ROA OTA-22-006 APPENDIX A_Terms and Conditions Template.pdf

OTA

-22-006 Appendix A

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OTHER TRANSACTIONS AGREEMENT

BETWEEN

NAME OF ORGANIZATION

Full Address of Organiza�on

AND

NATIONAL INSTITUTES OF HEALTH

ALL OF US RESEARCH PROGRAM

6710B Rockledge Drive, Bethesda, Maryland 20817

CONCERNING

<INSERT RESEARCH AND DEVELOPMENT TITLE>

Agreement No.: #OT2OD######-01 Total Amount of the Agreement: $ ###,###.## Total Period of Agreement: ##/##/#### to ##/##/#### Current Budget Period: ##/##/#### to ##/##/####

Total Funds Obligated by Date:

XX/XX/XXXX $ ##### CAN Number(s): XXXXXXXXXXX XX/XX/XXXX $ ##### CAN Number(s): XXXXXXXXXXX XX/XX/XXXX $ ##### CAN Number(s): XXXXXXXXXXX

DATE: XX/XX/XXXX

Authority: Sec�on 402(n) of the Public Health Service Act, 42 U.S.C. 282(n).

This Other Transac�ons Agreement (hereina�er, Agreement) is entered into between the United States of America, hereina�er called the Government, represented by the Na�onal Ins�tute of Health (NIH) and the <INSERT NAME OF ORGANIZATION> pursuant to and under U.S. Federal law.

OT# OD######-01

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FOR <INSERT NAME OF ORGANIZATION>

Authorized Recipient Business Official (RBO)

**insert Recipient Business Official Name** **insert Recipient Business Official Title**

FOR THE UNITED STATES OF AMERICA, NATIONAL INSTITUTE OF HEALTH, OFFICE OF THE DIRECTOR, ALL OF US

RESEARCH PROGRAM

Other Transac�ons Agreements Officer (OTAO)

**insert OTAO name** **insert OTAO �tle**

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Contents

ORDER OF PRECEDENCE 6

EXECUTION 6

ARTICLE I: SCOPE OF THE AGREEMENT 7

A. Background of the All of Us Research Program 7 B. Defini�ons 7 C. Scope 14

ARTICLE II: TERM 16

A. Term of this Agreement 16 B. Termina�on Provisions 16 C. Extending the Term 16 D. Flow Down of Terms 16

ARTICLE III: MANAGEMENT OF THE PROJECT 18

A. Risk Mi�ga�on and Purpose of JOC (Joint Oversight Commi�ee): 18 B. Project Mee�ngs 18

1. Project Teleconferences: 18

2. Other Mee�ngs: 18

3. In Process Review Mee�ng (IPR): 19

C. Document Review 19 D. Management Systems, Procedures and Program Structure 19 E. Property Management System Standards 19 F. Procurement System Standards and Requirements 20 G. Program Plan 20 H. Overall Program Plan Annual Review 20 I. Modifica�ons 20 J. Monitoring 21 K. Programma�c, Mee�ng, and Financial Repor�ng Requirements 21

ARTICLE IV: AGREEMENT ADMINISTRATION/ROLES AND RESPONSIBILITIES 22

A. Government Points of Contact: 22 B. Recipient Points of Contact 22 C. Key Partners/Stakeholders 23 D. Key Personnel/PI(s) 23 E. Other Project-Support Personnel Restric�ons 24 F. Roles and Responsibili�es 24

Recipient Business Official (RBO) 24 Principal Inves�gator (PI) 25 Other Transac�ons Agreements Officer (OTAO) 25

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Other Transac�ons Agreements Specialist (OTAS) 25 Other Transac�ons Technical Representa�ve (OTTR) 26 Other Transac�ons Program Official (OTPO) 26 Other Transac�ons Scien�fic Program Director 26

ARTICLE V: OBLIGATION, PAYMENT AND COST CONSIDERATIONS 27

A. Obliga�on 27 B. Funding 27 C. Payments 27 D. Interest Earned on Advances 27 E. Lower Tier Agreement Costs 28 F. Limita�on of Funds 28 G. Salary Cap: 28 H. Unobligated Balances and Actual Expenditures 28 I. Cost Principles 28 J. Direct Costs and Indirect Costs/Facili�es and Administra�ve Costs(F&A) 28 K. Appropria�on Mandates 29 L. Travel Approval 29 M. Financial Management System Standards; Financial Records and Repor�ng 29

Financial Management System Standards 29 Financial Records and Reports 29

N. No�fica�on of Claim Against Recipient: 30 O. Lower Tier Agreement Costs: 30 P. Unallowable Costs: 30

Pre-award costs 31 Q. Prior Approval Requirements: 31 R. Audit Requirements: 31

Addi�onal program-specific audit elec�ons 32 S. Close out Procedures 32

Close out of Fixed Year Appropria�ons Accounts 33 Record Reten�on and Access 33

T. FedRAMP, Cloud Security, Opera�ons, and Compliance Direct Costs 33

ARTICLE VI: DISPUTES 34

A. General 34 B. Dispute Resolu�on Procedures 34 C. Limita�on of Damages 34 D. 3rd Party Oversight and Evalua�on 34

ARTICLE VII: PATENT RIGHTS. 35

A. Alloca�on of Principal Rights 35

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B. Inven�on Disclosure, Elec�on of Title, and Filing of Patent Applica�on 35 C. Condi�ons When the NIH May Obtain Title 36 D. Minimum Rights to the Recipient and Protec�on of the Recipient’s Right to File 36 E. Ac�on to Protect the NIH’s Interest 37 F. Repor�ng on U�liza�on of Subject Inven�ons 37 G. March-in Rights 37

ARTICLE VIII: DATA RIGHTS 39

Data Sharing Policy 39 A. Alloca�on of Principal Rights 39 B. Marking of Data 39 C. Termina�on Data Rights 40 D. Background Data 40 E. Basis of Asser�on 40 F. Asserted Rights Category 40 G. Iden�fica�on and Disposi�on of Data 41

Marking of Data 41 Lower Tier Awards 41

H. Genomic Data Sharing (GDS) Policy 41

ARTICLE IX: FOREIGN AFFILIATION 43

ARTICLE X: CIVIL RIGHTS ACT 44

ARTICLE XI: SPECIAL CLAUSES 45

A. Material Transfer Agreement 45 B. A�ribu�on Statement 45 C. NIH Product Owners 45 D. All of Us Research Program Website 45 E. Preference for American Industry 45 F. External Communica�ons 46 G. Public Release or Dissemina�on of Informa�on 46

Review of Press Releases 47 H. Risk Assessment 47 I. Cer�ficates of Confiden�ality 47 J. Lobbying Prohibi�on 47 K. Promo�on or Legaliza�on of Controlled Substances 48 L. Dissemina�on of False or Deliberately Misleading Informa�on 48 M. Restric�on of Pornography on Computer Networks 48 N. USA Patriot Act 49 O. Rehabilita�on Act of 1973 49

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P. Research Involving Recombinant or Synthe�c Nucleic Acid Molecules 49 Q. Select Agents 49 R. Federal Informa�on Security Management Act (FISMA) 50 S. All of Us Research Program Data Security Framework 50

ATTACHMENT 1: REPORT REQUIREMENTS 54

A. MONTHLY REPORT 54

B. ANNUAL PROGRAM PLAN DOCUMENT 57

C. AD HOC/SPECIAL TECHNICAL REPORTS 57

D. FINAL REPORT 57

Execu�ve Summary 57

ATTACHMENT 2: TASK DESCRIPTION DOCUMENT (SOW/SOO) AND MILESTONES 59

ATTACHMENT 3: FUNDING SCHEDULE AND STATEMENT OF BUDGETARY PROJECTIONS 60

A. PROJECTED PROGRAM FUNDING 60

B. STATEMENT OF BUDGETARY PROJECTIONS 60

ORDER OF PRECEDENCE

In the event of any inconsistency between the terms of this Agreement and language set forth in the A�achments, the inconsistency shall be resolved by giving precedence in the following order: (1) The Agreement, and (2) all A�achments to the Agreement.

EXECUTION

This Agreement cons�tutes the en�re agreement of the Par�es and supersedes all prior and contemporaneous agreements, understandings, nego�a�ons, and discussions among the Par�es, whether oral or wri�en, with respect to the subject ma�er hereof. This Agreement may be revised only by wri�en consent of the Recipient and the NIH Other Transac�ons Agreements Officer (OTAO). This Agreement, or modifica�ons thereto, may be executed in counterparts each of which shall be deemed as original, but all of which taken together shall cons�tute one and the same instrument.

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ARTICLE I: SCOPE OF THE AGREEMENT

A. Background of the All of Us Research Program

The All of Us Research Program is working to improve health care through research. Unlike research studies that focus on one disease or group of people, All of Us is building a diverse database that can inform thousands of studies on a variety of health condi�ons. This creates more opportuni�es to:

● Know the risk factors for certain diseases

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

● Connect people with the right clinical studies for their needs

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

K nowledge gained from observa�onal cohort studies has drama�cally advanced the preven�on and treatment of diseases. Many of these cohorts, however, are small, lack diversity, or do not provide comprehensive phenotype data. The All of Us Research Program has begun enrollment of a diverse group of at least 1 million persons in the United States to accelerate biomedical research and improve health. The program aims to make the research results accessible to par�cipants, and it is developing new approaches to generate, access, and make data broadly available to approved researchers. Elements of the program protocol include health ques�onnaires, electronic health records (EHRs), physical measurements, the use of digital health technology, and the collec�on and analysis of biospecimens.

B. Defini�ons

ACS (Award Capability Statement): Document used to highlight key personnel to include PIs qualifica�ons for a specific role in the proposed project. This is used interchangeably with bio sketch.

Agreement: The body of this Other Transac�ons Agreement and its A�achments, which are expressly incorporated in and made a part of the Agreement.

All of Us Research Program : Previously known as the Precision Medicine Ini�a�ve Cohort Program is a research program that aims to make advances in tailoring medical care to the individual. The project aims to collect gene�c and health data from one million volunteers.

Annual Program Plan: A detailed schedule of research ac�vi�es that documents the Recipients ability to meet specific performance objec�ves and describes the payable milestones (as applicable)

ATO (Authoriza�on to Operate): The official management decision given by a senior organiza�onal official to authorize opera�on of an informa�on system and to explicitly accept the risk to organiza�onal opera�ons (including mission, func�ons, image, or reputa�on), organiza�onal assets, individuals, other organiza�ons, and the Na�on based on the implementa�on of an agreed-upon set of security controls.

Recipient Business Official (RBO): Individual responsible for the legal commitment by the Recipient and for the administra�ve and financial repor�ng compliance with terms and condi�ons of this Agreement. All official correspondence must be submi�ed by the RBO.

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Broad Agency Announcement ( BAA ): A method used by the NIH to solicit proposals for research and development projects by “solici�ng for solu�ons ” . Under a BAA, the NIH may make an award and any award instrument it is authorized to use including but not limited to a FAR based contract, grant, coopera�ve agreement, or other transac�ons.

CAN (Common Accoun�ng Number): Are used to obligate the OT Award and to establish reimbursable authority for the Recipient IC. Note: IC (Ins�tutes and Centers), are Offices within the Office of the Director, NIH.

Communica�ons Plan: Provides a roadmap for ge�ng the message delivered to All of Us Research Program stakeholders that is clear, specific and has measurable results. It includes defining the communica�on objec�ves, key audiences, and channels of communica�on. It also provides a �meline for comple�on of the steps for developing transla�ons of materials into other languages and sharing the communica�ons as well as who is responsible for and needs to be looped in on the development of the communica�ons. This is used interchangeably with Communica�ons Strategy Plan.

Data: Recorded informa�on, regardless of form or method of recording, which includes but is not limited to, technical data, so�ware, mask works and trade secrets. The term does not include financial, administra�ve, cost, pricing or management informa�on and does not include subject inven�ons. The term does not include financial, administra�ve, cost, pricing or management informa�on and does not include subject inven�ons, included in Ar�cle VII.

Delega�on of Authority: The specific, formal deputa�on, assignment, or commitment of a legal power or right to take certain ac�ons and to make certain decisions having legal significance. Such delega�ons must be stated in wri�ng by the official authorized, called the OTAO, to delegate the authority.

Direct Cost: The costs that can be iden�fied specifically with a par�cular sponsored project, an instruc�onal ac�vity, or any other ins�tu�onal ac�vity, or that can be directly assigned to such ac�vi�es rela�vely easily with a high degree of accuracy.

Engagement Plan: Defines and documents the approach and ac�ons that will be taken to increase input and support and minimize the nega�ve impacts of external stakeholders throughout the life of the project. The plan must list the stakeholders with which the project will engage, priori�ze which stakeholders will have the most influence on the project, iden�fy at which stage each stakeholder will be involved in, and the �melines by which their feedback is needed.

Federal Financial Report (FFR) – The form SF (Special Form) 425 is a statement of expenditures associated with the award electronically to the Payment Management System (PMS) at closeout of award.

Fee/Profit: An amount, in addi�on to actual, allowable costs, paid to an organiza�on providing goods or services consistent with normal commercial prac�ce. This payment also is referred to as profit.

First in-First-Out Unobligated Funds: Unobligated balances that expire may stay within an account for up to five addi�onal years and can be used only to cover upward adjustments of prior-year obliga�ons. Oldest funds will be used first before moving to newer funds.

FISMA: The Federal Informa�on Security Management Act is legisla�on that defines a framework of guidelines and security standards to protect government informa�on and opera�ons. This risk management framework was signed into law as part of the Electronic Government.

https://policymanual.nih.gov/6035

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Food and Drug Administra�on (FDA): A government agency established under the Federal Food and Drugs Act.

The agency is separated into divisions that oversee food, drugs, cosme�cs, animal food, dietary supplements, medical devices, biological goods, and blood products. The All of Us Research Program primarily collaborates with them over their associa�on with Gene�c Materials, such as blood and saliva.

Foreign Firm or Ins�tu�on: A firm or ins�tu�on organized or exis�ng 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, ins�tu�ons or business organiza�ons which are owned or substan�ally controlled by foreign governments, firms, ins�tu�ons, or individuals.

Government: The United States of America, as represented by NIH.

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.

HIPAA: Health Insurance Portability and Accountability Act, a 1996 Federal law that restricts access to individuals' private medical informa�on

Indirect Cost: Any cost that can’t be directly iden�fied with a single, final cost objec�ve, but is iden�fied with two or more final cost objec�ves or an intermediate cost objec�ve. For reasons of prac�cality, any direct cost of minor dollar amount may be treated as an indirect cost if the accoun�ng treatment is consistently applied to all cost objec�ves and the treatment produces substan�ally the same results as trea�ng the cost as a direct cost.

Intellectual Property (IP): The crea�ve works or ideas embodied in a form that can be shared or can enable others to recreate, emulate, or manufacture them. Intellectual property is protected by state and federal laws governing inven�ons, patents, trademarks, unfair compe��on, copyrights, trade secrets, data and Technical Data, the right of publicity, and new plant varie�es. Examples of intellectual property include inven�ons; patents;

copyrights; designs; know-how; business, technical, and research methods; and other types of intangible business assets such as goodwill and brand recogni�on.

Inven�on: Any inven�on or discovery which is or may be patentable or otherwise protectable under Title 35 of the United States Code. Anything conceived or first actually reduced to prac�ce in the performance of work under this Agreement.

Ins�tu�onal Review Board (IRB) Plan: Provides the process for iden�fying all aspects of a project that require review by the All of Us Research Program Ins�tu�onal Review Board (IRB). It also provides a �meline for development of the required materials for any IRB submission(s), review, and approval of the materials (including senior staff, policy, privacy, and security), and a proposed IRB submission date. IRB submission materials may include but are not limited to proposed changes to the Core Protocol, study proposal document, recruitment materials, communica�ons, data collec�on instruments (surveys, interview ques�ons), and consent forms.

Independent Research and Development (IR&D) Expenses: An expense used in accoun�ng for independent research and development costs that shall be allocated to final cost objec�ves on the same basis of alloca�on used for the General and Administra�ve (G&A) expense grouping of the profit center.

ISSO: The Informa�on System Security Officer (ISSO) serves as the principal advisor to the Informa�on System Owner (SO), Business Process Owner, and the Informa�on System Security Manager (ISSM) as applicable on all ma�ers, technical and otherwise, involving the security of an informa�on system. ISSOs are responsible for

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IT Security Plan: Provides a comprehensive assessment and/or evalua�on of informa�on system policies, technical / non-technical security components, documenta�on, supplemental safeguards, policies, and vulnerabili�es to determine project compliance with All of Us Research Program security standards. This may include the requirement for a formal declara�on of an informa�on system accredita�on or Authority to Operate

(ATO).

Joint Oversight Commi�ee (JOC): Comprised of 5 senior level members from Recipient (3 of which will be non-vo�ng), 2 senior level Government par�cipants, and the Other Transac�ons Agreements Officer (OTAO), Other Transac�ons Agreements Specialist (OTAS), and Other Transac�ons Technical Representa�ve (OTTR) who will a�end as non-vo�ng par�cipants

Key Personnel: Individuals who contribute to the scien�fic development or execu�on of a project in a substan�ve measurable way. The program director/principal inves�gator (PI) are always considered key personnel.

Know-How: All informa�on including, but not limited to discoveries, formulas, materials, inven�ons, processes, ideas, approaches, concepts, techniques, methods, so�ware, programs, documenta�on, procedures, firmware, hardware, technical data, specifica�ons, devices, apparatus, and machines.

Level of Effort (LOE): A support-type project ac�vity that must be done to support other work ac�vi�es or the en�re project effort. Recipients are required to devote and maintain a minimum level of effort to meet the requirements of the Agreement. Even though NIH does not have minimum effort requirements for principal inves�gators of OT Awards the All of Research Program requires that the total percentage for mul�ple PI’s effort total 100% and any PI's minimum is 10 percent of the total effort on the project.

Line Item Number (LIN): Line items serve two purposes, (1) they break the Agreement down by the commodi�es being procured (labor hours of services, funding for travel, quan�ty of product A, quan�ty of product B, etc.) and

(2) they provide for traceable accoun�ng classifica�on cita�ons. It is o�en driven by internal government accoun�ng requirements like fiscal years and appropria�ons that are o�en not visible to the outside observer.

Made : Relates to any inven�on means the concep�on or first actual reduc�on to prac�ce of such inven�on.

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Metrics: Aims to op�mize processes and deliver favorable outcomes. It provides a level of evidence of the level of achievement.

No�ce of Award (NOA): Abbreviated, system generated document, that references the official, legally binding Agreement. This document is signed (or the electronic equivalent of signature) by the Other Transac�ons Agreements Officer, no�fies the Recipient of their receipt of an Other Transac�on award, contains references to all terms and condi�ons, and includes federal funding limits and obliga�ons.

Nondisclosure Agreement: A legal contract in which the par�es involved agree to keep the informa�on included private. This type of contract creates a confiden�al rela�onship between the par�es and protects the confiden�al or proprietary informa�on outlined in the Agreement, as breaching a nondisclosure agreement generally subjects the party to severe civil penal�es.

Non-Federal En�ty: A state, local government, Indian tribe, ins�tu�on of higher educa�on, or nonprofit organiza�on that carries out a federal award as a Recipient or subRecipient of the Other Transac�on.

Obliga�on : The amounts for which the Recipient has made binding commitments for orders placed for services, contracts and subawards, and similar transac�ons during a funding period that will require payment during the same or a future period.

Opera�ons Plan: This plan describes the ongoing monitoring of project or applica�on usage and analy�cs, and the process for iden�fying and conduc�ng needed updates, modifica�ons, and required for All of Us applica�ons including but not limited to security updates and code maintenance, conduct of yearly applica�on audits, design and feature enhancements, performance monitoring. It should include how users will request modifica�ons and report problems. The plan should also define and quan�fy the workload and budget required for ongoing maintenance and updates

Other Transac�ons (OT) Agreements: The awards made pursuant to Other Transac�ons Authori�es are commonly referred to as Other Transac�ons or “Other Transac�ons Agreements.” An Other Transac�ons Agreement is a vehicle used by federal agencies for obtaining or advancing research and development or prototypes. There are statutes that authorize the award of transac�ons other than procurement contracts, grants, or coopera�ves agreements. Only those agencies that have been provided Other Transac�ons Authority may engage in other transac�ons.

Other Transac�ons Agreements Officer (OTAO): A warranted or cer�fied individual authorized to execute Other Transac�ons on behalf of the Government. An OTAO is responsible for legally commi�ng the government to an Other Transac�on; has the ability to enter into, administer, and terminate Other Transac�ons; and possess a level of responsibility, business acumen, and judgment that enables them to operate in a rela�vely unstructured environment.

Other Transac�ons Agreements Specialist (OTAS): Individual who serves as a delegate of the OTAO, assigned responsibility for the day-to-day management of Other Transac�ons Agreements .

Other Transac�ons Program Official (OTPO): The NIH Federal official responsible for the programma�c, scien�fic, and/or technical aspects of their assigned Other Transac�on projects.

https://grants.nih.gov/grants/glossary.htm#Obligation

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Other Transac�ons Scien�fic Director (OTSD): Iden�fied in the OT Agreement, the OTSD must have the appropriate scien�fic or technical background to provide programma�c input and exper�se, in close partnership with the Other Transac�ons Program Official and Other Transac�ons Agreements Officer. The OTSD typically serves under the direc�on of the program and is authorized to provide single voice technical direc�on to the Recipient on behalf of the government. In offering this direc�on, the OTSD will collaborate closely with colleagues to bring forward the knowledge and exper�se needed to meet strategic goals within the framework of the ini�a�ve governance.

Other Transac�ons Technical Representa�ve (OTTR): A designee of the Other Transac�ons Agreements Officer that provides day-to day programma�c oversight, working closely with the Other Transac�ons Agreements Officer, the assigned Other Transac�ons Agreements Specialist, and the Recipient.

Party: Includes the Government/NIH, or the Recipient, or both

Payment Management System ( PMS ): The HHS centralized grants payment system operated by the Division of Payment Management, Program Support Center. NIH Recipients of Other Transac�ons receive payments through this system.

Performance Base Milestones: Milestones �ed to financing payments based upon the achievement of specific, measurable events or accomplishments that are defined and valued in advance by the par�es to the award.

Period of Performance (PoP): The �me during which the Recipient may incur new obliga�ons to carry out the work authorized under the award.

Plans of Ac�on & Milestones (POA&Ms): A document that iden�fies tasks needing to be accomplished. It details resources required to accomplish the elements of the plan, any milestones in mee�ng the tasks, and scheduled comple�on dates for the milestones.

Prac�cal Applica�on: To manufacture, in the case of a composi�on of product; to prac�ce, 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 condi�ons as to establish that the inven�on is capable of being u�lized and that its benefits are, to the extent permi�ed by law or Government regula�ons, available to the public on reasonable terms.

Program: Research and development organiza�on, as set forth in Ar�cle I, paragraph C.

Principal Inves�gator (Pl): Individual designated by the Recipient to have the appropriate level of authority and responsibility to direct the day-to-day opera�ons of the project or program supported by the Other Transac�ons Agreement award. Note: This is used interchangeably with Program Director (PD).

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

Recipient: The en�ty responsible for the administra�ve, financial, and programma�c ac�vi�es described in the Agreement.

Repor�ng: An account given of a par�cular ma�er in the form of an official document or presenta�on. Reports may include but are not limited to financial data (e.g., expenses paid for with federal funds and cost sharing funds; milestone-based payments); compliance informa�on to ensure the Recipient is following the Other https://pms.psc.gov/

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Transac�ons Agreement and federal regula�ons; and project data highligh�ng progress and/or community impact (e.g., quan�ta�ve informa�on about the project's impact).

Research & Development (R&D): All research ac�vi�es, both basic and applied, and all development ac�vi�es that are performed by HHS award Recipients. The term research also includes ac�vi�es involving the training of individuals in research techniques where such ac�vi�es u�lize the same facili�es as other research and development ac�vi�es and where such ac�vi�es are not included in the instruc�on func�on. "Research' is defined as a systema�c study directed toward fuller scien�fic knowledge or understanding of the subject studied.

"Development' is the systema�c use of knowledge and understanding gained from research directed toward the produc�on of useful materials, devices, systems, or methods, including design and development of prototypes and processes.

Risk Analysis : A risk analysis is the process of assessing the likelihood of an adverse event occurring. It is the study of the underlying uncertainty of a given course of ac�on and refers to the uncertainty of forecasted cash flow streams, variance of por�olio returns, the probability of a project's success or failure, and possible future states.

Risk Management Plan: A Plan that describes a project's general approach for iden�fying, measuring, mi�ga�ng, and tracking risks as they arise through project development and its lifecycle. It should include an analysis of the risk’s probability, impact, as well as mi�ga�on strategies to help the project avoid being derailed should problems arise.

SAM (System for Awards Management): The SAM website provides a single comprehensive list of individuals and firms excluded by Federal government agencies from receiving Federal contracts or federally approved subcontracts and from certain types of Federal financial and nonfinancial assistance and benefits.

SOM (Statement of Objec�ves and Milestones): This is the nego�ated goals and objec�ves of the work to be performed and the key deliverables with �melines. Whenever possible, they should be performance based and �ed to a budget.

SOW (Statement of Work/Scope of Work): It is the narra�ve descrip�on of a project's work requirement. It defines project-specific ac�vi�es, milestones, deliverables, and �melines that lays the founda�on for the planning and successful execu�on of a project. This includes aims, objec�ves, and purposes of an award; as well as the methodology, approach, analyses, or other ac�vi�es; and the tools, technologies, and �meframes needed to meet the award's objec�ves.

SOO (Statement of Objec�ves): Provides the basic, high-level objec�ves. In this approach, the Recipients' proposals contain their statements of work and performance metrics and measures (which are based on their proposed solu�ons).

Staffing Plan: show the number and types or classifica�ons of employees a business needs to have on board over �me for an award based on the statement of work. A plan is to be developed for a specific, �me-limited project.

Subject inven�on: Any inven�on conceived or first actually reduced to prac�ce in the performance of work under this Agreement.

Sub Recipient: A subcontractor is an individual or a business that signs a contract to perform part or all the

OT# OD######-01

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SME (Subject Ma�er Expert): A person with bona fide, expert knowledge and exper�se in a specific subject for a project.

Technology: Discoveries, Innova�ons, Know-How and Inven�ons, whether patentable or not, including computer so�ware, recognized under U.S. law as intellectual crea�ons to which rights of ownership accrue, including, but not limited to, patents, trade secrets, mask works, and copyrights developed under this Agreement.

Term of Execu�on: The �me during which the Recipient ay incur new obliga�ons to carry out the work authorized under the Other Transac�ons.

Terms and Condi�ons: All legal requirements imposed on Other Transac�ons by NIH, whether based on statue, regula�on, policy, or other document referenced in the Agreement. The terms and condi�ons in Other Transac�ons Agreement(s) must protect the Federal Government's interests.

Total Costs: The total allowable costs (may include direct costs and F&A costs (indirect costs) incurred by the Recipient to carry out an OT-supported project or ac�vity. Total project costs include costs charged to the NIH OT and costs borne by the Recipient to sa�sfy a matching or cost-sharing requirement.

Underrepresented Group (URG): Group underrepresented in the biomedical, clinical, behavioral, and social sciences, such as people with disabili�es, people from disadvantaged backgrounds, and underrepresented racial and ethnic groups such as blacks or African Americans, Hispanics or La�nos, American Indians or Alaskan Na�ves, and Na�ve Hawaiians and other Pacific Islanders.

Unlimited Rights: The rights to use, disclose, reproduce, prepare deriva�ve 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 .

Work Breakdown Structure: A tool that breaks work into smaller tasks to make the work more manageable and approachable. It integrates scope, cost, and schedule baselines. It clearly demonstrates the rela�onship between the award deliverables and the scope.

C. Scope

Recipient shall perform <INSERT EFFORT>. The research shall be carried out in accordance with the Statement of Work incorporated in this Agreement as A�achment 2. They shall submit or otherwise provide all documenta�on required by A�achment 1, Report Requirements.

a. Recipient shall be paid in accordance with the Schedule of Payments and Payable Milestones set forth in A�achment 2 and the procedures of Ar�cle V. Both the Schedule of Payments and the Funding Schedule set forth in A�achment 3 may be revised or updated in accordance with Ar�cle III.

b. The Recipient shall perform a coordinated research and development program (herea�er referred to as “Program”) that shall be carried out in accordance with the “Statement of Work and Milestones and Deliverables” (SOM) hereby incorporated into this Agreement.

https://grants.nih.gov/grants/glossary.htm#UnderrepresentedGroup

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c. Subject to the availability of funds, the Recipient shall be paid based on funds made available in accordance with the Statement of Budgetary Projec�ons (SBP) hereby incorporated in this Agreement.

d. The Government and Recipient (Par�es) es�mate that the Statement of Work of this Agreement can only be accomplished with a Recipient aggregate resource contribu�on of $ <INSERT DOLLAR AMOUNT OR N/A> from the effec�ve date of this Agreement through <INSERT NUMBER OF MONTHS> months therea�er. Recipient intends and, by entering into this Agreement, undertakes to cause these funds to be provided. Recipient contribu�ons, if applicable, will be provided as detailed in the Funding Schedule set forth in A�achment 3.

e. If either NIH or Recipient is unable to provide its respec�ve total contribu�on, the other Party may reduce its project funding by a propor�onal amount. The Government will have con�nuous involvement with Recipient.

The Government will also obtain access to research results and certain rights in data and patents pursuant to Ar�cles VII and VIII. NIH and Recipient are bound to each other by a duty of good faith and best research effort in achieving the goals of the Program.

f. This Agreement is an “Other Transac�on” pursuant to Sec�on 402(n) of the Public Health Service Act, 42 U.S.C.

282(n). The Par�es agree that the principal purpose of this Agreement is for the Government to support and s�mulate Recipient to provide its best efforts in advanced research and technology development. It is not intended to be, nor shall it be construed as a partnership (in the strict legal sense), corpora�on, or other business organiza�on. This Agreement is not governed by the Federal Acquisi�on Regula�on (FAR), 2 CFR 200 or the NIH Grants Policy Statement but certain terms and condi�ons may use these to clarify commercial prac�ces and other industry best prac�ces where applicable. Other Transac�ons awards issued by the Na�onal Ins�tutes of Health (NIH) are deemed to meet the defini�on of “Research and Development” at 45 CFR Part§ 75.2.

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ARTICLE II: TERM

A. Term of this Agreement

The total period of performance of this Agreement commences upon the date of the last signature hereon and con�nues for <INSERT TOTAL NUMBER OF MONTHS> months. The current budget period funded under this Agreement is reflected on page 1. Provisions of this Agreement, which, by their express terms or by necessary implica�on, apply for periods of �me other than specified herein, shall be given effect, notwithstanding this Ar�cle.

B. Termina�on Provisions

Subject to a reasonable determina�on that the program will not produce beneficial results commensurate with the expenditure of resources, either Party may terminate this Agreement by wri�en no�ce to the other Party, provided that such wri�en no�ce is preceded by consulta�on between the Par�es. In the event of a termina�on of the Agreement, it is agreed that disposi�on of Data developed under this Agreement, shall be in accordance with the provisions set forth in Ar�cle VIII, Data Rights. The Government and Recipient will nego�ate in good faith a reasonable and �mely adjustment of all outstanding issues between the Par�es because of termina�on.

Failure of the Par�es to agree to a reasonable adjustment will be resolved pursuant to Ar�cle VI, Disputes. The Government has no obliga�on to pay Recipient beyond the last completed and paid milestone if Recipient decides to terminate. NIH and the Recipient should nego�ate in good faith a reasonable and �mely adjustment of all outstanding issues between the Par�es because of termina�on, which may include non-cancelable commitments.

NIH Termina�on:

If the NIH decides to terminate this award, the termina�on of the award will be considered a unilateral termina�on and the Recipient will not have the right to appeal. Although a decision is made to terminate, the Recipient must con�nue to comply with the Financial Records and Repor�ng Sec�on of this Agreement.

Recipient Termina�on:

The Recipient may terminate this Agreement by giving the NIH OTAO ninety (90) days wri�en no�fica�on of their intent to do so, provided that such wri�en no�ce is preceded by consulta�on between the Par�es. NIH and the Recipient should nego�ate in good faith a reasonable and �mely adjustment of all outstanding issues between the Par�es because of termina�on, which may include non-cancelable commitments.

C. Extending the Term

The Par�es may extend by mutual wri�en agreement the term of this Agreement as the Goals/Objec�ves reasonably warrant. Any extension shall be formalized through revision of the Agreement by the OTAO and the RBO and shall be subject to the availability of funds.

D. Flow Down of Terms

Lower Tier Agreements with Sub-Recipients/Subcontractors/Consultants must include the following Agreement terms, suitably modified to iden�fy the Par�es:

1. Obliga�on and Payment

2. Disputes

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3. Patent Rights

4. Data Rights

5. Applicable Statutes and Regula�ons

6. Informa�on Sharing

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ARTICLE III: MANAGEMENT OF THE PROJECT

The Recipient and Government shall together establish a Joint Oversight Commi�ee (“JOC”), which will be comprised of five (5) senior level members from Recipient (3 of which will be non-vo�ng), 2 senior level Government par�cipants, and the Other Transac�ons Agreements Officer (OTAO), Other Transac�ons Agreements Specialist (OTAS), and Other Transac�ons Technical Representa�ve (OTTR) who will a�end as non-vo�ng par�cipants. The Par�es may change the number of JOC par�cipants upon mutual agreement.

Addi�onal representa�ves from either Party or external advisors may also be included in this body on an ad hoc basis, as dictated by the circumstances. Either Party may subs�tute alternate senior level representa�ves, on either a temporary or an ongoing basis, by providing advance wri�en no�ce.

A. Risk Mi�ga�on and Purpose of JOC (Joint Oversight Commi�ee):

The responsibility of the Recipient/Government Joint Oversight Commi�ee is to mutually evaluate risks and the progress and performance of the requirements covered under this Agreement, to recommend and endorse any poten�al correc�ve ac�ons, and agree on modifica�ons to the alloca�on of funding of ac�vi�es covered under this Agreement.

The Recipient/Government Joint Oversight Commi�ee will meet annually, or as otherwise mutually agreed by the Par�es, by phone, ad-hoc, via video conference, or in-person to review progress. The JOC will recommend the strategy to be covered under this Agreement during the subsequent funding period, as well as how Government and Recipient funding will be allocated across these ac�vi�es. The recommenda�ons would be submi�ed, as appropriate, to the relevant Recipient governance board(s) for endorsement and decision. If endorsed by the Recipient and by the Government, the recommenda�ons will be incorporated into the SOW/SOM and this Agreement through modifica�ons. The Recipient will be solely responsible for the conduct of, and will have final decision-making authority for ac�vi�es within the SOW/SOM.

B. Project Mee�ngs

1. Project Teleconferences:

A conference call between the OTAO, OTPO, OTTR and/or OTAS and the Recipient’s Principal Inves�gator shall occur bi-weekly (every other week), or as mutually agreed by the Par�es. During this call, the Principal Inves�gator will discuss the ac�vi�es undertaken during the repor�ng period, any problems that have arisen and the ac�vi�es planned for the ensuing repor�ng period. The Principal Inves�gator may choose to include other key personnel on the conference call to give detailed updates on specific projects as may be requested by the OTAO, OTPO, OTTR and/or OTAS. A wri�en account of the mee�ng minutes will be provided as a deliverable to the OTTR/OTAS.

2. Other Mee�ngs:

In addi�on to Project Teleconferences, Recipient and the Government shall par�cipate in addi�onal Project Mee�ngs to coordinate the performance of the Agreement. These mee�ngs may include face-to-face mee�ngs with NIH All of Us Research Program staff in Rockville, MD and at work sites of the Recipient, Affiliates, or any Sub-Recipients. Such mee�ngs may include, but are not limited to, mee�ngs of the Recipient (and Sub-Recipients invited by the Recipient) to discuss study designs, site visits to the Recipient’s and Sub-Recipient’s facili�es, and mee�ngs with the Recipient and Government officials to discuss the technical, financial, regulatory, and ethical aspects of the Program. To facilitate review of Agreement ac�vi�es, it is expected that the Recipient will provide

: T emplat e data, reports, and presenta�ons to Government personnel as requested by the OTTR and/or OTAS. Recipient shall provide i�nerary/agenda at least five (5) business days in advance of any face-to-face mee�ng. The Recipient shall no�fy the OTTR and OTAS of formal and informal correspondence with the Food and Drug Administra�on (FDA) or other regulatory agencies regarding ac�ons associated with this agreement. Recipient shall not be required to no�fy the OTTR and OTAS of any correspondence that does not materially impact a Program.

3. In Process Review Mee�ng (IPR):

As the Government deems necessary, but no more frequently than annually, the Government may invite the Recipient to give a presenta�on at an In Process Review Mee�ng a�ended by All of Us Research Program, and select, invited interagency representa�ves and other interested Government par�es, as needed. The Recipient will present Data generated under this Agreement. Progress against Por�olio Performance Metrics will be assessed. Successes and challenges of the Program will be discussed and plans for the coming year will be presented.

C. Document Review

The Recipient shall provide the Government sufficient opportunity to review study protocols, reports, and regulatory correspondence.

The Government’s review and comments on these documents are non-binding and advisory in nature.

D. Management Systems, Procedures and Program Structure

Technical and program management of the coordinated research program established under this Agreement shall be accomplished through the management structures and processes detailed in this ar�cle. The Recipient shall be responsible for the overall management of the award including technical, programma�c, repor�ng, financial and administra�ve ma�ers. The Recipient is expected to have in use clearly delineated roles and responsibili�es for its organiza�on’s staff, both programma�c and administra�ve; wri�en policies and procedures; training; management controls and other internal controls; performance assessment; administra�ve simplifica�ons; and informa�on sharing. The Recipient may use its exis�ng systems to manage agreement funds and ac�vi�es if policies and procedures are consistently applied across its business func�ons.

The OTAO and/or the OTTR/OTAS shall fully par�cipate in all mee�ngs. Other government personnel as deemed appropriate may also par�cipate in the technical por�on of these mee�ngs. The OTPO shall provide recommenda�ons to Recipient on developments and technical collabora�on and be responsible for the review and verifica�on of the milestone objec�ves and deliverables.

In signing this Agreement, the RBO cer�fies that the Recipient will comply with all applicable assurances, and cer�fica�ons referenced in the Agreement and accompanying award. The RBO’s signature further cer�fies that the Recipient will be accountable both for the appropriate use of funds awarded and for the performance of the SOM (Statement of Objec�ves and Milestones). The RBO is the responsible individual for ensuring that the Recipient complies with applicable Federal laws and regula�ons, including required cer�fica�ons and assurances, its applica�on and terms and condi�ons of the Agreement and accompanying award.

E. Property Management System Standards

Generally, Recipients may use their own property management policies and procedures for property purchased, constructed, or fabricated as a direct cost using NIH OT award funds. Recipients are required to be prudent in the

: T emplat e acquisi�on of property under an OT award- supported project. It is the Recipient’s responsibility to conduct a prior review of each proposed property acquisi�on to ensure that the property is needed and that the need cannot be met with property already in the possession of the organiza�on.

F. Procurement System Standards and Requirements

Recipients may acquire a variety of goods or services in connec�on with an OT award-supported project, ranging from those that are rou�nely purchased goods or services to those that involve substan�ve programma�c work.

Recipients must acquire goods and services under OT awards in compliance with the organiza�on's established policies and procedures.

G. Program Plan

The program management and planning process shall be subject to quarterly and annual reviews with inputs and concurrence by the OTTR and OTPO.

1. Ini�al Program Plan:

The Recipient will follow the ini�al program plan that is contained in the Statement of Work (A�achment 2), and the Funding Schedule and Statement of Budgetary Projec�ons (A�achment 3).

H. Overall Program Plan Annual Review

The Recipient, with the OTTR/OTAS par�cipa�on and review, will prepare an overall Annual Program Plan in the first quarter of each Agreement year. (For this purpose, each consecu�ve twelve (12) month period from (and including) the month of execu�on of this Agreement during which this Agreement shall remain in effect shall be considered an “Agreement Year.”) The Annual Program Plan will be presented and reviewed at an annual site review concurrent with the appropriate quarterly mee�ng of the Recipient which will be a�ended by the Recipient Members, the Award Specialist, Senior All of Us Research Program Management or the Other Transac�ons Program Managers and personnel as appropriate. The Recipient, with NIH par�cipa�on and review, will prepare a final Annual Program Plan. The Annual Program Plan provides a detailed schedule of research ac�vi�es, commits the Recipient to meet specific performance objec�ves, and describes the Payable Milestones.

The Annual Program Plan will consolidate all prior adjustments in the research schedule, including revisions/modifica�ons to prospec�ve payable milestones. Recommenda�ons for changes and technical revisions or modifica�ons to the Agreement which result from the Annual Review shall be made in accordance with the provisions of Ar�cle III, Sec�on I – Modifica�ons.

I. Modifica�ons

As a result of mee�ng(s), annual reviews, or at any �me during the term of the Agreement, research progress or results may indicate that a change in the SOM would be beneficial to program objec�ves. Recommenda�ons for modifica�ons, including jus�fica�ons to support any changes to the Statement of Objec�ves and Milestone, will be documented in a le�er and submi�ed by Recipient to the OTTR and OTAS with a copy to the OTAO. This documenta�on le�er will detail the technical, chronological, and financial impact of the proposed modifica�on to the research program. The Government is not obligated to pay for addi�onal or revised Payable Milestones un�l the Milestones Schedule (A�achment 2) is formally revised by the OTAO and made part of this Agreement.

NIH is not obligated to pay for addi�onal or revised future objec�ves and milestones un�l the SOM is formally revised by the OTAO and made part of this Agreement via Modifica�on.

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At any �me during the term of the award, progress or results may indicate that a change in the Goals/Objec�ves and/or milestones would be beneficial to Program objec�ves, recommenda�ons to modify the Goals/Objec�ves and/or milestones may be ini�ated by either party. The ini�a�ng party will document in wri�ng and submit to the other party its recommenda�ons for modifying the Goals/Objec�ves and/or milestones, including jus�fica�ons to support the change. The OTAO and the RBO shall approve any Agreement modifica�on on a bilateral basis. The Other Transac�ons Scien�fic Program Director shall be responsible for the review and verifica�on of any recommenda�ons to revise or otherwise modify the Goals/Objec�ves and/or milestones, prospec�ve milestones, or other proposed changes to the terms and condi�ons of this Agreement. The OTTR/OTAS shall be responsible for the review and verifica�on of any recommenda�ons to revise or otherwise modify the Agreement Statement of Work, Schedule of Payments or Payable Milestones, or other proposed changes to the terms and condi�ons of this Agreement. The OTAO shall be responsible for all official approvals related to the award. This includes but is not exclusive of documen�ng, communica�ng, and securing any necessary approvals related to modifica�ons to this Agreement.