Agreed Standards definition

Agreed Standards means all standards, specifications, guidelines and regulations as to quality, safety and performance as are consistently applied by Miltenyi from time to time with respect to the manufacture and quality control of the relevant Miltenyi Product in accordance with Miltenyi’s established quality system, standard operating procedures, and quality control procedures, and includes (i) any standard(s) as may be specifically determined to be applicable to the manufacture and quality control of the relevant Miltenyi Product (if any) (for example, with regard to the manufacturing of cell processing reagents or processing aids) by agreement between Miltenyi and any relevant Regulatory Authority/ies and as set forth in Miltenyi’s relevant Master Files and/or the Quality Agreement and (ii) any standard(s) as may be expressly agreed between the Parties with respect to a relevant Miltenyi Product from time to time in writing in this Agreement or in an amendment to this Agreement.

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Agreed Standards means the standards of conduct set out in Schedule 5 (Agreed Standards);

Agreed Standards means the standards which the Standards Group

Examples of Agreed Standards in a sentence

• Agreed Standards are those standards that have been discussed and accepted by all Parties as required for the Programme.

• Miltenyi shall promptly address and correct any deficiencies from Agreed Standards identified in connection with such inspections.

• All Miltenyi Products supplied pursuant to Section 2.1 shall be manufactured and quality controlled under an appropriate quality system in accordance with Agreed Standards, as more fully described in the Quality Agreement.

• Miltenyi shall have standard analytical testing performed on each batch of Miltenyi Product to be shipped to Autolus, in accordance with Agreed Standards and the procedures described in the corresponding documentation, to verify that Miltenyi Product meets Product Specifications and that it was manufactured in accordance with Agreed Standards and Applicable Laws.

• For clarity, [***] shall not be liable for any costs and expenses incurred by [***] in order to comply with Applicable Laws, Regulatory Laws, Agreed Standards, the Quality Agreement or Product Specifications.

• Notwithstanding anything herein, Autolus or Autolus’ Licensees duly authorized representatives may conduct additional “for cause” audits to investigate a failure or potential failure of Miltenyi to adhere to the Applicable Laws, Regulatory Laws, Agreed Standards, the Quality Agreement or Product Specifications.

• In recognition of the shared threat, standards that the Sponsor Body proposes to adopt in relation to cyber security are to be Agreed Standards.

• All Miltenyi Products shall be manufactured and quality controlled in compliance with and pursuant to: (i) the Agreed Standards, (ii) the requirements of an applicable Quality Agreement (as defined below), and (iii) Applicable Laws.

• CMO agrees to perform the Services set forth in each SOW in a workmanlike manner and with professional diligence and skill in accordance with the applicable Agreed Standards, the terms and conditions of this Agreement, and such SOW.

• If during the Term Autolus desires Miltenyi to make any Change not necessary to comply with changes in Agreed Standards made by Regulatory Authorities, Applicable Laws and/or other requirements of Regulatory Authorities (in each case, a “Autolus-Requested Change”), Autolus shall notify Miltenyi thereof in writing.

More Definitions of Agreed Standards

Agreed Standards means, to the exclusion of any other standards: (a) with respect to particular Services under a SOW, the agreed standards for performance of such Services, as expressly set forth in such SOW; or (b) with respect to any Biologic to be manufactured and supplied under a SOW, the agreed standards for manufacture and supply of such Biologic, as expressly specified in such SOW or in the applicable Quality Agreement (if any). Notwithstanding the foregoing, Agreed Standards shall include any standards imposed by Applicable Laws and compliance with CMO’s standard and customary operating procedures relating to such activities.

Agreed Standards means one or more of the following, as mutually agreed by the Parties: (a) ISO/IEC 27001:2013 (Information security management systems: Requirements); (b) ISO/IEC 27017; (c) Service Organization Control 2 (“SOC 2”); (d) Control Objectives for Information and Related Technologies (COBIT) by ISACA; (e) any other applicable ISO standards relevant to the Services; (f) adherence to a recognised industry cybersecurity framework e.g. NIST CSF (g) any standards that the Parties agree in writing from time to time that the Supplier shall comply with; and (h) where personal health or health information is to be processed as part of the Services, The Security Standards for the Protection of Electronic Protected Health Information (the Security Rule);

Agreed Standards means the standards which the Standards Group agrees should apply to the Programme;

Agreed Standards means the Design Standards required by the Town for the design, construction and installation of the Local Improvements in the Development Area, including any alterations to or amendments of such standards and specifications which may be agreed upon in writing by the Town and the Developer. The “Agreed” Standards shall be the Design Standards of the Town in place at the time of the Plans being provided to the Director of Public Works and Land Services. For a phased development, the “Agreed Standards” shall be the Design Standards of the Town in place at the time of Plans being provided to the Director of Public Works and Land Services for each phase of phased development.