INDEnabling Studies

INDEnabling Studies. Shall mean the first safety study, pharmacology study or pharmacokinetic study conducted in animals according to the Good Laboratory Practices required by regulatory Authorities for pharmaceutical products. For the avoidance of doubt, IND-Enabling Studies are those that are required by regulation to be a component of an IND submission to a regulatory authority and shall not include pilot or similar studies that may be conducted by Acquirer in accordance with Good Laboratory Practices.