75A50125R00001 RADNUC Solicitation.docx

SOLICITATION, OFFER AND AWARD

1. THIS CONTRACT IS A RATED ORDER RATING

UNDER DPAS (15 CFR 7900)

PAGE OF PAGES

75A50125R00001

4. TYPE OF SOLICITATION SEALED BID (IFB)

NEGOTIATED (RFP)

5. DATE ISSUED

11/4/2024

6. REQUISITION/PURCHASE NUMBER

HHS / ASPR / DAAPPO / BARDA DCMA

O'NEILL HOUSE OFFICE BLDG, WASHINGTON, DC 20515

NOTE: In sealed bid solicitations "offer" and "offeror" mean "bid" and "bidder".

SOLICITATION

(Hour) (Date) CAUTION - LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

10. FOR INFORMATION

CALL:

A. NAME

Richard Hall

Richard.Hall@hhs.gov

EXT.

11. TABLE OF CONTENTS

X

OFFER (Must be fully completed by offeror) NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

12. In compliance with the above, the undersigned agrees, if this offer is accepted within 120 calendar days (60 calendar days unless a different period is inserted by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the set opposite each item, delivered at the designated point(s), within the time specified in the schedule.

13. DISCOUNT FOR PROMPT PAYMENT

(See Section I, Clause No. 52.232-8)

14. ACKNOWLEDGMENT OF AMENDMENTS

(The offeror acknowledges receipt of amendments to the SOLICITATION for offerors and related documents numbered and dated):

15A. NAME AND ADDRESS OF OFFER- OR

CODE

FACILITY

16. NAME AND THE TITLE OF PERSON AUTHORIZED TO SIGN OFFER

(Type or print)

AWARD (To be completed by Government)

(4 copies unless otherwise specified)

(Signature of Contracting Officer)

28. AWARD DATE

IMPORTANT - Award will be made on this Form, or on Standard Form 26, or by other authorized official written notice. AUTHORIZED FOR LOCAL REPRODUCTION Previous edition is unusable

STANDARD FORM1 33 (REV,. 9-97)

Prescribed by GSA - Far (48 CFR) 53.214 (c)

NOTE TO OFFERORS

The information in SECTION A - Solicitation/Contract Form, contains important information for any Offeror interested in responding to this solicitation. Any contract resulting from this solicitation will include in its SECTION A - Solicitation/Contract Form, accounting, appropriation, and general information applicable to the contract award.

If your proposal is not received by the Contracting Officer (CO) or his/her designee at the time and place specified, it will be considered late and handled in accordance with the Federal Acquisition Regulation (FAR), FAR 52.215-1 (Instructions to Offerors – Competitive Acquisition), the Health and Human Services Acquisition Regulation (HHSAR), and HHSAR Clause 352.215-70, “Late Proposals and Revisions” located in Section I of this solicitation.

Potential Offerors must be registered in the System for Award Management (SAM) prior to the award of a contract.

The contract schedule, outlined in SECTIONS B through H, contains contractual information pertinent to this solicitation. It is not an exact representation of the contract document that may be awarded as a result of this solicitation. The contract cost or price and other contractual provisions unique to the Offeror's proposal may be included in the resultant contract.

The contract schedule is intended to provide the Offeror with information to aid in understanding the likely terms and conditions of any resultant contract.

The cutoff date for all questions on this Request for Proposal (RFP) is January 3, 2025, at Noon EST. All questions must be submitted via e-mail to Audrey.Glover@hhs.gov and Joann.Kambaja@hhs.gov by December 13, 2025, at Noon EST.

PART I – THE SCHEDULE

SECTION B – SUPPLIES OR SERVICE AND PRICE / COST

B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The mission of the Biomedical Advanced Research and Development Authority (BARDA), an organization within the Administration for Strategic Preparedness and Response (ASPR) in the US Department of Health and Human Services (HHS), is to develop medical countermeasures (MCMs) that address the public health and medical consequences of chemical, biological, radiological, and nuclear (CBRN) accidents, incidents, and attacks; pandemic influenza; and emerging infectious diseases.

BARDA has identified a need to develop standardized radiation dosimetry guidelines for nonclinical models used by research institutions across the BARDA radiation research portfolio. Standardized guidelines leading to dosimetry harmonization across the portfolio are necessary to ensure consistent, accurate data and to facilitate comparison across studies.

BARDA is interested in harmonizing radiation dosimetry methodology across the BARDA radiation research portfolio. BARDA is particularly interested in developing source-independent, standardized dosimetry methods to facilitate harmonization across institutions that collaborate with BARDA on MCM development.

B.2. PRICES / COSTS

The final contract will contain the price/cost provisions agreed upon by the Government and the Offeror. It is anticipated that the total contract period of performance (base plus option periods) will be up to 5 years. The base period and options contract line-item number (CLIN) will be cost-plus-fixed-fee (CPFF) to develop standardization radiation dosimetry guidelines for nonclinical models

Option periods may be exercised within the base period of the contract if needed. Below are the anticipated CLINs.

B.2.1. BASE PERIOD

Base Period Cost-Plus-Fixed-Fee CLIN

B.2.2. OPTION PERIODS

1. The Government may exercise Option Period as set forth in ARTICLE I.3 of the contract.

2. Unless the government exercises its option pursuant to the option clause contained in ARTICLE I.3, the contract consists only of the Base Work segment specified in the Statement of Work, for the price set forth in ARTICLE B.2.1 of the contract.

3. The Government may modify the contract unilaterally and require the contractor to provide supplies and services for Option Periods listed below, in accordance with ARTICLE I.3.

4. If the Government decides to exercise an option(s), the Government will provide the Contractor a preliminary written notice of its intent as referenced in the applicable clause. Specific information regarding the timeframe for this notice is set forth in Article I.3 of this contract. The estimated cost of the contract will be increased as set forth below:

Optional Cost-Plus-Fixed-Fee CLINs

B.2.3. ADVANCE UNDERSTANDINGS

The final contract may contain advance understandings between the Government and the Offeror. Specific elements of cost, which normally require prior written approval of the Contracting Officer (CO) before the incurrence of the cost, will be included in this Section if the Contracting Officer has granted his/her approval prior to contract award.

B.2.4. PROVISIONS TO APPLICABLE COSTS

This section prohibits or restricts the use of contract funds, which includes the following items (costs unallowable unless otherwise approved by the Contracting Officer):

a) Acquisition, by purchase or lease, of any interest in real property;

b) Rearrangement or alteration of facilities;

c) Purchase of lease of any item of general-purpose office furniture or office equipment regardless of dollar value;

d) Accountable Government Property;

e) Overtime

f) General scientific meetings/conferences;

g) Travel costs that include foreign travel;

h) Costs incurred in the performance of any cost-reimbursement type subcontract (including consulting agreements);

i) Costs to be paid for the performance of a fixed-price subcontract that exceeds $250,000.00;

j) Refreshments and Meal Expenditures;

k) Promotional Items

l) Printing

SECTION C – DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

1.1. STATEMENT OF OBJECTIVES

1. BACKGROUND AND INTRODUCTION

The mission of the Biomedical Advanced Research and Development Authority (BARDA), an organization within the Administration for Strategic Preparedness and Response (ASPR) in the US Department of Health and Human Services (HHS), is to develop medical countermeasures (MCMs) that address the public health and medical consequences of chemical, biological, radiological, and nuclear (CBRN) accidents, incidents, and attacks; pandemic influenza; and emerging infectious diseases.

BARDA has identified a need to develop standardized radiation dosimetry guidelines for nonclinical models used by research institutions across the Radiological and Nuclear Countermeasures (RadNuc) radiation research portfolio. Standardized guidelines leading to dosimetry harmonization across the portfolio are necessary to ensure consistent, accurate data and to facilitate comparison across studies.

BARDA is interested in launching an effort to harmonize radiation dosimetry methodology across the BARDA radiation research portfolio. BARDA is particularly interested in developing source-independent, standardized dosimetry methods to facilitate harmonization across institutions that collaborate with BARDA on MCM development.

The Radiological and Nuclear Countermeasures Program (RNCP) at the National Institute for Allergy and Infectious Disease (NIAID) began to utilize a similar service in 2019 for small animal models. It announced a new award in January 2024, to continue this service. Since BARDA’s MCM projects are subject to the Animal Rule, the ability to fabricate phantoms is necessary to ensure dosimetry is standardized regardless of animal species. Responses received from a request for information (RFI) issued by BARDA in 2023 indicated that a single facility may not be ideally equipped to perform both the dosimetry standardization and phantom fabrication services. Therefore, BARDA has determined that phantom fabrication shall be a separate contract line-item number to facilitate subcontracting of these services, if necessary.

One cost-reimbursable type contract will be awarded to an organization to develop and fabricate phantoms for animal models, if necessary, and to assess, evaluate, monitor, and harmonize dosimetry across BARDA’s animal radiation research portfolio. The base period of performance for this contract will be two years with six 1-year options for a maximum period of performance period of five years. This duration will coincide with the RadNuc Non-clinical Development Task Order Indefinite Delivery, Indefinite Quantity (IDIQ) contracts. This duration will also allow the continuation of capabilities for use with future awards for RadNuc MCM development efforts. This contract will not provide funds to support pre-clinical animal studies or human research. BARDA will select projects to be assessed for dosimetry assessment from within the RadNuc-funded portfolio that includes industry, academia, and other government agencies.

2. SCOPE

The Contractor shall provide the capacity and capability needed to maintain, update, and refine a centralized dosimetry harmonization program that will be implemented at BARDA-funded institutions for RadNuc MCM development. This will include the following elements:

a) Protocol development for irradiator assessment and calibration

b) On-site and/or remote irradiator assessments for institutions funded by BARDA to conduct animal radiation research

c) Development and fabrication of phantoms as necessary to accomplish irradiator assessments In order to meet this scope, the objectives are outlined in the following sections:

Section 3: Technical Requirements Section 4: Facilities, Equipment, and Other Resources Section 5: Project Management Section 6: Options and Contract Line-Item Numbers (CLINs) Section 7: Deliverables Section 8: Delivery Schedule

3. TECHNICAL REQUIREMENTS

3.1. Independently, and not as an agent of the United States Government (USG), the Contractor shall furnish all the necessary services, qualified personnel, materials, supplies, equipment, facilities, transportation, and travel not otherwise specified by the USG as required to fulfill the programmatic objectives.

3.2. Minimum Specifications: The USG is seeking a technical solution that meets the following minimum specifications and outcomes:

3.2.1. Compile a catalog of phantoms available or for fabrication that represents the variety of small and large animal dimensions used in the radiation models. The phantoms may include phantoms developed by the Contractor before the award. The catalog must include any relevant specifications including the methods used to validate the phantom. The catalog shall be updated whenever a new phantom is available. Design files and other elements of the intellectual property that are not necessary to use or validate a phantom do not need to be included in the catalog. Determinations of necessity will be made at the discretion of the RadNuc Contracting Officer’s Representative (COR) to protect the Contractor’s intellectual property.

3.2.2. Develop new phantoms as needed to support animal radiation experiments in the RadNuc portfolio. These shall be appropriate for the following species at a minimum: mouse, rat, rabbit, minipig, and any necessary non-human primates (NHPs). If an animal phantom is necessary that is not feasible for development or fabrication, the Contractor shall communicate the challenges with the COR promptly to ensure delays in phantom development do not stall animal experiments.

3.2.3. Fabricate phantoms from the catalog at the request of the COR or as needed for irradiator assessment.

3.2.4. Establish an inventory of radiators for evaluation within the first quarter of the contract. This inventory shall comprise detailed information on the irradiators utilized by institutions within the BARDA/RadNuc-funded portfolio that the COR has identified to participate in the dosimetry harmonization initiative. Information on any recent calibrations and dosimetry assessments should also be included. This inventory shall be updated upon notification from the COR when new institutions are added to the RadNuc portfolio.

3.2.5. Prepare a schedule of radiator assessments and discuss with the COR whether an on-site assessment is needed or whether a documentary review of prior calibration and dosimetry assessments would suffice.

3.2.6. Conduct baseline evaluations of each RadNuc-selected irradiator using the provided phantom(s) and/or appropriate dosimetry methodology to determine radiation dose accuracy and field homogeneity. The Contractor shall submit a draft protocol for the baseline evaluations to the COR for review and comments before initiating the evaluations.

3.2.7. Review dosimetry records from each participating institution to assess if the radiation dose accuracy and field homogeneity are within an acceptable tolerance and determine the necessity of additional assessment.

3.2.8. Work remotely with staff (radiation physicists and technicians), as determined by the Contract Officer (CO) under the advisement of the COR, at each participating institution to identify any modifications needed to improve the accuracy of radiation exposures based on data obtained in the baseline evaluations, and to identify specific issues or concerns that may be affecting radiation dose uniformity. These may include but are not limited to energy settings, filter use, jig suitability, dosimeter use, phantom selection, irradiator field mapping, and staff training. Uniform dosimetry measurements shall be within 2% variance from the expected radiation dose. If a 2% variance cannot be reasonably achieved, the COR will determine if a larger variance is acceptable and discuss any appropriate remedies with the Contractor and the participating institution.

3.2.9. Conduct on-site evaluations as necessary to work with the designated institutions to develop strategies that may require the phantom Contractor to develop specialized phantoms suitable for the institution’s needs if harmonized phantoms cannot be used, and/or to evaluate irradiator beam characteristics, and conduct irradiator field mapping studies, as directed by the COR.

3.2.10. Document each participating institution’s established guidelines for measuring dosimetry, calibration, and maintenance of their irradiator(s) and develop quantifiable data demonstrating accurate determination of radiological exposure in tissues.

3.2.11. Determine if follow-up assessments are necessary for each participating institution and document the recommended frequency of re-assessment, with COR approval.

4. Facilities, Equipment, and Other Resources

4.1. A radiation facility that is consistent with accepted dosimetry standards

4.2. Phantom manufacturing capabilities to develop and fabricate phantoms as needed

4.3. All other tools and devices necessary to conduct dosimetry and radiation characterization assessments/evaluations for radiation sources used in pre-clinical radiobiological studies

5. Project Management

5.1. The Contractor will oversee the management of contract and subcontract requirements that include communication with institutions participating in the dosimetry harmonization program. The Contractor shall:

5.1.1. Conduct periodic teleconferences with the COR and Contractor key personnel.

5.1.2. Prepare agendas, write minutes and summaries for meetings, and action plan items

5.1.3. Prepare progress reports

5.1.4. Develop SOPs, as needed.

5.2. Within 30 days of contract award, the Contractor shall submit a Project Management Plan that includes the following information:

5.2.1. Drafting and finalizing quarterly and annual reports for submission to the BARDA COR, including a final report at the end of the contract.

5.2.2. Drafting minutes after periodic teleconferences with BARDA (dates to be arranged between BARDA and Contractor)

5.2.3. Planning and execution of any major meetings such as the kickoff and annual meetings with BARDA

5.2.4. Drafting and finalizing SOPs with participating institutions (dosimetry harmonization contract only)

6. Options and Contract Line-Item Numbers (CLINs)

6.1. This contract will have a 2-year base period with three 1-year options, for a total performance period of 5 years.

6.2. The base period and each option will include two CLINS: one for irradiator assessment and one for phantom development and fabrication, as needed.

7. Deliverables

7.1. General Deliverables

7.1.1. Catalog of available phantoms

7.1.2. Phantoms appropriate for requested animal models

7.1.3. Inventory of irradiators used in BARDA-funded animal irradiation experiments

7.1.4. SOPs for each irradiator type identified in 7.1.3

7.1.5. Documentation of each participating institution’s assessments

7.2. Periodic Teleconferences

7.2.1. Draft bulleted agenda provided 48 hours before a teleconference

7.2.2. Meeting minutes provided five days after teleconference

7.3. Quarterly Reports

7.3.1. Reports shall describe the progress of meeting contract milestones - broken out by subtasks within each milestone, overall project assessment, problems encountered, and recommended solutions.

7.3.2. Reports shall detail the planned progress and actual progress during the period covered, explaining occurrences of any differences and corrective steps/actions planned if behind schedule.

7.3.3. Reports shall detail estimated and actual expenses, including a narrative of whether there is any discrepancy between % work completed and cumulative costs incurred to date. This section of the report shall 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 shall be included.

7.3.4. Reports shall include an updated Gantt.

7.4. Draft Final Report: A draft final report shall be provided for BARDA review and comment. The report shall summarize all work conducted during the period of performance and provide all results (include specific items required in the report).

7.5. Final Report: The Final Report shall address BARDA's comments regarding the draft report.

7.6. Technical Deliverables: For each Task, technical deliverables include:

7.6.1. Gantt Chart

7.6.2. Interim data, where applicable

7.6.3. Quality Assurance Project Plan. The plan should cover each study conducted and demonstrate how risks to data quality and integrity as identified by the Offeror will be mitigated by the Offeror’s quality systems.

7.6.4. Draft Study Reports: At the time of submission to BARDA, a Draft Study Report must include all components of the Final Study Report and have passed internal Quality Control review. This document should be considered a “draft” only in terms of requiring BARDA review. The Draft Report is due 30 days after the completion of a radiator dosimetry evaluation.

7.6.5. Final Study Report: The report will be considered final only when all BARDA comments have been addressed. The report is inclusive of all raw data files,

7.6.6. Data Package/eReadable Raw Data files.

SECTION D – PACKAGING, MARKING AND SHIPPING

D.1. METHOD OF DELIVERY

Unless otherwise specified by the Contracting Officer, all deliverable items to be furnished to the Government under this contract (including invoices) shall be made by first class mail, overnight carrier, or email as described in SECTION F.3.

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

D.2. FOB DESTINATION DELIVERIES

The Offeror shall describe the storage conditions for each product, specifically noting the acceptable temperature range required to maintain product quality. The Offeror shall be responsible for maintaining product temperature control until the product(s) arrives at the ASPR/SNS and has completed product acceptance by the USG. The Offeror shall provide the Government with an ambient exposure letter that covers the time the product(s) leaves the Offeror’s validated storage facility until arrival at the ASPR SNS. 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 Offeror will provide and place TempTale(s) on each pallet of the product while the product is inside the Offeror’s validated storage facility 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).

SECTION E – INSPECTION AND ACCEPTANCE

E.1. INSPECTION AND ACCEPTANCE

Inspection and acceptance of the product, services, and documentation called for herein shall be accomplished by the Contracting Officer or a duly authorized representative. Technical inspection and acceptance will take place at:

Biomedical Advanced Research and Development Authority Administration for Strategic Preparedness and Response 200 C Street, S.W.

Washington, D.C. 20024

Acceptance may be presumed unless otherwise indicated in writing by the Contracting Officer or the duty-authorized representative within 30 days of receipt.

E.2. FEDERAL ACQUISITION REGULATION CLAUSES INCORPORATED BY REFERENCE

This contract incorporates the following clause by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available.

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. PERIOD OF PERFORMANCE

The period of performance of this contract (base plus option periods) is anticipated for up to 5 years from the date of award. CLINs within the period of performance are set forth in SECTION B.

F.2. DELIVERIES

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.

F.3. CONTRACT DELIVERABLES AND REPORTING REQUIREMENTS

F.3.1. Submission of Contract Deliverables

Documents shall be delivered electronically via email to the CO and the COR. Additionally, the Contractor shall upload documents to the appropriate Government designated file sharing system. The Government shall provide two contractor representatives with authorized log-in access to the file share program. Each representative must complete mandatory training provided by the Government prior to gaining user access. A notification email shall be sent to the CO and COR upon electronic delivery of any documents.

F.3.2. Reporting Requirements

In addition to those reports required by other terms of this RFP, the Offeror shall submit to the CO and the COR technical progress reports as identified in any potential resultant contract. These reports shall be subject to the technical inspection and requests for clarification by the COR, and approval by the CO/COR. These reports shall be brief, factual, and prepared in accordance with the following format:

A. Monthly Progress Report

This report shall include a description of the activities during the reporting period and the activities planned for the ensuing reporting period. The first reporting period consists of the first full month of performance plus any fractional part of the initial month. Thereafter, the reporting period shall consist of each calendar month.

The Offeror shall submit a Monthly Progress Report on or before the 15th calendar day following the last day of each reporting period and shall include the following:

Title Page: The title page for this report shall include the contract number and title; the type of report and period that it covers; the Offeror's name, address, telephone number, fax number, and e-mail address; and the date of submission.

Distribution List: A list of individuals receiving the Technical Progress report.

Progress:

SECTION I – An introduction covering the purpose and scope of the contract effort.

SECTION II Part A: SUMMARY – A description or table summarizing ongoing activities.

SECTION II Part B: MANAGEMENT AND ADMINISTRATIVE UPDATE – This section shall include a description of all meetings, conference calls, etc. that have taken place during the reporting period. Include progress on administration and management issues (e.g. evaluating and managing subcontractor performance and personnel changes). Include all Quality Management System, Quality Control, and Quality Assurance Plans as part of this report or as requested by the COR.

SECTION II Part C: TECHNICAL PROGRESS – This section shall document the results of work completed and costs incurred during the period covered in relation to the proposed progress, effort, and budget. The report shall be in sufficient detail to explain comprehensively the results achieved.

SECTION II Part D: ISSUES – This section shall 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; and if a project activity is delinquent, then what corrective action steps are planned. Revised timelines shall be provided.

SECTION II Part E: PROPOSED WORK – This section shall include a summary of work proposed as a rolling three-month forecast for the next reporting period, by a certain date, and by whom.

SECTION II Part F: MANUFACTURING AND SUPPLY CHAIN MANAGEMENT – This section shall include a summary of the manufacturing and supply-chain-related activities. Also included in this section are updates to the production plan, capacity projections, stability results, inventory, and shipment/distribution information.

SECTION II Part G: CONTRACTING OFFICER APPROVALS – This section shall include a table indicating each Contracting Officer Approval (COA) request, its current status (e.g., date submitted, date approved, date returned), amount requested, and the vendor for which the COA authorizes subcontracted work to be performed.

Invoices: Summary of any invoices submitted during the reporting period.

A Monthly Progress Report will not be required in the same month Annual Progress Reports, or a Final Report are due.

B. Annual Progress Report

This report shall include a summation of the activities during the reporting period, and the activities planned for the ensuing reporting period. The first reporting period consists of the first full year of performance plus any fractional part of the initial year. Thereafter, the reporting period shall consist of each calendar year.

The Offeror shall submit an Annual Progress Report on or before the 30th calendar day following the last day of each reporting period and shall include the following:

Title Page: The title page for this report shall include the contract number and title; the type of report and period that it covers; the Offeror's name, address, telephone number, fax number, and e-mail address; and the date of submission.

Distribution List: A list of individuals receiving the Technical Progress report.

Progress:

SECTION I – An introduction covering the purpose and scope of the contract effort.

SECTION II Part A: SUMMARY – A description or table summarizing ongoing activities.

SECTION II Part B: MANAGEMENT AND ADMINISTRATIVE UPDATE – This section shall include a description of all meetings, conference calls, etc. that have taken place during the reporting period. Include progress on administration and management issues (e.g., evaluating and managing subcontractor performance and personnel changes). Include all Quality Management System, Quality Control, and Quality Assurance Plans as part of this report or as requested by the COR.

SECTION II Part C: TECHNICAL PROGRESS – This section shall document the results of work completed and costs incurred during the period covered in relation to the proposed progress, effort, and budget. The report shall be in sufficient detail to explain comprehensively the results achieved.

SECTION II Part D: ISSUES – This section shall 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; and if a project activity is delinquent, then what corrective action steps are planned. Revised timelines shall be provided.

SECTION II Part E: PROPOSED WORK – This section shall include a summary of work proposed as a rolling three-month forecast for the next reporting period, by a certain date, and by whom.

SECTION II Part F: MANUFACTURING AND SUPPLY CHAIN MANAGEMENT – This section shall include a summary of the manufacturing and supply-chain-related activities. Also included in this section are updates to the production plan, capacity projections, stability results, inventory, and shipment/distribution information.

SECTION II Part G: CONTRACTING OFFICER APPROVALS – This section shall include a table indicating each COA request, its current status (e.g., date submitted, date approved, date returned), amount requested, and the vendor for which the COA authorizes subcontracted work to be performed.

Invoices: Summary of any invoices submitted during the reporting period.

An Annual Progress Report will not be required for the period when the Final Technical Progress Report is due.

C. Draft Final Report and Final Report

These reports include a summation of the work performed and results obtained for the execution of various studies or technical work packages during the entire contract period of performance. This report shall be in sufficient detail to describe comprehensively the results achieved. The Draft Final Progress Report shall be due 45 calendar days prior to the expiration date of the contract and the Final Progress Report is due before the expiration date of the contract. The report shall conform to the following format:

Title Page: The title for these reports shall include the contract number and title; the type of report and period that it covers; the Offeror's name, address, telephone number, fax number, and e-mail address; and the date of submission.

Distribution List: A list of individuals receiving the Technical Progress report.

Progress:

SECTION I: EXECUTIVE SUMMARY – Summarize the purpose and scope of the contract effort including a summary of the major accomplishments relative to the specific activities set forth in the Statement of Work.

SECTION II: RESULTS – A detailed description of the work performed, and the results obtained including all expenses for the entire contract period of performance.

D. FDA Regulatory Agency Correspondence, Meeting Summaries, and Submissions

a) Within five business days of any formal meeting with the FDA or other regulatory agency, the Offeror shall forward the initial draft minutes to the COR. The Offeror shall forward the final minutes when available.

b) Within five business days of any informal meeting with the FDA or other regulatory agency, the Offeror shall forward the initial draft minutes to the COR. The Offeror shall forward the final minutes when available and if applicable.

c) The Offeror shall forward the dates and times of any meeting with the FDA and other regulatory agencies to the COR as soon as the meeting times are known and make arrangements for appropriate BARDA staff to attend the meetings.

d) The Offeror shall provide the COR the opportunity to review and comment upon any documents to be submitted to the FDA or other regulatory agency. The Offeror shall provide the COR with five business days in which to review and provide comments back to the Offeror prior to the Offeror’s submission to the FDA.

e) The Offeror shall forward Standard Operating Procedures (SOPs) upon request from the COR.

f) The Offeror shall provide raw data and specific analysis of data generated with USG funds upon request from the COR.

g) The Offeror shall notify the COR and CO within 24 hours of all FDA arrivals to conduct site visits/audits by any regulatory agency. The Offeror shall provide the USG with an exact copy (non-redacted) of the FDA Form 483 and the Establishment Inspection Report (EIR). The Offeror shall provide the COR and CO copies of the plan for addressing areas of non-conformance to FDA regulations for GLP guidelines as identified in the audit report, status updates during the plan execution, and a copy of all final responses to the FDA. The Offeror shall also provide redacted copies of any FDA audits received from the sub-contractor that occur as a result of this contract or for this product. The redactions shall be limited to issues that are unrelated to the subcontractor’s performance on any award made under this RFP. The Offeror shall make arrangements with the COR for the appropriate BARDA representative(s) to be present during the final debrief by the regulatory inspector.

E. Other Requirements/Deliverables

1. Integrated Master Project Plan The Offeror shall provide an Integrated Master Project Plan (including tabular and Gantt forms) to the COR that indicates the critical path to annual deliverables and Work Breakdown Structure (WBS) elements. Attention shall be placed on providing sufficient turnaround time for the USG (BARDA, FDA, and ASPR) for the review of critical documentation. The Offeror shall integrate to demonstrate interdependencies among all CLINs. The Integrated Master Project Plan shall be incorporated into any potential contract and will be used to monitor the performance of the contract. This report shall be due within 90 days of contract award. Updates shall be due as requested by the COR.

I. Critical Path Milestones The Integrated Master Project Plan shall outline key, critical path milestones, with “Go/No Go” decision criteria (entrance and exit criteria for each phase of the project). This report shall be due within 90 days of contract award. Updates shall be due as requested by the COR.

II. Work Breakdown Structure The WBS shall be discernable and consistent. The COR may require the Offeror to furnish WBS data at the work package level or at a lower level if there is significant complexity and risk associated with the task. This report shall be due within 90 days of contract award. Updates shall be due as requested by the COR.

III. Risk Mitigation Plan/Matrix The Offeror shall develop and maintain a risk management plan that highlights potential problems or issues that may arise during the life of the contract, their impact on cost, schedule, and performance, and appropriate remediation plans. This plan shall reference relevant WBS/SOW elements where appropriate. The USG has provided a Risk Mitigation Matrix template (See http://www.phe.gov/about/amcg/contracts/Pages/toolkit.aspx) to be completed by any prospective Offeror. This report shall be due within 90 days of contract award. Updates shall be due as requested by the COR.

2. Technology Packages

Technology packages developed under the contract that include complete protocols must be submitted at the request of the COR. See FAR clauses 52.227-11, Patent Rights- Ownership by the Offeror, and 52.227-14, Rights in Data. This report shall be due upon request from the COR.

3. Experimental Protocols

The Offeror shall submit to the COR all study/experiment/test plans, designs, and protocols prior to execution for approval or upon request by the COR when required.

4. Annual/Final Invention Report

All reports and documentation required by FAR Clause 52.227-11, Patent Rights- Ownership by the Offeror, including, but not limited to, the invention disclosure report, the confirmatory license, and the Government support certification. An Annual Invention Report shall be due on or before the 30th calendar day after the completion of each reporting period. A Final Invention Report (see FAR 27.303 (b)(2)(ii)) shall be due on or before the expiration date of the contract. If no invention is disclosed or no activity has occurred on a previously disclosed invention during the applicable reporting period, a negative report shall be submitted to the CO.

5. Publications

Any manuscript or scientific meeting abstract containing data generated under this contract must be submitted to COR for review prior to submission. Reports shall be due within 30 calendar days for manuscripts and 15 calendar days for abstracts.

6. Press Releases

The Offeror agrees to accurately and factually represent the work conducted under this contract in all press releases. The Offeror shall ensure the Contracting Officer has received and approved an advanced copy of any press release not less than five business days prior to the issuance of any potential press release.

7. Security Report

The Offeror shall report to the government any activity; or incident that violates established security standards; or indicates the loss or theft of government products. Reports shall be due within 24 hours after the occurrence of an activity or incident.

8. Security Plan

The Offeror shall submit a Final Security plan within 90 days of contract award. See Attachments 15 and 16 for security requirements and a template for the Security Plan.

9. Quality Management System Plan

The Offeror shall submit to the COR a Quality Management System Plan for approval no later than 90 days from the date of award.

10. Manufacturing Plan

The Offeror shall submit to the COR a comprehensive manufacturing plan for review and approval no later than 90 days from the date of award.

F.4. DELIVERABLE SCHEDULE

COR: (1) electronic copy Meeting minutes are due no later than five business days following each meeting.

COR: (1) electronic copy Reports are due on or before the 15th of each month following the end of each reporting period.

COR: (1) electronic copy Reports are due on or before the 30th calendar day following the end of each reporting period.

COR: (1) electronic copy The report is due 45 Calendar days before the expiration date of the contract.

COR: (1) electronic copy The report is due no later than 30 calendar days before the expiration date of the contract.

- Critical Path Milestones

· Work Breakdown Structure

- Risk Mitigation Plan/Matrix CO: (1) electronic copy COR: (1) electronic copy The report is due within 90 days of contract award. Updates are due as requested by the COR.

COR: (1) electronic copy Upon request from the COR.

COR: (1) electronic copy Reports are due within 30 calendar days for manuscripts and 15 calendar days for abstracts.

COR: (1) electronic copy Reports are due within 24 hours after the occurrence of an activity or incident.

COR: (1) electronic copy Final plan due within 30 days of contract award.

F.5. FEDERAL ACQUISITION REGULATION CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY 1998)

This contract incorporates the following clause(s) by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available. The full text of each clause may be accessed electronically at this address: http://www.acquisition.gov/comp/far/index.html.

SECTION G – CONTRACT ADMINISTRATION

G.1. CONTRACTING OFFICER (CO)

The Contracting Officer is the only individual who can legally commit and bind the Government to the expenditure of public funds. No person other than the CO can make any changes to the terms, conditions, general provisions, or other stipulations of this contract. Any other commitment, either explicit or implied, is invalid.

The CO is the only person with authority to act as an agent of the Government under this contract. Only the CO has the authority to (1) direct or negotiate any changes in the statement of objectives; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Offeror for any costs incurred during the performance of this contract; (5) obligate or de-obligate funds into the contract; (6) sign written licensing agreements; or (7) otherwise change any terms and conditions of this contract.

No information, other than that which may be contained in an authorized modification to this contract duly issued by the CO, which may be received from any person employed by the United States Government, or otherwise, shall be considered grounds for deviation from any stipulation of this contract.

G.2. CONTRACTING OFFICER’S REPRESENTATIVE (COR)

The Government's Contracting Officer’s Representative is: To be identified at the time of contract award.

As delegated by the CO, the COR is responsible for (1) monitoring the Offeror's technical progress, including the surveillance and assessment of performance and recommending to the CO changes in requirements; (2) assisting the CO in interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections required by this contract; and (5) assisting in the resolution of technical problems encountered during the performance.

G.3. OFFEROR’S POINTS OF CONTACT

The Offeror shall provide primary and secondary points of contact that will be available 24 hours per day, 7 days per week, to be notified in case of a public health emergency.

G.4. KEY PERSONNEL, HHSAR 352.237-75 (December 2015)

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to the Offeror voluntarily diverting any of the specified individuals to other programs or contracts the Offeror shall notify the CO and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract (including, when applicable, Human Subjects Testing requirements). If the employee of the Offeror is terminated for cause or separates from the Offeror voluntarily with less than 30 days’ notice, the Offeror shall provide the maximum notice practicable under the circumstances. The Offeror shall not divert, replace, or announce any such change to key personnel without the written consent of the CO. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.

The following individual(s) is/are considered to be Key Personnel to the work being performed hereunder:

G.5. INVOICE SUBMISSION – HHSAR 352.232-71 Electronic submission of payment requests Electronic Submission of Payment Requests (Feb 2022)

(a) Definitions. As used in this clause— (1) “Payment request” means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), “Content of Invoices” and the applicable Payment clause included in this contract.

(b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

(c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures.

(d) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer's written authorization with each payment request.

(End of Clause)

G.5.1 INVOICE ELEMENTS

1. The Contractor agrees to include (as a minimum) the following information on each invoice:

0. Contractor’s Name & Address

0. Contractor’s Tax Identification Number (TIN)

0. Contract Number

0. Invoice Number

0. Invoice Date

0. Contract Line-Item Number (CLIN)

0. Requisition number associated with each CLIN

0. Quantity

0. Unit Price & Extended Amount for each line item

0. Total Amount of Invoice

0. Name, title, and telephone number of person to be notified in the event of a defective invoice

0. Payment Address

1. The invoice shall be signed by a person authorized to bind the Contractor.

1. The Contractor shall not submit an invoice prior to delivery of goods or services.

1. The Contractor shall include the following certification at the bottom of the payment request: “I hereby certify that the salaries billed in this payment request are in compliance with the current HHS Salary Rate Limitation Provisions in Section I of the contract.”

G.5.2 ELECTRONIC INVOICING AND PAYMENT REQUIREMENTS – INVOICE PROCESSING PLATFORM (IPP)

· All Invoice submissions for goods and or services delivered to facilitate payments must be made electronically through the U.S. Department of Treasury’s Invoice Processing Platform System (IPP).

· Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in the applicable Prompt Payment clause…