8 RFP_PBS_AMR_2025_Final SAM.docx

SOLICITATION, OFFER AND AWARD

1. THIS CONTRACT IS A RATED ORDER RATING

UNDER DPAS (15 CFR 7900)

PAGE OF PAGES

75A50125R00005

4. TYPE OF SOLICITATION SEALED BID (IFB)

NEGOTIATED (RFP)

HHS / ASPR / DAAPPO / BARDA DCMA

CONSTITUTION CENTER OFFICE BLDG, WASHINGTON, DC 20024

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

Erin Greninger

erin.greninger@hhs.gov

AREA CODE

NUMBER

210-7767

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

Biomedical Advanced Research and Development Authority (BARDA) Request for Proposals (RFP) for Antibiotic for Treatment of Bacterial Pneumonia or Bloodstream Infections

RFP #: 75A50125R00005

Issued: July 12, 2025

Initial Questions Due: July 29, 2025

Supplemental Questions Due: August 08, 2025

Proposal Responses Due: August 25, 2025

Contracting Officer: Erin Greninger – Erin.Greninger@hhs.gov Contract Specialist: Audrey Glover – Audrey.Glover@hhs.gov

Antibiotic for Treatment of Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia or Bloodstream Infections Caused by Drug-Resistant Bacteria or Biothreat Pathogens

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 submittal of a proposal.

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.

Initial questions on this RFP are July 29, 2025, at Noon, EST and supplemental questions due August 8, 2025, at Noon, EST. All questions shall be submitted via e-mail to Erin.Greninger@hhs.gov and Audrey.Glover@hhs.gov.

PART I – THE SCHEDULE

SECTION B – SUPPLIES OR SERVICE AND PRICE / COST

B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The United States Government (USG) seeks an antibiotic that treats bloodstream infections (BSI) or hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by drug-resistant bacteria. The antibiotic could also be for the treatment and, if feasible, post-exposure prophylaxis (PEP) for one or more biothreat indications (Y. pestis, F. tularensis, or B. pseudomallei). Products that expand the USG’s existing preparedness posture for treating antimicrobial-resistant infections will be the highest priority. The product must be either U.S. Food and Drug Administration (FDA)-approved within the last 15 years, or the program completed an end-of-Phase 2 meeting with the FDA and have a Phase 3 development plan that has been favorably reviewed by the FDA for HABP/VABP and/or BSI. The product must be broad-spectrum, targeting two or more drug-resistant pathogen(s) identified as Urgent or Serious Threats in the CDC’s 2019 report: Antibiotic Resistance Threats in the United States. Generic antibiotics will not be considered under this solicitation.

Under this Request for Proposal (RFP), BARDA intends to use Project BioShield (PBS) funds to support the late-stage development, approval, and potential procurement of an antibiotic. It is anticipated that at least one award may be made from this RFP solicitation. The anticipated contract award(s) includes completion of the regulatory pathway for a BSI or HABP/VABP indication and/or biothreat indication(s) as well as any efforts related to post-marketing commitments/requirements (PMCR). If Offerors propose a biodefense indication, the biodefense development plan for treatment and, if feasible PEP, must have already been discussed with the FDA. This development plan must include the conduct of a Phase 3 clinical trial for a pneumonic indication if the product is not already approved for such an indication and such a study is recommended by the FDA to support the biothreat indication(s). An alternative development/regulatory path may be proposed if a pneumonic indication is not required by the FDA. FDA concurrence with this alternative approach must be provided with the proposal. During the course of the biothreat development program, the Offeror will provide necessary data to support an investigational or emergency use of the USG procured product in the event of a localized outbreak or emergency under an appropriate FDA regulatory mechanism. The timing of such submission by USG will depend on the available data. If milestones are met during development, BARDA may procure the antibiotic using PBS funds for delivery to the ASPR Strategic National Stockpile (SNS) or maintain the antibiotic as vendor-managed inventory (VMI).

B.2. PRICES / COSTS/ PERIOD OF PERFORMANCE

The final contract will contain the price/cost provisions agreed upon by the Government and the Offeror. It is anticipated the total contract period of performance (base plus option periods) will be up to 10 years. The base period includes a cost-plus-fixed-fee (CPFF) contract line-item number (CLIN) to support late-stage development for a BSI or HABP/VABP indication or a biothreat indication. Supplementary CPFF options will be dedicated to additional late-stage development; post-marketing commitments as established by the FDA; BARDA security requirements; on-shoring commercial manufacturing activities, as feasible; and shelf-life extension program activities, as necessary. Firm-fixed-price (FPP) options will include CLINs to support the procurement of treatment, or, if relevant, PEP courses of the antibiotic as final drug product (FDP) for delivery to the ASPR SNS, or as FDP that can be held in VMI until delivery to the ASPR SNS or another site as designated by the USG.

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

B.2.1. BASE PERIOD

Base Period CLIN

AND/OR, late-stage development to support Pre-EUA through FDA marketing authorization for biothreat indication(s) (non-clinical, clinical, regulatory).

9/30/25-9/30/30

B.2.2. OPTION PERIODS

1. The Government may exercise an Option Period in accordance with FAR 52.217-8 Option to Extend Services (Nov 99) 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 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:

(Option)

Total

Optional Fixed Price CLINs

0008B

0010A

0010B

0011A

0011B

* Per Section L.5.1., Offerors must propose 2,500 treatment courses with a realistic capacity to deliver product in addition to the corresponding price per treatment course. However, the USG has discretion to determine the amount of product to be procured based on availability of funds and priorities/requirements.

† When budgeting these costs assume the longest route for delivery within the continental United States.

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 (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.

1. Subcontracts

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

· Is of the cost-reimbursement, time and materials, or labor hour type or;

· Is of the fixed price type and exceeds $250,000.00 or 5% of the contract value

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, Contractor shall provide a copy of the signed executed subcontract and consulting agreement to the Contracting Officer within ten (10) calendar days following execution of such agreement.

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

2. Overtime Compensation

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

3. Rights in Data

The contract will incorporate the FAR Clause 52.227-14, Rights in Data-General, Alternate II (DEC 2007).

B.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.

The Government will not reimburse FDA regulatory filing fees.

B.5 ORGANIZATIONAL CONFLICT OF INTEREST(S)

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.

SECTION C – DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

1.1. STATEMENT OF OBJECTIVES

C.1.1 BACKGROUND AND PURPOSE

The prevalence of infections caused by antibiotic-resistant pathogens is a threat to the health security of the United States. Community- and hospital-acquired antibiotic-resistant infections can complicate the Department of Health and Human Services (HHS) response to emergencies, natural disasters, and chemical, biological, radiological, and nuclear (CBRN) events. The illness and injuries caused by CBRN threats can lead to secondary bacterial infections, many of which can be antibiotic-resistant. Antibiotic resistance also has the potential to render the current stockpile of antibiotic MCMs for biothreat pathogens ineffective. Development and procurement of antibiotics that overcome known forms of resistance and treat biothreat pathogens will enhance the USG’s emergency preparedness.

BARDA and the PHEMCE recognize the critical need to prepare for an outbreak of antibiotic-resistant secondary bacterial infections. This acquisition will address this gap by supporting the late-stage development, FDA marketing authorization, procurement, and stockpile of antibiotics for the treatment of drug-resistant secondary bacterial infections. The acquired products will directly address PHEMCE requirements established in the Materiel Requirements for Medical Countermeasures to Antimicrobial Resistant Infections Resulting from CBRNE Exposures, and the 2014 National Strategy and Action Plan to Combat Antibiotic Resistant Bacteria. Supporting the development and stockpiling of MCMs that have the potential to treat antibiotic-resistant bacterial infections is necessary for a USG response to health security threats.

C.1.2 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 an antibiotic for the treatment of BSI or HABP/VABP and, if feasible, the treatment and/or PEP of a biothreat indication (Y. pestis, F. tularensis, or B. pseudomallei). The USG has the discretion to determine the amount of product to be procured based on availability of funds and priorities/requirements. The USG may procure quantities of the antibiotic product when contract milestones are met. The antibiotic shall be delivered to the ASPR SNS, and/or maintained as VMI as determined by BARDA and the Contracting Officer. The treatment and/ PEP courses shall be provided as FDP.

The scope of the Base Period may include late-stage development activities necessary to support an FDA approval for BSI or HABP/VABP or FDA marketing authorization (nonclinical, clinical, and regulatory) for a biothreat indication. Option Period(s) will include additional late-stage development activities; BARDA security requirements, onshoring commercial manufacturing activities, and shelf-life extension program activities; post-marketing commitments/requirements; and purchases of antibiotic treatment and/or PEP courses.

The statement of objectives outlined in the following sections shall be addressed by the Offeror in their proposed statement of work:

Section 1: Program Management and Risk Mitigation Objectives Section 2: Late-stage Product Development Objectives Section 3: Post-Marketing Commitments/Requirements Section 4: Procurement Objectives Section 5: Storage and Delivery of Product Objectives

1. PROGRAM MANAGEMENT AND RISK MITIGATION OBJECTIVES

The Offeror is directed toward details provided in Section F for the 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 Contracting Officer’s Representative (COR). This shall include a risk matrix per Attachment 14.

1.3 The Offeror shall provide a Security Plan that is associated with all aspects of FDP supply chain, including the manufacture of product, storage, inventory, and shipping of the FDP. 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 16 and 17, respectively.

1.4 The Offeror submitting a proposal will be required to provide a copy of their facility’s 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.

1.5 The Offeror must provide a Target Product Profile, a commercial development strategy for the product, and a corporate sustainability strategy.

2. LATE-STAGE PRODUCT DEVELOPMENT OBJECTIVES (BASE CLIN and OPTION CLINs)

2.1. GENERAL PRODUCT DEVELOPMENT OBJECTIVES

2.1.1. Unless already FDA approved, the Offeror must propose a development plan to support a primary indication of BSI or HABP/VABP including nonclinical, clinical, and chemistry, manufacturing, and control (CMC) activities as necessary. The product must have demonstrated data that will support NDA/sNDA approval for a BSI or HABP/VABP indication, including the relevant microbiological profile, target attainment and therapeutic efficacy through PK/PD studies. The proposed development plan must have been discussed with the FDA.

2.1.2. If proposing a development plan for a biodefense indication, the product minimally must have demonstrated in vitro efficacy against one or more of the following biothreat pathogens: Y. pestis, F. tularensis, or B. pseudomallei. All data supporting activity and efficacy against the biothreat pathogen(s), as well as a development plan that has been discussed with the FDA must be presented in the proposal.

2.1.3. The Offeror must propose plans to achieve five years of stability for the FDP, process validation, registration batches, and annual commercial manufacturing programs.

2.2. REGULATORY OBJECTIVES

2.2.1. The Offeror shall maintain and update, as required by the FDA, all required regulatory documentation (investigator brochure, regulatory binder, etc.), that will be used to support an investigational or emergency use in the event of a localized outbreak or public health event and marketing authorization packages for review by the FDA.

2.2.2. The Offeror shall obtain FDA concurrence on the appropriate path for regulatory evaluation and marketing authorization (i.e., traditional, accelerated, or Animal Rule).

2.2.3. The Offeror shall conduct all necessary meetings with the FDA to support the submission of an NDA or evaluation through an amendment to an existing marketed product to the FDA.

2.2.4. During the course of a potential biothreat development program, the Offeror will provide necessary data to support an investigational or emergency use of the USG procured product in the event of a localized outbreak or public health emergency under an appropriate FDA regulatory mechanism. Offeror shall share the data package with the USG for submission of a pre-EUA package to the FDA. The timing of submitting this data package to regulators will depend on the available data and whether it will support the submission of a Pre-EUA (thus supporting an EUA request should an emergency be declared).

Note: The Offeror is strongly encouraged to review the FDA’s guidance to industry on EUAs and hold a Type B meeting with the FDA prior to proposal submission to discuss the proposed biothreat development and regulatory path.

2.2.5. As a potential EUA requestor, the Offeror and the USG shall seek FDA concurrence that the IND/sNDA labeling is acceptable for an EUA and could be used under EUA without the need to re-label the product. If the FDA does not find the existing IND/sNDA labeling adequate for safe and effective use of the product under the EUA, the Offeror shall re-label the product in accordance with regulatory requirements from the FDA.

2.2.6. The Offeror shall re-label the investigational product (upon marketing authorization) to be consistent with the licensed product, in accordance with regulatory requirements from the FDA.

2.3. NONCLINICAL OBJECTIVES

2.3.1. The Offeror shall perform the appropriate late-stage nonclinical safety studies needed to establish product safety, as needed.

2.3.2. The Offeror shall conduct any FDA required efficacy studies to support FDA marketing authorization.

2.3.3. The Offeror shall conduct any FDA required PK studies to support FDA marketing authorization of a BSI or HABP/VABP and/or biothreat indication, if required.

2.3.4. The Offeror shall conduct any PK/PD modeling to establish an appropriate clinical dose and regimen for a BSI or HABP/VABP and/or biothreat indication.

2.4. CLINICAL OBJECTIVES

2.4.1. The Offeror shall conduct any FDA required efficacy studies to support FDA marketing authorization of a BSI or HABP/VABP indication.

2.4.2. The Offeror shall complete any remaining clinical studies to support clinical safety under the Animal Rule as necessary for a potential biothreat indication as directed by BARDA and the FDA. The Animal Rule neither replaces the need nor establishes special requirements, for an adequate human safety database for drug development. The expectation is that drugs will be evaluated for safety under preexisting requirements for establishing the safety of new drugs and biological products. FDA anticipates that the nonclinical and clinical safety development programs will proceed in a manner similar to that of drugs developed under traditional regulatory pathways.

2.5. CHEMISTRY, MANUFACTURING, CONTROL OBJECTIVES

2.5.1. The Offeror shall provide plans for full process validation for registration/primary batches.

2.5.2. The Offeror shall develop and establish the manufacturing process for active pharmaceutical ingredients (API) and FDP.

2.5.3. The Offeror shall provide the status of the contract manufacturing organization (CMO), including location, and whether any US domestic capacity currently exists for both API/DS and fill/finish of DP. If U.S. domestic capacity does not yet exist, provide a timeline and summary of the approach to onshore both API/DS manufacturing and fill finish of DP. If U.S.-based manufacturing is not feasible, the Offeror must explain why and include an analysis of the cost to establish U.S.-based manufacturing of the starting materials, API/DS, and fill/finish of DP.

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

2.5.5. The Offeror shall provide a Manufacturing Plan that includes a facility regulatory compliance plan addressing current good manufacturing practice (cGMP) standard, a description of the manufacturing facility quality assurance (QA) and regulatory acceptance including quality systems, validation master plan, and regulatory milestones.

2.5.6. The Offeror shall complete any remaining manufacturing and quality control (QC) activities needed to support FDA marketing authorization, and the Offeror shall establish a regulatory strategy and filing processes for successful marketing authorization of the product.

2.5.7. The Offeror must propose plans to achieve five years of stability for the FDP, process validation, registration batches, and annual commercial manufacturing programs.

2.5.8. 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, process and equipment validation, analytical methods, and assays appropriate for product characterization and product release, including tests for the identity, purity, potency, and for demonstrating stability of the intermediate and FDP to support FDA marketing authorization.

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

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

d) Packaging of FDP 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.

e) Assures selected vendors are GMP compliant.

3. POST-MARKETING COMMITMENTS/REQUIREMENTS (PMCR)

3.1. The Offeror shall satisfy any PMCR required for maintaining FDA marketing authorization. Cost estimates for these studies may be based on tentative plans in place prior to direction from the FDA, if appropriate. The Offeror shall satisfy any PMCR required for maintaining the license, including any studies to monitor safety and efficacy during a biothreat emergency.

4. PROCUREMENT OBJECTIVES

4.1. It is anticipated that the USG may procure up to 10,000 patient courses per product. Procurements are anticipated to be made in increments based on the achievement of development milestones, USG requirements, and availability of funds. Specific milestones will be determined during contract negotiations. Examples are included in 4.2 and 4.3.

4.2. The USG may make an initial procurement when FDA approval (NDA or sNDA) is achieved for a BSI or HABP/VABP indication, based on the proposed development plan, and when the regulatory and quality requirements are met, as determined by BARDA.

4.3. For a biothreat indication, the USG may make an initial procurement prior to FDA approval when the following development and regulatory milestones (a-i) have been achieved for a biothreat indication:

a) In vitro microbiology data (MIC data for a panel of 50 biodefense isolates/strains)

b) Data on the activity or efficacy in animals that contribute to understanding the potential treatment and PEP effect in humans (e.g., proof-of-concept in vivo studies in one or more animal species)

c) Completed nonclinical toxicology and safety pharmacology studies that support the conduct of human clinical trials and marketing authorization for pharmaceuticals consistent with ICH M3(R2) taking into consideration the expected drug exposures and treatment duration related to the proposed use as a biothreat MCM.

d) Completed PK study in at least one sufficiently well-characterized animal model to be used for predicting the efficacy/response in humans for the biothreat indication.

e) Completed study demonstrating the exposure/response relationship as well as the fully effective dose in a well-characterized animal model expected to react with a response predictive for humans.

f) Selection of a human dose that is expected to be effective in humans based on the relationship between drug exposure and effectiveness established in animals and available human PK data.

g) Human safety information from clinical trials and individual patient experience at the expected drug exposures related to the proposed use as a biothreat MCM. The expectation is that the drug will be evaluated for safety under preexisting requirements for establishing safety of new drugs and the size and composition of the human safety database should be consistent with the proposed use of the drug.

h) Security, regulatory, and quality requirements (as determined by BARDA) must be met.

i) A Pre-EUA package for the product that includes the data from the development milestones has been filed for the biothreat indication(s) and all identified concerns have been adequately addressed.

4.4. The USG may procure additional quantities of antibiotics based on milestones achieved as relevant to the product’s proposed development plan. The milestones listed below are examples of when additional procurements may be initiated. Specific milestones to trigger procurement(s) will be determined during contract negotiations.

4.2.1. Completion of a predetermined set of post-marketing commitments. Offeror should propose appropriate PMCRs based on the product’s FDA requirements. Example PMCRs include 5-year post-marketing surveillance, an sNDA for pediatrics, or other sNDAs.

4.2.2. Transfer of manufacturing to domestic (USA based) manufacturing facilities for Active Pharmaceutical Ingredients (APIs)/Drug Substances (DS), Drug Products (DP), and fill/finish, if applicable. If an NDA includes approved offshore facilities (not USA based), completion of technology transfer to onshore manufacturing facilities, manufacturing of Process Performance Qualification (PPQ) batches, and applicable regulatory approval.

4.2.3. Successful achievement of five-year stability of drug product.

4.2.4. If a biothreat indication is being pursued, FDA approval of an sNDA for the biothreat indication.

5. STORAGE AND DELIVERY OF PRODUCT OBJECTIVES

5.1 The Offeror shall store FDP, in compliance with cGMP, until release testing has been completed. The FDP will be shipped to and stored at the ASPR SNS or maintained as VMI in a manner consistent with applicable FDA guidance and requirements. The source of transportation used by the Offeror for the delivery of the product will be subject to review as part of the overall Security Plan. Offeror must propose a price per treatment course for both VMI and ASPR SNS.

5.2 The Offeror shall maintain cGMP compliance and QC of stored FDP and stability assays to ensure expiry dating for the duration of the contract. As related to VMI, the contractor shall provide a general rotation plan and a rotation plan for the storage and delivery of the product, as applicable. In the plan, logistics for disposing of expired products should be provided. The plan shall also establish the timeframe for when BARDA is notified of expired products, to include batch numbers, and additional details as relevant, such as location of the batch, shipping destination, replacement of expired product in the inventory, etc. Proposed price rates should include the logistics noted.

5.3 The estimate for the total antibiotic procurement is 10,000 patient courses, composed of a combination of treatment and/or PEP, as applicable. However, the USG has the sole discretion to determine the amount of product to be procured based on the availability of funds and priorities/requirements. These efforts include manufacturing, stability testing, and storage. Offerors must propose a price per treatment course for both VMI and ASPR SNS.

5.4 The Offeror must implement a Vendor Managed Inventory (VMI) system and approach to store, manage, and deliver antibiotics manufactured under this project. The USG desires a VMI approach that utilizes a First-In-First-Out (FIFO) approach to inventory management while keeping the quantity of antibiotic (product manufactured under this Agreement to date minus product delivered to date) available for delivery to the USG as required (i.e. the USG will always have the most recently manufactured product available).

C.1.3. REPORTING REQUIREMENTS

See Section F for specific reporting requirements.

The performance of the contract will be monitored by the CO/COR on a regular basis. The CO will be responsible for the inspection and acceptance of deliverables and services. Monitoring of the contract will be based on periodic reporting by the Offeror.

C.1.4. MEETINGS/SITE VISITS

The Offeror and BARDA shall participate in regular meetings to coordinate and oversee the contracting effort as requested by the CO/COR. Such meetings may include, but are not limited to, a kickoff meeting to be held at a location determined by the COR, status update meetings or teleconferences, site visits to the Offeror’s and Offeror’s subcontractor facilities, and meetings with individual Offerors and other HHS officials to discuss the technical, regulatory, and ethical aspects of the program. The Offeror shall provide data, reports, and presentations to groups of outside experts and 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 the contract award. Expect biweekly or monthly status update meetings/teleconferences. The schedule for these meetings will be established by the CO and COR. Periodic site visits shall occur on an ad hoc basis (at least twice a year).

Within 30 calendar days of an FDA audit of the 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 good laboratory practice (GLP), good manufacturing practice (GMP), or good clinical practice (GCP) guidelines as identified in the final audit report.

Other U.S. Government Audits The 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 the purposes of this site visit.

SECTION D – PACKAGING, MARKING AND SHIPPING

D.1. METHOD OF DELIVERY

Unless otherwise specified by the Contracting Officer, all document 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 document 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

For delivery of product to the ASPR SNS, 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 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 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 delivery of the product(s) to the ASPR SNS, 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 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

At the discretion of the USG, BARDA reserves the right to conduct site visits/audits held by the Offeror and Offeror’s subcontractor(s). Inspection and acceptance of services and documentation called for herein shall be accomplished by the Contracting Officer or a duly authorized representative. Technical inspection and acceptance of documents will occur via email.

Product inspection and acceptance will take place at an Offeror-identified site for VMI or at a SNS site to be determined. The acceptance may be conducted in-person or virtually. Acceptance may be presumed unless otherwise indicated in writing by the Contracting Officer or the duty authorized representative within 30 days of receipt of the product.

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 52.246-3, Inspection of Supplies – Cost Reimbursement (May 2001)

FAR 52.246-5, Inspection of Services – Cost Reimbursement (April 1984)

FAR 52.246-7, Inspection of Research and Development – Fixed-Price (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) (April 1984)

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

SECTION F – DELIVERIES OR PERFORMANCE

F.1. ESTIMATED PERIOD OF PERFORMANCE

The estimated period of performance of this contract (base plus option periods) is anticipated to be up to 10 years from the date of award. Potential 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 an Annual Progress Report, 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 email 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.