A: Yes, proposals submitted to this solicitation will be strictly protected consistent with all applicable federal laws and regulations. BARDA complies with all Freedom of Information Act (FOIA) requests but it should be noted that several exemptions would protect the information your question poses including exemptions for trade secrets, confidential financial information, and proposals in general. In the event of a potential future FOIA requests, BARDA would work directly with relevant entities to best ensure proprietary information is safeguarded.

A: There is no preferred format or page limitation, although we request you do not send each CV as a separate stand-alone document. Conveying all relevant information in a concise format is always preferred.

A: The managing entity may consult outside experts, panels, or committees to inform their investment decisions; however, it is expected that the Managing Entity will be held responsible for the investment decision and the performance of the investment portfolio as a whole. Please remember though that the Managing Entity must satisfy the Eligibility Criteria (see Section IV. of the solicitation and other responses to this FAQ) on their own organizational merit and cannot rely on capabilities, experience, etc. of proposed consultants to satisfy the Eligibility Criteria.

A: Key personnel of the Managing Entity are not specifically prohibited but note that the onus is on the Respondent to provide a detailed description of how the Respondent will protect against conflicts of interest. Note also any eventual agreement must contain comprehensive set of policies that would be agreed upon by both parties that address potential conflicts of interest, ethics, and disclosures.

A: There are no requirements on stage of investment, follow-on funding, syndication, or exits. Specifically, we expect the respondents to provide a detailed and independent investment thesis and strategy. In addition, per the solicitation we ask that Respondents provide potential prospective investments that would satisfy the BARDA Ventures partnership for evaluation.

A: Costs associated with indirect rates would be included in the $10 million for the funding scenario described above.

A: Yes, strategic partnerships are allowable and encouraged. However, note that solidified strategic partnerships will be viewed more favorably than potential future partnerships. As outlined in the solicitation, Respondents should provide documented evidence of existing and newly established private investors and corporate partnerships, engagement specific to this opportunity. These strategic partnerships should also include letters of support or commitment, if available.

A: Proposals should be submitted to Drive.Contracting@hhs.gov. IMPORTANT NOTE: There are server email size restrictions in place, which limit the size of the email received to approximately 10MB per email. Submissions must be received on, or before, the submission due time. It is strongly recommended that proposals are submitted with ample time (i.e. preferably 4-6 hours prior to submission deadline) to allow for sufficient delivery and receipt. Emails should be sent separately, as needed, so they do not exceed 10MB per email.

A: Entities should include the most relevant experience for the section as described. Note that BARDA will place a high value on relevant experience if it addresses all of the outlined points in “Section IX. 2. Prospectus of Relevant Experience” of the solicitation. Among other things, this should reflect a clear, successful track record of the prospective Managing Entity demonstrating venture investments and accelerating product development to the marketplace in medical and health sciences.

A: Yes, so long as the legal entity proposing to serve as the Managing Entity directly with the USG satisfies requirements. For example, participation of additional organizations in a cooperative association could be accomplished through “subcontractor” arrangements assuming all other criteria are met. Please remember that the Managing Entity must satisfy the Eligibility Criteria (see Section IV. of the solicitation and other responses to this FAQ) on their own organizational merit and cannot rely on capabilities, experience, etc. of proposed “subcontractors” to satisfy the Eligibility Criteria. Please also remember newly formed entities created specifically for purposes of responding to this solicitation will be considered ineligible for award if proposed as the Managing Entity, however, could be permitted as “subcontractors” to the Managing Entity.

A: Not necessarily. Under Section IV Eligibility Criteria of the solicitation, Eligibility Criterion #2 requires an entity must have “a demonstrated record of being able to create linkages between innovators and investors and leverage such partnerships and resources for the purpose of addressing identified strategic needs of the USG.” It is possible this eligibility criterion could be satisfied without the entity having partnered directly with the U.S. Government. However, please note that there is language under Section IX Evaluation Criteria in the solicitation establishing that “entities with experience partnering with the USG will be rated higher on this aspect of the evaluation criteria than individuals that do not have experience working with the USG. NOTE: This does not preclude entities or individuals without experience partnering with the USG.”

A: The Managing Entity is not necessarily prohibited from subcontracting with for profit entities assuming all other criteria are met. Please note though that the Managing Entity (i.e. an independent nonprofit entity) must satisfy the Eligibility Criteria (see Section IV. of the solicitation) on their own organizational merit and cannot rely on capabilities, experience, etc. of proposed “subcontractors” to satisfy the Eligibility Criteria.

A: SAM registration does not need to be attained by December 8, 2020, but must be attained prior to any award.

A: While there is no specific page limit for responses, BARDA strongly encourages Respondents to present concise proposals in order to convey full understanding of the objectives.

A: An entity must satisfy the eligibility requirements described in the solicitation at the time of submission. For purposes of this solicitation, an “independent nonprofit entity” has been defined as a legal entity that:

(i) is already qualified for tax-exempt status under the Internal Revenue Code and (ii) is controlled by an independent board of directors and maintains accounting independent from any other organization, (iii) is not “fiscally sponsored” or otherwise controlled by any other entity (for profit or non-profit).

Accordingly, an entity in the situation described in the question would not be eligible for consideration as they are not already qualified for tax-exempt status under the Internal Revenue Code at the time of submission.

A: Receiving BARDA funding for a research and development activity unrelated to BARDA Ventures would not necessarily preclude an entity from providing matching funds to a Managing Entity through BARDA Ventures. It is the responsibility of the Respondent to propose a model that contains organizational safeguards to ensure no conflicts of interests exist.

A: The model described would not be ineligible for award on its face. BARDA encourages innovative organizational structures so long as the entity can satisfy and maintain eligibility requirements stated in the solicitation. For example, the entity must be able to maintain its tax-exempt legal status while successfully performing all tasks envisioned under any potential BARDA partnership. Respondents are expected to demonstrate a deep understanding of legal requirements for nonprofit requirements and are encouraged to engage with appropriate experts, as needed, prior to submitting a response to this solicitation.

A: No. As defined in the solicitation, “newly formed entities created specifically for purposes of responding to this solicitation will be considered ineligible for award.” Additionally, for purposes of this solicitation, an “independent nonprofit entity” is defined as a legal entity that (i) is already qualified for tax-exempt status under the Internal Revenue Code and (ii) is controlled by an independent board of directors and maintains accounting independent from any other organization, (iii) is not “fiscally sponsored” or otherwise controlled by any other entity (for profit or non-profit). Therefore, BARDA seeks proposals only from qualified, non-profit entities which are not fiscally sponsored or controlled by another organizations. While subsidiary organizations are not eligible to serve directly as the Managing Entity, this does not prohibit the participation of subsidiary organizations (whether newly created or preexisting) in the proposed operating model of the Managing Entity to achieve the partnership objectives.

A: The solicitation is correct and SAM registration needs to be attained prior to award.

A: In order to preserve the fairness and integrity of the solicitation process we unfortunately will not be able to engage with prospective respondents via individual meetings. Please submit all questions to DRIVe.Contracting@hhs.gov. All questions submitted and accompanying answers may be made public (but would be anonymized and contain no identifying information). When any new announcements or updates to questions and answers are made we will be sure to broadcast all information to the widest audience possible. Interested parties are also encouraged to check the BARDA Ventures website for announcements and updates.

A: Venture Capital is a form of private equity based financing (including equity financing, convertible notes, and/or warrants) that invests in innovative promising technology early in development.

A: While the amount of capital being managed and invested by the VC industry is at an all-time high, there is a noticeable lack of sustained long term investment, from the VC community, in technologies that can prepare the United States and the world for emerging infectious diseases and broader health security threats.

A: BARDA Ventures, extends BARDA’s core principle of public-private partnerships to the investment community, creating, for the first time at HHS, a venture-style partnership that can make quick, agile investment decisions and de-risk transformative technologies so that they can be used for health security needs. We’re preparing to launch this year.

A: BARDA was provided the authority in section 319L of the PHS Act, as amended by the 21st Century Cures Act, 42 USC 247d-7e. “BARDA, may enter into an agreement … with an independent, nonprofit entity to …” achieve the objectives outlined in the solicitation including “the use of strategic venture capital practices and methods.”

A: The Managing Entity will be a nonprofit organization that will carry out the objectives of this partnership by sourcing of technologies or companies, implementing management, investment, development, and commercialization strategies with the ultimate goal of impacting the rapid development of treatments, tools, and technologies to enhance and fortify the United States’ preparedness posture against known and unknown threats, including SARS-CoV-2 and future emerging infectious diseases.

A: For purposes of this solicitation, an “independent nonprofit entity” is defined as a legal entity that (i) is already qualified for tax-exempt status under the Internal Revenue Code and (ii) is controlled by an independent board of directors and maintains accounting independent from any other organization, (iii) is not “fiscally sponsored” or otherwise controlled by any other entity (for profit or non-profit).

Further, the entity must be capable of maintaining this tax-exempt status while successfully performing all tasks envisioned under any potential BARDA partnership). Respondents are required to demonstrate a deep understanding of legal requirements for nonprofit organizations and are encouraged to engage with appropriate experts, as needed, prior to submitting a response to this solicitation.

Prior to an award, an entity must be recognized and certified by the IRS as a tax-exempt organization with a defined mission that is able to meet the objectives of this partnership. Newly formed entities created specifically for purposes of responding to this solicitation will be considered ineligible for award.

A: BARDA anticipates an award with a period of performance of 10 years could consist of an initial award of $10 million made in U.S. Government Fiscal Year 2020, with the intent to provide up to $10 million each subsequent fiscal year for four additional years, based on availability of funding (i.e. resulting in a total of $50 million, if fully funded). A selected Managing Entity should be able to successfully manage increases in BARDA funding amounting to total funding of up to $500 million, as the funding amount provided to the Managing Entity under the Agreement could be modified as necessary up to $500 Million over the period of performance of the Agreement. All funding will be subject to availability of funds.

A: No. The establishment of BARDA Ventures will provide a new tool for BARDA, HHS, and the USG to supplement current medical countermeasure investments. BARDA Ventures will address gaps in pandemic preparedness and areas within the continuum of response for health security threats which require innovative and entrepreneurial approaches that would not otherwise be considered under traditional medical countermeasure advanced research and development.

A: The investments made by the managing entity must fall within the BARDA mission of health security and pandemic preparedness. A Joint Oversight Committee comprised of USG personnel and the Managing Entity and will collectively set the priority for investments in high level terms, and will agree upon technology areas to pursue that are within the BARDA mission space.

A: While BARDA Ventures concept was originally conceived before COVID-19, it will be positioned to make investments in enabling technologies that have an immediate impact in responding to the current pandemic as well as preparing for future pandemics.

A: The primary goal of BARDA Ventures is to develop successful technologies that increase the US ability to prepare for and quickly respond to health security threats. Secondary goals include increasing the impact of taxpayer investment into the health security ecosystem, and proving investment in health security can generate financial returns for private investors.

A: BARDA Ventures will be operated out of BARDA’s the Division of Research, Innovation, and Ventures (DRIVe). DRIVe is the innovation hub for BARDA and coordinates across BARDA programs to share ideas and information as necessary or allowed to support and improve innovation across the whole organization.

A: BARDA has been committed to gathering the necessary market research to successfully execute this partnership and has engaged with potentially interested partners and solicited feedback on development of this partnership from venture capital entities, US government agencies, and other stakeholders. BARDA issued two RFIs, in January and October of 2019, and met with over 60 stakeholders throughout the market research process.

A: BARDA has engaged industry and other government agencies through extensive market research put BARDA ventures in the best place for success. BARDA is confident this solicitation will allow us to find and select a well-qualified partner to successfully carry out this partnership. The oversight and guidance provided by BARDA throughout the partnership will maximize the impact on the BARDA mission and larger health security ecosystem.

A: One of the benefits of using venture capital practices is the ability to crowd in private capital to amplify the impact of tax payer dollars. A goal of the ManagingEntity will be to raise additional capital that matched the funding provided by BARDA, these private or corporate investors would the vision and goals of BARDA and their money would be invested alongside funds in every deal. The private investors would not have say over the investment decisions made by the Managing Entity. The managing entity will put in place a detailed conflict of interest plan to avoid organizational or personal conflict of interest within the Managing Entity or with any private investors.

A: Success for the BARDA Ventures partnership means success for the health security mission overall. If a portfolio company succeeds in generating positive gains by bringing a new product to market, goes public, or is acquired by/sold to another company, proceeds from investments made with taxpayer funds will be recycled back to the Managing Entity for additional investments. Thus multiplying and sustaining the impact to the nation by continuously seeking to address emerging threats.

A: No.

A: This solicitation is for BARDA to find a nonprofit partner with venture capital experience to be the Managing Entity for BARDA Ventures. Once the partnership is established the Managing Entity will be responsible for sourcing, evaluating and investing in promising technologies, through coordination with a joint oversight committee. Companies interested in funding for technology development should wait until the Managing Entity is selected or explore other methods of partnering with BARDA via other open BARDA funding opportunities.

A: After a Managing Entity is selected, BARDA will announce how best to engage with the Managing Entity to seek an investment.