Master Alliance Provisions Guide (MAPGuide)

UK Secretary of State – Roche, REGN-COV2 Supply Agreement

  • Liability | Representations & Warranties

5. Limited Warranty; Indemnity; Limitation of Liability

(a) Roche warrants, represents and undertakes to UK that: 

(i) at the time of Delivery, Product shall have been manufactured, labelled, handled, stored, transported, sold and packaged in accordance with (A) the relevant Marketing Approval; (B) all applicable Laws including Good Manufacturing Practice (GMP) (including record and sample keeping, deviation reporting, testing and quality requirements), Good Distribution Practices (GDP), Good Pharmacovigilance Practices (GVP); (C) all other Regulatory Licenses applicable to the Product; and (D) the specifications set forth in the approved Product monograph and Annex A; 

(ii) all Product supplied and Delivered pursuant to this Agreement shall be new, unadulterated and have not (A) previously left the control of Roche or an affiliate or licensor of Roche at any time prior to Delivery; (B) been rejected or returned by any other entity; or (C) been reprocessed or reworked; 

(iii) all Product Delivered shall have [REDACTED] of remaining shelf life left by reference to the expiry date (the “Minimum Shelf Life&#8220😉 calculated from the actual date of Delivery; 

(iv) all Documentation supplied with Product pursuant to this Agreement shall be complete and accurate in all respects and the Product to which such Documentation relates shall comply with such Documentation; 

(v) it shall, in fulfilling its obligations hereunder and supplying Product to UK, comply with (and ensure the Products comply with) all applicable Law in the Territory; 

(vi) following grant of a Marketing Approval, all Product prior to Delivery shall be finally quality released for supply by an entity established in the Territory; 

(vii) it and any parties or persons involved in the manufacture, packaging, labelling, storage, transport and supply of Product have manufacturing and warehousing capacity and facilities other than UK Storage Facilities for which UK shall be responsible that are sufficient for the manufacture and holding of Product compliant with the requirements under this Agreement and licensed by the MHRA for such activities; 

(viii) it has and shall maintain a properly documented system of quality controls and processes (including quality management systems) that, at a minimum, meet requirements under applicable Laws and which cover all aspects of its obligations under this Agreement (including those it may subcontract to others) and shall at all times comply with such quality controls, systems and processes; 

(ix) as at the Effective Date it has the right and authority to enter into this Agreement and it has the capability and capacity to fulfil its obligations under this Agreement; 

(x) as at the time of their Delivery, title to the Product Delivered under this Agreement will pass to UK as provided in this Agreement free and clear of any security interest, lien, charge or other encumbrance; 

(xi) 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 Roche; 

(xii) as at the Effective Date there are no material agreements existing to which Roche is a party which prevent Roche from entering into or performing this Agreement; 

(xiii) as at the Effective Date all necessary actions to authorise the execution of and performance of its obligations under this Agreement have been taken by Roche before such execution; 

(xiv) 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 UK immediately if it becomes aware of any actual or suspected incidents of slavery or human trafficking in its supply chains; 

(xv) it shall at all times conduct its business in a manner that is consistent with any anti–slavery policy of UK; 

(xvi) throughout the Term, it shall maintain, review, update and implement a business continuity plan that is reasonably adequate and effective to provide for the continuity of supply to UK of the Product during events or issues that could adversely impact on the operations of Roche, its affiliates and contractors and other parties involved in the manufacture, packaging, labelling, storage, transport and supply of Product, and the ability of Roche to make available and Deliver Product, and it shall update its business continuity plan from time to time as reasonably appropriate and necessary; 

(xvii) it shall not enter into any agreement with any third party that would by its terms conflict with or would be reasonably expected to prevent Roche from meeting its obligations with respect to Delivery in accordance with this Agreement; 

Except for the warranties set forth in this Agreement, to the maximum extent permitted by applicable Law Roche expressly excludes all other remedies or warranties, expressed or implied, statutory or otherwise, in relation to the Product, including, without limitation, any warranty or condition of merchantability or of fitness for a particular purpose. 

[The remainder of this clause has been redacted.]