RFP_Ancillary_Supplies_2013.pdf

RFP 13-100-SOL-00015

TABLE OF CONTENTS

Part I – The Schedule

Page #

SECTION A – SOLICITATION/CONTRACT FORM AND TABLE 1

OF CONTENTS

SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS 2

SECTION C – DESCRIPTION/SPECS/WORK STATEMENT 8

SECTION D – PACKAGING AND MARKING 13

SECTION E – INSPECTION AND ACCEPTANCE 14

SECTION F – DELIVERIES OR PERFORMANCE 15

SECTION G – CONTRACT ADMINISTRATION DATA 18

SECTION H – SPECIAL CONTRACT REQUIREMENTS 24

Part II – Contract Clauses

SECTION I – CONTRACT CLAUSES 26

Part III – Attachments

SECTION J – LIST OF ATTACHMENTS 33

Part IV – Representations and Instructions

SECTION K – REPRESENTATIONS, CERTIFICATIONS AND OTHER

STATEMENTS OF OFFERORS 34

SECTION L – INSTRUCTIONS, CONDITIONS AND NOTICES

TO OFFERORS 36

SECTION M – EVALUATION FACTORS FOR AWARD 53

ATTACHMENTS 1 THROUGH 5

(FOLLOWING PAGE 55 OF THE SOLICITATION)

SECTION B SUPPLIES OR SERVICES AND PRICES/COSTS

B.1 Description of Supplies or Services

The goal of this solicitation is to acquire ancillary materials (needles and syringes) from medical/surgical device manufacturers to meet the vaccine administration needs of the American public during a pandemic influenza event. To ensure coverage, manufacturers are expected to acquire, maintain and rotate inventories of integrated needle and syringe units of various types for pandemic preparedness. The management of these materials will be coordinated and integrated by HHS/ASPR/BARDA to provide long-term solutions that address and satisfy the vaccine administration requirements during pandemic influenza events.

B.2 Contract Line Item Numbers (CLINs)

The following Contract Line Item Number (CLIN) descriptions and tables represent the bid schedule that the Contractor shall use to develop their cost breakdown and deliverables.

Contractors are encouraged to propose sub-CLINs where necessary to delineate specific activities within the CLIN.

Task /Delivery Order Requests (T/DORs) for any of the services as described in the Statement of Work (SOW) may be issued. Each T/DOR will specify its own period of performance. T/DORs may be issued at any time during the contract but the T/DORs period of performance shall in no event exceed the contract period of performance.

Base Period

Item # Supply or Service Unit Unit Price Extended

Price 0001 Integrated Needle/Syringe

Unit, FDA approved, safety engineered

0001AA 3mlsyringe/23Gx1” Needle Each 0001AB 3mlsyringe/25Gx1” Needle Each 0002 Integrated Needle/Syringe

Unit, 5ml or 6ml Syringe, 20Gx1” Needle

0003 Needle, FDA approved, Safety engineered, Luer- Lock

Each

0003AA Needle, 23Gx1” Each 0003AB Needle, 25Gx1” Each 0003AC Needle, 25Gx5/8” Each 0004 Syringe, 3ml, FDA approved, Safety Engineered, Luer-Lock

Each

0005 Isopropyl Alcohol Each

Impregnated Prep Pads, Sterile, individually sealed,small

0006 Integrated Needle/Syringe Unit, FDA approved, conventional

0006AA 3mlsyringe/23Gx1” Needle, Conventional

Each

0006AB 3mlsyringe/25Gx1” Needle, Conventional

Each

0007 Report – manufacturing/production schedule

Each Not separately priced

0008 Report – delivery schedule Each Not

0009 Vendor Management Pallet 0010 Handling and Shipment Pallet 0011 Product Exchange Each 0012 Disposal Each 0013 Reports Each

Option Year #1 Item # Supply or Service Unit Unit Price Extended

Price 0001 Integrated Needle/Syringe

0002 Integrated Needle/Syringe

Lock

Each

0003AA Needle, 23Gx1” Each 0003AB Needle, 25Gx1” Each 0003AC Needle, 25Gx5/8” Each 0004 Syringe, 3ml, FDA approved, Safety Engineered, Luer- Lock

Each

0005 Isopropyl Alcohol Impregnated Prep Pads, Sterile, individually sealed,small

Each

0006 Integrated Needle/Syringe conventional

0006AA 3mlsyringe/23Gx1” Needle, Conventional

Each

0006AB 3mlsyringe/25Gx1” Needle, Conventional

Each

0007 Report – manufacturing/production schedule

Each Not

0011 Product Exchange Each 0012 Disposal Each 0013 Reports Each Not

Option Year #2 Item # Supply or Service Unit Unit Price Extended

Price 0001 Integrated Needle/Syringe

0002 Integrated Needle/Syringe

Lock

Each

0003AA Needle, 23Gx1” Each 0003AB Needle, 25Gx1” Each 0003AC Needle, 25Gx5/8” Each 0004 Syringe, 3ml, FDA approved, Safety Engineered, Luer-Lock

Each TBD

0005 Isopropyl Alcohol Impregnated Prep Pads, Sterile, individually sealed,small

Each TBD

0006 Integrated Needle/Syringe TBD

Unit, FDA approved, conventional

0006AA 3mlsyringe/23Gx1” Needle, Conventional

Each

0006AB 3mlsyringe/25Gx1” Needle, Conventional

Each

0007 Report – manufacturing/production schedule

Each Not

0011 Product Exchange Each 0012 Disposal Each 0013 Reports Each Not

Option Year #3 Item # Supply or Service Unit Unit Price Extended

Price 0001 Integrated Needle/Syringe

0002 Integrated Needle/Syringe

Lock

Each

0003AA Needle, 23Gx1” Each 0003AB Needle, 25Gx1” Each 0003AC Needle, 25Gx5/8” Each 0004 Syringe, 3ml, FDA approved, Safety Engineered, Luer- Lock

Each

0005 Isopropyl Alcohol Impregnated Prep Pads, Sterile, individually sealed, small

Each

0006 Integrated Needle/Syringe conventional 0006AA 3mlsyringe/23Gx1” Needle, Conventional Each

0006AB 3mlsyringe/25Gx1” Needle, Conventional

Each

0007 Report – manufacturing/production schedule

Each Not

0011 Product Exchange Each 0012 Disposal Each 0013 Reports Each Not

SECTION B SUPPLIES OR SERVICES AND PRICES/COSTS

B.3 Contract Type – Indefinite-Delivery Indefinite Quantity

This is an Indefinite Delivery Indefinite Quantity (IDIQ) contract for the acquisition of ancillary materials in support of pandemic influenza preparedness and response. During the ordering period of the contract, contracting officers assigned to the office in Block 6 of the SF-26 (Rev. 4/2008) may order, and the Offeror shall provide, supplies and services at the unit price listed below.

B.3.1 Delivery Order and Task Order Type. Delivery orders and task orders issued under this contract will be firm-fixed price.

B.3.2 Implementation of Limitation of Funds. Pursuant to the clause FAR 52.232-22 in

Section I, entitled “Limitation of Funds”, the total amount available for payment and allotted to this contract (s) for CLIN 0001 is $____________

B..3. Minimum and Maximum Quantity

The total scope of the technical tasks for which orders may be issued is set forth in Section C – State of Work. The maximum dollar amount the Government may order under this contract is TBD. The minimum amount guaranteed is $10,000 dollars.

B.4 Advance Understandings

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

HHS may assign a priority rating to any contract awarded under this solicitation. The Contracting Officer may unilaterally modify task order(s) to add FAR Clause 52.211-15, Defense Priority and Allocation Requirements (Sep 1990) and assign a Health and Human Services priority rating under Defense Priorities and Systems Regulation (15

CFR 700).

B.5 Multiple Award Ordering

Under Indefinite Quantity clause, orders will be issued to all contractors awarded a contract under this solicitation. All contractors may receive orders for CLINs 0001 up to the minimum guaranteed amount. Additional quantities may be ordered upon the Government’s need and contractor’s ability to produce the requirement. The Government reserves the right to make multiple awards.

SECTION C DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

C.1 Background

In the last century, four human influenza pandemics have occurred, with the most recent the 2009 H1N1 influenza pandemic. Fortunately, the 2009 H1N1 influenza pandemic produced only mild illness and had a low transmissibility, yet a human influenza pandemic continues to be a public health concern, for the United States and the World. Currently, the scientific community is uncertain which influenza variant will cause the next pandemic, but a future severe influenza pandemic has been estimated would cause over 60 million deaths worldwide.

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

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

The 2009 H1N1 influenza pandemic demonstrated the criticality of having active contracts with manufacturers to respond to an influenza pandemic event. In 2009, the Federal Government rapidly modified existing stockpile contracts and issued task orders to manufacturers for producing millions of doses influenza vaccines. However, similar capabilities for needle and syringe units to accompany vaccines did not exist. In 2009, the Federal Government had an urgent and compelling need for ancillary materials and issued contracts to quickly manufacture needle and syringe units to meet the vaccination requirements of the American people.

Since the 2009 H1N1 influenza pandemic, significant advances have been made to improve the domestic influenza surge capacity with, among other things, the introduction of the first FDA licensed cell-based influenza vaccine (Flu-celvax) in November, 2012 and the first FDA licensed recombinant-based influenza vaccine (FluBlOk) in January, 2013; both firsts in influenza vaccine technology in fifty years. These technologies significantly improved national preparedness but they also placed added pressure on ancillary manufacturers to keep pace.

The objective is to place active contracts with needle and syringe manufacturers to provide continuous supply coverage in order to acquire sufficient inventory and guaranteed access for up to 600 million vaccine delivery devices within six months of a declared public health emergency assuming a two dose regimen spaced 21 – 28 days between the 1st and 2nd vaccinations.

C.2 Scope of Work:

The USG is seeking to acquire needles, syringes, alcohol swaps and logistics services to support a pandemic influenza campaign. 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 to make available to the USG the following products and services suitable for supporting a pandemic influenza vaccination campaign:

C.2.1 Products:

CLIN 0001: Manufacture and make available for purchase up to 512 million FDA approved integrated needle and syringe combination units of the following sizes:

• 0001AA: Needle/Syringe combination unit, 3ml syringe, 23Gx1” needle, safety engineered. The unit for this item will be each.

• 0001AB: Needle/Syringe combination unit, 3ml syringe, 25Gx1” needle, safety engineered. The unit for this item will be each.

CLIN0002: Manufacture and make available for purchase up to 50 million FDA approved Needle/Syringe combination unit, 5ml or 6ml syringe, 20Gx1.5” needle, safety engineered. The unit for this item will be each.

CLIN 0003: Manufacture and make available for purchase up to 88 million FDA approved needles of the following sizes:

• 0003AA: Needle, 23Gx1”, luer lock, safety engineered. The unit for this item will be each.

• 0003AB: Needle, 25Gx1”, luer lock, safety engineered. The unit for this item will be each.

• 0003AC: Needle, 25Gx5/8”, luer lock, safety engineered. The unit for this item will be each.

CLIN 0004: Manufacture and make available for purchase up to 88 million FDA approved 3ml Syringes, luer lock, safety engineered. The unit for this item will be each.

CLIN 0005: Manufacture and make available for purchase up to 600 million Isopropyl Alcohol Impregnated Prep Pads, sterile, individually sealed, small. The unit for this item will be each.

Note: Manufacturers who manufacture needle and syringe units but do not manufacture this product do not need to respond to this CLIN.

CLIN 0006 Manufacture and make available for purchase up to 300 million FDA approved integrated needle and syringe combination units, conventional:

• 0006AA: Needle/Syringe combination unit, 3ml syringe, 23Gx1” needle, conventional. The unit for this item will be each.

• 0006AB: Needle/Syringe combination unit, 3ml syringe, 25Gx1” needle, conventional. The unit for this item will be each.

CLIN 0007: Provide a manufacturing/production schedule (forecast) representative of the surge capacity that can be made available to the USG for pandemic planning purposes.

• Run the manufacturing/production schedule out for twelve months for all products in CLINs 0001-0006.

• List each product corresponding to the CLIN. At a minimum, identify the Stock Keeping Unit, Item description, Quantity and Shipping location.

• Distinguish in this report the manufacturing/production quantities used to meet current health care demands and the delta that could be made available to surge production for an influenza pandemic event.

CLIN 0008: Upon request, provide a delivery schedule of the products that will be made available to the USG for pandemic Influenza response.

• Run the delivery schedule out by nine months for all products.

• Group the schedule by CLINs 0001-0006. List each product corresponding to the

CLIN. At a minimum, identify the Stock Keeping Unit, Item description, Quantity and Shipping location.

C.2.2 Services:

CLIN 0009: Store, rotate, replenish and manage USG purchased products (CLINs 0001-0006) as vendor management inventory.

• Store USG purchased products in contractor owned/contractor operated distribution facilities as vendor managed inventories (VMI). All VMI will be managed on a ‘First- In, First-Out’ basis.

• Manage USG purchased products in compliance with the Federal Acquisition Regulation and the Code of Federal Regulation, Title 21, Part 211, Good Manufacturing Practices,

• Rotate USG purchased products during seasonal influenza campaigns.

• Replenish USG purchased products that have been rotated within one month of being used to support seasonal campaign requirements or other customer demands.

CLIN 0010: Package, handle, and ship USG purchased products (CLIN 0001-0006) from contractor owned/contractor operated distribution facilities to USG designated domestic receiving locations. Receiving locations and Points of Contact information will be provided in task orders. For planning purposes, the USG may elect to identify up to ten (10) receiving locations in the following continental geographic regions; three (3) in the Northeast, two (2) in the South Central Midwest, two (2) in the North Central Midwest, and three (3) in the west region. The contractor shall include all costs and expenses for transit, delivery and insurance of USG product.

CLIN 00011: Exchange USG purchased products (CLINs 0001-0006) for similar products where market demands indicate a change in user preference for other drug device products.

CLIN 00012: Dispose of expired, adulterated or damaged USG products (CLIN 0001-0006) as directed by the USG. The contractor shall dispose of product following any federal, state, local regulation for the appropriate waste category and provide documentation on the completed disposal activity.

CLIN 0013: Reporting and Inventory Requirements. The Contractor shall submit inventory reports, shipment reports, production schedules, forecast reports, monthly progress reports, executive summaries, and ad hoc reports as described in detail in section C.4. ‘Reporting Requirements and Deliverables.’

C.3 Additional Requirements:

C.3.1 The contractor shall be required to communicate and provide electronic data to the

BARDA Tracking Tool. The BARDA Tracking Tool is a business intelligence capability being implemented in 2013 to acquire in near real-time manufacturing and supply chain data for data visualization, modeling, reporting and decision support purposes. BARDA will provide technical specifications to the contractor for sending electronic data following contract award.

C.3.2. The contractor must be e-commerce capable and have demonstrated capabilities to process electronic data interchange information in ANSI X-12 version 4010 formats for Sales Orders (EDI 850), Product activity (EDI 852), and Advanced Shipping Notice (EDI 856).

C.4 Reporting Requirements and Deliverables

The contractor shall submit to the Contracting Officer and the Contracting Officer’s Representative (COR) the following reports. Identify and mark all confidential or proprietary information in the reports accordingly.

C.4.1. Provide a monthly inventory report for all USG purchased products. At a minimum, include the following in this report: Stock Keeping Unit, Lot #, Quantity, Expiration Date, Location and Product Activity Information. This report will be delivered in a Microsoft Excel spreadsheet format until the data exchange environment is established with the BARDA Tracking Tool.

C.4.2 Upon request, in preparation for and/or in response to an influenza pandemic event, provide a daily supply report documenting product activity of USG purchased products from the contractor’s distribution center location to the USG’s directed receiving location. This information is generally related to EDI 850, 856, and 852 transaction sets.

This report will be delivered in a Microsoft Excel spreadsheet format until the data exchange environment can be established with the BARDA Tracking Tool.

C.4.3 Provide electronic copies of shipment and delivery activities, e.g., bills of lading and packing slips for CLIN 0009 whenever USG purchased product is shipped to a USG directed receiving location.

C.4.4. Provide an expiring items forecast report for USG purchased product within six months of expiration on a running quarterly basis for inventory that cannot be rotated with current demands. Provide a negative report if no issues are projected.

C.4.5. Provide an annual sales forecast for influenza drug delivery devices; the purpose of which is to assist with synchronizing standardization activities with the CDC, managing projected inventory levels and to inform the phasing in and transition of product lines.

C.4.6 Provide a one-time product information report. At a minimum, include the following:

o Product name, SKU, and features o Training literature (PDF and web links – if any) o Shipping and handling information to include:

Packaging description by package level (EA, SP, Case) Shipping conditions Shelf life Product Dimension – width, height, length and weight Transportation planning information – quantity per pallet, cases per pallet

C.4.7. Provide a one-time Key Personnel listing. At a minimum, identify and provide contact information and addresses for key personnel at corporate and distribution center locations based on roles:

o Corporate: Account Manager, Project Manager, Senior Supply Chain or Materials Manager, o Distribution Center: Facility Manager, Operations Manager

C.4.8. Upon request, conduct frequent teleconferences with the COR during influenza pandemic events. These calls may be daily, weekly, or monthly subject to the circumstances of the event.

C.4.9. Provide a monthly administrative report. The executive summary shall highlight the activities of the month, relevant issues, risk mitigation, concerns, decisions or other actions of record.

• Final Report. By the expiration of the contract, the contractor shall submit a comprehensive report that shall detail, document, and summarize the results of the entire contract work.

SECTION D PACKAGING AND MARKING

D.1 Delivery of Reports

Unless otherwise specified by the Contracting Officer, delivery of weekly reports, monthly reports and invoices under this contract, shall be made by e-mail and two copies by first class mail. One shall be address to the Contracting Officer and the other copy to the Contracting Officer’s Representative.

D.2 Packaging of Product

D.2.1 As required, packaging of medical devices and samples shall be consistent with the FDA-approved labeling and packaging at the time of processing.

D.2.2 Packaging shall be consistent with standard packaging for this product. Packaging shall be designed to promote quality during long-term controlled storage.

Unless otherwise specified by the Contracting Officer delivery of reports to be furnished to the Government under the resultant contract (including invoices), shall be addressed as follows:

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

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

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

SECTION E INSPECTION AND ACCEPTANCE

E.1 52.252-2 Clauses Incorporated by Reference

CLAUSE TITLE DATE

52.246-1 Contractor Inspection Requirements Apr-84 52.246-2 Inspection of Supplies (Fixed Price) Aug-96 52.246-16 Responsibility of Supplies Apr-84

E.2 Inspection and Acceptance

(a) Inspection and acceptance of the articles, services or documentation called for herein shall be accomplished by the Contracting Officer, or his duly authorized representative (who for the purposes of this contract shall be the COR) at the destination of the articles, services or documentation.

SECTION F DELIVERIES OF PERFORMANCE

CLAUSE TITLE DATE

52.211-17 Delivery of Excess Quantities Sept-89 52.242-15 Stop Work Order Aug-89 52.242-15 Stop-Work Order, Alternate I Apr-84 52.242-17 Government Delay of Work Apr-84 52.247-34 F.O.B. Destination Nov-91

F.1 Period of Performance

The base period of contract performance of this contract is anticipated for one year. If the Government excersises its option(s) pursuant to the Option Provision Article in Section H of this contract, the period of performance will be increased as listed below:

Option Option Period Option 1 Twelve(12) Months (Year 2) Option 2 Twelve(12) Months (Year 3) Option 3 Twelve(12) Months (Year 4)

F.2 Place and Method of Delivery

The delivery of the ancillary supplies shall be F.O.B. Destination.

The place of delivery shall be provided to the Contractor no less than 90 days prior to shipping.

F.3 Reporting Requirements.

F.3.1 Monthly Teleconferences: The Contractor shall participate in monthly teleconferences with USG to discuss the performance of the contract. The Contractor shall keep meeting minutes and forward a finalized copy to the Contracting Officer and COR for approval within three (3) business days after each teleconference, or as otherwise authorized by the Contracting Officer.

F.3.2 Weekly / Daily Teleconferences: Upon request, in preparation for or in a response to an

Influenza Pandemic event, the Contractor shall participate in weekly and/or daily teleconferences with USG to discuss the performance of the contract. The purpose of these meetings will be oriented on the coordination efforts required to ensure the uninterrupted flow of material.

ITEM DELIVERABLE QUANTITY DUE DATE

1. Monthly Inventory

Report – Excel Original – CO One electronic Copy – COR

NLT the 15th of the month for the

Spreadsheet One electronic Copy – CO preceding month

2. Daily Supply Report –

Excel Spreadsheet Original – CO One electronic Copy – COR Data Exchange with BARDA Tracking Tool

Daily upon direction of CO until cancelled

3. Shipping Documentation

Original – CO One electronic copy – COR

Upon shipment

4. Expiring Items Report Original – CO One electronic copy – COR

NLT the 15th of Month on a Quarterly Basis (Jan,Apr,Jul,Sep)

5 Product Information Report

Original – CO One electronic copy – COR

Once per Year within 15 days of contract award

6. Key Personnel Listing Original – CO One electronic copy – COR

Once per Year within 15 days of contract award – update as required.

7 Monthly Executive Summary

Original – CO One electronic Copy – COR One electronic Copy – CO

NLT the 15th of the month for the preceding month

8. Final Report Original – CO One electronic copy – COR

Draft Final Report due in both hard copy and an electronic copy on/before the completion date of the contract. Final report due 30 days after Government comments.

F.4 Point 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 a public health emergency.

F.5 Sample Inspection

At the discretion of the USG and independent of testing conducted by the contractor, the USG reserves the right to conduct site visits and collect samples of products held and stored by the Contractor.

F.6 Disposition of the Inventory

Upon expiration or termination (including partial termination) of this contract, the USG may effect final distribution of any syringes and supplies produced on this contract, and remaining in storage at the Contractor’s facility by any one or combination of the following methods.

a. The USG may elect to direct the Contractor to ship to a consignee(s) designed by the USG, all syringes and supplies remaining in storage at the Contractor’s facility

b. The USG may offer syringes to be repurchased by the Contractor at the original purchase price

c. The USG may request disposal of unshipped syringes and supplies stored at the Contractor’s facility.

d. The Offeror will be responsible for the management of inventory.

SECTION G CONTRACT ADMINISTRATION DATA

G.1 Designation of Government Contracting Officer and Contract Specialist

Linda D. Luczak, Contracting Officer and Tasha McMillian, Contract Specialist, Office of Aquisitions Management Contracts & Grants (AMCG), have been assigned to administer the contractual aspects of this contract.

The Contracting Officer 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.

The Contracting Officer 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 any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

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

Office of Aquisitions Management Contracts & Grants (AMCG) Assistant Secretary for Preparedness and Response (ASPR) Department of Health and Human Services 330 Independence Ave, SW, RM G640 Washington, DC 20201

Telephone Number: 202-260-0271 (Linda Luczak) Telephone Number: 202-205-1502 (Tasha McMillian) E-mail Address: linda.luczak @hhs.gov E-mail Address: tasha.mcmillian@hhs.gov

G.2 Designation of the Contracting Officer’s Representative

(a) The individual(s) named below is hereby designated as the Contracting Officer’s Representative (COR). If an alternate COR is listed below, that person will serve in the COR’s stead when the COR is unavailable. The COR is responsible for the technical administration of this contract, [in accordance with the provisions of the clause included herein entitled, "Technical Direction” and the COR letter of delegation."] mailto:kyle.roberts@hhs.gov� mailto:tasha.mcmillian@hhs.gov�

NAME ADDRESS

TBD Assistant Secretary for Preparedness and Response

Biomedical Advanced Research Development Authority

Department of Health and Human Services 330 Independence Ave, SW, RM G640 Washington, DC 20201

(b) The COR, or his/her authorized representative, shall be responsible for coordinating with the contractor the technical aspects of the contract. The COR is not authorized to make any changes, which affect the contract amount, terms or conditions. The contracting officer is the only person with the 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 any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

G.3 Payment by Electronic Funds Transfer (Jan 2000)

(a) 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 Transfer-Central Contractor Registration, in Section I, requires the contractor to designate in writing a financial institution for receipt of electronic funds transfer payment

(b) The Contractor shall make the designation by submitting the form titled “ACH Vendor/Miscellaneous Payment Enrollment Form: to the address indicated below.

Note: the form is either attached to this contract (see Section J, List of Attachments) or may be obtained by contacting the Contracting Officer.

(c) In cases where the contractor has previously provided such designation, i.e., pursuant to a prior contract/order, and been enrolled in the program, the form is not required.

G.4 Invoice Submission

(a) The Contractor shall submit invoices to the Contracting Officer.

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

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

Office of Aquisitions Management Contracts & Grants Assistant Secretary for Preparedness and Response Department of Health and Human Services

330 Independence Ave, SW, RM G640 Washington, DC 20201 Attn: Linda Luczak

Submit an electronic copy to the following email addresses:

Tasha.McMillian@hhs.gov

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 and delivery/task order (if applicable)

(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 if different than number 1 above.

(12) Any additional backup information required to justify the invoice.

G.5 Subcontracting Program Reports (May 1998)

(a) The Contractor shall submit the reports listed below in accordance with the instructions and with the time periods specified on the report forms:

(1) Standard Form 294, Subcontracting Report for Individual Contracts.

(2) Standard Form 295, Summary Subcontract Report.

(b) In addition to the reporting information specified on the report forms, the Contractor shall provide, in the “Remarks” block on each Standard Form 294 submitted, a narrative of the progress made in fulfilling the small business subcontracting goals contained in its approved plan.

(c) The Contractor shall report to the Contracting Officer any difficulties encountered in achieving the goals and shall describe the action being taken to overcome the difficulties.

(End of Clause)

G.6 Evaluation of Contractor Performance (Jan 2000)

(a) Purpose mailto:Tasha.McMillian@hhs.gov�

In accordance with FAR 42.1502, the Contractor's performance will be periodically evaluated by the Government, in order to provide current information for source selection purposes. These evaluations will therefore be marked "Source Selection Information."

(b) Performance Evaluation Period

The Contractor's performance will be evaluated at least annually.

(c) Evaluators

The performance evaluation will be completed jointly by the Project officer and the Contracting officer.

(d) Performance Evaluation Factors

The contractor's performance will be evaluated in accordance with the attachment listed in Section J titled Performance Evaluation Report.

(e) Contractor Review

A copy of the evaluation will be provided to the contractor as soon as practicable after completion of the evaluation. The contractor shall submit comments, rebutting statements, or additional information to the Contracting Officer within 30 calendar days after receipt of the evaluation.

(f) Resolving Disagreements Between the Government and the Contractor

Disagreements between the parties regarding the evaluation will be reviewed at a level above the Contracting Officer. The ultimate conclusion on the performance evaluation is a decision of the contracting agency. Copies of the evaluation, contractor's response, and review comments, if any, will be retained as part of the evaluation.

(g) Release of Contractor Performance Evaluation Information

The completed evaluation will not be released to other than Government personnel and the contractor whose performance is being evaluated. Disclosure of such information could cause harm both to the commercial interest of the Government and to the competitive position of the contractor being evaluated as well as impede the efficiency of Government operations.

(h) Source Selection Information

Departments and agencies may share past performance information with other Government departments and agencies when requested to support future award decisions. The information may be provided through interview and/or by sending the evaluation and comment document to the requesting source selection official.

(i) Retention Period

The agency will retain past performance information for a maximum period of three years after completion of contract performance for the purpose of providing source selection information for future contract awards.

G.7 Contract Communications/Correspondence (Jul 1999)

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.

(End of Clause)

G.8 Ordering

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule.

(b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control.

(c) If mailed, a delivery order or task order is considered "issued" when the Government deposits the order in the mail. Orders may be issued orally, by facsimile, or by electronic commerce methods only if authorized in the Schedule.

(End of clause)

G.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 48 hour written notice in advance to the Contracting Officer.

G.10 Press Releases

1. Pursuant to Public Law(s) cited in paragraph (2), below, 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:

the percentage of the total costs of the program or project which will be financed with Federal money; the dollar amount of Federal funds for the project or program; and the percentage and dollar amount of the total costs of the project or program that will be financed by nongovernmental sources.

2. Public Law and Section No. Fiscal Year Period Covered

G.11 Reporting Matters Involving Fraud, Waste, and Abuse

Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in BARDA funded programs is encouraged to report such matters to 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 e-mail address is htips@os.dhhs.gov and the mailing address is:

Office of Inspector General Department of Health and Human Services

TIPS HOTLINE

P. O. Box 23489 Washington, DC 20026 mailto:htips@os.dhhs.gov�

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 Department of Health and Human Service's 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 (and their subcontractors) 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 and FAR Clause 52.203-12.

In addition, the current Department of Health and Human Services Appropriations Act provides that no part of any appropriation contained in this Act shall be used, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support, or defeat legislation pending before the Congress, or any State or Local legislature except in presentation to the Congress, or any State or Local legislative body itself.

The current Department of Health and Human Services Appropriations Act also provides that no part of any appropriation contained in this Act shall be used to pay the salary or expenses of any contract or grant recipient, or agent acting for such recipient, related to any activity designed to influence legislation or appropriations pending before the Congress, or any State or Local legislature.

H.2 Dissemination of Information

No information related to data obtained under this contract shall be released or publicized without the prior written consent of the Contracting Officer, which approval shall not be unreasonably withheld, conditioned, or delayed; provided, however, that no such consent is required to comply with any law, rule, regulation, court ruling or similar order; for submission to any government entity’ for submission to any securities exchange on which the Contractor’s (or its parent corporation’s) securities may be listed for trading; or to third parties relating to securing, seeking, establishing or maintaining regulatory or other legal approvals or compliance, financing and capital raising activities, or mergers, acquisitions, or other business transactions.

H.3 Identification and Disposition of Data

The Contractor will be required to provide certain data generated under this contract to the Department of Health and Human Services (HHS). HHS reserves the right to review any other data determined by HHS to be relevant to this contract. The contractor shall keep copies of all data required by the Food and Drug Administration (FDA) relevant to this contract for the time specified by the FDA.

H.4 Year 2000 Compliance

Unless elsewhere exempted, information technology (if any) to be acquired under this contract/purchase order, which will be required to perform date/time processing involving dates subsequent to December 31, 1999, shall be Year 2000 compliant as defined in Federal Acquisition Regulation Part 39.002.

(End of Clause)

H.5 Representations, Certifications and Other Statements of Contractors

The Representations, Certifications and Other Statements of Contractors submitted by (contractor) are hereby incorporated by reference, with the same force and effect as if they were given in full text.

(End of Clause)

H.6 Option Provision

Unless the Government exercises its option pursuant to the Option Clause set forth in ARTICLE I.3., the contract will consist only of the Base Period of the Statement of Work as defined in Sections C and F of the contract. Pursuant to FAR Clause 52.217-9, Option to Extend the Term of the Contract set forth in ARTICLE I.3. of this contract, the governmentmay, by unilateral contract modification, require the Contractor to perform additional options set forth in the Statement of Work and also defined in Sections C and F of the contract. If the Government exercises this option, notice must be given at least 60 days prior to the expiration date of the base period of the contract or any subsequent options and the price of the contract will be increased as set forth in the OPTION PRICES Article in SECTION B of this contract.

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 address(es):

https://www.acquisition.gov/far http://farsite.hill.af.mil/vffar1.htm a.

I. ARTICLE I.1. GENERAL CLAUSES FOR A NEGOTIATED FIXED-PRICE

SUPPLY CONTRACT

FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1)

CLAUSES:

This contract incorporates the following 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 as follows: FAR Clauses at: https://www.acquisition.gov/far/ . HHSAR Clauses at:

http://www.hhs.gov/policies/hhsar/subpart352.html .

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

FAR

CLAUSE NO.

DATE TITLE

52.202-1

Jan 2012 Definitions 52.203-3 Apr 1984 Gratuities 52.203-5 Apr 1984 Covenant Against Contingent Fees 52.203-6 Sep 2006 Restrictions on Subcontractor Sales to the Government 52.203-7 Oct 2010 Anti-Kickback Procedures 52.203-8 Jan 1997 Cancellation, Rescission, and Recovery of Funds for Illegal or

Improper Activity 52.203-10 Jan 1997 Price or Fee Adjustment for Illegal or Improper Activity 52.203-12 Oct 2010 Limitation on Payments to Influence Certain Federal

Transactions 52.204-4 May 2011 Printed or Copied Double-Sided on Postconsumer Fiber

Content Paper 52.204-10 Aug 2012 Reporting Executive Compensation and First-Tier Subcontract

Awards 52.204-13 Dec 2012 Central Contractor Registration Maintenance 52.209-6 Dec 2010 Protecting the Government's Interests When Subcontracting

With Contractors Debarred, Suspended, or Proposed for Debarment

52.211-5 Aug 2000 Material Requirements http://farsite.hill.af.mil/vffar1.htm� https://www.acquisition.gov/far/� http://www.hhs.gov/policies/hhsar/subpart352.html� http://www.hhs.gov/policies/hhsar/subpart352.html�

52.215-2

Oct 2010 Audit and Records - Negotiation 52.215-8 Oct 1997 Order of Precedence - Uniform Contract Format 52.215-10 Aug 2011 Price Reduction for Defective Certified Cost or Pricing Data 52.215-12 Oct 2010 Subcontractor Cost or Pricing Data 52.215-14 Oct 2010 Integrity of Unit Prices 52.215-15 Oct 2010 Pension Adjustments and Asset Reversions 52.215-18 Jul 2005 Reversion or Adjustment of Plans for Post-Retirement Benefits

(PRB) other than Pensions 52.215-19 Oct 1997 Notification of Ownership Changes 52.215-21 Oct 2010 Requirements for Certified Cost or Pricing Data and Data Other

Than Certified Cost or Pricing Data - Modifications 52.219-8 Jan 2011 Utilization of Small Business Concerns 52.219-9 Jan 2011 Small Business Subcontracting Plan 52.219-16 Jan 1999 Liquidated Damages - Subcontracting Plan 52.222-19 Apr 2012 Child Labor--Cooperation with Authorities and Remedies 52.222-20 Oct 2010 Walsh-Healey Public Contracts Act 52.222-21 Feb 1999 Prohibition of Segregated Facilities 52.222-26 Mar 2007 Equal Opportunity 52.222-35 Sep 2010 Equal Opportunity for Veterans 52.222-36 Oct 2010 Affirmative Action for Workers with Disabilities 52.222-37 Sep 2010 Employment Reports on Veterans 52.222-40 Dec 2010 Notification of Employee Rights Under the National Labor

Relations Act 52.222-50 Feb 2009 Combating Trafficking in Persons 52.222-54 Jul 2012 Employment Eligibility Verification 52.223-6 May 2001 Drug-Free Workplace 52.223-18 Aug 2011 Encouraging Contractor Policies to Ban Text Messaging While

Driving 52.225-1 Feb 2009 Buy American Act - Supplies 52.225-13 Jun 2008 Restrictions on Certain Foreign Purchases 52.227-1 Dec 2007 Authorization and Consent 52.227-2 Dec 2007 Notice and Assistance Regarding Patent and Copyright

Infringement 52.229-3 Feb 2013 Federal, State and Local Taxes 52.232-1 Apr 1984 Payments 52.232-8 Feb 2002 Discounts for Prompt Payment 52.232-9 Apr 1984 Limitation on Withholding of Payments 52.232-11 Apr 1984 Extras 52.232-17 Oct 2010 Interest 52.232-23 Jan 1986 Assignment of Claims 52.232-25 Oct 2008 Prompt Payment 52.232-33 Oct 2003 Payment by Electronic Funds Transfer--Central Contractor

Registration 52.233-1 Jul 2002 Disputes

52.233-3

Aug 1996 Protest After Award 52.233-4 Oct 2004 Applicable Law for Breach of Contract Claim 52.242-13 Jul 1995 Bankruptcy 52.243-1 Aug 1987 Changes - Fixed-Price 52.244-6 Dec 2010 Subcontracts for Commercial Items 52.249-2 Apr 2012 Termination for the Convenience of the Government (Fixed-

Price) 52.249-8 Apr 1984 Default (Fixed-Price Supply and Service) 52.253-1 Jan 1991 Computer Generated Forms

b. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION

(HHSAR) (48 CFR CHAPTER 3) CLAUSES:

HHSAR

352.202-1

Jan 2006 Definitions 352.203-70 Mar 2012 Anti-Lobbying 352.222-70 Jan 2010 Contractor Cooperation in Equal Employment Opportunity

Investigations 352.227-70 Jan 2006 Publications and Publicity 352.231-71 Jan 2001 Pricing of Adjustments 352.242-70 Jan 2006 Key Personnel 352.242-73 Jan 2006 Withholding of Contract Payments

I.2 ADDITIONAL FAR CLAUSES INCORPORATED IN FULL TEXT

This contract incorporates the following clauses in full text.

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

FAR 52.209-9

UPDATES OF PUBLICLY AVAILABLE INFORMATION REGARDING RESPONSIBILITY MATTERS (FEB

2012)

(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 Central Contractor Registration database via https://www.acquisition.gov.

(b) As required by section 3010 of the Supplemental Appropriations Act, 2010 (Pub. L. 111- 212), all information posted in FAPIIS on or after April 15, 2011, except past performance reviews, will be publicly available. FAPIIS consists of two segments— https://www.acquisition.gov/�

(1) The non-public segment, into which Government officials and the Contractor post information, which can only be viewed by—

(i) Government personnel and authorized users performing business on behalf of the Government; or

(ii) The Contractor, when viewing data on itself; and

(2) The publicly-available segment, to which all data in the non-public segment of FAPIIS is automatically transferred after a waiting period of 14 calendar days, except for—

(i) Past performance reviews required by subpart 42.15;

(ii) Information that was entered prior to April 15, 2011; or

(iii) Information that is withdrawn during the 14-calendar-day waiting period by the Government official who posted it in accordance with paragraph (c)(1) of this clause.

(c) The Contractor will receive notification when the Government posts new information to the Contractor’s record.

(1) If the Contractor asserts in writing within 7 calendar days, to the Government official who posted the information, that some of the information posted to the non-public segment of FAPIIS is covered by a disclosure exemption under the Freedom of Information Act, the Government official who posted the information must within 7 calendar days remove the posting from FAPIIS and resolve the issue in accordance with agency Freedom of Information procedures, prior to reposting the releasable information.

The contractor must cite 52.209-9 and request removal within 7 calendar days of the posting to FAPIIS.

(2) The Contractor will also have an opportunity to post comments regarding information that has been posted by the Government. The comments will be retained as long as the associated information is retained, i.e., for a total period of 6 years. Contractor comments will remain a part of the record unless the Contractor revises them.

(3) As required by section 3010 of Pub. L. 111-212, all information posted in FAPIIS on or after April 15,…