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.
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Study Device. Company shall provide General, at no charge, with quantities of the Study Device required for the Study. The General and Principal Investigator shall safeguard such Study Device with the degree of care used for its own property. Upon completion or termination of the Study and upon Company's request, General shall return or otherwise dispose of any remaining Study Device in accordance with Company's instructions. General and Principal Investigator shall not use any Study Device for any purpose other than the Study, unless otherwise agreed.
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Study Device inclusive of all delivery systems and accessories (the “Study Device”).
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Study Device. The Study Device shall only be used as described in the Protocol and in compliance with Applicable Laws. The Institution shall maintain complete and accurate records relating to the disposition of the Study Device supplied to the Institution as set forth in Section 10.1.
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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.
Sample 1
Study Device. Sponsor agrees to timely provide, at no cost, sufficient quantities of   (“Study Device”) to conduct the Study in accordance with the Protocol.
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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.
Sample 1
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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.
Sample 1

Related to Study Device

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

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  • Tests and Preclinical and Clinical Trials The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the General Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, the Company is not aware of any studies, tests or trials, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, the Company has not received any notices or correspondence from the FDA or any Governmental Entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

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  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

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