Remuneration. 6.1 The remuneration agreed for each eligible, assessable patient whose treatment has been completed according to the Protocol and for whom the related CRF/eCRF has been duly compiled, including all the costs incurred by the Entity in execution of this Trial and the costs to cover all the related activities, is €_________ + VAT (if applicable) per patient (a total of € _______ +VAT (if applicable) for ____ patients) as specified in more detail in the Budget annexed in Annex A. 6.2 The Sponsor/CRO will pay the amount due under the terms of this article on the basis of a valid statement of account/supporting document, sent by the Sponsor to the Entity and agreed between the Parties. The above amount will be paid at the intervals indicated in the Budget (Annex A), on the basis of the number of patients enrolled during the period, the treatments carried out according to the Protocol, and in the presence of the duly completed CRF/eCRF duly compiled and validated by the Sponsor/CRO based on the activities carried out. (a) (where applicable, if the tests are done by a centre external to the Entity) Or (b) (where applicable, if the tests are carried out on the Entity’s premises) All the laboratory/instrument tests and any other services or additional activities not covered by the price agreed per eligible patient, and requested by the Sponsor as approved by the Ethics Committee and Competent Authority and as detailed in Annex A Part 2, shall be reimbursed and invoiced by the Sponsor/CRO in addition to the price paid for each eligible patient. 6.4 The Entity will not receive any remuneration for patients who cannot be assessed due to failure to observe the Protocol, violation of the rules of Good Clinical Practice or failure to comply with the laws applicable to clinical drug trials. The Entity will have no right to receive any remuneration for any patient enrolled after notification of interruption and/or conclusion of the Trial by the Sponsor/CRO, or any number beyond the maximum number of patients stipulated under the terms of this Agreement, if not agreed with the Sponsor. 6.5 (where applicable) The Sponsor/CRO shall also reimburse the Entity (or the executor, appointed for this purpose by the Entity and in agreement with the latter) with all the additional costs of medical/diagnostic activities, including hospital admissions, which are not provided for in the Protocol or amendments to the Protocol, and which are not already covered by the above payments, if such activities are essential for the proper clinical treatment of a patient undergoing the trial. The reimbursement will only be paid on condition that such activities and costs have been properly communicated, with justification, and have been documented in writing to the Sponsor/CRO and approved in writing by the Sponsor/CRO, provided the obligation that any patient’s personal data is communicated in coded form (by the Entity). 6.6 If, during the Trial, it is necessary to increase the financial support to the Entity, the Sponsor/CRO may supplement this Agreement by authorising the appropriate increase to the attached Budget. 6.7 In accordance with the 2018 Budget Act (paragraph 909) requiring, within the Italian territory, mandatory e-invoicing for sales of goods and services among private individuals, the Entity shall issue invoices in XML (Extensible Markup Language) format to Italian companies. Invoices are to be sent through the interchange system (SDI). The Sponsor/CRO shall provide the data necessary for the issue of the e-invoice: COMPANY NAME ______________________________ RECIPIENT CODE/CERTIFIED EMAIL: ________________ Tax ID ________________________________________ VAT no. ______________________________________ 6.8 The payments made for the Entity's services (i) represent the fair market value for those services, as they reflect the tariff scale applied by the Entity, (ii) were negotiated under normal market conditions, and (iii) were not agreed on the basis of the volume or value of prescriptions or in reference to those prescriptions or other financial activities between the Parties. Neither the Entity nor the Principal Investigator shall request any compensation or reimbursement from any other party in return for the activities performed or costs incurred by including the patients in the Trial, which the Sponsor/CRO is obligated to pay for. 6.9 (If provided for in the Protocol and if the legal conditions are met)
Appears in 3 contracts
Samples: Clinical Trial Agreement, Clinical Trial Agreement, Clinical Trial Agreement
Remuneration. 6.1 The remuneration agreed for each eligible, assessable patient whose treatment has been completed according to the Protocol and for whom the related CRF/eCRF has been duly compiled, including all the costs incurred by the Entity in execution of this Trial and the costs to cover all the related activities, is €_________ + VAT (if applicable) per patient (a total of € _______ +VAT (if applicable) for ____ patients) as specified in more detail in the Budget annexed in Annex A.
6.2 The Sponsor/CRO will pay the amount due under the terms of this article on the basis of a valid statement of account/supporting document, sent by the Sponsor to the Entity and agreed between the Parties. The above amount will be paid at the intervals indicated in the Budget (Annex A), on the basis of the number of patients enrolled during the period, the treatments carried out according to the Protocol, and in the presence of the duly completed CRF/eCRF duly compiled and validated by the Sponsor/CRO based on the activities carried out.
(a) (where applicable, if the tests are done by a centre external to the Entity) Or
(b) (where applicable, if the tests are carried out on the Entity’s premises) All the laboratory/instrument tests and any other services or additional activities not covered by the price agreed per eligible patient, and requested by the Sponsor as approved by the Ethics Committee and Competent Authority and as detailed in Annex A Part 2, shall be reimbursed and invoiced by the Sponsor/CRO in addition to the price paid for each eligible patient.
6.4 The Entity will not receive any remuneration for patients who cannot be assessed due to failure to observe the Protocol, violation of the rules of Good Clinical Practice or failure to comply with the laws applicable to clinical drug trials. The Entity will have no right to receive any remuneration for any patient enrolled after notification of interruption and/or conclusion of the Trial by the Sponsor/CRO, or any number beyond the maximum number of patients stipulated under the terms of this Agreement, if not agreed with the Sponsor.
6.5 (where applicable) The Sponsor/CRO shall also reimburse the Entity (or the executor, appointed for this purpose by the Entity and in agreement with the latter) with all the additional costs of medical/diagnostic activities, including hospital admissions, which are not provided for in the Protocol or amendments to the Protocol, and which are not already covered by the above payments, if such activities are essential for the proper clinical treatment of a patient undergoing the trial. The reimbursement will only be paid on condition that such activities and costs have been properly communicated, with justification, and have been documented in writing to the Sponsor/CRO and approved in writing by the Sponsor/CRO, provided the obligation that any patient’s personal data is communicated in coded form (by the Entity).
6.6 If, during the Trial, it is necessary to increase the financial support to the Entity, the Sponsor/CRO may supplement this Agreement by authorising the appropriate increase to the attached Budget.
6.7 In accordance with the 2018 Budget Act (paragraph 909) requiring, within the Italian territory, mandatory e-invoicing for sales of goods and services among private individuals, the Entity shall issue invoices in XML (Extensible Markup Language) format to Italian companies. Invoices are to be sent through the interchange system (SDI). The Sponsor/CRO shall provide the data necessary for the issue of the e-invoice: COMPANY NAME ______________________________ RECIPIENT CODE/CERTIFIED EMAIL: ________________ Tax ID ________________________________________ VAT no. ______________________________________
6.8 The payments made for the Entity's services (i) represent the fair market value for those services, as they reflect the tariff scale applied by the Entity, (ii) were negotiated under normal market conditions, and (iii) were not agreed on the basis of the volume or value of prescriptions or in reference to those prescriptions or other financial activities between the Parties. Neither the Entity nor the Principal Investigator shall request any compensation or reimbursement from any other party in return for the activities performed or costs incurred by including the patients in the Trial, which the Sponsor/CRO is obligated to pay for.
6.9 (If provided for in the Protocol and if the legal conditions are met)
Appears in 2 contracts
Remuneration. 6.1 6.1. The remuneration agreed for each eligible, assessable eligible valuable patient whose treatment who has been completed the study according to the Protocol and for whom the related CRF/eCRF has been duly compiled, including all the costs incurred by the Entity in execution of this the Trial and the costs to cover all the related activities, is €_________ equal to a maximum of € 30.827,00 + VAT (if applicable) per patient (a total of € _______ +VAT (if applicable) for ____ patients) as specified in more greater detail in the Budget annexed in Annex A.(Attachment A).
6.2 6.2. The CRO, on behalf of Sponsor/CRO , will pay the amount due under the terms of this article on the basis of a valid statement of account/supporting document, sent by the Sponsor to the Entity and document agreed between the Parties. The above amount will be paid at the intervals indicated in the Budget (Annex A, Paragraph “Payments and Invoices”), on the basis of the number of patients enrolled during the period, the treatments carried out according to the Protocol, Protocol and in the presence of the duly completed CRF/eCRF ECRF duly compiled and validated by the Sponsor/CRO Sponsor based on the activities carried out.
(a) (where applicable, if the tests are done by a centre external to the Entity) Or
(b) (where applicable, if the tests are carried out on the Entity’s premises) 6.3. All the laboratory/instrument tests and any other services or additional activities not covered by the price agreed per eligible patient, patient and requested by the Sponsor as approved by the Ethics Committee and Competent Authority and as detailed in Annex A (Paragraph “Costs and payments” – Part 2), shall be reimbursed and invoiced by the Sponsor/CRO on behalf of Sponsor in addition to the price paid for each eligible patient.
6.4 6.4. The Entity will not receive any no remuneration for patients who cannot be assessed due to failure to observe the Protocol, violation of the rules of Good Clinical Practice or failure to comply with the laws applicable to clinical drug trials. The Entity will have no right to receive any remuneration for any patient enrolled after notification of interruption and/or conclusion of the Trial by the Sponsor/CROSponsor/, or any number beyond the maximum number of patients stipulated under the terms of this Agreement, if not agreed with the Sponsor.
6.5 (where applicable) 6.5. The Sponsor/CRO on behalf of Sponsor shall also reimburse the Entity (or the executor, appointed for this purpose by the Entity and in agreement with the latter) with all the additional costs of medical/diagnostic activities, including hospital admissions, which are not provided for in the Protocol or amendments to the Protocol, and which are not already covered by the above payments, if such activities are essential for the proper clinical treatment of a patient undergoing the trialTrial. The reimbursement will only be paid on condition that such activities and costs have been properly communicated, with justification, and have been documented in writing to the Sponsor/CRO Sponsor and approved in writing by the Sponsor/CRO, and provided that the obligation that any patient’s personal data is communicated in coded form (by the Entity)anonymized form.
6.6 6.6. If, during the Trial, it is necessary to increase the financial support to the Entity, the Sponsor/CRO Sponsor may supplement this Agreement by authorising an addendum/amendment, authorizing the appropriate increase to the attached Budget.
6.7 6.7. In accordance with the 2018 Budget Act (paragraph 909) requiring, within the Italian territory, regulation on mandatory e-invoicing for sales of goods and services among private individuals, the Entity shall issue invoices in XML (Extensible Markup Language) format to Italian companiesformat. Invoices are to be sent through the interchange system (SDI). The Sponsor/CRO shall provide on behalf of Sponsor hereby provides the data necessary for the issue issuance of the e-invoice: COMPANY NAME ______________________________ HongKong Tigermed Co., Limited, Xxxxxx Xxxx Xx. 0000, 00xx Xxxxx, Xxxxxxx Xxxx, 218 Electric Road, North Point Hong Kong, RECIPIENT CODE: XXXXXXX Tax Registration Number: 58993572 AIFA National template 10-11-2022 Clinical Trial Agreement (CTA) PI Baldi V. 0.5 20 Sep 2023 ENTITY BANK ACCOUNT Name and surname of the beneficiary AZIENDA USL TOSCANA CENTRO Address of the beneficiary XXXXXX XXXXX XXXXX XXXXX, 1 50122 FIRENZE Name of the bank B.P.M. Bank address Xxxxxx Xxxxxxxxx 0, 00000 Xxxxxxx IBAN/CERTIFIED EMAIL: ________________ Tax ID ________________________________________ Number of bank account XX00 X 00000 00000 000000000000 Mail address of the beneficiary for the payments xxxxxxxxxxxxxxxx@xxxxxxxxx.xxxxxxx.xx Codice SWIFT/SWIFT code XXXXXX00X00 P. IVA/VAT no06593810481
6.8. ______________________________________
6.8 The payments made for the Entity's services (i) represent the fair market value for those services, as they reflect the tariff scale applied by the Entity, (ii) were negotiated under normal market conditions, and (iii) were not agreed on the basis of the volume or value of prescriptions or in reference to those prescriptions or other financial activities between the PartiesParties and (iv) are not lower than the regional DRG or the nomenclator or tariff schedule of the institution if any. Neither the Entity nor the Principal Investigator shall request any compensation or reimbursement from any other party in return for the activities performed or costs incurred by including the patients in the Trial, which the Sponsor/CRO Sponsor is obligated to pay for.
6.9 (If 6.9. The CRO on behalf of Sponsor will also provide patients taking part in the Trial with the possibility of reimbursement of only travel expenses with a maximum of 27€ per visit incurred in relation to each visit made to the Entity, in compliance with the provisions of applicable regulations, according to the procedures, maximum amounts and permitted expenses approved in advance by the Ethics Committee. Costs may only be reimbursed by the administration office of the Entity, which will implement its own procedures. Each patient will submit receipts for the expenses incurred in visiting the Entity; for the purposes of obtaining reimbursement from the Sponsor, the list will be anonymized by the Entity. Considering the duration of the study, the Entity will agree the terms for submission to the Sponsor of the statement of account based on the receipts for patients’ expenses presented to the Entity during the treatments carried out in the reference period. The Sponsor may check the sums claimed by comparing them against the treatments completed by the patients and will make the related payments to the Entity. It will then be the responsibility of the Entity to arrange to reimburse the sums to each patient in accordance with the amounts in the table contained in the Budget herewith attached sub A Part 1 Item NP007.). It provided for in the Protocol Protocol, may be offered a compensatory allowance for expenses and if lost earnings directly associated with participation in the legal conditions Trial, also for the careers of patients who are met)unable to travel alone, for example children, incapacitated subjects, vulnerable patients. Each patient will present the list of expenses to the Entity or to the person delegated by this, for the purposes of coverage by the Sponsor. All costs related to items not listed in Annex A will not be reimbursed. Parties agree that any bank charges AIFA National template 10-11-2022 Clinical Trial Agreement (CTA) PI Baldi V. 0.5 20 Sep 2023 and commissions due for foreign wire transfer shall be charged entirely to the originator and in no case can they be deducted from the amount that is credited to the payee.
Appears in 1 contract
Samples: Clinical Trial Agreement (Cta)
Remuneration. 6.1 The remuneration agreed agreed, previously evaluated by the Entity, for each eligible, assessable patient whose and who has completed the Trial treatment has been completed according to the Protocol and for whom the related CRF/eCRF has been duly compiled, including all the costs incurred by the Entity in execution of this Trial theTrial and the costs to cover all the related activities, is €_________ + VAT (if applicable) per € 2,306.00per patient (a total of € _______ +VAT (if applicable) 36,896.00 for ____ an estimated 16 patients) as specified in more detail in the Budget annexed in Annex A.annexed.
6.2 The Sponsor/CRO Sponsor will pay the amount due under the terms of this article on the basis of a valid statement of account/supporting document, sent by the Sponsor to the Entity and document agreed between the Parties, after Sponsor has approved the payment. CRO, as Sponsor’s payment agent, shall make payments from funds provided by Sponsor. The budget contained in Annex A is inclusive of all applicable taxes. The above amount will be paid at the intervals indicated in the Budget (Annex A), A on the basis of the number of patients enrolled during the period, the treatments carried out according to the Protocol, and in the presence of the duly completed CRF/eCRF duly compiled and validated by the Sponsor/CRO Sponsor based on the activities carried out. Upon completion or termination of this Agreement, in no event shall CRO be obligated to pay any invoices submitted after the time period for submitting final invoices set forth in the Annex A has expired. In any case, the CRO undertakes to send an invoice request to the e-mail addresses xxxxxxxxxxxxxxx@xxxxxxxxxx.xx and xxxxxxxxxxxx@xxxxxxxxxx.xx. Entity and Principal Investigator represent that neither Principal Investigator nor Entity are a citizen or resident of the United States, or a corporation or partnership that is and has been treated as a U.S. corporation or U.S. pagamenti che l'Ente riceve ai sensi del presente Contratto saranno destinati a servizi resi al di fuori degli Stati Uniti. Nel caso in cui le leggi fiscali richiedano una trattenuta, la Parte legalmente responsabile sarà responsabile per le trattenute. partnership, and that all payments Entity receives under this Agreement will be for services rendered outside the United States. Should any tax laws require withholding, the Party legally responsible shall be liable for withholdings.
(a) (where applicable6.3 Tutti gli esami di laboratorio/strumentali e ogni altra prestazione/attività aggiuntiva non compresa nel corrispettivo pattuito per paziente eleggibile, if the tests are done by a centre external to the Entity) Or
(b) (where applicablerichiesta dal Promotore, if the tests are carried out on the Entity’s premises) così come approvato dal Comitato Etico e dall’Autorità Competente e come dettagliato in Allegato A), saranno rimborsati e fatturati dal Promotore in aggiunta al corrispettivo pattuito per paziente eleggibile. 6.3 All the laboratory/instrument tests and any other services or additional activities not covered by the price agreed per eligible patient, and requested by the Sponsor as approved by the Ethics Committee and Competent Authority and as detailed in Annex A Part 2, shall Xxxxx Xxxxxx be reimbursed and invoiced by the Sponsor/CRO in addition to the price paid for each eligible patient.
6.4 L'Ente non riceverà alcun compenso per pazienti non valutabili a causa di inosservanza del Protocollo, di violazione delle norme di Buona Pratica Clinica o di mancato rispetto della normativa vigente in materia di sperimentazioni cliniche di medicinali. L'Ente non avrà diritto ad alcun compenso anche per pazienti coinvolti successivamente alla comunicazione di interruzione e/o conclusione della Sperimentazione da parte del Promotore od oltre il numero massimo di soggetti da includere ai sensi del presente Contratto, ove non concordati con il Promotore. 6.4 The Entity will not receive any remuneration for patients who cannot be assessed due to failure to observe the Protocol, violation of the rules of Good Clinical Practice or failure to comply with the laws applicable to clinical drug trials. The Entity will have no right to receive any remuneration for any patient enrolled after notification of interruption and/or conclusion of the Trial by the Sponsor/CROSponsor/, or any number beyond the maximum number of patients stipulated under the terms of this Agreement, if not agreed with the Sponsor.
6.5 (where applicable) Il Promotore provvederà, inoltre, a rimborsare all’Ente tutti i costi aggiuntivi risultanti da attività mediche/diagnostiche, compresi eventuali ricoveri, non previste nel Protocollo o nei successivi emendamenti allo stesso, e non già coperti dai compensi sopra elencati, qualora tali attività si rendano indispensabili per una corretta gestione clinica del paziente in Sperimentazione. Il rimborso sarà effettuato solo a condizione che tali attività e i relativi costi vengano tempestivamente comunicati, giustificati e documentati per iscritto al Promotore e approvati per iscritto dallo stesso, ferma restando la comunicazione in forma codificata dei dati personali del paziente. 6.5 The Sponsor/CRO Sponsor shall also reimburse the Entity (or the executor, appointed for this purpose by the Entity and in agreement with the latter) with all the additional costs of medical/diagnostic activities, including hospital admissions, which are not provided for in the Protocol or amendments to the Protocol, and which are not already covered by the above payments, if such activities are essential for the proper clinical treatment of a patient undergoing the trialTrial. The reimbursement will only be paid on condition that such activities and costs have been properly communicated, with justification, and have been documented in writing to the Sponsor/CRO Sponsor and approved in writing by the Sponsor/CRO, and provided that the obligation that any patient’s personal data is communicated in coded form (by the Entity)anonymized form.
6.6 Se nel corso dello svolgimento della Sperimentazione si rendesse necessario aumentare il supporto economico a favore dell'Ente, il Promotore/CRO potrà integrare, con un addendum/emendamento, il presente Contratto, prevedendo l'adeguato aumento del Budget qui allegato. 6.6 If, during the Trial, it is necessary to increase the financial support to the Entity, the Sponsor/CRO may supplement this Agreement Agreement, by and addendum/amendment, by authorising the appropriate increase to the attached Budget.
6.7 In ottemperanza alla normativa sull’obbligo della fatturazione elettronica per le cessioni di beni e per la prestazione di servizi anche tra privati, l’Ente emetterà fatture in formato XML (Extensible Markup Language) e trasmesse tramite il Sistema di Interscambio (SDI). 6.7 In accordance with the 2018 Budget Act (paragraph 909) requiring, within the Italian territory, regulation on mandatory e-invoicing for sales of goods and services among private individuals, the Entity shall issue invoices in XML (Extensible Markup Language) format to Italian companiesformat. Invoices are to be sent through the interchange system (SDI). Lo Sponsor/CRO comunica i dati necessari per l’emissione della fattura: The Sponsor/CRO shall provide the data necessary for the issue of the e-invoice: COMPANY NAME ______________________________ RECIPIENT CODE/CERTIFIED EMAILMedpace Clinical Research, LLC Medpace Clinical Research, LLC Attn: ________________ Tax ID ________________________________________ VAT no. ______________________________________
6.8 The payments made for the Entity's services (i) represent the fair market value for those servicesClinical Operations Site Payments Attn: Clinical Operations Site Payments 0000 Xxxxxxx Xxx 0000 Xxxxxxx Xxx Xxxxxxxxxx, as they reflect the tariff scale applied by the EntityXxxx 00000 Xxxxxxxxxx, (ii) were negotiated under normal market conditions, and (iii) were not agreed on the basis of the volume or value of prescriptions or in reference to those prescriptions or other financial activities between the Parties. Neither the Entity nor the Principal Investigator shall request any compensation or reimbursement from any other party in return for the activities performed or costs incurred by including the patients in the Trial, which the Sponsor/CRO is obligated to pay for.
6.9 (If provided for in the Protocol and if the legal conditions are met)Xxxx 00000 Email: xxxxxxxxxxxx@xxxxxxx.xxx Email: xxxxxxxxxxxx@xxxxxxx.xxx
Appears in 1 contract
Samples: Clinical Trial Agreement