CONFIDENTIAL Project Application Form Chemelot InSciTe Project Application Form Version 5.0, 2015-08-06 CONFIDENTIAL Chemelot InSciTe Biomedical Application Form Document data Document key information 1.00 Title Version Owner Status Date 2014-01-27 Chemelot InSciTe Project Application Form Biomedical materials 4.00 Danielle Curfs final 2015-07-28 Document change history Version Date Author Section Nature of change 2.00 2.01 3.00 4.00 5.00 all all all all all Revisions in lay-out and wording Revisions in lay-out and wording Change of lay-out Update update 2014-04-15 2014-11-07 2014-11-07 2015-07-28 2015-08-06 D. Curfs D. Curfs E. Staring D. Curfs D. Curfs Related documents Document name Chemelot InSciTe Instructions for Biomedical project proposals Chemelot InSciTe Financial Guidelines Chemelot InSciTe Budget Sheet Chemelot InSciTe IP guidelines Chemelot InSciTe Project Agreement Date Description Owner 2015-07-28 D. Curfs 2015-04-15 Instructions for submitting a biomedical project proposal InSciTe financial guidelines 2015-06-26 2014-11-06 2015-07-01 Budget sheet for InSciTe projects IP guidelines for InSciTe projects Project Agreement M. Jeuken/ E. Staring M. Jeuken E. Staring E. Staring Stichting Chemelot InSciTe • Urmonderbaan 20F • 6167 RD Geleen • Netherlands • T +31 (46) 7022800 • info@chemelot-inscite.com www.chemelot-inscite.com • Trade Register 63001489 • VAT NL8550.48.645.B.01 • Rabobank NL05RABO3464288617 • BIC RABONL2U 2 CONFIDENTIAL Chemelot InSciTe Biomedical Application Form Introduction This project application form is designed for project proposals for the biomedical program of Chemelot InSciTe. Applicants submitting a project proposal are strongly advised to familiarize themselves with the Chemelot InSciTe objectives and additional information such as the organization, IP guidelines, budget sheet, financial guidelines etc. The questions in the project proposal form are designed to provide the applicants with the possibility to explain in detail why a project fulfils the criteria and should be executed within InSciTe. Each project application form is linked to a Project Leader (PL) and his/her email address. For each project, we ask the Project Leader to submit this form after reaching agreement with all applicants. Concerning the budget, an overview of the main project costs and contributions is required when submitting this form. Additionally, the details of the project budget must be provided in the project budget sheet. The project application form should be submitted together with the project budget sheet. Questions regarding the application of a project proposal or this form can be directed to Danielle Curfs, program manager biomedical Chemelot InSciTe, preferably via email at danielle.curfs@chemelot-inscite.com Use this document to submit your proposal. Your data should be added in the blue boxes. The required font type and size is Arial 10 pt. Line spacing is single. Submission deadline for the 2nd wave of project proposals is 6 November 2015. Completed forms are to be sent to Chemelot InSciTe by e-mail to danielle.curfs@chemelotinscite.com As a formal requirement, a signed hardcopy of this form together with the budget sheet are required in order to confirm submission of a proposal. The signed hardcopy should be send to: Chemelot InSciTe p/a Danielle Curfs Urmonderbaan 20F 6167 RD Geleen The Netherlands Stichting Chemelot InSciTe • Urmonderbaan 20F • 6167 RD Geleen • Netherlands • T +31 (46) 7022800 • info@chemelot-inscite.com www.chemelot-inscite.com • Trade Register 63001489 • VAT NL8550.48.645.B.01 • Rabobank NL05RABO3464288617 • BIC RABONL2U 3 CONFIDENTIAL Chemelot InSciTe Biomedical Application Form I. GENERAL INFORMATION This section of the project proposal gives information on title, project participants and subsidy possibilities. Max 2 A4. 1. Project title1 PLEASE ENTER HERE A PROJECT TITLE OF MAX 2 LINES 2. Project acronym Please enter here a project acronym of max 30 characters 3. Contact information of the Project Leader (PL) Name Please enter here the person acting on behalf of the Project Leader Name of organization Please enter here the organization being the PL Address Please enter here Street and number Please enter here Postal Code and City Telephone number Please enter here the telephone number Email address Please enter here the e-mail address 4. Contact information of the Participants’ Representative (PR) Name Please enter here the person acting on behalf of the Participants’ Representative Name of organization Please enter here the organization being the PR Address Please enter here Street and number Please enter here Postal Code and City Telephone number Please enter here the telephone number Email address Please enter here the e-mail address 5. Applicants Name enter name enter name enter name enter name enter name enter name Organization name enter organization enter organization enter organization enter organization enter organization enter organization Organization type Choose an item. Choose an item. Choose an item. Choose an item. Choose an item. Choose an item. Email address enter e-mail enter e-mail enter e-mail enter e-mail enter e-mail enter e-mail 1 In order to prevent the use of different fonts and point sizes, and to maximize the amount of information presentable, the number of char. is approximately 1 page A4 is 4,000 char. (ca. 600 words). Stichting Chemelot InSciTe • Urmonderbaan 20F • 6167 RD Geleen • Netherlands • T +31 (46) 7022800 • info@chemelot-inscite.com www.chemelot-inscite.com • Trade Register 63001489 • VAT NL8550.48.645.B.01 • Rabobank NL05RABO3464288617 • BIC RABONL2U 4 CONFIDENTIAL Chemelot InSciTe Biomedical Application Form Please be aware that for project applications in this this second wave, all projects must secure additional funding in addition to InSciTe funding, e.g. by participation of third parties (i.e. nonFounding Fathers) and/or by financial contributions from subsidies or other funding agencies. 6. Submission for other grant applications Have you submitted an application to or received a subsidy for this project or a part of this project? (e.g. from a government ministry, the “Netherlands Organization for Scientific Research” (NWO), Horizon 2020 etc.) Choose yes/no Grant name Grant description Please enter here the grant name Please enter here a grant description, max 10 lines Amount [k€] Please enter the amount of the subsidy in k€ If you have submitted an application or received a subsidy for this project or part of it, was this as part of the InSciTe project portfolio? Choose yes/no 7. Future opportunity for other grant applications Are you intending to submit this project or a part of this InSciTe project for external funding? Choose yes/no Grant name Please enter here the grant name Grant description: Please enter here a grant description, max 10 lines approach/strategy undertaken and requirements Submission date Decision date Amount [k€] Click here to enter a date. Click here to enter a date. Please enter the approximate amount of the possible subsidy in k€ Stichting Chemelot InSciTe • Urmonderbaan 20F • 6167 RD Geleen • Netherlands • T +31 (46) 7022800 • info@chemelot-inscite.com www.chemelot-inscite.com • Trade Register 63001489 • VAT NL8550.48.645.B.01 • Rabobank NL05RABO3464288617 • BIC RABONL2U 5 CONFIDENTIAL Chemelot InSciTe Biomedical Application Form II. KEY DATA AND SUMMARY OF THE PROJECT PROPOSAL This section gives information relevant for the InSciTe program management to obtain an overview of the project portfolio of InSciTe’s projects. Max 3 A4. 1. Executive Summary of the proposal Please enter here an executive summary of max 10 lines 2. Proposed start date 3. Duration of the project [months] 4. Total project costs (direct and indirect) [k€] Click here to enter a date. Enter duration in months Enter project costs in k€ NOTE: Project costs as calculated via the Budget Sheet 5. Research Area: Choose the Research Area to which your proposal belongs (only one should be selected): 1. Cardiovascular - with a (initial) focus on vessels 2. Orthopedic - with a (initial) focus on cartilage 3. Ophthalmology - with a (initial) focus on drug delivery 6. Key words Provide up to 5 key words for your proposal Please enter here maximal 5 key words 7. Publiekssamenvatting (Dutch) Please enter here the Dutch summary of max 10 lines; Deze samenvatting kan gebruikt worden voor communicatie doeleinden, bijvoorbeeld bij het informeren van een breder publiek o.a. patiëntenverenigingen over de activiteiten van Chemelot InSciTe o.a. via de Chemelot InSciTe website. De publiekssamenvatting moet voorzien zijn van een voor een breed publiek pakkende titel. De tekst moet voor de geïnteresseerde leek begrijpelijk zijn. Dus jargon moet worden omgezet naar normale Nederlandse termen. En uw verhaal moet zich op hoofdlijnen richten en mag dus wat “kort door de bocht zijn”. Stichting Chemelot InSciTe • Urmonderbaan 20F • 6167 RD Geleen • Netherlands • T +31 (46) 7022800 • info@chemelot-inscite.com www.chemelot-inscite.com • Trade Register 63001489 • VAT NL8550.48.645.B.01 • Rabobank NL05RABO3464288617 • BIC RABONL2U 6 CONFIDENTIAL Chemelot InSciTe Biomedical Application Form 8. Project HR organization - Please provide an HR organizational chart like the scheme below. The number of work packages is restricted to ≤5; sub-WPs are not allowed. 9. Possibility of Spin off projects Do you expect that spin-off projects might arise from the current project. Choose yes/no Comment If applicable give a comment of max 5 lines Stichting Chemelot InSciTe • Urmonderbaan 20F • 6167 RD Geleen • Netherlands • T +31 (46) 7022800 • info@chemelot-inscite.com www.chemelot-inscite.com • Trade Register 63001489 • VAT NL8550.48.645.B.01 • Rabobank NL05RABO3464288617 • BIC RABONL2U 7 CONFIDENTIAL Chemelot InSciTe Biomedical Application Form III. EXTENDED AND DETAILED PROJECT PROPOSAL In this section a more detailed scientific description of the project is required. 1. Project description Clinical need and problem definition (address all items separately, max 12,000 char.) 1) Background 2) Current international status of research in this field and the uniqueness of the current proposal 3) Aim, objective(s) and milestones of the project proposal, with a clear description of the expected clinical and technological breakthrough results including expected timeline towards clinical implementation 4) Plan of investigation 5) Preliminary results Please enter here the detailed project description, max 2 A4 1.a. Stichting Chemelot InSciTe • Urmonderbaan 20F • 6167 RD Geleen • Netherlands • T +31 (46) 7022800 • info@chemelot-inscite.com www.chemelot-inscite.com • Trade Register 63001489 • VAT NL8550.48.645.B.01 • Rabobank NL05RABO3464288617 • BIC RABONL2U 8 CONFIDENTIAL Chemelot InSciTe Biomedical Application Form 1. Project description 1.b. Detailed Working plan (address all items separately, max. 20,000 char.) 1) research per work package 2) milestones and deliverables per work package 3) number and type (e.g. PhD, PD) of researchers per work package Stichting Chemelot InSciTe • Urmonderbaan 20F • 6167 RD Geleen • Netherlands • T +31 (46) 7022800 • info@chemelot-inscite.com www.chemelot-inscite.com • Trade Register 63001489 • VAT NL8550.48.645.B.01 • Rabobank NL05RABO3464288617 • BIC RABONL2U 9 CONFIDENTIAL Chemelot InSciTe Biomedical Application Form 1. Project description 1.c. Provide a Gantt chart, including timelines and interdependency of the work packages (as described under 1. Project organization), milestones and deliverable(s) (max. 4,000 char.) 1. Project description 1.d. Describe potential clinical and technological hurdles that may inhibit successful completion of the project (max. 4,000 char.) Stichting Chemelot InSciTe • Urmonderbaan 20F • 6167 RD Geleen • Netherlands • T +31 (46) 7022800 • info@chemelot-inscite.com www.chemelot-inscite.com • Trade Register 63001489 • VAT NL8550.48.645.B.01 • Rabobank NL05RABO3464288617 • BIC RABONL2U 10 CONFIDENTIAL Chemelot InSciTe Biomedical Application Form 1. Project description 1.e. Describe the existing infrastructure at the partners that is necessary to conduct the research in the project (e.g. equipment, facilities) (max. 4000 char.) 1. Project description 1.f. If applicable, describe and justify the type and amount of animal and/or clinical studies included in this proposal (max. 4000 char.) 1. Project description 1.g. Will the project make use of any proprietary materials that require special agreements with their supplier/owner (e.g. license)? Stichting Chemelot InSciTe • Urmonderbaan 20F • 6167 RD Geleen • Netherlands • T +31 (46) 7022800 • info@chemelot-inscite.com www.chemelot-inscite.com • Trade Register 63001489 • VAT NL8550.48.645.B.01 • Rabobank NL05RABO3464288617 • BIC RABONL2U 11 CONFIDENTIAL Chemelot InSciTe Biomedical Application Form Please enter here background information, max 10 lines 1. Project description 1.h. Describe the use (incl. estimate of Hrs) of the InSciTe biomedical facilities. Clearly indicated which project members dedicate how much of their research activities in the InSciTe facilities (max. 4,000 char.) 1. Project description 1.i. Will investment in new equipment for the biomedical facility be necessary for the project execution? (Note: if this requires considerable effort it has to be part of the overall project plan e.g. as separate work package) Choose yes/no Stichting Chemelot InSciTe • Urmonderbaan 20F • 6167 RD Geleen • Netherlands • T +31 (46) 7022800 • info@chemelot-inscite.com www.chemelot-inscite.com • Trade Register 63001489 • VAT NL8550.48.645.B.01 • Rabobank NL05RABO3464288617 • BIC RABONL2U 12 CONFIDENTIAL Chemelot InSciTe Biomedical Application Form Costs [k€] please describe and justify investment Enter estimated equipment costs in k€ Enter investment description and justification, max 10 lines 2. Project team 2.a. Describe the specific roles and expertise of the partners in the project Please enter here the specific roles and expertise of the partners. Max 2 A4 2. Project team 2.b. Describe the current international position of the project partners with respect to the proposal (e.g. VSNU research assessment, market position) (max. 4000 char.) Stichting Chemelot InSciTe • Urmonderbaan 20F • 6167 RD Geleen • Netherlands • T +31 (46) 7022800 • info@chemelot-inscite.com www.chemelot-inscite.com • Trade Register 63001489 • VAT NL8550.48.645.B.01 • Rabobank NL05RABO3464288617 • BIC RABONL2U 13 CONFIDENTIAL Chemelot InSciTe Biomedical Application Form 3. Economic/Business value creation 3.a. 1) Describe how the project team will implement the results of this project. 2) Describe the new products, therapies and services that are expected to result from this project. Estimate their potential economic value. Base your estimate on the type of business model that is employed, the expected market size, market share, turnover, profit margin, etc. 3) Provide an indication of the additional budget and time needed to develop and market products resulting from this research project. 4) Describe the key assumptions and uncertainties underlying these projections. (address all items separately, max. 20,000 char.) 3. Economic/Business value creation 3.b. Address the benefits for the (Dutch) economy (e.g. by improved position in export, knowledge Stichting Chemelot InSciTe • Urmonderbaan 20F • 6167 RD Geleen • Netherlands • T +31 (46) 7022800 • info@chemelot-inscite.com www.chemelot-inscite.com • Trade Register 63001489 • VAT NL8550.48.645.B.01 • Rabobank NL05RABO3464288617 • BIC RABONL2U 14 CONFIDENTIAL Chemelot InSciTe Biomedical Application Form generation, contribution to knowledge infrastructure, new spin off companies, new jobs, additional industrial investments). (address all items separately, max. 18,000 char.) 3. Economic/Business value creation 3.c. Sketch the Intellectual Property (IP) landscape. Which opportunities for generating new IP are envisaged? Do issues with background IP exist? Stichting Chemelot InSciTe • Urmonderbaan 20F • 6167 RD Geleen • Netherlands • T +31 (46) 7022800 • info@chemelot-inscite.com www.chemelot-inscite.com • Trade Register 63001489 • VAT NL8550.48.645.B.01 • Rabobank NL05RABO3464288617 • BIC RABONL2U 15 CONFIDENTIAL Chemelot InSciTe Biomedical Application Form Please enter here the information on IP, max 20 lines 4. Clinical value creation 4.a. Describe how the consortium members will translate the results towards clinical implementation. (max. 4000 char.) 4. Clinical value creation 4.b. Describe the preclinical and clinical objectives and benefits as well as potential regulatory hurdles for clinical implementation. List the duration and phasing of preclinical phases.(max. 4000 char.) Stichting Chemelot InSciTe • Urmonderbaan 20F • 6167 RD Geleen • Netherlands • T +31 (46) 7022800 • info@chemelot-inscite.com www.chemelot-inscite.com • Trade Register 63001489 • VAT NL8550.48.645.B.01 • Rabobank NL05RABO3464288617 • BIC RABONL2U 16 CONFIDENTIAL Chemelot InSciTe Biomedical Application Form 4. Clinical value creation 4.c. Estimate the clinical value of the project results, and the impact on the cost effectiveness of the (Dutch) healthcare system. The estimate can be based on the interventions that will emerge Stichting Chemelot InSciTe • Urmonderbaan 20F • 6167 RD Geleen • Netherlands • T +31 (46) 7022800 • info@chemelot-inscite.com www.chemelot-inscite.com • Trade Register 63001489 • VAT NL8550.48.645.B.01 • Rabobank NL05RABO3464288617 • BIC RABONL2U 17 CONFIDENTIAL Chemelot InSciTe Biomedical Application Form from the project, the size(s) of the patient group(s) that are involved, possible savings in the healthcare sector when implementing the interventions, reduced hospitalization time, and improved health status and reduced burden of disease. Describe the key assumptions and uncertainties underlying this projection. (max. 4000 char.) 5. References and attachments List up to 20 key papers from project partners relevant to the proposal List up to 5 patents from project partners relevant to the proposal Stichting Chemelot InSciTe • Urmonderbaan 20F • 6167 RD Geleen • Netherlands • T +31 (46) 7022800 • info@chemelot-inscite.com www.chemelot-inscite.com • Trade Register 63001489 • VAT NL8550.48.645.B.01 • Rabobank NL05RABO3464288617 • BIC RABONL2U 18 CONFIDENTIAL Chemelot InSciTe Biomedical Application Form IV. PROJECT BUDGETING The estimate of the project costs consists of three parts: Personnel, Materials & services, Usage of equipment. Moreover, the project team needs to indicate whether investments in the InSciTe biomedical facilities are needed to execute the project. The overall project costs are calculated from the costs per Work Package. The information is used to determine if the project budget fulfils the basic InSciTe budget and funding rules. Details on budgeting will be evaluated based on the information provided in the Budget sheet, which must be completed and submitted with the proposal. Please make sure you have read and understood the InSciTe Financial Guidelines before you fill out the Budget sheet and the application form and please make sure the numbers provided below correspond fully to the calculated numbers in the Budget sheet. 1. Personnel Personnel costs: the total amount of personnel costs (including project personnel that works in the InSciTe facilities) invoiced to InSciTe by Founding Fathers (FF) and by third parties. The average amount of personnel costs per year must also be calculated. Please specify how the costs are divided year to year. 1.a. FTE’s Year Invoiced to InSciTe by FF Invoiced to InSciTe by others Total Total 1 2 Total 1 2 3 4 3 4 FTE FTE FTE 1.b. Euro’s Year Invoiced to InSciTe by FF Invoiced to InSciTe by others Total [k€] [k€] [k€] 2. Materials & services Please provide an estimate of materials & services needed for this project, other than regular materials & supplies which are included in the bench fees. These costs include CMR, animal studies and clinical trials. 2.a. Generic Requested materials & services Justification for request Cost [k€] Total amount requested [k€] Stichting Chemelot InSciTe • Urmonderbaan 20F • 6167 RD Geleen • Netherlands • T +31 (46) 7022800 • info@chemelot-inscite.com www.chemelot-inscite.com • Trade Register 63001489 • VAT NL8550.48.645.B.01 • Rabobank NL05RABO3464288617 • BIC RABONL2U 19 CONFIDENTIAL Chemelot InSciTe Biomedical Application Form 2.b. Animal studies Please provide an estimate of animal studies needed for this project. Specify amount of animals and species. Include these costs in the total amount of requested materials & services. Requested animal study Justification for Cost [k€] DEC approval [y/n] request 2c. Clinical studies Please provide an estimate of clinical trials for this project. Indicate expected amount of individuals needed. Include these costs in the total amount of requested materials & services. Requested clinical trials Justification for Cost [k€] MEC approval [y/n] request 3. Usage of equipment Please provide an estimate of the use of equipment needed for this project, in so far these costs substantially exceed the fees and overhead (which are meant to cover for existing infrastructure). These costs include third party costs. Costs can be charged on the basis of integral cost rates, excluding profit margins, which are used within your organizations. Rates may be subject to auditing by an (InSciTe) accountant. Requested usage of equipment Justification for Time [Hrs] Cost [k€] request 4. Investments needed for the InSciTe biomedical facility Please indicate whether execution of the project is dependent on investments in (specialized) dedicated equipment. Note. The personnel needed to operate this equipment should be part of the (project) budget. Requested investment Justification for request Cost [k€] Stichting Chemelot InSciTe • Urmonderbaan 20F • 6167 RD Geleen • Netherlands • T +31 (46) 7022800 • info@chemelot-inscite.com www.chemelot-inscite.com • Trade Register 63001489 • VAT NL8550.48.645.B.01 • Rabobank NL05RABO3464288617 • BIC RABONL2U 20 CONFIDENTIAL Chemelot InSciTe Biomedical Application Form 5. Project partner contributions Please indicate the contributions from the participants (Founding Fathers and/or third parties and/or subsidies). Specify the exact contribution each project partner offers. Founding Father: Name Total contribution[k€] total Third Parties: Name Total contribution[k€] total Subsidies: Name Total contribution[k€] total Stichting Chemelot InSciTe • Urmonderbaan 20F • 6167 RD Geleen • Netherlands • T +31 (46) 7022800 • info@chemelot-inscite.com www.chemelot-inscite.com • Trade Register 63001489 • VAT NL8550.48.645.B.01 • Rabobank NL05RABO3464288617 • BIC RABONL2U 21 CONFIDENTIAL Chemelot InSciTe Biomedical Application Form V. Signing Signature Project Leader Date Place Signature Name and position Signature Participants’ Representative Date Place Signature Name and position Stichting Chemelot InSciTe • Urmonderbaan 20F • 6167 RD Geleen • Netherlands • T +31 (46) 7022800 • info@chemelot-inscite.com www.chemelot-inscite.com • Trade Register 63001489 • VAT NL8550.48.645.B.01 • Rabobank NL05RABO3464288617 • BIC RABONL2U 22