Common use of Clause 5: Liabilities and Indemnities Clause in Contracts

Clause 5: Liabilities and Indemnities. It is essential that Sponsors and Participating Organisations (and CROs, where relevant) indemnify each other for any liabilities other than those covered under the ABPI Indemnity Agreement in case participation in a clinical trial results in damage to either party’s property and facilities. Hospitals’ non-clinical liabilities in relation to research are not usually covered by existing NHS litigation schemes and it is unlikely that their management would authorise the taking on of unquantified and potentially unlimited liabilities, such as might arise from an Intellectual Property Rights claim. The liabilities of Participating Organisations to Sponsors (and CROs, where applicable) have been capped at two different levels depending on the nature of the breach. The first cap, covering (a) wilful and/or deliberate breaches of the agreement and (b) any breach related to Clauses 6, (Data Protection), 7 (Freedom of Information) 8 (Confidential Information), 10 (Publications) and 11 (Intellectual Property), provides for the Participating Organisation’s liability to be limited to a maximum of twice the value of the agreement. The agreement value is the total payment due to be made by the Sponsor (or CRO, as applicable) to the Participating Organisation, if the target number of patients is recruited. The second cap covers all other breaches of the agreement by the Participating Organisation, and limits the Participating Organisation’s liability to the maximum value of the contract. While for a number of types of possible breaches these provisions might not fully compensate the Sponsor (or CRO) for their loss, it is considered that the risk of paying compensation on this basis provides an additional incentive for Participating Organisations to take every reasonable precaution to prevent a breach of the agreement. These precautions could include (i) having in place robust research governance arrangements; (ii) instituting training programmes for researchers undertaking commercial trials; (iii) emphasising to staff the importance of protecting the integrity of Sponsors’ (and CROs) confidential information; and taking disciplinary action in the event of a wilful or reckless breach of the provisions of clinical trial agreements. Under the Medicines for Human Use (Clinical Trials) Regulations 2004, Sponsors are not required to take out clinical trials insurance, but Participating Organisations will wish to be assured either that sufficient insurance cover has been purchased, or that the Sponsor has provided an indemnity covering potential liabilities to Clinical Trial Subjects participating in the relevant trial. Research ethics committees that provide an opinion on the trial proposal, may therefore take a view, in relation to the risks posed by a specific trial, as to the indemnity and/or the adequacy of the Sponsor’s clinical trials insurance.

Clause 5: Liabilities and Indemnities. It is essential that Sponsors and Participating Organisations (and CROs, where relevant) indemnify each other for any liabilities other than those covered under the ABPI Indemnity Agreement Agreement, in case participation in a clinical trial results in damage to either a party’s property and facilities. Hospitals’ non-clinical liabilities in relation to research are not usually covered by existing NHS litigation schemes and it is unlikely that their management would authorise the taking on of unquantified and potentially unlimited liabilities, such as might arise from an Intellectual Property Rights intellectual property rights claim. The liabilities of Participating Organisations to Sponsors (and CROs, where applicable) have been capped at two different levels depending on the nature of the breach. The first cap, covering (a) wilful and/or deliberate breaches of the agreement and (b) any breach related to Clauses 6, (Data Protection), 7 (Freedom of Information) ), 8 (Confidential Information), 10 (Publications) and 11 (Intellectual Property), provides for the Participating Organisation’s liability to be limited to a maximum of twice the value of the agreement. The agreement value is the total payment due to be made by the Sponsor (or CRO, as applicable) to the Participating Organisation, if the target number of patients is recruited. The second cap covers all other breaches of the agreement by the Participating Organisation, Organisation and limits the Participating Organisation’s liability to the maximum value of the contract. While for a number of types of possible breaches these provisions might not fully compensate the Sponsor (or CRO) for their loss, it is considered that the risk of paying compensation on this basis provides an additional incentive for Participating Organisations to take every reasonable precaution to prevent a breach of the agreement. These precautions could include include: (i) having in place robust research governance arrangements; (ii) instituting training programmes for researchers undertaking commercial trials; (iii) emphasising to staff the importance of protecting the integrity of Sponsors’ (and CROs) confidential information; and taking disciplinary action in the event of a wilful or reckless breach of the provisions of clinical trial agreements. Under the The Medicines for Human Use (Clinical Trials) Regulations 2004, Sponsors are not required to take out clinical trials insurance, but Participating Organisations will wish to be assured either that sufficient insurance cover has been purchased, or that the Sponsor has provided an indemnity covering potential liabilities to Clinical Trial Subjects clinical trial subjects participating in the relevant clinical trial. Research ethics committees that provide an opinion on the trial proposal, may therefore take a view, in relation to the risks posed by a specific clinical trial, as to the indemnity and/or the adequacy of the Sponsor’s clinical trials insurance.

Clause 5: Liabilities and Indemnities. It is essential that Sponsors and Participating Organisations (and CROs, where relevant) the respective Parties indemnify each other for any liabilities other than those covered under the ABPI Indemnity Agreement Agreement, in case participation in a clinical trial results in damage to either partya Party’s property and facilities. HospitalsNHS primary care independent contractors’ non-clinical liabilities in relation to research are not usually covered by existing NHS litigation schemes and it is unlikely that their management would authorise the taking on of unquantified and potentially unlimited liabilities, such as might arise from an Intellectual Property Rights intellectual property rights claim. The liabilities of Participating Organisations Trial Sites (and Principal Investigators, where tri-partite) to Sponsors (and CROs, where applicable) have been capped at two different levels depending on the nature of the breach. The first cap, covering (a) wilful and/or and / or deliberate breaches of the agreement Agreement and (b) any breach related to Clauses 6, 6 (Data Protection), 7 (Freedom of Information) ), 8 (Confidential Information), 10 (Publications) and / or 11 (Intellectual Property), provides for the Participating OrganisationTrial Site’s (and Principal Investigator’s, where tripartite) liability to be limited to a maximum of twice the value of the agreementAgreement. The agreement Agreement value is the total payment due to be made by the Sponsor (or CRO, as applicable) to the Participating OrganisationTrial Site, if the target number of patients is recruited. The second cap covers all other breaches of the agreement Agreement by the Participating OrganisationTrial Site (and / or Principal Investigator, if tripartite) and limits the Participating OrganisationTrial Site’s / Principal Investigator’s liability to the maximum value of the contractAgreement. While for a number of types of possible breaches these provisions might not fully compensate the Sponsor (or CRO) for their loss, it is considered that the risk of paying compensation on this basis provides an additional incentive for Participating Organisations Trial Sites / Principal Investigators to take every reasonable precaution to prevent a breach of the agreementAgreement. These precautions could include include: (i) having in place robust research governance arrangements; (ii) instituting training programmes for researchers undertaking commercial clinical trials; (iii) emphasising to staff the importance of protecting the integrity of the Sponsors’ (and CROs) confidential information; and taking disciplinary action in the event of a wilful or reckless breach of the provisions of clinical trial agreements. Under the Medicines for Human Use (Clinical Trials) Regulations 2004, Sponsors are not required to take out clinical trials insurance, but Participating Organisations Trial Sites / Principal Investigators will wish to be assured either that sufficient insurance cover has been purchased, or that the Sponsor has provided an indemnity covering potential liabilities to Clinical Trial Subjects Participants participating in the relevant clinical trial. Research ethics committees that provide an opinion on the trial proposalclinical trial, may therefore take a view, in relation to the risks posed by a specific clinical trial, as to the indemnity and/or and / or the adequacy of the Sponsor’s clinical trials insurance.

Clause 5: Liabilities and Indemnities. It is essential that Sponsors and Participating Organisations (and CROs, where relevant) the respective Parties indemnify each other for any liabilities other than those covered under the ABPI Indemnity Agreement Agreement, in case participation in a clinical trial results in damage to either partya Party’s property and facilities. HospitalsIndependent contractor general practices’ non-clinical liabilities in relation to research are not usually covered by existing NHS litigation schemes and it is unlikely that their management would authorise the taking on of unquantified and potentially unlimited liabilities, such as might arise from an Intellectual Property Rights intellectual property rights claim. The liabilities of Participating Organisations to Sponsors (and CROsPrincipal Investigators, where applicabletri- partite) have been capped at two different levels depending on the nature of the breach. The first cap, covering (a) wilful and/or deliberate breaches of the agreement Agreement and (b) any breach related to Clauses 6, (Data Protection), 7 (Freedom of Information) ), 8 (Confidential Information), 10 (Publications) and and/or 11 (Intellectual Property), provides for the Participating Organisation’s (and Principal Investigator’s, where tripartite) liability to be limited to a maximum of twice the value of the agreementAgreement. The agreement Agreement value is the total payment due to be made by the Sponsor (or CRO, as applicable) to the Participating Organisation, if the target number of patients is recruited. The second cap covers all other breaches of the agreement Agreement by the Participating OrganisationOrganisation (and/or Principal Investigator, if tripartite) and limits the Participating OrganisationOrganisation’s/Principal Investigator’s liability to the maximum value of the contractAgreement. While for a number of types of possible breaches these provisions might not fully compensate the Sponsor (or CRO) for their loss, it is considered that the risk of paying compensation on this basis provides an additional incentive for Participating Organisations Organisations/Principal Investigators to take every reasonable precaution to prevent a breach of the agreementAgreement. These precautions could include include: (i) having in place robust research governance arrangements; (ii) instituting training programmes for researchers undertaking commercial clinical trials; (iii) emphasising to staff the importance of protecting the integrity of the Sponsors’ (and CROs) confidential information; and taking disciplinary action in the event of a wilful or reckless breach of the provisions of clinical trial agreements. Under the Medicines for Human Use (Clinical Trials) Regulations 2004, Sponsors are not required to take out clinical trials insurance, but Participating Organisations Organisations/ Principal Investigators will wish to be assured either that sufficient insurance cover has been purchased, or that the Sponsor has provided an indemnity covering potential liabilities to Clinical Trial Subjects participating in the relevant clinical trial. Research ethics committees that provide an opinion on the trial proposalclinical trial, may therefore take a view, in relation to the risks posed by a specific clinical trial, as to the indemnity and/or the adequacy of the Sponsor’s clinical trials insurance.