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Nano Startup Challenge in Cancer
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Definitions and FAQs on Challenge


Definitions
Seasoned Entrepreneur:  A person who has founded a Life Sciences, biomedical and/or health IT company; raised dilutive and/or non-dilutive capital for that company and have exited either successfully or unsuccessfully.  CAI prefers entrepreneurs that have tenure of at least five years in a start-up and also have had corporate experience.  If the entrepreneur had a successful exit (sold their company or had an IPO) in less than five years, this also qualifies as being a “seasoned entrepreneur.” Please note: an “entrepreneur in residence” typically does not meet these qualifications unless they meet the criteria outlined
  • Examples of Seasoned Entrepreneurs

Invention: means any discovery or invention that is or may be patentable or otherwise protected under Title 35, U.S.C., or any novel variety of plant that is or may be protectable under the Plant Variety Protection Act (7 U.S.C. 2321 et seq.) or is protectable under the equivalent laws of a foreign nation

Start-up (to qualify for a NIH license):
  1. has been in operation for less than five (5) years;
  2. less than fifty (50) employees;
  3. less than five million ($5M) in funding since incorporation
  4. is majority owned by individuals, hedge funds, or venture funds or by a company that is majority owned by individuals, hedge funds or venture funds

The National Institutes of Health (NIH): NIH is one of the 11 agencies that compose the United States Department of Health and Human Services (HHS) and is the primary agency of the United States government responsible for biomedical and health-related research.  The NIH is made up of 27 institutes and centers, each with its own specific research agenda

The Center for Advancing Innovation (CAI): CAI is a global public-private partnership non-profit corporation. CAI’s mission is to support, accelerate and increase the volume of knowledge and technology transfer, translational research, commercialization and entrepreneurship in various fields of research, including biomedical research, to make more research available to the world for educational and innovation purposes and to improve the economy, create a virtuous circle of innovation and positively impact world health

Translation of Nanotechnology in Cancer: The NCI has initiated a public-private industry partnership called Translation of Nanotechnology in Cancer (TONIC) to accelerate the translation and development of nanotechnology solutions for the early detection, diagnosis, and treatment of cancer. The TONIC consortium, made up of government entities, and pharmaceutical, biotechnology, and other healthcare-related companies, will work in parallel to the Alliance. The consortium seeks to evaluate promising nanotechnology platforms and facilitate their successful translation from academic research to the clinic, resulting in safe, timely, effective, and novel diagnosis and treatment options for patients
Team Member Definitions
Team Leader: Accountable for deliverables and the Challenge's single point of contact

Team Member: Responsible for deliverables

Mentor: Person who has domain expertise who actively works with the team on a daily basis as the team needs

Advisor: Person who has domain expertise and the team uses for Q&A sessions only

Collaborator: Organization that agrees to help support the team by; these include but are not limited to: seed funding organization, service companies  (e.g., legal, financial, etc.)

Please find definitions for terms such as "responsible" and "accountable" here


FAQs


Challenge Overall
What are the goals of the Challenge?  
Please find here the link to the Challenge goals

Will we have access to the inventors during the competition? 
Yes, via scheduled Q&A sessions hosted by CAI and NIH.  Q&A sessions will be conducted virtually via Skype, Video Conferencing or a join.me session.   If your team is unable to make the Q&A session, you may listen to the meeting afterwards.  CAI will provide a link to the Q&A sessions, to be accessed via CAI only.  These recordings will be confidential under the Challenge CDA.  Also, CAI will collect questions ahead of time and consolidate for the inventor.  The inventor will answer questions in the order he/she deems most important for the teams

How will the Challenge distinguish teams?
Challenge teams must create a team name following the template 'organization' - 'team leader's initials' where:
  • 'organization' - Organization of the Team Leader
  • 'team leader's initials' - Initials of the team leader.  This is to distinguish teams that are derived from the same organization
We also encourage but do not require teams to form unofficial team names to show their spirit and creativity

Can an Organization have more than one team? 
Yes, there is no limitation on the number of teams per organization

Can an Organization have more than one team per invention? 

Yes, there is no limitation. Please be aware that the Challenge judges will typically choose only one or two winners per invention

Can a team member participate on several invention teams? 
If the member is a Core team member, they may not participate on another team in any capacity.  However, Advisors, Mentors, and Collaborators may participate on any number of teams as long as there is a definitive role.  For example, CAI imagines that there may be some entrepreneurs that may participate on several teams from one Organization

Can we have more than three students on a team?  
Yes, there is no limit to how large your team can be, but must be a minimum of two students, post-docs, and/or medical students, etc.

Can any team member fill the discipline requirements?
Yes, the core team as well as mentors, advisors, and collaborators can fill team requirements for the four disciplines.  However at least one of the two graduate students must fill either the Business or Medical Scientific discipline.  Keep in mind that by definition, mentors, advisors and collaborators will commit less time in terms of Challenge deliverables.  Challenge teams will be evaluated based on their application of each discipline and their collective ability to execute deliverables

Can we change a team member after we are accepted into the Challenge?  
Yes, however, if you are changing a core team member or the entrepreneur, you will need the new team member fill out this form.  Also, you must indicate to the Challenge organizers that one of your members is being added/dropped out.

What assistance will the students receive from the Challenge facilitators?
CAI is facilitating and managing the Challenge and you will receive communications regarding the Challenge through CAI on behalf of NIH.  CAI's team will provide templates, tools and other resources.  CAI will also have an established mentoring methodology for the teams.  CAI will also serve as a mentor to the teams.  In addition to CAI’s team, CAI is also formulating a team of mentors that will be able to answer questions in different subject matter areas.  If you'd like to nominate a mentor or judge, please click here

Who is on the Challenge core team?
Please click here to view the Challenge core team

Will the summary of the technologies be available for students to look at by October 12th, 2016?  
Yes
Scope of Challenge
What is the scope of the Challenge?
A therapeutic focus in both nanotechnology and cancer

Is the Challenge limited to the US or is it international?
 
International

Is the Challenge limited to one state within the US? 
No.  This Challenge is global

How does this fit into iCorps program? 
Several Universities participating in the iCorps program will be participating in the Challenge.  They will use the guidelines specified by the iCorps program but adhere to CAI's timeline.  Other than this, there is no direct linkage to the iCorps program at present
Inventions
Who owns the inventions?  
NIH owns a selection of the inventions offered by the Challenge.  Teams are also allowed to bring in inventions owned by other organizations, but must undergo approval by the Challenge Hosts

Are there national and/or international patents on the NIH inventions in the Challenge?  
This varies by invention; however, the inventions either have patents granted on an international/US basis or patent applications have been filed

Will an option to the NIH invention be provided when the teams enter the Challenge? 
No.  This Challenge provides teams a real-life substantive, genuine experience that entrepreneurs in the world face every day

Are the winning teams guaranteed a license to their selected invention?
No.  Licenses are not guaranteed to teams and their selected invention.  Negotiations will need to occur in order to receive a licensing agreement.

Will known risks/weaknesses and strengths for the NIH inventions be disclosed? 
Yes, they are part of the invention description

Is there a chance that the invention might be licensed by another organization during the course of the Challenge? 
Yes, but the risk is remote. It is unusual for the NIH to have more than one license application for a patent family

About NIH inventions: while another potential licensee may put an exclusive licensing application forth during the course of the Challenge, the intent to grant an exclusive license must be posted in the Federal Register for at least 15 days.  Anyone can object (including Challenge participants) to the license by submitting a license application during the Federal Register notice period. Finally, Federal statutory and NIH’s Office of Technology Transfer policy requirements give preference to small US businesses; thereby further mitigating the risk that Challenge Teams have an invention pulled from under them.   The largest risk of an invention being licensed will occur during the business plan phase of the Challenge.
Entering the Challenge - Team Formation and Requirements
How many teams are accepted into the Challenge per invention? 
​Maximum of 10 for NIH Inventions; no limit for third-party inventions

Do students select the inventions for which they want to build a team? 
Yes.  CAI advises students to select an area of interest as well as an area in which they have some experience

Can we populate our LOI using the live system?
Yes, LOIs can be submitted here 

Is there a maximum number of LOIs that can be submitted per team? 
No, however, LOIs that put forth strong teams and meet CAI's criteria and minimally accepted team criteria will be immediately accepted into the Challenge so that the team can start to develop their business plan. CAI encourages teams to be prepared to submit their LOI on October 12th, 2015 so that they get considered first for a particular invention. LOIs can be submitted here
​
What are the team requirements? 
Please see our Eligibility and Rules

Are co-inventors who are no longer employees of the NIH allowed to participate as part of a team? 
Yes, subject to any requirements of the co-inventor’s current employer and NIH post-employment restrictions

Are NIH-funded labs able to be collaborators for our team?
​Yes.

Do teams need to be formed all from individuals from within the same state? 
No, team members can be from any state and country

Do the team members actually have to be part of the leadership team of the start-up? 
No, the team can put forth a management team that is separate and distinct from the team participating in the Challenge.  The management team, however, must be represented in the letters of incorporation for the start-up

Can new members of the team be added during the progression for the Challenge? 
Yes, as long as the CAI administrators are made aware of the additional team member, the role that they will play, etc.  Team members must be eligible as well, e.g., over 18 years old.  See eligibility requirements here.  Please contact Jonathan Lui at for any additions to your team

Do post-docs and medical students in residency count as “graduate students”?  
Yes

Are there any tools provided to help the students form teams? 
Yes, you may post contact information for your teams and potential team members.  You can see this list here

How do I know how many teams have been accepted for each invention?
A "ticker" beside each invention description can be found here.  CAI will indicate when no more LOIs will be accepted

How will I know if I've been accepted into the business plan portion of the contest?
You will receive an email from CAI stating that you have been accepted into the business plan portion of the contest

Business Plan Phase

Can a business model canvas be created in lieu of the business plan? 
Yes

Start-up Phase

How many Start-up Phase teams will there be for each invention? 
1-3

What happens if there is no start-up? 
All teams in the start-up phase will be required to incorporate a company. So, all teams that agree to be in the start-up phase should be serious about creating a new company

What constitutes a “winner” in the start-up phase of the Challenge?  
A business entity that has successfully negotiated a license to a Challenge invention and has also secured dilutive and/or non-dilutive seed funding

Can there be more than one start-up winner per invention? 
Yes, technically if all teams in the start-up phase of the Challenge put forth licensing applications for different fields of use, there could be three start-ups per invention resulting in 15-40 start-ups

Are winning teams guaranteed licenses to their respective technologies?
No.  Winners of the Challenge will still need to submit a complete license application, which will be granted by the discretion of the NIH

Can the start-ups also license other technology that might complement the invention they are using for the Challenge?  
Yes.  They should use whatever mechanism possible to allow them to have a high probability of a sustainable, successful start-up as long as they comply with the Challenge rules

How much will teams receive for winning Phase 3: Startup?
There is no prize other than the $2000 for winning Phase 2 provided by CAI.  Prizes will be awarded separately for NIH selected inventions versus external; no set number of prizes has been decided.  Teams may potentially receive additional funding from VC pitches organized through the Challenge

How will equity be allocated in the start-up? 
The management team or designated leaders of the management team will collectively make this decision.  Equity of up to or equal to 7.5% of each winning start-up will be granted to one of the challenge pharmaceutical supporters. Additionally, a board of advisors seat will be awarded to this external company (no fiduciary responsibility)

Does the Challenge team absolutely have to create a start-up? 
No, the Challenge team may find a start-up organization who may want to license the invention to augment their portfolio

What happens to the Challenge team if they find a potential licensee that has a start-up?  
The team may still win the “start-up medal of honor prize,” but equity in the company is at the discretion and based on the negotiation between the start-up team and the start-up company that already exists

University Requirements

What would you like of the Universities?  
  • Advertise
  • Create Teams
  • Potentially identify a leader to spear head the effort for the University
  • Integrate the Challenge to the best of your ability into your curriculum
  • Proactively provide feedback regarding how we can improve the Challenge
  • Collaborate with our team and others using the social media platform

What’s “in it” for the Universities?  
Many Universities are seeking to expand their entrepreneurship offerings for students.  CAI hopes that this platform serves as a platform to further augment and enhance the current entrepreneurship programs offered by the University.  In addition, CAI sees this competition creating “built-in” jobs for students and spurring economic growth within the region.  Many Universities would see this as a benefit as well given this is one of the ways they are able to attract students to enroll in the University. Also, many Universities would love to have a start-up success story; we hope that there is this opportunity with the NIH inventions selected.  Finally, CAI anticipates that this Challenge will provide Universities a platform to create cross-disciplinary teams across their University and collaborations in their state to further strengthen ties within the University and state

Funding

Are SBIR grants guaranteed by the NIH? 
No, they need to be applied for and go through the normal SBIR evaluation process.  The SBIR team at the NIH will be aware of Challenge team applications.  CAI encourages the teams to apply for SBIR grants as soon as their start-up is incorporated and they have necessary documentation

Is funding guaranteed for start-ups? 
No, CAI has connected with several potential funding organizations. If funding organizations have agreed to participate in the Challenge to evaluate start-ups that arise out of this Challenge, they are listed in the potential funding section of the website

Other Pointers

Creativity: CAI encourages creativity in every sense of the word to help your team have a high probability of a successful outcome and differentiate yourself, while abiding by the “rules” of the Challenge

Branding: Remember to also be aware of branding. Many biomedical companies have names that seem obscure and do not relate to anything the end user can relate to. Challenge participants may differentiate yourself if you choose a name that end users can actually relate to.  Also, be sure to include imagery and tag lines and potentially even a jingle and mascot

Stakeholder Engagement:  Remember to include Key Opinion Leaders (KOLs), patient advocate groups, doctors (contemporary and more traditional), venture funds/private equity/angel investors, other inventors, etc.

Due Diligence: Please perform your own due diligence on the inventions in the challenge

NIH Licensing Process and Forms: Please familiarize yourself with the licensing process, the startup licensing agreements as well as the model licensing agreements for NIH inventions if your team chooses to select an invention from their portfolio
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