Common use of Duties of the Parties Clause in Contracts

Duties of the Parties. The contracting parties are bound to fully implement all clauses of this Agreement in its own terms, as well as those of the PROTOCOL. Each party shall comply with their respective obligations as per the legislation indicated in Clause THREE. Each party’s obligations, duties and functions under RD 1090/2015 are deemed binding content of the present Agreement, and consequently any violation thereof shall be considered as non-compliance of the Agreement. The Parties are committed also to: Collaborating in the CLINICAL TRIAL follow-up visits conducted by: (i) the CREC, (ii) the monitors and auditors acting on behalf of the SPONSOR, and (iii) the competent authorities when conducting inspection interventions. There shall be at least a one week notice prior to these visits (unless the Parties agree otherwise). Technical and organizational steps will be taken during these follow-up, monitoring and audit visits to ensure full compliance with any applicable personal data protection statute. The PRINCIPAL INVESTIGATOR, the SPONSOR, the monitors and the auditors shall comply with both the HOSPITAL and the FOUNDATION internal rules as shall be notified by them, and with the instructions from the monitoring CREC about the execution of the CLINICAL TRIAL. Not entering into any agreements or commitments related to the implementation of the CLINICAL TRIAL that might result in exceptions or contradictions with its content. Therefore, each Party states that, at this date, none of them is a party in any agreement or pact that might contradict its content. In particular, by virtue of this Clause, the Parties agree that they shall in no event compromise or pay any compensation whatsoever other than those provided for in the Agreement, without prejudice to the expenses incurred for the attendance to/celebration of the meetings required to organize and supervise the execution of the STUDY and the meetings designed to analyze or make the STUDY’s results public (presentations or scientific publications). In addition to the obligations stated in the applicable norms, the SPONSOR shall provide constant support to the PRINCIPAL INVESTIGATOR and shall provide him/her and the CREC with any new information related to the drug under research that may be relevant. It is the FOUNDATION’s responsibility to manage the financial aspect of this CLINICAL TRIAL. To such affect, the FOUNDATION shall receive any payments made by the SPONSOR/CRO and shall distribute them according to the provisions of Schedule 1. The PRINCIPAL INVESTIGATOR agrees to safeguard the patient identification codes. The SPONSOR and the PRINCIPAL INVESTIGATOR agree to maintain the essential documents of the CLINICAL TRIAL during the period and according to the conditions set forth by the laws curently in force. It is the PRINCIPAL INVESTIGATOR’S responsibility also to select the members of the research team and the support staff for the CLINICAL TRIAL. These can be either natural or legal persons, or organizations of a different nature, in any case with adequate material and human resources for its implementation. Attached as Schedule 2 is a comprehensive list of the current members of the research team at the date of execution of this Agreement. Any change in the list of members of the research team shall be notified to the CREC as per the laws in force.

Duties of the Parties. The contracting parties are bound to fully implement all clauses of this Agreement in its own terms, as well as those of the PROTOCOL. Each party shall comply with their respective obligations as per the legislation indicated in Clause CLAUSE THREE. Each party’s obligations, duties and functions under RD 1090/2015 are deemed binding content of the present Agreement, and consequently any violation thereof shall be considered as non-compliance of the Agreement. The Parties are committed also to: Collaborating in the CLINICAL TRIAL follow-up visits conducted by: (i) the CREC, (ii) the monitors and auditors acting on behalf of the SPONSOR, and (iii) the competent authorities when conducting inspection interventions. There shall be at least a one one-week notice prior to these visits (unless the Parties agree otherwise). Technical and organizational organisational steps will be taken during these follow-up, monitoring and audit visits to ensure full compliance with any applicable personal data protection statute. ; The PRINCIPAL INVESTIGATOR, the SPONSOR, the monitors and the auditors shall comply with both the HOSPITAL and the FOUNDATION internal rules as shall be notified by them, and with the instructions from the monitoring CREC about the execution of the CLINICAL TRIAL. ; Not entering into any agreements or commitments related to the implementation of the CLINICAL TRIAL that might result in exceptions or contradictions with its content. Therefore, each Party states that, at this date, none of them is a party in any agreement or pact that might contradict its content. In particular, by virtue of this Clause, the Parties agree that they shall in no event compromise or pay any compensation whatsoever other than those provided for in the Agreement, without prejudice to the expenses incurred for the attendance to/celebration of the meetings required to organize and supervise the execution of the STUDY and the meetings designed to analyze analyse or make the STUDY’s results public (presentations or scientific publications). In addition to the obligations stated in the applicable norms, the SPONSOR shall provide constant support to the PRINCIPAL INVESTIGATOR and shall provide him/her and the CREC with any new information related to the drug under research that may be mightbe relevant. It is the FOUNDATION’s responsibility to manage the financial aspect of this CLINICAL TRIAL. To such affecteffect, the FOUNDATION shall receive any payments made by the SPONSOR/CRO and shall distribute them according to the provisions of Schedule SCHEDULE 1. The PRINCIPAL INVESTIGATOR agrees to safeguard the patient identification codes. The SPONSOR and the PRINCIPAL INVESTIGATOR agree to maintain the essential documents of the CLINICAL TRIAL during the period and according to the conditions set forth by the laws curently currently in force. It is also the PRINCIPAL INVESTIGATOR’S responsibility also to select the members of the research team and the support staff for the CLINICAL TRIAL. These can be either natural or legal persons, or organizations organisations of a different naturenature;in any case, in any case with adequate material and human resources for its implementation. Attached as Schedule APPENDIX 2 is a comprehensive list of the current members of the research team at the date of execution of this Agreement. Any change in the list of members of the research team shall be notified to reportedto the CREC as per the laws in force.

Duties of the Parties. The contracting parties are bound to fully implement all clauses of this Agreement in its own terms, as well as those of the PROTOCOL. Each party shall comply with their respective obligations as per the legislation indicated in Clause THREE. Each party’s obligations, duties duties, and functions under RD 1090/2015 are deemed binding content of the present Agreement, Agreement and consequently any violation thereof shall be considered as non-compliance of the Agreement. The Parties are also committed also to: Collaborating Collaborate in the CLINICAL TRIAL follow-up visits conducted by: (i1) the CRECCEIm, (ii2) the monitors and auditors acting on behalf of the SPONSOR, and (iii3) the competent authorities when conducting inspection interventions. There shall be at least a one week notice prior to these visits (visits, unless the Parties agree otherwise). Technical and organizational steps will be taken during these follow-up, monitoring monitoring, and audit visits to ensure full compliance with any applicable personal data protection statute. The PRINCIPAL INVESTIGATOR, the SPONSOR, the monitors monitors, and the auditors shall comply with both the standards and internal regulations of the HOSPITAL and the FOUNDATION internal rules as shall FOUNDATION, of which will be notified provided by themthe entities, and with the in addition to instructions from the monitoring CREC about the execution on implementation of the CLINICAL TRIALTRIAL prepared by the CEIm responsible for monitoring it. Not entering into any agreements or commitments related to the implementation of the CLINICAL TRIAL that might result in exceptions or contradictions with its content. Therefore, each Party states that, that at this date, none of them is a party in any agreement or pact that might contradict its contentthis agreement. In particular, by virtue of this Clause, the Parties agree that they shall in no event compromise or pay any compensation whatsoever other than those provided for in the Agreement, without prejudice to the expenses incurred for the attendance to/celebration of the meetings required to organize and supervise the execution of the STUDY and the meetings designed to analyze or make the STUDY’s results public (presentations or scientific publications). In addition to the obligations stated in the applicable normsregulations, the SPONSOR shall provide constant support to the PRINCIPAL INVESTIGATOR and shall provide him/her and the CREC CEIm with any new information related to the drug under research that may be relevant. It is the FOUNDATION’s responsibility of the FOUNDATION to manage the financial aspect of this CLINICAL TRIAL. To such affect, the FOUNDATION shall receive any payments made by the SPONSOR/CRO and shall distribute them according to the provisions of Schedule Annex 1. The PRINCIPAL INVESTIGATOR agrees to safeguard the patient identification codes. The SPONSOR and the PRINCIPAL INVESTIGATOR agree to maintain the essential documents of the CLINICAL TRIAL during the period and according to the conditions set forth by the laws curently currently in force. It is also the responsibility of the PRINCIPAL INVESTIGATOR’S responsibility also INVESTIGATOR to select the members of the research team and the support staff for the CLINICAL TRIAL. These can be either natural or legal persons, or organizations TRIAL that must consist of a different nature, in any case with adequate material and human resources for its implementationimplementation of such. Attached as Schedule Annex 2 is a comprehensive list of the current members of the research team at the date of execution of this AgreementAgreement was executed. Any change in the list of members of the research team shall be notified to the CREC CEIm as per the laws in force.

Duties of the Parties. The contracting parties are bound to fully implement all clauses of this Agreement in its own terms, as well as those of the PROTOCOL. Each party shall comply with their respective obligations as per the legislation indicated in Clause CLAUSE THREE. Each party’s obligations, duties duties, and functions under RD 1090/2015 applicable laws are deemed binding content of the present Agreement, and consequently any violation thereof shall be considered as non-compliance of the Agreement. The Parties are committed also to: Collaborating in the CLINICAL TRIAL follow-up visits conducted by: (i) the CREC, (ii) the monitors and auditors acting on behalf of the SPONSOR, and (iii) the competent authorities when conducting inspection interventions. There shall be at least a one one-week notice prior to these visits (unless the Parties agree otherwise). Technical and organizational organisational steps will be taken during these follow-up, monitoring monitoring, and audit visits to ensure full compliance with any applicable personal data protection statute. ; The PRINCIPAL INVESTIGATOR, the SPONSOR, the monitors monitors, and the auditors shall comply with both the HOSPITAL and the FOUNDATION internal rules as shall andshall be notified by them, and with the instructions from the monitoring CREC about the execution of the CLINICAL TRIAL. ; Not entering into any agreements or commitments related to the implementation of the CLINICAL TRIAL that might result in exceptions or contradictions with its content. Therefore, each Party states that, at this date, none of them is a party in any agreement or pact that might contradict its content. In particular, by virtue of this Clause, the Parties agree that they shall in no event compromise or pay any compensation whatsoever other than those provided for in the Agreement, without prejudice to the expenses incurred for the attendance to/celebration of the meetings required to organize organise and supervise the execution of the STUDY and the meetings designed to analyze analyse or make the STUDY’s results public (presentations or scientific publications). In addition to the obligations stated in the applicable norms, the SPONSOR shall provide constant support to the PRINCIPAL INVESTIGATOR and shall provide him/her and the CREC with any new information related to the drug under research that may be mightbe relevant. It is the FOUNDATION’s responsibility to manage the financial aspect of this CLINICAL TRIAL. To such affecteffect, the FOUNDATION shall receive any payments made by the SPONSOR/CRO and shall distribute them according to the provisions of Schedule SCHEDULE 1. The PRINCIPAL INVESTIGATOR agrees to safeguard the patient identification codes. The SPONSOR and the PRINCIPAL INVESTIGATOR agree to maintain the essential documents of the CLINICAL TRIAL during the period and according to the conditions set forth by the laws curently currently in force. It is the PRINCIPAL INVESTIGATOR’S responsibility also to select the members of the research team and the support staff for the CLINICAL TRIAL. These can be either natural or legal persons, or organizations organisations of a different naturenature;in any case, in any case with adequate material and human resources for its implementation. Attached as Schedule SCHEDULE 2 is a comprehensive list of the current members of the research team at the date of execution of this Agreement. Any change in the list of members of the research team shall be notified to reportedto the CREC as per the laws in force.

Duties of the Parties. The contracting parties are bound to fully implement all clauses of this Agreement in its own terms, as well as those of the PROTOCOL. Each party shall comply with their respective obligations as per the legislation indicated in Clause CLAUSE THREE. Each party’s obligations, duties and functions under RD 1090/2015 are deemed binding content of the present Agreement, and consequently any violation thereof shall be considered as non-compliance of the Agreement. The Parties are committed also to: Collaborating in the CLINICAL TRIAL follow-up visits conducted by: (i) the CREC, (ii) the monitors and auditors acting on behalf of the SPONSOR, and (iii) the competent authorities when conducting inspection interventions. There shall be at least a one one-week notice prior to these visits (unless the Parties agree otherwise). Technical and organizational organisational steps will be taken during these follow-up, monitoring monitoring, and audit visits to ensure full compliance with any applicable personal data protection statute. The PRINCIPAL INVESTIGATOR, the SPONSOR, the monitors and the auditors shall comply with both the HOSPITAL and the FOUNDATION internal rules as shall andshall be notified by them, and with the instructions from the monitoring CREC about the execution of the CLINICAL TRIAL. Not entering into any agreements or commitments related to the implementation of the CLINICAL TRIAL that might result in exceptions or contradictions with its content. Therefore, each Party states that, at this date, none of them is a party in any agreement or pact that might contradict its content. In particular, by virtue of this Clause, the Parties agree that they shall in no event compromise or pay any compensation whatsoever other than those provided for in the Agreement, without prejudice to the expenses incurred for the attendance to/celebration of the meetings required to organize organise and supervise the execution of the STUDY and the meetings designed to analyze analyse or make the STUDY’s results public (presentations or scientific publications). In addition to the obligations stated in the applicable norms, the SPONSOR shall provide constant support to the PRINCIPAL INVESTIGATOR and shall provide him/her and the CREC with any new information related to the drug under research that may be relevant. It is the FOUNDATION’s responsibility to manage the financial aspect of this CLINICAL TRIAL. To such affecteffect, the FOUNDATION shall receive any payments made by the SPONSOR/CRO and shall distribute them according to the provisions of Schedule SCHEDULE 1. The PRINCIPAL INVESTIGATOR agrees to safeguard the patient identification codes. The SPONSOR and the PRINCIPAL INVESTIGATOR agree to maintain the essential documents of the CLINICAL TRIAL during the period and according to the conditions set forth by the laws curently currently in force. It is the PRINCIPAL INVESTIGATOR’S responsibility also to select the members of the research team and the support staff for the CLINICAL TRIAL. These can be either natural or legal persons, or organizations organisations of a different naturenature;in any case, in any case with adequate material and human resources for its implementation. Attached as Schedule SCHEDULE 2 is a comprehensive list of the current members of the research team at the date of execution of this Agreement. Any change in the list of members of the research team shall be notified to reportedto the CREC as per the laws in force.