Negotiations

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.

Award Notice to Execution of Agreement

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.

Listing of Clauses - Required/Preferred Language

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.

1. Legal Name / Parties to the Agreement
2. Notices
3. Indemnification
4. Insurance Requirements
5. Intellectual Property
6. Governing Law
7. Authorized Signatures
8. Period of Performance
9. Statement of Work
10. Principal Investigator / Project Director
11. Payee Information
12. Record Retention
13. Budget
14. F&A/IDC Rates
15. IRB Fees
16. Clinical Training Administrative Expenses
17. Agreements with Foreign Entities
18. Identification/Assurance Numbers
19. Incorporation of Other Documents by Reference
20. Changes/Rebudgeting
21. Publications
22. Termination Clause
23. Patents
24. Mediation/Arbitration/Dispute
25. Debarment
26. Confidentiality
27. Independent Contractor
28. Order of Precedence
29. Execution of the Agreement

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:

Eastern Virginia Medical School, located at 358 Mowbray Arch, PO Box 1980, Norfolk, VA 23501-1980 ("Institution").

If there are EVMS Health Services employees involved in the project, then we also need to include:

"EVMS Academic Physicians and Surgeons Health Services Foundation whose business address is 4111 Monarch Way, Suite 500, Norfolk, Virginia 23508, (hereinafter collectively referred to as "EVMS")."

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:

"This project will be performed at Eastern Virginia Medical School's Strelitz Diabetes Center…"

"With the study being performed by Dr. John Doe as its principal investigator, ("Investigator")…"

The "Parties" of the agreement must be listed consistently throughout the agreement. (Sponsor, Company, Institution, Principal Investigator, etc.)

Notices

The Notices section of the agreement must list EVMS Office of Sponsored Programs and EVMS Health Services (as applicable) as shown below:

and to

Indemnification

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.

1. Standard Language
   
   1. If the Sponsor is providing the substance being tested or providing the protocol to be followed, then the Sponsor must indemnify EVMS from any liability for its use and provide EVMS to opportunity to approve any settlement on our behalf. The sponsor should include language that will "indemnify EVMS and the PI against all losses, including attorney fees, resulting from personal injury claims arising out of performance of the agreement."
   2. The agreement must also contain the EVMS standard language:
      
      "The Sponsor shall not compromise or settle in the name of Eastern Virginia Medical School without the prior written consent and approval of its Vice President of Administration and Finance. The Sponsor shall not compromise or settle in the name of EVMS Academic Physicians and Surgeons Health Services Foundation without the prior written consent and approval of its Chief Executive Officer. Nothing in this agreement is meant to waive a defense of immunity for Eastern Virginia Medical School or EVMS Academic Physicians and Surgeons Health Services Foundation to which it may be entitled."
      
      By including this language, a Sponsor cannot compromise or settle on behalf of EVMS without EVMS' written consent.
   3. If the protocol is EVMS Investigator-Initiated, then EVMS may be required to indemnify the Sponsor from any liability.
2. Controlling the Defense
   
   1. If the Sponsor insists on controlling the defense of any claim, OSP initiates the Supplemental Information for Sponsored Agreement Negotiation Form (E-4) and forwards it to the PI's department chair for completion. The chair must determine whether the project is judged as low risk or greater than low risk.
   2. If judged as low risk, OSP can accept language that allows the sponsor to control the defense as long as certain criteria are met and with the consent of EVMS' General Counsel.
   3. If judged as greater than low risk, EVMS will not accept language giving the Sponsor control of the defense. This may cause an impasse in the negotiations of the agreement. OSP will work with EVMS' General Counsel to develop and propose alternate language which will secure protection for EVMS and satisfy the Sponsor's concerns. The PI and the department chair will be kept informed of the progress of these negotiations.
      
      Note: The Supplemental Information for Sponsored Agreement Negotiation Form (E-4) may also be needed if the sponsor will not accept EVMS' required indemnification language.
3. Additional Information
   
   1. As an alternative, each party may provide mutual indemnification for their own negligent acts or omissions and willful misconduct. If mutual indemnification cannot be provided, depending on the project at hand, EVMS may agree to remain silent. If silent, no subrogation must be included (right of insurance company to sue sponsor); we must retain the ability to seek redress.
   2. If we are agreeing to remain silent on Governing Law, then the indemnification should include "applicable laws, regulations, and standards, as defined in the locale where the study is taking place."
   3. Clinical Trials - EVMS will indemnify for its own negligence/ willful misconduct, actions contrary to protocol, unauthorized warranties concerning the study drug, and failure to obtain appropriate informed consent.
   4. EVMS cannot indemnify the state, city or a federal entity, including the Navy, Army, Air Force or Marines.

Insurance Requirements

Acceptable insurance requirements are as follows:

"EVMS represents and warrants that it possesses and will carry at its own expense commercial general liability insurance with limits of not less than $1,000,000 per occurrence and $3,000,000 in the annual aggregate, which covers employees of EVMS for claims for bodily injury or death, or for property damage, due to alleged errors or omissions or negligent acts relating to the performance of professional services to be provided under this agreement."

Or…"maintained at levels reasonable and customary to support the obligations assumed herein."

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."

Occurrence policy: Claim is made back to policy in effect when event occurred.

Claims-made policy (type EVMS has): Claim is made against policy in effect when claim is made, not when the event occurred.

Intellectual Property

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.

"It is recognized and understood that the existing inventions and technologies of Sponsor or Institution are their separate property, respectively, and are not affected by this Agreement or a Protocol Agreement (including, but not limited to, the Sponsor study drug, and information and technology relating to the protocol) and neither party shall have any claims to or rights in such existing inventions and technologies of the other party. Title to any inventions or discoveries arising from a Study and conceived and reduced to practice solely by Institution employees and not from Sponsor confidential information, shall be owned by the Institution and shall be promptly disclosed in writing to Sponsor. The Institution will offer Sponsor the first opportunity to enter into a royalty-bearing license for Institution's rights in such invention or discovery. Such license shall be exclusive and worldwide to the maximum extent permitted by the established policy of Institution with a reasonable royalty and will provide Sponsor with an exclusive right to make, have made, use, sell and offer for sale such invention or discovery and the right to sublicense."

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.

Governing Law

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).

If SILENT of Governing Law: INDEMNIFICATION should be "as defined in the locale where the study is taking place."

Authorized Signatures

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.

Period of Performance

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.

Statement of Work

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 Information

Payee language should read as follows:

"Payments should be made payable to Eastern Virginia Medical School, and be sent to: EVMS, Office of Sponsored Programs, P.O. Box 1980, Norfolk, VA 23501-1980."

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.

Record Retention

EVMS preference is to follow NIH standard requirements of three years:

"Financial records must be retained for a period of three years after the final Financial Status Report (FSR) or SF 269 is submitted."

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.

Budget

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:

• Organized Research consists of Bench Work, Lab Work and Animal Studies, etc.
• Other Sponsored Activities consists of Clinical Research, Patient Studies, Community Programs, Questionnaires, and Use of Office only - not Labs.
• Off-Campus Definition: For all activities performed in facilities not owned by the Institution and to which rent is directly allocated to the project(s), the off-campus rate will apply. Actual costs will be apportioned between on-campus and off-campus components as necessary. Each portion will bear the appropriate rate. (EVMS Rate Agreement, dated 4/12/07)

IRB Fees

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

"In addition, by signing this agreement, parties certify and provide that assurances regarding Age Discrimination, Civil Rights, Debarment and Suspension, Delinquent Federal Debt, Drug-Free Workplace, Handicapped Individuals, Lobbying, and Gender Discrimination are on file with PHS or will be made available upon request."

"By signing this agreement, the parties hereby accept and certify compliance with: (1) the EVMS scientific misconduct policy; (2) the EVMS IRB policies and procedures; (3)45 CFR 160; (4) 45 CFR 164; (5) the HIPPA of 1996; (6) the Drug-Free Workplace Act of 1988 for Grantees as Individuals; and, (7) warrant that they have not been and are not currently listed on the FDA disbarment list and will notify EVMS if they become listed."

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.

Publications

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.

Termination Clause

Language must include 30 days notice to terminate agreement and to cover early termination expenses/study start-up costs expended to date of termination.

"Sponsor will reimburse the Institution for all study start-up costs expended to date of termination as specified and all non-cancelable obligations incurred prior to termination, upon early termination of the study."

Patents

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.

Debarment

The agreement should only warrant past and present debarment. We cannot warrant what may happen in the future.

Confidentiality

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.

Independent Contractor

Be sure that the relationship between the parties (EVMS and Company/Sponsor) is that of Independent Contractor, not employee.

Order of Precedence

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

By: _______________________________________
Helen S. Heselius, CPA Date
Director of Finance

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:

Read and Accepted by:

__________________________________________
John Doe, M.D., Ph.D. Date
Principal Investigator

As required, when EVMS Health Services is included as a party to the agreement:

EVMS ACADEMIC PHYSICIANS AND SURGEONS HEALTH SERVICES FOUNDATION

By: _______________________________________
James F. Lind, CEO Date
EVMS Academic and Physicians Health Services Foundation

As required, when Sentara is included as a party to the agreement:

SENTARA HOSPITALS D.B.A. SENTARA NORFOLK GENERAL HOSPITAL

By: _______________________________________
Robert Hoefer Date
Vice President, Support Services, Sentara Norfolk
General Hospital

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