Quality Matters. (a) As soon as possible following execution of this Agreement and in any case prior to commencement of cGMP activity (including production of [***]), [***] (b) aTyr may carry out an annual audit of Fujifilm in accordance with the provisions of the Quality Agreement. Additional audits (other than “for cause” audits) may be carried out subject to payment of Fujifilm’s reasonable costs and expenses and subject to a commercial rate to be agreed. (c) If during Disposition, or during a period of [***] days thereafter, it is ascertained by either Party that a GMP Batch produced during the Manufacturing Stage is a Non-Conforming Batch then the following provisions shall apply: (i) Either Party shall promptly notify the other Party in writing, but in no event later than [***] calendar days, after the discovery of a Non-Conforming Batch [***] Fujifilm shall have [***] calendar days after delivery of a [***] to investigate, and then notify aTyr in writing as to whether the corresponding Non-Conforming Batch resulted in whole or in part from a [***] If aTyr and Fujifilm fail to agree within [***] business days following Fujifilm’s notice to aTyr regarding whether the Non-Conforming Batch was due to a [***], the Parties shall resolve the dispute pursuant to [***] No payments for disputed invoices for the applicable Manufacturing Stage and Scope of Work shall be due to Fujifilm until the resolution of the dispute. (ii) Any Non-Conforming Batch shall [***] (iii) The following provisions shall apply if after the investigation, both Parties agree that the Non-Conforming Batch did not arise as a result of a Fujifilm Factor: (1) [***] (2) [***] (3) [***] (iv) [***]: The following provisions shall apply if after the investigation, both Parties agree, or it is determined following independent testing in accordance with [***] that the Non-Conforming Batch arose as a result of a [***]: (1) [***] (2) [***]
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Quality Matters. (a) As soon as possible following execution of this Agreement and in any case prior to commencement of cGMP activity (including production of [***]Cell Banks), [***]the Parties shall execute the Quality Agreement. Each Party shall fulfil its responsibilities as set out in the Quality Agreement.
(b) aTyr may carry out an annual audit of Fujifilm in accordance with the provisions of the Quality Agreement. Additional audits (other than “for cause” audits) may be carried out subject to payment of Fujifilm’s reasonable costs and expenses and subject to a commercial rate to be agreed.
(c) If during Disposition, or during a period of [***] days thereafter, it is ascertained by either Party that a GMP Batch produced during the Manufacturing Stage is a Non-Conforming Batch then the following provisions shall apply:: * Confidential Information, indicated by [***], has been omitted from this filing and filed separately with the Securities and Exchange Commission
(i) Either Party shall promptly notify the other Party in writing, but in no event later than [***] calendar days, after the discovery of a Non-Conforming Batch [***] (“Non-Conforming Batch Notice”). Fujifilm shall have [***] calendar days after delivery of a [***] Non-Conforming Batch Notice to investigate, and then notify aTyr in writing as to whether the corresponding Non-Conforming Batch resulted in whole or in part from a [***] Fujifilm Factor. If aTyr and Fujifilm fail to agree within [***] business days following Fujifilm’s notice to aTyr regarding whether the Non-Conforming Batch was due to a [***]Fujifilm Factor, the Parties shall resolve the dispute pursuant to [***] No payments for disputed invoices for the applicable Manufacturing Stage and Scope of Work shall be due to Fujifilm until the resolution of the dispute.
(ii) Any Non-Conforming Batch shall [***]
(iii) The following provisions shall apply if after the investigation, both Parties agree that the Non-Conforming Batch did not arise as a result of a Fujifilm Factor:
(1) [***]
(2) [***]
(3) [***]
(iv) [***]: The following provisions shall apply if after the investigation, both Parties agree, or it is determined following independent testing in accordance with [***] that the Non-Conforming Batch arose as a result of a [***]:
(1) [***]
(2) [***]
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