BARDA BioMaP-Consortium Solicitation_07.31.23.pdf

Biomedical Advanced Research and Development Authority (BARDA)

Biopharmaceutical Manufacturing

Preparedness Consortium (BioMaP – Consortium)

July 31, 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 AND REQUIREMENTS

III. MISCELLANEOUS CONDITIONS

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. Relevant Experience

2. Key Personnel

3. Organizational Capabilities and Consortium Management

4. Expenditure/Price Proposal

VII. QUESTIONS

VIII. EVALUATION CRITERIA

IX. AWARD DECISION

X. DRAFT Deliverables and Reporting Requirements

I. BACKGROUND

The ability of the United States Government (USG) to develop, procure, and secure access to 1 critical medical technologies, products, and supplies is interlinked with national, health, and 2 economic security interests. The USG is heavily dependent upon the private sector for 3 biopharmaceutical Research & Development (R&D), including medical countermeasure (MCM) 4 development, to protect these security interests and ensure that the nation can mitigate the 5 threat of biological incidents. The mission of the Department of Health and Human Services 6 (HHS) Administration for Strategic Preparedness and Response (ASPR) Biomedical Advanced 7 Research and Development Authority (BARDA) is ‘to develop and procure needed medical 8 countermeasures, including vaccines, therapeutics, diagnostics, and non-pharmaceutical 9 countermeasures, against a broad array of public health threats, whether natural or intentional 10 in origin’.1 BARDA was created to address gaps in the USG medical countermeasure 11 development, principally by ensuring strong partnerships with, and incentives for, private 12 sector actors involved in the manufacturing of these critical medical products and supplies. 13

Since 20122, BARDA has created these partnerships, in part, through Centers for Innovation in 14 Advanced Development and Manufacturing (CIADMs), aimed at engaging industry partners to 15 provide expertise and infrastructure to develop and manufacture medical countermeasures 16 such as vaccines and therapeutics to respond to public health emergencies (PHE). As the USG 17 looks to strengthen preparedness and response capabilities for future pandemics, BARDA finds 18 itself at a critical inflection point to re-envision and transform the way government interfaces 19 and partners with the private sector to achieve its mission. 20

This transaction will help improve an industrial and manufacturing base for medical 21 countermeasures during crises and inter-crises, to include the requisite capabilities, flexibilities, 22 and strategies to secure needed medical supplies for the nation’s public health preparedness 23 and response. This work aligns with several stated USG objectives in the realm of pandemic 24 preparedness, and the bio-preparedness and public health industrial base, including the 25 American Pandemic Preparedness Plan (referred to as AP3)3, Executive Order 138064, Executive 26 Order 140015, and Executive Order 140176. 27

A major component to improving preparedness and response is the formation of the 28 Biopharmaceutical Manufacturing Preparedness Consortium (BioMaP-Consortium) supported 29 by the Pharmaceutical Countermeasure Infrastructure (PCI) Division and Biopharmaceutical 30

1 https://www.phe.gov/about/barda/stratplan/Pages/barda-vision-mission-and-values.aspx#:~:text=BARDA's%20mission%20is%20to%20develop,natural%20or%20intentional%20in%20origin 2 https://www.defense.gov/News/Releases/Release/Article/2311228/hhs-reserves-and-rapidly-expands-manufacturing-capacity-for-covid-19-vaccines-a/ 3 https://www.whitehouse.gov/wp-content/uploads/2021/09/American-Pandemic-Preparedness-Transforming-Our-Capabilities-Final- For-Web.pdf?page=29 4 https://www.federalregister.gov/documents/2017/07/26/2017-15860/assessing-and-strengthening-the-manufacturing-and-defense-industrial-base-and-supply-chain 5 https://www.federalregister.gov/documents/2021/01/26/2021-01865/a-sustainable-public-health-supply-chain 6 https://www.whitehouse.gov/briefing-room/presidential-actions/2021/02/24/executive-order-on-americas-supply-chains/ https://www.phe.gov/about/barda/stratplan/Pages/barda-vision-mission-and-values.aspx#:%7E:text=BARDA's%20mission%20is%20to%20develop,natural%20or%20intentional%20in%20origin https://www.phe.gov/about/barda/stratplan/Pages/barda-vision-mission-and-values.aspx#:%7E:text=BARDA's%20mission%20is%20to%20develop,natural%20or%20intentional%20in%20origin https://www.defense.gov/News/Releases/Release/Article/2311228/hhs-reserves-and-rapidly-expands-manufacturing-capacity-for-covid-19-vaccines-a/ https://www.defense.gov/News/Releases/Release/Article/2311228/hhs-reserves-and-rapidly-expands-manufacturing-capacity-for-covid-19-vaccines-a/ https://www.whitehouse.gov/wp-content/uploads/2021/09/American-Pandemic-Preparedness-Transforming-Our-Capabilities-Final-For-Web.pdf?page=29 https://www.whitehouse.gov/wp-content/uploads/2021/09/American-Pandemic-Preparedness-Transforming-Our-Capabilities-Final-For-Web.pdf?page=29 https://www.federalregister.gov/documents/2017/07/26/2017-15860/assessing-and-strengthening-the-manufacturing-and-defense-industrial-base-and-supply-chain https://www.federalregister.gov/documents/2017/07/26/2017-15860/assessing-and-strengthening-the-manufacturing-and-defense-industrial-base-and-supply-chain https://www.federalregister.gov/documents/2021/01/26/2021-01865/a-sustainable-public-health-supply-chain https://www.whitehouse.gov/briefing-room/presidential-actions/2021/02/24/executive-order-on-americas-supply-chains/

Manufacturing Preparedness (BioMaP) Branch of BARDA. The envisioned consortium will be 31 comprised of industry partners across the drug and vaccine manufacturing supply chain, 32 including the manufacturers of required raw materials and consumables, and suppliers of fill-33 finish services. 34

The utilization of third-party, professional Consortium Management Firms (CMF) has proven 35 to be an effective strategy for managing consortia implemented by other Federal agencies. 36 As such, the BioMaP Branch of BARDA has a specific need to establish an agreement, through 37 BARDA’s Other Transaction Authority (OTA), with a CMF. 38

This new vehicle will be leveraged to support future BARDA requirements, as BARDA 40 implements new programs in alignment with National (e.g., National Biodefense Strategy, 41 American Pandemic Preparedness Plan [APPP]) and HHS strategies (e.g., ASPR Strategic Plan for 42 2022-2026, BARDA Strategic Plan, HHS Pandemic Influenza Plan 2017 Update), subject to 43 appropriations and need. 44

II. OBJECTIVES AND REQUIREMENTS 46

Refer to Attachment A – Statement of Objectives (SOO) for a complete description of the 47 objectives and requirements. 48

III. MISCELLANEOUS CONDITIONS 50

Avoiding Organizational Conflicts of Interest (OCI) 52

Respondents must disclose whether they are currently providing professional 53 consulting services7 to any part of the USG. Respondents must also disclose if any 54 individual member of their proposed team has provided professional consulting 55 services previously to ASPR/BARDA within the previous three years from the date of 56 the release of this solicitation. A determination will then be made in BARDA’s best 57

7 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.

business judgment, whether a respondent has a conflict of interest and whether an 58 appropriate mitigation plan is feasible. If this relationship is determined to create a 59 conflict of interest that cannot be mitigated, then the individual or entity will be 60 ineligible to be a part of the proposal. Further, any individual/organization who has 61 provided professional consulting services previously to BARDA on this specific 62 announcement is ineligible to respond. 63

As part of the proposal submission, all members of the proposed team (including any 64 potential subcontractors or consultants) must affirm if their organizations and/or 65 individual team members have provided any professional consulting services in support 66 of any USG agency in the past three years. Adequate information about the services 67 rendered must be provided to allow BARDA to make this determination. 68

If professional consulting services are currently, or have been, provided to any USG 69 program(s) by a member of a proposed team, the proposal must include the following: 70

a) The name of the USG program office receiving the support 71

b) The contract/grant/agreement number 72

c) Identification of proposed team member (e.g., sub-awardee, consultant) providing 73 the support 74

d) A proposed OCI mitigation plan. 75

Salary Rate Limitation 76

HHS is bound by annual appropriations laws that direct that HHS funds cannot be used to pay 77 extramural salaries at a rate more than Executive Level II ($212,100 as of fiscal year 2023). 78 Accordingly, USG funds appropriated to HHS and received by the CMF cannot be used to pay 79 salaries more than the federal Executive Level II salary. 80

It is important to note that this does not limit the amount of salary a CMF may compensate an 81 individual, rather it limits the amount of salary that can be paid to an individual using HHS 82 funds. 83

Accounting System 84

The Respondent must demonstrate the ability to maintain an accounting system that is 85 capable of tracking the expenditures of USG funds and investments of those funds. 86

IV. ANTICIPATED TERMS OF AWARD 88

BARDA intends that the agreements would be entered into through BARDA’s Other 89

Transaction authority.8 The anticipated initial term of performance for an agreement resulting 90 from this solicitation is 10 years. For proposal purposes, to accommodate a large-scale 91 response to a PHE, the anticipated ceiling for the BioMaP-Consortium over the 10-year period 92 of performance is $20 billion. Additionally, Intellectual Property (IP) rights shall be determined 93 prior to award. 94

V. ACCESS TO RECORDS & FOREIGN OWNED INTERESTS 96

Access to Records 97

The USG, at its discretion, will have access to and the right to examine records of the CMF per 98 normal course of the Other Transaction Agreement. BARDA may periodically request 99 information from the CMF, including information from Consortium Members, that include 100 technology, financial, and IP progress in order to track impact, performance, and progress. 101 These requests would be in addition to the reporting requirements outlined in Appendix 1 of 102 Attachment A – SOO. These updates and reports will be considered confidential and shared 103 on a need-to-know basis within USG. 104

Foreign-Owned Interests 105

The CMF shall ensure that no foreign investment capital/interests from USG-prohibited 106 sources list of embargoed and sanctioned countries, as defined by U.S. Departments of 107 Treasury and Commerce, are utilized by the CMF. See also the Foreign Ownership, Control, or 108 Influence (FOCI) Plan requirement included in Appendix 1 of Attachment A - SOO. 109

VI. PROPOSAL PREPARATION AND SUBMISSION INSTRUCTIONS 111

All submissions will be kept confidential and will be reviewed pursuant to established criteria. 112

Respondents are encouraged to register in the System for Award Management (SAM). (NAICS: 113 325414) Registration can be completed here: https://www.sam.gov/. 114

Respondents should submit all documents required to respond to this solicitation via email to 115 shane.sarchiapone@hhs.gov no later than August 22, 2023, at 3:00 PM Eastern. 116

All submissions should consist of a narrative (including figures, schematics, diagrams, graphics, 117 etc., which must be labeled) that describes the organization’s relevant experience, and 118 approach, for performing the Objectives and Requirements outlined in Attachment A – SOO as 119 well as its capabilities in accordance with the Proposal Structure below. 120

8 See 42 U.S.C. 247d-7e(c)(4)(B) https://www.sam.gov/ mailto:shane.sarchiapone@hhs.gov

Notice of Intent 122

1. Respondent is encouraged to notify BARDA, via email, of their intent to submit a 123 proposed approach to the BioMaP-Consortium requirement and include the name of 124 the Respondent as well as prospective organizations with whom the Respondent may 125 partner with as a subcontractor or consultant who will be participating in the decision 126 making or has decision authority. Notices of intent should be sent to 127 shane.sarchiapone@hhs.gov by 5:00 PM Eastern on August 10, 2023. 128

Proposal Structure 130

Overview 131

Please structure proposals in accordance with the sections below. 132

1. Relevant Experience 134

The Respondent should include detailed examples of its relevant current and past 135 organizational experience in accordance with Section VIII – Minimum Eligibility Criteria of this 136 solicitation. 137

2. Key Personnel 139

Provide the following for each key personnel (including key subcontractors, consultants, 140 etc.) who will be responsible for the management and operations of the consortium 141 highlighting those with decision authority. There should be dedicated key personnel to 142 focus areas and provide the following information: 143

a. Name 144

b. Description of role and contribution 145

c. CV/Resume (attached as appendix) 146

Provide specific roles, duties, and the proposed level of effort (as a percentage of full-time 147 employment, as necessary) proposed for listed personnel and denoted on an organizational 148 chart. 149

3. Organizational Capabilities and Consortium Management 151

Respondent should, at minimum, address the following regarding their plan to establish a 152

BioMaP-Consortium and manage their partnership with BARDA and the Consortium Members: 153

a) Respondent should provide an overview of its capabilities to operate a 154 consortium. If the Respondent does not currently have all necessary capabilities, 155 describe, and illustrate how the Respondent plans to scale operations to support 156 Government objectives. 157

b) Describe how they will manage a partnership with BARDA, including discussion 158 of how the Executive Steering Committee (ESC) will be integrated. The 159 Respondent should outline all aspects of the partnership. Describe Respondent’s 160 vision of how BARDA and the Respondent will work together to meet the 161 program’s objectives as described in the SOO (Attachment A). 162

c) Describe the strategy and approach for managing Consortium Members and 163 Project Agreement/Sub-Agreement Holders. This should include discussion of 164 recurring meetings, reporting schedules, program management reviews, and 165 plans for standardizing and compiling deliverables. This should also include a 166 draft Industry Engagement and Communication Plan, as described in Section X - 167 Draft Deliverable and Reporting Requirements. 168

d) Outline the ability to respond rapidly to BARDA requirements, issue solicitations to 169 consortium members and administer executed Project Agreements/Sub-170 Agreements. This should delineate between what the plan for services will be when 171 a PHE is not declared and how, if requested, surge capabilities could be provided. 172

e) Outline and identify parameters that would be used for gauging strategic and key 173 performance indicators for the partnership with description of how the 174 Respondent will define, track, and report on BARDA mission-related impact 175 metrics. 176

f) Demonstrate the ability to maintain daily operations at a high-performance level 177 should managers or key personnel leave the organization. Respondent should 178 submit (with organizational charts) a continuity plan or provide existing operating 179 practices to ensure continuity in the event of turnover as part of the Industry 180 Engagement and Communication Plan, described in Section X – Draft Deliverables 181 and Reporting Requirements. 182

g) Describe operational processes including consortium governance, financial 183 management of the CMF and Project Agreements/Sub-Agreements. 184

h) Provide specific details on how Respondent plans to manage and account for funds 185 awarded by BARDA. 186

i) Provide a detailed description of how the Respondent will protect against conflicts 187 of interest for itself and its subsidiaries, subcontractors, consultants, and advisors. 188 As a condition of any agreement with a CMF as a result of this solicitation, the CMF 189 will be expected to implement and maintain a comprehensive set of policies to 190 address potential conflicts of interest, ethics, and disclosures that are agreed upon 191 by both the USG and the CMF. 192

Please submit all pages as a single, searchable (.doc or .pdf) file. 193

4. Expenditure/Price Proposal 194

The Expenditure/Price Proposal shall be provided in Excel (.xlsx or .xls)) and PDF and should 195 detail: (1) all the activities included in the expenditure structure for the establishment activities 196 and (2) general description of the activities the fee/rate will cover for subsequent Project 197 Agreements/Sub-Agreements placed with Consortium Members for future activities. This 198 narrative response should also illustrate your understanding of the appropriate labor mix to 199 appropriately manage the partnership. 200

It is currently anticipated that the pricing structure for this Agreement will consist of a fixed price 201 award. However, respondents are encouraged to propose creative pricing structures that would 202 incentivize efficient performance and represent value to the USG. Separately, the Government 203 currently anticipates executing subsequent cost-share Project Agreements/Sub-Agreements. 204 BARDA will also consider the use of expenditure-based Project Agreements/Sub-Agreements, if 205 proposed. Note any proposed fee may be a rate based on volume, complexity, type or length of 206 individual Project Agreements/Sub-Agreements; however, it is not the Government’s intent to 207 award a fee structure based on a percentage rate of only the dollar value of individual Project 208 Agreements/Sub-Agreements executed to consortium members. Respondents are encouraged 209 to propose creative fee structures or schedules that would incentivize efficient performance and 210 represent value to the USG. Proposed rates based on volume/complexity of solicitations 211 facilitated by the consortium would be considered as well as minimum fee amounts, as 212 appropriate. All payment structures will be considered. 213

All proposal information in response to this solicitation is submitted at no cost or obligation 214 to the Government. Interested parties are responsible for adequately marking proprietary or 215 competition-sensitive information contained in their response. 216

VII. QUESTIONS 218

Please submit all questions to shane.sarchiapone@hhs.gov by 3:00 PM Eastern on August 7, 219 2023. All questions submitted and accompanying answers may be made public. All answers 220 will be anonymized and contain no identifying information. Do NOT SUBMIT PROPRIETARY 221 INFORMATION. All information received will be assumed to be non-proprietary. 222

VIII. EVALUATION CRITERIA 224

Minimum Eligibility Requirements 225

Each proposal received will be reviewed by BARDA against the minimum eligibility 226 requirements. All respondents must meet the minimum eligibility requirements. Any 227 respondent who does not satisfy this eligibility requirement will not be evaluated and 228 will not be considered for award. The respondent will be notified of the decision. 229

In order to be eligible for evaluation and award, each respondent must meet the following 230 minimum criteria: 231 Must possess direct business experience in the following: 233

1. Initiating and operating a Government-sponsored consortium that successfully 234 identified qualified and technically relevant business partners/technical performers 235 and integrated these partners/performers as consortium members. 236

AND 237

2. Successfully executed and managed subordinate contracts and/or other acquisition 238 instruments to consortium members to achieve Government-sponsored objectives, 239 from solicitation, through award and execution. 240

Submissions must meet the Minimum Eligibility Requirements. Those eligible submissions 241 will then be evaluated against two (2) evaluation factors: 242

• Factor 1: Technical Capability (Adjectival Rating and Performance Confidence Rating) 244

• Factor 2: Expenditure/Price (Based on reasonableness and will not be subject to 246 adjectival ratings) 247

Factor 1: Technical Capability (Adjectival Rating and Performance Confidence Rating) 249

• Factor 1 Technical Capability (Adjectival Rating) definitions: All proposals that meet the 251

Minimum Eligibility Requirements will be assigned an Adjectival Rating, based on the 252 consensus-established strengths, weaknesses and/or insufficiencies described below: 253

Adjectival Rating Description

Outstanding Proposal indicates an exceptional approach and understanding of the requirements and contains multiple strengths.

Satisfactory Proposal has demonstrated an adequate approach and understanding of the requirements.

Unsatisfactory

Proposal does not meet requirements of the solicitation and, thus, contains one or more insufficiencies and is un-awardable. The proposal fails to describe how the Respondent will satisfy the requirements of the solicitation.

• Factor 1 Technical Capability (Performance Confidence Rating): All proposals that meet 256 the Minimum Eligibility Requirements will be assigned a Performance Confidence 257 Rating, based on the consensus-established strengths, weaknesses and/or 258 insufficiencies described below: 259

Performance

Confidence Rating Description

High Strengths outweigh weaknesses and/or insufficiencies. Confidence in successful program execution is high.

Low Weaknesses and/or insufficiencies outweigh strengths. Confidence in successful program execution is low.

No Confidence There is no confidence in successful program execution.

• Factor 1 Technical Capability will be evaluated as follows: Each proposal will be 262 evaluated on the strengths, weaknesses and/or insufficiencies addressing elements 263 including but not limited to those described below. Technical Capability elements are as 264 follows: 265 o Demonstration of a thorough understanding of the program objectives described 267 in the SOO. 268 o Demonstrated ability to establish, govern, and manage the consortium to achieve 269

USG objectives. 270 o Description and viability of a plan for consortium members to easily and 271 seamlessly enter and exit the program. 272 o Description and viability of the respondent’s plan to quickly achieve a state of 273 readiness to engage with and secure industry participation, execution of the 274 process to solicit, award and manage up to 3 Project Agreements/Sub-Agreements 275 within 90 days of award of this Agreement in accordance with the objectives of the 276 SOO, and periodically thereafter. 277 o Description and viability of a plan to manage the intellectual property, data and 278 information between Consortium members and between the Consortium and the 279

USG. 280

o Description and viability of the approach to manage and execute multiple 281 simultaneous subordinate Project Agreements/Sub-Agreements with Consortium 282 members. 283 o Description and viability of the respondent’s Industry Engagement and 284 Communications Plan to enable the respondent to act as the primary liaison 285 between relevant organizations in the biopharmaceutical manufacturing industry, 286 Consortium Members, and the USG. 287 o Thoroughness of the respondent’s approach to establish and maintain a Project 288 Status Dashboard of all consortium OTAs and activities, for use by the USG and 289 Consortium, and establish a consortium website. 290 o Thoroughness and viability of the respondent’s proposed approach to establish 291 and maintain a Master Schedule of all Consortium Project Agreements/Sub-292 Agreements, including all pre and post award milestones and decision events. 293 o Description and viability of the respondent’s approach to financial management, 294 oversight, and invoice management of Project Agreements/Sub-Agreements and 295 other sources of program income (e.g., Consortium membership fees). 296 o Description and viability of the respondent’s approach to Recruitment and 297 Retention of consortium members. 298 o Description and viability of the respondent’s draft Risk Management Plan and Risk 299 Register to track, manage and mitigate program and Project Agreement/Sub-300 Agreement risks, including minimization of performance and supply disruptions 301 during a PHE. 302 o The extent to which the credentials and qualifications of key personnel support the 303 proposed approach, and suitability of the key personnel to the proposed assigned 304 roles and responsibilities. 305 o The extent to which respondent-submitted relevant experience are similar in nature, 306 scope and magnitude to this requirement. The Government may also independently 307 obtain past performance information and will assess the extent to which past 308 performance records indicate predominantly positive performance on prior efforts. 309 o Relevant Experience (Evaluated as part of Factor 1: Technical Capability): 311 o The respondent shall provide at least one (1) and no more than five (5) 313 current and/or previous performance examples. Relevant performance shall 314 include the respondent’s experience as a CMF with total annual obligations 315 of $100M dollars or more. The respondent shall describe how their CMF 316 experience translates in relevance to this requirement. 317 o Each past performance experience shall be for performance within the past 5 319 years, provided in the following format and limited to three pages. The 320 Government reserves the right to contact customer references to verify 321 performance and assess quality of that performance, and to perform 322 independent relevant performance analysis. 323

Respondent’s Name and Contract/Example Name

Contract Number: Contract Type

Period of Performance:

Contract Value

(Base and Sub-awards)

Agency: Customer Points of Contact

Name & Address of Contracting Organization:

Project Officer

Phone

E-mail

Contracting Officer

Phone

E-mail

Similarities to this Solicitation

Brief Description of Project Scope and Customer Expectations

Brief Description of Approach and Performance (include number of consortium members managed per year)

Factor 2 Expenditure/Price: 327 Expenditure/price will be evaluated by personnel from the USG Contracting Office to determine 329 expenditure/price reasonableness. This will be performed through an analysis of the 330 respondent’s proposed expenditures and prices including individual expenditure/price 331 elements (including but not limited to labor categories, labor rates, equipment, travel, indirect 332 rates, etc.). 333

IX. AWARD DECISION 337

BARDA expects to make a single award to a Respondent who presents the most advantageous 338 solution to the USG in accomplishing its program objectives. Each proposal will be evaluated 339 on its individual merit. BARDA reserves the right to engage with any of the Respondents (in-340 person or via teleconference), as necessary, as part of this decision process. 341

Following the evaluation, the Respondent(s) whose submission(s) appears to offer the most 342 advantageous solution(s) to the USG will be invited to enter negotiations with intent to reach 343 and execute an Agreement. Through this process, if it is determined that the Respondent does 344 not offer the most advantageous solution to the USG or mutual agreement on the terms 345 cannot be reached, another Respondent may be invited to enter negotiations. BARDA reserves 346 the right to remove a Respondent from consideration or decide to not issue an award from 347 this announcement. BARDA also reserves the right to make an award without negotiations. 348 Those Respondents not selected for award will be notified of the decision, but formal 349 debriefings will not be offered. 350

X. DRAFT Deliverables and Reporting Requirements 352

Please reference Attachment A – SOO for the complete list of Appendix 1 – Deliverables and 353 Reporting Requirements. 354

Please be aware that the following DRAFT deliverable/reporting requirements will need to be 355 submitted with your proposal. 356

Deliverable Description

Content Requirements and Instructions

Submit Draft with Proposal

(Y/N)

Post Award Reporting Frequency i

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

Yes

Final IMS due 120 days after award.

Updated monthly to be included as part of the monthly progress report.

Format requested: Microsoft Project.

Deliverable Description

Content Requirements and Instructions

Submit Draft with Proposal

(Y/N)

Post Award Reporting Frequency i granular but shall show the major milestones through completion of the effort.

The IMS shall also contain, but not limited to:

• Consortium Milestones and major events (e.g., industry days, website launch, etc.) that cover the full scope of the OT award.

• Project agreement/Sub- Agreement tasks and timelines for new and ongoing projects awarded. Shall include at a minimum:

o Solicitation finalized o Solicitation released o Evaluations o Award

Consortium Establishment & Governance Plan

CMF to provide a detailed plan for how the BioMaP- Consortium will be established and governed. The plan should include the processes, strategy, and tools the CMF will use to ensure successful implementation and governance of the BioMaP Consortium.

The CMF must also include a “Responsible, Accountable, Consulted Informed (RACI)/Study Responsibility Matrix” outlining responsibilities for key activities and deliverables (specific roles for USG, the

Yes Final submission 120 days post-award.

Updated annually.

Content Requirements and Instructions

Submit Draft with Proposal

(Y/N)

Post Award Reporting Frequency i

CMF, and Members will be established at the time of each Project Agreement/Sub- Agreement award) as part of this Plan.

The Consortium Establishment & Governance Plan must also include the CMF’s plan to release solicitations, the processes to make awards, and manage up to 3 Project Agreements/Sub-Agreements within 90 days of Base Agreement OT.

Risk Management Plan

CMF to provide a plan of their processes for risk identification, risk assessment, risk tolerances, mitigation, monitoring and reporting.

The Risk Management Plan will include how the CMF will track, monitor, report and engage with performers concerning risks at the Project Agreements/Sub-Agreements level.

Yes Final submission 120 days post-award.

Updated annually.

Industry Engagement and Communication Plan

Details the communication framework, processes, strategy of engagement, and tools the CMF, the Executive Steering Committee, and consortium members will use for internal and external communications.

Includes the Consortium Membership recruitment and retention plan which details how the CMF will continuously

Yes Final submission 120 days post-award.

Updated annually.

Content Requirements and Instructions

Submit Draft with Proposal

(Y/N)

Post Award Reporting Frequency i and proactively engage with potential and prospective members to elicit participation interest in BioMaP- Consortium, based on objectives provided by BioMaP

Consortium Project Status Dashboard

The CMF will provide and manage an online dashboard, developed in conjunction, and shared with the USG that contains robust metrics for analysis of Project Agreement/Sub-Agreement performances.

Yes Dashboard must be live within the first 90 days post-award.

Updated regularly to ongoing reflect projects’ status.