EBOLA_Vaccine_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

1 113

2. CONTRACT NO.

N/A

3. SOLICITATION NO.

17-100-SOL-00013

4. TYPE OF SOLICITATION

SEALED BID (IFB)

X NEGOTIATED(RFP)

5. DATE ISSUED

05/08/2017

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 12:00PM 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

Christopher Scott

a. TELEPHONE (NO COLLECT CALLS)

202-205-8580

b. E-MAIL ADDRESS

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

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 Christopher.Scott@hhs.gov. The backup CO for this RFP is Jason Bell;

he can be reached at Jason.Bell@hhs.gov. Please do not contact or copy Jason Bell unless it is an urgent or important matter and Christopher Scott is unavailable.

mailto:Christopher.Scott@hhs.gov mailto:Jason.Bell@hhs.gov

PART I – THE SCHEDULE

SECTION B – SUPPLIES OR SERVICE AND PRICE / COST

Ebola Vaccine

B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

Medical countermeasures (MCM) against Ebola virus are urgently needed should future outbreaks of this virus occur, similar to the 2014-2015 epidemic in West Africa. The 2014 Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy and Implementation Plan identifies Ebola virus as a high-priority threat as determined by the Secretary of Homeland Security. Strategies to mitigate the threat of Ebola virus include the development of a vaccine suitable for protection against Ebola virus.

BARDA is seeking a vaccine(s) that can be safely and effectively used for the U.S. civilian population in individuals with an elevated risk of exposure to Ebola.

The United States Government (USG) desires a vaccine product(s) to be stored in the Centers for Disease Control and Prevention (CDC) Strategic National Stockpile (SNS), or stored as vendor-managed inventory (VMI), that can meet the PHEMCE product requirements for MCM against Ebola virus.

Candidate vaccines with evidence of an active IND with ongoing or completed Phase 2 or 3 clinical studies and evidence of non-clinical efficacy in a nonhuman primate model of EBOV infection shall be ready for procurement. Under this RFP, BARDA plans to support the purchase of Ebola vaccine(s), which will either be delivered to the SNS or maintained as vendor managed inventory, using Project BioShield (PBS) funds. PBS funds will also support the necessary late-stage development to complete the pathway to licensure of the product(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 Contractor. 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 up to 10 years with the exercise of options. The Base Period includes a Cost Plus Fixed Fee Contract Line Item Number (CLIN) to support late-stage development and a Fixed Price CLIN to support the purchase of vaccine regimens. One of the options will be dedicated to post-marketing commitments as established by the FDA. The other 12 options allow the purchase of additional regimens of vaccine. 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 CLINs

CLIN Supplies/Services Estimated Cost

Fixed Fee Cost + Fixed Fee (CPFF)

0001 (Base) Development and licensure product through the FDA

TBD TBD TBD

Base Period Fixed Price CLINs

CLIN Supplies/Services Regimens (# of Product)

Unit Price

Total ($)

0002 (Base) Initial purchase, storage, and delivery of product to a SNS sight, or initial purchase and storage by the Contractor

B.2.2. OPTIONS

Optional Cost Reimbursement CLINs

CLIN Supplies/Services Estimated Cost

Fixed Fee Cost + Fixed Fee

(CPFF)

0003 (Option) Phase IV post-marketing commitments (this is an option that may or may not be exercised as required by the FDA)

Optional Fixed Price CLINs

CLIN Supplies/Services Regimens (# of Product)

Unit Price

Total

0004 (Option) Surge Capacity – Additional procurement and storage of bulk drug substance, pre-licensure

TBD TBD TBD

0005 (Option) Surge Capacity – Supplemental payment for bulk drug substance (procured under CLIN0004), post licensure

TBD TBD TBD

0006 (Option) Surge Capacity –Fill/finish and storage of final drug product (from bulk drug substance procured under

CLIN0004)

TBD TBD TBD

0007 (Option) Surge Capacity – Additional procurement and storage of bulk drug substance, pre-licensure

TBD TBD TBD

0008 (Option) Surge Capacity – Supplemental payment for bulk drug substance (procured under CLIN0007), post licensure

TBD TBD TBD

0009 (Option) Surge Capacity – Fill/finish and storage of final drug product (from bulk drug substance procured under

CLIN0007)

TBD TBD TBD

0010 (Option) Surge Capacity – Additional procurement and storage of bulk drug substance, pre-licensure

TBD TBD TBD

0011 (Option) Surge Capacity – Supplemental payment for bulk drug substance (procured under CLIN0010), post licensure

TBD TBD TBD

0012 (Option) Surge Capacity – Fill/finish and storage of final drug product (from bulk drug substance procured under

CLIN0010)

TBD TBD TBD

0013 (Option) Surge Capacity – Additional procurement and storage of bulk drug substance, pre-licensure

TBD TBD TBD

0014 (Option) Surge Capacity – Supplemental payment for bulk drug substance (procured under CLIN0013), post licensure

TBD TBD TBD

0015 (Option) Surge Capacity – Fill/finish and storage of final drug product (from bulk drug substance procured under

CLIN0013)

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 vaccine against Viral Hemorrhagic Fever (VHF) caused by Ebola virus. The objective of this RFP will be to procure up to 1.13 million regimens of a vaccine(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; EBOV, 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 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 is also often 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.

The 2014-2015 EBOV epidemic in West Africa highlighted the impact that EBOV can have on public health, with greater than 28,000 confirmed cases and more than 11,300 deaths. MCM for EBOV are urgently needed should an outbreak occur in the future. The resulting product(s) would be procured using Project BioShield (PBS) funds. In the event of a declared emergency prior to licensure of the vaccine by the Food and Drug Administration (FDA)/Center for Biologics Evaluation and Review (CBER), it is anticipated that the investigational product(s) may be administered under an Emergency Use Authorization (EUA) held by the CDC or BARDA.

In July 2014, Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) issued the "Product-Specific Requirements for Medical Countermeasures for Marburg and Ebola Virus Diseases". The document defines the product requirements for both post-exposure prophylaxis (PEP) and therapeutic treatment of infections caused by an intentional large-scale release of Ebola virus. In 2006, the Department of Homeland Security (DHS) determined that Ebola virus is a material threat to national health security.

BARDA is seeking to procure a vaccine(s) against EBOV. HHS/ASPR/BARDA has supported the advanced research and development of four different EBOV vaccine candidates. Other HHS and DoD programs have also funded EBOV vaccine efforts and multiple EBOV vaccine candidates have entered clinical development.

The United States Government (USG) desires a vaccine(s) that can meet the PHEMCE product requirements for MCM against EBOV exposure. This RFP will also support the necessary late-stage development to achieve licensure of the product(s) being procured.

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 up to 1,130,000 regimens of a vaccine against EBOV.

The vaccine(s) shall either be delivered to the Centers for Disease Control and Prevention Strategic National Stockpile (CDC/SNS), or maintained as vendor-managed inventory (VMI) as determined by BARDA and the Contracting Officer. The regimen shall be provided as Final Drug Product (FDP) and a mix of FDP and Bulk Drug Substance (BDS) that shall be filled as needed. The USG is seeking a product(s) that may be administered under an Emergency Use Authorization (EUA) held by the CDC/SNS or VMI if an emergency is declared in response to a future outbreak.

The scope of the base period will include late-stage development activities necessary to support product licensure, and initial purchase of vaccine regimens. Options will include Phase 4 Post- Marketing Commitments and incremental purchases of vaccine regimens as needed.

The statement of objectives are 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: 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)

Section 8: Additional Procurements (Option)

Section 9: Additional Procurements (Option)

Section 10: 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. Program and Risk Management Objectives

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

F.3.2.E and F.3.2.F.

3.1.2. The Offeror shall develop and maintain a risk mitigation plan that is acceptable to the CO and COR. This shall include a risk matrix per attachment 13.

3.1.3. 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.

4. Late stage Product Development Objectives

4.1. General Product Development Objectives

4.1.1. The Offeror shall provide a draft Target Product Profile (TPP) which will be further developed through discussion and negotiation with BARDA and/or FDA.

4.1.2. The product shall have an indication for protection against disease caused by EBOV.

4.1.3. The product shall have an indication for use in healthy adults (Ages 18-65).

4.1.4. The product shall have a minimum of three years stability at the intended storage temperature.

4.1.5. The product shall be able to be manufactured at a scale capable of meeting the USG requirements for stockpiling. Please see the quantities of vaccine regimens noted in Section L.

4.2. Regulatory Objectives

4.2.1. The Offeror shall submit a Quality Management System (QMS) plan and a regulatory master plan for obtaining product licensure as directed and approved by the COR and CO. The plan shall include risk evaluation and address outstanding items identified by FDA (toxicology, non-clinical and clinical studies, and manufacturing activities).

4.2.2. 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 licensure.

4.2.3. The Offeror shall obtain FDA concurrence on the regulatory pathway to licensure (i.e.

traditional approval, accelerated approval, or Animal Rule).

4.2.4. The Offeror shall conduct all necessary meetings with the FDA to support submission of a Biologics License Application (BLA) to the FDA.

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

4.2.6. The Offeror shall develop a Phase 4 post-marketing plan that shall continue monitoring for safety and efficacy in anticipation of FDA guidance for PMCs.

4.3. Non-Clinical Objectives

The Offeror(s) shall demonstrate that the product is non-toxic in key toxicology studies and effective as a prophylaxis against infection by EBOV. Non-clinical study data shall support FDA licensure of the product against EBOV.

4.3.1. The Offeror shall conduct any FDA required efficacy studies to support FDA licensure.

4.3.2. The Offeror shall conduct any FDA required toxicity studies to support FDA licensure.

4.4. Clinical Objectives

The Offeror(s) shall demonstrate that the product is safe in human clinical trials and immunogenic as measured by immunological assays to support product development. Human safety and immunogenicity studies shall be adequate to support FDA licensure of the product against EBOV.

4.4.1. The Offeror shall complete any remaining Phase 3 clinical studies and evaluate critical biological outcomes using validated assays as directed by the BARDA/FDA.

4.4.2. The Offeror shall demonstrate correlation between clinical and non-clinical studies if warranted by the regulatory path per BARDA/FDA guidance.

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 any remaining manufacturing and quality control activities needed to support FDA licensure.

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

4.5.4. The Offeror shall demonstrate capability and compliance for all required CMC activities.

These include but are not limited to those listed below:

4.5.4.1. 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 to support FDA licensure.

4.5.4.2. 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.

4.5.4.3. 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.

4.5.4.4. 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. Procurement and Delivery of Product Objectives

The Offeror(s) shall provide an initial shipment of product, up to 60,000 regimens of a prophylaxis 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. The Offeror shall produce up to 60,000 vaccine regimens as the initial quantity to be stockpiled.

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 CDC/SNS or maintained as vendor-managed inventory (Please propose price per dose for both VMI and 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 CLIN 0003):

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

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

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

7. Additional Procurement (Option CLINs 0004-0006):

The estimate to be procured for option CLINs 0004 through 0006 is up to 240,000 regimens.

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 dose tables for both VMI and SNS.

7.1. To maintain preparedness, the USG shall at its discretion execute optional additional procurements (See Section 5 for applicable requirements). This option CLIN (0004) shall support procurement of BDS prior to licensure of the vaccine by the FDA.

7.2. Option CLIN 0005 shall support supplemental payment for BDS procured under CLIN 0004. This CLIN would be exercised upon licensure of the vaccine.

7.3. Option CLIN 0006 shall support the fill/finish and procurement of FDP from the BDS procured under option CLIN 0004.

8. Additional Procurement (Option CLINs 0007-0009):

The estimate to be procured for option CLINs 0007 through 0009 is up to an additional 240,000 regimens. 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 dose tables for both VMI and SNS.

8.1. To maintain preparedness, the USG shall at its discretion execute optional additional procurements (See Section 5 for applicable requirements). This option CLIN (0007) shall support

8.2. Option CLIN 0008 shall support supplemental payment for BDS procured under CLIN 0007. This CLIN shall be exercised upon licensure of the vaccine.

8.3. Option CLIN 0009 shall support the fill/finish and procurement of FDP from the BDS procured under option CLIN 0007.

9. Additional Procurement (Option CLINs 0010-0012):

The estimate to be procured for option CLINs 0010 through 0012 is up to an additional 240,000 procured based on availability of funds. These efforts include manufacturing, stability testing, and storage. Please propose price per dose tables for both VMI and SNS.

9.1. To maintain preparedness, the USG shall at its discretion execute optional additional procurements (See Section 5 for applicable requirements). This option CLIN (0010) shall support

9.2. Option CLIN 0011 shall support supplemental payment for BDS procured under CLIN 0010. This

9.3. Option CLIN 0012 shall support the fill/finish and procurement of FDP from the BDS procured under option CLIN 0010.

10. Additional Procurement (Option CLINs 0013-0015):

The estimate to be procured for option CLINs 0013 through 0015 is up to an additional 350,000 procured based on availability of funds. These efforts include manufacturing, stability testing, and storage. Please propose price per dose tables for both VMI and SNS.

10.1. To maintain preparedness, the USG shall at its discretion execute optional additional procurements (See Section 5 for applicable requirements). This option CLIN (0013) shall support

10.2. Option CLIN 0014 shall support supplemental payment for BDS procured under CLIN 0013. This

10.3. Option CLIN 0015 shall support the fill/finish and procurement of FDP from the BDS procured under option CLIN 0013.

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 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 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 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. 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 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 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 52.246-4, 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 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 10 years 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/AMCG

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

Contracting Officer

HHS/ASPR/AMCG

200 C St. SW

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

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, 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 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. 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.

b. 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.

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

d. 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.

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

COR.

f. The Contractor shall provide raw data and/or specific analysis of data generated with

USG funds upon request from the COR.

g. 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.

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.

h. Security Plan Please see attachments 15 and 16 for security requirements and a template for the

Security Plan.

i. Quality Management System Plan

The Contractor shall submit to the COR a Quality Management System Plan for BARDA approval no later than 60 days from the date of award.

j. Manufacturing Plan The Contractor shall submit to the COR a comprehensive manufacturing plan for BARDA approval no later than 60 days from the date of award.

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 via email to the CO and COR for a PMBR to occur within 90 days of contract award. At the PMBR, the Contractor and BARDA shall mutually agree upon the budget, schedule and technical plan baselines (Performance Measurement Baseline). These baselines shall be the basis for monitoring and reporting progress throughout the life of the contract.