OBLIGATIONS OF SPONSOR ČLÁNOK 1 – POVINNOSTI ZADÁVATEĽA Sample Clauses

OBLIGATIONS OF SPONSOR ČLÁNOK 1 – POVINNOSTI ZADÁVATEĽA. Sponsor warrants compliance with all applicable legal requirements for the performance of the Study and assumes, among other things, the following obligations: (a) to obtain the consent of the competent Ethics Committee, and if legally required, the approval of the Competent Authority in Slovakia, to perform the Study; (b) to notify, if required, the Local Health Authorities (all together the “Regulatory Authorities”); and (c) to provide free of charge the Study Investigational Product (as defined in article 5.1) and, where appropriate, any placebo or comparator drug. Zadávateľ sa zaručuje dodržiavať všetky príslušné zákonné požiadavky na vykonávanie štúdie a prijíma, okrem iného, nasledovné povinnosti: (a) získanie súhlasu príslušnej Etickej komisie a, ak sa to vyžaduje na základe právnych predpisov, súhlas príslušného orgánu na Slovensku vykonávať štúdiu; (b) upovedomenie, ak sa to vyžaduje, miestnych orgánov verejného zdravotníctva (spoločne „regulačné úrady“); a (c) bezplatné poskytnutie produktu skúšaného v štúdii (ako je definované v článku 5.1) a, tam, kde je to relevantné, akéhokoľvek placeba alebo or porovnávacieho lieku. ARTICLE 2
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