75A50121R00018.pdf

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

UNDER DPAS (15 CFR 700)

RATING PAGE OF PAGES

2. CONTRACT NUMBER 3. SOLICITATION NUMBER 4. TYPE OF SOLICITATION 5. DATE ISSUED 6. REQUISITION/PURCHASE NUMBER

CODE7. ISSUED BY 8. ADDRESS OFFER TO (If other than item 7)

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

SOLICITATION

9. Sealed offers in original and copies for furnishings the supplies or services in the Schedule will be received at the place specified in item 8, or if hand carried, in the depository located in until local time

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 B. TELEPHONE (NO COLLECT CALLS)

AREA CODE NUMBER EXTENSION

C. E-MAIL ADDRESS

11. TABLE OF CONTENTS

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

A B C D E F G H

I

J

K

L

M EVALUATION FACTORS FOR AWARD

INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

REPRESENTATIONS, CERTIFICATIONS AND OTHER

STATEMENTS OF OFFERORS

PART IV - REPRESENTATIONS AND INSTRUCTIONS

LIST OF ATTACHMENTS

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

CONTRACT CLAUSESSOLICITATION/CONTRACT FORM

SUPPLIES OR SERVICES AND PRICES/COSTS

DESCRIPTION/SPECS./WORK STATEMENT

PACKAGING AND MARKING

INSPECTION AND ACCEPTANCE

DELIVERIES OR PERFORMANCE

CONTRACT ADMINISTRATION DATA

SPECIAL CONTRACT REQUIREMENTS

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)

12. In compliance with the above, the undersigned agrees, if this offer is accepted within calendar days (60 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 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)

14. ACKNOWLEDGMENT OF AMENDMENTS

(The offeror acknowledges receipt of amendments to the SOLICITATION for offerors and related documents numbered and dated):

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

DATEAMENDMENT NO.AMENDMENT NO. DATE

15A. NAME AND

ADDRESS

OF OFFEROR

CODE FACILITY 16. NAME AND THE TITLE OF PERSON AUTHORIZED TO SIGN

OFFER(Type or print)

15B. TELEPHONE NUMBER

AREA CODE NUMBER EXTENSION

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 21. ACCOUNTING AND APPROPRIATION

22. AUTHORITY FOR USING OTHER THAN FULL OPEN COMPETITION:

10 U.S.C. 2304 (c) ( )41 U.S.C. 3304(a)

24. ADMINISTERED BY (If other than Item 7)

26. NAME OF CONTRACTING OFFICER (Type or print)

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

AUTHORIZED FOR LOCAL REPRODUCTION

Previous edition is unusable

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

(4 copies unless otherwise specified)

25. PAYMENT WILL BE MADE BY

27. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

28. AWARD DATE

CODE

ITEM

STANDARD FORM 33 (REV. 6/2014)

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

SEALED BID (IFB)

NEGOTIATED (RFP)

(Hour) (Date)

PART I - THE SCHEDULE PART II - CONTRACT CLAUSES

1 102

ASPR-BARDA

US DEPT OF HEALTH & HUMAN SERVICES

200 INDEPENDENCE AVE, S.W., Washington DC 20201

75A50121R00018

Yifan Yang yifan.yang@hhs.gov

27 64

202 961 910

8/17/2021

RFP 75A50121R00018

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 August 31, 2021 at 12PM ET. All questions shall be submitted via e-mail to Jill.Johnson@hhs.gov and Yifan.Yang@hhs.gov.

PART I – THE SCHEDULE

SECTION B – SUPPLIES OR SERVICE AND PRICE / COST

B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

Treatment and care for burn injuries is labor intensive and influenced by the unique properties of each case with complicating factors including patient age, pre-existing health conditions, burn wound size, depth and location. 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 likely presented due to a mass casualty incident especially in a geographical area would pose significant limitations on the ability to provide conventional standards of care for victims. To mitigate some of these challenges, BARDA has collaboratively worked with the burn care community to identify areas in the delivery of care and improvements to treatment procedures. Two major areas where enhanced medical countermeasures (MCM) can provide a meaningful difference are in the triage of patients’ initial care and in a definitive burn care setting.

Discussions with the professional burn community and market research data indicate a range of products are available for temporary cover of deep dermal and full thickness burn injuries, which ultimately needs coverage of permanent skin by autografting. However, human skin allograft remains the gold standard for providing temporary wound cover and a reliable product of choice among the burn community. Allografts are widely adopted by burn specialists for initiating the healing of severe burn injuries when an autograft is not medically feasible. During severe medical emergencies prompted by mass casualties, resilient delivery of care is imperative. A large cache and reliable supply of a range of MCMs are a critical part of the preparedness plan. While newer MCMs under development for similar indications might be technologically innovative and are certainly an advanced generational leap, all new products will take time for market integration, build experiential use, and ultimately get widely adopted to supplant legacy MCMs like allograft. This serves as a primary rationale for establishing a robust supply chain of conventional products like human skin allograft for the burn community. For the United States Government (USG) it provides a foundational preparedness on which newer products would, over time, demonstrate value, user experience and ultimately wide adoption with the burn care end-user community.

B.2. PRICES / COSTS

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. The Base Period includes both a Firm-Fixed Price (FFP) Contract Line Item Number (CLIN) to support procurement and capacity building related activities and a Cost-Plus Fixed Fee (CPFF) CLIN to support emergency distribution in the event of a mass casualty. The option periods will include a FFP CLIN and CPFF CLIN to allow the USG to procure additional product units and support emergency distribution of the additional units of products procured beyond what was procured in the base period. The options may be exercised within the base period of the contract, if needed. Below are the anticipated CLINs.

B.2.1. BASE PERIOD

Base Period Fixed Price CLIN

Anticipated Period of

Performance

CLIN Supplies/Services Quantity Unit Price

Total ($)

2021-2026

Base

FFP

Initial Procurement of Skin Allograft, Capacity and Program Infrastructure

12,768,000 cm2

Base Period Cost Reimbursement CLIN

Performance

CLIN Supplies/Services Estimated

Cost Fixed Fee

Cost + Fixed Fee (CPFF)

2021-2026

Base

CPFF

Emergency Distribution

B.2.2. OPTIONS

a. Unless the Government exercises its option pursuant to the option clause referenced in

ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES, this contract consists only of the Base Period specified in the Statement of Work for the price set forth in ARTICLE B.2. of this contract.

b. Pursuant to [FAR Clause 52.217-7/Option for Increased Quantity-Separately Priced Line Item/FAR Clause 52.217-9/Option to Extend] set forth in ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES of this contract, the Government may, by unilateral contract modification, require the Contractor to perform the Option Period(s) specified in the Statement of Work as defined in SECTIONS C and F of this contract. If the Government exercises these options, notice must be given before the expiration date of the contract.

Specific information regarding the time frame for this notice is set forth in Section I.3.1 of this contract. The fixed price/estimated cost of this contract will be increased as set forth in the table below.

c. Upon the delivery and acceptance of the option item described in SECTION C of the contract and identified in the schedule of charges below, the Government shall pay the Contractor the estimated cost and unit price(s) set forth below:

Optional Fixed Price CLINs

Performance

CLIN Supplies/Services Quantity Unit Price

Total ($)

2023-2028

Option Period 1

Additional Procurement Capacity and Program Infrastructure

FFP

2025-2030

Option Period 2

FFP

Additional Procurement Capacity and Program Infrastructure

Optional Cost Reimbursement CLINs

Performance

CLIN Supplies/Services Estimated

Cost Fixed Fee

Cost + Fixed Fee (CPFF)

2023-2028

Option Period 1

CPFF

Additional Emergency Distribution

2025-2030

Option Period 2

CPFF

Additional Emergency Distribution

Total Cost for FFP CLINs 0001, 1001, 2001

Total Cost for CPFF CLINs 0002, 1002, 2002

GRAND TOTAL

*NOTE: In the event of an option exercise, it is anticipated that all CLINs related to an Option Period will be exercised at the same time, i.e. CLINS 1001 & 1002 will be exercised together and CLINS 2001 & 2002 will be exercised together.

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.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 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 $250,000.00;

j) Refreshments and Meal Expenditures;

k) Promotional Items

l) Printing

Section C – DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

C.1. STATEMENT OF OBJECTIVES

BACKGROUND AND PURPOSE

The objective of this Request for Proposal (RFP) is to build a reliable infrastructure for an established medical countermeasure (MCM) within the definitive care paradigm that would provide burn care treatment and aid the recovery of patients even in a mass casualty.

Treatment and care for burn injuries is labor intensive and influenced by the unique properties of each case with complicating factors including patient age, pre-existing health conditions, burn wound size, depth and location. 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 likely presented due to a mass casualty incident especially in a geographical area would pose significant limitations on the ability to provide conventional standards of care for victims. To mitigate some of these challenges BARDA has collaboratively worked with the burn care community to identify areas in the delivery of care and improvements to treatment procedures. Two major areas where enhanced MCMs can provide a meaningful difference are in the triage of patients’ initial care and in a definitive burn care setting.

Discussions with the professional burn community and market research data indicate a range of products are available for temporary cover of deep dermal and full thickness burn injuries, which ultimately needs coverage of permanent skin by autografting. However, human skin allograft remains the gold standard for providing temporary wound cover and a reliable product of choice among the burn community. Allografts are widely adopted by burn specialists for initiating the healing of severe burn injuries when an autograft is not medically feasible. During severe medical emergencies prompted by mass casualties resilient delivery of care is imperative. A large cache and reliable supply of a range of MCMs are critical part of the preparedness plan. While newer MCMs under development for similar indications might be technologically innovative and are certainly an advanced generational leap, all new products will take time for market integration, build experiential use, and ultimately get wide adopted to supplant legacy MCMs like allograft. This serves as a primary rationale for establishing a robust supply chain of conventional products like human skin allograft for the burn community. For the USG it provides a foundational preparedness on which newer products would over time demonstrate value, user experience and ultimately wide adoption with the burn care end-user community.

This Statement of Objective (SOO) focuses on the procurement of human cadaveric skin allograft (hereinafter termed, ‘allograft’). Under this RFP, BARDA plans establish a vendor-managed inventory (VMI) system to support a robust supply chain for allograft, a widely used MCM to provide temporary coverage for burn injuries. Ensuring MCM supply would address product access to end-users, one of the key challenges in the delivery of care. In combination with other efforts, this treatment will enhance the overall capability of burn care specialists to rapidly and effectively temporize and provide cover for burn wound injuries.

SCOPE

The procurement under this RFP has several critical factors that are integral to the overall program rationale described above.

a) Only human cadaveric skin allograft (aka homograft) that meet the attributes described in Section 3 are covered. No other types of products, sources irrespective of their similarity or claimed equivalence in form, function or market data are entertained.

b) Only human skin allograft with a well-established supply-chain by a verifiable, federally recognized Organ Procurement Organization and existing relationships with burn centers will be considered.

c) The USG will procure a specified quantity of skin allograft in the initial base period. Qualified offeror(s) shall have an established inventory management system for storing the procured allograft.

Under VMI offerors are required to routinely rotate and sustainably replenish product inventory as part of their commercial trade, such that the procured product is not lost due to expiry.

d) The USG, at its discretion may expand its preparedness requirement and procure additional skin allograft in future years through the exercise of options. Consequently, the size of the VMI may increase in overall size as illustrated in Table 1, Section 4.

In order to meet the scope outlined above, the Offeror(s) shall address the objectives outlined in the following four sections. Proposals will be evaluated by the USG on their ability to meet these objectives as described below:

Section 1: General Objectives and Product Attributes

Section 2: Procurement Objectives including Initial Procurement

Section 3: Additional Procurements (Option Period 1)

Section 4: Additional Procurements (Option Period 2)

1. General Objectives and Product Attributes

Independently, and not as an agent of the USG, the Offeror 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.

1.1 General Objectives:

The general objectives cover operational and management aspects of this procurement. The following areas are of direct relevance and clear description of these aspects shall be required.

1.1.1 A proposal shall include a dedicated project management team as assigned for this work.

The Offeror shall describe the overall management structure including the four critical areas of production, quality systems, inventory management, and distribution logistics.

Project Management will be the prime contractor’s FTE. The Project Management should not be subcontracted.

1.1.2 The USG anticipates multiple suppliers (tissue banks) of skin allograft to fulfill the planned procurement under this solicitation. Qualified suppliers are encouraged to enter teaming/partnering agreements to accomplish the overall USG procurement objective. If applicable, both qualified Offerors shall identify another Offeror if considering a teaming agreement or opportunity to partner with other accredited Tissue Banks, the Offerors shall address the structure and function of the preferred partnership as defined below:

1.1.2.1 Teaming/Partnering Agreement: Offerors may serve as a co-supplier/co-contractor under one contract award and share the responsibilities for meeting the contract obligations and objectives under this solicitation. The Offeror will describe the value and cost benefit to the USG for such an agreement; and how a teaming agreement would be more efficient for achieving the requirement in this solicitation.

Documentation in support of the teaming agreement would be required from the teaming/partnering entities.

1.1.2.2 Prime/Sub-Contractor: As Prime, one Offeror shall oversee one or more qualified product suppliers and effectively and equitably manage the overall procurement under this solicitation. The Offeror shall specify qualifications and capability to serve as a Prime Contractor and provide documentation to support willingness of other qualified suppliers to participate in a sub-contract role/capacity for purposes of this procurement. Please describe the overall value, efficiency and cost / benefit to all parties including the USG for such an agreement for the planned procurement in this solicitation.

1.2 Product Attributes:

1.2.1 The product shall be classified as a human cadaveric skin allograft, recovered by a federally recognized Organ Procurement Organization (OPO), processed by a Tissue Bank accredited by the American Association of Tissue Banks (AATB) and indicated for the treatment of burn injuries.

1.2.2 The products shall be in routine use for burn care and have no known limitation for use in special populations (pediatrics, immunocompromised, elderly).

1.2.3 The Offeror shall describe the established supply chain for their product. Including, current recovery rate and fluctuations in processing, discard rates, and sales that influence inventory. The description should also cover the inventory management system typically employed that would assure the first-in/first-out tracking for long-term use.

1.2.4 The Offeror shall describe their existing business relationships within the burn care community as well as other vendors and service providers with whom the organizational success is dependent. Such critical relationships include the OPOs, burn centers as well as agreements with key businesses such as liquid nitrogen providers, shipping services, and maintenance service providers, which cover the entire operation.

1.2.5 The Offeror shall provide cost estimates for packing and distribution routinely used to deliver the products. Information should include estimated daily shipping capacity limits during normal business distribution and specifications for any specialized/custom packaging required for product shipment to end-users.

1.2.6 Human Cadaveric Skin Allograft Desirable Attributes:

Recovered from a Federally recognized OPO

Processed in a AATB Accredited Tissue Bank

Indicated for Burn Wounds

Split-thickness Homograft thickness between .30 to .45 mm

Cryopreserved at -40 to -80 Degrees Celsius

<2 minutes Rapid Thaw Preparation

Non-meshed

Average Tissue Unit Size of 464 sq cm

Medically Cleared for Use

Shelf life >5 years

2. Procurement Objectives

The USG intends to procure allograft and its access maintained under a VMI to ensure its availability on-demand for burn centers nationally to treat deep partial and/or full-thickness skin burn injuries. As part of an immediate and initial procurement under this solicitation, the USG is seeking product(s) to build a multi-site VMI so as to provide allograft availability to treat approximately 2,000 of individuals with >30%TBSA injuries. We anticipate the approximate procurement at multiple sites would total up to 12,768,000 cm2 of allograft treatment. The USG reserves the right and sole discretion to determine the final amount of product procurement based on multiple factors including but not limited to availability of funds.

Table 1: Contract Procurement

POP CLINS Deliverable VMI (Minimum)

Average Tissue Unit Size of 464 sq cm (approximate)

BASE

Initial Procurement of skin allograft, Production and Distribution Timeline, VMI Plan

12,768,000 cm2 (approximate)

0002 Emergency Distribution N/A

OPTION PERIOD 1

1001 Additional Procurement 12,768,000 cm2 (approximate)

1002 Emergency Distribution N/A

OPTION PERIOD 2

2001 Additional Procurement/ 12,768,000 cm2 (approximate)

2002 Emergency Distribution n/a

Offerors responding to this solicitation must meet the following criteria:

2.1 Objectives outlined under General Objectives and Product Attributes, specifically Offerors must be an AATB accredited Tissue Bank with the described infrastructure and capability.

2.2 Shall have a sufficient volume in their supply pipeline and routine distribution of product to maintain a VMI capability for the specified requirement. To enable a thorough evaluation of the Offeror’s capability and manage procurement, a detailed proposal shall at the minimum address the following areas:

2.2.1 Describe current typical product inventory levels that meet the criteria in this solicitation.

Provide potential for product surplus inventory and annual product turnover for product(s) SKU# that are closest to the specifications in Table 1.

2.2.2 A production plan and timeline that describes the facilities, resources and capabilities

(e.g. inventory management system, tracking and allocation software) necessary to process and store product under normal market conditions.

2.2.3 To describe and illustrate the potential capability for a surge capacity and tissue processing that could be activated during public health emergencies, the Offeror shall provide realistic plans and requirements. The plan should clearly outline the capabilities that are feasible and that need to be built.

2.2.4 A Current Good Tissue Practice (cGTP) compliant storage and stability plan that describes the methodology for long term storage, shelf live extension plans (if any), inventory management and processes that minimize or eliminate loss due to expiry. The product is expected to be stored at the Offeror’s site or with a third party (for example, under a vendor managed /distributor-managed arrangement). In either scenario, the Offeror shall be responsible to ensure compliance of procured products under storage.

2.3 Shall explicitly state their maximum annual capacity to procure, process, and store skin allograft inventory. In addition to support future procurements, the offeror shall provide a justifiable projection for additional capacity. Offerors shall not overstate their maximum capacity to recover, process, store or deliver towards the government’s projected procurement outlined in this solicitation. This is critical to ensure Offerors provide a justifiable accounting strategy of their typical product flow to accommodate substantial inventory rotation at various levels of planned procurement.

3. Base Period of Performance – Initial Procurement (BASE POP CLINs 0001 and 0002)

3.1 CLIN-0001 (Initial Procurement of Human Cadaveric Skin Allograft): Although procurement of approximately 12,768,000 cm2 of skin allograft may be supported by this CLIN, the Business Proposal for initial procurement shall be aligned with the Offeror’s realistic capacity to deliver product in addition to the corresponding price per skin allograft unit. Offerors are encouraged to provide volume discounts for subsequent procurement under CLINs 0001, 0003, 0005.

Specifically, the proposed unit price in CLIN 0005 should be lower than unit price in CLIN 0003, which in turn is lower than CLIN 0001

3.2 CLIN-0002 (Emergency Distribution of Skin Allograft): This CLIN may be utilized to support the packaging and distribution of procured quantities under CLIN 0001 (up to 12,768,000 cm2) of skin allograft in a declared emergency or on demand by a CO or an authorized representative. Although there exists a degree of uncertainty as to the quantity, location, and incident itself, it is expected that the costs outlined within the Business Proposal shall be consistent with a distribution plan which assumes a worst case scenario for factoring the farthest distance and entire available inventory being deployed as detailed in the Technical Proposal.

4. Option Period 1 - Additional Procurements (Option Period 1 CLINs 1001 and 1002)

4.1 To maintain preparedness, the USG shall at its discretion, execute optional additional procurements to maintain or increase the inventory levels of allograft. The additional procurement may be similar to the initial procurement approximately equivalent to treating 2000 additional patients with >30% TBSA injuries. The additional procurements are expected to continue to be stored and managed at the same locations and will approximately be equivalent to 12,768,000 cm2 of additional allograft treatment. The Offeror shall provide a proposal for this potential additional procurement in addition to maintaining the inventory of product already procured (see Table 1, Section 4). The USG has the sole discretion to determine the amount of product to be procured under this Option based on multiple factors including availability of funds.

4.2 CLIN-1001 (Additional Procurement of Human Cadaveric Skin Allograft): This CLIN may be utilized to support additional procurement phases for approximately 12,768,000 cm2 of skin allograft. The offeror shall provide pricing per CLIN that address the specifics of these procurement phases with respect to volume and vendor managed inventory. Within the Business Proposal, costs for these CLINs shall rely upon “not to exceed” capacity or government requirement. Offerors are encouraged to provide volume discounts for CLINs 0001, 0003, 0005. Specifically, the proposed unit price in CLIN 0005 should be lower than unit price in CLIN 0003, which in turn is lower than CLIN 0001.

4.3 CLIN-1002 (Emergency Distribution of Skin Allograft): This CLIN may be utilized to support the packaging and distribution of procured quantities under CLIN 0003 (up to 12,768,000 cm2) of skin allograft in a declared emergency or on demand by a CO or an authorized representative. Although there exists a degree of uncertainty as to the quantity, location, and incident itself, it is expected that the costs outlined within the Business Proposal shall be consistent with a distribution plan which assumes a worst case scenario for factoring the

5. Option Period 2 - Additional Procurements (Option Period 2 CLINs 2001 and 2002)

5.1 To maintain preparedness, the USG shall at its discretion, execute optional additional procurements to maintain or increase the inventory levels of allograft. The additional procurement may be similar to the initial procurement approximately equivalent to treating 2000 additional patients with >30% TBSA injuries. The additional procurements are expected to continue to be stored and managed at the same locations and will approximately be equivalent to 12,768,000 cm2 of additional allograft treatment. The Offeror shall provide a proposal for this potential additional procurement in addition to maintaining the inventory of product already procured (see Table 1, Section 4). The USG has the sole discretion to determine the amount of product to be procured under this Option based on multiple factors including availability of funds.

5.2 CLIN-2001 (Additional Procurement of Human Cadaveric Skin Allograft): This CLIN may be utilized to support additional procurement phases for approximately 12,768,000 cm2 of skin allograft. The offeror shall provide pricing per CLIN that address the specifics of these procurement phases with respect to volume and vendor managed inventory. Within the Business Proposal, costs for these CLINs shall rely upon “not to exceed” capacity or government requirement. Offerors are encouraged to provide volume discounts for CLINs 0001, 0003, 0005. Specifically, the proposed unit price in CLIN 0005 should be lower than unit price in CLIN 0003, which in turn is lower than CLIN 0001.

5.3 CLIN-2002 (Emergency Distribution of Skin Allograft): This CLIN may be utilized to support the packaging and distribution of procured quantities under CLIN 0005 (up to 12,768,000 cm2) of skin allograft in a declared emergency or on demand by a CO or an authorized representative. Although there exists a degree of uncertainty as to the quantity, location, and incident itself, it is expected that the costs outlined within the Business Proposal shall be consistent with a distribution plan which assumes a worst case scenario for factoring the

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 Offeror.

C.3. MEETINGS / SITE VISITS

The Contractor and BARDA/CMA 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 meetings and/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 contractual aspects of the program. The Contractor shall provide data, reports, and presentations to 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. Bi-weekly or monthly status update meetings/teleconferences will be held. The schedule for these meetings will be established by the CO and COR.

Periodic site visits shall occur on an ad hoc basis (anticipate at least twice a year).

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 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(s). 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 subcontractor(s).

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 CO, delivery of reports to be furnished to the Government under this contract (including invoices) shall be delivered to the CO and COR electronically along with a concurrent email to the CO and COR (as defined in Section F.3.1 Submission of Contract Deliverables summarizing the electronic delivery.

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 take place at:

Biomedical Advanced Research and Development Authority Office of the Assistant Secretary for Preparedness and Response 200 C Street, S.W.

Washington, D.C. 20024

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

FAR 52.246-2, Inspection of Supplies – Fixed-price (August 1996)

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

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

SECTION F – DELIVERIES OR PERFORMANCE

F.1. PERIOD OF PERFORMANCE

The base period of performance of this contract is anticipated for sixty (60) months from the date of award. The period of performance may be extended up to 60 months 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), Jill.Johnson@hhs.gov. No hard copies will be accepted.

For electronic delivery, the Contractor shall upload documents to the appropriate folder on https://eroom.bardatools.hhs.gov/eRoom (“eRoom”) which is the designated Government file sharing system. The Government shall provide two contractor representatives authorized log in access to the file share program. Each representative must complete a mandatory training provided by the Government prior to gaining user access. A notification email should be sent to the CO and COR upon electronic delivery of any documents.

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, and approval by the CO/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). Contractors must 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.

SECTION II Part G: CONTRACTING OFFICER APPROVALS – This section shall include a table indicating each Contracting Officer Approval (COA) request, its current status (e.g. date submitted, date approved, date returned), amount requested, and the vendor for which the COA authorizes subcontracted work to be performed.

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

A Monthly Progress Report will not be required in the same month Annual Progress Reports or a Final Report 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). Contractors must 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.

SECTION II Part G: CONTRACTING OFFICER APPROVALS – This section shall include a table indicating each Contracting Officer Approval (COA) request, its current status (e.g. date submitted, date approved, date returned), amount requested, and the vendor for which the COA authorizes subcontracted work to be performed.

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. Other Requirements/Deliverables

a) Integrated Master Project Plan

The Contractor shall provide an Integrated Master Project Plan (including tabular and Gantt forms) to the COR 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 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.

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.

II. Work Breakdown Structure The WBS shall be discernable and consistent. The COR may require the 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.

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.

b) 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.

c) 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.

d) Security Plan

See attachments 15 and 16 for security requirements and a template for the Security Plan.

e) Quality Management System Plan

The Contractor shall submit to the COR a Quality Management System Plan for approval no later than 60 days from the date of award.

f) Production and Inventory Management Plan

The Contractor shall submit to the COR a comprehensive production and inventory management plan for review and approval no later than 60 days from the date of award.

F.4. DELIVERABLE SCHEDULE

Item No.

Description Addresses Deliverable Schedule

1 Bi-Weekly Meetings and Meeting Minutes

CO: (1) electronic copy

COR: (1) electronic copy

Meeting minutes are due no later than five business days following each meeting.

2 Monthly Progress Report

CO: (1) electronic copy

COR: (1) electronic copy

Reports are due on or before the 15th of each month following the end of each reporting period.

3 Annual Progress Report

CO: (1) electronic copy

COR: (1) electronic copy

Reports are due on or before the 30th calendar day following the end of each reporting period.

4 Draft Final Progress Report

CO: (1) electronic copy

COR: (1) electronic copy

Report is due 45 Calendar days prior to the expiration date of the…