BARDA Prize Solicitation 6.30.2023.pdf

Biomedical Advanced Research and Development Authority (BARDA) Call for

Submissions for BARDA Other Transaction Prize Vehicle

June 30, 2023

Biomedical Advanced Research Development Authority (BARDA)

Contracts Management & Acquisition (CMA)

400 7th Street, SW, Washington, DC 20024

MedicalCountermeasures.gov i

Contents

I. BACKGROUND

II. OBJECTIVES

Description

III. REQUIREMENTS

Overview

Minimum Eligibility Requirement for Prospective Respondents

Responsibilities

Avoiding Organizational Conflicts of Interest (OCI)

Salary Rate Limitation

Accounting System

IV. ANTICIPATED TERMS OF AWARD

V. ACCESS TO RECORDS & FOREIGN OWNED INTERESTS

Access to Records

Foreign-Owned Interests

VI. PROPOSAL PREPARATION AND SUBMISSION INSTRUCTIONS

Notice of Intent

Overview

1. Technical Approach and Relevant Experience

2. Organizational Capacity

3. Key Personnel

4. Price

VII. QUESTIONS

VIII. EVALUATION CRITERIA

IX. AWARD DECISION

X. APPENDIX

I. BACKGROUND

Within the Administration for Strategic Preparedness and Response (ASPR), the Biomedical 1 Advanced Research and Development Authority (BARDA) has created a Strategic Plan for 2 2022- 2026 focused on strengthening the health security of the nation and embracing lessons 3 learned from the COVID-19 pandemic. 4

During the COVID-19 response, BARDA spent considerable resources screening and selecting 5 candidate organizations to make substantial investments in COVID-19 vaccine, therapeutic, 6 diagnostic, and other medical countermeasure (MCM) technology development, reviewing 7 over 4500 market research submissions, conducting close to 700 meetings with potential 8 organizations, and issuing $65 billion in awards to 140 organizations for COVID-19 research 9 and development. 10

While these investments were crucial to receiving Emergency Use Authorization from the 11 Food and Drug Administration for countermeasures and providing hundreds of millions of 12 lifesaving COVID-19 MCMs to the public, multiple approaches were needed to accelerate 13 MCM research and development. 14

This Prize Vehicle seeks to catalyze, in complement traditional contract-based funding 15 mechanisms, the research and development (R&D) and commercialization of MCMs, to meet 16 ambitious goals set by BARDA and other relevant stakeholders including goals in the BARDA 17 Strategic Plan and national initiatives, such as the National Biodefense Strategy and 18 Implementation Plan and Project NextGen1 . This Prize Vehicle will enable BARDA to establish 19 clear success metrics and offer cash prizes contingent on meeting clear sets of success criteria 20 among competing R&D organizations as well as help to 1) create high visibility to address 21 health security problems, sometimes when the approach or development path is not known 22

2) increase the diversity and reach of organizations to engage in MCM R&D development and 23

3) develop solutions that meet bold and ambitious goals that thrive beyond prize award. 24 The resulting awards from the Prize Vehicle will be issued as an Other Transaction, leveraging 25 BARDA’s Other Transaction Authority (OTA)2. 26

II. OBJECTIVES 28

Description 29

BARDA, through this Prize Vehicle, seeks to partner with an organization with the expertise to 30 design, promote, and administer effective prize competitions to catalyze product development 31 and address ambitious BARDA goals. 32

Specifically, BARDA is seeking to partner with an organization who will achieve the following 33 objectives: 34

• Design: Work with the government and other stakeholders to design incentive prize 35 competition(s) to catalyze the research and development of products and 36 capabilities to meet ambitious goals set by BARDA 37

• Promote: Provide outreach 1) to eligible participant communities (e.g. product 38 developers) to increase diversity of participants or teams of participants; 2) to 39 partnering organizations to increase additional public/private investment and 40 interest; and 3) to the public to raise awareness and create high visibility to address 41 a product development problem or gap 42

• Administer: Coordinate and administer the prize competition(s) with BARDA and 43 participants, including awarding of cash prizes and other rewards. 44

III. REQUIREMENTS 45

Overview 46

Respondents to this solicitation shall detail their approach, experience, and capabilities to meet 47 the objectives and requirements for the Prize Vehicle as outlined in this solicitation. While 48 Respondents will be outlining their approach to address the Vaccine Patch competition as 49 detailed below, BARDA reserves the right to issue additional prize competitions under any OT 50 resulting from this solicitation, up to an overall ceiling not to exceed $100 million for all prize 51 competitions (inclusive of prize purses) and associated services. 52

Vaccine Patch Prize competition 53

Project NextGen seeks to accelerate the development of the next generation of COVID-19 54 vaccines, therapeutics and enabling technologies including a plan to launch a $50 million 55 international competition to catalyze the development of clinical evidence, regulatory approval 56 and commercialization of patch-based vaccine delivery for a combination vaccine product, such 57 as COVID-19 and seasonal influenza or vaccines for other respiratory pathogens in addition to 58 COVID-19. Patch-based vaccine technologies have the potential to reduce the amount of 59 antigen needed in a safe and effective vaccine dose, reduce cold-chain requirements, improve 60 the experience of vaccination that could drive up adoption rates, and provide added 61 convenience with the potential for self-administration. The first award under the BARDA Prize 62 OT is assumed to design, promote, and administer this competition. The structure of the 63 competition is anticipated to be a first-to-finish competition, consisting of multiple rounds with 64 multiple intermediate finalists and a single final winner that’s focused on milestones tied to 65 advanced clinical development, regulatory approval, and/or commercialization. Eligible finalists 66 and winners are expected to consist of collaborations between vaccine and patch developers. 67

Minimum Eligibility Requirement for Prospective Respondents 68

In order to be eligible for consideration, respondents should have executed a life science 69 and/or biomedical R&D focused prize competition from design phase to awarded winner(s), for 70 which the focus was the development of a medical product, whether a drug, device, or other 71 clinical product. 72

Responsibilities 73

Task 1: Prize competition design 74

• Awardee will be expected to translate BARDA needs to scope out a project plan and 75 prize competition. BARDA has deep in-house subject matter expertise to assist with 76 milestone development which is anticipated to reduce the overall design timeline and 77 obviate the need to seek similar experts externally. 78

• Conduct technical research and market analyses to better understand problem and 79 solution space for a given set of objectives. 80

• Conduct analysis on incentives and considerations to target participant community to 81 meet BARDA goals 82

• Advise on the optimal structure and design for a prize competition given the goals for 83 that prize competition. 84

• BARDA stakeholders may include personnel sourced from federal government, 85 academia, industry and other sectors as deemed relevant. Awardee will administer and 86 manage Non-Disclosure Agreements to these stakeholders. 87

• Propose plan for eligibility criteria, submission instructions, evaluation criteria, 88 terms/conditions, and prize competition schedule in conjunction with BARDA and 89 BARDA stakeholders, including management of conflicts of interest for participants and 90 stakeholders, and intellectual property rights consistent with industry best practices 91

Task 2: Prize competition promotion 92

• Draft all communication materials needed to promote the prize competition, attract and 93 incentivize participants and inform key stakeholders including the general public on the 94 intent of and progress on the prize 95

• Draft all communication materials intended to regularly update senior staff within 96 BARDA, ASPR, and HHS on the progress of the prize competition 97

• Build and manage a website with a unique URL that will serve as the central public 98 source for all prize information 99

• Host at least two in-person public meetings as part of the prize competition, with one 100 close to the District of Columbia and the other close to the awardee’s location. These 101 meetings can include partnering/teaming opportunities among likely participants, 102 particularly between vaccine and patch developers; and winner 103 announcement/demonstrations. 104

• Provide analytics on efficacy of marketing including project page orientation, social 105 media amplification and other engagement metrics 106

Task 3: Prize competition administration 107

• Incorporate final eligibility criteria, submission instructions, evaluation criteria, 108 terms/conditions and prize competition schedule into website 109

• Coordinate prize competition with all participants and BARDA stakeholders including 110 defined process for solution/product submission, evaluation and selection 111

• Provide access, relevant training and hosting capabilities for tools to support the prize 112 competition. 113

• Verify that potential winners meet eligibility criteria. 114

• Administer prize funding to winners as determined by judging criteria and approved by 115

BARDA 116

• Provide testing service for participants to validate technologies, as appropriate based on 117 the design of the prize competition. The Vaccine Patch Prize is not currently anticipated 118 to require any testing services. 119

• Provide usability or user input as needed on a case-by-case basis, including for the 120 Vaccine Patch Prize 121

Avoiding Organizational Conflicts of Interest (OCI) 123

Respondents must disclose whether they are currently providing professional 124 consulting services1 to any part of the USG. Respondents must also disclose if any 125 individual member of their proposed team has provided professional consulting 126 services previously to ASPR/BARDA within the previous three years from the date of 127 the release of this solicitation. A determination will then be made whether a 128 respondent has a conflict of interest and whether an appropriate mitigation plan is 129 feasible. If this relationship is determined to create a conflict of interest that cannot be 130 mitigated, then the individual or entity will be ineligible to be a part of the proposal. 131 Further, any individual/organization who has provided professional consulting services 132 previously to BARDA on this specific announcement is ineligible to respond. 133

As part of the proposal submission, all members of the proposed team (including any 134 potential subcontractors or consultants) must affirm if their organizations and/or 135 individual team members have provided any professional consulting services in support 136 of any USG agency in the past three years. Adequate information about the services 137 rendered must be provided to allow BARDA to make this determination. 138

1 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.

If professional consulting services are currently, or have been, provided to any USG 139 program(s) by a member of a proposed team, the proposal must include the following: 140

a) The name of the USG program office receiving the support 141

b) The contract/grant/agreement number 142

c) Identification of proposed team member (e.g., sub-awardee, consultant) providing 143 the support 144

d) A proposed OCI mitigation plan. 145

All personnel involved in the development, administration, and judging of the 147 challenge(s), including the prize vendor and BARDA stakeholders, will be required to fill 148 out a Non-Disclosure Agreement to outline Conflicts of Interest & Rules of Conduct. Any 149 personnel deemed by BARDA to have a conflict may be excluded from further 150 involvement. 151 Salary Rate Limitation 153

HHS is bound by annual appropriations laws that direct that HHS funds cannot be used to pay 154 extramural salaries at a rate more than Executive Level II ($212,100 as of fiscal year 2023). 155 Accordingly, USG funds appropriated to HHS and received by the Awardee cannot be used to 156 pay salaries more than the federal Executive Level II salary. 157

It is important to note that this does not limit the amount of salary an Awardee may 158 compensate an individual, rather it limits the amount of salary that can be paid to an 159 individual using HHS funds. 160

Accounting System 161

The respondent must demonstrate the ability to maintain an accounting system that is 162 capable of tracking the expenditures of USG funds. 163

IV. ANTICIPATED TERMS OF AWARD 165

It is BARDA’s intent that the agreement will be entered into through BARDA’s Other 166 Transaction authority.2 The anticipated initial period of performance resulting from this 167 solicitation is 5 years, including the design phase, an estimated 3-year competition, and post-168 award services. BARDA may incorporate additional prize competitions under this Prize Vehicle 169 up to an overall ceiling of $100 million for all prize competitions (inclusive of prize purses) and 170 associated services. 171

2 See 42 U.S.C. 247d-7e(a)(3)

V. ACCESS TO RECORDS & FOREIGN OWNED INTERESTS 173

Access to Records 174

The USG, at its discretion, will have access to and the right to examine records of the Awardee 175 per normal course of the Other Transaction Agreement. BARDA may periodically request 176 updates from the Awardee, as well as from the Prize Recipients, on market research, updates 177 on discussions with other interested stakeholders to include relevant subject matter experts 178 and potential funding partners as well as interactions with participants in order to track 179 impact, performance and progress. These requests would be in addition to the reporting 180 requirements outlined in Appendix A. These updates and reports will be considered 181 confidential and shared on a need-to-know basis within USG. 182

Foreign-Owned Interests 183

The Awardee shall ensure that no participants in the competition have foreign investment 184 capital/interests from USG prohibited sources list of embargoed and sanctioned countries, as 185 defined by U.S. Departments of Treasury and Commerce, are utilized by the Awardee. See also 186 the Foreign Ownership, Control, or Influence (FOCI) Plan requirement included in Appendix A. 187

VI. PROPOSAL PREPARATION AND SUBMISSION INSTRUCTIONS 189

All submissions will be kept confidential and will be reviewed pursuant to established criteria. 190

Respondents must be registered in the System for Award Management (SAM) to be eligible for 191 award. (NAICS: 541714) Registration can be completed here: https://www.sam.gov/. 192

Interested parties should submit all documents required to respond to this solicitation via 193 email to VaccinePatch@hhs.gov no later than July 31, 2023 at 12:00PM ET. 194

All submissions should consist of a narrative (including figures, schematics, diagrams, graphics, 195 etc., which must be labeled) that describes the organization’s approach, experience, and 196 capabilities, for performing the Objectives and Responsibilities outlined previously as well as 197 its capabilities in accordance with the below. 198

Notice of Intent 200

1. Respondent must notify BARDA, via email, of their intent to submit a proposed 201 approach to the requirement and include the name of the Respondent as well as 202 prospective organizations with whom the Respondent may partner with as a 203 https://www.sam.gov/ mailto:VaccinePatch@hhs.gov subcontractor or consultant who will be participating in the decision making or has 204 decision authority. Notices of intent should be sent to VaccinePatch@hhs.gov by 205 12:00PM ET on July 14, 2023. 206

Proposal Structure 208

Overview 209

Please structure proposals in accordance with the sections below. 210

1. Technical Approach and Relevant Experience 211

The Respondent should include a narrative overview for meeting the objectives and 212 responsibilities outlined in this solicitation, including concepts to address Vaccine Patch 213 competition. This can include potential partnerships, key subject matter experts, collaborations, 214 and existing resources, as well as identified risks and proposed risk mitigation approaches. The 215 Respondent should also include an overview of related previous prize competitions performed, 216 including relevant large-scale health competitions. This section should not exceed 3 pages. 217

2. Organizational Capacity 218

The respondent should include an overview on how they address management, communication 219 and reporting. This section should not exceed 3 pages. 220

a. Management – Respondents should address their design phase – including 221 processes to streamline coordination from government defined problem to 222 compelling competitions to improve outcomes; coordination of relevant 223 stakeholders and defined processes for solution/product submissions, evaluation 224 and selection 225

b. Communication – Respondents should address ability to conduct outreach to build 226 participation and engagement. Respondents should also address ability to develop a 227 communication plan for BARDA including website and outreach campaigns. 228

c. Reporting – Respondents should address process to obtain effectiveness of 229 marketing, process to address progress to BARDA as well as process to verify 230 eligibility and provide prize payments to winners 231

3. Key Personnel 232

The respondent should provide the following for each key personnel and support staff 233 (including key subcontractors, consultants, etc.) dedicated to the prize competition. There is no 234 page limit for this section. 235

a. Name 236

b. Description of role and contribution 237

c. CV/Resume (attached as appendix) 238

4. Price 239

It is anticipated that the Agreement awarded as a result of this solicitation will be firm fixed 240 price. BARDA intends to include the $50 million prize purse for the Vaccine Patch Prize as an 241 obligation on this Agreement, to be paid to successful competitors upon authorization from 242 BARDA. The Price Proposal shall be provided in Word (.docx or .doc) or PDF and should detail: 243

(1) all the activities included in the firm fixed price for tasks outlined under Section II and (2) 244 associated labor, travel, equipment and material to address activities and appropriately 245 manage the competition and BARDA partnership. There is no page limit for this section. 246

• Travel to include up to 3 people to attend 2 meetings per year to the DC area for 3 years 247

• Monthly reporting and virtual meetings 248

All proposal information in response to this solicitation is submitted at no cost or obligation 249 to the Government. Interested parties are responsible for adequately marking proprietary 250 or competition-sensitive information contained in their response. 251

VII. QUESTIONS 253

Please submit all questions to VaccinePatch@hhs.gov by 12:00PM ET on July 14, 2023. All 254 questions submitted and accompanying answers may be made public. All answers will be 255 anonymized and contain no identifying information. Do NOT SUBMIT PROPRIETARY 256 INFORMATION. All information received will be assumed to be non-proprietary. 257

VIII. EVALUATION CRITERIA 259

Minimum Eligibility Requirements 260

In order to be eligible for consideration, respondents should have executed a life science 261 and/or biomedical R&D focused prize competition from design phase to awarded winner(s). 262 Submissions that meet the Minimum Eligibility Requirements will then be evaluated against 263 the following criteria, which are listed in descending order of importance. 264

1. Merit of Proposed Approach 265

2. Organizational Capability 266

3. Price 267

Criterion 1. Merit of Proposed Approach 268

a. Did the respondent provide compelling concepts/ideas to address the problem 269 and/or need that can ultimately be developed into a project plan using a prize 270 competition? 271

b. Does the respondent’s organization demonstrate the capability and prior 272 experience to run life science and/or biomedical R&D focused prize competitions 273 including all tasks outlined in this solicitation? 274

c. Is the respondent’s organization able to bring in key subject matter experts to 275 address the problem outlined in the solicitation? 276

d. Can the respondent provide access to relevant communities for participation or 277 collaboration? 278

e. Did the respondent identify appropriate risks and propose approaches to mitigate 279 those risks? 280

Criterion 2. Organizational Capability 283

a. Management - 284

i. Does the respondent have clear processes to coordinate with government 285 to refine problem into a compelling competition to improve outcomes? 286

ii. Does the respondent have expertise to coordinate the prize competition 287 with all relevant stakeholders? 288

iii. Does the respondent have a defined process for solution/product 289 submission, evaluation and selection based on prize competition 290 requirements? Specific criteria will be developed in conjunction with 291

BARDA. 292

b. Communication 293

i. Does the respondent demonstrate an ability to conduct media 294 coordination and outreach to build participation and engagement? 295

ii. Does the respondent include relevant expertise to develop a 296 communication plan for BARDA approval including a website and outreach 297 campaign? 298

c. Reporting 299

i. Does the respondent have an established process to provide prize 300 payments to winners including verifying eligibility? 301

ii. Does the respondent have the capability to provide efficacy of marketing? 302

E.g. analytics on project page orientation, social media amplification 303 metrics, and other engagement metrics 304

iii. Is there a dedicated person to report progress, risks, mitigation 305 approaches and other requirement to BARDA and other relevant 306 stakeholders? 307

Criterion 3. Price 309

The Government will evaluate the proposed price for reasonableness and overall best value to 310 the Government. Proposals will be reviewed to determine if the price proposed reflects an 311 adequate understanding of the requirements and the objectives of the solicitation, and is 312 consistent with the Respondent’s technical approach. 313

For each evaluated proposal, Criterion 1 and Criterion 2 will each be assigned one of the ratings 314 below: 315

Evaluation Definitions 316

• Outstanding: The proposal indicates an exceptionally thorough and comprehensive 317 understanding of the program goals and the methods, resources, schedules, and other 318 aspects essential to performance of the program. The risk of unsuccessful performance 319 is extremely low. 320

• Good: The proposal indicates a good understanding of the program goals and the 321 methods, resources, schedules, and other aspects essential to performance of the 322 program. The risk of unsuccessful performance is very low. 323

• Acceptable: The proposal indicates an adequate understanding of the program goals 324 and the methods, resources, schedules, and other aspects essential to performance of 325 the program. The risk of unsuccessful performance is low. 326

• Unacceptable: The proposal indicates a lack of understanding of the program goals and 327 the methods, resources, schedules, and other aspects essential to the performance of 328 the program. The risk of unsuccessful performance is high. 329

IX. AWARD DECISION 331

BARDA expects to make a single award to a Respondent who proposes the greatest overall 332 value to the USG in accomplishing its program objectives. Each proposal will be evaluated and 333 scored on its individual merit. BARDA reserves the right to engage with any of the 334 Respondents (in-person or via teleconference), as necessary, to make a best value 335 determination as part of this decision process. 336

Following this initial evaluation, the Respondent whose submission appears to offer the best 337 value to the USG will be invited to enter negotiations with intent to reach and execute an 338 Agreement. Through this process, if it is determined that the Respondent does not offer best 339 value to the USG or mutual agreement on the terms cannot be reached, another Respondent 340 may be invited to enter negotiations. BARDA reserves the right to remove a Respondent from 341 consideration or decide to not issue an award from this announcement. Those Respondents 342 not selected for award will be notified of the decision, but formal debriefings will not be 343 offered. 344

X. APPENDIX 346

Appendix A: Deliverables and Reporting Requirements 347

The Awardee shall comply with the following BARDA standard Deliverable and Reporting 348 Requirements: 349

Deliverable Description

Content Requirements and Instructions3

Reporting Frequency4

Kick Off Meeting Awardee to develop Agenda and host an in-person or virtual kick-off meeting to discuss overall project objectives, key personnel, deliverables, risks, schedule, and funding/payment procedures.

Provide meeting minutes.

Kickoff meeting conducted within 10 business days of award.

Minutes to be submitted within 3 business days of meeting.

Ad-hoc Project Team Meetings

Awardee to schedule and create and agenda. Follows Agenda mutually agreed upon in advance of meeting.

Awardee to provide meeting minutes within 3 business days from date of meeting.

As needed for special topics, when specifically requested by OTAO or (OTTR).

Monthly Project Progress Report

A robust monthly report detailing the status of budget, project performance (i.e., Milestones reached) and schedule progress noting variance from previous month’s report. Include status of project delays, risk management, funding issues. Feedback or revisions are to be incorporated in future reports.

Due monthly. Due date TBD by Awardee aligning for monthly consistency. Awardee report format acceptable with USG content requirements at a minimum. Initial report delivered in Microsoft Word or equivalent for ease of edits and final in PDF for USG record keeping.

Monthly Project Team Meetings

Purpose is to review monthly progress report findings, any changes since last month and any projected issues or challenges.

Virtual. Monthly, approximately 5 business days after the monthly report deliverable. 1 hour duration, hosted by the Awardee.

Minutes to be submitted within 3 business days of meeting.

Quarterly In-Process Review (IPR)

Organized, scheduled, and hosted by Awardee. May be virtual or physical at the at a location mutually agreed upon by USG and the Awardee. High level project progress review of overall objectives. Updated projections against project expectations, including risks

Every 3 months from start of project. To review progress over the previous 3 months

Awardee to send slide deck 3 business days in advance of meeting.

3 Unless otherwise specified, Awardee’s format is acceptable. Submissions may be in MS Office or PDF format.

Funding and schedule information shall be MS Excel and MS Project, respectively.

4 Unless otherwise specified, ALL deliverables shall be emailed to the Other Transaction Agreements Officer (OTAO) and Other Transaction Technical Representative (OTTR) listed in the Agreement, AND uploaded to USG-specified database/folder.

Deliverable Description

Content Requirements and Instructions3

Reporting Frequency4 and mitigation plans, shall be presented with respect to the last quarterly.

Minutes to be submitted within 3 business days of meeting.

Integrated Master Project Schedule

Detailed project schedule, full detailed schedule for entire project, including all major activities, critical path, and milestones for USG progress tracking.

Status updated regularly. Schedule presented in monthly report shall show details of at least the upcoming 6 months, preferably with no subtask more than 2 weeks in duration. If showing beyond 6 months, the schedule can be less granular but shall show the major milestones through completion of the effort. This will include all 75% spending ceilings reached and any critical path issues.

Status updated monthly to be submitted with monthly report.

Format requested: Microsoft Project

Project Budget Full detailed budget for entire Project, incorporating original proposal, changes, current projections, and any escalation in cost, with all applicable sub-budgeted categories of total project included as provided in proposal to USG.

Status updated monthly to be submitted with monthly project progress report with summary provided during monthly meetings.

Required format: Microsoft Excel

Project Action Items List

Actions identified throughout the project, which are not tracked by some other project management tool, and which require follow up and monitoring for completion, will be captured in an Action Items List, or similar list/tracking tool. List should contain information regarding identification date, target completion, responsible individuals/groups, etc.

Submitted if/as required with monthly project progress report.

Annual Project Progress Report

High level project progress review of overall objectives. Updated projections against project expectations, including risks and mitigation plans, should be reported with respect to the previous annual report. Summary of critical changes that took place over the year.

Recommended to not exceed 20 pages.

Annually from start of project. To review progress over the previous 12 months. A Draft to be submitted 30 days after the completion of each year of performance. Within 15 days of receipt, the Government will provide review comments. The

Deliverable Description

Content Requirements and Instructions3

Reporting Frequency4

Contractor shall respond within 15 days of receipt of comments.

Report format: Microsoft Word and PDF

Final Report Final report summarizing stated objectives and the progress that was achieved in meeting those objectives;

summary of risks incurred, impacts and mitigation; quantitative discussion of production improvements achieved;

financial summary of project; schedule summary for project, analytics on efficacy of marketing and other engagement metrics, comparing original schedule to final schedule;

recommendations for path forward as applicable.

Initial submission to be submitted 30 days prior to the end of the validation portion of the project. Within 15 days of receipt, the Government will provide review comments. The Contractor shall respond within 15 days of receipt of comments.

Foreign Ownership, Control or Influence (FOCI) Plan

The FOCI plan will encompass the necessary compliance and security as well as decision points for BARDA.

If requested by BARDA, within the first 90 days post-award, the FOCI plan will be delivered to BARDA for review and acceptance. After the plan is submitted, the Government will provide review comments. The Contractor shall respond within 15 days of receipt of comments.

Specific formats, contents, and timelines for these reports will be finalized during negotiations. 350