Attachment E

OTHER TRANSACTION AGREEMENT FOR

PROTOTYPE

BETWEEN

ABC, INC. (Performer)

Performer Address

City, State Zip

And

DEFENSE HEALTH AGENCY (DHA) OPERATION

MEDICAL (OPMED) WARFIGHTER PROTECTION

AND ACUTE CARE PROJECT MANAGEMENT

OFFICE (WPAC PMO)[

Through

THE DEFENSE HEALTH AGENCY CONTRACTING ACTIVITY (DHACA)

808 Schreider Street

Fort Detrick, MD 21702-5000

Effective Date: ____________

Agreement No.:

Total Amount of the Agreement:

Government Dollars:

Non-Government Dollars:

Funds obligated: $X Authority: 10 U.S.C. § 4022

Line of Accounting and Appropriation: See Section G of the SF26.

NOTE: The SF26 is used for the purpose of obligation of Government Funds. Although the form is prescribed in the FAR, any references to the FAR on the SF26 are not applicable to this agreement.

This Agreement is entered into between the United States of America, hereinafter called the

Government, represented by DEFENSE HEALTH AGENCY WARFIGHTER PROTECTION AND ACUTE CARE PROJECT MANAGEMENT OFFICE[ and DEFENSE HEALTH

AGENCY CONTRACTING ACTIVITY, and (PERFORMER NAME) pursuant to and under the United States Federal law.

Agreement No.

FOR (Insert Performer Name) FOR DHACA

(Signature) (Signature)

Name, title TBD Agreements Officer

TABLE OF CONTENTS

ARTICLES

ARTICLE 1 SCOPE OF THE AGREEMENT

ARTICLE 2 TERM AND TERMINATION

ARTICLE 3 PROGRAM MANAGEMENT

ARTICLE 4 AGREEMENT ADMINISTRATION

ARTICLE 5 DISPUTES

ARTICLE 6 PAYMENT

ARTICLE 7 BACKGROUND INTELLECTUAL PROPERTY

ARTICLE 8 OT INVENTIONS

ARTICLE 9 DATA RIGHTS

ARTICLE 10 REGULATORY RIGHTS

ARTICLE 11 PERSONNEL

ARTICLE 12 SCIENTIFIC PUBLICATIONS AND PRESS RELEASES

ARTICLE 13 CYBERSECURITY TERMS

ARTICLE 14 GENERAL TERMS

ATTACHMENTS

ATTACHMENT 1 Statement of Work (including deliverables) ATTACHMENT 2 Milestone Schedule

ATTACHMENT 3 FDA Regulatory Process and Correspondence ATTACHMENT 4 Performer Background Intellectual Property, Technical Data, and Other Terms

ATTACHMENT 5 Government Background Intellectual Property and Technical Data ATTACHMENT 6 Foreign Disclosure Agreement

ARTICLE 1 SCOPE OF THE AGREEMENT

A. Background

This Agreement is an “Other Transaction for Prototype” pursuant to 10 U.S.C. § 4022. For the avoidance of doubt, this Agreement is not a procurement contract, grant, or cooperative agreement. The Federal Acquisition Regulation (FAR) and the Defense Federal Acquisition

Regulation Supplement (DFARS) do not apply to this Agreement except for any term expressly referenced herein. This Agreement is not intended to be, nor will it be construed as, forming, by implication or otherwise, a partnership, a corporation, or other business organization. This Agreement is not subject to the Bayh-Dole Act, 35 U.S.C. §§ 200-212.

The Parties agree that the ultimate purpose of this Agreement is to develop a Barrier Combination product in support of the Battlefield Wound Infection Prevention and Treatment (BWI P&T) program. The Barrier Combination product is defined as being composed of both a physical barrier to protect a wound and an antibacterial and/or antifungal activity released from the barrier to prevent the spread of organisms and avoid systemic infections. This agreement aims to advance the development of novel medical countermeasures for the treatment of battlefield wounds.

B. Definitions

Adequate security: Means protective measures that are commensurate with the consequences and probability of loss, misuse, or unauthorized access to, or modification of information.

Agreement: Refers to the Other Transaction Agreement, as authorized under 10 U.S.C. 4022, between the Government and Performer. The body of this Agreement and Attachments 1-8, which are expressly incorporated in and made a part of the Agreement.

Agreements Officer (AO): The DHACA warranted Contracting/Grants Officer to sign the final Agreement for the Government.

Agreements Officer Representative (AOR): The individual designated by the AO on a per project basis to monitor all technical and administrative aspects. This individual does NOT have the authority to enter into or terminate an OT.

Agreement Specialist (AS): An individual who works alongside the AO who may draft the Agreement and communicate with Performers. This individual does NOT have the authority to enter into or terminate an OT.

American Security Drone Act-covered foreign entity: Means an entity included on a list that the

Federal Acquisition Security Council (FASC) develops and maintains and publishes in the System for Award Management (SAM) at https://www.sam.gov (section 1822 of Pub. L. 118-31, 41 U.S.C. 3901 note prec.).

Backhaul: Means intermediate links between the core network, or backbone network, and the small subnetworks at the edge of the network (e.g., connecting cell phones/towers to the core telephone network). Backhaul can be wireless (e.g., microwave) or wired (e.g., fiber optic, coaxial cable, Ethernet).

Cash Contribution: Any contribution of funds, services, or materials for which the Performer is required to pay cash and which would normally be authorized for reimbursement as a direct or indirect charge to the Agreement. Examples include provision of direct labor, raw materials, and associated indirect costs. Cash contribution does not include foregone profit or fee.

Close out: Close out is the process by which the Government determines that all applicable administrative actions and all required work have been completed by the Performer.

Compromise: Means disclosure of information to unauthorized persons, or a violation of the security policy of a system, in which unauthorized intentional or unintentional disclosure, modification, destruction, or loss of an object, or the copying of information to unauthorized media may have occurred.

Consultant: A person who provides valuable, specialized advice, opinions, or recommendations on a temporary or intermittent basis drawn from a high degree of broad administrative, professional, or technical knowledge. Advisory in nature.

Controlled Unclassified Information (CUI): Means unclassified information that requires safeguarding or dissemination controls, pursuant to and consistent with applicable law, regulations, and Government-wide policies. Instructions for the use, marking, dissemination, and storage of CUI can be found in DoD Instruction 5200.48, “Controlled Unclassified Information

(CUI).”

Cost/Resource Sharing: Means a portion of the total cost of the project is to be paid out of funds provided by sources other than the Federal Government. Contributions can be in cash or in-kind

(non-cash) form, and costs can be either direct or indirect, so long as the contributions are allowable, allocable, reasonable, and consistently accounted for by the awardee

Covered application: Means the social networking service TikTok or any successor application or service developed or provided by ByteDance Limited or an entity owned by ByteDance Limited.

Covered article, as defined in 41 U.S.C. 4713(k), means:

(1) Information technology, as defined in 40 U.S.C. 11101, including cloud computing services of all types;

(2) Telecommunications equipment or telecommunications service, as those terms are defined in section 3 of the Communications Act of 1934 (47 U.S.C. 153);

(3) The processing of information on a Federal or non-Federal information system, subject to the requirements of the Controlled Unclassified Information program (see 32 CFR part 2002); or

(4) Hardware, systems, devices, software, or services that include embedded or incidental information technology.

Covered defense information: Means unclassified controlled technical information or other information, as described in the Controlled Unclassified Information (CUI) Registry at http://www.archives.gov/cui/registry/category-list.html, that requires safeguarding or dissemination controls pursuant to and consistent with law, regulations, and Government wide policies, and is—

a. Marked or otherwise identified in the agreement, task order, or delivery order and provided to the Performer by or on behalf of DoW in support of the performance of the agreement; or

b. Collected, developed, received, transmitted, used, or stored by or on behalf of the Performer in support of the performance of the Agreement. Covered foreign country means The People’s Republic of China.

Covered Performer information system: Means an unclassified information system that is owned, or operated by or for, a Performer and that processes, stores, or transmits covered defense information.

Covered telecommunications equipment or services means—

(1) Telecommunications equipment produced by Huawei Technologies Company or ZTE Corporation (or any subsidiary or affiliate of such entities);

(2) For the purpose of public safety, security of Government facilities, physical security surveillance of critical infrastructure, and other national security purposes, video surveillance and telecommunications equipment produced by Hytera Communications

Corporation, Hangzhou Hikvision Digital Technology Company, or Dahua Technology Company (or any subsidiary or affiliate of such entities);

(3) Telecommunications or video surveillance services provided by such entities or using such equipment; or

(4) Telecommunications or video surveillance equipment or services produced or provided by an entity that the Secretary of Defense, in consultation with the Director of National

Intelligence or the Director of the Federal Bureau of Investigation, reasonably believes to be an entity owned or controlled by, or otherwise connected to, the government of a covered foreign country.

Critical technology means—

(1) Defense articles or defense services included on the United States Munitions List set forth in the International Traffic in Arms Regulations under subchapter M of chapter I of title 22, Code of Federal Regulations;

(2) Items included on the Commerce Control List set forth in Supplement No. 1 to part

774 of the Export Administration Regulations under subchapter C of chapter VII of title 15, Code of Federal Regulations, and controlled—

(i) Pursuant to multilateral regimes, including for reasons relating to national security, chemical and biological weapons proliferation, nuclear nonproliferation, or missile technology; or

(ii) For reasons relating to regional stability or surreptitious listening;

(3) Specially designed and prepared nuclear equipment, parts and components, materials, software, and technology covered by part 810 of title 10, Code of Federal Regulations (relating to assistance to foreign atomic energy activities);

(4) Nuclear facilities, equipment, and material covered by part 110 of title 10, Code of

Federal Regulations (relating to export and import of nuclear equipment and material);

(5) Select agents and toxins covered by part 331 of title 7, Code of Federal Regulations, part 121 of title 9 of such Code, or part 73 of title 42 of such Code; or

(6) Emerging and foundational technologies controlled pursuant to section 1758 of the Export Control Reform Act of 2018 (50 U.S.C. 4817).

Cyber Incident: Means actions taken through the use of computer networks that result in a compromise or an actual or potentially adverse effect on an information system and/or the information residing therein.

Cyber incident: Means actions taken through the use of computer networks that result in a compromise or an actual or potentially adverse effect on an information system and/or the information residing therein.

Cybersecurity Maturity Model Certification (CMMC): Means a framework for assessing and certifying a company’s cybersecurity practices.

CMMC Unique Identifier (CMMC UID): Means a unique 10-character ID assigned to each

CMMC assessment in the SPRS system.

Data: means recorded information, regardless of form or the media on which it may be recorded. The term includes technical data. computer software, mask works, and trade secrets.

The term does not include information incidental to agreement administration, such as financial, administrative, cost or pricing, or management information and does not include OT inventions described in Article 8.

Expenditure-based OT: Agreements where payments are exclusively or primarily based on amounts generated from the performer's financial or cost records.

FASC-prohibited unmanned aircraft system: Means an unmanned aircraft system manufactured or assembled by an American Security Drone Act—covered foreign entity.

FASCSA order: Means any of the following orders issued under the Federal Acquisition

Supply Chain Security Act (FASCSA) requiring removing covered articles from executive agency information systems or excluding one or more named sources or named covered articles from executive agency procurement actions, as described in 41 CFR 201-1.303(d) and

(e):

(1) The Secretary of Homeland Security may issue FASCSA orders that apply to civilian agencies, to the extent not covered by paragraph (2) or (3) of this definition.

This type of FASCSA order may be referred to as a Department of Homeland Security (DHS) FASCSA order.

(2) The Secretary of Defense may issue FASCSA orders that apply to the Department of Defense (DoD), also referenced as the Department of War (DoW) and national security systems other than sensitive compartmented information systems. This type of FASCSA order may be referred to as a DoW FASCSA order.

(3) The Director of National Intelligence (DNI) may issue FASCSA orders that apply to the intelligence community and sensitive compartmented information systems, to the extent not covered by paragraph (2) of this definition. This type of FASCSA order may be referred to as a DNI FASCSA order.

Federal Contract Information (FCI): Means information related to the agreement that is not intended for public release.

Foreign Firm or Institution: A firm or institution organized or existing under the laws of a country other than the United States, its territories, or possessions. The term includes, for purposes of this Agreement, 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.

Forensic analysis: Means the practice of gathering, retaining, and analyzing computer-related data for investigative purposes in a manner that maintains the integrity of the data.

Government: The United States Government, as represented by the Operation Medical

(OPMED) and the Defense Health Agency Contracting Activity.

Information System: Means a discrete set of information resources organized for the collection, processing, maintenance, use, sharing, dissemination, or disposition of information.

Information technology, as defined in 40 U.S.C. 11101(6)—

(1) Means any equipment or interconnected system or subsystem of equipment, used in the automatic acquisition, storage, analysis, evaluation, manipulation, management, movement, control, display, switching, interchange, transmission, or reception of data or information by the executive agency, if the equipment is used by the executive agency directly or is used by a company under a contract or transaction with the executive agency that requires the use—

(i) Of that equipment; or

(ii) Of that equipment to a significant extent in the performance of a service or the furnishing of a product;

(2) Includes computers, ancillary equipment (including imaging peripherals, input, output, and storage devices necessary for security and surveillance), peripheral equipment designed to be controlled by the central processing unit of a computer, software, firmware and similar procedures, services (including support services), and related resources; but

(3) Does not include any equipment acquired by a Federal contractor incidental to a Federal contract or transaction.

In-Kind Contribution: Any contribution of equipment, facilities, intellectual property, etc.

which is necessary for performance of the statement of work for which a usage or depreciation charge is normally assessed versus reimbursement of the actual costs for acquiring or providing the item. Examples include costs associated with the provision or rental of real property, special tooling or test equipment, and foregone licensing fees for software where the

Government has no pre-existing right to free use.

Intelligence community, as defined by 50 U.S.C. 3003(4): Means the following—

(1) The Office of the Director of National Intelligence;

(2) The Central Intelligence Agency;

(3) The National Security Agency;

(4) The Defense Intelligence Agency;

(5) The National Geospatial-Intelligence Agency;

(6) The National Reconnaissance Office;

(7) Other offices within the Department of Defense for the collection of specialized national intelligence through reconnaissance programs;

(8) The intelligence elements of the Army, the Navy, the Air Force, the Marine Corps, the Coast Guard, the Federal Bureau of Investigation, the Drug Enforcement Administration, and the Department of Energy;

(9) The Bureau of Intelligence and Research of the Department of State;

(10) The Office of Intelligence and Analysis of the Department of the Treasury;

(11) The Office of Intelligence and Analysis of the Department of Homeland Security;

or

(12) Such other elements of any department or agency as may be designated by the President or designated jointly by the Director of National Intelligence and the head of the department or agency concerned, as an element of the intelligence community.

Invention: Any invention or discovery which is or may be patentable or otherwise protectable under Title 35 of the United States Code.

Interconnection arrangements: Means arrangements governing the physical connection of two or more networks to allow the use of another’s network to hand off traffic where it is ultimately delivered (e.g., connecting a customer of telephone provider A to a customer of telephone company B) or sharing data and other information resources.

Know-How: All information including, but not limited to discoveries, formulas, materials, inventions, processes, ideas, approaches, concepts, techniques, methods, software, programs, documentation, procedures, firmware, hardware, technical data, specifications, devices, apparatus and machines.

Kaspersky Lab-covered article: Means any hardware, software, or service that—

(1) Is developed or provided by a Kaspersky Lab-covered entity;

(2) Includes any hardware, software, or service developed or provided in whole or in part by a Kaspersky Lab-covered entity; or

(3) Contains components using any hardware or software developed in whole or in part by a Kaspersky Lab-covered entity.

Made: Relates to any invention, or the conception or first actual reduction to practice of such invention.

Malicious software: Means computer software or firmware intended to perform an unauthorized process that will have adverse impact on the confidentiality, integrity, or availability of an information system. This definition includes a virus, worm, Trojan horse, or other code-based entity that infects a host, as well as spyware and some forms of adware.

Media: Means physical devices or writing surfaces including, but is not limited to, magnetic tapes, optical disks, magnetic disks, large-scale integration memory chips, and printouts onto which covered defense information is recorded, stored, or printed within a covered Performer information system.

Milestone Payments: Payments made to the Performer according to a schedule that is based on predetermined measures of technical progress or other defined milestones.

National security system, as defined in 44 U.S.C. 3552: Means any information system

(including any telecommunications system) used or operated by an agency or by a contractor of an agency, or other organization on behalf of an agency—

(1) The function, operation, or use of which involves intelligence activities; involves cryptologic activities related to national security; involves command and control of military forces; involves equipment that is an integral part of a weapon or weapons system; or is critical to the direct fulfillment of military or intelligence missions, but does not include a system that is to be used for routine administrative and business applications (including payroll, finance, logistics, and personnel management applications); or

(2) Is protected at all times by procedures established for information that have been specifically authorized under criteria established by an Executive order or an Act of

Congress to be kept classified in the interest of national defense or foreign policy.

Operationally critical support: Means supplies or services designated by the Government as critical for airlift, sealift, intermodal transportation services, or logistical support that is essential to the mobilization, deployment, or sustainment of the Armed Forces in a contingency operation.

Party: Includes the Government (represented by OPMED/DHACA), or the Performer, or both.

Parties: The Government as represented by OPMED/DHACA, and Performer are sometimes referred to herein individually as a “Party” and collectively as the “Parties.”

Performer: The legal entity executing this Agreement with the Government.

Plan of Action and Milestones (POA&M) means a documented plan to correct any cybersecurity weaknesses and meet the required standards.

Practical Application: To manufacture, in the case of a composition of product; to practice, in the case of a process or method, or to operate, in the case of a machine or system; and, in each case, under such conditions as to establish that the invention is capable of being utilized and that its benefits are, to the extent permitted by law or Government regulations, available to the public on reasonable terms.

Program: Research and development being conducted by the Performer, as set forth in Article 1, paragraph C.

Personal Property: Any tangible personal property other than property actually consumed during the execution of work under this agreement. For purposes of this article, "property" does not include the deliverable prototype of this agreement).

Operationally critical support: Means supplies or services designated by the Government as critical for airlift, sealift, intermodal transportation services, or logistical support that is essential to the mobilization, deployment, or sustainment of the Armed Forces in a contingency operat ion.

OT Invention: Any invention conceived or first actually reduced to practice in the performance of work under this Agreement.

Roaming: Means cellular communications services (e.g., voice, video, data) received from a visited network when unable to connect to the facilities of the home network either because signal coverage is too weak or because traffic is too high.

Sensitive compartmented information: Means classified information concerning or derived from intelligence sources, methods, or analytical processes, which is required to be handled within formal access control systems established by the Director of National Intelligence.

Sensitive compartmented information system means a national security system authorized to process or store sensitive compartmented information.

Source: Means a non-Federal supplier, or potential supplier, of products or services, at any tier.

Subcontractor: The legal entity to which a lower tier agreement is made and which is accountable to the Performer for the use of funds provided. The term includes the recipient of financial assistance when provided by any legal agreement, including agreements called a contract, but does not include a supplier of goods and services when the goods and services provided are not an integral part of the research project or program.

Subject data: Means technical data generated, directly or indirectly, related to the work performed under this contract).

Subsidiary: Means an entity in which more than 50 percent of the entity is owned directly by a parent corporation or through another subsidiary of a parent corporation.

Substantial or essential component: Means any component necessary for the proper function or performance of a piece of equipment, system, or service.

Supplier Performance Risk System: Means the online Government portal used to record and manage a company’s CMMC status and affirmation.

Technical data: Means recorded information, regardless of the form or method of the recording, of a scientific or technical nature (including computer software documentation). The term does not include computer software or data incidental to contract administration, such as financial and/or management information.

Technology: Discoveries, innovations, Know-How and inventions, whether patentable or not, including computer software, recognized under U.S. law as intellectual creations to which rights of ownership accrue, including, but not limited to, patents, trade secrets, mask works and copyrights developed under this Agreement.

Unlimited Rights: Rights to use, duplicate, release, or disclose, Data in whole or in part, in any manner and for any purposes whatsoever, and to have or permit others to do so.

Unmanned aircraft: Means an aircraft that is operated without the possibility of direct human intervention from within or on the aircraft (49 U.S.C. 44801(11)).

Unmanned aircraft system: Means an unmanned aircraft and associated elements (including communication links and the components that control the unmanned aircraft) that are required for the operator to operate safely and efficiently in the national airspace system (49 U.S.C.

44801(12)).

C. Scope

1. The principal purpose of this Agreement is to engage in a research and development program for the development of a Barrier Combination product.

2. In consideration for the Government providing funding under this Agreement, the

Performer will complete the prototype project as described in the Performer’s Statement of Work dated INSERT DATE, incorporated with changes herein and attached hereto as

Attachment 1. The Performer will submit or otherwise provide all documentation required by Attachment 2 Report Requirements.

3. This Agreement is a fixed-price OT. The Performer shall be paid a fixed amount for each milestone accomplished in accordance with the Milestone Schedule set forth in Attachment 3 and the procedures of Article 6. The milestone payments provided under this Agreement are not intended to compensate the Performer on a cost basis for performance under this Agreement. The Payable Milestone Schedule maybe be revised or updated in accordance with

Article 4.

OR

3. This Agreement is set up as expenditure-based adjustable milestone payment structure.

This Agreement is an expenditure-based OT. The Performer shall be paid for costs incurred based upon documented progress towards milestone completion in accordance with the

Milestone Schedule set forth in Attachment 3 and the procedures of Article 4. The Milestone Schedule maybe be revised or updated in accordance with Article 4.

D. Goals/Objectives

1. The goal of this Agreement is to advance the development of novel medical countermeasures for the treatment of battlefield wounds through a Barrier Combination product composed of both a physical barrier to protect a wound and an antibacterial and/or antifungal activity released from the barrier to prevent the spread of organisms and avoid systemic infections which includes achievement of the required attributes. . The Statement of Work, Attachment 1, describes the scope of activities that will be undertaken by the Performer to achieve the objective.

2. OPTIONAL: Interim Fielding Capability (IFC) for the developmental product. For the purpose of this Agreement, IFC means the Expanded Access use of an investigational product

[Battlefield Wound Infection – Barrier Combination] as a clinical formulation for DoD personnel in accordance with 21 C.F.R. Part 312 (for drugs or biologics) and/or 21 CFR 812 (for devices) as applicable, to the extent that such use has received any applicable 9119 regulatory approval required by law. The Government may require the use of [INSERT

SPECIFIC DRUG, BIOLOGIC, OR DEVICE NAME] for the indications being studied under this contract for IFC at any time, unless the Performer determines, on a case-by-case basis, that such Expanded Access use of [INSERT SPECIFIC DRUG, BIOLOGIC, OR DEVICE NAME] would not reflect the safe and appropriate use of the product, and any such use shall be subject to Performer having supply of product in sufficient quantity and quality.

3. OPTIONAL: As used herein, diseases caused by aggressive Multi-Drug-Resistant

Organisms (MDROs) and Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, and Enterobacter

(ESKAPE) pathogens shall collectively be deemed the “Battlefield Wound Infection – Barrier Combination.” If the Performer chooses not to develop and/or produce a Barrier Combination product for the treatment of the Battlefield Wound Infections, for reasons other than safety or efficacy concerns acknowledged by the FDA, and the Performer is not successful in efforts to find a third-party collaborator or partner that is willing to continue such development and/or production, the Performer will grant the Government or its designee a non-exclusive, non-sub licensable, paid up, perpetual license to the patents and documentation necessary for the purpose of developing and/or commercializing Barrier

Combination for the treatment of the Battlefield Wound Infections, under the terms and conditions set forth in Attachment 5. For the purpose of Attachment 5, “subject technology” means: the Barrier Combination product for the prevention and/or treatment of Battlefield Wound Infections targeted in the Statement of Work. For clarity, if the Performer chooses to develop and/or produce Barrier Combination for at least one disease that is a prevention and/or treatment of Battlefield Wound Infections, the Performer will have no obligation to grant the Government a license hereunder. This agreement involves an investigational product subject to regulation by the U.S. Food and Drug Administration (FDA) for which approval or clearance will be sought. Accordingly, the parties agree that the regulatory status and relationship will be governed by Attachment 5. Notwithstanding Article 2.D, the

Government’s rights and Performer’s obligations under this paragraph will cease to exist if this Agreement is terminated for any reason other than for Performer’s failure to materially comply with the terms of this Agreement.

ARTICLE 2 TERM AND TERMINATION

A. Term of this Agreement. This Agreement commences upon the date of the last signature above and extends through the date of last delivery identified in the Milestone Schedule, which may be updated from time to time, unless terminated pursuant to this Article 2; however, this Agreement may be extended upon mutual agreement of the Parties.

B. Termination for Convenience. Subject to a reasonable determination that this Agreement will not produce beneficial results commensurate with the expenditure of resources, the Government may terminate this Agreement by providing at least ninety (90) calendar days’ prior written notice to the Performer, provided that such written notice is preceded by consultation between the Parties. The Performer may terminate this Agreement upon providing written notice to the Government in the event that the significant subcontractor performing activities under the Statement of Work is no longer capable or willing to provide such services for Performer, and Performer is unable to find a suitable replacement. In the event of a termination of the Agreement, it is agreed that disposition of Data developed under this Agreement will be in accordance with the terms set forth in Article 8, Data Rights. The

Government and Performer will negotiate in good faith a reasonable and timely adjustment of all outstanding issues between the Parties as a result of termination, consistent with the terms of this Agreement. In the event of termination, nothing in this Agreement precludes the Performer from performing developmental work with other parties, using Performer’s own funds or other sources of funding to complete any terminated activities.

C. Termination for Cause. Except for a failure by the Government to pay the Performer, which shall be governed by the following sentence, if the Government materially fails to comply with the terms of this Agreement, the Performer, after issuance of a cure notice and failure of the Government to provide a plan to cure the defect within ten (10) calendar days or the time allowed by the Performer after the Government’s receipt of the cure notice, whichever is longer, may suspend performance of this Agreement. If the Government fails to pay Performer in accordance with the terms set forth in this Agreement, such failure shall be deemed to be a material breach of this Agreement, and the Performer may suspend performance of this Agreement if the Government fails to make payment within 90 days of satisfactory completion of a milestone. In addition, the Performer may terminate this Agreement if the Government fails to make payment within 180 days of satisfactory completion of a milestone.

If the Performer materially fails to comply with the terms of this Agreement, the Agreements Officer, after issuance of a cure notice and failure of the Performer to cure the defect within ten

(10) calendar days or the time allowed by the Agreements Officer after Performer’s receipt of the cure notice, whichever is longer, may take one or more of the following actions as appropriate:

(i) temporarily withhold payments pending correction of the deficiency,

(ii) disallow all or part of the cost of the activity or action not in compliance,

(iii) wholly or partly suspend or terminate this Agreement,

(iv) withhold further funding, or

(v) take any other legally available remedies.

D. Survival. Expiration or termination of this Agreement shall terminate all outstanding obligations and liabilities between the Parties arising from this Agreement except those described in Article 7, Article 8, and Article 9.

E. OPTIONAL: As used herein, diseases caused by Battlefield Wound Infections shall collectively be deemed “aggressive Multi-Drug-Resistant Organisms (MDROs) and

Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, and Enterobacter (ESKAPE) pathogens.” If the

Performer chooses not to develop and/or produce Barrier Combination (i.e. device with biologic) for the treatment of Battlefield Wound Infections, for reasons other than safety or efficacy concerns acknowledged by the FDA, and the Performer is not successful in efforts to find a third-party collaborator or partner that is willing to continue such development and/or production, the Performer will grant the Government or its designee a non-exclusive, non-sublicensable, paid up, perpetual license to the patents and documentation necessary for the purpose of developing and/or commercializing a Barrier Combination (i.e. device with biologic) for the prevention and/or treatment of the Battlefield Wound Infections, under the terms and conditions set forth in Attachment 4. Performer will have no obligation to grant the

Government a license hereunder. This agreement involves an investigational product subject to regulation by the U.S. Food and Drug Administration (FDA) for which approval or clearance will be sought. Accordingly, the parties agree that the regulatory status and relationship will be governed by Attachment 4. Notwithstanding Article 2.D, the Government’s rights and Performer’s obligations under this paragraph will cease to exist if this Agreement is terminated for any reason other than for Performer’s failure to materially comply with the terms of this Agreement.

ARTICLE 3 PROGRAM MANAGEMENT

A. Program Governance. The Performer is responsible for the overall management of the project development program and related program decisions. The Government and the Performer are bound to each other by a duty of good faith in achieving the Research Objectives. As such, the Government will have continuous involvement with the Performer. The Performer shall provide access to program results in accordance with Attachment 2, Report Requirements.

B. Program Management. The Performer and the Government will each designate an individual responsible for facilitating the communications, reporting, and meetings between the Parties. For the Performer the individual will serve as the Performer Project Manager, and for the Government the individual will be the Agreement’s Officer Representative (AOR).

C. Routine Program Updates. The Performer will provide routine program updates to the

AOR, in writing, at intervals set forth in Attachment 2.

D. Program Reviews. The Performer and the Government will hold quarterly program review meetings in accordance with the Statement of Work.

E. Regulatory Process Review and Participations. The Performer will lead regulatory activities with the FDA. The Performer will manage all regulatory communications, documentation, and submissions with health authorities in accordance with Attachment 4.

F. Reviews Resulting in Modifications. As a result of meetings, reviews, or at any time during the term of the Agreement, research progress or results may indicate that a change in the Statement of Work and or the Milestone Schedule would be beneficial to the program objectives.

Recommendations for modifications, including the rationale to support any changes to the

Statement of Work or Milestone Schedule, must be submitted in writing to the AO in accordance with Article 4. No communications, whether oral or in writing, that purport to change this

Agreement are valid unless a modification is issued by the AO to the Statement of Work or Milestone Schedule. The Government is not obligated to pay for additional or revised future milestones until the Milestone Schedule is formally revised by the AO and made part of this

ARTICLE 4 AGREEMENT ADMINISTRATION

This Agreement will be administered by the Defense Health Agency Contract Activity (DHACA).

Unless otherwise provided in this Agreement, approvals permitted or required to be made by the

Government may be made only by the DHACA AO. Administrative and contractual matters under this Agreement shall be referred to the following representatives of the parties:

A. Government Points of Contact.

Agreements Officer (AO):

TBD

DHACA – Contract Division 2 Agreement Specialist (AS):

Bryan G. Heickman DHACA – Contract Division 2 808 Schreider Street

Fort Detrick, MD 21702 Phone: 301-619-2622

Email: bryan.g.heickman.civ@health.mil

Agreements Officer’s Representative (AOR):

OPMED AOR - TBD

B. Performer Points of Contact and System for Award Management (SAM).

Insert Name, title, address, phone number, and email address

2. System for Award Management (Oct 2018)

(a) Definitions. As used in this term—

"Electronic Funds Transfer (EFT) indicator means a four-character suffix to the unique entity identifier. The suffix is assigned at the discretion of the commercial, nonprofit, or Government entity to establish additional System for Award Management records for identifying alternative

EFT accounts (see subpart 32.11) for the same entity.

Registered in the System for Award Management (SAM) means that–

(1) The Performer has entered all mandatory information, including the unique entity identifier and the EFT indicator, if applicable, the Commercial and Government Entity (CAGE) code, as well as data required by the Federal Funding Accountability and Transparency Act of

2006 (see subpart 4.14) into SAM

(2) The Performer has completed the Core, Assertions, and Representations and

Certifications, and Points of Contact sections of the registration in SAM;

(3) The Government has validated all mandatory data fields, to include validation of the Taxpayer Identification Number (TIN) with the Internal Revenue Service (IRS). The offeror will be required to provide consent for TIN validation to the Government as a part of the SAM registration process; and

(4) The Government has marked the record "Active".

Unique entity identifier means a number or other identifier used to identify a specific commercial, nonprofit, or Government entity. See www.sam.gov for the designated entity for establishing unique entity identifiers.

(b) (1) A Performer is required to be registered in SAM when submitting an offer or quotation, and shall continue to be registered until time of award, during performance, and through final payment of any contract, basic agreement, basic ordering agreement, or blanket purchasing agreement resulting from this solicitation.

(2) The Performer shall enter, in the block with its name and address on the cover page of its offer, the annotation "Unique Entity Identifier" followed by the unique entity identifier that identifies the Offeror's name and address exactly as stated in the offer. The Performer also shall enter its EFT indicator, if applicable. The unique entity identifier will be used by the Agreement Officer to verify that the Offeror is registered in the SAM.

(c) If the Performer does not have a unique entity identifier, it should contact the entity designated at www.sam.gov for establishment of the unique entity identifier directly to obtain one. The Offeror should be prepared to provide the following information:

(1) Performer/Company legal business name.

(2) Tradestyle, doing business, or other name by which your entity is commonly recognized.

(3) Performer/Company physical street address, city, state, and Zip Code.t

(4) Performer/Company mailing address, city, state and Zip Code (if separate from physical).

(5) Performer/Company telephone number.

(6) Date the Performer/Company was started.

(7) Number of employees at your location.

(8) Chief executive officer/key manager.

(9) Line of business (industry).

(10) Performer/ Performer headquarters name and address (reporting relationship within your entity).

(d) Processing time should be taken into consideration when registering. Performers who are not registered in SAM should consider applying for registration immediately upon receipt of this solicitation. See https://ww.sam.gov for information on registration.

C. Modifications. The only method by which this Agreement may be modified is by a formal, written modification signed by the AO and, if necessary, an authorized officer of the Performer.

1. Bilateral Modifications. The Performer or the Government may propose modifications to this

Agreement. A modification that materially changes the obligations of either Party must be in writing and signed by the AO and an authorized officer of the Performer. Performer requests for modification shall detail the technical, chronological, and financial impact of the proposed change on the Statement of Work.

2. Unilateral Modifications. The AO may unilaterally issue minor or administrative modifications, which do not materially change the obligations of the Performer, such as changes in the paying office or appropriation data, or changes to Government personnel identified in the Agreement.

Unilateral modifications will be signed only by the AO.

D. Options.

1. The Government has the unilateral right to exercise options of this Agreement any time during the period of performance; provided that the Government gives the Performer a preliminary written notice of its intent to extend at least 60 days before the agreement expires.

The preliminary notice does not commit the Government to an extension.

2. The total duration of this Agreement, including the exercise of any options under this article, shall not exceed 36 months.

E. Subcontract Approval. Modifications to subcontracts or lower tier agreements and/or new subcontracts under this Agreement that could reasonably impact the technical approach proposed and accepted by the Government require prior AO approval. Subcontracts proposed and agreed to during negotiations will be treated as having AO approval.

E. OPTIONAL (for Cost/Expenditure-based Agreements) Financial Records and Audit

Access. The costs incurred under this Agreement shall be those costs that are reasonable and prudent. Actual costs, including those direct costs associated with the Agreement as well as any indirect costs are reimbursable to the extent they have a significant relationship to providing the goods or service under the Agreement. The AO or authorized representative shall have direct access to sufficient financial records to ensure full accountability for all government funding or statutorily required cost share under the Agreement for a period of three (3) years after final payment, unless notified otherwise by the AO. The AO or authorized representative, shall have the right to examine or audit the Performer or subcontractor records during the period of the agreement and for three (3) years after final payment, unless otherwise notified by the AO. These records are also subject to examination or audit by Government auditors. Such audit, examination, or access shall be performed during business hours on business days upon prior written notice and shall be subject to the security requirements of the audited Party. OPTIONAL: The Performer shall provide a statement to the AO when a business unit meets the conditions for use of an

Independent Public Accountant (other than pursuant to the Single Audit Act) for any needed audits. The statement shall include the business unit's name, address, expected value of its award, and state the business unit is not currently performing on a procurement contract subject to the Cost Principles (48 CFR Part 31) and/or Cost Accounting Standards (48 CFR Part 99) and refuses to accept Government access to its records.

F. OPTIONAL (for Cost/Expenditure-based Agreements) Accounting System. The

Performer shall have and maintain established accounting systems, which comply with Generally Accepted Accounting Principles and shall ensure that appropriate arrangements have been made for receiving, distributing, and accounting for Federal funds. An adequate accounting system is normally accomplished through a job order cost accounting system, whereby the books and records segregate direct costs by agreement, and includes an established allocation method for the equitable allocation of indirect costs among agreements.

G. Title and Disposition of Acquired Property. The Performer must obtain approval from the

AO prior to purchasing property using Government funds. Property listed below is considered as having received AO approval for purchase.

Property Description Manufacturer/Source Anticipated Cost Anticipated Government Cost

1.Title to Property. Except as provided in this paragraph, title to property shall vest in the Performer upon acquisition. For those items of real property or nonexpendable personal property having a unit acquisition cost of $5,000 or more, which will be acquired with Government funds, the Government reserves the right to transfer the title to the Federal Government or to a third

Party named by the Government. If a Performer includes the use of real property or equipment that is purchased with non-federal funds or that is donated by a third party to meet a portion of any required cost sharing or matching, the Government will have a financial interest in the property equal to the Federal participation in the project and such property shall be subject to this Article.

2 . Disposition of Property. At the completion of the Research Project Award, items of property with an acquisition value greater than $5,000 shall be disposed of in the following manner:

a. Purchased by the Performer at an agreed-upon price, the price to represent fair market value, with the proceeds of the sale being returned to the Government. For Agreements with Cost Share, the Performer may elect to retain title, without further obligation to the Government, by compensating the Government for that percentage of the current fair market value of the real property or equipment that is attributable to the Federal participation in the project; or,

b. Transferred to a Government research facility with title and ownership being transferred to the Government or to an eligible third party. For Agreements with Cost Share, the Performer shall be entitled to compensation for its attributable percentage of the current fair market value of the real property or equipment, plus any reasonable shipping; or

c. Any other Government-approved disposition procedures. The Government shall provide disposition procedures within 120 days of being requested by the Performer to provide disposition. The Government is liable for storage costs of any property in storage awaiting disposition after this 120 day period.

H. Comptroller General Access to Records: The Comptroller General of the United States, in the discretion of the Comptroller General, shall have access to and the right to examine records of any Party to the Agreement, or any entity that participates in the performance of this Agreement, that directly pertain to, and involve transactions relating to, the Agreement.

(1) Excepted from the Comptroller General access requirement is any Party to this Agreement, or any entity that participates in the performance of the Agreement, or any subordinate element of such party or entity, that, in the year prior to the date of the Agreement, has not entered into any other contract, grant, cooperative agreement, or “other transaction” agreement that provides for audit access to its records by a government entity.

(2)(A) The right provided to the Comptroller General is limited as provided in subparagraph (B) in the case of a Party to the Agreement, any entity that participates in the performance of the Agreement, or a subordinate element of that Party or entity, if the only cooperative agreements or

"other transactions" that the party, entity, or subordinate element entered into with government entities in the year prior to the date of this Agreement are cooperative agreements or transactions that were entered into under 10 U.S.C. § 4022.

(B) The only records of a Party, other entity, or subordinate element referred to in subparagraph

(A) that the…