For Phases 1 and 2 of the Competition, up to $10,000,000 in total prize funds are available. HHS will award up to $2,500,000 in prizes during Phases 1-2, and ASN will separately award up to $7,500,000 in prizes during Phases 1-2.
The total monetary prizes for Phase 1 of the Competition will be up to $4,000,000. The judging panel will recommend up to eight (8) monetary prize winners according to official Phase 1 evaluation criteria. The Phase 1 monetary prizes will be distributed among the Phase 1 winners. Contestants to the Competition must agree and consent, as a condition for receiving a monetary prize, to the use of their name, affiliation, city and state, likeness or image, and an abstract of their winning solution as a part of HHS and ASN’s promotion of this Competition, as stated in the Eligibility and Publicity Release sections of these Official Rules, Terms, and Conditions.
If any potential winner is found to be ineligible, has not complied with the Official Rules, Terms and Conditions, or declines the monetary prize for any reason prior to award, an alternate winner may be selected.
The total monetary prizes for Phase 2 of the Competition will be up to $6,000,000. The judging panel will recommend winners according to official Phase 2 evaluation criteria. The Phase 2 prizes will be distributed among Phase 2 winners, at the discretion of HHS and ASN.
Monetary prizes awarded under Phases 1 and 2 will be paid by electronic funds transfer and may be subject to local, state, and/or Federal income taxes. HHS and ASN will comply with the Internal Revenue Service withholding and reporting requirements, where applicable. Prizes offered by ASN will be paid directly by ASN to prize recipients, and prize money offered by HHS will be paid directly by HHS to prize recipients. If ASN fails to pay any portion of the monetary prize it has indicated it intends to pay, HHS does not have the legal authority to pay the amount on their behalf.
A multidisciplinary judging panel will evaluate eligible Phase 1 submissions; depending on the volume of submissions received, an expert panel may conduct an initial review of eligible submissions and determine a subset for judge evaluation. Selected solutions will then advance to the judging panel. Submissions will be evaluated using the following equally-weighted criteria:
- Functionality replication: The degree of confidence in the enabling solution to safely replace or support one or more kidney functions, and the ability to sustain continuous functionality over time. (See the Kidney Health Initiative’s 2018 Technology Roadmap for Innovative Approaches to Renal Replacement Therapy for specific targets by functionality.)
- Integration potential: The degree to which the submission demonstrates potential utility in serving as a foundational enabling element of an artificial kidney, and clearly outlines plans to collaborate with other innovators and experts in further development.
- Technical maturity: The likelihood based on bench or animal testing results or other justification that the enabling technology could integrate with nascent artificial kidney solutions or receive approval to begin first-in-human clinical trials within 3-4 years from submission.
- Patient impact: The potential for the solution to improve quality of life and clinical outcomes for a broad spectrum of patients (e.g., those with differing access to care, comorbidities).
- Innovation: The level of advancement beyond established scientific methods and technology (e.g., advances in materials, biocompatibility, power utilization, size/weight, sensors, long-term patency).
- Development progress and plan: The amount of progress completed relative to funding received, the rigor of plans for continued development in Phase 2, and the confidence in the team to execute.
- Commercial viability: The potential and timeframe for the enabling solution as part of an integrated artificial kidney to attract external investment, be produced sustainably at scale, and obtain payer reimbursement once commercialized.
To achieve KidneyX programmatic goals, ASN and HHS may consider the diversity of solutions when selecting winners from the top-scoring submissions recommended by the judging panel.
Registration and submission requirements for Phase 1
To enter the Competition, entrants must go to the Competition website and complete all required fields of the Competition registration and submission form on the Competition website before the close of open submissions on March 24, 2021. Each entrant must complete all of the required fields in the Competition registration and submission form in accordance with these Official Rules, Terms and Conditions.
All entrants are required to provide consent to these Official Rules, Terms and Conditions upon submitting an entry. Submissions must be received during the open submissions period of the Competition in order to be eligible. Open submissions officially begin on October 30, 2020. Open submissions will last from Competition launch through the close of open submissions, currently scheduled for 4:59 p.m. ET on March 24, 2021. Luminary Labs is the official timekeeper for the Competition. Once submitted, a submission may not be altered during open submissions. HHS and ASN, and Luminary Labs reserve the right to disqualify any submission that HHS and ASN, or Luminary Labs deem inappropriate.
Individuals and entities, otherwise eligible to win a monetary prize, may form and submit a team entry. Each team member must be clearly identified on the team’s submission form for the team to be eligible. Team winnings will be distributed to the designated team lead for further distribution to team members. In the event that a dispute regarding the identity of the entrant who actually submitted the entry cannot be resolved to HHS and ASN’s satisfaction, the affected entry will be deemed ineligible.
All entry information submitted on the Competition website and all materials, including any copy of the submission, becomes the property of HHS and ASN and will not be acknowledged or returned by Luminary Labs, or HHS and ASN; however, entrants retain ownership of their concepts, including any software, designs, research, or other intellectual property (IP) that they develop in connection therewith, subject to the license granted to HHS and ASN to use submissions as set forth in the Intellectual Property of Submissions section of these Official Rules, Terms, and Conditions.
Proof of submission is not considered proof of delivery to or receipt of such entry. Furthermore, HHS and ASN, and Luminary Labs shall have no liability for any submission that is lost, intercepted, or not received by HHS and ASN, and/or Luminary Labs. HHS and ASN and Luminary Labs assume no liability or responsibility for any error, omission, interruption, deletion, theft, destruction, or unauthorized access to, or alteration of submissions.
Open submissions close at 4:59 p.m. ET on March 24, 2021. Entrants should submit at least one hour before the deadline to ensure the completed submission is received. Entrants who submit an application after the deadline date because of a technical problem with the Competition website system must immediately contact email@example.com, and provide an explanation of the technical problem experienced on the Competition website system. HHS and ASN, and Luminary Labs will accept your application if HHS and ASN and Luminary Labs can confirm that a technical problem occurred with the Competition website system and that the technical problem affected your ability to submit an application by March 24, 2021. HHS and ASN and/or Luminary Labs will contact you when a determination is made on whether the application will be accepted.
Note: These extensions apply only to the unavailability of, or technical problems with, the Competition website system. HHS and ASN will not grant an entrant an extension if the entrant failed to submit an application in the system by the application deadline date and time, or if the technical problem experienced is unrelated to the Competition website system.
Individuals with disabilities who need an accommodation or auxiliary aid in connection with the application process should contact: [Luminary Labs, 61 Broadway, Suite 2800, New York, NY 10006] or by email: firstname.lastname@example.org. Entrants who use a TDD or a TTY may call the Federal Relay Service (FRS), toll free, at 1-800-877-8339. If Luminary Labs provides an accommodation or auxiliary aid to an individual with a disability in connection with the entry submission process, the entry remains subject to all other requirements and limitations in these Official Rules, Terms, and Conditions.
By participating in the Competition, each entrant hereby irrevocably grants to HHS and ASN and Luminary Labs the right to the use of their name, affiliation, city and state, likeness or image, and a short synopsis of their winning solution as a part of HHS and ASN’s promotion of this Competition, as stated in the Eligibility section of these Official Rules, Terms, and Conditions.
HHS and ASN reserve the right in their discretion to disqualify any entrant who is found to be tampering with the entry process or the operation of the Competition, the Competition website, or other Competition-related websites; to be acting in violation of these Official Rules, Terms and Conditions; or to be acting in an unsportsmanlike or disruptive manner, or with the intent to disrupt or undermine the legitimate operation of the Competition; or to annoy, abuse, threaten, or harass any other person; and HHS and ASN reserve the right to seek damages and other remedies from any such person to the fullest extent permitted by law.
Links to third-party websites
The Competition website may contain links to third-party websites that are not owned or controlled by HHS and ASN or Luminary Labs. HHS and ASN and Luminary Labs do not endorse or assume any responsibility for any such third-party sites. If you access a third-party website from the Competition website, you do so at your own risk and expressly relieve HHS and ASN and / or Luminary Labs from any and all liability arising from use of any third-party website content.
Notice to winner(s)
Attempts to notify Phase 1 and Phase 2 winner(s) will be made using the email address associated with the Team Lead’s Luminary Lightbox™ account. HHS and ASN and Luminary Labs are not responsible for email or other communication problems of any kind.
If, despite reasonable efforts, a potential Phase 1 or Phase 2 winner does not respond within three (3) days of the first notification attempt regarding selection as a Phase 1 or Phase 2 winner (or a shorter time as exigencies may require), or if the notification is returned as undeliverable to such entrant, that entrant may forfeit the entrant’s Phase 1 or Phase 2 winner status and any associated prizes, and an alternate Phase 1 or Phase 2 winner may be selected.
If any potential winner is found to be ineligible, has not complied with these Official Rules, Terms and Conditions, or declines the applicable prize for any reason prior to award, such potential winners will be disqualified, and alternate winners may be selected.
Intellectual Property (IP) rights
Entrants retain all ownership in intellectual property of their submissions, subject to the licenses referenced herein.
- Entrants are free to discuss their submissions and their ideas or technologies that it contains with other parties, are encouraged to share ideas and technologies publicly, are encouraged to collaborate or combine with other teams to strengthen their solutions, and are free to contract with any third parties. Entrants should be aware that any agreement signed or obligation undertaken in regard to their participation in the Competition that conflicts with the Competition rules, terms, and conditions may result in disqualification of the entrant’s submission.
- By participating in the Competition, each participant (whether participating singly or in a group) warrants that he or she is the sole author or owner of, or has the right to use, any copyrightable works that the submission comprises, that the works are wholly original with the participant (or is an improved version of an existing work that the participant has sufficient rights to use and improve), and that the submission does not infringe any copyright or any other rights of any third party of which participant is aware. Each entrant is responsible for consulting with legal counsel of his/her/its choice as to whether publication of his/her/its abstract will jeopardize his/her/its ability to secure patent protection of his/her/its invention. Neither HHS nor ASN nor Luminary Labs shall be liable for any loss of IP rights or protection that results from publication of any entrant’s abstract by the KidneyX partnership. In addition, each participant (whether participating singly or in a group) and each entity grants to HHS an irrevocable, paid-up, royalty-free non exclusive worldwide license to reproduce, publish, post link to, share, and display publicly (e.g., on websites) the submission and related synopses or abstracts. To participate in the Competition, each entrant must warrant that there are no legal obstacles to providing the above-referenced nonexclusive licenses of participant rights to the federal government. To receive an award, winners must grant to the federal government a nonexclusive, non transferable, irrevocable, paid up license to practice, or have practiced for or on its behalf the solution throughout the world for federal purposes. Winners must also grant to the federal government and others acting on its behalf, a fully paid, nonexclusive, irrevocable, worldwide license in any copyrightable works that the submission comprises, including the right to reproduce, prepare derivative works, distribute copies to the public, and perform publicly and display publicly said copyrightable works. By participating in the Competition, each entrant hereby grants an irrevocable and royalty-free license to HHS and ASN and Luminary Labs to store, access, modify, reproduce, and distribute submissions in perpetuity. Each entrant also warrants that the work is free of security threats and/or malware.
- All materials submitted to HHS as part of a submission become HHS agency records.
- If the submission includes any third party works (such as third party content or open source code), the entrant must be able to provide, upon request, documentation of all appropriate licenses and releases for use of such third party works. If the entrant cannot provide documentation of all required licenses and releases, HHS and ASN reserve the right, at their sole discretion, to disqualify the submission.
Dates and deadlines
HHS and ASN reserve the right to modify any dates or deadlines set forth in these Official Rules, Terms and Conditions or otherwise governing the Competition.
HHS reserves the right to cancel, suspend, and/or modify this prize competition, or any part of it, for any reason, at HHS’s sole discretion. HHS reserves the right not to award any prizes if no entries are deemed worthy. ASN may also discontinue its participation in the prize competition at its discretion. If ASN elects to discontinue its participation, every effort will be made to announce that decision promptly on the KidneyX.org website.
General liability release
By participating in the Competition, each entrant hereby agrees that:
Without limiting the generality of the foregoing, HHS, ASN, and Luminary Labs are not responsible for incomplete, illegible, misdirected, misprinted, late, lost, postage-due, damaged, or stolen entries or prize notifications; or for lost, interrupted, inaccessible, or unavailable networks, servers, satellites, Internet Service Providers, websites, or other connections; or for miscommunications, failed, jumbled, scrambled, delayed, or misdirected computer, telephone, cable transmissions or other communications; or for any technical malfunctions, failures, difficulties, or other errors of any kind or nature; or for the incorrect or inaccurate capture of information, or the failure to capture any information.
These Official Rules, Terms and Conditions cannot be modified except by HHS and ASN in their absolute discretion. The invalidity or unenforceability of any provision of these Official Rules, Terms and Conditions shall not affect the validity or enforceability of any other provision. In the event that any provision is determined to be invalid or otherwise unenforceable or illegal, these Official Rules, Terms and Conditions shall otherwise remain in effect and shall be construed in accordance with their terms as if the invalid or illegal provision were not contained herein.
Based on the subject matter of the Competition and the type of work that it will possibly require, entrants are not required to obtain liability insurance or demonstrate financial responsibility in any specified amount for claims by a third party for death, bodily injury, or property damage or loss resulting from an activity carried out in connection with participating in a prize competition, but are encouraged to consult with their own advisors with respect to the level of insurance that is prudent for each entrant.
Privacy, data security, ethics, and compliance
Entrants are required to identify and address privacy and security issues in their proposed projects and describe specific solutions for meeting them. In addition to complying with appropriate policies, procedures, and protections for data that ensures all privacy requirements and institutional policies are met, use of data should not allow the identification of the individual from whom the data was collected.
Entrants are responsible for compliance with all applicable federal, state, local, and institutional laws, regulations, and policies. These may include, but are not limited to, Health Information Portability and Accountability Act (HIPAA) protections, Department of Health and Human Services (HHS) Protection of Human Subjects regulations, and Food and Drug Administration (FDA) regulations. If approvals (e.g., from an Institutional Review Board) will be required to initiate any activities associated with submission development in Phase 1 or 2 of the Competition, it is recommended that entrants apply for approval at or before that phase’s submission deadline. The following links are intended as a starting point for addressing potentially applicable regulatory requirements but should not be interpreted as a complete list of resources on these issues:
Main link: https://www.hhs.gov/hipaa/index.html.
Summary of the HIPAA Privacy Rule: https://www.hhs.gov/hipaa/for-professionals/privacy/laws-regulations/index.html
Summary of the HIPAA Security Rule: http://hhs.gov/hipaa/for-professionals/security/laws-regulations/index.html
Office for Human Research Protections: https://www.hhs.gov/ohrp/
Protection of Human Subjects Regulations: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule/index.html
Policy & Guidance:https://www.hhs.gov/ohrp/regulations-and-policy/guidance/index.html
Institutional Review Boards & Assurances: https://www.hhs.gov/ohrp/irbs-and-assurances.html
Clinical Trials: https://www.fda.gov/science-research/science-and-research-special-topics/clinical-trials-and-human-subject-protection
Office of Good Clinical Practice:https://www.fda.gov/about-fda/office-clinical-policy-and-programs/office-good-clinical-practice
Consumer Protection—Federal Trade Commission
Bureau of Consumer Protection: https://www.ftc.gov/about-ftc/bureaus-offices/bureau-consumer-protection/about-bureau-consumer-protection
The failure of HHS and ASN to exercise or enforce any right or provision of these Official Rules, Terms and Conditions shall not constitute a waiver of such right or provision.
All issues and questions concerning the construction, validity, interpretation, and enforceability of these Official Rules, Terms and Conditions shall be governed by and construed in accordance with U.S. Federal law as applied in the federal courts of the District of Columbia if a complaint is filed by any party against HHS and ASN, and the laws of the State of New York as applied in the New York state courts in New York City if a complaint is filed by any party against Luminary Labs.
Additional terms that are part of the rules, terms and conditions
Please review the Luminary Lightbox Terms of Service at http://www.LuminaryLightbox.com/terms for additional rules that apply to your participation in the Competition and more generally your use of the Competition website. Such Terms of Service are incorporated by reference into these Official Rules, Terms and Conditions. If there is a conflict between the Terms of Service and these Official Rules, Terms and Conditions, the latter terms shall control with respect to this Competition only.
Participation in the Competition constitutes the entrant’s full and unconditional agreement to these Official Rules, Terms and Conditions. By entering, an entrant agrees that all decisions related to the Competition that are made pursuant to these Official Rules, Terms and Conditions are final and binding, and that all such decisions are at the sole discretion of HHS and ASN and/or Luminary Labs.
Winner list, Official rules, and Contact
To obtain a list of winners (after the conclusion of the Competition) or a copy of these Official Rules, Terms and Conditions, send a self-addressed envelope with the proper postage affixed to: Luminary Labs, 61 Broadway, Suite 2800, New York, NY 10006. Please specify “Winner List” or “Rules, Terms and Conditions” and the name of the specific Competition in your request.