cGMP Batch definition

cGMP Batch means a Batch that is stipulated in the Work Statement to be manufactured according to cGMP.

cGMP Batch means any Batch which is required under the Statement of Work to be manufactured in accordance with cGMP.

cGMP Batch means a Batch that is stipulated in the Work Statement to be manufactured according to cGMP. “cGMP Product” means Product manufactured under a cGMP Batch.

Examples of cGMP Batch in a sentence

• If Lonza determines that an Engineering Batch does meet cGMP and the Specifications, it will release such Engineering Batch as a cGMP Batch.

• Lonza will bear the risk of replacing any Raw Materials or Customer Materials that were consumed in any cGMP Batch that does not meet the Specifications and is not released to Customer, and after [***], Lonza will bear the risk of replacing any Batch that does not meet the Specifications.

• Xencor shall in good faith have the right to reject any Delivery if (i) a Batch does not meet the mutually agreed Specifications; or (ii) a cGMP Batch was not actually Processed in accordance with cGMPs or relevant FDA guidance documents.

• In addition, Forty Seven may refer potential Third Party customers to Lonza in respect of any such excess Assigned Capacity and/or Additional cGMP Batch Capacity, provided that Lonza shall at all times have the sole and absolute discretion whether or not it decides to enter into discussions with such referred Third Party customers.

• This Agreement shall commence on the Effective Date and shall end on the later of the completion of the final cGMP Batch to be manufactured within the Assigned Capacity or the fourth (4th) anniversary of the Effective Date in 2021 unless terminated earlier as provided herein or extended by mutual written consent of the Parties or otherwise in accordance with the terms of this Agreement (the “Term”).

More Definitions of cGMP Batch

cGMP Batch means a Batch that is required under the Scope of Work, the applicable Project Plan or a Purchase Order to be manufactured in compliance with cGMP.

cGMP Batch means a Batch required to be manufactured in accordance with CGMP.

cGMP Batch means a Batch of Product Produced from a cGMP production run conducted in accordance with the Master Batch Record that is used to create Product for research and development or for clinical use.

cGMP Batch means a Batch which is manufactured, or is stipulated in a Work Plan to be manufactured, according to cGMP; Certain confidential information contained in this document, marked by [**], has been omitted because the information (i) is not material and (ii) would likely cause competitive harm to the Company if publicly disclosed.

cGMP Batch a Batch identified in a Scope of Work which is intended to be manufactured during a Manufacturing Stage and subject to Disposition in each case in accordance with cGMP;

cGMP Batch means a Batch intended to be manufactured in accordance with cGMP.

cGMP Batch means a Batch which is manufactured, or is stipulated in a Work Plan to be manufactured, according to cGMP;