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: ▇▇▇▇▇▇▇▇▇▇▇.▇▇▇▇@▇▇▇▇▇.▇▇▇▇▇▇.▇▇▇ 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 ▇▇▇▇▇▇▇▇▇▇▇.▇▇▇▇@▇▇▇▇▇.▇▇▇▇▇▇.▇▇▇ 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: ▇▇▇▇▇ ▇▇ ▇▇ ▇▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇ ▇▇▇▇▇-▇▇▇▇▇▇ Account Nº/IBAN: ▇▇▇▇ ▇▇▇▇ ▇▇▇▇ ▇▇▇▇ ▇▇▇▇ ▇▇▇▇ SWIFT CODE: CAIXE SBBxxx VAT number /Tax ID CODE: ▇-▇▇▇▇▇▇▇▇ 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.
Accounting and Financial Determinations Unless otherwise specified, all accounting terms used herein shall be interpreted, all accounting determinations and computations hereunder or thereunder (including under Clause 9.4 (Financial Condition)) shall be made, and all financial statements required to be delivered hereunder or thereunder shall be prepared, in accordance with GAAP consistently applied (or, if not consistently applied, accompanied by details of the inconsistencies); provided that if the Borrower elects to apply or is required to apply IFRS accounting principles in lieu of GAAP, upon any such election and notice to the Facility Agent, references herein to GAAP shall thereafter be construed to mean IFRS (except as otherwise provided in this Agreement); provided further that if, as a result of (a) any change in GAAP or IFRS or in the interpretation thereof or (b) the application by the Borrower of IFRS in lieu of GAAP, in each case, after the date of any financial statements referred to in Clause 8.1 (Financial Information, Reports, Notices, etc.), there is a change in the manner of determining any of the items referred to herein or thereunder that are to be determined by reference to GAAP, and the effect of such change would (in the reasonable opinion of the Borrower or the Facility Agent) be such as to affect the basis or efficacy of the financial covenants contained in Clause 9.4 (Financial Condition) in ascertaining the consolidated financial condition of the Borrower and its Subsidiaries and the Borrower notifies the Facility Agent that the Borrower requests an amendment to any provision hereof to eliminate such change occurring after the date hereof in GAAP or the application thereof on the operation of such provision (or if the Facility Agent notifies the Borrower that the Required Lenders request an amendment to any provision hereof for such purpose), then such item shall for the purposes of Clause 9.4 (Financial Condition) continue to be determined in accordance with GAAP relating thereto as if GAAP were applied immediately prior to such change in GAAP or in the interpretation thereof until such notice shall have been withdrawn or such provision amended in accordance herewith. Notwithstanding the foregoing, all obligations of any person that are or would be characterized as operating lease obligations in accordance with GAAP on the B34 Facility Amendment Date (whether or not such operating lease obligations were in effect on such date) shall continue to be accounted for as operating lease obligations for the purposes of this Agreement regardless of any change in GAAP following the B34 Facility Amendment Date that would otherwise require such obligations to be recharacterized (on a prospective or retroactive basis or otherwise) as capital leases.