Contract analysis

I. Purpose and Scope of Memorandum This memorandum establishes a uniform, defensible protocol for the privilege review of documents collected from GenomeDx's eleven (11) identified custodians in connection with GenomeDx's document production obligations to defendant and counterclaimant Helios Precision Diagnostics, Inc. ("Helios") in the above-captioned patent infringement action. The protocol set forth herein is des

II. Applicable Legal Standards A. Attorney-Client Privilege The attorney-client privilege protects confidential communications between a client and its attorney (or their respective agents) made for the purpose of obtaining or providing legal advice. Under Ninth Circuit law, the party asserting the privilege bears the burden of establishing each element: (1) that a communication was made between the client (or the cl

III. Custodian Identification and Document Sources A. List of GenomeDx Custodians Eleven (11) custodians have been identified for document collection in this matter. The following is the current custodian list, together with each custodian's role and relevance to the privilege review:

1. Dr. Rajan Mehta — Chief Technology Officer and named inventor on all three patents-in-suit (the '271 Patent, the '893 Patent, and the '647 Patent). Dr. Mehta is a central figure in the technical development of GenomeDx's Decipher® genomic test and is likely to have extensive communications with in-house and outside counsel regarding patent prosecution, claim strategy, and litigation. His communications with C&H an

2. Dr. Kevin Ostrowski — Vice President, intellectual Property; named inventor on the '647 Patent; holds both a PhD (molecular biology) and a JD. As discussed in Section II.A above and Section VIII.A below, Dr. Ostrowski is a "dual-hat" custodian whose communications require heightened scrutiny to distinguish between his legal and scientific/technical roles.

3. Dr. Miriam Langford — Chief Executive Officer. Dr. Langford's communications with counsel regarding litigation strategy, business implications of the litigation, and board-level decisions are likely to include privileged content. However, communications in which she is directing business operations, managing investor relations, or overseeing commercial strategy are not privileged merely because they reference the

4. Victoria Sung — General Counsel. As GenomeDx's chief legal officer, Ms. Sung's communications are presumptively more likely to involve legal advice, but the same business/legal distinction applies. Ms. Sung's communications with C&H are privileged. Her internal communications with GenomeDx employees are privileged to the extent they reflect legal advice. Her communications with Pinnacle and Ridgeline representativ

5. Thomas Brennan — Chief Financial Officer. Mr. Brennan's documents are principally relevant to damages issues. Communications with counsel regarding damages calculations, licensing revenue, and financial aspects of the litigation may be privileged. Financial records and reports prepared in the ordinary course of business are not privileged.

6. Dr. Priya Shah — Principal Scientist and named inventor on the '647 Patent; current GenomeDx employee. Standard custodian treatment applies. Communications with in-house or outside counsel regarding patent prosecution or the litigation are potentially privileged.

7. Brian Calloway — Director of Regulatory Affairs. Mr. Calloway's documents may include communications regarding the FDA De Novo application and MAAA code application. See Section VIII.E for treatment of regulatory submissions.

8. Dr. Yuki Tanaka — Senior Scientist, Research & Development. Involved in Decipher® test development. Standard custodian treatment.

9. Marcus Henley — Vice President, Commercial Operations. Communications regarding competitive positioning vis-à-vis Helios's ProstaSignal™ product. Primarily business documents; privilege likely to arise only in communications with counsel.

10. Jennifer Kowalski — Director of Business Development. Involved in licensing discussions, including the Veridian Molecular Labs license. See Section VIII.D for treatment of licensing-related documents.

11. Sarah Chen — Senior Product Manager. Documents related to Decipher® product specifications and market analysis. Standard custodian treatment. Note: The identities and roles of custodians 6 through 11 as listed above are preliminary. The names and titles of certain custodians remain subject to confirmation with GenomeDx. Peter Vassiliev should coordinate with Victoria Sung to finalize the custodian list and provid

IV. Privilege Review Workflow The privilege review will be conducted in four sequential phases, each building upon the preceding phase to ensure comprehensive and defensible identification of privileged documents. The workflow is designed to leverage the efficiency of technology-assisted review while maintaining the rigor of human attorney review for all privilege determinations. A. Phase 1: Automated Privilege Scree

1. Attorney Involvement: Is the communication to, from, or copying an attorney acting in a legal capacity? If an attorney is a party to the communication, proceed to the next criterion. If no attorney is involved, the document is generally not privileged (but may qualify as work product if prepared in anticipation of litigation — proceed to criterion 4).

2. Purpose — Legal Advice: Was the communication made for the purpose of seeking or providing legal advice, as distinguished from business advice, technical input, or operational directives? If the communication seeks or provides legal advice, proceed to the next criterion. If the communication is purely business in nature, the document is not privileged even if an attorney is a party to the communication.

3. Confidentiality: Was the communication maintained in confidence? Was it shared with any non-privileged third parties (e.g., non-attorney employees who had no need to know, external parties, investors)? If the communication was shared with a non-privileged third party, the privilege may have been waived. Evaluate whether a common-interest or other exception applies. If the communication was maintained in confidence

4. Work Product: If the document does not qualify as an attorney-client privileged communication, was the document prepared in anticipation of litigation? If so, does the document reflect attorney mental impressions, conclusions, opinions, or legal theories (opinion work product), or does it consist of factual compilations or investigative summaries (fact work product)? Code the work-product designation accordingly.

1. Dr. Kevin Ostrowski Dual-Hat Communications: Any communication involving Dr. Ostrowski where the reviewer is uncertain whether Dr. Ostrowski was acting in a legal capacity or in his capacity as a scientist, inventor, or business executive. This includes, without limitation, communications about patent claim drafting or prosecution strategy (likely privileged), communications about experimental design, assay develo

2. Pinnacle Biosciences Capital Communications: Any document shared with, or copied to, Jonathan Hargrove or other Pinnacle Biosciences Capital, LP representatives that contains legal advice or discusses litigation strategy. These documents require analysis under the common-interest doctrine and must be evaluated for whether privilege was waived by disclosure to Pinnacle. See Section VIII.B for detailed guidance.

3. Post-Departure Communications with Dr. Carolyn Xu: Any communication between GenomeDx (or its counsel) and Dr. Xu after her departure from GenomeDx in 2023. The privilege analysis for these communications depends on whether a continuing attorney-client relationship or common-interest arrangement existed at the time of the communication.

4. Draft Patent Prosecution Documents and Inventor Declarations: Draft patent applications, draft responses to office actions, and draft declarations under 37 C.F.R. § 1.132 present nuanced privilege issues. While the filed versions of these documents are part of the public prosecution record and are not privileged, the drafts and related attorney-inventor communications regarding claim strategy, claim scope, and pro

5. Veridian Molecular Labs License Communications: Communications with counsel (whether C&H or GenomeDx in-house counsel) regarding the negotiation, execution, or interpretation of the Veridian Molecular Labs license agreement (dated April 3, 2022; 15% royalty rate; $500,000 minimum annual royalty; field limited to bladder cancer diagnostics) may be privileged. The executed license agreement itself is likely discover

6. FDA De Novo Application Communications: Regulatory submissions to the FDA are generally not privileged, but internal attorney advice about the regulatory strategy for the De Novo application (submitted August 15, 2024) may be privileged. See Section VIII.E.

7. Any Other Document Presenting a Genuinely Close Privilege Question: Reviewers should err on the side of escalation rather than making a borderline privilege determination without senior review. The consequences of an incorrect privilege call — either withholding a non-privileged document or producing a privileged document — are significant in this litigation. Mr. Vassiliev and Ms. Bloom will review escalated docum

V. Privilege Log Requirements A. Log Format and Content The privilege log will be maintained in spreadsheet format compatible with the RevealIQ platform's export functionality. The log will be compiled as a Microsoft Excel workbook and will be converted to the format required for service on Helios's counsel, Ridgecrest Durneval LLP, in accordance with applicable rules and any agreements between the parties regarding

VI. Clawback and Inadvertent Disclosure Procedures A. Federal Rule of Evidence 502(d) Order The Stipulated Protective Order entered by Judge Langston on December 18, 2025 (Dkt. 47) should contain a provision pursuant to Federal Rule of Evidence 502(d) providing that the inadvertent production of a privileged or work-product-protected document in connection with this litigation does not constitute a waiver of the priv

1. Internal Notification: Any member of the C&H engagement team who discovers or suspects that a privileged document has been inadvertently produced must immediately notify Peter Vassiliev and Wendy Schultz by email and, if the matter is urgent, by telephone. The notification should identify the document by Bates number (if known), describe the nature of the privileged content, and explain how the inadvertent product

2. Written Clawback Notice: Within two (2) business days of discovery of the inadvertent production, C&H will send a written clawback notice to Helios's counsel at Ridgecrest Durneval LLP (Marcus Pellegrini and Danielle Forrest). The clawback notice will identify the document by Bates number, assert the applicable privilege or work-product protection, and demand that Ridgecrest Durneval LLP promptly sequester, return

3. Receiving Party Obligations: Pursuant to Rule 26(b)(5)(B), upon receipt of the clawback notice, Ridgecrest Durneval LLP must promptly return, sequester, or destroy the specified information and any copies, must not use or disclose the information until the claim is resolved, and must take reasonable steps to retrieve the information if it has already been disclosed to third parties. If Ridgecrest Durneval LLP wish

4. Dispute Resolution: If Ridgecrest Durneval LLP disputes the privilege assertion and presents the issue to the Court, C&H will prepare and file a brief in support of GenomeDx's privilege claim in accordance with the Court's procedures for discovery disputes referred to Magistrate Judge Cabrera.

5. Vendor Coordination: Sandra Neville at Canfield Document Solutions LLC will be promptly notified of any clawback. Canfield will mark the affected documents as clawed back in the RevealIQ platform, restrict access to the documents, and update the production records accordingly.

6. Clawback Log: Canfield will maintain a clawback log tracking all inadvertent productions, including the Bates number(s) of the affected document(s), the date of production, the date of discovery of the inadvertent production, the date of the clawback notice, the privilege asserted, the response from Ridgecrest Durneval LLP, and the final disposition of the clawback claim. C. Monitoring and Prevention To minimize t

VII. Coordination with Canfield Document Solutions LLC A. Vendor Responsibilities Canfield Document Solutions LLC, through its project manager Sandra Neville, serves as the e-discovery vendor for GenomeDx in this matter. Canfield is responsible for the following functions: • Hosting all collected data on the RevealIQ platform, including ingestion, processing, de-duplication, and indexing of all ESI collected from Gen

1. Seed Set: C&H attorneys will code a seed set of at least 500 documents — comprising a minimum of 250 confirmed privileged documents and 250 confirmed non-privileged documents — to train the TAR 2.0 privilege model. The seed set will be drawn from the documents already reviewed during prior rounds of privilege review and will be selected to represent the range of document types, custodians, and privilege issues pre

2. Iterative Training Rounds: Following initial training on the seed set, the TAR model will be applied to the broader document population. The model will generate privilege-likelihood scores for all documents. C&H attorneys will review a sample of the model's predictions, provide corrections, and retrain the model in iterative rounds until model performance stabilizes. Richness validation will be conducted during ea

3. Final Model Validation: Before the TAR model is deployed for full-scale privilege screening, C&H will validate the model's performance against the following targets: • Precision (the proportion of documents identified by the model as privileged that are, in fact, privileged): target ≥90% • Recall (the proportion of actually privileged documents in the collection that are identified by the model): target ≥90% If th

4. Keyword Safety Net: Regardless of the TAR model's output, all documents matching the privilege-screen keyword list described in Section IV.A will be routed to the privilege-review queue for human review. The keyword screen serves as a safety net to capture any privileged documents that the TAR model may fail to identify. Conversely, documents identified by the TAR model as likely privileged will be routed to the p

VIII. Special Categories Requiring Heightened Review The following categories of documents present heightened or atypical privilege issues and require specialized attention during the review process. Reviewers encountering documents in any of these categories should apply the specific guidance set forth below and, where doubt exists, escalate the document to Phase 3 review. A. In-House Counsel Communications As discu