COMMONWEAL TH OF VIRGINIA STANDARD CONTRACT

Transcription

1 COMMONWEAL TH OF VIRGINIA STANDARD CONTRACT Contract Number: VTS This contract entered into this 21st day of February 2018 by Western Institutional Review Board, Inc. hereinafter called the "Contractor" and Commonwealth of Virginia, Virginia Polytechnic Institute and State University called "Virginia Tech." WITNESSETH that the Contractor and Virginia Tech, in consideration of the mutual covenants, promises and agreements herein contained, agree as follows: SCOPE OF CONTRACT: The Contractor shall provide External Institutional Review Board Services to Virginia Tech as set forth in the Contract Documents. PERIOD OF CONTRACT: From February 21, 2018 through February 20, COMPENSATION AND METHOD OF PAYMENT: The Contractor shall be paid by Virginia Tech in accordance with the Contract Documents. CONTRACT DOCUMENTS: The Contract Documents shall consist of the Master Services Agreement dated February 21, 2018.

2 MASTER SERVICES AGREEMENT This Master Services Agreement (this "Agreement") is made and entered into as of the last date set forth on the signature page (the "Effective Date") by and between Virginia Polytechnic Institute and State University ("Virginia Tech"), an agency of the Commonwealth of Virginia with a principal place of business at Blacksburg, Virginia. ("Client") and WIRB - Copernicus Group, Inc., a Delaware corporation with a principal place of business at 212 Carnegie Center, Suite 301, Princeton, NJ ("WCG Parent"), on behalf of itself and its Affiliates ( collectively, "WCG"). Each of Client and WCG is referred to as a "Party" and collectively as the "Parties." WHEREAS, WCG is the world's largest provider of regulatory and ethical review services for clinical research, and through its Affiliates, provides a range of services including ethical review, compliance, consulting, biosafety, equcation and technology; and WHEREAS, Client requests WCG provide services as are outlined herein. NOW, THEREFORE, the Parties, intending to be legally bound, agree as follows: 1. SERVICES 1.1 The services to be performed and/or products to be provided hereunder ( collectively "Services") shall be set forth in one or more Schedules attached hereto ( each a "Schedule" or a "Services Schedule"), or as added pursuant to Section 1.2. As of the Effective Date, the following Services Schedules are in effect: Schedule A: IRB Services APPLICABLE Schedule B: IBC Services NOT APPLICABLE (c) Schedule C: IRBNet Services NOT APPLICABLE (d) Schedule D: Other Services NOT APPLICABLE 1.2 During the Term, the Parties may add additional Schedules to the Agreement, Any such Schedule shall be executed by the Parties and shall be subject to all the terms of this Agreement and such Schedule. Page 1 of 14 «Contract Number» v

3 1.3 Should the Parties wish to contract for WCG's consulting Services ("Consulting Services"), such Services shall be set forth on one or more statements of work (each a "Statement of Work" or "SOW"), each of which shall be deemed to be incorporated herein. Each SOW shall meet the following criteria: (c) Each SOW shall set forth the scope of Consulting Services to be performed, the Parties' respective responsibilities with respect thereto, the fees associated therewith and any other relevant terms. Each SOW shall be binding upon the Parties upon execution of such SOW by both Parties. Each SOW shall be subject to certain assumptions as shall be set forth therein. In the event that such assumptions are determined to not be true or to have materially changed, then the Parties shall promptly undertake a mutually agreeable change control procedure to determine whether such changes may impact the fees and/or timing associated with such SOW. The Parties shall enter a written change order as necessary and appropriate to account for any such impact. ( d) WCG agrees that any actual deliverables delivered by WCG to Client pursuant to any SOW ("Deliverables") shall be a "work made for hire" and, upon payment in full with regards to such Deliverables, shall be the sole property of Client. WCG shall, at Client's cost and expense, perform all actions reasonably requested by Client to establish and confirm Client's ownership of Deliverables (including, without limitation, assignments and consents). (e) Notwithstanding the foregoing, WCG retains sole and exclusive ownership of all right, title and interest in its work papers, proprietary information, processes, methodologies, know-how and software ("WCG Property"), including such information as existed prior to the delivery of the Services and, to the extent such information is of general application, anything that WCG may discover, create or develop during the provision of Services hereunder. To the extent any Deliverables contain any WCG Property, WCG grants Client a non-exclusive, non-assignable, royaltyfree, perpetual license to use such WCG Property solely in connection with the Deliverables and solely for Client's internal purposes. 1.4 All Services provided hereunder shall be provided by one or more of WCG's Affiliates and its Representatives or Partners. Any such Partners shall be identified in the applicable Schedule or SOW. "Affiliate(s)" shall mean with respect to WCG, any person or entity directly or indirectly controlled by or under common control with WCG Parent, and shall mean with respect to Client, any person or entity directly or indirectly controlling, controlled by, or under common control with Client, and for this purpose, "control," "controlling" and "controlled by" shall mean the ownership and control of more than fifty percent (50%) of the Page 2 of 14 «Contract Number» V

4 outstanding voting securities or interest in capital or profits of any person or entity, or the right to direct or control the management or affairs of any person or entity by contract or similar arrangement. "Partner" means an entity with whom WCG ( or an Affiliate thereof) has a contractual arrangement which permits WCG to resell the Services of such entity. 2. TERM; TERMINATION 2.1 Term. This Agreement shall begin on the Effective Date and continue until the first anniversary thereof, and shall thereafter automatically renew for additional one (1) year periods unless terminated in accordance with the terms hereof, or Party provides notice not to renew more than thirty (30) days before the end of the then-current Term (collectively, the "Term"). Notwithstanding the foregoing, a Schedule or SOW may set forth a specific term with regards to the Services being performed under such Schedule or SOW. 2.2 Termination. Either Party may terminate this Agreement, or any Schedule or SOW hereunder, in each case without cause upon sixty (60) days prior written notice. Either Party may terminate this Agreement in the event of any material breach of this Agreement by the other Party which breach remains uncured for thirty (30) days after written notice thereof by the nonbreaching party. ( c) Either Party may terminate this Agreement if the other Party (i) terminates or suspects its business activities; (ii) becomes insolvent, admits in writing its inability to pay its debts as they mature, makes an assignment for the benefit of creditors, or becomes subject to direct control of a trustee, receiver or similar authority; or (iii) becomes subject to any bankruptcy or insolvency proceeding under federal or state statutes which is not rescinded within sixty (60) days. 2.3 Notwithstanding the termination of this Agreement and expressly as set forth herein, the Term shall be deemed extended with respect to any Schedule or SOW for which Services are still being performed. 3. COMPENSATION 3.1 Fee Schedule. The fees for all Services shall be in accordance with the fee schedule applicable to such Services as are more fully set forth on Exhibit A hereto (the "Fee Schedule"). In addition, Schedules may set forth fees with respect to the Services provided therein, and to the extent included therein, such fees shall be deemed included within the Fee Schedule. Page 3 of 14 «Contract Number» V

5 Expense Reimbursement. Client shall reimburse WCG for all reasonable, documented, out-of-pocket expenses and pass-through costs incurred by WCG in connection with the performance of its obligations hereunder. Invoicing/Payment Terms. Except as expressly set forth herein, WCG shall invoice Client promptly after the applicable expenses are incurred, and/or the applicable Services are rendered. The invoice may be sent by any WCG Affiliate who was involved in the provision of such Services. Except as otherwise expressly set forth, Client shall remit payment for each invoice to WCG within thirty (30) days after receipt of each invoice. 4. INDEMNIFICATION; LIMITATION OF LIABILITY 4.1 Indemnification of WCG. Client agrees to defend, indemnify, and hold harmless WCG and its Affiliates, and their respective directors, officers, employees, agents, and contractors, including its review board committee members (collectively the "WCG Indemnitees"), from and against any and all claims, suits, actions, liabilities, losses, damages, and judgments arising from any third party claim (collectively, "Liabilities") resulting or arising from or caused by in any manner, directly or indirectly, or attributable to, in whole or in part from: For IRB Services, (i) the willful misconduct of Client or any Client Representative; (ii) any clinical or non-clinical Study-related intervention undertaken on any Study; or (iii) the payment or non-payment of any amounts to a human subject made on any Study. 4.2 Limitations. Client will not indemnify WCG for any Liabilities which are solely the result of the willful misconduct of any WCG Indemnitee in connection with the provision of Services by WCG. 4.3 State Law Exemption. Notwithstanding anything in this Section 4 to the contrary, WCG acknowledges that Client is prohibited from agreeing to certain terms and conditions because of restrictions placed upon it by the Laws, Statutes, or Constitution of the State of Virginia ("VA Law"). In the event that VA Law prohibits Client from adhering to a specific term or provision of this Section 4, the following blue pencil provisions shall apply: All other provisions of the Agreement shall remain in full force and effect and shall be strictly construed in order to carry out the intent of the Parties hereto as nearly as may be possible; Nothing herein shall constitute a waiver of the sovereign immunity of the Commonwealth of Virginia or Virginia Tech. Page 4 of 14 «Contract Number» v

6 4.4 Limitation of Liability. NEITHER PARTY SHALL BE ENTITLED TO RECOVER FROM THE OTHER PARTY ANY INCIDENTAL, CONSEQUENTIAL, INDIRECT, SPECIAL OR PUNITIVE DAMAGES (INCLUDING, WITHOUT LIMITATION, DAMAGES FOR LOSS OF BUSINESS, LOSS OF PROFITS OR LOSS OF USE), WHETHER BASED ON CONTRACT, TORT (INCLUDING, WITHOUT LIMITATION, NEGLIGENCE), OR ANY OTHER CAUSE OF ACTION RELATING TO THIS AGREEMENT, EVEN IF SUCH PARTY HAS BEEN INFORMED OR SHOULD HA VE KNOWN OF THE POSSIBILITY OF SUCH DAMAGES. THE TOTAL LIABILITY OF WCG OR ANY AFFILIATE THEREOF IN CONNECTION WITH THIS AGREEMENT, A SCHEDULE, SOW, OR ANY STUDY (WHATEVER THE BASIS FOR THE CAUSE OF ACTION) SHALL NOT EXCEED THE FEES ACTUALLY PAID TO WCG OR ANY AFFILIATE THEREOF FOR THE SPECIFIC SERVICES GIVING RISE TO THE CAUSE OF ACTION WITHIN THE TWELVE (12) MONTHS PRIOR TO THE INCIDENT GIVING RISE TO THE CAUSE OF ACTION. 4.5 Survival. This Section 4 will survive the Term, and shall remain binding upon and for the benefit of the Parties. 5. MISCELLANEOUS. 5.1 Governing Law. The Parties agree that this Agreement shall remain silent with respect to governing law and jurisdiction. 5.2 Notice. All legal notices required hereunder shall be in writing and sent to the address set forth on the signature page, or such other address as is subsequently specified in writing. In addition, a separate notice address may be set forth in any Schedule or SOW, in which case notice address should be used for Services performed thereunder. 5.3 Affiliates. Affiliates of either Party can participate in this Agreement; such Affiliates may be identified in a Schedule, SOW, submission form of the Services being requested/provided, or such other practice as shall be mutually agreed. Each Affiliate that participates under this Agreement shall be severally and solely responsible for its own transactions, liabilities, acts, negligence, conduct and/or responsibilities of any nature arising by reason of such Affiliate's participation under this Agreement. Neither Party, nor any of such Party's participating Affiliates shall be responsible for the transactions, liabilities, acts, negligence, conduct and/or responsibilities of any other participating Affiliate under this Agreement. 5.4 Independent Contractor. WCG, in performance of Services under this Page 5 of 14 «Contract Number» V

7 Agreement, is acting as an independent contractor, not as an employee or agent of Client. 5.5 Insurance. WCG. WCG shall secure and maintain in full force and effect throughout the Term: (i) professional liability insurance in an amount no less than $5,000,000 each claim/$5,000,000 annual aggregate (except for IRBNet, which such professional liability insurance shall be in an amount no less than $1,000,000 each claim/$1,000,000 annual aggregate) and (ii) general liability insurance in an amount no less than $2,000,000 each claim/$4,000,000 annual aggregate. Amounts may be satisfied by umbrella policies. Client. Client is a state university and part1c1pates m a self-insured program for professional liability and general liability exposures. A certificate may be provided upon request. 5.6 No Third Party Beneficiaries. This Agreement shall not confer upon any other person, other than the Parties, any rights or remedies with respect to the subject matter hereof. 5.7 Non Solicitation. During the Term and for one year thereafter, Client shall not solicit or offer work to any of WCG's or its Affiliates' personnel, including without limitation directors, officers, employees, and agents, including all of its review board committee members, but excluding subcontractors ("Representatives"), of whom it comes in contact with in connection with the performance of the services hereunder. 5.8 Conflicting Terms. In the event of a conflict between the terms set forth in the body of this Agreement and either a Schedule, SOW or Exhibit, the terms set forth in the body of such Schedule, SOW or Exhibit shall prevail, unless a provision in the Agreement specifically provides that it overrides any countervailing provision. Furthermore, to the extent that a term is defined differently in more than one Schedule, then for purposes of the Services performed under such Schedule, the defined term shall have the meaning ascribed to such term in such Schedule. This Agreement shall be controlling over additional or different terms of any purchase order or similar document relating to this Services, even if accepted in writing by both Parties. 5.9 Entire Agreement. This Agreement constitutes the entire agreement between the Parties concerning its subject matter and supersedes all other prior oral or written understandings and agreements between the Parties. [remainder of page intentionally left blank] Page 6 of 14 «Contract Number» V

8 DocuSign Envelope ID: E585F18C-99D7-484C-ADFA-A02596FF1684 IN WITNESS WHEREOF, the Parties have executed this Agreement by proper and duly authorized persons. WIRB-COPERNICUS GROUP, INC. ~DocuSlgned by: b;:;.,~~ Name: Title:,.,ch-.i~e..,..f_,O_p_e_r a-t~, -ng---=o...,.ff...,~c-e-r Feb-2018 Date: Address: WIRB - Copernicus Group, Inc. Attn: CFO 212 Carnegie Center, Suite 301 Princeton, NJ With a copy to: Legal Dept th Street, SE, Suite 120 Puyallup, WA VIRGINIA POLYTECHNIC ~DS~L e: W.H~~ Title: Director, Procurement Date: ~;_;L:zoLF: Address: 300 Turner Street NW, Suite 2100, Blacksburg, Virginia Page 7 of 14 «Contract_Number» V

9 EXHIBIT A FEE SCHEDULE(S) 1. IRB Services. IRB Services shall be performed pursuant to WCG's then-current applicable fee schedules (each an "IRB Fee Schedule"), as such IRB Fee Schedules have been provided under separate cover. The IRB Fee Schedule(s) are subject to change in WCG's sole discretion. 2. Intentionally Omitted. 3. Intentionally Omitted. 4. Intentionally Omitted. 5. Intentionally Omitted. Page 8 of 14 «Contract Number» v

10 SCHEDULE A IRB SERVICES 1. IRB Services. The Services performed by WCG under this Schedule are IRB Services. 1.1 Client requests WCG serve as an IRB of record for Studies as specified from time to time. 1.2 WCG agrees to serve as an IRB of record for Client's Studies as specified from time to time, provided that nothing herein will be construed to limit WCG's independence to take actions necessary to protect the subjects' rights and welfare, or to alter WCG's primary duty to the subjects under Applicable Law. 1.3 Scope. (c) WCG is Client's preferred independent IRB. Client shall use WCG as its independent IRB except in those situations where a Sponsor has required the use of another independent IRB, but then only after Client has used good faith efforts to utilize WCG. Client may use WCG as its single institutional review board (sirb) for projects that require those services. For projects requiring sirb services, WCG will provide price quotes on a per project basis. 1.4 Provider of IRB Services. With respect to any Study that is submitted to WCG hereunder, the submission form used shall identify the WCG Affiliate to whom such Study is submitted, unless the Parties mutually agree to another mechanism, and both Parties hereby acknowledge and agree that it is such WCG Affiliate that shall be the IRB of record for Client, and the provider oflrb Services, for such Study. Notwithstanding the foregoing, Client acknowledges that for certain Studies, more than one WCG Affiliate may be involved in the provision of IRB Services, including with regards to WCG's single review service. In such instances the WCG entity that is IRB of record may rely on another WCG Affiliate to perform certain elements of the IRB Services. For example, even if WIRB is the IRB of record for a given Study, CGIRB may perform the initial protocol review or protocol amendment review for a Study, or be responsible for maintaining certain IRB records for a Study. Client expressly permits WCG to rely on its Affiliates in such manner. ( c) Notwithstanding that more than one WCG Affiliate may be involved in the performance of IRB Services, it is understood that for any Site at which a Study is being conducted, only one WCG entity (but not more Page 9 of 14 «Contract Number» v

11 2. WCG Responsibilities. than one, regardless of immediately preceding subsection) will be the IRB of record, and all actions (or inactions) taken in connection with WCG's responsibilities hereunder, and any rights and/or liabilities of WCG in connection with such Site, and the Study being performed at such Site shall inure exclusively to such WCG entity. 2.1 IRB Services. WCG and its Representatives will act as an IRB, performing all tasks and responsibilities required by Applicable Law, including doing the following: Conduct an initial review of each Study. Review all subject information and consent documents. ( c) Review Site-specific materials, including a completed Site-specific submission form. ( d) Provide continuous oversight of each Study it approves. (e) (f) Consistent with 21 C.F.R (±), and as WCG may determine reasonably necessary, Client shall cause each Site to permit site visits by WCG at any time, with reasonable advance notice. A site visit may involve meeting with the Principal Investigator and Site staff, and may include review of the following: the conditions surrounding the conduct of the Study, the Study records, the attitudes of the community from which Study subjects are selected, the current status of the Study, the consent process, subject complaints, unusual reports, unanticipated problems, high drop-out rates, or any other factor that WCG considers relevant to the conduct of Study. Conduct continuing review of each approved Study at intervals appropriate to the degree of risk in such Study, but not less than once per year. 2.2 Notifications. WCG shall send timely notices to the FDA or OHRP as required by Applicable Law, such as (i) any unanticipated problems involving risks to subjects or others; (ii) any serious or continuing noncompliance with FDA or HHS regulations, as applicable, or the requirements or determinations of WCG; and (iii) any suspension or termination of IRB approval. WCG shall promptly notify the Principal Investigator and the applicable institution of any of the following WCG actions relative to a Study: Page 10 of 14 «Contract Number» v

12 (i) (ii) (iii) (iv) Termination or suspension; Serious or continuing noncompliance with the federal regulations or the requirements and determinations of WCG; Approval, disapproval, or recommendation to modify; and Copies of any reports that WCG sends pursuant to Section Knowledge of the Local Research Context. Pursuant to Applicable Law, WCG shall take such actions as are necessary to ensure knowledge of the local research context, including on-site visits, videoconference or teleconference meetings as WCG may deem appropriate, and Client shall provide all such assistance in connection therewith as WCG may reasonably request. 2.4 Debarment. WCG shall not employ any person directly or indirectly to perform any IRB Services if such person is debarred by the FDA under 21 U.S.C. 335a. 2.5 Site Selection Enhancement Services. WCG will provide to Client its site selection enhancement Services whereby WCG works with Sponsors, CROs and other entities in an effort to attract more Studies to Client. To that effect, (i) WCG may seek information about Client to assist in such effort, including with respect to Client's Study history and principal investigators, and (ii) WCG, in its reasonable discretion, may provide such data with such entities. 3. Client Responsibilities. 3.1 Client shall ensure its Principal Investigators are qualified by training and experience as appropriate experts to conduct the Studies. Client will advise the Principal Investigators, CROs, appropriate federal agencies, or other relevant parties, as applicable, that WCG is the IRB of record. 3.2 Client shall promptly communicate or provide, and/or where necessary and applicable, cause each Principal Investigator or Site staff to promptly communicate or provide a completed submission form and any other information required by WCG's standard submission requirements, including the following, to WCG in a timely manner: (c) All the materials required to be provided pursuant to WCG's standard submission process. Any and all amendments to the Study or modifications to the Human Subjects Research. Any documents or information required for WCG to conduct continuing review. Page 11 of 14 «Contract Number» v

13 ( d) Any unanticipated problems that may increase risk to subjects or others including problems that arise during a Study that involve risk to the research subjects or others and are unexpected, involve serious harm or a potential for serious harm to a research subject or other person, and ( c) that are more likely related than unrelated to participation in the Study. 3.3 Other Client Obligations. Nothing in this Agreement will be construed to override or change Client's duties under Applicable Law. In keeping with the requirements of 21 CFR , Client cannot. approve any research study that has been disapproved by WCG. (c) Client agrees to abide by the decisions of WCG and shall use its best efforts to ensure that the research performed by the Client shall be conducted in accordance with those decisions. 4. Fees. 4.1 IRB Services shall be performed pursuant to WCG's then-current applicable fee schedules (each an "IRB Fee Schedule"), which fee schedule(s) are subject to change in WCG's sole discretion. The IRB Fee Schedules in effect as of the date hereof have been provided under separate cover. 4.2 Fees for Consulting Services, if applicable, shall be as set forth in the SOW or Engagement Letter applicable for such Consulting Services. 5. Term; Termination. 5.1 The Term of this Schedule shall be the same as for the Agreement. Notwithstanding the foregoing and at any time, Client may request closure of any Study. 5.2 Notwithstanding the termination or expiration of this Agreement and/or this Schedule, such termination shall not affect WCG's obligations to provide IRB Services for any Study then under review, until such Study is properly closed and/or transferred to and re-reviewed by another responsible IRB, and WCG shall continue to earn fees until such time. 6. Access, Recordkeeping and Reporting. 6.1 Access. It is agreed that Client or its authorized representative(s) may, during regular business hours and upon mutually agreeable terms, arrange with reasonable advance notice to WCG to: Page 12 of 14 «Contract Number» v

14 Inspect WCG's facilities required for performance of the IRB Services to be provided hereunder; and Examine applicable work product relating to the IRB Services to be provided hereunder; provided that before any authorized representative is permitted such access, WCG may require that such representative execute a nondisclosure agreement for the benefit of WCG containing prov1s1ons substantially similar to those set forth in the Agreement. 6.2 Regulatory Audits. WCG agrees to cooperate with governmental authorities in connection with audits and inspections of WCG relative to Client's Studies. 6.3 Records/Retention. WCG shall generate and retain complete written records, documents, accounts, reports and data of the IRB Services performed hereunder in accordance with Applicable Law. 7. Notices. All notices shall be provided in accordance with the provisions set forth in the body of the Agreement. 8. Definitions. Capitalized terms used but not otherwise defined in this Schedule shall have the meanings ascribed to such terms in this Section 8. In addition, to the extent that the body of the Agreement or any other Schedule contains any terms that are defined in this Schedule, and such term is not also defined in the body of the Agreement or such other Schedule, the term shall have the meaning ascribed to it hereto. 8.1 "Applicable Law" means all federal and state laws and regulations governing IRBs and Human Subjects Research, including FDA regulations 21 C.F.R. Parts 50 and 56, and HHS regulations 45 C.F.R. Part 46,. 8.2 "CGIRB" means The Copernicus Group, Inc., an affiliate of WCG. 8.3 "CRO" means a contract research organization, as this term is defined by 21 C.F.R "Principal Investigator" means an individual who actually conducts an investigation, i.e., under whose immediate direction the Test Article, if any, is administered or dispensed to, or used involving, a subject, or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team. 8.5 "Site" means the location(s) where Human Subjects Research-related activities are actually carried out. 8.6 "Sponsor" means the sponsor of any Study. Page 13 of 14 «Contract Number» v

15 8. 7 "Study" means a human subjects research study with which Client is associated and for which WCG is providing Services. 8.8 "WIRB" means Western Institutional Review Board, Inc., an affiliate of WCG. Page 14 of 14 «Contract Number» v