DMH009_CSP009743_-_Contract_REV.pdf

Ing Index No.: DMH009

Eff. Date: 12/01/23

STATE OF OHIO

DEPARTMENT OF ADMINISTRATIVE SERVICES

GENERAL SERVICES DIVISION

OFFICE OF PROCUREMENT SERVICES

4200 SURFACE ROAD, COLUMBUS, OH 43228-1395

MANDATORY USE CONTRACT FOR: ELECTROENCEPHALOGRAM COMBINED TRANSCRANIAL MAGNETIC

STIMULATION (ETMS) PROGRAM

CONTRACT NUMBER: CSP009743 EFFECTIVE DATES: 08/26/22 TO 06/30/23

* Renewal through 11/30/25

The Department of Administrative Services has accepted Proposals submitted in response to Request for Proposal (RFP) No.

SRC2472 that opened on 03/09/22. The evaluation of the Proposal responses has been completed. The Offeror listed herein has been determined to be the highest ranking Offeror and has been awarded a Contract for the services listed. The respective Proposal response including, Contract Terms & Conditions, any Proposal amendment, special Contract Terms & Conditions, specifications, pricing schedules and any attachments incorporated by reference and accepted by DAS become a part of this Services Contract.

This Requirements Contract is effective beginning and ending on the dates noted above unless, prior to the expiration date, the Contract is renewed, terminated, or cancelled in accordance with the Contract Terms and Conditions.

*This Requirements Contract is available to the Ohio Department of Mental Health and Addiction Services as applicable.

The agency is eligible to make purchases of the contracted services in any amount and at any time as determined by the agency. The State makes no representation or guarantee that department will purchase the volume of services as advertised in the Request for Proposal.

This Requirements Contract and any Amendments thereto are available from the DAS Web site at the following address:

https://procure.ohio.gov/

*Denotes a twenty-four month renewal, per amendment 4.

Eff. Date.: 07/01/25

MUTUALLY AGREED UPON CLARIFICATIONS / MODIFICATIONS TO THE RFP

*EFFECTIVE 07/01/25:

CSP907222 DMH009 - eTMS Deliverables SFY26

EFFECTIVE 07/01/24, AS APPLICABLE:

CSP009743 DMH009 - Cost_Summary_Form (V2)

EFFECTIVE 12/01/23-11/30/25, AS APPLICABLE:

CSP009743 DMH009 - eTMS Renewal Request for Submission 2.0 CSP009743 DMH009 - Cover Letter CSP009743 DMH009 - Table of Contents CSP009743 DMH009 - Addendum B. Candidate References CSP009743 DMH009 - Gantt Chart CSP009743 DMH009 - Cost_Summary_Form (V1)

EFFECTIVE 05/01/23, AS APPLICABLE:

DMH009 - April 2023 invoice DMH009 - 02_03_23_FINAL Replacement Personnel Corrective Action Plan

The following documents supplement/amend the Corrective Action Plan, as applicable:

DMH009 - DAS & OMHAS Request for Additional Information Concerning Corrective Action Plan DMH009 - 04_03_23_DAS_Response DMH009 - 03_24_23_DAS_Response DMH009 - 03_09_23_Response_DAS_updated DMH009 - Clinical and FDA Cost Summary Form 04_25_23 DMH009 - 03_24_23_CAP_Medical_Org_Chart DMH009 - Personal Profile Summaries DMH009 - Revised Gantt Chart DMH009 - Business Associate Agreement DMH009 - Clinical Services Agreement DMH009 - Equipment and Supplies List DMH009 - SOC 2 Report

DMH009 - Vendor Clarifications - 7.0 – Accepted 08/24/22 DMH009 - Revised Cost Summary 5s 6m – Accepted 07/21/22 DMH009 - Revised Gannt Chart 5s 6m – Accepted 07/21/22 DMH009 – Supplement S – Accepted 08/26/22

Professional Liability (Medical Malpractice) Insurance appropriate to the Contractor’s profession, with limits not less than $5,000,000 per occurrence or claim, $5,000,000 aggregate. Coverage shall be sufficiently broad to respond to the duties and obligations as is undertaken by Contractor in this agreement and shall cover all applicable Contractor personnel or subcontractors who perform professional services related to this agreement.

*Denotes an update to the scope of work and pricelist, effective on all orders placed on or after 07/01/25, per amendment 6.

Eff. Date: 11/15/24 Page No. 3

COST SUMMARY FORM

Electroencephalogram Combined Transcranial Magnetic Stimulation (eTMS) Program

CSP009743

SFY24 Costs (12/01/23-06/30/24) to be paid in accordance with CSP009743 DMH009 - Cost_Summary_Form.

DESCRIPTION

UNIT OF

MEASURE

COST

eTMS-1 2024: Central Management Team, Contracting, Equipment Procurement and Maintenance, Supplies, Operations, IT Infrastructure, data collections, collation, analysis, summary of monthly and periodic reporting and Clinical Site Training X 7 Deliverable: Managing and maintaining Clinical sites 1-7

NOT TO

EXCEED $1,712,446.17

eTMS-2 2024: Project Management, Advertising, Marketing Materials, Peer-to-Peer Network, Recruiting and Site Support. X 7 Months Deliverable: Recruiting, Peer-to-Peer mentoring, Advertising

NOT TO

EXCEED $842,340.79

eTMS-3 2024: Central Medical Oversight, Medical Operations, Patient Evaluation & Management Consultation and ongoing site training - Quality of Life Medical Management. (Monthly recurring costs of QOL) eTMS) x 7 months Deliverable: Clinical Sites 1-7: enrolling and medical oversight up to an average of 29 patients/month.

NOT TO

EXCEED

$1,751,563.04 eTMS-4 2024: 203 Patient Treatment Quality of Life X 7 Months Deliverable: Clinical Sites 1-7: enrolling and treatment of Quality of Life (QOL) up to an average of 29 patients/month.

NOT TO

EXCEED $1,238,300.00

eTMS-5 2024: Regulatory Implementation for FDA IDE-Approved Clinical Trial Phase II of eTMS Trial x 4 Months plus equipment for Phase II additional trial site Deliverable: FDA Phase II Trial Preparation for eTMS PTSD Trial in Dayton, Ohio, Setup new Trial Site in Columbus, NOT TO

EXCEED $455,350.00

*SFY25 Costs (effective 07/01/24-06/30/25) to be paid in accordance with CSP009743 DMH009 - Cost_Summary_Form (V2)

DESCRIPTION

UNIT OF

MEASURE

COST

eTMS-1 2025: Central Management Team, Contracting, Equipment Procurement* and Maintenance, Supplies, Operations, IT Infrastructure data collections, collation, analysis, summary of monthly and periodic reporting and Clinical Site Training. X 12 Months Deliverable: Infrastructure for managing and maintaining Clinical sites 1-7: New Lexington, Barnesville, Youngstown, Columbus, Cleveland, Dayton, Toledo

NOT TO

EXCEED $805,000.00

eTMS-2 2025: Project Management, Advertising, Marketing Materials, Peer-to-Peer Network, Recruiting and Site Support. X 12 Months Recruiting at Clinical Sites 1-7: face-to-face meetings, social media advertising, speaking engagements and attending outreach programs in each Clinical area.

NOT TO

EXCEED $436,236.00

eTMS-3 2025: Central Medical Oversight, Medical Operations, Patient Evaluation & Management Consultation and ongoing site training - Quality of Life Medical Management. (Monthly recurring costs of QOL) eTMS) x12 months Deliverable: Clinical Sites 1-7: enrolling and medical oversight up to an average of 51 patients/month.

NOT TO

EXCEED $1,758,000.00

eTMS-4 2025: 250 Patient Treatment Quality of Life X 12 Months Deliverable: Clinical Sites 1-7: enrolling and treatment of Quality of Life (QOL) up to an average of 51 patients/month.

*Additional funds from 2022 used to treat an additional 22 patients (average) per month.

NOT TO

$1,525,000.00

*$2,208,200.00 eTMS-5 2025: Regulatory Implementation for FDA IDE-Approved Clinical Trial Phase II of eTMS Trial x 12 Months – Patients will start August 2024-November 2025 Deliverable: FDA Phase II Trial Preparation for eTMS. Treatment of 140 patients between two FDA Trial sites, FDA Oversight, Medical Oversite, Data Collection, Recruiting, Peer Mentoring, IT Support, treatment of 140 patients, supplies, maintenance of equipment, project management and State monthly and Quarterly reporting.

*Additional funds from 2022 used for technology subscription and staff with additional FDA chair.

NOT TO

$1,475,764.00

*$138,983.00

*The addition of funding added with amendment 4 is not binding to the State until DMH receives all required approvals relating to the spending of the funds.

*Denotes an update to the pricelist, effective on all orders placed on or after 07/01/24 and the addition of contract terms, per amendment 4.

Eff. Date: 07/01/25 Page No. 4

COST SUMMARY FORM

*The costs below will be paid in accordance with CSP907222 DMH009 - eTMS Deliverables SFY26, effective 07/01/25.

SERVICE DESCRIPTION QTY RATE

TOTAL

AMOUNT

1. DIRECT PATIENT CARE

eTMS Treatment [per patient] (includes evaluation, 20-30 sessions, monitoring, and follow-up; assumes one chair and one sonal per site)

$6,000.00

$48,000.00

2. EQUIPMENT AND TECHNOLOGY BY SITE

Wave Neuroscience eTMS Technical Support & Subscriptions 1 $6,700.00 $6,700.00

Equipment Rental and Maintenance 1 $2,500.00 $2,500.00

3. PROGRAM ADMINISTRATION BY SITE

Project Management and Operations 1 $7,133.33 $7,133.33

Training and Clinical Oversight 1 $9,000.00 $9,000.00

Marketing and Patient Recruitment 1 $10,000.00 $10,000.00

TOTAL MONTHLY BUDGET PER SITE $83,333.33

TOTAL MONTHLY BUDGET $416,666.66

Total Patients Served: 100 per year per site. 500 patients total per year.

*Denotes an update to the pricelist, effective on all orders placed on or after 07/01/25, per amendment 6.

Eff. Date: 07/01/25 *Page No. 5

CONTRACTOR INDEX

CONTRACTOR AND TERMS: CONTRACT NO: CSP009743

0000047127 Perry Behavioral Health Choices Inc TERMS: Net 30 Days

221 North Main Street New Lexington, OH 43764

CONTRACTOR’S CONTACT: Joe Charles Telephone: (330)-687-0742 Email: jcharles@jlcservicesinc.com

APPROVED SUBCONTRACTOR(S):

Brain Treatment Center - Columbus JLC Services, Inc Meridian HealthCare Wave Neuro Wright State University WVUMedicine Zeto

*Denotes repagination, per amendment 6.

jcharles@jlcservicesinc.com

Eff. Date.: 07/01/25

SUMMARY OF AMENDMENTS

Amendment Number

Effective Date

Description

6 07/01/25

This amendment is used to denote an update to the scope of work and the pricelist, effective on all orders placed on or after 07/01/25. Additionally, this amendment is issued to denote repagination.

All other prices, terms and conditions remain unchanged.

5 11/15/24

This amendment is issued to denote the addition of contract terms, an update to the Scope of Work, and an update to the pricelist with additional funds for deliverables, effective on all orders placed on or after 07/01/24.

All other prices, terms and conditions remain unchanged.

4 12/01/23

This amendment is issued to notify of a twenty-four (24) month renewal as a result of mutual agreement, effective 12/01/23 – 11/30/25. Additionally, this amendment is issued to denote an update to the Scope of Work and the pricelist, effective on all orders placed on or after 12/01/23.

All other prices, terms and conditions remain unchanged.

3 11/01/23

The State of Ohio elects to exercise its option to renew the subject contract for an additional one month effective 11/01/23 through 11/30/23.

All other prices, terms and conditions remain unchanged.

2 05/03/23

This amendment is issued to update the Ohio Buys pricelist to remove all items and replace them with a single amount (AMT) line item effective on all orders on or after 05/03/23.

Additionally, this amendment is issued to correct the agency’s name on page 1 of this contract and to add the asterisk to the bottom of page 3.

1 05/01/23

This amendment is issued to denote an update to the scope of work, update the approved subcontractors list, and the pricelist, effective on all orders placed on or after 05/01/23. Additionally, this amendment is issued to notify that as a result of mutual agreement between the State of Ohio and the Contractor, this contract is renewed for an additional four (4) months, effective 07/01/23 through 10/31/23.

All other prices, terms and conditions remain unchanged.