Tender Specifications

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1 Tender Specifications Service contract for consultancy services to develop sustainability plans for IMI project outcomes Document reference: IMI.2015.SC.030 1

2 Contents 1 Introduction Background IMI JU Scope and nature of the assignment General guidelines for participants Timetable What should my offer consist of? Contacts between IMI JU and the tenderer Data protection Subcontracting Tender specifications: Criteria Exclusion criteria Selection criteria Award criteria Technical Award criteria Price Award criteria Final score Standard Forms to be filled in Annex 1. Declaration of honour with respect to the Exclusion Criteria and absence of conflict of interest Annex 2. Tenderer s administrative data Annex 3. Financial identification and legal entity forms

3 1 Introduction 1.1 Background IMI JU The Innovative Medicines Initiative (IMI JU), a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) was established in 2009 with the primary objective to improve the efficiency and effectiveness of the medicines development process. The long-term aim is to bring more effective and safer innovative medicines to patients. IMI funds projects carried out by multinational, cross-sector consortia in research, development and training. The projects are financed via grants awarded following competitive calls for proposals and evaluation by independent experts. Since 2009, the IMI Executive Office (EO) has launched 15 Calls for proposals consisting of 80 Call topics that resulted in currently 67 on-going public-private partnership projects, addressing a variety of bottlenecks in medicines development and more generally in healthcare. The earliest IMI projects are now in their fifth year, and many projects have started to produce impressive results. More at: Scope and nature of the assignment The projects funded by IMI JU are of a fixed duration, typically 3-5 years. Apart from intellectual property, the use of which is determined in the project agreements, the projects generate various other types of assets that can have commercial and/or societal (e.g. facilitating future research, improving regulatory process, etc.) value beyond the project duration. Examples of such assets include databases, bio-banks, software and infrastructures for training and research. Plans to make such assets sustainable beyond the project lifetime and IMI grant funding are not systematically included in the scope of the projects. However, we want to ensure that these potentially valuable products of the projects are exploited to their maximum potential also after the projects have been concluded. With the current tender, we are seeking to find a contractor for a pilot study to develop the selfsustainability of such assets. The assignment: The awarded contractor is expected to carry out a consultancy assignment on four IMI funded projects in three steps Step 1: Identify and evaluate assets that have potential to be self-sustaining from a financial and operational perspective and usefully exploited after the project end-date; Duration: approximately 2 months per project Deliverable: report on the identified asset(s) and their potential commercial/societal value Step 2: Identify the most viable mechanism for self-sustainability of these assets beyond the project end- Duration: approximately 3-4 months per project Deliverable: report on the most viable mechanism(s) for self-sustainability Step 3: Develop a business plan for the implementation of the self-sustainability mechanism identified. Duration: approximately 4-6 months per project depending on complexity; Deliverable: Business plan for implementing the self-sustainability mechanism(s) The steps and tasks for the four projects shall be planned in parallel, so that the maximum delay for completing all steps and having delivered all the final deliverables to IMI JU is 12 months from the contract signature date. The exact schedule for carrying out the different steps for the four projects shall be agreed between IMI and the awarded contractor. 3

4 The four projects that are the subject of the assignment will be identified by IMI for the selected contractor. The projects to be studied are all approaching their conclusion, with end-dates between 2015 and The awarded contractor will work closely with the organisations participating in the project as well as the IMI executive office as appropriate. Actual implementation of the business plan is not included in the current contract. The budget and payments: The maximum budget for the entire assignment covering all related costs and expenses is EUR Partial payments may be made at the completion of the steps for each of the four projects studied, subject to approval of IMI. The bid: To compete for the award of this contract, you should submit a bid no later than 7 March 2015 by to the address procurement@imi.europa.eu. Your bid must be submitted respecting the deadline and other guidelines as described under Chapter 2 below. It should contain all the elements listed under Chapter 2.2 below. The contract: The model direct service contract is published together with these tender specifications. The awarded tenderer is expected to accept these contract terms. 4

5 2 General guidelines for participants 2.1 Timetable The timetable for this tender and the resulting contract is as follows: Activity Date Comments Launching of tender [20/02/2015] Dispatch of contract notice to a minimum of 5 candidates by and publication on the website Deadline for request for clarifications from the IMI JU [27/02/2015] By only to procurement@imi.europa.eu Last date for clarifications issued by the IMI JU [04/03/2015] Clarifications will be published on the website Deadline for submission of offers [06/03/2015] By to the address procurement@imi.europa.eu no later than 18:00 CET Date for evaluation of offers [11/03/2015] Estimated Notification of award/rejection to tenderers [13/03/2015] Estimated What should my offer consist of? Tenderers must submit an offer that includes the following 3 elements: A. Technical proposal For selection criteria, i.e. assessment of the tenderer s technical and professional capacity to carry out the assignment, you are required to submit: Examples of three similar assignments in the past three years including a brief description indicating why the contract is comparable to the current assignment and the type of client (e.g. pharmaceutical company, SME, regulator, etc; no names of clients are required). For the current assignment, you are required to submit a proposal consisting of A description of your methodology for carrying out the assignment as described above in Chapter 1.2. Your technical proposal will be evaluated for the quality of the methodology and the level of understanding of the pharmaceutical sector and the context and goals of IMI that is demonstrated. 5

6 B. Financial proposal Your financial proposal shall consist of a single figure for the entire assignment, including all expenses and covering all the aspects in your technical proposal and resulting in the deliverables listed in Chapter 1.2. The price must be quoted in EURO. The financial proposal must be submitted on a separate document. The price must be quoted free of all duties, taxes and other charges (including VAT) as the IMI JU is exempt from such charges under Articles 3 and 4 of the Protocol on the privileges and immunities of the European Union. C. Supporting documentation The supporting documentation is an important part of your offer and must be complete to guarantee that your technical proposal will be evaluated. The supporting documentation must contain the following 2 elements: Declaration on honour duly dated and signed (Annex 1) Tenderer s administrative information (Annex 2) In addition, the following will be requested from the awarded contractor only before the signature of the contract: Legal entity form and financial identification form (Annex 3) This information is necessary to allow IMI JU to produce the contractual documentation in the event you are the selected contractor. This information is particularly important for payments, since payments will be made by bank transfer to the account indicated by the tenderer in the standard forms Contacts between IMI JU and the tenderer Requests for clarification regarding this procurement procedure or the nature of the contract should be done in writing only and should be sent by to: procurement@imi.europa.eu The deadline for clarification requests is 27 February Each request for clarification sent to the IMI JU should indicate the reference number and the title of the tender. The IMI JU will provide additional information resulting from the request for a clarification. Moreover, in case the IMI JU discover an error, a lack of precision, an omission or any other type of clerical defect in the text of the contract notice or in the tender specifications, the IMI JU will also inform all invited candidates by . If, after the tenders have been opened, some clarification is required in connection with a tender, or if obvious clerical errors in the submitted tender must be corrected, the IMI JU may contact the tenderer, although such contact may not lead to any alternation of the terms of the submitted tender. 2.4 Data protection In the general implementation of their activities and for the processing of tendering procedures in particular, the JUs observe the following EU regulations: Regulation (EC) No. 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents. 6

7 Regulation (EC) No. 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data Processing your reply to the tender specifications will involve the recording and processing of personal data (such as your name, address and CV). Such data will be processed pursuant to Regulation (EC) No 45/2001 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data. Unless indicated otherwise, your replies to the questions and any personal data requested are required to evaluate your tender in accordance with the tender specifications and will be processed solely for that purpose by the JUs. You are entitled to obtain access to your personal data on request and to rectify any such data that is inaccurate or incomplete. If you have any queries concerning the processing of your personal data, you may address them to the IMI s Data Protection Officer (Postal address: IMI JU TO 56 Office 6/22 B-1049 Brussels). You have the right of recourse at any time to the European Data Protection Supervisor for matters relating to the processing of your personal data. 2.5 Subcontracting If applicable, the tenderer must indicate clearly which parts of the work will be sub-contracted. If subcontracting is envisaged the volume/proportion of the tender being subcontracted for each subcontractor must be specified in the tender. Sub-contractors must satisfy the eligibility criteria applicable to the award of the contract. If the identity of the intended sub-contractor(s) is already known at the time of submitting the tender, all sub-contractors must provide the required evidence for the exclusion and selection criteria. If the identity of the sub-contractor is not known at the time of submitting the tender, the tenderer who is awarded the contract will have to seek the JUs prior written authorisation before entering into a sub-contract. Where no sub-contractor is given, the work will be assumed to be carried out directly by the tenderer. 7

8 3 Tender specifications: Criteria 3.1 Exclusion criteria In accordance with the terms set in Article 143 of the Implementing Rules of the Financial Regulation, tenderers shall provide a declaration on their honour, duly signed and dated, stating that they are not in one of the situations referred to in Articles 106 and 107 of the Financial Regulation. The declaration on honour, based on the template in Annex 1 hereafter, shall be included in the offer, duly signed and dated Selection criteria In accordance with the terms set in Article of the Implementing Rules of the Financial Regulation, the contracting authority chose not to ask the candidate to provide documentary proof of financial and economic capacity. The criterion for technical and professional capacity is sufficient previous experience of similar assignments in the pharmaceutical sector. As evidence, tenderers are requested to submit examples of three relevant assignments in the past five years including a brief description indicating why the contract is comparable to the current one and the type of client (Pharma company, SME, regulator, etc; no names of clients are required). Only those tenderers satisfying these criteria will have their proposals evaluated for the award of the contract. 3.3 Award criteria Technical Your price offer counts for 30% of the final evaluation score (see chapter 3.4 below), while the score of the evaluation against the technical criteria counts for 70%. Your technical proposal will be evaluated for the quality of the methodology; and the level of understanding of the pharmaceutical sector and the context and goals of IMI that is demonstrated. The maximum score for the technical criteria is 100 points. Any bid scoring less than half (50%) of the points for technical criteria mentioned above shall be eliminated from the evaluation. 3.4 Award criteria Price Price of the offer counts for 30% of the final evaluation score, while compliance with the technical criteria counts for 70% (the quality of your offer in this respect is measured against the technical criteria described above). 3.5 Award criteria Final score The final score for offers will be calculated as follows: 8

9 Score for tender X = Cheapest price Price of tender X * Price weighting (in absolute value) + Total quality score (out of 100) for all awarded criteria of tender X * Quality criteria weighting (in absolute value) 100 Price weighting = 30; Quality weighting = 70. 9

10 4 Standard Forms to be filled in The standard forms are to be completed and provided as part of your offer. The forms in annex are: Annex 1 Declaration of honour with respect to the Exclusion Criteria and absence of conflict of interest Annex 2 Tenderer s administrative data Annex 3 Financial identification and legal entity forms 10

11 Annex 1. Declaration of honour with respect to the Exclusion Criteria and absence of conflict of interest 2 pages to be completed and signed by the tenderer The undersigned: or in his/her own name (if the economic operator is a natural person or in case of own declaration of a director or person with powers of representation, decision making or control over the economic operator) representing (if the economic operator is a legal person) official name in full (only for legal person): official legal form (only for legal person): official address in full: VAT registration number: declares that the company or organisation that he/she represents he/she: a) is not bankrupt or being wound up, is not having its affairs administered by the courts, has not entered into an arrangement with creditors, has not suspended business activities, is not the subject of proceedings concerning those matters, and is not in any analogous situation arising from a similar procedure provided for in national legislation or regulations; b) has not been convicted of an offence concerning professional conduct by a judgment which has the force of res judicata; c) has not been guilty of grave professional misconduct proven by any means which the contracting authorities can justify; d) has fulfilled all its obligations relating to the payment of social security contributions and the payment of taxes in accordance with the legal provisions of the country in which it is established, with those of the country of the contracting authority and those of the country where the contract is to be carried out; e) has not been the subject of a judgement which has the force of res judicata for fraud, corruption, involvement in a criminal organisation or any other illegal activity detrimental to the Communities financial interests; f) is not a subject of the administrative penalty for being guilty of misrepresentation in supplying the information required by the contracting authority as a condition of participation in the procurement procedure or failing to supply an information, or being declared to be in serious breach of his obligation under contract covered by the budget. 11

12 In addition, the undersigned declares on their honour: g) they have no conflict of interest in connection with the contract; a conflict of interest could arise in particular as a result of economic interests, political or national affinities, family or emotional ties or any other relevant connection or shared interest; h) they will inform the contracting authority, without delay, of any situation considered a conflict of interest or which could give rise to a conflict of interest; i) they have not made and will not make any offer of any type whatsoever from which an advantage can be derived under the contract; j) they have not granted and will not grant, have not sought and will not seek, have not attempted and will not attempt to obtain, and have not accepted and will not accept any advantage, financial or in kind, to or from any party whatsoever, constituting an illegal practice or involving corruption, either directly or indirectly, as an incentive or reward relating to award of the contract; k) that the information provided to JUs within the context of this invitation to tender is accurate, sincere and complete; l) that in case of award of contract, they shall provide the evidence that they are not in any of the situations described in points a, b, d, e above. For situations described in (a), (b) and (e), production of a recent extract from the judicial record is required or, failing that, a recent equivalent document issued by a judicial or administrative authority in the country of origin or provenance showing that those requirements are satisfied. Where the Tenderer is a legal person and the national legislation of the country in which the Tenderer is established does not allow the provision of such documents for legal persons, the documents should be provided for natural persons, such as the company directors or any person with powers of representation, decision making or control in relation to the Tenderer. For the situation described in point (d) above, recent certificates or letters issued by the competent authorities of the State concerned are required. These documents must provide evidence covering all taxes and social security contributions for which the Tenderer is liable, including for example, VAT, income tax (natural persons only), company tax (legal persons only) and social security contributions. For any of the situations (a), (b), (d) or (e), where any document described in two paragraphs above is not issued in the country concerned, it may be replaced by a sworn or, failing that, a solemn statement made by the interested party before a judicial or administrative authority, a notary or a qualified professional body in his country of origin or provenance. By signing this form, the undersigned acknowledges that they have been acquainted with the administrative and financial penalties described under art 133 and 134 b of the Implementing Rules (Commission Regulation 2342/2002 of 23/12/02), which may be applied if any of the declarations or information provided prove to be false. Full name Date Signature 12

13 Annex 2. Tenderer s administrative data Address and contact details Tenderer Name Address Post Code Tel Fax Website (if applicable) Legal Status Contact person for this tender Legal signatory(ies) Annex 3. Financial identification and legal entity forms The financial identification and legal entity forms are to be downloaded from the following websites: Financial identification: Legal entities: 13

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