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

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)

The Ministry of Defence (MoD) is inviting expressions of interest for a requirement for the provision of Physostigmine Free Base(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). as part of an ongoing product development and anticipated commercialisation.

The initial Physostigmine supplied must be suitable for use in a pivotal Phase I clinical setting and the manufacturing process will produce material which does not add additional non-clinical activities to the overall programme, best endeavours should be taken to remove processing impurities.

The Supplier is to develop, scale-up and validate the manufacturing method for Physostigmine Free Base as an Active Pharmaceutical Ingredient (API) for use in a MoD final medicinal product currently under development.

The API must be developed and manufactured according to Good Manufacturing Practice (GMP) and must conform to European Transmissible Spongiform Encephalopathies (TSE) requirements, developed such that Intellectual property (IP) is vested in the Authority.

The Authority intends to seek a Marketing Authorisation for the final medicinal product from the Medicines and Healthcare products Regulatory Agency (MHRA) and Physostigmine will be required as an active ingredient for a future registered medicinal product.

The Supplier is required to provide information necessary for the Authority to complete the Chemistry, Manufacturing and Control (CMC) documentation to support a Clinical Trial Application (CTA) and Marketing Authorisation Application for the final medicinal product and make this documentation available to the MA applicant in an appropriate format for inclusion within CTD Module 3.

The Authority anticipates a Limited Quality by Design (QBD) approach to the manufacturing process as defined by the International Conference on Harmonisation (ICH).

All procurement documents are accessible via www.contracts.mod.uk

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

II.3)

Duration of the contract or limit for completion

Section III: Legal, Economic, Financial and Technical Information

III.1)

Conditions Relating to the Contract

III.1.1)

Deposits and guarantees required

To be specified in the Invitation to Negotiate

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

To be specified in the Invitation to Negotiate

III.1.4)

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

To be specified in the Invitation to Negotiate

III.1.5)

Information about security clearance

III.2)

Conditions for Participation

III.2.1)

Personal situation

Suppliers Instructions How to Express Interest in this Tender:

1. Register your company on the eSourcing portal (this is only required once)

- Browse to the eSourcing Portal

- Click the “Click here to register” link

- Accept the terms and conditions and click “continue”

- Enter your correct business and user details

- Note the username you chose and click “Save” when complete

- You will shortly receive an email with your unique password (please keep this secure)

2. Express an Interest in the tender

- Login to the portal with the username/password

- Click the "PQQs Open to All Suppliers" link. (These are Pre-Qualification Questionnaires open to any registered supplier)

- Click on the relevant PQQ to access the content.

- Click the “Express Interest” button in the “Actions” box on the left-hand side of the page.

- This will move the PQQ into your “My PQQs” page. (This is a secure area reserved for your projects only)

- Click on the PQQ code, you can now access any attachments by clicking the “Settings and Buyer Attachments” in the “Actions” box

3. Responding to the tender

- You can now choose to “Reply” or “Reject” (please give a reason if rejecting)

- You can now use the ‘Messages’ function to communicate with the buyer and seek any clarification

- Note the deadline for completion, then follow the onscreen instructions to complete the PQQ

- There may be a mixture of online & offline actions for you to perform (there is detailed online help available)

If you require any further assistance please consult the online help, or contact the eTendering help desk.

Suppliers Instructions How to Express Interest in this Tender:

1. Register your company on the eSourcing portal (this is only required once)

- Browse to the eSourcing Portal

- Click the “Click here to register” link

- Accept the terms and conditions and click “continue”

- Enter your correct business and user details

- Note the username you chose and click “Save” when complete

- You will shortly receive an email with your unique password (please keep this secure)

2. Express an Interest in the tender

- Login to the portal with the username/password

- Click the "PQQs Open to All Suppliers" link. (These are Pre-Qualification Questionnaires open to any registered supplier)

- Click on the relevant PQQ to access the content.

- Click the “Express Interest” button in the “Actions” box on the left-hand side of the page.

- This will move the PQQ into your “My PQQs” page. (This is a secure area reserved for your projects only)

- Click on the PQQ code, you can now access any attachments by clicking the “Settings and Buyer Attachments” in the “Actions” box

3. Responding to the tender

- You can now choose to “Reply” or “Reject” (please give a reason if rejecting)

- You can now use the ‘Messages’ function to communicate with the buyer and seek any clarification

- Note the deadline for completion, then follow the onscreen instructions to complete the PQQ

- There may be a mixture of online & offline actions for you to perform (there is detailed online help available)

If you require any further assistance please consult the online help, or contact the eTendering help desk.

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

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 intends to use an e-Tendering system in this procurement exercise, please visit www.contracts.mod.uk for full details and to register your interest in this procurement.

The Cyber Risk Profile for this requirement identified by the Cyber Risk Assessment is Very Low (Reference – RAR-800645056).

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