Common use of Loan for use Clause in Contracts

Loan for use. (where applicable) 5.1. The Sponsor grants on gratuitous loan to the Entity, which accepts pursuant to and for the purposes of articles 1803 et seq. of the Italian Civil Code, the Instruments described below, together with the relevant material for use (hereinafter cumulatively the “Instrument”) ________ (description of the asset and corresponding value in Euro). The ownership of the Instrument, as by law, is not transferred to the Entity. The effects of this loan shall commence from the date of delivery of the Instruments and shall cease at the end of the Trial, when the Instruments shall be returned to the Sponsor at no cost to the Entity. The Parties also agree that any additional Instruments deemed necessary for the conduct of the study during the course of the Trial, should the characteristics and conditions thereof be met, shall be granted on gratuitous loan for use in accordance with the provisions of this Agreement. The Entity and the Sponsor shall proceed with a specific loan agreement, or with an addendum/amendment to the Agreement, if the Instruments are provided after the conclusion of the present Agreement. 5.2. It is required that the Instruments supplied have such characteristics, and in particular are configured to comply with the following requirements: • physical encryption of hard disks or, where this is not possible, provision of the device for • remote locking and logical encryption of files; • installation of antivirus with an active licence; • access to the Instruments via password authentication; • operating system with active support for updates/patches. The Instruments in question must be provided with a declaration of conformity with European standards and directives. The Instrument(s) in question will be subjected to acceptance testing if the instrument has direct action on the patient or on other machinery present in the Entity by the technicians appointed by the Entity, in the presence of a delegate of the Sponsor, subject to prior agreement, for verification of correct installation and functionality and compliance with current regulations. At the time of delivery of the materials supplied on loan for use by the Sponsor to the Entity, suitable documentation shall be drawn up to certify the delivery. 5.3. The Sponsor shall be responsible for the transport and installation of the Instruments and undertakes to provide, at its own expense, the technical assistance necessary for its operation as well as any consumables for its use, at no cost to the Entity. 5.4. In accordance with the provisions of the technical manual of the Instrument, the Sponsor will carry out, at its own expense, in cooperation with the Investigator, all the technical interventions necessary for the proper functioning of the Equipment, such as quality controls, calibrations and periodic safety checks. In the event of malfunction or failure of the Equipment, promptly communicated by the Investigator, the Sponsor will proceed, directly or through specialised personnel, with corrective maintenance or repair or replacement with a similar Equipment. 5.5. The Sponsor shall bear all burden and liability in relation to any damage that may be caused to persons or things in connection with the use of the equipment in question according to the indications of the Protocol and the manufacturer's instructions, if due to a defect of the same, except in the case where such damage is caused by willful misconduct and/or gross negligence on the part of the Entity. To this end, a plate or other suitable indication of ownership shall be affixed to the Instruments. 5.6. The Instruments shall be used by the Institution's staff and/or patients and for the sole and exclusive purposes of the Trial object of this Agreement, in accordance with the provisions of the Protocol. The Institution undertakes to keep and store the Instruments appropriately and with the necessary care, not to use it/them for any other use than the one envisaged above, not to transfer even temporarily the use of the Instruments to third parties, be it free of charge or for a consideration, and to return the Instruments to the Sponsor in the state in which it/they were delivered to the Entity, except for normal deterioration due to the effect of use. 5.7. The Sponsor reserves the right to demand the immediate return of the Instruments if the Instruments are used improperly or otherwise in a manner inconsistent with the provisions of this Agreement. 5.8. in the event of theft or loss of the Instruments, the Entity shall promptly, upon knowledge of the event, file a formal complaint with the competent public authority and notify the Sponsor within the same time limit. In all other cases of damage or destruction, the Entity shall notify the Sponsor promptly after knowledge of the event. Any fraudulent or otherwise unauthorized use must be reported immediately by the Principal Investigator to the Sponsor. In the event of irreparable damage or theft of the Instruments, the Sponsor shall replace the Instruments, at no cost to the Entity, unless the event is the result of willful misconduct on the part of the Entity. 5.9. It is understood that with regard to the Instruments that will be directly handled or managed by the patients/parents/legal guardians (e.g., electronic diaries), the Sponsor acknowledges that the Entity is relieved from any responsibility deriving from tampering, damage or theft of the same Instruments attributable to the patients/parents/legal guardians. In the event of failure and/or loss by the subjects participating in the study, the Sponsor will replace the equipment at its own expense; the Entity will be responsible for the delivery of the equipment to the recipient, including the registration and delivery of the Sponsor's instructions, as well as the collection at the time of the subject's exit, for whatever reason, from the study; the Entity will also be responsible for promptly informing the Sponsor of any failure to return the equipment by the subjects participating in the study. 5.10. Authorisation for the free loan of the Instruments was granted by the Entity following its internal procedures.

Loan for use. (where applicable) 5.1. The Sponsor grants on gratuitous loan to the Entity, which accepts pursuant to and for the purposes of articles 1803 et seq. of the Italian Civil Code, the Instruments described below, together with the relevant material for use (hereinafter cumulatively the “Instrument”) ________ (description of the asset and corresponding value in Euro). The ownership of the Instrument, as by law, is not transferred to the Entity. The effects of this loan shall commence from the date of delivery of the Instruments and shall cease at the end of the Trial, when the Instruments shall be returned to the Sponsor at no cost to the Entity. The Parties also agree that any additional Instruments deemed necessary for the conduct of the study during the course of the Trial, should the characteristics and conditions thereof be met, shall be granted on gratuitous loan for use in accordance with the provisions of this Agreement. The Entity and the Sponsor shall proceed with a specific loan agreement, or with an addendum/amendment to the Agreement, if the Instruments are provided after the conclusion of the present Agreement.and 5.2. It is required that the Instruments supplied have such characteristics, and in particular are configured to comply with the following requirements: • physical encryption of hard disks or, where this is not possible, provision of the device for • remote locking and logical encryption of files; • installation of antivirus with an active licence; • access to the Instruments via password authentication; • operating system with active support for updates/patches. The Instruments in question must be provided with a declaration of conformity with European standards and directives. The Instrument(s) in question will be subjected to acceptance testing if the instrument has direct action on the patient or on other machinery present in the Entity by the technicians appointed by the Entity, in the presence of a delegate of the Sponsor, subject to prior agreement, for verification of correct installation and functionality and compliance with current regulations. At the time of delivery of the materials supplied on loan for use by the Sponsor to the Entity, suitable documentation shall be drawn up to certify the delivery. 5.3. The Sponsor shall be responsible for the transport and installation of the Instruments and undertakes to provide, at its own expense, the technical assistance necessary for its operation as well as any consumables for its use, at no cost to the Entity. 5.4. In accordance with the provisions of the technical manual of the Instrument, the Sponsor will carry out, at its own expense, in cooperation with the Investigator, all the technical interventions necessary for the proper functioning of the Equipment, such as quality controls, calibrations and periodic safety checks. In the event of malfunction or failure of the Equipment, promptly communicated by the Investigator, the Sponsor will proceed, directly or through specialised personnel, with corrective maintenance or repair or replacement with a similar Equipment. 5.5. The Sponsor shall bear all burden and liability in relation to any damage that may be caused to persons or things in connection with the use of the equipment in question according to the indications of the Protocol and the manufacturer's instructions, if due to a defect of the same, except in the case where such damage is caused by willful misconduct and/or gross negligence on the part of the Entity. To this end, a plate or other suitable indication of ownership shall be affixed to the Instruments. 5.6. The Instruments shall be used by the Institution's staff and/or patients and for the sole and exclusive purposes of the Trial object of this Agreement, in accordance with the provisions of the Protocol. The Institution undertakes to keep and store the Instruments appropriately and with the necessary care, not to use it/them for any other use than the one envisaged above, not to transfer even temporarily the use of the Instruments to third parties, be it free of charge or for a consideration, and to return the Instruments to the Sponsor in the state in which it/they were delivered to the Entity, except for normal deterioration due to the effect of use. 5.7. The Sponsor reserves the right to demand the immediate return of the Instruments if the Instruments are used improperly or otherwise in a manner inconsistent with the provisions of this Agreement. 5.8. in the event of theft or loss of the Instruments, the Entity shall promptly, upon knowledge of the event, file a formal complaint with the competent public authority and notify the Sponsor within the same time limit. In all other cases of damage or destruction, the Entity shall notify the Sponsor promptly after knowledge of the event. Any fraudulent or otherwise unauthorized use must be reported immediately by the Principal Investigator to the Sponsor. In the event of irreparable damage or theft of the Instruments, the Sponsor shall replace the Instruments, at no cost to the Entity, unless the event is the result of willful misconduct on the part of the Entity. 5.9. It is understood that with regard to the Instruments that will be directly handled or managed by the patients/parents/legal guardians (e.g., electronic diaries), the Sponsor acknowledges that the Entity is relieved from any responsibility deriving from tampering, damage or theft of the same Instruments attributable to the patients/parents/legal guardians. In the event of failure and/or loss by the subjects participating in the study, the Sponsor will replace the equipment at its own expense; the Entity will be responsible for the delivery of the equipment to the recipient, including the registration and delivery of the Sponsor's instructions, as well as the collection at the time of the subject's exit, for whatever reason, from the study; the Entity will also be responsible for promptly informing the Sponsor of any failure to return the equipment by the subjects participating in the study. 5.10. Authorisation for the free loan of the Instruments was granted by the Entity following its internal procedures.