Achievement 2

Achievement 2. Shall mean SDI provides documentation that accurately demonstrates that Finished Product that: (a) is an IR Product the dosage of which is equal to { * } of API (not more not less), (b) has been produced in a batch size sufficient such that no bridging for commercial batch size will be required (and in any event no less than { * } tablets as the batch size) under GMP requirements, and (c) has been packaged in { * }; conforms to the Working Finished Product Specification throughout (including at... each testing point during) and at the end of a { * } month Stability test in which the samples are stored at { * } and { * } relative humidity for { * } months. Further details as to stability in connection with this definition are as set forth in Exhibit C. "Accurately" in this context means that { * }. View More