Non-Reliance and Entire Understanding Clauses
Non-Reliance and Entire Understanding Clauses
Finally there is the Non-Reliance clause and the Entire Understanding clause, which can be dealt with relatively briefly.
Clause 28.5 of the Contract’s Schedule 2 (General Terms and Conditions) agreed that neither party has relied on any statement that is not “set out in this Contract or ... made fraudulently”. Under Clause 28.5 the parties further agreed not to claim damages for any such (non-contractual, non-fraudulent) “misrepresentation or undertaking (whether made carelessly or not.)”. This is, the kind of clause which not infrequently underpins a case in contractual estoppel ( ie deployed against claims of reliance on extra contractual misrepresentations). Medpro’s attempts to suggest that this clause was not apt to cover more than claims for damages for misrepresentation or breach of warranty appears to ignore the opening words of the clause which are not so limited (“Each party acknowledges and agrees that it has not relied on any representation, warranty or undertaking (whether written or oral) in relation to the subject matter of this Contract…”).
The Entire Understanding clause, clause 28.9 appears, like the clause in ABN Amro Bank NV v Royal & Sun Alliance Insurance[2021] EWCA Civ 1789, [2022] 1 WLR 1773 to exclude estoppels.
Accordingly had the estoppel case been capable of getting off the ground on its merits, it would then have faced insuperable difficulties in the contractual terms, this being a case where fraud is not suggested as a way round the relevant clauses.
- Heading
- This judgment was handed down by the court in person and by circulation to the parties’ representatives by email and released to The National Archives. The date and time for hand-down is deemed to be
- Sterility 101: An Introduction to sterility and Medical Device Law
- ISO 11137: Requirements of a Sterilisation Process
- Sterility level: EN 556
- Medical devices: MD Directive and MDR 2002
- Other relevant standards
- Summary
- Factual Background
- The PPE Cell
- The Recommendation
- The Essential Technical Requirements Document (“ETRD”)
- Precontractual Negotiations
- Closing
- Final Approval and Contract
- Manufacturing, delivery and inspection
- Rejection of the Gowns
- Testing of Gowns
- The Trial and issues
- The Contractual Claim
- The parties’ cases on construction
- The significance of the accepted obligation to deliver gowns with an SAL of 10 -6
- Was there breach of a requirement for a formally validated process in this case?
- Did the Contract require EN 556 or an Equivalent Technical Solution?
- Did the Contract require CE marking?
- The original case: Statistics, Physical Testing and Sterility
- Estoppel and related concepts
- Representation/assumption: clear?
- Approval of an ETS in place of EN 556
- Meeting the technical requirements/ No requirement to have a CE mark with an NB number
- Reliance
- Estoppel and validated process/SAL
- Non-Reliance and Entire Understanding Clauses
- Remedies
- Was the right to reject lost?
- Damages: The value of the Gowns and Mitigation
- Damages: The Claim for Storage Costs and Gown Disposal
- The Counterclaim
- Common mistake and rectification
- Negligent misstatement
- Conclusion
- Annex 1: Statistics, Physical testing and Sterility
- The testing
- Statistics
- The evidence and its implications
- The evidence gap
- Conclusion
- Annex 2: Relevant provisions of the Contract The Contract between DHSC and Medpro consists of a front page and several documents
- Order Form Section 5 of the Order Form “ The Supplier shall supply the deliverable described below on the terms set out in this Order Form and the Schedules and Annex A. Unless the Contract otherwise requires, c
- Section 7 of the Order Form is headed “Specification” and states: “The specification of the Deliverables is as set out in Annex A.1 – A.9 [26.06.2020]. Not as embedded/attached documents. Please confi
- Schedule 1
- Clause 2.2 of Schedule 1 states that the Order Form is to “ include, without limitation, the Authority’s requirements in the form of its specification and other statements and requirements, the Suppli
- Clause 3 of Schedule 1 is headed “ Quality assurance standards ” and states: “The following quality assurance standards shall apply, as appropriate, to the manufacture, supply, and/or installation of
- Conclusions
![CL-2022-000676 - [2025] EWHC 2486 (Comm)](https://backend.juristeca.com/files/emisores/logo_WAai98v.png)