Engineering Batches Sample Clauses

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. 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, 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. 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. 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).

Engineering Batches. It is agreed that Lonza shall manufacture [*] Engineering Batches at the Visp Facility prior to the commencement of Process Validation Batches, or such fewer number as shall be agreed by the Parties. Lonza shall manufacture Engineering Batches in accordance with the applicable Stage of Work and in compliance with cGMP. Lonza shall test each Engineering Batch against the Specification but Lonza shall not have any obligation to achieve the Specifications (and such results may not be used to reject a Batch). Customer shall pay for each of the Engineering Batches, unless [*] for a particular Engineering Batch(es), in which case Customer would not have to pay for such Engineering Batch(es). An Engineering Batch may only be rescheduled in accordance with Clause 7.4. Customer shall have the right to make whatever use of any Engineering Batches as it shall determine in compliance with Applicable Laws, provided that Customer shall not use any Engineering Batches for human use unless the Engineering Batch is found to meet Specifications and to have been made in accordance with cGMP and such use is also permissible under Applicable Laws. Lonza makes no warranty that Engineering Batches will meet Specifications; provided that Process Validation Batches shall not commence until it is demonstrated that the Manufacturing Process can produce Product that meets the Specifications (and the Target Yield as provided in Clause 2.4.2). If an Engineering Batch is found to meet the Specifications and to have been made in accordance with cGMP, Lonza may Release such Engineering Batch as cGMP Product upon prior written consent from Customer and all warranties applicable to cGMP Product shall thereafter apply to such Batch of Product. Customer shall pay to Lonza the Price for all Engineering Batches at the applicable Price set forth in Clause 9.1, plus the Raw Materials Fee associated with Engineering Batches. For clarity, Customer [*] = Certain confidential information contained in this document, marked by brackets, is omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. shall not be required to make any additional payment to Lonza for its technology transfer of the Manufacturing Process from Lonza’s Porrino Facility to the Visp Facility. In respect of such Engineering Batches, Customer shall be required to pay the Raw Materials Fee, shipping costs, the costs of any External Laboratories. If additional Engineering Batches are re...

Engineering Batches. Lonza shall manufacture Engineering Batches in accordance with the applicable Purchase Order. Radius shall have the right to make whatever further use of the non-cGMP Engineering Batches as it shall determine, provided that Radius 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, Radius 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 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 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 relevant Statement of Work. Both Parties shall discuss and agree on the price for each Engineering Batch. LONZA shall use commercially reasonable efforts to minimize the number of Engineering Batches that it needs to manufacture prior to the manufacturing of cGMP Batches set forth in Section 2.6. CLIENT shall have the right to make whatever further use of the Engineering Batches as it shall determine, provided that CLIENT pays for such Batches at a price mutually agreed to between the Parties in writing and such use is not for human use, and upon such payment, all right and title to, and interest in, the Engineering Batch shall be transferred from LONZA to CLIENT. 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, for which CLIENT has not previously paid. In the event that CLIENT does not use the Engineering Batches, LONZA shall dispose of such Engineering Batches according to LONZA’s standard procedure at its own expense.