Yield Requirement Clause Samples

Yield Requirement. Following the Production of (a) the [***] ([***]) process validation Batches of each Presentation of Product and (b) the initial [***] ([***]) post-process validation Batches of each Presentation of Product (the “Yield Batches”) the parties will determine the expected yield (“EY”) for each Presentation of Product, which EY shall be equal to the [***] by Presentation resulting from the Yield Batches less [***]. If there is a manufacturing anomaly in one or more of the Yield Batches, the parties may agree to eliminate such Batch from the EY calculation or may require an additional Batch be included. In the event Baxter fails to meet such EY on average for Batches Produced in the first quarter after which EY was determined, provided such Presentation of Product was Produced in such quarter, BAXTER will deliver on average during any calendar quarter thereafter not less than such mutually agreed upon EY for each Presentation of Product for all Batches Released during such quarter, provided a minimum of [***] ([***]) such Batches have been Released for each Presentation, including all Units Released by BAXTER, samples consumed by BAXTER for release testing, samples shipped for AMYLIN release and stability testing, and any retention samples. If [***] ([***]) Batches of each Presentation of Product were not Released in such calendar quarter, the reconciliation process described herein will be performed when the [***] ([***]) such Batch, following the most recent reconciliation, is Released and invoiced by BAXTER. In the event that BAXTER delivers, on average, an actual yield (“AY”) for Batches Released in any calendar quarter which is lower than EY set out above, at the end of such calendar quarter, Baxter will reimburse AMYLIN according to the following formula: [***]; provided, however, such amount shall not exceed [***] percent ([***]%) of the Purchase Price of such Presentation of Product purchased by AMYLIN in such calendar quarter, or applicable time period. If the actual yield is low due to additional sampling, testing, technical transfer, stability, or AMYLIN requested samples for a given Batch, such Batch will not be included in the quarterly calculation and BAXTER will not reimburse AMYLIN for such deficit. The foregoing represents the sole liability of BAXTER and the sole and exclusive remedy of AMYLIN for yield shortfall.