Reserve Samples. Formosa shall keep retention samples of raw materials as required by [***] SOPs and Regulatory Requirements under the recommended storage conditions or better. Formosa shall keep retention samples of regulatory starting materials, intermediates (where applicable) and drug substance as required by Regulatory Requirements, for each batch of API produced. The quantity of starting materials and intermediates should be [***] the amount required to perform all physical and chemical tests according to the specification. Intermediate samples need to be held until the final API has been released by NGX. The quantity of API retained should be at least [***] the amount to be able to perform all physical and chemical tests according to the Certificate of Analysis. Formosa will visually inspect all retain samples annually and inform NGX within [***] if any unusual observations are made during the inspections.
Appears in 2 contracts
Sources: Manufacturing Agreement, Manufacturing and Supply Agreement (NeurogesX Inc)