LVV_FF_RFP_16-100-SOL-00011_4-19-16.pdf

DEPARTMENT OF HEALTH & HUMAN SERVICES Office of the Secretary

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

APRIL 19, 2016

REQUEST FOR PROPOSALS (RFP) No. 16-100-SOL-00011: Respiratory Illness Live Virus Fill / Finish Services

Dear Ladies and Gentlemen:

The Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for

Preparedness and Response (ASPR) at the US Department of Health and Human Services (HHS) through the Office of

Acquisitions Management, Contracts & Grants (AMCG) invites you to submit a proposal in accordance with the requirements of the enclosed RFP No. 16-100-SOL-00011, entitled, “RESPIRATORY ILLNESS LIVE VIRUS FILL / FINISH

SERVICES”

The Government anticipates awarding one or more Indefinite Delivery Indefinite Quantity contract(s) with cost type and firm-fixed price task or delivery orders to meet this requirement. The period of performance will be five (5) years.

The broad purpose of this requirement is to provide filling and finishing capabilities for Live Virus / Vectored Vaccines (LVV) and other type of Medical Countermeasures (MCM) products, as well as augmenting the existing US-based vaccine fill and finish infrastructure surge capacity for Medical Countermeasures, Emerging Infectious Diseases (EID), and other threats of known and unknown origin during a public health emergency.

Offerors are encouraged to read the entire solicitation carefully. Be sure to thoroughly answer all the Technical Evaluation

Criteria in Section M in accordance with the instructions set forth in Section L to include Mandatory Criteria for Eligibility and

Technical Proposal instructions. Additionally, take care to review and comply with the Representations and Certifications in

Section K and the detailed Business Proposal instructions in Section L.

In order to be considered for award, Offerors MUST meet the MANDATORY CRITERIA FOR ELIGIBILITY in Section

M.1.2 and respond to all other requirements of this RFP.

Questions and answers (included as ATTACHMENT No. 12 to this RFP) are provided in response to questions received from the DRAFT RFP No. 16-BARDA-DRAFT-LVV-FF which was posted to Federal Business Opportunities (www.fbo.gov) website in November 2015. BARDA’s answers to the questions posed provide a crosswalk to the pertinent section of this RFP to which the answers relate. While the answers provided by BARDA seek to clarify various matters within the RFP, they do not amend or affect the RFP in any way. This RFP and its amendments are the only official documents that proposals shall be based on.

This solicitation incorporates Federal Acquisition Regulation (FAR) clauses and provisions by reference, which must be fully understood. The full text of these clauses and provisions may be accessed from the following website:

https://www.acquisition.gov/far

HHS must receive your proposal in the contracting office (See Section L) no later than 12:00 PM ET on May 27, 2016.

Sincerely, Office of Acquisitions Management, Contracts & Grants (AMCG)

Matthew A. McCord

Contract Specialist http://www.fbo.gov/ https://www.acquisition.gov/far

16-100-SOL-00011

SOLICITATION, OFFER AND AWARD

4. TYPE OF SOLICITATION2. CONTRACT NUMBER 3. SOLICITATION NUMBER

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

ORDER UNDER DPAS (15 CFR 700)

6. REQUISITION/PURCHASE NUMBER

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

NEGOTIATED (RFP)

SEALED BID (IFB)

5. DATE ISSUED

1. THIS CONTRACT IS A RATED RATING PAGE OF PAGES

1 51

C. E-MAIL ADDRESS

EXT.NUMBERAREA CODE

B. TELEPHONE (NO COLLECT CALLS)A. NAME

10. FOR

INFORMATION

CALL:

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.

(Date)(Hour) local timeuntildepository located in 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

SOLICITATION

9. Sealed offers in original and

PART IV - REPRESENTATIONS AND INSTRUCTIONS

OTHER STATEMENTS OF OFFERORS

EVALUATION FACTORS FOR AWARD

INSTRS., CONDS., AND NOTICES TO OFFERORS

REPRESENTATIONS, CERTIFICATIONS AND

LIST OF ATTACHMENTS

CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

I

J

K

L

M SPECIAL CONTRACT REQUIREMENTS

CONTRACT ADMINISTRATION DATA

DELIVERIES OR PERFORMANCE

INSPECTION AND ACCEPTANCE

PACKAGING AND MARKING

DESCRIPTION/SPECS./WORK STATEMENT

SUPPLIES OR SERVICES AND PRICES/COSTS

SOLICITATION/CONTRACT FORM

PART II - CONTRACT CLAUSESPART I - THE SCHEDULE

H

G

F

E

D

C

B

A

SEC. DESCRIPTION PAGE(S) (X) DESCRIPTION SEC. (X)

11. TABLE OF CONTENTS

18. OFFER DATE17. SIGNATURE

SUCH ADDRESS IN SCHEDULE.

IS DIFFERENT FROM ABOVE - ENTER

15C. CHECK IF REMITTANCE ADDRESS

EXT.NUMBERAREA CODE

15B. TELEPHONE NUMBER

(Type or print)AND

ADDRESS

OF

OFFEROR

CODE FACILITY

16. NAME AND TITLE OF PERSON AUTHORIZED TO SIGN OFFER15A. NAME

DATEAMENDMENT NO.DATEAMENDMENT NO.

and related documents numbered and dated):

amendments to the SOLICITATION for offerors

(The offeror acknowledges receipt of

14. ACKNOWLEDGEMENT OF AMENDMENTS

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

(See Section I, Clause No. 52.232.8)

13. DISCOUNT FOR PROMPT PAYMENT

designated point(s), within the time specified in the schedule.

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

12. In compliance with the above, the undersigned agrees, if this offer is accepted within ______________ calendar days (60 calendar days unless a different period is inserted

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

OFFER (Must be fully completed by offeror)

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

28. AWARD DATE

(Signature of Contracting Officer)

27. UNITED STATES OF AMERICA

25. PAYMENT WILL BE MADE BY

26. NAME OF CONTRACTING OFFICER (Type or print)

CODE 24. ADMINISTERED BY (If other than Item 7)

ITEM

(4 copies unless otherwise specified)

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

41 U.S.C. 253 (c) ( 10 U.S.C. 2304 (c) (

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

21. ACCOUNTING AND APPROPRIATION20. AMOUNT19. ACCEPTED AS TO ITEMS NUMBERED

AWARD (To be completed by government)

CODE

04/14/2016 X

ASPR-BARDA

HHS/OS/ASPR/BARDA

200 C Street, SW Washington DC 20024

SEE SECTION L - INSTRUCTIONS,

CONDITIONS, and NOTICES TO OFFERORS

1200 ET 05/27/2016

MATTHEW A MCCORD 202

MATTHEW.MCCORD@HHS.GOV

260-0689

X

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PAGE(S)

SALIM K. ROBERTS

AUTHORIZED FOR LOCAL REPRODUCTION

Previous edition is unusable

STANDARD FORM 33 (Rev. 9-97)

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

2-5

6-9 13-15 16-21

22-31

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48-51

RFP No. 16-100-SOL-00011

Respiratory Illness Live Virus Fill / Finish Services

RFP No. 16-100-SOL-00011

Respiratory Illness Live Virus Fill / Finish Services

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.

The contract schedule, set forth in Sections B through H, contains contractual information pertinent to this solicitation. It is not an exact representation of the contract document that will be awarded as a result of this solicitation. The contract cost or price and other contractual provisions unique to the Offeror's proposal may be included in the resultant contract.

The contract schedule is intended to provide the Offeror with information to aid in understanding the likely terms and conditions of any resultant contract.

INTENT TO PROPOSE

Please email a non-binding statement as to whether the Offeror intends to submit a proposal under this RFP to

Matthew McCord at matthew.mccord@hhs.gov and Quintin Hackshaw at quintin.hackshaw@hhs.gov by Monday, April 25, 2016 at 4:00 PM ET. Please include the anticipated location for performance of work (City, State, Country). Please note that if your status changes, or you do not learn of this opportunity until after this deadline has passed, you are not precluded from participating in this opportunity. Please just contact the aforesaid parties and alert them immediately.

This statement may be included in the same email message as any questions.

mailto:matthew.mccord@hhs.gov mailto:quintin.hackshaw@hhs.gov

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PART I – THE SCHEDULE

SECTION B – SUPPLIES OR SERVICE AND PRICES / COSTS

B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

This Request for Proposal (RFP) solicits proposals for Indefinite Delivery, Indefinite Quantity (IDIQ) contracts for the execution of filling and finishing services. It is anticipated that fixed price and/or cost type task orders will be issued under this contract.

The Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for

Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS), seeks to establish Medical

Countermeasure Fill / Finish capabilities to facilitate Live/Vectored Virus product Medical Countermeasure (MCM) product development towards licensure. BARDA has a specific need to create core services to support cGMP and non-GMP filling and finishing of a variety of Medical Countermeasure products; small molecule, large molecule, live virus, lyophilized, pre-clinical, clinical, at pilot and commercial scale. BARDA needs Live/Vectored Virus product Medical Countermeasure Fill / Finish core services for BARDA-sponsored product developers and manufacturers that may not have the appropriate or adequate manufacturing facilities or expertise. Additionally, during a public health medical emergency, Medical Countermeasure Fill /

Finish services beyond current Government capacities may be needed to provide finished products rapidly to address the medical emergency. Through a set of contractual agreements, BARDA will establish Fill / Finish Manufacturing capabilities and capacities in order to provide a wide-array of live/vectored virus product services to meet BARDA requirements. BARDA will coordinate the activities as they are awarded under this IDIQ contract.

The Pandemic and All Hazards Preparedness Act (PAHPA) of 2006 established the Biomedical Advanced Research and

Development Authority (BARDA) to support development and acquisition of Medical Countermeasures (MCMs) to prevent or treat the medical consequences of chemical, biological, radiological, and nuclear (CBRN) threats, pandemic influenza (PI), and emerging infectious diseases (EID). These MCMs include vaccines, therapeutics, diagnostics, and medical devices. Additionally, BARDA is entrusted to foster innovation of technologies that enable better manufacturing, testing, and utilization of these medical countermeasures.

As directed by Task Order(s), Contractors shall provide fill and finish services to support the development of live/vectored virus product Medical Countermeasure candidates and/or other MCMs as identified. Once the Contractor is established as a live virus/vectored vaccine fill and finish service provider, other services may be requested via task order. Examples of other products which could potentially be requested are small molecule sterile injectables, large molecule sterile injectables, monoclonal antibodies, pre-clinical, clinical, and FDA approved MCMs. Fill / Finish services can also be requested for rapid response during a public health emergency. Expectations of Fill / Finish services and timelines will be specified in the Task Order (e.g. routine or urgent). Contractors will provide a wide range of fill and finish services, relevant to BARDA’s vision to create a nation with the capability to respond quickly and effectively to natural and emerging threats by providing a range of fill and finish services, which can be used by BARDA and BARDA’s development partners.

B.2. SPECIFIC REQUIREMENTS

Objective 1: Fill / Finish Services: The Contractor shall provide the USG with filling and finishing services to support the development of live/vectored virus product Medical Countermeasure candidates and/or other MCMs as identified.

Objective 2: Rapid MCM Response Readiness: Task Orders may require the development and execution of Fill and Finish services within a predefined / accelerated timeframe.

B.3. CONTRACT TYPE

The Government intends to award one or more Indefinite-Delivery, Indefinite-Quantity (IDIQ) contract(s) for the services identified in the objectives above. During the period of performance of the contract, the Government may order, and the

Contractor shall provide, services as identified in future Task Orders. At the discretion of the Government, Task Orders issued under this contract may be Firm-Fixed Price (FFP); Cost Plus Fixed Fee (CPFF); and/or Cost-Sharing.

Respiratory Illness Live Virus Fill / Finish Services - page 3 of 51 -

B.4. PRICES / COSTS

The final contract will contain the price/cost provisions agreed upon by the Government and the Offeror.

It is anticipated that any contract awarded under this solicitation shall have a period of performance of five years (60 months).

The Government will issue Requests for Task Order Responses (RTORs) and Contractors will compete for Task Orders for live/vectored virus product fill and finish services based on the work described in the Statement of Objectives in SECTION C of this contract. Upon delivery and acceptance of the services described in each Task Order, the Government shall pay to the

Contractor the price, costs or fee set forth in the Task Order.

Below is the possible Contract Line Item Number (CLIN) structure; the final contract will contain CLINs agreed upon by the

Government and the Offeror. Offerors are invited to propose alternate CLINs and sub-CLINs.

B.4.1. Base Period

CLIN

Description of Item(s) and/or

Service(s)

Estimated Cost or Price

(Minimum Guarantee) Not to Exceed (NTE)

Fill and Finish Services on Task Orders $ 100,000.00 $ 100,000,000.00

B.5. ADVANCE UNDERSTANDINGS

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

B.5.1. Minimum Ordering Amount per Contract – $100,000.00

Each potential contract shall be reimbursed by the Government in an amount not less than a total of $100,000.00 for all contract

Task Orders awarded during the base period under this solicitation.

The Government is not obligated to order more than the stated minimum for the base contract period.

B.5.2. Maximum Ordering Amount – $100,000,000.00

The Contractor(s) shall not receive payment from the Government in an amount greater than $100,000,000.00 for successful performance under these contracts, in aggregate.

This contract ceiling represents the upper end of the Government’s likely requirements during the period of performance.

B.5.3. Fulfilling Minimum Order Requirements

The minimum guarantee under this IDIQ contract is $100,000.00 per contract. This amount can only be claimed at the end of the period of performance if the Contractor takes advantages of fair opportunity, as described in FAR 16.505, by proposing on at least one Task Order.

If the Government awards Task Orders to each Contractor in an amount less than $100,000.00 during the contract, the affected

Contractor(s) may invoice for the balance of the guaranteed minimum. This amount can only be claimed at the end of the period of performance if the Contractor takes advantages of fair opportunity, as described in FAR 16.505, by proposing on at least one

Task Order during that period.

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B.5.4. Pricing of Task Orders

Individual Task Orders will be issued as requirements occur and as the need arises, and will specify work to be performed. The

Contractor shall perform all services in accordance with each task order’s work statement/specifications. The terms and conditions set forth in this contract will always apply.

See SECTION G.4. for further ordering information and procedures.

B.5.5. Funding

Funds for requested services provided will be obligated, at the task order level, as task orders are placed, excess funds will be de-obligated at the task order level, by modification to the task order contracts unilaterally by the Government. The Contractor will only be paid for effort that has been authorized by the Government and performed in accordance with the contract specifications, except for the minimum amount guaranteed.

B.5.6. Cost Unallowable Unless Authorized by the Contracting Officer

Notwithstanding the clauses and unless authorized in writing by the Contracting Officer, the cost of the following items or activities shall be unallowable as direct costs:

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) Travel to attend general scientific meetings/conferences;

f) Foreign Travel Costs;

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

h) Costs to be paid for the performance of a fixed-price subcontract that exceeds $150,000.00;

i) Patient Care Costs; and

j) Light Refreshment and Meal Expenditures - Requests to use contract funds to provide light refreshments and/or meals to either federal or nonfederal employees must be submitted to the Contracting Officer’s Representative (COR), with a copy to the Contracting Officer, at least six (6) weeks in advance of the event and are subject to “HHS Policy on

Promoting Efficient Spending: Use of Appropriate Funding for Conferences and Meetings, Food and Promotional Items and Printing and Publications.” The request shall contain the following information: (a) name, date, and location of the event at which the light refreshments and/or meals will be provided; (b) a brief description of the purpose of the event;

(c) a cost breakdown of the estimated light refreshments and/or meals costs; (d) the number of nonfederal and federal attendees receiving light refreshments and/or meals; and (e) if the event will be held at a Government facility.

B.5.7. Invoices - Cost and Personnel Reporting, and Variances from the Negotiated Budget

For contract work performed on a cost reimbursement basis, the Contractor agrees to provide a detailed breakdown on invoices of the following cost categories (as applicable):

1. Direct Labor - Include salaries and wages paid (or accrued) for direct performance of the contract. List individuals by name, title/position, hourly/annual rate, level of effort (actual hours or % of effort), breakdown by task performed by personnel, and amount claimed.

2. Fringe Benefits - Cite rate and amount

3. Overhead - Cite rate and amount

4. Materials & Supplies - Include detailed breakdown when unit price is over $1,000.

5. Travel - Identify travelers, dates, destination, purpose of trip, and amount. Cite COA, if appropriate. List separately, domestic travel, general scientific meeting travel, and foreign travel.

6. Consultant Fees - Identify individuals and amounts.

7. Subcontracts - Attach subcontractor invoice(s).

8. Equipment - Cite authorization and amount.

9. G&A - Cite rate and amount.

10. Total Cost

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11. Fixed Fee

12. Total Cost Plus Fixed Fee (Total CPFF)

For contract work performed on a cost reimbursement basis, monthly invoices must include the cumulative total expenses to date, adjusted (as applicable) to show any amounts suspended by the Government. Also note the Contracting Officer may require the

Contractor to submit detailed support for costs claimed on payment requests. Every cost must be determined to be allocable, reasonable, and allowable per FAR Part 31.

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SECTION C – STATEMENT OF OBJECTIVES (SOO)

C.1. INTRODUCTION/BACKROUND

In the last ten years, the U.S. has experienced the destructive effects of both acts of terrorism and infectious disease outbreaks.

While limited in scope, the anthrax attacks of 2001 were highly disruptive and suggestive of the impact that large-scale acts of bioterrorism would have, if carried out successfully. Similarly, concerns have escalated that terrorist groups might obtain and use chemical, radiological, and nuclear weapons against civilian populations. Events of the last decade – the SARS epidemic of 2003, and the 2014 Ebola epidemic highlight the persistent threats of emerging infectious diseases.

The U.S. Government (USG) has mobilized in many ways to meet such threats. Among the most prominent of these have been the efforts to develop safe and effective MCMs against CBRN threats, pandemic influenza, and emerging infectious diseases. The need for MCMs to diagnose, prevent, mitigate, or treat the illness caused by such agents is clear, but their development has been hindered by the lack of viable markets for such products. The USG has addressed these market barriers by providing substantial support for the research, development, and procurement of MCMs.

This acquisition is part of a comprehensive strategy and commitment in the BARDA Strategic Plan (2011) to establish core service assistance to MCM developers directly in the form of technical, clinical and regulatory assistance, and assist BARDA in addressing public health needs in an emergency. To date, BARDA has provided core service assistance to developers directly in the form of technical, clinical, and regulatory assistance from internal subject matter experts. BARDA core services include the

Centers for Innovation in Advanced Development and Manufacturing (CIADM), Clinical Studies Network (CSN), Nonclinical

Studies Network, and the Fill / Finish Manufacturing Network (FFMN), which have been established by BARDA with industry and Government partners to assist biological product developers with development, clinical studies and manufacturing. The

CIADMs and FFMN were created to rapidly manufacture vaccines and other biological products to address influenza pandemics or emerging infectious disease outbreaks during public health emergencies. BARDA has established the Nonclinical Studies

Network and the Clinical Studies Network to provide CBRN MCM developers with animal model and clinical studies.

BARDA has a specific need to create a Medical Countermeasure core service to support cGMP and non-GMP fill and finish of pre-clinical and clinical live/vectored virus product Medical Countermeasure products at pilot and commercial production scales.

BARDA needs Medical countermeasure Fill / Finish core services because BARDA-sponsored product developers and manufacturers may not have the appropriate or adequate manufacturing facilities or expertise. Additionally, during a public health medical emergency, Medical Countermeasure Fill / Finish services beyond current Government capacities may be needed to provide finished products rapidly to address the medical emergency, as Fill / Finish activities were identified as a bottleneck during past emergencies. Through a set of contractual agreements, BARDA will establish Fill / Finish Manufacturing capabilities and capacities in order to provide a wide-array of live virus/vectored vaccine product services to meet BARDA requirements.

BARDA will coordinate the activities as they are awarded under this IDIQ contract.

The strategic objectives of this acquisition are to:

Provide live/vectored virus product MCM Fill and Finish services for use on a routine or emergency basis by

BARDA and by BARDA’s product development partners

Enhance BARDA’s preparedness and response to CBRN, PI and EID threats.

Provide rapid response capabilities for fill and finish services for a large variety of product(s) and presentation(s) to respond to a public health emergency.

Improve financial management of fill and finish activities and potentially reduce the MCM development costs to

BARDA.

This acquisition provides the manufacturing services and capacity needed for BARDA to establish live/vectored virus product

Medical Countermeasure Fill and Finish Partners. BARDA MCM Programs will identify their fill and finish service needs, and

BARDA will review and prioritize these requests. BARDA intends to issue a task order(s) among the MCM Fill / Finish awardee(s), in accordance with FAR 16 for “Indefinite Delivery – Indefinite Quantity (ID-IQ) contracts.”

Request for Task Order Response (RTOR) proposals from BARDA Fill / Finish partners will be evaluated and awarded in accordance with FAR 16.505.

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C.2. REFERENCES

Pandemic All-Hazard Preparedness Act of 2006 (PL109-417)

Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PL113-5)

BARDA Strategic Plan 2011-2016 (Washington DC: U.S. Department of Health and Human Services Assistant Secretary for

Preparedness and Response, October 14, 2011), http://www.phe.gov/about/barda/Documents/barda-strategic-plan.pdf

ASPR Strategic Plan 2011-2015, accessed February 29, 2012. http://www.phe.gov/about/aspr/strategic-plan

C.3. STATEMENT OF OBJECTIVES (SOO) AND TECHNICAL REQUIREMENTS

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.

C.3.1 Objective I: Fill and Finish Live/Vectored Virus Medical Countermeasures Development

Contractors shall provide technology transfer and fill and finish services of live/vectored virus product and other types of MCM products that include the capability to process clinical investigational lots, engineering lots, process validation lots, and commercial-scale lots. Services may include, but are not limited to: technology transfer, lyophilization development, analytical testing, process optimization, process validation, formulation, filling, labeling, packaging, and distribution.

Services may be provided to support the fill and finish of pharmaceuticals including parenteral drug products, monoclonal antibodies, recombinant proteins, antitoxins, and vaccines. As per the USG requirement, these liquid, lyophilized, or powder drug products may be filled and finished as prefilled syringes or sprayers, cartridges, auto-injectors, single dose or multi-dose vials.

C.3.2 Objective II: Fill and Finish Medical Countermeasures Public Health Emergency Response

Contractors shall augment the existing US-based vaccine fill and finish infrastructure surge capacity for medical countermeasures, emerging infectious diseases, and other threats of known and unknown origin during a public health emergency, as described in

Objective I. Once a public health emergency has been declared, the Contractor shall provide fill and finish services in response to a USG task order. The task order will outline a target timeline for completion of services to address the ongoing public health emergency.

The USG anticipates that there may be other life-saving products being produced for commercial needs at the selected

Contractors’ facilities. The delivery schedule for medical countermeasures will be negotiated between the USG and the

Contractors on a case by case basis to ensure supply of all priority life-saving products is maintained at appropriate levels.

C.4. DELIVERY SCHEDULE

The schedule for delivery of services is set forth below in SECTION F.

http://www.phe.gov/about/aspr/strategic-plan

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C.5. EARNED VALUE MANAGEMENT SYSTEM

The EVMS requirements will be determined at the Task Orders level, and if needed, would be based on the sections below:

C.5.1. Earned Value Management System Plan

Subject to the requirements under FAR Clause52.234-4 , the Contractor shall use principles of Earned Value Management System

(EVMS) in the management of any work ordered under a cost reimbursement Task Order that exceeds the cost thresholds set forth in HHSAR334.201(c ) and (d). The Seven Principles of EVMS are:

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

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

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

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

V. Objectively assess accomplishments at the work performance level.

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

VII. Use Earned Value information in the company’s management processes.

Elements of EVMS shall be applied to all cost reimbursement work under Task Orders that exceed the cost thresholds set forth in

HHSAR 334. 201(c) and (d) as part of the Integrated Master Project Plan. The Contractor shall submit a written summary of the management procedures that it will establish, maintain and use to comply with EVMS requirements when proposing on a qualifying Task Order.

C.5.2. Performance Measurement Baseline Review (PMBR)

The Contractor shall submit a plan for a PMBR to occur within 90 days of the award of a Task Order of sufficient size and cost to require EVMS. At the PMBR, the Contractor and the contracting officer shall mutually agree upon the budget, schedule and technical plan baselines (Performance Measurement Baseline). These baselines shall be the basis for monitoring and reporting progress throughout the life of the contract. The PMBR is conducted to achieve confidence that the baselines accurately capture the entire technical scope of work, are consistent with contract schedule requirements, are reasonably and logically planned, and have adequate resources assigned. The goals of the PMBR are as follows:

1. Jointly assess areas such as the Contractor’s planning for complete coverage of the SOW, logical scheduling of the work activities, adequate resources, and identification of inherent risks

2. Confirm the integrity of the Performance Measurement Baseline (PMB)

3. Foster the use of EVM as a means of communication

4. Provide confidence in the validity of Contractor reporting

5. Identify risks associated with the PMB

6. Present any revised PMBs for approval

7. Present an Integrated Master Schedule: The Contractor shall deliver an initial program level Integrated Master Schedule

(IMS) that rolls up all time-phased WBS elements down to the activity level. This IMS shall include the dependencies that exist between tasks. This IMS will be agreed to and finalized at the PMBR. DI-MGMT-81650 may be referenced as guidance in creation of the IMS (see https://acc.dau.mil/CommunityBrowser.aspx?id=19545)

8. Present the Risk Management Plan. The Contractor shall develop and maintain a risk management plan that highlights potential problems and/or issues that may arise during the life of the contract, their impact on cost, schedule and performance, and appropriate remediation plans. This plan should reference relevant SOW elements where appropriate.

https://acc.dau.mil/CommunityBrowser.aspx?id=19545

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C.5.3. Integrated Master Schedule

The Contractor shall submit an updated Integrated Master Schedule in a format agreed upon by BARDA to the COR and the CO for approval prior to the initiation of any work to be performed under a Task Order of sufficient size and cost to require EVMS.

The Integrated Master Schedule shall be incorporated into the contract, and will be used to monitor performance of the contract.

The Contractor shall include the key milestones and Go/No Go decision gates. The Contractor will include BARDA Portfolio

Management Milestones in their IMS and provide monthly updates. This IMS shall include the following fields at a minimum;

baseline start and finish, forecast start and finish; actual start and finish, predecessor and/or successor. The Contractor shall deliver the Integrated Master Schedule, viewed at the work package level in MS Project and Portable Document (PDF) file format.

C.6. QUALITY CONTROL/ QUALITY ASSURANCE

The Contractor shall develop a quality control (QC)/quality assurance (QA) monitoring plan that ensures compliance with federal and local regulations, and the ethics committee approved protocol.

C.7. MEETINGS

The Contractor and BARDA shall participate in regular meetings to coordinate and oversee the contracting effort as requested by the Contracting Officer (CO)/Contracting Officer’s Representative (COR). Such meetings may include, but are not limited to, site visits to the Contractor’s and/or subcontractor’s facilities, and meetings with individual Contractors and other HHS officials to discuss the technical, regulatory, and ethical aspects of the program. The Contractor shall provide data, reports, and presentations to groups of outside experts and USG personnel and USG-contracted subject matter experts as required by the CO/COR facilitating review of activities.

C.8. REPORTING REQUIREMENTS

See SECTION F for specific reporting requirements.

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

Contractor. The first “kick-off” site visit will be convened within 30 days of contract award to review HHS procedures, processes and expectations, as well as Contractor’s data and plans. Program assessment will be performed by qualified subject matter experts.

C.9. SECURITY PLAN

The requirements for a Draft and Final Security Plan are set forth below in SECTION H. The Contractor’s final Security

Plan will be included as an attachment to any contract awarded under this solicitation after approval by the Contracting

Officer.

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SECTION D – PACKAGING, MARKING AND SHIPPING

D.1. METHOD OF DELIVERY

Unless otherwise specified by the Contracting Officer, delivery of all items described to be furnished to the Government under this contract (including invoices) shall be made by first class mail, overnight carrier, or email as described in SECTION F.3.

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SECTION E – INSPECTION AND ACCEPTANC11E

E.1. INSPECTION AND ACCEPTANCE

A. The Contracting Officer or the duly authorized representative will perform inspection and acceptance of materials and services to be provided.

B. For the purpose of this section, (to be filled-in at award), is the authorized representative of the Contracting Officer.

C. Inspection and acceptance will be performed at the destination of the articles, services or documentation delivered for the performance of this contract.

D. The USG hold the right to be present during the execution of the tasks as a man-in-plant.

E.2. AUDITS

The Contractor shall allow for and provide requested information to support security, quality, regulatory, and cGMP audits conducted by USG on an ad hoc basis. The estimated frequency of audits under this paragraph is annually, unless an audit for cause is determined necessary at the discretion of the Contracting Officer. If the USG finds non-compliances or deficiencies during its audit(s) on firm fixed price line items, the Contractor, at its sole expense, shall take all necessary corrective action within a timely manner. In addition, the Contractor shall provide all information requested by the USG, including the FDA, to facilitate a cGMP inspection at the time of production of pharmaceutical lots.

E.3. GOVERNMENT FEDERAL ACQUISITION REGULATION (FAR) CLAUSES INCORPORATED BY

REFERENCE

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

FAR 52.246-2, Inspection of Supplies – Fixed Price (August 1996)

FAR 52.246-3, Inspection of Supplies – Cost-Reimbursement (May 2001)

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

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

FAR 52.246-9, Inspection of Research and Development (Short Form) (April 1984)

FAR 52.246-16, Responsibility for Supplies (April 1984)

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SECTION F – DELIVERIES OR PERFORMANCE

F.1. PERIOD OF PERFORMANCE

The period of performance of this contract is anticipated to be SIXTY (60) months from date of award.

F.2. DELIVERIES

Successful performance of the final contract shall be deemed to occur upon performance of the work described in the Statement of

Objectives in SECTION C of this contract and upon delivery and acceptance of the items described in SECTION F.3 by the

Contracting Officer or their duly authorized representative.

Deliverables will be further defined upon the issuance of specific Task Orders.

F.3. CONTRACT DELIVERABLES AND REPORTING REQUIREMENTS

F.3.1. Submission of Contract Deliverables

Documents should be delivered electronically to the Contracting Officer (CO) and the Contracting Officer’s Representative

(COR). Unless otherwise specified by the Contracting Officer all deliverables and reports furnished to the Government under the resultant contract (including invoices) shall be addressed as follows:

TBD - Contracting Officer

HHS/ASPR/AMCG

330 Independence Avenue, S.W., Room G640

Washington, DC 20201

Email: TBD

TBD - Contracting Officer Representative

HHS/ASPR/BARDA

330 Independence Avenue, S.W., Room G640

Washington, DC 20201

Email: TBD

F.3.2. Reporting Requirements

In addition to those reports required by other terms of this contract, the Contractor(s) shall submit to the CO and the COR technical progress reports as identified in any awarded TO. These reports shall be subject to the technical inspection and requests for clarification by the COR. These reports shall be brief and factual and prepared in accordance with the format identified and outlined in the awarded task order.

F.4. FEDERAL ACQUISITION REGULATION (FAR) CLAUSES INCORPORATED BY REFERENCE

This contract incorporates the following clause(s) by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available. The full text of each clause may be accessed electronically at this address: http://www.acquisition.gov/comp/far/index.html.

FAR 52.242-15, Stop Work Order (August 1989)

FAR 52.242-15, Stop Work Order (August 1989), Alternate 1 (April 1984)

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SECTION G – CONTRACT ADMINISTRATION DATA

G.1. CONTRACTING OFFICER (CO)

The Contracting Officer (CO), identified below, is:

1) The only individual who can legally commit the Government to the expenditure of public funds. No person other than the Contracting Officer can make any changes to the terms, conditions, general provisions or other stipulations of this contract.

2) The CO is the only person with authority to act as agent of the Government under this contract. Only the Contracting

Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; (5) obligate or de-obligate funds into the contract; or (6) otherwise change any terms and conditions of this contract.

3) No information, other than that which may be contained in an authorized modification to this contract duly issued by the Contracting Officer, which may be received from any person employed by the United States Government, or otherwise, shall be considered grounds for deviation from any stipulation of this contract.

The Government's Contracting Officer (CO) is:

to be identified at the time of award of contract

G.2. CONTRACTING OFFICER’S REPRESENTATIVE (COR)

The Government's Contracting Officer’s Representative (COR) is:

to be identified at the time of award of contract

As delegated by the CO, the COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) assisting the CO in interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

G.3. CONTRACTOR’S POINTS OF CONTACT

The Contractor shall provide primary and secondary points of contact that will be available 24 hours per day, 7 days per week, to be notified in case of a public health emergency.

G.4. ORDERING PROCEDURES

G.4.1. Ordering Official

The Contracting Officer is the designated Ordering Official for the contract. The Contracting Officer will sign all orders

(including written confirmation of oral/telephonic orders) involving requests for supplies and/or services under this contract. Each delivery shall be accompanied by a packing slip or other evidence of delivery/performance.

G.4.2. Multiple Award Ordering

Fair opportunity will be provided to all prime Contractors for each Task Order unless one of the circumstances described in FAR

16.505(b)(2). Task Order competitions will utilize best value with “trade-off” analyses. The Government reserves the right to make multiple awards.

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G.4.3. Method of Ordering

Each RTOR issued by HHS will include a Statement of Work, Evaluation Factors for Award, Reporting Requirements and

Deliverables, required components of the offer to be submitted, format for submission, and any other issues pertinent to the Task

Order, including information on whether it is anticipated that the Task Order will be awarded with or without discussions.

Contractors shall be required to respond to all RTORs, with a notice of intent, but need not necessarily prepare a proposal for every RTOR. Contractors who do not intend to supply a proposal to the RTOT must notify the Contracting Officer in writing on or before the closing date and time established for the RTOR.

In providing services under this contract, the following procedures shall apply to the award of Task Orders. All work required under this contract shall be authorized through execution of an agreement, “Task Order,” signed by the Contractor and Contracting

Officer. The Task Order may be awarded at any time within the period of performance.

When the Government elects to fill a requirement under this contract, the Contracting Officer shall provide a RTOR.

The Government may, at its discretion, award Task Orders with optional work packages or periods of performance. The

Contractor performing the Task Order may be required to perform the optional work packages or periods of performance at the sole discretion of the Government. For example, completion of the work specified in the Task Order base period may require the development of a plan to respond to a Public Health Medical Emergency. Completion of the work in the Task Order option period may require the execution, during a Public Health Medical Emergency, of the plan developed in the base period.

If necessary, the Contracting Officer will arrange a meeting between Contractors and the Contracting Officer to discuss the proposed Task Order prior to submitting Task Order proposals (technical and business). As applicable, business proposals shall include appropriate support of all costs proposed as necessary for performing the services identified in the Task Order.

Within the time allowed for proposals preparation (time allowed for proposal preparation and submission will vary depending on the task and will be designated in each Task Order), Contractors shall submit their proposals in response to a Task Order, which shall include, but not necessarily limited to the following information:

1. Statement that the Contractor has a clear understanding of the task requirement.

2. Statement of technical and managerial resources and expertise the Contractor can provide to satisfy the requirement;

3. A schedule of performance, identify major milestones, deliverables and delivery date, and task completion; and

4. As applicable, a cost schedule necessary to complete the work.

The Government will evaluate proposals and conduct negotiations as necessary. Task Orders will be awarded to the Contractor whose proposals is determined to be the most advantageous to the Government based on the technical and cost/price factors specified in the RTOR. As specified in the RTOR, the Government reserves the right to make an award on the most favorable initials proposal without discussions.

The contracting officer is the only individual authorized to issue a Task Order under this contract. Unless specifically authorized by the contracting officer, the Contractor shall not commence work on a requirement until a fully executed Task Order has been awarded.

G.4.4. Minimum and Maximum Quantity

Minimum and maximum ordering quantities are discussed in SECTION B.5.

G.4.5. Option to Extend the Term of the Contract

Options do not apply to this contract.

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G.5. PAYMENT BY ELECTRONIC FUNDS TRANSFER (JUL 2013)

The Government shall use electronic funds transfer to the maximum extent possible when making payments under this contract.

FAR 52.232-33, Payment by Electronic Funds Transfer–Central Contractor Registration, in Section I, requires the Contractor to designate in writing a financial institution for receipt of electronic funds transfer payments.

G.6. INVOICE SUBMISSION

(a) The Contractor shall submit invoices to the Contracting Officer at the address provided in SECTION F.3. Unless otherwise specified by the Contracting Officer, two hard copies of the invoice shall be delivered by first class mail to the CO with a courtesy copy to be sent by electronic mail. The invoice shall be deemed as ‘received’ upon receipt of the hard copy of the invoice at the address provided. A sample invoice form is provided in SECTION J – Attachment 7.

(b) The Contractor agrees to include (as a minimum) the following information on each invoice:

(1) Contractor’s Name & Address

(2) Contractor’s Tax Identification Number (TIN)

(3) Contract Number

(4) Invoice Number

(5) Invoice Date

(6) Contract Line Item Number

(7) Quantity

(8) Unit Price & Extended Amount for each line item

(9) Total Amount of Invoice

(10) Name, title and telephone number of person to be notified in the event of a defective invoice

(11) Payment Address, if different from the information in (b) (1).

(c) The Contractor shall not submit an invoice prior to delivery of goods or services.

G.7. CONTRACT COMMUNICATIONS/CORRESPONDENCE

The Contractor shall identify all correspondence, reports, and other data pertinent to this contract by imprinting thereon the contract number from Page 1 of the contract.

G.8. EVALUATION OF CONTRACTOR PERFORMANCE

In accordance with FAR 42.1500, the Contractor’s performance will be periodically evaluated by the Government in order to provide current information for source selection purposes.

G.9. KEY PERSONNEL

The personnel specified in this contract are considered to be essential to the work being performed hereunder. Prior to diverting any of the specified individuals to other programs, the Contractor shall notify the Contracting Officer 30 days in advance and shall submit justification (including proposed substitutions) in sufficient detail to permit evaluation of the impact on the program. No diversion shall be made by the Contractor without the written consent of the Contracting Officer. The contract may be modified from time to time during the course of the contract to either add or delete personnel as appropriate.

Key Personnel: to be identified at the time of award of contract

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SECTION H – SPECIAL CONTRACT REQUIREMENTS

H.1. Prohibition on the Use of Appropriated Funds for Lobbying Activities (Jul 1999)

The Contractor is hereby notified of the restrictions on the use of HHS funding for lobbying of Federal, State and Local legislative bodies.

Section 1352 of Title 10, United Stated Code (Public Law 101-121, effective 12/23/89), among other things, prohibits a recipient of a Federal contract, grant, loan, or cooperative agreement from using appropriated funds (other than profits from a federal contract) to pay any person for influencing or attempting to influence an officer or employee of any agency, a Member of

Congress, an officer or employee of Congress, or an employee of a Member of Congress in connection with any of the following covered Federal actions: the awarding of any Federal contract; the making of any Federal grant; the making of any Federal loan;

the entering into of any cooperative agreement; or the modification of any Federal contract, grant, loan, or cooperative agreement.

For additional information of prohibitions against lobbying activities, see FAR Subpart 3.8 – Limitations on the Payment of Funds to Influence Federal Transactions and FAR Clause 52.203-12 (Sep 2007).

In addition, the current HHS Appropriations Act provides that no part of any appropriation contained in this Act shall be used, other than for…