Yield Loss Percentage Methodology Sample Clauses

Yield Loss Percentage Methodology. The yield for each batch of product manufactured will be calculated using the following equation: Yield (%) = (Actual Number of Units ·/· Theoretical Number of Units) x 100 where, Actual Number of Units = the total number of units obtained from the lyophilization chamber. This reflects the actual number of vials that are directly obtained after unloading the lyophilization chamber. Samples including without limitation for release testing, stability studies and extra samples for other purposes shall account for the actual Number of Units. Theoretical Number of Units = ***. This is the theoretical number of ***representing a full ***. In the beginning of the Paclical project BXXXXX will start with a compounding volume of ***in order to ensure a full load of a lyophilizer. This compounding volume maybe adapted after the first batches when BXXXXX has gained enough experience with regard to losses during compounding and filling. If the yield of the produced batches is *** the methodology as described in the COMMERCIAL MANUFACTURING AND SUPPLY AGREEMENT shall be applied. If manufacturing times, volumes, or processes should change in the future, the impact of those changes on the theoretical number of units will be evaluated with respect to batch yield calculations. [***] INDICATES CONFIDENTIAL PORTION HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT AND HAS BEEN FILED SEPARATELY WITH THE COMMISSION 8 Shipping Responsibilities The Product will be manufactured at BXXXXX and shipped to OASMIA as a bulk product (no secondary packaging at BXXXXX will be performed). All shipping activities will be done under ***. OASMIA will be responsible to assign the shipments with an international forwarding company and to organize the transportation from BXXXXX to the company in [EU/US (alternative)] specified by OASMIA, which conducts or arranges the final packaging and labeling activities. BXXXXX will support these activities with information to the forwarding company and preparation of the products for transportation.
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