Pre-defined SAEs. For the purposes of this study, the following events will be defined as serious: · re-infarction · stroke or transient ischemic attack (TIA) · acute heart failure (decompensation) The occurrence of any of these events after implantation of BL-1040 will be considered an SAE; they are to be reported and followed up as specified in Sections 7.5.3 and 7.5.4.
Appears in 7 contracts
Samples: License and Commercialization Agreement (Bellerophon Therapeutics, Inc.), License and Commercialization Agreement (Bellerophon Therapeutics LLC), License and Commercialization Agreement (Bellerophon Therapeutics LLC)
