Supply of Investigational Drug Sample Clauses

Supply of Investigational Drug. The Sponsor and/or its Affiliate shall supply the Institution/Principal Investigator with quantities of the Investigational Drug adequate for the Institution/Principal Investigator to conduct the Study in accordance with the Protocol. The Investigational Drug shall remain the sole property of the Sponsor and/or its Affiliate. The Institution/Principal Investigator shall take reasonable steps to ensure that it has adequate supplies of the Investigational Drug, shall store, use, handle, and return or dispose of the Investigational Drug in accordance with the Protocol, and shall not use any Investigational Drug after its labeled expiration date. 3.2
Sample 1
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Supply of Investigational Drug. The Sponsor and/or its Affiliate shall supply the Institution with quantities of the Investigational Drug adequate for the Institution to conduct the Study in accordance with the Protocol. The Investigational Drug shall remain the sole property of the Sponsor and/or its Affiliate. The Institution shall take reasonable steps to ensure that it has adequate supplies of the Investigational Drug, shall store, use, handle, and return or dispose of the Investigational Drug in accordance with the Protocol, and shall not use any Investigational Drug after its labeled expiration date. 3.2 Dodávání hodnoceného léčiva. Zadavatel a/nebo jeho sesterská společnost bude zdravotnickému zařízení dodávat taková množství hodnoceného léčiva, která jsou adekvátní k tomu, aby zdravotnické zařízení mohlo provádět studii v souladu s protokolem. Hodnocené léčivo zůstává výhradním vlastnictvím zadavatele a/nebo jeho sesterské společnosti. Zdravotnické zařízení podnikne přiměřené kroky, aby zajistilo, že bude mít k dispozici adekvátní zásoby hodnoceného léčiva, a hodnocené léčivo bude uchovávat, používat, zacházet s ním a vracet je nebo je likvidovat v souladu s protokolem, a žádné hodnocené léčivo nepoužije po uplynutí vyznačené exspirační doby.
Sample 1
Supply of Investigational Drug. The Sponsor shall ensure the distribution of shipments of the Investigational Drug and placebo to the Institution’s pharmacy, where it shall be accepted and inspected by the delegated pharmacist (using the same procedure as for other shipments – i.e. check that no damage is present, in case of special transportation requirements, check that these requirements have been complied with, and confirm acceptance of the shipment). Subsequently, based on a request form, the Principal Investigator shall collect the Investigational Drug and shall assume full responsibility for it. The Sponsor shall be obliged to provide a notification at least 3 working days prior to the delivery when the shipment will be delivered to the pharmacy, either by email via IVRS to the address The Institution shall notify Sponsor of unused drugs in need of disposal or collection and shall cooperate with Sponsor 3.2 Dodávání hodnoceného léčiva. Zadavatel zajistí distribuci zásilky hodnoceného léčiva a placeba do lékárny zdravotnického zařízení, kde je odpovědný farmaceut převezme a zkontroluje (jako jiné zásilky - tzn., není-li poškozena, v případě zvláštních požadavků na transport, byly-li tyto požadavky dodrženy, příjem zásilky potvrdí), následně si na žádanku hlavní zkoušející hodnocené léčivo vyzvedne a je za ně plně zodpovědný. Zadavatel je povinen oznámit do 3 pracovních dnů před dodáním, kdy bude zásilka do lékárny předána buďto přes IVRS, emailem na . Zdravotnické zařízení bude Zadavatele informovat o nevyužitých lécích, které bude třeba zlikvidovat nebo shromáždit, a bude se Zadavatelem při této likvidaci či sběru spolupracovat. Likvidaci či sběr nevyužitých léků si zadavatel zajistí na vlastní náklady. in such disposal or collection. Sponsor shall arrange for the disposal or collection of unused drugs at Sponsor’s cost. The Sponsor undertakes to provide the Investigational Drug and placebo in the amount and time intervals needed for the proper conduct of the Study. The Sponsor declares that all the conditions stipulated in the relevant legislation have been met for manufacture (import) of delivered investigational products and their distribution to the Institution. The Sponsor, as the source of waste, undertakes to ensure at Sponsor’s own costs, both during and after the clinical trial, the transfer of unusable and unused medicinal product to an authorized person in accordance with the provisions of the Act No. 185/2001 Coll., on waste and its implementing regulations, as amended...
Sample 1

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