Biological Samples means any physical samples obtained from Study Participants in accordance with the Protocol for the purposes of the Study.
Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood
Biological Material means any material containing genetic information and capable of reproducing itself or being reproduced in a biological system;
Biological agent shall mean any pathogenic (disease producing) micro-organism(s) and/or biologically produced toxin(s) (including genetically modified organisms and chemically synthesized toxins) which cause illness and/or death in humans, animals or plants.
Active Pharmaceutical Ingredient or “API” means the active pharmaceutical substance of the Drug in bulk form prior to incorporation into the Product.