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UK-Loughborough: Macchinari vari per impieghi speciali

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Informazioni generali

Paese :   Gran Bretagna
Città/Luogo:   LOUGHBOROUGH
Numero di Bandi di Gara/Contratti:   eu:205101-2008
Data di pubblicazione :   Aug 7, 2008
Data limite :   Sept 18, 2008
Compratori:   LOUGHBOROUGH UNIVERSITY
Lingua Originale:   Inglese

Le Informazioni Del Contatto

Indirizzo :   LOUGHBOROUGH UNIVERSITY
LOUGHBOROUGH , Leicestershire, Rutland and Northamptonshire  
Gran Bretagna
Sito Web :   https://www.in-tendhost.com/loughborouni/

Beni, lavori e servizi

 

Testo originale

     view in:

Tipo del bando digara: 21M0
-
Avviso di gara
Regolamento dell'acquisizione
: Comunità europee, con partecipazione dei paesi AAP
Pubblicazione del bollettino ufficiale dell'Unione Europea : 152/2008
, #
205101-2008
Natura del contratto : Appalto di forniture
Tipo di procedura

: Dialogo competitivo
Tipo d'offerta richiesta: Offerta globale
Criteri d'aggiudicazione : Offerta economicamente più vantaggiosa

Sommario:
BANDO DI GARA
Forniture
SEZIONE I: AMMINISTRAZIONE AGGIUDICATRICE
I.1) DENOMINAZIONE, INDIRIZZI E PUNTI DI CONTATTO: Loughborough
University, Purchasing Office, Contattare: Steve Warren, UK-Loughborough
LE11 3TU. Tel. 015 09 22 36 25. E-mail: S.R.Warren@lboro.ac.uk.
Indirizzo(i) internet:
Amministrazione aggiudicatrice: https://www.in-tendhost.com/loughborouni/.
Ulteriori informazioni sono disponibili presso: I punti di contatto sopra
indicati.
Il capitolato d'oneri e la documentazione complementare (inclusi i
documenti per il dialogo competitivo e per il sistema dinamico di
acquisizione) sono disponibili presso: I punti di contatto sopra indicati.
Le offerte o le domande di partecipazione vanno inviate a: I punti di
contatto sopra indicati.
II.1) DESCRIZIONE
II.1.6) CPV (Vocabolario comune per gli appalti): 29560000, 33000000,
33253450.
Descrizione: Macchinari vari per impieghi speciali.
Apparecchiature mediche e di laboratorio, strumenti ottici e di
precisione, orologi, prodotti farmaceutici e relativi materiali medici
correnti.
Apparecchi per analisi biochimiche.
SEZIONE IV: PROCEDURA
IV.3) INFORMAZIONI DI CARATTERE AMMINISTRATIVO
IV.3.3) Condizioni per ottenere il capitolato d'oneri e la documentazione
complementare oppure il documento descrittivo Termine per il ricevimento
delle richieste di documenti o per l'accesso ai documenti: 11.9.2008 -
12:00.
IV.3.4) Termine per il ricevimento delle offerte o delle domande di
partecipazione: 18.9.2008 - 12:00.
IV.3.6) Lingue utilizzabili per la presentazione delle offerte/domande di
partecipazione: Inglese.


Testo originale
:
CONTRACT NOTICE
Supplies
SECTION I: CONTRACTING AUTHORITY
I.1) NAME, ADDRESSES AND CONTACT POINT(S): Loughborough University,
Purchasing Office, Contact: Steve Warren, UK-Loughborough LE11 3TU. Tel.
015 09 22 36 25. E-mail: S.R.Warren@lboro.ac.uk.
Internet address(es):
General address of the contracting authority:
https://www.in-tendhost.com/loughborouni/.
Further information can be obtained at: As in above-mentioned contact
point(s).
Specifications and additional documents (including documents for
competitive dialogue and a dynamic purchasing system) can be obtained at:
As in above-mentioned contact point(s).
Tenders or requests to participate must be sent to: As in above-mentioned
contact point(s).
I.2) TYPE OF THE CONTRACTING AUTHORITY AND MAIN ACTIVITY OR ACTIVITIES:
Body governed by public law.
Education.
The contracting authority is purchasing on behalf of other contracting
authorities: no.
SECTION II: OBJECT OF THE CONTRACT
II.1) DESCRIPTION
II.1.1) Title attributed to the contract by the contracting authority:
LU00250 - Supply and Installation of a GMP Automated Production System for
Somatic Cell Therapeutic Medicinal Product.
II.1.2) Type of contract and location of works, place of delivery or of
performance: Supplies.
Purchase.
Main place of delivery: Loughborough University.
NUTS code: UKF2.
II.1.3) The notice involves: A public contract.
II.1.5) Short description of the contract or purchase(s): Loughborough
University wishes to purchase an automated system (complete with
installation and support services) designed to, in an EU GMP
Classification Grade A environment, aseptically culture, expand,
differentiate (as necessary by the addition of reagents) and harvest
adherent cells to be used in the GMP/cGMP manufacture of clinical trial
(phases I and II) and phase III and licensed product batches of somatic
cell therapeutic medicinal products. These products are classified as
ATMPs - advanced therapy medicinal products, as defined in the EU
Regulation2 and HCT/Ps -human cells, tissues and cellular and tissue based
products by the FDA3. Products will include cells and cell lines for
allogeneic therapy and autologous cells for individual patients. The
system must be capable of processing cells from multiple individual
patients concurrently. The process must provide full traceability of
original cell cultures and all daughters.
The resulting product and its environment will need to be fully compliant
with all appropriate legislation, for example the Medicines and Healthcare
Regulatory Agency (MHRA) within the UK.
We are utilising the competitive dialogue procedure because our
requirements are in their formative stages and this coupled with the
necessary interaction between bidders, ourselves and all regulatory
bodies, will necessitate competitive dialogue prior to determination of
requirements and subsequent priced tenders.
II.1.6) Common procurement vocabulary (CPV): 29560000, 33000000,
33253450.
II.1.7) Contract covered by the Government Procurement Agreement (GPA):
Yes.
II.1.8) Division into lots: No.
II.1.9) Variants will be accepted: Yes.
II.2) QUANTITY OR SCOPE OF THE CONTRACT
II.2.1) Total quantity or scope:
II.2.2) Options: No.
SECTION III: LEGAL, ECONOMIC, FINANCIAL AND TECHNICAL INFORMATION
III.1) CONDITIONS RELATING TO THE CONTRACT
III.1.1) Deposits and guarantees required: Refer to tender documents in
due course.
III.1.2) Main financing conditions and payment arrangements and/or
reference to the relevant provisions regulating them: .
III.1.3) Legal form to be taken by the group of economic operators to
whom the contract is to be awarded: The University reserves the right to
require any grouping or consortium of contractors to adopt a particular
legal form, or to require a single contractor to assume primary liability,
or to require that each party assumes joint and several liability
irrespective of the form of the grouping or consortium.
III.1.4) Other particular conditions to which the performance of the
contract is subject: No.
III.2) CONDITIONS FOR PARTICIPATION
III.2.1) Personal situation of economic operators, including requirements
relating to enrolment on professional or trade registers: Information and
formalities necessary for evaluating if requirements are met: As set out
in the descriptive document including pre-qualification questionnaire
which is viewable from the address in section I.1.
III.2.2) Economic and financial capacity: Information and formalities
necessary for evaluating if requirements are met: Suppliers are requested
to submit the past three years audited accounts complete with summarised
financial information. Refer to the descriptive document including
pre-qualification questionnaire.
III.2.3) Technical capacity: Information and formalities necessary for
evaluating if requirements are met: Suppliers will be requested to produce
evidence of technical capacity to deliver the requirements of the
contract.
Minimum level(s) of standards possibly required: In particular all
suppliers must supply full details of similar supplies/services (that echo
our requirement) undertaken with at least three other customers who may be
contacted so seek references.
III.2.4) Reserved contracts: No.
III.3) CONDITIONS SPECIFIC TO SERVICES CONTRACTS
III.3.1) Execution of the service is reserved to a particular profession:
No.
III.3.2) Legal entities should indicate the names and professional
qualifications of the staff responsible for the execution of the service:
No.
SECTION IV: PROCEDURE
IV.1) TYPE OF PROCEDURE
IV.1.1) Type of procedure: Competitive dialogue.
IV.1.2) Limitations on the number of operators who will be invited to
tender or to participate: Envisaged minimum number: 3. Maximum number: 5.
IV.1.3) Reduction of the number of operators during the negotiation or
dialogue: Recourse to staged procedure to gradually reduce the number of
solutions to be discussed or tenders to be negotiated no.
IV.2) AWARD CRITERIA
IV.2.1) Award criteria: The most economically advantageous tender in
terms of the criteria stated in the specifications, in the invitation to
tender or to negotiate or in the descriptive document.
IV.2.2) An electronic auction will be used: No.
IV.3) ADMINISTRATIVE INFORMATION
IV.3.1) File reference number attributed by the contracting authority:
LU00250.
IV.3.2) Previous publication(s) concerning the same contract: No.
IV.3.3) Conditions for obtaining specifications and additional documents
or descriptive documentTime limit for receipt of requests for documents or
for accessing documents: 11.9.2008 - 12:00.
Payable documents: no.
IV.3.4) Time-limit for receipt of tenders or requests to participate:
18.9.2008 - 12:00.
IV.3.6) Language(s) in which tenders or requests to participate may be
drawn up: English.
IV.3.8) Conditions for opening tenders: Persons authorised to be present
at the opening of tenders: no.
SECTION VI: COMPLEMENTARY INFORMATION
VI.1) THIS IS A RECURRENT PROCUREMENT: No.
VI.2) CONTRACT RELATED TO A PROJECT AND/OR PROGRAMME FINANCED BY EU
FUNDS: No.
VI.3) ADDITIONAL INFORMATION: Suppliers interested in applying for
documents must do so by applying on line at the address stated in I.1 and
repeated again below:
https://www.in-tendhost.com/loughborouni/.
VI.4) PROCEDURES FOR APPEAL
VI.4.1) Body responsible for appeal procedures: Body responsible for
mediation procedures:
VI.4.2) Lodging of appeals: Precise information on deadline(s) for
lodging appeals: This authority will incorporate a minimum 10 calendar day
standstill period at the point information on the award of the contract is
communicated to tenderers. This period allows unsuccessful tenderers to
seek further debriefing from the contracting authority before the contract
is entered into. Applicants have 2 working days from notification of the
award decision to request additional debriefing and that information has
to be provided a minimum of 3 working days before expiry of the standstill
period. Such additional information should be requested from the address
in Section I.1.
If an appeal regarding the award of a contract has not been successfully
resolved the Public Contracts Regulations 2006 (SI 2006 No 5) provide for
aggrieved parties who have been harmed or are at risk of harm by a breach
of the rules to take action in the High Court. Any such action must be
brought promptly (generally within 3 months). Where a contract has not
been entered into the court may order the settling aside of the award
decision or order the authority to amend any document and may award
damages. If the contract has been entered into the court may only award
damages.
VI.4.3) Service from which information about the lodging of appeals may
be obtained:
VI.5) DATE OF DISPATCH OF THIS NOTICE: 4.8.2008.


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