Good Laboratory Practices. “Good Laboratory Practices” shall mean the FDA’s standards for conducting non-clinical laboratory studies, including those standards contained in 21 C.F.R. Part 58, and all comparable standards of the EMA and any other applicable Governmental Body or other entity with authority over the safety, efficacy, approval, development, testing, labeling, manufacture, storage, marketing, promotion, sale, commercialization, shipment, import, export or distribution of pharmaceutical products.
Appears in 2 contracts
Samples: Agreement and Plan of Merger (Gilead Sciences Inc), Agreement and Plan of Merger (Forty Seven, Inc.)
Good Laboratory Practices. “Good Laboratory Practices” shall mean the FDA’s standards for conducting non-clinical laboratory studiesthe design, including those standards contained conduct, performance, monitoring, auditing, recording, analysis, and reporting of nonclinical studies as set forth in 21 C.F.R. Part 5858 and applicable guidance documents, and all comparable as well as similar applicable standards of the EMA and any other applicable Governmental Body or other entity with authority over the safety, efficacy, approval, development, testing, labeling, manufacture, storage, marketing, promotion, sale, commercialization, shipment, import, export or distribution of pharmaceutical productsin foreign jurisdictions.
Appears in 2 contracts
Samples: Agreement and Plan of Merger (Allergan PLC), Agreement and Plan of Merger (Tobira Therapeutics, Inc.)
Good Laboratory Practices. “Good Laboratory Practices” shall mean means the FDA’s standards for conducting non-clinical laboratory studies, including those standards contained in 21 C.F.R. Part 58, and all comparable standards of the EMA and any other applicable Governmental Body or other entity with authority over the safety, efficacy, approval, development, testing, labeling, manufacture, storage, marketing, promotion, sale, commercialization, shipment, import, export or distribution of pharmaceutical products.
Appears in 1 contract
Good Laboratory Practices. “Good Laboratory Practices” shall mean means the FDA’s standards for conducting non-clinical nonclinical laboratory studies, including those standards contained in 21 C.F.R. Part 58, and all comparable standards of the EMA and any other applicable Specified Governmental Body or other entity with authority over the safety, efficacy, approval, development, testing, labeling, manufacture, storage, marketing, promotion, sale, commercialization, shipment, import, export or distribution of pharmaceutical productsBody.
Appears in 1 contract
Samples: Agreement and Plan of Merger (Juno Therapeutics, Inc.)
Good Laboratory Practices. “Good Laboratory Practices” shall mean the FDA’s standards for conducting non-clinical laboratory studies, including those standards contained in 21 C.F.R. Part 58, and all comparable standards of the EMA and any other applicable Specified Governmental Body or other entity with authority over the safety, efficacy, approval, development, testing, labeling, manufacture, storage, marketing, promotion, sale, commercialization, shipment, import, export or distribution of pharmaceutical productsBody.
Appears in 1 contract
Samples: Agreement and Plan of Merger (Stemline Therapeutics Inc)