75A50123R00003.pdf

75A50123R00003

SOLICITATION, OFFER AND AWARD

4. TYPE OF SOLICITATION2. CONTRACT NUMBER 3. SOLICITATION NUMBER

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

ORDER UNDER DPAS (15 CFR 700)

6. REQUISITION/PURCHASE NUMBER

NOTE: In sealed bid solicitations "offer" and "offeror" mean "bid" and "bidder".

NEGOTIATED (RFP)

SEALED BID (IFB)

5. DATE ISSUED

1. THIS CONTRACT IS A RATED RATING PAGE OF PAGES

1 118

C. E-MAIL ADDRESS

EXT.NUMBERAREA CODE

B. TELEPHONE (NO COLLECT CALLS)A. NAME

10. FOR

INFORMATION

CALL:

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

(Date)(Hour) local timeuntildepository located in copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if hand carried, in the

SOLICITATION

9. Sealed offers in original and

PART IV - REPRESENTATIONS AND INSTRUCTIONS

OTHER STATEMENTS OF OFFERORS

EVALUATION FACTORS FOR AWARD

INSTRS., CONDS., AND NOTICES TO OFFERORS

REPRESENTATIONS, CERTIFICATIONS AND

LIST OF ATTACHMENTS

CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

I

J

K

L

M SPECIAL CONTRACT REQUIREMENTS

CONTRACT ADMINISTRATION DATA

DELIVERIES OR PERFORMANCE

INSPECTION AND ACCEPTANCE

PACKAGING AND MARKING

DESCRIPTION/SPECS./WORK STATEMENT

SUPPLIES OR SERVICES AND PRICES/COSTS

SOLICITATION/CONTRACT FORM

PART II - CONTRACT CLAUSESPART I - THE SCHEDULE

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G

F

E

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B

A

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

11. TABLE OF CONTENTS

18. OFFER DATE17. SIGNATURE

SUCH ADDRESS IN SCHEDULE.

IS DIFFERENT FROM ABOVE - ENTER

15C. CHECK IF REMITTANCE ADDRESS

EXT.NUMBERAREA CODE

15B. TELEPHONE NUMBER

(Type or print)AND

ADDRESS

OF

OFFEROR

CODE FACILITY

16. NAME AND TITLE OF PERSON AUTHORIZED TO SIGN OFFER15A. NAME

DATEAMENDMENT NO.DATEAMENDMENT NO.

and related documents numbered and dated):

amendments to the SOLICITATION for offerors

(The offeror acknowledges receipt of

14. ACKNOWLEDGEMENT OF AMENDMENTS

CALENDAR DAYS (%)30 CALENDAR DAYS (%)20 CALENDAR DAYS (%)10 CALENDAR DAYS (%)

(See Section I, Clause No. 52.232.8)

13. DISCOUNT FOR PROMPT PAYMENT

designated point(s), within the time specified in the schedule.

by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the

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

OFFER (Must be fully completed by offeror)

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

28. AWARD DATE

(Signature of Contracting Officer)

27. UNITED STATES OF AMERICA

25. PAYMENT WILL BE MADE BY

26. NAME OF CONTRACTING OFFICER (Type or print)

CODE 24. ADMINISTERED BY (If other than Item 7)

ITEM

(4 copies unless otherwise specified)

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

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

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

21. ACCOUNTING AND APPROPRIATION20. AMOUNT19. ACCEPTED AS TO ITEMS NUMBERED

AWARD (To be completed by government)

CODE

08/01/2023 X

ASPR-BARDA

ASPR-BARDA

200 Independence Ave., S.W.

Room 640-G Washington DC 20201

1400 ET 09/15/2023

YIFAN ( YANG

Yifan.Yang@hhs.gov

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PAGE(S)

JONATHAN F. GONZALEZ

AUTHORIZED FOR LOCAL REPRODUCTION

Previous edition is unusable

STANDARD FORM 33 (Rev. 9-97)

Prescribed by GSA - FAR (48 CFR) 53.214(c)

12. In compliance with the above, the undersigned agrees, if this offer is accepted within _____60_________ calendar days (60 calendar days unless a different period is inserted

ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

NAME OF OFFEROR OR CONTRACTOR

2 118

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

75A50123R00003

(A) (B) (C) (D) (E) (F)

Period of Performance: 09/29/2023 to 09/28/2033

OPTIONAL FORM 336 (4-86)

Sponsored by GSA

FAR (48 CFR) 53.110

NSN 7540-01-152-8067

RFP 75A50123R00003

Contents

SECTION B – SUPPLIES OR SERVICE AND PRICE / COST

SECTION C – DESCRIPTION/SPECIFICATIONS

SECTION D – PACKAGING, MARKING AND SHIPPING

SECTION E – INSPECTION AND ACCEPTANCE

SECTION F – DELIVERIES OR PERFORMANCE

SECTION G – CONTRACT ADMINISTRATION

SECTION H – SPECIAL CONTRACT REQUIREMENTS

SECTION I – CONTRACT CLAUSES

SECTION J – LIST OF ATTACHMENTS

SECTION K – REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS

SECTION L – INSTRUCTIONS, CONDITIONS AND NOTICES TO OFFERORS

Section M – EVALUATION FACTORS FOR AWARD

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 RFP is Aug 15, 2023 at 12PM ET. All questions shall be submitted via e‐mail to Yifan.Yang@hhs.gov. The due date for all proposal submissions is Sep 15, 2023 at 2PM ET. All proposals must be submitted via email to Jonathan.Gonzalez@hhs.gov and Yifan.Yang@hhs.gov. The submission email must include mandatory criteria, business, and technical proposal documents as separate documents.

SECTION B – SUPPLIES OR SERVICE AND PRICE / COST

B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

This acquisition will allow BARDA to invest Project Bioshield funds for late‐stage clinical development, regulatory approval for intranasal nalmefene as a drug/device combination product to treat opioid, including fentanyl, overdose in pediatric populations; 3‐year stability study to support shelf‐life extension; real world effectiveness study versus naloxone; and procurement of finished, packaged intranasal nalmefene drug device product held as vendor managed inventory.

B.1.1. Definitions

Dose ‐ means an adult or pediatric therapeutic dose of the pharmaceutical product and not a multi‐dose package. The finished product shall be packaged as single‐ or multi‐unit doses, in approved packaging, to provide for cost‐effective product lifecycle value and performance, and to allow for ease of distribution and use during a declared emergency.

Unit ‐ means one drug‐device combination.

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).

B.2. PERIOD OF PERFORMANCE

Prices: The final contract will contain the price/cost provisions agreed upon by the Government and the Offeror. It is anticipated that the final contract will consist of a base period of performance up to five (5) years and a total contract period of performance (base plus option periods) up to 10 years with the exercise of options.

Period of Performance: This requirement has a five‐year base period and ten 12‐month option periods. The total period of performance will not exceed 120‐months.

B.2.1. BASE PERIOD CLINs

CLINs Anticipated Period of Performance

CLIN Type Quantity Supplies/Services

2023‐2028 (Base Period)

0001 Cost Plus Fixed Fee N/A Program Management

• Pediatric study

• Regulatory activities to support FDA approval of pediatric indication

Real World Effectiveness (RWE) study

2023‐2028 (Base Period)

0002 Cost Plus Fixed Fee N/A 3‐year Stability Study

2023‐2024 (Option 1)

0003 Firm Fixed Price 200,000 Procurement of Adult Drug Device Units

2024‐2025 (Option 2)

0004 Firm Fixed Price 200,000 Procurement of Adult Drug Device Units

2025 – 2026 (Option 3)

0005 Firm Fixed Price 200,000 Procurement of Adult and/or Pediatric Drug Device Units

2026 – 2027 (Option 4)

0006 Firm Fixed Price 200,000 Procurement of Adult and/or Pediatric Drug Device Units

2027 – 2028 (Option 5)

0007 Firm Fixed Price 200,000 Procurement of Adult and/or Pediatric Drug Device Units

2028 – 2029 (Option 6)

0008 Firm Fixed Price 200,000 Additional Procurement of Adult and Pediatric Drug Device Units

2029 – 2030 (Option 7)

0009 Firm Fixed Price 200,000 Additional Procurement of Adult and Pediatric Drug Device Units

2030 – 2031 (Option 8)

0010 Firm Fixed Price 200,000 Additional Procurement of Adult and Pediatric Drug Device Units

2031 –2032 (Option 9)

0011 Firm Fixed Price 200,000 Additional Procurement of Adult and Pediatric Drug Device Units

2032 – 2033 (Option 10)

0012 Firm Fixed Price 200,000 Additional Procurement of Adult and Pediatric Drug Device Units

B.2.1.3. Type of Contract:

The Contracting Officer has determined this to be a hybrid Cost Plus Fixed Fee (CPFF) and Firm‐Fixed Priced (FFP) contract type.

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 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, ASPR, 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., ASPR) 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.

a. Person‐in‐Plant With seven (7) days advance notice to the Contractor in writing from the Contracting Officer, the Government may place a person‐in‐plant in the Contractor’s or Subcontractor’s facility, who shall be subject to the Contractor’s or Subcontractor’s policies and procedures regarding security and facility access at all times while in the Contractor’s or Subcontractor’s facility. The Government’s representative shall be provided reasonable access, during normal business hours, to the production areas being utilized in performance on the Contract. As determined by federal law, no Government representative shall publish, divulge, disclose, or make known in any manner, or to any extent not authorized by law, any information coming to him in the course of employment or official duties, while stationed in a contractor’s or subcontractor’s plant.

An article substantially similar to this Person‐in‐Plant article shall be incorporated into any subcontract for experimental or manufacturing work.

b. Security A security plan with proposal submission is required for this effort. See Attachments #15 & #16.

c. 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. 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.

d. Overtime Compensation No overtime (premium) compensation is authorized under the subject contract.

e. Sharing of contract deliverables within United States Government (USG) In an effort to build a robust medical countermeasure pipeline through increased collaboration, the Government may share technical deliverables with Government entities responsible for Medical Countermeasure Development. In accordance with recommendations from the Public Health Emergency Medical Countermeasure Enterprise Review, agreements established in the Integrated Portfolio Advisory Committee (PAC) Charter, and agreements between BARDA and the Department of Defense, the National Institutes of Health, the Centers for Disease Control, and the Food and Drug Administration, BARDA may share technical deliverables and test results created in the performance of this Contract with colleagues within the Integrated Portfolio.

This advanced understanding does not authorize the Government to share financial information outside of the United States Government, except as required by law. The Contractor is advised to review the terms of FAR 52.227‐14, Rights in Data – General, regarding the government’s rights to deliverables submitted during performance as well as the government’s rights to data contained within those deliverables.

f. Approval of Human and Animal Protocols The Contractor shall submit all human and animal protocols and human informed consent documents as referenced under this Contract to the COR for review and approval prior to seeking other approvals (Institutional Review Board, Human Use Committee, Institutional Animal Care and Use Committee) unless the contractor already had such approvals prior to contract award. The Government requires no fewer than eight (8) business days to perform a review. The Contractor shall take this review time into account and submit protocols as early as possible to avoid delays. The Government’s comments and feedback shall be addressed prior to approval. The Contracting Officer’s Representative (COR) will review and provide approval of protocols. Human informed consents shall also be submitted and reviewed with any human protocol.

g. Rights in Data The contract will incorporate the FAR Clause 52.227‐14, Rights in Data—General. The Contractor is advised to review the terms of FAR 52.227‐14, Rights in Data, regarding the government’s rights to deliverables submitted during performance as well as the government’s rights to data contained within those deliverables. The contract will also include FAR Clause 52.227‐16 Additional Data Requirements.

h. Invoice Submission During End of Fiscal Year The government will not accept invoices for processing from Sep 6th through Oct 5th because of end of year fiscal requirements. Any invoices received from September 6th through October 5th will be canceled and returned to the Contractor for resubmission beginning on October 6th.

i. Travel Costs

a) Total expenditures for travel (transportation, lodging, subsistence, and incidental expenses) incurred in direct performance of this contract during the Base Period (CLIN 0001) shall not exceed $XXX (to be determined at the time of award) without the prior written approval of the Contracting Officer. Costs must be consistent with Federal Acquisition Regulations (FAR) 52.247‐63 – Preference for U.S. Air Flag carriers.

b) The Contactor shall invoice and be reimbursed for all travel costs in accordance with Federal Acquisition Regulation (FAR) 31.2 – Contracts with Commercial Organizations, Sub‐Section 31.205‐ 46, Travel Costs.

c) If foreign travel is necessary, a Contracting Officer Authorization (COA) will be required. Expenditures for foreign travel (transportation, lodging, subsistence, and incidental expenses) incurred in direct performance of this contract shall not exceed the amount specified in each approved COA, without the prior written approval of the Contracting Officer. For an organization located outside Canada, the United States and its territories and possessions, foreign travel means travel outside that country. Foreign travel must be billed separately from domestic travel.

Requests for foreign travel must be submitted at least four weeks in advance and shall contain the following:

a. Meeting(s) and place(s) to be visited, with costs and dates; name(s) and title(s) of Contractor personnel to travel and their functions in the contract project;

b. Contract purposes to be served by the travel;

c. How travel of Contractor personnel will benefit and contribute to accomplishing the contract project, or will otherwise justify the expenditure of BARDA contract funds;

d. How such advantages justify the costs for travel and absence from the project of more than one person if such are suggested; and

e. What additional functions may be performed by the travelers to accomplish other purposes of the contract and thus further benefit the project.

j. Option Exercise Following Contractor’s notification to the COR that all Milestones of the current base or option period(s) have been achieved, the Government may, at its sole discretion, exercise its right to award the next option period.

B.4 ORGANIZATIONAL CONFLICT OF INTEREST

a. General: For the purpose of this provision/clause, “consultant” is defined as a company, firm, LLC, sole proprietor, joint venture member, independent contractor, subcontractor, affiliate, or similar entity that is not an employee of the Contractor.

b. Disclosure: The Contractor shall report contacts with consultants who are paid to furnish advice, information, direction, or assistance to the Contractor or any subcontractor in support of the preparation or submission of the Contractor’s business or technical proposal. The report shall include the following information:

a. The name, title, and contact information for the consultant, including the name and contact information for his/her company/firm/etc.

b. The name, title, and contact information for a Contractor point of contact, including the name and contact information for the prime contractor if the consulting services were received by a subcontractor.

c. The nature of the consulting services received.

c. Resolution: The responsible Contracting Officer will review the Contractor’s disclosure to determine whether an actual or appearance of a conflict of interest exists based on the information disclosed by the Contractor and/or from other sources. The framework for the Contracting Officer’s review will be FAR Subpart 9.5, Organizational and Consultant Conflicts of Interest. If an actual or appearance of a conflict of interest exists, the Contracting officer will take action which may include, but is not limited to, requesting a mitigation plan from the Contractor.

B.5. PROVISIONS TO APPLICABLE COSTS

This section prohibits or restricts the use of contract funds which includes the following items (costs unallowable unless otherwise approved by the Contracting Officer):

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

b) Rearrangement or alteration of facilities;

c) Purchase or lease of any item of general purpose office furniture or office equipment regardless of dollar value;

d) Accountable Government Property;

e) Overtime;

f) General scientific meetings/conferences;

g) Travel costs including foreign travel;

h) Costs incurred in the performance of any cost‐reimbursement type subcontract (including consulting agreements);

i) Costs to be paid for the performance of a fixed‐price subcontract that exceeds $250,000.00;

j) Refreshments and Meal Expenditures;

k) Promotional Items;

l) Printing.

SECTION C – DESCRIPTION/SPECIFICATIONS

C.1. STATEMENT OF OBJECTIVES

BACKGROUND AND PURPOSE

This Request for Proposal (RFP) covers the advanced research and development, procurement, and vendor managed inventory (VMI) and delivery of intranasal (IN) nalmefene drug device combination product that has received FDA approval for the treatment of opioid, including fentanyl, overdose, in adult and pediatric populations. Acceptance of the product by the USG requires that the finished product meet all specifications and reliability requirements as determined by the FDA. The goal of this acquisition is to procure IN nalmefene spray that could be used in the prehospital, emergency setting in a mass casualty situation involving opioids to increase the ease and speed of administration. IN nalmefene spray will be FDA approved for adult populations with pediatric approval sought as a

Post‐Marketing Commitment.

Opioid overdose, including fentanyl overdose, remains a significant public health crisis as well as a potential mass casualty threat. Rapid emergency intervention is required to prevent disability and death given the quick onset of life‐ threatening symptoms that manifest within minutes. An opioid receptor antagonist (blocker) drug must be administered as soon as possible to restore breathing and/or consciousness. The current FDA‐approved treatment is naloxone. However, it is anticipated that medical management of fentanyl overdose is better served with a new medical countermeasure that has a longer half‐life better matching that of fentanyl, as administration of shorter acting naloxone can result in renarcotization, or recurring overdose. Clinical trial studies have shown that IN nalmefene may fill this gap. The drug should be available as far forward as practical, in a presentation that allows for ease of use in mass casualty and/or community overdose scenarios. Intranasal sprays fulfill this requirement. Following emergency treatment of community opioid/fentanyl overdoses or mass casualty events, patients could be treated employing medical practices already in use in hospital emergency departments, but local stock can be exhausted in stressed scenarios.

FDA‐approved naloxone intranasal sprays are available, but are not currently stocked by the SNS. There is no current validated requirement for SNS to stockpile or hold in VMI opioid overdose MCMs; however, ASPR is engaged in establishing a requirement for this gap. Due to the need for rapid emergency intervention of opioids, in minutes, not hours, community availability in hospitals and EMS is critical, with SNS or VMI backfill as a mechanism for replenishing stock in a continued response. Taken together, development and procurement of intranasal nalmefene spray (~3 mg) drug device combination product for the treatment of opioid, including fentanyl, overdose, would fulfill the present need in treating a diverse civilian population.

This acquisition will allow BARDA to invest Project Bioshield funds for late‐stage, Phase IV clinical development and pediatric regulatory approval for IN nalmefene spray (as a drug/device combination product) to treat opioid, including fentanyl, overdose in adult and pediatric populations; support a stability study to increase shelf‐life; a real world effectiveness study; and procurement of IN nalmefene spray.

SCOPE

Independently and not as an agent of the USG, the Offeror shall furnish all the necessary services, qualified personnel, materials, supplies, equipment, and facilities not otherwise provided by the USG as needed to perform the work described below.

The USG is seeking to procure and maintain in VMI up to approximately 1,000,000 IN nalmefene spray drug device combination dose units for the treatment of opioid, including fentanyl, overdose over the course of 5 years, and additional procurement of up to 1,000,000 dose units in the following 5 years. IN nalmefene (~3mg) spray shall be maintained in VMI and distributed by the Offeror under this planned procurement. The USG will utilize this procurement of IN nalmefene spray to prepare for mass casualty events involving opioids. IN nalmefene spray shall be

FDA approved as a drug‐device combination product for the treatment of opioid, including fentanyl, overdose, in adults at the time of award. The scope of the base period will include late‐stage, Phase IV activities necessary to support FDA approval of a pediatric indication of IN nalmefene spray as a Post‐Marketing Commitment; a stability study for the drug device combination to support shelf‐life extension; and real world effectiveness study versus naloxone. The product will be procured in stages. The first option period will include initial procurement and VMI, with additional optional

CLINs for procurement and VMI. Five procurement options (Options 1‐5) represent a series of annualized purchases of

IN nalmefene spray drug device combination units and contractor managed VMI with rotation of stock to control product expiry until the entire requirement for the manufacturing and procurement of approximately 1,000,000 units are met with five additional procurement options (Options 6‐10) with VMI totaling 1,000,000 units to reach a total of

2,000,000 units in the contract.

The Contractor shall provide, as part of the Contract, a VMI program for the specified product in which the Contractor shall monitor and maintain, as specified in an inventory management plan, required inventory levels and product shelf‐ life. The Contractor shall 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 the 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 provide, as part of VMI, rotation of stock to control product expiry. 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 Administration for Strategic Preparedness and Response (ASPR) 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. The statement of objectives is outlined in the following sections that the Offeror(s) shall address in their proposed statement of work:

Section 1: Program Management and Risk Mitigation Objectives

Section 2: Late‐Stage Product Development Objectives/Post‐Marketing Commitments and/or Requirements

Section 3: Supply and Delivery of Product Objectives

Section 4: Procurement Objectives

Section 5: Additional Procurement Objectives

SECTION ONE

1. PROGRAM MANAGEMENT AND RISK MITIGATION OBJECTIVES

The Offeror is directed towards details provided in Section F for items below.

1.1. The Offeror shall submit program/risk management documents as described in Section F – Deliveries or

Performance.

1.2. The Offeror shall develop and maintain a risk mitigation plan that is acceptable to the CO and COR. This shall include a risk matrix per Attachment #13. The Offeror shall provide a security plan that is associated with all aspects of manufacture of product, process, storage, and inventory of the IN nalmefene spray product. 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. Security requirements and a template for a Security Plan are included in Attachments #15 and #16, respectively.

1.3. The Offeror submitting a proposal will be required to provide a copy of their facility security plan with their proposal in response to this solicitation. The Offeror is responsible for ensuring all proposed subcontractors provide a facility security plan to be included in the submission.

SECTION TWO

2.1. LATE‐STAGE PRODUCT DEVELOPMENT OBJECTIVES/POST‐MARKETING COMMITMENTS AND/OR

REQUIREMENTS: BASE (CLINs 0001‐0002)

2.1.1. Intranasal nalmefene drug device combination products must demonstrate compliance with FDA reliability standards outlined in the Draft Guidance for Technical Considerations for Demonstrating Reliability of Emergency‐Use Injectors Submitted under a BLA, NDA or ANDA. For more information, visit https://www.fda.gov/regulatory‐information/search‐fdaguidance‐documents/technical‐considerations‐ demonstrating‐reliability‐emergencyuse‐injectors‐submitted‐under‐bla‐nda.

2.1.2. The product shall have an opioid, including fentanyl, overdose indication for use in adult populations at the time of award.

2.1.3. The product shall be FDA approved with a minimum of 12 months stability at the intended storage temperature.

2.1.4. The product shall be manufactured at a scale capable of meeting the USG requirements for stockpiling using VMI.

2.1.5. The Offeror shall commit to comply with Post‐Marketing Commitments and/or Requirements (PMCR) for a pediatric indication as specified by the FDA. Cost estimates may be based on tentative plans in place prior to direction from the FDA.

2.1.6. The Offeror shall commit to conducting an additional stability study of the product to a total of 36 months and seek shelf‐life extension approval from the FDA should the data support it. Cost estimates may be based on tentative plans in place prior to direction from the FDA.

2.1.7. The Offeror shall commit to conducting a Real World Effectiveness study of the product versus naloxone.

Cost estimates may be based on tentative plans in place prior to direction from the FDA.

2.2. REGULATORY OBJECTIVES

2.2.1. The Offeror shall maintain and update, as required by the FDA, all regulatory documentation (Design

History File (DHF), clinical documentation, regulatory binder, etc.) that will be used to support use under FDA approval.

2.2.2. The Offeror shall obtain FDA concurrence on the appropriate path for regulatory evaluation and FDA approval of intranasal nalmefene as a drug‐device combination product, for the treatment of opioid, including fentanyl overdose, in pediatric populations.

2.2.3. The Offeror shall prepare all documentation for and conduct all necessary meetings with the FDA to support submission of post‐marketing commitments/requirements and Phase IV studies outlined in the contract.

2.2.4. The Offeror shall label product in accordance with regulatory requirements from the FDA.

2.2.5. The Offeror shall satisfy any Post‐Marketing Commitments and/or Requirements (PMCR) required for maintaining the approval, including any studies to monitor safety and efficacy during an opioid emergency.

2.3. CLINICAL OBJECTIVES

2.3.1. The Offeror shall conduct all necessary clinical studies to support regulatory approval of intranasal nalmefene drug‐device combination product for the treatment of opioid, including fentanyl, overdose in pediatric populations.

2.3.2. The Offeror shall conduct a Real World Effectiveness study of the intranasal nalmefene drug‐device combination product versus naloxone.

2.3.3. The Offeror shall prepare and submit to BARDA a draft and final Study Report containing 100% quality‐ controlled data and the completion of each clinical study. This report should be prepared in accordance with

FDA and ICH Guidelines.

2.4. CHEMISTRY, MANUFACTURING, CONTROL (CMC) OBJECTIVES

2.4.1. The Offeror shall deliver product with established acceptable product quality attributes meeting the proposed product safety and efficacy during product shelf‐life.

2.4.2. The Offeror shall provide a Manufacturing Plan that includes a facility regulatory compliance plan addressing cGMP standards; description of the manufacturing facility quality assurance and regulatory acceptance including quality systems, validation master plan and regulatory milestones.

2.4.3. The Offeror shall complete quality control activities needed to support continued FDA approval and USG acceptance of product.

2.4.4. The Offeror shall conduct a long‐term stability study of at least 3 years on the intranasal nalmefene drug‐device combination product to support shelf‐life extension.

2.4.5. The Offeror shall demonstrate capability and compliance for all required CMC activities. These include but are not limited to those listed below:

a) Final product manufacturing according to cGMP standards, process and equipment validation of analytical methods and assays appropriate for product characterization and product release, including tests for the identity, purity, potency, and for demonstrating stability of intranasal nalmefene drug device combination product to support ongoing FDA approval. Assure selected materials and vendors are cGMP compliant.

b) Identify a stable source and availability of reagents and reference standards for these assays as required;

execute product stability testing plans as evidenced by available data towards the intended product stability.

c) Develop and maintain documentations such as those describing quality control (QC) and quality assurance

(QA) monitoring plan, manufacturing process, facility information, product storage and monitoring inventory systems, process flow for personnel, material and waste disposal.

d) Package intranasal nalmefene drug device combination product to provide for the most cost‐effective product lifecycle value and performance, and to allow for ease of distribution and use during an emergency.

SECTION THREE

3. SUPPLY AND DELIVERY OF PRODUCT OBJECTIVES (CLINs 0003 ‐ 0012)

3.1 For USG acceptance of IN nalmefene spray drug device combination product, it must be FDA approved in accordance with all federal, state and local regulations, as well as international regulations, if applicable.

During the initial option period, the USG estimates procuring up to 200,000 drug device units, and if all options are exercised, the USG estimates procurement of up to 2,000,000 units total. Offerors must propose price per unit or muti‐unit carton, including required labeling/packaging and delivery into VMI. The source of transportation used by the Offeror for the delivery of product must meet USG security requirements. Product will be delivered to VMI and sites in a manner consistent with FDA guidance for FDA Approved Medical

Products, under section 564 of the Federal Food, Drug, and Cosmetic Act, which was amended by the Project

BioShield Act of 2004 and the Pandemic and All‐Hazards Preparedness Reauthorization Act of 2013. Further guidance can be found at https://www.fda.gov/regulatory‐information/search‐fda‐guidance‐ documents/emergency‐useauthorization‐medical‐products‐and‐related‐authorities .

3.2. The Offeror shall store intranasal nalmefene drug device combination product at their own facility, in compliance with cGMP, until release testing has been completed. The final packaged intranasal nalmefene drug device combination product will be shipped into VMI. The packaging shall be the same as a commercial product.

3.3. The Offeror shall maintain cGMP compliance and quality control of stored intranasal nalmefene drug device combination product in VMI and stability assays to ensure expiry dating for the duration of the contract, and rotation of product to prevent expiry. A minimum of 6‐months remaining on product shelf‐life at the time of product release/deployment from VMI is required. The Offeror shall maintain cGMP compliance and quality control of intranasal nalmefene drug device combination product at all stages of shipping.

3.4. The VMI program shall include storage, holding, inventory management, quality control, stock rotation, secure safe keeping, and possible deployment of product. An inventory management plan shall include a plan to provide the USG with an accurate inventory of product as well as location(s) should USG have an immediate need for product in an emergency situation. While a strategy for deployment of product shall be provided as an example in the Offeror's product delivery plan, the Quality Agreement with ASPR that includes product delivery as needed by the government shall be negotiated after award to align with the USG’s specific product use during a mass casualty event. Descriptions of product transfer will be specified in a Quality Agreement between HHS/ASPR and the Offeror.

SECTION FOUR

4. PROCUREMENT OBJECTIVES (OPTIONs CLINs 0003 ‐ 0007)

4.1. The Offeror shall demonstrate that they can manufacture prefilled intranasal nalmefene drug device combination product that are considered approvable according to FDA guidance and regulation for the treatment of opioid, including fentanyl, overdose in adult and pediatric populations.

SECTION FIVE

5. ADDITIONAL PROCUREMENT OBJECTIVES (OPTIONs CLINs 0008 ‐ 0012): Additional procurement is anticipated.

5.1. The Offeror shall demonstrate that they can manufacture prefilled intranasal nalmefene drug device combination product that are considered approvable according to FDA guidance and regulation for the treatment of opioid, including fentanyl, overdose in adult and pediatric populations.

C.2. PRODUCT REQUIREMENTS

This product shall be held in VMI, 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, 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 ASPR and the Contractor.

The finished drug device combination product shall be packaged as a single unit or multi‐dose, or other approved packaging to provide for cost‐effective product lifecycle 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 to exercise or to not exercise an option. 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 the deadline for exercising an option, if the next option period will not be exercised.

C.2.1. VMI requirements Within 15‐days of awarding Option 1, 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, 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.

Within 30‐days of the signing of Option 1 on 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.

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.

The Contractor shall be responsible to notify the CO and COR within 24‐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.

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.

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.

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.

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 the 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 and/or drug‐device combination product.

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.

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

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.

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., 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.

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.

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 VMI.

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.

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.

Upon expiration or termination (including partial termination) of this Contract, the USG may affect 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.2.3. 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.

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

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.