ARPA-H-SOL-25-125_Attach1_Model OT.docx

This is a sample Other Transaction (OT) Agreement for the PROSPR program. This sample agreement includes Articles and language that are regularly used in ARPA-H OTs as well as language anticipated to be applicable to resulting PROSPR project awards.

As stated in the PROSPR Innovative Solutions Opening (ISO), the model is provided to expediate subsequent negotiations if selected for a potential award. However, the Government Agreements Officer (AO) shall have sole discretion to negotiate the Agreement terms and conditions with the Proposer, to include the inclusion, removal, or revision of terms and conditions (e.g. “Articles”) stated herein.

Any text highlighted in turquoise may be information the Government asks to be provided by Proposers, and text highlighted in yellow is information usually provided by the Government; however, any final language will be determined by the cognizant ARPA-H AO and agreed upon by both Performer and AO. Any text in red is notes for the Proposer.

OTHER TRANSACTION AGREEMENT

BETWEEN

INSERT PERFORMER NAME AND ADDRESS, UEI

AND

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

CONCERNING

PROactive Solutions for Prolonging Resilience (PROSPR)

Agreement No.: 1AYSAX00000X Authority: 42 U.S.C. 290(c)(g)(1)(D) Technical area (TA)1: Total Amount of the Agreement: $ X,XXX,XXX (Base and Unexercised Phases/Options) (Includes Performer and Government Funding) Phase I (Base): $ X,XXX,XXX Phase II (Option, Unexercised): $ X,XXX,XXX Phase III (Option, Unexercised): $ X,XXX,XXX Phase IV (Option, Unexercised): $ X,XXX,XXX Phase V (Option, Unexercised): $ X,XXX,XXX

Technical area (TA) 2: Total Amount of the Agreement: $ X,XXX,XXX (Base and Unexercised Phases/Options) (Includes Performer and Government Funding) Phase I (Base): $ X,XXX,XXX Phase II (Option, Unexercised): $ X,XXX,XXX Phase III (Option, Unexercised): $ X,XXX,XXX Phase IV (Option, Unexercised): $ X,XXX,XXX Phase V (Option, Unexercised): $ X,XXX,XXX

Technical area (TA) 3: Total Amount of the Agreement: $ X,XXX,XXX (Base and Unexercised Phases/Options) (Includes Performer and Government Funding) Phase I (Base): $ X,XXX,XXX Phase II (Option, Unexercised): $ X,XXX,XXX Phase III (Option, Unexercised): $ X,XXX,XXX Phase IV (Option, Unexercised): $ X,XXX,XXX

Funding Obligated:

Date of Agreement:

This Agreement is entered into between the United States of America, represented by The Advanced Research Projects Agency for Health (ARPA-H or Government), represented by Department of Interior (DOI) and INSERT PERFORMER NAME pursuant to and under United States Federal law.

FOR INSERT PERFORMER NAME

FOR THE GOVERNMENT

ADVANCED RESEARCH PROJECTS AGENCY FOR HEALTH

(Name, Title) (Name, Title)

TABLE OF CONTENTS

ARTICLES

ATTACHMENTS

ARTICLE 1: SCOPE OF THE AGREEMENT

A. Program Background and Objectives

The PROactive Solutions for Prolonging Resilience (PROSPR) program aims to develop interventions that extend healthspan by 20 years by targeting the underlying causes of age-induced health loss and thereby prevent the onset of multiple age-related diseases simultaneously.

Despite major advances in scientific discovery and clinical interventions that have added years of life expectancy, there has not been a corresponding increase in healthspan, the number of years spent in good health. Instead, the prevalence of chronic diseases in American adults has dramatically increased, particularly worsening with age. In the United States and elsewhere, medicines and scientific research are heavily focused on reactionary, post-symptomatic illness treatment, despite overwhelming evidence that early interventions are far more effective and many diseases preventable.

The PROSPR program is a 5-year program that aims to transform geriatric medicine into a personalized, comprehensive, preventive care model. By focusing on early health loss and developing second-generation interventions, PROSPR seeks to preserve health in aging individuals before chronic diseases develop. This will address the critical need for proactive health management and reducing the burden of aging-related health issues on the healthcare system.

Current treatments primarily address symptoms of age-related diseases after they manifest, rather than preventing them. This results in high healthcare costs and reduced quality of life for aging populations. There is a significant gap in the development of healthspan-extending therapeutics due to the substantial time and cost investments required for long-term clinical trials. The PROSPR program addresses this gap by first reducing the time and cost investments that currently prevent a thriving healthspan therapeutics industry from developing. By directly demonstrating that human age-induced health outcomes can be predicted by biochemical and physiological measures in a single composite intrinsic capacity (IC) score, PROSPR will remove the need for 20-year clinical efficacy trials. By focusing second generation interventions on those that target early health loss, PROSPR aims to preserve health in aging individuals before chronic diseases can develop.

B. Project Scope

1. The objective of this Other Transaction (OT) Agreement within the overall PROSPR Program Portfolio is to accomplish the research and development efforts described in the Statement of Work (SOW) (Attachment 1), which falls within TA(s) XX. All work shall be completed within the timeframes established in the Schedule of Milestones and Payments (Attachment 2).

2. This Agreement is not intended to be, nor shall it be construed as, by implication or otherwise, a legal partnership, a corporation, or other business organization. Unless specifically indicated otherwise in this Agreement, including Attachments, all effort is assumed to be accomplished by the Performer.

C. Project Duration

Unless modified, the Agreement shall be for an initial period of up to five years from the date of Program/Project Kick-off, which includes four option periods as estimated below in the table. Options will be exercised as described in Article 3.

B. Definitions

The following definitions apply in this Agreement whether the terms are capitalized throughout the document or not:

Agreement: The body of this Agreement and Attachments 1 – X which are expressly incorporated in and made a part of the Agreement. Unless explicitly indicated otherwise in the Agreement, all requirements of the PROSPR Solicitation, ARPA-H-SOL-25-125 (e.g., TA Metrics) are incorporated into this Agreement as minimum requirements/standards.

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 (AO) 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.

Background Intellectual Property (Background IP): Only trade secrets, patents, article, or non-provisional patent applications owned or controlled by the Performer, or any subawardees, that exist prior to the Effective Date of this Agreement or which are conceived and otherwise created outside the scope of this Agreement.

Covered Application: The social networking service TikTok or any successor application or service developed or provided by ByteDance Limited, or an entity owned by ByteDance Limited.

Data: Recorded information, regardless of form or method of recording, which includes, but is not limited to, copyrightable material; scientific/technical/medical data; unpatentable computer software, including programs, code, documentation and databases; trademarks; and mask works. The term does not include financial, administrative, cost, pricing, or management information, Subject Inventions, as defined in this Article; or original patient medical records, original research notebooks, or original source documents. As it relates to this Agreement, data is considered a subset of IP.

Effective Date: The effective date of this Agreement, and/or future modifications, is the date of the AO’s signature unless a different date is specified in the action signed by the AO. This award and any following modifications are not fully executed without the signature of the AO.

Federal Data: Data created, collected, processed, maintained, disseminated, disclosed, or disposed of by or for the Federal Government, in any medium or form.

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 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.

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: 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.

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: Performing Entity 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, 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: The overall PROSPR Program. The Program goals and objectives will be accomplished through award of Project OTs to Performers. The ARPA-H Program Manager (PM), Dr. Andrew Brack, is the head of the PROSPR Program and has no Performer counterpart.

Project: The individual pieces of the PROSPR Program through which Performers accomplish the research and development as outlined in their individual SOWs. Performers manage projects through a required Project Manager and Principal Investigator.

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

Subawardee: A business or organization that performs work for the Performer that is related to and necessary for the performance of the Agreement. The subawardee(s) shall receive project guidance and direction from the Performer, as the subawardee’s relationship rests with the Performer (not the Government). Subawardees include any teaming agreement for support/effort external to the Performer – traditional subawardee agreements, vendors and commercial contractors, [1099] consultants, etc.

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

Support Contractor or Consultant: A contractor under a contract or agreement, including through a subcontract or subagreement, 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 receive access to data for the performance of a Government contract or agreement. The same requirements and standards of conduct (e.g., Non-Disclosure Agreements) apply to support personnel whether they are referred to as a consultant or a contractor.

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.

ARTICLE 2: MANAGEMENT OF THE PROJECT

A. Project Management and Structure

1. The Performer shall be responsible for the overall technical and administrative management of the project. Technical planning and execution shall remain with the Performer, including all necessary subawardee management and coordination. The ARPA-H AOR shall be responsible for the review and verification of milestones.

2. The Performer’s Project Management team will consist of, at a minimum, a committed Project Manager and a Principal Investigator (PI).

B. Project and Program Meetings

1. The Performer shall participate in the Program Kick-off meeting with up to X team members in-person. A virtual option will be available for other team members. The Government expects the Kick-off meeting will be held within ~10 days of Agreement award and will be for 1-2 days.

2. All key participants of the Performer team (e.g., PI’s, Project Manager, Financial/Contracts/OT representatives, commercialization and/or Technology Transfer Office representatives, and any other critical decision makers) shall be available for virtual Monthly Status Report (MSR) Meetings estimated for 1-2 hours each month. The Performer will provide the standardized PowerPoint and Excel files (see Attachment 5) by the Xth business day of each month. Should non-key participants be necessary, the Government will notify the Performer in advance after reviewing the submissions. The Government intends to structure the meeting to address financial/contractual items first to allow those participants to leave prior to the technical/science updates.

3. Up to two times per year (estimated at 6-month intervals), the MSR Meetings may be in-person at the Performer’s site and be more intensive (e.g., to include laboratory tours and direct assessment of scientific rigor) with an estimated duration of 4-6 hours. Based on circumstances, these progress meetings may be held virtually and/or extend for more than 1 day. The in-person presentation(s) of data at these 6-month (and/or annual reviews) will be inclusive and summative of prior MSRs. Performer personnel shall be available in person while subawardee personnel at other locations may participate virtually. The MSR submissions for the more intensive progress meetings shall be sent by the Xth business day of the month.

C. Agreement Deliverables

1. The following table provides a summary of the Agreement deliverables.

2. Please see Attachment 3 for specific details and descriptions of tasks/deliverables and specific meetings.

*In cases where terms vary slightly from terminology in Attachment 1 SOW, the above are not intended to represent additional requirements – they are the same and are as described in greater detail in Attachment 3.

D. Travel

1. The Performer may assume up to X team members will travel for the post award kick-off.

2. If held, the Government will travel to the Performer’s site for the biannual/annual in-person meetings. At the Performer’s discretion, subawardee personnel may also participate in person; but that is not required to meet the intent of the meetings.

3. Travel reimbursed with PROSPR/award funds is only allowable for the Project requirements described above. Performer team members shall not receive reimbursement of PROSPR funding for conference attendance and/or other events not directly related to this Project and the PROSPR Program.

ARTICLE 3: 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. Notwithstanding any other provision of this Agreement, the AO 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 AO.

A. Government Points of Contact:

Agreements Officer’s Representative (AOR):

To be designated in writing by the AO

B. Performer Points of Contact

Performer’s Administrative/Contracting:

[INSERT NAME]

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 SOW would be beneficial to Program objectives. Recommendations for modifications, including justifications to support any changes to the SOW 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 2 is formally revised by the AO and made part of this Agreement.

2. The AOR shall be responsible for the review and verification of any recommendations to revise or otherwise modify Attachment 1, Attachment 2, or other proposed changes to the terms and conditions of this Agreement.

4. A bilateral modification is a modification to the Agreement that is signed by the Performer and the AO. Bilateral modifications will be used for all other changes to the Agreement not of the unilateral type identified above – to include terminating the Agreement per Paragraph E.

D. Agreement Options

1. If the Government chooses to exercise an Option, it will be exercised unilaterally no later than the end date of the current period; and

2. If an Option is exercised, the Term of the Agreement is extended as outlined in Article 1 Paragraph C.

E. Termination Provisions

Subject to a reasonable determination the Project will not produce beneficial results, the Government may terminate this Agreement by written notice. In the event of a termination of the Agreement, it is agreed disposition of IP developed under this Agreement, shall be in accordance with the provisions set forth in Article 6. The Government and the Performer will negotiate in good faith a reasonable and timely adjustment of all outstanding issues between the Parties. Failure of the Parties to agree to a reasonable adjustment will be resolved pursuant to Article 5.

The Performer may request a termination for consideration by the Government. Should the Government accept the Performer’s request for termination prior to completion of the current Phase, the Performer may be required to repay a proportionate amount of ARPA-H funding used for property valued in excess of $20,000. In no case will the Government be obligated to pay the Performer beyond the last completed and paid milestone if the Performer requests the termination.

ARTICLE 4: 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 or by modification to the Agreement; and only to the extent the Performer successfully completes the established milestones. At the time each payable milestone is funded, it will be fully funded.

B. Payments

1. The Parties agree 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 3. After written verification of the accomplishment of the milestone by the AOR, the Performer will submit their invoice through the Payment Management Services (PMS), as detailed in Article 4(D)(3) and shall notify the AOR and AO via email upon submission in PMS.

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

The Performer shall (i) maintain an active registration in the System for Award Management (SAM) throughout the life of the award, (ii) ensure an Electronic Business Point of Contact is designated in SAM 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 3, "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 2 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 2.

Payee Information: Unique Entity ID (UEI): XXXXX

Fiscal Information for the Payment Management System (PMS):

· Payment System Identifier:

· Document Number:

· PMS Account Type:

· Fiscal Year:

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

E. Financial Records and Reports

Financial reporting shall be as outlined in the Monthly Status Report (Attachment 5).

F. Records Retention and Government Access

The Department of Health and Human Services (HHS), 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, which shall be for three years after completion of the agreement (including all options). The rights of access in this paragraph do not extend to the Performer’s financial records.

G. Audits and Accounting System Compliance

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

ARTICLE 5 : 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 (3) months from when the Party knew or should have known may be brought forth 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 PROJECT 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. The 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 PROJECT 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 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 6: INTELLECTUAL PROPERTY RIGHTS

A. Patent Rights

1. Allocation of Principal Rights – Performer

(a) Unless the Performer has 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 non-exclusive, 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 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 non-exclusive, non-transferable, irrevocable, paid-up Government Purpose license in the Subject Invention throughout the world, regardless of the protection method chosen.

(b) The Performer agrees to engage in good faith efforts to collaborate with other entities, including but not limited to academic institutions, non-profit organizations, and commercial entities, to promote the development and dissemination of the Subject Invention. The Performer will also consider requests for additional non-exclusive licenses on commercially reasonable terms to entities capable of demonstrating a commitment to further development and commercialization of the Subject Invention, in alignment with ARPA-H’s mission to foster innovation and address public health challenges. However, such licenses shall not diminish the Performer's ability to generate revenue or primary control over the Subject Invention.

(c) 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.

(d) 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 the appropriate 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:

“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.

b. 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.

c. In its 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.

d. 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.

e. 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. 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.

(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. Responsible Use of Innovation

(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 the Intellectual Property developed under this Agreement in commercial business.

(b) With respect to Data developed, generated and/or 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:

[ WHICH OF THE ABOVE DATA RIGHTS TYPES APPLY WILL BE NEGOTIATED BASED ON THE FINAL MILESTONE PLAN – ANY NOT USED WILL ALSO BE DELETED FROM THE DEFINITIONS SECTION IN ARTICLE 1 AS WELL AS THE MARKINGS SECTION BELOW. OTHER DATA RIGHTS CATEGORIES CAN BE CREATED, DEFINED, AND INCLUDED IN THE AGREEMENT IN ADDITION TO OR INSTEAD OF THOSE LISTED ABOVE, BASED ON THE CIRCUMSTANCES AND THE NEEDS OF THE PARTIES]

(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):

(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 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 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. Responsible Use of Innovation Data

(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, Scope of the 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:

“UNLIMITED RIGHTS

Agreement Number: 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, 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 7: FOREIGN ACCESS TO INTELLECTUAL PROPERTY

This Article shall remain in effect during the term of the Agreement and for 5 (five) years thereafter.

A. General

The Parties agree that intellectual property developed and/or generated 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 Intellectual Property to Foreign Firms or Institutions

1. In return for the financial investment by the Government in the Project and to 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 transfer Intellectual Property developed or generated under this Agreement to a foreign entity. 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 licenses of intellectual property related to sales of products or components (i.e., software, documentation),

(b) Non-exclusive licenses of intellectual property given in the normal course of business practices,

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

(d) 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 role under this Agreement.

(e) Any activities that have been designated by ARPA-H as basic research which is not subject to publication restrictions, or

(f) Any circumstances that have been included in Article 8(D).

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 licenses exclusive right to use or sell the intellectual property in the United States only to a person or entity that agrees that any product utilizing the intellectual property will be manufactured substantially in the United States. If the Performer has made reasonable but unsuccessful efforts to identify and license to potential licensees to manufacture in the United States or if the Performer, after reasonable efforts, has determined that domestic manufacturing is not commercially feasible, the Performer shall notify ARPA-H in writing of its specific determination and request a waiver. ARPA-H may waive this requirement and the Government 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 agrees to provide timely written notice to ARPA-H no less than 45 days prior to any proposed transfers of intellectual property developed under this Agreement to a foreign entity. The written waiver request will cite this Article and specifically state what is to be transferred, to whom, and the general terms of the transfer. ARPA-H will respond within 30 days of receipt of the waiver request whether the ARPA-H 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 Article 8(B)(5).