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Item 4F - MemoItem 4F CITY OF SOUTHLAKE MEMORANDUM August 6, 2024 To: Mayor and City Council From: Ashleigh Casey, Chief of Police Subject: Approve Contract with Grail, Inc. for Police and Fire FY 2024 Cancer Screenings Action Requested: Approve a contract with GRAIL, Inc. for cancer screenings for the Police and Fire Department in an amount not to exceed $62,000. Background Information: The purpose of this item is to seek Council consideration approving a contract with GRAIL, Inc. for Police and Fire Department cancer screenings in an amount not to exceed $62,000. Firefighting is a hazardous profession that exposes firefighters to a variety of health risks, including physical injuries, burns, smoke inhalation, and exposure to hazardous materials. The National Fire Protection Association (NFPA) establishes standards that outline the medical evaluations that firefighters should undergo to determine and maintain their fitness for duty. Much like firefighters, police officers are often exposed to the same types of risks during the course of their duties. The addition of cancer screenings to annual police and fire physicals helps mitigate these risks through early detection when treatment is most successful. Upon approval, the screenings will be funded out of the current FY 2024 approved Police and Fire General Fund budgets, and they will be completed by September 30, 2024. Strategic Link: C1 - Achieve the highest standards of safety & security. Legal Review: The contract was reviewed by the City Attorney. Supporting Documents: FY 2024 Grail, LLC contract Staff Recommendation: Staff recommends approval of the FY 2024 Grail, Inc. contract as proposed. GRAIL, INC. TEST PURCHASE AGREEMENT This Test Purchase Agreement (the "Agreement") is made effective as of the date of the last signature below (the "Effective Date") by and between GRAIL, Inc., a Delaware corporation with a principal place of business at 1525 O'Brien Drive, Menlo Park, CA 94025 ("GRAIL") and the City of Southlake, Texas, having a principal place of business at 600 State Street, Southlake, TX 76092 ("City"). City and GRAIL may each individually be referred to herein as a "FgM" or collectively as the "Parties." WHEREAS, City wishes to purchase GRAIL's Galleri®, a multi -cancer early detection test (the "Test") and such other laboratory tests from GRAIL from time to time (collectively, the "Laboratory Test(s)"), as more fully set forth in each applicable Test purchase specific addendum to be attached to this Agreement and incorporated herein by reference (the "Purchase Addendum"); NOW, THEREFORE, in consideration of the premises and the mutual promises set forth in this Agreement, and other good and valuable consideration, the exchange, receipt and sufficiency of which are acknowledged, the Parties agree as follows: 1.0 Test Purchases 1.1 Purchase Addenda. Each Purchase Addendum will include (a) a description of the Laboratory Test(s); (b) applicable fees, and (c) any other responsibilities mutually agreed by the Parties. To the extent any terms set forth in a Purchase Addendum conflict with the terms set forth in this Agreement, the terms of this Agreement will control unless otherwise expressly agreed by the Parties in such Purchase Addendum that the conflicting terms in such Purchase Addendum will control. 1.2 Invoices. GRAIL will invoice City and/or any applicable third party for the Laboratory Tests in each case as described in the Purchase Addendum. Invoicing will follow the delivery of the Laboratory Test results report. City will pay each invoice within thirty (30) days of the invoice date. In the event the City fails to make payments due, GRAIL reserves the right to suspend providing Laboratory Tests and collection materials. 1.3 Pavments. All payments of amounts owing to GRAIL will be made at the following account or address or such other account or address designated by GRAIL in writing: For electronic payment: Beneficiary: Beneficiary Address: Bank Name: Bank Address: Routing & Transit Number: SWIFT Code: Account Number: For payment by check: GRAIL, Inc. Dept LA 25195 Pasadena, CA 91185-5195 GRAIL, Inc. 1525 O'Brien Dr. Menlo Park, CA 94025, USA Silicon Valley Bank 3003 Tasman Drive Santa Clara, CA 95054, USA 121140399 SVBKUS6S 3303126108 2.0 SDecimens and Personal Data 2.1 Protections. GRAIL is a Covered Entity healthcare provider under the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations at 45 C.F.R. Part 160 and Part 164 (Subparts A — E) (collectively, "HIPAA"), and therefore any personal data about a participant in City's offering of the Laboratory Test that GRAIL receives directly from either (a) such participant, or (b) a healthcare professional who orders the Laboratory Test for such participant, ("Participant Personal Data"), is governed by HIPAA and is subject to GRAIL's administrative, technical, and physical safeguards and applicable policies for protecting the privacy and security of Protected Health Information (defined as specified in the HIPAA Privacy Rule 45 CFR 160.103). The Parties will maintain records and data related to its obligations under this Agreement in accordance with applicable laws. 2.2 Collection and Rights. For Laboratory Tests collected by GRAIL's third -party phlebotomy provider, GRAIL will ensure transfer of blood specimens from patient(s) ("SDecimens") by such third -party provider to GRAIL. As between the Parties, GRAIL will own all rights, title and interest in and to Specimens and will have sole right to use and analyze Specimens and any related Participant Personal Data consistent with the permissions granted by relevant participants in connection with the Test and applicable laws. City will have no access to Specimens and such Participant Personal Data. 2.3 Inability to Process. GRAIL may not be able to process Specimens or to provide Laboratory Test results reports in certain instances, including but not limited to: (a) Specimens lost or damaged prior to delivery at GRAIL laboratories; (b) contaminated Specimens; (c) incomplete or inaccurate information on the Laboratory Test requisition form; (d) the relevant patient canceling the Laboratory Test; (e) the ordering healthcare professional canceling the Laboratory Test; and (f) shipping delays. SDecimens collected from patients who are twentv-one (21) vears old or vounger or who are pregnant will not be Drocessed. 3.0 Confidentiality 3.1 Confidential Information. The Parties acknowledge that a Party (the "Recipient") may have access to confidential or proprietary information ("Confidential Information") of the other Party (the "Discloser") in connection with this Agreement. In order to be protected as Confidential Information, information must be marked or confirmed in writing as such or it must be information reasonably expected to be treated in a confidential manner under the circumstances of disclosure or by the nature of the information itself. During the Term of this Agreement and for a period of five (5) years thereafter, the Recipient will hold the Discloser's Confidential Information in confidence using at least the degree of care that is used by the Recipient with respect to its own Confidential Information, but no less than reasonable care. Unless disclosure is required by applicable law, as described in Section 3.3 below, the Recipient will disclose the Confidential Information of the Discloser solely on a need -to -know basis to its employees, contractors, officers, directors, and representatives who are subject to confidentiality obligations at least as protective of the Confidential Information as the terms of this Agreement. The Recipient will not use the Discloser's Confidential Information for any purpose other than exercising its rights and fulfilling its obligations under this Agreement. The Discloser retains all right, title and interest in and to its Confidential Information. This Agreement does not and shall not be construed to give the Recipient any right or license, by implication or otherwise, to any Confidential Information of the Discloser or any intellectual property or other rights owned by or licensed to the Discloser, except the right to use Confidential Information solely for performance of the Services. 3.2 ExceDtions. Notwithstanding any provision contained in this Agreement to the contrary, the Parties' confidentiality and non-use obligations shall not apply to: (a) information that, at the time of disclosure to the Recipient, is in the public domain through no breach of this Agreement or breach of another obligation of confidentiality owed to the Discloser by the Recipient, (b) information that, after disclosure hereunder, becomes part of the public domain by publication or otherwise, except by breach of this Agreement or breach of another obligation of confidentiality owed to the Discloser by the Recipient; (c) information that was in the Recipient's possession at the time of disclosure by the Discloser unless subject to an obligation of confidentiality or restricted use owed to the Discloser; (d) information that is independently developed by or for the Recipient without use of or reliance on Confidential Information of the Discloser, or (e) information that the Recipient receives from a third party where such third party was under no obligation of confidentiality to the Discloser with respect to such information. 3.3 Required Disclosures. The Recipient may disclose Confidential Information of the Discloser as required by court order, operation of law, government regulation, or as required under Texas Government Code Chapter 552; provided that, the Recipient promptly notifies the Discloser of the requirement prior to disclosure, uses diligent and reasonable efforts to limit the scope of such disclosure or obtain confidential treatment of the Confidential Information if available and allows the Discloser to participate in the process undertaken to protect the confidentiality of the Discloser's Confidential Information, as permitted by law. 4.0 Indemnification and Limitation of Liabilitv 4.1 Indemnification. GRAIL hereby agrees to defend, hold harmless and indemnify the City and its officers, directors, employees, agents, and representatives from and against any and all liabilities, expenses, damages and/or losses (including without limitation reasonable legal expenses and attorneys' fees) resulting from any third -party claim to the extent arising out of (a) the material breach by GRAIL or its officers, directors, employees, agents, or representatives of its obligations under this Agreement, (b) the gross negligence or willful misconduct of GRAIL or its officers, directors, employees, agents or representatives in the performance of its obligations under this Agreement, or (c) any failure by GRAIL to comply with any applicable federal, state, or local laws, regulations, or codes in the performance of its obligation under this Agreement. 4.2 Indemnification Procedure. To be eligible to be indemnified hereunder, the City will provide GRAIL with prompt notice of the third -party claim giving rise to the indemnification obligation pursuant to this Article 4 and the right to control the defense (with the reasonable cooperation of the indemnified Party) and settlement of any such claim; provided, however, that GRAIL will not enter into any settlement that admits fault, wrongdoing or damages without the City's written consent. The City will have the right to participate, at its own expense and with counsel of its choice, in the defense of any claim or suit that has been assumed by GRAIL. 4.3 Limitation of Liabilitv. IN NO EVENT WILL GRAIL BE RESPONSIBLE FOR ANY PUNITIVE DAMAGES OR ANY CONSEQUENTIAL, INCIDENTAL, INDIRECT, OR SPECIAL DAMAGES (INCLUDING LOST PROFITS OR REVENUE) OF CITY OR OF ANY THIRD PARTY. 5.0 Term and Termination 5.1 Term. This Agreement will commence on the Effective Date and continue in effect for an initial one (1) year period ("Initial Term") and will automatically extend for two (2) additional one (1) year periods (each, a "Renewal Term") unless earlier terminated in accordance with Section 5.2. 5.2 Termination. This Agreement may be immediately terminated by either Party upon written notice, if the other Parry is in material breach of this Agreement and fails to cure that breach within thirty (30) days after receiving written notice from the non -breaching Party. This Agreement may be terminated by either Party, without cause, upon thirty (30) days' prior written notice to the other Party. 5.3 Effect of Termination. Upon termination or expiration of this Agreement for any reason, City will make payment to GRAIL for any Laboratory Tests results reports delivered, including those provided after the termination or expiration date for Laboratory Tests ordered prior to such date (other than those for which GRAIL has agreed in the Purchase Addendum to invoice any third party). In addition, City will return any Collection Materials it possesses as of the expiration or termination date back to GRAIL. 5.4 Survival. Expiration or termination of this Agreement for any reason will not affect either Party's rights or obligations which, at the time of such expiration or termination, have already accrued to such Party. In addition, the obligations of the Parties contained in Articles 3, 4, and 6 and Sections 2.2, 5.3, and 5.4 hereof will survive expiration or termination of this Agreement. 6.0 Miscellaneous 6.1 Force Maieure. In the event either Parry will be delayed or hindered in or prevented from the performance of any act required hereunder by reasons of strike, lockouts, labor troubles, pandemic, restrictive government or judicial orders or decrees, riots, insurrection, war, Acts of God, inclement weather or other similar reason or cause beyond such Parry's reasonable control, then performance of such act will be excused for the period of such delay, and the affected Party will receive time to perform the act equal to the period of delay. Notice of the start and stop of any such force majeure will be promptly provided to the other Party, and the affected Party will use commercially reasonable efforts to end the delay and resume performance under this Agreement as soon as reasonably practicable. 6.2 Notices. Every notice or other communication required or permitted under this Agreement or by applicable laws will be in writing and will be deemed to have been delivered and received (a) when personally delivered, (b) on the seventh (7d') business day after which sent by registered or certified mail, (c) by email with confirmation by the recipient confirming such email has been received and reviewed, or (d) on the third (3rd) business day after the business day on which deposited with a regulated public carrier (e.g., FedEx) for overnight delivery (receipt verified), addressed to the Party as specified in this Section. For GRAIL GRAIL, Inc. 1525 O'Brien Drive Menlo Park, CA 94025 Attn: Legal Email: legalnotice94025@grailbio.com For City City of Southlake 600 State Street Southlake, TX 76092 Attn: Chris Brown Email: cbrown@ci.southlake.tx.us 6.3 Publicity: Use of Name. Following execution of this Agreement, City and GRAIL will discuss strategic public relations activities to support publicly announcing the execution of this Agreement, which may include a joint press release. The content and timing of any press release will be mutually agreed upon by the Parties and approved by each Party's corporate communications team. Each 4 Party's corporate name, logo, trademark, or product name(s) may be used only with such Party's prior written consent from an authorized official for such use on each occurrence. 6.4 Compliance with Laws. Each Party will comply with all applicable state and federal laws and regulations in the performance of this Agreement. 6.5 Governing Law; Venue. This Agreement shall be governed by the laws of the State of Texas as to all matters, including but not limited to matters of validity, construction, effect and performance, without regard to conflict of law principles. All actions regarding this Agreement shall be in a court of competent subject matter jurisdiction in Tarrant County, Texas 6.6 Severability. Waiver. If any one or more provisions of this Agreement will be found to be illegal or unenforceable in any respect, the validity, legality and enforceability of the remaining provisions will not in any way be affected or impaired thereby, provided the surviving agreement materially comports with the Parties' original intent. Waiver or forbearance by either Party or the failure by either Party to claim a breach of any provision of this Agreement or exercise any right or remedy provided by this Agreement or applicable law, will not be deemed to constitute a waiver with respect to any subsequent breach of any provision hereof. 6.7 Entire Agreement; Amendments. This Agreement, including all Purchase Addenda, represents the complete and entire understanding between the Parties regarding the subject matter hereof and supersedes all prior negotiations, representations or agreements, either written or oral, regarding this subject matter. No changes or modifications of this Agreement or any Purchase Addendum will be deemed effective unless in writing and executed by the Parties hereto. 6.8 Independent Contractor. In performing the services under this Agreement, GRAIL is acting as an independent contractor. No term or provision hereof shall be construed as making GRAIL the agent, servant, or employee of the City or as creating a partnership or joint venture relationship between GRAIL and the City. No employee, agent, servant, or subconsultant of GRAIL shall be deemed to be an employee of the City. 6.9 Assignment. Any purported assignment or delegation by a Party of this Agreement in whole or in part without the prior written consent of the other Party shall be void; provided, however, that either Party may assign or transfer its rights and obligations under this Agreement, without such consent, to an affiliate or a purchaser of all or substantially all of the stock or assets of a Party or to an entity into which such Party is merged. This Agreement shall be binding upon the Parties, their successors and their permitted assigns. IN WITNESS WHEREOF the Parties hereto have executed this Agreement as of the Effective Date. GRAIL, INC. CITY OF SOUTHLAKE By: By: Name: Name: Title: Title: Date: Date: PURCHASE ADDENDUM NO. 1 This Purchase Addendum No. I ("Purchase Addendum No. I") is intended to supplement and be read together with the Test Purchase Agreement by and between City of Southlake ("Ci1y") and GRAIL, Inc. ("GRAIL") effective as of the date of the last signature below (the "Agreement"). This Purchase Addendum No. 1 is incorporated herein to the Agreement by this reference. All capitalized terms not defined in this Purchase Addendum No. 1 will have the meanings given to them in the Agreement. This Purchase Addendum No. 1 will remain in effect until expiration of the Agreement, unless the Agreement is earlier terminated as provided therein. 1.0 The Offering 1.1 Scope. The Test will be made available as an offering (the "Offering") to U.S.- based firefighters, police officers, and EMS workers (active, volunteer, and retired only) and their spouses ("Eligible Participants" or "First Responders"). 1.2 Implementation. Eligible Participants who request a Test (whether or not a Test is authorized, a "User") will have their requests reviewed by third party healthcare professionals under the direction and control of GRAIL's telemedicine or, as applicable, onsite provider (each a "Healthcare Professional"). The Healthcare Professional will, for Users for whom a Test request is authorized, be responsible for ordering the Test via a Test requisition form. GRAIL will also arrange for a phlebotomy provider who can assist with Specimen collection. 1.3 Determination of Use Criteria. GRAIL intends the Test for use in adults with an elevated risk for cancer, such as those aged 50 or older. City is solely responsible for determining the age, risk factors, and any other criteria required for those whom the Test may be ordered by a Healthcare Professional. City acknowledges that GRAIL has not yet examined the performance of the Test in all elevated cancer risk populations included in the criteria and performance of the Test could vary in those populations, which may result in a decreased cancer signal detected rate in those aged under 50. City acknowledges the cancer signal detected rate for those under age 50, regardless of other factors contributing to an elevated risk for cancer, may be lower than those aged 50+. 1.4 Test Processing. GRAIL will process the Specimen collected for the Test and provide a Test results report for each Test ordered to the Healthcare Professional who issued the Test requisition form to GRAIL, unless the Test is canceled, or the Specimen is unable to be processed. In the event that GRAIL is unable to generate a Test results report for a User, GRAIL will notify the Healthcare Professional in a timely manner. Test results shall be provided to Healthcare Professionals and/or Users in accordance with GRAIL's standard operating procedures in a timely manner. 1.5 Collection Materials. GRAIL or its designee will deliver or otherwise make available the kits necessary for collection of the Specimens for Users for whom a Test has been authorized. If GRAIL determines, in its sole discretion, that City has breached the terms of the Agreement or this Purchase Addendum No. 1, GRAIL reserves the right, in addition to the other remedies available hereunder, to cease the provisioning of kits. 1.6 Access to the Offering. City and GRAIL may agree to utilize the eligibility file method and/or Galleri Key method (each as further described below) to provide Eligible Participants access to the Offering. a) Eligibility File and Data. If the Parties agree to use the eligibility file method, City will provide GRAIL with eligibility files, in accordance with GRAIL's specifications for format and transmission method and such other requirements provided by GRAIL in writing, necessary for GRAIL to verify whether an Eligible Participant (based on the eligibility criteria determined by City) may participate in the Offering, and GRAIL, itself or through a third -party, will process the eligibility files to perform such verification and GRAIL may utilize such eligibility file information for other activities in support of the Offering, including any business review for City, other City requests for reporting or analytics, and any communications activities described herein or in the communications plan. If City requires use of a City -specific eligibility file format or transmission method, additional approvals and fees may apply. City agrees to timely provide GRAIL with accurate eligibility files prior to the agreed upon launch of the Offering and at the frequency mutually agreed upon by the Parties. The Parties acknowledge and agree that any eligibility file data and other personal data provided to GRAIL by City is Confidential Information of City. GRAIL does not perform eligibility verification at the time of invoicing and City agrees that City remains responsible for payment with respect to any Test results report delivered regardless of whether the applicable patient remains an Eligible Participant at the time of invoicing. (i) City represents and warrants that it has obtained all necessary rights, authorizations, and consents from its Eligible Participants in accordance with applicable laws in order to collect any and all data and information in the eligibility files, to transfer such data and information to GRAIL, and for GRAIL to use such data and information for the Offering. b) Galleri Kev (Eligibility File Replacement). If the Parties agree to use the Galleri Key method, GRAIL will generate and provide to City unique alphanumeric codes necessary for Eligible Participants to access GRAIL's contracted independent telemedicine healthcare provider to have a Test request reviewed by a Healthcare Professional ("EFR Galleri Kev"). (i) City acknowledges and agrees that GRAIL will not verify whether an individual using an EFR Galleri Key is an Eligible Participant, and further, that neither the Healthcare Professional nor GRAIL's contracted telemedicine provider will review Test orders to confirm eligibility other than the Healthcare Professional utilizing his/her own medical and clinical judgment in determining whether to order the Test (for example, no review will be performed to determine whether an individual seeking the Test is enrolled in a specific health plan even if that is a requirement for participation in the Offering). City agrees that City remains responsible for payment with respect to any Test results report delivered as a result of use of an EFR Galleri Key, regardless of whether, for example, the applicable patient is an Eligible Participant at the time of invoicing. (ii) Each EFR Galleri Key becomes active for use upon delivery to the City or, as applicable, delivery by GRAIL to Eligible Participants. All unused EFR Galleri Keys expire at midnight 11:59 PT on the earlier of: (a) the date or the number of days after the delivery of the EFR Galleri Key that the Parties have agreed in writing for that specific distribution of EFR Galleri Keys); or (b) the termination of the Agreement. City will cease distribution of the EFR Galleri Key (if City is distributing) and agrees that GRAIL may cease distribution (if GRAIL is distributing) and deactivate all EFR Galleri Keys in the event the Agreement is terminated for any reason or if City violates any terms of the Agreement. If City is distributing EFR Galleri Keys Company will promptly disclose any eligibility requirements and will be responsible for ensuring that EFR Galleri Keys are distributed only to persons consistent with City determined eligibility requirements. City will include the expiration date of the EFR Galleri Key on any instrument used to distribute the EFR Galleri Key (e.g., email, cards, etc.). City will not export any EFR Galleri Key for use outside the United States, and acknowledges that Test orders from outside the United States will be refused. 1.7 If City desires to make changes to eligibility criteria for the Offering, including to enable any individual who is not an Eligible Participant to access the Offering, only City's designated principal contact, Chris Brown, may authorize such changes to eligibility criteria and, in such cases, such authorization will be made in writing and City is solely responsible for any such changes. 2.0 Pavments. Schedule 2.1 Pavment: GRAIL will process the Test at a charge of $649.00 per Test for Eligible Participants. 2.2 Pavment Schedule: GRAIL will invoice City on a calendar month basis for all Test results reports delivered in the preceding calendar month. GRAIL will invoice Users directly. User invoices are due within thirty (30) days of User's receipt of invoice. For avoidance of doubt, to the extent any Tests were ordered for a User during the term of this Purchase Addendum No. 1, City will pay such amount for each Test even if the Test results report is delivered after the termination of this Purchase Addendum No. 1. City will be solely responsible for compensating GRAIL for the Test, and GRAIL will not be required to seek any amounts from any Healthcare Professional or patient. GRAIL and City concur with the above and City authorizes GRAIL, and GRAIL agrees, to begin this Purchase Addendum No. 1, each by signing in the space provided below. GRAIL, Inc. CITY OF SOUTHLAKE By: By: Name: Name: Title: Title: Date: Date: