AMENDMENT 6 APPENDIX A_Sample Terms and Conditions_Revised Template 12-19-2023.pdf

For Internal Use Only (do not incorporated into final agreement and do not send to Recipient)

T&C CHANGES LOG

Version # Author Effective Date Changes Made

1.0 Director of AMB 8/31/2023 N/A - Original Document

AGREEMENT # OT2ODXXXXX-0X

[RECIPIENT INSTITUTION]

[(Contact) PI NAME]

[AWARD #]

OTHER TRANSACTIONS AGREEMENT

BETWEEN

RECIPIENT LEGAL (SAM.GOV) INSTITUTION NAME

Recipient Address

AND

NATIONAL INSTITUTES OF HEALTH (NIH)

OFFICE OF THE DIRECTOR

ALL OF US RESEARCH PROGRAM

6710B Rockledge Drive, 4th Floor

Bethesda, MD 20817

CONCERNING

<INSERT RESEARCH AND DEVELOPMENT TITLE>

This Agreement is entered into between the National Institutes of Health (NIH), an agency of the United States of America, and RECIPIENT LEGAL (from SAM.gov) ENTITY NAME pursuant to and under United States Federal law, as applied by the federal courts in the District of Columbia.

FOR RECIPIENT INSTITUTION: FOR NIH:

[RBO Name] Date [OTAO Name] Date Recipient Business Official (RBO) Other Transactions Agreements Officer (OTAO)

ARTICLES

ARTICLE I SCOPE OF THE AGREEMENT

ARTICLE II TERM

ARTICLE III MANAGEMENT OF THE PROJECT

ARTICLE IV AGREEMENT ADMINISTRATION

ARTICLE V OBLIGATION AND PAYMENT

ARTICLE VI DISPUTES

ARTICLE VII PATENT RIGHTS

ARTICLE VIII DATA RIGHTS, PARTICIPANT- DERIVED RESOURCES, DELIVERABLES

ARTICLE IX DATA AND INFORMATION SHARING

ARTICLE X DATA AND INFORMATION PRIVACY AND SECURITY

ARTICLE XI FOREIGN ACCESS TO TECHNOLOGY

ARTICLE XII ADDITIONAL ADMINISTRATIVE REQUIREMENTS

ARTICLE XIII TITLE TO AND DISPOSITION OF PROPERTY

ARTICLE XIV APPLICABLE STATUTES AND REGULATIONS

ARTICLE XV ORDER OF PRECEDENCE

ARTICLE XVI EXECUTION

ATTACHMENTS

ATTACHMENT 1 STATEMENT OF OBJECTIVES AND MILESTONES (SOM)

ATTACHMENT 2 STATEMENT OF BUDGETARY PROJECTIONS (SBP)

ATTACHMENT 3 ADDITIONAL DATA AND INFORMATION SECURITY REQUIREMENTS

ATTACHMENT 4 DATA RIGHTS IDENTIFICATION AND ASSERTIONS

ATTACHMENT 5 SAMPLE: MONTHLY FINANCIAL REPORTING TEMPLATE

ARTICLE I. SCOPE OF THE AGREEMENT

A. Background

This Agreement supports the All of Us Research Program (All of Us).

All of Us is a historic effort to gather data from at least 1 million diverse people living in the United States and its territories, with the goal of accelerating health research and medical breakthroughs, and enabling individualized prevention, treatment, and care. The program has created the Researcher Workbench, a secure cloud-based research resource to inform thousands of studies, covering a wide variety of health conditions. Researchers will use data from the program to learn more about how individual differences in lifestyle, environment, and biological makeup can influence health and disease.

The All of Us Researcher Workbench may create more opportunities to:

● Know the risk factors for certain diseases

● Figure out which treatments work best for people of different backgrounds

● Better understand health disparities and improve health equity

● Learn how technologies can help us take steps to be healthier

Knowledge gained from observational cohort studies has dramatically advanced the prevention and treatment of diseases. Many of these cohorts, however, are small, lack diversity, or do not provide comprehensive information about participants. The All of Us Research Program is enrolling a diverse group of people who may contribute a range of data. These data include information from health questionnaires, electronic health records (EHRs), physical measurements, the use of digital health technology, and the collection and analysis of biospecimens. The program aims to make research results accessible to participants, and it is developing new approaches to generate, access, and make data broadly available to registered researchers.

B. Definitions In this Agreement, the following definitions apply:

Agreement: This Agreement, modifications to this Agreement, and any Attachments or other documents that are expressly incorporated in and made a part of the Agreement, including but not limited to, Attachments 1, 2, 3, 4 and 5. The official, legally binding document between the Government and the Recipient. This Agreement is not intended to be, nor shall it be construed as, by implication or otherwise, a partnership, a corporation, or other business organization.

Award: The provision of funds by NIH, based on an approved application and budget or progress report, to an organizational entity or an individual to carry out a project or activity.

Data: Recorded information, regardless of form or method of recording, which includes but is not limited to, technical data, software, mask works, programs, firmware, technical data, images, figures, charts, forms, and copyrightable works. The term does not include financial, administrative, cost, pricing or management information, and does not include subject inventions.

Deliverables: Any tangible or intangible work product including Data, Inventions, Know-How, and Materials (including third party work product including Data, Inventions, Know-How, and Materials) provided by Recipient to the NIH as a result of the performance of work under the Statement of Objectives and Milestones (SOM).

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, including a firm or institution located in a country other than the United States and its territories that is subject to the laws of that country, regardless of the citizenship of the proposed Program Director/Principal Investigator (PD/PI).

Government: The United States of America, as represented by the Office of the Director (OD) / National Institutes of Health (NIH)/All of Us Research Program.

Government Purpose Rights: The rights to use, duplicate, or disclose Data, 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.

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, processes, ideas, approaches, concepts, techniques, technical solutions, methods, procedures, specifications, and trade secrets.

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

Materials: Tangible materials including, hardware, devices, apparatus, and machines.

Notice of Award (NoA): The system-generated document signed by an Other Transactions Agreements Officer that funds an Other Transaction (OT) award or modification; references

Federal funding limits and obligations, and provides the documentary basis for recording the obligation of Federal funds in the NIH accounting system. For this Agreement, the NoA is utilized as a funding obligation document only and is not incorporated into this Agreement.

Other Transactions (OT): Other Transactions (OT) awards are not grants, cooperative agreements, or procurement contracts. They provide considerable flexibility to the government to establish policies for the awards, so policies and terms for individual OT awards may vary between awards. Each award is therefore issued with a specific Agreement, which is negotiated with the Recipient and details specific terms and conditions for that award. Program and administrative policies and the terms and conditions of individual awards are intended to supplement, rather than substitute for, governing statutory and regulatory requirements.

Awards or a specified subset of awards also may be subject to additional requirements, such as those included in executive orders and appropriations acts, conditions on activities and expenditure of funds in other statutory or regulatory requirements, including any revisions in effect as of the beginning date of the next funding segment. The terms and conditions of the resulting OT awards are intended to be compliant with governing statutes.

Other Transactions Agreements Officer (OTAO): Individual at NIH responsible for legally committing the government to an Other Transaction (OT) award and to the Agreement through which terms and conditions are established, and for the administrative and financial aspects of the award.

Other Transactions Agreements Specialist (OTAS): An NIH designee of the OTAO for administrative and financial aspects of the award.

Other Transactions Program Official (OTPO): The NIH official responsible for programmatic oversight and direction of the work performed under the Statement of Objectives and Milestones (SOM). Individual authorized to provide scientific, technical, and programmatic direction to the Recipient on behalf of the government.

Party: Includes the NIH, or the Recipient, or both.

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 Federal regulations, available to the public on reasonable terms.

Principal Investigator/Program Director (PI/PD): Individual designated by the Recipient to have the appropriate level of authority and responsibility to direct the project or program supported by the Agreement.

Program: Research and development being conducted by the Recipient, as set forth in Article I, paragraph E.

Recipient: [Institution Legal Entity Name (from SAM.gov)], the entity responsible for performing the administrative and programmatic activities described in this Agreement.

Recipient Business Official (RBO): Individual responsible for the legal commitment by the Recipient and for the administrative and financial reporting compliance with terms and conditions of the Agreement. In signing this OT bilateral Agreement, the RBO certifies that the Recipient will comply with all applicable assurances and certifications referenced in the Agreement. This individual’s signature further certifies that the Recipient will be accountable both for the appropriate use of funds awarded and for the performance of the OT supported project or activities. This individual is responsible for ensuring that the Recipient complies with applicable Federal laws and regulations, including required certifications and assurances, its application and terms and conditions of this Agreement. All official correspondence must be submitted by the RBO.

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

Technology: All Data, Know-How, and Materials developed under this Agreement, and Subject Inventions.

Unlimited Rights: The rights to use, disclose, reproduce, prepare derivative works, distribute copies to the public, and perform publicly and display publicly, in any manner and for any purpose, and to have or permit others to do so.

C. Authorization This Other Transactions award is made under the Other Transaction Authority (OTA) as authorized by section 402(n) of the Public Health Service Act as amended [42 U.S.C. 282(n)].

Unless otherwise stated in this Agreement, this Agreement is not governed by the Federal Acquisition Regulation (FAR), 2 CFR 200, the NIH Grants Policy Statement, or administrative regulations governing grants.

D. Scope The Recipient shall perform a coordinated research and development project (hereafter referred to as “Project”) designed to develop the All of Us Research Program. The research shall be carried out in accordance with the “Statement of Objectives and Milestones” (SOM) incorporated into this Agreement as Attachment 1.

The NIH will have continuous involvement with the Recipient in the administration of this Project. The NIH will obtain access to project results and certain rights in patents and data pursuant to the terms and conditions of this agreement. NIH and the Recipient are bound to each other by a duty of good faith in achieving the Program objectives.

Subject to the availability of funds, the Recipient shall be paid for meeting its objectives and milestones.

ARTICLE II. TERM

A. Term of this Agreement The Agreement commences on Month XX, 202X and continues for the period through Month, XX, 202X or for other such period as mutually agreed to by the Parties in writing, subject to the availability of funds. 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. If all funds are expended prior to the project end date, the Parties have no obligation to continue performance and may elect to end this Agreement at that point.

B. Termination Provisions

1. The NIH may terminate this Agreement in whole or in part by written notice to the Recipient, if the OTAO determines that a termination is in the Government’s best interest, provided that such written notice is preceded by meeting consultation between the Parties.

2. The Recipient may terminate this Agreement by giving the OTAO ninety (90) calendar days written notification of its intent to do so, provided that such written notice is preceded by consultation between the Parties.

3. The NIH and the Recipient shall negotiate in good faith a reasonable and timely adjustment of all outstanding issues including amounts due between the Parties as a result of termination, which may include non-cancelable financial commitments. The Government has no obligation to pay the Recipient beyond the last completed and paid milestone if the Recipient decides to terminate.

4. Within 30 days of notice of termination, the Recipient shall develop a Termination

Transition Plan to be approved by NIH, which must include the following terms:

a. Information security, including confidentiality, integrity, and availability of Data and systems

b. Data transfer process for NIH owned Data

c. Relevant records and information to effect termination and Data transfer of NIH owned Data

d. Property disposition or property transfers, if applicable

e. Any other terms deemed necessary by NIH

5. The proceeds of any transfer or disposition of property shall be applied to reduce any payments to be made by the Government.

6. In the event that this Agreement is terminated, the NIH shall have paid-up rights in Data owned by NIH as described in Article VIII, Data Rights, Participant-Derived Resources, Deliverables.

7. Failure of the Parties to agree to a reasonable adjustment shall be resolved pursuant to

Article VI, Disputes. The NIH has no obligation to pay the Recipient beyond the last completed and paid milestone if the Recipient fails to comply with the terms and conditions of this Agreement.

C. Enforcement, Termination If Recipient has failed to materially comply with the terms and conditions of this Agreement, NIH may take one or more enforcement actions, which can include disallowing costs, withholding of further awards, or wholly or partly suspending the OT award, pending corrective action. NIH may also terminate the OT award with no obligation to pay the Recipient beyond the last completed and paid milestone.

NIH may suspend (rather than immediately terminate) the OT award and allow the Recipient an opportunity to take appropriate corrective action before NIH makes a termination decision;

however, NIH may decide to terminate the award if the Recipient does not take appropriate corrective action during the period of suspension. NIH may immediately terminate an OT award when necessary, such as to protect the public health and welfare from the effects of a serious deficiency.

An NIH All of Us OT award may also be terminated, partially or totally, by the Recipient. If the Recipient decides to terminate a portion of an OT award, NIH may determine that the remaining portion of the award will not accomplish the purposes for which the award was originally made.

In any such case, NIH will advise the Recipient of the possibility of termination of the entire OT award and allow the Recipient to withdraw its termination request. If the Recipient does not withdraw its request for partial termination, NIH may initiate procedures to terminate the entire award with no obligation to pay the Recipient beyond the last completed and paid milestone.

The Recipient may terminate this Agreement by giving the NIH Other Transactions Agreements Officer (OTAO) ninety (90) calendar days written notification of its intent to do so, provided that such written notice is preceded by consultation between the Parties.

If the NIH decides to terminate an OT award, the termination of the award will be considered a unilateral change and the Recipient will not have the right to appeal. Although a decision is made to terminate an award, the Recipient must continue to comply with the Record Retention and Access requirements.

D. Flow Down / Lower Tier Agreements

1. Definitions

a. “Lower Tier Agreement” means a written agreement between the Recipient and a

Sub-Recipient.

b. “Sub-Recipient” means any legal entity that, pursuant to a Lower Tier Agreement, uses Federal funds to carry out a purpose consistent with NIH’s statutory authorities, has its performance measured in relation to whether the objectives of the NIH program were met, or has responsibility for programmatic decision making. A Sub-Recipient is distinguished from a contractor providing goods and services within normal business operations for the Recipient’s own use or that are ancillary to the operation of the NIH program, provides similar goods or services to many different purchasers, and normally operates in a competitive environment. The Recipient is responsible for determining whether a legal entity is a Sub-Recipient on a case-by-case basis, consistent with any additional guidance supplied by the NIH to support these determinations.

2. Authorization

The Recipient is authorized to enter into Lower Tier Agreements with Sub-Recipients provided Recipient complies with Item 3. Authorization Process of this Section.

3. Authorization Process

a. Pursuant to Article III Paragraph A of this Agreement, either Party may recommend to the other the need for a Lower Tier Agreement. This recommendation should include a written justification describing the need for a Lower Tier Agreement and may also include, if feasible, the proposed scope of work, the identity of the suitably qualified Sub-Recipient(s), and the anticipated cost.

b. The Recipient may not communicate with any prospective Sub-Recipient with the intent of entering into a Lower Tier Agreement without receiving the prior written approval of the OTAO.

c. Lower Tier Agreements are subject to the review of the OTAO and may not be executed or modified by the Recipient until the Recipient has received the written approval of the OTAO.

4. Flow Down of Terms

Lower Tier Agreements must include the following Agreement terms, suitably modified to identify the Parties:

Paragraphs G, H, I, J, and L of Article V: Obligation and Payment

Article VI: Disputes

Article VII: Patent Rights

Article VIII: Data Rights, Participant-Derived Resources, Deliverables

Article IX: Data and Information Sharing

Article XI: Foreign Access to Technology

Article XIV: Applicable Statutes and Regulations

5. General

a. The Recipient shall give the OTAO immediate written notice of any action or suit filed and prompt notice of any claim made against the Recipient by any Sub-OT Recipient that, in the opinion of the Recipient, may result in litigation related in any way to this Agreement.

b. No funds awarded under this Agreement may be used by the Recipient to pay for costs associated with the management or administration of Lower Tier Agreements unless the Recipient has received the prior written approval of the OTAO.

c. Neither the approval nor the non-approval of a Lower Tier Agreement shall relieve the Recipient of responsibility to comply with the terms of this Agreement and perform work pursuant to the SOM.

E. Extending the Term The Parties may extend, by mutual written agreement, the term of this Agreement if research opportunities or the goals or objectives of the project are within the scope set forth in Article I reasonably warrant. Any extension shall be formalized through revision of the Agreement by the OTAO and the Recipient Business Official (RBO) and shall be subject to the availability of funds.

F. No Cost Extension For OT awards, any project period extension beyond the initial project period requires NIH prior approval. The request should include a description of the project activities that require support during the extension and a statement about the funds available to support the extension.

G. Changing the Term Changes to the terms and conditions are negotiated between the OTAO and the RBO.

H. Prior Approval Any prior approval request (e.g., changes to key personnel/partners as noted on the award, changes in human and animal subjects requiring prior approval) must be submitted in writing to the assigned OTAO, OTAS, and OTPO no later than thirty (30) days before the proposed change.

A request by a Sub-recipient will be addressed in writing to the prime Recipient. NIH prior written approval may be required before a Recipient makes certain modifications or undertakes activities.

All costs requested must be allocable, necessary, reasonable, and realistically reflect the approved project activities. Potential indicators of significant changes include, but are not limited to the following:

● Changes that would impact the timeline and/or scope of work to be completed

● Changes in the scope of work conducted by the award Recipient

● Changes in the approved facilities/administrative and/or indirect cost rate

Actions Requiring Prior Approval

● Deviation from the award terms and conditions including restriction removals

● Changes in key personnel

● Changes in key partnering organizations/Sub-recipients

● Changes that would impact the approved IRB

● Transfer of legal and administrative responsibility from one legal entity to another

● Additional time and/or funding

I. The System for Award Management (SAM) All Recipients must register in the System for Award Management (SAM) (https://sam.gov) and maintain an active registration with current information at all times while it has an award with NIH. SAM is the primary registrant database for the federal government and is the repository into which an entity must provide information required for the conduct of business.

J. The Notice of Award (NoA) NIH notifies the Recipient via e-mail when an award has been issued. In order to allow for the e-mail notification of the Notice of Award (NoA), the Recipient must register a valid e-mail address (in the NoA e-mail field) in the eRA Commons Institutional Profile once the initial eRA Commons registration process is complete. It is the responsibility of the Recipient to maintain a current and accurate e-mail address for official award notices. Recipients that do not maintain a current NoA notification e-mail address will be responsible for accessing these notices via the eRA Commons.

ARTICLE III. MANAGEMENT OF THE PROJECT

The Recipient shall be responsible for the overall management of the project, and technical planning and execution shall remain with the Recipient. The NIH OTAO, in consultation with the NIH OTPO, shall provide recommendations for project developments and technical collaboration and be responsible for the review and verification of the completion of milestone objectives and deliverables.

A. Modifications

1. As a result of interactions with the Recipient or at any time during the term of the Agreement, progress or results may indicate that a change in the Statement of Objectives and Milestones (SOM) would be beneficial to program objectives.

Recommendations to modify the SOM may be initiated by either Party. The initiating Party will document in writing and submit to the other Party its recommendations for modifying the SOM, including justifications to support the change. The NIH OTAO and the RBO shall approve any Agreement modification on a bilateral basis.

2. The NIH is not obligated to pay for additional or revised future work to be performed until the SOM is formally revised by the NIH OTAO and made part of this Agreement.

3. The NIH OTPO shall be responsible for the review and verification of any recommendations to revise or otherwise modify the SOM, prospective work, or other proposed changes to the terms and conditions of this Agreement.

4. The NIH OTAO will be responsible for documenting, communicating, and securing any necessary NIH approvals related to modifications to this Agreement.

B. Monitoring The Recipient is responsible for managing the day-to-day operations of Agreement activities using their established controls and policies. The NIH OTPO will monitor and identify potential problems and areas where technical assistance might be necessary. This monitoring is accomplished through review of reports provided pursuant to the SOM.

C. Management Systems and Procedures

The Recipient must have in use clearly delineated roles and responsibilities for its organization’s staff, both programmatic and administrative; written policies and procedures; training;

management controls and other internal controls; performance assessment; administrative simplifications; and information sharing. The Recipient may use its existing systems to manage Agreement funds and activities, provided that policies and procedures are consistently applied across its business functions.

ARTICLE IV: AGREEMENT ADMINISTRATION

The NIH will actively engage with Recipients to achieve the All of Us Research Program’s goals.

Each Party may change its representatives named in this Article by written notification to the other Party. The NIH will affect the change as stated in this Agreement.

Unless otherwise provided in this Agreement, approvals are obtained and changes may be made only by the NIH OTAO. Administrative and programmatic matters under this Agreement shall be referred to the following representatives of the Parties:

A. NIH Points of Contact

Other Transactions Agreements Officer (OTAO) [Name] [Contact Information]

Other Transactions Agreements Specialist (OTAS)

Other Transactions Program Official (OTPO)

B. Recipient Points of Contact

Recipient Business Official (RBO)

[Title]

Principal Investigator (PI)/Program Director (PD)

[Title]

All official communications must be sent from the Recipient Business Official (RBO), and at a minimum must include the OTAO, OTAS, OTPO and [INSERT AMB TEAM SPECIFIC EMAIL

ADDRESS].

Each Party may change its representatives named in this Article by written notification to the other Party. The NIH will affect the change as stated in Article III, Paragraph A.

ARTICLE V: OBLIGATION AND PAYMENT

A. Obligation The OT award provides funds for the budget period as appropriate for the negotiated and agreed upon work. Subsequent funding periods represent projections of future funding levels contingent on the availability of funds, achievement of agreed upon activities, and continued alignment with programmatic goals. Budget information, both obligated funds and funding projections, are detailed in the Statement of Budgetary Projections (SBP) (Attachment 2).

The NIH’s liability to make payments to the Recipient is limited to only those funds obligated under the Agreement or by modification to the Agreement and is subject to availability of funds. NIH may obligate funds to the Agreement incrementally. If modification becomes necessary in performance of this Agreement, the NIH OTAO and the RBO shall execute a revised

SOM.

B. Payment The Payment Management System (PMS) is a centralized payment and cash management system, operated by the Department of Health and Human Services (HHS) Program Support Center (PSC). Agreement payments by the PMS may be made by one of several advance payment methods, including SMARTLINK II/ACH, cash request, or by cash request on a reimbursement basis. Payments under this Agreement will be made upon completion of approved project milestones or as costs are incurred. Recipients must ensure PMS payments are drawn timely and that payments are no more than 60 calendar days in arrear. These requirements are intended to minimize the time elapsing between the transfer of funds from the Federal Government and disbursement to the Recipient.

Advances made by Recipients to third parties under the Agreement must conform to substantially the same standards of timing and amount that govern advances to the Recipient.

Operational guidance for the Recipient is provided through training from the DHHS PSC.

Inquiries regarding drawdown request, cash management rules should be directed to the HHS PSC (https://www.psc.gov/).

1. SMARTLINK II/ACH

The SMARTLINK II/ACH method of advance payment makes direct deposit of funds to a Recipient’s bank account and requires Recipients to have Internet access to submit a request for funds to PMS. SMARTLINK II/ACH provides funds the day following the request with direct deposit using the Federal Reserve Bank’s (Richmond, Virginia) ACH process.

2. Cash Request

Recipients not eligible for an unrestricted advance of funds by SMARTLINK II/ACH must submit a cash request, usually monthly. The cash request may be on either an advance or reimbursement basis. If the cash request is for an advance payment, the Recipient may request funds from PMS monthly on the basis of expected disbursements during the succeeding month and the amount of federal funds already on hand. A request for reimbursement may be submitted more often, if authorized. For timely receipt of cash, the Recipient must submit the request through the OTAO early enough for it to be forwarded to PMS at least two weeks before the cash is needed. The PMS makes payment to the Recipient electronically through the ACH process upon receipt of the approved payment request.

C. Interest Earned on Advances Recipients receiving advance payments must maintain those advanced funds in an interest-bearing account and promptly return any funds not spent within three (3) business days. Interest earned on federal advance payments deposited in interest-bearing accounts must be remitted annually to the Department of Health and Human Services, Payment Management System, 11400 Rockville Pike Rockwall I, Suite 700, Rockville, MD 20852. Interest amounts up to $500 per year may be retained by the Recipient for administrative expenses.

D. Limitation of Funds In no case shall the NIH’s financial liability exceed the amount obligated under this Agreement.

E. Appropriation Legislative Mandates This award must comply with NIH fiscal appropriation legislative mandates.

F. Close out of Fixed Year Appropriations Amounts All Federal agencies are required by 31 U.S.C. 1552(a) to close fixed year appropriation accounts and cancel any remaining balances by September 30 of the fifth fiscal year after the year of availability. In order for the NIH to meet its obligation to close these accounts and cancel any remaining balances by September 30, Recipients must report total disbursements no later than

June 30 of the fifth fiscal year after the year of availability. At the end of five years, the funds are canceled and returned to the Treasury.

G. Retention of Financial Records

The Recipient shall maintain adequate records to account for all funding under this

1. The OTAO or designee shall have direct access to sufficient records and information of the Recipient, to ensure full accountability for all funding under this Agreement. Such audit, examination, or access shall be performed during business hours on business days upon prior written notice and shall be subject to the security requirements of the audited party.

2. The Recipient’s relevant financial records are subject to examination or audit on behalf of the NIH or by the NIH for a period not to exceed three (3) years. For OT awards, the 3-year record retention period will be calculated from the date that the final Federal Financial Report (FFR) for the entire funding segment is submitted. If any litigation, claim, financial management review, or audit is started before the expiration of the 3-year period, the records must be retained until all litigation, claims, or audit findings involving the records have been resolved and final action taken. These record retention policies apply to both paper and electronic storage of applicable information, including electronic storage of faxes, copies of paper documents, images, and other electronic media.

H. Undisbursed Obligated Balances and Actual Expenditures Using the principle of “first-in, first-out” undisbursed obligated funds carried over into a new budget period must be used before newly awarded funds.

I. Audit For purposes of this Agreement, the Recipient is deemed subject to the audit requirements of OMB 2 CFR 200, Subpart F-Audit Requirements, as implemented by DHHS 45 CFR Subpart F.

J. Financial Management System Standards The Recipient must have and maintain an established accounting system which complies with Generally Accepted Accounting Principles (GAAP) and accounting and internal control systems must provide for appropriate monitoring of award accounts to ensure that obligations and expenditures are reasonable, allocable, and allowable. In addition, the systems must be able to identify unobligated balances, accelerated expenditures, inappropriate cost transfers, and other inappropriate obligations and expenditures of funds, and Recipient must notify the NIH OTAO when problems are identified. The Recipient’s failure to establish adequate control systems constitutes a material breach of this Agreement and may result in the exercise of available enforcement remedies.

K. Procurement System Standards and Requirements Recipients may acquire a variety of goods or services in connection with an OT award-supported project, ranging from those that are routinely purchased goods or services to those that involve substantive programmatic work. Recipients must acquire goods and services under OT awards in compliance with their established policies and procedures and for the negotiated purposes outlined in the SOM.

L. Cost Principles In general, this Agreement is subject to reimbursement of actual, allowable costs incurred and must align with generally accepted and established federal cost principles for the entity receiving funding (academic, non-profit, for-profit, etc.). The cost principles are set forth in 2 CFR Part 200, Subpart E, 45 CFR Part 75, Subpart E, and Appendix IX (Hospital Cost Principles) to Part 200 and Part 45. Commercial organizations are subject to the cost principles located at 48 CFR Part 31.2 Federal Acquisition Regulation.

Recipients may use their own accounting systems, policies, and procedures to implement the cost principle requirements as long as they meet the Generally Accepted Accounting Principles (GAAP) standards for financial management systems.

M. Human Subjects Research The Recipient cannot draw down funds from the payment system and no obligations may be made against Federal funds for research involving human subjects (as defined by 45 CFR part

46) https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html supported by this Agreement for any period not covered by both an Office for Human Research Protections (OHRP) https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/fwas/fwa-protection-of-human-subjec ct/index.html approved Federal Wide Assurance and, as required by 45 CFR Part 46 https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/fwas/fwa-protection-of-human-subjec ct/index.html, approval from an Institutional Review Board (IRB). This Agreement requires the institution to ensure that all personnel and partners who engage in human subjects research have completed education on the protection of human subjects. Any individual involved in the design or conduct of the study must satisfy this requirement prior to participating in the project.

The Recipient bears the ultimate responsibility for safeguarding the rights and welfare of human subjects, as stipulated in 45 CFR Part 46. Failure to comply will result in the immediate suspension and/or termination of this Agreement.

N. Animal Research The Recipient cannot draw down funds from the payment system and no obligations may be made against Federal funds for research involving animals by any site engaged in such research for any period in which the site is not in compliance with the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (https://olaw.nih.gov/policies-laws/phs-policy.htm). Failure to comply will result in the immediate suspension and/or termination of this Agreement.

O. Unallowable Costs Direct charges for meals/food/beverages, pre-award costs, promotional items, entertainment, and alteration/construction costs are unallowable charges to this project, without the express written prior approval of the OTAO. Recipients shall provide the request in writing at least 30 calendar days in advance to the OTAO.

P. Other Support Commitment overlap occurs when any project-supported personnel (including support staff and key personnel) have time commitments exceeding 100 percent, regardless of how the effort/salary is being supported or funded. Therefore, no individual may reflect over 100 percent in the total effort he/she spends on research and other organizational responsibilities.

An investigator may be affiliated with several organizations; however, the combination of appointments cannot exceed 100 percent. Reporting zero percent of effort is not acceptable.

The award organization is responsible for ensuring no individual supported by this award exceeds 100 percent committed effort.

Q. Recovery of Funds NIH may identify and administratively recover funds paid to a Recipient at any time during the life cycle of an OT award. Debts may result from cost disallowances, unobligated balances, unpaid share of any required matching or cost-sharing, funds in the account that exceed the final amount determined to be allowable, or other circumstances.

R. Debt Collection The debt collection process is governed by the Federal Claims Collection Act, as amended (Public Law [P.L.] 89-508, 80 Stat. 308, July 19, 1966); the Federal Debt Collection Act of 1982 (P.L. 97-365, 96 Stat. 1749, October 25, 1982); the Debt Collection Improvement Act (P. L.

104-134, 110 Stat. 1321, April 26, 1996); and the Federal Claims Collection Standards (31 CFR Parts 900-904), which are implemented for DHHS in 45 CFR 30. NIH is required to collect debts due to the Federal Government and, except where prohibited by law, to charge interest on all delinquent debts owed to NIH by Recipients.

ARTICLE VI: 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 Any disagreement, claim or dispute between NIH and the Recipient 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.

Whenever disputes, disagreements, or misunderstandings arise, the Parties shall attempt to resolve the issue(s) involved by discussion and mutual agreement as soon as practicable. In no event shall a dispute, disagreement or misunderstanding which arose more than three (3) months prior to the notification made under this Article constitute the basis for relief under this Article.

Failing resolution by mutual agreement, the aggrieved Party shall document the dispute, disagreement or misunderstanding by notifying the other Party (through the NIH OTAO or the RBO, as the case may be) in writing documenting the relevant facts, identifying unresolved issues, specifying the clarification or remedy sought. Within ten (10) business days after providing notice to the other Party, the aggrieved Party may, in writing, request a joint decision by the All of Us Director of Awards Management appointed by the NIH, and a senior executive appointed by the Recipient. 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 All of Us Director of Awards Management appointed by the NIH, and a senior executive appointed by the Recipient, 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.

In the absence of a joint decision, the matter will be elevated to the All of Us Chief Financial and Management Officer for further review. The All of Us Chief Financial and Management Officer may elect to conduct this review personally or through a designee or jointly with a senior executive appointed by the Recipient. Following the review, the All of Us Chief Financial and Management Officer or designee will resolve the issue(s) and notify the Parties in writing. Such resolution is not subject to further administrative review by the All of Us Chief Financial and Management Officer, whose decision to the extent permitted by law, shall be final and binding.

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 NIH funding disbursed as of the time the dispute arises. Subject to applicable law in no event shall either party be liable for claims for consequential, punitive, special or incidental damages, claims for lost profits, or other indirect damages.

ARTICLE VII: PATENT RIGHTS

A. Allocation of Principal Rights Unless the Recipient notified NIH that the Recipient does not intend to retain title, the Recipient shall retain the entire right, title, and interest throughout the world to each Subject Invention consistent with the provisions of this Article and 35 U.S.C §§ 200-212 and associated regulations.

With respect to any Subject Invention in which the Recipient retains title, the Government shall have a nonexclusive, nontransferable, irrevocable, royalty-free, paid-up license to practice or have practiced on behalf of the United States the Subject Invention throughout the world.

With respect to any Data the Recipient will own the Data developed under this award, subject to the Government’s royalty-free, nonexclusive, irrevocable right to use, disclose, reproduce, post, link to, prepare derivative works, distribute copies to the public, and perform publicly and display publicly, in any manner and for any purpose, and to have or permit others to do so anywhere in the world. In addition, Know-How developed under this Agreement will remain the property of the Recipient, who may freely use them for its own commercial purposes, subject to a nonexclusive, nontransferable, irrevocable, royalty-free, paid-up license to the Government to practice, or have practiced for or on its behalf, the Know-How throughout the world.

B. Invention Disclosure, Election of Title, and Filing of Patent Application The Recipient shall disclose each Subject Invention to NIH within four (4) months after the inventor discloses it in writing to their company personnel responsible for patent matters. The disclosure to NIH shall be in the form of a written report and shall identify the Agreement and circumstances under which the Invention was made and the identity of the inventor(s). It shall be sufficiently complete in technical detail to convey a clear understanding, to the extent known at the time of the disclosure, of the nature, purpose, operation, and the physical, chemical, biological, or electrical characteristics of the Invention. The disclosure shall also identify any publication, sale, or public use of the invention and whether a manuscript describing the Invention has been submitted and/or accepted for publication at the time of disclosure.

If the Recipient determines that it does not intend to retain title to any such Invention, the Recipient shall notify NIH, in writing within six (6) months of disclosure. However, in any case where publication, sale, or public use has initiated the one-year statutory period wherein valid patent protection can still be obtained in the United States, the period for such notice may be shortened by NIH to a date that is no more than sixty (60) calendar days prior to the end of the statutory period.

The Recipient shall file its initial patent application on a Subject Invention to which it elects to retain title within one (1) year after election of title or, if earlier, prior to the end of the statutory period wherein valid patent protection can be obtained in the United States after a publication, or sale, or public use. The Recipient may elect to file patent applications in additional countries, including the European Patent Office and the Patent Cooperation Treaty, within either ten (10) months of the corresponding initial patent application or six (6) months from the date permission is granted by the Commissioner for Patents to file foreign patent applications, where such filing has been prohibited by a Secrecy Order.

The Recipient shall notify NIH of any decisions not to continue the prosecution of a patent application, pay maintenance fees, or defend in a reexamination or opposition proceedings 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.

Requests for extension of the time for disclosure election, and filing under Article VII, may be granted at NIH’s discretion after considering the circumstances of the Recipient and the overall effect of the extension.

The Recipient shall submit to NIH annual listings of Subject Inventions. At the completion of the Agreement, the Recipient shall submit a comprehensive listing of all subject inventions identified during the course of the Agreement and the current status of each.

C. Conditions When the NIH May Obtain Title Upon NIH’s written request, the Recipient shall convey title to any Subject Invention to NIH under any of the following conditions:

● If the Recipient fails to disclose or elects not to retain title to the Subject Invention within the times specified in this Article;

● In those countries in which the Recipient fails to file patent applications within the times specified in this Article; however, if the Recipient has filed a patent application in a country after the times specified in this Article, but prior to its receipt of the written request by NIH, the Recipient shall continue to retain title in that country; or

● In any country in which the Recipient decides not to continue the prosecution of any application for, to pay the maintenance fees on, or defend in reexamination or opposition proceedings on, a patent on a Subject Invention.

D. Minimum Rights to the Recipient and Protection of the Recipient’s Right to File The Recipient shall retain a nonexclusive, royalty-free, commercial license throughout the world in each Subject Invention to which the NIH obtains title, except if the Recipient fails to disclose the Subject Invention within the times specified in this Article. The Recipient’s license extends to its domestic subsidiaries and affiliates, if any, and includes the right to grant licenses of the same scope to the extent that the Recipient was legally obligated to do so at the time the Agreement was awarded. Any extension of the Recipient’s license to its subsidiaries and affiliates that are based outside the United States must comply with all export control laws and other federal laws that may apply. The license is transferable only with the approval of NIH, except when transferred to the successor of that part of the business to which the Subject Invention pertains. NIH approval for license transfer shall not be unreasonably withheld.

The Recipient’s domestic license may be revoked or modified by NIH to the extent necessary to achieve expeditious practical application of the Subject Invention pursuant to an application for an exclusive license submitted consistent with appropriate provisions at 37 C.F.R. Part 404.

This license shall not be revoked in that field of use or the geographical areas in which the Recipient has achieved practical application and continues to make the benefits of the Subject Invention reasonably accessible to the public. The license in any foreign country may be revoked or modified at the discretion of NIH to the extent the Recipient, its licensees, or the subsidiaries or affiliates have failed to achieve practical application in that foreign country.

Before revocation or modification of the license, NIH shall furnish the Recipient a written notice of its intention to revoke or modify the license, and the Recipient shall be allowed thirty (30) calendar days (or such other time as may be authorized for good cause shown) after the notice to show cause why the license should not be revoked or modified.

E. Action to Protect the NIH’s Interest The Recipient agrees to execute or to have executed and promptly deliver to NIH all instruments necessary to (i) establish or confirm the rights the NIH has throughout the world in those Subject Inventions to which the Recipient elects to retain title, and (ii) convey title to NIH when requested under this Article and to enable the NIH to obtain patent protection throughout the world in that Subject Invention.

The Recipient agrees to require by written agreement with its employees, other than clerical and non- technical employees, to disclose promptly in writing to personnel identified as responsible for the administration of patent matters and in a format suggested by the Recipient each Subject Invention made under this Agreement in order that the Recipient can comply with the disclosure provisions of this Article.