BAN 2.0 Diagnostics, Medical Devices Hub - Solicitation.pdf

FOUO – Source Selection Sensitive

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

Network 2.0: Supplemental Announcement to Fill Diagnostics and Medical Devices Hub Vacancy

March 5, 2026

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. MINIMUM ELIGIBILITY CRITERIA

VI. AWARD INFORMATION

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

X. PROPOSAL PREPARATION

TECHNICAL PROPOSAL…………………………………………………………………...….11

COST PROPOSAL ...........………………………………………………………………………12

PAGE LIMIT ....…………………………………………………………………………………12

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 reduce 8 the risks associated with commercialization and regulation. In 2018, DRIVe launched the BARDA 9

Accelerator Network (BAN), a partnership with 13 accelerators across the country, to effectively support 10 early-stage innovations and the startups that are advancing them. Building on the success of the first 11 model, in 2024, BARDA launched the next generation of the BARDA Accelerator Network (BAN 2.0)1, 12 which emphasizes a technology-focused approach to acceleration and offers non-dilutive funding for 13 proof-of-concept-stage product development. The goal of the 5-hub network (Diagnostics/Medical 14

Devices Hub, Digital Health Hub, Enabling Technologies Hub, Special Populations Hub, and 15

Therapeutics/Vaccines Hub) is to support the entrepreneurship ecosystem with commercialization 16 resources and product development funding. Each hub sources innovative early-stage ideas in its 17 respective technology/focus areas and provides funding to assess the feasibility of technology concepts 18 and support product development and validation, building a robust pipeline for future BARDA partnership 19 opportunities. In addition, the network serves as an agile and scalable infrastructure to accelerate the 20 development and validation of medical countermeasures that can be developed and deployed as quickly 21 as possible in the event of a public health emergency. BARDA currently has partnerships with accelerators 22 to support four of the five hubs and is now seeking a partner to serve as the Diagnostics/Medical Devices 23

Hub, with those duties scheduled to begin on or before September 30, 2026. 24

II. OBJECTIVES 25

BARDA is seeking a partner (“Accelerator Hub”) to serve as the BARDA Accelerator Network 26

Diagnostics/Medical Devices Hub, using BARDA’s Other Transaction authority, to foster the growth of 27 the health security innovation ecosystem with commercialization and wraparound support, and to enable 28 rapid development, evaluation, and validation of medical countermeasures. Similar to the current BAN 29

Hubs, the Diagnostics/Medical Devices Hub will support BARDA’s mission by addressing the following 30

1 To learn more about the current BARDA Accelerator Network, visit https://drive.hhs.gov/accelerators.html https://drive.hhs.gov/accelerators.html

BAN 2.0 Solicitation Page 2 of 27 objectives/tasks, with a focus on innovators and companies that fit within the diagnostics/medical devices 31 space: 32

• Provide wraparound acceleration services, including entrepreneurship education and access to 33 business/commercialization and technical expertise and resources, to BARDA-aligned innovators 34 and companies developing health security solutions. 35

• Provide BARDA with capabilities to source, review, fund, and accelerate innovators and companies 36 and perform product development, evaluation, and validation of MCMs based on BARDA’s 37 strategic priorities. 38

• Build a rapid emergency response infrastructure to fund and accelerate product development and 39 validation of MCMs that can be developed and deployed as quickly as possible in the event of a 40 public health emergency. 41

BARDA intends to enter into an Other Transaction Agreement with an organization to provide resources 42 and support for the Diagnostics/Medical Devices focus area: 43

• Diagnostics/ Medical Devices 44 o Focus on diagnostics and devices to enable pathogen-agnostic surveillance, detection, and 45 diagnosis, especially at point-of-care and at-home settings, and innovative medical devices 46 to improve the quality of casualty care, alert to the potential of an adverse health condition, 47 simplify the collection or processing of testing samples, and protect respiratory health 48

The Accelerator Hub can operate independently or as a consortium of partners, though one legal entity 49 must be identified as the prime awardee to enter into an agreement with BARDA. It is anticipated that the 50

Accelerator Hub will provide funding and/or services to mission-relevant innovators nationally, regardless 51 of the Hub’s physical location. 52

III. REQUIREMENTS 53

Program Management Requirements 54

BARDA’s role in BAN 2.0 includes providing funding, coordination of efforts, oversight, and supporting 55 opportunities for Accelerator Hubs to collaborate and share expertise, knowledge, and events across the 56 innovation community. 57

The Accelerator Hub has the primary responsibility for designing and executing programming and services 58 as defined by BARDA in this section. The Accelerator Hub will be responsible for coordinating activities 59 approved under the award. The Accelerator Hub will be responsible for developing achievable program 60

BAN 2.0 Solicitation Page 3 of 27 plans, tracking all activities and processes, following the terms and conditions of the agreement, and 61 adhering to the budget and approved reporting plans. The Accelerator Hub will be responsible for planning 62 and participating collaboratively with BARDA under the larger BAN 2.0 agreement. Through participation 63 in regular teleconferences and/or face-to-face review meetings, the Accelerator Hub will work with 64

BARDA to make progress toward its goal of executing the Accelerator Hub’s work plans. 65

The following is a summary of the general program requirements for an Accelerator Hub to manage a 66 prospective partnership with BARDA: 67

• Coordinate with BARDA regularly to ensure alignment of the Accelerator Hub’s priorities based 68 on BARDA’s strategic priorities. 69

• Submit technical reports and deliverables, consistent with the Deliverables and Reporting 70

Requirements (Appendix A). 71

• Maintain fiscal and programmatic systems to document accountability and performance. 72

Program Operations Requirements 73

The Respondents must demonstrate the capability to provide Wraparound Accelerator Services, 74

Development, Evaluation, and Validation (DEV) Services, and Rapid Response Capability services as 75 detailed below. Competitive proposals may demonstrate advancement of or having complemented 76 previous and existing HHS programs such as the current BARDA Accelerator Network, CARB-X, NIH 77

Point-of-Care Technologies Research Network (POCTRN), NIH Rapid Acceleration of Diagnostics 78

(RADx), and the NIH Proof of Concept Network. In addition, there are several other external federal and 79 private bench-to-market commercialization programs that may be leveraged, built on, and expanded to 80 support the mission of this Accelerator Hub. 81

A. Wraparound Accelerator Services 82

BARDA supports innovators and companies with various levels of expertise at various stages of 83 development. Respondents are required to design programs and offer services across all technology 84 readiness levels (TRL). Under BARDA direction, the Accelerator Hub will be required to work with 85 innovators and companies in the ecosystem to provide the following services: 86

Outreach/Networking and Sourcing: 87

• Identify and refer promising innovators and companies to address the specific needs within 88

BARDA’s mission. The Accelerator Hub will be expected to identify and refer technologies on 89 an ongoing basis and/or when requested by BARDA. 90

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• Provide BARDA with key opinion leaders and expert panels within the specific technology area 91

(diagnostics/medical devices) on an ongoing basis and/or when requested. 92

• Promote BARDA funding opportunities and provide outreach and networking opportunities on an 93 ongoing basis and/or when requested by BARDA. 94

• Connect product developers and technology innovators, including with a network of life science 95 and medical technology innovators, developers, collaborators, investors, strategic partners, and 96 other ecosystem partners. 97

• Provide market intelligence and strategic input to BARDA through market research and 98 engagement on an ongoing basis and/or when requested. 99

Entrepreneurship and Product Development Training and Education: 100

• Provide a diverse range of innovators interested in developing medical countermeasures access to 101 skills development, hands-on entrepreneurial experience, and networking opportunities. 102

• Provide entrepreneurial educational opportunities on medical countermeasure product 103 development and commercialization activities required to move technologies to the next stage, 104 including topics such as business development, fundraising and financing, regulatory pathways, 105 and reimbursement. 106

• Recognize and prioritize common gaps and needs across the medical countermeasure product 107 development community and develop training and education programming to address the needs. 108

• Develop and deliver curriculum for support to innovators, startups, and the innovation ecosystem 109 via workshops, webinars, and other modes of training and communication. 110

• Design and execute at least one health security-focused experiential, curriculum, and mentorship-111 driven accelerator cohort or competition every year, subject to the exercise of relevant option(s). 112

Wraparound and Commercialization Services: 113

• Build a network of mentors, industry experts, and key opinion leaders with technical and business 114 expertise that includes, but is not limited to, scientific/technical, manufacturing, quality assurance, 115 nonclinical, clinical, business development, regulatory, reimbursement, intellectual property, 116 legal, marketing, fundraising/financing, and strategic partnerships. 117

• Provide necessary expertise, advice, and feedback to innovators and companies in the ecosystem 118 to accelerate technology and product development as well as mitigate risks inherent to early-stage 119 development. 120

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• Make connections to investors, corporate and strategic partners, and incubators, in addition to 121

BARDA engagement and funding opportunities. 122

• Provide additional support to innovators, including, but not limited to, 1:1 coaching/mentoring 123 services, grant writing support, and boot camps/accelerator programs focused on specific 124 technology topics defined by BARDA. 125

B. Development, Evaluation, and Validation (DEV) Services 127

The Accelerator Hub will provide product DEV services to support innovators and companies that cover 128 a spectrum of technology readiness for its specific technology area of focus. These DEV services may be 129 provided through a combination of in-house efforts and/or collaborations with relevant experts/partners. 130

The general scope of effort for DEV services will include, but is not limited to: 131

• In collaboration with BARDA, identify unmet needs in the BARDA portfolio. Develop, run, and 132 manage funding solicitation topics to address the needs. Solicitations issued by an Accelerator 133

Hub could result in subawards structured similar to grants, contracts, prizes, challenges, 134 competitions, or other mechanisms as allowable under BARDA authorities. Subject to the exercise 135 of options for DEV services, each Accelerator Hub will be expected to run at least one funding 136 solicitation each year (“annual solicitation”) and support multiple projects, with the potential to 137 support additional projects based on BARDA’s needs and the availability of additional funding. 138

Those projects awarded against the annual solicitation are anticipated to be structured akin to 139 contracts that are milestone-driven and require Accelerator Hub project management throughout 140 the sub-award project lifecycle. The number of projects funded could change or be negotiated 141 based on the funding and the scope of individual projects. 142

• For each project, the Accelerator Hub is required to source, review, award, and manage product 143

DEV services. The Accelerator Hub may be required to launch these projects on an accelerated 144 timeline, including in a matter of weeks or evens days during emergency situations. 145

• Distribute, manage, and support multiple concurrent individual DEV project awards. 146

• Provide project management support to the funded projects – at a minimum, provide reviews, e.g., 147 monthly, bi-monthly, quarterly, etc., depending on the individual project timeline, to assess 148 progress against established milestones. Accelerator Hubs are responsible for coordinating with 149

BARDA to make milestone-based go/no-go decisions. Accelerator Hubs may terminate projects 150 that fail to meet milestones and reallocate resources accordingly, with input from BARDA. 151

• Provide both technical, wraparound, and commercialization support and access to experts and 152 mentors for the funded projects. 153

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• Develop partnerships with industry and other stakeholders to facilitate the transition and 154 commercialization of innovations. 155

• Facilitate independent usability, feasibility, and validation testing services for funded DEV 156 projects, and potentially other BARDA-funded partners, that have successfully achieved their 157 milestones. These services would vary based on the technology readiness level of the individual 158 project and could include both preclinical and clinical validation. 159

C. Rapid Response Capability 160

The development of MCMs against health security threats is an ongoing process in anticipation of future 161 scenarios where BARDA must be able to act and deploy resources rapidly, such as in the event of a future 162

PHE. Once a rapid response scenario is identified by BARDA, it is imperative to dramatically accelerate 163 the development of appropriate MCMs. In addition to providing DEV and wraparound services during 164 times of “steady state”, BARDA expects the Accelerator Hubs to leverage additional resources, engage 165 external partners, and develop a streamlined plan for scaling Accelerator Hub operations and outputs in 166 any situation deemed necessary to require a rapid response from BARDA. 167

The Accelerator Hub will be required to demonstrate the know-how and capability to ramp up all 168

Accelerator Hub functions, including wraparound accelerator services and DEV (outlined in Sections III.A 169 and III.B above), to deliver rapid and scalable solutions in the event of a rapid response scenario. During 170 a scenario, should BARDA choose to exercise the option of allocating significant additional funds (up to 171 the OTA agreement ceiling per Section VI) to the Accelerator Hub, the Hub needs to be able to boost its 172 capability to identify partners, deploy funds, and provide wraparound support for rapid and scaled-up 173 services (both with internal capabilities and relevant external partnerships) in accordance with the 174 proposed Rapid Response Capability Activation Plan (Appendix A). The Accelerator Hubs will be 175 required to effectively source, review, distribute, manage, and support multiple concurrent awards 176

(potentially up to 50+) to meet aggressive USG timelines, in as little as 5 calendar days (from requirement 177 release to award) during a rapid response event. 178

IV. OTHER REQUIREMENTS 179

Avoiding Organizational Conflicts of Interest (OCI) 180

Respondents must disclose whether any members of the proposed team for the project (including any 181 subcontractors or consultants), including their individual team members and proposed subcontractors or 182 consultants, have provided similar support to any U.S. Government agency or are currently providing 183

BAN 2.0 Solicitation Page 7 of 27 professional consulting services2 to any part of the USG. Respondents must also disclose and certify if 184 any individual member of their proposed team has provided professional consulting services previously 185 to ASPR/BARDA within the previous three years from the date of the release of this solicitation. A 186 determination will then be made in BARDA’s best business judgment as to whether a respondent has a 187 conflict of interest and whether an appropriate mitigation plan is feasible. If this relationship is 188 determined to create a conflict of interest that cannot be mitigated, then the individual or entity will be 189 ineligible to be a part of the proposal. Current or former BARDA personnel (federal employees, fellows, 190 or support contractors) who worked for BARDA on the subject program within the previous year or at 191 the time of the proposal submission are ineligible to respond. In addition, any individual who contributed 192 to the creation of this announcement is ineligible to respond. 193

As part of the proposal submission, all members of the proposed team (including any potential 194 subcontractors or consultants) must affirm whether their organizations and/or individual team members 195 have provided any professional consulting services in support of any USG agency in the past three years. 196

This includes a former BARDA employee or a member who has provided Accelerator Network support 197 to BARDA or another U.S. Government agency with whom BARDA engages. It is the responsibility of 198 the Respondent to disclose this information and demonstrate that no actual or potential conflict of 199 interest exists. Adequate information about the services rendered must be provided to allow BARDA to 200 make this determination. 201

If professional consulting services are currently, or have been, provided to any USG program(s) by a 202 member of a proposed team, the proposal must include the following: 203

a) The name of the USG program office receiving the support 204

b) The contract, grant, agreement, etc., number 205

c) Identification of proposed team member(s) (e.g., sub-awardee, consultant) providing the support 206

d) A comprehensive OCI mitigation plan. 207

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 8 of 27

Use of Funds Limitation 209

Accelerator Hubs are prohibited from using HHS funds obligated to an Agreement under this solicitation 210 to conduct investment activities, including, but not limited to, taking equity positions in any entity 211 supported under the BAN 2.0 program. 212

It is important to note that this does not prohibit the Accelerator Hub from taking equity positions in any 213 of the supported entities, but rather limits the use of HHS funds for these activities. 214

Salary Rate Limitation 215

HHS is bound by applicable appropriations laws that direct that certain HHS funds cannot be used to pay 216 extramural salaries at a rate more than Executive Level II ($228,100 as of the fiscal year 2026). 217

Accordingly, USG funds appropriated to HHS and received by the Accelerator Hub cannot be used to pay 218 salaries more than the federal Executive Level II salary. 219

It is important to note that this does not limit the amount of salary an Accelerator Hub may compensate an 220 individual, rather it limits the amount of salary that can be paid to an individual using HHS funds. 221

Accounting System 222

The respondent must demonstrate the ability to maintain an accounting system that is capable of tracking 223 the expenditures of USG funds and investments of those funds, given the financial requirements of this 224 partnership. 225

V. MINIMUM ELIGIBILITY CRITERIA 226

All responsible sources capable of satisfying the U.S. Government’s needs may submit a proposal that will 227 be considered by BARDA. Respondents may include a single entity or a consortium of partners. To be 228 eligible for evaluation, the respondent (either individual entity or a consortium of partners) must, at a 229 minimum: 230

• The Respondent must be a U.S.-based Concern and remain a U.S.-based Concern throughout the 231 agreement term. 232 o “U.S.-based Concern” means: (i) incorporated in the United States (including a U.S.-233 incorporated subsidiary even if the parent is foreign-based), or (ii) unincorporated with its 234 principal place of business in the United States. Principal place of business is defined as 235 the primary location where management directs, controls, or coordinates the entity’s 236 activities. 237

BAN 2.0 Solicitation Page 9 of 27 o Note: Components of the work may be performed by a team consisting of subcontractors, 238 consultants, or partner organizations, however, the Respondent must retain responsibility 239 for substantively leading the Accelerator Hub effort. 240

• Demonstrate a record of directly providing wraparound accelerator and commercialization 241 services, and product development, evaluation, and validation services within the past 5 years. 242

• Demonstrate experience building a network of innovators, startups, investors, strategic partners, 243 experts, mentors, and other innovation ecosystem partners within the past 5 years 244

VI. AWARD INFORMATION 245

Period of Performance 246

BARDA anticipates executing one award (“Agreement”) for the Diagnostics/Medical Devices focus area 247 from this solicitation. The Agreement is expected to result in a base period award with 6 additional option 248 periods for a total period of up to 7 years (to align with the periods of performance for the other four hubs), 249 to be exercised at BARDA’s discretion and subject to the availability of funds. 250

Anticipated Funding 251

The initial base funding amount provided to the Awardee for the Diagnostics/Medical Devices focus area 252 under the Agreement will be $2.0 million. The base funding will be used by the Awardee to provide 253 program management services, wraparound accelerator services, DEV services, and project management 254 costs as outlined in Section III. In addition, BARDA intends to structure an agreement that contains annual 255 funding options for continuing wraparound and DEV services in the aggregate amount of $2.0 million. 256

Additionally, the Agreement will be structured to be able to exercise annual or other options at higher 257 amounts. The Agreement is anticipated to include a ceiling of $500 million over the period of the 258

Agreement. BARDA may provide funds for additional wraparound and product DEV services beyond the 259 base amount up to the negotiated ceiling amounts as established in the Agreement, based on BARDA’s 260 priorities and needs, and in the event of a rapid response situation, including, but not limited to, a future 261 pandemic or public health emergency. 262

Respondents are encouraged to propose cost/resource sharing/contributions, which may consist of cash 263 investment or in-kind contributions expressed in U.S. dollars. Greater cost/resource contributions will be 264 considered favorably as part of the respondents’ cost proposal evaluation. 265

VII. ACCESS TO RECORDS & FOREIGN OWNED INTERESTS 266

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Access to Records 267

The USG, at its discretion, will have access to and the right to examine records of the Awardee per the 268 normal course of the Other Transaction Agreement. BARDA may periodically request information from 269 the Awardee, including information on Sub-Awardees and recipients of services funded by this OTA, on 270 technology, financial, and intellectual property (IP) progress to track impact, performance, and progress, 271 and to overcome roadblocks towards accomplishing its mission. 272

Foreign-Owned Interests 273

The Respondent shall ensure that no foreign investment capital or interests from USG prohibited sources 274 list of Embargoed and Sanctioned countries3, as defined by the U.S. Departments of Treasury and 275

Commerce, are utilized by the Respondent. 276

VIII. RIGHTS RESERVED DURING THE SOLICITATION PROCESS 277

BARDA reserves specific rights, in addition to rights by law or regulation, including but not limited to: 278

• The right to request additional, necessary documentation upon initial review. Such additional 279 information may include, but is not limited to, a further detailed proposal, budgets, representations, 280 and certifications. 281

• The right not to select a Respondent’s proposal for award. 282

• The right to remove a Respondent from consideration should (i) the Respondent fail to reach an 283 agreement on terms, conditions, and cost within a reasonable time; (ii) the Respondent fail to 284 provide requested additional information in a timely manner, or (iii) BARDA determines it is in 285 the best interests of the USG. 286

• The right to evaluate and award an Agreement without negotiations with a Respondent. 287

IX. SUBMISSION OVERVIEW & INSTRUCTIONS 288

All interested parties are requested to submit all solicitation-related questions and/or proposal submissions 289 to BAN_Inquiries@hhs.gov. Please submit all questions by 12:00 PM ET on Thursday, April 2nd. All 290 questions submitted and accompanying answers may be made public via a question-and-answer document 291 published as an amendment to this solicitation. Any publicly posted questions and answers will be 292 anonymized and contain no identifying information. DO NOT SUBMIT PROPRIETARY 293

INFORMATION as part of the question-and-answer portion. All questions received will be assumed to 294

3 US Department of Treasury, Office of Foreign Assets Control, Sanctions List Search:

https://sanctionssearch.ofac.treas.gov/ mailto:BAN_Inquiries@hhs.gov

BAN 2.0 Solicitation Page 11 of 27 be non-proprietary. The Government reserves the right to answer or not answer any questions received at 295 its sole discretion. 296

Submissions are due at 12:00 PM ET on April 20, 2026, with the intent to make an award within 90-297

120 days of the proposal due date. BARDA may adjust the closing date for submissions through 298 amendment of this notice. 299

All proposals will be kept confidential and reviewed pursuant to the criteria established. Any interested 300 parties that respond to this solicitation will be deemed a Respondent. BARDA reserves the right to engage 301 with any Respondent, as necessary, to clarify information submitted in the proposal. Respondents not 302 selected for the award will be notified of the decision, but formal debriefings will not be offered. 303

Respondents must be registered in the System for Award Management (SAM) to be eligible for the award. 304

Registration can be completed here: https://www.sam.gov/. 305

X. PROPOSAL PREPARATION 306

All proposal information in response to this solicitation is submitted at no cost or obligation to the 307

Government. Respondents are encouraged to review current programming through the BARDA 308

Accelerator Network4 and propose execution of similar programming for the Diagnostics/Medical Devices 309 technology area. 310

Please submit a proposal consisting of a narrative (including figures, schematics, diagrams, graphics, 311 etc., which must be labeled) that describes the organization’s capabilities, experience, and approach to 312 perform the tasks and responsibilities outlined in sections 1 – 4 below and a separate cost proposal. 313

Please structure proposals in accordance with the sections below. 314

Technical Proposal 316

It is recommended that the technical proposal consist of a cover page, a table of contents, responses to 317 the evaluation criteria (Section XI) and the information requested below- maximum 30 pages total. 318

(The cover page and table of contents do not count toward this total.) Appendices may be provided 319 with the technical proposal, with the appropriate tabs, and are not included in the 30-page limit. 320

Resumes shall be included as part of the technical proposal, but will not count against the 30-page 321 limit. 322

4 To learn more about the current BARDA Accelerator Network, visit https://drive.hhs.gov/accelerators.html https://drive.hhs.gov/accelerators.html

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Cost Proposal 324

It is recommended that the cost proposal consist of a cover page, a table of contents, and the 325 information requested below (cost/price proposal + cost/price workbook) associating cost with 326 identified task and all labor categories and labor rates for work under a prospective agreement- 327 maximum 20 pages total. (The cover page and table of contents do not count toward this total.) 328

Page Limit 330

If a Respondent exceeds either of the above page limits, it does so at its own risk, and the Government 331 reserves the right to not review or consider any information submitted in excess of these limits. 332

1. Summary of Relevant Experience and Past Success 334

This section pertains to current and past success. The Respondent (single entity or a consortium of partners) 335 must include detailed examples of its relevant current and past success. The Respondent should also 336 include the experience and past success of the organization, key personnel, and collaborators who will 337 deliver the objectives of the partnership. All examples should stand on their own without the need for 338 evaluators to do any external research outside of what is provided in the proposal. Proper citations 339

(weblinks, papers, presentations, etc.) and supporting evidence are required in the following areas: 340

a. Experience and Past Success delivering on the requirements outlined in Section III above 341

(a) Wraparound Accelerator services 342

1. Outreach/Networking and Sourcing 343

2. Entrepreneurship and Product Development Education/Training 344

3. Wraparound and Commercialization Services 345

(b) DEV Services 346

(c) Rapid Response Capability 347

b. Experience in successfully identifying and transitioning R&D products from early 348 development to follow-on investment and eventual successful commercialization. 349

c. Experience and success in supporting product development and commercialization with the 350 intent to generate a measurable scientific or social impact that has addressed an unmet need 351 in the life sciences and/or health security landscape. 352

d. Experience and success managing operational functions to meet and maintain requirements of 353 the proposed programming. 354

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2. Organization Capabilities and Key Personnel 356

Respondent (single entity or consortium of partners) should provide an overview of the capabilities it 357 possesses to source innovators and companies, provide Wraparound Accelerator services, DEV, and Rapid 358

Response services as described in Section III in support of national companies aligned with BARDA’s 359 mission. If the Respondent does not currently have all the necessary capabilities, describe how the 360

Respondent plans to scale operations to support Accelerator Hub activities and management. 361

a. Provide an overview of the key personnel and support staff (including key subcontractors, 362 consultants, etc.) who will be responsible for the management and operations of the 363

Accelerator Hub. Provide the following for each of the proposed personnel: 364

(a) Name 365

(b) Description of role, contribution, and proposed level of effort 366

(c) Relevant Experience 367

(d) CV/Resume (attached as an appendix, 1-3 pages, no particular format required) 368

b. Provide a detailed description of how the Respondent will avoid conflicts of interest, if the 369 potential for any conflict exists. It is the Respondent’s responsibility to establish policies and 370 manage all internal conflicts of interest. 371

c. Describe the Respondent’s existing facilities and infrastructure and any future plans, if any, 372 for scale-up to support this partnership. 373

3. Program Design and Technical Approach 374

Respondents (single entity or consortium of partners) should provide an overview of how they envision 375 supporting the following required capabilities of the BARDA Accelerator Network Hub as identified in 376

Section III. Respondents are advised to reference Appendix B: Sample Program Statement of Work and 377

Key Performance Parameters (KPPs) to support their narrative for program design and technical approach. 378

a. Wrap Around Accelerator Services: 379

(a) Sourcing – Describe how innovators and companies will be sourced and any unique 380 processes the Respondent will utilize to identify the best technologies relevant to 381

BARDA’s mission/impact areas. The Respondent must also describe how mentors, 382 experts, and business/commercialization consultants will be sourced to support each 383 company. If the Respondent currently does not have these capabilities, describe how 384 the Respondent will develop and maintain the capabilities. 385

(b) Program Design and Execution – Describe how the Respondent aims to design 386 programming and services for companies at all levels of development across the 387

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TRL scale. Outline any unique processes or components the Respondent will utilize 388 to ensure programmatic success to minimize technical and commercial risks and 389 maximize impact to companies in the programs. 390

(c) Wraparound and commercialization services – Outline the kind and scope of 391 wraparound and commercialization services that the Respondent will provide. 392

Explain which of these services will be provided in-house and, if any, the relevant 393 partners that will be leveraged to provide these services. 394

(d) Outline a sample budget justification and timeline (including operational cost and 395 estimates of hourly costs for consultants/external partners) for the above Sourcing, 396

Program Design and Execution, and wraparound and commercialization services 397 including how many companies the Accelerator will support in a given fiscal year 398 given a proposed budget of up to $500k per year allocated for the Wraparound 399

Accelerator Services. Complete the following for the budget justification: 400

1. Attachment 1 – BAN 2.0 Price Cost Workbook, tab ‘Annual Option – 401

Wraparound 402

2. Written narrative to include the following: 403

a. Timelines for the Wraparound support (outlined in Section III) to 404 companies, based on proposed program design and projected number 405 of companies the Hub will support. 406

(e) Describe how the Respondent will define, track and report on BARDA mission-407 related impact metrics. 408

b. Development, Evaluation, and Validation (DEV) Services: 409

(a) Describe how the Respondent will design a DEV funding program including a 410 description of the approach for sourcing, review, funding mechanisms, project 411 management, and validation services offered to companies under the option funding 412 assumption of $1.5 million per year allocated for DEV services. 413

(b) Describe how the Respondent will provide technical assistance to companies as 414 required in Section III. The approach should empower innovators with core 415 competencies for business and clinical feasibility assistance to increase the 416 technology readiness level of their technology from concept to demonstration to 417 deployment. The Respondent should describe how their physical and virtual 418 environment/support mechanisms will support innovators at all stages to develop, 419 evaluate, validate, and commercialize their products. 420

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c. For base funding assumption of up to $1.5 million per year for DEV services, complete the 421 following as a budget justification: 422

(a) Attachment 1 – BAN 2.0 Price Cost Workbook, tab ‘Annual Option – DEV ($1.5 423 million)’ 424

(b) Written narrative to include the following: 425

1. Timelines for the DEV support (outlined in Section III) to companies 426

(individual projects are intended to conclude within 6 months of the start of 427 the DEV awards), 428

2. Number of funded projects 429

3. How the milestone-based projects will be supported annually. 430

4. Clearly demonstrate how the operational expenses were ascertained as a 431 factor of the 'Proposed Number of Subawards" (as entered in the cost/price 432 workbook) and how/if the operational expenses will fluctuate based on 433 volume of subawards and varying scope of subawards. 434

5. Any additional assumptions to support the details provided in the budget 435 justification 436

4. Rapid Response Capability 437

a. In the event of a rapid response scenario, describe how the Respondent will scale and ramp 438 up Accelerator Hub functions to deliver rapid and scalable solutions in a scenario where 439

BARDA chooses to exercise the option of allocating up to $500 million (subject to availability 440 of funds) to provide rapid response support. 441

b. Outline the Respondent’s organization, partners, and collaborators’ technical approach to 442 quickly pivot and accelerate the development and commercialization of products and to scale 443 up the facilities and expertise in a rapid response scenario such as addressing any public health 444 emergency needs. 445

c. If the Respondent has existing partnerships/infrastructure to support, list the partners within 446 the Respondent’s ecosystem and describe how and for which component they will support the 447 capabilities required of the Accelerator Hub. If no partnerships/infrastructure exists, outline 448 how the respondent aims to identify and partner with external partners. 449

5. Cost/Price Proposal 451

It is anticipated that the pricing structure for each Agreement will consist of a fixed price for (a) 452

Wraparound Accelerator services (up to $500K annually), (b) a fixed price for Development, Evaluation, 453

BAN 2.0 Solicitation Page 16 of 27 and Validation services (up to $1.5 million annually), and (c) a variably structured Rapid Response 454

Capability element that may be fixed price, expenditure based or any appropriate model determined to be 455 in the Government’s best interest. The ceiling on the overall award is up to $500 million over the course 456 of the agreement and would be largely determined by the needs of BARDA and availability of funds. 457

Additionally indicate and describe the proposed cost/resource sharing/proposed contributions, which may 458 consist of cash investment or in-kind contributions expressed in U.S. dollars. 459

The Respondent shall submit the following Cost/Price Proposal volume as follows: 460

1. Written Cost/Price Proposal 461

2. Cost/Price Workbook 462

6.1 Written Cost/Price Proposal 463

The Written Cost/Price Proposal shall be provided in Word (.docx or .doc) or PDF and should detail all 464 the activities included in the proposed fixed price for each service separately as outlined in Section III and 465

Section VI (i.e., Wraparound Accelerator Services, Development, Evaluation, and Validation and Rapid 466

Response Capability). This narrative response should illustrate the Respondent’s understanding of the 467 labor market, and the appropriate labor mix and costs associated with the services above. Note, the fixed 468 amounts for each service area in this section should support all requirements as outlined in Section III and 469 all other administrative activities. It should be inclusive of, but not necessarily limited to: 470

• Program Management Support 471 o Managing operational functions to meet and maintain the requirements of the proposed 472 programming 473 o Reporting requirements, meetings, and other deliverables as outlined in Appendix A 474

• Individual Projects under DEV Services & Rapid Response 475 o Sourcing, review, funding, and management of Individual Project Proposals as outlined 476 under Section III 477 o The direct non-dilutive funding to companies towards their development, evaluation, and 478 validation projects 479 o Wraparound support for funded projects 480 o Provide project management support and project and deliverable oversight to individual 481 projects support 482

6.2 Cost/Price Workbook 483

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The Cost/Price Workbook shall be completed in the format provided in Attachment 1 – BAN 2.0 Price 484

Cost Workbook template. The Respondent should submit any supporting documentation separately as 485 necessary to supplement the cost/price workbook. 486

All proposal information in response to this solicitation is submitted at no cost or obligation to the 487

Government. Interested parties are responsible for adequately marking proprietary or competition-488 sensitive information contained in their response. 489

XI. EVALUATION CRITERIA 490

Eligibility Requirements 491

The eligibility requirements will be reviewed against the minimum eligibility criteria defined in Section 492

V of this solicitation and as follows: 493

• The Respondent must be a U.S.-based Concern and remain a U.S.-based Concern throughout the 494 agreement term. 495 o “U.S.-based Concern” means: (i) incorporated in the United States (including a U.S.-496 incorporated subsidiary even if the parent is foreign-based), or (ii) unincorporated with its 497 principal place of business in the United States. Principal place of business is defined as 498 the primary location where management directs, controls, or coordinates the entity’s 499 activities. 500 o Note: Components of the work may be performed by a team consisting of subcontractors, 501 consultants, or partner organizations, however, the Respondent must retain responsibility 502 for substantively leading the Accelerator Hub effort. 503

• Demonstrated a record of providing wraparound accelerator and commercialization services, and 504 product development, evaluation, and validation services. 505

• Demonstrated experience building a network of innovators, startups, investors, strategic partners, 506 experts, mentors, and other innovation ecosystem partners. 507

If it is determined that the Respondent does not satisfy the minimum eligibility requirements, the proposal 509 will not be evaluated. If it is determined that the Respondent does satisfy the minimum eligibility 510 requirements, the proposal will be evaluated against the evaluation criteria for each of the Required 511

Capabilities (Wraparound Accelerator Services; DEV Services; Rapid Response Capability) and 512 cost/price. 513

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Proposal Evaluations 514

If it is determined that the Respondent’s proposal is eligible and responsive, the proposal will be evaluated 515 against the following evaluation criteria listed below in descending order of importance for each required 516 capability: 517

(a) Summary of Relevant Experience and Past Success 518

(b) Organization Capabilities and Key Personnel 519

(c) Program Design and Technical Approach 520

(d) Cost/Price Proposal 521

Summary of Relevant Experience and Past Success 522

• Wraparound Accelerator Services 523 o The proposal will be evaluated as to whether it demonstrates that its organization and 524 collaborators have the capability and prior experience of establishing and maintaining a 525 network of R&D capabilities and technical and commercialization support that is suitable 526 for accelerating health security innovations to market as well as experience in performing 527 the functions of a business Accelerator. The proposal will also be evaluated as to whether 528 it demonstrates experience in successfully identifying and transitioning R&D products 529 from early development to follow-on investment and eventually successful 530 commercialization. 531

• Development, Evaluation, and Validation Services 532 o The proposal will be evaluated as to whether it demonstrates that the Respondent’s 533 organization and collaborators have the capability and prior experience to source, review, 534 fund, and manage multiple DEV projects and to accelerate the process for innovators to 535 increase the technical and business capabilities of their venture, with experience in how to 536 transition products through the evaluation and testing process required for regulatory 537 approval. 538

• Rapid Response Capability 539 o The proposal will be evaluated as to whether it demonstrates that their organization, 540 partners, and collaborators have the capability and prior experience and/or appropriate plan 541 to quickly pivot, build capacity, and accelerate the development and commercialization of 542 products and to scale-up the facilities and expertise to address the Rapid Response 543

Capability needs. 544

Organization Capabilities and Key Personnel 545

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• Wraparound Accelerator Services 546 o The proposal will be evaluated as to whether it demonstrates that key personnel and support 547 staff (including key subcontractors, consultants, etc.) have the capability and prior 548 experience of evaluating early-stage technologies from a business/commercialization, 549 scientific, and regulatory perspective and to provide commercialization and wraparound 550 support. The proposal will also be evaluated as to whether it demonstrates that the key 551 personnel have the capability and prior experience to provide the functions of a product 552 accelerator. Personnel in place will be viewed more favorably over personnel that may 553 need to be hired. 554

• Development, Evaluation, and Validation Services 555 o The proposal will be evaluated as to whether it demonstrates that the key personnel have 556 the capability and prior experience in bringing early-stage technologies from development, 557 evaluation, and testing to regulatory approval. The applicant should also demonstrate that 558 the key personnel have the capability and prior experience in executing pilot funding 559 programs for targeted product development, testing, rapid prototyping support, and 560 validation based on the individual requirements of the project. Personnel in place will be 561 viewed more favorably over personnel that may need to be hired. 562

• Rapid Response Capability 563 o The proposal will be evaluated as to whether it demonstrates that the respondent can 564 identify the key personnel required to achieve the goal of accelerated development and 565 commercialization quickly and nimbly. This should include a recruitment plan for adequate 566 staffing and expertise. 567

Program Design and Technical Approach 568

• Wraparound Accelerator Services 569 o The proposed program design and technical approach will be evaluated as to whether it: 570 is viable, realistic, and capable of satisfying the goals outlined in Section III and 571 in accordance with Section X. 572

Fosters and identifies a promising early-stage R&D portfolio of national health 573 security products and technology innovation. 574

Fosters a physical and virtual environment that is programmed to increase 575 collaboration and spur product innovation. 576

Supports the business and entrepreneurial needs and development of innovators by 577 providing wraparound support capabilities and services. 578

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• Development, Evaluation, and Validation Services 579 o The proposed program design and technical approach will be evaluated as to whether it: 580

Is viable, realistic, and capable of satisfying the goals outlined in Section III and 581 in accordance with Section X. 582

Empowers innovators with core competencies for business and clinical feasibility 583 assistance to increase the technology readiness level of their technology from 584 concept to demonstration to deployment. 585

Creates a physical and virtual environment that will support innovators at all stages 586 to develop, assess, evaluate, and translate/commercialize their products. 587

• Rapid Response Capability 588 o The proposed program design and technical approach will be evaluated as to whether: 589

It is viable, realistic, and capable of satisfying the goals outlined in Section III and 590 in accordance with Section X. 591

The facilities,…