Master Alliance Provisions Guide (MAPGuide)

National Health Service (NHS) – Pfizer/Shionogi, Antibiotic Supply Agreement

  • Business model | Product supply

SCHEDULE 1: KEY PROVISIONS

12. Purchase Orders

12.1 The Authority or Purchasing Authority (as the case may be) shall issue a Purchase Order to the Supplier in respect of any Goods to be supplied to the Authority or Purchasing Authority (as the case may be) under this Contract. The Supplier shall comply with the terms of such Purchase Order as a term of this Contract. For the avoidance of doubt, any actions or work undertaken by the Supplier under this Contract prior to the receipt of a Purchase Order covering the relevant Goods shall be undertaken at the Supplier’s risk and expense and the Supplier shall only be entitled to invoice for Goods covered by a valid Purchase Order.

24. Performance

24.1 The parties agree that Schedule 10 shall have effect.

24.2 With effect from the Commencement Date the Supplier must ensure that it performs this Contract at all times in a manner which meets or exceeds the Performance Levels.

24.3 Notwithstanding any of its other obligations under this Contract, the Supplier must monitor its performance against the Performance Levels in accordance with the Performance Monitoring System. The Supplier must provide the Authority with a report as soon as reasonably practicable (but in any event within four (4) weeks of the end of each Quarter) specifying, , the Supplier’s performance against each of the Performance Levels in accordance with the timescales set out in Annex B of Schedule 10, including full details of any failure to meet the Performance Levels and a statement of any Performance Credits due against each Performance Level and in aggregate.

24.4 The Authority shall be entitled to audit the Supplier’s compliance with clause 24.2 under clause 24 of Schedule 2.

24.5 If Supplier’s performance of this Contract does not comply with the Key Performance Levels or else if no report (or a report that does not detail all Key Performance Levels that were due to be measured) pursuant to Clause 24.3 of this Schedule 1 is provided by the Supplier (in which case there will be a presumption that all Performance Levels were at Red Level or all such Performance Levels in respect of which the report is incomplete, were at Red Level), the Authority shall be entitled to a Performance Credit payable by the Supplier in respect of those Performance Levels as set out in Schedule 10.

25.6 Performance Credits shall be a debt due by the Supplier to the Authority for the Quarter to which they relate which the Authority may set off against any amount the Authority owes to the Supplier. Performance Credits shall be deducted by the Supplier from the Contract Price in the invoice issued in accordance with Commercial Schedule following the determination of the Performance Credits due in accordance with the reports provided pursuant to clause 24.3. Any Performance Credits not deducted in accordance with this clause 24.6 shall immediately be payable to the Authority as a liquidated debt.

24.7 Nothing in this clause 24 shall restrict the Authority’s right to claim damages or any other remedy or to terminate this Contract under clause 15 of Schedule 2.

27.8 Without prejudice to any of its other rights under this Contract, the Authority shall be entitled to request a draft correction report from the Supplier in the event of a delay or failure in the delivery, completion or performance of any part of the Supplier’s obligations under this Contract, including any Amber Level or Red Level rating for any of the Performance Levels (a “Correction Report“). The draft Correction Report must identify the causes of the relevant delay or failure and the steps that the Supplier proposes to take to rectify (where possible) or mitigate the effects of such delay or failure.

24.9 The draft Correction Report must be submitted to the Authority for its approval (such approval not to be unreasonably withheld or delayed) promptly after the Supplier becomes aware of any such delay or failure in the delivery, completion or performance of any part of this Contract or promptly following a request from the Authority. The Supplier must incorporate into the revised draft of the Correction Report all reasonable requests or comments raised by the Authority to prevent the recurrence of any delay or failure in the Supplier’s performance of this Contract.

24.10 The Supplier must, at its own cost, promptly take the steps identified in the Correction Report approved by the Authority to prevent the recurrence of any delay or failure in the Supplier’s performance of this Contract.

27. Continuity and Brexit

27.1 The Supplier must ensure, without prejudice to the other provisions of the Contract, that the Goods are available for supply throughout the Term and are licensed for use in England.

27.2 Without prejudice to the generality of Key Provision 27.1:

27.2.1 Brexit means the withdrawal of the United Kingdom from the European Union and

27.2.2 any related circumstances, events, changes or requirements.

27.3 The Supplier must take all steps necessary to ensure a seamless transition between any licensing and regulatory regimes which occur in anticipation of, during or as a result of Brexit so that there is no interruption in supply of the Goods.

27.4 The Supplier must take all other steps to ensure that there is a continuity of supply of Goods notwithstanding Brexit, including, but without limitation, complying with the Secretary of State for Health and Social Care’s letter of 23rd August 2018 headed ‘EU Exit – Human medicines supply in a March 2019 ‘no deal’ scenario’ and any further relevant guidance published by the UK Government in relation to Brexit.

SCHEDULE 2: GENERAL TERMS AND CONDITIONS

1. Supply of Goods

1.1 The Supplier shall supply the Goods ordered by the Authority or any Purchasing Authority (as the case may be) under this Contract:

1.1.1 promptly and in any event within any time limits as may be set out in this Contract;

1.1.2 in accordance with all other provisions of this Contract;

1.1.3 using reasonable skill and care in their delivery;

1.1.4 using reasonable skill and care in their installation, associated works and training to the extent that such installation, works or training is a requirement of this Contract;

1.1.5 in accordance with any quality assurance standards as set out in the Key Provisions and/or the Specification and Tender Response Document;

1.1.6 in accordance with the Law and with Guidance;

1.1.7 in accordance with Good Industry Practice;  1.1.8 in accordance with the Policies; and

1.1.9 in a professional and courteous manner. In complying with its obligations under this Contract, the Supplier shall, and shall procure that all Staff shall, act in accordance with the NHS values as set out in the NHS Constitution from time to time.

1.2 The Supplier shall comply fully with its obligations set out in the Specification and Tender Response Document (to include, without limitation, the Performance Levels and all obligations in relation to the quality, performance characteristics, supply, delivery and installation and training in relation to use of the Goods).

1.3 Unless otherwise agreed by the Parties in writing, the Goods shall be new, consistent with any sample, and shall comply with any applicable specification set out in this Contract (to include, without limitation, the provisions of the Authority’s requirements set out in the Specification and Tender Response Document and the Supplier’s response to such requirements) and any applicable manufacturers’ specifications.

1.4 The Supplier shall ensure that all relevant consents, authorisations, licences and accreditations required to supply the Goods are in place prior to the delivery of any Goods to the Authority.

1.5 If there are any incidents that in any way relate to or involve the use of the Goods by the Authority or any Purchasing Authority, the Supplier shall cooperate fully with the Authority or any Purchasing Authority (as the case may be) in relation to the Authority’s or any Purchasing Authority’s (as the case may be) application of the Policies on reporting and responding to all incidents, including serious incidents requiring investigation, and shall respond promptly to any reasonable and proportionate queries, questions and/or requests for information that the Authority or any Purchasing Authority (as the case may be) may have in this context in relation to the Goods.

1.6 If there are any quality, performance and/or safety related reports, notices, alerts or other communications issued by the Supplier or any regulatory or other body in relation to the Goods, the Supplier shall promptly provide the Authority and any Purchasing Authority with a copy of any such reports, notices, alerts or other communications.

4. Inspection, rejection, return and recall

4.1 As relevant and proportionate to the Goods in question and subject to reasonable written notice, the Supplier shall permit any person authorised by the Authority, to inspect work being undertaken in relation to the Goods and/or the storage facilities used in the storage of the Goods at all reasonable times at the Supplier’s premises or at the premises of any Sub–contractor or agent of the Supplier in order to confirm that the Goods are being manufactured and/or stored in accordance with Good Industry Practice and in compliance the requirements of this Contract and/or that stock holding and quality assurance processes are in accordance with the requirements of this Contract.

4.2 Without prejudice to the provisions of Clause 4.6 of this Schedule 2 and subject to Clause 4.7 of this Schedule 2, the Authority shall visually inspect the Goods within a reasonable time following delivery (or such other period as may be set out in the Key Provisions, if any) and may by written notice reject any Goods found to be damaged or otherwise not in accordance with the requirements of this Contract (“Rejected Goods”). The whole of any delivery may be rejected if a reasonable sample of the Goods taken indiscriminately from that delivery is found not to conform in all material respects to the requirements of the Contract.

4.3 Without prejudice to the provisions of Clause 4.5 of this Schedule 2, upon the rejection of any Goods in accordance with Clauses 4.2 and/or 4.6 of this Schedule 2, the Supplier shall at the Authority’s written request:

4.3.1 collect the Rejected Goods at the Supplier’s risk and expense within ten (10) Business Days of issue of written notice from the Authority rejecting the Goods; and

4.3.2 without extra charge, promptly (and in any event within twenty (20) Business Days or such other time agreed by the Parties in writing acting reasonably) supply replacements for the Rejected Goods to the Authority subject to the Authority not cancelling its purchase obligations in accordance with Clause 4.5 of this Schedule 2.

If the Supplier requests and the Authority accepts that the Rejected Goods should be disposed of by the Authority rather than returned to the Supplier, the Authority reserves the right to charge the Supplier for the costs associated with the disposal of the Rejected Goods and the Supplier shall promptly pay any such costs.

4.4 Risk and title in respect of any Rejected Goods shall pass to the Supplier on the earlier of: (a) collection by the Supplier in accordance with Clause 4.3 of this Schedule 2; or (b) immediately following the expiry of ten (10) Business Days from the Authority issuing written notification rejecting the Goods. If Rejected Goods are not collected within ten (10) Business Days of the Authority issuing written notification rejecting the Goods, the Authority may return the Rejected Goods at the Supplier’s risk and expense and charge the Supplier for the cost of storage from the expiry of ten (10) Business Days from the date of notification of rejection.

4.5 Where the Authority rejects any Goods in accordance with Clauses 4.2 and/or 4.6 of this Schedule 2 and the Authority no longer requires replacement Goods, the Authority may by written notice cancel its purchase obligations in relation to such quantity of Rejected Goods. Should the Authority have paid for such Rejected Goods the Supplier shall refund such payment to the Authority within thirty (30) days of the Authority cancelling such purchase obligations and informing the Supplier that the Authority does not require replacements for such Rejected Goods.

4.6 Without prejudice to any other provisions of this Contract or any other warranties or guarantees applicable to the Goods supplied and subject to Clause 4.7 of this Schedule 2, if at any time following the date of the delivery of any Goods, all or any part of such Goods are found to be defective or otherwise not in accordance with the requirements of this Contract (“Defective Goods”), the Supplier shall, at the Authority’s discretion:

4.6.1 upon written request and without charge, promptly (and in any event within twenty (20) Business Days or such other time agreed by the Parties in writing acting reasonably) remedy the deficiency by repairing such Defective Goods; or

4.6.2 upon written notice of rejection from the Authority, treat such Defective Goods as Rejected Goods in accordance with Clauses 4.2 to 4.5 of this Schedule 2.

6. Business continuity

6.1 The Supplier shall use reasonable endeavours to ensure its Business Continuity Plan operates effectively alongside the Authority’s business continuity plan (and that of each Purchasing Authority) where relevant to the supply of the Goods. The Supplier shall also ensure that its Business Continuity Plan complies on an ongoing basis with any specific business continuity requirements, as may be set out in the Specification and Tender Response Document.

6.2 Throughout the Term, the Supplier will ensure its Business Continuity Plan provides for continuity during a Business Continuity Event. The Supplier confirms and agrees such Business Continuity Plan details and will continue to detail robust arrangements that are reasonable and proportionate to:

6.2.1 the criticality of this Contract to the Authority; and

6.2.2 the size and scope of the Supplier’s business operations, regarding continuity of the supply of Goods during and following a Business Continuity Event.

6.3 The Supplier shall test its Business Continuity Plan at reasonable intervals, and in any event no less than once every twelve (12) months or such other period as may be agreed between the Parties taking into account the criticality of this Contract to the Authority and the size and scope of the Supplier’s business operations. The Supplier shall promptly provide to the Authority, at the Authority’s written request, copies of its Business Continuity Plan, reasonable and proportionate documentary evidence that the Supplier tests its Business Continuity Plan in accordance with the requirements of this Clause 6.3 of this Schedule 2 and reasonable and proportionate information regarding the outcome of such tests. The Supplier shall provide to the Authority a copy of any updated or revised Business Continuity Plan within fourteen (14) Business Days of any material update or revision to the Business Continuity Plan.

6.4 The Authority may suggest reasonable and proportionate amendments to the Supplier regarding the Business Continuity Plan at any time. Where the Supplier, acting reasonably, deems such suggestions made by the Authority to be relevant and appropriate, the Supplier will incorporate into the Business Continuity Plan all such suggestions made by the Authority in respect of such Business Continuity Plan. Should the Supplier not incorporate any suggestion made by the Authority into such Business Continuity Plan it will explain the reasons for not doing so to the Authority.

6.5 Should a Business Continuity Event occur at any time, the Supplier shall implement and comply with its Business Continuity Plan and provide regular written reports to the Authority on such implementation.

6.6 During and following a Business Continuity Event, the Supplier shall use reasonable endeavours to continue to supply the Goods in accordance with this Contract.

SCHEDULE 5: SPECIFICATION AND TENDER RESPONSE DOCUMENT

1. Delivery

  • The Suppliers shall maintain a 24 hour delivery service between Monday & Friday (orders placed after 17:00 on Thursday may be delivered on Monday) plus an emergency service to facilitate weekend or out of hours deliveries if required by the Purchasing Authority.
  • Any Goods supplied by the Supplier shall have at least 12 months remaining shelf life at the date of delivery.

2. Surety of Supply

  • The Suppliers shall maintain within the supply chain, sufficient capacity to satisfy 30 months of the anticipated demand in England, reflecting England’s usage in comparison to the rest of the world.
  • The Suppliers shall maintain physically within England, sufficient stock to satisfy at least 6 months of the anticipated demand in England.
  • The Suppliers shall maintain supply capability and capacity to replenish stock in the England within 90 days of order placement.

3. Supplier Commitments

  • The Supplier shall comply with the Supplier Commitments specified in Table 2 of Schedule 10.

 

SCHEDULE 10: PERFORMANCE LEVELS AND PERFORMANCE CREDITS

3. Performance Levels and Key Performance Levels

3.1 Not Used

3.2 Performance Levels: Table 1, Annex A to this Schedule sets out the required Performance Levels for various aspects of this Contract.

3.3 Warranty: The Supplier warrants and undertakes that each report provided by the Supplier pursuant to (i) clause 24.3 of this Contract and (ii) Annex B of this Schedule 10 will be accurate in all material respects.

3.4 Performance Bands: Measured performance shall fall into three colour–coded bands, the colour coding of which is designed to help identify problem areas for management attention. Satisfactory performance will be categorised as “Green Level” and a failure to deliver an element of the Performance Requirements will be classified as either “Amber Level or Red Level” depending on the degree of failure.

3.5 Performance Credits: Performance Credits will be calculated and redeemable as set out at Clause 6 below.

4. Escalation

4.1 Escalation of problems: The Quarterly Reports produced by the Supplier will be used as a management tool. Any problems causing any of the Performance Levels to be rated Red Level shall be considered worthy of serious management attention by the Authority and Supplier, but the Supplier will retain the primary obligation to rectify such problems.

5. Correction reports: The Supplier must prepare a Correction Report in the circumstances set out in clause 24.8 of Schedule 1 of this Contract.

6. Calculation of Performance Credits

6.1 Application of Performance Credits: The parties agree that:

i. Performance Credits are to be calculated on a Quarterly basis save for Performance Level number 2 (as specified in Table 1, Annex A to this Schedule), in respect of which Performance Credits are to be calculated on a monthly basis.

ii. Performance Failure Points, as specified in Table 1, Annex A to this Schedule 10, will accrue for each Red Level status or Amber Level status achieved in a previous Performance Period.

6.2 Amount of Performance Credit: Further:

i. a Red Level status will be applied to the Supplier’s performance against any Performance Level which, calculated as an average over the relevant Performance Period, has been Amber Level for two or more consecutive Performance Periods.

ii. the number of Performance Failure Points accrued by the Supplier during the relevant period shall be totalled for all of the Performance Levels to arrive at the number of points for the Performance Period. The total number of Performance Failure Points shall be converted into a monetary figure.

6.3 Value attributable to Performance Failure Points: Each Performance Failure Point shall be worth 0.001 of the Contract Price.

6.4 Redemption of Performance Credits: Performance Credits shall be redeemed in accordance with the procedure set out in clause 24.6 of Schedule 1 of this Contract.

6.5 Double Counting: To the extent that the same event triggers Performance Credits under Performance Levels 3 and 4 or 5, 6 or 7, the Authority will only claim the largest Performance Credit.

6.6 Authority right to waive: Without having any obligation or creating any expectation that it will do so, the Authority may from time to time waive any entitlement to Performance Credits. To be valid, any such waiver shall be in writing expressly referring to the Performance Credits that have accrued.