OMC-Q&A
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OMC
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If I do not participate in the Open Market Consultation events or questionnaire, can I still submit a tender?
Yes, you can. The Open Market Consultation is not part of the selection or pre-qualification process of the ROSIA PCP R&D providers. It is a previous step to canvass wide stakeholder opinion on the suitability of ROSIA PCP.
With the market consultation, the consortium will inform the market about the ROSIA PCP opportunities, explain in detail the PCP process and open a dialogue with potential suppliers and other specialists in the field about the scope of ROSIA with the aim of preparing an accurate future procurement.
Can I receive the participant list from the Market Consultation Phase?
As a company, how can I be sure that during an open market consultation a procurer will not disclose my ideas to other companies/my competitors?
The part of the Guidance for PCP tender documents about how to prepare a Prior Information Notice for an open market consultation clearly highlights that also during an open market consultation, procurers shall respect the confidentiality of the potential tenderers’ information. In particular:
– During an open market consultation, interested tenderers shall be able to indicate to the procurer that is organising the open market consultation which information that they are providing to the procurer is confidential and cannot be disclosed to other market players. Such confidential information should then be provided under a non-disclosure agreement.
As a company, how can I be sure that I receive all the information that the procurer is also providing to other companies?
The part of the Guidance for PCP tender documents about how to prepare a Prior Information Notice for an open market consultation clearly highlights that also during an open market consultation, procurers shall respect the equal treatment, transparency principles. In particular:
– Procurers can during open market consultations (including during face-to-face meetings) not provide information to one potential tenderer without providing that same information to all other potential tenderers. Therefore, procurers should therefore publish all answers that they provided to questions from potential tenderers during the open market consultation (e.g. in the form of a Q&A list). Please note that such Q&A should be anonymised (not mentioned the name of the tenderer who asked the question) and stripped of any references to confidential
solutions/products of specific vendors (to respect the confidentiality/equal treatment principles).
Would bilateral meetings be held during the Open Market Consultation?
Q&A received during OMC proccess
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Can a provider apply directly to Phase 2-3 (e.g. because and advanced TRL), or is it mandatory to start in Phase 1?
Awarded bidders have to address the research challenges of ROSIA.
It is mandatory to start in Phase 1 for the full consortium, although some of the participants could be integrated in Phase 2 or 3.
With the market consultation, the consortium will inform the market about the ROSIA PCP opportunities, explain in detail the PCP process and open a dialogue with potential suppliers and other specialists in the field about the scope of ROSIA with the aim of preparing an accurate future procurement.
What do you mean with "purchasing the design of the technology"? How is different from purchasing a product?
ROSIA PCP is looking for the design of a complete solution, more concretely as a service. Technology is a core component of this service, but not the only one.
The service should also include any other necessary resource to make the solution works, as it could be human resources, updated and maintenance or technology, or managing the local supply chain.
We foresee that the providers will need to create consortia to be able to cover all these needs.
What do you exactly expect in return on the financing provided to the providers at each phase?
Phase 1: Develop the feasibility study of selected solutions from awarded bidders
Phase 2: Prototype development of most promising solutions form Phase I
Phase 3: Validation of best prototyped solutions in real life scenario at each procurer site.
What is the need of the open platform and perfipherals proposed by ROSIA itself, if the selected provider already brings and all-in-one service, including accessories (VR goggles, sensros, smartwatch)? Who is the responsible to developing and (commercially) exploiting it?
The selected provider will bring everything: the open platform as a service, the accessories needed, any other extra resource for the full validation.
The exploitation beyond ROSIA execution is responsibility of the provider.
Procurers participating in ROSIA will have favorable conditions related with the IPR developed during the project execution (see chapter 6.1 Intellectual Property Rights, in the document ROSIA DESCRIPTION FOR THE OMC.)
What happens with the solutions if there is no follow-up PPI? Will the use of the acquired solutions be stopped at the clinical sites?
See chapter 2.4 Exit Plan in the document ROSIA DECRIPTION FOR THE OMC.
How long the selected solution(s) must be provided free of charge to the clients?
The selected solution is not to be provided free of charge to the clients.
The costs related to validation should be included into the Phase 3 budget.
NEW!! Q&A received during OMC proccess
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In terms of licensing and royalties, what is meant exactly by “ROSIA is ready to purchase the design of a technology-enabled service"?
The outcome of the PCP tender will provide procurers with the validated design of a service that, after a subsequent tender, will allow them to deploy the ROSIA model at scale. The fact that the deployment is of a service (and not of a product) means that the contract will be established for a fixed period of time and that the payment of the service will include all necessary licences and royalties.
Because a PCP is a co-creation process funded both by the EU and the procurers, ownership rights over what is developed will have to be established in an initial stage of the process. The criteria set by the EU are described in the Q&A (question 11 of the OMC Q&A). Whatever is agreed in the developmental phases will affect the terms and conditions of IPRs in the subsequent tender.
How is ROSIA’s open platform to be developed exactly? Who will develop it and with what resources?
(Please see chapter 5.3 ROSIA CHALLENGE in ROSIA DESCRIPTION FOR THE OMC)
During the PCP implementation, no components of the system to be integrated are expected to be developed from scratch. Different partners are expected to bring their own existing capacities. The existing budget will pay for the remaining development and integration costs and those of the validation process.
Who manages data collection and processing?
Data from devices connected to the open platform are stored and processed by the ecosystem applications according to established governance rules.
Who certifies the gadgets and applications as medical devices? Will there be clinical trials to be carried out? Who will finance them?
ROSIA is a PCP and as such is a research project. Medical device certifications are not expected during the project. The pilots to be deployed are not clinical trials.
Who exploits ROSIA’s Open Platform commercially (during and after the project)?
The Open Platform is a key element of ROSIA through which medical devices for rehabilitation can be integrated into the general healthcare practice. The public procurers participating in ROSIA are in need of such solutions. However, they are not expected to commit to their acquisition until the project ends, and then only through a subsequent open tender.
What is meant by “elaborating SDK and requirements for the catalogue will be a part of the tender’s requirements”?
ROSIA is not going to purchase the design of a static solution. ROSIA aims to deploy an ecosystem of developers able to integrate new solutions for existing or new pathologies. So, the concrete solutions and devices to be validated during the pilot stage are very important, but the potential of the ecosystem for enabling the growth of the catalogue is also relevant.
Is it necessary to start the project with a TRL=5-6 solution? And if there is a solution already TRL=7-9 ?
ROSIA is a research Project. The overall solution should be a TRL 5-6 at the beginning of the project. However, that doesn’t mean that some of the components can’t be in a more advanced TRL
Will the procurers use their budget to purchase a solution, to develop a solution, or both?
The procurers’ budget is for development and validation.
What kind of economical offer are bidders expected to present?
Bidders should present an economical offer according to the tender specifications.
If there is subsequent no phase 4 (PPI), what happens afterwards to the solutions that have been developed?
(Please see chapter 2.4 Exit Plan in document ROSIA DECRIPTION FOR THE OMC).
TENDERS DOCUMENTS
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What is covered in the Call for Tender?
When do you plan to publish the call for tender and when is the submission deadline?
Can partners be added, or consortia be changed between Phases?
The R&D suppliers will be chosen to enter the PCP competition and to perform the R&D services for Phase 1. After that, the Phase 2 R&D suppliers will be selected from the successful Phase 1 pool R&D suppliers and Phase 3 suppliers will be selected after an internal call-off at the end of Phase 2.
Changes of contractors are not allowed after the PCP competition starts and any changes affecting the R&D suppliers (e.g. subcontractors) must be authorised by the Lead Procurer.
Is there a maximum consortium size?
Can a supplier join more than 1 consortium?
What kind of consortium do you imagine submitting tenders to ROSIA’s RFT?
Do local suppliers (belonging to countries of the ROSIA Buyers Group) have to be included?
Companies need to adhere to the rule from the Horizon 2020 funding scheme regarding the place of performance: we have to request at least 50% of the R&D work needs to take place in EU Member States and/or associated countries to Horizon 2020. However, we can determine a higher rate considering the security sensitive nature of the project.
This rule applies to any tenderer. If suppliers apply as a consortium, this rule applies thus to the consortium as a whole, not to each individual supplier inside a consortium.
Nevertheless, ROSIA PCP project will be validated in regions of 3 european countries, so it is possible that having included some local entities in the supplier’s group could be an advantage.
Can companies from the United Kingdom participate in the PCP?
How will it be possible to submit the tender documents?
All information regarding the tender submission process will be made available through the ROSIA PCP project website, www.rosia-pcp.eu, when the contract notice is published.
Please consult the website.
What is covered in the Framework Agreement?
Will the procurers keep ownership of the IPRs attached to the results during PCP implementation?
According to the European Commission guide on PCP, each contractor will keep ownership of the IPRs attached to the results they generate during the PCP implementation. The tendered price is expected to take this into account.
The ownership of the IPRs will be subject to the following:
– the buyers group has the right to:
* access results, on a royalty-free basis, for their own use
* grant (or to require the contractors to grant) non-exclusive licences to third parties to exploit the results under fair and reasonable conditions (without the right to sub-license)
– The buyers group has the right to require the contractors to transfer ownership of the IPRs if the contractors fail to comply with their obligation to commercially exploit the results or use the results to the detriment of the public interest (including security interests).
Details will be included in the documentation requested for the tender.
Could parties vest the IPR in the public procurer?
When the parties wish to deviate from the default position and vest the IPR in the public procurer, then the IPR will need to be expressly assigned to the other partner by way of an instrument of assignment for copyright or registering the change of ownership in the patent register of the relevant patent office. A clause reflecting the obligations of the parties with respect to the latter should be included in the contract (see EAFIP toolkit)
FINANCING
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What is the budget for the ROSIA PCP?
Could an entity be awarded by ROSIA PCP project if it has already been awarded by other HORIZON 2020 financing?
How is the 3.9 million euros divided throughout the phases for suppliers?
* Phase 1: September-November 2022.
100.000€. 5 potential bidders
* Phase 2: January-August 2023
900.000€. 3 potential bidders
* Phase 3: October 2023-March 2025
2.900.000€. 2 potential bidder
VAT included, if applicable.
Nevertheless, the final distribution will appear in the CFT when published. CFT is expected to be published at the end of March 2022.
Could you directly award the contract for the commercial phase to a finalist of Phase 3?
During the PCP phases, when will the payments be executed: at the beginning or at the end of each phase?
PCP
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Are there any TRL (Technology Readiness Levels) assigned to PCP?
Horizon 2020 itself does not assign specific TRL levels to the implementation of PCPs.
As explained under footnote 40 of the 2014 EU R&D&I State aid framework, TRL 2-4 (industrial research) usually correspond to the type of activities targeted by phase 1 of a PCP and TRL 5-8 (experimental development) with activities targeted by phase 2 and 3 of a PCP.
But in Rosia, we are expecting TRLs from 4 to 8. Validation phase will take place with patients in 6 sites in the 3 countries so solutions should be, at least, validated in the lab.
Do suppliers need to share anything with each other?
It is a competitive process. There is no competitive dialogue. All information regarding the submission of a tender will be provided in the tender documents. It is planned to hold a further briefing webinar to discuss the tender documents. Details will be announced on the project website. Suppliers work in parallel on their own solution and do not need to share any information. In other words, every supplier must answer all requirements fully: an all-inclusive solution is needed from each partner or consortium. After the end of the ROSIA project, suppliers are naturally welcome to join forces and create spin offs.
How will companies be selected in each Phase? Will there be competitive dialogue? Do suppliers need to share anything with each other?
Are you using lots in the PCP?
ROSIA CHALLENGE
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ROSIA proposes to generate a flexible and scalable value-based model of care, organized around self-management, or
self-care of rehabilitation at home, designed from a tailored integrated care model which optimizes the quality of care
and the use of clinical resources. Also a strong implication of the community is needed.
This model of care is extensive in its use of technology:
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- Disruptive solutions at home,
- Data driven interventions, and
- An open platform for third party solutions that integrates timely.
Should bidders solve tele-rehabilitation needs for the seven ROSIA pathologies?
ROSIA is aiming at unlocking the access to ICT solutions for telerehabilitation for patients.
The proposed solutions will initially be validated with the 7 proposed pathologies.
There would be solutions specific for each of the 7 pathologies, while others could be more general and address several of them.
The tender documents will be specific in how this issue will be scored.
Will it be required to have CE certification for medical devices during the ROSIA PCP project?
TRL in the PCP process is expected to evolve from TRL5-6 when preparing the bids, to TRL 7-8 by the end of the project.
The certifications and requirements that will be demanded for Apps and devices to be included in the ROSIA Catalogue, for potential exploitation after project ends, will be defined during the project execution.
