Quality Systems. Zeltiq shall establish and maintain an ISO 13485 compliant quality system for the design and manufacture of the Products and shall comply with the obligations listed in Exhibit B of this Agreement.
Quality Systems. By accepting the PO Supplier agrees to comply with any and all industry quality standards (including without limitation TS16949, QS 9000 and ISO 9000, as amended or superseded) and upon receipt of reasonable prior notice, to provide full access to Tiercon in order to conduct audits of Supplier’s Order Processing system in keeping with such standards.
Quality Systems. Licensee shall maintain throughout the Term an effective system for evaluating, monitoring and ensuring the continuing quality of products and services Licensee sells and offers in connection with the Licensed Marks. With respect to any particular facility where such products are manufactured or processed, or where such services are provided, continued certification of ISO 9001 or its equivalent will be considered sufficient to satisfy this obligation.
Quality Systems. Centogene shall be obliged to maintain and diligently document a quality assurance system and a risk management system for the manufacture and supply of Contract DBS Test Kits in accordance with Applicable Laws, Standards and Regulatory Approvals as evidenced by certificates from Regulatory Authorities, such certificates to be based on Applicable Laws and Standards governing the manufacture and distribution of the product, as classified on the Effective Date. In the EU. the Contract DBS Kit is, as of the Effective Date, classified as a Class I IVD device. Centogene’s quality systems shall include written policies and procedures that address, at a minimum, the following: Quality System including: design control, training, supplier & purchasing controls, supplier audits, vendor change notifications, facilities and equipment, exception / deviation notification, Complaint reporting and CAPA; facilities and equipment systems; laboratory control systems; data protection, protection of IT networks.
Quality Systems. Centogene shall maintain systems of operation and quality assurance that are consistent with Applicable Laws and GLP and as otherwise may be required by Applicable Laws. Such systems shall include written policies and procedures that address, at a minimum, the following: quality systems including: training, supplier & purchasing controls, supplier audits, vendor change notifications, facilities and equipment, exception / deviation notification, complaint reporting and CAPA; facilities and equipment systems; laboratory control systems; data protection, protection of IT networks.
Quality Systems. Mechanisms exist to help personnel clearly understand their roles and responsibilities (e.g., work instructions, guidance documents, work plans, protocols, requirements, SOPs).
Quality Systems. Mechanisms exist to help personnel clearly understand their roles and responsibilities (e.g., work instructions, guidance documents, work plans, protocols, requirements, SOPs). • Quality Control processes exist to show specifications are met. […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] […***…] Xxx Xxxxx and Company (hereinafter referred to as the “Subscriber”) hereby agrees to purchase, and Zymeworks, Inc. (the “Corporation”) hereby agrees to issue and sell to the Subscriber, [•] Common Shares of the Corporation (the “Shares”) for the aggregate subscription price of CDN$[•] (the “Subscription Price”), representing a subscription price of CDN$[•] per Share, upon and subject to the terms and conditions set forth herein (the “Agreement”). This Agreement is entered into in connection with that certain Licensing and Collaboration Agreement, by and between the Subscriber and the Corporation, dated as of October 22,2014 (the “License and Collaboration Agreement”).
Quality Systems. The Provider is required to: a Have developed written and applied protocols and policies which outline the standards for the Services. b Have in place, and follow, written protocols, procedures and policies for the management of the Services. This document needs to be kept up to date and made readily available for staff to read. The document will include written procedures on the following: i receiving and responding to complaints ii systems to measure service user satisfaction with the Service iii collection, privacy and storage of information iv roles and responsibilities of those providing the Services v systems for recording and reporting sentinel and serious events vi culturally appropriate practices vii rights and responsibilities of Service Users viii compliance with relevant legislation, regulations, ethical standards and clinical protocols. c Ensure that records and documentation are maintained in a manner that is current, detailed and organised and enables effective provision of Services. d Comply with all reasonable instructions and directions of the Purchasers.
Quality Systems. The Seller shall implement a Quality Management System that is subject to Buyer review and audit.
Quality Systems. 2.1 Product manufactured under this plan fall under the Seller’s quality.
2.1.1. Seller shall be ISO 13485 (current) certified and shall maintain this status.
2.1.2. Seller shall be FDA registered and shall maintain this status.
2.1.3. Information on the Seller’s quality system status, including copies of certificates, shall be provided to Buyer upon request. Any changes to that status shall be communicated to Buyer.
2.2 Buyer shall be allowed to perform a quality system audit at least once a year and more frequently if deemed necessary and mutually agreed.
2.2.1. Such audits shall be scheduled in advance.
2.2.2. Seller shall address any Product deficiencies mutually agreed upon during such audits.
2.3 Where appropriate, Seller shall grant access for inspection/audit of its non-proprietary facility areas, its quality system, and its non-proprietary production/inspection/test processes used for the production of Product to Buyer’s Notified Body and/or to EU Competent Authorities as necessary.
