Common use of Quality Assurance Acceptance Clause in Contracts

Quality Assurance Acceptance. 6.1. Shire represents, covenants and warrants to B▇▇▇ that: (a) all AG Product hereunder shall be produced in accordance with cGMP and other Applicable Laws, rules and regulations and that none of the AG Product supplied hereunder shall be adulterated or misbranded as defined by the Act; and (b) all shipments of AG Product supplied hereunder shall meet the specifications and quality control standards set forth in the NDA or otherwise requested by B▇▇▇ and approved by Shire. (c) Shire or a Shire Affiliate will use Commercially Reasonable Efforts to maintain throughout the Term of this Agreement all permits, licenses, registrations and other forms of governmental authorization and approval required in order for Shire to perform its obligations hereunder in accordance with all Applicable Laws. (d) Shire or a Shire Affiliate owns and possesses all right, title and interest in the NDA. (e) Shire has the right to grant all of the rights and licenses granted herein to B▇▇▇ under the Adderall XR Intellectual Property, and it is not under any obligation to any Third Party that conflicts with the terms of this Agreement. 6.2. Shire shall perform all quality control tests and other inspections required by applicable cGMP standards and the NDA and shall furnish to B▇▇▇ a certificate of analysis together with each lot of AG Product shipped to B▇▇▇. Shire will also provide B▇▇▇ with Material Safety Data Sheets as required by Applicable Law for the AG Products, and updates of same as necessary.

Quality Assurance Acceptance. 6.1. Shire represents, covenants and warrants to B▇▇▇▇ that: (a) all AG Product hereunder shall be produced in accordance with cGMP and other Applicable Laws, rules and regulations and that none of the AG Product supplied hereunder shall be adulterated or misbranded as defined by the Act; and (b) all shipments of AG Product supplied hereunder shall meet the specifications and quality control standards set forth in the NDA or otherwise requested by B▇▇▇▇ and approved by Shire. (c) Shire or a Shire Affiliate will use Commercially Reasonable Efforts to maintain throughout the Term of this Agreement all permits, licenses, registrations and other forms of governmental authorization and approval required in order for Shire to perform its obligations hereunder in accordance with all Applicable Laws. (d) Shire or a Shire Affiliate owns and possesses all right, title and interest in the NDA. (e) Shire has the right to grant all of the rights and licenses granted herein to B▇▇▇▇ under the Adderall XR Intellectual Property, and it is not under any obligation to any Third Party that conflicts with the terms of this Agreement. 6.2. Shire shall perform all quality control tests and other inspections required by applicable cGMP standards and the NDA and shall furnish to B▇▇▇▇ a certificate of analysis together with each lot of AG Product shipped to B▇▇▇▇. Shire will also provide B▇▇▇▇ with Material Safety Data Sheets as required by Applicable Law for the AG Products, and updates of same as necessary. 6.3. Shire will promptly notify ▇▇▇▇ of any request from the FDA to change AG Product specifications or Labeling and will notify ▇▇▇▇ in writing as promptly as practical of any proposed or actual changes in specifications. 6.4. ▇▇▇▇ shall conduct, at its own expense, such tests as it deems necessary to determine the compliance of the AG Product with the requirements of Section 6. 1. ▇▇▇▇ shall notify Shire as soon as possible after its receipt of each shipment of the AG Product of any non-compliance of the AG Product with the requirements of Section 6.1 revealed by such testing.