Quality Agreement
Quality Agreement. Means a separate written agreement that has been entered into between BryoLogyx and BryoLogyx's contract manufacturer for the API that describes the quality assurance and technical requirements for Processing, a copy of which will be provided to Neurotrope as promptly as possible when the Quality Agreement has been updated for the cGMP synthetic processing of bryostatin-1, which Quality Agreement, when so furnished, will be deemed confidential and will thus be subject to the confidentiality...
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Found in
Neurotrope, Inc. contract
Quality Agreement. Means the quality agreement to be entered into by the Parties, setting out the responsibilities of the Parties in relation to quality as required for compliance with cGMP.
Found in
Vaxcyte, Inc. contract
Quality Agreement. 1.12. "Quality Agreement" shall mean that certain Quality Assurance Agreement, dated of even date herewith, by and between INTERSECT and HOVIONE, which sets forth (a) the roles and responsibilities of the Parties with respect to the quality assurance for the API and (b) how the Parties' quality operations shall interact with each other in connection with the same.
Found in
Intersect ENT, Inc. contract
Quality Agreement. Means that applicable version of the quality agreement between the parties in relation to the Product and its Manufacturing, including, without limitation by way of a master agreement between SUPPLIER and/or its Affiliate(s) and a NOVARTIS Affiliate, a copy of which is attached hereto as ANNEX 7.
Found in
Recro Pharma, Inc. contract
Quality Agreement. The quality agreement (including all schedules and appendices attached thereto), as further defined in Section 7.6, setting forth the guidelines and responsibilities of the parties in connection with the Product as they relate to quality control, quality assurance, testing, qualification, validation, and release, and authorization for shipment, as such quality agreement may be amended from time to time by the parties in accordance with the terms thereof.
Quality Agreement. Means the Quality Agreement applicable to the Services being performed by Catalent.
Found in
CATALYST BIOSCIENCES, INC. contract
Quality Agreement. Means the Quality Agreement executed by the parties, and attached hereto as Exhibit A, and as amended and updated by mutual approval from time to time.
Found in
Akebia Therapeutics, Inc. contract
Quality Agreement. Means a formal agreement between CyDex and Company that sets forth the quality expectations, responsibilities, rights (including, as applicable and agreed upon, audit requirements) and quality measures and good manufacturing practices relating to the manufacture and supply of Captisol to assure drug quality, safety and efficacy consistent with FDA guidance or equivalent foreign regulatory authority requirements for Quality Agreements. Any such agreement may be amended from time to time by...
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Found in
MARINUS PHARMACEUTICALS INC contract