Final Approval and Contract
Final Approval and Contract
On 22 June, Mr Townsend sought approval for the Medpro Gowns deal (25m gowns until August) from Emily Lawson, Chief Commercial Officer, and Jonathan Marron, Director General for the Office for Health Improvement and Disparities. Mr Townsend followed up again in the evening, since “both vendors are very keen to understand when a decision is likely”. In a separate chain, Jen Shaw, Private Secretary to Jonathan Marron, queried about the need for sterile as opposed to non-sterile gowns. Mr Townsend replied that the recommendation was not for more non-sterile gowns. This was followed by an email from Emily Lawson: “There is an ongoing need for sterile gowns and the price is now excellent. I would recommend to the AO [Accounting Officer] he approve these deals”. Further up the line, the next day it was noted: “it rests with Emily and Jonathan to make a recommendation to David Williams. If there is further information that Emily and Jonathan need to make their assessment, can you please let us know?”
On 23 June, Mr Page chased Mr Graham again: “Please can we have an urgent update on the gown order. We have now lost a further 24 hours and that is on the back of lost time last week. We were told the priority was delivering as much stock in June yet every day we lost further production time and capacity as nobody seems capable of making a simple decision. It is now 24 hours since we submitted our best and final offer and you confirmed the other competing firm submitted their final offer on Sunday evening. How has a decision not been reached and approved?”
Mr Graham responded, stating: “We are all continuing to chase on this, and there are Directors personally involved in trying to elicit a decision. We have been assured that as soon as the answer is known it will be flowed down, and for my part I will certainly be in touch straight away after I receive the decision”.
Mr Page responded the following way: “In my 20 years of working I've never known a situation like this. How can it possibly still be that a decision has not been reached? One company is told they have been successful and one is told they are unsuccessful. It is verging on the farcical that one of the key requirements was how much stock could be provided by 30th June yet the powers that be are happy to waste further time making a simple decision. If the private sector operated in the same way as Government the entire economy would come to a grinding halt! Please can you ask those making the decision to have the courtesy and professionalism to pass their decision on.”
Mr Graham replied: “I can completely understand your frustration, and this isn't something I've experienced in my time on COVID so far. All I can say is that we are pushing as hard as possible, and we'll keep you updated as soon as anything changes.”
At the same time Mr Graham chased up on outstanding matters.
“If we do get approval, we will need to update the contract to reflect the revised pricing, the second factory (which has now been cleared, subject to the caveats below), and the need to reflect the delays to the production schedule. With that in mind, I’ve attached an updated draft contract, … The only other thing to notice in the order form is that we’ve got an additional clause 12.8 which relates to the declaration of conformity – ...
In terms of the second factory/product clearance, the only queries raised were that a) the approvers couldn’t see evidence of the packaging (I assume the boxes, rather than folding/bagging etc.) to confirm that it met the CE requirements – if you have photos of boxes from this factory I think that’s all they need for this, and b) in the declaration of conformity (DoC) Minor there is a minor error identified in that it Refers to Council Directive 92/42/EEC, whereas it should read 93/42/EEC.”
On 25 June, Mr Page submitted a revised schedule in response to Mr Graham’s request, and also attached photographic evidence of the final Medpro box for collection and delivery. The description of the gowns from Kunshan contained a valid CE label with notified body number which was provided by a notified body in Germany. This submission was approved by Mr Larter of Technical: “Technical assurance confirms that based on this and previous evidence provided the submission is acceptable to proceed to closing”. Thus, the second factory, Kunshan Jiehong, did submit proof of valid CE marking. It was approved by Technical on 25 June 2020 for the proposed supply of the gowns.
Meanwhile COVID-19 Finance Operations submitted the Medpro submission (as well as a second offer) to the Accounting Officer for approval on 24 June. A member of the Finance Operations team then requested sight of the original submission for Medpro “in anticipation of [the Accounting Officer] approving”, as this would be needed to set up the Purchase Order. This was sent through by Mr Graham.
Then on 25 June 2020 Mr Page sent through the signed Order Form which now included Kunshan. The price was now at £4.88 a gown, giving a total of £122 million.
On 26 June 2020, with Mr Williams’ authority which must somehow have been communicated to him, Mr Ed James signed the Contract for DHSC. In the morning of 27 June 2020, Mr Graham forwarded to Mr Page the Contract signed by DHSC. The Purchase Order followed on 29 June 2020.
The relevant terms of the contractual documents are given in Appendix 2. For present purposes the central point to note concerns the slightly complex way in which the Contract was constructed. It comprised:
An order form (signed on behalf of both parties); the Order Form is stated (Schedule 1, clause 2.2) to “include, without limitation, the Authority’s requirements in the form of its specification and other statements and requirements, the Suppliers responses, proposals and/or method statements to meet those requirements, and any clarifications of the Supplier’s responses, proposals and/or method statements as included [i]n these terms and conditions”;
Schedule 1 (“Key Provisions”), which contained two mandatory provisions (clauses 1 and 2) and various provisions which were to apply only where they “have been checked” (i.e. check-marked). Clauses 3, 4, 5, 8, 9 and 12 were checked;
Schedules 2, 3, and 4 which consist of various general conditions, definitions, and “additional special conditions”;
A set of annexures marked “A1” to “A9” which were said to be a “technical specification”. These were the various documents relating to the factories’ certification and packaging;
The Annexes to the Contract were split as between the two factories in which the Gowns were to be manufactured: Annexes 1-4 relate to WTT, and Annexes 5-9 relate to Kunshan Jiehong:
Annex A.1 – Packaging specifications – Wujiang Tutaike
Annex A.2 – Test Certification – Wujiang Tutaike
Annex A.3 – Certificate of Conformity – Wujiang Tutaike
Annex A.4 – QMS Certification – Wujiang Tutaike
Annex A.5 – Packaging specifications (individual) – Kunshan Jiehong
Annex A.6 – Packaging specifications (carton) – Kunshan Jiehong
Annex A.7 - Test Certification – Kunshan Jiehong
Annex A.8 – Declaration of Conformity (updated) -Kunshan Jiehong
Annex A.9 – Technical Specifications and QMS Certifications- Kunshan Jiehong
Between 8 July 2020 and 28 August 2020, DHSC paid £121,999,219.20 to Medpro in consideration under the Contract for the Gowns.
- 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
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