Common use of Engineering Batches Clause in Contracts

Engineering Batches. For any Engineering Batch(es) required to be manufactured pursuant to a SOW, Lonza shall manufacture such Engineering Batch(es) in accordance with the terms of this Agreement and applicable SOW, but shall have no obligation to meet Specifications or comply with cGMP in relation to the Engineering Batch (and Lonza makes no warranty in this regard). Notwithstanding the foregoing, Lonza shall be obligated to execute each Engineering Batch in accordance with the engineering Batch Record and to use commercially reasonable efforts to meet the acceptance criteria mutually agreed in advance by the Parties, at set forth in the SOW, for the particular Engineering Batch. Further, Lonza will provide a Certificate of Testing for all Engineering Batch(es) containing all agreed upon testing for the Customer to provide in submissions to Regulatory Authorities. If Lonza determines that an Engineering Batch does meet cGMP and the Specifications, it may, subject to Customer’s agreement in its sole discretion, release such Engineering Batch as a cGMP Batch. The Price of the Engineering Batch as set forth in the applicable SOW shall apply regardless of whether released as a cGMP Batch. Customer shall pay to Lonza the Price for such Engineering Batch(es) plus the Raw Materials, testing and Handling Fee(s) associated with such Engineering Batch(es) as set forth in the SOW, unless Lonza or its Affiliates or Subcontractors were grossly negligent, or committed willful misconduct, causing an Engineering Batch to fail to meet the applicable mutually agreed acceptance criteria set forth in advance by the Parties. If it is determined by the Parties or a mutually agreed upon independent laboratory determines Lonza or its Affiliates or Subcontractors were grossly negligent, or committed willful misconduct in the manufacture of any Engineering Batches, causing such Engineering Batch to fail to meet mutually agreed acceptance criteria set forth in advance in writing by the Parties, such Batch shall be treated as a Failed Batch under Section 7.4.3. Customer shall have the right to make whatever use of released cGMP and non-cGMP Engineering Batch(es) at its discretion so long as such use does not violate any Applicable Laws. However, Engineering Batches not released as cGMP are not for human use.

Engineering Batches. For any Engineering Batch(es) required to be manufactured pursuant to a SOW, 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 Batch(es) Batches in accordance with the terms applicable Stage of this Agreement Work and applicable SOW, but shall have no obligation to meet Specifications or comply in compliance with cGMP in relation to the Engineering Batch (and Lonza makes no warranty in this regard)cGMP. Notwithstanding the foregoing, Lonza shall be obligated to execute test each Engineering Batch in accordance with against the engineering Batch Record Specification but Lonza shall not have any obligation to achieve the Specifications (and such results may not be used to use commercially reasonable efforts to meet the acceptance criteria mutually agreed in advance by the Parties, at set forth in the SOW, for the particular Engineering reject a Batch. Further, Lonza will provide a Certificate of Testing for all Engineering Batch(es) containing all agreed upon testing for the Customer to provide in submissions to Regulatory Authorities. If Lonza determines that an Engineering Batch does meet cGMP and the Specifications, it may, subject to Customer’s agreement in its sole discretion, release such Engineering Batch as a cGMP Batch. The Price of the Engineering Batch as set forth in the applicable SOW shall apply regardless of whether released as a cGMP 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 Lonza the Price pay for such Engineering Batch(es) plus the Raw Materials, testing and Handling Fee(s) associated with such Engineering Batch(es) as set forth in the SOW, unless Lonza or its Affiliates or Subcontractors were grossly negligent, or committed willful misconduct, causing an ). An Engineering Batch to fail to meet the applicable mutually agreed acceptance criteria set forth may only be rescheduled in advance by the Parties. If it is determined by the Parties or a mutually agreed upon independent laboratory determines Lonza or its Affiliates or Subcontractors were grossly negligent, or committed willful misconduct in the manufacture of any Engineering Batches, causing such Engineering Batch to fail to meet mutually agreed acceptance criteria set forth in advance in writing by the Parties, such Batch shall be treated as a Failed Batch under Section 7.4.3accordance with Clause 7.4. Customer shall have the right to make whatever use of released 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 non-cGMP Engineering Batch(es) at its discretion so long as such use does not violate any is also permissible under Applicable Laws. However, Lonza makes no warranty that Engineering Batches will meet Specifications; provided that Process Validation Batches shall not released 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 not for human userequired pursuant to Clause 2.4.3 then the provisions of Clause 2.4 shall apply to such additional Engineering Batches.