SNS_Antiviral_RFP_final.pdf

PAGES

15A. NAME

AND

ADDRESS

OF

OFFEROR

SEC. PAGE(S) SEC. PAGE(S)

(Date) (Hour)

CALENDAR DAYS

14. ACKNOWLEDGMENT OF AMENDMENTS

(The Offeror acknowledges receipt of amend-ments to the SOLICITATION for Offerors and related documents numbered and dated:

(Type or Print)

PAGES

(Date) (Hour)

SEC. PAGE(S) SEC. PAGE(S)

CALENDAR DAYS

14. ACKNOWLEDGMENT OF AMENDMENTS

(The Offeror acknowledges receipt of amend-ments to the SOLICITATION for Offerors and related documents numbered and dated:

15A. NAME

AND

ADDRESS

OF

OFFEROR

(Type or Print)

AUTHORIZED FOR LOCAL REPRODUCTION STANDARD FORM 33 (REV. 9-97)

PREVIOUS EDITION IS UNUSABLE Prescribed by GSA

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

UNDER DPAS (15 CFR 700)

RATING

PAGE OF

1 93

2. CONTRACT NO.

N/A

3. SOLICITATION NO.

19-100-SOL-00008

4. TYPE OF SOLICITATION

SEALED BID (IFB)

X NEGOTIATED(RFP)

5. DATE ISSUED

01/18/2019

6. REQUISITION/PURCHASE

NO.

N/A

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

HHS/OS/ASPR/ORM

O’Neill House Office Building 200 C Street SW Washington, DC 20015

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

SOLICITATION

9. Sealed offers in original and 0 copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if handcarried, in the depository located in See Section L for Instructions until 2:00PM ET 02/25/2019

CAUTION -- LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1.

All offers are subject to all terms and conditions contained in this solicitation.

10. FOR INFORMATION

CALL:

A. NAME

Tasha McMillian

a. TELEPHONE (NO COLLECT CALLS)

202-205-1502

b. E-MAIL ADDRESS

Tasha.McMillian@hhs.gov

11. TABLE OF CONTENTS

((x) DESCRIPTION (x) DESCRIPTION

PART I – THE SCHEDULE PART II – CONTRACT CLAUSES

X A SOLICITATION/CONTRACT FORM 01 X I CONTRACT CLAUSES 26

X B SUPPLIES OR SERVICES AND PRICES/COSTS 03 PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

X C DESCRIPTION/SPECS./WORK STATEMENT 07 X J LIST OF ATTACHMENTS 38

X D PACKAGING AND MARKING 12 PART IV – REPRESENTATIONS AND INSTRUCTIONS

X E INSPECTION AND ACCEPTANCE 13 REPRESENTATIONS, CERTIFICATIONS, AND

X F DELIVERIES OR PERFORMANCE 14 X OTHER STATEMENTS OF CONTRACTORS 39

X G CONTRACT ADMINISTRATION DATA 18 X L INSTRS., CONDS., AND NOTICES TO

CONTRACTORS

X H SPECIAL CONTRACT REQUIREMENTS 24 X M EVALUATION FACTORS FOR AWARD 65

OFFER (Must be fully completed by Contractor)

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

12. In compliance with the above, the undersigned agrees, if this offer is accepted within ___ 120__calendar days (60 calendar days unless a different period is inserted by the Contractor) 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

AMENDMENT NO. DATE AMENDMENT NO. DATE

CODE FACILITY 16. NAME AND ADDRESS OF PERSON AUTHORIZED TO SIGN OFFER

15B. TELEPHONE NO.

AREA CODE NUMBER EXT.

15C. CHECK IF REMITTANCE ADDRESS

IS DIFFERENT FROM ABOVE - ENTER

SUCH ADDRESS IN SCHEDULE.

17. SIGNATURE

18. OFFER DATE

AWARD (To be completed by Government)

19. ACCEPTED AS TO ITEMS NUMBERED 20. AMOUNT

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

21. ACCOUNTING AND APPROPRIATION

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

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

(4 copies unless otherwise specified)

ITEM

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

26. NAME OF 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.

FAR (48 CFR) 53.214©

K mailto:Tasha.McMillian@hhs.gov

RFP # 19-100-SOL-00008

NOTE TO OFFERORS

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

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

Potential Contractors must be registered in the System for Award Management (SAM) prior to award of a contract.

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

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

SUBMISSION: An electronic and (one) paper copy of the proposal shall be submitted to Tasha.McMillian@hhs.gov. The paper copy is the official copy for recording timely receipt of proposals however both copies are due no later than February 25, 2019 at

2:00pm EST.

Mail Submission

One original signed full proposal (stamped “original”)

USPS/UPS/FedEx/Courier Contracting Officer – Tasha McMillian

ASPR/ORM (202) 205-1502

Room C1A06 – O’Neil House Office Building Washington, DC 20515

The cutoff date for all questions on the RFP is February 1, 2019 by 2:00 PM EST. All questions shall be submitted via e-mail to Tasha.McMillian@hhs.gov. Responses to the questions will be posted to www.fbo.gov no later than February 8, 2019.

mailto:Tasha.McMilllian@hhs.gov mailto:Tasha.McMillian@hhs.gov http://www.fbo.gov/

SECTION B SUPPLIES OR SERVICES AND PRICES/COSTS

B.1 Description of Supplies or Services

The Government is considering the purchase of Oseltamivir 30 & 75mg and Zanamivir 5mg.

In addition, the DSNS is interested in leveraging the current pharmaceutical supply chain to rapidly dispense antiviral drugs to a targeted population during an influenza pandemic. This will:

1) Assure timely access to antiviral drugs during a pandemic influenza event via normal pharmaceutical distribution/dispensing channels;

2) Increase flexibility, scalability, and accountability of antiviral distribution and dispensing;

and

3) Decrease logistical and other operational burdens on public health.

The government anticipates that at the start of a pandemic event, these medications would be provided to the vendor at time of event or in advance through Vendor Managed Inventory (VMI), who would then incorporate them into a normal pharmaceutical supply chain.

The offeror shall ensure that all distribution of medications provided by the DSNS be conducted through normal U.S. pharmaceutical supply channels. Medication stocks will be provided to patients at pharmacies and other facilities (long term care facilities, hospitals, etc.) per DSNS direction. Product should be provided to the public with no product costs to increase access to needed prescription medications, although dispensing fees may be charged by those dispensing to patients.

It is anticipated that a pandemic influenza event would ultimately overwhelm available stock of antivirals. In the contemplated R-VMI structure, the government would continue to purchase and hold stock of material to meet established goals. The government anticipates that at the start of a pandemic event, these materials would be provided to the vendor who would then insert these into a normal operating supply chain.

B.2 Contract Line Item Numbers (CLINs)

The following Contract Line Item Number (CLIN) descriptions and tables represent a suggested schedule however the vendor is encouraged to provide an alternate CLIN structure that provides the best value to the Government.

Task /Delivery Order Requests (T/DORs) for any of the supplies and 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 IDIQ contract period of performance.

Base Period 1 (12 months from date of contract award)

Item # Supply or Service Unit Unit Price Extended Price

1001 Oseltamivir 30mg Capsules Each To be negotiated

(TBN)

TBN

1002 Oseltamivir 75mg Capsules Each

1003 Zanamivir 5mg Each

1004 Distribution Fee (Optional) Each

Total Estimated Dollar Amount – Base Period 1 (12 Months)

Period 2 (12-24 months from date of award)

Price

2001 Oseltamivir 30mg Capsules Each To be negotiated

(TBN)

TBN

2002 Oseltamivir 75mg Capsules Each

2003 Zanamivir 5mg Each

2004 Distribution Fee (Optional) Each

Period 2 (12 Months)

Period 3 (24-36 months from date of award)

Price

3001 Oseltamivir 30mg Capsules Each To be negotiated

(TBN)

TBN

3002 Oseltamivir 75mg Capsules Each

3003 Zanamivir 5mg Each

3004 Distribution Fee (Optional) Each

Period 3 (12 Months)

Period 4 (36-48 months from date of award)

Price

4001 Oseltamivir 30mg Capsules Each To be negotiated

(TBN)

TBN

4002 Oseltamivir 75mg Capsules Each

4003 Zanamivir 5mg Each

4004 Distribution Fee (Optional) Each

Period 4 (12 Months)

Period 5 (48-60 months from date of award)

Price

5001 Oseltamivir 30mg Capsules Each To be negotiated

(TBN)

TBN

5002 Oseltamivir 75mg Capsules Each

5003 Zanamivir 5mg Each

5004 Distribution Fee (Optional) Each

Period 5 (12 Months)

B.3 Contract Type – Indefinite-Delivery Indefinite Quantity

This is an Indefinite Delivery Indefinite Quantity (IDIQ) contract for the acquisition of influenza antiviral pharmaceuticals and distribution in support of preparedness and response activities.

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 in the IDIQ.

B.3.1 Delivery Order and Task Order Type (T/DOR)

All orders under this contract shall be firm-fixed price (FFP) with a possible exception for dispensing and distributing dependent upon vendor responses.

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) is $TBD.

B.3.3 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 $186 Million dollars. The minimum amount guaranteed is $10,000 dollars.

B.4 Advance Understandings

The Department of Health and Human Services (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 (Apr

2008) and assign a Health and Human Services priority rating under Defense Priorities and Systems Regulation (15 CFR 700).

HHS may require the contractor to collaborate with the Assistance Secretary for Preparedness and Response’s (ASPR) kitting contractor or designated logistics organization in advance of any public health emergency. This collaboration will be necessary to establish lines of communication and proper planning for the timing, shipment and delivery of ancillary products.

B.5 Multiple Award Ordering

Under the Indefinite Quantity clause, orders will be issued to all contractors awarded a contract under this solicitation for the minimum guarantee. The Contracting Officer must provide each awardee a fair opportunity to be considered for each order exceeding $10,000 issued under multiple delivery-order contracts or multiple task-order contracts, except as provided for in paragraph (b)(2). 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 – Statement of Objectives (SOO)

C. 1. Background

The Division of Strategic National Stockpile (DSNS) is responsible for federal stockpiling and deploying pharmaceuticals and medical supplies needed during a public health response.

During a public health emergency, these supplies of medications used to treat or prevent illness may need to be distributed and dispensed to people throughout the country. Currently, distribution and dispensing/administration of pharmaceuticals from the DSNS relies on the public health system (state and local health departments). ASPR/DSNS in collaboration with CDC is looking optimize distribution of SNS medications specifically for an influenza pandemic emergency.

To support pandemic influenza preparedness, DSNS holds a stockpile of select antiviral drugs intended to treat ill individuals who present for care. DSNS antiviral inventory includes zanamivir (trade name: Relenza) and various formulations of oseltamivir (trade name: Tamiflu). During a pandemic influenza emergency, these drugs may be released from the federal stockpile. The DSNS is looking to make the best use of existing methods and systems that operate day-to day to distribute and dispense influenza antiviral drug stockpiles.

C. 2. Objective

The Government is considering the purchase of oseltamivir and zanamivir in the quantities described in Section 7.

In addition, the DSNS is interested in leveraging the current pharmaceutical supply chain to rapidly dispense antiviral drugs to a targeted population during an influenza pandemic. This will:

1) Assure timely access to antiviral drugs during a pandemic influenza event via normal pharmaceutical distribution/dispensing channels;

2) Increase flexibility, scalability, and accountability of antiviral distribution and dispensing; and

3) Decrease logistical and other operational burdens on public health.

The government anticipates that at the start of a pandemic event, these medications would be provided to the vendor at time of event or in advance through Vendor Managed Inventory (VMI), who would then incorporate them into a normal pharmaceutical supply chain.

The offeror shall ensure that all distribution of medications provided by the DSNS be conducted through normal U.S. pharmaceutical supply channels. Medication stocks will be provided to patients at pharmacies and other facilities (long term care facilities, hospitals, etc.) per DSNS direction. Product should be provided to the public with no product costs to increase access to needed prescription medications, although dispensing fees may be charged by those dispensing to patients.

In addition to pandemic preparedness, the government also recognizes the role of influenza antiviral drugs during annual influenza seasons. Since the severity of influenza seasons are unpredictable, antiviral drug demand has also shown to be unpredictable. As such, the government is interested in the ability to assist the commercial market to meet seasonal and early pandemic product needs. In short, the government would hold antiviral drugs in the quantities needed to support pandemic influenza readiness and if commercial shortage of antiviral drugs present, the government would provide product to the vendor for placement in private markets. Replacement product would then be delivered to the government by the vendor at no additional cost. This would allow the vendor to meet the needs of unpredictable influenza outbreaks and prevent product shortfalls. The government would expect that when product is within 12 months of expiry, the offeror will retrieve a specified quantity and simultaneously deliver the same quantity of replacement product. For ease of reference, the government will refer to this model as reverse vendor managed inventory (R-VMI). Several opportunities for improved availability of antiviral drugs exist in this model.

It is anticipated that a pandemic influenza event would ultimately overwhelm available stock of antivirals. In the contemplated R-VMI structure, the government would continue to purchase and hold stock of material to meet established goals. The government anticipates that at the start of a pandemic event, these materials would be provided to the vendor who would then insert these into a normal operating supply chain.

C. 3. Technical Requirements

The offeror may propose alternate solutions that ultimately meet the Government’s objective.

The offeror may propose on one or all requirements.

C. 3.1 R-VMI purchase, storage and return of material

The government is considering the purchase of and/or a Reverse Vendor Managed Inventory (R-VMI) with the ability to purchase oseltamivir and zanamivir as outlined in Section 7. Product delivered shall have a minimum years to expiry as agreed to (Government preference is no less than 6 months from date of manufacture). For a R-VMI, the government will store and manage this product as required to assure it can be rotated back to the vendor within 1 year of its expiry with fresh product replenishment at no additional cost to the government. The government is prepared to accept up to 10% above the purchased quantity and store that at no additional cost.

This product would then be immediately available to the government should an unanticipated requirement emerge (following a unilateral modification funding the option) or, alternatively, be returned to the offeror immediately upon their request with no expectation of replacement.

The offeror may also request the government return product to them if needed. If the government agrees to the return, this product would then be replaced at no additional cost to the government within 30 days of return to the offeror.

The Government currently holds product that has had its shelf life extended; only labeled product with a good-dated shelf life would be given back to the manufacturer to fill in for shortages.

C. 3.2 Product distribution, cost to the customer (paid prescriptions)

In a declared pandemic influenza event, the offeror will assure distribution of material from SNS through normal US pharmaceutical supply channels. Product will be provided to pharmacies and other facilities (long term care, hospitals, etc.) as needed. Individuals presenting a prescription at these locations will pay the normal drug cost associated with the product.

Upon exercise of this task, the government will return product to the offeror as a loan on an agreed upon schedule at up to three locations at the government’s expense. The offeror will then use this product to assure that no product shortage occurs or that product shortage is limited throughout the normal product supply chain to the retail/dispensing facility level. Product loaned may be provided to end users not to exceed normal costs. The offer will be responsible for replenishing product loaned from the government at no cost to the government. In the event CDC issues a formal solicitation, the offeror should propose how long replenishment would take based on product volume required.

In addition, during a pandemic, it is critical that cost is not a barrier to access. As such, the offeror will assure that a process is in place that will allow persons who are unable to pay the cost for the product to still access the product at no charge. The government will not expect that drug provided at no charge be replaced in government stock at no cost to the government.

The government will retain a quantity of the product to distribute through alternate channels (e.g., State health departments) based on the specific event and other factors present at the time this task would be exercised.

C. 3.3 Product distribution, no cost to the consumer

This task will operate as detailed in 3.2 however, no person presenting a prescription would be charged for the product. There should be no cost paid by the consumer for products.

Dispensing fees may be charged by retailers. The government will not expect product replacement at no cost. Product will be provided to the public at retail locations with no product costs to increase access to needed prescription medications.

C. 3.4 Alternate Antivirals

The Government may request the inclusion for distribution of orally administered antiviral medication not listed herein. This may be a result of availability, new guidance, new innovative products, etc. that would ultimately benefit the Government. Should this be needed, a SOW request will be issued and modification to the contract performed at such time.

C. 4. Distribution Requirements

DSNS is seeking capability statements from qualified businesses having the current ability to provide pharmaceuticals to pharmacies (as well as hospitals, long term care facilities and other clinical settings) in every state in the country.

The following shall be detailed in the offeror’s proposal:

4.1 Distribution/Scalability: The government’s need to increase access to inventory may vary during an influenza pandemic response. As such, the vendor is expected to have the ability to execute “select distribution” strategies to decrease or increase targeted locations that received product. This could include sending inventory to pharmacies that fill the most number of prescriptions in a zip code, to select chains/stores, to cover a targeted population radius (example: within 10 mile radius of 85% of the population). The offeror should also have the ability to execute “select distribution” strategies and adjust inventory provided to hospitals and other facilities when needed. The offeror should have the ability to deliver daily including weekends, and must have the ability to deliver expedited shipments if needed with expectation to have a 24 hours a day/7 days a week operation in place.

a) The successful offeror must be able to:

1. Create geo-maps of the above scenarios, making it clear what areas of the country they can serve during a pandemic. Map should clearly depict the pharmacies that the offeror currently serves and create a legend that characterizes each pharmacy as a 1) chain (list chain name) 2) independent pharmacy 3) hospital pharmacy 4) long term care facility, 5) clinic, or 6) other. Map should also include population density in each county based on the 2015 US Census.

2. Adjust distribution within 72 hours of demand changes in consultation with the government

3. Not exceed 24 hours from presentation of a requirement to any pharmacy at established distribution locations for expedited shipments

4. Determine a plan to prevent hoarding/excess ordering of product.

4.2 Replenishment: Expectation is that vendor will have adequate replenishment processes across warehouses to serve pharmacies (and other settings) and should balance inventory to meet peak demands

Expectation: 99% Fill rate from each warehouse to pharmacy.

4.3 Allocation: Orders should be filled based on previous day fill plus X%

Expectation: 99% fill rate from each warehouse to pharmacy.

4.4 Inventory Tracking and Reporting: Ability to accurately track inventory in warehouses and track product deployed to pharmacies. Tracking must be reported to DSNS and CDC.

The successful offeror shall:

1. Manage and track inventory throughout the supply chain including, but not limited to: product available at distribution warehouses and product shipped to other locations with 99% accuracy.

2. Provide bi-daily - twice a day reports on inventory - AM & PM.

3. Be able to notify the government of acute shortages and redirect product as needed (parameters will be provided)

4. Retail chains receiving product must participate in CDC’s/Healthmap’s MedFinder tool (information for MedFinder and enrollment to be provided)

4.5 Storage and Distribution: The products produced and stored under this contract must be

FDA approved and shall be manufactured in accordance with the conditions approved by the Food and Drug Administration under appropriate patents for the medication. The current Good Manufacturing Practice regulations (cGMP's) as defined by the 21CFR will be the standard to be applied for manufacturing, processing, fill and finish of drugs.

4.6 Returns: The successful offeror must have the ability to accept all returns from pharmacies for 90 days post period of defined emergency response consistent with its normal operating reverse logistics functions.

4.7 Dedicated Resources: Vendor has dedicated point of contact assigned to this effort/contract who has the decision making authority for vendor participation/operations/execution.

C. 5. Liability Protection

All persons and companies that are involved in product distribution and dispensing/administration during an emergency will be protected under the PREP Act and therefore have liability protections in place.

C. 6. Reporting

Unless during an event, reports are due on the fifteenth (15 th) day of each month.

C. 7. Product Quantity Product listed below is in Eaches (Capsules) Product 2019 2020 2021 2022 2023

Oseltamivir

30mg

Capsules

5,874,808 5,874,808 5,874,808 5,874,808 5,874,808

Oseltamivir

75mg

Capsules

50,742,218 50,742,218 50,742,218 50,742,218 50,742,218

Zanamivir

5mg

1,971,923 1,971,923 1,971,923 1,971,923 1,971,923

The stored, VMI, or R-VMI product quantity will be dependent upon vendor capabilities however the Government intends for this quantity to not be lower than the cumulative amount for each item listed above.

C. 8. Product Packaging Tamiflu 30mg Capsules- 10 capsules

Tamiflu 75mg Capsules- 10 capsules

Zanamivir (Relenza) 5mg- 1 capsule

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.

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/ORM HHS/OS/ASPR/ORM

200 C Street, SW 200 C Street, SW Washington, DC 20024 Washington, DC 20024

Deliveries via Courier, e.g., UPS, FedEx

Tasha McMillian, Contracting Officer

ASPR/ORM - (202) 205-1502

Room Number – C1A06 O’Neil House Office Building Washington, D.C. 20515

Electronic Submission

Electronic submissions shall be in Adobe PDF, MS Word, Microsoft Excel, and Microsoft Project (as appropriate) via e-mail to Tasha.McMillian@hhs.gov.

mailto:%20Tasha.McMillian@hhs.gov

SECTION E INSPECTION AND ACCEPTANCE

E.1 INSPECTION AND ACCEPTANCE

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

Upon receipt of Final Report and inspection (physical or representative, i.e., pictures), the COR will review and recommend acceptance or rejection; the CO will correspondingly notify the Contractor of acceptance or rejection. If applicable, a task order for the storage of product shall be issued. Any product produced or stored under this contract shall be subject to inspection by the CO and the COR.

2. Announced or unannounced inspections of stockpile quantities may be made at storage facilities by a duly authorized US Government representative, not to exceed two per year and with reasonable notice (i.e. not less than 24 hours).

HHS reserves the right to conduct an audit, either by HHS and/or HHS designee(s), of the facilities used under this contract and all records related to the manufacture, testing and storage of the product.

CLIN Inspect At Inspect By Accept at Accept by

1001 Destination Government Destination Government 1002 Destination Government Destination Government 1003 Destination Government Destination Government

E.2 FAR 52.252-2 CONTRACT CLAUSES INCORPORATED BY REFERENCE (Feb 1998)

This contract incorporates one or more solicitation clauses by reference, with the same force and effect as if they were given in full text. Upon request, the CO will make their full text available. Also, the full text of a clause may be accessed electronically at https://farsite.hill.af.mil/.

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 https://farsite.hill.af.mil/

SECTION F DELIVERIES OF PERFORMANCE

F.1 Period of Performance

a. The base period of contract performance of this contract is anticipated for five years from the date of award.

F.2 Place and Method of Delivery

a. The delivery of the pharmaceuticals shall be F.O.B. Destination unless a VMI structure is awarded.

b. The place of delivery shall be provided on each T/DOR.

F.3 Reporting Requirements.

a. Vendor shall submit to the Contracting Officer and to the Project Officer quarterly progress reports covering the work accomplished during each reporting period. These reports are subject to the technical inspection and requests for clarification by the Project

Officer. These shall be brief and factual and prepared in accordance with the following format:

(1) Quarterly Progress Reports: On the fifteenth (15th) day of each quarter, Vendor shall submit a quarterly progress report to the Contracting Officer Representative and the

Contracting Officer. Vendor shall submit one copy of the quarterly progress report electronically via e-mail. Any attachments to the e-mail report shall be submitted in

Microsoft Word or WordPerfect 9 or a compatible version. A quarterly report will not be required for the quarter where a final report is due. Such reports shall include the following specific information:

a. The contract number and title, the period of performance being reported, Vendor’s name and address, the author(s), and the date of submission;

c. Section I – An introduction covering the purpose and scope of the contract effort;

d. Section II – The report shall detail, document, and summarize the results of work done in performance of requirements of this contract during the period covered, and include a summary of work planned for the next reporting period. Production capacity assessment problems and recommendations to include:

i. Raw material procurement status;

ii. Inventory report of product manufactured and delivered to the USG under this contract;

iii. Quality control testing and purity;

iv. Quality control potency assessment;

v. Quality manufacturing deviations – summary;

vi. FDA inspections and consultation results or recommendations;

vii. Security assessment, problems and recommendations;

viii. Physical storage monitoring and calibration reports for manufactured products.

ix. Overall project assessment, problems encountered and recommended solutions, etc.

x. Current regulatory status and/or status of progress toward achieving licensure in the United States.

e. Section III – An explanation of any difference between planned progress and actual progress, why the differences have occurred, and, if behind planned progress, what corrective steps are planned. The project plan and delivery schedule will be updated in each Quarterly Report and compared to the baseline plan and delivery schedule.

(2) Risk Mitigation Plan: Vendor shall submit a risk mitigation plan within 90 days after contract award and shall provide an updated plan yearly on the anniversary of the contract award.

(3) Shipping Documentation: Upon delivery of product, provide a PDF copy of the shipping documents to the COR and CO.

(4) Dispensing Report: A daily report is due if this CLIN is exercised. Shall provide product quantities, locations, and number of units dispensed. Report due by 1000 for the day before.

(5) Key Personnel Listing: Vendor shall provide a listing of key personnel. In addition, a list of personnel that may be contacted during day to day operations as well as an emergency (24/7/365).

(6) Final Report: A final report is due 30 days prior to the end of the period of performance of the contract.

ITEM DELIVERABLE QUANTITY DUE DATE

1. Quarterly Report – Excel Spreadsheet/WORD

Original – CO One electronic Copy –

COR

NLT the 15th of the month for the preceding quarter

2. Risk Mitigation Plan -

WORD

Original – CO One electronic Copy –

COR

Daily upon direction of CO until cancelled

3. Shipping Documentation - PDF

Original – CO One electronic copy –

COR

Upon shipment

4. Dispensing Report –

WORD

Original – CO One electronic copy –

COR

Upon Dispensing and CLIN Execution

5. Key Personnel Listing Original – CO One electronic copy –

COR

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

6. 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 product 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 product remaining in storage at the Contractor’s facility

b. The USG may request disposal or alternate delivery of unshipped product stored at the Contractor’s facility.

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

F.7 CLAUSES

FAR 52.252-2 CONTRACT CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more solicitation clauses by reference, with the same force and effect as if they were given in full text. Upon request, the CO will make their full text available. Also, the full text of a clause may be accessed electronically at https://farsite.hill.af.mil/.

CLAUSE TITLE DATE

52.211-

Delivery of Excess Quantities Sept-89

52.242-15 Stop Work Order Aug-89

52.242-17 Government Delay of Work Apr-84

52.247-34 F.O.B. Destination Nov-91 https://farsite.hill.af.mil/

SECTION G CONTRACT ADMINISTRATION DATA

G.1. Contracting Officer (CO)

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. Any other commitment, either explicit or implied, is invalid.

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.

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.

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

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

To be identified at the time of award of contract

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

G.3. HHSAR 352.237-75 KEY PERSONNEL (December 2015)

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract (including, when applicable, Human Subjects Testing requirements). If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty days notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.

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

NAME TITLE

[To Be Specified Prior To Award]

G.4. PAYMENT BY ELECTRONIC FUNDS TRANSFER

The Government shall use electronic funds transfer to the maximum extent possible when making payment under this contract. FAR 52.232-33, Payment by Electronic Funds Transfer – System for Award Management (JUL 2013).

G.5. INVOICE SUBMISSIONS

General: The contractor shall submit claims for reimbursement in the manner and format described herein.

Format: Standard Form 1034, "Public Voucher for Purchases and Services Other Than Personal," and Standard Form 1035, "Public Voucher for Purchases and Services Other Than Personal-- Continuation Sheet," or reproduced copies of such forms marked ORIGINAL should be used to submit claims for reimbursement.

In lieu of SF-1034 and SF-1035, claims may be submitted on the payee's letter-head or self-designed form provided that it contains the information stated below:

(a) Contractor’s name, address, telephone number, point of contact

(b) Government agency name, address, telephone number, point of contact

(c) Invoice Number

(d) Date of Invoice

(e) The contract number and task order number and date of task order.

(f) Requisition number indicated on task order.

(g) Contract/task order line item number, description of goods and/or services, quantity and unit price or cost (as appropriate) and total amount.

(h) Equipment. If there is a contract clause authorizing the purchase of any item of equipment, the final invoice must contain the statement indicating that no item of equipment was purchase or included a completed NIH Form entitled, “Report of Government Owned, Contractor Held Property

Number of Copies: An electronic copy sent to the following:

PSC_Invoices@psc.hhs.gov

Contracting Officer Representative (COR) Contracting Officer/Contract Specialist (CO/CS)

Frequency: Invoices submitted in accordance with the Payment Clause shall be submitted upon delivery of goods or services unless otherwise authorized by the contracting officer.

mailto:PSC_Invoices@psc.hhs.gov

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

Preparation and Itemization of the Invoice: The invoice shall be prepared in ink, typewriter or computer printer. The Contractor shall include the following certification at the bottom of the payment request: “I hereby certify that the salaries billed in this payment request are in compliance with the current HHS Salary Rate Limitation Provisions in Section I of the contract.”

Currency: All HHS contracts will be paid in U.S. currency, as offered prices must be stated in U.S. currency as well.

G.6. PAYMENT CONDITIONS

a. The contractor may not invoice for any CLIN prior to delivery and acceptance of services and/or product.

b. Accepted product which falls into any of the following categories shall be replaced by the contractor at no cost to the USG.

1. If product does not meet any criterion outlined in this contract.

2. If product is deemed to be recalled for any reason, as outlined in the Product Recalls, Including Removal and corrections published by U.S. Department of Health and Human Services, Food and Drug Administration, Office of Regulatory Affairs; or based upon Chapter 7 of the Regulatory Procedures Manual of March 2007.

G.7. GOVERNMENT PROPERTY

If this RFP will result in the acquisition or use of Government Property provided by the contracting agency or if the CO authorizes in the pre-award negotiation process, the acquisition of property (other than real property), this paragraph will include applicable provisions and incorporate the HHS Publication (OS) 686, entitled, Contractor's Guide for Control of Government Property, (1990), available at http://www.knownet.hhs.gov/log/AgencyPolicy/HHSLogPolicy/contractorsguide.htm.

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

“Government property” means all property owned or leased by the Government.

Government property includes both Government-furnished property and contractor-acquired property. Government property includes material, equipment, special tooling, special test equipment, and real property. Government property does not include intellectual property and software.

http://www.knownet.hhs.gov/log/AgencyPolicy/HHSLogPolicy/contractorsguide.htm

G.8. POST AWARD EVALUATION OF PAST PERFORMANCE

Contractor Performance Evaluations Interim and final evaluations of contractor performance shall be conducted on this contract in accordance with FAR 42.15. The final performance evaluation shall be completed at the time of completion of work. Interim and final evaluations will be submitted to the Contractor as soon as practicable. The Contractor will be permitted fourteen (14) 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.

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.

G.9. CONTRACT COMMUNICATIONS/CORRESPONDENCE

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

G.10 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.

(a) 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.11 Evaluation of Contractor Performance (Jan 2000)

(a) Purpose

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.12 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.

G.13 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.

G.14 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.15 Press Releases

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.

Public Law and Section No. Fiscal Year Period Covered

G.16 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,…