Common use of DUTIES OF CONTRACTING PARTIES Clause in Contracts

DUTIES OF CONTRACTING PARTIES. The contracting parties are bound to fully implement all clauses of this contract, according to its provisions of those of the PROTOCOL. Each party shall comply with its obligations, as per the normative indicated in the third Clause. For each party, obligations, duties and functions under RD/2004 are considered as bonding content in the current Agreement, so any violation will be considered as non-compliance of the current Agreement. Parties are committed to: Collaborating in the TRIAL follow-up visits conducted by: (i) CEIC, (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 agreed otherwise among the parties). Technical and organizational steps will be taken during these follow-up, monitoring and audit visits to ensure maximum compliance with norms to protect personal data. Comply with internal HOSPITAL and FOUNDATION regulations, on the part of the INVESTIGATOR, SPONSOR, monitors and auditors, as well compliance with the development guidelines for the TRIAL established by the CEIC responsible for its monitoring. Not issuing agreements or pacts related to the implementation of the TRIAL that might result in exceptions or contradictions with its content. Therefore, each Party states that, as of this date, none of them are part of any agreement or pact that might contradict its content. Specifically, by virtue of this Clause, the Parties shall accept that there will be no agreement to provide compensation of any kind to the PRINCIPAL INVESTIGATOR, or any of his/her collaborators other than those stated in this Agreement. Expenditures for meetings to organize and supervise the implementation of the TRIAL are excluded, as well as those to analyze or disseminate the results (scientific presentations or publications). In addition to the obligations stated in the applicable norms, the SPONSOR is bound to provide constant support to the PRINCIPAL INVESTIGATOR and to provide him/her and CEIC with any new relevant information related to the drug under research. The FOUNDATION is bound to the financial management of the present TRIAL. The FOUNDATION shall receive the payments from the SPONSOR, and will distribute them according to Annex I. The PRINCIPAL INVESTIGATOR agrees to safeguard the patient identification codes. The SPONSOR and PRINCIPAL INVESTIGATOR agree to maintain the essential documents of the TRIAL during the time period and according to the conditions set forth by current legislation. It is the PRINCIPAL INVESTIGATOR’S responsibility to select the members of the research team and the support staff for the TRIAL. They can either be individuals, trading entities, or organizations of a different nature, with adequate material and human resources for its implementation. FIFTH.- ECONOMIC ASPECTS The cost of this TRIAL has been initially budgeted at __________EUROS (______€) (TRIAL budget, from now on). This cost has been determined by applying a cost of _______ EUROS (____ €) per subject to be evaluated, as established by the Economic Memorandum of the TRIAL (Annex 1), which specifies all economic aspects. The sum to be provided by the SPONSOR during the implementation of the TRIAL will be set according to the specifications of Annex 1, and shall be paid to the FOUNDATION as detailed below: ____ % of the TRIAL budget to be paid upon signature of this contract. The remainder of the TRIAL budget shall be paid, at least each semester, as detailed in the table of cost per visit and recruited patient, included as Annex 1, until the total cost of the budget is paid off. The SPONSOR and the PRINCIPAL INVESTIGATOR will report to the FOUNDATION on a quarterly basis. These instalments will be considered as partial payments to the account, subject to the liquidation of final total expenses of the TRIAL. The final contribution of the SPONSOR for the implementation of the TRIAL shall be determined by actual activities implemented while conducting the TRIAL (Final cost, from now on). Final cost will be estimated as follows: Within a maximum period of three (3) months, from the completion of the TRIAL at the HOSPITAL, the SPONSOR and the PRINCIPAL INVESTIGATOR shall report in writing to the FOUNDATION the total number of (i) recruited and evaluated subjects, (ii) actual number of visits, (iii) resulting incidences, as well as any tests, analysis, examination, consultation, or hospital stay of special nature that might have occurred, whether or not included in the Economic Memorandum (Annex 1). As soon as the information mentioned below had been communicated, the FOUNDATION will calculate and notify to the parties the final cost of the TRIAL, as well as the remaining amounts to be paid by each of them, if applicable. This settlement of the Final Cost will determine the amounts owed by each party, which must be paid by who ever results to be creditors in the period of one (1) month with no need of subsequent requirement

DUTIES OF CONTRACTING PARTIES. The contracting parties are bound to fully implement all clauses of this contract, according to its provisions of those of the PROTOCOL. Each party shall comply with its obligations, as per the normative indicated in the third Clause. For each party, obligations, duties and functions under RD/2004 applicable regulations are considered as bonding content in the current Agreement, so any violation will be considered as non-compliance of the current Agreement. Parties are committed to: Collaborating in the TRIAL STUDY follow-up visits conducted by: (i) CEIC, (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 agreed otherwise among the parties). Technical and organizational steps will be taken during these follow-up, monitoring and audit visits to ensure maximum compliance with norms to protect personal data. Comply with internal HOSPITAL and FOUNDATION regulations, on the part of the INVESTIGATOR, SPONSOR, monitors and auditors, as well compliance with the development guidelines for the TRIAL STUDY established by the CEIC responsible for its monitoring. Not issuing agreements or pacts related to the implementation of the TRIAL STUDY that might result in exceptions or contradictions with its content. Therefore, each Party states that, as of this date, none of them are part of any agreement or pact that might contradict its content. Specifically, by virtue of this Clause, the Parties shall accept that there will be no agreement to provide compensation of any kind to the PRINCIPAL INVESTIGATOR, or any of his/her collaborators other than those stated in this Agreement. Expenditures for meetings to organize and supervise the implementation of the TRIAL STUDY are excluded, as well as those to analyze or disseminate the results (scientific presentations or publications). In addition to the obligations stated in the applicable norms, the SPONSOR is bound to provide constant support to the PRINCIPAL INVESTIGATOR and to provide him/her and CEIC with any new relevant information related to the drug under research. The FOUNDATION is bound to the financial management of the present TRIALSTUDY. The FOUNDATION shall receive the payments from the SPONSOR, and will distribute them according to Annex I. Xxxxx X. The PRINCIPAL INVESTIGATOR agrees to safeguard the patient identification codes. The SPONSOR and PRINCIPAL INVESTIGATOR agree to maintain the essential documents of the TRIAL STUDY during the time period and according to the conditions set forth by current legislation. It is the PRINCIPAL INVESTIGATOR’S responsibility to select the members of the research team and the support staff for the TRIALSTUDY. They can either be individuals, trading entities, or organizations of a different nature, with adequate material and human resources for its implementation. FIFTH.- ECONOMIC ASPECTS The cost of this TRIAL has been initially budgeted at __________EUROS (______€) (TRIAL budget, from now on). This cost has been determined by applying a cost of _______ EUROS (____ €) per subject to be evaluated, as established by the Economic Memorandum of the TRIAL (Annex 1), which specifies all economic aspects. The sum to be provided by the SPONSOR during the implementation of the TRIAL will be set according to the specifications of Annex 1, and shall be paid to the FOUNDATION as detailed below: ____ % of the TRIAL budget to be paid upon signature of this contract. The remainder of the TRIAL budget shall be paid, at least each semester, as detailed in the table of cost per visit and recruited patient, included as Annex 1, until the total cost of the budget is paid off. The SPONSOR and the PRINCIPAL INVESTIGATOR will report to the FOUNDATION on a quarterly basis. These instalments will be considered as partial payments to the account, subject to the liquidation of final total expenses of the TRIAL. The final contribution of the SPONSOR for the implementation of the TRIAL shall be determined by actual activities implemented while conducting the TRIAL (Final cost, from now on). Final cost will be estimated as follows: Within a maximum period of three (3) months, from the completion of the TRIAL at the HOSPITAL, the SPONSOR and the PRINCIPAL INVESTIGATOR shall report in writing to the FOUNDATION the total number of (i) recruited and evaluated subjects, (ii) actual number of visits, (iii) resulting incidences, as well as any tests, analysis, examination, consultation, or hospital stay of special nature that might have occurred, whether or not included in the Economic Memorandum (Annex 1). As soon as the information mentioned below had been communicated, the FOUNDATION will calculate and notify to the parties the final cost of the TRIAL, as well as the remaining amounts to be paid by each of them, if applicable. This settlement of the Final Cost will determine the amounts owed by each party, which must be paid by who ever results to be creditors in the period of one (1) month with no need of subsequent requirement.

DUTIES OF CONTRACTING PARTIES. The contracting parties are bound to fully implement all clauses of this contract, according to its provisions of those of the PROTOCOL. Each party shall comply with its obligations, as per the normative indicated in the third Clause. For each party, obligations, duties and functions under RD/2004 are considered as bonding content in the current Agreement, so any violation will be considered as non-compliance of the current Agreement. Parties are committed to: Collaborating in the TRIAL follow-up visits conducted by: (i) CEIC, (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 agreed otherwise among the parties). Technical and organizational steps will be taken during these follow-up, monitoring and audit visits to ensure maximum compliance with norms to protect personal data. Comply with internal HOSPITAL and FOUNDATION regulations, on the part of the INVESTIGATOR, SPONSOR, monitors and auditors, as well compliance with the development guidelines for the TRIAL established by the CEIC responsible for its monitoring. Not issuing agreements or pacts related to the implementation of the TRIAL that might result in exceptions or contradictions with its content. Therefore, each Party states that, as of this date, none of them are part of any agreement or pact that might contradict its content. Specifically, by virtue of this Clause, the Parties shall accept that there will be no agreement to provide compensation of any kind to the PRINCIPAL INVESTIGATOR, or any of his/her collaborators other than those stated in this Agreement. Expenditures for meetings to organize and supervise the implementation of the TRIAL are excluded, as well as those to analyze or disseminate the results (scientific presentations or publications). In addition to the obligations stated in the applicable norms, the SPONSOR is bound to provide constant support to the PRINCIPAL INVESTIGATOR and to provide him/her and CEIC with any new relevant information related to the drug under research. The FOUNDATION is bound to the financial management of the present TRIAL. The FOUNDATION shall receive the payments from the SPONSOR, and will distribute them according to Annex I. Xxxxx X. The PRINCIPAL INVESTIGATOR agrees to safeguard the patient identification codes. The SPONSOR and PRINCIPAL INVESTIGATOR agree to maintain the essential documents of the TRIAL during the time period and according to the conditions set forth by current legislation. It is the PRINCIPAL INVESTIGATOR’S responsibility to select the members of the research team and the support staff for the TRIAL. They can either be individuals, trading entities, or organizations of a different nature, with adequate material and human resources for its implementation. FIFTH.- ECONOMIC ASPECTS The cost of this TRIAL has been initially budgeted at __________EUROS (______€) (TRIAL budget, from now on). This cost has been determined by applying a cost of _______ EUROS (____ €) per subject to be evaluated, as established by the Economic Memorandum of the TRIAL (Annex 1), which specifies all economic aspects. The sum to be provided by the SPONSOR during the implementation of the TRIAL will be set according to the specifications of Annex 1, and shall be paid to the FOUNDATION as detailed below: ____ % of The SPONSOR and the TRIAL budget to be paid upon signature of this contract. The remainder of PRINCIPAL INVESTIGATOR shall inform the TRIAL budget shall be paidFOUNDATION, at least each semester, as detailed in of the table number of cost per visit patients included and recruited patient, included as visits performed according to what is stated on Annex 1, and base on such information, the FOUNDATION will issue the corresponding invoices until the total cost payment of the amount that forms the budget is paid off. The SPONSOR and the PRINCIPAL INVESTIGATOR will report to the FOUNDATION on a quarterly basisof this trial. These instalments will be considered as partial payments to the account, subject to the liquidation of final total expenses of the TRIAL. The final contribution of the SPONSOR for the implementation of the TRIAL shall be determined by actual activities implemented while conducting the TRIAL (Final cost, from now on). Final cost will be estimated as follows: Within a maximum period of three (3) months, from the completion of the TRIAL at the HOSPITAL, the SPONSOR and the PRINCIPAL INVESTIGATOR shall report in writing to the FOUNDATION the total number of (i) recruited and evaluated subjects, (ii) actual number of visits, (iii) resulting incidences, as well as any tests, analysis, examination, consultation, or hospital stay of special nature that might have occurred, whether or not included in the Economic Memorandum (Annex 1). As soon as the information mentioned below had been communicated, the FOUNDATION will calculate and notify to the parties the final cost of the TRIAL, as well as the remaining amounts to be paid by each of them, if applicable. This settlement of the Final Cost will determine the amounts owed by each party, which must be paid by who ever results to be creditors in the period of one (1) month with no need of subsequent requirement.

DUTIES OF CONTRACTING PARTIES. The contracting parties are bound to fully implement all clauses of this contract, according to its provisions of those of the PROTOCOL. Each party shall comply with its obligations, as per the normative indicated in the third Clause. For each party, obligations, duties and functions under RD/2004 applicable regulations are considered as bonding content in the current Agreement, so any violation will be considered as non-compliance of the current Agreement. Parties are committed to: Collaborating in the TRIAL STUDY follow-up visits conducted by: (i) CEIC, (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 agreed otherwise among the parties). Technical and organizational steps will be taken during these follow-up, monitoring and audit visits to ensure maximum compliance with norms to protect personal data. Comply with internal HOSPITAL and FOUNDATION regulations, on the part of the INVESTIGATOR, SPONSOR, monitors and auditors, as well compliance with the development guidelines for the TRIAL STUDY established by the CEIC responsible for its monitoring. Not issuing agreements or pacts related to the implementation of the TRIAL STUDY that might result in exceptions or contradictions with its content. Therefore, each Party states that, as of this date, none of them are part of any agreement or pact that might contradict its content. Specifically, by virtue of this Clause, the Parties shall accept that there will be no agreement to provide compensation of any kind to the PRINCIPAL INVESTIGATOR, or any of his/her collaborators other than those stated in this Agreement. Expenditures for meetings to organize and supervise the implementation of the TRIAL STUDY are excluded, as well as those to analyze or disseminate the results (scientific presentations or publications). In addition to the obligations stated in the applicable norms, the SPONSOR is bound to provide constant support to the PRINCIPAL INVESTIGATOR and to provide him/her and CEIC with any new relevant information related to the drug under research. The FOUNDATION is bound to the financial management of the present TRIALSTUDY. The FOUNDATION shall receive the payments from the SPONSOR, and will distribute them according to Annex I. The PRINCIPAL INVESTIGATOR agrees to safeguard the patient identification codes. The SPONSOR and PRINCIPAL INVESTIGATOR agree to maintain the essential documents of the TRIAL STUDY during the time period and according to the conditions set forth by current legislation. It is the PRINCIPAL INVESTIGATOR’S responsibility to select the members of the research team and the support staff for the TRIALSTUDY. They can either be individuals, trading entities, or organizations of a different nature, with adequate material and human resources for its implementation. FIFTH.- ECONOMIC ASPECTS The cost of this TRIAL has been initially budgeted at __________EUROS (______€) (TRIAL budget, from now on). This cost has been determined by applying a cost of _______ EUROS (____ €) per subject to be evaluated, as established by the Economic Memorandum of the TRIAL (Annex 1), which specifies all economic aspects. The sum to be provided by the SPONSOR during the implementation of the TRIAL will be set according to the specifications of Annex 1, and shall be paid to the FOUNDATION as detailed below: ____ % of the TRIAL budget to be paid upon signature of this contract. The remainder of the TRIAL budget shall be paid, at least each semester, as detailed in the table of cost per visit and recruited patient, included as Annex 1, until the total cost of the budget is paid off. The SPONSOR and the PRINCIPAL INVESTIGATOR will report to the FOUNDATION on a quarterly basis. These instalments will be considered as partial payments to the account, subject to the liquidation of final total expenses of the TRIAL. The final contribution of the SPONSOR for the implementation of the TRIAL shall be determined by actual activities implemented while conducting the TRIAL (Final cost, from now on). Final cost will be estimated as follows: Within a maximum period of three (3) months, from the completion of the TRIAL at the HOSPITAL, the SPONSOR and the PRINCIPAL INVESTIGATOR shall report in writing to the FOUNDATION the total number of (i) recruited and evaluated subjects, (ii) actual number of visits, (iii) resulting incidences, as well as any tests, analysis, examination, consultation, or hospital stay of special nature that might have occurred, whether or not included in the Economic Memorandum (Annex 1). As soon as the information mentioned below had been communicated, the FOUNDATION will calculate and notify to the parties the final cost of the TRIAL, as well as the remaining amounts to be paid by each of them, if applicable. This settlement of the Final Cost will determine the amounts owed by each party, which must be paid by who ever results to be creditors in the period of one (1) month with no need of subsequent requirement.