Quality Agreements definition

Quality Agreements means the agreements described in Section 5.7.

Quality Agreements shall have the meaning set forth in Section 2.5.1 of the Supply Agreement.

Quality Agreements means the Clinical Quality Agreement(s) and the Commercial Quality Agreement(s).

Examples of Quality Agreements in a sentence

• If there are any issues with a shipment of Vaccine Components or Licensed Know-How or if SIIPL [***] believes that the Vaccine Components do not comply with the Vaccine Component Specification, cGMP, or other applicable requirements under the Quality Agreements then SIIPL must notify Novavax [***] after its receipt of a shipment.

• This Agreement together with the Pharmacovigilance Agreements and the Quality Agreements sets forth all intentions, understandings, covenants, promises, warranties, representations, conditions, rights, and obligations of the Parties and supersedes all previous and contemporaneous agreements, understandings, negotiations and proposals relating to the subject matter hereof.

• In the event of a separate assessment, NVAO must receive the plans for the Quality Agreements by no later than 8 weeks before the date of the panel visit.

• GHTF/SG3/N17R9:2008 • Guidance for Industry: Quality Agreements Contract Manufacturing Arrangements for Drugs, FDA, Nov 2016; Pharmaceutical Quality/Manufacturing Standards (CGMP) • VERORDNUNG (EU) 2017/745 DES EUROPÄISCHEN PARLAMENTS UND DES RATES vom 5.

• SIIPL may also test shipments of Vaccine Components using the applicable methods of analysis specified in the Quality Agreements.

More Definitions of Quality Agreements

Quality Agreements shall have the meaning set forth in Section7.3.

Quality Agreements means the Quality Assurance Agreements for Drug Product and Drug Substance between the Parties.

Quality Agreements shall have the meaning set forth in Section 9.7.

Quality Agreements means the quality agreements entered into between Alcon and Novartis on or around the date of this Agreement, as referred to in the Manufacturing and Supply Agreements

Quality Agreements mean the Development Quality Assurance Agreement(s), the Commercial Quality Assurance Agreement(s), and the In-Vivo [***] Quality Assurance Agreement.

Quality Agreements means the Clinical Quality Agreement and Commercial Quality Agreement collectively, both of which are addenda to this Agreement under which the Parties allocate the pharmaceutical responsibilities, as further set forth in Section 8.2.

Quality Agreements means the one or more Quality Agreements, dated as of the Closing Date, between RTI OEM and RTI Surgical, related to the Distribution Agreement (Hardware) and Distribution Agreement (Tissue), in the forms mutually agreed upon by Parent and Buyer.