32a. QUANTITY IN COLUMN 21 HAS BEEN

☐ RECEIVED ☐ INSPECTED ☐ ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED: _________________________

NAME OF OFFEROR OR CONTRACTOR

AVITA MEDICAL AMERICAS, LLC 1476585

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 both resource and labor intensive. The national capacity is typically limited and presents a significant limitation to when a sudden surge capacity is required in a burn mass casualty incident (BMCI). A BMCI in a geographic area could overwhelm a regional existing capacity and present substantial resource constraints. To mitigate this challenge, BARDA has collaboratively worked with the burn care community to identify areas of improvement in the delivery of this care. This collaboration has identified numerous area which BARDA has systematically addressed over the years. 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.

Autografting is the current standard of care for long term treatment and recovery of deep partial and full thickness burn injuries. This involves removing healthy skin from an uninjured area of the patient’s body and affixing it on top of the burn wound. 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. Discussions with the professional burn community and market research data indicates that products that reduce the amounts of autograft needed to provide wound closure (autograft-sparing) can provide an advantage for rapid and effective care of severe burn injuries. Such products also have the potential to reduce the morbidity of the donor sites. Such products should be compatible with current procedures to allow easy integration so they could be also used during a mass casualty scenario involving significantly high numbers of burn patients. Additionally, such products that have indications for full thickness skin defects due to traumatic injury would be advantageous to address additional injuries resulting from an MCI. This Statement of Objective (SOO) focuses on products which could contribute to autograft-sparing in burn and trauma patients and potentially accelerate the healing process while leading to better outcomes.

Based on this background, the objective of this RFP is to support procurement of an approved autograft sparing device. The technology must be capable of treating both full thickness thermal burn wounds as well as full thickness skin defects resulting from trauma. Procurement strategies would include use of an Access-Maintenance Vendor Managed Inventory (AM-VMI) contract covering the period of performance. Via this Access-Maintenance VMI, the Offeror will maintain a cache of product determined by the shelf life and sales volume. This cache will be maintained by the Offeror monthly to ensure all product is within expiry and report total inventory numbers to BARDA. In return, BARDA will pay for this monthly maintenance cost and the right to access/procure this VMI cache in the event of a national emergency.

The negotiated terms include the price per unit as well as the size of the product inventory. This system allows for maximum national preparedness while limiting waste of unused product by only procuring the product if it is needed to respond to a mass casualty incident.

B.1.1. Definitions

Access-Maintenance Vendor Managed Inventory (AM-VMI) – The Contractor and U.S. Government (USG) agree the USG shall pay a fee for the contractor to hold, and maintain in reserve, a negotiated level of commercially useable product for its intended purpose in delivery of care; and the entire product inventory shall be available for purchase by USG. The Contractor and the USG also agree to a pre-negotiated price for procurement on demand of the products in the inventory, to mutual terms for periodically expanding the size of the inventory, and for the contractor to deploy the procured product via their commercial processes and infrastructure or in collaboration with the Strategic National Stockpile (SNS).

Commercial Product – As defined in FAR 2.101.

Food and Drug Administration (FDA) Approved - The FDA approval of a medical product (e.g., drug, device or biologic) means the product’s safety and effectiveness have been reviewed by the FDA and the product’s known and potential benefits outweigh the known and potential risks. If the FDA grants an approval, it means the agency has determined the product is safe and effective for its intended use.

Government Furnished Property (GFP) - All property owned or leased by the Government. Government property includes both Government-furnished property and contractor-acquired property. Government property includes material, equipment, special tooling, special test equipment, and real property.

Government property does not include intellectual property and software. The Government shall not own any property under this contract.

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 of up to ten (10) years.

The Base Period consists of five Firm Fixed Price CLINs to support procurement, maintenance, and emergency deployment of autograft sparing devices. This requirement has no proposed or required options at this time.

B.2.1. BASE PERIOD

B.2.2. PBS Contract Authority: 42 USC 247d-6b(c) and (g), the Project BioShield Act of 2004.

B.2.3. Multi-Year Contract: Multi-year Project BioShield (PBS) contract means a contract for the purchase of supplies or services for more than one, but not more than ten, program years. A multi-year contract may provide that performance under the contract during the option periods and subsequent years of the contract is contingent upon the appropriation of funds, and (if it does so provide) may provide for a cancellation payment to be made to the contractor if appropriations are not made. The key distinguishing difference between multi-year contracts and multiple year contracts is that multi-year contracts, defined in the statutes cited at 17.101, buy more than one year’s requirement (of a product or service) without establishing and having to exercise an option for each program year after the first.

B.2.4. Type of Contract: The Contracting Officer has determined this to be a Firm-Fixed Priced (FFP) Contract.

B.3. ADVANCE UNDERSTANDINGS

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

B.3.1. The Contracting Officer shall designate in writing the specific delivery date, location, and any additional information required for delivery of up to a maximum of [***] units of Autograft Sparing Devices. Avita Medical Americas, LLC shall provide the specific delivery date, shipping company information, driver information (may or may not be required), quantity and inventory information. Additional requirements may be required by the receiving location, if so, this information shall be provided in writing by the Contracting Officer or designated representative.

B.3.2. The Contractor shall provide a Quality Agreement to BARDA within sixty-days of the awarded contract for review and approval. This Quality Agreement shall outline the responsibilities of both the Contractor and BARDA for product shipping, receiving, and storage. These documents shall be bilaterally signed once approved by both parties. This Quality Agreement will be a deliverable on the contract and will not supersede the terms and conditions of the overarching contract.

B.3.3. The Contractor shall notify the Government of changes impacting the product availability and/or their delivery (such as but not restricted to manufacturing processes, component systems, including those may or may not be reported to the FDA). The Contractor shall notify the Government of changes to the product delivery system. The Government, in collaboration with the Contractor, shall have the right to adjust the total products available for procurement within the Access Management – Vendor Managed Inventory (AM-VMI) or establish a new CLIN for additional procurements based upon technological or manufacturing advancements and the Governments requirements.

B.3.4. In addition to the planned potential procurement of the total established number of units under the contract ([***] units), should there be a need to procure additional units, BARDA would like to have the right of first refusal for any additional units available and/or the production planned by Avita Medical Americas, LLC. The delivery schedule and price per unit for these units would match the best commercial price available at the time of need.

Rights In Data

Shall be in accordance with 52.227-14 Rights in Data-General.

Travel

No travel is anticipated for this award at this time.

Person-in-Plant

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

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

Security

A security plan will be submitted for approval within 90 days of award. See Section J.

Subcontracts

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

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

Note: Consulting services are treated as subcontracts and subject to the ‘consent to subcontract’ provisions set forth in this Section. In accordance with Health and Human Services Acquisition Regulation 352.231-70 Salary Rate Limitation - (a) The Contractor shall not use contract funds to pay the direct salary of an individual at a rate in excess of the Federal Executive Schedule Level II in effect on the date the funding was obligated.

(b) For purposes of the salary rate limitation, the terms “direct salary,” “salary,” and “institutional base salary,” have the same meaning and are collectively referred to as “direct salary,” in this clause. An individual's direct salary is the annual compensation that the Contractor pays for an individual's direct effort (costs) under the contract. Direct salary excludes any income that an individual may be permitted to earn outside of duties to the Contractor. Direct salary also excludes fringe benefits, overhead, and general and administrative expenses (also referred to as indirect costs or facilities and administrative costs). The salary rate limitation does not restrict the salary that an organization may pay an individual working under a Department of Health and Human Services contract or order; it merely limits the portion of that salary that may be paid with contract funds. This applies to subcontractors and consultants.

Overtime Compensation

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

Invoice Submission during end of Fiscal Year

The government will not accept invoices for processing from September 15th through first week in October for processing because of end of year fiscal requirements. Any invoices received from September 15th through the first week in October, will be processed when financial systems are available.

B.4 ORGANIZATIONAL CONFLICT OF INTEREST

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.

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:

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):

SECTION C – DESCRIPTION / SPECIFICATIONS / WORK STATEMENT

C.1. STATEMENT OF OBJECTIVES

BACKGROUND and PURPOSE

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 anticipated high number of injured in 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 to improve the delivery of care and treatment procedures. Two major areas where enhanced medical countermeasures (MCM) can provide a meaningful difference are in the triage of initial care and in a definitive burn care setting.

A large burn mass casualty incident could quickly overwhelm the US healthcare infrastructure. Severe burn injuries (especially, >10% Total Body Surface Area (TBSA) typically require highly specialized care for effective delivery of resource-intensive therapies including surgeries. Nationally, this capability is critically limited at multiple levels and would challenge timely access and treatment of those injured even in a relatively small incident. This makes it imperative to leverage technology that reduces the amount of donor skin required for full thickness and large deep partial thickness burns. Reducing the required amount of donor skin for delivery of definitive care has the potential to greatly improve the patient’s quality of life while reducing hospital length of stay and the need for reconstructive surgery.

OBJECTIVE

For building national burn care preparedness under the conditions described above, BARDA intends to procure FDA approved products which can reduce the amount of autograft required to provide definitive coverage for any traumatic injuries or for full and deep partial thickness burn injuries. Such autograft sparing technologies significantly reduce the amount of donor skin required to treat full thickness burns and other full thickness skin defects in trauma to reduce patient morbidity and mortality.

To build national preparedness and address the unmet needs identified in both burn and trauma care, products shall meet both the capabilities:

As an FDA approved product, it is expected the product use case settings would include both burn and trauma centers. Information on the integration of the products in these routine healthcare settings would be important towards the indicated purpose to build national preparedness and availability for use and trained physicians.

Under this RFP, BARDA plans to establish an access-maintenance vendor-managed inventory (VMI) system. In this system, the Offeror is required to maintain as part of the normal (commercial) operations a pre-specified (negotiated) inventory stock of devices which are accessible on demand. In the event of a mass casualty incident and upon notification by the U.S. Government (USG), the stock shall be available in its entirety for immediate procurement and deployment to identified burn and trauma centers within 24 hours.

SCOPE

This Access-Maintenance Vendor Managed Inventory (AM-VMI) procurement of an FDA-approved autograft-sparing product. Critical attributes of the device shall include the capability to reduce the amount of donor skin required to treat full thickness wounds from burns and trauma in children and adults. The following areas of work are considered within the overall scope:

The vendor would maintain a cache of ready for use product units as part of the commercial inventory management. The product units are part of the vendor’s commercial operation inventory management. The inventory is actively managed under first in- first out principle to ensure the newly manufactured product unit remains in the inventory. If a mass casualty occurs or other emergency at the USG discretion, the vendor may be notified of USG’s intent to procure a part or the entire cache of the devices in the inventory. The size of the initial cache would be subject to negotiations up to a maximum of [***]

unit devices. At any point during the duration of the contract, the USG may notify the Offeror of an intent to procure up to [***] units from the Access-Maintenance VMI. At that time, the Offeror shall provide all necessary documentation for quality assurance and acceptance of the product by the USG. In the case of a commercial product, only what is consistent with customary commercial practice under FAR 12.301(a) will be required (e.g., Certificate of Conformance).

The Offeror shall include commercial sales data to demonstrate the capability to manufacture and store a surplus inventory of a minimum of [***] unit devices. The Offeror shall also provide data supporting their manufacturing capacity.

The Offeror shall maintain a cache of devices available for emergency deployment purposes. The stock in this inventory shall be rotated as part of routine sales using the principle of “First Expiry, First Out”. The final number of units in the inventory would be subject to finalization as part of the negotiation but should address capability to maintain a minimum of [***]devices up to a total ramp up of [***] devices. Ideally, with increased sales and growth in the market share over time, USG anticipates the Offeror would be able to increase the size of the cache by an additional [***] devices (to a total of [***] devices maintained under VMI). Each unit shall have at least 3 months of shelf-life as part of the access-maintenance VMI.

Under this CLIN, the Offeror shall provide information on the availability of resources for inventory maintenance / management activities. The Offeror shall include data demonstrating the approved shelf-life of the device, tracking and shuffling inventory and the ability to ensure a minimum shelf-life for all products in the access-maintenance VMI. The Offeror shall specify how the process is organized and managed with Standard Operating Procedures (SOPs).

If the USG procures up to [***]units from the Access-Maintenance VMI, the offeror will be required to prepare the specified number of units for emergency deployment within 24 hours of notification.

Towards the original goals for national preparedness, USG may consider the need to increase in the size of the cache to be held as part of inventory available for procurement. An anticipated increase in the size of the cache would be up to [***] devices (or as negotiated) for access and maintenance and available for procurement to be delivered within an agreed upon timeframe. If the commercial market cannot sustain maintenance of the larger cache, the Offeror shall provide the shortest ramp up plan to manufacture and deliver the additional devices and timeframe required. At any point during the duration of the contract, the USG may notify the Offeror of an intent to procure from these additional units. At that time, the Offeror shall provide all necessary documentation for quality assurance and acceptance of the product by the

USG. In the case of a commercial product, only what is consistent with customary commercial practice under FAR 12.301(a) will be required (e.g., Certificate of Conformance).

Upon purchase of additional devices in CLIN 004 above, the offeror will be required to prepare a specified number of units for emergency deployment within 24 hours of notification.

The Offeror is directed towards details provided in the section on Reporting Requirements. The work here is intended to be performed in the Base period. Hence, all SOW activities generated for the duration of the contract shall have a Project Management and Risk Mitigation section covering objectives in this CLIN.

C.2. REPORTING REQUIREMENTS

See Section F for specific reporting requirements.

Performance of the contract will be monitored by the Contracting Officer (CO)/Contracting Officer’s Representative (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 CO/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. 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.

Within thirty (30) calendar days of an FDA audit of Contractor or subcontractor facilities, related to the Contracted Products, 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. PACKAGING OF PRODUCT

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

D.2. MARKING

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

D.3. DISTRIBUTION AND DEPLOYMENT/SHIPPING SERVICES

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

All Products shall be labeled and packaged in accordance with GCP (Good Clinical Practices) and/or cGMP (Current Good Manufacturing Practices) as appropriate. Products shall be packed to ensure compliance with known product stability requirements that maintain satisfactory product temperatures during transit and arrival at destination. Products shall be packed to ensure maintenance of FDA recommended temperature during transit and safe arrival at destination

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

D.3.1. SPECIFIC SHIPPING SERVICES

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

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

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

D.3.2. PACKAGE PRODUCT FOR PICKUP BY THE USG

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

D.3.3. AVITA MEDICAL PRODUCT SHIPPING

D3.3.1. Formal agreement with the following shipping carriers for domestic shipments:

D.3.3.2. Typical Delivery Timeframes:

D.3.3.3. Risk Mitigation and Redundancy Measures:

Assuming air carriers are operating normally, then the most expedient way to deploy the devices will be to use the common carriers with whom we have contracts as delineated previously. If air travel is not operating normally, then ground transportation would be the alternative. Timeframes for delivery, assuming cross-country from California via air would be 24 hours or less, and ground transportation will depend on routes taken and delivery location, typically 5 business days.

SECTION E – INSPECTION AND ACCEPTANCE

E.1. INSPECTION AND ACCEPTANCE

Inspection and acceptance of the product, services, and documentation (Certificate of Conformance) shall be shared via email with Contracting Officer or the designated Contracting Officer’s Representative prior to product acceptance. Acceptance of a commercial product will be consistent with customary commercial practice under FAR 12.301(a).

Acceptance may be presumed unless otherwise indicated in writing by the Contracting Officer or the designated COR within 30-days of receipt.

E.2. FEDERAL ACQUISITION REGULATION CLAUSES INCORPORATED BY REFERENCE

This contract incorporates the following 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) (CLINs 001 – 005)

FAR 52.246-4 Inspection of Services-Fixed-Price (Aug 1996) (CLIN 002)

FAR 52.246-16, Responsibility for Supplies (April 1984) (CLINs 001 – 005)

E.3. INSPECTION, ACCEPTANCE AND CONTRACT MONITORING

Inspection and acceptance of the product, services, and documentation called for herein shall be accomplished by the Contracting Officer or designated COR consistent with customary commercial practice under FAR 12.301(a).

At the discretion of the Government and independent of activities conducted by the Contractor, with 48-hours’ notice to the Contractor, the Government reserves the right to conduct site visits and inspections related to this Contract on an as needed basis during normal business hours, including collection of product samples and intermediates held at the location of the Contractor, or its subcontractor. The Contractor shall coordinate these visits and shall have the opportunity to accompany the Government on any such visits. Under time-sensitive or critical situations, the Government reserves the right to suspend the 48-hour notice to the Contractor. The areas included under the site visit could include, but are not limited to: security, regulatory and quality systems, manufacturing processes and cGMP/GLP/GCP compliance related to activities funded under this Contract.

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

SECTION F – DELIVERIES OR PERFORMANCE

F.1. PERIOD OF PERFORMANCE

The base period of performance of this contract is anticipated for a maximum of [***]-months from the date of award.

F.2. DELIVERIES

Successful performance of the final contract shall be deemed to occur upon performance of the work described in SECTION C of this RFP and upon delivery and acceptance of the items described in SECTION F.3 by the Contracting Officer or designated COR.

F.2.1. Place and method of delivery for Product purchased will be determined at the time of procurement or as determined necessary to respond to an emergency scenario. Refer to SECTIONS F.2.2, F.2.3, and F.2.4. for place and method of delivery requirements for those Items.

F.2.2. When distribution and shipping of product is ordered, delivery of the product and other deliverables shall be in accordance with FAR 52.247-34 entitled F.O.B. DESTINATION.

F.2.3. When product preparation for pick-up by the USG is ordered, delivery of drug product and other deliverables shall be in accordance with FAR 52.247-30 entitled F.O.B. ORIGIN, CONTRACTOR’s FACILITY.

F.2.4. Place of Delivery: The Product shall be delivered as requested by the CO or authorized representative prior to time of delivery.

F.2.5. Manufacturers product stability requirements shall be maintained during shipping. If the Product is determined to be out of compliance, (if determined) will not be accepted or off-loaded from the Contractor’s own or subcontracted conveyance but will be immediately returned to Contractor by the

same transport used for delivery, at the Contractor’s cost. The Contractor shall be responsible for replacing the product that is not with compliance, at no additional cost to the Government.

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), R. Anthony Hall at [***] and the Contracting Officer Representative (COR), Janelle Hurwitz at [***]. No hard copies will be accepted.

F.3.1. Reporting Requirements

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:

This report shall include a table of the available products within the Access-Maintenance VMI during each 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 Inventory 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.

The inventory report shall contain the following information:

Contracting Officer’s 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 Inventory Report will not be required in the same month Annual Inventory Report is due.

This report shall include a summation of the product inventory rotations during the 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 Inventory 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.

The inventory report shall contain the following information:

Contracting Officer’s 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.

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.

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.

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.

See attachment 8 for security requirements and a template for the Security 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.

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

F.4. DELIVERABLE SCHEDULE

SECTION G – CONTRACT ADMINISTRATION

AUTHORITIES OF GOVERNMENT PERSONNEL

Notwithstanding the Contractor's responsibility for total management during the period of performance, the administration of this contract will require maximum coordination between the Government and the Contractor.

The following individuals will be the Government's points of contact during the performance of this contract:

G.1. CONTRACTING OFFICER (CO)

R. Anthony Hall (Tony)

Contracting Officer – CBRN Contracts

Contract Management and Acquisition (CMA)

Center for the Biomedical Advanced Research & Development Authority (BARDA)

Administration for Strategic Preparedness and Response (ASPR)

U.S. Department of Health and Human Services (DHHS)

Email: [***]

All communications pertaining to contractual and/or administrative matters under this contract shall be sent to the Contracting Officer.

The Contracting Officer is the only individual who can legally commit and bind the Government to the expenditure of public funds. No person other than the Contracting Officer can make any changes to the terms, conditions, general provisions or other stipulations of this contract. Any other commitment, either explicit or implied, is invalid.

The CO is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of objectives; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; (5) obligate or de-obligate funds into the contract; (6) sign written licensing agreements; or (7) otherwise change any terms and conditions of this contract.

No information, other than that which may be contained in an authorized modification to this contract duly issued by the Contracting Officer, which may be received from any person employed by the United States Government, or otherwise, shall be considered grounds for deviation from any stipulation of this contract. NOTE: An unauthorized commitment is an agreement that is not binding solely because the Government representative who made it lacked the authority to enter into that agreement on behalf of the Government. An unauthorized commitment (UC) usually results in the receipt of goods or services on behalf of the Government by someone with apparent authority, but that lacks the authority to obligate the Government; it can be intentional or unintentional. Only a warranted contracting officer has authority to obligate government funds and contractually bind the government for supplies and services within their warrant authority.

G.2. CONTRACTING OFFICER’S REPRESENTATIVE (COR)

The Government's Contracting Officer’s Representative (COR) is:

Janelle Hurwitz MS, MBA, PMP

Biologist/Project Officer COR III, Burn and Blast Medical Countermeasures

Division of Chemical, Biological, Radiological and Nuclear Countermeasures

Center for the Biomedical Advanced Research and Development Authority

Administration for Strategic Preparedness and Response

U.S. Department of Health and Human Services

[***]

As delegated by the CO, the COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) assisting the CO in interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

The COR is not authorized to make any commitments or changes that will affect price, quality, quantity, delivery, or any other term or condition of the contract.

Additionally, the COR is not empowered to, nor does he/she have the authority to, perform any of the following duties since, in accordance with FAR, they are reserved only for a Contracting Officer:

G.3. CONTRACTOR’S POINTS OF CONTACT

The Contractor shall provide primary and secondary points of contact that will be available 24 hours per day, 7 days per week, to be notified in case of a public health emergency.

G.4. KEY PERSONNEL, HHSAR 352.237-75 (December 2015)

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to the Contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract (including, when applicable, Human Subjects Testing requirements). If the employee of the Contractor is terminated for cause or separates from the Contractor voluntarily with less than thirty (30) days’ notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties. Key Personnel shall be limited to the minimal amount of personnel for successful completion of the contract as reasonably determined by Contractor.

The following individual(s) is/are considered to be essential to the work being performed hereunder:

G.5. INVOICE SUBMISSION

Electronic Submission of Payment Requests

(1) “Payment request” means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), “Content of Invoices” and the applicable Payment clause included in this contract.

(End of Clause)

The Contractor agrees to include (as a minimum) the following information on each invoice:

The invoice shall be signed by a person authorized to bind the Contractor.

The Contractor shall not submit an invoice prior to delivery of goods or services.

The Contractor shall provide all invoices to the Contracting Officer and Contracting Officer’s Representative for review and approval prior to submission to IPP.

G.6. GOVERNMENT PROPERTY

Not applicable at this time because the Government does not anticipate purchasing property for this performance of this acquisition apart from the deliverables. The USG shall pay a fee for the contractor to hold, and maintain in reserve, a negotiated level of commercially useable products for its intended purpose in delivery of care; and the entire reserved product inventory shall be made available to the USG under the Access-Maintenance Vendor Managed Inventory. Once products are shipped to a designated area, they will not be returned to the contractor’s inventory or to the USG. If any Government Property shall be produced under this award, it shall be in accordance with 52.245-1 Government Property.

G.7. CONTRACT COMMUNICATIONS/CORRESPONDENCE

The Contractor shall identify all correspondence, reports, and other data pertinent to this contract by imprinting thereon the contract number on all correspondences.

G.8. POST AWARD EVALUATION OF OFFEROR PERFORMANCE

In accordance with FAR Subpart 42.11 - Contractor Performance Information.

42.1100 Scope of subpart. This subpart provides policies and establishes responsibilities for recording and maintaining contractor performance information.

42.1101 General.

(i) Favorable consideration of a mentor with an SBA-approved mentor-protégé agreement (see 13 CFR 125.9) that subcontracts to its protégé, and

(ii) That protégé is a covered territory business or that protégé's principal office is located in the Commonwealth of Puerto Rico (see 15 U.S.C. 632(ff));

SECTION H – SPECIAL CONTRACT REQUIREMENTS

H.1. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE

Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in BARDA funded programs should report such matters to the HHS Inspector General's Office in writing or on the Inspector General's Hotline. The toll free number is 1- 800-HHS-TIPS (1-800- 447-8477). All telephone calls will be handled confidentially. The e-mail address is Htips@os.dhhs.gov and the mailing address is:

Office of Inspector General

Department of Health and Human Services TIPS HOTLINE

P.O. Box 23489 Washington, D.C. 20026

H.2. PROHIBITION ON CONTRACTOR INVOLVEMENT WITH TERRORIST ACTIVITIES

The Contractor acknowledges that U.S. Executive Orders and Laws, including but not limited to 13224 and P.L. 107-56, prohibit transactions with, and the provision of resources and support to, individuals and organizations associated with terrorism. It is the legal responsibility of the Contractor to ensure compliance with these Executive Orders and Laws. This clause must be included in all subcontracts issued under this contract.

H.3. IDENTIFICATION AND DISPOSITION OF DATA

The Contractor will be required to provide certain data generated under this contract to the Department of Health and Human Services (DHHS). DHHS reserves the right to review any other data determined by DHHS to be relevant to this contract. The Contractor shall keep copies of all data required by the Food and Drug Administration (FDA) relevant to this contract for the time specified by the FDA.

H.4. EXPORT CONTROL NOTIFICATION

Contractors are responsible for ensuring compliance with all export control laws and regulations that may be applicable to the export of and foreign access to their proposed technologies. Contractors may consult with the Department of State with any questions regarding the International Traffic in Arms Regulation (ITAR) (22 CRF Parts 120-130) and /or the Department of Commerce regarding the Export Administration Regulations (15 CRF Parts 730-774).

H.5. CONFLICT OF INTEREST

The Contractor represents and warrants that, to the best of the Contractor's knowledge and belief, there are no relevant facts or circumstances which could give rise to an organizational conflict of interest, as defined in FAR 2.101 and Subpart 9.5, and that the Contractor has disclosed all such relevant information. Prior to commencement of any work, the Contractor agrees to notify the Contracting Officer promptly that, to the best of its knowledge and belief, no actual or potential conflict of interest exists or to identify to the Contracting Officer any actual or potential conflict of interest the firm may have. In emergency situations, however, work may begin but notification shall be made within five (5) working days. The Contractor agrees that if an actual or potential organizational conflict of interest is identified during performance, the Contractor shall promptly make a full disclosure in writing to the Contracting Officer. This disclosure shall include a description of actions which the Contractor has taken or proposes to take, after consultation with the Contracting Officer, to avoid, mitigate, or neutralize the actual or potential conflict of interest. The Contractor shall continue performance until notified by the Contracting Officer of any contrary action to be taken. Remedies include termination of this contract for convenience, in whole or in part, if the Contracting Officer deems such termination necessary to avoid an organizational conflict of interest. If the Contractor was aware of a potential organizational conflict of interest prior to award or discovered an actual or potential conflict after award and did not disclose it or misrepresented relevant information to the Contracting Officer, the Government may terminate the contract for default, debar the Contractor from Government contracting, or pursue such other remedies as may be permitted by law or this contract.

H.6. NEEDLE DISTRIBUTION

The Contractor shall not use contract funds to carry out any program of distributing sterile needles or syringes for the hypodermic injection of any illegal drug.

H.7. RESTRICTION ON ABORTIONS

The Contractor shall not use contract funds for any abortion.

H.8. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH

The Contractor shall not use contract funds for (1) the creation of a human embryo or embryos for research purposes; or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR 46.204(b) and Section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b)). The term "human embryo or embryos" includes any organism, not protected as a human subject under 45 CFR 46 as of the date of the enactment of this Act, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells.

Additionally, in accordance with a March 4, 1997 Presidential Memorandum, Federal funds may not be used for cloning of human beings.

H.9. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION

The Contractor shall not use contract funds to disseminate information that is deliberately false or misleading.

H.10. MANUFACTURING STANDARDS

The Current Good Manufacturing Practice Regulations (cGMP) Regulations (21 CFR Parts 210-211) will be the standard to be applied for manufacturing, processing and packaging of this product.

If at any time during the life of the Contract, the Contractor fails to comply with cGMP in the manufacturing, processing and packaging of this product and such failure results in a material adverse effect on the safety, and purity of the product (a material failure) as identified by the FDA, the Contractor shall have thirty (30) calendar days from the time such material failure is identified to cure such material failure. If the Contractor fails to take such an action within the thirty (30) calendar day period, then the Contract may be terminated.

H.11. ACCESS TO DOCUMENTATION/DATA

The Government shall have physical and electronic access to all documentation and data generated under this contract, including: all data documenting Contractor performance; all data generated; all communications and correspondence with regulatory agencies and bodies to include all audit observations, inspection reports, milestone completion documents, and all Offeror commitments and responses. Contractor shall provide the Government with an electronic copy of all correspondence and submissions to the FDA within 5 business days of receipt. The Government shall acquire unlimited rights to all data funded or furnished without proprietary restrictions under this contract in accordance with FAR Subpart 27.4 and FAR Clause 52.227-14.

H.12. EPA ENERGY STAR REQUIREMENTS

In compliance with Executive Order 12845 (requiring Agencies to purchase energy efficient computer equipment), all microcomputers, including personal computers, monitors, and printers that are purchased using Government funds in performance of a contract shall be equipped with or meet the energy efficient low-power standby feature as defined by the EPA Energy Star program unless the equipment always meets EPA Energy Star efficiency levels. The microcomputer, as configured with all components, must be Energy Star compliant.

This low-power feature must already be activated when the computer equipment is delivered to the agency and be of equivalent functionality of similar power managed models. If the equipment will be used on a local area network, the vendor must provide equipment that is fully compatible with the network environment. In addition, the equipment will run commercial off-the-shelf software both before and after recovery from its energy conservation mode.

H.13. ACKNOWLEDGMENT OF FEDERAL FUNDING

Contractors funded with Federal dollars, in whole or in part, shall acknowledge Federal funding when issuing statements, press releases, requests for proposals, bid solicitations and other documents. This requirement is in addition to the continuing requirement to provide an acknowledgment of support and disclaimer on any publication reporting the results of a contract funded activity. The Offeror shall acknowledge the support of the Department of Health and Human Services, Administration for Strategic Preparedness and Response, Center for the Biomedical Advanced Research and Development Authority whenever publicizing the work under this contract in any media by including an acknowledgment substantially as follows: “This project has been funded in whole or in part with Federal funds from the Administration for Strategic Preparedness and Response, Center for the Biomedical Advanced Research and Development Authority, under Contract No. 75A50126C00003”.

Publication and Publicity (Not Including Press Releases)

No information related to data obtained under this contract shall be released or publicized without providing BARDA with at least thirty (30) days advanced notice and an opportunity to review the proposed release or publication.

In addition to the requirements set forth in HHSAR Clause 352.227-70, Publications and Publicity incorporated by reference in Section I of this contract, Contractors are required to state:

Press Releases

Misrepresenting contract results or releasing information that is injurious to the integrity of BARDA may be construed as improper conduct. Press releases shall be considered to include the public release of information to any medium, excluding peer-reviewed scientific publications. With the exception of ad-hoc press releases required by applicable law or regulations; the Contractor shall ensure that the COR has

received an advance copy of any press release related to the contract not less than five (5) business days prior to the issuance of the press release.

The Contractor shall acknowledge the support of the Department of Health and Human Service, Administration for Strategic Preparedness and Response, Center for the Biomedical Advanced Research and Development Authority, whenever publicizing the work under this contract in any media by including an acknowledgment substantially as follows:

“This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Center for the Biomedical Advanced Research and Development Authority, under Contract No. 75A50125C00012”

H.14. PROHIBITION ON THE USE OF APPROPRIATED FUNDS FOR LOBBYING ACTIVITIES AND HHSAR 352.203-70 ANTI-LOBBYING (December 2015)

Pursuant to the HHS annual appropriations acts, except for normal and recognized executive- legislative relationships, the Contractor shall not use any HHS contract funds for:

H.15. LABORATORY LICENSE REQUIREMENTS

The Contractor shall comply with all applicable requirements of Section 353 of the Public Health Service Act (Clinical Laboratory Improvement Act as amended) (42 U.S.C. 263a and 42 CFR Part 493). This requirement shall also be included in any subcontract for services under the contract.

H.16. QUALITY ASSURANCE (QA) AUDIT REPORTS

BARDA reserves the right to participate in QA audits as related to activities funded under this contract. Upon completion of the audit/site visit the Contractor shall provide a report capturing the findings, results and next steps in proceeding with the subcontractor. If action is requested of the subcontractor, detailed concerns for addressing areas of non-conformance to FDA regulations for GLP, GMP, or GCP guidelines, as identified in the audit report, must be provided to BARDA. The Contractor shall provide responses from the subcontractors to address these concerns and plans for corrective action execution.

H.17. BARDA AUDITS

Contractor shall accommodate periodic or reasonable ad hoc site visits during normal business hours by the Government with forty- eight (48) hours advance notice. If the Government, the Contractor, or other parties identifies any issues during an audit, the Contractor shall capture the issues, identify potential solutions, and provide a report to the Government.

H.18. RESTRICTION ON EMPLOYMENT OF UNAUTHORIZED ALIEN WORKERS

The Contractor shall not use contract funds to employ workers described in Section 274A (h)(3) of the Immigration and National Act, which reads as follows:

“(3) Definition of unauthorized alien – As used in this Section, the term ‘unauthorized alien’ with respect to the employment of an alien at a particular time, that the alien is not at that time either an alien lawfully admitted for permanent residence, or (B) authorized to be so employed by this Act or by the Attorney General.”

H.19. NOTIFICATION OF CRITICAL PROGRAMMATIC CONCERNS, RISKS, OR POTENTIAL RISKS

If any action occurs that creates a cause for critical programmatic concern, risk, or potential risk to BARDA or the Contractor and Incident Report shall be delivered to BARDA.

If corrective action is deemed necessary, Contractor must address in writing, its consideration of concerns raised by BARDA within 5 business days.

H.20. CONTINUED BAN ON FUNDING ABORTION AND CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH, HHSAR 352.270-13 (December 2015)

H.21. FOREIGN TRANSFER OF ASSETS OR TECHNOLOGY

This clause shall remain in effect during the term of the Contract and for five (5) years thereafter.

AFFILIATES: Associated business concerns, non-profit organizations, or individuals if, directly or indirectly, (1) either one controls or can control the other; or (2) a third party controls or can control both.

ASSET(S): Tangible or intangible manifestations of technologies having economic value and capable of being conveyed between economic or Governmental entities that is the focus/scope of development by the U.S. Government (“USG”) and Contactor in this Contract.

ASSET(S): Tangible or intangible manifestations of technologies having economic value and capable of being conveyed between economic or Governmental entities that is the focus/scope of development by the U.S. Government (the “USG”) and Contactor in this Contract.

FOREIGN FIRM OR INSTITUTION: A firm or institution organized or existing under the laws of a country other than the United States of America (U.S.), its territories, or possessions. The term includes, for purposes of this Contract, any agency or instrumentality of a foreign government; and firms, institutions or business organizations which are owned or substantially controlled by foreign governments, firms, institutions, or individuals.

TECHNOLOGY: Technical Data, Computer Software, manufactured materials and Subject Inventions funded by the USG under this Contract. Technology also includes contractor know how and personnel expertise, as well as other Assets necessary to assure successful completion of this Contract.

U.S. FIRM OR INSTITUTION: A firm or institution organized or existing under the laws of the United States, its territories, or possessions. The term includes, for purposes of this Contract, any agency or instrumentality of the USG; and firms, institutions or business organizations which are owned or substantially controlled by U.S. citizens, firms, institutions, governmental agencies or individuals.

The Parties agree that research findings and technological developments made under this Contract constitute an investment by the USG on behalf of its citizens in the interest of their economic and national health security. These investments are made for the primary benefit of the citizenry of the U.S. with those same benefits potentially accruing to the people of all nations. Therefore, the USG has a fiduciary responsibility to protect the full invested value of the Assets and Technology developed under this Contract. The USG is also cognizant of the duty the Contractor has to its shareholders and other stakeholders with a vested interested in the economic success of the Contractor. At times both parties are aware their respective interests may diverge. Therefore, in the course of conducting business though the Contract, access to technology developments under this Contract by Foreign Firms or Institutions must be carefully considered.

Contractor agrees to comply with all applicable laws regarding export controls and not to export any Asset or Technology to any U.S. embargoed countries.

The Contractor shall provide notice to the Contracting Officer and COR within three (3) business days of any discussions of a proposed transfer of ownership or establishment of a licensing agreement of any Asset or Technology funded under this Contract from the Contractor to a Foreign Firm or Institution.Notice will also be given within three (3) business days of any discussions of a proposed transfer of operational, corporate, or economic control of Assets and Technology funded under this Contract to Foreign Firms or Institutions. This Article shall not apply to transfers by the Contractor to Affiliated entities of the Contractor, as well as technology transfers for the purposes of manufacturing in accordance with the Statement of Work.

Prior to transferring any Asset funded by the USG under this Contract, the Contractor should carefully review the USG rights under FAR Subpart 42.9 - Novation and Change-of-Name Agreements, specifically FAR section 42.903 Applicability of novation agreements. That provision provides that the USG may recognize a third party assignment only if the transfer of Assets and Technology is determined to be in the USG’s interests. The Contractor should be aware that the USG is under no obligation to recognize a successor in interest. If the Contracting Officer determines that a transfer of Assets and Technology may have adverse consequences to the economic well-being or national health security interests of the U.S., the Contractor, and the Contracting Officer shall jointly endeavor to find alternatives to the proposed transfer which obviate or mitigate potential adverse consequences of the transfer but which may provide substantially equivalent benefits to the Contractor.

In addition to the USG licensing rights to subject inventions and technical data funded under this Contract, see FAR clause 52.227-11 (Patent Rights-Ownership by the Contractor) and FAR Clause 52.227-14 (Rights in Data - General), the USG shall have a first right of refusal for the purchase of the Asset and/or Technology funded under the Contract. The USG may waive this first right of refusal in writing submitted to the Contractor within ninety (90) calendar days of the initial notification to the USG of the Contractor’s intent to conduct any form of Asset or corporate transfer.

Except for transfers to affiliates of the Contractor, including those entities necessary to complete the Statement of Work, the Contractor shall provide written notice to the Contracting Officer and COR of the scheduled transfer to a Foreign Firm or Institution at least ninety (90) calendar days prior to the scheduled date of transfer. Such notice shall cite this Article and shall specifically identify the Asset or Technology proposed for the transfer and the general terms of the transfer. No transfer shall take place without written concurrence from the Contracting Officer.

In the event of a transfer of an Asset and/or Technology by the Contractor to a Foreign Firm or Institution which is identified as a Prohibited Source pursuant to Federal Acquisition Regulation Subpart 25.7: (a) the Government may terminate this contract for cause and (b) the license rights to the technical data and subject invention under the relevant FAR IP Clauses (FAR Clause 52.227-11 and FAR Clause 52-227-14) shall survive the termination. Upon request of the USG, the Contractor shall provide written confirmation of such licenses.

The Contractor shall include this Article, suitably modified, to identify the Parties, in all subcontracts or lower tier agreements, regardless of tier.

H.22. SUBCONTRACTING PROVISIONS (Not Required)

H.23. NOTICE PRIOR TO PUBLICATION

The Contractor shall not release any reports, manuscripts, press releases, or abstracts about the work being performed under this Contract without written advanced notice to the CO, provided that no such notice is required to comply with any law, rule, regulation, court ruling or similar order; for submission to any USG entity; for submission to any securities exchange on which the Contractor’s (or its parent corporation’s) securities may be listed for trading; or to third parties relating to securing, seeking, establishing, or maintaining regulatory or other legal approvals or compliance, financing and capital raising activities, or mergers, acquisitions, or other business transactions.

H.24. DISSEMINATION OF INFORMATION

No information related to data obtained under this Contract shall be released or publicized without the prior written notice to the CO, whose response shall not be unreasonably withheld, conditioned, or delayed, provided that no such consent is required to comply with any law, rule, regulation, court ruling or similar order; for submission to any USG entity for submission to any securities exchange on which the

Contractor’s (or its parent corporation’s) securities may be listed for trading; or to third parties relating to securing, seeking, establishing or maintaining regulatory or other legal approvals or compliance, financing and capital raising activities, or mergers, acquisitions, or other business transactions.

H.25. CERTIFICATION OF FILING AND PAYMENT OF TAXES

The Contractor must be in compliance with Section 518 of the Consolidated Appropriations Act of FY 2014.

H.26. CONFIDENTIALITY OF INFORMATION

H.27. INSPECTIONS & COLLECTION OF SAMPLES

At the discretion of the USG and independent of testing conducted by the Contractor, the USG reserves the right to conduct site visits and collect samples of Product held by the Contractor. The USG reserves the right to conduct inspections of all aspects of the contracted project including, but not limited to, the manufacturing plant and production records, testing and development laboratories, regulatory files and QMS records.

H.28. REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF CONTRACTORS

The Representations, Certifications and Other Statements of Contractors submitted by the Contractor dated March 1 2013 are hereby incorporated by reference, with the same force and effect as if they were given in full text.

H.29. MATERIAL COMPLIANCE REQUIREMENT

Contractor agrees that full compliance with the terms of Executive Order Number 14292 titled Improving the Safety and Security of Biological Research (the “Order”) and any applicable regulations is material to the Government’s payment decisions for purposes of 31 U.S.C. § 3729(b)(4), consistent with existing laws and regulations.

H.30. CERTIFICATION REGARDING RESEARCH ACTIVITIES

By executing this contract, Contractor certifies that it does not operate, participate in, or fund any dangerous gain-of-function research or other life-science research conducted in foreign countries that could cause significant societal consequences or generate unnecessary national security risks, and that all such activities, if any, are in full compliance with the Order and the policies set forth therein.

H.31. INSTITUTIONAL RESPONSIBILITY FOR VIOLATIONS

The Contractor acknowledges and agrees that any individual who commits a violation of The Order or applicable regulations, that violation may be deemed a violation by the recipient’s employer or affiliated institution.

H.32. CONSEQUENCES OF NONCOMPLIANCE

The Contractor further acknowledges that any recipient, employer, or institution found to be in violation of the Order or applicable regulations may be subject to immediate revocation of ongoing Federal funding and may be rendered ineligible for Federal life-sciences grant funds offered by the Department of Health and Human Services and other relevant agencies for a period of up to five (5) years.

H.33. Compliance with Executive Order Number 14292:

Contractor agrees that full compliance with the terms of Executive Order Number 14292 titled Improving the Safety and Security of Biological Research (the “Order”) and any applicable regulations is material to the Government’s payment decisions for purposes of 31 U.S.C. § 3729(b)(4), consistent with existing laws and regulations.

By executing this contract, Contractor certifies that it does not operate, participate in, or fund any dangerous gain-of-function research or other life-science research conducted in foreign countries that could cause significant societal consequences or generate unnecessary national security risks, and that all such activities, if any, are in full compliance with the Order and the policies set forth therein.

The Contractor acknowledges and agrees that any individual who commits a violation of The Order or applicable regulations, that violation may be deemed a violation by the recipient’s employer or affiliated institution.

The Contractor further acknowledges that any recipient, employer, or institution found to be in violation of the Order or applicable regulations may be subject to immediate revocation of ongoing Federal funding and may be rendered ineligible for Federal life-sciences grant funds offered by the Department of Health and Human Services and other relevant agencies for a period of up to five (5) years.

PART II – CONTRACT CLAUSES

SECTION I – CONTRACT CLAUSES

FAR 52.252-2 Clauses Incorporated by Reference (Feb 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

Full text of the FAR clauses may be accessed electronically at:

https://www.acquisition.gov/far-overhaul/far-part-deviatiorn-guide

System updates may lag policy updates. The System for Award Management (SAM) may continue to require entities to complete representations based on provisions that are not included in agency solicitations, including 52.223-22, Public Disclosure of Greenhouse Gas Emissions and Reduction Goals—Representation, and paragraph (t) of 52.212-3, Offeror Representations and Certifications—Commercial Products and Commercial Services. Agencies will not consider or use these representations. Entities are not required to, nor are they able to, update their entity registration to remove these representations in SAM.

“System updates may lag policy updates. The System for Award Management (SAM) may continue to require entities to complete representations based on provisions that are not included in agency solicitations.

Full text of the HHSAR clauses can be found at https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

52.212-4 Terms and Conditions—Commercial Products and Commercial Services.

As prescribed in 12.205(b)(3), insert the following clause:

Terms and Conditions—Commercial Products and Commercial Services (Deviation Date)

(End of clause)

FAR 52.216-2 Economic Price Adjustment—Standard Supplies (Nov 2021)

(End of clause)

FAR 52.217-2 Cancellation Under Multi-year Contracts

Cancellation Under Multi-year Contracts (Oct 1997)

(End of clause)

FAR 52.217-6 Option for Increased Quantity (Mar 1989)

The Government may increase the quantity of supplies called for in the Schedule at the unit price specified. The Contracting Officer may exercise the option by written notice to the Contractor within 15-days. Delivery of the added items shall continue at the same rate as the like items called for under the contract, unless the parties otherwise agree.

(End of clause)

PART III – ATTACHMENTS

SECTION J – LIST OF ATTACHMENTS

The following Attachments are provided with this Solicitation:

Attachment #1 Statement of Work (SOW)

FDA-Approved Autograft Sparing Device for National Preparedness

This Statement of Work (SOW) defines the tasks, deliverables, service levels, and acceptance criteria for AVITA Medical’s provision of FDA-approved RECELL® devices under an Access-Maintenance model for national preparedness. The SOW is organized by Contract Line Item Number (CLIN) and aligns with the structure and pricing described in Volume III – Business Proposal. Unless otherwise directed by the Contracting Officer (CO), this SOW governs the execution of work under the awarded contract.

See Appendix A (Past Performance & Utilization) and Appendix B (Sales Velocity) for supporting data.

AVITA Medical will maintain, rotate, and deploy RECELL devices for rapid response to burn mass casualty incidents and surge scenarios. Objectives include: maintaining [***] units; providing 24-hour deployment readiness; conducting mock deployments; and scaling manufacturing capacity to meet surge procurement as directed by the USG.

Access-Maintenance: Commercially held inventory designated for USG right-of-first-access and immediate procurement.

BARDA: Center for the Biomedical Advanced Research and Development Authority.

CO/COR: Contracting Officer / Contracting Officer’s Representative.

QMS/QSR: Quality Management System / 21 CFR 820 Quality System Regulation.

RECELL Devices: FDA-approved RECELL systems and kits offered under this contract (e.g., RECELL GO, GO Mini, Ease-of-Use).

AVITA Medical manufacturing and warehousing sites (Ventura, CA) and other qualified facilities as necessary to perform packaging and shipment. Deployments will be shipped to USG-designated receiving sites.

AVITA Medical shall provide the following reports, unless otherwise directed by the CO/COR:

AVITA shall maintain an ISO 13485-compliant Quality Management System aligned with 21 CFR 820. All activities covered by this SOW shall follow cGMP and GDP practices, validated processes, and change control. Electronic systems impacting quality data shall remain validated and compliant. AVITA shall maintain physical security and cybersecurity controls consistent with its Security Plan (e.g., access control, CCTV, ISO 27001-aligned IT controls).

Emergency shelf-life: For deployments under CLIN 003 and CLIN 005, all devices shipped to the USG will have at least three (3) months of remaining shelf-life at time of shipment.

Provide immediate procurement access to up to [***] RECELL devices held in AVITA’s Access-Maintenance inventory.

Acceptance: USG acceptance upon verification of report completeness and confirmed receipt at designated site(s).

Not applicable.

Hold, rotate, and report on [***] Access‑Maintenance units; sustain validated packaging and shipping readiness; maintain 24/7 emergency contact availability; and support mock deployment exercises and audits.

Acceptance: USG acceptance of reports and completion of exercises per the schedule.

Not applicable.

See Appendix A (Past Performance & Utilization) and Appendix B (Sales Velocity) for supporting data.

Packaging and shipment readiness for the initial [***] units, including execution of up to three (3) mock deployment exercises over the PoP. Upon USG activation, package and ship to designated sites within 24 hours.

Acceptance: USG acceptance upon delivery confirmation and receipt of required reports.

$[***]; Shipping ([***] units): $[***] (flat-rate scenario).

See Appendix A (Past Performance & Utilization) and Appendix B (Sales Velocity) for supporting data.

Upon USG surge procurement, AVITA will ramp manufacturing, packaging, sterilization, and QA release for up to [***] additional units. A delivery schedule will be provided within five (5) business days of the surge order.

See Appendix A (Past Performance & Utilization) and Appendix B (Sales Velocity) for supporting data.

Ambient‑condition packaging and shipment (or staging for SNS pick‑up) of surge units produced under CLIN 004. Upon USG activation, package and handoff per the agreed deployment plan.