Study Drug Sample Clauses

Study Drug. Biological Samples. 12. Hodnocený přípravek. Biologické vzorky. A. CRO or another duly authorized agent of Sponsor, shall make commercially reasonable efforts to supply Institution or Investigator with sufficient quantities of the Study Drug in a timely manner, at Sponsor’s expense. All above mentioned drugs/medication supplied by Sponsor will be used solely in accordance with the Protocol and may not be used for any other purposes. Pursuant to Applicable Law, the Study Drug will be stored at the Institution’s pharmacy, which undertakes to comply with A. CRO nebo jiný řádně zmocněný zástupce zadavatele vyvinou z obchodního hlediska přiměřené úsilí, aby včas poskytli zdravotnickému zařízení nebo zkoušejícímu dostatečné množství hodnoceného přípravku, a to na náklady zadavatele. Všechny výše uvedené přípravky/léčiva, které dodá zadavatel, budou používány pouze v souladu s protokolem a nesmí být používány pro žádné jiné účely. Hodnocený přípravek bude v souladu s platnými právními předpisy uskladněn v lékárně zdravotnického the conditions of good pharmaceutical practice and related instructions of the State Institute for Drug Control and guarantees that the drug is handled only by authorised persons. The Institution pharmacy shall be responsible for accepting the Study Drug shipment and dispensing the Study Drug to the Investigator or a person authorised by him. Responsible pharmacists: Tel.: E‐mail: Back‐up pharmacist (to be added into cc): zařízení, která se zavazuje dodržovat podmínky správné lékárenské praxe a související pokyny Státního ústavu pro kontrolu léčiv a zaručuje, že s léčivým přípravkem budou manipulovat pouze oprávněné osoby. Lékárna zdravotnického zařízení bude odpovídat za příjem zásilky hodnoceného přípravku a výdej hodnoceného přípravku zkoušejícímu nebo jím pověřené osobě. Odpovědný lékárník: Tel.:

Study Drug. Company agrees that it will provide Group (indirectly through NCI) with the quantities of the Company’s investigational drug product entinostat and placebo (the “Study Drug”) required to conduct the Study in accordance with the Protocol, at no charge. Group shall use, and will ensure that Study Personnel (as defined in Section 4.D) use, the Study Drug solely for purposes of the Study in accordance with the Protocol. In handling, storing and using Study Drug, Group members will comply with all applicable laws and any written instructions provided by Company (or by NCI on behalf of Company). All Study Drug supplied to Group members will remain the exclusive property of Company until administered or dispensed to any of the patients involved in the Study (“Study Subjects”) during the course of the Study. Group members will keep the Study Drug in a safe and secure location and maintain complete and accurate records showing disposition of the Study Drug. Group members will not provide access to Study Drug to anyone except Study Personnel. Group will not chemically, physically or otherwise modify Study Drug.

Study Drug a) Institution and Investigator will be provided with sufficient amounts of the Study Drug solely for the purposes of the conduct of the Study, free of charge. Available information on the Study Drug, which Xxxxxxx considers výzkumného personálu pro sběr, zpracování, ukládání a přenos jejich osobních údajů pro výše uvedené účely.

Study Drug. (a) The Protocol is to be performed with (“Study Drug”). MedImmune will make Study Drug available to Institution, as further specified under item (d) below, at no cost or expense to the Institution or Investigator. Where applicable national laws exclude the provision of any Study Materials by MedImmune to the Institution and Investigator free of charge, the Parties shall consult to arrive at a suitable arrangement as to the supply of the Study Drug by MedImmune to the Institution. After MedImmune has: (i) received a copy of the approval of the Protocol from the relevant ethics authority of Institution, including the approved subject informed consent form; (ii) received a copy of the authorization to disclose individually identifiable health information, as applicable; (iii) received a financial disclosure form (iv) received other essential Study documents as needed; and

Study Drug. The Study Drug for this Clinical Trial -------------------- for which an application to conduct clinical trial has been filed with DCGI, and seeking for approval.

Study Drug administration and/or any patient participation in any Study or Project Exhibit may be terminated, in whole or in part, by Corcept immediately upon written notice to Scirex, if any of the following conditions occur: (a) authorization and approval to perform the Study is withdrawn by the governing regulatory body; (b) animal, human and/or toxicological test results, in the opinion of Corcept, support termination of the Study; or (c) in consideration of patient safety and welfare.

Study Drug. (a) The Protocol is to be performed with XXXXX (“Study Drug”). MedImmune will make Study Drug available to Institution, as further specified under item (d) below, at no cost or expense to the Institution or Investigator. Where applicable national laws exclude the provision of any Study Materials by MedImmune to the Institution and Investigator free of charge, the Parties shall consult to arrive at a suitable arrangement as to the supply of the Study Drug by MedImmune to the Institution. After MedImmune has: (i) received a copy of the approval of the Protocol from the relevant ethics authority of Institution, including the approved subject informed consent form; (ii) received a copy of the authorization to disclose individually identifiable health information, as applicable; (iii) received a financial disclosure form (iv) received other essential Study documents as needed; and (v) Institution has been qualified to conduct the Study by MedImmune and or its designated representative; the Study Drug will be shipped to the Institution / Pharmacy, as defined in item (d) below and will be managed by the Investigator and delegated pharmacist, as defined in item (d) below, or their qualified designee according to the Protocol. Institution may not charge any Study Subject, nor charge or seek reimbursement from any person or entity, including insurance companies, any third party payer (whether public or private) or Institution representatives, for the Study Drug (including comparator or placebo) provided by MedImmune or the administration of such Study Drug. (b) Institution and Investigator will use the Study Drug solely for the purpose of conducting the Study in accordance with the Protocol. Upon completion of the Study or at the request of MedImmune or its designated representative, Institution and/or Investigator will promptly destroy or return, at MedImmune’s expense, all unused Study Drug to MedImmune and/or its designated representatives and provide documentation, upon request by MedImmune and/or its designated representatives, certifying the destruction or return of such Study Drug.

Study Drug. Sponsor makes no representations or warranties, expressed or implied, related to the Study Drug and/or Study Device, including without limitation, any warranty or merchantability for fitness for a particular purpose, or non-infringement.

Study Drug. (a) Institution and Investigator will be provided with sufficient amounts of the Study Drug solely for the purposes of přenos jejich osobních údajů pro výše uvedené účely.

Study Drug a. AIM will furnish an agreed upon number of vials of Study Drug, approximately *** vials, *** to the Institution pursuant to this Agreement solely for use in the Protocol. *** b. Institution will store, handle and administer Study Drug under adequately controlled conditions and in accordance with the Protocol, and Study Drug information provided by AIM. c. Institution will return or destroy Study Drug in accordance with written directions of AIM and with Institution’s drug destruction policies. The Study Drug delivered pursuant to this Agreement shall not be sold, distributed or otherwise made available by the Institution to any other party for any other purpose, without the written consent of AIM, which written consent shall not be unreasonably withheld. d. Institution will not bxxx any Study subject or any third parties for any service or activity that is funded in accordance with this Agreement or any Study Drug that is supplied by AIM under this Agreement. e. The Parties acknowledge that the Study Drug is being provided “as is,” without any warranties or representations of any sort, express or implied, including without limitation warranties of merchantability and fitness for a particular use. AIM makes no representation and provides no ‘warranty that the use of the Study Drug in the Study will not infringe any patent or other proprietary right of third parties.