Provision Language
Definitions
“Emergency Use Authorisation” means any emergency use approval issued pursuant to Regulation 174 of the Human Medicines Regulations 2012 (or any replacement or superseding legislation).
“UK Supply Chain” refers to the Drug Substance Manufacturers and Drug Product Manufacturers listed on a redacted schedule to the agreement.
2. Governance
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2.4 The Parties agree that Purchaser shall have a right of consultation in respect of the matters set out in Part A of schedule 5 [Project Managers’ Scope] or any other matters which will negatively impact or delay supply under this Supply Agreement. Before AstraZeneca takes or implements any decisions under, or which will negatively impact or delay supply under, this Supply Agreement, or are decisions in respect of those matters set out in Part A of schedule 5, AstraZenca shall ensure that its Project Manager first provides the Purchaser’s Project Manager with a reasonable opportunity to consult on and provide comments on AstraZeneca’s proposed decision. AstraZeneca shall take on board and use Best Reasonable Efforts to take into account and implement any reasonable requests and comments of the Purchaser in respect of such matters.
4. Manufacturing Facilities and Materials
4.1 AstraZeneca represents to the Purchaser that Schedule 2 is a complete list of all Facilities that are, subject to clause 3.2.3, designated for Manufacture of Product to be supplied to the Purchaser pursuant to this Supply Agreement. AstraZeneca shall not, and shall procure that its Affiliates and Subcontractors shall not use any other facilities, beyond those listed in Schedule 2, except as provided in clause 3.2.3.
4.2 AstraZeneca either owns or operates the Facilities within the scope of its [REDACTED] obligation or has or will have a legally binding agreement in place, in each case in order to use, or have used, the Facilities within the scope of its [REDACTED] obligations for the purposes of Manufacturing Product pursuant to this Supply Agreement and to ensure the supply and Delivery of Product. AstraZeneca represents to the Purchaser that, to AstraZeneca’s knowledge, the Facilities for the UK Supply Chain will be appropriate and sufficient for the Manufacture and Delivery of Conforming Product in the volumes that are the subject of the Order and in accordance with the terms of this Supply Agreement.
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4.4 AstraZeneca shall, with effect from the Effective Date and throughout the Term, use Best Reasonable Efforts to maintain, rotate and replenish an effective supply of Manufacturing materials (including raw materials) required for the Manufacture of the Product in order to ensure that AstraZeneca, its Affiliates and their Subcontractors have sufficient materials and raw materials to Manufacture of the product in order to meet the Delivery Schedule. AstraZeneca shall use Best Reasonable Efforts to mitigate any waste or unused amount of Manufacturing materials purchased and included within Cost of Goods.
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6. Delivery
6.1 The preliminary delivery schedule, setting forth the quantities and timing of Delivery of each instalment of the Product, initially as estimated by AstraZeneca as of the Effective Date, is set out in schedule 3 (as updated from time to time in accordance herewith, the “Proposed Delivery Schedule“). AstraZeneca undertakes that it shall promptly update and refine such
Proposed Delivery Schedule, from time to time, and notify the Purchaser of the same, to provide Purchaser its most accurate estimate, to AstraZeneca’s knowledge, of anticipated quantities and timing but in doing so shall use its Best Reasonable Efforts to keep as close to the original version of the Proposed Delivery Schedule set out at the Effective Date. Using its Best Reasonable Efforts to deliver the same as soon as reasonably possible, and in any event not later than thirty (30) calendar days prior to each anticipated Delivery, AstraZeneca shall provide a firm and final delivery schedule for each instalment (“Delivery Schedule“) setting forth the quantities of Product for delivery in that instalment and the date for delivery of that instalment of Product within the Order. Once the Delivery Schedule is notified to the Purchaser for an instalment of the Product, AstraZeneca may not adjust that Delivery Schedule without the prior consent in writing of the Purchaser. For the avoidance of doubt, AstraZeneca’s delivery obligations herein remain subject always to AstraZeneca’s obligations to supply Product in accordance with [REDACTED].
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6.3 AstraZeneca shall not be in breach of its obligation to comply with the delivery schedule if:
6.3.1 there is a material delay in AstraZeneca securing the Marketing Authorisation for the Product in the Territory (an Emergency Use Authorisation for the Product in the Territory) provided that (i) AstraZeneca, its Affiliates and Subcontractors used all Best Reasonable Efforts in their respective activities to file for and secure the grant or issuance of the same; and (ii) delay was not caused by the breach of this Supply Agreement, the Licence Agreement or the Gross Negligence of, AstraZeneca, its Affiliates or Subcontractors;
6.3.2 there is any minor variance of dates of Delivery compared to the Delivery Schedule of up to five (5) Business Days due to the unpredictable nature of the Manufacturing of the Products, so long as such variance is notified to Purchaser as soon as reasonably practicable (a “Grace Period“); or
6.3.3 the Parties agree by mutual consent to vary the Delivery Schedule, provided however that AstraZeneca has and shall continue to use all Best Reasonable Efforts to procure supply and Delivery of Conforming Product in accordance with (i) [REDACTED] and (ii) the Delivery Schedule and failing that as soon as possible outside of the timelines set forth in the Delivery Schedule.
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6.7 If AstraZeneca, its Affiliates or any Subcontractor experience capacity limitations or shortages of the Product or a shortfall in bulk drug substance and/or other raw materials, ingredients, components, consumables and other materials (including Labelling and packaging materials) which are to be used for the Manufacture of the Product, then:
6.7.1 AstraZeneca shall promptly notify the Purchaser in writing if AstraZeneca, its Affiliates or any Subcontractor is unable, or anticipates with reasonable certainty that it will be unable, to supply Product in accordance with the requirements of this Supply Agreement in the quantities and within the time periods specified in the Order and Delivery Schedule;
6.7.2 the Parties shall discuss in good faith the reasons for such limitations or shortages (as applicable) and how to resolve such issues; and
6.7.3 AstraZeneca shall use its Best Reasonable Efforts to ensure that the Purchaser continues to receive [REDACTED] of the Product as necessary to meet the Order in accordance with the terms and conditions of this Agreement.