Request for Proposal _75A50122R00021 Thrombocytopenia PBS _ Amendment 1.pdf

NOTE TO OFFERORS

The information in SECTION A - Solicitation/Contract Form, contains important information for any Offeror interested in responding to this solicitation. Any contract resulting from this solicitation will include in its SECTION

A - Solicitation/Contract Form, accounting, appropriation and general information applicable to the contract award.

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 I of this solicitation.

Potential Offerors 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 Offeror's proposal may be included in the resultant contract.

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

The cutoff date for all questions on this Request for Proposal (RFP) is 12 August 2022 at 09:00 AM EST. All questions shall be submitted via e-mail to Jonathan.Gonzalez@hhs.gov and Richard.Hall@hhs.gov.

mailto:Jill.Johnson@hhs.gov mailto:Richard.Hall@hhs.gov

PART I – THE SCHEDULE

SECTION B – SUPPLIES/SERVICES AND PRICE

B.1. BRIEF DESCRIPTION OF SUPPLIES/SERVICES

This acquisition is responsive to the Project BioShield (PBS) Act (2004) and the Pandemic and All-Hazards

Preparedness Act (2006), which charges Biomedical Advanced Research and Development Authority (BARDA) to accelerate the research, development, purchase, and availability of effective medical countermeasures to address radiological and nuclear threats. Radiological and nuclear threats were formally determined by the Department of

Homeland Security (DHS) to present a material threat against the United States population sufficient to affect national security.

Thrombocytopenia, the decrease in platelets, is expected to be a significant health issue following a radiologic event.

It is anticipated that the medical management of thrombocytopenia following a mass casualty event will best be served by employing medical practices already in use for oncological and other medical treatments. BARDA is seeking a medical countermeasure to treat thrombocytopenia arising from the Hematopoietic subsyndrome of Acute

Radiation Syndrome (H-ARS) to augment the United States Government (USG) response capabilities in response to a radiological/nuclear incident.

Project BioShield (PBS) funding for award(s) made under this Request for Proposal (RFP) will support procurement of Final Drug Product (FDP) to be held as Vendor Managed Inventory (VMI) or delivered to the Strategic National

Stockpile (SNS).

The Government has determined a Bona Fide need which will conclude upon the completion of a defined task or defined tasks that provide(s) independent merit and value to the Government. The Contractor's success in completing the required tasks under the work segments must be demonstrated through the Deliverables and

Milestones specified under Article F of this contract. As set forth in the Contract WBS Milestones/Deliverables and

Technical Deliverables chart under Article F of this contract, the agreed to GO/NO GO Contract Milestones and

Decision Gates will constitute the basis for the Government’s decision, at its sole discretion, to exercise any follow-on option period(s).

The periods of performance listed under each of the CLINs under Article B.2. and Article B.3. below are estimated time periods. Those individual time periods may be extended to complete the tasks required under each work segment. It is possible that more than one option period (requirement), may be awarded at one time and that individual CLINs may overlap and/or proceed concurrently.

B.1.1. Definitions

Pharmaceutical Drug Product or Product - means an FDA-approved Medical Countermeasure (MCM) for thrombocytopenia caused by myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation

Syndrome [H-ARS]).

Dose - means an adult or pediatric daily dose of the pharmaceutical product and not a multi-dose vial. The Finished

Drug Product (FDP) shall be packaged in single unit dose syringes or vials or other approved packaging, and potentially as full treatment course packaging, 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.

Unit - means one syringe or one vial, regardless of volume.

Subcontractor - means any supplier, distributor, vendor, or firm that furnishes supplies or services to or for a prime

Contractor or another subcontractor. See, FAR 44.101

Vendor Managed Inventory (“VMI”) - means a product that is the subject of one or more orders and is maintained at inventory levels and the product shelf life pursuant to this contract that is monitored and maintained by the

Contractor in Contractor storage facility(s).

Contractor Storage Facility(s), or other similar phrases (including without limitation Contractor storage facility(s), VMI facility, storage sites, Contractor's facility) indicating the location of VMI of the product that is being managed.

The Contractor Storage Facility(s) shall be approved by the Government for the storage of the Government property.

B.2. PRICES

The final contract(s) will contain the price provisions agreed upon by the US Government (USG) and the

Offeror. Contract(s) awarded under this RFP are anticipated to consist of a base period of up to five years and a series of options that may extend the total period of performance to up to 10-years. CLINs may be broken into sub-

CLINs as required by the government.

CLIN-0001-0003 (Base Period) Pharmaceutical drug procurement to be held as vendor managed inventory (VMI) or delivered to the Strategic National Stockpile (SNS).

CLIN-0004-0006 (Option Period 1) Optional pharmaceutical drug procurement to be held as vendor managed inventory (VMI) or delivered to the Strategic National Stockpile (SNS).

CLIN-0007-0009 (Option Period 2) Optional pharmaceutical drug procurement to be held as vendor managed

CLIN-0010-0012 (Option Period 3) Optional pharmaceutical drug procurement to be held as vendor managed

CLIN-0013-0015 (Option Period 4) Optional pharmaceutical drug procurement to be held as vendor managed

CLIN-0016-0018 (Option Period 5) Optional pharmaceutical drug procurement to be held as vendor managed

All procurement of product (CLIN-0001–CLIN-0018) will be supported under a Firm-Fixed Price (FFP) agreement.

Proposals shall adhere to the CLIN structure summarized in Section B.2.2. The final contract will include a CLIN structure agreed upon by the Government and the Offeror during the pre-award process.

B.2.1. PERIOD OF PERFORMANCE: This requirement has a five-year base period and five 12-month option periods. The total period of performance will not exceed 120-months.

CLIN Period Date

0001-0003 Base 30 September 2022 - 29 September 2027

0004-0006 Option 1 30 September 2027 - 29 September 2028

0007-0009 Option 2 30 September 2028 - 29 September 2029

0010-0012 Option 3 30 September 2029 - 29 September 2030

0013-0015 Option 4 30 September 2030 – 29 September 2031

0016-0018 Option 5 30 September 2031 – 29 September 2032

B.2.1.1. PBS Contract Authority: 42 USC 247d-6b(c) and (g), the Project BioShield Act of 2004.

B.2.1.2. Multi-Year Contract: Multi-year Project BioShield (PBS) contract means a contract for the purchase of supplies or services for more than one, but not more than ten, program years. A multi-year contract may provide that performance under the contract during the option periods and subsequent years of the contract is contingent upon the appropriation of funds, and (if it does so provide) may provide for a cancellation payment to be made to the contractor if appropriations are not made. The key distinguishing difference between multi-year contracts and multiple year contracts is that multi-year contracts, defined in the statutes cited at 17.101, buy more than one year’s requirement (of a product or service) without establishing and having to exercise an option for each program year after the first.

B.2.1.3. Type of Contract:

The Contracting Officer has determined this to be a Firm-Fixed Priced (FFP) Contract for non-commercial supplies and services.

B.2.2. CLIN Structure:

Base Period Firm-Fixed Price CLIN

CLIN Description of Service or Supply Units Unit Price ($) Total ($)

Initial procurement of pharmaceutical drug to be held as vendor managed inventory (VMI) or delivered to the Strategic National

Stockpile (SNS).

Each $ $

Inventory Management as described in Section C.1.4.1. for

Base Period of the Contract Each

Distribution and Shipping Services as described in Section D for Years 1 -5 of the Contract (F.O.B.

Origin, Contractor’s Facility)

Each

Option Period Firm-Fixed Price CLINs

CLIN Description of Service or Supply Units Unit Price ($) Total ($)

Optional period 1 pharmaceutical drug procurement be to be held as vendor managed inventory (VMI) or delivered to the

Strategic National Stockpile (SNS).

Each

Inventory Management as described in Section C.1.4.1. for

Option Period 1 of the Contract Each

Packaging Product for Pickup: Services as described in

SECTION D for Option Period 1 of the Contract (F.O.B.

Origin, Contractor’s Facility)

Each

Optional period 2 pharmaceutical drug procurement be to be held as vendor managed inventory (VMI) or delivered to the

Strategic National Stockpile (SNS).

Each

Inventory Management as described in Section C.1.4.1. for

Option Period 2 of the Contract Each

Packaging Product for Pickup: Services as described in

SECTION D for Option Period 2 of the Contract (F.O.B.

Origin, Contractor’s Facility)

Each

Optional period 3 pharmaceutical drug procurement be to be held as vendor managed inventory (VMI) or delivered to the

Strategic National Stockpile (SNS).

Each

Inventory Management as described in Section C.1.4.1. for

Option Period 3 of the Contract Each

Packaging Product for Pickup: Services as described in

SECTION D for Option Period 3 of the Contract (F.O.B.

Origin, Contractor’s Facility)

Each

Optional period 4 pharmaceutical drug procurement be to be held as vendor managed inventory (VMI) or delivered to the

Strategic National Stockpile (SNS).

Each

Inventory Management as described in Section C.1.4.1. for

Option Period 4 of the Contract Each

Packaging Product for Pickup: Services as described in

SECTION D for Option Period 4 of the Contract (F.O.B.

Origin, Contractor’s Facility)

Each

Optional period 5 pharmaceutical drug procurement be to be held as vendor managed inventory (VMI) or delivered to the

Strategic National Stockpile (SNS).

Each

Inventory Management as described in Section C.1.4.1. for

Option Period 5 of the Contract Each

Packaging Product for Pickup: Services as described in

SECTION D for Option Period 5 of the Contract (F.O.B.

Origin, Contractor’s Facility)

Each

B.3. ADVANCE UNDERSTANDINGS

The final contract may contain advance understandings between the Government and the Offeror. Specific elements of cost, which normally require prior written approval of the Contracting Officer before incurrence of the cost, will be included in this Section if the Contracting Officer (CO) has granted his/her approval prior to contract award.

B.3.1. The USG shall designate in each request for delivery, the specific delivery date for the pharmaceutical drug product or product in the authorized and approved CO written notification.

B.3.2. At least sixty calendar days prior to expiration of this Contract, the Contractor shall notify the USG in writing of the amount and the stock-keeping unit (SKU) type of all remaining products being maintained in VMI by the

Contractor on behalf of the USG.

B.3.3. The Contractor shall negotiate and enter into a Quality Agreement with HHS, Strategic National Stockpile

(SNS), no later than ninety calendar days after Contract award. This Quality Agreement shall outline the responsibilities of both the Contractor and the USG (i.e., SNS–Quality Control and BARDA) for product shipping, receiving, and storage. These documents shall be drafted and signed by all parties prior to the transport and storage of the product.

TRAVEL

No travel is anticipated for this award.

SUBCONTRACTS

Prior written consent from the Contracting Officer in the form of Contracting Officer Authorization (COA) is required for any subcontract that:

• Is of the cost-reimbursement type and exceeds $250,000; or

• Is of the fixed price type and exceeds $250,000 or 5% of the contract, whichever is less.

The Contracting Officer shall request appropriate supporting documentation in order to review and determine authorization, pursuant with FAR Clause 52.244-2, Subcontracts (Jun 2020). After receiving written consent of the subcontract by the Contracting Officer, the Contractor shall provide a copy of the signed, executed subcontract and consulting agreement to the Contracting Officer within ten (10) calendar days.

Note: Consulting services are treated as subcontracts and subject to the ‘consent to subcontract’ provisions set forth in this Section.

RIGHTS IN DATA

No data rights are required or anticipated.

SECTION C – DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities not otherwise provided by the Government as needed to perform the Statement of Work.

C.1.1. Background and Purpose

As outlined in the National Strategy to Combat Weapons of Mass Destruction (WMD) (February 2006), the three pillars of the U.S. strategy are 1) counter-proliferation to combat WMD use, 2) strengthen non-proliferation to combat WMD proliferation, and 3) consequence management to respond to WMD use. The intent of this SOW is to address pillar 3.

The Biomedical Advanced Research and Development Authority (BARDA) plans to acquire a U.S. Food and Drug

Administration (FDA) approved thrombopoietin receptor agonist for use as a medical countermeasure (MCM) that can treat thrombocytopenia arising as a pathology of acute exposure to ionizing radiation that may be a consequence of a radiological/nuclear mass casualty event. Thrombocytopenia (low platelet count) is a blood pathology that can follow acute exposure to certain chemical agents or following a generalized whole-body exposure to high doses of ionizing radiation (IR), likely as a consequence of damage to bone marrow progenitor cells and consumption for vascular injury repair.

Thrombocytopenia is an effect that may arise following exposure to ionizing radiation (i.e., gamma, beta, alpha, or x-rays) or radionuclides with sufficient energy and range of their energy-releasing disintegrations to induce cellular damage, or exposure to and absorption of certain chemicals that can injure the hematopoietic system. While radiation industry accidents have been the prevailing source of human radiation injuries in the last half-century, the intentional use of a chemical weapon or radiological or nuclear device to cause injury has become a possibility. The

Department of Homeland Security (DHS) lists radiological/nuclear threats as risks for hematopoietic, pulmonary, cutaneous or gastrointestinal injury. The radiologic threats include: 1) an attack on nuclear power plants or spent fuel storage facilities; 2) a malevolent act exposing individuals to radiation sources placed in public locations

(radiological exposure device (RED); example: Ir-192 gamma sources for industrial imaging); 3) use of a radiological dispersal device (RDD), such as a “dirty bomb” (isotope dispersal) although other means of dispersion may be encountered; 4) contamination of food or water supplies; or 5) use of an improvised nuclear device (IND) or a military nuclear weapon.

BARDA, working through the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE), has established a drug and biologics development program with a portfolio of products that are under aggressive and rigorous advanced development to meet the requirements established by the Department of Health and Human

Services (HHS) to serve as MCMs for the DHS threat assessments. Upon demonstration of required efficacy and safety, HHS can subsequently procure products for the Strategic National Stockpile (SNS), thereby establishing initial stockpiles of drugs, biologics, medical supplies, etc., needed for federal emergency preparedness, or through vendor-managed inventories (VMI).

C.1.2. Objective

The Objectives of this contract are: 1) to acquire a treatment for use in a mass casualty event where thrombocytopenia or platelet loss is a major concern. The total procurement may be up to 170,000 unit doses. The initial procurement shall be up to 51,000 doses. In each option period additional pharmaceutical doses shall be procured to reach the 170,000 level. The product selected will be procured in stages (i.e., initial purchase of up to

51,000 unit doses, plus up to five additional potential deliveries all over a 10-year period to build towards the requirement need-based quantity); and 2) for the Contractor to provide, as part of the annualized acquisition, a contractor-managed inventory (e.g., VMI) with rotation of stock to control product expiry. The inventory management plan shall also include a plan to provide the SNS with an accurate inventory of product as well as location(s) should the U.S. Government (USG) have an immediate need for product in an emergency situation. The

Contractor's plan to deliver the product as needed by the government, the Quality Agreement with the

Administration for Strategic Preparedness and Response (ASPR), shall be negotiated to align with the USG’s specific product use during a mass casualty event.

In order to meet the above objectives, the Contractor shall have evidence that the labeling, storage, distribution and transport programs are secure and controlled. Below is the estimated pharmaceutical treatment for use in a mass casualty event where thrombocytopenia or platelet loss is a major concern. The contractor shall propose a dosing regimen in a formulation that is suitable for both pediatric and adult populations to meet the procurement objectives for the base and each option period.

Contract

Line-Item

Description

BASE

PERIOD

CLIN 0001-

0003 Initial

Procurement

OPTION

PERIOD 1

CLIN

0004-0006

Additional

Procurement

OPTION

PERIOD 2

CLIN

0007-0009

Additional

Procurement

OPTION

PERIOD 3

CLIN

0010-0012

Additional

Procurement

OPTION

PERIOD 4

CLIN

0013-0015

Additional

Procurement

OPTION

PERIOD 5

CLIN

0016-0018

Additional

Procurement

Estimated

Period of

Performance

30 September

2022 - 29

September 2027

30 September

2027 - 29

September 2028

30 September

2028 - 29

September 2029

30 September

2029 - 29

September 2030

30 September

2030 – 29

September 2031

30 September

2031 – 29

September 2032

Quantity

(doses)

Quantity

(doses)

Quantity

(doses)

Quantity

(doses)

Quantity

(doses)

Quantity

(doses)

Dosing

Regimen

Procurement

51,000 20,000 20,000 20,000 20,000 40,000

Dosing

Regimen VMI 51,000 20,000 20,000 20,000 20,000 40,000

C.1.3. Scope

The USG seeks an FDA-approved MCM for thrombocytopenia caused by myelosuppressive doses of radiation

(Hematopoietic Syndrome of Acute Radiation Syndrome [H-ARS]) by a primary mechanism of action of stimulation of thrombopoiesis (platelet production) or treatment of thrombocytopenia (low platelet count). The finished drug product (FDP) shall be packaged in single unit dose syringes or vials or other approved packaging, and potentially as full treatment course packaging, 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. The packaging shall be the same as a commercial product.

For the Contractor to provide, as part of the Contract, a VMI program for the specified products in which the

Contractor shall monitor and maintain required inventory levels and product shelf life. Provide availability of shipments 24-hours a day, 7-days a week, 365-days a year and shall be able to deploy as requested pursuant to this

Contract. The VMI provided by the Contractor shall include a plan to provide the USG with an accurate inventory of the product as well as Contractor storage location(s) should the USG have an immediate need for the product to be released from VMI in an emergency situation. The Contractor shall participate in simulated deployment exercises.

The Contractor’s plan to provide access to the product as needed by the USG and the Quality Agreement with the

SNS shall align with the USG’s specific product use during a mass casualty event. In order to meet the above objectives, the Contractor shall have evidence that the labeling, storage, distribution and transport programs are secure and controlled.

C.1.4. Product Requirements

This product shall be held in VMI or other managed inventory systems, until such time it is requested by the USG for emergency use and transferred to USG custody. All line-item inventory levels shall be maintained at 100% availability of the USG acquisition. In the event of a shortfall below 100%, the

Contractor shall notify the CO, Contracting Officer’s Representative (“COR”) and/or other officials as designated by the CO, within 2 business days and provide a plan that ensures 100% inventory availability level within 5 calendar days. If replenishment will require more time, the Contractor shall notify the CO, COR, or other officials as designated by the CO, of required time.

If the need for product release/deployment arises, the authorization procedures in Notification of

Release of Product shall be followed.

In the event the USG requires deployment of all or any portion of the required inventory level, the

USG shall then provide the Contractor with a CO or designee’s Notification of Release of Product reflecting the quantity and product(s) released/deployed.

A minimum of 6-months remaining on product shelf life at the time of product release/deployment from VMI is required.

Descriptions of material transfer will be specified in a Quality Agreement between HHS [Strategic National

Stockpile (SNS)] and the Contractor.

The finished drug Product (FDP) shall be packaged in a single unit dose syringes or vials or other approved packaging, and potentially as full treatment course packaging, 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.

Option periods will be exercised in order IAW the period of performance. The Government may choose too or to not exercise an option beyond the initial procurement period. The Contractor shall be notified IAW FAR 52.217-9, if the

Government intends to exercise an option. Likewise, the Government shall notify the Contractor within 60-days of exercising the option, if the next option period will not be exercised. Once the initial procurement or option period end date is reached, without the exercising of the next period of performance, the contract is considered dead The

Government and the Contractor shall negotiate the disposition of the product including the buyback of the product.

The Government shall have the final approval of the disposition of the product.

C.1.4.1. VMI REQUIREMENTS

C.1.4.1.1. Within 15-days of the signing of this Contract, the Contractor shall provide a listing of the names, titles and telephone numbers (non-emergency and emergency) of its key personnel who should be contacted for USG visits, inventory status, and access to and/or deployment of product, and a simulated deployment of the product(s), during normal and after business hours. The Contractor shall notify by telephone and provide the CO and COR in writing any future updates or changes to the listing within 24 hours of making the update or change.

C.1.4.1.2. Within 30-days of the signing of this Contract, the CO will identify to the Contractor those representatives authorized by the USG as requiring access to the Contractor VMI facility(s) for inspection of VMI product availability. The CO shall then notify the Contractor via telephone and in writing of any updates or changes to that list within 24-hours of any such updates/changes.

C.1.4.1.3. The Contractor shall allow announced and unannounced visits to its VMI facility(s) by HHS personnel for the purpose of inspection and review of the required product inventory levels. Quality assessments of

Contractor’s facility and quality systems shall undergo an initial qualification audit. The CO will provide the

Contractor with a minimum of a 48-hour advance notice of any announced visits. A Quality Assessment agenda shall be provided prior to the assessment date. Upon completion of the assessment, HHS shall provide to the

Contractor a written Quality Assessment Report summarizing all findings and recommendations. The Contractor shall provide a written response addressing each finding/recommendation within 30 calendar days from the date report is received by the Contractor. The Contractor shall provide additional information and/or clarification regarding the assessment findings as requested by HHS. HHS will limit visits to no more than 2 per year, per facility, provided that each visit is uneventful, and the Contractor’s performance has been satisfactory. All visits, announced and unannounced, will be limited to normal weekday business hours and non-federal holidays.

C.1.4.1.4. The Contractor shall be responsible to notify the CO and COR within twenty-four hours after any notice of inspection and unscheduled inspections or actions by regulatory agencies, other enforcement agencies (e.g., FDA, DEA, OSHA), and third-party contractors that may involve and/or impact USG purchased Products in VMI. The

USG shall be permitted to delegate at least two persons to observe the inspection. The notifications should be sent electronically to the CO, COR or other officials as designated by the CO.

C.1.4.1.5. The Contractor shall provide the USG with a plan of proposed corrective actions no later than fifteen business days from the USG’s identification of problems regarding storage, inventory management, or other discrepancies identified through scheduled or non-scheduled storage sites visits. Contractor shall make all mutually agreed upon changes pursuant to such agreements as soon as possible.

C.1.4.1.6. Should the USG’s pharmaceutical drug products require an increase in the amount produced or stored in

VMI based on real world events, the USG will contact the Contractor to adjust the amounts of product being procured and/or held in VMI. To achieve the revised requirement level the Contracting Officer shall issue a bilateral modification.

C.1.4.1.7. Should the USG’s requirement for certain National Drug Codes (NDC) change, the USG reserves the right to submit a request, in writing to add or delete NDCs. All changes of this nature shall be mutually agreed upon via a written modification of this Contract. Subject to availability of raw materials, capacity and other operational factors, Contractor shall provide the USG no later than sixty-days following Contract modification with a plan outlining the implementation of product additions to achieve full required inventory availability level.

C.1.4.1.8. If a product covered under this Contract is discontinued or the regulatory status of a product changes

(e.g. from “prescription” to “over-the counter” or other change in approval status), or if Contractor no longer markets, co-markets or sells a product, the Contractor must notify the CO, COR and/or other officials as designated by the CO in writing, and request that the product be deleted from this Contract at minimum of six months prior to the discontinuation of the pharmaceutical drug.

C.1.4.1.9. Contractor shall be a participant in simulated exercises with the USG. The USG anticipates not more than one such exercise during a 12-month period which would involve the Contractor to participate in a teleconference and provide information pertaining to the product stored in the VMI and its deployment during an emergency.

C.1.4.1.10. In the event of a drug recall on any product(s) under this Contract and to the extent it may affect the safety, efficacy or continued supply of the Product(s) covered under this Contract, the recall of product(s) other than those that are covered under this Contract that are manufactured by or at the facilities of the manufacturer of the product(s) covered under this Contract, Contractor shall notify the CO, COR and/or other officials as designated by the CO, in writing within 24-hours of the recall notification.

C.1.4.1.11. Reserved

C.1.4.2. Additional VMI Services

The VMI program shall include storage, holding, inventory management, quality control, stock rotation, secure safe keeping and possible deployment of the product(s).

C.1.4.2.1. The Contractor shall establish and maintain inventory, maintain shelf-life criteria, and provide quality control of product as necessary in accordance with Current Good Manufacturing Practice (cGMP) federal regulations to ensure that the USG is provided 24/7 availability of the product(s) as necessary to support emergency situations. Storage of the product at the Contractor facility(s) shall be in a secured and properly temperature-controlled area. Any stored product must maintain minimum shelf-life expectancy as agreed upon and described within this Contract. It is expected that any stored product shall be rotated with the Contractor commercial/non-commercial stock in order to maintain the minimum shelf-life expectancy agreed upon in this contract.

Inventory shall be located at 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.

C.1.4.2.2. The Product must be FDA approved for a Hematopoietic Syndrome of Acute Radiation Syndrome (H-

ARS) indication, and a plan and operational consideration shall be in place that ensure the product will be stored and shipped in compliance with cGMP.

C.1.4.2.3. The Contractor shall provide their FDA approved quality control/quality assurance monitoring plan that shall ensure appropriate storage conditions of the product while being held for the USG and this shall include the assurance of monitoring in the VMI holdings and in accordance with the Quality Agreement with the USG. In addition, this Quality Agreement shall outline the responsibilities of both the Contractor and the USG (i.e., SNS–

Quality Control and ASPR) for event-driven product custody by the USG. These documents shall be executed by all parties prior to transport and custody of the product under the VMI or the USG.

C.1.4.2.4. The Contractor shall develop an inventory plan that meets the objectives of this Contract. The

Contractor’s product inventory schedule shall front load the level of product available to the USG. The Contractor may propose an alternate schedule. The Contractor shall store Product at a Contractor storage facility approved by the USG for conducting the VMI services under this Contract.

C.1.4.2.5. At the discretion of the USG and independent of quality testing conducted by the Contractor, the USG reserves the right to conduct inspections and collect samples of product that is intended to be held in VMI by the

Contractor at the manufacturing facility(s), satellite sites, or under the VMI.

C.1.4.2.6. A specific place of performance is not necessary for the accomplishment of this Contract, other than that the site(s) must be within the United States or its territories. It will be necessary for the Contractor to store the product in one or more locations that allow it to be shipped to the site(s) of an emergency within hours.

C.1.4.2.7. Upon expiration or termination (including partial termination) of this Contract, the USG may effect final distribution of any product in VMI by any one or combination of the following methods:

a. The USG may elect to direct the Contractor to ship to a consignee(s) designated by the USG, all products remaining in VMI at the Contractor’s facility.

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

c. The USG may request disposal of unshipped products remaining in VMI that are stored at the Contractor’s facility.

C.1.4.3. Notification of Release of Product

Notification to release product(s) under this Contract shall be submitted in writing to the Contractor by the

Contracting Officer or by an authorized representative designated by the CO.

C.1.4.3.1. The USG will provide the Contractor with a current list or memorandum identifying the personnel authorized to release the product.

C.1.4.3.2. The USG representative(s) named in the list are authorized to request a release/deployment of product(s).

No other person shall be entitled to authorize a release/deployment of product(s) unless the Contractor has been advised in advance, in writing by one of the approved USG representatives as to the addition/change in authorized representatives. All authorizations for release of product for deployment will be confirmed by an authorized USG representative. In addition to the issuance and the standard requirements of the USG’s requisition form, a valid request for the release of the product shall be established after the Contract is awarded.

C.1.4.3.3. The Contractor shall acknowledge the USG’s request for deployment within 30-minutes of notification by the CO, or CO authorized USG personnel who have contacted the Contractor in writing. No verbal authorizations shall be approved for the deployment of any VMI, unless there is a validation, that there are no electronic means of distributing a written authorization.

C.1.4.3.4. The Contractor shall be responsible for the packing, palletizing and preparation of the product for shipping and deployment including any necessary shrink wrapping and loading of the product into the transportation vehicles. The required doses shall be available for shipment within 24-hours of the notification

C.1.4.3.5. The Contractor shall provide, at USG request, sufficient climate controlled and non-climate control trucking for the movement of the required product, 24-hours per day, 365-days per year, throughout the United

States and its territories.

C.1.4.3.6. The Contractor shall provide the USG transportation reports (such as order confirmation, pick-up notification, proof of delivery) and monthly completion reports (showing all data such as run number, pick up-date and time, and final costs) to the CO and COR via email.

C.1.4.4. Place of Performance

The Contractor shall provide a secure Government approved storage facility(s) for the VMI pharmaceutical products for the SNS. The Contractor shall maintain pharmaceutical products and rotate stock under an approved managed inventory plan in cooperation with ASPR personnel. The Contractor’s secure Government approved storage facility(s) shall allow deliver of the VMI product in a declared emergency or upon request within the continental US.

ARTICLE C.2. SPECIFIC REQUIREMENTS/TASKS

C.2.1. FDA Licensure

a. The approved label indication shall be to increase survival in adults and in pediatric patients (including term neonates) acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation

Syndrome [H-ARS]); and

b. The approved label shall state the drug’s mechanism of action is through stimulation of thrombopoiesis and/or treatment of thrombocytopenia resulting in a statistically significant increase in platelet counts; and

c. The MCM is effective when administered at 24-hours or more post-radiation exposure

C.2.2. Quality Agreement

The Contractor shall provide their FDA approved quality control/quality assurance monitoring plan that shall ensure appropriate storage conditions of the product while being held for the USG and this shall include the assurance of monitoring in the VMI holdings and in accordance with the Quality Agreement with ASPR. In addition, this

Quality Agreement shall outline the responsibilities of both the Contractor and ASPR for event-driven product custody by the SNS. These documents shall be drafted and signed by all parties prior to the transport and custody of the product under the VMI or the SNS.

C.2.3. Inventory Plan

The Contractor shall develop an inventory plan that meets the objectives of this contract noted above. The

Contractor shall propose a product inventory schedule that front loads the level of product available to the USG.

The Contractor shall store FDP at an appropriate current Good Manufacturing Practice (cGMP) compliant facility.

C.2.4. Program Management

2.4.1. The Offeror shall provide a Program Management and Risk Mitigation Plan that allows timely completion of all Deliverables listed in Section F.

2.4.2. The Offeror shall provide a list of individuals to serve as primary and secondary points of contact who will be notified in case of a public health emergency.

2.4.3. The Offeror shall provide a Security Plan which is associated with all aspects of manufacture of product, process, storage and inventory. The Security Plan shall include all sites within the supply chain, including proposed shipping carriers. For those sites/carriers that are not defined at the time of award or are added during the period of performance, individualized Security Plans shall be provided to the USG prior to inclusion of sites/carriers into the supply chain. BARDA’s Program Protection Office will be authorized to review and approve Security Plans and will conduct annual audits / site visits to ensure a reliable product is delivered to the USG. For additional information on

BARDA security requirements for procurement contracts, see Section J, Attachments 8 and 9.

2.4.4. The Contractor shall establish and maintain an active, enterprise-wide risk management system as well as a specific risk management plan that includes the standard operating procedures (SOPs) governing risk management, a description of the risk management activities required to oversee the project across its range of scope, and the processes for reviewing completed risk mitigations.

ARTICLE C.3. REPORTING REQUIREMENTS

Refer to ARTICLE F.2. for specific instructions regarding Reporting Requirements.

ARTICLE C.4. MEETINGS

C.4.1. KICKOFF MEETING

The Contractor shall complete a virtual kickoff meeting within 30-days after contract award. The Contractor shall provide an itinerary/agenda to the Contracting Officer (CO)/Contract Specialist (CS) and Contracting Officer

Representative (COR) no later than five business days before meeting. Minutes from the kickoff meeting must be provided within 10 business days of the event to the CO/CS and COR.

C.4.2. AD-HOC MEETINGS

At the discretion of the CO, the Contractor shall participate in Project Meetings to coordinate the performance of the contract, as requested by the Contracting Officer’s Representative. These meetings may include teleconferences or face-to-face meetings with the CO, COR, and Subject Matter Experts in Washington, D.C. or at work sites of the

Contractor and its subcontractors. Such meetings may include, but are not limited to, meetings of the Contractor

(and subcontractors invited by the Contractor) to discuss study designs, site visits to the Contractor’s and subcontractor’s facilities, and meetings with the Contractor and HHS officials to discuss the technical, regulatory, and ethical aspects of the program. The Contractor must provide data, reports, and presentations to groups of outside experts (subject to appropriate protections for Contractor’s confidential or proprietary data) and Government personnel as required by the COR, giving reasonable prior notice of such requirement to Contractor, in order to facilitate review of contract activities. Contractor shall provide itinerary/agenda at least five business days in advance of face-to-face meeting.

C.4.3. TABLETOP EXERCISES

If required, a tabletop exercise is intended to bring together the stakeholders to work through a scripted disaster scenario, while focusing on the potential research needs, and more specifically on the various study instruments (e.g., surveys, tools, consent forms); processes and logistics, integration into emergency response operations, safety training); and relationships

(e.g., state and local health officials, emergency managers, area academicians, industry, organizations representing potentially impacted communities and workers) necessary to initiate and sustain needed research investigations. Tabletop exercises also provide an opportunity for ASPR to gauge stakeholder distribution process in the case of an actual national emergency.

SECTION D – PACKAGING, MARKING AND SHIPPING

D.1. PACKAGING OF PRODUCT

Packaging shall be consistent with the FDA-approved labeling and packaging for this product at the time of manufacture.

D.2. MARKING

Marking of product and shipping packages shall be in accordance with FDA-approved labeling direction to be provided at the time of manufacture.

D.3. DISTRIBUTION AND SHIPPING SERVICES

Shipping shall be in accordance with written authorization by the CO for each shipment. The USG may request a number of doses to be delivered to the location of the emergency as requested by the CO in the Notification of

Release of Product for each shipment.

All Products shall be labeled and packaged in accordance with GCP (Good Clinical Practices) and/or cGMP

(Current Good Manufacturing Practices) as appropriate. Products shall be packed to ensure compliance with known product stability requirements that maintain satisfactory product temperatures during transit and arrival at destination. Products shall be packed to ensure maintenance of FDA recommended temperature during transit and safe arrival at destination. Freeze Watch Indicators (FWI) or equivalent temperature indicating devices shall be packed in each container containing the product. The Contractor is required to maintain records that document the date of delivery receipt, and that the product was properly maintained within the recommended cold chain temperatures during Contractor’s transit of Product until receipt of Product by the USG or its designee.

Concurrence on planned shipment protocols shall be obtained from HHS prior to transport.

D.3.1. SPECIFIC SHIPPING SERVICES

The USG may issue a Notification of Release of Product for shipment for a requested number of doses to be delivered to a location as requested by the Contracting Officer or by an authorized representative designated by the

CO.

The Contractor shall perform the following activities for distribution. Following the completion of packaging the product into cartons and master cartons, the master cartons shall be palletized in a pattern suitable for storage and eventual shipment. The pallet pattern shall be standardized for each product type such that the quantity shall be uniform across all full pallets in a lot. The master cartons on the full pallets and partial pallets, if one exists, shall be securely stretch wrapped to the pallet itself in order to prevent damage in transit.

If required, at the time of shipping, a temperature recorder (preferably a TempTale or a functionally equivalent product) shall be placed on each pallet. The temperature recorder shall have alarm limits set based on the established temperature parameters, and they shall be activated when the pallets are placed on the trucks that have been pre-cooled to their target temperature prior to loading. After loading, numbered seals shall be affixed to the cargo doors and the numbers entered on the bill of lading.

The Contractor shall be responsible for delivering USG-owned product in a condition fit for its intended use to shorten the recovery time.

D.3.2. PACKAGE PRODUCT FOR PICKUP BY THE USG

The CO may request the Contractor to transfer product to the USG for pick up at the Contractor’s VMI facility(s).

The Contractor shall perform the following activities to prepare the product for pickup by the USG. Following the completion of packaging the product into cartons and master cartons, the master cartons shall be palletized in a pattern suitable for storage and eventual shipment. The pallet pattern shall be standardized for each product type such that the quantity shall be uniform across all full pallets in a lot. The master cartons on the full pallets and partial pallets, if one exists, shall be securely stretch wrapped to the pallet itself in order to prevent damage in transit.

If required, a temperature recorder (preferably a TempTale or a functionally equivalent product) shall be placed on each pallet. The temperature recorder shall have alarm limits set based on the established temperature parameters, and they shall be activated when the pallets are placed on the trucks that have been pre-cooled to their target temperature prior to loading.

The product shall be inspected and accepted by the USG at the VMI facility(s) prior to being transferred to the USG.

USG will formally transfer possession, title, and custody transfer of the product at the Contractor VMI facility; the

USG will be responsible for all shipping costs and handling all shipping/logistics.

SECTION E – INSPECTION AND ACCEPTANCE

E.1. INSPECTION AND ACCEPTANCE

Inspection and acceptance of the product, services, and documentation called for herein shall be accomplished by the Contracting Officer or designated COR. Technical inspection and acceptance will take place at the Contractors facility or designated location by the COR.

Acceptance may be presumed unless otherwise indicated in writing by the Contracting Officer or the designated

COR within 30-days of receipt.

E.2. FEDERAL ACQUISITION REGULATION CLAUSES INCORPORATED BY REFERENCE

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

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

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

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

E.3. INSPECTION, ACCEPTANCE AND CONTRACT MONITORING

Inspection and acceptance of the product, services, and documentation called for herein shall be accomplished by the Contracting Officer or designated COR. Delivery, technical inspection and acceptance will take place at a location designated by the Contracting Officer or designated Contracting Officer Representative.

At the discretion of the Government and independent of activities conducted by the Contractor, with 48- hours’ notice to the Contractor, the Government reserves the right to conduct site visits and inspections related to this Contract on an as needed basis during normal business hours, including collection of product samples and intermediates held at the location of the Contractor, or its subcontractor. All costs reasonably incurred by the Contractor and subcontractor for such visit and/or inspection shall be allowable costs subject to the Allowable cost requirements in FAR Subpart 31.2.

The Contractor shall coordinate these visits and shall have the opportunity to accompany the Government on any such visits. Under time-sensitive or critical situations, the Government reserves the right to suspend the 48-hour notice to the Contractor. The areas included under the site visit could include, but are not limited to: security, regulatory and quality systems, manufacturing processes and cGMP/GLP/GCP compliance related to activities funded under this Contract.

If the Government, Contractor, or other party identifies any issues during an audit, the Contractor shall capture the issues, identify potential solutions, and provide a report to the Government for review and acceptance:

• If issues are identified during the audit, the Contractor shall submit a report to the CO and COR within five business days detailing the finding and corrective action(s) of the audit.

• COR and CO will review the report and provide a response to the Contractor within ten business days.

• Once corrective action is completed, the Contractor will provide a final report to the CO and COR.

SECTION F – DELIVERIES OR PERFORMANCE

F.1. PERIOD OF PERFORMANCE

The period of performance has a base period of five-years and five 12-month option periods. The total period of performance will not exceed 120-months, as set forth in SECTION B.

F.2. DELIVERIES

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

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

Contracting Officer or designated COR.

F.2.1. Place and method of delivery for Product purchased will be determined at the time of award of each Order by the inclusion of VMI or shipping in that Order. Refer to SECTIONS F.2.2, F.2.3, and F.2.4. for place and method of delivery requirements for those Items.

F.2.2. When Product is purchased, delivery of Product means introduction into VMI.

F.2.3. When distribution and shipping of product is ordered, delivery of drug Product and other deliverables shall be in accordance with FAR 52.247-34 entitled F.O.B. DESTINATION.

F.2.4. When product preparation for pick-up by the USG is ordered, delivery of drug product and other deliverables shall be in accordance with FAR 52.247-30 entitled F.O.B. ORIGIN, CONTRACTOR’s FACILITY.

F.2.5. Place of Delivery: The Product shall be delivered as requested by the CO or authorized representative prior to time of delivery.

F.2.6. A method (e.g., TempTales) for…