Study Supplies Sample Clauses

Study Supplies. Předpokládá se, že Hlavní zkoušející do Studie zařadí všechny subjekty, které se účastnily Hlavní studie (PRV-031-001, PROTECT). Podrobná kritéria pro zařazování subjektů do Studie jsou uvedena v Protokolu.
Study Supplies. ABBOTT shall provide INSTITUTION with sufficient quantity of Study Product and CRFs to conduct each Study, as well as any other compounds, materials and information which the Protocol specifies or other materials as ABBOTT deems necessary to conduct the Study at no cost solely for use by INSTITUTION and Principal Investigator in the conduct of the applicable Study. Neither INSTITUTION nor Principal Investigator will use any of the Study Product, CRFs or any other compounds, materials and information provided by ABBOTT for any purpose other than to conduct the applicable Study pursuant to the Protocol under the applicable Statement of Work. All such Study Product, CRFs and other information provided by ABBOTT in connection with this Master Agreement are and will remain the sole property of ABBOTT. INSTITUTION represents and certifies that for each Study during the Study Term, it will and will require each Principal Investigator to ensure that: (a) the supply of Study Product is adequate and that the Study Product will be stored and handled in accordance with ▇▇▇▇▇▇’▇ written instructions and as set forth in the labeling of the applicable Study Product and in accordance with applicable regulatory requirement(s); (b) the Study Product will not be used past the labeled expiration date; and (c) upon conclusion of a Study or termination of a Statement of Work or at ▇▇▇▇▇▇’▇ request, any remaining or expired Study Product, CRFs, as well as any other Study compounds, Study materials and Study information provided by ABBOTT under the applicable Statement of Work will be returned to ABBOTT, at ▇▇▇▇▇▇’▇ expense, in accordance with the Protocol and in compliance with applicable requirements governing the shipment of such Study Product or will be disposed of pursuant to the Protocol, and any local, state and federal laws and regulations governing the disposal of such Study Product, CRFs or any other Study compounds, Study materials and Study information. For Study Product, CRFs or other Study compounds, Study materials and Study information disposed by or on behalf of INSTITUTION, INSTITUTION represents and certifies that it has the necessary facilities, expertise and regulatory approvals required to dispose such Study Product, CRFs and other Study compounds, Study materials and Study information and that such disposal will be at INSTITUTION’s expense. INSTITUTION will document such return or disposal of such Study Product, CRFs, any other Study compounds, Study materi...
Study Supplies. (a) SPONSOR shall provide PAREXEL with a sufficient quantity of the Study Drug to conduct the Study, as well as any other compounds, materials and information which the Protocol specifies SPONSOR shall deliver or which SPONSOR deems necessary to conduct the Study in accordance with the Protocol (all such items, “Study Materials”). (b) All Study Drug, and Study Materials are and shall remain the sole property of SPONSOR. PAREXEL, the Principal Investigator and each Subinvestigator shall take all reasonable steps to handle, store, use and dispose of the Study Drug and any Study Materials in accordance with the Protocol. PAREXEL, the Principal Investigator and each Subinvestigator shall not release any Study Drug to any third party, with the exception of Study subjects, (including without limitation any governmental agency, any other investigator or any other third party) without the prior written express approval from SPONSOR, except in cases where they are required by law to release the Study Drug to a regulatory agency acting within the scope of its regulatory authority, in which case, PAREXEL, and the Principal Investigator/Subinvestigator will promptly notify SPONSOR of such action.