Common use of CLINICAL TRIAL GOVERNANCE AND COMPLIANCE Clause in Contracts

CLINICAL TRIAL GOVERNANCE AND COMPLIANCE. The Sponsor shall be responsible for obtaining and maintaining Clinical Trial Authorisation for the Clinical Trial and substantial amendments to the Protocol. The Sponsor may require the Principal Investigator to apply for the Clinical Trial Authorisation for Sponsor, in which case the Principal Investigator shall keep the Sponsor fully apprised of the progress of Ethics Committee submissions and shall upon request provide the Sponsor with all correspondence relating to such submissions. The Principal Investigator shall not consent to any change in the Protocol requested by the Ethics Committee or Competent Authority without the prior written consent of the Sponsor. In the event of any substantial amendments being made to the Protocol, the amendments shall be signed by the Principal Investigator and shall be implemented by the Research Staff as required by the Sponsor or CRO after approval of the amendments by the Competent Authority and a favourable opinion of the Ethics Committee. The Clinical Trial shall be performed at the Trial Site. The Principal Investigator shall be responsible for obtaining authorization from the representatives of the Trial Site to perform the Clinical Trial at the Trial Site, which shall include but not be limited to the engagement of sub-investigators, to the extent applicable the pharmacist of the Institution (unless a separate Pharmacy Agreement is made as set out in article 7.1 below), clinical chemists, and the Research Staff required to perform the Clinical Trial as set out in this Agreement. The Sponsor shall submit the Clinical Trial for listing on a free, publicly accessible clinical trial registry like xxx.xxxxxxxxxxxxxx.xxx or on websites managed by a registry conforming to WHO standards (xxxx://xxx.xxx.xxx/ictrp/network/criteria_summary/en/index.html) after Clinical Trial Authorization. Upon request of the Institution or the Principal Investigator the Sponsor will disclose the registry and the date of submission. The Parties shall conduct the Clinical Trial in accordance with: the Agreement; the Protocol; the terms and conditions of the Clinical Trial Authorisation granted by the Competent Authority and the opinion of the Ethics Committee; and the applicable Law. The Site Parties shall make and retain records regarding the Clinical Trial as required by the Protocol, applicable Law, and in accordance with the Institution’s standard archiving procedures. Institution will retain such records for a minimum of fifteen (15) years from the date of database closure. At least ninety (90) days prior to the expiry of such retention period, Sponsor will contact Institution. If requested by Sponsor, Institution shall retain the records for a longer period of time at Sponsor’s expense. The Site Parties shall notify Sponsor immediately (not later than 24 hours) of any serious adverse events in accordance with the Protocol and applicable law and guidelines, and will cooperate with Sponsor in connection with any reports or filings related to such serious adverse event.

CLINICAL TRIAL GOVERNANCE AND COMPLIANCE. The Sponsor shall be responsible for obtaining and maintaining Clinical Trial Authorisation for the Clinical Trial and substantial amendments to the Protocol. The Sponsor may require require, by written notice the Principal Investigator to apply for the Clinical Trial Authorisation for Sponsor, in which case the Principal Investigator shall keep the Sponsor fully apprised of the progress of Ethics Committee submissions and shall upon request provide the Sponsor with all correspondence relating to such submissions. The Principal Investigator shall not consent to any change in the Protocol requested by the Ethics Committee or Competent Authority without the prior written consent of the Sponsor. In the event of any substantial amendments being made to the Protocol, the amendments shall be signed by the Principal Investigator and shall be implemented by the Research Staff as required by the Sponsor or CRO after approval of the amendments by the Competent Authority and a favourable opinion of the Ethics Committee. The Clinical Trial shall be performed at the Trial Site. The Principal Investigator shall be responsible for obtaining authorization from the representatives of the Trial Site to perform the Clinical Trial at the Trial Site, which shall include but not be limited to the engagement of sub-investigators, to the extent applicable the pharmacist of the Institution (unless a separate Pharmacy Agreement is made as set out in article 7.1 below), clinical chemists, and the Research Staff required to perform the Clinical Trial as set out in this Agreement. The Sponsor shall submit the Clinical Trial for listing on a free, publicly accessible clinical trial registry like xxx.xxxxxxxxxxxxxx.xxx or on websites managed by a registry conforming to WHO standards (xxxx://xxx.xxx.xxx/ictrp/network/criteria_summary/en/index.html) after Clinical Trial Authorization. Upon request of the Institution or the Principal Investigator the Sponsor will disclose the registry and the date of submission. The Parties shall conduct the Clinical Trial in accordance with: the Agreement; the Protocol; the terms and conditions of the Clinical Trial Authorisation granted by the Competent Authority and the opinion of the Ethics Committee; and the applicable Law. The Site Parties shall make and retain records regarding the Clinical Trial as required by the Protocol, applicable Law, and in accordance with the Institution’s standard archiving procedures. Institution will retain such records for a minimum of fifteen (15) years from time as put out in the date of database closureapplicable Law. At least ninety (90) days prior to the expiry of such retention period, Sponsor will contact Institution. If requested indicated by SponsorSponsor that such is reasonably required for regulatory purposes, Institution shall retain the records for a longer period of time at Sponsor’s expense. The Site Parties shall notify Sponsor immediately (not later than 24 hours) of any serious adverse events in accordance with the Protocol and applicable law and guidelinesLaw, and will cooperate with Sponsor in connection with any reports or filings related to such serious adverse event.

CLINICAL TRIAL GOVERNANCE AND COMPLIANCE. The Sponsor shall be responsible for obtaining and maintaining Clinical Trial Authorisation for the Clinical Trial and substantial amendments to the Protocol. The Sponsor may require the Principal Investigator to apply for the Clinical Trial Authorisation for Sponsor, in which case the Principal Investigator shall keep the Sponsor fully apprised of the progress of Ethics Committee submissions and shall upon request provide the Sponsor with all correspondence relating to such submissions. The Principal Investigator shall not consent to any change in the Protocol requested by the Ethics Committee or Competent Authority without the prior written consent of the Sponsor. In the event of any substantial amendments being made to the Protocol, the amendments shall be signed by the Principal Investigator and shall be implemented by the Research Staff as required by the Sponsor or CRO after approval of the amendments by the Competent Authority and a favourable opinion of the Ethics Committee. The Clinical Trial shall be performed at the Trial Site. The Principal Investigator shall be responsible for obtaining authorization from the representatives of the Trial Site to perform the Clinical Trial at the Trial Site, which shall include but not be limited to the engagement of sub-investigators, to the extent applicable the pharmacist of the Institution (unless a separate Pharmacy Agreement is made as set out in article 7.1 below), clinical chemists, and the Research Staff required to perform the Clinical Trial as set out in this Agreement. The Sponsor shall submit the Clinical Trial for listing on a free, publicly accessible clinical trial registry like xxx.xxxxxxxxxxxxxx.xxx or on websites managed by a registry conforming to WHO standards (xxxx://xxx.xxx.xxx/ictrp/network/criteria_summary/en/index.html) after Clinical Trial Authorization. Upon request of the Institution or the Principal Investigator the Sponsor will disclose the registry and the date of submission. The Parties shall conduct the Clinical Trial in accordance with: the Agreement; the Protocol; the terms and conditions of the Clinical Trial Authorisation granted by the Competent Authority and the opinion of the Ethics Committee; and the applicable Law. The Site Parties shall make and retain records regarding the Clinical Trial as required by the Protocol, applicable Law, and in accordance with the Institution’s standard archiving procedures. Institution will retain such records for a minimum of fifteen (15) years from the date of database closure. At least ninety (90) days prior to the expiry of such retention period, Sponsor will contact Institution. If requested by Sponsor, Institution shall retain the records for a longer period of time at Sponsor’s expense. The Site Parties shall notify Sponsor immediately (not later than 24 hours) of any serious adverse events in accordance with the Protocol and applicable law and guidelines, and will cooperate with Sponsor in connection with any reports or filings related to such serious adverse event.

CLINICAL TRIAL GOVERNANCE AND COMPLIANCE. The Sponsor shall be responsible for obtaining and maintaining Clinical Trial Authorisation Authorization for the conduct of the Clinical Trial and substantial amendments to the Protocol. The Sponsor may require the Institution and Principal Investigator to apply for the Clinical Trial Authorisation for SponsorAuthorisation, in which case the Principal Investigator shall keep the Sponsor fully apprised of the progress of the Ethics Committee submissions and shall upon request provide the Sponsor with all correspondence relating to such submissions. The Principal Investigator shall not consent to any change in the Protocol requested by the an Ethics Committee or Competent Authority nor implement any deviation from, or changes of the Protocol without the prior written consent of the Sponsor. In the event of any substantial amendments being made to the Protocol, the amendments shall be signed by the Principal Investigator and shall be implemented by the Research Staff as required by Sponsor and, to the Sponsor extent required by applicable law or CRO after ICH GCP, the prior review and documented approval of the amendments by competent authority(ies) and the Competent Authority and a favourable opinion of from the Ethics Committee. The Clinical Trial shall be performed at the Trial Site. The Principal Investigator shall be responsible for obtaining authorization from the representatives of the Trial Site to perform the Clinical Trial at the Trial Site, which shall include but not be limited to the engagement of sub-investigators, to the extent applicable the pharmacist of the Institution (unless a separate Pharmacy Agreement is made as set out in article 7.1 below), clinical chemists, and the Research Staff required to perform the Clinical Trial as set out in this Agreement. The Sponsor shall submit the Clinical Trial for listing on in a free, publicly accessible clinical trial registry like xxx.xxxxxxxxxxxxxx.xxx or on websites managed by a registry conforming to WHO standards (xxxx://xxx.xxx.xxx/ictrp/network/criteria_summary/en/index.html) after Clinical Trial AuthorizationAuthorisation. Upon request of the Neither Institution or nor the Principal Investigator shall register either the Clinical Trial, or the results, on any publicly accessible clinical trial registry, unless otherwise agreed with the Sponsor. Sponsor will disclose the registry shall inform Institution and the date Principal Investigator about the name and telephone number of submissionthe Trial Monitor and the name of the person who will be available as a point of contact. Sponsor shall also provide the Principal Investigator with an emergency number to enable adverse event reporting at any time. The Parties and the Principal Investigator shall conduct the Clinical Trial in accordance with: the Agreement; the Protocol; the terms and conditions of the Clinical Trial Authorisation granted by the Ethics Committee and Competent Authority and the opinion of the Ethics CommitteeAuthority; and the applicable Lawlegal and regulatory requirement(s). The Site Parties and the Principal Investigator shall make comply with all relevant laws and retain records regulations of the EU if directly applicable or of direct effect and all relevant laws and regulations of The Netherlands including but not limited to, the (Dutch) Medical Research Involving Human Subjects Act (“WMO”), the (Dutch) Personal Data Protection Act (“Wbp”), the (Dutch) Act on the Agreement regarding Medical Treatment (“WGBO”), the Clinical Trial as required by (Dutch) law on Safety and Quality of Human Material (“Wet Veiligheid en Kwaliteit Lichaamsmateriaal”) and with all relevant guidance relating to medicines, use of human tissue and clinical trials from time to time in force including, but not limited to, the Protocol, applicable Law, ICH GCP and in accordance with the Institution’s standard archiving procedures. Institution will retain such records Code for a minimum Proper Use of fifteen (15) years from the date of database closure. At least ninety (90) days prior to the expiry of such retention period, Sponsor will contact Institution. If requested by Sponsor, Institution shall retain the records for a longer period of time at Sponsor’s expense. The Site Parties shall notify Sponsor immediately (not later than 24 hours) of any serious adverse events in accordance with the Protocol and applicable law and guidelines, and will cooperate with Sponsor in connection with any reports or filings related to such serious adverse eventHuman Tissue 2011.

CLINICAL TRIAL GOVERNANCE AND COMPLIANCE. The Sponsor shall be responsible for obtaining and maintaining Clinical Trial Authorisation for the Clinical Trial and substantial amendments to the Protocol. The Sponsor may require the Principal Investigator to apply for the Clinical Trial Authorisation for Sponsor, in which case the Principal Investigator shall keep the Sponsor fully apprised of the progress of Ethics Committee submissions and shall upon request provide the Sponsor with all correspondence relating to such submissions. The Principal Investigator shall not consent to any change in the Protocol requested by the Ethics Committee or Competent Authority without the prior written consent of the Sponsor. In the event of any substantial amendments being made to the Protocol, the amendments shall be signed by the Principal Investigator and shall be implemented by the Research Staff as required by the Sponsor or CRO after approval of the amendments by the Competent Authority competent authority(ies) and a favourable opinion of the Ethics Committee. The Clinical Trial shall be performed at the Trial Site. The Principal Investigator shall be responsible for obtaining authorization from the representatives of the Trial Site to perform the Clinical Trial at the Trial Site, which shall include but not be limited to the engagement of sub-investigators, to the extent applicable the pharmacist of the Institution (unless a separate Pharmacy Agreement is made as set out in article 7.1 below)Institution, clinical chemists, and the Research Staff required to perform the Clinical Trial as set out in this Agreement. The Sponsor shall submit the Clinical Trial for listing on a free, publicly accessible clinical trial registry like xxx.xxxxxxxxxxxxxx.xxx or on websites managed by a registry conforming to WHO standards (xxxx://xxx.xxx.xxx/ictrp/network/criteria_summary/en/index.html) after Clinical Trial Authorization. Upon request of the Institution or the Principal Investigator the Sponsor will disclose the registry and the date of submission. The Principal Investigator hereby represents, warrants and covenants that he/she has obtained and shall maintain all necessary authorizations from the Trial Site representatives to perform the Clinical Trial. The Parties shall conduct the Clinical Trial in accordance with: the Agreement; the Protocol; the terms and conditions of the Clinical Trial Authorisation granted by the Competent Authority and the opinion of the Ethics Committee; and the applicable Law. The Site Parties shall make and retain records regarding the Clinical Trial as required by the Protocol, applicable Law, and in accordance with the Institution’s standard archiving procedures. Institution will retain such records for a minimum of fifteen (15) years from the date of database closure. At least ninety (90) days prior to the expiry of such retention period, Sponsor will contact Institution. If requested by Sponsor, Institution shall retain the records for a longer period of time at Sponsor’s expense. The Site Parties shall notify Sponsor immediately (not later than 24 hours) of any serious adverse events in accordance with the Protocol and applicable law and guidelines, and will cooperate with Sponsor in connection with any reports or filings related to such serious adverse event.

CLINICAL TRIAL GOVERNANCE AND COMPLIANCE. The Sponsor shall be responsible for obtaining and maintaining Clinical Trial Authorisation for the Clinical Trial and substantial amendments to the Protocol. The Sponsor may require the Principal Investigator to apply for the Clinical Trial Authorisation for Sponsor, in which case the Principal Investigator shall keep the Sponsor fully apprised of the progress of Ethics Committee submissions and shall upon request provide the Sponsor with all correspondence relating to such submissions. The Principal Investigator shall not consent to any change in the Protocol requested by the Ethics Committee or Competent Authority without the prior written consent of the Sponsor. In the event of any substantial amendments being made to the Protocol, the amendments shall be signed by the Principal Investigator and shall be implemented by the Research Staff as required by the Sponsor or CRO after approval of the amendments by the Competent Authority and a favourable opinion of the Ethics Committee. The Clinical Trial shall be performed at the Trial Site. The Principal Investigator shall be responsible for obtaining authorization from the representatives of the Trial Site to perform the Clinical Trial at the Trial Site, which shall include but not be limited to the engagement of sub-investigators, to the extent applicable the pharmacist of the Institution (unless a separate Pharmacy Agreement is made as set out in article 7.1 below), clinical chemists, and the Research Staff required to perform the Clinical Trial as set out in this Agreement. The Sponsor shall submit the Clinical Trial for listing on a free, publicly accessible clinical trial registry like xxx.xxxxxxxxxxxxxx.xxx or on websites managed by a registry conforming to WHO standards (xxxx://xxx.xxx.xxx/ictrp/network/criteria_summary/en/index.html) after Clinical Trial Authorization. Upon request of the Institution or the Principal Investigator the Sponsor will disclose the registry and the date of submission. The Parties shall conduct the Clinical Trial in accordance with: the Agreement; the Protocol; the terms and conditions of the Clinical Trial Authorisation granted by the Competent Authority and the opinion of the Ethics Committee; and the applicable Law. The Site Parties shall make and retain records regarding the Clinical Trial as required by the Protocol, applicable Law, and in accordance with the Institution’s standard archiving procedures. Institution will retain such records for a minimum of fifteen (15) years from time as put out in the date of database closureapplicable Law. At least ninety (90) days prior to the expiry of such retention period, Sponsor will contact Institution. If requested indicated by SponsorSponsor that such is reasonably required for regulatory purposes, Institution shall retain the records for a longer period of time at Sponsor’s expense. The Site Parties shall notify Sponsor immediately (not later than 24 hours) of any serious adverse events in accordance with the Protocol and applicable law and guidelinesLaw, and will cooperate with Sponsor in connection with any reports or filings related to such serious adverse event.