Ebola_Therapeutics_RFP.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)

AUTHORIZED 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

1 114

2. CONTRACT NO.

N/A

3. SOLICITATION NO.

17-100-SOL-00014

4. TYPE OF SOLICITATION

SEALED BID (IFB)

X NEGOTIATED(RFP)

5. DATE ISSUED

6. REQUISITION/PURCHASE

NO.

N/A

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

HHS/OS/ASPR/AMCG

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 12:00 PM local time June 23, 2017

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

Jason Bell

a. TELEPHONE (NO COLLECT CALLS)

202-260-1457

b. E-MAIL ADDRESS

Jason.Bell@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 39

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 43

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 44

X G CONTRACT ADMINISTRATION DATA 24 X L INSTRS., CONDS., AND NOTICES TO OFFERORS 53

X H SPECIAL CONTRACT REQUIREMENTS 27 X M EVALUATION FACTORS FOR AWARD 66

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 (120 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

NOTE TO OFFERORS

The information in SECTION A - Solicitation/Contract Form, contains important information for any Contractor 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 Contractors 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 Contractor's proposal may be included in the resultant contract.

The contract schedule is intended to provide the Contractor 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 18, 2017 until 12PM EST. All questions shall be submitted via e-mail to Jason.Bell@hhs.gov. The backup CO for this RFP is Christopher Scott; he can be reached at Christopher.Scott@hhs.gov. Please do not contact or copy Christopher Scott unless it is an urgent or important matter and Jason Bell is unavailable.

mailto:Jason.Bell@hhs.gov

PART I – THE SCHEDULE

SECTION B – SUPPLIES OR SERVICE AND PRICE / COST

Ebola Therapeutic

B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The 2016 Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy and Implementation Plan identifies Ebola as a High-Priority Threat. This designation is reserved for those threats that the Secretary of Homeland Security determines to pose a material threat sufficient to affect national security and/or that PHEMCE leadership determines to have the potential to seriously threaten national health security.

Medical countermeasures (MCM) that can be deployed in the event of an Ebola outbreak are a crucial component to the United States Government’s response plan and BARDA is seeking to augment the USG’s response capabilities with one or more MCMs that have, or are expected to receive, a therapeutic indication for Zaire Ebolavirus (ZEBOV). Project BioShield (PBS) funding for award(s) made under this RFP will support all efforts required for Emergency Use Authorization (EUA) and Licensure of the selected candidate(s) and procurement of Bulk Drug Substance (BDS) and/or Final Drug Product (FDP) to be held as Vendor-managed Inventory (VMI) or delivered to the Strategic National Stockpile (SNS).

B.2. PRICES / COSTS

The final contract will contain the price/cost provisions agreed upon by the USG and the Contractor. The contract will consist of a base period of up to five (5) years and up to 10 years with the exercise of options. There will be a total of up to 21 optional CLINs.

CLIN-0001 (Base Period) will support all efforts required to meet the objective of advancing an Ebola therapeutic to EUA and ultimately FDA licensure.

CLIN-0002 through CLIN-0006 (Base Period) will support an initial procurement of the therapeutic to be held as VMI or delivered to the SNS.

CLIN-0007 (Option Period) will support completion of Post-marketing Commitements required to maintain product licensure.

CLIN-0008 through CLIN-0027 will support Additional Procurement Phases. Each of the four phases are intended to augment product inventory procured under the Initial Procurement (CLIN-0002 through CLIN- 0006) and/or replace expired product.

Activities required to achieve and maintain Licensure (CLIN-0001 and CLIN-0007) will be supported under a Cost Plus Fixed Fee (CPFF) agreement. All procurement of product will be supported under a Firm Fixed Price (FFP) agreement. Proposals should adhere to the CLIN structure summarized in Section B.2.2. The final contract will include a CLIN structure agreed upon by the Government and the Contractor during the pre-award process.

B.2.1. PERIOD OF PERFORMANCE: The base period will be from ________ to ________.

B.2.2. ESTIMATED COST AND FIXED FEE

Base Period Cost Reimbursement CLINs

CLIN Description Estimated

Cost Fixed Fee Cost + Fixed

Fee (CPFF)

0001 Late Stage Development & Approval/Licensure TBD TBD TBD

Option Period Cost Reimbursement CLINs

Estimated

Cost Fixed Fee

Cost + Fixed Fee (CPFF)

Phase IV post marketing commitments (This is an option that may or may not be exercised as established by the FDA)

TBD TBD TBD

B.2.3. F IRM FIXED PRICE

Base Period Firm Fixed Price CLINs

Units Unit

Price Total

GMP Production and Release of Bulk Drug Substance (BDS) or Active Pharmaceutical Ingredient (API)

Up to 153,000 treatment course (TC) equivalents

TBD TBD

Storage of BDS or API as Vendor-managed Inventory (VMI)

Annual storage per TC equivalent

TBD TBD

0004 Fill/Finish Each FDP TC TBD TBD

0005 Storage of Final Drug Product (FDP) as VMI Annual Storage per TC TBD TBD

Delivery of FDP to the Strategic National Stockpile (SNS)

Delivery cost per TC TBD TBD

Option Period Firm Fixed Price CLINs

Units Unit

Price Total st

Additional Procurement Phase

GMP Production and Release of Bulk Drug Substance (BDS) or Active Pharmaceutical Ingredient (API)

Up to 150,000 treatment course (TC) equivalents

TBD TBD

Storage of BDS or API as Vendor-managed Inventory (VMI)

Annual storage per TC equivalent

TBD TBD

0010 Fill/Finish Each FDP TC TBD TBD

0011 Storage of Final Drug Product (FDP) as VMI Annual Storage per TC TBD TBD

Delivery of FDP to the Strategic National Stockpile

(SNS)

Delivery cost per TC TBD TBD nd

Additional Procurement Phase

GMP Production and Release of Bulk Drug Substance (BDS) or Active Pharmaceutical Ingredient (API)

Up to 150,000 treatment course (TC) equivalents

TBD TBD

Storage of BDS or API as Vendor-managed Inventory (VMI)

Annual storage per TC equivalent

TBD TBD

0015 Fill/Finish Each FDP TC TBD TBD

0016 Storage of Final Drug Product (FDP) as VMI Annual Storage per TC TBD TBD

Delivery of FDP to the Strategic National Stockpile

(SNS)

Delivery cost per TC TBD TBD rd

Additional Procurement Phase

GMP Production and Release of Bulk Drug Substance (BDS) or Active Pharmaceutical Ingredient (API)

Up to 150,000 treatment course (TC) equivalents

TBD TBD

Storage of BDS or API as Vendor-managed Inventory (VMI)

Annual storage per TC equivalent

TBD TBD

0020 Fill/Finish Each FDP TC TBD TBD

0021 Storage of Final Drug Product (FDP) as VMI Annual Storage per TC TBD TBD

Delivery of FDP to the Strategic National Stockpile

(SNS)

Delivery cost per TC TBD TBD th

Additional Procurement Phase

GMP Production and Release of Bulk Drug Substance (BDS) or Active Pharmaceutical Ingredient (API)

Up to 150,000 treatment course (TC) equivalents

TBD TBD

Storage of BDS or API as Vendor-managed Inventory (VMI)

Annual storage per TC equivalent

TBD TBD

0025 Fill/Finish Each FDP TC TBD TBD

0026 Storage of Final Drug Product (FDP) as VMI Annual Storage per TC TBD TBD

Delivery of FDP to the Strategic National Stockpile

(SNS)

Delivery cost per TC TBD TBD

B.3. ADVANCE UNDERSTANDINGS

The final contract may contain advance understandings between the Government and the Contractor.

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/WORKSTATEMENT

C.1. STATEMENT OF OBJECTIVES

1. Background and Purpose

This Request for Proposals (RFP) covers the purchase and delivery of at least one therapeutic against Viral Hemorrhagic Fever (VHF) caused by Ebola virus. The objective of this RFP will be to procure up to 753,000 treatment courses of a therapeutic(s) against Ebola, specifically, Zaire strains of Ebola virus (EBOV).

Ebola virus is a single-stranded, negative sense RNA virus of the Filoviridae family. There are five distinct species within the Ebolavirus genus; Zaire ebolavirus (ZEBOV), Sudan ebolavirus (SUDV), Bundibugyo ebolavirus (BDBV), Tai Forest ebolavirus (TAFV), and Reston ebolavirus (RESTV).

Filovirus genomes consist of seven genes encoding a nucleoprotein (NP), RNA-dependent RNA polymerase (L), matrix protein (VP40), polymerase cofactor (VP35), transcriptional activator (VP30), secondary matrix protein (VP24), and the glycoprotein (GP). Infections by Ebola virus result in a highly lethal viral hemorrhagic fever (VHF); mortality has ranged from 25-90 percent depending on the outbreak and the virus species by which it was caused. The disease generally starts with flu-like symptoms but can progress rapidly causing severe diarrhea, dehydration, and disorientation. Severe cases also involve extensive bleeding due to coagulation abnormalities and multi-organ dysfunction. VHF caused by Ebola virus can also be accompanied by a range of long-term issues in those patients that do survive. Joint pain, musculoskeletal pain, headaches, and ocular issues are often noted in surviving patients in the weeks following negative PCR tests.

In 2006, the Department of Homeland Security (DHS) determined that Ebola is a material threat to national health security. The threat of filovirus agents being used as biological/bioterror weapons led the DHS to issue a Material Threat Determination (MTD) based on its Material Threat Assessment (MTA) for Ebola Virus and Marburg Virus.

The 2014-2015 Ebola epidemic in West Africa highlighted the impact that Ebola can have on public health, with greater than 28,000 confirmed cases and more than 11,300 deaths. MCMs are a critical component of the USG’s response to public health emergencies and, as such, MCMs specific for deployment within an Ebola outbreak are urgently needed. In the event of a declared emergency prior to licensure of an MCM by the Food and Drug Administration (FDA)/Center for Biologics Evaluation and Review (CBER), it is anticipated that the investigational product may be administered under an Emergency Use Authorization (EUA) held by the USG.

Multiple awards may be made under this Request for Proposals (RFP). Each award will support efforts to reach FDA Licensure for a single product with a therapeutic indication for treatment of patients with Ebola Virus Disease (EVD). Each award will also support the procurement of that product to be held as Bulk Drug Substance (BDS) and/or Final Drug Product (FDP).

2. Scope:

Independently and not as an agent of the USG, the Contractor 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 at least one MCM with an indication for therapeutic use in individuals with EVD caused by ZEBOV. In order to meet this scope, the Statement of Objectives is outlined in the following eight sections that the Offeror(s) shall address in their proposal:

Section 3: Program Management and Risk Mitigation Objectives

Section 4: Emergency Use Authorization and FDA Licensure Objectives

Section 5: Initial Procurement Objectives

Section 6: [Contract Option] Post-Marketing Commitments and/or Requirements

Section 7: [Phase 1 Contract Options] Additional Procurements

Section 8: [Phase 2 Contract Options] Additional Procurements

Section 9: [Phase 3 Contract Options] Additional Procurements

Section 10: [Phase 4 Contract Options] Additional Procurements

Proposals will be evaluated in their ability to meet these objectives as described below.

3. Program Management and Risk Mitigation Objectives The Offeror is directed towards additional details provided in Section F for items below.

3.1. Program Management

3.1.1. The Offeror shall provide a Program Management and Risk Mitigation Plan that allows timely completion of all Deliverables listed in Section F.3.3.

3.1.2. The Offeror shall provide a list of individuals to serve as primary and secondary points of contact who will be notified in case of a public health emergency.

3.1.3. The Offeror shall provide a Security Plan which is associated with all aspects of manufacture of product, process, storage and inventory. 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. For additional information on BARDA security requirements for procurement contracts, see Section J, Attachments 15 and 16.

4. Emergency Use Authorization and FDA Licensure Objectives

Independently, and not as an agent of the USG, the Offeror shall furnish all the necessary services, qualified personnel, materials, supplies, equipment, facilities, transportation and travel not otherwise provided by the USG as required to fulfill the programmatic objectives.

4.1. General Product Development Objectives

4.1.1. The candidate therapeutic will need to demonstrate appropriate efficacy, as determined by the FDA, to allow continued progress towards a Biologics License Application (BLA) or New Drug Application (NDA).

4.1.2. The product shall seek indication for use in adults (18-65) and the Offeror may seek indication(s) for use in special populations (e.g. pediatrics, immunocompromised, elderly).

4.1.3. The product shall have a minimum stability of three years or, for products with fewer than three years of stability data available, confirmation of an ongoing stability program with data showing no significant loss of potency or product integrity.

4.1.4. Additional concept of operations factors (lyophilized powder formulation, elevated storage/shipping temperature, route of administration, therapeutic window, etc.) may be included in the development objectives.

4.1.5. The Offeror shall provide a draft Target Product Profile (TPP) which will be further developed through discussion and negotiation with BARDA and/or FDA. Guidance is available at FDA TPP Guidance to Industry:

http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidance s/ucm080593.pdf

4.2. Regulatory Objectives

4.2.1. The Offeror shall submit a Quality Management System (QMS) plan and a plan for meeting all regulatory and reporting requirements outlined in Section F.3.2.

4.2.2. The Offeror shall provide a clear and comprehensive regulatory master plan for obtaining product licensure. The plan must include risk evaluation and address outstanding items identified by FDA (toxicology, non-clinical and clinical studies, and manufacturing activities). The appropriate milestones for regulatory activities must be included the overall Gantt chart.

4.3. Non-Clinical Objectives

The Offeror(s) will have demonstrated that the product has a favorable toxicology profile in key toxicology studies and is effective as a therapeutic against infection by EBOV. Non-clinical study data should support FDA approval/licensure of the product with a therapeutic indication for use in patients with EVD.

4.3.1. The Offeror shall define the animal models in which toxicity and efficacy are assessed and seek concurrence from the FDA.

4.3.2. The Offeror shall conduct any required efficacy studies to support FDA approval/licensure.

4.3.3. The Offeror shall conduct any required toxicity studies to support FDA approval/licensure.

4.3.4. If Animal Rule is the pathway to licensure, the Offeror shall conduct pivotal animal GLP efficacy studies using final drug product formulation and use appropriate statistics to meet the requirements of the BLA/NDA submission. The current guidance should be utilized as amended.

http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidance s/ucm399217.pdf

4.4. Clinical Objectives

The Offeror will have demonstrated that the product is safe in human clinical trials at the efficacious dose to support product development. Human safety studies should be adequate to support FDA licensure of the product against EBOV.

4.4.1. The Offeror shall conduct all clinical studies in compliance with applicable local, state and federal rules and regulations as well as FDA guidance.

4.4.2. The Offeror shall complete any remaining clinical studies (e.g. Expanded Safety, Bridging, etc.) and evaluate critical biological outcomes using validated assays.

4.4.3. The Offeror shall demonstrate correlation between clinical and non-clinical studies if warranted by the regulatory path.

http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm080593.pdf http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm080593.pdf http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm399217.pdf http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm399217.pdf

4.5. Chemistry, Manufacturing, Control (CMC) Objectives

4.5.1. 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.

4.5.2. The Offeror shall complete GMP validation for manufacturing and quality control, and produce consistency lots or registration lots at a scale compatible with requirements for licensure.

4.5.3. The Offeror shall conduct long term stability studies on BDS and FDP to extend expiry dating with a goal of at least five years.

4.5.4. The Offeror shall maintain manufacturing capability in a validated state as appropriate.

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.

4.5.5.1. 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 as appropriate.

4.5.5.2. 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.

4.5.5.3. 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.

4.5.5.4. 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.

5. Initial Procurement Objectives

The Offeror shall provide initial shipment of product, up to 153,000 treatment courses of a therapeutic against EBOV, 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 either be maintained as vendor-managed inventory or be delivered to the CDC/SNS in a manner consistent with FDA guidance for EUA of 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.

5.1. For the purpose of procurement, the Offeror’s proposal and SOW shall address the following areas:

5.1.1. Product and facility availability for production and procurement of up to 753,000 FDP treatment courses (TC) with appropriate details as to the Offeror’s expected capacity during the entire period of performance (including option periods). The USG has the discretion to determine the amount of product to be procured based upon the Offeror’s proposal, cost per TC, and availability of funds.

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

5.1.2. A production plan and timeline that describes the facilities, processes, resources and capabilities necessary to manufacture product.

5.2. For initial procurement, the Offeror shall produce BDS in sufficient quantity to allow formulation and fill of up to 153,000 FDP TCs to be stockpiled.

5.3. The Offeror shall store all BDS and FDP in compliance with cGMP until release testing has been completed.

5.4. A delivery plan including the type of product delivered (BDS or FDP), storage location (VMI or

SNS) and schedule will be determined by the USG and Offeror during pre-award negotiations.

6. [OPTIONS] Post-Marketing Commitments/Requirements:

6.1. The Offeror shall commit to comply with Post-Marketing Commitments/Requirements as specified by the FDA. Cost estimates may be based on tentative plans in place prior to direction from the

FDA.

7. [OPTIONS] Additional Procurement Phase 1

7.1. To maintain preparedness, the USG shall at its discretion execute optional additional procurements. The intention of these additional procurement phases will be to augment the existing inventory of Ebola therapeutic MCMs held as VMI or stored in the SNS and/or replace expiring product.

7.2. The type of product (BDS or FDP), storage location (VMI or SNS), volume and pricing of these additional procurement phases will be negotiated during execution of the contract. It is currently estimated that additional procurement under each optional CLIN will not exceed 150,000 FDP TCs or 150,000 FDP TC equivalents of BDS.

8. [OPTIONS] Additional Procurement Phase 2

8.1. To maintain preparedness, the USG shall at its discretion execute optional additional

8.2. The type of product (BDS or FDP), storage location (VMI or SNS), volume and pricing of these

TCs or 150,000 FDP TC equivalents of BDS

9. [OPTIONS] Additional Procurement Phase 3

9.1. To maintain preparedness, the USG shall at its discretion execute optional additional

9.2. The type of product (BDS or FDP), storage location (VMI or SNS), volume and pricing of these

TCs or 150,000 FDP TC equivalents of BDS

10. [OPTIONS] Additional Procurement Phase 4

10.1. To maintain preparedness, the USG shall at its discretion execute optional additional

10.2. The type of product (BDS or FDP), storage location (VMI or SNS), volume and pricing of these estimated that additional procurement under each optional CLIN will not exceed 150,000 FDP TCs or 150,000 FDP TC equivalents of BDS

C.2. REPORTING REQUIREMENTS

See Section F for specific reporting requirements.

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

C.3. MEETINGS/SITE VISITS

The Contractor and BARDA/AMCG 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 and/or teleconferences, site visits to the Contractor’s and/or subcontractor’s facilities, and meetings with individual Contractors and other HHS officials to discuss the technical, regulatory, and ethical aspects of the program. The Contractor 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 Contractor to HHS/BARDA and review contract requirements. This meeting usually occurs within a month after contract award.

Expected bi-weekly or monthly status update meetings/teleconferences. The schedule for these meetings will be established by the CO and COR.

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

Within thirty (30) calendar days of an FDA audit of Contractor or subcontractor facilities, the Contractor 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 Contractor with 48 hours advance notice. The USG reserves the right to accompany the Contractor on routine and for-cause site-visits/audits of subcontractor(s). At the discretion of the USG and independent of testing conducted by the Contractor, BARDA reserves the right to conduct site visits/audits and collect samples of product held by the Contractor and subcontractors.

Pre-award site visits may be made with short notice. Contractors 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 Contractor’s name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

SECTION E – INSPECTION AND ACCEPTANCE

E.1. INSPECTION AND ACCEPTANCE

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

Biomedical Advanced Research and Development Authority Office of the Assistant Secretary for Preparedness and Response 200 C Street, S.W.

Washington, D.C. 20024

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

E.2. FEDERAL ACQUISITION REGULATION CLAUSES INCORPORATED BY REFERENCE

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

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

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

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 contract will consist of a base period of up to five (5) years and up to 10 years with the exercise of options from the date of award. The period of performance may be extended with the exercise of option(s), structured as CLINs, as set forth in SECTION B.

F.2. DELIVERIES

Successful performance of the final contract shall be deemed to occur upon performance of the work described in SECTION C of this RFP and upon delivery and acceptance of the items described in SECTION F.3 by the Contracting Officer or their duly authorized representative.

F.3. CONTRACT DELIVERABLES AND REPORTING REQUIREMENTS

F.3.1. Submission of Contract Deliverables

Documents shall be delivered electronically via email to the Contracting Officer (CO) 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

Jason Bell

HHS/ASPR/AMCG

200 C St. SW Washington, DC 20024 Email: Jason.Bell@hhs.gov

Jason Bell

HHS/ASPR/AMCG

200 C St. SW

Email: Jason.Bell@hhs.gov

UPS/FedEx/Courier USPS Mail Packages

Contracting Officer Representative

HHS/ASPR/BARDA

200 C St. SW Washington, DC 20024 Email: TBD

Contracting Officer Representative

HHS/ASPR/BARDA

200 C St. SW

Email: TBD

F.3.2. Reporting Requirements

In addition to those reports required by other terms of this RFP, the Contractor 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. 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 Contractor 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 Contractor'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). 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.

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 Contractor 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 Contractor's name, address, telephone number, fax number, and e-mail address; and the date of submission.

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

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

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

SECTION II Part B: MANAGEMENT AND ADMINISTRATIVE UPDATE – This section shall include a description of all meetings, conference calls, etc. that have taken place during the reporting period. Include progress on administration and management issues (e.g. evaluating and managing subcontractor 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.

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 Contractor's name, address, telephone number, fax number, and e-mail address; and the date of submission.

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

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

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

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

a. The Contractor shall inform BARDA of all communications with the FDA for this specific product, provide all communications and submissions related to the product, and provide previous correspondences with FDA related to the development of the therapeutic.

b. The Contractor 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 licensure.

c. The Contractor shall obtain FDA concurrence on the regulatory pathway to licensure (i.e.

traditional approval, accelerated approval, or Animal Rule).

d. The Contractor shall conduct all necessary meetings with the FDA to support submission of a BLA/NDA to the FDA and include BARDA staff, as silent observers, in all scheduled phone calls or face to face meetings with regulatory authorities.

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

f. The Contractor shall provide BARDA the opportunity to review and comment upon any documents to be submitted to the FDA or other regulatory agency. The Contractor shall provide BARDA with five (5) business days in which to review and provide comments back to the Contractor prior to the Contractor’s submission to the FDA.

g. The Offeror shall re-label investigational product (upon licensure) to be consistent with the licensed product, in accordance with regulatory requirements. Within five business days of any formal meeting with the FDA or other regulatory agency, the Contractor shall forward the initial draft minutes to BARDA. The Contractor shall forward the final minutes when available.

h. The Contractor 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 Contractor shall provide the USG with an exact copy (non-redacted) of the FDA Form 483 and the Establishment Inspection Report (EIR). The Contractor 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 Contractor shall also provide redacted copies of any FDA audits received from subcontractors that occur as a result of this contract or for this product. The redactions shall be limited to issues that are unrelated to the subcontractor’s performance on any award made under this RFP. The Contractor shall make arrangements with the COR for the appropriate BARDA representative(s) to be present during the final debrief by the regulatory inspector.

i. The Contractor shall forward Standard Operating Procedures (SOPs) upon request from

COR.

j. The Contractor shall provide raw data and/or specific analysis of data generated with USG funds upon request from the COR.

E. Other Requirements/Deliverables

a. Integrated Master Project Plan

The Contractor shall provide an Integrated Master Project Plan (including tabular and Gantt forms) to BARDA 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 Contractor 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 or Co-

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 or Co-COR.

ii. Work Breakdown Structure

The WBS shall be discernable and consistent. BARDA may require the Contractor 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 or Co-COR.

iii. Risk Mitigation Plan/Matrix The Contractor 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 Contractor. This report shall be due within 90 days of contract award. Updates shall be due as requested by the COR or Co-COR.

b. Technology Packages

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

See FAR clauses 52.227-11, Patent Rights-Ownership by the Contractor, and 52.227-14, Rights in Data. This report shall be due upon request from the COR or Co-COR.

c. Experimental Protocols

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

d. Annual/Final Invention Report All reports and documentation required by FAR Clause 52.227-11, Patent Rights- Ownership by the Contractor, 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 30 th 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.

e. 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.

f. Press Releases

The Contractor agrees to accurately and factually represent the work conducted under this contract in all press releases. The Contractor 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 potential press release.

g. Security Report

The Contractor shall report to the government any activity; or incident that is in violation of established security standards; or indicates the loss or theft of government products.

Reports shall be due within 24 hours after occurrence of an activity or incident.

F. Earned Value Management System Plan

a. Earned Value Management System Plan:

Subject to the requirements under FAR 52.234-4 Earned Value Management System, the Contractor shall use principles of Earned Value Management System (EVMS) in the management of this contract (include this plan as part of the monthly, annual, and final reports). The principles of EVM are:

I. Plan all work scope for the program to completion.

II. Break down the program work scope into finite pieces that can be assigned to a responsible person or organization for control of technical, schedule, and cost objectives.

III. Integrate program work scope, schedule, and cost objectives into a performance measurement baseline plan against which accomplishments may be measured. Control changes to the baseline.

IV. Use actual cost incurred and recorded in accomplishing the work performed.

V. Objectively assess accomplishments at the work performance level.

VI. Analyze significant variances from the plan, forecast impacts, and prepare an estimate at completion based on performance to date and work to be performed.

VII. Use earned value information in the company’s management processes.

VIII. Elements of EVMS shall be applied to all CLINs as part of the Integrated Master Project Plan, the Contractor shall submit a written summary of the management procedures that it will establish, maintain and use to comply with EVMS requirements.

b. Performance Measurement Baseline Review (PMBR):

The Contractor shall submit a PMBR plan electronically…