Defence Online

Type of document: Invitation to tender
Country: United Kingdom
OJEU Ref: (2016/S 175-315475/EN)
Nature of contract: Service contract
Procedure: Negotiated procedure
Regulation of procurement: EU
Type of bid required: Global bid

Contract notice
Services
Directive 2009/81/EC
Section I: Contracting authority
I.1) Name addresses and contact point(s):
Ministry of Defence, ISTAR, Chemical, Biological, Radiological and Nuclear Delivery Team (CBRN DT)
Yew 3a, #1342, NH1, MoD, Abbey Wood
Bristol
Postal code: BS34 8JH
United Kingdom
For the attention of: Miles Collinson, Michael Morgan
Phone: +44 3067985447
Email: DESCBRN-Comrcl-CP3@mod.uk
Internet Address(es):
General address of the contracting authority:
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/entities:
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/entity: CBRN/00216 Ethic.
II.1.2) Type of contract and location of works, place of delivery or of performance:
Services
Service category No 14: Building-cleaning services and property management services
Main site or location of works, place of delivery or of performance: Bristol, City of.
Nuts code: UKK11
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 specific contract:Medical equipments, pharmaceuticals and personal care products. Contract for the development and initial supply of a wet/dry auto-injector device. Demonstration of a wet/dry capability in a prototype or existing auto-injector that will be subject to user assessments in collaboration with the authority including user safety demonstration of device before and after use.
II.1.6) Common procurement vocabulary (CPV): 33000000,
II.1.7) Information about Government Procurement Agreement (GPA):
The contract is covered by the Government Procurement Agreement (GPA):
II.1.8) Lots:
The 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:
The CBRN Delivery Team has a requirement for the design, development, manufacture and testing of a prototype wet / dry, auto-injector. This prototype auto-injector shall successfully deliver a combination of a dry powder (Active Pharmaceutical Ingredient (API)) and an aqueous, citrate buffered solution containing 2 further APIs, for emergency use. This combination will be referred to as the ‘triple therapy’.
The Authority envisage a degree of design and development that may or may not, be based upon existing auto-injector designs, in order to successfully meet this requirement. Therefore, proposed solutions will be subject to Preliminary and Critical Design Reviews with the Authority. Furthermore, the agreed design shall be subject to performance and stability testing in accordance with the auto-injector specification that will be provided as part of the Invitation to Negotiate (ITN) issued to pre-qualified companies.
3 variants (Active, Placebo and Training devices) of the prototype device (and supporting documentation/studies) will be required as follows:
— An Active device defined as a pre-filled auto-injector that is labelled and ready for use and contains the ‘triple therapy’;
— A Placebo device defined as an auto-injector, equivalent in all respects to the Active auto-injector device, with the exception that it does not contain any of the 3 API;
— A Training device defined as an auto-injector, equivalent in all respects to the active and placebo auto-injector devices with the following exceptions:
(i) It does not contain any wet or dry ingredients;
(ii) It does not contain a needle;
(iii) It includes a mechanism that enables the Training auto-injector device to be re-set, to allow priming, activation and firing steps to be carried out repeatedly.
The Active and Placebo prototype devices shall be suitable for use in clinical trials and accordingly, the Authority expect the following milestones to be achieved during the course of the contract:
(i) That the wet/dry auto-injector will have been thoroughly tested and validated to enable execution of a safety and pharmacokinetic clinical trial with active drug substances:
(ii) That the active auto-injector device will have been tested and demonstrated as suitable for military use;
(iii) That the Contractor supports the Authority in submission of a Marketing Authorisation Application dossier;
(iv) That following Regulatory review, any relevant responses will have been provided against Competent Authority remarks and any deficiencies identified in Competent Authority reviews will have been resolved;
(v) That the final agreed prototype auto-injector will have received a Marketing Authorisation in the UK.
The devices containing active API prototype will have an option to carry out a 5 year stability study. The contract will therefore include an option to undertake this work.
Estimated value excluding VAT:
Range: between 1 000 000 and 2 500 000 GBP
II.2.2) Information about options:
Options: yes
The devices containing active API prototype will have an option to carry out a 5 year stability study. The contract will therefore include an option to undertake this work.
Provisional timetable for recourse to these options: in months: (from the award of the contract): 96
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:
The Authority reserves the right to request an indemnity if the supplier does not meet the required standard for economic and financial standing.
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:
If a group of economic operators submit a bid, the group must nominate a lead organisation to deal with the Authority. The Authority shall require the group to form a legal entity before entering into the contract.
III.1.4) Other particular conditions
The performance of the contract is subject to particular conditions: yes
Description of particular conditions: 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.
III.2) Conditions for participation
III.2.1) Personal situation of economic operators, including requirements relating to enrolment on professional or trade registers
The Authority will apply all the offences listed in Article 39(1) of Directive 2009/81/EC of the European Parliament and of the Council (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 of the European Parliament and of the Council (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: 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 ability
(b) The presentation of balance-sheets or extracts from the balance-sheets, where publication of the balance-sheet is required under the law of the country in which the economic operator is established;(c) Where appropriate, a statement, covering the 3 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.At least 2 years audited accounts (if available) or equivalent must be submitted as part of the Pre-Qualification Questionnaire response. The Authority reserves the right to request further financial information following receipt of the Pre-Qualification Questionnaire response.
Minimum level(s) of standards possibly required: (b) The presentation of balance-sheets or extracts from the balance-sheets, where publication of the balance-sheet is required under the law of the country in which the economic operator is established;(c) Where appropriate, a statement, covering the 3 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.At least 2 years audited accounts (if available) or equivalent must be submitted as part of the Pre-Qualification Questionnaire response. The Authority reserves the right to request further financial information following receipt of the Pre-Qualification Questionnaire response.Financial assessment will be undertaken on the supplier’s financial status. An overall pass / fail judgement will be made after considering areas such as turnover, profit, net assets, liquidity, gearing and capacity. This assessment will include the Parent company where applicable. An independent financial assessment obtained from a reputable credit rating organisation may be utilised as part of this process.
III.2.3) Technical capacity
Information and formalities necessary for evaluating if the requirements are met: (a) In the case of a supply contract requiring the siting or installation of goods, a services contract or a works contract, the economic operator’s technical ability, taking into account in particular that economic operator’s skills, efficiency, experience and reliability;(b) A list of works carried out over the past 5 years together with (unless the contracting authority specifies that the following certificate should be submitted direct to the contracting authority by the person certifying) certificates of satisfactory completion for the most important of those works indicating in each case: (i) the value of the consideration received; (ii) when and where the work or works were carried out; and (iii) specifying whether they were carried out according to the rules of the trade or profession and properly completed;(c) A statement of the principal goods sold or services provided by the supplier or the services provider in the past 5 years, or during a shorter period if necessary, and: (i) the dates on which the goods were sold or the services provided; (ii) the consideration received; (iii) the identity of the person to whom the goods were sold or the service were provided; (iv) any certificate issued or countersigned by that person confirming the details of the contract for those goods sold or services provided; and (v) where — (a) that person was not a contracting authority, and (b) the certificate referred to in sub-paragraph (c)(iv) is not available, any declaration by the economic operator attesting the details of the goods sold or services provided;(d) A statement of the technicians or technical services available to the economic operator to: (i) carry out the work under the contract, or (ii) be involved in the production of goods or the provision of services under the contract, particularly those responsible for quality control, whether or not they are independent of the economic operator;(e) A statement of the economic operator’s: (i) technical facilities; (ii) measures for ensuring quality; (iii) study and research facilities; and (iv) internal rules regarding intellectual property;(f) A check carried out by the contracting authority or on its behalf by a competent official body of the member State in which the economic operator is established: (i) on the technical capacity of the economic operator; and (ii) if relevant, on the economic operator’s study and research facilities and quality control measures;(g) In the case of works contracts, services contracts or supply contracts also covering siting and installation operations or services, the economic operator’s educational and professional qualifications where the economic operator is an individual and: (i) if any, those of the economic operator’s managerial staff; and (ii) those of 1 or more persons who would be responsible for providing the services or carrying out the work or works under the contract;(j) A description of the tools, material, technical equipment, staff numbers, know-how and sources of supply (with an indication of their geographical location when it is outside the territory of the EU) available to the economic operator to perform the contract, cope with any additional needs required by the contracting authority as a result of a crisis or carry out the maintenance, modernisation or adaptation of the goods covered by the contract;(k) Any samples, descriptions and photographs of the goods to be purchased or hired under the contract and certification of the authenticity of such samples, descriptions or photographs;(l) Certification by official quality control institutes or agencies of recognised competence, attesting that the goods to be purchased or hired under the contract conform to standards and technical specifications (within the meaning of regulation 12(1)) identified by the contracting authority;(n) A certificate: (i) attesting conformity to quality management systems standards based on the relevant European standard; and (ii) from an independent accredited body established in any member State conforming to the European standards concerning accreditation and certification.As requested at the: a) Pre-Qualification Questionnaire Stage; and b) The Invitation to Negotiate (ITN) stage for those companies down-selected to participate in the ITT stage.
Minimum level(s) of standards possibly required:
III.2.4) Information about reserved contracts
III.3) Conditions specific to services contracts
III.3.1) Information about a particular profession
Execution of the service is reserved to a particular profession:
III.3.2) Staff responsible for the execution of the service
Legal persons should indicate the names and professional qualifications of the staff responsible for the execution of the service: YES
Section IV: Procedure
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
Envisaged minimum number: 3 and maximum number 6
Objective criteria for choosing the limited number of candidates:
Interested suppliers are required to complete the PQQ to provide information that allows the Authority to evaluate the supplier’s capacities and capabilities against the selection criteria set out at Sections III.2.1) III.2.2) and III.2.3) of this Contract Notice.The Authority will use the PQQ response to create a short-list of tenderers who:(1) Are eligible to participate under Section III.2.1) of this Contract Notice;(2) Fulfil any minimum standards under Sections III.2.2) and III.2.3) of this Contract Notice; and(3) Best meet in terms of capacity and capability the selection criteria set out Sections III.2.2) and III.2.3) of this Contract Notice.
IV.1.3) Reduction of the number of operators during the negotiation or dialogue
IV.2) 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

IV.3) Administrative information
IV.3.1) File reference number attributed by the contracting authority/entity
CBRN/00216
IV.3.2) Previous publication(s) concerning the same contract
No
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
11.10.2016 – 12:00
IV.3.5) Date of dispatch of invitations to tender or to participate to selected candidates
IV.3.6) Language(s) in which tenders or requests to participate may be drawn up
EN
IV.3.7) Minimum time frame during which the tenderer must maintain the tender
In days:
IV.3.8) Conditions for opening of 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. 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.
From 2.2.2014, the Government is introducing its new Government Security Classifications Policy (GSC) to replace the current Government Protective Marking Scheme. A key aspect of this is the reduction in the number of security classifications used. All suppliers to the Department are encouraged to make themselves aware of the changes as it may impact on this Requirement. The link below to the Gov.uk website provides information on the new GSC.

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.
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
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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:
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Suppliers must log in, go to your Response Manager and add the following Access Code: 2388FPVF74.
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GO Reference: GO-201697-DCB-8746905.
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
Body responsible for mediation procedures:
Ministry of Defence, ISTAR, Chemical, Biological, Radiological and Nuclear Delivery Team (CBRN DT)
Bristol
United Kingdom
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
VI.5) Date of dispatch of this notice:
07.09.2016