As part of their Lyme Innovation Accelerator (“LymeX”) partnership, the U.S. Department of Health and Human Services (“HHS”) and the Steven & Alexandra Cohen Foundation (“Cohen Foundation”) are sponsoring the LymeX Diagnostics Prize (“the Competition”). The Competition was designed and is administered by Luminary Labs (“Competition Administrator”) under contract with the National Aeronautics and Space Administration (NASA), and will be 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).

The following official rules, terms, and conditions apply to Phase 1 of the LymeX Diagnostics Prize and reference the official governing document for the Competition, which can be found here. Please read these official rules carefully before entering.

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. To be eligible to win a prize under the Competition, a Participant (whether an individual, group of individuals, or entity) —
    1. Shall have registered to participate in the Competition under the rules promulgated by HHS as published in this announcement;
    2. Shall have complied with all the requirements set forth in this announcement;
    3. In the case of a private entity, shall be incorporated in and maintain a primary place of business in the United States, and in the case of an individual, whether participating singly or in a group, shall be a citizen or permanent resident of the United States. However, Non-U.S. citizens and non-permanent residents can participate as a member of a team that otherwise satisfies the eligibility criteria. Non-U.S. citizens and non-permanent residents are not eligible to win a monetary prize (in whole or in part). Their participation as part of a winning team, if applicable, may be recognized when the results are announced.
    4. May not be a Federal entity or Federal employee acting within the scope of their employment;
    5. May not be a Federal employee of the Department of Health and Human Services (or any other component of HHS) acting in their personal capacity;
    6. May not be an employee of the Cohen Foundation, or of any HHS contractors participating in LymeX;
    7. If employed by a Federal agency or entity other than HHS (or any component of HHS) and acting outside the scope of their employment, should consult with an agency Ethics Official to determine whether the Federal ethics rules will limit or prohibit the acceptance of a prize under the Competition;
    8. May not be a judge of the Competition, or any other party involved with the design, production, execution, or distribution of the Competition or the immediate family of such a party (i.e., spouse, parent, step-parent, child, or step-child).
  2. Federal grantees may not use Federal funds to develop their Competition submissions unless use of such funds is consistent with the purpose of their grant award or cooperative agreement. Federal grantees who use Federal funds to develop their Competition submissions must also obtain written prior approval from the appropriate grants management or program officer and provide documentation of prior approval upon request by HHS.
  3. Federal contractors may not use Federal funds from a contract to develop their Competition submissions or to fund efforts in support of their Competition submissions.
  4. Submissions must not infringe upon any copyright or any other rights of any third party.
  5. By participating in the Competition, each Participant (whether an individual, group of individuals, or entity) agrees to assume any and all risks and waive claims against the Federal government and its related entities (as defined in the America COMPETES Reauthorization Act, as amended), except in the case of willful misconduct, for any injury, death, damage, or loss of property, revenue, or profits, whether direct, indirect, or consequential, arising from participation in the Competition, whether the injury, death, damage, or loss arises through negligence or otherwise.
  6. Based on the subject matter of the Competition, the type of work that it will possibly require, as well as an analysis of the likelihood of any claims for death, bodily injury, property damage, or loss potentially resulting from Competition participation, no Participant (whether an individual, group of individuals, or entity) participating in the Competition is required to obtain liability insurance or demonstrate financial responsibility in order to participate in the Competition.
  7. By participating in the Competition, each Participant (whether an individual, group of individuals, or entity) agrees to indemnify the Federal government, the Cohen Foundation (and its directors, officers, and employees), and the Competition Administrator against third party claims for damages arising from or related to Competition activities.
  8. A Participant (whether an individual, group of individuals, or entity) shall not be deemed ineligible because the Participant used Federal facilities or consulted with Federal employees during the Competition if the facilities and employees are made available to all Competition Participants on an equitable basis.
  9. By participating in the Competition, each Participant (whether an individual, group of individuals, or entity) warrants that they are 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 the Participant is aware. In addition, each Participant grants to HHS an irrevocable, paid-up, royalty-free nonexclusive worldwide license to reproduce, publish, post, link to, share, and display publicly (e.g., on websites) the abstract and any other non-proprietary submission content on the web or elsewhere. In addition, each Participant grants to the Cohen Foundation an irrevocable, paid-up, royalty-free nonexclusive worldwide license to reproduce, publish, post, link to, share, and display publicly (e.g., on websites) the abstract and any other non-proprietary submission content on the web or elsewhere.  Each Participant will retain all other intellectual property rights in their submissions, as applicable. To participate in the Competition, each Participant must warrant that there are no legal obstacles to providing the above-referenced nonexclusive licenses of the Participant’s rights to the Federal government. To receive an award, Participants will not be required to transfer their intellectual property rights to HHS, but Participants must grant to the Federal government and the Cohen Foundation the nonexclusive licenses recited herein.
  10. HHS reserves the right, in its sole discretion, to (a) cancel, suspend, or modify the Competition, and/or (b) not award any prizes if no entries are deemed worthy.
  11. Each Participant (whether an individual, group of individuals, or entity) agrees to follow all applicable federal, state, and local laws, regulations, and policies.
  12. Each Participant (whether an individual, group of individuals, or entity) participating in the Competition must comply with all terms and conditions of the rules, and participation in the Competition constitutes each such Participant’s full and unconditional agreement to abide by the rules. Winning is contingent upon fulfilling all requirements herein.

Entrant rules

  1. Participants to the Competition 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.
  2. Participants are free to discuss their submissions and their ideas or technologies that it contains with other parties, are encouraged to share ideas/technologies publicly, are encouraged to collaborate or combine with other teams to strengthen their solutions, and are free to contract with any third parties. Participants should be aware that any agreement signed or obligation undertaken in regard to their participation in the Competition that conflicts with the rules may result in disqualification of the Participant’s submission.
  3. Participants 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 the Competition Administrator or HHS required documents for electronic payment within 30 days of notification by the Competition Administrator or HHS will result in a disqualification of the winning entry.
  4. Participants 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 HHS and the Competition Administrator 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.
  5. Participants in 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 Cohen Foundation’s promotion of this Competition.
  6. Participants 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 Participants may deem necessary to create and enter a submission.
  7. Use of Marks: Except as expressly set forth in the rules, Participants 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.
  8. Individuals with disabilities who need accommodation or auxiliary aid in connection with the submission process should contact the person listed under “For Further Information Contact” in this announcement at least one week prior to the submission deadline. Participants who use a TDD or a TTY may call the Federal Relay Service (FRS), toll free, at 1-800-877-8339. If an accommodation or auxiliary aid to an individual with a disability is provided in connection with the submission process, the submission remains subject to all other requirements and limitations set forth in this announcement.

Publicity Release

By participating in the Competition, each Participant hereby irrevocably grants to HHS and Cohen Foundation 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 Cohen Foundation’s promotion of this Competition.

Disqualification

HHS and Cohen Foundation reserve the right in their discretion to disqualify any Participant 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 the rules; 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 Cohen Foundation reserve the right to seek damages and other remedies from any such person to the fullest extent permitted by law.

Notice to winner(s)

Attempts to notify Phase 1 winner(s) will be made using the email address associated with the Team Lead’s email account used to register on the Competition platform. HHS and Cohen Foundation, and the Competition Administrator, are not responsible for email or other communication problems of any kind.

If, despite reasonable efforts, a potential Phase 1 winner does not respond within three days of the first notification attempt regarding selection as a Phase 1 winner (or a shorter time as exigencies may require), or if the notification is returned as undeliverable to such Participant, that Participant may forfeit the Participant’s Phase 1 winner status and any associated prizes, and an alternate Phase 1 winner may be selected.

If any potential winner is found to be ineligible, has not complied with the rules, 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

  • ​​Each Participant also warrants that the work is free of security threats and malware.
  • Each Participant must clearly delineate any confidential commercial information contained in a submission that the Participant wishes to protect as proprietary data.
  • All materials submitted to HHS as part of a submission become HHS agency records. Any confidential commercial or financial information contained in a submission must be clearly designated at the time of submission.
  • If the submission includes any third party works (such as third party content or open source code), the Participant must be able to provide, upon request, documentation of all appropriate licenses and releases for use of such third party works. If the Participant cannot provide documentation of all required licenses and releases, HHS and Cohen Foundation reserve the right, at their sole discretion, to disqualify the submission.

Dates and deadlines

HHS and Cohen Foundation reserve the right to modify any dates or deadlines set forth in the announcement.

Competition termination

HHS and Cohen Foundation reserve the right to cancel, suspend, and modify the Competition, or any part of it, for any reason, at their sole discretion. HHS reserves the right not to award any prizes if no entries are deemed worthy.

General liability release

By participating in the Competition, each Participant hereby agrees that:

HHS, Cohen Foundation, (and its directors, officers, and employees) and the Competition Administrator shall not be responsible or liable for any losses, damages, or injuries of any kind (including death) resulting from participation in the Competition or any Competition-related activity, or from a Participant’s acceptance, receipt, possession, use, or misuse of any monetary prize.

The Participant, on behalf of the Participant, and the Participants’ successors, heirs, and executors, as applicable, expressly and irrevocably release HHS, Cohen Foundation (and its directors, officers, and employees), and the Competition Administrator from any claims of any nature, known or unknown, that the Participant may have or ever may have, arising out of Participant’s participation in the Competition, any Competition-related activity, or from Participant’s acceptance, receipt, possession, use, or misuse of any monetary prize. To the extent applicable, the Participant expressly waives all rights and benefits that the Participant may have under California Civil Code Section 1542 which states “A general release does not extend to claims which the creditor does not know or suspect to exist in his or her favor at the time of executing the release, which if known by him or her must have materially affected his or her settlement with the debtor” or similar law of any other jurisdiction. The Participant will indemnify, defend, and hold harmless HHS, Cohen Foundation, (and its directors, officers, and employees) and the Competition Administrator from and against all third-party claims, actions, or proceedings of any kind and from any and all damages, liabilities, costs, and expenses relating to, or arising from, the Participant’s participation in the Competition.

Without limiting the generality of the foregoing, HHS, Cohen Foundation, and the Competition Administrator 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.

The rules cannot be modified except by HHS and Cohen Foundation in their absolute discretion. The invalidity or unenforceability of any provision of the rules 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, the rules 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.

Privacy, data security, ethics, and compliance

Participants 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.

Participants 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 Participants 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: http://www.hhs.gov/ocr/privacy/index.html.

Summary of the HIPAA Privacy Rule: http://www.hhs.gov/ocr/privacy/hipaa/understanding/summary/index.html.

Summary of the HIPAA Security Rule: http://www.hhs.gov/ocr/privacy/hipaa/understanding/srsummary.html.

Human Subjects—HHS

Office for Human Research Protections: http://www.hhs.gov/ohrp/index.html.

Protection of Human Subjects Regulations: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html.

Policy & Guidance: http://www.hhs.gov/ohrp/policy/index.html.

Institutional Review Boards & Assurances: http://www.hhs.gov/ohrp/assurances/index.html.

Human Subjects—FDA

Clinical Trials: http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm.

Office of Good Clinical Practice: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/OfficeofScienceandHealthCoordination/ucm2018191.

Consumer Protection—Federal Trade Commission

Bureau of Consumer Protection: http://business.ftc.gov/privacy-and-security.

Exercise

The failure of HHS and Cohen Foundation to exercise or enforce any right or provision of the rules shall not constitute a waiver of such right or provision.

Governing law

All issues and questions concerning the construction, validity, interpretation, and enforceability of the rules 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; 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 Cohen Foundation; or the Competition Administrator’s local jurisdiction if a complaint is filed by any party against the Competition Administrator.

Privacy policy

By participating in the Competition, each Participant hereby agrees that occasionally, HHS and Cohen Foundation and the Competition Administrator may also use the Participant’s information to contact the Participant about federal Competition and innovation related activities, and acknowledges that the Participant has read and accepted the Privacy Policy published on the Competition website.

Additional participation terms

Please review the Luminary Lightbox Terms of Service at http://www.LuminaryLightbox.com/terms for additional rules that apply to participation in the Competition and more general use of the Competition website. Such Terms of Service are incorporated by reference into the rules. If there is a conflict between the Terms of Service and the rules, the latter terms shall control with respect to this Competition only.

Participation in the Competition constitutes the Participant’s full and unconditional agreement to the rules. By entering, a Participant agrees that all decisions related to the Competition that are made pursuant to the rules are final and binding, and that all such decisions are at the sole discretion of HHS and Cohen Foundation and the Competition Administrator.

Personal information collected from Participants to the Competition is subject to the Competition platform 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.