UMC - Page 2 of 255Robyn Caspersen (non-voting member) Donald Mackay Harry Hagerty Jeff Ellis Absent: Michael Saltman - excused Others Present: Stephanie Merrill, Chief Financial Officer

Governing Board

Audit and Finance Committee

January 13, 2016 3:00PM

ProVidence Suite

Trauma Building/5th Floor

800 Rose Street, Las Vegas, NV

• The main agenda is available on University Medical Center of Southern Nevada’s website http://www.umcsn.com. For

copies of agenda items and supporting back-up materials, please contact Terra Lovelin at (702) 765-7949. The Audit & Finance Committee may combine two or more agenda items for consideration.

• Items on the agenda may be taken out of order. • The Audit & Finance Committee may remove an item from the agenda or delay discussion relating to an item at any time.

AGENDA

University Medical Center of Southern Nevada GOVERNING BOARD

AUDIT & FINANCE COMMITTEE January 13, 2016, 3:00 p.m.

800 Rose Street, Las Vegas, Nevada UMC Trauma Building, ProVidence Suite 5th Floor)

Notice is hereby given that a meeting of the UMC Governing Board Audit & Finance Committee has been called and will be held on Wednesday January 13, 2016, commencing at 3:00 p.m. at the UMC Trauma Building, ProVidence Suite (5th Floor), 800 Rose Street, Las Vegas, Nevada to consider the following:

SECTION 1: OPENING CEREMONIES

CALL TO ORDER

1. Public Comment

PUBLIC COMMENT. This is a period devoted to comments by the general public about items on this agenda. If you wish to speak to the Committee about items within its jurisdiction but not appearing on this agenda, you must wait until the “Comments by the General Public” period listed at the end of this agenda. Comments will be limited to three minutes. Please step up to the speaker's podium, clearly state your name and address and please spell your last name for the record. If any member of the Committee wishes to extend the length of a presentation, this will be done by the Chair or the Committee by majority vote.

2. Approval of minutes of the regular meeting of the UMC Governing Board Audit and

Finance Committee meeting of December 9, 2015. (For possible action).

3. Approval of Agenda. (For possible action)

This meeting has been properly noticed and posted in the following locations:

University Medical Center CC Government Center Third Street Building Regional Justice Center 1800 W. Charleston Blvd. 500 S. Grand Central Pkwy. 309 S. Third St. 200 Lewis Ave., 1st Flr. Las Vegas, NV Las Vegas, NV Las Vegas, NV Las Vegas, NV (Principal Office)

City of Las Vegas City of Henderson 400 Stewart Ave. 240 Water St. Las Vegas, NV Henderson, NV

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http://www.umcsn.com/

SECTION 2: BUSINESS ITEMS

4. Review and recommend for approval by the Governing Board the Provider Agreement between Alireza Farabi, M.D., PD and University Medical Center of Southern Nevada for primary care and infectious disease medical services to Ryan White participants; and take action as deemed appropriate. (For possible action)

5. Review and recommend for approval by the Board of County Commissioners also sitting as the Board of Hospital Trustees for University Medical Center of Southern Nevada (UMCSN) the Participation Agreement between HealthTrust Purchasing Group, L.P. and University Medical Center of Southern Nevada; and take action as deemed appropriate. (For possible action)

6. Review and recommend for approval by the Board of County Commissioners also sitting as Board of Hospital Trustees the Lease Agreement for 2040 West Charleston Blvd. between University Medical Center of Southern Nevada (UMCSN) and Daniel L. Orr, D.D.S. M.S. LTD.; and take action as deemed appropriate. (For possible action)

7. Review and recommend for award by the Governing Board RFP No. 2015-04 Prosthetic,

Orthotic and Halo Services to Hanger Prosthetics & Orthotics, Inc. d/b/a Hanger Clinic; and take action as deemed appropriate. (For possible action)

8. Review and recommend for approval by the Governing Board the Agreement for

Intraoperative Neuromonitoring Services with SpecialtyCare; and take action as deemed appropriate. (For possible action)

9. Review and recommend for approval by the Governing Board the Clinical Trial Agreement between ZS Pharma, Dr. David Slattery and University Medical Center of Southern Nevada (UMC) (which includes an MOU between Dr. Slattery and UMC in connection with the services of the Principal Investigator); and take action as deemed appropriate. (For possible action)

10. Review and recommend for approval by the Governing Board the Facility Agreement between Medpace, Inc. and University Medical Center of Southern Nevada (UMC) (which includes a Letter of Indemnification (LOI) between Innocoll and UMC; and take action as deemed appropriate. (For possible action)

11. Review and recommend for approval by the Governing Board the Clinical Trial

Agreement between Janssen Scientific Affairs, LLC, Dr. David Slattery and University Medical Center of Southern Nevada (UMC) (which includes a Memorandum of Understanding between Dr. Slattery and UMC in connection with the services of the Principal Investigator); and take action as deemed appropriate. (For possible action)

12. Review and recommend for approval by the Governing Board the Agreement between

McKesson Technologies, Inc. and University Medical Center of Southern Nevada for Staff Augmentation Services for support of all HL7 Interfaces; and take action as deemed appropriate. (For possible action)

13. Review and recommend for approval by the Board of County Commissioners also sitting as the Board of Hospital Trustees for University Medical Center of Southern Nevada (UMCSN) the Amendment to Group Enrollment Agreement between University Medical Center of Southern Nevada and Health Plan of Nevada, Inc. to provide health care coverage to UMCSN employees, retirees and dependents through a Health Maintenance Organization; and take action as deemed appropriate. (For possible action)

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14. Review and recommend for approval by the Governing Board the Amendment One

between The Rosenberg Group and University Medical Center of Southern Nevada for Project Consultant Services; and take action as deemed appropriate. (For possible action)

15. Review and recommend to the Governing Board the award of the contract for the EHR

system pending negotiation of an acceptable definitive agreement(s); and direct staff accordingly. (For possible action)

16. Receive an update on the 2017 Budget process; and direct staff accordingly. (For

possible action)

17. Receive monthly financial report for November 2015; and direct staff accordingly. (For possible action)

18. Receive an update from the Chief Financial Officer; and direct staff accordingly. (For

possible action) SECTION 3: EMERGING ISSUES

19. Identify emerging issues to be addressed by staff or by the Audit and Finance Committee at future meetings; and direct staff accordingly. (For possible action)

COMMENTS BY THE GENERAL PUBLIC A period devoted to comments by the general public about matters relevant to the Committee’s jurisdiction will be held. No action may be taken on a matter not listed on the posted agenda. Comments will be limited to three minutes. Please step up to the speaker’s podium, clearly state your name and address and please spell your last name for the record.

All comments by speakers should be relevant to the Committee’s action and jurisdiction.

UMC ADMINISTRATION KEEPS THE OFFICIAL RECORD OF ALL PROCEEDINGS OF UMC GOVERNING BOARD AUDIT & FINANCE COMMITTEE. IN ORDER TO MAINTAIN A COMPLETE AND ACCURATE RECORD OF ALL PROCEEDINGS, ANY PHOTOGRAPH, MAP, CHART, OR ANY OTHER DOCUMENT USED IN ANY PRESENTATION TO THE BOARD SHOULD BE SUBMITTED TO UMC ADMINISTRATION. IF MATERIALS ARE TO BE DISTRIBUTED TO THE COMMITTEE, PLEASE PROVIDE SUFFICIENT COPIES FOR DISTRIBUTION TO UMC ADMINISTRATION AND LEGAL COUNSEL.

THE COMMITTEE MEETING ROOM IS ACCESSIBLE TO INDIVIDUALS WITH DISABILITIES. WITH TWENTY-FOUR (24) HOUR ADVANCE REQUEST, A SIGN LANGUAGE INTERPRETER MAY BE MADE AVAILABLE (PHONE: 765-7949).

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University Medical Center of Southern Nevada Governing Board Audit and Finance Committee Meeting December 9, 2015 ______________________________________________________________________________ UMC ProVidence Suite Trauma Building, 5th Floor 800 Rose Street Las Vegas, Clark County, Nevada Tuesday, December 9, 2015 3:00 p.m. The University Medical Center Governing Board Audit and Finance Committee met in the ProVidence Suite, UMC Trauma Building, 5th Floor, Las Vegas, Clark County, Nevada, on Tuesday, December 9, 2015, at the hour of 3:00 p.m. The meeting was called to order at the hour of 3:06 p.m. by Committee Chair Eileen Raney and the following members were present, which constituted a quorum of the members thereof: CALL TO ORDER Board Members:

Present: Eileen Raney, Chair Robyn Caspersen (non-voting member) Donald Mackay Harry Hagerty Jeff Ellis

Absent: Michael Saltman - excused

Others Present: Stephanie Merrill, Chief Financial Officer Susan Pitz, General Counsel Terra Lovelin, Board Secretary

SECTION 1. OPENING CEREMONIES ITEM NO. 1 PUBLIC COMMENT

Chair Raney asked if there were any persons present in the audience wishing to be heard on any item on this agenda.

Speaker(s): None

ITEM NO. 2 Approval of minutes of the regular meeting of the UMC Governing Board

Audit and Finance Committee meeting on November 10, 2015. (For possible action)

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Governing Board Audit & Finance Committee December 9, 2015 Page 2 of 7

ACTION TAKEN: A motion was made by member Mackay that the minutes be approved as recommended. Motion carried by unanimous vote.

ITEM NO. 3 Approval of Agenda (For possible action)

ACTION TAKEN: A motion was made by member Hagerty that the agenda be approved as recommended. Motion carried by unanimous vote.

SECTION 2. BUSINESS ITEMS ITEM NO. 4 Review and recommend for approval by the Governing Board the

Application of a Sub-Grant Award (HD # 15130) for the Ryan White HIV/AIDS Part B Program between the State of Nevada Department of Health and Human Services Health Division and University Medical Center of Southern Nevada and authorize the CEO to accept the Sub-Grant if and when awarded; and take action as deemed appropriate. (For possible action)

DOCUMENTS SUBMITTED:

-Notice of Sub-Grant Award

DISCUSSION: John Liston, Director of Materials Management explained that the application was for a Sub-Grant award for the State of Nevada and would allow for the funding of the additional mental health and substance abuse counseling. Member Ellis asked Jan Richardson, Wellness Center Manager, a question with regards to the funding. Jan replied that the amount of the grant is more than we may be able to spend in the three months time. ACTION TAKEN: A motion was made by member Hagerty to approve and make a recommendation to the Governing Board to approve the Agreement. Motion carried by unanimous vote.

ITEM NO. 5 Review and recommend for approval by the Governing Board, new

“Professional Services Agreements (Individual and Group Physician On-Call Coverage)” for Neurosurgery/Spine, Adult Urology and Cardiac Anesthesia Services, and authorize the CEO to execute Individual or Group Agreements with providers of these on-call services, and to approve each agreement extension year if/when each option is exercised; and take action as deemed appropriate. (For possible action)

DOCUMENTS SUBMITTED: - Professional Services Agreement (Individual Physician On-Call Coverage) - Professional Services Agreement (Group Physician On-Call Coverage)

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DISCUSSION: Member Hagerty asked why Adult Urology is “TBD” and General Counsel Susan Pitz explained that the fair market valuation for Urology has not been finalized as of today. This item will be pulled off the Consent Agenda for the Governing Board if they can’t get it by tomorrow.

ACTION TAKEN: A motion was made by member Ellis to approve and make a recommendation to the Governing Board to approve the Agreement. Motion carried by unanimous vote.

ITEM NO. 6 Review and recommend for approval by the Governing Board, a Notice of

Option to Extend the Interlocal Agreement for Family Medicine Resident and Fellow Moonlighting at UMC, with the Board of Regents of the Nevada System of Higher Education on behalf of the University of Nevada School of Medicine; and take action as deemed appropriate. (For possible action)

DOCUMENTS SUBMITTED: - Letter of Notice

DISCUSSION: A discussion ensued about the hourly rate of pay for the physicians at the clinic. It was noted that the pay is slightly lower than what we pay our Per Diems but we are within fair market value.

ACTION TAKEN: A motion was made by member Hagerty to approve and make a recommendation to the Governing Board to approve the Agreement. Motion carried by unanimous vote.

ITEM NO. 7 Review and recommend for approval by the Governing Board, Amendment

Two to Agreement for Physician Professional Services for Urgent Care Services, with the University of Nevada School of Medicine Integrated Clinical Services, Inc. and University of Nevada School of Medicine Multispecialty Group Practice South, Inc. d/b/a/ Medschool Associates South, Inc., to extend the Agreement for 12 months; and take action as deemed appropriate. (For possible action)

DOCUMENTS SUBMITTED: - Amendment Two to Agreement

DISCUSSION: Mr. Liston noted that this agreement is with the faculty side and for Urgent Care.

ACTION TAKEN: A motion was made by member Mackay to approve and make a recommendation to the Governing Board to approve the Agreement. Motion carried by unanimous vote.

ITEM NO. 8 Review and recommend for ratification by the Governing Board Amendment Two to Quality Measures Abstraction Agreement between

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Primaris Holdings, Inc. and University Medical Center of Southern Nevada; and take action as deemed appropriate. (For possible action)

DOCUMENTS SUBMITTED: - Agreement

DISCUSSION: This amendment is to request Sepsis one chart abstractions. This is a CMS mandated reporting with all the discharges. The annual cost to add this is $12,600.

ACTION TAKEN: A motion was made by member Mackay to approve and make a recommendation to the Governing Board to approve the Agreement. Motion carried by unanimous vote.

ITEM NO. 9 Review and recommend for approval by the Governing Board the Provider

and Hospital Agreements between Aetna Health, Inc. and University Medical Center of Southern Nevada (UMC); and take action as deemed appropriate. (For possible action)

DOCUMENTS SUBMITTED: - Draft Agreement

DISCUSSION: Rose Coker, Director of Managed Care explained that Aetna purchased Coventry Health Care, and First Health and they are merging the contracts together so they had to rewrite the language. Ms. Coker and Ms. Pitz are working on finalizing certain legal language in the contract and anticipate receiving it back from Aetna’s Legal team tomorrow. The negotiated rates will remain the same.

ACTION TAKEN: A motion was made by member Hagerty to approve and make a recommendation to the Governing Board to approve the Agreement. Motion carried by unanimous vote.

ITEM NO. 10 Review and recommend the ratification of the Third Amendment to the

Hospital Participation Agreement between Choice Care Network and University Medical Center of Southern Nevada; and take action as deemed appropriate. (For possible action)

DOCUMENTS SUBMITTED: - Third Amendment Agreement

DISCUSSION: Ms. Coker explained that we are extending the terms of this contract and this meets our requirements. Member Ellis asked how many years it was being extended for and Mr. Coker replied that it was for two years, then a rate increase will occur after the two years.

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ACTION TAKEN: A motion was made by member Mackay to approve the Agreement and make a recommendation to the Governing Board to approve the Agreement. Motion carried by unanimous vote.

ITEM NO. 11 Review and recommend for approval by the Governing Board the Agreement

between Radiometer America, Inc. and University Medical Center of Southern Nevada for Blood Gas Analyzers, Software, Supplies and Associated Support; and take action as deemed appropriate. (For possible action)

DOCUMENTS SUBMITTED: - Quote from Radiometer America Inc.

DISCUSSION: Mr. Liston explained that this agreement is for equipment lease and supplies; the term of the agreement is for five years. Member Caspersen asked about the price and Mr. Liston replied that this vendor is on our GPO and was the best price, it was actually $4,000.00 cheaper per year.

ACTION TAKEN: A motion was made by member Ellis to approve the Agreement and make a recommendation to the Governing Board to approve the Agreement. Motion carried by unanimous vote.

ITEM NO. 12 Receive monthly update on the Electronic Health Record (EHR) System

Replacement and direct staff accordingly. (For possible action)

DOCUMENTS SUBMITTED: -EHR Update Audit and Finance Committee

DISCUSSION: Brian Rosenberg, consultant gave a brief update on where we are at with the EHR system. He explained that demonstrations have occurred, surveys were completed and staffing needs are being reviewed. Ernie McKinley, Chief Information Officer, explained that the intent is to fill the positions needed for this, from within the hospital. For this to work, the best people from each department need to be involved. The time frame for involvement in the project would be two years.

Member Hagerty asked if we will bring in a Contract Specialist with a background in these types of agreements to look at the contract. Mr. McKinley said that there were people available to do this and he can definitely get someone on board if needed. Susan Pitz, General Counsel agreed that someone with a background in EHR contracts would be helpful in the review process and suggesting engaging someone as soon as possible.

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ACTION TAKEN: None Taken

ITEM NO. 13 Receive monthly financial report for October 2015; and direct staff

accordingly. (For possible action)

DOCUMENTS SUBMITTED: -October FY 2016 Financials

DISCUSSION: Chief Financial Officer, Stephanie Merrill gave a review of the financials for October FY 2016. Member Hagerty asked if we had any comparative metrics as to what like-sized institutions spend in capital expenditure as a percentage of some operating metric. He would like to see how we compare to other institutions. Chair Raney said we could get that information from University Health Consortium. Chair Raney also brought up robotics and CFO Merrill said that they are back on track for December. It was suggested that Dr. Don Galloway, Director of Surgical Services come to the February meeting and present surgery stats.


ITEM NO. 14 Receive an update from the Chief Financial Officer; and direct staff

accordingly. (For possible action)

DOCUMENTS SUBMITTED: -None

DISCUSSION: Ms. Merrill noted that Ms. Pitz and she attended the iContracts training; it is up and ready to go.


SECTION 3: EMERGING ISSUES ITEM NO. 15. Identify emerging issues to be addressed by staff or by the Audit and

Finance Committee at future meetings; and direct staff accordingly. (For possible action)

Chair Raney suggested the committee meet to discuss the EHR proposal. Mr. Rosenberg said he will be ready to present the EHR recommendation and budget to Audit and Finance in January.

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A discussion ensued as to availability of the members for a special meeting if needed.

COMMENTS BY THE GENERAL PUBLIC:

At this time, Chair Raney asked if there were any persons present in the audience wishing to be heard on any items not listed on the posted agenda.

SPEAKERS(S): None There being no further business to come before the Committee at this time, at the hour of 4:34 p.m., Chair Raney adjourned the meeting. MINUTES APPROVED: MINUTES TAKEN BY: Terra Lovelin

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Execution Copy for UMCSN

PARTICIPATION AGREEMENT

Participant Name: University Medical Center (UMC) of Southern Nevada

Effective Date: April 1, 2016

Version: 2015-06-10

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TABLE OF CONTENTS

1. Definitions. .......................................................................................................................... 1

2. Purchase of Products and Services; Facilities. .................................................................... 3

3. Term and Custom Agreements. ........................................................................................... 4

4. Covenants and Responsibilities of HealthTrust. .................................................................. 5

5. Covenants and Responsibilities of Participant. ................................................................... 6

6. HealthTrust Disclaimer, Company Release and Indemnification ....................................... 8

7. GPO Fees, Rebates, and Global Sourcing Fees. .................................................................. 8

8. Termination. ....................................................................................................................... 10

9. Confidentiality. .................................................................................................................. 11

10. Limitation of Liability. ...................................................................................................... 13

11. Access to Books and Records. ........................................................................................... 13

12. Audit Rights. ...................................................................................................................... 14

13. Notices. .............................................................................................................................. 14

14. Assignment. ....................................................................................................................... 14

15. Entire Agreement. .............................................................................................................. 15

16. Severability. ....................................................................................................................... 15

17. Governing Law; Consent to Jurisdiction. .......................................................................... 15

18. Waiver of Jury Trial. .......................................................................................................... 15

19. Counterparts; Means of Execution. ................................................................................... 16

20. Amendment. ....................................................................................................................... 16

21. Data. ................................................................................................................................... 16

22. No Third-Party Beneficiaries. ............................................................................................ 17

23. Drug Enforcement Administration Registration Numbers. ............................................... 17

24. Name and Logos. ............................................................................................................... 17

25. Force Majeure. ................................................................................................................... 17

Exhibits

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PARTICIPATION AGREEMENT This Participation Agreement is between HealthTrust Purchasing Group, L.P. (“HealthTrust”), a Delaware limited partnership and the following entity (“Participant”) (together with all Exhibits, this “Agreement”). Participant Legal Name: University Medical Center (UMC) of Southern Nevada d/b/a: Address: 1800 W. Charleston Blvd. City, State, Zip: Las Vegas, NV 89102 State of Organization: Nevada Signer’s Name and Title: Mason VanHouweling, CEO Signer’s Phone Number: 702-383-2000 Signer’s Email: [email protected]

WHEREAS, HealthTrust is a “group purchasing organization” that is structured to comply with the requirements of the “safe harbor” regulations regarding payments to group purchasing organizations set forth in 42 C.F.R. §1001.952(j) and that maintains agreements with vendors for purchasing products, dietary products, equipment and services used by hospitals and other healthcare facilities as part of a group purchasing program; and WHEREAS, Participant desires to participate in such group purchasing program, and to purchase products and services under such agreements in accordance with the terms and conditions thereof. In consideration of the premises as well as the agreements and covenants detailed in this Agreement, and for other good and valuable consideration, the receipt and adequacy of which is hereby acknowledged, the Parties hereby agree as follows: 1. Definitions.

As used herein, the following terms have the following meanings:

1.1 “Affiliate” means, with respect to a specified person or entity, any person or entity that directly or indirectly controls, is controlled by or is under common control with the specified person or entity. A person or entity shall be deemed to control another person or entity if such first person or entity has the power, directly or indirectly, to direct or cause the direction of the management and policies of such other person or entity, whether through ownership of voting securities, by contract or otherwise.

1.2 “Agreement” means this Participation Agreement, as amended from time to time.

1.3 “BAA” means a Business Associate Agreement entered into between HealthTrust and a

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mailto:[email protected]


Vendor to address possible disclosure of Protected Health Information under HIPAA by a Facility to a Vendor.

1.4 “Compliance Level” has the meaning set forth in Section 5.2 hereof.

1.5 “Effective Date” means the date indicated in the title page of this Agreement.

1.6 “Eligibility Date” means the date Participant and Facilities will be able to start purchasing products and services under the Program.

1.7 “Facility” or “Facilities” means Participant, the Participant hospitals, other Participant healthcare facilities, and other Affiliates of Participant listed on Exhibit B hereto, which will participate in the Program.

1.8 “GPO Affiliation Certificate” means a certificate in the form set forth as Exhibit C hereto.

1.9 “GPO Fees” has the meaning set forth in Section 7 hereof.

1.10 “HCA” means HCA Holdings, Inc., a Delaware corporation, and any successor thereto.

1.11 “HealthTrust Website” means the portion of HealthTrust’s website (www.healthtrustpg.com) that is restricted to access by participants in HealthTrust.

1.12 “HealthTrust Vendor Lists” has the meaning set for in Section 4.1 hereof.

1.13 “HIPAA” means the Administrative Simplification Provisions of the Health Insurance Portability and Accountability Act of 1996, as codified at 42 U.S.C. §1320d.

1.14 “PHI” means Protected Health Information or individually identifiable health information.

1.15 “Party or Parties” means HealthTrust and Participant individually as Party or collectively as Parties.

1.16 “Products and Services” means the products, dietary products, pharmaceuticals, equipment and services, including distribution services, available pursuant to HealthTrust Vendor Contracts.

1.17 “Program” means the group purchasing program conducted by HealthTrust, pursuant to which Participant, its Facilities and other healthcare facilities are provided access to HealthTrust Vendor Contracts to purchase Products and Services.

1.18 “Term” means the time period this Agreement shall be in effect as described in Section 3, including any extensions thereof.

1.19 “Vendor(s)” or “HealthTrust Vendor(s)” means the supplier(s) of Products and Services under HealthTrust Vendor Contracts.

1.20 “Vendor Contracts” or “HealthTrust Vendor Contracts” means the purchasing agreements between Vendors and HealthTrust for the purchase of Products and



Services, as well as any other agreements related thereto, such as, but not limited to, BAAs, which are listed on the HealthTrust Website, as updated from time to time by HealthTrust.

2. Purchase of Products and Services; Facilities.

2.1 Eligibility Date. On the Eligibility Date, Participant and Facilities will be eligible to purchase Products and Services under the Program. HealthTrust shall provide notice to Participant of the Eligibility Date.

2.2 Intent of Parties. It is the intent of the Parties to establish a business relationship that complies with the Medicare and kickback statute set forth in 42 U.S.C. §1320a-7b(b). The parties agree that, for the purposes of this Agreement, HealthTrust is acting as a group purchasing organization. The Parties intend to comply with the requirements of the “safe harbor” regulations regarding payments to group purchasing organizations set forth in 42 C.F.R. §1001.952(j) and the Parties believe that this Agreement satisfies those requirements.

2.3 Exclusivity. Subject to the terms and conditions set forth in this Agreement and except for Participant’s membership in Cardinal Health 188 LLC, doing business as VitalSource, for the purchase of oncology, rheumatology and other specialty pharmaceutical products, or as otherwise set forth herein, Participant hereby designates HealthTrust to act as the exclusive independent group purchasing organization for Participant and all Facilities. During the Term of this Agreement, neither Participant nor any of its Facilities shall utilize, participate in or maintain membership in any other group purchasing organization, or utilize any group purchasing, consulting, analytics or contracting services in any other group purchasing organization except for any of Participant’s existing agreements, which Participant will allow to expire or exercise any appropriate termination clauses. Notwithstanding the foregoing, and with the exception of Cardinal Health 188 LLC, doing business as VitalSource, and to those third party agreements described in Exhibit A, attached hereto, none of which shall constitute a membership in another group purchasing organization, the parties intend that this Agreement shall be the exclusive arrangement that Participant and its Facilities utilize for the purchase through a group purchasing organization or similar entity. Participant represents and warrants that its entering into this Agreement does not constitute a default or breach by Participant of any agreement to which Participant is a party; this warranty and representation shall remain in effect throughout the Term.

2.4 Authorization. Participant, on behalf of itself and its Facilities, hereby authorizes HealthTrust, as agent to: (i) negotiate the terms of and enter into HealthTrust Vendor Contracts, and to cancel or modify any HealthTrust Vendor Contracts as it deems necessary, advisable or appropriate; (ii) receive rebates from HealthTrust Vendors based on purchases under HealthTrust Vendor Contracts by Participants and Facilities, for payment by HealthTrust to Participant pursuant to Section 7.2; and (iii) receive from HealthTrust Vendors, distributors, and e-commerce companies, data relating to purchases of Products and Services under HealthTrust Vendor Contracts, as well as for products and services not purchased through HealthTrust Vendor Contracts, by Participant and Facilities.

2.5 No Separate Agreements. Participant and its Facilities shall not (itself or through third



parties) negotiate amendments or modifications to HealthTrust Vendor Contracts or separate agreements with HealthTrust Vendors for Products and Services without the prior written approval of HealthTrust.

2.6 GPO Affiliation Certificate. Each Facility shall execute and deliver to HealthTrust the GPO Affiliation Certificate (a copy of which is attached as Exhibit C) prior to being granted access to the Program.

2.7 Facilities Acquired by Participant. If Participant or any of its Affiliates acquires any new hospital or other healthcare facility, or enters into an agreement to manage the supply chain function of an independent healthcare provider, Participant shall advise HealthTrust in writing of such event within thirty (30) days following closing of the transaction. Unless otherwise mutually agreed, HealthTrust and Participant shall enter into an amendment adding such entity as a Facility effective not later than one hundred eighty (180) days following the date of such closing; or in the event such entity is subject to a membership agreement with another GPO signed prior to the closing date, not later than thirty (30) days following the expiration of the then existing term of the GPO membership agreement for such entity. Entities must qualify as Affiliates of Participant to qualify as a Facility and Participant must be able to meet its obligations under Section 5.6 as to any entity listed as a Facility on Exhibit B.

2.8 Facilities Divested by Participant. Any Facilities divested by Participant or its parent Affiliate, or which no longer qualify as an Affiliate of Participant, shall be removed from participation under this Agreement at the conclusion of the transition period described as follows. In this event, Participant shall provide HealthTrust with written notice thereof at least thirty (30) days prior to the closing date of such divestiture or date of ceasing to be an Affiliate of Participant (“Divestiture Date”). Such divested Facility shall have the right to continue to participate under this Agreement for a ninety (90) day transition period following the Divestiture Date, or until the divested Facility commences participation with a competitor GPO, whichever first occurs. During such transition period, the divested Facility shall participate under this Agreement as an independent member of HealthTrust separate from Participant and the non-divested Facilities. All payments for rebates earned by the divested Facility during such transition period and any reports or other communications shall be provided by HealthTrust directly to the divested Facility.

2.9 Purchase of Products and Services. The Facilities identified on Exhibit B hereto shall have access to the Program and may purchase Products and Services under HealthTrust Vendor Contracts. Each Facility that makes a purchase shall be subject to all terms and conditions of this Agreement applicable to Participant and/or Facilities.

3. Term and Custom Agreements.

3.1 Term. Subject to termination under Section 8 hereof, the term of this Agreement shall be for a period of five (5) years commencing on the Effective Date (“Initial Term”) with the option to extend for terms of five (5) years each (“Renewal Term”) upon written mutual consent. HealthTrust and Participant shall each have the right to terminate this Agreement without cause at any time two (2) years after the Effective Date by providing one hundred eighty (180) days written notice to the other Party.



3.2 Custom Agreements. In the event this Agreement expires or is terminated without being replaced by a new participation agreement, any separate agreement or commitment entered into by Participant or any of its Facilities under any Vendor Contract (“Custom Agreement”) shall terminate concurrently with this Agreement unless such Custom Agreement (i) expressly provides that it survives termination of this Agreement, or (ii) has a stated term related to the purchase or lease of capital equipment and does not have any automatic termination provision in the event Participant and/or Facilities no longer participate in the Program.

3.3 Survival. To ensure regulatory compliance and to permit Participant and its Facilities to meet their contractual commitments to HealthTrust Vendors: (i) if a Vendor permits Participant to actually purchase Products and Services under any HealthTrust Vendor Contracts after the designated termination or expiration date for this Agreement; or (ii) Participant or any Facility has an obligation to purchase Products or Services under its own commitment under a HealthTrust Vendor Contract or Custom Agreement, then Participant remains a member of the Program and this Agreement remains in effect on a non-exclusive basis for such limited purposes and for so long as such purchases continue.

4. Covenants and Responsibilities of HealthTrust.

4.1 Access to the Program. HealthTrust shall provide Participant with access to the HealthTrust Website. HealthTrust maintains a current list of HealthTrust Vendor Contracts on the HealthTrust Website which are hereby incorporated as part of this Agreement (“HealthTrust Vendor Lists”). The HealthTrust Website also provides access to Products and Services, pricing, delivery, ordering requirements and other terms thereof, available for purchase under Vendor Contracts, which can be accessed in the secure section of HealthTrust’s Website under the tab titled “Contracts”. HealthTrust shall notify Participant of new Vendor Contracts and shall periodically update the HealthTrust Website to provide a current list of HealthTrust Vendor Contracts. The parties to this Agreement hereby agree that, upon posting an updated list of HealthTrust Vendor Contracts on the HealthTrust Website, this Agreement shall be deemed amended to incorporate such updated list of HealthTrust Vendor Contracts. Participant and its Facilities agree: (i) to periodically (at least annually) check such website to obtain a copy of this updated list of HealthTrust Vendor Contracts; and (ii) to comply with all terms and conditions of access and use of the HealthTrust Website, as provided on such HealthTrust Website.

4.2 Notification to Vendors. HealthTrust shall notify HealthTrust Vendors that Participant and its Facilities are eligible to purchase under HealthTrust Vendor Contracts.

4.3 HealthTrust Conferences. HealthTrust may host conferences in which educational presentations are provided for members and HealthTrust Vendors participate in a vendor event in which their products and services are featured to member attendees. In such event, a limited number of Participant representatives may be permitted to attend such conferences with HealthTrust underwriting a portion of the costs thereof. The number of Participant representatives invited and the costs covered shall be at the discretion of HealthTrust, but will generally be comparable to that provided other members of HealthTrust of similar size as Participant.



4.4 Services by HealthTrust Affiliates. Participant acknowledges that HealthTrust and partners in HealthTrust have Affiliates that provide healthcare services and other kinds of services related to the provision of healthcare. Certain of these Affiliates may, from time to time, make proposals to, or do business with, Participant or its Affiliates. Participant and its Affiliates shall not be required to accept any such proposal, or to do any such business, as a result of this Agreement or any other business relationship between HealthTrust and Participant and their respective Affiliates. It is understood by the parties that execution of this Agreement does not give rise to any obligation whatsoever, either express or implied, on the part of Participant or any of its Affiliates to provide any business or referrals to HealthTrust, any partner in HealthTrust, or any Affiliates of HealthTrust or any Affiliates of such partner.

5. Covenants and Responsibilities of Participant.

Participant, for itself and for each of the Facilities that purchase under HealthTrust Vendor Contracts, whether or not set forth on Exhibit B hereto, hereby represents and warrants to, and covenants with, HealthTrust as follows:

5.1 Compliance with Contract Terms. Participant agrees to cause each of the Facilities to: (i) comply with all terms of this Agreement as if a party hereto; (ii) comply with all terms of HealthTrust Vendor Contracts, including without limitation, payment terms and compliance levels; and (iii) execute separate agreements or acknowledgements as reasonably requested by HealthTrust or any particular HealthTrust Vendor evidencing such Facility’s participation in the Program and agreement to comply with the terms of this Agreement and the relevant Vendor Contracts.

5.2 Meeting the Compliance Level. Subject to any exceptions expressly stated in this Agreement, for: (i) the twelve-month period commencing on the Eligibility Date; and (ii) each twelve-month period commencing on the first day of each calendar quarter during the term of this Agreement, Participant and its Facilities in the aggregate shall meet or exceed the Compliance Level, which is defined as: of all product purchased by Participant and Facilities which are the same or comparable to Product available under HealthTrust Vendor Contracts with a sole, dual or multi-source award status, at least eighty percent (80%) of such purchases (as measured in dollars spent by Participant) were made under HealthTrust Vendor Contracts. Notwithstanding the foregoing, purchases of products or services other than under HealthTrust Vendor Contracts, when necessary for patient care considerations that are not able to be met by Products and Services, shall not be included in the calculation for meeting the Compliance Level.

5.3 Compliance Certificate. At the request of HealthTrust, within sixty (60) days after the last day of any calendar quarter, Participant shall deliver to HealthTrust a certificate to the effect that Participant and its Facilities are in compliance with Section 5.2 hereof in respect of the twelve-month period ending on the last day of such calendar quarter. Such certificate shall set forth the information described on Exhibit D hereto and such additional information as HealthTrust shall reasonably request.

5.4 Existing Vendor Contracts. In the event that Participant’s existing contracts as of the Effective Date and set forth on Exhibit A hereto do not permit Participant to comply with Section 2.3 or Section 5.2 hereof with respect to one or more Facilities and any one or more particular HealthTrust Vendor Contracts, Participant shall transition such



Facility or Facilities to the particular HealthTrust Vendor Contracts in the Program at the first appropriate opportunity. Nothing in this Section 5.4 shall be construed to require or encourage Participant or any of its Facilities to improperly terminate or breach in any way any existing Vendor Contract to which Participant or any of its Facilities is a party. The parties acknowledge and agree that Exhibit A may be amended from time to time as Participant locates existing supplier contracts so long as the same were executed prior to the Effective Date of this Agreement.

5.5 Purchases Are For Own Use. Participant agrees that all products purchased by it or its Facilities under HealthTrust Vendor Contracts will be for use in the provision of healthcare services in its Facilities, and not for resale or distribution to third parties other than in the course of the provision of healthcare services by such Facilities. Participant acknowledges that such prohibition on resale and distribution extends to resale or distribution to physician practices other than those owned, controlled, or managed by Participant and listed on Exhibit B. The parties acknowledge that to the extent any Vendor Contracts contain prohibition of purchases by physician practices, any Participant Facilities listed on Exhibit B as physician practices shall not be able to purchase under those contracts until so advised by HealthTrust.

5.6 Affiliates of Participant. Participant warrants that all Facilities listed on Exhibit B as of the Effective Date and as later added to Exhibit B by amendment, qualify as Affiliates of Participant and furnish services to third parties for which payment may be made in whole or in part under Medicare or a state healthcare program.

5.7 Warranty of Non-Exclusion. Participant hereby represents and warrants that it and its Facilities are not currently excluded, debarred, or otherwise ineligible to participate in Federal healthcare programs as defined in 42 USC § 1320a-7b(f) or any state healthcare program (the “Healthcare Programs”) and to Participant’s knowledge, are not under investigation or otherwise aware of any circumstances which may result in Participant or any Facility being excluded from participation in the Healthcare Programs. These representations and warranties shall be ongoing during the Term, and Participant shall immediately notify HealthTrust of any change in the status of the representations and warranties set forth in this Section 5.7.

5.8 Business Associate Agreements. Participant acknowledges and agrees that HealthTrust may provide on the HealthTrust Website, copies of BAAs as a convenience for all HealthTrust participants. HealthTrust does not accept any legal, financial or other obligation or responsibility relating to the BAAs or the posting of BAAs. Participant further acknowledges and agrees that it is solely responsible for determining if the BAAs meet its own legal and other obligations under HIPAA and any other laws and regulations. Participant further acknowledges that there may be certain Vendors which have not entered into a BAA with HealthTrust. HealthTrust does not accept any legal, financial, or other obligation relating to Participant’s reliance on the absence of a BAA between a Vendor and HealthTrust as suggesting that a BAA is not required, and Participant is solely responsible for determining: (i) whether a BAA with a Vendor is required; and (ii) the content of any such BAA.

5.9 HealthTrust is Not a Business Associate. It is not the intent of this relationship to have PHI disclosed by Participant or any Facility to HealthTrust or to, in any way, make HealthTrust a Business Associate to Participant or any Facility.



6. HealthTrust Disclaimer, Company Release and Indemnification

6.1 Disclaimer. All purchases under HealthTrust Vendor Contracts by Participant and its Facilities for Products and Services shall be between Participant or such Facility as applicable and the Vendor. HealthTrust shall not be a party to any such purchases and shall have no liability under any such agreement or with respect to any such purchases or any Products and Services furnished under any such agreement. WITHOUT LIMITING THE GENERALITY OF THE FOREGOING: (i) HEALTHTRUST DOES NOT MAKE, AND EXPRESSLY DISCLAIMS, ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR ANY OTHER WARRANTY, EXPRESS OR IMPLIED, AS TO ANY PRODUCTS AND SERVICES SOLD BY ANY HEALTHTRUST VENDOR; AND (ii) PARTICIPANT HEREBY EXPRESSLY RELEASES HEALTHTRUST FROM ANY AND ALL LIABILITY AND CLAIMS RELATING TO THE HEALTHTRUST PRODUCTS AND SERVICES, AND ANY BREACH OR ALLEGED BREACH OF WARRANTY IN CONNECTION WITH THE HEALTHTRUST PRODUCTS AND SERVICES.

6.2 Participant/Facility Indemnity. To the extent expressly authorized by Nevada law, Participant and its Facilities shall defend, indemnify and hold harmless HealthTrust, the partners in HealthTrust, and their respective Affiliates, agents, officers, directors and employees (the “Indemnitees”) from and against any and all losses, liabilities, damages, costs and expenses (including reasonable attorneys’ fees, witness fees, investigation expenses, any and all other out-of-pocket expenses, any punitive or consequential damages, and any other expenses incident thereto), in connection with third party claims or actions relating to acts or omissions of Participant and Facilities which relate in any way to this Agreement or purchases from Vendors, including without limitation, any claims resulting from a failure to pay for any Products and Services purchased by Participant or any of its Facilities, any product liability claims associated with the Products and Services purchased by Participant or any of its Facilities, or any failure to comply with Participant’s obligations to allocate Rebates under Section 7.2 herein.

7. GPO Fees, Rebates, and Global Sourcing Fees.

7.1 GPO Fees. Participant acknowledges that: (i) HealthTrust will receive payment of fees for administrative and other services provided by HealthTrust from Vendors based on Products and Services purchased, licensed or leased by Participant and its Facilities (“GPO Fees”) during the Term of this Agreement; (ii) the percentage of the GPO Fees will generally be three percent (3%) or less from each Vendor if a GPO Fee is paid, but may in some cases be higher; and (iii) HealthTrust will receive GPO Fees from some Vendors that are distributors of Products in amounts that are one percent (1%) or less but resulting in an aggregate GPO Fee from both HealthTrust Vendor manufacturer and HealthTrust Vendor distributor that may exceed three percent (3%) of the purchase price paid by a Facility, but which shall not exceed four percent (4%) of the purchase price paid by a Facility. With respect to HealthTrust Vendor Contract between AT&T and HealthTrust for long distance telephone services, HealthTrust receives a GPO Fee of four and one half percent (4.5%). The HealthTrust Website includes: (a) lists of HealthTrust Vendor Contracts; (b) lists of HealthTrust Vendor Contracts where HealthTrust Vendors have agreed to pay GPO Fees of three percent (3%) or less; (c) lists of HealthTrust Vendor Contracts with distributors listing the GPO Fee to be paid to



HealthTrust by each distributor; and (d) lists of HealthTrust Vendor Contracts where HealthTrust Vendors have agreed to pay GPO Fees to HealthTrust greater than three percent (3%), including the specific percentage of the GPO Fee or the maximum GPO Fee. HealthTrust shall disclose to Participant on an annual basis, in writing, with respect to purchases of Products and Services by each Participant and by each of the Facilities, the names of HealthTrust Vendors and the specific amount of GPO Fees received from each of such Vendors for Products and Services purchased by Participant and its Facilities. HealthTrust shall disclose to the Secretary of the United States Department of Health and Human Services, upon request, the amount of GPO Fees received by HealthTrust from each Vendor with respect to Products and Services which are purchased, licensed or leased by Participant and its Facilities. Participant agrees to disclose the applicable GPO Fee information provided by HealthTrust regarding such GPO Fees to each of its Facilities. All GPO Fees received by HealthTrust as a result of purchases by Participant and its Facilities under the survival provisions of Section 3.3 shall be retained by HealthTrust.

7.2 Rebates. HealthTrust agrees to pay to Participant any funds received from Vendors designated as Vendor rebates based on purchases of Products and Services by Participant and its Facilities during the term of this Agreement. Participant acknowledges that any such rebates received from HealthTrust in respect to purchases made under HealthTrust Vendor Contracts will be allocated among all Facilities participating in the Program in amounts proportionate to the dollar amount of Products and Services giving rise to such rebate purchased by each Facility participating in the Program and as otherwise required by law and/or regulation. The amount of any rebate distributed to Participant shall be treated as a discount to Participant’s and Facilities’ cost for the applicable Products and Services. The Participant is responsible for allocating any such rebate so received, as well as any rebate received directly from any Vendor, among its Facilities and for providing all required information regarding such rebate amounts and allocations to its Facilities as required by law and/or regulation. It is the intent of the parties hereto to establish a business relationship, which complies with the Medicare, and Medicaid anti-kickback statutes set forth at 42 U.S.C. §1320a-7b(b). In certain instances, invoices from Vendors may not accurately reflect the net cost of Products and Services to the Participant and/or Facility. Where a discount or other reduction in price is applicable, the parties also intend to comply with the requirements of 42 U.S.C. §1320a-7b(b)(3)(A) and the “safe harbor” regulations regarding discounts or other reductions in price set forth in 42 C.F.R. §1001.952(h). In this regard, the parties hereto acknowledge that Participant will satisfy, and ensure that its Facilities satisfy any and all legal and regulatory requirements imposed on buyers. Thus, Participant will accurately report, under any state or federal program that provides cost or charge based reimbursement for the Products and Services covered by this Agreement, the net cost actually paid by the Participant and/or Facility, pursuant to such Vendor Contracts.

7.3 Global Products and Global Sourcing Fee. Participant acknowledges that HealthTrust is engaged in a program to achieve savings on products (“Global Products”) by sourcing them internationally through a coordinated arrangement with a third party (or third parties). Due to the investment of HealthTrust in this program, as well as the services and clinical expertise that HealthTrust will dedicate to sourcing products globally, pricing for Global Products made available to Participants and Facilities for purchase



may also include a fee payable to HealthTrust (a “Global Sourcing Fee”). While the Global Sourcing Fee is not calculated based on a specific formula related to sourcing costs, the amount of the Global Sourcing Fee will range from zero percent (0%) up to a maximum of five percent (5%) of the sourcing costs. As used in this Section, “sourcing costs” includes costs for purchasing Global Products from the manufacturer and transportation and logistics costs for delivery to the distribution warehouse.

8. Termination.

8.1 HealthTrust’s Right to Terminate for Non-Compliance or Breach.

8.1.1 Termination for Non-Compliance or Breach. HealthTrust shall have the right to terminate this Agreement on ninety (90) days’ prior notice to Participant if: (i) Participant and its Facilities, taken as a whole, fail to maintain the Compliance Level for any two consecutive calendar quarters; (ii) Participant or any of its Facilities fails to comply with the terms and conditions of any of HealthTrust Vendor Contracts; or (iii) Participant or any of its Facilities otherwise breaches any material provision of this Agreement, provided, however, that HealthTrust may so terminate this Agreement in the event of a breach described above only if HealthTrust shall have given Participant written notice of the specifics of the breach and Participant shall not have cured such breach or caused such breach to be cured within ninety (90) days thereafter. Notwithstanding the foregoing, in the event Participant is in breach of the exclusive group purchasing provisions in Sections 2.3 of this Agreement, HealthTrust may terminate this Agreement immediately if such breach has not been cured within fifteen (15) days following notice of such breach. The foregoing termination rights shall be in addition to the rights and remedies provided in Section 9.5 or elsewhere in this Agreement, or at law or equity. HealthTrust’s termination rights under this Agreement shall not be construed to alter, modify or limit in any way HealthTrust’s or any Indemnitee’s rights and remedies as an Indemnitee under this Agreement.

8.1.2 Termination for Transfer of Ownership or Bankruptcy of Participant. HealthTrust shall also have the right to terminate this Agreement in its entirety upon ninety (90) days’ prior notice: (i) upon the transfer, directly or indirectly, by sale, merger or otherwise, of substantially all of the assets of Participant or its ultimate parent or any permitted assignee to an independent third party (upon assignment to such assignee); (ii) in the event that more than forty-nine percent (49%) of Participant’s capital stock or equity ownership, or the capital stock or equity ownership of its ultimate parent, or any such permitted assignee is transferred to an independent third party entity; (iii) upon Participant filing for protection under any bankruptcy laws or being the subject of any involuntary bankruptcy proceeding; or (iv) upon Participant and all Facilities failing to make any purchases under any HealthTrust Vendor Contracts over any sixty (60) day period. If Participant ceases to do business as a going concern at the address(es) listed on Exhibit B to this Agreement or any subsequent new address for which notice has been provided to HealthTrust, HealthTrust shall have the right to terminate this Agreement effective fifteen (15) days after sending notice of termination to Participant.

8.1.3 Termination for Transfer of Ownership or Bankruptcy of a Facility. HealthTrust



shall also have the right to terminate this Agreement with respect to any particular Facility, upon ninety (90) days’ prior notice to Participant and the Facility: (i) upon the transfer, directly or indirectly, by sale, merger or otherwise, of substantially all of the assets of the Facility to an independent third party; (ii) in the event that more than forty-nine percent (49%) of the Facility’s capital stock or equity ownership is transferred to an independent third party entity; (iii) upon Facility filing for protection under any bankruptcy laws or being the subject of any involuntary bankruptcy proceeding; (iv) upon Facility failing to make any purchases under any HealthTrust Vendor Contracts over any sixty (60) day period; or (v) if Facility is managed by Participant, upon termination of Participant’s agreement with Facility to manage its material management function. HealthTrust shall also have the right to terminate this Agreement with respect to any Facility with fifteen (15) days’ prior notice upon the Facility becoming a member of another Group Purchasing Organization. If a Facility ceases to do business as a going concern at the address(es) listed on Exhibit B to this Agreement, HealthTrust shall have the right to terminate this Agreement with respect to such Facility effective fifteen (15) days after sending notice of termination to Participant and the Facility.

8.2 Participant’s Right to Terminate; Sole Remedy. Except as provided in Section 9.6, Participant, as its sole remedy, may terminate this Agreement if HealthTrust (including HealthTrust employees, agents, officers, partners or subcontractors) breaches any material provision in this Agreement and fails to cure such breach within ninety (90) days from receipt of written notice thereof.

8.3 No Continuing Obligations. Upon termination of this Agreement, HealthTrust shall have no further obligations hereunder, including, without limitation, no obligation to maintain, update or advise Participant or its Facilities concerning any Products or Services provided hereunder, except (i) as necessary to support any continuing contracts under Section 3.3, (ii) except to pay to Participant its allocable portion of any rebates earned prior to termination, and (iii) to provide the applicable reporting for rebates and GPO Fees with respect to Participant purchases from Vendors made prior to termination or for any Custom Agreements that remain in effect after the date of intended termination. HealthTrust shall have no obligation to pay Participant any amounts received by HealthTrust from Vendors more than one (1) year after termination of this Agreement based on purchases by Participant or Facilities under Vendor Contracts. Participant shall remain obligated to pay for all purchases by it and the Facilities made under such Vendor Contracts.

9. Confidentiality.

9.1 Confidential Information. ”Confidential Information” is defined to include the terms and exhibits of this Agreement all information, documents and instruments (including, without limitation, all information regarding the pricing, rebates, discounts, shipping terms and other terms and conditions of HealthTrust Vendor Contracts) delivered or otherwise provided to Participant or its Facilities, or any of their agents, directors, officers or employees as well as information relating to quantities of Products and Services purchased by Participant and/or its Facilities, except as otherwise expressly provided in this Agreement.



9.2 Confidentiality Requirements; Authorization to use Confidential Information. Participant agrees that throughout the term of this Agreement and for a period of five (5) years thereafter it and Facilities shall maintain all Confidential Information in strict confidence, shall use such Confidential Information only as is required in connection with its provision of healthcare services, and may disclose such Confidential Information only on a “need to know” basis to its duly authorized officers, directors, representatives, consultants, accountants, attorneys and agents and to the duly authorized officers, directors, representatives and agents of its Affiliates, subject to the confidentiality provisions contained in this Agreement and any Vendor Contract. Participant shall communicate to each recipient the confidentiality obligations of this Agreement, and shall cause those persons to hold Confidential Information in strict confidence as if a party hereto. Prior to receipt of any Confidential Information, Participant shall submit the above described non-employees of Participant or any Facility (e.g., consultants) (“Other Persons”) to HealthTrust for approval, not to be unreasonably withheld, and for signing, a written confidentiality agreement prepared by HealthTrust. Notwithstanding anything herein to the contrary, the definition of “Other Persons” shall not include any entity that functions as a group purchasing organization or is an Affiliate of such an entity, such disclosures being expressly prohibited unless approved in advance in writing by HealthTrust. HealthTrust agrees to maintain in confidence the quantities of Products and Services purchased by Participant and its Facilities and any other information on written documents disclosed to HealthTrust by Participant and labeled as “Confidential” (“Participant Confidential Information”) and to not disclose such Participant Confidential Information to any third parties, except that HealthTrust may use and disclose Participant Confidential Information as permitted in Section 21, Data.

9.3 Exceptions. Notwithstanding the foregoing, no party hereto shall be prohibited from using or permitting the use of and no party shall be required to hold in confidence any information to the extent that: (i) such information has been or is in the public domain, or publically known, through no fault of such party; or (ii) such information is lawfully acquired by such party from sources other than a party hereto, any Facility or Affiliate of such party, or any of their respective agents, directors, officers or employees, and the acquisition of such information is without restriction of further disclosure and, to the knowledge of the acquiring party, is not in breach of any confidentiality obligation to which the party providing such information is subject.

9.4 Government Facilities. Notwithstanding Section 9.2 above, in the event that any Facility is a governmental unit and is required by law to disclose certain confidential information to the public, Participant shall not be liable pursuant to Section 9.2 above, provided, that such Facility: (i) furnishes only that portion of the information which such Facility is required by law to disclose; (ii) furnishes such information only in a manner to the extent that is required to comply with applicable laws and regulations; (iii) informs HealthTrust of the required disclosure and the legal basis on which such disclosure is required to be made prior to making such disclosure; and (iv) affords HealthTrust the opportunity to intervene for the purpose of seeking an appropriate protective order or otherwise protecting HealthTrust’s interest in the information to be disclosed.

9.5 Compelled Disclosures. To the extent that a party hereto, any Affiliate of a party, any Facility or, to the knowledge of such party, any current or former employee of any such



party or entity is requested (by oral questions, interrogatories, requests for information or documents, subpoena, civil investigative demand or similar process) to disclose any information required to be kept confidential pursuant to Section 9.2 above, such party agrees to take all necessary action to maintain, or cause to be maintained (and to cause any such Affiliate or Facility, or in respect of a current or former employee, to use its reasonable efforts to cause such employee to maintain) the confidentiality of such information and to provide prompt notice to the other party, so that such other party may seek an appropriate protective order or waive compliance with Section 9.2 above. If, in the absence of a protective order or the receipt of a waiver hereunder, the person who has received such a request is, nonetheless, in the reasonable written opinion of counsel, legally required to disclose such information, such person may disclose such information, and no party shall be liable pursuant to Section 9.2 above, provided, that such person: (i) furnishes only that portion of the information which it is advised by counsel to disclose; and (ii) exercises its reasonable efforts to obtain assurance that confidential treatment will be accorded to the disclosed portion of the information. Notwithstanding the foregoing, each party shall be permitted to disclose confidential information in any proceeding in which it is in an adversarial position to the other party.

9.6 Remedies for Breach of Confidentiality. In the event HealthTrust, Participant or any of its Facilities breaches any confidentiality obligation provided herein, the non-breaching entity shall be entitled to specific performance and injunctive relief, without any showing of irreparable harm or damage, and any requirement for the securing or posting of any bond, or submitting proof of the economic value of, any trade secret in connection with such remedy is hereby waived. Such remedies shall not be deemed to be the exclusive remedies for any breach by HealthTrust, Participant or any of its Facilities of any confidentiality obligation herein, and will be in addition to all other remedies available at law or in equity.

10. Limitation of Liability.

Except for indemnification and confidentiality obligations provided herein, in no event will Participant, Facilities, HealthTrust or any of their respective Affiliates, agents, officers, directors and employees be liable to each other for any indirect, punitive, special, incidental or consequential damage each may suffer in connection with or arising out of this Agreement (including loss of profits, use, data or other economic advantage), however it arises, whether for breach of this Agreement, or in tort, even if they have been previously advised of the possibility of such damage.

11. Access to Books and Records.

Until the expiration of four (4) years after the term of this Agreement (including any renewal term), HealthTrust shall make available to the Secretary of the United States Department of Health and Human Services, the United States Comptroller General, and their duly authorized representatives, in accordance with 42 C.F.R. § 420.300 et seq., this Agreement and all books, documents, and records necessary to certify the nature and extent of the costs of the services provided by HealthTrust hereunder. If HealthTrust carries out any of its duties hereunder through a subcontract worth $10,000 or more over a twelve-month period with a related organization, the subcontract also shall contain an access clause to permit such access by the Secretary, the Comptroller General, and their duly authorized representatives to the related organization’s books, documents and records. The parties agree that any attorney-client,



accountant-client or any other legal privilege shall not be deemed waived by virtue of the provisions of this Section 10.

12. Audit Rights.

HealthTrust shall have the right, at its expense, to review and audit the books, records, and documents (whether in hardcopy, electronic or other form) of Participant and the Facilities to verify compliance with their obligations under this Agreement, the volumes of purchases of Products and Services under Vendor Contracts, and to obtain any data and information required for HealthTrust to fulfill its responsibilities as a group purchasing organization for healthcare providers. The audit shall be conducted only after reasonable notice and during normal business hours, and may be conducted by HealthTrust’s employees or agents, or by a third party auditor. This right of audit may be exercised no more than one (1) time per year for Participant and each Facility. Participant agrees to cooperate with HealthTrust to provide the above-stated materials, and to provide any reasonable assistance to HealthTrust and its auditors necessary for HealthTrust to carry out any audit as permitted herein, at no cost to HealthTrust.

13. Notices.

All notices or other communications required or permitted under this Agreement shall be in writing and sent by express delivery service, with proof of delivery, electronic mail with receipt acknowledgement or delivered personally. Notices shall be deemed to have been given upon receipt. Notices shall be addressed to each Party as set forth below:

Address for Notice:

Vice-President, Sales and Marketing HealthTrust Purchasing Group, L.P.

155 Franklin Road, Suite 400 Brentwood, Tennessee 37027 Email: [email protected]

Fax No. (615) 344-3164 With a copy to: Chief Legal Officer HealthTrust Purchasing Group, L.P. 155 Franklin Road, Suite 400 Brentwood, Tennessee 37027 Email: [email protected] Fax No. (855-347-7805) Participant: to the address provided in the text box.

14. Assignment.

Neither Participant nor any Facility may assign this Agreement, or any of its rights or obligations set forth herein, without the prior written consent of HealthTrust. No assignment in violation of the provisions of this Agreement shall vest any rights in any purported assignee. Participant hereby consents to assignment by HealthTrust of its rights and obligations under



this Agreement to any Affiliate of HCA Holdings, Inc., or to a successor entity of HealthTrust as part of an internal reorganization of HealthTrust which results in HealthTrust being organized in one or more different legal entities or any other corporate form(s), whether through conversion, merger, or otherwise. Subject to the foregoing, all terms, conditions, covenants and agreements contained herein shall inure to the benefit of and be binding upon any successor and any permitted assignees of the respective parties hereto. It is further understood and agreed that consent by HealthTrust to the assignment of this Agreement by Participant or any Facility in one instance shall not constitute consent by HealthTrust to any other assignment.

15. Entire Agreement.

15.1 Entire Agreement. This Agreement, together with the exhibits thereto, as such exhibits may be modified or supplemented from time to time pursuant to the terms of this Agreement, sets forth the entire agreement and understanding of the parties hereto in respect of the transactions contemplated hereby, and supersedes all prior agreements, arrangements and understandings relating to the subject matter hereof. No party hereto has relied upon any oral or written statement, representation, warranty, covenant, condition, understanding or agreement made by any other party or any representative, agent or employee thereof, except for those expressly set forth in this Agreement or in the exhibits hereto.

15.2 All rights and remedies conferred under this Agreement or by any other instrument or law shall be cumulative and may be exercised singularly or concurrently. The failure by either Party to enforce any term shall not be deemed to be a waiver of future enforcement of that or any other term of this Agreement.

16. Severability.

This Agreement shall be construed to be in accordance with any and all applicable federal and state laws and regulations. In the event there is a change in any applicable laws and regulation that has any material effect on the legality of any provision of this Agreement (“Affected Provision”), then the Affected Provision shall be deemed ineffective to the extent of such change in law or regulation without invalidating the remaining provisions hereof or affecting the validity or enforceability of such Affected Provision in any other jurisdiction., subject to renegotiation in good faith by the parties at the written request of either Party (the Party making such request is hereinafter referred to as the “Requesting Party”). If the parties are unable to renegotiate the Affected Provision to bring it into compliance with the applicable law or regulation within forty-five (45) days of the date on which the Requesting Party provides notice of the change, the Affected Provision will be terminated and be of no further force and effect. In such event, the remainder of the Agreement shall remain in full force and effect.

17. Governing Law; Consent to Jurisdiction.

This Agreement shall be governed by and construed in accordance with the laws of the State of Nevada without regard to the conflict of laws and principles.

18. Waiver of Jury Trial.

PARTICIPANT AND HEALTHTRUST EACH HEREBY ACKNOWLEDGES AND



AGREES THAT ANY CONTROVERSY WHICH MAY ARISE UNDER THIS AGREEMENT IS LIKELY TO INVOLVE COMPLICATED AND DIFFICULT ISSUES; THEREFORE, EACH PARTY IRREVOCABLY AND UNCONDITIONALLY WAIVES ANY RIGHT IT MAY HAVE TO A TRIAL BY JURY WITH RESPECT OF ANY LEGAL PROCEEDING DIRECTLY OR INDIRECTLY ARISING OUT OF, OR RELATING TO, THIS AGREEMENT, OR THE TRANSACTIONS CONTEMPLATED BY THIS AGREEMENT. EACH PARTY REPRESENTS AND CERTIFIES THAT NO REPRESENTATIVE, AGENT OR ATTORNEY OF ANY OTHER PARTY HAS REPRESENTED THAT SUCH OTHER PARTY WOULD NOT SEEK TO ENFORCE THE FOREGOING WAIVER IN THE EVENT OF LITIGATION. EACH PARTY UNDERSTANDS AND HAS CONSIDERED THE IMPLICATIONS OF THIS WAIVER. EACH PARTY MAKES THIS WAIVER VOLUNTARILY. EACH PARTY REPRESENT THAT IT HAS BEEN INDUCED TO ENTER INTO THIS AGREEMENT BY, AMONG OTHER THINGS, THE MUTUAL WAIVERS AND CERTIFICATIONS IN THIS SECTON 18.

19. Counterparts; Means of Execution.

This Agreement and any amendments may be executed by the Parties hereto individually or in any combination, in one or more counterparts, each of which shall be an original and all of which shall together constitute one and the same agreement. Execution and delivery of this Agreement and any amendments by the Parties shall be legally valid and effective through: (i) executing and delivering the paper copy of the document; (ii) transmitting the executed paper copy of the document by facsimile transmission, or electronic mail in “portable document format” (“.pdf”) or other electronically scanned format; or (iii) creating, generating, sending, receiving or storing by electronic means this Agreement and any amendments, the execution of which is accomplished through use of an electronic process associated with this Agreement, and executed or adopted by a Party with the intent to execute this Agreement (i.e., “electronic signature” through a process such as DocuSign®).

20. Amendment.

Except as provided in Section 4.1, this Agreement may be amended, modified, superseded or supplemented only by a written instrument expressly stating an intent to amend, modify, supersede, or supplement this Agreement, executed and delivered by each of the parties.

21. Data.

HealthTrust shall be the exclusive owner of the compilation of pricing data related to Products and Services. All purchasing transaction data (other than pricing data related to Products and Services) resulting from purchase of Products and Services by Participant and Facilities shall be owned by Participant. Participant agrees to transmit its procurement data to HealthTrust through a data feed in a format and frequency specified by HealthTrust. Participant hereby authorizes HealthTrust to have access to Participant’s (and Facilities’) purchasing transaction data, whether through Vendors, distributors, or any business-to-business e-commerce companies through which orders for Products and Services, as well as for products and services not purchased through HealthTrust Vendor Contracts, are placed by Participant and its Facilities. Participant further authorizes HealthTrust to use purchasing transaction data from Participant and Facilities for statistical analysis, GPO functions and other similar purposes, to provide such data to other members and third parties provided such data is de-identified and no



portion of the data contains any patient identification information or information that can be specifically traced to Participant, in which case such purchasing transaction data shall not be Confidential Information.

22. No Third-Party Beneficiaries.

This Agreement is solely for the benefit of the parties hereto, and should not be construed to confer upon any other person any remedy, claim, liability, right of reimbursement, claim of action or other right.

23. Drug Enforcement Administration Registration Numbers.

Participant hereby consents to HealthTrust providing Drug Enforcement Administration registration numbers (“DEA” numbers) for itself and all Facilities, to HealthTrust Vendors, including authorized HealthTrust distributors; and to HealthTrust receiving such DEA numbers from HealthTrust Vendors, authorized HealthTrust distributors, and any other appropriate sources.

24. Name and Logos.

Participant authorizes HealthTrust to use Participant’s names and logos, as provided by Participant to HealthTrust, on HealthTrust’s proprietary website and other HealthTrust publications listing Participant among other entities that are members of HealthTrust.

25. Force Majeure.

Neither Party shall be liable to the other Party for any delay or failure to perform its obligations hereunder if such delay or failure results from causes beyond its reasonable control. Such causes may include, without limitation, acts of God, fires or other catastrophes, telecommunications failures, equipment failures, power failures, labor disputes, strikes, delays in transportation, riots, war, governmental regulations, non-performance by suppliers and Vendors, or problems experienced by HealthTrust as a result of its own, HCA Holdings, Inc. or any other third party’s computer software or hardware failures (an “Event of Force Majeure”). Each Party shall give the other Party prompt notice of any Event of Force Majeure that may cause delay or non-performance of its obligations hereunder.

26. Authority and Public Records Act

The Parties acknowledge that this Agreement has to be reviewed and approved by the appropriate Governing Board of Participant at a duly noticed public meeting which complies with the requirements of Nevada’s Open Meeting Law. The Parties also acknowledge that Participant is subject to Chapter 239 of Nevada Revised Statute more commonly known as the Nevada Public Records Act.

[Signature page follows]



IN WITNESS WHEREOF, each party hereto has duly executed, or has caused this Agreement to be duly executed, as of the date first above written. HealthTrust Purchasing Group, L.P. By its general partner, HPG Enterprises, LLC HealthTrust Signee: HealthTrust Signee Name: HealthTrust Signee Title: HealthTrust Signature Date:

University Medical Center (UMC) of Southern Nevada Participant Signee: Participant Signee Name: Participant Signee Title: Participant Signature Date:



Exhibits List

The following Exhibits are part of the Agreement and are hereby incorporated by reference.

A. Compliance Exceptions Required by Limitations Imposed Under Participant’s Existing Vendor Contracts

B. List of Participant Hospitals and Other Healthcare Facilities and Services C. GPO Affiliation Certificate D. Compliance Certificate

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EXHIBIT A

Compliance Exceptions Required by Limitations Imposed by Participant’s Existing Supplier Contracts

[Describe contract parties, products and services covered by long term contracts, and provide termination date.]

To Be Mutually Determined by between parties after execution of Agreement, whereas existing supplier contracts may be added so long as the effective date of said supplier contract is not after

the execution date of this Agreement. January April 1, 2016

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Exhibit B

LIST OF HOSPITALS AND OTHER HEALTHCARE FACILITIES AND SERVICES

Facility Name University Medical Center (UMC) of Southern Nevada Address: 1800 W. Charleston Blvd. City, ST, Zip: Las Vegas, NV 89102 Relationship to Participant: Owned Managed Joint Venture Partnership Other Class of Trade: Acute Care Description (Facility Type): Public Health Facility

Page B-1 Page 47 of 255


EXHIBIT C GPO Affiliation Certificate

The Participant listed at the end of this GPO Affiliation Certificate (“GPOAC”) and those Facilities on the attached

list (if any is attached) hereby confirm that they have designated HealthTrust Purchasing Group, L.P. (“HealthTrust”) as their sole GPO affiliation pursuant to a written Participation Agreement with University Medical Center (UMC) of Southern Nevada dated as of __________________. Participant and those Facilities listed on the attached shall be eligible to participate in the Program upon HealthTrust providing notice to Vendor and Participant of Participant’s “Eligibility Date”. Eligibility Date shall mean the date Participant and Facilities will be able to start purchasing products and services under the Program. Vendors having contracts with HealthTrust are hereby instructed and authorized to remove the Participant and Facilities from any other GPO affiliations for purchasing products from such Vendors. HealthTrust is hereby authorized to provide copies of this GPOAC to its Vendors and HealthTrust Vendors shall be entitled to rely on the contents of this GPOAC. The parties agree that changes to Participant’s and any Facility’s DEA number, contact information, address correction and other such information that do not change the terms and conditions of the Participation Agreement may be completed in the HealthTrust databases without requiring any amendment to the Participation Agreement. Participant, on behalf of each Facility on the attached list also confirms that an authorized representative of the Facility has received a copy of the referenced Participation Agreement. All terms used but not otherwise defined herein have the meanings stated in the Participation Agreement. This GPOAC confirms agreement by each Facility that, in consideration of being granted access to the Program and HealthTrust Vendor Contracts available under the Program, the Facility will comply with, and be bound by, all of the terms and conditions of the Participation Agreement as if a party thereto. This GPOAC further confirms agreement that, with regard to purchases made by any Participant/Facility under HealthTrust Vendor Contracts, each will purchase products from Vendor only for its “own use” in the provision of healthcare services. Each Participant/Facility will comply with all terms and conditions of such Vendor Contracts, including without limitation payment terms, compliance levels, and arbitration or other dispute resolution provisions. Participant and each Facility recognize that failure to comply with these obligations could result in termination of the Participation Agreement. This GPOAC, the Participation Agreement and any amendments to such documents (each, a “Document”), may be executed by the Parties hereto individually or in any combination, in one or more counterparts, each of which shall be an original and all of which shall together constitute one and the same agreement. Execution and delivery of this Agreement and any amendments by the Parties shall be legally valid and effective through (i) executing and delivering the paper copy of the document, (ii) transmitting the executed paper copy of the document by facsimile transmission, or electronic mail in “portable document format” (“.pdf”) or other electronically scanned format, or (iii) creating, generating, sending, receiving or storing by electronic means this Agreement and any amendments, the execution of which is accomplished through use of an electronic process associated with this Agreement, and executed or adopted by a Party with the intent to execute this Agreement (i.e., “electronic signature” through a process such as DocuSign®). Participant, on behalf of itself and each Facility, acknowledges that with respect to its purchases from Vendors, (a) HealthTrust is acting as a group purchasing organization for which it will receive fees from Vendors and (b) Participant and Facilities may receive rebates from Vendors either directly or through HealthTrust. With respect to such rebates, Participant and Facilities intend to comply with the requirements of the applicable law and safe harbor regulations. University Medical Center (UMC) of Southern Nevada *GPOID:

Participant Signee:

Page C-1 *GPOID will be entered by HealthTrust for all locations.

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A list containing the name of the Facilities with specific identification information is attached hereto and incorporated herein.

Participant Signee Name:

Participant Signee Title:

Participant Signature Date:

Page C-2 *GPOID will be entered by HealthTrust for all locations.

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GPO Affiliation Certificate Facility List

Non-Pharmacy Eligibility Date: January 1, 2016 Pharmacy Eligibility Date: January 1, 2016 Facility Name University Medical Center (UMC) of Southern Nevada Address: 1800 W. Charleston Blvd. City, ST, Zip: Las Vegas, NV 89102 Relationship to Participant: Owned Managed Joint Venture Partnership Other Class of Trade: Acute Care Description (Facility Type): Public Health Facility *GPOID:

Page C-2 *GPOID will be entered by HealthTrust for all locations

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EXHIBIT D

Compliance Certificate At HealthTrust’s request, the compliance certificate described in Section 5.3 of the Agreement shall include, at least, the following information for each Facility:

1. Participant at a minimum must provide to HealthTrust, on a quarterly (calendar) basis, the total non-distributed supply expense and total non-distributed enterprise-wide expense.

2. Where possible, Participant must additionally supply on a quarterly basis to HealthTrust total

non-distributed contract spend by contract number.

3. Participant agrees to cause its distributor to provide to HealthTrust, on a quarterly basis, total distributed and contracted supply expense (net of distributor mark-up) by contract number and to additionally provide total distributed (contract and non-contract) supply expense by Facility.

Page D-1

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LEASE AGREEMENT

THIS LEASE is entered into by and between the BOARD OF HOSPITAL TRUSTEES on behalf of UNIVERSITY MEDICAL CENTER OF SOUTHERN NEVADA (hereinafter referred to as "LESSOR") and DANIEL. ORR, D.D.S., M.S., LTD. (hereinafter referred to as "LESSEE").

WITNESSETH:

WHEREAS, LESSOR is the owner of that certain real property and six story office

BUILDING located at 2040 West Charleston Boulevard, Las Vegas, Nevada, known as the "2040 Medical Education BUILDING" (hereinafter referred to as "2040 BUILDING").

WHEREAS, Nevada Revised Statute 450.440(4)(d) provides that LESSOR may rent office

space to members of University Medical Center of Southern Nevada's (UMCSN) medical staff in facilities owned or operated by LESSOR in order to attract and/or retain current staff physicians; and

WHEREAS, LESSOR desires to lease its space in the 2040 BUILDING for use as medical

offices to members of its medical staff; and

WHEREAS, LESSEE is a member of LESSOR's medical staff; and

WHEREAS, LESSEE desires to lease office space in the 2040 BUILDING from LESSOR to be used as a medical office.

NOW THEREFORE, in consideration of the rents, covenants and agreements contained

herein, Lessor leases to Lessee, and Lessee leases from Lessor certain professional medical office space comprised of a portion of the 2040 BUILDING containing approximately 1,733 square feet, commonly referred to as Suite 201, in the building located at 2040 W. Charleston Blvd, Las Vegas, Nevada.

1. TERM: The term of this lease shall become effective on the 1st day of February,

2016, and subject to Paragraphs 2.4 and 2.5, below, shall remain in effect through Midnight on the 31st day of January, 2019.

2. BASE RENT: The Base Rent reserved for the premises leased to the LESSEE

hereunder shall be the sum of Three Thousand Thirty-Two and 75/100 Dollars ($3,032.75) per month, (as adjusted pursuant to paragraph 2.1 hereunder) which sum represents One and 75/100 Dollars ($1.75) per square foot, to be paid to LESSOR in lawful money of the United States of America, which LESSEE agrees to pay monthly in advance, without deduction, claim, offset, prior notice or demand at such place or places as may be designated from time to time by LESSOR.

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2.1. Adjusted Base Rent: As of each Lease Anniversary Date, the Base Rent payable during the ensuing twelve-month period shall be increased by an amount equal to four percent (4%) of the rate for the prior period or by an amount equal to the change in the Consumer Price Index, All Urban Consumers, United States City Average for the most recent consecutive twelve month period, whichever is less. The Index in publication three (3) months before the Lease Anniversary Date shall be the "Comparison Index." When the Base Rent payable as of each Lease Anniversary Date is determined, LESSOR shall promptly give LESSEE thirty (30) days' written notice of such adjusted Base Rent and the manner in which it was computed. The Base Rent as so adjusted from time to time shall be the "Base Rent" for purposes under this Lease.

2.2. Definition of Rent: All costs and expenses which Lessee assumes or agrees to

pay to LESSOR under this Lease shall be deemed additional rent (which, together with the Base Rent is sometimes referred to as the "Rent"). The Rent shall be paid to LESSOR's Accounts Receivable Department.

2.3. Definition of Termination Date: The termination date shall be ninety (90)

days after LESSOR has served LESSEE with a notice to quit the premises.

2.4 Fiscal Fund-Out: This Agreement shall terminate and LESSOR'S obligations under it shall be extinguished at the end of any of LESSOR'S fiscal years in which LESSOR'S governing body fails to appropriate monies for the ensuing fiscal year sufficient to fund LESSOR'S obligations under this Agreement.

2.5 Budget Act: In accordance with NRS 354.626, the financial obligations of

LESSOR under this Lease shall not exceed those monies appropriated and approved by LESSOR for operation and maintenance of the 2040 BUILDING during the then current fiscal year under the Local Government Budget Act.

3. INTEREST: If LESSEE fails to pay within ten (10) days of when Rent is due, any

Rent or other amounts or charges which LESSEE is obligated to pay under the terms of this Lease, the unpaid amounts shall bear interest at the prime commercial rate then being charged by Bank of America, Nevada, plus two percent (2%) per annum. LESSEE acknowledges that the late payment of any Monthly Installment of Base Rent will cause LESSOR to lose the use of that money and incur costs and expenses not contemplated under this Lease, including without limitation, administrative and collection costs, attorney's fees, and processing and accounting expenses, the exact amount of which is extremely difficult to ascertain. Acceptance of any interest charge shall not constitute a waiver of LESSEE's default with respect to a non-payment by LESSEE or prevent LESSOR from exercising any other rights or remedies available to LESSOR under this Lease.

4. SECURITY DEPOSIT: In consideration of LESSEE'S full and faithful performance of

the terms and conditions of its existing lease with LESSOR for the subject premises which has been in effect since November 1, 1987, LESSOR agrees to waive the security deposit.

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5. LESSEE'S USE OF THE PREMISES: LESSEE shall not use or occupy the Premises in violation of law or any covenant, condition or restriction affecting the 2040 BUILDING, of which LESSEE has been given a copy prior to execution of this Lease, or the certificate of occupancy issued for the BUILDING, and shall, upon notice from LESSOR, immediately discontinue any use of the Premises which is declared by any governmental authority having jurisdiction to be a violation of law or certificate of occupancy. LESSEE, at LESSEE's own cost and expense, shall comply with all laws, ordinances, covenants, restrictions, regulations, rules and/or any directions of any governmental agencies or authorities having jurisdiction which shall, by reason of the nature of LESSEE's use or occupancy of the Premises impose any duty upon LESSEE or LESSOR with respect to the Premises or its use or occupation. A Judgment of any court of competent jurisdiction or the admission by LESSEE in any action or proceeding against LESSEE that LESSEE has violated any such laws, ordinances, covenants, restrictions, regulations, rules and/or directions in the use of the Premises shall be deemed to be a conclusive determination of that fact as between LESSOR and LESSEE. Conversely, a Judgment of any Court of competent jurisdiction, or the admission by any opposing party in any action or proceeding against LESSEE that LESSEE has not violated any such laws, ordinances, regulations, rules and/or directions in the use of the Premises shall be deemed to be a conclusive determination of that fact as between LESSOR and LESSEE. LESSEE shall not knowingly do or permit to be done anything which will invalidate or increase the cost of any fire, extended coverage or other insurance policy covering the 2040 BUILDING and/or property located therein, and shall comply with all rules, orders, regulations, requirements and recommendations of the LESSOR'S Insurance Carrier or any other organization performing a similar function. LESSEE shall promptly, upon demand, reimburse LESSOR for any additional premium charged for such policy by reason of LESSEE's failure to comply with the provisions of this Paragraph. LESSEE shall not do or permit anything to be done in or about the Premises which will in any way obstruct or interfere with the rights of other lessees or occupants of the 2040 BUILDING, or injure or annoy them, or use or allow the Premises to be used for any unlawful purposes nor shall LESSEE cause, maintain or permit any nuisance in, on or about the Premises. LESSEE shall not commit or suffer to be committed any waste in or upon the Premises.

6. SERVICES AND UTILITIES: Provided that LESSEE is not in default hereunder,

and subject to Paragraphs 2.4 and 2.5, LESSOR agrees to furnish to the Premises during generally recognized business days, and during hours determined by LESSOR in its sole discretion, and subject to the Rules and Regulations of the 2040 BUILDING, electricity for normal desk top office equipment and normal copying equipment, and heating, ventilation and air conditioning ("HVAC") as required in LESSOR's judgment for the comfortable use and occupancy of the Premises. Factors used by LESSOR in determining the length of time utilities will be furnished for comfortable use and occupancy of the premises will be: 1) customary usage in the area; 2) costs of additional provision of utilities; 3) customary business hours; and, 4) intent of the parties. If LESSEE desires HVAC at any other time, subject to Paragraphs 2.4 and 2.5, LESSOR shall use reasonable efforts to furnish such service upon reasonable notice from LESSEE and LESSEE shall pay LESSOR's charges there for on demand. Subject to Paragraphs 2.4 and 2.5, LESSOR shall also maintain and keep lighted the common stairs, common entries and restrooms in the 2040 BUILDING. LESSOR shall not be in default hereunder or be liable for any damages directly or indirectly resulting from,

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nor shall the Rent be abated by reason of (i) the installation, use or interruption of use of any equipment in connection with the furnishing of any of the foregoing services; (ii) failure to furnish or delay in furnishing any such services where such failure or delay is caused by accident or any condition or event beyond the reasonable control of LESSOR, or by the making of necessary repairs or improvements to the Premises, or BUILDING; or (iii) the limitation, curtailment or rationing of, or restrictions on, use of water, electricity, gas or any other form of energy serving the Premises, or BUILDING; LESSOR shall not be liable under any circumstances for a loss of or injury to property or business, however occurring, through or in connection with or incidental to failure to furnish any such services. If LESSEE uses heat generating machines or equipment in the Premises which affects the temperature otherwise maintained by the HVAC system, LESSOR reserves the right to install supplementary air conditioning units in the Premises and the cost thereof, including the cost of installation, operation and maintenance thereof, shall be paid by LESSEE to LESSOR upon demand by LESSOR.

LESSOR shall not be liable for telephone installation, equipment or any expenses incurred

by LESSEE for the installation, operation or maintenance of such equipment.

LESSEE shall not, without the written consent of LESSOR, use any apparatus or device in the Premises, including without limitation, electronic data processing machines, punch card machines or machines using in excess of 120volts, which consumes more electricity than is usually furnished or supplied for the use of premises as general and medical office space, as determined by LESSOR. LESSEE shall not connect any apparatus requiring electric current except through existing electrical outlets in the Premises. LESSEE shall not consume water or electric current in excess of that usually furnished or supplied for the use of premises as general and medical office space (as determined by LESSOR), without first procuring the written consent of LESSOR, which LESSOR may refuse, and in the event of consent, LESSOR may have installed a water meter or electrical current meter in the Premises to measure the amount of water or electric current consumed. The cost of any such meter and of its installation, maintenance and repair, shall be paid for by the LESSEE and LESSEE agrees to pay LESSOR promptly upon demand for all such water and electric current consumed as shown by said meters at the rates charged for such services by the local public utility company plus any additional expense incurred in keeping account of the water and electric current so consumed. If a separate meter is not installed, the excess cost for such water and electric current shall be established by an estimate made by a utility company or electrical engineer hired by LESSOR at LESSEE's expense. In determining whether or not LESSEE is consuming excessive utilities, LESSOR will consider customary usage in both the 2040 BUILDING and the area.

Nothing contained in this Paragraph shall restrict LESSOR's right to require at any time,

separate metering of utilities furnished to the Premises. In the event utilities are separately metered, LESSEE shall pay promptly upon demand for all utilities consumed at utility rates charged by the local public utility plus any additional expense incurred by LESSOR in keeping account of the utilities so consumed. LESSEE shall be responsible for the maintenance and repair of any such meters at its sole cost.

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Subject to Paragraphs 2.4 and 2.5, LESSOR shall furnish elevator service, lighting replacement for BUILDING standard lights, restroom supplies, window washing and janitor services in a manner that such services are customarily furnished to comparable office buildings in the area.

7. CONDITION OF THE PREMISES: LESSEE's taking possession of the Premises

shall be deemed conclusive evidence that as of the date of taking possession, the Premises are in good order and satisfactory condition, except for such matters as to which LESSEE gave LESSOR notice on or before the possession date. No promise of LESSOR to alter, remodel, repair or improve the Premises or the 2040 BUILDING and no representation, express or implied, respecting any matter or thing relating to the Premises, 2040 BUILDING or this Lease (including, without limitation, the condition of the Premises or the 2040 BUILDING) have been made to LESSEE by LESSOR, other than as may be contained herein or in a separate exhibit or addendum signed by LESSOR and LESSEE.

8. CONSTRUCTION. REPAIRS AND MAINTENANCE:

a. Subject to Paragraphs 2.4 and 2.5, the LESSOR shall maintain in good order,

condition and repair, the 2040 BUILDING and all other portions of the Premises not the obligation of LESSEE or of any other tenant in the 2040 BUILDING.

b. LESSEE'S Obligations.

(1) LESSEE, at LESSEE's sole expenses shall, except for services

furnished by LESSOR pursuant to Paragraph 6 hereof, maintain the Premises in good order, condition and repair, save for normal and ordinary wear and tear, including interior surfaces of the ceilings, walls and floors, all doors, all interior windows, all plumbing, pipes and fixtures, electrical wiring, switches and fixtures, BUILDING Standard furnishings and special items and equipment installed by or at the expense of LESSEE.

(2) LESSEE shall be responsible for all repairs and alterations in and to

the Premises, 2040 BUILDING and the facilities and systems thereof, the need for which arises out of (i) LESSEE's use or occupancy of the Premises; (ii) the installation, removal, use or operation of LESSEE's Property (as defined in Paragraph 10) in the Premises; (iii) the moving of LESSEE's Property into or out of the BUILDING; or (iv) the act, omission, misuse or negligence of LESSEE, its agents, or employees.

(3) If LESSEE fails to maintain the Premises in good order, condition and

repair, save for normal and ordinary wear and tear, LESSOR shall give LESSEE notice to do such acts as are reasonably required to so maintain the Premises. If LESSEE fails to promptly commence such work and diligently prosecute it to completion, than LESSOR shall have the right to do such acts and expend such funds at the expense of LESSEE as are reasonably required to perform such work. Any amount so expended by LESSOR shall be paid by LESSEE, promptly after demand with interest as provided in Paragraph 3, from the date of such work, but not to exceed the maximum rate

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when allowed by law. LESSOR shall have no liability to LESSEE for any damage, inconvenience or interference with the use of the Premises by LESSEE as a result of performing any such work.

c. Compliance with Law. LESSOR and LESSEE shall each do all acts required

to comply with all applicable Nevada laws, ordinances, and rules of any public authority relating to their respective maintenance obligations as set forth herein.

d. Load and Equipment Limits. LESSEE shall not place a load upon any floor of

the Premises which exceeds the load per square foot which such floor was designed to carry. The cost of any such pre-determination made by LESSOR's structural engineer shall be paid for by LESSEE, within fifteen (15) days, upon demand. LESSEE shall not install business machines or mechanical equipment which cause noise or vibration to such a degree it’s to be objectionable to LESSOR or other 2040 BUILDING Lessees.

e. Except as otherwise expressly provided in this Lease, LESSOR shall have no

liability to LESSEE nor shall LESSEE's obligations under this Lease be reduced or abated in any manner, whatsoever, by reason of any inconvenience, annoyance, or interruption to business arising from LESSOR's making any repairs or changes which LESSOR is required or permitted by this Lease or by any other Lessee's lease or required by law to make in or to any portion of the 2040 BUILDING or Premises. LESSOR shall never the less use reasonable efforts to minimize any interference with LESSEE's business in the Premises.

f. LESSEE shall give LESSOR promptly verbal notice followed by written

notice, of any damage to or defective condition in any part of appurtenance of the 2040 BUILDING's mechanical, electrical, plumbing, HVAC or other systems serving, located in, or passing through the Premises.

g. Upon the expiration or earlier termination of this Lease, LESSEE shall return the

Premises to LESSOR broom clean and in the same condition as on the date LESSEE took possession, except for normal and ordinary wear and tear. Any damage to the Premises, including any structural damage, resulting from LESSEE's use or from the removal of LESSEE's property pursuant to Paragraph 10b shall be repaired by LESSEE at LESSEE's expense.

9. ALTERATIONS AND ADDITIONS:

a. LESSEE shall not make any additions, alterations or improvements to the

Premises without obtaining the prior written consent of LESSOR. LESSOR's consent may be conditioned on LESSEE's removing any such additions, alterations or improvements upon the expiration of the Term and restoring the Premises to the same condition as on the date LESSEE took possession. All work with respect to any addition, alteration or improvement, shall be done in a good and workmanlike manner by properly qualified and licensed personnel approved by LESSOR, and such work shall be diligently prosecuted to completion. LESSOR may, at LESSOR's option, and per LESSEE specifications, require that any such work be performed by LESSOR's contractor, in

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which case, LESSEE shall pay the cost of such work shall within ten (10) days after presentation of the invoice for the work.

b. LESSEE shall pay the costs of any work done on the Premises pursuant to

Paragraph 9a and shall keep the Premises free and clear of liens of any kind. LESSEE shall be financially responsible to defend against and keep LESSOR free from all liability, loss, damage, costs, attorneys' fees and any other expense incurred on account of claims by any person performing work or furnishing materials or supplies for LESSEE. LESSEE shall keep LESSEE’s leasehold interest, and any additions or improvements which are or become the property of LESSOR under this Lease, free and clear of all attachment or Judgment liens. Before the actual commencement of any work for which a claim or lien may be filed, LESSEE shall give LESSOR notice of the intended commencement date a sufficient time before that date to enable LESSOR to post notices of non-responsibility of any other notices which LESSOR deems necessary for the proper protection of LESSOR’s interest in the Premises, 2040 Building, and LESSOR shall have the right to enter the Premises and post such notices at any reasonable time.

c. LESSOR may require, that LESSEE provide to LESSOR, at LESSEE's

expense, a lien and completion bond in an amount equal to at least one and one-half (1-1/2) times the total estimated cost of any additions, alterations or improvements to be made in or to the Premises, to protect LESSOR against any liability for mechanic's and material men's liens, and to ensure timely completion of the work. Nothing contained in this Paragraph 9c shall relieve LESSEE of its obligations under Paragraph 9b to keep the Premises, 2040 BUILDING free of all liens.

d. Unless their removal is required by LESSOR as provided in Paragraph 9a, all

additions, alterations and improvements made to the Premises shall become the property of LESSOR and be surrendered with the Premises upon the expiration of the Term, provided, however, LESSEE'S Property may be removed, subject to the provisions of Paragraph 10b.

10. LEASEHOLD IMPROVEMENTS- LESSEE'S PROPERTY:

a. All fixtures, equipment, improvements and appurtenances attached to or built

into the Premises at the commencement of or during the Term, whether or not by or at the expense of LESSEE ("Leasehold Improvements"), shall be and remain a part of the Premises, shall be the property of LESSOR and shall not be removed by LESSEE, except as expressly provided for in Paragraph 10b.

b. All movable partitions, business and trade fixtures, machinery and equipment,

communications equipment and office equipment located in the Premises and acquired by or for the account of LESSEE, without expense to LESSOR, which can be removed without structural damage to the 2040 BUILDING, and all furniture, furnishings and other articles of movable personal property owned by LESSEE and located in the Premises (collectively "LESSEE's Property") shall

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be and shall remain the property of LESSEE and may be removed by LESSEE at any time during the Term, provided that if any of LESSEE's property is removed, LESSEE shall promptly repair any damage to the Premises or to the 2040 BUILDING resulting from such removal.

11. RULES AND REGULATIONS: LESSEE agrees to comply with (and cause its

agents, contractors, employees and invitees to comply with), the Rules and Regulations attached hereto as Exhibit "A" and with such reasonable modifications thereof and additions thereto as LESSOR may from time to time make. LESSOR shall not be responsible for any violation of said Ru1es and Regulations by other lessees or occupants of the 2040 BUILDING. If LESSOR elects to change the Rules and Regulations, LESSOR shall give LESSEE fifteen (15) days' written notice prior to enforcement of such changes.

12. CERTAIN RIGHTS RESERVED BY LESSOR: LESSOR reserves the following

rights, exercisable without liability to LESSOR for (a) damage or injury to property, person or business; (b) causing an actual or constructive eviction from the Premises; or (c) disturbing

LESSEE's use or possession of the Premises:

a. To change the name or street address of the 2040 BUILDING; b. To install and maintain all signs on the exterior and interior of the 2040

Building;

c. To have pass keys to the Premises and all doors within the Premises, excluding LESSEE's vaults and safes;

d. At any time during the Term, and on reasonable prior notice to LESSEE, to

inspect the Premises, and to show the Premises to any prospective purchaser or mortgagee of 2040 BUILDING, or to any assignee of any mortgage on the 2040 BUILDING, or to others having an interest in the 2040 BUILDING, and during the last six (6) months of the Term, to show the Premises to prospective lessees thereof; and

e. To enter the Premises for the purpose of making inspections, repairs,

alterations, additions or improvements to the Premises or the 2040 BUILDING (including, without limitation, checking, calibrating, adjusting or balancing controls and other parts of the HVAC system), and to take all steps as may be necessary or desirable for the safety, protection, maintenance or preservation of the Premises or the 2040 BUILDING or LESSOR's interest therein, or as may be necessary or desirable for the operation or improvement of the 2040 BUILDING or in order to comply with laws, orders or requirements of governmental or other authority. LESSOR agrees to use its best efforts (except in emergency), to minimize interference with LESSEE's business in the Premises in the course of any such entry.

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13. ASSIGNMENT AND SUBLETTING: LESSEE shall not assign this Lease or sublease all or any part of the Premises without the express written approval of a duly authorized representative of LESSOR.

14. TERMINATION: In the event LESSEE remains in possession of the Premises after

termination pursuant to Paragraph 1, either party may terminate such month-to-month tenancy by giving the other party not less than thirty (30) days' advance written notice of the date of termination.

15. HOLDING OVER: If, after the termination date, LESSEE remains in possession of

the Premises with LESSOR's permission (express or implied), LESSEE's "Monthly Installments of Base Rent" payable to LESSOR shall be increased to one hundred twenty five percent (125%) of the Monthly Installments of the Base Rent payable by LESSEE at the termination date. Such monthly rent shall be payable in advance on or before the first day of each month.

16. SURRENDER OF PREMISES:

a. LESSEE shall peaceably surrender the Premises to LESSOR on the

Termination Date, in broom-clean condition and in as good condition as when LESSEE took possession, except for: (i) normal and ordinary wear and tear; (ii) loss by fire or other casualty loss, when such loss is not the result of the negligence or willful misconduct of LESSEE or LESSEE's agents, employees, contractors, licensees or invitees; and (iii) loss by condemnation. LESSEE shall, on LESSOR's request, remove LESSEE's Property on or before the Termination Date and promptly repair all damage to the Premises or 2040 BUILDING caused by such removal.

b. If LESSEE abandons or surrenders the Premises, or is dispossessed by

process of law or otherwise, any of LESSEE's Property left on the Premises shall be removed by LESSEE within fifteen (15) days. If LESSEE does not remove its Property within fifteen (15) days, LESSOR may remove LESSEE's Property. If LESSOR elects to remove all or any part of LESSEE's Property, the cost of removal, including repairing any damage to the Premises or 2040 BUILDING caused by such removal, shall be paid by LESSEE. On the Termination Date, LESSEE shall surrender all keys to the Premises.

17. DESTRUCTION OR DAMAGE: a. If the Premises or the portion of the 2040 BUILDING necessary for LESSEE's occupancy is damaged by fire, earthquake, act of God, the elements or other casualty, LESSOR shall, subject to Paragraphs 2.4 and 2.5 and to the provisions of this Paragraph, promptly repair the damage, if such repairs can, in LESSOR's opinion, be completed within ninety (90) days. If LESSOR determines that repairs can be completed within ninety (90) days, this Lease shall remain in full force and effect, except that if such damage is not the result of the negligence or willful misconduct of LESSEE or LESSEE's agents, employees, contractors, licensees or invitees, the Base Rent shall be abated to the extent LESSEE's use of the Premises is impaired, commencing with the date of damage and continuing until completion of the repairs required of LESSOR under Paragraph 17d.

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b. If, in LESSOR's opinion, such repairs to the Premises or portion of the 2040 BUILDING necessary for LESSEE's occupancy cannot be completed within ninety (90) days, LESSOR may elect, upon notice to LESSEE given within thirty (30) days after the date of such fire or casualty, to repair such damage, in which event this Lease shall continue in full force and effect, but the Base Rent shall be partially abated as provided in Paragraph 17a. If LESSOR does not so elect to make such repairs, this Lease shall terminate as of the date of such fire or casualty. c. If any other portion of the 2040 BUILDING is totally destroyed or damaged to the extent that in LESSOR's opinion repair thereof cannot be completed within ninety (90) days, LES.SOR may elect, upon notice to LESSEE given within thirty (30) days after the date of such fire or other casualty, to repair such damage, in which event, this Lease shall continue in full force and effect, but the Base Rent shall be partially abated as provided in Paragraph 17a. If LESSOR does not elect to make such repairs, this Lease shall terminate as of the date of such fire or casualty, provided that such damage affects the Premises occupied by LESSEE.

d. If the Premises are to be repaired under this Paragraph, subject to Paragraphs 2.4 and 2.5, LESSOR shall repair at its cost, any injury or damage to the 2040 BUILDING and 2040 BUILDING Standard Work in the Premises. LESSEE shall be responsible at its sole cost and expense for the repair, restoration and replacement of any other Leasehold Improvements and LESSEE's Property. LESSOR shall not be liable for any loss of business, inconvenience or annoyance arising from any repair or restoration of any portion of the Premises or 2040 BUILDING as a result of any damage from fire or other casualty.

e. This Lease shall be considered an express agreement governing any case of

damage to or destruction of the Premises or 2040 BUILDING by fire or other casualty.

18. EMINENT DOMAIN:

a. If the whole of the 2040 BUILDING or Premises is lawfully taken by condemnation or in any other manner for any public or quasi-public purpose, this Lease shall terminate as of the date of such taking, and Rent shall be prorated to such date. If less than the whole of the 2040 BUILDING or Premises is taken, this Lease shall be unaffected by such taking, providing that (i) LESSEE shall have the right to terminate this lease by notice to LESSOR given within ninety (90) days after the date of such taking if thirty-seven percent (37%) or more of the Premises is taken and the remaining area of the Premises is not reasonably sufficient for LESSEE to continue operation of its business; and (ii) LESSOR shall have the right to terminate this Lease by notice to LESSEE given within ninety (90) days after the date of such taking, if twenty-five percent (25%) or more of the 2040 BUILDING is taken and the remaining area is not reasonably sufficient for LESSOR to continue operation of its business. If either LESSOR or LESSEE so elects to terminate this Lease, the Lease shall terminate on the ninetieth (90th) day after either such notice. The Rent shall be

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pro-rated to the date of termination. If this Lease continues in force upon such partial taking, the Base Rent shall be equitably adjusted according to the remaining Rentable Area of the Premises or 2040 BUILDING.

b. In the event of any taking, partial or whole, all of the proceeds of any award,

Judgment or settlement payable by the condemning authority shall be the exclusive property of LESSOR, and LESSEE hereby assigns to LESSOR all of its right, title and interest in any award, Judgment or settlement from the condemning authority. LESSEE, however, shall have the right, to the extent that LESSOR's award is not reduced or prejudiced, to claim from the condemning authority' (but not from LESSOR) such compensation as may be recoverable by LESSEE in its own right for relocation expenses and damage to LESSEE's personal property.

c. In the event of a partial taking of the Premises which does not result in a

termination of this Lease, and subject to the availability of appropriated funds, LESSOR shall restore the remaining portion of the Premises as nearly as practicable to its condition prior to the condemnation or taking, but only to the extent of2040 BUILDING Standard Work. LESSEE shall be responsible at its sole cost and expense, for the repair, restoration and replacement of any other Leasehold Improvements and LESSEE's Property.

19. INDEMNIFICATION:

a. To the extent authorized by law, LESSEE, shall indemnify and hold LESSOR harmless and shall be financially responsible to LESSOR for loss or damage to LESSOR's property for any injury to or death sustained by LESSOR'S employees, officers or agents arising out of:

(1) Any breach or default by LESSEE of any of LESSEE's obligations under this Lease; and/or

(2) Any negligent act or omission of LESSEE, its officers, employees or

agents. LESSEE shall defend itself in any action or proceeding arising from any such claim.

b. LESSOR, subject to NRS Chapter 41 and Paragraphs 2.4 and 2.5, above, shall be financially responsible to LESSEE for loss or damage to LESSEE's property and for any injury to or death sustained by LESSEE or its employees arising out of:

(1) Any work, activity or other things allowed or suffered by LESSOR to be

done in, on or about the Premises;

under this Lease; or (2) Any breach or default by LESSOR of any of LESSOR's obligations

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(3) Any negligent or otherwise tortious act or omission of LESSOR, its officers or employees. LESSOR shall, at LESSOR's expense, defend itself in any action or proceeding arising from such claim.

c. LESSEE shall not be liable for any damages arising from any act or omission of

any other lessee of the 2040 BUILDING.

· d. LESSOR shall not be liable for any damages arising from any act or omission of any other lessee of the 2040 BUILDING. 20. LESSEE’S INSURANCE: The Summary of LESSEE’s Insurance Coverage will be submitted at the time of execution of this Lease by LESSEE to LESSOR. ·

21. WAIVER OF SUBROGATION: LESSOR and LESSEE each hereby waives all

rights of recovery against the other and against the officers, employees, agents and representatives of the other, on account of loss by or damage to the waiving party or its property or the property of others under its control, to the extent that such loss or damage is insured against under any fire and extended coverage insurance policy which either may have in force at the time of the loss or damage. LESSEE shall, upon obtaining the policies of insurance through its self-funded program, or commercial insurance, give notice to its insurance carrier or Risk Management Officer that the foregoing mutual waiver of subrogation is contained in this Lease.

22. SUBORDINATION AND ATTORNMENT: Upon written request of LESSOR or

any first mortgagee or trustee under a first deed of trust, LESSEE shall, in writing, subordinate its rights under this Lease to the lien of any first mortgage or first deed of trust, and to all advances made or hereafter to be made thereunder. However, before signing any subordination agreement, LESSEE shall have the right to obtain from any lender requesting such subordination, an agreement in writing providing that, as long as LESSEE is not in default hereunder, this Lease shall remain in effect for the full Term. The holder of any security interest may, upon written notice to LESSEE, elect to have this Lease prior to its security interest regardless of the time of the granting or recording of such security interest.

In the event of any foreclosure sale, transfer in lieu of foreclosure or termination of any lease in

which LESSOR is LESSEE, LESSEE shall attorn to the purchaser, transferee or lessor as the case may be, and recognize that party as LESSOR under this Lease, provided such party acquired and accepts the Premises subject to this Lease.

23. LESSEE ESTOPPEL CERTIFICATES: Within ten (10) days after written request

from LESSOR, LESSEE shall execute and deliver to LESSOR or LESSOR's designee, a written statement certifying (i) that this Lease is unmodified and in full force and effect, or is in full force and effect as modified and stating the modifications; (ii) the amount of Base Rent and the date to which Base Rent and additional rent have been paid in advance; (iii) the amount of any Security Deposit; and (iv) that LESSOR is not in default hereunder or, if LESSOR is claimed to be in default,

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stating the nature of any claimed default. Any such statement may be relied upon by a purchaser, assignee or lender. LESSEE's failure to execute and deliver such statement within the time required shall, at LESSOR's election, be a default under this Lease and shall also be conclusive upon LESSEE that:

(1) his Lease is in full force and effect and has not been modified except as represented by LESSOR; (2) there are no uncured defaults in LESSOR’s performance and that LESSEE has no rightof offset, counterclaim or deduction against Rent; and (3) no more than one month’s Rent has been paid in advance.

24. TRANSFER OF LESSOR’S INTEREST: In the event of any sale of transfer by LESSOR of the Premises or 2040 BUILDING, and assignment of this Lease by LESSOR shall be and is hereby entirely freed and relieved of any and all liability and obligations contained in or derived from this Lease arising out of any act, occurrence or omission relating to the Premises, 2040 BUILDING, or Lease occurring after the consummation of such sale or transfer, providing the purchaser shall expressly assume all of the covenants and obligations of LESSOR under this Lease. If any Security Deposit or prepaid Rent has been by LESSEE, LESSOR may transfer the Security Deposit or prepaid Rent to LESSOR’s successor and, upon such transfer, LESSOR shall be relieved of any and all further liability with respect thereto, in the same manner as security deposits are applicable to dwellings under NRS Chapter 118A. 25. DEFAULT:

25.1 LESSEE's Default. The occurrence of any one of the following events shall constitute a default and breach of this Lease by LESSEE:

a. If LESSEE abandons or vacates the Premises before the expiration or

earlier termination of the Lease; or

b. If LESSEE fails to pay any Rent or any other charges required to be paid by LESSEE under this Lease and such failure continues for ten (10) days after such payment is due and payable; or

c. If LESSEE fails to promptly and fully perform any other covenant,

condition or agreement contained in this Lease and such failure continues for ninety (90) days after written notice thereof from LESSOR to LESSEE; or

d. If a Writ of Attachment or Execution is levied on this Lease or on any of

LESSEE's Property; or

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e. If LESSEE makes a general assignment for the benefit of creditors, or provides for an arrangement, composition, extension or adjustment with its creditors; or

f. If LESSEE files a voluntary petition for relief or if a petition against

LESSEE in a proceeding under the federal bankruptcy laws or other insolvency laws is filed and not withdrawn or dismissed within forty-five (45) days thereafter, or if under the provisions of any law providing for reorganization or winding up of corporations, any court of competent jurisdiction assumes jurisdiction, custody or control of LESSEE or any substantial part of its property and such jurisdiction, custody or control remains in force unrelinquished, unstayed or unterminated for a period of forty-five (45) days; or ·

g. If in any proceeding or action in which LESSEE is a party, a trustee,

receiver, agent or custodian is appointed to take charge of the Premises or LESSEE's Property (or has the authority to do so) for the purpose of enforcing a lien against the Premises or LESSEE's Property.

25.2 Remedies. In the event of LESSEE's default hereunder, then in addition to

any other rights or remedies LESSOR may have under any law, LESSOR shall have the right, at LESSOR's option, with ninety (90) days' written notice to terminate this Lease and LESSEE's right to possession of the Premises and re-enter the Premises and take possession thereof, and LESSEE shall have no further claim to the Premises under this Lease.

The waiver by LESSOR of any breach of any term, covenant or condition of

this Lease shall not be deemed a waiver of such term, covenant or condition or any subsequent breach of the same or any other term, covenant or condition. Acceptance of Rent by LESSOR subsequent to any breach hereof shall not be deemed a waiver of any preceding breach other than the failure to pay the particular Rent so accepted, regardless of LESSOR's knowledge of any breach at the time of such acceptance of Rent. LESSOR shall not be deemed to have waived any term, covenant or condition unless LESSOR gives LESSEE written notice of such waiver.

25.3 LESSOR's Default. Subject to Paragraph 31, and Paragraphs 2.4 and 2.5, if

LESSOR fails to perform any covenant, condition or agreement contained in this Lease within ninety (90) days after receipt of written notice from LESSEE specifying such default, or if such default cannot reasonably be cured within ninety (90) days, if LESSOR fails to commence to cure within that ninety (90) day period, or thereafter shall fail to prosecute such cure with all reasonable diligence, then subject to Paragraphs 2.4 and 2.5, LESSOR shall be liable to LESSEE for any damages sustained by LESSEE as a result of LESSOR's breach.

If, after proper notice to LESSOR of default, LESSOR (or any first mortgagee or

first deed of trust beneficiary of LESSOR) fails to cure the default as provided herein, then LESSEE shall have the right to terminate the Lease.

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26. NOTICES: All notices, approvals and demands permitted or required to be given under this Lease shall be in writing and deemed duly serviced or given if personally delivered or sent by certified or registered U.S. mail, postage prepaid and addressed as follows: (i) if to LESSOR: Chief Executive Officer, 1800 West Charleston Boulevard, Las Vegas, Nevada 89102; and (ii) if to LESSEE: Daniel L. Orr, D.D.S., M.S., Ltd., 2040 West Charleston Boulevard, Suite 201, Las Vegas, Nevada, 89102. LESSOR and LESSEE may from time to time, by notice to the other, designate another place for receipt of future notices.

27. LESSOR'S CONSENT AND CONFIRMATION: The parties hereby agree, that any

provision herein requiring consent and/or confirmation of the LESSOR in writing or otherwise, may be given on behalf of LESSOR as follows:·

a. In matters concerning additions, alterations, and improvements to the premises

that are nonstructural in nature, consent may be given by the Chief Executive Officer of University Medical Center of Southern Nevada on behalf of LESSOR.

b. With regards to consent and/or confirmation as required under paragraphs 6, 9a,

9b, 9c, consent and/or confirmation may be given by the Chief Executive Officer of University Medical Center of Southern Nevada. In all other matters, consent shall be given by the Board of Hospital Trustees for LESSOR.

28. GOVERNMENT ENERGY OR UTILITY CONTROLS: In the event of imposition

of federal, state or local government controls, rules, regulations or restrictions on the use of consumption of energy or other utilities during the Term, both LESSOR and LESSEE shall be bound thereby. In the event of a difference in the interpretation by LESSOR and LESSEE of any such controls, the interpretation of the controlling agency shall prevail, and LESSOR shall have the right to enforce compliance therewith, including the right of entry into the Premises to effect compliance.

29. RELOCATION OF PREMISES: LESSOR shall have the right to relocate LESSEE

to another part of the 2040 BUILDING in accordance with the following:

a. The new premises shall be the same or larger in size, dimensions, configuration, decor and nature as the Premises described in this Lease, and if the relocation occurs after the Commencement Date, shall be placed in that condition by LESSOR at its cost, subject to Paragraphs 2.4 and 2.5;

b. LESSOR shall give LESSEE at least thirty (30) days' written notice of

LESSOR's intention to relocate LESSEE;

c. As nearly as practicable, the physical relocation of LESSEE shall take place on a weekend and shall be completed before the following Monday. If the physical relocation has not been completed in that time, Base Rent shall abate in full from the time the physical relocation

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commences to the time it is completed. Upon completion of such relocation, the new premises shall become the "Premises" under this Lease;

d. All reasonable costs incurred by LESSEE as a result of the relocation

shall be paid by LESSOR, subject to Paragraphs 2.4 and 2.5;

e. The parties hereto shall immediately execute an amendment to this Lease setting forth the relocation of the new Premises.

30. QUIET ENJOYMENT: LESSEE, upon paying the Rent and performing all of

obligations under this Lease, shall peaceably and quietly enjoy the Premises, subject to the terms of this Lease and to any mortgage, lease or other agreement to which this Lease may be subordinate.

31. FORCE MAJEURE: Any prevention, delay or stoppage of work to be performed

by LESSOR or LESSEE which is due to strikes, labor disputes, inability to obtain labor, materials, equipment or reasonable substitutes therefore, acts of God, governmental restrictions or regulations or controls, judicial orders, enemy or hostile government actions, civil commotion, fire or other casualty, or other causes beyond the reasonable control of the party obligated to perform hereunder, shall excuse performance of the work by that party for a period equal to the duration of that prevention, delay or stoppage. Nothing in this Paragraph shall excuse or delay LESSEE's obligation to pay Rent or other charges under this Lease except as to Paragraph 17 above.

32. CURING LESSEE'S DEFAULTS: If LESSEE defaults in the performance of

any of its obligations under this Lease, LESSOR may (but shall not be obligated to), without waiving such default, perform the same for the account at the expense of LESSEE. LESSEE shall pay LESSOR all costs of such performance promptly upon receipt of a bill therefor.

33. SIGN CONTROL: Except as provided for in Exhibit A, LESSEE shall not

affix, paint, erect or inscribe any sign, projection, awning, signal or advertisement of any kind to any part of the Premises, 2040 BUILDING or Project, including, without limitation, the inside or outside of windows, or doors, without the written consent of LESSOR. In determining whether or not LESSEE may affix, paint, install, erect or inscribe any sign or advertisement, LESSOR will consider the professional image of the premises, the infringement on other tenant's rights and space, the quality of the proposed workmanship, and the customary signage in the professional environment. LESSOR shall have the right to remove any signs or other matter, installed without LESSOR's permission, without being liable to LESSEE by reason of such removal, and to charge the cost of removal to LESSEE, as additional rent hereunder, payable within ten (10) days of written demand by LESSOR.

34. MISCELLANEOUS:

a. Accord and Satisfaction: Allocation of Pavment. No payment by LESSEE or receipt by LESSOR of a lesser amount than the Rent provided for in this Lease shall be deemed

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to be other than on account of the earliest due Rent, nor shall any endorsement or statement on any check or letter accompanying any check or payment as Rent be deemed an accord and satisfaction, and LESSOR may accept such check or payment without prejudice to LESSOR's right to recover the balance of the Rent or pursue any other remedy provided for in this Lease. In connection with the foregoing, LESSOR shall give notice of such application immediately.

b. Captions, Articles and Paragraph Numbers. The captions appearing within

the body of this Lease have been inserted as a matter of convenience and for reference only and in no way define, limit or enlarge the scope of meaning of this Lease. All references to Article/ Paragraph numbers refer to Articles or Paragraphs in this Lease. Article and Paragraph for the purposes of this Lease, have the same meaning.

c. Changes Requested by Lender. Neither LESSOR nor LESSEE shall unreasonably withhold its consent to changes or amendments to this Lease requested by the lender on LESSOR's interest, so long as these changes do not alter the basic business terms of this Lease or otherwise materially diminish any rights or materially increase any obligations of the party from whom consent to such change or amendment is requested. Said changes are subject to LESSOR'S Board of Hospital Trustees' approval.

d. Choice of Law. This Lease shall be construed and endorsed in accordance with the laws of the State of Nevada.

e. Consent. Notwithstanding anything contained in this Lease to the contrary, the parties shall have no claim, and hereby waive the right to any claim against the other for money damages by reason of any refusal, withholding satisfaction, (except estoppel certificates as provided for in Paragraph 23 above). In such event, the parties' only remedies therefor shall be an action for specific performance, injunction or declaratory judgment to enforce any right to such consent.

f. Counterparts. This Lease may be executed in multiple counterparts, all of which constitute one and the same Lease.

g. Execution of Lease; No Option. The submission of this Lease to LESSEE

shall be for examination purposes only, and does not constitute a reservation of or option for LESSEE to lease, or otherwise create any interest of LESSEE in the Premises or any other premises within the 2040 BUILDING. Execution of this Lease by LESSEE and its return to LESSOR shall not be binding on LESSOR notwithstanding anytime interval, until LESSOR has in fact signed and delivered this Lease to LESSEE.

h. Furnishing of Financial Statements; LESSEE's Representations. In order to

induce LESSOR to enter into this Lease, LESSEE agrees that it shall promptly furnish LESSOR, from time to time, upon LESSOR's written request, with financial statements reflecting LESSEE's current financial condition. LESSEE represents and warrants that all financial statements, records and information furnished by LESSEE to LESSOR in connection with this Lease are true, correct

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and complete in all respects. LESSOR acknowledges and accepts that LESSEE has only one (1) · annual audit performed and LESSOR shall accept said annual audit pursuant to this Agreement. i. Prior Agreements; Amendments. This Lease together with all exhibits, contains all of the agreements of the parties with respect to any matter covered or mentioned in this Lease, and supersedes any prior lease, and no prior agreement or understanding pertaining to any such matter shall be effective for any purpose. No provisions of this Lease may be amended or added to except by an agreement, in writing, signed by the parties or their respective successors in interest with the same formality attending the original.

j. Recording. LESSEE shall not record this Lease without the prior written consent of LESSOR, which consent shall not be unreasonably withheld. LESSEE, upon the request of LESSOR, shall execute and acknowledge a "short form" memorandum of this Lease for recording purposes. k. Severabilitv. A final determination by a Court of competent jurisdiction that any provision of this Lease is invalid shall not affect the validity of any other provision. l. Successors and Assigns. This Lease shall apply to and bind the partners, officers and permitted successors and assigns of the parties as provided in this Lease. m. Time of the Essence. Time is of the essence of this Lease. n. Waiver. No delay or omission in the exercise of any right or remedy of LESSEE or LESSOR upon any default by LESSEE or LESSOR shall impair such right or remedy or be construed as a waiver of such default. o. Third Party Liability. LESSOR and/or LESSEE, including any of the respective agents or employees, shall not be liable to third parties for any act or omission of the other party.

The receipt and acceptance by LESSOR of delinquent Rent shall not constitute a waiver of

any other default; it shall constitute only a waiver of timely payment for the particular Rent payment involved.

No act or conduct of LESSOR, including, without limitation, the acceptance of keys to the

Premises, shall constitute an acceptance of the surrender of the Premises by LESSEE before the expiration of the Term. Only a written notice from LESSOR to LESSEE shall constitute acceptance of the surrender of the Premises.

LESSOR's and/or LESSEE's consent to or approval of any act by LESSOR or LESSEE

requiring LESSOR's or LESSEE's consent or approval shall not be deemed to waive or render unnecessary LESSOR's or LESSEE's consent to or approval of any subsequent act by LESSEE.

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Any waiver by LESSOR or LESSEE of any default must be in writing and shall not be a waiver of any other default concerning the same or any other provision of the Lease.

The individuals signing this Lease on behalf of LESSOR and LESSEE have been duly

authorized and empowered to execute this Lease, and by their signatures shall bind LESSOR and LESSEE to perform all the obligations set forth in this Lease.

The parties hereto have executed this Lease as of the dates as set forth below.

LESSOR: LESSEE:

University Medical Center of Southern Nevada

Daniel L. Orr, D.D.S, M.S., Ltd.

Mason VanHouweling Daniel L. Orr, D.D.S., M.S. Chief Executive Officer President Date: Date:

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EXHIBIT "A"

Rules and Regulations

1. Lessor agrees to furnish Lessee two keys to the Premises at the same cost charged to Lessor for the additional keys.

2. Lessee will refer all contractors, contractor's representatives and installation technicians,

rendering any service on or to the Premises for Lessee, to Lessor for Lessor's approval and supervision before performance of any contractual service. This provision shall apply to all work performed in the Building or Project, including installation of telephones, telegraph, equipment, electrical devices and attachments and installations of any nature affecting floors, walls, woodwork, trim, windows, ceilings, equipment or any other physical portion of the Building or Project.

3. No Lessee shall at anytime occupy any part of the Building or Project as sleeping or lodging

quarters.

4. Lessee shall not place, install or operate on Premises or in any part of the Building or Project, any engine, stove or machinery, or conduct mechanical operations or cook thereon or therein, or place or use in or about Premises any explosives, gasoline, kerosene, oil, acids, caustics, or any other inflammable, explosive, or hazardous material without prior written consent of Lessor.

5. Lessor will not be responsible for lost or stolen personal property, equipment, money or

jewelry from Lessee's area or public rooms regardless of whether such loss occurs when area is locked against entry or not.

6. No bird, fowl, dogs, animals or pets or any kind shall be brought into or kept in or about the

Building or Project.

7. Lessor will not permit entrance to Lessee's offices by use of passkey controlled by Lessor, to any person at any time without written permission by Lessee, except employees, contractors, or service personnel directly supervised or employed by Lessor.

8. None of the entries, passages, doors, elevators, hallways or stairways shall be blocked or

obstructed or any rubbish, litter, trash or material of any nature placed, emptied, or thrown into these areas, nor shall such areas be used at any time except for ingress or egress by Lessee, Lessee's agents, employees or invitees.

9. The water closets any other water fixtures shall not be used for any purpose other than those for

which they were constructed. No person shall waste water by interfering with the faucets or otherwise.

10. No person shall disturb the occupants of the Building or Project by the use of any musical instruments, the making of raucous noises, or other unreasonable use.

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11. Nothing shall be thrown out of the windows of the Building or Project, or down the stairways or other passages.

12. Lessee shall not store any materials, equipment, products, etc. outside the Premises.

13. Lessee shall not erect any sign or other insignia upon or in any part of the Building or

Project, or other portion of the Premises without prior written consent of the Lessor.

14. Lessee shall comply with all local and federal codes and ordinances. In the event of fire or code problems, Lessee shall correct the problems, as required.

15. Lessee and its agents, employees and invitees shall observe and comply with the driving and

parking signs and markers on the Project grounds and surrounding areas.

16. Corridor and passage doors when not in use shall be kept closed.

17. All deliveries of other than hand-carried items must be made via the service entrances and service elevators. Any deliveries of any abnormally large, bulky or voluminous nature, such as furniture, office machinery, etc., can be made only after obtaining approval from the lessor and at those times specified by the Lessor.

18. Directories will be placed by the Lessor, at Lessor's expense, in the Building and no other

directories shall be permitted.

19. No signs, draperies, shutters, window coverings, decorations, hangings or obstructions of any type shall be placed on any skylights or on any doors or windows which are visible from outside the Premises without the prior written consent of the Lessor.

20. The Lessor reserves the right to rescind any of these rules and make such other and further

rules and regulations as in the judgment of Lessor shall from time to time be needed for safety, protection, care and cleanliness of the Project, the operation thereof, the preservation of good order therein, and the protection and comfort of its Lessees, their agents, and employees, including but not limited to, rules and regulations regarding hours of access to the Building or Project, which rules when made and notice thereof given to a Lessee shall be binding upon it in like manner as if originally herein prescribed. In the event of any conflict, inconsistency or other difference between the terms and provisions of these rules and regulations and any lease now or hereafter in effect between Lessor and any Lessee in the Building, Lessor shall have the right to rely on the term or provision in either such lease or such Rules and Regulations which is most restrictive on such Lessee and most favorable to Lessor.

21. There shall be no smoking in any part of the building at any time.

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AGREEMENT FOR PROFESSIONAL SERVICES

This Agreement, made and entered into this 20th day of January, 2016, by and between University Medical Center of Southern Nevada, a publicly owned and operated hospital created by virtue of Chapter 450 of the Nevada Revised Statutes (hereinafter referred to as “Hospital”) and Hanger Prosthetics & Orthotics, Inc. d/b/a Hanger Clinic, a professional corporation, engaged in the practice of providing prosthetic, orthotic and halo services and existing under and by virtue of the laws of the State of Nevada, with its principal place of business at 4615 W. Flamingo Rd., Las Vegas, NV 89103 (hereinafter referred to as the “Provider”);

WHEREAS, Hospital’s inpatients are in need of prosthetic, orthotic and halo services, as more fully described herein (“Services”);

WHEREAS, Provider has the necessary expertise to provide such Services and desires to contract for and provide said professional services to Hospital; and

WHEREAS, the parties desire to provide a full statement of their agreement in connection with the operation of Services in Hospital during the term of this Agreement.

NOW THEREFORE, in consideration of the covenants and mutual promises made herein, the parties agree as follows: I. PROVIDER'S OBLIGATIONS

1.01 Coverage. Provider hereby agrees to perform the following Services as requested by Hospital and in a manner reasonably satisfactory to Hospital:

a. Provider shall provide professional services in the best interests of Hospital's inpatients

with all due diligence.

b. Provider shall perform all work as may be necessary to complete this Agreement in a satisfactory and acceptable manner, and unless otherwise provided, shall furnish all transportation, materials, equipment, tools, labor or incidentals necessary to complete the work in the best possible and most expeditious manner.

c. Provider shall provide Services on an on-call basis to meet the needs of Hospital’s

inpatients.

1. Provider shall respond via telephone to all calls within fifteen (15) minutes.

2. If requested to appear, Provider shall respond on-site and administer services within one (1) hour including but not limited to trouble shooting or assisting with the application/fitting of equipment at Hospital.

The decision as to whether Provider must appear in person or consult by telephone is at the sole discretion of the appropriately designated contact of Hospital.

d. Provider shall coordinate the schedules and assignments of the clinicians to Services. At

no time will Services be without coverage.

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1.02 Other Responsibilities. a. Contribute to a positive relationship among Hospital’s Administration, Health Care

Providers (RN’s, ancillary providers), Hospital’s Medical Staff and the community.

b. Represent the Services at Hospital medical staff meetings and at Hospital department meetings as requested by Hospital.

c. Participate in Quality Assurance and Performance Improvement activities, related to

provided services, by monitoring and evaluating care; communicating findings, conclusions, recommendations and actions taken; and using established Hospital mechanisms for appropriate follow-up.

d. Provide education on contracted services to Medical Staff and Hospital personnel,

residents and medical students as requested by Hospital

1.03 Clinical Staff. a. Provider: Individuals must be certified by the American Board for Certification of

Orthotics and Prosthetics (“ABCOP”) or the Board for Orthotist/Prosthetist Certification (“BOC”). Provider shall at all times hereunder, be a member in good standing of Hospital’s medical staff with appropriate clinical privileges and appropriate Hospital credentialing. Any Provider who fails to maintain staff appointment of clinical privileges in good standing will not be permitted to render services to Hospital’s inpatients and will be replaced promptly by Provider.

b. Allied Health Providers: Individuals employed or utilized by Provider, if any, must apply

for privileges and remain in good standing in accordance with the University Medical Center of Southern Nevada’s Allied Health Providers Manual and Human Resource Policies as applicable to the Allied Health Provider.

c. Certification: Provider shall employ experienced staff who possess ABCOP or BOC

certification. Provider may employ staff who are certification eligible to assist certified practitioners in fitting or adjusting devices. If Provider employs certification eligible staff, Provider will ensure that the certification eligible staff are supervised at all times and are not allowed to work alone or independently with patients.

d. Continuing Education: On an annual basis, Provider will provide Hospital with evidence

of completion of required continuing education credits, if applicable, for all staff. e. Staff List: Provider shall provide a current list of staff including credentials with updates

provided in the event of staffing changes. f. Staff Contact: Provider shall provide Hospital with a twenty-four (24) hour-a-day, seven

(7) day-a-week toll-free telephone number(s) or accept collect charges. g. Reassignment: Hospital may require Provider to reassign staff whose performance is

unsatisfactory, whose personal characteristics prevent desirable relationships within Hospital, whose conduct may have a detrimental effect on patients, or who does not adhere

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to the existing rules and regulations of Hospital. Provider shall resolve the issue(s) or reassign the staff member within ten (10) days of Hospital's request for reassignment.

h. UMC Policies #I-66 and #EH 6.1: Provider shall ensure that its staff and equipment

utilized at Hospital, if any, are at all times in compliance with University Medical Center’s Policies #I-66 and #EH 6.1, set forth in Attachment D, incorporated and made a part hereof by this reference.

1.04 Standards of Performance.

a. Provider promises to adhere to Hospital's established standards and policies for providing

good patient care. In addition, Provider shall ensure that its staff shall also operate and conduct themselves in accordance with the standards and recommendations of The Joint Commission, all applicable, National Patient Safety Goals, the Bylaws, Rules and Regulations of the Hospital, and the CMS Conditions of Participation, as may then be in effect.

b. Hospital expressly agrees that the professional services of Provider may be performed by

such clinicians as Provider may associate with, so long as Provider has obtained the prior written approval of Hospital. So long as Provider is performing the services required hereby, its employed or contracted clinicians shall be free to perform private practice at other offices and hospitals. If any of Provider's clinicians are employed by Provider under the J-1 Visa waiver program, Provider will so advise Hospital, and Provider shall be in strict compliance, at all times during the performance of this Agreement, with all federal laws and regulations governing said program and any applicable state guidelines.

c. Provider shall maintain professional demeanor and not violate Hospital’s Code of

Conduct, policies or procedures. d. Provider will participate in interdisciplinary decision making with Hospital's staff as it

relates to the Providers’ services. e. Provider shall assist Hospital with improvement of customer satisfaction and

performance ratings. f. Provider shall be one hundred percent (100%) compliant with all standards related to

medical records. g. The parties will meet on a quarterly basis or as needed basis to review Provider’s

performance.

1.05 Scope of Services.

a. Provider shall provide fixation, prosthetic, orthotic and halo devices, to Hospital’s inpatients who are referred to Provider by Hospital.

b. Provider shall provide proper fitting of the delivered device to the patient.

c. Patients can follow-up with Provider after discharge for fitting adjustments.

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d. Provider will provide follow-up care six (6) months after discharge via telephone or letter to the patient. Provider will not be responsible for patients who reject follow-up care.

e. Provider shall be required to maintain complete records on each patient and properly

document the patient’s medical chart as necessary.

f. Provider shall have daily communication with Hospital’s designated contact responsible for the particular service to be provided by Provider.

g. Invoices need to be signed by Hospital appointed staff acknowledging receipt.

h. Provider shall make patient rounds on a bi-weekly basis or as requested.

i. Provider will contact and notify appropriate Hospital Rehabilitation Office Specialist,

Physical Therapist or Occupational Therapist on fitting and delivery of device.

j. Provider will provide sufficient education to the patient and/or the patient’s family to safely and effectively utilize the device(s) as well as furnishing written instructions.

k. Provider shall provide in-service training to Hospital’s staff.

1.06 Devices.

a. Fixation devices including but not limited to spinal, cervical, thoracic, lumbar, sacral, halo (MRI compatible); and

b. Prosthetic and orthotic devices as follows:

1. Foam and plastic cervical collars;

2. Spinal orthoses;

3. Scoliosis and spinal fracture girdles and body jackets;

4. Lower extremity orthoses (excluding splinting);

5. Upper extremity orthoses (excluding splinting);

6. Fracture/joint support bracing;

7. Lower extremity prosthetic appliances;

8. Upper extremity prostheses;

9. Diabetic shoes; and

10. Burn pressure garments.

c. When possible, fittings for braces shall be checked in both the standing and sitting position.

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d. During the initial fitting of braces, Provider will ensure that such device will properly fit

the patient inclusive of needed padding.

e. Prior to delivery, the devices shall be completely tested and serviced by Provider. In the event deficiencies are detected, Provider will make the necessary repairs, adjustments or replacements. Devices will be labeled with the Provider’s name, address and telephone number.

f. Provider shall maintain sufficient stock to supply all products covered by this Agreement

within the response time requirements specified in Paragraph 1.07.

g. The devices supplied pursuant to this Agreement must meet Medicaid/Medicare standards as outlined in the Medicare Region D Supplier Manual for Durable Medical Equipment, Prosthetics, Orthotics and Supplies. Halos shall be MRI compatible.

1.07 Response Time Requirement of Service.

a. Initial Measuring Visit; Re-fit or Replacement: Provider will respond to the requesting Hospital unit no later than two (2) hours following the placement of a telephonic order by Hospital's representative, twenty-four (24) hours-a-day, seven (7) days-a-week, including holidays. All orders will be placed through the Hospital’s Rehabilitation Services Department, or such other designated contact pursuant to written notification by the Hospital to Provider.

b. Delivery and Fitting: Devices will be delivered and fitted within twenty-four (24) hours upon placement of order.

c. Adjustments of Devices: Devices will be adjusted as often as necessary to ensure proper

fitting at no cost. The response time for adjustments to devices, if necessary, will be within two (2) hours of a telephonic request by Hospital's representative.

If necessary and if such adjustment needs to be done offsite, Hospital shall be able to return to Provider the device for adjustment, and have such device adjusted within two (2) hours and returned/refitted to the patient.

d. Custom Devices: Some prosthetic and orthotic devices may need to be customized. In

these instances, custom devices will be delivered within a maximum of two (2) business days. Hospital realizes that under rare circumstances some custom devices may take longer than two (2) business days. Provider will notify Hospital when a device falls under these circumstances and will advise Hospital of an approximate delivery date. During the custom fitting of the device on the patient, a Hospital Physical Therapist/Occupational Therapist/Registered Nurse, as appropriate, must be present.

e. Damaged or Defective Devices. Provider shall replace damaged or defective devices within four (4) hours from notice by Hospital at no cost to Hospital, including freight and any and all other associated costs. Failure to do so will cause such device(s) to be procured from another supplier. If the product is procured from another supplier, Provider shall reimburse Hospital the costs incurred for the procurement of such device(s) from such other supplier.

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f. Timeliness of Performance: Time is of the essence for both Hospital and Provider, and

failure to meet the time periods specified in this Section shall constitute a breach of contract.

1.08 Delivery of Service.

a. Provider shall deliver Services to Hospital inpatients at 1800 West Charleston Boulevard, Las Vegas, Nevada.

b. At the request of Hospital, some medical services may require special arrangements with the patient for delivery of devices.

1.09 Warranty.

a. Unless otherwise provided in this Agreement, all materials and equipment incorporated into any work covered by this Agreement shall be new and of the most suitable grade of their respective kinds for their intended use and all workmanship shall be in accordance with practices acceptable to Hospital. Unless otherwise provided in this Agreement, Provider warrants all equipment, materials and labor furnished or performed under this Agreement against defects in design, materials and workmanship for a period of ninety (90) days from and after final acceptance under this Agreement. Upon receipt of written notice from Hospital of any defect in any such equipment, materials or labor during the applicable warranty period, the affected item or parts thereof shall be redesigned, repaired or replaced by Provider in a time acceptable to Hospital as specified in Paragraph 1.07. This warranty does not include any major adjustments or refitting of a device due to anatomical changes such as weight loss or gain or due to further surgery.

b. Provider shall perform such tests as Hospital may require to verify that such redesign, repairs and replacements comply with the requirements of this Agreement. All costs incidental to such redesign, repair, replacement and testing, shall be borne by Provider. Provider warrants such redesigned, repaired or replaced work against defective design, materials and workmanship for a period of ninety (90) days from and after date of acceptance thereof.

c. Should Provider fail to promptly make the necessary redesign, repair, replacement or

tests, Hospital may perform or cause to be performed the same at Provider's expense. All devices shall be fitted to the best of Provider's ability.

1.10 Patent Indemnity.

a. Provider hereby indemnifies and shall defend and hold harmless Hospital and its representatives from and against all claims, losses, costs, damages, and expenses, including attorney's fees, incurred by Hospital and its representatives as a result of or in connection with any claims or actions based upon infringement or alleged infringement of any patent and arising out of the use of the equipment or materials furnished under this Agreement by Provider, or out of the processes or actions employed by, or on behalf of, Provider in connection with the performance of this Agreement. Provider shall, at its sole expense, promptly defend against any such claim

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or action unless directed otherwise by Hospital or its representatives provided that Hospital or its representatives shall have notified Provider upon becoming aware of such claims or actions. Provider's aforementioned obligations shall not apply to equipment, materials, or processes furnished or specified by Hospital or its representatives.

b. Provider shall have the right, in order to avoid such claims or actions, to substitute at its expense non-infringing equipment, materials, or processes, or to modify such infringing equipment, materials and processes so they become non-infringing, or to obtain the necessary licenses to use the infringing equipment, material or processes, provided that such substituted and modified equipment, materials and processes shall meet all the requirements and be subject to all the provisions of this Agreement.

1.11 Independent Contractor. Provider represents that it is fully experienced and properly qualified

to perform the class of work provided for herein and that it is properly licensed, equipped, organized and financed to fulfill the contract requirements. Provider shall act as an independent contractor and not as an agent of Hospital in performing this Agreement. Provider shall maintain complete control over its employees. Provider shall perform all work in accordance with its own methods subject to compliance with this Agreement.

1.12 Industrial Insurance.

a. As an independent contractor, Provider shall be fully responsible for premiums related to

accident and compensation benefits for its shareholders and/or direct employees as required by the industrial insurance laws of the State of Nevada.

b. Provider agrees, as a condition precedent to the performance of any work under this

Agreement and as a precondition to any obligation of Hospital to make any payment under this Agreement, to provide Hospital with a certificate issued by the appropriate entity in accordance with the industrial insurance laws of the State of Nevada (Attachment F). Provider agrees to maintain coverage for industrial insurance pursuant to the terms of this Agreement. If Provider does not maintain such coverage, Provider agrees that Hospital may withhold payment, order Provider to stop work, suspend the Agreement or terminate the Agreement.

1.13 Professional Liability Insurance. Provider shall carry professional liability insurance on its

officers and employees at its own expense in accordance with the minimums established by the Bylaws, Rules and Regulations of the Medical and Dental Staff. Said insurance shall annually be certified to Hospital’s Administration and Medical Staff, as necessary (Attachment F).

1.14 Non-exclusive Nature of Agreement. Hospital inpatients receiving Fixation Devices or

Prosthetic and/or Orthotic Devices from a vendor other than Provider as of the effective date of this Agreement will continue to be serviced by their current vendor to ensure continuity of care in the fitting and adjustment of their devices. Additionally, nothing in this Agreement shall be construed to interfere with the professional judgment of members of Hospital’s Medical Staff when determining the best interests of patients.

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1.15 Provider Personal Expenses. Provider shall be responsible for all its personal expenses, including, but not limited to, membership fees, dues and expenses of attending conventions and meetings, except those specifically requested and designated by Hospital.

1.16 Maintenance of Records.

a. All medical records, histories, charts and other information regarding patients treated or

matters handled by Provider hereunder, or any data or data bases derived therefrom, shall be the property of Hospital regardless of the manner, media or system in which such information is retained. Provider shall have access to and may copy relevant records upon reasonable notice to Hospital.

b. Provider shall complete all patient charts in a timely manner in accordance with the

standards and recommendations of The Joint Commission, CMS, and Regulations of the Medical and Dental Staff, as may then be in effect.

1.17 Health Insurance Portability and Accountability Act of 1996.

a. For purposes of this Agreement, “Protected Health Information” shall mean any

information, whether oral or recorded in any form or medium, that: (i) was created or received by either party; (ii) relates to the past, present, or future health condition of an individual, the provision of health care to an individual, or the past, present or future payment for the provision of health care to an individual; and (iii) identifies such individual.

b. Provider shall be part of an Organized Health Care Arrangement (“OHCA”) with UMC,

as such term is defined in the HIPAA Regulations (45 CFR Parts 160 and 164). Hospital shall make all reasonable efforts to obtain patient acknowledgment of the Joint Notice of Privacy Practices (JNPP) on behalf of the Hospital and Provider for all patients treated at the Hospital. Hospital and Provider may share a common patient’s Protected Health Information to enable the other party to provide treatment, seek payment, and engage in quality assessment and improvement activities, population-based activities relating to improving health or reducing health care costs, case management, conducting training programs, and accreditation, certification, licensing or credentialing activities, to the extent permitted by law or by the HIPAA Regulations, including the “minimum necessary” requirements (45 CFR 164.502(b)).

c. Hospital and Provider agree to implement appropriate administrative, physical, and

technical safeguards to preserve the confidentiality of Protected Health Information as outlined under the HIPAA Regulations. Provider’s employees agree to adhere to Hospital policies, procedures, and Medical Staff by-laws for maintaining the confidentiality of Protected Health Information when conducting treatment, payment, or other operations and activities at the Hospital.

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II. COMPENSATION

2.01 During the term of this Agreement, Provider shall directly bill the appropriate third party payor for all components, as applicable. Hospital shall provide usual social security and insurance information to facilitate billing.

2.02 Provider may bill Hospital for the Services reimbursed to Hospital through its inpatient

reimbursement rates with third party payors (e.g., DRG, per diem) and for self-pay patients where it has been verified by Hospital that there is not a viable source of reimbursement to Provider pursuant to Hospital’s policies and procedures. Additionally, the parties agree that in cases where the patient insurance coverage does not pay the Hospital through inpatient reimbursement rates as set forth in this Paragraph 2.02, typically third party payor fee-for-service contracts, then Hospital will contact the identified contracted provider of such third party payor directly for the required patient care services. If Hospital requests Services from Provider pursuant to Paragraph 1.07(a) instead of the payor’s identified contracted provider then Provider may also bill Hospital for the Services as set forth herein.

Such billing request must be submitted to Hospital within three (3) days of the determination

that no direct billing source is available to Provider. The billing request requires the submission of an:

i. Authorization Request Form (Attachment A); ii. appropriate HCPCS codes (Attachment B); and iii. if applicable, suitable proof of third party payor’s denial. If accepted by Hospital, Provider shall be paid in accordance with Paragraph 2.03,

hereinbelow. It is expressly agreed by the parties that the Services under this Agreement are only reimbursable by Hospital for inpatient referrals.

If Attachments A, B and, if applicable, proof of third party payor’s denial are not received

within such timeframe, Hospital has no obligation for payment of Provider services. For Provider claims that cannot be processed or have been denied by Hospital, Hospital shall complete the Reimbursement Denial Form (Attachment C) and submit to Provider within seven (7) business days with supporting documentation, if applicable.

2.03 During the term of this Agreement and subject to Paragraph 4.06 hereinbelow, Hospital will

compensate Provider as follows:

a. The Nevada Medicaid durable medical equipment price (DMERC Codes) less twenty-five percent (25%) of current year.

b. Unlisted Codes (codes without established allowables) reimbursed at 50% billed charges.

2.04 The following services are included in the Services and do not incur additional charges:

a. Adjustments.

b. Prosthetic evaluation and patient education for post operation amputation patients.

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c. During the initial fitting of braces, Provider will ensure that such device will properly fit the patient inclusive of needed padding for elderly or extremely thin patients.

2.05 Hospital will issue a purchase order to Provider for the term of the Agreement. Invoices are to be

sent to Hospital’s Accounts Payable Department. Payment of invoices will be made within ninety (90) calendar days, unless otherwise specified, after receipt of an accurate invoice that has been reviewed and approved by the applicable Department’s authorized representative.

2.06 Provider shall pay all freight charges. Provider shall bear all responsibility for the products

from the point of origin to delivery to the patient. All prices shall include delivery charges. 2.07 Hospital is not a payor of last resort. Hospital is not responsible for payment of co-pays, co-

insurance and/or deductibles. Hospital is not responsible for payment where the patient has a third party payor who denies the claim or does not cover the services provided. In the event a third party payor's reimbursement rates are less than Hospital's reimbursement rates, Hospital is not responsible for payment of the difference between the third party payor's rates and Hospital's rates. Hospital is not responsible for payment for unapproved devices.

III. TERM/MODIFICATIONS/TERMINATION

3.01 Term of Agreement. This Agreement shall become effective on February 1, 2016, and, subject to Paragraph 4.06, hereinbelow, shall remain in effect through January 31, 2019. Hospital reserves the option to temporarily extend this Agreement for any reason for up to ninety (90) calendar days following its expiration.

3.02 Modifications. Provider shall notify Hospital in writing of:

a. Any change of address of Provider;

b. Any change in membership or ownership of Provider's group or professional corporation;

c. Any action against the license of any of Provider’s professional staff;

d. Any action commenced against Provider which could materially affect this Agreement;

e. Any exclusionary action initiated or taken by a federal health care program against

Provider or any of Provider’s professional staff; or

f. Any other occurrence known to Provider that could materially impair the ability of Provider to carry out its duties and obligations under this Agreement.

3.03 Termination For Cause.

This Agreement shall terminate upon written notice by Hospital, upon the occurrence of any one of the following events:

a. Either party may terminate this Agreement in the event of the other party's material

breach hereof; provided, however, that termination for breach shall not become effective unless and until the non-terminating party has been given written notice of such breach describing the nature of the breach with sufficient specificity to permit its

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cure, and such party shall have failed to have cured such breach to the reasonable satisfaction of the other within thirty (30) days following said notice.

b. In the event any insurance required to be maintained by either party to this Agreement is cancelled or not renewed, or in the event either party loses any license, permit or other legal entitlement necessary to lawfully perform its obligations hereunder, such party shall immediately notify the other and this Agreement shall be deemed terminated effective immediately.

c. In the event of nonpayment by Hospital of any material amount due hereunder,

Provider may terminate this Agreement upon ten (10) days' written notice.

d. In the event a party files a voluntary petition in bankruptcy or makes an assignment for the benefit of creditors or otherwise seeks relief from creditors under any federal or state bankruptcy, insolvency, reorganization or moratorium statute, or is the subject of an involuntary petition in bankruptcy which is not dismissed with prejudice within sixty (60) days of its filing, the other party may terminate this Agreement immediately.

3.04 Termination Without Cause. Either party may terminate this Agreement, without cause, upon

ninety (90) days written notice to the other party. If Hospital terminates this Agreement, Provider waives any cause of action or claim for damages arising out of or related to the termination.

IV. MISCELLANEOUS

4.01 Access to Records. Upon written request of the Secretary of Health and Human Services or the Comptroller General or any of their duly authorized representatives, Provider shall, for a period of four (4) years after the furnishing of any service pursuant to this Agreement, make available to them those contracts, books, documents, and records necessary to verify the nature and extent of the costs of providing its services. If Provider carries out any of the duties of this Agreement through a subcontract with a value or cost equal to or greater than $10,000 or for a period equal to or greater than twelve (12) months, such subcontract shall include this same requirement. This section is included pursuant to and is governed by the requirements of the Social Security Act, 42 U.S.C. ' 1395x (v) (1) (I), and the regulations promulgated thereunder.

4.02 Amendments. No modifications or amendments to this Agreement shall be valid or enforceable

unless mutually agreed to in writing by the parties. 4.03 Assignment/Binding on Successors. No assignment of rights, duties or obligations of this

Agreement shall be made by either party without the express written approval of a duly authorized representative of the other party. Subject to the restrictions against transfer or assignment as herein contained, the provisions of this Agreement shall inure to the benefit of and shall be binding upon the assigns or successors-in-interest of each of the parties hereto and all persons claiming by, through or under them.

4.04 Audits. The performance of this contract by the Provider is subject to review by the Hospital to

insure contract compliance. The Provider agrees to provide the Hospital any and all information requested that relates to the performance of this contract. All requests for information shall be in writing to the Provider. Time is of the essence during the audit process. Failure to provide the information requested within the timeline provided in the written information request may be

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considered a material breach of contract and be cause for suspension and/or termination of the contract.

4.05 Authority to Execute. The individuals signing this Agreement on behalf of the parties have been

duly authorized and empowered to execute this Agreement and by their signatures shall bind the parties to perform all the obligations set forth in this Agreement.

4.06 Budget Act and Fiscal Fund Out. In accordance with the Nevada Revised Statutes (NRS

354.626), the financial obligations under this Agreement between the parties shall not exceed those monies appropriated and approved by Hospital for the then current fiscal year under the Local Government Budget Act. This Agreement shall terminate and Hospital's obligations under it shall be extinguished at the end of any of Hospital's fiscal years in which Hospital’s governing body fails to appropriate monies for the ensuing fiscal year sufficient for the payment of all amounts which could then become due under this Agreement. Hospital agrees that this section shall not be utilized as a subterfuge or in a discriminatory fashion as it relates to this Agreement. In the event this section is invoked, this Agreement will expire on the 30th day of June of the current fiscal year. Termination under this section shall not relieve Hospital of its obligations incurred through the 30th day of June of the fiscal year for which monies were appropriated.

4.07 Captions/Gender/Number. The articles, captions, and headings herein are for convenience and

reference only and should not be used in interpreting any provision of this Agreement. Whenever the context herein requires, the gender of all words shall include the masculine, feminine and neuter and the number of all words shall include the singular and plural.

4.08 Confidential Records. All medical records, histories, charts and other information regarding

patients, all Hospital statistical, financial, confidential, and/or personnel records and any data or data bases derived therefrom shall be the property of Hospital regardless of the manner, media or system in which such information is retained. All such information received, stored or viewed by Provider shall be kept in the strictest confidence by Provider and its employees and contractors.

4.09 Corporate Compliance. Provider recognizes that it is essential to the core values of Hospital that

its contractors conduct themselves in compliance with all ethical and legal requirements. Therefore, in performing its services under this contract, Provider agrees at all times to comply with all applicable federal, state and local laws and regulations in effect during the term hereof and further agrees to use its good faith efforts to comply with the relevant compliance policies of Hospital, including its corporate compliance program and Code of Ethics, the relevant portions of which are available to Provider upon request.

4.10 Entire Agreement. This document constitutes the entire agreement between the parties, whether

written or oral, and as of the effective date hereof, supersedes all other agreements between the parties which provide for the same services as contained in this Agreement. Excepting modifications or amendments as allowed by the terms of this Agreement, no other agreement, statement, or promise not contained in this Agreement shall be valid or binding.

4.11 False Claims Act.

a. The state and federal False Claims Act statutes prohibit knowingly or recklessly

submitting false claims to the Government, or causing others to submit false claims. Under the False Claims Act, a provider may face civil prosecution for knowingly

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presenting reimbursement claims: (1) for services or items that the provider knows were not actually provided as claimed; (2) that are based on the use of an improper billing code which the provider knows will result in greater reimbursement than the proper code; (3) that the provider knows are false; (4) for services represented as being performed by a licensed professional when the services were actually performed by a non-licensed person; (5) for items or services furnished by individuals who have been excluded from participation in federally-funded programs; or (6) for procedures which the provider knows were not medically necessary. Violation of the civil False Claims Act may result in fines of up to $11,000 for each false claim, treble damages, and possible exclusion from federally-funded health programs. Accordingly, all employees, volunteers, medical staff members, vendors, and agency personnel are prohibited from knowingly submitting to any federally or state funded program a claim for payment or approval that includes fraudulent information, is based on fraudulent documentation or otherwise violates the provisions described in this paragraph.

b. Hospital is committed to complying with all applicable laws, including but not limited to

Federal and State False Claims statutes. As part of this commitment, Hospital has established and will maintain a Corporate Compliance Program, has a Corporate Compliance Officer, and operates an anonymous 24-hour, seven-day-a-week compliance Hotline. A Notice Regarding False Claims and Statements is attached to this Agreement as Attachment E. Provider is expected to immediately report to Hospital’s Corporate Compliance Officer directly at (702) 383-6211, through the Hotline (888) 691-0772, or the website at http://umcsn.alertline.com, or in writing, any actions by a medical staff member, Hospital vendor, or Hospital employee which Provider believes, in good faith, violates an ethical, professional or legal standard. Hospital shall treat such information confidentially to the extent allowed by applicable law, and will only share such information on a bona fide need to know basis. Hospital is prohibited by law from retaliating in any way against any individual who, in good faith, reports a perceived problem.

4.12 Federal, State, Local Laws. Provider will comply with all federal, state and local laws and/or

regulations relative to its activities in Clark County, Nevada. 4.13 Financial Obligation. Provider shall incur no financial obligation on behalf of Hospital without

prior written approval of Hospital or the Governing Board or its designee.

4.14 Force Majeure. Neither party shall be liable for any delays or failures in performance due to circumstances beyond its control.

4.15 Governing Law. This Agreement shall be construed and enforced in accordance with the laws of

the State of Nevada.

4.16 Indemnification. Provider shall indemnify and hold harmless, Hospital, its officers and employees from any and all claims, demands, actions or causes of action, of any kind or nature, arising out of the negligent or intentional acts or omissions of Provider, its employees, representatives, successors or assigns. Provider shall resist and defend at its own expense any actions or proceedings brought by reason of such claim, action or cause of action. Provider’s obligation to indemnify and/or defend the other shall survive the termination of this Agreement if the incident requiring such indemnification or defense occurred during the Agreement term, or

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http://umcsn.alertline.com/

any extension thereof, and directly or indirectly relates to the Provider’s obligations or performance under the terms of this Agreement.

4.17 Interpretation. Each party hereto acknowledges that there was ample opportunity to review and comment on this Agreement. This Agreement shall be read and interpreted according to its plain meaning and any ambiguity shall not be construed against either party. It is expressly agreed by the parties that the judicial rule of construction that a document should be more strictly construed against the draftsperson thereof shall not apply to any provision of this Agreement.

4.18 Non-Discrimination. Provider shall not discriminate against any person on the basis of age,

color, disability, sex, handicapping condition (including AIDS or AIDS related conditions), disability, national origin, race, religion, sexual orientation, gender identity or expression, or any other class protected by law or regulation.

4.19 Notices. All notices required under this Agreement shall be in writing and shall either be served

personally or sent by certified mail, return receipt requested. All mailed notices shall be deemed received three (3) days after mailing. Notices shall be mailed to the following addresses or such other address as either party may specify in writing to the other party:

To Hospital: Chief Executive Officer

University Medical Center of Southern Nevada 1800 West Charleston Boulevard Las Vegas, Nevada 89102

To Provider: Hanger Prosthetics & Orthotics, Inc. d/b/a Hanger Clinic

P.O. Box 650846 Dallas, TX 75265-0846

Attn: Contracting With cc to: Hanger Clinic 4155 East La Palma Avenue, Suite B400 Anaheim, California 92807

Attn: SCA/SNV Contracts Manager

4.20 Publicity. Neither Hospital nor Provider shall cause to be published or disseminated any advertising materials, either printed or electronically transmitted which identify the other party or its facilities with respect to this Agreement without the prior written consent of the other party.

4.21 Performance. Time is of the essence in this Agreement.

4.22 Severability. In the event any provision of this Agreement is rendered invalid or unenforceable,

said provision(s) hereof will be immediately void and may be renegotiated for the sole purpose of rectifying the error. The remainder of the provisions of this Agreement not in question shall remain in full force and effect.

4.23 Third Party Interest/Liability. This Agreement is entered into for the exclusive benefit of the

undersigned parties and is not intended to create any rights, powers or interests in any third party. Hospital and/or Provider, including any of their respective officers, directors, employees or agents, shall not be liable to third parties by any act or omission of the other party.

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4.24 Waiver. A party’s failure to insist upon strict performance of any covenant or condition of this Agreement, or to exercise any option or right herein contained, shall not act as a waiver or relinquishment of said covenant, condition or right nor as a waiver or relinquishment of any future right to enforce such covenant, condition or right.

IN WITNESS WHEREOF, the parties have caused this Agreement to be executed on the day and year first above written.

Provider: Hospital:

Hanger Prosthetics & Orthotics, Inc. University Medical Center of Southern Nevada

By:________________________________ By:________________________________ Rebecca Hast Mason VanHouweling Chief Compliance Officer Chief Executive Officer

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Attachment A Authorization Request Form

Patient Name: ____________________________________________ DOB: ________________

Ordering Physician: _________________________________ Referral Date: ________________

REFERRED FROM

Physician / Physician Group: ______________________________________________________

Last Hospitalization: ___________________ Hospital Name: ______________________ (Date of Service)

CLINICAL INFORMATION

Diagnosis: ____________________________________________________________________

Estimated Treatment Plan: ________________________________________________________ _____________________________ Date: ________________ Time: _______________ UMC Clinical Approval _____________________________ Date: ________________ Time: _______________ UMC Eligibility Approval

COMPENSATION REQUEST Reason for Compensation Request:_________________________________________________ _____________________________ Date: ________________ Time: _______________ UMC Compensation Request Approval

PATIENT ACCESS – AUTHORIZATION Comments/Date/Admit Rep Signature

No payment source: Approved for UMC payment. Faxed approval to [Company Name]: _______ ______ Date Initials Return copy of authorization form with each charge sheet daily.

Submit treatment plan on-time.

Submit weekly treatment summary-each week.

1800 W. Charleston Blvd. Las Vegas, NV 89102 (702) 383-2000

Mason VanHouweling Chief Executive Officer

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Attachment B Charge Sheet

Prosthetic, Orthotic and Halo Services

[Patient Label]

SIM

DEPT RTX REV CENTER 7155

SIM DESCRIPTION / TREATMENTS HCPCS QTY

*Codes for the prevailing year is subject to change based on UMC's Charge Master. REV: 11/15 RN:______________________________ CHARGED BY: :______________________________



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Attachment C Reimbursement Denial Form

Date: To [Company Name]: You have submitted an Authorization Request Form and for the following reason(s) it will have denied charges: Provider was unable to submit the Authorization Request Form (Attachment A), Charge

Sheet (Attachment B) and, if applicable, proof of third party payor’s denial within three (3) days from determination that no direct billing source is available to Provider.

An Authorization Request Form (Attachment A) was not sent with the Charge Sheet

(Attachment B). Provider was unable to provide suitable proof on third party payor’s denial. This patient has appropriate third party payor insurance coverage.

This patient was not seen at UMC.

cc: Charge Sheet and Denial sent to UMC Accounts Payable UMC Physical Therapy



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Attachment D

Welcome to University Medical Center of Southern Nevada (UMC). We are excited that you have joined our group and look forward to working with you. Now that you have completed signing the contract and are ready to start, there are a few Human Resources related on-boarding/processing requirements that need to be completed. Many of the processes are time sensitive in relation to your start date. On-boarding a new contracted non-employee may take several weeks to complete depending on your status and we are, therefore, requesting your immediate attention.

If you are a Physician/APN/PA requiring medical credentialing, or shadowing a Physician as an observer only, please contact the Medical Staff office at (702) 383-2603. If you are a Physician eligible as defined in your contract to bring in support staff (Dependent Allied Health Personnel) that are non-credentialed (Nurses/Technician /Office Managers), please contact Human Resources at (702) 383-7884. All other contractors (except for Vendors) that will be bringing in staff to work on UMC property, please contact Human Resources at (702) 383-7884.

For more information on required documentation prior to starting work, please refer to the following attached policies:

Admin Policy I-66 “Contracted Non-Employees/Allied Health Non-Credentialed/Dependent Allied Health/Temporary Staff/Third Party Equipment”

Infection Control Policy 6.1 “Employee Health Program”

Thank you and we look forward to working with you. Human Resources Administration



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UNIVERSITY MEDICAL CENTER OF SOUTHERN NEVADA ADMINISTRATIVE POLICY AND PROCEDURE MANUAL

SUBJECT: Contracted Non-Employees /Allied Health Non- Credentialed /Dependent Allied Health / Temporary Staff / Construction/Third Party Equipment

ADMINISTRATIVE APPROVAL:

EFFECTIVE: 9/96

REVISED: 6/99; 10/01; 4/07; 1/08; 3/11; 5/14

POLICY #: I-66

AFFECTS: Organization wide

PURPOSE: To ensure that contractual agreements for the provision of services are consistent with the level of care defined by Hospital policy; and, to ensure the priority utilization of contracted services, staffing and equipment. POLICY:

1. All entities providing UMC with personnel for temporary staffing and Allied Health Providers must have a written contract that contains the terms and conditions required by this policy. Dependent Allied providers working with credentialed physicians without a contract must also abide by the policy.

2. All credentialed Physicians, Physician Assistants, Nurse Practitioners and other credentialed Allied Health personnel will abide by the policies and procedures as set by the Medical Staff Bylaws.

3. All equipment provided and used by outside entities must meet the safety requirements required by this policy.

4. Contract(s) will be developed collaboratively by the department(s) directly impacted, the service agency and the hospital Contracts Management department.

5. Contract(s) directly related to patient care must be reviewed and evaluated by the Medical Executive Committee to ensure clinical competency.

6. Contract(s) must be approved by the Chief Executive Officer or applicable board prior to the commencement of services.

TEMPORARY STAFFING: Contractual Requirements Contractor must meet and adhere to all qualifications and standards established by Hospital policies and procedures (including Administrative and Human resource related as applicable); The Joint Commission; and, all applicable regulatory and/or credentialing entities specific to services included in contract. In the event a contractor contracts with an individual who is certified under the aegis of the Medical and Dental Staff Bylaws or Allied Health, the contract must provide contracted individuals applicable education, training and licensure as appropriate for the assigned responsibilities. The contracted individual must fulfill orientation requirements consistent with other non-employee staff members. Records concerning the contracted individual shall be maintained by Hospital’s Department of Human Resources (HR) and the clinical department directly impacted by the services provided. HR will provide Employee Health and Organizational Development departments with an ongoing list of these individuals and the department in which they work.

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Laboratory Services All reference and contracted laboratory services must meet the applicable federal regulations for clinical laboratories and maintain evidence of the same. Healthcare Providers In the event a service agency employs or contracts with an individual who is subject to the Medical and Dental Staff Bylaws, or the Allied Health Providers Manual, the contract must provide the individual’s applicable education, training and licensure appropriate for his or her assigned responsibilities. The assigned individual must have an appropriate National Provider Identifier (NPI). Clinical Care Services Contractor may employ such Allied Health providers as it determines necessary to perform its obligations under the contract. For each such Allied Health provider, contractor shall be responsible for furnishing Hospital with evidence of the following:

1. Written job description that indicates:

a. Required education and training consistent with applicable legal and regulatory requirements and Hospital policy.

b. Required licensure, certification or registration as applicable.

c. Required knowledge and/or experience appropriate to perform the defined scope of practice, services and responsibilities.

2. Completed pre-employment drug screen and background check consistent with UMC’s contracted background check protocol. Testing should include HHS Office of Inspector General (OIG), Excluded Party List System (EPLS), sanction checks and criminal background. If a felony conviction exists, UMC’s HR department will review and approve or deny the Allied Health Practitioner’s access to UMC Campus. UMC will be given authorization to verify results online by contractor.

3. The following medical information must be provided to UMC and outlined by UMC Employee Health Department.

a. Evidence of annual TB testing (2 years), a current 2 step TB test, or an IGRA blood test. Individuals with a positive TB test must have proof of a past positive skin test, a negative sign and symptom review and a negative chest x-ray within the last 3 months.

b. Current seasons’ Influenza vaccine or UMC’s signed declination. All personnel will follow UMC’s

Influenza policy 6.5. (Influenza season is generally Oct-March 31st. Season is defined within policy).

c. dap vaccination is required for any personnel with contact in PEDS, PICU, PEDS ER, NICU, Labor and Delivery, FRC and FBCC.

d. Hepatitis B vaccine series (3 vaccines), or titers showing immunity or a declination for all personnel in clinical areas.

4. The following vaccines are highly suggested by UMC and the CDC for all healthcare workers and records are maintained and kept current at the agency. Contractor will provide UMC authorization to audit these files upon request.

a. Measles, mumps and Rubella (MMR) series (2 vaccines),or titers showing immunity;

b. Varicella vaccine series (2 vaccines), titer showing immunity or a history of disease;

c. Tdap vaccine (1 vaccine) for personnel not in areas listed above.

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5. The contractor will complete a competency assessment of the individual (1) upon hire, (2) at the time initial service is provided, (3) when there is a change in either job performance or job requirements and (4) on an annual basis.

a. Competency assessments of Allied Health providers must clearly establish that the individual meets all qualifications and standards established by Hospital policies and procedures, The Joint Commission and all other applicable regulatory and/or credentialing entities with specific application to the service provided.

b. Competency assessments of Allied Health providers must clearly address the ages of the patients served by the individual and the degree of success the individual achieves in producing the results expected from clinical interventions.

c. Competency assessments must include an objective, measurable system and be used periodically to evaluate job performance, current competencies and skills.

d. Competency assessments must be performed annually, allow for Hospital input and be submitted to Hospital’s HR department.

e. The competency assessment will include a competency checklist for each Allied Health provider position, which at a minimum addresses the individual’s:

i. Knowledge and ability required to perform the written job description; ii. Ability to effectively and safely use equipment; iii. Knowledge of infection control procedures; iv. Knowledge of patient age-specific needs; v. Knowledge of safety procedures; and vi. Knowledge of emergency procedures.

6. Contractor has conducted an orientation process to familiarize Allied Health providers with their jobs and with their

work environment before beginning patient care or other activities at UMC inclusive of safety and infection control. The orientation process must also assess each individual’s ability to fulfill the specific job responsibilities set forth in the written job description.

7. Contractor periodically reviews the individual’s abilities to carry out job responsibilities, especially when introducing new procedures, techniques, technology and/or equipment.

8. Contractor has developed and furnishes ongoing in-service and other education and training programs appropriate to patient age groups served by Hospital and defined within the scope of services.

9. Contractor submits to Hospital for annual review:

a. The level of competence of the contractor’s Allied Health providers that meets UMC standards; and

b. The patterns and trends relating to the contractor’s use of Allied Health providers.

10. Contractor ensures that each Allied Health provider has acquired an identification badge from Hospital’s HR department before commencing services at Hospital’s facilities; and ensures badge is returned to HR upon termination of service.

11. Contract requires the contractor, upon Hospital’s request, to discontinue the employment at Hospital’s facilities of an Allied Health provider whose performance is unsatisfactory, whose personal characteristics prevent desirable relationships with Hospital staff, whose conduct may have a detrimental effect on patients, or who fails to adhere to Hospital’s existing policies and procedures. HR will be notified so appropriate action can be taken to remove access.

Non Clinical Short Term Temporary Personnel Non clinical/short term personnel such as Engineering-related vendors and/or construction workers on site within the hospital for construction, remodeling or on property for new project implementation will be required to adhere to UMC Infection

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Control requirements as outlined below. Original records are to be maintained by the vendor. A copy will also be available within the appropriate department at UMC.

1. Evidence of annual TB testing (2 years), a current 2 step TB test, or an IGRA blood test. Individuals with a positive TB test must have proof of a past positive skin test, a negative sign and symptom review and a negative chest x-ray within the last 3 months.

2. Current seasons’ Influenza vaccine or UMC’s signed declination. All personnel will follow UMC’s Influenza policy

6.5. (Influenza season is generally Oct-March 31st. Season is defined within policy). Non Clinical Personnel Non Clinical personnel that are assigned to work at UMC by approved contracted agencies ( banks, gift shops, etc.) will be required to follow basic on-boarding requirements like UMC application, background check, drug screening, medical screening as outlined and attend orientation prior to working on premises. Personnel files will be maintained in Human Resources until the person ceases working on property. All annual testing and requirements will be required of these personnel. EQUIPMENT: In the event Hospital contracts for equipment services, documentation of a current, accurate and separate inventory equipment list must be provided to appropriate department to be included in Hospital’s medical equipment management program.

1. All equipment brought into UMC is required to meet the following criteria:

a. Electrical safety check which meets the requirements of Hospital’s Clinical Engineering department.

b. Established schedule for ongoing monitoring and evaluation of equipment submitted to Hospital’s Clinical Engineering department.

c. Monitoring and evaluation will include:

i. Preventive maintenance; ii. Identification and recordation of equipment management problems; iii. Identification and recordation of equipment failures; and iv. Identification and recordation of user errors and abuse.

d. Results of monitoring and evaluation shall be recorded as performed and submitted to Hospital’s

department of Clinical Engineering.

2. Documentation on each contractor providing medical equipment to assure users of equipment are able to demonstrate or describe:

a. Capabilities, limitations and special applications of the equipment;

b. Operating and safety procedures for equipment use;

c. Emergency procedures in the event of equipment failure; and

d. Processes for reporting equipment management problems, failures and user errors.

3. Documentation on each contractor providing medical equipment to assure technicians maintaining and/or repairing

the equipment can demonstrate or describe:

a. Knowledge and skills necessary to perform maintenance responsibilities; and

b. Processes for reporting equipment management problems, failures and user errors.

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MONITORING: The contractor will provide reports of performance improvement activities at defined intervals. A contractor providing direct patient care will collaborate, as applicable, with Hospital’s Performance Improvement Department regarding Improvement Organization Performance (IOP) activities. Process for Allied Health Provider working at UMC Hospital Campus

1. All Allied Health and Dependent Allied Health Provider personnel from outside contractors monitored by HR (non-credentialed/licensed) working at UMC will have the following documentation on file in Department of Human Resources:

a. Copy of contract

b. Copy of Contractor’s liability insurance (general and professional)

c. Job description

d. Resume’

e. Copy of current Driver’s License OR One 2x2 photo taken within two (2) years

f. Specialty certifications, Basic Life Support (BLS), Advanced Cardiac Life Support (ACLS), etc.

g. Current license verification/primary source verifications

h. Competency Statement/Skills Checklist (Contractor’s and UMC’s)

i. Annual Performance Evaluation(s)

j. UMC’s “Department Specific Orientation” form

k. Attestation form/letter from Contractor completed for medical clearances except for TB test and Influenza vaccine.

l. Completion of Non-Employee specific orientation

2. The following documents may be maintained at Contractor’s office:

a. Medical Information to include: History and Physical (H&P), Physical examination or certification from a licensed physician that a person is in a state of good health (Clinical Personnel), Annual Tuberculosis (TB) test or Chest X-Ray, Immunizations, Hepatitis B Series or waiver, Measles/Mumps/Rubella Immunizations or adequate titers, Chicken Pox questionnaire, drug tests results and other pertinent health clearance records as required. The results of these tests can be noted on a one (1) page medical attestation form provided by UMC. TB test results and Influenza vaccine must be submitted to Human Resources.

b. Attestation form must be signed by the employee and contractor. The form can be utilized to update information as renewals or new tests. The form must be provided to Hospital each time a new employee is assigned to UMC. Once the above criteria are met, the individual will be scheduled to attend orientation, receive an identification badge and IT security access.

c. Any and all peer references and other clearance verification paperwork must be maintained in the contractor’s office and be available upon request.

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Non-Employee Orientation– Provided by the Organizational Development Department

1. Non-Employee orientation must occur prior to any utilization of contracted personnel.

2. Orientation may be accomplished by attendance at non-employee orientation; or, by completion of the “Agency Orientation Manual” if scheduled by the Organizational Development Department.

3. Nurses must complete the RN orientation manual before working if Per Diem and within one (1) week of hire if a traveler nurse. RN orientation will be scheduled by the appropriate responsible UMC Manager.

4. Each contracted personnel will have a unit orientation upon presenting to a new area. This must be documented and sent to Organizational Development department. Components such as the PYXIS tutorial and competency, Patient Safety Net (PSN), Information Technology Services (IT), Glucose monitoring as appropriate and any other elements specific to the position or department.

Contractor Personnel Performance Guidelines

1. Arrive at assigned duty station at the start of shift. Tardiness will be documented on evaluation.

2. Complete UMC incident reports and/or medication error reports, when appropriate, using the PSN. The contractual individual is to report to the Director of their employer all incidents and medication errors for which they are responsible. UMC will not assume this responsibility. UMC agrees to notify Agency when an employee(s) is known to have been exposed to any communicable diseases.

Agency Personnel Assignment Guidelines

1. Duties will be assigned by the Physicians, Department Manager, and Charge Nurse/Supervisor that matches their skill level as defined on the competency checklist.

2. Administer care utilizing the standards of care established and accepted by UMC.

3. Be responsible to initiate update or give input to the plan of care on their assigned patients as defined in job description.

4. Will not obtain blood from the lab unless properly trained by the unit/department to do so. Training must be documented and sent to Organization Development department.

5. Administer narcotics as appropriate to position and scope of practice.

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UNIVERSITY MEDICAL CENTER OF SOUTHERN NEVADA INFECTION CONTROL POLICIES AND PROCEDURES

SUBJECT: Employee Health Program

ADMINISTRATIVE APPROVAL:

EFFECTIVE: 1/04

REVISED: 8/04, 8/09, 12/09, 1/10, 5/11/ 8/11, 5/13, 3/14

POLICY #: EH 6.1

AFFECTS: Organization wide

I. BACKGROUND

University Medical Center of Southern Nevada is concerned with the physical well being of its staff. The Employee Health Department provides services to staff in the areas of infection prevention, pre-employment screening, and environmental/health surveillance.

II. PURPOSE To define the scope and responsibility of the Employee Health Program. III. RESPONSIBILITY

University Medical Center’s Employee Health Program operates under the direction of Infection Control Department and the Medical Director of Epidemiology. In order to meet the needs of the institution and its staff, Employee Health Services operates out of Enterprise Quick Care and the Infection Control Departments. The Employee Health coordinators work together to provide a multifaceted approach to the Employee Health Program.

Services offered through Infection Control are:

• Annual TB Screening. • Annual FIT Testing. • Annual Influenza Vaccine Program • Employee Vaccination Program • Post Exposure Follow-up. • Coordinate Environmental/ Health Surveillance Programs. • Coordinate Education Programs related to employee health • Incoming UNSOM Residents TB screening, evaluation of immunizations, and mask fitting

Services offered through Enterprise are:

• New Hire Processing which includes vaccinations, TB screening, FIT testing and general health screening

• Evaluation for vaccinations and TB screening of volunteers at UMC • Credentialed Physicians TB screening • TB screening for contracted staff as directed through individual contracts • Maintenance of paper Employee Health Record.

In order to ensure smooth services are offered, both departments will coordinate and maintain employee health records, update policies and procedures, provide education, offer immunizations, screening and documentation as covered under the Employee Health Protocol orders of a physician. This policy is reviewed and approved through the Infection Control Committee. Employee Health will be active in the Infection Control Committee and provide

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appropriate reports to Infection Control as requested. The two departments will also work to minimize risks of infection and/or contagious disease transmission to patients, employees and public.

Employee Health Services are offered during normal business hours excluding weekends and holidays. Employee Health Services is available during all off hours for blood borne pathogen exposures consultation through the Infection Control Department or On Duty Administrators (see Blood and Body Fluid Exposure Protocol EH 6.2.)

Managers and Supervisors Responsibilities:

• Employees annual testing is completed within the time frame required for compliance with federal, state

and local laws. Managers/Supervisors must maintain communication with Employee Health Services to ensure their departments are in compliance. Those employees who are not in compliance will be subjected to progressive discipline within their department.

• Sending all employees return to work slips to Employee Health, Enterprise location. • Timely reporting of an employee’s infectious disease of epidemiological importance or

infectious illness to the Employee Health Nurse/ Infection Control Department. • Timely dissemination of the Employee Health Program information to all employees within their

division.

Employee Responsibilities:

• Report for all mandated scheduled annual TB screening, FIT testing, vaccinations, and any other employee health related events within the required time frame.

• Report any infectious diseases of epidemiological importance or infectious illness to the Employee Health Nurse/ Infection Control Department.

IV. PROCEDURES

A. Pre-employment Health Screening

Employment is contingent upon successful completion of a pre- employment health screening. Should significant medical problems be discovered which might hamper an employee’s ability to perform the job safely or effectively, employment may be denied. 1. Initial Employment Physical/Medical Screening (Mandatory)

All new employees are required to undergo a physical examination or medical screening prior to entering the work force. The physical will include a functional and physical assessment based on the job description. It will also include screening for contagious disease, review of lab work and other processes needed to determine if a potential employee is able to safely and effectively perform their job duties.

2. Initial TB screening

a. Initial TB Testing (Mandatory) See Administration of Mantoux TST - EHN Policy 6.4 All TB testing/screening follows CDC guidelines. 1) New hire employees needing TST testing must have a baseline two-step Purified

Protein Derivation (PPD) tuberculin skin test. If there is a documented negative skin test within the preceding 12 months, the employee would then require a single PPD skin test. If there is a documented negative TST within the preceding 12 months and another negative TST within approximately 30 days of hire, no further TST is required. If there is a documented negative 2 step TST within approximately 30 days of hire, no further TST is required.

2) Any employee who does not have a documented positive TB skin test and does not report any severe allergic reaction to testing, will receive TB skin testing. Employees who have had a BCG vaccine, are pregnant, or who are immunocompromised will be required to follow all TB testing requirements. Any

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immunocompromised new hire will complete a sign and symptom review in addition to the TB test.

3) New Hire employees with a documented history of a positive PPD skin test or quantiferon will require a chest x-ray and a sign and symptom review. A negative chest x-ray report, within the three months of hire, will be accepted. Counseling for latent TB will be provided by the physician unless employee has been counseled in the past for active or latent TB. Employees with a positive TB test, and

i. a negative chest x-ray, a negative sign and symptom reviews will be counseled for latent TB by the Employee Health physician, and be allowed to begin or return to work.

ii. a positive or questionable chest x-ray, and positive sign and symptom review will be sent to the SNHD for clearance. They will not be allowed to return to work until clearance is obtained.

iii. A negative chest x-ray and a positive sign and symptom review will be evaluated by the physician. After evaluation, the physician will determine if an employee may return to or begin work.

iv. All employees with a positive TB test will repeat a sign and symptom review annually.

4) *Documented history is documentation from a physician or other health care provider that documents a positive TB skin test; preferred documentation will be results noted in millimeters.

b. Quantiferon Testing (UMC does not perform Quantiferon testing on a regular basis but

accepts testing from other facilities or labs.) 1) A negative Quantiferon (from the last 12 months) can be considered the first step in a

2 step process. 2) If a negative Quantiferon lab result is from within the last 30 days, no further testing

needs to be performed. (This is considered the baseline 2 step.) 3) If a positive Quantiferon lab test is presented, steps listed above for new hires with a

documented history of a positive test will be followed.

3. Color Blindness Test: Testing is required for all Nursing and Laboratory personnel.

4. Initial FIT Test: All employees whose jobs are listed as Category I A and whose job duties are listed in the Airborne Pathogen Risk Assessment will be Fit tested for the N-95 Respirator. Education about the airborne exposure control plan will be provided. See Respiratory Protection Program for program details.

5. Vaccinations: ALL NEW HIRE VACCINATIONS ARE OUTLINED BELOW.

B. Vaccinations

For all vaccinations, the most current Vaccine Information Statements will be given. Documentation will be in the Employee Health database. All vaccinations will be entered into Nevada’s WEB IZ. All listed vaccines are provided at no cost to employee. All vaccines are given following CDC guidelines and manufacture instructions.

1. Tetanus-Diphtheria Toxoids and Pertussis vaccine (Td/Tdap):

• Tdap immunizations are highly recommended for all direct care providers as recommended by the CDC. Documentation of a current Tdap vaccine is recommended for all new hires that provide direct patient care. If the employee declines the vaccine, a declination form must be signed.

• Any employee sustaining an on the job injury that warrants a tetanus vaccine and does not have a current tetanus vaccine (within the last 10 years) should receive a Td vaccine or a Tdap vaccine. A Tdap will be given in place of a Td if the employee has not received a Tdap vaccine.

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• Employees who decline the vaccine are notified if exposed to pertussis. Once notification is received, they will be required to remain off work for 21 days (incubation period is 10 to 21 days). If no signs/symptoms in 21 days, the employee may return to work. If pertussis develops, the employee will remain at home until signs and symptoms of pertussis have waned. The employee must provide documentation from their Primary Medical Doctor (PMD) to return to work.

• All individuals with patient contact who have not been vaccinated for any reason will not be permitted to work if an urgent situation is declared. An Urgent Situation may be declared by the Medical Director of Epidemiology in consultation with Employee Health Services, and Infection Prevention and Control. Determination of an Urgent Situation may be based upon one or more of the following conditions:

a. Influx inpatient admissions attributable to pertussis; b. Advisories by local or state Department of Health officials or the Centers for

Disease Control and Prevention; c. Marked increase in employee absenteeism secondary to possible pertussis cases.

2. Measles, Mumps and Rubella

• All new hire employees and volunteers must provide documentation of 2 MMR vaccines or two mumps vaccines, two measles vaccines and one rubella vaccine. If documentation is not available titers for measles, mumps, and rubella will be drawn.

• Current employees should provide records of immunizations, titers or documentation of measles, mumps records or rubella upon request of EHN. If unable to provide such documentation, titers may be drawn.

• The vaccine will be given based on results of titers. For employees without laboratory evidence of immunity for measles and mumps, two doses of MMR will be given at least 4 weeks apart. For those lacking immunity to rubella, one dose of MMR will be given. Employees with documented medical reasons for not receiving the MMR may sign a declination form.

• Healthcare workers with two documented does of MMR, should not have titers drawn. If titers are drawn and results are negative or equivocal for measles, mumps and/or rubella healthcare workers should be considered to have preemptive evidence of immunity and are not in need or additional MMR doses.

3. Influenza Immunization Program: • UMC offers influenza vaccination annually to all staff and Licensed Independent

Practitioners (LIP). This vaccine is highly recommended for all health care professionals. Please see Influenza Vaccination Policy VI.

4. Chickenpox (Varicella) Screening • All employees will be screened for chickenpox. The employee must have

documentation of two Varicella vaccinations or provide history of chickenpox or herpes zoster based on physician diagnosis. If a positive history of chickenpox or herpes zoster is determined, no further work-up is needed

• If a negative or uncertain history of chickenpox disease is determined, a Varicella titer will be drawn. If FAMA (chickenpox titer) is negative employee will be offered the Varivax vaccine.

• Employees who decline the vaccine, or have no history of chickenpox are notified if exposed to chickenpox. Once notification is received, they may be required to remain off work for 21 days (incubation period is 10 to 21 days). If no signs/symptoms are present following the incubation period, the employee may return to work. If chickenpox develops, the employee will remain at home until all lesions have dried and crusted. The employee must provide documentation from their Primary Medical Doctor (PMD) to return to work.

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5. Hepatitis B Vaccines • The Hepatitis B Vaccine is available to all UMC employees who are at risk for exposure to

blood and body fluids (Category IB or IIB). Vaccination is encouraged unless there is documentation of the 3 part vaccine series, a titer showing immunity or if the vaccine is medically contraindicated.

• If no documentation of the series is available, a hepatitis B titer will be drawn. • If the titer is negative, the employee should begin the three part vaccine series. (dose #1

now, #2 in one month, and #3 approximately 5 months after #2) • If an employee declines the vaccine, a declination form must be signed. If an employee

initially declines the Hepatitis B vaccination, but later decides to accept the vaccination, the vaccination will then be made available. This documentation is kept in the Employee Health database.

• Hepatitis B titers will be drawn on all employees 1-2 months after receiving the third Hepatitis B vaccine dose.

C. Annual TB Screening (Mandatory): This program shall follow the CDC guidelines, OSHA regulations,

and State requirements as reviewed and approved by the Infection Control Committee. Non compliant employees will be subject to progressive discipline within their departments.

1. All employees who do not have a documented positive TST, will have a PPD test annually. The

annual PPD must be completed within the month of their last PPD per state regulations. Pregnant and immunocompromised employees will receive their annual PPD. Any immunocompromised employee may be asked to complete a sign and symptom review at the time of the TB test.

2. PPD skin tests will be read by the Employee Health Nurse or designee. All designees will be educated

and complete the on-line competency test. All positive PPD skin test must be confirmed by Employee Health or Infection Control.

3. Employees with a new positive PPD skin test or quantiferon will require a chest x-ray and a

sign and symptom review. Employees with a positive TB test and i. a negative chest x-ray, a negative sign and symptom reviews will be counseled for latent TB by the

Employee Health physician and referred to the employee’s private physician for decisions regarding treatment/medication of latent TB., These employees will be allowed to begin or return to work.

ii. a positive or questionable chest x-ray, and positive or negative sign and symptom review will be sent to the SNHD for clearance. They will not be allowed to return to work until clearance is obtained.

iii. A negative chest x-ray and a positive sign and symptom review will be evaluated by the Occupational Health physician. After evaluation, the physician will determine if an employee may return to or begin work or referred to a private MD for follow up.

iv. All employees with a positive TB test will repeat a sign and symptom review annually.

4. All employees with past positive TST or history of TB will be required to complete a sign and symptom survey. This survey must be completed during the annual hospital TB skin testing program. All employees are required to report any positive sign and symptoms of TB at any time during the year to Employee Health Services.

5. Any employee with a past positive TB test and answering yes to any sign or symptom of TB reported on the survey, unexplained by other medical conditions, will require a chest x-ray. These employees x-rays will be reviewed by the Hospital Epidemiologist. If cleared from active TB disease, the employee may be advised to seek further medical evaluation from their primary physician. These cases will be reviewed with the Employee Health Physician and the Employee Health Nurse on an individual basis. The employee will be advised of the course of action to be taken if outside of the following treatment plan.

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i. a positive or questionable chest x-ray, and positive sign and symptom review will be sent to the

SNHD for clearance. They will not be allowed to return to work until clearance is obtained. ii. A negative chest x-ray and a positive sign and symptom review will be evaluated by the physician.

After evaluation, the physician will determine if an employee may return to or begin work.

6. Quantiferon testing at UMC is done on a case by case basis after consultation with the hospital epidemiologist. Quantiferon testing from other hospitals are accepted as an annual test, if the test is performed within the acceptable time frame, as noted under initial TB testing.

7. All full time and part time employees must complete TB screening during the annual TB testing period. New hires must have their TB screen repeated during the annual TB testing period. Per-diem employees may turn in a completed TB test from another place of employment. TB Tests from other places of employment must meet all state requirements. i. Failure to complete the required TB screen prior to expiration shall result in the employee

being suspended at the end of the calendar month and continuing until the TB screening is completed.

ii. If the employee fails to complete TB testing within thirty (30) calendar days of its expiration, he/she shall be suspended pending termination

8. All full time and part time employees must complete TB screening during the annual TB testing period. New hires must have their TB screen repeated during the annual TB testing period. i. Failure to complete the required TB screen prior to expiration shall result in the employee

being suspended at the end of the calendar month of the annual TB screening and continuing until the TB screening is completed.

ii. If the employee fails to complete TB testing within thirty (30) calendar days of its expiration, he/she shall be suspended pending termination.

D. Illness at Work/Return to Work

When an employee is ill at work, the manager has the authority to determine whether or not the individual should remain on the job. The manager may consult with Employee Health Services for assistance in making this decision. Upon request from either management or the employee, the Employee Health Nurse in consultation with the Medical Director of Epidemiology, will provide an evaluation and recommendation to management. (See current CBA agreement and the HR Attendance Policy VI-Procedure 9 for other return to work details)

The Human Resources Department handles all medical leave of absences and FMLA.

Worker’s Compensation Insurance for illnesses or injury arising out of, or in the course of employment under the Nevada State Workers Compensation Act is provided to all employees. Employees returning to work after more than 5 days off, must bring a return to work slip from their physician. The note must state whether they are released to full duty or if they have any work restrictions. All return to work notes go to the workers compensation office at UMC Human Resource Department (Delta Point Office). Employees with work restrictions must report to HR (Delta Point) and see the workers comp coordinator for light duty placement. This includes all return to work employees whether they are under a worker’s comp claim or not.

E. Employee’s with or Suspected of an Infectious Disease

When an employee is suspected of, has an infectious disease, or is exposed to an infectious disease that may place other staff at risk, Employee Health Services must be notified. Any employee who has an infectious disease of epidemiological importance will inform the Employee Health Nurse and their manager as soon as possible. Examples of epidemiological important infectious disease are pertussis,

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hepatitis, chickenpox, measles, mumps, influenza and tuberculosis. UMC will abide by state and CDC guidelines for tuberculosis exposures. Employee Health under the direction of the Medical Director of Epidemiology, may screen and refer the employee for proper assessment, testing, prophylaxis’s treatment and counseling as needed. If after screening, a vaccination is required, Employee Health Services may administer vaccinations according to this policy under the direction of the Medical Director of Epidemiology. All employees referred for outside treatment, will be required to submit with a return to work slip noting that they are free of infections/contagious disease. Work restrictions may be implemented for personnel with infectious diseases.

F. Employee Needle Stick or Blood/Body Fluid Exposure: For a detailed description of Employee Health responsibilities, see Blood Borne Pathogen Exposure Policy (EH 6.2).

G. Maintenance of Employee Health Records: Records are maintained in accordance with regulatory

agencies. REFERENCES

1. Nevada Administrative Code. Chapter 441A Communicable Diseases 2. Centers for Disease Control and Prevention, Guidelines for Preventing Transmission of Mycobacterium Tuberculosis in

Healthcare Settings, 2005 December 30, 2005/54(RR17);1-141 http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5417a1.htm

3. TDAP VACCINATION; Tdap Vaccination Strategies for Adolescents and Adults, Including Health Care Personnel, Copyright 2011 Joint Commission.

4. Department of Health and Human Services Center for Disease Control and Prevention, Summary Report for Advisory Committee on Immunization Practices (ACIP) October 24-25, 2012.

5. Centers for Disease Control and Prevention, CDC Guidance for Evaluating Health-Care Personnel for Hepatitis B Virus Protection and for Administering Post Exposure Management. Vol 62/No.10/December 20, 2013 http://www.cdc.gov/mmwr/preview/mmwrhtml/rr6210a1.htm?s_cid=rr6210a1_w

6. Immunizations of Health-Care Personnel; Recommendations of the Advisory Committee on Immunization Practices (ACIP), Recommendations and Reports. November 25, 2011/60(RR07);1-45. http://www.cdc.gov/mmwr/preview/mmwrhtml/rr6007a1.htm

7. Healthcare Personnel Vaccination Recommendations; www.immunize.org/catg.d/p2017pdf-Item#P2017(3/14)

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http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5417a1.htm

http://www.cdc.gov/mmwr/preview/mmwrhtml/rr6210a1.htm?s_cid=rr6210a1_w

http://www.cdc.gov/mmwr/preview/mmwrhtml/rr6007a1.htm

Attachment E Notice of False Claims and Statements

UMC’s Compliance Program demonstrates its commitment to ethical and legal business practices and ensures service of the highest level of integrity and concern. UMC’s Compliance Department provides UMC compliance oversight, education, reporting and resolution. It conducts routine, independent audits of UMC’s business practices and undertakes regular compliance efforts relating to, among other things, proper billing and coding, detection and correction of coding and billing errors, and investigation of and remedial action relating to potential noncompliance. It is our expectation that as a physician, business associate, contractor, vendor, or agent, your business practices are committed to the same ethical and legal standards. The purpose of this Notice is to educate you regarding the federal and state false claims statutes and the role of such laws in preventing and detecting fraud, waste, and abuse in federally funded health care programs. As a Medical Staff Member, Vendor, Contractor and/or Agent, you and your employees must abide by UMC’s policies insofar as they are relevant and applicable to your interaction with UMC. Additionally, providers found in violation of any regulations regarding false claims or fraudulent acts are subject to exclusion, suspension, or termination of their provider status for participation in Medicaid. Federal False Claims Act The Federal False Claims Act (the “Act”) applies to persons or entities that knowingly and willfully submits, cause to be submitted, conspire to submit a false or fraudulent claim, or use a false record or statement in support of a claim for payment to a federally-funded program. The Act applies to all claims submitted by a healthcare provider to a federally funded healthcare program, such as Medicare. Liability under the Act attaches to any person or organization who “knowingly”:

• Present a false/fraudulent claim for payment/approval; • Makes or uses a false record or statement to get a false/fraudulent claim paid or approved by the government; • Conspires to defraud the government by getting a false/fraudulent claim paid/allowed; • Provides less property or equipment than claimed; or • Makes or uses a false record to conceal/decrease an obligation to pay/provide money/property.

“Knowingly” means a person has: 1) actual knowledge the information is false; 2) acts in deliberate ignorance of the truth or falsity of the information; or 3) acts in reckless disregard of the truth or falsity of the information. No proof of intent to defraud is required. A “claim” includes any request/demand (whether or not under a contract), for money/property if the US Government provides/reimburses any portion of the money/property being requested or demanded. For knowing violations, civil penalties range from $5,500 to $11,000 in fines, per claim, plus three times the value of the claim and the costs of any civil action brought. If a provider unknowingly accepts payment in excess of the amount entitled to, the provider must repay the excess amount. Criminal penalties are imprisonment for a maximum 5 years; a maximum fine of $25,000; or both. Nevada State False Claims Act Nevada has a state version of the False Claims Act that mirrors many of the federal provisions. A person is liable under state law, if they, with or without specific intent to defraud, “knowingly:”

• presents or causes to be presented a false claim for payment or approval; • makes or uses, or causes to be made or used, a false record/statement to obtain payment/approval of a false

claim; • conspires to defraud by obtaining allowance or payment of a false claim;

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• has possession, custody or control of public property or money and knowingly delivers or causes to be delivered to the State or a political subdivision less money or property than the amount for which he receives a receipt;

• is authorized to prepare or deliver a receipt for money/property to be used by the State/political subdivision and knowingly prepares or delivers a receipt that falsely represents the money/property;

• buys or receives as security for an obligation, public property from a person who is not authorized to sell or pledge the property; or

• makes, uses, or causes to be made or used, a false record or statement to conceal, avoid, or decrease an obligation to pay or transmit money or property to the state/political subdivision.

Under state law, a person may also be liable if they are a beneficiary of an inadvertent submission of a false claim to the state, subsequently discovers that the claim is false, and fails to disclose the false claim to the state within a reasonable time after discovery of the false claim. Civil penalties range from $5,000 to $10,000 for each act, plus three times the amount of damages sustained by the State/political subdivision and the costs of a civil action brought to recover those damages. Criminal penalties where the value of the false claim(s) is less than $250, are 6 months to1 year imprisonment in the county jail; a maximum fine of $1,000 to $2,000; or both. If the value of the false claim(s) is greater that $250, the penalty is imprisonment in the state prison from 1 to 4 years and a maximum fine of$5,000. Non-Retaliation/Whistleblower Protections Both the federal and state false claims statutes protect employees from retaliation or discrimination in the terms and conditions of their employment based on lawful acts done in furtherance of an action under the Act. UMC policy strictly prohibits retaliation, in any form, against any person making a report, complaint, inquiry, or participating in an investigation in good faith. An employer is prohibited from discharging, demoting, suspending, harassing, threatening, or otherwise discriminating against an employee for reporting on a false claim or statement or for providing testimony or evidence in a civil action pertaining to a false claim or statement. Any employer found in violation of these protections will be liable to the employee for all relief necessary to correct the wrong, including, if needed,:

• reinstatement with the same seniority; or • damages in lieu of reinstatement, if appropriate; and • two times the lost compensation, plus interest; and • any special damage sustained; and • punitive damages, if appropriate.

Reporting Concerns Regarding Fraud, Abuse and False Claims Anyone who suspects a violation of federal or state false claims provisions is required notify UMC via a hospital Administrator, department Director, department Manager, or Rani Gill, the Corporate Compliance Officer, directly at (702) 383-6211. Suspected violations may also be reported anonymously via the Hotline at (888) 691-0772 or http://umcsn.silentwhistle.com. The Hotline is available 24 hours a day, seven days a week. Compliance concerns may also be submitted via email to the Compliance Officer at [email protected]. Upon notification, the Compliance Officer will initiate a false claims investigation. A false claims investigation is an inquiry conducted for the purpose of determining whether a person is, or has been, engaged in any violation of a false claim law. Retaliation for reporting, in good faith, actual or potential violations or problems, or for cooperating in an investigation is expressly prohibited by UMC policy.

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http://umcsn.silentwhistle.com/


Attachment F Insurance Requirements

TO ENSURE COMPLIANCE WITH THE AGREEMENT DOCUMENT, PROVIDER SHOULD FORWARD THE FOLLOWING INSURANCE CLAUSE AND SAMPLE INSURANCE FORM TO THEIR INSURANCE AGENT PRIOR TO PROPOSAL SUBMITTAL.

A. Format/Time: The PROVIDER shall provide HOSPITAL with Certificates of Insurance, per the sample format (page B-3), for coverage as listed below, and endorsements affecting coverage required by this Agreement within ten (10) business days after the award by the HOSPITAL. All policy certificates and endorsements shall be signed by a person authorized by that insurer and who is licensed by the State of Nevada in accordance with NRS 680A.300. All required aggregate limits shall be disclosed and amounts entered on the Certificate of Insurance, and shall be maintained for the duration of the Agreement and any renewal periods.

B. Best Key Rating: The HOSPITAL requires insurance carriers to maintain during the Agreement term, a Best Key Rating of A.VII or higher, which shall be fully disclosed and entered on the Certificate of Insurance.

C. HOSPITAL Coverage: The HOSPITAL, its officers and employees must be expressly covered as additional insured’s except on Workers' Compensation. The PROVIDER’s insurance shall be primary as respects the HOSPITAL, its officers and employees.

D. Endorsement/Cancellation: The PROVIDER’s general liability and automobile liability insurance policy shall be endorsed to recognize specifically the PROVIDER’s contractual obligation of additional insured to HOSPITAL and must note that the HOSPITAL will be given thirty (30) calendar days advance notice by certified mail “return receipt requested” of any policy changes, cancellations, or any erosion of insurance limits. Either a copy of the additional insured endorsement, or a copy of the policy language that gives HOSPITAL automatic additional insured status must be attached to any certificate of insurance.

E. Deductibles: All deductibles and self-insured retentions shall be fully disclosed in the Certificates of Insurance and may not exceed $25,000.

F. Aggregate Limits: If aggregate limits are imposed on bodily injury and property damage, then the amount of such limits must not be less than $2,000,000.

G. Commercial General Liability: Subject to Paragraph 6 of this Exhibit, the PROVIDER shall maintain limits of no less than $1,000,000 combined single limit per occurrence for bodily injury (including death), personal injury and property damages. Commercial general liability coverage shall be on a “per occurrence” basis only, not “claims made,” and be provided either on a Commercial General Liability or a Broad Form Comprehensive General Liability (including a Broad Form CGL endorsement) insurance form. Policies must contain a primary and non-contributory clause and must contain a waiver of subrogation endorsement.

H. Automobile Liability: Subject to Paragraph 6 of this Exhibit, the PROVIDER shall maintain limits of no less than $1,000,000 combined single limit per occurrence for bodily injury and property damage to include, but not be limited to, coverage against all insurance claims for injuries to persons or damages to property which may arise from services rendered by PROVIDER and any auto used for the performance of services under this Agreement.

I. Professional Liability: The PROVIDER shall maintain limits of no less than $1,000,000 aggregate. If the professional liability insurance provided is on a Claims Made Form, then the insurance coverage required must continue for a period of two (2) years beyond the completion or termination of this Agreement. Any retroactive date must coincide with or predate the beginning of this and may not be advanced without the consent of the HOSPITAL.

J. Workers' Compensation: The PROVIDER shall obtain and maintain for the duration of this Agreement, a work certificate and/or a certificate issued by an insurer qualified to underwrite workers’ compensation insurance in the State of Nevada, in accordance with Nevada Revised Statutes Chapters 616A-616D.

K. Failure To Maintain Coverage: If the PROVIDER fails to maintain any of the insurance coverage required herein, HOSPITAL may withhold payment, order the PROVIDER to stop the work, declare the PROVIDER in breach, suspend or terminate the Agreement, assess liquidated damages as defined herein, or may purchase replacement insurance or pay premiums due on existing policies. HOSPITAL may collect any replacement insurance costs or premium payments made from the PROVIDER or deduct the amount paid from any sums due the PROVIDER under this Agreement.

L. Additional Insurance: The PROVIDER is encouraged to purchase any such additional insurance as it deems necessary.

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M. Damages: The PROVIDER is required to remedy all injuries to persons and damage or loss to any property of HOSPITAL, caused in whole or in part by the PROVIDER, their subcontractors or anyone employed, directed or supervised by PROVIDER.

N. Cost: The PROVIDER shall pay all associated costs for the specified insurance. The cost shall be included in the price(s).

O. Insurance Submittal Address: All Insurance Certificates requested shall be sent to University Medical Center, Attention: Contracts Management. See the Submittal Requirements Clause in the Agreement for the appropriate mailing address.

P. Insurance Form Instructions: The following information must be filled in by the PROVIDER’s Insurance Company representative:

1) Insurance Broker’s name, complete address, phone and fax numbers.

2) PROVIDER’s name, complete address, phone and fax numbers.

3) Insurance Company’s Best Key Rating

4) Commercial General Liability (Per Occurrence) (A) Policy Number (B) Policy Effective Date (C) Policy Expiration Date (D) Each Occurrence ($1,000,000) (E) Damage to Rented Premises ($50,000) (F) Medical Expenses ($5,000) (G) Personal & Advertising Injury ($1,000,000) (H) General Aggregate ($2,000,000) (I) Products - Completed Operations Aggregate ($2,000,000)

5) Automobile Liability (Any Auto) (J) Policy Number (K) Policy Effective Date (L) Policy Expiration Date (M) Combined Single Limit ($1,000,000)

6) Worker’s Compensation

7) Professional Liability (N) Policy Number (O) Policy Effective Date (P) Policy Expiration Date (Q) Aggregate ($1,000,000)

8) Description: CBE Number and Name of Agreement (must be identified on the initial insurance form and each renewal form).

9) Certificate Holder:

University Medical Center of Southern Nevada c/o Contracts Management 1800 W. Charleston Blvd. Las Vegas, Nevada 89102

10) Appointed Agent Signature to include license number and issuing state.

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12/16/2015

9887868

168204

Hanger, Inc.

& all its wholly owned subsidiaries

10910 Domain Drive # 300Austin, TX 78758

10910 Domain Drive # 300

Austin, TX 78758

Hanger, Inc. & all its wholly owned subsidiaries

Federal Insurance Company

Travelers Indemnity Co of AmericaACE Property and Casualty Ins. Co.

Travelers Indemnity Company

Travelers Property Casualty Co of America

Chubb Custom Insurance Company

20281

25666

20699

25658

2567438989

5151 Belt Line Road, Suite 200

Dallas, TX 75254

Commercial Lines – (972) 588-6456

Wells Fargo Insurance Services USA, Inc.

Megan Bruce

972-341-8826 855-605-8264

[email protected]

1,000,000

2,000,000

X 1,000,00001/01/2016 01/01/20171,000,000

A

SIR $500,000

X

X

35948279

X

BX

H8108A48737ATIA16 01/01/2016 01/01/2017 1,000,000

5,000,000

01/01/2016 01/01/2017C 5,000,000X G27836550

X 10,000

X

1,000,000

1,000,000

D

E

E

TRKUB823K602816 MA/AZ/

1,000,000

01/01/2016

TC2JUB823K600416 all other 01/01/2016 01/01/2017

Incl OH Stop Gap 01/01/2016 01/01/2017

01/01/2017 X

N

F Misc Med ProfProfessionalRetro Date 01/01/04 and vrs

01/01/201601/01/2016 01/01/201779957348SIR Applies per policyterms and conditions

$10,000,000 each wrongful act$10,000,000 aggregate, policy limitClaims Made

Master Certificate - Evidence of Insurance.

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CID: 168204 SID: 9887868

OTHER Coverage

INSRLTR

TYPE OF INSURANCE ADDLINSR

WVDSUBR

POLICY NUMBER EFFECTIVE DATE(MM/DD/YY)

EXPIRATION DATE(MM/DD/YY)

LIMIT

A Products/Completed 99486423 01/01/2016 01/01/2017 $10,000,000 each occurrence

Operations Liability SIR $500,000 $10,000,000 aggregate

Retro Date 01/01/04 Claims Made

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SpecialtyCare One American Center, 3100 West End Avenue, Suite 800, Nashville, TN 37203 • 615-345-5400

www.specialtycare.net 1619-IM-CO0105-F03-FINAL [122315]

1

Agreement for Intraoperative Neuromonitoring Services

This Agreement for Intraoperative Neuromonitoring Services (“Agreement”) is by and among SpecialtyCare IOM Services, LLC (“SpecialtyCare”), and University Medical Center of Southern Nevada, a publicly owned and operated hospital created by virtue of Chapter 450 of the Nevada Revised Statutes (“Client”). Any notices or other communications required or permitted to be given pursuant to this Agreement shall be sent to the parties at the addresses set forth on the signature page to this Agreement.

1. Engagement of SpecialtyCare. Client hereby retains SpecialtyCare to be a dual source provider of the services set forth on Exhibit A, attached and incorporated into this Agreement for all purposes, which shall include providing the services supplies (“Supplies”), instruments and equipment (“Equipment”) (collectively, the “Services”); and SpecialtyCare shall receive the Compensation (so called in this Agreement) for those Services, as set forth on Exhibit A.

2. Term. This Agreement shall be effective as of ______________________ (the “Effective Date”) and shall remain in effect for a period of sixty (60) months, unless earlier terminated as provided in this Agreement.

3. Payment. Client shall pay SpecialtyCare the compensation on or before the 30th day immediately following the date of the invoice. Client payments pursuant to this Agreement will be made by wire transfer, approved credit card, or check mailed to SpecialtyCare’s lock box; provided, however, if Client elects to pay by wire transfer or approved credit card, Client shall pay any related fees or charges set by SpecialtyCare.

4. SpecialtyCare Responsibilities. Subject to the terms of the Agreement, SpecialtyCare shall:

a) Provide the Services pursuant to a physician’s order or otherwise as requested by Client in a professional and timely manner consistent with applicable federal, state and local laws, regulations and ordinances (“Laws”) and other applicable standards and requirements, including the standards of The Joint Commission or other relevant accrediting agencies (“Standards”). SpecialtyCare is The Joint Commission certified, as set forth on Exhibit B, attached and incorporated into this Agreement;

b) Where applicable, perform data aggregation services, including comparative analyses, and report to Client quality information or data on a confidential basis, including opportunities for improvement.

5. Client Responsibilities. Client shall:

a) Cooperate with SpecialtyCare to develop and implement a process for scheduling delivery of the Services, coordinating call coverage, and managing response times;

b) Retain full responsibility and authority to (i) diagnose or treat patients including directing SpecialtyCare employees (“Staff”) providing Services under the supervision of physicians or Client personnel and (ii) implement and enforce Client’s policies and procedures;

c) Provide the following to the Staff (at Client’s expense, unless noted otherwise below): (i) authorized access to Client’s clinical and patient records, including electronic records; (ii) except as specifically set forth in the Agreement, all syringes, needles, fluids, surgical instruments, protective wear, scrubs, radiation dosimetry badges, and miscellaneous items used in the administration of Services; (iii) at SpecialtyCare’s expense, any health screening, vaccinations, and cardiopulmonary resuscitation training and certification required by Client for Staff; (iv) lockable space, to store Instruments, Supplies and Equipment used in the provision of Services, as applicable; (v) access to a reliable high speed internet connection; and (vi) parking shall be made available to the Staff on the same basis as Client provides such items to its similarly-situated employees.

6. Approvals and Credentialing. Client understands that Staff’s ability to perform Services is directly preconditioned

upon the Client timely granting the required credentials, clinical privileges and other approvals (“Approvals”) required by

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2

Client for Staff to provide Services. To that end, Client agrees that Staff shall be deemed approved upon the expiration of 60 days following such Staff’s submission of all materials required by Client for credentialing, unless Client notifies SpecialtyCare that such Staff is not approved. In addition, Client agrees to grant timely emergency Approvals within 48 hours of SpecialtyCare’s request for replacement Staff, such Approvals to be effective until such time as a permanent replacement Staff receives the required Approvals.

7. Restrictive Covenants. Client agrees that, as a result of the Services provided by SpecialtyCare hereunder, Client will have material contact with certain employees or independent contractors of SpecialtyCare and its affiliates, including members of the Staff (each, a “Protected Employee”), who possess proprietary information and trade secrets belonging to SpecialtyCare. Accordingly, during the term of this Agreement and for a period of twelve (12) months following the termination or expiration of this Agreement for any reason, Client shall not, without the prior written consent of SpecialtyCare, directly or indirectly receive or purchase Services from a Protected Employee, or hire, engage or otherwise solicit or induce, or attempt to solicit or induce, any Protected Employee to terminate his or her employment or engagement with SpecialtyCare or to enter into an employment or contractor relationship with Client.

8. Consignment. If, pursuant to the Agreement, SpecialtyCare maintains inventory of Instruments and Supplies for sale to Client on a consignment basis, SpecialtyCare will be responsible for the inventory control and management thereof. At all times, SpecialtyCare shall have and retain all right, title and interest in such Instruments and Supplies until such time as they are sold to Client. In the event that Client or its employees, agents or other service contractors use any consigned Instruments and Supplies without the consent of SpecialtyCare, Client shall pay SpecialtyCare for such Instruments and Supplies in accordance with the fee schedule or schedules set forth in Exhibit A. Fees are incurred as Supplies are used, unpackaged, applied, or otherwise compromised in preparing for or providing Services. Furthermore, Client agrees to reimburse SpecialtyCare for Client requested special order supplies or Client required inventory supplies that expire due to non-utilization.

9. Direct Purchases. Instruments and Supplies provided on a direct basis “Direct”, will be ordered by Client and purchased directly from SpecialtyCare (each a “Direct Purchase”) on a non-exclusive basis, with orders subject to acknowledgement and acceptance by SpecialtyCare and payment of freight charges by Client. SpecialtyCare will not provide inventory control or management for Direct Purchases.

10. Disposable Supplies. Except as otherwise specifically provided in Exhibit A, the selection of the manufacturer(s) and model(s) for disposable supplies shall be solely within SpecialtyCare’s discretion. In the event the fee(s) for any of the disposable supplies, including any applicable discount, falls outside of the range of fair market value, SpecialtyCare shall notify Client in writing, and unless Client advises SpecialtyCare such change is not approved within thirty (30) days of such notice, manufacturer’s list price shall apply to the affected fee(s).

11. SpecialtyCare Equipment. SpecialtyCare shall provide such Equipment that SpecialtyCare, in consultation with Client, determines is appropriate for SpecialtyCare’s use in providing the Services. SpecialtyCare shall retain all right, title, and interest in such Equipment notwithstanding that any Equipment or any part thereof may be in any manner affixed or otherwise connected to any property or premises belonging to or under the control of Client or any other person or entity. Such Equipment shall be for SpecialtyCare’s exclusive use and shall not be used by Client or its employees, agents or other contractors without SpecialtyCare’s prior consent. To the extent such Equipment remains on the Client’s premises, SpecialtyCare shall have the right to enter the premises where the Equipment is temporarily located for the purpose of inspecting, using, servicing, removing and replacing the Equipment.

12. Client Equipment. Except as otherwise specifically provided in Exhibit A, Client shall, at its expense, perform preventive maintenance, service, repairs and calibration on all Client-owned equipment. Client shall provide SpecialtyCare with documentation of such preventive maintenance, repairs or calibration or other information relevant to or affecting the operation and performance of Client-owned equipment.

13. Disclaimer of Warranties. All Instruments, Supplies and Equipment are sold and/or provided AS

IS, and SpecialtyCare disclaims all express and implied warranties, including without limitation, fitness for a particular use, merchantability, title, and those with respect to proprietary or intellectual property rights.

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14. Termination. This Agreement may be terminated at any time by either party providing 30-day written

notice to the other party, or in the event of the following:

a) Default. If either party materially defaults in the performance of its obligations hereunder and fails to cure such default, or implement a plan to cure such default that is reasonably acceptable to the non-defaulting party, within twenty (20) days immediately following receipt of written notice from the non-defaulting party specifying the default in reasonable detail;

b) Immediate Termination. Upon delivery of written notice by either party in the event of the

occurrence of any of the following events: (i) The cessation by either party of the operations requiring or providing the Services; (ii) either party’s loss of permits or other authorizations required for the provision Services; (iii) any Exclusion/Adverse Action relating to the other party; or (iv) either party enters into or files (or has filed or commenced against it, unless dismissed within sixty (60) days) a petition, arrangement, application, action or other proceeding seeking relief or protection under the bankruptcy or similar laws of the United States dissolves, or transfers all or substantially all of its assets to another person or entity in an effort to avoid its obligations to creditors; or

c) Change in Laws or Standards. In the event of a change in existing Laws or Standards that

materially and adversely affects either party’s ability to comply with such Laws or Standards or to perform any material term of this Agreement then the parties shall engage in good faith negotiations to amend this Agreement to comply with such Laws or Standards; provided, however, that the amendment needed to comply with such Laws or Standards does not materially change either party’s rights or responsibilities. If the parties are unable to resolve the matter within thirty (30) days, either party may terminate this Agreement.

15. Effect of Termination. SpecialtyCare shall have no obligation to provide Services after the effective date

of the termination of the Agreement. Termination of this Agreement shall not relieve Client of the obligation to timely pay all sums due and owing for Services ordered or provided prior to the effective date of termination. In the event of termination or expiration of this Agreement at the request or fault of Client, Client shall purchase from SpecialtyCare any custom Supplies requested by Client during the term of this Agreement at the prices in effect for such Supplies prior to such discontinuation or termination.

16. Independent Contractor Relationship. SpecialtyCare is an independent contractor to Client. This Agreement does not create any agency, employment, or joint venture relationship between the parties, nor shall this Agreement create a right of either party to control the method and/or manner of work by the other party; or, obligate the other party. Each party is liable for its own debts, obligations, acts and omissions, including the payment of all required withholding, Social Security and other taxes or benefits on behalf of its employees, agents and contractors.

17. Performance Assessments. The designated management teams of the parties will meet as mutually agreed to conduct performance assessments and to discuss performance of their respective obligations under the Agreement, opportunities for improvement, and quality of Services provided under the Agreement.

18. Representations and Covenants Related to Compliance with Standards and Laws.

a) Compliance. Each party represents that it is in compliance, and agrees that it will remain in compliance during the term of the Agreement, with those Laws and Standards relating to the operation of its businesses and the performance of its obligations pursuant to the Agreement, including the requirements of third-party payors (including governmental payors). The parties intend to comply with all applicable federal or state law provisions governing fraud and abuse and/or self-referrals under governmental healthcare programs, as such provisions may be amended from time to time (collectively, “Fraud and Abuse Laws”). The parties further intend that this Agreement comply with the following under any applicable Fraud and Abuse Law: (i) as many as reasonably practicable of the conditions for meeting, as applicable, the personal services and management contract safe harbor, (ii) the discount safe harbor, and (ii) any other applicable safe harbors or exceptions under any applicable Fraud and Abuse Law. Client shall be solely responsible for complying with its respective obligations under the discount safe harbor, including determining whether any savings or discounts it receives from SpecialtyCare must be reported and passed on to any federal health care program as defined in 42 U.S.C. § 1320a – 7b(f) (the “Federal Health Care Programs”). The Compensation is intended to be at fair market value. In the event of market or other changes or events that may affect payment to SpecialtyCare of Compensation at fair market value, SpecialtyCare may give notice to Client of the need for an amendment, and within sixty (60) days of such notice, the parties

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shall negotiate in good faith to amend the Agreement to reflect an adjustment to pricing to address such change. If the parties are unable to reach an agreement within sixty (60) days, either party may terminate this Agreement.

b) No Exclusion. Each party represents that it (i) is not currently excluded, debarred or otherwise

declared to be ineligible to participate in any Federal Health Care Programs and (ii) has not been convicted of a criminal offense related to the provision of health care items or services but not yet excluded, debarred, or otherwise declared ineligible to participate in the Federal Healthcare Programs (collectively “Exclusions/Adverse Actions”). SpecialtyCare will screen its Staff against the U.S. Department of Health and Human Services/Office of Inspector General List of Excluded Individuals/Entities (available at http://www.oig.hhs.gov) and the U.S. General Services Administration List of Parties Excluded from the Federal Health Care Programs (available at http://www.epls.gov). If any Staff fails to satisfy the exclusions criteria set forth in this Section such individual will not provide Services under this Agreement.

c) HIPAA Compliance. The parties acknowledge that they have certain obligations under the

Health Insurance Portability and Accountability Act of 1996, as amended (“HIPAA”), including without limitation the HIPAA Privacy and Security Rules promulgated at 45 C.F.R. Parts 160 and 164, and agree to comply therewith. The parties have agreed to enter into any further agreements necessary to facilitate compliance with HIPAA, including, as required, a Business Associate Agreement.

d) Access to Books and Records. In accordance with 42 C.F.R. § 420.302, upon the written request

of the Secretary of the Department of Health and Human Services or the Comptroller General or any of their duly authorized representatives, SpecialtyCare will make available those contracts, books, documents and records necessary to verify the nature and extent of the costs of providing Services under this Agreement. Such inspection shall be available up to four (4) years after the rendering of such Services. If SpecialtyCare carries out any of the duties of this Agreement through a subcontract with a value of $10,000 or more over a twelve (12) month period with a related individual or organization, SpecialtyCare agrees to include this requirement in any such subcontract.

19. Confidentiality. To the extent permissible by federal, local or state law, rule or regulation, the parties

hereto shall hold in confidence the information contained in this Agreement during the term of this Agreement, and for a period of two (2) years after termination, and each of them hereby acknowledges and agrees that all information related to this Agreement, not otherwise known to the public, is confidential and proprietary and is not to be disclosed to third persons without the prior written consent of each of the parties except (i) to the extent necessary to comply with any law, rule or regulation, or the valid order of any governmental agency or any court of competent jurisdiction; (ii) to its auditors and its attorneys as part of its normal reporting or review procedure; (iii) to its insurance agent to the extent necessary to obtain appropriate insurance; (iv) or as necessary to enforce its rights and perform its agreements and obligations under this Agreement. Additionally, SpecialtyCare acknowledges that Client is a public, county-owned hospital which is subject to the provisions of the Nevada Public Records Act, Nevada Revised Statutes Chapter 239, as may be amended from time to time. As such, its contracts are public documents available for copying and inspection by the public. If Client receives a demand for the disclosure of any information related to this Agreement that SpecialtyCare has claimed to be confidential and proprietary, Client will immediately notify SpecialtyCare of such demand and SpecialtyCare shall immediately notify Client of its intention to seek injunctive relief in a Nevada court for protective order. SpecialtyCare shall indemnify and defend Client from any claims or actions, including all associated costs and attorney’s fees, demanding disclosure of SpecialtyCare document(s) in Client’s custody and control that SpecialtyCare claims to be confidential and proprietary, as long as Client has properly notified SpecialtyCare of such demand. The parties acknowledge and agree, for data analyses purposes, SpecialtyCare has ownership and rights to any patient data it collects during the provision of Services.

20. Insurance. SpecialtyCare shall maintain, at its own expense, worker’s compensation with statutory limits, commercial, general and professional liability insurance or self-insurance for bodily injury, death and property loss and damage (including coverage for product liability, completed operations, contract liability and personal injury liability) for claims, lawsuits or damages arising out of its performance under this Agreement or the negligent or otherwise wrongful acts or omissions by such party or any of its employees or agents. With the exception of worker’s compensation insurance, all such policies of insurance shall provide minimum limits of liability in the amount of one million dollars ($1,000,000) per claim and three million dollars ($3,000,000) annual aggregate. If such coverage is provided on a claims-made basis, such insurance shall continue through the later of the expiration or cancellation of such policy or the termination, expiration or completion of this Agreement and upon the termination, expiration or completion thereof, or the expiration or cancellation of the insurance, such party shall purchase or arrange for the purchase of either an unlimited reporting endorsement “Tail Coverage” or “Prior Acts” coverage with a retroactive date on or prior to the Effective Date of this Agreement, whichever is earlier, for a period of not less than five (5) years following the termination, expiration or

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completion thereof. Upon request of Client, a certificate of insurance evidencing the existence of all coverage required hereunder shall be provided by SpecialtyCare.

Client is owned and operated by Clark County, a political subdivision of the State of Nevada, pursuant to the provisions of Chapter 450 of the Nevada Revised Statutes. As such, Clark County and Client are protected by the limited waiver of sovereign immunity contained in Chapter 41 of the Nevada Revised Statutes. Client is self-insured as allowed by Chapter 41 of the Nevada Revised Statutes. Upon request, Client will provide SpecialtyCare with a Certificate of Coverage prepared by its Risk Management Department certifying such self coverage.

21. Indemnification. To the extent expressly authorized by Nevada law, each party shall indemnify, defend, and hold the other party harmless from and against any and all losses, claims, suits, damages, liabilities and expenses (including, without limitation, reasonable attorneys’ fees) asserted, demanded or filed by a third party against a party seeking indemnification under the section of any nature or kind whatsoever arising out of or resulting from, directly or indirectly: (a) a party’s breach of this Agreement, including, without limitation, breach of any representation, warranty, or covenant of such party in this Agreement; and (b) any alleged negligent or intentional acts or omissions of a party, its agents or employees, based upon, arising out of or attributable to the performance or non-performance of their respective obligations under this Agreement. Upon notice, the other party shall resist and defend, at its own expense, any such claim or action. Said indemnity is in addition to any other rights the indemnified party may have against the indemnifying party. This Section shall survive the expiration or termination of this Agreement.

22. Limitation of Liability. The parties acknowledge and agree that SpecialtyCare’s liability to Client shall not exceed the fees paid by Client to SpecialtyCare for the Services; and the liability of SpecialtyCare for claims by Client for indemnification against third parties under Section 21 above, shall not exceed SpecialtyCare’s insurance liability limit per claim set out in Section 20 above. Notwithstanding any other provision in the Agreement, in no event shall either party be liable for any special, indirect, incidental, punitive or consequential damages, including but not limited to, loss of use, lost profits or revenue, or cost of substitutes.

23. Quality Measurement and Reporting. In support of Client’s performance improvement/quality assurance

program and Client’s efforts to comply with applicable standards of The Joint Commission and Centers for Medicare and Medicaid Services (CMS) Conditions of Participation and State and Local Regulations, SpecialtyCare agrees to collaborate with Client on quality aspects of patient care and safety. Nothing herein shall be construed as a warranty or an expectation that SpecialtyCare’s performance shall meet any particular goal or standard with respect to any quality indicator, and failure to achieve a goal or standard shall not constitute a breach of this Agreement.

24. Miscellaneous.

a) No Third Party Beneficiaries; Counterparts; Electronic Signatures. This Agreement is entered

into for the sole benefit of the parties hereto and shall not be construed as conferring any third party beneficiary status on any person or entity not a party to this Agreement. Signatures transmitted by facsimile, email or other electronic means shall be acceptable as originals. This Agreement may be executed in more than one counterpart.

b) Assignment. This Agreement may not be assigned by either party without the written consent of

the other party; provided, however, that SpecialtyCare may assign this Agreement to its affiliate. Subject to the foregoing, this Agreement shall inure to the benefit of, and be binding upon, the parties and their respective successors and assigns.

c) Force Majeure. Neither party shall incur any liability hereunder if the performance of its

obligations is prevented by acts of God, a public enemy, earthquakes, hurricanes, fires, floods, epidemics, civil insurrections, curtailment of, or failure to obtain, sufficient electrical power, strikes, or lockouts.

d) Remedies. Client acknowledges that the terms of Section 7 and Section 19 are material to

SpecialtyCare and a significant part of the Agreement and that a breach by Client of such terms would cause SpecialtyCare immediate, significant and irreparable harm for which compensatory damages will not be a sufficient remedy. In the event of any breach or threatened breach by Client of such provisions, SpecialtyCare shall have the right to injunctive relief, without the requirement of posting bond or other security, as well as any other remedy available at law or equity.

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e) Entire Agreement; Waivers; Severability; Headings. This Agreement (including exhibits and schedules), constitutes the entire Agreement between the parties with respect to the subject matter hereof, supersedes all prior representations, agreements, negotiations and understandings, and may not be amended except in writing signed by both parties. The Agreement is the product of negotiation and is not to be construed as having been drafted by either party. Any act by either party that may amount to a waiver of the conditions of this Agreement must be in writing signed by the waiving party and shall in no way constitute a future-continuing waiver of such conduct. If any term, covenant, condition, or provision of this Agreement is held by a court of competent jurisdiction or other governmental body to be invalid, void, or unenforceable, either in whole or in part, the provision(s) shall be deemed amended to delete or modify, as necessary, the offending provision(s) and to alter the remaining provision(s) to render the same enforceable to the fullest extent permissible, and the remainder of the provision(s) of the Agreement shall remain in full force and effect. All captions and headings are solely for convenience of reference and are not intended to define or limit the scope of any provisions of this Agreement.

f) Choice of Law. The rights, duties, obligations and claims arising from or associated with the

Agreement shall be construed and enforced in accordance with the laws of the State of Nevada without regard to any conflicts of law principles.

25. Budget Act and Fiscal Fund Out. In accordance with Nevada Revised Statute 354.626, the financial

obligations under this Agreement between the parties shall not exceed those monies appropriated and approved by Client for the then-current fiscal year under the Local Government Budget Act. This Agreement shall terminate, and Client’s obligations under it shall be extinguished at the end of any of Client’s fiscal years in which Client’s governing body fails to appropriate monies for the ensuing fiscal year sufficient for the payment of all amounts which could then become due under this Agreement. Client agrees that this section shall not be utilized as a subterfuge or in a discriminatory fashion as it relates to this Agreement. In the event this section is invoked, this Agreement will expire on the 30th day of June of the then-current fiscal year. Termination under this section shall not relieve Client of its existing obligations incurred through the 30th day of June of the fiscal year for which the monies were appropriated.

26. Survival. Sections 7, 8, 13, 14, 15, 16, 18(d), 19, 21, 22, 24 and 25 shall survive the termination,

expiration, or cancellation of this Agreement, for all purposes.

[SIGNATURE PAGE FOLLOWS]

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IN WITNESS WHEREOF, for good and valuable consideration and intending to be legally bound, the parties have caused this Agreement to be executed by their duly authorized officers or delegates as of the date set forth above.

SPECIALTYCARE PARENT:

CLIENT: SpecialtyCare IOM Services, LLC Signature

By: Jonathan Walters Title: President, IONM Services


Signature

By:Mason VanHouweling Title:CEO

Address for Notices: One American Center 3100 West End Avenue, Suite 800 Nashville, Tennessee 37203 Attention: General Counsel

Facsimile: 615-345-5415

Address for Notices: University Medical Center of Southern Nevada 1800 West Charleston Blvd. Las Vegas, Nevada 89102 Attn: CEO

Facsimile:702-383-2609

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EXHIBIT A

Services and Compensation

Services: Intraoperative Neuromonitoring (“IONM”)

1. Clinical Requirements.

(a) Client will provide SpecialtyCare not less than two (2) hours advance notice of unscheduled or emergency cases involving the provision of Services, and SpecialtyCare will ensure that Staff provide the Services at that time and place reasonably requested by Client.

(b) SpecialtyCare shall provide set up for Services in advance of the scheduled commencement of the surgical procedure as mutually agreed.

(c) SpecialtyCare shall be responsible for daily travel costs and costs of bringing in additional Staff and/or Equipment as may be required for certain procedures

(d) When applicable, the professional component of the Services shall be contracted for by SpecialtyCare. For remote monitoring, the professional shall be available to provide the surgeon or attending physician, as applicable, with a verbal report, followed by written authentication as required by regulatory agencies, of his or her interpretation of IONM data collected during the performance of Services in such format as may be agreed upon by the parties. As reasonably requested, SpecialtyCare agrees to use its reasonable efforts to cause the written report to be provided within twenty-four (24) hours of the completion of the procedure.

(e) The Equipment shall be placed at sites within Client’s premises as mutually agreed by Client and SpecialtyCare during the time that the Services are provided. Any such site shall have all utility, secure data transmission, and other connections, hookups, or means of attachment recommended or requested by SpecialtyCare to secure the Equipment to Client’s premises or as otherwise necessary so that the Equipment may be operated during the performance of the Services. Client shall not be required to provide lockable space for Equipment.

(f) IONM Modalities included in Services.

(i) Somatosensory Evoked Potentials (SSEP) – an intraoperative modality that stimulates the peripheral nerves in upper and lower extremities to obtain information about the sensory function of the spinal cord.

(ii) Transcranial Motor Evoked Potentials (TcMEP) – an intraoperative modality that tests the integrity of the motor tracks of the spinal cord via the use of electrical stimulation through the cranium.

(iii) Electromyography (EMG) – an intraoperative modality used to stimulate the nerve root to record compound muscle action potentials. The two (2) EMG techniques used are triggered EMG and free running EMG.

(iv) Electroencephalography (EEG) – an intraoperative modality that records brain wave activity.

(v) Facial Nerve Monitoring – the recording of two (2) to four (4) channels of free-run and triggered EMG responses during certain procedures where the facial nerve may be at risk for injury.

(vi) Brainstem Auditory Evoked Potentials – intraoperative modalities used to test the integrity of the auditory system.

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2. Billing. SpecialtyCare shall invoice Client directly for the fee per case/procedure in accordance with the Fee Schedule, and Client shall be solely responsible for billing and collecting the technical component of the Services from the appropriate payer. Where applicable and permitted, SpecialtyCare may arrange for billing to the appropriate payor directly for the professional component of the Services.

Client shall provide all patient demographics and insurance coverages of the patient to facilitate SpecialtyCare’s ability to bill for the professional component of the Services. Client will also provide operative notes on each case, much in the same way SpecialtyCare shall provide the interpretive notes back to the Client. Operative notes must be received within seven (7) days from the date Services are provided, and shall be sent electronically or faxed to an agreed upon recipient at SpecialtyCare. SpecialtyCare specifically represents that all billing related to this Agreement complies with all relevant federal, state and local laws and regulations.

Compensation:

FEE SCHEDULE

SpecialtyCare will bill Client at the following rate, with a total not-to-exceed value of $500,000 per year for the term of this Agreement. Description Fee1 1. Intra-Operative Neurophysiological Monitoring (IONM) Technical Services

includes: $595 per procedure2

• Appropriate IONM Staff • Initial Supplies as listed on Supplies Schedule in Schedule 1 • Setup and use of SpecialtyCare IONM Equipment as listed on Equipment

Schedule in Schedule 1

2. Miscellaneous Supplies Manufacturer’s List Price3

Item ID Description MLP 10004636 EMG ET Tube 6mm $ 295.00 10004637 EMG ET Tube 7mm $ 295.00 10004638 EMG ET Tube 8mm $ 295.00 10004639 Size 6 ENT Tube $ 303.00 10004575 Dragonfly 2-Chan Laryngeal Surface Elec for 6.0-7.5mm ET Tub $ 130.00 10004576 Electrode, Laryngeal Single Channel, ET Tube 7.5-10.0mm $ 105.00 10004578 Dragonfly 1-Chan Laryngeal Surface Elec for 2.0-5.5mm ET Tub $ 105.00 10005653 Endotracheal Tube, EMG 6mm $ 310.00 10005654 Endotracheal Tube, EMG 7mm $ 310.00 10005655 Endotracheal Tube, EMG 8mm $ 310.00 10007156 Nerveana RLN Monitoring Kit with 7.5mm-10.0mm Dragonfly $ 208.60 10007157 Nerveana RLN Monitoring Kit with 6.0mm-7.0mm Dragonfly $ 208.60 10006505 Dragonfly 2-Chan Laryngeal Surface Elec for 8.0-9.5mm ET Tub $ 130.00 10004571 Nasopharyngeal Electrode, Adult, Gold, 8ft Wire 2/pack $ 58.00 10004627 Finger Clip Electrode, Red/Black Twist, 24" Lead $ 34.00 10004642 Hookwire electrodes (1 set paired) $ 110.00 10006225 Electrode, 10mm Cup, MR Conditional,1.5m Lead $ 10.42

1 Fees are subject to all applicable taxes. 2 This fee will be invoiced in accordance with the billing terms set forth in this Services Agreement. 3 Manufacturer’s List Price subject to change without notice.

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SUPPLIES SCHEDULE

Description Quantity

Intra-Operative Neurophysiological Monitoring Initial Supplies include: • Subdermal needles As Needed • Surface Electrodes for SSEP stimulation As Needed • Basic Probe One (1) if Needed

EQUIPMENT SCHEDULE

Description Quantity

Intra-Operative Neurophysiological Monitoring Equipment: Portable Neurophysiology Workstation As Needed

Client shall pay all applicable sales tax and any other taxes related to or arising from the Services (including Instruments, Supplies or Equipment) purchased hereunder. Client operates as a tax-exempt entity and has provided SpecialtyCare a copy of its current Tax Exemption Certificate, and will continue to do so promptly upon any future renewal of its Tax Exemption Certificate after the Effective Date.

Other than prices identified on this Exhibit A as being priced at “Manufacturer’s List Price”, all fees and prices relating to Services shall be increased without notice on each anniversary of this Agreement using the Hospital and related services component of the U.S. Bureau of Labor Statistics’ Consumer Price Index-All Urban Consumers (Current Series) rate released two months immediately prior to the date of such increase; provided, however, that each annual increase shall not exceed three percent (3%). SpecialtyCare will provide Client at least 30-day written notice before such increases take effect.

Item ID Description MLP 10004628 1x4-Contact Platinum Strip w/Attached Cable $ 407.00 10004630 4x4 16-Contact Platinum Grid Electrode w/Attached Cable $ 765.00 10004632 1x6-Contact Platinum Strip w/Attached Cable $ 537.00 10004633 Spinal Electrode 3-Contact w/Attached Cable $ 185.00 10004634 Spinal Electrode-2 Contact $ 160.00 10004931 Multi-Stage Stimulating Clip, 1.83m Lead $ 57.00 10004712 Disposable Triple Hook Nerve Stimulator Probe $ 80.00 10004713 Disposable Double Hook Nerve Stimulator Probe $ 80.00 10004930 Natus Cortical Stim Bipolar Probe $ 355.25 10004970 Probe 2.3mm Ball Tip Suction 26cm Shaft DryTouch $ 150.00 10005187 Double Hook Probe, 2 x 2.4mm Hook 38mm x 0.75mm 1.9m Lead $ 160.00 10005188 Triple Hook Probe, 2 x 2.4mm Hook 38mm x 0.75mm 1.9m Lead $ 160.00

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www.specialtycare.net 1619-IM-CO0105-F03-FINAL [122315] Confidential

11

EXHIBIT B

Joint Commission Compliance Provisions

The Joint Commission (“TJC”) awarded SpecialtyCare a Certificate of Distinction for exceeding national consensus based industry standards in a voluntary, unannounced on-site survey, which included the successful evaluation of key processes such as credentials and competencies of its health care staff. SpecialtyCare was awarded the Certificate of Distinction as a symbol of quality for its dedication to providing safe and effective patient care, as well as its ongoing commitment to sound management practices that are consistent with the very best industry practices. SpecialtyCare remains dedicated to demonstrating continuous compliance with TJC standards applicable to the operation of its business and the Services provided. To that end, and to maintain SpecialtyCare’s certification, the Client’s accreditation, or both, the following required provisions are added to the Agreement: 1. SpecialtyCare will provide appropriate staffing for the Services through individuals who are employees or are

independent contractors of SpecialtyCare or its affiliate entity.

2. Client shall report to SpecialtyCare’s Risk Management Department any unexpected incidents, errors, and sentinel events involving SpecialtyCare Staff.

3. Client shall provide SpecialtyCare Staff with orientation to Client’s policies, procedures, rules and guidelines applicable to Services. Client shall provide a written copy of all such policies, procedures, rules and guidelines to SpecialtyCare prior to the Effective Date.

4. Client shall report to SpecialtyCare’s Human Resources Department occupational injuries, safety hazards or events involving SpecialtyCare Staff in the scope of providing Services.

5. Client shall ensure that a physician’s order or Client requisition, as applicable, is available for Services prior to the time Services are provided, that the patient or patient’s representative has provided necessary consents for Services, and that all verbal orders related to Services, whether given during the course of treatment or otherwise, are signed by the physician or other authorized health care provider.

6. Client and SpecialtyCare agree that SpecialtyCare is solely responsible for all decisions regarding the staffing for Services, including without limitation, hiring, compensation, retention, scheduling and competencies.

7. Client and SpecialtyCare agree that, as required, SpecialtyCare Staff providing Services will (i) be licensed, certified, qualified or approved to provide Services pursuant to this Agreement, (ii) receive annual clinical competency assessments commensurate with their authorized scope of practice and responsibilities in providing Services, and (iii) be assigned to provide Services in accordance with their clinical competencies.

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DISCLOSURE OF RELATIONSHIP (Suppliers)

Corporate/Business Entity Name:

(Include d.b.a., if applicable)

Street Address:

City, State and Zip Code:

Telephone No:

Point of Contact Name:

Email: 1. COMPENSATION ARRANGEMENTS - Does a UMC employee or physician who is a member of UMC’s medical staff (or does

a family member of either group) have an employment, consulting or other financial arrangement (including, without limitation, an office or space lease, royalty or licensing agreement, or sponsored research agreement) with the company?

Yes No (If yes, complete following.) Name of Person

(self or family member) Name of Company Describe the Compensation

Arrangement Dollar Value of Compensation

1.

2.

3.

(Use additional sheets as necessary) 2. BUSINESS POSITIONS - Is a UMC employee or physician who is a member of UMC’s medical staff (or does a family member

of either group) an officer, director, trustee, managing partner, officer or key employee of the company?

Yes No (If yes, complete following.) Name of Person

(self or family member) Name of Company Business

Position or Title Dollar Value of Compensation (include meeting stipends and

travel reimbursement) 1.

2.

3.

(Use additional sheets as necessary)

I certify under penalty of perjury, that all of the information provided herein is current, complete, and accurate.

Signature Print Name

Title Date

For UMC Use Only:

If any Disclosure of Relationship is noted above, please complete the following:

Yes No Is the UMC employee or physician who is a member of UMC’s medical staff (or a family member of either group) noted above involved in the contracting/selection process?

Yes No Is the UMC employee or physician who is a member of UMC’s medical staff (or a family member of either

group) noted above involved in anyway with the business in performance of the contract? Notes/Comments: ____________________________________ Signature ____________________________________ Print Name Authorized Department Representative

Revised 5/17/11 1

SpecialtyCare IOM Services, LLC

3100 West End Avenue, Suite 800Nashville, TN 37203800-348-4565

x

x

Jonathan Walters

President, IONM Services 12/9/2015

Jonathan Walters

x.5439

[email protected]

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Page 132 of 255

United States Institution/Investigator Clinical Trial Agreement

University Medical Center of Southern Nevada,

Dr. David Slattery Protocol ZS-007

CTA template_06 May 2015_revised Page 1 of 13

CLINICAL TRIAL AGREEMENT

This CLINICAL TRIAL AGREEMENT (the “Agreement”) is effective as of the date of the final

countersignature below (the “Effective Date”), by and between University Medical Center of Southern

Nevada, a publicly owned and operated hospital created by virtue of Chapter 450 of the Nevada Revised

Statutes, located at 1800 W. Charleston Blvd., Las Vegas, NV 89102 (the “Institution”), David Slattery,

MD, a privileged physician of the Institution acting within the scope of his role as Principal Investigator

(“Investigator”) and ZS Pharma, located at 508 Wrangler Drive, Suite 100, Coppell, TX 75019 (the

“Sponsor”), all of whom together are alternatively referred to as “Parties”. The Institution and the

Investigator may be collectively referred to as the “Site.”

1. STATEMENT OF WORK.

The Investigator will conduct the clinical research study entitled “Clinical Protocol ZS-007- A

Multicenter, Prospective, Observational Study to Characterize the Management of Patients with

Hyperkalemia Admitted to the Emergency Room” as may be amended from time to time (the “Protocol”),

the provisions of which are incorporated herein by reference. The Investigator shall perform the Study in

conformance with: (i) generally accepted standards of good clinical practice, (ii) the Protocol, (iii) the FDA

Form 1572, and (iv) all applicable local, state and federal laws, rules and regulations including, but not

limited to, the Federal Food, Drug and Cosmetic Act and the regulations of the FDA. The Institution shall

not reassign the conduct of the Study to another investigator without Sponsor’s express written consent. If

the Investigator is unable to perform the duties required by this Agreement, the Institution shall promptly

notify Sponsor in writing. If a mutually acceptable replacement is not available, this Agreement may be

terminated as provided herein.

The Institution shall provide appropriate resources and facilities so the Investigator can conduct the

Study in a timely and professional manner and according to the terms of this Agreement. The Site shall

ensure that only individuals who are appropriately trained and qualified will assist in conducting the Study.

The Site is responsible for ensuring that all personnel participating in the Study (“Study Site Team

Participants”) comply with the terms of this Agreement, excluding personnel supplied by Sponsor.

2. PAYMENT.

(a) ZS Pharma Inc. will pay the Institution according to the Payment Terms attached hereto as

Exhibit A (“Payment Terms”) and the Budget attached hereto as the Separate Budget Grid

(“Budget”). The Site shall exercise reasonable efforts to ensure timely receipt of pass-through

payments from Sponsor. Institution shall submit a complete and accurate IRS Form W-9 (or other

applicable IRS form) to Sponsor before any payment is made hereunder. The Parties agree that

the payment will be made to Institution as payee (“Payee”) at the payment address provided on

the IRS Form W-9. Any changes to the information on this IRS Form W-9 will require a new IRS

Form W-9, and if required by Sponsor and/or Site, a signed amendment to this Agreement. Site

represents that Institution as Payee is authorized to accept all payments on their behalf, and

Institution is obligated by separate agreement to pay Investigator. Site agrees that ZS Pharma’s

only obligation with regard to study payments is to pay Institution.

(b) The Site is an independent contractor, and the Sponsor is not responsible for any employee

benefits, pensions, workers’ compensation, withholding, or employment-related taxes as to the

Site or its personnel.

Page 133 of 255

ZS Pharma/Investigator Clinical Trial Agreement

Site: David Slattery Protocol ZS-007


(c) The Investigator and any sub-investigators will complete and sign a financial disclosure form

(FDF) when requested to do so by Sponsor. These forms shall be promptly updated as needed to

maintain their accuracy and completeness during the Study and for one year after its completion.

(d) The Site hereby agrees that no third party will be charged for any aspect of treatment or patient

care for which the Payee has invoiced or been paid under this Agreement.

(e) Unless otherwise agreed herein, payments will be made for evaluable, eligible patients only. An

eligible patient is one who meets the inclusion/exclusion requirements of the Protocol, who was

enrolled by Investigator, and from whom informed consent has been obtained. An evaluable

patient is one for whom all case report forms (“CRFs”) have been properly completed in

accordance with the Protocol, and who has completed the appropriate study procedures as set forth

in the Protocol, and undergone the evaluations required by the Protocol for assessment of efficacy

and safety.

3. RECORDKEEPING; REPORTING; ACCESS.

(a) Authorized representatives of Sponsor and/or Sponsor’s designee, have the right, upon reasonable

advance notice, and during regular business hours, to: (i) audit and examine the Site’s facilities

required for performance of the Study; and (ii) review and copy all data, records and work products

relating to the Study. The Site shall retain all records resulting from the Study for the time required

by applicable regulations, including those issued by the FDA.

(b) The Investigator will fill in electronic CRFs in accordance with Sponsor or Sponsor’s

representative’s reasonable written instructions, as the case may be. The eCRFs need to be turned

around as quickly as possible; site payments are generated based on eCRF data. The Investigator

shall be available at reasonable times during normal business hours to meet with Study monitors

and other Sponsor representatives and answer questions regarding the conduct of the Study. If

Sponsor must use or access the Site’s computer systems, it will do so in accordance with the Site’s

instructions and will only use acquired information for the purpose of the Study.

(c) The Site will promptly notify Sponsor if the FDA or any other regulatory authority notifies the

Institution or Investigator of a pending inspection relating to the Study, and will promptly forward

to Sponsor any written communication received as a result of such inspection. The Site shall,

unless prohibited by the FDA or applicable regulatory agency, allow Sponsor to participate in such

investigation or inquiry. The Site shall also provide to Sponsor copies of any documents provided

to any inspector that relate to the Study.

4. CONFIDENTIALITY.

The Protocol, CRFs, and any and all information, data, reports or documents disclosed to or

generated by the Site or any Study Site Team Participant regarding the work performed under this

Agreement or which otherwise relates to the Study (“Confidential Information”) is confidential and

proprietary information of Sponsor and shall not be disclosed by the Site or Study Site Team Participant to

any third party or be used for any purpose other than the performance of the Study without the prior written

consent of Sponsor, during a period of seven (7) years after the termination of the performance of the

Agreement, provided, however, that such obligations of confidentiality shall not apply to Confidential

Information:

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(a) that is or becomes, through no fault of the Site, part of the public knowledge;

(b) that the Site can demonstrate was already lawfully in the Site’s possession on the date of disclosure

to the Site and not subject to prior confidentiality obligations;

(c) acquired by the Site from any third party without restrictions on disclosure;

(d) that the Site developed independently of receipt of Confidential Information hereunder, as

evidenced by adequate written records; or

(e) which the Site is required by law to disclose, provided the Site promptly notifies Sponsor of such

a requirement prior to disclosure to allow Sponsor the opportunity to oppose the requirement or

seek an appropriate protective order, as described in the paragraph below.

Sponsor acknowledges that Institution is a public, county-owned hospital subject to the provisions

of the Nevada Public Records Act, Nevada Revised Statutes Chapter 239, as may be amended from time to

time. As such, its contracts are public documents available for copying and inspection by the public. If

Institution receives a demand for disclosure of any information related to this Agreement that Sponsor

claims to be confidential and proprietary, Institution will immediately notify Sponsor of such demand and

Sponsor shall immediately notify Institution of its intention to seek injunctive relief in a Nevada court for

protective order which shall be requested solely at Sponsor’s expense.

5. HIPAA.

The Parties agree that each will comply with their respective obligations as required under the

provisions of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”). Site shall take

any and all acts necessary to ensure that it will be able to provide Study data to Sponsor, including without

limitation obtaining authorization from each Study subject to provide such subject’s Protected Health

Information (as defined under HIPAA) to Sponsor and its representatives and collaborators for the purposes

of conducting the Study and conducting other research directly related to hyperkalemia, and inspecting

records and facilities related to the Study.

6. PUBLICATION.

The Study is part of a multi-site study, and publication of the results of the Study conducted at the

Site shall not be made before the first multi-site publication by Sponsor. If there is no multi-site publication

within eighteen (18) months after the Study has been completed or terminated at all Study sites, and all data

has been received, the Site shall have the right to publish its results from the Study, subject to the following

notice requirements. Prior to submitting or presenting a manuscript or other materials relating to the Study

to a publisher, reviewer, or other outside person, the Site shall provide to Sponsor a copy of all such

manuscripts and materials, and Sponsor shall have sixty (60) days from receipt of such manuscripts and

materials to review and comment. At Sponsor’s request, the Site shall remove any Confidential Information

(other than Institution Study results and Institution data) prior to submitting or presenting the materials.

The Site shall, upon Sponsor’s request, further delay publication or presentation for a period of up to one

hundred twenty (120) days to allow Sponsor to protect its interests in any Sponsor Inventions (as defined

below) described in any such materials.

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7. OWNERSHIP.

All documents, protocols, data, know-how, methods, operations, formulas and Confidential

Information provided to the Site pursuant to this Agreement are and shall remain Sponsor’s property. The

completed CRFs, the final report (if applicable) and other results of the Study, shall also be owned by

Sponsor. It is understood that Subject medical files kept at the Site in the normal course of business are not

the property of Sponsor, but shall be made available for review as required under the Protocol and Section

3 above.

8. INVENTIONS.

The pre-existing respective inventions and technologies of Sponsor and the Site are their separate

property and are not affected by this Agreement. The entire right, title and interest in and to any inventions,

discoveries, copyrights or other intellectual property rights that are conceived, developed, or reduced to

practice (including all improvements or modifications) which (i) incorporate or are anticipated by the

Protocol; (ii) are made as a result of conducting the Study; or (iii) rely, use, or incorporate any Confidential

Information, shall be the exclusive property of Sponsor (collectively referred to as “Sponsor Inventions”).

The Site shall promptly disclose in writing to Sponsor each such Sponsor Invention and shall assign (and

shall require all Study Site Team Participants to assign) to Sponsor all rights, title and interest, if any, in

and to each such Sponsor Invention. Site agrees to provide, at Sponsor’s expense, reasonable assistance to

Sponsor to enable Sponsor to perfect and enforce its rights in such Sponsor Inventions.

9. EQUIPMENT.

During the Study, Sponsor or Sponsor’s designee shall provide the site an I-STAT handheld

analyzer, along with cartridges, which shall be used only in accordance with the Protocol. Upon completion

or termination of the study, Sponsor may offer the site the option to purchase the I-STAT handheld analyzer,

or will require that the item be returned to Sponsor.

10. TERM; TERMINATION.

(a) This Agreement shall commence on the Effective Date and shall continue in force until the Study

has been completed at the Site, all data has been received and all queries resolved; provided,

however, that such completion takes no longer than five (5) years.

(b) This Agreement may be terminated by either party at any time for any reason upon thirty (30) days

written notice, or immediately upon written notice by any party for health or safety reasons.

(c) Upon material breach by a party, the other party may terminate this Agreement provided

that the other party fails to cure the breach within 30 days after notice.

(d) Upon the effective date of termination of this Agreement, an accounting shall be conducted by the

Site, subject to verification by Sponsor. Following receipt of adequate documentation, Sponsor

will pay for:

(i) all services properly rendered and monies properly expended by the Site through the

effective date of termination, which have not yet been paid by Sponsor; and

(ii) non-cancelable obligations that Sponsor would be obligated to pay per the Agreement, and

that are properly incurred for the Study by the Site prior to receipt of notice of termination.

(e) If the Site has been paid any amounts which have not been earned hereunder as of the date of

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termination, the Site shall promptly return to Sponsor all such unearned funds within 30 days.

(f) Immediately upon receipt of a notice of termination, the Investigator shall stop screening and

enrolling patients into the Study and shall, as directed by Sponsor, cease conducting Study

procedures on patients already enrolled in the Study to the extent medically permissible.

11. INSURANCE.

Institution is owned and operated by Clark County pursuant to the provisions of Chapter 450 of the

Nevada Revised Statutes. Clark County is a political subdivision of the State of Nevada. As such, Clark

County and Institution are protected by the limited waiver of sovereign immunity contained in Chapter 41

of the Nevada Revised Statutes. Institution is self-insured as allowed by Chapter 41 of the Nevada Revised

Statutes. Upon request, Institution will provide Sponsor with a Certificate of Coverage prepared by its Risk

Management Department certifying such self coverage.

During the performance of this agreement, the Sponsor shall carry clinical trials insurance with

limits of not less than $1,000,000 per occurrence and up to $3,000,000 in aggregate.

Sponsor shall, at Institution’s written request, have its insurance carrier for such insurance furnish

to Institution a certificate that such insurance is in force, such certificate to indicate any deductible and/or

self-insured retention and stipulate that such insurance will not be canceled or reduced while this Agreement

is in effect without at least thirty (30) days prior written notice to Institution.

The limits of any insurance coverage required herein shall not limit the Parties’ liability under the

indemnification provisions of this Agreement.

12. INDEMNIFICATION.

(a) Sponsor agrees to defend and indemnify the Institution and the Principal Investigator, and hold

them harmless from and against any liability, claim, loss, damages and expenses (including

attorney’s fees and costs of suit) (collectively, “Losses”) incurred by them in connection with any

and all suits, investigations, claims or demands made or brought by or on behalf of third parties

against the Institution or the Principal Investigator, to the extent arising out of or relating to (i) the

Protocol and any other written instructions of Sponsor; (ii) the performance of any procedure that

is required by the Protocol to which the subjects would not have been exposed but for their

participation in the Study; or (iii) Sponsor’s use of the data.

(i) Sponsor’s obligation to indemnify will not apply to the extent that such claims or

proceedings:

1. arise out of or relate to the negligence, willful misconduct or wrongful act

or omission of the Institution, Principal Investigator or any Study site staff;

or

2. arise out of or relate to the Principal Investigator’s or Institution’s failure

to report promptly to Sponsor any subject adverse event or serious adverse

event; or

3. arise as a result of Institution’s or Principal Investigator’s compromise or

settlement of any such claim without the written consent of Sponsor.

(b) Investigator agrees to defend and indemnify the Institution and Sponsor, and hold them harmless

from and against any liability, claim, loss, damages and expenses (including attorney’s fees and

costs of suit) (collectively “Losses”) incurred by them in connection with any and all suits,

Page 137 of 255




investigations, claims or demands made or brought by or on behalf of third parties against the

Institution or Sponsor, to the extent arising out of or relating to Investigator’s negligence, willful

misconduct or wrongful act or omission relating to the Protocol or otherwise in connection with

performance of this Study.

(c) Institution shall, to the extent expressly authorized by applicable Nevada law, indemnify, defend

and hold harmless Sponsor, its agents and employees (collectively the “ZS Pharma Indemnitees”)

from any and all third-party liabilities, claims, actions, or suits (collectively “Claims”) to the extent

they result from or arise out of the negligence or wrongful acts or omissions of Institution or

Investigator pertaining to the activities of the Study, treatment of patients and/or this Agreement.

(d) The indemnifications provided herein are subject to the following conditions, to the extent

expressly authorized by Nevada law:

(i) Institution shall not indemnify, defend and hold harmless the ZS Pharma Indemnitees from

Claims to the extent they result from or arise out of the negligence or wrongful acts or

omissions of the ZS Pharma Indemnitees;

(ii) The indemnifying party is promptly, and in any event within thirty (30) days after an

Indemnitee’s receipt of notice of any complaint, claim or injury relating to any loss subject

to this indemnification, notified in writing of any such complaint, claim or injury. However,

failure to provide prompt notice to the indemnifying party shall serve to reduce the

indemnity rights only to the extent that such delay or failure actually prejudiced the

indemnifying party’s ability to defend the claim, demand, or action;

(iii) Indemnifying party has sole control over the defense and settlement of any such claim or

suit, including the right to select defense counsel and to direct the defense or settlement of

any such claim or suit, provided that Institution shall not admit fault or liability on behalf

of any Indemnitee in the defense and settlement of such claim or suit; and

(iv) Indemnitees reasonably cooperate with the Indemnifying party and its legal representatives

in the investigation and defense of any claims or suits covered under this Section. In the

event that a conflict arises in the context of such an investigation or defense, the Indemnitees

shall have the right at their own expense to select and obtain representation by separate legal

counsel.

13. REPRESENTATIONS.

The Site represents that it has the experience, capability and resources including, but not limited to,

sufficient personnel and equipment to efficiently and expeditiously perform the Study according to the

Protocol and in a professional and competent manner. The Institution is authorized to enforce and shall

enforce the provisions of this Agreement with respect to all Study Site Team Participants.

14. CERTIFICATIONS.

(a) The Institution and the Investigator hereby individually certify that they have not been debarred

or disqualified from participating in clinical research under any laws or regulations. If during the

term of this Agreement, the Institution or the Investigator (i) becomes debarred or disqualified, or

(ii) receives notice or threat of an action with respect to its debarment or disqualification, the

Institution and/or the Investigator, as the case may be, shall notify Sponsor immediately.

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(b) The Institution and the Investigator hereby individually certify that they have not and will not use

in any capacity the services of any individual or entity which has been debarred or disqualified

from participating in clinical research under any laws or regulations. In the event that the

Institution or the Investigator becomes aware of the debarment, threatened debarment,

disqualification, or threatened disqualification of any such individual or entity, the Institution

and/or the Investigator, as the case may be, shall notify Sponsor immediately.

(c) The Site hereby certifies that if, rather than utilizing the central Institutional Review Board (“IRB”)

for the Study, Site engages an IRB related to this Study, that such IRB is registered and has

properly submitted an assurance application in accordance with the rules administered by The

Office for Human Research Protections of the U.S. Department of Health and Human Services.

Further, Site shall obtain informed consent of the Subjects participating in the Study in accordance

with applicable laws and regulations, and shall obtain IRB review and approval of the Protocol,

including informed consent form, in accordance with applicable laws and regulations. Prior to

enrolling any Subjects into the Study, Site shall provide Sponsor with evidence of such IRB

approval and a copy of the IRB-approved informed consent form, and shall promptly provide

Sponsor with a copy of any modified informed consent form later approved by the IRB.

(d) Sponsor agrees to promptly report to Institution findings that could affect the safety of Study

subjects or their willingness to continue participation, materially influence the conduct of the

Study, or alter the IRB’s approval to continue the Study.

15. ASSIGNABILITY.

No party may assign any its rights or delegate any performance under this Agreement, voluntarily or

involuntarily, whether by merger, consolidation, dissolution, operation of law, or any other manner without

the prior written consent of the other Parties, and any purported assignment or delegation without such

written consent is void. Notwithstanding the above, Sponsor may, without prior notice or consent,

assign this Agreement and its rights and obligations hereunder to a third party in connection with

the transfer or sale of all or substantially all of its business related to the subject matter of this

Agreement, or in the event of a change in control of Sponsor or its merger, acquisition,

consolidation or a similar transaction.

16. NOTICES.

With the exception of Study funds paid by Sponsor pursuant to Section 2 hereof, all notices

required or permitted to be given under this Agreement shall be in writing and shall be (a) delivered

personally, (b) sent by certified mail, or (c) sent by a nationally-recognized courier guaranteeing next-day

delivery, as follows:

If to Sponsor:

ZS Pharma, Inc.

508 Wrangler Drive, Suite 100

Coppell, TX 75019

Attention: Roland Winger

If to the Institution:


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1800 W. Charleston Blvd.

Las Vegas, NV 89102

Attention: CEO

Cc: Ron Roemer, Clinical Trials Office

With copy to the Investigator:

David Slattery, MD

109 Rancho Lane, Ste. 135

Las Vegas, Nevada 89106

17. USE OF NAMES.

The Institution and Investigator shall not use the name, symbols and/or trademarks of ZS or the

Sponsor in any form of publicity in connection with the Study unless approved in writing by the Sponsor

in advance.

18. WAIVER; SEVERABILITY.

No waiver of any term or condition of this Agreement whether by conduct or otherwise in any one

or more instances shall be deemed to be or construed as a further or continuing waiver of such term or

condition, or of any other term or condition of this Agreement. If any terms or conditions of this Agreement

are held to be invalid, illegal or unenforceable, the remaining terms and conditions contained herein shall

not be affected.

19. ENTIRE AGREEMENT; EXHIBITS; NO ORAL MODIFICATIONS; COUNTERPARTS.

This document, together with the Exhibits attached hereto, constitutes the full understanding of the

Parties and a complete and exclusive statement of the terms of their agreement with respect to the subject

matter hereof, and no terms, conditions, understanding or agreement purporting to amend, modify, vary or

waive the terms of this Agreement shall be binding unless made in writing and signed by an authorized

representative of each party hereto. This Agreement and any amendment hereto may be executed in several

counterparts, each of which shall be deemed an original but taken together shall constitute one and the same

instrument.

20. CONTINUING OBLIGATION; SURVIVAL OF PROVISIONS.

Except as otherwise specifically provided herein, termination of this Agreement shall not relieve

any party hereto from any obligation under this Agreement that accrued or arose from facts and

circumstances in existence prior thereto. In addition, the provisions of this Agreement that by their nature

contemplate continuing obligations shall survive expiration or termination of this Agreement.

21. Force Majeure.

(a) No party will be liable to the other for the failure or delay in performing its obligations under this

Agreement, if the failure or delay is due to causes beyond its reasonable control, including but not

limited to, acts of God, acts of government, terrorist activity, sabotage, expropriations, explosions,

wars, natural disasters, fire, earthquake, flood, or storm. If such an event occurs, or is suspected to

occur, the party unable to perform shall promptly notify the other party in writing,

and shall suspend performance only for such period of time as necessary and use reasonable efforts

to resume full performance of its obligations under this Agreement as quickly as possible. No party

is entitled to terminate this Agreement in such circumstances unless the condition delay exceeds

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ninety (90) days.

(b) If a party asserts force majeure as an excuse for failure to perform its obligation, then the

nonperforming party must prove that reasonable steps were taken to minimize delay or damages

caused by foreseeable events, that all non-excused obligations were substantially fulfilled, and that

timely notice was given of the likelihood or actual occurrence of an event described in Section

21(a).

22. Budget Act and Fiscal Fund Out.

In accordance with the Nevada Revised Statutes (NRS 354.626), the financial obligations under

this Agreement between the parties shall not exceed those monies appropriated and approved by UMC

for the then-current fiscal year under the Local Government Budget Act. This Agreement shall terminate

and Institution's obligations under it shall be extinguished at the end of any of Institution's fiscal years

in which Institution’s governing body fails to appropriate monies for the ensuing fiscal year sufficient

for the payment of all amounts which could then become due under this Agreement. Institution agrees

that this section shall not be used as a subterfuge or in a discriminatory fashion as it relates to this

Agreement. In the event this section is invoked, this Agreement will expire on the 30th day of June of

the current fiscal year. Termination under this section shall not relieve Institution of its obligations

incurred through the 30th day of June of the fiscal year for which monies were appropriated.

Signatures appear on following page.

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IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their duly

authorized representatives on the date(s) indicated below, but effective for all purposes as of the Effective

Date.

SPONSOR SITE

By: _____________________________ By: _____________________________

Authorized Signature Authorized Signature

Name: Henrik Rasmussen, MD, PhD Name: Mason VanHouweling

Title: Chief Medical Officer Title: CEO

Date: ____________________________ Date: ____________________________

INVESTIGATOR

By: _____________________________

Authorized Signature

Name: David Slattery, MD

Title: Investigator

Date: ____________________________

1/5/16

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EXHIBIT A

PAYMENT TERMS

Protocol Number ZS 007

1. Patient Enrollment – The Study is competitive for patient recruitment. Approximately 20-30

sites will be recruiting for a total of 200 eligible patients. Sponsor anticipates that the Site will

recruit approximately 10 patients, but makes no guarantees regarding this number. Sponsor

will advise on recruitment progress and notify sites when recruitment is complete. There is no

cap on the number of patients a site can enroll.

2. Non-payable Activities – Sponsor will not pay for any treatments given in violation of the

Protocol unless approved by the Sponsor, nor will Sponsor pay for any actions that violate

applicable laws or regulations.

3. Payable Activities – Sponsor will make payments based on subject visits that have been

entered into the EDC (Viedoc) system. The remote monitoring by EDC will be ongoing; on-

site monitoring visits will occur every 4 to 6 weeks for Source Document Verification review.

4. Payment Timing –

A. Site Activity Statements for protocol-required, study-related procedures will be

generated by ZS Pharma and sent to each site contact to be approved. Approved

activity statements will be emailed by site to George Pickard at

[email protected] for payment. These invoices will be paid within thirty (30)

days of receipt.

If the approved invoice cannot be emailed, it will be mailed to:

George Pickard

ZS Pharma

508 Wrangler Drive, Suite 100

Coppell, TX 75019

5. Payment Details – Sponsor will make payments by check, in USD. Checks shall be made

payable to:

Site Name: University Medical Center of Southern Nevada

Site Address: 1800 W. Charleston Blvd.

Las Vegas, NV 89102

Attn: Accounts Payable

Cc: Ron Roemer, Clinical Trials Office

6. Budget – The attached Budget (Separate Budget Grid) includes all fees payable. Sponsor will

pro-rate payments based on activities completed in compliance with the Protocol. All budget

amounts will be in U.S. Dollars (USD).

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7. Startup Payment and Pass-through Expenses –Sponsor will make a startup payment of

$9,050 as specified in the final Budget Grid. Upon activation, \the startup payment shall be

paid within thirty (30) days of receipt of invoice. The startup payment shall reimburse the Site

for work performed to prepare for activation and enrollment. Startup payments will be non-

refundable. Pass-through expenses will be paid by sponsor within 30 days of receipt of valid

invoice. A valid invoice must include the Protocol name and number and a detailed summary

of reimbursements to be made. Startup and pass-through expense invoices must be emailed

directly to George Pickard at [email protected].

8. Early Termination by Patients – Sponsor will make payments for patients who withdraw

early from the Study based on activities completed in compliance with the Protocol.

9. Ethics Committee/IRB Fees – Sponsor will directly pay Ethics Committee/IRB fees

submitted to Sponsor.

10. Interim Payments – Sponsor will withhold 10% of all payments for subject visits until

Sponsor issues the final payment as described herein. Sponsor will reimburse the Payee, in

accordance with the final Budget and these Payment Terms, the remaining 90% of fee payment

due (collectively, “Interim Payments”). Any unused portion of an advance payment made to

the Site will be offset against subsequent Interim Payments until such amount has been

exhausted.

11. Final Payment – Sponsor will pay the remaining 10% of fees owed when all data resolution

has been completed and accepted by Sponsor and when all Materials have been reconciled by

Sponsor.

Sponsor will conduct close-out visit after completion of Study Subject’s visits and within thirty (30) days

of Site’s written request.

Note: No other funding requests will be considered without the written consent of Sponsor.

.

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SEPARATE BUDGET GRID

Study budget – per patient

See attached excel spreadsheet

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Principal Investigator:

Study Coordinator:

Sponsor:

Title:

IRB Number:

Subjects:

Length of Study 8 months

Indirect rate:

Item/Service Screen Baseline 30 Mins 1 Hour 2 Hours 4 Hours 8 Hours 12 Hours24 Hours/

Discharge

Informed Consent 75$

Eligibility Criteria 50$

Demographics 50$

Medical History 100$

Prior & Current Meds 50$

Potassium Invoiceable 15$ 15$ 15$ 15$ 15$ 15$ 15$ 15$

Venipuncture Invoiceable 15$ 15$ 15$ 15$ 15$ 15$ 15$ 15$

Recording Chief Complaint 15$

Poss. Cause of Hyperkalemia 15$

NYHA Assessment (if Hx of HF) 15$

Concomitant Meds (for up to 24 hours) 5$ 5$ 5$ 5$ 5$ 5$ 5$

Adverse Events 10$ 10$ 10$ 10$ 10$ 10$ 10$

Vital Signs 40$

ECG 100$

Chest X-Ray report 100$

Data Collection and Reporting (includes:

Urine Intake and Output measurement (up

to 24 hours), Labs: CBC, CMP, BNP, N-

terminal proBNP, Troponin I or T, Physical

Exam (ER), Admitting and Discharge

Diagnoses, Discharge Summary, and

Billing Records) 125$ 125$

Chart Review (CV Adjudication) 200$

Patient Stipend 50$

CRC Effort 75$ 75$

PI Effort 50$ 50$

Sub Total 860$ 30$ 45$ 45$ 45$ 45$ 45$ 45$ 545$

Overhead 258$ 9$ 14$ 14$ 14$ 14$ 14$ 14$ 164$

Total 1,118$ 39$ 59$ 59$ 59$ 59$ 59$ 59$ 709$

Per Patient 2,217$

Total Patients 10 Sponsor makes no guarantee regarding number of patients site will enroll.

Per Patient Total 22,165$

Pass Through Fees (invoiceable)

Start Up fee 4,000$

IRB Initial Review 1,950$

CTO Fees 2,600$

Record Retention 500$

9,050.00$

IRB Continuing Review (annual)*1,300$

IRB Amendment*975$

Withdraw of ConsentPotassium 48$

Venipuncture 39$

Concomitant Meds 78$

ECG 130$

To support record retention as required by sponsor

Invoiced per Occurrence inclusive of Indirects

Assesed for annual renewal review of protocol and

study.

Assessed for amendments or modifications

requested by sponsor.

30%

Start Up Fees inclusive of Indirects

A non-refundable start-up fee is assessed to cover

the effort of the study team to open the study and

may include: protocol analysis, staff training,

development of study-specific documents, pre-

screening, recruitment activities, and study

team/sponsor communications.

Assessed for protocol review by the UMC IRB,

consent form preparation, IRB submission and

funding for education/training opportunities for IRB

members and administrative expenses for the IRB

support staff.

Assessed for complete administrative study set-up,

including: protocol review, regulatory document

collection and filing, development of Prospective

Reimbursement Analysis (PRA), study

communications, budget preparation, and contract

review.

10

David Slattery, MD

Wesley Forred

ZS Pharma, Inc.

A Multicenter, Prospective, Observational Study to Characterize the Management of Subjects With

15.08.010

CPT Code 84132 If second sample is required

CPT Code 36415 If second potassium required

Invoiced to sponsor if patient is hospitalized and

followed past 24 hours

CPT Code 93000 Invoiced to sponsor if required

for research

Sponsor will pro-rate based on procedures

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MEMORANDUM OF UNDERSTANDING

THIS MEMORANDUM OF UNDERSTANDING (“MOU”) is made and entered into by and between the DAVID SLATTERY, MD (“Investigator”) and UNIVERSITY MEDICAL CENTER OF SOUTHERN NEVADA (“UMC”) and is entered into concurrent with that certain Clinical Trial Agreement entered into between UMC, ZS PHARMA and INVESTIGATOR prior to this date or of even date herewith (the “Agreement”).

RECITALS

WHEREAS, UMC has agreed to serve as the Institution for a certain clinical research study bearing protocol number ZS-007, known as Clinical Protocol ZS-007 – A Multicenter, Prospective, Observational Study to Characterize the Management of Patients with Hyperkalemia Admitted to the Emergency Room (the “Study”) with Investigator, a physician fully privileged at UMC, who shall serve as Investigator under said Agreement. A true and correct copy of said Agreement is attached hereto as Exhibit A; and

WHEREAS, the parties are entering into this MOU as set forth in Section 2 (a) of the Agreement to further clarify their obligations to each other, in particular as it relates to the Budget and Indemnification for the Study as further described herein.

COVENANTS

NOW, THEREFORE, in consideration of the mutual covenants and conditions herein contained, the parties agree as follows:

1. Responsibilities of Investigator.

1.1 Conduct all activities relating to the Study in accordance with the Protocol.

1.2 Ensure that any staff provided by Investigator is qualified to provide services required under the Agreement.

1.3 Ensure compliance in accordance with the terms set forth in the Agreement and Protocol, and with all other applicable federal, international, state, and local laws, regulations, and policies that may provide additional protection for human subjects participating in research conducted under this agreement.

2. Responsibilities of UMC.

2.1 UMC will pay Investigator for the clinical trial services provided in accordance with the Budget which is attached hereto as Exhibit B. Investigator may invoice UMC for services provided no more frequently than monthly. UMC will pay University within thirty (30) days of receipt of payment from ZS Pharma for the services represented by each respective approved invoice.

2.2 UMC shall comply with the terms and conditions as set forth in the Agreement and protocol as Institution.

2.3 UMC shall fulfill all of Site’s obligations concerning IRB approval.

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3. Responsibilities of Investigator and UMC.

3.1 Investigator and UMC shall at all times cooperate for the purposes of fulfilling the obligations of each in accordance with the Agreement and the protocol and shall share information as appropriate and necessary to fulfill such purposes, including but not limited to any notices received from ZS Pharma or any regulatory body concerning the status of the respective parties that may affect the performance of any party to the Agreement.

4. Invoicing.

Invoices shall be delivered to:

University Medical Center of Southern Nevada Clinical Trials Office 1800 West Charleston Boulevard Las Vegas, NV 89102

Compensation checks shall be payable to “Nevada Emergency Medicine Research Foundation” and shall be delivered to: Dr. David Slattery Department of Emergency Medicine 901 Rancho Lane, Suite #135 Las Vegas, Nevada 89106

5. Term and Termination.

5.1 This MOU shall be in effect for the term of the Agreement unless terminated earlier as set forth in Section 5.2 or 5.3. 5.2 In the case of any breach of this MOU, either party may terminate with thirty (30) days advance written notice to the breaching party. Upon receiving notice of an alleged breach the party against which the breach is asserted shall have ten (10) days to cure the breach. If the breach is not cured within (10) days of notice, this MOU shall terminate.

5.3 Either party may terminate this MOU, without cause, upon thirty (30) days prior written notice to the other party. Such termination shall not relieve either party of any obligation or liability accrued hereunder prior to such termination, or rescind or give rise to any right to rescind any payments made prior to the time of such termination.

6. Notices. Except as provided in Section 4 hereof regarding payment of invoices, any notice or other communication required or permitted to be given to the other party shall be in writing and shall be deemed to have been properly given and effective: (a) on the date of delivery if delivered in person during recipient’s normal business hours; or (b) on the date of delivery if delivered by courier, express mail service or first-class mail, registered or certified, return receipt requested. Such notice shall be sent or delivered to the respective addresses given below, or to such other address as either party shall designate by written notice given to the other party as follows:

2

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To Investigator:

Dr. David Slattery Emergency Medicine Physicians 901 Rancho Lane, Suite #135 Las Vegas, NV 89106

Attn: Research Director

To UMC:

University Medical Center of Southern Nevada 1800 West Charleston Boulevard Las Vegas, NV 89102 Attn: Contracts Management

7. Insurance. Each party shall maintain an insurance policy at levels sufficient to support its obligation assumed under this MOU and as required by applicable law. This provision shall in no way be considered a waiver of UMC’s right to raise the defense of sovereign immunity under NRS 41.0305 to NRS 41.039, which right UMC specifically reserves. 8. Independent Entities. Each party recognizes that each is an independent entity and agrees that no party shall be liable for any other party’s contracts, obligations, torts, or representatives. Each party shall not be held out as liable for any other party’s contracts, obligations, torts or representatives. Each party shall not be responsible for the legal and/or contractual obligations related to employees of any other party. Each party shall be solely responsible for all state and federal laws pertaining to employment taxes, income withholding, unemployment compensation contributions and other related employment related statutes. 9. Governing Law. This MOU shall be governed by and constructed under the laws of the State of Nevada. Any legal action or dispute arising out of or in any way related to this MOU shall be brought in a state or federal court of competent jurisdiction in Nevada.

10. Severability. The parties recognize that this MOU is at all times subject to federal, state and local laws and regulations. The parties further recognize that this MOU shall be subject to any amendments to such existing laws and regulations and to new laws and regulations. In the event that any of the provisions or portions of this MOU are held to be unenforceable or invalid under any provisions of law or by any court of competent jurisdiction, the validity and enforceability of the remaining provisions or portions shall not be affected. The parties shall, within a reasonable period of time, attempt to negotiate a new MOU with respect to any provision determined to be inconsistent with or invalid under any new laws and may attempt to negotiate a new MOU in the event the MOU becomes null and void.

11. Waiver. The waiver by a party of any breach of any term, covenant or condition herein shall not be deemed a waiver of any subsequent breach of the same or any other term, covenant or condition of this MOU.

12. Entire Agreement, Modifications. This MOU, together with the Agreement, contains the entire agreement and understanding between the parties with respect to the subject matter hereof and supersedes all prior and contemporaneous agreements and understandings, express or implied, oral or written, with

3

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respect to the subject matter of this MOU and the Agreement. This MOU may not be altered, modified or amended except in writing and with the signature of both parties.

13. HIPAA Requirements. To the extent applicable to the Agreement and this MOU, University and UMC agree to comply with the Health Insurance Portability and Accountability Act of 1996, as codified at 42 USC 1320d (“HIPAA”) and any current and future regulations promulgated thereunder including without limitation the federal privacy regulations contained in 45 C.F.R. Parts 160 and 164 (the “Federal Privacy Regulations”), and the federal standards for electronic transactions contained in 45 C.F.R. Parts 160 and 162, all collectively referred to herein as “HIPAA Requirements.”, including the Health Information Technology for Economic and Clinical Health Act (“HITECH”) that was adopted as part of the American Recovery and Reinvestment Act of 2009. Both parties agree not to use or further disclose any Protected Health Information (as defined in 42 USC 1320d), other than as permitted by HIPAA Requirements and the terms of the Agreement and protocol. Both parties shall make their internal practices, books, and records relating to the use and disclosure of Protected Health Information available to the Secretary of Health and Human Services to the extent required for determining compliance with the Federal Privacy Regulations.

14. Fiscal Fund Out. It is understood and agreed, notwithstanding the provisions, terms and conditions of this MOU, that in the event any recognized funding authority fails to appropriate sufficient funds to UMC to enable obligations to be fulfilled under the MOU for the ensuing year or any part thereof, all rights and obligations of the parties under this MOU shall terminate upon thirty (30) days written notice. It is further understood and agreed that notwithstanding the provisions, terms and conditions of this MOU this paragraph shall be superseding. 15. Counterpart Signatures; Electronic Transmission. This MOU may be executed in any number of counterparts, each of which shall be deemed to be an original, and all of such counterparts shall constitute one MOU. Delivery of this MOU may be accomplished by electronic transmission of this MOU. 16. Assignment/Binding on Successors. No assignment of rights, duties or obligations of this MOU shall be made by either party without the express written approval of a duly authorized representative of the other party. Subject to the restrictions against transfer or assignment as herein contained, the provisions of this MOU shall inure to the benefit of and shall be binding upon the assigns or successors-in-interest of each of the parties hereto and all persons claiming by, through or under them. 17. Non-Excluded Healthcare Provider. Investigator represents and certifies to UMC that neither he nor any of his affiliates (a) are excluded from participation in any federal health care program, as defined under 42 U.S.C. §1320a-7b (f), for the provision of items or services for which payment may be made under such federal health care programs and (b) has arranged or contracted (by employment or otherwise) with any employee, contractor or agent that such party or its affiliates know or should know are excluded from participation in any federal health care program, to provide items or services hereunder. Investigator represents and certifies to UMC that no final adverse action, as such term is defined under 42 U.S.C. §1320a-7e (g), has occurred or is pending or threatened against Investigator or his affiliates or to his knowledge against any employee, contractor or agent engaged to provide items or services under this MOU (collectively “Exclusions / Adverse Actions”).

SIGNATURE PAGE FOLLOWS

4

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IN WITNESS WHEREOF, the parties have caused this MOU to be duly executed as of the dates set forth below. DAVID SLATTERY, MD By: ___________________________________________

David Slattery, MD Date Investigator

UNIVERSITY MEDICAL CENTER OF SOUTHERN NEVADA By: ________________________________________ Mason VanHouweling Date Chief Executive Officer

5

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Exhibit A


(See next page) 6

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Exhibit B

BUDGET

Per Patient Reimbursement to Investigator: $ 551.67

Potential Patients 10 (potentially)

Total $ 5,516.70

Invoiceable at Start Up

Start Up fee*

A non-refundable start-up fee is assessed to cover the effort of the study team to open the study and may include: protocol analysis, staff training, development of study-specific documents, pre-screening, recruitment activities, and study team/sponsor communications.

$ 1,000

*Reimbursement is for Principal Investigator’s effort and includes institutional overhead. Total reimbursement not to exceed $6,516.70

7

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INDEMNITY LETTER AGREEMENT

20 January 2016 Mr. Mason VanHouweling CEO University Medical Center of Southern Nevada 1800 W Charleston Blvd. Las Vegas, NV 89102 Protocol Number: INN-CB-014, entitled “A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety the XaraColl® Bupivacaine Implant (300 mg Bupivacaine Hydrochloride) After Open Laparotomy Hernioplasty” – Letter of Indemnification Dear Mr. VanHouweling: This letter will set forth the terms and conditions under which Innocoll Pharmaceuticals Inc. (“Sponsor”) shall provide indemnification for University Medical Center of Southern Nevada (“UMC”) in connection with Study Protocol Number INN-CB-014 and subsequent amendments (“Protocol”). UMC has agreed to serve as the Facility for the Study, and has signed a Facility Use Agreement (“Agreement”) dated January 18, 2015. Unless otherwise specified in this Letter Agreement, the terms and definitions of the Agreement shall apply equally to this Indemnity Letter Agreement. To the extent that there exists a conflict in the terms of the Agreement and this Indemnity Letter Agreement, the terms of this Letter Agreement shall prevail in matters related to indemnification. Sponsor agrees to indemnify and hold harmless UMC from any and all liability, loss, or damage it might suffer as a result of claims, demands, costs or judgment against it connected with the performance of the activities carried out pursuant to the Protocol, except to exclude from this Letter Agreement an indemnity for any claims, demands, cost, or judgments which are or alleged to be arising from: prior treatment giving rise to the condition for which research drug is being used; the gross negligence or willful misconduct on the part of UMC; or a breach of any applicable federal, state or local law by UMC; or any matter outside the direct control of Sponsor. Additionally, if Section 7 (c) of the Facility Use Agreement is invoked, Sponsor shall indemnify and defend UMC from any claims or actions, including all associated costs and attorney’s fees, demanding the disclosure of Medpace or Sponsor document(s) in Surgical Center’s custody and control that Sponsor claims to be confidential and proprietary, except to exclude an indemnity for any claims, demands, cost, or judgments which are or alleged to be arising from: the gross negligence or willful misconduct on the part of UMC; or a breach of any applicable federal, state or local law by UMC. To the extent expressly authorized by Nevada law, UMC agrees to accept responsibility and hold Sponsor harmless from any and all liability, loss, or damage it might suffer as a result of claims, demands, costs or judgment which are or alleged to be arising out of: the gross negligence or willful misconduct on the part of UMC; or a breach of any applicable federal, state or local law by UMC. Conditions for Indemnification. Sponsor’s indemnification obligations shall be subject to the following conditions:

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Page 2 of 3

1. UMC shall serve as Facility for the Study in a normal, prudent manner and with utmost skill, care and diligence;

2. UMC shall maintain properly and, if requested, promptly make available to Sponsor records concerning the receipt, storage, handling use and administration of the Investigational Product and any comparator substances;

3. UMC shall adhere to the terms and conditions of the Facility Use Agreement dated January 18, 2016.

4. Sponsor will not indemnify UMC for any settlement that UMC enters into without Sponsor’s prior written consent;

5. UMC will not, without the prior written consent of Sponsor voluntarily make any payment in connection with any claim, unless the payment is made in a case of legitimate medical emergency to ensure that proper medical treatment is provided to a subject enrolled in the Study. In the later situation, Sponsor will reimburse UMC only for those vouched payments incurred in the case of a medical emergency to provide medical treatment for a subject’s injury or illness that is determined to be the result of participation in the Study and provided the Sponsor is immediately notified of such circumstances;

6. UMC shall tender all reasonable assistance to Sponsor in defending any claim subject to the Sponsor’s indemnification and reasonably cooperate with and assist Sponsor in the gathering of information related to and in defense of the claim;

7. UMC shall provide Sponsor written notice of any claims of damages or loss with regard to the Investigational Product or Protocol against UMC as soon as UMC receives notice thereof, regardless of whether UMC intends to make an indemnification claim against Sponsor;

8. UMC shall provide all reasonable assistance to Sponsor and its authorized representatives in the investigation, negotiation, settlement and defense of any claim, demand, legal proceeding or damages to which indemnity otherwise applies; and

9. Sponsor shall be given immediate and sole control of any such investigation, negotiation, settlement

and defense of any such claim or lawsuit. Additionally, notwithstanding anything in this Letter Agreement or the CTA, Innocoll will reimburse UMC if Medpace or Principal Investigator admits subject(s) into the Study in violation of the Protocol or who do not conform to the Protocol’s inclusion and exclusion criteria or for whom serious deviations from the Protocol are made.

THIS SPACE LEFT INTENTIONALLY BLANK. SIGNATURE PAGE FOLLOWS.

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Page 3 of 3

If the terms of the above letter meet with your approval, please counter sign below. Innocoll Pharmaceuticals Inc. 3813 West Chester Pike, Newtown Square PA19073 Name: ___________________________ Nigel Jones Title: Vice President, Global Clinical Operations Date: ________________________ University Medical Center of Southern Nevada (Facility) Name: Mason VanHouweling Title: CEO Date: ________________________

4 January 2016

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FACILITY USE AGREEMENT

This agreement ("Agreement"), effective as ofJanuary 18, 2016 (the "Effective Date"), is entered into by and between Medpace, Inc., with its principal office and place of business at 5375 Medpace Way, Cincinnati, Ohio 45227 ("Medpace"), and University Medical Center of Southern Nevada, a publicly owned and operated hospital created by virtue of Chapter 450 of the Nevada Revised Statutes, with its principal place of business at 1800 W. Charleston Blvd., Las Vegas, NV 89102 ("Facility"). Medpace and Facility are sometimes collectively referred to herein as parties (the "Parties").

WHEREAS, Innocoll Pharmaceuticals ("Sponsor") is sponsoring the Study (as defined below), and Facility possesses certain facilities including but not limited to premises, equipment and staff which are necessary for Institution and Principal Investigator's performance of the Study; and

WHEREAS, University ofNevada, Reno, a clinical research site and state-controlled institution of higher education with its principal office and place of business at 1664 North Virginia Street, Mail Stop 325, Reno, NV 89557, and 1707 W. Charleston Blvd. Suite 160, Las Vegas, NV 89102 ("Institution") has agreed to participate as a clinical research site in the Study; and

WHEREAS, Medpace is a contract research organization which has been contracted by Sponsor to manage and administer the Study, and Medpace and Institution have entered into a Clinical Study Agreement for performance of the clinical study Protocol No. INN-CB-014 ("Protocol"), entitled "A Phase 3 Randomized, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of the XaraColl Bupivacaine Implant (300 Bupivacaine Hydrochloride) After Open Laparotomy Hemioplasty" (the "Study"). Institution remains subject to all the terms and conditions of the Clinical Study Agreement; and

WHEREAS, Medpace and Institution desire for portions of the Study to be conducted at Facility in accordance with the terms and conditions of this Agreement. Dr. Charles St. Hill ("Principal Investigator") will be carrying out some of his duties as Principal Investigator pursuant to the Clinical Study Agreement at Facility. For purposes of this Agreement, the term "Facility" shall include all employees, faculty and other authorized agents of the Facility. Medpace acknowledges that Institution is a separate legal entity from Facility, and that Facility is not construed as being engaged in research with respect to the Study.

NOW THEREFORE, in consideration of the foregoing and the mutual covenants and promises set forth herein and other good and valuable consideration, the receipt and adequacy of which are hereby acknowledged, the Parties agree as follows:

1. Facility Performance. Facility shall perform its obligations under this Agreement in accordance with generally accepted standards of good clinical and medical practices, and all applicable laws, rules and regulations.

2. Debarment. Facility is not currently using, and shall not use the services of any person who is debarred or proposed for debarment under the Federal Food, Drug, and Cosmetic Act, as amended.

3. Compensation. Payment will be made by Medpace or its designee to the payee ("Payee") designated in Schedule A appended hereto and incorporated herein by reference. Facility will accept payment from Medpace, or its designee, to the Payee as full consideration for services rendered. All costs outlined on Schedule A shall remain firm for the duration of the Study, unless otherwise agreed to in writing by Facility and Medpace. The budget contained in Schedule A is inclusive of all applicable taxes. Medpace, as Sponsor's payment agent, shall make payment to Payee under this Agreement from funds escrowed by Sponsor. Notwithstanding the foregoing, Medpace may issue a written amendment, signed only by Medpace, for the purpose of increasing the Study costs as described in the Schedule A.

Protocol No. CB INN-CB-014 Site 418: Charles St. Hill

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4. Rights to Publication. Facility shall not publish or make any presentation concerning the Study without the prior written permission of Sponsor.

5. Ownership ofMaterials and Intellectual Property.

(a) Sponsor shall own all right, title and interest (collectively "Rights") in and to any equipment, methods, data, documents, information and other materials supplied to Facility by or on behalf of Sponsor (collectively "Materials").

(b) Sponsor shall own all Rights in and to each invention, discovery, know-how, tradesecret and other intellectual property, including improvements, whether patentable or not, that is conceived, reduced to practice or otherwise made by Facility (whether solely or jointly with others}as a result of or in connection with the Study, XaraColl Bupivacaine Implant (300 Bupivacaine Hydrochloride) ("Study Drug"), or the performance of obligations under this Agreement, including any patent, trade secret, trademark, copyright or other proprietary right with respect thereto (collectively, the "Inventions"). The Facility shall promptly take any actions necessary to assign and transfer all of its rights in each Invention to Sponsor, including disclosing to Sponsor in writing the conception, reduction to practice or making of such Invention, and, without additional consideration, assigning and transferring to Sponsor all rights to patents, patent applications and rights to file for patent protection for such Invention throughout the world.

6. Access to Facility and Audits.

(a) Medpace and/or Sponsor shall have the right to monitor or inspect progress of the Study on the premises of Facility at reasonable times during the term of this Agreement. Medpace and/or Sponsor will notifY Facility prior to any monitoring visit or inspection of the date and time of the inspection/monitoring visit.

(b) Within twenty-four (24) hours after learning of any Food and Drug Administration ("FDA") or other governmental or regulatory body (e.g., Institutional Review Board, Drug Enforcement Agency) regulatory inspections of which it becomes aware relating to the Study, Facility shall provide written notification to Medpace and Sponsor. Medpace and Sponsor shall have the right to be present at any such inspections and shall have the opportunity to provide, review, and comment on any responses that may be required. Further, Facility will provide in writing to Medpace and Sponsor copies of all materials, correspondence; statements, forms and records which Facility receives or obtains pursuant to this inspection in accoradance with all applicable law ..

7. Confidential Information.

(a) For purposes of this Agreement, "Confidential Information" means any information of Sponsor or Medpace, whether of a technical, business or other nature, including this Agreement, and information.that relates to the Study or to Medpace or Sponsor's trade secrets, products, promotional material, developments, proprietary rights or business affairs, together with any Inventions, and all other information, data and results collected, prepared, developed or generated with respect to the Study pursuant to the Clinical Trial Agreement and this Agreement.

(b) During the term of this Agreement and for a period often (10) years after the termination of this Agreement, Facility shall not, without Medpace and Sponsor's prior written consent, disclose to any third party any Confidential Information, and shall use such Confidential Information solely for purposes of performing its obligations under this Agreement. The Facility shall restrict the dissemination of Confidential Information to only those persons within its organization who have a need to know, and shall ensure that they are aware of the obligation of confidentiality required by this Agreement and are similarly bound. The Facility shall use at least the same care and discretion in maintaining the confidentiality of the Confidential Information as the Facility uses with its most sensitive confidential information.

Protocol No. CB /NN-CB-014 Site 4 I 8: Charles St. Hill

Page 2 of7 fiNAl.

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(c) Notwithstanding the foregoing, Medpace acknowledges that Facility is a public, county-owned hospital which is subject to the provisions of the Nevada Public Records Act, Nevada Revised Statutes Chapter 239, as may be amended from time to time. As such, its contracts are public documents available for copying and inspection by the public. If Facility receives a demand for the disclosure of any information related to this Agreement which Medpace or Sponsor have claimed to be confidential and proprietary, Facility will immediately notifY Medpace and Sponsor of such demand and Medpace or Sponsor shall immediately notifY Facility of its intention to seek injunctive relief in a Nevada court for protective order.

8. Termination. Either Party may terminate this Agreement on thirty (30) days' written notice to the other Party. Notwithstanding the foregoing provision, Medpace may immediately terminate this Agreement if Facility breaches or threatens to breach any provision of this Agreement, or for safety concerns, or as otherwise required by applicable laws, upon written notice to Facility. Upon termination of the Agreement, Facility shall, at Medpace's reasonable expense: (a) immediately turn over to Medpace all Study documentation and materials in its possession associated with the Study; (b) at Medpace's direction, dispose of any quantities of unused Study Drug, in accordance with Medpace's written instructions; (c) cease permitting the performance of any procedures related to the Study; and (d) provide such other assistance as is necessary to ensure a smooth and orderly transition of the Study that will not involve any disruption of the Protocol. In any event. this Agreement will immediately terminate upon termination or expiration of the Clinical Study Agreement or upon Facilitv's receipt of notice from Sponsor or Medpace of the early termination of the Study.

9. Survival. The respective rights and obligations of the Parties set forth in Sections 4, 5, 6, 7 and 8 and this Section 9 shall indefinitely survive the termination or expiration of this Agreement to the extent necessary to preserve such rights and obligations.

10. Notices. Any notice required or permitted under this Agreement shall be in writing and shall be deemed made and given three (3) days after sending, if mailed by registered or certified mail, postage prepaid, return receipt requested, or one ( 1) day after sending, if sent by express courier service or facsimile transmission. All notices must be addressed to the contact set forth below:

IF TO MEDPACE: Medpace, Inc. Attention General Counsel 5375 Medpace Way Cincinnati, OH 45227

IF TO FACILITY: University Medical Center of Southern Nevada Attn: CEO 1800 W. Charleston Blvd. Las Vegas, NV 89102

IF TO SPONSOR: Nigel Jones VP, Global Clinical Operations 26 Salem Way 3813 West Chester Pike, Newtown Square, PA 19073 [email protected]

11. Assignment and Delegation. This Agreement, and all rights, duties and obligations hereunder, may not be assigned or delegated by Facility without the prior express written consent ofMedpace. Any attempt made by Facility to assign or delegate this Agreement in violation of this section shall be of no

Protocol No. CB INN-CB-014 Site 418: Charles St. Hill

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force or effect. Facility acknowledges that Medpace shall have the right to assign or delegate this Agreement or any portion thereof without the consent of Facility.

12. Independent Contractors. The relationship of the Parties is that of independent contractors, and no employment or agency relationship shall be construed to exist between the Parties. Neither Medpace nor Sponsor shall be responsible for any employee benefits, pensions, workers' compensation, withholding or employment-related taxes relating to Institution, Principal Investigator or Facility.

13. Sponsor As Third Party Beneficiary. The Parties to this Agreement recognize and agree that Sponsor takes the benefit of this Agreement as a third-party beneficiary and agree that Sponsor may enforce such rights either directly itself or indirectly through Medpace.

14. Entire Agreement: Amendment. This Agreement constitutes the entire agreement between the Parties and all prior agreements between the Parties with respect thereto are superseded. Notwithstanding the foregoing, the Clinical Study Agreement between Medpace and Institution shall not be superseded by this Agreement. No amendment or modifications to this Agreement shall be binding unless in writing and duly executed by authorized representatives of Facility and Medpace.

15. Signing Authority. The undersigned are authorized to execute this Agreement on behalf of the Parties, and upon such execution, this Agreement shall be the legally binding obligation of the Parties, enforceable in accordance with its terms.

ACCEPTED AND AGREED:

MEDPACE, INC.

By: C\'- f2v ~.:;;: Name::

I

I

Title: ~ I

Tina Roberts Director

Clinical Trial Management

Protocol No. CB /NN-CB-014 Site 418: Charles St. Hill

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FACILITY

By: __________ _

Name: Mason VanHouweling

Title: CEO

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Protocol No. CB JNN-CB-014 Site 418: Charles St. Hill

E p CE THE ADVANTAGE OF FOCUS

SCHEDULE A-FACILITY

JNNOCOLL

PROTOCOL ID: INN-CB-014

CHARLES ST. HILL

SITE:418

SCHEDULE A VERSION DATE: 18-SEP-2015

SCHEDULE A VERSION: VERSION #2

COUNTRY: UNITED STATES

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SCHEDULE A

A 1 STUDY BUDGET Medpace, as Sponsor's payment agent, shall make payment to the payee specified in the Payee Information Table ("Payee") under this Agreement from funds escrowed by Sponsor for services provided according to the payment schedule below. All fees listed include overhead and taxes, as applicable. All amounts shown herein are calculated in USD.

A2 SETUP FEES & VISIT PAYMENTS

A2.1 Setup Fees

rPh;~;~;J~iti;ti~~--F~~-C-'-·''

Payment will be made within forty-five (45) days of:

Sponsor declaring Institution to be ready for Study Initiation;

IRB/EC approval; and

Medpace's receipt of the fully executed Agreement.

A3 INVOICEABLE ITEMS Payment will be made within forty-five (45) days of receipt of invoice and supporting documentation.

A3. 1 Surgery Fee

Including but not limited to: Facility and Medication/Supply Fees associated with surgery and other post-operative requirements, payable upon receipt of itemized invoice.

A3.2 Pharmacy Maintenance Fee

Medpace will pay Payee an annual pharmacy maintenance fee once a year upon receipt of itemized invoice.

$3,720

$1,560 I Year

A3.3 Drug Dispensing PPT (xl 0) $130 I Procedure Medpace will pay Payee to cover the cost of drug dispensing, payable upon receipt of itemized invoice and supporting documentation.

A3.4 Study Close Out Fee

Medpace will pay Payee a one-time study close-out fee, payable upon itemized invoice at study close-out.

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A4 MEDPACE INVOICING All payment inquiries and invoices submitted shall include the Protocol number and Principal Investigator name and be sent to the following:

Email: [email protected] Medpace, Inc.

Phone: 513-579-9911 Attn: Clinical Operations Site Payments

5375 Medpace Way

Cincinnati, Ohio 45227

All invoices must be submitted to Medpace within ninety (90) days of occurrence or up to fifteen (15) days after receipt of the final payment.

AS PAYEE INFORMATION All payments made by Medpace as set forth herein shall be payable solely to Payee at the address set forth below. Any such payments which are due to any other party performing services in connection with the Study shall be a matter solely between Payee and such party. ·

11 l'"'""'rsity Medical Center of Southern ~~va~~----~~···· Attn: Accounts Receivable 1800 W. Charleston Blvd. Las NV 89102

I Email Address -···········--"-"'''''~-~-.. ~--~-~-~- .. --------~ .. ·--------·-.. ··-···---\

[email protected] -----~--------.. ·····'! Andrea.Hermann(cl),umcsn.com __ ! --~-~+===~===-==--=-===~~ =======-I_ Attention Ronald Roemer , __ -----------+A __ nd_r_e_a_~(A_n_d_i~)_H_e_rm_a_n_n ________________ ·---------------4 [!ax ID# 88-6000436 .................................................................. I

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CLINICAL TRIAL AGREEMENT This Agreement by and between Janssen Scientific Affairs, LLC (“Sponsor”), with offices at 1125 Trenton-Harbourton Road, Titusville, NJ 08560; University Medical Center of Southern Nevada (“UMC”), a publicly owned and operated hospital created by virtue of Chapter 450 of the Nevada Revised Statutes located at 1800 W. Charleston Blvd., Las Vegas, NV 89102; and Dr. David Slattery, MD (“Principal Investigator”), a fully priviledged physician of UMC. UMC and Principal Investigator may be collectively referred to as the “Institution”. The Agreement is made and effective as of the date of execution that the last party signs below (hereinafter “Effective Date”). Background WHEREAS, Sponsor has requested Institution and its employees to conduct a clinical research study involving the study drug Rivaroxaban (the “Study Drug”) according to Protocol 39039039APE4001 (the "Protocol") entitled “Multicenter Trial of Rivaroxaban for Early Discharge of Pulmonary Embolism from the Emergency Department (MERCURY PE)” (the "Study"), incorporated herein by reference as Exhibit A, and all subsequent Protocol amendments; and

WHEREAS, Institution is equipped to undertake the Study and agrees to perform the Study on the terms and conditions hereinafter set forth. NOW, THEREFORE, in consideration of the premises and the mutual promises and covenants expressed herein, the parties agree as follows: 1. Performance of Study.

A. Compliance With This Agreement. Institution agrees to perform the Study in strict compliance with

the Protocol and the terms and conditions of this Agreement. In the event that UMC and/or Principal Investigator use the services of sub-investigators, investigational staff, or others to conduct the Study pursuant to this Agreement, UMC and Principal Investigator shall be responsible for ensuring that all are appropriately licensed and credentialed and in compliance with the terms of this Agreement. Institution shall be liable for any breach of this Agreement by such individuals.

B. Replacement of Principal Investigator. In the event that the Principal Investigator is no longer affiliated with UMC, UMC shall provide written notice to Sponsor within three (3) days of such departure. Sponsor shall have the right to approve any new Principal Investigator designated by UMC. The new Principal Investigator shall be required to agree to the terms and conditions of this Agreement. In the event Sponsor does not approve such new Principal Investigator, Sponsor may terminate this Agreement in accordance with the Termination Section below and UMC shall take all necessary steps to accommodate Sponsor’s decision in an efficient manner.

C. Blinding the Study; Use of Randomization Codes. Where a Protocol calls for a Study to be blinded, the Institution agrees to maintain the blinding of the Study Drug. The Institution understands that the randomization codes will be released upon completion of the Study and finalization of the database by Sponsor. For multi-center studies, data from all centers are required before the Study is considered complete. Should a medical emergency occur requiring the Principal Investigator to break the code for a specific subject, the Institution agrees to notify Sponsor immediately.

D. Delegation of Investigator Duties. Principal Investigator will personally supervise the Study and may not delegate this duty to any other individual without Sponsor’s prior written approval. He/she may, however, delegate other duties as necessary to other investigators and qualified personnel in accordance with regulatory requirements and upon notice to Sponsor. Institution may not replace Principal Investigator without Sponsor’s prior written approval. If Principal Investigator is to be temporarily absent from UMC, UMC shall designate an investigator qualified and trained to assume

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such responsibilities to temporarily supervise the Study on the Principal Investigator’s behalf. UMC shall document this designation and notify Sponsor in writing of such designation prior to its commencement.

E. Investigator and Staff Training. Institution shall ensure that Principal Investigator, other investigators, and designated staff attend all trainings conducted by Sponsor or its designee in the proper performance of the Study under the Protocol, safety and reporting requirements, and any other applicable guidelines as determined by Sponsor to be relevant to the conduct of the Study.

F. Use of Study Drug. Institution shall not make any use of Study Drug provided by Sponsor other than for the performance of the Study in accordance with the Protocol and this Agreement.

G. Additional Research. Institution shall not conduct any research, nor facilitate third parties to conduct any research, not required by the Protocol on (i) Study subjects during the course of the Study (including any additional research technique, procedure, questionnaire, or observation), or (ii) biological samples collected during the course of the Study from Study subjects or (iii) the data derived from the Study, each of (i), (ii) and (iii) without the prior written consent of Sponsor. Hereinafter, the research described in the previous sentence shall be referred to as “Additional Research”. In any case where Sponsor gives such approval, the approved Additional Research shall be considered either an amendment to the original Protocol, or shall be the subject of another written agreement between Sponsor and Institution. Institution shall conduct all such research in compliance with all federal and state laws and regulations, including requirements for obtaining appropriate IRB approval and subject informed consent. Without limiting any other remedy available by law to Sponsor, if Institution conducts Additional Research in breach of this section, and such Additional Research results in an invention, Institution hereby grants to Sponsor an irrevocable, worldwide, paid up, royalty-free, exclusive license, with right of sub-license, to make, have made, use, have used, sell, have sold, and import any invention that results from such Additional Research.


A. Term. The term of this Agreement shall begin on the Effective Date and shall end on the later of (i) April 30, 2017, or (ii) six (6) months following final database lock. The parties agree that the term may be extended by mutual written agreement if events beyond the parties' control delay completion of the Study beyond the expiration date.

B. Termination. Sponsor may terminate this Agreement (a) at any time in the exercise of its sole

discretion upon fifteen (15) days prior written notice to Institution either directly or through Principal Investigator or (b) immediately if Sponsor determines patient safety may be at risk, or (c) upon material breach of the Agreement. Upon receipt of such notice, Institution agrees to promptly terminate conduct of the Study, to the extent medically permissible, for all subjects. This Agreement may be terminated by Institution upon thirty (30) days prior written notice of termination for the material breach by Sponsor if said breach is not cured within said thirty (30) day period.

C. Payment Upon Termination. Upon any early termination for any reason other than the breach of this Agreement by UMC, Sponsor shall reimburse UMC for pre-approved expenses and noncancellable commitments made or incurred in accordance with this Agreement, prior to UMC's receipt of a notice of termination (reduced by all applicable prior payments made by Sponsor under this Agreement). No cancellation penalty payments shall apply. Upon receipt of such notice of termination, UMC shall use all reasonable efforts to avoid incurring additional costs and expenses and shall apply all advance payments made by Sponsor for this Agreement toward actual fees and costs incurred as of the effective date of termination. In the event Sponsor has prepaid any portion of payment for work pursuant to this Agreement that is not actually performed as a result of termination hereunder, UMC shall reimburse Sponsor for such unperformed services or unexpended or cancelled fees.


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D. Disposition of Study Drug and Confidential Information. Study Drug is provided solely for

Institution’s conduct of the Study. Institution shall not use the Study Drug other than for the performance of the Study in strict accordance with the Protocol and this Agreement and shall account for and return to Sponsor, or otherwise dispose of in accordance with Sponsor’s instructions, any unused Study Drug and all Sponsor Confidential Information, as defined in the Confidentiality Section of this Agreement, at the earlier of the conclusion of the Study or termination of this Agreement. In the event that unused Study Drug is destroyed at UMC, UMC shall promptly provide Sponsor with a copy of its “Certificate of Destruction”.

3. Institutional Review Boards/Informed Consent.

A. Institutional Review Board (“IRB”). Institution shall be responsible for obtaining approval of the

Protocol, informed consent, Study advertisements (if any), any alteration to or waiver of any subject authorization permitting the disclosure of confidential subject information in connection with the Study, and any matter involving questions of human subject protections, from the appropriate IRB prior to commencement of and during the performance of the Study. In the event the IRB requires changes in the Protocol or informed consent, such changes shall not be implemented until Sponsor is notified and gives its approval. The Protocol, the informed consent, and any advertising shall not be revised without the prior written agreement of Sponsor and the IRB. In the event the IRB withdraws approval of the Study, Institution shall promptly notify Sponsor of withdrawal of IRB approval of the Study.

B. Informed Consent. Institution shall also be responsible for obtaining an informed consent document signed by or on behalf of each human subject, which informed consent document shall be the document approved by Sponsor and the IRB, prior to the subject's participation in the Study. The informed consent shall include the right for Sponsor and its designees and applicable government authorities to review raw Study data, including original subject records, in all monitoring and auditing activities required to ensure quality assurance and compliance with the Protocol as well as all legal and regulatory requirements

4. Ownership of Data, Confidentiality, Publication and Registration.

A. Ownership. All case report forms and other data (including without limitation, written, printed,

graphic, video and audio material, and information contained in any computer data base or computer readable form) generated by the Institution and personnel in the course of conducting the Study (the "Data") shall be the property of Sponsor, which may utilize the Data in any way it deems appropriate, subject to and in accordance with applicable state and federal privacy laws and Exhibit C, the Data Use Agreement. Any copyrightable work created in connection with the performance of the Study (except any publication by the Principal Investigator as provided for hereafter) shall be considered a “work made for hire” to the fullest extent permitted by law, and owned by Sponsor or its designee. UMC may not use the Data for any commercial purposes including the filing of a patent application or the filing of the Data in support of any pending or future patent application or for the benefit of any for-profit entity, including use of Data in support of research for or in collaboration with a for-profit entity.

B. Confidentiality. All information, including, but not limited to, the Study Drug, the terms and conditions of this Agreement, the Protocol, or Sponsor’s operations, such as Sponsor’s patent application, formulas, manufacturing processes, basic scientific data, prior clinical research data and formulation information supplied by Sponsor to UMC, Principal Investigator, or other personnel involved with the Study and not previously published (the “Sponsor Confidential Information”) as well as Data are considered confidential and shall remain the sole property of Sponsor. Both during and after the term of this Agreement, Institution will use diligent efforts to maintain in confidence and use only for the purposes contemplated in this Agreement (i) the Sponsor Confidential Information, (ii) all information which a reasonable person would conclude is the confidential and


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proprietary property of Sponsor and which is disclosed by or on behalf of Sponsor to Institution, and (iii) the Data. The preceding obligations shall not apply to Data, Sponsor Confidential Information or information that falls under Section 4B(ii) (a) which has been published through no fault of Institution, (b) which Sponsor agrees in writing, may be used or disclosed, or (c) which is published in accordance with the Publication Section of this Agreement.

C. Compelled Disclosures. In the event the Institution (or any person to whom it has transmitted the Sponsor Confidential Information received hereunder) is required by law or legal process to disclose any of such Sponsor Confidential Information, the Institution will (i) (i) provide the Sponsor with prompt notice of such event so that the Sponsor may take appropriate steps, including intervening, to protect the confidentiality of the Sponsor Confidential Information and (ii) use reasonable efforts to obtain assurance that confidential treatment will be afforded to the Sponsor Confidential Information to be disclosed. and (ii) use reasonable efforts to obtain assurance that confidential treatment will be afforded to the Sponsor Confidential Information to be disclosed. Institution shall furnish only that portion of the Sponsor Confidential Information which is legally required to be disclosed. Sponsor acknowledges Institution is a public, county-owned hospital which is subject to the provisions of the Nevada Public Records Act, Nevada Revised Statutes Chapter 239, as may be amended from time to time. As such, its contracts are public documents available for copying and inspection by the public. If Institution receives a demand for the disclosure of any information related to this Agreement that Sponsor has claimed to be confidential and proprietary, such as Sponsor’s pricing, programs, services, business practices or procedures, Institution will immediately notify Sponsor of such demand and Sponsor shall immediately notify Institution of its intention to seek injunctive relief in a Nevada court for protective order.

D. Publication. In connection with any Data or other information generated from the services conducted hereunder by or on behalf of the Institution or other personnel associated with this Study, Sponsor shall have the right to publish such Data and information without approval from the Institution, and may do so in a timely manner to meet obligations for such data disclosure under the Food and Drug Administration Amendments Act (42 U.S.C. § 282) or any other applicable laws or regulations. Moreover, if publication of the Study to the peer reviewed literature has not occurred within twelve (12) months of Study completion, Sponsor may post the results of the Study to a clinical research trial results web site in the form of a Clinical Research Study Report Synopsis in ICH-E-3 format, if applicable. Subject to the terms of this Agreement, UMC, through the Principal Investigator, shall have the right to publish the results of the research and any background information provided by Sponsor that is necessary to include in any publication of research results or necessary for other scholars to verify such research results. Principal Investigator will include a statement that creation of the Data was supported in part by Sponsor. Prior to submission for any public disclosure of the Data or results generated in accordance with this Agreement, including but not limited to disclosure of manuscripts, abstracts, posters and other materials (hereinafter, “Publication”), UMC will ensure that the Principal Investigator provides Sponsor with at least sixty (60) days for review of the Publication. Upon request, Sponsor and Institution will arrange expedited reviews for abstracts, poster presentations or other materials as appropriate. Notwithstanding the foregoing, no Publication that incorporates Sponsor Confidential Information will be submitted for publication without Sponsor’s prior written consent. If requested in writing UMC will ensure that the Principal Investigator withholds such Publication for up to an additional sixty (60) days to allow for filing of a patent application. Institution warrants the compliance of all investigators and other personnel involved with the Study with the provisions of this paragraph. If a particular Study is part of a multicenter study, the Institution agrees that the first Publication of the results of such Study shall be made as a joint, multicenter Publication of the Study results, with investigators and institutions from all participating sites contributing data. However, if such a multicenter Publication is not submitted within eighteen (18) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there will be no multicenter Study Publication, the Institution, through the Principal Investigator, may publish the results from the Institution site individually in accordance with this paragraph.

Comment [SL[1]: 01/05/16: Sponsor cannot accept the removal of this language. What is site’s rationale for removing this language?A call may be quicker to resolve any remaining open items.


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If Principal Investigator is invited to participate as an author of a manuscript for publication, Principal Investigator shall meet the criteria established by International Committee of Medical Journal Editors ("ICMJE") guidelines and shall have opportunity to guide, review, and modify the scientific manuscript throughout the development process. As an author, Principal Investigator shall help ensure that the scientific manuscript is objective and unbiased. Moreover, the final version of the scientific manuscript shall include a disclosure of Sponsor's involvement in the preparation of the scientific manuscript, consistent with the ICMJE guidelines.

If Principal Investigator is not chosen as author, then Institution shall ensure that he or she grants permission to be acknowledged in a Publication as contributing to the Data collection for the study. If Principal Investigator does not wish his or her name to appear as part of the acknowledgments, he/she shall submit this request in writing to Sponsor.

E. Registration and Related Information. Prior to the initiation of enrollment, Sponsor shall have the right to register and provide any information that is: (i) required to be registered by Sponsor pursuant to and in accordance with the Food and Drug Administration Amendments Act (42 U.S.C. § 282) or any other applicable laws and regulations; (ii) required by the ICMJE for studies intended to be published in the international peer-reviewed literature (http://www.icmje.org); or (iii) from company sponsored trials of both investigational and marketed medicines and products that are adequately-designed and well-controlled (21 CFR 314.126), whether or not required by (i) or (ii) of this section above. Registration will, at a minimum, be to the United States National Library of Medicine website designed for this purpose at www.clinicaltrials.gov. For subjects screened as potentially eligible in the Institution's geographical area, Institutions will receive a report with the completed screen and the subject's contact information. UMC agrees to follow-up on the report and to document such follow-up in source records.

5. Patents. All rights to any discovery or invention, whether patentable or not, conceived and/or reduced

to practice as a result of the work conducted under this Agreement (an “Invention”) shall belong to Sponsor. UMC and Principal Investigator hereby assign (and shall cause all Study investigators and other personnel involved with the Study to assign) to Sponsor or its designee, the sole and exclusive ownership of all Inventions. Sponsor shall have the sole right, but not the obligation, to file, prosecute and enforce any patents related to any Invention. UMC and Principal Investigator shall promptly disclose to Sponsor any Invention. UMC and Principal Investigator shall execute, and shall have all Study investigators and other personnel involved with the Study execute, all documents necessary to transfer all right, title and interest in and to any Invention or discovery to Sponsor. UMC warrants that Principal Investigator and all others performing services under this Agreement are employees or agents of UMC and are obligated to assign to Institution all inventions made in the course of their employment or agency, either by written agreement or by the terms of their employment. Nothing set forth in this Agreement shall affect the ownership or any right, title, or interest in any inventions, any patents and patent applications related to any inventions that exist on the Effective Date.

6. Reporting of Data.

A. Case Report Forms. Institution agrees to provide Sponsor periodically and in a timely manner

during the term of this Agreement with the Data called for in the Protocol on properly completed case report forms (the “CRF”). Case report forms shall be submitted pursuant to the Protocol and as follows: Institution agrees to provide Sponsor a facsimile (fax) copy of the following CRF pages within twenty-four (24) hours of conditions for each page having been met: Front page (screening), randomization page, DNA page, and Trial Termination page. All original case report forms should be sent via courier to Sponsor on a visit-by-visit basis, no later than five (5) days after visit procedures have been completed. When queries of CRF data are warranted, Institution also agrees to resolve and return, via fax, each Data Correction Form (DCF) within five (5) days of DCF


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receipt.

B. Electronic Data Capture (“EDC). In the event an EDC system is used for data entry and reporting, Sponsor warrants to Institution that the system complies with U.S. 21 C.F.R. Part 11 and the Health Insurance Portability and Accountability Act (the “HIPAA”). Institution will comply with Sponsor’s instructions, U.S. 21 C.F.R. Part 11, and HIPAA. Institution will prevent unauthorized access to the data by maintaining physical security of the computers and ensuring that personnel maintain the confidentiality of their passwords. Institution shall also comply with Sponsor’s instructions for Data entry into the system, which includes certifying to the Federal Food and Drug Administration (“FDA”) that Institution personnel using the system understand that their electronic signatures are the legally binding equivalent of handwritten signatures, and they attest to the accuracy and completeness of the Data entered.

Institution agrees to collect all Data in source documents prior to entering it into the electronic Case Report Form (“eCRF”), which shall be completed within seventy-two (72) hours of the subject’s visit, unless otherwise specified in the Protocol. Institution also agrees to provide appropriate responses to queries received within five (5) days of receipt, unless otherwise specified in the Protocol.

In the event that UMC is using a an electronic medical record including an Electronic Medical Record “EMR” or Electronic Health Record "EHR" system to collect source data/documents, UMC shall ensure that for all source documents located in the EMR/EHR system, a certified copy exists with a dated signature consistent with the FDA guidance Computerized Systems Used in Clinical Investigations, which states that the dated signature shall represent that the certified copy has "all of the same attributes and information as the original". This requirement may be waived if the Institution warrants 21 CFR Part 11 compliance of its source database. By accepting the waiver of this requirement, UMC agrees to ensure access to the EMR/EHR source records and documentation supporting 21 CFR Part 11 compliance, during and after the term of this Agreement, by Sponsor representatives and/or FDA or other government entities for auditing purposes, in accordance with Inspections/Audits Section of this Agreement.

C. Timely Data Submissions and Query Responses. Timely, accurate and complete Data submission

and query responses in accordance with this Section 6 are necessary to ensure payment in accordance with the Payment Schedule, Exhibit B of this Agreement.

D. Adverse Experience Reporting. Institution shall notify Sponsor within twenty-four (24) hours after learning of any serious and/or unexpected adverse drug experience (as defined in the Protocol) affecting any subject in the Study. Institution shall follow up such notification with appropriate reports in compliance with all applicable legal and regulatory requirements.

E. Use of Sponsor Laptops for EDC. In the event that UMC receives a laptop computer from Sponsor for EDC use, UMC shall be responsible for operating and maintaining the computer in a secure location within UMC, and for promptly reporting any technical issues preventing use of the computer, or EDC system, to the EDC helpdesk number that shall be provided by Sponsor. UMC agrees that the computer shall be used for the sole purpose of capturing the Sponsor’s electronic Data for the agreed study(s).

F. Use of UMC Laptop for EDC. In the event that UMC is using its own computer(s) to connect to and access the EDC system, UMC shall be responsible for supporting and promptly resolving any technical issues with UMC’s own computing environment (i.e., computer hardware, non-study related software). UMC shall be responsible for reporting any technical issues preventing use of the EDC system, that appear to be outside the scope of its own computing environment, to the EDC helpdesk number that shall be provided by Sponsor with the EDC system. UMC shall be responsible for obtaining Internet connectivity prior to Study initiation, and promptly resolving any connectivity issues with the internet service provider or own computing environment.


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7. Monitoring of Study.

A. Inspections/Audits. During and after the term of this Agreement, UMC agrees to permit

representatives of Sponsor and/or the FDA or other appropriate governmental authorities to examine at any reasonable time during normal business hours (a) the facilities where the Study is being conducted, (b) raw Study data including original subject records, and (c) any other relevant information (and to make copies) necessary for Sponsor to confirm that the Study is being conducted in conformance with the Protocol and in compliance with applicable FDA, Drug Enforcement Administration (DEA) or any national or governmental laws and regulations and the International Conference on Harmonisation (ICH) guidelines. UMC shall immediately notify Sponsor if any governmental authority schedules or without scheduling begins an inspection and shall promptly, upon issuance, provide Sponsor a copy of any governmental correspondence resulting from any such inspection.

B. Corrective Action. UMC and Principal Investigator agree to take all reasonable actions requested by Sponsor to cure deficiencies noted during an audit or inspection. In addition, Sponsor shall have the right to review and approve any correspondence to a governmental authority generated as a result of an inspection or audit prior to submission by UMC.

8. Compliance with Applicable Laws.

A. FDA and DEA Laws. Institution agrees to conduct the Study and maintain records and Data during

and after the term of this Agreement in compliance with the Protocol and all applicable legal and regulatory requirements, including without limitation, any applicable requirements of the FDA and the DEA.

B. Privacy Laws. (i) The parties agree that Institution’s use and disclosure of subject health and medical

information is subject to compliance with applicable state and federal privacy laws, as well as applicable European Union (EU) and national privacy and security laws and regulations. The parties, therefore, agree to take all reasonable steps to protect the confidentiality of any subject health and medical information that it has access to and comply with applicable state and federal privacy laws.

(ii) UMC agrees to obtain or cause Principal Investigator to obtain from each subject participating in the Study an appropriately signed informed consent form as noted above in Section 3(B) and a HIPAA Authorization as required by 45 C.F.R. Part 164.

(iii) UMC shall ensure that Sponsor may add Data collected under the Protocol to its research databases so that it, and/or its development partner(s) with regard to the Study Drug, may conduct additional reviews of the Data in order to study the safety and effectiveness of the Study Drug and other products and treatments, to develop a better understanding of disease, or to improve the efficiency of future clinical trials (collectively referred to as “further research uses”). Institution shall obtain an informed consent document signed by each subject in the study that addresses such further research uses. In addition, Institution hereby enters into a “Data Use Agreement” with Sponsor as set forth in Exhibit C, the Data Use Agreement, so that Data collected under the Protocol is disclosed to Sponsor in the form of a “Limited Data Set,” as these terms are defined by the Health Insurance Portability and Accountability Act of 1996, 45 C.F.R. Parts 160 and 164, (the “HIPAA privacy regulations”). Sponsor shall treat such Data in the Limited Data Set as protected health information, as defined in the HIPAA privacy regulations, and as described in the Data Use Agreement attached herein as Exhibit C.

C. Bayh-Dole Act. UMC represents and warrants that the performance of services pursuant to the

protocol under the terms of this Agreement is not subject to a funding agreement under 35 U.S.C. 201-212. Should this provision be breached, UMC hereby grants to Sponsor an irrevocable,


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worldwide, paid up, royalty-free, non-exclusive, license with the right sub-license, to make, to have made, use, have used, sell have sold and import any inventions which would have been owned by Sponsor pursuant to Section 5 of this Agreement, but for the breach of this provision in addition to any other rights Sponsor may have due to this breach.

D. Healthcare Compliance. The parties to this Agreement specifically intend to comply with all applicable laws, rules and regulations, including the federal anti-kickback statute (42 U.S.C. 1320a-7b), the related safe harbor regulations and the Limitation on Certain Physician Referrals, also referred to as the “Stark Law” (42 U.S.C. 1395 (n)). Accordingly, no part of any consideration paid hereunder is a prohibited payment for the recommending or arranging for the referral of business or the ordering of items or services; nor are the payments intended to induce illegal referrals of business. Nothing contained in this Agreement shall be construed in any manner as an obligation or inducement for the Institution or Principal Investigator to recommend that any person or entity purchase Sponsor’s products or those of any entity affiliated with Sponsor.

E. Noncompliance. In the event that any part of this Agreement is determined to violate federal, state, or local laws, rules, or regulations, the parties agree to negotiate in good faith revisions to the provision or provisions that are in violation. In the event the parties are unable to agree to new or modified terms as required to bring the entire Agreement into compliance, either party may terminate this Agreement on sixty (60) days written notice to the other party and the relevant provisions in the Term and Termination Section of this Agreement will apply.

F. Principal Investigator Notice. UMC shall inform the Principal Investigator and any personnel performing services under this Agreement, that Sponsor may collect the following personal identifying information: name, hospital or clinic address and phone number, and curriculum vitae, and may transfer this information to Sponsor’s affiliates and their respective agents worldwide for internal study management purposes. Nonetheless, Sponsor and its affiliates and agents will apply adequate privacy safeguards to protect such information. Sponsor, its affiliates, its agents and business partners may also use and disclose personal information as required by individual regulatory agencies or applicable law, such as to report serious adverse events. Upon written request, Sponsor will provide any individual performing services under this Agreement with reasonable access to his or her personal information that is held by Sponsor. Such individual may also request correction of information that he or she demonstrates to be inaccurate or incomplete.

G. Compliance With Third Party Health Insurance Programs. It is UMC's policy to conduct activities in accordance with applicable state and federal laws and regulations regarding Medicare, Medicaid, and other third party payer programs. Therefore, UMC certifies that:

(i) Neither it nor any of its affiliates providing services pursuant to this Agreement is

excluded from participation in any state or federal healthcare program, as defined in 42 USC Section 1320a-7b(f) for the provision of items or services for which payment may be made by a federal healthcare program;

(ii) It has not contracted for the performance of any services or supplies required for the performance of this Agreement with any employee, contractor, agent, vendor or vendor's affiliate, knowing that the contracting party is excluded from participation in any state or federal healthcare program; and

(iii) No final adverse action, as defined in 42 USC Section 1320a-7e(g)(1) and 42 USC Section 1320a-7a(g), has occurred or is pending against it or its affiliates or contractors providing services pursuant to this Agreement.

By signing this Agreement, UMC agrees to notify Sponsor of any final adverse action, discovery of contract with an excluded entity or individual, or exclusion (as defined above) within thirty (30) days of such action.

H. No Participation of Excluded/ Debarred Persons in Performance of this Agreement. Institution shall DRAFT 39039039APE4001 Janssen Scientific Affairs, LLC University Medical Center of Southern Nevada – Dr. David Slattery January 5, 2015

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not employ, contract with or retain any person directly or indirectly to perform services under this Agreement if such a person is

a. excluded from a Federal health care program as outlined in Sections 1128 and 1156 of

the Social Security Act (see the Office of Inspector General of the Department of Health and Human Services List of Excluded Individuals/Entities at https://oig.hhs.gov/exclusions/exclusions_list.asp;

b. debarred by the FDA under 21 U.S.C. 335a (see the FDA Office of Regulatory Affairs Debarment List at http://www.fda.gov/ICECI/EnforcementActions/FDADebarmentList/default.htm; or

c. excluded from contracting with the federal government (see the Excluded Parties Listing System at https://www.sam.gov/portal/public/SAM#1

Upon written request from Sponsor, Institution shall, within ten (10) days, provide written confirmation that it has complied with the foregoing obligation. In the event that Institution becomes aware that any person identified above becomes excluded or debarred or receives notice of the threat of an action with respect to such exclusion or debarment, Institution shall promptly provide Sponsor with notice. Upon receipt of such notice, Sponsor shall have the right to terminate this Agreement immediately.

I. Representations and Warranties: Conflict of Interest Obligations. (i) Where the research funding under this Agreement is subject to professional and/or

employment rules (such as conflicts of interest or ethics policies) established by UMC or a professional organization or other institution with which the Principal Investigator or other investigator(s) are affiliated, UMC shall cause Principal Investigator and other investigator(s) to warrant that he or she shall comply fully with such rules, including, as applicable, obtaining any required approval(s) prior to initiating the research and making any required reports. Further, UMC and Principal Investigator have received no offer by Sponsor or its affiliates or agents of extra benefit for participation in the Study, including offers to family members. UMC will promptly notify Sponsor if any conflict of interest arises during the term of this Agreement. Neither Institution nor any investigator performing services under this Agreement shall enter into a financial security transaction based on Data or results. UMC warrants that it has policies and procedures with respect to conflicts of interest and will promptly report to the Sponsor any such conflicts relating to the Principal Investigator or any other investigator(s) duties under this Agreement.

(ii) UMC shall also provide all information to Sponsor necessary to comply with any disclosure requirements mandated by the FDA, including any information required to be disclosed in connection with any financial relationship between Sponsor and Principal Investigator and any other Investigator involved in the Study and any other agent or employee of Institution and Sponsor. This disclosure requirement may require disclosure of information involving immediate family members of those involved in the Study.

(iii) UMC represents and warrants that it is under no agreement or obligation to any third

party and has no material conflict of interest that would prevent it from performing its duties and obligations under this Agreement.

(iv) Principal Investigator Representations and Warranties:

a. The execution, delivery, and performance of this Agreement by Principal

Investigator shall not conflict with, breach, cause a default under, or result in the termination of any contract, employment relationship, grant or funding, agreement


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or understanding, oral or written, with any third party, including without limitation any noncompetition covenant to which Principal Investigator is a party or by which Principal Investigator is bound. The Principal Investigator further represents and warrants that neither he/she nor UMC personnel involved in the conduct of the Study have any obligation, whether express or implied, to any third party that would interfere with, hamper or limit its ability to provide the services or to comply with any other obligations under this Agreement.

b. If Principal Investigator is a government employee, he/she shall comply with applicable government ethics rules and has secured any necessary approval of an appropriate ethics officer, relevant state or federal legal authority and, as necessary, supervisor, to enter into this agreement.

c. If Principal Investigator is a member of a pharmacy and therapeutics committee ("P&T Committee") of a health plan, pharmacy benefit manager or other health care provider or payor, whether public or private, he/she represents and warrants compliance with applicable ethics rules of his/her P&T Committee, including standards for conflict of interest, disclosure and recusal, and that he/she has secured any necessary approval of an appropriate ethics officer to enter into this agreement.

9. Indemnification.

A. Sponsor’s Obligation. Sponsor shall indemnify, defend, and hold harmless Principal Investigator,

InstitutionUMC, its trustees, officers, agents, and employees and Principal Investigator (“Indemnitees”) from any and all losses, costs, expenses, liabilities, claims, actions and damages (collectively referred to as “Claims”) based on a personal injury to a subject directly or indirectly caused by use of the Study Drug during the course of the Study.

B. Exceptions. The above obligation of Sponsor shall not apply and Sponsor shall not be liable for any indemnification or expenses for Claims in any way arising from or caused by the willful, reckless, or negligent acts or omissions, or professional malpractice of the Indemnitees, or arising from or caused by any of their failures to comply with the Protocol, with Sponsor’s written recommendations and instructions relative to the use of the Study Drug, or with any applicable FDA or other governmental requirements or law.

B.C. Principal Investigator’s Obligations. Principal Investigator agrees to defend and indemnify Sponsor and UMC, and hold them harmless from and against any liability, claim, loss, damages and expenses (including attorney’s fees and cost of suit) (collectively “Losses”) incurred by them in connection with any and all suits, investigations, claims or demands made or brought by or on behalf of third parties against UMC or Sponsor, to the extent arising out of or relating to Principal Investigator’s negligence, willful misconduct or wrongful act or omission relating to the Protocol or otherwise in connection with performance of the Study.Principal Investigator shall indemnify and hold harmless Sponsor and UMC for Claims in any way arising from or caused by the willful, reckless, negligent acts or omissions, or professional malpractice of the Principal Investigator, or arising from or caused by any of the Principal Investigator’s failures to comply with the Protocol, with Sponsor’s written recommendations and instructions relative to the use of the Study Drug, or with any applicable FDA or other governmental requirements of law.

CD. Indemnitees’ Obligations. The obligation of the indemnifying party hereunder shall apply only if the other party provides prompt notification upon receipt of notice of any claim or suit, permits the indemnifying party and its attorneys and personnel to handle and control the defense of such claims or suits, including pretrial, trial or settlement, and the indemnified party fully cooperates and assists in such defense. The indemnified party further agrees that it will not settle or compromise any such claim or suit without the prior written consent of the indemnifying party.

10. Insurance. Principal Investigator shall secure and maintain in full force and effect through the

Comment [SL[2]: 01/05/16: Sponsor can accept as modified by Sponsor.

Comment [SL[3]: 01/05/16: Sponsor can accept as modified by Sponsor. Language reads more similiarly in style to with the rest of the paragraph and retained Claims as the defined termed throughout the Indemnification provision. Removed losses as a defined term. Language as written should addresses site’s concerns.


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performance of the Study (and following termination of the Study to cover any claims arising from the Study) insurance coverage for: (i) medical professional and/or medical malpractice liability; (ii) general liability; and (iii) workmen’s compensation, each such insurance coverage in amounts appropriate to the conduct Principal Investigator’s business activities and the services contemplated by the Study, but in no event shall the amounts for medical professional, medical malpractice, and general liability be less than $2,000,000 per occurrence and $5,000,000 in aggregate. UMC is owned and operated by Clark County pursuant to the provisions of Chapter 450 of the Nevada Revised Statutes. Clark County is a political subdivision of the State of Nevada. As such, Clark County and UMC are protected by the limited waiver of sovereign immunity contained in Chapter 41 of the Nevada Revised Statutes. UMC is self-insured as allowed by Chapter 41 of the Nevada Revised Statutes. Upon request, UMC will provide Sponsor with a Certificate of Coverage prepared by its Risk Management Department certifying such self coverage. The failure of Institution or Principal Investigator to secure and maintain appropriate coverage shall in no way limits the liability of that party.

11. Payment.

A. Budget and Compensation. The compensation and fees to be paid by Sponsor for the Study is contained in the budget described in Exhibit B, attached hereto and incorporated by reference in this Agreement. Payment shall be due and payable in accordance with the schedule set forth in Exhibit B.

B. Fair Market Value. The parties acknowledge and agree that the compensation and support provided by Sponsor to UMC pursuant to this Agreement represents the fair market value for the research services conducted by Institution, has been negotiated in an arms-length transaction, and has not been determined in a manner that takes into account the volume or value of any referrals or other business otherwise generated between Sponsor and UMC.

C. Investigator Meetings. Sponsor may recommend or obligate the Principal Investigator and a Study nurse/coordinator to attend meetings, including but not limited to an Investigator’s Meeting. Sponsor shall provide and pay all reasonable and appropriate travel expenses, including modest lodging and meals associated with such meetings in accordance with Sponsor’s travel and expense policy attached hereto as Exhibit D. Both parties agree that attending such meetings is reasonable and necessary to ensure all parties engaged in the Study have a clear understanding of the Protocol and its requirements.

D. Third Party Payor Billing. Neither UMC nor Principal Investigator shall bill any third party for Study Drug or any other items or services furnished by Sponsor in connection with the Study, or any services provided to subjects in connection with the Study for which payment is made as part of the Study.

12. Independent Contractor. UMC and Principal Investigator are acting in the capacity of independent

contractors hereunder and not as employees or agents of Sponsor. Neither party shall make any claim against the other for compensation, vacation pay, sick leave, retirement benefits, social security benefits, workers’ compensation, disability or unemployment benefits or employee benefits of any kind.

13. Publicity. No party shall use the name of any other party, for promotional purposes without the prior written consent of the party whose name is proposed to be used except as required by law.

14. Controlling Law. This Agreement shall be governed by and construed in accordance with the laws of

the State of Nevada without regard to any conflicts of laws provisions.

15. Notice. Any notices given hereunder shall be deposited in the United States mail, postage prepaid, DRAFT 39039039APE4001 Janssen Scientific Affairs, LLC University Medical Center of Southern Nevada – Dr. David Slattery January 5, 2015

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personally delivered or recognized courier service, as follows:

TO SPONSOR: Janssen Scientific Affairs, LLC Peter Wildgoose

1000 Route 202 PO Box 300 Raritan, NJ 08869

COPY TO: Janssen Research & Development, L.L.C. Chase Coalter, Director, Contracts & Grants

1125 Trenton-Harbourton Road Titusville, NJ 08560 Facsimile: 609-730-6689

TO UMC: University Medical Center of Southern Nevada Attn: CEO 1800 W. Charleston Blvd. Las Vegas, NV 89102 TO PRINCIPAL INVESTIGATOR: David Slattery, MD 109 Rancho Lane, Ste. 135 Las Vegas, NV 89106

16. Force Majeure. If the performance of this Agreement by Institution or Sponsor is prevented, restricted,

interfered with or delayed, (either totally or in part) by reason of any cause beyond the reasonable control of the parties (such as acts of God, explosion, disease, weather, war, terrorism, insurrection, civil strike, riots or power failure), the party so affected shall, upon giving written notice to the other party, be excused from such performance to the extent of such prevention, restriction, interference or delay, provided that the affected party shall use its reasonable best efforts to avoid or remove such causes of non-performance and shall continue performance with the utmost dispatch whenever such causes are removed. For purposes of this section, a lack of funds shall not be considered a cause beyond the reasonable control of the parties.

17. Agreement Modifications. This Agreement, or any of its exhibits, may not be altered, amended or

modified except by written document signed by all parties hereto.

18. Assignment. Sponsor shall have the right to assign this Agreement to an affiliate of Sponsor or any other third party who has or acquires during the term of this Agreement an interest in the Study Drug. In all other instances, neither party shall assign its rights or duties under this Agreement to another without prior written consent of the other party, provided such consent shall not be unreasonably withheld or delayed. Subject to the foregoing, this Agreement shall bind and inure to the benefit of the respective parties and their successors and assigns.

19. Conflict with Protocol. If a provisions of this Agreement conflicts with a provision of the Protocol, the

Protocol takes precedence on matters of medicine, science and conduct of the Study. This Agreement takes precedence in any other conflicts.

20. Dispute Resolution.

The parties recognize that a dispute may arise relating to this Agreement ("Dispute"). Any Dispute, including Disputes that may involve the parent company, subsidiaries, or affiliates under common


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control of any party, shall be resolved in accordance with this Section of the Agreement.

A. Mediation. The parties shall first attempt in good faith to resolve any Dispute by confidential mediation in accordance with the then current Mediation Procedure of the International Institute for Conflict Prevention and Resolution ("CPR Mediation Procedure") (www.cpradr.org) before initiating litigation. The CPR Mediation Procedure shall control, except where it conflicts with these provisions, in which case these provisions control. The mediator shall be chosen pursuant to CPR Mediation Procedure. The mediation shall be held in Las Vegas, Nevada. Either party may initiate mediation by written notice to the other party of the existence of a Dispute. The parties agree to select a mediator within 20 days of the notice and the mediation will begin promptly after the selection. The mediation will continue until the mediator, or either party, declares in writing, no sooner than after the conclusion of one full day of a substantive mediation conference attended on behalf of each party by a senior business person with authority to resolve the Dispute, that the Dispute cannot be resolved by mediation. In no event, however, shall mediation continue more than 60 days from initial notice by a party to initiate meditation unless the parties agree in writing to extend that period. Any period of limitations that would otherwise expire between the initiation of mediation and its conclusion shall be extended until 20 days after the conclusion of the mediation. Either party has the right to seek from the appropriate court provisional remedies such as attachment, preliminary injunction, replevin, etc. to avoid irreparable harm, maintain the status quo, or preserve the subject matter of the Dispute.

B. Litigation. If the parties fail to resolve the Dispute in mediation, and a party desires to pursue resolution of the Dispute, the Dispute shall be submitted by either party for resolution by a judge sitting without a jury in the Eighth Judicial District Court of the State of Nevada. The parties agree to seek an early conference with the court and to advise the court of this Agreement. The parties agree to make all filings required by the court on a schedule that will assure trial ready status as promptly as possible after the service of the first complaint and further agree to make all motions, including motions for summary judgment, on a schedule that will allow them to be fully considered by the court less than one (1) year after service of the first complaint. Allparties agree to conduct discovery in a manner and on a schedule to assure completion of discovery as promptly as possible after service of the first complaint. To that end, each of the parties hereto agrees to pursue no more than the following discovery in the aggregate from all parties and non-parties to the action: a total of no more than 20 requests for documents (including subparts); a total of no more than 20 interrogatories (including subparts); and a total of no more than 40 hours of deposition testimony from all witnesses in the aggregate, including both fact and expert witnesses. The parties agree to work together to reach agreement to limit discovery of electronically stored information, including the use of date restrictions and file types. To obtain email, parties must propound specific email production requests directed to specific issues, rather than general discovery. Email production requests shall identify the custodian, search terms, and time frame and be limited to a total of five custodians and five search terms. EACH PARTY HERETO WAIVES: (1) ITS RIGHT TO TRIAL OF ANY ISSUE BY JURY, (2) WITH THE EXCEPTION OF RELIEF MANDATED BY STATUTE, ANY CLAIM TO PUNITIVE, EXEMPLARY, MULTIPLIED, INDIRECT, CONSEQUENTIAL OR LOST PROFITS/REVENUES DAMAGES, AND (3) ANY CLAIM FOR ATTORNEY FEES, COSTS AND PREJUDGMENT INTEREST.

21. Waiver and Severability. No waiver by any party of any breach of any provision hereof shall constitute a waiver of any other breach of that or of any other provision hereof. In the event that a court of


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competent jurisdiction holds any provision of this Agreement to be invalid, such holding shall have no effect on the remaining provisions of this Agreement, and they shall continue in full force and effect.

22. Survival. The following provisions and any other term or condition which by its nature is clearly intended to survive the termination or expiration of this Agreement will survive the termination or expiration of this Agreement: 1G, 2D, 4, 5, 6, 7, 8, 9, 10, 13, 14, 15,18, 20, 21, 22, 23, 24, 25 and 26.

23. Warranty. UMC and Principal Investigator understand and agree that Sponsor makes no warranty,

either expressed or implied, regarding the use of the product in the Study. Without limiting the foregoing, Sponsor expressly disclaims any implied warranties of merchantability or fitness for a particular purpose.

24. Disclosure of Compensation. The parties acknowledge that the Physician Payments Transparency

Requirements of the Patient Protection and Affordable Care Act of 2010 (codified at 42 U.S.C. 1320a-7h) and implementing regulations, require certain pharmaceutical, medical device, and other companies to annually report to the Centers for Medicare and Medicaid Services (CMS) certain information about payments and transfers of value provided directly or indirectly to U.S. physicians and teaching hospitals, which CMS will make publicly available. This includes any payments or transfers of value that Sponsor provides indirectly through UMC to U.S. physicians and teaching hospitals. As required by law, Sponsor will report to CMS information about payments and transfers of value that UMC provides to U.S. physicians and teaching hospitals pursuant to this Agreement. This includes any portion of any payment or transfer of value that Sponsor furnishes to Institution which UMC then provides directly or indirectly to U.S. physicians or teaching hospitals, including its employees, agents, or contractors. Information that Sponsor must report includes the identity and business address of each relevant U.S. physician or teaching hospital, the value and purpose of any payments or transfers of value that are furnished, and any other information as may be required by law. To enable Sponsor to comply with its legal obligations, UMC shall track, maintain, and provide Sponsor information and data related to any payments or transfers of value that Institution provides to U.S. physicians and teaching hospitals under this Agreement. UMC shall provide such information and data in the form and manner that Sponsor requests in a timely manner. The Sponsor may also report information about compensation, payments or transfers of value that UMC provides to U.S. physicians and teaching hospitals as otherwise required by law and the Sponsor reserves the right to post on a website accessible to the public such information, whether or not required by law.

25. Headings. Headings used in this Agreement are for the purpose of convenience only and do not affect the interpretation or construction of the Agreement itself.

26. Entire Agreement. It is the mutual desire and intent of the parties to provide certainty as to their

respective future rights and remedies against each other by defining the extent of their mutual undertakings as provided herein. Accordingly, this Agreement (i) supersedes all previous understandings, agreements and representations between the parties, written or oral and (ii) constitutes the entire agreement and understanding between the parties with respect to the subject matter thereof and incorporates all representations, warranties, covenants, commitments and understandings on which they have relied in entering into this Agreement, and, except as provided for herein, neither party makes any covenant or other commitment concerning its future action nor does either party make any promises, representations, conditions, provisions or terms related thereto.

27. Authorized Representatives. Each signatory to this Agreement personally represents that, he/she has

authority to legally bind his/her respective party to this Agreement.

28. Counterparts. This Agreement may be executed in counterparts, each of which shall be an original and all such counterparts together shall constitute the entire Agreement. Electronically transmitted and facsimile transmitted signatures shall have the full force and effect of an original signature.


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29. Budget Act and Fiscal Fund Out. In accordance with the Nevada Revised Statutes (NRS 354.626), the financial obligations under this Agreement between the parties shall not exceed those monies appropriated and approved by UMC for the then current fiscal year under the Local Government Budget Act. This Agreement shall terminate and UMC's obligations under it shall be extinguished at the end of any of UMC's fiscal years in which UMC’s governing body fails to appropriate monies for the ensuing fiscal year sufficient for the payment of all amounts which could then become due under this Agreement. UMC agrees that this section shall not be utilized as a subterfuge or in a discriminatory fashion as it relates to this Agreement. In the event this section is invoked, this Agreement will expire on the 30th day of June of the current fiscal year. Termination under this section shall not relieve UMC of its obligations incurred through the 30th day of June of the fiscal year for which monies were appropriated.

[Signatures follow on the next page.]


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IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed by their duly authorized representatives. Janssen Scientific Affairs, LLC Signature_______________________________ Date___________________ Charles Coalter Director, Contracts & Grants University Medical Center of Southern Nevada Signature_______________________________ Date____________________ Mason VanHouweling CEO David Slattery, MD Signature_______________________________ Date____________________ Dr. David Slattery Principal Investigator Attachments: Exhibit A: Protocol by reference Exhibit B: Budget and Payment Schedule Exhibit C: Data Use Agreement Exhibit D: Johnson & Johnson Travel & Expense Policy


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Exhibit A

Protocol by reference only; (page intentionally left blank).


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Exhibit B

Budget and Payment Schedule

Protocol No. 39039039APE4001: “MulticEnter trial of Rivaroxaban for early disCharge of pUlmonaRY embolism from the Emergency Department (MERCURY PE)”

(1) Maximum Enrollment Fee Per Completed Subject (including all fixed costs and excluding

invoiceables as specified in Term (2) Other Compensation, below): US$3,887.00 (2) Other Compensation:

Local Ethics Committee Fees: Local Ethics Committee (EC/IRB) fees shall be

reimbursed. Processing of payment will begin upon receipt of original invoice or alternative supporting documentation, detailing actual charges without markup. SPONSOR WILL NOT PAY LOCAL IRB DIRECTLY.

Start-Up Payment: A non-refundable payment of US$3,500.00 for start-up related activities (e.g. preparation of regulatory documents, preparation, administration, and submission of protocol and related documents to the Institutional Review Board (IRB), etc.) will be made upon execution of the Clinical Trial Agreement. This payment is considered full and final compensation for all activities associated with study initiation.

Pharmacy Set-up Fee: A one-time, non-refundable Pharmacy Set-up Fee of US$1,300.00

will be paid to UMC upon receipt of invoice and approval of the Local Trial Manager. This payment is considered full and final compensation for all Study related start-up pharmacy costs incurred.

Clinical Trials Office Fee: A non-refundable payment of US$2,600.00 for Clinical Trial

Office administrative Study set-up related activities (e.g protocol review, regulatory document collection and filing, development of Prospective Reimbursement Analysis (PRA), study communications and budget preparation) will be made upon execution of the Clinical Trial Agreement. This payment is considered full and final compensation for all activities associated with study initiation.

Clinical Trials Office Amendment Fee: Sponsor will pay UMC US$975.00 per protocol

amendment in which UMC must make a change to billable items and/or services requiring a change to the Prospective Reimbursement Analysis (PRA). Payment will be made upon receipt of invoice from the UMC and approval of the Local Trial Manager.

Pharmacy Annual Maintenance Fee: An annual fee of US$1,560.00 will be paid to UMC

for each year the study drug is maintained at the pharmacy. The annual fee is based on a monthly fee of US$130.00 and will be invoiced annually and pro-rated based on number of months Study Drug is maintained at pharmacy. Payment will be made upon receipt of invoice and approval of the Local Trial Manager. This payment is compensation for all Study related maintenance based on costs incurred.

Pharmacy Close-out Fee: A one-time, non-refundable Pharmacy Close-out Fee of

US$390.00 will be paid to UMC upon completion of the close-out visit at UMC, receipt of invoice and approval of the Local Trial Manager. This payment is considered full and final compensation for all Study related close-out pharmacy costs incurred.

Record Retention/Document Storage Fees- Sponsor will pay UMC US$650.00 upon

completion of the Study for Record Retention/Document Storage Fees, upon the receipt of an invoice from UMC and approval of the Local Trial Manager.


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Screen Failure Payments: Sponsor shall reimburse UMC at a rate of US$1,929.20 with a

cap of 1 Screen Failure subject regardless of enrollment. After payment of 1 Screen Failure, 1 additional Screen Failure will be paid for every 5 subjects enrolled by the site. Payment will be made upon receipt of invoice detailing subject number and date of screen failure and approval of the Local Trial Manager.

Re-Consenting of Subject: UMC shall be reimbursed for pre-approved re-consenting of

subject if done during a regularly scheduled study visit at a rate of US$130.00. This fee covers the cost of consenting the subject. If done outside of a regularly scheduled study visit, UMC will be reimbursed at a rate of US$304.20 per subject. This fee covers the cost of consenting the subject, Principal Investigator and Study Coordinator fees and subject travel reimbursement. Processing of payment will begin upon receipt of invoice detailing subject number, date of reconsent, and approval by the Local Trial Manager.

Additional Urine Pregnancy Test: Reimbursement for Pregnancy Tests as indicated in the Time and Events Schedule of the Protocol are included in the Milestone Table below. Additional urine pregnancy tests performed as deemed necessary by the investigator or required by local regulations per the requirements of the Protocol will be reimbursed in the amount of US$50.70 per test. Processing of payment will begin upon receipt of invoice with adequate supporting documentation in accordance with Section 4 below, and approval of the Local Trial Manager.

Local Serum Pregnancy Test: UMC shall be reimbursed in the amount of US$106.60 for serum pregnancy tests performed as deemed necessary by the investigator or required by local regulations per the requirements of the Protocol but not specifically scheduled in the Time and Events Schedule. Processing of payment will begin upon receipt of invoice with adequate supporting documentation in accordance with Section 4 below, and approval of the Local Trial Manager.

Local Serum Creatinine Clearance: UMC shall be reimbursed US$105.30 for additional

local CrCl lab if needed due to an issue with the initial eligibility blood draw. Sample must be repeated on the day of screening, in accordance with the Protocol, to be reimbursed. Processing of payment will begin upon receipt of invoice with adequate supporting documentation in accordance with Section 4 below, and approval of the Local Trial Manager.

Local Troponin: UMC shall be reimbursed US$110.50 for additional local Troponin lab if

needed due to an issue with the initial eligibility blood draw. Sample must be repeated on the day of screening, in accordance with the Protocol, to be reimbursed. Processing of payment will begin upon receipt of invoice with adequate supporting documentation in accordance with Section 4 below, and approval of the Local Trial Manager.

Bed Fee: UMC shall be reimbursed an all-inclusive rate of US$1,129.70 per overnight bed

fee as deemed necessary by the investigator for hospitalization related to the study. There will be no bed fee reimbursement for the initial hospitalization for subjects randomized to the standard of care arm. No additional costs, including hospital overhead, staffing, meals, subject travel expenses, etc. will be reimbursed. Processing of payment will begin upon receipt of invoice with adequate supporting documentation in accordance with Section 4 below, and approval of the Local Trial Manager.

Adjudication Fee: US$585.00 per subject. UMC shall be reimbursed for the costs

involved with the preparation, review, and submission of adjudication packages, as appropriate. Processing of payment will begin upon receipt of invoice with adequate


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supporting documentation in accordance with Section 4 below, and approval of the Local Trial Manager.

Protocol Related Incidental Costs: Sponsor acknowledges that certain costs associated with the performance of the Study may not be known when the study budget/payment schedule is prepared. UMC may be reimbursed for actual costs incurred up to a maximum of US$500.00 for services provided in accordance with the conduct of the Study but not specifically outlined in the budget/payment schedule of this Agreement. UMC must request approval of these costs in advance to allow Sponsor to evaluate whether the activity is necessary to support the Study and the proposed costs represent fair market value for the services. Reimbursement for pre-approved costs will be made upon receipt of invoice with appropriate detail to support work performed, documentation of Sponsor’s pre-approval, and any other necessary supporting documentation and approval of the Local Trial Manager.

(3) Payment Milestones per Enrolled Subject:

The milestone payments represent fair market value for the performance of the research services detailed in the Time and Events Schedule of the Protocol dated June 16, 2015, provided herein by reference in Exhibit A. The parties agree that in the event subsequent protocol amendments result in a material change to the research services required, the compensation will be adjusted accordingly to represent any such change to the fair market value through a written amendment signed by all parties hereto.

MILESTONE

AMOUNT

(per enrolled subject)

Visit 1 (Screening / Randomization) US$1,929.20*

Phone Call, Follow up 1 US$130.00



Visit 2, Day 30 US$816.40*

Day 90, End of Study/Early Termination US$751.40*

TOTAL US$3,887.00* Biomarker Samples

(Only paid as completed by consented biomarker sample subjects.) US$273.00

Follow up 1, Inpatient (Only paid for subjects who remain inpatient at Day 3 (+ 1 day). Payment will reflect Phone call, Follow Up 1 amount + additional amount required for Inpatient visit for

the total listed here.

US$364.00

Follow up 2, Inpatient (Only paid for subjects who remain inpatient at Day 7 (+ 2 days). Payment will

reflect Phone call, Follow Up 2 amount + additional amount required for Inpatient visit for the total listed here.

US$382.20

Unscheduled Telephone Contact (Only paid for final vital status or follow up of a clinically relevant protocol-related event, subject discomfort, or impairment of activities of daily life. Will repeat as

needed.)

US$130.00

Unscheduled Visit (Only paid for protocol-related clinic visits, not routine care visits, in addition to

those outlined in the Visit Schedule. Will repeat as needed.) US$657.80*


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A subject stipend for the Study subjects in the amount of US$58.00 has been included in the cost associated with each scheduled visit, and has been incorporated into the payment for each visit listed on the payment schedule, above. This allowance is intended to offset the Study subject’s costs associated with travel expenses and meals, where appropriate, incurred as a result of Study participation, and shall be reflected in the Informed Consent Form, as it will be provided to the Study subject. (4) Payments Terms:

a) This EXHIBIT B is for completed records for up to 12 valid subjects. A valid subject is defined as a subject who meets eligibility requirements to enroll in the Study and does not have significant Protocol violations that would exclude his/her Data from analysis. This Study is being conducted under a policy of competitive enrollment. Sponsor anticipates closure of enrollment upon randomization of a total of 300 valid subjects. In the event that 300 total valid subjects are enrolled prior to a site’s reaching its valid subject goal of 12, further recruitment will be suspended. Subjects not completing the trial will be paid for on a prorated basis according to the number of confirmed completed visits and CRFs received by Sponsor. All payment will be made for subject visits according to the Payment Schedule above. No payment will be made for any subject excluded from analysis because of Protocol violations that were within the Study personnel’s control. Reimbursement for expenses related to screen failures will be made according to the Payment Schedule. b) UMC acknowledges that this is a multicenter Study designed to evaluate a set number of Study subjects. It is anticipated that each institution participating in the Study will enroll the number of Study subjects provided for under the Agreement. Additionally, as the Study progresses and individual institutions meet the contracted number of Study subjects, Sponsor may inviteUMC to enroll more Study subjects. If this is acceptable to UMC, Sponsor will notify UMC via written request to allow for the enrollment of additional Study subjects. UMC further acknowledges that it, therefore, may not have the opportunity to enroll the number of Study subjects set forth above. When enrollment of the target number of Study subjects in the Study is complete, those sites which have not enrolled the contracted number of Study subjects will be notified and instructed not to continue enrolling Study subjects.

c) Equipment Calibration: UMC shall be responsible for ensuring any UMC-owned equipment utilized by Institution in accordance with this Agreement, is serviced and/or calibrated as per manufacturer’s recommendation and/or more frequently as required by the Sponsor. Records verifying the equipment calibration and maintenance shall be provided to Sponsor upon request. For calibrations which are performed solely at the request of the Sponsor, and that are not part of the recommended scheduled maintenance suggested by manufacturer, Sponsor will reimburse UMC for the actual cost without mark-up for each calibration. Processing of payment will begin upon receipt of invoice and supporting documentation in accordance with Section 4 below and approval of the Local Trial Manager. d) Investigator Meetings: Sponsor may recommend or obligate the Principal Investigator and a Study nurse/coordinator to attend meetings, including but not limited to an Investigator’s Meeting. Sponsor shall provide and pay all reasonable and appropriate travel expenses, including modest lodging and meals associated with such meetings. The parties agree that attending such meetings is reasonable and necessary to ensure all parties engaged in the Study have a clear understanding of the Protocol and its requirements. e) To be eligible for payments, the procedures must be performed in full compliance with the Protocol and this Agreement, and Data submitted must be complete, correct and entered into the Electronic Data Capture (EDC) in accordance with Sponsor’s instructions and this Agreement. Payments will be made, at a minimum, on a quarterly basis. These payments will include milestone payments, as listed in the table above, as well as all invoiced and approved costs from the prior payment cycle. Ongoing reconciliations will be performed during the course of the study. Any


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erroneous payments discovered will be applied to any pending or future payments due. No payments will be made until all erroneous payments have been offset. If no pending or future payments exist, UMC will promptly refund overpayment, according to Sponsor’s instructions.

Original invoices pertaining to this study should be submitted for reimbursement to the following address: US C&G Invoice Mailbox ([email protected])

Please note that invoices must contain the following information or they will be returned, delaying payment: • Hospital name • Principal Investigator name • Protocol number • Invoice number and date • Date & description of services provided • Supporting documentation (i.e. third party invoices, receipts)

f) Costs from, and reimbursement for, activities and items not specifically referenced in Term (2) Other Compensation above, including but not limited to staff costs, laboratory fees, x-rays, worksheets (quality of life, etc.), data coordinator fees, travel fees, and subject reimbursement other than any subject stipends specifically identified above, are incorporated into the per-subject payment in accordance with Term (3) Payment Milestones, above. No additional reimbursement for these costs is otherwise provided.

g) For the avoidance of doubt, UMC is responsible for providing any and all compensation, benefits and/or insurance to the investigational staff. It is not also understood and expressly acknowledged that the Investigator and the investigational staff are not eligible to participate in, nor are they eligible for coverage under, any of the Sponsor’s benefit plans, programs, employment policies, procedures or workers compensation insurance.

h) The parties agree that this EXHIBIT B is part of the Agreement clarifying the payment schedule associated with this Agreement. Payments shall be made in accordance with the provisions set forth in this EXHIBIT B, with the last payment being made after the site completes all of its obligations under the Agreement and any exhibits thereto. The Principal Investigator acknowledges and agrees that his or her judgment with respect to his or her advice to and care of each subject is not affected by the compensation the site receives hereunder. The parties agree that the payee designated below is the proper payee for this Agreement, and that payments under this Agreement will be made only to the following payee:

PAYEE NAME: (Please note that his should be a business name and must match the business name used to file for your tax EIN or other tax ID number)


PAYEE ADDRESS: THIS CONTACT INFORMATION SHOULD BE THE PERSON TO WHICH DETAILED PAYMENT REMITTANCE INFORMATION (I.E. SUBJECT NUMBERS, VISITS COMPLETED, COMPLETION DATE AND INVOICE INFORMATION) SHOULD BE SENT.

Attn: Accounts Receivable

1800 W. Charleston Blvd.

Las Vegas, NV 89102

TAX ID NUMBER: (Tax ID must exactly match the payee name indicated above)

88-6000436


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UMC will have thirty (30) days from the Last Subject Out (LSO) date of the Study to resolve any payment discrepancies, which have arisen during the course of the Study.

CONTACT INFORMATION: (Name, phone #, e-mail address)

Ron Roemer [email protected] 702) 207-8345 (Ron) Andrea (Andi) Hermann [email protected] (702) 207-8272 (Andi)


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Exhibit C

Data Use Agreement

(a) Encoding study data. Institution shall ensure that the subject identifiable information that is disclosed on the case report form and provided to Sponsor under this Study meets criteria specified of a “limited data set, ” as defined in 45 C.F.R.§ 164.514(e), as part of the privacy rule issued pursuant to HIPAA Parts 160 and 164 (the “HIPAA Privacy Rule”).

(b) Sponsor use of data set. Sponsor shall use and disclose information in the limited data set for research purposes only, which may include the following:

• Reviewing the safety or effectiveness of the Study Drug or Study Product and other products or therapies;

• Conducting performance reviews of the product or retrospective reviews of the Study or the study data;

• Evaluating other products and therapies; • Developing a better understanding of disease; or • Improving the design and efficacy of future clinical research trials.

Sponsor shall not use or disclose information in the limited data set in any manner that would violate the requirements of the HIPAA Privacy Rule if done by Institution. Sponsor will limit access to the limited data set to personnel responsible for research and development functions within Sponsor’s organization or within affiliated companies controlling, under common control with, or controlled by, Sponsor. Sponsor may also provide access to contract research organizations, its development partner(s) with regard to the Study Drug, and other consultants or agents working with the research and development functions of these entities, on the research activities detailed above. Sponsor will ensure that all such parties assume the data protection responsibilities of Sponsor as set forth in paragraph (c).

(c) Protection of the limited dataset. Sponsor shall, with respect to the information contained in the limited data set: (i) not use or further disclose the information other than as permitted or required by this Agreement or as otherwise required by law; (ii) use appropriate safeguards to prevent use or disclosure of the information other than as provided for by this Agreement; (iii) report to Institution any use or disclosure of the information not provided for by this Agreement of which it becomes aware; (iv) ensure that any agent or assignee, including a subcontractor, to whom it provides the information agrees to the same restrictions and conditions that apply to Sponsor with respect to the limited data set; and (v) not identify the information or contact the individuals to whom it pertains.

(d) Right of termination. Institution shall have the right to terminate this data use agreement if it determines that Sponsor has violated a material term of provisions (a) through (c). However, Institution may not exercise its right of termination unless (i) it has provided Sponsor with an opportunity to cure the violation and Sponsor has failed to do so within sixty (60) days or (ii) a cure for the violation is not possible. Termination of the data use agreement shall not constitute a termination of this Agreement.


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EXHIBIT D JOHNSON & JOHNSON TRAVEL & EXPENSE POLICY

All business travel arrangements for air, lodging and car rental must be made through the approved on-line Johnson & Johnson reservation system, by American Express Business Travel, or American Express Business Travel’s approved Network Partner (hereafter referred as American Express). All company meetings, conferences, events and trips that require a hotel must be sourced through American Express to include checking for space at prospective hotels, and negotiating and contracting meeting services such as hotel sleeping rooms, meeting space and food and beverage. Contact J&J Travel Services at 1-888-565-8728. Failure to do so violates Johnson & Johnson policy and can result in non-reimbursement of the expenses. Making arrangements through any other means is prohibited. This includes using a travel agency other than American Express, booking on Internet Travel Websites or booking directly with an airline or hotel. Institution is to maintain a file of itemized expenses that contains details of all travel expenses and receipts for said expenses. Institution must submit invoices for travel and other project-related expenses to Sponsor for reimbursement based on actual costs incurred and provide copies of travel details and receipts for all expenses >$25. The following guidelines should be used when making travel arrangements.

Expense Category Air Travel • Teleconferencing and video conferencing should be utilized whenever possible to minimize the

need for air travel. • Any air travel booked within two weeks before departure must be pre-approved • Coach class is required when in-flight time < 7 hrs • Business Class is permitted when in-flight time > 7 hrs • The use of private aircraft is not permitted

Meals (one individual) • Must accompany overnight stay • Breakfast < $25, lunch < $35, dinner < $65 per person

Business Meals (more than one individual)

• Breakfast < $25, lunch < $50, dinner < $125 per person (all inclusive of food, tax, & gratuities) • Venues should be conducive to business discussion and not offer entertainment

Hotel Room • Maximum rate per day < $275 excluding taxes • Reasonable and customary expenses for laundry, dry cleaning and/or valet services are

reimbursable only if trip exceeds five consecutive days • In room movies, video rentals and charges for use of local Health Club are reimbursable for

extended trips (> 3 business days) with a per trip limit (or per week for extended stays) of $50 • Lodging should not be at resorts, spas, casinos or any establishment offering entertainment

Spouse, Children, Guests

• Sponsor will not reimburse travel expenses for spouses, children or guests. • Spouse & guests should not be invited to company-sponsored meetings, dinners, or entertainment.

Car Rental • To be used only when other suitable means of transportation are not available • Must be < $250 per week • Should be at least B/Compact or better • SUVs are strictly prohibited as rental selection • Must be approved by Sponsor and expressly written in the Work Order

Ground Transportation • Limousine service to airport is limited to trips that last five (5) days or longer or in the event of a safety concern or if commensurate with or less than a taxi. For shorter-term trips, car should be parked in Johnson & Johnson Travel Services-designated long-term car parks.

Educational Items • Educational items should not be provided to Health Care Providers or patients/consumers unless expressly authorized by Sponsor

Meetings • Offsite meetings, including team dinners, require Sponsor approval. • Off-site venues are restricted to meetings of more than 30 people.


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MEMORANDUM OF UNDERSTANDING

THIS MEMORANDUM OF UNDERSTANDING (“MOU”) is made and entered into by and between the DAVID SLATTERY, MD (“Investigator”) and UNIVERSITY MEDICAL CENTER OF SOUTHERN NEVADA (“UMC”) and is entered into concurrent with that certain Clinical Trial Agreement entered into between UMC, Janssen Scientific Affairs, LLC (“Janssen”) and Investigator prior to this date or of even date herewith (the “Agreement”).

RECITALS

WHEREAS, UMC has agreed to serve as the Institution for a certain clinical research study bearing protocol number 39039039APE4001 (the “Protocol”), known as Multicenter Trial of Rivaroxaban for Early Discharge of Pulmonary Embolism from the Emergency Department (MERCURY PE) (the “Study”) with Investigator, a physician fully privileged at UMC, who shall serve as Investigator under said Agreement. A true and correct copy of said Agreement is incorporated by reference in Exhibit A; and

WHEREAS, the parties are entering into this MOU to further clarify their obligations to each other, in particular as it relates to the Budget for the Study as further described herein.

COVENANTS

NOW, THEREFORE, in consideration of the mutual covenants and conditions herein contained, the parties agree as follows:

1. Responsibilities of Investigator.

1.1 Conduct all activities relating to the Study in accordance with the Protocol.

1.2 Ensure that any staff provided by Investigator is qualified to provide services required under the Agreement.

1.3 Ensure compliance in accordance with the terms set forth in the Agreement and Protocol, and with all other applicable federal, international, state, and local laws, regulations, and policies that may provide additional protection for human subjects participating in research conducted under this agreement.

2. Responsibilities of UMC.

2.1 UMC will pay Investigator for the clinical trial services provided in accordance with the Budget which is attached hereto as Exhibit B. Investigator may invoice UMC for services provided no more frequently than monthly. UMC will pay Investigator within thirty (30) days of receipt of payment from Janssen for the services represented by each respective approved invoice.

2.2 UMC shall comply with the terms and conditions as set forth in the Agreement and protocol as Institution.

2.3 UMC shall fulfill all of Site’s obligations concerning IRB approval.

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3. Responsibilities of Investigator and UMC.

3.1 Investigator and UMC shall at all times cooperate for the purposes of fulfilling the obligations of each in accordance with the Agreement and the Protocol and shall share information as appropriate and necessary to fulfill such purposes, including but not limited to any notices received from Janssen or any regulatory body concerning the status of the respective parties that may affect the performance of any party to the Agreement.

4. Invoicing.

Invoices shall be delivered to:

University Medical Center of Southern Nevada Clinical Trials Office 1800 West Charleston Boulevard Las Vegas, NV 89102

Compensation checks shall be payable to “Nevada Emergency Medicine Research Foundation” and shall be delivered to: Dr. David Slattery Department of Emergency Medicine 901 Rancho Lane, Suite #135 Las Vegas, NV 89106


5.1 This MOU shall be in effect for the term of the Agreement unless terminated earlier as set forth in Section 5.2 or 5.3 of this MOU. 5.2 In the case of any breach of this MOU, either party may terminate with thirty (30) days advance written notice to the breaching party. Upon receiving notice of an alleged breach the party against which the breach is asserted shall have ten (10) days to cure the breach. If the breach is not cured within (10) days of notice, this MOU shall terminate.

5.3 Either party may terminate this MOU, without cause, upon thirty (30) days prior written notice to the other party. Such termination shall not relieve either party of any obligation or liability accrued hereunder prior to such termination, or rescind or give rise to any right to rescind any payments made prior to the time of such termination.

6. Notices. Except as provided in Section 4 hereof regarding payment of invoices, any notice or other communication required or permitted to be given to the other party shall be in writing and shall be deemed to have been properly given and effective: (a) on the date of delivery if delivered in person during recipient’s normal business hours; or (b) on the date of delivery if delivered by courier, express mail service or first-class mail, registered or certified, return receipt requested. Such notice shall be sent or delivered to the respective addresses given below, or to such other address as either party shall designate by written notice given to the other party as follows:

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To Investigator:

David E. Slattery, MD Emergency Medicine Physicians University of Nevada School of Medicine, Department of Emergency Medicine 901 Rancho Lane, Suite #135 Las Vegas, NV 89106

Attn: Research Director

To UMC:

University Medical Center of Southern Nevada 1800 West Charleston Boulevard Las Vegas, NV 89102 Attn: Contracts Management

7. Insurance. Each party shall maintain an insurance policy at levels sufficient to support its obligation assumed under this MOU and as required by applicable law. This provision shall in no way be considered a waiver of UMC’s right to raise the defense of sovereign immunity under NRS 41.0305 to NRS 41.039, which right UMC specifically reserves. 8. Independent Entities. Each party recognizes that each is an independent entity and agrees that no party shall be liable for any other party’s contracts, obligations, torts, or representatives. Each party shall not be held out as liable for any other party’s contracts, obligations, torts or representatives. Each party shall not be responsible for the legal and/or contractual obligations related to employees of any other party. Each party shall be solely responsible for all state and federal laws pertaining to employment taxes, income withholding, unemployment compensation contributions and other related employment related statutes. 9. Governing Law. This MOU shall be governed by and constructed under the laws of the State of Nevada. Any legal action or dispute arising out of or in any way related to this MOU shall be brought in a state or federal court of competent jurisdiction in Nevada.

10. Severability. The parties recognize that this MOU is at all times subject to federal, state and local laws and regulations. The parties further recognize that this MOU shall be subject to any amendments to such existing laws and regulations and to new laws and regulations. In the event that any of the provisions or portions of this MOU are held to be unenforceable or invalid under any provisions of law or by any court of competent jurisdiction, the validity and enforceability of the remaining provisions or portions shall not be affected. The parties shall, within a reasonable period of time, attempt to negotiate a new MOU with respect to any provision determined to be inconsistent with or invalid under any new laws and may attempt to negotiate a new MOU in the event the MOU becomes null and void.

11. Waiver. The waiver by a party of any breach of any term, covenant or condition herein shall not be deemed a waiver of any subsequent breach of the same or any other term, covenant or condition of this MOU.

12. Entire Agreement, Modifications. This MOU, together with the Agreement, contains the entire agreement and understanding between the parties with respect to the subject matter hereof and supersedes all prior and contemporaneous agreements and understandings, express or implied, oral or written, with

3

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respect to the subject matter of this MOU and the Agreement. This MOU may not be altered, modified or amended except in writing and with the signature of both parties.

13. HIPAA Requirements. To the extent applicable to the Agreement and this MOU, University and UMC agree to comply with the Health Insurance Portability and Accountability Act of 1996, as codified at 42 USC 1320d (“HIPAA”) and any current and future regulations promulgated thereunder including without limitation the federal privacy regulations contained in 45 C.F.R. Parts 160 and 164 (the “Federal Privacy Regulations”), and the federal standards for electronic transactions contained in 45 C.F.R. Parts 160 and 162, all collectively referred to herein as “HIPAA Requirements.”, including the Health Information Technology for Economic and Clinical Health Act (“HITECH”) that was adopted as part of the American Recovery and Reinvestment Act of 2009. Both parties agree not to use or further disclose any Protected Health Information (as defined in 42 USC 1320d), other than as permitted by HIPAA Requirements and the terms of the Agreement and protocol. Both parties shall make their internal practices, books, and records relating to the use and disclosure of Protected Health Information available to the Secretary of Health and Human Services to the extent required for determining compliance with the Federal Privacy Regulations.

14. Fiscal Fund Out. It is understood and agreed, notwithstanding the provisions, terms and conditions of this MOU, that in the event any recognized funding authority fails to appropriate sufficient funds to UMC to enable obligations to be fulfilled under the MOU for the ensuing year or any part thereof, all rights and obligations of the parties under this MOU shall terminate upon thirty (30) days written notice. It is further understood and agreed that notwithstanding the provisions, terms and conditions of this MOU this paragraph shall be superseding. 15. Counterpart Signatures; Electronic Transmission. This MOU may be executed in any number of counterparts, each of which shall be deemed to be an original, and all of such counterparts shall constitute one MOU. Delivery of this MOU may be accomplished by electronic transmission of this MOU. 16. Assignment/Binding on Successors. No assignment of rights, duties or obligations of this MOU shall be made by either party without the express written approval of a duly authorized representative of the other party. Subject to the restrictions against transfer or assignment as herein contained, the provisions of this MOU shall inure to the benefit of and shall be binding upon the assigns or successors-in-interest of each of the parties hereto and all persons claiming by, through or under them. 17. Non-Excluded Healthcare Provider. Investigator represents and certifies to UMC that neither he nor any of his affiliates (a) are excluded from participation in any federal health care program, as defined under 42 U.S.C. §1320a-7b (f), for the provision of items or services for which payment may be made under such federal health care programs and (b) has arranged or contracted (by employment or otherwise) with any employee, contractor or agent that such party or its affiliates know or should know are excluded from participation in any federal health care program, to provide items or services hereunder. Investigator represents and certifies to UMC that no final adverse action, as such term is defined under 42 U.S.C. §1320a-7e (g), has occurred or is pending or threatened against Investigator or his affiliates or to his knowledge against any employee, contractor or agent engaged to provide items or services under this MOU (collectively “Exclusions / Adverse Actions”).

SIGNATURE PAGE FOLLOWS

4

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IN WITNESS WHEREOF, the parties have caused this MOU to be duly executed as of the dates set forth below. DAVID SLATTERY, MD By: ___________________________________________

David Slattery, MD Date Investigator

UNIVERSITY MEDICAL CENTER OF SOUTHERN NEVADA By: ________________________________________ Mason VanHouweling Date Chief Executive Officer

5

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Exhibit A


(Agreement by reference only; page intentionally left blank). 6

Page 198 of 255

Exhibit B

BUDGET

CPT Code

Visit 1

Phone Follow

Up #1

Phone Follow

Up #2

Phone Follow

Up #3

Visit 2 Visit 3

Screening and

Randomization

Day 3 (+/-1 day)

Day 7 (+/-2 days)

Day 14 (+/- 2 days)

Day 30 (-5

days)

EOS/ET

Informed Consent N/A $ 100

Physical Exam 99201-99205 $ 200

12-Lead ECG 93000 $ 100 Randomization N/A $ 10 Dispense/Administer study drug N/A $ 50 $ 50 Drug Accountability N/A $ 10 $ 10 $ 10 $ 15 $ 15 PI Study Oversight $ 50 $ 30 $ 20 $ 20 $ 50 $ 50 PI Effort $ 200 $ - $ - $ - $ 200 $ 200 Subtotal $ 710 $ 40 $ 30 $ 30 $ 315 $ 265

Per Patient $ 1,390 Total Patients 12 Total Per Patient $ 6,680

Pass Through Fees (invoiceable) Start Up Fees inclusive of

Indirects Description PI

Start Up fee A non-refundable start-up fee is assessed to cover the effort of the study team to open the study and may include: protocol analysis, staff training, development of study-specific documents, pre-screening, recruitment activities, and study team/sponsor communications.

$ 1,500

Pharmacy Initiation Fee Assessed for protocol review and budget development, site initiation visit, procurement, inventory and storage of the study drug, development of drug information sheets, computerization, study sponsor consultation and staff education.

$ 1,000

$ 2,500

7

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Invoiced per Occurrence Description PI Pharmacy Maintenance (annual) Includes inventory maintenance and

re-ordering, record keeping, drug distribution, monitor visits, patient randomization, and special packaging/labeling. Fee based on monthly charge of $100.

$ 1,200

Pharmacy Close Out Includes monitor close-out, reconciliation, drug destruction, and return of drug supplies.

$ 300

Follow up 1, Inpatient Only paid for subjects who remain inpatient at Day 3 (+ 1 day). Payment will reflect Phone call, Follow Up 1 amount + additional amount required for Inpatient visit for the total listed here.

$ 100

Follow up 2, Inpatient Only paid for subjects who remain inpatient at Day 7 (+ 2 days). Payment will reflect Phone call, Follow Up 2 amount + additional amount required for Inpatient visit for the total listed here.

$ 100

Unscheduled Visit Only paid for protocol-related clinic visits, not routine care visits, in addition to those outlined in the Visit Schedule. Will repeat as needed.)

$ 100

Screen Failures Invoiced to sponsor for reimbursement of screening visit if patient is found not to be eligible. After 1 SF, 1 additional SF for every 5 subjects enrolled.

$ 710

8

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1

AMENDMENT ONEPROJECT CONSULTANT AGREEMENT

THIS AMENDMENT ONE (“Amendment”) is made and entered into as of this ___ day of January, 2016, by and between the UNIVERSITY MEDICAL CENTER OF SOUTHERN NEVADA, a county-owned hospital established pursuant to Chapter 450 of Nevada Revised Statutes (hereinafter “UMCSN” or “Hospital”) and THE ROSENBERG GROUP LLC (“Provider”). Terms not otherwise defined herein shall have the meaning set forth in the Agreement (as defined below).

RECITALS

WHEREAS, UMCSN entered into an Agreement with Provider for certain consultant services (“Project”) dated July 28, 2015 (“Agreement”);

WHEREAS, both parties wish to amend the Agreement in order to fund the Project for additional services requested by UMCSN related to its ambulatory, revenue cycle and surgery departments;

WHEREAS, UMCSN has consented to the delegation of certain Services by the Designated Contact and agree to allow the Provider to utilize an additional consultant on the Project;

NOW, THEREFORE, the parties agree as follows:

1. The second sentence of Section II.A shall be deleted in its entirety and replaced with the following:

“Hospital will compensate Provider the amount of $190.00 per hour for an amount not to exceed $1,311,000 during the Term (“Provider Compensation”).”

2. The first sentence in Section II.B.3 shall be deleted in its entirety and replaced with the following:

“Provider shall be entitled to payment of certain travel and other miscellaneous expenses, not to exceed a total amount of $180,000 in accordance with Section XI.P or such other expense policies of the Hospital.”

3. Except as expressly amended in this Amendment, the Agreement shall remain in full force and effect.

[SIGNATURE PAGE TO FOLLOW]

Page 219 of 255

2

IN WITNESS WHEREOF, the parties have executed this Amendment to be effective as of the day and year first written above.

HOSPITAL: PROVIDER:

University Medical Center of Southern The Rosenberg Group LLCNevada

By:__________________________ By:______________________________ Mason VanHouweling, CEO Brian G. Rosenberg, CEO

_____________________________ _________________________________Date Date

01/07/2016

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EHR UPDATEAUDIT AND FINANCE COMMITTEE

January 13, 2016Page 222 of 255

Activities Completed over past month

Completed reference checks

Sub-Committee Recommendations

Primary Committee Recommendation

2

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Summary of Selection Process Timeline3

Requirements Gathering (July

– August)

Create and Issue RFI (August)

For selection committees

(September)

Vendor Initial Presentations and

Scoring (September)

Detailed Demonstrations and

scoring (October) – 2 Vendors

Sub-committee Review and

Recommendations (November)

Reference Checks and Due Diligence

(December)

Primary Selection Committee (December)

Award and Start of contracting process

(January)

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Primary Committee List

Mason VanHouweling

Kurt Houser

Ernie McKinley

Stephanie Merrill

Debra Fox

Andrew Chung

Linda Garrison

Lonnie Richardson

Mary Brann

Meddie Nazifi

Vick Gill

Virginia Carr

Dr. Dale Carrison

Dr. David Obert

Katherine Ryan

Carissa Rey

Christopher Jones

Hillary McElroy

Dr. Hidenobu Shigemitsu

Lisa Gorlick

Melody Talbott

Michael Porter

Shelley Russell

Brad Umstead

Rosemary Gharibian

4

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Primary Selection Committee Vote5

Epic – 24 Recommendations

Cerner – 1 Recommendation

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Sub-Committee List

Medical Records

Emergency Department

Pharmacy

Radiology

Revenue Cycle

Chargemaster

Care Management

Patient Accounting

Surgery

Academic Affairs

Maternity

Nursing

Pediatrics

Physician

Lab

Implementation

Technology

6

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Sub-Committee Recommendations7

15 Epic

1 Cerner (Lab)

Lab was not a requirement of the RFI but was given the

option to change solutions as part of the EHR project

Lab would like to keep their current product

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Key Reasons for Epic Recommendation8

Enterprise license model

No sunsetting of applications

Quality and compatibility of references

Out of the box interoperability

Functionality – ease of use, patient portal, mobile

Dashboards and benchmarking

Strength of Revenue Cycle product

Implementation approach for Epic strongly preferred

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KLAS Report Summary - 20149

Category Epic Ranking Cerner Ranking

Overall #1 #2

Physician Practice #1 #3

Acute Care #1 #2

ED #2 #7

Scheduling #2 #5

Patient Accounting #1 #8

Patient Portal #1 #8

Radiology #3 #9

Surgery #1 #5

Anesthesia #2 #8

Ambulatory #1 #4

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KLAS Implementation Report10

Category Epic Ranking Cerner Ranking

Quality of Implementation 7.4 6.2

Implementation on Time 8.2 7.2

Product Works as Promised 8.0 6.0

Quality of Training 7.3 5.9

Satisfaction “Newly Live” 87.4 69.1

Satisfaction 2 years later 86.9 77.5

Avoids Nickel and Diming 93% 36%

Lack of Available Resources 9% 7%

Inexperienced Resources 28% 20%

Issues with Training Quality 5% 17%

Training Incomplete 5% 28%

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Cost Considerations11

Internal resource requirements were within 5% of each

other

Epic’s Enterprise License provides UMC with many

solutions that can be used in the future

Cerner is a lower price initially for the proposed

solutions, but higher when viewed over 5 years or more

Consideration was given to desired solutions or content

available in one but not the other

Adjustments were made to ensure compared numbers

presented equal volumes and user counts

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Epic Contract Costs12

Total Epic contract cost is projected at $24,753,000

including:

Software

Implementation fees

Travel

Various third party software and content

Hosting setup

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Next Steps13

Award the RFI to Epic contingent upon coming to terms on a contract

Begin contracting process

Engage with Gartner to review Epic contract

Suggest terms to negotiate

Share considerations given to other Epic customers

Negotiate contract with preferred provider

Present contract for approval once completed (March Governing board meetings)

Proceed with project preparation activities

Finalization of total project budget

Project team space

Completion of staffing model

Creation of the project charter

Infrastructure improvements

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NOVEMBER FY2016 FINANCIALS

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FY2016 Executive Narrative

Five consecutive months with positive net operating

income.

Continued volume and payor mix improvements

have helped contribute to the favorable variance

over budget.

Hospital occupancy remains at about 90% of

capacity for seven consecutive months.

Outpatient surgeries exceeding prior years volumes.

2 Page 239 of 255

FY2016 November Financial Summary Comparison to FY2016 Budget

Monthly

Total

Favorable

(Unfavorable)

FYTD 2016 Favorable

(Unfavorable)

Net Revenue $50.7M $8.3M $244.6M $30.0M

Total Operating

Expenses

$47.3M $1.0M $234.0M $7.3M

Net Operating

Income

$3.4M $9.3M $10.6M $37.3M

3

For the month ended November 30, 2015

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FY2016 Executive Narrative (Balance Sheet Highlights)

Net Patient AR improved over prior fiscal year due to a reduction in AR Days. (Net Patient AR: November $69.4M, Prior Year $116.1M)

Due to aging facilities and equipment, Net PP&E continues to decrease and outpaces current capital expenditures. (Working Capital: November $68.2M, Prior Month $64.1M) (Net PP&E:

November $171.6M, Prior Month $173.1M)

Net Position improved due to November results, but still remains negative due to the recent implementation of GASB 68 and recording of net pension liability. (Net Position:

November ($318M), Prior Month ($320M)) (GASB 68 pension liability from FY2015 $375M)

Future major capital expenditures: required replacement EHR system

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Net Patient Revenue ($ in 000’s)

5

10,000

15,000

20,000

25,000

30,000

35,000

40,000

45,000

50,000

55,000

60,000

JUL AUG SEP OCT NOV DEC JAN FEB MAR APR MAY JUN

2016 Budget 2016 FYTD (Thru Nov) 2015


Net Patient Revenue:

•Exceeded budget by $8.4M

•Inpatient ancillary exceed budget

•Outpatient revenue exceed budget

•Change in payor mix

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UMC Payor Mix (as a % of Gross Revenue)

22% 22% 17%

22% 20% 23% 21% 21% 21% 23%

20% 19% 22%

28% 29%

30%

27% 28%

31%

29% 28% 32%

31% 32% 33%

31%

22% 23%

25% 24% 26%

21%

24% 23%

23% 23%

23% 25% 25%

4% 8%

7% 7% 7%

6% 5% 7%

6% 4% 6%

5% 5% 4%

4% 7%

5% 5% 5% 5% 6%

6% 5% 6% 5% 5%

19% 15% 15% 14% 14% 14% 16% 15% 13% 13% 14% 13% 12%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Nov'14 Dec Jan Feb Mar April May June July Aug Sept Oct Nov'15

Managed Care Medicaid Medicare Pending Gov't Self-Pay

6 For the month ended November 30, 2015 Page 243 of 255

Total Operating Costs ($ in 000’s)

7

40,000

41,000

42,000

43,000

44,000

45,000

46,000

47,000

48,000

49,000

50,000




Operating Costs:

•Under budget by $1.0M

•Process changes in Pathology

•Volume decreases

•Changes in provider services

•Actuals lower than budgeted

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Key Operational Expenses

24,000

25,000

26,000

27,000

28,000

29,000

30,000


Salaries & Benefits ($ in 000’s)


5,000

5,500

6,000

6,500

7,000

7,500

8,000

8,500


Supplies ($ in 000’s)


Salaries & Benefits:

•Slightly over budget

•Overtime at 5.8%

•Productivity at 101.5%

Supplies:

•Over budget $0.7M

•Change in contracts

•Volume increase in OR

8 Page 245 of 255

Key Operational Expenses

4,000

4,500

5,000

5,500

6,000

6,500

7,000

7,500

8,000


Purchased Services ($ in 000’s)


2,600

2,700

2,800

2,900

3,000

3,100

3,200


Professional Fees ($ in 000’s)


Purchased Services:

•Under budget $1.5M

•Changes in contracts

•Process changes – Pathology

•Volume changes vs. projections

•Actuals lower than budgeted

Professional Fees:

•Under budget $0.1M

•Net contract changes

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Average Daily Census

10


2016 334 328 332 328 355

2015 339 335 338 318 333 339 354 344 349 327 324 331

2014 360 370 331 322 334 340 332 332 357 354 353 346

300

320

340

360

380

400

420

For the month ended November 30, 2015 Does not include observations

Total Occupancy 415

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Average Daily Census w/Observations

333 339 354

344 349

327 324 331 334 328 332 328

355 34

37 34

20

45

43 40 42

47 44 44

27

26 367

376 388

364

394

370 364 373

381 372 376

355

381

100

200

300

400

500

NOV-15 DEC-15 JAN-15 FEB-15 MAR-15 APR-15 MAY-15 JUN-15 JUL-16 AUG-16 SEP-16 OCT-16 NOV-16

Total Occupancy 415

11 For the month ended November 30, 2015 Page 248 of 255

Adjusted Patient Days

12


2016 16,117 15,629 15,702 15,804 15,559

2015 16,117 16,122 15,949 15,763 15,200 15,716 16,607 14,412 16,223 15,470 15,705 15,207

2014 16,881 17,676 15,043 15,820 15,675 16,075 15,784 13,787 16,343 16,790 16,690 15,490

13,000

14,000

15,000

16,000

17,000

18,000

19,000

20,000


Page 249 of 255

ED Volume

For the month ended November 30, 2015 13

13


2016 9,456 9,488 9,617 9,818 9,232

2015 9,536 9,239 9,719 9,493 9,039 9,547 10,609 9,250 10,487 9,958 10,051 9,689

2014 10,299 10,491 9,628 9,845 9,762 10,344 10,815 10,118 11,110 10,799 10,402 9,402

8,000

8,500

9,000

9,500

10,000

10,500

11,000

11,500

12,000

Page 250 of 255

Outpatient Visits (Includes Quick & Primary Care Centers)

14

For the month ended November 30, 2015 Excludes Ed & Closed Clinics


2016 21,281 20,609 22,290 22,051 20,945

2015 19,302 19,405 20,900 21,535 19,767 21,718 25,531 23,539 23,807 21,886 22,641 22,490

2014 17,468 17,697 19,077 19,637 19,997 21,409 23,310 21,127 23,259 21,937 21,369 20,142

16,000

18,000

20,000

22,000

24,000

26,000

28,000

30,000

Page 251 of 255

Outpatient Surgery

15


2016 640 592 636 661 540

2015 594 631 557 715 523 608 531 529 666 625 617 628

2014 704 707 606 652 572 584 541 505 567 556 580 415

250

300

350

400

450

500

550

600

650

700

750

For the month ended November 30, 2015 Includes 111 robotic

surgeries for FYTD 2016 Page 252 of 255

Surgical Stats


2016 313 275 192 273 192

2015 300 346 268 349 237 304 273 270 278 347 312 374

2014 545 515 434 402 351 315 342 319 329 387 323 289

0

100

200

300

400

500

600

Endo


2016 31 25 17 16 22

2015 10 20 24 30 23 22 23

Minutes FY2016 4,751 4,815 4,202 3,229 3,261

Minutes FY2015 1,844 2,779 4,581 4,972 5,116 3,681 3,306

5

10

15

20

25

30

35

Robotics

Projected ROI Capacity

16 Page 253 of 255

Page 254 of 255

Page 255 of 255

Documents

UMC - Page 2 of 255Robyn Caspersen (non-voting member) Donald Mackay Harry Hagerty Jeff Ellis Absent: Michael Saltman - excused Others Present: Stephanie Merrill, Chief Financial Officer