FINANCIAL ASPECTS. The cost of this CLINICAL RESEARCH has been initially budgeted at EUROS (€ ) (hereinafter, Research Budget). This cost has been determined by applying a cost of EUROS (€ ) per evaluable subject, as established by the Payment Schedule of the CLINICAL RESEARCH (Annex I), which specifies all its economic aspects. The amount to be paid by the SPONSOR/CRO (choose as appropriate) during the execution of the CLINICAL RESEARCH will be determined by application of Annex I and shall be paid to the FOUNDATION. The SPONSOR/CRO (choose as appropriate) and the PRINCIPAL INVESTIGATOR shall inform the FOUNDATION, at least every six months, of the number of patients included and visits carried out, as detailed in Annex I, on the basis of which the FOUNDATION shall issue the corresponding invoices until the full amount constituting the Budget has been paid. These payments are considered as payments on account, dependent on the settlement of the final amount of the CLINICAL RESEARCH. The final amount to be paid by the SPONSOR/CRO (choose as appropriate) for the execution of the CLINICAL RESEARCH shall be determined on the basis of the activity actually carried out for the execution of the CLINICAL RESEARCH (hereinafter, the Final Amount). The Final Amount shall be calculated as follows: Within a maximum of (3) three months from the completion of the CLINICAL RESEARCH at the HOSPITAL the SPONSOR/CRO (choose as appropriate) and the PRINCIPAL INVESTIGATOR shall communicate in writing to the FOUNDATION the total number of: (i) subjects recruited and evaluated, (ii) visits actually carried out, (iii) incidents that have occurred, as well as (iv) of any test, analysis, examination, consultation or hospital stay, of an extraordinary nature that has occurred, whether or not they are reflected in the Economic Report (Annex I). All payments must be made within 30 days against presentation of the invoice, to which VAT tax will be applied in accordance with the regulations applicable on the date of issue of the invoice and in the name of the SPONSOR or FINANCIAL RESPONSIBLE established. NAME CIF/VAT NUMBER/ ID NAME e-mail The SPONSOR/CRO must communicate by e-mail to the FOUNDATION the total amount to be invoiced, detailing the breakdown of the visits and procedures that have been carried out. For this, must send an e-mail to xxxxxxxxxxx.xxxx@xxxxx.xxxxxx.xxx Payment shall be made by bank transfer, at the payer's expense, to: Holder/Beneficiary: Fundación para la Investigación Biomédica del Hospital Universitario 12 de Octubre Bank: Caixabank, S.A. Address: Xxxxx xx xx Xxxxxxxxxx, 00 0x 00000-Xxxxxx Account Nº/IBAN: XX00 0000 0000 0000 0000 0000 SWIFT CODE: CAIXE SBBxxx VAT number /Tax ID CODE: X-00000000 The payments made by the SPONSOR/CRO (choose as appropriate) shall be performed through the FOUNDATION in 30 days, which shall fully clear the debt of the former. It shall be the FOUNDATION’S responsibility to distribute the corresponding amounts to the Investigators or CLINICAL RESEARCH subjects, as applicable. Furthermore, upon signature of this contract, the SPONSOR/CRO (choose as appropriate) will pay the amount of 2,500/2,000 Euros -vat not included-, in a one-time, non-refundable payment, as administrative and contractual management costs. This payment includes expenses for CEIm's evaluation, relevant amendments, administrative formalities for the management of the contract and addendum/s to the contract. / This payment includes administrative costs for the management of the contract and addendum/s to the contract. NAME CIF/VAT NUMBER/ ID NAME e-mail SIX - INSURANCE AND LIABILITIES. APPLIES / NOT APPLICABLE The SPONSOR has taken out a civil liability insurance policy which, in all its aspects, complies with the provisions of RD 1090/2015. The policy, No. , was arranged with the insurance company and is current, as the SPONSOR is up-to-date with the premiums. The policy also explicitly includes the PRINCIPAL INVESTIGATOR, their collaborators, and the HOSPITAL and the FOUNDATION within its coverage (a copy of the policy or certificate of it is attached).
Appears in 2 contracts
Samples: Clinical Research Agreement, Contract for the Performance of Clinical Research With Medical Devices
FINANCIAL ASPECTS. The cost of this CLINICAL RESEARCH STUDY has been initially budgeted at EUROS (€ ) (hereinafter, Research Study Budget). This cost has been determined by applying a cost of EUROS (€ ) per evaluable subject, as established by the Payment Schedule of the CLINICAL RESEARCH STUDY (Annex I), which specifies all its economic aspects. The amount to be paid by the SPONSOR/CRO (choose as appropriate) during the execution of the CLINICAL RESEARCH STUDY will be determined by application of Annex I and shall be paid to the FOUNDATION. The SPONSOR/CRO (choose as appropriate) and the PRINCIPAL INVESTIGATOR shall inform the FOUNDATION, at least every six months, of the number of patients included and visits carried out, as detailed in Annex I, on the basis of which the FOUNDATION shall issue the corresponding invoices until the full amount constituting the Budget has been paid. These payments are considered as payments on account, dependent on the settlement of the final amount of the CLINICAL RESEARCHSTUDY. The final amount to be paid by the SPONSOR/CRO (choose as appropriate) for the execution of the CLINICAL RESEARCH STUDY shall be determined on the basis of the activity actually carried out for the execution of the CLINICAL RESEARCH STUDY (hereinafter, the Final Amount). The Final Amount shall be calculated as follows: Within a maximum of (3) three months from the completion of the CLINICAL RESEARCH STUDY at the HOSPITAL the SPONSOR/CRO (choose as appropriate) and the PRINCIPAL INVESTIGATOR shall communicate in writing to the FOUNDATION the total number of: (i) subjects recruited and evaluated, (ii) visits actually carried out, (iii) incidents that have occurred, as well as (iv) of any test, analysis, examination, consultation or hospital stay, of an extraordinary nature that has occurred, whether or not they are reflected in the Economic Report (Annex I). All payments must be made within 30 days against presentation of the invoice, to which VAT tax will be applied in accordance with the regulations applicable on the date of issue of the invoice and in the name of the SPONSOR or FINANCIAL ECONOMIC RESPONSIBLE established. NAME CIF/VAT NUMBER/ ID NAME e-mail The SPONSOR/CRO must communicate by e-mail to the FOUNDATION the total amount to be invoiced, detailing the breakdown of the visits and procedures that have been carried out. For this, must send an e-mail to xxxxxxxxxxx.xxxx@xxxxx.xxxxxx.xxx Payment shall be made by bank transfer, at the payer's expense, to: Holder/Beneficiary: Fundación para la Investigación Biomédica del Hospital Universitario 12 de Octubre Bank: Caixabank, S.A. Address: Xxxxx xx xx Xxxxxxxxxx, 00 0x 00000-Xxxxxx Account Nº/IBAN: XX00 0000 0000 0000 0000 0000 SWIFT CODE: CAIXE SBBxxx VAT number /Tax ID CODE: X-00000000 The payments made by the SPONSOR/CRO (choose as appropriate) shall be performed through the FOUNDATION in 30 days, which shall fully clear the debt of the former. It shall be the FOUNDATION’S responsibility to distribute the corresponding amounts to the Investigators or CLINICAL RESEARCH study subjects, as applicable. Furthermore, upon signature of this contract, the SPONSOR/CRO (choose as appropriate) will pay the amount of 2,500/2,000 Euros -vat not included-Euros, in a one-time, non-refundable payment, as administrative and contractual management costs. This payment includes expenses for CEIm's evaluation, relevant amendments, administrative formalities for the management of the contract and addendum/s to the contract. / This payment includes administrative costs for the management of the contract and addendum/s to the contract. NAME CIF/VAT NUMBER/ ID NAME e-mail SIX - INSURANCE AND LIABILITIES. APPLIES / NOT APPLICABLE The SPONSOR has taken out a civil liability insurance policy which, in all its aspects, complies with the provisions of RD 1090/2015. The policy, No. , was arranged with the insurance company and is current, as the SPONSOR is up-to-date with the premiums. The policy also explicitly includes the PRINCIPAL INVESTIGATOR, their collaborators, and the HOSPITAL and the FOUNDATION within its coverage (a copy of the policy or certificate of it is attached).
Appears in 1 contract
Samples: Contract for the Implementation of the Observational Study
FINANCIAL ASPECTS. The cost of this CLINICAL RESEARCH STUDY has been initially budgeted at EUROS (€ ) (hereinafter, Research Study Budget). This cost has been determined by applying a cost of EUROS (€ ) per evaluable subject, as established by the Payment Schedule of the CLINICAL RESEARCH STUDY (Annex I), which specifies all its economic aspects. The amount to be paid by the SPONSOR/CRO (choose as appropriate) during the execution of the CLINICAL RESEARCH STUDY will be determined by application of Annex I and shall be paid to the FOUNDATION. The SPONSOR/CRO (choose as appropriate) and the PRINCIPAL INVESTIGATOR shall inform the FOUNDATION, at least every six months, of the number of patients included and visits carried out, as detailed in Annex I, on the basis of which the FOUNDATION shall issue the corresponding invoices until the full amount constituting the Budget has been paid. These payments are considered as payments on account, dependent on the settlement of the final amount of the CLINICAL RESEARCHSTUDY. The final amount to be paid by the SPONSOR/CRO (choose as appropriate) for the execution of the CLINICAL RESEARCH STUDY shall be determined on the basis of the activity actually carried out for the execution of the CLINICAL RESEARCH STUDY (hereinafter, the Final Amount). The Final Amount shall be calculated as follows: Within a maximum of (3) three months from the completion of the CLINICAL RESEARCH STUDY at the HOSPITAL the SPONSOR/CRO (choose as appropriate) and the PRINCIPAL INVESTIGATOR shall communicate in writing to the FOUNDATION the total number of: (i) subjects recruited and evaluated, (ii) visits actually carried out, (iii) incidents that have occurred, as well as (iv) of any test, analysis, examination, consultation or hospital stay, of an extraordinary nature that has occurred, whether or not they are reflected in the Economic Report (Annex I). All payments must be made within 30 days against presentation of the invoice, to which VAT tax will be applied in accordance with the regulations applicable on the date of issue of the invoice and in the name of the SPONSOR or FINANCIAL ECONOMIC RESPONSIBLE established. NAME CIF/VAT NUMBER/ ID NAME e-mail The SPONSOR/CRO must communicate by e-mail to the FOUNDATION the total amount to be invoiced, detailing the breakdown of the visits and procedures that have been carried out. For this, must send an e-mail to xxxxxxxxxxx.xxxx@xxxxx.xxxxxx.xxx Payment shall be made by bank transfer, at the payer's expense, to: Holder/Beneficiary: Fundación para la Investigación Biomédica del Hospital Universitario 12 de Octubre Bank: Caixabank, S.A. Address: Xxxxx xx xx Xxxxxxxxxx, 00 0x 00000-Xxxxxx Account Nº/IBAN: XX00 0000 0000 0000 0000 0000 SWIFT CODE: CAIXE SBBxxx VAT number /Tax ID CODE: X-00000000 The payments made by the SPONSOR/CRO (choose as appropriate) shall be performed through the FOUNDATION in 30 days, which shall fully clear the debt of the former. It shall be the FOUNDATION’S responsibility to distribute the corresponding amounts to the Investigators or CLINICAL RESEARCH study subjects, as applicable. Furthermore, upon signature of this contract, the SPONSOR/CRO (choose as appropriate) will pay the amount of 2,500/2,000 Euros -vat not included-Euros, in a one-time, non-refundable payment, as administrative and contractual management costs. This payment includes expenses for CEIm's evaluation, relevant amendments, administrative formalities for the management of the contract and addendum/s to the contract. / This payment includes administrative costs for the management of the contract and addendum/s to the contract. NAME CIF/VAT NUMBER/ ID NAME e-mail SIX - INSURANCE AND LIABILITIES. APPLIES / NOT APPLICABLE The SPONSOR has taken out a civil liability insurance policy which, in all its aspects, complies with the provisions of RD 1090/2015. The policy, No. , was arranged with the insurance company and is current, as the SPONSOR is up-to-date with the premiums. The policy also explicitly includes the PRINCIPAL INVESTIGATOR, their collaborators, and the HOSPITAL and the FOUNDATION within its coverage (a copy of the policy or certificate of it is attached).
Appears in 1 contract
FINANCIAL ASPECTS. The cost of this CLINICAL RESEARCH TRIAL has been initially budgeted estimated at EUROS __________EURO (VAT not included) (€ ____) (hereinafterhereinafter the ‘CLINICAL TRIAL Budget’) as per the Economic Memorandum attached as Annex 1 to this Agreement, Research Budget). This cost has been determined by applying a cost where full detail of EUROS (€ ) per evaluable subject, as established by the Payment Schedule financial aspects of the CLINICAL RESEARCH (Annex I)TRIAL is given. This amount does not cover or provide for any obligation or commitment for the HOSPITAL, which specifies all its economic aspectsthe FOUNDATION and/or the PRINCIPAL INVESTIGATOR to recommend, endorse, prescribe, purchase, use or agree the use of any of the SPONSOR’s products. To request an invoice, contact: xxxxxxxxxxx.xxxx@xxxxx.xxxxxx.xxx. The amount to be paid by the SPONSORSPONSOR/CRO (choose as appropriate) during the execution implementation of the CLINICAL RESEARCH will TRIAL shall be determined by application set according to the specifications of Annex I 1, and shall be paid to the FOUNDATIONFOUNDATION as detailed below: The CLINICAL 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 fully paid off. The SPONSOR/CRO (choose as appropriate) SPONSOR and the PRINCIPAL INVESTIGATOR shall inform the FOUNDATION, at least every six months, of the number of patients included and visits carried out, as detailed in Annex I, on the basis of which report to the FOUNDATION on a biyearly basis and the PRINCIPAL INVESTIGATOR shall issue the corresponding invoices until the full amount constituting the Budget has been paidreview and approve all items to be billed. These payments are instalments shall be considered as payments on accountpartial payments, dependent on subject to the settlement of the final amount total expenses of the CLINICAL RESEARCHTRIAL. The final amount to be paid by contribution of the SPONSOR/CRO (choose as appropriate) SPONSOR for the execution implementation of the CLINICAL RESEARCH TRIAL shall be determined on by the basis of the activity activities actually carried out for the execution of while conducting the CLINICAL RESEARCH TRIAL (hereinafter, the ‘Final Amountcost’). The Final Amount cost shall be calculated estimated as follows: Within a maximum of three (3) three months from the completion of the CLINICAL RESEARCH TRIAL at the HOSPITAL HOSPITAL, the SPONSORSPONSOR/CRO (choose as appropriate) and the PRINCIPAL INVESTIGATOR shall communicate report in writing to the FOUNDATION the total number of: of (i1) subjects recruited and evaluatedevaluated subjects, (ii2) visits actually carried outactual number of visits, (iii3) incidents that have occurredresulting incidents, as well as (iv4) of any testtests, analysisanalyses, examinationexaminations, consultation consultations or hospital stay, stays of an extraordinary special nature that has might have occurred, whether or not they are reflected included in the Economic Report Financial Schedule (Annex ISchedule 1). As soon as possible after the information of the previous point has been notified, the FOUNDATION shall calculate and notify the SPONSOR/CRO of the final payment of the CLINICAL TRIAL, as well as the outstanding sums, if any, which shall be paid within one (1) month without further requirement. This settlement of the final payment shall be regarded to all effects as due compliance by the SPONSOR of his financial obligations. All payments must shall be made within 30 days against presentation after submitting an invoice; the corresponding VAT shall be included as per current legislation at the time of the invoicepayment, to which VAT tax will be applied in accordance with the regulations applicable on the date of issue of the invoice and in at the name of the SPONSOR or the ENTITY/PERSON IN CHARGE OF FINANCIAL RESPONSIBLE established. NAME CIF/VAT NUMBER/ ID NAME e-mail The SPONSOR/CRO must communicate by e-mail ASPECTS (invoicing details) All payments to the FOUNDATION the total amount to be invoiced, detailing the breakdown of the visits and procedures that have been carried out. For this, must send an e-mail to xxxxxxxxxxx.xxxx@xxxxx.xxxxxx.xxx Payment shall be made by bank transfertransfer within 30 days, at with bank fees being paid by the payer's expense, to: Holder/BeneficiaryAccount number.: Fundación para la Investigación Biomédica del Hospital Universitario 12 de Octubre Bank: Caixabank, S.A. Address: Xxxxx xx xx Xxxxxxxxxx, 00 0x 00000-Xxxxxx Account Nº/IBAN2100 5478 71 0200025607 IBAN: XX00 0000 0000 0000 0000 0000 SWIFT CODE: CAIXE SBBxxx VAT number /Tax / Tax ID CODENumber: X-00000000 The payments ESG-83727016 Payments made by the SPONSORSPONSOR/CRO (choose as appropriate) to the FOUNDATION shall be performed in full satisfaction by the former of its obligations, being the FOUNDATION’s responsibility to pay the sums, if any, due to the researchers and/or the subjects of the trial. The amount of 1,500 € -VAT not included- will be paid through the FOUNDATION in 30 days, which shall fully clear the debt administrative process upon signing this agreement regardless of the former. It shall be the FOUNDATION’S responsibility to distribute the corresponding amounts to the Investigators or CLINICAL RESEARCH subjects, as applicable. Furthermore, upon signature of this contract, the SPONSOR/CRO (choose as appropriate) will pay the amount of 2,500/2,000 Euros -vat not included-, in a one-time, non-refundable payment, as administrative and contractual management costs. This payment includes expenses for CEIm's evaluation, relevant amendments, administrative formalities for the management total cost of the contract and addendum/s to the contract. / This payment includes administrative costs for the management of the contract and addendum/s to the contract. NAME CIF/VAT NUMBER/ ID NAME e-mail SIX - INSURANCE AND LIABILITIES. APPLIES / NOT APPLICABLE The SPONSOR has taken out a civil liability insurance policy which, in all its aspects, complies with the provisions of RD 1090/2015. The policy, No. , was arranged with the insurance company and is current, as the SPONSOR is up-to-date with the premiums. The policy also explicitly includes the PRINCIPAL INVESTIGATOR, their collaborators, and the HOSPITAL and the FOUNDATION within its coverage (a copy of the policy or certificate of it is attached)study.
Appears in 1 contract
Samples: Clinical Trial Agreement