Common use of CLINICAL TRIAL SUBJECT RECRUITMENT AND ENROLLMENT Clause in Contracts

CLINICAL TRIAL SUBJECT RECRUITMENT AND ENROLLMENT. The Principal Investigator shall make sure that the Clinical Trial Subjects (and/or their legal representatives) will, in accordance with applicable Law, be duly informed and that each give his informed consent prior to his participation in the Clinical Trial. Institution will provide Sponsor/CRO an opportunity to review and approve the content of any Clinical Trial recruitment materials (including the ICF) directed to potential Clinical Trial Subjects before such materials are used, regardless of medium. The Principal Investigator shall use reasonable endeavours to recruit the Target within the Timelines as specified in Annex 2. As soon as the Principal Investigator expects to reach the Target, he shall notify the Sponsor and/or CRO. If circumstances or events have occurred or will occur that will substantially delay or are likely to substantially delay the progress of recruitment or enrolment of the Clinical Trial Subjects, the Principal Investigator shall immediately inform the Sponsor and/or CRO in writing. In each such event the Parties shall discuss the consequences of the delay and each Party shall undertake reasonable endeavours to agree on measures to overcome the delay. In the event that the Clinical Trial is part of a multi-centre clinical trial, the Sponsor may amend the number of Clinical Trial Subjects to be recruited pursuant to the Target as per clause 5.2 above subject to this clause 5.4. The Sponsor may require further recruitment of Clinical Trial Subjects at the Trial Site to cease if: in the reasonable opinion of the Sponsor recruitment of Clinical Trial Subjects at the Trial Site will not meet or will not likely meet the Target within the Timelines or is proceeding at a rate below that required to enable the relevant Timeline to be met, and upon Sponsor’s request to increase the inclusion rate, the Principal Investigator is unable to comply, or if the global recruitment target for all clinical centres of Sponsor and its affiliates has been reached. Upon receipt of a notice subject to clause 5.4 (a), the Principal Investigator shall immediately stop the recruitment and inclusion of Clinical Trial Subjects. The terms and conditions of this Agreement regarding the Clinical Trial Subjects shall also apply to individuals who, at the time of receipt of such notice, have signed the ICF. Payments shall only be made according to the number of Clinical Trial Subjects recruited and included up to the date of receipt of the notice. The Sponsor will not take any responsibility or have a duty to make any payment for the Clinical Trial Subjects recruited after the date of receipt of its notice. If recruitment of Clinical Trial Subjects is proceeding at a rate above that required to meet the relevant Timelines the Sponsor may with the agreement of the Principal Investigator increase the number and amend the rate of Clinical Trial Subjects to be recruited and enrolled at the Trial Site.

CLINICAL TRIAL SUBJECT RECRUITMENT AND ENROLLMENT. The Principal Investigator Institution shall make sure that the Clinical Trial Subjects (and/or their legal representatives) will, in accordance with applicable Law, be duly informed and that each give his informed consent prior to his participation in the Clinical Trial. Institution will provide shall submit for approval to Sponsor/CRO an opportunity to review and approve the content of any Clinical Trial recruitment materials (including the ICF) directed to potential Clinical Trial Subjects before such materials are used, regardless of medium. The Institution, through its Principal Investigator Investigator, shall use reasonable endeavours to recruit the Target within the Timelines as specified in Annex 2. As soon as the Principal Investigator expects to reach the Target, he shall notify the Sponsor and/or CRO. If circumstances or events have occurred or will occur that will substantially delay or are likely to substantially delay the progress of recruitment or enrolment of the Clinical Trial Subjects, the Principal Investigator shall immediately without undue delay inform the Sponsor and/or CRO in writing. In each such event the Parties shall discuss the consequences of the delay and each Party shall undertake reasonable endeavours to agree on measures to overcome address the delay. In the event that the Clinical Trial is part of a multi-centre clinical trial, the Sponsor may amend the number of Clinical Trial Subjects to be recruited pursuant to the Target as per clause 5.2 above subject to this clause 5.4. The Sponsor may require further recruitment of Clinical Trial Subjects at the Trial Site to cease if: in the reasonable opinion of the Sponsor recruitment of Clinical Trial Subjects at the Trial Site will not meet or will not likely meet the Target within the Timelines or is proceeding at a rate below that required to enable the relevant Timeline to be met, and upon Sponsor’s request to increase the inclusion rate, the Principal Investigator is unable to comply, or if the global recruitment target for all clinical centres of Sponsor and its affiliates has been reached. Upon receipt of a notice subject to clause 5.4 (a)5.4.a, the Principal Investigator shall immediately stop the recruitment and inclusion of Clinical Trial Subjects. The terms and conditions of this Agreement regarding the Clinical Trial Subjects shall also apply to individuals who, at the time of receipt of such notice, have signed the ICF. Payments shall only be made according to the number of Clinical Trial Subjects recruited and included up to the date of receipt of the notice. The Sponsor will not take any responsibility or have a duty to make any payment for the Clinical Trial Subjects recruited after the date of receipt of its notice. If recruitment of Clinical Trial Subjects is proceeding at a rate above that required to meet the relevant Timelines the Sponsor may with the agreement of the Principal Investigator increase the number and amend the rate of Clinical Trial Subjects to be recruited and enrolled at the Trial Site.

CLINICAL TRIAL SUBJECT RECRUITMENT AND ENROLLMENT. The Principal Investigator shall make sure that the Clinical Trial Subjects (and/or their legal representatives) will, in accordance with applicable Law, be duly informed and that each give his informed consent prior to his participation in the Clinical Trial. Institution will provide Sponsor/CRO an opportunity to review and approve the content of any Clinical Trial recruitment materials (including the ICF) directed to potential Clinical Trial Subjects before such materials are used, regardless of medium. The Principal Investigator shall use reasonable endeavours to recruit the Target within the Timelines as specified in Annex 2. As soon as the Principal Investigator expects to reach the Target, he shall notify the Sponsor and/or CRO. If circumstances or events have occurred or will occur that will substantially delay or are likely to substantially delay the progress of recruitment or enrolment of the Clinical Trial Subjects, the Principal Investigator shall immediately inform the Sponsor and/or CRO in writing. In each such event the Parties shall discuss the consequences of the delay and each Party shall undertake reasonable endeavours to agree on measures to overcome the delay. In the event that the Clinical Trial is part of a multi-centre clinical trial, the Sponsor may amend the number of Clinical Trial Subjects to be recruited pursuant to the Target as per clause 5.2 above subject to this clause 5.4. The Sponsor may require further recruitment of Clinical Trial Subjects at the Trial Site to cease if: in the reasonable opinion of the Sponsor recruitment of Clinical Trial Subjects at the Trial Site will not meet or will not likely meet the Target within the Timelines or is proceeding at a rate below that required to enable the relevant Timeline to be met, and upon Sponsor’s request to increase the inclusion rate, the Principal Investigator is unable to comply, or if the global recruitment target for all clinical centres of Sponsor and its affiliates has been reached. Upon receipt of a notice subject to clause 5.4 (a)5.4.a, the Principal Investigator shall immediately stop the recruitment and inclusion of Clinical Trial Subjects. The terms and conditions of this Agreement regarding the Clinical Trial Subjects shall also apply to individuals who, at the time of receipt of such notice, have signed the ICF. Payments shall only be made according to the number of Clinical Trial Subjects recruited and included up to the date of receipt of the notice. The Sponsor will not take any responsibility or have a duty to make any payment for the Clinical Trial Subjects recruited after the date of receipt of its notice. If recruitment of Clinical Trial Subjects is proceeding at a rate above that required to meet the relevant Timelines the Sponsor may with the agreement of the Principal Investigator increase the number and amend the rate of Clinical Trial Subjects to be recruited and enrolled at the Trial Site.

CLINICAL TRIAL SUBJECT RECRUITMENT AND ENROLLMENT. The Principal Investigator shall make sure that the Clinical Trial Subjects (and/or their legal representatives) will, in accordance with applicable Law, be duly informed and that each give his informed consent prior to his participation in the Clinical Trial. Institution will provide Sponsor/CRO an opportunity to review and approve the content of any Clinical Trial recruitment materials (including the ICF) directed to potential Clinical Trial Subjects before such materials are used, regardless of medium. The Principal Investigator shall use reasonable endeavours to recruit the Target within the Timelines as specified in Annex 2. As soon as the Principal Investigator expects to reach the Target, he shall notify the Sponsor. Likewise, in case the Principal Investigator expects that the Target will not be reached within the given Timelines, he shall notify Sponsor and/or CROaccordingly, and the Parties shall discuss the consequences. If circumstances or events have occurred or will occur that will substantially delay or are likely to substantially delay the progress of recruitment or enrolment of the Clinical Trial Subjects, the Principal Investigator shall immediately inform the Sponsor and/or CRO in writing. In each such event the Parties shall discuss the consequences of the delay and each Party shall undertake reasonable endeavours to agree on measures to overcome the delay. In the event that the Clinical Trial is part of a multi-centre clinical trial, the Sponsor may amend the number of Clinical Trial Subjects to be recruited pursuant to the Target as per clause 5.2 above subject to this clause 5.4. The Sponsor may require further recruitment of Clinical Trial Subjects at the Trial Site to cease if: in the reasonable opinion of the Sponsor recruitment of Clinical Trial Subjects at the Trial Site will not meet or will not likely meet the Target within the Timelines or is proceeding at a rate below that required to enable the relevant Timeline to be met, and upon Sponsor’s request to increase the inclusion rate, the Principal Investigator is unable to comply, or if the global recruitment target for all clinical centres of Sponsor and its affiliates has been reached. Upon receipt of a notice subject to clause 5.4 (a), the Principal Investigator shall immediately stop the recruitment and inclusion of Clinical Trial Subjects. The Subjects and the terms and conditions of this Agreement regarding the Clinical Trial Subjects shall also not apply to individuals who, at the time of receipt of such notice, have not signed informed consent and have not been included in the ICFClinical Trial. Payments shall only be made according to the number of Clinical Trial Subjects recruited and included up to the date of receipt of the notice. The Sponsor will not take any responsibility or have a duty to make any payment for the Clinical Trial Subjects recruited after the date of receipt of its notice. If recruitment of Clinical Trial Subjects is proceeding at a rate above that required to meet the relevant Timelines the Sponsor may with the agreement of the Principal Investigator increase the number and amend the rate of Clinical Trial Subjects to be recruited and enrolled at the Trial Site.;

CLINICAL TRIAL SUBJECT RECRUITMENT AND ENROLLMENT. The Principal Investigator Institution shall make sure or cause the Principal Investigator to make sure that in accordance with applicable legislation and the ICH GCP, the Clinical Trial Subjects (and/or and, if required by law, their legal representatives) will, in accordance with applicable Law, be duly informed and that each give his informed consent prior to his the Clinical Trial Subjects’ participation in the Clinical Trial. Institution Trial (a) will provide Sponsor/CRO an opportunity to review and approve be duly informed, in a language the content of any Clinical Trial recruitment materials (including the ICF) directed to potential Clinical Trial Subjects before such materials and their legal representatives can fully understand, on all aspects of the Clinical Trial which are usedrequired or deemed relevant in their decision to participate, regardless of mediumand (b) each give their informed consent. The Institution shall use reasonable endeavours to recruit or cause the Principal Investigator shall to use reasonable endeavours to recruit the Target within number of Clinical Trial Subjects in accordance with the Timelines Timelines, all as specified in Annex Exhibit 1. Furthermore, Sponsor may (1) advise a Rate of Clinical Trial Subjects by a designated time period (day, week or month), and/or (2) determine one or more Thresholds either up to or beyond the Target, each (1) and (2) to allow for and ensure the close monitoring of the progress of the Clinical Trial, the proper collection and recording of trial data, the welfare of the Clinical Trial Subjects, and altogether the good quality of the Clinical Trial and compliance with ICH GCP and applicable laws and regulations. The recruitment and inclusion of Clinical Trial Subjects by the Principal Investigator above and beyond the Target or Threshold(s), or any adjustment of the Target or Threshold(s), shall be subject to prior written approval of Sponsor. As soon as the Principal Investigator expects to reach the Targeta Target or Threshold, he he/she shall notify the Sponsor and/or CROSponsor. If circumstances or events have occurred or will occur that will substantially delay or that are likely to substantially delay the progress of recruitment or enrolment of the Clinical Trial Subjects, the Principal Investigator Institution shall immediately without any undue delay inform the Sponsor and/or CRO in writing. In each such event the Parties shall discuss the consequences of the delay and each Party shall undertake reasonable endeavours to agree on measures to overcome the delay or to agree such other arrangements that the Parties and the Principal Investigator consider appropriate for the further implementation of the Clinical Trial. If Institution has received from Sponsor all Investigational Product, means, information and Clinical Trial Authorisation necessary to perform the Clinical Trial and it has not recruited any Clinical Trial Subject within a reasonable period of time as mutually agreed by Parties in the Protocol or in other written documents, Sponsor is entitled to exclude the Trial Site from the Clinical Trial. Upon Sponsor’s decision to exclude the Trial Site, it shall notify Institution without delay. In the event that the Clinical Trial is part of a multi-centre clinical trial, trial (which for the purposes of this Agreement shall mean that at least one other institution is taking part) Sponsor may amend the number of Clinical Trial Subjects to be recruited pursuant to the Target as per clause 5.2 above subject to this clause 5.4. The Sponsor may require further recruitment the following, and always based on timely and adequate exchange of Clinical Trial Subjects at the Trial Site to cease ifinformation: If in the reasonable opinion of the Sponsor recruitment of Clinical Trial Subjects at the Trial Site Institution will not meet or will not likely meet the Target within the Timelines or is proceeding at a rate below that required to enable the relevant Timeline to be met, and upon Sponsor’s Sponsor may request Institution to increase the inclusion rate, number and rate of Clinical Trial Subjects to be recruited and enrolled at the Principal Investigator Trial Site. If Institution is unable to complydo so, Sponsor may (i) by notice to Institution require recruitment at the Trial Site to cease, or if (ii) with the global recruitment target for all clinical centres agreement of Sponsor and its affiliates has been reached. Upon receipt of a notice subject to clause 5.4 (a), the Principal Investigator shall immediately stop the recruitment and inclusion of Clinical Trial Subjects. The terms and conditions of this Agreement regarding the Clinical Trial Subjects shall also apply to individuals who, at the time of receipt of such notice, have signed the ICF. Payments shall only be made according to Institution decrease the number of Clinical Trial Subjects to be recruited and included up at Institution subject to the date of receipt of the notice. The Sponsor will not take any responsibility or have a duty to make any payment for the Clinical Trial Subjects recruited after the date of receipt of its notice. Authorization; or If recruitment of Clinical Trial Subjects is proceeding at a rate above that required to meet the relevant Timelines the Timelines, Sponsor may may, with the agreement of the Principal Investigator Institution, increase the number and amend the rate of Clinical Trial Subjects to be recruited and enrolled at the Trial Site; or If the overall recruitment target for all clinical centers that are part of the multi-centre clinical trial of Sponsor and its Affiliates has been reached, Sponsor may by notice to Institution require recruitment at the Trial Site to cease. The Principal Investigator shall upon receipt of a notice to cease the recruitment immediately stop further recruitment and inclusion of Clinical Trial Subjects and the terms of the Agreement shall relate thereafter to the number of Clinical Trial Subjects who have been enrolled in the Clinical Trial at the date of such notice. Payments shall only be made according to the number of Clinical Trial Subjects recruited up to the date of receipt of the notice and include non-cancellable expenses reasonably and necessarily incurred by or on behalf of Institution to perform its duties under this Agreement. Sponsor acknowledges that Institution’s cancellation of anticipated inclusions of Clinical Trial Subjects should be avoided as much as possible. Sponsor will have no duty to make any payment for Clinical Trial Subjects recruited after the date of receipt of its notice.

CLINICAL TRIAL SUBJECT RECRUITMENT AND ENROLLMENT. The Principal Investigator Institution shall make sure that the Clinical Trial Subjects (and/or their legal representatives) will, in accordance with applicable Law, be duly informed and that each give his informed consent prior to his participation in the Clinical Trial. Institution will provide shall submit for approval to Sponsor/CRO an opportunity to review and approve the content of any Clinical Trial recruitment materials (including the ICF) directed to potential Clinical Trial Subjects before such materials are used, regardless of medium. The Institution, through its Principal Investigator Investigator, shall use reasonable endeavours to recruit the Target within the Timelines as specified in Annex 2. As soon as the Principal Investigator expects to reach the Target, he shall notify the Sponsor and/or CRO. If circumstances or events have occurred or will occur that will substantially delay or are likely to substantially delay the progress of recruitment or enrolment of the Clinical Trial Subjects, the Principal Investigator shall immediately without undue delay inform the Sponsor and/or CRO in writing. In each such event the Parties shall discuss the consequences of the delay and each Party shall undertake reasonable endeavours to agree on measures to overcome address the delay. In the event that the Clinical Trial is part of a multi-centre clinical trial, the Sponsor may amend the number of Clinical Trial Subjects to be recruited pursuant to the Target as per clause 5.2 5.2. above subject to this clause 5.4. .. The Sponsor may require further recruitment of Clinical Trial Subjects at the Trial Site to cease if: in the reasonable opinion of the Sponsor recruitment of Clinical Trial Subjects at the Trial Site will not meet or will not likely meet the Target within the Timelines or is proceeding at a rate below that required to enable the relevant Timeline to be met, and upon Sponsor’s request to increase the inclusion rate, the Principal Investigator is unable to comply, or if the global recruitment target for all clinical centres of Sponsor and its affiliates has been reached. Upon receipt of a notice subject to clause 5.4 (a)a., the Principal Investigator shall immediately stop the recruitment and inclusion of Clinical Trial Subjects. The terms and conditions of this Agreement regarding the Clinical Trial Subjects shall also apply to individuals who, at the time of receipt of such notice, have signed the ICF. Payments shall only be made according to the number of Clinical Trial Subjects recruited and included up to the date of receipt of the notice. The Sponsor will not take any responsibility or have a duty to make any payment for the Clinical Trial Subjects recruited after the date of receipt of its notice. If recruitment of Clinical Trial Subjects is proceeding at a rate above that required to meet the relevant Timelines the Sponsor may with the agreement of the Principal Investigator increase the number and amend the rate of Clinical Trial Subjects to be recruited and enrolled at the Trial Site.