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Summary

OCID:
Published by:: Unknown
Authority ID:: AA47308
Publication date:: 03 June 2020
Deadline date:: -
Notice type:: Contract Notice
Has documents:: No
Has SPD:: No
Has Carbon Reduction Plan:: N/A

Abstract

Full notice text

CONTRACT NOTICE FOR CONTRACTS IN THE FIELD OF DEFENCE AND SECURITY

Section I: Contracting Authority

I.1)

Name, Address and Contact Point(s)

Official Name: Ministry of Defence, ISTAR, Chemical, Biological, Radiological and Nuclear Delivery Team (CBRN DT)
Postal Address: YEW 3a, #1342, MOD Abbey Wood
Town: Bristol	Postal Code: BS34 8JH	Country: UK
Contact Point: George Pritchard For the attention of:	Telephone: +44 3067933663
E-Mail: George.Pritchard112@mod.gov.uk	Fax:
General Address of the contracting authority (URL) https://www.gov.uk/government/organisations/defence-equipment-and-support Address of the Buyers Profile (URL) https://www.gov.uk/government/organisations/defence-equipment-and-support

Further information can be obtained at:	As in above mentioned contact point(s) Other: Please complete Annex A.I
Specifications and further documents can be obtained at:	As in above mentioned contact point(s) Other: Please complete Annex A.II
Tenders or requests to participate must be sent to:	As in above mentioned contact point(s) Other: Please complete Annex A.III

I.2)

Type of contracting Authority and Main Activity or Activities

	Ministry or any other national or federal authority, including their regional or local sub-divisions
	National or federal agency/Office
	Regional or local Authority
	Regional or local Agency/Office
	Body governed by public law
	European Institution/Agency or International Organisation

	General public services
	Defence
	Public order and safety
	Environment
	Economic and financial affairs
	Health
	Housing and community amenities
	Social protection
	Recreation, culture and religion
	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

Provision of an Auto-Injector Partner

II.1.2)

Type of supplies contract

	Purchase
	Rent
	Lease
	Hire-purchase
	Combination of these

Main site or location of works, place of delivery or performance

Gloucestershire, Wiltshire and Bristol/Bath area.

NUTS Code UKK1

II.1.3)

Information on framework agreement

The notice involves the establishment of a framework agreement

II.1.4)

Information on framework agreement (if applicable)

	Framework agreement with a single operators
	Framework agreement with several operators

Number of participants to the framework agreement envisaged

Duration of the framework agreement

Justification for a framework agreement the duration of which exceeds seven years

Estimated total value of purchases for the entire duration of the framework agreement

Frequency and value of the contracts to be awarded

II.1.5)

Short description of the contract or purchase(s)

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 (CPV)

	Main vocabulary	Supplementary vocabulary (when applicable)
Main object	35113200
Additional objects

85121200

33600000

33680000

33000000

33190000

33140000

24000000

24950000

33100000

33141320

II.1.7)

Information about subcontracting

	The tenderer has to indicate in the tender any share of the contract it may intend to subcontract to third parties and any proposed subcontractor, as well as the subject-matter of the subcontracts for which they are proposed.
	The tenderer has to indicate any change occurring at the level of subcontractors during the execution of the contract.
	The contracting authority/entity may oblige the successful tenderer to award all or certain subcontracts through the procedure set out in Title III of Directive 2009/81/EC.
	The successful tenderer is obliged to specify which part or parts of the contract it intends to subcontract beyond the required percentage and to indicate the subcontractors already identified.
	The successful tenderer is obliged to subcontract the following share of the contract through the procedure set out in Title III of Directive 2009/81/EC: minimum percentage: (%), maximum percentage: (%) of the value of the contract. (The maximum percentage may not exceed 30% of the value of the contract)

II.1.8)

Division into lots

II.1.9)

Will variants be accepted

Yes

II.2)

Quantity or Scope of the Contract

II.2.1)

Total quantity or scope

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 1.5 ml 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 3 ml, or 1.5 ml 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 5 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 ISO 13485:2016 (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 range between 20 000 000 and 100 000 000
Currency: GBP

II.2.2)

Information about options

Option period 1 — continued support from October 2023 to October 2035.

Provisional timetable for recourse to these options

144 months (from award of the contract)

II.2.3)

Information about renewals

Number of possible renewals:
In the case of renewable supplies or service contracts, estimated time frame for subsequent contracts:

Section III: Legal, Economic, Financial and Technical Information

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 Terms of financing and payment and/or reference to the relevant provisions

This will be detailed in the ITN.

III.1.3)

Legal form to be taken by the grouping of suppliers, contractors or service providers 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

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:

01-10-2035

III.2)

Conditions for Participation

III.2.1)

Personal situation

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 (if applicable)
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)
Information and formalities necessary for evaluating if the requirements are met:

(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.

This will be detailed in the ITN.

Minimum level(s) of standards possibly required:

This will be detailed in the ITN.

Criteria regarding the economic and financial standing of subcontractors (that may lead to their rejection) (if applicable)
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:

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:

This will be detailed in the ITN.

Criteria regarding the technical and/or professional ability of subcontractors (that may lead to their rejection) (if applicable)
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:

This will be detailed in the ITN.

III.2.4)

Reserved contracts

	The contract is restricted to sheltered workshops
	The execution of the contract is restricted to the framework of sheltered employment programmes

Section IV: Procedure

IV.1)

Type of Procedure

IV.1.1)

Type of Procedure

	Restricted
	Accelerated restricted
	Negotiated
	Accelerated negotiated
	Competitive dialogue

Justification for the choice of accelerated procedure

IV.1.2)

Limitations on the number of operators who will be invited to tender or to participate

Envisaged minimum number

Objective criteria for choosing the limited number of candidates

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

IV.2)

Award Criteria

A) Lowest Price No

B) The most economically advantageous tender in terms of:

B1) Criteria as stated in contract documents: Yes

B2) Criteria as stated below: No

Criteria

Weighting

IV.2.2)

An electronic auction will be used

IV.3 Administrative Information

IV.3.1)

Reference number attributed to the notice by the contracting authority

CBRN/AIP

IV.3.2)

Previous publication(s) concerning the same contract

	Prior Information Notice
	Notice on a Buyer Profile

Other previous publications

IV.3.3)

Conditions for obtaining specifications and additional documents

Obtainable until

Price (where applicable) Currency:

Terms and method of payment:

IV.3.4)

Time-limit for requests to participate

30-06-2020 12:00

IV.3.5)

Date of dispatch of invitations to tender or to participate to selected candidates

Estimated date 31-07-2020

IV.3.6)

Language or languages in which tenders or requests to participate can be drawn up

Section VI: Complimentary Information

VI.1)

Indicate whether this procurement is a recurrent one and the Estimated timing for further notices to be published

2033

VI.2)

Does the contract relate to a Project/Programme financed by Community Funds?

No

If yes, indicate the project/programme and any useful reference

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

() 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.

Go reference: GO-2020529-DCB-16647297

VI.4)

Procedures for appeal

VI.4.1)

Body responsible for appeal procedures

Official Name: Ministry of Defence, ISTAR, Chemical, Biological, Radiological and Nuclear Delivery Team (CBRN DT)
Postal Address:
Town: Bristol	Postal Code:	Country: UK
E-Mail: George.Pritchard112@mod.gov.uk	Telephone: +44 3067933663
Internet address (URL):	Fax:

Body responsible for mediation procedures

Official Name: Ministry of Defence, ISTAR, Chemical, Biological, Radiological and Nuclear Delivery Team (CBRN DT)
Postal Address:
Town: Bristol	Postal Code:	Country: UK
E-Mail: George.Pritchard112@mod.gov.uk	Telephone: +44 3067933663
Internet address (URL):	Fax:

VI.4.2)

Lodging of appeals
Precise information on deadline(s) for lodging appeals:

VI.4.3)

Service from which information about the lodging of appeals may be obtained

Official Name: Ministry of Defence, ISTAR, Chemical, Biological, Radiological and Nuclear Delivery Team (CBRN DT)
Postal Address:
Town: Bristol	Postal Code:	Country: UK
E-Mail: George.Pritchard112@mod.gov.uk	Telephone: +44 3067933663
Internet address (URL):	Fax:

VI.5)

Dispatch date of this Notice

29-05-2020

SF 37

Coding

Commodity categories

ID	Title	Parent category
24000000	Chemical products	Materials and Products
33140000	Medical consumables	Medical equipments
33100000	Medical equipments	Medical equipments, pharmaceuticals and personal care products
33000000	Medical equipments, pharmaceuticals and personal care products	Materials and Products
33141320	Medical needles	Disposable non-chemical medical consumables and haematological consumables
85121200	Medical specialist services	Medical practice services
33190000	Miscellaneous medical devices and products	Medical equipments
35113200	Nuclear, biological, chemical and radiological protection equipment	Safety equipment
33680000	Pharmaceutical articles	Pharmaceutical products
33600000	Pharmaceutical products	Medical equipments, pharmaceuticals and personal care products
24950000	Specialised chemical products	Fine and various chemical products

Delivery locations

ID	Description
100	UK - All

Alert region restrictions

The buyer has restricted the alert for this notice to suppliers based in the following regions.

ID	Description
There are no alert restrictions for this notice.

About the buyer

Main contact:: N/a
Admin contact:: N/a
Technical contact:: N/a
Other contact:: N/a

Further information

Date	Details
No further information has been uploaded.

Provision of an Auto-Injector Partner

Contents

Summary

Abstract

Full notice text

CONTRACT NOTICE FOR CONTRACTS IN THE FIELD OF DEFENCE AND SECURITY

Section I: Contracting Authority

I.1)

Name, Address and Contact Point(s)

I.2)

Type of contracting Authority and Main Activity or Activities

Section II: Object of the Contract

II.1)

Description

II.1.1)

Title attributed to the contract by the contracting authority

II.1.2)

Type of supplies contract

Main site or location of works, place of delivery or performance

II.1.3)

Information on framework agreement

II.1.4)

Information on framework agreement (if applicable)

Number of participants to the framework agreement envisaged

Duration of the framework agreement

Justification for a framework agreement the duration of which exceeds seven years

Estimated total value of purchases for the entire duration of the framework agreement

Frequency and value of the contracts to be awarded

II.1.5)

Short description of the contract or purchase(s)

II.1.6)

Common Procurement Vocabulary (CPV)

II.1.7)

Information about subcontracting

II.1.8)

Division into lots

II.1.9)

Will variants be accepted

II.2)

Quantity or Scope of the Contract

II.2.1)

Total quantity or scope

II.2.2)

Information about options

Provisional timetable for recourse to these options

II.2.3)

Information about renewals

Section III: Legal, Economic, Financial and Technical Information

III.1)

Conditions Relating to the Contract

III.1.1)

Deposits and guarantees required

III.1.2)

Main Terms of financing and payment and/or reference to the relevant provisions

III.1.3)

Legal form to be taken by the grouping of suppliers, contractors or service providers to whom the contract is to be awarded

III.1.4)

Other particular conditions to which the performance of the contract is subject

III.1.5)

Information about security clearance

III.2)

Conditions for Participation

III.2.1)

Personal situation

III.2.2)

Economic and financial standing

III.2.3)

Technical and/or professional capacity

III.2.4)

Reserved contracts

Section IV: Procedure

IV.1)

Type of Procedure

IV.1.1)

Type of Procedure

Justification for the choice of accelerated procedure

IV.1.2)

Limitations on the number of operators who will be invited to tender or to participate

Objective criteria for choosing the limited number of candidates

IV.1.3)

Lodging of appeals
Precise information on deadline(s) for lodging appeals: