Skin_Substitutes_Solicitation.pdf

PAGES

15A. NAME

AND

ADDRESS

OF

OFFEROR

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

(Date) (Hour)

CALENDAR DAYS

14. ACKNOWLEDGMENT OF AMENDMENTS

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

(Type or Print)

PAGES

(Date) (Hour)

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

CALENDAR DAYS

14. ACKNOWLEDGMENT OF AMENDMENTS

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

15A. NAME

AND

ADDRESS

OF

OFFEROR

(Type or Print)

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

PREVIOUS EDITION IS UNUSABLE Prescribed by GSA

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

UNDER DPAS (15 CFR 700)

RATING

PAGE OF

1 102

2. CONTRACT NO.

N/A

3. SOLICITATION NO.

15-100-SOL-00018

4. TYPE OF SOLICITATION

SEALED BID (IFB)

X NEGOTIATED(RFP)

5. DATE ISSUED

June 26, 2015

6. REQUISITION/PURCHASE

NO.

N/A

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

HHS/OS/ASPR/AMCG

200 C Street SW Washington, DC 20024

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

SOLICITATION

9. Sealed offers in original and 0 copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if handcarried, in the depository located in See Section L for Instructions until 1:00 PM local time July 27, 2015

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

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

10. FOR INFORMATION

CALL:

A. NAME

Christopher Scott

a. TELEPHONE (NO COLLECT CALLS)

(202) 205-8580

b. E-MAIL ADDRESS

Christopher.Scott@hhs.gov

11. TABLE OF CONTENTS

((x) DESCRIPTION (x) DESCRIPTION

PART I – THE SCHEDULE PART II – CONTRACT CLAUSES

X A SOLICITATION/CONTRACT FORM 01 X I CONTRACT CLAUSES 38

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

X C DESCRIPTION/SPECS./WORK STATEMENT 06 X J LIST OF ATTACHMENTS 48

X D PACKAGING AND MARKING 13 PART IV – REPRESENTATIONS AND INSTRUCTIONS

X E INSPECTION AND ACCEPTANCE 14 REPRESENTATIONS, CERTIFICATIONS, AND

X F DELIVERIES OR PERFORMANCE 15 X OTHER STATEMENTS OF OFFERORS 49

X G CONTRACT ADMINISTRATION DATA 24 X L INSTRS., CONDS., AND NOTICES TO OFFERORS 53

X H SPECIAL CONTRACT REQUIREMENTS 27 X M EVALUATION FACTORS FOR AWARD 64

OFFER (Must be fully completed by Offeror)

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

12. In compliance with the above, the undersigned agrees, if this offer is accepted within ___ 120__calendar days (120 calendar days unless a different period is inserted 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 designated point(s), within the time specified in the schedule.

13. DISCOUNT FOR PROMPT PAYMENT

(See Section I, Clause No. 52-232-8)

10 CALENDAR DAYS

20 CALENDAR DAYS

30 CALENDAR DAYS

AMENDMENT NO. DATE AMENDMENT NO. DATE

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

15B. TELEPHONE NO.

AREA CODE NUMBER EXT.

15C. CHECK IF REMITTANCE ADDRESS

IS DIFFERENT FROM ABOVE - ENTER

SUCH ADDRESS IN SCHEDULE.

17. SIGNATURE

18. OFFER DATE

AWARD (To be completed by Government)

19. ACCEPTED AS TO ITEMS NUMBERED 20. AMOUNT

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

21. ACCOUNTING AND APPROPRIATION

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

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

(4 copies unless otherwise specified)

ITEM

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

26. NAME OF CONTRACTING OFFICER (Type or print)

27. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

28. AWARD DATE

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

FAR (48 CFR) 53.214©

K

NOTE TO OFFERORS

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

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

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

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

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

The cutoff date for all questions on this RFP is Monday July 06, 2015 until 1PM EST. All questions shall be submitted via e-mail to Christopher.scott@hhs.gov.

PART I – THE SCHEDULE

SECTION B – SUPPLIES OR SERVICE AND PRICE / COST

Cell-Based Skin Substitutes for Definitive Care of Burn Injuries

B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The Biomedical Advanced Research and Development Authority (BARDA) has a need to effectively treat and ameliorate the effects of burn injuries resulting from the detonation of a nuclear device. Treatment and care for burn injuries is labor intensive and influenced by the unique properties of each case with complicating factors including patient age and health as well as burn area and depth. The challenges of providing definitive burn care are heightened when delivering treatment after a mass casualty event in a resource strained environment. The number of patients generated by a mass casualty event will create bottlenecks in the ability to provide quality treatment and care for victims. In an effort to address the additional complications commensurate with a mass casualty event, BARDA has worked with the burn care community to identify those key procedures that can be improved to mitigate the consequences of an event generating burn victims. The two major areas where enhanced treatment options could provide a meaningful difference are in the initial care and triage of patients and secondly, in the long term treatment and recovery steps of burn care. The focus of this solicitation is to address the long term treatment and recovery steps of burn care.

Cell-based skin substitutes requiring a single surgical application (in lieu of autografting) would increase treatment capacity to provide definitive wound closure to burn injuries. The use of skin substitutes particularly during public health emergencies could potentially reduce the time, labor, and resource burdens associated with standard of care. This would free up resources to enable treatment for more patients. Highly desirable skin substitutes are those which are fully resorbable, facilitate definitive wound closure of partial thickness and even full thickness burn wounds, and require no additional surgical procedures after placement on the excised burn wound.

Under this Request for Proposal (RFP), BARDA is seeking to fund late-stage development and procurement of cell-based skin substitutes that can enhance the capacity to provide definitive care for thermal burn injuries. A key potentially desirable attribute of cell-based skin substitutes may be to reduce or eliminate the need for autografting and thereby increase the efficiency of burn care by promoting faster burn wound healing and recovery. Autograft-sparing products will not be considered as a possible solution under this category of products. The late stage development and procurement of autograft-sparing products is the subject of RFP# 15-100-SOL- 00019. All candidate products shall at a minimum be in active clinical Phase II study or pilot study for devices with data available to support the intended use as a cell-based skin substitute for treatment of deep partial and /or full thickness skin burn injuries. Products are to be procured in sufficient quantities at the discretion of the USG to enable an effective emergency response under Emergency Use Authorization or upon the Food and Drug Administration’s (FDA) approval.

B.2. PRICES / COSTS

The final contract will contain the price/cost provisions agreed upon by the Government and the Contractor. It is anticipated that the final contract will be a five year (5) contract which contains a base period of five years (60 months) and three (3) potential options for additional quantities to be potentially exercised within the base period during the life of the contract. Below are the anticipated Contract Line Item Numbers (CLINs). The final contract will contain CLINs agreed upon by the Government and the Contractor.

B.2.1. BASE PERIOD OF PERFORMANCE: The base period will be from ________ to ________.

B.2.1. ESTIMATED COST AND FIXED FEE

Base Period Cost Reimbursement CLINs

Item Supplies/Services Estimated Cost

Fixed Fee

Cost + Fixed Fee (CPFF)

0001 (Base) Licensure, approval, and clearance of product through the FDA

TBD TBD TBD

0004 (Base) Pediatric Studies (This is an option that may or may not be exercised during the base period for expansion of the label indication with guidance from the FDA)

TBD TBD TBD

B.2.2. FIRM FIXED PRICE

Base Period Fixed Price CLINs

Item Supplies/Services Units (# of Product)

Unit Price ($)

Total ($)

(Option Quantity)

Initial purchase, storage, and delivery of product

TBD TBD TBD

(Option Quantity)

Surge Capacity – Additional procurement of product (This is an option that may or may not be exercised during the base period due to product demand or unforeseen medical emergencies)

TBD TBD TBD

Item Supplies/Services Total ($)

(Option Quantity)

Phase IV post marketing commitments /Requirements (This is an option that may or may not be exercised during the base period as determined by the need and as established by the FDA)

TBD

B.3. ADVANCE UNDERSTANDINGS

The final contract may contain advance understandings between the Government and the Contractor.

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.4. 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 of 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 $150,000.00;

j) Refreshments and Meal Expenditures;

k) Printing

SECTION C – DESCRIPTION/SPECIFICATIONS/WORKSTATEMENT

C.1. STATEMENT OF OBJECTIVES

1. Background and Purpose

BARDA has a need to effectively treat and ameliorate the effects of burn injuries resulting from detonation of a nuclear device. Treatment and care for burn injuries is labor intensive and influenced by the unique properties of each case with complicating factors including patient age and health as well as burn area and depth. The challenges of providing definitive burn care are heightened when delivering treatment after a mass casualty event in a resource strained environment. The number of patients generated by a mass casualty event will create bottlenecks in the ability to provide quality treatment and care for victims. In an effort to address the additional complications commensurate with a mass casualty event BARDA has worked with the burn care community to identify those key procedures that can be improved to mitigate the consequences of an event generating burn victims. The two major areas where enhanced treatment options could provide a meaningful difference are in the initial care and triage of patients and secondly, in the long term treatment and recovery steps of burn care. The focus of this RFP is to address the long term treatment and recovery steps of burn care.

Under this RFP, BARDA plans to support late stage development and acquire medical countermeasures to address the recovery and healing of burn victims. These treatments will enhance the capacity of burn care specialists to rapidly and effectively treat thermal burn skin injuries. This Statement of Objective (SOO) focuses on allogenic skin substitutes.

For the purposes of this RFP, the following definition of skin substitute by the American Burn Association’s publication “Surgical Management of the Burn Wound and Use of Skin Substitutes,” 2009, has been used. Accordingly, a "skin substitute" is defined as, “a biomaterial, engineered tissue or combination of materials and cells or tissues that can be substituted for skin autograft or allograft in a clinical procedure".

Discussions within the professional burn community and market research data indicates that synthetic allogenic cell based skin substitutes can provide an advantage in effective burn care by promoting healing and recovery of severe burn injuries. Cell based skin substitutes have the potential to reduce the need and/or serve as an alternative to autografting, a painful and highly specialized procedure which involves removal of skin from an uninjured area of the patient’s body to replace the skin damaged by burn. The burnt area of the skin must be removed carefully via a surgical procedure followed by surgical grafting of the healthy skin removed from an uninjured location. The autografting procedure is labor-intensive, requires training, is time consuming and invokes additional risk to the patient due to the operative procedures at multiple sites. In mass casualty scenarios involving significantly high numbers of burn patients, the burn care medical community could not deliver adequate attention and care using current medical practices.

2. Scope:

The USG will support late stage development and procurement of cell-based skin substitutes. A key potentially desirable attribute of cell-based skin substitutes is to reduce or eliminate the need for autografting and thereby increase the efficiency of burn care by promoting faster burn wound healing and recovery. These products are expected to enhance the ability of the USG to respond to a sudden surge in burn care needs after a mass casualty event and will improve the current standard of definitive burn care in the long term.

In order to meet this scope, the objectives are outlined in the following six sections that the Contractor shall address in their proposal:

Section 3: Late stage Product Development Objectives (Licensure, approval, or clearance of product through FDA)

Section 4: Procurement, Storage, or Delivery of Product Objectives

Section 5: Program Management Objectives

Section 6: [Contract Option] Post-Marketing Commitments and/or Requirements

Section 7: [Contract Option] Pediatric Studies

Section 8: [Contract Option] Additional Procurements

Proposals from Contractors would be evaluated in the ability to meet these objectives as described below.

3. Late stage Product Development Objectives

Independently, and not as an agent of the USG, the Contractor shall furnish all the necessary services, qualified personnel, materials, supplies, equipment, facilities, transportation and travel not otherwise provided by the USG as required to fulfill the programmatic objectives.

3.1. General Product Development Objectives

3.1.1. The product shall at a minimum be in active clinical Phase II study or pilot study for devices with data available to support the intended use as a cell-based skin substitute for treatment of deep partial and /or full thickness skin burn injuries. It is possible the FDA may request separate clinical trials for deep partial and full thickness indication. The Contractor shall present sufficient non-clinical and clinical study data to support the use of the product per its intended indication under discussion with the FDA.

3.1.2. The product shall have the potential for use in both adults and special populations (e.g.

pediatrics, immunocompromised, elderly). However, it would be acceptable for the Contractor with product under development to have a plan for addressing the needs for special populations.

3.1.3. The Contractor must define how the proposed product will enhance the readiness of the medical community to treat burn patients in mass casualty event. Enhanced readiness can be evaluated by the ability of the product to address the potential desirable attributes in three areas listed below:

- Decrease resource burden and increase throughput

- Improve patient outcome

- Product sustainability

It is anticipated that a product may not have the ability to meet all desirable attributes. The Contractor is encouraged to provide a clear, candid and justifiable response especially when direct evidentiary data is not available.

3.1.3.1. Decrease Resource Burden and Increase Throughput:

3.1.3.1.1. Decrease in the length of hospital stay as compared to standard of care

(SOC).

3.1.3.1.2. Reduction in the needs for surgical infrastructure resources (e.g., need for operating room v/s treatment at bedside)

3.1.3.1.3. Reduction in the need for surgical personnel trained for burn care.

3.1.3.1.4. Reduction in the need for labor associated with the autografting (e.g., fewer personnel, shortens a standard of care (SOC) procedure)

3.1.3.2. Improve Patient Outcome:

3.1.3.2.1. Reduction in patient morbidity and use of pain medication.

3.1.3.2.2. Acceleration of wound closure and healing when compared to SOC.

3.1.3.2.3. Improved functional and /or cosmetic outcome.

3.1.3.3. Product Sustainability

3.1.3.3.1. Integration of product into current procedures and compatible with current clinical skills.

3.1.3.3.2. Potential to reduce the overall cost of burn care for the patient.

3.1.3.3.3. Other potential applications for the product in commercial marketplace and its development status.

3.1.4. As part of the clinical evaluation plan for the product, the Contractor shall conduct a pharmoco-economic analysis of the treatment to assess the impact on the cost of care compared to the alternative or standard of care in an effort to demonstrate the value proposition in burn care.

3.1.5. The Contractor must demonstrate applicability of their product for other indications in the commercial market sector and the status.

3.1.6. The Contractor shall provide a draft Target Product Profile (TPP) which will be further developed through discussion and negotiation with BARDA and / or FDA. Guidance to the industry is available at FDA TPP Guidance to industry:

http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidance s/ucm080593.pdf

3.2. Regulatory, Non-Clinical, and Clinical Objectives

3.3.

3.3.1. The Contractor shall submit a Quality Management System (QMS) plan.

3.3.2. The Contractor shall provide a clear and comprehensive regulatory master plan for obtaining product licensure. The plan must include risk evaluation and address outstanding items identified by FDA (toxicology, non-clinical and clinical studies, and manufacturing activities). The appropriate milestones for regulatory activities must be included the overall Gantt chart.

3.3.3. The Contractor shall inform BARDA of all communications with the FDA for this specific product.

3.3.4. The Contractor will be responsible for generating the data to support USG filing of a Pre-

Emergency Use Authorization (Pre-EUA) package for use of the product during a declared emergency, declared potential emergency or identification of material threat under an Emergency Use Authorization (EUA). For information concerning EUA, please consult http://www.fda.gov/RegulatoryInformation/Guidances/ucm125127 and http://www.fda.gov/EmergencyPreparedness/Counterterrorism/MedicalCountermeasures/M CMLegalRegulatoryandPolicyFramework/ucm182568.htm http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm080593.pdf http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm080593.pdf http://www.fda.gov/EmergencyPreparedness/Counterterrorism/MedicalCountermeasures/MCMLegalRegulatoryandPolicyFramework/ucm182568.htm http://www.fda.gov/EmergencyPreparedness/Counterterrorism/MedicalCountermeasures/MCMLegalRegulatoryandPolicyFramework/ucm182568.htm

The information and data needed to support the Pre-EUA package will be determined by FDA. The Contractors shall note that the submission to support potential use under an emergency will be submitted by BARDA or the CDC/SNS, and the Contractor(s) shall be obligated to supply BARDA or the CDC/SNS with the data needed to support such a submission, including a right of reference to the Contractor's Investigational New Drug (IND) or other application that contains the supporting data.

3.3.5. The Contractor shall address any FDA comments on pre-EUA package as applicable.

The Contractor shall maintain and update, as required by the FDA, all required regulatory documentation (investigator brochure, regulatory binder, etc.), that will be used to support use under EUA and approval/licensure.

3.3.6. The Contractor shall conduct all clinical studies trials in compliance with all applicable local, state and federal rules and regulations as well as FDA guidance.

3.4. Chemistry, Manufacturing, Control (CMC) Objectives

3.4.1. The Contractor(s) shall describe their capability to manufacture using a well-controlled process (which could be validated) in accordance with current Good Manufacturing Practice (cGMP) to manufacture up to 680 m of skin substitute Final Dosage Product

(FDP).

3.4.1.1. Contractor shall provide their current operational capacity.

3.4.1.2. Contractor shall provide a plan to achieve the desired capacity to manufacture up to 680 m of skin substitute FDP and the time-frame necessary to achieve the capacity.

3.4.1.3. For products in development, Contractors shall provide data from all GMP lots used in Phase II and Phase III clinical studies as appropriate.

3.4.1.4. If appropriate, the Contractor shall demonstrate capability for manufacturing scale-up leading to consistency lots and commercial manufacturing for the product.

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

3.4.2.1. Final product manufacturing, process & equipment validation, analytical methods and assays appropriate for product characterization and product release, including tests for the identity, purity, potency, and for demonstrating stability of the intermediate and FDP as appropriate.

3.4.2.2. Identify a stable source and availability of reagents and reference standards for these assays required; execute product stability testing plans as evidenced by available data towards the intended product stability.

3.4.2.3. Other documentations such as those describing quality control (QC) and quality assurance (QA) monitoring plan, and manufacturing process, facility information, product storage and monitoring inventory systems, process flow for personnel, material and waste disposal.

3.4.2.4. Packaging of FDP 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.

4. Procurement, Storage, or Delivery of Product Objectives

The USG is seeking product availability to treat deep-partial and/or full-thickness skin burn injuries up to a total amount equivalent to 680 m of injured skin surface area. Products considered for procurement may be either of the following:

4.1. A FDA approved product, or;

4.2. A product that is sufficiently advanced on the developmental pathway for procurement under PBS (see 3.1.1) at the discretion of the USG based on sufficient data to support its potential use during a declared emergency under EUA.

4.3. For the purpose of procurement, the Contractor’s proposal and SOW shall address the following areas:

4.3.1. Product availability for procurement up to 680 m

. The USG has the sole discretion to determine the amount of product to procure based upon the Contractor’s proposal and availability of funds.

4.3.2. A production plan and timeline that describes the facilities, processes, resources and capabilities necessary to manufacture product under normal market conditions.

4.3.3. To support a rapid ramp up product manufacturing capacity during public health emergencies, the Contractor shall provide a Surge Capacity production plan and timeline.

The Surge Capacity production plan shall describe the processes, resources and capabilities necessary and would be in alignment with plan provided in response to section 3.3.1.2.

4.3.4. A cGMP compliant storage and stability plan that describes the methodology for long term storage, shelf life extensions, labeling and re-labeling requirements, inventory management and processes that minimize or eliminate loss due to expiry. Product may be stored at the Contractor’s site in a Vendor-Managed Inventory (VMI) or a Centers for Disease Control (CDC) designated location. In any case, the Contractor shall be responsible to ensure compliance of any asset under storage.

4.3.5. The Contractor shall describe in sufficient detail the management of the cGMP-compliant storage under VMI.

4.4. Advanced Understanding: A Quality Agreement with the CDC will be necessary upon contract award. The Quality Agreement shall outline the responsibilities of both the Contractor and the USG (i.e., CDC/SNS–Quality Control and BARDA) for event-driven product shipping, receiving, and custody by the CDC/SNS. These documents shall be drafted and signed by all parties prior to the transport and custody of the product under the VMI/DMI or the CDC/SNS.

The Contractor shall demonstrate commitment to adherence with these principles in the proposal.

5. Project Management & Risk Mitigation Objectives

The Contractor is also directed towards details provided in section on Reporting Requirements (see section F for guidance on items below).

5.1. Integrated Master Plan and Earned Value Management

5.1.1. The Contractor shall provide an Integrated Master Project Plan (including tabular and

Gantt forms) to BARDA that clearly indicates the critical path to support product approval.

The Integrated Master Project Plan shall outline key, critical path milestones, with "Go/No Go" decision criteria and a contract Work Breakdown Structure (due within 90 days of contract award with updates as requested by the COR).

5.1.2. The Contractor shall submit an updated Integrated Master Schedule in an approved format.

5.1.3. The Contractor shall use principles of Earned Value Management System (EVMS) in the management of this contract.

5.1.4. The Contractor shall submit a plan for a Performance Measurement Baseline Review

(PMBR).

5.2. Risk Management Objectives

5.2.1. The Contractor shall develop and maintain a risk management plan.

5.2.2. The Contractor shall participate in regular meetings to coordinate and oversee the contracting effort.

5.2.3. The Contractor shall provide a list of individuals to serve as primary and secondary points of contact who will be available 24 hours a day, seven days a week, to be notified in case of a public health emergency.

5.2.4. The Contractor shall provide a security plan which is associated with all aspects of manufacture of product, process, storage, and inventory of the FDP including when procured for use under EUA and intended for delivery to the CDC/SNS.

6. [Option] Post-Marketing Commitments and/or Requirements:

6.1 The Contractor shall commit to comply with Post-Marketing commitments and/or Requirements

(PMCR) as specified by the FDA. For products approved by the FDA, Contractor shall provide a current plan to address the PMCR.

7. [Option] Pediatric Studies:

7.1 The Contractor shall commit to comply with conducting studies for evaluation of the product in pediatric population as specified by the FDA. With the intent to initiate studies when appropriate and allowed by the FDA, the Contractor shall provide a draft pediatric clinical plan with a study design.

8. [Option] Surge Capacity:

8.1. To maintain preparedness, the USG shall at its discretion execute optional additional procurements either to the maintain product inventory (replenishment) or procure additional product to treat deep-partial and/or full-thickness skin burn injuries covering up to 2000 m of skin surface area. These additional procurements shall include information in a tabular format with cost and schedule for procurement in 100 m increments (see applicable conditions in section 4.3).

8.2. The USG has the sole discretion to determine the amount of product to be procured for any purpose based on availability of funds.

C.2. REPORTING REQUIREMENTS

See Section F for specific reporting requirements.

Performance of the contract will be monitored by the CO/COR on a regular basis. The Contracting Officer will be responsible for inspection and acceptance of deliverables and services. Monitoring of the contract will be based on periodic reporting by the Contractor.

C.3. MEETINGS/SITE VISITS

The Contractor and BARDA shall participate in regular meetings to coordinate and oversee the contracting effort as requested by the Contracting Officer (CO)/Contracting Officer’s Representative (COR). Such meetings may include, but are not limited to, a kickoff meeting to be held at a location determined by the COR, status update meeting or teleconferences, site visits to the Contractor’s and/or subcontractor’s facilities, and meetings with individual Contractors and other HHS officials to discuss the technical, regulatory, and ethical aspects of the program. The Contractor shall provide data, reports, and presentations to groups of outside experts and USG personnel and USG-contracted subject matter experts as required by the CO/COR facilitating review of activities.

The purpose of the kickoff meeting will be to orient the Contractor to HHS/BARDA and review contract requirements. This meeting usually occurs within a month after contract award.

Expect Bi-weekly or monthly status update meetings/teleconferences. The schedule for these meetings will be established by the CO and COR.

Periodic site visits will occur on an adhoc basis (At least twice a year)

FDA Audits Within thirty (30) calendar days of an FDA audit of Contractor or subcontractor facilities, the Contractor shall provide copies of the audit findings, final report, and a plan for addressing areas of nonconformance to FDA regulations and guidance for GLP, GMP or GCP guidelines as identified in the final audit report.

Other U.S. Government Audits The United States Government (USG) reserves the right to conduct an audit of the Contractor with 48 hours advance notice. The USG reserves the right to accompany the Contractor on routine and for-cause site-visits/audits of subcontractor. At the discretion of the USG and independent of testing conducted by the Contractor, BARDA reserves the right to conduct site visits/audits and collect samples of product held by the Contractor and subcontractors.

Pre-award site visits may be made with short notice. Contractors are expected to guarantee the availability of key staff or other staff determined by the Government as essential for purposes of this site visit.

SECTION D – PACKAGING, MARKING AND SHIPPING

D.1. METHOD OF DELIVERY

Unless otherwise specified by the Contracting Officer, all deliverable items to be furnished to the Government under this contract (including invoices) shall be made by first class mail, overnight carrier, or email as described in SECTION F.3.

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and Contractor’s name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

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 a duly authorized representative. Technical inspection and acceptance will be take place at:

Biomedical Advanced Research and Development Authority Office of the Assistant Secretary for Preparedness and Response 330 Independence Avenue, S.W.

Room G640 Washington, D.C. 20201

Acceptance may be presumed unless otherwise indicated in writing by the Contracting Officer or the duty authorized representative 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 52.246-4, Inspection of Services - Fixed Price (August 1996)

FAR 52.246-5, Inspection of Services - Cost-Reimbursement (April 1984)

FAR 52.246-9, Inspection of Research and Development (Short Form) (April 1984)

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

SECTION F – DELIVERIES OR PERFORMANCE

F.1. PERIOD OF PERFORMANCE

The period of performance of this contract is anticipated for sixty (60) months from the date of award. The period of performance may be extended with the exercise of option(s), structured as CLINs, 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 their duly authorized representative.

F.3. CONTRACT DELIVERABLES AND REPORTING REQUIREMENTS

F.3.1. Submission of Contract Deliverables

Documents shall be delivered electronically via email to the Contracting Officer (CO) and the Contracting Officer’s Representative (COR). Unless otherwise specified by the Contracting Officer all deliverables and reports furnished to the Government under any potential resultant contract (including invoices) shall be addressed as follows:

UPS/FedEx/Courier USPS Mail Packages

Contracting Officer

HHS/ASPR/AMCG

200 C St. SW Washington, DC 20024 Email: TBD

Contracting Officer

HHS/ASPR/AMCG

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

UPS/FedEx/Courier USPS Mail Packages

Contracting Officer Representative

HHS/ASPR/BARDA

200 C St. SW Washington, DC 20024 Email: TBD

Contracting Officer Representative

HHS/ASPR/BARDA

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

F.3.2. Reporting Requirements

In addition to those reports required by other terms of this RFP, the Contractor shall submit to the CO and the COR technical progress reports as identified in any potential resultant contract. These reports shall be subject to the technical inspection and requests for clarification by the COR. These reports shall be brief, factual, and prepared in accordance with the following format:

A. Monthly Progress Report

This report shall include a description of the activities during the reporting period and the activities planned for the ensuing reporting period. The first reporting period consists of the first full month of performance plus any fractional part of the initial month. Thereafter, the reporting period shall consist of each calendar month.

The Contractor shall submit a Monthly Progress Report on or before the 15th calendar day following the last day of each reporting period and shall include the following:

Title Page: The title page for this report shall include the contract number and title; the type of report and period that it covers; the Contractor's name, address, telephone number, fax number, and e-mail address; and the date of submission.

Distribution List: A list of individuals receiving the Technical Progress report.

Progress:

SECTION I - An introduction covering the purpose and scope of the contract effort.

SECTION II Part A: SUMMARY - A description or table summarizing ongoing activities.

SECTION II Part B: MANAGEMENT AND ADMINISTRATIVE UPDATE – This section shall include a description of all meetings, conference calls, etc. that have taken place during the reporting period. Include progress on administration and management issues (e.g. evaluating and managing subcontractor performance and personnel changes). Please include all Quality Management System, Quality Control, and Quality Assurance Plans as part of this report or as requested by the COR.

SECTION II Part C: TECHNICAL PROGRESS – This section shall document the results of work completed and costs incurred during the period covered in relation to the proposed progress, effort, and budget. The report shall be in sufficient detail to explain comprehensively the results achieved.

SECTION II Part D: ISSUES – This section shall include a description of problems encountered and proposed corrective action; differences between planned and actual progress; why the differences have occurred and what corrective actions are planned; and if a project activity is delinquent, then what corrective action steps are planned. Revised timelines shall be provided.

SECTION II Part E: PROPOSED WORK – This section shall include a summary of work proposed as a rolling three (3) month forecast for the next reporting period, by a certain date, and by whom.

SECTION II Part F: MANUFACTURING AND SUPPLY CHAIN MANAGEMENT – This section shall include a summary of the manufacturing and supply-chain related activities. Also include in this section updates to the production plan, capacity projections, stability results, inventory and shipment/distribution information.

Invoices: Summary of any invoices submitted during the reporting period.

A Monthly Progress Report will not be required in the same month Annual or Final Technical Progress Reports are due.

B. Annual Progress Report

This report shall include a summation of the activities during the reporting period, and the activities planned for the ensuing reporting period. The first reporting period consists of the first full year of performance plus any fractional part of the initial year. Thereafter, the reporting period shall consist of each calendar year.

The Contractor shall submit an Annual Progress Report on or before the 30th calendar day following the last day of each reporting period and shall include the following:

Title Page: The title page for this report shall include the contract number and title; the type of report and period that it covers; the Contractor's name, address, telephone number, fax number, and e-mail address; and the date of submission.

Distribution List: A list of individuals receiving the Technical Progress report.

SECTION I - An introduction covering the purpose and scope of the contract effort.

SECTION II Part A: SUMMARY - A description or table summarizing ongoing activities.

SECTION II Part B: MANAGEMENT AND ADMINISTRATIVE UPDATE – This section shall include a description of all meetings, conference calls, etc. that have taken place during the reporting period. Include progress on administration and management issues (e.g. evaluating and managing subcontractor performance and personnel changes). Please include all Quality Management System, Quality Control, and Quality Assurance Plans as part of this report or as requested by the COR.

SECTION II Part C: TECHNICAL PROGRESS – This section shall document the results of work completed and costs incurred during the period covered in relation to proposed progress, effort, and budget. The report shall be in sufficient detail to explain comprehensively the results achieved.

SECTION II Part D: ISSUES – This section shall include a description of problems encountered and proposed corrective action; differences between planned and actual progress; why the differences have occurred and what corrective actions are planned; and if a project activity is delinquent, then what corrective action steps are planned. Revised timelines shall be provided.

SECTION II Part E: PROPOSED WORK – This section shall include a summary of work proposed as a rolling three (3) month forecast for the next reporting period, by a certain date, and by whom.

SECTION II Part F: MANUFACTURING AND SUPPLY CHAIN MANAGEMENT – This section shall include a summary of the manufacturing and supply-chain related activities. Also include in this section updates to the production plan, capacity projections, stability results, inventory and shipment/distribution information.

Invoices: Summary of any invoices submitted during the reporting period.

An Annual Progress Report will not be required for the period when the Final Technical Progress Report is due.

C. Draft Final Report and Final Report

These reports are to include a summation of the work performed and results obtained for execution of various studies or technical work packages during the entire contract period of performance. This report shall be in sufficient detail to describe comprehensively the results achieved. The Draft Final Progress Report shall be due forty-five (45) calendar days prior to the expiration date of the contract and the Final Progress Report is due no later than 30 days following the expiration date of the contract. The report shall conform to the following format:

Title Page: The title for these reports shall include the contract number and title; the type of report and period that it covers; the Contractor's name, address, telephone number, fax number, and e-mail address; and the date of submission.

Distribution List: A list of individuals receiving the Technical Progress report.

SECTION I: EXECUTIVE SUMMARY - Summarize the purpose and scope of the contract effort including a summary of the major accomplishments relative to the specific activities set forth in the Statement of Work.

SECTION II: RESULTS - A detailed description of the work performed and the results obtained including all expenses for the entire contract period of performance.

D. FDA Regulatory Agency Correspondence, Meeting Summaries, and Submissions.

a. Within five business days of any formal meeting with the FDA or other regulatory agency, the Contractor shall forward the initial draft minutes to BARDA. The Contractor shall forward the final minutes when available.

b. Within five business days of any informal meeting with the FDA or other regulatory agency, the Contractor shall forward the initial draft minutes to BARDA. The Contractor shall forward the final minutes when available and if applicable.

c. The Contractor shall forward the dates and times of any meeting with the FDA and other regulatory agencies to BARDA as soon as the meeting times are known and make arrangements for appropriate BARDA staff to attend the meetings.

d. The Contractor shall provide BARDA the opportunity to review and comment upon any documents to be submitted to the FDA or other regulatory agency. The Contractor shall provide BARDA with five (5) business days in which to review and provide comments back to the Contractor prior to the Contractor’s submission to the FDA.

e. The Contractor shall forward Standard Operating Procedures (SOPs) upon request from

COR.

f. The Contractor shall provide raw data and/or specific analysis of data generated with

USG funds upon request from the COR.

g. The Contractor shall notify the Contracting Officer’s Representative and Contracting

Officer within 24 hours of all FDA arrivals to conduct site visits/audits by any regulatory agency. The Contractor shall provide the USG with an exact copy (non-redacted) of the FDA Form 483 and the Establishment Inspection Report (EIR). The Contractor shall provide the Contracting Officer’s Representative and Contracting Officer copies of the plan for addressing areas of non-conformance to FDA regulations for GLP guidelines as identified in the audit report, status updates during the plans execution, and a copy of all final responses to the FDA. The Contractor shall also provide redacted copies of any FDA audits received from subcontractors that occur as a result of this contract or for this product. The Contractor shall make arrangements with the COR for the appropriate BARDA representative(s) to be present during the final debrief by the regulatory inspector.

E. Other Requirements/Deliverables

a. Integrated Master Project Plan

The Contractor shall provide an Integrated Master Project Plan (including tabular and Gantt forms) to BARDA that clearly indicates the critical path to annual deliverables and Work Breakdown Structure (WBS) elements. Attention shall be placed on providing sufficient turnaround time for the USG (BARDA, FDA, and CDC) for review of critical documentation. The Contractor shall integrate to demonstrate interdependencies among all CLINS. The Integrated Master Project Plan shall be incorporated into any potential contract and will be used to monitor performance of the contract. This report shall be due within 90 days of contract award. Updates shall be due as requested by the COR or Co-

COR.

i. Critical Path Milestones

The Integrated Master Project Plan shall outline key, critical path milestones, with “Go/No Go” decision criteria (entrance and exit criteria for each phase of the project). This report shall be due within 90 days of contract award. Updates shall be due as requested by the COR or Co-COR.

ii. Work Breakdown Structure

The USG has provided a Contract Work Breakdown Structure (CWBS) template (See http://www.phe.gov/about/amcg/contracts/Pages/toolkit.aspx) and the Contractor shall further delineate the CWBS to Level 5 as part of their Integrated Master Project Plan. The WBS shall be discernable and consistent. BARDA may require Contractor to furnish WBS data at the work package level or at a lower level if there is significant complexity and risk associated with the task. This report shall be due within 90 days of contract award. Updates shall be due as requested by the COR or Co-COR.

iii. Risk Mitigation Plan/Matrix The Contractor shall develop and maintain a risk management plan that highlights potential problems and/or issues that may arise during the life of the contract, their impact on cost, schedule and performance, and appropriate remediation plans. This plan shall reference relevant WBS/SOW elements where appropriate. The USG has provided a Risk Mitigation Matrix template (See http://www.phe.gov/about/amcg/contracts/Pages/toolkit.aspx) to be completed by any prospective Contractor. This report shall be due within 90 days of contract award. Updates shall be due as requested by the COR or Co-COR.

b. Technology Packages

Technology packages developed under the contract that includes complete protocols must be submitted at the request of the BARDA Contracting Officer’s Representative.

See FAR clauses 52.227-11, Patent Rights-Ownership by the Contractor, and 52.227-14, Rights in Data. This report shall be due upon request from the COR or Co-COR.

c. Experimental Protocols

The Contractor shall submit to the COR all study/experiment/test plans, designs, and protocols prior to execution for BARDA approval or upon request by the COR or Co-COR when required.

d. Annual/Final Invention Report All reports and documentation required by FAR Clause 52.227-11, Patent Rights- Ownership by the Contractor, including, but not limited to, the invention disclosure report, the confirmatory license, and the Government support certification. An Annual Invention Report shall be due on or before the 30 th calendar day after the completion of each reporting period. A Final Invention Report (see FAR 27.303 (b)(2)(ii)) shall be due on or before the expiration date of the contract. If no invention is disclosed or no activity has occurred on a previously disclosed invention during the applicable reporting period, a negative report shall be submitted to the Contracting Officer.

e. Publications

Any manuscript or scientific meeting abstract containing data generated under this contract must be submitted to COR for review prior to submission. Reports shall be due within 30 calendar days for manuscripts and 15 calendar days for abstracts.

http://www.phe.gov/about/amcg/toolkit/Pages/default.aspx

f. Press Releases

The Contractor agrees to accurately and factually represent the work conducted under this contract in all press releases. The Contractor shall ensure the Contracting Officer has received and approved an advanced copy of any press release not less than five (5) business days prior to the issuance of any potential press release.

g. Security Report

The Contractor shall report to the government any activity; or incident that is in violation of established security standards; or indicates the loss or theft of government products.

Reports shall be due within 24 hours after occurrence of an activity or incident.

F. Earned Value Management System Plan

a. Earned Value Management System Plan:

Subject to the requirements under HHSAR Clause 352.234-3, the Contractor shall use principles of Earned Value Management System (EVMS) in the management of this contract (include this plan as part of the monthly, annual, and final reports). The Seven Principles are:

I. Plan all work scope for the program to completion.

I…