Common use of Subject of the agreement Clause in Contracts

Subject of the agreement. 2.1 The Sponsor/CRO hereby entrusts the Entity with the execution of the Trial under the terms of this Agreement, in accordance with the Protocol and any subsequent amendments, and with the amendments to this Agreement/budget resulting from such amendments formalised by the necessary deeds of amendment, duly signed. 2.2 The Trial is to be conducted in strict compliance with the Protocol, in the version in force as accepted by the Principal Investigator and approved by the Ethics Committee and the Competent Authority in conformity with the principles of ethics and medical practice followed by the healthcare staff involved in the Trial in any capacity and according to the applicable laws, in particular: (a) In the case of clinical drugs trial Or (b) In the case of clinical trial on medical device Or (c) In the case of observational studies on drugs 2.3 The Trial shall also be conducted in accordance with the principles of the Convention on Human Rights and Biomedicine, the updated version of the Helsinki Declaration, the current rules of good clinical practice, and in accordance with the applicable laws on transparency, anti-corruption and the current data protection regulations. 2.4 By signing this Agreement, the Parties declare that they know and accept the contents of the above rules and regulations. 2.5 The Sponsor and the Principal Investigator have an obligation to protect patients’ safety and, where required in the circumstances, may take urgent, appropriate measures to protect patients’ safety such as temporarily suspending the Study (interruption of treatment for patients already enrolled or interruption of the enrolment of new patients), even without the necessary approval of the Ethics Committee and the Competent Authority, subject to the Sponsor's obligation to inform the Ethics Committee and the Competent Authority immediately of any new events, the measures taken, and the programme of measures to be taken in the future, and will duly complete the procedures required by the applicable laws. (a) In the case of non-competitive inclusion of patients or (b) In the case of a multi-centre competitive-enrolment trial 2.7 The Entity and the Sponsor will keep the Trial documentation (the “Trial Master File”) for the period of time specified in the applicable laws, that is to say twety-five years according to the provisions of EU Regulation 536/2014, with respect to the conclusion of the Trial at the Entity, as required by the Protocol (cf. Art. 7). The Sponsor is obligated to inform the Entity of the expiry of the mandatory conservation period (only if requested). At the request of the Sponsor, after expiry of the mandatory conservation period, the Parties may agree the terms of a further conservation period after the expiry of the aforementioned term. 2.8 The Entity and the Sponsor, each within their own sphere of responsibility, shall also use forms of digitalisation (or dematerialisation) to conserve the documentation. Regardless of whether or not the archived Trial documentation contains personal data (of a special nature or otherwise), according to the definitions in Regulation (EU) No. 679/2016, the Entity and the Sponsor shall take all the physical and technical measures referred to in Article 32 of said Regulation (EU) No. 679/2016 and shall carry out any security checks as required by current legislation to protect the data, information and documents (both printed and digital). The archiving system shall guarantee not only the integrity of the data, information and printed/digital documents but also their future legibility throughout the mandatory conservation period. To fulfil such obligation both the Sponsor and the Entity may rely on external service providers to manage the archiving obligation. 2.9 The Sponsor, the Entity and the Principal Investigator shall comply with the directions, indications, instructions and recommendations given by the Ethics Committee and by the Competent Authority.

Subject of the agreement. 2.1 The Sponsor/CRO hereby entrusts the Entity with the execution of the Trial under the terms of this Agreement, in accordance with the Protocol and any subsequent amendments, and with the amendments to this Agreement/budget resulting from such amendments formalised by the necessary deeds of amendment, duly signed. 2.2 The Trial is to be conducted in strict compliance with the Protocol, in the version in force as accepted by the Principal Investigator and approved by the Ethics Committee and the Competent Authority in conformity with the principles of ethics and medical practice followed by the healthcare staff involved in the Trial in any capacity and according to the applicable laws, in particular: (a) In the case of clinical drugs trial Or (b) In the case of clinical trial on medical device Or (c) In the case of observational studies on drugs 2.3 The Trial shall also be conducted in accordance with the principles of the Convention on Human Rights and Biomedicine, the updated version of the Helsinki Declaration, the current rules of good clinical practice, and in accordance with the applicable laws on transparency, anti-corruption and the current data protection regulations. 2.4 By signing this Agreement, the Parties declare that they know and accept the contents of the above rules and regulations. 2.5 The Sponsor and the Principal Investigator have an obligation to protect patients’ safety and, where required in the circumstances, may take urgent, appropriate measures to protect patients’ safety such as temporarily suspending the Study (interruption of treatment for patients already enrolled or interruption of the enrolment of new patients), even without the necessary approval of the Ethics Committee and the Competent Authority, subject to the Sponsor's obligation to inform the Ethics Committee and the Competent Authority immediately of any new events, the measures taken, and the programme of measures to be taken in the future, and will duly complete the procedures required by the applicable laws. (a) In the case of non-competitive inclusion of patients or (b) In the case of a multi-centre competitive-enrolment trial 2.7 The Entity and the Sponsor will keep the Trial documentation (the “Trial Master File”) for the period of time specified in the applicable laws, that is to say twety-five years according to the provisions of EU Regulation 536/2014, laws with respect to the conclusion of the Trial at the Entity, as required by the Protocol (cf. Art. 7). The Sponsor is obligated to inform the Entity of the expiry of the mandatory conservation period (only if requested). At the request of the Sponsor, after expiry of the mandatory conservation period, the Parties may agree the terms of a further conservation period after the expiry of the aforementioned term. 2.8 The Entity and the Sponsor, each within their own sphere of responsibility, shall also use forms of digitalisation (or dematerialisation) to conserve the documentation. Regardless of whether or not the archived Trial documentation contains personal data (of a special nature or otherwise), according to the definitions in Regulation (EU) No. 679/2016, the Entity and the Sponsor shall take all the physical and technical measures referred to in Article 32 of said Regulation (EU) No. 679/2016 and shall carry out any security checks as required by current legislation to protect the data, information and documents (both printed and digital). The archiving system shall guarantee not only the integrity of the data, information and printed/digital documents but also their future legibility throughout the mandatory conservation period. To fulfil such obligation both the Sponsor and the Entity may rely on external service providers to manage the archiving obligation. 2.9 The Sponsor, the Entity and the Principal Investigator shall comply with the directions, indications, instructions and recommendations given by the Ethics Committee and by the Competent Authority.

Subject of the agreement. 2.1 The Sponsor/CRO hereby entrusts the Entity with the execution of the Trial under the terms of this Agreement, in accordance with the Protocol and any subsequent amendments, and with the amendments to this Agreement/budget resulting from such amendments formalised by the necessary deeds of amendment, duly signed. 2.2 The Trial is to be conducted in strict compliance with the Protocol, in the version in force as accepted by the Principal Investigator and approved by the Ethics Committee and the Competent Authority in conformity with the principles of ethics and medical practice followed by the healthcare staff involved in the Trial in any capacity and according to the applicable laws, in particular: (a) In the case of clinical drugs trial Or (b) In the case of clinical trial on medical device Or (c) In the case of observational studies on drugs 2.3 The Trial shall also be conducted in accordance with the principles of the Convention on Human Rights and Biomedicine, the updated version of the Helsinki Declaration, the current rules of good clinical practice, and in accordance with the applicable laws on transparency, anti-corruption and the current data protection regulations. 2.4 By signing this Agreement, the Parties declare that they know and accept the contents of the above rules and regulations. 2.5 The Sponsor and the Principal Investigator have an obligation to protect patients’ safety and, where required in the circumstances, may take urgent, appropriate measures to protect patients’ safety such as temporarily suspending the Study (interruption of treatment for patients already enrolled or interruption of the enrolment of new patients), even without the necessary approval of the Ethics Committee and the Competent Authority, subject to the Sponsor's obligation to inform the Ethics Committee and the Competent Authority immediately of any new events, the measures taken, and the programme of measures to be taken in the future, and will duly complete the procedures required by the applicable laws. (a) In the case of non-competitive inclusion of patients orOr (b) In the case of a multi-centre competitive-enrolment trial 2.7 The Entity and the Sponsor will keep the Trial documentation (the “Trial Master File”) for the period of time specified in the applicable laws, that is to say twety-five years according to the provisions of EU Regulation 536/2014, with respect to the conclusion of the Trial at the Entity, as required by the Protocol (cf. Art. 7). The Sponsor is obligated to inform the Entity of the expiry of the mandatory conservation period (only if requested). At the request of the Sponsor, after expiry of the mandatory conservation period, the Parties may agree the terms of a further conservation period after the expiry of the aforementioned term. 2.8 The Entity and the Sponsor, each within their own sphere of responsibility, shall also use forms of digitalisation (or dematerialisation) to conserve the documentation. Regardless of whether or not the archived Trial documentation contains personal data (of a special nature or otherwise), according to the definitions in Regulation (EU) No. 679/2016, the Entity and the Sponsor shall take all the physical and technical measures referred to in Article 32 of said Regulation (EU) No. 679/2016 and shall carry out any security checks as required by current legislation to protect the data, information and documents (both printed and digital). The archiving system shall guarantee not only the integrity of the data, information and printed/digital documents but also their future legibility throughout the mandatory conservation period. To fulfil such obligation both the Sponsor and the Entity may rely on external service providers to manage the archiving obligation. 2.9 The Sponsor, the Entity and the Principal Investigator shall comply with the directions, indications, instructions and recommendations given by the Ethics Committee and by the Competent Authority.

Subject of the agreement. 2.1 The Sponsor/CRO hereby entrusts the Entity with the execution of the Trial under the terms of this Agreement, in accordance with the Protocol and any subsequent amendments, and with the amendments to this Agreement/budget resulting from such amendments formalised by the necessary deeds of amendment, duly signed. 2.2 The Trial is to be conducted in strict compliance with the Protocol, in the version in force as accepted by the Principal Investigator and approved by the Ethics Committee and the Competent Authority in conformity with the principles of ethics and medical practice followed by the healthcare staff involved in the Trial in any capacity and according to the applicable laws, in particular: (a) In the case of clinical drugs trial Or (b) In the case of clinical trial on medical device Or (c) In the case of observational studies on drugs 2.3 The Trial shall also be conducted in accordance with the principles of the Convention on Human Rights and Biomedicine, the updated version of the Helsinki Declaration, the current rules of good clinical practice, and in accordance with the applicable laws on transparency, anti-corruption and the current data protection regulations. 2.4 By signing this Agreement, the Parties declare that they know and accept the contents of the above rules and regulations. 2.5 The Sponsor and the Principal Investigator have an obligation to protect patients’ safety and, where required in the circumstances, may take urgent, appropriate measures to protect patients’ safety such as temporarily suspending the Study (interruption of treatment for patients already enrolled or interruption of the enrolment of new patients), even without the necessary approval of the Ethics Committee and the Competent Authority, subject to the Sponsor's obligation to inform the Ethics Committee and the Competent Authority immediately of any new events, the measures taken, and the programme of measures to be taken in the future, and will duly complete the procedures required by the applicable laws. (a) In the case of non-competitive inclusion of patients orOr (b) In the case of a multi-centre competitive-enrolment trial 2.7 The Entity and the Sponsor will keep the Trial documentation (the “Trial Master File”) for the period of time specified in the applicable laws, that is to say twety-five years according to the provisions of EU Regulation 536/2014, laws with respect to the conclusion of the Trial at the Entity, as required by the Protocol (cf. Art. 7). The Sponsor is obligated to inform the Entity of the expiry of the mandatory conservation period (only if requested). At the request of the Sponsor, after expiry of the mandatory conservation period, the Parties may agree the terms of a further conservation period after the expiry of the aforementioned term. 2.8 The Entity and the Sponsor, each within their own sphere of responsibility, shall also use forms of digitalisation (or dematerialisation) to conserve the documentation. Regardless of whether or not the archived Trial documentation contains personal data (of a special nature or otherwise), according to the definitions in Regulation (EU) No. 679/2016, the Entity and the Sponsor shall take all the physical and technical measures referred to in Article 32 of said Regulation (EU) No. 679/2016 and shall carry out any security checks as required by current legislation to protect the data, information and documents (both printed and digital). The archiving system shall guarantee not only the integrity of the data, information and printed/digital documents but also their future legibility throughout the mandatory conservation period. To fulfil such obligation both the Sponsor and the Entity may rely on external service providers to manage the archiving obligation. 2.9 The Sponsor, the Entity and the Principal Investigator shall comply with the directions, indications, instructions and recommendations given by the Ethics Committee and by the Competent Authority.