Achievement 1

Achievement 1. Shall mean SDI provides documentation that accurately demonstrates that API that has been produced in a commercial batch size (meaning a batch size with a yield of at least approximately { * }; "approximately" in this context means within plus-or-minus { * }) conforms to the Working API Specification throughout (including at each testing point during) and at the end of a { * } month Stability test in which the samples are stored at { * } under conditions of { * } relative humidity for { * }... months. Further details as to stability testing in connection with this definition are as set forth in Exhibit C. "Accurately" in this context means that { * }. View More