RFP 75A50324R00004.pdf

SEE ADDENDUMIS CHECKED

CODE 18a. PAYMENT WILL BE MADE BY

CODE

FACILITYCODE

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

OFFEROR

HHS CODE 16. ADMINISTERED BYCODE

X

X

325412

SIZE STANDARD:

% FOR:SET ASIDE:UNRESTRICTED ORASPR/SNS

REQUEST FOR

PROPOSAL

(RFP)

INVITATION

FOR BID (IFB)

10. THIS ACQUISITION ISCODE

REQUEST FOR

QUOTE (RFQ)

14. METHOD OF SOLICITATION

13b. RATING

NORTH AMERICAN INDUSTRY

CLASSIFICATION STANDARD

(NAICS):

SMALL BUSINESS

09/23/2024 1400 ET

09/13/2024

LAMONICA NORWOOD

(No collect calls)

INFORMATION CALL:

FOR SOLICITATION 8. OFFER DUE DATE/LOCAL TIMEb. TELEPHONE NUMBERa. NAME

4. ORDER NUMBER3. AWARD/ 6. SOLICITATION

75A50324R00004

5. SOLICITATION NUMBER

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS 1. REQUISITION NUMBER PAGE OF

1 63 OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

TELEPHONE NO.

17a. CONTRACTOR/

See Section C

15. DELIVER TO

Atlanta GA 30341 Branch Chief SNS ATLANTA Contracts 2945 Flowers Road

9. ISSUED BY

7.

2. CONTRACT NO.

EFFECTIVE DATE

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW

ISSUE DATE

DELIVERY FOR FREE ON BOARD

(FOB) DESTINATION UNLESS

BLOCK IS MARKED

11.

SEE SCHEDULEX

12. DISCOUNT TERMS THIS CONTRACT IS A RATED

ORDER UNDER THE DEFENSE

PRIORITIES AND ALLOCATIONS

SYSTEM - DPAS (15 CFR 700)

13a.

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

(SDVOSB)

HUBZONE SMALL

BUSINESS

8(A)

ASPR/SNS

WOMEN-OWNED SMALL

BUSINESS (WOSB)

ECONOMICALLY DISADVANTAGED

WOMEN-OWNED SMALL

BUSINESS (EDWOSB)

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

(Use Reverse and/or Attach Additional Sheets as Necessary)

HEREIN, IS ACCEPTED AS TO ITEMS:

DATED

KIMBERLY L. GOLDEN

. YOUR OFFER ON SOLICITATION (BLOCK 5),

INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE SET FORTH

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER

ARE

ARE

31c. DATE SIGNED

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (Type or print)

ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY ADDITIONAL

SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

27a. SOLICITATION INCORPORATES BY REFERENCE (FEDERAL ACQUISITION REGULATION) FAR 52.212-1, 52.212-4. FAR 52.212-3

AND 52.212-5 ARE ATTACHED. ADDENDA

26. TOTAL AWARD AMOUNT (For Government Use Only)

OFFER

STANDARD FORM 1449 (REV. 11/2021)

Prescribed by GSA - FAR (48 CFR) 53.212

ARE NOT ATTACHED.

ARE NOT ATTACHED.

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

30b. NAME AND TITLE OF SIGNER (Type or print)

30a. SIGNATURE OF OFFEROR/CONTRACTOR

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

25. ACCOUNTING AND APPROPRIATION DATA

29. AWARD OF CONTRACT: REFERENCE

See SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS

ASP326936

32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32c. DATE 32b. SIGNATURE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED:

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED INSPECTED

40. PAID BY39. S/R VOUCHER NUMBER38. S/R ACCOUNT NUMBER

37. CHECK NUMBER

FINALPARTIAL

36. PAYMENT

FINALPARTIAL

35. AMOUNT VERIFIED

CORRECT FOR

34. VOUCHER NUMBER33. SHIP NUMBER

COMPLETE

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

42d. TOTAL CONTAINERS42c. DATE REC'D (YY/MM/DD)

42b. RECEIVED AT (Location)

42a. RECEIVED BY (Print)

41c. DATE41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER

41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT

STANDARD FORM 1449 (REV. 11/2021) BACK

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

32f. TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

63 2 of

SECTION A –SOLICITATION DESCRIPTION

(i) This is a combined synopsis/solicitation for commercial products and services prepared in accordance with the format in Subpart 12.6 of the Federal Acquisition Regulation (FAR), as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.

This solicitation will be conducted as a commercial acquisition competed on a full and open basis in accordance with the policies and procedures of Part 12 and Part 15 of the Federal Acquisition Regulation.

(ii) The solicitation number is RFP # 75A50324R00004, which is being issued as a

Request for Proposal (RFP). The Government anticipates the award of a hybrid Firm Fixed Price (FFP)/Time-and-Materials (T&M) type contract as a result of this solicitation.

(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2024-06, effective July 31, 2024. Referenced FAR clauses can be found at www.acquisition.gov.

(iv) This synopsis/solicitation is issued on the basis of full and open competition and is not set aside for small businesses. The NAICS code is 325412 (Pharmaceutical Preparation Manufacturing). The size standard is 1,300 (number of employees).

(v) The Center for the Strategic National Stockpile (SNS), of the U.S. Department of Health and Human Services (HHS), Administration for Strategic Preparedness and Response (ASPR), has a requirement for Pegfilgrastim 6MG/.06ML (INJ, SOLN, SYR, or Autoinjector) and Vendor Managed Inventory (VMI) services. See Section B below for line-item numbers and product, quantities, and units of measure.

(vi) See Section C below for description of requirements.

(vii) The period of performance is anticipated to be a one-year base period and four (4) 12-month optional ordering periods. See below for place(s) of delivery and acceptance and FOB point(s).

(viii) The provision at FAR 52.212-1, Instructions to Offerors-Commercial Products and Commercial Services, applies to this acquisition. The Government intends to award without discussions (although it reserves the right to conduct discussions). Therefore, the submitted proposal should represent the offeror’s best offer.

(ix) The provision 52.212-2, Evaluation-Commercial Products and Commercial Services, applies to this procurement. Addenda to the provision include evaluation factors and evaluation criteria.

(x) The provision FAR 52.212-3, Offeror Representations and Certification—Commercial

Products and Services, applies to this acquisition. Offerors shall include a completed copy of FAR 52.212-3, Offeror Representations and Certifications-Commercial Products and Commercial Services, with its offer. Refer to Attachment 5. (Note, if offerors are http://www.acquisition.gov/ registered within the System for Award Management (SAM) and certs and reps are up to date, make a statement to that affect in accordance with this clause).

(xi) The clause at 52.212-4, Contract Terms and Conditions-Commercial Products and

Commercial Services, applies to this acquisition.

(xii) The clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Products and Commercial Services, applies to this acquisition and applicable FAR clauses include 52.219-9, 52.219-16, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-35, 52.222-36, 52.222-37, 52.222-40, 52.225- 5, 52.225-13, and 52.232-33. Other applicable clauses, including Health & Human Services Acquisition Regulation (HHSAR) clauses, are included below. See Section I below for details.

(xiii) There are no special contract requirements or terms and conditions related to contract financing arrangements.

(xiv) HHS reserves the right to exercise priorities and allocations authority with respect to this contract, to include rating this order in accordance with 45 CFR Part 101, Subpart A—Health Resources Priorities and Allocations System.

(xv) The point of contact for information regarding this combined synopsis/solicitation is:

Contract Specialist:

LaMonica Norwood Division of Operational Contracting (DOC) Office of Head of Contracting Activity (OHCA) Administration for Strategic Preparedness and Response (ASPR) U.S. Department of Health and Human Services (HHS) Email: OSContracting@hhs.gov mailto:lamonica.norwood@hhs.gov

SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS

B.1 Itemized Breakdown of Pharmaceutical Supplies:

Base Year: 30 September 2024 – 29 September 2025

CLIN SUPPLIES/SERVICES QTY/UNIT UNIT

PRICE

EXTENDED

PRICE

0001 Base Quantity

Pegfilgrastim 6MG/.06ML (INJ, SOLN, SYR or autoinjector) in accordance with the SOW herein. This is a Firm Fixed Price Line Item

18,300 EA

0002 VMI Services in accordance with the SOW herein. VMI services for up to 18,300 EA Pegfilgrastim (INJ, SOLN, SYR or autoinjector)

This is a severable service Firm Fixed Price Line Item

QTRLY

0003 Transportation Services in accordance with the SOW herein. Transportation services for up to 18,300 EA Pegfilgrastim (INJ, SOLN, SYR or autoinjector)

This is a severable service Time and Material (T&M) Line Item.

1 LOT NOT TO EXCEED

Total Base Year Price:

Optional Ordering Period 1: 30 September 2025 – 29 September 2026

CLIN SUPPLIES/SERVICES QTY/UNIT UNIT

PRICE

EXTENDED

PRICE

1001 Option for Increased Quantity

Pegfilgrastim 6MG/.06ML (INJ, SOLN, SYR or autoinjector) in accordance with the SOW herein. This is a Firm Fixed Price Line Item

10,500 EA

1002 Option for Services

(VMI Services) in accordance with the SOW herein. VMI services for up to 28,800 EA Pegfilgrastim (INJ, SOLN, SYR or autoinjector)

This is a severable service Firm Fixed Price

1003 Option for Services

Transportation Services in accordance with the SOW herein. Transportation services for up to 28,800 EA Pegfilgrastim (INJ, SOLN, SYR or autoinjector)

This is a severable service Time and

Total Optional Ordering Period 1 Price:

Optional Ordering Period 2: 30 September 2026 – 29 September 2027

PRICE

EXTENDED

PRICE

2001 Option for Increased Quantity

Pegfilgrastim 6MG/.06ML (INJ, SOLN, SYR or autoinjector) in accordance with the SOW

2002 Option for Services

VMI Services in accordance with the SOW herein. VMI services for up to 39,300 EA Pegfilgrastim (INJ, SOLN, SYR or autoinjector)

This is a severable service Firm Fixed Price

2003 Option for Services

Transportation Services in accordance with up to 39,300 EA Pegfilgrastim (INJ, SOLN, SYR or autoinjector)

This is a severable service Time and

Total Optional Ordering Period 2 Price:

Optional Ordering Period 3: 30 September 2027 – 29 September 2028

PRICE

EXTENDED

PRICE

3001 Option for Increased Quantity

Pegfilgrastim 6MG/.06ML (INJ, SOLN, SYR or autoinjector) in accordance with the SOW

3002 Option for Services herein. VMI services for up to 49,800 EA Pegfilgrastim (INJ, SOLN, SYR or autoinjector)

This is a severable service Firm Fixed Price

3003 Option for Services up to 49,800 EA Pegfilgrastim (INJ, SOLN, SYR or autoinjector)

This is a severable service Time and (T&M) Material Line Item.

Total Optional Ordering Period 3 Price:

Optional Ordering Period 4: 30 September 2028 – 29 September 2029

PRICE

EXTENDED

PRICE

4001 Option for Increased Quantity

Pegfilgrastim 6MG/.06ML (INJ, SOLN, SYR or autoinjector) in accordance with the SOW

4002 Option for Services herein. VMI services for up to 60,300 EA Pegfilgrastim (INJ, SOLN, SYR or autoinjector)

This is a severable service Firm Fixed Price

4003 Option for Services up to 60,300 EA Pegfilgrastim (INJ, SOLN, SYR or autoinjector)

This is a severable service Time and

Total Optional Ordering Period 4 Price:

Overall Total Price for all CLINs (Base Year and Optional Ordering Periods):

SECTION C – DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

Statement of Work Pegfilgrastim 6MG/.06ML (INJ, SOLN, SYR, or Autoinjector) and Vendor Managed Inventory (VMI)

C.1 Background:

The Health and Human Services (HHS) Administration for Strategic Preparedness and Response (ASPR) leads the nation’s medical and public health preparedness for, response to, and recovery from disasters and other public health emergencies. ASPR collaborates with hospitals, healthcare coalitions, biotech firms, community members, state, local, tribal, and territorial governments, and other partners across the country to improve readiness and response capabilities.

The Center for the Strategic National Stockpile (SNS) is a national repository and responsible for stockpiling and deploying pharmaceuticals, vaccines, medical supplies, and equipment stored in strategic locations around the nation. These pharmaceuticals and medical supplies are strategically stored in a network of warehouses across the country for rapid deployment to protect the U.S. population against threats, such as anthrax, botulism, smallpox, plague, tularemia, and viral hemorrhagic fevers, as well as emerging infectious diseases, pandemic influenza, natural disasters, and other chemical, biological, radiological, and nuclear incidents.

These assets are designed to supplement state and local public health departments in the event of a large-scale public health emergency that depletes local supplies during an emergency operation.

When state, local, tribal, and territorial public health and medical systems request federal assistance to support their response efforts, the SNS ensures that the right pharmaceuticals, supplies, and equipment get to those who need them most during a public health emergency or pandemic event.

C.2 Purpose/Objectives:

Vendor Managed Inventory (VMI) is a supply chain strategy where the supplier takes responsibility for managing and replenishing inventory levels at the customer's location. This involves continuous monitoring of inventory data provided by the customer, allowing the supplier to determine when and how much inventory to replenish. The goal is to optimize inventory levels, reduce stockouts, and improve overall supply chain efficiency. The goal is to effectively rotate government pharmaceutical products into the commercial market, ensuring optimal inventory utilization and minimizing waste, particularly for items with limited shelf life.

The Strategic National Stockpile’s objective is to procure Food and Drug Administration (FDA) approved units of Pegfilgrastim 6MG/.06ML injection solution in syringe or autoinjector format (INJ, SOLN, SYR, or Autoinjector) with the FDA approved indication for treatment of hematopoietic subsyndrome of acute radiation syndrome, and Vendor Managed Inventory (VMI) services to maintain stockpiling capabilities for responding to public health events throughout the U.S.

Pegfilgrastim is used to treat neutropenia in individuals acutely exposed to myelosuppressive doses of radiation during a mass casualty radiological event. It is utilized to reduce the number of infections, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. It is important for SNS to have a long-acting cytokine option that is dosed only once weekly in order to enhance emergency preparedness during a radiation/nuclear event with multiple/mass casualties.

Pegfilgrastim is a pegylated form of filgrastim, a recombinant human granulocyte colony-stimulating factor (G-CSF) that stimulates the production of white blood cells, specifically neutrophils, in the bone marrow. This medication is primarily used to reduce the risk of infection in patients exposed during an event. Pegfilgrastim is a pegylated form of filgrastim, which means it has a polyethylene glycol (PEG) molecule attached to it. This modification extends the half-life of the drug, allowing for less frequent dosing. Pegfilgrastim is administered as a single injection, usually subcutaneously, and is used to reduce the duration of neutropenia following chemotherapy.

Its prolonged action allows for fewer injections compared to other types of cytokines. The goal is to maintain uninterrupted access to the product(s) in the event of and during public health emergencies.

C.3 Scope of Work:

The government requires up to 60,300 units of pegfilgrastim 6MG/.06ML (INJ, SOLN, SYR, or Autoinjector) that has the FDA approved indication for treatment of hematopoietic subsyndrome of acute radiation syndrome, along with vendor management inventory services for the storage, rotation, inventory management, preparation, transportation and dispersal of the units of stored pegfilgrastim that were procured in accordance with this requirement over a 60-month period (consisting of a one year base period and four (4) 12-month optional ordering periods) should all options be exercised.

C.4 Technical Requirements:

a. The Contractor, as an independent organization and not as an agent of the Government, shall procure and furnish all labor, materials, supplies, facilities, equipment, and transportation necessary to provide the required goods and services.

b. The Contractor is responsible for supplying all necessary relevant permits, support, and infrastructure to supervise the inventory management for up to 60,300 units of Pegfilgrastim 6MG/.06ML (INJ, SOLN, SYR, or Autoinjector) that has the FDA approved indication for treatment of hematopoietic subsyndrome of acute radiation syndrome.

c. The Contractor shall ensure that Pegfilgrastim 6MG/.06ML (INJ SOLN, SYR or Autoinjector) is FDA approved, with the indication for treatment of hematopoietic subsyndrome of acute radiation syndrome.

d. All products must be managed in compliance with applicable regulations administered by the Department of Health and Human Services (HHS), Food and Drug Administration (FDA), Department of Transportation (DOT), Occupational Safety and Health Administration (OSHA), and all relevant Federal, State, and local laws. This includes receiving, storing, packaging, and transporting the products. Additionally, materials management must adhere to the FDA’s current Good Manufacturing Practices (cGMP) as outlined in 21 CFR Part 210 and 21 CFR Part 211.

e. The Contractor shall have the ability to service the continental United States and must possess an inventory system capable of providing up to date information on all Government owned inventory, including quantity and location.

f. The finished drug product delivered under this contract shall be Trade Agreement Act (TAA) compliant.

g. The contractor shall provide a detailed description of the organization’s production capacity, scalability for increased demand, and lead times across all ordering periods. Include production plans, historical performance data, and a strategy for ramping up production when necessary. Identify potential risks to delivery and outline comprehensive risk mitigation strategies, including a thorough risk assessment, mitigation approaches, and contingency plans to ensure a continuous and reliable supply. Describe the approach to inventory management, detailing how sufficient stock levels will be maintained for both regular and emergency demands, including replenishment procedures and the use of backup manufacturing sites. Supporting documentation should include inventory reports, replenishment strategies, and backup plan documentation.

C.5. Task 1: Pegfilgrastim Product Requirements

a. The Contractor shall provide up to 60,300 units of Pegfilgrastim 6MG/.06ML (INJ, SOLN, SYR, or Autoinjector) with the FDA approved indication for treatment of hematopoietic subsyndrome of acute radiation syndrome.

b. The finished drug product shall be delivered directly to the Contractor’s vendor-managed inventory, until such time it is requested by the Government for transfer to Government custody.

c. The finished drug product shall be packaged in single unit dose syringes or autoinjectors, to provide for the most cost-effective product life-cycle value and performance, and to allow for ease of distribution and use during a declared emergency.

Task 2: VMI Requirements:

a. The Contractor shall provide vendor-managed inventory services for up to 60,300 units of pegfilgrastim 6MG/.06ML (INJ, SOLN, SYR, or Autoinjector) with the FDA approved indication for treatment of hematopoietic subsyndrome of acute radiation syndrome.

b. The Contractor shall store, hold, inventory, perform quality control management, replenish, deploy, and rotate, and transport pegfilgrastim 6MG/.06ML (INJ, SOLN, SYR, or Autoinjector) that has the FDA approved indication for treatment of hematopoietic subsyndrome of acute radiation syndrome. The Contractor is responsible for the secure safe keeping of the finished drug product. The Contractor must have the ability to deploy all Government product across the continental United States upon request.

c. The Contractor shall possess and maintain inventory, adhere to shelf-life criteria, and provide quality control of the finished drug product as necessary in accordance with cGMP federal regulations to ensure that the Government is provided 24/7 availability of the product(s).

d. Storage of the product at the Contractor facility(s) shall be in a secured and properly temperature-controlled area (36° F to 46° F or 2° C to 8° C).

e. Any stored finished drug product must maintain minimum shelf-life expectancy as required by this Contract. The Contractor shall rotate the Government’s finished drug product with the Contractor’s commercial stock in order to maintain the minimum shelf-life expectancy required by this Contract.

f. The finished drug product purchased under this contract shall be located at the Contractor’s storage facility. All inventories at those locations will be shipped on a “First In, First Out” basis, ensuring the most recent dating of inventory for VMI target inventory.

g. The Contractor shall submit monthly reports detailing item specifics and quantities per vendor management inventory storage site to the Contracting Officer or Contracting Officer’s Representative. The Contractor shall include information identifying Government products, either physically or electronically, in these monthly inventory reports.

h. The Contractor shall provide an inventory schedule (as part of the inventory report) that meets the requirements of this Contract. The Contractor’s product inventory schedule shall front load the level of product available to the Government. The Contractor shall store product at one (1) Contractor storage facility approved by the Government for conducting the vendor managed inventory services under the Contract.

i. At the discretion of the Government, and independent of quality testing conducted by the Contractor, the Government reserves the right to conduct inspections and collect samples of the finished drug product that is held in vendor managed inventory by the Contractor at the, or under the vendor managed inventory storage facility.

j. All line-item Government owned finished drug product levels shall be maintained at 100% availability of the Government acquisition. In the event of a shortfall below 100%, the Contractor shall notify the Contracting Officer, the Contracting Officer’s Representative and other officials as designated by the Contracting Officer, within two (2) business days and provide a plan that ensures 100% inventory availability level is obtained within five (5) calendar days following the notification. If replenishment will require more time, the Contractor shall notify the Contracting Officer, the Contracting Officer’s Representative, and other officials as designated by the Contracting Officer, of the required time.

k. The Government will conduct an annual 100% physical inventory of all GFP products stored at the Contractor’s vendor managed inventory storage facility purchased under this contract. The Contractor shall support this physical inventory requirement with personnel and equipment. Any inventory finding will be addressed by the Contractor within ten (10) working days of notice of the finding.

l. At its discretion, the Government may pick up and transport finished drug product from the Contractor’s facility within [2 business days] of advance written notification to the Contractor. The Contractor shall provide the Government access to the Contractor’s facility to pick up and transport finished drug product.

m. Upon expiration or termination (including partial termination) of this contract, the Government may effect final distribution of any finished drug product in the Contractor’s vendor managed inventory by any one or combination of the following methods:

i. The Government may direct the Contractor to ship to a consignee(s) designated by the

Government.

ii. The Government may offer the finished drug product to be repurchased by the

Contractor at the contract price. The Contractor is under no obligation to repurchase the finished drug product.

iii. The Government may require disposal of unshipped finished drug product remaining in vendor managed inventory that are stored at the Contractor’s facility.

Task 3: VMI Accessibility:

a. The Government shall have 24/7/365 access to the Contractor’s vendor managed inventory facility.

b. The Contractor shall have 24/7/365 deployment operations and capability.

c. The Contractor shall be able to deliver product to a SNS identified location within the continental United States within twelve (12) hours of notification.

d. The Contractor shall monitor and maintain specified finished drug product levels and product shelf life in accordance with this Statement of Work.

e. The Contractor shall develop a plan to provide the Government with an accurate inventory of the finished drug product as well as the Contractor storage location should the Government have an immediate need for the finished drug product to be released from the Contractor’s vendor managed inventory in an emergency situation.

f. The Contractor shall provide its FDA approved quality control/quality assurance monitoring plan (as part of the Quality Agreement) that shall ensure appropriate storage conditions of the finished drug product while being held for the Government and include the assurance of monitoring in the vendor managed inventory holdings and in accordance with the quality agreement with the Government. In addition, this Quality Agreement shall outline the responsibilities of both the Contractor and the Government (i.e., ASPR/SNS–Quality Control) for event-driven product custody by the Government. These documents shall be executed by all parties involved in the transport and/or custody of the finished drug product under the vendor managed inventory or the Government.

g. The Contractor shall provide access to the finished drug product as required by the Government. The Contractor shall ensure that its labeling, storage, distribution, and transport programs for the finished drug product are secure and controlled and provide evidence regarding the security and control of its programs upon request. The Quality Agreement with the ASPR/SNS shall align with the Government’s specific product use during a mass casualty event.

Task 4 Readiness Requirements:

a. The Contractor shall maintain a 24/7/365 readiness level to receive and respond to an ASPR/SNS notification to distribute the finished drug product.

b. The Contractor shall have an emergency email and phone number established at which the Contractor’s designated contact person(s) who is on call 24/7/365 shall receive notice to distribute the finished drug product as directed by the Government within specified timeframes.

c. The Contractor must store the finished drug product within the continental United States (CONUS) in one location that enable shipping to emergency sites within twelve (12) hours of notification from the Government. The Contractor must coordinate with the receiving location, load, and start transporting the finished drug product to ASPR/SNS designated sites within twelve (12) hours of receiving a distribution directive from ASPR/SNS. The Contractor must identify, pick, package, and process paperwork for the finished drug product identified for distribution.

d. The Contractor shall make final delivery of the finished drug product to the local site(s) within the continental United States (CONUS) within one (1) business day from the date of shipment as directed by the Government.

Task 5: Freight & Transportation Requirements

The Contractor shall, at the direction of ASPR/SNS, distribute finished drug products in accordance with the SOW. All shipments shall be made using traceable means. The Contractor shall provide transportation tracking information from their facility to the point of need when requested by ASPR/SNS.

A. For each shipment, the Contractor shall provide the following information via email to the ASPR Contracting Officer’s Representative and within twenty-four (24) hours after shipment:

1. Delivery/Order Number/Bill of Lading

2. MFR (manufacturer)/Product #

3. Product Name

4. Qty Shipped

5. Number of Containers/Pallets

6. Date Shipped

7. Estimated delivery date/time

8. Carrier Name

9. Tracking Number(s)

10. Proof of Delivery, provided within twenty-four (24) hours after delivery.

11. Packing Slip

B. The Contractor shall include an outside packing label for each shipping container (defined as a pallet or a full manufacturer case) that must contain the following minimum data elements:

1. Shipper’s address

2. Ship to address

3. Any mark for data/wording directed by the ASPR Contracting Officer’s

Representative and Project Manager

4. Delivery/Order Number

5. Number of Boxes/Cases Shipped (e.g., 1 of 4, 2 of 4, 3 of 4, 4 of 4, etc.)

6. Special handling instructions, as applicable

C. The Contractor shall include an inside packing slip containing the following information:

1. Customer name

2. Ship to address

3. MFR (manufacturer) Part Number

4. Product Name

5. Unit of Issue

6. Qty Shipped

7. Delivery/Order number

8. Customer PO number

D. Finished drug products shall be shipped FOB Destination. The address(es) will be provided by the Contracting Officer’s Representative as part of the notification process and will be to a Government designated location within the continental United States.

The Contractor must adhere to cGMP shipping protocols for small, medium, and large shipments and obtain approval from the Government Quality Control Unit. The Contractor is responsible for preparing products for shipment in accordance with these approved protocols.

E. Under FOB Destination procedures, any damages and any loss of finished drug product that occurs prior to delivery to the Government, including while in storage and in-transit to a Government delivery location, is the responsibility of the Contractor. The Contractor shall notify the ASPR Contracting Officer’s Representative and Project Manager within twenty-four (24) hours after loss or damage of finished drug product is known to the Contractor. The Contractor shall initiate action to replace all damaged or missing finished drug product to the Government within forty-eight (48) hours after the lost or damaged finished drug product is identified. If finished drug product is damaged prior to delivery to the Government, Contractor is responsible for all disposal and replacement costs. If finished drug product is damaged upon delivery, the Government may direct a return of the finished drug product or direct the product to be delivered to a designated location at no cost to the Government. The Government’s rights and remedies stated in this paragraph for loss of or damage to finished drug product are in addition to, and are not a limitation upon, any other rights and remedies available under the contract.

F. The Contractor shall notify the ASPR Contracting Officer’s Representative and Project

Manager within a reasonable time of any delays that may impact scheduled delivery times, but no later than twenty-four (24) hours from the time the delay is known.

Task 6 Delivery & Shipping Requirements:

a. Notification to release product(s) under this contract shall be submitted in writing to the Contractor from the Contracting Officer.

b. All shipments shall include packing slips which must list the contract number, product description, NDC or part number, lot numbers, product delivery quantities, and unit of measure (UOM).

c. Storage Requirements for this product shall be on all packing lists.

d. No partial case or packages will be accepted unless approved by SNS in advance.

Final shipment may be less than full quantity.

e. The Contractor shall not mix lot numbers per case or per package. No mixed lot numbers per case or per package will be accepted.

f. The Contractor shall use one lot number per pallet. Only one pallet may contain multiple lot numbers per order.

g. The Contractor shall clearly identify lots with exterior and interior labels.

h. The Contractor shall ensure that duplicate lots have one expiration date (i.e., the same two lot numbers should not have different expiration dates).

i. The Contractor shall ensure the finished drug product delivered to the SNS shall have no more than 50% of shelf-life expended upon delivery.

j. Shelf-life data shall be included on all packing lists, inner packaging, and outer case.

k. The Contractor shall include the product description, National Drug Code (NDC)/Part number, lot numbers, and package quantities on each case, box/inner package/etc., and the packing list. Note: NDCs must use the 5+4+2 standard digit methodology (xxxxx-yyyy-zz). Leading zeros may be utilized on the 5-digit section and/or the 4-digit section and/or the 2-digit section within the NDC methodology. Inner packaging shall also include the following: dosage information, expiration date, storage temperature data, and manufacturer information.

l. The Contractor shall ensure all pallets have the identical TI-HI stack pattern (TI refers to the number of cases making up a tier on a pallet and HI refers to the number of tiers on a pallet) except for the final pallet.

m. The Contractor shall ship cartons in master cartons, which shall be palletized. All finished drug product shall be delivered on standard heat-treated 48” by 40” pallets, not to exceed 60” in height. Pallets must be stretch wrapped and secured to pallet for safe transport.

n. The Contractor shall contact the designated SNS point of contact to schedule delivery appointments no later than forty-eight (48) hours prior to shipping any product but as far in advance as possible (delivery times are Mon – Fri 8:00 AM – 3:00 PM ET).

o. The Contractor must adhere to applicable FDA labeling regulations.

p. No deliveries accepted on weekends without prior approval of the Contracting

Officer’s Representative, Contracting Officer, or other designated authorized individual.

q. The Contractor shall inform all delivery personnel before entry at each SNS location that delivery personnel must submit identification and have vehicle inspected.

r. The Contractor shall ship all finished drug product under appropriate conditions (i.e., temperature, weight limitations, etc.). The Contractor shall provide confirmation of delivery to ASPR/SNS by email within twenty-four (24) hours of delivery in a format specified by the Contracting Officer’s Representative.

s. The Contractor shall adhere to all approved shipping protocols and provide status to the Government as the finished drug product is transported. The Contractor shall maintain accurate records of outbound finished drug product shipments that are auditable and reconcilable by the Contractor and the Government. The Contractor shall maintain an inventory record and location system for the finished drug product throughout the term of the contract, including option years. All documentation related to finished drug product quantities shall be retained by the Contractor and made available to the Government upon request throughout the contract, including option years.

C.6 End-of-Contract Packaging and Marking Requirements:

1. This section only applies if the Government orders product to be released/shipped from the vendor managed inventory facility(s) at the conclusion of the contract (whether in the case of early termination or end of period of performance).

2. All postage and fees related to submission of information, including forms, reports, etc.

to the ASPR/SNS Project Manager or other persons designated to receive the information shall be paid by the Contractor.

3. All product delivered under this contract shall be packaged, marked, and shipped in accordance with Government specifications and FDA regulations. At a minimum, each delivery shall include the following information at time of delivery.

a. Ordering Agency

b. Packing Slip with Tender Number

c. Description of Product

d. Tender Number

e. Contractor Name and Address

f. Storage Requirement shall be on all packing list

g. Lot Numbers

h. Quantity

i. Shelf life or expiration data

j. National Drug Code (NDC) or part number

k. National Stock Number (NSN)

C.7 Returns and Recalls:

1. If the applicable manufacturer of pegfilgrastim conducts a recall or market withdrawal involving the finished drug product distributed by Contractor on behalf of SNS or warehoused by Contractor on behalf of SNS under this Contract, the Contractor must coordinate the recall of any distributed finished drug product per the manufacturer’s direction. The Contractor shall be responsible for any shipment of recalled finished drug product back to the manufacturer or SNS shall be subject to the Freight and Transportation costs.

C.8 Final Distribution to Government:

a. The Government may elect to direct the Contractor to ship all products remaining in the Contractor’s vendor managed inventory facility(s) to a consignee(s), as designated by the Government.

b. The Government may offer the finished drug product to be repurchased by the Contractor at the original purchase price. The Contractor is under no obligation to repurchase the finished drug product.

c. The Government may request disposal of unshipped finished drug product remaining in the Contractor’s vendor managed inventory facility(s).

d. Notification of and Release of Product Procedures:

i. In the event the Government requires deployment of all, or any portion of, the required finished drug product, the Government will provide the Contractor with a Contracting Officer, or Contracting Officer’s designee’s, “Notification of Release of Product” reflecting the quantity and finished drug product required to be released/deployed as well as directions on where the finished drug product needs to be shipped to.

ii. The Contracting Officer or authorized representative designated by the Contracting Officer (i.e., Contracting Officer’s Representative) shall provide the Contractor with an initial list or memo identifying the personnel authorized to issue a “Notification of Release of Product following the Kickoff Meeting and shall provide updates to the list/memo when changes occur.”

iii. No other person shall be entitled to authorize a release/deployment of finished drug product unless the Contractor has been advised in advance, in writing by one of the approved Government representatives as to the addition/change in authorized representatives. All authorizations for release of finished drug product for deployment shall be confirmed by an authorized Government representative.

iv. Within thirty (30) minutes of receiving a release notification, the Contractor shall acknowledge receipt in writing, to the Contracting Officer and the authorized official issuing the notification.

v. The Contractor shall provide a Final Report with a summary of all deliveries under performance of this contract within 5 business days from final delivery or end of contract, whichever comes first.

C.9 Shelf Life

a. The Contractor shall provide finished drug products with the longest shelf life.

b. Initial Shelf Life: Stored finished drug product shall be rotated with the Contractor’s commercial stock to ensure product does not expire and has no less than six (6) months of dating.

c. Product shall have 90% of Shelf-Life remaining at time of delivery (not applicable to VMI deployment).

d. End of Contract Shelf Life: Upon conclusion of the period of performance of the contract and/or if the vendor managed inventory services are no longer necessary, the product delivered to the SNS shall have no more than 50% of shelf-life expended upon delivery.

C.10 Place of Performance:

a. Vendor managed inventory services shall be performed at the contractor facility.

C.11 Period of Performance:

b. The period of performance will be one 12-month base period and four 12-month option years.

C.12. Itemized Breakdown of Pharmaceutical Supplies:

Year Product Quantity Base Year Ordering Period Year 1 Pegfilgrastim 6MG/.06ML (INJ, SOLN, SYR or

Autoinjector) 18,300 units

Optional Ordering Period Year 2 Pegfilgrastim 6MG/.06ML (INJ, SOLN, SYR or Autoinjector)

Up to:10,500 units

Optional Ordering Period Year 3 Pegfilgrastim 6MG/.06ML (INJ, SOLN, SYR or Autoinjector)

Up to:10,500 units

Optional Ordering Period Year 4 Pegfilgrastim 6MG/.06ML (INJ, SOLN, SYR or Autoinjector)

Up to:10,500 units

Optional Ordering Period Year 5 Pegfilgrastim 6MG/.06ML (INJ, SOLN, SYR or Autoinjector)

Up to: 10,500 units

C.12.1 Itemized Breakdown of VMI Services:

Year Services Period

Base Year Ordering Period Year 1 VMI Services QTRLY

Optional Ordering Period Year 2 VMI Services QTRLY

Optional Ordering Period Year 3 VMI Services QTRLY Optional Ordering Period Year 4 VMI Services QTRLY

Optional Ordering Period Year 5 VMI Services QTRLY

C.12.3 Transportation Services

Year Services Base Year Ordering Period Year 1 Transportation Services

Optional Ordering Period Year 2 Transportation Services Optional Ordering Period Year 3 Transportation Services

Optional Ordering Period Year 4 Transportation Services Optional Ordering Period Year 5 Transportation Services

C.13 Quality Assurance:

The Contractor shall adhere to all applicable cGMP requirements and Government quality assurance requirements. The Contractor shall ensure the appropriate operation of its storage facility in accordance with all applicable laws, regulations and the terms and conditions of this contract, including, but not limited to, receiving, preparing, holding, and preparation for shipping finished pharmaceuticals, and other Government assets. The Contractor shall apply knowledge of how a quality assurance program manages the range of complex pharmaceutical product requirements under cGMP to maintain pertinent quality characteristics such as product integrity and reliability. The Contractor shall verify manufacturing, packing, shipping and storage methods, techniques, and special processes to document the interrelationship of product to equipment and environmental conditions. The Contractor shall develop and implement appropriate plans and approaches to ensure effective control of product quality. As appropriate, the Contractor shall incorporate new and innovative conceptual approaches, technologies, and methods for enhancing the assessment of quality performance and identifying areas for improvement.

As evidenced by the COVID-19 response, maintaining a safe and healthy working environment is critical to the United States in providing life-saving medical supplies and equipment. The Contractor shall utilize preventative measurements and standard operating procedures (SOPs) to address essential personnel, personal protective equipment, cleanliness, and restrictive areas prior to such events. During such conditions that represent a public health emergency or other conditions that represent a danger to human life or safety, the Contractor shall work with SNS and limit building access immediately, especially on the warehouse floor, when deemed necessary and appropriate by SNS, during certain human-to-human transmitted diseases or viruses; Chemical, Biological, Radiological attacks; certain States of Emergency; terrorist attacks, or similar events. In addition, at a minimum and as approved by SNS, the Contractor shall follow the requirements from HHS and any other cognizant federal agencies when dealing with the identified environments under the specified conditions. These guidelines will be provided by SNS and, if needed, modified based on risk level by SNS. The Contractor shall maintain comprehensive Quality System programs that comply with all applicable Federal, state, and local regulations and the Government performance requirements cited throughout the contract for the warehousing (i.e., receiving, holding, and shipping preparation) of finished pharmaceuticals, and other Government assets.

The Government will assess the Contractor’s facility and quality systems within sixty (60) calendar days after award, and on an annual basis, and make a determination about the site’s acceptability and compliance to properly and safely store and handle the Government-owned finished drug product. The assessment agenda will include, but not be limited to, a review of the following areas covering the receiving, holding, and shipping preparation of finished drug product:

1. Standard operation procedures (SOPs)

2. Inventory management

3. Software and equipment validations

4. Deviation system

5. Corrective Action and Preventive Action system

6. Quality Assurance

7. Change Control

8. Training management system

9. Facility maintenance

10. Equipment maintenance and calibration

11. Environmental Monitoring

12. Facility Sanitation program

13. Document control system

14. Vendor management program

15. Organization and personnel qualifications and responsibilities

16. Regulatory inspection history (482, 483, warning letter, etc.)

Upon completion of a Government quality assessment site visit, the Contractor shall receive a written formal assessment report. Upon the contractor’s receipt of the Government’s written formal assessment report, the Contractor shall have thirty (30) calendar days to respond in writing to the Government’s required and/or suggested improvement recommendations with proposed corrective actions and target dates for completion. After receiving the Contractor’s written responses, the Government will determine if the Contractor’s completed/proposed corrective actions are sufficient to allow Government-owned product to be stored at the facility.

The Government may conduct “for cause” audits to address product quality or safety concerns within ten business days of notification to the contractor. The Government will schedule quality assessments thirty (30) calendar days in advance, when possible. A quality assessment agenda shall be provided by the Government prior to the assessment date. Additional manufacturer audits may be conducted during each calendar year. The Government will engage the manufacturer to schedule quality assessments thirty (30) calendar days in advance, when possible. A quality assessment agenda shall be provided to the contractor prior to the assessment date.

b. Document Control Program- The Contractor shall maintain a formal document control program to manage the approval, distribution, archival, and change control of all cGMP-relevant documents. This program shall minimally include SOPs, manuals and protocols, software and equipment validation documents, and training records covering the receiving, holding, and shipping preparation of product, and it shall be made available to the Government.

c. Standard Operating Procedures- The Contractor’s performance responsibilities and activities shall be described and controlled in contractor SOPs applicable to receiving, holding, preparing, and shipping preparation of product. All Contractor employees performing under the contract shall be trained on all approved SOPs applicable to assigned tasks prior to performing the tasks in areas that may affect Government-owned finished drug products.

Current, approved, and controlled SOPs shall be readily available to Contractor employees at the facility. At the Government’s request, the Contractor shall make available Contractor SOPs to the Government for review. The Contractor shall update SOPs as necessary to reflect any regulatory changes that may impact operations.

d. Training Program- The Contractor shall implement a training plan that defines the training requirements for all employees performing under the contract including the receiving, holding, and distributing of product. The Contractor-provided training shall be for the particular operations that the contractor performs and based on cGMP practices. All Contractor employees performing under the contract shall be trained on all approved SOPs applicable to assigned tasks prior to performing the tasks in areas that may affect Government-owned finished drug products. Annual cGMP training shall be provided by the Contractor and conducted by qualified individuals to ensure that employees remain familiar with cGMPs.

The Contractor shall ensure all subcontractors used by the Contractor to perform functions that may have an impact on Government-owned finished drug products have the training and skills to perform under any resulting contract. All subcontractors shall be regularly evaluated by the prime contractor to ensure performance and quality compliance. Subcontractor evaluation records identifying acceptable subcontractors, their evaluation, and evaluation criteria used shall be documented and available for review by the Government upon request.

e. Facility Temperature/Humidity Monitoring System- The Contractor shall maintain written procedures describing the equipment installation, operation, performance, maintenance (including scheduled storage temperature alarm testing), and Out-Of-Specification (OOS) reporting (including emergency contact information with back-up personnel) of all temperature-controlled storage areas/units and provide this information in the Temperature Report. The Contractor shall monitor relative humidity in all storage areas (excluding reach-in units) and have a number of probes to accurately record the relative humidity.

1. Each Cold Storage Unit (CSU) temperature monitored area shall have a preapproved number of primary temperature probes and back-up temperature probes positioned in the coldest and hottest spots of the unit based on the latest temperature mapping. Controlled Room Temperature areas shall have primary and back-up temperature probes to accurately record the environmental conditions.

2. Each Reach-in Unit (Cooler/Freezer) temperature monitored area shall have a…