STATE OF IDAHO Department of Health and Welfare Contract CONTRACT NO. H0866300 FEDERAL ID. NO. 20216159600 CONTRACT NAME: ROBERT WECHSLER, MD CONSULTANTS IN EPILEPSY NEUROLOGY, PLLC CFDA NUMBER: DUNS NUMBER: This Contract is entered into by the State of ldaho, Department of Heatth and Welfare, hereinafter referred to as the DEPARTMENT, and ROBERT WECHSLER, MD I CONSULTANTS IN EPILEPSY NEUROLOGY, PLLC, hereinafter referred to as the CONTRACTOR. This contract is anticipated to be effective as of 07/01/2015 and expire on 06/30/2016. As outlined in Paragraph II of the Contract Terms and Conditions, this Contract will not be effective until signed by all parties. WITNESSETH: The DEPARTMENT enters into this Contract pursuant to authority granted to it in Title 56, Chapter 10, Idaho Code. The CONTRACTOR agrees to undertake performance of this Contract under the terms and conditions set forth herein. The Contractor agrees to provide, and the Department agrees to accept the services detailed in the Scope of Work and generally described as follows: Screening and enrollment of children into an Expanded Access Program for access to the drug Epidiotex (cannibidiot) for intractible epilepsy, and heatth monitoring of enrolled children. The following Attachments are hereby incorporated and made a part of this Agreement: General Terms and Conditions Riders Scope of Work Performance Metrics Cost/Billing Procedure Reports TOTAL CONTRACT AMOUNT: $223,500.00 SUB OBJECT: PROGRAM COST ACCOUNT (PCA) 12236 ALL DIV ADMIN) A19018 CONTRACT MONITOR: Christine Hahn CONTRACT MANAGER: Elke Shaw-Tuttoch Contract Cover Sheet Page 1 of 1 iV. Generai Terms and Conditions General Terms and Conditions DEFINITIONS. As used in the Contract, the following terms shall have the meanings set forth below: A. Contract shall mean the Contract Cover Sheet, these General Terms and Conditions, and all Attachments identified on the Contract Cover Sheet. The Contract shall also include any negotiated and executed amendment to the Contract or any task order negotiated, executed, and implemented pursuant to provisions of the Contract. B. Contract Manager shail mean that person appointed by the Department to administer the Contract on behalf of the Department. "Contract Manager" includes, except as otherwise provided in the Contract, an authorized representative of the Contract Manager acting within the scope of his or her authority. The Department may change the designated Contract Manager from time to time by providing notice to the Contractor as provided in the Contract. C. Contractor shail mean that individual, partnership, corporation, or other entity who executes the Contract or performs services under the Contract. Contractor shall include any subcontractor retained by the Contractor as permitted under the terms of the Contract. D. Department shall mean the State of Idaho, Department of Health and Welfare, its divisions, sections, offices, units, or other subdivisions, and its officers, employees, and agents. CONTRACT EFFECTIVENESS. It is understood that this Contract or any Amendment is effective when it is signed by ail parties, or at a later date if specified in the Contract or Amendment. The Contractor shall not render services to the Department until the Contract or Amendment has become effective. The Department will not pay for any services rendered prior to the effective date of the Contract or Amendment. RENEWAL. The Department reserves the right to extend this contract for additional periods, not to exceed a total of four (4) years, provided the Contractor has demonstrated satisfactory performance in the previous year. Any extension or amendment of this contract shall be in writing, signed by both parties. INDEPENDENT CONTRACTOR STATUS. A. Status The Contractor's status under the Contract shalt be that of an independent contractor and not that of an agent or employee of the Department or the State of idaho. The Contractor shall be responsible for paying all employment?related taxes and benefits, such as federai and state income tax withholding, social security contributions, worker's compensation and unemployment insurance premiums, health and life insurance premiums, pension contributions and similar items. The Contractor shall indemnify the Department and hold it harmless from any and all ciaims for taxes, including but not limited to social security taxes, penalties, attorneys' fees and costs that may be made or assessed against the Department arising out of the Contractor's failure to pay such taxes, fees or contributions. B. Reassiqnment of Contractor Empiovees The Department shall have the right, after having consulted with the Contractor, to require the Contractor to reassign or otherwise remove from the contract any Contractor employee or subcontractor found in good faith to be unacceptable to the Page 1 of 9 V. Vi. Vii. General Terms and Conditions Department. INDEMNIFICATION BY THE CONTRACTOR. The Contractor shall indemnify, defend and save harmless the State of Idaho, and the Department, its officers, agents, and employees, from and against alt liability, claims, damages, tosses, expenses, actions, attorney fees and suits whatsoever, including injury or death of others or any empioyee of the Contractor or subcontractor caused by or arising out of the Contractor's negligent or otherwise wrongful performance, act or omission under the Contract or the Contractor's failure to compiy with any state, federal or local statute, law, regulation, or rule. Nothing in this provision shall extend the Contractor's indemnification of the Department beyond the liability of the Department provided in the ldaho Tort Claims Act Idaho Code 6?901 et seq., the aggregate of which is limited to $500,000 by ldaho Code 6?926. ASSIGNMENT AND SUBCONTRACTENG. The Contractor shaii not subcontract or assign the Contract without the prior written approvai of the Department. The Department will not approve subcontracts unless such subcontracts contain all federal and state requirements and such conditions and provisions as the Department may, in its sole judgment, deem necessary. Notwithstanding the Department's approvai of any subcontract, the Contractor shall be solely responsible for the satisfactory performance of all subcontractors and subcontracted services and for the compensation of all subcontractors. The Contractor shall be and shall remain liable for ail damages to the Department caused by negligent performance or non?performance of the subcontracted services. RECORDS AND DATA. A. Fiscai Records The Contractor shall maintain fiscal records, including its books, audit papers, documents, and any other evidence of accounting procedures and practices, which sufficiently and property reflect all direct and indirect costs of any nature expended in the performance of the Contract. B. Records Maintenance The Contractor shall maintain all records and documents reievant to the Contract for three (3) years from the date of final payment to the Contractor. If an audit, litigation or other action involving records is initiated before the three (3) year period has expired, the Contractor shall maintain records until all issues arising out of such actions are resolved, or until an additional three (3) year period has passed, whichever is later. C. Termination of Contract if the existence of the Contractor is terminated by bankruptcy or any other cause, all program and fiscal records reiated to the Contract in the Contractor's possession shall become the property of the Department and the Contractor shall immediately deliver such records to the Contract Manager. D. Records Review All records and documents relevant to the Contract, including but not limited to fiscal records, shail be available for and subject to inspection, review or audit, and copying by the Department and other personnel duly authorized by the Department, and by federal inspectors or auditors. The Contractor shall make its records available to such parties at all reasonable'times, at either the Contractor?s principal piace of business or upon premises designated by the Department. E. Subcontracts The Contractor shall include the requirements of this section in all approved subcontracts and assignments. Page 2 of 9 CONFIDENTIALITY. The Contractor shail comply with ali applicable state and federal iaws, rules, XI. XII. and regulations concerning confidentiality. The Department wiiI furnish the Contractor with copies of applicable statutes,'rules, and regulations upon receipt of a written request from the Contractor. PUBLIC RECORDS. Pursuant to Idaho Code section 9?335 et seq., as amended during the term of the Contract, information or documents received from the Contractor may be open to public inspection and copying unless they are exempt from disclosure. The Contractor shalt clearly designate individual documents as "exempt" and shall indicate the basis for such exemption. The Contractor shall indemnify and defend the Department for honoring such a designation. The Contractor's failure to designate as exempt any document that is released by the Department shall constitute a complete waiver of any and all claims for damages caused by any such release. If the Department receives a request for materials claimed exempt by the Contractor, the Contractor shail provide the legal defense for such claim. CUSTOMER SERVICE. A. Telephone Contractors who have direct contact with the public in fulfilling this contract shall have their main, published telephone numbers answered by a person during normal business hours. Voice mail for Contractor staff shall provide an option for the caller to obtain immediate assistance if necessary. The Contractor shall endeavor to return telephone cails the same day, and shall respond to phone calls and e?mails not later than forty-eight (48) hours or two (2) business days after the initial contact, whichever is later. B. Correspondence The Contractor shall respond to written correspondence within ten (10) business days. The Contractor shail provide clear, understandable, timer and accurate written information to Department customers as required by this Contract. C. Policies The Contractor shall treat Department staff and customers with respect and dignity, and shall demonstrate a caring attitude to all who ask for assistance. Contractors shall have a written customer service policy that describes how customer service will be incorporated into policies and training. BINDING EFFECT OF FEDERAL PURCHASE OF SERVICE REGULATIONS. The Contract is subject to the provisions of any relevant federal regulations and any relevant provisions of agreements between the State of Idaho and the United States, including but not iimited to State Plans, in effect at the time the Contract is executed, or which thereafter become effective. Such regulations and agreements are on file in the Central Office of the Department and are available for inspection by the Contractor during regutar business hours. FEDERAL AND STATE EXCEPTIONS. If a federal or state audit indicates that payments to the Contractor faii to comply with applicable federal or state laws, rules or reguiations, the Contractor shaii refund and pay to the Department any compensation paid to the Contractor arising from such noncompliance, plus costs, including audit costs. COMPLIANCE WITH CERTAIN LAWS. General Terms and Conditions Page 3 of 9 A. Nondiscrimination The Contractor shall provide ail services funded through or affected by the Contract without discrimination on the basis of race, color, national origin, religion, sex, age, and physicai or mental impairment, and shall comply with all relevant sections of the foiiowing: Title VI of the Civil Rights Act of 1964; Section 504 of the Act of 1973; The Age Discrimination Act of 1975; and, The Americans with Disabilities Act of 1990. The Contractor shall comply with pertinent amendments to such laws made during the term of the Contract and with ail federal and state rules and regulations implementing such laws. B. The Contractor acknowledges that it may have an obiigation, independent of this contract, to comply with the Health Insurance Portability and Accountability Act Sections 262 and 264 of Pubiic Law 104?191, 42 USC Section 1320d, and federal regulations at 45 CFR Parts 160, 162 and 164. If applicable, the Contractor shall comply with all amendments to the law and federal regulations made during the term of the Contract. C. Lobbying 1. The Contractor certifies that none of the compensation under the Contract has been paid or will be paid by or on behalf of the Contractor to any person for influencing or attempting to influence an officer or employee of any governmental agency, a member, officer or employee of Congress or the ldaho Legislature in connection with the awarding, continuation, renewal, amendment, or modification of any contract, grant, loan, or cooperative agreement. 2. if any funds, other than funds provided by the Contract, have been paid or will be paid to any person for influencing or attempting to influence an officer or employee of any governmental agency, a member, officer or employee of Congress or the State Legislature in connection with the Contract, the Contractor shall complete and submit Standard Form "Disciosure Form to Report Lobbying," in accordance with its instructions, and submit a copy of such form to the Department. 3. The Contractor shali require that the language of this certification be included in any subcontract, at all tiers, (including grants, subgrants, loans, and cooperative agreements) entered into as a result of the Contract, and that all sub-recipients shail certify and disclose as provided herein. 4. The Contractor acknowledges that a false certification may be cause for rejection or termination of the Contract, subject the Contractor to a civil penalty, under 31 U.S.C. Section 1352, of not less than $10,000.00 and not more than $100,000.00 for each such false statement, and that the Contractor?s execution of the Contract is a material representation of fact upon which the Department relied in entering the Contract. D. Qualification The Contractor certifies to the best of its knowledge and belief that it and its principals: 1. Are not presently debarred, suspended, proposed for debarment, declared ineligible, or voluntarily excluded from performing the terms of the Contract by a government entity (federal, state or local); 2. Have not, within a three (3) year period preceding the Contract, been convicted of or had a civil judgment rendered against them for commission of fraud or a criminal offense in General Terms and Conditions Page 4 of 9 connection with obtaining, attempting to obtain, or performing a public (federal, state, or locai) transaction or contract under a public transaction; violation of federal or state antitrust statutes or commission of embezzlement, theft, forgery, bribery, falsification or destruction of records, making faise statements,or receiving stolen property; 3. Are not presently indicted for or otherwise criminally or civilly charged by a government entity (federal, state or local) with commission of any of the offenses enumerated in paragraph 2 of this certification; and 4. Have not within a three (3) year period preceding the Contract had one or more public transactions (federal, state, or local) terminated for cause or default. 5. The Contractor acknowledges that a false statement of this certification may be cause for rejection or termination of the Contract and subject the Contractor, under 18 U.S.C. Section 1001, to a fine of up to $10,000.00 or imprisonment for up to five (5) years, or both. E. Faith?Based Organization if the Contractor is a faith-based organization, the Contractor and all approved subcontractors shall: 1. Segregate contract funds in a separate account. 2. Serve all participants without regard to religion, reiigious belief, refusal to hoid a religious belief, or refusal to actively participate in a religious practice. 3. Ensure that Department?referred clients' participation in religious activities, including worship, scripture study, prayer or proseiytization, is only on a voluntary basis. 4. Notify participants of the religious nature of the organization, their right to be served without religious discrimination, their right not to take part in religious activities, their right to request an alternative provider and the process for doing so. 5. Ensure that contract funds are not expended on inherently religious activities. 6. Comply with applicable terms of 42 CFR Parts 54, 54a, and 45 CFR Parts 260 and 1050. F. Tribes if the Contractor is a Tribe, the Contractor and Department recognize that services performed pursuant to this Contract by the Contractor and all approved subcontractors within reservation boundaries are subject to applicable laws, ordinances and regulations of the Tribe. Nothing in this Contract should be construed as a waiver of sovereign immunity. G. Illegal Aliens The Contractor warrants that any contract resulting from this Solicitation is subject to Executive Order 2009?10 it does not knowingly hire or engage any illegal aliens or persons not authorized to work in the United States; it takes steps to verify that it does not hire or engage any illegal aiiens or persons not authorized to work in the United States; and that any misrepresentation in this regard or any General Terms and Conditions Page 5 of 9 employment of persons not authorized to work in the United States constitutes a material breach and shail be cause for termination of its contract. XIV. CONFLICT OF INTEREST. A. Public Official No official or employee of the Department and no other public official of the State of idaho or the United States government who exercises any functions or responsibilities in the review or approval of the undertaking or carrying out of the Contract shall, prior to the termination of the Contract, voluntarily acquire any personal interest, direct or indirect, in the Contract or proposed Contract. B. Contractor The Contractor covenants that it presently has no interest and shall not acquire any interest, direct or indirect, that would conflict in any manner or degree with the performance of its services hereunder. The Contractor further covenants that in the performance of the Contract, no person who has any such known interests shall be employed. XV. LICENSES. For the duration of the Contract, the Contractor shall maintain in effect, and have in its possession, all licenses required by federal, state and local laws, rules and regulations, including, but not limited to business and professional licenses. XVI. REMEDIES. A. Remedial Action If any of the services do not conform to Contract requirements, the Department shall consult with the Contractor and may at its sole discretion require any of the following remedial actions, taking into account the nature of the deficiency: (1) require the Contractor to take corrective action to ensure that performance conforms to Contract requirements; (2) reduce payment to reflect the reduced value of services received; (3) require the Contractor to subcontract all or part of the service at no additional cost to the Department; or (4) terminate the Contract. B. Termination for Convenience The Department or the Contractor may cancel the Contract at any time, with or without cause, upon thirty (30) calendar days written notice to the other party specifying the date of termination. C. Termination for Cause Either party may terminate the Contract immediately upon written notice, or upon such notice as such party, in its sole discretion, deems appropriate, if at any time: the other party is in material breach of any warranty,'term, condition, covenant or obligation under the Contract; judicial interpretation of federal or state laws, regulations, or rules renders fulfillment of the Contract infeasible or impossible; the Contractor's license or certification required by law is suspended, not renewed, or is otherwise not in effect at the time service is provided; or the Contractor fails to comply with any appiicable law, regulation, or ruie. D. Effect of Termination Upon termination by the Department, the Contractor shall: discontinue all work, unless the termination notice directs otherwise; return to the Department any property provided by the Department pursuant to the Contract; and, deliver or otherwise make avaiiable to the Department all data, reports, estimates, summaries and such other information and materials as may have been accumulated by the Contractor in performing the Contract, whether completed or in process. Upon termination by the Department, the Department may take over the services and may award another party a contract to complete the General Terms and Conditions Page 6 of 9 services contemplated by the Contract. Upon termination for cause, the Department shall be entitied to reimbursement from the Contractor for losses incurred as a result of the Contractor's breach. Survival of Terms Any termination, cancellation, or expiration of the Contract notwithstanding, provisions which are intended to survive and continue shall survive and continue, including, but not limited to, the provisions of Sections IV (Independent Contractor Status), (indemnification), th (Records and Data), (Federal and State Audit Exceptions), and Xlil (Compliance with Certain Laws). MISCELLANEOUS. A. General Terms and Conditions Disposition of Propegv At the termination of the Contract, the Contractor shall comply with relevant federal and state laws, rules and regulations and, as applicable, 2 CFR 200.310-316 concerning the disposition of property purchased wholly or in part with funds provided under the Contract Governing Law The Contract shall be governed by and construed under the laws of the State of Idaho. Officials Not Personally Liable In no event shail any official, office, employee or agent of the State of Idaho or of the Department be liable or responsibie for any representation, statement, covenant, warranty or obligation contained in, or made in connection with, the Contract, express or implied. Time of Performance Time is of the essence with respect to the obligations to be performed under the Contract; therefore, the parties shall strictly comply with all times for performance. Notices Any notice given in connection with the Contract shall be given in writing and shaii be delivered either by hand or by certified mail, return receipt requested, to the other party at the address stated below. Either party may change its address by giving notice of the change in accordance with this section. Attorney Fees in the event of a iegal proceeding of any kind instituted under the Contract or instituted to obtain performance or to remedy a default under the Contract, the prevailing party shall be awarded such additional sums as the court may adjudge for reasonable attorney fees and to pay ail costs and disbursements incurred in connection therewith. Appropriation by Legislature Required The State is a government entity and this Agreement shall in no way or manner be construed so as to bind or obligate the State of idaho beyond the term of any particular appropriation of funds by the State's Legislature as may exist from time to time. The State reserves the right to terminate this Agreement in whole or in part (or any order placed under it) if, in its soie judgment, the Legislature of the State of Idaho faiis, neglects, or refuses to appropriate sufficient funds as may be required for the State to continue such payments, or rescinds or requires any return or "give?back" of funds required for the State to continue payments, or if the Executive Branch mandates any cuts or holdbacks in spending. All affected future rights and liabilities of the parties hereto shall thereupon cease within ten calendar days after notice to the Contractor. it is understood and agreed that the State's payments herein Page 7' of 9 provided for shail be paid from Idaho State Legislative appropriations. H. Nonwaiver of Breach The failure of the Department to require strict performance of any term or condition of the Contract, or to exercise any option herein, in any one or all instances shall not be construed to be a waiver or relinquishment of any such term or condition. The same shall be and remain in full force and effect unless there is a prior written waiver by the Department. Complete Statement of Terms The Contract constitutes the entire agreement between the parties hereto and shalt supersede all previous proposals, oral or written, negotiations, representations commitments, and other communications between the parties. The Contract may not be released, discharged, changed, extended, modified, subcontracted or assigned in whole or in part, and no claim for additional services not specificaiiy provided herein will be allowed by the Department, except to the extent provided by an instrument in writing signed by a duly authorized representative of the Department and the Contractor. J. Priority of Contract Documents The Contract consists of and precedence is established by the order of the following documents incorporated into this Contract: 1) the Attachments identified on the Contract Cover Sheet; 2) these General Terms and Conditions; and, 3) the Contract Cover Sheet. These documents are complementary and what is required by one shall be binding as if required by alt. in the case of any conflict or inconsistency arising under the documents, a higher priority document shall supersede a lower priority document to the extent necessary to resolve any such conflict or inconsistency. No conflict or inconsistency shall be deemed to occur in the event an issue is addressed in one of the above mentioned documents but is not addressed in another of such documents. No conflict or inconsistency shall be deemed to occur in the event an issue addressed in one of the above mentioned documents is an additional or supplemental requirement to an issue addressed in another of such documents. K. Severability if any term or provision of the Contract is held by the court to be illegal or unenforceable, the validity of the remaining terms and provisions shall not be affected, and the rights and obligations of the parties shall be construed and enforced as if the Contract did not contain the particular term or provision heid to be invalid. L. Headings The captions and headings contained herein are for convenience and reference and are not intended to define or limit the scope of any provision of the Contract. General Terms and Conditions Page 8 of 9 IN WITNESS WHEREOF, the parties have executed this agreement. CONTRACTOR: ROBERT WECHSLER, CONSULTANTS iN EPILEPSY NEUROLOGY, PLLC Name of Organization Mar wads/a Name of Signature Authority (printed) Title Signature Date Mailing Address: MM w. #an Telephone No. 75g" Contract Number: HCB66300 General Terms and Conditions STATE OF IDAHO: Department of Health and Welfare Name of Organization Etke Shaw-Tullooh, Division of Public Health Name of Signature Authority (printed) Division Administrator Title Signature Date Mailing Address: PO. Box 83720 Boise, ID 83720?0036 Telephone No. Page 9 of 9 Insurance For the term of the Contract and until all services specified in the Contract are completed, the Contractor shall maintain in force, at its own expense, the following insurance. a Commercial General Liability Insurance and, if necessary, Commercial Umbrella Liability insurance with a limit of not less than one million dollars ($1,000,000) each occurrence. Insurance required by this section shall name the State of idaho, Department of Health and Welfare as an additional insured. Automobile Liability Insurance and, if necessary, Umbrella Liability insurance with a limit of not less than one million dollars ($1,000,000) each accident. Insurance required by this section shall name the State of Idaho, Department of Health and Welfare as an additional insured. a Professional Liability insurance with a limit of not less than one million dollars ($1,000,000) each occurrence. If any of the liability insurance required for this contract is arranged on a "claims-made" basis, "tail coverage" will be required at the completion or termination of this contract for a duration of twenty?four (24) months thereafter. Continuous "claims-made" coverage will be acceptable in lieu of ?tail?coverage" provided the retroactive date is on or before the effective date of this contract, or twenty?four (24) months "prior acts" coverage is provided. Contractor will be responsible for furnishing certification of "tail coverage" or continuous "claims?made" coverage. Prior to performing any services, the Contractor shall provide certificates of insurance to the Department. The Contractor is also required to maintain current certificates on file with the Department and to provide updated certificates upon request. Failure to provide the required certificates of insurance shalt constitute a default under this Contract and upon such failure the Department may, at its option, terminate the Contract. insurance required by this section shall be policies or contracts of insurance issued by insurers approved by the Department. insurance certificates shall provide for thirty (30) days? prior written notice to the Department of cancellation or material change of such insurance. The Contractor shall further ensure that all policies of insurance are endorsed to read that any failure to comply with the reporting provisions of this insurance, except for the potential exhaustion of aggregate limits, shall not affect the coverage(s) provided to the State of idaho, Department of Health and Welfare. Please send updated certificates to: Idaho Department of Health and Welfare Contracting Procurement Services -- 9th Floor 450 West State Street Boise, ED 83702 Riders Page 1 of 2 Ownership Of Information The Department and the United States Department of Health and Human Services shail have unlimited rights to own, possess, use, disclose, transfer, or duplicate all information and data, copyrighted or otherwise, developed, derived, documented or furnished by the Contractor under the Contract. Riders Page 2 of 2 Scope of Work GENERAL REQUIREMENTS A. The Contractor shalt remain licensed by the idaho Board of Medicine to practice medicine in the State of idaho. B. The Contractor shail ensure procedural safeguards are followed in confidentiality requirements according to IDAPA 16.05.01, Use and Disclosure of Department Records. C. The Contractor shall receive prior written approval from the Department for any deviations from the contracted and budgeted services/activities. The Contractor shall be financially responsible for costs deemed unailowable or unapproved by the contract monitor. iI. CONTRACT SERVICES AND ACTIVITIES A. Submission of Appiication to the Division of Public Health?s Institutional Review Board. 1. The Contractor shall submit all required documentation for application for Institutional Review Board (IRB) approval to the idaho Division of Public Health?s Institutional Review Board by June 22, 2015, following the guidance and documents provided by the Division. 2. The Contractor shall respond within 5 working days to any inquiries or requests for additional information from the IRB, with the requested information, or an estimate of additional time needed. For requests requiring longer than 5 working days to fulfili, up to 1 week of additional time may be requested. 3. After the IRB has performed an initial review of the completed submission, the Contractor shall submit revised documentation as requested by the IRB until IRB approval for the Expanded Access Program (EAP) is received; the revised submission shall be submitted within 2 weeks of the request from the IRB. B. Submission of investigational New Drug (IND) protocoi to the federal Food and Drug Administration (FDA) and to GW Pharmaceuticals for approval. 1. The Contractor shall create an lNDciinicai protocoi that includes eligibility criteria, informed consent protocols, screening methods, treatment plan, data coliection, and medical follow-up, and submit the protocol to FDA and GW Pharmaceuticals for approval. C. Storage 1. The Contractor shall safely and securely store all documentation, medication, and ciinical samples related to the study. lli. REPORTS, RECORDS, AND DOCUMENTATION A. patient records shall be stored and transferred, if needed, in a HiPAA?compiiant manner. iV. QUALITY ASSURANCE A. The Contractor will document quaiity assurance through invoices and reports as outlined in the Reports section of this contract. Scope of Work Page 1 of 1 Performance Metrics Metric 1. Submission of application for Expanded Access Program to IRB Required Level of Expectation: 100% Method of Monitoring: Receipt of compieted application to Division of Pubiic Heaith?s Institutional Review Board by June 22, 2015. Strategy for Correcting Non-Compliance: Division of Public Health staff will work with the Contractor to determine barriers to submission. If Contractor is unable to meet expectations, reimbursement for uncompleted activities wili not be provided. Metric 2. Submission of revised application for Expanded Access Program to Required Level of Expectation: 100% Method of Monitoring: Receipt of revised or updated application by the Division of Pubiic Heaith's Institutional Review Board if requested, within 10 working days of request. Strategy for Correcting Non-Compliance: Division of Public Health staff will work with the Contractor to determine barriers to responding to request for a revised or updated application. If Contractor is unable to meet expectations, reimbursement for uncompleted activities wili not be provided. Metric 3. Submission of completed application to FDA and GW Pharmaceuticals. Required Level of Expectation: 100% Method of Monitoring: Receipt of completed clinical protocol and IND application to FDA and GW Pharmaceuticals within 10 working days after IRB approval. Strategy for Correcting Non-Compliance: Division of Public Heaith staff will work with the Contractor to determine barriers to submission to FDA. If Contractor is unable to meet expectations, reimbursement for uncompleted activities will not be provided. Performance Metrics Page 1 of Cost/Billing Procedure COST: The contract shail be a FEE, DEFINITE QUANTITY contract. The Department will pay the Contractor shaii receive up to the totai sum of EIGHT THOUSAND DOLLARS AND ZERO CENTS for services satisfactorily performed and authorized under the contract as defined in the matrix below. The amount for this contract shall only include the incurred costs directly related to the activities for this contract. Contract funds may not be used for construction, reimbursement of pre?contract costs, purchase of vehicles, or purchase of incentive items, uniess otherwise specified. Cost Matrix .. . . . i i I I 1 Submission of completed application for Epidioiex? Expanded Access $4 000 000 Program to Division of Public Health?s IRB Successful completion of IRB application process for Epidiolex? Expanded $1 000 00 Access Program Submission of ND clinical protocol application to FDA and GW Pharmaceuticals, and secure storage of relevant documentation, patient $3,000.00 samples, and Epidiolex? product MAXIMUM CONTRACT TOTAL $8,000.00 BILLING PROCEDURE: The Contractor shali submit an invoice for Activities listed under Section ILA of the Scope of Work. Invoices shall be submitted to the Department no later than August 30, 2015. The invoice shall include, but not be iimited to: 1. Ail contract services delivered during the billing period, identified by each item as reflected in the cost matrix, and the totaI for each. 2. Total amount billed for the billing period. 3. Contract number Contract Monitor: Christine Hahn Invoices shall be submitted montth to: Division of Public Health Attention: Nancy Panganiban idaho Department of Health and Weifare PO Box 83720 Boise ID 83720?0036 Invoices received without backup/supporting documentation or with errors will be returned to the Contractor for resubmission. Invoices will be processed for payment no later than thirty (30) calendar days once all required documentation is received. Invoices received without the required documentation will be returned to the Contractor for resubmission. No invoice snail be accepted or paid without required documentation. Procedure Page 1 of 1 STATE OF IDAHO Contract Amendment CONTRACT N0.: HC866300 CONTRACT AMENDMENT NO.: 1 FEDERAL I.D.NO.: 20216159600 CFDA NUMBER AND TITLE: DUNS NUMBER: This Contract Amendment is entered into by the State of Idaho, Department of Heaith and Weifare, hereinafter referred to as the DEPARTMENT, and ROBERT WECHSLER, MD I CONSULTANTS IN EPILEPSY NEUROLOGY, PLLC, hereinafter referred to as the CONTRACTOR. The effective date of the original contract was 07/01/2015. The expiration date of the contract as amended is 06/30/2016. ADDITIONAL Adding additional activities including enroiiment of eligible children. The following amended Attachments are hereby incorporated and made a part of this Agreement: Scope of Work Performance Metrics Cost/Billing Procedure Enrollment and Visit Documentation Form AMENDMENT AMOUNT $0.00 SUB OBJECT PROGRAM cosr ACCOUNT (PCA) 190% 12236 ALL DIV ADMIN) A19018 CONTRACT MONITOR: Christine Hahn CONTRACT MANAGER: Elke Shaw-Tulfoch CONTRACT AMENDMENT 1 Page 1 of2 THIS AGREEMENT is an amendment of the original contract between the Contractor and the Department. WHEREAS, the Department desires to amend the original contract and; WHEREAS, the Department is legally authorized to enter into this agreement by power granted by Title 56, Chapter 10, of the Idaho Code; and WHEREAS, the Contractor has been determined qualified and available to continue the provision of services for the time period covered by this Agreement; and The parties hereby agree that all other provisions of the original contract, with the exception of the amendments as provided herein, shall remain in force during the period covered by this Agreement. IN WITNESS WHEREOF, the parties have executed this agreement. CONTRACTOR: ROBERT WECHSLER, MD CONSULTANTS IN EPILEPSY NEUROLOGY, PLLC Name of Organization ?ow Name of Signature Authority (printed) 0W4 er Title 2; 2 Sig?rfa'tu re Date Mailing Address: W654 60,32, JD 287%, Jag?2.751356 Telephone No. Contract Number: H0866300 CONTRACT AMENDMENT 1 STATE OF IDAHO: Department of Health and Welfare Name of Organization Elke Shaw-Tulloch, Division of Public Health Name of Signature Authority (printed) Division Administrator Title Date Signature Mailing Address: PO. Box 83720 Boise, ID 83720?0036 Telephone No. Page 2 of2 Scope of Work Amendment 1 I. GENERAL A. The Contractor shall remain licensed by the Idaho Board of Medicine to practice medicine in the State of Idaho. B. The Contractor shall ensure procedural safeguards are followed in confidentiality requirements according to 16.05.01, Use and Disclosure of Department Records. C. The Contractor shall receive prior written approval from the Department for any deviations from the contracted and budgeted services/activities. The Contractor shalt be financially responsible for costs deemed unaiiowabie or unapproved by the contract monitor. ii. CONTRACT SERVICES AND A. Submission of Application to the Division of Public Health's Institutional Review Board. 1. The Contractor shall submit all required documentation for application for institutional Review Board approvat to the Idaho Division of Public Health's Institutionai Review Board by June 22, 2015, following the guidance and documents provided by the Division. 2. The Contractor shall respond within five (5) working days to any inquiries or requests for additionai information from the with the requested information, or an estimate of additional time needed. For requests requiring longer than five (5) working days to fulfill, up to one (1) week of additional time may be requested. 3. After the IRB has performed an initial review of the completed submission, the Contractor shall submit revised documentation as requested by the IRB until IRB approval for the Expanded Access Program (EAP) is received; the revised submission shall be submitted within two (2) weeks of the request from the B. Submission of lnvestigational New Drug protocol to the federal Food and Drug Administration (FDA) and to GW Pharmaceuticals for approval. 1. The Contractor shall create an iNDciinicai protocoi that inciudes eligibility criteria, informed consent protocols, screening methods, treatment plan, data coiiection, and medical follow?up, and submit the protocoi to FDA and GW Pharmaceuticals for approval. C. Storage 1. The Contractor shall safely and securely store all documentation, medication, and clinical samples reiated to the study. D. Screening and Enrollment . 1. The Contractor shall screen Idaho resident children referred by neurologists for eligibility into the Epidioiex Expanded Access Program and shall enroii up to twenty-five (25) of those eligible. 2. The Contractor shall assign a number for each enroiied child for use in the Enrollment and Visit Documentation Form, attached, and as a linking number for the "Screening Visit 1 form. 3. The Contractor shall submit documentation within forty?five (45) days after initial screening of each child and once twenty?five (25) children are enrolled, in the form of i) a copy of the first page of the "Screening Visit 1 form utilized in the application, with the child's number added to the page, and 2) the updated Enrollment and Visit Documentation Form (attached). Scope of Work Page 1 of 2 REPORTS, RECORDS. AND DOCUMENTATION i A. All patient records shalt be stored and transferred, if needed, in a HIPAA?compliant manner. tV. QUALITY ASSURANCE A. The Contractor will document quality assurance through invoices and reports as outlined in the Reports section of this contract. Scope of Work Page 2 of 2 Performance Metrics Amendment 1 Metric 1. Submission of application for Expanded Access Program to IRB Required Level of Expectation: 100% Method of Monitoring: Receipt of completed application to Division of Public Health's institutional Review Board by June 22, 2015. Strategy for Correcting Non-Compliance: Division of Pubiic Health staff wiil work with the Contractor to determine barriers to submission. if Contractor is unable to meet expectations, reimbursement for uncompieted activities wilt not be provided. Metric 2. Submission of revised application for Expanded Access Program to Required Level of Expectation: 100% Method of Monitoring: Receipt of revised or updated application by the Division of Public Health's institutional Review Board if requested, within 10 working days of request. Strategy for Correcting Non-Compliance: Division of Public Heaith staff work with the Contractor to determine barriers to responding to request for a revised or updated application. if Contractor is unable to meet expectations, reimbursement for uncompleted activities will not be provided. Metric 3. Submission of completed application to FDA and GW Pharmaceuticals. Required Level of Expectation: 100% Method of Monitoring: Receipt of completed clinical protocol and application to FDA and GW Pharmaceuticals within 10 working days after IRB approval. Strategy for Correcting Non-Compliance: Division of Public Health staff wilt work with the Contractor to determine barriers to submission to FDA. if Contractor is unable to meet expectations, reimbursement for uncompleted activities will not be provided. Metric 4 (Amd 11. Screening and enroliment of children into the EAP. Required Level of Expectation: 100% Method of Monitoring: Receipt of completed first page of "Screening Visit 1 form within forty?five (45) days after initial screening of each child, and Enroilment and Visit Documentation Form (attached). Once twenty-five (25) children are enrolled, receipt of the Enrollment and Visit Documentation Form Strategy for Correcting Non-Compliance: Division of Public Health staff wilt work with the Contractor to determine barriers to enrollment into the EAP and submission of Screening Visit 1 form or Report Form 1. if Contractor is unable to meet expectations, reimbursement for uncompieted activities not be provided. Performance Metrics Page 1 of 1 Cost/Billing Procedure Amendment 1 COST: The contract shall be a FIXED FEE, DEFINITE QUANTITY contract. The Department will pay and the Contractor shall receive up to the total sum of TWO HUNDRED THOUSAND HUNDRED DOLLARS AND ZERO CENTS for services satisfactorily performed and authorized under the contract as defined in the matrix below. The amount billed for this contract shall oniy include the incurred costs directly related to the activities for this contract. Contract funds may not be used for construction, reimbursement of pre?contract costs, purchase of vehicles, or purchase of incentive items, unless otherwise specified. Cost Matrix Original Contract Submission of completed application for Per Epidiolex? Expanded Access Program to Submission 1 $4,000.00 $4,000.00 Division of Public Health's Successful completion of RB application Per process for Epidiolex? Expanded Access Compie?on 1 $1,000.00 $1,000.00 Program Submission of IND clinical protocol application to FDA and GW Pharmaceuticals, and secure Per storage of all relevant documentation, patient Submission 1 $3'000'00 samples, and Epidiolex? product Original Contract Value $8,000.00 Cost Matrix Amendment 1 EAP coordinator, salary for nonclinical duties Per EAP including reporting to FDA and Coordinator 1 $3'000'00 Submission of confirmation of enroilment of Per 25 child into EAP as outlined in the SOW $3,500.00 $87,500.00 (maximum 25 children) SmeiSSEon (max'mum) Submission of confirmation of Visit Week 12 Per 25 via Report Form 1 as outiined in the SOW Submission (Maximum) $125'000'00 Amendment 1 Amount $215,500.00 MAXIMUM CONTRACT AMOUNT $223,500.00 PROCEDURE: The Contractor shall submit an invoice for Activities listed under Section l.A of the Scope of Work. invoices shall be submitted to the Department no later than July 28, 2016. Cost/Billing Procedure Page 1 of 2 The invoice shall include, but not be limited to: 1. 2. 3. 4 Contract Monitor: Ali contract services delivered during the billing period, identified by each item as reflected in the cost matrix, and the total for each. Totai amount billed for the billing period. Contract number Enrollment and Visit Documentation Form and "Screening Visit 1 form as indicated in the Scope of Work. Christine Hahn Invoices and accompanying documentation shall be submitted to: Division of Public Health Attention: Nancy Panganiban Idaho Department of Health and Welfare PO Box 83720 Boise ID 83720?0036 Invoices received without backup/supporting documentation or with errors wii! be returned to the Contractor for resubmission. Invoices be processed for payment no later than thirty (30) calendar days once all required documentation is received. will be returned to the Contractor for resubmission. Invoices received without the required documentation No invoice shall be accepted or paid without required documentation. Cost/Billing Procedure Page 2 of 2 Enrollment and Visit Documentation Form DATE SUBMITTED: Please indicate for EACH subject currently enrolled in the EAP which visits as outlined in the clinical protocol have been completed, by indicated with the date of the visit or contact in the appropriate box. Each submission of this form should include the previous form?s data with new visits indicated. i??i?A H0 12 m-iwaHommximm-hw Enrollment and Documentation Form Page 1 of 1 STATE OF IDAHO Contract Amendment CONTRACT NO.: HC866300 CONTRACT AMENDMENT NO.: 2 FEDERAL I.D.NO.: 20216159600 This Contract Amendment is entered into by the State of Idaho, Department of Health and Welfare, hereinafter referred to as the DEPARTMENT, and ROBERT WECHSLER, MD CONSULTANTS IN EPILEPSY NEUROLOGY, PLLC, hereinafter referred to as the CONTRACTOR. The effective date of the original contract was 07/01/2015. The expiration date of the contract as amended is 06/30/2017. ADDITIONAL Extending current contract for an additional year. The following amended Attachments are hereby incorporated and made a part of this Agreement: AMENDMENT AMOUNT $0.00 SUB OBJECT PROGRAM COST ACCOUNT (PCA) 100% 12236 ALL DIV ADMIN) A19018 CONTRACT MONITOR: Christine Hahn CONTRACT MANAGER: Elke Shaw-Tuiloch Contract Amendment 2 Page 1 of2 THIS AGREEMENT is an amendment of the original contract between the Contractor and the Department. WHEREAS, the Department desires to amend the original contract and; WHEREAS, the Department is legally authorized to enter into this agreement by power granted by Title 56, Chapter 10, of the Idaho Code; and WHEREAS, the Contractor has been determined qualified and available to continue the provision of services for the time period covered by this Agreement; and The parties hereby agree that all other provisions of the original contract, with the exception of the amendments as provided herein, shall remain in force during the period covered by this Agreement. IN WITNESS WHEREOF, the Department and the Contractor have executed this Agreement. CONTRACTOR: STATE OF IDAHO: GAIM Department of Health and Welfare Name of Organization Name of Organization wake Shaw?Tulloch, Division of Public Health Name of Signature Authority (printed) Name of Signature Authority (printed) 04/4 0" Division Administrator We K. Signature Date Date 3/5?f/L Mailing Address: Mailing Address: PO. Box 83720 4302.512 J5 ??702/ Boise, ID 83720?0036 we f@ we. Com Email Address Telephone No. Telephone No. Contract Number: H0866300 Contract Amendment 2 Page 2 of 2