Trial Drug. 2.1 Hodnocené léčivo.
Trial Drug. (i) Institution and Investigator acknowledge that the Compound is owned or controlled by Gilead and that neither the terms of this Agreement nor the Protocol, nor any activities conducted by Institution or Investigator for the Trial, shall be construed to grant to either Institution or Investigator any rights in or to the Compound. (ii) Except as otherwise agreed by the Parties, Gilead will provide the Compound and any control/placebo materials administered to Trial subjects as part of the Trial (collectively, the “Trial Drug”) free of charge to Institution for administering or dispensing solely by or under the supervision of Investigator or sub- investigators to Trial subjects at the Trial Site in strict compliance with the Protocol. (iii) Institution and Investigator shall use the Trial Drug solely to conduct the Trial in strict compliance with the Protocol and for no other purpose, and shall not transfer the Trial Drug to any third parties. Institution and Investigator shall handle, store, ship and dispose of the Trial Drug as directed by Gilead or its designee and in compliance with all úřady, společností Gilead, smluvní výzkumnou organizací, jejich jednateli a přidruženými osobami; (iii) dodržování zákonných a právních požadavků; (iv) zveřejnění na internetových stránkách na adrese xxx.xxxxxxxxxxxxxx.xxx a na internetových stránkách a v databázích, které slouží podobným účelům; a (v) uchovávání v databázích k umožnění výběru zkoušejících pro budoucí klinická hodnocení. Osobní údaje mohou být zpřístupněny nebo poskytnuty přidruženým nebo dceřiným společnostem, zástupcům a smluvním partnerům společnosti Gilead pracujícím jménem společnosti Gilead a kontrolním úřadům po celém světě. Instituce zajistí, aby byly podepsány veškeré dokumenty souhlasu s použitím těchto údajů pro účely popsané v tomto Článku. 2. ZKOUŠENÉ LÉČIVO, PŘEVOZ MATERIÁLU, UKLÁDÁNÍ ÚDAJŮ, KONTROLA; VYBAVENÍ 2.1 Zkoušené léčivo. (i) Instituce a Zkoušející jsou si vědomi, že Sloučenina je vlastněna nebo řízena společností Gilead a že žádná podmínka této Smlouvy ani Protokolu, ani žádná činnost prováděná Institucí nebo Zkoušejícím v rámci Studie nebude vykládána jako udělení jakéhokoli práva ke Sloučenině Instituci nebo Zkoušejícímu. (ii) Pokud se Smluvní strany nedohodnou jinak, společnost Gilead poskytne Sloučeninu a jakékoli kontrolní či placebo látky podávané subjektům ve Studii jako součást Studie (souhrnně “Zkoušené léčivo”) bezplatně Instituci k podávání nebo nakládání s ní pouze po...
Trial Drug. (i) Institution and Investigator acknowledge that the Compound is owned or controlled by Gilead and that neither the terms of this Agreement nor the Protocol, nor any activities conducted by Institution or Investigator for the Trial, shall be construed to grant to either Institution or Investigator any rights in or to the Compound. (ii) Except as otherwise agreed by the Parties, Gilead will provide the Compound and any control/placebo materials administered to Trial subjects as part of the Trial (collectively, the “Trial Drug”) free of charge to Institution for administering or dispensing solely by or under the supervision of Investigator or sub- investigators to Trial subjects at the Trial Site in strict compliance with the Protocol. (iii) Institution and Investigator shall use the Trial Drug solely to conduct the Trial in strict compliance with the Protocol and for no other purpose, and shall not transfer the Trial Drug to any third parties. Institution and Investigator shall handle, store, ship and dispose of the Trial Drug as directed by Gilead or its designee and in compliance with all applicable laws, rules, and regulations. (iv) Institution and Investigator will ensure that empty and partially used Trial Drug containers and any Trial Drug remaining at the Trial close-out visit at the Trial Site or upon early termination of this Agreement are disposed of or returned to Gilead in accordance with the Protocol. (v) Neither Gilead’s support of the Trial, nor Institution’s or Investigator’s participation in the Trial, impose any obligation, express or implied, for Institution or Investigator to purchase, prescribe, provide favorable formulary status for, or otherwise support Xxxxxx’s products. (vi) Unless required by the Protocol, neither Institution nor Investigator will 2. ZKOUŠENÉ LÉČIVO, PŘEVOZ MATERIÁLU, UKLÁDÁNÍ ÚDAJŮ, KONTROLA; VYBAVENÍ 2.1 Zkoušené léčivo. (i) Instituce a Zkoušející jsou si vědomi, že Sloučenina je vlastněna nebo řízena společností Gilead a že žádná podmínka této Smlouvy ani Protokolu, ani žádná činnost prováděná Institucí nebo Zkoušejícím v rámci Studie nebude vykládána jako udělení jakéhokoli práva ke Sloučenině Instituci nebo Zkoušejícímu. (ii) Pokud se Smluvní strany nedohodnou jinak, společnost Gilead poskytne Sloučeninu a jakékoli kontrolní či placebo látky podávané subjektům ve Studii jako součást Studie (souhrnně “Zkoušené léčivo”) bezplatně Instituci k podávání nebo nakládání s ní pouze podle určení nebo pod dohledem Zkou...
Trial Drug. (i) Institution and Investigator acknowledge that the Compound is owned or controlled by Gilead and that neither the terms of this Agreement nor the Protocol, nor any activities conducted by Institution or Investigator for the Trial, shall be construed to grant to either Institution or Investigator any rights in or to the Compound. (ii) Parties agreed that Gilead will provide the xxxxxxxx. and any control/placebo materials administered to Trial subjects as part of the Trial (collectively, the “Trial Drug”) free of charge to Institution for administering or dispensing solely by or under the supervision of Investigator or sub- investigators to Trial subjects at the Trial Site in strict compliance with the Protocol. xxxxxxxx. will be provided by the Institution, as per Investigator’s choice. Gilead agrees to reimburse locally supplied drugs as per current Institution’s Pharmacy selling price in compliance with the rules of drug pricing according to the valid legislation in the Czech republic. Trial Drug shipment will be marked with the name of responsible pharmacists, study protocol number and will be shipped to Institution’s pharmacy, as below: xxxxxxxx.Lékárna FNO 17. listopadu 1790 70 852 Ostrava – Poruba Czech Republic GS-US-558-5915 The Institution's pharmacy will be responsible for receiving the shipment, Trial Drug storage, and dispensing the Trial Drug to the Principal Investigator or a person authorized by him. (iii) Institution and Investigator shall use the Trial Drug solely to conduct the Trial in strict compliance with the Protocol and for no other purpose, and shall not transfer the Trial Drug to any third parties. Institution and Investigator shall handle, store, ship of the Trial Drug as directed by Gilead or its designee and in compliance with all applicable laws, rules, and regulations. 2.1 Zkoušené léčivo. (i) Instituce a Zkoušející jsou si vědomi, že Sloučenina je vlastněna nebo řízena společností Gilead a že žádná podmínka této Smlouvy ani Protokolu, ani žádná činnost prováděná Institucí nebo Zkoušejícím v rámci Studie nebude vykládána jako udělení jakéhokoli práva ke Sloučenině Instituci nebo Zkoušejícímu. (ii) Smluvní strany se dohodli, že společnost Gilead poskytne xxxxxxxx. a jakékoli kontrolní či placebo látky podávané subjektům ve Studii jako součást Studie (souhrnně “Zkoušené léčivo”) bezplatně Instituci k podávání nebo nakládání s ní pouze podle určení nebo pod dohledem Zkoušejícího nebo spolu-zkoušejících, a to subjektům Studie v...
Trial Drug. Sponsor or its designee will provide the Trial Drug ( medicinal drug with active substances tivozanib and sorafenib) at no cost to Institution or Investigator in amounts sufficient for the conduct of the Trial, as well as certain materials to be determined by Sponsor at its sole discretion (collectively, the “Trial Supplies”). All Trial Supplies are and will remain the sole property of Sponsor. Institution and Investigator will maintain control of the Trial Drug in accordance with Applicable Law (as well as with the applicable terms and conditions stipulated by LEK-12 Directive issued by State Institute for Drug Control), and in the manner outlined in the Protocol and any additional documents provided by Sponsor or its designee related to the storage and distribution of the Trial Drug. Institution and Investigator will ensure that the Trial Supplies are (i) solely used for the purpose of conducting the Trial in accordance with the Protocol and for no other purpose; (ii) stored separately from other medication in the pharmacy; and (iii) that the Trial Supplies are not transferred to any third parties. Institution and Investigator will be responsible to Sponsor for the Trial Supplies entrusted to them and will notify Sponsor or its designee immediately if any Trial Supplies are lost, damaged or destroyed. 4.
Trial Drug. An Investigational Medical Product (“Investigational Product”) as defined in Art. 2 lit. d) Directive 2001/20/EC and therefore including all products used in a clinical trial, no matter if it is just a placebo or a reference product. All technical words not defined above shall match ICH-GCP standards and therefore be defined according to the Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) from July 2002. Art. 2
Trial Drug. (i) Institution and Investigator acknowledge that the Compound is owned or controlled by Gilead and that neither the terms of this Agreement nor the Protocol, nor any activities 2.1 Zkoušené léčivo. (i) Instituce a Zkoušející jsou si vědomi, že Sloučenina je vlastněna nebo řízena společností Gilead a že žádná podmínka této Smlouvy ani Protokolu, ani žádná činnost
Trial Drug. Sponsor or its designee will provide the Trial Drug at no cost to Institution or Investigator in amounts sufficient for the conduct of the Trial, as well as certain materials to be determined by Sponsor at its sole discretion (collectively, the “Trial Supplies”). All Trial Supplies are and will remain the sole property of Sponsor. Institution and Investigator will maintain control of the Trial Drug in accordance with Applicable Law (as well as with the applicable terms and conditions stipulated by LEK-12 Directive issued by State Institute for Drug Control), and in the manner outlined in the Protocol and any additional documents provided by Sponsor or its 4.
Trial Drug. CRO, on behalf of Sponsor, will provide Institution with sufficient quantities of the Trial Drug to conduct the Trial, at no cost to the Institution. If required by the Protocol and unless otherwise agreed, CRO, on behalf of Sponsor, will also provide Trial medication supplies (“Trial Medication Supplies”) and comparator drug (“Comparator Drug”) at no cost to the Institution. CRO shall ensure distribution of Sponsor Drug and Comparator Drug shipment to the Institution´s pharmacy where the responsible pharmacist shall hand over and check it (like other shipments – i.e. if it is undamaged, in case of special requirements for transport, if these requirements have been fulfilled, confirmation of the takeover of shipment) and consequently Principal Investigator shall collect Trial Drug using the request form and being fully responsible for it at site. CRO is obliged to announce within 3 business days prior to the delivery when the shipment shall be handed over to pharmacy, either via email xxxxxx.xxxxxxx@xxx.xx or via phone to responsible pharmacists PharmDr. X. Xxxxxxxxx, Xxx. X. Smekalova, tel. +000000000000, +000000000000. CRO shall ensure on its expense that unused drugs shall be destroyed. CRO shall ensure the delivery to the address: Lekarna VFN - oddeleni HVLP, Ke Xxxxxxx 0, 000 00 Xxxxx 0, Xxxxx Xxxxxxxx. CRO undertakes to ensure Trial Drug in a quantity and at time intervals needed for the proper conduct of the Trial. CRO represents that all conditions stipulated in relevant legal regulations concerning the manufacture (import) of the distributed Trial Drug and its distribution to the Institution are met. Sponsor, as a waste originator, undertakes to ensure on its expense, both in the course of the Trial and after completion of the Trial, that unusable and unused Trial stanovisko NEK. Společnost CRO předloží NEK a příslušnému orgánu, jménem zadavatele, všechny výše uvedené materiály jak byly zadavatelem předem písemně schváleny. V souvislosti s prováděním klinického hodnocení jsou zadavatel a společnost CRO odpovědní za plnění veškerých zákonných povinností, včetně povinností informačních, ve vztahu ke Státnímu ústavu pro kontrolu léčiv (SUKL) a etickým komisím. Zdravotnické zařízení neprodleně přepošle společnosti CRO veškerou korespondenci přijatou nebo odeslanou NEK a příslušnému orgánu týkající se klinického hodnocení a to do čtyřiadvaceti (24) hodin od přijetí. 4. Hodnocený přípravek. Společnost CRO, jménem zadavatele, poskytne zdravotnickému zaří...
Trial Drug. Sponsor or its designee will 4.
