Provision Language
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);
13.1.2 subject to clause 3.5.4, the Products shall at the time of Delivery (or, in the event that Purchaser notifies AstraZeneca that Purchaser cannot receive the Product within ten (10) Business Days of AstraZeneca’s written notice pursuant to clause 6.5, then as of the date of Delivery originally notified by AstraZeneca to Purchaser pursuant to clause 6.5) meet the Minimum Shelf Life requirement;
13.1.3 AstraZeneca shall, in fulfilling its obligations hereunder and supplying Product to the Purchaser shall comply with (and ensure the Products comply with) the regulatory requirements required by Applicable Laws in the Territory, including relevant provisions of:
(a) Directive 2001/83;
(b) Title II of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency;
(c) all Applicable Laws, regulations and Guidelines within the UK implementing the legislation referred to in clause 13.1.3(a) and 13.1.3(b) above;
(d) any Guidelines or directions or like documents that may be published during the Term of this Supply Agreement by the MHRA or EMA and are applicable to the Product at the time of manufacture; and
(e) the Medicines Acts 1968 and 1971 and the Human Medicines Regulations 2012 and the regulations made thereunder in the respect of the sale, supply, importation, manufacture or assembly of the Product. For the avoidance of doubt the Human Medicines Regulations 2012 take precedence in all matters covered therein;
13.1.4 it and its Affiliates have, and it will use Best Reasonable Efforts to ensure that its Subcontractors have, manufacturing and warehousing capacity and facilities that are, to AstraZeneca’s knowledge, sufficient to Manufacture Products compliant with the requirements under this Supply Agreement;
13.1.5 to the extent required by clause 4.4, it will ensure that it procures and maintains sufficient levels of raw materials, consumables and other materials required to Manufacture the Order volumes in accordance with its obligations under this Supply Agreement; and
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.
13.2 AstraZeneca further warrants and undertakes to the Purchaser that: […]
13.2.1 as at the Effective Date it has the right and authority to enter into this Supply Agreement and that it has the capability and capacity to fulfil its obligations under this Supply Agreement;
13.2.2 as at the Effective Date it is a properly constituted limited liability company and that it is fully empowered by the terms of its constitutional documents to enter into and to carry out its obligations under this Supply Agreement and the documents referred to therein;
13.2.3 as at the Effective Date there are no pending or threatened actions or proceedings before any court or administrative agency which would materially adversely affect the financial condition, business or operations of AstraZeneca;
13.2.3 as at the Effective Date there are no material agreements existing to which AstraZeneca is a party which prevent AstraZeneca from entering into this Supply Agreement;
13.2.4 as at the Effective Date all necessary actions to authorise the execution of and performance of its obligations under this Supply Agreement have been taken before such execution;
13.2.5 it shall: (i) comply with all Applicable Law and Guidance to ensure that there is no slavery or human trafficking in its supply chains; and ii) notify the Purchaser immediately if it becomes aware of any actual or suspected incidents of slavery or
human trafficking in its supply chains;
13.2.6 it shall at all times conduct its business in a manner that is consistent with any anti- slavery Policy of the Purchaser and shall provide to the Purchaser any reports or other information that the Purchaser may request as evidence of AstraZeneca’s compliance with this clause 13.2.7 and/or as may be requested or otherwise required by the Purchaser in accordance with its anti-slavery Policy;
13.2.7 throughout the Term, to the knowledge of AstraZeneca, its Business Continuity Plan [REDACTED] during a Business Continuity Event, and it shall update its Business Continuity Plan from time to time as reasonably appropriate and necessary;
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13.2.9 it shall not enter into any agreement with any foreign Government, funder or Third Party that would by its terms conflict with AstraZeneca’s obligations hereunder or would be reasonably expected to prevent AstraZeneca from performing its obligations hereunder.
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13.2.11 at the time of their Delivery, title to the Product supplied under this Supply Agreement will pass to the Purchaser as provided in this Supply Agreement free and clear of any security interest, lien, charge or other encumbrance.
16. Intellectual Property
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16.2 AstraZeneca warrants, represents and undertakes to the Purchaser that either it is the sole proprietor and legal and beneficial owner of all Intellectual Property Rights in the Product or it is licensed by the relevant owners to Manufacture and supply the Product in accordance with this Supply Agreement and shall use Best Reasonable Efforts to ensure that it remains the owner and/or licensee (as applicable) of the Intellectual Property Rights in the Product throughout the Term of this Supply Agreement.
16.3 AstraZeneca warrants and represents to Purchaser that, to AstraZeneca’s knowledge, any receipt, keeping, sale and use of the Product by the Purchaser, Authorised Agent, any Administering Entity or any Devolved Administration in accordance with this Supply Agreement shall not infringe any Intellectual Property Rights of any Third Party.