MASTER SERVICE Agreement

1601 Fifth Ave.

Suite 1000

Seattle, WA 98101

MASTER SERVICE Agreement

between

QUORUM REVIEW

and [INSTITUTION]

THIS AGREEMENT FOR SERVICES (“Agreement”), effective ______(the “Effective Date”), is made by and between Quorum Review, Inc., a Washington corporation with its principal place of business at 1601 Fifth Avenue, Suite 1000, Seattle, Washington 98101, (hereinafter “Quorum”), and [Institution] a [state] corporation, with its principal place of business at _____ (hereinafter “Institution”).

WITNESSETH

WHEREAS, Institution desires to obtain institutional review board (IRB) oversight services for certain research studies involving non-exempt human subjects research; and

WHEREAS, Quorum is willing to provide such services upon the terms and conditions set forth herein;

NOW THEREFORE, the parties do agree as follows:

1. QUORUM’S RESPONSIBILITIES

A.  New Research Studies. Quorum agrees to assume IRB oversight responsibility and to perform IRB functions in compliance with applicable federal and state regulations for certain new research studies involving human subject research to be conducted at Institution. Quorum’s services shall include, but not be limited to: review and approval or disapproval of new protocols; review and approval, disapproval or modification of consent forms; review and approval or disapproval of the investigator(s); collection of reports of unanticipated problems; and maintenance of required IRB records pursuant to 21 CFR § 56.115 and 45 CFR § 46.115. Quorum shall conduct continuing review of certain new research studies appropriate to the degree of risk in such studies. Quorum agrees to conduct at least an annual review of each study.

B. Quorum’s Primary Duty. As set forth in 21 CFR § 56.102(g) and 45 CFR §§ 46.102(g), 46.109 and 46.111, Quorum’s primary duty is to protect the rights and welfare of “human subjects,” a term defined by 21 CFR § 56.102(e) and 45 CFR §46.102(f). Nothing in this Agreement will be construed to limit Quorum’s independence to take actions necessary to protect the rights and welfare of human subjects, or to alter Quorum’s primary duty to human subjects.

C. Compliance with Applicable Laws and Regulations. Quorum shall perform the services hereunder in compliance with applicable federal and state laws and regulations governing IRBs and research with human beings, including the United States Food and Drug Administration (“FDA”) Regulations 21 CFR Parts 50 and 56 and the United States Department of Health and Human Services (“DHHS”) Regulations 45 CFR Part 46.

D. Notification Requirements. Quorum will promptly notify Institution of any (i) unanticipated problems involving risks to subjects or others, (ii) serious or continuing noncompliance with pertinent Regulations or Board determinations, (iii) suspension or termination of Board’s approval of the Study or (iv) other issues as requested by Institution. Relevant minutes of Board meetings may be made available to Institution by Quorum upon request.

E. Insurance. Quorum will provide at its expense, and maintain throughout the term of this Agreement, professional liability coverage in an amount no less than $1,000,000 each claim/$3,000,000 annual aggregate; general liability coverage in an amount no less than $1,000,000 each claim/$3,000,000 annual aggregate, and officer and director liability coverage in an amount no less than $1,000,000 each claim/$3,000,000 annual aggregate. Upon request, Quorum agrees to provide Institution with Certificates of Insurance demonstrating this coverage.

2. RESPONSIBILITIES OF INSTITUTION

A. General. Institution agrees that Quorum shall be one of its IRBs of record. Institution agrees to facilitate Quorum access to Institution expertise when needed for IRB review. In keeping with the requirements of 21 CFR § 56.112, Institution cannot approve any research study that has been disapproved by Quorum. Institution may, however, disapprove any study approved by Quorum. Institution agrees to abide by the decisions of Quorum and shall use its best efforts to ensure that the clinical research performed by Institution shall be conducted in accordance with those decisions.

B. Investigators and Staff. Institution shall ensure that the investigators and other staff at Institution who are conducting studies under Quorum review are appropriately qualified and meet Institution’s standards for eligibility to conduct research. Institution shall ensure that investigators conducting research at Institution receive proper initial and continuing education on the requirements related to human subject protection.

C.  Review of Clinical Trial Agreements (CTA). Institution shall ensure that the Clinical Trials Agreement (CTA), if any, and the approved consent form do not conflict with each other regarding the compensation for injury. Institution will inform Quorum of its procedures to resolve such conflicts upon request. In the event of a conflict between the CTA and the consent form, the research will not commence until the conflict is resolved in a way acceptable to Institution and Quorum.

D. Notification Requirements. Institution agrees to notify Quorum of all communications to and from the FDA, OHRP and/or other applicable federal and state regulatory agencies regarding the studies that have been referred to Quorum. Institution also agrees to notify Quorum of any related IRB matters concerning investigators who have submitted studies to Quorum for review.

E. Research Submission Requirements. Institution will notify Quorum of any research requiring Quorum’s review, and will follow Quorum’s standard submission requirements to initiate the review process and/or transfer studies to Quorum. Each Study shall be submitted to Quorum with an accompanying “Institution Cover Page” in substantially the form as set forth in Exhibit A, attached hereto and incorporated herein by reference. Also, an Institutional Waiver Form shall be submitted for each Study with the box indicating the existence of this Agreement marked appropriately (form available from http://www.quorumreview.com).

F.  Insurance. Institution will provide at its expense, and maintain throughout the term of this Agreement, comprehensive professional, general, and officer and director liability coverage in amounts no less than specified in Section 1(E) of this Agreement. Upon request, Institution agrees to provide Quorum with Certificates of Insurance demonstrating this coverage

3. CONFIDENTIALITY

A. Definitions. For purposes of this Agreement, the party that transmits Information shall be referred to as the “Discloser,” and the party to which Information is transmitted shall be referred to as the “Recipient.” The term “Confidential Information” shall mean any and all information disclosed by the Discloser to the Recipient, or to any of its agents, affiliates, officers, directors, employees and subcontractors either in oral, written or any tangible form. Confidential Information includes, but is not limited to, technical, scientific, financial, strategic, marketing or product information; practices and processes; business systems and techniques; billing practices; computer processes, programs and codes; forms; and production processes.

B. Non-Disclosure and Non-Use. Recipient shall hold in confidence any and all Confidential Information revealed by the Discloser or with which it became acquainted within the framework of this Agreement, and shall not use or disclose Confidential Information to any person or entity, except (i) to such of its own employees, independent contractors and representatives in the course of providing services hereunder (ii) to authorized agents of the federal government if required for audit or regulatory purposes, and (iii) to such other recipients as the Discloser may give prior written approval; provided, however, that recipients of Confidential Information shall have first executed a confidentiality and non-use agreement with the Recipient. Each party further agrees that Confidential Information shall not be used except for the purpose of this Agreement as set forth herein.

Notwithstanding the foregoing, nothing in this Agreement shall be construed to restrict a party from disclosing Confidential Information as required by law, subpoena, court order, or other governmental order or request. Additionally, nothing in this Agreement shall restrict a party from disclosing that Quorum reviews research for the Institution.

C. Exceptions. The obligations of this Section 4 will not apply to any Confidential Information which the Recipient is able to demonstrate:

i) Was in its possession prior to being received from the Discloser and was not acquired, directly or indirectly, from the Discloser, or

ii) Was in the public domain, at the moment of being received from the Discloser, or

iii) Became part of the public domain through no fault of the Recipient, after having been so communicated, or

iv) Was lawfully received by the Recipient from some third party having a right of further disclosure, or

v)  Is required by law, regulation, rule, act or order of any governmental authority or agency to be disclosed by Recipient.

D. Ownership. Each party hereto is, and shall remain, the exclusive owner of its Confidential Information and all patents, copyright, trade secret, trademark and other intellectual property rights therein. No license or conveyance of any such rights is granted or implied under this Agreement.

E. Transmittal of Information. The parties agree that information exchanged under this Agreement, including Confidential Information, may be transmitted via facsimile or electronic mail, or sent via regular or express mail.

F. Survival of Terms. The Confidential Information provisions in this Agreement will survive the termination of this Agreement for any reason.

4. NOTICE

All notices relating to the terms of this Agreement shall be delivered personally, by facsimile, by e-mail, by registered or certified first class mail, or by overnight courier service to the contact addresses set forth below. Notice shall be effective upon receipt if personally delivered, delivered by e-mail or delivered by facsimile; upon the third business day following the date of mailing by registered or certified first class mail; or on the first business day following the date of delivery to the overnight courier. A party may change its address listed below by written notice to the other party.

If to Institution: [include information here]

If to Quorum: Quorum Review, Inc.

1601 Fifth Avenue, Suite 1000

Seattle, WA 98101

Attn: Director, Customer Relations & Marketing

5. COMPENSATION

A. IRB Review Fees. Quorum will charge for services in accordance with its published fees in effect at the time that services are rendered. For new studies submitted to Quorum, Quorum shall bill Institution, investigators or sponsors, or their agents, for services rendered as directed upon the applicable submission form(s); provided, however, that if Quorum does not receive payment within ninety (90) days of invoicing, Institution shall be responsible for payment of such services regardless of the original billing contact instruction noted in the submission form(s).

B. Institution-Sponsor Contract. Institution will use its best effort to maintain a contractual agreement with each sponsor and/or investigator in which the sponsor and/or investigator agrees to make payments as specified in this Section directly to Quorum for services rendered.

C. Survival Upon Termination. The Compensation provisions of this Agreement will survive termination of this Agreement for any reason.

6. TERM AND TERMINATION

A. The term of this Agreement shall commence upon execution of this Agreement by both parties, and shall continue until such time as either party gives sixty (60) days written notice of termination. Notwithstanding the foregoing, in the event that either party is in default in the performance of any of its obligations under this Agreement, and the default has not been remedied within thirty (30) days after the date of notice in writing of such default, the party not in default may terminate this Agreement immediately by written notice.

B. Notwithstanding the immediately preceding paragraph, the parties specifically recognize that 21 CFR § 56.109(f) requires that, “An IRB shall conduct continuing review of research . . .not less than once per year, and shall have authority to observe or have a third party observe the consent process and the research.” Therefore, termination of this Agreement shall not affect Quorum’s obligations of continuing review for studies approved hereunder or Institution’s payment responsibilities until such studies are transferred to and re-reviewed by the responsible IRB.

C. Upon termination, Quorum will continue its oversight of active studies until closure, unless otherwise mutually agreed to by the parties. If Institution requests that active studies be transferred to Institution or other IRB, an additional fee equal to Quorum’s annual continuing review fee shall be charged to Institution for each active study transferred.

7. SECURE PORTAL

Quorum maintains a secure portal (the “Portal”) accessible through the internet. Quorum receives submission documents and posts IRB correspondence via the Portal. Institution acknowledges that when Quorum grants Portal access to Institution employees or agents, Institution and those individuals will be obligated to abide by the Terms of Use set forth at http://www.quorumreview.com, including the terms relating to confidentiality, submission standards, limited license of use, warranties and disclaimers. To the extent the terms of this Agreement conflict with the provisions of the Terms of Use, this Agreement shall govern. Institution also acknowledges that it is Institution’s obligation to notify Quorum when the access of an Institution employee or agent should be disabled for any reason.

8. GOVERNING LAW

This Agreement is governed by the laws of the State of Washington without regard to such state’s conflicts of laws principles.

9. FORCE MAJEURE

No default, delay, or failure to perform on the part of either party shall be considered a default, delay, or failure to perform otherwise chargeable, hereunder, if such default, delay, or failure to perform is due to causes beyond either party’s reasonable control including, but not limited to, strike, lockouts, or inactions of governmental authorities; epidemics; war; embargoes; fire; earthquake; acts of God; or default of a common carrier. In the event of such default, delay, or failure to perform, any date or times by which either party is otherwise scheduled to perform shall be extended automatically for a period of time equal in duration to the time lost by reason of the excused default, delay, or failure to perform.

10. ASSIGNMENT

This Agreement may not be assigned or transferred by either party without the prior written consent of the other party.

11. Relationship of the Parties

Each party’s relationship with the other is and shall be that of an independent contractor, and no partnership, joint venture, co-venture, employer/employee, principal/agent, master/servant or other similar relationship is created, or intended to be created, hereby. Neither party is nor shall be the agent or employee of the other, and neither party has authority to act on behalf of the other in any matter except to the extent expressly agreed upon in writing.

12. Waiver

The failure of either party to assert a right hereunder or to insist upon compliance with any term or condition of this Agreement shall not constitute a waiver of that right or excuse a similar subsequent failure to perform any such term or condition by the other party.