EIT Health DD Services 2021-23

Beschreibung der Beschaffung

Apart from funding, EIT Health provides comprehensive support for innovations that show the potential to have a positive impact on healthcare. The ultimate goal is to transform promising ideas into commercially viable products through a multi-disciplinary approach, involving business, medicine, IT and other fields of knowledge.
EIT Health operates through recruiting collaborative projects to its portfolio (https://www.eithealth.eu/innovation_projects) by publishing once a year a call for proposals in business creation, Education and Innovation programmes. Only project consortia consisting of EIT Health Partners (from 2 different European countries at least) can apply.
In the call for proposals 2022 EIT Health for start-up driven Innovation project, the start-up amplifier instrument is available. It provides the opportunity for start-ups at the core of an innovation project to benefit from extended funding of up to EUR 500 000 in Innovation projects in return for an option to assume shares in the start-up in the case of certain ‘financial events’. This instrument contributes to EIT Health's sustainability strategy and makes EIT Health a magnet for healthcare and life sciences start-ups in Europe for the benefit of our partners.
In the evaluation process (please see Annex 3 for the overview of the EIT Health's evaluation process), EIT Health will evaluate the proposal itself (as it currently does) and the start-up through a due diligence process. Both elements will be considered to define the level of success of an innovation project. If start-up passes the due diligence (none or minor issues identified during due diligence) it will be considered for EIT funding as a part of an Innovation proposal. If start-up does not pass the due diligence (major issues identified during due diligence), Innovation proposal will not be considered for EIT funding.
In parallel with due diligence, a valuation analysis should take place. Valuation analysis should use the established methodologies and result in the pre-money valuation number, that will be communicated to the start-up before it presents Innovation proposal at the hearings.
Additionally, a start-up can select up to two milestones that allow valuation increase during an innovation project duration (i. e. 3 years), given that the pre-defined milestones that significantly de-risk the project/start-up are achieved. This is an optional offer available to the funded start-ups. In case a start-up pursues this offer, an additionally required valuation analysis will be performed following the funding decision to define the valuation increase associated with the timely achievement of milestone(s). The base valuation and milestone-related valuation increase will be fixed at the time of the signature of the option agreement between EIT Health and start-up (prior to the project start).
Moreover, it is possible that the start-up is not incorporated at the time of the call deadline and it will not be possible to perform due diligence and valuation analysis for such start-up prior to the hearings. In such cases, the due diligence and valuation analysis will be performed after the start-up is incorporated (after 1 October 2021).
Finally, when start-up's valuation milestone(s) get achieved, the review and validation of the milestone achievement will take place. The clinical and technological validation will be performed by separately contracted experts outside of the scope of this tender, however, from the business side it will be required to review the start-up's business plan and financials to ensure it follows its business plan in line with the assumptions considered in the milestone-related valuation analysis.
To deliver these services, EIT Health seeks to engage a Service Provider who will perform due diligence and valuation analysis for the start-ups that as a part of an Innovation project with Start-up Amplifier are invited to the hearings and/or funded through the call.
The following services are subject of the contract, in particular within these tentative timeframes:
— preparation work: between 26 April 2021-3 May 2021;
— for the first wave of start-ups (between 15 and 30 start-ups):
• valuation analysis: between 3 May 2021-18 May 2021;
• due diligence: between 19 May 2021-4 June 2021.
— milestone-related valuation analysis (between 3 and 6 start-ups, sub-set of start-ups from the first wave): between 15 September 2021-30 September 2021;
— for the second wave of start-ups (between 0 and 6 start-ups):
• due Diligence: between 8 October 2021-15 October 2021;
• valuation analysis: between 15 October 2021-22 October 2021;
• milestone-revalue valuation analysis: between 22 October 2021-29 October 2021.
— validation of the milestone achievement (business side): individual timeline per each start-up's milestone plan, between 1 and 8 validations per year (in total).
In case of a contract renewal for the years 2022 and 2023, the timeline and number of start-ups might deviate from the ones described above. The tentative timeline and expected number of start-ups will be communicated as a part of the extension confirmation.
The expected maximum number of the various types of services to be provided per year will not exceed:
— due diligence assessments: 36;
— valuation analyses (including milestone-related valuation analyses): 48;
— validations of milestone achievement: 80.

Beschreibung der Verlängerungen

The duration of the contract will be from 26 April 2021 until 31 December 2021. EIT Health e. V. is entitled to unilaterally renew the agreement twice, for 12 months each time, for up to two more Start-up Amplifier programs in 2022 and 2023. The right is to be exercised at the sole discretion of EIT Health e. V. and by written notice to the Service Provider not later than 31 December 2021 (first renewal) and 31 December 2022 (second renewal).
EIT Health reserves the right to optionally award more valuation analysis and/or due diligence services outside of the timeframe set out above. Terms and conditions of the contract (including pricing) apply accordingly.

Liste und kurze Beschreibung der Bedingungen

1) Self-declaration (pursuant to Section 123 (1) to (3) GWB) that no person whose conduct is attributable to the tenderer or a member of the group of economic operators has been convicted, or a fine has been legally established against the economic operator, pursuant to Section 30 OWiG, for an offense against:
— Section 129 of the Criminal Code (Formation of Criminal Associations), Section 129a of the Criminal Code (Formation of Terrorist Associations) or Section 129b of the Criminal Code (Criminals and Terrorist Associations Abroad);
— Section 89c of the Criminal Code (Terrorist Financing) or the participation in such an act or the provision or collection of financial resources, having regard to the fact that these funds are used or intended to be used in whole or in part to commit an offense against Article 89a (2) (2) of the Criminal Code;
— Section 261 of the Criminal Code (money laundering, concealment of unlawfully acquired assets);
— Section 263 of the Criminal Code (Fraud), in so far as the offense is directed against the budget of the European Union or against households managed by or on behalf of the European Union;
— Article 264 of the Criminal Code (subsidy fraud), in so far as the offense is directed against the budget of the European Union or against households managed by or on behalf of the European Union;
— Section 299 of the Criminal Code (corruption and bribery in business dealings);
— Section 108e of the Criminal Code (corruption and bribery of mandate holders);
— Sections 333 and 334 of the Criminal Code (Granting Benefit and bribery) also in connection with § 335a of the Criminal Code (Foreign and International Staff);
— Article 2 (2) of the Law on Combating International Bribery (Bribery of Foreign Members in International Business Transactions); or
— Sections 232, 232a paragraphs 1 to 5, Sections 232b to 233a of the Criminal Code (trafficking in human beings, forced prostitution, forced labor, exploitation of labor, exploitation using a deprivation of liberty).
Or the respective codes of the country of incorporation of the tenderer or the members of the group of economic operators.
2) Self-declaration that the tenderer has fulfilled its obligation to pay taxes, duties and social security contributions (§ 123 (4) GWB);
3) Self-declaration (on facultative exclusion grounds pursuant to § 124 GWB) that
— neither the tenderer's company nor any person whose conduct is attributable to the tenderer has failed to fulfill its obligations under environmental, social or labor law when executing public contracts;
— the tenderer's company is not insolvent, insolvency proceedings or similar proceedings have not been instituted or opened for the assets of the tenderer's company, the opening of such proceedings has not been refused for lack of assets, and the company is not in liquidation or has ceased its activity;
— neither the tenderer's company nor any person whose conduct is attributable to the company has been guilty of grave professional misconduct that calls into question the integrity of the company;
— neither the company nor any person whose conduct is attributable to the company has entered into agreements with other undertakings which have the effect of preventing, restricting or distorting competition;
— the entity has not materially or consistently fulfilled a material breach in the execution of a previous public procurement or procurement contract, resulting in termination, damages or similar legal consequences.

Liste und kurze Beschreibung der Auswahlkriterien

4) Either
— proof (e. g. copy of insurance policy) of a professional civil liability or errors and omissions insurance of the economic operator with a minimum compensation limit of EUR 1 000 000.00 per claim and of EUR 2 000 000.00 per year; or
— self-declaration of the economic operator to contract the respective insurance with this minimum compensation limits in case of award of the contract.
In the case of a group of economic operators as tenderer, each member has to submit this proof or self-declaration for its company.
5) Self-declaration of the total yearly turnover of the economic operator and the turnover of the economic operator in the area of services of similar nature and scope as set out in sections 2.3.1 — 2.3.3 of the procurement and procedure description, based on the last 3 fiscal years (2018 to 2020).
In the case of a group of economic operators as tenderer, the turnover numbers of the members in each of the last 3 fiscal years are added up for the fulfilment of the minimum requirement.

Liste und kurze Beschreibung der Auswahlkriterien

6) Self-declarations (according to the following requirements) of a sufficient level of experience demonstrated by at least 2 reference projects (minimum requirement) of services of similar nature and scope as set out in sections 2.3.1 - 2.3.3 of the procurement and procedure description and rendered in the past 3 years in the EU and preferably also in other markets (i.e. Asia, USA), stating name, address and Email address of a contact person of the contracting body of the reference project and a project name and description of the services provided by the tenderer. EIT Health reserves the right to verify the tenderer's details.
In the case of groups of economic operators it must be clearly indicated which reference project is assigned to which member. The reference projects of the members fulfilling the minimum requirements are attributed to the group of economic operators.

Bedingungen für die Teilnahme (technische und berufliche Fähigkeiten)

At least 2 reference projects (minimum requirement) of services of similar nature and scope as set out in sections 2.3.1-2.3.3 of the of the procurement and procedure description and rendered in the past 3 years in the EU and preferably also in other markets (i.e. Asia, USA), is required.

Genaue Informationen über Fristen für Überprüfungsverfahren

The application for a review procedure at the review body as set out in section VI.4.1) is inadmissible pursuant to § 160 (3) GWB if
1) The applicant has recognized the alleged infringement of public procurement rules prior to the submission of the petition for review and has not issued a complaint to EIT Health within a period of ten calendar days;
2) Infringements of public procurement rules which are discernible on the basis of the contract notice are not notified to EIT Health at the latest by the expiry of the time limit specified in the contract notice for the request to participate or the submission of tenders;
3) Infringements of procurement rules which are discernible on the basis of the procurement documents are not notified to EIT Health at the latest by the expiry of the time limit specified in the contract notice for the request to participate or the submission of tenders;
4) More than 15 calendar days have elapsed after receipt of the notification by EIT Health to not remedy a complaint of the tenderer.

Beschreibung der Beschaffung

Apart from funding, EIT Health provides comprehensive support for innovations that show the potential to have a positive impact on healthcare. The ultimate goal is to transform promising ideas into commercially viable products through a multi-disciplinary approach, involving business, medicine, IT and other fields of knowledge.
EIT Health operates through recruiting collaborative projects to its portfolio (https://www.eithealth.eu/innovation_projects) by publishing once a year a call for proposals in business creation, education and innovation programmes. Only project consortia consisting of EIT Health Partners (from 2 different European countries at least) can apply.
In the Call for proposals 2022 EIT Health for start-up driven Innovation project, the Start-up Amplifier Instrument is available. It provides the opportunity for start-ups at the core of an Innovation project to benefit from extended funding of up to EUR 500 000 EUR in Innovation projects in return for an option to assume shares in the start-up in the case of certain ‘financial events’. This instrument contributes to EIT Health's sustainability strategy and makes EIT Health a magnet for healthcare and life sciences Start-ups in Europe for the benefit of our Partners.
In the evaluation process (please see Annex 3 for the overview of the EIT Health's evaluation process), EIT Health will evaluate the proposal itself (as it currently does) and the start-up through a due diligence process. Both elements will be considered to define the level of success of an Innovation project. If start-up passes the due diligence (none or minor issues identified during due diligence) it will be considered for EIT funding as a part of an Innovation proposal. If start-up does not pass the due diligence (major issues identified during due diligence), Innovation proposal will not be considered for EIT funding.
In parallel with due diligence, a valuation analysis should take place. Valuation analysis should use the established methodologies and result in the pre-money valuation number, that will be communicated to the start-up before it presents Innovation proposal at the hearings.
Additionally, a start-up can select up to two milestones that allow valuation increase during an Innovation project duration (i. e. 3 years), given that the pre-defined milestones that significantly de-risk the project/start-up are achieved. This is an optional offer available to the funded start-ups. In case a start-up pursues this offer, an additionally required valuation analysis will be performed following the funding decision to define the valuation increase associated with the timely achievement of milestone(s). The base valuation and milestone-related valuation increase will be fixed at the time of the signature of the Option Agreement between EIT Health and start-up (prior to the project start).
Moreover, it is possible that the start-up is not incorporated at the time of the call deadline and it will not be possible to perform due diligence and valuation analysis for such start-up prior to the hearings. In such cases, the due diligence and valuation analysis will be performed after the start-up is incorporated (after October 1, 2021).
Finally, when start-up's valuation milestone(s) get achieved, the review and validation of the milestone achievement will take place. The clinical and technological validation will be performed by separately contracted experts outside of the scope of this tender, however, from the business side it will be required to review the start-up's business plan and financials to ensure it follows its business plan in line with the assumptions considered in the milestone-related valuation analysis.
To deliver these services, EIT Health seeks to engage a service provider who will perform due diligence and valuation analysis for the start-ups that as a part of an innovation project with start-up amplifier are invited to the hearings and/or funded through the Call.
The following services are subject of the contract, in particular within these tentative timeframes:
— preparation work: between 26 April 2021 — 3 May 2021,
— for the first wave of start-ups (between 15 and 30 start-ups):
• valuation analysis: between 3 May 2021 — 18 May 2021;
• due diligence: between 19 May 2021 — 4 June 2021.
— milestone-related valuation analysis (between 3 and 6 start-ups, sub-set of start-ups from the first wave): between 15 September 2021 — 30 September 2021
— for the second wave of start-ups (between 0 and 6 start-ups):
• Due Diligence: between 8 October 2021 — 15 October 2021;
• valuation analysis: between 15 October 2021 — 22 October 2021;
• milestone-revalue valuation analysis: between 22 October 2021-29 October 2021.
— validation of the milestone achievement (business side): individual timeline per each start-up"s milestone plan, between 1 and 8 validations per year (in total).
In case of a contract renewal for the years 2022 and 2023, the timeline and number of start-ups might deviate from the ones described above. The tentative timeline and expected number of start-ups will be communicated as a part of the extension confirmation.
The expected maximum number of the various types of services to be provided per year will not exceed:
— due diligence assessments — 36,
— valuation analyses (including milestone-related valuation analyses) — 48,
— validations of milestone achievement — 8.

Genaue Informationen über Fristen für Überprüfungsverfahren

The application for a review procedure at the review body as set out in section VI.4.1 is inadmissible pursuant to § 160 (3) GWB if
1) The applicant has recognized the alleged infringement of public procurement rules prior to the submission of the petition for review and has not issued a complaint to EIT Health within a period of ten calendar days;
2) Infringements of public procurement rules which are discernible on the basis of the contract notice are not notified to EIT Health at the latest by the expiry of the time limit specified in the contract notice for the request to participate or the submission of tenders;
3) Infringements of procurement rules which are discernible on the basis of the procurement documents are not notified to EIT Health at the latest by the expiry of the time limit specified in the contract notice for the request to participate or the submission of tenders;
4) More than 15 calendar days have elapsed after receipt of the notification by EIT Health to not remedy a complaint of the tenderer.