POLICIES AND PROCEDURES

Transcription

1 Because breast cancer is everywhere, SO ARE WE. At Susan G. Komen for the Cure, we are committed to ENDING breast cancer forever by ENERGIZING SCIENCE to find the cures and ensuring QUALITY CARE for all people, everywhere. POLICIES AND PROCEDURES FOR RESEARCH AND TRAINING GRANTS Susan G. Komen for the Cure Research Programs 5005 LBJ Freeway, Suite 250 Dallas, Texas Toll free: Website: Issue Date: May 9, 2012

2 TABLE OF CONTENTS Introduction 3 1. Requirements of Individual Grant Mechanisms 3 2. Online Procedures 3 3. Grant Agreement Execution and Award Applicant Good Standing Submission of Required Documents Release of Final Grant Agreement Evaluation for Duplicative Funding Grant Agreement Effective Date Delay in Grant Start Date 4 4. Organizational Assurances Research Involving Human Subjects Research Involving Human Biological/Anatomical Material Research Involving Animals Required Documents Government Compliance 7 5. Required Grant Reports Online Report Submission Annual Scientific Progress Reports Final Research Report Financial Reports Other Reports and Engagements Non-Confidential Nature of Reports Timely Submission of Reports Funding and Payments Duration Consortia and/or Subcontracts Ownership of Research Equipment Payment Schedule Payment Form Indirect Costs Expenditures Out-of-Scope of Grant Personnel Costs Audits Changes in Grant Status Changes in Research Plan Change of Grantee Institution Change of Personnel Re-budgeting of Funds Carry Forward of Funds Acceleration of Funding No Cost Extensions Early Termination by Grantee for any Reason (Except Default) Early Termination by Initiated by Komen Publications and Komen Licensed Marks Intellectual Properties and Royalties 19 Sample Grant Agreement (Appendix A) 21 Policies and Procedures Page 2 of 26 Issue Date: May 9, 2012

3 INTRODUCTION A Research and/or Training Grant ( Grant ) is provided to support a research plan ( Research Plan ) as presented in a grant application (including approved modifications, if any) and approved for funding by Susan G. Komen for the Cure ( Komen for the Cure or Komen ). The specific terms and conditions applicable to a Grant awarded by Komen are set forth in these policies and procedures, as may be revised from time to time ( Policies and Procedures ) and the grant agreement ( Grant Agreement ), which incorporates by reference the Policies and Procedures. The Grant Agreement must be signed on behalf of the grantee institution ( Grantee Institution ) by an administrative official who has signatory authority (any such person referred to herein as the ASO ) and also must be signed by the principal investigator or fellow if the Grant is for a postdoctoral fellowship (both the principal investigator and fellow referred to herein as the PI ), any co-principal investigator ( Co-PI ), and the postdoctoral mentor ( Mentor ) if the grant is for a postdoctoral fellowship. In the case of multiple Grantee Institutions or multiple PIs or Co-PIs are involved in a research project, (i) all references to Grantee Institution will refer collectively to all the institutions involved; (ii) all references to PI or Co-PI will refer collectively to all principal investigators and co-principal investigators involved; and (iii) all references to Grantee will refer collectively to all PIs, Co-PIs, Mentors and Grantee Institutions involved. 1. REQUIREMENTS OF INDIVIDUAL GRANT MECHANISMS Each Komen grant mechanism has unique characteristics, such as duration, funding levels, recipient designations, eligibility requirements, project requirements, and permitted budget allocations. For applications submitted in response to a Request for Applications (RFA), these characteristics and requirements are detailed in the individual RFA for that grant mechanism and are incorporated by reference into these Policies and Procedures. 2. ONLINE PROCEDURES Komen Grants are managed through proposalcentral ( PC ), Komen s grants management software system for all active Research & Training Program Grants. Komen s former grants management software system, known as Komen Grants Management System (KGMS), serves as a data repository for all grants awarded prior to Komen s complete transition to PC in March Once a Grantee accepts Komen s notification of intent to fund, whether definite or contingent, the PI, any Co-PI, any Mentor and ASO who originally submitted application to Komen will be given authorization to use PC. Additional users may be authorized to access PC with prior approval of the ASO or PI and upon notification to Komen. For all technical inquiries related to PC (including questions related to system access, navigation, document uploads, etc.), Grantees should contact the PC Help Desk at pcsupport@altum.com, or (Toll-free within the United States and Canada) or (International). For programmatic assistance, Grantees should contact their Komen Science Manager or Komen Grants Administrator, as identified on the Contacts & User Access screen in PC. For general programmatic inquiries, Grantees should contact the Komen Grants Help Desk at helpdesk@komengrantsaccess.org or (Toll-free within the United States and Canada). Policies and Procedures Page 3 of 26 Issue Date: May 9, 2012

4 3. GRANT AGREEMENT EXECUTION AND AWARD 3.1 Applicant Good Standing Grantees past and current Komen-funded Grants must be up to date and in compliance with all Komen requirements prior to the execution of a Grant Agreement. 3.2 Submission of Required Documents Komen requires submission of certain financial information, applicant information, and regulatory documents (collectively referred to as Required Documents ) prior to execution of a Grant Agreement. Examples include: Institutional W-9 form for U.S. Grantee institutions or W-8BEN for foreign Grantee institutions Verification of automated Clearing House (ACH) electronic funds transfer information on file with Komen Institutional Review Board (IRB) and/or Institution Animal Care and Use Committee (IACUC) Regulatory documents indicating approval Institutional contact information for authorized signatory (pre and post-award) and financial officer (pre and post-award) Updated biographical narrative and picture for each PI, Co-PI and Mentor Sources of other financial support (current and pending) for each PI, Co-PI and Mentor IRS determination letter or other proof of Grantee Institution s Section 501(c)(3) tax exempt status or the international equivalent Completed critical, unique materials verification form Required Documents will be requested by Komen through PC and must be uploaded to PC within thirty (30) days of request by Komen, unless an extension of time has been granted by Komen. All Required Documents must be approved by Komen prior to the execution of the Grant Agreement. 3.3 Evaluation for Duplicative Funding Grantees may not receive funding from any other source that would result in an overlap in funding for the same research and/or training activities being conducted with funding from Komen. Applications for research funding require applicants to list all other research support including project title, specific aims, funding amount, duration, and source. Potential overlap in support is reviewed prior to awarding a Grant and is monitored annually throughout the term of each Grant. It is the PI s responsibility to report all sources of funding to Komen. 3.4 Release of Final Grant Agreement The final Grant Agreement must be signed by the PI, Co-PI (if any), the Mentor (if the Grant received is a postdoctoral fellowship), and the ASO and returned to Komen within thirty (30) days of the agreement being sent by Komen, unless an extension of time has been granted by Komen. 3.5 Grant Agreement Effective Date The effective date of the Grant Agreement is the date on which Komen signs the Grant Agreement, and shall serve as the start date of the Grant. No expenses may be accrued against the Grant until the Grant Agreement is executed by Komen, and Komen will not reimburse any costs incurred prior to the effective date of the Grant Agreement. 3.6 Delay in Grant Start Date Applicant may request a delay of the start date of the Grant of up to six (6) months after the date that Komen issues its notification of its intent to fund the applicant. Such requests must be sent within fourteen (14) days of the date of the notification of intent to fund through the Correspondence and Notes section in PC and must detail the reason for the delay and the expected Grant start date. Policies and Procedures Page 4 of 26 Issue Date: May 9, 2012

5 4. ORGANIZATIONAL ASSURANCES Komen does not assume responsibility for the conduct of a Research Plan or for the activities of PI, any Co-PI and Mentor and Grantee Institution, since they are under the scope and direction of the Grantee Institution and subject to its policies. However, Komen requires that applicants disclose at the time of application whether human subjects, human biological/anatomical materials, animals, recombinant DNA, biohazardous materials, or genetically engineered mechanisms will be used in the proposed research and to receive assurance that in the event the Grant is awarded, the PI, any Co-PI and Mentor, and the Grantee Institution will implement the necessary safeguards in the use of human subjects, human biological/anatomical materials, and animals in Komen-funded research. Regardless of whether the research is subject to U.S. Federal regulations, Komen requires the following: 4.1 Research Involving Human Subjects Research involving human subjects will be guided by one of the following statements of ethical principles: (a) The World Medical Association s Declaration of Helsinki (as amended in 2008); (b) The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research of the U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research; or (c) other appropriate international ethical standards recognized by U.S. Federal departments and agencies that have adopted the U.S. Federal Policy for the Protection of Human Subjects, known as the Common Rule. 4.2 Research Involving Human Biological/Anatomical Material Research involving the use of human biological and/or anatomical materials will be guided by the recommendations set forth in the National Institutes of Health, Office of Human Subjects Research Medical Administrative Series (MAS) #M01-2 entitled Procurement and Use of Human Biological Materials for Research. Summary information about the recommendations of the Tissue Resource Committee from which policies were developed and the policies and procedures contained in the MAS can be found at sheet17.html. Grantees from outside the United States must follow the guidelines established by an international equivalent governing the protection of human research subjects. In addition to the above, applicants must disclose in their applications if their projects involve recombinant DNA, biohazardous materials, genetically engineered mechanisms, human fetal tissues, and/or human anatomical substances. Wherever applicable, the research protocol will be reviewed and approved by the Grantee Institution s biohazards committee and conform to the relevant PHS guidelines. Susan G. Komen for the Cure Nancy G. Brinker promised her dying sister, Susan G. Komen, she would do everything in her power to end breast cancer forever. In 1982, that promise became Susan G. Komen for the Cure and launched the global breast cancer movement. Today, Komen for the Cure is the world s largest grassroots network of breast cancer survivors and activists fighting to save lives, empower people, ensure quality care for all and energize science to find the cures. Thanks to events like the Komen Race for the Cure, we have invested more than $1.9 billion to fulfill our promise, becoming the largest source of nonprofit funds dedicated to the fight against breast cancer in the world. Policies and Procedures Page 5 of 26 Issue Date: May 9, 2012

6 4.3 Research Involving Animals Research involving animals will be guided by the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals, or the International Guiding Principles for Biomedical Research Involving Animals, or the equivalent guidelines of an international animal welfare board. 4.4 Required Documents The following institutional approvals must be obtained by the Grantee and uploaded to PC prior to the involvement of human subjects, biological/anatomical material, or animals in Komen-funded research: IMPORTANT: Grantees are required to submit renewals of the documentation and approvals described below to Komen during the term of their Grants, and so long as the use of human subjects and/or laboratory animals are in effect.. HUMAN SUBJECTS & BIOLOGICAL/ ANATOMICAL MATERIAL USE ASSURANCES (IRB) Documentation of review and final approval by the Institutional Review Board ( IRB ) or international local ethics board equivalent including the type of review obtained, i.e., expedited or full board review ANIMAL USE ASSURANCES (IACUC) Documentation of the review and final approval of the Institutional Animal Care and Use Committee ( IACUC ) or international animal welfare board equivalent Verification of compliance with the Health Insurance Portability and Accountability Act of 1996 ( HIPAA ) Documentation of Office of Human Research Protection (OHRP) assurance or international equivalent Assurance that any research involving human subjects will be guided by one of the following statements of ethical principles: (i) The World Medical Association s Declaration of Helsinki (as amended in 2008); (ii) The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research of the U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research; or (iii) other appropriate international ethical standards recognized by U.S. federal departments and agencies that have adopted the U.S. Federal Policy for the Protection of Human Subjects, known as the Common Rule Samples of the human subject, patient, and/or biological/anatomical information informed consent documents Policies and Procedures Page 6 of 26 Issue Date: May 9, 2012

7 HUMAN SUBJECTS & BIOLOGICAL/ ANATOMICAL MATERIAL USE ASSURANCES (IRB) REQUIREMENTS Documentation must: Describe the same studies proposed in the Research Plan for the funded project. The award project title and IRB project titles, however, do NOT need to be an exact match Stipulate the project s approved beginning and/or renewal and expiration dates Be written on official Grantee Institution letterhead Be written in English and signed (physical or electronic) by an ASO. Note: If the original approval(s) is/are written in a language other than English, prior to submitting same to Komen, it/ they must be translated into English by a certified translator and include a statement attesting that the translator believes the English text to be an accurate and complete translation of the source language text ANIMAL USE ASSURANCES (IACUC) REQUIREMENTS Documentation must: Describe the same studies proposed in the Research Plan for the funded project. The award project title and IACUC project titles, however, do NOT need to be an exact match Stipulate the project s approved beginning and/or renewal and expiration dates Be written on official Grantee Institution letterhead Be written in English and signed (physical or electronic) by an ASO. Note: If the original approval(s) is/are written in a language other than English, prior to submitting same to Komen, it/they must be translated into English by a certified translator and include a statement attesting that the translator believes the English text to be an accurate and complete translation of the source language text 4.5 Government Compliance All Grantees must comply with all applicable laws in connection with their Grants. In addition, all Grantees must comply with PHS regulations, Final Rule, CFR Part 50, Subpart F, Responsibility of Applicants for Promoting Objectivity in Research, as may be amended from time to time, or the international, equivalent. Grantees must cooperate with Komen in supplying additional information to Komen and in complying with any procedures that might be required by any governmental agency in order for Komen to establish that it has observed all requirements of the law with respect to the Grants. 5. REQUIRED GRANT REPORTS Format and content requirements for Grant scientific progress, financial, and final research reports are reviewed by Komen annually and may be modified by Komen at any time. Komen will provide notification to Grantees of any changes in reporting requirements prior to reporting due dates. Grantees are responsible for reviewing and complying with all reporting requirements in effect at the time reports are due. 5.1 Online Report Submission All scientific progress, financial, and final research reports must be uploaded to PC using the appropriate templates, which can be found under the Award Details/Deliverables screen in PC. Policies and Procedures Page 7 of 26 Issue Date: May 9, 2012

8 5.2 Annual Scientific Progress Reports Grantees are required to submit annual scientific progress reports that detail the research progress, challenges and their remedy, research outcomes, and inventions occurring during the reporting period. An annual scientific progress report is due on each anniversary of the Grant start date for the duration of the project, except for the final year of the Grant when a final research report is due (see Section 5.3 Final Research Report). An annual scientific progress report may also be required if a Grantee submits a change request form for a particular change, like a final year no cost extension request. The required content of the annual scientific progress report is detailed in the table below. ANNUAL SCIENTIFIC PROGRESS REPORTS MUST INCLUDE THE FOLLOWING: Hypothesis & Specific Aims Research Outcome Highlights Publications, Presentations & Posters The overall hypothesis of the entire project should be restated along with each specific aim in the Research Plan. A description of progress made during the reporting period for each aim, data supporting the described progress, justification for delays, the projected completion date for research addressing the specific aim, and current status. Justification and approval by Komen is required prior to implementation of any changes to the research design or specific aims and must be submitted for approval using the Change of Research Plan request form in PC. A brief, bulleted description of progress made toward each specific aim. A list of the research accomplishments during the reporting period. A list of all manuscripts submitted during the reporting period that are related to the research project, in press or published, with full publication information. A list of all posters or presentations displayed or presented at scientific meetings during the reporting period in connection with the project. Patents, Products, Copyrights & Intellectual Property Professional Awards & Promotions Other Sources of Financial Support Affirmation A list of all patents or patent applications filed during the reporting period as required under Section 9. A list of the specific research products developed during the reporting period. Examples of products include novel therapeutic targets, biomarkers, vectors, novel therapies, risk assessment tools and/or algorithms, new technologies, educational materials, etc. A list of all professional awards and promotions received by any of the key personnel during the reporting period. A list of any new or pending funding sources that occurred in the reporting period or were not indicated in the last report. Upon completion, the scientific progress report should be signed by the PI, Co-PI, and Mentor of Grantee Institution as affirmation that the report has been reviewed and approved. Upon execution, the report should be uploaded to PC. Policies and Procedures Page 8 of 26 Issue Date: May 9, 2012

9 5.3 Final Research Report A final research report must be provided within thirty (30) days after the end date or early termination of the Grant term and must include all items specified in the table below. THE FINAL RESEARCH REPORT MUST INCLUDE THE FOLLOWING: Hypothesis & Specific Aims Research Outcomes Research Conclusions The overall hypothesis of the entire project should be restated along with each specific aim in the Research Plan. A description of progress made during the reporting period for each aim, data supporting the described progress, justification for delays, the projected completion date for research addressing the specific aim, and current status. A brief, bulleted description of progress made toward each specific aim. A list of the research accomplishments during the reporting period. A brief narrative followed by a bulleted or numbered list of the key outcomes, research accomplishments and conclusions for the research project. A brief description of the future prospects or next steps in this line of inquiry. A summary evaluating the impact of Komen funding on this research. For a training grant, indicate how the funding received from Komen impacted the career of the PI. Publications, Presentations & Posters A list of all manuscripts submitted during the reporting period in connection with the project, in press or published, with full publication information. A list of all posters or presentations displayed or presented at scientific meetings during the reporting period in connection with the project. Patents, Products, Copyrights & Intellectual Property Professional Awards & Promotions Affirmation A list of all patents or patent applications filed during the reporting period as required under Section 9. A list of the specific research products developed during the reporting period. Examples of products include novel therapeutic targets, biomarkers, vectors, novel therapies, risk assessment tools and/or algorithms, new technologies, educational materials, etc. A list of all professional awards and promotions received by any of the key personnel during the reporting period. Upon completion, the final research report should be signed by the PI, Co-PI, and Mentor of Grantee Institution as affirmation that the report has been reviewed and approved. Upon execution, the report should be uploaded to PC. Policies and Procedures Page 9 of 26 Issue Date: May 9, 2012

10 5.4 Financial Reports Grantee is required to submit annual financial reports that detail Grantee s expenditures during the reporting period. All expenditures must be reported in United States dollars ($USD). Grantee must submit a Request for Budget Change form in PC in the event Grantee wishes to move funds across budget categories in excess of the allowable limits (see Section 7.4 Re-budgeting of Funds). Annual financial reports are due no later than thirty (30) days after each anniversary of the Grant start date for the duration of the Grant term, except for the final year of the Grant when a final financial report is due. The date for submission of the annual financial report is intentionally set for thirty (30) days after the due date for the progress report (which is due on each twelve (12)-month anniversary of the Grant). This allows time for the compilation of financial data to ensure that reported expenditures reflect a full twelve (12) months of activity. A final financial report is due and all unexpended funds must be remitted to Komen within sixty (60) days after the Grant end date or termination. FINANCIAL REPORTS SHOULD INCLUDE THE FOLLOWING: Awarded Budget: Budget dollars by category awarded for each year (twelve (12)-month period) of the Grant. The awarded budget is automatically inserted into the PC Grant budget at the time of award and may not be modified. Current Year Budget: Budget dollars, by category, available for the current year of the Grant. The current year budget is automatically calculated based on the awarded dollars for that year and approved carry forward dollars from the prior year. Grantee may adjust allocations across budget categories within re-budgeting limits as described in Section 7.4 Re-budgeting of Funds. Expenditures: Actual dollars expended during the reporting period, by category. Unexpended funds are automatically calculated from the current year s budget and expenditures and may not be modified. Final year unexpended funds may not be carried forward to the next year s budget. Any unexpended balance at the end of the Grant must be remitted to Komen. Justifications: Are required for all categories except for indirect costs (which shall not exceed 25% as indicated under Section 6.6) and categories where no money has been budgeted or spent. They should briefly describe the nature of costs and especially detail if there are variances between the current year s budget and actual expenditures. Affirmation: Signature of the PI and ASO of Grantee Institution that the report has been reviewed and approved. 5.5 Other Reports and Engagements With reasonable prior notice to a Grantee, Komen may require additional reporting from the Grantee and also may require the Grantee to participate in site visits, telephone conferences, presentations, other speaking engagements or other activities. In such cases, Komen shall use good faith efforts to accommodate the Grantee s scheduling conflicts. A Komen Grants Administrator will assist the PI, Co-PI, and Mentor, as applicable, in scheduling any travel arrangements or meetings as necessary. Policies and Procedures Page 10 of 26 Issue Date: May 9, 2012

11 5.6 Non-Confidential Nature of Reports Scientific progress, financial, and final research reports are not considered confidential. Komen may contract with third parties who have the necessary expertise to review the reports and evaluate the progress of the project. Further, Komen may share Grant information with donors who have provided financial support for Komen research. Komen will not be responsible for any damages resulting from the disclosure of the content of the reports to such third parties. In limited cases in which information provided in a report must be kept confidential, such as information the public disclosure of which may result in a waiver to obtain a patent, Grantees must contact their Komen Science Managers and must clearly identify and mark as Confidential only the specific information that requires confidential treatment in the report provided to Komen. 5.7 Timely Submission of Reports Failure to provide timely and complete reports will constitute an event of default of the Grant Agreement, which at Komen s sole discretion may result in, among other things, the early termination of the Grant, reimbursement to Komen of expended and unexpended Grant funds, and preclude the PI, Co-PIs, Mentor and/or Grantee Institution from applying for and/or receiving future Komen funding for a specified period of time or indefinitely. 6. FUNDING AND PAYMENTS 6.1 Duration The project will be supported for the number of months reflected in the Grant Agreement. 6.2 Consortia and/or Subcontracts Upon prior written approval of Komen, a Grantee may subcontract with a third party to assist with a project by establishing a consortium or subcontract agreement whereby a research project is carried out by the Grantee and one or more other organizations that are separate legal entities. In this arrangement, the Grantee contracts for the performance of a portion of the activities to be conducted under the Grant. These agreements involve a specific percent of effort from the consortium s or subcontracting organization s principal investigator and a categorical breakdown of costs, including all budget categories of the original Grant (salaries and wages, other personnel, fringe benefits, supplies, equipment, patient care costs, travel, other expenses, subtotal direct costs, and indirect allocation). A budget of all consortium and subcontract costs must be submitted and annual expenditures against the consortium or subcontract budget must be provided with the Grantee s financial reports. Subcontractors or consortia members may not use any funds to pay indirect costs in excess of twenty-five percent (25%) of their total direct costs. All consortia and subcontracts are subject to and must comply with the Grant Agreement, which incorporates these Policies and Procedures, entered into between Grantee and Komen, and it is the responsibility of Grantee to ensure this compliance. 6.3 Ownership of Research Equipment Equipment costs cannot exceed thirty percent (30%) of the total direct costs. Approved equipment purchased during the term of a Komen-funded project is intended for the use of the PI, Co-PI, Mentor, staff, and any collaborators. Title of the equipment shall be vested in the Grantee Institution conducting the project. However, in the event of an approved transfer of a Grant to another institution, the equipment necessary for the continuation and success of the project may be transferred to the new institution with prior written approval from Komen. Upon completion of the project, all equipment purchased during the term of the Komen-funded project shall remain at the Grantee Institution. Policies and Procedures Page 11 of 26 Issue Date: May 9, 2012

12 6.4 Payment Schedule All Grant funds must be expended in accordance with the project s approved budget. Komen will disburse the first year s budgeted Grant funds within thirty (30) days of the effective date of the Grant. For each additional year, excluding the final year of the Grant term, Komen will disburse one hundred percent (100%) of the budgeted funds for that year after review and approval of a satisfactory and timely scientific progress report and financial report for the prior year, updated IACUC/IRB approvals (as applicable), and any other documents requested by Komen for its approval. For the final year of the Grant, Komen will disburse eighty percent (80%) of the approved budget funds after review and approval of a satisfactory scientific progress report and financial report for the prior year, and the submission of updated IACUC/IRB (as applicable), and any other documents requested by Komen for approval. The remaining twenty percent (20%) of funds will be disbursed upon receipt of a satisfactory final research report, final financial report, and any other documents required by Komen. As part of its oversight of research progress, Komen may adjust the project reporting period and associated disbursement of Grant funds at any time during the Grant term with prior written notice to Grantee. 6.5 Payment Form All Grant payments will be transmitted through Automated Clearing House (ACH) transfer to Grantee Institution s account at its financial institution, unless otherwise requested in writing. Grantee Institution will be responsible for providing Komen with accurate and complete ACH information as part of the submission of Required Documents before signing the Grant Agreement. Grantee Institution will be mailed a check in the event ACH transfer is not available. Acknowledgment of payment is not required. 6.6 Indirect Costs For Grant mechanisms that allow the inclusion of indirect costs, indirect costs may not exceed twenty-five percent (25%) of the total direct costs of the Grant across all years of the Grant. Indirect costs are all expenses not directly related to the conduct of the project, including allocated costs such as rent, utilities, etc. Subcontractors or consortia members may not use any funds to pay indirect costs in excess of twenty-five percent (25%) of their total direct costs. 6.7 Expenditures Out-of-Scope of Grant Komen will not be responsible for a) any expenditure made prior to the effective date or after the termination of the Grant, b) commitments made during the Grant term but not paid within sixty (60) days following the expiration of the Grant Agreement, c) expenditures that are not permitted as described within the RFA, or d) any expenditure that is inconsistent with the approved Research Plan and budget or that exceeds the total amount of the Grant. 6.8 Personnel Costs No personnel on the project may have a base salary above US$250,000 per year. 6.9 Audits Komen or its designated representatives shall have the right to request and receive from the Grantee Institution and PI, Co-PI and Mentor, as well as the institutions and principal investigators, co-principal investigators and mentors involved in any consortium or subcontract, copies of any and all documents and other information related to the Grant at any time during or after the term of the Grant. This right includes, but is not limited to, the right to review all financial books and records related to the Grant and to perform an audit or other accounting procedures of all expenses related directly or indirectly to the Grant. Policies and Procedures Page 12 of 26 Issue Date: May 9, 2012

13 7. CHANGES IN GRANT STATUS Unless specifically stated in the Policies and Procedures, all changes in Grant status must be submitted for prior approval by Komen using the appropriate change request form and deliverable templates found in PC under the Award Details/Deliverables screen. Depending upon the change requested, Komen may send a Grant Agreement amendment to the Grantee for signature by the PI, Co-PI, Mentor, Fellow (pre-fy12 grants), current Grantee Institution ASO, and the new Grantee Institution ASO (in the case of a transfer). Upon Grantee execution, Komen will sign and return a fully-executed copy of the amendment to the Grantee. Komen will also upload a fullyexecuted copy of the amendment to PC. Grantees are strongly encouraged to discuss any desired changes with their Komen Science Managers in advance. 7.1 Changes in Research Plan Changes in research design and/or specific aims require submission of a Change in Research Plan form and prior approval by Komen before implementation. Minor adjustments in approach do not require approval; however, they should be communicated to Komen in advance and further documented in scientific progress reports. Grantees are encouraged to discuss these changes with their Komen Science Managers prior to submitting a Change in Research Plan form. DOCUMENTATION REQUIRED FOR CHANGE OF RESEARCH PLAN: A completed Research Plan Change form must be downloaded from PC and completed by the PI and include: A description of the specific change(s) A description of the reason for the change(s) A revised project plan and timeline for all years affected by the change If the budget will change based on the requested change, Grantee must also submit a Request for Budget Change Form in addition to the Research Plan Change form. Policies and Procedures Page 13 of 26 Issue Date: May 9, 2012

14 7.2 Change of Grantee Institution Any change in a Grantee Institution requires submission of a Change of Institution Request form and prior written approval from Komen at least sixty (60) days prior to the proposed transfer of the Grant. DOCUMENTATION REQUIRED FOR CHANGE OF GRANTEE INSTITUTION: From the Principal Investigator A signed Change of Institution Request form containing: Reason for departure Plans for continuation of the project and confirmation that the transfer will not alter the project plan Effective date of transfer New institution name, address, and phone number Contact information for the Office of Research Administration/Sponsored Projects Office/ASO at the new institution An interim scientific progress report if more than six (6) months have passed since submission of the previous scientific progress report Budget for the new institution with new institution sign off From the Original Grantee Institution A letter from the original Grantee Institution relinquishing the Grant to the new institution signed by an approving ASO The date on which work ended at the original Grantee Institution Final financial report, indicating a total amount of unspent funds Completion and upload of a Cumulative Expenditures Spreadsheet, available in the Award Details/ Deliverables section of PC, which indicates a total amount of unspent funds After approval of the change of institution by Komen, a check (sent to Komen, Attn: Research Programs Administrative Assistant) or ACH deposit of any unexpended funds From the New Institution Standard Grant initiation document requirements: Verification or receipt of ACH payment information Verification or receipt of W-9 form Contact information for ASO and CFO IRB/ /IACUC approvals, as applicable Updated biosketch, reflecting location of key personnel at the new institution Budget for the remainder of funds for the Grant term. New Grantee Institution will either need to sign a Grant Amendment or a new Grant Agreement, which will reference the effective date of the transfer. Once Komen is in receipt of and has reviewed the above information and documents and has approved the Grant transfer, Komen will prepare an Amendment to the Grant Agreement, assigning the Grant, or a new Grant Agreement, to be signed by Komen, both the original and new institutions and the original and new PI, Co-PI and Mentor, as applicable. Upon Komen s receipt of an executed amendment or agreement from the new Grantee, Komen will execute the document and (i) notify the original Grantee Institution that it has fulfilled all its obligations to Komen and (ii) forward to the new Grantee Institution the funds reimbursed from the original Grantee Institution. Any additional funds that may be owed in connection with the Grant will be paid pursuant to the payment schedule referenced above under 6.4 Payment Schedule. Policies and Procedures Page 14 of 26 Issue Date: May 9, 2012

15 7.3 Change of Personnel All changes in PI, Co-PI, or Mentor (see circumstances as described below) require the submission of a Change of Personnel Request form signed by the original and new PI, Co-PI or Mentor at the Grantee Institution. Approval by Komen is contingent upon the proposed new personnel having the expertise necessary for continuation of the project, which shall be determined at Komen s sole discretion. Changes in the Mentor for a Postdoctoral Fellowship Grant will be made only under extreme circumstances (e.g., retirement, incapacity, or death of mentor). Changes in the PI (Fellow) for a Postdoctoral Fellowship are not permitted at any time during the Grant term. Changes in key personnel who dedicate ten percent (10%) or more time to a Grant also require submission of a Change of Personnel Request form. A curriculum vitae and biosketch, including other current and pending funding sources, must be provided for all new key personnel. Changes in key personnel who dedicate less than ten percent (10%) time to a Grant do not require prior approval, but notification of the change should be communicated immediately to Komen in the next annual scientific progress report. DOCUMENTATION REQUIRED FOR CHANGE OF PERSONNEL (10% OR GREATER TIME ONLY): From the Principal Investigator: A curriculum vitae and biosketch must be provided for the proposed new PI, Co-PI or Mentor Letter of support from current PI if change of personnel involves someone other than PI Letter of availability to perform and acceptance of the role from proposed PI, Co-PI or Mentor Other Sources of Financial Support document for proposed PI, Co-PI or Mentor (see template in Award Details/Deliverables screen in PC) 7.4 Re-budgeting of Funds Grantees are given discretion to move funds across budget categories within established threshold limits, as specified below, to meet specific research requirements. Changes exceeding these limits require a signed Budget Change Request form in advance of financial report submission and written approval by Komen prior to the expenditure of funds. Funds may NOT be moved across categories if the result exceeds any maximum allowable cost set for a budget line item, such as salaries/wages, equipment, or indirect costs, except under extreme circumstances, which will be reviewed on a case-by-case basis. Awards up to $450,000 total funds Grantees, at their discretion and without a formal request, may move up to five percent (5%) of total funds across budget categories within any single year of the Grant. Awards larger than $450,000 Grantees, at their discretion and without a formal request, may move up to $35,000 across budget categories within any single year of the Grant. Changes exceeding these limits require approval by Komen prior to expenditure of funds. Policies and Procedures Page 15 of 26 Issue Date: May 9, 2012

16 7.5 Carry Forward of Funds Grantees may carry forward up to twenty-five percent (25%) of total Grant funds from one Grant year to the next year without prior written approval from Komen. Upon submission of the financial report, if the amount carried forward to the next contract year is greater than twenty-five percent (25%) of the annual budget, specific written approval by Komen is required. Grantees with a carry forward equal to or greater than forty percent (40%) will be required to submit an interim financial report prior to approval of their next payment. The Komen Science Manager will determine the length of time the report is to cover and if an interim progress report should also be submitted. 7.6 Acceleration of Funding Grantees may request permission to accelerate funding of the Grant. That is, a Grantee may request to re-budget funds allocated to a later year into an earlier year. The Grantee will be required to submit via to Komen a justification for the acceleration, an interim scientific progress, an interim financial report, a proposed budget, and a proposed earlier termination date for the Grant term (if appropriate). If an earlier termination date is approved by Komen, the acceleration will result in a corresponding change to the due dates for the final financial report and possibly the final research report. DOCUMENTATION REQUIRED FOR ACCELERATION OF FUNDING REQUESTS: A Budget Change Request form must be submitted describing and attaching the following: Written justification for the acceleration of funds Proposed revised budget Interim or annual scientific progress report Interim or annual financial report Proposed earlier termination date of the Grant term, if applicable 7.7 No Cost Extensions No cost extensions ( NCE ) amend the Grant Agreement by changing the end date of the Grant, thereby extending the duration of the Agreement without providing additional funding. NCEs may be requested to accommodate leaves of absence or at the end of the final year of a Grant, in order to use funds that are unobligated and unexpended to complete the Research Plan. NCE requests must be approved by the PI, Co-PI, Mentor, if applicable, and the Grantee Institution and Komen. Only one NCE will be allowed per Grant. Extensions may not be granted for any purpose not specifically related to the approved Research Plan. Final year NCE requests must be made through PC no earlier than ninety (90) days and no less than thirty (30) days prior to the termination date referenced in the Grant Agreement and must include an annual scientific progress report and financial report. Three circumstances can result in the issuance of a NCE, in Komen s sole discretion: 1) Leave of absence Although rare, PIs or Co-PIs may need to leave their research activities for a defined period of time (e.g., pregnancy, family emergencies, visa issues, etc.) A leave of absence is granted only if the leave will not jeopardize the overall Research Plan, and the PI or Co-PI has put in place effective measures to ensure the success of the research project(s). A leave of absence NCE may not exceed six (6) months. Policies and Procedures Page 16 of 26 Issue Date: May 9, 2012

17 2) Final year extension (remaining Grant funds) A final year NCE is made at the end of the Grant when more work is required on the current Research Plan and there are funds remaining. The PI may request a NCE to complete research in the approved Research Plan, but may not extend the Grant to conduct research outside the current plan. A final year NCE may be granted for any period of time, not exceeding twelve (12) months, but may not exceed more than half the total duration of the initial Grant term. Only one final year extension will be granted per Grant. 3) Final year extension (no remaining Grant funds) a final year NCE is made at the end of the Grant when no dollars remain in the Grant. The PI may request a NCE to complete research in the approved Research Plan, but may not extend the Grant to conduct research outside the current plan or not approved by Komen. A final year NCE may be granted for any period of time, not exceeding twelve (12) months. Only one final year extension will be granted per Grant. DOCUMENTATION REQUIRED FOR NO COST EXTENSIONS: A signed NCE Request form must be submitted including: Type of extension Reason for the extension Length of requested extension Leave of absence extensions must also describe the measures put in place to ensure that the leave will not jeopardize the overall research; scientific progress report and financial report may be requested by the Komen Science Manager, especially if it has been more than six (6) months since the last report. Final year extensions must also provide an updated scientific progress report, financial report, and updated IRB and IACUC approvals, as appropriate, and include a plan for completing the remaining research during the NCE. 7.8 Early Termination by Grantee for any Reason (Except Default) Upon submission of a signed Early Termination Request letter on Grantee Institution letterhead (signed by PI, Co-PI, Mentor, as applicable, and ASO), a Grantee may terminate a Grant early and return all unexpended funds. A final research report must be submitted within thirty (30) days. A final financial report and remittance of any unexpended funds must be submitted within sixty (60) days after early termination. DOCUMENTATION REQUIRED FOR EARLY TERMINATION BY GRANTEE: Signed Early Termination Request letter, including Grant number and title, reason for termination and requested termination date Final research progress report Final financial report 7.9 Early Termination Initiated by Komen Komen may terminate a Grant early for actual or anticipated breach of contract obligations, including but not limited to performance failures detailed in Section 4 of the Grant Agreement. The final progress report must be submitted thirty (30) days after early termination date, and the final financial report and unexpended funds must be submitted within sixty (60) days after the early termination date. Policies and Procedures Page 17 of 26 Issue Date: May 9, 2012

18 8. PUBLICATIONS AND KOMEN LICENSED MARKS Komen may release information regarding the Grant, including pictures of the PI, Co-PI and Mentor, as well as the research summaries, scientific progress and final reports, to the general public and news media. Grantee shall ensure that Grantee has the authority to grant Komen the right to publish the works and photographs related to the project. Grantees are encouraged to publish the results derived from their Komen-funded research project. At all times during the Grant term, Grantee is responsible for ensuring that Komen is notified immediately upon the acceptance of a manuscript for publication and all final peer-reviewed manuscripts are submitted and posted to PubMed Central, where they will be made available to the public without charge. Upon availability, Grantee must provide a PubMed ID number and upload an electronic copy of all project publications to their Award Details/ Deliverables screen in PC. Grantee Institution must acknowledge Komen as a funding source on all publications and in all presentations related to the project in a clear, unambiguous, and readily-identifiable fashion, using the following acknowledgment: This research was supported by a grant from Susan G. Komen for the Cure or as otherwise directed by Komen. Komen reserves the right to offer grant-naming opportunities to donors and corporate partners, and depending on the Grant awarded, Grantees may be required also to acknowledge such donors or partners. Komen shall grant to Grantee Institution a limited, non-exclusive license to use the Susan G. Komen for the Cure name and signature logo (the Licensed Marks ) solely for the purpose of acknowledging Komen s funding of the project. Komen shall retain all right, title and interest in and to the Licensed Marks, all of which shall remain the exclusive property of Komen. All use of the Licensed Marks shall be in accordance with, and subject to, Komen s quality control and standard trademark guidelines, which are located at Upon Grantee Institution s request, Komen will provide Grantee Institution with camera-ready artwork of the Licensed Marks. Grantee Institution shall return such artwork to Komen upon completion of the project or earlier, at Komen s request. Grantee Institution will present to Komen, prior to printing, distribution, publication, display or use, any and all promotional materials, publications, articles, pictures, press releases and scripts of all statements, oral or written, to be made by Grantee Institution, PI, Co-PI or Mentor or their agents or spokespersons, which use or refer to the Licensed Marks. Such materials and statements must reference the Licensed Marks with a registered trademark symbol,, and must be of high quality consistent with Grantee Institution s and Komen s public image. Komen shall have approval rights with respect to the use of the Licensed Marks in the materials and statements submitted by Grantee Institution. Additionally, Komen may require, at its sole discretion, the removal of the Licensed Marks from any of the materials and statements at any time during the project. Grantee Institution acknowledges that Komen may implement a new branding initiative that may involve changes to the Licensed Marks. Grantee Institution and Komen shall work together in good faith to implement the new branding in connection with the acknowledgment of Komen s funding of the project. Copies of all other news releases, articles, pictures, and any and all other published material, which may be developed in connection with the project or the Grant, shall be furnished by Grantee Institution to Komen prior to publication, or as soon thereafter as practical. Policies and Procedures Page 18 of 26 Issue Date: May 9, 2012

19 9. INTELLECTUAL PROPERTIES AND ROYALTIES Discoveries, works of authorship, or inventions derived from research performed, supervised or subcontracted for by the PI, Co-PI and Mentor and Grantee Institution during the term of the Grant will be subject to Komen s Patent, Intellectual Property, and Technology Transfer Policy as set forth below: The primary purpose of Komen in funding scientifically meritorious research is to advance its mission to end breast cancer forever. Komen recognizes, however, that Inventions (as defined below) having public health, scientific, business, or commercial application or value may be made in the course of research supported by Komen. It is the desire of Komen that such Inventions will be administered in such a manner that they are brought into public use at the earliest possible time. Komen recognizes that this may be best accomplished through the filing of applications for registration of patents and/or copyrights in such Inventions and the commercial licensing of such Inventions to third parties. Invention is any discovery, data, material, method, process, device, product, program, software, proprietary know-how or other work of authorship, whether or not patentable or copyrightable, that is created, conceived or discovered in the course of research supported in whole or in part by Komen, or that arises from research supported in whole or in part by Komen. All Inventions shall be reported to Komen in writing within three (3) months after their conception or discovery. In the event that the Grantee Institution/Inventor desires to file a patent or copyright application or assert any intellectual property right in the Invention, such Grantee Institution and Inventor shall notify Komen immediately in writing and, upon Komen s request, shall provide Komen with all documentation relating to the filing or assertion of rights. Komen shall agree to maintain the confidentiality of such documentation by executing a confidentiality agreement mutually agreed to by the Grantee Institution/Inventor and Komen. In the event that the Grantee Institution/Inventor contemplates entering into a license, lease, sale, assignment or revenue-generating agreement relating to the Invention (collectively, a Commercialization Agreement ), any such Commercialization Agreement shall be reviewed by Komen. To the extent such agreement names Komen as a party or otherwise subjects Komen to potential liabilities or responsibilities, such agreement shall be approved by Komen prior to execution. If the Grantee Institution has an established and applicable patent, intellectual property, or technology transfer policy, and procedure for administering Inventions, Komen will defer to that policy with the following restrictions: Komen shall be granted the non-exclusive, royalty-free license to practice the Invention for non-commercial research purposes. This license will be subject to any restrictions on use or other limitations set forth in any Commercialization Agreement entered into by Grantee Institution/Inventor. Komen shall participate in the income (net of any direct out-of-pocket patenting or licensing costs) derived from the Invention, unless Komen waives such right in writing. If Komen elects to participate in the net income, the amount of Komen s sharing of net income shall be directly proportionate to Komen s proportion of support for the research giving rise to the Invention, but in no event shall exceed fifty percent (50%) of the total net income earned. Komen waives receipt of any income until the net income from the Invention exceeds $250, No patent or patent application, copyright or other intellectual property right will be abandoned without prior notification to Komen and without giving Komen the opportunity to take title to the Invention to the extent permitted by law. The Grantee Institution/Inventor, when it licenses an Invention to another party for commercialization, shall include provisions in the Commercialization Agreement obligating the licensee to commercialize the Invention in a Policies and Procedures Page 19 of 26 Issue Date: May 9, 2012

20 diligent manner and include appropriate diligence requirements and milestones, and shall monitor performance of the licensee. Unless otherwise agreed by Komen in writing, the Grantee Institution/Inventor shall agree that: (a) if it or its licensee has not taken effective steps within three (3) years (or whatever is a reasonable longer time in the circumstances) after issuance of a patent or a clear determination of commercial value in an Invention that is being administered by the Grantee Institution/Inventor, whichever occurs first, to bring the Invention to practical or commercial application through licensing or otherwise on terms that are reasonable in the circumstances; and (b) if it or its licensee cannot show reasonable cause why it or its licensee should retain title to and all rights in the administration of the Invention for a further period of time, then, unless no other parties have superior rights (as provided under this Policy), Komen shall have the right to require the institution or its licensee: (i) to license (on an exclusive basis where possible) said patent or intellectual property right to Komen with the right to grant sublicenses; (ii) to cancel any outstanding exclusive licenses; (iii) to grant licenses under said patent or intellectual property right on a non-exclusive, royalty-free basis or on such other terms that are reasonable in the circumstances to third parties; and/or (iv) to compel such other reasonable disposition of the Invention rights as may be mutually agreed upon in writing by Komen and the Grantee institution and/or its licensees. If the Grantee Institution has no established and applicable patent, intellectual property, or technology transfer policy, and procedure for administering Inventions, Komen shall have the sole right to determine the disposition of the Invention rights in a manner consistent with this Policy. In such cases, Komen may, in its sole discretion, elect to do one or more of the following: a) Have a patent and/or copyright application filed, and decide to whom it shall be assigned. In such case, the Institution and Inventor shall execute all documents necessary to assist in the filings and the assignment; b) Decide that patent or copyright should be or not be filed; c) Release the Invention to the Inventor or Inventor s designee; d) Submit the Invention to a qualified organization for administration and licensing; e) Determine by negotiation the fair share of royalty income to be paid to the Inventor, the Grantee Institution, Komen, and any other parties who contributed funds that supported the Invention; or f) License or make other arrangements for the application and use of the Invention on an exclusive or nonexclusive, royalty-free basis as seems reasonable in the circumstances. Notwithstanding any other provisions of this policy, if an Invention is derived from research funded by the joint support of Komen and an agency or department of the United States government, Komen shall defer to the patent, intellectual property, or technology transfer policy of that agency or department upon receipt of a written statement by the appropriate agency or department notifying Komen of its policy and procedure and identifying the rights and interests of Komen in the Invention. If any Invention is funded by the joint support of Komen and a health agency or funding organization, other than an agency or department of the United States government, and that other agency or organization has an intellectual property policy that conflicts with Komen s policy, the other agency/organization, the Inventor, the Institution, and Komen shall negotiate in good faith a mutually satisfactory disposition of the Invention rights. The right of Komen to participate in revenue derived from an Invention may only be waived in writing, and no provision of these Policies and Procedures shall constitute such a waiver. Policies and Procedures Page 20 of 26 Issue Date: May 9, 2012

21 APPENDIX A GRANT AGREEMENT FOR RESEARCH AND TRAINING GRANTS Policies and Procedures Page 21 of 26 Issue Date: May 9, 2012