Common use of Medical devices and Materials Clause in Contracts

Medical devices and Materials. 4.1 The Sponsor shall provide the Entity, free of charge and for the duration of the Trial, with the necessary and sufficient quantities of the medical devices relating to the Trial (_____) (the “Trial Devices”) of class _____ and shall provide any other materials necessary for the execution of the Trial (the “Materials”). In case of clinical trials carried out with Trial Devices bearing the CE marking, the additional costs with respect to normal clinical practice, deriving from the application of this paragraph, are borne by the manufacturer. The Trial Devices required for clinical trials, which have not already been acquired in compliance with the ordinary procedures for the supply of goods, are also borne by the manufacturer. The quantities of Trial Devices for Clinical Trials must be adequate for the number of cases treated. 4.2 The Trial Devices shall be sent by the Sponsor/CRO to the Pharmacy of the Entity, which will record them, store them appropriately and deliver them to the Principal Investigator in accordance with the provisions of the Protocol and the current regulations. 4.3 The Trial Devices shall be accompanied by an adequate transport note addressed to the Pharmacy, describing the type of device, the quantity, batch, storage requirements, expiry date and references to the Trial (Protocol code, Principal Investigator, and Trial Centre). 4.4 The Entity and the Principal Investigator shall use the Trial Devices and Materials supplied by the Sponsor exclusively in the context of, and to conduct the Trial. The Entity shall not transfer or assign to a third party the Trial Devices and Materials supplied by the Sponsor under the terms of this Agreement. 4.5 All the expired or otherwise unusable Trial Devices or those that have not been used on conclusion of the Trial will be collected by the Sponsor (or its representative). (c) In the case of observational studies on drugs