Manufacturing Records. HPA shall maintain, or cause to be maintained, (a) all records necessary to comply with all Applicable Law relating to the Manufacture of the Licensed Products by HPA, (b) all Manufacturing records, standard operating procedures, equipment log books, batch records, laboratory notebooks and all raw data relating to the Manufacturing of Licensed Products hereunder, and (c) such other records as Emergent may reasonably require to ensure compliance by HPA with the terms hereof. All such material shall be maintained for such period as may be required by Applicable Law or for such longer period as Emergent may reasonably require; provided, however, that all records relating to the Manufacturing, stability and quality control of each batch of Licensed Product shall be retained until at least the first (1st) anniversary of the end of the approved shelf life for all Licensed Product from such batch.
Appears in 2 contracts
Sources: Rbot Vaccine Development Agreement (Emergent BioSolutions Inc.), Bt Vaccine Development Agreement (Emergent BioSolutions Inc.)