Common use of Investigator and Institution Clause in Contracts

Investigator and Institution. shall ensure the prompt, complete, and accurate collection, recording and classification of the Medical Records, Study Results and of all clinical supplies, equipment and Study Drug provided by SPONSOR or CRO or its Affiliates and shall store such materials according to the Protocol or Study Instructions. Institution and Investigator shall: (i) maintain and store Medical Records including the list of Subject’s identification codes and Study Results in a secure manner with physical and electronic access restrictions, as applicable and environmental controls appropriate to the applicable data type and in accordance with Applicable Laws, regulations and industry standards; and (ii) protect the Medical Records and Study Results from unauthorized use, access, duplication, and disclosure. If directed by Sponsor by means of CRO or CRO, Institution and Investigator will submit Study Results using the electronic system provided by Sponsor by means of CRO or CRO or their designated representative and in accordance with Sponsor’s instructions for electronic data entry. Institution and Investigator shall prevent unauthorized access to the Study Results by maintaining physical security of the electronic system and ensuring that Study Personnel maintain the confidentiality of their passwords. Investigator agrees to collect all Study Results in Medical Records prior to entering it into the eCRF/CRF. Institution and Investigator shall ensure the prompt submission of eCRFs/CRFs; and (iii) take measures to prevent accidental or premature destruction or damage of these documents, for as long as agreed herewith. 2.10 a) The Medical Records and Study Data shall be retained for a minimum of twenty five (25) years from the Institution´s close out visit or for the duration required by Applicable Law, whichever is longer. In compliance with Sponsor’s obligations under ICH GCP, Sponsor shall notify the Institution in writing if the Medical Records and Study Data are no longer needed before the completion of the minimum retention period agreed herewith. If the Institution has not been notified by Sponsor otherwise before the completion of the minimum retention period, then after the completion of the minimum retention period the Institution can destroy or permit the destruction of the Medical Records and Study Data. Any inquiries or requests regarding record retention can be sent at any time during the retention period to the email address xxxxxxx@xxxxxxxxxx.xxx, but in no circumstance shall Institution be allowed to destroy or permit the destruction of the Medical Records and Study Data before the minimum retention period unless Institution receives express written instruction from Sponsor in this regard. 2.10 b) If the Investigator leaves the Institution, then responsibility for maintaining Medical Records and Study Results shall be determined in accordance with applicable regulations but Institution will not in any case be relieved of its obligations under this Agreement for maintaining the Medical Records and Study Results. 2.10 c) Institution shall retain ownership of Medical Records. The Institution and the Investigator hereby assign to Sponsor all of their rights, title and interest, including intellectual property rights, to all Confidential Information (as defined below). For the avoidance of doubt, the Study Results and Study Data shall be and remain the sole and exclusive property of the Sponsor or of such party as the Sponsor may designate, as the case may be. Institution shall collect, retain, analyze and use such Samples solely according to the Protocol and in a manner consistent with the informed consent forms. At the completion or termination of the Study, or sooner at the request of the CRO (or Sponsor by means of CRO), Institution and Investigator shall, as instructed by Sponsor (by means of CRO), either return all Samples to the Sponsor or destroy the Samples in accordance with Sponsor’s instructions and Applicable Laws and regulations.

Investigator and Institution. shall ensure the prompt, complete, and accurate collection, recording and classification of the Medical Records, Study Results and of all clinical supplies, equipment and Study Drug provided by SPONSOR or CRO or its Affiliates and shall store such materials according to the Protocol or Study InstructionsInstructions and in accordance with Applicable Law. Institution and Investigator shall: (i) maintain and store Medical Records including the list of Subject’s identification codes and Study Results in a secure manner with physical and electronic access restrictions, as applicable and environmental controls appropriate to the applicable data type and in accordance with Applicable Laws, regulations and industry standards; and (ii) protect the Medical Records and Study Results from unauthorized use, access, duplication, and disclosure. If directed by Sponsor by means of CRO or CRO, Institution and Investigator will submit Study Results using the electronic system provided by Sponsor by means of CRO or CRO or their designated representative and in accordance with Sponsor’s instructions for electronic data entry. Institution and Investigator shall prevent unauthorized access to the Study Results by maintaining physical security of the electronic system and ensuring that Study Personnel maintain the confidentiality of their passwords. Investigator agrees to collect all Study Results in Medical Records prior to entering it into the eCRF/CRF. Institution and Investigator shall ensure the prompt submission of eCRFs/CRFs; and (iii) take measures to prevent accidental or premature destruction or damage of these documents, for as long as agreed herewith. 2.10 a) The Medical Records and Study Data shall be retained for a minimum of twenty five (25) years from the Institution´s close out visit or for the duration required by Applicable Law, whichever is longer. In compliance with Sponsor’s obligations under ICH GCP, Sponsor shall notify the Institution in writing if the Medical Records and Study Data are no longer needed before the completion of the minimum retention period agreed herewith. Institution shall ensure archiving for free for the period of 5 years, in accordance with the Act no. 378/2007 Coll., and paid archiving for further 20 years for the fee of . An invoice shall be issued for paid archiving after the execution of this Agreement. If the Institution has not been notified by Sponsor otherwise before the completion insists on extension of the minimum retention archiving period, then after it shall notify Institution in advance, no later than 6 months prior the completion expiry of the minimum retention archiving period and shall pay the associated costs. In the event that within the aforementioned period Sponsor does not notify Institution can of its request to extend the archiving period or does not pay the fee for extended archiving, Institution is entitled to destroy or permit all the destruction archived documents of the Medical Records Study. In case Institution will be closed or no longer available for record retention for any reason, Institution must notify Sponsor in writing at least sixty (60) days in advance and perform any instruction to transfer the Study DataData as provided by Sponsor. Any inquiries or requests regarding record retention can be sent at any time during the retention period to the email address xxxxxxx@xxxxxxxxxx.xxx, but in no circumstance shall Institution be allowed to destroy or permit the destruction of the Medical Records and Study Data before the minimum retention period period, as it is stated above, unless Institution receives express written instruction from Sponsor in this regard. 2.10 b) If the Investigator leaves the ends his employment relationship with Institution, then responsibility for maintaining Medical Records and Study Results shall be determined in accordance with applicable regulations but Institution will not in any case be relieved of its obligations under this Agreement for maintaining the Medical Records and Study Results. 2.10 c) Institution shall retain ownership of Medical Records. It is understood that Study Subject’s Medical files kept in the Institution in the normal course of business irrespective of the Study are not the property of Sponsor, but shall be made available to CRO and Sponsor for review to the extent and in accordance with the law of the Czech Republic and in accordance with the Subject´s informed consent. The Institution and the Investigator hereby assign to Sponsor all of their rights, title and interest, including intellectual property rights, to all Confidential Information (as defined below). For the avoidance of doubt, the Study Results and Study Data shall be and remain the sole and exclusive property of the Sponsor or of such party as the Sponsor may designate, as the case may be. Subject to Applicable local Laws and regulations Sponsor shall be the sole owner of any biological samples ("Samples"). Institution shall collect, retain, analyze and use such Samples solely according to the Protocol and in a manner consistent with the informed consent forms. At the completion or termination of the Study, or sooner at the request of the CRO (or Sponsor by means of CRO)Sponsor, Institution and Investigator shall, as instructed by Sponsor (by means of CRO)Sponsor, either return all Samples to the Sponsor or destroy the Samples in accordance with Sponsor’s 's instructions and Applicable Laws and regulations.

Investigator and Institution. shall ensure the prompt, complete, and accurate collection, recording and classification of the Medical Records, Study Results and of all clinical supplies, equipment and Study Drug provided by SPONSOR or CRO or its Affiliates and shall store such materials according to the Protocol or Study Instructions. Institution and Investigator shallshall : (i) maintain and store Medical Records including the list of Subject’s identification codes and Study Results in a secure manner with physical and electronic access restrictions, as applicable and environmental controls appropriate to the applicable data type and in accordance with Applicable Laws, regulations and industry standards; and (ii) protect the Medical Records and Study Results from unauthorized use, access, duplication, and disclosure. If directed by Sponsor by means of CRO or CRO, Institution and Investigator will submit Study Results using the electronic system provided by Sponsor by means of CRO or CRO or their designated representative and in accordance with Sponsor’s instructions for electronic data entry. Institution and Investigator shall prevent unauthorized access to the Study Results by maintaining physical security of the electronic system and ensuring that Study Personnel maintain the confidentiality of their passwords. Investigator agrees to collect all Study Results in Medical Records prior to entering it into the eCRF/CRF. Institution and Investigator shall ensure the prompt submission of eCRFs/CRFs; and (iii) take measures to prevent accidental or premature destruction or damage of these documents, for as long as agreed herewith. 2.10 a) The Medical Records and Study Data shall be retained for a minimum of twenty five (25) years from the Institution´s close out visit or for the duration required by Applicable Law, whichever is longer. In compliance with Sponsor’s obligations under ICH GCP, Sponsor shall notify the Institution in writing if the Medical Records and Study Data are no longer needed before the completion of the minimum retention period agreed herewith. If the In case Institution has not been notified by will be closed or no longer available for record retention for any reason, Institution must notify Sponsor otherwise before the completion of the minimum retention period, then after the completion of the minimum retention period the Institution can destroy or permit the destruction of in writing at least sixty (60) days in advance and perform any instruction to transfer the Medical Records and Study DataData as provided by Sponsor. Any inquiries or requests regarding record retention can be sent at any time during the retention period to the email address xxxxxxx@xxxxxxxxxx.xxx, but in no circumstance shall Institution be allowed to destroy or permit the destruction of the Medical Records and Study Data before the minimum retention period unless Institution receives express written instruction from Sponsor in this regard. 2.10 b) If the Investigator leaves the Institution, then responsibility for maintaining Medical Records and Study Results shall be determined in accordance with applicable regulations but Institution will not in any case be relieved of its obligations under this Agreement for maintaining the Medical Records and Study Results. 2.10 c) Institution shall retain ownership of Medical Records. The Institution and the Investigator hereby assign to Sponsor all of their rights, title and interest, including intellectual property rights, to all Confidential Information (as defined below). For the avoidance of doubt, the Study Results and Study Data shall be and remain the sole and exclusive property of the Sponsor or of such party as the Sponsor may designate, as the case may be. Subject to Applicable local Laws and regulations Sponsor shall be the sole owner of any biological samples ("Samples"). Institution shall collect, retain, analyze and use such Samples solely according to the Protocol and in a manner consistent with the informed consent forms. At the completion or termination of the Study, or sooner at the request of the CRO (or Sponsor by means of CRO)Sponsor, Institution and Investigator shall, as instructed by Sponsor (by means of CRO)Sponsor, either return all Samples to the Sponsor or destroy the Samples in accordance with Sponsor’s 's instructions and Applicable Laws and regulations.

Investigator and Institution. shall ensure the prompt, complete, and accurate collection, recording and classification of the Medical Records, Study Results and of all clinical supplies, equipment and Study Drug provided by SPONSOR or CRO or its Affiliates and shall store such materials according to the Protocol or Study InstructionsInstructions and in accordance with Applicable Law. Institution and Investigator shall: (i) maintain and store Medical Records including the list of Subject’s identification codes and Study Results in a secure manner with physical and electronic access restrictions, as applicable and environmental controls appropriate to the applicable data type and in accordance with Applicable Laws, regulations and industry standards; and (ii) protect the Medical Records and Study Results from unauthorized use, access, duplication, and disclosure. If directed by Sponsor by means of CRO or CRO, Institution and Investigator will submit Study Results using the electronic system provided by Sponsor by means of CRO or CRO or their designated representative and in accordance with Sponsor’s instructions for electronic data entry. Institution and Investigator shall prevent unauthorized access to the Study Results by maintaining physical security of the electronic system and ensuring that Study Personnel maintain the confidentiality of their passwords. Investigator agrees to collect all Study Results in Medical Records prior to entering it into the eCRF/CRF. Institution and Investigator shall ensure the prompt submission of eCRFs/CRFs; and (iii) take measures to prevent accidental or premature destruction or damage of these documents, for as long as agreed herewith. 2.10 a) The Medical Records and Study Data shall be retained for a minimum of twenty five (25) years from the Institution´s close out visit or for the duration required by Applicable Law, whichever is longer. In compliance with Sponsor’s obligations under ICH GCP, Sponsor shall notify the Institution in writing if the Medical Records and Study Data are no longer needed before the completion of the minimum retention period agreed herewith. Institution shall ensure archiving for free for the period of 5 years, in accordance with the Act no. 378/2007 Coll., and paid archiving for further 20 years for the fee of . An invoice shall be issued for paid archiving after the execution of this Agreement. If the Institution has not been notified by Sponsor otherwise before the completion insists on extension of the minimum retention archiving period, then after it shall notify Institution in advance, no later than 6 months prior the completion expiry of the minimum retention archiving period and shall pay the associated costs. In the event that within the aforementioned period Sponsor does not notify Institution can of its request to extend the archiving period or does not pay the fee for extended archiving, Institution is entitled to destroy or permit all the destruction archived documents of the Medical Records Study. In case Institution will be closed or no longer available for record retention for any reason, Institution must notify Sponsor in writing at least sixty (60) days in advance and perform any instruction to transfer the Study DataData as provided by Sponsor. Any inquiries or requests regarding record retention can be sent at any time during the retention period to the email address xxxxxxx@xxxxxxxxxx.xxx, but in no circumstance shall Institution be allowed to destroy or permit the destruction of the Medical Records and Study Data before the minimum retention period period, as it is stated above, unless Institution receives express written instruction from Sponsor in this regard. 2.10 b) If the Investigator leaves the Institutionends his employment relationship withInstitution, then responsibility for maintaining Medical Records and Study Results shall be determined in accordance with applicable regulations but Institution will not in any case be relieved of its obligations under this Agreement for maintaining the Medical Records and Study Results. 2.10 c) Institution shall retain ownership of Medical Records. It is understood that Study Subject’s Medical files kept in the Institution in the normal course of business irrespective of the Study are not the property of Sponsor, but shall be made available to CRO and Sponsor for review to the extent and in accordance with the law of the Czech Republic and in accordance with the Subject´s informed consent. The Institution and the Investigator hereby assign to Sponsor all of their rights, title and interest, including intellectual property rights, to all Confidential Information (as defined below). For the avoidance of doubt, the Study Results and Study Data shall be and remain the sole and exclusive property of the Sponsor or of such party as the Sponsor may designate, as the case may be. Subject to Applicable local Laws and regulations Sponsor shall be the sole owner of any biological samples ("Samples"). Institution shall collect, retain, analyze and use such Samples solely according to the Protocol and in a manner consistent with the informed consent forms. At the completion or termination of the Study, or sooner at the request of the CRO (or Sponsor by means of CRO)Sponsor, Institution and Investigator shall, as instructed by Sponsor (by means of CRO)Sponsor, either return all Samples to the Sponsor or destroy the Samples in accordance with Sponsor’s 's instructions and Applicable Laws and regulations.

Investigator and Institution. shall ensure the prompt, complete, and accurate collection, recording and classification of the Medical Records, Study Results and of all clinical supplies, equipment and Study Drug provided by SPONSOR or CRO or its Affiliates and shall store such materials according to the Protocol or Study Instructions. Institution and Investigator shallshall : (i) maintain and store Medical Records including the list of Subject’s identification codes and Study Results in a secure manner with physical and electronic access restrictions, as applicable and environmental controls appropriate to the applicable data type and in accordance with Applicable Laws, regulations and industry standards; and (ii) protect the Medical Records and Study Results from unauthorized use, access, duplication, and disclosure. If directed by Sponsor by means of CRO or CRO, Institution and Investigator will submit Study Results using the electronic system provided by Sponsor by means of CRO or CRO or their designated representative and in accordance with Sponsor’s instructions for electronic data entry. Institution and Investigator shall prevent unauthorized access to the Study Results by maintaining physical security of the electronic system and ensuring that Study Personnel maintain the confidentiality of their passwords. Investigator agrees to collect all Study Results in Medical Records prior to entering it into the eCRF/CRF. Institution and Investigator shall ensure the prompt submission of eCRFs/CRFs; and (iii) take measures to prevent accidental or premature destruction or damage of these documents, for as long as agreed herewith. 2.10 a. duly sealed, to a third party appointed by Sponsor at Sponsor’s expense. If Institution does not receive a response from Sponsor after sixty (60) The days from the date the email was sent, Institution is allowed to destroy the Medical Records and Study Data shall be retained for a minimum of twenty five (25) years from the Institution´s close out visit or for the duration required by Applicable Law, whichever is longerData. In compliance with Sponsor’s obligations under ICH GCPcase Institution will be closed or no longer available for record retention for any reason, Institution must notify Sponsor shall notify the Institution in writing if at least sixty (60) days in advance and perform any instruction to transfer the Medical Records and Study Data are no longer needed before the completion of the minimum retention period agreed herewith. If the Institution has not been notified as provided by Sponsor otherwise before the completion of the minimum retention period, then after the completion of the minimum retention period the Institution can destroy or permit the destruction of the Medical Records and Study DataSponsor. Any inquiries or requests regarding record retention can be sent at any time during the retention period to the email address xxxxxxx@xxxxxxxxxx.xxx, but in no circumstance shall Institution be allowed to destroy or permit the destruction of the Medical Records and Study Data before the minimum retention period unless Institution receives express written instruction from Sponsor in this regard. 2.10 b) If the Investigator leaves the Institution, then responsibility for maintaining Medical Records and Study Results shall be determined in accordance with applicable regulations but Institution will not in any case be relieved of its obligations under this Agreement for maintaining the Medical Records and Study Results. 2.10 c) Institution shall retain ownership of Medical Records. The Institution and the Investigator hereby assign to Sponsor all of their rights, title and interest, including intellectual property rights, to all Confidential Information (as defined below). For the avoidance of doubt, the Study Results and Study Data shall be and remain the sole and exclusive property of the Sponsor or of such party as the Sponsor may designate, as the case may be. Institution shall collect, retain, analyze and use such Samples solely according to the Protocol and in a manner consistent with the informed consent forms. At the completion or termination of the Study, or sooner at the request of the CRO (or Sponsor by means of CRO), Institution and Investigator shall, as instructed by Sponsor (by means of CRO), either return all Samples to the Sponsor or destroy the Samples in accordance with Sponsor’s instructions and Applicable Laws and regulations.