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Engineering Batches
Engineering Batches contract clause examples

use of Demonstration Batches or Engineering Batches delivered to Atara hereunder;

Value Engineering. Tenant has the right to modify and/or “value engineer” the Space Plan before Landlord completes the Draft Working Drawings, as long as # Tenant provides its comments by December 22, 2017, time being of the essence, and # Landlord’s overall expected costs relating to the Tenant Improvements do not increase over $1,940,000 (the “Budget”) as a result. If Tenant’s proposed modifications will cause the expected cost of the work to run over Budget, the parties will work together in good faith to alter or delete the modifications, so that all of Landlord’s costs are brought within Budget.

Lonza will provide engineering management services to construct ​, a cGMP ​ Dedicated Suite in Lonza’s Pearland – 1 (PL-1) facility located at 14905 Kirby Drive, Pearland, TX 77047. ​ shall be sized to ensure adequate manufacturing of the Product as defined by the Process Flow Diagram in [Attachment 1]; the manufacturing shall be covered under a commercial supply Agreement. The clean room design and build out meets/will meet cGMP requirements of both FDA and EU Regulatory Authorities. Deliverables under this SOW will include:

Engineering Batches. [[Lonza:Organization]] shall manufacture Engineering Batches in accordance with the Project Plan. Customer shall have the- right to make whatever further use of the non-cGMP Engineering Batches as it shall determine, provided that Customer pays for such Batches, such use is not for human use and does not violate any Applicable Laws. [[Lonza:Organization]] makes no warranty that Engineering Batches will meet cGMP or the Specifications. If [[Lonza:Organization]] determines that an Engineering Batch does meet cGMP and the Specifications, it will release such Engineering Batch as a cGMP Batch. Regardless of whether any Engineering Batch meets cGMP or the Specifications, Customer shall pay to [[Lonza:Organization]] the Price for such Engineering Batch that were executed in accordance with mutually agreed plans and meet a mutually agreed specification for bioburden, plus the Raw Materials Fee associated with such Engineering Batches. If the Engineering Batch was not performed in accordance with mutually agreed plans or does not meet the agreed bioburden specification, then [[Lonza:Organization]] shall bear the costs of replacing the Batch, the Raw Materials and Customer Materials for any replacement Engineering Batch. For each [[Unknown Identifier]] batch, the Raw Materials liability may be up to a maximum amount of ​. For each bioconjugate batch, the Raw Materials liability # during storage of each bioconjugate batch is limited to ​, # for manufacturing of each bioconjugate batch is limited to ​ and # per manufacturing campaign is limited to ​.

FUJIFILM GIVES NO, AND DISCLAIMS ANY, WARRANTIES, UNDERTAKINGS OR SIMILAR TERMS WHATSOEVER IN RESPECT OF THE DEMONSTRATION BATCHES OR ENGINEERING BATCHES OR THE USE BY ATARA OF A DEMONSTRATION BATCH OR A DEMONSTRATION BATCH.

Engineering Documentation. Prior to distribution of the AgEagle System, AgEagle must supply to Raven, at a minimum, the following engineering documentation and design information that AgEagle has, can obtain from a third party, or can create from information on hand or obtained from a third party:

Where Product is manufactured by Patheon (or any of its Affiliates) under a separate pharmaceutical development or technology transfer agreement including that certain Umbrella Development Services Agreement between Client and Patheon API Services, Inc. effective as of November 15, 2018 (each agreement, the “Development Agreement”) and then released by Patheon for commercial sale or distribution by Client, the performance of the applicable pharmaceutical development or technology transfer services including the manufacture of the Product will be governed by the terms of the Development Agreement and will not be subject to the terms and conditions of this Agreement. The terms of this Agreement and the applicable Product Agreement will apply to any Product after release by Patheon.

Engineering Batches. [[Lonza:Organization]] shall manufacture Engineering Batches in accordance with the Project Plan. Customer shall have the- right to make whatever further use of the non-cGMP Engineering Batches as it shall determine, provided that Customer pays for such Batches, such use is not for human use and does not violate any Applicable Laws. [[Lonza:Organization]] makes no warranty that Engineering Batches will meet cGMP or the Specifications. If [[Lonza:Organization]] determines that an Engineering Batch does meet cGMP and the Specifications, it will release such Engineering Batch as a cGMP Batch. Regardless of whether any Engineering Batch meets cGMP or the Specifications, Customer shall pay to [[Lonza:Organization]] the Price for such Engineering Batch that were executed in accordance with mutually agreed plans and meet a mutually agreed specification for bioburden, plus the Raw Materials Fee associated with such Engineering Batches. If the Engineering Batch was not performed in accordance with mutually agreed plans or does not meet the agreed bioburden specification, then [[Lonza:Organization]] shall bear the costs of replacing the Batch, the Raw Materials and Customer Materials for any replacement Engineering Batch. For each [[Unknown Identifier]] batch, the Raw Materials liability may be up to a maximum amount of ​. For each bioconjugate batch, the Raw Materials liability # during storage of each bioconjugate batch is limited to ​, # for manufacturing of each bioconjugate batch is limited to ​ and # per manufacturing campaign is limited to ​.

Reverse Engineering. During the Term and for a period of ​ following the termination of this Agreement, Licensor hereby covenants and agrees that it shall not, and shall cause it Affiliates to not, for itself or themselves, # Develop, Commercialize or Manufacture in any country in the Territory, any Antibody or pharmaceutical product containing or encoding any Antibody, in each case that includes or contains an Antibody sequence provided by [[Organization A:Organization]] or its Affiliates to Licensor or its Affiliates hereunder, or # reverse engineer any Antibody or pharmaceutical product containing or encoding any Antibody, in each case that includes or contains an Antibody sequence provided by [[Organization A:Organization]] or its Affiliates to Licensor or its Affiliates hereunder.

​, FUJIFILM SHALL HAVE NO LIABILITY TO ATARA IN CONNECTION WITH DEMONSTRATION BATCHES OR ENGINEERING BATCHES OR THE USE BY ATARA OF THE DEMONSTRATION BATCHES OR ENGINEERING BATCHES.

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