Common use of Testing and Inspection of Product Clause in Contracts

Testing and Inspection of Product. BLP shall conduct all quality control and other tests required to ensure that the Product as manufactured meets the Specifications. The cost of all such analyses and evaluations shall be borne by BLP. During the commercial phase of the project, BLP shall conduct stability testing on [*] for each fill size of the Product annually, and shall provide ISTA with on-going stability reports. BLP will place each of the Validation Batches into on-going stability studies and will provide interim stability reports to ISTA, as required by cGMP regulations. BLP will perform annual product reviews of the Product and will promptly provide ISTA with the information from the annual product reviews as required by the FDA, for ISTA's inclusion in annual reports to the FDA. BLP shall provide ISTA, [*] with all regulatory support and documentation required by the FDA to support the NDA for the Product.

Appears in 2 contracts

Samples: Supply Agreement (Ista Pharmaceuticals Inc), Supply Agreement (Ista Pharmaceuticals Inc)

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Testing and Inspection of Product. BLP shall conduct all quality control and other tests required to ensure that the Product as manufactured meets the Specifications. The cost of all such analyses and evaluations shall be borne by BLP. During the commercial phase of the project, BLP shall conduct stability testing on [*] for each fill size of the Product annually, and shall provide ISTA with on-going stability reports. BLP will place each of the Validation Batches into on-going stability studies and will provide interim stability reports to ISTA, as required by cGMP regulations. BLP will perform annual product reviews of the Product and will promptly provide ISTA with the information from the annual product reviews as required by the FDA, for ISTA's inclusion in annual reports to the FDA. BLP shall provide ISTA, [*] ], with all regulatory support and documentation required by the FDA to support the NDA for the Product.

Appears in 2 contracts

Samples: Contract Manufacturing Supply Agreement (Ista Pharmaceuticals Inc), Contract Manufacturing Supply Agreement (Ista Pharmaceuticals Inc)

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