BACKGROUND ZÁKLADNÍ INFORMACE Sample Clauses

BACKGROUND ZÁKLADNÍ INFORMACE. The Parties entered into a Clinical Site Agreement on 2nd June 2016 (the "Agreement”), which the Parties desire to amend as set out in Section 2 below. 1.
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BACKGROUND ZÁKLADNÍ INFORMACE. The Company is engaged in the development of Tucatinib (the “Product”). A. Společnost je zapojena do vývoje Tucatinib (dále jen „produkt“).
BACKGROUND ZÁKLADNÍ INFORMACE. 1.1 ICON is a clinical research organization principally engaged in the design, set-up and management of human clinical trials, and other related services, on behalf of the producers of pharmaceutical products. ICON is, therefore, a “Contract Research Organization” within the meaning of Act. No. 378/2007 Coll. on Pharmaceuticals. The Contract Research Organisation organizes the (multicenter) clinical trial on a medicinal product and entered into an agreement with the Sponsor on the organization and, financing of the clinical trial. ICON agrees to performthe applicable obligations in this Agreement. ICON has its registered office in Ireland. Společnost ICON je organizace zabývající se klinickým výzkumem, která se především zabývá přípravou, organizací a řízením klinických hodnocení prováděných na lidských subjektech a ostatními souvisejícími službami, a to jménem výrobců farmaceutických přípravků. ICON je tedy „smluvní výzkumnou organizací“ ve smyslu zák. č. 378/2007 Sb., o léčivech. Smluvní výzkumná organizace organizuje (multicentrické) klinické hodnocení léčivého přípravku a uzavřela se zadavatelem dohodu o organizování a financování klinického hodnocení. ICON přejímá závazky dle této smlouvy. ICON je usazen na území Irska. 1.2 ICON’S client, GUERBET, (hereinafter known as the “Sponsor”) is developing an investigational product called P03277 (Formulation G03277) (hereinafter called the “Investigational Product”) for use in patients with a brain or spine lesion and have been scheduled to receive a routine MRI with injection of contrast agent to help establish the diagnosis or to make an evaluation after or before treatment. (hereinafter called the “Study Indication”). Klient společnosti ICON, společnost GUERBET, (dále jako „zadavatel“) vyvíjí hodnocený přípravek s označením P03277 (léková forma G03277) (dále jako „hodnocený přípravek“) pro použití u subjektů s mozkovými nebo míšními lézemi, u kterých je plánováno rutinní vyšetření magnetickou rezonancí s aplikací injekce kontrastní látky za účelem určení diagnózy nebo provedení vyhodnocení před léčbou nebo po ní (dále jako „indikace pro studii“). 1.3 The Institution and its staff, including without limitation the Investigator, are experienced in the evaluation and treatment of patients with a brain or spine lesion and have been scheduled to receive a routine MRI with injection of contrast agent to help establish the diagnosis or to make an evaluation after or before treatment. The Institution is a public ...
BACKGROUND ZÁKLADNÍ INFORMACE. The Company is engaged in the development of Brentuximab Vedotin (the “Product”). A. Společnost je zapojena do vývoje Brentuximab Vedotin (dále jen „produkt“).

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