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

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

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

	Purchase
	Rent
	Lease
	Hire-purchase
	Combination of these

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

UNITED KINGDOM.

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)

Pharmaceutical products, pharmaceutical articles, medical equipments, pharmaceuticals and personal care products, medical consumables, chemical products, specialised chemical products, nuclear, biological, chemical and radiological protection equipment,

the chemical biological radiological and nuclear protection delivery team is inviting expressions of interest in respect of a proposed contract for the development, process validation, manufacture and supply of physostigmine free base as an active pharmaceutical ingredient (API) for use in a Ministry of Defence (MOD) final medicinal product currently under development.

The supplier will be required to develop, scale-up and validate the manufacturing method, define a detailed specification and full characterisation of the API, Physostigmine (also known as eserine; chemical name 1,2,3,3aβ,8,8aβ-hexahydro-1,3a,8-trimethylpyrrolo[2,3-b] indol-5-yl-methylcarbamate; chemical formula C15H21N3O2; molecular weight 275,36 g/mol)

The supplier will be required to supply the authority with full information on the manufacture and control of the API as described in Annex I to Directive 2001/83/EC as amended (with particular reference to Part I, Section 3) and elaborated in the notice to applicants (Eudralex Volume 2: https://ec.europa.eu/health/documents/eudralex/vol-2_en).

The specification should meet modern standards and best endeavours should be taken to remove processing impurities. The specification should align with current regulatory requirements for active pharmaceutical ingredients (including Ph.Eur). The supplier will also be expected to analyse a sample (as much as is required) of the authority’s existing physostigmine API material, to assess the comparability of the 2 (to permit bridging between studies using old versus new material). The authority will review the comparability and determine whether the specification of the new API is acceptable.

The supplier will be required to conduct appropriate stability studies as often as required as per the international conference on harmonisation (standard and accelerated), forced degradation and provide data in the form of a written report (including protocol(s)) to support the shelf life to be applied. A shelf life of at least 3 years under storage conditions 2-8ºC is required.

The supplier will prepare a primary reference standard no later than the day of commencement of performance validation batches. This standard will be tested throughout its shelf life to maintain its usability and where necessary replaced with a new standard. This standard must be sufficient for all testing required throughout the life of the contract and the authority reserves the right to request quantities on an ad-hoc basis.

II.1.6)

Common Procurement Vocabulary (CPV)

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

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

This will be specified in the invitation to negotiate.

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 specified in the invitation to negotiate.

III.1.4)

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

This will be specified in the invitation to negotiate.

III.1.5)

Information about security clearance

III.2)

Conditions for Participation

III.2.1)

Personal situation

The authority will apply all the offences listed in Article 39(1) of Directive 2009/81/EC (implemented as Regulation 23(1) of the Defence and Security Public Contract Regulations (DSPCR) 2011 in the UK) and all of the professional misconducts listed at Article 39(2) of Directive 2009/81/EC (see also Regulation 23(2) in the DSPCR 2011) to the decision of whether a candidate is eligible to be invited to tender.

A full list of the Regulation 23(1) and 23(2) criteria are at http://www.contracts.mod.uk/delta/project/reasonsForExclusion.html#dspr

Candidates will be required to sign a declaration confirming whether they do or do not have any of the listed criteria as part of the pre-qualification process.

Candidates who have been convicted of any of the offences under Article 39(1) are ineligible and will not be selected to bid, unless there are overriding requirements in the general interest (including defence and security factors) for doing so.

Candidates who are guilty of any of the offences, circumstances or misconduct under Article 39(2) may be excluded from being selected to bid at the discretion of the authority.

III.2.2)

Economic and financial standing

III.2.3)

Technical and/or professional capacity

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

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

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/00265

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

IV.3.4)

Time-limit for requests to participate

IV.3.5)

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

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

VI.2)

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

VI.3)

Additional Information

The contracting authority considers that this contract may be suitable for economic operators that are small or medium enterprises (SMEs). However, any selection of tenderers will be based solely on the criteria set out for the procurement. The authority reserves the right to amend any condition related to security of information to reflect any changes in national law or government policy.

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 a security aspects letter, the authority reserves the right to amend the terms of the security aspects letter 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-GFVY72BG).

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 complete the pre-qualification questionnaire (PQQ) to 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) or above, if you score below 2 (Satisfactory) for question DCO 5.1 or 5.2 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.

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: 43W9T5S6SV.

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 tel. 0800 282 324.

Go reference: GO-20191115-DCB-15567326

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:

VI.4.3)

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

VI.5)

Dispatch date of this Notice