Liverpool School of Tropical Medicine: LW114 Manufacturing for Phase II Clinical trial

  Liverpool School of Tropical Medicine has published this notice through Delta eSourcing

Notice Summary
Title: LW114 Manufacturing for Phase II Clinical trial
Notice type: Voluntary Ex-Ante Transparency Notice
Authority: Liverpool School of Tropical Medicine
Nature of contract: Supplies
Procedure: Award without prior publication
Short Description: Manufacture and Supply of Phase II Clinical GMP pneumococcal protein Drug Substance and Drug Product
Published: 30/07/2024 15:42

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UK-Liverpool: Clinical products.

Preliminary Questions
   This notice is published by:
   Directive 2014/24/EU

Section I: Contracting authority/entity

I.1) Name and addresses
       Liverpool School of Tropical Medicine
       Pembroke Place, Liverpool, Liverpool, L3 5QA, United Kingdom
       Tel. +44 1517053152, Email: purchasing@lstmed.ac.uk
       Contact: Procurement
       Main Address: http://www.lstmed.ac.uk/, Address of the buyer profile: http://www.lstmed.ac.uk/
       NUTS Code: UKD72

I.4) Type of the contracting authority (in the case of a notice published by a contracting authority)
      Body governed by public law

I.5) Main Activity (in the case of a notice published by a contracting authority)
      Education


Section II: Object

II.1) Scope of the procurement
   
   II.1.1) Title: LW114 Manufacturing for Phase II Clinical trial.
      Reference number: LW114
      
   II.1.2) Main CPV code:
      33698000 - Clinical products.
   
   II.1.3) Type of contract: SUPPLIES
   
   II.1.4) Short Description: Manufacture and Supply of Phase II Clinical GMP pneumococcal protein Drug Substance and Drug Product
   
   II.1.6) Information about lots
      This contract is divided into lots: No

   II.1.7) Total value of the procurement (excluding VAT)
      Value: 1,213,000      
      Currency: EUR


II.2) Description

   II.2.2) Additional CPV codes:
      Not provided

   II.2.3) Place of performance:
      PT PORTUGAL
   
   
   II.2.4) Description of the procurement:
    Manufacture and Supply of Phase II Clinical GMP pneumococcal protein Drug Substance and Drug Product    
   
   II.2.5) Award criteria
   (Directive 2014/24/EU / Directive 2014/25/EU)
               
   Price - Weighting: 10
         
      
      
   II.2.11) Information about options:
      Options:    No       
   
   II.2.13) Information about European Union funds:
      The procurement is related to a project and/or programme financed by European Union funds:    No

   II.2.14) Additional information:
    Not provided    
      
Section IV: Procedure

IV.1) Description
   
   IV.1.1) Type of procedure: Award of a contract without prior publication of a call for competition in the Official Journal of the European Union in the cases listed below         
   
   IV.1.3) Information about framework agreement
         The procurement involves the establishment of a framework agreement: No    
   
   IV.1.8) Information about the Government Procurement Agreement (GPA)
         The procurement is covered by the Government Procurement Agreement: No
         
IV.2)Administrative Information

   IV.2.1) Previous publication concerning this procedure:
      Notice number in OJ S: Not provided       
   
Section V: Award Of Contract/Concession
      
Award of Contract/Concession No: 1
Contract No: Not Provided    Lot Number: Not Provided    Title: Not Provided

V.2) Award of contract/concession
      
      V.2.1) Date of contract award decision: 26/07/2024.
      
      V.2.2) Information about tenders
      The contract has been awarded to a group of economic operators: No .

      V.2.3) Name and address of the contractor/concessionaire, No. 1:
          Genibet Biopharmaceuticals, N/A
       at Edifício da Instalação Piloto do iBET, Av. da República – Quinta do Marquês, 2781-901, Oeiras, Portugal
       NUTS Code: PT
   The contractor/concessionaire will be an SME: No    
   
         
      V.2.4) Information on value of the contract/lot/concession:
         Initial estimated total value of the contract: 1,213,000          
         Total value of the contract/lot/concession 1,213,000         
         Currency: EUR

      V.2.5) Information about subcontracting:
         The contract is likely to be subcontracted: No          


Section VI: Complementary Information

   VI.3) Additional Information:
      To view this notice, please click here:
https://www.delta-esourcing.com/delta/viewNotice.html?noticeId=872807499
GO-2024730-PRO-27088682 TKR-2024730-PRO-27088681   
   VI.4) Procedures for review
   
      VI.4.1) Review Body
          Liverpool School of Tropical Medicine
       Pembroke Place, Liverpool, L3 5QA, United Kingdom
       Tel. +44 1517053237
   
      V1.4.2) Body responsible for mediation procedures:
                Liverpool School of Tropical Medicine
       Pembroke Place, Liverpool, Liverpool, L3 5QA, United Kingdom
       Tel. +44 1517053237, Email: duncan.preston@lstmed.ac.uk.

      VI.4.3) Review procedure
      Not Provided    
      
      VI.4.4) Service from which information about the review procedure may be obtained
          Liverpool School of Tropical Medicine
       Pembroke Place, Liverpool, Liverpool, L3 5QA, United Kingdom
       Tel. +44 1517053237, Email: purchasing@lstmed.ac.uk
   
   VI.5) Date of dispatch of this notice: 30/07/2024


Annex D1 - General Procurement
Justification for the award of the contract without prior publication of a call for competition in the Official Journal of the European Union
Directive 2014/24/EU


2. Other justification for the award of the contract without prior publication of a call for competition in the Official Journal of the European Union

   The procurement falls outside the scope of application of the directive: Yes

3. Explanation

   Please explain in a clear and comprehensive manner why the award of the contract without prior publication in the Official Journal of the European Union is
   lawful, by stating the relevant facts and, as appropriate, the conclusions of law in accordance with the directive: (500 words maximum)
   In seeking an appropriate manufacturing partner for this early stage clinical programme, LSTM approached several potential suppliers with a request for proposal. An unusual aspect of the programme is the small volume required which the majority of the suppliers could not accommodate within their GMP facility. Of the suppliers approached, only Genibet were able to match the requirements, reducing the risk, but also allowing the proposal to be provided within the budget available. There is also time pressure to select a partner for the rest of the programme to be able to progress to schedule.
   

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