Manufacture of HI-6 dimethylsulphonate

On behalf of the Department of National Defence of Canada, the Minister of Defence of the Kingdom of the Netherlands and the Secretary of State for Defence of the United Kingdom of Great Britain and Northern Ireland, Dstl has a requirement to license a drug product containing the substance HI-6 dimethanesulfonate (HI-6 DMS).

UK-Salisbury: pharmaceutical products

2012/S 149-249131

Contract notice

Supplies

Directive 2004/18/EC

Section I: Contracting authority

I.1)Name, addresses and contact point(s)

DSTL
Bldg 5, G02-D, Porton Down
Contact point(s): B S Morris
SP4 0JQ Salisbury
UNITED KINGDOM
Telephone: +44 1980616067
E-mail: bsmorris@dstl.gov.uk

Further information can be obtained from: The above mentioned contact point(s)

Specifications and additional documents (including documents for competitive dialogue and a dynamic purchasing system) can be obtained from: The above mentioned contact point(s)

Tenders or requests to participate must be sent to: The above mentioned contact point(s)

I.2)Type of the contracting authority

Ministry or any other national or federal authority, including their regional or local sub-divisions

I.3)Main activity

Defence

I.4)Contract award on behalf of other contracting authorities

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:

Production / Manufacture of HI-6 dimethylsulphonate (HI-6 DMS).

II.1.2)Type of contract and location of works, place of delivery or of performance

Supplies
Purchase
NUTS code UKK1

II.1.3)Information about a public contract, a framework agreement or a dynamic purchasing system (DPS)

II.1.4)Information on framework agreement

II.1.5)Short description of the contract or purchase(s)

Pharmaceutical products. On behalf of the Department of National Defence of Canada, the Minister of Defence of the Kingdom of the Netherlands and the Secretary of State for Defence of the United Kingdom of Great Britain and Northern Ireland, Dstl has a requirement to license a drug product containing the substance HI-6 dimethanesulfonate (HI-6 DMS). The requirement of this work package is to produce HI-6 DMS for clinical use according to European Rules and Guidance for Good Manufacturing Practice (GMP).

II.1.6)Common procurement vocabulary (CPV)

33600000

II.1.7)Information about Government Procurement Agreement (GPA)

The contract is covered by the Government Procurement Agreement (GPA): no

II.1.8)Lots

This contract is divided into lots: no

II.1.9)Information about variants

Variants will be accepted: no

II.2)Quantity or scope of the contract

II.2.1)Total quantity or scope:

A manufacturing process for the production of HI-6 DMS with a Bis(methylsulfonoxymethyl) ether precursor has previously been developed and the details will be provided as Government Furnished Information (GFI) in the Invitation-To-Tender (ITT) documentation for vendors without prior experience or an established process for HI-6 DMS.
The requirements include:
— Technology Transfer of the manufacturing process (if applicable); Batch Manufacturing Records and analytical protocols will be made available by Dstl,
— Demonstration of the manufacturing process at the 3kg scale,
— Validation of analytical assays, equipment, shipping and storage,
— Validation of the manufacturing process at the 3kg scale,
— Manufacture of three consistency batches,
— Characterisation of the drug substance,
— Storage of bulk drug substance and filling of vials with sterilisation by gamma irradiation (or alternative),
— ‘Qualified Person’ release of bulk drug substance and of filled vials for use within Europe,
— Stability testing of the drug substance,
— Development of a Drug Master File / Certificate of Suitability for HI-6 DMS in support of Marketing Authorisations.

II.2.2)Information about options

II.2.3)Information about renewals

II.3)Duration of the contract or time 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:

III.1.2)Main financing conditions and payment arrangements and/or reference to the relevant provisions governing them:

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

III.1.4)Other particular conditions

The performance of the contract is subject to particular conditions: yes
Description of particular conditions: The drug substance must be manufactured in accordance with Good Manufacturing Practice (GMP).

III.2)Conditions for participation

III.2.1)Personal situation of economic operators, including requirements relating to enrolment on professional or trade registers

Information and formalities necessary for evaluating if the requirements are met: The Authority will apply all the offences listed in Article 45(1) of Directive 2004/18/EC (implemented as Regulation 23(1) of the Public Contract Regulations (PCR) 2006 in the UK) and all of the professional misconducts listed at Article 45(2) of Directive 2004/18/EC (see also Regulation 23(2) in the PCR 2006) 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. For candidates who are registered overseas, you will need to declare if you have any offences/misconduct under your own countries laws, where these laws are equivalent to the Regulation 23 lists.
Candidates who have been convicted of any of the offences under Article 45(1) are ineligible and will not be selected to bid, unless there are overriding requirements in the general interest for doing so.
Candidates who are guilty of any of the offences, circumstances or misconduct under Article 45(2) may be excluded from being selected to bid at the discretion of the Authority.

III.2.2)Economic and financial ability

Information and formalities necessary for evaluating if the requirements are met: (a) Appropriate statements from banks or, where appropriate, evidence of relevant professional risk indemnity insurance

III.2.3)Technical capacity

Information and formalities necessary for evaluating if the requirements are met:
(a) a list of the works carried out over the past five years, accompanied by certificates of satisfactory execution for the most important works. These certificates shall indicate the value, date and site of the works and shall specify whether they were carried out according to the rules of the trade and properly completed. Where appropriate, the competent authority shall submit these certificates to the contracting authority direct
(d) A description of the technical facilities and measures used by the supplier or service provider for ensuring quality and the undertaking’s study and research facilities
(e) Where the products or services to be supplied are complex or, exceptionally, are required for a special purpose, a check carried out by the contracting authorities or on their behalf by a competent official body of the country in which the supplier or service provider is established, subject to that body’s agreement, on the production capacities of the supplier or the technical capacity of the service provider and, if necessary, on the means of study and research which are available to it and the quality control measures it will operate
(i) A statement of the tools, plant or technical equipment available to the service provider or contractor for carrying out the contract
(j) An indication of the proportion of the contract which the services provider intends possibly to subcontract
(k) With regard to the products to be supplied: (i) samples, descriptions and/or photographs, the authenticity of which must be certified if the contracting authority so requests; (ii) certificates drawn up by official quality control institutes or agencies of recognised competence attesting the conformity of products clearly identified by references to specifications or standards

III.2.4)Information about reserved contracts

III.3)Conditions specific to services contracts

III.3.1)Information about a particular profession

III.3.2)Staff responsible for the execution of the service

Section IV: Procedure

IV.1)Type of procedure

IV.1.1)Type of procedure

Restricted

IV.1.2)Limitations on the number of operators who will be invited to tender or to participate

Envisaged minimum number 2
Objective criteria for choosing the limited number of candidates: Those suppliers Expressing an Interest will be invited to submit a PQQ. Suppliers returning a properly completed and compliant PQQ by the Due Date and demonstrating the required technical capabilities and good financial standing as requied by the PQQ will be further invited to submit a costed proposal.

IV.1.3)Reduction of the number of operators during the negotiation or dialogue

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)Information about electronic auction

An electronic auction will be used: no

IV.3)Administrative information

IV.3.1)File reference number attributed by the contracting authority:

DSTLX-1000065854

IV.3.2)Previous publication(s) concerning the same contract

Prior information notice

Notice number in the OJEU: 2012/S 60-097502 of 22.3.2012

IV.3.3)Conditions for obtaining specifications and additional documents or descriptive document

Payable documents: no

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

10.9.2012 – 17:00

IV.3.5)Date of dispatch of invitations to tender or to participate to selected candidates

1.10.2012

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

English.

IV.3.7)Minimum time frame during which the tenderer must maintain the tender

IV.3.8)Conditions for opening tenders

Section VI: Complementary information

VI.1)Information about recurrence

This is a recurrent procurement: no

VI.2)Information about European Union funds

The contract is related to a project and/or programme financed by European Union funds: no

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,and the contract will be awarded on the basis of the most economically advantageous tender.Suppliers interested in working with the Ministry of Defence should register on the MOD Supplier Information Database (SID) Register, available at www.contracts.mod.uk. The MOD SID is a database of active and potential suppliers available to all MOD and UK Defence procurement personnel, and is the main supplier database of MOD Procurement organisations. Please note: the registration and publication of a company profile on the MOD SID does not mean or imply that the supplier has in any way been vetted or approved by the MOD. Suppliers wishing to compete for advertised MOD contracts must respond to any specific call for competition by submitting a separate expression of interest in accordance with the instructions of the purchasing organisation.

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 GO Reference: GO-201281-DCB-4122957.

VI.4)Procedures for appeal

VI.4.1)Body responsible for appeal procedures

DSTL
G02-D, Bldg 5, Porton Down
SP4 0JQ Salisbury
UNITED KINGDOM

Body responsible for mediation procedures

DSTL

VI.4.2)Lodging of appeals

VI.4.3)Service from which information about the lodging of appeals may be obtained

DSTL
G02-D, Bldg 5, Porton Down
SP4 0JQ Salisbury
UNITED KINGDOM
E-mail: ksarkar@dstl.gov.uk
Telephone: +44 1980616348

VI.5)Date of dispatch of this notice:1.8.2012

Manufacture of HI-6 dimethylsulphonate