UK-Bristol: Nuclear, Biological, Chemical and Radiological protection equipment. (Defence)

Closed 14 days ago

DEFENCE CONTRACTS INTERNATIONAL/ MINISTRY OF DEFENCE
Value
100m GBP
Date published
Closed 43 days ago
Deadline
Closed 14 days ago
Categories
- None

Country
United Kingdom

OCID
ocds-0c46vo-0120-2331138982
Description

Type of document:

Contract Notice
Country
:

United Kingdom
UK-Bristol:

Nuclear, Biological, Chemical and Radiological protection equipment.


I.1)Name, Addresses and Contact Point(s):
Ministry of Defence, ISTAR, Chemical, Biological, Radiological and Nuclear Delivery Team (CBRN DT)
YEW 3a, #1342, MOD Abbey Wood, Bristol, BS34 8JH, United Kingdom
Tel. +44 03067933663, Email:
George.Pritchard112@mod.gov.uk
Contact:

George Pritchard
Main Address:

https://www.gov.uk/government/organisations/defence-equipment-and-support, Address of the buyer profile:
https://www.gov.uk/government/organisations/defence-equipment-and-support
NUTS Code:

UKK1
Further information can be obtained at:

As Above
Specifications and additional documents:

As Above
Applications must be sent to:

As Above

I.2)Type of the contracting authority and main activity or activities:
Ministry or any other national or federal authority, including their regional or local subdivisions

I.3) Main activity:
Defence

I.4) Contract award on behalf of other contracting authorities/entity:
The contracting authority is purchasing on behalf of other contracting authorities:

No


II.1)Description

II.1.1)Title attributed to the contract by the contracting authority/entity:
Provision of an Auto-Injector Partner

II.1.2)Type of contract and location of works, place of delivery or of performance:
SUPPLIES
Purchase
Region Codes:

UKK1 - Gloucestershire, Wiltshire and Bristol/Bath area

II.1.3)Framework agreements:
Not Provided

II.1.5)Short description of the contract or purchase:
Nuclear, Biological, Chemical and Radiological protection equipment. Medical specialist services. Pharmaceutical products. Pharmaceutical articles. Medical equipments, pharmaceuticals and personal care products. Miscellaneous medical devices and products. Medical consumables. Chemical products. Specialised chemical products. Medical equipments. Medical needles. The UK Ministry of Defence (UK MOD) has an identified and likely future requirement for the production of single and triple therapy auto-injector devices for intramuscular administration. The auto-injectors should be capable of storing up to three Active pharmaceuticals ingredients in a single, dual or triple chambered device. Full operating capability will require the final drug product to be submitted to Regulatory Agencies in the EU and the United Kingdom with the intent for full licensure / marketing authorisation (MA). The Chemical Biological Radiological Nuclear Team (CBRN) is therefore seeking to appoint a partner to manufacture current Auto-injector requirements with future options to manufacture other similar devices as they arise throughout the contractual period.

II.1.6)Common Procurement Vocabulary:
35113200 - Nuclear, Biological, Chemical and Radiological protection equipment.
85121200 - Medical specialist services.
33600000 - Pharmaceutical products.
33680000 - Pharmaceutical articles.
33000000 - Medical equipments, pharmaceuticals and personal care products.
33190000 - Miscellaneous medical devices and products.
33140000 - Medical consumables.
24000000 - Chemical products.
24950000 - Specialised chemical products.
33100000 - Medical equipments.
33141320 - Medical needles.

II.1.7)Information about subcontracting:

Not Provided

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 (including all lots, renewals and options):
The Supplier will be responsible for:

1.
Demonstrating of wet or wet/dry storage capability in an existing auto-injector. The maximum capacities of chamber will be no more than 3 ml or 1.5ml per chamber if dual chamber.
2.
Protocols for, and results of, forced degradation studies of Midazolam, atropine and 2PAM, using previously validated analytical methods demonstrated to qualify and quantify known degradants of each API.
3.
Documentation of the processes and validated test methods describing the manufacturing and performance of the active auto-injector / drug product.
4.
Demonstration of stability of active auto-injectors, and of the active pharmaceutical ingredients stored within the active auto-injector.
5.
Demonstration of wet storage capability in an auto-injector i.e. within the cartridge or the device. The maximum capacities of the chamber will be no more than 3ml, or 1.5ml if dual chamber (and sufficient if dual chamber for separated API.
6.
Demonstration of technical and performance (including safety). Testing described in ISO 11608 and the quality systems of ISO13485 and the requirements of the Medical Devices Regulations (MDR) should be considered. Distribution robustness should be modelled and tested to ensure the product remains intact under operational transport stresses.
7.
Demonstration of robustness (stress testing) of the tertiary packaging of the assembled auto-injector in its proposed tertiary packaging, and suitability of the packaging for military use.
8.
Provision of the Specification documentation for the active auto-injector device, the APIs and the processes and test methods describing the manufacturing and performance of the active auto-injector device.
9.
Demonstration of the consistency of manufacturing of the active auto-injector device through process validation activities according to ICH Q8 R2 Part 1.
10.
Provision of Training auto-injector devices and instructions for use.
11.
Protocols for, and results (in interim and final Reports) of ICH and GxP-compliant stability studies. Stability studies for up to five years.
12.
Certification of the auto-injector to CE standard, meeting the requirements of the Medical Device Regulation 2017/745, as amended, and manufactured to ISO13485:2016 (or current version).
13.
Documentation and data review to populate a Common Technical Document prior to Marketing Authorisation Application, including a Paediatric Investigation Plan waiver.
14.
Manufacture product in accordance with current Good Manufacturing Practice (cGMP) standards as defined by the International Conference on Harmonisation and regulated by the national competent Authority’s in Europe and Canada.
15.
Storage of the finished product and all product movement between Qualified Person (QP) release and receipt will be carried out in accordance with the requirements of Good Distribution Practice (GDP) and the Guidelines on GDP on Medicinal Products for Human Use (2013/C 343/01) or as subsequently amended.
Estimated value excluding VAT:

Range between:

20,000,000 and 100,000,000
Currency:

GBP

II.2.2)Options:
Yes
If yes, description of these options: Option Period One - Continued support from October 2023 to October 2035
If known, Provisional timetable for recourse to these options:
Duration in months:

144 (from the award of the contract)

II.2.3)Renewals:
Yes

II.3)Duration Of The Contract Or Time-Limit For Completion


III.1)Conditions relating to the contract

III.1.1)Deposits and guarantees required:
This will be detailed in the ITN.

III.1.2)Main financing conditions and payment arrangements and/or reference to the relevant provisions governing them:
This will be detailed in the ITN.

III.1.3)Legal form to be taken by the group of economic operators to whom the contract is to be awarded:
This will be detailed in the ITN.

III.1.4) Other particular conditions to which the performance of the contract is subject, in particular with regard to security of supply and security of information:

This will be detailed in the ITN.

III.1.5) Information about security clearance
Candidates which do not yet hold security clearance may obtain such clearance until:

2035-10-01 00:00:00.0

III.2)Conditions For Participation

III.2.1)Economic and financial capacity:

Criteria regarding the personal situation of economic operators (that may lead to their exclusion) including requirements relating to enrolment on professional or trade registers.
Information and formalities necessary for evaluating if the requirements are met:

This will be detailed in the ITN.
Criteria regarding the personal situation of subcontractors (that may lead to their rejection) including requirements relating to enrolment on professional or trade registers
Information and formalities necessary for evaluating if the requirements are met:

This will be detailed in the ITN.

III.2.2) Economic and financial standing:

Criteria regarding the economic and financial standing of economic operators (that may lead to their exclusion)
(c)
where appropriate, a statement, covering the three previous financial years of the economic operator, of:(i) the overall turnover of the business of the economic operator; and (ii) where appropriate, the turnover in respect of the work, works, goods or services which are of a similar type to the subject matter of the contract.
Information and formalities necessary for evaluating if the requirements are met:

This will be detailed in the ITN.
Minimum level(s) of standards possibly required:

(if applicable)
This will be detailed in the ITN.
Criteria regarding the economic and financial standing of subcontractors (that may lead to their rejection)
Information and formalities necessary for evaluating if the requirements are met:

This will be detailed in the ITN.
Minimum level(s) of standards possibly required:

(if applicable)
This will be detailed in the ITN.

III.2.3) Technical and/or professional capacity:

Criteria regarding the technical and/or professional ability of economic operators (that may lead to their exclusion)
Information and formalities necessary for evaluating if the requirements are met:

This will be detailed in the ITN.
Minimum level(s) of standards possibly required:

(if applicable)
This will be detailed in the ITN.
Criteria regarding the technical and/or professional ability of subcontractors (that may lead to their rejection)
Information and formalities necessary for evaluating if the requirements are met:

This will be detailed in the ITN.
Minimum level(s) of standards possibly required:

(if applicable)
This will be detailed in the ITN.

III.2.4) Information about reserved contracts:
Not Provided


IV.1)Type Of Procedure

IV.1.1)Type of procedure:
Negotiated

IV.1.2)Limitations on the number of operators who will be invited to tender or to participate:
Not Provided

IV.1.3)Reduction of the number of operators during the negotiation or dialogue:
Not Provided

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:
CBRN/AIP

IV.3.2)Previous publication(s) concerning the same contract:
No

IV.3.3)Conditions for obtaining specifications and additional documents or descriptive document:
Not Provided

IV.3.4)Time-limit for receipt of tenders or requests to participate
Date:

30/06/2020
Time:

12:00

IV.3.5)Date of dispatch of invitations to tender or to participate to selected candidates:
31/07/2020

IV.3.6)Language(s) in which tenders or requests to participate may be drawn up:
English


VI.1)This Is A Recurrent Procurement:
Yes
Estimated timing for further notices to be published:

2033

VI.2)The contract is related to a project and/or programme financed by European Union funds:
No

VI.3)Additional Information:
The Authority reserves the right to amend any condition related to security of information to reflect any changes in national law or government policy. If any contract documents are accompanied by instructions on safeguarding classified information (e.g. a Security Aspects Letter), the Authority reserves the right to amend the terms of these instructions to reflect any changes in national law or government policy, whether in respect of the applicable protective marking scheme, specific protective markings given, the aspects to which any protective marking applies, or otherwise. The link below to the Gov.uk website provides information on the Government Security Classification.
https://www.gov.uk/government/publications/government-security-classifications
Advertising Regime OJEU:

- This contract opportunity is published in the Official Journal of the European Union (OJEU),the MoD Defence Contracts Bulletin and www.contracts.mod.uk
The Cyber Risk Profile for this requirement identified by the Cyber Risk Assessment is Very low (Ref No:

RAR-UMXB85VX).
Electronic Trading
Potential suppliers must note the mandatory requirement for electronic trading using the Contracting, Purchasing and Finance (CP&F) electronic procurement tool. All payments for Contractor Deliverable's under the Contract shall only be made via CP&F. You can find details on CP&F at https://www.gov.uk/government/publications/mod-contracting-purchasing-and-finance-e-procurement-system.
Interested suppliers are required to fully complete the Pre-Qualification Questionnaire (PQQ) to answer all questions and provide the Authority with information to evaluate the supplier’s capacity and capability against the selection criteria.
The Authority will use the PQQ response to create a shortlist of tenderers who:


(1)
are eligible to participate;
(2)
fulfil any minimum economic, financial, professional and technical standards; and
(3)
best meet in terms of capacity and capability the selection criteria set out in the PQQ.
Full details of the method for choosing the tenderers will be set out in the PQQ. For all scored questions Potential Suppliers must achieve a mark of 2 (Satisfactory), if you score below 2 (Satisfactory) the Authority reserves the right to eliminate you from the competition.
During the PQQ stage, the intention is to arrive at a short list of a minimum of three (3) and a maximum of six (6) qualified potential suppliers for formal invitation to negotiate.
This list of six (6) qualified potential suppliers will be made up of the top six (6) performing PQQ responses.
Suppliers must read through this set of instructions and follow the process to respond to this opportunity.
The information and/or documents for this opportunity are available on http://www.contracts.mod.uk.
Suppliers must read through this set of instructions and follow the process to respond to this opportunity.
The information and/or documents for this opportunity are available on http://www.contracts.mod.uk.
You must register on this site to respond, if you are already registered you will not need to register again, simply use your existing username and password. Please note there is a password reminder link on the homepage.
Suppliers must log in, go to your Response Manager and add the following Access Code: FK85P6K285.
Please ensure you follow any instruction provided to you here.
The deadline for submitting your response(s) is detailed within this contract notice, you will also have visibility of the deadline date, once you have added the Access code via DCO as the opening and closing date is visible within the opportunity.
Please ensure that you allow yourself plenty of time when responding to this opportunity prior to the closing date and time, especially if you have been asked to upload documents.
If you experience any difficulties please refer to the online Frequently Asked Questions (FAQ’s) or the User Guides or contact the MOD DCO Helpdesk by emailing
support@contracts.mod.uk
or Telephone 0800 282 324.

VI.4)Procedures For Appeal

VI.4.1)Body responsible for appeal procedures:
Ministry of Defence, ISTAR, Chemical, Biological, Radiological and Nuclear Delivery Team (CBRN DT)
Bristol, United Kingdom
Tel. +44 3067933663, Email:
George.Pritchard112@mod.gov.uk
Body responsible for mediation procedures:


Ministry of Defence, ISTAR, Chemical, Biological, Radiological and Nuclear Delivery Team (CBRN DT)
Bristol, United Kingdom
Tel. +44 3067933663, Email:
George.Pritchard112@mod.gov.uk

VI.4.2)Procedures for appeal:
Not Provided

VI.4.3)Service from which information about the lodging of appeals may be obtained:
Ministry of Defence, ISTAR, Chemical, Biological, Radiological and Nuclear Delivery Team (CBRN DT)
Bristol, United Kingdom
Tel. +44 3067933663, Email:
George.Pritchard112@mod.gov.uk

VI.5) Date Of Dispatch Of This Notice:
29/05/2020

ANNEX A