Antimicrobial_RFP_FINAL.pdf

PAGES

15A. NAME

AND

ADDRESS

OF

OFFEROR

SEC. PAGE(S) SEC. PAGE(S)

(Date) (Hour)

CALENDAR DAYS

14. ACKNOWLEDGMENT OF AMENDMENTS

(The Offeror acknowledges receipt of amend-ments to the SOLICITATION for Offerors and related documents numbered and dated:

(Type or Print)

PAGES

(Date) (Hour)

SEC. PAGE(S) SEC. PAGE(S)

CALENDAR DAYS

14. ACKNOWLEDGMENT OF AMENDMENTS

(The Offeror acknowledges receipt of amend-ments to the SOLICITATION for Offerors and related documents numbered and dated:

15A. NAME

AND

ADDRESS

OF

OFFEROR

(Type or Print) mAUTHORIZED FOR LOCAL REPRODUCTION STANDARD FORM 33 (REV. 9-97) PREVIOUS EDITION IS UNUSABLE Prescribed by GSA

SOLICITATION, OFFER AND AWARD 1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

RATING

PAGE OF

1 103

2. CONTRACT NO.

N/A

3. SOLICITATION NO.

19-100-SOL-00011

4. TYPE OF SOLICITATION

SEALED BID (IFB)

X NEGOTIATED(RFP)

5. DATE ISSUED

05/08/2019

6. REQUISITION/PURCHASE

NO.

N/A

7. ISSUED BY CODE 8. ADDRESS OFFER TO (If other than Item 7)

HHS/OS/ASPR/AMCG

O’Neill House Office Building 200 C Street SW Washington, DC 20024

NOTE: In sealed bid solicitations “offer” and “Offeror” mean “bid” and “bidder.”

SOLICITATION

9. Sealed offers in original and 0 copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if handcarried, in the depository located in See Section L for Instructions until 4:00PM ET local time June 21, 2019

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

Christine Park

a. TELEPHONE (NO COLLECT CALLS)

202-401-5550

b. E-MAIL ADDRESS

Christine.Park@hhs.gov

11. TABLE OF CONTENTS

((x) DESCRIPTION (x) DESCRIPTION

PART I – THE SCHEDULE PART II – CONTRACT CLAUSES

X A SOLICITATION/CONTRACT FORM 01 X I CONTRACT CLAUSES 37

X B SUPPLIES OR SERVICES AND PRICES/COSTS 03 PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

X C DESCRIPTION/SPECS./WORK STATEMENT 06 X J LIST OF ATTACHMENTS 41

X D PACKAGING AND MARKING 12 PART IV – REPRESENTATIONS AND INSTRUCTIONS

X E INSPECTION AND ACCEPTANCE 13 REPRESENTATIONS, CERTIFICATIONS, AND

X F DELIVERIES OR PERFORMANCE 14 X OTHER STATEMENTS OF OFFERORS 42

X G CONTRACT ADMINISTRATION DATA 22 X L INSTRS., CONDS., AND NOTICES TO OFFERORS 51

X H SPECIAL CONTRACT REQUIREMENTS 25 X M EVALUATION FACTORS FOR AWARD 65

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 price 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)

10 CALENDAR DAYS

20 CALENDAR DAYS

30 CALENDAR DAYS

AMENDMENT NO. DATE AMENDMENT NO. DATE

CODE FACILITY 16. NAME AND ADDRESS OF PERSON AUTHORIZED TO SIGN OFFER

15B. TELEPHONE NO.

AREA CODE NUMBER EXT.

15C. CHECK IF REMITTANCE ADDRESS

IS DIFFERENT FROM ABOVE - ENTER

SUCH ADDRESS IN SCHEDULE.

17. SIGNATURE

18. OFFER DATE

AWARD (To be completed by Government)

19. ACCEPTED AS TO ITEMS NUMBERED 20. AMOUNT

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

21. ACCOUNTING AND APPROPRIATION

10 U.S.C. 2304(c)( ) 41 U.S.C. 253(c)( ) 23. SUBMIT INVOICES TO ADDRESS SHOWN IN (4 copies unless otherwise specified)

ITEM

24. ADMINISTERED BY (If other than Item 7) CODE 25. PAYMENT WILL BE MADE BY CODE

26. NAME OF CONTRACTING OFFICER (Type or print)

27. UNITED STATES OF AMERICA

(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.

FAR (48 CFR) 53.214©

K mailto:Brooke.Bernold@hhs.gov

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 L 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 May 21, 2019 until 12PM ET. All questions shall be submitted via e-mail to Christopher.Scott@hhs.gov and Christine.Park@hhs.gov.

mailto:Brooke.Bernold@hhs.gov mailto:Christopher.Scott@hhs.gov

PART I – THE SCHEDULE

SECTION B – SUPPLIES OR SERVICE AND PRICE / COST

B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

Antibiotic resistance complicates the treatment of community and hospital acquired bacterial infections as well as the response to public health emergencies and natural disasters. Due to the genetic promiscuity of bacteria, the same genetic markers that give rise to antibiotic resistance in hospital acquired infections can be transferred to biothreat pathogens (e.g. Y. pestis, B. anthracis, F. tularensis, B. mallei and/or B.

pseudomallei). These antibiotic-resistant biothreats, including those that are genetically engineered, are likely to be recalcitrant to the available treatment options in the Assistant Secretary for Preparedness and Response (ASPR) Strategic National Stockpile (SNS) during a major public health event. In order to address this gap, the current stockpile of antibiotic medical countermeasures (MCMs) must be augmented to include novel and next generation antibiotics. Procurement of antibiotic MCMs that treat biothreats and overcome known forms of resistance will achieve the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) preparedness goals as indicated in the 2017-2018 PHEMCE Strategy and Implementation Plan. Strategies to mitigate the threat of antibiotic resistance include the development and stockpiling of novel and next generation antibiotics for the general population. The Biomedical Advanced Research and Development Authority (BARDA) is seeking antibiotic(s) that can be safely and effectively used for the U.S. civilian population in individuals with antibiotic-resistant bacterial infections.

The United States Government (USG) desires an antibiotic(s) which can be used under Emergency Use Authorization (EUA) pre-approval or marketing authorization for the treatment of a biothreat indication (e.g.

Y. pestis, B. anthracis, F. tularensis, B. mallei and/or B. pseudomallei) while meeting the PHEMCE product requirements for MCMs to combat antibiotic-resistant bacterial infections. This notice seeks candidate antibiotics which have received marketing authorization from the U.S. Food and Drug Administration (FDA) for a pulmonary indication or are in Phase 3 clinical development for a pulmonary indication, and eligible for Emergency Use Authorization (EUA) pre-approval by FDA for a biothreat indication. If the antibiotic does not have FDA marketing authorization for a pulmonary indication, the Offeror must seek development and FDA marketing authorization for a pulmonary indication that could support EUA pre-approval or marketing authorization for a biothreat indication. Under this RFP, BARDA plans to support the procurement of antibiotic(s), which will either be delivered to the ASPR/SNS or maintained as VMI, using Project BioShield (PBS) funds. PBS funds will also support the necessary late-stage development to complete the regulatory pathway for a biothreat indication for the antibiotic(s) being procured (if applicable) and/or efforts related to post-marketing commitments.

B.2. PRICES / COSTS

The final contract will contain the price/cost provisions agreed upon by the Government and the Offeror. It is anticipated that the final contract will consist of a base period or performance up to five (5) years and a total contract period of performance (base plus option periods) up to 10 years with the exercise of options. The Base Period includes both a Cost Plus Fixed Fee (CPFF) Contract Line Item Number (CLIN) to support late-stage development with the goal of achieving EUA or FDA marketing authorization for a biothreat indication and a Firm Fixed Price (FFP) CLIN to support initial procurement related activities.

Supplementary CPFF and FFP options will be dedicated to additional late stage development; post-marketing commitments as established by the FDA; BARDA Security requirements as necessary; and procurement of additional treatment courses of the antibiotic(s) as Final Drug Product (FDP) for delivery to the ASPR/SNS, or as FDP which can be held in vendor managed inventory until delivery to the ASPR/SNS is required. Purchase of antibiotic treatment courses will occur once the antibiotic(s) is acceptable for use under an EUA or upon FDA marketing authorization for a biothreat indication. The options may be exercised within the base period of the contract, if needed. Below are the anticipated CLINs.

B.2.1. BASE PERIOD

Base Period Cost Reimbursement CLIN

CLIN Supplies/Services Estimated Cost Fixed Fee Cost + Fixed

Fee (CPFF)

0001 (Base)

Late stage development to support licensure of antibiotic(s) through EUA or FDA marketing authorization (nonclinical, clinical, regulatory)

Base Period Fixed Price CLIN

CLIN Supplies/Services Treatment Courses (# of Product)

Unit Price ($) Total ($)

0002 (Base)

Initial purchase, storage and delivery of antibiotic(s) as final drug product (FDP) to Vendor managed inventory (VMI) and/or

ASPR/SNS sites

1-2,5001

1 Per Section L.5.1., please propose up to 2,500 treatment courses with a realistic capacity to deliver product in addition to the corresponding price per treatment course.

B.2.2. OPTIONS

Optional Cost Reimbursement CLINs

CLIN Supplies/Services Estimated Cost Fixed Fee Cost + Fixed

Fee (CPFF)

0003 (Option)

Ongoing Late stage development to support licensure of antibiotic(s) through FDA marketing authorization (nonclinical, clinical, regulatory)

0004 (Option)

Supplemental Late stage development as requested by FDA to support licensure of antibiotic(s) through FDA marketing authorization (nonclinical, clinical, regulatory)

0005 (Option) BARDA Security Requirements

0006 (Option)

Post-Marketing Study Commitments/ Requirements for the authorized commercial indication including relabeling of approved drug in the ASPR/SNS or

VMI (this is an option that may or may not be exercised as required by the FDA)

0007 (Option)

Post-Marketing Study Commitments/ Requirements for the authorized biothreat indication including relabeling of approved drug in the ASPR/SNS or VMI (this is an option that may or may not be exercised as required by the FDA)

Optional Fixed Price CLINs

CLIN Supplies/Services Treatment Courses (# of Product)

Unit Price

Total

0008 (Option) Additional procurement of antibiotic(s) as final drug product (FDP) to Vendor managed inventory (VMI) and/or ASPR/SNS sites.

1-2,5002

0009 (Option) Additional procurement of antibiotic(s) as final drug product (FDP) to Vendor managed inventory (VMI) and/or ASPR/SNS sites.

1,25002

00010 (Option)

Additional procurement of antibiotic(s) as final drug product (FDP) to Vendor managed inventory (VMI) and/or ASPR/SNS sites.

1-2,5002

2 Per Section L.5.1., please propose from 1 – 2,500 treatment courses with a realistic capacity to deliver product in addition to the corresponding price per treatment course.

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.

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 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 $150,000.00;

j) Refreshments and Meal Expenditures;

k) Promotional Items

l) Printing

SECTION C – DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

C.1. STATEMENT OF OBJECTIVES

1. BACKGROUND AND PURPOSE

This Request for Proposal (RFP) covers the purchase and delivery of up to two different antibiotics that can be used to treat a biothreat infection under EUA or have received FDA marketing authorization for a biothreat indication. The USG is seeking to procure up to 10,000 treatment courses of the antibiotic(s) to treat a bio threat infection. When the antibiotic(s) are acceptable for use under an EUA as authorized by the FDA or upon FDA marketing authorization for a biothreat indication, the USG will procure sufficient product to meet some or its entire requirement.

Acceptance of the antibiotic(s) into the ASPR/SNS requires that the finished drug product meet, at a minimum, specifications determined by the FDA. The antibiotic(s) must be developed for potential use during a declared emergency under EUA pre-approval or FDA marketing authorization for the treatment of a bio threat.

A crisis has arisen from the simultaneous decrease in the number of pharmaceutical companies developing antibiotics and the dramatic increase in the prevalence of infections and deaths caused by antibiotic resistant pathogens. Additionally, the threat of naturally-occurring or intentionally-engineered antibiotic-resistant biothreat pathogens potentially impacts the effectiveness of the current stockpile of antibiotic medical countermeasures (MCMs) to treat these threats.

The year-over-year increase in hospital and community acquired bacterial infections due to antibiotic-resistant bacteria and the transmissibility of these resistant markers to sensitive bacteria represents a serious threat to the national health security of the United States. These health challenges also place a substantial health and economic burden on our society and will continue to do so if not adequately addressed.

The illnesses and injuries caused by all national security threats can lead to secondary bacterial infections, and those secondary bacterial infections can be antibiotic-resistant pathogens. A key objective of the 2018 National Biodefense Strategy is to reduce the emergence and spread of antibiotic-resistant pathogens domestically and internationally by accelerating research and development of new antibiotics. BARDA and the PHEMCE recognize the critical need to prepare for an outbreak of natural or engineered drug resistant bacterial biothreat pathogens. Supporting the development and stockpiling of medical countermeasures that treat antibiotic resistant bacteria including biothreats will augment the USG response to any biothreat agent or public health emergency.

This acquisition will allow BARDA to invest in the late stage development, marketing authorization, procurement, and stockpile of antibiotic products which are developed and received FDA marketing authorization for commercial use but also have utility in treating biothreat pathogens. The acquired products will directly address PHEMCE requirements established in the Product-Specific Requirement (PSR) for Medical Countermeasures to combat antibiotic-resistant bacterial infections, The National Strategy and Action Plan to Combat Antibiotic Resistant Bacteria, and the National Biodefense Strategy.

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 up to 10,000 treatment courses of an antibiotic(s) to treat a bio threat infection. The lack of diverse antibiotic MCMs and the increased prevalence of antibiotic resistant infections threatens to complicate the Department of Health and Human Services’ (HHS) response to any public health emergency or natural disaster, and represents a significant threat to the national health security of the United States. Antibiotic-resistant biothreat pathogens pose an equivalent risk to health security due to the limited treatment options for resistant infections and high mortality rates. The USG will utilize this anticipated procurement to prepare for an outbreak of natural or engineered drug resistant bacterial biothreat pathogens. The antibiotic(s) shall be delivered to the ASPR/SNS, and/or maintained as VMI as determined by BARDA and the Contracting Officer. The treatment course shall be provided as Final Drug Product (FDP). The USG will procure an antibiotic(s) upon EUA or upon FDA marketing authorization for use in the treatment of a biothreat indication.

The scope of the base period will include late-stage development activities necessary to support EUA and/or FDA marketing authorization, and procurement related activities. Options will include additional late-stage development activities, USG security requirements, Post-Marketing Commitments and incremental purchases of antibiotic treatment courses as needed.

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

Section 3: Program Management and Risk Mitigation Objectives Section 4: Late Stage Product Development Objectives Section 5: Procurement, Storage, or Delivery of Product Objectives Section 6: Post-Marketing Commitments and/or Requirements (Option) Section 7: Additional Procurements (Option)

3. PROGRAM MANAGEMENT AND RISK MITIGATION OBJECTIVES

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

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

Deliveries or Performance.

3.2. 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 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 15 and 16, respectively.

3.2.1. 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 gall proposed subcontractors provide a facility security plan to be included in the submission.

4. LATE STAGE PRODUCT DEVELOPMENT OBJECTIVES (BASE CLIN 0001 and OPTION

CLINS: 0003, 0004 and 0005)

4.1. GENERAL PRODUCT DEVELOPMENT OBJECTIVES

4.1.1. The Offeror shall demonstrate that their antibiotic has FDA marketing authorization for a pulmonary indication or in Phase 3 clinical development for a pulmonary indication, and eligible for EUA pre-approval by FDA for a biothreat indication (Y. pestis, B.

anthracis, F. tularensis, B. mallei and/or B. pseudomallei).

4.1.2. If the antibiotic does not have FDA marketing authorization for a pulmonary indication, the Offeror must seek development and FDA marketing authorization for a pulmonary indication that could support EUA pre-approval or FDA marketing authorization for treatment of a biothreat indication.

4.1.3. The oral and/or parenteral antibiotic(s) must have demonstrated efficacy against drug resistant bacteria to include demonstrated in vitro efficacy against one or more of the aforementioned biothreat pathogens.

4.1.4. The product shall have an indication for use in adults (Ages 18-55).

4.1.5. The product shall have a minimum of five years stability at the intended storage temperature.

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

4.2. REGULATORY OBJECTIVES

4.2.1. 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 use under EUA and/or marketing authorization.

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

4.2.3. The Offeror shall conduct all necessary meetings with the FDA to support submission of a New Drug Application (NDA) or evaluation through amendment to an existing marketed product to the FDA.

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

4.2.5. The Offeror shall satisfy any Post Marketing Commitments (PMC) required for maintaining the license including any studies to monitor safety and efficacy during a biothreat emergency

4.3. NON-CLINICAL OBJECTIVES

4.3.1. The Offeror(s) shall perform the appropriate late-stage toxicology studies to demonstrate product safety as a therapeutic against infection by a biothreat agent.

4.3.2. Additionally, non-clinical studies to demonstrate efficacy may be required to generate data to support FDA marketing authorization of the product for the treatment of a biothreat agent.

4.3.3. The Offeror shall conduct any FDA required efficacy studies to support FDA marketing authorization of a biothreat indication and a commercial indication, if required.

4.3.4. The Offeror shall conduct any FDA required PK studies to support FDA marketing authorization of a biothreat indication and a commercial indication, if required.

4.3.5. The Offeror shall conduct any PK/PD modeling and biothreat clinical dose determination.

4.4. CLINICAL OBJECTIVES

4.4.1. The Offeror shall complete any remaining Phase III pulmonary clinical studies to support clinical safety under the Animal Rule and biothreat indication as directed by

BARDA/FDA.

4.5. CHEMISTRY, MANUFACTURING, CONTROL (CMC) OBJECTIVES

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

4.5.2. 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.

4.5.3. The Offeror shall complete any remaining manufacturing and quality control activities needed to support FDA marketing authorization. And/or, the Offeror shall establish a regulatory strategy and filing processes for successful marketing authorization of the product.

4.5.4. The Offeror shall conduct long term stability studies on Bulk Drug Substance and FDP to establish an expiry period of at least five years.

4.5.5. 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, process & 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 documentations such as those describing quality control (QC) and quality assurance (QA) monitoring plan, and manufacturing process, facility information, product storage and monitoring inventory systems, process flow for personnel, 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

5. PROCUREMENT AND DELIVERY OF PRODUCT OBJECTIVES (BASE CLIN 0002)

5.1. The Offeror(s) shall provide an initial shipment of product manufactured using a validated process in accordance with cGMP, up to 2,500 treatment courses of antibiotic(s) when acceptable for use under EUA, in accordance with all federal, state and local regulations, as well as international regulations if applicable. The source of transportation used by the Offeror for the delivery of product must meet USG security requirements. Product will be maintained as VMI or delivered to the ASPR/SNS in a manner consistent with FDA guidance for EUA or market authorized 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 http://www.fda.gov/EmergencyPreparedness/Counterterrorism/ucm182568.htm.

5.2. 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 vendor managed inventory (Please propose price per treatment course for both VMI and

ASPR/SNS).

5.3. The Offeror shall maintain cGMP compliance and quality control of stored FDP and stability assays to ensure expiry dating for the duration of the contract.

6. POST-MARKETING COMMITMENTS AND/OR REQUIREMENTS (OPTION CLINs 0006 – 0007)

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

Requirements (PMCR) for the commercial indication 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.

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

Requirements (PMCR) for the biothreat indication 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.

7. ADDITIONAL PROCUREMENT (OPTION CLINs 0008 – 00010)

7.1. The estimate for the total antibiotic procurement is up to 10,000 treatment courses.

However, the USG has the sole discretion to determine the amount of product to be procured based on availability of funds. These efforts include manufacturing, stability testing, and storage. Please propose price per treatment course for both VMI and

ASPR/SNS.

7.2. To maintain preparedness, the USG shall at its discretion execute optional procurements

(See Section 5 for applicable requirements). These option CLINs (0008, 0009, 0010) shall support procurements of antibiotic. The procurement will consist of FDP shipped to the ASPR/SNS and or VMI.

C.2. REPORTING REQUIREMENTS

See Section F for specific reporting requirements.

Performance of the contract will be monitored by the CO/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/DCMA 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 COR, 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 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.

http://www.fda.gov/EmergencyPreparedness/Counterterrorism/ucm182568.htm

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. Expect Bi-weekly 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 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 be made by first class mail, overnight carrier, or email as described in SECTION F.3.

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and 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 be 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 (August 1996)

FAR 52.246-4, Inspection of Services - Fixed Price (August 1996)

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

FAR 52.246-8, Inspection of Research and Development – Cost-reimbursement (May 2001)

FAR 52.246-9, Inspection of Research and Development (Short Form) (April 1984)

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

SECTION F – DELIVERIES OR PERFORMANCE

F.1. PERIOD OF PERFORMANCE

The base period of performance of this contract is anticipated for sixty (60) months from the date of award.

The period of performance may be extended up to sixty (60) months 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) and the Contracting Officer’s Representative (COR). When electronic deliverables are not preferable by the Contracting Officer, all deliverables and reports furnished to the Government under any potential resultant contract (including invoices) shall be addressed as follows:

UPS/FedEx/Courier USPS Mail Packages Contracting Officer

HHS/ASPR/CMA

200 C St. SW Washington, DC 20024

Contracting Officer

HHS/ASPR/CMA

200 C St. SW

UPS/FedEx/Courier USPS Mail Packages Contracting Officer Representative

HHS/ASPR/BARDA

200 C St. SW Washington, DC 20024

Contracting Officer Representative

HHS/ASPR/BARDA

200 C St. SW

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 subOfferor performance and personnel changes). Please 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 (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.

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 subOfferor performance and personnel changes). Please 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.

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 subOfferor’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) 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 http://www.phe.gov/about/amcg/contracts/Pages/toolkit.aspx) to be completed by any prospective Offeror. This report shall be due within 90 days of contract award. Updates shall be due as requested by the COR.

1. Technology Packages

Technology packages developed under the contract that includes 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

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

5. Press Releases

The Offeror agrees to accurately and factually represent the work conducted under this contract in all press releases. The Offeror shall ensure the Contracting Officer has received and approved an advanced copy of any press release not less than five (5) business days prior to the issuance of any…