A - Solicitation 14-100-SOL-00004.pdf

SECTION A

SOLICITATION, OFFER, AND AWARD 1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 350)

RATING

PAGE OF PAGES

1 | 68

2. CONTRACT NUMBER

3. SOLICITATION NUMBER

14-100-SOL-00004

4. TYPE OF SOLICITATION

SEALED BID (IFB)

NEGOTIATED (RFP)

5. DATE ISSUED

04/11/2014

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

NOTE: In sealed bid solicitations “offer” and “offeror” mean “bid” and “bidder”

SOLICITATION

9. Sealed offers in original and 2 copies plus 1 electronic PDF format on CD or USB for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if hand carried, in the depository located in Section G-1 to the Contracting Officer’s address until 2:00 p.m., local time on May 12, 2014.

CAUTION — Late Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to terms and conditions contained in this solicitation.

10. FOR A. NAME B. TELEPHONE (NO COLLECT CALLS) C. E-MAIL ADDRESS

INFORMATION CALL:

Pedro Godinez AREA CODE

NUMBER

260-8500

EXT.

Pedro.Godinez@hhs.gov

11. TABLE OF CONTENTS

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

PART I - THE SCHEDULE PART II - CONTRACT CLAUSES

X A SOLICITATION/CONTRACT FORM 1 X I CONTRACT CLAUSES 19

X B SUPPLIES OR SERVICES AND PRICE/COST 3 PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

X C DESCRIPTION/SPECS./WORK STATEMENT 5 X J LIST OF ATTACHMENTS 27

X D PACKAGING AND MARKING 8 PART IV - REPRESENTATIONS AND INSTRUCTIONS

X E INSPECTION AND ACCEPTANCE 9 K REPRESENTATIONS, CERTIFICATIONS 28

X F DELIVERIES OR PERFORMANCE 10 AND OTHER STATEMENTS OF OFFERORS

X G CONTRACT ADMINISTRATION DATA 12 L INSTRS., CONDS., AND NOTICES TO OFFERORS 39

X H SPECIAL CONTRACT REQUIREMENTS 16 M EVALUATION FACTORS FOR AWARD 64

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 _90_ calendar days (60 calendar days unless a different period is inserted by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the designated point(s), within the time specified in the schedule.

13. DISCOUNT FOR PROMPT PAYMENT

(See Section I, Clause No. 52.232-8)

10 CALENDAR DAYS

20 CALENDAR DAYS

30 CALENDAR DAYS

CALENDAR DAYS

14. ACKNOWLEDGMENT OF AMENDMENTS AMENDMENT NO. DATE AMENDMENT NO. DATE

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

15A. NAME CODE FACILITY 16. NAME AND TITLE OF PERSON AUTHORIZED TO SIGN

AND

ADDRESS

OF

OFFEROR

15B. TELEPHONE NUMBER 15C. CHECK IF REMITTANCE 17. SIGNATURE 18. OFFER DATE

AREA CODE

NUMBER

EXT.

ADDRESS IS DIFFERENT FROM ABOVE

- ENTER SUCH ADDRESS IN

SCHEDULE.

AWARD (To be completed by Government)

19. ACCEPTED AS TO ITEMS NUMBERED

20. AMOUNT

21. ACCOUNTING AND APPROPRIATION

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

10 U.S.C. 2304(c) (1) 41 U.S.C. 253(c)( )

23. SUBMIT INVOICES TO ADDRESS

SHOWN IN (4 copies unless otherwise specified)

ITEM

Clause G.3

24. ADMINISTERED BY (If other than Item 7) CODE 25. PAYMENT WILL BE MADE BY CODE

26. NAME OF CONTRACTING OFFICER (Type or print)

27. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

28. AWARD DATE

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

AUTHORIZED FOR LOCAL REPRODUCTION STANDARD FORM 33 (Rev. 9-97) Previous Edition is Unusable Prescribed by GSA – FAR (48 CFR) 53.214(c)

HHS/OS/ASPR/AMCG Page 2 of 68 Solicitation No. 14-100-SOL-00004

PART I - THE SCHEDULE

THE INFORMATION SET FORTH IN SECTION A - SOLICITATION/CONTRACT FORM,

HEREIN 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, HEREIN,

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 PERTINENT TO THE OFFEROR (I.E.,

THOSE RELATING TO THE ORGANIZATIONAL STRUCTURE [E.G., NON-PROFIT,

COMMERCIAL] AND SPECIFIC COST AUTHORIZATIONS UNIQUE TO THE OFFEROR'S

PROPOSAL AND REQUIRING CONTRACTING OFFICER PRIOR APPROVAL) WILL BE

DISCUSSED IN THE NEGOTIATION PROCESS AND IS INTENDED TO BE INCLUDED IN

ANY RESULTANT CONTRACT AWARDED TO A SUCCESSFUL OFFEROR.

HHS/OS/ASPR/AMCG Page 3 of 68

SECTION B

SUPPLIES OR SERVICES AND PRICES/COSTS

B-1 GENERAL DESCRIPTION OF SERVICES/TYPE OF CONTRACT

The contractor shall furnish all personnel, material, services, and facilities to perform the requirements set forth in the Statement of Work under Section C.

B-2 TYPE OF CONTRACT

The Government anticipates that the award from this solicitation will be a COST REIMBURSEMENT type contract. This type of contract is appropriate for this acquisition because the dynamic egg supply will be adjusted as the contractor uses eggs to meet their commercial needs as well as those of the US Government to meet the nation’s preparedness needs. More specifically, a Cost-Plus-Fixed Fee (CPFF) contract is expected to be utilized under this solicitation. The contract period of performance will be 36 months with no option periods.

B-3 COST/PRICE SCHEDULE

CLIN Supply/Service Cost Fee Cost

+FF(CPFF)

000l

Embryonated Egg Supply - Develop and maintain sufficient embryonated hens' eggs at a dynamic capacity capable of supplying at least 10 Million doses per week throughout the year.

Program Management – Manage a dynamic year round egg supply according to the approved plan.

Provide detailed plans, timelines, budgets and required reports for all items in the attached Statement of Work.

B-4 ESTIMATED COST AND FIXED FEE

a. The estimated cost of this contract is $ .

b. The fixed fee for this contract is $ . The fixed fee shall be paid in installments based on the percentage of completion of work, as determined by the Contracting Officer, and subject to the withholding provisions of the clauses ALLOWABLE COST AND PAYMENT and FIXED FEE referenced in the General Clause Listing in Part II, ARTICLE I.1. of this contract.

c. The total estimated amount of the contract, represented by the sum of the estimated cost plus the fixed fee, is $ .

B-5 COST UNALLOWABLE UNLESS AUTHORIZED BY THE CONTRACTING OFFICER

This section prohibits or restricts the use of contract funds for the following, unless otherwise approved in advance by the Contracting Officer:

a) Acquisition, by purchase or lease, of any interest in real property;

HHS/OS/ASPR/AMCG Page 4 of 68

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 provide; (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-6 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

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.

HHS/OS/ASPR/AMCG Page 5 of 68

SECTION C

DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

C-1 INTRODUCTION AND BACKGROUND

A. INTRODUCTION AND PURPOSE

The purpose of this requirement is to support the Biomedical Advance Research and

Development Authority's (BARDA) mission of 'A Nation Prepared' to rapidly respond and produce a strain-matched pandemic influenza vaccine in the event of a declared pandemic by:

assure the year-round availability of sufficient embryonated hens’ eggs to support production of pandemic influenza vaccine at dynamic capacity.

B. BACKGROUND

Historically, several pandemics of influenza have been described each century for the past 500 years. The 2009 outbreak of H1N1 is the most recent example. The threat of a new pandemic caused by emerging influenza viruses has continued, as outbreaks of H5N1 virus infection in poultry and man have continued since late 2003 and the recent outbreak of H7N9 infections in man have demonstrated. The global population has little or no immunity to H5N1 and H7N9 viruses and these viruses are highly pathogenic man (mortality rate ~ 60% in man and 30%, respectively). The periodic emergence of influenza viruses of novel subtypes means there is great uncertainty in regard to when the next pandemic will occur and which virus will emerge to be the cause.

C-2 STATEMENT OF WORK

In less than 100 years there have been four influenza pandemics: The Spanish Flu of 1918, the Asian Flu of 1957, the Hong Kong Flu of 1968, and most recently the 2009 H1N1 outbreak. Vaccine is the primary medical countermeasure for the prevention of seasonal and pandemic influenza. Production of a vaccine to immunize against the influenza strain causing the next pandemic must occur as quickly as possible at any time of year. The ability to support this objective currently is limited by the seasonal nature of influenza vaccine production that translate to seasonal variability in the availability of supplies essential for egg-based vaccine manufacture. This program assures the early availability of a sufficient quantity of vaccine for the U.S. population in the setting of a pandemic will potentially prevent thousands of deaths and save billions of dollars.

The Department of Health and Human Services (HHS) has an obligation to promote capabilities that assure a pandemic vaccine can be produced at a U.S.-licensed influenza vaccine facility at any time of the year, without limitations imposed by the availability of essential supplies. This program is designed to support these interests.

HHS/OS/ASPR/AMCG Page 6 of 68

C-3 SERVICES TO BE PERFORMED (TASKS)

The Contractor, as an independent organization and not as an agent of the Government, shall furnish all of the necessary services, qualified personnel, materials, equipment and facilities not otherwise provided by the Government to complete the following tasks:

TASK ONE

Develop, submit, and implement on approval, a plan (or a revised plan if this is a continuation) within three (3) months of Contract Award, including critical events and milestones, to put in place a three (3) year program to assure pandemic influenza vaccine production capability, by maintaining a dynamic capacity of embryonated eggs to produce at least 10 million monovalent doses per week for emergency production when not in seasonal production and at the full site capacity when in seasonal production. (Assume four adjuvanted monovalent doses per egg). This plan must address each of the following areas:

a) Provide and maintain a dynamic capacity of embryonated eggs that is capable of producing at least 10 million monovalent doses per week for emergency production year round. When in seasonal influenza vaccine production the number of embryonated eggs maintained cannot exceed the number of eggs needed for full capacity production at the vaccine manufacturing site.

b) Define current gaps in availability of embryonated eggs for vaccine production, including specification of time periods during the year and total number of potential production days.

Include a description of production capability and egg supply needs if i) a monovalent pandemic vaccine were to be produced at the same time as production of the annual trivalent vaccine and ii) a monovalent pandemic vaccine were to be produced during a period when annual, interpandemic trivalent vaccine was not being produced.

c) Provide a surge production plan and schedule of embryonated egg supply in the event of a pandemic declaration.

d) Implement a strategy for contracting with farmers to assure the availability of a sufficient quantity and quality of embryonated eggs suitable for vaccine production on a year round basis.

e) Provide evidence that the contracts to provide the approved level of embryonated eggs can be completed with the farmers within four (4) months of contract award.

f) As needed, describe procedures for the storage and disposal/disposition of embryonated hens eggs that are not used in manufacturing (eggs produced not taken) to minimize waste and costs to the government.

TASK TWO

Implement the approved plan as described in TASK ONE, for production and delivery of embryonated eggs as directed by the Government.

TASK THREE

Identify potential barriers to successful completion of the scope of work and describe a risk management plan that will be implemented to assure successful completion of tasks.

HHS/OS/ASPR/AMCG Page 7 of 68

TASK FOUR

Meet with the Contracting Officer, Contracting Officer’s Representative (COR) and/or his/her designee(s) at periodic intervals, to be scheduled after award.

TASK FIVE

Provide an estimated expenditure profile, including the periods of implementation for all elements of this scope of work.

TASK SIX

Provide written monthly progress reports of tasks accomplished and overall status of project. This report shall address all flock and egg production status, any problem areas and the contractor's plan to address and resolve these problems.

TASK SEVEN

Submit a written final report summarizing the accomplishments and final status of the project.

C-4 REPORTING REQUIREMENTS

All reports required herein shall be submitted in electronic format. In addition, two hard copies of each report shall be submitted, one to the Contracting Officer and one to the Contracting Officer’s Representative.

All electronic reports submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at:

http://www.hhs.gov/web/508/index.html under "Making Files Accessible."

All paper/hardcopy documents/reports submitted under this contract shall be printed or copied, double-sided, on at least 30 percent post-consumer fiber paper, whenever practicable, in accordance with FAR 4.302(b).

1. In addition to the required reports set forth elsewhere in this Schedule, the preparation and submission of regularly recurring Technical Progress Reports will be required. These reports will require descriptive information about the activities undertaken during the reporting period and information about planned activities for future reporting periods. The frequency and specific content of these reports will be determined prior to contract award.

It is estimated that in addition to the required electronic version(s) 2 hard copies of these reports will be required as follows:

Description Copies Due Date Monthly Progress Reports per paragraph II.7

1 to COR 1 to CO

30 days after contract award and month thereafter, due on the 15th of each month

Final Project Report per paragraph II.8

1 to COR 1 to CO

Due with delivery of the final invoice for this contract.

http://www.hhs.gov/web/508/index.html http://www.hhs.gov/web/508/index.html

HHS/OS/ASPR/AMCG Page 8 of 68

SECTION D

PACKAGING, MARKING AND SHIPPING

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and Contractor name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

D-1 ADDRESSESS: For all contract deliverables.

Contracting Officer’s Representative

HHS/OS/ASPR/BARDA

330 Independence Avenue, SW Room G644 Washington, DC 20201

Contracting Officer

HHS/OS/ ASPR/ AMCG

330 Independence Avenue, SW Room G644 Washington, DC 20201

HHS/OS/ASPR/AMCG Page 9 of 68

SECTION E

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, the designated Contracting Officer’s Representative is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Assistant Secretary for Preparedness & Response Washington, DC 20024

Acceptance may be presumed unless otherwise indicated in writing by the Contracting Officer or the duly authorized representative within 30 days of receipt.

d. FEDERAL ACQUISITION REGULATION CLAUSES INCORPORATED BY REFERENCE

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

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

HHS/OS/ASPR/AMCG Page 10 of 68

SECTION F

DELIVERIES OR PERFORMANCE

F-1 PERIOD OF PERFORMANCE

The period of performance of this contract shall be from contract award date through 36 months.

All work and services required hereunder including preparation and submission of all deliverables shall be completed within 36 months of the effective date of the contract.

F-2 CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY 1998)

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. Also, the full text of a clause may be accessed electronically at this address: http://www.acquisition.gov/far

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

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

F-3 DELIVERIES

Successful performance of the final contract shall be deemed to occur upon performance of the work described in the Statement of Work Article in SECTION C of this contract and upon delivery and acceptance by the Contracting Officer of the following items in accordance with the stated delivery schedule:

F-4 FINAL REPORT

The Contractor shall submit a comprehensive Final Report that details, documents, and summarizes the results of the entire contract work. The report shall explain comprehensively the results achieved.

It shall also contain a summary of all Tasks performed under the contract and a determination that everything under the contract has been completed and accepted. A draft Final Report shall be submitted to the CO and COR for review and comment at least 45 days prior to contract expiration date. Upon final acceptance by the CO, an electronic copy shall be submitted to the CO not later than 30 days following the expiration date of the contract.

F-5 DELIVERY SCHEDULE

The items specified below as described in the REPORTING REQUIREMENTS Article in SECTION C of this contract will be required to be delivered F.o.b. Destination as set forth in FAR 52.247-35, F.o.b. DESTINATION, WITHIN CONSIGNEES PREMISES (APRIL 1984), and in accordance with and by the date(s) specified below and any specifications stated in SECTION D, PACKAGING, MARKING AND SHIPPING, of this contract:

http://www.acquisition.gov/far

HHS/OS/ASPR/AMCG Page 11 of 68

Task Description Deliverable/format Approx. due date

Develop, submit, and implement on approval, an original or revised plan within three months of Contract Award, including critical events and milestones, to put in place a 36 month (3 year) program to assure pandemic influenza vaccine production capability, by maintaining a dynamic capacity of embryonated eggs to produce at least 10 million monovalent doses per week for emergency production when not in seasonal production and not to exceed the full site capacity when in seasonal production.

One copy to the contracting officer and one copy to the contract officer’s representative (COR) in PDF format.

Within three (3) months of contract award

3 Develop and provide a risk management plan for the identified risks to the program.

One copy to the contracting officer and one copy to the COR in PDF format.

Within three

(3) months of contract award

4 Submit a site visit report summarizing the discussions that occurred during HHS personnel site visit.

One copy to the contracting officer and one copy to the COR in PDF format.

Within two (2) weeks after date of Site Visit by HHS personnel

5 Develop a detailed timeline and budget for all items in the attached Statement of Work.

One copy to the contracting officer and one copy to the COR in PDF format

Within three

(3) months of contract award

6 Provide a monthly report on program progress

One copy to the contractingofficer and one copy to the COR in PDF format

Within thirty

(30) days of contract award and monthly thereafter on the 15th of the month

7 Provide a final program report One copy to the contracting officer and one copy to the COR in PDF format

Within thirty

(30) days of contract completion

HHS/OS/ASPR/AMCG Page 12 of 68

SECTION G

CONTRACT ADMINISTRATION DATA

G-1 CONTRACTING OFFICER (CO)

1) The Contracting Officer (CO) is 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.

4) The contractor shall submit all correspondence that in any way concerns the terms or conditions of this contract shall be submitted directly to the Contracting Officer at the following address:

Office of Aquisition Management Contracts & Grants (AMCG) Assistant Secretary for Preparedness and Response (ASPR) Department of Health and Human Services 330 Independence Ave., SW, RM G644

Contracting Officer: Linda Luczak E-mail Address: Linda.Luczak@hhs.gov

Contract Specialist: Pedro Godinez E-mail Address: Pedro.Godinez@hhs.gov Telephone Number: 202-260-8500

G-2 CONTRACTING OFFICER'S REPRESENTATIVE (COR)

The following Contracting Officer's Representative (COR) will represent the Government for the purpose of this contract:

{To Be Determined}

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.

HHS/OS/ASPR/AMCG Page 13 of 68

G-3 KEY PERSONNEL, HHSAR 352.242-70 (January 2006)

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to diverting any of the specified individuals to other programs or contracts (or as soon as possible, if an individual must be replaced, for example, as a result of leaving the employ of the Contractor), the Contractor shall notify the Contracting Officer and shall submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this contract.

The Contractor shall not divert or otherwise replace any key personnel without the written consent of the Contracting Officer. The Government may modify the contract to add or delete key personnel at the request of the Contractor or Government.

(End of Clause)

The following individual(s) is/are considered to be essential to the work being performed hereunder:

Name Title

G-4 SUBSTITUTION OF KEY PERSONNEL

(a) The offeror agrees to assign to the contract those persons whose resumes were submitted with the proposal who are necessary to fill the requirements of the contract. No substitutions shall be made except in accordance with this clause.

(b) All requests for substitution must provide a detailed explanation of the circumstance necessitating the proposed substitution, a complete resume for the proposed substitute and any other information requested by the contracting officer to approve or disapprove the proposed substitution. All proposed substitutes must have qualifications that are equal to or higher than the qualifications of the person to be replaced. The contracting officer or authorized representative will evaluate such requests and promptly notify the contractor of his approval or disapproval thereof.

(c) The contractor further agrees to include the substance of this clause in any subcontract, which may be awarded under this contract.

G-5 CONTRACT ADMINISTRATION

The contractor's representative responsible for handling contract administration is:

NAME TITLE TELEPHONE# ADDRESS

To Be Filled-In By Contractor

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.

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G-6 INVOICE SUBMISSION & PAYMENT RELATED INFORMATION

You must submit all invoices by regular mail, FedEx, etc., but not by hand or courier. Your invoice must include all of the elements of a proper invoice as defined in the invoice or payment clause used in this award as well as any other information required below or in the contract. No more than one invoice may be submitted per month.

Submit an original and one (1) copy of the invoice to:

Office of Acquisition Management Contracts & Grants Assistant Secretary for Preparedness and Response Department of Health and Human Services 330 Independence Ave, SW, RM G644 Washington, DC 20201 Attn: Pedro Godinez

TAXPAYER IDENTIFICATION NUMBER (TIN) AND DUN&BRADSTREET NUMBER

(DUNS):

In order to assist the government in making timely payments, please include your TIN, your DUNS#, and the Order Number on each invoice.

SUBMISSION OF ELECTRONIC FUNDS TRANSFER (EFT) INFORMATION AND

REMITTANCE INFORMATION:

The Government shall make payment to the Contractor using the EFT information contained in the System for Award Management (SAM) database. In the event that the EFT information changes, the Contractor shall be responsible for providing the updated information to the SAM database.

Remittance information associated with EFT payments is now available via the Payment Advice Internet Delivery (PAID) System on the Department of Treasury's Internet site at https://fmsapps.treas.gov/paid/security/PAIDlogin.asp. This site provides an explanation of the system, how it works, security and access information, a user demonstration, and registration information. There is no charge to use the PAID system.

G-7 POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

a. Contractor Performance Evaluations

Interim and Final evaluations of Contractor performance will be prepared on this contract in accordance with FAR Subpart 42.15. The Final performance evaluation will be prepared at the time of completion of work. In addition to the Final evaluation, Interim evaluation(s) will be prepared annually as follows on TO BE DETERMINED AT TIME OF AWARD.

Interim and Final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted thirty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final.

https://fmsapps.treas.gov/paid/security/PAIDlogin.asp

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Copies of the evaluations, Contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions.

b. Electronic Access to Contractor Performance Evaluations

Contractors may access evaluations through a secure Web site for review and comment at the following address: http://www.cpars.gov

G-8 PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS

SUBCONTRACTORS, FAR 52.232-40 (December 2013)

a. Upon receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor.

b. The acceleration of payments under this clause does not provide any new rights under the prompt Payment Act.

c. Include the substance of this clause, include this paragraph c, in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial items.

(End of Clause)

G-9 NEGOTIATED INDIRECT COST RATES

Pending the establishment of final indirect cost rates which shall be negotiated based on audit of actual costs as provided in Subpart 42.7 of the Federal Acquisition Regulation, the Contractor shall be reimbursed for allowable indirect costs hereunder at the billing rate of [_TO BE NEGOTIATED_]. This INDIRECT COST provision does not operate to waive the LIMITATION OF FUNDS Clause. The Contractor's audited final indirect costs are allowable only insofar as they do not cause the Contractor to exceed the total estimated costs for performance of the contract listed in SECTION B.

Beginning with the effective date of this contract, indirect costs shall be reimbursed at the following provisional rates:

INDIRECT COST

YEAR 1 YEAR 2 YEAR 3

RATE RATE RATE

TO BE DETERMINED

Final indirect cost rates shall not exceed the following ceiling rates

INDIRECT COST RATE

TO BE DETERMINED

http://www.cpars.gov/

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SECTION H

SPECIAL CONTRACT REQUIREMENT

H-1 HUMAN SUBJECTS

It is hereby understood and agreed that research involving human subjects shall not be conducted under this contract, and that no material developed, modified, or delivered by or to the Government under this contract, or any subsequent modification of such material, will be used by the Contractor or made available by the Contractor for use by anyone other than the Government, for experimental or therapeutic use involving humans without the prior written approval of the Contracting Officer.

H-2 HUMAN MATERIALS

The acquisition and supply of all human specimen material (including fetal material) used under this contract shall be obtained by the Contractor in full compliance with applicable State and Local laws and the provisions of the Uniform Anatomical Gift Act in the United States, and no undue inducements, monetary or otherwise, will be offered to any person to influence their donation of human material.

H-3 NEEDLE DISTRIBUTION

The Contractor shall not use contract funds to carry out any program of distributing sterile needles or syringes for the hypodermic injection of any illegal drug.

H-4 ACKNOWLEDGEMENT OF FEDERAL FUNDING

The Contractor shall clearly state, when issuing statements, press releases, requests for proposals, bid solicitations and other documents describing projects or programs funded in whole or in part with Federal money: (1) the percentage of the total costs of the program or project which will be financed with Federal money; (2) the dollar amount of Federal funds for the project or program; and (3) the percentage and dollar amount of the total costs of the project or program that will be financed by nongovernmental sources.

H-5 CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH

The Contractor shall not use contract funds for (1) the creation of a human embryo or embryos for research purposes; or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR 46.204(b) and Section 498(b) of the Public Health Service Act (42 U.S.C.

289g(b)). The term "human embryo or embryos" includes any organism, not protected as a human subject under 45 CFR 46 as of the date of the enactment of this Act, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells.

Additionally, in accordance with a March 4, 1997 Presidential Memorandum, Federal funds may not be used for cloning of human beings.

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H-6 SUBCONTRACTING PROVISIONS

a. Small Business Subcontracting Plan

1. The Small Business Subcontracting Plan, dated is attached hereto and made a part of this contract.

2. The failure of any Contractor or subcontractor to comply in good faith with FAR Clause 52.219-8, entitled "Utilization of Small Business Concerns" incorporated in this contract and the attached Subcontracting Plan, will be a material breach of such contract or subcontract and subject to the remedies reserved to the Government under FAR Clause 52.219-16 entitled, "Liquidated Damages-Subcontracting Plan."

b. Subcontracting Reports

The Contractor shall submit the following Subcontracting reports electronically via the "electronic Subcontracting Reporting System (eSRS) at http://www.esrs.gov .

1. Individual Subcontract Reports (ISR)

Regardless of the effective date of this contract, the Report shall be due on the following dates for the entire life of this contract:

April 30th October 30th Expiration Date of Contract

2. Summary Subcontract Report (SSR)

Regardless of the effective date of this contract, the Summary Subcontract Report shall be submitted annually on the following date for the entire life of this contract:

October 30th

For both the Individual and Summary Subcontract Reports, the Contract Specialist shall be included as a contact for notification purposes at the following e-mail address: Pedro.Godinez@hhs.gov

H-7 PUBLICATION AND PUBLICITY

In addition to the requirements set forth in HHSAR Clause 352.227-70, Publications and Publicity incorporated by reference in SECTION I of this contract, the Contractor shall acknowledge the support of the U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority whenever publicizing the work under this contract in any media by including an acknowledgment substantially as follows:

"This project has been funded in whole or in part with Federal funds from the , U.S. Department of Health and Human Services, Office of the http://www.esrs.gov/ mailto:Pedro.Godinez@hhs.gov

HHS/OS/ASPR/AMCG Page 18 of 68

Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under Contract No. "

H-8 REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE

Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in U.S.

HHS funded programs is encouraged to report such matters to the HHS Inspector General's Office in writing or on the Inspector General's Hotline. The toll free number is 1-800-HHS-TIPS (1-800-447- 8477). All telephone calls will be handled confidentially. The website to file a complaint on-line is:

http://oig.hhs.gov/fraud/hotline/ and the mailing address is:

US Department of Health and Human Services Office of Inspector General

ATTN: OIG HOTLINE OPERATIONS

P.O. Box 23489 Washington, D.C. 20026

H-9 NOTICE PRIOR TO PUBLICATION

The Contractor shall not release any reports, manuscripts, press releases, or abstracts about the work being performed under this contract without written notice in advance to the Government, for additional information see HHSAR 352.270-6.

The Government recognizes that manuscripts, press releases and or abstracts may have already been drafted and inquiries made to peer reviewed journals or scientific organizations regarding rapid publications

H-10 MANUFACTURING STANDARDS

The Current Good Manufacturing Practice Regulations (cGMP) (21 CFR Parts 210-211) will be the standard to be applied for manufacturing, processing and packing of this therapeutic product.

If at any time during the life of the contract, the Offeror fails to comply with cGMP in the manufacturing, processing and packaging of this therapeutic product and such failure results in a material adverse effect on the safety, purity or potency of this therapeutic product (a material failure) as identified by CBER and CDER, the Offeror shall have thirty (30) calendar days from the time such material failure is identified to cure such material failure. If the Offeror fails to take such an action within the thirty (30) calendar day period, then the contract may be terminated.

H-11 PROHIBITION ON CONTRACTOR INVOLVEMENT WITH TERRORIST ACTIVITIES

The Contractor acknowledges that U.S. Executive Orders and Laws, including but not limited to E.O.

13224 and P.L. 107-56, prohibit transactions with, and the provision of resources and support to, individuals and organizations associated with terrorism. It is the legal responsibility of the Contractor to ensure compliance with these Executive Orders and Laws. This clause must be included in all subcontracts issued under this contract.

http://oig.hhs.gov/fraud/hotline/ http://oig.hhs.gov/fraud/hotline/

HHS/OS/ASPR/AMCG Page 19 of 68

PART II – CONTRACT CLAUSES

SECTION I - CONTRACT CLAUSES

I-1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (Feb 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these addresses:

http://www.acquisition.gov/far/ http://www.hhs.gov/regulations/hhsar/

a. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES:

Clause Date Clause Title

FAR 52.202-1 Nov 2013 Definitions (Over the Simplified Acquisition Threshold)

FAR 52.203-3 Apr 1984 Gratuities (Over the Simplified Acquisition Threshold)

FAR 52.203-5 Apr 1984 Covenant Against Contingent Fees (Over the Simplified Acquisition Threshold)

FAR 52.203-6 Sep 2006 Restrictions on Subcontractor Sales to the Government (Over the Simplified Acquisition Threshold)

FAR 52.203-7 Oct 2010 Anti-Kickback Procedures (Over the Simplified Acquisition Threshold)

FAR 52.203-8 Jan 1997 Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity (Over the Simplified Acquisition Threshold)

FAR 52.203-10 Jan 1997 Price or Fee Adjustment for Illegal or Improper Activity (Over the Simplified Acquisition Threshold)

FAR 52.203-12 Oct 2010 Limitation on Payments to Influence Certain Federal Transactions (Over $150,000)

FAR 52.203-13 Apr 2010 Contractor Code of Business Ethics and Conduct http://www.acquisition.gov/far/ http://www.hhs.gov/regulations/hhsar/

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FAR 52.203-14 Dec 2007

Display of Hotline Poster(s) ".....(3) Any required posters may be obtained as follows:

Poster(s) Obtain From" HHS Contractor Code of Ethics and Business Conduct Poster http://oig.hhs.gov/fraud/report-fraud/OIG_Hotline_Poster.pdf

FAR 52.204-4 May 2011 Printed or Copied Double-Sided on Postconsumer Fiber Content Paper(Over the Simplified Acquisition Threshold)

FAR 52.204-7 Dec 2012 Central Contractor Registration

FAR 52.204-10 Jul 2013 Reporting Executive Compensation and First-Tier Subcontract Awards ($25,000 or more)

FAR 52.209-6 Aug 2013 Protecting the Government's Interest When Subcontracting With Contractors Debarred, Suspended, or Proposed for Debarment (Over $30,000)

FAR 52.210-1 Apr 2011 Market Research

FAR 52.215-2 Oct 2010

Audit and Records - Negotiation [Note: Applies to ALL contracts funded in whole or in part with Recovery Act funds, regardless of dollar value, AND contracts over the Simplified Acquisition Threshold funded exclusively with non-Recovery Act funds.]

FAR 52.215-8 Oct 1997 Order of Precedence - Uniform Contract Format

FAR 52.215-10 Aug 2011 Price Reduction for Defective Certified Cost or Pricing Data (Over $700,000)

FAR 52.215-11 Aug 2011 Price Reduction for Defective Certified Cost or Pricing Data - Modifications

FAR 52.215-12 Oct 2010 Subcontractor Cost or Pricing Data (Over $700,000)

FAR 52.215-15 Oct 2010 Pension Adjustments and Asset Reversions (Over $700,000)

FAR 52.215-18 Jul 2005 Reversion or Adjustment of Plans for Post-Retirement Benefits (PRB) other than Pensions

FAR 52.215-19 Oct 1997 Notification of Ownership Changes http://oig.hhs.gov/fraud/report-fraud/OIG_Hotline_Poster.pdf http://oig.hhs.gov/fraud/report-fraud/OIG_Hotline_Poster.pdf

HHS/OS/ASPR/AMCG Page 21 of 68

FAR 52.215-21 Oct 2010 Requirements for Certified Cost or Pricing Data and Data Other Than Certified Cost or Pricing Data - Modifications

FAR 52.215-23 Oct 2009 Limitations on Pass-Through Charges (Over the Simplified Acquisition Threshold)

FAR 52.216-7 Jun 2013 Allowable Cost and Payment

FAR 52.216-8 Jun 2011 Fixed Fee

FAR 52.219-8 Jul 2013 Utilization of Small Business Concerns (Over the Simplified Acquisition Threshold)

FAR 52.219-9 Jul 2013 Small Business Subcontracting Plan (Over $650,000, $1.5 million for Construction)

FAR 52.219-16 Jan 1999 Liquidated Damages - Subcontracting Plan (Over $650,000, $1.5 million for Construction)

FAR 52.219-25 Jul 2013 Small Disadvantaged Business Participation Program – Disadvantaged Status and Reporting

FAR 52.219-28 Jul 2013 Post-Award Small Business Program Representation

FAR 52.222-2 Jul 1990

Payment for Overtime Premium (Over the Simplified Acquisition Threshold) (Note: The dollar amount in paragraph (a) of this clause is $0 unless otherwise specified in the contract.)

FAR 52.222-3 Jun 2003 Convict Labor

FAR 52.222-4 Jul 2005 Contract Work Hours and Safety Standards Act – Overtime Compensation - General

FAR 52.222-21 Feb 1999 Prohibition of Segregated Facilities

FAR 52.222-26 Mar 2007 Equal Opportunity

FAR 52.222-35 Sep 2010 Equal Opportunity for Veterans ($100,000 or more)

FAR 52.222-36 Oct 2010 Affirmative Action for Workers with Disabilities

FAR 52.222-37 Sep 2010 Employment Reports on Veterans ($100,000 or more)

FAR 52.222-40 Dec 2010 Notification of Employee Rights Under the National Labor Relations Act (Over the Simplified Acquisition Threshold)

FAR 52.222-41 Nov 2007 Service Contract Act of 1965

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FAR 52.222-43 Sep 2009 Fair Labor Standards Act and Service Contract Act – Price Adjustments (Multiple Year and Option Contracts)

FAR 52.222-50 Feb 2009 Combating Trafficking in Persons

FAR 52.222-54 Aug 2013 Employment Eligibility Verification (Over the Simplified Acquisition Threshold)

FAR 52.223-6 May 2001 Drug-Free Workplace

FAR 52.223-18 Aug 2011 Encouraging Contractor Policies to Ban Text Messaging While Driving

FAR 52.225-1 Feb 2009 Buy American Act - Supplies

FAR 52.225-13 Jun 2008 Restrictions on Certain Foreign Purchases

FAR 52.227-1 Dec 2007 Authorization and Consent

FAR 52.227-2 Dec 2007 Notice and Assistance Regarding Patent and Copyright Infringement

FAR 52.227-3 Apr 1984 Patent Indemnity

FAR 52.227-14 Dec 2007 Rights in Data - General

FAR 52.227-16 Jun 1987 Additional Data Requirements

FAR 52.229-3 Feb 2013 Federal, State and Local Taxes

FAR 52.230-2 May 2012 Cost Accounting Standards

FAR 52.230-6 Jun 2010 Administration of Cost Accounting Standards

FAR 52.232-1 Apr 1984 Payments

FAR 52.232-8 Feb 2002 Discounts for Prompt Payment

FAR 52.232-9 Apr 1984 Limitation on Withholding of Payments

FAR 52.232-11 Apr 1984 Extras

FAR 52.232-17 Oct 2010 Interest (Over the Simplified Acquisition Threshold)

FAR 52.232-20 Apr 1984 Limitation of Cost

FAR 52.232-23 Jan 1986 Assignment of Claims

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FAR 52.232-25 Jul 2013 Prompt Payment, Alternate I (Feb 2002)

FAR 52.232-33 Jul 2013 Payment by Electronic Funds Transfer--System for Award Management

FAR 52.232-39 Jun 2013 Unenforceability of Unauthorized Obligations

FAR 52.233-1 Jul 2002 Disputes

FAR 52.233-3 Aug 1996 Protest After Award, Alternate I (Jun 1985)

FAR 52.233-4 Oct 2004 Applicable Law for Breach of Contract Claim

FAR 52.237-3 Jan 1991 Continuity of Services

FAR 52.242-1 Apr 1984 Notice of Intent to Disallow Costs

FAR 52.242-3 May 2001 Penalties for Unallowable Costs (Over $700,000)

FAR 52.242-4 Jan 1997 Certification of Final Indirect Costs

FAR 52.242-13 Jul 1995 Bankruptcy (Over the Simplified Acquisition Threshold)

FAR 52.243-2 Aug 1987 Changes - Cost Reimbursement, Alternate I (Apr 1984)

FAR 52.244-2 Oct 2010 Subcontracts (Over the Simplified Acquisition Threshold), Alternate I (June 2007)

FAR 52.244-5 Dec 1996 Competition in Subcontracting (Over the Simplified Acquisition Threshold)

FAR 52.244-6 Dec 2013 Subcontracts for Commercial Items

FAR 52.245-1 Apr 2012 Government Property

FAR 52.245-9 Apr 2012 Use and Charges

FAR 52.246-23 Feb 1997 Limitation of Liability

FAR 52.246-25 Feb 1997 Limitation of Liability - Services (Over the Simplified Acquisition Threshold)

FAR 52.249-6 May 2004 Termination (Cost-Reimbursement)

FAR 52.249-14 Apr 1984 Excusable Delays

FAR 52.253-1 Jan 1991 Computer Generated Forms

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b. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION

(HHSAR)

(48 CFR CHAPTER 3) CLAUSES

HHSAR352.201-70 Jan 2006 Paperwork Reduction Act

HHSAR 352.202-1 Jan 2006 Definitions - with Alternate paragraph (h) (Jan 2006)

HHSAR 352.203-70 Mar 2012 Anti-Lobbying

HHSAR 352.215-70 Jan 2006 Late Proposals and Revisions

HHSAR 352.216-70 Jan 2006 Additional Cost Principles

HHSAR 352.222-70 Jan 2010 Contractor Cooperation in Equal Employment Opportunity Investigations

HHSAR 352.223-70 Jan 2006 Safety and Health

HHSAR 352.227-70 Jan 2006 Publications and Publicity

HHSAR 352.228-7 Dec 1991 Insurance - Liability to Third Persons

HHSAR 352.231-71 Jan 2001 Pricing of Adjustments

HHSAR 352.233-71 Jan 2006 Litigation and Claims

HHSAR 352.242-70 Jan 2006 Key Personnel

HHSAR 352.242-73 Jan 2006 Withholding of Contract Payments

HHSAR 352.242-74 Apr 1984 Final Decisions on Audit Findings

I-2 ADDITIONAL FAR CLAUSES INCLUDED IN FULL TEXT

Additional clauses other than those listed below which are based on the type of contract/Contractor shall be determined during negotiations. Any contract awarded from this solicitation will contain the following:

This contract incorporates the following clauses in full text.

a. FEDERAL ACQUISITION REGULATION (FAR)(48 CFR CHAPTER 1) CLAUSES:

1. FAR Clause 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (July 2013)

As prescribed in 32.706-1(b), insert the following clause:

HHS/OS/ASPR/AMCG Page 25 of 68

a. The Contractor shall update the information in the Federal Awardee Performance and

Integrity Information System (FAPIIS) on a semi-annual basis, throughout the life of the contract, by posting the required information in the System for Award Management (SAM) database at…