Quality Matters. Since the Effective Date, neither the Seller nor any of its Affiliates shall have received any warning letters, notices to shut down or suspend any activities at any of the Transferred Facilities or similar notifications by any Governmental Authority, including the Medicines and Healthcare Products Regulatory Agency (MHRA), relating to the operations at the Transferred Facilities, the subject matter of which has not been subsequently remedied to the satisfaction of such Governmental Authority.
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) [***]
Quality Matters. C11480.A for subscription and services relating to faculty driven, peer review process for online and blended courses.
Quality Matters. Notwithstanding the provisions set forth in Section 6.1 above, amendments to the Quality Agreement relating to quality assurance or quality control shall be made in accordance with the applicable change control provisions set forth in the Quality Agreement.
Quality Matters. Promptly following the Execution Date, but in no event later than ninety (90) days thereafter, Almirall and Athenex will enter into an agreement governing the quality standards required under this Agreement, applicable Law or by Third Parties and quality data exchange procedures (including Third Parties performing manufacturing or testing activities) (the “Quality Agreement”). Such Quality Agreement shall describe the coordination of collection, investigation, reporting, and exchange of information concerning quality matters or any other quality issue related to the manufacturing and Commercialization of the Licensed Products in the Territory. The Quality Agreement exchange procedures will be updated from time to time or if required by changes in legal requirements. Upon its execution, the Quality Agreement will be attached as Schedule 3.5(d) hereto. Athenex will ensure that all manufacturing information and documentation related to batches included in the Regulatory Approvals is maintained for the Licensed Product lifetime. Almirall shall also have full access to the facilities utilized or contracted by Athenex to manufacture Licensed Product at least once a year for audit purposes. In particular, but not limited, an inspection ready audit in good time to prepare and review the actions plans, if necessary, of the Pre-Approval-Inspection (either in U.S and in Europe) related to NDA and MAA submission. Athenex will certify that all batches of the Licensed Product are manufactured in accordance to the Licensed Product requirements included in the Supply Agreement and that no changes in the manufacturing process will be implemented without Almirall’s prior written authorization
Quality Matters. As soon as possible following execution of this Agreement and in any case prior to commencement of cGMP activity, the Parties shall execute the Quality Agreement. Each Party shall fulfill its responsibilities as set forth in the Quality Agreement.
Quality Matters. Promptly following the POC Date, the parties shall negotiate in good faith a quality agreement (the “Quality Agreement”), with respect to the supply of Materials to Amgen as contemplated under the Supply Agreement, consistent with the terms set forth on the quality agreement term sheet set forth on Schedule 4.3(d) (the “Quality Agreement Term Sheet”). In the event that the JSC determines that Materials produced prior to the POC Date are reasonably likely to be supplied to Amgen for use after the POC Date, then, from the date of such determination until the earlier of (x) the execution of the Quality Agreement or (y) the termination of this Agreement in accordance with its terms, Amgen shall have the right to perform quality audits of Advaxis, or participate with Advaxis in its quality and/or facilities audit of its Third Parties utilized for sequencing, manufacturing, testing, disposition, storage, or transportation of Materials once per twelve (12) months period, or at any time in the event of a quality issue.
Quality Matters. Within ninety (90) days following the Effective Date, the parties will negotiate in good faith and enter into a quality agreement (the “Quality Agreement”) with respect to quality matters for the supply of Products as contemplated under the Supply Agreement.
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. In case of any conflict of the provisions set forth in the Quality Agreement and the provisions of this Agreement, this Agreement shall prevail to the extent of the conflict. Each Party shall fulfil its responsibilities as set out in the Quality Agreement.
(b) Checkmate may carry out an annual audit 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 costs and expenses and subject to a commercial rate to be agreed.
(c) Fujifilm Quality and Checkmate will review, approve and sign the Product Specification, the QC Document, the Process Specification and batch manufacturing records in each case generated by Fujifilm. During the GMP Manufacturing Stage and Disposition, Fujifilm Quality will inform Checkmate of any deviations and any out of specification reports within the period from discovery specified in the Quality Agreement. Any deviations determined to affect product quality will be identified as non-conformance reports. It is understood that only NCRs and OOS which have an adverse effect on the quality of Product will be taken into consideration in determining whether a Batch is a Conforming Batch or a Non-Conforming Batch. In the absence of any NCR or OOS which has an adverse effect on the quality of Product, Fujifilm Quality will complete Disposition, issue a certificate of analysis and a cGMP compliant statement.
(d) The following provisions shall apply if during Disposition, it is ascertained that a cGMP Batch produced during a Manufacturing Stage is a Non-Conforming Batch:
(i) The Non-Conforming Batch shall not be delivered lo Checkmate, unless Checkmate requests it. If Checkmate requests delivery of the Non-Conforming Batch, Fujifilm shall deliver such Non-Conforming Batch in accordance with Clause 4.1.
(ii) If Checkmate does not wish to take delivery of the Non-Conforming Batch, and Checkmate wishes to continue the applicable Programme, Fujifilm shall use Commercially Reasonable Efforts to either:
(1) rework or reprocess the Non-Conforming Xxxxx in accordance with cGMP, provided that Checkmate consents to such rework or reprocessing; or
(2) manufacture a further cGMP Batch.
(iii) The following provisions shall apply if the Non-Conforming B...
Quality Matters
