Sub-Investigators and other Personnel, to fulfil these functions and shall ensure the performance of the obligations of the Principal Investigator, any and all Sub-Investigators and other Personnel set out in Appendix 3 5 and elsewhere in this Agreement. Where the Participating Organisation is not the Principal Investigator’s substantive employer it will notify the Principal Investigator’s substantive employer in a timely way of the Principal Investigator’s proposed involvement in the Non-Interventional Study. Any financial or other arrangements relating to the Principal Investigator's involvement in the Non-Interventional Study will be agreed directly between the Participating Organisation and the Principal Investigator’s substantive employer. The Participating Organisation represents that the Principal Investigator holds the necessary registration and has the necessary expertise, time and resources to perform the Non-Interventional Study and will ensure that the Principal Investigator is made aware of and acknowledges the obligations applicable to the Principal Investigator set out in this Agreement, including but not limited to those set out in Appendix 3. The Participating Organisation shall notify the Sponsor and CRO if the Principal Investigator ceases to be employed by or associated with the Participating Organisation, is erased from the medical register (or equivalent UK professional register where the Principal Investigator is not a medical doctor) or is otherwise sanctioned by an applicable regulatory or other governmental authority, or is otherwise unavailable to continue as Principal Investigator. The Participating Organisation shall use all reasonable endeavours to find a replacement acceptable to both the Sponsor and the Participating Organisationall Parties, subject to the Participating Organisation’s overriding obligations in relation to Non-Interventional Study Subjects and individual patient care. If no mutually acceptable replacement can be found the Sponsor or CRO may terminate this Agreement pursuant to Clause 14.3. The Participating Organisation shall procure, and shall ensure that the Principal Investigator procures, the performance of the obligations of the Personnel as set out in this Agreement. The Principal Investigator and/or Personnel shall attend any meetings regarding the Non-Interventional Study as reasonably requested by the Sponsor or CRO (‘Investigator Meetings’). Such meetings to be conducted by the Sponsor or CRO to convey or exchange information with the Principal Investigator, all Sub-Investigators or other Personnel to support the effective conduct or close-out of the Non-Interventional Study. The Participating Organisation agrees that no additional compensation shall be due hereunder for Principal Investigator’s or any other Personnel’s respective participation in Investigator Meetings. The Sponsor or CRO shall reimburse or pay for reasonable pre-approved expenses for attendance at the Investigator Meetings upon receipt of documentation. It is further agreed that any such expenses will be paid at the rate of fair market value (as detailed in the applicable Code of Practice)and Practice) and subject to the documentation evidencing the expenses being in sufficient detail for the Sponsor’s financial reporting purposespurposes of the Party making payment, provided that the required detail does not impose an unreasonable administrative burden upon the Participating Organisation. Such expenses may be publicly reportable. The Participating Organisation represents that it will support the Principal Investigator to make good faith diligent efforts to ensure the completion of all case report forms, where applicable, in a timely manner. The Participating Organisation through the Principal Investigator may appoint such other persons as the Principal Investigator may deem appropriate as Sub-Investigators or other Personnel to assist in the conduct of the Non-Interventional Study. All Personnel will be adequately qualified, timely appointed and an updated list will be maintained. The Principal Investigator shall be responsible for leading such team of Personnel. The Participating Organisation and Principal Investigator are responsible for the services performed by the Personnel and undertake in particular to have the services executed by competent persons. In the event that the Participating Organisation and/or Principal Investigator use the services of others to conduct the Non-Interventional Study pursuant to this Agreement, the Participating Organisation and Principal Investigator shall be responsible for ensuring that all are appropriate, in compliance with the terms of this Agreement. The Participating Organisation shall be liable for any breach of this Agreement by the Principal Investigator and/or Personnel.

Principal Investigator and Personnel. The Participating Organisation represents that it is entitled to procure, and the Participating Organisation will procure the services of the Principal Investigator, any and all Sub-Investigators and other Personnel, to fulfil these functions and shall ensure the performance of the obligations of the Principal Investigator, any and all Sub-Investigators and other Personnel set out in Appendix 3 and elsewhere in this Agreement. Where the Participating Organisation is not the Principal Investigator’s substantive employer it will notify the Principal Investigator’s substantive employer in a timely way of the Principal Investigator’s proposed involvement in the Non-Interventional Study. Any financial or other arrangements relating to the Principal Investigator's involvement in the Non-Interventional Study will be agreed directly between the Participating Organisation and the Principal Investigator’s substantive employer. The Participating Organisation represents that the Principal Investigator holds the necessary registration and has the necessary expertise, time and resources to perform the Non-Interventional Study and will ensure that the Principal Investigator is made aware of and acknowledges the obligations applicable to the Principal Investigator set out in this Agreement, including but not limited to those set out in Appendix 3. The Participating Organisation shall notify the Sponsor and CRO if the Principal Investigator ceases to be employed by or associated with the Participating Organisation, is erased from the medical register (or equivalent UK professional register where the Principal Investigator is not a medical doctor) or is otherwise sanctioned by an applicable regulatory or other governmental authority, or is otherwise unavailable to continue as Principal Investigator. The Participating Organisation shall use all reasonable endeavours to find a replacement acceptable to both the Sponsor and the Participating Organisationall Parties, subject to the Participating Organisation’s overriding obligations in relation to Non-Interventional Study Subjects Participants and individual patient care. If no mutually acceptable replacement can be found the Sponsor or CRO may terminate this Agreement pursuant to Clause 14.3. The Participating Organisation shall procure, and shall ensure that the Principal Investigator procures, the performance of the obligations of the Personnel as set out in this Agreement. The Principal Investigator and/or and / or Personnel shall attend any meetings regarding the Non-Interventional Study as reasonably requested by the Sponsor or CRO (‘“Investigator Meetings’”). Such meetings to be conducted by the Sponsor or CRO to convey or exchange information with the Principal Investigator, all Sub-Investigators or other Personnel to support the effective conduct or close-out of the Non-Interventional Study. The Participating Organisation agrees that no additional compensation shall be due hereunder for Principal Investigator’s or any other Personnel’s respective participation in Investigator Meetings. The Sponsor or CRO shall reimburse or pay for reasonable pre-approved expenses for attendance at the Investigator Meetings upon receipt of documentation. It is further agreed that any such expenses will be paid at the rate of fair market value (as detailed in the applicable Code of Practice)and Practice) and subject to the documentation evidencing the expenses being in sufficient detail for the Sponsor’s financial reporting purposespurposes of the Party making payment, provided that the required detail does not impose an unreasonable administrative burden upon the Participating Organisation. Such expenses may be publicly reportable. The Participating Organisation represents that it will support the Principal Investigator to make good faith diligent efforts to ensure the completion of all case report forms, where applicable, in a timely manner.

Principal Investigator and Personnel. The Participating Organisation Trial Site represents that it is entitled to procure, and the Participating Organisation Trial Site will procure the services of the Principal Investigator, any and all Sub-Investigators and other Personnel, to fulfil these functions and shall ensure the performance of the obligations of the Principal Investigator, any and all Sub-Investigators and other Personnel set out in Appendix 3 5 and elsewhere in this Agreement. Where the Participating Organisation Trial Site is not the Principal Investigator’s substantive employer it will notify the Principal Investigator’s substantive employer in a timely way of the Principal Investigator’s their proposed involvement in the Non-Interventional StudyClinical Investigation. Any financial or other arrangements relating to the Principal Investigator's involvement in the Non-Interventional Study Clinical Investigation will be agreed directly between the Participating Organisation Trial Site and the Principal Investigator’s substantive employer. The Participating Organisation Trial Site represents that the Principal Investigator holds the necessary registration and has the necessary expertise, time and resources to perform the Non-Interventional Study Clinical Investigation and will ensure that the Principal Investigator is made aware of and acknowledges the obligations applicable to the Principal Investigator set out in this Agreement, including but not limited to those set out in Appendix 35. The Participating Organisation Trial Site shall notify the Sponsor if the Principal Investigator ceases to be employed by or associated with the Participating OrganisationTrial Site, is erased from the medical register (or equivalent UK professional register where the Principal Investigator is not a medical doctor) or is otherwise sanctioned by an applicable regulatory or other governmental authority, or is otherwise unavailable to continue as Principal Investigator. The Participating Organisation Trial Site shall use all reasonable endeavours to find a replacement acceptable to both the Sponsor and the Participating OrganisationTrial Site, subject to the Participating OrganisationTrial Site’s overriding obligations in relation to Non-Interventional Study Subjects Clinical Investigation Participants and individual patient care. If no mutually acceptable replacement can be found the Sponsor may terminate this Agreement pursuant to Clause 14.3. The Participating Organisation Trial Site shall procure, and shall ensure that the Principal Investigator procures, the performance of the obligations of the Personnel as set out in this Agreement. The Principal Investigator and/or and / or Personnel shall attend any meetings regarding the Non-Interventional Study Clinical Investigation as reasonably requested by the Sponsor (‘“Investigator Meetings’”). Such meetings to be conducted by the Sponsor to convey or exchange information with the Principal Investigator, all Sub-Investigators or other Personnel to support the effective conduct or close-out of the Non-Interventional StudyClinical Investigation. The Participating Organisation Trial Site agrees that no additional compensation shall be due hereunder for Principal Investigator’s or any other Personnel’s respective participation in Investigator Meetings. The Sponsor shall reimburse or pay for reasonable pre-approved expenses for attendance at the Investigator Meetings upon receipt of documentation. It is further agreed that any such expenses will be paid at the rate of fair market value (as detailed in line with the applicable ABHI Code of Practice)and Ethical Business Practice) and subject to the documentation evidencing the expenses being in sufficient detail for the Sponsor’s financial reporting purposes, provided that the required detail does not impose an unreasonable administrative burden upon the Participating OrganisationTrial Site. Such expenses may be publicly reportable. The Participating Organisation Trial Site represents that it will support the Principal Investigator to make good faith diligent efforts to ensure the completion of all case report forms, where applicable, forms in a timely manner. The Trial Site through the Principal Investigator may appoint such other persons as the Principal Investigator may deem appropriate as Sub-Investigators or other Personnel to assist in the conduct of the Clinical Investigation. All Personnel will be adequately qualified, timely appointed and an updated list will be maintained. Principal Investigator shall be responsible for leading such team of Personnel. The Trial Site and Principal Investigator are responsible for the services performed by the Personnel and undertake in particular to have the services executed by competent persons. In the event that the Trial Site and / or Principal Investigator use the services of others to conduct the Clinical Investigation pursuant to this Agreement, the Trial Site and Principal Investigator shall be responsible for ensuring that all are appropriate, in compliance with the terms of this Agreement. The Trial Site shall be liable for any breach of this Agreement by the Principal Investigator and / or Personnel.

Principal Investigator and Personnel. The Participating Organisation represents that it is entitled to procure, and the Participating Organisation will procure the services of the Principal Investigator, any and all Sub-Investigators and other Personnel, to fulfil these functions and shall ensure the performance of the obligations of the Principal Investigator, any and all Sub-Investigators and other Personnel set out in Appendix 3 and elsewhere in this Agreement. Where the Participating Organisation is not the Principal Investigator’s substantive employer it will notify the Principal Investigator’s substantive employer in a timely way of the Principal Investigator’s his/her proposed involvement in the Non-Interventional StudyClinical Trial. Any financial or other arrangements relating to the Principal Investigator's involvement in the Non-Interventional Study Clinical Trial will be agreed directly between the Participating Organisation and the Principal Investigator’s substantive employer. The Participating Organisation represents that the Principal Investigator holds the necessary registration and has the necessary expertise, time and resources to perform the Non-Interventional Study Clinical Trial and will ensure that the Principal Investigator is made aware of and acknowledges the obligations applicable to the Principal Investigator set out in this Agreement, including but not limited to those set out in Appendix 3. The Participating Organisation shall notify the Sponsor if the Principal Investigator ceases to be employed by or associated with the Participating Organisation, is erased from the medical register (or equivalent UK Irish professional register where the Principal Investigator is not a medical doctor) or is otherwise sanctioned by an applicable regulatory or other governmental authority, or is otherwise unavailable to continue as Principal Investigator. The Participating Organisation shall use all reasonable endeavours to find a replacement acceptable to both the Sponsor and the Participating Organisation, subject to the Participating Organisation’s overriding obligations in relation to Non-Interventional Study Clinical Trial Subjects and individual patient care. If no mutually acceptable replacement can be found the Sponsor may terminate this Agreement pursuant to Clause 14.3. The Participating Organisation shall procure, and shall ensure that the Principal Investigator procures, the performance of the obligations of the Personnel as set out in this Agreement. The Principal Investigator and/or Personnel shall attend any meetings regarding the Non-Interventional Study Clinical Trial as reasonably requested by the Sponsor (‘“Investigator Meetings’”). Such meetings to be conducted by the Sponsor to convey or exchange information with the Principal Investigator, all Sub-Investigators or other Personnel to support the effective conduct or close-out of the Non-Interventional StudyClinical Trial. The Participating Organisation agrees that no additional compensation shall be due hereunder for Principal Investigator’s or any other Personnel’s respective participation in Investigator Meetings. The Sponsor shall reimburse or pay for reasonable pre-approved expenses for attendance at the Investigator Meetings upon receipt of documentation. It is further agreed that any such expenses will be paid at the rate of fair market value (as detailed in line with the applicable IPHA Code of Practice)and Practice) and subject to the documentation evidencing the expenses being in sufficient detail for the Sponsor’s financial reporting purposes, provided that the required detail does not impose an unreasonable administrative burden upon the Participating Organisation. Such expenses may be publicly reportable. The Participating Organisation represents that it will support the Principal Investigator to make good faith diligent efforts to ensure the completion of all case report forms, where applicable, forms in a timely manner.

Principal Investigator and Personnel. The Participating Organisation Service Provider represents that it is entitled to procure, procure and the Participating Organisation will procure the services of Sub-Investigator and other Personnel to fulfil the functions required in this Agreement and has the necessary expertise, time and resources to perform the Clinical Trial, as required by the Protocol, and instructed by the Principal Investigator outlined in Appendix 2. The Investigator Site represents that it is entitled to procure and will procure the Principal Investigator, any and all Sub-Investigators and other Personnel, to fulfil these functions and shall ensure the performance of the obligations of the Principal Investigator, any and all Sub-Investigators and other Personnel set out in Appendix 3 and elsewhere in this Agreement. Where the Participating Organisation is not the Principal Investigator’s substantive employer it will notify the Principal Investigator’s substantive employer in a timely way of the Principal Investigator’s proposed involvement in the Non-Interventional Study. Any financial or other arrangements relating to the Principal Investigator's involvement in the Non-Interventional Study will be agreed directly between the Participating Organisation and the Principal Investigator’s substantive employer. The Participating Organisation represents that the Principal Investigator holds the necessary registration and has the necessary expertise, time and resources to perform the Non-Interventional Study and will Clinical Trial. The Investigator Site shall ensure that the Principal Investigator is made aware of and acknowledges the obligations applicable to the Principal Investigator him as set out in this Agreement, including but not limited to those set out in Appendix 3. The Participating Organisation shall notify Service Provider represents that it is entitled to procure and will procure the Sponsor if Personnel, and represents that the Principal Investigator ceases Personnel hold the necessary registration and have the necessary expertise, time and resources to be employed by or associated with perform the Participating Organisation, is erased from the medical register (or equivalent UK professional register where the Principal Investigator is not a medical doctor) or is otherwise sanctioned by an applicable regulatory or other governmental authority, or is otherwise unavailable to continue as Principal InvestigatorClinical Trial. The Participating Organisation shall use all reasonable endeavours to find a replacement acceptable to both the Sponsor and the Participating Organisation, subject to the Participating Organisation’s overriding obligations in relation to Non-Interventional Study Subjects and individual patient care. If no mutually acceptable replacement can be found the Sponsor may terminate this Agreement pursuant to Clause 14.3. The Participating Organisation shall procure, and Service Provider shall ensure that the Principal Investigator procures, the performance of Personnel are made aware and acknowledge the obligations of the Personnel application to them as set out in this Agreement, including but not limited to those set out in Appendix 2. The Principal Service Provider must ensure the Sub-Investigator and/or other Personnel shall as appropriate, attend any meetings regarding the Non-Interventional Study Clinical Trial as reasonably requested by the Sponsor Investigator Site (‘Investigator “Clinical Trial Meetings’”). Such meetings to be conducted by the Sponsor to convey or exchange information with the Principal Investigator, all Sub-Investigators or other Personnel to support the effective conduct or close-out of the Non-Interventional Study. The Participating Organisation Service Provider agrees that no additional compensation shall be due hereunder for Principal the Sub-Investigator’s or any other Personnel’s respective participation in Investigator any Clinical Trial Meetings. [The Sponsor Investigator Site shall reimburse or pay for reasonable pre-approved expenses for attendance at the Investigator Clinical Trial Meetings upon receipt of documentationsufficient evidence. It is further agreed that any such expenses will be paid at the rate of fair market value (as detailed in the applicable Code of Practice)and subject to the documentation evidencing the expenses being in sufficient detail for the Sponsor’s financial reporting purposes, provided that the required detail does not impose an unreasonable administrative burden upon the Participating Organisationvalue. Such expenses may be publicly reportable. DELETE IF NOT APPLICABLE] The Participating Organisation Service Provider represents that it will support the Principal Sub Investigator and Personnel to make good faith diligent efforts to ensure the completion of all case report forms, where applicable, forms in a timely mannermanner under the instruction and oversight of the Principal Investigator. Clinical Trial Governance The Parties must comply with all laws applicable to the performance of the Clinical Trial including, but not limited to, the Human Rights Act 1998, the Data Protection Laws and Guidance, the Medicines Act 1968, the Medicines for Human Use (Clinical Trials) Regulations 2004 (as amended), the Bribery Act 2010, the Freedom of Information Act 2000, and with all relevant guidance relating to medicines and clinical trials from time to time in force including, but not limited to, the ICH GCP, the World Medical Association Declaration of Helsinki entitled 'Ethical Principles for Medical Research Involving Human Subjects' (1996 version) and the UK Policy Framework for Health and Social Care Research v3.3, November 2017, as amended from time to time. Obligations of the Parties The Service Provider shall permit the Investigator Site access to the records of Clinical Trial Subjects to the extent considered necessary by the Investigator Site and the Principal Investigator for the safety of Clinical Trial Subjects. The Service Provider shall also permit access for the Monitor, such access to be arranged at mutually convenient times and on reasonable notice. The Investigator Site confirms that the Principal Investigator shall be responsible for reporting adverse events as outlined in the Protocol. The Investigator Site confirms that if the Principal Investigator is not present at the Service Provider Location(s) at the time the adverse event has occurred or has been recorded, the Principal Investigator will assess the causality and categorisation of the adverse event remotely. The Service Provider confirms that in the event of Clause 5.3, the Sub-Investigator will support the Principal Investigator in his assessment of the causality and categorisation of the adverse event. Where it is not possible to determine remotely the causation and categorisation of the adverse event, the Principal Investigator will visit the Service Provider Location to complete a full assessment within the timeframe and obligations stipulated in the Protocol. The Investigator Site confirms that if the Principal Investigator has assessed remotely and determined that the adverse event is categorised as a SUSAR, the Principal Investigator will call an urgent Clinical Trial meeting (“Exceptional Investigator Team Meeting”). The Exceptional Investigator Team Meeting will consist of the Principal Investigator (chair), the Sub-Investigator and (where appropriate) other Personnel to discuss the causation and categorisation. The Principal Investigator will complete all the appropriate reporting documents within the timeframe and obligations stipulated in the Protocol. The Investigator Site confirms that through the site agreement between itself and the Sponsor, the Sponsor has confirmed that during the course of the Clinical Trial, if the Sponsor becomes aware of any information relating to the IMP which may impact the Clinical Trial, the Sponsor will notify the Investigator Site promptly or within seven (7) calendar days of becoming aware of the information, and if requested to do so, the Sponsor will provide a report detailing the information which will be disseminated to the Sub Investigator and Personnel as a matter of urgency. Subject to Clause 12, the Service Provider shall inform the Investigator Site within 24 hours of becoming aware of any situation which it considers would render it unable to complete its obligations under this Agreement.

Principal Investigator and Personnel. The Participating Organisation represents that it is entitled to procure, and the Participating Organisation will procure the services of the Principal Investigator, any and all Sub-Investigators and other Personnel, to fulfil these functions and shall ensure the performance of the obligations of the Principal Investigator, any and all Sub-Investigators and other Personnel set out in Appendix 3 5 and elsewhere in this Agreement. Where the Participating Organisation is not the Principal Investigator’s substantive employer it will notify the Principal Investigator’s substantive employer in a timely way of the Principal Investigator’s his/her proposed involvement in the Non-Interventional StudyClinical Trial. Any financial or other arrangements relating to the Principal Investigator's involvement in the Non-Interventional Study Clinical Trial will be agreed directly between the Participating Organisation and the Principal Investigator’s substantive employer. The Participating Organisation represents that the Principal Investigator holds the necessary registration and has the necessary expertise, time and resources to perform the Non-Interventional Study Clinical Trial and will ensure that the Principal Investigator is made aware of and acknowledges the obligations applicable to the Principal Investigator set out in this Agreement, including but not limited to those set out in Appendix 35. The Participating Organisation shall notify the Sponsor if the Principal Investigator ceases to be employed by or associated with the Participating Organisation, is erased from the medical register (or equivalent UK professional register where the Principal Investigator is not a medical doctor) or is otherwise sanctioned by an applicable regulatory or other governmental authority, or is otherwise unavailable to continue as Principal Investigator. The Participating Organisation shall use all reasonable endeavours to find a replacement acceptable to both the Sponsor and the Participating Organisation, subject to the Participating Organisation’s overriding obligations in relation to Non-Interventional Study Clinical Trial Subjects and individual patient care. If no mutually acceptable replacement can be found the Sponsor may terminate this Agreement pursuant to Clause 14.3. The Participating Organisation shall procure, and shall ensure that the Principal Investigator procures, the performance of the obligations of the Personnel as set out in this Agreement. The Principal Investigator and/or Personnel shall attend any meetings regarding the Non-Interventional Study Clinical Trial as reasonably requested by the Sponsor (‘“Investigator Meetings’”). Such meetings to be conducted by the Sponsor to convey or exchange information with the Principal Investigator, all Sub-Investigators or other Personnel to support the effective conduct or close-out of the Non-Interventional StudyClinical Trial. The Participating Organisation agrees that no additional compensation shall be due hereunder for Principal Investigator’s or any other Personnel’s respective participation in Investigator Meetings. The Sponsor shall reimburse or pay for reasonable pre-approved expenses for attendance at the Investigator Meetings upon receipt of documentation. It is further agreed that any such expenses will be paid at the rate of fair market value (as detailed in line with the applicable ABPI Code of Practice)and Practice) and subject to the documentation evidencing the expenses being in sufficient detail for the Sponsor’s financial reporting purposes, provided that the required detail does not impose an unreasonable administrative burden upon the Participating Organisation. Such expenses may be publicly reportable. The Participating Organisation represents that it will support the Principal Investigator to make good faith diligent efforts to ensure the completion of all case report forms, where applicable, forms in a timely manner. The Participating Organisation through the Principal Investigator may appoint such other persons as the Principal Investigator may deem appropriate as Sub-Investigators or other Personnel to assist in the conduct of the Clinical Trial. All Personnel will be adequately qualified, timely appointed and an updated list will be maintained. Principal Investigator shall be responsible for leading such team of Personnel. The Participating Organisation and Principal Investigator are responsible for the services performed by the Personnel and undertake in particular to have the services executed by competent persons. In the event that the Participating Organisation and/or Principal Investigator use the services of others to conduct the Clinical Trial pursuant to this Agreement, the Participating Organisation and Principal Investigator shall be responsible for ensuring that all are appropriate, in compliance with the terms of this Agreement. The Participating Organisation shall be liable for any breach of this Agreement by the Principal Investigator and/or Personnel.

Principal Investigator and Personnel. The Participating Organisation Trial Site represents that it is entitled to procure, and the Participating Organisation Trial Site will procure the services of the Principal Investigator, any and all Sub-Investigators and other Personnel, to fulfil these functions and shall ensure the performance of the obligations of the Principal Investigator, any and all Sub-Investigators and other Personnel set out in Appendix 3 5 and elsewhere in this Agreement. Where the Participating Organisation Trial Site is not the Principal Investigator’s substantive employer it will notify the Principal Investigator’s substantive employer in a timely way of the Principal Investigator’s his/her proposed involvement in the Non-Interventional StudyClinical Investigation. Any financial or other arrangements relating to the Principal Investigator's involvement in the Non-Interventional Study Clinical Investigation will be agreed directly between the Participating Organisation Trial Site and the Principal Investigator’s substantive employer. The Participating Organisation Trial Site represents that the Principal Investigator holds the necessary registration and has the necessary expertise, time and resources to perform the Non-Interventional Study Clinical Investigation and will ensure that the Principal Investigator is made aware of and acknowledges the obligations applicable to the Principal Investigator set out in this Agreement, including but not limited to those set out in Appendix 35. The Participating Organisation Trial Site shall notify the Sponsor if the Principal Investigator ceases to be employed by or associated with the Participating OrganisationTrial Site, is erased from the medical register (or equivalent UK professional register where the Principal Investigator is not a medical doctor) or is otherwise sanctioned by an applicable regulatory or other governmental authority, or is otherwise unavailable to continue as Principal Investigator. The Participating Organisation Trial Site shall use all reasonable endeavours to find a replacement acceptable to both the Sponsor and the Participating OrganisationTrial Site, subject to the Participating OrganisationTrial Site’s overriding obligations in relation to Non-Interventional Study Clinical Investigation Subjects and individual patient care. If no mutually acceptable replacement can be found the Sponsor may terminate this Agreement pursuant to Clause 14.3. The Participating Organisation Trial Site shall procure, and shall ensure that the Principal Investigator procures, the performance of the obligations of the Personnel as set out in this Agreement. The Principal Investigator and/or Personnel shall attend any meetings regarding the Non-Interventional Study Clinical Investigation as reasonably requested by the Sponsor (‘“Investigator Meetings’”). Such meetings to be conducted by the Sponsor to convey or exchange information with the Principal Investigator, all Sub-Investigators or other Personnel to support the effective conduct or close-out of the Non-Interventional StudyClinical Investigation. The Participating Organisation Trial Site agrees that no additional compensation shall be due hereunder for Principal Investigator’s or any other Personnel’s respective participation in Investigator Meetings. The Sponsor shall reimburse or pay for reasonable pre-approved expenses for attendance at the Investigator Meetings upon receipt of documentation. It is further agreed that any such expenses will be paid at the rate of fair market value (as detailed in line with the applicable ABHI Code of Practice)and Ethical Business Practice) and subject to the documentation evidencing the expenses being in sufficient detail for the Sponsor’s financial reporting purposes, provided that the required detail does not impose an unreasonable administrative burden upon the Participating OrganisationTrial Site. Such expenses may be publicly reportable. The Participating Organisation Trial Site represents that it will support the Principal Investigator to make good faith diligent efforts to ensure the completion of all case report forms, where applicable, forms in a timely manner. The Trial Site through the Principal Investigator may appoint such other persons as the Principal Investigator may deem appropriate as Sub-Investigators or other Personnel to assist in the conduct of the Clinical Investigation. All Personnel will be adequately qualified, timely appointed and an updated list will be maintained. Principal Investigator shall be responsible for leading such team of Personnel. The Trial Site and Principal Investigator are responsible for the services performed by the Personnel and undertake in particular to have the services executed by competent persons. In the event that the Trial Site and/or Principal Investigator use the services of others to conduct the Clinical Investigation pursuant to this Agreement, the Trial Site and Principal Investigator shall be responsible for ensuring that all are appropriate, in compliance with the terms of this Agreement. The Trial Site shall be liable for any breach of this Agreement by the Principal Investigator and/or Personnel.

Principal Investigator and Personnel. The Participating Organisation represents that it is entitled to procure, and the Participating Organisation will procure the services of the Principal Investigator, any and all Sub-Investigators and other Personnel, to fulfil these functions and shall ensure the performance of the obligations of the Principal Investigator, any and all Sub-Investigators and other Personnel set out in Appendix 3 5 and elsewhere in this Agreement. Where the Participating Organisation is not the Principal Investigator’s substantive employer it will notify the Principal Investigator’s substantive employer in a timely way of the Principal Investigator’s his/her proposed involvement in the Non-Interventional StudyClinical Trial. Any financial or other arrangements relating to the Principal Investigator's involvement in the Non-Interventional Study Clinical Trial will be agreed directly between the Participating Organisation and the Principal Investigator’s substantive employer. The Participating Organisation represents that the Principal Investigator holds the necessary registration and has the necessary expertise, time and resources to perform the Non-Interventional Study Clinical Trial and will ensure that the Principal Investigator is made aware of and acknowledges the obligations applicable to the Principal Investigator set out in this Agreement, including but not limited to those set out in Appendix 35. The Participating Organisation shall notify the Sponsor and CRO if the Principal Investigator ceases to be employed by or associated with the Participating Organisation, is erased from the medical register (or equivalent UK professional register where the Principal Investigator is not a medical doctor) or is otherwise sanctioned by an applicable regulatory or other governmental authority, or is otherwise unavailable to continue as Principal Investigator. The Participating Organisation shall use all reasonable endeavours to find a replacement acceptable to both the Sponsor and the Participating Organisationall Parties, subject to the Participating Organisation’s overriding obligations in relation to Non-Interventional Study Clinical Trial Subjects and individual patient care. If no mutually acceptable replacement can be found the Sponsor or CRO may terminate this Agreement pursuant to Clause 14.3. The Participating Organisation shall procure, and shall ensure that the Principal Investigator procures, the performance of the obligations of the Personnel as set out in this Agreement. The Principal Investigator and/or Personnel shall attend any meetings regarding the Non-Interventional Study Clinical Trial as reasonably requested by the Sponsor or CRO (‘“Investigator Meetings’”). Such meetings to be conducted by the Sponsor or CRO to convey or exchange information with the Principal Investigator, all Sub-Investigators or other Personnel to support the effective conduct or close-out of the Non-Interventional StudyClinical Trial. The Participating Organisation agrees that no additional compensation shall be due hereunder for Principal Investigator’s or any other Personnel’s respective participation in Investigator Meetings. The Sponsor or CRO shall reimburse or pay for reasonable pre-approved expenses for attendance at the Investigator Meetings upon receipt of documentation. It is further agreed that any such expenses will be paid at the rate of fair market value (as detailed in line with the applicable ABPI Code of Practice)and Practice) and subject to the documentation evidencing the expenses being in sufficient detail for the Sponsor’s financial reporting purposespurposes of the Party making payment, provided that the required detail does not impose an unreasonable administrative burden upon the Participating Organisation. Such expenses may be publicly reportable. The Participating Organisation represents that it will support the Principal Investigator to make good faith diligent efforts to ensure the completion of all case report forms, where applicable, forms in a timely manner.

Principal Investigator and Personnel. The Participating Organisation represents that it is entitled to procure, and the Participating Organisation will procure the services of the Principal Investigator, any and all Sub-Investigators and other Personnel, to fulfil these functions and shall ensure the performance of the obligations of the Principal Investigator, any and all Sub-Investigators and other Personnel set out in Appendix 3 5 and elsewhere in this Agreement. Where the Participating Organisation is not the Principal Investigator’s substantive employer it will notify the Principal Investigator’s substantive employer in a timely way of the Principal Investigator’s his/her proposed involvement in the Non-Interventional StudyClinical Trial. Any financial or other arrangements relating to the Principal Investigator's involvement in the Non-Interventional Study Clinical Trial will be agreed directly between the Participating Organisation and the Principal Investigator’s substantive employer. The Participating Organisation represents that the Principal Investigator holds the necessary registration and has the necessary expertise, time and resources to perform the Non-Interventional Study Clinical Trial and will ensure that the Principal Investigator is made aware of and acknowledges the obligations applicable to the Principal Investigator set out in this Agreement, including but not limited to those set out in Appendix 35. The Participating Organisation shall notify the Sponsor if the Principal Investigator ceases to be employed by or associated with the Participating Organisation, is erased from the medical register (or equivalent UK professional register where the Principal Investigator is not a medical doctor) or is otherwise sanctioned by an applicable regulatory or other governmental authority, or is otherwise unavailable to continue as Principal Investigator. The Participating Organisation shall use all reasonable endeavours to find a replacement acceptable to both the Sponsor and the Participating Organisation, subject to the Participating Organisation’s overriding obligations in relation to Non-Interventional Study Clinical Trial Subjects and individual patient care. If no mutually acceptable replacement can be found the Sponsor may terminate this Agreement pursuant to Clause 14.3. The Participating Organisation shall procure, and shall ensure that the Principal Investigator procures, the performance of the obligations of the Personnel as set out in this Agreement. The Principal Investigator and/or Personnel shall attend any meetings regarding the Non-Interventional Study Clinical Trial as reasonably requested by the Sponsor (‘“Investigator Meetings’”). Such meetings to be conducted by the Sponsor to convey or exchange information with the Principal Investigator, all Sub-Investigators or other Personnel to support the effective conduct or close-out of the Non-Interventional StudyClinical Trial. The Participating Organisation agrees that no additional compensation shall be due hereunder for Principal Investigator’s or any other Personnel’s respective participation in Investigator Meetings. The Sponsor shall reimburse or pay for reasonable pre-approved expenses for attendance at the Investigator Meetings upon receipt of documentation. It is further agreed that any such expenses will be paid at the rate of fair market value (as detailed in line with the applicable ABPI Code of Practice)and Practice) and subject to the documentation evidencing the expenses being in sufficient detail for the Sponsor’s financial reporting purposes, provided that the required detail does not impose an unreasonable administrative burden upon the Participating Organisation. Such expenses may be publicly reportable. The Participating Organisation represents that it will support the Principal Investigator to make good faith diligent efforts to ensure the completion of all case report forms, where applicable, forms in a timely manner.

Principal Investigator and Personnel. The Participating Organisation Trial Site represents that it is entitled to procure, and the Participating Organisation Trial Site will procure the services of the Principal Investigator, any and all Sub-Investigators and other Personnel, to fulfil these functions and shall ensure the performance of the obligations of the Principal Investigator, any and all Sub-Investigators and other Personnel set out in Appendix 3 5 and elsewhere in this Agreement. Where the Participating Organisation Trial Site is not the Principal Investigator’s substantive employer it will notify the Principal Investigator’s substantive employer in a timely way of the Principal Investigator’s their proposed involvement in the Non-Interventional StudyClinical Investigation. Any financial or other arrangements relating to the Principal Investigator's involvement in the Non-Interventional Study Clinical Investigation will be agreed directly between the Participating Organisation Trial Site and the Principal Investigator’s substantive employer. The Participating Organisation Trial Site represents that the Principal Investigator holds the necessary registration and has the necessary expertise, time and resources to perform the Non-Interventional Study Clinical Investigation and will ensure that the Principal Investigator is made aware of and acknowledges the obligations applicable to the Principal Investigator set out in this Agreement, including but not limited to those set out in Appendix 35. The Participating Organisation Trial Site shall notify the Sponsor and CRO if the Principal Investigator ceases to be employed by or associated with the Participating OrganisationTrial Site, is erased from the medical register (or equivalent UK professional register where the Principal Investigator is not a medical doctor) or is otherwise sanctioned by an applicable regulatory or other governmental authority, or is otherwise unavailable to continue as Principal Investigator. The Participating Organisation Trial Site shall use all reasonable endeavours to find a replacement acceptable to both the Sponsor and the Participating Organisationall Parties, subject to the Participating OrganisationTrial Site’s overriding obligations in relation to Non-Interventional Study Subjects Clinical Investigation Participants and individual patient care. If no mutually acceptable replacement can be found the Sponsor or CRO may terminate this Agreement pursuant to Clause 14.3. The Participating Organisation Trial Site shall procure, and shall ensure that the Principal Investigator procures, the performance of the obligations of the Personnel as set out in this Agreement. The Principal Investigator and/or and / or Personnel shall attend any meetings regarding the Non-Interventional Study Clinical Investigation as reasonably requested by the Sponsor or CRO (‘“Investigator Meetings’”). Such meetings to be conducted by the Sponsor or CRO to convey or exchange information with the Principal Investigator, all Sub-Investigators or other Personnel to support the effective conduct or close-out of the Non-Interventional StudyClinical Investigation. The Participating Organisation Trial Site agrees that no additional compensation shall be due hereunder for Principal Investigator’s or any other Personnel’s respective participation in Investigator Meetings. The Sponsor or CRO shall reimburse or pay for reasonable pre-approved expenses for attendance at the Investigator Meetings upon receipt of documentation. It is further agreed that any such expenses will be paid at the rate of fair market value (as detailed in line with the applicable ABHI Code of Practice)and Ethical Business Practice) and subject to the documentation evidencing the expenses being in sufficient detail for the Sponsor’s financial reporting purposespurposes of the Party making payment, provided that the required detail does not impose an unreasonable administrative burden upon the Participating OrganisationTrial Site. Such expenses may be publicly reportable. The Participating Organisation Trial Site represents that it will support the Principal Investigator to make good faith diligent efforts to ensure the completion of all case report forms, where applicable, forms in a timely manner. The Trial Site through the Principal Investigator may appoint such other persons as the Principal Investigator may deem appropriate as Sub-Investigators or other Personnel to assist in the conduct of the Clinical Investigation. All Personnel will be adequately qualified, timely appointed and an updated list will be maintained. The Principal Investigator shall be responsible for leading such team of Personnel. The Trial Site and Principal Investigator are responsible for the services performed by the Personnel and undertake in particular to have the services executed by competent persons. In the event that the Trial Site and / or Principal Investigator use the services of others to conduct the Clinical Investigation pursuant to this Agreement, the Trial Site and Principal Investigator shall be responsible for ensuring that all are appropriate, in compliance with the terms of this Agreement. The Trial Site shall be liable for any breach of this Agreement by the Principal Investigator and / or Personnel.

Principal Investigator and Personnel. The Participating Organisation Trial Site represents that it is entitled to procure, and the Participating Organisation Trial Site will procure the services of the Principal Investigator, any and all Sub-Investigators and other Personnel, to fulfil these functions and shall ensure the performance of the obligations of the Principal Investigator, any and all Sub-Investigators and other Personnel set out in Appendix 3 5 and elsewhere in this Agreement. Where the Participating Organisation Trial Site is not the Principal Investigator’s substantive employer it will notify the Principal Investigator’s substantive employer in a timely way of the Principal Investigator’s their proposed involvement in the Non-Interventional StudyClinical Trial. Any financial or other arrangements relating to the Principal Investigator's involvement in the Non-Interventional Study Clinical Trial will be agreed directly between the Participating Organisation Trial Site and the Principal Investigator’s substantive employer. The Participating Organisation Trial Site represents that the Principal Investigator holds the necessary registration and has the necessary expertise, time and resources to perform the Non-Interventional Study Clinical Trial and will ensure that the Principal Investigator is made aware of and acknowledges the obligations applicable to the Principal Investigator set out in this Agreement, including but not limited to those set out in Appendix 35. The Participating Organisation Trial Site shall notify the Sponsor and CRO if the Principal Investigator ceases to be employed by or associated with the Participating OrganisationTrial Site, is erased from the medical register (or equivalent UK professional register where the Principal Investigator is not a medical doctor) or is otherwise sanctioned by an applicable regulatory or other governmental authority, or is otherwise unavailable to continue as Principal Investigator. The Participating Organisation Trial Site shall use all reasonable endeavours to find a replacement acceptable to both the Sponsor and the Participating Organisationall Parties, subject to the Participating OrganisationTrial Site’s overriding obligations in relation to Non-Interventional Study Subjects Participants and individual patient care. If no mutually acceptable replacement can be found the Sponsor or CRO may terminate this Agreement pursuant to Clause 14.3. The Participating Organisation Trial Site shall procure, and shall ensure that the Principal Investigator procures, the performance of the obligations of the Personnel as set out in this Agreement. The Principal Investigator and/or and / or Personnel shall attend any meetings regarding the Non-Interventional Study Clinical Trial as reasonably requested by the Sponsor or CRO (‘“Investigator Meetings’”). Such meetings to be conducted by the Sponsor or CRO to convey or exchange information with the Principal Investigator, all Sub-Investigators or other Personnel to support the effective conduct or close-out of the Non-Interventional StudyClinical Trial. The Participating Organisation Trial Site agrees that no additional compensation shall be due hereunder for Principal Investigator’s or any other Personnel’s respective participation in Investigator Meetings. The Sponsor or CRO shall reimburse or pay for reasonable pre-approved expenses for attendance at the Investigator Meetings upon receipt of documentation. It is further agreed that any such expenses will be paid at the rate of fair market value (as detailed in line with the applicable ABPI Code of Practice)and Practice) and subject to the documentation evidencing the expenses being in sufficient detail for the Sponsor’s financial reporting purposespurposes of the Party making payment, provided that the required detail does not impose an unreasonable administrative burden upon the Participating OrganisationTrial Site. Such expenses may be publicly reportable. The Participating Organisation Trial Site represents that it will support the Principal Investigator to make good faith diligent efforts to ensure the completion of all case report forms, where applicable, forms in a timely manner. The Trial Site through the Principal Investigator may appoint such other persons as the Principal Investigator may deem appropriate as Sub-Investigators or other Personnel to assist in the conduct of the Clinical Trial. All Personnel will be adequately qualified, timely appointed and an updated list will be maintained. Principal Investigator shall be responsible for leading such team of Personnel. The Trial Site and Principal Investigator are responsible for the services performed by the Personnel and undertake in particular to have the services executed by competent persons. In the event that the Trial Site and / or Principal Investigator use the services of others to conduct the Clinical Trial pursuant to this Agreement, the Trial Site and Principal Investigator shall be responsible for ensuring that all are appropriate, in compliance with the terms of this Agreement. The Trial Site shall be liable for any breach of this Agreement by the Principal Investigator and / or Personnel.

Principal Investigator and Personnel. The Participating Organisation Trial Site represents that it is entitled to procure, and the Participating Organisation Trial Site will procure the services of the Principal Investigator, any and all Sub-Investigators and other Personnel, to fulfil these functions and shall ensure the performance of the obligations of the Principal Investigator, any and all Sub-Investigators and other Personnel set out in Appendix 3 5 and elsewhere in this Agreement. Where the Participating Organisation Trial Site is not the Principal Investigator’s substantive employer it will notify the Principal Investigator’s substantive employer in a timely way of the Principal Investigator’s their proposed involvement in the Non-Interventional StudyClinical Trial. Any financial or other arrangements relating to the Principal Investigator's involvement in the Non-Interventional Study Clinical Trial will be agreed directly between the Participating Organisation Trial Site and the Principal Investigator’s substantive employer. The Participating Organisation Trial Site represents that the Principal Investigator holds the necessary registration and has the necessary expertise, time and resources to perform the Non-Interventional Study Clinical Trial and will ensure that the Principal Investigator is made aware of and acknowledges the obligations applicable to the Principal Investigator set out in this Agreement, including but not limited to those set out in Appendix 35. The Participating Organisation Trial Site shall notify the Sponsor and CRO if the Principal Investigator ceases to be employed by or associated with the Participating OrganisationTrial Site, is erased from the medical register (or equivalent UK professional register where the Principal Investigator is not a medical doctor) or is otherwise sanctioned by an applicable regulatory or other governmental authority, or is otherwise unavailable to continue as Principal Investigator. The Participating Organisation Trial Site shall use all reasonable endeavours to find a replacement acceptable to both the Sponsor and the Participating Organisationall Parties, subject to the Participating OrganisationTrial Site’s overriding obligations in relation to Non-Interventional Study Clinical Trial Subjects and individual patient care. If no mutually acceptable replacement can be found the Sponsor or CRO may terminate this Agreement pursuant to Clause 14.3. The Participating Organisation Trial Site shall procure, and shall ensure that the Principal Investigator procures, the performance of the obligations of the Personnel as set out in this Agreement. The Principal Investigator and/or Personnel shall attend any meetings regarding the Non-Interventional Study Clinical Trial as reasonably requested by the Sponsor or CRO (‘“Investigator Meetings’”). Such meetings to be conducted by the Sponsor or CRO to convey or exchange information with the Principal Investigator, all Sub-Investigators or other Personnel to support the effective conduct or close-out of the Non-Interventional StudyClinical Trial. The Participating Organisation Trial Site agrees that no additional compensation shall be due hereunder for Principal Investigator’s or any other Personnel’s respective participation in Investigator Meetings. The Sponsor or CRO shall reimburse or pay for reasonable pre-approved expenses for attendance at the Investigator Meetings upon receipt of documentation. It is further agreed that any such expenses will be paid at the rate of fair market value (as detailed in line with the applicable ABPI Code of Practice)and Practice) and subject to the documentation evidencing the expenses being in sufficient detail for the Sponsor’s financial reporting purposespurposes of the Party making payment, provided that the required detail does not impose an unreasonable administrative burden upon the Participating OrganisationTrial Site. Such expenses may be publicly reportable. The Participating Organisation Trial Site represents that it will support the Principal Investigator to make good faith diligent efforts to ensure the completion of all case report forms, where applicable, forms in a timely manner. The Trial Site through the Principal Investigator may appoint such other persons as the Principal Investigator may deem appropriate as Sub-Investigators or other Personnel to assist in the conduct of the Clinical Trial. All Personnel will be adequately qualified, timely appointed and an updated list will be maintained. Principal Investigator shall be responsible for leading such team of Personnel. The Trial Site and Principal Investigator are responsible for the services performed by the Personnel and undertake in particular to have the services executed by competent persons. In the event that the Trial Site and/or Principal Investigator use the services of others to conduct the Clinical Trial pursuant to this Agreement, the Trial Site and Principal Investigator shall be responsible for ensuring that all are appropriate, in compliance with the terms of this Agreement. The Trial Site shall be liable for any breach of this Agreement by the Principal Investigator and/or Personnel.

Principal Investigator and Personnel. The Participating Organisation represents that it is entitled to procure, and the Participating Organisation will procure the services of the Principal Investigator, any and all Sub-Investigators and other Personnel, to fulfil these functions and shall ensure the performance of the obligations of the Principal Investigator, any and all Sub-Investigators and other Personnel set out in Appendix 3 5 and elsewhere in this Agreement. Where the Participating Organisation is not the Principal Investigator’s substantive employer it will notify the Principal Investigator’s substantive employer in a timely way of the Principal Investigator’s his/her proposed involvement in the Non-Interventional StudyClinical Trial. Any financial or other arrangements relating to the Principal Investigator's involvement in the Non-Interventional Study Clinical Trial will be agreed directly between the Participating Organisation and the Principal Investigator’s substantive employer. The Participating Organisation represents that the Principal Investigator holds the necessary registration and has the necessary expertise, time and resources to perform the Non-Interventional Study Clinical Trial and will ensure that the Principal Investigator is made aware of and acknowledges the obligations applicable to the Principal Investigator set out in this Agreement, including but not limited to those set out in Appendix 35. The Participating Organisation shall notify the Sponsor and CRO if the Principal Investigator ceases to be employed by or associated with the Participating Organisation, is erased from the medical register (or equivalent UK professional register where the Principal Investigator is not a medical doctor) or is otherwise sanctioned by an applicable regulatory or other governmental authority, or is otherwise unavailable to continue as Principal Investigator. The Participating Organisation shall use all reasonable endeavours to find a replacement acceptable to both the Sponsor and the Participating Organisationall Parties, subject to the Participating Organisation’s overriding obligations in relation to Non-Interventional Study Clinical Trial Subjects and individual patient care. If no mutually acceptable replacement can be found the Sponsor or CRO may terminate this Agreement pursuant to Clause 14.3. The Participating Organisation shall procure, and shall ensure that the Principal Investigator procures, the performance of the obligations of the Personnel as set out in this Agreement. The Principal Investigator and/or Personnel shall attend any meetings regarding the Non-Interventional Study Clinical Trial as reasonably requested by the Sponsor or CRO (‘“Investigator Meetings’”). Such meetings to be conducted by the Sponsor or CRO to convey or exchange information with the Principal Investigator, all Sub-Investigators or other Personnel to support the effective conduct or close-out of the Non-Interventional StudyClinical Trial. The Participating Organisation agrees that no additional compensation shall be due hereunder for Principal Investigator’s or any other Personnel’s respective participation in Investigator Meetings. The Sponsor or CRO shall reimburse or pay for reasonable pre-approved expenses for attendance at the Investigator Meetings upon receipt of documentation. It is further agreed that any such expenses will be paid at the rate of fair market value (as detailed in line with the applicable ABPI Code of Practice)and Practice) and subject to the documentation evidencing the expenses being in sufficient detail for the Sponsor’s financial reporting purposespurposes of the Party making payment, provided that the required detail does not impose an unreasonable administrative burden upon the Participating Organisation. Such expenses may be publicly reportable. The Participating Organisation represents that it will support the Principal Investigator to make good faith diligent efforts to ensure the completion of all case report forms, where applicable, forms in a timely manner. The Participating Organisation through the Principal Investigator may appoint such other persons as the Principal Investigator may deem appropriate as Sub-Investigators or other Personnel to assist in the conduct of the Clinical Trial. All Personnel will be adequately qualified, timely appointed and an updated list will be maintained. The Principal Investigator shall be responsible for leading such team of Personnel. The Participating Organisation and Principal Investigator are responsible for the services performed by the Personnel and undertake in particular to have the services executed by competent persons. In the event that the Participating Organisation and/or Principal Investigator use the services of others to conduct the Clinical Trial pursuant to this Agreement, the Participating Organisation and Principal Investigator shall be responsible for ensuring that all are appropriate, in compliance with the terms of this Agreement. The Participating Organisation shall be liable for any breach of this Agreement by the Principal Investigator and/or Personnel.

Principal Investigator and Personnel. The Participating Organisation Other Trial Site represents that it is entitled to procureprocure and will procure the services of the Sub-Investigator(s) to fulfil the functions required in this Agreement, as required by the Protocol, and as instructed by the Participating Organisation Principal Investigator, as outlined in Appendix 2. The Lead Trial Site represents that it is entitled to procure and will procure the services of the Principal Investigator, any and all Sub-Investigators and other Personnel, to fulfil these functions and shall ensure the performance of the obligations of the Principal Investigator, any and all Sub-Investigators and other Personnel set out in Appendix 3 and elsewhere in this Agreement. Where the Participating Organisation is not the Principal Investigator’s substantive employer it will notify the Principal Investigator’s substantive employer in a timely way of the Principal Investigator’s proposed involvement in the Non-Interventional Study. Any financial or other arrangements relating to the Principal Investigator's involvement in the Non-Interventional Study will be agreed directly between the Participating Organisation Investigator [[FOR OPTIONAL USE ONLY WITH WELSH TRIAL SITES AND OTHER TRIAL SITES] and the Principal Investigator’s substantive employer. The Participating Organisation Central Management Function]], and represents that the Principal Investigator holds the necessary registration and has the necessary expertise, time and resources to perform the Non-Interventional Study and will Clinical Trial. The Lead Trial Site shall ensure that the Principal Investigator is made aware of and acknowledges the obligations applicable to the Principal Investigator Investigator, as set out in this Agreement, including but not limited to those set out in Appendix 3. The Participating Organisation shall notify Other Trial Site represents that the Sponsor if Sub-Investigator and Personnel have the Principal Investigator ceases necessary time and resources to be employed by or associated with perform the Participating Organisation, is erased from the medical register (or equivalent UK professional register where the Principal Investigator is not a medical doctor) or is otherwise sanctioned by an applicable regulatory or other governmental authority, or is otherwise unavailable to continue as Principal InvestigatorClinical Trial. The Participating Organisation shall use all reasonable endeavours to find a replacement acceptable to both the Sponsor and the Participating Organisation, subject to the Participating Organisation’s overriding obligations in relation to Non-Interventional Study Subjects and individual patient care. If no mutually acceptable replacement can be found the Sponsor may terminate this Agreement pursuant to Clause 14.3. The Participating Organisation shall procure, and Other Trial Site shall ensure that the Principal Sub-Investigator procures, the performance of and Personnel are made aware and acknowledge the obligations of the Personnel application to them as set out in this Agreement, including but not limited to those set out in Appendix 2. The Principal Other Trial Site will ensure that the Sub-Investigator and/or other Personnel shall as appropriate, attend any meetings regarding the Non-Interventional Study Clinical Trial as reasonably requested by the Sponsor Lead Trial Site (‘Investigator “Clinical Trial Meetings’”). Such meetings to be conducted by the Sponsor to convey or exchange information with the Principal Investigator, all Sub-Investigators or other Personnel to support the effective conduct or close-out of the Non-Interventional Study. The Participating Organisation Other Trial Site agrees that no additional compensation shall be due hereunder for Principal the Sub-Investigator’s or any other Personnel’s respective participation in Investigator any Clinical Trial Meetings. [The Sponsor Lead Trial Site shall reimburse or pay for reasonable pre-approved expenses for attendance at the Investigator Clinical Trial Meetings upon receipt of documentationsufficient evidence. It is further agreed that any such expenses will be paid at the rate of fair market value (as detailed in the applicable Code of Practice)and subject to the documentation evidencing the expenses being in sufficient detail for the Sponsor’s financial reporting purposes, provided that the required detail does not impose an unreasonable administrative burden upon the Participating Organisationvalue. Such expenses may be publicly reportable. DELETE IF NOT APPLICABLE] The Participating Organisation Other Trial Site represents that that, where applicable, it will support the Principal Sub Investigator and Personnel to make good faith diligent efforts to ensure the completion of all case report forms, where applicable, forms (CRFs) in a timely mannermanner under the instruction and oversight of the Principal Investigator.

Principal Investigator and Personnel. The Participating Organisation represents that it is entitled to procure, and the Participating Organisation will procure the services of the Principal Investigator, any and all Sub-Investigators and other Personnel, to fulfil these functions and shall ensure the performance of the obligations of the Principal Investigator, any and all Sub-Investigators and other Personnel set out in Appendix 3 and elsewhere in this Agreement. Where the Participating Organisation is not the Principal Investigator’s substantive employer it will notify the Principal Investigator’s substantive employer in a timely way of the Principal Investigator’s proposed involvement in the Non-Interventional Study. Any financial or other arrangements relating to the Principal Investigator's involvement in the Non-Interventional Study will be agreed directly between the Participating Organisation and the Principal Investigator’s substantive employer. The Participating Organisation represents that the Principal Investigator holds the necessary registration and has the necessary expertise, time and resources to perform the Non-Interventional Study and will ensure that the Principal Investigator is made aware of and acknowledges the obligations applicable to the Principal Investigator set out in this Agreement, including but not limited to those set out in Appendix 3. The Participating Organisation shall notify the Sponsor if the Principal Investigator ceases to be employed by or associated with the Participating Organisation, is erased from the medical register (or equivalent UK professional register where the Principal Investigator is not a medical doctor) or is otherwise sanctioned by an applicable regulatory or other governmental authority, or is otherwise unavailable to continue as Principal Investigator. The Participating Organisation shall use all reasonable endeavours to find a replacement acceptable to both the Sponsor and the Participating Organisation, subject to the Participating Organisation’s overriding obligations in relation to Non-Interventional Study Subjects Participants and individual patient care. If no mutually acceptable replacement can be found the Sponsor may terminate this Agreement pursuant to Clause 14.3. The Participating Organisation shall procure, and shall ensure that the Principal Investigator procures, the performance of the obligations of the Personnel as set out in this Agreement. The Principal Investigator and/or and / or Personnel shall attend any meetings regarding the Non-Interventional Study as reasonably requested by the Sponsor (‘“Investigator Meetings’”). Such meetings to be conducted by the Sponsor to convey or exchange information with the Principal Investigator, all Sub-Investigators or other Personnel to support the effective conduct or close-out of the Non-Interventional Study. The Participating Organisation agrees that no additional compensation shall be due hereunder for Principal Investigator’s or any other Personnel’s respective participation in Investigator Meetings. The Sponsor shall reimburse or pay for reasonable pre-approved expenses for attendance at the Investigator Meetings upon receipt of documentation. It is further agreed that any such expenses will be paid at the rate of fair market value (as detailed in the applicable Code of Practice)and Practice) and subject to the documentation evidencing the expenses being in sufficient detail for the Sponsor’s financial reporting purposes, provided that the required detail does not impose an unreasonable administrative burden upon the Participating Organisation. Such expenses may be publicly reportable. The Participating Organisation represents that it will support the Principal Investigator to make good faith diligent efforts to ensure the completion of all case report forms, where applicable, in a timely manner.

Principal Investigator and Personnel. The Participating Organisation represents Trial Site and the Principal Investigator represent that it is they are entitled to procure, and the Participating Organisation will procure the services of the Principal Investigator, any and all Sub-Investigators and other Personnel, to fulfil these functions and shall ensure the performance of the obligations of the Principal Investigator, any and all Sub-Investigators and other Personnel set out in Appendix 3 5 and elsewhere in this Agreement. Where the Participating Organisation is not the Principal Investigator’s substantive employer it will notify the Principal Investigator’s substantive employer in a timely way of the Principal Investigator’s proposed involvement in the Non-Interventional Study. Any financial or other arrangements relating to the Principal Investigator's involvement in the Non-Interventional Study will be agreed directly between the Participating Organisation The Trial Site and the Principal Investigator’s substantive employer. The Participating Organisation represents Investigator each represent that the Principal Investigator holds the necessary registration and has the necessary expertise, time and resources to perform the Non-Interventional Study Clinical Trial and will ensure that the Principal Investigator is made aware of and acknowledges the obligations applicable to the Principal Investigator set out in this Agreement, including but not limited to those set out in Appendix 35. The Participating Organisation Trial Site and the Principal Investigator shall notify the Sponsor if the Principal Investigator ceases to be employed by or associated with the Participating OrganisationTrial Site, is erased from the medical register (or equivalent UK professional register where the Principal Investigator is not a medical doctor) or is otherwise sanctioned by an applicable regulatory or other governmental authority, or is otherwise unavailable to continue as Principal Investigator. The Participating Organisation Sponsor shall use all reasonable endeavours then be entitled to find a replacement acceptable to both the Sponsor and the Participating Organisation, subject to the Participating Organisation’s overriding obligations in relation to Non-Interventional Study Subjects and individual patient care. If no mutually acceptable replacement can be found the Sponsor may terminate this Agreement pursuant to Clause 14.3. The Participating Organisation shall procure, Trial Site and shall ensure that the Principal Investigator procures, shall procure the performance of the obligations of the Personnel as set out in this Agreement. The Principal Investigator and/or and / or Personnel shall attend any meetings regarding the Non-Interventional Study Clinical Trial as reasonably requested by the Sponsor (‘“Investigator Meetings’”). Such meetings to be conducted by the Sponsor to convey or exchange information with the Principal Investigator, all Sub-Investigators or other Personnel to support the effective conduct or close-out of the Non-Interventional StudyClinical Trial. The Participating Organisation Trial Site agrees that no additional compensation shall be due hereunder for Principal Investigator’s or any other Personnel’s respective participation in Investigator Meetings. The Sponsor shall reimburse or pay for reasonable pre-approved expenses for attendance at the Investigator Meetings upon receipt of documentation. It is further agreed that any such expenses will be paid at the rate of fair market value (as detailed in line with the applicable ABPI Code of Practice)and Practice) and subject to the documentation evidencing the expenses being in sufficient detail for the Sponsor’s financial reporting purposes, provided that the required detail does not impose an unreasonable administrative burden upon the Participating OrganisationTrial Site. Such expenses may be publicly reportable. The Participating Organisation Principal Investigator represents that it they will support the Principal Investigator to make good faith diligent efforts to ensure the completion of all case report forms, where applicable, forms in a timely manner. The Principal Investigator may appoint such other persons, as they may deem appropriate, as Sub-Investigators or other Personnel to assist in the conduct of the Clinical Trial. All Personnel will be adequately qualified, timely appointed and an updated list will be maintained. Principal Investigator shall be responsible for leading such team of Personnel. The Trial Site and Principal Investigator are responsible for the services performed by the Personnel and undertake in particular to have the services executed by competent persons. In the event that the Trial Site and / or Principal Investigator use the services of others to conduct the Clinical Trial pursuant to this Agreement, the Trial Site and Principal Investigator shall be responsible for ensuring that all are appropriate, in compliance with the terms of this Agreement. The Trial Site and the Principal Investigator shall be liable for any breach of this Agreement by the Principal Investigator and / or Personnel.

Principal Investigator and Personnel. The Participating Organisation Other Trial Site represents that it is entitled to procureprocure and will procure the services of the Sub-Investigator(s) to fulfil the functions required in this Agreement, as required by the Protocol, and as instructed by the Participating Organisation Principal Investigator, as outlined in Appendix 2. The Lead Trial Site represents that it is entitled to procure and will procure the services of the Principal Investigator, any and all Sub-Investigators and other Personnel, to fulfil these functions and shall ensure the performance of the obligations of the Principal Investigator, any and all Sub-Investigators and other Personnel set out in Appendix 3 and elsewhere in this Agreement. Where the Participating Organisation is not the Principal Investigator’s substantive employer it will notify the Principal Investigator’s substantive employer in a timely way of the Principal Investigator’s proposed involvement in the Non-Interventional Study. Any financial or other arrangements relating to the Principal Investigator's involvement in the Non-Interventional Study will be agreed directly between the Participating Organisation and the Principal Investigator’s substantive employer. The Participating Organisation represents that the Principal Investigator holds the necessary registration and has the necessary expertise, time and resources to perform the Non-Interventional Study and will Clinical Trial. The Lead Trial Site shall ensure that the Principal Investigator is made aware of and acknowledges the obligations applicable to the Principal Investigator Investigator, as set out in this Agreement, including but not limited to those set out in Appendix 3. The Participating Organisation shall notify Other Trial Site represents that the Sponsor if Sub-Investigator and Personnel have the Principal Investigator ceases necessary time and resources to be employed by or associated with perform the Participating Organisation, is erased from the medical register (or equivalent UK professional register where the Principal Investigator is not a medical doctor) or is otherwise sanctioned by an applicable regulatory or other governmental authority, or is otherwise unavailable to continue as Principal InvestigatorClinical Trial. The Participating Organisation shall use all reasonable endeavours to find a replacement acceptable to both the Sponsor and the Participating Organisation, subject to the Participating Organisation’s overriding obligations in relation to Non-Interventional Study Subjects and individual patient care. If no mutually acceptable replacement can be found the Sponsor may terminate this Agreement pursuant to Clause 14.3. The Participating Organisation shall procure, and Other Trial Site shall ensure that the Principal Sub-Investigator procures, the performance of and Personnel are made aware and acknowledge the obligations of the Personnel application to them as set out in this Agreement, including but not limited to those set out in Appendix 2. The Principal Other Trial Site will ensure that the Sub-Investigator and/or and / or other Personnel shall as appropriate, attend any meetings regarding the Non-Interventional Study Clinical Trial as reasonably requested by the Sponsor Lead Trial Site (‘Investigator “Clinical Trial Meetings’”). Such meetings to be conducted by the Sponsor to convey or exchange information with the Principal Investigator, all Sub-Investigators or other Personnel to support the effective conduct or close-out of the Non-Interventional Study. The Participating Organisation Other Trial Site agrees that no additional compensation shall be due hereunder for Principal the Sub-Investigator’s or any other Personnel’s respective participation in Investigator any Clinical Trial Meetings. [The Sponsor Lead Trial Site shall reimburse or pay for reasonable pre-approved expenses for attendance at the Investigator Clinical Trial Meetings upon receipt of documentationsufficient evidence. It is further agreed that any such expenses will be paid at the rate of fair market value (as detailed in the applicable Code of Practice)and subject to the documentation evidencing the expenses being in sufficient detail for the Sponsor’s financial reporting purposes, provided that the required detail does not impose an unreasonable administrative burden upon the Participating Organisationvalue. Such expenses may be publicly reportable. DELETE IF NOT APPLICABLE] The Participating Organisation Other Trial Site represents that that, where applicable, it will support the Principal Sub Investigator and Personnel to make good faith diligent efforts to ensure the completion of all case report forms, where applicable, forms (CRFs) in a timely mannermanner under the instruction and oversight of the Principal Investigator. Clinical Trial Governance The Lead Trial Site shall inform the Other Trial Site of the name and telephone number of the Trial Monitor and the name of the person who will be available as a point of contact. The Lead Trial Site shall also provide the Principal Investigator with an emergency telephone number to enable serious adverse event reporting at any time. To the extent applicable to each, the Parties shall comply with, and shall ensure that their respective Personnel who are providing any manner of service related to the Clinical Trial comply with, all relevant laws including but not limited to: The Human Rights Act 1998; The Data Protection Laws and Guidance; The Human Tissue Act 2004 or the Human Tissue (Scotland) Act 2006, to be determined in accordance with the place of constitution of the Trial Site; The Medicines Act 1968; The Human Medicines Regulations 2012; The Medicines for Human Use (Clinical Trial) Regulations 2004; The Bribery Act 2010; Relevant law having effect by virtue of ss2-4 of the European Union (Withdrawal) Act 2018; (In Northern Ireland) laws of the European Union having effect as a result of the Protocol on Ireland/Northern Ireland. The Parties shall comply with, and shall ensure that their respective Personnel who are providing any manner of service related to the Clinical Trial comply with, all relevant guidance relating to medicines and clinical trials from time to time in force, including but not limited to: the ICH-GCP; GMP; GVP; the World Medical Association Declaration of Helsinki entitled, “Ethical Principles for Medical Research Involving Human Subjects (1996)”; the Research Governance Framework; the UK Research and Innovation policies and principles entitled, “Human Biological Samples”; [DELETE IF NOT APPLICABLE – the ethical principles set out in WHA63.22 (xxxx://xxx.xxx.xxx/transplantation/en/) with regard to the Clinical Trial.] In addition, where the Clinical Trial is conducted as part of an IND, the Other Trial Site will comply with any other relevant requirements notified by the Lead Trial Site to the Other Trial Site. The Lead Trial Site represents that the Sponsor has committed to comply with the ABPI Clinical Trial Compensation Guidelines. The Parties shall ensure that any members of their respective Personnel joining the Clinical Trial following the initiation of the Clinical Trial, undertake any such appropriate training as the Lead Trial Site or Principal Investigator may consider necessary for the conduct of the Clinical Trial, including but not limited to the training and provision of information given during Investigator Meetings.

Principal Investigator and Personnel. The Participating Organisation Service Provider represents that it is entitled to procure, procure and the Participating Organisation will procure the services of Sub-Investigator and other Personnel to fulfil the functions required in this Agreement and has the necessary expertise, time and resources to perform the Clinical Trial, as required by the Protocol, and instructed by the Principal Investigator outlined in Appendix 2. The Investigator Site represents that it is entitled to procure and will procure the Principal Investigator, any and all Sub-Investigators and other Personnel, to fulfil these functions and shall ensure the performance of the obligations of the Principal Investigator, any and all Sub-Investigators and other Personnel set out in Appendix 3 and elsewhere in this Agreement. Where the Participating Organisation is not the Principal Investigator’s substantive employer it will notify the Principal Investigator’s substantive employer in a timely way of the Principal Investigator’s proposed involvement in the Non-Interventional Study. Any financial or other arrangements relating to the Principal Investigator's involvement in the Non-Interventional Study will be agreed directly between the Participating Organisation and the Principal Investigator’s substantive employer. The Participating Organisation represents that the Principal Investigator holds the necessary registration and has the necessary expertise, time and resources to perform the Non-Interventional Study and will Clinical Trial. The Investigator Site shall ensure that the Principal Investigator is made aware of and acknowledges the obligations applicable to the Principal Investigator him as set out in this Agreement, including but not limited to those set out in Appendix 3. The Participating Organisation shall notify Service Provider represents that it is entitled to procure and will procure the Sponsor if Personnel, and represents that the Principal Investigator ceases Personnel hold the necessary registration and have the necessary expertise, time and resources to be employed by or associated with perform the Participating Organisation, is erased from the medical register (or equivalent UK professional register where the Principal Investigator is not a medical doctor) or is otherwise sanctioned by an applicable regulatory or other governmental authority, or is otherwise unavailable to continue as Principal InvestigatorClinical Trial. The Participating Organisation shall use all reasonable endeavours to find a replacement acceptable to both the Sponsor and the Participating Organisation, subject to the Participating Organisation’s overriding obligations in relation to Non-Interventional Study Subjects and individual patient care. If no mutually acceptable replacement can be found the Sponsor may terminate this Agreement pursuant to Clause 14.3. The Participating Organisation shall procure, and Service Provider shall ensure that the Principal Investigator procures, the performance of Personnel are made aware and acknowledge the obligations of the Personnel application to them as set out in this Agreement, including but not limited to those set out in Appendix 2. The Principal Service Provider must ensure the Sub-Investigator and/or other Personnel shall as appropriate, attend any meetings regarding the Non-Interventional Study Clinical Trial as reasonably requested by the Sponsor Investigator Site (‘Investigator “Clinical Trial Meetings’”). Such meetings to be conducted by the Sponsor to convey or exchange information with the Principal Investigator, all Sub-Investigators or other Personnel to support the effective conduct or close-out of the Non-Interventional Study. The Participating Organisation Service Provider agrees that no additional compensation shall be due hereunder for Principal the Sub-Investigator’s or any other Personnel’s respective participation in Investigator any Clinical Trial Meetings. [The Sponsor Investigator Site shall reimburse or pay for reasonable pre-approved expenses for attendance at the Investigator Clinical Trial Meetings upon receipt of documentationsufficient evidence. It is further agreed that any such expenses will be paid at the rate of fair market value (as detailed in the applicable Code of Practice)and subject to the documentation evidencing the expenses being in sufficient detail for the Sponsor’s financial reporting purposes, provided that the required detail does not impose an unreasonable administrative burden upon the Participating Organisationvalue. Such expenses may be publicly reportable. DELETE IF NOT APPLICABLE] The Participating Organisation Service Provider represents that it will support the Principal Sub Investigator and Personnel to make good faith diligent efforts to ensure the completion of all case report forms, where applicable, forms in a timely mannermanner under the instruction and oversight of the Principal Investigator.

Principal Investigator and Personnel. The Participating Organisation represents that it is entitled to procure, and the Participating Organisation will procure the services of the Principal Investigator, any and all Sub-Investigators and other Personnel, to fulfil these functions and shall ensure the performance of the obligations of the Principal Investigator, any and all Sub-Investigators and other Personnel set out in Appendix 3 and elsewhere in this Agreement. Where the Participating Organisation is not the Principal Investigator’s substantive employer it will notify the Principal Investigator’s substantive employer in a timely way of the Principal Investigator’s proposed involvement in the Non-Interventional Study. Any financial or other arrangements relating to the Principal Investigator's involvement in the Non-Interventional Study will be agreed directly between the Participating Organisation and the Principal Investigator’s substantive employer. The Participating Organisation represents that the Principal Investigator holds the necessary registration and has the necessary expertise, time and resources to perform the Non-Interventional Study and will ensure that the Principal Investigator is made aware of and acknowledges the obligations applicable to the Principal Investigator set out in this Agreement, including but not limited to those set out in Appendix 3. The Participating Organisation shall notify the Sponsor and CRO if the Principal Investigator ceases to be employed by or associated with the Participating Organisation, is erased from the medical register (or equivalent UK professional register where the Principal Investigator is not a medical doctor) or is otherwise sanctioned by an applicable regulatory or other governmental authority, or is otherwise unavailable to continue as Principal Investigator. The Participating Organisation shall use all reasonable endeavours to find a replacement acceptable to both the Sponsor and the Participating Organisationall Parties, subject to the Participating Organisation’s overriding obligations in relation to Non-Interventional Study Subjects Participants and individual patient care. If no mutually acceptable replacement can be found the Sponsor or CRO may terminate this Agreement pursuant to Clause 14.3. The Participating Organisation shall procure, and shall ensure that the Principal Investigator procures, the performance of the obligations of the Personnel as set out in this Agreement. The Principal Investigator and/or and / or Personnel shall attend any meetings regarding the Non-Interventional Study as reasonably requested by the Sponsor or CRO (‘“Investigator Meetings’”). Such meetings to be conducted by the Sponsor or CRO to convey or exchange information with the Principal Investigator, all Sub-Investigators or other Personnel to support the effective conduct or close-out of the Non-Interventional Study. The Participating Organisation agrees that no additional compensation shall be due hereunder for Principal Investigator’s or any other Personnel’s respective participation in Investigator Meetings. The Sponsor or CRO shall reimburse or pay for reasonable pre-approved expenses for attendance at the Investigator Meetings upon receipt of documentation. It is further agreed that any such expenses will be paid at the rate of fair market value (as detailed in the applicable Code of Practice)and Practice) and subject to the documentation evidencing the expenses being in sufficient detail for the Sponsor’s financial reporting purposespurposes of the Party making payment, provided that the required detail does not impose an unreasonable administrative burden upon the Participating Organisation. Such expenses may be publicly reportable. The Participating Organisation represents that it will support the Principal Investigator to make good faith diligent efforts to ensure the completion of all case report forms, where applicable, in a timely manner.

Principal Investigator and Personnel. The Participating Organisation represents that it is entitled to procure, and the Participating Organisation will procure the services of the Principal Investigator, any and all Sub-Investigators and other Personnel, to fulfil these functions and shall ensure the performance of the obligations of the Principal Investigator, any and all Sub-Investigators and other Personnel set out in Appendix 3 and elsewhere in this Agreement. Where the Participating Organisation is not the Principal Investigator’s substantive employer it will notify the Principal Investigator’s substantive employer in a timely way of the Principal Investigator’s his/her proposed involvement in the Non-Interventional StudyClinical Trial. Any financial or other arrangements relating to the Principal Investigator's involvement in the Non-Interventional Study Clinical Trial will be agreed directly between the Participating Organisation and the Principal Investigator’s substantive employer. The Participating Organisation represents that the Principal Investigator holds the necessary registration and has the necessary expertise, time and resources to perform the Non-Interventional Study Clinical Trial and will ensure that the Principal Investigator is made aware of and acknowledges the obligations applicable to the Principal Investigator set out in this Agreement, including but not limited to those set out in Appendix 3. The Participating Organisation shall notify the Sponsor and CRO if the Principal Investigator ceases to be employed by or associated with the Participating Organisation, is erased from the register of medical register practitioners (or equivalent UK Irish professional register where the Principal Investigator is not a medical doctor) or is otherwise sanctioned by an applicable regulatory or other governmental authority, or is otherwise unavailable to continue as Principal Investigator. The Participating Organisation shall use all reasonable endeavours to find a replacement acceptable to both the Sponsor and the Participating Organisationall Parties, subject to the Participating Organisation’s overriding obligations in relation to Non-Interventional Study Clinical Trial Subjects and individual patient care. If no mutually acceptable replacement can be found the Sponsor or CRO may terminate this Agreement pursuant to Clause 14.3. The Participating Organisation shall procure, and shall ensure that the Principal Investigator procures, the performance of the obligations of the Personnel as set out in this Agreement. The Principal Investigator and/or Personnel shall attend any meetings regarding the Non-Interventional Study Clinical Trial as reasonably requested by the Sponsor or CRO (‘“Investigator Meetings’”). Such meetings to be conducted by the Sponsor or CRO to convey or exchange information with the Principal Investigator, all Sub-Investigators or other Personnel to support the effective conduct or close-out of the Non-Interventional StudyClinical Trial. The Participating Organisation agrees that no additional compensation shall be due hereunder for Principal Investigator’s or any other Personnel’s respective participation in Investigator Meetings. The Sponsor or CRO shall reimburse or pay for reasonable pre-approved expenses for attendance at the Investigator Meetings upon receipt of documentation. It is further agreed that any such expenses will be paid at the rate of fair market value (as detailed in line with the applicable IPHA Code of Practice)and Practice) and subject to the documentation evidencing the expenses being in sufficient detail for the Sponsor’s financial reporting purposespurposes of the Party making payment, provided that the required detail does not impose an unreasonable administrative burden upon the Participating Organisation. Such expenses may be publicly reportable. The Participating Organisation represents that it will support the Principal Investigator to make good faith diligent efforts to ensure the completion of all case report forms, where applicable, forms in a timely manner. The Participating Organisation through the Principal Investigator may appoint such other persons as the Principal Investigator may deem appropriate as Sub-Investigators or other Personnel to assist in the conduct of the Clinical Trial. All Personnel will be adequately qualified, timely appointed and an updated list will be maintained. Principal Investigator shall be responsible for leading such team of Personnel. The Participating Organisation and Principal Investigator are responsible for the services performed by the Personnel and undertake in particular to have the services executed by competent persons. In the event that the Participating Organisation and/or Principal Investigator use the services of others to conduct the Clinical Trial pursuant to this Agreement, the Participating Organisation and Principal Investigator shall be responsible for ensuring that all are appropriate, in compliance with the terms of this Agreement. The Participating Organisation shall be liable for any breach of this Agreement by the Principal Investigator and/or Personnel.

Principal Investigator and Personnel. The Participating Organisation Trial Site represents that it is entitled to procure, and the Participating Organisation Trial Site will procure the services of the Principal Investigator, any and all Sub-Investigators and other Personnel, to fulfil these functions and shall ensure the performance of the obligations of the Principal Investigator, any and all Sub-Investigators and other Personnel set out in Appendix 3 5 and elsewhere in this Agreement. Where the Participating Organisation Trial Site is not the Principal Investigator’s substantive employer it will notify the Principal Investigator’s substantive employer in a timely way of the Principal Investigator’s their proposed involvement in the Non-Interventional StudyClinical Trial. Any financial or other arrangements relating to the Principal Investigator's involvement in the Non-Interventional Study Clinical Trial will be agreed directly between the Participating Organisation Trial Site and the Principal Investigator’s substantive employer. The Participating Organisation Trial Site represents that the Principal Investigator holds the necessary registration and has the necessary expertise, time and resources to perform the Non-Interventional Study Clinical Trial and will ensure that the Principal Investigator is made aware of and acknowledges the obligations applicable to the Principal Investigator set out in this Agreement, including but not limited to those set out in Appendix 35. The Participating Organisation Trial Site shall notify the Sponsor if the Principal Investigator ceases to be employed by or associated with the Participating OrganisationTrial Site, is erased from the medical register (or equivalent UK professional register where the Principal Investigator is not a medical doctor) or is otherwise sanctioned by an applicable regulatory or other governmental authority, or is otherwise unavailable to continue as Principal Investigator. The Participating Organisation Trial Site shall use all reasonable endeavours to find a replacement acceptable to both the Sponsor and the Participating OrganisationTrial Site, subject to the Participating OrganisationTrial Site’s overriding obligations in relation to Non-Interventional Study Subjects Clinical Trial Participants and individual patient care. If no mutually acceptable replacement can be found the Sponsor may terminate this Agreement pursuant to Clause 14.3. The Participating Organisation Trial Site shall procure, and shall ensure that the Principal Investigator procures, the performance of the obligations of the Personnel as set out in this Agreement. The Principal Investigator and/or and / or Personnel shall attend any meetings regarding the Non-Interventional Study Clinical Trial as reasonably requested by the Sponsor (‘“Investigator Meetings’”). Such meetings to be conducted by the Sponsor to convey or exchange information with the Principal Investigator, all Sub-Investigators or other Personnel to support the effective conduct or close-out of the Non-Interventional StudyClinical Trial. The Participating Organisation Trial Site agrees that no additional compensation shall be due hereunder for Principal Investigator’s or any other Personnel’s respective participation in Investigator Meetings. The Sponsor shall reimburse or pay for reasonable pre-approved expenses for attendance at the Investigator Meetings upon receipt of documentation. It is further agreed that any such expenses will be paid at the rate of fair market value (as detailed in line with the applicable ABPI Code of Practice)and Practice) and subject to the documentation evidencing the expenses being in sufficient detail for the Sponsor’s financial reporting purposes, provided that the required detail does not impose an unreasonable administrative burden upon the Participating OrganisationTrial Site. Such expenses may be publicly reportable. The Participating Organisation Trial Site represents that it will support the Principal Investigator to make good faith diligent efforts to ensure the completion of all case report forms, where applicable, forms in a timely manner. The Trial Site through the Principal Investigator may appoint such other persons as the Principal Investigator may deem appropriate as Sub-Investigators or other Personnel to assist in the conduct of the Clinical Trial. All Personnel will be adequately qualified, timely appointed and an updated list will be maintained. Principal Investigator shall be responsible for leading such team of Personnel. The Trial Site and Principal Investigator are responsible for the services performed by the Personnel and undertake in particular to have the services executed by competent persons. In the event that the Trial Site and / or Principal Investigator use the services of others to conduct the Clinical Trial pursuant to this Agreement, the Trial Site and Principal Investigator shall be responsible for ensuring that all are appropriate, in compliance with the terms of this Agreement. The Trial Site shall be liable for any breach of this Agreement by the Principal Investigator and / or Personnel.

Principal Investigator and Personnel. The Participating Organisation Trial Site represents that it is entitled to procure, and the Participating Organisation Trial Site will procure the services of the Principal Investigator, any and all Sub-Investigators and other Personnel, to fulfil these functions and shall ensure the performance of the obligations of the Principal Investigator, any and all Sub-Investigators and other Personnel set out in Appendix 3 5 and elsewhere in this Agreement. Where the Participating Organisation Trial Site is not the Principal Investigator’s substantive employer it will notify the Principal Investigator’s substantive employer in a timely way of the Principal Investigator’s his/her proposed involvement in the Non-Interventional StudyClinical Investigation. Any financial or other arrangements relating to the Principal Investigator's involvement in the Non-Interventional Study Clinical Investigation will be agreed directly between the Participating Organisation Trial Site and the Principal Investigator’s substantive employer. The Participating Organisation Trial Site represents that the Principal Investigator holds the necessary registration and has the necessary expertise, time and resources to perform the Non-Interventional Study Clinical Investigation and will ensure that the Principal Investigator is made aware of and acknowledges the obligations applicable to the Principal Investigator set out in this Agreement, including but not limited to those set out in Appendix 35. The Participating Organisation Trial Site shall notify the Sponsor and CRO if the Principal Investigator ceases to be employed by or associated with the Participating OrganisationTrial Site, is erased from the medical register (or equivalent UK professional register where the Principal Investigator is not a medical doctor) or is otherwise sanctioned by an applicable regulatory or other governmental authority, or is otherwise unavailable to continue as Principal Investigator. The Participating Organisation Trial Site shall use all reasonable endeavours to find a replacement acceptable to both the Sponsor and the Participating Organisationall Parties, subject to the Participating OrganisationTrial Site’s overriding obligations in relation to Non-Interventional Study Clinical Investigation Subjects and individual patient care. If no mutually acceptable replacement can be found the Sponsor or CRO may terminate this Agreement pursuant to Clause 14.3. The Participating Organisation Trial Site shall procure, and shall ensure that the Principal Investigator procures, the performance of the obligations of the Personnel as set out in this Agreement. The Principal Investigator and/or Personnel shall attend any meetings regarding the Non-Interventional Study Clinical Investigation as reasonably requested by the Sponsor or CRO (‘“Investigator Meetings’”). Such meetings to be conducted by the Sponsor or CRO to convey or exchange information with the Principal Investigator, all Sub-Investigators or other Personnel to support the effective conduct or close-out of the Non-Interventional StudyClinical Investigation. The Participating Organisation Trial Site agrees that no additional compensation shall be due hereunder for Principal Investigator’s or any other Personnel’s respective participation in Investigator Meetings. The Sponsor or CRO shall reimburse or pay for reasonable pre-approved expenses for attendance at the Investigator Meetings upon receipt of documentation. It is further agreed that any such expenses will be paid at the rate of fair market value (as detailed in line with the applicable ABHI Code of Practice)and Ethical Business Practice) and subject to the documentation evidencing the expenses being in sufficient detail for the Sponsor’s financial reporting purposespurposes of the Party making payment, provided that the required detail does not impose an unreasonable administrative burden upon the Participating OrganisationTrial Site. Such expenses may be publicly reportable. The Participating Organisation Trial Site represents that it will support the Principal Investigator to make good faith diligent efforts to ensure the completion of all case report forms, where applicable, forms in a timely manner. The Trial Site through the Principal Investigator may appoint such other persons as the Principal Investigator may deem appropriate as Sub-Investigators or other Personnel to assist in the conduct of the Clinical Investigation. All Personnel will be adequately qualified, timely appointed and an updated list will be maintained. The Principal Investigator shall be responsible for leading such team of Personnel. The Trial Site and Principal Investigator are responsible for the services performed by the Personnel and undertake in particular to have the services executed by competent persons. In the event that the Trial Site and/or Principal Investigator use the services of others to conduct the Clinical Investigation pursuant to this Agreement, the Trial Site and Principal Investigator shall be responsible for ensuring that all are appropriate, in compliance with the terms of this Agreement. The Trial Site shall be liable for any breach of this Agreement by the Principal Investigator and/or Personnel.