RFP for 2PAM AutoInjectors.pdf

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 award of a contract.

The contract schedule, set forth 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 RFP is July 21, 2022 at 12PM ET. All questions shall be submitted via e-mail to Jennifer.taranto@hhs.gov. The due date for all proposal submissions is August 15, 2022 at 2PM ET. All proposals must be submitted via email to Jonathan.Gonzalez@hhs.gov and Jennifer.Taranto@hhs.gov. The submission email must include business and technical proposal documents as separate documents.

mailto:Jennifer.taranto@hhs.gov mailto:Jonathan.Gonzalez@hhs.gov mailto:Jennifer.Taranto@hhs.gov

SECTION B – SUPPLIES OR SERVICE AND PRICE / COST

B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

This acquisition will allow BARDA to invest Project Bioshield funds for late-stage clinical development, regulatory approval for 2-PAM autoinjectors (as a drug/device combination product) to treat organophosphate (OP) poisoning, including nerve agents, in adult and pediatric populations, and procurement of 2-PAM autoinjectors for the SNS/CHEMPACK Program.

B.2. PERIOD OF PERFORMANCE

The final contract will contain the price/cost provisions agreed upon by the Government and the Offeror. It is anticipated that the final contract will consist of a base period of performance up to three (3) years and a total contract period of performance (base plus option periods) up to 7 years with the exercise of options.

B.2.1. BASE PERIOD CLINs

Anticipated

Period of Performance

CLIN

Type Quantity Supplies/Services

2022-2025 (Base Period) 0001 Cost Plus Fixed

Fee N/A

• Program Management

• Development/Finalization of Adult Device to achieve Reliability Requirements (99.999%)

• Consistency Lot Manufacturing and Stability

• Manufacturing Validation Lots (PPQ) (May be combined with Consistency or Procurement – Dependent on Schedule)

• Human factors studies for devices for adult and pediatrics

• Regulatory activities to support FDA approval of drug/device combination for 2PAM autoinjectors to treat Organophosphorus (OP) Poisoning, Including Nerve Agents, pediatric and adult populations

2022-2025

(Base Period) 0002 Firm Fixed Price 309,000 Procurement of Adult Dose Autoinjector Devices

B.2.2. OPTION PERIOD CLINs

Option 1: 2025 – 2027 Option 2: 2027 – 2029

Anticipated

Period of Performance

CLIN

Type Quantity Supplies/Services

2025-2027 (Option 1) 0003 Cost Plus Fixed

Fee N/A Post-Market License Commitments

2025-2027 (Option 1) 0004 Firm Fixed Price 851,000 Procurement of Adult Dose Autoinjector Devices

2027-2029 (Option 2) 0005 Cost Plus Fixed

Fee N/A Post-Market License Commitments

2027 – 2029 (Option 2) 0006 Firm Fixed Price 850,000 Procurement of Adult Dose Autoinjector Devices

B.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 before incurrence of the cost will be included in this Section if the Contracting Officer has granted his/her approval prior to contract award.

a. Person-in-Plant

With seven (7) days advance notice to the Contractor in writing from the Contracting Officer, the Government may place a man-in-plant in the Contractor’s or Subcontractor’s facility, who shall be subject to the Contractor’s or Subcontractor’s policies and procedures regarding security and facility access at all times while in the Contractor’s or Subcontractor’s facility. The Government’s representative shall be provided reasonable access, during normal business hours, to the production areas being utilized in performance on the Contract. As determined by federal law, no Government representative shall publish, divulge, disclose, or make known in any manner, or to any extent not authorized by law, any information coming to him in the course of employment or official duties, while stationed in a contractor’s or subcontractor’s plant.

An article substantially similar to this Person-in-Plant article shall be incorporated into any subcontract for experimental or manufacturing work.

b. Security

A security plan with proposal submission is required for this effort.

c. Subcontracts

Prior written consent from the Contracting Officer in the form of Contracting Officer Authorization (COA) is required for any subcontract that:

• Is of the cost-reimbursement type and exceeds $250,000; or

• Is of the fixed price type and exceeds $250,000 or 5% of the contract, whichever is less.

The Contracting Officer shall request appropriate supporting documentation in order to review and determine authorization, pursuant with FAR Clause 52.244-2, Subcontracts.

After receiving written consent of the subcontract by the Contracting Officer, the Contractor shall provide a copy of the signed, executed subcontract and consulting agreement to the Contracting Officer within ten (10) calendar days.

Note: Consulting services are treated as subcontracts and subject to the ‘consent to subcontract’ provisions set forth in this Section.

d. Overtime Compensation

No overtime (premium) compensation is authorized under the subject contract.

e. Sharing of contract deliverables within United States Government (USG)

In an effort to build a robust medical countermeasure pipeline through increased collaboration, the Government may share technical deliverables with Government entities responsible for Medical Countermeasure Development. In accordance with recommendations from the Public Health Emergency Medical Countermeasure Enterprise Review, agreements established in the Integrated Portfolio Advisory Committee (PAC) Charter, and agreements between BARDA and the Department of Defense, the National Institutes of Health, the Centers for Disease Control, and the Food and Drug Administration, BARDA may share technical deliverables and test results created in the performance of this Contract with colleagues within the Integrated Portfolio.

This advanced understanding does not authorize the Government to share financial information outside of the United States Government. The Contractor is advised to review the terms of FAR 52.227-14, Rights in Data – General, regarding the government’s rights to deliverables submitted during performance as well as the government’s rights to data contained within those deliverables.

f. Approval of Human and Animal Protocols

The Contractor shall submit all human and animal protocols and human informed consent documents as referenced under this Contract to the COR for review and approval prior to seeking other approvals (Institutional Review Board, Human Use Committee, Institutional Animal Care and Use Committee) unless the contractor already had such approvals prior to contract award. The Government requires no fewer than eight (8) business days to perform a review. The Contractor shall take this review time into account and submit protocols as early as possible to avoid delays. The Government’s comments and feedback shall be addressed prior to approval. The COR will review and provide approval of protocols. Human informed consents shall also be submitted and reviewed with any human protocol.

g. Rights in Data

The contract will incorporate the FAR Clause 52.227-14, Rights in Data—General. The Contractor is advised to review the terms of FAR 52.227-14, Rights in Data, regarding the government’s rights to deliverables submitted during performance as well as the government’s rights to data contained within those deliverables. The contract will also include FAR Clause 52.227-16 Additional Data Requirements.

h. Invoice Submission during end of Fiscal Year

The government will not accept invoices for processing from Sep 6th through Oct 5th because of end of year fiscal requirements. Any invoices received from September 6th through October 5th will be canceled and returned to the Contractor for resubmission beginning on October 6th.

h.1. Travel Costs

a) Total expenditures for travel (transportation, lodging, subsistence, and incidental expenses) incurred in direct performance of this contract during the Base Period (CLIN 0001) shall not exceed $XXX (to be determined at the time of award) without the prior written approval of the Contracting Officer. Costs must be consistent with Federal Acquisition Regulations (FAR) 52.247-63 – Preference for U.S. Air Flag carriers.

b) Subject to the annual dollar limitation specified under B.4.b.1. above, the Contactor shall invoice and be reimbursed for all travel costs in accordance with Federal Acquisition Regulation (FAR) 31.2 – Contracts with Commercial Organizations, Sub-Section 31.205- 46, Travel Costs.

c) If foreign travel is necessary, a Contracting Officer Authorization (COA) will be required.

Expenditures for foreign travel (transportation, lodging, subsistence, and incidental expenses) incurred in direct performance of this contract shall not exceed the amount specified in each approved COA, without the prior written approval of the Contracting Officer. For an organization located outside Canada, the United States and its territories and possessions, foreign travel means travel outside that country. Foreign travel must be billed separately from domestic travel.

Requests for foreign travel must be submitted at least four weeks in advance and shall contain the following:

a. Meeting(s) and place(s) to be visited, with costs and dates; name(s) and title(s) of Contractor personnel to travel and their functions in the contract project;

b. Contract purposes to be served by the travel;

c. How travel of Contractor personnel will benefit and contribute to accomplishing the contract project, or will otherwise justify the expenditure of BARDA contract funds;

d. How such advantages justify the costs for travel and absence from the project of more than one person if such are suggested; and

e. What additional functions may be performed by the travelers to accomplish other purposes of the contract and thus further benefit the project.

Contractor Consent to Go/No-Go Decision

The Government’s discretion to exercise options for periods beyond the base period may only be exercised if Contractor and Government agree that the Milestones of the current base or option period(s) have been accomplished as detailed in GO/NO-GO DECISION POINTS. Following Contractor’s notification to the COR that all Milestones of the current base or option period(s) have been achieved, the Government may, at its sole discretion, exercise its right to award the next option period.

B.4 ORGANIZATIONAL CONFLICT OF INTEREST

a. General: For the purpose of this provision/clause, “consultant” is defined as a company, firm, LLC, sole proprietor, joint venture member, independent contractor, subcontractor, affiliate, or similar entity that is not an employee of the Contractor.

b. Disclosure: The Contractor shall report contacts with consultants who are paid to furnish advice, information, direction, or assistance to the Contractor or any subcontractor in support of the preparation or submission of the Contractor’s business or technical proposal. The report shall include the following information:

a. The name, title, and contact information for the consultant, including the name and contact information for his/her company/firm/etc.

b. The name, title, and contact information for a Contractor point of contact, including the name and contact information for the prime contractor if the consulting services were received by a subcontractor.

c. The nature of the consulting services received.

c. Resolution: The responsible Contracting Officer will review the Contractor’s disclosure to determine whether an actual or appearance of a conflict of interest exists based on the information disclosed by the Contractor and/or from other sources. The framework for the Contracting Officer’s review will be FAR Subpart 9.5, Organizational and Consultant Conflicts of Interest. If an actual or appearance of a conflict of interest exists, the Contracting officer will take action which may include, but is not limited to, requesting a mitigation plan from the Contractor.

B.5. 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 or 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 including 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

C.1. STATEMENT OF OBJECTIVES

BACKGROUND AND PURPOSE

This Request for Proposal (RFP) covers the advanced research and development, procurement, and delivery of Pralidoxime (2-pyridine aldoxime methyl chloride; 2-PAM) autoinjectors that have received FDA approval for the treatment of organophosphate (OP) poisoning, including nerve agents, in both adult and pediatric populations. Acceptance of the autoinjectors into the SNS/CHEMPACKs requires that the finished product meet all specifications and reliability requirements as determined by the FDA. The goal of this acquisition is to replace the 2-PAM autoinjectors held in the legacy Mark-1 kits in the Strategic National Stockpile’s (SNS) CHEMPACK Program with autoinjectors containing only 2- PAM for the flexibility of use in diverse civilian population for rapid intramuscular administration. 2- PAM autoinjectors would be used in the prehospital setting (EMS CHEMPACKs) and in the hospital setting in a mass casualty situation involving nerve agents to increase the ease and speed of administration. 2-PAM autoinjectors will be FDA approved for pediatric and adult populations.

Organophosphate or nerve agent poisoning requires intervention to occur quickly given the rapid onset of symptoms, which manifest within minutes, rather than hours. Pralidoxime (2-PAM) and atropine, an anticholinergic, must be administered as soon as possible. Both drugs should be available as far forward as practical, in a presentation that allows for ease of use in a mass casualty scenario. Intramuscular autoinjectors fulfil this requirement. Modern, FDA-approved, atropine autoinjectors are available, but there are currently no 2-PAM autoinjectors aside from those found in MARK-1™ kits, a legacy set of nerve-agent countermeasure autoinjectors currently stocked by SNS.

There is a requirement for SNS to stockpile a modern acetylcholinesterase reactivator (2-PAM, 600

mg) to complement existing atropine autoinjectors. These new 2-PAM (600 mg) autoinjectors would replace those held in the legacy Mark-1 kits. The military has moved toward use of a dual drug autoinjector (ATNAA/DuoDote®) that includes both atropine (2.1 mg) and 2-PAM (600 mg). Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) has determined that the needs of the SNS in treating a diverse civilian population would be better served by the flexibility of separate autoinjectors for the two drugs. Therefore, development and acquisition of 2-PAM (600mg) IM autoinjectors and their approval as a drug/device combination product for the treatment of organophosphate and nerve agent poisonings will fulfill the present requirement.

This acquisition will allow BARDA to invest Project Bioshield funds for late-stage clinical development and regulatory approval for 2-PAM autoinjectors (as a drug/device combination product) to treat organophosphate (OP) poisoning, including nerve agents, in adult and pediatric populations, and procurement of 2-PAM autoinjectors for the SNS/CHEMPACK Program.

SCOPE

Independently and not as an agent of the USG, the Offeror shall furnish all the necessary services, qualified personnel, materials, supplies, equipment, and facilities not otherwise provided by the USG as needed to perform the work described below.

The USG is seeking to procure and maintain approximately 2,000,000 autoinjectors for the treatment of organophosphate (OP) poisoning, including nerve agents. 2-PAM (600mg) autoinjectors shall be delivered to the SNS/CHEMPACK Program. 2-PAM autoinjectors in the legacy MARK1 kits and ATNAA/DuoDote® will be replaced by 2-PAM 600 mg single dose autoinjectors under this planned procurement. The USG will utilize this procurement of 2-PAM autoinjectors to prepare for a mass casualty event involving nerve agents. 2-PAM autoinjectors shall be FDA approved as a drug/device combination product for the treatment of OP poisoning, including nerve agents, or acceptable for use under an EUA.

The scope of the base period will include late-stage development activities necessary to support FDA approval of 2-PAM autoinjectors and the initial procurement of 2-PAM autoinjectors. Optional CLINs will include procurement of autoinjectors as well as additional late-stage development activities, fulfillment of additional USG security requirements as necessary and Post-Marketing Commitments.

Procurement options represent a series of incremental purchases of 2-PAM autoinjectors until the entire requirement for the manufacturing and procurement of approximately 2,000,000 2-PAM (600mg) autoinjectors are met.

The statement of objectives is outlined in the following sections that the Offeror(s) shall address in their proposed statement of work:

Section 1: Program Management and Risk Mitigation Objectives

Section 2: Late-Stage Product Development Objectives

Section 3: Supply and Delivery of Product Objectives

Section 4: Post-Marketing Commitments and/or Requirements (Option)

Section 5: Additional Procurements (Option)

SECTION ONE

1. PROGRAM MANAGEMENT AND RISK MITIGATION OBJECTIVES

The Offeror is directed towards details provided in Section F for items below.

1.1. The Offeror shall submit program/risk management documents as described in Section F

– Deliveries or Performance.

1.2. The Offeror shall develop and maintain a risk mitigation plan that is acceptable to the CO and COR. This shall include a risk matrix per Attachment 13. The Offeror shall provide a security plan which is associated with all aspects of manufacture of product, process, storage, and inventory of the 2-PAM autoinjectors. The Security Plan shall include all sites within the supply chain, including proposed shipping carriers. For those sites/carriers that are not defined at the time of award or are added during the period of performance, individualized Security Plans shall be provided to the USG prior to inclusion of sites/carriers into the supply chain. BARDA’s Program Protection Office will be authorized to review and approve Security Plans and will conduct annual audits / site visits to ensure a reliable product is delivered to the USG. Security requirements and a template for a Security Plan are included in Attachments 15 and 16, respectively.

1.3 The Offeror submitting a proposal will be required to provide a copy of their facility security plan with their proposal in response to this solicitation. The Offeror is responsible for ensuring all proposed subcontractors provide a facility security plan to be included in the submission.

SECTION TWO

2. LATE-STAGE PRODUCT DEVELOPMENT OBJECTIVES: BASE (CLIN 0001)

2.1.1. The Offeror shall demonstrate that they can manufacture 2-PAM (600 mg) autoinjectors that are considered approvable according to FDA guidance and regulation for the treatment of OP poisoning, including nerve agents, in adult and pediatric populations.

2.1.2. 2-PAM autoinjectors must demonstrate compliance with FDA reliability standards outlined in the Draft Guidance for Technical Considerations for Demonstrating Reliability of Emergency-Use Injectors Submitted under a BLA, NDA or ANDA. For more information, visit https://www.fda.gov/regulatory-information/search-fda-guidance-documents/technical-considerations-demonstrating-reliability-emergency-use-injectors-submitted-under-bla-nda.

2.1.3. The product shall have an OP poisoning indication for use in adults and pediatric populations (2+ years).

2.1.4. The product shall be FDA approved or have an authorized EUA with a minimum of three years stability at the intended storage temperature.

2.1.5. The product shall be manufactured at a scale capable of meeting the USG requirements for stockpiling.

2.2. REGULATORY OBJECTIVES

2.2.1. The Offeror shall maintain and update, as required by the FDA, all regulatory documentation (Design History File (DHF), clinical documentation, regulatory binder, etc.) that will be used to support use under EUA and/or FDA approval.

2.2.2. The Offeror shall obtain FDA concurrence on the appropriate path for regulatory evaluation and FDA approval of 2-PAM autoinjectors, as a drug/device combination product, for the treatment of OP poisoning, including nerve agents, in adult and pediatric populations.

2.2.3. The Offeror shall prepare all documentation for and conduct all necessary meetings with the FDA to support submission of a New Drug Application (NDA).

2.2.4. If investigational product is distributed under EUA authorization, upon FDA approval, the Offeror shall re-label such product to be consistent with the approved product, in accordance with regulatory requirements from the FDA.

2.2.5. The Offeror shall satisfy any Post Marketing Commitments (PMC) required for maintaining the approval including any studies to monitor safety and efficacy during a nerve agent emergency.

2.3. CLINICAL OBJECTIVES

2.3.1. The Offeror shall conduct all necessary clinical studies to support regulatory approval of 2-PAM autoinjectors for the treatment of OP poisoning, including nerve agents, in adult and pediatric populations.

2.3.2. The Offeror shall prepare and submit to BARDA a Final Study Report containing 100% quality-controlled data and the completion of the clinical study. This report should be prepared in accordance with FDA and ICH Guidelines.

2.4. CHEMISTRY, MANUFACTURING, CONTROL (CMC) OBJECTIVES

2.4.1. The Offeror shall deliver product with established acceptable product quality attributes meeting the proposed product safety and efficacy during product shelf life.

2.4.2. The Offeror shall provide a Manufacturing Plan that includes a facility regulatory compliance plan addressing cGMP standards; description of the manufacturing facility quality assurance and regulatory acceptance including quality systems, validation master plan and regulatory milestones.

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/technical-considerations-demonstrating-reliability-emergency-use-injectors-submitted-under-bla-nda https://www.fda.gov/regulatory-information/search-fda-guidance-documents/technical-considerations-demonstrating-reliability-emergency-use-injectors-submitted-under-bla-nda https://www.fda.gov/regulatory-information/search-fda-guidance-documents/technical-considerations-demonstrating-reliability-emergency-use-injectors-submitted-under-bla-nda

2.4.3. The Offeror shall complete any remaining manufacturing and quality control activities needed to support FDA approval.

2.4.4. The Offeror shall conduct long-term stability studies on 2-PAM autoinjectors to establish an expiry period of at least three years.

2.4.5. The Offeror shall demonstrate capability and compliance for all required CMC activities. These include but are not limited to those listed below:

a) Final product manufacturing according to cGMP standards, process & equipment validation of analytical methods and assays appropriate for product characterization and product release, including tests for the identity, purity, potency, and for demonstrating stability of 2-PAM autoinjectors to support FDA approval. Assure selected materials and vendors are cGMP compliant.

b) Identify a stable source and availability of reagents and reference standards for these assays as required; execute product stability testing plans as evidenced by available data towards the intended product stability.

c) Develop and maintain documentations such as those describing quality control (QC) and quality assurance (QA) monitoring plan, manufacturing process, facility information, product storage and monitoring inventory systems, process flow for personnel, material and waste disposal.

d) Package 2-PAM autoinjectors to provide for the most cost-effective product life-cycle value and performance, and to allow for ease of distribution and use during a declared emergency.

SECTION THREE

3. SUPPLY AND DELIVERY OF PRODUCT OBJECTIVES BASE (CLIN 002) and OPTIONS (CLINs 0004 and 0006) Delivered 2-PAM autoinjectors must be FDA approved or acceptable for use under EUA, in accordance with all federal, state and local regulations, as well as international regulations, if applicable. During the initial option period, the USG estimates procuring a maximum of 310,000 autoinjector devices, and if all options are exercised, the USG estimates procurement of a maximum of 1,700,000 autoinjectors. Offerors must propose price per autoinjector, including required labeling/packaging and delivery to SNS/CHEMPACKs. The source of transportation used by the Offeror for the delivery of product must meet USG security requirements. Product will be delivered to the SNS/CHEMPACK Program in a manner consistent with FDA guidance for EUA or FDA Approved Medical Products, under section 564 of the Federal Food, Drug, and Cosmetic Act, which was amended by the Project BioShield Act of 2004 and the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013. Further guidance can be found at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities .

3.2. The Offeror shall store 2-PAM autoinjectors at their own facility, in compliance with cGMP, until release testing has been completed. The final packaged 2-PAM autoinjectors will be shipped to and stored at the SNS/CHEMPACKs.

3.3. The Offeror shall maintain cGMP compliance and quality control of stored 2-PAM autoinjectors and stability assays to ensure expiry dating for the duration of the contract.

SECTION FOUR

4. POST-MARKETING COMMITMENTS AND/OR REQUIREMENTS (OPTIONs CLINs 0003 and 0005)

4.1. The Offeror shall commit to comply with Post-Marketing Commitments and/or

Requirements (PMCR) as specified by the FDA. Cost estimates may be based on tentative plans in place prior to direction from the FDA. Based on guidance from the FDA, select items from section 4 of the Statement of Objectives may be moved to the PMCR section.

SECTION FIVE

5. ADDITIONAL PROCUREMENT: No additional procurement is needed at this time.

C.2. REPORTING REQUIREMENTS

See Section F for specific reporting requirements.

Performance of the contract will be monitored by the Contracting Officer (CO)/Contracting Officer’s Representative (COR)on a regular basis. The Contracting Officer will be responsible for inspection and acceptance of deliverables and services. Monitoring of the contract will be based on periodic reporting by the Offeror.

C.3. MEETINGS/SITE VISITS

The Offeror and BARDA/CMA shall participate in regular meetings to coordinate and oversee the contracting effort as requested by the Contracting Officer (CO)/Contracting Officer’s Representative (COR). Such meetings may include, but are not limited to, a kickoff meeting to be held at a location determined by the Government, status update meetings and/or teleconferences, site visits to the Offeror’s and/or Offeror’s subcontractor facilities, and meetings with individual Offerors and other HHS officials to discuss the technical, regulatory, and contractual aspects of the program. The Offeror shall provide data, reports, and presentations to USG personnel and USG-contracted subject matter experts as required by the CO/COR facilitating review of activities.

The purpose of the kickoff meeting will be to orient the Offeror to HHS/BARDA and review contract requirements. This meeting usually occurs within a month after contract award. Bi-weekly or monthly status update meetings/teleconferences will be held. The schedule for these meetings will be established by the CO and COR.

Periodic site visits shall occur on an ad hoc basis (anticipate at least twice a year).

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

Other U.S. Government Audits The USG reserves the right to conduct an audit of the Offeror with 48 hours advance notice. The USG reserves the right to accompany the Offeror on routine and for-cause site-visits/audits of Offeror subcontractor(s). At the discretion of the USG and independent of testing conducted by the Offeror, BARDA reserves the right to conduct site visits/audits and collect samples of product held by the Offeror and Offeror’s subcontractor(s).

Pre-award site visits may be made with short notice. Offerors are expected to guarantee the availability of key staff or other staff determined by the Government as essential for purposes of this site visit.

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 adhere to guidelines found 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 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 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 Office of the Assistant Secretary for 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 52.246-2 Inspection of Supplies-Fixed-Price (Aug 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) (Apr 1984)

FAR 52.246-16, Responsibility for Supplies (Apr 1984)

SECTION F – DELIVERIES OR PERFORMANCE

F.1. PERIOD OF PERFORMANCE

The base period of performance of this contract is anticipated for thirty six (36) months from the date of award. The period of performance may be extended with the exercise of option(s), structured as CLINs, as 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 Contracting Officer (CO), Jonathan.Gonzalez@hhs.gov. No hard copies will be accepted.

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 sub-offeror performance and personnel changes). Offerors must 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, mailto:Jonathan.Gonzalez@hhs.gov 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 (3) 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 include in this section 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.

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 sub-offeror performance and personnel changes). Offerors must 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 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 (3) 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 include in this section 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.

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 are to include a summation of the work performed and results obtained for 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 forty-five (45) calendar days prior to the expiration date of the contract and the Final Progress Report is due no later than 30 days following 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.

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 (5) 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/or specific analysis of data generated with USG funds upon request from the COR.

g) The Offeror shall notify the Contracting Officer’s Representative and Contracting Officer 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 Contracting Officer’s Representative and Contracting Officer 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 plans execution, and a copy of all final responses to the FDA. The Offeror shall also provide redacted copies of any FDA audits received from sub-Offerors that occur as a result of this contract or for this product. The redactions shall be limited to issues that are unrelated to the sub-offeror’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

a) Performance Measurement Baseline Review (PMBR)

The Contractor shall submit a plan for a PMBR to occur within 90 days of contract award.

At the PMBR, the Contractor and BARDA shall mutually agree upon the budget, schedule and technical plan baselines (Performance Measurement Baseline). These baselines shall be the basis for monitoring and reporting progress throughout the life of the contract. The PMBR is conducted to achieve confidence that the baselines accurately capture the entire technical scope of work, are consistent with contract schedule requirements, are reasonably and logically planned, and have adequate resources assigned. The goals of the PMBR are as follows:

- Jointly assess areas such as the Contractor’s planning for complete coverage of the SOW, logical scheduling of the work activities, adequate resources, and identification of inherent risks

- Confirm the integrity of the Performance Measurement Baseline (PMB)

- Provide confidence in the validity of Contractor reporting

- Identify risks associated with the PMB

- Present any revised PMBs for mutual agreement

- Present an Integrated Master Project Plan

- Present the Risk Management Plan

b) Integrated Master Project Plan

The Offeror shall provide an Integrated Master Project Plan (including tabular and Gantt forms) to the COR that clearly 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 CDC) for 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 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 and/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 https://www.phe.gov/about/contracts/Documents/risk-management.pdf) 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.

c) Deviation Request During the course of contract performance, in response to a need to change IMS activities as baselined at the PMBR, the Contractor shall submit a Deviation Report. This report shall request a change in the agreed-upon IMS and timelines. This report shall include: (i) discussion of the justification/rationale for the proposed change; (ii) options for addressing the needed changes from the agreed upon timelines, including a cost-benefit analysis of each option; and (iii)recommendations for the preferred option that includes a full analysis and discussion of the effect of the change on the entire product development program, timelines, and budget.

1. Technology Packages

Technology packages developed under the contract that include complete protocols must be submitted at the request of the Contracting Officer’s Representative. 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.

2. Experimental Protocols https://www.phe.gov/about/contracts/Documents/risk-management.pdf

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.

3. 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 Contracting Officer.

4. Publications

Any…