Common use of Engineering Batches Clause in Contracts

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 purposes It is agreed that Lonza shall manufacture [*] Engineering Batches at the Visp Facility prior to the commencement of this AgreementProcess Validation Batches, an “or such fewer number as shall be agreed by the Parties. Lonza shall manufacture Engineering Batch” means a Batch that is not specified in the applicable Statement of Work or Purchase Order for Manufacture Batches in accordance with GMP. Provider will Manufacture Engineering Batches as provided in the applicable Statement Stage of WorkWork and in compliance with cGMP. There will 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 no acceptance criteria or other specifications used to reject a Batch). Customer shall pay for purposes each of acceptance of the Engineering Batches, but the Parties may agree on certain target quality attributes unless [*] for a particular Engineering Batch(es), 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 which case Customer would not have to Senti. Provided Senti makes written request in advance of the applicable Manufacturing run and reimburses Provider pay for all costs of shipping of the Engineering Batch, such Engineering Batches will Batch(es). An Engineering Batch may only be provided to Senti subject to compliance rescheduled in accordance with applicable regulatory requirementsClause 7.4. Senti will Customer shall have the right to make whatever further use of such 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 determinemeet Specifications; provided that such use does Process Validation Batches shall not violate any Lawscommence 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 does not is found to 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 Specifications 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 have been made in accordance with the Manufacturing Process or agreed protocolscGMP, or equipment failure, Provider will repeat the Manufacture of Lonza may Release such Engineering Batch as soon as practicablecGMP 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, at Providerplus 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 expensePorrino 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 required pursuant to Clause 2.4.3 then the provisions of Clause 2.4 shall apply to such additional Engineering Batches.