Engineering Batches. Lonza 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 makes no warranty that Engineering Batches will meet cGMP or the Specifications. If Lonza 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 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 shall bear the costs of replacing the Batch, the Raw Materials and Customer Materials for any replacement Engineering Batch. For each CRM12 batch, the Raw Materials liability may be up to a maximum amount of [***]. For each bioconjugate batch, the Raw Materials liability (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 [***].
Engineering Batches. Lonza shall manufacture Engineering Batches as necessary 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 makes no warranty that Engineering Batches will meet cGMP or the Specifications. If Lonza 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 the Price for such Engineering Batch plus the Raw Materials Fee associated with such Engineering Batches.
Engineering Batches. Lonza shall manufacture Engineering Batches in accordance with the Project Plan, the other applicable terms of this Agreement and the Quality Agreement. Forty Seven shall have the right to make whatever further use of the non-cGMP Engineering Batches as it shall determine, provided that Forty Seven pays for any such Batches manufactured in accordance with this Section 2.2 at the rate set forth in Clause 8.1, such use is not for human use and does not violate any Applicable Laws. Lonza makes no warranty that Engineering Batches will meet CGMP and Specifications, but Lonza will use commercially reasonable efforts to meet CGMP and Specifications with respect to each Engineering Batch. If Lonza 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, Forty Seven shall pay to Lonza the Price for such Engineering Batch plus the Raw Materials Fee associated with such Engineering Batches.
Engineering Batches. Lonza shall manufacture Engineering Batches in accordance with the Project Plan(s) and batch records. 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. While Lonza makes absolutely no warranty that Engineering Batches will meet cGMP or the Specifications, Lonza will manufacture the Engineering Batches under cGMP conditions. Accordingly, if Lonza 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 and provided that the Engineering Batch was executed in accordance with the Project Plan and batch records, Customer shall pay to Lonza the Price for such Engineering Batch plus the Raw Materials Fee associated with such Engineering Batch. In the event Customer requests a material change to the Manufacturing Process or Specifications, Lonza and Customer shall discuss in good faith modifications and written amendments to the applicable Project Plan, including potential manufacture of additional Engineering Batches utilizing the modified process or specifications and adjustments (up or down) to Batch Price to reflect changes in cost resulting from such material change.
Engineering Batches. For purposes of this Agreement, an “Engineering Batch” means a Batch that is not specified in the applicable Statement of Work or Purchase Order for Manufacture in accordance with GMP. Provider will Manufacture Engineering Batches as provided in the applicable Statement of Work. There will be no acceptance criteria or other specifications for purposes of acceptance of Engineering Batches, but the Parties may agree on certain target quality attributes in the applicable Statement of Work. Provider will provide analytical testing of Engineering Batches as agreed by the Parties in the applicable Statement of Work and will report the results to Senti. Provided Senti makes written request in advance of the applicable Manufacturing run and reimburses Provider for all costs of shipping of the Engineering Batch, such Engineering Batches will be provided to Senti subject to compliance with applicable regulatory requirements. Senti will have the right to make whatever further use of such Engineering Batches as it will determine; provided that such use does not violate any Laws. If [***] Engineering Batch [***] such results [***], provided, however, that if the Engineering Batch is [***], Provider will [***].
Engineering Batches. LONZA shall manufacture Engineering Batches in accordance with the Statement of Work. CLIENT shall have the right to make whatever further use of the non-cGMP Engineering Batches as it shall determine, provided that CLIENT pays for such Batches, such use is not for human use and does not violate any applicable laws. [***]. Whether or not a given Engineering Batch will be run using cGMP protocols will be mutually agreed to by the Parties in advance and set forth in each given SOW ([***]). If LONZA determines that an Engineering Batch does meet cGMP and the Specifications, it will release such Engineering Batch as a cGMP Batch. Regardless of [***], CLIENT shall [***].
Engineering Batches. LONZA shall manufacture Engineering Batches in accordance with the Statement of Work. CLIENT shall have the right to make whatever further use of the non-cGMP Engineering Batches as it shall determine, provided that CLIENT pays for such Batches, such use is not for human use and does not violate any applicable laws. LONZA makes no warranty that Engineering Batches will meet cGMP or the Specifications. Regardless of whether any Engineering Batch meets cGMP or the Specifications, CLIENT shall pay to Lonza the price for such Engineering Batch plus the cost of any materials and any materials handling fee associated with such Engineering Batches that are specified in the applicable Statement of Work.
Engineering Batches. Lonza shall manufacture, and Customer shall pay for, 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 makes no warranty that Engineering Batches will meet cGMP or the Specifications. If Lonza determines that an Engineering Batch does meet cGMP and the Specifications, it will release such Engineering Batch as a cGMP Batch. Nothing in this Clause 2.3 shall be construed to limit Customer’s remedies set forth in Clause 7.3.3. Notwithstanding anything to the contrary, no Engineering Batches shall commence until Lonza has completed a Pilot Batch at the Facility. 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 the consequences of such changes.
Engineering Batches. The Annual Order that Altus shall submit by [***] (for delivery in [***]) shall include a binding order for [***] engineering Batch of each Bulk Product Component, and Lonza shall manufacture and supply to Altus such engineering Batches in accordance with this Agreement. However, for the avoidance of doubt, Lonza will be under no obligation to meet the Bulk Specifications for such engineering Batches, but Lonza agrees to [***] [***] such Bulk Specifications. If any such engineering Batch for a particular Bulk Product Component has [***] (e.g., [***]), then at Altus' request Lonza shall manufacture and supply to Altus another engineering Batch in accordance with this Agreement for such Bulk Product Component, at Altus' cost. Lonza may elect, at their sole discretion, to manufacture and supply to Altus further engineering Batch(es) in accordance with this Agreement for such Bulk Product Component, which manufacturing and supply will be at [***].
Engineering Batches. Lonza shall manufacture Engineering Batches in accordance with the master batch record. Vaxcyte shall have the right to make whatever further use of the non-cGMP Engineering Batches as it shall determine, provided that, such use is not for human use and does not violate any Applicable Laws. [***], Lonza will manufacture the Engineering Batches under cGMP conditions. Accordingly, if Lonza determines that an Engineering Batch does meet cGMP and the Specifications, it will release such Engineering Batch as a cGMP Batch.
