BARDA Accelerator Network 2.0 - Solicitation (7.26.23).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 Page 1 of 27

I. BACKGROUND

The Biomedical Advanced Research and Development Authority (BARDA) within the Administration 1 for Strategic Preparedness and Response (ASPR) was established and mandated by Congress to catalyze 2 innovation in research and development (R&D), manufacturing, and procurement of Medical 3

Countermeasures (MCMs) against health security threats. MCMs are needed to prepare for and respond 4 to public health emergencies (PHEs) caused by chemical, biological, radiological, and nuclear (CBRN) 5 threats, pandemic influenza, and other emerging infectious diseases (e.g., COVID-19). The Division of 6

Research, Innovation, and Ventures (DRIVe) was established within BARDA to fund and accelerate the 7

R&D of breakthrough early-stage technologies for PHEs and support the innovation ecosystem and 8 reduce the risks associated with commercialization and regulation. In 2018, DRIVe launched the 9

BARDA Accelerator Network, a partnership with 13 accelerators across the country, to effectively 10 support early-stage innovations and the startups that are advancing them. The current BARDA 11

Accelerator Network has supported health security innovation ecosystem and medical countermeasures 12 development by: 13

• Cultivating a community of those advancing the commercialization of health security products, 14 technologies, and innovations. 15

• Identifying and fostering innovations in health security product and technology development. 16

• Providing wraparound services such as startup-focused curriculum, technical and business 17 mentorship, access to facilities and incubator spaces, and integration services to organizations 18 aligned with the BARDA’s mission 19

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

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

BAN 2.0 Solicitation Page 2 of 27

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 wraparound 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 already receiving 38

BARDA funding (“BARDA funded partners”1) by providing wraparound accelerator services 39 including entrepreneurship education and access to technical and business/commercialization 40 expertise and resources. 41

• Provide BARDA with capabilities to source, review, fund, and accelerate startups and perform 42 product development, evaluation, and validation of MCMs based on BARDA’s strategic priorities. 43

• Build a rapid emergency response infrastructure to fund and accelerate product development and 44 validation of MCMs that can be developed and deployed as quickly as possible in the event of a 45 public health emergency. 46

BARDA intends to enter into other transaction agreements with five or more Accelerator Hub 47 organizations with each Accelerator Hub providing resources and support focused on one of the following 48 technology areas: 49

• Therapeutics/Vaccines 50

• Diagnostics/Medical Devices 51

• Digital Health 52

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

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

Each Accelerator Hub can function individually or as a consortium of partners, although one legal entity 55 will need to be identified as the prime awardee for purposes of entering into an Agreement with BARDA. 56

It is anticipated that the Accelerator Hubs will provide funding and/or services to mission relevant 57 innovators and companies regardless of their physical location worldwide. Respondents may apply to 58 support more than one technology area, but each technology area response must be addressed in a separate 59

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

BAN 2.0 Solicitation Page 3 of 27 proposal. If a Respondent submits a separate proposal for each technology area, each proposal will be 60 assessed independently. 61

III. REQUIREMENTS 62

Program Management Requirements 63

BARDA’s role in BAN 2.0 will include providing funding, coordination of efforts, oversight, and 64 supporting opportunities for Accelerator Hubs to collaborate, and share expertise, knowledge, and events 65 across the innovation community. 66

The Accelerator Hub has the primary responsibility for designing and executing programming and services 67 as defined by BARDA in this section. Accelerator Hubs will be responsible for coordinating activities 68 approved under the award. The Accelerator Hub will be responsible for developing achievable program 69 plans, tracking all activities and processes, following the terms and conditions of the agreement, and 70 adhering to budget and approved reporting plans. The Accelerator Hubs will be responsible for planning 71 and participating collaboratively with BARDA under this agreement. Through participation in regular 72 teleconferences and/or face-to-face review meetings, the Accelerator Hub will work with BARDA to make 73 progress toward its goal of executing the Accelerator Hubs’ work plans. 74

The following is a summary of the general program requirements for Accelerator Hubs to manage a 75 prospective partnership with BARDA: 76

• Coordinate with BARDA on a regular basis to ensure alignment of the Accelerator Hub’s priorities 77 based on BARDA’s strategic priorities. 78

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

Requirements (Appendix A). 80

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

Program Operations Requirements 82

The requirements listed below are key components for services BARDA envisions of the Accelerator Hubs 83 as it pertains to Wraparound Accelerator Services, Development, Evaluation, and Validation Services, and 84

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

Hub will be required to provide resources and support to innovators and companies developing products 86 in one of the technology areas listed below (individual Hub focuses subject to change based on BARDA’s 87 priorities): 88

• Therapeutics/Vaccines 89

BAN 2.0 Solicitation Page 4 of 27 o Focus on next-generation therapeutic and vaccine platforms. 90

• Diagnostics/Medical Devices 91 o Focus on diagnostics and devices to enable pathogen-agnostic surveillance, detection, and 92 diagnosis, especially at point-of-care and at-home settings, and innovative medical devices 93 to improve the quality of casualty care, alert the potential of an adverse health condition, 94 simplify collection or processing of testing samples, and protect respiratory health. 95

• Digital Health 96 o Focus on development and application of digital health tools to empower people to prepare 97 for and respond to health security threats and improve the continuum of clinical care. 98

• Enabling Technologies (e.g., Biomanufacturing/Drug Development/Clinical Support) 99 o Focus on innovations in drug discovery and development, biomanufacturing innovations 100 to increase speed, capacity, portability, and scalability, and innovations to improve clinical 101 research and clinical care coordination. 102

• Special Populations (e.g., Pediatrics and/or Immunocompromised and/or Low Resource Settings) 103 o Focus on innovations that can improve the detection, diagnosis, treatment, and inform 104 outcomes in pediatric/neonatal populations and/or immunocompromised populations 105 and/or enable health equity solutions to traditionally underrepresented communities and 106 low-resource settings. Respondents can submit a proposal that focuses on all special 107 populations or a single population. 108

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

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

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

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

NIH Proof of Concept Network. In addition, there are several other external federal and private bench-to-114 market commercialization programs that may be leveraged, built on, and expanded to support the mission 115 of the Accelerator Hubs. 116

A. Wraparound Accelerator Services 117

BARDA supports innovators and companies with various levels of expertise at various stages of 118 development. Respondents are required to design programs and offer services across all technology 119 readiness levels (TRL). Under BARDA direction, the Accelerator Hub will be required to work with 120

BAN 2.0 Solicitation Page 5 of 27 innovators and companies in the ecosystem, including BARDA funded partners, to provide the following 121 services: 122

Outreach/Networking and Sourcing: 123

• Identify and refer promising domestic and foreign-based companies to address the specific needs 124 within BARDA’s mission. Each Accelerator hub will be expected to identify and refer 125 technologies on an ongoing basis and/or when requested by BARDA. 126

• Provide BARDA with key opinion leaders and expert panels within the specific technology area 127 on an ongoing basis and/or when requested. 128

• Promote BARDA funding opportunities and provide outreach and networking opportunities on an 129 ongoing basis and/or when requested by BARDA. 130

• Connect product developers and technology innovators including BARDA funded partners with a 131 network of life science and medical technology innovators, developers, collaborators, investors, 132 strategic partners, and other ecosystem partners. 133

• Provide market intelligence and strategic input to BARDA through market research and 134 engagement on an ongoing basis and/or when requested. 135

Entrepreneurship and Product Development Training and Education: 136

• Provide a diverse range of innovators interested in developing medical countermeasures access to 137 skills development, hands-on entrepreneurial experience, and networking opportunities. 138

• Provide entrepreneurial educational opportunities on medical countermeasure product 139 development and commercialization activities required to move technologies to the next stage 140 including topics such as business development, fundraising and financing, regulatory pathways, 141 and reimbursement. 142

• Recognize and prioritize common gaps and needs across the medical countermeasure product 143 development community and develop training and education programming to address the needs. 144

• Develop and deliver curriculum for support to innovators, startups, and innovation ecosystem via 145 workshops, webinars, other modes of training and communication. The Accelerator Hub must 146 ensure curriculum and workshops are inclusive and cater to diverse audiences including both US 147 and foreign-based innovators and startups that aim to develop their innovations for the US market. 148

Support for international innovators may include topics such as soft-landing support, IP 149 management, and identification of partnership and funding opportunities. 150

BAN 2.0 Solicitation Page 6 of 27

• Design and execute at least one health security-focused experiential, curriculum, and mentorship- 151 driven accelerator cohort or competition every two years, subject to exercise of relevant option(s). 152

These accelerator cohorts can be a complement of and/or be integrated with the Development, 153

Evaluation, and Validation Services requirement outlined below. 154

Wraparound and Commercialization Services: 155

• Build a network of mentors, industry experts, and key opinion leaders with technical and business 156 expertise that includes, but is not limited to, scientific/technical, manufacturing, quality assurance, 157 nonclinical, clinical, business development, regulatory, reimbursement, intellectual property, 158 legal, marketing, fundraising/financing, and strategic partnerships. 159

• Provide necessary expertise, advice and feedback to innovators and companies in the ecosystem, 160 including the BARDA funded partners, to accelerate technology and product development as well 161 as mitigate risks inherent to startup companies. 162

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

BARDA engagement and funding opportunities. 164

• Provide additional support to innovators including, but not limited to, 1:1 coaching/ mentoring 165 services, grant writing support, and boot camps/accelerator programs focused on specific 166 technology topics defined by BARDA. 167

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

Each Accelerator Hub will provide product DEV services to support innovators and companies that cover 170 a spectrum of technology readiness for its specific technology area of focus. These DEV services may be 171 provided through a combination of in-house efforts and/or collaborations with relevant experts/partners. 172

The general scope of effort for DEV services will include, but is not limited 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. Solicitations issued by an Accelerator 175

Hub could result in subawards structured similar to grants, contracts, prizes, challenges, 176 competitions, or other mechanisms as allowable under BARDA authorities. Subject to the exercise 177 of options for DEV services , each Accelerator Hub will be expected to run at least one funding 178 solicitation each year and support multiple projects with the potential to support additional projects 179 based on BARDA’s needs and the availability of additional funding. The number of projects 180 funded could change or be negotiated based on the funding and the scope of individual projects. 181

BAN 2.0 Solicitation Page 7 of 27

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

DEV services. The Accelerator Hubs are required to launch these projects within 2 months or less 183 from the receipt of project applications. However, BARDA might require that projects are funded 184 within days or weeks on a case-by-case basis, especially during emergency situations. 185

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

• Provide project management support to the funded projects – at a minimum, quarterly review 187 including progress assessed against established milestones. Accelerator Hubs are responsible for 188 coordinating with BARDA to make milestone-based go/no-go decisions. Accelerator Hubs may 189 terminate projects that fail to meet milestones and reallocate resources accordingly with input from 190

BARDA. 191

• Provide both technical and wraparound and commercialization support and access to experts and 192 mentors for the funded projects. 193

• Develop partnerships with industry and other stakeholders to facilitate the transition and 194 commercialization of innovations. 195

• Provide independent usability, feasibility, and validation testing services to funded DEV projects 196 that have successfully achieved their milestones and if requested by BARDA for additional 197

BARDA funded partners. These services would vary based on the technology readiness level of 198 the individual project and could include both preclinical and clinical validation. Accelerator Hubs 199 can build these capabilities in-house or can collaborate with partner(s) that can provide them. 200

C. Rapid Response Capability 202

The development of MCMs against health security threats is an ongoing process in anticipation of future 203 scenarios where BARDA must be able to act and deploy resources rapidly, such as in the event of a future 204

PHE. Once a rapid response scenario is identified by BARDA, it is imperative to dramatically accelerate 205 the development of appropriate MCMs. In addition to providing DEV and wraparound services during 206 times of “steady state”, BARDA expects the Accelerator Hubs to leverage additional resources, engage 207 external partners, and develop a streamlined plan for scaling Accelerator Hub operations and outputs in 208 any situation deemed necessary to require a rapid response from BARDA. 209

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

Accelerator Hub functions including wraparound accelerator services and DEV (outlined in Sections III.A 211 and III.B above) to deliver rapid and scalable solutions in the event of a rapid response scenario. During a 212 scenario, should BARDA choose to exercise the option of allocating significant additional funds (up to 213 the OTA agreement ceiling per Section VI) to the Accelerator Hub, the Hub needs to be able to boost its 214

BAN 2.0 Solicitation Page 8 of 27 capability to identify partners, deploy funds, and provide wraparound support for rapid and scaled-up 215 services (both with internal capabilities and relevant external partnerships) in accordance with the 216 proposed Rapid Response Capability Activation Plan (Appendix I). The Accelerator Hubs will be required 217 to effectively source, review, distribute, manage, and support multiple concurrent awards (potentially in 218 the 100s) to meet aggressive USG timelines, in as little as 5 calendar days (from requirement release to 219 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 240

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.

BAN 2.0 Solicitation Page 9 of 27

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. 249

Use of Funds Limitation 251

Accelerator Hubs are prohibited from using HHS funds obligated to an Agreement under this solicitation 252 to conduct investment activities including, but not limited to, taking equity positions in any entity 253 supported under the BAN 2.0 program. 254

It is important to note that this does not prohibit the Accelerator Hub from taking equity positions in any 255 of the supported entities, but rather limits the use of HHS funds for these activities. 256

Salary Rate Limitation 257

HHS is bound by applicable appropriations laws that direct that certain HHS funds cannot be used to pay 258 extramural salaries at a rate more than Executive Level II ($212,100 as of the fiscal year 2023). 259

Accordingly, USG funds appropriated to HHS and received by the Accelerator Hub cannot be used to pay 260 salaries more than the federal Executive Level II salary. 261

It is important to note that this does not limit the amount of salary an Accelerator Hub may compensate an 262 individual, rather it limits the amount of salary that can be paid to an individual using HHS funds. 263

Accounting System 264

The respondent must demonstrate the ability to maintain an accounting system that is capable of tracking 265 the expenditures of USG funds and investments of those funds given the financial requirements of this 266 partnership. 267

V. ELIGIBILITY CRITERIA 268

BAN 2.0 Solicitation Page 10 of 27

All responsible sources capable of satisfying the U.S. Government’s needs may submit a proposal that will 269 be considered by BARDA. Respondents may include single entity or a consortium of partners. To be 270 eligible for evaluation, the respondent (either individual entity or a consortium of partners) must, at a 271 minimum: 272

• Demonstrate a record of providing wraparound accelerator and commercialization services, and 273 product development, evaluation, and validation services. 274

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

Respondents may submit more than one proposal, provided that each proposal is to support a hub for one 277 specific technology area (Therapeutics/Vaccines, Diagnostics/Medical Devices, Enabling Technologies, 278

Digital Health, or Special Populations. Each proposal should focus on one specific technology area Hub. 279

Multiple proposals by the same respondent, each proposing a different specific technology area but using 280 shared core facilities and programs are acceptable and will be reviewed independently. 281

BARDA will not accept duplicate or highly overlapping proposals. 282

VI. AWARD INFORMATION – INTENT TO EXECUTE MULTIPLE 283

AGREEMENTS 284

BARDA intends to make at least one award per technology area (outlined in Section II), however, reserves 285 the right to add additional technology areas or fund multiple Accelerator Hubs in a single technology area 286 based on changing BARDA priorities. BARDA reserves the right to reopen the solicitation to call for 287 additional submissions. 288

Period of Performance 289

BARDA anticipates executing multiple awards (“Agreements”) from this solicitation to Respondents with 290 each Agreement expected to result in a two-year base period with additional option periods up to 10 years, 291 to be exercised at BARDA’s discretion and subject to availability of funds. It is BARDA’s intent to enter 292 into five or more Agreements (at least one for each technology area) that would be executed through 293

BARDA’s “Other Transaction” authority. 294

Anticipated Funding 295

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

Agreement will be $1.5 million. The base funding will be used by the respondent to provide program 297 management services, wraparound accelerator, DEV services, and project management costs as outlined 298

BAN 2.0 Solicitation Page 11 of 27 in Section III. In addition, BARDA’s intention is to structure an agreement which contains annual funding 299 options for continuing wraparound and DEV services in the aggregate amount of $1.5 million. 300

Additionally, agreements will be structured to be able to exercise annual or other options at higher 301 amounts. Each Agreement is anticipated to include a ceiling of $500 million over the period of the 302

Agreement. BARDA may provide funds for additional wraparound and product DEV services beyond the 303 base amount up to the negotiated ceiling amounts as established in the Agreement based on BARDA’s 304 priorities and needs and in the event of a rapid response situation including, but not limited to, a future 305 pandemic or public health emergency. 306

Respondents are encouraged to propose cost/resource sharing/ contributions, which may consist of cash 307 investment or in-kind contributions expressed in U.S. dollars. Greater cost/resource contributions will be 308 considered favorably. 309

VII. ACCESS TO RECORDS & FOREIGN OWNED INTERESTS 310

Access to Records 311

The USG, at its discretion, will have access to and the right to examine records of the Respondents per 312 normal course of the Other Transaction Agreement. BARDA may periodically request information from 313 the Accelerator Hubs, including information on subawardees and recipients of services funded by this 314

OTA, on technology, financial, and intellectual property (IP) progress to track impact, performance, and 315 progress, and to overcome roadblocks towards accomplishing its mission. 316

Foreign-Owned Interests 317

The Respondent shall ensure that no foreign investment capital or interests from USG prohibited sources 318 list of Embargoed and Sanctioned countries3, as defined by U.S. Departments of Treasury and Commerce, 319 are utilized by the Respondent. 320

VIII. RIGHTS RESERVED DURING THE SOLICITATION PROCESS 321

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

• The right to request additional, necessary documentation upon initial review. Such additional 323 information may include but is not limited to, a further detailed proposal, budgets, and 324 representations and certifications. 325

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

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

BAN 2.0 Solicitation Page 12 of 27

• The right to remove a Respondent from consideration should (i) the Respondent fails to reach an 327 agreement on terms, conditions, and cost within a reasonable time; (ii) the Respondent fails to 328 provide requested additional information in a timely manner, or (iii) BARDA believes it is in the 329 best interests of the USG. 330

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

IX. SUBMISSION OVERVIEW & INSTRUCTIONS 332

All interested parties are requested to 1) submit all solicitation related questions and 2) notify BARDA 333 of their intent to respond to this solicitation via email by at least 15 days prior to the respective Hub 334 response deadline below to BAN_Inquiries@hhs.gov. In the email, the Respondent must include 335 information on their organization including: 1) three to five examples of relevant experience performing 336 the services as outlined under Section III, specifically Wraparound Accelerator Services, DEV Services, 337 and Rapid Response Capability services, 2) potential partners and collaborators, and 3) the technology 338 area(s) to which they intend to apply. 339

Submissions are due at 12:00PM ET on the due dates listed below for each technology area. BARDA 340 may adjust the closing date for submissions under any of the following technology areas through 341 amendment of this notice. 342

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

120 days of the proposal due date. 344

• Therapeutics/Vaccines on October 2, 2023, with the intent to make an award within 90-120 days 345 of the proposal due date. 346

• Enabling Technologies on October 2, 2023, with the intent to make an award within 90-120 days 347 of the proposal due date. 348

• Digital Health on January 12, 2024, with the intent to make an award within 90-120 days of the 349 proposal due date. 350

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

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

All proposals will be kept confidential and reviewed pursuant to the criteria established. Any interested 353 parties that respond to this solicitation will be deemed a Respondent. BARDA reserves the right to engage 354 with any Respondent, as necessary, to clarify information submitted in the proposal. Respondents not 355 selected for the award will be notified of the decision, but formal debriefings will not be offered. 356 mailto:BAN_Inquiries@hhs.gov

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

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

FAQ 359

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

X. PROPOSAL PREPARATION 361

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

Government. 363

Please submit a proposal consisting of a narrative (including figures, schematics, diagrams, graphics, etc., 364 which must be labeled) that describes the organization’s capabilities, experience, and approach, to perform 365 the tasks and responsibilities outlined in sections 1 – 5 below. Please structure proposals in accordance 366 with the sections below. 367

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

Identify the technology area the Respondent (single entity or a consortium of partners) is applying for and 369 describe 370

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

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

• Why the Respondent is interested in partnering with BARDA, 373

• How the Respondent can help BARDA’s mission to save lives and protect Americans from 21st 374 century health security threats as a BAN 2.0 Accelerator Hub, and 375

• Summary of the qualitative and quantitative metrics and outcomes that the respondent aims to 376 achieve over the period of the Agreement 377

2. Summary of Relevant Experience 378

This section pertains to current and past performance. The Respondent (single entity or a consortium of 379 partners) must include detailed examples of its relevant current and past performance. The Respondent 380 should also include experience and past performance of the organization, key personnel and collaborators 381 who will deliver the objectives of the partnership. All examples should stand on their own without the 382 need for evaluators to do any external research outside of what is provided in the proposal. Proper citations 383

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

a. Experience delivering on the requirements outlines in Section III above 385

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(a) Wraparound Accelerator services 386

1. Outreach/Networking and Sourcing 387

2. Entrepreneurship and Product Development Education/Training 388

3. Wraparound and Commercialization Services 389

(b) DEV Services 390

(c) Rapid Response Capability 391

b. Experience in successfully identifying and transitioning R&D products from early 392 development to follow-on investment and eventual successful commercialization. 393

c. Experience supporting product development and commercialization with the intent to generate 394 a measurable scientific or social impact that has addressed an unmet need in the life sciences 395 and/or health security landscape. 396

d. Experience managing operational functions to meet and maintain requirements of the 397 proposed programming. 398

3. Organization Capabilities and Key Personnel 400

Respondent (single entity or consortium of partners) should provide an overview of the capabilities it 401 possesses to source innovators and companies, provide Wraparound Accelerator services, DEV, and Rapid 402

Response services as described in Section III in support of both national and international companies 403 aligned with BARDA’s mission. If the Respondent does not currently have all the necessary capabilities, 404 describe how the Respondent plans to scale operations to support Accelerator Hub activities and 405 management. 406

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

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

(a) Name 410

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

(c) Relevant Experience 412

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

b. Provide a detailed description of how the Respondent will avoid conflicts of interest, if the 414 potential for any exists. It is the Respondent’s responsibility to establish policies and manage 415 all internal conflicts of interest. 416

c. Provide a description of the Respondent’s existing facilities and infrastructure and any future 417 plans, if any, for scale-up to address this partnership. 418

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

4. Program Design and Technical Approach 420

Respondents (single entity or consortium of partners) should provide an overview of how they envision to 421 support the following required capabilities of the BARDA Accelerator Network Hub as identified in 422

Section III: 423

a. Wrap Around Accelerator Services: 424

(a) Sourcing – Describe how innovators and companies will be sourced and any unique 425 processes the Respondent will utilize to identify the best technologies relevant to 426

BARDA’s mission/impact areas. It is expected that deal sourcing and technology 427 scouting will occur nationally and internationally. The Respondent must also 428 describe how mentors, experts, and business/commercialization consultants will be 429 sourced to support each company. If the Respondent currently does not have these 430 capabilities, describe how the Respondent will develop and maintain the 431 capabilities. 432

(b) Program Design and Execution – Describe how the Respondent aims to design 433 programming and services for companies at all levels of development across the 434

TRL scale. Outline any unique processes or components the Respondent will utilize 435 to ensure programmatic success to minimize technical and commercial risks and 436 maximize impact to companies in the programs. 437

(c) Wraparound and commercialization services – Outline the kind and scope of -438 wraparound and commercialization services that the Respondent will provide. 439

Explain which of these services will be provided in-house and, if any, the relevant 440 partners that will be leveraged to provide other services. 441

(d) Outline a sample budget justification and timeline (including operational cost and 442 estimates of hourly costs for consultants/external partners) for the above Sourcing, 443

Program Design and Execution, and wraparound and commercialization services 444 including how many companies the Accelerator will support in a given fiscal year 445 given a proposed budget of $500k per year allocated for the Wrap Around 446

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

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

Around’ 449

2. Written narrative to include the following: 450

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a. Timelines for the Wrap Around support (outlined in Section III) to 451 companies, based on proposed program design and projected number 452 of companies the Hub will support. 453

(e) Describe how the Respondent will provide market intelligence and strategic input 454 through market research and engagement with the entrepreneurial community to 455 help advance the USG and BARDA’s mission. 456

(f) Describe how the Respondent will define, track and report on BARDA mission-457 related impact metrics. 458

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

(a) Describe how the Respondent will design a DEV funding program including a 460 description of the approach for sourcing, review, funding mechanisms, project 461 management, and validation services offered to companies under the option funding 462 assumption of ~$1 million per year for DEV services. 463

(b) Provide at least 3 Areas of Interest/focus areas based on BARDA’s strategic 464 priorities and gaps that the respondent would propose to BARDA for DEV funding 465 solicitation. For 2022-2026 BARDA strategic plan and examples of current Areas 466 of Interest/focus areas, please visit BARDA, BARDA BAA, and BARDA DRIVe 467 websites. 468

(c) Describe how the Respondent will provide technical assistance to companies as 469 required in Section III. The approach should empower innovators with core 470 competencies for business and clinical feasibility assistance to increase the 471 technology readiness level of their technology from concept to demonstration to 472 deployment. The Respondent should describe how their physical and virtual 473 environment/support mechanisms will support innovators at all stages to develop, 474 evaluate, validate, and commercialize their products. 475

c. For base funding assumption of $1 million per year for DEV services, complete the following 476 as a budget justification: 477

(a) Attachment 1 – BAN 2.0 Price Cost Workbook, tab ‘Annual Option – DEV ($1 478 million)’ 479

(b) Written narrative to include the following: 480

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

2. Number of funded projects 482

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

BAN 2.0 Solicitation Page 17 of 27

4. Clearly demonstrate how the operational expenses were ascertained as a 484 factor of the 'Proposed Number of Subawards" (as entered in the cost/price 485 workbook) and how/if the operational expenses will fluctuate based on 486 volume of subawards and varying scope of subawards. 487

5. Any additional assumptions to support the details provided in the budget 488 justification 489

d. Provide a sample budget justification if BARDA provided additional funding of $10 million 490 in a particular fiscal year (under the $500 million program ceiling) subject to availability of 491 funds). Complete the following for the budget justification: 492

(a) Attachment 1 – BAN 2.0 Price Cost Workbook, tab ‘Annual Option – DEV ($10 493 million)’ 494

(b) Written narrative to include the following: 495

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

2. Number of funded projects 497

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

4. Clearly demonstrate how the operational expenses were ascertained as a 499 factor of the 'Proposed Number of Subawards" (as entered in the cost/price 500 workbook) and how/if the operational expenses will fluctuate based on 501 volume of subawards and varying scope of subawards. 502

5. Any additional assumptions to support the details provided in the budget 503 justification 504

5. Rapid Response Capability 506

a. In the event of a rapid response scenario, describe how the Respondent will scale and ramp 507 up Accelerator Hub functions to deliver rapid and scalable solutions in a scenario where 508

BARDA chooses to exercise the option of allocating up to $500 million (subject to availability 509 of funds) to provide rapid response support. 510

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

Wrap Around Accelerator Support and DEV services in the event of an emergency. For the 512 justification assume that BARDA allocates $100 million (of the $500 million ceiling) and 513 requires the Accelerator Hub to support product DEV and wrap around accelerator support 514 services for up to 50 companies with milestone-driven funding. Complete the following for 515 the budget justification: 516

BAN 2.0 Solicitation Page 18 of 27

(a) Attachment 1 – BAN 2.0 Price Cost Workbook, tab ‘Rapid Response ($100 517 million)’ 518

(b) Written narrative to include the following: 519

1. Timelines for the Rapid Response support (outlined in Section III) to 520 companies 521

2. Types of projects the Accelerator Hub will support 522

3. Clearly demonstrate how the operational expenses were ascertained as a 523 factor of the 'Proposed Number of Subawards" (as entered in the cost/price 524 workbook) and how/if the operational expenses will fluctuate based on 525 volume of subawards and varying scope of subawards. 526

4. Any additional assumptions to support the details provided in the budget 527 justification 528

c. Outline the Respondent’s organization, partners, and collaborators technical approach to 530 quickly pivot and accelerate the development and commercialization of products and to scale 531 up the facilities and expertise in a rapid response scenario such as addressing any public health 532 emergency needs. 533

d. If the Respondent has existing partnerships/infrastructure to support, list the partners within 534 the Respondent’s ecosystem and describe how and for which component they will support the 535 capabilities required of the Accelerator Hub. If no partnerships/infrastructure exists, outline 536 how the respondent aims to identify and partner with external partners. 537

6. Cost/Price Proposal 539

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

Wraparound Accelerator services (approximately $500K annually), (b) a fixed price for Development, 541

Evaluation, and Validation services (approximately $1 million annually), and (c) a variably structured 542

Rapid Response Capability element that may be fixed price, expenditure based or any appropriate model 543 determined to be in the government’s best interest. The ceiling on the overall award, is up to $500 million 544 over the course of the agreement and would be largely determined by the needs of BARDA and availability 545 of funds. Additionally indicate and describe the proposed cost/resource sharing/proposed contributions, 546 which may consist of cash investment or in-kind contributions expressed in U.S. dollars. Greater resource 547 contributions will be considered favorably. 548

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

BAN 2.0 Solicitation Page 19 of 27

1. Written Cost/Price Proposal 550

2. Cost/Price Workbook 551

6.1 Written Cost/Price Proposal 552

The Written Cost/Price Proposal shall be provided in Word (.docx or .doc) or PDF and should detail all 553 the activities included in the proposed fixed price for each service separately as outlined in Section III and 554

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

Response Capability). This narrative response should illustrate the Respondent’s understanding of the 556 labor market and the appropriate labor mix and costs associated with the services above. Note, the fixed 557 amounts for each service area in this section should support all requirements as outlined in Section III and 558 all other administrative activities. It should be inclusive of, but not necessarily limited to: 559

• Program Management Support 560 o Managing operational functions to meet and maintain the requirements of the proposed 561 programming 562 o Reporting requirements, meetings, and other deliverables as outlined in Appendix A 563

• Individual Projects under DEV Services & Rapid Response 564 o Sourcing, review, funding, and management of Individual Project Proposals as outlined 565 under Section III 566 o Project funding for funded company and validation services for relevant companies 567 o Wraparound support for funded projects 568 o Provide project management support and project and deliverable oversight to individual 569 projects support 570

6.2 Cost/Price Workbook 571

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

Cost Workbook template. The Respondent should submit any supporting documentation separately as 573 necessary to supplement the cost/price workbook. 574

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

Government. Interested parties are responsible for adequately marking proprietary or competition-576 sensitive information contained in their response. 577

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XI. EVALUATION CRITERIA 580

Eligibility Requirements 581

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

V of this solicitation and as follows: 583

• Demonstrate a record of providing wraparound accelerator and commercialization services, and 584 product development, evaluation, and validation services. 585

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

If it is determined that the Respondent does not satisfy the minimum eligibility requirements, the proposal 589 will not be evaluated. If it is determined the respondent does satisfy the minimum eligibility requirements, 590 the proposal will be evaluated against the evaluation criteria for each of the Required Capabilities (Wrap 591

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

Proposal Evaluations 593

BARDA will review submissions and conduct proposal evaluations by technology area, on a rolling basis 594 as outlined in Section IX. The technology areas are as follows: 595

• Therapeutics/Vaccines 596

• Diagnostics/Medical Devices 597

• Digital Health 598

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

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

If it is determined that the Respondent is responsive, the proposal will be evaluated against the following 601 evaluation criteria listed below in descending order of importance for each required capability: 602

(a) Summary of Relevant Experience 603

(b) Organization Capabilities and Key Personnel 604

(c) Program Design and Technical Approach 605

(d) Cost/Price Proposal 606

Summary of Relevant Experience 607

• Wrap Around Accelerator Services 608

BAN 2.0 Solicitation Page 21 of 27 o The proposal will be…