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 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. 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 an Engineering Batch does not meet the target quality attributes set forth in the applicable Statement of Work (an “Unsatisfactory Engineering Batch”), such results do not relieve Senti’s obligation of payment for the Batch Price and Out-of-Pocket Costs for such Engineering Batch, provided, however, that if the Engineering Batch is compromised due to the negligence or willful misconduct of Provider, Provider’s failure to Manufacture such Engineering Batch in accordance with the Manufacturing Process or agreed protocols, or equipment failure, Provider will repeat the Manufacture of such Engineering Batch as soon as practicable, at Provider’s expense.

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. 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 Engineering Batches in accordance with the applicable 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 in accordance with the Statement of Work, 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 as contemplated in the applicable Statement of Work.

Engineering Batches. If requested and agreed between the Parties LONZA shall manufacture Engineering Batches in accordance with the Agreement and Applicable Law. GAMIDA shall have the right to make whatever further use of the non-cGMP Engineering Batches as it shall determine, such use is not for human use and does not violate any Applicable Law. [*]. The expenses relating to any Engineering Batch manufactured in connection with the preparation of a new Suite will be covered by the payment due (if any) with respect to the activation of such new Suite and any Engineering Batch manufactured thereafter shall be covered as one of the Batches manufactured in the particular Suite. The Parties will discuss whether Engineering Batches will be required for any new Suites.

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.

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.