B08-HT9427-26-R-E001-Attachment-B-Draft-OTA-for-Prototype.docx

This Agreement is a draft only baseline two-party Agreement. No two OT’s are anticipated to be identical and you should anticipate changes and comments. When drafting your OT please use tracked changes for ease of review. Delete this and any other instructional text in red from your document. Adjust this page so that the signature fits on the first page.

OTHER TRANSACTION AGREEMENT FOR PROTOTYPE

BETWEEN

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

And

REQUIRING ACTIVITY

Through

THE DEFENSE HEALTH AGENCY

CONTRACTING ACTIVITY

808 Schreider 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: See Section G of the SF26. (Since we are using PD2 the LOA will populate from the PR into the award document, reference that section here. Do not duplicate the LOA here, as that creates the opportunity for error).

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 REQUIRING ACTIVITY and DEFENSE HEALTH AGENCY, RESEARCH AND DEVELOPMENT CONTRACTING, 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 FINANCIAL MATTERS

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 Report Requirements ATTACHMENT 3 Milestone Schedule ATTACHMENT 4 FDA Regulatory Process and Correspondence ATTACHMENT 5 Performer Background Intellectual Property, Technical Data, and Other Terms ATTACHMENT 6 Government Background Intellectual Property and Technical Data ATTACHMENT 7 Government Furnished Property (if applicable)

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 INSERT SUMMARY OF THE PURPOSE OF THE AGREEMENT HERE AND DEFINE THE PROTOTYPE PROJECT.

B. Definitions The AO should include definitions for any terms used in the OT. For example, if negotiating other than unlimited rights, then the AO will need to include the definitions of those terms. Terms that are not applicable should be deleted. For example, if cost-sharing is not used, the term along with cash contribution and in-kind should be deleted.

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. 4021/4022, between the Government and Performer. The body of this Agreement and Attachments 1-7, which are expressly incorporated in and made a part of the Agreement.

Agreements Officer (AO): The Defense Health Agency Contracting Activity warranted Contracting Officer authorized 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 Agreement Officer who may draft the Agreement and communicate with Performers. This individual does NOT have the authority to enter into or terminate an OT.

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.

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.

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.

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.

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.** Please check on changes in law or regulation that might add or remove a “covered” entity.”** 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 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 DoD 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.

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).”

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.

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 information incidental to agreement administration, such as financial, administrative, cost, 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.

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 Requiring Activity and the Defense Health Agency.

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

Information Technology:

(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 contractor under a contract 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 agreement.

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

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.

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.

Party: Includes the Government (represented by Requiring Activity/Defense Health Agency), or the Performer, or both.

Parties: The Government as represented by Requiring Activity/Defense Health Agency, 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).

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.

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

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).

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.

C. Scope

1. The principal purpose of this Agreement is to engage in a research and development program for the development of (DESCRIBE PROTOTYPE).

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 – See Below for Alternate Paragraph 3 language, use only the instructions applicable to your Agreement

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

This Agreement is an expenditure or cost reimbursable 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.

You are not required to use this payment structure. The use of milestones is intended to track and tie payment to technical progression. This also limits the Government’s risk by providing funding based on milestone progression. Cost type milestones can be more administratively heavy since the milestone cost and funding can be adjusted based on actual costs incurred. Other Payment structures could include:

If you use a different payment structure, you will need to make revisions throughout the Agreement. Namely, if you are not using a Milestone Schedule for payment, you would not need the Milestone Schedule attachment.

4. OPTIONAL (only if included in your solicitation): The Parties may negotiate a further agreement to cover performance of optional efforts solely connected to the need to complete delivery of non-FDA approved prototype doses that undergo and complete Phase 1 and/or Phase 2 trials including, if necessary to achieve these ends, coordination of appropriate animal studies and regulatory filings for a cost to be mutually agreed to by the Parties in good faith.

5. OPTIONAL (only if stated in your solicitation). This transaction hereby provides for the award of a follow-on production contract or transaction of the above described prototypes acquired under this transaction to the participants in this transaction subject to the requirements of 10 U.S.C. § 4022 (f)(2)(A) and (B) and (f)(3). Whenever possible consider the use of options or phases for follow-on production or research tasks.

D. Goals/Objectives

1. The goal of this Agreement is to (describe the ultimate outcome or goal of the program). 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 [INSERT SPECIFIC DRUG, BIOLOGIC, OR DEVICE NAME] as a clinical formulation for DoD personnel in accordance with 21 C.F.R. Part 312 (for drugs or biologics) or 21 CFR 812 (for devices) as applicable, to the extent that such use has received any applicable 9119regulatory 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 (Work with Legal): As used herein, diseases caused by INSERT DISEASE OR CONDITION shall collectively be deemed the “XXX.” If the Performer chooses not to develop and/or produce ITEM for the treatment of the XXX, 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 ITEM for the treatment of the XXX, under the terms and conditions set forth in Attachment 5. For the purpose of Attachment 5, “subject technology” means: ITEM drug product for the XXX targeted in the Statement of Work. For clarity, if the Performer chooses to develop and/or produce ITEM for at least one disease that is a XXX, 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.

-OR- If using Options, you would include language like the following:

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.

2. If exercised, the Option 1 research effort will commence upon effective (signature) date of option exercise through the last delivery identified in the Milestone Schedule for the Option 1 research effort.

*You will also need to include these in the CLIN Structure in Section B (PD2), the Statement of Work, and in the Milestone Schedule.

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 significantsubcontractor 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 (work with legal) : As used herein, diseases caused by ENTER NAME of virus shall collectively be deemed the “Specific Virus Diseases.” If the Performer chooses not to develop and/or produce DRUG, BIOLOGIC OR DEVICE for the treatment of the Specific Virus Diseases, 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 DRUG, BIOLOGIC OR DEVICE for the treatment of the Specific Virus Diseases, 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 Agreement.

ARTICLE 4 AGREEMENT ADMINISTRATION

This Agreement will be administered by DHA R&D Contracting. Unless otherwise provided in this Agreement, approvals permitted or required to be made by the Government may be made only by the DHA R&D Contracting 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 Schrieder Street Fort Detrick, MD 21702 Insert Phone Number Insert Email Address

Agreement Specialist (AS):

Insert Name

DHA

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

Agreements Officer’s Representative (AOR):

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

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 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) 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. OPTIONAL (insert if using options or phases) Options.

If necessary, include any factors used for determining whether to exercise the option. You would need to specify any criteria used as part of any down-select decision, when you have more than one performer and will be reducing the competition through the exercise of the option.

This could be a successful test, demonstration, outside approval process, or potentially a milestone.

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

2. 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 XX days before the agreement expires. The preliminary notice does not commit the Government to an extension.

3. The total duration of this Agreement, including the exercise of any options under this article, shall not exceed XX 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 (insert for Cost Reimbursable 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 (insert for Cost Reimbursable 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. OPTIONAL (insert for Cost Reimbursable Agreements) 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 proposal.

4. Final indirect cost rates shall be used for Agreement closeout, unless the AO determines quick-closeout procedures can be used.

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.

Note: These instructions are specific to Contractor Acquired Property. In most cases, CAP should be limited. Be cautious of costs associated with capital facility improvements - like making the performer's facility compliant for GMP or clean rooms. Because of the potential of cost sharing, local procedures are included below for acquired property. If you are providing GFP, you will need to use the DFARS instructions/GFP portion of PIEE. Specifically, you will need to include terms substantially the same as those found at FAR 52.245-1, DFARS 252.245-7005, 252.211-7007. Similar to invoicing, there is no alternative to tracking GFP other than the GFP module in PIEE.

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 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 terms 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 term 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 term until three years after the date the final payment is made by the United States under this Agreement.

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

I. Flow down. The Performer shall include Articles 1, 6,7,8,9,10,11,12,13, suitably modified, to identify all parties, in all subcontracts 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 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 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 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 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 shall the Government be liable for claims for consequential, punitive, special and incidental damages, claims for lost profits, or other indirect charges.

ARTICLE 6 FINANCIAL MATTERS

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 . If cost share is proposed include: 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. If no Cost Share applies, remove this language and tailor to your requirement. For example, for Cost plus fixed fee or Cost Plus percentage of cost, state the amount of cost and the amount of fee or fee percentage.

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. Milestone XYZ is incrementally funded in the amount of $XXXX, including an estimated cost of $XYZ and a fixed fee of $XYZ or including an estimated cost of $XYZ and fee percentage dollars of $XYZ. It is anticipated that additional funds for Milestone XYZ will be provided on or about XYZ.

2. OPTIONAL (if allowing for advanced agreements/pre-award costs on cost type agreement). Pre-Agreement Costs. All costs which have been incurred by the Performer on or after (enter date) and before the effective date of this…