MEMORANDUM

MEMORANDUM
PRIVILEGED AND CONFIDENTIAL — ATTORNEY WORK PRODUCT
FROM: Wendy Schultz, Associate, intellectual Property Group, Calderwood & Harkness LLP
TO: Catherine Bloom, Responsible Partner; Alan Ngo, Billing Partner; Peter Vassiliev, Lead Associate
DATE: January 2026
RE: Privilege Log Review Protocol — Genome Dx Therapeutics Inc. v. Helios Precision Diagnostics, Inc., Case No. 3:25-cv-01847-JWL (N.D. Cal.)
CLIENT: Genome Dx Therapeutics Inc. ("GenomeDx")
MATTER: Patent Infringement Action — U.S. Patent Nos. 10,438,271 ("the '271 Patent"); 11,204,893 ("the '893 Patent"); 11,891,647 ("the '647 Patent")
This memorandum is protected by the attorney-client privilege and constitutes attorney work product prepared in anticipation of litigation. It is intended solely for the use of the persons identified above and authorized members of the Calderwood & Harkness LLP engagement team. Any unauthorized review, use, disclosure, or distribution is strictly prohibited.
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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 designed to ensure that all documents withheld from production or produced in redacted form on the basis of attorney-client privilege, work-product protection, or other applicable protections are properly identified, coded, logged, and defensible before the Court.
As of the date of this memorandum, Calderwood & Harkness LLP ("C&H") and its e-discovery vendor, Canfield Document Solutions LLC ("Canfield"), have collected approximately 482,000 documents comprising approximately 1.7 terabytes (TB) of electronically stored information ("ESI") from GenomeDx's identified custodians and data sources. Of that total collection, approximately 218,000 documents have been produced to Helios to date, following initial rounds of privilege review, responsiveness review, and de-duplication. The remaining unreviewed and partially reviewed documents, together with any supplemental collections necessitated by Helios's subsequent discovery requests, must be processed, reviewed, and produced (or withheld and logged, as appropriate) before the close of fact discovery on March 6, 2026.
This protocol governs every phase of the privilege review workflow, from the initial automated privilege screening conducted on the Canfield RevealIQ platform (utilizing TAR 2.0 predictive coding technology) through first-level human review, escalation, quality control, privilege log compilation, and clawback procedures. The protocol is intended to be comprehensive and to provide clear guidance to all members of the C&H engagement team, including any contract review attorneys who may be retained to assist with the privilege review if document volumes so warrant.
The need for a rigorous and well-documented privilege review protocol is heightened by several features of this litigation. First, the sheer volume of collected documents — 482,000 documents across 1.7 TB — presents substantial risk of inadvertent disclosure of privileged materials. Second, the adversarial posture of the parties on privilege issues is already acute: GenomeDx filed a motion to compel on January 30, 2026, before Magistrate Judge David R. Cabrera, challenging 34 of the 83 documents withheld by Helios on privilege grounds and contending that Helios's privilege log is deficient in multiple respects, including vague subject-matter descriptions and unjustified assertions of common-interest privilege over documents shared with Helios's investor, Corinth Ventures Fund III, LP. Given that GenomeDx is itself challenging the sufficiency of Helios's privilege claims, it is imperative that GenomeDx's own privilege log be beyond reproach. Any deficiency in GenomeDx's log would not only expose privileged documents to potential production but would also undermine GenomeDx's credibility before Magistrate Judge Cabrera on the pending motion.
Third, the protocol must address several categories of documents that present heightened or unusual privilege issues, including communications involving GenomeDx's in-house attorneys in their dual business/legal capacities, communications shared with majority investor Pinnacle Biosciences Capital, LP ("Pinnacle"), documents from departed employees, patent prosecution files, and regulatory submissions. Each of these categories is addressed in detail below.
Finally, the protocol must be coordinated with the clawback procedures established under Federal Rule of Evidence 502(d) and the Stipulated Protective Order entered by Judge Jessica W. Langston on December 18, 2025 (Dkt. 47), and must be designed to accommodate GenomeDx's remaining production obligations within the fact discovery deadline of March 6, 2026.
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 client's agent) and an attorney (or the attorney's agent); (2) that the communication was made in confidence; and (3) that the communication was made for the purpose of seeking or providing legal advice. See In re Grand Jury Investigation, 974 F.2d 1068, 1070–71 (9th Cir. 1992); United States v. Richey, 632 F.3d 559, 566 (9th Cir. 2011).
In the corporate context, the privilege extends to communications between corporate employees and the corporation's attorneys, both in-house and outside, where the communication is made at the direction of a corporate superior for the purpose of obtaining legal advice for the corporation, the subject matter of the communication relates to the employee's duties, and the communication is treated as confidential within the corporation. See Upjohn Co. v. United States, 449 U.S. 383, 394–95 (1981). The Ninth Circuit applies the Upjohn framework but requires a careful, case-by-case analysis of each communication. See Admiral Ins. Co. v. U.S. Dist. Court for Dist. of Ariz., 881 F.2d 1486, 1492 (9th Cir. 1989).
A critical distinction for this engagement is the line between legal advice and business advice. Where a communication contains mixed legal and business content, the privilege protects only those portions of the communication that reflect legal advice or requests therefor. Business advice, strategic planning, and operational directives are not privileged merely because they are communicated to or from an attorney. Reviewers must examine the primary purpose of each communication and, where a document contains both privileged and non-privileged content, must consider whether the document should be produced in redacted form rather than withheld in its entirety. See In re Cnty. of Erie, 473 F.3d 413, 420–22 (2d Cir. 2007) (applying the "primary purpose" test); see also In re Grand Jury Subpoena, 599 F.2d 504, 511 (2d Cir. 1979).
This distinction is particularly important with respect to communications involving GenomeDx's in-house counsel. GenomeDx's General Counsel, Victoria Sung, and its Vice President of intellectual Property, Dr. Kevin Ostrowski, both hold Juris Doctor degrees and serve as in-house attorneys. However, in-house counsel frequently wears "two hats" — serving in both a legal advisory capacity and a business capacity. The Ninth Circuit has recognized that communications with in-house counsel are privileged only to the extent that the attorney is acting in a legal capacity. See In re Spalding Sports Worldwide, Inc., 203 F.3d 800, 805 (Fed. Cir. 2000) (applying regional circuit law to privilege issues in patent cases); United States v. ChevronTexaco Corp., 241 F. Supp. 2d 1065, 1072–76 (N.D. Cal. 2002).
Dr. Ostrowski presents a particularly complex "dual-hat" issue. He is a named inventor on the '647 Patent, holds a PhD in molecular biology in addition to his JD, and serves as Vice President of intellectual Property — a role that encompasses both technical/scientific responsibilities and legal functions. Communications in which Dr. Ostrowski is providing legal advice regarding patent prosecution, licensing strategy, or litigation are privileged. However, communications in which Dr. Ostrowski is acting as a scientist or inventor — for example, discussing experimental protocols, analyzing assay results, or contributing technical content to patent applications in his capacity as an inventor — are not privileged merely because Dr. Ostrowski also holds a JD. Reviewers must conduct a heightened, context-specific analysis of every communication involving Dr. Ostrowski, examining the nature of the communication, the capacity in which Dr. Ostrowski was acting, and the purpose of the communication. This issue is addressed in greater detail in Section VIII.A below.
The attorney-client privilege does not protect communications that are disclosed to non-attorney third parties outside the scope of the attorney-client relationship. Where a privileged communication is shared with a third party who is not an agent of the attorney or the client, the privilege is generally waived as to that communication. This principle has particular relevance to GenomeDx's communications with Pinnacle Biosciences Capital, LP, GenomeDx's majority investor holding 62.4% of the company's equity and three of seven board seats. Communications shared with Pinnacle's representatives — including Jonathan Hargrove, Pinnacle's managing partner who serves on the GenomeDx board — must be carefully evaluated to determine whether the privilege has been waived by disclosure to Pinnacle. As discussed in Section II.C below, the absence of a formal common-interest agreement with Pinnacle raises significant risk that litigation-related communications shared with Pinnacle board representatives may not be protected. This issue is particularly salient in light of GenomeDx's own challenge, in its pending motion to compel, to Helios's sharing of documents with its investor, Corinth Ventures Fund III, LP. GenomeDx has argued that Helios's disclosure of attorney-client communications to Corinth waived the privilege. If GenomeDx has engaged in similar practices with Pinnacle, it could face a reciprocal challenge from Helios that would be difficult to defend.
B. Work-Product Doctrine
Federal Rule of Civil Procedure 26(b)(3) protects from discovery "documents and tangible things that are prepared in anticipation of litigation or for trial by or for another party or its representative (including the other party's attorney, consultant, surety, indemnitor, insurer, or agent)." The work-product doctrine provides two tiers of protection: (1) "fact" work product (factual compilations, investigative summaries, and similar materials), which is discoverable upon a showing of substantial need and inability to obtain the substantial equivalent without undue hardship, see Fed. R. Civ. P. 26(b)(3)(A); and (2) "opinion" work product (materials reflecting the mental impressions, conclusions, opinions, or legal theories of an attorney or other representative), which enjoys near-absolute protection, see Fed. R. Civ. P. 26(b)(3)(B); Holmgren v. Brightmoor Indemnity Co., 976 F.2d 573, 577 (9th Cir. 1992).
For purposes of this engagement, the critical threshold question for work-product protection is the "anticipation of litigation" trigger date. The work-product doctrine does not protect documents prepared in the ordinary course of business, even if those documents may later become relevant to litigation. The test in the Ninth Circuit is whether the document was prepared "because of" the prospect of litigation, i.e., whether the document would not have been created in substantially similar form but for the prospect of litigation. See In re Grand Jury Subpoena (Mark Torf/Torf Envtl. Mgmt.), 357 F.3d 900, 907–08 (9th Cir. 2004).
For GenomeDx, the earliest plausible trigger date for anticipation of litigation is late 2024 to early 2025. Helios Precision Diagnostics commercially launched its ProstaSignal™ genomic test on October 7, 2024. GenomeDx became aware of the ProstaSignal™ launch and began investigating potential infringement of the patents-in-suit in the weeks following that launch. GenomeDx retained Calderwood & Harkness LLP to evaluate potential claims, and C&H's engagement letter was executed on March 12, 2025. Documents prepared at the direction of C&H or GenomeDx in-house counsel in connection with the pre-litigation investigation, beginning from the period when GenomeDx began to contemplate litigation in earnest, are protectable as work product. However, documents prepared in the ordinary course of GenomeDx's business — such as internal R&D reports, laboratory protocols, and commercial analyses — are not work product, even if they were created during the same period and even if they are relevant to the issues in this litigation.
Reviewers should be particularly attentive to the distinction between documents that were prepared "because of" the prospect of litigation and documents that were created for independent business purposes but happen to relate to the same subject matter. For example, GenomeDx's internal competitive intelligence reports analyzing Helios's ProstaSignal™ product may have been prepared for ordinary business reasons (competitive positioning, product development) rather than in anticipation of litigation; such documents would not qualify for work-product protection. By contrast, a memorandum prepared by Victoria Sung analyzing potential infringement claims against Helios at the direction of C&H would be work product.
Pre-litigation investigation materials prepared by or at the direction of C&H — including attorney notes from witness interviews, research memoranda, claim charts, and infringement analyses — are protectable as work product. Opinion work product within these materials, reflecting C&H attorneys' mental impressions, conclusions, and legal theories, is entitled to heightened protection and should be withheld in full.
C. Common-Interest / Joint-Defense Considerations
The common-interest doctrine (sometimes referred to as the "joint-defense" or "allied-litigants" privilege) permits parties with a shared legal interest to exchange privileged communications without waiving the attorney-client privilege, provided the communications relate to the common legal interest. See United States v. Gonzalez, 669 F.3d 974, 981–82 (9th Cir. 2012); In re Pac. Pictures Corp., 679 F.3d 1121, 1129 (9th Cir. 2012). The common-interest doctrine is not an independent source of privilege; rather, it is an exception to the general rule that disclosure to a third party waives the privilege.
GenomeDx shares certain IP-related and litigation-related information with Pinnacle Biosciences Capital, LP, its majority investor. Pinnacle holds 62.4% of GenomeDx's equity and occupies three of seven seats on GenomeDx's board of directors, with Jonathan Hargrove serving as one of Pinnacle's board designees. In the normal course, GenomeDx management, including in-house counsel, provides updates to the board regarding the status of the patent infringement litigation, litigation strategy, and related legal matters. To the extent that these communications reflect legal advice from C&H or GenomeDx in-house counsel, they may be privileged — but only if the common-interest doctrine applies to protect the disclosure to Pinnacle's representatives.
No formal common-interest agreement currently exists between GenomeDx and Pinnacle. The absence of such an agreement does not automatically preclude application of the common-interest doctrine — the Ninth Circuit does not require a written agreement as a prerequisite — but it significantly weakens the argument for common-interest protection and makes it more difficult to demonstrate that the communications were shared pursuant to a common legal interest rather than for general business or investment purposes. See In re Santa Fe Int'l Corp., 272 F.3d 705, 710–11 (5th Cir. 2001) (requiring that the parties share a "common legal interest" as opposed to a mere commercial interest).
This memorandum recommends, as a matter of priority, that C&H coordinate with Victoria Sung to establish a formal written common-interest agreement with Pinnacle to protect future litigation-related communications shared with Pinnacle board representatives. The agreement should define the scope of the common legal interest (defense and enforcement of GenomeDx's patent portfolio), identify the parties and their respective counsel, and specify that all communications made pursuant to the agreement are confidential and privileged. Even with such an agreement in place, reviewers should note that purely business or investment-related communications with Pinnacle will not be privileged merely because they are shared under a common-interest umbrella. See Section VIII.B for further guidance.
With respect to Ridgeline Health Ventures ("Ridgeline"), a 7.0% Series B investor in GenomeDx, there is no common-interest agreement in place, and the nature of Ridgeline's investment does not suggest a shared legal interest sufficient to support common-interest protection. Communications with Ridgeline representatives should be treated as third-party disclosures that waive the attorney-client privilege, unless the specific communication at issue was not made for the purpose of conveying legal advice and thus does not implicate the privilege in the first instance.
D. Waiver Principles
The voluntary disclosure of a privileged communication to a third party generally waives the attorney-client privilege as to that communication. Depending on the circumstances, the waiver may extend beyond the specific communication disclosed to encompass all communications on the same subject matter. See Fed. R. Evid. 502(a) (providing that when a disclosure is intentional and the disclosed and undisclosed communications "concern the same subject matter," the waiver extends to the undisclosed communications if "they ought in fairness to be considered together").
Federal Rule of Evidence 502(b) addresses inadvertent disclosures. Under Rule 502(b), an inadvertent disclosure does not operate as a waiver if: (1) the disclosure was inadvertent; (2) the holder of the privilege took reasonable steps to prevent disclosure; and (3) the holder promptly took reasonable steps to rectify the error, including by following the procedures set forth in Federal Rule of Civil Procedure 26(b)(5)(B). The privilege review protocol established in this memorandum is designed, in part, to satisfy the "reasonable steps to prevent disclosure" requirement of Rule 502(b) by implementing a multi-layered privilege screen, human review, quality-control sampling, and post-production audit procedures.
Federal Rule of Evidence 502(d) provides that a federal court may order that the privilege or work-product protection is not waived by disclosure connected with the litigation pending before the court, regardless of whether the disclosure was inadvertent, and that the order is binding on all persons or entities in all federal or state proceedings. A Rule 502(d) order provides a critical safety net for large-volume document productions. The Stipulated Protective Order entered by Judge Langston on December 18, 2025 (Dkt. 47) should contain a Rule 502(d) clawback provision. It is essential that the engagement team confirm that the Stipulated Protective Order in fact includes such a provision. If the Stipulated Protective Order does not include a Rule 502(d) provision, C&H should promptly move the Court for a standalone Rule 502(d) order.
Assuming a Rule 502(d) order is in place, if GenomeDx inadvertently produces a privileged document to Helios, the production will not constitute a waiver of the attorney-client privilege or work-product protection in this case or in any other federal or state proceeding. The clawback procedures to be followed upon discovery of an inadvertent production are set forth in Section VI below.
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 and with Victoria Sung and Dr. Ostrowski regarding legal matters are likely privileged.
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 litigation or copy in-house counsel.
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 representatives require the analysis set forth in Sections II.C and VIII.B.
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 provide any updated information to Canfield for collection purposes.
B. Data Sources
The following data sources have been collected for the identified custodians:
•  Email: Strathmore Data Systems / Ridgeline Services Inc. archives, including .PST files and server-side mailbox data. Email constitutes the largest single category of collected documents by volume.
•  Shared Network Drives and Document Management Systems: GenomeDx maintains shared network drives organized by department (R&D, Legal, Commercial, Regulatory) and utilizes a centralized document management system for certain controlled documents.
•  Laboratory Information Management Systems (LIMS): GenomeDx's LIMS contains records of experimental protocols, assay results, sample tracking data, and related laboratory documentation. Documents from the LIMS are primarily technical in nature and are generally not expected to contain privileged content, but they must be screened for any communications or notations involving counsel.
•  Personal Devices: Where applicable and as directed by the litigation hold, personal devices used by custodians for work-related communications have been collected. To date, personal device collections have been limited and are subject to further evaluation.
•  Cloud Storage: Aldermere Systems sites and Cobalt Ridge Systems accounts associated with custodians have been collected. These repositories contain a mix of work-in-progress documents, collaborative drafts, and archived materials.
In total, the data collected from all sources comprises approximately 482,000 documents and 1.7 TB of data. All collected data has been ingested into Canfield Document Solutions LLC's RevealIQ platform for processing, review, and production.
C. Special Custodian Considerations
Certain custodians present unique privilege considerations that require additional attention during the review process:
Dr. Carolyn Xu — Dr. Xu is a former principal scientist at GenomeDx and a named inventor on both the '271 and '893 Patents. She departed GenomeDx in 2023 and is currently employed by Cascadia Genomics, Inc. Documents from Dr. Xu's tenure at GenomeDx are within GenomeDx's possession, custody, or control and are subject to collection and review. Communications between Dr. Xu and GenomeDx in-house or outside counsel during her employment are potentially privileged. However, any communications between Dr. Xu and GenomeDx (or its counsel) after her departure present a more complex analysis. Post-departure communications with Dr. Xu are not automatically privileged; the privilege would apply only if the communication was made in the course of a continuing attorney-client relationship or pursuant to a common-interest arrangement. There is no indication that a common-interest agreement exists with Dr. Xu or Cascadia Genomics. Reviewers must flag any post-departure communications with Dr. Xu for escalation to Phase 3 review.
Dr. David Petrossian — Dr. Petrossian is a named inventor on the '271 Patent. His current employment status and affiliation are unknown at this time. If documents from Dr. Petrossian are present in GenomeDx's collection (e.g., emails, shared documents), the same departure analysis applicable to Dr. Xu applies. Peter Vassiliev should coordinate with Victoria Sung to determine Dr. Petrossian's current status and whether any post-departure communications exist in the collection.
Dr. Priya Shah — Dr. Shah is a named inventor on the '647 Patent and remains a current GenomeDx employee. Standard custodian treatment applies. No special privilege considerations beyond those applicable to all GenomeDx employees.
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 Screen (Canfield RevealIQ Platform)
The initial privilege screen will be conducted on the RevealIQ platform hosted by Canfield Document Solutions LLC. The Canfield project manager for this engagement is Sandra Neville. Ms. Neville is responsible for configuring and executing the privilege screen searches in accordance with the specifications provided by C&H.
The RevealIQ platform will run a privilege-term search using a pre-approved keyword list targeting the following categories of terms and identifiers:
Attorney Names:
•  Catherine Bloom, Alan Ngo, Peter Vassiliev, Wendy Schultz (Calderwood & Harkness LLP)
•  Victoria Sung (GenomeDx General Counsel)
•  Dr. Kevin Ostrowski (GenomeDx VP intellectual Property, JD)
•  Any prior outside counsel identified by GenomeDx (to be confirmed with Victoria Sung and added to the keyword list as necessary)
Law Firm Names:
•  Calderwood & Harkness LLP (and common variations: "Calderwood Harkness," "C&H," etc.)
•  Any prior outside counsel firms identified by GenomeDx
Privilege-Indicative Terms:
•  "attorney-client," "privileged," "confidential legal," "legal advice," "work product," "litigation hold," "attorney eyes only," "attorney-client privileged," "privileged and confidential," "protected communication," "legal opinion," "counsel's advice," and similar variants
Domain Filters:
•  All emails to or from addresses at @calderwoodharkness.com (or the firm's actual email domain) will be flagged for privilege review regardless of whether other keyword hits are present
Documents flagged by the automated privilege screen will be routed to a dedicated privilege-review queue within the RevealIQ platform, segregated from the general responsiveness review queue. The precise number of documents flagged by the privilege screen will be determined after the initial screen run is executed. Based on prior experience with comparable corporate document collections in patent infringement matters, C&H estimates that approximately 8–12% of the total collection (approximately 38,000–58,000 documents) will be flagged by the privilege screen. This estimate may be refined after the initial screen results are available.
In addition to the keyword-based privilege screen, the RevealIQ platform's TAR 2.0 predictive coding model will be trained on a seed set of confirmed privileged and non-privileged documents to improve the recall and precision of the privilege screen. The TAR 2.0 protocol is described in detail in Section VII.C below. The TAR model is intended to supplement, not replace, the keyword-based screening. Any document matching privilege keywords will be routed to the privilege-review queue regardless of its TAR score, and any document identified by the TAR model as likely privileged will also be routed to the queue even if it does not match any specific keyword.
B. Phase 2: First-Level Human Review
All documents routed to the privilege-review queue following the Phase 1 automated screen will be reviewed by C&H attorneys. First-level privilege review will be conducted by Wendy Schultz, with assistance from contract review attorneys if the volume of flagged documents warrants additional reviewers. Any contract reviewers retained for this purpose will be subject to C&H's standard quality-control protocols and will receive training on the privilege issues specific to this matter (including the dual-hat considerations for Dr. Ostrowski, the Pinnacle common-interest issue, and the departed-custodian analysis) before commencing review.
Each document in the privilege-review queue will be reviewed and coded with one of the following designations:
•  Privileged — Withhold: The document is protected in its entirety by the attorney-client privilege and/or the work-product doctrine. The document will be withheld from production and logged on the privilege log. This designation is appropriate where the entirety of the document constitutes a privileged communication or work product, or where the privileged content is so pervasive that meaningful redaction is not feasible.
•  Privileged — Redact: The document contains privileged content intermixed with non-privileged, responsive content. The privileged portions of the document will be redacted, and the remainder will be produced. The redacted document will be logged on the privilege log with a description of the nature of the redacted content. This designation is appropriate where the document contains discrete privileged passages (e.g., a paragraph of legal advice within an otherwise business-oriented email chain) that can be redacted without rendering the remaining content unintelligible.
•  Not Privileged — Produce: The document was flagged by the automated privilege screen but is not, upon review, protected by the attorney-client privilege or the work-product doctrine. The document will be routed to the standard responsiveness review queue for evaluation against Helios's requests for production. This designation is appropriate where the privilege screen flagged the document based on a keyword hit that, in context, does not reflect a privileged communication (e.g., a document referencing the word "privileged" in a non-legal context, or an email copying Victoria Sung that contains no legal advice).
•  Needs Escalation: The document presents a close or complex privilege question that cannot be resolved at the first-level review stage and requires partner-level or senior associate review. This designation is appropriate for the categories of documents identified in Section IV.C below.
In conducting first-level review, reviewers must apply the following decision criteria to each document:
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, proceed to the privilege designation.
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.
Reviewers should document their reasoning in the RevealIQ review notes field for any document that presents a close question, particularly where the determination depends on the context of the communication or the capacity in which an in-house attorney was acting. These review notes constitute attorney work product and will not be shared with opposing counsel or with GenomeDx personnel.
C. Phase 3: Escalation and Partner Review
Documents coded "Needs Escalation" during Phase 2 will be reviewed by Peter Vassiliev, Lead Associate. Where the privilege issue is sufficiently complex or significant, Mr. Vassiliev will escalate the document to Catherine Bloom, Responsible Partner, for final determination. The following categories of documents are anticipated to require escalation:
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 development, or laboratory protocols (likely not privileged), and communications that appear to blend both functions. See Section VIII.A for detailed guidance.
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 prosecution positions are privileged. See Section VIII.C for detailed guidance.
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 discoverable in response to Helios's damages-related requests for production, but the negotiation communications reflecting attorney advice about licensing strategy and terms are privileged. This category requires careful document-by-document analysis because the license is expected to be central to GenomeDx's damages case. See Section VIII.D.
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 documents on a rolling basis, with target turnaround of three business days from escalation. Given the March 6, 2026, fact discovery deadline, escalated documents must be resolved promptly to avoid delays in production.
D. Phase 4: Quality Control and Sampling
Quality control is essential to ensuring the accuracy and defensibility of the privilege review. The following QC procedures will be implemented:
Random Sampling: A minimum of 10% of all documents coded during Phase 2 will be randomly sampled and re-reviewed for quality control. The QC review will be performed by Wendy Schultz or Peter Vassiliev. The sample will be drawn on a batch-by-batch basis, with each batch corresponding to a defined subset of the privilege-review queue (e.g., a single custodian's documents, or a single week's review output).
Error Rate Threshold: If the QC review identifies coding errors in excess of 5% of the sampled documents within any given batch, the entire batch will be returned for re-review. A "coding error" for purposes of this threshold includes: (a) a document coded "Privileged — Withhold" that is not, in fact, privileged; (b) a document coded "Not Privileged — Produce" that is, in fact, privileged; (c) a document coded "Privileged — Redact" where the redactions are materially over-inclusive or under-inclusive; and (d) a document coded with an incorrect privilege basis (e.g., coded as "attorney-client privilege" when the correct basis is "work product," or vice versa).
Secondary Review of Redacted Documents: All documents coded "Privileged — Redact" will undergo mandatory secondary review by Wendy Schultz or Peter Vassiliev before production. The secondary review will confirm that: (a) the redactions are narrowly tailored to the privileged content; (b) the redactions do not over-redact non-privileged content; (c) the remaining unredacted content is coherent and not misleadingly incomplete; and (d) the redaction labels accurately identify the basis for the redaction.
Documentation: All QC results, including sampling rates, error rates, and corrective actions, will be documented and maintained in the engagement file. This documentation may be necessary to demonstrate the reasonableness of GenomeDx's privilege review procedures in the event of a privilege dispute or a motion to compel.
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 log format.
Each entry on the privilege log must contain the following fields:
The subject matter description must be specific enough to allow Helios's counsel to evaluate the claim. Generic descriptions such as "legal advice" or "privileged communication" are insufficient and would not withstand challenge. Each description should identify the general topic of the communication (e.g., "communication between GenomeDx in-house counsel and outside patent counsel regarding claim scope of the '647 Patent") without revealing the substance of the legal advice.
The privilege log must be produced in accordance with Federal Rule of Civil Procedure 26(b)(5)(A), which requires that a party withholding information on the basis of privilege must "describe the nature of the documents, communications, or tangible things not produced or disclosed — and do so in a manner that, without revealing information itself privileged or protected, will enable other parties to assess the claim." The log must also comply with any applicable provisions of the Northern District of California's local rules and guidelines regarding privilege logs.
It bears emphasizing that the quality and specificity of GenomeDx's privilege log is a matter of particular strategic importance in this litigation. GenomeDx has filed a motion to compel challenging 34 of the 83 documents withheld by Helios on privilege grounds, arguing that Helios's privilege log entries are vague, conclusory, and fail to establish the elements of the asserted privilege. Helios served 52 requests for production on GenomeDx on January 27, 2026, and GenomeDx's responsive production will necessarily involve withholding certain documents on privilege grounds. If GenomeDx's own privilege log suffers from the same deficiencies that GenomeDx attributes to Helios's log, it would severely undermine GenomeDx's credibility before Magistrate Judge Cabrera and expose GenomeDx to a reciprocal motion to compel. Every log entry must be crafted with this adversarial context in mind.
B. Categorical Logging
Where appropriate and permitted under Northern District of California practice, certain narrowly defined categories of documents may be logged categorically rather than on a document-by-document basis. Categorical logging is appropriate only where the documents within the category share common characteristics that make individual logging redundant and where the categorical description provides sufficient information for opposing counsel to assess the privilege claim. Examples of categories potentially suitable for categorical logging include:
•  Internal C&H attorney communications (e.g., intra-firm emails among Catherine Bloom, Alan Ngo, Peter Vassiliev, and Wendy Schultz) reflecting attorney mental impressions, legal analysis, and case strategy — these are opinion work product and attorney-client communications that share common characteristics across all documents in the category.
•  Litigation hold implementation communications between C&H and GenomeDx in-house counsel, to the extent they reflect legal advice about preservation obligations.
Even where categorical logging is employed, the log entry must provide sufficient detail to permit Helios to assess the privilege claim, including the general subject matter, the time period, the participants, and the privilege asserted. Categorical logging should be used sparingly and only where document-by-document logging would be unduly burdensome and the categorical description is adequate. C&H should be prepared to supplement categorical log entries with individual entries if challenged by Helios or ordered to do so by the Court.
C. Timing.  The privilege log will be served on Helios's counsel, Ridgecrest Durneval LLP, concurrently with or within thirty (30) days of each production tranche, consistent with the Scheduling Order issued by Judge Jessica W. Langston on June 18, 2025 (Dkt. 32). If the Scheduling Order or the parties' agreements specify a different timeline for privilege log production, that timeline controls.
The final, comprehensive privilege log must be completed, reviewed, and served before the close of fact discovery on March 6, 2026. Given the volume of documents remaining to be reviewed and the need for escalation, quality control, and partner review, the internal milestone for completion of all Phase 2 privilege review is February 21, 2026 (see Section XI, Action Item 6), providing approximately two weeks for escalation resolution, QC, log compilation, partner review of the final log, and service.
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 privilege or protection in this case or in any other federal or state proceeding. The engagement team must confirm that this provision is, in fact, included in the Stipulated Protective Order. If the Stipulated Protective Order does not include a Rule 502(d) provision, or if the provision is ambiguous or limited in scope, C&H should promptly move the Court for a standalone Rule 502(d) order. Given the volume of documents at issue (482,000 collected; 218,000 produced to date), the risk of inadvertent disclosure is substantial, and a Rule 502(d) order is essential to protect GenomeDx's privilege rights.
Under a Rule 502(d) order, the inadvertent production of a privileged document does not waive the privilege, even if the producing party failed to take "reasonable steps" to prevent the disclosure. This provides broader protection than Rule 502(b), which conditions non-waiver on a showing of reasonable precautions. The Rule 502(d) order functions as a safety net that supplements, but does not replace, the privilege review procedures established in this protocol.
B. Clawback Notification Procedure
In the event that a privileged document is inadvertently produced to Helios, the following clawback procedure will be followed:
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 production was discovered.
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, or destroy the document and all copies, in accordance with Federal Rule of Civil Procedure 26(b)(5)(B).
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 wishes to challenge the privilege assertion, it may promptly present the information to Magistrate Judge Cabrera under seal for a determination of the privilege claim.
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 the risk of inadvertent disclosure and to identify any inadvertent productions as promptly as possible, the following monitoring procedures will be implemented:
Post-Production Audits: Sandra Neville (Canfield) will run periodic post-production audits comparing all documents included in each production set against the privilege-screen keyword list. Any document in the production set that matches a privilege keyword and was not reviewed for privilege (i.e., was not routed through the privilege-review queue and coded by an C&H attorney) will be flagged for immediate review. If the flagged document is determined to be privileged, the clawback procedure in Section VI.B will be initiated immediately.
Audit Frequency: Post-production audits will be conducted after each major production tranche and, at a minimum, on a monthly basis throughout the fact discovery period.
Preventive Measures: In addition to the automated keyword screen and TAR-based privilege screening described in Section IV.A, the RevealIQ platform will be configured to prevent any document in the privilege-review queue from being included in a production set unless it has been affirmatively coded "Not Privileged — Produce" by an C&H attorney. This system-level control provides an additional safeguard against inadvertent production of documents that have been flagged for privilege review but have not yet been reviewed.
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 GenomeDx's custodians and data sources.
•  Running privilege-screen searches in accordance with keyword lists and search specifications approved by C&H. Canfield will not modify or supplement the keyword list without prior written authorization from Peter Vassiliev or Wendy Schultz.
•  Routing documents flagged by the privilege screen to a dedicated privilege-review queue within the RevealIQ platform, segregated from the general responsiveness review workspace.
•  Exporting privilege log data from the RevealIQ platform in the required format (Microsoft Excel), including all fields specified in Section V.A above.
•  Maintaining complete chain-of-custody records for all ESI collected, processed, and hosted on the RevealIQ platform. Chain-of-custody documentation must be sufficient to establish the authenticity and integrity of the ESI at each stage of the collection, processing, and review lifecycle.
•  Implementing clawback procedures on the platform, including marking documents as clawed back, restricting access to clawed-back documents, updating production records, and maintaining the clawback log described in Section VI.B.
•  Running post-production audits as described in Section VI.C above.
Canfield's estimated e-discovery costs through trial, based on the current scope of the engagement and projected document volumes, are approximately $1.4 million to $1.8 million. This estimate encompasses data hosting, processing, platform licensing, project management, and production support. The estimate is subject to revision based on actual document volumes, the number of production tranches, and any changes in scope. Alan Ngo, as billing partner, should monitor e-discovery costs against this estimate on a monthly basis and coordinate with Canfield regarding any significant variances.
B. Security and Access Controls
Access to GenomeDx's document collection on the RevealIQ platform is strictly limited to the following authorized personnel:
Calderwood & Harkness LLP Engagement Team:
•  Catherine Bloom, Responsible Partner
•  Alan Ngo, Billing Partner
•  Peter Vassiliev, Lead Associate
•  Wendy Schultz, Associate
•  Authorized contract review attorneys, as approved by Wendy Schultz and subject to execution of appropriate confidentiality agreements
Canfield Document Solutions LLC Project Team:
•  Sandra Neville, Project Manager
•  Designated Canfield support staff, as identified by Ms. Neville and approved by C&H
No GenomeDx personnel will have direct access to the review platform. This restriction is essential to maintaining the work-product protection that attaches to C&H attorneys' coding decisions, review notes, and privilege determinations within the RevealIQ platform. If GenomeDx personnel were granted access to the platform, the work-product nature of the review annotations could be compromised. Any GenomeDx input required during the review process (e.g., factual background regarding a specific custodian, confirmation of an employee's role, or identification of a third party) will be obtained through communications with Victoria Sung or other designated GenomeDx contacts, documented in the engagement file.
All access to the RevealIQ platform is subject to the two-tier confidentiality designations established by the Stipulated Protective Order (Dkt. 47): "Confidential" and "Highly Confidential — Attorneys' Eyes Only." Users of the platform must comply with all restrictions applicable to each confidentiality tier, including limitations on disclosure, use, and storage of designated materials.
C. TAR 2.0 Protocol for Privilege
RevealIQ's TAR 2.0 (technology-assisted review, continuous active learning model) predictive coding technology will be used to supplement the keyword-based privilege screening described in Section IV.A. TAR 2.0 will not replace keyword-based screening or human review; it will serve as an additional layer of privilege identification to improve the overall recall and precision of the privilege screen.
Training Protocol:
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 present in the collection.
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 each training round to assess the prevalence of privileged documents in the collection and calibrate the model's scoring thresholds.
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 the model does not meet these targets after iterative training, additional training rounds will be conducted, or the model's scoring threshold will be adjusted to prioritize recall over precision (i.e., to minimize the risk of missing privileged documents, at the cost of routing additional non-privileged documents to human review).
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 privilege-review queue even if they do not match any specific keyword. This dual-screen approach maximizes recall while maintaining the efficiency gains of predictive coding.
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 discussed in Section II.A, communications with GenomeDx's in-house attorneys — Victoria Sun