Public procurement notice: Contract Notice
Published: 2016-09-10
Buyer: Ministry of Defence, ISTAR, Chemical, Biological, Radiological and Nuclear Delivery Team (CBRN DT)
Country: UK
Region: Bristol, City of
Contract type: Services
Procedure: Negotiated procedure
CPV classification: 33000000
Estimated value: 1000000 GBP
Submission deadline: 2016-10-11
Award criteria: The most economic tender

Technical requirements: 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.
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:
(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.

Eligibility requirements: (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.
(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.
The Authority reserves the right to reject any submissions that do not demonstrate sufficient capability and capacity to deliver the advertised requirement.