Attachment A-LABORATORY SERVICES AGREEMENT

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Attachment A- LABORATORY SERVICES AGREEMENT THIS SERVICES AGREEMENT (the ''Agreement"), effective on the _29_ 1 h day of April, 2020 ("Effective Date"), is by and between PATRIOT MEDICAL LABORATORIES, LLC dba ClAN DIAGNOSTICS ("ClAN") and MARYLAND DEPARTMENT OF HEALTH ("MDH"). For valuable consideration, ClAN and MDH hereby agree as follows: 1 SERVICES Ll ClAN will provide clinical laboratory testing services as set forth in Attachment A ("Laboratory Services") and will provide reports back to the MDH in a murua ll y agreed upon electronic format. ClAN will perfonn a bridging study between its cmTcnt Food and Drug Administration ("FDA") Emergency Use-Authorized ("EUA") method using TaqPath RT-PCR COVID-19 kit and the LabGenomics LabGun Covid-19 Assay PCR Kit for SARS-Co V-2 testing and provide the report to MDH at no cost. 1.2 MDH agrees that: Chain-of-custody of test samples arc excluded from this Agreement. All Laboratory Services will be ordered by person(s) who are authorized under Maryland state and/or federal law to order laboratory tests. MDH will utilize appropriate oral or nasopharyngeal swab for each specimen and provide adequate quantity, and ensure that specimens are properly processed, and arc properly packaged for transpor t. Cl AN will provide to MDH the appropriate FDA-approved nasopharyngeal swabs and Viral Transport Media for specimen collection by MDH. The swabs provided by ClAN will be FDA-approved or FDA-authorized under EUA. ClAN is not required to provide or arrange for Laboratory Services that arc not listed on Attachment A. MDH will pro vide personnel and personal protective equipment (PPE) necessary for sample collection at various locations in the State of Maryland. ClAN Diagnostics shall provide a courier service, and in accordance with MDH's instructions distribute and pick up specimens 7 days a week at no cost. The specimens shall be picked up from any specimen collection location in the state or any designated location. ClAN Diagnostics shall deliver specimen collection kits to each specimen collection location in the state or any designated location on a daily basis within 8 hours. 1

Transcript of Attachment A-LABORATORY SERVICES AGREEMENT

Page 1: Attachment A-LABORATORY SERVICES AGREEMENT

Attachment A- LABORATORY SERVICES AGREEMENT

THIS SERVICES AGREEMENT (the ''Agreement"), effective on the _29_1h day of

April, 2020 ("Effective Date"), is by and between PATRIOT MEDICAL LABORATORIES, LLC dba ClAN DIAGNOSTICS ("ClAN") and MARYLAND DEPARTMENT OF HEALTH ("MDH").

For valuable consideration, ClAN and MDH hereby agree as follows:

1 SERVICES

Ll ClAN will provide clinical laboratory testing services as set forth in Attachment A ("Laboratory Services") and will provide reports back to the MDH in a murually agreed upon electronic format.

• ClAN will perfonn a bridging study between its cmTcnt Food and Drug Administration ("FDA") Emergency Use-Authorized ("EUA") method using TaqPath RT-PCR COVID-19 kit and the LabGenomics LabGun Covid-19 Assay PCR Kit for SARS-Co V -2 testing and provide the report to MDH at no cost.

1.2 MDH agrees that: • Chain-of-custody of test samples arc excluded from this Agreement.

• All Laboratory Services will be ordered by person(s) who are authorized under Maryland state and/or federal law to order laboratory tests.

• MDH will utilize appropriate oral or nasopharyngeal swab for each specimen and provide adequate quantity, and ensure that specimens are properly processed, and arc properly packaged for transport.

• ClAN will provide to MDH the appropriate FDA-approved nasopharyngeal swabs and Viral Transport Media for specimen collection by MDH.

• The swabs provided by ClAN will be FDA-approved or FDA-authorized under EUA.

• ClAN is not required to provide or arrange for Laboratory Services that arc not listed on Attachment A.

• MDH will provide personnel and personal protective equipment (PPE) necessary for sample collection at various locations in the State of Maryland.

• ClAN Diagnostics shall provide a courier service, and in accordance with MDH's instructions distribute and pick up specimens 7 days a week at no cost. The specimens shall be picked up from any specimen collection location in the state or any designated location.

• ClAN Diagnostics shall deliver specimen collection kits to each specimen collection location in the state or any designated location on a daily basis within 8 hours.

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• All requisition forms will be either provided by ClAN and such forms may be customized at the request ofMDH or ClAN will utilize the current MDH test requisition fonns

1.3 ClAN represents and warrants that:

• It complies with the licensing and certification requirements under the Clinical Laboratory Improvement Amendments of 1988 as amended ("CLlA"), the Medicare and Medicaid programs, and any other applicable federal and state statutes and regulations. It is further agreed that upon request ofMDH, ClAN will provide verification of such licensure.

• It is a duly organized clinical laboratory meeting all appropriate state and federal licensing requirements as a High Complexity Laboratory and is authorized by the FDA under EUA (emergency usc authorization) to perfom1 COVID-19 RT-PCR Test for SARS-CoV-2 using a real-time reverse transcription polymerase chain reaction (RT -PCR) test.

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COMPENSATION

ClAN will invoice MDI-I, o r its designated representative, at the fees set forth in Attachment A, attached hereto. To the extent MDH orders a Laboratory Service not listed on Attachment A, ClAN may perfom1 such testing at ClAN's standard list price until such

time as the parties mutually agree upon a negotiated fee for such testing. Notwithstanding the foregoing. in the event MDH orders a Laboratory Service not listed on Attachment A which (a) utilizes new technology: (b) is a new test not previously made widely available or requires the payment of a license or royalty: or (c) is a Laboratory Service that ClAN considers proprietary to it, ClAN may elect not to perfonn such Laboratory Service and

MDH shall not thereafter place orders for such test until the parties mutually agree

othen.vise.

ClAN will make available FDA-approved nasopharyngeal swabs and Viral Transport Media for a minimum of t,600 samples per day for seven (7) days per week for a period of three (3) months. ClAN represents that it has the capability to test the same number of samples during this period. Payment will be based on actual tests perfom1ed.

Except as otherwise provided in this Agreement, MDH agrees to pay ClAN by check, ACH transfer or electronic wire transfer or other fonn of payment method approved by

MDH, \\'ithin five (5) days of the date of each ClAN invoice for Laboratory Services, after which any unpaid invoice amounts shall be overdue. Interest on late payments shall be

governed by Md. State Finance and Procurement, Section 15-104. C lAN will invoice MDH every Monday for the sample rcpot1s released in the previous week for the duration of this Agreement.

All the payments for the tests performed to be deposited into First United Bank

and Trust, l 02 Baughmans Lane, Frederick, MD 21702~ Beneficiary- Patriot Medical Laboratories, LLC dba CIAN Diagnostics. Routing Number: 052 I 00987, Account# 912261743.

Unless this Agreement is terminated earlier pursuant to Section 4, all pricing contained

herein and attached hereto as Attachment A shall be in effect for three (3) months from the Effective Date.

This contract automatically renews for another term of 3 months unless tenninated by either party with a written notice to the other party 15 days before the end of the contract.

RESULTS. RECORDS AND LABORATORY DATA

For each order of Laboratory Services pcrfom1cd, ClAN will provide a written or electronic Test Report that includes results of the test and comments deemed necessary by MDH. ClAN has a special license for the productions of swabs and they are considered a proprietary product. MDH may not sell, transfer, give or distribute ClAN's swabs to any other laboratory, vendor, company or non-ClAN entity. After samples are taken, the swabs must be returned in the same number for testing at ClAN's laboratory. The parties

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will reconcile the swab count on a weekly basis. Upon termination of this A!,rreement, MDH must return any unused swabs to ClAN.

4 TERM AND TERMINATION

4.1 The initial tem1 of this Agreement shall commence on the Effective Date and continue for a period of three (3) months unless earlier tenninatcd in the manner set forth below.

4.2 Either party may, upon \vritten notice to the other party. immediately terminate this Agreement upon the occurrence of any of the following events: a. ClAN is excluded from participating in any federally-funded program b. A loss of state licensure by ClAN that renders it unable to perform its obligations

under this Agreement. c. ClAN' s FDA EUA is terminated or revoked.

4.3 Either party may, upon w1itten notice to the other party, tcnninate this Agreement upon the occun·ence of any of the following events, with the defaulting party having a seven (7) day period to cure such default: a. Nonpayment by MDH for 30 days after submittal of the invoice by ClAN. b. C lAN does not make available FDA-approved nasopharyngeal swabs and Viral

Transport Media for 1600 samples per day. c. ClAN is not able to process and obtain results for 1600 samples per day. d. Usc of C lAN's FDA-approved nasopharyngeal swabs and Viral Transport Media by

MDH for tests sent to non-ClAN laboratories. e. The aggregate number of test samples sent by MDH to ClAN in any 30-day period

during the tcm1 of this Agreement is less than 40,000. f. MDH determines that changes in the current state of emergency watTaot a significant

change in the state's need for COVID-1 9 testing.

4.4 Upon termination of this Agreement, neither party shall have any further obligation or liability hereunder with the exception of(i) obligations accming prior to the date of termination, such as completion of testing in progress and payment for Laboratory Services rendered prior to the termination of this Agreement at the rates set forth in this Agreement, (ii) payment of Laboratory Services rendered after the tennination of the Agreement shall be at ClAN's billed charges, and (iii) obligations, promises or covenants contained herein that expressly survive the tennination of this Agreement. Notwithstanding the above, the parties agree to use reasonable efforts to mitigate damages.

5 INSURANCE

ClAN agrees to maintain general and professional liability insurance in minimum amounts of S 1,000,000 per claim and $2,000,000 annual aggregate. ClAN agrees to furnish MDH upon request with a current and valid Certificate of Insurance, evidencing their general and

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professional liability insurance coverage. Any material modification, alteration or cance1lation in such coverage shall be promptly communicated to the MDH and ClAN shall secure replacement coverage meeting the requirements hereunder so as to ensure no lapse in coverage. The provisions of this section shall survive termination of this Agreement.

6 INDEPEND.ENT CONTRACTOR

It is understood that ClAN's services hereunder are to be rendered in the capacity of an independent contractor of MDH. Neither party has authority to enter into contracts or assume any obligations for or on behalf of the other party or to make any warranties or representations for or on behalf of the other party.

7 CONFJDE~TIALITY

All terms of this Agreement (including without limitation the pricing provisions) and information or data relating to the business or operations of any party to this Agreement acquired by any other party hereto in connection \Vith this Agreement shall be treated as strictly confidential by the receiving party, and shall not, unless othenvise required by law or the requirements of any accrediting agency, be disclosed by the receiving party without the prior written permission of the party hereto to whom the infonnation in question relates. This provision shall survive termination of this Agreement.

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8 MISCELLANEOUS

8.1 Any notice required to be given hereunder will be deemed to have been served properly, if mailed by certified or registered mail, postage prepaid (or Federal Express or equivalent courier), properly addressed and posted in a United States depository to the respective parties at the addresses set forth under their signature.

8.2 The individuals signing this Agreement represent that they have the auth01ity to sign this Agreement on behalf of the respective parties.

8.3 ClAN represents and warrants that it has not been convicted of a crime related to healthcare or is not currently listed by a federal agency as debarred or excluded from participation in federally funded programs (including, without limitation, federally funded healthcare programs, such as Medicare and Medicaid).

8.4 If any provision of this Agreement is determined to be illegal, invalid or unenforceable by a court of competent jurisdiction, the pat1.ies shall endeavor in good faith to negotiate legal, valid and enforceable substitute provisions that fulfill as closely as possible the original intents and purposes of the Agreement. The remaining portions of the Agreement not declared illegal, invalid, or unenforceable shall remain in full force and effect only if the essential terms and conditions of this Agreement for each party remain valid, binding and enforceable and the economic and legal substance of the transactions contemplated by the Agreement are materially preserved for t!ach party.

8.5 This Agreement shall not be assigned, delegated, or transferred by either party without the written consent of the other party, which consent shall not be unreasonably withheld or delayed. Notwithstanding the foregoing, CIAN may refer work to an affiliated testing facility or to subcontracted providers without prior written consent. In addition, MDH acknowledges that certain testing may be performed and billed directly to MDH by ClAN 's affiliated testing laboratories. This Agreement is intended to inure only to the benefit ofMDH and ClAN.

9 EXCLUSION OF CERTAIN DAMAGES/FORCE MAJEURE

In no event shall either party or its respective officers, directors, employees, agents or affiliates be liable for any special, exemplary, incidental, consequential or punitive damages, whether in contract, warranty, tort, strict liability or otherwise. These limitations shall apply notwithstanding any failure of essential purposes of any limited remedy and shall survive termination of this Agreement.

No party to this Agreement shall be liable for failure to perform any duty or obligation that said party may have under the Agreement where such failure has been caused by any event, foreseen or unforeseen, outside the reasonable control of the party who had the duty to perfOJm and that renders performance impossible or impracticable, including, but not limited to, acts of God, terrorist acts, tire, strike, inevitable accident, war, plague or any other event, like or unlike those listed above (collectively, "Force Majeure Event"), but only to the extent prevented by the Force Majeure Event.

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Jn the event that there is a shortage of supplies required for performing Laboratory Services, suppliers increase costs of reagents of other supplies, or a license or other fee is required to be paid in connection with performing a Laboratory Service, ClAN shall advise MDH and, after no more than a thirty (30) day period of active good faith negotiation between MDH and ClAN, the fee set forth on Attachment A shall be amended to adj ust for any unanticipated increase in costs incun·ed by ClAN.

10 COMPLIANCE WITH LAWS

Each of the parties represents and warrants to the other party that it will comply with all applicable laws, rules or regulations ("Applicable Laws") as they may be amended from time to time. Applicable Laws include, but are not limited to, the Clinical Laboratory Improvement Amendments of 1988 as amended ("CLIA"), the federal Physician Self-Referral Law, 42 U.S.C. 1395nn, and rhc regulations promulgated thereunder (together, the "Stark Law"), similar state physician self-referral laws and regulations (together with the Stark Law, the "Self-Referral Laws"), the federal Medicare/T'v1edicaid Anti-kickback Law and regulations promulgated thereunder (the "Federal Anti-kickback Law") and similar state Anti-kickback laws and regulations (together with the Federal Anti-kickback Law, the "Anti-kickback Laws") and the data privacy and security requirements of Health Insurance Portability and Accountability Act of 1996 and regulations promulgated thereunder ("HIPAA"). This Agreement shall be governed and construed and enforced in accordance with the laws of the State of Maryland. This paragraph wi ll surv ive the termination or expiration of this Agreement to the extent that the Applicable Laws pertain to ongoing obligations of a party under this Agreement.

12 NOTICE ADDRESSES:

To Maryland Department of Health:

To ClAN Diagnostics:

Dana Dembrow Director, Office of Procurement and Support Services 20 J W. Preston Street. Room 416 Baltimore. MD 21201

Sombabu Mullapudi 5330 Spectrum Drive. Suite l Frederick, MD 21703

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May 2, 2020

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ATTACHMENT A -PRICING

COVID-19 RT-PCR Test for SARS-CoV-2 virus using labGun Covid-19 Assay PCR Kit for SARS­CoV-2 testing - $98.00 per sample with the testing kits provided by the Maryland Department of Health at no cost to ClAN

COVID-19 RT-PCR Test for SARS-CoV-2 virus using real-time reverse transcription polymerase chain reaction (RT -PCR) test- $98.00 per sample using any other testing kits such as Thermo TaqPath COVID viral Assay or similar kits which are permitted by the FDA EUA authorization

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