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 Sponsor considers necessary or useful for conducting the Study, will also be provided. 7. STUDIJNÍ LÉK (a) Zdravotnickému zařízení a Zkoušejícímu bude bezplatně poskytnuto dostatečné množství Studijního léku, a to výhradně pro účely provádění Studie. Rovněž budou poskytnuty dostupné informace o Studijním léku, které Zadavatel považuje za nutné nebo užitečné pro provádění Studie.
Study Drug. 1) Study Drug is an exclusive property of the Sponsor. The Principal Investigator and Institution shall use the Study Drug only to conduct the Study in accordance with the Protocol, and for no other purpose.
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:
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. ***
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. (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. (c) In the event that MedImmune determines that the Study Drug must be recalled for safety, identity, purity, strength, quality or other concerns, MedImmune will issue a notice to the Institution specifying that there is a recall. Such notice will contain instructions for how to pack and ship the Study Drug and instructions for completing necessary paperwork including accountabilit...
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. (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) 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 Sponsor considers necessary or useful for conducting the Study, will also be provided. (b) Institution agrees to limit access to the Study Drug to only Research Staff who, under Investigator’s direct control, will be engaged in using the Study Drug as contemplated by the Protocol (c) Investigator will maintain a record of receipt and dispensing of the Study Drug. (d) Upon completion of the Study or early termination thereof, all unused Study Drug, compounds, devices, Covance or Sponsor provided equipment, and related Study materials furnished to Institution and Investigator by or on behalf of Sponsor or Covance shall be returned in accordance with the Protocol and as directed by Covance at costs of Sponsor (e) Institution and Investigator acknowledges that the Study Drug is experimental in nature, and therefore shall exercise prudence and reasonable care in, and comply with any Instructions regarding, the use, handling, secure storage, transportation, disposition and containment of the Study Drug, including any derivatives thereof. (f) The Institution and Investigator hereby undertakes: (i) that it will use the services of hospital pharmacy Lekarna Fakultni nemocnice Ostrava (hereinafter the “Pharmacy”), contact person , (hereinafter “Pharmacist”) for receipt storage and 7. HODNOCENÝ PŘÍPRAVEK (a) Zdravotnickému zařízení bude bezplatně poskytnuto dostatečné množství Hodnoceného přípravku, a to výhradně pro účely provádění Studie. Rovněž budou poskytnuty dostupné informace o Hodnoceném přípravku, které Zadavatel považuje za nutné nebo užitečné pro provádění Studie. (b) Zdravotnické zařízení se zavazuje, xx xxxxx přístup k Hodnocenému přípravku pouze na Výzkumný personál, který bude pod přímou kontrolou Zkoušejícího používat Hodnocený přípravek způsobem dle Protokolu (c) Zkoušející povede záznamy o příjmu a výdeji Hodnoceného přípravku. (d) Po dokončení Studie nebo jejím předčasném ukončení se veškerý nepoužitý Hodnocený přípraek, preparáty, zařízení, vybavení poskytnuté společností Covance nebo Zadavatelem a související materiály pro hodnocení poskytnuté Zdravotnickému zařízení a Zkoušejícímu Zadavatelem nebo společností Covance či jejich jménem musí vrátit v souladu s Protokolem a podle pokynů společnosti Covance a na náklady zadavatele- . (e) Zdravotn...
