Common use of Study Site Clause in Contracts

Study Site. The Study should be conducted at ________________. The Site will provide the human resources included in its normal activity in the execution of the Study. Biobizkaia will invoice the Sponsor for all costs incurred in the Study, except for the compensation to the investigation team (if there is no express indication by the Principal Investigator). The financial arrangements will be detailed in the Payment Schedule attached as Annex II of this Agreement, as an inseparable part of it. It will include, thus: Costs for managing the Agreement The amount of ________________ + VAT (Table I of Annex II) is established to be paid for management of the Agreement and the payment will be made on presentation of the corresponding invoice at the same time that the Agreement is ready for signatures. In multicentre studies a single payment will be made for this item. The total amounts to be paid will be calculated according to the table published by ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇. Costs of running the Study. (Invoice will be prepared to pay Biobizkaia only) The amount of ________________ plus taxes (if applicable), will be paid per completed patient (Table II of Annex II). Biobizkaia will distribute the payments as follows: 10% of the Study total will be assigned to Biobizkaia to defray the cost incurred in the managing the running of the Study. The remaining costs will be distributed as follows: 30% will be assigned to the site investigator to promote research (Table II of Annex II). 70% will be assigned to the investigator team. (Table II of Annex II). (Option 1) As indicated by the Principal Investigator, said amount thereof shall be paid directly to Biobizkaia for reinvestment in the R & D activities of the Investigator or the Research Team. (Option 2) This compensation will be reimbursed directly by the Sponsor to the Investigator Team, in the account designated by the PI or following the indications of the invoice issued. In those studies that due to their size or by being considered an area of special interest or impact for the Basque Country Health System, in the negotiating of the Agreement Biobizkaia reserves the legal authority to adapt or adjust the distribution of the chargeable invoice amounts. Form of payment The calculation of the amount of work done in the Study for invoicing purposes will be notified to Biobizkaia by the Sponsor and in parallel by the Principal Investigator, so that Biobizkaia may submit the corresponding invoices, after having verified the details. Sponsor will pay the invoice submitted by Biobizkaia in a maximum period of thirty (30) days from the date each invoice was submitted, into the account number designated by the Organization / Institute. All the obligations demanded in compliance RD 957/2020 y RD 577/2013 will be met by the Sponsor. The Sponsor will also be responsible for obtaining the mandatory approvals, from the EC (CEIm), prior to starting the Study. The Principal Investigator will execute the Study, under the terms described and agreed RD 957/2020 y el RD 577/2013. The Principal Investigator will be limited to observing the reality without changing it, without actively introducing pharmacological treatment/s and without making visits or additional tests. Under no circumstances will the medicinal products which are being observed in this Study be used for non-approved indications or under conditions of use different to those established in their summary of product characteristics, the Sponsor and the Principal Investigator guaranteeing that this is complied with. The Site will help the professionals who must participate in the execution of the Study fulfill their functions in its facilities, in particular those of the Principal Investigator, the Monitor, and the rest of the investigation personnel. Biobizkaia will be responsible for the financial and administrative management of the funds for the execution of the Study. The Sponsor must communicate the effective start date of the Study to the EC,(CEIm) t and Biobizkaia, as well as to prepare the final report, the annual follow up report or Report of the Study status, if so requested and if applicable according to that established in Art.. 9d del Royal Decree 957/2020 The Sponsor must inform ▇▇▇▇▇▇▇▇▇▇ of the finalizing of the Study with a period of 90 days. The period will be reduced to 15 days in the event of early termination. If any significant incident is detected it will be notified immediately to the EC (CEIm) involved, and Biobizkaia. In the event of adverse reactions, they will be notified following the criteria and timelines stated in art 15 Royal Decree 957/2020. The Study may be suspended under the following cases: Due to non-fulfillment of the obligations that are the responsibility of the Parties according to the present Agreement, if this non-fulfillment has not been corrected by the non-fulfilling Party within a period of thirty (30) days, counting from the receipt of written communication in which the fulfilling Party requests the fulfillment of the aforementioned obligations. If compliance with the Protocol is deficient or the data are repeatedly incomplete or inexact. By mutual accord between all the Parties of the Agreement, that must be established in writing. The Study Sponsor reserves the right to stop the enrolment of patients in any of the following cases: If the Principal Investigator does not enroll, without justification accepted by both Parties, the agreed number of patients during the designated period of time. If the total number of patients that have to be enrolled in the Study is achieved by the different investigators who participate in the Study when it is a multicentre Study. In the event of early termination of the Study, the Sponsor will only pay for the services that have been performed up to the date of the early termination, except the patients who might have to withdraw from the Study due to an adverse effect attributable or arising from the Study, and not anticipated in the Protocol. These will be considered, for invoicing and payment purposes, as if all the visits had been made. In the case of patients who withdraw for other reasons, the amount to pay will be calculated in proportion to the patients enrolled. The conditions of the present Agreement will be regulated and interpreted in accordance with the applicable regulations on matters of studies and especially with that laid down in RD 957/2020 and in the RD 577/2013. In the event of controversy in the interpretation or fulfillment of the present Agreement, the Parties, with express relinquishment of any other to which they could resort, are subject to the Jurisdiction of the Courts of Vitoria-Gasteiz, headquarter of Osakidetza. In the case of different language versions of this Agreement, the version signed in Spanish will prevail over the English one for all Parties. And as approval of all the aforementioned, and in witness thereof, the Parties sign the present document.