Common use of Bribery and corruption Clause in Contracts

Bribery and corruption. Each Party warrants and represents that: It has not committed any offence under the Bribery Act 2010 or any of the following acts (“Prohibited Acts”): other than in accordance with applicable laws, valid agreements and the provisions of this Agreement, offered, given or agreed to give any officer or employee of the other Party any gift or consideration of any kind, as an inducement or reward for doing or not doing or for having done or not having done any act in relation to the obtaining or performance of this Agreement or any other agreement with the other Party or for showing or not showing favour or disfavour to any person in relation to this Agreement or any other agreement with the other Party; or in connection with this Agreement, paid or agreed to pay any commission other than a payment in accordance with this Agreement that has not otherwise been disclosed in writing to the other Party. If either Party has committed or commits any of the Prohibited Acts or has committed or commits any offence under the Bribery Act 2010 in relation to this Agreement, the other Party shall be entitled to terminate this Agreement in accordance with Clause 14, in addition to any other remedy available, taking into consideration the potential effects of termination on the health of Clinical Investigation Participants. Obligations of the Parties and the Principal Investigator Each Party represents and warrants that it has the right and authority to enter into this Agreement and that it has the capability and capacity to fulfil its obligations under this Agreement. The Parties agree to adhere to the principles of medical confidentiality in relation to Clinical Investigation Participants involved in the Clinical Investigation and potential Clinical Investigation Participants. The Sponsor shall be responsible for obtaining and maintaining Regulatory Authority approval, as well as research ethics committee favourable opinion and any other approvals needed for the conduct of the Clinical Investigation. The Principal Investigator shall be responsible for: ensuring that the informed consent form, approved by the Sponsor and the relevant research ethics committee, is signed by each Clinical Investigation Participant before the first Clinical Investigation related procedure starts for that Clinical Investigation Participant, or that otherwise the arrangements as set out in the approved Clinical Investigation Plan are met for each Clinical Investigation Participant (for example, appropriate consultation under the relevant Mental Capacity Act of England and Wales or Northern Ireland / Adults With Incapacity Act of Scotland); making any necessary disclosures of financial interests and arrangements, as defined and requested by the Sponsor, provided that such disclosures may be made prior to the commencement of work activities associated with the Clinical Investigation as well as subsequent to Investigator Site Investigation Completion, and that the Principal Investigator, (all) Sub-investigator(s) and Personnel shall update such disclosures as necessary to maintain their accuracy and completeness during the term of this Agreement and for any other period required by applicable law. Subject to Clause 4.6 and Clause 4.6.1, the Sponsor shall submit the Clinical Investigation for listing in a free, publicly accessible research registry within twenty-one (21) days of initiation of the Clinical Investigation by enrolment of the first Clinical Investigation Participant. The Trial Site agrees that such listing may include a summary of the Clinical Investigation Plan, the name of the Trial Site and of any Other Trial Site(s) where the Clinical Investigation is being conducted. Subject to Clause 6 of this Agreement, in the event that the Sponsor intends to publish the name of the Principal Investigator on a publicly-accessible research registry, the Sponsor shall be responsible for obtaining the written permission of the Principal Investigator for the use of the Principal Investigator’s name (and any other personal information) in such a publication. If, having considered all the circumstances, the Sponsor is of the view that the public interest benefits of registering the Clinical Investigation on the timescale specified in Clause 4.5 are outweighed by the harm that registration at that time might do to the commercial value of the Investigational Medical Device or the commercial interests of the Sponsor, they may request the Health Research Authority (HRA) to authorise deferral of registration. [The Sponsor has not requested the HRA to authorise deferral of registration.] [The HRA has authorised Sponsor to defer registration and a copy of the authorisation is attached at Appendix 9.] The Parties shall conduct the Clinical Investigation in accordance with the terms of this Agreement (including the incorporated Clinical Investigation Plan) and: The manufacturers recommended Instructions for Use for the Investigational Medical Device; in the case of a Non-Regulated Clinical Investigation, the intended purpose for which the Investigational Medical Device has been CE Marked as detailed in the Instructions for Use; in the case of a Regulated Clinical Investigation, the Letter of No Objection to the Clinical Investigation issued by the MHRA; the terms and conditions of the favourable opinion of the research ethics committee. Until the Sponsor has obtained a letter of no objection from the MHRA (where the Clinical Investigation is a Regulated Clinical Investigation), a favourable opinion from the research ethics committee and any other necessary approvals, it shall not supply the Investigational Medical Device to the Trial Site. The Trial Site shall ensure that neither administration of the Investigational Medical Device to any Clinical Investigation Participant nor any other clinical intervention arising from the Clinical Investigation Plan takes place in relation to any Clinical Investigation Participant until it is satisfied that all relevant approvals have been obtained. In the event of any Amendments being made to the Clinical Investigation Plan, the Amendments shall be signed by the Principal Investigator and shall be implemented by the Personnel as required by the Sponsor. The Sponsor shall initiate simultaneously the change control procedures set out in Clause 16.3 of this Agreement. The Sponsor shall make the Clinical Investigation Plan available to the Principal Investigator and provide evidence of the approvals set out in Clause 4.6 and the Principal Investigator shall include such documents in the Investigator Site File. The Trial Site shall not, and will ensure that the Principal Investigator shall not, permit a Medical Device supplied by or on behalf of the Sponsor for the purposes of the Clinical Investigation to be used for any purpose other than the conduct of the Clinical Investigation. Upon termination or expiry of this Agreement the disposal or return of Investigational Medical Devices supplied by or on behalf of the Sponsor for the purposes of the Clinical Investigation shall be managed in accordance with the Clinical Investigation Plan or otherwise in accordance with the Sponsor’s reasonable written instructions. Subject to the Trial Site’s and the Principal Investigator’s overriding obligations in relation to Clinical Investigation Participants and individual patient care, the Trial Site shall ensure that neither it nor the Principal Investigator, nor the Personnel shall during the term of this Agreement conduct any other Research that might hinder the Trial Site’s or Principal Investigator’s ability to enrol and study the required cohort of Clinical Investigation Participants. The Trial Site shall use its best endeavours to ensure that the Principal Investigator enrols / randomises a minimum of [INSERT NUMBER] Clinical Investigation Participant(s), to participate in the Clinical Investigation and the Parties shall conduct the Clinical Investigation in accordance with the Timelines. In the event that the Clinical Investigation is part of a Multi-Centre Investigation, the Sponsor may amend the number of Clinical Investigation Participants to be enrolled pursuant to the Clinical Investigation Plan as follows: If, in the reasonable opinion of the Sponsor, enrolment of the Clinical Investigation Participants at the Trial Site is proceeding at a rate below that required to enable the Timelines to be met, and upon the Sponsor’s request to increase the enrolment rate, the Trial Site is unable to comply, the Sponsor may by reasonable notice to the Trial Site, require the Trial Site to cease enrolment of Clinical Investigation Participants. If, with respect of the Clinical Investigation, the global enrolment target has been reached, upon receipt of a notice, the Trial Site shall ensure that the Principal Investigator shall immediately stop the enrolment of Clinical Investigation Participants and the terms and conditions of this Agreement shall not apply to individuals who at the time of receipt of such notice have not given informed consent (where required) and have not been enrolled in the Clinical Investigation. Payments shall be made according to the number of Clinical Investigation Participants enrolled up to the date of receipt of the notice. If enrolment of Clinical Investigation Participants is proceeding at a rate above that which is required to meet the Timelines, the Sponsor may, with the written agreement of the Trial Site, increase the number of Clinical Investigation Participants to be enrolled at the Investigator Site and the payment to be made will be adjusted in accordance with Clause 16.2. The Trial Site will enter into (a) Hub and Spoke Agreement(s) with Other Trial Site(s), whose Clinical Investigation related activities are to be overseen by the Principal Investigator (such Other Trial Site(s) to have been agreed to in advance by the Sponsor) to ensure that all such Other Trial Site(s) abide by the relevant terms of this Agreement as if they were a party to it. The addition of such Other Trial Site(s) will be recorded via a variation to this Agreement.

Bribery and corruption. Each Party warrants and represents that: It has not committed any offence under the Bribery Act 2010 or any of the following acts (“Prohibited Acts”): other than in accordance with applicable laws, valid agreements and the provisions of this Agreement, offered, given or agreed to give any officer or employee of the any other Party any gift or consideration of any kind, as an inducement or reward for doing or not doing or for having done or not having done any act in relation to the obtaining or performance of this Agreement or any other agreement with the any other Party or for showing or not showing favour or disfavour to any person in relation to this Agreement or any other agreement with the any other Party; or in connection with this Agreement, paid or agreed to pay any commission other than a payment in accordance with this Agreement that has not otherwise been disclosed in writing to the any other Party. If either any Party has committed or commits any of the Prohibited Acts or has committed or commits any offence under the Bribery Act 2010 in relation to this Agreement, the then any other Party shall be entitled to terminate this Agreement in accordance with Clause 14, in addition to any other remedy available, taking into consideration the potential effects of termination on the health of Clinical Investigation Participants. Obligations of the Parties and the Principal Investigator Each Party represents and warrants that it has the right and authority to enter into this Agreement and that it has the capability and capacity to fulfil its obligations under this Agreement. The Parties agree to adhere to the principles of medical confidentiality in relation to Clinical Investigation Participants involved in the Clinical Investigation and potential Clinical Investigation Participants. The Sponsor [and / or] [CRO] (delete as appropriate, in line with Appendix 9) shall be responsible for obtaining and maintaining Regulatory Authority approval, as well as research ethics committee favourable opinion and any other approvals needed for the conduct of the Clinical Investigation. The CRO shall perform such of the Sponsor’s Clinical Investigation related duties and functions in respect of the Clinical Investigation as contained in Appendix 9. The Principal Investigator shall be responsible for: ensuring that the informed consent form, approved by the Sponsor [or CRO] and the relevant research ethics committee, is signed by each Clinical Investigation Participant before the first Clinical Investigation related procedure starts for that Clinical Investigation Participant, or that otherwise the arrangements as set out in the approved Clinical Investigation Plan are met for each Clinical Investigation Participant (for example, appropriate consultation under the relevant Mental Capacity Act of England and Wales or Northern Ireland / Adults With Incapacity Act of Scotland); making any necessary disclosures of financial interests and arrangements, as defined and requested by the SponsorSponsor and / or CRO, provided that such disclosures may be made prior to the commencement of work activities associated with the Clinical Investigation as well as subsequent to Investigator Site Investigation Completion, and that the Principal Investigator, (all) Sub-investigator(s) and Personnel shall update such disclosures as necessary to maintain their accuracy and completeness during the term of this Agreement and for any other period required by applicable law. Subject to Clause 4.6 4.7 and Clause 4.6.14.7.1, the Sponsor or CRO shall submit the Clinical Investigation for listing in a free, publicly publicly-accessible research registry within twenty-one (21) days of initiation of the Clinical Investigation by enrolment of the first Clinical Investigation Participant. The Trial Site agrees that such listing may include a summary of the Clinical Investigation Plan, the name of the Trial Site and the details of any Other Trial Site(s) where the Clinical Investigation is being conducted. Subject to Clause 6 of this Agreement, in the event that the Sponsor or CRO intends to publish the name of the Principal Investigator on a publicly-accessible research registry, the Sponsor or CRO shall be responsible for obtaining the written permission of the Principal Investigator for the use of the Principal Investigator’s name (and any other personal information) in such a publication. If, having considered all the circumstances, the Sponsor is of the view that the public interest benefits of registering the Clinical Investigation on the timescale specified in Clause 4.5 4.6 are outweighed by the harm that registration at that time might do to the commercial value of the Investigational Medical Device or the commercial interests of the Sponsor, they may request the Health Research Authority (HRA) to authorise deferral of registration. [The Sponsor has not requested the HRA to authorise deferral of registration.] [The HRA has authorised Sponsor to defer registration and a copy of the authorisation is attached at Appendix 910.] The Parties shall conduct the Clinical Investigation in accordance with the terms of this Agreement (including the incorporated Clinical Investigation Plan) and: The manufacturers recommended Instructions for Use for the Investigational Medical Device; in the case of a Non-Regulated regulated Clinical Investigation, the intended purpose for which the Investigational Medical Device has been CE Marked as detailed in the Instructions for Use; in the case of a Regulated Clinical Investigation, the Letter of No Objection to the Clinical Investigation issued by the MHRA; the terms and conditions of the favourable opinion of the research ethics committee. Until the Sponsor or CRO has obtained a letter of no objection from the MHRA (where the Clinical Investigation is a Regulated Clinical Investigation), a favourable opinion from the research ethics committee and any other necessary approvals, it shall not supply the any Investigational Medical Device Devices to the Trial Site, nor shall it authorise the Trial Site to use its own supply of Investigational Medical Devices for this Clinical Investigation. The Trial Site shall ensure that neither administration of the Investigational Medical Device to any Clinical Investigation Participant nor any other clinical intervention arising from the Clinical Investigation Plan takes place in relation to any Clinical Investigation Participant until it is satisfied that all relevant approvals have been obtained. In the event of any Amendments being made to the Clinical Investigation Plan, the Amendments shall be signed by the Principal Investigator and shall be implemented by the Personnel as required by the SponsorSponsor or CRO. The Sponsor or CRO shall initiate simultaneously the change control procedures set out in Clause 16.3 of this Agreement. The Sponsor [Sponsor] [CRO] (delete as appropriate) shall make the Clinical Investigation Plan available to the Principal Investigator and provide evidence of the approvals set out in Clause 4.6 4.8 and the Principal Investigator shall include such documents in the Investigator Site File. The Trial Site shall not, and will ensure that the Principal Investigator shall not, permit a Medical Device supplied by or on behalf of the Sponsor for the purposes of the Clinical Investigation to be used for any purpose other than the conduct of the Clinical Investigation. Upon termination or expiry of this Agreement the disposal or return of Investigational Medical Devices supplied by or on behalf of the Sponsor for the purposes of the Clinical Investigation shall be managed in accordance with the Clinical Investigation Plan or otherwise in accordance with the Sponsor’s reasonable written instructionsinstructions of the Sponsor or CRO. Subject to the Trial Site’s and the Principal Investigator’s overriding obligations in relation to Clinical Investigation Participants and individual patient care, the Trial Site shall ensure that neither it nor the Principal Investigator, nor the Personnel shall during the term of this Agreement conduct any other Research that might hinder the Trial Site’s or Principal Investigator’s ability to enrol and study the required cohort of Clinical Investigation Participants. The Trial Site shall use its best endeavours to ensure that the Principal Investigator enrols / randomises (DELETE option not applicable) [a minimum of of] (DELETE if not applicable) [INSERT NUMBER] Clinical Investigation Participant(s), to participate in the Clinical Investigation and the Parties shall conduct the Clinical Investigation in accordance with the Timelines. In the event that the Clinical Investigation is part of a Multi-Centre Investigation, the Sponsor or CRO may amend the number of Clinical Investigation Participants to be enrolled pursuant to the Clinical Investigation Plan as follows: If, in the reasonable opinion of the SponsorSponsor [or CRO], enrolment of the Clinical Investigation Participants at the Trial Site is proceeding at a rate below that required to enable the Timelines to be met, and upon request by the Sponsor’s request Sponsor or CRO to increase the enrolment rate, the Trial Site is unable to comply, the Sponsor or CRO may by reasonable notice to the Trial Site, require the Trial Site to cease enrolment of Clinical Investigation Participants. If, If with respect of the Clinical Investigation, the global enrolment target has been reached, upon receipt of a notice, the Trial Site shall ensure that the Principal Investigator shall immediately stop the enrolment of Clinical Investigation Participants and the terms and conditions of this Agreement shall not apply to individuals who at the time of receipt of such notice have not given informed consent (where required) and have not been enrolled in the Clinical Investigation. Payments shall be made according to the number of Clinical Investigation Participants enrolled up to the date of receipt of the notice. If enrolment of Clinical Investigation Participants is proceeding at a rate above that which is required to meet the Timelines, the Sponsor [or CRO] may, with the written agreement of the Trial Site, increase the number of Clinical Investigation Participants to be enrolled at the Investigator Site and the payment to be made will be adjusted in accordance with Clause 16.2. The Trial Site will enter into (a) Hub and Spoke Agreement(s) with Other Trial Site(s), whose Clinical Investigation related activities are to be overseen by the Principal Investigator (such Other Trial Site(s) to have been agreed to in advance by the Sponsor) to ensure that all such Other Trial Site(s) abide by the relevant terms of this Agreement as if they were a party to it. The addition of such Other Trial Site(s) will be recorded via a variation to this Agreement.

Bribery and corruption. Each Party warrants and represents that: It has not committed any offence under the Bribery Act 2010 or any of the following acts (“Prohibited Acts”): other than in accordance with applicable laws, valid agreements and the provisions of this Agreement, offered, given or agreed to give any officer or employee of the any other Party any gift or consideration of any kind, as an inducement or reward for doing or not doing or for having done or not having done any act in relation to the obtaining or performance of this Agreement or any other agreement with the any other Party or for showing or not showing favour or disfavour to any person in relation to this Agreement or any other agreement with the any other Party; or in connection with this Agreement, paid or agreed to pay any commission other than a payment in accordance with this Agreement that has not otherwise been disclosed in writing to the any other Party. If either any Party has committed or commits any of the Prohibited Acts or has committed or commits any offence under the Bribery Act 2010 in relation to this Agreement, the then any other Party shall be entitled to terminate this Agreement in accordance with Clause 14, in addition to any other remedy available, taking into consideration the potential effects of termination on the health of Clinical Investigation Participants. Obligations of the Parties and the Principal Investigator Each Party represents and warrants that it has the right and authority to enter into this Agreement and that it has the capability and capacity to fulfil its obligations under this Agreement. The Parties agree to adhere to the principles of medical confidentiality in relation to Clinical Investigation Participants involved in the Clinical Investigation and potential Clinical Investigation Participants. The Sponsor [and / or] [CRO] (delete as appropriate, in line with Appendix 9) shall be responsible for obtaining and maintaining Regulatory Authority approval, as well as research ethics committee favourable opinion and any other approvals needed for the conduct of the Clinical Investigation. The CRO shall perform such of the Sponsor’s Clinical Investigation related duties and functions in respect of the Clinical Investigation as contained in Appendix 9. The Principal Investigator shall be responsible for: ensuring that the informed consent form, approved by the Sponsor [or CRO] and the relevant research ethics committee, is signed by each Clinical Investigation Participant before the first Clinical Investigation related procedure starts for that Clinical Investigation Participant, or that otherwise the arrangements as set out in the approved Clinical Investigation Plan are met for each Clinical Investigation Participant (for example, appropriate consultation under the relevant Mental Capacity Act of England and Wales or Northern Ireland / Adults With Incapacity Act of Scotland); making any necessary disclosures of financial interests and arrangements, as defined and requested by the SponsorSponsor and / or CRO, provided that such disclosures may be made prior to the commencement of work activities associated with the Clinical Investigation as well as subsequent to Investigator Site Investigation Completion, and that the Principal Investigator, (all) Sub-investigator(s) and Personnel shall update such disclosures as necessary to maintain their accuracy and completeness during the term of this Agreement and for any other period required by applicable law. Subject to Clause 4.6 4.7 and Clause 4.6.14.7.1, the Sponsor or CRO shall submit the Clinical Investigation for listing in a free, publicly publicly-accessible research registry within twenty-one (21) days of initiation of the Clinical Investigation by enrolment of the first Clinical Investigation Participant. The Trial Site agrees that such listing may include a summary of the Clinical Investigation Plan, the name of the Trial Site and the details of any Other Trial Site(s) where the Clinical Investigation is being conducted. Subject to Clause 6 of this Agreement, in the event that the Sponsor or CRO intends to publish the name of the Principal Investigator on a publicly-accessible research registry, the Sponsor or CRO shall be responsible for obtaining the written permission of the Principal Investigator for the use of the Principal Investigator’s name (and any other personal information) in such a publication. If, having considered all the circumstances, the Sponsor is of the view that the public interest benefits of registering the Clinical Investigation on the timescale specified in Clause 4.5 4.6 are outweighed by the harm that registration at that time might do to the commercial value of the Investigational Medical Device or the commercial interests of the Sponsor, they may request the Health Research Authority (HRA) to authorise deferral of registration. [The Sponsor has not requested the HRA to authorise deferral of registration.] [The HRA has authorised Sponsor to defer registration and a copy of the authorisation is attached at Appendix 910.] The Parties shall conduct the Clinical Investigation in accordance with the terms of this Agreement (including the incorporated Clinical Investigation Plan) and: The manufacturers recommended Instructions for Use for the Investigational Medical Device; in the case of a Non-Regulated regulated Clinical Investigation, the intended purpose for which the Investigational Medical Device has been CE Marked as detailed in the Instructions for Use; in the case of a Regulated Clinical Investigation, the Letter of No Objection to the Clinical Investigation issued by the MHRA; the terms and conditions of the favourable opinion of the research ethics committee. Until the Sponsor or CRO has obtained a letter of no objection from the MHRA (where the Clinical Investigation is a Regulated Clinical Investigation), a favourable opinion from the research ethics committee and any other necessary approvals, it shall not supply the any Investigational Medical Device Devices to the Trial Site, nor shall it authorise the Trial Site to use its own supply of Investigational Medical Devices for this Clinical Investigation. The Trial Site shall ensure that neither administration of the Investigational Medical Device to any Clinical Investigation Participant nor any other clinical intervention arising from the Clinical Investigation Plan takes place in relation to any Clinical Investigation Participant until it is satisfied that all relevant approvals have been obtained. In the event of any Amendments being made to the Clinical Investigation Plan, the Amendments shall be signed by the Principal Investigator and shall be implemented by the Personnel as required by the SponsorSponsor or CRO. The Sponsor or CRO shall initiate simultaneously the change control procedures set out in Clause 16.3 of this Agreement. The Sponsor [Sponsor] [CRO] (delete as appropriate) shall make the Clinical Investigation Plan available to the Principal Investigator and provide evidence of the approvals set out in Clause 4.6 4.8 and the Principal Investigator shall include such documents in the Investigator Site File. The Trial Site shall not, and will ensure that the Principal Investigator shall not, permit a Medical Device supplied by or on behalf of the Sponsor for the purposes of the Clinical Investigation to be used for any purpose other than the conduct of the Clinical Investigation. Upon termination or expiry of this Agreement the disposal or return of Investigational Medical Devices supplied by or on behalf of the Sponsor for the purposes of the Clinical Investigation shall be managed in accordance with the Clinical Investigation Plan or otherwise in accordance with the Sponsor’s reasonable written instructionsinstructions of the Sponsor or CRO. Subject to the Trial Site’s and the Principal Investigator’s overriding obligations in relation to Clinical Investigation Participants and individual patient care, the Trial Site shall ensure that neither it nor the Principal Investigator, nor the Personnel shall during the term of this Agreement conduct any other Research that might hinder the Trial Site’s or Principal Investigator’s ability to enrol and study the required cohort of Clinical Investigation Participants. The Trial Site shall use its best endeavours to ensure that the Principal Investigator enrols [enrols] / randomises [randomises] (DELETE option not applicable) [a minimum of of] (DELETE if not applicable) [INSERT NUMBER] Clinical Investigation Participant(s), to participate in the Clinical Investigation and the Parties shall conduct the Clinical Investigation in accordance with the Timelines. In the event that the Clinical Investigation is part of a Multi-Centre Investigation, the Sponsor or CRO may amend the number of Clinical Investigation Participants to be enrolled [enrolled] / [randomised] pursuant to the Clinical Investigation Plan as follows: If, in the reasonable opinion of the SponsorSponsor [or CRO], enrolment [enrolment] / [randomisation] of the Clinical Investigation Participants at the Trial Site is proceeding at a rate below that required to enable the Timelines to be met, and upon request by the Sponsor’s request Sponsor or CRO to increase the enrolment [enrolment] / [randomisation] rate, the Trial Site is unable to comply, the Sponsor or CRO may by reasonable notice to the Trial Site, require the Trial Site to cease enrolment of Clinical Investigation Participants. If, If with respect of the Clinical Investigation, the global enrolment target has been reached, upon receipt of a notice, the Trial Site shall ensure that the Principal Investigator shall immediately stop the enrolment of Clinical Investigation Participants and the terms and conditions of this Agreement shall not apply to individuals who at the time of receipt of such notice have not given informed consent (where required) and have not been enrolled in the Clinical Investigation. Payments shall be made according to the number of Clinical Investigation Participants enrolled up to the date of receipt of the notice. If enrolment [enrolment] / [randomisation] of Clinical Investigation Participants is proceeding at a rate above that which is required to meet the Timelines, the Sponsor [or CRO] may, with the written agreement of the Trial Site, increase the number of Clinical Investigation Participants to be enrolled [enrolled] / [randomised] at the Investigator Site and the payment to be made will be adjusted in accordance with Clause 16.2. The Trial Site will enter into (a) Hub and Spoke Agreement(s) with Other Trial Site(s), whose Clinical Investigation related activities are to be overseen by the Principal Investigator (such Other Trial Site(s) to have been agreed to in advance by the Sponsor) to ensure that all such Other Trial Site(s) abide by the relevant terms of this Agreement as if they were a party to it. The addition of such Other Trial Site(s) will be recorded via a variation to this Agreement.

Bribery and corruption. Each Party warrants and represents that: It has not committed any offence under the Bribery Act 2010 or any of the following acts (“Prohibited Acts”): other than in accordance with applicable laws, valid agreements and the provisions of this Agreement, offered, given or agreed to give any officer or employee of the other Party any gift or consideration of any kind, as an inducement or reward for doing or not doing or for having done or not having done any act in relation to the obtaining or performance of this Agreement or any other agreement with the other Party or for showing or not showing favour or disfavour to any person in relation to this Agreement or any other agreement with the other Party; or in connection with this Agreement, paid or agreed to pay any commission other than a payment in accordance with this Agreement that has not otherwise been disclosed in writing to the other Party. If either Party has committed or commits any of the Prohibited Acts or has committed or commits any offence under the Bribery Act 2010 in relation to this Agreement, the other Party shall be entitled to terminate this Agreement in accordance with Clause 14, in addition to any other remedy available, taking into consideration the potential effects of termination on the health of Clinical Investigation Participants. Obligations of the Parties and the Principal Investigator Each Party represents and warrants that it has the right and authority to enter into this Agreement and that it has the capability and capacity to fulfil its obligations under this Agreement. The Parties agree to adhere to the principles of medical confidentiality in relation to Clinical Investigation Participants involved in the Clinical Investigation and potential Clinical Investigation Participants. The Sponsor shall be responsible for obtaining and maintaining Regulatory Authority approval, as well as research ethics committee favourable opinion and any other approvals needed for the conduct of the Clinical Investigation. The Principal Investigator shall be responsible for: ensuring that the informed consent form, approved by the Sponsor and the relevant research ethics committee, is signed by each Clinical Investigation Participant before the first Clinical Investigation related procedure starts for that Clinical Investigation Participant, or that otherwise the arrangements as set out in the approved Clinical Investigation Plan are met for each Clinical Investigation Participant (for example, appropriate consultation under the relevant Mental Capacity Act of England and Wales or Northern Ireland / Adults With Incapacity Act of Scotland); making any necessary disclosures of financial interests and arrangements, as defined and requested by the Sponsor, provided that such disclosures may be made prior to the commencement of work activities associated with the Clinical Investigation as well as subsequent to Investigator Site Investigation Completion, and that the Principal Investigator, (all) Sub-investigator(s) and Personnel shall update such disclosures as necessary to maintain their accuracy and completeness during the term of this Agreement and for any other period required by applicable law. Subject to Clause 4.6 and Clause 4.6.1, the Sponsor shall submit the Clinical Investigation for listing in a free, publicly accessible research registry within twenty-one (21) days of initiation of the Clinical Investigation by enrolment of the first Clinical Investigation Participant. The Trial Site agrees that such listing may include a summary of the Clinical Investigation Plan, the name of the Trial Site and of any Other Trial Site(s) where the Clinical Investigation is being conducted. Subject to Clause 6 of this Agreement, in the event that the Sponsor intends to publish the name of the Principal Investigator on a publicly-accessible research registry, the Sponsor shall be responsible for obtaining the written permission of the Principal Investigator for the use of the Principal Investigator’s name (and any other personal information) in such a publication. If, having considered all the circumstances, the Sponsor is of the view that the public interest benefits of registering the Clinical Investigation on the timescale specified in Clause 4.5 are outweighed by the harm that registration at that time might do to the commercial value of the Investigational Medical Device or the commercial interests of the Sponsor, they may request the Health Research Authority (HRA) to authorise deferral of registration. [The Sponsor has not requested the HRA to authorise deferral of registration.] [The HRA has authorised Sponsor to defer registration and a copy of the authorisation is attached at Appendix 9.] The Parties shall conduct the Clinical Investigation in accordance with the terms of this Agreement (including the incorporated Clinical Investigation Plan) and: The manufacturers recommended Instructions for Use for the Investigational Medical Device; in the case of a Non-Regulated Clinical Investigation, the intended purpose for which the Investigational Medical Device has been CE Marked as detailed in the Instructions for Use; in the case of a Regulated Clinical Investigation, the Letter of No Objection to the Clinical Investigation issued by the MHRA; the terms and conditions of the favourable opinion of the research ethics committee. Until the Sponsor has obtained a letter of no objection from the MHRA (where the Clinical Investigation is a Regulated Clinical Investigation), a favourable opinion from the research ethics committee and any other necessary approvals, it shall not supply the Investigational Medical Device to the Trial Site, nor shall it authorise the Trial Site to use its own supply of Investigational Medical Devices for this Clinical Investigation. The Trial Site shall ensure that neither administration of the Investigational Medical Device to any Clinical Investigation Participant nor any other clinical intervention arising from the Clinical Investigation Plan takes place in relation to any Clinical Investigation Participant until it is satisfied that all relevant approvals have been obtained. In the event of any Amendments being made to the Clinical Investigation Plan, the Amendments shall be signed by the Principal Investigator and shall be implemented by the Personnel as required by the Sponsor. The Sponsor shall initiate simultaneously the change control procedures set out in Clause 16.3 of this Agreement. The Sponsor shall make the Clinical Investigation Plan available to the Principal Investigator and provide evidence of the approvals set out in Clause 4.6 4.7 and the Principal Investigator shall include such documents in the Investigator Site File. The Trial Site shall not, and will ensure that the Principal Investigator shall not, permit a Medical Device supplied by or on behalf of the Sponsor for the purposes of the Clinical Investigation to be used for any purpose other than the conduct of the Clinical Investigation. Upon termination or expiry of this Agreement the disposal or return of Investigational Medical Devices supplied by or on behalf of the Sponsor for the purposes of the Clinical Investigation shall be managed in accordance with the Clinical Investigation Plan or otherwise in accordance with the Sponsor’s reasonable written instructions. Subject to the Trial Site’s and the Principal Investigator’s overriding obligations in relation to Clinical Investigation Participants and individual patient care, the Trial Site shall ensure that neither it nor the Principal Investigator, nor the Personnel shall during the term of this Agreement conduct any other Research that might hinder the Trial Site’s or Principal Investigator’s ability to enrol and study the required cohort of Clinical Investigation Participants. The Trial Site shall use its best endeavours to ensure that the Principal Investigator enrols [enrols] / randomises [randomises] (DELETE OPTIONS NOT APPLICABLE) (a minimum of of) (DELETE IF NOT APPLICABLE) [INSERT NUMBER] Clinical Investigation Participant(s), to participate in the Clinical Investigation and the Parties shall conduct the Clinical Investigation in accordance with the Timelines. In the event that the Clinical Investigation is part of a Multi-Centre Investigation, the Sponsor may amend the number of Clinical Investigation Participants to be enrolled [enrolled] / [randomised] pursuant to the Clinical Investigation Plan as follows: If, in the reasonable opinion of the Sponsor, enrolment [enrolment] / [randomisation] of the Clinical Investigation Participants at the Trial Site is proceeding at a rate below that required to enable the Timelines to be met, and upon the Sponsor’s request to increase the enrolment [enrolment] / [randomisation] rate, the Trial Site is unable to comply, the Sponsor may by reasonable notice to the Trial Site, require the Trial Site to cease enrolment of Clinical Investigation Participants. If, with respect of the Clinical Investigation, the global enrolment target has been reached, upon receipt of a notice, the Trial Site shall ensure that the Principal Investigator shall immediately stop the enrolment of Clinical Investigation Participants and the terms and conditions of this Agreement shall not apply to individuals who at the time of receipt of such notice have not given informed consent (where required) and have not been enrolled in the Clinical Investigation. Payments shall be made according to the number of Clinical Investigation Participants enrolled up to the date of receipt of the notice. If enrolment [enrolment] / [randomisation] of Clinical Investigation Participants is proceeding at a rate above that which is required to meet the Timelines, the Sponsor may, with the written agreement of the Trial Site, increase the number of Clinical Investigation Participants to be enrolled [enrolled] / [randomised] at the Investigator Site and the payment to be made will be adjusted in accordance with Clause 16.2. The Trial Site will enter into (a) Hub and Spoke Agreement(s) with Other Trial Site(s), whose Clinical Investigation related activities are to be overseen by the Principal Investigator (such Other Trial Site(s) to have been agreed to in advance by the Sponsor) to ensure that all such Other Trial Site(s) abide by the relevant terms of this Agreement as if they were a party to it. The addition of such Other Trial Site(s) will be recorded via a variation to this Agreement.

Bribery and corruption. Each Party warrants and represents that: It has not committed any offence under the Bribery Act 2010 or any of the following acts (“Prohibited Acts”): other than in accordance with applicable laws, valid agreements and the provisions of this Agreement, offered, given or agreed to give any officer or employee of the other Party any gift or consideration of any kind, as an inducement or reward for doing or not doing or for having done or not having done any act in relation to the obtaining or performance of this Agreement or any other agreement with the other Party or for showing or not showing favour or disfavour to any person in relation to this Agreement or any other agreement with the other Party; or in connection with this Agreement, paid or agreed to pay any commission other than a payment in accordance with this Agreement that has not otherwise been disclosed in writing to the other Party. If either Party has committed or commits any of the Prohibited Acts or has committed or commits any offence under the Bribery Act 2010 in relation to this Agreement, the other Party shall be entitled to terminate this Agreement in accordance with Clause 14, in addition to any other remedy available, taking into consideration the potential effects of termination on the health of Clinical Investigation Participants. Obligations of the Parties and the Principal Investigator Each Party represents and warrants that it has the right and authority to enter into this Agreement and that it has the capability and capacity to fulfil its obligations under this Agreement. The Parties agree to adhere to the principles of medical confidentiality in relation to Clinical Investigation Participants involved in the Clinical Investigation and potential Clinical Investigation Participants. The Sponsor shall be responsible for obtaining and maintaining Regulatory Authority approval, as well as research ethics committee favourable opinion and any other approvals needed for the conduct of the Clinical Investigation. The Principal Investigator shall be responsible for: ensuring that the informed consent form, approved by the Sponsor and the relevant research ethics committee, is signed by each Clinical Investigation Participant before the first Clinical Investigation related procedure starts for that Clinical Investigation Participant, or that otherwise the arrangements as set out in the approved Clinical Investigation Plan are met for each Clinical Investigation Participant (for example, appropriate consultation under the relevant Mental Capacity Act of England and Wales or Northern Ireland / Adults With Incapacity Act of Scotland); making any necessary disclosures of financial interests and arrangements, as defined and requested by the Sponsor, provided that such disclosures may be made prior to the commencement of work activities associated with the Clinical Investigation as well as subsequent to Investigator Site Investigation Completion, and that the Principal Investigator, (all) Sub-investigator(s) and Personnel shall update such disclosures as necessary to maintain their accuracy and completeness during the term of this Agreement and for any other period required by applicable law. Subject to Clause 4.6 and Clause 4.6.1, the Sponsor shall submit the Clinical Investigation for listing in a free, publicly accessible research registry within twenty-one (21) days of initiation of the Clinical Investigation by enrolment of the first Clinical Investigation Participant. The Trial Site agrees that such listing may include a summary of the Clinical Investigation Plan, the name of the Trial Site and of any Other Trial Site(s) where the Clinical Investigation is being conducted. Subject to Clause 6 of this Agreement, in the event that the Sponsor intends to publish the name of the Principal Investigator on a publicly-accessible research registry, the Sponsor shall be responsible for obtaining the written permission of the Principal Investigator for the use of the Principal Investigator’s name (and any other personal information) in such a publication. If, having considered all the circumstances, the Sponsor is of the view that the public interest benefits of registering the Clinical Investigation on the timescale specified in Clause 4.5 are outweighed by the harm that registration at that time might do to the commercial value of the Investigational Medical Device or the commercial interests of the Sponsor, they may request the Health Research Authority (HRA) to authorise deferral of registration. [The Sponsor has not requested the HRA to authorise deferral of registration.] [The HRA has authorised Sponsor to defer registration and a copy of the authorisation is attached at Appendix 9.] The Parties shall conduct the Clinical Investigation in accordance with the terms of this Agreement (including the incorporated Clinical Investigation Plan) and: The manufacturers recommended Instructions for Use for the Investigational Medical Device; in the case of a Non-Regulated Clinical Investigation, the intended purpose for which the Investigational Medical Device has been CE Marked as detailed in the Instructions for Use; in the case of a Regulated Clinical Investigation, the Letter of No Objection to the Clinical Investigation issued by the MHRA; the terms and conditions of the favourable opinion of the research ethics committee. Until the Sponsor has obtained a letter of no objection from the MHRA (where the Clinical Investigation is a Regulated Clinical Investigation), a favourable opinion from the research ethics committee and any other necessary approvals, it shall not supply the Investigational Medical Device to the Trial Site, nor shall it authorise the Trial Site to use its own supply of Investigational Medical Devices for this Clinical Investigation. The Trial Site shall ensure that neither administration of the Investigational Medical Device to any Clinical Investigation Participant nor any other clinical intervention arising from the Clinical Investigation Plan takes place in relation to any Clinical Investigation Participant until it is satisfied that all relevant approvals have been obtained. In the event of any Amendments being made to the Clinical Investigation Plan, the Amendments shall be signed by the Principal Investigator and shall be implemented by the Personnel as required by the Sponsor. The Sponsor shall initiate simultaneously the change control procedures set out in Clause 16.3 of this Agreement. The Sponsor shall make the Clinical Investigation Plan available to the Principal Investigator and provide evidence of the approvals set out in Clause 4.6 4.7 and the Principal Investigator shall include such documents in the Investigator Site File. The Trial Site shall not, and will ensure that the Principal Investigator shall not, permit a Medical Device supplied by or on behalf of the Sponsor for the purposes of the Clinical Investigation to be used for any purpose other than the conduct of the Clinical Investigation. Upon termination or expiry of this Agreement the disposal or return of Investigational Medical Devices supplied by or on behalf of the Sponsor for the purposes of the Clinical Investigation shall be managed in accordance with the Clinical Investigation Plan or otherwise in accordance with the Sponsor’s reasonable written instructions. Subject to the Trial Site’s and the Principal Investigator’s overriding obligations in relation to Clinical Investigation Participants and individual patient care, the Trial Site shall ensure that neither it nor the Principal Investigator, nor the Personnel shall during the term of this Agreement conduct any other Research that might hinder the Trial Site’s or Principal Investigator’s ability to enrol and study the required cohort of Clinical Investigation Participants. The Trial Site shall use its best endeavours to ensure that the Principal Investigator enrols / randomises (DELETE OPTIONS NOT APPLICABLE) (a minimum of of) (DELETE IF NOT APPLICABLE) [INSERT NUMBER] Clinical Investigation Participant(s), to participate in the Clinical Investigation and the Parties shall conduct the Clinical Investigation in accordance with the Timelines. In the event that the Clinical Investigation is part of a Multi-Centre Investigation, the Sponsor may amend the number of Clinical Investigation Participants to be enrolled pursuant to the Clinical Investigation Plan as follows: If, in the reasonable opinion of the Sponsor, enrolment of the Clinical Investigation Participants at the Trial Site is proceeding at a rate below that required to enable the Timelines to be met, and upon the Sponsor’s request to increase the enrolment rate, the Trial Site is unable to comply, the Sponsor may by reasonable notice to the Trial Site, require the Trial Site to cease enrolment of Clinical Investigation Participants. If, with respect of the Clinical Investigation, the global enrolment target has been reached, upon receipt of a notice, the Trial Site shall ensure that the Principal Investigator shall immediately stop the enrolment of Clinical Investigation Participants and the terms and conditions of this Agreement shall not apply to individuals who at the time of receipt of such notice have not given informed consent (where required) and have not been enrolled in the Clinical Investigation. Payments shall be made according to the number of Clinical Investigation Participants enrolled up to the date of receipt of the notice. If enrolment of Clinical Investigation Participants is proceeding at a rate above that which is required to meet the Timelines, the Sponsor may, with the written agreement of the Trial Site, increase the number of Clinical Investigation Participants to be enrolled at the Investigator Site and the payment to be made will be adjusted in accordance with Clause 16.2. The Trial Site will enter into (a) Hub and Spoke Agreement(s) with Other Trial Site(s), whose Clinical Investigation related activities are to be overseen by the Principal Investigator (such Other Trial Site(s) to have been agreed to in advance by the Sponsor) to ensure that all such Other Trial Site(s) abide by the relevant terms of this Agreement as if they were a party to it. The addition of such Other Trial Site(s) will be recorded via a variation to this Agreement.

Bribery and corruption. Each Party The Contractor represents and warrants that neither it, nor to the best of its knowledge any Contractor Personnel, any person acting on their behalf, have at any time prior to the Commencement Date: committed a Prohibited Act or been formally notified that it is subject to an investigation or prosecution which relates to an alleged Prohibited Act; and/or been listed by any government department or agency as being debarred, suspended, proposed for suspension or debarment, or otherwise ineligible for participation in government procurement programmes or the Agreement on the grounds of a Prohibited Act. The Contractor, Contractor Personnel, or any person acting on their behalf shall not during the Term: commit a Prohibited Act; and/or do or suffer anything to be done which would cause Pegasys or any of Pegasys’s employees, consultants, suppliers, Agreement and/or any subcontractors or agents to contravene any of the Relevant Requirements or otherwise incur any liability in relation to the Relevant Requirements. The Contractor shall during the Term: establish, maintain and enforce, and require that its Contractor Personnel establish, maintain and enforce, policies and procedures which are adequate to ensure compliance with the Relevant Requirements and prevent the occurrence of a Prohibited Act; The Contractor shall immediately notify Pegasys in writing if it becomes aware of any breach of Clause S.1 and/or Clause S.2, or has reason to believe that it has or any Contractor Personnel, servants, agents or Subcontractors, or any person acting on their behalf have: been subject to an investigation or prosecution which relates to an alleged Prohibited Act; been listed by any government department or agency as being debarred, suspended, proposed for suspension or debarment, or otherwise ineligible for participation in government procurement programmes or Agreement on the grounds of a Prohibited Act; and/or received a request or demand for any undue financial or other advantage of any kind in connection with the performance of this Agreement or otherwise suspects that any person or party directly or indirectly connected with this Agreement has committed or attempted to commit a Prohibited Act. The Contractor warrants and represents that: It has not committed any offence under to Pegasys that to the Bribery Act 2010 best of its knowledge, that neither the Contractor, Contractor Personnel, servants, agents or sub-agreement and/or Sub-Contractors, or any of the following acts (“Prohibited Acts”): other than in accordance with applicable lawsperson acting on their behalf: has given, valid agreements and the provisions of this Agreement, offered, given offered or agreed to give any officer or employee of the other Party accepted, any gift or consideration of any kind, kind as an inducement or reward for doing or not doing for bearing to do or for having done or not having done forborne to do any act in relation to the obtaining or performance execution of this any Sub-Agreement or and/or any other agreement with the other Party Call Down Subcontract or for showing or not showing forbearing to show favour or disfavour to any person or entity in relation to any Sub-Agreement and/or any Call Down Subcontract; or has entered into any agreement in connection with which commission has been paid or agreed to be paid by or to the Contractor or Contractor Personnel or on their behalf or to their knowledge unless, before such agreement was made, particulars of any such commission and of the terms of any agreement for the payment of such commission were disclosed in writing to Pegasys, whose written consent was subsequently given to such payment. Where the Contractor or Contractor Personnel, or any person acting on their behalf, does any of the acts mentioned in Clause S.5 or commits any offence under the HMG Xxxxxxx Xxx 0000, with or without the knowledge of the Contractor, in relation to this Agreement or any other agreement with the other Party; Pegasys or in connection with this AgreementHMG, paid or agreed to pay any commission other than a payment in accordance with this Agreement that has not otherwise been disclosed in writing to the other Party. If either Party has committed or commits any of the Prohibited Acts or has committed or commits any offence under the Bribery Act 2010 in relation to this Agreement, the other Party Pegasys shall be entitled entitled: to terminate this the Agreement in accordance with Clause 14, in addition to any other remedy available, taking into consideration the potential effects of termination on the health of Clinical Investigation Participants. Obligations of the Parties and the Principal Investigator Each Party represents and warrants that it has the right and authority to enter into this Agreement and that it has the capability and capacity to fulfil its obligations under this Agreement. The Parties agree to adhere to the principles of medical confidentiality in relation to Clinical Investigation Participants involved in the Clinical Investigation and potential Clinical Investigation Participants. The Sponsor shall be responsible for obtaining and maintaining Regulatory Authority approval, as well as research ethics committee favourable opinion and any other approvals needed for the conduct of the Clinical Investigation. The Principal Investigator shall be responsible for: ensuring that the informed consent form, approved immediate effect by the Sponsor and the relevant research ethics committee, is signed by each Clinical Investigation Participant before the first Clinical Investigation related procedure starts for that Clinical Investigation Participant, or that otherwise the arrangements as set out in the approved Clinical Investigation Plan are met for each Clinical Investigation Participant (for example, appropriate consultation under the relevant Mental Capacity Act of England and Wales or Northern Ireland / Adults With Incapacity Act of Scotland); making any necessary disclosures of financial interests and arrangements, as defined and requested by the Sponsor, provided that such disclosures may be made prior to the commencement of work activities associated with the Clinical Investigation as well as subsequent to Investigator Site Investigation Completion, and that the Principal Investigator, (all) Sub-investigator(s) and Personnel shall update such disclosures as necessary to maintain their accuracy and completeness during the term of this Agreement and for any other period required by applicable law. Subject to Clause 4.6 and Clause 4.6.1, the Sponsor shall submit the Clinical Investigation for listing in a free, publicly accessible research registry within twenty-one (21) days of initiation of the Clinical Investigation by enrolment of the first Clinical Investigation Participant. The Trial Site agrees that such listing may include a summary of the Clinical Investigation Plan, the name of the Trial Site and of any Other Trial Site(s) where the Clinical Investigation is being conducted. Subject to Clause 6 of this Agreement, in the event that the Sponsor intends to publish the name of the Principal Investigator on a publicly-accessible research registry, the Sponsor shall be responsible for obtaining the written permission of the Principal Investigator for the use of the Principal Investigator’s name (and any other personal information) in such a publication. If, having considered all the circumstances, the Sponsor is of the view that the public interest benefits of registering the Clinical Investigation on the timescale specified in Clause 4.5 are outweighed by the harm that registration at that time might do to the commercial value of the Investigational Medical Device or the commercial interests of the Sponsor, they may request the Health Research Authority (HRA) to authorise deferral of registration. [The Sponsor has not requested the HRA to authorise deferral of registration.] [The HRA has authorised Sponsor to defer registration and a copy of the authorisation is attached at Appendix 9.] The Parties shall conduct the Clinical Investigation in accordance with the terms of this Agreement (including the incorporated Clinical Investigation Plan) and: The manufacturers recommended Instructions for Use for the Investigational Medical Device; in the case of a Non-Regulated Clinical Investigation, the intended purpose for which the Investigational Medical Device has been CE Marked as detailed in the Instructions for Use; in the case of a Regulated Clinical Investigation, the Letter of No Objection to the Clinical Investigation issued by the MHRA; the terms and conditions of the favourable opinion of the research ethics committee. Until the Sponsor has obtained a letter of no objection from the MHRA (where the Clinical Investigation is a Regulated Clinical Investigation), a favourable opinion from the research ethics committee and any other necessary approvals, it shall not supply the Investigational Medical Device to the Trial Site. The Trial Site shall ensure that neither administration of the Investigational Medical Device to any Clinical Investigation Participant nor any other clinical intervention arising from the Clinical Investigation Plan takes place in relation to any Clinical Investigation Participant until it is satisfied that all relevant approvals have been obtained. In the event of any Amendments being made to the Clinical Investigation Plan, the Amendments shall be signed by the Principal Investigator and shall be implemented by the Personnel as required by the Sponsor. The Sponsor shall initiate simultaneously the change control procedures set out in Clause 16.3 of this Agreement. The Sponsor shall make the Clinical Investigation Plan available to the Principal Investigator and provide evidence of the approvals set out in Clause 4.6 and the Principal Investigator shall include such documents in the Investigator Site File. The Trial Site shall not, and will ensure that the Principal Investigator shall not, permit a Medical Device supplied by or on behalf of the Sponsor for the purposes of the Clinical Investigation to be used for any purpose other than the conduct of the Clinical Investigation. Upon termination or expiry of this Agreement the disposal or return of Investigational Medical Devices supplied by or on behalf of the Sponsor for the purposes of the Clinical Investigation shall be managed in accordance with the Clinical Investigation Plan or otherwise in accordance with the Sponsor’s reasonable written instructions. Subject to the Trial Site’s and the Principal Investigator’s overriding obligations in relation to Clinical Investigation Participants and individual patient care, the Trial Site shall ensure that neither it nor the Principal Investigator, nor the Personnel shall during the term of this Agreement conduct any other Research that might hinder the Trial Site’s or Principal Investigator’s ability to enrol and study the required cohort of Clinical Investigation Participants. The Trial Site shall use its best endeavours to ensure that the Principal Investigator enrols / randomises a minimum of [INSERT NUMBER] Clinical Investigation Participant(s), to participate in the Clinical Investigation and the Parties shall conduct the Clinical Investigation in accordance with the Timelines. In the event that the Clinical Investigation is part of a Multi-Centre Investigation, the Sponsor may amend the number of Clinical Investigation Participants to be enrolled pursuant to the Clinical Investigation Plan as follows: If, in the reasonable opinion of the Sponsor, enrolment of the Clinical Investigation Participants at the Trial Site is proceeding at a rate below that required to enable the Timelines to be met, and upon the Sponsor’s request to increase the enrolment rate, the Trial Site is unable to comply, the Sponsor may by reasonable notice to the Trial SiteContractor and recover from the Contractor the amount of any Losses resulting from the termination; to recover from the Contractor the amount or value of any such gift, require consideration or commission; to recover from the Trial Site Contractor any other losses sustained as a result of any breach of this Clause S, whether or not the Agreement is terminated. Pegasys, the Contractor and the Contractor Personnel shall immediately and without undue delay inform each other of any event that interferes or threatens to cease enrolment of Clinical Investigation Participants. If, materially interfere with respect the successful delivery of the Clinical InvestigationServices, the global enrolment target has been reachedwhether financed in full or in part by Pegasys, upon receipt of a noticeincluding credible suspicion of/or actual fraud, the Trial Site shall ensure that the Principal Investigator shall immediately stop the enrolment of Clinical Investigation Participants and the terms and conditions of this Agreement shall not apply to individuals who at the time of receipt of such notice have not given informed consent (where required) and have not been enrolled in the Clinical Investigation. Payments shall be made according to the number of Clinical Investigation Participants enrolled up to the date of receipt of the notice. If enrolment of Clinical Investigation Participants is proceeding at a rate above that which is required to meet the Timelinesbribery, the Sponsor may, with the written agreement of the Trial Site, increase the number of Clinical Investigation Participants to be enrolled at the Investigator Site and the payment to be made will be adjusted in accordance with Clause 16.2. The Trial Site will enter into (a) Hub and Spoke Agreement(s) with Other Trial Site(s), whose Clinical Investigation related activities are to be overseen by the Principal Investigator (such Other Trial Site(s) to have been agreed to in advance by the Sponsor) to ensure that all such Other Trial Site(s) abide by the relevant terms of this Agreement as if they were a party to it. The addition of such Other Trial Site(s) will be recorded via a variation to this Agreementcorruption or any other financial irregularity or impropriety.

Bribery and corruption. Each Party warrants and represents that: It has not committed any offence under the Bribery Act 2010 or any of the following acts (“Prohibited Acts”): other than in accordance with applicable laws, valid agreements and the provisions of this Agreement, offered, given or agreed to give any officer or employee of the other Party any gift or consideration of any kind, as an inducement or reward for doing or not doing or for having done or not having done any act in relation to the obtaining or performance of this Agreement or any other agreement with the other Party or for showing or not showing favour or disfavour to any person in relation to this Agreement or any other agreement with the other Party; or in connection with this Agreement, paid or agreed to pay any commission other than a payment in accordance with this Agreement that has not otherwise been disclosed in writing to the other Party. If either Party has committed or commits any of the Prohibited Acts or has committed or commits any offence under the Bribery Act 2010 in relation to this Agreement, the other Party shall be entitled to terminate this Agreement in accordance with Clause 14, in addition to any other remedy available, taking into consideration the potential effects of termination on the health of Clinical Investigation Participants. Obligations of the Parties and the Principal Investigator Each Party represents and warrants that it has the right and authority to enter into this Agreement and that it has the capability and capacity to fulfil its obligations under this Agreement. The Parties agree to adhere to the principles of medical confidentiality in relation to Clinical Investigation Participants involved in the Clinical Investigation and potential Clinical Investigation ParticipantsNon-Interventional Study. The Where required, the Sponsor shall be responsible for obtaining and maintaining a Regulatory Authority approval, as well as research ethics committee favourable opinion and any other approvals needed for the conduct of the Clinical InvestigationNon-Interventional Study. The Principal Investigator shall be responsible for: ensuring that where required, the appropriate informed consent form, approved by the Sponsor and the relevant research ethics committee, is signed by or on behalf of each Clinical Investigation Participant before the first Clinical Investigation Non-Interventional Study related procedure starts for that Clinical Investigation Participant, or that otherwise the arrangements as set out in the approved Clinical Investigation Plan are met for each Clinical Investigation Participant (for example, appropriate consultation under the relevant Mental Capacity Act of England and Wales or Northern Ireland / Adults With Incapacity Act of Scotland); making any necessary disclosures of financial interests and arrangements, as defined and requested by the Sponsor, provided that such disclosures may be made prior to the commencement of work activities associated with the Clinical Investigation Non-Interventional Study as well as subsequent to Investigator Site Investigation Study Completion, and that the Principal Investigator, (all) Sub-investigator(s) and Personnel shall update such disclosures as necessary to maintain their accuracy and completeness during the term of this Agreement and for any other period required by applicable law. Subject to Clause 4.6 and Clause 4.6.1As detailed in the applicable Code of Practice, the Sponsor shall submit the Clinical Investigation Non-Interventional Study for listing in a free, publicly accessible research registry within twenty-one (21) days of initiation of the Clinical Investigation Non-Interventional Study by enrolment [enrolment] [access to the Personal Data and / or Material] (delete as applicable) of the first Clinical Investigation Participant. The Trial Site Participating Organisation agrees that such listing may include a summary of the Clinical Investigation PlanProtocol, the name of the Trial Site Participating Organisation and the details of any Other Trial the Site(s) where the Clinical Investigation Non-Interventional Study is being conducted. Subject to Clause 6 of this Agreement, in the event that the Sponsor intends to publish the name of the Principal Investigator on a publicly-publicly accessible research registry, the Sponsor shall be responsible for obtaining the written permission of the Principal Investigator for the use of the Principal Investigator’s name (and any other personal information) in such a publication. If, having considered all the circumstances, the Sponsor is of the view that the public interest benefits of registering the Clinical Investigation on the timescale specified in Clause 4.5 are outweighed by the harm that registration at that time might do to the commercial value of the Investigational Medical Device or the commercial interests of the Sponsor, they may request the Health Research Authority (HRA) to authorise deferral of registration. [The Sponsor has not requested the HRA to authorise deferral of registration.] [The HRA has authorised Sponsor to defer registration and a copy of the authorisation is attached at Appendix 9.] The Parties shall conduct the Clinical Investigation Non-Interventional Study in accordance with the terms of this Agreement (including the incorporated Clinical Investigation PlanProtocol) and: The manufacturers recommended Instructions for Use for the Investigational Medical Device; in the case of a Non-Regulated Clinical Investigation, the intended purpose for which the Investigational Medical Device has been CE Marked as detailed in the Instructions for Use; in the case of a Regulated Clinical Investigationwhere required, the Letter of No Objection to the Clinical Investigation issued by the MHRA; the terms and conditions of the favourable opinion of the research ethics committee. Until the Sponsor has obtained a letter of no objection from the MHRA (where the Clinical Investigation is a Regulated Clinical Investigation), a favourable opinion approval from the research ethics committee (if required) and any other necessary approvals, it shall not supply commence the Non-Interventional Study at the Participating Organisation, nor shall it authorise the Participating Organisation to commence the Non-Investigational Medical Device to Study at the Trial SiteParticipating Organisation. The Trial Site Participating Organisation shall ensure that neither administration of no activity mandated by the Investigational Medical Device to any Clinical Investigation Participant nor any other clinical intervention arising from the Clinical Investigation Plan Protocol takes place in relation to any Clinical Investigation Participant until it is satisfied that all relevant approvals have been obtained. In the event of any Amendments substantial amendments being made to the Clinical Investigation PlanProtocol, the Amendments amendments shall be signed by the Principal Investigator and shall be implemented by the Personnel as required by the Sponsor. The Sponsor shall initiate simultaneously the change control procedures set out in Clause 16.3 of this Agreement. The Sponsor shall make the Clinical Investigation Plan Protocol available to the Principal Investigator and provide evidence of the approvals set out in Clause 4.6 and the Principal Investigator shall include such documents in the Investigator Site File. The Trial Site Sponsor shall not, and will ensure that any and all information of which the Principal Investigator shall notSponsor is aware, permit a Medical Device supplied by or on behalf which comes to the attention of the Sponsor for from time to time, and which may, in the purposes reasonable opinion of the Clinical Investigation Sponsor, be materially relevant to be used for any purpose other than the conduct of the Clinical Investigation. Upon termination or expiry of this Agreement Non-Interventional Study, will also be provided to the disposal or return of Investigational Medical Devices supplied by or on behalf of Principal Investigator for inclusion in the Sponsor for the purposes of the Clinical Investigation shall be managed in accordance with the Clinical Investigation Plan or otherwise in accordance with the Sponsor’s reasonable written instructionsSite File. Subject to the Trial SiteParticipating Organisation’s and the Principal Investigator’s overriding obligations in relation to Clinical Investigation Participants and individual patient care, the Trial Site Participating Organisation shall ensure that neither it nor the Principal Investigator, nor the Personnel shall during the term of this Agreement conduct any other Research that might hinder the Trial SiteParticipating Organisation’s or Principal Investigator’s ability to [enrol and and] study the required cohort of Clinical Investigation Participants. The Trial Site Participating Organisation shall use its best endeavours to ensure that the Principal Investigator enrols [enrols] [includes the Personal Data and / randomises or Material] (delete option not applicable) [a minimum of of] (DELETE if not applicable) [INSERT NUMBER] Clinical Investigation Participant(s), to participate in the Clinical Investigation Non-Interventional Study and the Parties shall conduct the Clinical Investigation Non-Interventional Study in accordance with the Timelines. In the event that the Clinical Investigation Non-Interventional Study is part of a Multi-Centre InvestigationStudy, the Sponsor may amend the number of Clinical Investigation Participants to be enrolled [enrolled] [included] (delete as applicable) pursuant to the Clinical Investigation Plan Protocol as follows: If, If in the reasonable opinion of the Sponsor, enrolment [enrolment] [inclusion] (delete as applicable) of the Clinical Investigation Participants at the Trial Site Participating Organisation is proceeding at a rate below that required to enable the Timelines to be met, and upon the Sponsor’s request to increase [the enrolment rate] [the rate of Personal Data records being Processed and / or Material samples being processed] (delete as applicable), the Trial Site Participating Organisation is unable to comply, the Sponsor may by reasonable notice to the Trial SiteParticipating Organisation, require the Trial Site Participating Organisation to cease enrolment [enrolment] [inclusion] (delete as applicable) of Clinical Investigation Participants. If, If with respect of the Clinical InvestigationNon-Interventional Study, the global enrolment [enrolment] [inclusion] (delete as applicable) target has been reached, upon receipt of a notice, the Trial Site Participating Organisation shall ensure that the Principal Investigator shall immediately stop the enrolment [enrolment] [inclusion] (delete as applicable) of Clinical Investigation Participants and the terms and conditions of this Agreement shall not apply to individuals who at the time of receipt of such notice have not given signed informed consent (consent, where required) , and have not been enrolled [enrolled] [included] (delete as applicable) in the Clinical InvestigationNon-Interventional Study. Payments shall be made according to the number of Clinical Investigation Participants enrolled [enrolled] [included] (delete as applicable) up to the date of receipt of the notice. If enrolment [enrolment] [inclusion] (delete as applicable) of Clinical Investigation Participants is proceeding at a rate above that which is required to meet the Timelines, the Sponsor may, with the written agreement of the Trial SiteParticipating Organisation, increase the number of Clinical Investigation Participants to be enrolled [enrolled] [included] (delete as applicable) at the Investigator Site and the payment to be made will be adjusted in accordance with Clause 16.2. The Trial Site will enter into (a) Hub and Spoke Agreement(s) with Other Trial Site(s), whose Clinical Investigation related activities are to be overseen by the Principal Investigator (such Other Trial Site(s) to have been agreed to in advance by the Sponsor) to ensure that all such Other Trial Site(s) abide by the relevant terms of this Agreement as if they were a party to it. The addition of such Other Trial Site(s) will be recorded via a variation to this Agreement.