11-100-SOL-00020.pdf

DEPARTMENT OF HEALTH & HUMAN SERVICES Office of the Secretary

Office of the Assistant Secretary for Preparedness & Response Washington, D.C. 20201

FROM: Mekeba Brown Barrett

Contract Specialist Acquisition Management, Contracts and Grants

TO: Prospective Offerors

RE: Request for Proposal (RFP) Number 11-100-SOL-00020 “Acquisition of MCMs for Pandemic Influenza Preparedness and Response”

DATE: Monday, February 27, 2012

This RFP represents the Department of Health and Human Services (HHS) effort to

This RFP includes Mandatory Criteria for Eligibility. Please refer to Section M, for specific details regarding the mandatory criteria.

Questions concerning this RFP must be submitted in writing to Mekeba Barrett, no later than Friday, March 9, 2012 via E-mail at mekeba.barrett@hhs.gov. Questions should be submitted with the subject “Questions Regarding RFP 11-100-SOL-00020.” All questions and answers will be made available via the Federal Business Opportunities Website (www.fedbizopps.gov).

In accordance with the attached RFP, Offerors are required to submit their proposals to the Contracting Officer no later than Friday, April 13, 2012 by 11:00 AM Eastern Time.

Letters of intent to submit a proposal must be received by Friday, March 23, 2012. The Proposal Intent Response Sheet is Attachment 2 of this RFP. Please note that your expression of intent to submit a proposal is not binding but greatly assists HHS in planning for the proposal evaluation process. Past Performance Questionnaires, as mentioned in Section M, must be received by the Contract Specialist by Friday, April 13, 2012.

Prospective Offerors are advised that HHS is operating under stringent security requirements applied to all incoming mail and packages. This includes all proposals submitted under HHS solicitations by regular mail, express/overnight mail delivery or hand delivered directly by an Offeror or by a courier service. Please note that personal identification of couriers or Offerors is required for delivery of proposals. Please see Attachment 1, in addition to the RFP, for packaging and delivery of proposal instructions.

Thank you for your interest in doing business with the Federal Government.

mailto:mekeba.barrett@hhs.gov� http://www.fedbizopps.gov/�

RFP No. 11-100-SOL-00020 - Acquisition of MCMs for Pandemic Influenza Preparedness and Response

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 61

2. CONTRACT NO.

3. SOLICITATION NO.

11-100-SOL-00020

4. TYPE OF SOLICITATION

SEALED BID (IFB)

X NEGOTIATED (RFP)

5. DATE ISSUED

02/27/2012

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 SEE SECTION L handcarried, in the depository located in copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8 , or if SEE ATTACHMENT 1 until 11:00AM local time

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.

04/13/2012

10. FOR INFORMATION

CALL:

A. NAME

Mekeba Barrett

B. TELEPHONE (NO COLLECT CALLS)

(202) 260-1591

C. E-MAIL ADDRESS

mekeba.barrett@hhs.gov

11. TABLE OF CONTENTS

(x) DESCRIPTION (x) DESCRIPTION

PART I – THE SCHEDULE PART II – CONTRACT CLAUSES

X A SOLICITATION/CONTRACT FORM 1 X I CONTRACT CLAUSES 27 - 31

X B SUPPLIES OR SERVICES AND PRICES/COSTS 2 - 5 PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

X C DESCRIPTION/SPECS./WORK STATEMENT 6 - 13 X J LIST OF ATTACHMENTS 32

X D PACKAGING AND MARKING 14 PART IV – REPRESENTATIONS AND INSTRUCTIONS

X E INSPECTION AND ACCEPTANCE 15 REPRESENTATIONS, CERTIFICATIONS, AND 33

X F DELIVERIES OR PERFORMANCE 16 - 17 X K OTHER STATEMENTS OF OFFERORS

X G CONTRACT ADMINISTRATION DATA 18 - 19 X L INSTRS., CONDS., AND NOTICES TO OFFERORS 34 - 48

X H SPECIAL CONTRACT REQUIREMENTS 20 - 26 X M EVALUATION FACTORS FOR AWARD 49 - 52

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 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 calendar days (60 calendar days unless a different 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. 11-100-SOL-00020 - Acquisition of MCMs for Pandemic Influenza Preparedness and Response 2

SECTION B--SUPPLIES OR SERVICES AND PRICES/COSTS

B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The goal of this solicitation is the development and acquisition of Medical Countermeasures (MCMs) for Pandemic Influenza Preparedness and Response. The following specific objectives highlight a comprehensive strategy and commitment by HHS to provide MCMs against pandemic influenza and influenza strains with pandemic potential: Master and working virus seed for production of influenza pre-pandemic and pandemic vaccine product; influenza pre-pandemic and pandemic vaccine production at pilot, clinical and commercial scale; adjuvant production at commercial scale; vaccine and adjuvant storage and stability programs;

formulation, fill, finish of pre-pandemic, pandemic influenza vaccine and adjuvant; international and domestic shipping of vaccine, disposal of vaccine bulk and final container, non-clinical and clinical studies using pre-pandemic and pandemic influenza vaccine;

storage services and stability program for vaccine and adjuvants, (bulk and final containers) from current contracts, when applicable.

B.2. CONTRACT LINE ITEM NUMBERS (CLINs)

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.

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

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. Contractors shall provide the following items for the manufacturing, testing, packaging, delivery, storage and disposal of influenza MCM products. Items shall be provided according to US licensed influenza vaccine or non-licensed products as applicable:

BASE PERIOD: (Contract Award through thirty six (36) Months)

ITEM ITEM NAME UNIT MAXIMUM

QUANTITY UNIT PRICE TOTAL EXTENDED

PRICE

cGMP Influenza Vaccine Master and Working Seed Lot

LOT 15

0002 Non-GMP Influenza Vaccine: Pilot Lot(s) LOT 15

0003 cGMP Influenza Vaccine:

Clinical Lot (s) LOT 15

0004 cGMP Influenza Vaccine:

Bulk Lot(s) LOT 750

0005 cGMP Adjuvant: Bulk Lot(s) LOT 25

0006 Storage of Bulk Lot(s) of Vaccine and/or Adjuvant LOT 50

0007A Storage of Bulk Lots of Vaccine from Prior Contracts

LOT 285

0007B Storage of Bulk Lots of Adjuvant from Prior Contracts

LOT 390

0008 Formulation of Vaccine - Fill single dose vials SDV 200,000

0009 Formulation of vaccine - Fill syringes or sprayers PFS/S 100,000,000

0010 Formulation of vaccine - Fill multi-dose vials MDV 10,000,000

Formulation of vaccine and adjuvant - Fill syringes

PFS/S 100,000,000

0012 Formulation of vaccine and adjuvant - Fill multi- MDV 10,000,000

RFP No. 11-100-SOL-00020 - Acquisition of MCMs for Pandemic Influenza Preparedness and Response 3 dose vials

Storage and Stability in Final Containers of CLINS 0008-0012

MDV or PFS/S 5,000,000

0014A Domestic Shipping of

CLINS 0008-0012 PALLETS 100

0014B International Shipping of

CLINS 0008-0012 PALLETS 100

Disposal of CLINS 0001 – 0005, 0007A, 0007B& 0008 - 0012

PALLETS 25

0016 Influenza Vaccine and/or Adjuvant Animal Test STUDY 25

Influenza Vaccine and/or Adjuvant Clinical Immunogenicity Test

STUDY 5 studies with 150 people each

0018 Additional Reporting and Inventory Requirements Report Not separately priced

GRAND TOTAL (BASE PERIOD): $________________________________________

OPTION PERIOD I: (August xx, 2015 through August xx, 2016)

PRICE

cGMP Influenza Vaccine Master and Working Seed Lot

LOT 15

0002 Non-GMP Influenza Vaccine: Pilot Lot(s) LOT 15

0003 cGMP Influenza Vaccine:

Clinical Lot (s) LOT 15

0004 cGMP Influenza Vaccine:

Bulk Lot(s) LOT 750

0005 cGMP Adjuvant: Bulk Lot(s) LOT 25

0006 Storage of Bulk Lot(s) of Vaccine and/or Adjuvant LOT 50

0007A Storage of Bulk Lots of Vaccine from Prior Contracts

LOT 285

0007B Storage of Bulk Lots of Adjuvant from Prior Contracts

LOT 390

0008 Formulation of Vaccine - Fill single dose vials SDV 200,000

0009 Formulation of vaccine - Fill syringes or sprayers PFS/S 100,000,000

0010 Formulation of vaccine - Fill multi-dose vials MDV 10,000,000

Formulation of vaccine and adjuvant - Fill syringes

PFS/S 100,000,000

Formulation of vaccine and adjuvant - Fill multi-dose vials

MDV 10,000,000

0013 Storage and Stability in Final Containers of CLINS MDV or PFS/S 5,000,000

RFP No. 11-100-SOL-00020 - Acquisition of MCMs for Pandemic Influenza Preparedness and Response 4

0008-0012

0014A Domestic Shipping of

CLINS 0008-0012 PALLETS 100

0014B International Shipping of

CLINS 0008-0012 PALLETS 100

Disposal of CLINS 0001 – 0005, 0007A, 0007B& 0008 - 0012

PALLETS 25

0016 Influenza Vaccine and/or Adjuvant Animal Test STUDY 25

Influenza Vaccine and/or Adjuvant Clinical Immunogenicity Test

STUDY 5 studies with 150 people each

GRAND TOTAL (OPTION PERIOD I): $________________________________________

OPTION PERIOD II: (August xx, 2016 through August xx, 2017)

PRICE

cGMP Influenza Vaccine Master and Working Seed Lot

LOT 15

0002 Non-GMP Influenza Vaccine: Pilot Lot(s) LOT 15

0003 cGMP Influenza Vaccine:

Clinical Lot (s) LOT 15

0004 cGMP Influenza Vaccine:

Bulk Lot(s) LOT 750

0005 cGMP Adjuvant: Bulk Lot(s) LOT 25

0006 Storage of Bulk Lot(s) of Vaccine and/or Adjuvant LOT 50

0007A Storage of Bulk Lots of Vaccine from Prior Contracts

LOT 285

0007B Storage of Bulk Lots of Adjuvant from Prior Contracts

LOT 390

0008 Formulation of Vaccine - Fill single dose vials SDV 200,000

0009 Formulation of vaccine - Fill syringes or sprayers PFS/S 100,000,000

0010 Formulation of vaccine - Fill multi-dose vials MDV 10,000,000

Formulation of vaccine and adjuvant - Fill syringes

PFS/S 100,000,000

Formulation of vaccine and adjuvant - Fill multi-dose vials

MDV 10,000,000

Storage and Stability in Final Containers of CLINS 0008-0012

MDV or PFS/S 5,000,000

0014A Domestic Shipping of PALLETS 100

RFP No. 11-100-SOL-00020 - Acquisition of MCMs for Pandemic Influenza Preparedness and Response 5

CLINS 0008-0012

0014B International Shipping of

CLINS 0008-0012 PALLETS 100

Disposal of CLINS 0001 – 0005, 0007A, 0007B& 0008 - 0012

PALLETS 25

0016 Influenza Vaccine and/or Adjuvant Animal Test STUDY 25

Influenza Vaccine and/or Adjuvant Clinical Immunogenicity Test

STUDY 5 studies with 150 people each

GRAND TOTAL (OPTION PERIOD II): $________________________________________

TOTAL CONTRACT VALUE (BASE AND ALL OPTION PERIODS): $________________________________________

B.3. CONTRACT TYPE

This is an indefinite-delivery, indefinite-quantity (IDIQ) contract for the acquisition of MCMs for pandemic Influenza preparedness and response. 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 prices listed above.

1. Delivery Order and Task Order Type

Delivery orders and task orders issued under this contract will be firm-fixed price. Ordering instructions can be found in Section H.18.

2. Minimum and Maximum Quantity

The minimum ordering limitation and Government guarantee under this contract is one (1) lot of CLIN 0001 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:

Invoicing for these CLINS shall be done at a minimum on a quarterly basis and no greater than on a monthly basis.

The offeror will be responsible for maintaining Government Property (GP) in accordance with FAR 52.245-1. The products purchased, shipped and stored under this contract are considered GP and should be appropriately stored, labeled and inventoried. As defined in FAR 45.101 and 52.245.-1 ,“Contractor-acquired property” means property acquired, fabricated, or otherwise provided by the contractor for performing a contract and to which the Government has title.

“Government property” means all property owned or leased by the Government. Government property includes both Government-furnished property and contractor-acquired property. Government property includes material, equipment, special tooling, special test equipment, and real property. Government property does not include intellectual property and software.

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 0001 up to the minimum guaranteed amount. Additional quantities may be ordered upon the Government’s need and contractor’s ability to produce the requirement. The Government reserves the right to make multiple awards.

RFP No. 11-100-SOL-00020 - Acquisition of MCMs for Pandemic Influenza Preparedness and Response 6

SECTION C – STATEMENT OF WORK

C.1. STATEMENT OF WORK

Background

Human influenza pandemics continue to be a public health concern. Four human influenza pandemics have occurred in the past century. We have recently completed the preparation and response to the 2009 H1N1 pandemic influenza virus which fortunately produced only mild illness and had low transmissibility. The mortality of a future severe influenza pandemic has been estimated at over 60 million deaths worldwide. At this time it is uncertain which influenza virus variant will cause the next pandemic.

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 are 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 expanded 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 Sibelius 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.”

The 2009 H1N1 influenza pandemic demonstrated the criticality of having active contracts with manufacturers to respond to an influenza pandemic event; in 2009 the Federal Government rapidly modified the existing stockpile contracts and issued task orders to manufacturers for producing millions of doses of H1N1 influenza vaccine.

The competition will be open to companies that currently produce inactivated, recombinant and LAIV, seasonal, pre-pandemic and pandemic influenza vaccine at commercial scale. The Offeror needs to demonstrate a successful experience in the manufacturing of influenza vaccines at commercial scale, have completed (final Clinical Study Report) Phase 3 clinical studies for influenza vaccines and have a documented BLA in preparation for an influenza vaccine.

The Contractor shall provide the following items and/or services:

Master and working virus seed for production of influenza pre-pandemic and pandemic vaccine product; production at small scale, clinical and commercial scale influenza pre-pandemic and pandemic vaccine; adjuvant production at commercial scale; vaccine and adjuvant storage and stability studies; formulation, fill, finish of pre-pandemic, pandemic influenza vaccine and adjuvant; international and domestic shipping of vaccine, disposal of vaccine bulk and final container; non-clinical and clinical studies using pre-pandemic and pandemic influenza vaccine; storage services and stability program for vaccine and adjuvants, (bulk and final containers) from current expiring contracts. Contractors without adjuvant programs will not be required to provide.CLIN 0005, 0007B.

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.

RFP No. 11-100-SOL-00020 - Acquisition of MCMs for Pandemic Influenza Preparedness and Response 7

The Contractor shall provide Medical Countermeasures (MCMs) for Pandemic Influenza Preparedness and Response or as required in response to a HHS designated Public Health Emergency. The contractor shall produce vaccines against influenza and influenza strains with pandemic potential; shall demonstrate a successful experience in the manufacturing of influenza vaccine by:

• Holding a US influenza vaccine license OR Have developed an influenza vaccine as evidenced by a final clinical study report from a Phase 3 clinical study conducted under a FDA Investigational New Drug application sponsored by the Offeror..

Summary of CLINs It is mandatory for offerors to respond to all CLINs, except 0005. As directed by HHS, the Contractor shall provide inactivated, live attenuated or recombinant technology produced vaccine bulk product for influenza viruses as follows:

• Master and working virus seeds for production of influenza vaccine product;

CLIN 0001: cGMP Influenza Vaccine Master and Working Seed Lot

• Small scale pilot, clinical and commercial lots of vaccines and/or adjuvants;

CLIN 0002: Non-GMP Influenza Vaccine: Pilot Lot(s) CLIN 0003: cGMP Influenza Vaccine: Clinical Lot (s) CLIN 0004: cGMP Influenza Vaccine: Bulk Lot(s) CLIN 0005: cGMP Adjuvant: Bulk Lot(s)

• Storage and Stability of Bulk Product from these CLINs and prior contracts.

CLIN 0006: Storage of Bulk Lot(s) of Vaccine and/or Adjuvant CLIN 0007A and 0007B: Storage of Bulk Lots of Vaccine and/or Adjuvant from Prior Contracts

• Formulation, filling and packaging in a variety of final containers (nasal-sprayers, multi-dose vials, syringes, non-adjuvanted and adjuvanted formulations).

CLINs 0008-0012: Formulation and Filling of Influenza Vaccine and/or Adjuvant in a Variety of

Final Containers.

• Storage and stability of product in the final container.

CLIN 0013: Storage and Stability in Final Containers of CLINS 0008-0012

• International shipping of bulk vaccine and adjuvant and final container.

CLIN 0014A and CLIN 0014B: International and Domestic Shipping of CLINS 0008-0012

• Disposal of bulk vaccine, adjuvant and final container

CLIN 0015: Disposal

• Pre-clinical and clinical evaluation of products.

CLIN 0016: Influenza Vaccine Animal Test CLIN 0017: Influenza Vaccine Clinical Test

• Reporting and inventory CLIN 0018: Reporting and Inventory Requirements

C.2. Detailed Description of CLINs:

CLIN 0001: cGMP Influenza Vaccine Optimized Master and Working Seed Lot Under Item 0001, the Contractor shall provide optimized master and working seed lots for inactivated, live attenuated or recombinant influenza vaccine product suitable for efficient commercial scale manufacturing of vaccine. The seeds lots for influenza vaccine product shall be manufactured using the same facilities, systems, equipment, processes and testing as those used for the FDA-licensed influenza vaccine or as described in the BLA in preparation. The influenza vaccine seed lot shall be produced using a qualified virus reference strain as designated by HHS.

The Contractor shall, as specified in the note above:

• Manufacture the seed lot from the influenza virus vaccine candidate specified by HHS. Manufacture the seed lot at commercial scale in commercial manufacturing facilities described and referenced for this activity in the FDA license or in-process BLA according to current Good Manufacturing Practices (cGMP) under 21 CFR parts 210, 211, and 600, as applicable, and store at appropriate conditions.

• Use a validated, commercial-scale production process for influenza vaccine to manufacture the seed lots.

Where applicable use processes detailed in the licensed vaccine manufacture. For un-licensed vaccine products, use processes described in the in-process BLA.

• Provide lot release product testing of the influenza seed lot (using lot release specifications similar to those of the FDA-licensed influenza product, or the in-process BLA filing). Submit seed samples to the FDA for testing and approval for use in vaccine production.

RFP No. 11-100-SOL-00020 - Acquisition of MCMs for Pandemic Influenza Preparedness and Response 8

• Store seed lots according to FDA cGMP guidelines.

CLIN 0002: Non-GMP Influenza Vaccine: Pilot Lot(s) Under Item 0002, the Contractor shall provide an influenza vaccine non GMP pilot lot.

The Contractor shall:

• The size of the pilot lot will be defined by the Contractor as specified in their proposal.

• Provide all data derived from process yield improvement efforts.

• Make available batch records for review by HHS

• Provide Certificates of Analysis for the manufactured lot.

• Execute a stability program for thirtysix (36) months. Stability testing shall be performed applying FDA cGMP guidelines. Provide the study plan, interim results and final report to HHS.

• Prepare purified influenza immunogen for antisera reagent preparation. Prepare materials for antigen reference standard(s). This activity will be requested by HHS if needed and coordinated with CBER.

CLIN 0003: cGMP Influenza Vaccine: Clinical Lot (s) Under Item 0003, the Contractor shall provide influenza vaccine clinical lot.

The Contractor shall:

• The size of the clinical lot will be defined by the Contractor as specified in their proposal.

• 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 and licensed, or BLA document in preparation, production methods for influenza vaccine manufacture.

• Perform lot release product testing of the influenza vaccine including potency using lot release specifications similar to those 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.

• Provide Certificates of Analysis for the manufactured clinical lots to HHS.

• Provide a master stability program for thirtysix (36) months to HHS. Stability testing shall be performed applying FDA cGMP guidelines and in accordance with the stability requirements that apply to FDA-licensed trivalent influenza vaccine product, if applicable.

• Execute a master stability program for thirtysix (36) months and provide interim and final results to HHS.

• Prepare Prepare purified influenza immunogen for antisera reagent preparation. Prepare materials for antigen reference standard(s). This activity will be requested by HHS if needed and coordinated with CBER.

CLIN 0004: cGMP Influenza Vaccine: Bulk Lot(s) Under Item 0004, the Contractor shall provide influenza vaccine bulk product from viruses with pre-pandemic and pandemic potential suitable for formulation and filling.

The unit for this item will be bulk lot(s) of influenza vaccine product.

The size of a lot will be defined by the manufacturers (number of eggs, bioreactor size in liters, etcetera) as described in their proposal.

The bulk lot of influenza vaccine shall be manufactured, if applicable, using the same facilities, systems, equipment, processes and testing as those used for the FDA-licensed influenza vaccine or the in-process BLA. The influenza vaccine shall be produced using a qualified virus reference strain designated by HHS.

The Contractor shall:

• Manufacture the bulk vaccine product at commercial scale in (FDA-licensed or in-process BLA documented) manufacturing facilities, when such production does not interfere with inter-pandemic influenza vaccine manufacturing, or when required by HHS.

• Manufacture the bulk vaccine product 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 and prior to formulation.

• Use a validated and licensed (or in-process BLA documented) commercial-scale production process for influenza vaccine to manufacture monovalent influenza bulk vaccine.

• Conduct lot release product testing of the influenza bulk vaccine. Provide results to HHS.

RFP No. 11-100-SOL-00020 - Acquisition of MCMs for Pandemic Influenza Preparedness and Response 9

• Make batch records available for review by HHS.

• Provide Certificates of Analysis for the manufactured lots to HHS.

• Provide a master stability program for thirtysix (36) months to HHS. Ensure that sufficient samples are included to extend the stability program up to one-hundred and twenty (120) months.

• Execute stability testing of vaccine complying with FDA cGMP guidelines and in accordance with the stability requirements that apply to FDA-licensed influenza vaccine product, if applicable. Report interim data and results to HHS.

• Prepare purified influenza immunogen for antisera reagent preparation. Prepare materials for antigen reference standard(s). This activity will be requested by HHS if needed and coordinated with CBER.

CLIN 0005: cGMP Adjuvant: Bulk Lot(s) Under Item 0005, the Contractor shall provide an adjuvant bulk product suitable for formulation and filling. The unit for this item will be bulk lot(s) of adjuvant product.

The size of a lot will be defined by the manufacturers (lot size in e.g. liters) as described in their proposal and accepted by the HHS.

The Contractor shall:

• Manufacture the bulk adjuvant product at 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.

• Execute lot release product testing of bulk adjuvant. Provide final report to HHS.

• Make available batch records for review by HHS.

• Provide Certificates of Analysis for the manufactured lots to HHS.

• Provide a master stability program for thirtysix (36) months to HHS. Ensure that sufficient samples are included to extend the stability program up to one-hundred and twenty (120) months.

• Execute stability testing of adjuvant compliant FDA cGMP guidelines. Report interim data and results to HHS.

CLIN 0006: Storage of Bulk Lot(s) of Vaccine and/or Adjuvant Under Item 0006, the Contractor shall provide cGMP controlled storage for all manufactured lots for sixty (60) months at the Contractor site or at a designated facility approved by HHS.

The Contractor shall perform storage using cGMP facilities.

The unit for this item will be storage of bulk lot(s) of vaccine or adjuvant product / month.

The Contractor shall:

• Store vaccine and adjuvant lots in (FDA-licensed) storage facilities. Storage shall be physically segregated from other products and product will be identified as USG property.

• Store vaccine and adjuvant at the Contractor site or at a designated facility approved by HHS applying FDA cGMP guidelines and in accordance with the storage requirements that apply to FDA-licensed influenza vaccine product, if applicable.

• The government reserves the right to review the security system in place and request updates as needed.

• The Contractor is responsible for all costs (including replacement of lost materials) associated with their discretionary movement of the materials storage site.

• The Contractor shall request USG approval of discretionary movement of materials and storage sites.

CLIN 0007A and 0007B: Storage of Bulk Lots of Vaccine and/or Adjuvant from Prior Contracts Under Item 0007A and 0007B, The Contractor shall provide cGMP controlled storage for sixty (60) months at the Contractor site or at a designated facility approved by HHS.

Contractors who receive awards and may be currently storing vaccine or adjuvant. The unit for this item will be storage of lot(s) of vaccine or adjuvant product / month.

The government reserves the right to review the security system in place and request updates as needed.

The Contractor shall:

• Transfer storage of pre-pandemic influenza bulk vaccine and bulk adjuvant produced under previous contracts to the present Item (CLIN 0007A or 0007B) at the expiration of previous contracts.

RFP No. 11-100-SOL-00020 - Acquisition of MCMs for Pandemic Influenza Preparedness and Response 10

• Perform storage using cGMP facilities with equivalent systems, equipment, and processes, as those used for the FDA-licensed product or as documented in the in-process BLA.

• Obtain HHS concurrence on selection of the storage facility.

• Store vaccine and/or adjuvant lots in FDA-licensed storage facilities.

• Storage shall be physically segregated from other products.

• Continue stability testing of stored bulk for sixty (60) months.

CLINs 0008-0012: Formulation and Filling of Influenza Vaccine and/or Adjuvant in a Variety of Final Containers.

When executing CLINS 0008-0012, the contractor shall:

• Perform formulation and filling activities in compliance with FDA cGMP guidelines and license (or in-process BLA documentation).

• Affix labels onto filled final containers with FDA-approved text for a similar product such as licensed influenza vaccine. The label for filled vials shall adhere to BARDA specifications and may include barcodes or radio frequency identification tags on primary containers and/or 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 into FDA approvable containers.

• Execute lot release product testing of the influenza vaccine final container using lot release specifications similar to those of the FDA-license influenza vaccine product. Provide a final report to HHS.

CLIN 0008: Formulate vaccine at the approved concentration designated by the HHS. Fill single dose vials with formulated vaccine product at the volume designated by the HHS. Note the additional requirements of CLINs 0008-0012 above.

CLIN 0009: Formulate vaccine at the approved concentration designated by the HHS. Fill syringes or sprayers with formulated vaccine product at the volume designated by the HHS. Note the additional requirements of CLINs 0008-0012 above.

CLIN 0010: Formulate vaccine at the approved concentration designated by the HHS. Fill multi-dose vials with formulated vaccine product at a volume to be designated by HHS. Note the additional requirements of CLINs 0008-0012 above.

CLIN 0011: Formulate vaccine and adjuvant at the approved concentration designated by HHS. Fill syringes with formulated adjuvanted vaccine product with a volume to be designated by HHS. Note the additional requirements of CLINs 0008-0012 above.

CLIN 0012: Formulate vaccine and adjuvant at the approved concentration designated by HHS. Fill multi-dose vials with formulated adjuvanted vaccine product at a volume designated by HHS. Note the additional requirements of CLINs 0008-0012 above.

CLIN 0013: Storage and Stability in Final Containers of CLINS 0008-0012.

Under Item 0013, the Contractor shall provide cGMP controlled storage and stability program for final containers (CLINs 0008, 0009, 0010, 0011 and 0012) for up to thirtysix (36) months at the Contractor site or at a designated facility approved by HHS.

The unit for this item will be storage of final container(s) of vaccine or adjuvant product / month.

The Contractor shall perform storage using the cGMP facilities, systems, equipment, and processes, as those used for the product release for FDA-licensed influenza vaccine.

The Contractor shall:

• Store the final containers in an FDA approved storage facilities. Storage shall be physically segregated from other products.

• Store final containers up to thirtysix (36) months at the Contractor site or at a designated facility approved by HHS applying FDA cGMP guidelines and in accordance with the storage requirements that apply to FDA-licensed influenza vaccine product.

• The government reserves the right to review the security system in place and request updates as needed.

• The contractor shall define storage density for each product and provide details to HHS for concurrence.

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• Execute stability testing of final containers under this program. Stability testing shall be performed applying FDA cGMP guidelines and in accordance with the stability requirements that apply to ICH guidelines / FDA-licensed influenza vaccine product.

CLIN 0014A: Domestic Shipping of CLINS 0008-0012 Under CLIN 0014, the Contractor will transport final containers under CLINs 0008-0012 to countries designated by HHS.

As noted in Section C.3., CLIN 0014 does not apply to material produced internationally and imported into a US storage facility.

The unit for this item will be pallet(s).

The Contractor shall:

• Package, store, handle and ship CLINs 0008-0012 from their site or temporary storage site to a final destination.

• Include all cost and expenses for transit, delivery and insurance of product.

• Be responsible for delivering material in a condition fit for its intended use (e.g. cold chain handling).

• Address all applicable permitting and regulations.

• Propose costs for shipment of 10 pallets to Chicago

• Propose costs for shipment of 10 pallets to Seattle

• Propose costs for shipment of 10 pallets to Pittsburgh

CLIN 0014B: International Shipping of CLINS 0008-0012 Under CLIN 0014, the Contractor will transport final containers under CLINs 0008-0012 to countries designated by HHS.

As noted in Section C.3., CLIN 0014 does not apply to material produced internationally and imported into a US storage facility.

The unit for this item will be pallet(s).

The Contractor shall:

• Package, store, handle and ship CLINs 0008-0012 from their site or temporary storage site to a final destination.

• Include all cost and expenses for transit, delivery and insurance of product.

• Be responsible for delivering material in a condition fit for its intended use (e.g. cold chain handling).

• Address all applicable import/export permitting and regulations.

• Propose costs for shipment of 10 pallets to Bangladesh

• Propose costs for shipment of 10 pallets to El Salvador

• Propose costs for shipment of 10 pallets to Nigeria

CLIN 0015: Disposal Under CLIN 15, the Contractor will dispose of all products from CLINs 0001-0005, 0007 (A & B), and CLINs 0008-0012 as directed by the USG.

The Contractor shall:

• Dispose of product following any federal, state regulation 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

CLIN 0016: Influenza Vaccine and/or Adjuvant Animal Testing Under Item 0016, the Contractor shall perform animal studies using the vaccine and/or adjuvant:

• Animal studies of influenza vaccine and/or adjuvant may be requested to monitor safety,stability and immunogenicity.

• The protocol will be provided by HHS. Studies to be conducted by the Contractor will typically involve the use of 80 mice, divided in 4 groups. Each group will receive vaccine and/or adjuvant at different dosages. Control groups will be included. Alternative animal models will be considered on a case-by-case, scientific merit basis.

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CLIN 0017: Influenza Vaccine and/or Adjuvant Clinical Testing Under Item 0017, the Contractor shall perform clinical studies to assess immunogenicity, safety and/or dose-range of manufactured vaccines and/or adjuvant.

The protocol will be provided by HHS prior to execution of the Delivery Order. For example: A dose ranging study to evaluate the immunogenicity and safety of the influenza vaccine product in adults, elderly or children. Five 60 subject arms, receiving two doses of vaccine and/or adjuvant at concentrations to be determined by HHS, and a placebo/active comparator arm.

CLIN 0018: Additional Reporting and Inventory Requirements Under Item 0018, the Contractor shall submit inventory reports, monthly progress reports, executive summaries, ad hoc reports of urgent developments related to this program and a final report as described in detail in the Reporting requirements and Deliverables. Release protocols and reports shall be also provided to HHS after each manufacturing campaign.

C.3. Additional Requirements The complete Phase 3 clinical study report for a study conducted under a US IND sponsored by the Offeror must be ready for submission to the FDA with no modifications.

It is the preference of HHS that the Contractor manufacture bulk vaccines and bulk adjuvant in the US. Bulk manufacturing facilities shall be in compliance with biosafety level biocontainment procedures. All lots will be evaluated for acceptance by HHS.

When a Contractor manufacturers outside the US, the bulk vaccine, adjuvant and filled containers shall be shipped to the US as soon as the lots are released. Shipment of the vaccine 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 requires testing which should be performed according to applicable federal guidelines (FDA, USDA, CDC and etcetera). The Contractor shall bear all costs for shipping and testing required for import into the US. The Unit process under CLINs 0001-0018 shall not include any costs related to shipping and testing required for import into the US resulting from manufacture outside of the US.

The contractor, using a FDA approved cGMP compliant storage site, shall receive approval by HHS for the location and terms of the storage contract prior to execution of the contract.

Formulation, fill-finish activities of vaccine and adjuvant shall be carried out at facilities in compliance with FDA-cGMP guidelines. Activities described under CLINs 0008 – 0012 shall follow all the requirements of the FDA licensed influenza vaccine product.

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 using the same facilities, systems, equipment, processes and testing as for the licensed product. In lieu of a licensed process, 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 CLINS 0001-0013. Contractors that receive licensure during the course of this contract are required to use the licensed processes for the duration of the contract.

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

In case of a pandemic event, 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.

In case of a pandemic event the contractor must submit a detailed production and delivery schedule for bulk vaccine, bulk adjuvant, final containers within 24 hrs after delivery order is received.

In case of a pandemic event the contractor shall submit a detailed daily report to HHS on all activities on–going under contract and as specifically requested by HHS.

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One year after award, Contractors must prepare a pre-EUA document which shall be reviewed and submitted to HHS for subsequent submission to FDA.

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. 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.

C.4. Reporting Requirements and Deliverables The Contractor(s) shall submit to the Contracting Officer (CO) and the Contracting Officer’s Representative (COR) technical progress reports, executive summaries and stability data covering the work accomplished during each monthly reporting period. On or before the completion date of the contract a Draft Final Report due will be submitted. A final report will be submitted within 30 days after Government comments. Reports shall be submitted electronically via e-mail to the COR, CO and any others they designate. Two hard copies shall be submitted to the CO. Any attachments to the e-mail report shall be submitted in Microsoft Word, Microsoft Excel, Microsoft Project or Microsoft Powerpoint or other file types compatible with the Microsoft Office suite of products. Specialized files can be submitted with prior discussion.

Monthly Technical Progress Reports:

On the fifteenth (15th) of each month the Contractor shall submit a report for the previous calendar month to the COR and the CO. The format and type of Technical Progress Report and Executive Summary will be provided by the COR.

Technical Progress Reports will include baseline and updated project timelines, milestones and summaries of product manufacturing, testing, and clinical evaluation. A Technical Progress Report will not be required for the period when the Final Report is due. The Contractor shall submit one copy of the Technical Progress Report electronically via e-mail to the COR, CO and any others they designate. Such reports shall include the following specific information:

Title page- containing Technical Progress Report, the contract number and title, the period of performance or milestone being reported, the contractor's name, address, and other contact information, the author(s), and the date of submission.

Introduction/Background - An introduction covering the purpose and scope of the contract effort Progress - The report shall detail, document, and summarize the results of work performed, test results, and milestones achieved during the period covered. Also to be included is a summary of work planned for the next reporting period.

Issues - Issues resolved, new issues and outstanding issues are enumerated with options and recommendations for resolution. An explanation of any difference between planned progress and actual progress, why the differences have occurred, and, if project activity is delinquent, then what corrective steps are planned. Revised timelines are provided Invoices – Summary of any invoices submitted during the reporting period Action Items – Summary table of activities or tasks to be accomplished by a certain date and by whom.

Distribution List – A list of persons receiving the Technical Progress report Attachments – Results on the project are provided as attachments

Executive Summary The executive summary shall accompany each Technical Progress Report, will be formatted in Microsoft Power Point presentations and include the following:

Title page containing Executive Title, the contract number and title, the period of performance or milestone being reported, the contractor's name and the date of submission. Project Progress presented as milestone events, test results, tasks, and other activities achieved during the reporting period as talking point bullets. Project Issues presented headings and each item as a talking point bullet.

Final Reports By the expiration date of the contract, the Contractor shall submit a comprehensive Final Report that shall detail, document, and summarize the results of the entire contract work. The report shall explain comprehensively the results achieved. A draft Final Report will be submitted to the COR for review and revision, then the original, four copies, and an electronic file containing the Final Report with revisions shall be submitted to the COR for distribution to the CO and the Program.

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SECTION D – PACKAGING, MARKING AND SHIPPING

D.1. SHIPPING

1. Method of Delivery

Unless otherwise specified by the CO, delivery of items – reports, documents, invoices, etc. not stored by the contractor under this contract, to be furnished to the government under this contract (including invoices), shall be made by United States Postal Service mail delivery, overnight mail delivery or courier service.

2. Addressees – For all contract deliverables

Contracting Officer’s Representative (COR) Contracting officer (CO)

HHS/OS/ASPR/BARDA HHS/OS/ASPR/AMCG

330 Independence Avenue, SW 330 Independence Avenue, SW Room G640 Room G640 Washington, D.C. 20201 Washington, D.C. 20201

D.2. PREPARATION OF VACCINES FOR TRANSPORT

All materials shall be labeled and packaged in accordance with GCP (Good Clinical Practices) and/or GMP (Good Manufacturing Practices) as appropriate. Products shall be packed to ensure compliance with known product stability requirements that maintain satisfactory product temperatures during transit and arrival at destination. Products shall be packed to ensure maintenance of FDA recommended temperature during transit and safe arrival at destination. Freeze Watch Indicators (FWI) or equivalent temperature indicating devices shall be packed in each container containing influenza vaccine. The Contractor is required to maintain records that document the date of delivery receipt, and that the vaccine was properly maintained within the recommended cold chain temperatures during transit and receipt.

Concurrence on planned shipment protocols shall be obtained from HHS prior to transport.

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SECTION E – INSPECTION AND ACCEPTANCE

E.1. INSPECTION AND ACCEPTANCE

The CO or the duly authorized representative (who for purposes of this contract will be the COR) will perform inspection and acceptance of materials and services to be delivered under the contract.

COR Upon receipt and inspection of final lot release data and material, the CO will notify the Contractor of acceptance or rejection. If applicable, a task order for the storage of product shall be issued. Any product produced or stored under this contract shall be subject to inspection by the CO and the COR.

Inspections of material created under this contract may be made by a duly authorized US Government representative, and with reasonable notice (i.e. not less than 24 hours). HHS reserves the right to conduct an audit, either by HHS and/or HHS designee(s), of the facilities used under this contract and all records related to the manufacture, testing and storage of the product.