Provision Language
Definitions
“UK Supply Chain” refers to the Drug Substance Manufacturers and Drug Product Manufacturers listed on a redacted schedule to the agreement.
4. Manufacturing Facilities and Materials
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4.5 AstraZeneca shall use either the MHRA procedure or the EMA centralised procedure or both in order to obtain the Marketing Authorisation in the Territory at the earliest possible date. If AstraZeneca uses only the EMA centralised procedure and if the Marketing Authorisation is not granted before 1 January 2021 and the EMA centralised procedure ceases to be a recognised procedure for granting a Marketing Authorisation under English law, then AstraZeneca shall follow the advice of the MHRA and take steps to secure a Marketing Authorisation as quickly as possible for the Territory based on that advice which may include pursuing a separate application for a Marketing Authorisation with the MHRA in parallel with the EMA centralised procedure. AstraZeneca shall ensure that the Marketing Authorisation granted for the Territory will include the UK Supply Chain and the other Manufacturing facilities in Europe as Facilities qualified and validated for Manufacture of the Product to be supplied to Purchaser under this Supply Agreement.
13. Warranty and Undertakings
13.1 AstraZeneca warrants and undertakes to the Purchaser that, at the time of Delivery:
13.1.1 the Products shall have been Manufactured, packaged, labelled, handled, stored and transported in accordance with, and comply in all respects with, (i) the Specifications; (ii) the Documentation and any Certificate of Analysis, (iii) the Marketing Authorisation (unless Delivered pursuant to an Emergency Use Authorisation); and (iv) Applicable Laws including Good Manufacturing Practices (including record and sample keeping, deviation reporting, testing and quality requirements);
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13.1.6 it has and shall maintain a properly documented system of quality controls and processes covering all aspects of its obligations under this Supply Agreement (including those it may subcontract to others) and shall at all times comply with such quality controls and processes.