Attachment A - Statement of Objectives_07.31.23.pdf

BioMaP-Consortium, Consortium Management Firm (CMF) 2

Statement of Objectives (SOO) 3

1. Background 5

The ability of the United States Government (USG) to develop, procure, and secure access to 6 critical medical technologies, products, and supplies is interlinked with national, health, and 7 economic security interests. The USG is heavily dependent upon the private sector for 8 biopharmaceutical R&D, including medical countermeasure (MCM) development, to protect these 9 security interests and ensure that the nation can mitigate the threat of biological incidents. The 10 mission of the Department of Health and Human Services (HHS) Administration for Strategic 11 Preparedness and Response (ASPR) Biomedical Advanced Research and Development 12 Authority (BARDA) is ‘to develop and procure needed medical countermeasures, including 13 vaccines, therapeutics, diagnostics, and non-pharmaceutical countermeasures, against a broad 14 array of public health threats, whether natural or intentional in origin’.1 BARDA was created to 15 address gaps in USG medical countermeasure development, principally by ensuring strong 16 partnerships with, and incentives for, private sector actors involved in the manufacturing of these 17 critical medical products and supplies. 18

Since 20122, BARDA has created these partnerships, in part, through Centers for Innovation in 19 Advanced Development and Manufacturing (CIADMs), aimed at engaging industry partners to 20 provide expertise and infrastructure to develop and manufacture medical countermeasures such 21 as vaccines and therapeutics to respond to public health emergencies (PHE). As the USG looks 22 to strengthen preparedness and response capabilities for future pandemics, BARDA finds itself at 23 a critical inflection point to re-envision and transform the way government interfaces and partners 24 with the private sector to achieve its mission. 25

This contracting action will help expand the industrial and manufacturing base for medical 26 countermeasures during crises and inter-crises, to include the requisite capabilities, flexibilities, 27 and strategies to secure needed medical supplies to meet the nation’s public health 28 preparedness and response requirements. This work aligns with several stated USG objectives in 29 the realm of pandemic preparedness, the bio-preparedness, and public health industrial base, 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/ 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/

BioMaP-Consortium, Consortium Management Firm (CMF) SOO including the American Pandemic Preparedness Plan (referred to as AP3)3, Executive Order 31 138064, Executive Order 140015, and Executive Order 140176. 32

A major component to improving preparedness and response is the formation of the 33 Biopharmaceutical Manufacturing Preparedness Consortium (BioMaP-Consortium) supported by 34 the Pharmaceutical Countermeasure Infrastructure (PCI) Division and Biopharmaceutical 35 Manufacturing Preparedness (BioMaP) Branch of BARDA. The envisioned consortium will 36 comprise industry partners across the drug and vaccine manufacturing supply chain, including 37 the manufacturers of required raw materials and consumables, and suppliers of fill-finish 38 services. 39

The utilization of third-party, professional Consortium Management Firms (CMF) has proven to 40 be an effective strategy for managing consortia implemented by other Federal agencies. As such, 41 BARDA has a specific need to establish an agreement, through BARDA’s Other Transaction 42 Authority (OTA), with a (CMF). 43

This new vehicle will be leveraged to support future BARDA acquisitions, as BARDA implements 44 new programs in alignment with National (e.g., National Biodefense Strategy, American 45 Pandemic Preparedness Plan [APPP]) and HHS strategies (e.g., ASPR Strategic Plan for 2022-46 2026, BARDA Strategic Plan, HHS Pandemic Influenza Plan 2017 Update), subject to 47 appropriations and need. 48

2. Objective 49

BARDA’s primary objective is to establish an agreement with a CMF tasked to establish the 50 BioMaP-Consortium and engage in the overall day to day management of the BioMaP-51 Consortium under the guidance of the BioMaP Branch of BARDA. The CMF will participate in and 52 manage all technical, programmatic, reporting, financial, and administrative matters pertaining to 53 the BioMaP-Consortium. The CMF will also solicit, award, and manage Project Agreements/Sub-54 Agreements to consortium members. 55

3. Requirements 56

3.1. General 57

The CMF will establish and manage a consortium (the BioMaP-Consortium) of 58 pharmaceutical, medical, academic, and scientific organizations working toward 59 successful development and delivery of medical countermeasure materials and products. 60 The CMF will create cooperative partnerships with participating members to ensure that 61

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.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/ there are adequate manufacturing capabilities to provide and make available requisite 62 products and materials, so that countermeasures and therapies can be delivered to civilian 63 populations addressing threats to the nation’s public health or other security interests. 64

BARDA’s Roles and Responsibilities: 65

• Provide funding to the CMF and/or to Consortium Members managed or coordinated by 66 the CMF. 67

• Share pertinent information related to the performance of the CMF between USG agencies 68 on a regular basis. 69

• Review, evaluate, and approve requests from the CMF to add prospective members to the 70 consortium. 71

• Evaluate proposals for prospective Project Agreements/Sub-Agreements to Consortium 72

Members, manage post award services, and participate in all technical meetings and all 73 regulatory meetings to include those with FDA. 74

• Review technical reports and deliverables provided by Consortium Members through the 75 CMF, consistent with the Deliverable list (Appendix 1). 76

• Identify and release strategic priorities to the CMF on an annual basis, or as otherwise 77 directed, that identify focus areas and potential technology types to address identified 78 gaps in strategy. 79

• Provide new and emerging requirements for biopharmaceutical manufacturing resulting 80 from events impacting the evolving BARDA mission space, to include outbreaks, 81 pandemics, and public health emergencies. Such requirements may span the continuum 82 of advanced manufacturing of biopharmaceuticals, from raw materials and manufacturing 83 supplies through fill/finish, packaging, delivery, and administration. 84

3.2. Establishment & Governance of the BioMaP-Consortium 86

The CMF shall develop and execute an establishment approach for the BioMaP-87 Consortium. This establishment approach should create the basic framework for the 88 BioMaP-Consortium with sufficient staffing to enable member recruitment and public 89 outreach. Additionally, the CMF must be ready to execute the process to solicit, award 90 and manage up to three (3) Project Agreements/Sub-Agreements within 90 days of the 91 Base Agreement OTA. Initial membership of the BioMaP-Consortium should be 92 targeted at performers with capabilities that align with the 3 Key Domain areas (Sec. 93 3.2.3). Potential membership of performers with capabilities outside of these domains 94 may be considered after the initial 90 days of the Base Agreement OTA. 95

3.2.1. The CMF shall make Project Agreements/Sub-Agreements within 60 days of a 97 prospective project proposal being provided to the CMF, after the CMF has established 98 the BioMaP-Consortium and achieved readiness at 90 days post award. A 60-day 99 duration shall be the timeline from the CMF’s receipt of a prospective project to Project 100 Agreement/Sub-Agreement award when a public health emergency is not declared. 101

3.2.2. The CMF shall establish and manage the BioMaP-Consortium to meet BARDA 103 objectives. 104

3.2.3. Promote to industry partners and potential consortium members the BioMaP-106 Consortium’s 3 Key Domain areas: 107

1. Industrial Base Expansion of Biomanufacturing Supply Chain – Engage with 108 the network of organizations and personnel that provide all goods and services in 109 support of the entire biomanufacturing process, to include, but not limited to, raw 110 materials, consumables, and fill-finish services. 111

2. Biomanufacturing Capacity Expansion and Reservation - Prepare and provide 112 timely, integrated, and sufficient medical countermeasures in response to emerging 113 pathogens with pandemic potential through establishing, expanding and/or 114 reserving drug substance and/or drug product manufacturing capacities. 115

3. Advanced Biomanufacturing Technologies – Address new and emerging 116 technologies, that enhance existing capabilities that increase the speed, quality, 117 safety, yield, efficiency of the biomanufacturing process or the safety, quality, 118 effectiveness, or availability of the resulting biopharmaceutical drug product. 119

3.2.4. The CMF shall manage, assess, and report on an ongoing basis, the landscape of the 121 biotech/pharmaceutical industry as it pertains to the objectives of the BioMaP-122 Consortium. 123

3.2.5. The CMF shall develop and operationalize a database of capabilities spanning the 3 125 Key Domain Areas described above within 120 days post-award. 126

3.2.6. The CMF shall establish consortium governance rules, membership requirements, 128 bylaws, and organizational structure to achieve BioMaP objectives. 129

3.2.7. The CMF shall form and manage, in conjunction with BARDA, a BioMaP-Consortium 131 Executive Steering Committee (ESC) within 90 days of award. Representation on the 132 BioMaP-Consortium ESC will be drawn from consortium member organizations, as well 133 as ex officio representation from the CMF and HHS BARDA. 134

The ESC will serve a vital role in Consortium governance by setting policy on 135 Consortium operations, examining, and improving Consortium best practices, 136 adjudicating disagreements, and addressing intra-consortium issues. USG participation 137 in the BioMaP-Consortium ESC will be as non-voting members. 138

The CMF shall hold a kickoff meeting of the ESC following its formation. The ESC will 139 meet quarterly virtually and in-person at least once a year. The CMF will prepare a 140 high-level agenda to which the BARDA team will add input for discussion. 141

3.2.8. The CMF shall use safeguards against the disclosure of competitively sensitive 142 information and, together with the ESC, institute antitrust compliance policies and 143 procedures for the BioMaP-Consortium. 144

3.2.9. Together with the ESC, the CMF shall take appropriate steps to avoid organizational 146 conflicts of interest among the Members and to mitigate such conflicts if they cannot be 147 avoided. 148

3.2.10. The CMF and ESC shall work together to establish an Executive Director position for 150 the ESC. 151

3.2.11. The CMF shall establish a website for the BioMaP-Consortium within 120 days post-153 award. 154

The BioMaP-Consortium website must include, but not limited to: 155

• Description of the BioMaP-Consortium, the BioMaP-Consortium mission space, and 156 objectives 157

• Membership page including elements such as how to join BioMaP-Consortium, 158 current members list, and member resources 159

• Solicitations/Funding page to include information about BioMaP-Consortium 160 solicitations, active solicitations, upcoming solicitations, and awards 161

• Page(s) for news, events & announcements 162

• Resources page for governing documents, templates, references, etc. 163

• A function to allow for current and prospective members to contact the CMF 164

• All of the necessary securities and restrictions to protect member information and 165 ensure user access is appropriately limited 166

3.2.12. The CMF shall establish a Data Management & Integration Plan to ensure that the 168 BARDA and CMF systems are interoperable and secure. The data management plan 169 will address the database housing BioMaP-Consortium data and consider the security, 170 organizational needs, and protection of sensitive information. The data integration plan 171 will address how the data is shared between the CMF and BARDA. The integration 172 plan will include timelines, dependencies, assumptions, and web/mobile access with 173 user access restrictions. 174

The Data Management & Integration Plan must be provided within the first 90 days 176 post-award. 177

3.2.13. The CMF shall develop the Articles of Collaboration for the BioMaP-Consortium. The 179

Articles of Collaboration must be provided within 60 days of OT Agreement award. See 180 Appendix 1. 181

3.3. Industry Engagement 183

3.3.1. The CMF shall maintain and execute a Consortium Membership recruitment and 184 retention plan. The retention plan should include actions to continuously and 185 proactively engage with potential and prospective members to elicit participation 186 interest in BioMaP-Consortium, based on objectives provided by BioMaP. This must be 187 included as part of the Industry Engagement and Communications Plan. See Appendix 188

1. 189

3.3.2. The CMF shall ensure that all joining members are informed that Project 191 Agreements/Sub-Agreements awarded under the BioMaP-Consortium will be restricted 192 to domestic (U.S.) investments. 193

3.3.3. The CMF shall utilize its subject matter experts to evaluate prospective respondents’ 195 credentials to do business with BARDA and provide evidence of technical capabilities 196 to ensure relevance and appropriateness to the BioMaP-Consortium. 197

3.3.4. The CMF shall identify and recruit members to establish a robust collective of 199 companies/institutions from across the biopharmaceutical manufacturing and 200 development enterprise, to include industry partners across the drug and vaccine 201 manufacturing supply chain, manufacturers of required raw materials and 202 consumables, and suppliers of fill-finish services. BioMaP-Consortium membership is 203 not restricted to U.S.-based companies/institutions. 204

3.3.5. The CMF shall ensure that any consortium member application and/or membership 206 fees are nominal, and membership shall be open and unrestricted for any organization, 207 academic institution, and/or local and regional government agencies with an interest in 208 BioMaP-Consortium participation. 209

3.3.6. The CMF shall facilitate teaming among members to ensure innovative solutions and 211 sound capabilities. 212

3.3.7. The CMF shall provide training and onboarding support to new consortium members. 214

3.3.8. The CMF shall conduct BioMaP-Consortium industry days, hosted in the Washington, 216 D.C. metro area on an annual basis or a frequency determined by the Agreements 217

Officer. Travel and other associated costs to consortium members for participating in 218 BioMaP-Consortium industry days will not be reimbursed by the USG. 219

3.4. Solicitations & Awards of Project Agreements/Sub-Agreements 221

3.4.1. The CMF shall develop and manage a solicitation structure and proposal process, to 222 include a capture and proposal management system for the BioMaP-Consortium. 223

3.4.2. The CMF shall assist in the preparation and issuance of solicitations to Consortium 225 Members based on technical requirements and source selection procedures provided 226 by the USG. Solicitations will be competitive to the maximum extent practicable. 227

3.4.3. The CMF shall provide administrative support to streamline the proposal review 229 process through curation, summarization, compilation, compliance checks, and other 230 methods to enable prompt USG technical evaluation and source selection. 231

3.4.4. The CMF shall provide administrative support in negotiations with the USG on issues 233 involving Project Agreements/Sub-Agreements or other contractual documents. 234

3.4.5. The CMF shall issue Project Agreements/Sub-Agreements to approved Consortium 236 Members based on USG decisions and recommendations within 90 days of a 237 solicitation release (during non-PHE). 238

3.4.6. The CMF shall ensure that all awards of Project Agreements/Sub-Agreements to 240

Consortium Members comply with all current applicable laws and regulations. These 241 may include flow-down requirements identified by the USG. 242

3.4.7. The CMF shall provide administrative oversight of all Consortium Members performing 244 under an awarded Project Agreements/Sub-Agreements, to include the following 245 actions: 246

3.4.7.1. Provide and manage an online dashboard, developed in conjunction, and 248 shared with the USG that contains robust metrics for analysis of Project 249 Agreement/Sub-Agreement performances. A draft of the dashboard must be 250 submitted within the first 90 days post-award. 251

3.4.7.2. Collect any consortium member dispute information and coordinate disputes with 253

USG. 254

3.4.7.3. Support adjudication as applicable in support of USG for disputes relating to 256 technical performance guidance provided by USG, or other disputes. 257

3.4.7.4. Proactive and timely resolve disputes between Consortium Members and the 259

CMF for which the USG is not a participant. 260

3.4.7.5. The CMF shall perform close-out of Project Agreements/Sub-Agreements. 262

3.5. Finance & Accounting 264

3.5.1. The CMF must demonstrate the ability to maintain an accounting system that can track 265 the expenditures of USG funds and investments of those funds. 266

3.5.2. The CMF must participate, as required, with the USG in the planning, programming, 268 and budgeting of the projects. 269

3.5.3. The CMF shall manage funds from the USG relating to issuing of Project 271

Agreements/Sub-Agreements and payment of Consortium Member invoices. 272

3.5.4. The CMF shall manage the accounting of all funds received from the USG and 274 maintain enough monies to promptly pay all invoices due to the members. 275

3.5.5. Ensure that BioMaP-Consortium members are promptly paid for all invoices submitted. 277

3.5.6. Ensure that the resources available to the members will cover the costs within the year 279 of execution. Promptly notify the USG if/when funds are going to run out on any given 280 Project Agreement/Sub-Agreement that is being executed. 281

3.5.7. The CMF shall review and validate all invoices. 283

3.6. During a PHE, as declared by the Secretary of HHS 285

3.6.1. The CMF shall rapidly execute Project Agreements/Sub-Agreements in as little as five 287

(5) calendar days (from release of the requirement to award). 288

3.6.2. The CMF must have the ability to provide surge support (e.g., extended business 290 hours, additional staff, etc.) during a response phase of a pandemic or other PHE. 291

3.6.3. The CMF shall maintain all functionality, communications, and operations of the 293 consortium, to include monitoring performance of Consortium Members executing 294 awarded Project Agreements/Sub-Agreements, during a public health emergency. 295

3.7. Program Management 297

3.7.1. The CMF shall establish and maintain an efficient and effective organization to oversee 299 the BioMaP-Consortium and its members, solicitations and awards, execution of 300 programs, financial management of contract resources, attracting and maintaining 301 consortium members, and consortium promotion. 302

3.7.2. Provide technical and administrative infrastructure to ensure the efficient planning, 304 initiation, implementation, and direction of all agreement activities. 305

3.7.3. The CMF shall develop a Project Management Plan that describes the relationships, 307 accountabilities, communications, and oversight of coordination of the collaborative 308 activities of the CMF as well as the USG and the Consortium Members during 309 planning, start-up, execution, and close-out. 310

3.7.4. The CMF shall develop an Industry Engagement and Communication Plan that details 312 the communication framework, processes, strategy of engagement, and tools the CMF, 313 the Executive Committee, and consortium members will use for internal and external 314 communications. A draft of the Industry Engagement and Communication Plan shall be 315 submitted with the CMF’s proposal and a final draft provided within 120 days of award. 316 See Appendix 1. 317

3.7.5. The CMF shall develop a Public Health Emergency Response/Activation Plan that 319 provides: 320

• Description of how response/activation would be initiated 322

• Decision tree and necessary approvals to activate 323

• Description of raw/material identification processes 324

• Description of manufacturer identification process 325

• Description of plan would be monitored 326

• Description of process to terminate an activity or program to include: 327 o Decision criteria 328 o Decision rational and documentation 329 o Rebuttal process and timeline 330

The Public Health Emergency Response/Activation Plan is to be submitted within 90 331 days post-award. See Appendix 1. 332

3.7.6. The CMF shall develop and maintain a “Responsible, Accountable, Consulted, 334

Informed (RACI)/Study Responsibility Matrix” outlining responsibilities for key activities 335 and deliverables (specific roles for USG, the CMF, and contractor will be established at 336 the time of each Project Agreement/Sub-Agreement award). The RACI Chart/Matrix 337 shall be included as part of the Consortium Establishment & Governance Plan, see 338 Appendix 1. 339

3.7.7. The CMF shall develop and maintain comprehensive timelines in MS Project or a 341 compatible application. See Appendix 1. 342

3.7.8. The CMF shall provide written project status reports according to pre-specified 344 schedules for active Project Agreements/Sub-Agreements. 345

3.7.9. The CMF shall establish project milestones for the effort. The CMF shall ensure that 347 any changes or deviations planned or incurred by the CMF in pursuing the objectives 348 of any resulting agreement are reported to the USG. While primary responsibility for 349 management and execution of the effort resides with the CMF, the USG shall have 350 input to the milestone review process and any changes to the objectives of any 351 resulting agreement. The USG shall have the responsibility for communicating to the 352 CMF any changes in USG MCM strategies that may impact any resulting agreement. 353

3.7.10. Risk Management. The CMF shall identify all anticipated consortium risks and track 355 them via a Risk Register in accordance with the deliverable’s requirement (Appendix 356 1). The CMF shall manage all consortium risks using its in-house risk management 357 capabilities and report to USG any changes to all identified risks as they occur/arise. 358 The CMF shall ensure that the USG is permitted to participate in the risk management 359 and mitigation processes associated with this project. 360

The CMF shall track risks at the individual Project Agreement/Sub-Agreement level, 361 separate from consortium program risks, for each award made through the consortium. 362 The Risk Management Plan should detail how the CMF will track risks and engage 363 performers regarding risks at the Project Agreement/Sub-Agreement level. 364

A Risk Management Plan shall be submitted within 120 days post-award, updated as 365 required. See Appendix 1. 366

3.8. Meetings 368

The CMF and USG shall participate in regular meetings to coordinate and oversee the requirement 369 as requested by the Other Transaction Agreements Officer (OTAO) and/or the Other Transaction 370 Technical Representative (OTTR). Such meetings may include, but are not limited to, site visits to the 371 CMF’s facilities, and meetings with other USG officials to discuss the technical, and regulatory 372 aspects of the program. The CMF shall provide data, reports, and presentations to groups of outside 373 experts and USG personnel and USG-contracted subject matter experts as required by the 374 OTAO/OTTR facilitating review of activities. The CMF shall participate in the following: 375

a. Agreement Initiation Meetings and kick-off 376

b. Monthly Project Team Meetings 377

c. Quarterly In Progress Review 378

d. Ad Hoc Meetings and Teleconferences 379

3.9. Reporting Requirements 381

See Deliverables Table (Appendix 1.) for specific reporting requirements. 382 Performance of the OT will be monitored by the OTAO/OTTR on a regular basis. The 384 OTAO/OTTR will be responsible for inspection and acceptance of deliverables and services. 385 Monitoring of the OT will be based on periodic reporting by the CMF. The first “kick-off” site visit 386 will be convened within 5 days of award to review USG procedures, processes, and 387 expectations, as well as CMF’s data and plans. Qualified USG subject matter experts will 388 perform program assessment. 389

4.0. Deliverables 390

See Appendix 1. 391

5.0. Property 392

No government furnished or acquired property is anticipated to be used in the performance of this 393

OT. 394

6.0. Initial Schedule Objectives 395

The period of performance for this effort is 10 years. 396

• 90 Days Post Award: The CMF for the BioMaP-Consortium must be ready to receive 397 solicitations from the USG, engage in all activities from solicitation to award, and be ready 398 to effectively manage the awarded Project Agreements/Sub-Agreements (up to 3) within 399 90 days of the Base Agreement OT. 400

For additional schedule objectives, see Appendix 1. Deliverables. 401

7.0. Foreign-Owned Interests 402

The CMF shall ensure that no foreign investment capital/interests from USG-prohibited sources 403 (i.e., the current list of embargoed and sanctioned countries as defined by U.S. Departments of 404 Treasury and Commerce) are utilized by the CMF. See also the Foreign Ownership, Control, or 405 Influence (FOCI) Plan requirement included in Appendix 1. 406

APPENDIX 1. Deliverables and Reporting Requirements 407

Deliverable Description Content Requirements and Instructionsi Reporting

Frequencyii,iii Kick Off Meeting

CMF 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 five (5) days of award.

Minutes to be submitted within three (3) business days of meeting.

Ad-hoc Project Team Meetings

CMF to schedule and create and agenda. Follows Agenda mutually agreed upon in advance of meeting. CMF to provide meeting minutes within three (3) business days from date of meeting.

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

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, five (5) business days after the monthly report deliverable. One hour in duration, hosted by the

CMF.

Minutes to be submitted within three (3) business days of meeting.

Monthly Project Progress Report

Monthly report of overall status including but not limited to:

• Program budget o 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.

• Performance (e.g., Milestones reached)

• Schedule progress noting variance from previous month’s report. Include status of project delays, risk management, funding issues.

• Project Action Items (should contain information regarding identification date, target completion, responsible individuals/groups, etc.)

• Consortium Risk Register, pertaining to risks at the consortium level. (should contain information regarding identification date, severity of risk, mitigation plan(s) and dates for implementation, risk owner, etc. Risks no longer in need of tracking should be noted as

Due monthly, 15 days into the month.

CMF 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.

Frequencyii,iii such with end date but retained within risk register file submitted to USG.)

Feedback or revisions are to be incorporated in future reports.

Quarterly In- Process Review (IPR)

Organized, scheduled, and hosted by CMF. May be virtual or physical at the CMF’s facilities based on USG preference. High level project progress review of overall objectives. Updated projections against project expectations, including risks and mitigation plans, shall be presented with respect to the last quarterly.

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

CMF to send slide deck three (3) working days in advance of meeting.

Minutes to be submitted within 3 business days of meeting.

Articles of Collaboration

The agreement to be established between the CMF and the members of the BioMaP-Consortium.

The plan to establish this document is to be developed by the awarded CMF.

The USG anticipates that this document includes elements such as but not limited to:

• Terms and Conditions

• Definitions

• Exit and Entry of Members

• Intellectual Property

• Data rights

Submission of Articles of Collaboration due 60 days after award.

Update as necessary.

Frequencyii,iii 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.

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

Final IMS due 120 days after award.

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

Format requested:

Microsoft Project.

Database of Industry Landscape

The CMF is to develop and operationalize a database of the landscape of the biotechnology and/or pharmaceutical industry as it pertains to the BioMaP-Consortium mission space and targets the 3 Domain Areas.

Manage, assess, and report on an ongoing basis, the landscape of the biotech/pharmaceutical industry.

Initial submission 120 days post-award.

Updated annually.

Frequencyii,iii Consortium Establishmen t & 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 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 90days of Base Agreement

OTA.

Final submission 120

Updated annually.

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.

Updated annually.

Industry Engagement and Communicati on 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 and proactively engage with potential and prospective members to elicit participation interest in BioMaP-Consortium, based on objectives provided by BioMaP

Frequencyii,iii Data Management & Integration Plan

The CMF will prepare a data management and integration plan to ensure that the BARDA and CMF systems are interoperable and secure.

The data management plan will address the database housing the BioMaP-Consortium data, considering security, organizational needs, and protection of sensitive information.

The data integration plan will address how the data are shared between the CMF and BARDA, and will include timelines, dependencies, assumptions, and web/mobile access with user access restrictions.

Initial submission 90

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.

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

Updated regularly to ongoing reflect projects’ status.

Public Health Emergency Response/Ac tivation Plan

CMF will provide an activation plan that allows for a scalable surge capacity (e.g., extended business hours) during a declared public health emergency.

The plan will cover:

• Description of how response/activation would be initiated

• Decision tree and necessary approvals to activate

• Description of raw/material identification processes

• Description of manufacturer identification process

• Description of plan would be monitored

• Description of process to terminate an activity or program to include:

o Decision criteria o Decision rational and documentation o Rebuttal process and timeline

Initial submission 90

Updated annually thereafter.

Frequencyii,iii 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 award. 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 Respondent 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, 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 period of performance. Within 15 days of receipt, the Government will provide review comments. The Respondent 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.

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 Respondent shall respond within 15 days of receipt of comments.

Update as necessary

Frequencyii,iii BioMaP- Consortium website

The BioMaP-Consortium website must include, but not limited to:

• Description of the BioMaP-Consortium, the

BioMaP-Consortium mission space, and objectives

• Membership page including elements such as how to join BioMaP-Consortium, current members list, and member resources

• Solicitations/Funding page to include information about BioMaP-Consortium solicitations, active solicitations, upcoming solicitations, and awards

• Page(s) for news, events & announcements

• Resources page for governing documents, templates, references, etc.

• Allow for current and prospective members to contact the CMF

• All of the necessary securities and restrictions to protect member information and ensure user access is appropriately limited

Within 120 days post-award.

Updated regularly to reflect ongoing BioMaP- Consortium activities.

Security Plan

The Security Plan must detail how the CMF will adhere to established ASPR Informational Technology (IT) and Operational Security (OPSEC) policies and requirements.

The Security Plan must include but is not limited to:

• Internal management security measures that meet the ASPR, IT, and OPSEC security requirements

• Plan to ensure Project Agreement security compliance, to include roles and responsibilities

• Plan to manage Consortium member physical, IT, and OPSEC security compliance as a contingency of Consortium membership

Submission within 90 days post-award, updated as necessary.

See BARDA Security Plan checklist i Unless otherwise specified, CMF’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.

ii 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.

iii All Final Deliverable Submissions are subject to USG review and comment which may result in additional Deliverable submissions by the CMF.