cGMP Batches. Lonza will, in accordance with the terms of this Agreement and Quality Agreement, manufacture at the Facility and Release to Customer, cGMP Batches that comply with the Manufacturing Process, cGMP and the Specifications, together with a Certificate of Analysis; provided, however, that cGMP manufacture shall not commence until at least [***] has been manufactured in compliance with cGMP and Specifications. 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. For each CRM12 batch, the Raw
(i) during storage of each bioconjugate batch is limited to [***], (ii) for manufacturing of each bioconjugate batch is limited to [***] and (iii) per manufacturing campaign is limited to [***]. Prior to commencement of cGMP manufacturing, Lonza shall review the process assumptions. In the event that there is a material difference in the process assumptions as compared with the process results demonstrated during the manufacture of Engineering Batches, the Parties shall meet to discuss in good faith a revision to the Batch Price to reflect such difference.
cGMP Batches. Lonza will, in accordance with the terms of this Agreement and Quality Agreement, manufacture at the Facility and Release to Customer, cGMP Batches that comply with the Manufacturing Process, cGMP and the Specifications, together with a Certificate of Analysis.
cGMP Batches. Lonza will, in accordance with the terms of this Agreement and Quality Agreement, manufacture at the Facility and Release to Customer, cGMP Batches that comply with the Manufacturing Process, cGMP and the Specifications, together with a Certificate of Analysis; provided, however, that cGMP manufacture shall not commence until at least [***] has been manufactured in compliance with the Specifications. Prior to commencement of cGMP manufacturing, Lonza shall review the process assumptions. In the event that there is a material difference in the process assumptions as compared with the process results demonstrated during the manufacture of the Technical Batches, the Parties shall meet to discuss in good faith a revision to the Batch Price to reflect such difference.
cGMP Batches. Lonza will, in accordance with the terms of this Agreement and the Quality Agreement, manufacture at the Facility and Release to Customer, cGMP Batches that comply with the Manufacturing Process, cGMP and the Specifications, together with a Certificate of Analysis; provided, however, that cGMP manufacture shall not commence until at least one (1) successful Engineering Batch has been manufactured in compliance with cGMP and Specifications. Prior to commencement of cGMP manufacturing, Lonza shall review the process assumptions. In the event that there is a material difference in the process assumptions as compared with the process results demonstrated during the manufacture of Engineering Batches, the Parties shall meet to discuss in good faith a revision to the Batch Price to reflect such difference.
cGMP Batches. Lonza will, in accordance with the terms of this Agreement and Quality Agreement, manufacture at the Facility and release to Forty Seven, cGMP Batches that comply with the Manufacturing Process, cGMP and the Specifications, together with a Certificate of Analysis (such manufacture, “cGMP manufacture”); provided, however, that (i) Lonza is not obligated to commence cGMP manufacture until at least [*] has been manufactured in compliance with cGMP and Specifications and (ii) after any change in the process for such Product agreed to or requested by Forty Seven, Lonza shall not be obligated to recommence cGMP manufacture until at least [*] has been manufactured in compliance with cGMP and Specifications. Prior to commencement of cGMP manufacturing, Lonza shall review the process assumptions. In the event that there is a material difference in the process assumptions as compared with the process results demonstrated during the manufacture of Engineering Batches, the Parties shall meet to discuss in good faith a revision to the Batch Price to reflect such difference.
cGMP Batches. Lonza will, in accordance with the terms of this Agreement and Quality Agreement, manufacture at the Facility and Release to Customer, cGMP Batches that comply with the Manufacturing Process, cGMP and the Specifications, together with a Certificate of Analysis; provided, however, that cGMP manufacture shall not commence until at least [***] has been manufactured in compliance with the Specifications. Lonza will replace any cGMP Batch that does not meet the Specifications and will compensate Customer for Raw Materials and lost Customer Material (e.g. Antigens) in such a batch in accordance with clause 7.3.
cGMP Batches. With respect to the cGMP Batches of Product manufactured, it is agreed that Lonza shall manufacture the cGMP Batches of Product to meet the Specification provided that there shall be no obligation (other than to use commercially reasonable efforts) to meet the Specification in respect of the first [*] cGMP Batches of Product manufactured, or in respect of the first [*] cGMP Batches of Product manufactured following any change in the process for such Product agreed to or requested by Forty Seven.
cGMP Batches. Lonza shall manufacture cGMP Batches to meet the Specification; [Redacted] Lonza will not make any changes to the Master Batch Record, Specifications, Process, Raw Materials or any other item related to the Product(s) or their manufacture without [Redacted] obtaining Customer’s prior written approval.
cGMP Batches. Lonza will, in accordance with the terms of this Agreement and Quality Agreement, manufacture at the Facility and Release to Radius, cGMP Batches that comply with the Manufacturing Process, cGMP and the Specifications, together with a Certificate of Analysis; provided, however, that [*] cGMP manufacture [*] shall not commence until at least [*] successful [*] been manufactured in compliance with cGMP and Specifications [*]. Prior to commencement of cGMP manufacturing, Lonza shall review the process assumptions. In the event that there is a material difference in the process assumptions as compared with the process results demonstrated during the manufacture of Engineering Batches, the Parties shall meet to discuss in good faith a revision to the Batch Price to reflect such difference.
cGMP Batches. LONZA will, in accordance with the terms of this Agreement and Quality Agreement, manufacture at the Facility and release to CLIENT, cGMP Batches that comply with the Process, cGMP and the Specifications, together with a certificate of analysis; [***]. Prior to commencement of cGMP manufacturing, LONZA shall review the process assumptions. In the event that there is a material difference in the process assumptions as compared with the process results demonstrated during the manufacture of Engineering Batches, the Parties shall meet to discuss in good faith a revision to the Batch price to reflect such difference.
