ARPA-H MODEL OTHER TRANSACTION.pdf

Agreement No. 1AYSAX00000X

Updated 3/14/2024

OTHER TRANSACTION AGREEMENT

BETWEEN

POTENTIAL PERFORMER

AND

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

CONCERNING

PROPOSE EFFORT

Agreement No.: 1AYSAX00000X

Total Amount of the Agreement: $ X,XXX,XXX [Base + Exercised Options] Base: $ X,XXX,XXX Option 1: $ X,XXX,XXX Option 2: $ X,XXX,XXX

Authority: 42 U.S.C. 290(c)(g)(1)(D)

This Agreement is entered into between the United States of America, hereinafter called the Government, represented by The Advanced Research Projects Agency for Health (ARPA-H), and POTENTIAL PERFORMER. pursuant to and under United States Federal law.

FOR THE GOVERNMENT

ADVANCED RESEARCH PROJECTS AGENCY

FOR HEALTH

X

X

(Name, Title) (Jennifer M. Mack, Agreement Officer)

TABLE OF CONTENTS

FOR POTENTIAL PERFORMER

ARTICLES

ARTICLE 1 Scope of the Agreement ARTICLE 2 Term ARTICLE 3 Management of the Project ARTICLE 4 Agreement Administration ARTICLE 5 Obligation and Payment ARTICLE 6 Disputes ARTICLE 7 Intellectual Property Rights ARTICLE 8 Foreign Access to Technology ARTICLE 9 Title to and Disposition of Property ARTICLE 10 Public Release or Dissemination of Information ARTICLE 11 Civil Rights Act ARTICLE 12 Security ARTICLE 13 Key Personnel ARTICLE 14 Execution ARTICLE 15 Force Majeure ARTICLE 16 Survival ARTICLE 17 Prohibition on Certain Telecommunications and Video Surveillance Services or

Equipment ARTICLE 18 Government Furnished Property ARTICLE 19 Special Terms and Conditions ARTICLE 20 (OPTIONAL) Human Subjects Research (HSR) ARTICLE 21 (OPTIONAL) Animal Subjects Research (ASR) ARTICLE 22 (OPTIONAL) Associate Contractor Agreement (ACA)

ATTACHMENTS

ATTACHMENT 1 Task Description Document (TDD) ATTACHMENT 2 Report Requirements ATTACHMENT 3 Schedule of Milestones and Payments ATTACHMENT 4 (OPTIONAL) Agreements Officer’s Representative Appointment Memo ATTACHMENT 5 (OPTIONAL) Property/Equipment

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ARTICLE 1: SCOPE OF THE AGREEMENT

A. Background

THIS PARAGRAPH(S) DESCRIBES THE VISION OF THE PROGRAM AND SHOULD ADDRESS THE

FOLLOWING:

• THE PURPOSE OF THE AGREEMENT/PROJECT

• THE CURRENT TECHNOLOGICAL SITUATION (CURRENT STATE OF THE ART)

• WHAT MAKES THE PROGRAM/PROJECT A “CRITICAL TECHNOLOGY” EFFORT

• WHY THE CURRENT TECHNOLOGY 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 TECHNOLOGY TRANSITION GOALS ARE FOR ARPA-H, AND WHAT THE

COMMERCIALIZATION GOALS ARE FOR THE PERFORMER

• WHAT WILL WE HAVE ACCOMPLISHED IF THIS COLLABORATION IS SUCCESSFUL

[APPROXIMATELY 1 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

In this Agreement, the following definitions apply:

Agreement: The body of this Agreement and Attachments 1 – 5, which are expressly incorporated in and made a part of the Agreement.

Agreements Officer (AO): The Government’s principle point of contact for all contractual, administrative and financial issues arising under the Agreement. Notwithstanding any other provision of this Agreement, the Agreements Officer is the only individual within the Government authorized to redirect the effort or in any way amend or modify any of the terms of this Agreement. Legal notices, including notices of disputes, proposed technology transfers under Article 7, invention disclosures, patent and patent application notices, and any notices relating to any allegation or claim relating to intellectual property infringement shall be referred to the Agreements Officer.

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 Technical Description Document, including amendments or modifications thereto, as set forth herein. The Agreements Officer’s Representative 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 specifications of the Agreement.

Covered Foreign Country: The People’s Republic of China.

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.

Covered telecommunications equipment or services:

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

(2) Video surveillance and telecommunications equipment produced by Hytera Communications Corporation, Hangzhou Hikvision Digital Technology Company, or Dahua Technology Company (or any subsidiary or affiliate of such entities);

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

or

(4) Telecommunications or video surveillance equipment or services produced or provided by an entity that the Secretary of Defense, in consultation with the Director of the National Intelligence or the Director of the Federal Bureau of Investigation, reasonably believes to be an entity owned or controlled by, or otherwise connected to, the government of a Covered Foreign Country.

Critical technology:

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

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

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.

Effective Date: The date of the last signature hereon.

Foreign Firm or Institution: A firm or institution organized or existing under the laws of a country other than the United States, its territories, or possessions. The term includes, for purposes of this Agreement, any agency or instrumentality of a foreign government; and firms, institutions or business organizations which are owned or substantially controlled by foreign governments, firms, institutions, or individuals.

Government: The United States of America, as represented by ARPA-H.

Government Purpose: Any activity in which the United States Government is a party, including cooperative agreements with international or multi-national organizations or sales or transfers by the United States 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.

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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.

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

Intellectual Property: The 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 in the law as patents, copyrights, trademarks, or trade secrets.”

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.

Limited Rights: 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 Performer agrees that the Government may release or disclose to a covered Government support contractor in performance of its covered Government support contract.

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

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

Performer: POTENTIAL PERFORMER

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(A).

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 which is the (PROTOTYPE NAME).

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

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, maskworks and copyrights developed under this Agreement.

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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

1. This Agreement is an “other transaction” pursuant to 42 U.S.C. 290(c)(g)(1)(D). The principal purpose of this Agreement is to perform a coordinated research and development program (“Program”) designed to develop BLANK. This research shall be carried out in accordance with Attachment 1, Task Description Document (TDD). The Performer shall submit or otherwise provide all documentation required by Attachment 2, Report Requirements.

2. The Performer shall be paid a fixed amount for each milestone accomplished in accordance with the Schedule of Milestones and Payments set forth in Attachment 3 and the procedures of Article 5.

D. Goals / Objectives

1. The goal(s) of this Agreement are outlined in Attachment 1 and Attachment 3.

2. The Government will have continuous involvement with the Performer. The Government will obtain access to Program results and rights in patents and data pursuant to Articles 7. ARPA-H and the Performer are bound to each other by a duty of good faith in achieving the Program objectives.

ARTICLE 2: TERM

A. Term of this Agreement

The Program commences upon the Execution Date and continues for thirty-six (36) months. Provisions of this Agreement, which, by their express terms or by necessary implication, apply for periods of time other than specified herein, shall be given effect, notwithstanding this Article.

B. Termination Provisions

Subject to a reasonable determination that the program will not produce beneficial results, either Party may terminate this Agreement by written notice to the other Party, provided that such written notice is preceded by consultation between the Parties. In the event of a termination of the Agreement, it is agreed that disposition of Data developed under this Agreement, shall be in accordance with the provisions set forth in Article 7. The Government and the Performer will negotiate in good faith a reasonable and timely adjustment of all outstanding issues between the Parties as a result of termination. Failure of the Parties to agree to a reasonable adjustment will be resolved pursuant to Article 6. The Government has no obligation to pay the Performer beyond the last completed and paid milestone if the Performer decides to terminate. Should the Government terminate the Agreement for reasons other than breach of the Agreement by the Performer, the Performer shall be entitled to a pro-rata payment for partial completion of a funded milestone as determined by a good faith assessment of such partially completed milestone which shall be formalized through modification of the Agreement per Article 3.

C. Extending the Term

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 Administrator.

(i) The term of this Agreement may be extended prior to the end of each phase per Attachment 3;

provided that the Government gives the Performer a preliminary written notice of its intent to extend at least thirty (30) days before the Agreement expires. The preliminary notice does not commit the Government to an extension.

(ii) If this option is exercised, the extended Agreement shall be considered to include this Article.

(iii) The total duration of this Agreement, including the exercise of any options under this Article, shall not exceed the total Agreement term set forth in Attachment 3.

ARTICLE 3: MANAGEMENT OF THE PROJECT

A. Management and Program Structure

The Performer shall be responsible for the overall technical and program management, technical planning and execution of the Program. The Agreements Officer’s Representative (“AOR”), in consultation with the ARPA-H Program Manager (“PM”), shall provide recommendations to Program developments and technical collaboration and be responsible for the review and verification of the completed milestone

B. Program Management Planning Process

Program planning will consist of a Program Plan with inputs and reviews from the Performer and ARPA-H management, containing a detailed schedule of research activities and milestones.

The Performer, with ARPA-H PM participation and review, will prepare an overall Program Plan for the active phase that will be delivered to the Government within 10 business days prior to the kickoff meeting. The Program Plan may be presented and reviewed initially at the kickoff meeting, and subsequent program review meetings, at the discretion of the ARPA-H PM.

The Program Plan provides a detailed schedule of research activities, commits the Performer to meet specific performance objectives and describes the program/technical milestones. The Program Plan will consolidate all prior adjustments in the research schedule, including revisions/modifications to prospective milestones. Recommendations for changes and technical revisions or modifications to the Agreement which result from the kickoff meeting or subsequent program review meetings, shall be made in accordance with the provisions of Article 3, Section C.

C. Modifications

1. As a result of meetings, annual reviews, or at any time during the term of the Agreement, research progress or results may indicate that a change in the TDD would be beneficial to project objectives. Recommendations for modifications, including justifications to support any changes to the TDD and prospective milestones, will be documented and submitted by the Performer to the ARPA-H PM and AOR with a copy to the AO. This documentation will detail the technical, chronological, and financial impact of the proposed modification to the research project. The Government is not obligated to pay for additional or revised future milestones until Attachment 3 to this Agreement is formally amended via bilateral modification.

2. The ARPA-H AOR/PM shall be responsible for the review and verification of any recommendations to modify the TDD, prospective milestones, or other proposed changes to the terms and conditions of this Agreement.

3. For minor or administrative Agreement modifications (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.) no signature is required by the Performer.

4. The Government will be responsible for effecting all modifications to this Agreement.

ARTICLE 4: AGREEMENT ADMINISTRATION

Unless otherwise provided in this Agreement, approvals permitted or required to be made by ARPA-H may be made only by the ARPA-H 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):

NAME

Org: ARPA-H; Business Innovation Division Email:

ARPA-H Program Manager (PM):

NAME

Org: ARPA-H; BLANK Office Email:

Agreements Officer’s Representative (AOR):

NAME

Org: ARPA-H; BLANK Office Email:

B. Performer Points of Contact

Performer’s Administrative/Contracting:

[INSERT NAME]

[INSERT ORGANIZATIN/OFFICE]

[INSERT PHONE NUMBER]

[INSERT EMAIL ADDRESS]

Performer’s Program Investigator (PI):

[INSERT NAME]

[INSERT ORGANIZATIN/OFFICE]

[INSERT PHONE NUMBER]

[INSERT EMAIL ADDRESS]

ARTICLE 5: OBLIGATION AND PAYMENT

The Government’s liability to make payments to the Performer is limited to only those funds obligated under this Agreement or by modification to the Agreement. This Agreement may be subject to BLANK funding, as indicated in Attachment 3, which is presently made available for performance under

B. Payments

1. The Parties agree that fixed payments will be made for the completion of milestones.

These payments reflect value received by the Government toward the accomplishment of the research goals of this Agreement.

2. The Performer shall document the accomplishments of each milestone by submitting or otherwise providing the Milestone Reports required by Attachment 2. After written verification of the accomplishment of the milestone by the AOR, the Performer will submit their invoice to the AO for payment approval through the Payment Management Services (PMS), as detailed in Article 5(B)(3).

3. The Performer is required to utilize the PMS when processing invoices under this Agreement. PMS is a centralized payment and cash management system. Payments are made by PMS, operated by PSC, in accordance with Department of the Treasury and OMB requirements.

The Performer shall (i) maintain an active registration for ‘All Awards’ in System for Award Management (SAM) throughout the life of the award, (ii) ensure an Electronic Business Point of Contact is designated in System for Award Management at http://www.sam.gov, and (iii) register to use PMS, within ten (10) calendar days after award of this Agreement. PMS guidance can be found here:

https://pms.psc.gov/training/grant-recipient-training.html .

The following guidance is provided for invoicing processed under this Agreement:

• The AOR identified in Article 4, "Agreement Administration" shall continue to formally inspect and accept the deliverables/ milestones. The AOR shall review the deliverable(s)/ milestone report(s) within fourteen (14) calendar days after submission of the applicable report and either: 1) provide a written notice of rejection to the Performer which includes feedback regarding deficiencies requiring correction, or 2) written notice of acceptance to the Performer, ARPA-H PM and AO. The basis for rejection of a payable milestone shall be that such payable milestone, the accomplishment of which is captured in the associated Payable Milestone Report, fails to meet the acceptance criteria stipulated in Attachment 3 of the agreement. If the Government objects to the acceptance of a Payable Milestone (to include one or more of the deliverables thereunder), the Government will work with Performer so that the Performer has reasonable opportunities to cure/redeliver the associated Payable Milestone/Report. After written verification of the accomplishment by the AOR, the Performer will receive payment via PMS for amounts set forth in Attachment 3.

a. Payee Information: As identified at the System for Award Management.

• Cage Code: BLANK

• UEI: BLANK

4. Limitation of Funds: In no case shall the Government’s financial liability exceed the amount obligated under this Agreement.

C. Financial Records and Reports http://www.sam.gov/ https://pms.psc.gov/training/grant-recipient-training.html

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Upon completion or termination of this Agreement, whichever occurs earlier, the Performer shall furnish a copy of the Final Report required by Attachment 2. As indicated in Attachment 2, no financial reporting is required.

D. Records Retention and Government Access

The Comptroller General of the United States, or any of their duly authorized representatives, have the right of timely and unrestricted access to any books, documents, papers, or other records of the Performer that are pertinent solely to the Performer’s technical performance under this Agreement, in order to make examinations, excerpts, transcripts and copies of such documents. This right also includes timely and reasonable access to the Performer’s personnel for the purpose of interview and discussion related to such records. Such access shall be performed during business hours on business days upon written notice and shall be subject to the security requirements of the audited party to the extent such security requirements do not conflict with the rights of access otherwise granted by this paragraph. The rights of access in this paragraph shall last as long as records are retained. The rights of access in this paragraph do not extend to the Performer’s financial records.

[This subparagraph will be deleted/marked “Reserved” during negotiations if the proposer confirms in writing to the Agreements Officer that it does not currently provide the Government access to records per the terms and conditions of another contractual instrument.]

E. Audits and Accounting System Compliance

This is a fixed-support Other Transaction utilizing a milestone payment method that is not subject to audit by the United States Government and the Performer is not required to include this Program in any governmental audits. Additionally, as such, this Agreement establishes no requirements pertaining to use of the Performer’s accounting or timekeeping system(s).

F. Accounting and Appropriation Data

See 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.

B. Dispute Resolution Procedures

1. Any disagreement, claim or dispute between ARPA-H and the Performer concerning questions of fact or law arising from or in connection with this Agreement, and, whether or not involving an alleged breach of this Agreement, may be raised only under this Article, which describes the applicable administrative review process. Completion of this process forecloses any further administrative review and must be pursued prior to any other dispute resolution process.

2. 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. Unless waived by the Director of ARPA-H, no dispute, disagreement or misunderstanding which arose more than three

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(3) months from when the Party knew or should have known the basis of the action prior to the notification made under Article 6 (B)(3), which constitutes the basis for relief under this Article.

3. Failing resolution by mutual agreement, the aggrieved Party shall document the dispute, disagreement, or misunderstanding by notifying the other Party (through the ARPA-H AO or the Performer’s Administrator, as the case may be) in writing of the relevant facts, identify unresolved issues, and specify the clarification or remedy sought. Within five (5) working days after providing notice to the other Party, the aggrieved Party may, in writing, request a joint decision by the ARPA-H Head of Contracting Authority (HCA), and 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) calendar days after being notified that a decision has been requested. ARPA HCA and the senior executive shall conduct a review of the matter(s) in dispute and render a decision in writing within thirty (30) calendar days of receipt of such written position. Any such joint decision is final and binding.

4. In the absence of a joint decision, upon written request to the Deputy Director of ARPA- H, made within thirty (30) calendar days of the expiration of the time for a decision under Article 6 (B)(3), the dispute shall be further reviewed. The Deputy Director of ARPA-H may elect to conduct this review personally or through a designee or 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 Deputy Director of ARPA- H or designee will resolve the issue(s) and notify the Parties in writing. 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 obligated 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 shall have notified ARPA-H in writing 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. Said license is transferable only with the approval of the ARPA-H

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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) calendar 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,” in this Agreement.

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) calendar days prior to the end of the one (1) year statutory United States 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

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

b. 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) calendar days before the expiration of the response period required by the relevant patent office.

c. The Performer shall include, within the specification of any United States patent application and any patent issued covering a subjection invention, the following statement:

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“This invention was made with U.S. Government support under Agreement No. (INSERT AWARD NUMBER) awarded by the Advanced Research Projects Agency for Health. The U.S.

Government has rights in the invention.”

2. Protection of the Subject Invention as a trade secret

a. 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.

b. 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.

c. If the Government discloses a Subject Invention which is protected as a trade secret to a 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 a 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) calendar 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 Article 7(A)(1)-(3) during the course of the Agreement and the current status of each.

1. All required reporting shall be done, to the extent possible, using the i-Edison reporting website: https://nist.gov/iedison. To the extent that the reporting cannot be accomplished by use of i-Edison, 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 Article 7(A)(2)(b) and to enable the Government to obtain patent protection throughout the world in the Subject Invention.

https://nist.gov/iedison

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(c) The Performer agrees to 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 that the Performer goes out of business or otherwise exits the [INSERT DESCRIPTION] industry; or otherwise makes the Subject Inventions 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

1. Allocation of Principal Rights

(a) The Parties agree that in consideration for Government funding, the Performer intends to utilize in commercial business the Intellectual Property developed under this Agreement.

(b) With respect to Data delivered pursuant to Attachments 1 through 3 of this

Agreement, the Government shall receive rights as stipulated below and in Attachment 3 except as noted in the following two subparagraphs:

Data Rights Identifier* Data Rights Type Term GPR Government Purpose Rights In perpetuity ULR Unlimited Rights In perpetuity LR Limited Rights In perpetuity

[ WHICH OF THE ABOVE DATA RIGHTS TYPES APPLY WILL BE NEGOTIATED BASED ON

THE FINAL MILESTONE PLAN – ANY RIGHTS NOT USED WILL BE DELETED FROM THE

DEFINITIONS SECTION IN ARTICLE I AS WELL AS THE MARKINGS SECTION BELOW]

(c) With respect to the following Data deliverables, the Government shall receive BLANK Rights (this may be modified by the AO depending on the rights asserted by the performer):

1. Technical Status Reports

2. Milestone Reports

3. Final Report(s)

(d) The Government may require delivery of Data developed or generated under this

Agreement, if not previously delivered, 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.

Upon the Government making such a request, the parties will negotiate in good faith the applicable Data

Updated 3/14/2024 rights for the requested Data prior to delivery, and 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 Article 7(A)(5), the Performer agrees to deliver at no additional cost to the Government all Data necessary to achieve practical application of a specified Subject Invention. The Government shall retain Unlimited Rights, as defined in Article 1, Definitions of this Agreement, 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) calendar 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 of Data

(a) Any Data delivered under this Agreement shall be marked with the following legends, as applicable:

“GOVERNMENT PURPOSE RIGHTS

Agreement Number: 1AYSAX00000X Contractor 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 United States Government is a party, including cooperative agreements with international or multi-national organizations or sales or transfers by the United States 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

Prime Agreement No.: 1AYSAX00000X 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.”

“UNLIMITED RIGHTS

Agreement Number: 1AYSAX00000X Contractor 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, perform, display, release, or disclose, in whole or in part, in any manner and for any purposes whatsoever, and to have or permit other to do so as well.”

C. Lower Tier Agreements

The Performer shall include this Article, suitably modified, in all subcontracts or lower tier agreements, for experimental, developmental, or research work.

ARTICLE 8: FOREIGN ACCESS TO TECHNOLOGY

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

A. General

The Parties agree that research findings and technology developments arising under this Agreement may constitute a significant enhancement to the security and to the economic vitality of the United States.

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 CFR Parts 120-130) and the Department of Commerce’s Export Administration Regulations (EAR)(15 CFR Parts 730-774) regarding export-controlled items, or the Performer's responsibility to comply with all applicable laws and regulations regarding export-controlled items and the handling of classified 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 ITAR and shall consult with the Department of Commerce regarding any questions relating to compliance with EAR.

B. Restrictions on Sale or Transfer of Technology to Foreign Firms or Institutions

1. In order to best capitalize on the financial investment by the Government in the program and promote the national security interests of the United States, ARPA-H reserves the right to be notified and discuss options with the Performer before Performer’s transfer Intellectual Property developed or generated under this Agreement to a Foreign Firm or Institution. It is not ARPA-H’s intention to unduly restrict the Performer’s ability to promote and sell its products and services in the global market. ARPA- H’s intention is 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 exclusive licensing of the Intellectual Property developed or generated under this Agreement. A transfer does not include:

(a) Sales of products or components, and non-exclusive licenses of intellectual property related to sales of products or components (i.e., software, documentation), in the course of normal business practice; or

(b) Licenses of software or documentation related to open-source software; or

(c) Transfers to foreign subsidiaries of the Performer for purposes related to the performance of this Agreement, or

Updated 3/14/2024

(d) Transfer which provides access to Technology to a Foreign Firm or Institution which is an approved source of supply or source for the conduct of research under this Agreement provided that such transfer shall be limited to that necessary to allow the firm or institution to perform its approved role under this Agreement.

2. Notwithstanding any provisions of this Article, the Performer agrees to transfer Intellectual

Property developed or generated under this Agreement to United States firms and institutions or to a firm or institution that agree to substantially manufacture products embodying the Intellectual Property or produced through the use of the Intellectual Property in the United States. If the Performer is unsuccessful in finding a firm or institution that is capable of manufacturing substantially in the United States, the Performer may request a waiver to this requirement from ARPA-H. In doing so, the Performer shall illustrate to ARPA-H the Performer has made all reasonable efforts to find a firm or institution capable of manufacture substantially in the United States.

3. In any event the Performer requests a waiver under Article 8(B)(2), the Performer shall provide written notice to the AOR and the ARPA-H AO at least sixty (60) calendar days prior to the proposed date of transfer. Such notice shall cite this Article and shall state specifically what is to be transferred and the general terms of the transfer. Within thirty (30) calendar days of receipt of the Performer’s written notification, the ARPA-H AO shall advise the Performer whether it consents to the proposed transfer. In cases where ARPA-H does not concur or sixty (60) calendar days after receipt and ARPA-H provides no decision, the Performer may utilize the procedures under Article 6, Disputes. No transfer shall take place until a decision is rendered.

4. In the event the Performer transfers the intellectual property developed or generated under this Agreement without ARPA-H’s written assent (a) the Performer shall refund to ARPA-H the full amount of Government 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 United States 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.

C. Lower Tier Agreements

The Performer shall include this Article, suitably modified, to identify the Parties, in all subcontracts or lower tier agreements, regardless of tier, for experimental, developmental, or research work.

ARTICLE 9: TITLE TO AND DISPOSITION OF PROPERTY

A. Title to Property

The Performer will acquire property with an acquisition value greater than $5,000 under this Agreement, as set forth in Attachment 5, which is necessary to further the research and development goals of this Program and is not for the direct benefit of the Government. Title to this property shall vest in the Performer upon acquisition. Title to any other items of property acquired under this Agreement with an acquisition value of $5,000 or less shall vest in the Performer upon acquisition with no further obligation of the Parties unless otherwise determined by the AO. Should any other item of property with an acquisition value greater than $5,000 be required, the Performer shall obtain prior written approval of the AO. Title to this property shall also vest in the Performer upon acquisition. The Performer shall be responsible for the 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 set forth in this Agreement or any other items of property with an acquisition value greater than $5,000 will be dispositioned in one of the following manners, depending on the property in question, and a recommendation from the PM.

1. 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 ARPA-H; or

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

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

4. Any other ARPA-H approved disposition procedure.

ARTICLE 10: PUBLIC RELEASE OR DISSEMINATION OF INFORMATION

There are no publication restrictions. The Performer and any subcontractors/subrecipients may publish and make public communications and presentations make regarding the results of their work under this Agreement without any prior written approval. Additionally, articles for publication or presentation will contain a statement on the title page worded substantially as follows:

“This research was funded, in part, by the U.S. Government. The views and conclusions contained in this document are those of the authors and should not be interpreted as representing the official policies, either expressed or implied, of the U.S. Government.”

Or

1. Except with regard to subcontractors, team members, or other program participants, the Performer agrees to restrict dissemination or publication of information developed or generated under this Agreement without prior written approval by ARPA-H.

2. The following information or documents will not be subject to the requirements of Paragraph 1 of this Article.

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

(b) Papers prepared in response to academic requirements which are not intended for public release outside the academic institution, or

(c) Information or documents related to program activities that have been determined to be fundamental research.

3. The Performer shall submit any proposed public releases that reference the United States Government, or ARPA-H in any form or references the program name or the names of any government staff for review and approval to the ARPA-H Division of Communication (DOC). Public releases may include press releases, specific publicity or advertisement, and publication or presentation, but exclude those relating to open sourcing or licensing, sales or other commercial exploitation of products, services, Updated 3/14/2024 or technologies. In addition, articles for publication or presentation that mention ARPA-H in any form, or the name of the program will contain a statement on the title page worded substantially as follows:

“This research was funded, in part, by the U.S. Government. The views and conclusions contained in this document are those of the authors and should not be interpreted as representing the official policies, either expressed or implied, of the U.S. Government.”

ARTICLE 11: CIVIL RIGHTS ACT

This Agreement is subject to the compliance requirements of Title VI of the Civil Rights Act of 1964 as amended (42 U.S.C. § 2000d) relating to nondiscrimination in Federally assisted programs. The Performer has signed an Assurance of Compliance with the nondiscriminatory provisions of the Act.

ARTICLE 12: SECURITY

The Performer, and any applicable subcontractor, will be required to follow…