BARDA Accelerator Network 2.0 - Solicitation_Amend 02 (9.8.23).pdf

FOUO – Source Selection Sensitive

Biomedical Advanced Research and Development Authority (BARDA) Call for Submissions for the BARDA Accelerator

Network 2.0

July 26, 2023

Biomedical Advanced Research Development Authority (BARDA)

Contracts Management & Acquisition (CMA)

400 7th Street, SW, Washington, DC 20024 www.drive.hhs.gov http://www.drive.hhs.gov/

Contents

I. BACKGROUND

II. OBJECTIVES

III. REQUIREMENTS

PROGRAM MANAGEMENT REQUIREMENTS

PROGRAM OPERATIONS REQUIREMENTS

IV. OTHER REQUIREMENTS

AVOIDING ORGANIZATIONAL CONFLICTS OF INTEREST (OCI)

USE OF FUNDS LIMITATION

SALARY RATE LIMITATION

ACCOUNTING SYSTEM

V. ELIGIBILITY CRITERIA

VI. AWARD INFORMATION – INTENT TO EXECUTE MULTIPLE AGREEMENTS

PERIOD OF PERFORMANCE

ANTICIPATED FUNDING

VII. ACCESS TO RECORDS & FOREIGN OWNED INTERESTS

ACCESS TO RECORDS

FOREIGN-OWNED INTERESTS

VIII. RIGHTS RESERVED DURING THE SOLICITATION PROCESS

IX. SUBMISSION OVERVIEW & INSTRUCTIONS

FAQ

X. PROPOSAL PREPARATION

XI. EVALUATION CRITERIA

ELIGIBILITY REQUIREMENTS

PROPOSAL EVALUATIONS

RATINGS

XII. AWARD DECISION

XIII. APPENDIX

BAN 2.0 Solicitation Amendment 02 (Sep 8, 2023)

I. BACKGROUND

1 The Biomedical Advanced Research and Development Authority (BARDA) within the Administration

2 for Strategic Preparedness and Response (ASPR) was established and mandated by Congress to catalyze

3 innovation in research and development (R&D), manufacturing, and procurement of Medical

4 Countermeasures (MCMs) against health security threats. 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 fund and accelerate the

8 R&D of breakthrough early-stage technologies for PHEs and support 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 current 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 wraparound services such as startup-focused curriculum, technical and business

18 mentorship, access to facilities and incubator spaces, and integration services to organizations

19 aligned with the BARDA’s mission

20 • Supporting health security companies in the BARDA mission space as they navigate research, 21 development, and 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 wraparound

27 services, and ultimately develop the Accelerator Network as a scalable infrastructure for product

28 development and commercialization by supporting active product development and validation capabilities

29 during regular operations as well as during a rapid response scenario, such as a public health emergency.

32 II. OBJECTIVES

33 BARDA is seeking partners (“Accelerator Hubs”) to build the next iteration of the BARDA Accelerator

34 Network (BAN 2.0) using BARDA’s Other Transaction authority to foster the health security innovation

35 ecosystem with commercialization and wraparound support and to enable rapid development, evaluation, 36 validation, and commercialization of medical countermeasures. BARDA envisions that BAN 2.0 will

37 support BARDA’s mission by addressing the following objectives/tasks:

38 • Support health security innovators, startups, and existing BARDA partners already receiving

39 BARDA funding (“BARDA funded partners”1) by providing wraparound accelerator services

40 including entrepreneurship education and access to technical and business/commercialization

41 expertise and resources.

42 • Provide BARDA with capabilities to source, review, fund, and accelerate startups and perform

43 product development, evaluation, and validation of MCMs based on BARDA’s strategic priorities.

44 • Build a rapid emergency response infrastructure to fund and accelerate product development and

45 validation of MCMs that can be developed and deployed as quickly as possible in the event of a

46 public health emergency.

47 BARDA intends to enter into other transaction agreements with five or more Accelerator Hub

48 organizations with each Accelerator Hub providing resources and support focused on one of the following

49 technology areas:

50 • Therapeutics/Vaccines

51 • Diagnostics/Medical Devices

52 • Digital Health

53 • Enabling Technologies (e.g., Biomanufacturing, Drug Development, Clinical Support)

54 • Special Populations (e.g., Pediatrics, Immunocompromised, Low resource settings)

55 Each Accelerator Hub can function individually or as a consortium of partners, although one legal entity

56 will need to be identified as the prime awardee for purposes of entering into an Agreement with BARDA.

57 It is anticipated that the Accelerator Hubs will provide funding and/or services to mission relevant

58 innovators and companies regardless of their physical location worldwide. Respondents may apply to

59 support more than one technology area, but each technology area response must be addressed in a separate

1 BARDA funded partners include any organizations, labs, universities, and startups currently in partnership with BARDA

60 proposal. If a Respondent submits a separate proposal for each technology area, each proposal will be

61 assessed independently.

62 III. REQUIREMENTS

63 Program Management Requirements

64 BARDA’s role in BAN 2.0 will include providing funding, coordination of efforts, oversight, and

65 supporting opportunities for Accelerator Hubs to collaborate, and share expertise, knowledge, and events

66 across the innovation community.

67 The Accelerator Hub has the primary responsibility for designing and executing programming and services

68 as defined by BARDA in this section. Accelerator Hubs will be responsible for coordinating activities

69 approved under the award. The Accelerator Hub will be responsible for developing achievable program

70 plans, tracking all activities and processes, following the terms and conditions of the agreement, and

71 adhering to budget and approved reporting plans. The Accelerator Hubs will be responsible for planning

72 and participating collaboratively with BARDA under this agreement. Through participation in regular

73 teleconferences and/or face-to-face review meetings, the Accelerator Hub will work with BARDA to make

74 progress toward its goal of executing the Accelerator Hubs’ work plans.

75 The following is a summary of the general program requirements for Accelerator Hubs to manage a

76 prospective partnership with BARDA:

77 • Coordinate with BARDA on a regular basis to ensure alignment of the Accelerator Hub’s priorities

78 based on BARDA’s strategic priorities.

79 • Submit technical reports and deliverables, consistent with the Deliverables and Reporting

80 Requirements (Appendix A).

81 • Maintain fiscal and programmatic systems to document accountability and performance.

82 Program Operations Requirements

83 The requirements listed below are key components for services BARDA envisions of the Accelerator Hubs

84 as it pertains to Wraparound Accelerator Services, Development, Evaluation, and Validation Services, and

85 Rapid Response Capability/Support during a rapid response scenario, including a PHE. Each Accelerator

86 Hub will be required to provide resources and support to innovators and companies developing products

87 in one of the technology areas listed below (individual Hub focuses subject to change based on BARDA’s

88 priorities):

89 • Therapeutics/Vaccines

90 o Focus on next-generation therapeutic and vaccine platforms.

91 • Diagnostics/Medical Devices

92 o Focus on diagnostics and devices to enable pathogen-agnostic surveillance, detection, and

93 diagnosis, especially at point-of-care and at-home settings, and innovative medical devices

94 to improve the quality of casualty care, alert the potential of an adverse health condition, 95 simplify collection or processing of testing samples, and protect respiratory health.

96 • Digital Health

97 o Focus on development and application of digital health tools to empower people to prepare

98 for and respond to health security threats and improve the continuum of clinical care.

99 • Enabling Technologies (e.g., Biomanufacturing/Drug Development/Clinical Support)

100 o Focus on innovations in drug discovery and development, biomanufacturing innovations

101 to increase speed, capacity, portability, and scalability, and innovations to improve clinical

102 research and clinical care coordination.

103 • Special Populations (e.g., Pediatrics and/or Immunocompromised and/or Low Resource Settings)

104 o Focus on innovations that can improve the detection, diagnosis, treatment, and inform

105 outcomes in pediatric/neonatal populations and/or immunocompromised populations

106 and/or enable health equity solutions to traditionally underrepresented communities and

107 low-resource settings. Respondents can submit a proposal that focuses on all special

108 populations or a single population.

109 Accelerator Hub respondent(s) must demonstrate the capability to provide Wraparound Accelerator

110 Services, DEV Services, and Rapid Response Capability services as detailed below. For example, 111 competitive proposals may demonstrate advancement of or having complemented previous and existing

112 HHS programs such as the current BARDA Accelerator Network, CARB-X, NIH Point-of-Care

113 Technologies Research Network (POCTRN), NIH Rapid Acceleration of Diagnostics (RADx), and the

114 NIH Proof of Concept Network. In addition, there are several other external federal and private bench-to-

115 market commercialization programs that may be leveraged, built on, and expanded to support the mission

116 of the Accelerator Hubs.

117 A. Wraparound Accelerator Services

118 BARDA supports innovators and companies with various levels of expertise at various stages of

119 development. Respondents are required to design programs and offer services across all technology

120 readiness levels (TRL). Under BARDA direction, the Accelerator Hub will be required to work with

121 innovators and companies in the ecosystem, including BARDA funded partners, to provide the following

122 services:

123 Outreach/Networking and Sourcing:

124 • Identify and refer promising domestic and foreign-based companies to address the specific needs

125 within BARDA’s mission. Each Accelerator hub will be expected to identify and refer

126 technologies on an ongoing basis and/or when requested by BARDA.

127 • Provide BARDA with key opinion leaders and expert panels within the specific technology area

128 on an ongoing basis and/or when requested.

129 • Promote BARDA funding opportunities and provide outreach and networking opportunities on an

130 ongoing basis and/or when requested by BARDA.

131 • Connect product developers and technology innovators including BARDA funded partners with a

132 network of life science and medical technology innovators, developers, collaborators, investors, 133 strategic partners, and other ecosystem partners.

134 • Provide market intelligence and strategic input to BARDA through market research and

135 engagement on an ongoing basis and/or when requested.

136 Entrepreneurship and Product Development Training and Education:

137 • Provide a diverse range of innovators interested in developing medical countermeasures access to

138 skills development, hands-on entrepreneurial experience, and networking opportunities.

139 • Provide entrepreneurial educational opportunities on medical countermeasure product

140 development and commercialization activities required to move technologies to the next stage

141 including topics such as business development, fundraising and financing, regulatory pathways, 142 and reimbursement.

143 • Recognize and prioritize common gaps and needs across the medical countermeasure product

144 development community and develop training and education programming to address the needs.

145 • Develop and deliver curriculum for support to innovators, startups, and innovation ecosystem via

146 workshops, webinars, other modes of training and communication. The Accelerator Hub must

147 ensure curriculum and workshops are inclusive and cater to diverse audiences including both US

148 and foreign-based innovators and startups that aim to develop their innovations for the US market.

149 Support for international innovators may include topics such as soft-landing support, IP

150 management, and identification of partnership and funding opportunities.

151 • Design and execute at least one health security-focused experiential, curriculum, and mentorship-

152 driven accelerator cohort or competition every two years, subject to exercise of relevant option(s).

153 These accelerator cohorts can be a complement of and/or be integrated with the Development, 154 Evaluation, and Validation Services requirement outlined below.

155 Wraparound and Commercialization Services:

156 • Build a network of mentors, industry experts, and key opinion leaders with technical and business

157 expertise that includes, but is not limited to, scientific/technical, manufacturing, quality assurance, 158 nonclinical, clinical, business development, regulatory, reimbursement, intellectual property, 159 legal, marketing, fundraising/financing, and strategic partnerships.

160 • Provide necessary expertise, advice and feedback to innovators and companies in the ecosystem, 161 including the BARDA funded partners, to accelerate technology and product development as well

162 as mitigate risks inherent to startup companies.

163 • Make connections to investors, corporate and strategic partners, and incubators, in addition to

164 BARDA engagement and funding opportunities.

165 • Provide additional support to innovators including, but not limited to, 1:1 coaching/ mentoring

166 services, grant writing support, and boot camps/accelerator programs focused on specific

167 technology topics defined by BARDA.

169 B. Development, Evaluation, and Validation (DEV) Services

170 Each Accelerator Hub will provide product DEV services to support innovators and companies that cover

171 a spectrum of technology readiness for its specific technology area of focus. These DEV services may be

172 provided through a combination of in-house efforts and/or collaborations with relevant experts/partners.

173 The general scope of effort for DEV services will include, but is not limited to:

174 • In collaboration with BARDA, identify unmet needs in the BARDA portfolio. Develop, run, and

175 manage funding solicitation topics to address the needs. Solicitations issued by an Accelerator

176 Hub could result in subawards structured similar to grants, contracts, prizes, challenges, 177 competitions, or other mechanisms as allowable under BARDA authorities. Subject to the exercise

178 of options for DEV services , each Accelerator Hub will be expected to run at least one funding

179 solicitation each year and support multiple projects with the potential to support additional projects

180 based on BARDA’s needs and the availability of additional funding. The number of projects

181 funded could change or be negotiated based on the funding and the scope of individual projects.

182 • For each project, the Accelerator Hub is required to source, review, award, and manage product

183 DEV services. The Accelerator Hubs are required to launch these projects within 2 months or less

184 from the receipt of project applications. However, BARDA might require that projects are funded

185 within days or weeks on a case-by-case basis, especially during emergency situations.

186 • Distribute, manage, and support multiple concurrent individual DEV project awards.

187 • Provide project management support to the funded projects – at a minimum, quarterly review

188 including progress assessed against established milestones. Accelerator Hubs are responsible for

189 coordinating with BARDA to make milestone-based go/no-go decisions. Accelerator Hubs may

190 terminate projects that fail to meet milestones and reallocate resources accordingly with input from

191 BARDA.

192 • Provide both technical and wraparound and commercialization support and access to experts and

193 mentors for the funded projects.

194 • Develop partnerships with industry and other stakeholders to facilitate the transition and

195 commercialization of innovations.

196 • Provide independent usability, feasibility, and validation testing services to funded DEV projects

197 that have successfully achieved their milestones and if requested by BARDA for additional

198 BARDA funded partners. These services would vary based on the technology readiness level of

199 the individual project and could include both preclinical and clinical validation. Accelerator Hubs

200 can build these capabilities in-house or can collaborate with partner(s) that can provide them.

202 C. Rapid Response Capability

203 The development of MCMs against health security threats is an ongoing process in anticipation of future

204 scenarios where BARDA must be able to act and deploy resources rapidly, such as in the event of a future

205 PHE. Once a rapid response scenario is identified by BARDA, it is imperative to dramatically accelerate

206 the development of appropriate MCMs. In addition to providing DEV and wraparound services during

207 times of “steady state”, BARDA expects the Accelerator Hubs to leverage additional resources, engage

208 external partners, and develop a streamlined plan for scaling Accelerator Hub operations and outputs in

209 any situation deemed necessary to require a rapid response from BARDA.

210 The Accelerator Hub will be required to demonstrate the know-how and capability to ramp up all

211 Accelerator Hub functions including wraparound accelerator services and DEV (outlined in Sections III.A

212 and III.B above) to deliver rapid and scalable solutions in the event of a rapid response scenario. During a

213 scenario, should BARDA choose to exercise the option of allocating significant additional funds (up to 214 the OTA agreement ceiling per Section VI) to the Accelerator Hub, the Hub needs to be able to boost its

215 capability to identify partners, deploy funds, and provide wraparound support for rapid and scaled-up

216 services (both with internal capabilities and relevant external partnerships). The Accelerator Hubs will

217 be required to effectively source, review, distribute, manage, and support multiple concurrent awards

218 (potentially in the 100s) to meet aggressive USG timelines, in as little as 5 calendar days (from

219 requirement release to award) during a rapid response event.

220 IV. OTHER REQUIREMENTS

221 Avoiding Organizational Conflicts of Interest (OCI)

222 Respondents must disclose whether any members of the proposed team for the project (including any

223 subcontractors or consultants) including its individual team members and proposed subcontractors or

224 consultants, has provided similar support to any U.S. Government agency or are currently providing

225 professional consulting services2 to any part of the USG. Respondents must also disclose and certify if

226 any individual member of their proposed team has provided professional consulting services previously

227 to ASPR/BARDA within the previous three years from the date of the release of this solicitation. A

228 determination will then be made in BARDA’s best business judgment as to whether a respondent has a

229 conflict of interest and whether an appropriate mitigation plan is feasible. If this relationship is

230 determined to create a conflict of interest that cannot be mitigated, then the individual or entity will be

231 ineligible to be a part of the proposal. Current or former BARDA personnel (federal employees, fellows, 232 or support contractors) who worked for BARDA on the Accelerator Network within the previous year or

233 at the time of the proposal submission, are ineligible to respond. In addition, any individual who

234 contributed to the creation of this announcement is ineligible to respond.

235 As part of the proposal submission, all members of the proposed team (including any potential

236 subcontractors or consultants) must affirm if their organizations and/or individual team members have

237 provided any professional consulting services in support of any USG agency in the past three years. This

238 includes a former BARDA employee or a member who has provided Accelerator Network support to

239 BARDA or another U.S. Government agency with whom BARDA engages. It is the responsibility of the

2 In this context, “professional consulting services” refers to services where individuals support USG programs which award federal funding in the research & development or health science space. These services are often referred to as “Subject Matter Experts (“SME”); “Scientific, Engineering, Technical Assistance (“SETA”) Services; Joint Oversight and Assistance Services (“A&AS”); or similar support type roles.

NOTE: In this context, “professional consulting services” does not include individuals working at companies performing R&D or other contracts/grants/Other Transactions where the individuals do not support/advise government personnel as part of their agreement. Having previously received federal funding does NOT necessarily preclude an interested party from being considered under this solicitation.

240 Respondent to disclose this information and demonstrate that no actual or potential conflict of interest

241 exists. Adequate information about the services rendered must be provided to allow BARDA to make

242 this determination.

243 If professional consulting services are currently, or have been, provided to any USG program(s) by a

244 member of a proposed team, the proposal must include the following:

245 a) The name of the USG program office receiving the support

246 b) The contract, grant, agreement, etc., number

247 c) Identification of proposed team member (e.g., sub-awardee, consultant) providing the support

248 d) A comprehensive OCI mitigation plan.

251 Use of Funds Limitation

252 Accelerator Hubs are prohibited from using HHS funds obligated to an Agreement under this solicitation

253 to conduct investment activities including, but not limited to, taking equity positions in any entity

254 supported under the BAN 2.0 program.

255 It is important to note that this does not prohibit the Accelerator Hub from taking equity positions in any

256 of the supported entities, but rather limits the use of HHS funds for these activities.

257 Salary Rate Limitation

258 HHS is bound by applicable appropriations laws that direct that certain HHS funds cannot be used to pay

259 extramural salaries at a rate more than Executive Level II ($212,100 as of the fiscal year 2023).

260 Accordingly, USG funds appropriated to HHS and received by the Accelerator Hub cannot be used to pay

261 salaries more than the federal Executive Level II salary.

262 It is important to note that this does not limit the amount of salary an Accelerator Hub may compensate an

263 individual, rather it limits the amount of salary that can be paid to an individual using HHS funds.

264 Accounting System

265 The respondent must demonstrate the ability to maintain an accounting system that is capable of tracking

266 the expenditures of USG funds and investments of those funds given the financial requirements of this

267 partnership.

268 V. ELIGIBILITY CRITERIA

269 All responsible sources capable of satisfying the U.S. Government’s needs may submit a proposal that will

270 be considered by BARDA. Respondents may include single entity or a consortium of partners. To be

271 eligible for evaluation, the respondent (either individual entity or a consortium of partners) must, at a

272 minimum:

273 • Demonstrate a record of providing wraparound accelerator and commercialization services, and

274 product development, evaluation, and validation services.

275 • Have experience building a network of innovators, startups, investors, strategic partners, experts, 276 mentors, and other innovation ecosystem partners.

277 Respondents may submit more than one proposal, provided that each proposal is to support a hub for one

278 specific technology area (Therapeutics/Vaccines, Diagnostics/Medical Devices, Enabling Technologies, 279 Digital Health, or Special Populations. Each proposal should focus on one specific technology area Hub.

280 Multiple proposals by the same respondent, each proposing a different specific technology area but using

281 shared core facilities and programs are acceptable and will be reviewed independently.

282 BARDA will not accept duplicate or highly overlapping proposals.

283 VI. AWARD INFORMATION – INTENT TO EXECUTE MULTIPLE

284 AGREEMENTS

285 BARDA intends to make at least one award per technology area (outlined in Section II), however, reserves

286 the right to add additional technology areas or fund multiple Accelerator Hubs in a single technology area

287 based on changing BARDA priorities. BARDA reserves the right to reopen the solicitation to call for

288 additional submissions.

289 Period of Performance

290 BARDA anticipates executing multiple awards (“Agreements”) from this solicitation to Respondents with

291 each Agreement expected to result in a two-year base period with additional option periods up to 10 years, 292 to be exercised at BARDA’s discretion and subject to availability of funds. It is BARDA’s intent to enter

293 into five or more Agreements (at least one for each technology area) that would be executed through

294 BARDA’s “Other Transaction” authority.

295 Anticipated Funding

296 The initial base funding amount provided to each respondent for each technology area Hub under the

297 Agreement will be $1.5 million. The base funding will be used by the respondent to provide program

298 management services, wraparound accelerator, DEV services, and project management costs as outlined

299 in Section III. In addition, BARDA’s intention is to structure an agreement which contains annual funding

300 options for continuing wraparound and DEV services in the aggregate amount of $1.5 million.

301 Additionally, agreements will be structured to be able to exercise annual or other options at higher

302 amounts. Each Agreement is anticipated to include a ceiling of $500 million over the period of the

303 Agreement. BARDA may provide funds for additional wraparound and product DEV services beyond the

304 base amount up to the negotiated ceiling amounts as established in the Agreement based on BARDA’s

305 priorities and needs and in the event of a rapid response situation including, but not limited to, a future

306 pandemic or public health emergency.

307 Respondents are encouraged to propose cost/resource sharing/ contributions, which may consist of cash

308 investment or in-kind contributions expressed in U.S. dollars. Greater cost/resource contributions will be

309 considered favorably.

310 VII. ACCESS TO RECORDS & FOREIGN OWNED INTERESTS

311 Access to Records

312 The USG, at its discretion, will have access to and the right to examine records of the Respondents per

313 normal course of the Other Transaction Agreement. BARDA may periodically request information from

314 the Accelerator Hubs, including information on subawardees and recipients of services funded by this

315 OTA, on technology, financial, and intellectual property (IP) progress to track impact, performance, and

316 progress, and to overcome roadblocks towards accomplishing its mission.

317 Foreign-Owned Interests

318 The Respondent shall ensure that no foreign investment capital or interests from USG prohibited sources

319 list of Embargoed and Sanctioned countries3, as defined by U.S. Departments of Treasury and Commerce, 320 are utilized by the Respondent.

321 VIII. RIGHTS RESERVED DURING THE SOLICITATION PROCESS

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

323 • The right to request additional, necessary documentation upon initial review. Such additional

324 information may include but is not limited to, a further detailed proposal, budgets, and

325 representations and certifications.

326 • The right not to select a Respondent’s proposal for award.

3 US Department of Treasury, Office of Foreign Assets Control, Sanctions List Search: https://sanctionssearch.ofac.treas.gov/

327 • The right to remove a Respondent from consideration should (i) the Respondent fails to reach an

328 agreement on terms, conditions, and cost within a reasonable time; (ii) the Respondent fails to

329 provide requested additional information in a timely manner, or (iii) BARDA believes it is in the

330 best interests of the USG.

331 • The right to evaluate and award an Agreement without negotiations with a Respondent.

332 IX. SUBMISSION OVERVIEW & INSTRUCTIONS

333 All interested parties are requested to 1) submit all solicitation related questions and 2) notify BARDA

334 of their intent to respond to this solicitation via email by at least 15 days prior to the respective Hub

335 response deadline below to BAN_Inquiries@hhs.gov. In the email, the Respondent must include

336 information on their organization including: 1) three to five examples of relevant experience performing

337 the services as outlined under Section III, specifically Wraparound Accelerator Services, DEV Services, 338 and Rapid Response Capability services, 2) potential partners and collaborators, and 3) the technology

339 area(s) to which they intend to apply.

340 Submissions are due at 12:00PM ET on the due dates listed below for each technology area. BARDA

341 may adjust the closing date for submissions under any of the following technology areas through

342 amendment of this notice.

343 • Diagnostics/Medical Devices on September 15, 2023, with the intent to make an award within 90-

344 120 days of the proposal due date.

345 • Therapeutics/Vaccines on October 2, 2023, with the intent to make an award within 90-120 days

346 of the proposal due date.

347 • Enabling Technologies on October 2, 2023, with the intent to make an award within 90-120 days

348 of the proposal due date.

349 • Digital Health on January 12, 2024, with the intent to make an award within 90-120 days of the

350 proposal due date.

351 • Special Populations (e.g., Pediatrics, Immunocompromised, Low Resource Settings) on January

352 12, 2024, with the intent to make an award within 90-120 days of the proposal due date.

353 All proposals will be kept confidential and reviewed pursuant to the criteria established. Any interested

354 parties that respond to this solicitation will be deemed a Respondent. BARDA reserves the right to engage

355 with any Respondent, as necessary, to clarify information submitted in the proposal. Respondents not

356 selected for the award will be notified of the decision, but formal debriefings will not be offered.

mailto:BAN_Inquiries@hhs.gov

357 Respondents must be registered in the System for Award Management (SAM) to be eligible for the award

358 (NAICS: 541714). Registration can be completed here: https://www.sam.gov/

359 FAQ

360 Please reference Attachment 2 – FAQ for BAN 2.0 Solicitation for additional details.

361 X. PROPOSAL PREPARATION

362 All proposal information in response to this solicitation is submitted at no cost or obligation to the

363 Government.

364 Please submit a proposal consisting of a narrative (including figures, schematics, diagrams, graphics, etc., 365 which must be labeled) that describes the organization’s capabilities, experience, and approach, to perform

366 the tasks and responsibilities outlined in sections 1 – 5 below. Please structure proposals in accordance

367 with the sections below.

368 1. Overview: Goals and Objectives for Technology Area Hub

369 Identify the technology area the Respondent (single entity or a consortium of partners) is applying for and

370 describe

371 • How the Respondent will partner with BARDA to develop a program as a BAN 2.0 Accelerator

372 Hub (if submitting as a consortium, highlight the value of the proposed team)

373 • Why the Respondent is interested in partnering with BARDA, 374 • How the Respondent can help BARDA’s mission to save lives and protect Americans from 21st

375 century health security threats as a BAN 2.0 Accelerator Hub, and

376 • Summary of the qualitative and quantitative metrics and outcomes that the respondent aims to

377 achieve over the period of the Agreement

378 2. Summary of Relevant Experience

379 This section pertains to current and past performance. The Respondent (single entity or a consortium of

380 partners) must include detailed examples of its relevant current and past performance. The Respondent

381 should also include experience and past performance of the organization, key personnel and collaborators

382 who will deliver the objectives of the partnership. All examples should stand on their own without the

383 need for evaluators to do any external research outside of what is provided in the proposal. Proper citations

384 (weblinks, papers, presentations, etc.) and supporting evidence are required in the following areas:

385 a. Experience delivering on the requirements outlines in Section III above http://www.sam.gov/

386 (a) Wraparound Accelerator services

387 1. Outreach/Networking and Sourcing

388 2. Entrepreneurship and Product Development Education/Training

389 3. Wraparound and Commercialization Services

390 (b) DEV Services

391 (c) Rapid Response Capability

392 b. Experience in successfully identifying and transitioning R&D products from early

393 development to follow-on investment and eventual successful commercialization.

394 c. Experience supporting product development and commercialization with the intent to generate

395 a measurable scientific or social impact that has addressed an unmet need in the life sciences

396 and/or health security landscape.

397 d. Experience managing operational functions to meet and maintain requirements of the

398 proposed programming.

400 3. Organization Capabilities and Key Personnel

401 Respondent (single entity or consortium of partners) should provide an overview of the capabilities it

402 possesses to source innovators and companies, provide Wraparound Accelerator services, DEV, and Rapid

403 Response services as described in Section III in support of both national and international companies

404 aligned with BARDA’s mission. If the Respondent does not currently have all the necessary capabilities, 405 describe how the Respondent plans to scale operations to support Accelerator Hub activities and

406 management.

407 a. Provide an overview of the key personnel and support staff (including key subcontractors, 408 consultants, etc.) who will be responsible for the management and operations of the

409 Accelerator Hub. Provide the following for each of the proposed personnel:

410 (a) Name

411 (b) Description of role, contribution, and proposed level of effort

412 (c) Relevant Experience

413 (d) CV/Resume (attached as an appendix, 1-3 pages, no particular format required)

414 b. Provide a detailed description of how the Respondent will avoid conflicts of interest, if the

415 potential for any exists. It is the Respondent’s responsibility to establish policies and manage

416 all internal conflicts of interest.

417 c. Provide a description of the Respondent’s existing facilities and infrastructure and any future

418 plans, if any, for scale-up to address this partnership.

419 Although not a requirement, proposals from US-based entities will be given preference.

420 4. Program Design and Technical Approach

421 Respondents (single entity or consortium of partners) should provide an overview of how they envision to

422 support the following required capabilities of the BARDA Accelerator Network Hub as identified in

423 Section III:

424 a. Wrap Around Accelerator Services:

425 (a) Sourcing – Describe how innovators and companies will be sourced and any unique

426 processes the Respondent will utilize to identify the best technologies relevant to

427 BARDA’s mission/impact areas. It is expected that deal sourcing and technology

428 scouting will occur nationally and internationally. The Respondent must also

429 describe how mentors, experts, and business/commercialization consultants will be

430 sourced to support each company. If the Respondent currently does not have these

431 capabilities, describe how the Respondent will develop and maintain the

432 capabilities.

433 (b) Program Design and Execution – Describe how the Respondent aims to design

434 programming and services for companies at all levels of development across the

435 TRL scale. Outline any unique processes or components the Respondent will utilize

436 to ensure programmatic success to minimize technical and commercial risks and

437 maximize impact to companies in the programs.

438 (c) Wraparound and commercialization services – Outline the kind and scope of -

439 wraparound and commercialization services that the Respondent will provide.

440 Explain which of these services will be provided in-house and, if any, the relevant

441 partners that will be leveraged to provide other services.

442 (d) Outline a sample budget justification and timeline (including operational cost and

443 estimates of hourly costs for consultants/external partners) for the above Sourcing, 444 Program Design and Execution, and wraparound and commercialization services

445 including how many companies the Accelerator will support in a given fiscal year

446 given a proposed budget of $500k per year allocated for the Wrap Around

447 Accelerator Services. Complete the following for the budget justification:

448 1. Attachment 1 – BAN 2.0 Price Cost Workbook, tab ‘Annual Option – Wrap

449 Around’

450 2. Written narrative to include the following:

451 a. Timelines for the Wrap Around support (outlined in Section III) to

452 companies, based on proposed program design and projected number

453 of companies the Hub will support.

454 (e) Describe how the Respondent will provide market intelligence and strategic input

455 through market research and engagement with the entrepreneurial community to

456 help advance the USG and BARDA’s mission.

457 (f) Describe how the Respondent will define, track and report on BARDA mission-

458 related impact metrics.

459 b. Development, Evaluation, and Validation (DEV) Services:

460 (a) Describe how the Respondent will design a DEV funding program including a

461 description of the approach for sourcing, review, funding mechanisms, project

462 management, and validation services offered to companies under the option funding

463 assumption of ~$1 million per year for DEV services.

464 (b) Provide at least 3 Areas of Interest/focus areas based on BARDA’s strategic

465 priorities and gaps that the respondent would propose to BARDA for DEV funding

466 solicitation. For 2022-2026 BARDA strategic plan and examples of current Areas

467 of Interest/focus areas, please visit BARDA, BARDA BAA, and BARDA DRIVe

468 websites.

469 (c) Describe how the Respondent will provide technical assistance to companies as

470 required in Section III. The approach should empower innovators with core

471 competencies for business and clinical feasibility assistance to increase the

472 technology readiness level of their technology from concept to demonstration to

473 deployment. The Respondent should describe how their physical and virtual

474 environment/support mechanisms will support innovators at all stages to develop, 475 evaluate, validate, and commercialize their products.

476 c. For base funding assumption of $1 million per year for DEV services, complete the following

477 as a budget justification:

478 (a) Attachment 1 – BAN 2.0 Price Cost Workbook, tab ‘Annual Option – DEV ($1

479 million)’

480 (b) Written narrative to include the following:

481 1. Timelines for the DEV support (outlined in Section III) to companies

482 2. Number of funded projects

483 3. Types of projects the Accelerator hub will support annually.

484 4. Clearly demonstrate how the operational expenses were ascertained as a

485 factor of the 'Proposed Number of Subawards" (as entered in the cost/price

486 workbook) and how/if the operational expenses will fluctuate based on

487 volume of subawards and varying scope of subawards.

488 5. Any additional assumptions to support the details provided in the budget

489 justification

490 d. Provide a sample budget justification if BARDA provided additional funding of $10 million

491 in a particular fiscal year (under the $500 million program ceiling) subject to availability of

492 funds). Complete the following for the budget justification:

493 (a) Attachment 1 – BAN 2.0 Price Cost Workbook, tab ‘Annual Option – DEV ($10

494 million)’

495 (b) Written narrative to include the following:

496 1. Timelines for the DEV support (outlined in Section III) to companies

497 2. Number of funded projects

498 3. Types of projects the Accelerator Hub will support annually.

499 4. Clearly demonstrate how the operational expenses were ascertained as a

500 factor of the 'Proposed Number of Subawards" (as entered in the cost/price

501 workbook) and how/if the operational expenses will fluctuate based on

502 volume of subawards and varying scope of subawards.

503 5. Any additional assumptions to support the details provided in the budget

504 justification

506 5. Rapid Response Capability

507 a. In the event of a rapid response scenario, describe how the Respondent will scale and ramp

508 up Accelerator Hub functions to deliver rapid and scalable solutions in a scenario where

509 BARDA chooses to exercise the option of allocating up to $500 million (subject to availability

510 of funds) to provide rapid response support.

511 b. Provide a sample budget justification of how the Respondent can scale up support for both

512 Wrap Around Accelerator Support and DEV services in the event of an emergency. For the

513 justification assume that BARDA allocates $100 million (of the $500 million ceiling) and

514 requires the Accelerator Hub to support product DEV and wrap around accelerator support

515 services for up to 50 companies with milestone-driven funding. Complete the following for

516 the budget justification:

517 (a) Attachment 1 – BAN 2.0 Price Cost Workbook, tab ‘Rapid Response ($100

518 million)’

519 (b) Written narrative to include the following:

520 1. Timelines for the Rapid Response support (outlined in Section III) to

521 companies

522 2. Types of projects the Accelerator Hub will support

523 3. Clearly demonstrate how the operational expenses were ascertained as a

524 factor of the 'Proposed Number of Subawards" (as entered in the cost/price

525 workbook) and how/if the operational expenses will fluctuate based on

526 volume of subawards and varying scope of subawards.

527 4. Any additional assumptions to support the details provided in the budget

528 justification

530 c. Outline the Respondent’s organization, partners, and collaborators technical approach to

531 quickly pivot and accelerate the development and commercialization of products and to scale

532 up the facilities and expertise in a rapid response scenario such as addressing any public health

533 emergency needs.

534 d. If the Respondent has existing partnerships/infrastructure to support, list the partners within

535 the Respondent’s ecosystem and describe how and for which component they will support the

536 capabilities required of the Accelerator Hub. If no partnerships/infrastructure exists, outline

537 how the respondent aims to identify and partner with external partners.

539 6. Cost/Price Proposal

540 It is anticipated that the pricing structure for each Agreement will consist of a fixed price for (a)

541 Wraparound Accelerator services (approximately $500K annually), (b) a fixed price for Development, 542 Evaluation, and Validation services (approximately $1 million annually), and (c) a variably structured

543 Rapid Response Capability element that may be fixed price, expenditure based or any appropriate model

544 determined to be in the government’s best interest. The ceiling on the overall award, is up to $500 million

545 over the course of the agreement and would be largely determined by the needs of BARDA and availability

546 of funds. Additionally indicate and describe the proposed cost/resource sharing/proposed contributions, 547 which may consist of cash investment or in-kind contributions expressed in U.S. dollars. Greater resource

548 contributions will be considered favorably.

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

550 1. Written Cost/Price Proposal

551 2. Cost/Price Workbook

552 6.1 Written Cost/Price Proposal

553 The Written Cost/Price Proposal shall be provided in Word (.docx or .doc) or PDF and should detail all

554 the activities included in the proposed fixed price for each service separately as outlined in Section III and

555 Section VI (i.e., Wraparound Accelerator Services, Development, Evaluation, and Validation and Rapid

556 Response Capability). This narrative response should illustrate the Respondent’s understanding of the

557 labor market and the appropriate labor mix and costs associated with the services above. Note, the fixed

558 amounts for each service area in this section should support all requirements as outlined in Section III and

559 all other administrative activities. It should be inclusive of, but not necessarily limited to:

560 • Program Management Support

561 o Managing operational functions to meet and maintain the requirements of the proposed

562 programming

563 o Reporting requirements, meetings, and other deliverables as outlined in Appendix A

564 • Individual Projects under DEV Services & Rapid Response

565 o Sourcing, review, funding, and management of Individual Project Proposals as outlined

566 under Section III

567 o Project funding for funded company and validation services for relevant companies

568 o Wraparound support for funded projects

569 o Provide project management support and project and deliverable oversight to individual

570 projects support

571 6.2 Cost/Price Workbook

572 The Cost/Price Workbook shall be completed in the format provided in Attachment 1 – BAN 2.0 Price

573 Cost Workbook template. The Respondent should submit any supporting documentation separately as

574 necessary to supplement the cost/price workbook.

575 All proposal information in response to this solicitation is submitted at no cost or obligation to the

576 Government. Interested parties are responsible for adequately marking proprietary or competition-

577 sensitive information contained in their response.

580 XI. EVALUATION CRITERIA

581 Eligibility Requirements

582 The eligibility requirements will be reviewed against the minimum eligibility criteria defined in Section

583 V of this solicitation and as follows:

584 • Demonstrate a record of providing wraparound accelerator and commercialization services, and

585 product development, evaluation, and validation services.

586 • Have experience building a network of innovators, startups, investors, strategic partners, experts, 587 mentors, and other innovation ecosystem partners.

589 If it is determined that the Respondent does not satisfy the minimum eligibility requirements, the proposal

590 will not be evaluated. If it is determined the respondent does satisfy the minimum eligibility requirements, 591 the proposal will be evaluated against the evaluation criteria for each of the Required Capabilities (Wrap

592 Around Accelerator Services; DEV Services; Rapid Response Capability).

593 Proposal Evaluations

594 BARDA will review submissions and conduct proposal evaluations by technology area, on a rolling basis

595 as outlined in Section IX. The technology areas are as follows:

596 • Therapeutics/Vaccines

597 • Diagnostics/Medical Devices

598 • Digital Health

599 • Enabling Technologies (e.g., Biomanufacturing/Drug Development/Clinical Support)

600 • Special Populations (e.g., Pediatrics, Immunocompromised, Low Resource Settings)

601 If it is determined that the Respondent is responsive, the proposal will be evaluated against the following

602 evaluation criteria listed below in descending order of importance for each required capability:

603 (a) Summary of Relevant Experience

604 (b) Organization Capabilities and Key Personnel

605 (c) Program Design and Technical Approach

606 (d) Cost/Price Proposal

607 Summary of Relevant Experience

608 • Wrap Around Accelerator Services

609 o The proposal will be evaluated as to whether it demonstrates that their organization and

610 collaborators have the capability and prior experience of establishing and maintaining a

611 network of R&D capabilities and technical and commercialization support that is suitable

612 for accelerating health security innovations to market as well as experience in performing

613 the functions of a business Accelerator. The proposal will also be evaluated as to whether

614 it demonstrates experience in successfully identifying and transitioning R&D products

615 from early development to follow-on investment and eventual successful

616 commercialization.

617 • Development, Evaluation, and Validation Services

618 o The proposal should demonstrate that the Respondent’s organization and collaborators

619 have the capability and prior experience to source, review, fund, and manage multiple DEV

620 projects and to accelerate the process for innovators to increase the technical and business

621 capabilities of their venture, with…