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.
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Samples: Services Agreement (Sciclone Pharmaceuticals Inc), Services Agreement (Sciclone Pharmaceuticals Inc)
cGMP Batches. Lonza will, in accordance with the terms of this Agreement and the Quality Agreement, manufacture at the Facility and Release release to Customer, cGMP Batches that comply with the Manufacturing Process, the Quality Agreement, cGMP and the Specifications, together with a Certificate of Analysis; provided, however, that cGMP manufacture shall not commence until at least […***…]. Prior to commencement of cGMP manufacturing, the Parties shall jointly review the process assumptions.
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Samples: Manufacturing Agreement (Tracon Pharmaceuticals, Inc.)
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. [***].
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Samples: Letter Agreement (Vaxcyte, Inc.)
cGMP Batches. Lonza will, in accordance with the terms of this Agreement and Quality Agreement, manufacture at the Facility and Release release to Customer, cGMP Batches that comply with the Manufacturing 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, [***].
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