Common use of Obligations of the Parties and the Principal Investigator Clause in Contracts

Obligations of the Parties and the Principal Investigator. 4.1 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. 4.2 The Parties agree to adhere to the principles of medical confidentiality in relation to Clinical Trial Subjects involved in the Clinical Trial. 4.3 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 Trial. 4.4 The Principal Investigator shall be responsible for: 4.4.1 ensuring that the informed consent form, approved by the Sponsor and the relevant research ethics committee, is signed by or on behalf of each Clinical Trial Subject before the first Clinical Trial related procedure starts for that Clinical Trial Subject (or otherwise that the requirements of The European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations, S.I. No. 314 of 2018 - Data Protection Act 2018, (Section 36(2)) (Health Research) Regulations 2018 and 2004, SI No 190 of 2004 and Statutory Instrument No. 158 of 2006 (Quality and Safety of Human Tissues and Cells) Regulations, SI 99 of 2022- European Union (Clinical Trials on Medicinal Products for Human Use) (Principal) Regulations 2022 and SI No. 158 of 2006 – European Communities (Quality and Safety of Human Tissue and Cells) Regulations, as may be amended, repealed or replaced from time to time are met in accordance with the Protocol); and 4.4.2 making any necessary disclosures of financial interests and arrangements, as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 Trial as well as subsequent to Site Trial Completion, and that the Principal Investigator, 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. 4.5 The Sponsor, shall submit the Clinical Trial for listing in a free, publicly accessible clinical trial registry within twenty-one (21) days of initiation of the Clinical Trial by enrolment of the first Clinical Trial Subject. The Clinical Organisation agrees that such listing may include a summary of the Protocol, the name of the Clinical Organisation and the details of the Site(s) where the Clinical Trial is being conducted. Subject to Clause 7 of this Agreement, in the event that the Sponsor intends to publish the name of the Principal Investigator on a publicly accessible clinical trial 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 unless the Sponsor is subject to a regulatory obligation to disclose the Principal Investigator’s name, in which the Sponsor must inform the Principal Investigator about such an obligation 4.6 The Parties shall conduct the Clinical Trial in accordance with the terms of this Agreement (including the incorporated Protocol) and: 4.6.1 Any current marketing authorisation for the IMP and, as the case may be, the Clinical Trial Authorisation granted by the HPRA; and 4.6.2 the terms and conditions of the favourable opinion of the research ethics committee. 4.7 Until the Sponsor has obtained approval from the HPRA, the research ethics committee and any other necessary approvals, the Sponsor shall not supply the Investigational Drugs to the Clinical Organisation. The Clinical Organisation shall ensure that neither administration of the IMP (nor any other Investigational Drug supplied by the Sponsor for use in the Clinical Trial) to any Clinical Trial Subject nor any other clinical intervention mandated by the Protocol takes place in relation to any Clinical Trial Subject until the Clinical Organisation is satisfied that all relevant approvals have been obtained by the Sponsor. 4.8 In the event of any substantial amendments being made to the Protocol and approved by the HPRA and ethics committee 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 17.3 of this Agreement. 4.9 The Sponsor shall make the 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 Site File. The Sponsor shall ensure that any and all safety and/or toxicology data relating to the IMP, of which the Sponsor is aware or which comes to the attention of the Sponsor from time to time, and which may, in the reasonable opinion of the Sponsor, be materially relevant to the conduct of the Clinical Trial, will also be provided to the Principal Investigator for inclusion in the Site File. 4.10 The Clinical Organisation shall not, and will ensure that the Principal Investigator shall not, permit the Investigational Drugs supplied by or on behalf of the Sponsor for the purposes of the Clinical Trial to be used for any purpose other than the conduct of the Clinical Trial. Upon termination or expiry of this Agreement all unused Investigational Drugs supplied for the purposes of the Clinical Trial shall, at the Sponsor’s option, either be returned to the Sponsor or, be disposed of in accordance with the Protocol or the reasonable written instructions of the Sponsor. 4.11 Subject to the Clinical Organisation’s and the Principal Investigator’s overriding obligations in relation to Clinical Trial Subjects and individual patient care, the Clinical Organisation shall ensure that neither it nor the Principal Investigator shall during the term of this Agreement conduct any other Research that might hinder the Clinical Organisation’s or Principal Investigator’s ability to enrol and study the required cohort of Clinical Trial Subjects. 4.12 The Clinical Organisation shall use all reasonable endeavours to ensure that the Principal Investigator enrols/doses/randomises a minimum of [INSERT NUMBER] Clinical Trial Subject(s), to participate in the Clinical Trial and the Parties shall conduct the Clinical Trial in accordance with the Timelines. 4.13 In the event that the Clinical Trial is part of a Multi-Centre Trial, the Sponsor may amend the number of Clinical Trial Subjects to be enrolled pursuant to the Protocol as follows: 4.13.1 If, in the reasonable opinion of the Sponsor, enrolment of the Clinical Trial Subjects at the Clinical Organisation is proceeding at a rate below that required to enable the Timelines to be met, and upon request by the Sponsor to increase the enrolment rate, the Clinical Organisation is unable to comply, the Sponsor may by notice to the Clinical Organisation, require the Clinical Organisation to cease enrolment of Clinical Trial Subjects. 4.13.2 If, with respect of the Clinical Trial, the global enrolment target has been reached, upon receipt of a notice, the Clinical Organisation shall ensure that the Principal Investigator shall immediately stop the enrolment of Clinical Trial Subjects and the terms and conditions of this Agreement shall not apply to individuals who at the time of receipt of such notice have not signed informed consent and have not been enrolled in the Clinical Trial. Payments shall be made according to the number of Clinical Trial Subjects enrolled up to the date of receipt of the notice. 4.13.3 If enrolment of Clinical Trial Subjects is proceeding at a rate above that which is required to meet the Timelines, the Sponsor may, with the written agreement of the Clinical Organisation, increase the number of Clinical Trial Subjects to be enrolled at the Site and the payment to be made will be adjusted in accordance with Clause 17.2. 4.14

Obligations of the Parties and the Principal Investigator. 4.1 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. 4.2 The Parties agree to adhere to the principles of medical confidentiality in relation to Clinical Trial Subjects involved in the Clinical Trial. 4.3 The Sponsor [Sponsor] [and/or] [CRO] (delete as appropriate, in line with Appendix 6) 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 Trial. 4.4 CRO shall perform such of the Sponsor’s Clinical Trial related duties and functions in respect of the Clinical Trial under ICH-GCP as contained in Appendix 6. 4.5 The Principal Investigator shall be responsible for: 4.4.1 4.5.1 ensuring that the informed consent form, approved by the Sponsor [Sponsor] [and/or] [CRO] (delete as appropriate) and the relevant research ethics committee, is signed by or on behalf of each Clinical Trial Subject before the first Clinical Trial related procedure starts for that Clinical Trial Subject (or otherwise that the requirements of The European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations, S.I. No. 314 of 2018 - Data Protection Act 2018, (Section 36(2)) (Health Research) Regulations 2018 and 2004, SI No 190 of 2004 and Statutory Instrument No. 158 of 2006 (Quality and Safety of Human Tissues and Cells) Regulations, SI 99 of 2022- European Union (Clinical Trials on Medicinal Products for Human Use) (Principal) Regulations 2022 and SI No. 158 of 2006 – European Communities (Quality and Safety of Human Tissue and Cells) Regulations, as may be amended, repealed or replaced from time to time are met in accordance with the Protocol); and 4.4.2 4.5.2 making any necessary disclosures of financial interests and arrangements, as defined and requested by the Sponsor and/or CRO, provided that such disclosures may be made prior to the commencement of work activities associated with the Clinical Trial as well as subsequent to Site Trial Completion, and that the Principal Investigator, 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. 4.5 4.6 The Sponsor, either itself or through the CRO, shall submit the Clinical Trial for listing in a free, publicly accessible clinical trial registry within twenty-one (21) days of initiation of the Clinical Trial by enrolment of the first Clinical Trial Subject. The Clinical Organisation agrees that such listing may include a summary of the Protocol, the name of the Clinical Organisation and the details of the Site(s) where the Clinical Trial is being conducted. Subject to Clause 7 of this Agreement, in the event that the Sponsor or CRO intends to publish the name of the Principal Investigator on a publicly accessible clinical trial 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 unless the Sponsor is subject to a regulatory obligation to disclose the Principal Investigator’s name, in which the Sponsor must inform the Principal Investigator about such an obligation. 4.6 4.7 The Parties shall conduct the Clinical Trial in accordance with the terms of this Agreement (including the incorporated Protocol) and: 4.6.1 Any 4.7.1 any current marketing authorisation for the IMP and, as the case may be, the Clinical Trial Authorisation granted by the HPRA; and 4.6.2 4.7.2 the terms and conditions of the favourable opinion of the research ethics committee. 4.7 4.8 Until the Sponsor or CRO has obtained approval from the HPRA, the research ethics committee and any other necessary approvals, the Sponsor shall not supply supply, nor shall the Sponsor authorise CRO to supply, the Investigational Drugs to the Clinical Organisation. The Clinical Organisation shall ensure that neither administration of the IMP (nor any other Investigational Drug supplied by the Sponsor and/or CRO for use in the Clinical Trial) to any Clinical Trial Subject nor any other clinical intervention mandated by the Protocol takes place in relation to any Clinical Trial Subject until the Clinical Organisation is satisfied that Sponsor or CRO has confirmed and provided all relevant approvals have been obtained by the Sponsorapprovals. 4.8 4.9 In the event of any substantial amendments being made to the Protocol and approved by the HPRA and ethics committee 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 17.3 of this Agreement. 4.9 4.10 The Sponsor [Sponsor] [and/or] [CRO] (delete as appropriate) shall make the Protocol 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 Site File. The Sponsor [Sponsor] [and/or] [CRO] (delete as appropriate) shall ensure that any and all safety and/or toxicology data relating to the IMP, of which the Sponsor is or CRO are aware or which comes to the attention of the Sponsor or CRO from time to time, and which may, in the reasonable opinion of the SponsorSponsor or CRO, be materially relevant to the conduct of the Clinical Trial, will also be provided to the Principal Investigator for inclusion in the Site File. 4.10 4.11 The Clinical Organisation shall not, and will ensure that the Principal Investigator shall not, permit the Investigational Drugs supplied by or on behalf of the Sponsor or CRO for the purposes of the Clinical Trial to be used for any purpose other than the conduct of the Clinical Trial. Upon termination or expiry of this Agreement all unused Investigational Drugs supplied for the purposes of the Clinical Trial shall, at the Sponsor’s option, either be returned to the Sponsor oror CRO, be or disposed of in accordance with the Protocol or the reasonable written instructions of the SponsorSponsor or CRO. 4.11 4.12 Subject to the Clinical Organisation’s and the Principal Investigator’s overriding obligations in relation to Clinical Trial Subjects and individual patient care, the Clinical Organisation shall ensure that neither it nor the Principal Investigator shall during the term of this Agreement conduct any other Research that might hinder the Clinical Organisation’s or Principal Investigator’s ability to enrol and study the required cohort of Clinical Trial Subjects. 4.12 4.13 The Clinical Organisation shall use all reasonable endeavours to ensure that the Principal Investigator enrols/doses/randomises a minimum of [INSERT NUMBER] Clinical Trial Subject(s), to participate in the Clinical Trial and the Parties shall conduct the Clinical Trial in accordance with the Timelines. 4.13 4.14 In the event that the Clinical Trial is part of a Multi-Centre Trial, the Sponsor [Sponsor] [or] [CRO] (delete as appropriate) may amend the number of Clinical Trial Subjects to be enrolled pursuant to the Protocol as follows: 4.13.1 4.14.1 If, in the reasonable opinion of the [Sponsor] [or] [CRO] (delete as appropriate), enrolment of the Clinical Trial Subjects at the Clinical Organisation is proceeding at a rate below that required to enable the Timelines to be met, and upon request by the Sponsor [Sponsor] [or] [CRO] (delete as appropriate) to increase the enrolment rate, the Clinical Organisation is unable to comply, the Sponsor [Sponsor] [or] [CRO] (delete as appropriate) may by notice to the Clinical Organisation, require the Clinical Organisation to cease enrolment of Clinical Trial Subjects. 4.13.2 If, 4.14.2 If with respect of the Clinical Trial, the global enrolment target has been reached, upon receipt of a notice, the Clinical Organisation shall ensure that the Principal Investigator shall immediately stop the enrolment of Clinical Trial Subjects and the terms and conditions of this Agreement shall not apply to individuals who at the time of receipt of such notice have not signed informed consent and have not been enrolled in the Clinical Trial. Payments shall be made according to the number of Clinical Trial Subjects enrolled up to the date of receipt of the notice. 4.13.3 4.14.3 If enrolment of Clinical Trial Subjects is proceeding at a rate above that which is required to meet the Timelines, the Sponsor [Sponsor] [or] [CRO] (delete as appropriate) may, with the written agreement of the Clinical Organisation, increase the number of Clinical Trial Subjects to be enrolled at the Site and the payment to be made will be adjusted in accordance with Clause 17.2. 4.144.15