CLINICAL TRIAL AGREEMENT(“Agreement”) between Boehringer Ingelheim RCV GmbH & Co KGDr. Boehringer-Gasse 5-11, 1121 Vienna, AustriaVAT-ID-No.: ATU 64226215("Sponsor”) andFakultní Nemocnice Ostrava,17. listopadu 1790/5, 708 52 Ostrava- Poruba, Czech...Clinical Trial Agreement • June 24th, 2024
Contract Type FiledJune 24th, 2024RECITALS ÚVODNÍ USTANOVENÍ WHEREAS, Sponsor, a research-driven pharmaceutical company, is conducting a clinical trial of BI 456906 (“Investigational Product”) according to the Clinical Trial Protocol for BI Trial No. 1404-0040 including all documents attached thereto and referenced therein (“Protocol”) entitled “A Phase 3, randomised, double-blind, parallel-group, event-driven, cardiovascular safety study with BI 456906 administered subcutaneously compared with placebo in participants with overweight or obesity with established cardiovascular disease (CVD) or chronic kidney disease, and/or at least two weight- related complications or risk factors for CVD.” as amended (“Trial”), incorporated herein by reference and provided to Institution and/or Investigator by the Sponsor under separate cover in the regulatory document package; and VZHLEDEM K TOMU, ŽE Zadavatel jakožto výzkumná farmaceutická společnost provádí klinické hodnocení BI 456906 (dále jen „Hodnocený léčivý přípravek“) podle