13Oct15_BAA-16-100-SOL-00003_SSTBAA.pdf

Broad Agency Announcement (BAA) for Advanced Research and Development to Expedite the Identification, Development, and Manufacturing of Medical Countermeasures against Infectious Diseases

BAA-16-100-SOL-00003

Biomedical Advanced Research and Development Authority

(BARDA)

330 Independence Avenue, SW, Room G644

Washington, DC 20201

BARDA SST BAA-16-100-SOL-00003 Page 2

Table of Contents

Broad Agency Announcement (BAA) for Advanced Research and Development to Expedite the Identification, Development, and Manufacturing of Medical Countermeasures against Infectious Diseases

INTRODUCTION

OVERVIEW INFORMATION

Agency Name:

Issuing Office:

Development Opportunity Title:

Announcement Type and Date:

Eligible Offerors:

Development Opportunity Description:

Technological Maturity:

Number of Awards:

Type of Award:

Application Process:

Submission Deadlines and Government Response Time(s):

Contact/Submission Information:

Preliminary Inquiries:

TechWatch Program:

Special Instructions:

Proposal Handling and Submission Information:

BACKGROUND

Part I: Development Areas of Interest

Area of Interest #1: Platform Technologies to Expedite the Identification, Development, and Manufacturing of Medical Countermeasures against Infectious Diseases

Part II: R e s e r v e d Part III: Reporting Requirements and Deliverables

Reports:

Meetings:

Regulatory and Quality Management:

Audits / Site Visits:

Program Management Plans and Documentation:

Earned Value Management:

Part IV: Special Considerations A. Contractor Responsibility Regarding Sensitive Information:

B. Security Plan:

C. Identification and Disposition of Data:

D. Confidentiality of Information:

E. Publications:

F. Press Releases:

G. Export control notification:

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H. Manufacturing Standards:

I. Prohibition on contractor Involvement with Terrorist Activities:

J. Invoices:

Part V: Quad Chart/White Paper Instructions (Stage 1) Quad Chart and White Paper Preparation Quad Chart and White Paper Submission Chart and White Paper Review

Part VI: Full Proposal Instructions (Stage 2) Stage 2: Full Proposal Instructions Volume I – Technical Proposal Volume I - Technical Proposal Attachments Volume II – Cost Proposal Volume II - Cost Proposal Attachments

Stage 2: Full Proposal Submission Part VII: Quad Chart/White Paper and Full Proposal Evaluation

A. Quad Chart/White Paper Evaluation Criteria B. Full Proposal Evaluation Criteria C. Other Evaluation Factors and Considerations D. Evaluation Rating E. Additional Information

Part VIII: Attachments Attachment 1: Technology Readiness Level (TRL) Definitions for Medical In-Vitro Diagnostic Devices Attachment 2: Target Product Profile Template Attachment 3: Regulatory Guidance for Devices Attachment 4: Summary of Related Activities

Attachment 5: Quad Chart Format Template Attachment 6: Government Notice for Handling & Submitting Proposals 72 Attachment 7: Breakdown of Proposed Estimated Cost (Plus Fee) and Labor Hours (For Cost Proposal) Attachment 8: Total Life Cycle Costs (TLCC) Definition

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INTRODUCTION

This Broad Agency Announcement (BAA), which sets forth development areas of interest for the Biomedical Advanced Research and Development Authority (BARDA), is issued under paragraph 6.102(d)(2)(i) of the Federal Acquisition Regulation (FAR).

Proposals selected for award are considered to be the result of full and open competition and in full compliance with "The Competition in Contracting Act of 1984" 41 U.S.C. § 253 et seq. A formal Request for Proposal and/or additional information regarding this announcement will not be issued. Paper copies of this announcement will not be issued.

The Government reserves the right to select for award and fund all, some or none of the proposals in response to this announcement. All proposals will be treated as sensitive competitive information and the contents only disclosed for the purpose of evaluation.

Offerors that are not responsive to BARDA requests for information in a timely manner, defined as meeting government deadlines established and communicated with the request, may be removed from award consideration.

The Government reserves the right to award the instrument best suited to the nature of the research proposed and may award any appropriate contract type under the Federal Acquisition Regulation.

OVERVIEW INFORMATION

Agency Name:

Department of Health and Human Services, Office of the Secretary, Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority 330 Independence Avenue, SW, RM G644, Washington, DC, 20201

Issuing Office:

Department of Health and Human Services, Office of the Secretary, Assistant Secretary for Preparedness and Response, Acquisition Management, Contracts & Grants (AMCG), 330 Independence Avenue, SW, RM G644, Washington, DC, 20201

Development Opportunity Title:

Broad Agency Announcement for the Advanced Research and Development to Expedite the Identification, Development, and Manufacturing of Medical Countermeasures against Infectious Diseases

Announcement Type and Date:

Broad Agency Announcement renewal announcement, October 13, 2015 as: BAA-16-

100-SOL-00003

Note: This Broad Agency Announcement is a re-issuance of the following versions which have been re-issued annually:

Initial Announcement as BARDA-BAA-11-100-SOL-00001, issued January 1, 2011 and expired December 31, 2011; and BARDA-BAA-12-100-SOL-00013, issued June 8, 2012

BARDA SST BAA-16-100-SOL-00003 Page 5 and expired June 7, 2013; and SST-BAA-13-100-SOL-00014, issued July 31, 2013 and expired July 30, 2014, and extended on April 2, 2014 to expire on July 30, 2015, and extended on July 28, 2015 to expire on October 31, 2015.

This BAA is available on the following websites:

Federal Business Opportunities - FBO.gov1

MedicalCountermeasures.gov2

Public Health Emergency - PHE.gov3

Grants.gov4

Amendments to this BAA will be posted to the websites listed above when they occur.

Interested parties are encouraged to periodically check these websites for updates and amendments.

Eligible Offerors:

This BAA is open to ALL responsible sources. Offerors may include single entities or teams from private sector organizations, Government laboratories, and academic institutions.

To be eligible for award, a prospective recipient must meet certain minimum standards pertaining to financial resources, ability to comply with the performance schedule, prior record of performance, integrity, organization, experience, operational controls, technical controls, technical skills, facilities, and equipment.

Federally Funded Research and Development Centers (FFRDCs) and Government entities (Government/National laboratories, military educational institutions, etc.) are subject to applicable direct competition limitations and cannot propose to this BAA in any capacity unless they address the following conditions. FFRDCs must clearly demonstrate that the proposed work is not otherwise available from the private sector AND must also provide a letter on letterhead from their sponsoring organization citing the specific authority establishing their eligibility to propose to government solicitations and compete with industry, and compliance with the associated FFRDC sponsor agreement and terms and conditions. This information is required for FFRDCs proposing to be prime or subcontractors. Government entities must clearly demonstrate that the work is not otherwise available from the private sector and provide written documentation citing the specific statutory authority (as well as, where relevant, contractual authority) establishing their ability to propose to Government solicitations.

Specific supporting regulatory guidance, together with evidence of agency approval will be required to fully establish eligibility. BARDA will consider eligibility submissions on a case-by-case basis; however, the burden to prove eligibility for all team members rests solely with the Proposer.

https://www.fbo.gov/ https://www.medicalcountermeasures.gov/ http://www.phe.gov/ http://www.grants.gov/ https://www.fbo.gov/ https://www.medicalcountermeasures.gov/ http://www.phe.gov/ http://www.grants.gov/

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Historically Black Colleges and Universities (HBCU), Minority Institutions (MI), Small Business concerns, Small Disadvantaged Business concerns, Women-Owned Small Business concerns, Veteran-Owned Small Business concerns, Service-Disabled Veteran-Owned Small Business concerns, and HUBZone Small Business concerns are encouraged to submit proposals and to join other entities as team members in submitting proposals.

In accordance with federal statutes, regulations, and HHS policies, no person on grounds of race, color, age, sex, national origin, or disability shall be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any program or activity receiving financial assistance from HHS.

Development Opportunity Description:

The Biomedical Advanced Research and Development Authority solicits the advanced research and development of medical countermeasures for chemical, biological, radiological, and nuclear agents that threaten the U.S. civilian population. BARDA anticipates that research and development activities awarded under this BAA will serve to advance candidate medical countermeasures towards licensure or approval by the Food and Drug Administration (FDA).

The purpose of this BAA is to solicit proposals that focus on one or more of the following solicited areas of interest as listed here and further described in Part I of this announcement.

Development Areas of Interest:

1. Platform Technologies to Expedite the Identification, Development, and Manufacturing of Medical Countermeasures against Infectious Diseases

Efforts proposed by Offerors may include activities in Non-Clinical Research and Development, Process Development, Formulation, and Manufacturing Development, and Clinical Evaluation.

Technological Maturity:

Offerors must identify in their Quad Chart and White Paper the current Technology Readiness Level (TRL) of their product, and the TRL level identified should meet or exceed the requirements of the given Development Area of Interest. Each White Paper should also contain sufficient supporting information to justify the TRL rating. Criteria for determining the appropriate TRL for a product can be found in Attachment 1. Note that all activities within a TRL (or sublevel) must be completed to have achieved that TRL status. One TRL criteria document is provided for use with diagnostics and medical devices (Attachment 1A) and one TRL criteria document is provided for use with therapeutics and vaccines (Attachment 1B).

Number of Awards:

Multiple awards of various values are anticipated and are dependent upon the program priorities, proposals’ scientific/technical merits, how well the proposals fit BARDA’s areas of interest, and available funding. Anticipated funding for the program (not per contract

BARDA SST BAA-16-100-SOL-00003 Page 7 or award) may range from $10M to $50M dollars subject to congressional appropriations. This funding profile is an estimate only and will not be a contractual obligation for funding. All funding is subject to change due to government discretion and funding availability.

Type of Award:

A contract awarded under this BAA may utilize: Cost-Reimbursement, Cost-plus-fixed-fee (CPFF), Cost-plus-incentive-fee (CPIF), Firm fixed price (FFP), or a cost sharing structure. Although cost sharing is not required under this BAA; however, formal or informal cost sharing is encouraged where there is a reasonable probability of a potential commercial application related to the proposed research and development effort.

If the government contemplates the award of a cost type contract, the offeror must demonstrate prior to award that its accounting system is adequate for administering a cost- reimbursement contract. Offerors should propose the type of arrangement they believe best satisfies the requirement.

BARDA may also elect to make awards in the form of grants and cooperative agreements, and Other Transactions (OT) agreements, as authorized for BARDA under the Pandemic and All Hazards Preparedness Reauthorization Act (2013).

The costs of preparing responses to this BAA are not considered an allowable direct charge on any resultant award.

Application Process:

Stage 1: Prepare a cover sheet, Quad Chart, and White Paper in accordance with the preparation guidance. The Quad Chart and White Paper should describe the effort in sufficient detail to allow evaluation of the concept's technical merit and its potential contribution to the BARDA mission. BARDA will evaluate White Papers based on the criteria provided in Part VII.

Offerors whose Quad Chart and White Paper receive a favorable evaluation will be invited by e-mail to submit a Full Proposal. Offerors whose Quad Chart and White Paper did not receive a favorable evaluation will be notified by e-mail, and will be provided with information on technical issues and concerns that BARDA has regarding the proposed product. This written feedback is the only response that will be provided to unsuccessful Stage 1 Offerors.

Stage 2: Offerors must submit their Full Proposals in accordance with the instructions provided Part VI. Full Proposals will be evaluated against criteria as described in Part VII. Proposals that do not conform to the requirements outlined in the BAA or to the instructions provided in the invitation letter will not be considered for further action.

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Submission Deadlines and Government Response Time(s):

Table 1: Submission Deadlines and Government Response Time

Proposal Stage Deadline for Submission* USG Response

Stage 1: Quad Chart and White Paper

A Quad Chart and White Paper may be submitted on any day during the open period of the BAA. Interim deadlines are:

30-Jan-2016 30-Apr-2016 30-Jul-2016 30-Oct-2016 30-Jan-2017 30-Apr-2017 30-Jul-2017 30-Oct-2017

The final White Paper deadline is October 30, 2017.

Receipt confirmation within 1 week.

Decision within 90 calendar days of interim submission deadline

Stage 2: Full Proposal As specified in the invitation Letter

Receipt confirmation within 1 week.

Source Selection Notification (pending availability of funds)

Decision within 180 calendar days of receipt of Full Proposal or final revised proposal.

*Submissions are due each date at 4:30PM EST. Receipts for all White Papers submitted will be sent electronically within one (1) week of submission.

Contact/Submission Information:

All submissions and administrative inquiries regarding this BAA shall be addressed to SST-BAA@hhs.gov.

Technical questions should be directed to the Technical Point of Contacts (POCs) shown following each development areas of interest. These POC’s are located, in “Part I: Development Areas of Interest.” When an inquiry is made, please include all pertinent contact information.

Be advised that after a white paper (or full proposal) has been submitted, all communications related to that submission must be through the BARDA Contracting Office AMCG.

As a white paper is not considered a “proposal,” no debriefing will be provided defined by FAR Subpart 15.5.

Quad Chart and White Papers WILL NOT BE ACCEPTED after 4:30 PM (Eastern Standard Time) on 30 October 2017. The submission deadlines are listed above.

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Preliminary Inquiries:

BARDA realizes that the preparation of a development proposal often represents a substantial investment of time and effort by the Offeror. In an attempt to minimize this burden, BARDA encourages organizations and individuals interested in submitting development proposals to make preliminary inquiries as to the general need for the type of development effort contemplated before expending extensive effort in preparing a detailed development proposal or submitting proprietary information.

Offerors contemplating submitting Quad Charts, White Papers, and Full Proposals are strongly encouraged to contact the appropriate technical Point of Contact (POC) at BARDA (see names and e-mail addresses listed immediately after each development area of interest). Offerors are advised that only a Contracting Officer may obligate the Government to any agreement involving expenditure of Government funds.

TechWatch Program:

Offerors under this BAA are invited to arrange a meeting at BARDA headquarters through the TechWatch program. Participation in the TechWatch program affords offerors an opportunity to present their capabilities to BARDA scientific subject matter experts and program managers, as well as AMCG contract professionals. These personnel can evaluate products/technologies, suggest techniques and strategies for meeting technical and regulatory challenges, provide insight on how a product or technology may address BARDA's objectives, and provide general information about BARDA's mission and programs. To arrange a TechWatch meeting and for more information about the TechWatch program, offerors should visit the TechWatch website5.

Please allow sufficient time for BARDA to schedule a meeting with your organization.

Entities with a white paper or proposal currently under review under any ASPR solicitation are not eligible to schedule a TechWatch meeting related to that submission.

Special Instructions:

Special instructions will be advertised via the BAA as they become apparent. These additional instructions are tailored to a specific area of interest and may have a unique submittal date. The information requested in these instructions should be used along with Part VI of the BAA to format and prepare the Technical and Cost Proposals.

Offerors should follow the instructions in Part VI of the BAA, and include the information requested therein.

Proposal Handling and Submission Information:

Treatment of Submission Documents: All proposals are treated as offeror’s proprietary information prior to award and the contents are disclosed only for the purpose of evaluation. The Offeror must indicate any limitation to be placed on disclosure of information contained in the proposal in accordance with the instructions as set forth by FAR 52.215- 1(e) “Restrictions on disclosure and use of data,” and outlined in the Attachments to this BAA.

CLASSIFIED SUBMISSIONS: Classified proposals will not be accepted. All submissions https://www.medicalcountermeasures.gov/barda/advancing-innovation/techwatch.aspx https://www.medicalcountermeasures.gov/barda/advancing-innovation/techwatch.aspx

BARDA SST BAA-16-100-SOL-00003 Page 10 must be Unclassified.

Use of Color Proposals: All proposals received shall be stored as electronic images.

Electronic color images require a significantly larger amount of storage space than black-and- white images. As a result, Offerors' use of color in proposals should be minimal and used only when absolutely necessary for details. Do not use color unless necessary.

Post-Employment Conflict of Interest: There are certain post-employment restrictions on former federal officers and employees, including special government employees (Section 207 of Title 18, U.S.C.). If a prospective Offeror believes a conflict of interest may exist, the situation should be emailed to the appropriate Contracting Officer, prior to expending time and effort in preparing a proposal. The appropriate HHS personnel will discuss any conflict of interest with prospective Offerors.

Unsuccessful Proposal Disposition: Proposals will not be returned. The original of each proposal received will be retained by ASPR pursuant to FAR 4.805 and all other non-required copies destroyed.

Government Notice for Handling and Submitting Proposals: Refer to Attachment 6 for inclusion requirement of the government notice.

BACKGROUND

This Broad Agency Announcement (BAA) sets forth advanced development areas of interest for the Strategic Science and Technology Division of the Office of the Biomedical Advanced Research and Development Authority (BARDA), a component of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services. This BAA is issued under paragraph 6.102(d)(2) of the Federal Acquisition Regulation (FAR), and proposals selected for award are considered to be the result of full and open competition and in full compliance with The Competition in Contracting Act of 1984, 10 U.S.C.§ 2304.

BARDA is the lead Federal agency for the advanced development of medical countermeasures (MCM) to protect the United States against public health emergency threats, including chemical, biological, radiological and nuclear agents, emerging infectious diseases, and pandemic influenza. The Pandemic and All Hazard Preparedness Reauthorization Act directs BARDA to promote (i) innovations in technologies that may assist MCM advanced research and development, (ii) research and development of tools, devices, and technologies, and (iii) research to promote strategic initiatives, such as rapid diagnostics, broad spectrum antimicrobials, and vaccine manufacturing technologies.

BARDA’s mission to develop and provide countermeasures for CBRN threats, pandemic influenza, and emerging infectious diseases is being addressed by a comprehensive approach of product development, stockpile acquisition/building, and manufacturing infrastructure building. Countermeasures against a wide range of currently known threats have been and are being addressed directly via these programs. A more challenging part of the mission is to be able to respond in a timely fashion to newly

BARDA SST BAA-16-100-SOL-00003 Page 11 emerging infectious diseases, such as Middle East Respiratory Syndrome (MERS) and Ebola. In some cases, existing countermeasures such as broad-spectrum antimicrobials or other drugs may be applied or re-purposed for use against newly identified pathogens. But other countermeasures that work by eliciting protective immunity, either actively or passively, in the human host will typically need to be newly developed only after a pathogen has been identified. The time for conventional discovery and development of such products would require years, and not be helpful for dealing with an emergency situation. However, a number of technological advancements in recent years have supported the possibility of greatly reduced times for making such products available. These technologies can be consolidated into pathways (platforms) that are optimized for the discovery, development, and manufacturing of countermeasures to be developed as needed. The goal of this BAA is to promote and advance the establishment of workable platforms that will provide the capability for rapid countermeasure response. Support provided by BARDA will help to refine and evaluate such platforms and ensure their readiness to be applied in the case of future emerging infectious disease events.

BARDA funding bridges the “valley of death” characterizing the late stages of product development. BARDA’s support ensures continuity of funding at a critical point for medical countermeasures developed by industry or emerging from the basic research and preclinical development activities sponsored by the National Institutes of Health (NIH). Contracts resulting from this BAA may also benefit from multiple core services that BARDA provides already, and will provide, in the future. These core services include an animal study network, flexible manufacturing facilities, and technical expertise in development, manufacturing, regulatory affairs, quality systems, and clinical studies

BARDA’s priorities are aligned with the preparedness mission of the HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE), as articulated in the 2012 PHEMCE Strategy and Implementation Plan.

For additional requirements information:

The Pandemic and All Hazard Preparedness Act6 Pub. L. No. 109-417, 42 U.S.C.

§ 241 et seq. (PAHPA) and

The Pandemic and All Hazard Preparedness Reauthorization Act Pub. L. No.

113-57, (PAHPRA) authorizes BARDA to (i) conduct ongoing searches for, and support calls for, potential qualified countermeasures and qualified pandemic or epidemic products; (ii) direct and coordinate the countermeasure and product advanced research and development activities of the Department of Health and Human Services; (iii) establish strategic initiatives to accelerate countermeasure and product advanced research and development (which may include advanced research and development for purposes of fulfilling requirements under the Federal Food, Drug, and Cosmetic Act or section 351 of this Act) and innovation in such areas as the Secretary may identify as priority unmet need areas; and (iv) award contracts, grants, cooperative agreements, and enter into other transactions, for countermeasure and product advanced research and development.

http://www.gpo.gov/fdsys/pkg/PLAW-109publ417/pdf/PLAW-109publ417.pdf http://www.gpo.gov/fdsys/pkg/PLAW-113publ5/pdf/PLAW-113publ5.pdf http://www.gpo.gov/fdsys/pkg/PLAW-109publ417/pdf/PLAW-109publ417.pdf http://www.gpo.gov/fdsys/pkg/PLAW-113publ5/pdf/PLAW-113publ5.pdf http://www.gpo.gov/fdsys/pkg/PLAW-113publ5/pdf/PLAW-113publ5.pdf

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Learn more about legal authorities, policies, and committees8 and strategies and reports9 for pandemic influenza.

http://www.phe.gov/preparedness/legal/Pages/default.aspx https://www.medicalcountermeasures.gov/federal-initiatives/strategies-and-reports.aspx http://www.phe.gov/preparedness/legal/Pages/default.aspx https://www.medicalcountermeasures.gov/federal-initiatives/strategies-and-reports.aspx https://www.medicalcountermeasures.gov/federal-initiatives/strategies-and-reports.aspx

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Part I: Development Areas of Interest

This section presents an overview of the SST-related development projects that BARDA seeks to support through this BAA.

Offerors contemplating submitting Quad Charts and White Papers are strongly encouraged to contact BARDA technical point of contact for the respective area of interest. Be advised that after a White Paper (or full proposal) has been submitted, all communications related to that submission must be through the ASPR’s Office of Acquisitions Management, Contracts, and Grants (AMCG).

Area of Interest #1: Platform Technologies to Expedite the Identification, Development, and Manufacturing of Medical Countermeasures against Infectious Diseases

A challenge to national and global health security and biopreparedness is the ability to respond rapidly and effectively with new vaccines and drugs for newly emerged infectious diseases. Existing broad-spectrum antimicrobial drugs and other drugs may be used or re-purposed against newly identified pathogens. However pathogen-specific countermeasures including vaccines and immunotherapeutics that provide protective immunity are not available when a new infectious pathogen emerges. The time line for conventional discovery and development of such products is typically 2-5 years.

However, a number of new and innovative biological platform technologies have the potential to enable the rapid and reliable development and manufacturing of vaccines and monoclonal antibodies to known and unknown infectious diseases for preparedness and response.

I. A. In this area of interest we seek the development and demonstration of vaccine “plug-and-play” platform technologies using selected genes encoding immunoprotective proteins for designated emerging infectious diseases. The scope of work may include:

1. Cloning of genes or parts thereof encoding immunoprotective epitopes, domains, or proteins in infectious pathogens into gene expression systems or vectors;

2. Pre-clinical development in appropriate animal challenge and immunogenicity models;

3. Toxicology studies;

4. Development and qualification of master and working cell banks;

5. Development and qualification of master and working vectors, as appropriate;

6. Development and validation of a robust and controlled manufacturing process at pilot and commercial scale;

7. Development and validation of lot release tests;

8. Manufacturing of clinical investigational lots;

9. Development and validation of clinical immunogenicity assays; and

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10. Dose-ranging and safety Phase 1 clinical studies in healthy adult subjects.

Additionally a real-time demonstration of the flexibility and nimbleness of the vaccine platform technology in a response scenario is required with a designated infectious pathogen.

I. B. In this area of interest we seek platform technologies for the discovery, development and demonstration of monoclonal antibodies derived from immunoprotective proteins in newly emerged infectious diseases. The scope of this work may include:

1. Immunization and selection (primary, secondary, and lead) of monoclonal antibodies from immunized animals or survivors of infection with designated emerging infectious diseases;

2. Development of multivalent, humanized monoclonal antibodies against pathogen targets;

3. Pre-clinical development in appropriate animal challenge models;

4. Development and qualification of master and working cell banks;

5. Development and validation of a robust and controlled manufacturing process at pilot and commercial scale;

6. Development and validation of lot release tests;

7. Manufacturing of clinical investigational lots;

8. Development and validation of clinical neutralization tests or equivalent assay;

and

9. Pharmacokinetic/pharmacodynamics and safety Phase 1 clinical studies in healthy adult subjects.

Additionally a real-time demonstration of the flexibility and nimbleness of the monoclonal antibody technology in a response scenario is required with a designated infectious pathogen.

General Information

• Proposals on platform technologies submitted for consideration under this Area of Interest should fully describe all aspects of the platform and supportive technologies and should include a statement of work that applies the platform to a known pathogen or disease, as an example, to demonstrate the capabilities of the platform and allow evaluation of its feasibility and performance. The choice of pathogen or disease for the platform technologies should align with BARDA’s mission (chemical, biological, radiological, and nuclear threats, pandemic influenza, and emerging infectious diseases) and should be explained.

• The countermeasure produced may consist of the antibody or vaccine antigen itself, but alternative methods of delivery and administration, such as viral or genetic (DNA or RNA) vectors will also be considered. The description of the platform

BARDA SST BAA-16-100-SOL-00003 Page 15 technologies should describe how target genes or proteins will be identified in the countermeasure for given threats, fully address advantages and/or challenges of the final product form chosen, and cite examples of its usage for products and diseases already studied.

• The manufacturing technologies that are chosen for the platform should be suitable for commercial scale production and product delivery in an emergency response. The description of the manufacturing process should address bulk and fill finish manufacturing timelines or the ramp-up time for additional doses based on the approximate dosage versus existing capacity, taking into account any need for process scale-up or finding new capacity.

• The pre-clinical and clinical testing plan, as well as the regulatory pathway, for obtaining approval for use of products developed via the platform technologies should be outlined. Ways in which the platform technologies may facilitate this process should be explained. Ways in which the platform technologies and resulting countermeasures may face regulatory challenges should also be identified.

Offerors for Area of Interest #1 should describe the maturity level of their proposed technology. The Technology Readiness Level ranking criteria can be found in Attachment 1B of this solicitation. Proposed activities should offer clinical and public health benefits.

Technical Point of Contact: Mark Craven; mark.craven@hhs.gov mailto:Rodney.Wallace@hhs.gov

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Part II: R e s e r v e d

Part III: Reporting Requirements and Deliverables

Some reports and other deliverables are relevant to specific activities that may or may not be performed during the contract period of performance. The Offeror and the Government will agree during final contract negotiations on which reports and other deliverables are relevant and will be required as deliverables as determined in the negotiated SOW.

As part of the work to be performed under this BAA, the Contractor will prepare and deliver the following reports throughout the period of performance. Each document should be submitted electronically in Microsoft Word, Microsoft Excel, Microsoft Project, and/or Adobe Acrobat PDF file formats.

The following reports are not elements of the Full Proposal submission. They may be required as deliverables during the period of performance of a contract.

Reports:

1. Technical Progress Reports The frequency of Technical Progress Reporting will be determined by the Government during negotiation of the contract. Typically, on the fifteenth (15) day of each month, the Contractor will submit to the Contracting Officer and the COR a Technical Progress Report describing activities performed during the previous calendar month. The appropriate formats for the Technical Progress Report and Executive Summary will be provided by the COR. The Technical Progress Reports will include project timelines and summaries of product manufacturing, testing, and clinical evaluation activities. A Technical Progress Report will not be required for the month in which the Final Report is due. The Contractor should submit one (1) electronic copy of the Technical Progress Report. Any Technical Progress EVM Report documents should be submitted in Microsoft Word, Microsoft Excel, Microsoft Project, and/or Adobe Acrobat PDF file formats. The Contractor should inform the Contracting Officer and the COR in advance if the delivery of a Technical Progress Report will be delayed.

2. Final Report By the expiration date of the contract, the Contractor will submit a comprehensive Final Report that details, documents, and summarizes the results of all work performed under the contract. A draft Final Report will be submitted to the Contracting Officer and COR for review and comment, after which the Final Report will be submitted. The Contractor should submit two (2) paper copies and one (1) electronic copy to the Contracting Officer and COR.

There may be additional reports and deliverables required in the final negotiated contract.

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Meetings:

The Contractor will participate in regular meetings to coordinate and oversee the contract effort as directed by the Contracting Officer and COR. Such meetings may include, but are not limited to, all Contractors and subcontractors to discuss clinical manufacturing progress, product development, product assay development, scale-up manufacturing development, clinical sample assay development, preclinical/clinical study designs and regulatory issues, or other relevant activities; meetings with individual Contractors and other HHS officials to discuss the technical, regulatory, and ethical aspects of the program; and meeting with Government technical consultants to discuss technical data provided by the Contractor.

Monthly teleconferences between the Contractor and subcontractors and BARDA will be held to review technical progress. BARDA reserves the right to request more frequent teleconferences and face-to-face meetings depending on the nature and importance of the work being performed. The Contractor will receive feedback from BARDA during the monthly teleconference regarding contract performance. The Contractor will have an opportunity to respond and recommend corrective actions.

The only contractual relationship will be between the Government and the prime Contractor. No business obligation exists between the Government and any subcontractors unless a teaming arrangement is established.

Regulatory and Quality Management:

FDA submissions and meetings:

a. The Contractor will forward the dates and times of any meeting with the FDA to BARDA and make arrangements for BARDA staff to attend.

b. The Contractor will provide BARDA the opportunity to review and comment on any documents prior to submission to the FDA. The contractor should provide BARDA with a minimum of five (5) business days to provide comments back to the Contractor.

c. The Contractor will forward the initial draft minutes and final draft minutes of any formal meeting with the FDA to BARDA.

d. The Contractor will provide BARDA with the final draft minutes of any informal meeting with the FDA.

e. The Contractor will forward copies of any relevant Standard Operating Procedures upon request from the Government.

f. The Contractor will provide upon request animal study and/or other data packages developed under this contract. Packages shall include complete protocols and information on critical reagents for animal models developed and/or improved with contract funding.

g. The Contractor will provide upon request raw data and/or specific analysis of data generated with Government funds.

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Audits / Site Visits:

FDA Audits

Within thirty (30) calendar days of an FDA audit of Contractor or subcontractor facilities, the Contractor shall provide copies of the audit findings, final report, and a plan for addressing areas of nonconformance to FDA regulations and guidance for Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP) or Good clinical practice (GCP) guidelines as identified in the final audit report.

Other U.S. Government Audits

The Government reserves the right to conduct an audit of the Contractor with 48 hours notice. The Government reserves the right to accompany the Contractor on routine and for-cause site visits and audits of subcontractors. At the discretion of the Government and independent of testing conducted by the Contractor, BARDA reserves the right to conduct site visits and audits and collect samples of product held by the Contractor and subcontractors.

Program Management Plans and Documentation:

1. Integrated Master Schedule: An Integrated Master Schedule (IMS), also known by its graphical representation as a Gantt chart, will be submitted by the Offeror as part of their Full Proposal and will be incorporated into the contract. The IMS shall include the key contract progress milestones and Go/No-Go decision criteria. The IMS for the period of performance will be negotiated prior to award.

2. Integrated Product Development Plan: Within fourteen (14) calendar days of the effective date of an award, the successful Offeror (or Contractor) shall submit an updated Integrated Product Development Plan (IPDP) which shall be approved by the Contracting Officer’s Representative and the Contracting Officer prior to initiation of any activities related to their implementation.

During the course of contract performance, in response to a need to change the IPDP, the successful Offeror (or Contractor) shall submit a Deviation Report. This plan shall request a change in the agreed-upon Plan and timelines. This plan shall include:

a. Discussion of the justification/rationale for the proposed change.

b. Options for addressing the needed changes from the approved timelines, including a cost-benefit analysis of each option.

c. Recommendations for the preferred option that includes a full analysis and discussion of the effect of the change on the entire product development program, timelines, and budget.

3. Risk Management Plan: The Offeror will propose a risk management plan to identify potential risks that may arise during the life of the contract and the impact of these risks on cost, schedule and performance, and appropriate remediation plans. This plan should reference relevant Work Breakdown

BARDA SST BAA-16-100-SOL-00003 Page 19

Structure (WBS) elements where appropriate. The format for such a plan and timeline for submission will be determined during contract negotiations.

Learn more about ASPR Business Toolkit10 for additional program management information and templates.

Earned Value Management:

Earned Value Management Systems (EVMS) will be required under contracts in excess of $10M and may be required for contracts in a smaller dollar amount when the contracted work falls within a certain technology readiness level (TRL). Learn more about Tools for Monitoring Development Progress11.

Offerors will be informed of the need for implementation of an EVMS after at the time of invitation for full proposal or during negotiations. Learn more about AMCG’s implementation of Earned Value Management systems12.

http://www.phe.gov/about/amcg/contracts/Pages/toolkit.aspx https://www.medicalcountermeasures.gov/federal-initiatives/guidance/about-the-trls.aspx http://www.phe.gov/about/amcg/contracts/Pages/evm.aspx http://www.phe.gov/about/amcg/contracts/Pages/toolkit.aspx https://www.medicalcountermeasures.gov/federal-initiatives/guidance/about-the-trls.aspx http://www.phe.gov/about/amcg/contracts/Pages/evm.aspx

BARDA SST BAA-16-100-SOL-00003 Page 20

Part IV: Special Considerations

Special Instructions will be posted as amendments to the BAA on FedBizOpps when they become apparent. Please monitor this solicitation for future special instructions. In addition, please consider the following:

A. Contractor Responsibility Regarding Sensitive Information:

The Contractor will investigate violations to determine the cause, extent, loss or compromise of sensitive program information, and corrective actions taken to prevent future violations. The Contracting Officer in coordination with BARDA will determine the severity of the violation. Any contractual actions resulting from the violation will be determined by the Contracting Officer.

B. Security Plan:

In the event a security plan is needed for this requirement, the Contracting Officer will make a determination and inform the offeror of the need for a security plan. Should a security plan be requested, all pertinent documents for the creation of one will be provided to the offeror by the Contracting Officer.

C. Identification and Disposition of Data:

The Contractor will be required to provide certain data generated under this contract to the HHS. HHS reserves the right to review any other data determined by HHS to be relevant to this contract. The contractor shall keep copies of all data required by the FDA relevant to this contract for the time specified by the FDA.

D. Confidentiality of Information:

The following information is covered by HHSAR Clause 352.224-70, Privacy Act (January 2006): Data obtained from human subjects.

E. Publications:

Any manuscript or scientific meeting abstract containing data generated under this contract must be submitted to BARDA Contracting Officer’s Representative for review no less than thirty (30) calendar days for manuscripts and fifteen (15) calendar days for abstracts before submission for public presentation or publication. Contract support shall be acknowledged in all such publications. A "publication" is defined as an issue of printed material offered for distribution or any communication or oral presentation of information.

F. Press Releases:

The Contractor agrees to accurately and factually represent the work

BARDA SST BAA-16-100-SOL-00003 Page 21 conducted under this contract in all press releases. Misrepresenting contract results or releasing information that is injurious to the integrity of the Government may be construed as improper conduct. Press releases shall be considered to include the public release of information to any medium, excluding peer-reviewed scientific publications. The contractor shall ensure that the Contracting Officer’s Representative has received an advance copy of any press release related to this contract not less than four (4) working days prior to the issuance of the press release.

G. Export control notification:

Offerors are responsible for ensuring compliance with all export control laws and regulations that maybe applicable to the export of and foreign access to their proposed technologies. Offerors may consult with the Department of State with any questions regarding the International Traffic in Arms Regulation (ITAR) (22 CRF Parts 120-130) and /or the Department of Commerce regarding the Export Administration Regulations (15 CRF Parts 730-774).

H. Manufacturing Standards:

The Good Manufacturing Practice Regulations (GMP)(21 CFR Parts 210-

211) and regulations pertaining to biological products (21 CFR Part 600) and regulations pertaining to diagnostic products (21 CFR Part 860) will be the standard to be applied for manufacturing, processing, packaging storage and delivery of this product.

If at any time during the life of the contract, the Contractor fails to comply with GMP in the manufacturing, processing, packaging, storage, stability and other testing of the manufactured drug substance or product and delivery of this product and such failure results in a material adverse effect on the safety, purity or potency of the product (a material failure) as identified by the FDA , the Offeror shall have thirty (30) calendar days from the time such material failure is identified to cure such material failure. If the Offeror fails to take such an action to the satisfaction of the USG Contracting Officer’s Representative within the thirty (30) calendar day period, then the contract may be terminated.

I. Prohibition on contractor Involvement with Terrorist Activities:

The Contractor acknowledges that U.S. Executive Orders and Laws, including but not limited to Executive Order 13224 and Public Law 107- 56, prohibit transactions with, and the provision of resources and support to, individuals and organizations associated with terrorism. It is the legal responsibility of the contractor to ensure compliance with these Executive Orders and Laws. This clause must be included in all subcontracts issued under this contract.

J. Invoices:

The Contracting Officer and Contractor will discuss the Contract Type

BARDA SST BAA-16-100-SOL-00003 Page 22 during contract negotiations. Regardless of contract type, a successful contractor should expect requirements similar to the following invoicing requirements:

1. The contractor agrees to provide a detailed breakdown on invoices of the categories similar, but not limited to, the following:

a. Direct Labor - List individuals by name, title/position, hourly/annual rate, level of effort, and amount claimed.

b. Fringe Benefits - Cite rate and amount

c. Overhead - Cite rate and amount

d. Materials & Supplies - Include detailed breakdown when total amount is over $1,000.

e. Travel - Identify travelers, dates, destination, purpose of trip, and amount. Cite COA, if appropriate. List separately, domestic travel, general scientific meeting travel, and foreign travel.

f. Consultant Fees - Identify individuals and amounts.

g. Subcontracts - Attach subcontractor invoice(s).

h. Equipment - Cite authorization and amount.

i. G&A - Cite rate and amount.

j. Total Cost

k. Fixed Fee

l. Total CPFF (if applicable)

2. Monthly invoices must include the cumulative total expenses to date, adjusted (as applicable) to show any amounts suspended by the Government. In order to verify allowability, further breakdown of costs may be requested at the Government’s discretion.

3. The contractor agrees to immediately notify the Contracting Officer in writing if there is an anticipated overrun (any amount) or unexpended balance (greater than 10 percent) of the amount allotted to the contract, and the reasons for the variance. Also refer to the requirements of the Limitation of Cost (FAR 52.232-

20) clause in the contract..

BARDA SST BAA-16-100-SOL-00003 Page 23

Part V: Quad Chart/White Paper Instructions (Stage 1)

The application process is in two stages as follows:

Quad Chart/White Paper (Stage 1)

Full Proposal (Stage 2) o Volume I - Technical Proposal o Volume I – Technical Proposal Attachments o Volume II - Cost Proposal o Volume II – Cost Proposal Attachments

Stage 1: Quad Chart and White Paper Preparation

Interested Offerors shall submit a Quad Chart, and White Paper which expands on the information provided in the Quad Chart. The initial submission is limited to a cover page, one-page Quad Chart, White Paper not to exceed ten (10) pages, and an addendum (not to exceed two (2) pages) as discussed below. This results in a submission packet not to exceed 14 pages. If submissions exceed these limitations, only those pages previously defined will be reviewed.

Combine all files and forms into a single searchable PDF file before submitting.

Complete a cover sheet, Quad Chart, White Paper and a Rough Order of Magnitude (ROM) estimate of costs must be submitted in accordance with the preparation guidance below. The Quad Chart and White Paper should describe the effort in sufficient detail to allow evaluation of the concept's technical merit and its potential contribution to the BARDA mission. Offerors whose Quad Chart and White Paper receive a favorable evaluation will be invited to submit a Full Proposal [Stage 2]. Offerors whose Quad Chart and White Paper did not receive a favorable evaluation will be notified by email. Note that an offeror who receives an unfavorable rating is not precluded from a submitting a Full Proposal, however, it is strongly recommended the offeror resubmit a revised white paper.

As a white paper is not considered a “proposal,” no debriefing will be provided defined by FAR Subpart 15.5.

Quad Chart Format: The format, information and sample template is located in Attachment #5. All Quad Charts should be laid out in landscape format.

1. Heading: Title, BAA#, Development Area of Interest, Technical/Administrative point of contact (Name, Email, Phone), Company’s Name & Address

2. Upper left: Objective, description of effort

3. Lower left: Benefits of proposed technology,…