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HomeMy WebLinkAboutResolutions - 2017.08.23 - 23083MISCELLANEOUS RESOLUTION #17244 August 23, 2017 BY: Commissioner William Dwyer, Chairperson, Public Services Committee IN RE: DEPARTMENT OF PUBLIC SERVICES — MEDICAL EXAMINER'S OFFICE — AGREEMENT WITH ARCTURUS HEALTHCARE, PLC. To the Oakland County Board of Commissioners Chairperson, Ladies and Gentleman: WHEREAS the Oakland County Medical Examiner is required to investigate and determine the cause of death within the boundaries of Oakland County; and WHEREAS included in the required investigation is a thorough post mortem examination which analyzes the brain tissue to accurately determine the cause and manner of death; and WHEREAS Avid Radiopharmaceuticals, Inc, a wholly-owned subsidiary of Eli Lilly and Company, is conducting research on terminally ill patients with Alzheimer's disease; and WHEREAS Avid Radiopharmaceuticals, Inc. has entered into an agreement with specific patients to study the brain after post mortem examination; and WHEREAS Avid Radiopharmaceuticals, Inc. is requesting the Oakland County Medical Examiner to conduct cranial autopsies for selected patients of this study; and WHEREAS the Oakland County Medical Examiner and Avid Radiopharmaceuticals, Inc. have entered into a confidentiality agreement into the manner of the study; and WHEREAS Arcturus Healthcare, PLC is acting on behalf of Avid Radiopharmaceuticals, Inc. for Michigan case studies; and WHEREAS an agreement has been made with Arcturus Healthcare, PLC to reimburse for services to the Oakland County Medical Examiner according to the fee schedule; and WHEREAS the agreements to provide services have been approved through the County Executive review process. NOW THEREFORE BE IT RESOLVED that the Oakland County Board of Commissioners approves the request for the agreement between Arcturus Health Care, PLC. with the Oakland County Medical Examiner's Office. BE IT FURTHER RESOLVED that acceptance of this agreement does not obligate the County to any future commitment and continuation of the agreement. Chairperson, on behalf of the Public Services Committee, I move theaidbAjAn of the foregoing resolution. CoffirnVioner William Dwyer, District #14 Chairperson, Public Services Committee PUBLIC SERVICES COMMITTEE Motion carried unanimously on a roll call vote with Dwyer absent. ARCTURUS HEALTHCARE, PLC BUSINESS ASSOCIATE AGREEMENT THIS BUSINESS ASSOCIATE AGREEMENT (the "Agreement") is entered into effective as of the Effective Date, defined below, by and between, Arcturus Healthcare, PLC, a Michigan professional limited liability company (the "Covered Entity"), and Oakland County ("Business Associate"). A. Covered Entity is a "covered entity" for purposes of HIPAA, HITECH and the HIPAA Regulations, as defined below and Business Associate may be a "business associate'' of Covered Entity, B. As a condition to Covered Entity entering into a business relationship with Business Associate, and to the extent Business Associate is a "business associate" under the HIPAA Regulations, the parties desire to set forth in writing the terms and conditions applicable to the use and disclosure of Protected Health Information created, received, maintained or transmitted by Business Associate from or on behalf of Covered Entity. NOW, THEREFORE, the parties, intending to he legally bound but only to the extent Business Associate is a "business associate" under the HIPAA Regulations, agree as follows: Definitions. Except as otherwise specifically defined herein, the terms in this Agreement shall have the same meaning as set forth in the HIP AA Regulations. The following terms shall have the specific meanings set forth herein: (a) "Administrative, Physical and Technical Safeguards" means the standards and specifications for policies and practices as set forth in the H1PAA Regulations, (b) "Agreement" means this Business Associate Agreement (c) "Effective Date" means the effective date of the Services Agreement between the parties. (d) "HIPAA Regulations" means the privacy, breach notification, administrative simplification (transactions and code sets), and security regulations issued pursuant to the Health Insurance Portability and Accountability Act of 1996, Pub. L. No. 104. 191 ("H1PAA"), and the 'Health Information Technology for Economic and Clinical Health Act of 2009 ("HITECH"), and any other HIPAA or HITECH final regulations applicable to the Agreement, as those regulations exist from time to time and amendments thereto that are effective at any time during the Term of this Agreement (e) "Privacy Rule" shall mean the Standards for Privacy of Individually Identifiable Health Information at 45 CFR Part 160 and Part 164, as the same may be modified from time to time. (t) "Protected Health Information'', "PHI" and where applicable, Electronic Protected Health Information ("ePHI") shall have the same meaning as set forth in the HIPAA Regulations, limited to the information created, received, maintained or transmitted by Business Associate on behalf of Covered Entity, including (without limitation) such information that is transmitted to Business Associate by Covered Entity. (g) "Security Rule" shall mean the Security Standards at 45 CFR Parts 160, 162 and 164, as the same may be modified from time to time. (h) "Services Agreement" shall mean the agreement or agreements entered into between Business Associate and Covered Entity, pursuant to which Business Associate provides services that involve the use or disclosure of Protected Health Information, 2. Obligations and Activities of Business Associate. (a) Business Associate acknowledges that Business Associate is directly regulated by HIPAA and HITECH and subject to direct oversight and enforcement pursuant to those laws and associated regulations; and shall comply with their requirements, including but not limited to those requirements set forth in the HIPAA Regulations. 1. (b) Business Associate agrees to not use or disclose Protected Health Information other than as permitted or required by the Agreement or as required by law, and to do so at all times consistent with Covered Entity's minimum necessary policies and procedures. (c) Business Associate agrees to implement and use Administrative, Physical and Technical Safeguards ("Safeguards") that reasonably and appropriately prevent the use and disclosure of the PHI that Business Associate creates, receives, maintains or transmits on behalf of Covered Entity, comply with the Security Rule with respect to all electronic PHI; and implement and enforce related policies, procedures, and documentation standards. Among other things, such Safeguards shall prevent access, use or disclosures of PHI except as allowed by this Agreement or required by law, Administrative Safeguards shall include the development and use of such written policies and procedures as are required by the HIPAA Regulations. Technical Safeguards shall comply with the guidelines issued by the Secretary of the Department of Health and Human Services ("Secretary") from time to time pursuant to HITECH. (d) Business Associate specifically agrees to use its best efforts to secure all PI-il as necessary to avoid a "breach" as defined by HITECH and the HIPAA Regulations. In the event of an acquisition, access, use, or disclosure of PHI by Business Associate, or its subcontractors or agents, in a manner not permitted by this Agreement, Business Associate shall notify Covered Entity without unreasonable delay and in no event later than five (5) business days after the acquisition, access, use or disclosure is discovered. Business Associate shall promptly, and within five (5) business days after such notification, conduct a risk assessment as required under 45 CFR § 164.402, and send to Covered Entity its risk assessment determination and related analysis of whether such acquisition, access, use' or disclosure constitutes a "Breach" as defined by 45 CFR § 164,402. Business Associate shall provide all information relating to the matter to Covered Entity including but not limited to information requested by Covered Entity, to enable Covered Entity to review Business Associate's risk assessment and cooperate with Covered Entity during Covered Entity's investigation. Business Associate, upon Covered Entity's request and at Business Associate's sole cost and expense, shall make breach notifications necessary hereunder as directed by Covered Entity and in compliance with 45 CFR § 164.410. (e) Without limiting the generality of subsection (d), above, Business Associate further agrees to report to Covered Entity any attempted or successful unauthorized access, use, disclosure, modification or destruction of Protected Health Information or interference with system operations in any information system in which Protected Health Information subject to this Agreement is stored or otherwise maintained. (0 Business Associate agrees to prevent uses or disclosures of the Protected Health information other than those uses and disclosures permitted by this Agreement and to appropriately protect the confidentiality, integrity and availability of any electronic Protected Health Information that Business Associate creates, receives, maintains or transmits on behalf of Covered Entity. (g) Business Associate agrees to mitigate, to the extent practicable, any harmful effect that is known to Business Associate of a use or disclosure of Protected Health Information by Business Associate or its subcontractors or agents in violation of the requirements of this Agreement (h) Business Associate shall ensure that any agent, including a subcontractor, to whom it provides Protected Health Information received from, or created or received by Business Associate on behalf of Covered Entity, agrees to the same restrictions, conditions and requirements that apply through this Agreement to Business Associate with respect to such information, (i) Business Associate agrees to provide access within fifteen (15) days of a request by Covered Entity, and in the time and manner designated by Covered Entity, to Protected Health Information in a Designated Record Set, to Covered Entity or, as directed by Covered Entity, to an individual as necessary to satisfy Covered Entity's obligations under 45 CFR § 164.524. In the event that Business Associate receives a request for access to 2 Protected Health Information directly from an individual, Business Associate shall forward the individual's request to Covered Entity to fulfill. CD Business Associate agrees to make any amendment(s) to Protected Health Information in a Designated Record Set that Covered Entity directs or agrees to pursuant to 45 CFR § 164.526 within fifteen (15) days of the request of Covered Entity, and in the time and manner designated by Covered Entity. In the event that Business Associate receives a request for amendment to Protected Health Information directly from an individual, Business Associate shall forward the individual's request to Covered Entity to fulfill, (k) Business Associate agrees to make its internal practices, books, and records, including policies and procedures and Protected Health Information, relating to the use and disclosure of Protected Health Information received from, or created or received by Business Associate on behalf of, Covered Entity available to the Secretary, in the time and manner designated by the Secretary, for purposes of the Secretary determining compliance with the HIPAA Regulations. (I) Business Associate agrees to document disclosures of Protected Health Information and information related to such disclosures as would be required for Covered Entity to respond to a request by an individual for an accounting of disclosures of Protected Health Information in accordance with 45 CFR § 164.528. In the event that Business Associate receives a request for an accounting of disclosures of Protected Health Information directly from an individual, Business Associate shall forward the individual's request to Covered Entity to fulfill. (m) Business Associate agrees to provide to Covered Entity, in the time and manner designated by Covered Entity, information collected in accordance with subsection (I) above, to permit Covered Entity to satisfy its obligations and respond to a request by an individual for an accounting of disclosures of Protected Health Information in accordance with the HIPAA Regulations. (n) Business Associate further agrees to comply at all times with all other requirements of the HIPAA Regulations which may apply to Business Associate directly, or which may be necessary in order for Covered Entity to fully comply with the HIPAA Regulations. 3. Permitted Uses and Disclosures by Business Associate. (a) General Use and Disclosure Provisions. Except as otherwise limited in this Agreement, Business Associate may use or disclose Protected Health Information to perform functions, activities, or services for, or on behalf of, Covered Entity, as specified or contemplated under the applicable Services Agreement, to the extent that such use or disclosure would not violate the HIP AA Regulations if done by Covered Entity or the minimum necessary policies and procedures of Covered Entity. Except as permitted herein, Business Associate may not use or disclose PHI in a manner that would violate the Privacy Rule if done by Covered Entity. (b) Additional Use and Disclosure Provisions, Except as otherwise limited in this Agreement, Business Associate may use or disclose Protected Health Information for the proper management and administration of the Business Associate, as required by law, or to carry out the legal responsibilities of the Business Associate. (i) Except as otherwise limited by this Agreement, Business Associate may disclose Protected Health Information for the proper management and administration of the Business Associate, provided that such disclosures are required by law, or Business Associate obtains reasonable assurances from the person to whom the information is disclosed that it. will remain confidential and used or further disclosed only as required by law or for the purpose for which it was disclosed to the person, and the person notifies the Business Associate of any instances of which it is aware in which the confidentiality of the information has been breached. (ii) Except as otherwise limited by this Agreement, Business Associate may upon Covered Entity's request or as required under the Services Agreement, use Protected Health Information to provide Data Aggregation services to Covered Entity as permitted by 45 CFR § 164.504(e)(2)(i)(B). 3 (iii) Business Associate expressly acknowledges that Business Associate shall not use or disclose PHI for marketing or fundraising purposes without Covered Entity's express written permission. OBLIGATIONS OF COVERED ENTITY. 4.1 Covered Entity shall notify Business Associate of any limitation(s) of Covered Entity in its notice of privacy practices in accordance with 45 CFR 164.520, to the extent that such limitation may affect Business Associate's use or disclosure of PHI. 4.2 Covered Entity shall notify Business Associate of any changes in or revocation of permission by an Individual to use or disclose PHI, to the extent that such changes may affect Business Associate's use or disclosure of PHI. 4.3 Covered Entity shall use appropriate safeguards to maintain and ensure the confidentiality, privacy and security of PHI transmitted to Business Associate pursuant to this Agreement, the Contract, and the Privacy Rule, until such PHI is received by Business Associate, pursuant to any specifications set forth in any attachment to the Contract. 4.4 The Parties acknowledge that Covered Entity owns and controls its data. 4.5 Covered Entity shall provide Business Associate with a copy of its notice of privacy practices produced in accordance with 45 CFR Section 164.520, as well as any subsequent changes or limitation(s) to such notice, to the extent such changes or limitations may affect Business Associate's use or disclosure of PHI, Covered Entity shall provide Business Associate with any changes in or revocation of permission to use or disclose PHI, to the extent the changes or revocation may affect Business Associate's permitted or required uses or disclosures. To the extent that the changes or revocations may affect Business Associate's permitted use or disclosure of PHI, Covered Entity shall notify Business Associate of any restriction on the use or disclosure of PHI that Covered Entity has agreed to in accordance with 45 CFR Section 164.522. 5. Term and Termination. (a) Term. The Term of this Agreement shall be effective as of the Effective Date and shall remain in effect until such time as the Services Agreement is terminated or this Agreement is terminated for cause (as provided below). (b) Termination for Cause. Upon Covered Entity's knowledge of a material breach by Business Associate, Covered Entity shall: notify Business Associate of the breach and provide an opportunity for Business Associate to cure the breach or end the violation within ten (10) days, and terminate this Agreement and the underlying Services Agreement if Business Associate does not cure the breach or end the violation within the time specified by Covered Entity; (ii) immediately terminate this Agreement and the underlying Services Agreement if Business Associate has breached a material term of this Agreement and cure is not possible; or (iii) if neither termination nor cure are feasible, Covered Entity shall, to the extent required by the HIPAA Regulations, report the violation to the Secretary, (c) Effect of Termination. (i) Except as provided in subparagraph (ii) below, upon termination of this Agreement, for any reason, Business Associate shall return or destroy, at Covered Entity's option, all Protected Health Information received from Covered Entity, or created or received by Business Associate on behalf of Covered Entity, This provision shall also apply to Protected Health Information that is in the possession of subcontractors or agents of Business Associate. Business Associate shall ensure that its subcontractors and agents comply with this subsection (i). (ii) In the event that Business Associate determines that returning or destroying the Protected Health Information is infeasible, Business Associate shall provide to Covered Entity notification of the conditions that make return or destruction infeasible, Upon mutual agreement of the parties that return or destruction of 4 Protected Health Infommtion is infeasible, Business Associate shall extend the protections of this Agreement to such Protected Health Information and limit further uses and disclosures of such Protected Health Information to those purposes that make the return or destruction infeasible, for so long as Business Associate maintains such Protected Health Information or until Business Associate or Covered Entity determines that return or destruction is feasible. Business Associate shall ensure that the same provisions set forth in this subsection (ii) extend to any Protected Health Information in the possession of subcontractors or agents of Business Associate. (iii) At Covered Entity's request, Business Associate agrees to transmit, and to ensure that its subcontractors and agents transmit, the Protected Health Information to another business associate of Covered Entity at termination. 6. Miscellaneous. (a) Regulatory References. A reference in this Agreement to a section in the HIPAA Regulations means the section as in effect or as amended on or after the Effective Date. (b) Amendment. The parties agree to take such action as is necessary to amend this Agreement from time to time in order for Covered Entity to comply with the requirements of the HIPAA Regulations. No amendment shall be effective unless stated in writing and signed by the parties hereto. (c) Survival. The obligations of Business Associate under Sections 5 and 6 of this Agreement shall survive the termination of this Agreement. (d) Interpretation. Any ambiguity in this Agreement shall be resolved to permit Covered Entity to comply with the HIPAA Regulations. [e) No Third- Party Beneficiaries. Nothing in this Agreement shall be construed to confer any benefit or right on any person or entity not a party hereto. (0 Modification and Waiver. This Agreement shall not be amended or modified except in writing signed by both of the parties hereto. No waiver of any provision of this Agreement shall be valid unless permitted by applicable law, and then, only if in writing and signed by the party against whom such waiver is sought to be enforced. (g) Governing Law. For purposes of interpretation and enforcement of this Agreement, the laws of' the State of Michigan shall govern. (h) Entire Agreement. This Agreement constitutes the entire agreement between the parties hereto in connection with the subject matter hereof. This Agreement amends, supersedes and terminates in its entirety any and all other prior or contemporaneous agreements regarding the subject matter hereof, whether written or oral, between the parties hereto. TN WITNESS WHEREOF, the parties have caused this Agreement to be executed by their respective authorized representatives, effective as of the date first set forth above. Arcturus Healthcare, PLC By: Its: Business Associate: By: Its: 6 5 CLINICAL TRIAL SERVICES AGREEMENT This Clinical Trial Services Agreement ("Agreement") is made and entered into this day of July, 2017 by and between Arcturus Healthcare, PLC, Troy Internal Medicine Research Division located at 4550 Investment Drive, Suite 210, Troy, Michigan 48098 ("Arcturus") and the Oakland County Medical Examiner, located at 1200 North Telegraph Road, Building 28 East, Pontiac, Michigan 48341 ("OCME"). RECITALS A. Arcturus, Troy Internal Medicine Research Division will conduct an AVID Clinical Trial ("Trial"), which will require the completion of cranial autopsies on terminal hospice patients participating in the Trial ("Participants"); B. Arcturus desires to utilize OCME to conduct such cranial autopsies and related services in accordance with the terms set forth in this Agreement. NOW, THEREFORE, in consideration of the foregoing, and the mutual covenants of this Agreement, the Parties agree as follows: SCOPE OF AGREEMENT 1. Services. OCME, by and through its employed medical examiner ("Examiner"), agrees to complete a cranial autopsy, including brain photography with the possibility of collecting a fresh specimen for genetic testing, on each Participant in accordance with the AVID Technical Autopsy Manual. Arcturus will provide OCME a list of study subjects and contact OCME to retrieve a study subject. Examiner shall retrieve the Participant's body from Participant's place of death and transport the body to Examiner's office for the performance of Services.The majority of the Participants shall live within a twenty five (25) mile radius of the OCME' s office. The parties anticipate 5-10 Participants total. Examiner shall process the brain after removal with 10% formalin at room temperature for fourteen (14) to seventeen (17) days. Examiner shall ship the brain in accordance with the AVID Technical Autopsy Manual. The services defined in this Section 1 shall hereinafter be referred to as "Services." 2. Compensation. Arcturus shall compensate OCME for the Services provided in accordance with the compensation rates set forth in the schedule on Exhibit "A" attached hereto, and incorporated herein by reference. These compensation rates shall remain fixed until September 30, 2017. The parties expect such compensation rates will increase on October 1, 2017. 3. Term and Termination. 3.1 Term. This Agreement shall commence on July , 2017, and shall terminate upon completion of the Trial unless terminated by either Party in accordance with Section 3.2 of this Agreement. 3.2 Termination. This Agreement shall terminate for cause upon thirty (30) days advance written notice to the other Party. Either Party may terminate this Agreement without cause upon sixty (60) days written notice to the other Party. 4. Insurance. 4.1 Professional Liability Insurance. During the term of this Agreement, each Party shall procure and maintain professional liability insurance, or the equivalent thereof if either Party is self-insured, in such amounts and in such form and subject to such deductibles as each shall otherwise maintain for its operations and as shall reasonably insure each Party, their officers, directors, agents and employees against any claim or claims for damages arising directly or indirectly in connection with the provision of any services pursuant to this Agreement. 4.2 General Liability Insurance. During the term of this Agreement, each Party shall procure and maintain general liability insurance, or the equivalent thereof if either Party is self-insured, in such amounts, in such form and subject to such deductibles as each shall otherwise maintain for its operations and as shall reasonably insure each Party, its officers, agents, directors, and employees against any claim or claims for damages arising directly or indirectly in connection with the provision of any services pursuant to this Agreement. 5. Compliance with Laws, Rules, Regulations. Both Parties shall comply with federal, state and local laws, rules and regulations relating to the performance of its obligations pursuant to this Agreement. 6. Non-Liability of Other Party. Neither Party, by entering into and performing this Agreement shall become liable for any of the existing or future obligations, liabilities or debts of the other Party. 7. Notices. All notices, demands and requests authorized or implied through this Agreement shall be in writing and delivered in person or by mail to the following address or to such other address as either Party may hereafter specify through a Notice issued in accordance with the provisions of this paragraph: If to Arcturus: Arcturus Healthcare PLC Troy Internal Medicine Research Division 4550 Investment Drive Suite 210 Troy, MI 48098 If to OCME: Oakland County Medical Examiner 1200 North Telegraph Road Building 28 East Pontiac, MI 48341 8. Confidentiality and Non -Disclosure. OCME shall keep confidential and shall not disclose, or cause or permit to be disclosed, to any person or entity any information about the Trial or Participants or the contents of this Agreement, except in the event the disclosure of the information is required by law or court order. If OCME is required by law or court order to disclose any information about the Trial or its participants, OCME will give Arcturus reasonable advance notice of the disclosure. Notwithstanding the termination or expiration of this Agreement, OCME will continue to be bound by the obligations of this Section 8. 9. Michigan Laws. This Agreement shall be interpreted according to the laws of the State of Michigan. 10. Entire Understanding. This Agreement and its addendum constitute the entire understanding of the Parties with respect to the subject matter hereof and supersedes prior communications, written or oral. WHEREFORE, the Parties hereto have hereunto set their hands and seals as of the day and year first above written. Arcturus Healthcare PLC Troy Internal Medicine Research Division Chairman of the Board of Commissioners By: By: Its: Its: EXHIBIT "A" Compensation Service Description Contract Fee Cranial Autopsy (county resident) $500 Cranial Autopsy (non-county resident) $750 Pouches (body bags) $40 Charge per man if wait is over one hour, to be billed in 15 minute increments $9/hour Cost of a bio suit when approved by the ME0 as warranted by body removal circumstances $15 each Mileage charge, per loaded mile outside of a 25 mile radius of the Medical Examiner's office $2.00/Mile One Man Service, per trip. $99/Trip Two Man Service, per Trip. $149/Trip Storage Fee (if body is stored at Medical Examiner's office more than 4 days after cranial autopsy) $25/day BLOOMFIELD 56212-1 1849254v3 Confidential Disclosure Agreement Section 1 Parties; Defined Terms 1.1 This is an agreement between Avid Radiopharmaceuticals, Inc., a wholly-owned subsidiary of Eli Lilly and Company, with a place of business located at 3711 Market Street, Philadelphia, PA 19104 ("Avid") and Oakland County Medical Examiner's Office located at 1200 N Telegraph Rd #28, Pontiac, MI 48341 (the "Receiving Party"). 1.2 The purpose of this Agreement is for the Receiving Party and Avid to discuss arrangements under which Avid might furnish proprietary information to the Receiving Party concerning Avid's proprietary compounds, and clinical study "F-AV-1451-A16. Section 2 Term 2.1 This Agreement shall be effective upon final signature (the "Effective Date") and shall remain in effect for two years thereafter. Section 3 Definitions 3.1 Affiliate of a party means any entity that controls, is controlled by, or is under common control with that party. One entity is deemed to control the other if and only if it directly or indirectly: 3.1.1 owns more than fifty percent (50%) of the equity in the other; 3.1.2 controls more than fifty percent (50%) of the voting rights of the other; or 3.1.3 has been granted the power to cause the direction of the management and policies of the other by contract or otherwise. 3.2 Agreement means this Confidential Disclosure Agreement. 3.3 "Applicable Law" means any statute, law, treaty, rule, code, ordinance, regulation, permit, interpretation, certificate, judgment, decree, injunction, writ, order, subpoena, or like action of a governmental authority that applies, as the context requires to: (i) the Agreement; (ii) the performance of obligations or other activities related to the Agreement; and (iii) a party, a party's Affiliates (if any), a party's Subcontractors (if any), or to any of their Representatives. 3.4 Confidential Information means information that is designated as a party's Confidential Information elsewhere in this Agreement, subject to the conditions that follow. Except as otherwise provided by this Agreement, the status of information as a party's Confidential Information is not affeeted by the means by which the other party (the "acquiring party") acquires it. For example, Confidential Information may be acquired by written, oral, physical or electronic communication, either directly or through one or more intermediaries, or by visual observation. Similarly, acquisition or disclosure of Confidential Information may be either intentional or inadvertent without affecting its status. Notwithstanding anything to the contrary in this Agreement, Confidential Information does not include any information that: 3.4.1 was or becomes generally known to the public by means other than a breach by the acquiring party of a contractual, legal, or fiduciary duty of confidentiality owed to the disclosing party, its Affiliates, its Subcontractors (if applicable), or any of its or their Representatives; Page 1 of 1 3.4.2 is in the lawful possession of the acquiring party prior to acquisition as a result of this Agreement; 3.4.3 was or becomes available to the acquiring party on a nonconfidential basis from a third person that is not bound by any contractual, legal, or fiduciary duty of confidentiality to the disclosing party, to its Affiliates, or to the Representatives of the disclosing party or its Affiliates; or 3.4.4 is developed entirely by Representatives of the acquiring party who have no access to the disclosing party's Confidential Information. 3.5 Person means an individual or a partnership, corporation, association, limited liability company or other form of organization. 3.6 Purpose means the purpose of this Agreement set forth in 1.1_ 3.7 Representatives means a party's officers, directors, and employees, and agents. 3.8 "Subcontractor" means any Person that performs any of the obligations of Supplier under this Agreement, whether in privity to Supplier or in privity to another Subcontractor. Section 4 Avid's Confidential Information 4.1 Avid's Confidential Information includes all commercial, financial and proprietary information related to Avid's clinical protocol for study AV-1451-Al 6, including but not limited to clinical study and imaging procedures, protocols, results, pricing and fee information, and any other information related to the clinical study of Avid's proprietary drug AV-.1451, and to the drug AV-1451 itself. The Receiving Party will neither: 4.1.1 disclose or provide access to Avid's Confidential Information, directly or indirectly, except as authorized below or by Avid in writing; nor 4.1.2 use or produce Avid's Confidential Information for any purpose other than the Purpose of this Agreement. 4_2 The Receiving Party may disclose Avid's Confidential Information: 4.2.1 to its Representatives and to its Affiliates, Subcontractor; and their respective Representatives who need to know the information for the purpose of this Agreement and who have contractual obligations that prohibit any disclosure, use of or access to Avid's Confidential Information prohibited by this Agreement. The Receiving Party is responsible to Avid for any unauthorized disclosure, use of or access to Avid's Confidential Information by The Receiving Party's Representatives. 4.2.2 to the extent compelled by Applicable Law, The Receiving Party will give Avid reasonable advance notice of the disclosure. 4.2.3 in communications to its attorneys or accountants who have a professional obligation to maintain such information in confidence. The Receiving Party is responsible to Avid for disclosure or use by any such persons of Avid's Confidential Information, or access to such Confidential Information, not authorized by Avid. 4.3 The Receiving Party will promptly return to Avid or destroy all Records in its possession or control that contain Avid's Confidential Information when The Receiving Party no longer needs the Confidential Information to accomplish the Purpose. Page 2 of 2 4.4 The prohibitions on disclosure, use of or access to Avid's Confidential Information survive for five (5) years after expiration, termination, or cancellation of this Agreement or after The Receiving Party returns or destroys all Records of the relevant Confidential Information in its possession or control, whichever is later. Section 5 No Warranty/Ownership 5.1 The Confidential Information provided under this Agreement is provided by Avid "as is" without any warranty, whether express or implied, as to the accuracy or completeness, operability, use or fitness of such Confidential Information for a particular use. Avid will not be held liable for any damage arising pursuant to the usage of the Confidential Information provided under this agreement_ 5.2 The Receiving Party agrees that Avid is and shall remain the exclusive owner of its Confidential Information. No intellectual property rights, license or obligations other than those expressly recited are granted or to be implied from this Agreement_ Section 6 Injunctive Relief 6.1 6.2 Avid may seek an injunction restraining any breach or threatened breach without having to prove the inadequacy of monetary damages or irreparable harm and shall retains its right to seek any other relief or remedies available under applicable law. Section7 Integration and Amendment 7.1 This Agreement shall not be construed as an obligation to enter into any subsequent agreement. 7.2 This Agreement is the final, complete and exclusive expression of all the statements, promises and conditions within its scope and supersedes all prior written or oral agreements within its scope. In making this Agreement, neither party relies on any promise or statement made by the other party, other than those contained in the Agreement. 7.3 No amendment to this Agreement will be binding on either party unless it is in writing and signed by each party or executed in another manner expressly provided by this Agreement, Such an amendment does not require the consent or agreement of any third party, even if such third party is a beneficiary of this Agreement. Section 8 Export/Import Controls and Regulations 8.1 The Receiving Party agrees that Confidential Information may be subject to U.S. or other country export or import controls and regulations. The Receiving Party shall not export, re- export, or transfer Confidential Information, or any products developed with or utilizing Confidential Information, in violation of any applicable laws or regulations of the U.S. or other country where Confidential Information is obtained. Section 9 Contact Information 9.1 Notices to Avid: Page 3 of 3 Avid Radiopharmaceuticals, Inc. 3711 Market Street, 7 th Floor Philadelphia, PA 19104 Attention: Operations Department Telephone: (215) 298-0700 Facsimile: (413) 826-0416 9.2 Notices to The Receiving Party: The Receiving Party Contact Oakland County Medical Examiners Attn: Thomas Hardesty 1200 N. Telegraph Road Pontiac, MI 48341 Main Telephone: 248-858-1000 Email: hardestyt@oakgov,com Section 10 Choice of Law ICU This Agreement will be governed in all respects by the laws of Pennsylvania, excluding its rules on conflict of law. Page 4 of 4 AGREED AND ACCEPTED: AVID RADTOPHARMACEUTICALS, AGREED AND ACCEPTED: OAKLAND COUNTY MEDICAL EXAMINERS (ignb.tu-re of NuthorizVI Cifficial) Section 11Signatures This Agreement is legally binding when, but not until, each party has received from the other a counterpart of the Agreement signed by an authorized Representative. The parties' representatives may sign separate, identical counterparts of this document; taken together, they constitute one agreement. A signed counterpart may be delivered by any reasonable means, including facsimile or other Electronic transmission. (Sigglre of AUthorized Official) (Typed or Printed Name)Ed ward p. Borkowski Controller (Title of Authorized Official-required) NOV SO 2016 LJ DrAgovic, M.D. (Typed or Printed Name) Chief Medical Examiner (Title of Authorized Official-required) November 18, 2016 (Date) (Date) Page 5 of 5 Resolution #17244 August 23, 2017 The Vice Chairperson referred the resolution to the Finance Committee. There were no objections.