Yield for Commercial Product Sample Clauses

Yield for Commercial Product. Within thirty (30) calendar days from Xxxxxx’x release of the final process validation batch, Oasmia and Xxxxxx shall establish and mutually agree upon an appropriate number of units to be produced from the established volume of compounded bulk solution for Production of Commercial Product. The agreed upon number of units shall take into consideration losses of compounded bulk solution during Production of Commercial Product including without limitation loss in filter houses, and in-process-control samples to enable Xxxxxx to manufacture a full scale batch (***) (the “Yield Rate”). Pre-defined Commercial Product samples such as e.g. release samples, stability samples, etc. shall also be considered in the yield calculation. The Yield Rate shall be further defined in the Product Master Plan. Process validation batches will not be included in determining the Yield Rate. If the yield of a Batch of Commercial Product is at or above the Yield Rate, or below the Yield Rate due to an act or omission of Xxxxxx, the unit price for Commercial Product as set forth in the Product Master Plan will apply to the Units of Commercial Product in such Batch. If the yield of such Batch is below the Yield Rate due to a reason other than an act or omission of Xxxxxx, then the price of the Commercial Product will be based off of a batch price calculated using the average Yield Rate for Batches of Commercial Product Produced during the prior twelve (12) months, excluding any process validation batches. Notwithstanding the foregoing, if following the Production of the first five (5) Batches of Commercial Product the actual yield for such Batches is less than the expected Yield Rate, the parties shall meet to mutually agree upon an action plan which shall include a re-defining of the Yield Rate for the Production of future Batches of Commercial Product. Variation in yield shall not be looked upon as non-conforming, as long as the variation is within the limits acceptable by GMP’s. For the avoidance of doubt any loss due to non-conforming Product shall be handled in accordance with Section 7.2.1; no loss will be compensated under more than one such section.
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