Carolina KickStart Commercialization Award Program

Transcription

1 Carolina KickStart Commercialization Award Program Request for Applications Purpose The Carolina KickStart Commercialization Award program will provide funding and access to internal and external business experts to assist faculty-led companies with the commercialization of concepts for therapeutic small molecules, nanoparticles, macromolecules, novel delivery methods, diagnostics, devices or health IT. Eligibility The eligibility requirements are as follows: 1. The program is open to any company where the founder is a faculty member with a primary appointment at UNC-Chapel Hill, an appointment in the joint UNC-NCSU Biomedical Engineering (BME) department or faculty members of external NC TraCSaffiliated institutions who provide a letter of collaboration from a UNC-Chapel Hill faculty member. 2. Priority will be given to companies developing intellectual property (IP) owned by UNC- CH and disclosed to UNC-CH in the form of a Report of Invention (ROI). (If the IP resides at NCSU as part of the BME department, the applicant must provide information on the IP (ROIs, patent applications, etc.) to UNC-CH Office of Commercialization and Economic Development (formerly OTD). It is the applicant s responsibility to notify OCED staff prior to making the application to ensure the IP is in good standing (proper ROI, fillings, etc.). 3. Licensed IP or a license anticipated within 6 months of the Effective Date of Award 4. An incorporated company. 5. A non-faculty CEO (interim or otherwise) or business advisor. 6. A business strategy for commercializing the product or service. Note: a full business plan is not required. 7. All proposed studies must be completed within 9 months of the Award Date. No Cost Extensions are only allowed under extenuating circumstances and is subject to approval by Carolina KickStart. For technologies that do not meet these requirements, the proposal may be too early in development for this Award. Funding for these groups may be sought through the NC TraCS Pilot Award program, Transformative Technology program, or the Drugs, Devices & Diagnostics Development (4D) program. Discussion with Carolina KickStart staff can help make the determination as to the most appropriate funding and resource program.

2 Funding The Carolina KickStart Commercialization Award Program will make a limited number of awards of up to $50,000, with the number and size of the awards dependent upon the quality of the proposal received and availability of funds. Application Procedure Given the wide range of technologies and their stage of development, faculty or company representatives are strongly encouraged to contact Carolina KickStart prior to submitting an application. By contacting the program, a preliminary assessment of the appropriateness of a KickStart Commercialization Award for your project can be provided. Contact us via (carolinakickstart@unc.edu) or phone ( ). Confidentiality: At the applicants request, Carolina KickStart will make reasonable efforts to keep information provided in the pre-application confidential. A complete application must include: An Executive Summary (not to exceed 1000 words). Include summaries of sections 1-10 below. Complete Proposal (not to exceed 500 words for each section (1-10) below). If any section is not applicable to your company, please note Not Applicable. 1. Problem or Un-Met Need Please describe the problem(s) or un-met need(s) the company aims to solve. Include all relevant information such as who is affected by the problem, the magnitude of the problem, what the current solutions are for the problem. Tell us specifically what part of the problem the company is trying to solve. Tells us about your competitors or alternative ways the problem is solved today. 2. Solution Describe the product or service that is envisioned and how this product or service will solve the problem. In what stage of development is the product/service? 3. Technology In detail, describe the underlying technology that supports or enables the product or service. How is this technology innovative? Is it evolutionary or revolutionary? Describe the intellectual property position (ROI and/or patents filed and/or planned).

3 4. Market Briefly describe the market for the product or service. Include information on the market size, the market potential, and the segment of the market the company plans on pursuing. Describe a typical customer for company s product/service. 5. Company Briefly include details on the corporate structure of the company, including date of incorporation and registered state. Include details on current company capitalization and equity stakes. What is the current status of the company with respect to licensing the technology from the University? 6. Regulatory (as appropriate) Include details on the appropriate regulatory pathway for the product (e.g. NDA/BLA, 505(b)2, 510(k), etc.). If available, include proposals from outside vendors or consultants supporting your regulatory strategy 7. Team Describe the founders, current management and scientific team include short bios (no biosketches) on each team member. How will the current management team leverage their expertise to help grow the company? As appropriate, include past accomplishments (e.g. partnering deals, currently marketed or soon to be approved products). Include details about any advisors for the company 8. Impact Describe, in detail, how the Carolina KickStart Commercialization Award will impact future development and growth of the company. In particular, describe how the funded activities are on the critical path by showing how this funding moves the commercialization efforts to the next logical step. Has the company applied for funding through other sources that overlap with the current proposal? 9. Proposed Studies/Experimental Plan Summarize the Specific Aims and/or Study Objectives to be funded by the KickStart Commercialization Award. Include a timeline for initiation and completion of the Specific Aims. If Specific Aims are accomplished, what are the anticipated milestone / technology development outcomes. For each specific aim, include details on how the work will be completed, where the work will be performed (i.e. by the company, subcontract to collaborating academic lab, CRO), and risks to its completion.

4 Note: When completing the online application, the Proposed Studies/Experimental Plan can be uploaded as a pdf or typed into the text field. 10. Funding and Budget Justification What is the overall amount of funding requested? Include a detailed breakdown describing how the funds are intended to be used in support of the company. The budget breakdown should include at least the following information: 1. Activity The specific activity/experiment the funds will be applied to. (Below is a list of suitable expenses.) 2. Outcome/Milestone The specific commercial milestones to be achieved with the funding. 3. Funds Requested The amount of money requested for this specific activity. Please include any other funding/budget information that is relevant to this application and the work to be performed under this KSCA. Suitable expenses may include, but are not limited to, the following (Note limit on Operational Expenses): Operational Expenses (up to 30% of the requested budget) 1. Legal expenses such as funds for corporate legal services 2. Assessments of IP landscape (FTO, reviews, etc.) 3. Fund-raising activities 4. Creation of a business plan 5. Market research 6. Regulatory consultation 7. Securing incubator space 8. Intellectual Property fees and fillings Technology Commercialization Activities (70%) 1. Synthesize small molecule new chemical entities (NCEs) 2. Animal studies comparing novel drug to competitive drug 3. Produce tox/research grade biologics 4. Produce beta test platforms for diagnostics 5. Large scale trial to validate diagnostic test 6. Produce device prototypes 7. Validate commercial instruments for population/social research etc. An inadequate budget justification may result in a less favorable score and/or lower funding. Carolina KickStart staff can provide input on the budget justification.

5 Note: When completing the online application, Budget and Justification can be uploaded as a pdf or typed into the text field. 11. Letters of support from Non-UNC Chapel Hill principal investigators to document the collaborative relationship with UNC Chapel Hill. 12. If company research activities are conducted at UNC, appropriate documentation must be provided of a Facility Use Agreement in the case of company employees conducting research in any UNC facility. Supplementary Material (optional) The following optional materials should be uploaded as a single pdf. Complete business plan Up to 3 full publications Additional letters of support Relevant quotes from a third-party vendor Application Submission Applications are only accepted online through a web-based system. To access the application website, click the link below. Applications are due by 5pm on January 31 st or July 31 st. Confirmation of receipt of application will be sent within 5 business days of the deadline. CLICK HERE TO APPLY Note: If you have any trouble with the application system, us at carolinakickstart@unc.edu. Application Review 1. Each application will be reviewed, as appropriate, by the Carolina KickStart staff and an external Review Committee. The resulting preliminary recommendations will be passed on to the Carolina KickStart Steering Committee. 2. Research involving animals or human subjects must be reviewed in accordance with the University s general assurances and HIPAA. Projects involving human subjects must be submitted to an Institutional Review Board (IRB). 3. The Steering Committee will review the applications and preliminary recommendations and will make funding recommendations to the co-principal Investigators for NC TraCS.

6 Notification, Award Disbursement, and Terms 1. Notification of awards will be made generally within 6 weeks of the receipt date, with funding to commence shortly thereafter. 2. Projects should be completed in the time period designated in the approved application. 3. The funds will be administered under a collaborative agreement between the University and the company. 4. Disbursement of funds will be through the payment of company invoices provided to NC TraCS. The award may be tranched as appropriate and as determined by milestones set forth by the Steering Committee. 5. If company research activities are conducted at UNC, appropriate documentation must be provided as a Facility Use Agreement in the case of company employees conducting research in any UNC facility. 6. Final reports must be submitted to Carolina KickStart within 60 days of the award completion date, and will be reviewed by the Steering Committee. 7. Unexpended funds must be returned to the NC TraCS Institute. 8. Expenditures may begin at any time after the official start date, and must be expended according to budget statements submitted in the application. No-cost extensions are possible but rare. 9. As a condition of accepting KickStart Commercialization Award funds, award recipients shall be required to keep reasonable records detailing that KickStart Commercialization Award funds are spent according to requirements set forth in the award notification. These records must be submitted prior to the disbursement of subsequent tranches. 10. If the Company has not executed a license agreement with UNC for use of UNC intellectual property and if the intellectual property underlying the company is licensed to a third party at any time during the term of the commercialization award or prior to the final report, the Company must repay Carolina KickStart for any funds disbursed under this Award. Such payments are to be due 60 days after the date of such license to the third-party. 11. Further terms and conditions may be imposed by the Steering Committee from time to time and can be found at the Carolina KickStart web site.