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EVMS Office of Sponsored Programs is tasked with the responsibility for negotiating terms and conditions of grants and agreements on behalf of EVMS. These negotiations are performed by OSP staff. There are several terms and conditions that OSP will request that the Sponsor include in agreements. Sometimes Sponsors readily accept these terms and conditions, and sometimes they do not. When they don't, the process may take longer. When Pharmaceutical Sponsors use a Clinical/Contract Research Organization (CRO) to manage the clinical trial, the negotiation process may be further delayed, as OSP must go through the CRO to get concurrence from the Sponsor. It is the goal of OSP to complete the negotiation process within three weeks' time. This, of course, is dependent on the Sponsor's availability to the CRO, if applicable, the Sponsor's required review process and their acceptance of any requested revisions. OSP records all contacts made with the Sponsor, either through the CRO or directly, and maintains this record for all agreements in negotiations. These records are available for review. The following list of explanations/preferred language is provided for reference and so that PIs and departmental administrators can see what OSP looks for in their review. OSP uses the following template for all agreements. This maintains consistency in OSP reviews. The language below is the preferred language or an explanation of the clause. Asking the initiating party to send you an electronic copy of the agreement greatly facilitates the review and revision process. Each award signed represents EVMS and must be done in a professional manner.
Of all the primary terms above, the Indemnification clause is the one most often to cause delays in the Sponsor and EVMS coming to an agreement. OSP will work to minimize these delays by knowing what repeat Sponsors have agreed to on past agreements and addressing these concerns early in the proposal process. As an exception and based on the project at hand, EVMS may agree to accept alternate language in agreements. The time to address accepting alternate language is at the beginning of the proposal process, when time is not critical. Legal Name/Parties to the Agreement EVMS must be listed as the party to the agreement. The correct listing is:
If there are EVMS Health Services employees involved in the project, then we also need to include:
If work is performed at the hospital and Sentara requests to be named as a party to the agreement, "Sentara Hospitals d.b.a. Sentara Norfolk General Hospital" is used and Sentara representatives will also sign the agreement. A similar relationship may exist with other hospital affiliates if required. Because EVMS is responsible for the award, the parties named in the agreement must be the Sponsor and Eastern Virginia Medical School (and EVMS Health Services as required), not the individual department. The principal investigator is a party to the agreement only through EVMS. Acceptable additional wording would be:
The "Parties" of the agreement must be listed consistently throughout the agreement. (Sponsor, Company, Institution, Principal Investigator, etc.) The Notices section of the agreement must list EVMS Office of Sponsored Programs and EVMS Health Services (as applicable) as shown below: Eastern Virginia Medical School and to EVMS Academic Physicians Indemnification clauses must protect the PI and EVMS from liability from claims made by study subjects. The determination of the risk involved in a key component in negotiating the terms of this clause.
Insurance Requirements Acceptable insurance requirements are as follows:
30-day prior notice: EVMS cannot insure compliance with the "30-day prior" notice of cancellation requirement often written in agreements. Alternate language - "reasonable efforts will be made to notify Sponsor prior to any substantive changes to the above required coverage." Intellectual property requirements must be within EVMS guidelines for protection of possible patents and licenses. EVMS standard language is shown below. Any language contrary to this requires review and approval of the EVMS Intellectual Property Office.
For Non-Pharmaceutical Sponsors: The ownership of any inventions developed with the resources, personnel and facilities of EVMS must be offered first to EVMS. The agreement may contain acceptable language relating to "yours, mine, and ours" regarding inventions which are developed solely by the sponsor, solely by EVMS, and jointly by the sponsor and EVMS. For Pharmaceutical Sponsors: Usually the Sponsor retains title. However, the Sponsor's title must be limited to IP arising from the Study, not "all works copyrighted by EVMS." Existing EVMS inventions and technologies should not be affected. EVMS accepts governing law of the Commonwealth of Virginia. The clause might read, "The laws and courts of the Commonwealth of Virginia shall govern the agreement." The other option to is to remain silent (remove the clause from the agreement). The Director of Finance, as delegated from the Vice President of Administration and Finance, has the authority to sign agreements on behalf of EVMS. The CEO of EVMS Health Services has authority to sign agreements on behalf of EVMS Academic Physicians and Surgeons Health Services Foundation. Principal Investigators may provide an additional "Read and Accepted By" signature on agreements, in which they are acknowledging that they have read and accepted the requirements by which they must administer the project and agree to any confidentiality requirements, but they do not have authority to sign agreements on behalf of EVMS. An example of how the signatures should be presented is included below. Please contact OSP with any questions relating to authorized signatures on agreements. The start and end dates must match what was proposed or the logical follow-up to those dates. If EVMS is a second-tier awardee, the dates from the Sponsor to the first-tier awardee must cover the EVMS period of performance. Final Report due dates must be included within the end date of the award. The Attachment/Exhibit containing the SOW must be included. Principal Investigator/Project Director The PI should be EVMS faculty. If not, the "Community Faculty as PI" procedures must be followed. Please contact OSP for assistance in determining what type of agreement is required. Payee language should read as follows:
When EVMS is a sub-awardee, negotiate the submission of final invoices at 60 days (45 days minimum) after end date. Usually federal awards will give the prime 90 days, so asking for 60 days when EVMS is a sub-awardee should be acceptable. EVMS preference is to follow NIH standard requirements of three years:
However, Pharmaceutical sponsors may have longer record retention requirements that are often defined in contractual agreements and FDA review policies. It is the responsibility of the PI and Department to retain records as necessary under the terms of agreements. Review and compare the budget in the agreement with the budget proposed. Clarify any changes. Amounts included in the PAYMENTS clause of the agreement must agree with proposed amounts. Cost of Living Annual Escalation: EVMS uses the NIH standard annual cost of living increase of 3%. This should be used for all multi-year grants and should be considered as a minimum escalation for all contract budget negotiations. If you are submitting a federal grant or contract for which the start date will be in the next fiscal year (after July 1), include this escalation in your Year 1 calculations. F&A/IDC Rates Depending on the location of the project at hand, the following F&A Rates (Indirect Cost/IDC) rates should be used. These are Predetermined Rates:
The application of the Organized Research or Other Sponsored Activities rate depends on the EVMS space utilized:
IRB fees are reimbursed by the sponsor and should be included in the budget. F&A/IDC should not be applied to IRB fees. EVMS does contract certain studies with an external IRB office, Chesapeake Research Review Inc. (CRRI). CRRI review fees are higher than EVMS review fees, and CRRI charges for each additional form. These expenses should be accurately reflected in the budget. Clinical Trial Administrative Expenses Budgets for clinical trials should include startup costs and other non-refundable administrative expenses that EVMS will incur to start a clinical trial even if the study is terminated. These costs should be addressed in the Termination Clause of the agreement, including the basis of calculating reimbursements. Agreements with Foreign Entities Budgets must be written in U.S. dollars by specifically indicating USD$. The agreement should include an acceptable exchange rate [as of (date), or as of presentation] or other means of acceptable compensation. Identification/Assurance Numbers The following list is EVMS-specific. These assurance numbers should be listed as required on all proposal/budget submissions. Taxpayer's I.D. # 54-6055378 CAGE Code # 02SP5 DUN'S # 058625146 USDA Registration No. 52-R-003 DHHS Rate Agreement Date 07/29/02 IRB Identification No. 01NR NIH Entity I.D.# 1-546055378-A2 Human Subject Assurance No. FW A00003956 (as of 1/14/2003) NSF Organization Code # 0001768000 Misconduct in Science Date 03/01 (Annual) Congressional District 2nd Type of Organization Private, Nonprofit Organizational Component Code 01 Major Subdivision School of Medicine Animal Welfare Assurance No. A3012-01 Alternate Assurance Language
EEO and Animals certifications may also be applicable. Incorporation of Other Documents by Reference If the agreement references other documents, OSP must review these other documents. Some items in these documents may not be acceptable by, or applicable to, EVMS. Changes/Rebudgeting Changes in the scope of the services may be required during the course of this agreement. Such changes, including any increase or decrease in the amount of compensation which is mutually agreed upon by the parties, shall be incorporated only by written amendment to the agreement. On behalf of the Principal Investigator, EVMS maintains the right to publish information and/or results of the project subject to providing the Sponsor with the opportunity to review the publication in advance, but not requiring approval, and if necessary, to delay publication in order to protect confidentiality/patent issues. Language must include 30 days notice to terminate agreement and to cover early termination expenses/study start-up costs expended to date of termination.
Rights to inventions, improvements, and/or discoveries are negotiated on a case-by-case basis, depending on whether the Company/Sponsor or EVMS' investigator initiates the research protocol. Mediation/Arbitration Dispute Resolution EVMS prefers to remain silent on dispute resolution (remove the clause from the agreement); arbitration language is always removed from the agreement. If the other party insists on some form of resolution, EVMS will accept "mediation" language, not arbitration or adjudication. The agreement should only warrant past and present debarment. We cannot warrant what may happen in the future. Parties may have access to and become acquainted with information, data, materials, methods and processes which are owned by EVMS and/or the sponsor. Each party must acknowledge such information is confidential, and agrees not to disclose any such information directly or indirectly or use it in any way during the term of this agreement or at any time thereafter, except as required in the course of performance in accordance with this agreement or as disclosure to another health-care provider as may be required for the health and well-being of the subject. Be sure that the relationship between the parties (EVMS and Company/Sponsor) is that of Independent Contractor, not employee. The order of precedence must protect EVMS. It should include the Agreement and any amendments, any Attachments/Exhibits of the Agreement, any negotiation correspondence (email and phone notes, include names and dates), the Proposal and the RFA/announcement. EVMS' proposal should be higher in the order than the RFA/ announcement. This way, our proposal terms and conditions will take precedence if we took exception to any terms of the RFA/ announcement. Execution of the Agreement The signature of the Fiscal Officer/Administrative Official (Director of Finance) is required on each agreement as shown below: EASTERN VIRGINIA MEDICAL SCHOOL
Principal Investigators do not sign as a party to the agreement, but to indicate they have read and accepted the conditions of the agreement and agree to any confidentiality requirements. For the Principal Investigator's signature:
As required, when EVMS Health Services is included as a party to the agreement:
As required, when Sentara is included as a party to the agreement:
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| Last Updated on Thursday, 07 January 2010 13:17 |