Manufacturing Assumptions Sample Clauses
The Manufacturing Assumptions clause defines the baseline conditions and expectations regarding the production process for goods under the contract. It typically outlines key factors such as production rates, material specifications, lead times, and quality standards that both parties agree will be used for planning and pricing. For example, it may specify that certain components will be sourced from approved suppliers or that production will occur at a designated facility. This clause ensures that both parties have a shared understanding of the underlying assumptions used to calculate costs and timelines, thereby reducing the risk of disputes if actual manufacturing conditions differ from those anticipated.
POPULAR SAMPLE Copied 1 times
Manufacturing Assumptions. The manufacturing process at Patheon will follow the process information provided by Client and Patheon's best estimates.
Manufacturing Assumptions. The commercial process at Patheon will closely follow the manufacturing information provided by Reliant.
Manufacturing Assumptions. The manufacturing process at Patheon will follow the process information provided by Pozen and Patheon’s experience with the product. · The core tablet weight and manufacturing batch sizes for each strength proposed by Patheon are summarized in the following table. · Pricing for both a 503 and 1250Kg batch size is being presented for comparison purposes. · *** for *** and *** are *** on ***. · It is *** that the *** would only be required to *** of the ***. *** can fully *** and this *** can be ***. · It is *** that *** are *** and ***. · Each *** has *** to the ***. · *** has been included on the finished product. · *** may be subject to change after the *** on *** and ***. · It is *** that *** are *** and *** after each campaign. The following cost items are included in the Price for the Products: *** and *** ***of *** ***of *** *** *** for *** ***, and *** thereafter CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION *** and *** *** of the *** *** and *** *** *** of *** and other *** for *** *** of *** and other *** for *** or *** *** *** and *** of *** and *** *** of *** and *** for *** *** and *** by *** to be *** by *** and***.
Manufacturing Assumptions. Patheon will use the following manufacturing equipment train in the Manufacturing Process and for production of the TIMERxâ-N Product. [**] • There will be [**]. Final blending will be performed in the [**]. • Single Batch manufacturing runs are anticipated. Each Batch will yield approximately [**] kilograms of TIMERxâ-N. • Patheon assumes that the TIMERxâ-N Formulation does not absorb/adsorb to any metal, glass or other components used during the processing and analytical testing of the Batch. • Patheon assumes the current cleaning procedure is adequate and full cleaning occurs after each campaign. • A manufacturing yield of [**] percent ([**]%) is expected based on Penwest’s prior experience with the Manufacturing Process. • Patheon shall conduct finished Product testing on all Product Batches, in accordance with the Manufacturing Process, cGMPs and Specifications, such testing to include: [**]. • As per Penwest, granulation will be bulk packaged into approximately [**] drums double lined with [**].
Manufacturing Assumptions. The manufacturing process at Patheon will closely follow the process information provided by Salix and work performed to-date at the site.
Manufacturing Assumptions. 1. The manufacturing process at Patheon will closely follow the process information provided by Depomed and experience to-date at the site.
Manufacturing Assumptions. 1.1 The manufacturing process at Patheon will closely follow the process information provided by Client.
1.2 The core weight for the tablets and the manufacturing batch size proposed by Patheon are summarized in the following table. [***] [***] [***] [***] [***] [***]
1.3 The following manufacturing equipment train is proposed for Rolapitant P407 Tablets. [***] [***] [***] [***] [***] [***]
2.1. Rolapitant tablets will be packaged into the configuration listed below. [***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
2.3. The following packaging equipment train is proposed for Rolapitant P407 Tablets [***] [***]
3.1. Listed in the table below are the tests for raw materials, packaging components and finished product. Bulk Tablets [***] [***] [***] [***] [***] [***] [***] Finished Product [***]
3.2. It is assumed that the Patheon would only be required to complete [***] testing of the API. Patheon can fully test incoming API and this service can be included if requested. 3.3. It is assumed that QC test methods are fully validated and robust.
Manufacturing Assumptions. The manufacturing process at Patheon will closely follow the process information provided by Supernus and Patheon’s best estimates.