By checking the box, the “Client,” whose details are provided in the Order Form, enters into this Master Testing Services Agreement (“Agreement”) with Cardio Diagnostics, Inc., a Delaware corporation located at 311 W Superior Street, Suite 444, Chicago, IL 60654 (“Cardio”). The effective date of this Agreement is the date the box is checked. “Client” and together with “Cardio”, the “Parties” and each a “Party”. The Parties agree as follows:
Recitals
Cardio offers Epi+Gen CHD and PrecisionCHD precision heart disease tests, HeartRisk cardiovascular disease risk intelligence platform, and has the capability and capacity to provide certain diagnostic testing services described in this Agreement; and
Client desires to provide its eligible patients with access to Epi+Gen CHD as part of their annual benefits as part of ensuring innovative cardiovascular care in its practice, provide its eligible patients with access to PrecisionCHD when applicable, retain Cardio to deliver the services, and Cardio is willing to perform such services under the terms and conditions in this Agreement;
NOW, THEREFORE, in consideration of the mutual covenants and agreements outlined in this Agreement and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:
- Services:
- Cardio Diagnostics agrees to provide, on a non-exclusive basis, Epi+Gen CHD and PrecisionCHD precision heart disease tests (the “Services”) to Client’s eligible patients as set out in Test Requisition Forms and accepted by Cardio (each a “Test Requisition Form”).
- Eligibility:
- Eligibility for the tests will be determined by Client in accordance with its clinical judgement, patients’ policies and guidelines.
- Cardio’s Obligations:
- Cardio shall:
- Respond promptly to any reasonable request from Client for instructions, information, or approvals required by Client in connection with receiving the Services.
- Ensure that its turn-around time for delivering laboratory test result reports to Client shall not exceed 10 business days from the time of receipt of a properly collected and packaged patient sample at Cardio’s designated laboratory at least 90% of the time, measured on a rolling twelve (12) month basis. If there is a delay in reported results or additional testing is required to confirm or clarify the result of a specific test or sample, and the additional testing cannot be performed within the applicable turn-around time, Cardio shall notify Client when results will be available.
- Cooperate with Client with respect to the performance of the Services.
- Abide by the terms and conditions attached hereto as Exhibit A and incorporated herein by reference (the “Terms and Conditions”).
- Client’s Obligations:
- Client shall:
- Respond promptly to any reasonable requests from Cardio for instructions, information, or approvals required by Cardio to provide the Services.
- Collect a viable patient sample and provide necessary patient information including date of birth, collection date, collection time and sex on the biohazard bag.
- Collect a minimum of 2 milliliters or 500 microliters of blood for vacutainer or microtainer tubes, respectively.
- Store sample between 4 degrees Celsius and room temperature, and ship the sample to Cardio’s designated laboratory using the provided return shipment materials the same day of collecting the patient’s blood.
- Require the individuals from which Client will obtain samples to review and execute the appropriate HIPAA releases and consent forms.
- Cooperate with Cardio in its performance of the Services and provide access to Client’s employees, premises, patients, contractors, and equipment as required to enable Cardio to provide the Services.
- Take all steps necessary, including obtaining and paying for any required licenses, consents, or permits necessary or required for Cardio’s provision of the Services to Client.
- Notify Cardio of any complaint within twenty-four (24) hours of occurrence. Any complaint not provided within such time shall be deemed a waiver by Client and acceptance of the Services.
- Abide by the Terms and Conditions.
- Fees and Expenses:
- In consideration of the provision of the Services by Cardio and the rights granted to Client under this Agreement, Client shall pay $350 per Epi+Gen CHD test and $850 per PrecisionCHD test (the “Fees”). Invoices for testing services will be payable by Client within thirty (30) days of receiving an invoice from Cardio.
- Cardio reserves the right to charge a sample collection kit replacement fee of up to $100 per kit solely at its discretion if a collection kit is made available to the Client’s patients at home.
- Cardio reserves the right to modify its Fees at any time, provided Client has thirty (30) days written notice.
- Client shall be responsible for all sales, use and excise taxes, and any other similar taxes, duties and charges of any kind imposed by any federal, state or local governmental entity on any amounts payable by Client hereunder; provided, that, in no event shall Client pay or be responsible for any taxes imposed on, or regarding, Cardio’s income, revenues, gross receipts, personnel, or real or personal property or other assets.
- Except for invoiced payments that Client has successfully disputed, all late payments shall bear interest at the lesser of (a) the rate of 4% per month and (b) the highest rate permissible under applicable law, calculated daily and compounded monthly. Client shall also reimburse Cardio for all reasonable costs incurred in collecting any late payments, including, without limitation, attorneys’ fees. In addition to all other remedies available under this Agreement or at law (which Cardio does not waive by the exercise of any rights hereunder), Cardio shall be entitled to suspend the provision of any Services if Client fails to pay any fees when due under this Agreement.
- Term, Termination and Survival
- This Agreement shall commence as of the Effective Date and shall continue thereafter (the “Term”) unless terminated pursuant to Section 6.2 or Section 6.3.
- Either Party may terminate this Agreement, effective upon thirty (30) days written notice to the other Party (the “Defaulting Party”) if the Defaulting Party:
- Materially breaches this Agreement, and such breach is incapable of cure, or with respect to a material breach capable of cure, the Defaulting Party does not cure such breach within thirty (30) days after receipt of written notice of such breach.
- Becomes insolvent or admits its inability to pay its debts generally as they become due.
- Becomes subject, voluntarily or involuntarily, to any proceeding under any domestic or foreign bankruptcy or insolvency law, which is not fully stayed within seven (7) business days or is not dismissed or vacated within forty-five (45) days after filing.
- Is dissolved or liquidated or takes any corporate action for such purpose.
- Makes a general assignment for the benefit of creditors.
- Has a receiver, trustee, custodian, or similar agent appointed by order of any court of competent jurisdiction to take charge of or sell any material portion of its property or business.
- Notwithstanding anything to the contrary in Section 6.2(a), Cardio may terminate this Agreement on written notice if Client fails to pay any amount when due under this Agreement: (a) and such failure continues for ten (10) days after Cardio’s delivery of written notice of nonpayment; or (b) more than two (2) times in any six (6)-month period.
- Either Cardio or Client may terminate this Agreement on written notice pursuant to changes in Fees. 6.5 The rights and obligations of the Parties set forth in this Section 6 and in Terms and Conditions Sections 2, 3, 4, 5, 6, 7 and any right or obligation of the Parties in this Agreement which, by its nature, should survive termination or expiration of this Agreement, will survive any such termination or expiration of this Agreement.
Exhibit A: Terms and Conditions
- Intellectual Property
- All intellectual property rights, including copyrights, patents, patent disclosures and inventions (whether patentable or not), trademarks, service marks, trade secrets, know-how and other confidential information, trade dress, trade names, logos, corporate names and domain names, together with all of the goodwill associated therewith, derivative works, works developed by Cardio, its patients, agents, or affiliates while rendering the Services (related or unrelated thereto) and all other rights (collectively, “Intellectual Property Rights”) in and to all documents, work product and other materials that are delivered to Client under this Agreement or prepared by or on behalf of Cardio in the course of performing the Services, except for any Confidential Information of Client or Client materials shall be owned by Cardio.
- Cardio’s intellectual property includes HeartRiskTM, the cardiovascular risk intelligence platform that presents risk across , including drivers of heart disease, population cardiovascular disease statistics, cardiovascular risk distribution among lives, segmentation, claims analysis, and spend analysis.
- Client grants to Cardio a perpetual non-exclusive, worldwide, royalty free, license to use of Client’s name, domain name(s), logo, trademark, service mark, for the sole purpose of Cardio publicizing its portfolio of clients and examples of its work-product and services to others (“Cardio Client Portfolio Reference”).
- Confidentiality
- From time to time during the Term of this Agreement, either Party (as the “Disclosing Party”) may disclose or make available to the other Party (as the “Receiving Party”), nonpublic, proprietary, and confidential information of Disclosing Party, including, but not limited to, organizational information, marketing plans, financial information, and information regarding clients, vendors, suppliers, and employees (“Confidential Information”); provided, however, that Confidential Information does not include any information that: (a) is or becomes generally available to the public other than as a result of Receiving Party’s breach of this Section 2; (b) is or becomes available to the Receiving Party on a non-confidential basis from a third-party source, provided that such third party is not and was not prohibited from disclosing such Confidential Information; (c) was in Receiving Party’s Group (as defined below) possession prior to Disclosing Party’s disclosure under this Agreement; (d) was or is independently developed by Receiving Party without using any Confidential Information; or (e) is required to be disclosed in accordance with law or court order.
- The Receiving Party shall: (a) protect and safeguard the confidentiality of the Disclosing Party’s Confidential Information with at least the same degree of care as the Receiving Party’s Group would protect its own Confidential Information, but in no event with less than a commercially reasonable degree of care; (b) not use the Disclosing Party’s Confidential Information, or permit it to be accessed or used, for any purpose other than to exercise its rights or perform its obligations under this Agreement; and (c) not disclose any such Confidential Information to any person or entity, except to the Receiving Party’s representatives who need to know the Confidential Information to assist the Receiving Party, or act on its behalf, to exercise its rights or perform its obligations under this Agreement.
- If the Receiving Party is required by applicable law or legal process to disclose any Confidential Information, it shall, prior to making such disclosure, use commercially reasonable efforts to notify Disclosing Party of such requirements to afford Disclosing Party the opportunity to seek, at Disclosing Party’s sole cost and expense, a protective order or other remedy.
- For purposes of this Section 2 only, Receiving Party’s Group shall mean the Receiving Party’s affiliates and its or their employees, officers, directors, shareholders, partners, employees, managers, agents, independent contractors, service providers, sublicensees, subcontractors, attorneys, accountants, and financial advisors.
- Each Receiving Party shall promptly return all Confidential Information of the other Party it holds in written form and all copies of it upon the Disclosing Party’s written demand, except for Confidential Information that may be incorporated in any information that the Receiving Party is required to maintain by law to verify the work that it performed, which may be retained by such Party subject to the restrictions contained in this Section.
- LIMITATION OF LIABILITY
- EXCEPT AS PROVIDED HEREIN, CARDIO MAKES NO WARRANTIES. ALL WARRANTIES, EXPRESS AND IMPLIED, ARE EXPRESSLY DISCLAIMED.
- IN THE EVENT THAT CARDIO FAILS TO PERFORM UNDER THIS AGREEMENT, THEN CLIENT SHALL FIRST SEEK TO OBTAIN A RECOVERY FROM CARDIO’S INSURANCE POLICIES PRIOR TO MAKING OR ISSUING A CLAIM AGAINST CARDIO. HOWEVER, IN NO EVENT SHALL CARDIO BE LIABLE TO CLIENT OR TO ANY THIRD PARTY FOR ANY LOSS OF USE, REVENUE, OR PROFIT OR LOSS OF DATA OR DIMINUTION IN VALUE, OR FOR ANY CONSEQUENTIAL, INCIDENTAL, INDIRECT, EXEMPLARY, SPECIAL, OR PUNITIVE DAMAGES WHETHER ARISING OUT OF BREACH OF CONTRACT, TORT (INCLUDING NEGLIGENCE), OR OTHERWISE, REGARDLESS OF WHETHER SUCH DAMAGE WAS FORESEEABLE AND WHETHER OR NOT CARDIO HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, AND NOTWITHSTANDING THE FAILURE OF ANY AGREED OR OTHER REMEDY OF ITS ESSENTIAL PURPOSE.
- IN NO EVENT SHALL CARDIO’S AGGREGATE LIABILITY ARISING OUT OF OR RELATED TO THIS AGREEMENT, WHETHER ARISING OUT OF OR RELATED TO BREACH OF CONTRACT, TORT (INCLUDING NEGLIGENCE), OR OTHERWISE, EXCEED THE FEES ACTUALLY PAID TO CARDIO DIAGNOSTICS PURSUANT TO THE APPLICABLE TO THE TERMS OF THE AGREEMENT, PROVIDED SUCH AGREEMENT WAS ENTERED INTO IN THE 12-MONTH PERIOD PRECEDING THE EVENT GIVING RISE TO THE CLAIM.
- Regulatory Compliance; Disclaimer
- Compliance with Law/Material Breach. Each Party represents and warrants that in the performance of its obligations under this Agreement, it will comply with all applicable laws, rules, or regulations that pertain to its business operations and to this Agreement (“Applicable Laws”). Failure by either Party to comply with any Applicable Law as required by this Agreement shall be considered a material breach of this Agreement. In the event of a determination that this Agreement is not in compliance with any Applicable Law, then the Parties shall negotiate in good faith to bring this Agreement into compliance.
- HIPAA/FERPA Compliance. Each Party represents and warrants that it shall protect the privacy, integrity, security, confidentiality and availability of the protected health information disclosed to, used by, or exchanged by the Parties by implementing and maintaining privacy and security policies, procedures, and practices, and administrative, physical and technological safeguards and security mechanisms that reasonably and adequately protect the confidentiality, integrity and availability of the protected health information created, received, maintained or transmitted under this Agreement, all as required by, and set forth more specifically in, the Health Insurance Portability and Accountability Act of 1996 (HIPAA) or related privacy regulations, as applicable, and Exponential represents and warrants that it shall further comply with the Family Educational Rights and Privacy Act (FERPA), as, in each case, may be amended from time to time. In the event HIPAA or FERPA or other the privacy regulations or security regulations require any addition to or modification of this Agreement, the Parties shall use commercially reasonable efforts to agree upon such additions or modifications in a timely manner. If such agreement cannot be reached in a timely manner, either Party may terminate this Agreement by written notice to the other Party.
- Disclaimer. This test should be interpreted by the patient’s healthcare provider within the appropriate clinical context and in conjunction with all other relevant information. There is no guarantee of clinical benefit. Cardio makes no promises nor guarantees of testing cost reimbursement from any healthcare provider, insurer, or other third-party payer. This test report does not replace genetic evaluation and comprehensive genetic testing if an inherited condition is suspected. A referral should be made to genetic counseling if clinically warranted. This assay was developed, and its performance characteristics determined by Cardio. It has not been cleared nor approved by the United States Food and Drug Administration (FDA). This test should be used for clinical purposes and should not be regarded as investigational or for research purposes only. The FDA does not require this test to go through premarket FDA review. Cardio’s clinical reference laboratory is certified under the Clinical Laboratory Improvement Amendments (CLIA) as qualified to perform high-complexity clinical laboratory testing (CLIA#26D2099356).
- Entire Agreement
- This Agreement, including and together with any related Orders, exhibits, schedules, attachments and appendices, constitutes the sole and entire agreement of the Parties with respect to the subject matter contained herein, and supersedes all prior and contemporaneous understandings, agreements, representations and warranties, both written and oral, regarding such subject matter. The Parties acknowledge that this Agreement supersedes and replaces all previous oral or written agreements, memoranda, correspondence or other communications between the Parties hereto relating to the Services.
- Notices
- All notices, requests, consents, claims, demands, waivers and other communications under this Agreement (each, a “Notice”, and with the correlative meaning “Notify”) must be in writing and if addressed to Cardio at its address set forth above and if addressed to Client at the address set forth on the Cardio account setup system (or to such other address or email address that the receiving Party may designate from time to time in accordance with this Section). Unless otherwise agreed herein, all Notices must be delivered by personal delivery, nationally recognized overnight courier or certified or registered mail (in each case, return receipt requested, postage prepaid). Except as otherwise provided in this Agreement, a Notice is effective only (a) on receipt by the receiving Party; and (b) if the Party giving the Notice has complied with the requirements of this Section 6.
- Severability
- If any term or provision of this Agreement is found by a court of competent jurisdiction to be invalid, illegal or unenforceable in any jurisdiction, such invalidity, illegality or unenforceability shall not affect any other term or provision of this Agreement or invalidate or render unenforceable such term or provision in any other jurisdiction. Upon a determination that any term or provision is invalid, illegal or unenforceable, the Parties shall negotiate in good faith to modify this Agreement to affect the original intent of the Parties as closely as possible in order that the transactions contemplated by this Agreement be consummated as originally contemplated to the greatest extent possible.
- Amendments
- No amendment to or modification, rescission, termination or discharge of this Agreement is effective unless it is in writing and signed by an authorized representative of each Party.
- Waiver
- No waiver by any Party of any of the provisions of this Agreement shall be effective unless explicitly set forth in writing and signed by the Party so waiving. Except as otherwise set forth in this Agreement, no failure to exercise, or delay in exercising, any right, remedy, power or privilege arising from this Agreement shall operate or be construed as a waiver thereof, nor shall any single or partial exercise of any right, remedy, power or privilege hereunder preclude any other or further exercise thereof or the exercise of any other right, remedy, power or privilege.
- Assignment
- Client shall not assign, transfer, delegate or subcontract any of its rights or delegate any of its obligations under this Agreement without the prior written consent of Cardio. Any purported assignment or delegation in violation of this Section 10shall be null and void. No assignment or delegation shall relieve the Client of any of its obligations under this Agreement. Cardio may assign any of its rights or delegate any of its obligations to any person, entity or organization acquiring all or substantially all of Cardio’s assets or more than fifty percent (50%) of the equity of Cardio without Client’s consent.
- Successors and Assigns
- This Agreement is binding on and inures to the benefit of the Parties and their respective permitted successors and permitted assigns.
- Relationship of the Parties
- The relationship between the Parties is that of independent contractors. The details of the method and manner for performance of the Services by Cardio shall be under its own control, Client being interested only in the results thereof. Cardio shall be solely responsible for supervising, controlling and directing the details and manner of the completion of the Services. Nothing in this Agreement shall give the Client the right to instruct, supervise, control, or direct the details and manner of the completion of the Services. The Services must meet the Client’s final approval and shall be subject to the Client’s general right of inspection throughout the performance of the Services and to secure satisfactory final completion. Nothing contained in this Agreement shall be construed as creating any agency, partnership, joint venture or other form of joint enterprise, employment or fiduciary relationship between the Parties, and neither Party shall have authority to contract for or bind the other Party in any manner whatsoever.
- No Third-Party Beneficiaries
- This Agreement benefits solely the Parties to this Agreement and their respective permitted successors and assigns and nothing in this Agreement, express or implied, confers on any other person, entity, or organization any legal or equitable right, benefit or remedy of any nature whatsoever under or by reason of this Agreement.
- Choice of Law
- This Agreement and all related documents, including all orders and exhibits attached to this Agreement, and all matters arising out of or relating to this Agreement, whether sounding in contract, tort, or statute, are governed by, and construed in accordance with, the laws of the State of Delaware, United States of America, without giving effect to the conflict of law provisions thereof to the extent such principles or rules would require or permit the application of the laws of any jurisdiction other than those of the State of Delaware.
- WAIVER OF JURY TRIAL
- EACH PARTY ACKNOWLEDGES THAT ANY CONTROVERSY THAT MAY ARISE UNDER THIS AGREEMENT, INCLUDING ORDERS, EXHIBITS, SCHEDULES, ATTACHMENTS, AND APPENDICES ATTACHED TO THIS AGREEMENT, IS LIKELY TO INVOLVE COMPLICATED AND DIFFICULT ISSUES AND, THEREFORE, EACH SUCH PARTY IRREVOCABLY AND UNCONDITIONALLY WAIVES ANY RIGHT IT MAY HAVE TO A TRIAL BY JURY IN RESPECT OF ANY LEGAL ACTION ARISING OUT OF OR RELATING TO THIS AGREEMENT, INCLUDING ANY ORDERS, EXHIBITS, SCHEDULES, ATTACHMENTS OR APPENDICES ATTACHED TO THIS AGREEMENT, OR THE TRANSACTIONS CONTEMPLATED HEREBY.
- Counterparts; Electronic Signatures
This Agreement may be executed in counterparts, each of which is deemed an original, but all of which together are deemed to be one and the same agreement. Notwithstanding anything to the contrary in Section 6, a signed copy of this Agreement by checking the box in the Order Form, delivered by facsimile, email, or other means of electronic transmission is deemed to have the same legal effect as delivery of an original signed copy of this Agreement. - Force Majeure
- Cardio shall not be liable or responsible to Client, nor be deemed to have defaulted or breached this Agreement, for any failure or delay in fulfilling or performing any term of this Agreement when and to the extent such failure or delay is caused by or results from acts or circumstances beyond the reasonable control of Cardio including, without limitation, acts of God, flood, fire, earthquake, explosion, governmental actions, war, invasion or hostilities (whether war is declared or not), terrorist threats or acts, riot, cybersecurity hacks or breaches or other civil unrest, national emergency, revolution, insurrection, epidemic, pandemic, lock-outs, strikes or other labor disputes (whether or not relating to either Party’s workforce), or restraints or delays affecting carriers or inability or delay in obtaining supplies of adequate or suitable materials, materials or telecommunication breakdown or power outage, provided that, if the event in question continues for a continuous period in excess of fourteen (14) days, Client shall be entitled to give notice in writing to Cardio to terminate this Agreement, but Client shall be responsible for payment of the Fees described in this Agreement without penalty and without any further obligation.