Competition description

The Artificial Kidney Prize (the Competition) is a KidneyX competition to radically improve treatment options for people who may otherwise require dialysis or a transplant. The Competition was announced in September 2020, reflecting the Official Rules, Terms, and Conditions that follow; read the official challenge announcement here.

The Competition (October 2020 through October 2022) will award up to $10 million. Up to $4,000,000 in Phase 1 prizes will be distributed across up to eight (8) Phase 1 winners, at the discretion of HHS and ASN. For Phase 2, up to $6,000,000 in prizes will be distributed to winners at the discretion of HHS and ASN. Up to $2,500,000 in prizes will be awarded by HHS over Phases 1-2; up to $7,500,000 in prizes will be awarded by ASN over Phases 1-2. Eligibility to receive monetary prizes is further detailed in the Monetary Prizes section of these Official Rules, Terms, and Conditions. 

The deadline for Phase 1 submissions is 4:59 p.m. ET on March 24, 2021. (See Phase 1 below.)

The Competition will be conducted by the U.S. Department of Health and Human Services (HHS) and the American Society of Nephrology (ASN), collectively referred to as “HHS and ASN.” Luminary Labs, L.L.C. (Luminary Labs) has been contracted to assist and support HHS and ASN in organizing and managing the Competition. Activities conducted by Luminary Labs may also include providing technical assistance to potential entrants, entrants, and winners.

This prize competition is being run under the authority of section 24 of the Stevenson-Wydler Technology Innovation Act of 1980 (15 U.S.C. 3719), as added by the America COMPETES Reauthorization Act of 2010 (Pub. L. 111–358).

Phase 1

Phase 1 seeks demonstrated scientific and technical proofs of concept with detailed development plans for solutions that enable and advance the functionality, effectiveness, and/or reliability of artificial kidneys. For this competition, artificial kidneys may be wearable, implantable, bioengineered, developed as a xenotransplant or chimera organ, or other approaches not yet conceived.

In Phase 1 of the competition, integrated solutions are encouraged, but other innovative and impactful approaches that replace or regenerate kidney function, or compensate for loss of kidney function, will also be considered.

Entrants should refer to the Kidney Health Initiative’s 2018 Technology Roadmap for Innovative Approaches to Renal Replacement Therapy described in the challenge announcement for baseline design criteria. Proposed solutions should meet these requirements for any of the outlined options of an artificial kidney (e.g., wearable, implantable). General areas of interest include:

  • Continuous blood filtration with size-selective, non-clotting or non-fouling filters.
  • Continuous fluid and volume regulation assessment and automation.
  • Biologic solutions (as described in the KHI Technology Roadmap) that address the uremic state in order to reduce frequency or substantively delay the need for dialysis.
  • Size optimization and/or miniaturization to increase patient usability.
  • Solutions that enable integration of cellular and mechanical components.
  • Solutions that enhance the scalability and/or functional potential of regenerative technologies.
  • Novel xenotransplant or chimera-based approaches.
  • Sensors for diagnostic, volume management and cellular component uses, or for real time monitoring and feedback loops that enhance patient functionality and safety.
  • Vascular access and drainage constructs that successfully allow for miniaturization and low flow systems, which integrate seamlessly with the artificial kidney approaches above.
  • Other disruptive solutions, using approaches not specified above.

Below is an overview of Phase 1, which is open to all eligible entrants. In Phase 1:

  • Entrants are asked to submit component or integrated prototype solutions that enable and advance the functionality, effectiveness, and/or reliability of artificial kidneys. (See submission form for further details). 
  • Submissions open on October 30, 2020 and will close at 4:59 p.m. ET on March 24, 2021. 
  • Up to eight winners will be recommended by the judging panel according to official Phase 1 evaluation criteria (see evaluation criteria page for further details). The total Phase 1 prize of $4 million will be distributed among up to eight (8) Phase 1 winners, at the discretion of HHS and ASN.
  • Technical support available to entrants includes a range of informational resources to encourage and facilitate collaboration, navigate regulatory and commercial considerations, and incorporate patient input into solution development (see entrant resources for further information).
  • As part of their submission, Phase 1 entrants agree to have brief synopses or abstracts of their submissions published by the KidneyX partnership.

Phase 2

Phase 2 will be open to eligible entrants from Phase 1, as well as new eligible entrants who did not enter the first phase of the Competition. In Phase 2:

  • Entrants will be asked to submit an initial integration of prototype solutions into an artificial kidney, or already integrated prototype solutions that advance development of artificial kidneys. Submissions should be supported by pre-clinical (bench or animal) or clinical data demonstrating the potential of the prototype for successful support of the reliability, effectiveness and/or functionality of wearable and/or implantable artificial kidneys.. In their submission, entrants will be asked to provide justification for prototype design, and to include potential partners or collaborators that would enable artificial kidney development toward human clinical trials 
  • Submissions are anticipated to open in October 2021 and close in June 2022. 
  • Winners will be recommended by the judging panel according to official Phase 2 evaluation criteria. The total Phase 2 prize of $6 million will be distributed among Phase 2 winners, at the discretion of HHS and ASN.
  • Technical support will include a range of informational resources to encourage and facilitate collaboration, navigate regulatory and commercial considerations, and incorporate patient input into solution development.
  • As part of their Phase 2 submission, entrants agree to have brief synopses or abstracts of their concepts published by the KidneyX partnership.

Additional phases

At the discretion of HHS and ASN, additional phases of the Competition may follow Phase 2. These phases would build on the enabling solutions developed in Phases 1 and 2 of the Artificial Kidney Prize by calling for integrated, continuous artificial kidney solutions, accelerating their development, and advancing them toward human clinical trials. KidneyX hopes to secure a total prize of $200 million for all potential phases of the competition.

Eligibility

Pursuant to section 24 of the Stevenson-Wydler Technology Innovation Act of 1980 (15 U.S.C. 3719), as added by the America COMPETES Reauthorization Act of 2010 (Pub. L. 111–358):

  1. The Competition is open to all legal entities and individuals (non-felons) over the age of 18, subject to the additional eligibility requirements listed below. Eligibility is subject to verification by HHS and ASN before monetary prizes are awarded.
  2. An individual or entity shall have registered to participate in the Competition under the rules promulgated by HHS, ASN, and Luminary Labs in accordance with the description provided on the Competition website. Entrants shall have complied with all of the requirements on the official Competition website.
  3. Entrants are not eligible to receive any monetary or non-monetary prize in the Competition if they are a person or entity designated or sanctioned by the United States Treasury’s Office of Foreign Assets Control (see http://www.treasury.gov/resource-center/sanctions/SDN-List/Pages/default.aspx for additional information).
  4. Note on awards: Monetary prizes provided by ASN for the Competition will be awarded separately from HHS monetary prizes. Please refer to the “Monetary Prizes” section of these Official Rules, Terms, and Conditions for additional information on HHS and ASN prizes.
  5. HHS monetary prizes: To be eligible to win prize money from HHS under the Competition, a private entity shall be incorporated in and maintain a primary place of business in the United States; and an individual, whether participating singly or in a group, shall be a citizen or permanent resident of the United States. Note: Non-U.S. citizens and nonpermanent residents can participate as a member of a team that otherwise satisfies the eligibility criteria but will not be eligible to win a monetary prize from HHS (in whole or in part); however, their participation as part of a winning team, if applicable, may be recognized when results are announced.
  6. ASN monetary prizes: At the discretion of ASN, non-U.S. citizens/residents, or non-U.S. incorporated entities or places of business, may be eligible to receive certain monetary prizes awarded by ASN under the Competition.
  7. HHS and ASN employees directly supporting the development or execution of the Competition and support contractors directly supporting the development or execution of the Competition, Luminary Labs and its contractors (with the express exception of Luminary Labs’ authorized solver community), and judges are ineligible to compete in this Competition. Likewise, members of their immediate family (spouses, children, step-children, siblings, step-siblings, parents, step-parents), and persons living in the same household, whether or not related, are not eligible to participate in any portion of this Competition. Note: The members of an individual’s household include any other person who shares the same residence as such individual for at least three months out of the year.
  8. Individuals and entities, otherwise eligible to win a monetary or non-monetary prize, may form and submit a team entry; however, each team member must be clearly identified on the team’s submission form for the team to be eligible. Failure to follow this procedure as outlined on the Competition website will disqualify the contest submission. Team winnings, as determined by the Competition sponsor, will be distributed to the designated team lead for further distribution to team members. In the event 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. If the submission includes the work of any third party (such as third-party content or open source code). The entrant must identify the work and be able to provide, upon the request of HHS and ASN, and/or Luminary Labs, documentation of all appropriate licenses and released for such third-party works. If the entrant cannot provide documentation of all required licenses and relates, HHS and ASN reserve the right to disqualify the applicable submission, or direct the entrant to secure the licenses and relates for HHS and ASN’s benefit within three (3) days of notification of the missing documentation and allow the applicable submission to remain in the Competition.
  9. Entrants to this Competition must agree to be bound by the rules of the Competition, agree that the winner selection decisions for the Competition are final and binding, and acknowledge that their submissions may be the subject of a Freedom of Information Act (FOIA) request and that they are responsible for identifying and marking all business confidential and proprietary information in their submissions.
  10. Entrants selected as monetary prize winners must submit all required taxpayer identification and bank account information required to complete an electronic payment of the monetary prize. Failure to provide Luminary Labs, HHS, or ASN required documents for electronic payment within 30 days of notification by Luminary Labs, HHS, or ASN will result in a disqualification of the winning entry.
  11. Entrants in the Competition agree, as a condition for winning a monetary or non-monetary prize, to complete and submit all required winner verification documents to Luminary Labs, HHS, or ASN within 3 days of notification. Failure to return all required verification documents per return instructions by the date specified in the notification may be a basis for disqualification of the winning entry.
  12. Entrants to the Competition must agree and consent, as a condition for receiving a monetary or non-monetary prize, to the use of their name, affiliation, city and state, likeness or image, comments, and a short synopsis of their winning solution as a part of HHS and ASN’s promotion of this Competition.
  13. Entrants must own or have access at their own expense to a computer, an Internet connection, and any other electronic devices, documentation, software, or other items that entrants may deem necessary to create and enter a submission.
  14. The following entrants (including any individuals participating as part of a team or entity) are not eligible regardless of whether they meet the criteria set forth above:
    1. Any HHS employee.
    2. Any Federal entity or Federal employee acting within the scope of his or her employment or otherwise prohibited by Federal law. Federal employees should consult their agency ethics officials to determine whether the federal ethics rules will limit or prohibit acceptance of a prize under the Competition. Note: Federal ethical conduct rules may restrict or prohibit federal employees from engaging in certain outside activities; any federal employee not excluded under this paragraph seeking to participate in this Competition outside the scope of employment should consult his/her agency’s ethics official prior to developing a submission
    3. Any individual or entity that used Federal funds to develop a submission, unless such use is consistent with the grant award, or other applicable Federal funds awarding document. If a grantee using Federal funds enters and wins this Competition, the monetary prize must be treated as program income for purposes of the original grant in accordance with applicable Office of Management and Budget Circulars. Federal contractors may not use Federal funds from a contract to develop a submission for the Competition, or to fund efforts in support of a Competition submission.
  15.  An individual or entity shall not be deemed ineligible under these eligibility rules because the individual or entity used Federal facilities or consulted with Federal employees during a Competition if the facilities and employees are made available to all individuals and entities participating in the Competition on an equitable basis.
  16. Each individual (whether participating singly or in a group) or entity (whether participating singly or in a group with other individuals and/or entities) agrees to follow all applicable federal, state, and local laws, regulations and policies.
  17. Use of Marks: Except as expressly set forth in the Competition Rules, Terms, and Conditions, entrants shall not use the names, trademarks, service marks, logos, insignias, trade dress, or any other designation of source or origin subject to legal protection, copyrighted material or similar intellectual property (“Marks”) of the organizers or other Competition partners, sponsors, or collaborators in any way without such party’s prior written permission in each instance, which such party may grant or withhold at its sole and absolute discretion.
  18. By participating in the Competition, each entrant represents, warrants, and covenants that entrants are the sole authors, creators, and owners of the submission; and that;
    1. The entrant’s submission:
      1. Is not the subject of any actual or threatened litigation claim
      2. Does not, and will not, violate or infringe upon the intellectual property rights, privacy rights, publicity rights, or other legal rights of any third party
      3. Does not, and will not, contain any harmful computer code (sometimes referred to as “malware,” “viruses,” or “worms”)
    2. The submission and entrant’s use of the submission does not, and will not, violate any applicable laws or regulations of the United States.
    3. An individual or entity that is determined to be on the GSA Excluded Parties List (www.sam.gov) is ineligible to receive a monetary or non-monetary prize award and will not be selected as a Competition winner.

Entrants must comply with and abide by these Official Rules, Terms and Conditions and the decisions of HHS and ASN which shall be final and binding in all respects. HHS and ASN and Luminary Labs reserve the right to disqualify any submission that HHS and ASN and/or Luminary Labs in their discretion, deem to violate these Official Rules, Terms and Conditions.

Monetary prizes

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.

Evaluation criteria

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 akp@asn-online.org, 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: akp@asn-online.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.

Publicity release

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.

Disqualification

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.

Competition termination

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.

Insurance

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:

HIPAA

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

Human Subjects—HHS

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

Human Subjects—FDA

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

Exercise

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.

Governing law

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.

Privacy policy

By participating in the Competition, each entrant hereby agrees that occasionally, HHS and ASN and Luminary Labs may also use the entrant’s information to contact the entrant about federal Competition and innovation related activities, and acknowledges that the entrant has read and accepted the Privacy Policy.

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. 

Luminary Labs collects personal information from entrants to the Competition. The information collected is subject to the Privacy Policy located here: http://www.LuminaryLightbox.com/privacy. 

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.

 

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