Common use of Regulatory and Ethical Considerations Clause in Contracts

Regulatory and Ethical Considerations. This study will be conducted in accordance with the protocol and with the following: − Consensus ethical principles derived from international guidelines including the Declaration of Helsinki and Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines − Applicable ICH Good Clinical Practice (GCP) Guidelines − Applicable laws and regulations • The protocol, protocol amendments, ICF, IB, and other relevant documents (eg, advertisements) must be submitted to an IRB/IEC by the Investigator and reviewed and approved by the IRB/IEC before the study is initiated. • Any amendments to the protocol will require IRB/IEC approval before implementation of changes made to the study design, except for changes necessary to eliminate an immediate hazard to study participants. • The Investigator will notify the IRB/IEC of deviations from the study protocol or GCP as defined by UK legislation as a serious breach or as required by IRB/IEC procedures. • The Investigator will be responsible for the following: − Providing written summaries of the status of the study to the IRB/IEC annually or more frequently in accordance with the requirements, policies, and procedures established by the IRB/IEC − Notifying the IRB/IEC of SAEs or other significant safety findings as required by IRB/IEC procedures − Providing oversight of the conduct of the study at the site and adherence to requirements of 21 CFR, ICH guidelines, the IRB/IEC, European regulation 536/2014 for clinical studies (if applicable), and all other applicable local regulations

Regulatory and Ethical Considerations. This study will be conducted in accordance with the protocol and with the following: − - Consensus ethical principles derived from international guidelines including the Declaration of Helsinki and Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines − - Applicable ICH ICH/ISO Good Clinical Practice (GCP) Guidelines − guidelines - Applicable laws and regulations • The protocol, protocol amendments, ICF, IBInvestigator’s Brochure, and other relevant documents (eg, advertisements) must be submitted to an IRB/IEC by the Investigator and reviewed and approved by the IRB/IEC before the study is initiated. • Any amendments to the protocol will require IRB/IEC approval before implementation of changes made to the study design, except for changes necessary to eliminate an immediate hazard to study participants. • The Investigator will notify the IRB/IEC of deviations from the study protocol or GCP as defined by UK legislation as a serious breach or as required by IRB/IEC proceduressubjects. • The Investigator will be responsible for the following: − - Providing written summaries of the status of the study to the IRB/IEC annually or more frequently in accordance with the requirements, policies, and procedures established by the IRB/IEC − - Notifying the IRB/IEC of SAEs or other significant safety findings as required by IRB/IEC procedures − - Providing oversight of the overall conduct of the study at the site and adherence to requirements of applicable local regulations, for example 21 Code of Federal Regulations (CFR), ICH guidelines, the IRB/IEC, and European regulation 536/2014 for clinical studies (if applicable), and all other applicable local regulations

Regulatory and Ethical Considerations. This study will be conducted in accordance with the protocol and with the following: − Consensus ethical principles derived from international guidelines including the Declaration of Helsinki and Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines − Applicable ICH Good Clinical Practice (GCP) Guidelines − Applicable laws and regulations • The protocol, protocol amendments, ICF, IBInvestigator’s Brochure, and other relevant documents (eg, advertisements) must be submitted to an IRB/IEC by the Investigator and reviewed and approved by the IRB/IEC before the study is initiated. • Any amendments to the protocol will require IRB/IEC approval before implementation of changes made to the study design, except for changes necessary to eliminate an immediate hazard to study participants. • The Investigator will notify the IRB/IEC of deviations from the study protocol or GCP as defined by UK legislation as a serious breach or as required by IRB/IEC procedurespatients. • The Investigator will be responsible for the following: − Providing written summaries of the status of the study to the IRB/IEC annually or more frequently in accordance with the requirements, policies, and procedures established by the IRB/IEC − Notifying the IRB/IEC of SAEs or other significant safety findings as required by IRB/IEC procedures − Providing oversight of the conduct of the study at the site and adherence to requirements of 21 CFR, ICH guidelines, the IRB/IEC, European regulation 536/2014 for clinical studies (if applicable), and all other applicable local regulations