Brochure: Call for proposals Earlier recognition of cardiovascular diseases

Brochure: Call for proposals ‘Earlier recognition of cardiovascular diseases’ Part A: Collaboration between academia and industry (Partnership programme: Dutch Heart Foundation – Technology Foundation STW ) Part B: Academia only (Dutch Heart Foundation CVON)

Version 25 August (published on STW website on 28 August)

Deadline preproposals: 14 September 2015 Deadline full proposals: 15 December 2015

Table of contents General information ................................................................................................................................................. 4 Background .................................................................................................................................................................... 4 Content of this brochure.................................................................................................................................................. 5 Focus and objectives ...................................................................................................................................................... 5 Criteria for proposals ...................................................................................................................................................... 7 Project proposals not eligible for this programme............................................................................................................ 9 Applications .................................................................................................................................................................... 9 Budget ............................................................................................................................................................................ 9 Who can apply? ............................................................................................................................................................ 10 Points of attention ......................................................................................................................................................... 10 Eligibility requirements for preproposals and full proposals ........................................................................................... 11 Preproposals – Deadline 14 September 2015, 14.00 hours .......................................................................................... 12 Full proposals – Deadline 15 December 2015, 14.00 hours .......................................................................................... 12 Procedure ..................................................................................................................................................................... 12 NWO Code of Conduct on Conflicts of Interest ............................................................................................................. 14 Agreements .................................................................................................................................................................. 14

Contact information programme committee secretary ........................................................................................... 15 Specific requirements part A.................................................................................................................................. 16 Selection procedure ...................................................................................................................................................... 16 Co-funding .................................................................................................................................................................... 18 After award ................................................................................................................................................................... 19 Who can apply? ............................................................................................................................................................ 19 Guidelines for applicants............................................................................................................................................... 20 Project-specific costs .................................................................................................................................................... 20 Notes on costs of personnel temporarily appointed to the project at the research institute ............................................ 20 Notes on costs of materials and domestic travel ........................................................................................................... 23 Notes on costs of foreign travel..................................................................................................................................... 23 Notes on costs of investments ...................................................................................................................................... 24 Notes on Users, co-funding and letters of support......................................................................................................... 25 Notes on Intellectual Property Policy & Publication arrangements................................................................................. 28

Specific requirements part B.................................................................................................................................. 31 Selection procedure ...................................................................................................................................................... 31 Who can apply? ............................................................................................................................................................ 34 Description of full proposals .......................................................................................................................................... 34 Project-specific costs .................................................................................................................................................... 35 Users ............................................................................................................................................................................ 36 After award ................................................................................................................................................................... 36

Appendix 1............................................................................................................................................................. 37 Existing research consortia of projects linked to ‘Earlier recognition of cardiovascular diseases’ (not a comprehensive list, guideline)................................................................................................................................................................ 37

Appendix 2............................................................................................................................................................. 40 Format Preproposal ...................................................................................................................................................... 40 Pagina 2 van 62

Appendix 3............................................................................................................................................................. 41 Partnership Project Agreement template (Part A).......................................................................................................... 41

Appendix 4............................................................................................................................................................. 51 Consortium agreement template (Part B) ...................................................................................................................... 51

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General information Background STW and the Dutch Heart Foundation (DHF) are proud to announce a joint programme for the earlier recognition of cardiovascular diseases, which combines the strengths and strategies of both organisations: knowledge transfer between technical sciences and direct users and end users and the realisation of consortia focussed on important health issues. DHF is a charity that funds research, education, and awareness campaigns aimed at reducing the burden of cardiovascular disease in the Netherlands. In 2014, DHF together with scientists, patients and the general public set a research agenda based on urgency and impact. The theme ‘Earlier recognition of cardiovascular diseases’ came at the top of this agenda.

Every day in the Netherlands: •

107 people die due to a cardiovascular disease: 57 women and 50 men

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27 people die before the age of 75 due to cardiovascular diseases

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1000 people are admitted to a hospital due to cardiovascular diseases

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more than 1 million people live with the consequences of a cardiovascular disease

Since 2010, part of DHF's funding strategy has been aimed at encouraging collaboration at the national level, with the best researchers collaborating in the most promising research areas in the Netherlands. No longer competing, but combining forces to face international competition. The funding of individual PhD projects has been replaced by the funding of national consortia. This transforms the competition between individual research projects and people into collaboration between research groups. These consortia are committed to solving a healthcare problem and are multidisciplinary and translational in nature. This strategy is now better known as the CVON (CardioVasculair Onderzoek Nederland) initiative. Technology Foundation STW (STW) is a funding agency whose mission is to generate knowledge transfer between the technical sciences and users. STW enables new technology by funding applied scientific research and promoting technology transfer. The partnership programme is one of STW's funding instruments, with the specific goal of engaging Dutch research-based organisations in a collaborative relationship with STW and Dutch universities. Earlier recognition of cardiovascular disease is an important societal challenge that calls for the engagement of both excellent researchers and direct users and end users. In many cases industrial parties will be among the users of the research results, which they can develop into products and/or services. As STW has extensive experience in selecting and monitoring research projects with industrial participation, DHF and STW have decided to join forces and set up a partnership programme as part of this call for proposals on earlier recognition of cardiovascular disease. The participation of industry is a requirement for this DHF-STW partnership programme.

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We invite academic scientists to submit preproposals for research projects that may give answers to the scientific and technological challenges described below.

Content of this brochure This brochure consists of three parts. The first part describes the focus and objectives of this programme and all important directions for your research proposal. In the second part specific requirements for respectively part A and part B of this call for proposals are given. The third part consists of several important appendices you should consult before submitting your proposal. Before submitting your application, we recommend that you visit the websites of STW (www.stw.nl) and DHF (www.hartstichting.nl) to check that you use the latest version of this brochure and appendices, and that you read the guidelines carefully. If you have any questions, please do not hesitate to contact any of the contact persons. Contact details are given at the end of the first part (General information) of this brochure.

Focus and objectives 1.

Description of theme

This programme focuses on ‘Earlier recognition of cardiovascular diseases’ Never your old self after a myocardial infarction, partly paralysed after a stroke or even deceased after a cardiac arrest. A cardiovascular disease: can happen to anyone. Many cardiovascular diseases hit unexpectedly. For instance a stroke or myocardial infarction, or a cardiac arrest can occur suddenly without clear prior complaints. The consequences can be disastrous: irreparable damage or even fatal. Yet, however unexpected they might seem, cardiovascular diseases often do not come out of the blue. This theme concerns confirming or excluding the diagnosis of cardiovascular disease faster in people with ‘vague’ or initial symptoms, people with a family history and people with other diseases like diabetes, COPD, rheumatic arthritis and depression. These other diseases are associated with a significantly increased risk of cardiovascular diseases and/or hinder the recognition of a cardiovascular disease because they exhibit similar symptoms. Research into the earlier recognition of cardiovascular diseases will allow us to diagnose cardiovascular diseases before they strike seriously. We can save lives and prevent the sequelae of cardiovascular diseases as much as possible. Ultimately, this will lead to an improvement in quality of life and savings in healthcare costs because these people will require less care and live with fewer limitations. More information about this theme can be found on the website (in Dutch): www.hartstichting.nl/onderzoek/eerder-herkennen-hart-en-vaatziekten

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2.

Aim of the programme

We want to recognise cardiovascular diseases sooner. This will allow us to treat these diseases before they become serious, thus saving lives and preventing irreparable damage. 3.

Long term ambition

By 2030 we recognise 25% more patients developing cardiovascular diseases before they suffer a serious clinical event. People may not be aware that they have a cardiovascular disease or a hereditary tendency to develop one. We want to recognise cardiovascular diseases sooner so that these people can be treated, alleviating the symptoms and reducing the incidence of severe complications. By 2030 we want to be able to recognise 25% of developing cardiovascular diseases sooner, thus reducing the number of untreated people with cardiovascular diseases by 25%. This will lead to fewer fatalities, fewer people developing irreparable damage, and fewer people living with symptoms or restrictions. The secondary objectives stated below – which are strongly interrelated - give an idea of the different areas involved to achieve this goal: a. By 2020 we know which symptoms point to cardiovascular diseases. Initial symptoms can point to one condition or to several cardiovascular diseases. By 2020 we will know which symptoms are warning signs of a severe cardiovascular disease for at least three cardiovascular diseases unknown at this moment. b. By 2020 people will be able to ascertain for themselves whether they have cardiovascular diseases in their family history. People are becoming increasingly aware that cardiovascular diseases can have a hereditary basis and that it is important to know whether cardiovascular diseases occur in their family history. By 2020 people will be able to determine whether – and which - cardiovascular diseases have occurred in their family. From 2020 this will become possible for more and more cardiovascular diseases. Additionally doctors will be able to increasingly use this information better to recognise cardiovascular diseases. c. By 2025 people will be able to recognise on their own which symptoms require a visit to the doctor. People will know which symptoms, suggestive of a cardiovascular disease, to watch out for. By 2025 at the latest a digital checklist will be available that can determine whether someone with particular symptoms should consult a doctor. And doctors will be able to increasingly use this information better for the earlier recognition of cardiovascular diseases. d. By 2030 there will be new tests and diagnostic strategies available to diagnose or exclude the presence of cardiovascular diseases. New or improved tests, techniques and diagnostic strategies will allow doctors and/or laypeople to confirm or exclude cardiovascular diseases at an early stage.

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4.

Which diseases are of interest?

The focus lies on ‘severe’ cardiovascular diseases, thus all diseases that can lead to sudden death or significant restrictions in activities of daily living. It is restricted to diseases for which an effective treatment is or will be available if they are diagnosed early. The following cardiovascular diseases are of interest for this theme: •

Aneurysm

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Stroke

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Atrial fibrillation

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Deep venous thrombosis

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Heart failure

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Myocardial infarction

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Peripheral vascular disease

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Pulmonary embolism

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Pulmonary hypertension

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Sudden cardiac death due to fatal arrhythmia

We distinguish two target groups for this research: 1. People with symptoms 2. People (with or without symptoms) at high risk of cardiovascular diseases given their family history.

Criteria for proposals Utilisation Research funded by this programme generates valuable knowledge. In addition to excellent science, STW and DHF promote the application of knowledge. The term used to refer to the set of activities aimed at maximising the possibility of research results being applied by third parties is ‘utilisation’. To promote utilisation in addition to scientific quality, a user committee is set up for every project. STW and DHF expect applicants and users to actively collaborate towards promoting utilisation and towards the objective of transferring knowledge to users. Users, user committees and intellectual property play a crucial role in utilisation. Please consult the ‘specific requirements’ sections of the user committees of each part of this call. Linking to strong national research programmes There must be sufficient knowledge and critical mass to arrive at the application of a positive research result. To increase national research collaborations and the possibility that the results of the present call lead to clinical applications and/or change of current guidelines, we strongly advise linking the application with strong national, disease-driven research groups, if this is possible with regards to the topic of research that is planned in that project. Pagina 7 van 62

Examples to link with are current disease-driven consortia funded by DHF, European consortia with Dutch participants and other major research programmes funded by ZonMw, LSH Plaza, KNAW and STW (including, but not limited to the list in Appendix 1). A letter confirming the collaboration with the existing consortium and signed by the consortium leader must be included in the preproposal. The added synergistic value (e.g. exchange of data or infrastructure, increase interaction) of the collaboration should be described and argued. It is not the intention that consortia fuse. Each consortium will continue to function independently but exchange should be organised. If you cannot connect with existing consortia then you should explain why in a letter, both if there is not a consortium to link to with regards to the topic of the planned research and also when content wise a link could be possible but there are reasons not to get this in place. Translational and innovative research This call is looking for innovative, translational and multidisciplinary research that uncovers new paths that help to achieve the objectives of the call. The research fitting in this programme is wideranging: it could involve developing new technologies, e.g. devices, imaging for early recognition of cardiovascular disease or a new way to combine and implement existing knowledge, technology and tests or look at processes in the early stages of developing cardiovascular diseases that can lead to the development of a new test or diagnostic strategy. Applicants should specifically argue the innovative character of their proposal and clearly describe in which way their work will contribute to the objective of this call. Sharing and registering data An infrastructure for follow-up research needs to be created to ensure the fast translation of the research into the earlier recognition of cardiovascular diseases in clinical practice. Researchers in this call must be prepared to share their data, making use of existing registries (like the Rotterdam study or Lifelines) or contributing to the development of a new registry. Research that focuses exclusively on setting up a registry/database is not allowed. ‘Earlier recognition of cardiovascular diseases’ in women ‘Women and cardiovascular diseases’ is the second topic on the research agenda of DHF. All research proposals must clearly describe the contribution to the study of gender aspects. Research proposals on new technologies should identify how these technologies can potentially be applied for early recognition of cardiovascular diseases in men and women. Multidisciplinary research team A research proposal must be jointly submitted by at least two researchers who are employed by at least two different public research institutes that are eligible for STW and DHF funding. The main applicant is considered to be the project leader and the contact person throughout the procedure. The research teams must be multidisciplinary and can consist of expertise from all stages of the translational axis: from fundamental scientists to clinical scientists and/or general practitioners. Along with researchers, users (doctors and patients) must be involved in the research at an early stage.

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For Part A, the exchange of research personnel between universities and companies in the consortium is highly encouraged.

Project proposals not eligible for this programme • •

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Research that primarily leads to cardiovascular risk management instead of early diagnosis. Research into conditions for which there is no (effective) treatment currently available, except if the relevance for achieving the objective can be convincingly demonstrated (for example, a treatment will soon become available). Research into the pathophysiology of cardiovascular diseases with little potential to contribute to the earlier recognition of the disease in practice. Projects not leading to a significant step forward along the translational axis. Translation could, for example, mean from an animal to a patient or from a laboratory to a patient and/or industry. Research into hereditary factors of non-life-threatening diseases or risk factors for cardiovascular diseases (see above). The theme focuses on ‘severe’ cardiovascular diseases, or cardiovascular diseases that can lead to a sudden death or permanent limitations. Conducting screenings. NB: research that can lead to establishing a screening programme can be submitted. Research that focuses exclusively on setting up a registry/database.

Applications This call consists of two parts: part A (partnership programme STW and DHF) is looking for applications built on a collaboration between academia and industry, part B (DHF) is academia only.

Call: Earlier recognition of cardiovascular disease Industry involved? yes no Part A

Part B

The description given below applies to both parts unless explicitly stated otherwise.

Budget The maximum funding that can be requested for a project is 950,000 euros (incl. Dutch VAT). The maximum project duration is 5 years. For part A, a total budget of 4,75 million euros (incl. Dutch VAT) is available. STW and DHF will each contribute 2.375 million euros. For part B, a total budget of at least 4,75 million euros, financed by DHF, is available.

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Who can apply? Scientists employed by Dutch universities or para-academic institutes eligible for STW or DHF funding can submit a preproposal or a full proposal (see more specific information in ‘Specific requirements for part A and B’). On approval of the project, the applicant becomes the project leader and bears ultimate responsibility for the realisation of the research including the utilisation plan. A principle investigator (or co-applicant) must play an active role (associate supervisor and/or daily supervision of researchers appointed to the project) in the realisation of the project. Project leader • must work in a paid position at an eligible institution throughout the entire duration of the research project. A letter must be included containing proof of a paid position; •

has shown leadership and is capable of leading a project of this size;

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has an excellent track record and an evident international reputation and has the potential to successfully face European competition (the minimal level we are looking for is eligible for at least a Vidi or an ERC starting grant);

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can only be the research leader of one application. Project leaders awarded grants from previous CVON calls and from the Heart Foundation calls (‘Women and CVD’ and ‘Congenital Heart Disease’) in 2013 can only act as principal investigator.

Principal Investigator/co-applicant • is leading part of the project (work package); •

must be employed throughout the entire duration of the research project. If not, specific details must be supplied of what measures will be taken to deal with this;

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must be capable of making/guaranteeing agreements on behalf of the institute were she/he is employed (probably in consultation with the head of the department);

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has a proven track record and reputation (at least eligible for a Veni grant).

Points of attention •

Users Users of research are defined as natural persons or legal persons (at national or international level) who are able to apply the results of the research. A distinction is sometimes drawn between direct users, usually companies, and end users. In that case, it is not sufficient to designate end users only. It is the explicit intention that potential technology users and end users outside the immediate circle and outside the research field of the researchers submitting the proposal should be involved in the project from beginning to end. Users should be able to apply the knowledge generated by the research in the medium to long term. (Potential) users should be indicated in the utilisation section of the research proposal. In Part B the abovementioned industrial users can be involved in the user committee set up for the project.

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New ideas and talent development The research proposal must address the development of talent aimed at stimulating the theme’s research field. Part of the research budget (10%) must be devoted to this (see budget description for details in the ‘specific requirements’ sections).

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Foreign groups Foreign groups/institutes cannot supply a project leader/principal investigator (co-applicant). They can participate in the project providing expertise not presently available in the Netherlands. This could involve sending Dutch researchers abroad to gain expertise (with a guarantee of their return) or bringing foreign experts to the Netherlands. A maximum of 10% of the budget can be devoted to this.

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Extra work package without full financial cover It is possible to add an extra work package worth at most €100,000 that is not yet financially covered. This package has to be judged together with the complete proposal. Once the proposal is approved, joint (the applicant with DHF) funds can be raised. The applicant should state when this work package must start to become a meaningful part of the research proposal. This work package must start at the earliest one year after the start of the other work packages. Essential steps that can lead to important results of the project cannot be included in this extra work package.

Eligibility requirements for preproposals and full proposals The submission and evaluation process is broken down in two separate, subsequent stages: a call for preproposals followed by a call for full proposals. Eligibility requirements for submission The preproposals and the full proposals must satisfy at least the following eligibility requirements: • The research proposal must fit within the call theme: “Earlier recognition of cardiovascular diseases" as described above. The research proposal must contribute to achieving the long-term ambition. • The project duration must be no more than five years. •

To avoid double funding, proposals addressing the same research question and approach will be advised to jointly proceed toward a full proposal.

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The research described in the research proposal differs from ongoing (larger) research projects currently being financed by the Dutch Heart Foundation and STW.

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A research proposal must be jointly submitted by at least two researchers who are employed by at least two different public research institutes that are eligible for STW and DHF funding.

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Within this call, a researcher may associate his/her name as an applicant or co-applicant with only one research proposal. Exception clause The same person can act twice as principal investigator/co-applicant when his or her expertise is so exclusive that no other person/group in the Netherlands has this expertise. This exception clause can only be used if based on substantial argumentation. Pagina 11 van 62

The full proposal must also satisfy the following eligibility requirements: •

When requesting funding, part of the initial budget must be devoted to talent development aimed at stimulating the research field of the theme (see specific requirements Part A and B, sections: project specific costs).

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The proposal must explicitly address diversity aspects.

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The researchers must be prepared to share their data for the benefit of follow-up research (For part A specific rules are taken into account when IP is involved).

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Within each research programme, the potential impact of the project with respect to the aim of the theme should be evaluated. Part of the budget can be used for this.

Preproposals – Deadline 14 September 2015, 14.00 hours Preproposals consist of a short description (maximum of 5 pages) of the proposed research, the contribution to the aim of the programme, a utilisation section, and a breakdown of the estimated budget needed for carrying out the research. The necessary letters (position of applicant and coapplicant(s), collaboration) should be included. Proposals should be written in English with a minimum font size of 10 points. Preproposals should be written using the format described in Appendix 2.

Full proposals – Deadline 15 December 2015, 14.00 hours Full proposals must consist of a detailed description of the research plan, expected results, contribution to the aim of the programme, planning of the research and a utilisation section. The utilisation section should include the important clinical challenge(s) that will be solved, the timeframe to implementation and the expected bottlenecks during the implementation. The format for the full proposal will be available on the STW and DHF website within a few months.

Procedure The deadline for submitting a preproposal is 14:00 hours on 14 September 2015. The requirements that the preproposal must satisfy are given in this brochure. The STW and DHF offices will conduct the initial screening. The advisory committees (see details in the ‘specific requirements’ sections) will advise the STW and DHF offices. The advice about whether to submit a full proposal can be accompanied by required or suggested amendments to the proposal. The deadline for submitting a full proposal is 14:00 hours on 15 December 2015. The full proposals will be submitted to an international review process (see details in the ‘specific requirements’ sections). A presentation for the appropriate advisory committee is part of this process. The outcome of the administrative decision-making is expected in mid-April 2016. See the ‘specific requirements’ sections for the details of the procedure for each part of this call.

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Time schedule July 2015 Call for preproposals

Deadline 14:00 hours on 14 September 2015 Submission of preproposals

Check with national committee whether eligibility requirements have been met

16 October 2015 Advice from advisory and assessment committees. Formulate required or suggested amendments Notification of those invited to prepare a full proposal

Deadline 14:00 hours on 15 December 2015 Deadline for submitting full proposals

Check eligibility requirements have been met and whether required or suggested amendments to the preproposal have been made.

January-February 2016 Assessment by international referees

22 February 2016 Deadline for rebuttal

Evaluation by advisory committees

10 March 2016 Notification of those invited to present their full proposal

23 March – 1 April 2016 Presentations of selected proposals

Middle of April 2016 Decision by the boards of STW and DHF

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NWO Code of Conduct on Conflicts of Interest STW and DHF ask active researchers from research institutes and specialists from other knowledgeintensive organisations to participate in assessment procedures. These people are themselves involved in ongoing or new research and often belong to large organisational associations and research networks. Therefore, any conflict of interests, or anything that remotely resembles this, must be avoided in the assessment of research proposals. To ensure a fair assessment and transparency for applicants, STW and DHF use the NWO Code of Conduct on Conflicts of Interest. This code identifies possible forms of conflicts of interest and indicates the steps to be taken to avoid conflicts of interest. Parties subject to the code of conduct are: referees, jury members, committee members, members of decision-making bodies and STW and DHF officers. The full text of the code of conduct on conflicts of interest used by STW and DHF is available at: http://www.nwo.nl/en/documents/nwo/legal/nwo-code-of-conduct-on-conflicts-of-interest

Agreements The Partnership programme is a collaboration between STW and DHF. For any issues that might arise during the course of the project, the project leader can consult STW (part A) and DHF (part A and B) for advice. After granting, the applicant obtains a Partnership Project Agreement (for part A Appendix 3) or a consortium agreement (for part B Appendix 4) in which the legal and financial conditions are stated. The grant is available only after this agreement has been signed and returned to STW (part A) or DHF (part B) office.

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Contact information programme committee secretary Part A: Technology Foundation STW Dr Piet Lommerse Program Officer Phone: +31 30 600 1311 Email: [email protected]

Drs. Marjolein van Dalen Program Officer Phone: +31 30 600 1234 E-mail: [email protected]

Mr. Koen van Nol Legal Advisor Phone: +31 30 600 1317 Email: [email protected]

Part A and B: Dutch Heart Foundation Dr. ir. Karin Eizema Research Manager Phone: +31 70 315 5566 Email: [email protected]

Drs. E. Rennen Research Manager Phone: +31 70 315 5515 E-mail: [email protected]

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Specific requirements part A Selection procedure Committees involved: National committee: (only for the preproposal stage) To specifically assess the criteria: fit within the call theme, complementarity, the joining of national programmes and the leadership and research capabilities of the applicant and co-applicant, advice will be asked from a number of experts, independent national leaders of consortia and/or members of the working group involved in the writing of the report about the theme Earlier recognition of cardiovascular disease. The members of this committee are excluded from submitting a proposal for this call. Assessment committee: to guarantee the objectivity of the assessment as far as possible, a multidisciplinary assessment committee will issue an advice about which research proposals to fund. The assessment committee will have ten members (four people from ISAC-CVON*, one from the CMK**, and five independent experts in the field). The members are highly educated and/or experienced people with an affinity for technology development and/or cardiovascular research. Committee members are drawn from different sectors of society: universities, large research institutes, industry and other societal sectors. By using this approach, every assessment can take into account the societal needs that science and technology can address. *International Scientific Advisory Committee of CVON (ISAC-CVON). ISAC-CVON will advise the DHF CEO in all CVON procedures as to which research proposals should be funded and whether the funding of these should continue after the mid-term evaluation. **Committee Societal Quality (in Dutch: Commissie Maatschappelijke Kwaliteit (CMK): Starting in 2015 this committee consisting of members from different user groups (patients, specialists, general practitioners) will advise DHF about the societal quality of research proposals submitted for funding. For more information about the CMK please visit; https://www.hartstichting.nl/wetenschappers/cmk (in Dutch). Preproposals Preproposals for part A should be submitted electronically via Iris, STW’s electronic grant application system. To submit research applications and to obtain a copy of the Iris manual please visit https://iris.stw.nl. Upon receiving a preproposal STW and DHF will jointly determine whether the pre-proposal is eligible for consideration. STW and DHF will confirm receipt of the preproposal. They will then verify the formal requirements to determine whether the preproposal is eligible for consideration and has been submitted in the right part of the call. Within two working days after registration of the preproposal the main applicant will be informed about whether the preproposal is to be considered. If it is not to be considered, the main applicant will be given one week – calculated from the date of notification – to submit a revised version. The assessment committee will assess the strategic fit within the partnership programme and its topics and the other requirements based on the advice of STW, DHF and the national committee. Based on individual assessments by the committee members, the assessment committee will formulate an advice to the applicants, if necessary in a plenary session. The advice about whether to submit a full proposal can be accompanied by required or suggested amendments to the proposal. Pagina 16 van 62

Preselection If at least four times more full proposals are submitted than can be funded, STW and DHF retain the right to perform a preselection. Full proposals STW and DHF will confirm receipt of the full proposal. They will verify the formal requirements to determine whether the full proposal is eligible for consideration. If the relevant requirements are not fulfilled or the information requested is incomplete, the full proposal will not be considered. In that case, STW and DHF will return the full proposal to the main applicant with a request for adjustments or additional information. Within two working days after registration of the proposal, the main applicant will be informed about whether the research proposal is to be considered. If it is not to be considered, the main applicant will be given 15 working days – calculated from the date of notification – to submit a revised version. If the information required is not provided, or is incomplete by the 15 working days deadline, the full proposal will be recorded as withdrawn.

Assessment by referees STW and DHF will submit the full proposal to a number of national and international experts in the relevant specialist area (peer review). These referees are drawn from the scientific world, large research institutes, and industry. Referees remain anonymous. They assess the proposal on the basis of specific questions about scientific quality and utilisation. The questions that will be submitted to referees will be made available within a few months together with the notes for a full proposal. STW and DHF recommend that applicants anticipate these questions in the full proposal. The number of referees consulted by STW and DHF depends on the nature of the full proposal and the size of the budget contained in the full proposal. STW and DHF aim to have the full proposal assessed by three to five referees. Applicants may provide suggestions for referees when they submit their proposal. A list with the names and contact information of at most five independent referees with relevant expertise can be added to the application. The applicant(s) may ask STW and DHF to exclude up to two people or organisations from acting as referees. (Neither organisation uses a non-referee list). STW and DHF will grant this request only if the provision of information from the full proposal to that referee might obstruct the utilisation. STW and DHF will combine the individual referees’ comments, anonymised and if necessary paraphrased, into a ‘basis for a protocol’. Applicants’ rebuttal STW and DHF will send the ‘basis for a protocol’ to the main applicant with a request to respond to the referees’ comments. The main applicant will respond to each question or comment individually. The combined referees’ comments including the responses from the applicant(s) form the protocol that will be used by the assessment committee to reach their assessment.

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Assessment committee and decision-making Each assessment committee member assigns three scores of equal weight to each proposal, one for scientific quality, one for utilisation (prospects), and one for fit in the programme. The representative of the CMK may consult the other members of the CMK when making the assessment. The assessment committee makes its own consideration based on the protocol. Subsequently the proposals with the highest prioritisation are invited for an interview. During the interview, the committee has the opportunity to pose any questions it still has after reading the proposal, the external referees' reports and the rebuttal. The candidate can respond to these in the discussion with the committee. With this approach a hearing and rebuttal once again takes place. The interview is an important part of the selection process and may lead to a re-evaluation of the written proposal and the score awarded to it. Proposals can only be considered for funding if both the scientific quality criterion and the utilisation quality criterion together score no more than 7.0 and the individual criterions score no more than 4.0. The ‘notes on a full proposal’ will contain an appendix that explains the meaning of the quality scores. The STW board and DHF CEO largely base their joint allocation decisions on the prioritisation of the full proposals. The order established by the committee rankings is the starting point for this. A secondary consideration is the budget available. The STW board and DHF CEO do not assess the scientific content of the research proposals. In practice, unfortunately, the available budget will not be sufficient to fund every proposal of good quality. The STW board and DHF CEO may attach additional conditions to an award. These conditions may relate to matters such as intellectual property, co-funding by (potential) users, major investments and/or special infrastructure facilities.

Co-funding For each project, at least 15% of the STW/DHF funding required to conduct the research must be in the form of co-funding (in-kind and/or cash) from the users. For each project a minimal cash contribution from each private party is required that must be paid in two instalments (at start and 2 years after the start). The amount of the minimal required cash co-financing depends on the size of the company: - Start up: 2500 euros - SME (< 250 employees): 5000 euros - Large companies (> 250 employees) : 10000 euros Definitions 1. Total project costs: necessary financial resources plus in-kind contributions 2. Financial resources: Financial contributions used to cover part of the project costs together with the STW/DHF funding. 3. In-kind contributions: In-kind contributions means capitalised personnel and/or material contributions from users (see “Notes on Users, co-funding and letters of support” below for more information).

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After award A project agreement has to be signed when a grant is awarded. We explicitly advise you to carefully read the project agreement before submitting your proposal (Appendix 3).

Who can apply? Main and co-applicants On approval of the project, the main applicant becomes the project leader and bears ultimate responsibility for the realisation of the research including the utilisation plan. Co-applicants must play an active role (associate supervisor and/or daily supervision of researchers appointed to the project) in the realisation of the project and may be designated as sub-project leaders in the event of several participating research institutes. Who can act as main and co-applicants? Assistant, associate and full professors with a tenured position at: o Dutch universities (or with comparable positions at the university medical centres) o KNAW and NWO institutes o the Netherlands Cancer Institute (NKI) o the Max Planck Institute for Psycholinguistics in Nijmegen o Dubble beamline at the ESFR in Grenoble o NCB Naturalis o Advanced Research Centre for NanoLithography (ARCNL) Researchers with a tenure-track appointment. STW defines a tenure-track appointment as an appointment for experienced scientific researchers with prospects of permanent employment and a professorship in due course. The tenure-track appointment must be confirmed in writing and funded from structural resources. STW will verify that the appointment meets these conditions and that it is guaranteed for the term of the project. Participation HBO, RIVM and TNO Personnel of HBO institutions, RIVM and TNO who participate in the project can be reimbursed according to the rates in “Akkoord overlaten werkgeverschap NWO/VSNU”. The total reimbursement has a maximum of 50% of the financial section of the budget. Main and co-applicants with a part-time appointment • •

Main applicants and co-applicants employed on a part-time basis should in any case have access to sufficient university facilities and budget to carry out the project properly. Main applicants and co-applicants should carry out STW research while they are working for the research institute. If this is not the case, the other employer should sign a waiver so as to guarantee knowledge ownership by STW and the research institute(s).

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Who cannot apply? (Applies to main and co-applicants) • • • •

• •

Personnel with a zero-hour appointment Personnel with a temporary employment contract (e.g. postdocs) Emeritus professors Personnel of institutes with an applied or technological objective, such as the Large Technological Institutes (GTIs) and the non-university part of the Wageningen University and Research Centre (WUR) Personnel of a research institute funded by a public-private targeted grant Personnel of foreign research institutes

Guidelines for applicants Below more information about Project specific costs and Users, Co-funding and Letters of Support

Project-specific costs STW funds project-specific costs of: 1. personnel temporarily appointed to the project at the research institute 2. materials (consumables, small instruments and aids, and domestic travel expenses, part of the talent programme), 3. foreign travel (part of the talent programme), 4. equipment (durable scientific equipment in respect of which economic value is depreciated). The institution(s) of the applicant(s) ensure(s) the required infrastructure, the supervision, alignment with and embedding within the research program of the research institute. The expertise required for the research must be available at the requesting institute(s), so that external consultants will not be necessary. STW and DHF may verify this with the dean or the executive board of the institute. The research institute is responsible for co-funding from direct government funding and hence for the necessary infrastructure and the supervision of project workers. If an applicant/co-applicant cooperates with other institutes not eligible for STW funding, such as a foreign university, the non-eligible institutes are responsible for their own costs.

Notes on costs of personnel temporarily appointed to the project at the research institute Temporary personnel positions can be requested for: • PhD student • postdoc (PD) • PDEng trainee • other SP (scientific personnel, including additional researcher, holders of a masters degree, medical graduates) • NSP (non-scientific personnel, including technical assistant) • Casimir candidate

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Notes on temporary personnel positions Temporary personnel positions can be requested for up to four years in the case of a full-time appointment. State the job group, the length of the appointment, the part-time percentage and the associated amount. For each position, STW uses a predetermined fixed maximum rate per year of appointment (see www.stw.nl). In determining these rates, STW adopts the rates laid down in the most recent ‘akkoord overlaten werkgeverschap NWO/VSNU’, with no supplement for the risk of unemployment. Under this agreement, the personnel rates for the positions are determined annually after agreement on the long-range forecast for personnel rates. The rates which apply at the time of award are maintained for the duration of the STW project. If the personnel rates are changed during the evaluation procedure, STW will apply the new rates at the time of award. This does not affect the level of the compulsory contribution from users. Personnel appointed to additional personnel positions during the course of the project (e.g. in the event of continuation or extension) are subject to the rates which apply at that time. For postdoc, scientific personnel and non-scientific personnel positions, STW does not accept liability under the Dutch Unemployment Insurance Act if the term of appointment is less than 12 months and/or the candidate has more than 1 year’s relevant work experience in a previous, similar appointment. The research institute appoints the personnel and bears the customary responsibilities of an employer. Notes on permanent staff The salary or allowance paid to the applicant/co-applicant and the salary or allowance paid to others person with a permanent appointment or other permanent association with the institute where the research is to take place are not eligible for reimbursement. Exceptions to this are the temporary appointment to a project of 1) a technical assistant (NSP) or 2) a scientist with an ‘appointment on a project basis’. An NSP with an existing employment contract at the research institute can temporarily be appointed against the standard NSP rates at the expense of an STW project, if this NSP has a specific special expertise that is necessary for realising the research proposed. A scientist with an ‘appointment on a project basis’ at the research institute can temporarily be appointed against the standard scientific personnel rates at the expense of an STW project. The scientist concerned may not be registered as an applicant or co-applicant at STW/NWO. STW accepts no liability under the Dutch Unemployment Insurance Act in this case. Notes on secondment Temporary researchers are appointed to the research institute where the research is to be realised. Because STW imposes the condition that the majority of knowledge development must take place at the research institute, the secondment of university researchers to a company or other research institute is permitted only for a limited period, i.e. up to 50% of the extent of the appointment. This requires written permission from STW in advance. A secondment agreement shall be concluded. Where the need arises, an applicant can submit a reasoned request to the STW office to grant leniency with regard to the 50% limit. Criteria for this are 1) there must be a need to use the infrastructure of the external party, 2) there must be a sufficient academic environment present at the external party for interaction with and supervision of the researcher and 3) the project leader and/or supervisor of the researcher must also be present at the external location concerned for some of their time. Pagina 21 van 62

Notes on PDEng trainee A temporary personnel position can be requested for a PDEng trainee (certified training Professional Doctorate in Engineering). This position should be applied for within a larger research context (1 or more other scientific personnel positions). The PDEng trainee is employed by the institute submitting the application and for a fixed period of time can perform certain tasks within the research project at a company (on a secondment basis). The PDEng position is subject to the following conditions: • In the research plan and the utilisation section the embedding of the PDEng position should be described and/or the underlying Technological Designer Programme. • Assuming a full-time appointment, a maximum duration of 2 years applies. • The personnel rate for a PhD (first 24 months) applies to a PDEng position. The personnel costs are included in the personnel credit. • For the PDEng position, material and/or travel credit can be applied for as part of the standard credit. • The secondment to the company concerned is for a maximum of 50% of the duration of the appointment. • The contribution from the company concerned to the PDEng position is k€ 50 (assuming 1 fte for 24 months). This contribution should be entered in the project budget as cash co-financing to be settled with STW. • If the project is funded then a secondment agreement must be signed with the company concerned. Notes on Casimir candidate One SP position can be filled by an academically trained R&D worker from a Dutch company or a company with a Dutch branch where R&D activities are carried out (100% private sector). The following conditions apply: • Based on a full-time secondment, a 2-year time limit applies. The limit for PhD students is 3 years. Part-time secondment (at least 50%) is possible. • The proposed candidate should have been working for the above-mentioned private sector employer for at least 1 year (tenured or temporary appointment). • The application should contain a brief description of the proposed candidate’s work experience and expertise. On the basis of the necessary work experience of the relevant candidate, PhD work should be able to be completed within 3 man-years. • In addition to the Casimir position, at least 1 other SP position must be requested with at least the same extent of appointment. • The Casimir candidate should have access to the university infrastructure and the Casimir position should be an integral and necessary part of the proposed university research and serves the realisation of the project aims and utilisation. This should be described in the research plan. • In relation to personnel costs for the Casimir position, the university can declare to STW the secondment costs actually paid to the company, up to the personnel rate for a postdoc position which applies for the relevant extent of appointment. These costs should be charged to the material credit for the project. STW accepts no liability under the Dutch Unemployment Insurance Act for the Casimir candidate. • Material and/or travel credit can be requested for the Casimir candidate as part of the regular credit to be requested. • If the project is funded then a secondment agreement must be signed with the company concerned. Pagina 22 van 62

Notes on costs of materials and domestic travel • •

STW funds consumables, small instruments and aids, and domestic travel expenses. The amounts stated in the budget are exclusive of Dutch VAT.

Notes on Material credit Costs which CAN be charged to material credit • Materials which no longer have an economic value after use. This concerns consumables, small instruments and aids. • Specified compound items. Fixed instalments or rates in particular (e.g. bench fees and fees for standard analyses) must be substantiated. Within the rates accepted by STW, only the consumables costs can be charged to STW. • Personnel costs for Casimir position (see point 8.1 for notes). • Costs of domestic travel. • Costs of project-specific courses for STW researchers which are necessary for the conduct of the research. • Posters for disseminating knowledge at conferences and symposia. • Pre-clinical trials. A condition in this respect is that the project workers themselves are responsible for the majority of the work (e.g. sampling, analyses). • Costs for the use of cleanrooms insofar as these fall under the cleanroom regulation (see www.stw.nl ). Costs which CANNOT be charged to material credit • ‘Miscellaneous’ or ‘unforeseen’ items, unspecified bench fees. • Patent costs. Where appropriate, STW will consider the extent to which it will bear such costs. • Costs of publications or costs of purchasing books and/or journals. • Costs of publications or books. • Costs of printing a thesis. A separate reimbursement scheme exists for this (see www.stw.nl). • Costs of general courses which form part of researchers’ generic education and the generic education of a PhD student (e.g. English, presentation skills, literature searching, laboratory animal science, use of isotopes). • Costs of desktop computer, laptops, notebooks or similar for administrative purposes (text and data processing) and costs for computer use. • Generic software. STW assumes that generic software is available via campus licences. • Costs associated with the use of computing facilities at SURFsara. If necessary, these costs can be requested from the Netherlands eScience Center (NLeSC) in Amsterdam. • Costs of using existing infrastructure (depreciation charges), salary costs of permanent personnel, accommodation costs, overheads and administrative and technical support, where these are part of the research institute’s customary package of facilities. • Costs (excluding material costs and cleanroom regulation) of university facilities (e.g. glasshouse space, laboratory animal facilities, specialist research facilities). • Clinical trials.

Notes on costs of foreign travel The foreign travel credit is intended to cover costs associated with participation in conferences and symposia in other countries. Extended visits may also be applied for. Pagina 23 van 62

Notes on short travel abroad For temporary project workers, STW applies a maximum standard amount (2000 euro/year/fte) which can be claimed as short travel abroad. Foreign travel costs of applicants and co-applicants can also be claimed up to the maximum standard amounts, provided those costs are directly related to the conduct of the proposed research and a convincing argument is put forward in this respect. In principle, travel costs cannot be claimed for non-scientific personnel (NSP). If the sum claimed exceeds the maximum standard amount per year it cannot be accepted unless clear arguments are put forward on which STW and the referees can base their verdict. Notes on exchange visits Temporarily appointed project workers may carry out research at a foreign research institute for a limited period (up to six months) in the context of an STW project. A foreign researcher may also be temporarily appointed to an STW project; he or she visits the research institute and participates actively in the conduct of the project. Conditions relating to foreign travel of up to six months’ duration: • STW must be aware of this type of foreign travel when considering the application, and it must form part of the research planning so that referees can include it in their review. • A condition for an exchange is that the knowledge acquired as a result of the visit is not present, or is not sufficiently available, at the research institute where the research is being conducted. In the event of acceptance, STW verifies whether this actually results in a strengthening of the knowledge base for the project. • STW reimburses the travel expenses, research costs and a standard amount for accommodation expenses. No (additional) salary costs are reimbursed. For the list of standard amounts for accommodation costs, see www.stw.nl. • Any intellectual property matters are covered by a separate agreement (waiver/confidentiality) before travel takes place.

Notes on costs of investments Investments are defined as the use of durable scientific equipment in respect of which economic value is depreciated. Investment costs are entered in the budget exclusive of Dutch VAT. Notes on investments •

• • • •

The equipment is and remains the property of STW. After the end of the project the equipment remains at the research institute. Formal transfer of ownership of the equipment without further payment is possible. A time limit of five years after purchase is applied in this respect. STW assumes that the research institute applies a tendering procedure for the purchase of durable equipment and takes account of government procurement guidelines. If second-hand equipment is purchased, the original bill must be submitted. STW may be asked to co-fund an item of equipment in proportion to its use. This should be put down in writing after the award. The research institute is responsible for the connection, operating costs and maintenance of the equipment purchased (service charges and repairs).

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•

• • • •

STW distinguishes between operation of existing facilities within the research institute and investment in new facilities specifically for the purposes of an STW project. In the case of operating costs and small-scale investments, STW pays only the costs of consumables. These costs can be claimed as material credit. STW will however pay the full cost of capital goods supplied by internal services in those cases where a disproportionate burden is placed on the service in question, provided that a convincing argument is put forward in this respect. STW will be the judge of this. Computers belonging to scientific equipment and specific software used exclusively for the project may be claimed as investment. Computing capacity which demonstrably exceeds the normal capacity required for the research in question can be claimed as investment. If, in the course of time, it emerges that the costs of the investments described in the proposal are lower than estimated, the remaining funds will revert to STW. STW may refuse expenditure not estimated in advance.

Notes on Users, co-funding and letters of support Users Users of research are defined as natural or legal persons (at national or international level) who are able to apply the results of the research. A distinction is sometimes drawn between direct users of the knowledge generated, usually companies, and end users, who buy the products from those companies. Both have a role to play in the innovation chain and must be referred to in the utilisation plan. Research proposals from a medical faculty or university medical centre should have potential users, just like other proposals. At least one of the users should be a company. It is not sufficient in this case to state merely ‘the patient’ or ‘a clinic’. The final composition of the user committee is subject to the same conditions as other STW projects. User committees STW and DHF ensures that the knowledge generated by the research is practically and effectively transferred to users by consulting with the project leader of each research project to set up a user committee on the basis of the users proposed in the project plan. User committee meetings are attended by the applicants/co-applicants, project/subproject leaders, the researchers temporarily appointed to the project, representatives from STW and DHF, and if applicable special invited experts and the representatives of potential users. DHF will appoint (in close consultation of the project leader) one member of the users' committee. The project leader acts as chairman and STW runs the secretariat. A minimum of four users should sit on the user committee and at least 50% of them should be from industry. During the course of a research project, STW and DHF may change the composition of the user committee if there are grounds for doing so; such changes will always be made with the approval of the project leader. In doing so, STW will make due allowance for the advice of the sitting users and the level of their pledged co-funding. The guiding principle will be to ensure that the composition of the user committee maximises the likelihood of the results being applied and that the interchange of ideas, including confidential information, remains possible. The committee can advise the project leader on the direction the research should take in order to promote the application of the results. The project leader always holds ultimate responsibility for the

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realisation of the research in accordance with the approved project plan. The instructions for participants in a user committee are included in the ‘General Conditions’ (see: www.stw.nl). The members of the user committee are formally invited by STW to sit on the user committee. Those participating in the user committee commit themselves to the conditions included in the ‘General Conditions’. Notes on Criteria relating to co-funding •

•

• • •

•

STW uses the financial co-funding to cover part of the project costs. After a project is approved, STW sends an invoice to users who have pledged a financial contribution. Once the funds have been received, they are allocated to the project. STW accepts personnel input and material contributions as co-funding on the condition that these are capitalised and that they form an integral part of the project. This should be made clear in the description and planning/phasing of the research. STW and DHF are the main funders of the projects. Project applications where the co-funding from users exceeds the amount to be borne by STW/DHF will not be considered. STW assumes that providers of co-funding have an interest as users and therefore as appliers of the research results outside science. Co-funders always participate in the user committee. Government agencies can play various roles in STW projects, namely: (1) as a research partner (without entitlement to STW funding), (2) as a subcontractor of a specific assignment (at market rate) or (3) as a user. Government agencies may act as users under the same conditions as private users. The co-funding to be provided by users must be confirmed in a letter of support. These letters must explicitly state: 1) the importance of the research proposal for the organisation, 2) the importance of the utilisation plan for the organisation’s operations, 3) the pledged financial and/or the specified capitalised material and/or personnel contribution(s) and 4) whether the user intends (i) to commit to the IP and publication arrangements as laid down in the Partnership Project Agreement (ii) to make its own arrangements with the knowledge institution(s), Dutch Heart Foundation and user(s) concerned. In the pre-proposal the intended options needs to be marked. See also the requirements under ‘Letters of support’ and the ‘Notes on Intellectual Property policy (IP policy) & Publication arrangements’ later in this brochure.

Notes on Criteria relating to in-kind co-funding •

• •

Part of the research may be conducted by third parties. A condition is that the expertise provided in the form of man-hours is not already available at the research institute(s) and is used specifically for the STW project. For personnel support by third parties, STW applies fixed rates in order to capitalise the number of man-hours used (up to 1250 direct hours/year/fte) for a senior or junior researcher. For the current rates, see www.stw.nl. For pledges of material resources, charge the cost price. Commercial rates are not accepted. For pledges of equipment, take previous depreciation and intensity of use into account. Pledges in the form of supplies of services are possible only if the service can be itemised as an identifiable new endeavour. The service should not already be available at the research institute(s) realising the research. Applicants may wish to claim services already supplied (such as a database or software) as in-kind co-funding. Acceptance is not automatic in such cases. Contact STW about this. Further consultations will take place to decide whether a specific value can be determined for this supply of services.

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NOT permissible as co-funding •

• • •

• •

STW guards against the improper mixing of funding sources: co-funding can never come from direct or indirect (NWO, KNAW) government funding. As a result, co-funding can also never come from the research institute of the (co-) applicant(s) or from institutes which are themselves eligible to apply to STW. Discounts on (commercial) rates for materials, equipment and/or services, for example. Costs relating to overheads, supervision, consultancy and/or participation in the user committee. Costs of services that are conditional. No conditions may be imposed on the provision of cofunding. Nor may the provision of co-funding be contingent upon reaching a certain stage in the research plan (e.g. go/no-go moment). Costs which are not paid by STW (e.g. clinical trials, costs relating to the exploitation of the research results, service costs equipment). Costs of equipment if one of the (main) aims of the research proposal is to improve this equipment or to create added value for it.

Letters of support A letter of support is obligatory if co-funding is provided by the users. STW advises applicants to ensure that the users pay particular attention to endorsing the importance of the utilisation plan for their operations. The letter of support should satisfy the following requirements. A. General requirements • Letters of support must be printed on the letter paper of the co-funder. • Letters of support are addressed to the project leader with a copy to STW. • Letters of support must be written in English. • The address on the letter is correct. • Letters of support must be signed by an authorised signatory. • The cash contribution stated in the letter is paid to STW. B. Specific requirements • Brief description of the company and the core business (type of company, size, which service, products). • A statement that the company is interested in and will commit itself to the research. • An explanation as to why the answering of the research question is important to the company. How does this solution fit in their strategy? • A brief explanation as to why this particular research group and research proposal are receiving support. • What the company will contribute in concrete terms (incl. capitalisation) and why this fits in the research proposal/planning. • Further specification of the in-kind support, both hours (number and/or tariff applied) and materials (numbers; cost price; tariff; percentage that can be attributed to the project, etc.). • The company provides the contribution described without additional conditions.

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C. Declaration and signing by the User • The company states that it has read the proposal and signs for this. • The company states that it will actively participate in the User Committee (UC) and signs for this. • The company states that it agrees to the Partnership Project Agreement and signs for this. Optional: The company states, and signs accordingly, that - contrary to the provisions of Part 3 of the General Conditions and the Partnership Project Agreement - it will make its own IP arrangements with all knowledge institution(s), Dutch Heart Foundation and user(s) and concerned.

Letters of support are unconditional and do not contain any opt-out clauses. The amounts stated in the letters of support must correspond with the amounts stated in the budget presented. A copy or scan of the letter will suffice for the submission of a full proposal. STW will not approach persons or organisations who have signed letters of support to act as referees (code of conduct on conflicts of interest). After the research proposal has been granted STW will request a confirmation of the co-funding (“confirmation obligation third parties”) and in relevant cases will record any further arrangements in an agreement.

Notes on Intellectual Property Policy & Publication arrangements STW and DHF facilitate the transfer of knowledge between the technical sciences and users. In this process it is important that a responsible approach is taken with regard to research results in general, and patentable inventions and discoveries in particular. STW and DHF aim to exploit and publish the results of research as widely as possible, whilst retaining the possibility to establish IP rights and to subsequently commercialise these rights and, secondly, to stimulate collaboration between researchers and various external companies. STW and Dutch Heart Foundation adhere to a set of rules concerning Intellectual Property (IP) that supports this mission. This policy is in line with the IP policy adopted by the Netherlands Organisation for Scientific Research [Nederlandse Organisatie voor Wetenschappelijk Onderzoek, NWO] and with the ‘Rules of Play for public-private collaboration’ as presented to the Lower House of the Dutch Parliament on 25 June 2013. STW and Dutch Heart Foundation will also offer knowledge institutions the opportunity to make their own IP and Publication (IP&P) arrangements with the parties with which they cooperate. In this way, they hope to respond better to the wishes of the researchers and co-funders who are involved in the Partnership Program and underlaying projects. It will continue to be possible to opt for the approach whereby the existing arrangements for IP and similar matters; in such cases, the intellectual Property policy as laid down in the Partnership Project Agreement will be followed. If knowledge institutions prefer to make their own arrangements, they must make this known - with the approval of the Dutch Heart Foundation and companies concerned - at the time the application is submitted, and have concluded the arrangements within three (3) months of receiving STW's approval for the project. The knowledge institution has the lead in these circumstances. The arrangements will subsequently be reviewed by STW to ensure they are compatible with five criteria that reflect the task and mission of STW. STW and DHF asks the party submitting the research proposal to indicate, in advance (a mark in the preproposal form) which option has been chosen with regard to IP&P arrangements for the results of the research. The actual approval needs to be confirmed when submitting the full proposal). The two options and the attendant implementing conditions are described in the table below. Pagina 28 van 62

Option 1 STW takes the lead in making Intellectual Property and Publication arrangements ('STW IP&P arrangements')

Option 2 Knowledge institution takes the lead in making Intellectual Property and Publication arrangements ('Own IP&P arrangements')

Part 3 of STW's 'General Conditions' on 'Intellectual Property & Publication' is applicable.

'Own IP&P arrangements' fulfil the following criteria: -

Access to foreground IP rights for private party or parties / consortium: -

-

-

-

-

0-10% private contribution private party or parties: private party/parties have no automatic right 11-30% private contribution private party or parties: private party, parties or consortia have right of option 31-50% private contribution private party or parties: non-exclusive non-transferable commercial licence + right of option to exclusive right. Contribution towards patent costs can be required Private parties can combine their contributions so as to achieve a more favourable ranking Confidential information remains confidential Results can always be published but publication may be suspended for a maximum of 9 months in connection with the protection (patent) of the results

Agreements must be confirmed in writing within six months of the project being awarded

Further information on Options 1 and 2 can be found in STW's 'General Conditions' and in the relevant/underlying 'Guidelines for financing applications'

-

-

All necessary foreground information (IP ensuing from the STW project) and - insofar as legally possible background information (already existing IP from company and/or knowledge institution) is available for the execution of the project The agreement is aimed at the application or allocation of the results by way of publication Publication of scientific knowledge from the project will not be obstructed by users, but the beneficiary and users may determine the publication schedule Any results generated from the project by the beneficiary remain available for the beneficiary for educational and research purposes

On submission: The knowledge institution(s) and all users agree that the provisions under 'Own IP&P arrangements' will apply to the STW project and declare that they do or will satisfy the criteria from i to iv above After award: The knowledge institution(s) and all users approve the agreement in writing STW will receive, no later than three (3) months after awarding the project: - The signed agreement in which IP&P arrangements are made with the user(s) - A signed IP&P statement in which the knowledge institution declares that the agreement relating to the IP&P arrangements with the user(s) satisfies all the pre-determined criteria. The knowledge institution hereby refers to the relevant provisions in the agreement STW reviews the agreement against the pre-determined criteria; if STW approves the agreement, STW informs the project leader - in accordance with Article 2 (4) of STW's 'General Conditions' - that the project can be started.

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Notes on Option 1: when STW makes Intellectual Property & Publication arrangements STW takes the lead on the subject of IP&P arrangements. Once a project has been approved, all users that contribute to the project receive a letter from STW informing them that the project has been awarded to the knowledge institution. In addition, STW asks the user to sign the letter to (re)confirm its participation in and contribution to the project, and all involved parties will sign the Partnership Project Agreement. Notes on Option 2: when own Intellectual Property & Publication arrangements are made If the knowledge institution elects to make its own arrangements with the user for Intellectual Property rights and Publication, those arrangements must be set out in writing. They must also satisfy the following conditions: i. All necessary foreground information (IP ensuing from the STW project) and - insofar as legally possible - background information (already existing IP from company and/or knowledge institution) is available for the execution of the project; ii. The agreement is aimed at the application or sharing of the results by way of publication; iii. Publication of scientific knowledge from the project will not be obstructed by users, but beneficiaries and users may determine the publication schedule; iv. Any results generated from the project by the beneficiary remain available for the beneficiary for educational and research purposes. Furthermore, the following conditions apply on submission or on award of a project: •On submission: the knowledge institution(s) and all users agree that the provisions under 'Own IP&P arrangements' will apply to the STW project and declare that they do or will satisfy the criteria from i to iv above. •After award: The knowledge institution(s) and all users approve the agreement in writing. Within three (3) months of the award of the project, the applicant knowledge institution will submit a copy of the agreement to STW, indicating where arrangements for each of the specified conditions can be found. Within three (3) months of the award of the project, all knowledge institutions, Dutch Heart Foundation and users concerned will also declare that all the conditions have been satisfied; this will be done by signing and returning the appropriate form. If, on review, it transpires that the arrangements made do not satisfy the conditions set out above, STW can extend the original three (3) month period after award by a further period of up to two (2) months, to enable the user(s) and the knowledge institutions to modify the arrangements so that they do satisfy the pre-determined conditions. If at the end of this period the conditions have not been satisfied, this means that the conditions attached to the award have not been fulfilled and there can be no allocation of funding.

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Specific requirements part B Selection procedure Committees involved: National committee: (only for the preproposal stage) To specifically assess the criteria: fit within the call theme, complementarity, the joining of national programmes and the leadership and research capabilities of the applicant and co-applicant, advice will be asked from a number of experts, independent national leaders of consortia and/or members of the working group involved in the writing of the report about the theme Earlier detection of cardiovascular disease. The members of this committee are excluded from submitting a proposal for this call. International Scientific Advisory Committee of CVON (ISAC-CVON). ISAC-CVON will advise the CEO of the DHF in all CVON procedures as to which research proposals should be financed and whether the funding of these should continue after the mid-term evaluation. Committee Societal Quality (in Dutch: Commissie Maatschappelijke Kwaliteit (CMK): Starting in 2015 this committee consisting of members from different user groups (patients, specialists, general practitioners) will advise DHF about the societal quality of research proposals submitted for funding. The CMK discusses its evaluation with the ISAC-CVON. Subsequently, a joint recommendation is presented to the CEO of the DHF. For more information about the CMK please visit; https://www.hartstichting.nl/wetenschappers/cmk (in Dutch). Preproposals Preproposals for part B should be submitted via email to [email protected] Upon receiving a preproposal DHF will determine whether the preproposal is eligible for consideration. DHF will confirm receipt of the preproposal. It will then verify the formal requirements to determine whether the preproposal is eligible for consideration and has been submitted in the right part of the call. Within two working days after registration of the preproposal the main applicant will be informed about whether the preproposal is to be considered. If it is not to be considered, the main applicant will be given one week – calculated from the date of notification – to submit a revised version. ISAC-CVON will assess the strategic fit within the programme and its topics and the other requirements based on the advice of DHF and the national committee. Based on individual assessments by the committee members, ISAC-CVON will formulate an advice to the applicants, if necessary in a plenary session. The advice about whether to submit a full proposal can be accompanied by required or suggested amendments to the proposal. Preselection If at least four times more full proposals are submitted than can be funded, DHF retains the right to perform a preselection. Full proposals DHF will confirm receipt of the full proposal. It will verify the formal requirements to determine whether the full proposal is eligible for consideration. If the relevant requirements are not fulfilled or the information requested is incomplete, the full proposal will not be considered. In that case, DHF will return the full proposal to the main applicant with a request for adjustments or additional information. Within two working days after registration of the proposal, the main applicant will be informed about Pagina 31 van 62

whether the research proposal is to be considered. If it is not to be considered, the main applicant will be given 15 working days – calculated from the date of notification – to submit a revised version. If the information required is not provided, or is incomplete by the 15 working days deadline, the full proposal will be recorded as withdrawn. Assessment by referees DHF will submit the full proposal to a number of international experts in the relevant specialist area (peer review). These referees are drawn from the scientific world, large research institutes, and industry. Referees remain anonymous. They assess the proposal on the basis of specific questions about scientific quality and utilisation. The questions that will be submitted to referees will be made available within a few months together with the notes for a full proposal. DHF recommends that applicants anticipate these questions in the full proposal. The number of referees consulted depends on the nature of the full proposal and the size of the budget contained in the full proposal. DHF aims to have the full proposal assessed by three to five referees. Applicants may provide suggestions for referees when they submit their proposal. A list with the names and contact information of at most five independent referees with relevant expertise can be added to the application The applicant(s) may ask DHF to exclude up to two people or organisations from acting as referees. (DHF does not use a non-referee list). DHF will grant this request only if the provision of information from the full proposal to that referee might obstruct the utilisation. DHF combines the individual referees’ comments, anonymised and if necessary paraphrased, into a ‘basis for a protocol’. Applicants’ rebuttal DHF will send the ‘basis for a protocol’ to the main applicant with a request to respond to the referees’ comments. The main applicant will respond to each question or comment individually. The combined referees’ comments including the responses from the applicant(s) form the protocol that will be used by the assessment committee and ISAC-CVON members to reach their assessment.

ISAC-CVON decision-making No more than two times the number of proposals that can be funded will be selected for an interview. This selection will be done based on an advice from the ISAC-CVON using the available written information and applying the CVON selection criteria (see below). After ranking the proposals the ISAC-CVON will deliberate with the chair of the ISAC-CVON which proposals will be invited for the selection meetings. The selected proposals have to be presented to the CMK and to the ISAC-CVON (two separate meetings, one or two days apart). The applicants will receive an invitation for the interviews at least two weeks before the selection meetings.

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ISAC-CVON will consider several other aspects besides the scientific quality of the research proposal, including: •

A clear and evident relationship between the healthcare problem ‘Earlier recognition of cardiovascular diseases’ as described in this brochure and the scientific question;

•

The description and cohesion of the programme and the described translational pathway of the research;

•

The leadership qualities of the project leader. In ISAC-CVON's view, this can best be evaluated during the oral presentation of the research proposal to ISAC-CVON and the subsequent discussion.

CMK assesses the societal quality of the research proposal. This committee consists of patients, healthcare professionals (GP, nurses and specialists) and other societal stakeholders. The committee's aim is to advise DHF about the societal quality of the research proposals and to stimulate, facilitate and advise researchers to increase the societal impact of their research. The attention paid to societal quality as a precursor for the societal impact of the research must be clearly demonstrable in the proposal. Prior to the ISAC-CVON meeting, a presentation is held for the CMK, including an interview. During the interview, the committee discusses the following questions: •

How and to what extent contributes the research to solving the specified healthcare problem in the short and/or long term?

•

Does the proposal clearly describe how and to what extent the researchers will actively engage in transmitting knowledge, and not only to immediate colleagues, but also to scientists who could take the next step in the research or its implementation, or to professionals (in the broad sense) who could start working with the research results (Next Step)?

•

To what extent is the specific knowledge of professionals and patients incorporated?

In order to discuss its judgement with ISAC-CVON, two members of the CMK will join the meeting of the ISAC-CVON. Then a joint recommendation is sent to the DHF CEO. The DHF CEO largely bases its allocation decisions on the prioritisation of the full proposals. The order established by the ISAC-CVON rankings is the starting point for this. A secondary consideration is the budget available. The CEO does not assess the scientific content of the research proposals. In practice, unfortunately, the available budget will not be sufficient to fund every proposal of good quality. The CEO may attach additional conditions to an award. These conditions may relate to matters such as intellectual property, co-funding by (potential) users, major investments and/or special infrastructure facilities. Complaints procedure An applicant can submit a complaint about problems with the procedure by completing a form that is sent to the Complaints Committee of DHF. It is not possible to appeal against the outcome of the procedure. The form can be found on DHF website. Complaints should be submitted within four weeks after receiving the notice from the CEO of DHF.

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Who can apply? See general information, no additional requirements.

Description of full proposals Format The proposal should not exceed the indicated number of pages in A4 format (minimum Arial 10 point or similar font), excluding budget, curriculum vitae and appendices. The application should be in English. The information entered should be complete and correct. Incomplete forms or forms that exceed the maximum permitted length may lead to your application not being considered. The format for the full proposal will be available on the DHF website within a few months. When formulating the full proposal, the focus lies on the healthcare problem “Earlier recognition of cardiovascular diseases", studying the underlying mechanisms (fundamental, clinical, epidemiological), and the potential impact of the project must be supported (with figures and literature references). It is important that the research proposal forms a cohesive project. Research proposals should pay attention to the translation of findings. A number of aspects are described below that must be addressed in the research proposal: Healthcare Which cardiovascular care problem (suitable for this theme) must be solved and how (and to what extent) does this research contribute to that end? Science Which scientific problem is being solved? quality Research project leaders and principal investigators are authorities in the relevant research field (see definitions of research leaders and principal investigators). innovative Innovative character of the research proposal according to international criteria, for example the introduction of new technologies, new disciplines and/or new concepts. interaction Collaboration between researchers from different fields and users (e.g. the general public, primary care practitioners, hospital workers, specialists). work plan Clear proposal, in terms of hypothesis, question, methods, expected results, budget, etc., specifying which contribution is made by the participating institutes/research groups in terms of personnel, infrastructure and material means. If subsidising of infrastructure and/or specific knowledge and skills is desired, this should be clearly described. Points of attention •

•

Clearly state in the description of your research design how you intend – if it is sensible and feasible - to take diversity into account (age, gender, ethnicity). For example, consider patient inclusion, selection of models (animal), statistical analyses, etc. If this does not apply to your proposal then you must justify the reason for this. Essential steps that can lead to important results of the project must not be included in the still unfinanced work package (or part of one). Pagina 34 van 62

NB: the burden of proof always lies with the applicant; assertions must be well supported.

Project-specific costs Two remarks: 1. The amount requested must follow logically from the description of the work in the proposal. In the description a substantiation of the costs in text must be presented. 2. The whole consortium needs to use equal salaries for personnel. E.g. every institute uses the same amount for a PhD student for 4 years. An integral estimate of the budget is needed per work package as well as ‘overall’. There is a distinction between: a) In cash (DHF): This is what you request from DHF. b) In kind (contribution own institute): the amount the participating institutes contribute. This must be substantial but also realistic. If the proposal is granted then these contributions need to be confirmed in writing. c) Extra work package without full financial cover: o Extra work package: Use a separate sheet for this work package. o Part of a work package: Include the budget of this extra part into the sheet of the work package in question. The overall integral budget needs to be copied in the proposal as a table. The fundable categories: 1. Personnel Only salary costs (gross annual salary + social contributions + holiday pay + end-of-year bonus) according to the VSNU-salary scales (see www.vsnu.nl) can be requested. Other costs like materials or courses should be written at the part ‘other parts’ or the part ‘development of (young) talent’. 2. Other costs a) other costs: all other costs which do not fit in the items below b) animals: all costs, buying, housing and costs for experiments c) infrastructure: usage of equipment or buying new equipment. Also depreciation of new equipment. The costs of the maintenance of equipment is for the institute. 3. Subcontracting Companies or institutes who deliver a service for the consortium. One price needs to be given for the employment of the service (employment of personnel and/or material (incl. VAT)). A description in words is also needed in the work package(s) 4. Consortium management Consortium management is the financial and administrative coordination of the project under supervision of the project leader. The costs are to be described in the proposal. 5. Development of (young) talent Part of the budget (10%) needs to be reserved to give new ideas a change and to develop (young) talent. In the proposal a clear description of this 10% needs to be given. We would like to state that the spending of this budget needs to go beyond yearly meetings, following courses or foreign travel. The positioning of talent towards European grants can also be an important part of this programme. Any other activity is possible when clearly described how this will stimulate talent. Pagina 35 van 62

This part is considered a separate work package with a designated ‘principal investigator’.

Users Users of research are defined as natural or legal persons (at national or international level) who are able to apply the results of the research. A distinction is sometimes drawn between direct users of the knowledge generated, usually companies, and end users, who buy the products from those companies. Both have a role to play in the innovation chain and must be referred to in the utilisation plan. User committees The creation of a users' committee forms part of the project management. After the research proposal has been granted, a minimum of four users should sit on the user committee. Research proposals from a medical faculty or university medical centre should have potential users. It is not sufficient in this case to state merely ‘the patient’ or ‘a clinic’. The aim of a users' committee is to bring together researchers and users (current or potential). It is a platform to exchange information, actively contribute ideas about the research and make suggestions for adjustment. It must meet at least twice a year. DHF will appoint (in close consultation of the project leader) one member of the users' committee. If the names of the users' committee are not yet known at the start of the project then they should be presented for approval first to DHF. User committee meetings are attended by the applicants/co-applicants, project/subproject leaders, the researchers temporarily appointed to the project, and the representatives of potential users. The project leader acts as chairman, a representative from DHF is present. During the course of a research project, DHF may change the composition of the user committee if there are grounds for doing so; such changes will always be made with the approval of the project leader. In doing so, DHF will make due allowance for the advice of the sitting users. The guiding principle will be to ensure that the composition of the user committee maximises the likelihood of the results being applied and that the exchange of ideas, including confidential information, remains possible. The committee can advise the project leader on the direction the research should take in order to promote the application of the results. The project leader always holds ultimate responsibility for the realisation of the research in accordance with the approved project plan.

After award A project agreement has to be signed when a grant is awarded. We explicitly advise you to carefully read the consortium agreement before submitting your proposal (Appendix 4).

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Appendix 1 Existing research consortia of projects linked to ‘Earlier recognition of cardiovascular diseases’ (not a comprehensive list, guideline) Investments of DHF or with a participation of DHF Name project/project leader/s

University

Disease

Keywords

Duration

INCOAG ten Cate

UM

Thrombosis

Biomarkers

2010-2015

EMINENCE Post

UM

Angiogenesis

Imaging techniques

2010-2015

PREDICCt Hofker

RUG

Biomarkers

2010-2015

COHFAR Vos

UU

Biomarkers

2010-2015

Circulating Cells Pasterkamp

UU

Biomarkers

2010-2015

Genius Kuiper/Kastelein

UL/UvA

Biomarkers

2012-2017

Predict Wilde/Vos

UU/UvA

Genetics

2013-2018

Reconnect Duncker/Verhaar DOSIS van der Velden/de Boer

EUR/UU VU/RUG

Atherosclerosis and DM HF and AF Atherosclerosis and instable plaques Atherosclerosis Ventricular fibrillation Renal and Heart Failure Cardiomyopathy

Kidney, endothelium, Hf Cardiomyopathy, genetics

2015-2020 2015-2020

Investments in Europe http://cordis.europa.eu/projects/home_en.html keywords: Netherlands, cardiovascular diagnosis, atherosclerosis Name project/project leader

University in Disease NL

EU-MASCARA

MU

atherosclerosis

biomarkers, genomics, 2011-2015 proteomics etc. Subclinical cardiovasc. Risk assessment

Combi-BIO

EUR

subclinical atherosclerosis

biomarkers, metabolic 2012-2014 proliferation

RADMED LIPHOS Veldhuis

MU RUG

oxidative stress endothelial dysfunction

Biomarkers bio photonic diagnostic tools

2012-2017 2012-2015

NANOATHERO VIA Brouwer CVGENES-AT-TARGET

AMC LUMC UU

Atherosclerosis atherosclerosis atherosclerosis

Imaging Vaccination Genomics

2013-2018 2013-2018 2013-2016

ATHERO-B-Cell Krol (adm)

UMCU

CVD

pro- en antiatherogenic B cell responses

2013-2018

Keywords

Duration

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HOMAGE Breek (adm)

ACS Biomarker BV Maastricht

presymptomatic HF

omics-based profiles

RESOLVE Annema

RUG

HDL/triglyc

Interaction 2013-2018 metabolism processes

AP Asymptomatic vessel damage

Imaging key molecular targets

DISCHARGE Katchaki LUMC SYSVASC Janssen (adm) ServiceXS BV Leiden

BM 2013-2019

2014-2019 2014-2018

Investments by ZonMw Name project leader

University NL

Feskens Wit

in

Disease

Keywords

Duration

WUR UMCU

Registries Diagnostics

2010-2015 2011-2015

Wanders Chen

AMC TU/e

Stronks Stoffers Boellaard Greevenbroek

AMC MUMC VUmc MUMC

Pathology general health Heart failure, mental health Rhythm disorders Imaging Diabetes

Lambers Heerspink Blaak

UMCG MUMC

Diabetes Nutrition

dietary database imaging pathology, mitochondrial devices, elderly ethnicity, cardiovascular atrial fibrillation imaging biomarkers, diabetes metabolomics, personalized microRNA

2012-2016 2012-2016 2012-2016 2013-2018 2014-2018 2014-2015 2014-2015 2015-2018

Key to university acronyms AMC EUR LUMC MUMC RUG TU/e UL UM

Academic Medical Center Erasmus University Rotterdam Leiden University Medical Center Maastricht University Medical Center+ University of Groningen Eindhoven University of Technology Leiden University Maastricht University

UMCU UU UvA VU VUmc WUR

University Medical Center Utrecht Utrecht University University of Amsterdam VU University Amsterdam VU University Medical Center Wageningen University and Research Centre

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STW projects and programmes Running projects (OTP en HTSM) http://www.stw.nl/nl/projecten

Running Perspectief programmes iMIT – Instruments for minimally invasive techniques http://www.stw.nl/nl/programmas/imit-%E2%80%93-instruments-minimally-invasive-techniques Population imaging genetics (ImaGene) http://www.stw.nl/nl/programmas/population-imaging-genetics-imagene

Other initiatives/consortia who might be relevant: ICIN http://www.icin.nl/onderzoek/projecten/ IMDI http://www.imdi.nl/ Medical Delta http://www.medicaldelta.nl/about

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Appendix 2 Format Preproposal The form is available on the websites of STW (via Iris) and DHF (please note the different submission protocols for part A and part B). The form is the same for both parts. Preproposals should be structured according to the following format: I General information max 1 A4 1. Title 2. Applying for part A or part B? 3. Abstract (max 350 words) 4. Contact information of the Applicant and of participating Principal Investigators/co-applicants 5. Duration 6. Amount requested 7. Keywords (max. 5) II Short Description: max 3 A4 1. Healthcare problem a. Which cardiovascular healthcare problem (suitable within this programme) must be solved b. How does the project fits the scope of this programme 2. Objectives of the project 3. Excellence/ innovative aspects 4. Concise description of the planned research 5. Expected results, at least a description should be given of: a. the expected results in relation to the healthcare problem and, b. the implementation thereof in clinic and industry. 6. Impact a. Application perspective (Describe here the economic and/or societal relevance and the possible impact of the research project for specifically the Netherlands as well as internationally. Please also state which results the users can expect immediately after the project, in how many years non-scientific applications can be realised and what the market for these is. What do you need for a broad implementation?) b. Utilisation plan (The utilisation plan must be clear for people without specific prior knowledge. Outline according to a step-by-step plan (during and after the project) how you will ensure that the research results are actually applied by users. State the expected obstacles to using the research results, for example due to IP or legislation. 7. Preliminary patent search results: 'freedom to operate' is essential here, i.e. no infringement on existing property rights of third parties. 8. Only is applying for part A: IP policy (see page 26 of the brochure): Please indicate for which option you intend to choose: 1 follow STW policy 2 making own arrangements III Consortium: max ½ A4 1. Expertise of the researchers involved 2. Interaction between disciplines 3. Embedding 4. User community (State here the intended user group and their commitment to the research. State the breadth of the users' community that will apply the results from the programme. Clearly state how all aspects of possible applications of the results are sufficiently covered with a relevant user or users. IV Preliminary budget forecast (max € 950,000 funding from STW/DHF) including contribution from users (overall and per centre): max ½ A4 Appendices: CV’s of applicant and principle investigator/co-applicants (max 1 A4 per person) Letters: (i) position of applicant and co-applicant(s), (ii) collaboration (or not) with national research programmes (iii) Statement of intent form possible users (part A) Pagina 40 van 62

Appendix 3 Partnership Project Agreement template (Part A) PARTNERSHIP PROJECT AGREEMENT Regarding the STW-Dutch Heart Foundation partnership "Earlier recognition of cardiovascular diseases"

THE PARTIES: 1. Technology Foundation STW, a foundation existing and organized under the laws of The Netherlands, with registered office at Van Vollenhovenlaan 661, 3527 JP Utrecht, The Netherlands, hereinafter to be referred to as "STW", in this matter duly represented by E.E.W. Bruins, CEO, 2. Dutch Heart Foundation, a foundation existing and organized under the laws of The Netherlands, with registered office at Prinses Catharina Amaliastraat 10, 2496 XD, The Hague, The Netherlands, hereinafter to be referred to as "Dutch Heart Foundation", in this matter duly represented by F. Italianer, CEO, 3. [_Name_],a research institute existing and organized under the laws of The Netherlands, with registered office at [_address_], hereinafter to be referred to as "Participant", in this matter duly represented by [_name_], 4. [_Name_],a company existing and organized under the laws of The Netherlands, with registered office at [_address_], hereinafter to be referred to as "Company", in this matter duly represented by [_name_], All parties hereinafter together and individually to be referred as "Parties" respectively "Party".

WHEREAS: A.

Dutch Heart Foundation is a charity organisation in the Netherlands that funds research, education, care and awareness campaigns aimed to reduce the burden of cardiovascular diseases.

B.

STW enables new technology by funding applied scientific research and promoting technology transfer.

C. STW and Dutch Heart Foundation have concluded a so-called 'Partnership Agreement', on the basis of which they invite Dutch universities and research institutes to submit project proposals in the field of the 'earlier recognition of cardiovascular diseases', with the intention to jointly fund the project proposals that are approved. D. The Participant has submitted the project proposal, titled [_title_], attached as Annex 1 to this Agreement ("Project Proposal"). The Project Proposal has been approved by decision of [_date_].

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E. The Parties now wish to lay down in writing the terms and conditions for the execution of the Project Proposal.

HAVE AGREED AS FOLLOWS: Article 1 – Definitions As used in this Agreement the following terms, either in plural or in the single form, have the following meaning: 1.

"Agreement" shall mean this agreement, including all annexes and amendments thereto.

2. "Background" shall mean all inventions, outcomes, materials, methods, processes, products, programmes, software, findings or discoveries that have been generated prior to or independent of a Project and are necessary for the Project or the utilisation of the Results. This includes any IPR to that Background. 3.

"Effective Date" shall mean the date on which the Project formally starts, which is when the Project leader undertook an initial expenditure of allocated funding or the date of the first appointment of personnel, whichever is first.

4.

"Income" shall mean the income (direct or indirect) resulting from the Project, including but not limited to income from license agreements relating to the use of Results, income from sale and transfer of (parts of) the Results and / or other related income, such as dividend and income resulting from an exit.

5. "IPR" shall mean all registered and unregistered intellectual property rights, including without limitation, patents, patent applications and rights to patent applications, trademark rights, design rights, copyrights (including rights in software), database rights, domain names, trade names and Know-how, and all other similar rights existing anywhere in the world and where such rights are obtained or enhanced by registration, any registration of such rights and applications and rights to apply for such registrations. 6. "Know-how" shall mean a package of non-patented practical information, resulting from experience and testing, which is: not public, that is to say, not generally known or easily accessible, substantial, that is to say, significant and useful for the production of the contract products, and identified, that is to say, described in a sufficiently comprehensive manner so as to make it possible to verify that it fulfils the criteria of secrecy and substantiality. 7. "Project" shall mean the research project for the performance of the activities in the field of [_description_], as described in the Project Proposal, for which funding has been awarded by STW and the Dutch Heart Foundation. 8. "Project Leader" shall mean an employee of the Participant with ultimate responsibility for the content and realization of the Project. 9. "Result(s)" shall mean all inventions, results, materials, methods, processes, products, programmes, software, findings or discoveries generated within a Project, and the IPR relating thereto. Pagina 42 van 62

10.

"Third Party" shall mean a natural person or legal entity other than STW or Users.

11. "User(s)" shall mean a natural person or legal person who is able to apply the Results of the Project and is a member of the User Committee. 12. "User Committee" shall mean a committee set up by STW consisting of Users, the Project Leader, other researchers and an STW representative and a Dutch Heart Foundation representative.

Article 2 – Conduct of the Project 1. The Participant shall conduct the Project in accordance with the Project Proposal, and the applicable "General Conditions" as attached in Annex 2, taking into account the criteria and standards applicable to – to the extent relevant – scientific and technological research. The Participant shall conduct the Project during the term of this Agreement. 2. For the performance of the Project, the Participant shall select and appoint personnel with appropriate qualifications. [_name_] shall be appointed as Project Leader. The Participant shall ensure that the Project Leader and the other appointed personnel comply with the obligations imposed on the Participant and its employees in this Agreement. Breach by the employee or Project Leader is considered as a breach of this Agreement by Participant. 3. The Project Leader will complete the Project within 5 years after the starting date of the Project, unless otherwise agreed between the Parties in the Project Proposal. 4. In realizing the Project, the Participant will comply with all applicable legislation and will behave in an ethically acceptable manner as may be expected in – to the extent relevant – scientific and technological research. The Participant shall inform STW and Dutch Heart Foundation immediately if new information emerges which is relevant to (the conduct of) the Project or the utilization of the Results. 5. A User Committee will be formed. The Project Leader chairs the User Committee and a representative of STW shall act as its secretary. The User Committee shall meet at least twice a year. During such meeting, the User Committee shall discuss the progress of the Project, on the basis of the written progress report, prepared by the Project Leader. The progress report shall be sent at least two weeks before the User Committee meeting and shall contain amongst others a description of the Results obtained so far. The Project Leader shall use the format, as can be found at on the website of STW. 6. The Participants will make best efforts to ensure that the training programmes of the [researchers] include at least 2 of the 3 PhD training courses of the Dutch Heart Foundation that are held annually. The training programmes of the researches will be provided to the Dutch Heart Foundation upon its first request. 7. During the execution of the Project it can be observed by the Dutch Heart Foundation that activities in certain areas within the different Projects funded on the basis of the Partnership Agreement are almost identical / complementary. In such case, linkages will be made to operate as Pagina 43 van 62

efficiently as possible and to possibly secure key infrastructure for the Dutch cardiovascular research. The Parties are obliged to fully cooperate and provide all necessary information to the Dutch Heart Foundation.

Article 3 – Funding and payment 1. The Participant is according to the Project Plan entitled to compensation of expenses, incurred by the Participant in the execution of the Project. For the performance of the Project, STW and Dutch Heart Foundation have budgeted an amount of € [_amount_], including VAT. The conditions on the basis of which the Participant can claim compensation for its expenses, are described in the document 'General Conditions', attached to this Agreement. 2. The Participant contributes to the Research by paying the salaries of the Project Leader and other (permanent) researchers, associated academic facilities and infrastructure. 3. Company or Companies, as applicable, shall make a contribution in cash to the Project of [AMOUNT] (ex VAT). Company shall make a contribution kind to the Project representing an estimated value of [AMOUNT]. The contribution in kind consists of:

• • •

[PERSONNEL] with a value of [AMOUNT] (ex VAT); [MATERIAL] with a value of [AMOUNT] (ex VAT); [EQUIPMENT] with a value of [AMOUNT] (ex VAT).

According to article 5.4 and 5.6 of the General Conditions, STW pays the funding to the Participant and the supplier respectively. 50% of the amounts payable in this respect will actually be paid by Dutch Heart Foundation (on the basis of article 6:30 Dutch Civil Code, which regards performance of an obligation by a person [Dutch Heart Foundation] other than the obligor [STW]). The Participant or supplier will not have an independent claim vis-à-vis Dutch Heart Foundation regarding payment of the funding or any other payment. For the avoidance of doubt, the Heart Foundation and STW are not jointly and severally liable (hoofdelijk aansprakelijk) for the total funding amount payable to the Participants pursuant to this Agreement. 4. STW and Dutch Heart Foundation are entitled to any remaining budget, after the Project has been ended.

Article 4 - Results 1. STW and Dutch Heart Foundation have funded the Project according to its General Conditions and the applicable policy concerning rights to Results, IPR and publication which is laid down in detail in Annex 3. Besides the option to obtain a license or transfer of the Results, the STW, the Participant or any other co-owners of the Results may decide to utilise the Results by participating in a "spin-off company" or otherwise. It is agreed that in such event, the Income realised, such as dividend or income realised with an exit, will also be considered as Income deriving from the Project and will be divided in accordance with Article 4(6). In the event that Parties chose Option 2, it is agreed that a certain percentage of the Income generated by those Parties will be paid to the Dutch Heart Pagina 44 van 62

Foundation. The percentage will be agreed upon between the Participant, Company and the Dutch Heart Foundation during the discussions about the Own IP&P arrangements. 2. The Participant shall ensure that both its employees as well as any involved Third Parties who might be able to claim rights to the Results, transfer those rights to the Participant and STW. 3. In return of the contribution the Parties hereby grant to Dutch Heart Foundation a license to use the Results for further non-commercial, internal research and education, fund raising and publication purposes, which license the Dutch Heart Foundation hereby accepts. 4. The Project Leader shall inform the Parties immediately if Results are generated which are eligible for protection by a patent. The Project Leader shall then complete an invention disclosure form, the format for which can be found on the website of STW. Based on said invention disclosure form, Parties shall decide within three (3) months whether the Results will be patented. In case of a positive decision, the Parties shall agree on the details for the patent application procedure. The patent application shall be filed on behalf of STW and the Participant. 5. Based on the contribution as mentioned in article 3.3. Company will have the following rights on Results:

•

• •

6.

0-10% contribution of the total Project costs, Company acquires no automatic rights to Results; 11-30% contribution of the total Project costs, Company acquires right of option to the Results, as further described in the General Conditions; 31-50% contribution of the total Project costs, Company acquires a nonexclusive non-transferable commercial license + right of option to obtain exclusive rights, as further described in the General Conditions.

All positive Income deriving from the Project will be divided as follows:

c.

a. the costs incurred by STW and/or the Participant(s) directly relating to obtaining IPR protection of the Results (including application or maintenance fees payable to the relevant Patent Office or any other Intellectual Property Office but excluding – for the avoidance of doubt – costs relating to enforcement of IPR and defence of the validity of IPR in opposition or court proceedings and any overhead costs) are deducted from the total Income. In the event that such costs are higher than the Income, the Dutch Heart Foundation will not be obliged to compensate the 'negative' Income. STW, the Participant(s) and other co-owners of the Results will use their best endeavours to maximise the Income deriving from the Project and will provide the Dutch Heart Foundation access to their calculation of the Income deriving from the Project at its first request; b. STW transfers 50% of the positive Income, after the deduction as mentioned in article 9(4)(2)(a), directly to a bank account to be designated by the Participant; 25% of the positive Income, after the deduction as mentioned in article 9(4)(2)(a), up to a cumulative total of €250.000 is allocated by STW on a declaration basis to the Project Leader for the purposes of research. For this allocation, the Project Leader submits a budget proposal and project plan which is globally reviewed by STW; d. STW transfers 25% of the positive Income, after the deduction as mentioned in article 9(4)(2)(a) directly to Dutch Heart Foundation;

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e. if the total positive Income after the deduction as mentioned in article 9(4)(2) (a) exceeds €1.000.000, STW, the Dutch Heart Foundation and the Participant will confer on the division of the fee in excess of the amounts paid to the Project Leader pursuant to sub (c) above. Article 5 – Confidentiality and publication 1. All information of whatever nature or form disclosed within the Project by a Party (the "Discloser") to any other Party (the "Receiver") in connection with the Project as well as the contents of this Agreement, Background, and any and all Results and/or conclusions emanated from the purpose and which: a. if disclosed in tangible form, was marked as confidential at the time of such disclosure; or b. if disclosed orally, was identified as confidential at the time of such disclosure and confirmed as confidential in writing within 30 days after disclosure; or c. if disclosed either in tangible form or orally, by its nature or the circumstances under which it is disclosed must reasonably be considered to be confidential; is "Confidential Information". 2. Each Party undertakes to hold the Confidential Information of another Party both during the term of this Agreement as well as 5 (five) years longer than the duration of the Project, and in respect of the Background and Results for an unlimited period of time, in strictest confidence and not to disclose or allow the disclosure of the Confidential Information to another Party or to make the Confidential Information of another Party or any part thereof, publicly available. A Party shall treat the Confidential Information of another Party with the same degree of care that it applies to its own confidential information (but in any case not less than reasonable care). 3. Each Party undertakes to use the Background of another Party and the Results only in accordance with the terms of this Agreement. 4. The aforementioned obligations and prohibitions are not applicable to the Confidential Information or any part thereof: a. has come into the public domain prior to, or after the disclosure thereof and in such case through no wrongful act of the receiving Party; b. was already known to the receiving Party, as evidenced by written documentation in the files of the receiving Party; c. has been lawfully received by a Party without restrictions or breach of this Agreement; d. has been or is published without violation of this Agreement; or e. is independently developed in good faith by employees of the receiving Party who did not have access to the confidential information. o The burden of proof lies with the Receiver. 5. Each Party is entitled to give its employees access to the Confidential Information of another Party, as far as such is necessary for them to fulfill their tasks. Each Party will ensure that its employees will hold the Confidential Information of another Party in strictest confidence and use the Confidential Information in accordance with the provisions of this Agreement.

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6. Parties recognize the desire to publish Results and/or details of academic research in scientific journals, and/or present these at scientific meetings. Parties also recognize the desire to preserve the IPR arising out of the Project. Therefore, Parties shall have the right to publish scientific Results of the Project, subject to the provisions in this article 5. Parties shall be furnished with a copy of any proposed publications for review and comment, prior to the submission for publication, for manuscripts at least thirty (30) days prior to submission, and for abstracts at least ten (10) days prior to submission. 7. The Party that proposed publication agrees to give good faith consideration to any comments or suggestions which are offered by the other Parties within the time limits set forth in article 5 (6). In addition, at a Party's request, the Party that proposed publication shall delay any proposed publication disclosing inventions, ideas, or other IPR for which any of the other Party intends to obtain patent protection, until such time that proper submission of patent application(s) has been completed. The Party that intends to obtain patent protection shall limit any such delay to a maximum period of three (3) months, after which period the publication may be disclosed. 8. The Participant shall ensure that every scientific publication contains the following declaration to indicate that the Results were achieved with financial support from STW and Dutch Heart Foundation: "This research has been made possible by the Dutch Heart Foundation and Technology Foundation STW, as part of their joint strategic research programme: "Earlier recognition of cardiovascular diseases". and for Dutch publications: "Dit onderzoek is mogelijk gemaakt door de Hartstichting en Technologiestichting STW als onderdeel van het gezamenlijke onderzoeksprogramma "Eerder herkennen van hart- en vaatziekten". Where possible, the publications, including scientific posters and prototypes, should also contain the official "gesubsidieerd door" logo of Dutch Heart Foundation and STW. The Participant shall furthermore consult with Company whether Company wants its support to the Project to be mentioned as well in the publication. 9. For the purposes of reporting to the government and the society, and to raise funds, STW and Dutch Heart Foundation may publish non-enabling summaries of the Project following consultation with the Project Leader. Parties are obliged to collaborate for these purposes. STW and Dutch Heart Foundation shall ensure that such summaries shall not affect the possibility of applying for patent rights with regard to the Results.

Article 6 – Liability and warranties 1.

Each Party is responsible for its own actions and omissions under this Agreement.

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2. Parties agree to indemnify each other against and hold each other harmless from any claims, damages, losses and expenses arising out of the execution of their respective acts in respect to this Agreement and/or the use of the Results, including rights and obligations that originate of this. 3. Notwithstanding article 2.1 above, the Participant makes no representation and extends no warranty of any kind, either express or implied, with regard to the effectiveness, merchantability or fitness for a particular purpose of the Results.

Article 7 – Term and termination 1. This Agreement shall become effective on the Effective Date and shall thereafter remain into force until the end of the Project. The end of the Project is the last day of service of the last researcher funded by STW pursuant to this Agreement. 2. After this Agreement has ended, the articles 4, 5, 6, 7.2, 8 and 9 shall remain in full force and effect. 3. If the participation of a Party in the Agreement is terminated prematurely on the basis of the law, the other Parties shall discuss if they wish to continue the Agreement and on what conditions. Should the participation of the Participant be terminated and the other Parties decide that they nevertheless want to continue the Project, the Participant will, at the request of STW and Dutch Heart Foundation, cooperate to the best of its ability in transferring the Project to the selected new research institute. 4.

When the participation of a Party has been terminated as meant in paragraph 3 above, paragraph 2 above shall apply, with the understanding that said Party shall not acquire any rights with regard to the Results, generated after the termination of its participation. 5. Each Party is entitled to terminate this agreement vis-à-vis a Party by written notice sent by registered mail to the other Party a. if the other Party is in breach of this agreement and the breach is not remedied within thirty (30) days of the other Party receiving written notice specifying the breach and requiring its remedy or b. if the other Party is declared bankrupt, if a suspension of payment is requested or granted for insolvency reasons, or is transferred, closed down or liquidated or if an administrator or receiver is appointed for the other Party.

Article 8 - Governing law and jurisdiction 1.

This Agreement shall be governed by the laws of the Netherlands.

2. If any dispute should arise between the Parties further to the present Project Agreement, the Parties shall use reasonable effort to settle such dispute through mediation before pursuing any remedy they may have at law. For the purposes of resolution of each and any dispute that has arisen further to this Agreement, the Parties shall – or the most diligent Party shall – file a request for mediation with the NAI (Nederlands Arbitrage Instituut) secretariat in accordance with the NAI Mediation Rules.

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3. If such request fails to result in a comprehensive resolution of the dispute by execution of a settlement agreement as referred to in Article 7(A) of the NAI Mediation Rules, the dispute – or at any rate any part thereof not resolved in the aforesaid manner – shall be submitted to the competent court in Utrecht, The Netherlands.

Article 9 - Miscellaneous 1. None of the Parties shall be entitled to transfer, by means of assignment, sale or otherwise, or to encumber any and all of the rights granted under and obligations deriving from this Agreement, either in whole or in part, to a third party without the prior written consent of the other Parties which consent shall not be unreasonably withheld. 2. Unless explicitly agreed otherwise in writing, none of the Parties is entitled to act or make legally binding declarations on behalf of any of the other Parties. Nothing in this Agreement shall be deemed to constitute a joint venture, agency or any other kind of formal business grouping or entity between the Parties. 3. Any amendments or additions made to the Agreement shall only be valid and binding between the Parties if made in writing and executed by all Parties. 4.

This Agreement contains three annexes which form an integral part of this Agreement:

Annex 1 Project Proposal '[_title_]' Annex 2 General Conditions Annex 3 IP-policy STW-DHF Partnership In the event of a conflict between this Agreement and an Annex, the Agreement shall prevail. 5. None of the Parties grants any rights and/or licenses to the other Parties, either explicit or implicit, nor waives any of its existing rights, unless explicitly mentioned in this Agreement. 6. Dutch Heart Foundation does not qualify as a user or third party as referred to in the General Conditions. 7. This Agreement is entered into under the condition precedent of consent to this Agreement of the supervisory board of Dutch Heart Foundation.

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Signed in fourfold,

____________________ Technology Foundation STW By: E.E.W. Bruins Place: Date:

____________________ Dutch Heart Foundation By: Place: Date:

_____________________ [________________] By: Place: Date:

[________________] By: Place: Date:

Pagina 50 van 62

Appendix 4 Consortium agreement template (Part B) DEFINITIEVE OVEREENKOMST SUBSIDIEVERLENING DOOR DE NEDERLANDSE HARTSTICHTING VANWEGE CARDIOVASCULAIR ONDERZOEK NEDERLAND CALL: EERDER HERKENNEN VAN HART- EN VAATZIEKTEN. ONDERZOEKSPROJECT ‘’ MET CVON NUMMER CVON2015ONDERGETEKENDEN: 1.

de stichting Nederlandse Hartstichting, gevestigd te 's-Gravenhage te dezen overeenkomstig artikel 11 lid 1 van haar statuten vertegenwoordigd door haar directeur, drs. F. Italianer, hierna te noemen: de "Hartstichting";

2.

het, in dezen vertegenwoordigd door, hierna te noemen: "Subsidie-ontvanger".

3.

de, gevestigd te, in dezen vertegenwoordigd door, hierna te noemen: “Instelling 1”.

4.

het, gevestigd te, in dezen vertegenwoordigd door, hierna te noemen: “Instelling 2”.

5.

het, gevestigd te, , in dezen vertegenwoordigd door, hierna te noemen: “Instelling 3”.

6.

het, gevestigd te, , in dezen vertegenwoordigd door, hierna te noemen: “Instelling 4”.

7.

Partijen 2 t/m 6 zullen hierna tezamen worden aangeduid als “Instellingen”.

OVERWEGENDE DAT: A. De Hartstichting, KNAW, NWO/ZonMw en NFU de handen ineen hebben geslagen en het initiatief CardioVasculair Onderzoek Nederland (CVON) steunen: van, voor en door cardiovasculaire onderzoekers. De Hartstichting beheert de organisatie van CVON m.b.t. procedures, selectieprocessen en voortgang van de projecten en thema’s, zowel inhoudelijk als financieel. B. De Subsidie-ontvanger het voornemen heeft om in samenwerking met een aantal andere kennisinstellingen en onderzoekers (tezamen het Consortium, zoals hieronder gedefinieerd) onderzoek uit te voeren op een gebied dat de aandacht van de Hartstichting heeft, waaronder het hieronder gedefinieerde Onderzoeksproject. C. De Subsidie-ontvanger behoefte heeft aan financiering van het Onderzoeksproject en de Hartstichting bereid is een deel van deze financiering te verstrekken door het verlenen van een subsidie, onder de in deze definitieve overeenkomst subsidieverlening (de "Definitieve overeenkomst") genoemde voorwaarden.

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1.

Definities

1.1

Consortium: samenwerkingsverband tussen de Instellingen en Onderzoekers.

1.2

Consortiummanagement: orgaan dat verantwoordelijk is voor de financiële en administratieve coördinatie van het Onderzoeksproject onder supervisie van de Subsidie-ontvanger.

1.3

Intra-consortium overeenkomst: de overeenkomst tussen de Instellingen die deelnemen aan het Consortium met betrekking tot de uitvoering van het Onderzoeksproject.

1.4

ISAC: International Scientific Advisory Committee. Internationale adviescommissie die Hartstichting adviseert over de volgende zaken: de ingediende projectvoorstellen, de midtermrapportage en de eindrapportage.

1.5

Kosten: alle kosten die redelijkerwijs toegerekend kunnen worden aan het genereren van revenuen op Resultaten, zoals bijvoorbeeld: patentkosten, licentiekosten, betaalde en niet te verrekenen BTW, valorisatiekosten voor de Instelling en vergoedingen voor een exploiterende partij, maar exclusief algemene overheadkosten van een Insteling.

1.6

Netto- Revenuen: Revenuen minus de Kosten, voor zover deze positief zijn met een ondergrens van 500,-- euro.

1.7

Onderzoekers: de Onderzoeksleider, principal investigators en de andere bij het Onderzoeksproject betrokken onderzoekers.

1.8

Onderzoeksleider: de onderzoeker die verantwoordelijk is voor de uitvoering van het Onderzoeksproject, krachtens een arbeidsovereenkomst verbonden aan de Subsidie-ontvanger.

1.9

Onderzoeksproject: het onderzoeksproject op een gebied dat de aandacht van de Hartstichting heeft, zoals nader omschreven in de Subsidieaanvraag.

1.10

Revenuen: de gerealiseerde opbrengsten die (direct of indirect) voortkomen uit het Onderzoeksproject en/of de exploitatie of (gedeeltelijke) vervreemding van de Onderzoeksresultaten en/of de Intellectuele Eigendomsrechten, waaronder begrepen maar niet beperkt tot inkomsten uit licentieovereenkomsten, opbrengsten uit vervreemding van (delen van) de Onderzoeksresultaten en/of Intellectuele Eigendomsrechten en/of overige gerelateerde opbrengsten, zoals bijvoorbeeld dividend en winst bij exit.

1.11

Subsidie: een bedrag dat de Hartstichting bereid is ter financiering van een gedeelte van het Onderzoeksproject aan de Subsidie-ontvanger te verstrekken. De Subsidie is geen subsidie in de zin van artikel 4:21 van de Algemene wet Bestuursrecht.

1.12

Subsidieaanvraag: de (uitgewerkte) subsidieaanvraag ingediend door de Onderzoeksleider 15 december 2015, de voorlopige toewijzing van xx 2016 ("Voorlopige Toewijzing") en de herziene begroting zoals goedgekeurd door de Hartstichting op …. ("Herziene Begroting") en alle nadien gemaakte afspraken vastgelegd in correspondentie tussen de Hartstichting en de Onderzoeksleider (bijlage 1).

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2.

Verlening en uitbetaling subsidie

2.1

De Hartstichting verleent hierbij een Subsidie aan de Subsidie-ontvanger voor de uitvoering van het Onderzoeksproject onder de in deze Definitieve overeenkomst genoemde voorwaarden, welke verlening de Subsidie-ontvanger hierbij aanvaardt.

2.2

De Subsidie is in eerste instantie toegewezen door middel van een Voorlopige Toewijzing. Deze Voorlopige Toewijzing geeft een indicatie van de hoogte van het toe te wijzen bedrag. Aan de Voorlopige Toewijzing kunnen geen rechten worden ontleend.

2.3

De Subsidie voor de uitvoering van het Onderzoekproject wordt voor een periode van 5 jaar toegewezen.

2.4.

Op basis van de Herziene Begroting (bijlage 1) is de hoogte van de Subsidie vastgesteld op … euro. Dit bedrag is het maximaal door de Hartstichting toe te wijzen bedrag voor het Onderzoeksproject.

2.5

De Subsidie wordt niet eerder uitbetaald (opschortende voorwaarde) aan de Subsidie-ontvanger dan dat: (a) is voldaan aan de afspraken die zijn gemaakt in de startgesprekken met de Onderzoeksleider, zoals vastgelegd in de correspondentie in bijlage 1; (b) de Intra-consortium overeenkomst is ondertekend waarin minimaal is vastgelegd: •

organisatiestructuur van het consortium

•

eigendoms- en gebruiksrechten

•

publicatieprocedure

•

data-sharing

(c) deze Definitieve overeenkomst is ondertekend. 2.6

Subsidie-ontvanger zal zorgen voor de verdeling van de Subsidie onder de Instellingen conform de Herziene Begroting (bijlage 1).

2.7

Uitbetaling van de Subsidie door de Hartstichting aan de Subsidie-ontvanger vindt in beginsel plaats in halfjaarlijkse termijnen en zal worden betaald tot de midterm-review. De Hartstichting zal de midterm-review gebruiken als ijkpunt m.b.t. de financiën, de Herziene begroting wordt vergeleken met daadwerkelijk besteed. Het resterende budget kan naar aanleiding van deze toetsing worden bijgesteld. Na positief advies van de ISAC over de midterm-rapportage aan de directie van de Hartstichting, zal de Hartstichting de, mogelijk aangepaste, betalingen weer opstarten. Als de ISAC negatief adviseert over een midterm-rapportage aan de directie van de Hartstichting, kan de Hartstichting de Subsidie geheel of gedeeltelijk stopzetten, onverminderd het bepaalde in artikel 12.2 van de Definitieve overeenkomst. De Hartstichting zal eveneens de eindrapportage gebruiken als ijkpunt m.b.t. de financiën, de Herziene begroting wordt vergeleken met daadwerkelijk besteed. De uitbetaling van de laatste termijn kan naar aanleiding van deze toetsing worden bijgesteld en vindt plaats na positief advies van de ISAC over de eindrapportage aan de directie van de Pagina 53 van 62

Hartstichting. Als de ISAC negatief adviseert over de eindrapportage aan de directie van de Hartstichting, dan is de Hartstichting gerechtigd om laatste termijn niet uit te betalen, onverminderd het bepaalde in artikel 12.2 van de Definitieve overeenkomst. 2.8

In uitzondering op het onder 2.7 gestelde zal het in het Onderzoeksproject onder de sectie IX beschreven “Development of (young) talent” op declaratiebasis worden uitbetaald. De Hartstichting zal de midterm-review gebruiken als ijkpunt m.b.t. de financiën, de Herziene begroting wordt dan vergeleken met daadwerkelijk besteed. Het resterende budget kan naar aanleiding van deze toetsing worden bijgesteld.

3.

Aanvang van het Onderzoeksproject

3.1

De startdatum van het Onderzoeksproject is ..-..-2016.

4.

Besteding van de Subsidie

4.1

De Hartstichting vergoedt uitsluitend het in artikel 2.4 genoemde bedrag. De Hartstichting aanvaardt geen aansprakelijkheid voor de overige direct of indirect aan het Onderzoeksproject toerekenbare kosten, noch voor enige kostenoverschrijdingen.

4.2

De Onderzoekers zullen de Subsidie besteden conform de Herziene Begroting opgenomen in bijlage 1 bij de Definitieve overeenkomst. De Instellingen zijn ervoor verantwoordelijk dat de Onderzoekers deze verplichting nakomen.

4.3

De Instellingen garanderen dat er geen andere financiële bronnen voor het Onderzoeksproject zijn, anders dan aangegeven in de Subsidieaanvraag (bijlage 1).

5.

Uitvoering van het Onderzoeksproject

5.1

De Onderzoekers zullen het Onderzoeksproject uitvoeren onder leiding van de Onderzoeksleider, volgens de in de Subsidieaanvraag beschreven sectie V “Extended scientific programme”, rekening houdend met het advies van de ISAC dat mede gebaseerd is op de aanbevelingen van de ingeschakelde referenten (bijlage 1) en de Commissie Maatschappelijke Kwaliteit. De directie van de Hartstichting benut hierin het advies van ISAC. De Instellingen zijn ervoor verantwoordelijk dat de Onderzoekers deze verplichting nakomen.

5.2

De Instellingen zijn ervoor verantwoordelijk dat het Consortium zal functioneren overeenkomstig de aangegeven organisatie- en beslisstructuur vermeld onder sectie VIII punt 2 van de Subsidieaanvraag (bijlage 1). Indien een advisory board wordt ingesteld, mogen hierin geen leden zitting nemen van de ISAC. De samenstelling van de advisory board dient goedgekeurd te worden door de directie van de Hartstichting.

5.3

Onderzoeksleider is het eerste aanspreekpunt voor de Hartstichting en alle communicatie omtrent de uitvoering van het Onderzoeksproject verloopt via deze Onderzoeksleider.

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5.4

De Onderzoekers zijn verplicht een voornemen tot wijziging in de uitvoering van het Onderzoeksproject, waaronder bijvoorbeeld een wijziging in de onderzoeksopzet, de Herziene Begroting of het vertrek van één van de Onderzoekers, onmiddellijk te melden aan de Hartstichting. Instellingen zijn ervoor verantwoordelijk dat de Onderzoekers deze verplichting nakomen. Indien de voorgelegde wijziging zodanig is dat de directie van de Hartstichting tussentijds behoefte heeft aan advies van de ISAC en de ISAC negatief adviseert aan de directie van de Hartstichting over de voorgestelde wijzigingen, kan de Hartstichting de Subsidie geheel of gedeeltelijk stopzetten, onverminderd het bepaalde in artikel 12.2 van de Definitieve overeenkomst.

5.5

De Hartstichting verwacht dat de Instellingen zich ervoor zullen inspannen dat in het opleidingsplan van iedere aan te stellen AIO, in ieder geval 2 van de 3 PhD- training courses van de Hartstichting, die jaarlijks plaatsvinden, zijn opgenomen. De bedoelde opleidingsplannen dienen opvraagbaar te zijn bij het Consortiummanagement.

5.6

a. Indien een van de Onderzoekers voornemens is om in het kader van het Onderzoeksproject een klinische trial te starten, dan is de Onderzoeksleider, al dan niet tezamen met de betrokken Onderzoeker, verplicht vooraf in overleg te treden met het Interuniversitair Cardiologisch Instituut Nederland (ICIN), om te bepalen of de trial onder begeleiding van het ICIN zal kunnen worden uitgevoerd. b. Er zal tevens overleg worden gevoerd met het ICIN/ Durrer-Center met betrekking tot het onderbrengen van data en samples. De Instellingen zijn ervoor verantwoordelijk dat de Onderzoeksleides deze verplichting nakomt. Het niet gebruik maken van deze faciliteiten dient schriftelijk te worden beargumenteerd.

5.7

De Instellingen garanderen dat het Onderzoeksproject wordt uitgevoerd volgens alle toepasselijke nationale en internationale regelingen, waaronder mede begrepen de Gedragscode Goed Gebruik 2011, de Gedragscode Gezondheidsonderzoek en de Gedragscode Wetenschapsbeoefening 2014. De Instellingen garanderen dat zij en de andere deelnemers van het Consortium in het bezit zijn van alle wettelijke vereiste autorisaties en documentatie, zoals de METC-, DEC- en CCMO-goedkeuringen en alle andere documenten die van belang zijn voor een goede uitvoering van het Onderzoeksproject. De Instellingen zullen ervoor zorgen dat kopieën van deze autorisaties en documentatie in bezit zijn van het Consortiummanagement en dat deze op verzoek van de Hartstichting aan hun worden overhandigd.

5.8

Tijdens de uitvoering van het Onderzoeksproject kan geconstateerd worden dat activiteiten op bepaalde terreinen binnen de verschillende CVON-consortia nagenoeg identiek/complementair zijn. In zulks geval zullen dwarsverbanden gelegd worden om zo efficiënt mogelijk te kunnen werken en om mogelijk belangrijke infrastructuur voor het Nederlandse cardiovasculaire onderzoek veilig te stellen. Het Consortium is verplicht hieraan volledige medewerking te verlenen en alle nodige informatie te verschaffen.

6. 6.1

Rapportages/Verantwoording De Onderzoeksleider dient een midterm-rapportage op te stellen. Subsidie-ontvanger, Instelling1 en de Onderzoeksleider zijn ervoor verantwoordelijk dat deze verplichting wordt nagekomen. Begin Pagina 55 van 62

2019 ontvangt Onderzoeksleider, de datum waarop de midterm-rapportage ingediend moet zijn. Richtlijnen en instructies worden tijdig bekend gemaakt. De midterm review is een belangrijk beslismoment in de voortgang van het Onderzoeksproject. Als de ISAC negatief adviseert over een midterm-rapportage aan de directie van de Hartstichting, kan de Hartstichting de Subsidie geheel of gedeeltelijk stopzetten, onverminderd het bepaalde in artikel 12.2 van de Definitieve overeenkomst. 6.2

De Onderzoeksleider dient een eindrapportage op te stellen. Subsidie-ontvanger, Instelling1 en de Onderzoeksleider zijn ervoor verantwoordelijk dat deze verplichting wordt nagekomen. Begin 2021 ontvangt Onderzoeksleider de datum waarop de eindrapportage ingediend moet zijn. Richtlijnen en instructies worden tijdig bekend gemaakt. De eindevaluatie is een belangrijk evaluatiemoment met betrekking tot de afronding/het succes van het Onderzoeksproject. Als de ISAC negatief adviseert over de eindrapportage aan de directie van de Hartstichting, dan is de Hartstichting gerechtigd om laatste termijn niet uit te betalen, onverminderd het bepaalde in artikel 12.2 van de Definitieve overeenkomst.

6.3

Ten minste 1x per jaar vindt overleg plaats tussen Onderzoeksleider en een of meer vertegenwoordigers van de Hartstichting. De Hartstichting zal tijdig aangeven welke informatie vooraf beschikbaar moet zijn. De Hartstichting zal deze overleggen tevens gebruiken als ijkpunt m.b.t. de financiën, de Herziene begroting wordt vergeleken met daadwerkelijk besteed. Het resterende budget kan naar aanleiding van deze toetsing worden bijgesteld. Ook het onderwerp communicatie maakt onderdeel uit van dit overleg, evenals het proefdiergebruik.

7.

Wetenschappelijke publicaties

7.1

De Onderzoekers dienen de resultaten, zowel positief als negatief, van het gesubsidieerde Onderzoeksproject op de gebruikelijke nationale en internationale toegankelijke wijze te publiceren. De Instellingen en de Onderzoeksleider zijn ervoor verantwoordelijk dat de Onderzoekers deze verplichting nakomen. De publicaties dienen door de Hartstichting te kunnen worden opgevraagd bij het Consortiummanagement. De publicaties zijn onderdeel van de onder 6.3 genoemde overleggen met een of meer vertegenwoordigers van de Hartstichting.

7.2

De onderzoekers zijn verplicht om in alle wetenschappelijke publicaties die voortkomen uit het Onderzoeksproject de steun van de Hartstichting/CVON te vermelden, t.w.: “Dit Onderzoek maakt deel uit van het CVON, een initiatief met steun van de Hartstichting, CVON2015- …. ACRONIEM” of “We acknowledge the support from the Netherlands Cardiovascular Research Initiative ": An initiative with support of the Dutch Heart Foundation, CVON2015- …. ACRONIEM. Alleen de wetenschappelijke publicaties waarin de Hartstichting/CVON aldus wordt vermeld, worden gebruikt voor het vaststellen en beoordelen van de wetenschappelijke kwaliteit en kwantiteit van het gesubsidieerde Onderzoeksproject.

7.3

De Onderzoekers zijn daarnaast verplicht om tijdens alle voordrachten, (poster)presentaties en/of interviews die over het Onderzoeksproject worden gehouden, het logo van de Hartstichting duidelijk zichtbaar te tonen, waarbij wordt vermeld: “Dit onderzoek maakt deel uit van het CVON, een initiatief met steun van de Hartstichting, CVON2015- …. ACRONIEM of “We acknowledge the Pagina 56 van 62

support from the Netherlands Cardiovascular Research Initiative ": An initiative with support of the Dutch Heart Foundation, CVON2015- …. ACRONIEM. Voor alle presentaties dient het Hartstichting-format te worden gebruikt. 7.4.

De Hartstichting mag informatie uit de goedgekeurde aanvragen, tussenrapportages en eindrapportages opnemen in haar onderzoeksinformatiesysteem en zij mag deze informatie, na overleg met Onderzoeksleider 1, openbaar maken onder meer via social media.

8.

Wetenschapseducatie/Wetenschapscommunicatie

8.1

Instellingen verklaren bereid te zijn over het Onderzoeksproject te communiceren en om, in overleg en afstemming met de Hartstichting gezamenlijk fondsen te werven voor de Hartstichting. Het doel is wetenschapseducatie (het vertrouwd maken van wetenschappelijke inzichten en enthousiasme voor wetenschap naar een breder publiek), fondsenwerving en verantwoording en transparantie (voor doelgroepen inzichtelijk maken op welke wijze gelden besteed worden, met welk beoogd resultaat).

8.2

Een vertegenwoordiging van de Hartstichting richt zich tot Onderzoeksleider als het aanspreekpunt voor de interne en externe communicatie.

8.3

Alleen in overleg met en na goedkeuring van de Hartstichting zullen Instellingen en Onderzoekers met derden communiceren over het Onderzoeksproject. Bij alle uitingen over het Onderzoeksproject dient vermeld te worden dat de Hartstichting het onderzoek steunt.

8.4

Indien (één van) de Instellingen besluit(en) het Onderzoeksproject en/of een eventuele promotie voortvloeiend uit het Onderzoeksproject in de publiciteit te brengen, dien(t)(en) (één van) de Instellingen hierover van te voren contact op te nemen met de Hartstichting. Dit geldt eveneens voor niet- wetenschappelijke publicaties. Indien er sprake is van een persbericht, moet in de lead vermeld worden dat het Onderzoeksproject financieel gesteund is door de Hartstichting. Uiterlijk drie dagen voor verzending moet het conceptpersbericht voor akkoord voorgelegd worden aan de Hartstichting.

8.5

Indien de Hartstichting zelf besluit publiciteit te zoeken over het Onderzoeksproject en/of een eventuele promotie voortvloeiend uit het Onderzoeksproject, zijn de Instellingen verplicht hieraan alle medewerking te verlenen. De Instellingen staan ervoor in dat indien nodig ook de Onderzoekers die betrokken zijn geweest bij het Onderzoeksproject hieraan hun medewerking zullen verlenen.

8.6

Activiteiten op het gebied gezamenlijke fondsenwerving en van wetenschapseducatie en communicatie krijgen duidelijk een plaats in de evaluaties (halverwege en aan het einde van het traject). Deze activiteiten worden nadrukkelijk gezien als een vorm van kennisvalorisatie.

9.

Intellectuele eigendomsrechten en licentieovereenkomsten

9.1

De Onderzoeksleider za de Hartstichting op diens eerste verzoek in kennis te stellen van al hetgeen is voortgevloeid uit het Onderzoeksproject, waaronder in ieder geval begrepen, maar niet beperkt tot de onderzoeksresultaten, vervaardigde documenten en materialen, ontwerpen, schetsen, afbeeldingen, Pagina 57 van 62

tekeningen, modellen, programmatuur, verpakkingen, producten, stoffen of samenstellingen, medische hulpmiddelen, werkwijzen, processen, diensten, presentaties, lesmaterialen, uitvindingen en andere know-how en informatie in welke vorm dan ook (hierna genoemd “Onderzoeksresultaten”). 9.2

De Instellingen zijn verplicht ervoor te zorgen dat de Onderzoeksresultaten aan hun toekomen en zij zullen de Hartstichting op diens eerste verzoek kopieën van de Onderzoeksresultaten ter beschikking stellen. De Hartstichting is gerechtigd, met voorafgaande toestemming van de Instellingen, welke toestemming niet op onredelijke gronden zal worden onthouden, om de Onderzoeksresultaten onbeperkt te gebruiken en deze ter beschikking te stellen aan derden, voor niet commerciële doeleinden met een maatschappelijk en wetenschappelijk belang die behoren tot de aandachtsgebieden van de Hartstichting. De Hartstichting mag informatie uit goedgekeurde subsidieaanvragen, midterm-rapportages en eindrapportages (met uitzondering van de onderdelen daarvan die vertrouwelijk zijn) opnemen in haar onderzoeksinformatiesysteem en zij mag deze informatie openbaar maken onder meer via social media met inachtneming van het bepaalde in artikel 9.5). Totdat deze Onderzoeksresultaten door de betreffende Instelling(en) zijn gepubliceerd of een daarop betrekking hebbende octrooiaanvraag is ingediend, zal de Hartstichting deze Onderzoeksresultaten vertrouwelijk behandelen en niet gebruiken en/of aan derden kenbaar maken.

9.3

De Instellingen zullen ervoor zorgen dat alle intellectuele eigendomsrechten met betrekking tot de Onderzoeksresultaten, waaronder maar niet beperkt tot alle geregistreerde en niet geregistreerde intellectuele eigendomsrechten en aanvragen tot registratie daarvan, waaronder maar niet beperkt tot merkenrechten, octrooirechten, rechten op uitvindingen, databankrechten, auteursrechten (waaronder tevens begrepen rechten op software), modelrechten, domeinnamen en rechten op know-how (“Intellectuele Eigendomsrechten”) aan hun toekomen. De Hartstichting is gerechtigd, met voorafgaande toestemming van de Instellingen, welke toestemming niet op onredelijke gronden zal worden onthouden, tot het gebruik van de Intellectuele Eigendomsrechten, voor de gebruiksdoeleinden zoals omschreven in artikel 9.2 welke gebruiksrecht de Hartstichting hierbij aanvaardt. De Hartstichting is gerechtigd, met voorafgaande toestemming van de Instellingen, welke toestemming niet op onredelijke gronden zal worden onthouden, sublicenties te verlenen aan derden voor het gebruik van de Intellectuele Eigendomsrechten, voor de gebruiksdoeleinden zoals omschreven in artikel 9.2 welke recht de Hartstichting hierbij aanvaardt.

9.4

Indien een van de Instellingen (een deel van) de Onderzoeksresultaten en/of Intellectuele Eigendomsrechten overdraagt aan een derde, dan is zij verplicht tezamen met deze Onderzoeksresultaten en/of Intellectuele Eigendomsrechten tevens het gebruikrecht bedoeld in artikel 9.2 en de licentie bedoeld in artikel 9.3 over te dragen aan deze derde en zal zij bedingen dat de derde dezelfde verplichting op grond van dit artikel door middel van een kettingbeding tevens zal opleggen aan opvolgende verkrijgers.

9.5

Indien (een deel van) de Onderzoeksresultaten in aanmerking kom(t)en voor octrooibescherming, zal de betreffende Instelling de Hartstichting daarvan zo spoedig mogelijk in kennis stellen. De Instellingen, de Onderzoekers en de Hartstichting zijn ervoor verantwoordelijk dat geen van deze Onderzoeksresultaten openbaar gemaakt worden, voordat een octrooiaanvraag is ingediend.

Pagina 58 van 62

9.6

Een Instelling zal, indien door haar en/of een derde een octrooiaanvrage wordt ingediend met betrekking tot (een deel van) de Onderzoeksresultaten, onverwijld aan de Hartstichting mededelen op wiens naam de octrooiaanvrage is ingediend en wat de datum en het volgnummer van de octrooiaanvrage zijn. De Instelling zal ervoor zorgen, daar waar mogelijk, dat de Hartstichting in het octrooischrift wordt vermeld als subsidieverlener. De Instelling zal bij overdracht van (een deel van) de Onderzoeksresultaten aan een derde dezelfde verplichting opleggen aan deze derde en zal daarbij bedingen dat deze derde dezelfde verplichting door middel van een kettingbeding tevens zal opleggen aan opvolgende verkrijgers van de Onderzoeksresultaten.

9.7

De Instellingen erkennen dat een deel van de Revenuen voortvloeiend uit het Onderzoeksproject ten goede zou moeten komen aan de Hartstichting. De Instellingen zullen jaarlijks 17% van de NettoRevenuen, betalen aan de Hartstichting. De Instellingen zullen de Hartstichting onverwijld informeren indien zij dergelijke Netto-Revenuen hebben gegenereerd en zullen de relevante documentatie voor de onderbouwing van de hoogte van die bedragen, op eerste verzoek van de Hartstichting, overleggen. De Instellingen zijn gehouden om hun administratie zodanig in te richten dat er eenduidig inzicht is in de Kosten en Revenuen. De Hartstichting is gerechtigd om op haar eigen kosten een audit te laten uitvoeren, door een door haar aan te wijzen externe accountant, om de juistheid en de volledigheid van de Revenuen, Kosten en opgegeven Netto-Revenuen te controleren. Indien uit een dergelijke audit blijkt dat de daadwerkelijk gerealiseerde Netto-Revenuen meer dan 3% hoger zijn dan de opgegeven Netto-Revenuen, dan zal de betreffende Instelling de kosten voor de audit vergoeden en zal zij het verschil tussen de daadwerkelijk gerealiseerde Netto-Revenuen en de opgegeven NettoRevenuen alsnog betalen aan de Hartstichting.

10. 10.1

Overige verplichtingen Instellingen De Instellingen staan ervoor in dat ook andere bij het Onderzoeksproject betrokken (rechts)personen de door de Hartstichting aan de verlening van de Subsidie verbonden verplichtingen zullen naleven en dragen er zorg voor dat deze verplichtingen ook bindend aan alle aan het Onderzoeksproject deelnemende (rechts)personen worden opgelegd. Schending van één van deze verplichtingen door één of meer van de deelnemende (rechts)personen, wordt beschouwd als een schending van deze Definitieve overeenkomst door de Instellingen.

11.

Vrijwaring

11.1

De Instellingen vrijwaren de Hartstichting en stellen de Hartstichting schadeloos ten aanzien van alle (directe en indirecte) schade en kosten voortvloeiend uit of verbandhoudend met vorderingen en aanspraken van derden uit welke hoofde dan ook, waaronder mede begrepen vorderingen wegens inbreuk op intellectuele eigendomsrechten van derden of vorderingen wegens productaansprakelijkheid, tenzij de vorderingen en aanspraken zijn te wijten aan gebruik van de Onderzoeksresultaten en de Intellectuele Eigendomsrechten door de Hartstichting of haar licentienemers, in welk geval de Hartstichting de Instellingen zal vrijwaren en schadeloos stellen ten Pagina 59 van 62

aanzien van alle (directe en indirecte) schade en kosten voortvloeiend uit dit gebruik. 12.

Duur en beëindiging

12.1

De Definitieve overeenkomst heeft een looptijd van 5 jaren met ingang van ..-..2016 t/m ..-..2021.

12.2

De Hartstichting heeft het recht om de Definitieve overeenkomst met onmiddellijke ingang te beëindigen, de betaling van de Subsidie op te schorten en/of reeds gedane betalingen terug te vorderen van de Instellingen, een en ander ter hare keuze, onverminderd het recht van de Hartstichting om schadevergoeding te vorderen, indien naar het oordeel van de Hartstichting: (a) de wijze van uitvoering van het Onderzoeksproject door een van de Instellingen niet voldoet aan de daaraan door de Hartstichting gestelde eisen en deze Instelling de gebreken niet binnen een termijn van 30 dagen na schriftelijke ingebrekestelling door de Hartstichting heeft opgelost; (b) het Onderzoeksproject door een van de Instellingen niet volgens de Subsidieaanvraag wordt uitgevoerd en deze Instelling de gebreken niet binnen een termijn van 30 dagen na schriftelijke ingebrekestelling door de Hartstichting heeft opgelost; (c) de midterm- of eindrapportage niet voldoet aan de daaraan te stellen eisen en de Onderzoeksleider de gebreken niet binnen een termijn van 30 dagen na schriftelijke ingebrekestelling door de Hartstichting hebben opgelost; (d) het Onderzoeksproject wordt beëindigd voor het verstrijken van de looptijd van de Definitieve overeenkomst; (e) een van de Instellingen te kort schiet in de nakoming van haar verplichtingen uit hoofde van de Definitieve overeenkomst en deze Instelling de gebreken niet binnen een termijn van 30 dagen na schriftelijke ingebrekestelling door de Hartstichting heeft opgelost.

12.3

De Definitieve overeenkomst eindigt met onmiddellijke ingang in geval van faillissement, (voorlopige) surseance van betaling, stillegging c.q. liquidatie van een van de Instellingen.

12.4

In afwijking van het bepaalde in artikel 12.2 en 12.3 van de Definitieve overeenkomst, zal de Hartstichting de Definitieve overeenkomst niet met alle Instellingen beëindigen, maar alleen met de betrokken Instelling(en), indien de overige Instellingen binnen 30 dagen na ontvangst van het bericht van de Hartstichting dat zij overweegt om de Definitieve overeenkomst te beëindigen een voorstel doet voor de voortzetting van het Onderzoeksproject zonder de betrokken Instelling en dit voorstel naar het oordeel van de Hartstichting bevredigend is.

12.5

Indien Onderzoeksleider 1 niet langer werkzaam is bij de Subsidie-ontvanger en hij in dienst treedt van, of anderszins verbonden wordt aan, een andere instelling in Nederland waar hij zijn functie als onderzoeksleider zal voortzetten, dan zal de Subsidie-ontvanger haar rechten en verplichtingen uit hoofde van de Definitieve overeenkomst overdragen aan de nieuwe instelling. Indien de nieuwe instelling geen medewerking verleent aan overdracht van de rechten is de Hartstichting gerechtigd om de Definitieve overeenkomst met onmiddellijke ingang te beëindigen. Verder zal de Subsidieontvanger het nog niet aan de andere Instellingen doorbetaalde deel van de Subsidie terugbetalen aan de Hartstichting, of, zulks ter keuze van de Hartstichting, dit bedrag rechtstreeks overmaken naar de nieuwe instelling.

Pagina 60 van 62

12.6

Indien na de afronding van het Onderzoeksproject niet de volledige Subsidie is besteed, dan zullen de Instellingen het restant terugbetalen aan de Hartstichting.

12.7

In geval van beëindiging van de Definitieve overeenkomst om welke reden dan ook, zullen de artikelen 1, 5.7, 7, 9, 10, 11 en 13.1 van de Definitieve overeenkomst onverkort van kracht blijven.

13. 13.1

Overige bepalingen De door de Hartstichting verleende Subsidie geeft geen recht op financiering van toekomstige aanvragen.

13.2

In alle correspondentie over het Onderzoeksproject met de Hartstichting, moet het in de aanhef genoemde CVON-nummer worden vermeld. Correspondentie die hier niet aan voldoet, neemt het de Hartstichting niet in behandeling.

13.3

Op deze Definitieve overeenkomst is het Nederlands recht van toepassing en alle geschillen zullen worden voorgelegd aan de bevoegde rechter te 's-Gravenhage.

14. 14.1

Bijlagen Alle hieronder genoemde bijlagen zijn aan deze Definitieve overeenkomst gehecht en maken daarvan onderdeel uit. 1.

Subsidieaanvraag (artikel 1.8.)

2.

Ondertekende intra-consortium agreement (artikel 2.5)

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Voor akkoord getekend: Drs. F. Italianer, directeur Nederlandse Hartstichting

………………………………..

Subsidie-ontvanger: ………………………………… Instelling 1: ………………………………… Instelling 2: ………………………………… Instelling 3: Instelling 4: …………………………………

Voor gezien van deze Overeenkomst en voor akkoord met artikel 4.2 t/m 4.3, artikel 5.1 t/m 5.8 artikel 6.1 t/m 6.3 artikel 7.1 t/m 7.3, artikel 8.1 t/m 8.4 en artikel 9.1 t/m 9.7: Onderzoeksleider : ........................................

Pagina 62 van 62