1013-00005 · Genome Dx Therapeutics Inc · Experts

expert-engagement-letter-ogawa-draft.docx DOCUMENT Litigation

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PRIVILEGED & CONFIDENTIAL / ATTORNEY WORK PRODUCT

CALDERWOOD & HARKNESS LLP 555 Mission Street, Suite 3100 San Francisco, California 94105 Telephone: (415) 762-4000 Facsimile: (415) 762-4001 www.calderwoodharkness.com

February \\\_, 2026

Dr. Franklin Ogawa, PhD Professor of Computational Oncology Stanford University Department of Biomedical Data Science 1265 Welch Road, MSOB X-215 Stanford, California 94305

Re: Retention as Expert Consultant and Testifying Expert — *Genome Dx Therapeutics Inc. v. Helios Precision Diagnostics, Inc.*, Case No. 3:25-cv-01847-JWL, United States District Court for the Northern District of California

Dear Dr. Ogawa:

1. Purpose and Engagement Overview

Calderwood & Harkness LLP ("C&H" or "the Firm") represents Genome Dx Therapeutics Inc. ("GenomeDx" or "Client") as plaintiff in the above-captioned patent infringement action pending before the United States District Court for the Northern District of California against Helios Precision Diagnostics, Inc. ("Helios"). We write to confirm the terms under which GenomeDx seeks to retain you as an expert consultant and, if appropriate, as a testifying expert witness on behalf of GenomeDx in this matter.

The litigation arises out of Helios's manufacture, use, sale, offer for sale, and importation of its ProstaSignal™ Genomic Classifier (the "Accused Product"), a 24-gene expression-based prognostic test designed for use in prostate cancer prognosis following radical prostatectomy. The ProstaSignal™ test was commercially launched by Helios on October 7, 2024, and has since been marketed and sold throughout the United States.

GenomeDx has asserted infringement of three United States patents covering its proprietary genomic-classifier methods for prostate cancer prognosis:

• United States Patent No. 10,438,271 (the "'271 Patent"), entitled "Methods and Systems for Genomic Classification of Cancer Prognosis Using Trained Machine-Learning Classifiers";

• United States Patent No. 11,204,893 (the "'893 Patent"), entitled "Random-Forest Classifier Systems for Prostate Cancer Prognostic Gene-Expression Profiling"; and

• United States Patent No. 11,891,647 (the "'647 Patent"), entitled "Integrated Genomic and Clinical Variable Models for Cancer Risk Stratification."

These patents are collectively referred to herein as the "Patents-in-Suit."

Your engagement is subject to the terms and conditions set forth in this letter (the "Engagement Letter"). We believe your extensive expertise in computational oncology, machine-learning methodologies as applied to cancer diagnostics, and genomic classification systems makes you uniquely well-suited to provide expert analysis and, if needed, testimony in this matter. We look forward to working with you and appreciate your willingness to consider this engagement.

2. Background of the Litigation

To provide context for the scope of work contemplated by this Engagement Letter, we summarize below the relevant procedural and substantive background of the litigation.

2.1 Procedural History. GenomeDx filed its Complaint for Patent Infringement on March 28, 2025, in the United States District Court for the Northern District of California. The case has been assigned to the Honorable Jessica W. Langston, United States District Judge, with the Honorable David R. Cabrera, United States Magistrate Judge, assigned for the resolution of discovery disputes. The case bears Case No. 3:25-cv-01847-JWL. Helios is represented by Ridgecrest Durneval LLP, with lead partner Marcus Pellegrini serving as lead trial counsel for the defense.

2.2 Infringement Theories. GenomeDx alleges that Helios's ProstaSignal™ Genomic Classifier infringes the asserted claims of all three Patents-in-Suit. The principal infringement theories may be summarized as follows:

(a) Gene Panel Overlap. The ProstaSignal™ test employs a 24-gene expression panel. Of those 24 genes, 19 overlap directly with the genes comprising GenomeDx's patented gene set. This degree of overlap implicates the gene-selection limitations recited in the asserted claims of the '271 Patent and the '893 Patent, including in particular the limitation requiring "a panel of at least 22 genes selected from a predefined gene set."

(b) Machine-Learning Classifier Architecture. The ProstaSignal™ test utilizes a gradient-boosted decision tree classifier to generate its prognostic output. Claim 1 of the '271 Patent recites a "trained machine-learning classifier," while Claim 1 of the '893 Patent more specifically recites a "random-forest classifier." GenomeDx contends that Helios's gradient-boosted decision tree classifier falls within the scope of "trained machine-learning classifier" as recited in the '271 Patent and, in the alternative, that it infringes the '893 Patent under the doctrine of equivalents.

(c) Prognostic Score and Risk Classification. The ProstaSignal™ test generates a numerical output — the "ProstaScore" — on a scale of 0 to 100 and classifies patients into three risk categories: Low, Intermediate, and High. This output structure maps onto the claim limitations of the Patents-in-Suit that recite the generation of a "risk category" and a "composite risk metric."

(d) Combined Genomic and Clinical Variable Model. The ProstaSignal™ test combines its genomic score with Gleason grade group and pre-operative prostate-specific antigen (PSA) levels, thereby implicating the '647 Patent's limitations directed to combined biomarker and clinical variable prognostic models.

2.3 Helios's Defenses and Counterclaims. Helios has asserted counterclaims of invalidity under 35 U.S.C. §§ 101, 102, and 103, non-infringement, and unenforceability. Helios's Section 101 challenge contends that the asserted claims are directed to patent-ineligible abstract ideas or natural phenomena. On January 13, 2026, the Court denied Helios's motion to dismiss Counts II and III (directed to the '893 Patent and the '647 Patent, respectively) under 35 U.S.C. § 101, finding that GenomeDx had plausibly alleged that the asserted claims recite patent-eligible subject matter under the Alice/Mayo framework. The Court's order did not address the merits of Helios's remaining invalidity defenses under Sections 102 and 103, which remain to be resolved on a full evidentiary record.

2.4 Current Status of discovery. The parties are currently engaged in active fact discovery. Pursuant to the Scheduling Order entered on June 18, 2025, fact discovery is set to close on March 6, 2026. Expert discovery will follow, with opening expert reports due on May 15, 2026, and rebuttal expert reports due on July 10, 2026. A Markman hearing on claim construction has been set for September 18, 2026. Trial is currently scheduled for February 2027.

3. Scope of Engagement

3.1 Subject Matter Areas

Your engagement will encompass the following subject matter areas, all of which fall within your recognized expertise:

(a) Genomic classification methods for cancer prognosis, with a particular focus on prostate cancer;

(b) Machine-learning classifier architectures, including but not limited to random-forest classifiers, gradient-boosted decision tree classifiers, and other ensemble learning methods used in clinical genomics;

(c) Gene-expression profiling methodologies from formalin-fixed paraffin-embedded (FFPE) tissue samples, including RNA extraction, amplification, and quantification techniques;

(d) Reference-gene normalization techniques used in connection with gene-expression profiling assays; and

(e) Combined genomic and clinical variable prognostic models, including the integration of molecular biomarker data with pathological grading systems (e.g., Gleason grade group) and serum biomarkers (e.g., pre-operative PSA).

3.2 Specific Tasks

We anticipate that your work in this engagement will include, but not necessarily be limited to, the following tasks:

(a) Patent Review. Review and analyze the three Patents-in-Suit — the '271 Patent, the '893 Patent, and the '647 Patent — including their respective claims, specifications, and prosecution histories before the United States Patent and Trademark Office.

(b) Accused Product Analysis. Review and analyze Helios's ProstaSignal™ Genomic Classifier in detail, including its 24-gene panel composition, algorithm architecture, feature selection methodology, training data sets, model validation protocols, and clinical output (including the ProstaScore and risk classification system).

(c) Infringement Opinions. Provide opinions as to whether the ProstaSignal™ test literally infringes and/or infringes under the doctrine of equivalents the asserted claims of each of the three Patents-in-Suit. In particular, you will be asked to address:

(i) Whether Helios's gradient-boosted decision tree classifier falls within the scope of the claim limitation "trained machine-learning classifier" as recited in Claim 1 of the '271 Patent;

(ii) Whether Helios's gradient-boosted decision tree classifier is equivalent to a "random-forest classifier" as recited in Claim 1 of the '893 Patent under the doctrine of equivalents, applying the function-way-result test and the insubstantial differences test; and

(iii) Whether the ProstaSignal™ test satisfies the combined genomic and clinical variable limitations of the '647 Patent.

(d) Claim Construction. Assist counsel in proposing constructions for disputed claim terms anticipated to be at issue in the Markman proceeding, including the terms "trained machine-learning classifier," "random-forest classifier," "panel of at least 22 genes selected from a predefined gene set," "risk category," and "composite risk metric."

(e) Invalidity Analysis. Review and respond to Helios's invalidity contentions under 35 U.S.C. §§ 101, 102, and 103. This will include analysis of the prior art references identified by Helios in its invalidity contentions, including:

(i) Nakamura et al., U.S. Patent No. 9,617,340;

(ii) Gagnon, International Publication No. WO 2018/065413;

(iii) Thornberry et al., "Ensemble Machine Learning Approaches for Genomic Cancer Classification," Journal of Computational Oncology, Vol. 14, No. 3, pp. 287–301 (March 2015); and

(iv) Klein et al., "A Genomic Classifier Improves Prostate Cancer Risk Stratification After Radical Prostatectomy," European Urology, Vol. 66, No. 1, pp. 45–52 (2014).

(f) Validity Opinions. Provide opinions as to whether the asserted claims of the Patents-in-Suit are novel and non-obvious over the cited prior art, individually and in combination, and whether the asserted claims satisfy the patent-eligibility requirements of 35 U.S.C. § 101.

(g) discovery Material Review. Review discovery materials produced by Helios in this litigation (subject to the terms of the Protective Order, as described in Section 6 below), including technical documents regarding ProstaSignal™ development, algorithm training data, feature selection processes, internal testing and validation studies, and clinical validation data.

(h) Markman Hearing Preparation. Assist counsel in preparing for the Markman hearing currently scheduled for September 18, 2026, including the preparation of claim construction briefing materials, tutorials, and demonstrative exhibits. You may be called upon to provide testimony at the Markman hearing.

3.3 Consulting vs. Testifying Role

You are initially being retained in a consulting capacity. In this role, your communications with C&H and your work product will be protected from disclosure under the attorney work-product doctrine and, to the extent applicable, the attorney-client privilege.

The Firm reserves the right, with your concurrence, to designate you as a testifying expert witness on behalf of GenomeDx. If you are so designated, you should be aware that your obligations will expand to include the following:

(a) Preparation and execution of a written expert report that fully complies with the requirements of Federal Rule of Civil Procedure 26(a)(2)(B), including a complete statement of all opinions to be expressed and the basis and reasons therefor, the facts or data considered in forming the opinions, any exhibits to be used to summarize or support the opinions, a statement of your qualifications and a list of all publications authored in the preceding ten years, a list of all cases in which you have testified as an expert at trial or by deposition within the preceding four years, and a statement of the compensation to be paid for the study and testimony in the case;

(b) Testimony at deposition, which will be conducted by counsel for Helios;

(d) Testimony at trial, currently scheduled for February 2027.

We will discuss the decision regarding your designation as a testifying expert with you in advance, and we will ensure that you have adequate time and resources to prepare any required report and testimony.

4. Anticipated Deliverables and Timeline

Based on the Court's current Scheduling Order, we anticipate the following phases of work and associated deliverables:

4.1 Consulting Phase (February 2026 – April 2026)

During the initial consulting phase, we expect that you will undertake the following:

(a) Review the Patents-in-Suit, their respective prosecution histories, and GenomeDx's infringement claim charts;

(b) Review available fact-discovery materials produced by Helios, including technical documentation, source code (if produced), and internal communications relating to the development, testing, and commercialization of ProstaSignal™;

(c) Provide preliminary oral or written analysis of the strengths and weaknesses of GenomeDx's infringement theories and validity positions, to assist counsel in case strategy and discovery planning; and

(d) Assist counsel in preparing claim construction briefing and related materials in advance of the Markman hearing.

We anticipate scheduling regular meetings and calls during this phase to discuss your preliminary analyses and to coordinate the scope of additional materials and discovery you may require.

4.2 Expert Report Phase (April 2026 – May 15, 2026)

Pursuant to the Scheduling Order, the deadline for service of opening expert reports is May 15, 2026. If you are designated as a testifying expert, you will be expected to prepare and execute a written expert report covering both infringement and validity opinions, in full compliance with Federal Rule of Civil Procedure 26(a)(2)(B). The report should set forth all opinions to be expressed, the bases and reasons for each opinion, all facts and data considered in forming the opinions, all exhibits to be used to summarize or support the opinions, your qualifications (including a list of all publications authored in the preceding ten years), a list of all cases in which you have testified as an expert at trial or by deposition within the preceding four years, and a statement of the compensation to be paid for the study and testimony in the case.

We will work closely with you during this phase to ensure the report is thorough, well-supported, and timely.

4.3 Rebuttal Phase (May 2026 – July 10, 2026)

We anticipate that Helios will serve its own expert reports on or about May 15, 2026. You will be asked to review the opposing expert's report(s) and to prepare a rebuttal expert report, if appropriate, addressing the opinions and analyses set forth by Helios's expert(s). The deadline for rebuttal expert reports is July 10, 2026.

4.4 Markman Hearing (September 18, 2026)

You may be called upon to provide live testimony and/or to assist counsel at the Markman hearing on claim construction, which is currently scheduled for September 18, 2026. We will prepare you in advance of the hearing through one or more preparation sessions.

4.5 Trial (February 2027)

If the case proceeds to trial, you will be expected to testify as a live witness at trial, which is currently scheduled for February 2027. We will conduct trial preparation sessions with you in advance of trial to review your testimony, prepare demonstrative exhibits, and address anticipated cross-examination topics.

All dates are subject to adjustment by the Court. We will keep you informed of any changes to the schedule as they arise.

5. Compensation

5.1 Hourly Rate

Your hourly rate for all professional services rendered in connection with this engagement shall be $\_\_\_\_\_\_ per hour (to be negotiated and inserted upon your acceptance). This rate shall apply uniformly to all categories of work, including but not limited to: document review, technical analysis, report preparation, meetings and conferences with counsel (whether in person, by telephone, or by videoconference), deposition testimony, hearing testimony, trial testimony, and travel time.

5.2 Invoicing and Payment

You shall submit monthly invoices to Calderwood & Harkness LLP detailing the hours worked, a description of the tasks performed during each time entry (at a level of detail sufficient for billing review purposes), and any expenses incurred during the billing period. Payment will be made within thirty (30) days of C&H's receipt of each invoice.

Invoices should be directed to:

Alan Ngo, Billing Partner Calderwood & Harkness LLP 555 Mission Street, Suite 3100 San Francisco, California 94105

Email: angu@calderwoodharkness.com

5.3 Expenses. Reasonable out-of-pocket expenses incurred in connection with this engagement will be reimbursed by C&H, including but not limited to travel expenses, lodging, meals, ground transportation, and document reproduction costs. Air travel shall be at coach or economy class unless otherwise approved in advance in writing by C&H. Any single expense item exceeding Five Hundred Dollars ($500.00) requires prior written approval from C&H before the expense is incurred.

5.4 No Contingent Fee

Your compensation is in no way contingent on the outcome of this litigation or on the substance of any opinions you render. Your compensation is based solely on the time you devote to this engagement and the reasonable expenses you incur in connection therewith. Your opinions must be based solely on your independent professional judgment and expertise, and must not be influenced by considerations of compensation or the interests of any party to the litigation. This provision is fundamental to the integrity of your role as an expert and to the admissibility of your testimony under Federal Rule of Evidence 702 and Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993).

6. Confidentiality Obligations

6.1 Stipulated Protective Order

This matter is governed by a Stipulated Protective Order entered by the Court on December 18, 2025 (the "Protective Order"). A copy of the Protective Order is enclosed with this letter as Enclosure 1.

The Protective Order establishes two tiers of confidentiality designations:

(a) "Confidential" — materials and information containing non-public business, technical, or financial information that the producing party considers to be confidential; and

(b) "Highly Confidential — Attorneys' Eyes Only" — materials and information of the most sensitive nature, including trade secrets, proprietary source code, and competitively sensitive business information, access to which is limited to outside counsel, in-house counsel (subject to certain restrictions), and retained experts.

In your capacity as a retained expert, you will receive and may review materials designated under both tiers of confidentiality, subject to the terms and conditions of the Protective Order. Prior to receiving any materials designated as "Confidential" or "Highly Confidential — Attorneys' Eyes Only," you must review the Protective Order in its entirety and execute the "Acknowledgment and Agreement to Be Bound" form attached to the Protective Order as Exhibit A. A copy of the Acknowledgment and Agreement to Be Bound form is enclosed with this letter as Enclosure 2. Please execute and return the form to us along with the signed copy of this Engagement Letter.

6.2 General Confidentiality

All information provided to you by C&H or GenomeDx in connection with this engagement, including but not limited to factual information, legal theories, case strategy, attorney work product, and privileged communications, is confidential and is protected by the attorney-client privilege and/or the work-product doctrine. Similarly, all work product, analyses, draft reports, notes, and opinions generated by you in connection with this engagement are confidential and, to the extent they reflect or incorporate attorney work product or privileged communications, are protected by those doctrines.

You shall not disclose any such information to any third party — including but not limited to academic colleagues, research collaborators, family members, or the press — without the prior written consent of C&H. Any inadvertent disclosure must be reported to C&H immediately.

All materials received in connection with this engagement must be stored securely, whether in physical or electronic form, and must be protected from unauthorized access. Upon conclusion of the engagement (whether by completion or termination), all materials containing confidential information from the litigation shall be returned to C&H or destroyed in accordance with the terms of the Protective Order and as directed by C&H.

6.3 Use Limitation

Materials designated as "Confidential" or "Highly Confidential — Attorneys' Eyes Only" under the Protective Order, and all other confidential information received in connection with this engagement, may be used solely for the purposes of this litigation and for no other purpose whatsoever. Without limiting the generality of the foregoing, such materials may not be used for any academic research, publication, presentation, grant application, or other professional or personal purpose, nor may they be shared with any student, postdoctoral researcher, or other member of your laboratory or research group.

7. Conflict Check and Independence

By signing this Engagement Letter, you represent and warrant the following:

(a) You have no current financial interest in, employment by, consulting arrangement with, or other material relationship with Helios Precision Diagnostics, Inc., Corinth Ventures Fund III, LP (an investor in Helios), Ridgecrest Durneval LLP (counsel for Helios), or any other party adverse to GenomeDx in this matter;

(b) You have not previously been retained by, or provided expert opinions or consulting services for, Helios or its counsel in any matter;

(c) You are not aware of any other circumstance that would create a conflict of interest or that could reasonably be expected to impair your ability to provide independent and objective opinions in this matter; and

(d) Your opinions in this matter will be formed independently, based on your expertise in computational oncology, genomic classification methods, and machine learning as applied to cancer diagnostics, and will not be influenced by the interests of GenomeDx, C&H, or any other party.

You agree to promptly notify C&H if, at any time during the course of this engagement, any actual or potential conflict of interest arises, including but not limited to any new financial interest in, consulting arrangement with, or professional relationship with Helios, Ridgecrest Durneval LLP, or any entity affiliated with Helios.

8. Document Retention

You shall maintain copies of all documents reviewed, notes taken, drafts prepared, data analyzed, calculations performed, and communications with counsel in connection with this engagement. These materials should be maintained in an organized and retrievable manner, as they may be subject to discovery obligations in connection with your role as a testifying expert.

Under Federal Rule of Civil Procedure 26(a)(2)(B), a testifying expert's report must disclose, among other things, the "facts or data considered by the witness in forming" the expert's opinions. However, draft expert reports and communications between counsel and a testifying expert are generally protected from disclosure under the protections set forth in Federal Rule of Civil Procedure 26(b)(4)(B) (protecting draft reports) and 26(b)(4)(C) (protecting attorney-expert communications, subject to limited exceptions for communications relating to compensation, facts or data provided by counsel that the expert considered, and assumptions provided by counsel that the expert relied upon). We will provide further guidance on document retention practices and the scope of these protections as the engagement progresses.

At the conclusion of the engagement, all materials containing confidential information from the litigation — including documents designated under the Protective Order, notes reflecting confidential information, and work product incorporating such information — shall be returned to C&H or destroyed in accordance with the Protective Order. We will coordinate the return or destruction process with you at the appropriate time.

9. Termination

Either party may terminate this engagement upon thirty (30) days' prior written notice to the other party. Written notice of termination should be directed as follows: if by you, to Catherine Bloom, Calderwood & Harkness LLP, 555 Mission Street, Suite 3100, San Francisco, California 94105; if by C&H, to you at your address set forth above, or at such other address as you may provide in writing.

Upon termination, you shall be entitled to compensation for all services rendered and expenses incurred through the effective date of termination, in accordance with the terms of Section 5 above. You shall submit a final invoice within thirty (30) days of the effective date of termination.

Your confidentiality obligations under Section 6 of this Engagement Letter, including your obligations under the Protective Order and the Acknowledgment and Agreement to Be Bound, shall survive termination of this engagement and remain in full force and effect indefinitely or until such time as the Protective Order is modified or vacated by the Court.

10. Relationship of the Parties

You are being retained as an independent contractor. Nothing in this Engagement Letter shall be construed to create a partnership, joint venture, agency, or employer-employee relationship between you and Calderwood & Harkness LLP or between you and Genome Dx Therapeutics Inc. You shall have no authority to bind C&H or GenomeDx to any obligation or commitment, and you shall not represent yourself as an employee or agent of either C&H or GenomeDx. You are solely responsible for the payment of all taxes, insurance, and other obligations arising from your status as an independent contractor.

11. Governing Law

This Engagement Letter shall be governed by and construed in accordance with the laws of the State of California, without regard to its conflicts of law principles. Any dispute arising out of or relating to this Engagement Letter shall be subject to the exclusive jurisdiction of the state and federal courts located in San Francisco County, California.

12. Acceptance

If the foregoing terms are acceptable to you, please indicate your acceptance by signing and dating this Engagement Letter in the space provided below and returning a signed copy to us, together with the executed Acknowledgment and Agreement to Be Bound (Enclosure 2), at your earliest convenience. A duplicate original of this letter is enclosed for your records.

We are enthusiastic about the prospect of working with you on this important matter and are confident that your expertise will be invaluable to GenomeDx's case. Please do not hesitate to contact me directly at (415) 762-4112 or at cbloom@calderwoodharkness.com if you have any questions regarding the terms of this Engagement Letter or the scope of the engagement.

Sincerely,

CALDERWOOD & HARKNESS LLP

By: ________

Catherine Bloom Partner, intellectual Property 555 Mission Street, Suite 3100 San Francisco, California 94105 Telephone: (415) 762-4112

Email: cbloom@calderwoodharkness.com

ACCEPTED AND AGREED

________________________________________

Dr. Franklin Ogawa, PhD Professor of Computational Oncology Stanford University

Date: ________

________________________________________

Catherine Bloom Partner, Calderwood & Harkness LLP

Date: ________

ENCLOSURES

Enclosure 1: Stipulated Protective Order (entered December 18, 2025)

Enclosure 2: Acknowledgment and Agreement to Be Bound (Protective Order, Exhibit A)

Enclosure 3: Copies of U.S. Patent No. 10,438,271; U.S. Patent No. 11,204,893; and U.S. Patent No. 11,891,647

Enclosure 4: Complaint for Patent Infringement, Genome Dx Therapeutics Inc. v. Helios Precision Diagnostics, Inc., Case No. 3:25-cv-01847-JWL (filed March 28, 2025)

Enclosure 5: Scheduling Order (entered June 18, 2025)

cc: Victoria Sung, General Counsel, Genome Dx Therapeutics Inc. cc: Alan Ngo, Calderwood & Harkness LLP cc: Peter Vassiliev, Calderwood & Harkness LLP

PRIVILEGED & CONFIDENTIAL / ATTORNEY WORK PRODUCT
CALDERWOOD & HARKNESS LLP 555 Mission Street, Suite 3100 San Francisco, California 94105 Telephone: (415) 762-4000 Facsimile: (415) 762-4001 www.calderwoodharkness.com
February \\\_, 2026
Dr. Franklin Ogawa, PhD Professor of Computational Oncology Stanford University Department of Biomedical Data Science 1265 Welch Road, MSOB X-215 Stanford, California 94305
Re: Retention as Expert Consultant and Testifying Expert — *Genome Dx Therapeutics Inc. v. Helios Precision Diagnostics, Inc.*, Case No. 3:25-cv-01847-JWL, United States District Court for the Northern District of California
Dear Dr. Ogawa:
1. Purpose and Engagement Overview
Calderwood & Harkness LLP ("C&H" or "the Firm") represents Genome Dx Therapeutics Inc. ("GenomeDx" or "Client") as plaintiff in the above-captioned patent infringement action pending before the United States District Court for the Northern District of California against Helios Precision Diagnostics, Inc. ("Helios"). We write to confirm the terms under which GenomeDx seeks to retain you as an expert consultant and, if appropriate, as a testifying expert witness on behalf of GenomeDx in this matter.
The litigation arises out of Helios's manufacture, use, sale, offer for sale, and importation of its ProstaSignal™ Genomic Classifier (the "Accused Product"), a 24-gene expression-based prognostic test designed for use in prostate cancer prognosis following radical prostatectomy. The ProstaSignal™ test was commercially launched by Helios on October 7, 2024, and has since been marketed and sold throughout the United States.
GenomeDx has asserted infringement of three United States patents covering its proprietary genomic-classifier methods for prostate cancer prognosis:
•  United States Patent No. 10,438,271 (the "'271 Patent"), entitled "Methods and Systems for Genomic Classification of Cancer Prognosis Using Trained Machine-Learning Classifiers";
•  United States Patent No. 11,204,893 (the "'893 Patent"), entitled "Random-Forest Classifier Systems for Prostate Cancer Prognostic Gene-Expression Profiling"; and
•  United States Patent No. 11,891,647 (the "'647 Patent"), entitled "Integrated Genomic and Clinical Variable Models for Cancer Risk Stratification."
These patents are collectively referred to herein as the "Patents-in-Suit."
Your engagement is subject to the terms and conditions set forth in this letter (the "Engagement Letter"). We believe your extensive expertise in computational oncology, machine-learning methodologies as applied to cancer diagnostics, and genomic classification systems makes you uniquely well-suited to provide expert analysis and, if needed, testimony in this matter. We look forward to working with you and appreciate your willingness to consider this engagement.
2. Background of the Litigation
To provide context for the scope of work contemplated by this Engagement Letter, we summarize below the relevant procedural and substantive background of the litigation.
2.1 Procedural History. GenomeDx filed its Complaint for Patent Infringement on March 28, 2025, in the United States District Court for the Northern District of California. The case has been assigned to the Honorable Jessica W. Langston, United States District Judge, with the Honorable David R. Cabrera, United States Magistrate Judge, assigned for the resolution of discovery disputes. The case bears Case No. 3:25-cv-01847-JWL. Helios is represented by Ridgecrest Durneval LLP, with lead partner Marcus Pellegrini serving as lead trial counsel for the defense.
2.2 Infringement Theories. GenomeDx alleges that Helios's ProstaSignal™ Genomic Classifier infringes the asserted claims of all three Patents-in-Suit. The principal infringement theories may be summarized as follows:
(a) Gene Panel Overlap. The ProstaSignal™ test employs a 24-gene expression panel. Of those 24 genes, 19 overlap directly with the genes comprising GenomeDx's patented gene set. This degree of overlap implicates the gene-selection limitations recited in the asserted claims of the '271 Patent and the '893 Patent, including in particular the limitation requiring "a panel of at least 22 genes selected from a predefined gene set."
(b) Machine-Learning Classifier Architecture. The ProstaSignal™ test utilizes a gradient-boosted decision tree classifier to generate its prognostic output. Claim 1 of the '271 Patent recites a "trained machine-learning classifier," while Claim 1 of the '893 Patent more specifically recites a "random-forest classifier." GenomeDx contends that Helios's gradient-boosted decision tree classifier falls within the scope of "trained machine-learning classifier" as recited in the '271 Patent and, in the alternative, that it infringes the '893 Patent under the doctrine of equivalents.
(c) Prognostic Score and Risk Classification. The ProstaSignal™ test generates a numerical output — the "ProstaScore" — on a scale of 0 to 100 and classifies patients into three risk categories: Low, Intermediate, and High. This output structure maps onto the claim limitations of the Patents-in-Suit that recite the generation of a "risk category" and a "composite risk metric."
(d) Combined Genomic and Clinical Variable Model. The ProstaSignal™ test combines its genomic score with Gleason grade group and pre-operative prostate-specific antigen (PSA) levels, thereby implicating the '647 Patent's limitations directed to combined biomarker and clinical variable prognostic models.
2.3 Helios's Defenses and Counterclaims. Helios has asserted counterclaims of invalidity under 35 U.S.C. §§ 101, 102, and 103, non-infringement, and unenforceability. Helios's Section 101 challenge contends that the asserted claims are directed to patent-ineligible abstract ideas or natural phenomena. On January 13, 2026, the Court denied Helios's motion to dismiss Counts II and III (directed to the '893 Patent and the '647 Patent, respectively) under 35 U.S.C. § 101, finding that GenomeDx had plausibly alleged that the asserted claims recite patent-eligible subject matter under the Alice/Mayo framework. The Court's order did not address the merits of Helios's remaining invalidity defenses under Sections 102 and 103, which remain to be resolved on a full evidentiary record.
2.4 Current Status of discovery. The parties are currently engaged in active fact discovery. Pursuant to the Scheduling Order entered on June 18, 2025, fact discovery is set to close on March 6, 2026. Expert discovery will follow, with opening expert reports due on May 15, 2026, and rebuttal expert reports due on July 10, 2026. A Markman hearing on claim construction has been set for September 18, 2026. Trial is currently scheduled for February 2027.
3. Scope of Engagement
3.1 Subject Matter Areas
Your engagement will encompass the following subject matter areas, all of which fall within your recognized expertise:
(a) Genomic classification methods for cancer prognosis, with a particular focus on prostate cancer;
(b) Machine-learning classifier architectures, including but not limited to random-forest classifiers, gradient-boosted decision tree classifiers, and other ensemble learning methods used in clinical genomics;
(c) Gene-expression profiling methodologies from formalin-fixed paraffin-embedded (FFPE) tissue samples, including RNA extraction, amplification, and quantification techniques;
(d) Reference-gene normalization techniques used in connection with gene-expression profiling assays; and
(e) Combined genomic and clinical variable prognostic models, including the integration of molecular biomarker data with pathological grading systems (e.g., Gleason grade group) and serum biomarkers (e.g., pre-operative PSA).
3.2 Specific Tasks
We anticipate that your work in this engagement will include, but not necessarily be limited to, the following tasks:
(a) Patent Review. Review and analyze the three Patents-in-Suit — the '271 Patent, the '893 Patent, and the '647 Patent — including their respective claims, specifications, and prosecution histories before the United States Patent and Trademark Office.
(b) Accused Product Analysis. Review and analyze Helios's ProstaSignal™ Genomic Classifier in detail, including its 24-gene panel composition, algorithm architecture, feature selection methodology, training data sets, model validation protocols, and clinical output (including the ProstaScore and risk classification system).
(c) Infringement Opinions. Provide opinions as to whether the ProstaSignal™ test literally infringes and/or infringes under the doctrine of equivalents the asserted claims of each of the three Patents-in-Suit. In particular, you will be asked to address:
(i) Whether Helios's gradient-boosted decision tree classifier falls within the scope of the claim limitation "trained machine-learning classifier" as recited in Claim 1 of the '271 Patent;
(ii) Whether Helios's gradient-boosted decision tree classifier is equivalent to a "random-forest classifier" as recited in Claim 1 of the '893 Patent under the doctrine of equivalents, applying the function-way-result test and the insubstantial differences test; and
(iii) Whether the ProstaSignal™ test satisfies the combined genomic and clinical variable limitations of the '647 Patent.
(d) Claim Construction. Assist counsel in proposing constructions for disputed claim terms anticipated to be at issue in the Markman proceeding, including the terms "trained machine-learning classifier," "random-forest classifier," "panel of at least 22 genes selected from a predefined gene set," "risk category," and "composite risk metric."
(e) Invalidity Analysis. Review and respond to Helios's invalidity contentions under 35 U.S.C. §§ 101, 102, and 103. This will include analysis of the prior art references identified by Helios in its invalidity contentions, including:
(i) Nakamura et al., U.S. Patent No. 9,617,340;
(ii) Gagnon, International Publication No. WO 2018/065413;
(iii) Thornberry et al., "Ensemble Machine Learning Approaches for Genomic Cancer Classification," Journal of Computational Oncology, Vol. 14, No. 3, pp. 287–301 (March 2015); and
(iv) Klein et al., "A Genomic Classifier Improves Prostate Cancer Risk Stratification After Radical Prostatectomy," European Urology, Vol. 66, No. 1, pp. 45–52 (2014).
(f) Validity Opinions. Provide opinions as to whether the asserted claims of the Patents-in-Suit are novel and non-obvious over the cited prior art, individually and in combination, and whether the asserted claims satisfy the patent-eligibility requirements of 35 U.S.C. § 101.
(g) discovery Material Review. Review discovery materials produced by Helios in this litigation (subject to the terms of the Protective Order, as described in Section 6 below), including technical documents regarding ProstaSignal™ development, algorithm training data, feature selection processes, internal testing and validation studies, and clinical validation data.
(h) Markman Hearing Preparation. Assist counsel in preparing for the Markman hearing currently scheduled for September 18, 2026, including the preparation of claim construction briefing materials, tutorials, and demonstrative exhibits. You may be called upon to provide testimony at the Markman hearing.
3.3 Consulting vs. Testifying Role
You are initially being retained in a consulting capacity. In this role, your communications with C&H and your work product will be protected from disclosure under the attorney work-product doctrine and, to the extent applicable, the attorney-client privilege.
The Firm reserves the right, with your concurrence, to designate you as a testifying expert witness on behalf of GenomeDx. If you are so designated, you should be aware that your obligations will expand to include the following:
(a) Preparation and execution of a written expert report that fully complies with the requirements of Federal Rule of Civil Procedure 26(a)(2)(B), including a complete statement of all opinions to be expressed and the basis and reasons therefor, the facts or data considered in forming the opinions, any exhibits to be used to summarize or support the opinions, a statement of your qualifications and a list of all publications authored in the preceding ten years, a list of all cases in which you have testified as an expert at trial or by deposition within the preceding four years, and a statement of the compensation to be paid for the study and testimony in the case;
(b) Testimony at deposition, which will be conducted by counsel for Helios;
(c) Testimony at the Markman hearing, if requested by counsel; and
(d) Testimony at trial, currently scheduled for February 2027.
We will discuss the decision regarding your designation as a testifying expert with you in advance, and we will ensure that you have adequate time and resources to prepare any required report and testimony.
4. Anticipated Deliverables and Timeline
Based on the Court's current Scheduling Order, we anticipate the following phases of work and associated deliverables:
4.1 Consulting Phase (February 2026 – April 2026)
During the initial consulting phase, we expect that you will undertake the following:
(a) Review the Patents-in-Suit, their respective prosecution histories, and GenomeDx's infringement claim charts;
(b) Review available fact-discovery materials produced by Helios, including technical documentation, source code (if produced), and internal communications relating to the development, testing, and commercialization of ProstaSignal™;
(c) Provide preliminary oral or written analysis of the strengths and weaknesses of GenomeDx's infringement theories and validity positions, to assist counsel in case strategy and discovery planning; and
(d) Assist counsel in preparing claim construction briefing and related materials in advance of the Markman hearing.
We anticipate scheduling regular meetings and calls during this phase to discuss your preliminary analyses and to coordinate the scope of additional materials and discovery you may require.
4.2 Expert Report Phase (April 2026 – May 15, 2026)
Pursuant to the Scheduling Order, the deadline for service of opening expert reports is May 15, 2026. If you are designated as a testifying expert, you will be expected to prepare and execute a written expert report covering both infringement and validity opinions, in full compliance with Federal Rule of Civil Procedure 26(a)(2)(B). The report should set forth all opinions to be expressed, the bases and reasons for each opinion, all facts and data considered in forming the opinions, all exhibits to be used to summarize or support the opinions, your qualifications (including a list of all publications authored in the preceding ten years), a list of all cases in which you have testified as an expert at trial or by deposition within the preceding four years, and a statement of the compensation to be paid for the study and testimony in the case.
We will work closely with you during this phase to ensure the report is thorough, well-supported, and timely.
4.3 Rebuttal Phase (May 2026 – July 10, 2026)
We anticipate that Helios will serve its own expert reports on or about May 15, 2026. You will be asked to review the opposing expert's report(s) and to prepare a rebuttal expert report, if appropriate, addressing the opinions and analyses set forth by Helios's expert(s). The deadline for rebuttal expert reports is July 10, 2026.
4.4 Markman Hearing (September 18, 2026)
You may be called upon to provide live testimony and/or to assist counsel at the Markman hearing on claim construction, which is currently scheduled for September 18, 2026. We will prepare you in advance of the hearing through one or more preparation sessions.
4.5 Trial (February 2027)
If the case proceeds to trial, you will be expected to testify as a live witness at trial, which is currently scheduled for February 2027. We will conduct trial preparation sessions with you in advance of trial to review your testimony, prepare demonstrative exhibits, and address anticipated cross-examination topics.
All dates are subject to adjustment by the Court. We will keep you informed of any changes to the schedule as they arise.
5. Compensation
5.1 Hourly Rate
Your hourly rate for all professional services rendered in connection with this engagement shall be $\_\_\_\_\_\_ per hour (to be negotiated and inserted upon your acceptance). This rate shall apply uniformly to all categories of work, including but not limited to: document review, technical analysis, report preparation, meetings and conferences with counsel (whether in person, by telephone, or by videoconference), deposition testimony, hearing testimony, trial testimony, and travel time.
5.2 Invoicing and Payment
You shall submit monthly invoices to Calderwood & Harkness LLP detailing the hours worked, a description of the tasks performed during each time entry (at a level of detail sufficient for billing review purposes), and any expenses incurred during the billing period. Payment will be made within thirty (30) days of C&H's receipt of each invoice.
Invoices should be directed to:
Alan Ngo, Billing Partner Calderwood & Harkness LLP 555 Mission Street, Suite 3100 San Francisco, California 94105
Email: angu@calderwoodharkness.com
5.3 Expenses.  Reasonable out-of-pocket expenses incurred in connection with this engagement will be reimbursed by C&H, including but not limited to travel expenses, lodging, meals, ground transportation, and document reproduction costs. Air travel shall be at coach or economy class unless otherwise approved in advance in writing by C&H. Any single expense item exceeding Five Hundred Dollars ($500.00) requires prior written approval from C&H before the expense is incurred.
5.4 No Contingent Fee
Your compensation is in no way contingent on the outcome of this litigation or on the substance of any opinions you render. Your compensation is based solely on the time you devote to this engagement and the reasonable expenses you incur in connection therewith. Your opinions must be based solely on your independent professional judgment and expertise, and must not be influenced by considerations of compensation or the interests of any party to the litigation. This provision is fundamental to the integrity of your role as an expert and to the admissibility of your testimony under Federal Rule of Evidence 702 and Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993).
6. Confidentiality Obligations
6.1 Stipulated Protective Order
This matter is governed by a Stipulated Protective Order entered by the Court on December 18, 2025 (the "Protective Order"). A copy of the Protective Order is enclosed with this letter as Enclosure 1.
The Protective Order establishes two tiers of confidentiality designations:
(a) "Confidential" — materials and information containing non-public business, technical, or financial information that the producing party considers to be confidential; and
(b) "Highly Confidential — Attorneys' Eyes Only" — materials and information of the most sensitive nature, including trade secrets, proprietary source code, and competitively sensitive business information, access to which is limited to outside counsel, in-house counsel (subject to certain restrictions), and retained experts.
In your capacity as a retained expert, you will receive and may review materials designated under both tiers of confidentiality, subject to the terms and conditions of the Protective Order. Prior to receiving any materials designated as "Confidential" or "Highly Confidential — Attorneys' Eyes Only," you must review the Protective Order in its entirety and execute the "Acknowledgment and Agreement to Be Bound" form attached to the Protective Order as Exhibit A. A copy of the Acknowledgment and Agreement to Be Bound form is enclosed with this letter as Enclosure 2. Please execute and return the form to us along with the signed copy of this Engagement Letter.
6.2 General Confidentiality
All information provided to you by C&H or GenomeDx in connection with this engagement, including but not limited to factual information, legal theories, case strategy, attorney work product, and privileged communications, is confidential and is protected by the attorney-client privilege and/or the work-product doctrine. Similarly, all work product, analyses, draft reports, notes, and opinions generated by you in connection with this engagement are confidential and, to the extent they reflect or incorporate attorney work product or privileged communications, are protected by those doctrines.
You shall not disclose any such information to any third party — including but not limited to academic colleagues, research collaborators, family members, or the press — without the prior written consent of C&H. Any inadvertent disclosure must be reported to C&H immediately.
All materials received in connection with this engagement must be stored securely, whether in physical or electronic form, and must be protected from unauthorized access. Upon conclusion of the engagement (whether by completion or termination), all materials containing confidential information from the litigation shall be returned to C&H or destroyed in accordance with the terms of the Protective Order and as directed by C&H.
6.3 Use Limitation
Materials designated as "Confidential" or "Highly Confidential — Attorneys' Eyes Only" under the Protective Order, and all other confidential information received in connection with this engagement, may be used solely for the purposes of this litigation and for no other purpose whatsoever. Without limiting the generality of the foregoing, such materials may not be used for any academic research, publication, presentation, grant application, or other professional or personal purpose, nor may they be shared with any student, postdoctoral researcher, or other member of your laboratory or research group.
7. Conflict Check and Independence
By signing this Engagement Letter, you represent and warrant the following:
(a) You have no current financial interest in, employment by, consulting arrangement with, or other material relationship with Helios Precision Diagnostics, Inc., Corinth Ventures Fund III, LP (an investor in Helios), Ridgecrest Durneval LLP (counsel for Helios), or any other party adverse to GenomeDx in this matter;
(b) You have not previously been retained by, or provided expert opinions or consulting services for, Helios or its counsel in any matter;
(c) You are not aware of any other circumstance that would create a conflict of interest or that could reasonably be expected to impair your ability to provide independent and objective opinions in this matter; and
(d) Your opinions in this matter will be formed independently, based on your expertise in computational oncology, genomic classification methods, and machine learning as applied to cancer diagnostics, and will not be influenced by the interests of GenomeDx, C&H, or any other party.
You agree to promptly notify C&H if, at any time during the course of this engagement, any actual or potential conflict of interest arises, including but not limited to any new financial interest in, consulting arrangement with, or professional relationship with Helios, Ridgecrest Durneval LLP, or any entity affiliated with Helios.
8. Document Retention
You shall maintain copies of all documents reviewed, notes taken, drafts prepared, data analyzed, calculations performed, and communications with counsel in connection with this engagement. These materials should be maintained in an organized and retrievable manner, as they may be subject to discovery obligations in connection with your role as a testifying expert.
Under Federal Rule of Civil Procedure 26(a)(2)(B), a testifying expert's report must disclose, among other things, the "facts or data considered by the witness in forming" the expert's opinions. However, draft expert reports and communications between counsel and a testifying expert are generally protected from disclosure under the protections set forth in Federal Rule of Civil Procedure 26(b)(4)(B) (protecting draft reports) and 26(b)(4)(C) (protecting attorney-expert communications, subject to limited exceptions for communications relating to compensation, facts or data provided by counsel that the expert considered, and assumptions provided by counsel that the expert relied upon). We will provide further guidance on document retention practices and the scope of these protections as the engagement progresses.
At the conclusion of the engagement, all materials containing confidential information from the litigation — including documents designated under the Protective Order, notes reflecting confidential information, and work product incorporating such information — shall be returned to C&H or destroyed in accordance with the Protective Order. We will coordinate the return or destruction process with you at the appropriate time.
9. Termination
Either party may terminate this engagement upon thirty (30) days' prior written notice to the other party. Written notice of termination should be directed as follows: if by you, to Catherine Bloom, Calderwood & Harkness LLP, 555 Mission Street, Suite 3100, San Francisco, California 94105; if by C&H, to you at your address set forth above, or at such other address as you may provide in writing.
Upon termination, you shall be entitled to compensation for all services rendered and expenses incurred through the effective date of termination, in accordance with the terms of Section 5 above. You shall submit a final invoice within thirty (30) days of the effective date of termination.
Your confidentiality obligations under Section 6 of this Engagement Letter, including your obligations under the Protective Order and the Acknowledgment and Agreement to Be Bound, shall survive termination of this engagement and remain in full force and effect indefinitely or until such time as the Protective Order is modified or vacated by the Court.
10. Relationship of the Parties
You are being retained as an independent contractor. Nothing in this Engagement Letter shall be construed to create a partnership, joint venture, agency, or employer-employee relationship between you and Calderwood & Harkness LLP or between you and Genome Dx Therapeutics Inc. You shall have no authority to bind C&H or GenomeDx to any obligation or commitment, and you shall not represent yourself as an employee or agent of either C&H or GenomeDx. You are solely responsible for the payment of all taxes, insurance, and other obligations arising from your status as an independent contractor.
11. Governing Law
This Engagement Letter shall be governed by and construed in accordance with the laws of the State of California, without regard to its conflicts of law principles. Any dispute arising out of or relating to this Engagement Letter shall be subject to the exclusive jurisdiction of the state and federal courts located in San Francisco County, California.
12. Acceptance
If the foregoing terms are acceptable to you, please indicate your acceptance by signing and dating this Engagement Letter in the space provided below and returning a signed copy to us, together with the executed Acknowledgment and Agreement to Be Bound (Enclosure 2), at your earliest convenience. A duplicate original of this letter is enclosed for your records.
We are enthusiastic about the prospect of working with you on this important matter and are confident that your expertise will be invaluable to GenomeDx's case. Please do not hesitate to contact me directly at (415) 762-4112 or at cbloom@calderwoodharkness.com if you have any questions regarding the terms of this Engagement Letter or the scope of the engagement.
Sincerely,
CALDERWOOD & HARKNESS LLP
By: ________
Catherine Bloom Partner, intellectual Property 555 Mission Street, Suite 3100 San Francisco, California 94105 Telephone: (415) 762-4112
Email: cbloom@calderwoodharkness.com
ACCEPTED AND AGREED
________________________________________
Dr. Franklin Ogawa, PhD Professor of Computational Oncology Stanford University
Date: ________
________________________________________
Catherine Bloom Partner, Calderwood & Harkness LLP
Date: ________
ENCLOSURES
Enclosure 1: Stipulated Protective Order (entered December 18, 2025)
Enclosure 2: Acknowledgment and Agreement to Be Bound (Protective Order, Exhibit A)
Enclosure 3: Copies of U.S. Patent No. 10,438,271; U.S. Patent No. 11,204,893; and U.S. Patent No. 11,891,647
Enclosure 4: Complaint for Patent Infringement, Genome Dx Therapeutics Inc. v. Helios Precision Diagnostics, Inc., Case No. 3:25-cv-01847-JWL (filed March 28, 2025)
Enclosure 5: Scheduling Order (entered June 18, 2025)
cc: Victoria Sung, General Counsel, Genome Dx Therapeutics Inc. cc: Alan Ngo, Calderwood & Harkness LLP cc: Peter Vassiliev, Calderwood & Harkness LLP

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CALDERWOOD & HARKNESS LLP

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