Rules, terms, and conditions

To be eligible to win an award under the prize, an entrant:

1. Shall have registered to participate in the prize under the rules promulgated by Luminary Labs, (referred to as the “prize administrator”) as published in this announcement;
2. Shall be a legal entity (such as a non-profit, for-profit, or academic institution), and/or be represented by an individual with the delegated authority to act on behalf of that legal entity; The Primary Entrant must be a U.S.-based Concern at the time the Declaration of Intent is submitted and remain a U.S.-based Concern through the issuance of prize awards.
   1. “U.S.-based Concern” means:
      1. incorporated in the United States (including a U.S.-incorporated subsidiary even if the parent is foreign based), or
      2. unincorporated with its principal place of business in the United States. Principal place of business is defined as the primary location where management directs, controls, or coordinates the entity’s activities. 
   2. Note: Components of the work may be performed by a team consisting of subcontractors, consultants, CROs, or partner organizations, however, the Primary Entrant must retain responsibility for substantively leading the technical effort;
3. Shall have complied with all the requirements set forth in this announcement;
4. Shall not be a federal entity or represented by a federal employee acting within the scope of their employment;
5. Shall not include any employee of the Department of Health and Human Services (HHS, or any other component of HHS) acting in their personal capacity or professional capacity;
6. Shall not be a legal entity that is prohibited from transactions with or import into the United States, as designated or sanctioned by the United States Treasury’s Office of Foreign Assets Control (OFAC, see https://ofac.treasury.gov/sanctions-programs-and-country-information for additional information), or include any entities or individuals designated or sanctioned as such in OFAC’s List of Specially Designated Nationals and Blocked Persons at https://ofac.treasury.gov/faqs/topic/1631.
7. Shall not involve any judge of the prize, or any other party formally involved with the design, production, execution, or distribution of the prize or the immediate family of such a party (i.e., spouse, parent, step-parent, child, or step-child).
8. Shall be represented by an individual that is 18 years of age or older at the time of submission.

The following rules, terms, and conditions further specify the requirements for entry to the prize.

1. By participating in this competition, each Entrant acknowledges the expectation that funding received as a prize stage winner should support technology development to fulfill the next stage of prize success criteria.
2. Entrants are responsible for complying with all requirements and restrictions of all federal funding received. Federal grantees and recipients of cooperative agreements are eligible to enter the prize, but may not use federal funds from sources outside of this prize to develop their prize submission or to fund efforts in support of their prize submission unless use of such funds is consistent with the purpose and the terms and conditions of their award. Entrants using Federal funds from a grant or cooperative agreement should coordinate with the awarding official at the federal awarding agency.
3. By participating in this prize, each entrant agrees to assume any and all risks and waive claims against the federal government and its related entities, 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 this prize, whether the injury, death, damage, or loss arises through negligence or otherwise.
4. Entrants should maintain appropriate liability insurance for claims resulting from any activity carried out in connection with participation in this prize.
5. By participating in this prize, each entrant agrees to indemnify the federal government against third party claims for damages arising from or related to prize activities.
6. An entrant shall not be deemed ineligible because the entrant used federal facilities or consulted with federal employees during the prize if the facilities and employees are made available to all entrants participating in the prize on an equitable basis.
7. By participating in this prize, each entrant warrants that they are 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 entrant (or is an improved version of an existing work that the entrant 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 entrant is aware.
8. Each entrant must clearly delineate any confidential commercial information contained in a submission that the entrant wishes to protect as proprietary data. Such information will be kept confidential to the extent allowed under applicable federal law. 
9. By participating in this prize, each entrant grants to the BARDA/HHS and Luminary Labs an irrevocable, paid-up, royalty-free nonexclusive worldwide license to reproduce, publish, post, link to, share, and display publicly any non-confidential material submitted to the prize, on the web or elsewhere, such as the submission headline. 
10. Patent Rights for which award funding is accepted under the terms of this prize shall be substantially the same as FAR 52.227-11 (“Patent Rights – Ownership by the Contractor {May 2014}”), https://www.acquisition.gov/far/52.227-11, which is hereby incorporated by reference with the following modifications:  
    1. For purposes of this section, “winner” refers to any entrant that receives prize funding for their participation in this competition.
    2. In the event that the winner elects to file and complete prosecution of such patent applications, the Government shall obtain a nonexclusive, nontransferable, irrevocable, paid up license to practice, or have practiced for or on its behalf, for government purposes, the subject invention throughout the world.
    3. The winner shall notify the prize administrator and the Government in writing of its interest in obtaining such exclusive license rights within thirty (30) days of Subject Invention filing.   
    4. The winner acknowledges that, with respect to any subject invention in which it has retained ownership, the agency has the right to require licensing pursuant to 35 U.S.C. 203 and 210(c), and in accordance with the procedures in 37 CFR 401.6 and any supplemental regulations of HHS in effect on the date of receipt of prize funding.

To participate in the prize, each entrant must warrant that there are no legal obstacles to providing the above-referenced nonexclusive licenses of the entrant’s rights to the federal government and the prize administrator. 

1. Each entrant agrees to follow all applicable federal, state, and local laws, regulations, and policies.
2. Each entrant participating in this prize must comply with all terms and conditions of these rules, and participation in this prize constitutes each such entrant’s full and unconditional agreement to abide by these rules. Winning is contingent upon fulfilling all requirements herein.
3. Each entrant is required to ensure that all releases or transfers of technical data to non-U.S. persons comply with International Traffic in Arms Regulations (ITAR) 22 C.F.R. §§ 120.1 to 130.17.
4. As a condition for winning a cash award in this prize, each entrant that has been selected as a winner must complete and submit all requested winner verification and payment documents to Luminary Labs within 10 business days of formal notification. Failure to return all required verification documents by the date specified in the notification may be a basis for disqualification of a cash prize winning submission.
5. The entrant will not disclose the entrant’s selection as a prize winner until the official winner selection announcement by Luminary Labs and BARDA. If the entrant discloses its selection before the official announcement, the entrant may be disqualified from the Prize and deemed ineligible to receive a prize award.

By participating in the prize, each entrant hereby irrevocably grants to Luminary Labs and BARDA the right to the use of their entity name, city and state, and a short synopsis of their winning submission for promotion of this prize.

Luminary Labs reserves the right in their discretion to disqualify any entrant who is found to be tampering with the entry process or the operation of the prize, the prize website, or other prize-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 prize; or to annoy, abuse, threaten, or harass any other person; and Luminary Labs reserves the right to seek damages and other remedies from any such entrant to the fullest extent permitted by law.

The prize website may contain links to third-party websites that are not owned or controlled by Luminary Labs or BARDA. Luminary Labs and BARDA do not endorse or assume any responsibility for any such third-party sites. If you access a third-party website from the prize website, you do so at your own risk and expressly relieve Luminary Labs and / or BARDA from any and all liability arising from use of any third-party website content.

Submissions will be evaluated using the criteria and process specified in the prize announcement. Luminary Labs reserves the right to amend evaluation criteria at any time. Luminary Labs, technical experts, and/or independent subject matter experts may serve as evaluators or judges, in consultation with BARDA. All judges will comply with conflict-of-interest and ethics requirements. Evaluation and award decisions are at the sole discretion of Luminary Labs and are final and not subject to appeal. Luminary Labs will not make entrants’ evaluation or judging results available to entrants or the public.

Attempts to notify winner(s) will be made using the email address associated with the Team Lead’s submission platform account. BARDA and Luminary Labs are not responsible for email or other communication problems of any kind.

If, despite reasonable efforts, a potential Stage 0, Stage 1, or Stage 2 winner does not respond within ten (10) days of the first notification attempt regarding selection as a 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 winner status and any associated prizes, and an alternate 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.

Notifications to unsuccessful entrants will be made via email. Notifications will be sent out after the notification to the winner(s). No additional details or feedback will be provided to unsuccessful entrants.

Entrants are free to discuss their submissions and their ideas or technologies contained therein with other parties, are encouraged to share ideas and technologies publicly, are encouraged to collaborate or combine with other teams to strengthen their products, 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 prize that conflicts with the prize rules, terms, and conditions may result in disqualification of the entrant’s submission.

Each entrant is encouraged to consult with its legal counsel as to whether publication of a submitted abstract will jeopardize the ability to secure patent protection of any invention submitted. Neither Luminary Labs nor BARDA shall be liable for any loss of IP rights or protection that results from publication of any entrant’s abstract by the Single Shield Prize.

By participating in the prize, each entrant hereby grants an irrevocable and royalty-free license to Luminary Labs and BARDA to store, access, modify, reproduce, and distribute, in-confidence, submissions in perpetuity. All materials submitted as part of a submission become BARDA 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, Luminary Labs reserves the right, at their sole discretion, to disqualify the submission.

Each entrant also warrants that the work is free of security threats and/or malware.

Luminary Labs reserves the right to modify any dates or deadlines set forth in these official rules, terms, and conditions or otherwise governing the prize.

Luminary Labs reserves the right, in its sole and absolute discretion, to determine the number of winners and the amount of each prize award and to allocate, reallocate, or otherwise adjust the distribution of the total prize pool among selected winners. Such discretion includes the ability to vary individual award amounts (including increases), select fewer than the anticipated number of winners, or otherwise distribute available funds based on the quality, eligibility, and merit of submissions. All prize awards are subject to the availability of funds and the final determination by Luminary Labs. This right is in addition to, and does not limit, Luminary Labs’ separate right to modify, suspend, or terminate the competition, or any part thereof, in accordance with the official rules, terms, and conditions.

Luminary Labs reserves the right to cancel, suspend, and/or modify this prize, or any part of it, for any reason, at Luminary Labs’ sole discretion. Luminary Labs reserves the right not to award any prizes if no entries are deemed worthy. Luminary Labs may also discontinue its participation in the prize at its discretion. If Luminary Labs elects to discontinue its participation, every effort will be made to announce that decision promptly on the prize website.

By participating in the prize, each entrant hereby agrees that:

1. The prize administrators shall not be responsible or liable for any losses, damages, or injuries of any kind (including death) resulting from participation in the prize or any prize-related activity, or from an entrant’s acceptance, receipt, possession, use, or misuse of any monetary prize.
2. The entrant will indemnify, defend, and hold harmless the prize administrators 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 entrant’s participation in the prize.
3. Without limiting the generality of the foregoing, the prize administrators 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.
4. These official rules, terms, and conditions cannot be modified except by Luminary Labs 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.
5. This prize is not a procurement or grant action. By submitting an entry, entrants waive any right to protest or challenge, in any forum, the structure, rules, evaluation, selection decisions, or outcome of the competition, including but not limited to any protest rights under 31 U.S.C. § 3551 et seq. or other federal bid protest mechanisms. Luminary Labs retains full and exclusive authority to determine whether any reevaluation is warranted, the scope of any review, and whether any modification to the evaluation outcome is appropriate. All decisions made by Luminary Labs regarding evaluations, reevaluations, and prize awards are final, conclusive, and not subject to further review or appeal.

Entrants are required to identify and address privacy and security issues in their submissions and describe specific solutions for meeting or having met 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, policies, and regulations including the Vaccine and Related Biologic Product Guidance published by the Food and Drug Administration (FDA). 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, it is recommended that entrants apply for approval at or before submission deadlines.

HIPAA  

• Main link: http://www.hhs.gov/ocr/privacy/  
• Summary of the HIPAA Privacy Rule: https://www.hhs.gov/hipaa/for-professionals/privacy/laws-regulations/index.html
• Summary of the HIPAA Security Rule: https://www.hhs.gov/hipaa/for-professionals/security/index.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: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr46/index.html. 
• Institutional Review Boards & Assurances: https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/index.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/science-research/clinical-trials-and-human-subject-protection/regulations-good-clinical-practice-and-clinical-trials.
• Federal Trade Commission Bureau of Consumer Protection — Privacy and Security: https://www.ftc.gov/business-guidance/privacy-security.

Animal Subjects — NIH Applicable only if prize awards are used to support research with animal subjects

• Office of Laboratory Animal Welfare https://olaw.nih.gov/home.html

The failure of Luminary Labs 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. If any provision of these official rules is held invalid or unenforceable, all remaining provisions shall continue in full force and effect.

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 BARDA, 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.

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

Please review the submission platform’s terms and conditions for additional rules that apply to your participation in the prize and more generally your use of the prize website. Such terms and conditions are incorporated by reference into these official rules, terms, and conditions. If there is a conflict between the submission platform’s terms and conditions and these official rules, terms, and conditions, the latter terms shall control with respect to this prize only.

Participation in the prize 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 prize 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 Luminary Labs.

Luminary Labs collects personal information from entrants to the prize. The information collected is subject to the prize website and submission platform’s Privacy Policy.