RFP SOW-New Stockpile 6-29-2021 - Amendment 1.pdf

SOLICITATION, OFFER AND

AWARD

1. THIS CONTRACT

IS A RATED

ORDER UNDER

DPAS (15 CFR 700)

RATING PAGE OF PAGES

1 2

2. CONTRACT NUMBER 3. SOLICITATION

NUMBER

75A50121R00013

4. TYPE OF

SOLICITATION

SEALED BID

(IFB)

X

NEGOTIATE

D (RFP)

5. DATE

ISSUED

06/29/2021

6.

REQUISITION/PURCHAS

E NUMBER

7. ISSUED BY

CO

DE

ASPR-BARDA 8. ADDRESS OFFER TO (If other than Item 7)

ASPR-BARDA

200 Independence Ave., S.W. Room

640-G

Washington DC 20201

NOTE: In sealed bid solicitations "offer" and "offeror" mean "bid" and "bidder".

SOLICITATION

9. Sealed offers in original and copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if hand carried, in the depository located in until 1200 ET local time

(Ho ur)

08/24/2021 (Da te)

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

INFORMAT

ION

CALL:

A. NAME

DEITRA S WILLIAMS

B. TELEPHONE (NO

COLLECT CALLS)

C. E-MAIL ADDRESS

Deitra.Williams@hhs.gov

AREA

CODE

NUMBER EXT.

11. TABLE OF CONTENTS

X

SEC

DESCRIPTION PAGE(S

(X) SE

C.

DESCRIPTION PAGE(S

PART I - THE SCHEDULE PART II - CONTRACT CLAUSES

X A SOLICITATION/CONTRACT FORM 01 X I CONTRACT CLAUSES 46

X B SUPPLIES OR SERVICES AND

PRICES/COSTS

02 PART III - LIST OF DOCUMENTS, EXHIBITS AND

OTHER ATTACH.

X C DESCRIPTION/SPECS./WORK

STATEMENT

12 X J LIST OF ATTACHMENTS 51

X D PACKAGING AND MARKING 21 PART IV - REPRESENTATIONS AND INSTRUCTIONS

X E INSPECTION AND ACCEPTANCE 22 X K REPRESENTATIONS,

CERTIFICATIONS AND

OTHER STATEMENTS OF

OFFERORS

X F DELIVERIES OR PERFORMANCE 23

X G CONTRACT ADMINISTRATION DATA 30 X L INSTRS., CONDS., AND NOTICES TO

OFFERORS

X H SPECIAL CONTRACT REQUIREMENTS

34 X M EVALUATION FACTORS FOR AWARD 66

mailto:Deitra.Williams@hhs.gov

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 0 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.

AWARD (To be completed by government)

19. ACCEPTED AS TO ITEMS

NUMBERED

20. AMOUNT 21. ACCOUNTING AND APPROPRIATION

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN

COMPETITION:

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)

CO

DE

25. PAYMENT WILL BE MADE BY

CO

DE

26. NAME OF CONTRACTING OFFICER (Type or print)

WENDELL CONYERS

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.

AUTHORIZED FOR LOCAL REPRODUCTION

Previous edition is unusable

STANDARD FORM 33 (Rev.

9-97)

Prescribed by GSA - FAR (48 CFR) 53.214(c)

13. DISCOUNT FOR PROMPT PAYMENT

(See Section I, Clause No. 52.232.8)

10 CALENDAR DAYS (%) 20 CALENDAR DAYS (%) 30 CALENDAR DAYS (%) CALENDAR DAYS (%)

14. ACKNOWLEDGEMENT OF AMENDMENTS

(The offeror acknowledges receipt of amendments to the SOLICITATION for offerors and related documents numbered and dated):

AMENDMENT NO. DATE AMENDMENT NO. DATE

15A. NAME

AND

ADDRESS

OF

OFFEROR

CODE

FACILITY

16. NAME AND TITLE OF PERSON AUTHORIZED TO SIGN OFFER

(Type or print)

15B. TELEPHONE NUMBER 15C. CHECK IF REMITTANCE ADDRESS

IS DIFFERENT FROM ABOVE - ENTER

SUCH ADDRESS IN SCHEDULE.

17. SIGNATURE 18. OFFER DATE

AREA CODE NUMBER EXT.

CONTINUATION

SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED

75A50121R00013

PAGE OF

2 2

NAME OF OFFEROR OR CONTRACTOR

ITEM

NO.

(A)

SUPPLIES/SER

VICES

(B)

QUANT

ITY

(C)

UN

IT

(D)

UNIT

PRICE

(E)

AMOUNT

(F)

Period of Performance: 08/25/2021 to 08/24/2025

NSN 7540-

01-152-8067

OPTIONAL FORM 336 (4-

86)

Sponsored by GSA

FAR (48

CFR)

53.110

RFP #75A50121R00013

NOTE TO OFFERORS

The information in SECTION A - Solicitation/Contract Form, contains important information for any Offeror interested in responding to this solicitation. Any contract resulting from this solicitation will include in its SECTION A - Solicitation/Contract Form, accounting, appropriation and general information applicable to the contract award.

If your proposal is not received by the Contracting Officer (CO) or his/her designee at the time and place specified, it will be considered late and handled in accordance with the Federal Acquisition Regulation (FAR), FAR 52.215-1 (Instructions to Offerors – Competitive Acquisition), the Health and Human Services Acquisition Regulation (HHSAR), and HHSAR Clause 352.215-70, “Late Proposals and Revisions” located in section L of this solicitation.

Potential 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 K, 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 regarding the RFP is Tuesday, July 13 Thursday, July 29, 2021 by 12 noon EST. All questions shall be submitted via e-mail to Wendell.Conyers@hhs.gov. The alternate for this RFP is Deitra.Williams@hhs.gov.

mailto:Wendell.Conyers@hhs.gov mailto:Deitra.Williams@hhs.gov

PART I — THE SCHEDULE

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The Department of Health and Human Services (HHS), Office of the Assistant Secretary for Preparedness and Response (ASPR), Biomedical Advanced Research and Development Authority (BARDA) requires the Contractor (s) to furnish all the necessary services, qualified personnel, materials, supplies, equipment and facilities (US facilities preferred) not otherwise provided by the United States Government (USG) as needed to (1) Provide Medical Countermeasures (MCMs), such as vaccines and adjuvants, for Pandemic Preparedness and Response or as required in response to an HHS designated Public Health Emergency;

(2) Produce vaccines against influenza virus, and influenza virus strains with pandemic potential; (3) Produce vaccines and adjuvants to support USG efforts to modernize influenza virus vaccines (for which feasibility data is available), examples may include the reduction in time from viral sequence identification of an influenza virus strain of interest to availability of first doses of vaccine, expanded vaccine delivery options, and other approaches to produce and deliver more vaccine doses in less time; and (4) For influenza, Contractor must demonstrate successful experience in the manufacturing of influenza vaccine by Hold a US influenza virus vaccine license or Have Developed an influenza vaccine as evidenced by submission of a BLA to the US FDA for seasonal or pandemic influenza virus vaccine.

The above-listed requirements are consequently equivalent to the priorities of the Influenza and Emerging Diseases Division (IEDD) among other entities (i.e., the National Strategy for Pandemic Influenza (November 2005), the National Pandemic Influenza Implementation Plan (May 2006), HHS Pandemic Influenza Implementation Plan (2006), The Public Health Emergency Medical Countermeasures Enterprise Review (August 2010), the President's Council of Advisors on Science and Technology report on influenza vaccine manufacturing (August 2010), the BARDA Strategic Plan 2011-2016 (October 2011), HHS H1N1 Influenza Improvement Plan (2012), the HHS Pandemic Influenza Plan (June 2017), and 2017- 2018 Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy and Implementation Plan (SIP)).

The Federal Government has established stockpiles of pre-pandemic influenza countermeasures, domestic vaccine manufacturing capacity, and procure vaccine interventions, including vaccines and therapeutics, to mitigate the public health impact of emerging disease threats. The purpose of this procurement is to keep current the stockpiling material as part of the USG plan to reduce significant morbidity and mortality caused by pandemic influenza or emerging diseases.

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 three (3) 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., 0008, 0010, 0011, 0012, 0013, and 0014 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. Any product made under this contract is a deliverable to the USG. Upon delivery and acceptance of the item(s) described in SECTION C Statement of Work, and identified in the schedule of charges below, the Government shall pay to the Contractor the unit price(s) set forth below. Note the anticipated contract type for each CLIN (Firm Fixed Price and Cost Reimbursable)

d. BASE PERIOD (Contract Award through Thirty-Six (36) Months): August xx, 2021 to August xx, CLIN ITEM NAME Type UNIT MAXIMUM

QUANTITY

UNIT

PRICE

TOTAL

VALUE

PER 12

MONT

H

TOTAL

EXTENDE

D PRICE

(36 Month Base)

0001 cGMP Influenza LOT 15

Vaccine: Master and Working Seed Lot

FFP

Influenza Vaccine Research Lot(s)

FFP

LOT 15

cGMP Influenza Vaccine:

Investigational Lot (s)

LOT

Vaccine:

Commercial Scale Bulk Lot(s) cGMP Adjuvant:

Clinical or

0006A

Formulation and Filling: Antigen— Single-dose vials

EA 100,000,00

0006B

Filling: Antigen— Syringes or Sprayers

EA

100,000,00

0006C

Filling: Antigen- Multi-dose vials

10,000,000

0006D

Filling: Adjuvant-- Single-Dose Vials

0006E

Filling: Adjuvant— Multi-Dose Vials

0006F

Filling: Co-formulated Antigen and Adjuvant-

0006G

Filling: Co-formulated Antigen and Adjuvant-- Syringes

0006H

Formulated and Filling: Co-formulated Antigen and Adjuvant—

0007A

Storage and Stability:

Investigational Lots of Antigen

Per Lot Per Mth

Per Lot/12 mths

0007B Storage and LOT 100 Per Lot Per

Stability:

Commercial Scale Bulk Lots of Antigen

Per Mth Lot/12

0007C

Stability: Antigen in Final Container

Final

Containe r

5,000,000

Per FC

Per

FC/12

0007D

Stability:

Clinical/Commercia l Scale lots of Adjuvant

Per Lot

Per Lot/12

0007E

Stability: Adjuvant

Per FC

Per

FC/12

0008 Shipping Cost

EA TBD

Candidate Vaccine Virus (CVV)

EA 15

Potency Reagent and Standards Manufacture and Testing

TBD

Analytical Laboratory Testing/Assay

Non-Clinical Studies

Study TBD

Clinical Studies

Study

0014 Disposal of Product Cost

Standard Data Reporting

NSP

Monthly

NA

Not Separatel y Priced

(NSP)

Additional

Report

N/A

Separatel

0017A

Related Contracts:

Storage and Stability of Bulk Lots--Antigen

0017B

Contracts:

Storage and Stability in Final Container - Antigen

500,000

0017C Related Contracts:

LOT 250

Stability of Bulk Lots-Adjuvant

0017D

Contracts:

Storage and Stability in Final Container--

Emerging Pathogen

Unprice d

Unpriced

Total Estimated Dollar Amount – Base Period (36 Months)

TOTAL CONTRACT VALUE (BASE PERIOD):

e. OPTION PERIOD I: (August xx, 2024 through August xx, 2025)

CLIN ITEM NAME TYPE UNIT MAXIMUM

UNIT

PRICE

TOTAL

VALUE

PER 12

MONT

H

TOTAL

EXTENDE

D PRICE

(12 Month)

Vaccine: Master and Working Seed Lot

Influenza Vaccine:

Vaccine:

Investigational Lot (s)

Vaccine:

Clinical or

1006A

Single dose vials

1006B

Filling: Antigen— Syringes or

1006C

1006D Formulation and EA 100,000,00

FFP 0

1006E

1006F

Filling: Co-formulated Antigen and Adjuvant-

1006G

Filling: Co-formulated Antigen and Adjuvant-- Syringes

1006H

Filling: Co-formulated Antigen and Adjuvant—

1007A

Stability:

Investigational Lots of Antigen

1007B

Stability:

Commercial Scale Bulk Lots of

1007C

Stability: Antigen in Final Container

FFP Final

1007D

Stability:

Clinical/Commercia l Scale lots of

1007E

Stability: Adjuvant

1008 Shipping Cost EA TBD

Candidate Vaccine Virus (CVV)

EA 5

Potency Reagent and Standards Manufacture and Testing

Analytical Laboratory Testing/Assay

Non-Clinical Studies

Study TBD

1013 Clinical Studies Cost Study TBD 1014 Disposal of Product Cost EA TBD

Standard Data

Monthly

Separatel

Additional

Separatel

1017A

“Related Contracts”:

Storage and Stability of Bulk Lots--Antigen

1017B

Contracts”:

Storage and Stability in Final Container - Antigen

FFP

Final

1017C

Contracts”:

Storage and Stability of Bulk Lots-Adjuvant

1017D

Contracts”:

Storage and Stability in Final Container-- Adjuvant

FFP

Final

Emerging Pathogen

Unprice d

Unpriced

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

f. OPTION PERIOD II: (August xx, 2025 through August xx, 2026)

CLIN ITEM NAME TYPE UNIT MAXIMUM

UNIT

PRICE

TOTAL

VALUE

PER 12

MONTH

TOTAL

EXTENDED

PRICE

(12 Month)

Vaccine: Master and Working Seed Lot

FFP LOT

Influenza Vaccine:

Vaccine:

Investigational Lot (s)

Vaccine: Commercial Scale Bulk Lot(s)

Clinical or Commercial Scale Bulk Lot(s)

2006A

LOT 100,000,000

Single-dose vials

2006B

Syringes or Sprayers

100,000,000

2006C

Filling: Antigen-Multi- Dose Vials

2006D

2006E

2006F

Filling: Co-formulated Antigen and Adjuvant-

2006G

Filling: Co-formulated Antigen and Adjuvant- -Syringes

2006H

Filling: Co-formulated Antigen and Adjuvant—Multi-Dose

Vials

2007A

Storage and Stability:

Investigational Lots of

2007B

Bulk Lots of Antigen

2007C

Antigen in Final Container

2007D

Clinical/Commercial Scale lots of Adjuvant

2007E

Adjuvant in Final

2008 Shipping Cost EA TBD

Candidate Vaccine Virus (CVV)

EA 5

Potency Reagent and Standards Manufacture and Testing

Analytical Laboratory Testing/Assay

2012 Non-Clinical Studies Cost Study TBD 2013 Clinical Studies Cost Study TBD 2014 Disposal of Product Cost EA TBD 2015 Standard Data Report N/A Not

Reporting NSP Separately Priced

Additional Reporting

Separately

Priced

2017A

“Related Contracts”:

Storage and Stability of Bulk Lots--Antigen

2017B

Storage and Stability in Final Container -

2017C

Storage and Stability of Bulk Lots-Adjuvant

2017D

Storage and Stability in Final Container--

2018 Emerging Pathogen Unpriced Unpriced

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

B.3. CONTRACT TYPE

The Government contemplates awarding of multiple Indefinite delivery and indefinite quantity (ID/IQ) hybrid contracts with firm-fixed-price and cost reimbursable task/delivery orders for vaccines for influenza and/or emerging pathogens.

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 negotiated unit price.

1. Delivery Order and Task Order Type

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

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:

The final contract may contain advance understandings between the Government and the Offeror. Specific elements of cost, which normally require prior written approval of the Contracting Officer before incurrence of the cost will be included in this Section if the Contracting Officer has granted his/her approval prior to contract award.

1. The table below shows the Base Year, Option 1 and Option 2 CLINs that may be invoiced after acceptance of products by the Contracting Officer.

Base Period Option 1 Option 2

FFP CLNs FFP CLNs FFP CLNs

0001 to 0007E, 0017A to

0017D

1001 to 1007E, 1017A to 1017D

2001 to 2007E, 2017A to 2017D

Cost CLINs Cost CLINs Cost CLINs

0008 to 0014 1008 to 1014 2008 to 2014

2. 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.

3. Vendor Production Capacity

Identify lead time from date of order to completion/delivery required by contractor for U/I (Unit of Issue) 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 cGMP Influenza Vaccine Master and Working Seed Lot

Influenza Vaccine

Investigational Lot(s)

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

0006A

Formulation and Filling:

Antigen--Single-dose vials

Each

0006B Formulation and Filling: Each

Antigen--Syringes or

0006C

Antigen--Multi-dose vials

0006D

Adjuvant--Single dose

0006E

Adjuvant--Multi-dose

0006F

Co-formulated antigen and adjuvant--Single dose vials

0006G

Co-formulated antigen and adjuvant--Syringes

0006H

Co-formulated antigen and adjuvant--Multi-dose

4. 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 TBD and unpriced CLINs will rely on these tables to evaluate proposed costs. The table below is for example purposes only:

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

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

Offerors shall provide pricing for below indicated time points:

a. 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

24 months

6. Invoices - Cost and Personnel Reporting, and Variances from the Negotiated Budget

a. The Contractor agrees to provide a detailed breakdown on invoices of the following cost categories:

• Direct Labor - List individuals by name, title/position, hourly/annual rate, level of effort, and amount claimed.

• Fringe Benefits - Cite rate and amount

• Overhead - Cite rate and amount

• Materials & Supplies - Include detailed breakdown when total amount is over $1,000.

• Travel - Identify travelers, dates, destination, purpose of trip, and amount. Cite Course of

Action (COA), if appropriate. List separately, domestic travel, general scientific meeting travel, and foreign travel.

• Consultant Fees - Identify individuals and amounts.

• Subcontracts - Attach subcontractor invoice(s).

• Equipment - Cite authorization and amount.

• General and Administrative (G&A) - Cite rate and amount.

• Total Cost

• Fixed Fee

• Total CPFF

Monthly invoices must include the cumulative total expenses to date, adjusted (as applicable) to show any amounts suspended by the Government.

b. The Contractor agrees to immediately notify the Contracting Officer in writing if there is an anticipated overrun (any amount) or unexpended balance (greater than 10 percent) of the amount allotted to the contract, and the reasons for the variance. Also refer to the requirements of the Limitation of Funds and Limitation of Cost Clauses in the contract.

B.5. MULTIPLE AWARD ORDERING:

Under Indefinite Quantity clause, orders will be issued to all contractors awarded a contract under this solicitation. All contractors may receive orders for CLINs up to the minimum guaranteed amount.

Additional quantities may be ordered based upon the Government’s need and contractor’s ability to produce the requirement.

B.6. ORGANIZATIONAL CONFLICT OF INTEREST

a. General: For the purpose of this provision/clause, “consultant” is defined as a company, firm, LLC, sole proprietor, joint venture member, independent contractor, subcontractor, affiliate, or similar entity that is not an employee of the Contractor.

b. Disclosure: The Contractor shall report contacts with consultants who are paid to furnish advice, information, direction, or assistance to the Contractor or any subcontractor in support of the preparation or submission of the Contractor’s business or technical proposal. The report shall include the following information:

a. The name, title, and contact information for the consultant, including the name and contact information for his/her company/firm/etc.

b. The name, title, and contact information for a Contractor point of contact, including the name and contact information for the prime contractor if the consulting services were received by a subcontractor.

c. The nature of the consulting services received.

c. Resolution: The responsible Contracting Officer will review the Contractor’s disclosure to determine whether an actual or appearance of a conflict of interest exists based on the information disclosed by the Contractor and/or from other sources. The framework for the Contracting Officer’s review will be FAR Subpart 9.5, Organizational and Consultant Conflicts of Interest. If an actual or appearance of a conflict of interest exists, the Contracting officer will take action which may include, but is not limited to, requesting a mitigation plan from the Contractor.

B.7. 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;

• Travel Costs: Provide a breakout of travel costs for each year including the purpose and number of trips, origin and destination(s), duration and travelers per trip.

h) Costs incurred in the performance of any cost-reimbursement type subcontract (including consulting agreements);

i) Costs to be paid for the performance of a fixed-price subcontract that exceeds $250,000.00;

j) Refreshments and Meal Expenditures;

k) Promotional Items

l) Printing

SECTION C – STATEMENT OF WORK

C.1 BACKGROUND

The potential for a human pandemic resulting from an emerging infectious disease continues to be a public health concern. The threat of a human influenza pandemic has greatly increased over the past several years with the emergence of highly virulent avian influenza viruses like H5N1 and H7N9 viruses. Four influenza pandemics (1918, 1957, 1968 and 2009) occurred over the last century, and an unprecedented number of human infections with avian influenza A (H7N9) in the fifth epidemic wave during the winter of 2016-2017 in China and their antigenic divergence from the viruses that emerged in 2013 have shown that influenza viruses are unpredictable – we can never be certain of when or from where the next pandemic will arise. However, another influenza pandemic is inevitable in this interconnected world, and the question is not if we will have another pandemic, but when. Furthermore, we are in the midst of the COVID-19 pandemic with high mortality and infectivity around the world. The COVID-19 pandemic has underscored the importance of US preparation for outbreaks of respiratory and other infectious diseases.

The National Strategy for Pandemic Influenza (November 2005) describes the national approach to prepare, detect, and respond to pandemic influenza and defines the responsibilities of the federal government and others. The strategy seeks to “establish domestic production capacity and a stockpile of countermeasures to ensure sufficient vaccine to vaccinate front-line personnel and at-risk populations”. Since 2005, several policy documents from US government agencies have established a preparedness goal of maintaining enough pre-pandemic antigen and adjuvants to rapidly formulate vaccine from the National Pre-pandemic Influenza Vaccine Stockpile (NPIVS) to vaccinate 26 million persons as well as to expand the domestic vaccine manufacturing capacity to produce enough vaccine for the entire US population within 6 months of a pandemic declaration. The HHS Pandemic Influenza Plan was updated in 2017 to establish delivery of first doses of pandemic vaccine within 12 weeks of a pandemic declaration. (U.S. Homeland Security Council. National Strategy for Pandemic Influenza. Available from:https://www.cdc.gov/flu/pandemic-resources/pdf/pandemic-influenza-strategy- 2005.pdf. (November 2005). U.S. Homeland Security Council. National Strategy for Pandemic Influenza Implementation Plan. Available from: https://www.cdc.gov/flu/pandemic-resources/pdf/pandemic-influenza-implementation.pdf. (May 2006). Centers for Disease Control and Prevention, U.S. Department of Health and Human Services. Interim Updated Planning Guidance on Allocating and Targeting Pandemic Influenza Vaccine During an Influenza Pandemic. Available from: https://www.cdc.gov/flu/pandemic-resources/national-strategy/index.html. (2018). U.S. Department of Health and Human Services. Pandemic Influenza Plan 2017 Update. Available from: https://www.cdc.gov/flu/pandemic-resources/pdf/pan-flu-report-2017v2.pdf. (2017)).

BARDA's National Pre-pandemic Influenza Vaccine Stockpile (NPIVS) Program provides preparedness for influenza pandemics and maintains stockpiles of influenza vaccine antigens and adjuvants. The Program utilizes the HHS Influenza Risk Assessment Tool to identify and evaluate potential pandemic influenza virus threats.

https://www.cdc.gov/flu/pandemic-resources/pdf/pandemic-influenza-strategy-2005.pdf https://www.cdc.gov/flu/pandemic-resources/pdf/pandemic-influenza-strategy-2005.pdf https://www.cdc.gov/flu/pandemic-resources/pdf/pandemic-influenza-implementation.pdf https://www.cdc.gov/flu/pandemic-resources/pdf/pandemic-influenza-implementation.pdf https://www.cdc.gov/flu/pandemic-resources/national-strategy/index.html https://www.cdc.gov/flu/pandemic-resources/national-strategy/index.html https://www.cdc.gov/flu/pandemic-resources/pdf/pan-flu-report-2017v2.pdf

Informed by these results, BARDA implements measured responses from development of candidate vaccine viruses, virus 'seeds', clinical investigational lot production, clinical safety and immunogenicity trials, to commercial scale vaccine manufacturing for stockpiling. The quality of stockpiled vaccines is routinely evaluated through vaccine potency assays as part of master stability programs at the vaccine manufacturers that store the stockpiled vaccines, and laboratory assays that measure the cross-reactivity of sera from animals and humans immunized with the stockpiled vaccines against previous and circulating influenza viruses with pandemic potential. Clinical studies started in 2015 to evaluate the immunity afforded by old and new stockpiled vaccines as well as to understand the antigenic space that vaccination with heterologous influenza virus strains may induce during the immune response. The results from all of these studies continuously shape the NPIVS so that it continues to provide efficient and broadly effective protection against a potential influenza pandemic.

BARDA maintains the NPIVS inventory through public-private partnerships with domestic influenza vaccine manufacturers using egg- and cell-based vaccine and oil-in-water adjuvant technologies. BARDA-industry partnerships proved vital during the 2009 H1N1 Pandemic when H1N1 monovalent vaccine was made available to meet U.S. demand. Together with its partners, BARDA has stockpiled hundreds of millions of doses of pre-pandemic H5N1 bulk vaccine covering several virus variants since 2005, and tens of millions of doses of H7N9 vaccine since 2013. BARDA also maintains a library of vaccine virus production 'seeds' to address lower-risk pre-pandemic threats. BARDA's NPIVS Program will continue to sustain and expand the dynamic pre-pandemic influenza vaccine stockpile using modern vaccine technologies and stay ready for pandemic responses with vaccine manufacturers and the capabilities of BARDA's Centers for Innovation in Advanced Development and Manufacturing.

The 2009 H1N1 influenza pandemic and the 2019 COVID-19 pandemic demonstrated how crucial it is to have active contracts with manufacturers to respond to a pandemic event. In 2009 the US 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 several influenza vaccine experienced companies. The competition will be open to companies that have licensed influenza vaccine (seasonal or pandemic). In addition, competition is open to Offerors that demonstrate a successful experience in the manufacturing of influenza vaccines at commercial scale, and have submitted a Biologics License Application (BLA) for seasonal or pandemic influenza vaccine, and finally, Contractors with a licensed influenza vaccine may respond with a proposal for manufacturing of vaccines or adjuvants for use in responding to an emerging pathogen during a Public Health Emergency (PHE).

C.2 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 (US facilities preferred) not otherwise provided by the USG as needed to perform the work described below.

The Contractor shall:

1) Provide Medical Countermeasures (MCMs), such as vaccines and adjuvants, for Pandemic

Preparedness and Response or as required in response to a HHS designated Public Health Emergency.

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

3) Produce vaccines and/or adjuvants to support USG efforts to modernize influenza virus vaccines (for which feasibility data is available). Examples may include the reduction in time from viral sequence identification of an influenza virus strain of interest to availability of first doses of vaccine, expanded vaccine delivery options, and/or other approaches to produce and deliver more vaccine doses in less time https://www.medicalcountermeasures.gov/glossary.aspx#BARDA https://www.medicalcountermeasures.gov/glossary.aspx#BARDA https://www.medicalcountermeasures.gov/glossary.aspx#BARDA https://www.medicalcountermeasures.gov/glossary.aspx#BARDA https://www.medicalcountermeasures.gov/glossary.aspx#BARDA https://www.medicalcountermeasures.gov/glossary.aspx#BARDA https://www.medicalcountermeasures.gov/glossary.aspx#BARDA

4) For influenza, Contractor must demonstrate successful experience in the manufacturing of influenza vaccine by:

• Hold a US influenza virus vaccine license

OR

• Have Developed an influenza vaccine as evidenced by

- Submission of a BLA to the US FDA for seasonal or pandemic influenza virus vaccine

C.2.1. 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 submitted BLA, 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.

• Provide seed lot samples to the FDA for identity verification, and perform 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.

• 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 SOW

• Provide data derived from the manufacturing process.

• 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 submitted BLA.

• Perform and provide to HHS lot release product testing of the influenza vaccine using lot release specifications of the FDA-licensed influenza vaccine product. Provide lot release documents in the final report.

• Make batch records available for review by HHS.

• Set aside samples for stability testing for at least 120 months.

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

• Submit standard data report 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 submitted BLA.

• Perform and provide to HHS lot release product testing of the influenza vaccine including potency using lot release specifications of the FDA-licensed influenza vaccine Set aside samples for stability study testing for at least 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 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 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 fill-finishing for use in the clinic, including clinical trial or use during a public health emergency. Proposed adjuvant shall have completed Phase 2 development in combination with a pandemic influenza or pre-pandemic influenza or emerging pathogen antigen. Clinical evidence of antigen sparing and/or adjuvant benefit for the pandemic influenza or pre-pandemic influenza or emerging pathogen antigen is required.

The Contractor shall:

• 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 at least 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.

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

CLIN 0006: Formulation and Filling The unit for this item is each (vial, syringe and sprayer) The contractor shall:

• Formulate and fill 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 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.

• 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. In the event of a public health emergency, HHS may require different container labeling criteria for distribution and administration to the US population.

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

• Set aside final containers for stability study testing for at least 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 according to instructions in ‘Reporting Requirements.’ Provide a final report including, at minimum, the information identified in the Final Report Requirements Table 1.

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 at least 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 a comprehensive 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.

This includes use of drug product in the clinic.

• 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 report according to instructions in ‘Reporting Requirements.’ Provide a final report including, at minimum, the information identified in the Final Report Requirements Table 1.

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

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

CLIN 0008: Shipping The unit for this item is each The Contractor shall:

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

• Arrange for transit, delivery and insurance of material shipped. Send EDI 856 Advanced Shipping Notices upon request. Send Safety Data Sheet(s) and HDA Standard Rx Product Information Form(s) if requested.

• 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 according to instructions in ‘Reporting Requirements.’

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

• Complete BARDA Request For Shipment to Clinical Study Sites

CLIN 0009: Candidate Vaccine Virus (CVV)

• Prepare non-GLP and/or GLP influenza candidate vaccine viruses as directed by HHS and specified in the SOW of the Task Order

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

CLIN 0010: Potency reagent and standards manufacture and testing The Contractor shall provide influenza vaccine reagents and standards.

• 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 SOW, develop and produce influenza vaccine reagents and standards for other reagent process (HPLC, Mass Spec and others)

CLIN 0011: Analytical Laboratory Testing/Assay The contractor shall:

• Conduct laboratory testing/assay as required by HHS and specified in the SOW of the Task Order

• Provide costs for testing as described in the Technical/Business Proposal Instruction for CLIN 0011.

CLIN 0012: Non-Clinical Studies

• Conduct non-clinical studies as required by HHS and specified in the SOW of the Task Order

CLIN 0013: Clinical Studies

• Conduct Clinical studies as required by HHS and specified in the SOW of the Task Order

• 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 SOW.

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

CLIN 0014: Disposal of product The unit for this item is each (any unit of issue identified in SOW)

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

The Contractor shall:

• Dispose of product following all federal and state regulations for the appropriate waste category;

hazardous waste (e.g. thimerosal-containing vaccines), regulated medical waste (e.g. LAIV), solid waste (e.g. non thimerosal-containing vaccine, non LAIV).

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

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

CLIN 0015: Standard Data Reporting Requirements The Contractor shall submit detailed data regarding project materials, sources, and manufacturing sites, including but not limited to: physical locations of sources of raw and processed material by type of material; location and nature of work performed at manufacturing, processing, and fill/finish sites; and location and nature of non-clinical and clinical studies sites. In the event of a Public Health Emergency, HHS may require daily reporting of manufacturing campaigns during response operations. BARDA may provide a table in tabular format for Contractor to be used to submit such data which would include but not be limited to the following:

• Manufacturing locations

• Seed development or other starting material manufacturing

• Critical materials

• Manufacturing production projections

• Bulk drug substance and/or adjuvant production

• Fill, finish, and release of product or adjuvant

• Storage/inventory of starting materials, bulk substance, or filled/final product or adjuvant

• Stability information of bulk substance and/or finished product

• Shipment of bulk substance or final finished product

• Disposal of bulk substance or final product

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.

• Respond to request of information from HHS pertaining to activities related to Task orders

• 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 and 24 hours for a security activity or incident. An impact assessment and remediation plan shall be provided within five (5) business days of the incident.

• 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 at least 120 months from the date of manufacture. If insufficient samples, resample bulk lots of antigen or adjuvant to continue stability program

• 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 a comprehensive inventory (lot number, number of lots, number of vials), including inventory quantity changes, current quantity, storage facility/location,…