GLP Studies Documentation Clause Samples

GLP Studies Documentation. PFIZER will provide to LICENSEE copies of protocols, data, results and reports that were generated as part of GLP Studies conducted by or on behalf of PFIZER. As used herein, “GLP Studies” means non-clinical toxicology and safety studies of ETC-216 that are: (a) conducted in accordance with the standards for good laboratory practices under the ICH guidelines and the applicable standards under the laws of the United States, and (b) filed or intended by PFIZER to be filed as part of the Regulatory Filings.