Common use of Costs and Payments Clause in Contracts

Costs and Payments. Part 1 - Fixed costs and payment per patient included in the study Include, by way of example, the following items: Fixed costs for the Ethics Committee (attach copy of the bank transfer) (Coordinating centre for drug trials, satellite centre for drug trials, Amendments) Supply of the Trial Drug(s) and/or of any other materials required for the trial provided that there are no extra costs for the National Health Service (diagnostics kits, medical devices, etc.). Gross payment per patient included in the study: € _______+ VAT (include multiple payments for studies that require different payments for each “arm” of the protocol). Payment per trial Centre for each completed patient (Payment for enrolled patient - company overheads - all the costs incurred by the Entity for the trial1): € _______ + VAT. Interim financial phases (if the patients do not complete the trial procedure): Examination: payment per patient (Examination no. ____ of € ___. + VAT; Contacts € ___ + VAT; Treatment cycles € _____+ VAT; Examination no. ___ € ____. + VAT). (only include this paragraph if there are no extra costs referred to in part 2). All the reimbursable costs of the study, including those covered by the contribution per patient involved, shall not lead to any extra costs payable by the National Health Service (for example, there are no additional services, the instrumental and laboratory tests are routine for the patients in the trial, or the instrumental tests are routine for the patients in the trial and the lab tests will be carried out with diagnostic kits supplied by ____ or the lab tests will be done at a centralised external laboratory). Part 2 Additional costs for instrumental tests and/or lab tests to be carried out according to the Tariff Breakdown of additional costs (the amounts payable for the services may be updated or revised following decisions/measures taken by the region of _______ and will apply from the effective date of those decisions/measures): TARIFF CODE DESCRIPTION OF TEST NO. OF TESTS PER PATIENT AMOUNT € _____+ VAT Part 3 Reimbursement of costs for patients/carers included in the clinical trial: (if applicable) List the type of reimbursement of travel expenses including taxi/overnight accommodation/meals, upon submission of receipts or other supporting documents.

Costs and Payments. Part 1 - Fixed costs and payment per patient included in the study Include, by way of example, the following items: ‐ Fixed costs for the Ethics Committee (attach copy of the bank transfer) (Coordinating centre for drug trials, satellite centre for drug trials, Amendments) ‐ Supply of the Trial Drug(s) and/or of any other materials required for the trial provided that there are no extra costs for the National Health Service (diagnostics kits, medical devices, etc.). ‐ Gross payment per patient included in the study: € _______+ VAT (include multiple payments for studies that require different payments for each “arm” of the protocol). ‐ Payment per trial Centre for each completed patient (Payment for enrolled patient - company overheads - all the costs incurred by the Entity for the trial1): € _______ + VAT. ‐ Interim financial phases (if the patients do not complete the trial procedure): Examination: payment per patient (Examination no. ____ of € ___. + VAT; Contacts € ___ + VAT; Treatment cycles € _____+ VAT; Examination no. ___ € ____. + VAT). ‐ (only include this paragraph if there are no extra costs referred to in part 2). All the reimbursable costs of the study, including those covered by the contribution per patient involved, shall not lead to any extra costs payable by the National Health Service (for example, there are no additional services, the instrumental and laboratory tests are routine for the patients in the trial, or the instrumental tests are routine for the patients in the trial and the lab tests will be carried out with diagnostic kits supplied by ____ or the lab tests will be done at a centralised external laboratory). 1 • general admin costs, costs incurred by the Pharmacy service in managing the Trial drug(s). Part 2 Additional costs for instrumental tests and/or lab tests to be carried out according to the Tariff ‐ Breakdown of additional costs (the amounts payable for the services may be updated or revised following decisions/measures taken by the region of _______ and will apply from the effective date of those decisions/measures): ‐ TARIFF CODE ‐ DESCRIPTION OF TEST ‐ NO. OF TESTS PER PATIENT ‐ AMOUNT € _____+ VAT Part 3 Reimbursement of costs for patients/carers included in the clinical trial: (if applicable) List the type of reimbursement of travel expenses including taxi/overnight accommodation/meals, upon submission of receipts or other supporting documents.

Costs and Payments. Part 1 - Fixed costs and payment per patient included in the study enrolled Include, by way of example, the following items: - Fixed costs for the Ethics Committee (attach copy of the bank transfer) (Coordinating centre for drug trialsClinical investigation on Medical devices, satellite Satellite centre for drug trialsClinical investigation on Medical devices, Amendments) - Supply of the Trial Drug(s) Experimental medical device and/or of any other materials required for the trial Clinical investigation provided that there are no extra costs for the National Health Service (diagnostics kits, medical devices, etc.). ) - Gross payment per patient included in the studyfor enrolled patient: € _______+ VAT (include multiple payments for studies that require different payments for each “arm” of the protocol). ) - Payment per trial Investigation Centre for each completed patient (Payment for enrolled patient - company overheads - all the costs incurred by the Entity for the trial1Clinical investigation1): € _______ + VAT. - Interim financial phases (if the patients do not complete the trial procedure): Examination: payment per patient (Examination no. ____ of € ___. + VAT; Contacts € ___ + VAT; Treatment cycles € _____+ VAT; Examination no. __€ _ € ____. + VAT). ) - (only include this paragraph if there are no extra costs referred to in part 2). All the reimbursable costs of the studytrial, including those covered by the contribution per patient involved, shall not lead to any extra costs payable by the National Health Service (for example, there are no additional services, the instrumental and laboratory tests are routine for the patients in the trial, or the instrumental tests are routine for the patients in the trial and the lab tests will be carried out with diagnostic kits supplied by ____ or the lab tests will be done at a centralised external laboratory). Part 2 Additional costs for instrumental tests and/or lab tests to be carried out according to the Tariff - Breakdown of additional costs (the amounts payable for the services may be updated or revised following decisions/measures taken by the region of _______ and will apply from the effective date of those decisions/measures): 1 • general administrative costs, costs sustained for the management of the MD subject to the Clinical investigation - TARIFF CODE - DESCRIPTION OF TEST - NO. OF TESTS PER PATIENT per patient - AMOUNT € _____+ VAT Part 3 Reimbursement of costs for patients/carers included in the clinical trial: (if applicable) List the type of reimbursement of travel expenses including taxi/overnight accommodation/meals, upon submission of receipts or other supporting documents.VAT

Costs and Payments. Part 1 - Fixed costs and payment per patient included in the study Include, by way of example, the following items: - Fixed costs for the Ethics Committee (attach copy of the bank transfer) (Coordinating centre for drug trials, satellite centre for drug trials, Amendments) - Supply of the Trial Drug(s) and/or of any other materials required for the trial provided that there are no extra costs for the National Health Service (diagnostics kits, medical devices, etc.). - Gross payment per patient included in the study: € _______+ VAT (include multiple payments for studies that require different payments for each “arm” of the protocol). - Payment per trial Centre for each completed patient (Payment for enrolled patient - company overheads - all the costs incurred by the Entity for the trial1): € _______ + VAT. - Interim financial phases (if the patients do not complete the trial procedure): Examination: payment per patient (Examination no. ____ of € ___. + VAT; Contacts € ___ + VAT; Treatment cycles € _____+ VAT; Examination no. ___ € ____. + VAT). - (only include this paragraph if there are no extra costs referred to in part 2). All the reimbursable costs of the study, including those covered by the contribution per patient involved, shall not lead to any extra costs payable by the National Health Service (for example, there are no additional services, the instrumental and laboratory tests are routine for the patients in the trial, or the instrumental tests are routine for the patients in the trial and the lab tests will be carried out with diagnostic kits supplied by ____ or the lab tests will be done at a centralised external laboratory). Part 2 Additional costs for instrumental tests and/or lab tests to be carried out according to the Tariff 1 • general admin costs, costs incurred by the Pharmacy service in managing the Trial drug(s). - Breakdown of additional costs (the amounts payable for the services may be updated or revised following decisions/measures taken by the region of _______ and will apply from the effective date of those decisions/measures): - TARIFF CODE - DESCRIPTION OF TEST - NO. OF TESTS PER PATIENT - AMOUNT € _____+ VAT Part 3 Reimbursement of costs for patients/carers included in the clinical trial: (if applicable) List the type of reimbursement of travel expenses including taxi/overnight accommodation/meals, upon submission of receipts or other supporting documents.

Costs and Payments. Part 1 - Fixed costs and payment per patient included in the study Include, by way of example, the following items: ‐ Fixed costs for the Ethics Committee (attach copy of the bank transfer) (Coordinating centre for drug trials, satellite centre for drug trials, Amendments) ‐ Supply of the Trial Drug(s) and/or of any other materials required for the trial provided that there are no extra costs for the National Health Service (diagnostics kits, medical devices, etc.). ‐ Gross payment per patient included in the study: € _______+ VAT (include multiple payments for studies that require different payments for each “arm” of the protocol). ‐ Payment per trial Centre for each completed patient (Payment for enrolled patient - company overheads - all the costs incurred by the Entity for the trial1): € _______ + VAT. ‐ Interim financial phases (if the patients do not complete the trial procedure): Examination: payment per patient (Examination no. ____ of € ___. + VAT; Contacts € ___ + VAT; Treatment cycles € _____+ VAT; Examination no. ___ € ____. + VAT). ‐ (only include this paragraph if there are no extra costs referred to in part 2). All the reimbursable costs of the study, including those covered by the contribution per patient involved, shall not lead to any extra costs payable by the National Health Service (for example, there are no additional services, the instrumental and laboratory tests are routine for the patients in the trial, or the instrumental tests are routine for the patients in the trial and the lab tests will be carried out with diagnostic kits supplied by ____ or the lab tests will be done at a centralised external laboratory). Part 2 Additional costs for instrumental tests and/or lab tests to be carried out according to the Tariff 1 • general admin costs, costs incurred by the Pharmacy service in managing the Trial drug(s). ‐ Breakdown of additional costs (the amounts payable for the services may be updated or revised following decisions/measures taken by the region of _______ and will apply from the effective date of those decisions/measures): ‐ TARIFF CODE ‐ DESCRIPTION OF TEST ‐ NO. OF TESTS PER PATIENT ‐ AMOUNT € _____+ VAT Part 3 Reimbursement of costs for patients/carers included in the clinical trial: (if applicable) List the type of reimbursement of travel expenses including taxi/overnight accommodation/meals, upon submission of receipts or other supporting documents.

Costs and Payments. Part 1 - Fixed costs and payment per patient included in the study Include, by way of example, the following items: ‐ Fixed costs for the Ethics Committee (attach copy of the bank transfer) (Coordinating centre for drug trials, satellite centre for drug trials, Amendments) ‐ Supply of the Trial Drug(s) and/or of any other materials required for the trial provided that there are no extra costs for the National Health Service (diagnostics kits, medical devices, etc.). ‐ Gross payment per patient included in the study: € _______+ VAT (include multiple payments for studies that require different payments for each “arm” of the protocol). ‐ Payment per trial Centre for each completed patient (Payment for enrolled patient - company overheads - all the costs incurred by the Entity for the trial1): € _______ + VAT. ‐ Interim financial phases (if the patients do not complete the trial procedure): Examination: payment per patient (Examination no. ____ no of € ___. + VAT; Contacts € ___ + VAT; Treatment cycles € ______ + VAT; Examination no. ___ € ____. + VAT). ‐ (only include this paragraph if there are no extra costs referred to in part 2). All the reimbursable costs of the study, including those covered by the contribution per patient involved, shall not lead to any extra costs payable by the National Health Service (for example, there are no additional services, the instrumental and laboratory tests are routine for the patients in the trial, or the instrumental tests are routine for the patients in the trial and the lab tests will be carried out with diagnostic kits supplied by ____ or the lab tests will be done at a centralised external laboratory). 1 • general admin costs, costs incurred by the Pharmacy service in managing the Trial drug(s). Part 2 Additional costs for instrumental tests and/or lab tests to be carried out according to the Tariff ‐ Breakdown of additional costs (the amounts payable for the services may be updated or revised following decisions/measures taken by the region of _______ _ and will apply from the effective date of those decisions/measures): ‐ TARIFF CODE ‐ DESCRIPTION OF TEST ‐ NO. OF TESTS PER PATIENT ‐ AMOUNT € _____+ VAT Part 3 Reimbursement of costs for patients/carers included in the clinical trial: (if applicable) List the type of reimbursement of travel expenses including taxi/overnight accommodation/meals, upon submission of receipts or other supporting documents.

Costs and Payments. Part 1 - Fixed costs and payment per patient included in the study enrolled Include, by way of example, the following items: ‐ Fixed costs for the Ethics Committee (attach copy of the bank transfer) (Coordinating centre for drug trialsClinical investigation on Medical devices, satellite Satellite centre for drug trialsClinical investigation on Medical devices, Amendments) ‐ Supply of the Trial Drug(s) Experimental medical device and/or of any other materials required for the trial Clinical investigation provided that there are no extra costs for the National Health Service (diagnostics kits, medical devices, etc.). ) ‐ Gross payment per patient included in the studyfor enrolled patient: € _______+ VAT (include multiple payments for studies that require different payments for each “arm” of the protocol). ) ‐ Payment per trial Investigation Centre for each completed patient (Payment for enrolled patient - company overheads - all the costs incurred by the Entity for the trial1Clinical investigation1): € _______ + VAT. ‐ Interim financial phases (if the patients do not complete the trial procedure): Examination: payment per patient (Examination no. ____ of € ___. + VAT; Contacts € ___ + VAT; Treatment cycles € _____+ VAT; Examination no. ___ € ____. + VAT). ) ‐ (only include this paragraph if there are no extra costs referred to in part 2). All the reimbursable costs of the studytrial, including those covered by the contribution per patient involved, shall not lead to any extra costs payable by the National Health Service (for example, there are no additional services, the instrumental and laboratory tests are routine for the patients in the trial, or the instrumental tests are routine for the patients in the trial and the lab tests will be carried out with diagnostic kits supplied by ____ or the lab tests will be done at a centralised external laboratory). Part 2 Additional costs for instrumental tests and/or lab tests to be carried out according to the Tariff ‐ Breakdown of additional costs (the amounts payable for the services may be updated or revised following decisions/measures taken by the region of _______ and will apply from the effective date of those decisions/measures): TARIFF CODE DESCRIPTION OF TEST NO. OF TESTS PER PATIENT AMOUNT € _____+ VAT Part 3 Reimbursement of costs for patients/carers included in the clinical trial: (if applicable) List the type of reimbursement of travel expenses including taxi/overnight accommodation/meals, upon submission of receipts or other supporting documents.):

Costs and Payments. Part 1 - Fixed costs and payment per patient included in the study enrolled Include, by way of example, the following items: Fixed costs for the Ethics Committee (attach copy of the bank transfer) (Coordinating centre for drug trialsClinical investigation on Medical devices, satellite Satellite centre for drug trialsClinical investigation on Medical devices, Amendments) Supply of the Trial Drug(s) Experimental medical device and/or of any other materials required for the trial Clinical investigation provided that there are no extra costs for the National Health Service (diagnostics kits, medical devices, etc.). ) Gross payment per patient included in the studyfor enrolled patient: € _______+ VAT (include multiple payments for studies that require different payments for each “arm” of the protocol). ) Payment per trial Investigation Centre for each completed patient (Payment for enrolled patient - company overheads - all the costs incurred by the Entity for the trial1Clinical investigation1): € _______ + VAT. Interim financial phases (if the patients do not complete the trial procedure): Examination: payment per patient (Examination no. ____ of € ___. _ + VAT; Contacts € ___ + VAT; Treatment cycles € ______ + VAT; Examination no. _.__ € ____. _ + VAT). ) (only include this paragraph if there are no extra costs referred to in part 2). All the reimbursable costs of the studytrial, including those covered by the contribution per patient involved, shall not lead to any extra costs payable by the National Health Service (for example, there are no additional services, the instrumental and laboratory tests are routine for the patients in the trial, or the instrumental tests are routine for the patients in the trial and the lab tests will be carried out with diagnostic kits supplied by ____ or the lab tests will be done at a centralised external laboratory). Part 2 Additional costs for instrumental tests and/or lab tests to be carried out according to the Tariff Breakdown of additional costs (the amounts payable for the services may be updated or revised following decisions/measures taken by the region of _____________ and will apply from the effective date of those decisions/measures): TARIFF CODE DESCRIPTION OF TEST NO. OF TESTS PER PATIENT per patient AMOUNT € _____+ VAT Alternatively Declaration (with related justification) stating that the trial shall not lead to any extra costs payable by the National Health Service (for example, the instrumental and laboratory tests are routine for the patients in the trial, or the instrumental tests are routine for the patients in the trial and the lab tests will be carried out with diagnostic kits supplied by _________________ or the lab tests will be done at a centralised external laboratory _________________). Part 3 Reimbursement of costs for patients/carers included in the clinical trialClinical investigation: (if applicable) List the type of reimbursement of travel expenses including taxi/overnight accommodation/meals, upon submission of receipts or other supporting documents.