NFL HeadHealthTECH Challenge - Executive Summary

HeadHealthTECH Challenge VI:

SUBMIT YOUR PROPOSAL

Manager: Barry Myers, MD, PhD, MBA

For specific questions, email us at HeadHealthTECH@duke.edu

REQUEST DESCRIPTION:

Duke University's Clinical and Translational Science Institute (Duke CTSI) and Football Research, Inc. invite proposals for protective equipment and technology that can lead to significant gains in head protection. Specific focus areas for HeadHealthTECH Challenge VI include:

• Helmet technologies
• Surfaces that helmets contact, including turf, grass, other helmets, opponent shoulder pads and other padding, etc.

BACKGROUND:

Each year, the National Football League (NFL) and its affiliates and other partners receive proposals from institutions, individuals, and corporations interested in promoting safety. These proposals typically range from concepts to enabled ideas to reduced-to-practice technologies to commercially ready products for use by athletes. To appropriately evaluate these ideas, promote academic and industrial safety research, and catalyze product-focused injury prevention and treatment in football, Duke University's Clinical and Translational Science Institute (Duke CTSI) has been engaged for the purposes of accepting, evaluating, accelerating, and potentially assisting in the development of these promising opportunities. The program's goal will be to provide critically needed "value recognition" evidence to support promising opportunities, thereby increasing their likelihood of success while shortening the development time before these products positively affect the game. Support to such promising opportunities will be provided by FRI, a nonprofit corporation that receives its financial support from the NFL.

To continuously stimulate development in academia and the marketplace, FRI has developed an annually renewable grant program that will offer up to three challenges a year for up to the four years.

APPROPRIATE RESPONSES TO THIS CHALLENGE VI REQUEST

During TECH Challenge VI, proposals will be accepted from both public and private organizations. All proposals must be able to articulate a path by which they will successfully impact football player health and safety. In that regard, academic projects will require demonstrated support and commitment of their institution to agree to protect and license relevant intellectual property (IP) to an appropriate entity that will ensure continued advancement of the project following the funding period. Proposals that are intended to be executed commercially will be expected to describe either a fully developed or prospective financing strategy to bring products to market.

All types of protective equipment may apply in this TECH Challenge VI. These include designs and innovations in equipment and technology that can lead to head protection. The following are especially encouraged:

Improvements in helmet and/or the surfaces that helmets contact (e.g., turf, grass, other helmets, opponent padding, including shoulders, etc.);

Ready-to-deploy material advances;

Studies that define the range of exposures (e.g., location, speed of impact, frequency of impact) that can be used to improve test protocols for helmet development; and

Studies that elucidate the optimal stress strain properties of helmet materials.

Funded proposals may include requests for proof-of-concept studies through to on-field trials for developed technologies. The program is technology stage agnostic; however, successful proposals will likely include a description of sources of follow-on support (meaning sources of funds that will be required in excess of those funds provided by any of the HeadHealthTECH Challenges, including, without limitation, federal grants, internal funding, equity, licensing, marketing and strategic partnerships) necessary to advance the project from the current stage to on-field use. In addition, value-recognition studies that provide critical evidence to advance the project to follow-on support and projects that generate biomechanical evidence that can later be used to support the design of new equipment (i.e., kinematic measurement during impact, rotation of force calculation) or to give rise to new rules for play will be strongly considered.

SUBMISSION PROCEDURE:

Proposals are to be submitted via Duke's MyResearchProposal online submission system. To apply:

• Visit www.playsmartplaysafe.com/headhealthtech for an overview and instructions.
• Visit http://bit.ly/myresearchproposal and click on "Create New User" (or log in if already have an account). Proposals must be submitted under the Primary Investigator's name.
• Review the step-by-step user's guide for applying via the MyResearchProposal software, which is available in this document.
• Enter Access Code "NFL" then select the "HeadHealthTECHC6" funding opportunity and follow the instructions.
• For those wishing to submit NONCONFIDENTIAL materials for guidance and advice, please send questions to HeadHealthTECH@duke.edu.
• Proposal entered via MyResearchProposal software to include biosketches, budget, 5 page technical description and 4 page supplemental data description (optional).

Please address program questions to HeadHealthTECH@duke.edu.

If you are having trouble accessing the system, please send an email to: MyResearchProposal@duke.edu.

EVALUATION CRITERIA:

Duke CTSI and the Oversight Committee established jointly by Duke CTSI and FRI will assess the proposals using the following assessment criteria:

GENERAL CRITERIA

• Proposals must include a scope of work that is one year or less. Proposals will be funded for one year and are available for re-application during each year of the HeadHealthTECH Challenges
• Submitting party must demonstrate the technical feasibility of quarterly milestones that will be achieved during the funding period
• Proposal must include specific plans or proposals relating to follow-on funding
• Proposal must lay out a clear financing, licensing or go-to-market plan or proposal or otherwise describe how the funding will be used
• Proposal must include a description of resources of environment to achieve milestones
• Proposal must include the relevant background of the team/organization/lab submitting the response

RESPONDING TO THIS CHALLENGE:

By submitting a response, each submitting party agrees to all of the following submission requirements, including intellectual property, selection and the review processes:

INTELLECTUAL PROPERTY

Intellectual Property is owned and retained by the submitting party.

SELECTION AND REVIEW PROCESS

All judging, eligibility and award decisions are at the sole discretion of FRI and are deemed final and not subject to review or explanation.

The Oversight Committee will be convened to ensure relevant expertise and diversity of perspectives. The Committee will select and recommend projects to be approved and funded by Football Research, Inc. The purpose and the members of the Oversight Committee can be viewed here.

SUBMITTING PARTY ACKNOWLEDGMENT

The submitting party acknowledges that Duke CTSI, FRI, the NFL and their respective affiliates (collectively, the Sponsor Affiliates) deal with many companies, and receive many proposals, from companies whose business line or research and development operations are similar to or competitive with the business lines or research and development operations of the submitting party, and the occurrence, operation or existence of such competitive activities will not be a cause for any action or allegation by the submitting party that any Sponsor Affiliate has failed to observe any duties or agreements, whether or not set forth herein. In addition, the submitting party agrees to permit any Sponsor Affiliate to, at its sole discretion, (X) promote that the submitting party (among other parties) has submitted a proposal and (Y) announce any funding awarded.

AWARDS

The HeadHealthTECH Challenges are an annually renewable grant program that will offer up to three challenges a year for up to the next four years. For each year that the program is renewed, an aggregate amount of up to $1 million in direct funding awards will be provided by FRI (or such higher amount as agreed to in FRI's sole discretion). In addition to, or, in some cases, in lieu of, providing direct funding awards, interesting projects may receive in-kind support including expert biomechanical engineering consultation, completion of experimental studies, benchmarking against existing technology, creation of novel data to demonstrate utility, and access to on-field resources. All funding awards are a one-time offer and there is no offer of licensure, royalty or other financial compensation implied beyond the initial amount funded. Funded projects can and will be encouraged to apply for additional challenges if more than more year of funding is required.

ELIGIBILITY REQUIREMENT

To be eligible to submit a proposal, the submitting party will be required to agree to submission terms described in the Official Rules. To be eligible to receive any funding award, the applicable submitting party will need to sign a sponsor research agreement confirming, among other things, its eligibility qualifications and that it has complied with the Official Rules.

DEADLINES FOR THE 2018-2019 GRANT CYCLE:

YEAR 2 SOLICITATIONS (FOR CHALLENGES IV & V)

HeadHealthTECH Challenge V: Application period March – June 2018 with winners announced in October 2018

HeadHealthTECH Challenge VI: Application period July – September 2018 with winners announced in January 2019

HEADHEALTHTECH CHALLENGE II – EXPECTED TIMETABLE

Project update presentation to the Oversight Committee: July 2018

Final report due: October 2018

HEADHEALTHTECH CHALLENGE III – EXPECTED TIMETABLE

Second quarterly report due: September 2018

Project update presentation to the Oversight Committee: December 2018

Final report due: March 2019

HEADHEALTHTECH CHALLENGE IV – EXPECTED TIMETABLE

First quarterly report due: October 2018

Second quarterly report due: January 2019

Project update presentation to the Oversight Committee: March 2019

Final report due: June 2019

HEADHEALTHTECH CHALLENGE V – EXPECTED TIMETABLE

Review of proposals: July 2018

Oversight Committee will convene for the Oral Presentations in September 2018

Announce winners and launch projects: October 2018

First quarterly report due: January 2019

Second quarterly report due: April 2019

Project update presentation to the Oversight Committee: July 2019

Final report due: October 2019

HEADHEALTHTECH CHALLENGE VI – EXPECTED TIMETABLE

Initial announcement of Phase: July 2018

Proposals due: September 2018

Oversight Committee will convene for the Oral Presentations in December 2018

Announce winners and launch projects: January 2019

First quarterly report due: April 2019

Second quarterly report due: July 2019

Project update presentation to the Oversight Committee: October 2019

Final report due: January 2020

All dates are subject to change at the discretion of FRI and Duke CTSI.

PROGRAM CONTACTS:

For Duke CTSI, the program point persons will be:

• Barry Myers, MD, PhD, MBA, Director of Innovation, Duke CTSI; Coulter Program Director and Professor of Biomedical Engineering at Duke University and a consultant to the NFLPA
• Melissa Hall, Program Officer, Duke CTSI

Please address program questions to HeadHealthTECH@duke.edu.