RFP-17-100-SOL-00007.pdf

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 SOLICITATION, OFFER AND `AWARD

1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

RATING

PAGE OF

1 100

2. CONTRACT NO.

N/A

3. SOLICITATION NO.

11-100-SOL-00007

4. TYPE OF SOLICITATION

SEALED BID (IFB)

X NEGOTIATED (RFP)

5. DATE ISSUED

06/19/2017

6. REQUISITION/PURCHASE NO.

7. ISSUED BY CODE 8. ADDRESS OFFER TO (If other than Item 7) Department of Health and Human Services

OS/ASPR/AMCG

330 Independence Ave. SW, Room G640 Washington, DC 20201

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 07/19/2017

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

Dorothy McMillan

B. TELEPHONE (NO COLLECT CALLS)

(202) 260-8541

C. E-MAIL ADDRESS

dorothy.mcmillan@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 50

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

X C DESCRIPTION/SPECS./WORK STATEMENT 12 X J LIST OF ATTACHMENTS 73

X D PACKAGING AND MARKING 23 PART IV – REPRESENTATIONS AND INSTRUCTIONS

X E INSPECTION AND ACCEPTANCE 24 REPRESENTATIONS, CERTIFICATIONS, AND

X F DELIVERIES OR PERFORMANCE 25 X K OTHER STATEMENTS OF OFFERORS 74

X G CONTRACT ADMINISTRATION DATA 36 X L INSTRS., CONDS., AND NOTICES TO OFFERORS 81

X H SPECIAL CONTRACT REQUIREMENTS 39 X M EVALUATION FACTORS FOR AWARD 96

OFFER (Must be fully completed by Offeror) NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

12. In compliance with the above, the undersigned agrees, if this offer is accepted within 120 calendar days (60 calendar days unless a different period is inserted by the Offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the designated point(s), within the time specified in the schedule.

13. DISCOUNT FOR PROMPT PAYMENT

(See Section I, Clause No. 52-232-8)

10 CALENDAR DAYS

20 CALENDAR DAYS

30 CALENDAR DAYS

AMENDMENT NO. DATE AMENDMENT NO. DATE

DUNS 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 CO (Type or print)

27. UNITED STATES OF AMERICA

(Signature of CO)

28. AWARD DATE

IMPORTANT -- Award will be made on this form, or on Standard Form 26, or by other authorized official written notice.

AUTHORIZED FOR LOCAL REPRODUCTION / PREVIOUS EDITION IS UNUSABLE STANDARD FORM 33 (REV. 9-97) / Prescribed by GSA / FAR (48 CFR) 53.214(c)

K

RFP No. HHS-BARDA-08-25

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 the RFP is July 5, 2017 until 12PM EST. All questions shall be submitted via e-mail to Dorothy.McMillan@hhs.gov. The alternate for this RFP is Tasha.McMillan@hhs.gov.

RFP No. 11-100-SOL-00007 2 mailto:Dorothy.McMillan@hhs.gov mailto:Tasha.McMillan@hhs.gov

SECTION B--SUPPLIES OR SERVICES AND PRICES/COSTS

B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The Statement of Work (SOW) contained in Section C of the solicitation package delineates the specifics of the supplies or services to be furnished. The minimum guarantee is $50,000.00 for the duration of any resultant contract (base + options).

Provide firm-fixed prices for all CLINs, except those CLINs which have “TBD” or “N/A” in the Estimated Maximum Quantity column. Provide pricing based upon the CLIN, item name and description in the SOW contained in Section C for the two

(2) year base period, and item name and description for the two 12-month option periods, as the numbers in SOW reflect base period numbering (SOW Numbering identified in SOW would be revised in conjunction with any resultant option award with description data unchanged).

Price/Cost, e.g., Firm-fixed-price or cost reimbursable, for “TBD” CLINs, i.e., 0007F, 0008, 0010, 0011, 0012, 0013, 0014, and 0015 will be determined as a result of the issuance of a Request for Task Order Response (RTOR) to any or all resultant contract awardee(s).

B.2. CONTRACT LINE ITEM NUMBERS (CLINs) (To be completed at the time of contract award)

a. The Contractor shall be reimbursed by the Government in an amount not less than a total of $ (minimum) nor more than a total of $ (maximum) if all optional CLINs are exercised.

b. The prices set forth in this ARTICLE B.2. will cover the contract period from _____________ through _____________.

c. Upon delivery and acceptance of the item(s) described in SECTION C of this contract and identified in the schedule of charges below, the Government shall pay to the Contractor the unit price(s) set forth below.

d. BASE PERIOD: (Contract Award through Twenty-Four (24) Months)

CLIN ITEM NAME UNIT MAXIMUM

QUANTITY

UNIT

PRICE

TOTAL

VALUE

PER 12

MONTH

TOTAL EXTENDED

PRICE

(24 Month Base)

0001 cGMP Influenza Vaccine Master and Working Seed Lot

LOT 15

0002 Influenza Vaccine Research Lot(s)

LOT 15

0003 cGMP Influenza Vaccine Investigational Lot (s)

LOT 15

0004 cGMP Influenza Vaccine Commercial Scale Bulk Lot(s)

LOT 300

0005 cGMP Adjuvant: Clinical or Commercial Scale Bulk Lot(s)

LOT 50

0006A Formulation and Filling:

Antigen—Single-dose vials

EA 10,000,000

0006B Formulation and Filling:

Antigen—Syringes or Sprayers

EA 100,000,000

0006C

Formulation and Filling:

Antigen-Multi-dose vials

EA 10,000,000

RFP No. 11-100-SOL-00007 3

0006D Formulation and Filling:

Adjuvant--Single-Dose Vials

EA 100,000,000

0006E Formulation and Filling:

Adjuvant—Multi-Dose Vials

EA 10,000,000

0006F Formulation and Filling: Co-formulated Antigen and Adjuvant-Single-Dose Vials

EA 10,000,000

0006G Formulation and Filling: Co-formulated Antigen and Adjuvant--Syringes

EA 100,000,000

0006H Formulated and Filling: Co-formulated Antigen and Adjuvant—Multi-Dose Vials

EA 10,000,000

0007A Storage and Stability:

Investigational Lots of Antigen

LOT 20 Per Lot Per Mth

Per Lot/12 mths

Lots/12 mths

0007B Storage and Stability:

Commercial Scale Bulk Lots of Antigen

LOT 100 Per Lot Per Mth

Per Lot/12 mths

20 Lots/12

0007C Storage and Stability: Antigen in Final Container

Final Container

5,000,000 Per FC Per Mth

Per FC/12

5,000,000

FC/12

0007D Storage and Stability:

Clinical/Commercial scale lots of Adjuvant

LOT 400 Per Lot Per Mth

Per Lot/12 mths

Lots/12

0007E Storage and Stability: Adjuvant in Final Container

Final Container

5,000,000 Per FC Per Mth

Per FC/12 mths 5,000,000

FC/12

0007F Storage and Stability:

Licensed Product in Final Package

Package TBD Per PG Per Mth

Per PG/12 mth

0008 Shipping EA TBD

0009 Candidate Vaccine Virus

(CVV)

EA 15

0010 Potency Reagent and Standards Manufacture and Testing

EA TBD

0011 Analytical Laboratory Testing/Assay

EA TBD

0012 Non-Clinical Studies Study TBD

0013 Clinical Studies Study TBD

RFP No. 11-100-SOL-00007 4

0014 Disposal of Product EA TBD

0015 BARDA Tracking Tool- Development and Testing of New Standard Data Reporting Formats

EA TBD

0016 Additional Reporting Report N/A Not Separately Priced

(NSP)

0017A Prior Contracts:

Storage and Stability of Bulk Lots--Antigen

LOT 250

0017B Prior Contracts: Storage and Stability in Final Container - Antigen

Final Container

500,000

0017C Prior Contracts: Storage and Stability of Bulk Lots-Adjuvant

LOT 250

0017D Prior Contracts: Storage and Stability in Final Container-- Adjuvant

Final Container

500,000

Total Estimated Dollar Amount – Base Period (24 Months)

TOTAL CONTRACT VALUE (BASE PERIOD):

e. OPTION PERIOD I: (September xx, 2019 through August xx, 2020)

CLIN ITEM NAME UNIT MAXIMUM

QUANTITY

UNIT

PRICE

TOTAL VALUE

12 MONTH

TOTAL PRICE

0101 cGMP Influenza Vaccine Master and Working Seed Lot

LOT 5

0201 Influenza Vaccine Research Lot(s)

LOT 5

0301 cGMP Influenza Vaccine Investigational Lot (s)

LOT 5

0401 cGMP Influenza Vaccine Commercial Scale Bulk Lot(s)

LOT 100

0501 cGMP Adjuvant: Clinical or Commercial Scale Bulk Lot(s)

LOT 20

0601A Formulation and Filling:

Antigen—Single-dose vials

EA 10,000,000

0601B Formulation and Filling:

Antigen—Syringes or Sprayers

0601C

EA 10,000,000

0601D Formulation and Filling:

Adjuvant--Single-Dose Vials

EA 100,000,000

0601E Formulation and Filling:

Adjuvant—Multi-Dose Vials

EA 10,000,000

0601F Formulation and Filling: Co- EA 10,000,000 RFP No. 11-100-SOL-00007 5 formulated Antigen and Adjuvant-Single-Dose Vials

0601G Formulation and Filling: Co-formulated Antigen and Adjuvant--Syringes

EA 100,000,000

0601H Formulated and Filling: Co-formulated Antigen and Adjuvant—Multi-Dose Vials

EA 10,000,000

0701A Storage and Stability:

Investigational Lots of Antigen

LOT 7

0701B Storage and Stability:

Commercial Scale Bulk Lots of Antigen

LOT 30

0701C Storage and Stability:

Antigen in Final Container

Final Container

5,000,000

0701D Storage and Stability:

Clinical/Commercial scale lots of Adjuvant

LOT 30

0701E Storage and Stability:

Adjuvant in Final Container

Final Container

5,000,000

0701F Storage and Stability:

Licensed Product in Final Package

Package TBD

0801 Shipping EA TBD 0901 Candidate Vaccine Virus

(CVV)

EA 5

1001 Potency Reagent and Standards Manufacture and Testing

EA TBD

1101 Analytical Laboratory Testing/Assay

EA TBD

1201 Non-Clinical Studies Study TBD

1301 Clinical Studies Study TBD 1401 Disposal of Product EA TBD

1501 BARDA Tracking Tool- Development and Testing of New Standard Data Reporting Formats

EA TBD

1601 Additional Reporting Report N/A Not Separately

1701A Prior Contracts:

Storage and Stability of Bulk Lots--Antigen

LOT 250

1701B Prior Contracts: Storage and Stability in Final Container - Antigen

Final Container

500,000

1701C Prior Contracts: Storage and Stability of Bulk Lots- Adjuvant

LOT 250

1701D Prior Contracts: Storage and Stability in Final Container--Adjuvant

Final Container

500,000

Total Estimated Dollar Amount – Option Period I (12 Months)

RFP No. 11-100-SOL-00007 6

f. OPTION PERIOD II: (September xx, 2020 through August xx, 2021)

CLIN ITEM NAME UNIT MAXIMUM

QUANTITY

UNIT

PRICE

TOTAL VALUE

12 MONTH

TOTAL PRICE

1801 cGMP Influenza Vaccine Master and Working Seed Lot

LOT 5

1901 Influenza Vaccine Research Lot(s)

LOT 5

2001 cGMP Influenza Vaccine Investigational Lot (s)

LOT 5

2101 cGMP Influenza Vaccine Commercial Scale Bulk Lot(s)

LOT 100

2201 cGMP Adjuvant: Clinical or Commercial Scale Bulk Lot(s)

LOT 20

2301A Formulation and Filling:

Antigen—Single-dose vials

EA 10,000,000

2301B Formulation and Filling:

Antigen—Syringes or Sprayers

2301C

EA 10,000,000

2301D Formulation and Filling:

Adjuvant--Single-Dose Vials

EA 100,000,000

2301E Formulation and Filling:

Adjuvant—Multi-Dose Vials

EA 10,000,000

2301F Formulation and Filling: Co-formulated Antigen and Adjuvant-Single-Dose Vials

EA 10,000,000

2301G Formulation and Filling: Co-formulated Antigen and Adjuvant--Syringes

EA 100,000,000

2301H Formulated and Filling: Co-formulated Antigen and Adjuvant—Multi-Dose Vials

EA 10,000,000

2401A Storage and Stability:

Investigational Lots of Antigen

LOT 7

2401B Storage and Stability:

Commercial Scale Bulk Lots of Antigen

LOT 30

2401C Storage and Stability:

Antigen in Final Container

Final Container

5,000,000

2401D Storage and Stability:

Clinical/Commercial scale lots of Adjuvant

LOT 30

2401E Storage and Stability:

Adjuvant in Final Container

Final Container

5,000,000

2401F Storage and Stability:

Licensed Product in Final Package

Package TBD

RFP No. 11-100-SOL-00007 7

2501 Shipping EA TBD 2601 Candidate Vaccine Virus

(CVV)

EA 5

2701 Potency Reagent and Standards Manufacture and Testing

EA TBD

2801 Analytical Laboratory Testing/Assay

EA TBD

2901 Non-Clinical Studies Study TBD 3001 Clinical Studies Study TBD 3101 Disposal of Product EA TBD

3201 BARDA Tracking Tool- Development and Testing of New Standard Data Reporting Formats

EA TBD

3301 Additional Reporting Report N/A Not Separately

3401A Prior Contracts:

Storage and Stability of Bulk Lots--Antigen

LOT 250

3401B Prior Contracts: Storage and Stability in Final Container - Antigen

Final Container

500,000

3401C Prior Contracts: Storage and Stability of Bulk Lots- Adjuvant

LOT 250

3401D Prior Contracts: Storage and Stability in Final Container--Adjuvant

Final Container

500,000

Total Estimated Dollar Amount – Option Period II (12 Months)

B.3. CONTRACT TYPE

This is an indefinite-delivery, indefinite-quantity (IDIQ) contract for antiviral drugs. During the ordering period of the contract, authorized officials assigned to the contract may order, and the Offeror shall provide, supplies and services at the unit price listed above.

1. Delivery Order and Task Order Type

Delivery orders and task orders issued under this contract will be firm-fixed price.

2. Minimum and Maximum Quantity

The minimum ordering limitation and Government guarantee under this contract is _____________ at a total value of $____________.

The maximum ordering limitation and Government guarantee under this contract is _____________ at a total value of $____________.

B.4. ADVANCE UNDERSTANDINGS:

RFP No. 11-100-SOL-00007 8

1. The offeror will be responsible for maintaining Government Furnished Property in accordance with FAR 52.245-1.

Invoicing for these CLINS shall be done at a minimum on a quarterly basis.

2. Vendor Production Capacity

Identify lead time from date of order to completion/delivery required by contractor for U/I and to reach maximum manufacturing production that vendor would be able to provide U.S. Government in event of a pandemic (identify maximum production capacity). For purposes of the below table, assume duration of six (6) months for column “Maximum Quantity vendor could produce in event of pandemic.”

CLIN Item Name Unit of Issue Number of

Days/Lead Time from date of Order to Delivery per U/I

Maximum Quantity vendor could produce in event of pandemic

Number of Days Needed from date of Order to Delivery per Maximum Quantity

0001 cGMP Influenza Vaccine Master and Working Seed Lot

Lot

0002 Influenza Vaccine Research Lot(s)

0003 cGMP Influenza Vaccine Investigational Lot(s)

0004 cGMP Influenza Vaccine Commercial Scale Bulk Lot(s)

0005 cGMP Adjuvant: Clinical or Commercial Scale Bulk Lot(s)

0006A

Antigen--Single-dose vials

Each

0006B Formulation and Filling:

Antigen--Syringes or Sprayers

0006C Formulation and Filling:

Antigen--Multi-dose vials

0006D Formulation and Filling:

Adjuvant--Single dose

0006E Formulation and Filling:

Adjuvant--Multi-dose

0006F Formulation and Filling:

Co-formulated antigen

RFP No. 11-100-SOL-00007 9 and adjuvant--Single dose vials

0006G Formulation and Filling:

Co-formulated antigen and adjuvant--Syringes

0006H Formulation and Filling:

Co-formulated antigen and adjuvant--Multi-dose

3. Schedule of Labor Category Hourly Rates for TBD CLINs

Offerors should provide a table of position titles, description of the education level attained and years of relevant experience, and hourly rates. Responses to unpriced CLINs will rely on these tables to evaluate proposed costs. For example:

Position Description Hourly Rate QA-1 B, 3+ years $

QA-2 B, 6+ years; M, 3+ years $

QA-Manager B, 18+ years; M, 12+ years; D, 6+ years $

QA-Director D, 16+ years $

QA-VP D, 20+ years $

Technician-1 H, 6+ years $

H: High School; B: Bachelor; M: Master; D: Doctor Offerors should provide over-head rates specific to the facilities offered.

4. Analytical Laboratory Testing/Assay-CLIN 0011—Pricing per Time Point

Offerors shall provide pricing for below indicated time points:

• Perform stability testing and/or other testing: SRID, HPLC, SDS-Page and Western Blot Test Methods SRID HPLC SDS-Page Western Blot

Time Points 2-8°C

Time Zero

3 months

6 months

9 months

12 months

18 months

RFP No. 11-100-SOL-00007 10

24 months

B.5. MULTIPLE AWARD ORDERING:

Under Indefinite Quantity clause, orders will be issued to all contractors awarded a vaccine stockpile contract for Pandemic Influenza Preparedness and Response. All contractors may receive orders for CLINs up to the minimum guaranteed amount. Additional quantities may be ordered upon the Government’s need and contractor’s ability to produce the requirement.

B.6. 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

RFP No. 11-100-SOL-00007 11

SECTION C – STATEMENT OF WORK

C.1. STATEMENT OF WORK

Background

The potential for a human influenza pandemic continues to be a public health concern. Four influenza pandemics occurred over the last century. In 2009, we completed responded to the most recent pandemic caused by a H1N1 virus.

Sporadic infections of humans with avian influenza viruses with high mortality (H5N1, H7N9) suggest the public is at risk for a severe influenza pandemic. An outbreak of severe pandemic influenza could cause over 60 million deaths worldwide by some estimates.

Pillar One of the National Strategy for Pandemic Influenza (2005) describes the activities to be undertaken before a pandemic to ensure preparedness. The strategy seeks to “establish domestic production capacity and stockpile of countermeasures to ensure sufficient vaccine to vaccinate front-line personnel and at-risk populations”. In the Implementation Plan for the National Strategy for Pandemic Influenza (2006) two primary goals were set “(1) establishment and maintenance of stockpiles of pre-pandemic vaccine adequate to immunize 20 million persons against influenza strains that present a pandemic threat; and (2) expansion of domestic influenza manufacturing surge capacity for the production of pandemic vaccines for the entire domestic population within 6 months of a pandemic declaration”. To accomplish these goals, the Federal Government established stockpiles of influenza countermeasures, as well as domestic vaccine manufacturing capacity. In addition substantial new investments were made in the advanced development of cell-culture-based influenza vaccine candidates, with a goal of establishing the domestic surge vaccine production capacity to meet the pre-pandemic stockpile and post-pandemic vaccine production goals”.

On December 2009 Secretary Sebelius called for the Public Health Medical Countermeasure Enterprise Review which was issued in August 2010 and stated: “The ultimate goal of this review is a modernized countermeasure production process where we have more promising discoveries, more advanced development, more robust manufacturing, better stockpiling, and more advanced distribution practices. In other words, we want to create a system that can respond to any threat at any time”

Vaccination remains the primary countermeasure against pandemic influenza. Supporting the need for ongoing acquisition of novel subtypes of influenza, currently licensed vaccines for influenza are virus subtype specific. It remains uncertain which influenza subtype will cause the next pandemic. As a result, the ability of vaccines in the National Pre-pandemic Influenza Vaccine Stockpile to protect against emerging strains of influenza is unknown.

The 2009 H1N1 influenza pandemic demonstrated how crucial it is to have active contracts with manufacturers to respond to an influenza pandemic event; in 2009 the Federal Government rapidly modified existing stockpile contracts and issued task orders to manufacturers to produce millions of doses of H1N1 influenza vaccine.

This program will serve as a continuation and expansion of the US Pandemic Preparedness Plan which currently includes contracts with five influenza vaccine experienced companies. The competition will be open to companies that are currently licensed for inactivated, recombinant and live attenuated influenza vaccine (LAIV), both seasonal and pandemic.

In addition, competition is open to Contractors that demonstrate a successful experience in the manufacturing of influenza vaccines at commercial scale, have completed Phase 3 clinical studies (including a final Clinical Study Report) for influenza vaccines with a documented US BLA in preparation for an influenza vaccine.

C.2.1. SCOPE OF WORK:

Independently and not as an agent of the US Government (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 Contractor shall:

RFP No. 11-100-SOL-00007 12

1) Provide Medical Countermeasures (MCMs), such as vaccines, for Pandemic Influenza Preparedness and Response or as required in response to a HHS designated Public Health Emergency.

2) Produce vaccines against influenza and influenza strains with pandemic potential

3) Vendor must:

• Hold a US influenza vaccine license OR

• Have developed an influenza vaccine as evidenced by:

o A pivotal Phase 3 final clinical study report AND o Official Minutes from an US FDA Pre-BLA meeting

C.2.2. Detailed Description of Contract Line Item Numbers (CLINs):

Note: Numbers referenced for CLINs below reflect numbers identified for base period of performance.

CLINs will differ for option periods with item name and scope unchanged.

CLIN 0001: cGMP Influenza Vaccine Master and Working Seed Lot

The Contractor shall provide yield optimized master and working seed lots for inactivated, live attenuated or recombinant influenza vaccine product.

The Contractor shall:

• Manufacture Master and Working seeds lots for influenza vaccine using the same facilities, systems, equipment, processes and testing as those described and referenced in the FDA-licensed influenza vaccine or as described in the BLA in preparation, according to current Good Manufacturing Practices (cGMP) as applicable and store at appropriate conditions during lot release testing.

• Manufacture the seed lot using the qualified influenza candidate vaccine virus (CVV) reference strain as specified by HHS.

• Provide seed lot testing results in accordance to specifications as requested by FDA as part of the FDA-licensed influenza product, or the in-process BLA filing.

• Provide seed lot samples to the FDA for identity verification, and other testing as specified by HHS.

• Store seed lots according to FDA cGMP guidelines.

• Conduct stability and other testing as appropriate or specified by HHS.

• Add manufactured seed lots to ongoing inventory reports and controlled storage.

• Submit standard data report ‘MN001’ according to instructions in ‘Reporting Requirements.’

• Provide a final report including, at minimum, the information identified in the Final Report Requirements Table 1.

CLIN 0002: Influenza Vaccine Research Lot(s)

The Contractor shall provide an influenza vaccine small scale, research lot.

The Contractor shall:

• Prepare a research lot as directed by HHS and specified in the RTOR.

• Provide data derived from the manufacturing process.

RFP No. 11-100-SOL-00007 13

• Provide a final report including, at minimum, the information in the Final Report Requirement

Table 1.

CLIN 0003: cGMP Influenza Vaccine: Investigational Lot(s)

The Contractor shall provide influenza vaccine investigational lot(s).

The Contractor shall:

• Manufacture the clinical vaccine lot in manufacturing facilities according to current Good Manufacturing Practices (cGMP) under 21 CFR parts 210, 211, and 600. Use a validated production method for influenza vaccine manufacture that is described and referenced in the FDA license or BLA under preparation.

• Perform lot release product testing of the influenza vaccine using lot release specifications of the FDA-licensed influenza vaccine product or described in the BLA document in preparation. Provide results to HHS.

• Make batch records available for review by HHS.

• Set aside samples for stability testing up to 120 months.

• Storage methods including containers, stoppers, and other relevant storage supplies need to be approved by

HHS.

• Upon Request, submit standard data reports according to instructions in ‘Reporting Requirements.’

• Provide a final report including, at minimum, the information identified in the Final Report Requirements Table 1.

CLIN 0004: cGMP Influenza Vaccine: Commercial Scale Bulk Lot(s)

The Contractor shall provide influenza vaccine bulk product.

The Contractor shall:

• Manufacture the commercial scale bulk vaccine lot in manufacturing facilities according to current Good Manufacturing Practices (cGMP) under 21 CFR parts 210, 211, and 600. Use a validated production method for influenza vaccine manufacture that is described and referenced in the FDA license or BLA under preparation.

• Perform lot release product testing of the influenza vaccine including potency using lot release specifications of the FDA-licensed influenza vaccine product or described in the BLA document in preparation. Provide results to

HHS.

• Set aside samples for stability study testing for up to 120 months. Selection of lots for stability testing will be determined after manufacture is complete and should be approved by HHS.

• Conduct lot release product testing of the influenza bulk vaccine according to the licensed (or in-process BLA documented) product. Provide results to HHS. Make batch records available for review by HHS.

• Storage methods including containers, stoppers, and other relevant storage supplies need to be approved by

HHS

• Submit standard data report ‘MN004’ according to instructions in ‘Reporting Requirements.’

• Provide a final report including, at minimum, the information identified in the Final Report Requirements Table 1.

CLIN 0005: cGMP Adjuvant: Clinical or Commercial Scale Bulk Lot(s)

The contractor shall provide adjuvant bulk product suitable for formulation and filling. Proposed adjuvant shall have completed Phase 2 development in combination with a pandemic or pre-pandemic antigen. Clinical evidence of antigen sparing and/or adjuvant benefit for the pandemic or pre-pandemic antigen is required.

RFP No. 11-100-SOL-00007 14

• Manufacture the bulk adjuvant product at clinical or commercial scale according to current Good Manufacturing Practices (cGMP) under 21 CFR parts 210, 211, and 600, as applicable, and store at appropriate conditions during lot release testing.

• Make available batch records for review by HHS.

• Set aside samples for stability study testing for up to 120 months Selection of lots for stability testing will be determined after manufacture is complete and should be approved by HHS.

• Execute lot release product testing of bulk adjuvant.

• Storage methods including containers, stoppers, and other relevant storage supplies need to be approved by

HHS.

• Upon request, submit standard data reports according to instructions in ‘Reporting Requirements.’

• Provide a final report including, at minimum, the information identified in the Final Report Requirements Table 1.

CLIN 0006: Formulation and Filling

The unit for this item is each (vial, syringe and sprayer)

The contractor shall:

• Formulate and fill influenza antigen and/or adjuvant in final containers specified in CLIN 0006 A-H.

• Formulation, fill-finish activities of vaccine and/or adjuvant shall be carried out at facilities in compliance with FDA-cGMP guidelines and if applicable, in accordance with the formulation and filling requirements that apply to FDA-licensed influenza vaccine product unless otherwise requested, specified and approved by HHS.

• Formulate material at the concentration or dosage determined by HHS.

• Fill each unit to a volume determined by HHS.

• Assure compliance of formulation and filling activities with the license or in-process BLA documentation as required by HHS.

• Assure compliance of filling activities with relevant FDA cGMP guidelines.

• Execute lot release product testing of the final container using lot release specifications of the FDA-licensed influenza vaccine product or in-process BLA.

• Affix labels onto filled final containers with HHS approved text. HHS will require coding on primary containers and secondary packages for product identification, serialization, lot number and expiration dating in accordance with FDA and GS1 / ISO standards.

• Package filled and labeled final containers as required/specified by HHS.

• Set aside final containers for stability study testing for up to 120 months. Selection of lots for stability testing will be determined after manufacture is complete and should be approved by HHS.

• Submit standard data report ‘MN007’ according to instructions in ‘Reporting Requirements.’

• Provide a final report including, at minimum, the information identified in the Final Report Requirements Table 1.

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CLIN 0006A: Antigen: Single dose vials

CLIN 0006B: Antigen: Syringes or sprayers

CLIN 0006C: Antigen: Multi-dose vials

CLIN 0006D: Adjuvant: Single dose vials

CLIN 0006E: Adjuvant: Multi-dose vials

CLIN 0006F: Co-formulated antigen and adjuvant: Single dose vials

CLIN 0006G: Co-formulated antigen and adjuvant: Syringes

CLIN 0006H: Co-formulated antigen and adjuvant: Multi-dose vials

CLIN 0007: Storage and Stability

• Provide temperature controlled storage at the Contractor site approved by HHS, according to cGMP and the Contractor’s product specifications.

• Store bulk lots and final containers physically segregated from other products

• Ensure proper labeling of stored materials as USG property.

• Execute stability testing of stored material in a manner consistent with the stability testing plan approved by HHS. Report interim data and results to HHS on a monthly basis.

• Ensure sufficient representative samples are available at the time of ‘Storage and Stability’ task order award for stability testing for 120 months from the date of manufacture.

• Ensure stored materials are compliant with the Contractor’s internal quality control system and are ready for use in further cGMP governed manufacturing of clinical material or licensed doses as directed by HHS.

• Provide the government access to review the security system in place and request updates as needed.

• Include in monthly report inventory (lot number, number of lots, number of vials), including inventory quantity changes, current quantity, storage facility/location, manufacturing date, latest stability result for potency, date of next expected stability result and the current expiration date (if applicable).

• Ensure that material being relocated for the contractors’ convenience is adequately insured at no cost to the government and with CO approval.

• Conduct testing necessary to ensure continued use of the stored material for pre-pandemic preparation, pandemic response and, where appropriate, manufacture of licensed doses.

• Make appropriate updates to the regulatory documentation supporting the continued use of the stored material for pre-pandemic preparation, pandemic response and, where appropriate, manufacture of licensed doses.

• If using a subcontracted storage site, provide the quality agreement, specify the location and terms of the storage contract and receive approval by HHS.

• Submit standard data reports ‘MN014’ and ‘MN017’ according to instructions in ‘Reporting Requirements.’

• Provide a final report including, at minimum, the information identified in the Final Report Requirements Table 1.

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CLIN 0007A: Storage and Stability of investigational lots of antigen

The unit for this item is a lot, which equals storage and stability for one (1) lot/month.

CLIN 0007B: Storage and Stability of commercial scale bulk lots of antigen

The unit for this item is a lot, which equals storage and stability for one (1) lot/month.

CLIN 0007C: Storage and Stability of antigen in final container

The unit for this item is a final container which equals storage and stability for a single (1) final container/month.

CLIN 0007D: Storage and Stability of clinical/commercial scale lots of adjuvant

The unit for this item is a lot which equals a single (1) month of storage and stability for a single (1) lot/month.

CLIN 0007E: Storage and Stability of adjuvant in final container

The unit for this item is a final container which equals storage and stability for a single (1) final container/month.

CLIN 0007F: Storage of licensed product in final package

The unit for this item is a package, which equals storage and stability for a single (1) package/month.

CLIN 0008: Shipping

The unit for this item is each (any unit of issue identified in SOW)

The Contractor shall:

• Package, handle and ship material to the destination specified in the RTOR.

• Arrange for transit, delivery and insurance of material shipped. Send EDI 856 Advanced Shipping Notices upon request.

• Be responsible for delivering material shipped in a condition fit for its intended use.

• Provide program and contracting offices with (transportation document (e.g. bill of lading and associated documents) upon request.

• Submit standard data report ‘DM002’ according to instructions in ‘Reporting Requirements.’

• Provide a final report including, at minimum, the information identified in the Final Report Requirements Table 1.

• Complete Attachment 3: BARDA Request For Shipment to Clinical Study Sites

CLIN 0009: Candidate Vaccine Virus (CVV)

• Prepare non-GLP and/or GLP influenza candidate vaccine viruses using high yield donor viruses or genes as directed by HHS and specified in the RTOR.

• Perform characterization and provide results of in vitro and in vivo bio-safety level testing as necessary and specified in the RTOR.

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CLIN 0010: Potency reagent and standards manufacture and testing

The Contractor shall provide influenza vaccine reagents and standards.

The Contractor shall:

• As directed by HHS, execute activities related to reagent and standards manufacture and testing including purified HA for antibody production, primary liquid standard antigen reference, secondary antigen reference and antibody production.

• As directed by HHS and specified in the RTOR, develop and produce influenza vaccine reagents and standards for other reagent process (HPLC, Mass Spec and others)

• Provide a final report including, at minimum, the information identified in the Final Report Requirements Table 1.

CLIN 0011: Analytical Laboratory Testing/Assay

The contractor shall:

• Conduct laboratory testing/assay as required by HHS and specified in the RTOR

• Provide costs for testing as described in the Technical/Business Proposal Instruction for CLIN0011.

• Provide a final report including, at minimum, the information identified in the Final Report Requirements Table 1.

CLIN 0012: Non-Clinical Studies

The Contractor shall:

• Conduct non-clinical studies as required by HHS and specified in the RTOR.

• Upon request, submit standard data reports according to instructions in ‘Reporting Requirements’

• Provide a final report including, at minimum, the information identified in the Final Report Requirements Table 1.

CLIN 0013: Clinical Studies

• Conduct Clinical studies as required by HHS and specified in the RTOR.

• Upon request, submit standard data reports according to instructions in ‘Reporting Requirements.’

• Provide a final report including, at minimum, the information identified in the Final Report Requirements Table 1.

• Post-Use Monitoring Data to be collected on the use of the product from other MCM access mechanisms (expanded access or EUA) as required by HHS and specified in the RTOR.

• Upon request, provide serum/tissue aliquots to HHS as directed by HHS for immunological evaluation

CLIN 0014: Disposal of product

The unit for this item is each (lot, vial and package)

The Contractor will dispose of all products related to this contract, as required by the USG.

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• Dispose of product following all federal and state regulations for the appropriate waste category; hazardous waste (thimerosal-containing vaccines), regulated medical waste (LAIV), solid waste (non thimerosal-containing vaccine, non LAIV).

• Provide documentation and reports on the performed and completed disposal activity.

• Upon request, submit standard data reports according to instructions in ‘Reporting Requirements.’

• Provide a final report including, at minimum, the information identified in the final report requirements table 1.

CLIN 0015: BARDA Tracking Tool-Development and Testing of New Standard Data Reporting Formats

Plan and create new data sets for submission to the BARDA Tracking Tool (BTT) as described by contract and/or RTOR.

These are additive to the data sets identified in Section F ‘Reporting Requirements and Deliverables’ For planning purposes, BARDA is considering the following data sets for evaluation and testing with the BARDA Tracking Tool and may add other data sets in the future.

Data Set Description Aligns with CLIN # MN005 Production of Bulk Adjuvant Lots CLIN #0005 MN008 Formulation, Fill and Finish of Adjuvant Lots CLIN #0006D and 0006E MN009 Storage of Bulk Drug Substance CLIN #0007B MN010 Storage of Bulk Adjuvant Lots CLIN #0007D MN012 Storage of Clinical Lots CLIN #0007A MN013 Storage of Final Drug Product CLIN #0007E and 0007E MN018 Storage of Master Seed CLIN #0001 DS002 Disposal of Bulk Drug Substance CLIN #0015 DS006 Disposal of Final Drug Product CLIN #0015

• Conduct testing and validation of new data sets submitted to the BARDA Tracking Tool (BTT) Program as described by contract and/or RTOR. Guidance and instructions regarding new data sets (types of data, what to submit, when to submit, how to submit, frequency of submission) will be provided in the RTOR.

• Upon validation, submit new data set on a recurring basis to the BTT for all materials that are currently under contract and/or incorporated from previous contracts. New data sets, upon validation, become part of Standard Data Report baseline.

• For additional information on the current baseline requirements please review Section F ‘Reporting requirements and Deliverables.’

CLIN 0016: Additional Reporting

• Submit inventory reports, monthly progress reports, executive summaries, Government Property reports, ad hoc reports of urgent developments related to this program and a final report as described in detail in the Reporting Requirements and Deliverables. Provide a final report including, at minimum, the information identified in the final report requirements table.

• In Q1 of each calendar year, submit an updated table describing facility availability to complete all CLIN activities throughout the year. A template will be provided by the CO for completion.

• Respond to information requests from HHS pertaining to the ongoing activities.

• Inform the CO and COR of all issues involving any of the material managed under this contract within three

(3) business days of the incident. An impact assessment and remediation plan shall be provided within twenty (20) business days of the incident.

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• Provide copies of reports from regulatory inspections of facilities proposed under this contract for the completion of CLIN work to the CO and COR within five (5) business days of the inspection or receipt of the report. Provide warning letters to the CO and COR within five (5) business days of receipt.

• Make appropriate updates to the regulatory documentation supporting the continued use of the stored material for pre-pandemic preparation, pandemic response and, where appropriate, manufacture of licensed doses. Submit documentation of regulatory update(s) with the monthly report.

• Provide regulatory documentation as required by HHS.

CLIN 0017: Storage and Stability of materials from prior contracts

• Provide temperature controlled storage at the Contractor site approved by HHS, according to cGMP and the Contractor’s product specifications.

• Store bulk lots and final containers physically segregated from other products

• Ensure proper labeling of stored materials as USG property.

• Execute stability testing of stored material in a manner consistent with the stability testing plan approved by HHS.

Report interim data and results to HHS on a monthly basis.

• Ensure sufficient representative samples are available at the time of ‘Storage and Stability’ task order award for stability testing for 12 months.

• Ensure stored materials are compliant with the Contractor’s internal quality control system and are ready for use in further cGMP governed manufacturing of clinical material or licensed doses as directed by HHS.

• Provide the government access to review the security system in place and request updates as needed.

• Include in monthly report inventory (lot number, number of lots, number of vials), including inventory quantity changes, current quantity, storage facility/location, manufacturing date, latest stability result for potency, date of next expected stability result and the current expiration date (if applicable).

• Ensure that material being relocated for the contractors’ convenience is adequately insured at no cost to the government and with CO approval.

• Conduct testing necessary to ensure continued use of the stored material for pre-pandemic preparation, pandemic response and, where appropriate, manufacture of licensed doses.

• Make appropriate updates to the regulatory documentation supporting the continued use of the stored material for pre-pandemic preparation, pandemic response and, where appropriate, manufacture of licensed doses.

• If using a subcontracted storage site, provide the quality agreement, specify the location and terms of the storage contract and receive approval by HHS.

• Submit standard data reports ‘MN014’ and ‘MN017’ according to instructions in ‘Reporting Requirements.’

• Provide a final report including, at minimum, the information identified in the Final Report Requirements Table 1.

CLIN 0017A: Storage of bulk lots of antigen The unit for this item is a lot, which equals storage and stability for one (1) lot/month.

CLIN 0017B: Storage of antigen in final container The unit for this item is a final container which equals storage and stability for a single (1) final container/month

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CLIN 0017C: Storage of bulk lots of adjuvant

The unit for this item is a lot which equals a single (1) month of storage and stability for a single (1) lot/month

CLIN 0017D: Storage of adjuvant in final container

The unit for this item is a final container which equals storage and stability for a single (1) final container/month.

C.2.3. Additional Requirements

Alternative potency assays may be used when CBER reagents are not available and must be approved by the CO. When reagents become available, potency determination should be bridged to SRID testing. Parallel testing with both assays shall continue for the duration of the stability program to document comparability. Where appropriate and requested by HHS, such comparability documentation may be submitted to FDA to evaluate feasibility of alternate potency testing for lot release under 21 CFR 610.9 Equivalent Methods and Processes.

When a Contractor manufacturers outside the US, manufactured material shall be shipped to the US within 60 days of lot release. An exception to this requirement may be requested from HHS. Shipment of the vaccine and/or adjuvant to the US shall be coordinated with HHS and other offices/agencies involved in importation of vaccines. Importation of bulk vaccine and adjuvant into the US may require testing which shall be performed according to applicable federal guidelines (e.g., FDA, USDA, and/or CDC). The Contractor shall bear all costs for shipping and testing required for import into the US. This requirement can be unilaterally modified by HHS during a public health emergency to allow for international formulation and filling prior to shipment to the US. If the contractor has domestic/international facilities for primary and secondary manufacturing or storage, products must be shipped from/to different facilities at no cost to the US government.

Bulk manufacturing facilities shall be in compliance with appropriate biosafety level bio-containment procedures.

Contractors holding a US license for an influenza vaccine shall perform all activities described in the CLINs according to those of their FDA-licensed influenza vaccine product processes, including but not limited to the same facilities, systems, equipment processes and testing as for the licensed product. In lieu of a licensed processes, Contractors with unlicensed influenza vaccine products that have completed the final clinical study report for their Phase 3 trial and are preparing the BLA shall perform all activities described in the following CLINs using the same facilities, systems, equipment, processes, and testing as those described in the BLA document in preparation.

Only Contractors without a licensed influenza vaccine may use unlicensed processes to perform work described in the CLINs. Contractors that receive licensure during the course of this contract are required to use the licensed processes for the duration of the contract and to ensure that materials previously purchased by Gov’t from vendor prior to license are compliant with the licensed process, to the extent practical or reasonable with HHS approval.

Products manufactured and stored under this contract are ‘Government Property.’ These materials should be maintained in the contractor’s quality and inventory systems, ready for use in the continued manufacture of bulk material or final container doses intended for clinical use or use under the license.

When appropriate, Contractors shall use the same validated facilities, systems, equipment, and manufactured processes for cGMP manufacturing of licensed influenza vaccine and adjuvant product or influenza vaccine and adjuvant product with an in-process BLA.

When appropriate, Contractors shall use the same validated and approved assays and equipment for lot release of influenza vaccine product and final container influenza vaccine products and stability studies.

When appropriate, Contractors shall use the same validated facilities, systems, and equipment suitable for cGMP storage of influenza vaccine and adjuvant products.

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When appropriate, contractors shall use the approved facilities, equipment, and policies to receive, store, utilize, and dispose of bio-hazardous materials in appropriate conditions (e.g. Biosafety Level 2+ as appropriate).

As appropriate, Contractors shall employ approved biosafety measures compliant with WHO biosafety guidelines for influenza vaccine including protective garments, equipment, sufficient monitoring to assure safe handling of potentially hazardous materials for the safety and protection of workers. Contractors shall conduct work under the contract in accordance with all applicable and current Federal, state, and local laws, codes, ordinances and regulations, as well as all PHS Safety and Health provisions.

Notification shall be given to US Government prior to any disposal of material, records, documentation, and/or reports for consultation and disposition.

The Contractor shall allow HHS-designated personnel including BARDA staff to perform on-site auditing, inspection and review of release documents, test results, equipment and facilities when requested by HHS.

Upon request from HHS, HHS staff and/or designees will be on the Contractor’s site to monitor daily activity and progress under the terms of the contract and facilitate discussion between the Contractor and HHS.

Contractors must submit documents as requested by HHS to support the preparation of a pre-EUA document for their vaccine or adjuvant.

RFP No.…