BI Pharma Responsibilities Sample Clauses

BI Pharma Responsibilities. Prior to delivery to BI Pharma, BI Pharma shall determine whether the Drug Product conforms to applicable specifications for use in human clinical trials (the "Review"). BI Pharma may conduct a Review by: (i) reviewing the Certificate of Analysis and the Manufacturing Documentation and such other documents, if any, as BI Pharma may request; and (ii) conducting acceptance testing of a representative sample of the Drug Product Batch. BI Pharma shall conduct its Review within [ * ] of the receipt of a representative sample of the Drug Product Batch including Manufacturing Documentation of Drug Substance, [ * ] that [ * ] have a [ * ] of [ * ] for [ * ] after [ * ] of [ * ] and [ * ] after [ * ] of [ * ] the [ * ] .