BARDA Accelerator Network 2.

0: Request For Information (“RFI”)

Posting Date: June 8, 2023

Amendment 001: June 21, 2023 – Revise Due Date to July 7, 2023
Amendment 002: July 7, 2023 – Revise Teaming Questionnaire and Instructions, Revise
Due Date to July 21, 2023
Amendment 003: July 13, 2023 – Revise Due Date to July 18, 2023

Biomedical Advanced Research and Development Authority

Administration for Strategic Preparedness and Response
U.S. Department of Health and Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20201

To: Prospective Partners & Interested Parties

Subject: RFI Overview & Response Instructions

The Division of Research, Innovation and Ventures (DRIVe) of the Biomedical Advanced
Research and Development Authority (BARDA), the Administration for Strategic
Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services
(HHS) is issuing this Request for Information (“RFI”) in order to collect feedback on the
attached draft solicitation document (see “Attachment 1: BARDA Accelerator Network 2.0
RFI: Draft Solicitation For Comment”) and obtain information for potential teaming
opportunities.

Information collected from this RFI will serve as continued market research for the
refinement of the next iteration of the BARDA Accelerator Network (BAN 2.0) requirement
using BARDA’s Other Transaction Authority to foster the health security innovation
ecosystem with commercialization and wrap-around support and to enable rapid
development, evaluation, validation, and commercialization of medical countermeasures.
BARDA envisions that BAN 2.0 will support BARDA’s mission by addressing the following
objectives/tasks:
• Support health security innovators, startups, and existing BARDA partners
(“portfolio companies”) by providing wrap-around accelerator services including
entrepreneurship education and access to technical and
business/commercialization expertise and resources.
• Provide BARDA with product development capabilities to source, review, fund,
accelerate, and perform evaluation and validation of medical countermeasures
based on BARDA’s strategic priority.
• Build a rapid emergency response mechanism to fund and accelerate product
development and validation of MCMs that can be developed and deployed as quickly
as possible in the event of a public health emergency.
 BARDA Accelerator Network 2.0: Request For Information (“RFI”)

Further background information is described in the attached draft solicitation.

BARDA is seeking the following:

(1) Information and feedback on all components of the attached draft solicitation with
comments and feedback sought on the pertinence and feasibility of each component
of the draft document. This includes, but is not limited to, feedback in the form of
questions/comments related to: restrictions; authorities; proposal instructions;
evaluation criteria; hypothetical pricing information/ceilings, and overall
solicitation structure as detailed in the draft document. Interested parties are
encouraged to provide feedback in the attached Excel spreadsheet (“Attachment 2 -
RFI_Draft Solicitation Feedback Form”) referencing the page and line numbers,
including edits/comments.
(2) In anticipation of the future final published solicitation (which could potentially
come as soon as late July, 2023), BARDA intends to develop a Teaming Partner List
to support and facilitate connections between interested parties for one or more of
the listed capabilities requested for BAN 2.0 (Wrap-Around Accelerator Support
Services; Development, Evaluation, and Validation Services, and Rapid Response
Capabilities). By enabling and publishing the Teaming Partner List, BARDA is not
endorsing, sponsoring, or otherwise evaluating the qualifications of the individuals
and organizations that choose to self-identify themselves for placement on the
Teaming Partner List. The Respondent should submit the Partner Teaming Form
(“Attachment 3 – BAN2.0 Teaming Questionnaire”) in their response to
BAN_inquiries@hhs.gov. Respondents may download the Partner Teaming form
which is attached to the notice on SAM.gov or via DRIVe’s website at
https://drive.hhs.gov/acceleratorrfi.html. By providing such information, you
consent to this information being posted publicly so that all interested parties can
freely engage. The teaming form submissions will be posted on DRIVe’s website at
https://drive.hhs.gov/acceleratorPartnerList.html BARDA will update this webpage
periodically at BARDA’s discretion based on the frequency and volume of
submissions. 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 scope of the questionnaire and/or within the scope of the BAN 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.

Important Note: Interested parties should not prepare or submit an actual proposal
to the attached draft solicitation document in Attachment 1. The purpose of this RFI
is only to collect information by receiving feedback/comments to the draft
solicitation. Accordingly, BARDA will not issue any awards from responses to this RFI.
Responses will not be evaluated in any way, but may be used to further develop and refine
the described requirement. BARDA will not return or provide feedback on any submissions,
but BARDA does reserve the right to further engage with respondents to clarify their
understanding of submitted comments. Additionally, while we will not provide feedback to
this RFI, commonly asked questions and accompanying BARDA responses may be made
public and would be anonymized to contain no identifying information.
 BARDA Accelerator Network 2.0: Request For Information (“RFI”)

BARDA will treat any response to this RFI as source selection sensitive information and will
protect confidentiality accordingly. By submitting a response to this RFI, you understand
and acknowledge that review of those responses may include non-federal BARDA
personnel serving in scientific, engineering, and technical assistance (“SETA”) or similar
support service roles.
Documents are to be submitted electronically via email to BAN_inquiries@hhs.gov by July
18, 2023, 09:00 AM ET. Questions should be sent directly to BAN_inquiries@hhs.gov.

Thank you in advance for any submission as we anticipate responses received to this RFI
will be highly beneficial to BARDA.

Sincerely,

Matthew A. McCord
Head of Acquisitions & Partnerships, DRIVe
Division of Contracts Management & Acquisition (CMA)
Biomedical Advanced Research & Development Authority (BARDA)
Administration for Strategic Preparedness and Response (ASPR)
U.S. Department of Health and Human Services (DHHS)
Attachment 1: BARDA Accelerator Network 2.0 RFI: Draft
Solicitation for Comment

Biomedical Advanced Research and Development Authority

(BARDA) Call for Submissions for the BARDA Accelerator
Network 2.0

Month, Year Date

Biomedical Advanced Research Development Authority (BARDA)

Contracts Management & Acquisition (CMA)
400 7th Street, SW, Washington, DC 20024

MedicalCountermeasures.gov

RFI – Draft Solicitation for Comment Only

Contents
I. BACKGROUND ................................................................................................................................... 3
II. OBJECTIVES ...................................................................................................................................... 4
III. REQUIREMENTS .............................................................................................................................. 5
Program Management Requirements ............................................................................................................ 5
Program Operations Requirements ................................................................................................................ 5
IV. OTHER REQUIREMENTS ............................................................................................................. 10
Use Of Funds Limitation .............................................................................................................................. 10
Salary Rate Limitation .................................................................................................................................. 10
Accounting System ....................................................................................................................................... 10
V. ELIGIBILITY CRITERIA ................................................................................................................. 10
VI. AWARD INFORMATION – INTENT TO EXECUTE MULTIPLE AGREEMENTS .................. 11
Period Of Performance ................................................................................................................................. 12
Anticipated Funding ..................................................................................................................................... 12
VII. ACCESS TO RECORDS & FOREIGN OWNED INTERESTS .................................................... 12
Access To Records ....................................................................................................................................... 12
Foreign Owned Interests .............................................................................................................................. 12
VIII. RIGHTS RESERVED DURING THE SOLICITATION PROCESS ........................................... 12
IX. SUBMISSION OVERVIEW & INSTRUCTIONS .......................................................................... 13
X. PROPOSAL PREPARATION ........................................................................................................... 14
XI. QUESTIONS .................................................................................................................................... 19
XII. EVALUATION CRITERIA ........................................................................................................... 19
XIII. AWARD DECISION ..................................................................................................................... 22
XIV. APPENDIX .................................................................................................................................... 24

RFI – Draft Solicitation for Comment Only

 I. BACKGROUND
1 The Biomedical Advanced Research and Development Authority (BARDA) was established and
2 mandated by Congress as the organization within the Administration for Strategic Preparedness and
3 Response (ASPR) to catalyze innovation in advanced research and development (R&D), manufacturing,
4 and procurement of Medical Countermeasures (MCMs). MCMs are needed to prepare for and respond
5 to public health emergencies (PHEs) caused by chemical, biological, radiological, and nuclear (CBRN)
6 threats, pandemic influenza, and other emerging infectious diseases (e.g., COVID-19). The Division of
7 Research, Innovation, and Ventures (DRIVe) was established within BARDA to invest in and accelerate
8 the R&D of breakthrough early-stage technologies for PHEs by supporting the innovation ecosystem and
9 reduce the risks associated with commercialization and regulation. In 2018, DRIVe launched the
10 BARDA Accelerator Network, a partnership with 13 Accelerators across the country, to effectively
11 support early-stage innovations and the startups that are advancing them. The existing BARDA
12 Accelerator Network has supported health security innovation ecosystem and medical countermeasures
13 development by:

14 • Cultivating a community of those advancing the commercialization of health security products,

15 technologies, and innovations.
16 • Identifying and fostering innovations in health security product and technology development.
17 • Providing wrap-around services such as curriculum, technical and business advice to
18 organizations in the BARDA mission space, access to facilities and incubator spaces, and
19 integration services.
20 • Supporting BARDA health security companies as they navigate research, development, and
21 regulatory pathways.

22 Based on the lessons learned from the current BARDA Accelerator Network and the COVID-19 pandemic
23 regarding the importance of having agile and scalable mechanisms to support innovation, BARDA is
24 seeking partners for the next iteration of the BARDA Accelerator Network (BAN 2.0) to further optimize
25 and enhance the services provided by the Accelerator Network. With BAN 2.0, BARDA aims to further
26 enhance the global health security innovation ecosystem, optimize startup acceleration and wrap-around
27 services, and ultimately develop the Accelerator Network as a scalable infrastructure for
28 commercialization including active product development support, and validation capabilities during
29 regular operations as well as rapid response during public health emergencies.

30

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31 II. OBJECTIVES
32 BARDA is seeking partners (“Accelerator Hubs”) to build the next iteration of the BARDA Accelerator
33 Network (BAN 2.0) using BARDA’s Other Transaction Authority to foster the health security innovation
34 ecosystem with commercialization and wrap-around support and to enable rapid development, evaluation,
35 validation, and commercialization of medical countermeasures. BARDA envisions that BAN 2.0 will
36 support BARDA’s mission by addressing the following objectives/tasks:

37 • Support health security innovators, startups, and existing BARDA partners (“portfolio companies”)
38 by providing wrap-around accelerator services including entrepreneurship education and access to
39 technical and business/commercialization expertise and resources.
40 • Provide BARDA with product development capabilities to source, review, fund, accelerate, and
41 perform evaluation and validation of MCMs based on BARDA’s strategic priority.
42 • Build a rapid emergency response mechanism to fund and accelerate product development and
43 validation of MCMs that can be developed and deployed as quickly as possible in the event of a
44 public health emergency.

45 BARDA intends to enter into other transaction agreements with five or more Accelerator Hub
46 organizations with each Accelerator Hub providing resources and support focused on one of the following
47 Technology Areas:

48 • Therapeutics/Vaccine
49 • Diagnostics/Medical Device
50 • Digital Health
51 • Enabling Technologies (e.g. Biomanufacturing/Drug Development/Clinical Support)
52 • Focus on Special Population (e.g. Pediatrics, low resource settings)

53 Each Accelerator Hub can be an individual accelerator partner or a consortium of partners, although one
54 legal entity will need to be identified as the prime awardee for purposes of entering into an Agreement
55 with BARDA. It is anticipated that the Accelerator Hubs will provide funding and/or services to mission
56 relevant innovators and companies regardless of their physical location worldwide. Respondents may
57 apply to support more than one technology area, but each technology area response must be addressed in
58 a separate proposal. Proposals to multiple technology areas by a respondent will be assessed
59 independently, and only one technology area will be awarded to a single respondent. An Accelerator Hub
60 may not be awarded more than one agreement under this solicitation.

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61 III. REQUIREMENTS
62 Program Management Requirements
63 BARDA’s role in the Accelerator Network 2.0 will include coordination of efforts, oversight, and
64 supporting opportunities for Accelerator Hubs to collaborate, and share expertise, knowledge, and events
65 across the innovation community. The Accelerator Hub has the primary responsibility for designing and
66 executing programming and services as defined by BARDA in this section. Accelerator Hubs will be
67 responsible for coordinating activities approved under the award. The Accelerator Hub will be responsible
68 for developing achievable program plans, tracking all activities and processes, following the terms and
69 conditions of the agreement, and adhering to budget and approved reporting plans.

70 The Accelerator Hubs will be responsible for planning and participating collaboratively with BARDA
71 under this agreement. Through participation in regular teleconferences and/or face-to-face review
72 meetings, the Accelerator Hub will work with BARDA to make progress toward its goal of executing the
73 Accelerator Hubs’ work plans.

74 The following is a summary of the program requirements for Accelerator Hubs:

75 • Coordinate with BARDA on a regular basis to ensure alignment of the Accelerator Hub’s priorities
76 based on BARDA’s strategic priorities.
77 • Submit technical reports and deliverables, consistent with the Deliverables and Reporting
78 Requirements (Appendix A).
79 • Have in place fiscal and programmatic systems to document accountability and performance.

80 Program Operations Requirements

81 The requirements listed below are key components for services BARDA envisions of the Accelerator Hubs
82 as it pertains to Wrap Around Accelerator Services, Development, Evaluation, and Validation Services,
83 and Rapid Response Capability/Support during a PHE. Each Accelerator Hub will be required to provide
84 resources and support to innovators and companies developing products in one of the technology areas
85 listed below:

86 • Therapeutics/Vaccine
87 o Focus on next generation therapeutics and vaccine platforms.
88 • Diagnostics/Medical Devices
89 o Focus on diagnostics and devices to enable pathogen agnostic surveillance, detection, and
90 diagnosis especially at point of care and at home settings, and innovative medical devices

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 91 to improve the quality of casualty care, alert the potential of an adverse health condition,
92 simplifying collection or processing of testing samples, and novel respirator protective
93 devices.
94 • Digital Health
95 o Focus on development and application of digital health tools to empower people to respond
96 to health security threats and improve the continuum of clinical care.
97 • Enabling Tech (Biomanufacturing/Drug Development/Clinical Support)
98 o Focus on innovations in drug discovery and development, biomanufacturing innovations
99 to increase speed, capacity, portability, and scalability, and innovations to improve clinical
100 research and clinical care coordination.
101 • Special Population (Pediatrics and/or Low Resource Settings)
102 o Focus on innovations that can improve the detection, diagnosis, treatment, and inform
103 outcomes in pediatric/neonatal populations and/or enable health equity solutions to
104 traditionally underrepresented communities and low-resource settings. Respondents can
105 submit a proposal that focuses on both special populations or a single population.

106 Each Accelerator Hub respondent must demonstrate the capability to provide the following required
107 services. For example, competitive proposals may demonstrate advancement of or complement previous
108 and existing HHS programs such as the current BARDA Accelerator Network, CARB-X, NIH Point-of-
109 Care Technologies Research Network (POCTRN), NIH Rapid Acceleration of Diagnostics (RADx), and
110 the NIH Proof of Concept Network. In addition, there are several other external federal and private bench-
111 to-market commercialization programs that may be leveraged, built on and expanded to support the
112 mission of the Accelerator Hubs.

113 A. Wrap Around Accelerator Services

114 BARDA supports innovators and companies with various levels of expertise at various stages of
115 development. Respondents are required to design programs and offer services across all technology
116 readiness levels (TRL). Under BARDA direction, the Accelerator Hub will be required to work with
117 innovators and companies in the ecosystem including the BARDA portfolio companies to provide the
118 following services:

119 Outreach/Networking and Sourcing:

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120 • Identify and refer promising domestic and foreign based companies to address the specific needs
121 within BARDA’s mission. Each Accelerator hub will be expected to identify and refer
122 technologies on an ongoing basis and/or when requested by BARDA.
123 • Provide BARDA with access to expert panels and Key Opinion Leaders within the specific
124 technology area on an ongoing basis and/or when requested.
125 • Promote BARDA funding opportunities and provide outreach and networking opportunities on an
126 ongoing basis and/or when requested by BARDA.
127 • Connect product developers and technology innovators including BARDA portfolio companies
128 with a network of life-science and medical technology innovators, developers, collaborators,
129 investors, strategic partners, and other ecosystem partners.
130 • Provide market intelligence and strategic input to BARDA through market research and
131 engagement on an ongoing basis and/or when requested.

132 Entrepreneurship and Product Development Training and Education:

133 • Provide innovators from diverse background interested in developing medical countermeasures
134 with access to skills development, hands-on entrepreneurial experience, and networking
135 opportunities.
136 • Provide entrepreneurial educational opportunities on medical countermeasure product
137 development and commercialization activities required to move technologies to the next stage
138 including topics such as business development, fundraising and financing, regulatory,
139 reimbursement.
140 • Recognize and prioritize common gaps and needs across the medical countermeasure product
141 development community and develop training and education programming to address the needs.
142 • Develop and deliver curriculum for support to innovators, startups, and innovation ecosystem via
143 workshops, webinars, other modes of training and communication. The Accelerator Hub must
144 ensure curriculum and workshops are inclusive and cater to diverse audience including both US
145 and foreign based innovators and startups that aim to develop their innovations for the US market.
146 Support for international innovators may include topics such as soft-landing support, IP
147 management, identification of partnership and funding opportunities.
148 • Design and execute at least one health security focused experiential, curriculum and mentorship
149 driven accelerator cohort or competition every two years. These accelerator cohorts can be a
150 component of and/or be integrated with the Development, Evaluation, and Validation Services
151 requirement outlined below.

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152 Wraparound and Commercialization Services:

153 • Build a network of mentors, industry experts, key opinion leaders – which may include both
154 volunteers and paid consultants - with technical and business expertise that include but not limited
155 to scientific/technical, manufacturing, quality assurance, nonclinical, clinical, business
156 development, regulatory, reimbursement, intellectual property, legal, marketing, fundraising and
157 financing, and strategic partnerships.
158 • Provide necessary expertise, advice and feedback to innovators and companies in the ecosystem
159 including the BARDA portfolio companies in order to accelerate technology and product
160 development as well as mitigate risks inherent to startup companies
161 • Make connections to investors, corporate and strategic partners, and incubators, in addition to
162 BARDA engagement and funding opportunities.
163 • Additional support to innovators includes but is not limited to 1:1 coaching/ mentoring services,
164 grant writing support, and boot camps/accelerator programs focused on specific technology topics
165 defined by BARDA.
166
167 B. Development, Evaluation, and Validation (DEV) Services

168 Each Accelerator Hub will provide product development, evaluation, and validation support to innovators
169 and companies that cover a spectrum of technology readiness for its specific technology area of focus.
170 These DEV services may be provided through a combination of in-house efforts and/or collaborations with
171 relevant experts/partners. The general scope of effort for DEV services should include, but is not limited
172 to:

173 • In collaboration with BARDA, identify unmet needs in the BARDA portfolio. Develop, run, and
174 manage funding solicitation topics to address the needs. The solicitation could use grant, contract,
175 prize, challenge, competition, or other funding mechanisms. Each Accelerator Hub is expected to
176 run at least one funding solicitation each year and support multiple projects with the potential to
177 support additional projects based on BARDA’s needs and the availability of additional funding.
178 The number of projects funded has the ability to change or be negotiated based on the funding and
179 the scope of individual projects.
180 • For each project, the Accelerator Hub is required to source, review, award, and manage product
181 DEV services of these projects. The Accelerator Hubs are required to fund these projects at least
182 within 2 months from the receipt of applications. However, BARDA might require that projects
183 are funded within days and weeks on a case-by-case basis especially during emergency situations.
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184 • Distribute, manage, and support multiple concurrent individual DEV project awards.
185 • Provide project management support to the funded projects – at a minimum, quarterly review
186 including progress assessed against milestones. Accelerator Hubs are responsible for coordinating
187 with BARDA to make milestone-based go/no-go decisions. Accelerator Hubs have the purview
188 of terminating projects that fail to meet milestones and reallocating resources accordingly with
189 BARDA input.
190 • Provide both technical and wraparound and commercialization support and access to experts and
191 mentors for the funded projects.
192 • Develop partnerships with industry and other stakeholders to facilitate the translation and
193 commercialization of innovations.
194 • Provide independent usability, feasibility, and validation testing services to funded DEV projects
195 that have successfully achieved their milestones and if requested by BARDA for additional
196 BARDA portfolio companies. These services would vary based on the technology readiness level
197 of the individual project and could include both preclinical and clinical validation. Accelerator
198 Hubs can build these capabilities in-house or can collaborate with partner(s) that can provide them.
199
200 C. Rapid Response Capability

201 The development of MCMs against health security threats is an ongoing process in anticipation of future
202 scenarios where BARDA must be able to act and deploy resources rapidly, such as in the event of a future
203 PHE. Once a rapid response scenario is identified by BARDA, it is imperative to dramatically accelerate
204 the development of appropriate MCMs. In addition to providing DEV and wraparound services during
205 times of “steady state”, BARDA anticipates the Accelerator Hubs to leverage additional resources, engage
206 external partners, and develop a streamlined plan for scaling Accelerator Hub operations and outputs in
207 any situation deemed necessary to have a rapid response.

208 The Accelerator Hub will be required to demonstrate the know-how and capability to ramp up all
209 Accelerator Hub functions including wrap-around accelerator services and DEV (outlined in Sections III.A
210 and III.B above) to deliver rapid and scalable solutions in the event of a rapid response scenario. During a
211 scenario should BARDA choose to exercise the option of allocating significant additional funds (up to the
212 OTA agreement ceiling per Section VI) to the Accelerator Hub, it shall be able to boost its capability to
213 identify partners, deploy funds, and provide wrap-around and DEV support for rapid and scaled-up
214 services (both with internal capabilities and relevant external partnerships) in accordance with the
215 proposed Rapid Response Capability Activation Plan (Appendix I). The Accelerator Hubs will be required

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216 to effectively source, review, distribute, manage, and support multiple concurrent awards (in the 100s) to
217 meet aggressive USG timelines, in as little as 5 calendar days (from requirement release to award) during
218 a rapid response event.

219 IV. OTHER REQUIREMENTS

220 Use of Funds Limitation
221 Accelerator Hubs are prohibited from using HHS funds obligated to an Agreement under this solicitation
222 to conduct investment activities including, but not limited to, taking equity positions in any entity
223 supported under the BAN 2.0 program.

224 It is important to note that this does not prohibit the Accelerator Hub from taking equity positions in any
225 of the supported entities, but rather limits the use of HHS funds for these activities.

226 Salary Rate Limitation

227 HHS is bound by applicable appropriations laws that direct that certain HHS funds cannot be used to pay
228 extramural salaries at a rate more than Executive Level II ($212,100 as of the fiscal year 2023).
229 Accordingly, USG funds appropriated to HHS and received by the Accelerator Hub cannot be used to pay
230 salaries more than the federal Executive Level II salary.

231 It is important to note that this does not limit the amount of salary an Accelerator Hub may compensate an
232 individual, rather it limits the amount of salary that can be paid to an individual using HHS funds.

233 Accounting System

234 The respondent must demonstrate the ability to maintain an accounting system that is capable of tracking
235 the expenditures of USG funds and investments of those funds given the financial requirements of this
236 partnership.

237 V. ELIGIBILITY CRITERIA

238 All responsible sources capable of satisfying the U.S. Government’s needs may submit a proposal that
239 would be considered by BARDA. Respondents may include single entities or a consortium of partners. To
240 be eligible for evaluation, the respondent must:

241 • Must be a US-based entity1

1
If the Respondent is a consortium of partners, one legal entity will need to be identified as the prime. While
consortium members can be non-US-based entities, the prime entity must be a US-based entity. It is the
responsibility of the prime entity to disclose the identity of all entities in the consortium.
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242 • Demonstrate a record of providing wrap-around accelerator and commercialization services, and
243 product development, evaluation, and validation service.
244 • Have experience building a network of innovators, startups, investors, strategic partners, experts,
245 mentors, and other innovation ecosystem partners.

246 Respondents may submit more than one proposal, provided that each proposal is to support one specific
247 technology area (Therapeutics/Vaccines, Diagnostics/Medical Devices, Enabling Technologies Digital
248 Health, or Special Population (Pediatrics/Low Resource Setting)). Any Respondent’s individual proposal
249 proposing to support more than one specific technology area will be considered non-responsive. Multiple
250 proposals by the same respondent, each proposing a different specific technology area but using shared
251 core facilities and programs are acceptable and will be reviewed independently.

252 BARDA will NOT accept duplicate or highly overlapping proposals under review at the same time. This
253 means that the BARDA will not accept a proposal that has substantial overlap with another proposal
254 pending the outcome of the review of earlier submissions.

255 Former federal employees, fellows, or contractors who worked for BARDA on the Accelerator Network
256 within the previous year, at the time of the proposal submission, are ineligible to respond. In addition, any
257 individual who contributed to the creation of this announcement is ineligible to respond. All members of
258 the proposed team for the project (including any subcontractors or consultants) must certify whether their
259 organization, including its individual team members and proposed subcontractors or consultants, has
260 provided similar support to any U.S. Government agency. If a Respondent’s proposed team includes a
261 former BARDA federal employee or a member who has provided Accelerator Network support to BARDA
262 or another U.S. Government agency with whom BARDA engages, it is the responsibility of the
263 Respondent to disclose this information and demonstrate that no actual or potential conflict of interest
264 exists.

265

266 VI. AWARD INFORMATION – INTENT TO EXECUTE MULTIPLE

267 AGREEMENTS
268 BARDA intends to make at least one award per Technology Area (outlined in Section II), however,
269 reserves the right to add additional Technology Areas or fund multiple Accelerator Hubs in a single
270 Technology Area based on changing BARDA priorities. In the event no Agreements result from a single
271 Technology Area BARDA reserves the right to reopen the solicitation to call for additional submissions.

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272 Period of Performance
273 BARDA intends to make multiple awards (“Agreements”) from this solicitation to Respondents with an
274 initial anticipated period of performance of two years that can be extended for up to eight more years. It is
275 BARDA’s intent to enter into five or more Agreements that would be executed through BARDA’s “other
276 transaction” authority. Each initial Agreement will result in a two-year base period, with four additional
277 two-year option periods, subject to approval and availability of funds.

278 Anticipated Funding

279 The initial funding amount provided to each respondent under the Agreement will be in the range of $1.3
280 to $1.5 million per year to provide wrap-around accelerator and product development, evaluation, and
281 validation services as outlined in Section III for the first year of the two-year base period. BARDA may
282 provide additional funds for wrap-around accelerator and product DEV services up to the negotiated
283 ceiling amounts as established in the Agreement. Additionally, each Agreement is anticipated to include a
284 ceiling of $500 million under the Rapid Response Capability requirement as an option to add funds in the
285 event of a rapid response situation including, but not limited to, a future pandemic or public health
286 emergency.

287

288 VII. ACCESS TO RECORDS & FOREIGN OWNED INTERESTS

289 Access to Records
290 The USG, at its discretion, will have access to and the right to examine records of the Respondents per
291 normal course of the Other Transaction Agreement. BARDA may periodically request information from
292 the Accelerator Hubs, including information on subawardees and recipients of services funded by this
293 OTA, on technology, financial, and intellectual property (IP) progress to track impact, performance, and
294 progress, and to overcome roadblocks towards accomplishing mission

295 Foreign Owned Interests

296 The Respondent shall ensure that no foreign investment capital or interests from USG prohibited sources
297 list of Embargoed and Sanctioned countries, as defined by U.S. Departments of Treasury and Commerce,
298 are utilized by the Respondent.

299

300 VIII. RIGHTS RESERVED DURING THE SOLICITATION PROCESS

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301 BARDA reserves specific rights, in addition to rights by law or regulation, including but not limited to:

302 • The right to request additional, necessary documentation upon initial review. Such additional
303 information may include but is not limited to, a further detailed proposal, budgets, and
304 representations and certifications.
305 • The right not to select a Respondent’s Proposal for award.
306 • The right to remove a Respondent from consideration should (i) the respondent fails to reach an
307 agreement on terms, conditions, and cost within a reasonable time; (ii) the respondent fails to
308 provide requested additional information in a timely manner, or (iii) BARDA believes it is in the
309 best interests of the USG.

310 IX. SUBMISSION OVERVIEW & INSTRUCTIONS

311 All interested parties are required to notify BARDA of their intent to respond to this solicitation via email
312 by MONTH DAY, 2023 to BAN_Inquiries@hhs.gov. In the email, the Respondent must include
313 information on their organization including three to five examples of relevant experience, potential
314 partners and collaborators, and which technology area(s) they intend to apply for by MONTH DAY, 2023.

315 Submissions are due at 12:00PM ET on the due dates listed below for each technology area. BARDA
316 may adjust the closing date for submissions under any of the following technology areas through
317 amendment of this notice.

318 • Diagnostics/Medical Devices by Summer 2023 with the intention to make the award in
319 FY2023.
320 • Therapeutics/Vaccine by Summer 2023 with the intention to make the award in FY2023.
321 • Enabling Tech (Biomanufacturing/Drug Development/Clinical Support) by Summer 2023 with
322 the intention to make the award in FY2023.
323 • Digital Health by Fall 2023 with the intention to make the award in FY2024.
324 • Special Population (Pediatrics, Low Resource Settings) by Winter 2024 with the intention to
325 make the award in FY2024.

326 All proposals will be kept confidential and reviewed pursuant to the criteria established. Any interested
327 parties that respond to this solicitation will be deemed a Respondent. BARDA reserves the right to engage
328 with any Respondent, as necessary, to clarify information submitted in the proposal. Respondents not
329 selected for the award will be notified of the decision, but formal debriefings will not be offered.

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330 Respondents must be registered in the System for Award Management (SAM) to be eligible for the award
331 (NAICS: 541714). Registration can be completed here: https://www.sam.gov/

332 X. PROPOSAL PREPARATION

333 All proposal information in response to this solicitation is submitted at no cost or obligation to the
334 Government. Interested parties are responsible for adequately marking proprietary or competition-
335 sensitive information contained in their response.

336 Please submit a proposal consisting of a narrative (including figures, schematics, diagrams, graphics, etc.,
337 which must be labeled) that describes the organization’s capabilities, experience, and approach, to perform
338 the tasks and responsibilities outlined in sections 1 – 5 below. Please structure proposals in accordance
339 with the sections below.

340 1. Overview: Goals and Objectives for stated Technology Area

341 Identify the Technology Area the Respondent is applying for and describe

342 • How the Respondent will partner with BARDA to develop a program as a BAN 2.0 Accelerator
343 Hub
344 • Why the Respondent is interested in partnering with BARDA, and
345 • How the Respondent can help BARDA’s mission to save lives and protect Americans from 21st
346 century health security threats as a BAN 2.0 Accelerator Hub.
347 2. Prospectus of Relevant Experience

348 This section pertains to current and past performance. The Respondent must include detailed examples of
349 its relevant current and past performance. The Respondent should also include experience and past
350 performance of key personnel and collaborators who will deliver the objectives of the partnership. All
351 examples should stand on their own without the need for evaluators to do any external research outside of
352 what is provided in the proposal. Proper citations (weblinks, papers, presentations, etc.) and supporting
353 evidence are required in the following areas:

354 a. Experience delivering on the requirements outlines in Section III above

355 (a) Wrap-around Accelerator services
356 1. Outreach/Networking and Sourcing
357 2. Entrepreneurship and Product Development Education/Training
358 3. Wrap-around and Commercialization Services

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359 (b) Development, Evaluation, and Validation Services
360 (c) Rapid Response Capability
361 b. Experience in successfully identifying and transitioning R&D products from early
362 development to follow-on investment and eventual successful commercialization.
363 c. Experience supporting product development and commercialization with the intent to generate
364 a measurable scientific or social impact that has addressed an unmet need in the life sciences
365 and/or health security landscape.
366 d. Experience managing operational functions to meet and maintain requirements of the
367 proposed programming.
368 3. Key Personnel

369 Respondent should provide an overview of capabilities it possesses to source, provide wrap around
370 accelerator services, Development, Evaluation, and Validation, and rapid response services as described
371 in Section III in support of companies regionally, nationally, and internationally located. If the Respondent
372 does not currently have all the necessary capabilities, describe how the respondent plans to scale operations
373 to support Accelerator Hub activities and management.

374 a. Provide an overview of the key personnel and support staff (including key subcontractors,
375 consultants, etc.) who will be responsible for the management and operations of the
376 Accelerator Hub. Provide the following for each of the proposed personnel:
377 (a) Name
378 (b) Description of role, contribution, and proposed level of effort
379 (c) Relevant Experience
380 (d) CV/Resume (attached as an appendix)
381 b. Provide a detailed description of how the Respondent will protect against conflicts of interest,
382 if any exist. It is the Respondent’s responsibility to establish policies and manage all internal
383 conflicts of interest.
384 c. Provide a description of the Respondent’s existing facilities and infrastructure and any future
385 plans, if any, for scale-up to address this partnership.
386 4. Program Design and Technical Approach

387 Respondents should provide an overview of how they envision to support the following required
388 capabilities of the BARDA Accelerator Network Hub as identified in Section III.

389 a. Wrap Around Accelerator Services:

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390 (a) Sourcing – Describe how companies will be sourced and any unique processes the
391 Respondent will utilize to identify the best technologies relevant to BARDA’s
392 mission/impact areas. It is expected that deal sourcing and technology scouting will
393 occur nationally and internationally. The Respondent must also describe how
394 mentors, experts, and business/commercialization consultants will be sourced to
395 support each company. If the Respondent currently does not have these capabilities,
396 describe how the Respondent will develop and maintain the capabilities.
397 (b) Program Design and Execution – Describe how the Respondent aims to design
398 programming and services for companies at all levels of development across the
399 TRL scale. Outline any unique processes or components the Respondent will utilize
400 to ensure programmatic success to minimize technical and commercial risks and
401 maximize impact to companies in the programs.
402 (c) Wrap-around and commercialization services – Outline the kind and scope of wrap-
403 around and commercialization services that the Respondent will provide. Explain
404 which of these services will be provided in-house and, if any, the relevant partners
405 that will be leveraged to provide other services.
406 (d) Outline a sample budget justification and timeline (including operational cost and
407 estimates of hourly costs for consultants/external partners) for the above Sourcing,
408 Program Design and Execution, and wrap-around and commercialization services
409 including how many companies the Accelerator will support in a given fiscal year
410 given a budget ceiling of $500k each year allocated for the Wrap Around
411 Accelerator Services.
412 (e) Describe how the Respondent will provide market intelligence and strategic input
413 through market research and engagement with the entrepreneurial community to
414 help advance the USG and BARDA’s mission.
415 (f) Describe how the Respondent will define, track and report on BARDA mission-
416 related impact metrics.
417 b. Development, Evaluation, and Validation (DEV) Services:
418 (a) Describe how the Respondent will design a DEV funding program including a
419 description of the approach for sourcing, review, funding mechanisms, project
420 management, and validation services offered to the companies
421 (b) Describe how the Respondent will provide technical assistance to companies as
422 required in Section III. The approach should empower innovators with core
423 competencies for business and clinical feasibility assistance to increase the
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424 technology readiness level of their technology from concept to demonstration to
425 deployment. The Respondent should describe how their physical and virtual
426 environment/ support mechanisms will support innovators at all stages to develop,
427 evaluate, validate, and commercialize their products.
428 (c) Outline a sample budget justification and the timeline for the DEV support (outlined
429 in Section III) to companies, including how many funded projects and types of
430 projects the Accelerator will support in a given fiscal year given a base budget
431 ceiling of $1M. This budget should include any labor costs associated with key
432 personnel, project management support, and ongoing consulting/mentoring to
433 companies as well as the individual awards to the funded company/subcontractor.
434 c. Rapid Response Capability
435 (a) In the event of a rapid response scenario, describe how the Respondent will scale
436 and ramp up Accelerator Hub functions to deliver rapid and scalable solutions in a
437 scenario where BARDA chooses to exercise the option of allocating $500M to
438 provide rapid response support.
439 (b) Outline a sample budget justification and timeline for how the Respondent can scale
440 up support for both Wrap Around Accelerator Support and DEV services in the
441 event of an emergency – for the outline assume that BARDA allocates $100M and
442 requires the Accelerator Hub to support product DEV and wrap around accelerator
443 support services for up to 50 companies with milestone-driven funding.
444 (c) Outline the Respondent’s organization, partners, and collaborators technical
445 approach quickly pivot and accelerate the development and commercialization of
446 products and to scale up the facilities and expertise in a rapid response scenario such
447 as addressing any public health emergency needs.
448 (d) If the Respondent has existing partnerships/infrastructure to support, list the
449 partners within the Respondent’s ecosystem and describe how and for which
450 component they will support the capabilities required of the Accelerator Hub If no
451 partnerships/infrastructure exists, outline how the respondent aims to identify and
452 partner with external partners.
453 5. Cost/Price Proposal

454 It is anticipated that the pricing structure for each Agreement will consist of a base fixed price for (a)
455 Wrap-around Accelerator services ($500K per year), (b) a fixed price for Development, Evaluation, and
456 Validation services ($1M per year), and (c) a variably structured Rapid Response Capability element that

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457 may be fixed price, expenditure based or any appropriate model determined to be in the government’s best
458 interest. The ceiling on the overall award, is up to $500M over the course of the agreement and would be
459 largely determined by the needs of BARDA and availability of funds. Additionally indicate and describe
460 the proposed resource sharing/proposed contributions, which may consist of cash investment or in-kind
461 contributions expressed in U.S. dollars. Greater resource contributions will be considered favorably.

462 The Respondent shall submit the following Cost/Price Proposal volume as follows:

463 1. Written Cost/Price Proposal

464 2. Cost/Price Workbook

465 5.1 Written Cost/Price Proposal

466 The Written Cost/Price Proposal shall be provided in Word (.docx or .doc) or PDF and should detail all
467 the activities included in the proposed base fixed price for each service separately as outlined in Section
468 III and Section VI (i.e., Wrap-Around Accelerator Services, Development, Evaluation, and Validation and
469 Rapid Response Capability). This narrative response should illustrate the Respondent’s understanding of
470 the labor market and the appropriate labor mix and costs associated with the services above. Note, the
471 fixed amounts for each service area in this section should support all requirements as outlined in Section
472 III and all other administrative activities. It should be inclusive of, but not necessarily limited to:

473 • Program Management Support

474 o Managing operational functions to meet and maintain the requirements of the proposed
475 programming
476 o Monthly reporting requirements, meetings, and other deliverables
477 • Individual Projects under Development, Evaluation, and Validation (DEV) Services & Rapid
478 Response
479 o Sourcing, review, funding, and management of Individual Project Proposals as outlined
480 under Section III
481 o Project funding for funded company and validation services for relevant companies
482 o Wrap-around support for funded projects
483 o Provide project management support and project and deliverable oversight to individual
484 projects support

485 5.2 Cost/Price Workbook

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486 The Cost/Price Workbook shall be completed in the format provided in Attachment X – Cost/Price
487 Workbook template. The Respondent should submit any supporting documentation separately as necessary
488 to supplement the cost/price workbook.

489 All proposal information in response to this solicitation is submitted at no cost or obligation to the
490 Government. Interested parties are responsible for adequately marking proprietary or competition-
491 sensitive information contained in their response.

492

493 XI. QUESTIONS

494 Please submit all questions to BAN_Inquiries@hhs.gov. All questions submitted and accompanying
495 answers may be made public (but would be anonymized and contain no identifying information).

496

497 XII. EVALUATION CRITERIA

498 Eligibility Requirements
499 The eligibility requirements will be reviewed against the eligibility criteria defined in Section V of this
500 solicitation and as follows:

501 • Must be a US-based entity2

502 • Demonstrate a record of providing wrap-around accelerator and commercialization
503 services, and product development, evaluation, and validation service.
504 • Have experience building a network of innovators, startups, investors, strategic partners,
505 experts, mentors, and other innovation ecosystem partners.
506

507 If it is determined that the Respondent does not satisfy the eligibility requirements, the proposal will not
508 be evaluated. If it is determined the respondent does satisfy the eligibility requirement, the proposal will
509 be evaluated against the evaluation criteria for each of the Required Capabilities (Wrap Around
510 Accelerator Services; Development, Evaluation, and Validation; Rapid Response Capability).

511 Proposal Evaluation

2
If the Respondent is a consortium of partners, one legal entity will need to be identified as the prime. While
consortium members can be non-US-based entities, the prime entity must be a US-based entity. It is the
responsibility of the prime entity to disclose the identity of all entities in the consortium.
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512 BARDA will review submissions and conduct proposal evaluations by Technology Area, on a
513 rolling basis as outlined in Section IX. The Technology Areas are as follows:

514 • Therapeutics/Vaccine
515 • Diagnostics/Medical Devices
516 • Digital Health
517 • Enabling Tech (Biomanufacturing/Drug Development/Clinical Support)
518 • Special Population (Pediatrics, Low Resource Settings)

519 If it is determined the respondent is responsive, the proposal will be evaluated against the following
520 evaluation criteria listed below in descending order of importance for each required capability:

521 (a) Prospectus of Relevant Experience

522 (b) Company/ Organization Capabilities
523 (c) Program Design and Technical Approach
524 (d) Cost/Price Proposal

525 Prospectus of Relevant Experience

526 • Wrap Around Accelerator Services

527 o The proposal will be evaluated as to whether it demonstrates that their organization and
528 collaborators have the capability and prior experience of establishing and maintaining a
529 network of R&D capabilities and technical support that is suitable for accelerating health
530 security innovation as well as experience in performing the functions of a product
531 Accelerator. The proposal will also be evaluated as to whether it demonstrates experience
532 in successfully identifying and transitioning R&D products from early development to
533 follow-on investment and eventual successful commercialization.
534 • Development, Evaluation, and Validation Services
535 o The proposal should demonstrate that the Respondent’s organization and collaborators
536 have the capability and prior experience to accelerate the process for innovators to increase
537 the technical and business capabilities of their venture, with experience in how to transition
538 products through the evaluation and testing required for regulatory approval.
539 • Rapid Response Capability
540 o The proposal should demonstrate that their organization, partners, and collaborators have
541 the capability and prior experience to quickly pivot and accelerate the development and

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542 commercialization of products and to scale up the facilities and expertise to address the
543 Rapid Response Capability needs.
544 • Key Personnel Wrap Around Accelerator Services
545 o The proposal will be evaluated as to whether it demonstrates that Key Personnel and
546 support staff (including key subcontractors, consultants, etc.) have the capability and prior
547 experience of evaluating early-stage technologies from a business/commercialization,
548 scientific, and regulatory perspective to facilitate R&D investment decisions. The proposal
549 will also be evaluated as to whether it demonstrates that the Key Personnel have the
550 capability and prior experience to provide the functions of a product accelerator. Personnel
551 in place will be viewed more favorably over personnel that may need to be hired.
552 • Development, Evaluation, and Validation Services
553 o The proposal should demonstrate that the Key Personnel have the capability and prior
554 experience in -bringing early-stage technologies from development, evaluation, and testing
555 to regulatory approval. The applicant should also demonstrate that the key personnel have
556 the capability and prior experience in executing pilot funding programs for targeted product
557 development, testing, rapid prototyping support, and validation based on the individual
558 requirements of the project. Personnel in place will be viewed more favorably over
559 personnel that may need to be hired.
560 • Rapid Response Capability
561 o The proposal should demonstrate that they can identify the Key Personnel required to
562 achieve the goal of accelerated development and commercialization quickly and nimbly.
563 This should include a recruitment plan for adequate staffing and expertise.

564 Program Design and Technical Approach

565 • Wrap Around Accelerator Services

566 o The proposed program design and technical approach will be evaluated as to whether it is
567 viable, realistic, and capable of satisfying the goals outlined in Section III and in
568 accordance with Section X. The approach should foster and identify a promising early-
569 stage R&D portfolio of national health security products and technology innovation. It
570 should foster a physical and virtual environment that is programmed to increase
571 collaboration and spur product innovation. The approach should support the business and
572 entrepreneurial needs and development of innovators, providing wrap-around support
573 capabilities and services.

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574 • Development, Evaluation, and Validation Services
575 o The proposed program design and technical approach will be evaluated as to whether it is
576 viable, realistic, and capable of satisfying the goals outlined in Section III and in
577 accordance with Section X. The approach should empower innovators with core
578 competencies for business and clinical feasibility assistance to increase the technology
579 readiness level of their technology from concept to demonstration to deployment. The
580 proposal should describe how the Respondent’s physical and virtual environment will
581 support innovators at all stages to develop, assess, evaluates, and translate/commercialize
582 their products.
583 • Rapid Response Capability
584 o The proposed program design and technical approach will be evaluated as to whether it is
585 viable, realistic, and capable of satisfying the goals outlined in Section III and in
586 accordance with Section X. The applicant should consider the facilities, key personnel,
587 collaborators, and partners needed to meet the goal. The proposal should include written
588 commitments, and letters of support, and demonstrate prior experience in bringing multiple
589 parties together and forming alliances, which could demonstrate their ability to maximize
590 the acceleration of development and commercialization of MCM for a Public Health
591 Emergency. The proposal should include a leadership plan that clearly defines the roles of
592 key personnel, and how communications, partnerships, and collaborations will be
593 organized. Existing partnerships will be viewed more favorably over developing
594 relationships.

595 Cost/ Price Proposal

596 • The Government will evaluate the estimated cost/price proposed by the Respondent for
597 performing all the requirements outlined in this solicitation. This evaluation will include an
598 analysis of the proposed cost/price together with all the supporting cost/price information required
599 including the rationale for assumptions made. The Government will evaluate the cost/price
600 proposal for completeness and value to the Government.

601

602 XIII. AWARD DECISION

603 Proposals will be evaluated against the evaluation criterion in Section XII and comparatively within the
604 specific Technology Area to make a best value determination. BARDA expects to make one award per
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605 Accelerator Hub Technology Area to a Respondent who proposes the greatest overall value to the USG in
606 accomplishing its program objectives. BARDA reserves the right to engage with any of the Respondents
607 (in-person or via telecom), as necessary to make a best value determination, as part of this decision process.

608 Following this initial evaluation of each Technology Area, the Respondent whose submission appears to
609 offer the best value to the USG will be invited to enter negotiations with the intent to reach and execute an
610 Agreement. Through this process, if it is determined that the respondent does not offer the best value to
611 the USG or mutual agreement on the terms cannot be reached, another Respondent may be invited to enter
612 negotiations.

613 By engaging in this process, submitting a proposal to this announcement, or entering into an agreement
614 resulting from this announcement, Respondents acknowledge that non-federal personnel may participate
615 and provide input throughout the evaluation or contract administration process. All non-governmental
616 personnel who support BARDA are strictly bound by appropriate non-disclosure and conflict of interest
617 requirements. Respondents should not engage in any part of this process if they do not consent to the
618 participation of non-federal consultants as described in this subparagraph.

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619 XIV. APPENDIX
620 Appendix A: Deliverables and Reporting Requirements

621 The Accelerator Hub shall comply with the following BARDA standard Deliverable and Reporting
622 Requirements:

Deliverable Content Requirements and Reporting Frequency4

Description Instructions3
Kick Off Meeting Hub to develop Agenda and host an in- Kickoff meeting conducted
person or virtual kick-off meeting to within 10 business days of award.
discuss overall project objectives, key
personnel, deliverables, risks, schedule, Minutes are to be submitted
and funding/payment procedures. within 3 business days of
meeting.
Provide meeting minutes.
Ad-Hoc Project Team Hub to schedule and create an agenda. As needed for special topics,
Meetings Follow agenda mutually agreed upon in when specifically requested by
advance of the meeting. Hub to provide BARDA.
meeting minutes within 3 business days
from the date of the meeting.
Monthly Project A robust monthly report detailing the Due monthly. Due date TBD by
Progress Report status of the budget, project Hub aligning for monthly
performance (i.e., milestones reached), consistency. Hub report format is
and relevant data metrics. Include the acceptable with USG content
status of DEV projects, including requirements at a minimum.
milestone updates, delays, and risk Initial report delivered in
management. Feedback or revisions are Microsoft Word or equivalent for
to be incorporated in future reports. ease of edits and final in PDF for
USG record keeping.
Reports are recommended to include
the following Data metrics:
• Technology Scouting Metrics
(Names of companies engaged,
companies’ alignment with
BARDA areas of interest)
• Business and Technical
Consultation Metrics (Hours or
support provided by mentors,
SMEs, etc.)
• Updates on status of companies
(currently in program and
alumni)

3
Unless otherwise specified, Hub’s format is acceptable. Submissions may be in MS Office or PDF format.
Funding and scheduling information shall be in MS Excel and MS Project, respectively.
4
Unless otherwise specified, ALL deliverables shall be emailed to the Other Transaction Agreements Officer
(OTAO) and Other Transaction Technical Representative (OTTR) listed in the Agreement AND uploaded to the
USG-specified database/folder.
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 Deliverable Content Requirements and Reporting Frequency4
Description Instructions3
o Major Milestones
o Business and Technical
Updates (finding,
regulatory, commercial,
etc.)
Monthly Project Team The purpose is to review monthly Virtual. Monthly, approximately
Meetings progress report findings, any changes 5 business days after the monthly
since last month, and any projected report deliverable. 1-hour
issues or challenges. duration, hosted by the Hub.

Minutes are to be submitted

within 3 business days of the
meeting.
Monthly All-Hands The purpose of this meeting is to Virtually, Monthly. 1-hour
Meetings collaborate, network, and share duration, hosted by BARDA
information between hubs. The agenda
for each meeting will be decided by
BARDA. All Key Accelerator Hub
personnel are recommended to attend.
Project Budget Full detailed budget for entire Project, Status updated monthly to be
incorporating original proposal, submitted with monthly project
changes, current projections, and any progress report with summary
escalation in cost, with all applicable provided during monthly
sub-budgeted categories of total project meetings.
included as provided in proposal to
USG. Required format: Microsoft Excel
Key Performance The Hub will propose KPPs defining KPPs: submitted during contract
Parameters (KPP) top-level metrics as well as thresholds negotiations.
to reach minimally acceptable Performance evaluation: quarterly
performance and optimal or ideal level report, or as required by BARDA.
of performance and will conduct
periodic performance evaluation.
Project Action Items Actions identified throughout the Submitted if/as required with
List project, which are not tracked by some monthly project progress report.
other project management tool, and
which require follow up and monitoring
for completion, will be captured in an
Action Items List, or similar
list/tracking tool. List should contain
information regarding identification
date, target completion, responsible
individuals/groups, etc.
Rapid Response Hub will provide an activation plan that Final 60 days after award -
Capability Activation allows for a scalable surge capacity Annually thereafter
Plan (e.g., extended business hours) during a
declared Rapid Response scenario.
Annual Project High-level project progress review of Annually from the start of the
Progress Report overall objectives. Updated projections project. To review progress over
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 Deliverable Content Requirements and
Description Instructions3
against project expectations, including
risks and mitigation plans, should be
reported with respect to the previous
annual report. Summary of critical
changes that took place over the year.
Recommended to not exceed 20 pages.
Final Report Final report summarizing stated
objectives and the progress that was
achieved in meeting those objectives;
summary of risks incurred, impacts and
mitigation; quantitative discussion of
production improvements achieved;
financial summary of project; schedule
summary for project, comparing
original schedule to final schedule;
recommendations for path forward as
applicable.
Foreign Ownership, The FOCI plan will encompass the
Control or Influence necessary compliance and security as
(FOCI) Plan well as decision points for BARDA.
623 Specific formats, contents, and timelines for these reports will be finalized during negotiations.
RFI – Draft Solicitation for Comment Only
Reporting Frequency4
the previous 12 months. A Draft
is to be submitted 30 days after
the completion of each year of
performance. Within 15 days of
receipt, the Government will
provide review comments. The
Contractor shall respond within
15 days of receipt of comments.
Report format: Microsoft Word
and PDF
Initial submission to be submitted
30 days prior to the end of the
validation portion of the project.
Within 15 days of receipt, the
Government will provide review
comments. The Contractor shall
respond within 15 days of receipt
of comments.
If requested by BARDA, within
the first 90 days post-award, the
FOCI plan will be delivered to
BARDA for review and
acceptance. After the plan is
submitted, the Government will
provide review comments. The
Contractor shall respond within
15 days of receipt of comments.
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