Attachment E - Draft Agreement (Terms and Conditions) (15 Apr 2024).docx

Attachment E - Draft Agreement (Terms and Conditions)

OTHER TRANSACTION AGREEMENT FOR PROTOTYPE

BETWEEN

ABC, INC. (Performer) Performer Address City, State Zip

And

U.S. ARMY MEDICAL RESEARCH AND DEVELOPMENT COMMAND (USAMRDC)

Through

THE U.S. ARMY MEDICAL RESEARCH ACQUISITION ACTIVITY (USAMRAA)

820 Chandler Street Fort Detrick, MD 21702-5000

Effective Date: ____________

Agreement No.:

Total Amount of the Agreement:

Government Dollars:

Non-Government Dollars:

Funds obligated:

Authority: 10 U.S.C §4022

Line of Accounting and Appropriation: TBD

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 USAMRDC/USAMRAA, and (INERT Company Name) pursuant to and under the United States Federal law.

FOR (Insert Company Name) FOR THE GOVERNMENT

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 GENERAL PROVISIONS

ATTACHMENTS

ATTACHMENT 1 Statement of Work (including deliverables) ATTACHMENT 2 Milestone Schedule ATTACHMENT 3 Report Requirements ATTACHMENT 4 FDA Regulatory Process and Correspondence ATTACHMENT 5 Performer Background Intellectual Property, Technical Data, and Other Terms ATTACHMENT 6 Foreign Enclosure 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 provision 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 multiplexed clinical assays for use in military combat operations to test blood donors. The multiplex panel(s) will use whole blood samples to test for HIV-1 and -2, Hepatitis B and C, blood type and Rh factor, and will be used to screen donors prior to collecting whole blood for emergency blood transfusions. The technology must reliably operate under highly variable environmental and physical conditions to be effective where US Service Members are deployed. The technology must achieve FDA approval for donor screening; approval of waiver of the Clinical Laboratory Improvement Amendment (CLIA) requirements is highly desirable due to the varied skill sets of personnel conducting testing during deployments.

B. Definitions

Agreement: The body of this Agreement and Attachments 1-6, which are expressly incorporated in and made a part of the Agreement.

Agreement Officer (AO): A warranted individual with the authority to enter into, administer, or terminate OTs.

Agreement Officer Representative (AOR): A person designated by the Agreements Officer to be responsible for managing the scientific and technical aspects of this Agreement and assisting with Agreement administration. This individual does NOT have the authority to enter into or terminate an OT.

Agreement Specialist (AS): An individual who works along side the Agreement Officer who may write and finalize a Federal organizations agreements with Performers. This individual does NOT have the authority to enter into or terminate an OT.

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.

Cost sharing: Cost sharing occurs when a portion of the total cost of the project is paid out of funds provided by sources other than the Federal Government. Contributions can be in cash or non-cash form, and costs can be either direct or indirect, so long as they are allowable, allocable, reasonable, and consistently accounted for by the performer. Resource sharing may include labor, materials, equipment, IP rights, and facilities. Foregone fee or profit on another contract or agreement or cost of money is NOT consistent with general cost principles and will NOT be permitted. Profit or fee must NOT be included in resource-shared agreements. Types of cost sharing:

Cash Contribution: Any contribution of funds, services, or materials for which the Recipient 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.

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.

Data: Recorded information, regardless of form or method of recording, which includes but is not limited to, Technical Data, software, mask works and trade secrets. The term does not include financial, administrative, cost, pricing or management information and does not include OT inventions described in Article 8.

Expenditure-based OT: Agreements where payment are exclusively or primarily based on amount generated from the Performer’s financial or cost records.

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.

Government: The United States of America, as represented by USAMRDC and USAMRAA. It also means any executive agency as defined in section 105 of title 5 and the military departments as defined in section 102 of such title, as well as any agency of the legislative branch of the Federal Government.

Government Purpose Rights: The rights to—

(i) Use, modify, reproduce, release, perform, display, or disclose Technical Data within the Government without restriction; and

(ii) Release or disclose Technical Data outside the Government and authorize persons to whom release or disclosure has been made to use, modify, reproduce, release, perform, display, or disclose that data for United States government purposes.

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.

Invention: Invention has the meaning set forth in Title 15 U.S.C. §3703(7).

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.

Limited Rights: The rights to use, modify, reproduce, release, perform, display, or disclose Technical Data, in whole or in part, within the Government. The Government may not, without the written permission of the party asserting limited rights, release or disclose the Technical Data outside the Government, use the Technical Data for manufacture, or authorize the Technical Data to be used by another party, except that the Government may reproduce, release, or disclose such data or authorize the use or reproduction of the data by persons outside the Government if—

(i) The reproduction, release, disclosure, or use is—

(A) Necessary for emergency repair and overhaul; or

(B) A release or disclosure to—

(1) A covered Government support contractor in performance of its covered Government support contract for use, modification, reproduction, performance, display, or release or disclosure to a person authorized to receive limited rights Technical Data;

or

(2) A foreign government, of Technical Data other than detailed manufacturing or process data, when use of such data by the foreign government is in the interest of the Government and is required for evaluation or informational purposes;

(ii) The recipient of the Technical Data is subject to a prohibition on the further reproduction, release, disclosure, or use of the Technical Data; and

(iii) The contractor or subcontractor asserting the restriction is notified of such reproduction, release, disclosure, or use.

Made: Made has the meaning set forth in Title 15 U.S.C. §3703(8).

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

Non-Traditional Defense Contractor (NDC) –An entity that is not currently performing and has not performed, for at least one-year period preceding the solicitation of sources by the Department of Defense (DoD) for the procurement or transaction, any contract or subcontract for the DoD that is subject to full coverage under the cost accounting standards (CAS) prescribed pursuant to section 1502 of title 41 and the regulations implementing such section (see 10 U.S.C. §3014). The phrase “the solicitation of sources” refers to the initial agreement solicitation only. A nontraditional defense contractor is considered a nontraditional defense contractor for the duration of the prototype project/agreement’s period of performance, or for any in-scope work modified under the same agreement.

NOTE: Per the statutory definition, NDCs are all entities that have not performed under a narrowly defined set of circumstances within one year of solicitation of the current OT opportunity. In order for an entity to qualify for NDC status, it would need to meet all elements of the prescribed definition within that time period. This includes performance of a DoD contract or subcontract subject to full CAS coverage within one year prior to solicitation of the Prototype OT opportunity. The effect of this narrow definition is that many entities will fall into the NDC category, including nearly all small business concerns, and even those firms that work exclusively with DoD. This is in part due to the exemptions to CAS coverage under 41 U.S.C. §1502 and FAR Part 30, which exempt commercial contracts, Firm Fixed Price contracts based on adequate price competition, and any contract or subcontract with a small business concern, among other exemptions. Further, even where an entity is not outright exempt from CAS coverage, the entity may not have been subject to “full” CAS coverage. This is because full CAS coverage applies only to firms that receive a single CAS-covered contract award of $50 million or more; or received $50 million or more in net CAS-covered awards during its preceding cost-accounting period.

Significant extent – The Government will consider the totality of the circumstances for EACH proposed prototype project before making a determination as to the significance of expected NDC or nonprofit research institute participation. The government will weigh/consider elements such as, but not limited to, whether the NDC/nonprofit research institution will supply a new key technology, product, or process; supply a novel application or approach to an existing technology, product, or process; provide a material increase in the performance, efficiency, quality, or versatility of a key technology, product, or process; accomplish a significant amount of the prototype project; cause a material reduction in the cost or schedule of the prototype project; or, provide for a material increase in performance of the prototype project. The following are some, but not all, examples of participation to a significant extent:

1. Supplying a new key technology, product or process.

2. Supplying a novel application or approach to an existing technology, product or process.

3. Providing a material increase in the performance, efficiency, quality or versatility of a key technology, product or process.

4. Accomplishing a significant amount of the prototype project.

5. Causing a material reduction in the cost or schedule of the prototype project

6. Providing for a material increase in performance of the prototype project.

Party: Includes the Government (represented by USAMRDC/USMRAA), or the Performer, or both.

Parties: The United States of America, as represented by USAMRDC/USAMRAA, 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.

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 D.

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).

OT Invention: Any Invention Made in the performance of work under this Agreement. OTA Inventions may be Made by employees or contractors or others working on behalf of the Performer, the Government, or any combination thereof.

Sub-Performer/Awardee: The legal entity to which a Sub-award 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, even if the agreement is 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.

Restricted Rights: Restricted Rights apply only to other than commercial computer software and mean the Government's rights as defined in 48 CFR and below:

(i) Use a computer program with one computer at one time. The program may not be accessed by more than one terminal or central processing unit or time shared unless otherwise permitted by this contract;

(ii) Transfer a computer program to another Government agency without the further permission of the Contractor if the transferor destroys all copies of the program and related computer software documentation in its possession and notifies the licensor of the transfer. Transferred programs remain subject to the provisions of this clause;

(iii) Make a reasonable number of copies of the computer software required for the purposes of safekeeping (archive), backup, or modification, or other activities authorized in paragraphs (a)(15)(i), (ii), and (iv) through (vii) of this clause;

(iv) Modify computer software provided that the Government may—

(A) Use the modified software only as provided in paragraphs (a)(15)(i) and (iii) of this clause; and

(B) Not release or disclose the modified software except as provided in paragraphs (a)(15)(ii), (v), (vi) and (vii) of this clause;

(v) Use, and permit contractors or subcontractors performing service contracts (see 37.101 of the Federal Acquisition Regulation) in support of this or a related contract to use computer software to diagnose and correct deficiencies in a computer program, to modify computer software to enable a computer program to be combined with, adapted to, or merged with other computer programs or when necessary to respond to urgent tactical situations, provided that—

(A) The Government notifies the party which has granted restricted rights that any such release or disclosure to particular contractors or subcontractors was made;

(B) Such contractors or subcontractors are subject to the use and nondisclosure agreement at 227.7103-7 of the Defense Federal Acquisition Regulation Supplement (DFARS) or are Government contractors receiving access to the software for performance of a Government contract that contains the clause at DFARS 252.227-7025 , Limitations on the Use or Disclosure of Government-Furnished Information Marked with Restrictive Legends;

(C) The Government shall not permit the recipient to decompile, disassemble, or reverse engineer the software, or use software decompiled, disassembled, or reverse engineered by the Government pursuant to paragraph (a)(15)(iv) of this clause, for any other purpose; and

(D) Such use is subject to the limitations in paragraphs (a)(15)(i) through (iii) of this clause;

(vi) Use, and permit contractors or subcontractors performing emergency repairs or overhaul of items or components of items procured under this or a related contract to use, the computer software when necessary to perform the emergency repairs or overhaul, or to modify the computer software to reflect the repairs or overhaul made, provided that—

(A) The intended recipient is subject to the use and nondisclosure agreement at DFARS 227.7103-7 or is a Government contractor receiving access to the software for performance of a Government contract that contains the clause at DFARS 252.227-7025 , Limitations on the Use or Disclosure of Government-Furnished Information Marked with Restrictive Legends;

(B) The Government shall not permit the recipient to decompile, disassemble, or reverse engineer the software, or use software decompiled, disassembled, or reverse engineered by the Government pursuant to paragraph (a)(15)(iv) of this clause, for any other purpose; and

(C) Such use is subject to the limitations in paragraphs (a)(15)(i) through (iii) of this clause; and

(vii) Use, modify, reproduce, perform, display, or release or disclose computer software to a person authorized to receive restricted rights computer software for management and oversight of a program or effort, and permit covered Government support contractors in the performance of covered Government support contracts that contain the clause at 252.227-7025 , Limitations on the Use or Disclosure of Government-Furnished Information Marked with Restrictive Legends, to use, modify, reproduce, perform, display, or release or disclose the computer software to a person authorized to receive restricted rights computer software, provided that—

(A) The Government shall not permit the covered Government support contractor to decompile, disassemble, or reverse engineer the software, or use software decompiled, disassembled, or reverse engineered by the Government pursuant to paragraph (a)(15)(iv) of this clause, for any other purpose; and

(B) Such use is subject to the limitations in paragraphs (a)(15)(i) through (iv) of this clause.

Subject data: means Technical Data generated, directly or indirectly, related to the work performed under this contract).

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.

U.S. Army Medical Research and Development Command (USAMRDC) is a medical materiel developer with responsibility for medical research, development, and acquisition. Located in Frederick, MD at Fort Detrick.

U.S. Army Medical Research Acquisition Activity (USAMRAA) is the contracting organization in USAMRDC. USAMRAA is the authorized representative of the Department of the Defense to contract and administer this Agreement. Located in Frederick, MD at Fort Detrick.

C. Scope

1. The principal purpose of this Agreement is to engage in a research and development program for the development of multiplexed clinical assays for use in military combat operations to test blood donors. The multiplex panel(s) will use whole blood samples to test for HIV-1 and -2, Hepatitis B and C, blood type and Rh factor. It will be used to screen donors prior to collecting whole blood for emergency blood transfusions. The technology must achieve FDA approval for donor screening; approval of waiver of the Clinical Laboratory Improvement Amendment (CLIA) requirements is highly desirable due to the varied skill sets of personnel conducting testing during deployments.

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 3 Report Requirements.

3. This Agreement is a cost reimbursable plus fixed fee 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 2 and the procedures of Article 4. The Milestone Schedule maybe be revised or updated in accordance with Article 4.

4. Follow-on requirement for future expansion may be needed of the multiplex include targets of 10 or more. Examples include syphilis (T. pallidum), Human T-lymphotropic virus type 1 (HTVL I) and type II (HTLV II), Trypanosoma cruzi (Chagas disease) and low-titer O (defined as no greater than 1:250 anti-A and anti-B). However, this is not part of the scope for this requirement and is only intended to provide insight into potential future efforts.

D. Purpose

1. The purpose of this Agreement is to develop multiplexed assays that are FDA-cleared for a donor screening indication. Assays will use whole blood samples to detect HIV-1 and -2, Hepatitis B and C, blood type and Rh (Rhesus) factor in one or no more than 2 multiplex panels. The assays must provide results in 20 minutes or less and operate reliably under challenging environmental (temperature and humidity extremes) and physical (shock and vibration) conditions. Due to the space and weight constraints on medical equipment sets, a small technology is highly desirable. A complete list of attributes with minimum and optimal performance measures is provided in Statement of Objectives (SOO) and Objectives to Performance Attributes Crosswalk. The Statement of Work, Attachment 1, describes the scope of activities that will be undertaken by the Performer to achieve the objectives.

ARTICLE 2. Term and Termination.

A. Term of this Agreement.

1. The Base Period research effort commences upon the effective (last signature above) date and continues through the last delivery identified in the Milestone Schedule for the Base Period. The Milestone Schedule 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. The Base Period effort is planned for an estimated 2-year duration (period of performance) and subject to availability of funds. If all funds are expended prior to the completion of the period of performance, the Parties have no obligation to continue performance and may elect to cease development at that point.

2. If exercised, Optional Objectives 2 - 4 research efforts will commence upon effective (signature) dates of option exercises through the last deliveries identified in the Milestone Schedule for the Optional Objectives 2 – 4 research efforts.

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 primary 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 provisions 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 provisions 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 ninety (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 provisions 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.

If this Agreement is terminated for Cause, Performer will grant the Government a non-exclusive, paid up, perpetual license to the Performer and subawardee patents and documentation necessary for the purpose of developing the Prototype. The Performer shall provide the Government or its designee with a non-exclusive, paid up, license to any patent, copyright, technical data or regulatory information held by the Performer that relates to the technology to permit the Government to pursue commercialization of the technology with a third party, on terms to be agreed between the Parties and subject to rights granted or held by third parties. The terms of this section and the obligations herein will be included in any exclusive license given by the Performer to a third party for any intellectual property covered by this Agreement, on terms to be agreed between Performer and such third party. This clause will survive the acquisition or merger of the Performer by or with a third party.

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.

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 Agreement 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). The Performer will receive a copy of the written designation outlining the roles and responsibilities of the AOR and specifying the extent of the AOR’s authority to act on behalf of the pOTA. The AOR 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.

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 Agreement.

ARTICLE 4. AGREEMENT ADMINISTRATION.

This Agreement will be administered by USAMRAA. Unless otherwise provided in this Agreement, approvals permitted or required to be made by the Government may be made only by the USAMRAA AO. All such actions must be formalized by a proper contractual document executed by the 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):

808 Schreider Street Fort Detrick, MD 21702 Insert phone number Insert email address

Agreement Specialist (AS):

TBD

USAMRDC-USAMRAA

808 Schreider Street Fort Detrick, MD 21702 Insert Phone Number Insert Email Address

Agreements Officer’s Representative (AOR):

TBD

Insert phone number: TBD Insert email address: TBD

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

1.Insert Name, title, address, phone number and email address of POC Insert Name, title, address, phone number, and email address of alternate POC Performer Program Manager:

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

2. System for Award Management (Oct 2018)

(a) Definitions. As used in this provision—

"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) Company legal business name.

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

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

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

(5) Company telephone number.

(6) Date the company was started.

(7) Number of employees at your location.

(8) Chief executive officer/key manager.

(9) Line of business (industry).

(10) Company 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. This Agreement intends to preferably include completion of Objectives 1-4. However, Objectives 2-4 are optional objectives that may be exercised solely at the government’s discretion and is subject to the availability of appropriated funds.

2. This Agreement contains cost reimbursable options as detailed in the Statement of Work (Attachment 1), in which the Government evaluated at time of Agreement award.

3. 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.

4. The estimated duration of each optional objective is as follows:

Objective 2: 12 months Objective 3: 42 months Objective 4: 12 months

E. Sub-awardee Approval. Modifications to sub-awardees and/or new sub-awardees under this Agreement that could reasonably impact the technical approach proposed and accepted by the Government require prior AO approval. Sub-awardees proposed and agreed to during negotiations will be treated as having AO approval.

F. 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 Sub-awardee 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. 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.

G. 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.

If the Performer is currently performing under other expenditure-based (i.e., cost reimbursement) Federal procurement contracts OR assistance agreements/grants, the Performer is subject to the SAME standards for financial management/accounting systems that apply to those other Federal awards.

H. Final Indirect Cost Rates.

1. Final annual indirect cost rates and the appropriate bases shall be established for the period covered by the indirect cost rate proposal.

2. The Performer shall submit an adequate final indirect cost rate proposal to the AO or cognizant Federal agency official and auditor within the 6-month period following the expiration of each of its fiscal years. Reasonable extensions, for exceptional circumstances only, may be requested in writing by the Performer and granted in writing by the AO. The Performer shall support its proposal with adequate supporting data.

3. The proposed rates shall be based on the Performer’s actual cost experience for that period. The appropriate Government representative and the Performer shall establish the final indirect cost rates as promptly as practical after receipt of the Performer’s proposal4. Quick close-out procedures similar to those of the Federal Acquisition Regulation (FAR) 42.708 shall be followed.

4. Quick close-out procedures similar to those of the Federal Acquisition Regulation (FAR) 42.708 shall be followed.

I. Travel. The Performer shall be authorized travel expenses consistent with the substantive provisions of the applicable travel regulations and the limitation of funds specified in the agreement. Arrangements for all travel, transportation, meals, lodging, and incidentals are the responsibility of the Performer. All travel and transportation shall utilize commercial sources and carriers provided the method used for the appropriate geographical area results in reasonable charges to the Government. The Government shall not pay for business class or first-class travel.

J. 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 Comptroller General may examine in the exercise of the right referred to in that subparagraph are records of the same type as the records that the government has had the right to examine under the audit access clauses of the previous agreements or transactions referred to in such subparagraph that were entered into by that particular Party, entity, or subordinate element.

(3) This clause shall not be construed to require any Party or entity, or any subordinate element of such Party or entity that participates in the performance of the Agreement, to create or maintain any record that is not otherwise maintained in the ordinary course of business or pursuant to a provision of law.

(4) The Comptroller General shall have access to the records described in this clause until three years after the date the final payment is made by the United States under this Agreement.

(5) The recipient of the agreement shall flow down this provision to any entity that participates in the performance of the Agreement.

K. Title and Disposition of Acquired Property.

Not Applicable.

L. Flow down. The Performer shall include Articles 1,6 through 13, suitably modified, to identify all parties, in all sub-tier awards or other forms of lower tier agreements, regardless of tier. The Government will be a third party in interest for purposes of this Article in any agreement where flow-down of rights and obligations is required.

ARTICLE 5. Disputes

A. Dispute Resolution Process. The Parties recognize that disputes relating to their rights and obligations hereunder may arise from time to time during the term of this Agreement. It is the objective of the Parties to establish procedures to facilitate the resolution of disputes arising under this Agreement in an expeditious manner by mutual cooperation. To accomplish this objective, the Parties agree to follow the procedures set forth in this Article if and when a dispute arises under this Agreement.

1. Whenever disputes, disagreements, or misunderstandings arise, the Parties shall attempt to resolve the issue(s) involved by discussion and mutual agreement as soon as practicable. In no event shall a dispute, disagreement or misunderstanding which arose more than three (3) months prior to the written notification made under subparagraph A.2 of this article be subject for relief under this article unless the USAMRAA Ombudsman in the interest of justice, waives this requirement.

2. Failing resolution by mutual agreement, the aggrieved Party shall document the dispute, disagreement, or misunderstanding by notifying the other Party (through their respective AO or the Performer representative as the case may be) in writing documenting the relevant facts, identifying unresolved issues, specifying the clarification or remedy sought, and documenting the rationale as to why the clarification/remedy is appropriate. Within ten (10) working days after providing notice to the other Party, the aggrieved Party may, in writing, request a decision by the USAMRAA Ombudsman. The other Party shall submit a written position on the matter(s) in dispute within thirty (30) calendar days after being notified that a decision has been requested. The USAMRAA Ombudsman, will conduct a review of the matter(s) in dispute and render a decision in writing within thirty (30) calendar days of receipt of such position. Any such decision is final and binding, unless a Party shall, within thirty (30) calendar days request further review as provided by this article.

3. If requested within thirty (30) calendar days of the Ombudsman’s decision, further review will be conducted by the USAMRAA Senior Contracting Official (SCO). In the event of a decision, or in absence of a decision within sixty (60) calendar days of referral to the SCO, either Party may pursue any right or remedy provided by law. Alternatively, the parties may agree to explore and establish an Alternate Disputes Resolution procedure to resolve this dispute.

4. Limitation of Damages. Claims for damages of any nature whatsoever pursued under this Agreement shall be limited to direct damages only up to the aggregate amount of Government funding disbursed as of the time the dispute arises. In no event will either Party be liable to the other Party or any third party claiming through such Party for any indirect, incidental, consequential, punitive, or special damages, or claims for lost profits, arising under or relating to this Agreement, whether based in contract, tort or otherwise.

ARTICLE 6. Financial Matters

This Agreement is a cost plus fixed fee (CPFF) prototype Other Transaction Authority Agreement. Payments are intended to compensate the Performer on a CPFF basis for performance under this Agreement.

A. Obligation.

1. The Government’s liability to make payments to the Performer is limited to only those funds obligated under the Agreement or by modification to the Agreement. The Government may obligate funds to the Agreement incrementally by modification.

a. The Government and Performer estimate that the Statement of Work described in Attachment 1 can only be accomplished with total funding of $XXXX. The Government's share for performance of the work under this Agreement is $XXXX . The Performer's share for performance of work under this Agreement is $XXXX. The Performer’s cost share portion is funded with 100% Cash Contributions, no In-Kind contributions are proposed.

b. The total amount of Government funding presently available for performance under this agreement is %XXX. This Agreement is incrementally/fully funded. Milestone XYZ are fully funded.