{"component": "clause", "props": {"groups": [{"snippet": "(i) API Intermediate Testing. GSK will re-test the API Intermediate listed on Schedule 4.4(a) prior to the Closing Date and, at Closing, GSK shall notify Prometheus of any API Intermediate that is not usable and such amounts shall not be available for purchase by Prometheus or included as part of the one-time manufacture of API under Section 4.4(a). 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