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 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. 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 in accordance with the terms of this Agreement.
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 * CONFIDENTIAL TREATMENT REQUESTED. OMITTED PORTIONS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. 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. 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.
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. HOVIONE shall successfully complete [***] full-scale engineering batches of CAPTISOL prior to [***]. Each such batch shall yield a minimum of [***] Kg of CAPTISOL to be an acceptable engineering batch. HOVIONE shall not commence engineering batches until CYDEX has approved, with respect to the equipment necessary for the manufacture of CAPTISOL, (i) HOVIONE’s installation of such equipment (by inspection), (ii) the design qualification report for such equipment, (iii) the installation qualification report for such equipment, and (iv) the operational qualification report for such equipment. Engineering batches shall be manufactured in accordance with cGMP but shall not be required to meet the SPECIFICATIONS. The sole purpose of engineering batches is to detect deficiencies in the production line and to adjust the process parameters.
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 or as requested by CLIENT, and agreed to by LONZA. Any Engineering Batch that meets the criteria set forth in the applicable Statement of Work, shall be deemed to be a successful Engineering Batch for purposes of Section 5.2. CLIENT shall have the right to make whatever further use of Engineering Batches that are not cGMP Batches as it shall determine in its sole discretion, 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. If LONZA determines that an Engineering Batch does meet cGMP and the Specifications, it will release such Engineering Batch as a cGMP Batch. Unless an SOW specifically provides otherwise, Engineering Batches manufactured in accordance with this Section 5.1 shall be part of the Campaign during which they are manufactured and CLIENT shall pay LONZA for such Engineering Batches in accordance with Section 9.2 (regardless of whether such Engineering Batch meets cGMP or the Specifications).
