Attachment 2_FAQ for BAN 2.0 Solicitation_Rev. 2 (1.2.24).pdf

BAN 2.0 Solicitation Page 1 of 14 Attachment 2 – FAQ_Revision 2

FAQ for BAN 2.0 Solicitation – Revision 2

Revisions are notated with a corresponding bar in the right column.

BAN-BARDA Accelerator Network

DEV-Development, Evaluation, and Validation

Eligibility and Requirements

1) Do current or prior contracts with BARDA preclude BARDA Accelerator Network (BAN)

2.0 eligibility?

No, only current or former BARDA personnel (federal employees, fellows, or support contractors) who worked for BARDA on the Accelerator Network within the previous year or at the time of the proposal submission, are ineligible to respond.

2) For the proposal, are there preferred font sizes or a page limit?

There are no restrictions for font sizes or a page limit. However, BARDA encourages conciseness and anticipates that applicants can thoroughly address all components of the application in fewer than ~100 pages. Original ideas and approaches are encouraged, so the proposal structure is up to the applicant. The only exception is the cost/price workbook, for which there is a template.

3) What type of accounting information should be included in the proposal?

The type of accounting system, its design and operation features i.e., indirect burden calculations and allocation functions, ability to separate project costs, etc., should be included in sufficient detail for BARDA to be able to evaluate its adequacy to meet the financial terms of the contract.

4) Can an entity/consortium apply to multiple technology areas?

An entity/consortium can apply to more than one technology area. However, an entity can only be the prime awardee for a single Hub. Entities should keep this in mind when applying to be a part of multiple Hubs being awarded at the same time. A single entity can be a subcontractor on multiple proposals.

5) Does the prime awardee need to have expertise in all the required components of BAN

2.0?

The prime awardee needs to demonstrate the ability to manage the operations of the Hub and to receive and disburse funding. The Hub (single entity or consortium) needs to have the expertise and capability to deliver all three components of BAN 2.0: Wraparound Services, DEV Services, and Rapid Response Capability.

6) Does the prime awardee need to have a physical location?

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The prime awardee does not necessarily need to have a physical location if it can successfully perform its role in a remote capacity.

7) Should the Hub be geographically diverse?

The geographical diversity of the Hub partners should be as expansive as necessary to perform the functions of the Hub and to support innovators and companies around the globe.

8) What are the important components of a proposal?

A competitive proposal will provide detailed descriptions of how the collective Hub plans to

(1) source and support early-stage health security technologies and companies (Wraparound Support), (2) facilitate and fund development, evaluation, and validation projects (DEV Services), and (3) build an infrastructure for rapid development and deployment of health security products (Rapid Response Capability). A competitive proposal will demonstrate that the Hub partners have the requisite combined experience to perform all capabilities. Prior experience need not be specifically in the area of health security as long as there are demonstrated capabilities in life science technology development and commercialization support.

9) Do applicants have to apply as a partnership?

It is not required; however, we anticipate that in most cases partnerships will be necessary to ensure all of the capabilities of the Hub--Wraparound Support, DEV Services, and Rapid Response Capability.

10) Are non-US entities eligible to participate in BAN 2.0?

Non-US entities are eligible to apply; however, preference will be given to US entities, especially at the prime award level.

11) How can institutions of higher education be part of a Hub network?

Institutions of higher education can help source early-stage technologies and companies for the Hubs. They can also be providers of DEV services or potentially offer wraparound support.

12) Please describe the function of the Teaming page.

The Teaming Page/Partner List is a forum for entities to describe their capabilities and look for other entities with complementary capabilities. BARDA merely posts this information. It is up the entities to contact each other or not. By enabling and publishing the Teaming Partner List, BARDA is not endorsing, sponsoring, or otherwise evaluating the qualifications of the individuals and organizations that are self-identifying for placement on this Teaming Partner List.

13) Will all submissions to the Teaming Page be posted?

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BARDA reserves the right to edit or decline to post any information submitted by an organization if BARDA determines that the information submitted is not within the scope of the questionnaire and/or within the scope of the BARDA Accelerator Network 2.0 program, is determined to be an otherwise irrelevant submission, is deemed unfit for public consumption, or for any reason at BARDA's discretion.

14) How do I submit my company’s info to be placed on the Teaming Page?

For instructions on submitting to the teaming page, visit:

https://drive.hhs.gov/acceleratorrfi.html

15) How often is BARDA updating the Teaming Page?

We are currently updating the Teaming Page every 1-2 weeks though the frequency of those updates may fluctuate based on volume and timing of submissions.

16) Can a company that facilitates or provides DEV services be the prime awardee?

The prime awardee can be the facilitator or provider of DEV services. The prime awardee is required to manage the operations of the Hub and receive and disburse funding.

17) What kinds of entities are eligible to be providers of DEV services?

Any entities capable of providing DEV services are eligible.

18) Does having the support of government agencies strengthen your application?

Current or prior partnerships with BARDA or other federal agencies are only relevant to the evaluation process if they demonstrate requisite experience or capabilities. It is also acceptable to demonstrate these elements through private partnerships.

19) What specific capabilities is BARDA looking for from the Hub during a rapid response scenario?

During a rapid response scenario, BARDA would leverage the hubs for rapid sourcing, selection, and funding for product development as well as to provide ramped-up wraparound services. Timelines for sourcing and distributing awards for product development need to be condensed from weeks to days. It is up to the Hub to decide how to maintain its rapid response network. Some of the partnerships might be active on an ongoing basis and some might be in reserve for when they are needed during a critical event. As part of the proposal, we ask applicants to describe how they would use $100M in emergency funding to rapidly scale-up wraparound accelerator services and the sourcing, reviewing, and awarding process for DEV projects.

20) Is this RFP only looking for contract management firms?

https://drive.hhs.gov/acceleratorrfi.html

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No, this requirement is open to all eligible entities. Contract management firms are not being sought out and may not have the desired capabilities.

21) As a potential future cohort member or start-up candidate seeking to obtain accelerator services directly with the Accelerator Hub, can/do we begin establishing those relationships now or later?

The Hubs have not been established yet. However, once the awards under the BAN 2.0 solicitation are announced, you may connect with the Accelerator Hub directly. We encourage you to check back and visit the DRIVe BARDA Accelerator Network webpage for updates.

22) Does the solicitation have any requirements or restrictions against 501c C6 or C3 organizations to be a prime awardee?

Non-profit organizations are eligible to respond, as are all organization types.

23) In the context of Special Populations, how is low resource setting defined?

As broadly defined, the term low-resource settings generally refers to settings in which there is limited capital and human resources which creates barriers such as limited access to overall health care.

24) The guidance for Special Populations lists three very distinct populations, and yet my understanding is only one will be funded. Is the expectation to focus on one of those sub-groups, or multiple?

At this time, BARDA anticipates only one Hub will be funded within the Special Populations technology area. Respondents may propose either pediatrics, immunocompromised, low resource settings, or a combination of any three of these subgroups.

25) One Hub is focused on Special Populations while all the others are focused on the type of company (Medical Device, Diagnostic, Therapeutic, Digital Health). Can you clarify what you are looking for relative to these Special Populations given all the “companies” pulled in to work with will represent one of these categories?

We are looking for the Special Populations Hub to focus on one or more of the three subcategories (pediatrics, immunocompromised, low resource settings) with the expectation that the technology types could span across any of the technology areas including diagnostics and medical devices, therapeutics and vaccines, digital health, etc. For example, if the Special Populations Hub is pediatrics focused, the start-up companies being supported by the Hub could potentially support the medical devices technology area as well as any number of other technology areas. BARDA understands that there is potential for overlap however BARDA will be working closely with each individual Hub and across all the Hubs in the network, particularly when funding projects under the DEV services to ensure that the individual projects are not duplicative in nature.

26) Can technologies target markets outside of the US? Do technologies have to target US

BAN 2.0 Solicitation Page 5 of 14 targets?

There is no limitation or requirement on what the target market is or where the technology is coming from. With the initial five Accelerator Hubs that will be established under this program, BARDA is looking for companies that can source technologies effectively across both the US as well as globally that fit the particular area of interest.

27) Can you clarify on the specific difference between the current BARDA Accelerator Network with the 13 institutions and this next BARDA Accelerator Network 2.0 program.

Do the original 13 continue to operate accelerators or is this a replacement to the services they have been providing?

The BARDA Accelerator Network 2.0 is an entirely new program. There are currently 4 partners that have active cooperative agreements under the current BARDA Accelerator Network. There are no restrictions or limitations on who can submit a proposal to the BARDA Accelerator Network 2.0 solicitation, including previous or current BARDA Accelerator Network partners.

28) How can a small entity know about the consortia that are being built and ask to join?

The teaming page was created to facilitate connections by providing a platform whereby companies can self-identify their company information within the parameters of the teaming questionnaire. This allows all interested parties to review those companies that have provided their information as potential teaming partners and then decide whether to leverage the information at their own discretion and as they see fit. BARDA will not directly make those connections or recommendations. To re-iterate, by enabling and publishing the Teaming Partner List, BARDA is not endorsing, sponsoring, or otherwise evaluating the qualifications of the individuals and organizations that are self-identifying for placement on this Teaming Partner List.

29) Will BARDA show preference for Hubs that accelerate health security companies specifically, or does a Hub just need to accelerate any company within its focus area (e.g.

does a therapeutics Hub need to accelerate therapeutics companies with explicit health security goals, or accelerate any therapeutics companies?

We understand that not every technology area start-up will have a direct health security use case. That said, the Hubs could support companies that may have technologies that have a use case that is within BARDA’s mission space as their first, second or even third use case. The main goal is for the Hubs to support these companies to reach market faster and then those companies to be able to pivot and grow their use cases to help support BARDA’s areas of interest.

30) Do you require a Hub to partner with an established company that has the infrastructure for rapid response, or will you consider funding a new infrastructure for rapid response?

There may be organizations that already have the infrastructure in place that can support large-scale rapid response efforts. However, there are organizations that do not have that

BAN 2.0 Solicitation Page 6 of 14 infrastructure in place. What we are looking for from proposals is to understand what a Respondent would do in the event of a rapid response scenario and how it would scale its processes through the proposed approach which can include support from its network of organizations, partnerships, etc.

31) Will collaborating with 1-2 BARDA-funded accelerator partners be reviewed favorably?

No. As this is a new program, BARDA will be evaluating the proposals independently from the current Accelerator Network. Current or prior partnerships with BARDA are only relevant to the evaluation process if they demonstrate requisite experience or capabilities.

32) Are Co-Principal Investigators allowed for this proposal?

There is no requirement on the number of personnel or specific labor categories that the Respondent must propose.

33) Could you provide more details about what constitutes experience building a network of innovators, startups, investors, strategic partners, experts, mentors, and other innovation ecosystem partners'?

From the solicitation, an example of the relevant experience would be establishing and maintaining a network of R&D capabilities and technical and commercialization support that is suitable for accelerating health security innovations to market.

34) What are the key success metrics for the Hubs?

Specific metrics will be established through the negotiation process based on the specifics of a successful proposal.

Accelerator Programming and DEV Services

35) What technology readiness level (TRL) level(s) should the Hubs support in terms of accelerator programming and DEV services?

We recognize the innovative value of companies at all TRL levels from ideation, development, and growth. The Hub is entrusted with sourcing technologies/companies at various stages, supporting them with relevant accelerator programming, and identifying DEV projects that accelerate innovations on the pathway to market launch. Additional factors such as the type of technology and market maturation may play a role in the types of technologies a Hub supports.

36) How will the Hubs stay up to date on BARDA’s priorities so that the most relevant startups/DEV projects can be sourced/identified?

During monthly meetings with each Hub, the BARDA program team will provide any updates to priorities within the Hub’s specific technology area. Additionally, we will collaborate with the Hub on a year-by-year basis to identify and establish the technical focus of the Hub for the following year to ensure the Hub are accelerating technologies that are relevant to supporting the mission of

BAN 2.0 Solicitation Page 7 of 14 the program and BARDA.

37) What is the difference between the Accelerator Network and CARB-X?

CARB-X is a global non-profit partnership accelerating antibacterial products to address drug-resistant bacteria, a leading cause of death around the world, funded by BARDA and multiple global, federal agencies and non-profit organizations. The BARDA Accelerator Network is solely funded by BARDA to provide product development, commercialization, and business support to a wider range of early-stage technologies within the five Hubs (Diagnostic/Medical Devices, Therapeutics/Vaccines, Enabling Technologies, Digital Health Tools, and Special Populations).

38) How many DEV projects should be funded per year with base funding?

The goal of DEV services is to fund a targeted development, evaluation, or validation project that markedly advances the technology towards product launch. Since innovators and startups have unique needs in this area, the number will vary based on the type of technology, scale of the project, TRL level, etc. BARDA anticipates typical funded projects to be in the range of $50k–$200k each, depending on the scope of individual projects.

39) How do you envision this program scaling over the next 5 years?

We intend to maintain the base funding of the program at $1.5M over the duration of the 10-year OTA. During normal operations, on a year-by-year basis, we will evaluate the strength and impact of the program and elect to scale services as needed, based on the availability of funds. In the event of a public health emergency or an event that BARDA considers to be a rapid response scenario, BARDA could coordinate with the Hubs to scale their operations and outputs within the limits of each contract ceiling of $500M.

40) What kind of external support do you envision will need to be sought out to support the companies in the accelerator?

Within the Wraparound Accelerator Services function of the Hub, we want to ensure startups have access to a network of mentors, industry experts, and key opinion leaders with technical and business expertise that includes, but is not limited to, scientific/technical, manufacturing, quality assurance, nonclinical, clinical, business development, regulatory, reimbursement, intellectual property, legal, marketing, fundraising/financing, and strategic partnerships. Additionally, within the Development, Evaluation, and Validation Services function, we want to ensure that startups receive both commercial and technical mentorship when developing their projects.

We see this network of supporters to be both internal to the Hub and external (mentors, consultants, ecosystem partners, etc.).

41) Do startups lose any equity or rights when they join the Accelerator Network program?

The startup will never lose any equity or rights as part of the Accelerator program. The goal of the program is to support the technical and commercialization goals of the startup to support them to develop their product and bring it to market faster. The Accelerator Hubs are prohibited from using HHS funds obligated to an Agreement under this solicitation to conduct investment activities including, but not limited to, taking equity positions in any entity supported under the BAN 2.0 program. It is important to note that this does not prohibit the Accelerator Hub from

BAN 2.0 Solicitation Page 8 of 14 taking equity positions in any of the supported entities but rather limits the use of HHS funds for these activities.

42) Do development services include providing engineering design services and design for manufacturing services to accelerator companies?

Yes, it can if that is the next developmental need for the startup.

43) How does BARDA envision funding decisions to be made for DEV Services awards during normal operations in each year of funding?

Solicitations issued by an Accelerator Hub could result in sub-awards structured like grants, contracts, prizes, challenges, competitions, or other mechanisms as allowable under BARDA authorities. Each Accelerator Hub will be expected to run at least one funding solicitation each year and support multiple projects with the potential to support additional projects based on BARDA’s needs and the availability of additional funding.

44) How does BARDA envision funding decisions to be made for DEV Services awards during a rapid response scenario?

During a rapid response scenario, should BARDA choose to exercise the option of allocating significant additional funds (up to the OTA agreement ceiling of $500M) to the Accelerator Hub, the Hub will need to be able to boost its capability to identify partners, deploy funds, and provide wraparound support for the requested rapid and scaled-up services (both with internal capabilities and relevant external partnerships). The Accelerator Hubs will be required to effectively source, review, distribute, manage, and support multiple concurrent awards (potentially in the 100s) to meet aggressive USG timelines.

45) How much flexibility will the Hub have to adjust DEV Services awards after they have been approved?

For the DEV services, we are seeking partners that can develop, run, and manage funding solicitation topics to address the needs within their Technology Hub area. The Accelerator Hubs are responsible for coordinating with BARDA for milestone-based updates on individual projects.

Not all projects will always be successful. As such, the Hubs can terminate projects that fail to meet milestones and reallocate resources accordingly with input from BARDA.

46) How does BARDA anticipate that companies will apply to the Hubs for funding once the network is established?

The specific process for companies to apply to a particular Hub’s program for support will be determined on a case-by-case basis during the negotiation phase and upon award to the Hub.

47) Approximately how many companies will need the DEV services and Rapid Response?

For DEV services, there is a limited amount of base funding that will be negotiated to go towards individual DEV projects. Thus, there is a limited number of companies that can be supported for

BAN 2.0 Solicitation Page 9 of 14 the DEV services by the Accelerator Hub. However, during a Rapid Response scenario such as a public health emergency, there may be significantly more funding that could potentially support a larger volume of companies.

48) Could you please provide some practical examples of different Accelerator Hubs collaborating in the future?

Within each of the five technology areas, BARDA understands that there will be overlap for companies that can support Enabling Technologies while also having the capabilities to support both Diagnostic and Medical Devices as well as Therapeutics and Vaccines. Similarly, we understand that there is overlap where a company proposing to support Special Populations may also be able to support multiple technology areas. That said, there will be opportunities for Accelerator Hubs to collaborate to ensure that all the companies get the support they need based on the expertise of the respective Accelerator Hub.

49) What is the process for DEV services in terms of how the solicitation for those individual projects will be executed under each Accelerator Hub program?

Each year, BARDA will establish the priority and focus areas and then come up with the solicitation process together with the Hub. The Hubs will then be expected to run the sourcing, review, selection, etc., in accordance with the established process. The solicitation released by the individual Hubs will not be posted on SAM.gov; they will be publicized in accordance with the process established by BARDA and the Hub.

50) While the awarded Hubs will focus on various Technology Focus Areas, how will the "projects" that are stood up in execution of the Hubs be defined. For example, will the Hub set up topics under the Technology Focus that will become Projects or will BARDA have "Calls" for specific technology that they want a project built around, or is it a combination of both?

BARDA will frequently update each Hub on mission priorities relevant to each technology area to facilitate the sourcing of aligned projects.

51) With regards to the $1 million per year allocated for DEV services, will 100% of the funds be paid directly to startups?

The $1 million per year of DEV funding is intended to cover DEV funding to startups as well as operational costs for the Hubs related to those DEV services. Most of the funds should go directly to the startups, but BARDA recognizes that that the Hubs will have operational costs associated with managing DEV project phases including initial sourcing, design support, and ongoing mentorship. In some cases, DEV funds could be paid to a third party to perform a study on behalf of a startup requesting funding. Sample budget justifications will be reviewed as part of each DEV project proposal.

52) May the Accelerator Hub prime awardee provide services to innovators and companies interacting with the Hub that go beyond Wraparound Accelerator Services, DEV Services, and Rapid Response Capability Services? For example, may the Hub provide unique

BAN 2.0 Solicitation Page 10 of 14 experimental and/or scientific computational services that advance the particular project that an innovator/company is pursuing with BARDA support via BAN 2.0?

Respondents may provide services that go beyond wraparound Accelerator Services, DEV Services, and Rapid Response Capability Services to the extent they would enhance the services as outlined in the solicitation.

53) Are we required to invest in or find investment in startup technologies? If so, is there a suggested investment level, i.e. seed, etc.?

The Respondent is not required to invest in startups directly and is restricted from taking equity positions in any startup or company supported under the BAN 2.0 Program using HHS funds. A component of the DEV services is the requirement to design and launch solicitations to support the technical development of projects that are agreed upon by both the Hub and BARDA. The solicitations issued could result in sub-awards structured similarly to grants, contracts, prizes, challenges, or competitions. The funded projects must be designed with established milestones and funded projects should be provided with both technical, wraparound, commercialization support, and access to experts and mentors.

54) "The Accelerator Hubs are required to launch these projects within 2 months or less from the receipt of project applications.” What is the definition of launch? What is the definition of project application, does that mean to the Accelerator Hub?

Once the Hub designs a solicitation, it must actively source, review, and award DEV projects (with BARDA approval). The term “launch” in this case refers to the period when the Hub receives applications to the time the projects are funded and actively ongoing based on the established project milestones.

55) Under special populations you list ‘resource-limited settings’. Does this apply to domestic resource-limited settings or low and middle income countries (LMIC) as well?

For the BAN 2.0 program, BARDA is interested in both settings as we aim to make this a global program. For the proposals, we are open to organizations proposing on the types of specialized services/mentorship/support they can provide startups to succeed in these ecosystems based on their expertise and how they would develop the program to accelerate the development of technologies to address common hurdles/needs/intricacies that come with developing countermeasures to be accessible to LMICs.

Funding/Contracting

56) Will proposals be reviewed and evaluated by BARDA as they are submitted?

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No, BARDA will begin the formal review process of all proposals at the same time following the submission due date.

57) What is the process for adding funds for additional DEV projects?

Subject to BARDA funds availability and BARDA’s prioritization of mission requirements and needs, BARDA will obligate additional funds for additional DEV services. The process for negotiation, approval, and obligation is subject to negotiations with the apparent successful Respondent.

58) What is the timeframe from submission to award?

BARDA intends to award each agreement withing 90-120 days following the submission due date of each respective technology area. However, BARDA may award before the 90 days or after the 120 days subject to negotiations and at BARDA’s discretion.

59) How is cost sharing evaluated in an application?

Cost sharing / resource contributions are strongly encouraged as additional allocated funds further augment services to startups and foster market readiness of their technologies.

60) Is an active System for Award Management (SAM.gov) account required to be eligible for award?

Respondents must be registered in SAM.gov to be eligible for award. Respondents do not need to have an active registration at the time of proposal submission. However, BARDA highly encourages initiating registration as early as possible to avoid any delays during the negotiation or award process. When submitting your application, please select to be eligible for “all awards”, and not “federal assistance awards”. The latter is a “grants only” path which will not make you eligible to receive an award under the intended OT agreement from this solicitation.

61) How can we obtain a copy of the Proposers’ Day slides and recording of the webinar?

The BAN 2.0 Proposers’ Day slides are available on SAM.gov under the published BAN 2.0 solicitation. BARDA will not be publishing a recording of the webinar session.

62) Is there a place where you can find specific projects / companies / partnerships that BARDA is currently funding?

You may find a list of BARDA's announcements which include many of our recent awards/partnerships: https://medicalcountermeasures.gov/newsroom/

You may also find projects specifically executed by BARDA DRIVe:

https://drive.hhs.gov/map/index.html

63) Do we need to propose cost share?

https://medicalcountermeasures.gov/newsroom/ https://drive.hhs.gov/map/index.html

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Though cash or in-kind contributions are encouraged and greater contributions will be considered favorably, it is not required.

64) Is it a possibility that if there isn’t a public health emergency within the next five to ten years, that the $500M ceiling could be used for other BARDA priorities by the future Hubs?

Yes, the intent is to establish a program that can support all of BARDA's mission, which includes development work not directly related to a public health emergency and that could involve any number of events or requirements that could be categorized as a rapid response scenario.

65) Do the operational costs for executing the $10M in awards need to come out of the $1M DEV funds or will that be funded separately?

Subject to BARDA funds availability and mission prioritization, if BARDA obligates an additional $10M in funds, this amount would include an amount allocated to Hub operational and program management expenses which would be subject to negotiation.

66) Can service provider's discounted service be considered as cost share?

Potentially, yes.

67) How does the Accelerator Network interface with BARDA’s RRPV and BioMaP initiatives?

All of the BARDA portfolio is awarded strategically so as to complement one another. Specific interplay would be determined if and when all three programs are launched.

68) Is there a possibility that BARDA may extend the 9-15-2023 deadline for Diagnostics/Medical Devices hub application?

We are not anticipating extending any deadlines at this time but reserve the right to do so.

69) Will the awards that flow down through awarded Hubs be restricted to those companies that were named as partners or will there be opportunity for Hubs to add companies that bring innovation to them during execution but were not named in an original proposal?

There will be opportunity for the Hub to remain fluid and evolve with new opportunities within the scope of the relevant technology Hub.

70) Can you elaborate on resource/cost-share contributions and what you are ideally looking for? Donations, reduced fees?

Some examples of resource/cost-share contributions can include the Respondent offering to contribute to paying for expenses such as those associated with direct labor, travel, material, and equipment, or even subcontractor costs however, this is not an exhaustive list and can be proposed in any number of ways. We are receptive to a variety of different types of cost-share including cash or in-kind contributions that provide real value.

71) Will the Respondent receive periodic status of a submitted proposal?

Unfortunately, due to the volume of submissions we expect, we do not anticipate being able to provide ongoing updates to all Respondents on the status of their proposal. However, the decisions

BAN 2.0 Solicitation Page 13 of 14 will become publicly available information once the awards are finalized and all companies have been notified.

72) Can you expand and clarify on the cost sharing requirements of the vehicle? Is that at a prime level or does it flow down to each award made by the Hub?

There is no requirement for resource/cost contribution. However, as stated in the solicitation, greater cost/resource contributions will be considered favorably. The cost/resource contribution will be reviewed initially in the cost/price proposal at the prime level. The individual projects that are funded by the Hubs may also include a resource/cost contribution element.

73) Are non-traditional contractors exempt from resource/cost contribution requirements?

There is no requirement for resource/cost contribution including those Respondents deemed to be non-traditional contractors. However, as stated in the solicitation, greater cost/resource contributions will be considered favorably.

74) Please advise if there will be any collaboration or relationship between BARDA Technology Hubs and ARPA-H.

Although BARDA works across Government through various programs, this is a BARDA-specific program that focuses on BARDA specific mission areas and will not be collaborating with ARPA- H for the BAN 2.0 program.

75) When does BARDA expect the Hubs to be operational and enlist and fund MCM companies?

BARDA will try to fund and award the first three technology area Hubs by the end of calendar year 2023 and the final two Hubs in the spring of 2024; however, the timeline will vary and awards will be made 90-120 days after the submission due date for each technology area.

76) By the last technology area deadline of January 12, will we know who was selected from the earlier technology areas?

We intend to award each OT agreement within 90-120 days from each submission due date, however that timeline may change at BARDA’s discretion. If we award within the lower range of about 90 days, there is a possibility that we will have awarded the first three technology area Hubs by the January 12, 2024 deadline for Digital Health Tools and Special Populations. We encourage you to check back and visit the DRIVe BARDA Accelerator Network webpage for updates.

77) In the solicitation there is a reference to Rapid Response Capability Activation Plan (Appendix I), but this is not included in an appendix. Is this still a requirement?

The Rapid Response Capability Activation Plan is not required at this time.

78) Are multiple levels of subcontractors allowed in structuring the proposal?

Partnerships/Teaming/Subcontractors are allowed and encouraged as part of a Respondent’s proposal. BARDA anticipates that at least some of the Respondents will require collaboration with

BAN 2.0 Solicitation Page 14 of 14 subcontractors to provide requisite support for ancillary services as well as the core wraparound, DEV, and Rapid Response services.

79) Do you have any guidelines for the section referring to organizational conflict of interest (OCI) (under IV. Other requirements)? Should we fill out a spreadsheet or is there a specific form?

There is no form or template. You may submit the required information in a format of your choice as long as it addresses all the information as required in section IV.

The requirement to disclose OCI is relevant to any individual member of the prime, subcontractors, consultants, etc that is being proposed to perform services and as described in detail in section IV.

80) Does BARDA have a written policy regarding the inclusion or limitation of General and Administrative costs that would be applicable to the BAN 2.0 solicitation? If none exists, do you rely on the HHS Grants Policy Statement and 2 CFR 200?

If proposed, an organization’s proposed G&A indirect rate/costs as an element of the overall proposed price/cost, will be evaluated for completeness and value to the Government. The evaluation of proposals received under the BARDA Accelerator Network 2.0 solicitation does not rely on 2 CFR 200 as the anticipated awards are pursuant to BARDA’s other transaction authority.

81) The Price Cost workbook asks to identify personnel by “Labor Categories”. We want to make sure we are using the correct labor categories. Where can we find the official categories BARDA uses?

The solicitation does not prescribe “required” labor categories. Respondents should propose labor categories that are commensurate with the proposed approach to meet the requirements of the solicitation.

82) The Price Cost Workbook include a field for a Material Handling rate (M/H). We do not have a M/H rate. Is this required?

A material handling rate, G&A, overhead, fringe, are not required. You may leave any indirect rates that are not applicable blank.

83) Will you be providing feedback to Respondents whose proposals were not selected for award?

All Respondents will be notified via email with a disposition of their proposal, however debriefings including feedback, ratings, etc. will not be offered.