IMPLEMENTATION GUIDE
Last Updated: May 20, 2026
This Implementation Guide (“Guide”) provides an overview of implementation activities or features that you, the Customer, and GRAIL, Inc. (“GRAIL”) may mutually agree to include in the Galleri® test offering (“Offering”). If you decide to include any of these additional activities or features in the Offering, you will comply with the terms associated with such activities or features. This Implementation Guide is hereby incorporated by reference into the Galleri® Testing Agreement between you and GRAIL.
1. Communications Plan. GRAIL and Customer may jointly develop a communications plan to raise awareness of the Offering with Eligible Participants and/or Eligible Participants who have requested the Test (“Test Requesters”), and any such plan will be mutually agreed between the Parties (“Communications Plan”). The Communications Plan may include provision of a landing page where Eligible Participants can view information regarding the Offering and request a Test via registration with GRAIL’s patient portal.
2. Direct Communications. GRAIL may, with the prior written approval of Customer and subject to Section 4 below, contact Eligible Participants and/or Test Requesters directly to raise awareness of the Offering, including to carry out communications pursuant to the Communications Plan through postal and/or electronic mail (collectively, “Direct Communications”).
3. Access to the Offering. Eligible Participants may access the Offering via one or more of the standard methods described below. Customer and GRAIL may agree to a different method or modifications to the standard methods, which may incur additional costs.
- (i) Eligibility File. If Customer and GRAIL agree to use the eligibility file method, Customer will provide GRAIL with eligibility files, in accordance with GRAIL’s specifications, to verify whether an Eligible Participant may participate in the Offering. Customer 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.
- (ii) Galleri Key (Eligibility File Replacement). If the Parties agree to use the Galleri Key method, GRAIL will generate and provide to Customer 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 Key“).
- (iii) Acknowledgement. Customer acknowledges and agrees that GRAIL cannot verify whether an individual using an EFR Galleri Key is actually an Eligible Participant under Customer’s criteria for Eligible Participants (“Offering Eligibility”). 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 Customer-determined criterion for participation in the Offering. Customer agrees that Customer 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.
- (iv) Activation and Responsibility. Each EFR Galleri Key will become active for use upon and expire on dates mutually agreed to by Customer and GRAIL. All unused EFR Galleri Keys will expire on such mutually agreed upon expiration date, with such date being no later than the termination of the Agreement. Customer will cease distribution of the EFR Galleri Key (if Customer 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 Customer violates any terms of the Agreement and fails to cure such violation within fifteen (15) days of written notice from GRAIL; provided, however, that no cure period will apply to violations that, in GRAIL’s reasonable determination, cannot be cured. If Customer is distributing EFR Galleri Keys, Customer will promptly disclose any eligibility requirements and will be responsible for ensuring that EFR Galleri Keys are distributed only to persons consistent with Customer-determined eligibility requirements. Customer 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.). Customer 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.
- (v) Roster List. If the Parties agree to use the Roster List method, Customer will either provide GRAIL with the list of Eligible Participants or Customer will instruct only the Eligible Participants to take part in the Offering (e.g., attending an onsite testing event for the Offering). In the former, GRAIL will use such list to verify such person’s Offering Eligibility. In the latter, the GRAIL will not be responsible for any persons who self-attest to being an Eligible Participant and who access the Offering, including taking the Test. Customer will be responsible for paying GRAIL for any Tests resulting from such persons.
- (vi) Insurance Workflow. If the Parties agree to use the Insurance Workflow method, GRAIL will assess Offering Eligibility when a Test Requester submits an order via the GRAIL patient portal, wherein the Test Requester will submit insurance details. It is the Test Requester’s responsibility to ensure he or she inputs the correct information into the patient portal in order for GRAIL to verify whether he or she is an Eligible Participant or not. Customer acknowledges that GRAIL’s eligibility determination under this method is based solely on the information submitted by the Eligible Participant and that GRAIL will not be liable for any inaccuracy in such information.
4. Representations and Warranties. Customer represents and warrants that prior to the transfer of any Eligible Participants and/or Test Requesters’ personal information and related data (including such information in the eligibility files and marketing lists), Customer has or will obtain from its Eligible Participants and/or Test Requesters any and all necessary rights, consents, and authorizations required by applicable law in order for Customer to collect any and all such data and information, to transfer such data and information to GRAIL, and for GRAIL to use such data and information for purposes described herein in support of the Offering, including, (i) if Direct Communications are approved by Customer in accordance with Section 2 above, for the purpose of Direct Communications, and (ii) if requested or approved by Customer any other such requested or approved activities in support of the Offering, including any business review for Customer, or other Customer requests for reporting or analytics. GRAIL will handle all personal information received from Customer in accordance with the Data Privacy & Information Security Addendum incorporated into the Galleri Agreement, including applicable security, data retention, and breach notification obligations set forth therein. GRAIL will use personal information received from Customer only for the purposes described in this Guide, the DPA, and as otherwise approved by Customer in writing.
5. Engagement Reporting. Subject to applicable law, GRAIL may provide de-identified and aggregated data only for engagement reporting on the Offering to Customer. Customer acknowledges that surveys about the Test experience may be utilized to measure employee satisfaction with the Offering for Engagement Reporting purposes. Customer will not re-identify, attempt to re-identify, or allow any third-party to re-identify any individual(s) whose personally identifiable information is contained within any dataset provided hereunder.