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. Study Drug shall be delivered to Institution’s hospital dispensary. 6.1 H odnocený léčivý přípravek. Hodnocené léčivo bude dodáno do nemocniční lékárny Zdravotnického zařízení. Institution and Principal Investigator shall ensure that: Zdravotnické zařízení a Hlavní zkoušející zajistí, aby:
(a) all samples of the compound identified in the Protocol that is being tested in the Study (“Study Drug”) are stored safely and securely protected from access by unauthorized personnel and in accordance with the Protocol and Sponsor’s storage specifications; (a) všechny vzorky sloučeniny určené v Protokolu, která je testována v rámci Klinického hodnocení („Hodnocený léčivý přípravek“), byly bezpečně a spolehlivě chráněny před přístupem neoprávněného personálu v souladu s Protokolem a specifikacemi Zadavatele pro uchovávání;
(b) Study Drug is dispensed only to Study Subjects, in accordance with the Protocol, and under no circumstances sold or given to any other individual(s) or otherwise used for any other purpose than the execution of the Protocol or used other than in accordance with the Protocol; (b) Hodnocený léčivý přípravek byl vydáván pouze Subjektům hodnocení v souladu s Protokolem a za žádných okolností nebyl prodán nebo vydán jiné osobě (jiným osobám) nebo použit jinak pro žádné jiné účely než pro plnění Protokolu ani nebyl použit jinak než v souladu s Protokolem;
(c) accurate records are maintained specifying the receipt by Institution, the dispensation to and use by Study Subjects and the return to Sponsor or alternative disposition of any quantities of Study Drug; and (c) byly vedeny přesné záznamy, v nichž bude specifikováno přijetí Zdravotnickým zařízením, vydání Subjektům hodnocení a užívání Subjekty hodnocení a vrácení Zadavateli nebo jiné nakládání s Hodnoceným léčivým přípravkem v jakémkoli množství; a
(d) any unused quantities of the Study Drug are returned to the Sponsor or certified destroyed or otherwise disposed of in accordance with Xxxxxx Clinical’s instructions at the Sponsor’s expense, and Xxxxxx Clinical is provided with a certificate of such disposal or destruction promptly thereafter. (d) veškeré nespotřebované množství Hodnoceného léčivého přípravku bylo na náklady Zadavatele vráceno Zadavateli nebo prokazatelně zničeno nebo jinak zlikvidováno v souladu s pokyny společnosti Xxxxxx Clinical, přičemž se společnosti Xxxxxx Clinical neodkladně poté předá certifikát o takové likvidaci nebo zničení.
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) 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. 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) 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.
Study Drug. (a) Institution and Investigator will be provided with sufficient amounts of the Study Drug solely for the purposes
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.
Study Drug. Investigator shall use the Study Drug only pursuant to and in accordance with the Protocol and this Agreement, and for no other purpose. Institution shall notify Sponsor and Institution’s IRB regarding any use of the Study Drug without obtaining informed consent as soon as possible, but no later than five (5) business days after becoming aware of such use. < Institution> CTA
