GOOD CLINICAL PRACTICE or GCP

GOOD CLINICAL PRACTICE or GCP. Means the then-current standards for clinical trials for pharmaceuticals, as set forth in the FD&C Act and such standards of good clinical practice as are required by the European Union and other organizations and governmental agencies in countries in which the Product is intended to be sold, to the extent such standards are not in contravention with United States GCP. 3 * Portions of this exhibit have been omitted and filed separately pursuant to an application for ... confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended. View More