Common use of Liabilities and Indemnities Clause in Contracts

Liabilities and Indemnities. In the event of any claim or proceeding in respect of personal injury made or brought against the Trial Site by a Clinical Investigation Participant, the Sponsor shall indemnify the Trial Site, its Agents and employees in accordance with the terms of the indemnity set out in Appendix 3 hereto. Nothing in this Clause 5 shall operate so as to restrict or exclude the liability of any Party in relation to death or personal injury caused by the negligence or wilful misconduct of that Party or its Agents or employees, or to restrict or exclude any other liability of any Party that cannot be so restricted or excluded in law. In no circumstances shall any Party be liable to another Party in contract, tort or delict (if the Trial Site is constituted in Scotland) (including negligence or breach of statutory duty) or otherwise howsoever arising or whatever the cause thereof, for any loss of profit, business, reputation, contracts, revenues or anticipated savings or for any special, indirect or consequential damage of any nature, which arises directly or indirectly from any default on the part of any other Party. The CRO expressly disclaims any liability in connection with Investigational Medical Device(s) caused by or allegedly caused by the use or misuse of the Investigational Medical Device(s) other than liability for death, personal injury or loss of or damage to property which liability is the result of negligence on the part of the CRO. Subject to Clauses 5.2 and 5.5 the Trial Site’s liability to the Sponsor and CRO arising out of or in connection with any breach of this Agreement or any act or omission of the Trial Site in connection with the performance of the Clinical Investigation shall in no event exceed the amount of fees payable by the Sponsor or CRO to the Trial Site under this Agreement. In the case of equipment loaned to the Trial Site for the purposes of the Clinical Investigation, the Trial Site’s liability for loss or damage to this equipment arising from its negligence shall exclude fair wear and tear and shall not exceed the value of the equipment. For clarity, the “fees payable” are the total sum of the amounts specified in Appendix 4 based on the full enrolment of Clinical Investigation Participants for the full period of the Clinical Investigation. In respect of any wilful and / or deliberate breach by the Trial Site, or any breach of Clauses 6, 8, 10 or 11 the Trial Site’s liability to the Sponsor and CRO arising out of or in connection with the breach shall not exceed two times the value of the Agreement. For clarity, the “value of the Agreement” is the total sum of the amounts specified in Appendix 4 based on the full enrolment of Clinical Investigation Participants for the full period of the Clinical Investigation. The Sponsor will take out appropriate insurance cover or will provide an indemnity satisfactory to the Trial Site in respect of its potential liability under Clause 5.1 above and such cover shall be for a minimum of [INSERT AMOUNT] as detailed in the certificate of insurance provided by the Sponsor or CRO to the Trial Site. The Trial Site will maintain its membership of the relevant NHS clinical negligence indemnity scheme(s) for the duration of the Clinical Investigation. The Sponsor shall produce to the Trial Site on request, copies of insurance certificates, together with evidence that the policies to which they refer remain in full force and effect, or other evidence concerning the indemnity. The Trial Site shall produce to the Sponsor or CRO on request evidence of its continued membership of the relevant NHS clinical negligence indemnity scheme(s). The terms of insurance, or of the relevant NHS clinical negligence indemnity scheme(s), or the amount of cover, shall not relieve any Party of any liabilities under this Agreement. Nothing in this Agreement will operate to limit or exclude any liability for fraud.

Liabilities and Indemnities. In the event of any claim or proceeding in respect of personal injury made or brought against the Trial Site by a Clinical Investigation ParticipantSubject, the Sponsor shall indemnify the Trial Site, its Agents and employees in accordance with the terms of the indemnity set out in Appendix 3 hereto. Nothing in this Clause 5 shall operate so as to restrict or exclude the liability of any Party in relation to death or personal injury caused by the negligence or wilful misconduct of that Party or its Agents or employees, or to restrict or exclude any other liability of any either Party that cannot be so restricted or excluded in law. In no circumstances shall any either Party be liable to another the other Party in contract, tort or delict (if the Trial Site is constituted in Scotland) (including negligence or breach of statutory duty) or otherwise howsoever arising or whatever the cause thereof, for any loss of profit, business, reputation, contracts, revenues or anticipated savings or for any special, indirect or consequential damage of any nature, which arises directly or indirectly from any default on the part of any other Party. The CRO expressly disclaims any liability in connection with Investigational Medical Device(s) caused by or allegedly caused by the use or misuse of the Investigational Medical Device(s) other than liability for death, personal injury or loss of or damage to property which liability is the result of negligence on the part of the CRO. Subject to Clauses 5.2 and 5.5 the Trial Site’s liability to the Sponsor and CRO arising out of or in connection with any breach of this Agreement or any act or omission of the Trial Site in connection with the performance of the Clinical Investigation shall in no event exceed the amount of fees payable by the Sponsor or CRO to the Trial Site under this Agreement. In the case of equipment loaned to the Trial Site for the purposes of the Clinical Investigation, the Trial Site’s liability for loss or damage to this equipment arising from its negligence shall exclude fair wear and tear and shall not exceed the value of the equipment. For clarity, the “fees payable” are the total sum of the amounts specified in Appendix 4 based on the full enrolment of Clinical Investigation Participants for the full period of the Clinical Investigation. In respect of any wilful and / or and/or deliberate breach by the Trial Site, or any breach of Clauses 6, 8, 10 or 11 the Trial Site’s liability to the Sponsor and CRO arising out of or in connection with the breach shall not exceed two times the value of the Agreement. For clarity, the “value of the Agreement” is the total sum of the amounts specified in Appendix 4 based on the full enrolment of Clinical Investigation Participants for the full period of the Clinical Investigation. The Sponsor will take out appropriate insurance cover or will provide an indemnity satisfactory to the Trial Site in respect of its potential liability under Clause 5.1 above and such cover shall be for a minimum of [INSERT AMOUNT] as detailed in the certificate of insurance provided by the Sponsor or CRO to the Trial Site. The Trial Site will maintain its membership of the relevant NHS clinical negligence indemnity scheme(s) for the duration of the Clinical Investigation. The Sponsor shall produce to the Trial Site on request, copies of insurance certificates, together with evidence that the policies to which they refer remain in full force and effect, or other evidence concerning the indemnity. The Trial Site shall produce to the Sponsor or CRO on request evidence of its continued membership of the relevant NHS clinical negligence indemnity scheme(s). The terms of insurance, or of the relevant NHS clinical negligence indemnity scheme(s), or the amount of cover, shall not relieve any either Party of any liabilities under this Agreement. Nothing in this Agreement will operate to limit or exclude any liability for fraud.

Liabilities and Indemnities. In the event of any claim or proceeding in respect of personal injury made or brought against the Trial Site by a Clinical Investigation Trial Participant, the Sponsor shall indemnify the Trial Site, its Agents and employees in accordance with the terms of the indemnity set out in Appendix 3 hereto. Nothing in this Clause 5 shall operate so as to restrict or exclude the liability of any Party in relation to death or personal injury caused by the negligence or wilful misconduct of that Party or its Agents or employees, or to restrict or exclude any other liability of any either Party that cannot be so restricted or excluded in law. In no circumstances shall any either Party be liable to another the other Party in contract, tort or delict (if the Trial Site is constituted in Scotland) (including negligence or breach of statutory duty) or otherwise howsoever arising or whatever the cause thereof, for any loss of profit, business, reputation, contracts, revenues or anticipated savings or for any special, indirect or consequential damage of any nature, which arises directly or indirectly from any default on the part of any other Party. The CRO expressly disclaims any liability in connection with Investigational Medical Device(s) caused by or allegedly caused by the use or misuse of the Investigational Medical Device(s) other than liability for death, personal injury or loss of or damage to property which liability is the result of negligence on the part of the CRO. Subject to Clauses 5.2 and 5.5 the Trial Site’s liability to the Sponsor and CRO arising out of or in connection with any breach of this Agreement or any act or omission of the Trial Site in connection with the performance of the Clinical Investigation Trial shall in no event exceed the amount of fees payable by the Sponsor or CRO to the Trial Site under this Agreement. In the case of equipment loaned to the Trial Site for the purposes of the Clinical InvestigationTrial, the Trial Site’s liability for loss or damage to this equipment arising from its negligence shall exclude fair wear and tear and shall not exceed the value of the equipment. For clarity, the “fees payable” are the total sum of the amounts specified in Appendix 4 based on the full enrolment of Clinical Investigation Trial Participants for the full period of the Clinical InvestigationTrial. In respect of any wilful and / or deliberate breach by the Trial Site, or any breach of Clauses 6, 8, 10 or 11 the Trial Site’s liability to the Sponsor and CRO arising out of or in connection with the breach shall not exceed two times the value of the Agreement. For clarity, the “value of the Agreement” is the total sum of the amounts specified in Appendix 4 based on the full enrolment of Clinical Investigation Trial Participants for the full period of the Clinical InvestigationTrial. The Sponsor will take out appropriate insurance cover or will provide an indemnity satisfactory to the Trial Site in respect of its potential liability under Clause 5.1 above and such cover shall be for a minimum of [INSERT AMOUNT] as detailed in the certificate of insurance provided by the Sponsor or CRO to the Trial Site. The Where the Trial Site is established in England, the Clinical Negligence Scheme for General Practice will maintain its membership of the relevant NHS provide cover for clinical negligence indemnity scheme(s) for in the duration conduct of the Clinical InvestigationTrial. For Trial Sites established in Northern Ireland, Scotland or Wales, the Trial Site represents that its Principal Investigator and Personnel shall have adequate insurance or indemnity arrangements in place to cover against clinical negligence in the conduct of the Clinical Trial, until the completion of the Clinical Trial. The Sponsor shall produce to the Trial Site on request, copies of insurance certificates, together with evidence that the policies to which they refer remain in full force and effect, or other evidence concerning the indemnity. The If the Trial Site is established in Northern Ireland, Scotland or Wales it shall produce to the Sponsor or CRO on request evidence of its continued membership of the relevant NHS clinical negligence indemnity scheme(s)appropriate insurance or indemnity. The terms of insurance, or of the relevant NHS clinical negligence indemnity scheme(s), or the amount of cover, shall not relieve any either Party of any liabilities under this Agreement. Nothing in this Agreement will operate to limit or exclude any liability for fraud.

Liabilities and Indemnities. In the event of any claim or proceeding in respect of personal injury made or brought against the Trial Site or Principal Investigator by a Clinical Investigation Participant, the Sponsor shall indemnify the Trial SiteSite and the Principal Investigator, its their Agents and employees in accordance with the terms of the indemnity set out in Appendix 3 hereto. Nothing in this Clause 5 shall operate so as to restrict or exclude the liability of any Party in relation to death or personal injury caused by the negligence or wilful misconduct of that Party or its Agents or employees, or to restrict or exclude any other liability of any Party that cannot be so restricted or excluded in law. In no circumstances shall any a Party be liable to another Party in contract, tort or delict (if the Trial Site is constituted in Scotland) (including negligence or breach of statutory duty) or otherwise howsoever arising or whatever the cause thereof, for any loss of profit, business, reputation, contracts, revenues or anticipated savings or for any special, indirect or consequential damage of any nature, which arises directly or indirectly from any default on the part of any other Party. The CRO expressly disclaims any liability in connection with Investigational Medical Device(s) caused by or allegedly caused by the use or misuse of the Investigational Medical Device(s) other than liability for death, personal injury or loss of or damage to property which liability is the result of negligence on the part of the CRO. Subject to Clauses 5.2 and 5.5 the Trial Site’s and Principal Investigator’s liability to the Sponsor and CRO arising out of or in connection with any breach of this Agreement or any act or omission of the Trial Site or Principal Investigator in connection with the performance of the Clinical Investigation Trial shall in no event exceed the amount of fees payable by the Sponsor or CRO to the Trial Site and Principal Investigator under this Agreement. In the case of equipment loaned to the Trial Site or Principal Investigator for the purposes of the Clinical InvestigationTrial, the Trial Site’s and Principal Investigator’s liability for loss or damage to this equipment arising from its negligence shall exclude fair wear and tear and shall not exceed the value of the equipment. For clarity, the “fees payable” are the total sum of the amounts specified in Appendix 4 based on the full enrolment of Clinical Investigation Trial Participants for the full period of the Clinical InvestigationTrial. In respect of any wilful and / or deliberate breach by the Trial SiteSite or Principal Investigator, or any breach of Clauses 6, 8, 10 or 11 the Trial Site’s and Principal Investigator’s liability to the Sponsor and CRO arising out of or in connection with the breach shall not exceed two times the value of the Agreement. For clarity, the “value of the Agreement” is the total sum of the amounts specified in Appendix 4 based on the full enrolment of Clinical Investigation Participants for the full period of the Clinical InvestigationTrial. The Sponsor will take out appropriate insurance cover or will provide an indemnity satisfactory to the Trial Site and Principal Investigator in respect of its potential liability under Clause 5.1 above and such cover shall be for a minimum of [INSERT AMOUNT] as detailed in the certificate of insurance provided by the Sponsor or CRO to the Trial SiteSite and Principal Investigator. The Where the Trial Site is established in England, the Clinical Negligence Scheme for General Practice will maintain its membership of the relevant NHS provide cover for clinical negligence indemnity scheme(s) for in the duration conduct of the Clinical InvestigationTrial. For Trial Sites established in Northern Ireland, Scotland or Wales, the Trial Site and Principal Investigator represent that the Principal Investigator and Personnel shall have adequate insurance or indemnity arrangements in place to cover against clinical negligence in the conduct of the Clinical Trial, until the completion of the Clinical Trial. The Sponsor shall produce to the Trial Site and Principal Investigator on request, copies of insurance certificates, together with evidence that the policies to which they refer remain in full force and effect, or other evidence concerning the indemnity. The If the Trial Site is established in Northern Ireland, Scotland or Wales it or the Principal Investigator shall produce to the Sponsor or CRO on request evidence of its continued membership of the relevant NHS clinical negligence indemnity scheme(s)appropriate insurance or indemnity. The terms of insurance, or of the relevant NHS clinical negligence indemnity scheme(s), or the amount of cover, shall not relieve any a Party of any liabilities under this Agreement. Nothing in this Agreement will operate to limit or exclude any liability for fraud. Data Protection The Parties agree: To comply with all Data Protection Laws and Guidance in Processing the Personal Data of actual and potential Participants. This Clause 6 is in addition to and does not replace, relieve or remove a Party’s obligations or rights under the Data Protection Laws and Guidance. When one Party is Processing Personal Data, as Controller, for which another Party is at that time a separate and independent Controller, to promptly and without undue delay, notify and inform that other Party in the event of any Personal Data Breach that relates to that Personal Data.

Liabilities and Indemnities. In the event of any claim or proceeding in respect of personal injury made or brought against the Trial Site by a Clinical Investigation Participant, the Sponsor shall indemnify the Trial Site, its Agents and employees in accordance with the terms of the indemnity set out in Appendix 3 hereto. Nothing in this Clause 5 shall operate so as to restrict or exclude the liability of any Party in relation to death or personal injury caused by the negligence or wilful misconduct of that Party or its Agents or employees, or to restrict or exclude any other liability of any Party that cannot be so restricted or excluded in law. In no circumstances shall any Party be liable to another Party in contract, tort or delict (if the Trial Site is constituted in Scotland) (including negligence or breach of statutory duty) or otherwise howsoever arising or whatever the cause thereof, for any loss of profit, business, reputation, contracts, revenues or anticipated savings or for any special, indirect or consequential damage of any nature, which arises directly or indirectly from any default on the part of any other Party. The CRO expressly disclaims any liability in connection with Investigational Medical Device(s) Drugs caused by or allegedly caused by the use or misuse of the Investigational Medical Device(s) Drugs other than liability for death, personal injury or loss of or damage to property which liability is the result of negligence on the part of the CRO. Subject to Clauses 5.2 and 5.5 the Trial Site’s liability to the Sponsor and CRO arising out of or in connection with any breach of this Agreement or any act or omission of the Trial Site in connection with the performance of the Clinical Investigation Trial shall in no event exceed the amount of fees payable by the Sponsor or CRO to the Trial Site under this Agreement. In the case of equipment loaned to the Trial Site for the purposes of the Clinical InvestigationTrial, the Trial Site’s liability for loss or damage to this equipment arising from its negligence shall exclude fair wear and tear and shall not exceed the value of the equipment. For clarity, the “fees payable” are the total sum of the amounts specified in Appendix 4 based on the full enrolment of Clinical Investigation Participants for the full period of the Clinical InvestigationTrial. In respect of any wilful and / or deliberate breach by the Trial Site, or any breach of Clauses 6, 8, 10 or 11 the Trial Site’s liability to the Sponsor and CRO arising out of or in connection with the breach shall not exceed two times the value of the Agreement. For clarity, the “value of the Agreement” is the total sum of the amounts specified in Appendix 4 based on the full enrolment of Clinical Investigation Participants for the full period of the Clinical InvestigationTrial. The Sponsor will take out appropriate insurance cover or will provide an indemnity satisfactory to the Trial Site in respect of its potential liability under Clause 5.1 above and such cover shall be for a minimum of [INSERT AMOUNT] as detailed in the certificate of insurance provided by the Sponsor or CRO to the Trial Site. The Trial Site will maintain its membership of the relevant NHS clinical negligence indemnity scheme(s) for the duration of the Clinical InvestigationTrial. The Sponsor shall produce to the Trial Site on request, copies of insurance certificates, together with evidence that the policies to which they refer remain in full force and effect, or other evidence concerning the indemnity. The Trial Site shall produce to the Sponsor or CRO on request evidence of its continued membership of the relevant NHS clinical negligence indemnity scheme(s). The terms of insurance, or of the relevant NHS clinical negligence indemnity scheme(s), or the amount of cover, shall not relieve any Party of any liabilities under this Agreement. Nothing in this Agreement will operate to limit or exclude any liability for fraud. Data Protection The Parties agree: To comply with all Data Protection Laws and Guidance in Processing the Personal Data of actual and potential Participants. This Clause 6 is in addition to and does not replace, relieve or remove a Party’s obligations or rights under the Data Protection Laws and Guidance. When a Party is Processing Personal Data, as Controller, for which another Party is at that time a separate and independent Controller, to promptly and without undue delay, notify and inform that other Party in the event of any Personal Data Breach that relates to that Personal Data.

Liabilities and Indemnities. In the event of any claim or proceeding in respect of personal injury made or brought against the Trial Site by a Clinical Investigation Participant, the Sponsor shall indemnify the Trial Site, its Agents and employees in accordance with the terms of the indemnity set out in Appendix 3 hereto. Nothing in this Clause 5 shall operate so as to restrict or exclude the liability of any Party in relation to death or personal injury caused by the negligence or wilful misconduct of that Party or its Agents or employees, or to restrict or exclude any other liability of any Party that cannot be so restricted or excluded in law. In no circumstances shall any Party be liable to another Party in contract, tort or delict (if the Trial Site is constituted in Scotland) (including negligence or breach of statutory duty) or otherwise howsoever arising or whatever the cause thereof, for any loss of profit, business, reputation, contracts, revenues or anticipated savings or for any special, indirect or consequential damage of any nature, which arises directly or indirectly from any default on the part of any other Party. The CRO expressly disclaims any liability in connection with Investigational Medical Device(s) Drugs caused by or allegedly caused by the use or misuse of the Investigational Medical Device(s) Drugs other than liability for death, personal injury or loss of or damage to property which liability is the result of negligence on the part of the CRO. Subject to Clauses 5.2 and 5.5 the Trial Site’s liability to the Sponsor and CRO arising out of or in connection with any breach of this Agreement or any act or omission of the Trial Site in connection with the performance of the Clinical Investigation Trial shall in no event exceed the amount of fees payable by the Sponsor or CRO to the Trial Site under this Agreement. In the case of equipment loaned to the Trial Site for the purposes of the Clinical InvestigationTrial, the Trial Site’s liability for loss or damage to this equipment arising from its negligence shall exclude fair wear and tear and shall not exceed the value of the equipment. For clarity, the “fees payable” are the total sum of the amounts specified in Appendix 4 based on the full enrolment of Clinical Investigation Participants for the full period of the Clinical InvestigationTrial. In respect of any wilful and / or deliberate breach by the Trial Site, or any breach of Clauses 6, 8, 10 or 11 the Trial Site’s liability to the Sponsor and CRO arising out of or in connection with the breach shall not exceed two times the value of the Agreement. For clarity, the “value of the Agreement” is the total sum of the amounts specified in Appendix 4 based on the full enrolment of Clinical Investigation Participants for the full period of the Clinical InvestigationTrial. The Sponsor will take out appropriate insurance cover or will provide an indemnity satisfactory to the Trial Site in respect of its potential liability under Clause 5.1 above and such cover shall be for a minimum of [INSERT AMOUNT] as detailed in the certificate of insurance provided by the Sponsor or CRO to the Trial Site. The Trial Site will maintain its membership of the relevant NHS clinical negligence indemnity scheme(s) for the duration of the Clinical InvestigationTrial. The Sponsor shall produce to the Trial Site on request, copies of insurance certificates, together with evidence that the policies to which they refer remain in full force and effect, or other evidence concerning the indemnity. The Trial Site shall produce to the Sponsor or CRO on request evidence of its continued membership of the relevant NHS clinical negligence indemnity scheme(s). The terms of insurance, or of the relevant NHS clinical negligence indemnity scheme(s), or the amount of cover, shall not relieve any Party of any liabilities under this Agreement. Nothing in this Agreement will operate to limit or exclude any liability for fraud.

Liabilities and Indemnities. In the event of any claim or proceeding in respect of personal injury made or brought against the Trial Site by a Clinical Investigation ParticipantSubject, the Sponsor shall indemnify the Trial Site, its Agents and employees in accordance with the terms of the indemnity set out in Appendix 3 hereto. Nothing in this Clause 5 shall operate so as to restrict or exclude the liability of any Party in relation to death or personal injury caused by the negligence or wilful misconduct of that Party or its Agents or employees, or to restrict or exclude any other liability of any Party that cannot be so restricted or excluded in law. In no circumstances shall any Party be liable to another Party in contract, tort or delict (if the Trial Site is constituted in Scotland) (including negligence or breach of statutory duty) or otherwise howsoever arising or whatever the cause thereof, for any loss of profit, business, reputation, contracts, revenues or anticipated savings or for any special, indirect or consequential damage of any nature, which arises directly or indirectly from any default on the part of any other Party. The CRO expressly disclaims any liability in connection with Investigational Medical Device(s) caused by or allegedly caused by the use or misuse of the Investigational Medical Device(s) other than liability for death, personal injury or loss of or damage to property which liability is the result of negligence on the part of the CRO. Subject to Clauses 5.2 and 5.5 the Trial Site’s liability to the Sponsor and CRO arising out of or in connection with any breach of this Agreement or any act or omission of the Trial Site in connection with the performance of the Clinical Investigation shall in no event exceed the amount of fees payable by the Sponsor or CRO to the Trial Site under this Agreement. In the case of equipment loaned to the Trial Site for the purposes of the Clinical Investigation, the Trial Site’s liability for loss or damage to this equipment arising from its negligence shall exclude fair wear and tear and shall not exceed the value of the equipment. For clarity, the “fees payable” are the total sum of the amounts specified in Appendix 4 based on the full enrolment of Clinical Investigation Participants for the full period of the Clinical Investigation. In respect of any wilful and / or and/or deliberate breach by the Trial Site, or any breach of Clauses 6, 8, 10 or 11 the Trial Site’s liability to the Sponsor and CRO arising out of or in connection with the breach shall not exceed two times the value of the Agreement. For clarity, the “value of the Agreement” is the total sum of the amounts specified in Appendix 4 based on the full enrolment of Clinical Investigation Participants for the full period of the Clinical Investigation. The Sponsor will take out appropriate insurance cover or will provide an indemnity satisfactory to the Trial Site in respect of its potential liability under Clause 5.1 above and such cover shall be for a minimum of [INSERT AMOUNT] as detailed in the certificate of insurance provided by the Sponsor or CRO to the Trial Site. The Trial Site will maintain its membership of the relevant NHS clinical negligence indemnity scheme(s) for the duration of the Clinical Investigation. The Sponsor shall produce to the Trial Site on request, copies of insurance certificates, together with evidence that the policies to which they refer remain in full force and effect, or other evidence concerning the indemnity. The Trial Site shall produce to the Sponsor or CRO on request evidence of its continued membership of the relevant NHS clinical negligence indemnity scheme(s). The terms of insurance, or of the relevant NHS clinical negligence indemnity scheme(s), or the amount of cover, shall not relieve any Party of any liabilities under this Agreement. Nothing in this Agreement will operate to limit or exclude any liability for fraud.

Liabilities and Indemnities. In the event of any claim or proceeding in respect of personal injury made or brought against the Trial Site or Principal Investigator by a Clinical Investigation Trial Participant, the Sponsor shall indemnify the Trial SiteSite and the Principal Investigator, its their Agents and employees in accordance with the terms of the indemnity set out in Appendix 3 hereto. Nothing in this Clause 5 shall operate so as to restrict or exclude the liability of any Party in relation to death or personal injury caused by the negligence or wilful misconduct of that Party or its Agents or employees, or to restrict or exclude any other liability of any Party that cannot be so restricted or excluded in law. In no circumstances shall any a Party be liable to another Party in contract, tort or delict (if the Trial Site is constituted in Scotland) (including negligence or breach of statutory duty) or otherwise howsoever arising or whatever the cause thereof, for any loss of profit, business, reputation, contracts, revenues or anticipated savings or for any special, indirect or consequential damage of any nature, which arises directly or indirectly from any default on the part of any other Party. The CRO expressly disclaims any liability in connection with Investigational Medical Device(s) caused by or allegedly caused by the use or misuse of the Investigational Medical Device(s) other than liability for death, personal injury or loss of or damage to property which liability is the result of negligence on the part of the CRO. Subject to Clauses 5.2 and 5.5 the Trial Site’s and Principal Investigator’s liability to the Sponsor and CRO arising out of or in connection with any breach of this Agreement or any act or omission of the Trial Site or Principal Investigator in connection with the performance of the Clinical Investigation Trial shall in no event exceed the amount of fees payable by the Sponsor or CRO to the Trial Site and Principal Investigator under this Agreement. In the case of equipment loaned to the Trial Site or Principal Investigator for the purposes of the Clinical InvestigationTrial, the Trial Site’s and Principal Investigator’s liability for loss or damage to this equipment arising from its negligence shall exclude fair wear and tear and shall not exceed the value of the equipment. For clarity, the “fees payable” are the total sum of the amounts specified in Appendix 4 based on the full enrolment of Clinical Investigation Trial Participants for the full period of the Clinical InvestigationTrial. In respect of any wilful and / or deliberate breach by the Trial SiteSite or Principal Investigator, or any breach of Clauses 6, 8, 10 or 11 the Trial Site’s and Principal Investigator’s liability to the Sponsor and CRO arising out of or in connection with the breach shall not exceed two times the value of the Agreement. For clarity, the “value of the Agreement” is the total sum of the amounts specified in Appendix 4 based on the full enrolment of Clinical Investigation Trial Participants for the full period of the Clinical InvestigationTrial. The Sponsor will take out appropriate insurance cover or will provide an indemnity satisfactory to the Trial Site and Principal Investigator in respect of its potential liability under Clause 5.1 above and such cover shall be for a minimum of [INSERT AMOUNT] as detailed in the certificate of insurance provided by the Sponsor or CRO to the Trial SiteSite and Principal Investigator. The Trial Site Where the Participating Organisation is established in England, the Clinical Negligence Scheme for General Practice will maintain its membership of the relevant NHS provide cover for clinical negligence indemnity scheme(s) for in the duration conduct of the Clinical InvestigationTrial. For Trial Sites established in Northern Ireland, Scotland or Wales, the Trial Site and Principal Investigator represent that the Principal Investigator and Personnel shall have adequate insurance or indemnity arrangements in place to cover against clinical negligence in the conduct of the Clinical Trial, until the completion of the Clinical Trial. The Sponsor shall produce to the Trial Site and Principal Investigator on request, copies of insurance certificates, together with evidence that the policies to which they refer remain in full force and effect, or other evidence concerning the indemnity. The If the Trial Site is established in Northern Ireland, Scotland or Wales it or the Principal Investigator shall produce to the Sponsor or CRO on request evidence of its continued membership of the relevant NHS clinical negligence indemnity scheme(s)appropriate insurance or indemnity. The terms of insurance, or of the relevant NHS clinical negligence indemnity scheme(s), or the amount of cover, shall not relieve any a Party of any liabilities under this Agreement. Nothing in this Agreement will operate to limit or exclude any liability for fraud.

Liabilities and Indemnities. In the event of any claim or proceeding in respect of personal injury made or brought against the Trial Site Participating Organisation by a Clinical Investigation ParticipantTrial Subject, the Sponsor shall indemnify the Trial SiteParticipating Organisation, its Agents and employees in accordance with the terms of the indemnity set out in Appendix 3 heretoState Claims Agency’s Clinical Trial Indemnity. Nothing in this Clause 5 shall operate so as to restrict or exclude the liability of any Party in relation to death or personal injury caused by the negligence or wilful misconduct of that Party or its Agents or employees, or to restrict or exclude any other liability of any either Party that cannot be so restricted or excluded in law. In no circumstances shall any either Party be liable to another the other Party in contract, contract or tort or delict (if the Trial Site is constituted in Scotland) (including negligence or breach of statutory duty) or otherwise howsoever arising or whatever the cause thereof, for any loss of profit, business, reputation, contracts, revenues or anticipated savings or for any special, indirect or consequential damage of any nature, which arises directly or indirectly from any default on the part of any other Party. The CRO expressly disclaims any liability in connection with Investigational Medical Device(s) caused by or allegedly caused by the use or misuse of the Investigational Medical Device(s) other than liability for death, personal injury or loss of or damage to property which liability is the result of negligence on the part of the CRO. Subject to Clauses 5.2 and 5.5 the Trial SiteParticipating Organisation’s liability to the Sponsor and CRO arising out of or in connection with any breach of this Agreement or any act or omission of the Trial Site Participating Organisation in connection with the performance of the Clinical Investigation Trial shall in no event exceed the amount of fees payable by the Sponsor or CRO to the Trial Site Participating Organisation under this Agreement. In the case of equipment loaned to the Trial Site Participating Organisation for the purposes of the Clinical InvestigationTrial, the Trial SiteParticipating Organisation’s liability for loss or damage to this equipment arising from its negligence shall exclude fair wear and tear and shall not exceed the value of the equipment. For clarity, the “fees payable” are the total sum of the amounts specified in Appendix 4 based on the full enrolment of Clinical Investigation Participants for the full period of the Clinical Investigation. In respect of any wilful and / or and/or deliberate breach by the Trial SiteParticipating Organisation, or any breach of Clauses 6, 8, 10 or 11 the Trial SiteParticipating Organisation’s liability to the Sponsor and CRO arising out of or in connection with the breach shall not exceed two times the value of the Agreement. For clarity, the “value of the Agreement” is the total sum of the amounts specified in Appendix 4 based on the full enrolment of Clinical Investigation Participants for the full period of the Clinical Investigation. The Sponsor will take out appropriate insurance cover or will provide an indemnity satisfactory to the Trial Site Participating Organisation in respect of its potential liability under Clause 5.1 above and such cover shall be for a minimum of [INSERT AMOUNT] six million five hundred thousand Euros (€6,500,000) as detailed in the certificate of insurance provided by the Sponsor or CRO to the Trial SiteParticipating Organisation. The Trial Site Participating Organisation will maintain its membership of the relevant NHS clinical negligence indemnity scheme(sState Claims Agency’s Clinical Indemnity Scheme (“CIS”) (covering personal injury from medical malpractice or negligence), and the General Indemnity Scheme (“GIS”) (covering employers and public liability)) for the duration of the Clinical InvestigationTrial. The Sponsor shall produce to the Trial Site Participating Organisation on request, copies of insurance certificates, together with evidence that the policies to which they refer remain in full force and effect, or other evidence concerning the indemnity. The Trial Site Participating Organisation shall produce to the Sponsor or CRO on request evidence of its continued membership of the relevant NHS clinical negligence indemnity scheme(s)State Claims Agency’s CIS and/or GIS. The terms of insurance, or of the relevant NHS clinical State Claims Agency’s negligence indemnity scheme(s), or the amount of cover, shall not relieve any either Party of any liabilities under this Agreement. Nothing in this Agreement will operate to limit or exclude any liability for fraud.

Liabilities and Indemnities. In the event of any claim or proceeding in respect of personal injury made or brought against the Trial Site by a Clinical Investigation ParticipantTrial Subject, the Sponsor shall indemnify the Trial Site, its Agents and employees in accordance with the terms of the indemnity set out in Appendix 3 hereto. Nothing in this Clause 5 shall operate so as to restrict or exclude the liability of any Party in relation to death or personal injury caused by the negligence or wilful misconduct of that Party or its Agents or employees, or to restrict or exclude any other liability of any Party that cannot be so restricted or excluded in law. In no circumstances shall any Party be liable to another Party in contract, tort or delict (if the Trial Site is constituted in Scotland) (including negligence or breach of statutory duty) or otherwise howsoever arising or whatever the cause thereof, for any loss of profit, business, reputation, contracts, revenues or anticipated savings or for any special, indirect or consequential damage of any nature, which arises directly or indirectly from any default on the part of any other Party. The CRO expressly disclaims any liability in connection with Investigational Medical Device(s) Drugs caused by or allegedly caused by the use or misuse of the Investigational Medical Device(s) Drugs other than liability for death, personal injury or loss of or damage to property which liability is the result of negligence on the part of the CRO. Subject to Clauses 5.2 and 5.5 the Trial Site’s liability to the Sponsor and CRO arising out of or in connection with any breach of this Agreement or any act or omission of the Trial Site in connection with the performance of the Clinical Investigation Trial shall in no event exceed the amount of fees payable by the Sponsor or CRO to the Trial Site under this Agreement. In the case of equipment loaned to the Trial Site for the purposes of the Clinical InvestigationTrial, the Trial Site’s liability for loss or damage to this equipment arising from its negligence shall exclude fair wear and tear and shall not exceed the value of the equipment. For clarity, the “fees payable” are the total sum of the amounts specified in Appendix 4 based on the full enrolment of Clinical Investigation Participants for the full period of the Clinical Investigation. In respect of any wilful and / or and/or deliberate breach by the Trial Site, or any breach of Clauses 6, 8, 10 or 11 the Trial Site’s liability to the Sponsor and CRO arising out of or in connection with the breach shall not exceed two times the value of the Agreement. For clarity, the “value of the Agreement” is the total sum of the amounts specified in Appendix 4 based on the full enrolment of Clinical Investigation Participants for the full period of the Clinical Investigation. The Sponsor will take out appropriate insurance cover or will provide an indemnity satisfactory to the Trial Site in respect of its potential liability under Clause 5.1 above and such cover shall be for a minimum of [INSERT AMOUNT] as detailed in the certificate of insurance provided by the Sponsor or CRO to the Trial Site. The Trial Site will maintain its membership of the relevant NHS clinical negligence indemnity scheme(s) for the duration of the Clinical InvestigationTrial. The Sponsor shall produce to the Trial Site on request, copies of insurance certificates, together with evidence that the policies to which they refer remain in full force and effect, or other evidence concerning the indemnity. The Trial Site shall produce to the Sponsor or CRO on request evidence of its continued membership of the relevant NHS clinical negligence indemnity scheme(s). The terms of insurance, or of the relevant NHS clinical negligence indemnity scheme(s), or the amount of cover, shall not relieve any Party of any liabilities under this Agreement. Nothing in this Agreement will operate to limit or exclude any liability for fraud.

Liabilities and Indemnities. In the event of any claim or proceeding in respect of personal injury made or brought against the Trial Site Participating Organisation by a Clinical Investigation ParticipantTrial Subject, the Sponsor shall indemnify the Trial SiteParticipating Organisation, its Agents and employees in accordance with the terms of the indemnity set out in Appendix 3 heretoState Claims Agency’s Clinical Trial Indemnity. Nothing in this Clause 5 shall operate so as to restrict or exclude the liability of any Party in relation to death or personal injury caused by the negligence or wilful misconduct of that Party or its Agents or employees, or to restrict or exclude any other liability of any Party that cannot be so restricted or excluded in law. In no circumstances shall any Party be liable to another Party in contract, contract or tort or delict (if the Trial Site is constituted in Scotland) (including negligence or breach of statutory duty) or otherwise howsoever arising or whatever the cause thereof, for any loss of profit, business, reputation, contracts, revenues or anticipated savings or for any special, indirect or consequential damage of any nature, which arises directly or indirectly from any default on the part of any other Party. The CRO expressly disclaims any liability in connection with Investigational Medical Device(s) Drugs caused by or allegedly caused by the use or misuse of the Investigational Medical Device(s) Drugs other than liability for death, personal injury or loss of or damage to property which liability is the result of negligence on the part of the CRO. Subject to Clauses 5.2 and 5.5 the Trial SiteParticipating Organisation’s liability to the Sponsor and CRO arising out of or in connection with any breach of this Agreement or any act or omission of the Trial Site Participating Organisation in connection with the performance of the Clinical Investigation Trial shall in no event exceed the amount of fees payable by the Sponsor or CRO to the Trial Site Participating Organisation under this Agreement. In the case of equipment loaned to the Trial Site Participating Organisation for the purposes of the Clinical InvestigationTrial, the Trial SiteParticipating Organisation’s liability for loss or damage to this equipment arising from its negligence shall exclude fair wear and tear and shall not exceed the value of the equipment. For clarity, the “fees payable” are the total sum of the amounts specified in Appendix 4 based on the full enrolment of Clinical Investigation Participants for the full period of the Clinical Investigation. In respect of any wilful and / or and/or deliberate breach by the Trial SiteParticipating Organisation, or any breach of Clauses 6, 8, 10 or 11 the Trial SiteParticipating Organisation’s liability to the Sponsor and CRO arising out of or in connection with the breach shall not exceed two times the value of the Agreement. For clarity, the “value of the Agreement” is the total sum of the amounts specified in Appendix 4 based on the full enrolment of Clinical Investigation Participants for the full period of the Clinical Investigation. The Sponsor will take out appropriate insurance cover or will provide an indemnity satisfactory to the Trial Site Participating Organisation in respect of its potential liability under Clause 5.1 above and such cover shall be for a minimum of [INSERT AMOUNTInsert amount in figures and words] Euro (€XXXXXXX) as detailed in the certificate of insurance provided by the Sponsor or CRO to the Trial SiteParticipating Organisation. The Trial Site Participating Organisation will maintain its membership of the relevant NHS clinical negligence indemnity scheme(sState Claims Agency’s Clinical Indemnity Scheme (“CIS”) (covering personal injury from medical malpractice or negligence), and the General Indemnity Scheme (“GIS”) (covering employers and public liability)) for the duration of the Clinical InvestigationTrial. The Sponsor shall produce to the Trial Site Participating Organisation on request, copies of insurance certificates, together with evidence that the policies to which they refer remain in full force and effect, or other evidence concerning the indemnity. The Trial Site Participating Organisation shall produce to the Sponsor or CRO on request evidence of its continued membership of the relevant NHS clinical negligence indemnity scheme(s)State Claims Agency’s CIS and/or GIS. The terms of insurance, or of the relevant NHS clinical State Claims Agency’s negligence indemnity scheme(s), or the amount of cover, shall not relieve any Party of any liabilities under this Agreement. Nothing in this Agreement will operate to limit or exclude any liability for fraud.

Liabilities and Indemnities. In the event of any claim or proceeding in respect of personal injury made or brought against the Trial Site by a Clinical Investigation Participant, the Sponsor shall indemnify the Trial Site, its Agents and employees in accordance with the terms of the indemnity set out in Appendix 3 hereto. Nothing in this Clause 5 shall operate so as to restrict or exclude the liability of any Party in relation to death or personal injury caused by the negligence or wilful misconduct of that Party or its Agents or employees, or to restrict or exclude any other liability of any either Party that cannot be so restricted or excluded in law. In no circumstances shall any either Party be liable to another the other Party in contract, tort or delict (if the Trial Site is constituted in Scotland) (including negligence or breach of statutory duty) or otherwise howsoever arising or whatever the cause thereof, for any loss of profit, business, reputation, contracts, revenues or anticipated savings or for any special, indirect or consequential damage of any nature, which arises directly or indirectly from any default on the part of any other Party. The CRO expressly disclaims any liability in connection with Investigational Medical Device(s) caused by or allegedly caused by the use or misuse of the Investigational Medical Device(s) other than liability for death, personal injury or loss of or damage to property which liability is the result of negligence on the part of the CRO. Subject to Clauses 5.2 and 5.5 the Trial Site’s liability to the Sponsor and CRO arising out of or in connection with any breach of this Agreement or any act or omission of the Trial Site in connection with the performance of the Clinical Investigation shall in no event exceed the amount of fees payable by the Sponsor or CRO to the Trial Site under this Agreement. In the case of equipment loaned to the Trial Site for the purposes of the Clinical Investigation, the Trial Site’s liability for loss or damage to this equipment arising from its negligence shall exclude fair wear and tear and shall not exceed the value of the equipment. For clarity, the “fees payable” are the total sum of the amounts specified in Appendix 4 based on the full enrolment of Clinical Investigation Participants for the full period of the Clinical Investigation. In respect of any wilful and / or deliberate breach by the Trial Site, or any breach of Clauses 6, 8, 10 or 11 the Trial Site’s liability to the Sponsor and CRO arising out of or in connection with the breach shall not exceed two times the value of the Agreement. For clarity, the “value of the Agreement” is the total sum of the amounts specified in Appendix 4 based on the full enrolment of Clinical Investigation Participants for the full period of the Clinical Investigation. The Sponsor will take out appropriate insurance cover or will provide an indemnity satisfactory to the Trial Site in respect of its potential liability under Clause 5.1 above and such cover shall be for a minimum of [INSERT AMOUNT] as detailed in the certificate of insurance provided by the Sponsor or CRO to the Trial Site. The Trial Site will maintain its membership of the relevant NHS clinical negligence indemnity scheme(s) for the duration of the Clinical Investigation. The Sponsor shall produce to the Trial Site on request, copies of insurance certificates, together with evidence that the policies to which they refer remain in full force and effect, or other evidence concerning the indemnity. The Trial Site shall produce to the Sponsor or CRO on request evidence of its continued membership of the relevant NHS clinical negligence indemnity scheme(s). The terms of insurance, or of the relevant NHS clinical negligence indemnity scheme(s), or the amount of cover, shall not relieve any either Party of any liabilities under this Agreement. Nothing in this Agreement will operate to limit or exclude any liability for fraud.

Liabilities and Indemnities. In the event of any claim or proceeding in respect of personal injury made or brought against the Trial Site by a Clinical Investigation Participant, the Sponsor shall indemnify the Trial Site, its Agents and employees in accordance with the terms of the indemnity set out in Appendix 3 hereto. Nothing in this Clause 5 shall operate so as to restrict or exclude the liability of any Party in relation to death or personal injury caused by the negligence or wilful misconduct of that Party or its Agents or employees, or to restrict or exclude any other liability of any either Party that cannot be so restricted or excluded in law. In no circumstances shall any either Party be liable to another the other Party in contract, tort or delict (if the Trial Site is constituted in Scotland) (including negligence or breach of statutory duty) or otherwise howsoever arising or whatever the cause thereof, for any loss of profit, business, reputation, contracts, revenues or anticipated savings or for any special, indirect or consequential damage of any nature, which arises directly or indirectly from any default on the part of any other Party. The CRO expressly disclaims any liability in connection with Investigational Medical Device(s) caused by or allegedly caused by the use or misuse of the Investigational Medical Device(s) other than liability for death, personal injury or loss of or damage to property which liability is the result of negligence on the part of the CRO. Subject to Clauses 5.2 and 5.5 the Trial Site’s liability to the Sponsor and CRO arising out of or in connection with any breach of this Agreement or any act or omission of the Trial Site in connection with the performance of the Clinical Investigation shall in no event exceed the amount of fees payable by the Sponsor or CRO to the Trial Site under this Agreement. In the case of equipment loaned to the Trial Site for the purposes of the Clinical Investigation, the Trial Site’s liability for loss or damage to this equipment arising from its negligence shall exclude fair wear and tear and shall not exceed the value of the equipment. For clarity, the “fees payable” are the total sum of the amounts specified in Appendix 4 based on the full enrolment of Clinical Investigation Participants for the full period of the Clinical Investigation. In respect of any wilful and / or deliberate breach by the Trial Site, or any breach of Clauses 6, 8, 10 or 11 the Trial Site’s liability to the Sponsor and CRO arising out of or in connection with the breach shall not exceed two times the value of the Agreement. For clarity, the “value of the Agreement” is the total sum of the amounts specified in Appendix 4 based on the full enrolment of Clinical Investigation Participants for the full period of the Clinical Investigation. The Sponsor will take out appropriate insurance cover or will provide an indemnity satisfactory to the Trial Site in respect of its potential liability under Clause 5.1 above and such cover shall be for a minimum of [INSERT AMOUNT] as detailed in the certificate of insurance provided by the Sponsor or CRO to the Trial Site. The Trial Site will maintain its membership of the relevant NHS clinical negligence indemnity scheme(s) for the duration of the Clinical Investigation. The Sponsor shall produce to the Trial Site on request, copies of insurance certificates, together with evidence that the policies to which they refer remain in full force and effect, or other evidence concerning the indemnity. The Trial Site shall produce to the Sponsor or CRO on request evidence of its continued membership of the relevant NHS clinical negligence indemnity scheme(s). The terms of insurance, or of the relevant NHS clinical negligence indemnity scheme(s), or the amount of cover, shall not relieve any either Party of any liabilities under this Agreement. Nothing in this Agreement will operate to limit or exclude any liability for fraud. Data Protection The Parties agree: To comply with all Data Protection Laws and Guidance in Processing the Personal Data of actual and potential Participants. This Clause 6 is in addition to and does not replace, relieve or remove a Party’s obligations or rights under the Data Protection Laws and Guidance. When one Party is Processing Personal Data, as Controller, for which the other Party is at that time a separate and independent Controller, to promptly and without undue delay, notify and inform that other Party in the event of any Personal Data Breach that relates to that Personal Data.