Study Device Sample Clauses

Study Device. The Study Device shall only be used as described in the applicable Protocol and in compliance with Applicable Laws, including those pertaining to Investigational Device Exemptions. The parties acknowledge that the Study Device has not been cleared or approved by the FDA for the indication under investigation in the Study. SPONSOR is the regulatory sponsor for the Study and agrees that it has complied with all applicable laws and regulations, including filing of any required Investigational Device Exemption. The Institution shall maintain complete and accurate records relating to the storage, inventory, and disposition of the Study Device supplied to the Institution, as set forth in Section 11.1.

Study Device inclusive of all delivery systems and accessories (the “Study Device”).

Study Device. The parties understand and agree that Sponsor is and shall at all times remain the sole owner of the Study Device. Institution shall maintain control of the Study Device in accordance with applicable laws and regulations and in the manner outlined in the Protocol. Institution and Investigator shall use the Study Device for the purpose of conducting the Study in strict accordance with the Protocol and for no other purpose, and shall not transfer the Study Device to any third parties. Institution will maintain, or cause Investigator to maintain, records on the receipt, use and disposition of all Study Device, including dates, quantity and use by subjects. Investigator shall ensure the safe receipt, handling, storage and use of the Study Device and take all reasonable measures to ensure that it is kept secure. Investigator shall also keep full and accurate records of who dispenses the Study Device, the quantity dispensed and the quantity returned. Upon any termination of this Agreement, Investigator shall return any remaining quantities of the Study Device to Sponsor or its designee on behalf of Foundation at the reasonable cost of Foundation. If any quantity of the Study Device is lost, damaged, or destroyed while at the Study Location, Institution shall promptly provide Sponsor and Foundation with appropriate documentation as to the occurrence. Institution shall use its best efforts to ensure that the Study Schedule is not delayed as a result of such loss, damage, or destruction of the Study Device.

Study Device. 2.1 For any Company Study Device to be used or tested in the Study, Company agrees to supply Institution with sufficient supplies of Company Study Device, free of charge, to complete the Study as contemplated by the Protocol. Institution shall hold, store and transport all supplies of Company Study Device in compliance with all applicable federal, state and local statutes and regulations. Institution shall not use Company Study Device supplied by Company except as specified in the Protocol. Institution shall return to Company all unused supplies of Company Study Device, which are owned by Company, at Company’s expense or, with Company’s prior written authorization, may keep or destroy unused Company Study Device in accordance with Institution’s standard procedures. In the latter circumstance, Institution shall certify the completion of destruction in accordance with Institution’s procedures and all federal, state and local statutes and regulations and provide documentation of such destruction to Company. 2.2 Institution recognizes that the Company Study Device is a prototype. Company represents and warrants that it has disclosed to Institution all relevant and/or material information concerning the safety, use, and efficacy of the Company Study Device of which it is aware, and that the Company Study Device has been manufactured in accordance with all good manufacturing practices and applicable industry practices.

Study Device. Sponsor agrees to timely provide, at no cost, sufficient quantities of   (“Study Device”) to conduct the Study in accordance with the Protocol.

Study Device. The Study Device for this Clinical Trial is which does/does not have FDA approval. SPONSOR shall provide STANFORD a sufficient number of Study Devices to conduct the Clinical Trial, as well as any other compounds, materials, equipment, and information which the Protocol specifies SPONSOR will deliver or which SPONSOR deems necessary to conduct the Clinical Trial. All such Study Devices, compounds, materials, and equipment are the sole property of SPONSOR. SPONSOR shall provide STANFORD with X number of Study Devices at the beginning of the Clinical Trial or STANFORD shall issue a Purchase Order for each device which will be reimbursed at $ per Study Device. Study Devices will be shipped at SPONSOR’s expense FOB destination. SPONSOR shall promptly replace or repair any Study Device which is outdated or not in proper working condition. If insurance or a third party payer does not cover the cost of the Study Device, the SPONSOR shall reimburse STANFORD the cost of the device paid by STANFORD.