21_75A50126R00001_RFP_0001_RFP File 2 of 3.pdf

• Notify BARDA prior to any disposal of material acquired in current and prior contracts, records, documentation, and/or reports for consultation and disposition.

• Dispose of material following all federal and state regulations for the appropriate waste category: hazardous waste (e.g., thimerosal-containing product), regulated medical waste (e.g. LAIV), solid waste (e.g., non thimerosal-containing product, non LAIV), etc.

• Provide documentation (e.g. Certificate of Destruction, COD) and reports on the performed and completed disposal activity, which must include lot/batch identifying details with total quantity disposed (total lots, volume/mass, final containers).

• Deliver a final report including, at minimum, the information identified in the ‘Deliverables Table’ and specified in the RTOR.

• Due to the highly speculative nature of product disposal for this requirement, it is not possible to estimate, with any degree of certainty, the scope and amount required over the life of the IDIQ. As such, this Activity will not be priced at the IDIQ level, but instead at the task order (TO) or Blanket Purchase Agreement (BPA) level. TO/BPA Contracting Officers must determine price reasonableness prior to TO or BPA award.

ACTIVITY 1015: Emerging Pathogen(s)

• The Contractor must perform activities as required by BARDA and as specified in an

RTOR.

• Develop, update, and submit the regulatory documentation supporting the use of the material during interpandemic periods, pandemic periods, pre-pandemic preparation, pandemic response and, where appropriate, manufacture of licensed or authorized doses.

• Due to the highly uncertain and speculative nature of this Activity, it is not possible to estimate, with any degree of certainty, the scope and amount required over the life of the IDIQ. As such, this Activity will not be priced at the IDIQ level, but instead at the task order (TO) or Blanket Purchase Agreement (BPA) level.

TO/BPA Contracting Officers must ensure enforcement of applicable FAR cost principles and determine cost reasonableness prior to TO or BPA award.

ACTIVITY 1016: Validation Activities or Technology Transfer Activities For situations in which a manufacturing activity would require validation activities, a technology transfer, or other activities related to a new product (e.g., new presentation or formulation of antigen and/or adjuvant at an existing location, or an existing product at a new location, etc.), the Contractor must:

• Perform validation activities or technology transfer activities (e.g., within the facility, to a CMO) if needed to complete requirements in the SOW of the Task Order. Validation activities must be carried out at facilities in compliance with FDA-CGMP guidelines.

• Assure compliance of process validation following regulation for validating pharmaceutical (drug) manufacturing (section 501(a)(2)(B) of the Act (21 U.S.C.

351(a)(2)(B)) and FDA regulations describing CGMP for finished pharmaceuticals provided in 21 CFR parts 210 and 211.

• Update and submit the regulatory documentation supporting the use of the material during interpandemic periods, pandemic periods, pre-pandemic preparation, pandemic response and, where appropriate, manufacture of licensed or authorized doses.

• Provide to BARDA all validation plans for technology transfer.

• Provide technology transfer report(s).

• Provide process validation report(s) to BARDA. The report should include, at minimum:

• Manufacturing location (building, room, city, country)

• Dates of major manufacturing steps

• Major process inputs and parameters (e.g., number of eggs, bioreactor size, working volume, cell bank number, CVV ID and source and lot number, MVS and/or WVS, lot number history)

• Volume produced, lot size, quantity/number

• Potency and/or quantity per volume (e.g., µg/mL, FFU/mL)

• Manufacturing and testing deviations

• Certificate(s) of analysis (in English)

• Certificate(s) of compliance (in English)

• Due to the highly speculative nature of validation and technology transfer activities for this requirement, it is not possible to estimate, with any degree of certainty, the scope and amount required over the life of the IDIQ. As such, this Activity will not be priced at the IDIQ level, but instead at the task order (TO) or Blanket Purchase Agreement (BPA) level. TO/BPA Contracting Officers must determine price reasonableness prior to TO or BPA award.

ACTIVITY 1017: Manufacturing Enhancements The Contractor must:

• Develop enhancements to the underlying manufacturing process(es) to improve production yield, breadth, accessibility, durability, reactogenicity, or other improvements as outlined in the SOW of the Task Order.

• Develop innovations in manufacturing or testing to allow more rapid vaccine upscaling and deployment.

• Update and submit the regulatory documentation supporting the use of the material during interpandemic periods, pandemic periods, pre-pandemic preparation, pandemic response and, where appropriate, manufacture of licensed or authorized doses.

• Provide final report including at minimum:

• Manufacturing location (building, room, city, country)

• Dates of major manufacturing steps

• Major process inputs and parameters (e.g., number of eggs, bioreactor size, working volume, cell bank number, CVV ID and source and lot number, MVS/WVS lot number)

• Volume produced, lot size, quantity/number

• Potency and/or quantity per volume (e.g., µg/mL, FFU/mL)

• Manufacturing or testing deviations

• Certificate(s) of analysis (in English)

• Certificate(s) of compliance (in English)

• Testing parameters and feasibility data including comparison to a commonly acceptable standard or benchmark.

• Due to the highly speculative nature of manufacturing enhancements for this requirement, it is not possible to estimate, with any degree of certainty, the scope and amount required over the life of the IDIQ. As such, this Activity will not be priced at the IDIQ level, but instead at the task order (TO) or Blanket Purchase Agreement (BPA) level. TO/BPA Contracting Officers must determine price reasonableness prior to TO or BPA award.

ACTIVITY 1018: Tariffs, Duties, and Trade Remedies (Pass-Through) This Activity is established to reimburse Contractor for actual, allowable tariffs, duties, or trade remedy costs imposed by the U.S. Government after contract award, including but not limited to Section 232 of the Trade Expansion Act and Section 301 of the Trade Act of 1974, anti-dumping, or countervailing duties, that directly impact the cost of supplies, materials, components, or equipment required on any ACTIVITY(-IES).

The Contractor must separate and individually invoice any government-imposed tax or duty on goods associated with ACTIVITY(-IES) performed under this contract, applied in accordance with applicable laws and regulations.

Reimbursement under this Activity is limited to:

• Tariff costs actually incurred and paid

• Costs that are allocable solely to this contract

• Costs that are not included in any other Activity

No profit, fee, overhead, general and administrative expenses, or markups shall be applied to costs reimbursed under this Activity.

Due to the highly speculative nature of tariffs for this requirement, it is not possible to estimate, with any degree of certainty, the scope and amount required over the life of the IDIQ. As such, this Activity will not be priced at the IDIQ level, but instead at the task order (TO) or Blanket Purchase Agreement (BPA) level. TO/BPA Contracting Officers must determine price reasonableness prior to TO or BPA award.

ACTIVITY 1019: Standard Data Reporting Requirements The Contractor must submit detailed data regarding project materials, sources, and manufacturing sites. This is required to be complete prior to BARDA deliverable acceptance and subsequent invoicing.

These standard reporting requirements will be applicable, at a minimum, to every regular cadence report, interim product reporting, and final deliverables. In the event of a public health emergency, BARDA may require daily reporting of manufacturing campaigns during readiness and/or response operations.

The Contractor must conform to the file specification and layout as provided by BARDA to submit data and is expected to adopt minor modifications periodically provided by BARDA. Final data elements with associated definitions and standard units of measure (e.g., mass, volume per batch) will be agreed upon prior to data submissions.

Data categories will include but are not limited to the following:

• Manufacturing locations

• Seed development or other starting material manufacturing

• Critical materials

• Manufacturing production projections

• Bulk drug substance and/or adjuvant production to include per batch yield data

• Fill, finish, and release of product or adjuvant

• Storage/inventory of starting materials, bulk substance, or filled/final product or adjuvant

• Stability information of bulk substance and/or finished product

• Shipment of bulk substance or final finished product

• Disposal of bulk substance or final product

• Location and nature of nonclinical study and/or clinical study sites

ACTIVITY 1020: Additional Reporting The Contractor must:

• Submit inventory reports, monthly progress reports, executive summaries, Government Property reports, interim product reports, ad hoc reports of urgent developments related to this program, and a final report as described in detail in the Reporting Requirements and Deliverables. Reports must be delivered as separate BARDA-specific and DOW/DHA-specific (or other U.S. Government agency) reports to enable direct sharing with BARDA partners.

• Annually, submit an updated table describing facility availability and capacity to complete all CLIN activities throughout the year per a BARDA defined template to be provided (Attachment 3).

• Annually review, assess, and update, as applicable, all Contract-required plans, plan deliverables, and associated supporting documentation to ensure they remain current, accurate, and consistent with contract requirements, operational capabilities, regulatory requirements, and BARDA direction. Updated versions must be submitted to the Government in accordance with the Reporting Requirements and Deliverables or as otherwise requested by the COR or CO.

• Respond to request(s) for additional information from BARDA pertaining to activities related to Contract, including provision of raw data or specific analyses of data generated with contract funding to the COR or CO, upon request.

• Make appropriate updates to the regulatory documentation supporting relevant regulatory file and continued use of the stored material for pre-pandemic preparation, pandemic response and, where appropriate, manufacture of licensed or authorized doses.

• Provide BARDA with clinical and regulatory support for specific studies and research and development.

• Respond to data calls as required by BARDA and in a standard format as defined by

BARDA.

C.4. Interagency Collaboration and Use by the Department of War (DOW)

Given the national security implications of pandemic influenza and other emerging biological threats, BARDA may collaborate with other United States Government (USG) agencies to advance preparedness and response capabilities under this program. In particular, the

Department of War (DOW) and its components, including but not limited to the Defense Health Agency (DHA), may partner with BARDA to support the development, manufacturing, stockpiling, and evaluation of medical countermeasures (MCMs) under this contracting vehicle.

To facilitate a coordinated national biodefense posture, DOW components may utilize this contract through interagency agreements, Economy Act transactions, or other authorized funding mechanisms to support activities consistent with the scope of this program. Such activities may include, but are not limited to, pandemic influenza vaccine development, advanced manufacturing capabilities, antigen and adjuvant production, clinical evaluation, regulatory data generation, and surge manufacturing readiness.

Work conducted on behalf of DOW under this contract shall remain within the technical scope of the Vaccine Medical Countermeasures for Pandemic Influenza Preparedness and Response Program and shall be coordinated with BARDA to ensure alignment with national public health preparedness priorities. Funding for such efforts may be provided by DOW or other participating agencies in accordance with applicable federal laws, regulations, and interagency agreements.

C.5. Additional Requirements

Standard Operating Procedures (SOPs)

• Upon request from the COR or CO, the Contractor must make internal and, to the extent possible, Subcontractor SOPs available for review by the Government on-site at Contractor's facility. At the Contractor's election, SOPs may be provided electronically.

Data Management

• The Contractor must develop and implement data security, data management, and data quality control systems/procedures; including transmission, storage, confidentiality, and retrieval of all contract data; as applicable provide for the statistical design and analysis of data resulting from the research; provide raw data or specific analyses of data generated with contract funding to the COR or CO, upon request.

Manufacturing

• Contractors holding a U.S. license for an influenza vaccine or submitted a BLA to the

U.S. FDA must perform all work described in the ACTIVITIES according to those of their FDA-licensed or BLA-submitted influenza vaccine product processes. This includes use of the same validated facilities, systems, equipment, and manufactured processes for CGMP manufacturing of licensed influenza vaccine, antigen, and adjuvant product.

Contractors must use the same validated and approved assays and equipment for lot release of influenza vaccine, antigen, and adjuvant product and final container influenza vaccine, antigen, and adjuvant products and stability studies. Contractors must use the same validated facilities, systems, and equipment suitable for CGMP storage of influenza vaccine, antigen, and adjuvant products. Exceptions may be requested from

• If a Contractor’s manufacturing facility is outside the continental U.S. (OCONUS), manufactured material must be shipped to the U.S. within 60 days of lot release and entered into storage per Storage and Stability ACTIVITY. An exception to this requirement may be requested from BARDA. Shipment of the material to the U.S. must be coordinated with BARDA and other offices/agencies involved in importation of vaccines as appropriate. Importation of bulk antigen and adjuvant into the U.S. may require testing which must be performed according to applicable federal guidelines (e.g., FDA, USDA, CDC). The Contractor must bear all costs for shipping and testing required for import into the U.S. Under FAR 52.243-2 Alt V (changes clause – Cost reimbursement), This requirement can be unilaterally modified by BARDA during a public health emergency, as defined by BARDA, to allow for international formulation and filling prior to shipment to the U.S. Vendors should follow the process in FAR 52.243-2 Alt V to seek reimbursement of this expense. If the Contractor has domestic/international facilities for primary and secondary manufacturing or storage, products must be shipped from/to different facilities at no additional cost to the U.S.

government.

• BARDA must be notified in advance of any planned facility shutdowns and as soon as feasible for any unplanned facility shutdowns (e.g., facility upgrades, maintenance, etc.).

• Alternative potency assays may be used when CBER reagents are not available and must be approved by BARDA. When reagents become available, potency determination must be bridged to SRID testing. Parallel testing with both assays must continue for at least 3 time points of the stability program to document comparability. Where appropriate and/or requested by BARDA, such comparability documentation is to be submitted to FDA to evaluate feasibility of alternate potency testing for lot release under 21 CFR

610.9 Equivalent Methods and Processes.

• Non-marketed product(s): the Contractor must develop and submit a Commercial

Sustainability Plan that outlines a comprehensive strategy to ensure the long-term availability, affordability, and scalability of the non-marketed product(s) procured under this contract. This plan must address the transition from government-supported warm-base to a commercially viable model, including a risk-based approach to ensure a reliable supply chain, pathways for regulatory approval, manufacturing scale-up, market entry, and post-market support.

Quality Assurance

• Contractor must accommodate periodic or ad hoc site visits, auditing, inspection, and review of release documents, test results, equipment, and facilities when requested by

BARDA.

BARDA may assess Contractor’s facility and quality systems and make a determination in regard to the site’s acceptability and compliance in relation to its ability to manufacture, process, pack, properly and safely store and handle the USG-owned product.

• Incidents: BARDA must be informed of all major and critical issues involving any of the material or studies managed under this contract within 48 hours of the incident and within 24 hours of a security activity or incident. Initial impact assessment and remediation plan must be provided within five (5) business days of the incident.

Investigation reports with applicable Corrective and Preventative Actions (CAPAs) must be submitted within forty-five (45) business days of incident onset.

Biosafety

• Manufacturing facilities must be in compliance with appropriate biosafety level bio-containment procedures.

• As applicable, contractors must use the approved facilities, equipment, and policies to receive, store, utilize, and dispose of bio-hazardous materials in appropriate conditions.

• As appropriate, Contractors must employ approved biosafety measures compliant with CDC biosafety guidelines (Biosafety in Microbiological and Biomedical Laboratories (BMBL), https://www.cdc.gov/labs/bmbl/) including protective garments, equipment, sufficient monitoring to assure safe handling of potentially hazardous materials for the safety and protection of workers.

• Contractors must conduct work under the contract in accordance with all applicable and current Federal, state, and local laws, codes, ordinances and regulations.

U.S. Government Property

• Materials manufactured and/or stored under this contract are ‘U.S. Government

Property.’ These materials must be maintained in the Contractor’s quality and inventory systems, ready for use in the continued manufacture of bulk material or final container doses intended for clinical assessment, use under the license, or use as part of a public health emergency.

• Notification must be given to BARDA prior to any disposal of material, records, documentation, and/or reports for consultation and disposition.

Assessments

• The Contractor must conduct or participate in assessments and tabletop exercises on an annual basis, or at such other times as may be requested by BARDA, for the purpose of evaluating preparedness and response postures.

SECTION D – PACKAGING, MARKING AND SHIPPING

D.1. SHIPPING

Method of Delivery Unless otherwise specified by the Contracting Officer, all non-physical deliverable items (e.g., reports, plans, documents, invoices, etc.) to be furnished to the Government under this contract must be uploaded to BARDA’s document sharing system as described in SECTION F.3.

All physical deliverables required under this contract must be packaged, marked, and shipped in accordance with Government specifications. At a minimum, all deliverables must be marked with the contract number and Contractor’s name. The Contractor must guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

D.2. PREPARATION OF PRODUCT FOR TRANSPORT

All vaccines shall be labeled, packaged, and marked in standard commercial manner (with labeling and packaging configuration directions to be provided at the time of the government places an order and subject to FDA approval). Products shall be packed to ensure maintenance of FDA recommended temperature during transit and safe arrival at destination. A mutually agreed upon temperature monitoring device shall be packed in each shipper containing influenza vaccine. The location of the sensing probe shall have been previously determined by the Contractor through the performance of shipping validation studies. The Contractor is required to maintain records that document the date of delivery receipt, and that the vaccine was properly maintained within the recommended cold chain temperatures during transit and receipt (Attachment 4). In the event of out of specification (OOS) results are obtained, such results shall be reported by the Contractor to BARDA within 24 hours of receipt of such results.

The Contractor shall open a deviation according to its established deviation standard operating procedure and must work with BARDA to determine what investigations are needed and reach a conclusion as to whether the affected shipper contents are releasable. If the affected material cannot be released, the lost value of the affected material shall be borne by the Contractor.

D.3. Free On Board (FOB) DELIVERIES

Task orders will indicate FOB Destination or Origin. Unless otherwise stated in the task order, the default delivery term shall be FOB Destination.

The Contractor must describe the storage conditions for each product, specifically noting the acceptable temperature range required to maintain product quality. The Contractor is responsible for maintaining product temperature control until the product(s) arrives at the destination and has completed product inspection and acceptance by the USG. The Contractor must provide the Government with an ambient exposure letter that covers the time the product(s) leaves the Contractor’s validated storage facility until arrival at the destination. Upon Government acceptance of the product(s) to the Government, the responsibility for temperature control shall transfer to the Government as well as the responsibility for logging ambient exposure time (temperatures between 8-25°C). The Contractor will provide and place temperature monitor(s) on each pallet of product prior to placing the product(s) onto the truck(s) of the designated carrier. The Government’s acceptance of the aforementioned responsibility applies only to temperature control and does not indicate its acceptance of the lot(s).

For any product manufactured under this contract, title to such product will transfer upon delivery of drug product to Government-designated storage site(s) and the Government’s corresponding written acceptance of the delivery of each such lot of product. These materials should be maintained in the Contractor’s quality and inventory systems, ready for use in the continued manufacture of bulk material or final container doses intended for clinical use, use under Emergency Use Authorization, or use under a BLA.

SECTION E – INSPECTION AND ACCEPTANCE

E.1. INSPECTION AND ACCEPTANCE

• Upon receipt of final report, including the updated “Dose Tracking Template”, BARDA COR will perform inspection (in person or virtually) and acceptance of product to be delivered under the contract.

The COR will notify the Contractor of acceptance or rejection. If applicable, a task order for the storage of product may be issued. Any product produced or stored under this contract shall be subject to inspection by BARDA.

Inspection and acceptance will take place at the contractor’s facility(-ies) or virtually at:

Center for the Biomedical Advanced Research and Development Authority Administration for Strategic Preparedness & Response 400 7th Street, S.W.

Washington, D.C. 20024

E.2. FAR 52.252-2 CONTRACT CLAUSES INCORPORATED BY REFERENCE (Feb 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this address:

https://www.acquisition.gov/browse/index/far

FAR 52.246-2, Inspection of Supplies – Fixed Price (August 1996) FAR 52.246-4, Inspection of Services - Fixed Price (August 1996) FAR 52.246-3, Inspection of Supplies – Cost Reimbursement (May 2001) FAR 52.246-5, Inspection of Services - Cost-Reimbursement (April 1984) FAR 52.246-7, Inspection of Research and Development – Fixed Price (August 1996) FAR 52.246-8, Inspection of Research and Development – Cost-reimbursement (May 2001) FAR 52.246-9, Inspection of Research and Development (Short Form) (April 1984) FAR 52.246-16, Responsibility for Supplies (April 1984)

SECTION F – DELIVERIES OR PERFORMANCE

F.1. ESTIMATED PERIOD OF PERFORMANCE

The base period of performance of this contract is anticipated for 60 months from date of award. The period of performance may be extended up to 60 months with the exercise of option(s), as set forth in SECTION B. If the Government exercises its option(s) pursuant to the OPTION PROVISION Article in Section H of this contract, the period of performance will be increased by an additional Sixty (60 months).

Period Duration Base Period Sixty (60 Months)

Option Period 1 Sixty (60) Months

F.2. PLACE AND METHOD OF DELIVERY

1. The delivery of the items under this contract and related supplies shall be FOB

Destination or FOB Origin as indicated in each task order award. If no FOB is indicated, the default will be FOB Destination. Successful performance of the final contract shall be deemed to occur upon performance of the work described in SECTION C of this RFP and upon delivery and acceptance of the items described in SECTION F.3 by the Contracting Officer or their duly authorized representative.

2. The place and time of delivery shall be negotiated within individual Task Orders and

BPA Call Orders.

F.3. REPORTING REQUIREMENTS and DELIVERABLES

F.3.1. Submission of Contract Deliverables

Documents must be delivered electronically to the CO and to the COR via a specified shared location.

Monthly and annual progress reports should be delivered as separate BARDA-specific and DOW/DHA-specific (or other USG agency) reports to enable direct sharing with BARDA partners.

F.3.2. Deliverable Table

The Offeror may propose combining deliverables as appropriate and upon pre-approval of the COR.

Deliverable Deliverable Description Reporting Procedures and Due Dates2

Security

Operational Security (OPSEC) Standard Operating Procedure (SOP)/Plan

This SOP/Plan will include identifying the critical information related to this award, why it needs to be protected, where it is located, who is responsible for it, and how to protect it.

• Contractor must submit an OPSEC SOP/Plan Within 90 calendar days after the initiation of the contract period of performance

Security Plan

The contractor shall develop a comprehensive security program that provides overall protection of personnel, information, data, and facilities associated with fulfilling the Government requirement. This plan shall establish security practices and procedures that demonstrate how the contractor will meet and adhere to the security requirements outlined below prior to the commencement of product manufacturing.

The contractor shall also ensure all subcontractors, consultants, researchers, etc. performing work on behalf of this effort, comply with all Government security requirements and prime contractor security plans.

• Contractor must submit a Security Plan

• Draft within 30 calendar days after the initiation of the contract period of performance

• The Government will perform an internal review in detail and submit comments within ten (10) business days to the CO and COR to be forwarded to the Contractor. The Contractor shall review the Draft Security Plan comments and submit a Final Security Plan to the U.S. Government within ten (10) calendar days after receipt of the comments.

• The Security Plan shall include a timeline for compliance of all the required security measures outlined by the Government.

• Upon completion of initiating all security measures, the Contractor shall supply to the CO and COR a letter certifying compliance to the elements outlined in the Final Security Plan.

Program Management

Project Management Plan (PMP)

The Project Management Plan should define the overall plan for how the project will be executed, monitored and controlled and must include a Study Responsibility Assignment Matrix for Contractor and subcontractor team(s).

• Contractor must submit a Project Management Plan (PMP) Within 30 calendar days after the initiation of the contract period of performance Updates should be provided to reflect any key changes, including new task order awards, and reviewed at least annually.

1 A business day is defined as any day except any Saturday, any Sunday, any day which is a federal legal holiday in the United States, or any day declared to be a holiday by federal statute or executive order, or any day with respect to which the U.S. Office of Personnel Management has announced that Federal agencies in the Washington, DC, area are closed. For purposes of calculating any deadline imposed by this contract, any submissions received after 5 p.m. Eastern Time are deemed to be submitted on the next business day.

The PMP may be a single detailed document or composed of one or more subsidiary planning documents. These additional planning documents provide guidance and direction for specific management, planning, and control activities such as schedule, cost, risk, staffing, change control, communications, quality, procurement, deployment, etc. Each of the subsidiary planning documents should be detailed to the extent required by the specific project.

Communication Plan

The Contractor must develop and implement an effective Communication Plan that details the flow of information between BARDA, Contractor, collaborators, vendors, and other organizations. This should include communications with other USG agencies (e.g., CDC) as appropriate, regarding label contents, expiry dating, healthcare provider educational materials.

The Communication Plan must also include processes for external communications and press release review.

• Contractor must submit a Communication Plan

• Within 30 calendar days after the initiation of the contract period of performance

• Updates should be provided to reflect any key changes and reviewed at least annually.

Regulatory Plan

The Contractor must provide a Regulatory Plan that outlines the regulatory strategy for the product.

The plan must include information leading to distribution readiness and information needed to support the Immunization Information Systems (IIS) data code set development.

• The Contractor must submit a Draft within 45 calendar days after the initiation of the contract period of performance; updates to the Regulatory Strategy/Plan must be submitted concurrently with Monthly Technical Progress Reports

• BARDA will provide Contractor with a list of concerns in response to plan submitted

• Contractor must address, in writing, all concerns raised by BARDA within 20 business days of Contractor’s receipt of BARDA’s concerns

Commercial Sustainability Plan

The Contractor must provide a Commercial Sustainability Plan that outlines a comprehensive strategy to ensure the long-term availability, affordability, and scalability of the non-marketed product(s) procured under this contract.

This plan must address the transition from government-supported warm-base to a commercially viable model, including a risk-based approach to

• The Contractor must submit a Draft within 45 calendar days after the initiation of the contract period of performance; updates to Commercial Sustainability Plan must be submitted concurrently with Monthly Technical Progress Reports

• BARDA will provide Contractor with a list of concerns in response to plan submitted

• Contractor must address, in writing, all concerns raised by BARDA within 20 business days of Contractor’s receipt of BARDA’s concerns ensure a reliable supply chain, pathways for regulatory approval, manufacturing scale-up, market entry, and post-market support.

Manufacturing Plan

The Contractor must develop and submit a comprehensive Manufacturing Plan in accordance with the requirements listed in Attachment 17, Manufacturing Plan (refer to Attachment 16 Bill of Materials Template).

• Due within 120 calendar days after the initiation of the contract period of performance

• The CO and COR will review the deliverable and provide feedback within 30 calendar days.

• Contractor must provide a final version of the deliverable within 30 calendar days after receiving BARDA comments/edits.

• Contractor must submit to CO and COR an updated deliverable Within 60 calendar days after each contract anniversary Prior to any events specified in Attachment 17 as communicated by the CO and

COR

If there are no updates at the times listed above, Contractor must submit to CO and COR a written confirmation that no substantive changes have occurred and that the current plan remains accurate.

• Contractor must notify the COR within 15 calendar days after identifying a material change affecting the accuracy of this deliverable; Contractor to include this update in the next submission unless an earlier due date is established.

• In the case of a public health emergency, the timeline for this deliverable will follow an accelerated timeline.

Template available upon request.

Business and Supply Continuity Plan

The Contractor must develop and submit a comprehensive Business and Supply Continuity Plan detailing the delivery of product continuity plan and support services to internal and external customers in the aftermath of a catastrophic event. This deliverable must be submitted in accordance with the requirements listed in Attachment 18, Business and Supply Continuity Plan.

• Contractor must submit to CO and COR within 120 calendar days after the effective date of the contract.

• Contractor must submit to CO and COR an updated deliverable within 60 calendar days after each contract anniversary.

Template available upon request.

Surge Manufacturing and Supply Chain Readiness Assessment

The Contractor must develop and submit a Surge Manufacturing and Supply Chain Readiness Assessment for BARDA supported product. The assessment must identify, or the CO must provide, the applicable planning scenario, target quantity, product presentation, requested delivery timeline, planning assumptions, due date, and any relevant public health emergency context. This deliverable must be submitted in accordance with the requirements listed in Attachment 19, Surge

• Upon request of the COR, the Contractor must perform and submit to the CO and COR a Surge Manufacturing and Supply Chain Readiness Assessment. The Government anticipates requesting this assessment on an annual basis; however, each assessment shall address the specific scenario identified by BARDA. The due date for each assessment will be established by the COR at the time of the request.

Manufacturing and Supply Chain Readiness Assessment.

Risk Management Plan (RMP)

The Contractor must provide an overall RMP as well as a RMP for each awarded task order that outlines the impacts of each risk in relation to the cost, schedule, and performance objectives. The plan must include assigned No strategies. Each risk mitigation strategy will capture how the corrective action will reduce impacts on cost, schedule, and performance.

• Due within 45 calendar days after the initiation of the base contract period of performance; updates to the RMP are due 1) with the response to a Request for Task Order Response (RTOR) and 2) concurrent with Monthly Technical Progress Reports and must include each task order, but may be communicated more frequently.

• BARDA will provide Contractor with a list of concerns in response plan submitted

• Contractor must address, in writing, all concerns raised by BARDA within 20 business days of Contractor’s receipt of BARDA’s concerns

Vendor-Managed Inventory (VMI) Plan Contractor must draft a VMI Plan in accordance with a template to be provided by BARDA as applicable

• The Contractor must submit the Draft VMI Plan and supporting SOPs Draft within 60 calendar days of award

• Finalized and signed by all stakeholders within 90 calendar days of award

• Updates should be provided to reflect any key changes and reviewed at least annually.

Quality Management Plan (QMP)

Contractor must develop an overall project Quality Management Plan to include a description of all quality activities and personnel involved in ensuring all activities are conducted and data are maintained under CGXP, and all products are managed to ensure that GMP requirements are met.

All quality management plans must include subcontractor quality management plans specifically addressing how subcontractor quality will be managed. All subcontractors must have a current quality agreement with the Contractor and a recent vendor qualification audit.

Contractor must submit a Quality Management Plan:

Draft within 60 calendar days of award Finalized and signed by stakeholders within 90 calendar days of award

Updates should be provided to reflect any key changes and reviewed at least annually.

Quality Agreement

The Quality Agreement defines the duties of BARDA and Contractor for the supply, quality acceptance, and storage of the product types under the contract as such both parties (Contractor and BARDA) adhere to compliance requirements set forth in Current Good Manufacturing Practices (21 CFR Parts 210 and 211), and Biological Products (21 CFR Part 600).

BARDA will issue a draft Quality Agreement to the Performer to review and sign. The terms of the

The Contractor must submit the Quality Agreement:

Draft within 60 calendar days of award Finalized and signed by stakeholders within 90 calendar days of award

Updates should be provided to reflect any key changes and reviewed at least annually.

Quality Agreement shall set forth the requirements under the contract.

BARDA Audit

Contractor must accommodate periodic or ad hoc site visits, auditing, inspection and review of release documents, test results, equipment and facilities when requested by BARDA. If BARDA, the contractor, or other parties identify any issues during an audit, the contractor must capture the issues, identify potential solutions and submit a report to BARDA detailing the finding and corrective action(s).

The Contractor must allow for up to four (4) USG Quality representative(s) to conduct an audit.

• If issues are identified during the audit, Contractor shall submit a report to BARDA detailing the finding and corrective action(s) within 10 business days of the audit

• COR and CO will review the report and provide a response to the Contractor within 10 business days

• Once corrective action is completed, the Contractor will provide a final report to

BARDA

Technical Reporting: General

Kickoff Meeting The Contractor must complete a Kickoff meeting after the initiation of the contract period of performance

• Within 30 calendar days after the initiation of the contract period of performance, pending concurrence by the Contracting Officer

• Contractor must submit agenda and itinerary, if applicable, at least 5 business days in advance of in-person meeting or teleconference

• COR edits/approves and instructs Contractor to distribute agenda at least 3 business days prior to meeting

• Contractor submits meeting minutes to COR within 3 business days after the meeting

• COR reviews, comments, and approves minutes within 10 business days

Monthly and Annual Technical Progress Reports and Meetings

The Contractor must participate in biweekly or monthly teleconferences to discuss the performance of the contract/task order.

The Monthly and Annual Technical Progress reports must address each of the below items and be cross-referenced to the Work Breakdown Structure (WBS), Statement of Work (SOW), Integrated Master Schedule (IMS), and Contract Performance Report (CPR) – or as applicable.

Monthly and annual progress reports should be delivered as separate BARDA-specific and DOW/DHA-specific (or other USG agency) reports to enable direct sharing with BARDA partners.

• The Contractor must submit monthly reports on the 15th day of the Month covering the preceding month; Annual Reports submitted on the 15th of the calendar month after each contract anniversary.

Monthly progress reports are not required for the months when the Annual Report(s) are due, and Monthly/Annual Report(s) are not due during a month when the Final Report (final version, not draft) is due. The COR and CO will review the monthly reports with the Contractor and provide feedback

• Contractor must provide FINAL versions of reports within 10 business days after receiving BARDA comments/edits

• Meeting frequency can be adjusted as needed during the course of the contract.

1. An Executive Summary highlighting the progress, issues and relevant manufacturing, nonclinical, clinical, and regulatory activities. The Executive Summary should highlight all critical issues for that reporting period and resolution approach;

limited to 2 pages

2. Management, contractual, and administrative updates including a description of all meetings, calls, etc. that have taken place during the reporting period. Include progress on administration, contractual, and management issues. For contractual issues include an updated table of contractual issues with columns for Issue Number, Task Order, Issue Description, Date of Initial Request, Impact and Status/Comment.

3. Progress in meeting contract or task order milestones organized by WBS, overall project assessment, problems encountered and recommended solutions. For each activity related to Task Order and Gantt chart, document the results of work completed during the period covered. The report must be in sufficient detail to explain comprehensively the results achieved.

The description must include baseline and updated project timelines, milestones and summaries of product manufacturing and testing.

The report must include a description of problems encountered and proposed corrective action;

differences between planned and actual progress, why the differences have occurred and what corrective actions are planned.

4. The Contractor must submit monthly detailed clinical reports during active clinical study enrollment to include data on relevant activities during the period covered, by study site, including:

cumulative enrollment; new enrollments; screen failures; patients dropped from study; AE and

SAEs; study initiation visits; activation or inactivation of study sites; investigator appointments or changes; and status of IRB/IEC review/approval/renewal

5. A three-month rolling forecast of the key planned activities, referencing the WBS/IMS

6. A tracking log of progress on regulatory submissions with the FDA number, description of submission, date of submission, status of submission, and next steps

7. Estimated and Actual Expenses

• This report must also contain a narrative or table detailing whether there is a significant discrepancy (>10%) at this time between the % of work completed and the cumulative costs incurred to date. Monthly and actual expenses should be broken down to the appropriate WBS level. This section of the report should also contain estimates for the Subcontractors’ expenses from the previous month if the Subcontractor did not submit a bill in the previous month. If the subcontractor was not working or did not incur any costs in the previous month, then a statement to this effect should be included in this report for those respective subcontractors. If the COR and CO are satisfied that the Contractor’s reporting is sufficient to convey this information, this section may be waived.

• Summary of any invoices submitted during the reporting period. Include an updated table with columns for Invoice number, Date Submitted, Amount, Activity/Comments and Date paid. The summary invoice table should include all invoices from contract award to reporting period.

8. Publication activities and progress for any manuscript, scientific meeting abstract, poster, presentation, and other public-facing material or information containing data generated under this contract

9. ACTION ITEMS - Summary table of activities or tasks to be accomplished by a certain date and by whom.

10. APPENDIX: Standard Data Reporting (ACTIVITY

0019)

Gantt Chart/Timeline The Gantt Chart/Timeline should be detailed to the extent required by the specific project.

• At first project meeting and as updated no later than once per month as part of the monthly report. Provided in pdf and Microsoft Excel. If there are urgent readiness or response activities, this may be required daily.

Integrated Master Schedule (IMS)

The Contractor must provide an IMS that illustrates project tasks, dependencies, durations throughout the period of performance, and milestones (GO/NO-GO).

The IMS must map to the WBS, and provide baseline, and actual or forecast dates for completion of tasks

Contractor must notify BARDA of significant proposed changes to the IMS. Significant changes are defined as increases in cost above 5% or schedule slippage of more than 30 days, which would require a PoP extension. Contractor must provide a high-level management strategy for risk mitigation.

• The Contractor must submit the IMS in both PDF and an agreed-upon electronic format (e.g., Microsoft Excel) to the COR

• The first Draft of the IMS is due within 30 calendar days after the initiation of the contract period of performance

• Thereafter an updated IMS is due concurrent with Monthly Technical Progress Reports and must incorporate each task order

• The Contractor must submit significant proposed changes to the IMS at least 10 business days prior to the Contractor anticipating the need to implement changes.

• During a public health emergency, the Contractor must submit the IMS within 10 business days after the initiation of the task order period of performance, updates are due weekly, and any significant change (i.e., a change which would impact the schedule by greater than one week) must be reported immediately to the COR and/or designee.

Draft and Final Contract and Task Order Technical Progress Report

A draft Final Contract and Task Order Technical Progress Report must contain a summation of the work performed and the results obtained over the entire contract. This report must be in sufficient detail to fully describe the progress achieved under all milestones for all task orders. Report must contain a timeline of originally planned and baselined activities and milestones overlaid with actual progress attained

• The Contractor must submit the Draft Final Technical Progress Report 45 calendar days before the end of the PoP and the Final Technical Progress Report on or before the completion date of the PoP

• COR will provide feedback on draft report within 15 calendar days of receipt, which the Contractor must consider incorporating into the Final Report during the contract. Descriptions and rationale for activities and milestones that were not completed as planned should be provided. The draft report must be duly marked as ’Draft.’

The Final Technical Progress Report incorporating feedback received from BARDA and containing a summation of the work performed and the results obtained for the entire contract PoP. The final report must document the results of the entire contract. The final report must be duly marked as ’Final’. A cover letter with the report will contain a summary (not to exceed 200 words) of salient results achieved during the performance of the contract or task order.

Technical, Subgroup, or Ad hoc Teleconference(s)

The Contractor must participate in technical, subgroup, or ad hoc teleconferences as needed or upon BARDA request to discuss the technical performance on the contract.

Meeting frequency may be defined as needed during the course of the project.

• Contractor must submit agenda to COR no later than 2 business days in advance of Technical or Subgroup meeting

• COR edits/approves and instructs Contractor to distribute agenda prior to meeting

• Contractor must distribute agenda and presentation materials at least 24 hours in advance of meeting

• Contractor must submit meeting minutes to COR within 3 business days of the meeting

• COR reviews, comments, and approves minutes within 6 business days

Daily, Weekly, or As-Required Check-In with BARDA

Upon request of the Government, the Contractor must participate in a daily or as-required check-in update with the project staff (via teleconference or email) during pandemic readiness or response efforts or public health emergency.

Meeting frequency may be increased or decreased as needed during the course of the project.

The updates will address key cost, schedule, and technical updates. Daily updates may be shared with senior Government leaders and should be provided on a non-confidential basis, unless the update includes confidential information in which case Contractor must provide the update in both confidential and non-confidential formats.

Daily check-ins may occur on weekdays, excluding federal holidays.

• A standing agenda must be used, to include key cost, schedule, technical updates, as well as updates on ad hoc communications between the USG and the Contractor.

• No meeting minutes are required

• Contractor must provide bulleted email updates following any call or in lieu of a call by 2:00PM ET for that day.

Upon request of the Government, check-ins may also occur on weekends and on federal holidays, provided at least 24 hours’ notice.

Periodic Review Meetings

At the discretion of the Government, the Contractor must hold up to four per year recurring Project Review Meetings, held by teleconference or face-to face either in Washington, D.C. or at work sites of the Contractor or sub-contractors. Face-to-face meetings shall alternate between Washington, D.C. and Contractor, sub-contractor sites.