ROA OTA-22-006_APPENDIX A_Terms and Conditions_Revised Template.pdf

OT2OD######-####

OTHER TRANSACTIONS AGREEMENT

BETWEEN

NAME OF ORGANIZATION

Full Address of Organization

AND

NATIONAL INSTITUTES OF HEALTH

ALL OF US RESEARCH PROGRAM

6710B Rockledge Drive, Bethesda, Maryland 20817

DATE: XX/XX/XXXX

CONCERNING

<INSERT RESEARCH AND DEVELOPMENT TITLE>

Agreement No.: OT2OD###### 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

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

This Other Transactions Agreement (hereinafter, Agreement) is entered into between the United States of America, hereinafter called the Government, represented by the National Institute of Health (NIH) and the <INSERT NAME OF ORGANIZATION> pursuant to and under U.S. Federal law.

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 Transactions Agreements Officer (OTAO)

**insert OTAO name** **insert OTAO title**

Contents

ORDER OF PRECEDENCE 7

EXECUTION 7

ARTICLE I: SCOPE OF THE AGREEMENT 8

A. Background of the All of Us Research Program 8

B. Definitions 8

C. Scope 15

ARTICLE II: TERM 17

A. Term of this Agreement 17

B. Termination Provisions 17

C. Extending the Term 17

D. Flow Down of Terms 17

ARTICLE III: MANAGEMENT OF THE PROJECT 19

A. Risk Mitigation and Purpose of JOC (Joint Oversight Committee): 19

B. Project Meetings 19

1. Project Teleconferences: 19

2. Other Meetings: 19

3. In Process Review Meeting (IPR): 20

C. Document Review 20

D. Management Systems, Procedures and Program Structure 20

E. Property Management System Standards 21

F. Procurement System Standards and Requirements 21

G. Program Plan 21

H. Overall Program Plan Annual Review 21

I. Modifications 21

J. Monitoring 22

K. Programmatic, Meeting, and Financial Reporting Requirements 22

ARTICLE IV: AGREEMENT ADMINISTRATION/ROLES AND RESPONSIBILITIES 23

A. Government Points of Contact: 23

B. Recipient Points of Contact 23

C. Key Partners/Stakeholders 24

D. Key Personnel/PI(s) 24

E. Other Project-Support Personnel Restrictions

F. Reporting of Other Support 25

G. Roles and Responsibilities 25

Recipient Business Official (RBO) 26

Principal Investigator (PI) 26

Other Transactions Agreements Officer (OTAO) 26

Other Transactions Agreements Specialist (OTAS) 26

Other Transactions Technical Representative (OTTR) 27

Other Transactions Program Official (OTPO) 27

Other Transactions Scientific Program Director 27

ARTICLE V: OBLIGATION, PAYMENT AND COST CONSIDERATIONS 28

A. Obligation 28

B. Funding 28

C. Payments 28

D. Interest Earned on Advances 28

E. Lower Tier Agreement Costs 28

F. Limitation of Funds 29

G. Salary Cap: 29

H. Undisbursed Obligated Balances and Actual Expenditures 29

I. Cost Principles 29

J. Direct Costs and Indirect Costs/Facilities and Administrative Costs(F&A) 29

K. Appropriation Mandates 30

L. Travel Approval 30

M. Financial Management System Standards; Financial Records and Reporting 30

Financial Management System Standards 30

Financial Records and Reports 30

N. Notification of Claim Against Recipient: 31

O. Lower Tier Agreement Costs: 31

P. Unallowable Costs: 31

Pre-award costs 31

Q. Prior Approval Requirements: 32

R. Audit Requirements: 32

Additional program-specific audit elections 33

S. Close out Procedures 33

Close out of Fixed Year Appropriations Accounts 33

Record Retention and Access 34

T. FedRAMP, Cloud Security, Operations, and Compliance Direct Costs 34

ARTICLE VI: DISPUTES 35

A. General 35

B. Dispute Resolution Procedures 35

C. Limitation of Damages 35

D. 3rd Party Oversight and Evaluation 35

ARTICLE VII: PATENT RIGHTS. 36

A. Allocation of Principal Rights 36

B. Invention Disclosure, Election of Title, and Filing of Patent Application 36

C. Conditions When the NIH May Obtain Title 37

D. Minimum Rights to the Recipient and Protection of the Recipient’s Right to File 37

E. Action to Protect the NIH’s Interest 38

F. Reporting on Utilization of Subject Inventions 38

G. March-in Rights 38

ARTICLE VIII: DATA RIGHTS 40

Data Sharing Policy 40

A. Allocation of Principal Rights 40

B. Marking of Data 40

C. Termination Data Rights 40

D. Background Data 41

E. Basis of Assertion 41

F. Asserted Rights Category 41

G. Identification and Disposition of Data 42

Marking of Data 42

Lower Tier Awards 42

H. Genomic Data Sharing (GDS) Policy 42

I. Protection of Information 42

ARTICLE IX: FOREIGN AFFILIATION 44

ARTICLE X: CIVIL RIGHTS ACT 45

ARTICLE XI: SPECIAL CLAUSES 46

A. Material Transfer Agreement 46

B. Attribution Statement 46

C. NIH Product Owners 46

D. All of Us Research Program Website 46

E. Preference for American Industry 46

F. External Communications 47

G. Public Release or Dissemination of Information 47

NIH Public Access Policy 47

Sharing Research Resources 47

Human Subject Data Sharing 48

Review of Press Releases 48

H. Risk Assessment 48

I. Certificates of Confidentiality 48

J. Lobbying Prohibition 48

K. Promotion or Legalization of Controlled Substances 49

L. Dissemination of False or Deliberately Misleading Information 49

M. Restriction of Pornography on Computer Networks 49

N. USA Patriot Act 50

O. Rehabilitation Act of 1973 50

P. Research Involving Recombinant or Synthetic Nucleic Acid Molecules 50

Q. Select Agents 50

R. Federal Information Security Management Act (FISMA) 51

S. All of Us Research Program Data Security Framework 51

T. Prohibition on Funding for Certain Telecommunications Video Surveillance

Services or Equipment 55

U. Organizational and Personal Conflict of Interests 57

V. National Environmental Policy Act 58

W. Pro-Children Act of 1994 58

X. Debarment and Suspension 58

ATTACHMENT 1: REPORT REQUIREMENTS 55

A. MONTHLY REPORT 55

1. Technical Status Section 55

2. Financial Section. 57

B. ANNUAL PROGRAM PLAN DOCUMENT 58

C. AD HOC/SPECIAL TECHNICAL REPORTS 58

D. FINAL REPORT 58

Executive Summary 58

ATTACHMENT 2: TASK DESCRIPTION DOCUMENT (SOW/SOO) AND MILESTONES 60

ATTACHMENT 3: FUNDING SCHEDULE AND STATEMENT OF BUDGETARY PROJECTIONS 61

A. PROJECTED PROGRAM FUNDING 61

B. STATEMENT OF BUDGETARY PROJECTIONS 61

ORDER OF PRECEDENCE

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

EXECUTION

This Agreement constitutes the entire agreement of the Parties and supersedes all prior and contemporaneous agreements, understandings, negotiations, and discussions among the Parties, whether oral or written, with respect to the subject matter hereof. This Agreement may be revised only by written consent of the Recipient and the NIH Other Transactions Agreements Officer (OTAO). This Agreement, or modifications thereto, may be executed in counterparts each of which shall be deemed as original, but all of which taken together shall constitute one and the same instrument.

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 conditions. This creates more opportunities 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

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 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 participants, and it is developing new approaches to generate, access, and make data broadly available to approved researchers. Elements of the program protocol include health questionnaires, electronic health records (EHRs), physical measurements, the use of digital health technology, and the collection and analysis of biospecimens.

B. Definitions

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

Agreement: The body of this Other Transactions Agreement and its Attachments, which are expressly incorporated in and made a part of the Agreement.

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

Annual Program Plan: A detailed schedule of research activities that documents the Recipients ability to meet specific performance objectives and describes the payable milestones (as applicable)

ATO (Authorization to Operate): The official management decision given by a senior organizational official to authorize operation of an information system and to explicitly accept the risk to organizational operations (including mission, functions, image, or reputation), organizational assets, individuals, other organizations, and the Nation based on the implementation of an agreed-upon set of security controls.

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 this Agreement. All official correspondence must be submitted by the RBO.

Broad Agency Announcement (BAA): A method used by the NIH to solicit proposals for research and development projects by “soliciting for solutions”. 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, cooperative agreement, or other transactions.

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

Communications Plan: Provides a roadmap for getting the message delivered to All of Us Research Program stakeholders that is clear, specific and has measurable results. It includes defining the communication objectives, key audiences, and channels of communication. It also provides a timeline for completion of the steps for developing translations of materials into other languages and sharing the communications as well as who is responsible for and needs to be looped in on the development of the communications. This is used interchangeably with Communications Strategy Plan.

Data: Recorded information, regardless of form or method of recording, which includes but is not limited to, technical data, software, mask works and trade secrets. The term does not include financial, administrative, cost, pricing or management information and does not include subject inventions. The term does not include financial, administrative, cost, pricing or management information and does not include subject inventions, included in Article VII.

Delegation of Authority: The specific, formal deputation, assignment, or commitment of a legal power or right to take certain actions and to make certain decisions having legal significance. Such delegations must be stated in writing by the official authorized, called the OTAO, to delegate the authority.

Direct Cost: The costs that can be identified specifically with a particular sponsored project, an instructional activity, or any other institutional activity, or that can be directly assigned to such activities relatively easily with a high degree of accuracy.

Engagement Plan: Defines and documents the approach and actions that will be taken to increase input and support and minimize the negative impacts of external stakeholders throughout the life of the project. The plan must list the stakeholders with which the project will engage, prioritize which stakeholders will have the most influence on the project, identify at which stage each stakeholder will be involved in, and the timelines 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 addition to actual, allowable costs, paid to an organization providing goods or services consistent with normal commercial practice. This payment also is referred to as profit.

First in-First-Out Undisbursed Obligated Funds: Undisbursed obligated balances that expire may stay within an account for up to five additional years and can be used only to cover upward adjustments of prior-year obligations. Oldest funds will be used first before moving to newer funds.

FISMA: The Federal Information Security Management Act is legislation that defines a framework of guidelines and security standards to protect government information and operations. This risk management framework was signed into law as part of the Electronic Government.

https://policymanual.nih.gov/6035

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

The agency is separated into divisions that oversee food, drugs, cosmetics, animal food, dietary supplements, medical devices, biological goods, and blood products. The All of Us Research Program primarily collaborates with them over their association with Genetic Materials, such as blood and saliva.

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

Government: The United States of America, as represented by 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 information

Indirect Cost: Any cost that can’t be directly identified with a single, final cost objective, but is identified with two or more final cost objectives or an intermediate cost objective. For reasons of practicality, any direct cost of minor dollar amount may be treated as an indirect cost if the accounting treatment is consistently applied to all cost objectives and the treatment produces substantially the same results as treating the cost as a direct cost.

Intellectual Property (IP): The creative 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 inventions, patents, trademarks, unfair competition, copyrights, trade secrets, data and Technical Data, the right of publicity, and new plant varieties. Examples of intellectual property include inventions;

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

Invention: Any invention 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 practice in the performance of work under this Agreement.

Institutional Review Board (IRB) Plan: Provides the process for identifying all aspects of a project that require review by the All of Us Research Program Institutional Review Board (IRB). It also provides a timeline 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, communications, data collection instruments (surveys, interview questions), and consent forms.

Independent Research and Development (IR&D) Expenses: An expense used in accounting for independent research and development costs that shall be allocated to final cost objectives on the same basis of allocation used for the General and Administrative (G&A) expense grouping of the profit center.

ISSO: The Information System Security Officer (ISSO) serves as the principal advisor to the Information System Owner (SO), Business Process Owner, and the Information System Security Manager (ISSM) as applicable on all matters, technical and otherwise, involving the security of an information system. ISSOs are responsible for ensuring the implementation and maintenance of security controls in accordance with the Security Plan (SP) and the Recipient policies. In almost all cases, ISSOs will be called on to provide guidance, oversight, and expertise, but they may or may not develop security documents or implement any security controls.

IT Security Plan: Provides a comprehensive assessment and/or evaluation of information system policies, technical / non-technical security components, documentation, supplemental safeguards, policies, and vulnerabilities to determine project compliance with All of Us Research Program security standards. This may include the requirement for a formal declaration of an information system accreditation or Authority to Operate

(ATO).

Joint Oversight Committee (JOC): Comprised of 5 senior level members from Recipient (3 of which will be non-voting), 2 senior level Government participants, and the Other Transactions Agreements Officer (OTAO), Other Transactions Agreements Specialist (OTAS), and Other Transactions Technical Representative (OTTR) who will attend as non-voting participants

Key Personnel: Individuals who contribute to the scientific development or execution of a project in a substantive measurable way. The program director/principal investigator (PI) are always considered key personnel.

Know-How: All information including, but not limited to discoveries, formulas, materials, inventions, processes, ideas, approaches, concepts, techniques, methods, software, programs, documentation, procedures, firmware, hardware, technical data, specifications, devices, apparatus, and machines.

Level of Effort (LOE): A support-type project activity that must be done to support other work activities or the entire 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 investigators of OT Awards the All of Us Research Program requires that the total percentage for multiple 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 commodities being procured (labor hours of services, funding for travel, quantity of product A, quantity of product B, etc.) and (2) they provide for traceable accounting classification citations. It is often driven by internal government accounting requirements like fiscal years and appropriations that are often not visible to the outside observer.

Made: Relates to any invention means the conception or first actual reduction to practice of such invention.

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

Notice 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 Transactions Agreements Officer, notifies the Recipient of their receipt of an Other Transaction award, contains references to all terms and conditions, and includes federal funding limits and obligations.

Nondisclosure Agreement: A legal contract in which the parties involved agree to keep the information included private. This type of contract creates a confidential relationship between the parties and protects the confidential or proprietary information outlined in the Agreement, as breaching a nondisclosure agreement generally subjects the party to severe civil penalties.

Non-Federal Entity: A state, local government, Indian tribe, institution of higher education, or nonprofit organization that carries out a federal award as a Recipient or subRecipient of the Other Transaction.

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

Operations Plan: This plan describes the ongoing monitoring of project or application usage and analytics, and the process for identifying and conducting needed updates, modifications, and required for All of Us applications including but not limited to security updates and code maintenance, conduct of yearly application audits, design and feature enhancements, performance monitoring. It should include how users will request modifications and report problems. The plan should also define and quantify the workload and budget required for ongoing maintenance and updates

Other Transactions (OT) Agreements: The awards made pursuant to Other Transactions Authorities are commonly referred to as Other Transactions or “Other Transactions Agreements.” An Other Transactions 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 transactions other than procurement contracts, grants, or cooperatives agreements. Only those agencies that have been provided Other Transactions Authority may engage in other transactions.

Other Transactions Agreements Officer (OTAO): A warranted or certified individual authorized to execute Other Transactions on behalf of the Government. An OTAO is responsible for legally committing the government to an Other Transaction; has the ability to enter into, administer, and terminate Other Transactions; and possess a level of responsibility, business acumen, and judgment that enables them to operate in a relatively unstructured environment.

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

Other Transactions Program Official (OTPO): The NIH Federal official responsible for the programmatic, scientific, and/or technical aspects of their assigned Other Transaction projects.

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

Other Transactions Scientific Director (OTSD): Identified in the OT Agreement, the OTSD must have the appropriate scientific or technical background to provide programmatic input and expertise, in close partnership with the Other Transactions Program Official and Other Transactions Agreements Officer. The OTSD typically serves under the direction of the program and is authorized to provide single voice technical direction to the Recipient on behalf of the government. In offering this direction, the OTSD will collaborate closely with colleagues to bring forward the knowledge and expertise needed to meet strategic goals within the framework of the initiative governance.

Other Transactions Technical Representative (OTTR): A designee of the Other Transactions Agreements Officer that provides day-to- day programmatic oversight, working closely with the Other Transactions Agreements Officer, the assigned Other Transactions 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 Transactions receive payments through this system.

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

Period of Performance (PoP): The time during which the Recipient may incur new obligations to carry out the work authorized under the award.

Plans of Action & Milestones (POA&Ms): A document that identifies tasks needing to be accomplished. It details resources required to accomplish the elements of the plan, any milestones in meeting the tasks, and scheduled completion dates for the milestones.

Practical Application: To manufacture, in the case of a composition of product; to practice, in the case of a process or method, or to operate, in the case of a machine or system; and, in each case, under such conditions as to establish that the invention is capable of being utilized and that its benefits are, to the extent permitted by law or Government regulations, available to the public on reasonable terms.

Program: Research and development organization, as set forth in Article I, paragraph C.

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

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

Recipient: The entity responsible for the administrative, financial, and programmatic activities described in the Agreement.

Reporting: An account given of a particular matter in the form of an official document or presentation. 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 information to ensure the Recipient is following the Other https://pms.psc.gov/

Transactions Agreement and federal regulations; and project data highlighting progress and/or community impact (e.g., quantitative information about the project's impact).

Research & Development (R&D): All research activities, both basic and applied, and all development activities that are performed by HHS award Recipients. The term research also includes activities involving the training of individuals in research techniques where such activities utilize the same facilities as other research and development activities and where such activities are not included in the instruction function. "Research' is defined as a systematic study directed toward fuller scientific knowledge or understanding of the subject studied. "Development' is the systematic use of knowledge and understanding gained from research directed toward the production 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 action and refers to the uncertainty of forecasted cash flow streams, variance of portfolio 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 identifying, measuring, mitigating, 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 mitigation 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 Objectives and Milestones): This is the negotiated goals and objectives of the work to be performed and the key deliverables with timelines. Whenever possible, they should be performance based and tied to a budget.

SOW (Statement of Work/Scope of Work): It is the narrative description of a project's work requirement. It defines project-specific activities, milestones, deliverables, and timelines that lays the foundation for the planning and successful execution of a project. This includes aims, objectives, and purposes of an award; as well as the methodology, approach, analyses, or other activities; and the tools, technologies, and timeframes needed to meet the award's objectives.

SOO (Statement of Objectives): Provides the basic, high-level objectives. In this approach, the Recipients' proposals contain their statements of work and performance metrics and measures (which are based on their proposed solutions).

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

Subject invention: Any invention conceived or first actually reduced to practice 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 https://hr.nih.gov/working-nih/competencies/competencies-dictionary/risk-analysishttps:/hr.nih.gov/working-nih/cohttps:/hr.nih.gov/working-nih/competencies/competencies-dictionary/risk-analysismpetencies/competencies-dictionary/risk-analysis https://www.sam.gov/ obligations of another's contract. A subcontractor is a company or person whom a general contractor, prime contractor or main contractor hires to perform a specific task as part of an overall project and normally pays for services provided to the project. This term is used interchangeably with Subcontractor.

SME (Subject Matter Expert): A person with bona fide, expert knowledge and expertise in a specific subject for a project.

Technology: Discoveries, Innovations, Know-How and Inventions, whether patentable or not, including computer software, recognized under U.S. law as intellectual creations to which rights of ownership accrue, including, but not limited to, patents, trade secrets, mask works, and copyrights developed under this Agreement.

Term of Execution: The time during which the Recipient may incur new obligations to carry out the work authorized under the Other Transactions.

Terms and Conditions: All legal requirements imposed on Other Transactions by NIH, whether based on statue, regulation, policy, or other document referenced in the Agreement. The terms and conditions in Other Transactions 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 activity. Total project costs include costs charged to the NIH OT and costs borne by the Recipient to satisfy a matching or cost-sharing requirement.

Underrepresented Group (URG): Group underrepresented in the biomedical, clinical, behavioral, and social sciences, such as people with disabilities, people from disadvantaged backgrounds, and underrepresented racial and ethnic groups such as blacks or African Americans, Hispanics or Latinos, American Indians or Alaskan Natives, and Native Hawaiians and other Pacific Islanders.

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 .

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 relationship 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 Attachment 2. They shall submit or otherwise provide all documentation required by Attachment 1, Report Requirements.

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

b. The Recipient shall perform a coordinated research and development program (hereafter referred to as “Program”) that shall be carried out in accordance with the “Statement of Work and Milestones and https://grants.nih.gov/grants/glossary.htm#UnderrepresentedGroup

Deliverables” (SOM) hereby incorporated into this Agreement.

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

d. The Government and Recipient (Parties) estimate that the Statement of Work of this Agreement can only be accomplished with a Recipient aggregate resource contribution of $ <INSERT DOLLAR AMOUNT OR N/A> from the effective date of this Agreement through <INSERT NUMBER OF MONTHS> months thereafter. Recipient intends and, by entering into this Agreement, undertakes to cause these funds to be provided. Recipient contributions, if applicable, will be provided as detailed in the Funding Schedule set forth in Attachment 3.

e. If either NIH or Recipient is unable to provide its respective total contribution, the other Party may reduce its project funding by a proportional amount. The Government will have continuous involvement with Recipient.

The Government will also obtain access to research results and certain rights in data and patents pursuant to Articles 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 Transaction” pursuant to Section 402(n) of the Public Health Service Act, 42 U.S.C.

282(n). The Parties agree that the principal purpose of this Agreement is for the Government to support and stimulate 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), corporation, or other business organization. This Agreement is not governed by the Federal Acquisition Regulation (FAR), 2 CFR 200 or the NIH Grants Policy Statement, but certain terms and conditions may use these to clarify commercial practices and other industry best practices where applicable. Other Transactions awards issued by the National Institutes of Health (NIH) are deemed to meet the definition of “Research and Development” at 45 CFR Part§ 75.2.

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 continues 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 implication, apply for periods of time other than specified herein, shall be given effect, notwithstanding this Article.

B. Termination Provisions

Subject to a reasonable determination that the program will not produce beneficial results commensurate with the expenditure of resources, either Party may terminate this Agreement by written notice to the other Party, provided that such written notice is preceded by consultation between the Parties. In the event of a termination of the Agreement, it is agreed that disposition of Data developed under this Agreement, shall be in accordance with the provisions set forth in Article VIII, Data Rights. The Government and Recipient will negotiate in good faith a reasonable and timely adjustment of all outstanding issues between the Parties because of termination.

Failure of the Parties to agree to a reasonable adjustment will be resolved pursuant to Article VI, Disputes. The Government has no obligation to pay Recipient beyond the last completed and paid milestone if Recipient decides to terminate. NIH and the Recipient should negotiate in good faith a reasonable and timely adjustment of all outstanding issues between the Parties because of termination, which may include non-cancelable commitments.

NIH Termination:

If the NIH decides to terminate this award, the termination of the award will be considered a unilateral termination and the Recipient will not have the right to appeal. Although a decision is made to terminate, the Recipient must continue to comply with the Financial Records and Reporting Section of this Agreement.

Recipient Termination:

The Recipient may terminate this Agreement by giving the NIH OTAO ninety (90) days written notification of their intent to do so, provided that such written notice is preceded by consultation between the Parties. NIH and the Recipient should negotiate in good faith a reasonable and timely adjustment of all outstanding issues between the Parties because of termination, which may include non-cancelable commitments.

C. Extending the Term

The Parties may extend by mutual written agreement the term of this Agreement as the Goals/Objectives 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 identify the Parties:

1. Obligation and Payment

2. Disputes

3. Patent Rights

4. Data Rights

5. Applicable Statutes and Regulations

6. Information Sharing

7. Special Clauses, as applicable

ARTICLE III: MANAGEMENT OF THE PROJECT

The Recipient and Government shall together establish a Joint Oversight Committee (“JOC”), which will be comprised of five (5) senior level members from Recipient (3 of which will be non-voting), 2 senior level Government participants, and the Other Transactions Agreements Officer (OTAO), Other Transactions Agreements Specialist (OTAS), and Other Transactions Technical Representative (OTTR) who will attend as non-voting participants. The Parties may change the number of JOC participants upon mutual agreement.

Additional representatives 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 substitute alternate senior level representatives, on either a temporary or an ongoing basis, by providing advance written notice.

A. Risk Mitigation and Purpose of JOC (Joint Oversight Committee):

The responsibility of the Recipient/Government Joint Oversight Committee is to mutually evaluate risks and the progress and performance of the requirements covered under this Agreement, to recommend and endorse any potential corrective actions, and agree on modifications to the allocation of funding of activities covered under this Agreement.

The Recipient/Government Joint Oversight Committee will meet annually, or as otherwise mutually agreed by the Parties, 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 activities. The recommendations would be submitted, as appropriate, to the relevant Recipient governance board(s) for endorsement and decision. If endorsed by the Recipient and by the Government, the recommendations will be incorporated into the SOW/SOM and this Agreement through modifications. The Recipient will be solely responsible for the conduct of, and will have final decision-making authority for activities within the SOW/SOM.

B. Project Meetings

1. Project Teleconferences:

A conference call between the OTAO, OTPO, OTTR and/or OTAS and the Recipient’s Principal Investigator shall occur bi-weekly (every other week), or as mutually agreed by the Parties. During this call, the Principal Investigator will discuss the activities undertaken during the reporting period, any problems that have arisen and the activities planned for the ensuing reporting period. The Principal Investigator 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 written account of the meeting minutes will be provided as a deliverable to the OTTR/OTAS.

2. Other Meetings:

In addition to Project Teleconferences, Recipient and the Government shall participate in additional Project Meetings to coordinate the performance of the Agreement. These meetings may include face-to-face meetings with NIH All of Us Research Program staff in Bethesda, MD and at work sites of the Recipient, Affiliates, or any Sub-Recipients. Such meetings may include, but are not limited to, meetings of the Recipient (and Sub- Recipients invited by the Recipient) to discuss study designs, site visits to the Recipient’s and Sub-Recipient’s facilities, and meetings with the Recipient and Government officials to discuss the technical, financial, regulatory, and ethical aspects of the Program. To facilitate review of Agreement activities, it is expected that the Recipient will provide data, reports, and presentations to Government personnel as requested by the OTTR and/or OTAS. Recipient shall provide itinerary/agenda at least five (5) business days in advance of any face-to-face meeting. The Recipient shall notify the OTTR and OTAS of formal and informal correspondence with the Food and Drug Administration (FDA) or other regulatory agencies regarding actions associated with this agreement. Recipient shall not be required to notify the OTTR and OTAS of any correspondence that does not materially impact a Program.

3. In Process Review Meeting (IPR):

As the Government deems necessary, but no more frequently than annually, the Government may invite the Recipient to give a presentation at an In Process Review Meeting attended by All of Us Research Program, and select, invited interagency representatives and other interested Government parties, as needed. The Recipient will present Data generated under this Agreement. Progress against Portfolio 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 article. The Recipient shall be responsible for the overall management of the award including technical, programmatic, reporting, financial and administrative matters. The Recipient is expected to 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 if policies and procedures are consistently applied across its business functions.

The OTAO and/or the OTTR/OTAS shall fully participate in all meetings. Other government personnel as deemed appropriate may also participate in the technical portion of these meetings. The OTPO shall provide recommendations to Recipient on developments and technical collaboration and be responsible for the review and verification of the milestone objectives and deliverables.

In signing this Agreement, the RBO certifies that the Recipient will comply with all applicable assurances, and certifications referenced in the Agreement and accompanying award. The RBO’s signature further certifies that the Recipient will be accountable both for the appropriate use of funds awarded and for the performance of the SOM (Statement of Objectives and Milestones). The RBO is the responsible individual for ensuring that the Recipient complies with applicable Federal laws and regulations, including required certifications and assurances, its application and terms and conditions 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 acquisition of property under an OT award-supported project. It is the Recipient’s responsibility to conduct a prior review of each proposed property acquisition to ensure that the property is needed and that the need cannot be met with property already in the possession of the organization.

Title and Disposition of Property

Title to any item of property with an acquisition value greater than $XXXX that was included in the budget/cost proposal that is acquired by the Recipient shall vest with the Government unless otherwise determined by the OTAO. Should any item of property with an acquisition value greater than $XXXX be required after the Government’s approval of the budget/cost proposal, the Recipient shall obtain prior written approval from the OTAO, if the budget/cost proposal did not specifically identify the proposed property. Upon written approval of the OTAO, title to this property may vest with the Recipient upon acquisition. The Recipient shall be responsible for the maintenance, repair, protection and preservation of all such property at its own expense. Property acquired shall not be considered as in exchange for services in performance of the award, but shall be considered a Government contribution to the Project.

The Recipient shall obtain explicit written authorization for any transfer or disposition of Government Furnished Property.

F. 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 the organization'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. Initial Program Plan:

The Recipient will follow the initial program plan that is contained in the Statement of Work (Attachment 2), and the Funding Schedule and Statement of Budgetary Projections (Attachment 3).

H. Overall Program Plan Annual Review

The Recipient, with the OTTR/OTAS participation and review, will prepare an overall Annual Program Plan in the first quarter of each Agreement year. (For this purpose, each consecutive twelve (12) month period from (and including) the month of execution 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 meeting of the Recipient which will be attended by the Recipient Members, the Award Specialist, Senior All of Us Research Program Management or the Other Transactions Program Managers and personnel as appropriate. The Recipient, with NIH participation and review, will prepare a final Annual Program Plan. The Annual Program Plan provides a detailed schedule of research activities, commits the Recipient to meet specific performance objectives, and describes the Payable Milestones.

The Annual Program Plan will consolidate all prior adjustments in the research schedule, including revisions/modifications to prospective payable milestones. Recommendations for changes and technical revisions or modifications to the Agreement which result from the Annual Review shall be made in accordance with the provisions of Article III, Section I – Modifications.

I. Modifications

As a result of meeting(s), annual reviews, or at any time during the term of the Agreement, research progress or results may indicate that a change in the SOM would be beneficial to program objectives. Recommendations for modifications, including justifications to support any changes to the Statement of Objectives and Milestone, will be documented in a letter and submitted by Recipient to the OTTR and OTAS with a copy to the OTAO.