FINANCIAL ASPECTS. The cost of this TRIAL has been initially budgeted at EUROS, not including VAT, (€ ) (hereinafter, the TRIAL Budget), in accordance with the provisions of the Financial Memorandum for the TRIALS (Schedule I), which specifies all their financial aspects. This amount does not, in any case whatsoever, include an obligation or inducement for the HOSPITAL, the FOUNDATION, and/or the LEAD INVESTIGATOR to recommend, prescribe, buy, use or arrange the use of any of the SPONSOR’s products. To request an invoice, contact: xxxxxxxxxxx.xxxx@xxxxx.xxxxxx.xxx In addition, upon signature of this contract, the SPONSOR/CRO (choose as appropriate) will pay the amount of 4,000/3,000 Euros, in a one-time, non-refundable payment, as administrative and contractual management costs. This payment will include expenses for CEIm evaluation, relevant amendments, contract management administration and addendum to the contract. This payment will include expenses for contract management administrative procedures and addendum to the contract. If the fiscal details of this invoice are different from those detailed for visitor invoices in clause 5.4., please indicate them below: Invoices will be issued to: Name: Invoices will be sent for processing to the following e-mail: The amount to be paid by the SPONSOR/CRO (choose as appropiate) during performance of the TRIALS will be calculated by applying Schedule I and must be paid to the FOUNDATION in the payments set out below: The TRIALS budget will be paid, at least, every six months in accordance with the details in the amounts table by visit and subject signed up included in Schedule I, until the total amount of the Budget has been paid. For that purpose, SPONSOR/CRO (choose as appropiate) and the LEAD INVESTIGATOR will report to the FOUNDATION every six months. These payments are considered to be payments on account, pending payment of the definitive total for the TRIALS. The definitive total to be paid by the SPONSOR/CRO (choose as appropiate) for performing the TRIALS will be calculated based on the work effectively carried out to perform the TRIALS (hereinafter, the Definitive Total). The Definitive Total will be calculated as follows: Within a maximum of three (3) months after termination of the TRIALS at the HOSPITAL, the SPONSOR/CRO (choose as appropiate) SPONSOR/CRO (choose as appropriate) and the LEAD INVESTIGATOR will notify the FOUNDATION in writing of the total number of: (1) subjects signed up and assessed, (2) visits effectively paid, (3) incidents occurring, and (4) any hospital test, analysis, exploration, appointment or stay of an extraordinary nature which may have occurred, whether or not they are reflected in the Financial Memorandum (Schedule I). As soon as possible after the information referred to in the previous paragraph has been notified, the FOUNDATION will calculate, issue and notify the SPONSOR/CRO (choose as appropiate), in a final invoice for the trials, the amount of the definitive total and, if necessary, claim the amounts pending payment, which must be paid within one (1) month, without the need for a subsequent request. Once the final payment is made, it will be understood that the SPONSOR’s financial obligations have concluded. All payments must be made on submission of the invoice, to which VAT will be added in accordance with the applicable law on the date it is issued on, in the name of the SPONSOR or the ENTITY/PERSON IN CHARGE OF FINANCIAL ASPECTS (invoicing details) Name: Invoices will be sent for processing to the following e-mail: The SPONSOR/CRO must communicate by email to FIBHU12O the total amount that must be invoiced for the visits that have been made, detailing the breakdown of each of these visits and procedures detailed in the Economic Report (ANNEX_I). For this, must send an e-mail to xxxxxxxxxxx.xxxx@xxxxx.xxxxxx.xxx Payments to the FOUNDATION will be made by bank transfer, with charges payable by the sender, 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 Payments made by the SPONSOR/CRO (choose as appropiate) to the FOUNDATION will be full settlements for the former, with the FOUNDATION being responsible for payment the amounts that, as appropriate, are payable to the TRIALS researchers. The PARTIES agree that, if the HOSPITAL lacks the necessary equipment for adequate performance of the TRIALS, the SPONSOR will provide the HOSPITAL with it, free-of-charge and assigning its use, either directly or via a third party. Furthermore, the SPONSOR will pay the cost, and arrange the supply, installation, maintenance, calibration and removal of the equipment, and training personnel in operating it, if necessary. The HOSPITAL, the FOUNDATION and the LEAD INVESTIGATOR will, in no case, be liable for its maintenance or its eventual loss. The equipment will consist of the following components: The Equipment will remain the property of the SPONSOR, or a third party, and will carry the relevant identification to show this. The Equipment may only be used to perform the TRIAL and, when it has ended, will be returned to the SPONSOR, or a third party, at no cost to the HOSPITAL or the FOUNDATION. When the LEAD INVESTIGATOR receives a request for return, they will make the Equipment available to the SPONSOR, or the third party appointed by it to collect it. On termination of the TRIALS, the SPONSOR may assign the Equipment to the HOSPITAL free-of-charge, for which purpose such documents as are necessary will be formalised. In the event that additional needs for equipment are detected during performance of the TRIALS, subsequent to the signature of this contract, the PARTIES must sign an addendum including the equipment made available, respecting the terms and conditions set out in the previous paragraphs.
Appears in 2 contracts
Samples: Contract for Performance of Clinical Trials, Contract for Performance of Low Intervention Level Clinical Trials
FINANCIAL ASPECTS. The cost of this TRIAL has been initially budgeted at EUROS, not including VAT, (€ ) (hereinafter, the TRIAL Budget), in accordance with the provisions of the Financial Memorandum for the TRIALS (Schedule I), which specifies all their financial aspects. This amount does not, in any case whatsoever, include an obligation or inducement for the HOSPITAL, the FOUNDATION, and/or the LEAD INVESTIGATOR to recommend, prescribe, buy, use or arrange the use of any of the SPONSOR’s products. To request an invoice, contact: xxxxxxxxxxx.xxxx@xxxxx.xxxxxx.xxx In addition, upon signature of this contract, the SPONSOR/CRO (choose as appropriate) will pay the amount of 4,000/3,000 Euros, in a one-time, non-refundable payment, as administrative and contractual management costs. This payment will include includes expenses for CEIm CEIm's evaluation, relevant amendments, administrative formalities for the management of the contract management administration and addendum addendum/s to the contract. / This payment will include expenses includes administrative costs for the management of the contract management administrative procedures and addendum addendum/s to the contract. If the fiscal details of this invoice are different from those detailed for visitor invoices in clause 5.4., please indicate them below: Invoices Invoice will be issued to: Name: Invoices Invoice will be sent for processing to the following e-mail: The amount to be paid by the SPONSOR/CRO (choose as appropiate) during appropiate) during performance of the TRIALS will be calculated by applying Schedule I and must be paid to the FOUNDATION in the payments set out below: The TRIALS budget will be paid, at least, every six months in accordance with the details in the amounts table by visit and subject signed up included in Schedule I, until the total amount of the Budget has been paid. For that purpose, SPONSOR/CRO (choose as appropiate) and the LEAD INVESTIGATOR will report to the FOUNDATION every six months. These payments are considered to be payments on account, pending payment of the definitive total for the TRIALS. The definitive total to be paid by the SPONSOR/CRO (choose as appropiate) for performing the TRIALS will be calculated based on the work effectively carried out to perform the TRIALS (hereinafter, the Definitive Total). The Definitive Total will be calculated as follows: Within a maximum of three (3) months after termination of the TRIALS at the HOSPITAL, the SPONSOR/CRO (choose as appropiate) SPONSOR/CRO (choose as appropriate) and the LEAD INVESTIGATOR will notify the FOUNDATION in writing of the total number of: (1) subjects signed up and assessed, (2) visits effectively paid, (3) incidents occurring, and (4) any hospital test, analysis, exploration, appointment or stay of an extraordinary nature which may have occurred, whether or not they are reflected in the Financial Memorandum (Schedule I). As soon as possible after the information referred to in the previous paragraph has been notified, the FOUNDATION will calculate, issue and notify the SPONSOR/CRO (choose as appropiate), in a final invoice for the trials, the amount of the definitive total and, if necessary, claim the amounts pending payment, which must be paid within one (1) month, without the need for a subsequent request. Once the final payment is made, it will be understood that the SPONSOR’s financial obligations have concluded. All payments must be made on submission of the invoice, to which VAT will be added in accordance with the applicable law on the date it is issued on, in the name of the SPONSOR or the ENTITY/PERSON IN CHARGE OF FINANCIAL ASPECTS (invoicing details) established. Invoices will be issued to: Name: Invoices will be sent for processing to the following e-mail: The SPONSOR/CRO must communicate by email to FIBHU12O the total amount that must be invoiced for the visits that have been made, detailing the breakdown of each of these visits and procedures detailed in the Economic Report (ANNEX_I). For this, must send an e-mail to xxxxxxxxxxx.xxxx@xxxxx.xxxxxx.xxx Payments to the FOUNDATION will be made by bank transfer, with charges payable by the sender, 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 ESG-83727016 Payments made by the SPONSOR/CRO (choose as appropiate) to the FOUNDATION will be full settlements for the former, with the FOUNDATION being responsible for payment the amounts that, as appropriate, are payable to the TRIALS researchers. The PARTIES agree that, if the HOSPITAL lacks the necessary equipment for adequate performance of the TRIALS, the SPONSOR will provide the HOSPITAL with it, free-of-charge and assigning its use, either directly or via a third party. Furthermore, the SPONSOR will pay the cost, and arrange the supply, installation, maintenance, calibration and removal of the equipment, and training personnel in operating it, if necessary. The HOSPITAL, the FOUNDATION and the LEAD INVESTIGATOR will, in no case, be liable for its maintenance or its eventual loss. The equipment will consist of the following components: The Equipment will remain the property of the SPONSOR, or a third party, and will carry the relevant identification to show this. The Equipment may only be used to perform the TRIAL TRIALS and, when it has they have ended, will be returned to the SPONSOR, or a third party, at no cost to the HOSPITAL or the FOUNDATION. When the LEAD INVESTIGATOR receives a request for return, they will make the Equipment available to the SPONSOR, or the third party appointed by it to collect it. On termination of the TRIALS, the SPONSOR may assign the Equipment to the HOSPITAL free-of-charge, for which purpose such documents as are necessary will be formalised. In the event that additional needs for equipment are detected during performance of the TRIALS, subsequent to the signature of this contract, the PARTIES must sign an addendum including the equipment made available, respecting the terms and conditions set out in the previous paragraphs.
Appears in 2 contracts
Samples: Clinical Trials Agreement, Contract for Performance of Clinical Trials
FINANCIAL ASPECTS. The initial estimated cost of this TRIAL has been initially budgeted at EUROS, not including VAT, amounts to ___________ EUROS (___________€ ) (hereinafter, the TRIAL Trial Budget). This amount has been calculated through the application of the cost of __________ EUROS (___________€) per evaluable subject, in accordance with that established in the provisions Financial Report of the Financial Memorandum for TRIAL (Annex I) in which all the TRIALS (Schedule I), which specifies all their financial aspects. This amount does not, in any case whatsoever, include an obligation or inducement for the HOSPITAL, the FOUNDATION, and/or the LEAD INVESTIGATOR to recommend, prescribe, buy, use or arrange the use of any aspects of the SPONSOR’s productssame are specified. To request an invoice, contact: xxxxxxxxxxx.xxxx@xxxxx.xxxxxx.xxx In addition, upon signature of this contract, the SPONSOR/CRO (choose as appropriate) will pay the amount of 4,000/3,000 Euros, in a one-time, non-refundable payment, as administrative and contractual management costs. This payment will include expenses for CEIm evaluation, relevant amendments, contract management administration and addendum to the contract. This payment will include expenses for contract management administrative procedures and addendum to the contract. If the fiscal details of this invoice are different from those detailed for visitor invoices in clause 5.4., please indicate them below: Invoices will be issued to: Name: Invoices will be sent for processing to the following e-mail: The amount to be paid by the SPONSOR/CRO (choose as appropiate) during performance SPONSOR during the period of the TRIALS will TRIAL shall be calculated by applying Schedule determined through the application of Annex I and must shall be paid to the FOUNDATION in accordance with the payments set out belowfollowing terms: 600€ shall be paid at the moment that this Contract is signed (administrative and management concept). The TRIALS budget will TRIAL Budget shall be paid, at leasta minimum, every six months half-yearly in accordance with the details that specified in the table of amounts table by per visit and subject signed up recruited patients included in Schedule Annex I, until the total amount full payment of the Budget has been paidamount which constitutes the said Budget. For that purposeTo this effect, SPONSOR/CRO (choose as appropiate) the SPONSOR and the LEAD PRINCIPAL INVESTIGATOR will report to shall keep the FOUNDATION every six monthsinformed on a quarterly basis. These payments are considered to shall be deemed payments on account, pending payment subject to the settlement of the definitive total for final amount of the TRIALSTRIAL. The definitive total to be paid final amount payable by the SPONSOR/CRO (choose as appropiate) for performing SPONSOR or carrying out the TRIALS will TRIAL shall be calculated based on determined according to the work activity effectively carried out to perform during the TRIALS period of the TRIAL (hereinafter, the Definitive TotalFinal Amount). The Definitive Total will Final Amount shall be calculated as follows: Within In a maximum period of three (3) months after from the termination of the TRIALS at TRIAL in the HOSPITAL, the SPONSOR/CRO (choose as appropiate) SPONSOR/CRO (choose as appropriate) SPONSOR and the LEAD PRINCIPAL INVESTIGATOR will shall notify the FOUNDATION in writing of the total number of: (1i) the subjects signed up recruited and assessedevaluated, (2ii) the visits effectively paidactually made, (3iii) the incidents occurringthat occurred, and as well as (4iv) any hospital extraordinary test, analysis, explorationexamination, appointment consultation or stay of an extraordinary nature which may have occurred, hospital admittance that occurred whether or not they are reflected in the Financial Memorandum Report (Schedule Annex I). As soon as possible after the submission of the information referred to in the previous paragraph has been notifiedparagraph, the FOUNDATION will calculate, issue shall calculate the Final Amount for the TRIAL and notify the SPONSOR/CRO (choose as appropiate)Parties involved and, in a final invoice for the trialswhere applicable, the amount any amounts pending payment by any of the definitive total and, if necessary, claim same. This Final Amount settlement shall determine the amounts pending payment, which must due for each Party and shall be paid by the resulting creditors within a period of one (1) month, month without the need for a subsequent request. Once the final payment is made, it will be understood that the SPONSOR’s financial obligations have concludedany further correspondence being required. All payments must shall be made based on the submission of the invoice, an invoice to which VAT will be added applied in accordance with the applicable law legislation in effect on the date it is issued onof issue of the same, and in the name of the SPONSOR or the ENTITY/PERSON IN CHARGE OF FINANCIAL ASPECTS (invoicing details) Name: Invoices will be sent for processing to the following e-mail: The SPONSOR/CRO must communicate by email to FIBHU12O the total amount that must be invoiced for the visits that have been made, detailing the breakdown of each of these visits and procedures detailed in the Economic Report (ANNEX_I). For this, must send an e-mail to xxxxxxxxxxx.xxxx@xxxxx.xxxxxx.xxx Payments to the FOUNDATION will shall be made by bank transfertransfers, with all charges payable to be borne by the senderoriginator, to: Holder/Beneficiary: Name. “Fundación para la Investigación Biomédica del Hospital Universitario 12 Puerta de octubreHierro Majadahonda” Bank. Bank“BANCO DE SANTANDER” Account number. 0049 1976 32 2610000382 IBAN CODE. XX0000000000000000000000 SWIFT. XXXXXXXXXXX Invoices shall be issued in the name of: Caixabank(include name, S.A. Addressaddress and fiscal identification number) And shall be sent to: 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 (include postal address and contact department/person). Payments made by the SPONSOR/CRO (choose as appropiate) SPONSOR to the FOUNDATION will shall be full settlements totally final for the former, with the FOUNDATION being shall be responsible for the payment of the amounts thatamounts, as appropriatewhere applicable, are payable that correspond to the TRIALS researchers. The PARTIES agree that, if the HOSPITAL lacks the necessary equipment for adequate performance of the TRIALS, the SPONSOR will provide the HOSPITAL with it, free-of-charge and assigning its use, either directly Investigators or via a third party. Furthermore, the SPONSOR will pay the cost, and arrange the supply, installation, maintenance, calibration and removal of the equipment, and training personnel in operating it, if necessary. The HOSPITAL, the FOUNDATION and the LEAD INVESTIGATOR will, in no case, be liable for its maintenance or its eventual loss. The equipment will consist of the following components: The Equipment will remain the property of the SPONSOR, or a third party, and will carry the relevant identification to show this. The Equipment may only be used to perform the TRIAL and, when it has ended, will be returned to the SPONSOR, or a third party, at no cost to the HOSPITAL or the FOUNDATION. When the LEAD INVESTIGATOR receives a request for return, they will make the Equipment available to the SPONSOR, or the third party appointed by it to collect it. On termination of the TRIALS, the SPONSOR may assign the Equipment to the HOSPITAL free-of-charge, for which purpose such documents as are necessary will be formalised. In the event that additional needs for equipment are detected during performance of the TRIALS, subsequent to the signature of this contract, the PARTIES must sign an addendum including the equipment made available, respecting the terms and conditions set out subjects involved in the previous paragraphsTRIAL.
Appears in 1 contract
Samples: Clinical Trial Agreement
FINANCIAL ASPECTS. The cost of this TRIAL has been initially budgeted at EUROS, not including VAT, __________EUROS (______€ ) (hereinafterTRIAL 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 Budget), in accordance with the provisions of the Financial Memorandum for the TRIALS (Schedule IAnnex 1), which specifies all their financial economic aspects. This amount does not, in not cover or provide for any case whatsoever, include an obligation or inducement commitment for the HOSPITAL, the FOUNDATION, Foundation and/or the LEAD PRINCIPAL INVESTIGATOR to recommend, endorse, prescribe, buypurchase, use or arrange agree the use of any of the SPONSOR’s products. To request an invoiceThe study budget includes a unique payment, contact: xxxxxxxxxxx.xxxx@xxxxx.xxxxxx.xxx In additionregardless of the number of patients included in the trial., upon signature of this ONE THOUSAND EUROS (1.000€) for the Pharmacy Service and a unique payment of TWO THOUSAND EUROS (2.000 €) for management of the present contract, the SPONSOR/CRO (choose as appropriate) will pay the amount of 4,000/3,000 Euros, in a one-time, non-refundable payment, as administrative and contractual management costs. This payment will include expenses for CEIm evaluation, relevant amendments, contract management administration and addendum according to the contractestablished in the Study Budget (Annex I). This payment will include expenses for contract management administrative procedures and addendum to the contract. If the fiscal details of this invoice are different from those detailed for visitor invoices in clause 5.4., please indicate them below: Invoices will be issued to: Name: Invoices will be sent for processing to the following e-mail: The amount sum to be paid by the SPONSORSPONSOR/CRO (choose as appropiate) during performance during the implementation of the TRIALS will CLINICAL TRIAL shall be calculated by applying set according to the specifications of Schedule I 1, and must shall be paid to the FOUNDATION as detailed below: THREE THOUSAND EUROS (3.000€), non refundable, will be paid at contract signature, in the payments set out belowconcept of: A unique payment of ONE THOUSAND EUROS (1.000€), regardless of the number of patients included in the trial for the Pharmacy Service. A unique payment of TWO THOUSAND EUROS (2.000€) to the FOUNDATION, in concept of contract management. The TRIALS remainder of the CLINICAL TRIAL budget will shall be paid, at leastleast each semester, every six months in accordance with the details as detailed in the amounts table by of cost per visit and subject signed up recruited patient included in as Schedule I, 1 until the total amount cost of the Budget has been paidbudget is fully paid off. For that purpose, SPONSOR/CRO (choose as appropiate) The SPONSOR and the LEAD PRINCIPAL INVESTIGATOR will shall report to the FOUNDATION every six monthson a biyearly basis. These payments are instalments shall be considered as partial payments, subject to be payments on account, pending payment the settlement of the definitive final total expenses of the CLINICAL TRIAL. The final contribution of the SPONSOR for the TRIALS. The definitive total to implementation of the CLINICAL TRIAL shall be paid determined by the SPONSOR/CRO (choose as appropiate) for performing the TRIALS will be calculated based on the work effectively activities actually carried out to perform while conducting the TRIALS CLINICAL TRIAL (hereinafter, the Definitive Total‘Final cost’). The Definitive Total will Final cost shall be calculated estimated as follows: Within a maximum of three (3) months after termination from completion of the TRIALS TRIAL at the HOSPITAL, the SPONSOR/CRO (choose as appropiate) SPONSOR/CRO (choose as appropriate) and the LEAD PRINCIPAL INVESTIGATOR will notify shall report in writing to the FOUNDATION in writing of the total number of: of (1) subjects signed up recruited and assessedevaluated subjects, (2) visits effectively paidactual number of visits, (3) incidents occurringresulting incidents, and as well as (4) any tests, analyses, examinations, consultations or hospital test, analysis, exploration, appointment or stay stays of an extraordinary special nature which may that might have occurred, whether or not they are reflected included in the Financial Memorandum Schedule (Schedule I1). As soon as possible after the information referred to in of the previous paragraph point has been notified, the FOUNDATION will calculate, issue shall calculate and notify the SPONSORSPONSOR/CRO (choose as appropiate), in a the final invoice for the trials, the amount payment of the definitive total andCLINICAL TRIAL, as well as the outstanding sums, if necessary, claim the amounts pending paymentany, which must shall be paid within one (1) month, month without the need for a subsequent requestfurther requirement. Once This settlement of the final payment is made, it will shall be understood that regarded to all effects as due compliance by the SPONSOR’s SPONSOR of his financial obligations have concludedobligations. All payments must shall be made on submission upon the presentation of an invoice; the invoicecorresponding VAT shall be included as per current legislation at the time of payment, to which VAT will be added in accordance with the applicable law on the date it is issued on, in at the name of the SPONSOR or the ENTITY/PERSON IN CHARGE OF FINANCIAL ASPECTS (invoicing details) Nameonly legalized subsidiary in Spain). Invoices will be issued to the sponsor: _________ Invoices issued to the sponsor shall be provided by the following payer whose details are as follows: _________________ Invoices will be sent for processing to the following e-mailaddress management: The SPONSOR/CRO must communicate by email to FIBHU12O the total amount that must be invoiced for the visits that have been made, detailing the breakdown of each of these visits and procedures detailed in the Economic Report (ANNEX_I). For this, must send an e-mail to xxxxxxxxxxx.xxxx@xxxxx.xxxxxx.xxx Payments ________ All payments to the FOUNDATION will Foundation shall be made by bank transfer, transfer (with charges payable bank fees being paid by the sender, payer) to: Holder/BeneficiaryName: Fundación para la Investigación Biomédica del Hospital Universitario 12 de octubre. BankXxxxxxxx Xxxxxxx Banking Entity: Caixabank, S.A. AddressBankia Account number: Xxxxx xx xx Xxxxxxxxxx, 00 0x 00000-Xxxxxx Account Nº/IBAN2038 1163 13 6000526076 IBAN: XX00 0000 0000 0000 0000 0000 SWIFT CODEES 86 2038 1163 13 6000526076 SWIFT: CAIXE SBBxxx VAT number /Tax ID CODECAHMESMMXXX CIF: X-00000000 Payments made by the SPONSOR/CRO (choose as appropiate) to the FOUNDATION will be full settlements for the former, with the FOUNDATION being responsible for payment the amounts that, as appropriate, are payable to the TRIALS researchers. The PARTIES agree that, if the HOSPITAL lacks the necessary equipment for adequate performance of the TRIALS, the SPONSOR will provide the HOSPITAL with it, free-of-charge and assigning its use, either directly or via a third party. Furthermore, the SPONSOR will pay the cost, and arrange the supply, installation, maintenance, calibration and removal of the equipment, and training personnel in operating it, if necessary. The HOSPITAL, the FOUNDATION and the LEAD INVESTIGATOR will, in no case, be liable for its maintenance or its eventual loss. The equipment will consist of the following components: The Equipment will remain the property of the SPONSOR, or a third party, and will carry the relevant identification to show this. The Equipment may only be used to perform the TRIAL and, when it has ended, will be returned to the SPONSOR, or a third party, at no cost to the HOSPITAL or the FOUNDATION. When the LEAD INVESTIGATOR receives a request for return, they will make the Equipment available to the SPONSOR, or the third party appointed by it to collect it. On termination of the TRIALS, the SPONSOR may assign the Equipment to the HOSPITAL free-of-charge, for which purpose such documents as are necessary will be formalised. In the event that additional needs for equipment are detected during performance of the TRIALS, subsequent to the signature of this contract, the PARTIES must sign an addendum including the equipment made available, respecting the terms and conditions set out in the previous paragraphs.X-00000000
Appears in 1 contract
FINANCIAL ASPECTS. The cost of this TRIAL has been initially budgeted at EUROS, not including VAT, __________EUROS (______€ ) (hereinafterTRIAL budget, from now on) of which 78% was for the RESEARCH TEAM and 22% indirect costs for the FOUNDATION. 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 Budget), in accordance with the provisions of the Financial Memorandum for the TRIALS (Schedule IAnnex 1), which specifies all their financial economic aspects. This amount does not, in not cover or provide for any case whatsoever, include an obligation or inducement commitment for the HOSPITAL, the FOUNDATION, Foundation and/or the LEAD PRINCIPAL INVESTIGATOR to recommend, endorse, prescribe, buypurchase, use or arrange agree the use of any of the SPONSOR’s products. To request an invoiceThe study budget includes a unique payment, contact: xxxxxxxxxxx.xxxx@xxxxx.xxxxxx.xxx In addition, upon signature regardless of this the number of patients included in the trial. of XXXXX EUROS (XXXX€) for the Pharmacy Service and a unique payment of ONE THOUSAND FIVE HUNDRED EUROS (1.500 €) for management of the present contract, the SPONSOR/CRO (choose as appropriate) will pay the amount of 4,000/3,000 Euros, in a one-time, non-refundable payment, as administrative and contractual management costs. This payment will include expenses for CEIm evaluation, relevant amendments, contract management administration and addendum according to the contractestablished in the Study Budget (Annex I). This payment will include expenses for contract management administrative procedures and addendum to the contract. If the fiscal details of this invoice are different from those detailed for visitor invoices in clause 5.4., please indicate them below: Invoices will be issued to: Name: Invoices will be sent for processing to the following e-mail: The amount sum to be paid by the SPONSORSPONSOR/CRO (choose as appropiate) during performance during the implementation of the TRIALS will CLINICAL TRIAL shall be calculated by applying set according to the specifications of Schedule I 1, and must shall be paid to the FOUNDATION as detailed below: XXXXXX EUROS (XXXX€), non refundable, will be paid at contract signature, in the payments set out belowconcept of: A unique payment of ____________________ (000€), regardless of the number of patients included in the trial for the Pharmacy Service. IF APPLICABLE A unique payment of __________________ (1.500€) to the FOUNDATION, in concept of contract management. The TRIALS remainder of the CLINICAL TRIAL budget will shall be paid, at leastleast each semester, every six months in accordance with the details as detailed in the amounts table by of cost per visit and subject signed up recruited patient included in as Schedule I, 1 until the total amount cost of the Budget has been paidbudget is fully paid off. For that purpose, SPONSOR/CRO (choose as appropiate) The SPONSOR and the LEAD PRINCIPAL INVESTIGATOR will shall report to the FOUNDATION every six monthson a biyearly basis. These payments are instalments shall be considered as partial payments, subject to be payments on account, pending payment the settlement of the definitive final total expenses of the CLINICAL TRIAL. The final contribution of the SPONSOR for the TRIALS. The definitive total to implementation of the CLINICAL TRIAL shall be paid determined by the SPONSOR/CRO (choose as appropiate) for performing the TRIALS will be calculated based on the work effectively activities actually carried out to perform while conducting the TRIALS CLINICAL TRIAL (hereinafter, the Definitive Total‘Final cost’). The Definitive Total will Final cost shall be calculated estimated as follows: Within a maximum of three (3) months after termination from completion of the TRIALS TRIAL at the HOSPITAL, the SPONSOR/CRO (choose as appropiate) SPONSOR/CRO (choose as appropriate) and the LEAD PRINCIPAL INVESTIGATOR will notify shall report in writing to the FOUNDATION in writing of the total number of: of (1) subjects signed up recruited and assessedevaluated subjects, (2) visits effectively paidactual number of visits, (3) incidents occurringresulting incidents, and as well as (4) any tests, analyses, examinations, consultations or hospital test, analysis, exploration, appointment or stay stays of an extraordinary special nature which may that might have occurred, whether or not they are reflected included in the Financial Memorandum Schedule (Schedule I1). As soon as possible after the information referred to in of the previous paragraph point has been notified, the FOUNDATION will calculate, issue shall calculate and notify the SPONSORSPONSOR/CRO (choose as appropiate), in a the final invoice for the trials, the amount payment of the definitive total andCLINICAL TRIAL, as well as the outstanding sums, if necessary, claim the amounts pending paymentany, which must shall be paid within one (1) month, month without the need for a subsequent requestfurther requirement. Once This settlement of the final payment is made, it will shall be understood that regarded to all effects as due compliance by the SPONSOR’s SPONSOR of his financial obligations have concludedobligations. All payments must shall be made on submission upon the presentation of an invoice; the invoicecorresponding VAT shall be included as per current legislation at the time of payment, to which VAT will be added in accordance with the applicable law on the date it is issued on, in at the name of the SPONSOR or the ENTITY/PERSON IN CHARGE OF FINANCIAL ASPECTS (invoicing details) Nameonly legalized subsidiary in Spain). Invoices will be issued to the sponsor: _________ Invoices issued to the sponsor shall be provided by the following payer whose details are as follows: _________________ Invoices will be sent for processing to the following e-mailaddress management: The SPONSOR/CRO must communicate by email to FIBHU12O the total amount that must be invoiced for the visits that have been made, detailing the breakdown of each of these visits and procedures detailed in the Economic Report (ANNEX_I). For this, must send an e-mail to xxxxxxxxxxx.xxxx@xxxxx.xxxxxx.xxx Payments ________ All payments to the FOUNDATION will Foundation shall be made by bank transfer, transfer (with charges payable bank fees being paid by the sender, payer) to: Holder/BeneficiaryName: Fundación para la Investigación Biomédica del Hospital Universitario 12 de octubre. BankGetafe Banking Entity: Caixabank, S.A. AddressBanco Santander Account number: Xxxxx xx xx Xxxxxxxxxx, 00 0x 000000049-Xxxxxx Account Nº/IBAN1982-21-2810000070 IBAN: XX00 0000 0000 0000 0000 0000 SWIFT CODE0000-0000-00-0000000000 SWIFT: CAIXE SBBxxx VAT number /Tax ID CODEXXXXXXXXXXX CIF: X-00000000 Payments made by the SPONSOR/CRO (choose as appropiate) to the FOUNDATION will be full settlements for the former, with the FOUNDATION being responsible for payment the amounts that, as appropriate, are payable to the TRIALS researchers. The PARTIES agree that, if the HOSPITAL lacks the necessary equipment for adequate performance of the TRIALS, the SPONSOR will provide the HOSPITAL with it, free-of-charge and assigning its use, either directly or via a third party. Furthermore, the SPONSOR will pay the cost, and arrange the supply, installation, maintenance, calibration and removal of the equipment, and training personnel in operating it, if necessary. The HOSPITAL, the FOUNDATION and the LEAD INVESTIGATOR will, in no case, be liable for its maintenance or its eventual loss. The equipment will consist of the following components: The Equipment will remain the property of the SPONSOR, or a third party, and will carry the relevant identification to show this. The Equipment may only be used to perform the TRIAL and, when it has ended, will be returned to the SPONSOR, or a third party, at no cost to the HOSPITAL or the FOUNDATION. When the LEAD INVESTIGATOR receives a request for return, they will make the Equipment available to the SPONSOR, or the third party appointed by it to collect it. On termination of the TRIALS, the SPONSOR may assign the Equipment to the HOSPITAL free-of-charge, for which purpose such documents as are necessary will be formalised. In the event that additional needs for equipment are detected during performance of the TRIALS, subsequent to the signature of this contract, the PARTIES must sign an addendum including the equipment made available, respecting the terms and conditions set out in the previous paragraphs.X-00000000
Appears in 1 contract
Samples: Clinical Trial Agreement
FINANCIAL ASPECTS. The cost of this TRIAL has been initially budgeted at EUROS, not including VAT, __________EUROS (______€ ) (hereinafterTRIAL budget, from now on) of which 78% was for the RESEARCH TEAM and 22% indirect costs for the FOUNDATION. 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 Budget), in accordance with the provisions of the Financial Memorandum for the TRIALS (Schedule IAnnex 1), which specifies all their financial economic aspects. This amount does not, in not cover or provide for any case whatsoever, include an obligation or inducement commitment for the HOSPITAL, the FOUNDATION, Foundation and/or the LEAD PRINCIPAL INVESTIGATOR to recommend, endorse, prescribe, buypurchase, use or arrange agree the use of any of the SPONSOR’s products. To request an invoice, contact: xxxxxxxxxxx.xxxx@xxxxx.xxxxxx.xxx In addition, upon signature The study budget includes a unique payment of this ____________________ (1.500 €) for management of the present contract, the SPONSOR/CRO (choose as appropriate) will pay the amount of 4,000/3,000 Euros, in a one-time, non-refundable payment, as administrative and contractual management costs. This payment will include expenses for CEIm evaluation, relevant amendments, contract management administration and addendum according to the contractestablished in the Study Budget (Annex I). This payment will include expenses for contract management administrative procedures and addendum to the contract. If the fiscal details of this invoice are different from those detailed for visitor invoices in clause 5.4., please indicate them below: Invoices will be issued to: Name: Invoices will be sent for processing to the following e-mail: The amount sum to be paid by the SPONSORSPONSOR/CRO (choose as appropiate) during performance during the implementation of the TRIALS will CLINICAL TRIAL shall be calculated by applying set according to the specifications of Schedule I 1, and must shall be paid to the FOUNDATION as detailed below: _______________ EUROS (1.500€), non refundable, will be paid at contract signature, in the payments set out below: concept of contract management. The TRIALS remainder of the CLINICAL TRIAL budget will shall be paid, at leastleast each semester, every six months in accordance with the details as detailed in the amounts table by of cost per visit and subject signed up recruited patient included in as Schedule I, 1 until the total amount cost of the Budget has been paidbudget is fully paid off. For that purpose, SPONSOR/CRO (choose as appropiate) The SPONSOR and the LEAD PRINCIPAL INVESTIGATOR will shall report to the FOUNDATION every six monthson a biyearly basis. These payments are instalments shall be considered as partial payments, subject to be payments on account, pending payment the settlement of the definitive final total expenses of the CLINICAL TRIAL. The final contribution of the SPONSOR for the TRIALS. The definitive total to implementation of the CLINICAL TRIAL shall be paid determined by the SPONSOR/CRO (choose as appropiate) for performing the TRIALS will be calculated based on the work effectively activities actually carried out to perform while conducting the TRIALS CLINICAL TRIAL (hereinafter, the Definitive Total‘Final cost’). The Definitive Total will Final cost shall be calculated estimated as follows: Within a maximum of three (3) months after termination from completion of the TRIALS TRIAL at the HOSPITAL, the SPONSOR/CRO (choose as appropiate) SPONSOR/CRO (choose as appropriate) and the LEAD PRINCIPAL INVESTIGATOR will notify shall report in writing to the FOUNDATION in writing of the total number of: of (1) subjects signed up recruited and assessedevaluated subjects, (2) visits effectively paidactual number of visits, (3) incidents occurringresulting incidents, and as well as (4) any tests, analyses, examinations, consultations or hospital test, analysis, exploration, appointment or stay stays of an extraordinary special nature which may that might have occurred, whether or not they are reflected included in the Financial Memorandum Schedule (Schedule I1). As soon as possible after the information referred to in of the previous paragraph point has been notified, the FOUNDATION will calculate, issue shall calculate and notify the SPONSORSPONSOR/CRO (choose as appropiate), in a the final invoice for the trials, the amount payment of the definitive total andCLINICAL TRIAL, as well as the outstanding sums, if necessary, claim the amounts pending paymentany, which must shall be paid within one (1) month, month without the need for a subsequent requestfurther requirement. Once This settlement of the final payment is made, it will shall be understood that regarded to all effects as due compliance by the SPONSOR’s SPONSOR of his financial obligations have concludedobligations. All payments must shall be made on submission upon the presentation of an invoice; the invoicecorresponding VAT shall be included as per current legislation at the time of payment, to which VAT will be added in accordance with the applicable law on the date it is issued on, in at the name of the SPONSOR or the ENTITY/PERSON IN CHARGE OF FINANCIAL ASPECTS (invoicing details) Nameonly legalized subsidiary in Spain). Invoices will be issued to the sponsor: _________ Invoices issued to the sponsor shall be provided by the following payer whose details are as follows: _________________ Invoices will be sent for processing to the following e-mailaddress management: The SPONSOR/CRO must communicate by email to FIBHU12O the total amount that must be invoiced for the visits that have been made, detailing the breakdown of each of these visits and procedures detailed in the Economic Report (ANNEX_I). For this, must send an e-mail to xxxxxxxxxxx.xxxx@xxxxx.xxxxxx.xxx Payments ________ All payments to the FOUNDATION will Foundation shall be made by bank transfer, transfer (with charges payable bank fees being paid by the sender, payer) to: Holder/BeneficiaryName: Fundación para la Investigación Biomédica del Hospital Universitario 12 de octubre. BankGetafe Banking Entity: Caixabank, S.A. AddressBanco Santander Account number: Xxxxx xx xx Xxxxxxxxxx, 00 0x 000000049-Xxxxxx Account Nº/IBAN1982-21-2810000070 IBAN: XX00 0000 0000 0000 0000 0000 SWIFT CODE0000-0000-00-0000000000 SWIFT: CAIXE SBBxxx VAT number /Tax ID CODEXXXXXXXXXXX CIF: X-00000000 Payments made by the SPONSOR/CRO (choose as appropiate) to the FOUNDATION will be full settlements for the former, with the FOUNDATION being responsible for payment the amounts that, as appropriate, are payable to the TRIALS researchers. The PARTIES agree that, if the HOSPITAL lacks the necessary equipment for adequate performance of the TRIALS, the SPONSOR will provide the HOSPITAL with it, free-of-charge and assigning its use, either directly or via a third party. Furthermore, the SPONSOR will pay the cost, and arrange the supply, installation, maintenance, calibration and removal of the equipment, and training personnel in operating it, if necessary. The HOSPITAL, the FOUNDATION and the LEAD INVESTIGATOR will, in no case, be liable for its maintenance or its eventual loss. The equipment will consist of the following components: The Equipment will remain the property of the SPONSOR, or a third party, and will carry the relevant identification to show this. The Equipment may only be used to perform the TRIAL and, when it has ended, will be returned to the SPONSOR, or a third party, at no cost to the HOSPITAL or the FOUNDATION. When the LEAD INVESTIGATOR receives a request for return, they will make the Equipment available to the SPONSOR, or the third party appointed by it to collect it. On termination of the TRIALS, the SPONSOR may assign the Equipment to the HOSPITAL free-of-charge, for which purpose such documents as are necessary will be formalised. In the event that additional needs for equipment are detected during performance of the TRIALS, subsequent to the signature of this contract, the PARTIES must sign an addendum including the equipment made available, respecting the terms and conditions set out in the previous paragraphs.G-83728024
Appears in 1 contract
Samples: Clinical Trial Agreement
FINANCIAL ASPECTS. The cost of this TRIAL has been initially budgeted at EUROS, not including VAT, __________EUROS (______€ ) (hereinafterTRIAL 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 Budget), in accordance with the provisions of the Financial Memorandum for the TRIALS (Schedule IAnnex 1), which specifies all their financial economic aspects. This amount does not, in not cover or provide for any case whatsoever, include an obligation or inducement commitment for the HOSPITAL, the FOUNDATION, Foundation and/or the LEAD PRINCIPAL INVESTIGATOR to recommend, endorse, prescribe, buypurchase, use or arrange agree the use of any of the SPONSOR’s products. To request an invoice, contact: xxxxxxxxxxx.xxxx@xxxxx.xxxxxx.xxx In addition, upon signature The study budget includes a unique payment of this TWO THOUSAND EUROS (2.000 €) for management of the present contract, the SPONSOR/CRO (choose as appropriate) will pay the amount of 4,000/3,000 Euros, in a one-time, non-refundable payment, as administrative and contractual management costs. This payment will include expenses for CEIm evaluation, relevant amendments, contract management administration and addendum according to the contractestablished in the Study Budget (Annex I). This payment will include expenses for contract management administrative procedures and addendum to the contract. If the fiscal details of this invoice are different from those detailed for visitor invoices in clause 5.4., please indicate them below: Invoices will be issued to: Name: Invoices will be sent for processing to the following e-mail: The amount sum to be paid by the SPONSORSPONSOR/CRO (choose as appropiate) during performance during the implementation of the TRIALS will CLINICAL TRIAL shall be calculated by applying set according to the specifications of Schedule I 1, and must shall be paid to the FOUNDATION as detailed below: TWO THOUSAND EUROS (2.000€), non refundable, will be paid at contract signature, in the payments set out below: concept of contract management. The TRIALS remainder of the CLINICAL TRIAL budget will shall be paid, at leastleast each semester, every six months in accordance with the details as detailed in the amounts table by of cost per visit and subject signed up recruited patient included in as Schedule I, 1 until the total amount cost of the Budget has been paidbudget is fully paid off. For that purpose, SPONSOR/CRO (choose as appropiate) The SPONSOR and the LEAD PRINCIPAL INVESTIGATOR will shall report to the FOUNDATION every six monthson a biyearly basis. These payments are instalments shall be considered as partial payments, subject to be payments on account, pending payment the settlement of the definitive final total expenses of the CLINICAL TRIAL. The final contribution of the SPONSOR for the TRIALS. The definitive total to implementation of the CLINICAL TRIAL shall be paid determined by the SPONSOR/CRO (choose as appropiate) for performing the TRIALS will be calculated based on the work effectively activities actually carried out to perform while conducting the TRIALS CLINICAL TRIAL (hereinafter, the Definitive Total‘Final cost’). The Definitive Total will Final cost shall be calculated estimated as follows: Within a maximum of three (3) months after termination from completion of the TRIALS TRIAL at the HOSPITAL, the SPONSOR/CRO (choose as appropiate) SPONSOR/CRO (choose as appropriate) and the LEAD PRINCIPAL INVESTIGATOR will notify shall report in writing to the FOUNDATION in writing of the total number of: of (1) subjects signed up recruited and assessedevaluated subjects, (2) visits effectively paidactual number of visits, (3) incidents occurringresulting incidents, and as well as (4) any tests, analyses, examinations, consultations or hospital test, analysis, exploration, appointment or stay stays of an extraordinary special nature which may that might have occurred, whether or not they are reflected included in the Financial Memorandum Schedule (Schedule I1). As soon as possible after the information referred to in of the previous paragraph point has been notified, the FOUNDATION will calculate, issue shall calculate and notify the SPONSORSPONSOR/CRO (choose as appropiate), in a the final invoice for the trials, the amount payment of the definitive total andCLINICAL TRIAL, as well as the outstanding sums, if necessary, claim the amounts pending paymentany, which must shall be paid within one (1) month, month without the need for a subsequent requestfurther requirement. Once This settlement of the final payment is made, it will shall be understood that regarded to all effects as due compliance by the SPONSOR’s SPONSOR of his financial obligations have concludedobligations. All payments must shall be made on submission upon the presentation of an invoice; the invoicecorresponding VAT shall be included as per current legislation at the time of payment, to which VAT will be added in accordance with the applicable law on the date it is issued on, in at the name of the SPONSOR or the ENTITY/PERSON IN CHARGE OF FINANCIAL ASPECTS (invoicing details) Nameonly legalized subsidiary in Spain). Invoices will be issued to the sponsor: _________ Invoices issued to the sponsor shall be provided by the following payer whose details are as follows: _________________ Invoices will be sent for processing to the following e-mailaddress management: The SPONSOR/CRO must communicate by email to FIBHU12O the total amount that must be invoiced for the visits that have been made, detailing the breakdown of each of these visits and procedures detailed in the Economic Report (ANNEX_I). For this, must send an e-mail to xxxxxxxxxxx.xxxx@xxxxx.xxxxxx.xxx Payments ________ All payments to the FOUNDATION will Foundation shall be made by bank transfer, transfer (with charges payable bank fees being paid by the sender, payer) to: Holder/BeneficiaryName: Fundación para la Investigación Biomédica del Hospital Universitario 12 de octubre. BankXxxxxxxx Xxxxxxx Banking Entity: Caixabank, S.A. AddressBankia Account number: Xxxxx xx xx Xxxxxxxxxx, 00 0x 00000-Xxxxxx Account Nº/IBAN2038 1163 13 6000526076 IBAN: XX00 0000 0000 0000 0000 0000 SWIFT CODEES 86 2038 1163 13 6000526076 SWIFT: CAIXE SBBxxx VAT number /Tax ID CODECAHMESMMXXX CIF: X-00000000 Payments made by the SPONSOR/CRO (choose as appropiate) to the FOUNDATION will be full settlements for the former, with the FOUNDATION being responsible for payment the amounts that, as appropriate, are payable to the TRIALS researchers. The PARTIES agree that, if the HOSPITAL lacks the necessary equipment for adequate performance of the TRIALS, the SPONSOR will provide the HOSPITAL with it, free-of-charge and assigning its use, either directly or via a third party. Furthermore, the SPONSOR will pay the cost, and arrange the supply, installation, maintenance, calibration and removal of the equipment, and training personnel in operating it, if necessary. The HOSPITAL, the FOUNDATION and the LEAD INVESTIGATOR will, in no case, be liable for its maintenance or its eventual loss. The equipment will consist of the following components: The Equipment will remain the property of the SPONSOR, or a third party, and will carry the relevant identification to show this. The Equipment may only be used to perform the TRIAL and, when it has ended, will be returned to the SPONSOR, or a third party, at no cost to the HOSPITAL or the FOUNDATION. When the LEAD INVESTIGATOR receives a request for return, they will make the Equipment available to the SPONSOR, or the third party appointed by it to collect it. On termination of the TRIALS, the SPONSOR may assign the Equipment to the HOSPITAL free-of-charge, for which purpose such documents as are necessary will be formalised. In the event that additional needs for equipment are detected during performance of the TRIALS, subsequent to the signature of this contract, the PARTIES must sign an addendum including the equipment made available, respecting the terms and conditions set out in the previous paragraphs.X-00000000
Appears in 1 contract
Samples: Agreement for Conducting the Clinical Trial With Medical Device
FINANCIAL ASPECTS. The cost of this CLINICAL TRIAL has been initially budgeted at EUROS, _________ EUROS not including VAT, VAT (€ ____) (hereinafter, hereinafter the CLINICAL TRIAL Budget), in accordance with the provisions Financial Report of the Financial Memorandum for the TRIALS CLINICAL TRIAL (Schedule Annex I), in which specifies all their financial aspectsaspects of the same are specified. This amount does notnot represent, in under any case whatsoevercircumstances, include an any obligation or inducement for of the HOSPITAL, the FOUNDATION, FOUNDATION and/or the LEAD PRINCIPAL INVESTIGATOR to recommend, prescribe, buypurchase, use, or agree to use or arrange the use of any of the SPONSOR’s 's products. To request an invoice, contact: xxxxxxxxxxx.xxxx@xxxxx.xxxxxx.xxx In addition, upon signature of this contract, the SPONSOR/CRO (choose as appropriate) will pay the amount of 4,000/3,000 Euros, in a one-time, non-refundable payment, as administrative and contractual management costs. This payment will include expenses for CEIm evaluation, relevant amendments, contract management administration and addendum to the contract. This payment will include expenses for contract management administrative procedures and addendum to the contract. If the fiscal details of this invoice are different from those detailed for visitor invoices in clause 5.4., please indicate them below: Invoices will be issued to: Name: Invoices will be sent for processing to the following e-mail: The amount to be paid by the SPONSORSPONSOR/CRO (choose as appropiate) during performance during the conduct of the TRIALS will CLINICAL TRIAL shall be calculated determined by applying Schedule the application of Annex I and must shall be paid to the FOUNDATION in according to the payments set out belowfollowing payment scheme: 600€ shall be invoiced upon the signature of this contract for Foundation´s administrative and management expenses. This amount shall be non-refundable The TRIALS budget will rest of the TRIAL Budget shall be paid, at least, every six months in accordance with semiannually according to the details in contents of the table of amounts table by per visit and subject signed up per recruited patient included in Schedule Annex I, until the total amount full payment of the amount constituting the said Budget has been paidmade. For that purposethese purposes, SPONSORthe SPONSOR/CRO (choose as appropiate) and the LEAD PRINCIPAL INVESTIGATOR will shall send a report to the FOUNDATION every six monthssemiannually. These payments are considered to shall be treated as payments on account, pending payment dependent upon the liquidation of the definitive total for final amount of the TRIALSCLINICAL TRIAL. The definitive total final amount to be paid by the SPONSORSPONSOR/CRO for the conduct of the CLINICAL TRIAL shall be determined by the amount of activity actually performed for the conduct of the CLINICAL TRIAL (choose as appropiate) for performing hereinafter the TRIALS will be calculated based on the work effectively carried out to perform the TRIALS (hereinafter, the Definitive TotalFinal Amount). The Definitive Total will final amount shall be calculated as follows: Within a maximum of three (3) three months after termination from the completion of the TRIALS CLINICAL TRIAL at the HOSPITAL, the SPONSOR/CRO (choose as appropiate) SPONSOR/CRO (choose as appropriate) and the LEAD PRINCIPAL INVESTIGATOR will notify shall report to the FOUNDATION FOUNDATION, in writing of writing, the total number of: (1) subjects signed up recruited and assessedevaluated, (2) visits effectively paidactually completed, (3) incidents occurringoccurred, and as well as (4) any hospital extraordinary test, analysis, explorationexamination, appointment consultation, or stay of an extraordinary nature which may have hospitalisation that occurred, regardless of whether or not they are it was reflected in the Financial Memorandum Report (Schedule Annex I). As soon as possible after the communication of the information referred to discussed in the previous paragraph has been notifiedpoint, the FOUNDATION will shall calculate, issue issue, and notify inform the SPONSORSPONSOR/CRO (choose as appropiate)through the final trial invoice, in a regarding the liquidation of the final amount, and also, if applicable, shall invoice for the trials, the amount of the definitive total and, if necessary, claim the amounts pending payment, which must shall be paid within one (1) month, without further requirement. Upon the need for a subsequent request. Once liquidation of the final payment is madepayment, it will be understood that the SPONSOR’s financial obligations of the SPONSOR shall be considered to have concludedbeen fulfilled. All payments must shall be made on submission against presentation of the invoice, to which VAT will shall be added applied in accordance with the applicable law legislation prevailing on the date it is issued onof issuance of the invoice, in the name of by the SPONSOR or the ENTITY/PERSON IN CHARGE OF FINANCIAL ASPECTS established PAYING AGENT. (invoicing detailsfiscal data) NameThe invoices shall be issued to: Invoices will And they shall be sent for processing to the following e-mailaddress: The SPONSOR/CRO must communicate by email to FIBHU12O the total amount that must be invoiced for the visits that have been made, detailing the breakdown of each of these visits and procedures detailed in the Economic Report (ANNEX_I). For this, must send an e-mail to xxxxxxxxxxx.xxxx@xxxxx.xxxxxx.xxx Payments to the FOUNDATION will shall be made by bank transfer, with charges payable by at the senderpayor'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 Payments made by the SPONSOR/CRO (choose as appropiate) to the FOUNDATION will be full settlements for the former, with the FOUNDATION being responsible for payment the amounts that, as appropriate, are payable to the TRIALS researchers. The PARTIES agree that, if the HOSPITAL lacks the necessary equipment for adequate performance of the TRIALS, the SPONSOR will provide the HOSPITAL with it, free-of-charge and assigning its use, either directly or via a third party. Furthermore, the SPONSOR will pay the cost, and arrange the supply, installation, maintenance, calibration and removal of the equipment, and training personnel in operating it, if necessary. The HOSPITAL, the FOUNDATION and the LEAD INVESTIGATOR will, in no case, be liable for its maintenance or its eventual loss. The equipment will consist of the following components: The Equipment will remain the property of the SPONSOR, or a third party, and will carry the relevant identification to show this. The Equipment may only be used to perform the TRIAL and, when it has ended, will be returned to the SPONSOR, or a third party, at no cost to the HOSPITAL or the FOUNDATION. When the LEAD INVESTIGATOR receives a request for return, they will make the Equipment available to the SPONSOR, or the third party appointed by it to collect it. On termination of the TRIALS, the SPONSOR may assign the Equipment to the HOSPITAL free-of-charge, for which purpose such documents as are necessary will be formalised. In the event that additional needs for equipment are detected during performance of the TRIALS, subsequent to the signature of this contract, the PARTIES must sign an addendum including the equipment made available, respecting the terms and conditions set out in the previous paragraphs.:
Appears in 1 contract
Samples: Clinical Trial Agreement