STUDY DRUG AND EQUIPMENT. (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, Labcorp or Sponsor provided equipment, and related Study materials furnished to Institution and Investigator by or on behalf of Sponsor or Labcorp shall be returned or destroyed in accordance with the Protocol and as directed by Labcorp at no cost to the Institution. (e) Institution 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 hereby undertakes: státní správy nebo na základě příkazu příslušného soudu za předpokladu, že v rozsahu povoleném zákonem (i) takové zpřístupnění informací bude podléhat veškeré platné vládní a soudní ochraně, která je k dispozici pro takový materiál, a Poskytovatel bude spolupracovat se Zadavatelem za účelem získání takové ochrany, která bude vyžadována; (ii) že Zadavatel obdrží přijatelně včasné vyrozumění; a (iii) Poskytovatel, Zkoušející a/nebo Výzkumný personál učiní přijatelná opatření k omezení rozsahu takového zpřístupnění. (b) Závazky důvěrnosti zůstávají v platnosti po dobu deseti let po uplynutí platnosti nebo ukončení této Smlouvy. 7.

STUDY DRUG AND EQUIPMENT. 1.5.1 Sponsor shall provide free of charge, or as appropriate, reimburse Institution for materials that Sponsor is required to provide per the Protocol including Study Drug necessary for the conduct of the Study. Institution/Principal Investigator shall not use the Study Drug for any purpose other than the conduct of the Study.

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STUDY DRUG AND EQUIPMENT. (a) Institution and Investigator will be provided with sufficient amounts of the Study Drug (including placebo) and reference product as stated in Protocol (hereinafter referred to as “Reference Product”) for the purposes 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) Upon completion of the Study or early termination thereof, Investigator shall conduct and document a final drug supply (used and unused) inventory. An explanation will be given for any discrepancies. All unused Study Drug, Reference Product, compounds, devices, third-party provided equipment, and related Study materials furnished to Institution and Investigator by or on behalf of Sponsor or Chiltern shall be returned in accordance with the Instructions and the Protocol at no expense to the Institution. (c) Institution 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. Institution agrees to limit access to the Study Drug and Reference Product to only Research Staff who, under Investigator’s direct control, will skúšajúcemu alebo výskumnému personálu treťou stranou, ktorá má na sprístupnenie týchto informácií „nedôverným“ spôsobom zákonné právo; (iii) informácie, ktoré, ako vyplýva z predchádzajúcich písomných záznamov, sú už inštitúcii, skúšajúcemu alebo výskumnému personálu známe; (iv) informácie, ktoré je potrebné sprístupniť štátnemu orgánu alebo na základe nariadenia príslušného súdu za predpokladu, že v rozsahu, ktorý povoľuje zákon, (i) toto sprístupnenie podlieha všetkej príslušnej vládnej alebo súdnej ochrane, ktorá je k dispozícii pre podobný materiál a inštitúcia na dôvodné požiadanie spolupracuje so zadávateľom na zabezpečení tejto ochrany; (ii) xx xxxx skutočnosť oznámi zadávateľovi dostatočne vopred; a (iii) inštitúcia, skúšajúci alebo výskumný personál podniknú primerané kroky na obmedzenie rozsahu tohto sprístupnenia. 9.

STUDY DRUG AND EQUIPMENT. (a) Institution and Investigator will be provided with sufficient amounts of the 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 or destroyed in accordance with the Protocol and as directed by Covance at no cost to Institution or Investigator. (e) Institution and Investigator acknowledge 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 they will use the Institutional pharmacy University Hospital Plzeň-Bory, Edvarda Xxxxxx 0000/00, 000 00 Xxxxx, Xxxxx Xxxxxxxx (hereinafter the “Pharmacy”), contact person will be listed in the log of authorized employees (“Delegation Log”) (hereinafter “Pharmacist”) for receipt storage and distribution of the Study Drug (ii) that the Study Drug shall be handled in accordance to good pharmacy, storage and distribution practice according to Act No. 378/2007 Sb., Collection of Laws, on therapeutic agents amended by Regulation No. 226/2008 Sb., Collection of Laws, on good clinical practice and the detailed conditions of the clinical assessment of therapeutic agents and in accordance to Regulation No. 229/2008 Sb., Collection of Laws, on the manufacture and distribution of therapeutic agents including current exceptions. Covance is required to make an initial visit to the authorized (10) let po uplynutí platnosti nebo ukončení této Smlouvy. 7. HODNOCENÝ LÉČIVÝ PŘÍPRAVEK A VYBAVENÍ (a) Poskytovatelia Zkoušejícímu bude bezplatně poskytnuto dostatečné množství Hodnoceného léčivého přípravku, a to výhradně pro účely provádění Studie. Rovněž budou...

STUDY DRUG AND EQUIPMENT 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 The Investigator shall confirm receipt of the Study Drug by signing the appropriate document(s)/form(s) provided by the Sponsor, Chiltern or a supplier designated by the Sponsor or Chiltern. 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. The Investigator agrees to store the provided Study Drug securely as designated in the Protocol, but in any event, in either a central pharmacy where a qualified pharmacist supervises dispensing or in a restricted area and dispensed under the direct supervision of the Investigator.Investigator will maintain a complete and accurate record of receipt, dispensing and destruction of the Study Drug or other Study provided products.

STUDY DRUG AND EQUIPMENT 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 souladu s platnými zákony na ochranu osobních údajů získali potřebné souhlasy výzkumného personálu pro sběr, zpracování, ukládání a přenos jejich Osobních údajů společností Chiltern nebo Zadavatelem pro výše uvedené účely.

STUDY DRUG AND EQUIPMENT. Institution and Investigator will be provided with sufficient amounts of the Study Drug solely for the purpose of conducting the Study, free of charge; and with available information on the Study Drug, which Sponsor considers necessary or useful for conducting the Study. Institution agrees to limit access to the Study Drug to only Research Staff who, under Investigator’s direct control or supervision, will be engaged in using the Study Drug as contemplated by the Protocol. Investigator will maintain a record of receipt and dispensing of the Study Drug. Upon completion of the Study or early termination thereof, all unused Study Drug, compounds, devices, Fortrea or Sponsor provided equipment, and related Study materials furnished to Institution and Investigator by or on behalf of Sponsor or Fortrea shall be returned or destroyed in accordance with the Protocol and as directed by Xxxxxxx at no cost to Institution or Investigator. Institution and Investigator acknowledge 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.

STUDY DRUG AND EQUIPMENT. (a) Institution either directly or through its Investigator will be provided with sufficient amounts of the Study Drug solely for the purpose of conducting of the Study, free of charge, and with available information on the Study Drug, which Sponsor considers necessary or useful for conducting the Study. (b) Institution agrees to limit access to the Study Drug to only Research Staff who, under Investigator’s direct control or supervision, will be engaged in using the Study Drug as contemplated by the Protocol. (c) Institution shall not hinder Investigator in maintaining a record of receipt and dispensing of (iv) Důvěrné informace, které byly nezávisle vyvinuty Zdravotnickým zařízením a/nebo Zkoušejícím bez použití Informací nebo bez odkazu na ně. (b) Zdravotnické zařízení je oprávněno sdělit Informace v rozsahu stanoveném Platnými zákony nebo na základě jakéhokoli rozhodnutí, nařízení, obsílky, vládního nebo regulačního požadavku nebo jiného právního postupu za předpokladu, že Zdravotnické zařízení o tomto požadavku neprodleně uvědomí, pokud mu v xxx nebudou bránit Platné zákony nebo pokud to nebude možné, společnost Fortrea a Zadavatele dříve, než toto sdělení uskuteční, a poskytne společnosti Fortrea a/nebo Zadavateli součinnost v úsilí zabránit požadovanému sdělení, minimalizovat ho nebo zajistit důvěrné zacházení s požadovaným sdělením v rozsahu tohoto příkazu nebo jak to bude přiměřeným způsobem proveditelné. Zkoušející a/nebo Výzkumný personál v každém případě omezí toto sdělení Informací na minimální požadovaný rozsah. (c) Xxxxxxx zachování důvěrnosti zůstanou v platnosti po dobu deseti let po uplynutí platnosti nebo ukončení této smlouvy. 7.

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