Common use of Obligations and Responsibilities Clause in Contracts

Obligations and Responsibilities. The Institution is responsible for ensuring that the Principal Investigator: (1) thoroughly familiarises themselves with the appropriate use of the Investigational Product(s), as described in the Protocol, Investigator’s Brochure, information relating to the Investigational Product and any other information sources provided by the Sponsor; (2) ensures written approval has been obtained to conduct the Study from the Reviewing HREC and the Institution prior to Study initiation. Written documentation of approval by the Reviewing HREC and the Institution must be provided to the Sponsor; (3) conducts the Study according to the Protocol without changes, except as provided in clause 2.2 or 2.3, or as agreed to in writing by the Sponsor and the Institution and approved in accordance with clause 3.3(5); (4) completes (and obtains completion from relevant Personnel) and returns to the Sponsor a statement of financial disclosure (an example that meets this requirement is Food and Drug Administration Form 3455 ‘Disclosure: Financial Interests and Arrangements of Clinical Investigators) before the commencement of the Study and as otherwise required, and consents to the disclosure of the completed form to overseas regulatory agencies, if required; (5) ensures that any amendments to the Protocol are approved by the Reviewing HREC and Sponsor prior to implementation of the amendment; (6) ensures that the Sponsor’s prior written consent is obtained to any advertisement in respect of the Study; (7) provides the Sponsor with evidence of the Principal Investigator’s qualifications through a current curriculum vitae and/or other relevant documentation and a list of appropriately qualified persons to whom they have delegated significant Study-related duties, if required; (8) uses their best endeavours to recruit the target number of Study Participants, within the recruitment period, specified in Schedule 1, provided that if the overall target number of Study Participants for the Study is reached, the Sponsor may direct the Institution to cease recruitment; (9) is available when a clinical research representative of the Sponsor visits the Study Site, as mutually agreed prior to the visit, and is contactable by telephone or electronic mail as frequently as is reasonably required; (10) notifies the Sponsor, the Institution and the Reviewing HREC of any Adverse Events (including Serious Adverse Events) that occur during the course of the Study in accordance with the Protocol and relevant ethical and regulatory guidelines, and, in the case of the Institution and the Reviewing HREC, with their policies and procedures; (11) completes Case Report Forms within the agreed time period. The Principal Investigator will ensure that Study Participants’ identifying information are removed from all records being transferred to the Sponsor; (12) provides regular written progress reports to the Sponsor in relation to the Study as required by the Protocol; (13) completes and returns to the Sponsor as required any Study related materials within a reasonable time period; (14) is not subject to any obligations, either contractually or in any other way, which would unreasonably interfere with or prohibit the performance of work related to this Study; and (15) ensures that informed consent to participate in the Study is obtained from each Study Participant prior to their enrolment in the Study and documented using an information and consent document which has been reviewed and approved by the Sponsor, the Institution and the Reviewing HREC.

Obligations and Responsibilities. The Institution is responsible for ensuring that the Principal Investigator: (1) thoroughly familiarises themselves himself or herself with the appropriate use of the Investigational Product(s), as described in the Protocol, Investigator’s Brochure, information relating to the Investigational Product and any other information sources provided by the Sponsor; (2) ensures written approval has been obtained to conduct the Study from the Reviewing Responsible HREC and the Institution prior to Study initiation. Written documentation of approval by the Reviewing Responsible HREC and the Institution must be provided to the Sponsor; (3) conducts the Study according to the Protocol without changes, changes except as provided in clause 2.2 or 2.32.2, or as agreed to in writing by the Sponsor and the Institution and approved in accordance with clause 3.3(5); (4) completes (and obtains completion from relevant Personnel) and returns to the Sponsor a statement of financial disclosure (an example that meets this requirement is Food and Drug Administration Form 3455 ‘Disclosure: Financial Interests and Arrangements of Clinical Investigators) before the commencement of the Study and as otherwise required, required and consents to the disclosure of the completed form to overseas regulatory agencies, if required; (5) ensures that any amendments to the Protocol are approved by the Reviewing Responsible HREC and Sponsor prior to implementation of the amendment; (6) ensures that the Sponsor’s prior written consent is obtained to any advertisement in respect of the Study; (7) provides the Sponsor with evidence of the Principal Investigator’s qualifications through a current curriculum vitae and/or other relevant documentation and a list of appropriately qualified persons to whom they have delegated significant Study-related duties, if required; (8) uses their his or her best endeavours to recruit the target number of Study ParticipantsSubjects, within the recruitment period, specified in Schedule 1, provided that if the overall target number of Study Participants Subjects for the Study is reached, the Sponsor may direct the Institution to cease recruitment; (9) is available when a clinical research representative of the Sponsor visits the Study Site, as mutually agreed prior to the visit, and is contactable by telephone or electronic mail as frequently as is reasonably required; (10) notifies the Sponsor, the Institution and the Reviewing Responsible HREC of any Adverse Events (including Serious Adverse Events) that occur during the course of the Study in accordance with the Protocol Protocol, and relevant ethical and regulatory guidelines, and, and in the case of the Institution and the Reviewing HREC, Responsible HREC with their policies and procedures; (11) completes Case Report Forms within the agreed time period. The Principal Investigator will ensure that Study ParticipantsSubjects’ identifying information are removed from all records being transferred to the Sponsor; (12) provides regular written progress reports to the Sponsor in relation to the Study as required by the Protocol; (13) completes and returns to the Sponsor as required any Study related materials within a reasonable time period; (14) is not subject to any obligations, either contractually or in any other way, which would unreasonably interfere with or prohibit the performance of work related to this Study; and (15) ensures that informed consent to participate in the Study is obtained from each Study Participant Subject prior to their enrolment in the Study and documented using an information and consent document which has been reviewed and approved by the Sponsor, the Institution and the Reviewing Responsible HREC.

Obligations and Responsibilities. The Institution is responsible for ensuring that the Principal Investigator: (1) thoroughly familiarises themselves himself or herself with the appropriate use of the Investigational Product(s), including the Instructions for use, as described in the ProtocolClinical Investigation Plan, Clinical Investigator’s Brochure, information relating to the Investigational Product and any other information sources provided by the Sponsor; (2) ensures written approval has been obtained to conduct the Study from the Reviewing Responsible HREC and the Institution prior to Study initiation. Written documentation of approval by the Reviewing Responsible HREC and the Institution must be provided to the Sponsor; (3) conducts the Study according to the Protocol Clinical Investigation Plan without changes, changes except as provided in clause 2.2 or 2.32.2, or as agreed to in writing by the Sponsor and the Institution and approved in accordance with clause 3.3(5); (4) completes (and obtains completion from relevant Personnel) and returns to the Sponsor a statement of financial disclosure (an example that meets this requirement is Food and Drug Administration Form 3455 ‘Disclosure: Financial Interests and Arrangements of Clinical Investigators) before the commencement of the Study and as otherwise required, required and consents to the disclosure of the completed form to overseas regulatory agencies, if required; (5) ensures that any amendments to the Protocol Clinical Investigation Plan are approved by the Reviewing Responsible HREC and Sponsor prior to implementation of the amendment; (6) ensures that the Sponsor’s prior written consent is obtained to any advertisement in respect of the Study; (7) provides the Sponsor with evidence of the Principal Investigator’s qualifications through a current curriculum vitae and/or other relevant documentation and a list of appropriately qualified persons to whom they have delegated significant Study-related duties, if required; (8) uses their his or her best endeavours to recruit the target number of Study ParticipantsSubjects, within the recruitment period, specified in Schedule 1, provided that if the overall target number of Study Participants Subjects for the Study is reached, the Sponsor may direct the Institution to cease recruitment; (9) is available when a clinical research representative of the Sponsor visits the Study Site, as mutually agreed prior to the visit, and is contactable by telephone or electronic mail as frequently as is reasonably required; (10) notifies the Sponsor, the Institution and the Reviewing Responsible HREC of any Adverse Events (including Serious Adverse Events) that occur during the course of the Study in accordance with the Protocol Clinical Investigation Plan, and relevant ethical and regulatory guidelines, and, and in the case of the Institution and the Reviewing HREC, Responsible HREC with their policies and procedures; (11) completes Case Report Forms within the agreed time period. The Principal Investigator will ensure that Study ParticipantsSubjects’ identifying information are removed from all records being transferred to the Sponsor; (12) provides regular written progress reports to the Sponsor in relation to the Study as required by the ProtocolClinical Investigation Plan; (13) completes and returns to the Sponsor as required any Study related materials within a reasonable time period; (14) is not subject to any obligations, either contractually or in any other way, which would unreasonably interfere with or prohibit the performance of work related to this Study; and (15) ensures that informed consent to participate in the Study is obtained from each Study Participant Subject prior to their enrolment in the Study and documented using an information and consent document which has been reviewed and approved by the Sponsor, the Institution and the Reviewing Responsible HREC.

Obligations and Responsibilities. The Without limiting any other obligations the Institution has under this agreement or at law, the Institution is responsible for ensuring that the Principal Investigator: (1a) thoroughly familiarises themselves himself or herself with the appropriate use of the Investigational Product(s), as described in the Protocol, Investigator’s Brochure, information relating to the Investigational Product and any other information sources provided by the SponsorJDRF; (2b) ensures written approval has been obtained to conduct the Study from the Reviewing HREC and the Institution prior to Study initiation. Written documentation of approval by the Reviewing HREC and the Institution must be provided to the SponsorJDRF; (3c) conducts the Study according to the Protocol without changes, except as provided in clause 2.2 or 2.3, or as agreed to in writing by the Sponsor JDRF and the Institution and approved in accordance with clause 3.3(53.3(d); (4) completes (and obtains completion from relevant Personnel) and returns to the Sponsor a statement of financial disclosure (an example that meets this requirement is Food and Drug Administration Form 3455 ‘Disclosure: Financial Interests and Arrangements of Clinical Investigators) before the commencement of the Study and as otherwise required, and consents to the disclosure of the completed form to overseas regulatory agencies, if required; (5d) ensures that any amendments to the Protocol are approved by the Reviewing HREC and Sponsor JDRF prior to implementation of the amendment; (6e) ensures that as soon as is practical advises JDRF if the Sponsor’s prior written consent is obtained to any advertisement in respect Responsible HREC alters its approval of the Study; (7f) obtains prior written approval from JDRF and the Responsible HREC of any proposed advertisements to be used for the purpose of Study Participant recruitment in the Study; (g) provides the Sponsor JDRF with evidence of the Principal Investigator’s qualifications through a current curriculum vitae and/or other relevant documentation and a list of appropriately qualified persons to whom they have delegated significant Study-related duties, if required; (8) h) uses their his or her best endeavours to recruit the target number of Study Participants, within Participants in accordance with the recruitment period, specified in Schedule 1, provided that if Research Proposal and the overall target number of Study Participants for the Study is reached, the Sponsor may direct the Institution to cease recruitmentProtocol; (9i) is available when a clinical research representative of the Sponsor JDRF visits the Study Site, as mutually agreed prior to the visit, and is contactable by telephone or electronic mail as frequently as is reasonably required; (10j) notifies the SponsorJDRF, the Institution and the Reviewing HREC of any Adverse Events (including Serious Adverse Events) that occur during the course of the Study in accordance with the Protocol Protocol, and relevant ethical and regulatory guidelines, and, and in the case of the Institution and the Reviewing HREC, HREC with their policies and procedures; (11k) completes Case Report Forms within in accordance with the agreed time periodResearch Proposal and the Protocol, and before Study Completion. The Principal Investigator will ensure that Study Participants’ identifying information are removed from all records being transferred to the SponsorJDRF; (12l) provides regular written progress and final reports to the Sponsor JDRF in relation to the Study as required by the Protocolthis agreement; (13m) completes and returns to the Sponsor JDRF as required any Study related materials within a reasonable time period; (14n) is not subject to any obligations, either contractually or in any other way, which would unreasonably interfere with or prohibit the performance of work related to this Study; and; (15o) ensures that informed consent to participate in the Study is obtained from each Study Participant prior to their enrolment in the Study and documented using an information and consent document which has been reviewed and approved by the SponsorJDRF, the Institution and the Reviewing HREC; and (p) is aware of and complies with the IP Policies, including in relation to data sharing and biosample sharing.

Obligations and Responsibilities. The Institution is responsible for ensuring that the Principal Investigator: (1) thoroughly familiarises themselves with the appropriate use of the Investigational Product(s), as described in the Protocol, Investigator’s Brochure, information relating to the Investigational Product and any other information sources provided by the Sponsor;Sponsor;‌ (2) ensures written approval has been obtained to conduct the Study from the Reviewing HREC and the Institution prior to Study initiation. Written documentation of approval by the Reviewing HREC and the Institution must be provided to the Sponsor; (3) conducts the Study according to the Protocol without changes, except as provided in clause 2.2 or 2.3, or as agreed to in writing by the Sponsor and the Institution and approved in accordance with clause 3.3(5); (4) completes (and obtains completion from relevant Personnel) and returns to the Sponsor a statement of financial disclosure (an example that meets this requirement is Food and Drug Administration Form 3455 ‘Disclosure: Financial Interests and Arrangements of Clinical Investigators) before the commencement of the Study and as otherwise required, and consents to the disclosure of the completed form to overseas regulatory agencies, if required; (5) ensures that any amendments to the Protocol are approved by the Reviewing HREC and Sponsor prior to implementation of the amendment; (6) ensures that the Sponsor’s prior written consent is obtained to any advertisement in respect of the Study;Study;‌ (7) provides the Sponsor with evidence of the Principal Investigator’s qualifications through a current curriculum vitae and/or other relevant documentation and a list of appropriately qualified persons to whom they have delegated significant Study-related duties, if required; (8) uses their best endeavours to recruit the target number of Study Participants, within the recruitment period, specified in Schedule 1, provided that if the overall target number of Study Participants for the Study is reached, the Sponsor may direct the Institution to cease recruitment;recruitment;‌ (9) is available when a clinical research representative of the Sponsor visits the Study Site, as mutually agreed prior to the visit, and is contactable by telephone or electronic mail as frequently as is reasonably required; (10) notifies the Sponsor, the Institution and the Reviewing HREC of any Adverse Events (including Serious Adverse Events) that occur during the course of the Study in accordance with the Protocol and relevant ethical and regulatory guidelines, and, in the case of the Institution and the Reviewing HREC, with their policies and procedures; (11) completes Case Report Forms within the agreed time period. The Principal Investigator will ensure that Study Participants’ identifying information are removed from all records being transferred to the Sponsor;Sponsor;‌ (12) provides regular written progress reports to the Sponsor in relation to the Study as required by the Protocol; (13) completes and returns to the Sponsor as required any Study related materials within a reasonable time period; (14) is not subject to any obligations, either contractually or in any other way, which would unreasonably interfere with or prohibit the performance of work related to this Study; andand‌ (15) ensures that informed consent to participate in the Study is obtained from each Study Participant prior to their enrolment in the Study and documented using an information and consent document which has been reviewed and approved by the Sponsor, the Institution and the Reviewing HREC.