APPENDIX E-Draft OT Agreement.docx

Attachment 4

Agreement No. 1AYSAX00000X

ADVANCED RESEARCH PROJECTS AGENCY FOR HEALTH (ARPA-H)

SAMPLE OTHER TRANSACTION (OT) AGREEMENT

VERSION: AUGUST 2026

NOTES

1. Introduction: This is a sample OT Agreement with Articles and language that may be used in an ARPA-H OT. This version is a fixed-price milestone sample with no resource sharing involved. In some cases, ARPA-H agreements may reflect other approaches and arrangements, including fixed, flexible milestones and/or resource sharing.

2. Text: Any text highlighted in turquoise may be information the Government asks Performers to provide, and text highlighted in yellow is information usually provided by the Government; however, any final language will be determined by the cognizant ARPA-H Agreements Officer (AO) and agreed upon by both Performer and AO[footnoteRef:2]. Text in red is an instruction or note to the AO. Font is Avenir Next LT Pro Light, size11. [2: NOTE FOR AO: Articles and Table of Contents (TOC): This sample includes an area for Special Articles but does not include actual content. Depending on the uniqueness of the Program/Project and Agreement, the TOC should reflect the actual articles and attachments associated with the final Agreement between the Government and the Performer. To update the TOC, ensure that Track Changes is off. Then click on References. Click on Update Table (to the left) and, for the first iteration, update the entire table. This will ensure that deletions are captured in the TOC. For all successive updates, click on Update Page Numbers Only. To add an article or attachment to the TOC, highlight the title of the element being added, go to Styles in the Home tab, and click on Heading 1 Articles. This will capture the title for the TOC. Then update the TOC (Update Entire Table).]

OTHER TRANSACTION AGREEMENT

BETWEEN

INSERT PERFORMER NAME, ADDRESS, AND UNIQUE ENTITY IDENTIFIED (UEI)

AND

THE ADVANCED RESEARCH PROJECTS AGENCY FOR HEALTH (ARPA-H)

CONCERNING

INSERT PROGRAM/PROJECT TITLE

Agreement No.: AY2AX000XXX Authority: 42 United States Code (U.S.C.) § 290c(g)(1)(D)

Date of the Agreement: MM/DD/YYYY

This Agreement is entered into between the United States (U.S.) Government, represented by The Advanced Research Projects Agency for Health (ARPA-H), and INSERT PERFORMER NAME under U.S. federal law.

FOR INSERT PERFORMER NAME

FOR THE GOVERNMENT

ADVANCED RESEARCH PROJECTS AGENCY FOR HEALTH

TABLE OF CONTENTS

ARTICLE 1: SCOPE OF THE AGREEMENT

A. Background and Scope THIS PARAGRAPH(S) DESCRIBES THE VISION OF THE PROGRAM AND SHOULD ADDRESS THE FOLLOWING:

· THE PURPOSE OF THE AGREEMENT/PROJECT

· THE CURRENT TECHNOLOGICAL SITUATION OR CURRENT STATE OF THE ART

· WHAT MAKES THE PROGRAM/PROJECT A “CRITICAL” EFFORT

· WHY THE CURRENT STATE OF THE ART IS NOT SUFFICIENT (FOR THE US HEALTH CARE MARKET)

· WHAT IS THE PERCEIVED BENEFIT OF HAVING THE GOVERNMENT AS A PARTNER IN THIS PROGRAM AND/OR PROJECT? ADDRESSING THE ISSUES OF PARTICULAR IMPORTANCE TO BOTH INDUSTRY AND ARPA-H

· WHAT THE MARKET POTENTIAL IS IF SUCCESSFUL

· WHAT THE PROJECT TRANSITION GOALS ARE FOR ARPA-H, AND WHAT THE COMMERCIALIZATION GOALS ARE FOR THE PERFORMER

· WHAT WILL WE HAVE ACCOMPLISHED IF THIS PROJECT IS SUCCESSFUL

[APPROXIMATELY ONE PAGE SHOULD BE SUFFICIENT TO DISSCUSS/ADDRESS THE ABOVE TOPICS. A FEW SENTENCES SHOULD SUFFICE TO ADDRESS EACH BULLET. PRESENT IN INTEGRATED/CONCISE NARRATIVE FORMAT]

B. Definitions (Suggested terms/definitions are listed here, but this section should be tailored as needed. If a term is not in the Agreement, it does not need to be in this section.)

In this Agreement, the following definitions apply:

Agreement: The body of this Agreement and Attachments 1 – 4, which are expressly incorporated in and made a part of the Agreement.

Agreements Officer (AO): The person with the authority to enter into, administer, modify, and/or terminate the Agreement and to make relevant determinations. The AO is the Government’s principal point of contact for all contractual, administrative, and financial issues arising under the Agreement, and is the only individual within the Government authorized to redirect the effort in any way.

Agreements Officer’s Representative (AOR): The Government’s technical representative charged with overall responsibility for review and verification of completion of Payable Milestones and the Task Description Document (TDD), including amendments or modifications thereto, as set forth herein. The AOR is not otherwise authorized to make any representations or commitments of any kind on behalf of the Agreements Officer or the Government. The AOR does not have the authority to alter the Performer’s obligations or to change the terms of the Agreement.

Background Intellectual Property: Intellectual Property (IP) that is developed, generated, conceived, or first actually reduced to practice prior to performance of this Agreement.

Covered Government Support Contractor: A contractor under a contract, the primary purpose of which is to furnish independent and impartial advice or technical assistance directly to the Government in support of the Government’s management and oversight of a program or effort. Such contractors may receive access to internal Government and performer data during the performance of a Government contract.

Data: Recorded information, regardless of form or method of recording, which includes, but is not limited to, copyrightable material; unpatentable computer software, including programs, code, documentation and databases; trademarks; and maskworks. The term does not include financial, administrative, cost, pricing, or management information and does not include Subject Inventions, as defined in this Article.

Day: Calendar day(s) unless otherwise specified.

Effective Date: The date of the last signature on the Agreement.

Foreign Entity: A firm or institution organized or existing under the laws of a country other than the U.S., 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 U.S. Government, as represented by ARPA-H.

Government Purpose: Any activity in which the U.S. Government is a party, including cooperative agreements with international or multi-national organizations or sales or transfers by the U.S. Government to foreign governments or international organizations. Government purposes include competitive procurement, but do not include the Rights to use, modify, reproduce, release, perform, display, or disclose Data for commercial purposes or authorize others to do so.

Government Purpose Rights: The right to use, modify, reproduce, perform, display, release, or disclose, in whole or in part and in any manner, for Government purposes only, and to have or permit others to do so for Government purposes only.

Intellectual Property: Intangible creations of the human mind, such as inventions; literary and artistic works; designs; and symbols, names and images used in commerce. Such creations may be protected by law through methods such as patents, copyrights, trademarks, or trade secrets. IP includes Background and Foreground IP. Background IP is developed, generated, conceived, or first actually reduced to practice prior to performance of this Agreement. Foreground IP is developed, generated, conceived, or first reduced to practice in performance of this Agreement.

Invention: Any invention or discovery which is or may be patentable or otherwise protectable under Title 35 of the U.S.C.

Limited Rights: The right to use, modify, reproduce, release, perform, display, or disclose, in whole or in part, within the Government. These rights do not include, without the written permission of the Performer, release or disclose outside the Government, use for manufacture, or authorize use by another party, except for Government support contractors acting within the scope of their government support contract.

Made: When used in relation to any invention means the conception or first actual reduction to practice of such invention.

Party: The Government (represented by ARPA-H), the Performer, or both.

Performer: COMPANY/ORGANIZATION/TEAM NAME

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, 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.

Project: The research and development being conducted by the Performer under this Agreement.

Property: Any tangible personal property other than property consumed during the execution of work under this Agreement.

Senior or Key Personnel: Individuals, in addition to the Principal Investigator or Program/Project Director, who contribute to the scientific development or execution of a project in a substantive, measurable way, regardless of whether they receive salaries or compensation directly under this Agreement. It is typical that each team member entity expected to perform critical work, as stipulated in the TDD, has at least one senior or key person. This includes, but is not limited to, all individuals whose absence would have a significant impact on the scope of the Project as stipulated in the TDD. These individuals are approved by the Government to perform work under this Agreement.

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

Sub-performer: Any person or entity awarded by the Performer part of the work or services under this Agreement. In this Agreement, the term sub-performer includes sub-awardees, subcontractors, and other team members.

Team Member Entities: The Performer and sub-performers. It also includes contractors and vendors that will supply components, information, research data, or material that is critical to the scope of the project as stipulated in the TDD.

Task Description Document (TDD): A document that outlines the proposed technical solution and may include details of technical tasks to be performed.

Unlimited Rights: The right to use, modify, reproduce, perform, display, release, or disclose, in whole or in part, in any manner and for any purposes whatsoever, and to have or permit others to do so as well.

C. Scope of the Project

1. The purpose of this Agreement is to advance research and technology goals of the [PROGRAM NAME] Program. The Performer shall be responsible for the work described in the TDD, incorporated in this Agreement as Attachment 1, and shall submit all deliverables as required by Attachment 2 and Attachment 3.

2. The Performer shall be paid a fixed amount for each milestone accomplished in accordance with the Schedule of Milestones and Payments stated in Attachment 3. The Parties may revise the Schedule of Milestones and Payments in accordance with Article 3.

ARTICLE 2: TERM

A. Term of this Agreement The term of the Agreement begins on the Effective Date of the Agreement and continues for INSERT # OF MONTHS. Provisions of this Agreement, which, by their express terms or by necessary implication, apply for periods beyond the term of the Agreement.

B. Termination Provisions

1. The Government may terminate this Agreement by written notice to the Performer. Additionally, the Performer may request a termination of the Agreement by submitting a request to the Government in writing. If the Performer requests termination of this Agreement, the Government may, at its discretion, agree to terminate.

2. In the event of a termination, the Government and the Performer should negotiate in good faith a reasonable and timely adjustment of all outstanding issues between the Parties. The Government will have rights in Intellectual Property as described in Article 7. Failure of the Parties to agree to terminate or reach an agreement on any outstanding issues related to termination shall follow the resolution procedures in Article 6.

C. Extending the Agreement The Parties may extend by mutual written agreement the term of this Agreement if funding availability and research opportunities reasonably warrant. Any extension shall be formalized through modification of the Agreement by the Agreements Officer (AO) and the Performer’s Administrator.

ARTICLE 3: MANAGEMENT OF THE PROJECT

A. Management and Project Structure

1. The Performer shall be responsible for the overall technical planning and performance, management, and execution of the Project. The Performer shall submit a Project Plan Document in accordance with Attachment 2 and participate in the Project kickoff meeting and regularly scheduled project review and milestone activities in accordance with Attachment 1.

2. The ARPA-H Program Manager (PM) shall be responsible for the monitoring of the progression of the Project, oversight, and acceptance of completed payable milestones and deliverables. The AOR may assist the AO and PM in performing these functions and in general administration of Agreement terms.

B. Modifications

1. The Parties may modify the Agreement by mutual agreement. Recommendations by the Performer for modifications, including justifications to support any changes to the TDD and prospective milestones, will be documented and submitted to the Government points of contact. This documentation must detail the technical, chronological, and financial impact of the proposed modification to the Project.

2. The ARPA-H PM, with assistance from the AOR as needed, will review and verify any recommendations to revise or otherwise modify Attachment 1, Attachment 3, or other proposed changes to the Agreement terms and conditions.

3. The Government may execute minor or administrative Agreement modifications unilaterally. Minor or administrative changes are those that do not affect the substantive rights of the parties and include, but are not limited to, incremental funding, changes in the paying office or appropriation data, or changes to update Government or Performer personnel identified in the Agreement (e.g. incremental funding, changes in the paying office or appropriation data, changes to Government or the Performer’s personnel identified in the Agreement, etc.) unilaterally, with no signature from the Performer.

4. The AO will execute all modifications to the Agreement. The Government is not required to pay for additional or revised milestones until the Agreement has been amended to effectuate the modification.

C. Records The Performer shall maintain, and make available for Government inspection, records related to its performance under this Agreement for a period not to exceed three (3) years after expiration of the term of the Agreement.

ARTICLE 4: AGREEMENT POINTS OF CONTACT

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):

[INSERT NAME]

[INSERT ORGANIZATIN/OFFICE]

[INSERT PHONE NUMBER]

[INSERT EMAIL ADDRESS]

ARPA-H Program Manager (PM):

[INSERT NAME]

[INSERT ORGANIZATION/OFFICE]

[INSERT PHONE NUMBER]

[INSERT EMAIL ADDRESS]

Agreements Officer’s Representative (AOR):

[INSERT NAME]

[INSERT ORGANIZATION/OFFICE]

[INSERT PHONE NUMBER]

[INSERT EMAIL ADDRESS]

B. Performer Points of Contact

Performer’s Administrative/Contracting:

[INSERT NAME]

[INSERT ORGANIZATION/OFFICE]

[INSERT PHONE NUMBER]

[INSERT EMAIL ADDRESS]

Performer’s Project Manager/Principal Investigator:

[INSERT NAME]

[INSERT ORGANIZATION/OFFICE]

[INSERT PHONE NUMBER]

[INSERT EMAIL ADDRESS]

ARTICLE 5: OBLIGATION AND PAYMENT

A. Obligation The Government’s liability to make payments to the Performer is limited to only those funds obligated under this Agreement. The amount of funds obligated to this Agreement will be recorded on the signatory page of the Agreement and updated as funds are added by the Government.

B. Payments

1. The Government shall make fixed payments to the Performer for the completion of milestones.

2. To enable payment, the Performer shall:

a. Maintain an active registration for ‘All Awards’ in System for Award Management (SAM) throughout the life of the award,

b. Ensure an Electronic Business Point of Contact is designated in SAM at http://www.sam.gov, and

c. Register to use the Payment Management System (PMS) within ten (10) days after award of this Agreement.

PMS guidance can be found here: https://pms.psc.gov/training/grant-recipient-training.html. The Performer is required to utilize PMS system when submitting invoices under this Agreement. PMS is a centralized payment and cash management system. Payments are made by PMS, operated by the Program Support Center, in accordance with Department of the Treasury and Office of Management and Budget requirements.

PMS Information:

· Payment System Identifier: [Enter Performer’s Employer Identification Number (EIN) as formatted in eRA including the prefix (e.g. 1 and suffix (e.g. A1)].

· Document Number: AAX000XXXX [Enter Number from on “Manage” screen within eRA]

3. Payee Information: As identified in SAM.

· CAGE Code: Enter CAGE

· UEI: Enter UEI

4. The Performer shall document the accomplishments of each milestone by submitting milestone reports for review and approval as required per Attachment 2.

5. The ARPA-H PM, with the assistance of the AOR as needed, will be responsible for reviewing all deliverable(s)/ milestone report(s) to confirm whether the milestone has been met. Within fourteen (14) days of submission, the PM or AOR will either provide written notice of rejection to the Performer, which includes feedback regarding deficiencies requiring correction; or provide a written notice of acceptance to the Performer and AO. If the Government rejects a milestone report, the Government shall afford the Performer with reasonable opportunities to cure or resubmit the milestone report. Written Government confirmation that the milestone has been met will ultimately be required before the payment request is paid, per Subsection 7 below.

6. Upon written verification of the accomplishment of the milestone by the AOR or PM, the Performer may request payment through PMS. The payment request must include a justification (limited to 1,000 characters) such as:

“The payment is justified upon completion of [Milestone(s) (or TDD tasks/references [XX]), as accepted by the Program Manager on [date], for the [XX] program/project statement.”

The justification must not include any personally identifiable information. If additional information is needed, or a correction is needed, a request for clarification will be sent back to the Performer in the Defend the Spend (DTS) System so a revised justification can be submitted.

7. Once the payment request is approved in PMS, it will interface with the DTS System for final Government approval before flowing back to PMS to process the payment.

8. The Performer will receive payment via PMS for amounts set forth in Attachment 3.

ARTICLE 6: DISPUTES

A. General The Parties shall communicate with one another in good faith and in a timely and cooperative manner when raising issues under this Article, with the objective of resolving disputes by mutual agreement.

B. Dispute Resolution Procedures

1. Any dispute between the Government and the Performer concerning questions of fact or law arising from or in connection with this Agreement and, regardless of whether involving an alleged breach of this Agreement, may be raised only under this Article. This Article describes the applicable administrative review process that must be completed by the parties before any other dispute resolution process or legal action pertaining to the terms of this Agreement may be taken. Completion of this process forecloses any further administrative review.

2. Whenever disputes 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 notification made under Article 6.B.3, constitute the basis for relief under this Article unless the ARPA-H Director waives this requirement.

3. Failing resolution by mutual agreement, the aggrieved Party shall document the dispute by notifying the other Party (through the ARPA-H AO or the Performer’s Administrative point of contact, as the case may be) in writing of the relevant facts, unresolved issues, and clarification or remedy sought. Within seven (7) days after providing notice to the other Party, the aggrieved Party may, in writing, request a joint decision by ARPA-H’s Head of Contracting Activity (HCA), and a senior executive no lower than [INSERT A LEVEL OF EXECUTIVE FAR ENOUGH REMOVED FROM THE PROGRAM TO MAINTAIN A GREATER LEVEL OF IMPARTIALITY] level appointed by the Performer. The other Party shall submit a written position on the matter(s) in dispute within thirty (30) days after being notified that a decision has been requested. ARPA-H’s HCA and the senior executive shall conduct a review of the matter(s) in dispute and render a decision in writing within thirty (30) days of receipt of such written position.

4. Failing satisfactory resolution from the joint decision, the Performer may, in writing, request a final review from the ARPA-H Deputy Director. The ARPA-H Deputy Director may elect to conduct this review jointly with a senior executive no lower than [INSERT A LEVEL OF EXECUTIVE FAR ENOUGH REMOVED FROM THE PROGRAM AND ABOVE THE PERSON IDENTIFIED AT SUBPARAGRAPH 3 TO MAINTAIN A GREATER LEVEL OF IMPARTIALITY] level appointed by the Performer. Following the review, the ARPA-H Deputy Director will reach a decision and notify the Parties in writing within sixty (60) days of the Performer’s written request. To the extent permitted by law, such resolution shall be final and binding, except that if not satisfied with the results of completing the administrative review process, either party may pursue any right and remedy in a court of competent jurisdiction.

C. 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 ARPA-H funding disbursed as of the time the dispute arises. In no event shall ARPA-H be liable for claims for consequential, punitive, special, and incidental damages, claims for lost profits, or other indirect damages.

ARTICLE 7: INTELLECTUAL PROPERTY RIGHTS

A. Patent Rights

1. Allocation of Principal Rights – Performer

a. Unless the Performer notifies the Government that the Performer does not intend to retain title, the Performer shall retain the entire right, title, and interest throughout the world to each Subject Invention consistent with the provisions of this Article.

b. For each Subject Invention to which the Government obtains title, the Performer shall retain a nonexclusive, royalty-free license throughout the world to said Subject Invention. This license extends to the Performer’s domestic subsidiaries and affiliates, including Canada, if any, and includes the right to grant license of the same scope to the extent that the Performer was legally obligated to do so at the time the Agreement was awarded. The license is transferable only with the approval of the ARPA-H AO, except when transferred to the successor of that part of the business to which the Subject Invention pertains. ARPA-H approval for license transfer shall not be unreasonably withheld.

2. Allocation of Principal Rights – ARPA-H

a. With respect to any Subject Invention in which the Performer retains title, ARPA-H shall retain a nonexclusive, nontransferable, irrevocable, paid-up Government Purpose license in the Subject Invention throughout the world, regardless of the protection method chosen.

b. Upon ARPA-H’s written request, the Performer shall convey title to any Subject Invention to ARPA-H under the following conditions. ARPA-H may only request title within sixty (60) days after learning of the Performer’s actions.

1) The Performer fails to disclose a Subject Invention prior to the completion of the Agreement, or

2) The Performer elects not to retain title to a Subject Invention.

c. Regarding Article 7.A.2.b.1, ARPA-H shall not make any such request in an arbitrary or capricious manner and/or not in abuse of its discretion, and all such requests shall be subject to Article 6, Disputes.

3. Invention Disclosure, Election of Title, and Election of Protection Method

a. The Performer shall disclose each Subject Invention to ARPA-H within four (4) months after the inventor discloses it in writing to his company personnel responsible for patent matters. The disclosure shall be made to the ARPA-H AO and shall be in the form of a written report sufficiently complete in technical detail. The report shall identify the Agreement number, the circumstances under which the invention was made, the identity of the inventor, and any publication, sale or public use of the invention.

b. If the Performer determines that it does not intend to retain title to any Subject Invention, the Performer shall notify ARPA-H in writing no more than sixty (60) days prior to the end of the one (1) year statutory U.S. patent protection period.

c. If the Performer chooses to retain title to any Subject Invention, the Performer shall inform the ARPA-H AO of its corporate determination how to best protect any Subject Invention. The Performer shall choose one of the following two options to protect any Subject Invention.

1) Protection of the Subject Invention through the patent process

i. If the Performer chooses to file a patent application in the U.S. or other countries or forums throughout the world, the Performer shall notify ARPA-H of this decision, the dates on which the patent applications were filed and where.

ii. The Performer shall notify ARPA-H of any decisions not to continue the prosecution of a patent application, pay maintenance fees, or defend in a reexamination or opposition proceeding on a patent, in any country, not less than thirty (30) days before the expiration of the response period required by the relevant patent office.

iii. The Performer shall include, within the specification of any U.S. patent application and any patent issued covering a subjection invention, the following statement:

“This invention was made with U.S. Government support under Agreement No. (AY2AX000XXX) awarded by the Advanced Research Projects Agency for Health. The U.S. Government has certain rights in the invention.”

2) Protection of the Subject Invention as a trade secret

i. If the Performer chooses not to patent the Subject Invention but instead protect it as a trade secret, the Performer shall notify the ARPA-H AO of this decision in writing within eight (8) months of the Performer’s disclosure of the invention to ARPA-H. ARPA-H may, at its discretion, approve requests for an extension of time for electing to protect a Subject Invention as a trade secret, and such a request will not be unreasonably withheld. Such requests may be made within or after the eight-month deadline.

ii. In that notification, the Performer shall state the applicable law that will govern protection of the trade secret as well as any special protection methods or actions that the Performer will take to ensure secrecy.

iii. If the Government discloses a Subject Invention which is protected as a trade secret to a third party Covered Government Support Contractor, the Government will ensure trade secrets remain protected under an obligation of confidentiality with respect to such Covered Government Support Contractors. In order to ensure necessary confidentiality is maintained, Performer will negotiate in good faith with the goal of entering into a non-use and-disclosure agreement with that third party at the Government's request to cover information developed under this Agreement that discloses a Subject Invention that is maintained as a trade secret and is to be used by the third party solely for Government purposes. Performer will disclose such information to the third party within fifteen (15) days of entering into a non-use and -disclosure agreement.

4. Administrative Actions

a. At the completion of the Agreement, the Performer shall submit a comprehensive listing of all Subject Inventions disclosed under this Article during the Agreement and the status of each. All required reporting shall be done, to the extent possible, using the iEdison reporting website: https://nist.gov/iedison. To the extent that the reporting cannot be accomplished by use of iEdison, any required documentation will be submitted to the ARPA-H AO.

b. The Performer agrees to execute or have executed and promptly deliver to ARPA-H all instruments necessary to:

1) Establish or confirm the rights the Government has throughout the world in any Subject Invention to which the Performer elects to retain title, and

2) Convey title to ARPA-H when requested under this Article and to enable the Government to obtain patent protection throughout the world in the Subject Invention.

c. The Performer shall instruct and educate its employees of the importance of disclosing inventions promptly to corporate personnel responsible for the administration of patent matters to permit sufficient time to satisfy its notification responsibilities under this Agreement.

5. Exceptional Circumstances

a. The Parties recognize that the Government is making a significant investment in the Subject Inventions under this Agreement. To protect the Government’s interests, the Parties agree to the following in the event the Performer ceases operations, exits the [INSERT DESCRIPTION] industry; or otherwise makes the Subject Inventions commercially unavailable or unavailable to the Government:

1) Upon ARPA-H’s request and an adequate showing of need, the Performer, assignee, or exclusive licensee will provide a non-exclusive license to a responsible applicant or applicants, under terms that are reasonable under the circumstances, and

2) If the Performer, assignee or exclusive licensee refuses a reasonable request from the Government, ARPA-H has the right to grant such a license itself if ARPA-H makes a reasonable determination that such action is necessary to alleviate societal health or safety needs or national security needs, which are not reasonably satisfied, by the Performer, assignee, or exclusive licensees.

B. Data Rights [DATA RIGHTS WILL BE NEGOTIATED BASED ON THE FINAL MILESTONE PLAN AND CAN BE CREATED, DEFINED, AND INCLUDED IN THE AGREEMENT BASED ON THE CIRCUMSTANCES AND THE NEEDS OF THE PARTIES]

1. Allocation of Principal Rights

a. With respect to Data developed, generated or delivered under this Agreement, the Government will and hereby receives Government/Limited/XYZ Rights except as provided in Article 7.B.1.b and 7.B.1.c:

b. For Background IP, the Government will receive the rights specified in the IP table in Attachment X.

c. With respect to the following Data deliverables, the Government shall receive Unlimited Rights (this may be modified by the AO depending on the rights asserted by the Performer and agreed to by the Government):

1. Technical Status Reports

1. Milestone Reports

1. Final Report(s)

d. The Government may require delivery of Data developed or generated under this Agreement within two (2) years after completion or termination of this Agreement. Any request for delivery of data will be made in writing with at least sixty (60) days notice. The Government will reimburse the Performer for reasonably incurred costs for gathering and delivery of the Data.

2. Exceptional Circumstances

a. Notwithstanding any other provision of this Section, in the event the Government chooses to exercise its rights under this Article, the Performer shall deliver, at no additional cost to the Government, all Data necessary to achieve practical application of a specified Subject Invention. The Government will retain Unlimited Rights, as defined in Article 1, to this delivered Data.

b. To facilitate any future requests and deliveries, the Performer agrees to retain and maintain in good condition for three (3) years after completion or termination of this Agreement all Data necessary to achieve practical application of any Subject Invention as defined in Article 1 of this Agreement.

c. The Government is required to execute this exercise of rights in writing and the Performer agrees to deliver the Data within sixty (60) days from the date of the written request. The Performer may request an extension of this time period by making a written justification to the Government and such a request will not be unreasonably withheld.

3. Marking Data

a. The Performer shall mark any Data delivered under this Agreement with the following legends, as applicable:

“GOVERNMENT PURPOSE RIGHTS

Agreement Number: AY2AX000XXX Performer Name: [INSERT PERFORMER NAME]

In accordance with Article 7, as applicable, contained in the above identified Agreement, the Government has the right to: (a) use, modify, reproduce, perform, display, release, or disclose, in whole or in part and in any manner, for Government purposes only, and to have or permit others to do so for Government purposes only. Government purposes includes any activity in which the U.S. Government is a party, including cooperative agreements with international or multi-national organizations or sales or transfers by the U.S. Government to foreign governments or international organizations. Government purposes include competitive procurement, but do not include the rights to use, modify, reproduce, release, perform, display, or disclose Data for commercial purposes or authorize others to do so. Any reproduction of this Data or portions thereof marked with this legend must also reproduce the markings.”

“LIMITED RIGHTS

Agreement Number.: AY2AX000XXX Performer Name: [INSERT PERFORMER NAME]

In accordance with Article 7, as applicable, contained in the above identified Agreement, the Government has the right to use, modify, reproduce, release, perform, display, or disclose, in whole or in part, within the Government. The Government may not, without the written permission of the Performer, release or disclose outside the Government, use for manufacture, or authorize use by another party. The Government may release to a covered Government support contractor in performance of its Government support contract. Any reproduction of this Data or portions thereof marked with this legend must also reproduce the markings.”

b. No marking is necessary if the Performer furnishes Data without restriction.

C. Lower Tier Agreements The Performer shall include this Article, suitably modified, in all subawards or lower tier agreements, for experimental, developmental, or research work.

ARTICLE 8: FOREIGN ACCESS TO INTELLECTUAL PROPERTY

This Article shall remain in effect during the term of the Agreement and for (number of years) years thereafter.

A. Definitions In this Article, the following definition applies:

Fundamental Research: Research in science, engineering, or mathematics, the results of which ordinarily are published and shared broadly within the research community and for which the researchers have not accepted publication restrictions for proprietary or national security reasons.

B. General The Parties agree that Intellectual Property developed and/or generated under this Agreement may constitute a significant enhancement to the security and economic vitality of the U.S. Accordingly, access to important Intellectual Property developments under this Agreement by foreign entities must be carefully controlled. The controls contemplated in this Article are in addition to and are not intended to change or supersede the provisions of the International Traffic in Arms Regulations (ITAR) (22 Code of Federal Regulation (CFR) Parts 120-130) and the Department of Commerce’s (DOC’s) Export Administration Regulations (EAR) (15 CFR Parts 730-774) regarding export-controlled items. The Performer's responsibility to comply with all applicable laws and regulations regarding export-controlled items and the handling of information exists independent of, and is not established or limited by, the information provided by this Article. The Performer shall consult with the Department of State regarding any questions relating to compliance with the ITAR and shall consult with the DOC regarding any questions relating to compliance with the EAR.

C. Restrictions on Sale or Transfer of Intellectual Property to Foreign Entities

1. In return for the financial investment by the Government in the program, and to promote the national security interests of the U.S., the Government reserves the right to be notified and discuss options with the Performer before Performer’s transfer of Intellectual Property developed or generated under this Agreement to a foreign entity. It is not the Government’s intention to unduly restrict the Performer’s ability to promote and sell its products and services in the global market, but instead to protect the Government’s investment and ability to fully utilize its licenses to the Intellectual Property in the future. For purposes of this Article, a transfer includes the sale of the Performer and all its assets, or the sale or licensing of the Intellectual Property developed or generated under this Agreement. A transfer does not include:

· Sales of products or components, and licenses of Intellectual Property related to sales of products or components (e.g., software, documentation) or non-exclusive licenses,

· Transfers to foreign affiliates or subsidiaries of the Performer for purposes related to the performance of this Agreement,

· Permissible access to Intellectual Property to a foreign entity which is an approved source of supply or source of research services under this Agreement, provided that the access is limited to that necessary to allow the entity to perform its agreed upon role under this Agreement,

· Research ARPA-H agrees is Fundamental Research as defined in this agreement; or

· Any circumstances that have been included in an attachment to this Agreement.

2. In addition, to fully facilitate the Government’s investment in the Intellectual Property developed or generated under this Agreement, the Performer agrees to take reasonable steps to license the exclusive right to use or sell the Intellectual Property in the U.S. only to a person or entity that agrees that any product utilizing the Intellectual Property will be manufactured substantially in the U.S. If the Performer has made reasonable but unsuccessful efforts to identify and license to potential licensees to manufacture in the U.S. or if the Performer, after reasonable efforts, has determined that domestic manufacturing is not commercially feasible, the Performer shall notify the Government in writing, submitted to the AO, of its specific determination and request a waiver. The Government may waive this requirement and will not unreasonably deny such a request by the Performer without a specific and detailed written determination. The Government shall not unreasonably delay or withhold such a waiver.

3. The Performer shall provide timely written notice to the Government of any proposed transfer to a foreign entity at least forty-five (45) days prior to the proposed date of transfer. This notice must cite this Article and must state specifically what is to be transferred and the general terms of the transfer, including what is to be transferred and to whom. The Government will respond within thirty (30) days of receipt of the waiver request whether it agrees with the proposed transfer, if it would like to have further discussions about the transfer terms, or if it intends to invoke its rights under this Article. If the Government does not respond within thirty (30) days of the receipt of the waiver request, the Performer may assume that there are no objections to the transfer. If the Government does respond in a manner with which the Performer disagrees, the Performer may utilize the procedures under Article 6, Disputes.

4. If the Government determines that the transfer may have adverse consequences to the furtherance of its investment in the program the interests of the U.S., the Parties agree to jointly discuss the goal of the transfer and discuss alternative options that would obviate or mitigate the potential adverse consequences to the U.S., but which would provide substantially equivalent and acceptable benefits to the Performer.

5. In the event the Performer transfers the Intellectual Property developed or generated under this Agreement without the Government’s written consent -

a. the Performer shall refund to the Government the full amount of federal funds paid under the Agreement for the development of the Intellectual Property, and

b. the Government shall have a non-exclusive, nontransferable, irrevocable, paid-up license to practice or have practiced on behalf of the U.S. the Intellectual Property, regardless of form or protection method, throughout the world for Government purposes. Upon request of the Government, the Performer shall provide written confirmation of such licenses.

D. Lower Tier Agreements The Performer shall include this Article, suitably modified, in all subawards or lower tier agreements, regardless of tier, for experimental, developmental, or research work.

ARTICLE 9: TITLE TO AND DISPOSITION OF TANGIBLE PROPERTY

[This Article may be modified when there is a University Performer at either the Prime or Sub level.]

[Use these paragraphs A and B when no items of property valued at $10,000 or more are expected to be acquired.] A. Title to Property No significant items of tangible property are expected to be acquired under this Agreement. Title to each item of property acquired under this Agreement with an acquisition value less than $10,000 shall vest in the Performer upon acquisition with no further obligation of the Parties unless otherwise determined by the AO. Should any item of property with an acquisition value equal to or greater than $10,000 be required, the Performer shall obtain prior written approval of the AO. Title to this property shall vest in the Performer upon acquisition, but the Government will retain an ownership interest in the property and will participate in the disposition of property at the conclusion of the Agreement. The Performer shall be responsible for the inventory, maintenance, repair, protection, and preservation of all property at its own expense.

B. Disposition of Property At the completion of this Agreement, items of property with an acquisition value equal to or greater than $10,000 may be handled in one of the following approaches:

· 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; or

· Transferred to a Government research facility with title and ownership being transferred to the Government; or

· Donated to a mutually agreed University or technical learning center for research purposes; or

· Any other Government-approved disposition approach.

[Use these paragraphs A and B when property valued at $10,000 or more will be acquired.] A. Title to Property Items of property with an acquisition value of $10,000 or more are expected to be acquired under this Agreement. Title to each item of property acquired under this Agreement with an acquisition value less than $10,000 shall vest in the Performer upon acquisition with no further obligation of the Parties unless otherwise determined by the AO. Additional items of property with an acquisition value of $10,000 or more can only be obtained with prior written approval of the AO and modification of this Agreement. Title to this property shall also vest in the Performer upon acquisition, but the Government will retain an ownership interest in the property and will participate in the disposition of property at the conclusion of the Agreement. The Performer shall be responsible for the inventory, maintenance, repair, protection, and preservation of all property at its own expense.

B. Disposition of Property At the completion of the term of this Agreement, items of property with an acquisition value at or greater than $10,000 shall be handled in the following approaches:

· 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; or

· Transferred to a Government research facility with title and ownership being transferred to the Government; or

· Donated to a mutually agreed University or technical learning center for research purposes; or

· Any other Government-approved disposition approach.

ARTICLE 10: PUBLIC RELEASE OR DISSEMINATION OF INFORMATION

A. Scientific Publications

1. The Performer shall provide notice and a draft of scientific publications to the ARPA-H Program Manager at least ten (10) days prior to any scientific publication relating to the research being conducted in the performance of the Agreement. Publications include scientific manuscripts, public presentations of research, and submissions to open-source repositories.

2. The Government may suggest revisions to the relevant draft scientific publication. The Performer shall consider the Government’s suggested revisions and related concerns. The Performer shall coordinate a meeting to discuss any outstanding suggested revisions or related concerns prior to submission or dissemination of the scientific publication. If the Government is given the opportunity to examine the relevant draft scientific publication, the Government cannot prevent publication of the scientific publication, and the Performer may publish the scientific publication.

4. Scientific publications do not include:

a. Unclassified information or documents used in the patent process, copyright approval process, or trademark approval process, or

b. Papers or presentations prepared in response to academic requirements that are not intended for public release outside the academic institution.

B. Press and Public Materials

1. The Performer shall provide notice and draft press and public materials to releases@arpa-h.gov at least (10) days prior to any public release relating to the research being conducted in performance of the Agreement. Press and public materials include press releases, media advisories, and advertisements.

2. Press and public materials do not include:

a. Social media posts, email newsletters, or blogs

b. Sub-performer press and public materials

c. Academic papers, presentations, and submissions to open-source repositories subject to Article 10.A.

C. ARPA-H Logo

The Performer shall adhere to the ARPA-H logo guidance located at: https://arpa-h.gov/logo.

D. Lower Tier Agreements The Performer shall include this Article, suitably modified, in all subawards or lower tier agreements.

ARTICLE 11: CIVIL RIGHTS

By accepting this award, the Performer certifies that it is compliant with applicable anti-discrimination laws and will remain compliant for the duration of the Agreement. These laws include, but are not limited to, Title VI of the Civil Rights Act of 1964 as amended (42 U.S.C. § 2000d et seq) and Title IX of the Education Amendments of 1972, as amended, (20 U.S.C. §§ 1681 et seq). The Performer shall have a signed Assurance of Compliance (HHS Form 690) on file with HHS Office for Civil Rights throughout the term of this Agreement.

ARTICLE 12: SECURITY

The Performer shall make all necessary efforts to secure and defend the systems and Data associated with the research supporting ARPA-H, to include meeting any applicable federal cybersecurity requirements and informing the Government of any cybersecurity incidents related to the supporting system(s).