Section one: Contracting authority
one.1) Name and addresses
University of Dundee
Procurement, 3rd Floor, Tower Building, Nethergate
Dundee
DD1 4HN
Contact
Mary Kirkpatrick
Telephone
+44 1382386604
Country
United Kingdom
NUTS code
UKM71 - Angus and Dundee City
Internet address(es)
Main address
Buyer's address
https://www.publiccontractsscotland.gov.uk/search/Search_AuthProfile.aspx?ID=AA00105
one.2) Information about joint procurement
The contract is awarded by a central purchasing body
one.3) Communication
The procurement documents are available for unrestricted and full direct access, free of charge, at
www.publiccontractsscotland.gov.uk
Additional information can be obtained from the above-mentioned address
Tenders or requests to participate must be submitted electronically via
www.publiccontractsscotland.gov.uk
Electronic communication requires the use of tools and devices that are not generally available. Unrestricted and full direct access to these tools and devices is possible, free of charge, at
www.publiccontractsscotland.gov.uk
one.4) Type of the contracting authority
Body governed by public law
one.5) Main activity
Education
Section two: Object
two.1) Scope of the procurement
two.1.1) Title
One-off Contract for Supply of Drug Handling Services in respect of GREAT-2 Clinical Trial (Overlabelling, STorage & Distribution)
Reference number
UoD-LAB426-OO-2022
two.1.2) Main CPV code
- 73110000 - Research services
two.1.3) Type of contract
Services
two.1.4) Short description
One-off Contract for the Over Labelling, Storage & Distribution of Research Drugs to Clinical Trial Sites (20 in UK and 10 in Spain)
two.1.5) Estimated total value
Value excluding VAT: £250,000
two.1.6) Information about lots
This contract is divided into lots: No
two.2) Description
two.2.2) Additional CPV code(s)
- 33600000 - Pharmaceutical products
- 60000000 - Transport services (excl. Waste transport)
- 63120000 - Storage and warehousing services
- 79824000 - Printing and distribution services
two.2.3) Place of performance
NUTS codes
- UK - United Kingdom
- ES - Spain
Main site or place of performance
20 Trial Sites in Uk and 10 in Spain.
two.2.4) Description of the procurement
The objective of this procurement is to appoint a single Service Provider for the secondary labelling and packaging into kits of commercially supplied IMP vials and matching placebo vials, and their onward distribution to trial sites, as detailed below:
- Importer of Record: act as importer of record to the
UK.
- IMP to be provided by USA manufacturer and supplied
in naked vials which will be individually labelled
and packaged; a bivalent, bispecific human
immunoglobulin G1 kappa monoclonal antibody
- Placebo to be provided by USA manufacturer and
supplied in naked vials which will be individually
labelled and packaged
- Number of participants – Target recruitment is 90
participants
- Number of sites and countries:
UK: 20-25 sites
Spain: 5-10 sites
- Labelling:
Total number of vials: 1400, shipped in 2 batches
Over label packs (IMP and placebo), over labelling
to be done at 2-8C
Labelling options: Booklet label with two languages
(English and Spanish) on each vial/carton
two.2.5) Award criteria
Quality criterion - Name: Project Management & Communication / Weighting: 4
Quality criterion - Name: Randomisation & Drug Management / Weighting: 10
Quality criterion - Name: Labelling & Secondary Packaging / Weighting: 6
Quality criterion - Name: Storage of Packaged Drugs/Placebo Kits / Weighting: 4
Quality criterion - Name: Pack Distribution to Trial Sites / Weighting: 4
Quality criterion - Name: Testing & Release / Weighting: 2
Quality criterion - Name: Audit Control & Record Keeping / Weighting: 3
Quality criterion - Name: Experience of Servicing Similar Contracts / Weighting: 4
Quality criterion - Name: Business Continuity/Disaster Recovery Plan / Weighting: 3
Price - Weighting: 60
two.2.6) Estimated value
Value excluding VAT: £250,000
two.2.7) Duration of the contract, framework agreement or dynamic purchasing system
Duration in months
24
This contract is subject to renewal
Yes
Description of renewals
Could be extended beyond 24 months in event of delays in clinical trails due to circumstances outwith the University's control
two.2.10) Information about variants
Variants will be accepted: No
two.2.11) Information about options
Options: No
two.2.13) Information about European Union Funds
The procurement is related to a project and/or programme financed by European Union funds: No
Section three. Legal, economic, financial and technical information
three.1) Conditions for participation
three.1.1) Suitability to pursue the professional activity, including requirements relating to enrolment on professional or trade registers
List and brief description of conditions
All bidders will be required to have a MHRA Certificate of GMP Compliance of a Manufacturer/Manufacturer’s Authorisation – IMP with named Qualified Person (QP)
three.1.2) Economic and financial standing
Selection criteria as stated in the procurement documents
three.1.3) Technical and professional ability
Selection criteria as stated in the procurement documents
three.2) Conditions related to the contract
three.2.2) Contract performance conditions
As detailed in tender documents.
Section four. Procedure
four.1) Description
four.1.1) Type of procedure
Open procedure
four.1.8) Information about the Government Procurement Agreement (GPA)
The procurement is covered by the Government Procurement Agreement: Yes
four.2) Administrative information
four.2.2) Time limit for receipt of tenders or requests to participate
Date
29 July 2022
Local time
12:00pm
four.2.4) Languages in which tenders or requests to participate may be submitted
English
four.2.6) Minimum time frame during which the tenderer must maintain the tender
Duration in months: 3 (from the date stated for receipt of tender)
four.2.7) Conditions for opening of tenders
Date
29 July 2022
Local time
12:00pm
Place
Online via PCS
Information about authorised persons and opening procedure
Mary Kirkpatrick, Category Manager, duly authorised
Section six. Complementary information
six.1) Information about recurrence
This is a recurrent procurement: No
six.2) Information about electronic workflows
Electronic ordering will be used
Electronic invoicing will be accepted
Electronic payment will be used
six.3) Additional information
All as detailed in attached tender documents.
NOTE: To register your interest in this notice and obtain any additional information please visit the Public Contracts Scotland Web Site at https://www.publiccontractsscotland.gov.uk/Search/Search_Switch.aspx?ID=697296.
The buyer has indicated that it will accept electronic responses to this notice via the Postbox facility. A user guide is available at https://www.publiccontractsscotland.gov.uk/sitehelp/help_guides.aspx.
Suppliers are advised to allow adequate time for uploading documents and to dispatch the electronic response well in advance of the closing time to avoid any last minute problems.
(SC Ref:697296)
Download the ESPD document here: https://www.publiccontractsscotland.gov.uk/ESPD/ESPD_Download.aspx?id=697296
six.4) Procedures for review
six.4.1) Review body
Dundee Sheriff Court
West Bell Street
Dundee City
Country
United Kingdom