1013-00005 · Genome Dx Therapeutics Inc · Discovery/Protective Order

stipulated-protective-order.docx DOCUMENT Litigation

14 / 35 ← → ✕

UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA SAN FRANCISCO DIVISION

STIPULATED PROTECTIVE ORDER

WHEREAS, the parties to this Action — Plaintiff Genome Dx Therapeutics Inc. ("GenomeDx" or "Plaintiff"), represented by Calderwood & Harkness LLP, 555 Mission Street, Suite 3100, San Francisco, California 94105, and Defendant Helios Precision Diagnostics, Inc. ("Helios" or "Defendant"), represented by Ridgecrest Durneval LLP, One Federal Street, Suite 3400, Boston, Massachusetts 02110 and 350 South Grand Avenue, Suite 2800, Los Angeles, California 90071 — have stipulated and agreed to the entry of this Protective Order governing the treatment of confidential, proprietary, and trade-secret information produced or disclosed in discovery in this Action;

WHEREAS, this Action involves claims and defenses relating to United States Patent Nos. 10,438,271 (entitled "Genomic Classifier for Cancer Prognosis Using Multi-Gene Expression Signatures"), 11,204,893 (entitled "Methods and Systems for Predicting Cancer Recurrence Using Machine-Learning Models"), and 11,891,647 (entitled "Integrated Genomic Classifier Platform with Automated Feature Selection"), and Defendant's accused ProstaSignal™ Genomic Classifier product, including allegations of patent infringement, willful infringement, and induced infringement, as well as Defendant's affirmative defenses and counterclaims of non-infringement, invalidity, and unenforceability;

WHEREAS, the parties recognize and acknowledge that discovery in this Action will necessarily involve the disclosure of confidential, proprietary, and trade-secret information of both parties, including but not limited to proprietary genomic classifier algorithms, training data, feature selection methodologies, model architectures and hyperparameters, clinical validation data, regulatory submissions, business plans, financial records, revenue and cost data, licensing agreements and related correspondence, investor materials, board of directors presentations, strategic planning documents, and other commercially sensitive information the unauthorized disclosure of which would cause substantial competitive and commercial harm;

WHEREAS, counsel for the parties conducted a meet-and-confer on December 5, 2025, during which they negotiated the terms and provisions of this Protective Order in good faith, consistent with the requirements of Federal Rule of Civil Procedure 26(c), Civil Local Rule 7-1, and this Court's standing orders regarding discovery dispute resolution;

WHEREAS, good cause exists under Federal Rule of Civil Procedure 26(c) for the entry of this Order to protect against the disclosure and dissemination of confidential, proprietary, and trade-secret information outside the confines of this litigation, as the information at issue includes trade secrets, proprietary algorithms, and highly sensitive competitive information the public disclosure of which would cause substantial and irreparable harm to the Designating Party; and

WHEREAS, the Court, having reviewed the parties' stipulation and the good cause established therefor, finds that entry of this Order is warranted and appropriate to facilitate the efficient and orderly exchange of discovery in this Action while protecting the legitimate confidentiality interests of the parties and non-parties;

NOW, THEREFORE, upon the stipulation of the parties, and for good cause shown, IT IS HEREBY ORDERED as follows:

Section 1: Definitions

As used in this Stipulated Protective Order, the following terms shall have the meanings set forth below:

1.1 "Action" shall mean the civil action captioned Genome Dx Therapeutics Inc. v. Helios Precision Diagnostics, Inc., Case No. 3:25-cv-01847-JWL, pending in the United States District Court for the Northern District of California, including all proceedings, motions, hearings, trials, post-trial proceedings, and appeals arising therefrom.

1.2 "Protected Material" shall mean any document, electronically stored information ("ESI"), deposition testimony, interrogatory response, response to a request for admission, tangible thing, or other information produced, disclosed, exchanged, or filed in this Action that has been designated by a Designating Party as either "Confidential" or "Highly Confidential — Attorneys' Eyes Only" pursuant to the terms and procedures set forth in this Order. Protected Material includes all copies, excerpts, summaries, compilations, abstracts, notes, or other records that contain, reflect, or disclose the substance of information so designated.

1.3 "Confidential" shall mean information that a Designating Party believes in good faith constitutes or contains confidential business, financial, technical, or proprietary information, the disclosure of which to unauthorized persons would cause competitive or commercial harm to the Designating Party. Examples of information that may be designated as Confidential include, but are not limited to, internal business records, financial statements, marketing plans, customer lists, vendor agreements, non-public clinical data, regulatory correspondence, and other commercially sensitive materials.

1.4 "Highly Confidential — Attorneys' Eyes Only" (or "AEO") shall mean information that a Designating Party believes in good faith constitutes or contains trade secrets, proprietary algorithmic methodologies, classifier training data, financial projections, licensing terms, investor communications, or other information of such an extraordinarily sensitive nature that disclosure even to authorized in-house personnel of the opposing party would create a substantial risk of serious competitive injury to the Designating Party. The AEO designation is reserved for the most sensitive categories of information and shall not be used where the Confidential designation would provide adequate protection. Information that may be designated as AEO includes, but is not limited to:

(a) proprietary algorithm source code and software architecture, including genomic classifier source code, compiled binaries, pseudocode, flowcharts, and related technical documentation;

(b) gene-selection methodologies, including proprietary feature engineering techniques, biomarker panel compositions, and related bioinformatics pipelines;

(c) machine-learning model training datasets and parameters, including training cohort composition, validation cohort data, model hyperparameters, performance metrics, and related statistical analyses;

(d) unpublished clinical validation data, including data from ongoing or planned clinical trials, investigator-initiated studies, and registry analyses that have not been made publicly available through peer-reviewed publication or regulatory filing;

(e) freedom-to-operate analyses, patent landscape assessments, and related opinion work product to the extent produced or disclosed in discovery;

(f) detailed financial models, including revenue projections, cost structures, pricing algorithms, reimbursement rate analyses, and unit economics; and

(g) investor presentations, board of directors materials, and strategic planning documents reflecting future business strategy or product development plans.

1.5 "Designating Party" shall mean the party or non-party that designates information or material as Protected Material under this Order. A Designating Party may designate its own information produced in discovery, and a non-party may designate information it produces pursuant to subpoena or informal request.

1.6 "Receiving Party" shall mean the party or non-party that receives Protected Material designated under this Order. For purposes of clarity, a party may simultaneously be a Designating Party with respect to its own information and a Receiving Party with respect to information received from the opposing party or a non-party.

1.7 "Producing Party" shall mean the party or non-party producing documents, ESI, or other information in discovery in this Action, whether in response to Requests for Production of Documents, interrogatories, deposition notices, subpoenas duces tecum, informal requests for production, or otherwise. The term "Producing Party" includes both parties to this Action and any non-parties who produce materials in connection with this Action.

1.8 "Qualified Person" shall mean any individual who is authorized to receive Protected Material of a given designation level as set forth in Section 4 of this Order, and who, to the extent required by Section 5, has executed the Acknowledgment and Agreement to Be Bound attached hereto as Exhibit A.

1.9 "Non-Party" shall mean any person or entity that is not a named party to this Action but produces documents, materials, or information subject to this Order, including but not limited to third parties served with subpoenas duces tecum or deposition subpoenas. Non-Parties known to the parties as of the date of this Order include Corinth Ventures Fund III, LP; Veridian Molecular Labs, Inc.; and Cascadia Genomics, Inc. This list is illustrative and not exhaustive, and this Order shall apply to any Non-Party who produces materials in connection with this Action.

1.10 "Counsel of Record" shall mean Calderwood & Harkness LLP for Plaintiff and Ridgecrest Durneval LLP for Defendant, and any successor, associated, or additional counsel admitted to practice before this Court in this Action or admitted pro hac vice for purposes of this Action.

1.11 "Outside Counsel" shall mean attorneys and professional staff (including paralegals, legal assistants, legal secretaries, summer associates, and law clerks) employed by or working under the direct supervision of Counsel of Record who are not employees, officers, directors, or agents of any party to this Action.

1.12 "In-House Counsel" shall mean attorneys employed by a party to this Action who are admitted to practice law in at least one state of the United States and who provide legal services to that party. As of the date of this Order, the In-House Counsel specifically identified by the parties are:

(a) For GenomeDx: Victoria Sung, General Counsel; and Dr. Kevin Ostrowski, Vice President of intellectual Property;

(b) For Helios: Sara Whitmore, General Counsel.

Additional In-House Counsel may be designated by written notice to opposing counsel, subject to the restrictions set forth in Section 4 of this Order.

1.13 "Expert" or "Consultant" shall mean any person retained or specially employed by a party or its Counsel of Record to provide expert testimony, consulting services, technical analysis, or other specialized assistance in connection with this Action. As of the date of this Order, the parties have identified the following Experts and Consultants: Dr. Franklin Ogawa (retained by Plaintiff) and Dr. Louise Tremaine (retained by Plaintiff). Defendant reserves the right to identify its retained experts and consultants in accordance with the Court's scheduling order. Additional Experts or Consultants may be designated by written notice to opposing counsel, subject to compliance with Section 5 of this Order.

1.14 "Court" shall mean the United States District Court for the Northern District of California, including any judge, magistrate judge, special master, court-appointed mediator, or other judicial officer assigned to this Action or to any proceeding arising from or related to this Action.

Section 2: Scope of the Protective Order

2.1 This Order governs all documents, electronically stored information ("ESI"), deposition testimony, interrogatory responses, responses to requests for admission, responses to requests for production, hearing and trial testimony, exhibits, declarations, expert reports, and any other discovery materials or litigation materials produced, disclosed, exchanged, or filed in this Action. This Order applies regardless of the medium or format in which such materials exist, including paper documents, electronic files, databases, recordings, and tangible objects.

2.2 This Order applies equally to information produced by the parties and by Non-Parties, whether such information is produced pursuant to a formal subpoena, an informal request for production, a voluntary disclosure, or any other mechanism. Any Non-Party producing materials in connection with this Action may invoke the protections of this Order by designating its materials in accordance with Section 3 below.

2.3 Nothing in this Order shall prevent a party from using or disclosing its own confidential information, or information it originally created or owned, without restriction. A party's obligations under this Order pertain solely to Protected Material received from the opposing party or from a Non-Party. For the avoidance of doubt, a Designating Party retains full and unrestricted rights to use, disclose, and disseminate its own information regardless of any designation made under this Order.

2.4 This Order does not alter, diminish, or enlarge any party's obligations or rights under the Federal Rules of Civil Procedure, the Federal Rules of Evidence, Civil Local Rules of this Court, or applicable case law with respect to the production of discoverable information. Disagreements about the scope of discovery, the discoverability of particular information, or the applicability of any privilege or protection are governed by the Federal Rules of Civil Procedure, the Federal Rules of Evidence, and applicable case law, and are not affected by the existence of this Order. The designation of material as Protected Material under this Order does not constitute a concession that the material is relevant, discoverable, or admissible.

Section 3: Designation Procedures

3.1 Designation of Documents and ESI. The Designating Party shall designate documents and ESI as Protected Material by marking each page of a document or each item of ESI with the appropriate legend: either "CONFIDENTIAL" or "HIGHLY CONFIDENTIAL — ATTORNEYS' EYES ONLY." Such markings shall be placed in a conspicuous location on each page, such as a header, footer, or Bates-number stamp field. For ESI produced in native format (including but not limited to spreadsheets, databases, source code, and multimedia files), the designation shall appear in the corresponding load file, metadata field, or in a cover email or cover letter accompanying the production that specifically identifies the files and the applicable designation level. All designations must be made at or before the time of production. A Designating Party that fails to designate material at the time of production may later designate such material by providing written notice to all Counsel of Record, specifying the Bates numbers or other unique identifiers of the affected materials and the applicable designation. Upon receipt of such notice, the Receiving Party shall treat the newly designated material in accordance with this Order from that point forward but shall not be deemed to have violated the Order by virtue of any prior handling of the material consistent with its original (undesignated) status.

3.2 Designation of Deposition Testimony. During depositions taken in this Action, counsel for any party or Non-Party may designate deposition testimony as "Confidential" or "Highly Confidential — Attorneys' Eyes Only" on the record by stating the designation at the time the testimony is given. Such designation shall apply to all testimony given from the point of designation until the designating attorney states on the record that the designation is lifted. When testimony is designated as AEO during a deposition, all persons present in the deposition room (whether in person or remotely via videoconference) who are not Qualified Persons authorized to receive AEO material under Section 4.2 of this Order must leave the deposition room (or be removed from the videoconference) for the duration of the AEO-designated testimony. The court reporter shall note on the record the departure and return of any such persons. In addition to on-the-record designations made during the deposition, each party shall have twenty-one (21) calendar days after receipt of the final certified deposition transcript to designate additional portions of the transcript as Protected Material by providing written notice to all Counsel of Record specifying the page and line numbers of the testimony to be designated and the applicable designation level. Until the expiration of such twenty-one-day designation period, the entire deposition transcript shall be treated as AEO by all parties and their counsel.

3.3 Designation of Interrogatory Responses and Other Written discovery. Responses to interrogatories, requests for admission, and other written discovery may be designated as Protected Material by including the appropriate legend — "CONFIDENTIAL" or "HIGHLY CONFIDENTIAL — ATTORNEYS' EYES ONLY" — on each page of the response, or alternatively by providing a cover letter or cover email that accompanies the discovery response and specifically identifies which responses, or portions thereof, are designated and at what level. Where a cover letter is used, the letter must identify the designated material with sufficient specificity to enable the Receiving Party to determine which information is subject to which designation level.

3.4 Designation in Good Faith. All designations under this Order must be made in good faith and must be based upon a reasonable belief that the designated material qualifies for protection under the applicable designation level as defined in Sections 1.3 and 1.4. Mass or blanket designations of entire document productions, deposition transcripts, or discovery responses without individualized review of the materials being designated are prohibited. A party shall not designate material as "Highly Confidential — Attorneys' Eyes Only" unless it genuinely believes, based upon the nature and content of the specific material, that disclosure to the opposing party's In-House Counsel or business personnel would create a substantial risk of serious competitive harm. The parties acknowledge their continuing obligation to review and, where appropriate, adjust designations as the litigation progresses and as the sensitivity of particular information may change over time.

Section 4: Access to Protected Material — Two-Tier Framework

4.1 "Confidential" Material — Authorized Recipients. Information and materials designated as "Confidential" under this Order may be disclosed only to the following categories of Qualified Persons:

(a) Outside Counsel of Record and their professional staff, including attorneys, paralegals, legal assistants, summer associates, law clerks, and other personnel employed by or working under the direct supervision of Counsel of Record who are engaged in the prosecution or defense of this Action. For Plaintiff, this includes Calderwood & Harkness LLP personnel, specifically including Catherine Bloom, Alan Ngo, Peter Vassiliev, Wendy Schultz, and such other attorneys, paralegals, and staff as are or may be assigned to work on this matter. For Defendant, this includes Ridgecrest Durneval LLP personnel, specifically including Marcus Pellegrini, Danielle Forrest, Owen Chu, and such other attorneys, paralegals, and staff as are or may be assigned to work on this matter.

(b) In-House Counsel of the Receiving Party who have signed the Acknowledgment and Agreement to Be Bound attached hereto as Exhibit A, provided that such In-House Counsel do not have primary operational or competitive decision-making responsibilities relating to the specific subject matter of the Confidential information at issue. Specifically, the following In-House Counsel are authorized to receive Confidential material, subject to execution of Exhibit A: Victoria Sung (General Counsel, GenomeDx), Dr. Kevin Ostrowski (Vice President, intellectual Property, GenomeDx), and Sara Whitmore (General Counsel, Helios). Additional In-House Counsel may be authorized by written notice to opposing counsel, subject to the same restrictions.

(c) Up to two (2) designated in-house business employees of the Receiving Party per topic area, identified in writing to the Designating Party at least five (5) business days before such employees are given access to the Confidential material, who have signed Exhibit A. "Topic area" as used in this subsection refers to the general subject matter of the Confidential material (e.g., technical/algorithmic information, financial information, regulatory information, or commercial/marketing information). The Designating Party may object to any identified employee within five (5) business days of receiving the identification, and the parties shall meet and confer regarding any such objection. If the objection cannot be resolved, the matter shall be referred to the Court.

(d) Experts and Consultants retained by the Receiving Party or its Counsel of Record for purposes of this Action, who have signed Exhibit A. The Receiving Party shall identify each such Expert or Consultant to the opposing party before disclosing Confidential material to that person.

(e) E-discovery vendors and litigation-support providers, including Canfield Document Solutions LLC (Sandra Neville, project manager) and any corresponding vendor retained by Defendant, and their employees who require access to Protected Material in order to perform document processing, review-platform hosting, data analytics, trial-support, or other litigation-support services in connection with this Action, provided that each such employee with access has signed Exhibit A.

(f) The Court and its staff; court reporters and videographers engaged for depositions, hearings, or trial; mediators appointed by the Court or agreed upon by the parties; and any special master appointed in this Action.

(g) Witnesses during depositions or at trial, solely for the purpose of examination, subject to the requirements of Section 6 below. A witness's access to Confidential material shown during a deposition or at trial does not authorize the witness to retain copies of such material after the conclusion of the witness's testimony, unless separately authorized.

4.2 "Highly Confidential — Attorneys' Eyes Only" Material — Authorized Recipients. Information and materials designated as "Highly Confidential — Attorneys' Eyes Only" under this Order may be disclosed only to the following categories of Qualified Persons:

(a) Outside Counsel of Record and their professional staff, as identified and described in Section 4.1(a) above. For the avoidance of doubt, this includes all attorneys, paralegals, legal assistants, and other professional staff employed by Calderwood & Harkness LLP and Ridgecrest Durneval LLP who are working on this Action.

(b) Experts and Consultants retained by the Receiving Party or its Counsel of Record for purposes of this Action, who have signed Exhibit A, subject to the additional restriction that such Experts and Consultants may not be current officers, directors, employees, or paid consultants (other than in connection with this Action) of any competitor of the Designating Party. For purposes of this provision, a "competitor" is any entity that develops, manufactures, markets, sells, or offers for sale genomic diagnostic products or services, including but not limited to genomic classifiers for cancer prognosis, diagnosis, or treatment selection. If the Receiving Party wishes to retain an Expert or Consultant who may arguably fall within this restriction, the Receiving Party shall notify the Designating Party in writing at least ten (10) business days before disclosing AEO material to such person, and the parties shall meet and confer regarding any objection.

(c) E-discovery vendors and litigation-support providers who have signed Exhibit A, solely for purposes of document processing, hosting, review-platform support, and related technical services (e.g., Canfield Document Solutions LLC operating the RevealIQ document review platform), and only to the extent reasonably necessary for such vendors and providers to perform their assigned functions. Access by vendor personnel shall be limited to those employees with a demonstrated need-to-know in connection with providing litigation-support services for this Action.

(d) The Court and its staff; court reporters and videographers engaged for depositions, hearings, or trial; mediators appointed by the Court or agreed upon by the parties; and any special master appointed in this Action.

(e) AEO material may NOT be disclosed to any In-House Counsel or business employee of the Receiving Party without the prior written consent of the Designating Party or an order of the Court. Any request for such disclosure shall be made in writing to the Designating Party's Counsel of Record, and the Designating Party shall respond within ten (10) business days. If the Designating Party does not consent, the Receiving Party may seek relief from the Court.

(f) AEO material may NOT be disclosed to any officer, director, employee, or agent of the Receiving Party other than Outside Counsel and their professional staff as described in Section 4.2(a) above. This restriction applies regardless of whether such officer, director, employee, or agent has signed Exhibit A.

4.3 Patent Prosecution Bar. No Outside Counsel or Expert who receives AEO material in this Action shall participate in, advise on, or consult regarding the prosecution of any patent or patent application before the United States Patent and Trademark Office ("USPTO") or any foreign patent office, including but not limited to original prosecution, continuation prosecution, reissue prosecution, reexamination proceedings, inter partes review proceedings, post-grant review proceedings, and covered business method review proceedings, where the subject matter of the patent or patent application relates to genomic classifier methods for cancer prognosis, diagnosis, or treatment selection, for a period of eighteen (18) months after the conclusion of this Action, including the exhaustion or expiration of all appeals. This bar shall apply to the drafting of claims, the preparation of responses to office actions, the preparation of petitions for inter partes review or post-grant review, and the provision of strategic advice regarding prosecution strategy for such patents or patent applications. This bar does not apply to patent litigation counseling, the rendering of infringement or validity opinions, freedom-to-operate analyses, or other opinion work product unrelated to prosecution before a patent office. Any Outside Counsel or Expert subject to this bar shall certify compliance upon request by the Designating Party.

Section 5: Acknowledgment and Agreement to Be Bound (Exhibit A)

5.1 Before receiving any Protected Material, whether designated as "Confidential" or "Highly Confidential — Attorneys' Eyes Only," each non-counsel recipient identified in Section 4 who is required to sign the Acknowledgment (including In-House Counsel, in-house business employees, Experts, Consultants, e-discovery vendor personnel, and Non-Party deponents) must execute the Acknowledgment and Agreement to Be Bound attached hereto as Exhibit A. Outside Counsel of Record and their professional staff are bound by this Order by virtue of their appearance in this Action and are not required to execute Exhibit A, although they may do so voluntarily.

5.2 The Acknowledgment and Agreement to Be Bound shall include the following information and commitments:

(a) The signatory's full legal name, employer or affiliated organization, and title or position;

(b) A confirmation that the signatory has read the Stipulated Protective Order entered by the Court on December 18, 2025, in its entirety and understands the terms, conditions, and obligations set forth therein;

(c) An agreement to be bound by all provisions of this Order and to submit to the personal jurisdiction of the United States District Court for the Northern District of California for purposes of any proceeding to enforce compliance with this Order;

(d) An agreement not to use Protected Material received pursuant to this Order for any purpose other than the prosecution or defense of this Action, as more fully described in Section 11 of this Order; and

(e) An agreement to return or destroy all Protected Material in the signatory's possession, custody, or control upon the conclusion of the signatory's role in this Action or upon the request of the party from whom the Protected Material was received, in accordance with Section 12 of this Order.

5.3 Copies of all signed Acknowledgments shall be retained by Counsel of Record for the party that obtained the signature. Signed Acknowledgments shall be produced to opposing counsel upon written request within five (5) business days. Signed Acknowledgments need not be filed with the Court unless the Court so orders or unless filing becomes necessary in connection with an enforcement proceeding.

Section 6: Use of Protected Material at Depositions

6.1 Protected Material may be shown to a deponent during a deposition in this Action for purposes of examination, but the deponent must first be informed on the record of the confidentiality designation applicable to the material being displayed. The examining attorney shall state on the record whether the exhibit or document being shown to the witness is designated as "Confidential" or "Highly Confidential — Attorneys' Eyes Only" before the witness is permitted to review the material.

6.2 If AEO material is to be used during a deposition, all persons present in the deposition room (or participating remotely via videoconference) who are not Qualified Persons authorized to view AEO material under Section 4.2 of this Order must leave the deposition room (or be removed from the videoconference) for the duration of the AEO examination. This includes, without limitation, In-House Counsel and business employees of the Receiving Party who have not been authorized by the Designating Party or the Court to receive AEO material. The court reporter shall note on the record the identity of persons who depart and when they return. If a dispute arises during a deposition regarding the exclusion of a particular individual, the parties shall follow the procedures for challenging designations set forth in Section 8 below, and the individual shall be excluded pending resolution of the dispute.

6.3 Deponents who are not parties to this Action and who are not employees of a party must execute the Acknowledgment and Agreement to Be Bound (Exhibit A) before being shown any Protected Material during a deposition. Counsel for the party noticing the deposition shall be responsible for providing Exhibit A to the deponent in advance of the deposition and for ensuring that the executed Acknowledgment is obtained before Protected Material is displayed.

6.4 A party's own employees may view that party's own Protected Material without restriction during a deposition or otherwise. For the avoidance of doubt, a GenomeDx employee who is a deponent may review GenomeDx's own Protected Material freely, and a Helios employee who is a deponent may review Helios's own Protected Material freely, regardless of the designation level of such material.

Section 7: Filing Protected Material with the Court

7.1 Protected Material shall not be filed on the public docket of this Action. Any filing that includes, incorporates, attaches, quotes from, or refers to the substance of Protected Material shall be filed under seal in accordance with Civil Local Rule 79-5 of the Northern District of California and this Court's standing orders regarding sealed filings. The parties shall comply with all procedural requirements for filing under seal, including the use of designated sealed-filing envelopes for physical documents and the Court's ECF procedures for electronic sealed filings.

7.2 The party seeking to file material under seal shall contemporaneously submit a declaration or declarations establishing that the material qualifies for sealing under the applicable legal standard. For dispositive motions and attachments thereto, the filing party must demonstrate "compelling reasons" for sealing, as required by the Ninth Circuit's decision in Kamakana v. City and County of Honolulu, 447 F.3d 1172 (9th Cir. 2006). For non-dispositive motions and other discovery-related filings, the filing party must demonstrate "good cause" for sealing under Phillips ex rel. Estates of Byrd v. General Motors Corp., 307 F.3d 1206 (9th Cir. 2002), and related authority. The Designating Party shall cooperate with the filing party in preparing the required declaration(s) and shall provide the necessary factual basis for the sealing request.

7.3 Redacted versions of all filings that contain or reference Protected Material shall be filed on the public docket simultaneously with the sealed filing, unless the Court orders otherwise. Redactions shall be limited to the specific Protected Material and shall not be used to redact information that is publicly available, that has been disclosed in open court, or that does not qualify for protection under this Order. The parties shall endeavor to minimize the extent of redactions and to make as much of each filing publicly available as is consistent with the protections of this Order.

7.4 If the parties disagree about whether particular material warrants sealing, the Designating Party bears the burden of justifying the seal by submitting a declaration establishing the specific harm that would result from public disclosure, consistent with the applicable legal standard. The filing party is not required to seek sealing of material that the Designating Party cannot or will not justify.

Section 8: Challenging Designations

8.1 A Receiving Party that believes a designation of material as "Confidential" or "Highly Confidential — Attorneys' Eyes Only" is improper, overbroad, or not supported by good cause may challenge that designation at any time during the pendency of this Action. Nothing in this Order shall be construed to limit or waive a party's right to challenge any designation.

8.2 Meet-and-Confer Requirement. Before filing any motion with the Court to challenge a designation, the challenging party must provide written notice to the Designating Party identifying the specific materials at issue (by Bates number, exhibit number, deposition transcript page and line, or other unique identifier) and the basis for the challenge. The parties shall meet and confer in good faith within ten (10) business days of such notice in a genuine effort to resolve the dispute without Court intervention. The meet-and-confer may be conducted in person, by telephone, or by videoconference, as the parties agree. This meet-and-confer procedure is consistent with the collaborative approach the parties employed during the meet-and-confer conducted on December 5, 2025, which led to the negotiation and stipulation of this Order, and reflects the expectations of Civil Local Rule 37-1 and this Court's standing orders regarding discovery dispute resolution.

8.3 If the meet-and-confer does not resolve the dispute, the challenging party may file a motion with the Court seeking to modify or remove the designation. Discovery-related designation disputes shall be referred to Magistrate Judge David R. Cabrera in accordance with the referral order in this Action. In any such motion, the Designating Party bears the burden of establishing that the challenged designation is proper and that the designated material qualifies for protection at the level assigned. The challenging party shall identify the specific materials at issue and articulate the basis for the challenge. The motion shall comply with all applicable local rules regarding page limits, formatting, and the joint discovery dispute letter procedure, if applicable.

8.4 Pending resolution of any challenge under this Section, the material at issue shall continue to be treated at the designation level assigned by the Designating Party. No party or person shall be permitted to disclose or use the challenged material in a manner inconsistent with its current designation while a challenge is pending, unless the Court orders otherwise.

Section 9: Inadvertent Production of Privileged Material — Clawback

9.1 The production or disclosure of a document, ESI, or other material in this Action shall not constitute a waiver of any applicable attorney-client privilege, work-product protection, or any other applicable privilege or protection, whether or not the production or disclosure was inadvertent. This provision is entered pursuant to, and shall be enforceable in accordance with, Federal Rule of Evidence 502(d), which provides that a federal court may order that the privilege or protection is not waived by disclosure connected with the litigation pending before the court, and that such an order is enforceable against all persons or entities in all federal and state proceedings. This Order is intended to constitute such an order.

9.2 If a Producing Party discovers that it has inadvertently produced privileged or work-product-protected material, the Producing Party shall promptly notify the Receiving Party in writing (which may be by email to Counsel of Record). The notification shall identify the material by Bates number, document description, or other unique identifier, and shall identify the privilege or protection asserted (e.g., attorney-client privilege, work-product doctrine, joint-defense privilege, or common-interest privilege). The Producing Party is not required to provide a detailed privilege log entry at the time of the clawback notification, but shall supplement the notification with a privilege log entry within fourteen (14) days.

9.3 Upon receipt of a clawback notification under Section 9.2, the Receiving Party shall:

(a) promptly return, sequester, or destroy all copies of the identified material in its possession, custody, or control, including all copies in the possession of Outside Counsel, In-House Counsel, Experts, Consultants, and e-discovery vendors;

(b) not use or disclose the content of the identified material for any purpose pending resolution of the privilege or protection claim; and

(c) take reasonable steps to retrieve any copies of the identified material that have already been provided to third parties, Experts, Consultants, or other persons, and to ensure that such persons are notified of the clawback and instructed to return, sequester, or destroy their copies.

9.4 If the Receiving Party disputes the privilege or protection claim asserted by the Producing Party, the Receiving Party may raise the issue with the Court by motion, but must sequester and refrain from using or disclosing the identified material pending the Court's resolution of the dispute. The Producing Party bears the burden of establishing that the clawed-back material is privileged or protected.

9.5 This provision is without prejudice to any party's right to challenge privilege assertions on a privilege log or to seek production of materials for which privilege has been asserted, including without limitation the eighty-three (83) documents withheld by Helios on the basis of privilege, thirty-four (34) of which are the subject of GenomeDx's Motion to Compel filed on January 30, 2026 (Dkt. No. __). Nothing in this Order shall be deemed to resolve or prejudge the pending motion to compel or any other dispute regarding the propriety of privilege assertions in this Action.

Section 10: Non-Party Productions

10.1 Non-Parties producing documents, ESI, or other information in connection with this Action may designate such material as "Confidential" or "Highly Confidential — Attorneys' Eyes Only" in accordance with the terms and procedures of this Order, as if they were a Designating Party under Section 3. A Non-Party may invoke the protections of this Order by marking its produced materials with the appropriate legend or by providing a cover letter specifying the applicable designation level.

10.2 A Non-Party's designation of material as Protected Material shall be subject to challenge under Section 8 of this Order, and the same procedures (including the meet-and-confer requirement) shall apply. In the event a challenge to a Non-Party's designation is raised, the party or parties that subpoenaed the Non-Party's materials shall use reasonable efforts to notify the Non-Party of the challenge and to afford the Non-Party an opportunity to be heard, either directly or through counsel.

10.3 The parties shall provide a copy of this Order to any Non-Party from whom they seek discovery in this Action, including with any subpoena duces tecum, deposition subpoena, or informal request for production. The parties shall inform the Non-Party that it has the right to designate its materials under this Order and shall provide the Non-Party with a reasonable opportunity to review and designate its materials before such materials are disclosed to the opposing party.

Section 11: No Use Outside this Action

11.1 Protected Material received by a Receiving Party shall be used solely for the purpose of prosecuting or defending this Action, including pre-trial discovery, motion practice, trial preparation, trial, post-trial proceedings, and appeals. Protected Material shall not be used for any business, commercial, competitive, regulatory, or other purpose unrelated to this Action.

11.2 Without limiting the generality of Section 11.1, Protected Material shall not be used in connection with any of the following:

(a) any other litigation, arbitration, or dispute resolution proceeding, whether pending or contemplated;

(b) any patent prosecution, including the preparation or prosecution of patent applications, responses to office actions, or petitions for inter partes review or post-grant review before the USPTO or any foreign patent office;

(d) any regulatory proceeding, including proceedings before the U.S. Food and Drug Administration, the Centers for Medicare & Medicaid Services, or any other governmental agency;

(e) any business development activity, including product development, market analysis, competitive intelligence, or strategic planning; or

(f) any investment decision, including decisions regarding the acquisition, disposition, or valuation of securities, equity interests, or assets.

The foregoing restrictions apply except as may be required by applicable law, regulation, or court order, in which case the Receiving Party shall provide the Designating Party with prompt written notice and a reasonable opportunity to seek a protective order or other relief before any such required disclosure is made.

11.3 Nothing in this Section 11 prevents a party from using its own information for any purpose. A party's use of its own information, whether or not such information has been designated as Protected Material in this Action, is unrestricted by this Order.

Section 12: Duration and Disposition of Protected Material

12.1 This Order shall remain in full force and effect throughout the pendency of this Action and for a period of two (2) years after the final resolution of this Action, including the exhaustion or expiration of all rights of appeal. The obligations of confidentiality imposed by this Order shall not expire during this period, and all Qualified Persons who have received Protected Material shall remain bound by this Order during this period.

12.2 Within sixty (60) days after the conclusion of this Action (including all appeals and the expiration of all appeal deadlines), each Receiving Party shall, at the Designating Party's election (to be communicated in writing to the Receiving Party), either:

(a) Return all Protected Material (including all copies, excerpts, summaries, compilations, notes, and other records containing or reflecting Protected Material) to the Designating Party; or

(b) Destroy all Protected Material (including all copies, excerpts, summaries, compilations, notes, and other records containing or reflecting Protected Material) and certify such destruction in writing to the Designating Party. The certification shall be signed by a partner or senior attorney of Counsel of Record and shall state that all Protected Material has been destroyed and that reasonable steps have been taken to confirm the completeness of the destruction, including the deletion of electronic copies from document review platforms, litigation-support databases, and counsel's own files and systems.

Notwithstanding the foregoing, Outside Counsel of Record may retain one (1) archival copy of Protected Material (which may be in electronic form) solely for the purpose of resolving any post-litigation disputes regarding compliance with this Order, establishing a record of the proceedings, or addressing any claims of malpractice or ethical misconduct. Such archival copy shall remain subject to all of the confidentiality obligations of this Order for the duration specified in Section 12.1.

12.3 The provisions of this Order, including without limitation the obligations of confidentiality and non-use set forth in Sections 4 and 11, shall survive the termination of this Action and the return or destruction of Protected Material. This Order shall continue to be enforceable by the Court, and any person who has signed the Acknowledgment (Exhibit A) shall remain subject to the jurisdiction of this Court for enforcement purposes, notwithstanding the conclusion of this Action.

Section 13: Modification

13.1 This Order may be modified at any time by written stipulation of the parties, approved by the Court, or by order of the Court upon motion by any party or affected Non-Party. Any stipulated modification shall be filed with the Court and shall not be effective until approved by the Court.

13.2 Any party or Non-Party may seek modification of this Order upon a showing of good cause. Good cause for modification may include, without limitation, a change in circumstances that renders a provision of this Order unduly burdensome, impractical, or inadequate to protect legitimate confidentiality interests; the identification of additional categories of information requiring protection; or a need to expand or restrict the categories of Qualified Persons authorized to receive Protected Material.

Section 14: Enforcement

14.1 Any violation of this Order may be addressed by the Court through its contempt power, the imposition of sanctions, the entry of injunctive relief, or any other remedy available under applicable law or the Court's inherent authority. The Court may also consider any violation of this Order in connection with other motions or proceedings in this Action, including motions for sanctions under Federal Rule of Civil Procedure 37 or the Court's inherent authority.

14.2 Any person who has signed the Acknowledgment and Agreement to Be Bound (Exhibit A) is subject to the personal jurisdiction of the United States District Court for the Northern District of California for purposes of enforcement of this Order, regardless of whether such person is otherwise subject to the jurisdiction of this Court. By signing Exhibit A, each signatory consents to such jurisdiction and waives any objection based on lack of personal jurisdiction, improper venue, or inconvenient forum with respect to proceedings to enforce this Order.

14.3 The Court may award reasonable attorneys' fees and costs incurred by a party in enforcing this Order against any party or person found to have violated its terms. Such an award may be made in addition to any other remedy imposed by the Court, and shall be assessed against the violating party or person, or against counsel whose conduct contributed to the violation, as the Court deems appropriate.

Section 15: Miscellaneous

15.1 This Order does not create any presumption as to the discoverability, relevance, or admissibility of any material. The designation of material as Protected Material under this Order does not constitute an admission or concession by any party that the material is relevant, discoverable, or admissible for any purpose. All rights to object to the discoverability, relevance, or admissibility of any material are fully preserved.

15.2 This Order does not limit the right of any party to seek additional or different protections from the Court with respect to particular materials or categories of materials, whether by motion, stipulation, or otherwise. Any party may seek a further protective order under Federal Rule of Civil Procedure 26(c) with respect to any specific discovery dispute or category of information.

15.3 Nothing in this Order prevents Counsel of Record from disclosing to their client the general nature, significance, or legal implications of Protected Material received from the opposing party or a Non-Party, provided that the specific content, substance, or text of AEO material is not disclosed to any person who is not authorized to receive such material under Section 4.2 of this Order. For example, Outside Counsel may inform their client that documents received from the opposing party bear upon a particular issue or support a particular legal theory, without revealing the specific data, terms, figures, or other substantive content contained in the AEO material.

15.4 This Order shall be governed by and construed in accordance with federal law, including the Federal Rules of Civil Procedure, the Federal Rules of Evidence, and applicable decisions of the United States Court of Appeals for the Ninth Circuit and the United States District Court for the Northern District of California. To the extent any provision of this Order conflicts with applicable federal law, federal law shall control.

IT IS SO STIPULATED.

For Plaintiff Genome Dx Therapeutics Inc.:

CALDERWOOD & HARKNESS LLP

By: ________

Catherine Bloom, Partner 555 Mission Street, Suite 3100 San Francisco, California 94105 Telephone: (415) 773-6200

Email: cbloom@calderwoodharkness.com

Attorneys for Plaintiff Genome Dx Therapeutics Inc.

Dated: December 18, 2025

For Defendant Helios Precision Diagnostics, Inc.:

RIDGECREST DURNEVAL LLP

By: ________

Marcus Pellegrini, Partner One Federal Street, Suite 3400 Boston, Massachusetts 02110 Telephone: (617) 854-3100

Email: mpellegrini@ridgecrestkirkpatrick.com

Attorneys for Defendant Helios Precision Diagnostics, Inc.

Dated: December 18, 2025

ORDER

The Court, having reviewed the foregoing Stipulated Protective Order and the parties' stipulation, and finding good cause shown pursuant to Federal Rule of Civil Procedure 26(c) for the protections set forth herein, hereby ORDERS that the foregoing Stipulated Protective Order is APPROVED and ENTERED as an Order of this Court.

The protections set forth in this Order, including the provisions regarding the inadvertent production of privileged material, are entered pursuant to Federal Rule of Evidence 502(d), and are binding on all persons and entities in all federal and state proceedings.

IT IS SO ORDERED.

Dated: December 18, 2025

________________________________________

HON. JESSICA W. LANGSTON United States District Judge Northern District of California

EXHIBIT A

ACKNOWLEDGMENT AND AGREEMENT TO BE BOUND BY STIPULATED PROTECTIVE ORDER

UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA SAN FRANCISCO DIVISION

I, __________ [Full Legal Name], holding the position of ________ [Title/Position], employed by or affiliated with __________ [Organization], hereby declare and agree as follows:

1. I have read the Stipulated Protective Order entered by the Court on December 18, 2025, in the above-captioned Action (the "Protective Order") in its entirety, and I understand the terms, conditions, obligations, and restrictions set forth therein.

2. I agree to be bound by all provisions of the Protective Order as if I were a signatory thereto. I understand that the Protective Order restricts the use and disclosure of certain confidential, proprietary, and trade-secret information designated as "Confidential" or "Highly Confidential — Attorneys' Eyes Only" in connection with the above-captioned Action.

3. I agree that I will not disclose, disseminate, copy, or use any Protected Material (as defined in the Protective Order) for any purpose other than the prosecution or defense of the above-captioned Action. I will not discuss the substance or content of Protected Material with any person who is not a Qualified Person authorized to receive such material under the terms of the Protective Order.

4. I agree that I will maintain all Protected Material in a secure manner, will not leave copies of Protected Material unattended in areas accessible to unauthorized persons, and will take reasonable precautions to prevent unauthorized access to Protected Material in both physical and electronic form.

5. I agree that I will return or destroy all Protected Material in my possession, custody, or control upon the completion of my role in the above-captioned Action, upon the conclusion of the Action (as directed by Counsel of Record), or upon the request of the party from whom the Protected Material was received, in accordance with Section 12 of the Protective Order.

6. I submit to the personal jurisdiction of the United States District Court for the Northern District of California for the purpose of any proceeding to enforce the Protective Order. I waive any objection based on lack of personal jurisdiction, improper venue, or inconvenient forum with respect to any such enforcement proceeding.

7. I understand that any violation of the Protective Order may result in sanctions, contempt proceedings, or other penalties imposed by the Court, and that I may be held personally liable for any damages resulting from my violation of the Protective Order.

Signature: ________

Printed Name: ________

Title/Position: ________

Employer/Affiliation: ________

Address: ________

Date: ________

GENOME DX THERAPEUTICS INC., a Delaware corporation,	Case No. 3:25-cv-01847-JWL
<!-- indent:2 -->Plaintiff,<!-- /indent -->	Hon. Jessica W. Langston

United States District Judge

Hon. David R. Cabrera

HELIOS PRECISION DIAGNOSTICS, INC., a Massachusetts corporation,

(assigned for discovery disputes)

Defendant.

GENOME DX THERAPEUTICS INC.,

Plaintiff,

v.	Hon. Jessica W. Langston
HELIOS PRECISION DIAGNOSTICS, INC.,	Hon. David R. Cabrera

Defendant.

UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA SAN FRANCISCO DIVISION
STIPULATED PROTECTIVE ORDER
WHEREAS, the parties to this Action — Plaintiff Genome Dx Therapeutics Inc. ("GenomeDx" or "Plaintiff"), represented by Calderwood & Harkness LLP, 555 Mission Street, Suite 3100, San Francisco, California 94105, and Defendant Helios Precision Diagnostics, Inc. ("Helios" or "Defendant"), represented by Ridgecrest Durneval LLP, One Federal Street, Suite 3400, Boston, Massachusetts 02110 and 350 South Grand Avenue, Suite 2800, Los Angeles, California 90071 — have stipulated and agreed to the entry of this Protective Order governing the treatment of confidential, proprietary, and trade-secret information produced or disclosed in discovery in this Action;
WHEREAS, this Action involves claims and defenses relating to United States Patent Nos. 10,438,271 (entitled "Genomic Classifier for Cancer Prognosis Using Multi-Gene Expression Signatures"), 11,204,893 (entitled "Methods and Systems for Predicting Cancer Recurrence Using Machine-Learning Models"), and 11,891,647 (entitled "Integrated Genomic Classifier Platform with Automated Feature Selection"), and Defendant's accused ProstaSignal™ Genomic Classifier product, including allegations of patent infringement, willful infringement, and induced infringement, as well as Defendant's affirmative defenses and counterclaims of non-infringement, invalidity, and unenforceability;
WHEREAS, the parties recognize and acknowledge that discovery in this Action will necessarily involve the disclosure of confidential, proprietary, and trade-secret information of both parties, including but not limited to proprietary genomic classifier algorithms, training data, feature selection methodologies, model architectures and hyperparameters, clinical validation data, regulatory submissions, business plans, financial records, revenue and cost data, licensing agreements and related correspondence, investor materials, board of directors presentations, strategic planning documents, and other commercially sensitive information the unauthorized disclosure of which would cause substantial competitive and commercial harm;
WHEREAS, counsel for the parties conducted a meet-and-confer on December 5, 2025, during which they negotiated the terms and provisions of this Protective Order in good faith, consistent with the requirements of Federal Rule of Civil Procedure 26(c), Civil Local Rule 7-1, and this Court's standing orders regarding discovery dispute resolution;
WHEREAS, good cause exists under Federal Rule of Civil Procedure 26(c) for the entry of this Order to protect against the disclosure and dissemination of confidential, proprietary, and trade-secret information outside the confines of this litigation, as the information at issue includes trade secrets, proprietary algorithms, and highly sensitive competitive information the public disclosure of which would cause substantial and irreparable harm to the Designating Party; and
WHEREAS, the Court, having reviewed the parties' stipulation and the good cause established therefor, finds that entry of this Order is warranted and appropriate to facilitate the efficient and orderly exchange of discovery in this Action while protecting the legitimate confidentiality interests of the parties and non-parties;
NOW, THEREFORE, upon the stipulation of the parties, and for good cause shown, IT IS HEREBY ORDERED as follows:
Section 1: Definitions
As used in this Stipulated Protective Order, the following terms shall have the meanings set forth below:
1.1 "Action" shall mean the civil action captioned Genome Dx Therapeutics Inc. v. Helios Precision Diagnostics, Inc., Case No. 3:25-cv-01847-JWL, pending in the United States District Court for the Northern District of California, including all proceedings, motions, hearings, trials, post-trial proceedings, and appeals arising therefrom.
1.2 "Protected Material" shall mean any document, electronically stored information ("ESI"), deposition testimony, interrogatory response, response to a request for admission, tangible thing, or other information produced, disclosed, exchanged, or filed in this Action that has been designated by a Designating Party as either "Confidential" or "Highly Confidential — Attorneys' Eyes Only" pursuant to the terms and procedures set forth in this Order. Protected Material includes all copies, excerpts, summaries, compilations, abstracts, notes, or other records that contain, reflect, or disclose the substance of information so designated.
1.3 "Confidential" shall mean information that a Designating Party believes in good faith constitutes or contains confidential business, financial, technical, or proprietary information, the disclosure of which to unauthorized persons would cause competitive or commercial harm to the Designating Party. Examples of information that may be designated as Confidential include, but are not limited to, internal business records, financial statements, marketing plans, customer lists, vendor agreements, non-public clinical data, regulatory correspondence, and other commercially sensitive materials.
1.4 "Highly Confidential — Attorneys' Eyes Only" (or "AEO") shall mean information that a Designating Party believes in good faith constitutes or contains trade secrets, proprietary algorithmic methodologies, classifier training data, financial projections, licensing terms, investor communications, or other information of such an extraordinarily sensitive nature that disclosure even to authorized in-house personnel of the opposing party would create a substantial risk of serious competitive injury to the Designating Party. The AEO designation is reserved for the most sensitive categories of information and shall not be used where the Confidential designation would provide adequate protection. Information that may be designated as AEO includes, but is not limited to:
(a) proprietary algorithm source code and software architecture, including genomic classifier source code, compiled binaries, pseudocode, flowcharts, and related technical documentation;
(b) gene-selection methodologies, including proprietary feature engineering techniques, biomarker panel compositions, and related bioinformatics pipelines;
(c) machine-learning model training datasets and parameters, including training cohort composition, validation cohort data, model hyperparameters, performance metrics, and related statistical analyses;
(d) unpublished clinical validation data, including data from ongoing or planned clinical trials, investigator-initiated studies, and registry analyses that have not been made publicly available through peer-reviewed publication or regulatory filing;
(e) freedom-to-operate analyses, patent landscape assessments, and related opinion work product to the extent produced or disclosed in discovery;
(f) detailed financial models, including revenue projections, cost structures, pricing algorithms, reimbursement rate analyses, and unit economics; and
(g) investor presentations, board of directors materials, and strategic planning documents reflecting future business strategy or product development plans.
1.5 "Designating Party" shall mean the party or non-party that designates information or material as Protected Material under this Order. A Designating Party may designate its own information produced in discovery, and a non-party may designate information it produces pursuant to subpoena or informal request.
1.6 "Receiving Party" shall mean the party or non-party that receives Protected Material designated under this Order. For purposes of clarity, a party may simultaneously be a Designating Party with respect to its own information and a Receiving Party with respect to information received from the opposing party or a non-party.
1.7 "Producing Party" shall mean the party or non-party producing documents, ESI, or other information in discovery in this Action, whether in response to Requests for Production of Documents, interrogatories, deposition notices, subpoenas duces tecum, informal requests for production, or otherwise. The term "Producing Party" includes both parties to this Action and any non-parties who produce materials in connection with this Action.
1.8 "Qualified Person" shall mean any individual who is authorized to receive Protected Material of a given designation level as set forth in Section 4 of this Order, and who, to the extent required by Section 5, has executed the Acknowledgment and Agreement to Be Bound attached hereto as Exhibit A.
1.9 "Non-Party" shall mean any person or entity that is not a named party to this Action but produces documents, materials, or information subject to this Order, including but not limited to third parties served with subpoenas duces tecum or deposition subpoenas. Non-Parties known to the parties as of the date of this Order include Corinth Ventures Fund III, LP; Veridian Molecular Labs, Inc.; and Cascadia Genomics, Inc. This list is illustrative and not exhaustive, and this Order shall apply to any Non-Party who produces materials in connection with this Action.
1.10 "Counsel of Record" shall mean Calderwood & Harkness LLP for Plaintiff and Ridgecrest Durneval LLP for Defendant, and any successor, associated, or additional counsel admitted to practice before this Court in this Action or admitted pro hac vice for purposes of this Action.
1.11 "Outside Counsel" shall mean attorneys and professional staff (including paralegals, legal assistants, legal secretaries, summer associates, and law clerks) employed by or working under the direct supervision of Counsel of Record who are not employees, officers, directors, or agents of any party to this Action.
1.12 "In-House Counsel" shall mean attorneys employed by a party to this Action who are admitted to practice law in at least one state of the United States and who provide legal services to that party. As of the date of this Order, the In-House Counsel specifically identified by the parties are:
(a) For GenomeDx: Victoria Sung, General Counsel; and Dr. Kevin Ostrowski, Vice President of intellectual Property;
(b) For Helios: Sara Whitmore, General Counsel.
Additional In-House Counsel may be designated by written notice to opposing counsel, subject to the restrictions set forth in Section 4 of this Order.
1.13 "Expert" or "Consultant" shall mean any person retained or specially employed by a party or its Counsel of Record to provide expert testimony, consulting services, technical analysis, or other specialized assistance in connection with this Action. As of the date of this Order, the parties have identified the following Experts and Consultants: Dr. Franklin Ogawa (retained by Plaintiff) and Dr. Louise Tremaine (retained by Plaintiff). Defendant reserves the right to identify its retained experts and consultants in accordance with the Court's scheduling order. Additional Experts or Consultants may be designated by written notice to opposing counsel, subject to compliance with Section 5 of this Order.
1.14 "Court" shall mean the United States District Court for the Northern District of California, including any judge, magistrate judge, special master, court-appointed mediator, or other judicial officer assigned to this Action or to any proceeding arising from or related to this Action.
Section 2: Scope of the Protective Order
2.1 This Order governs all documents, electronically stored information ("ESI"), deposition testimony, interrogatory responses, responses to requests for admission, responses to requests for production, hearing and trial testimony, exhibits, declarations, expert reports, and any other discovery materials or litigation materials produced, disclosed, exchanged, or filed in this Action. This Order applies regardless of the medium or format in which such materials exist, including paper documents, electronic files, databases, recordings, and tangible objects.
2.2 This Order applies equally to information produced by the parties and by Non-Parties, whether such information is produced pursuant to a formal subpoena, an informal request for production, a voluntary disclosure, or any other mechanism. Any Non-Party producing materials in connection with this Action may invoke the protections of this Order by designating its materials in accordance with Section 3 below.
2.3 Nothing in this Order shall prevent a party from using or disclosing its own confidential information, or information it originally created or owned, without restriction. A party's obligations under this Order pertain solely to Protected Material received from the opposing party or from a Non-Party. For the avoidance of doubt, a Designating Party retains full and unrestricted rights to use, disclose, and disseminate its own information regardless of any designation made under this Order.
2.4 This Order does not alter, diminish, or enlarge any party's obligations or rights under the Federal Rules of Civil Procedure, the Federal Rules of Evidence, Civil Local Rules of this Court, or applicable case law with respect to the production of discoverable information. Disagreements about the scope of discovery, the discoverability of particular information, or the applicability of any privilege or protection are governed by the Federal Rules of Civil Procedure, the Federal Rules of Evidence, and applicable case law, and are not affected by the existence of this Order. The designation of material as Protected Material under this Order does not constitute a concession that the material is relevant, discoverable, or admissible.
Section 3: Designation Procedures
3.1 Designation of Documents and ESI. The Designating Party shall designate documents and ESI as Protected Material by marking each page of a document or each item of ESI with the appropriate legend: either "CONFIDENTIAL" or "HIGHLY CONFIDENTIAL — ATTORNEYS' EYES ONLY." Such markings shall be placed in a conspicuous location on each page, such as a header, footer, or Bates-number stamp field. For ESI produced in native format (including but not limited to spreadsheets, databases, source code, and multimedia files), the designation shall appear in the corresponding load file, metadata field, or in a cover email or cover letter accompanying the production that specifically identifies the files and the applicable designation level. All designations must be made at or before the time of production. A Designating Party that fails to designate material at the time of production may later designate such material by providing written notice to all Counsel of Record, specifying the Bates numbers or other unique identifiers of the affected materials and the applicable designation. Upon receipt of such notice, the Receiving Party shall treat the newly designated material in accordance with this Order from that point forward but shall not be deemed to have violated the Order by virtue of any prior handling of the material consistent with its original (undesignated) status.
3.2 Designation of Deposition Testimony. During depositions taken in this Action, counsel for any party or Non-Party may designate deposition testimony as "Confidential" or "Highly Confidential — Attorneys' Eyes Only" on the record by stating the designation at the time the testimony is given. Such designation shall apply to all testimony given from the point of designation until the designating attorney states on the record that the designation is lifted. When testimony is designated as AEO during a deposition, all persons present in the deposition room (whether in person or remotely via videoconference) who are not Qualified Persons authorized to receive AEO material under Section 4.2 of this Order must leave the deposition room (or be removed from the videoconference) for the duration of the AEO-designated testimony. The court reporter shall note on the record the departure and return of any such persons. In addition to on-the-record designations made during the deposition, each party shall have twenty-one (21) calendar days after receipt of the final certified deposition transcript to designate additional portions of the transcript as Protected Material by providing written notice to all Counsel of Record specifying the page and line numbers of the testimony to be designated and the applicable designation level. Until the expiration of such twenty-one-day designation period, the entire deposition transcript shall be treated as AEO by all parties and their counsel.
3.3 Designation of Interrogatory Responses and Other Written discovery. Responses to interrogatories, requests for admission, and other written discovery may be designated as Protected Material by including the appropriate legend — "CONFIDENTIAL" or "HIGHLY CONFIDENTIAL — ATTORNEYS' EYES ONLY" — on each page of the response, or alternatively by providing a cover letter or cover email that accompanies the discovery response and specifically identifies which responses, or portions thereof, are designated and at what level. Where a cover letter is used, the letter must identify the designated material with sufficient specificity to enable the Receiving Party to determine which information is subject to which designation level.
3.4 Designation in Good Faith. All designations under this Order must be made in good faith and must be based upon a reasonable belief that the designated material qualifies for protection under the applicable designation level as defined in Sections 1.3 and 1.4. Mass or blanket designations of entire document productions, deposition transcripts, or discovery responses without individualized review of the materials being designated are prohibited. A party shall not designate material as "Highly Confidential — Attorneys' Eyes Only" unless it genuinely believes, based upon the nature and content of the specific material, that disclosure to the opposing party's In-House Counsel or business personnel would create a substantial risk of serious competitive harm. The parties acknowledge their continuing obligation to review and, where appropriate, adjust designations as the litigation progresses and as the sensitivity of particular information may change over time.
Section 4: Access to Protected Material — Two-Tier Framework
4.1 "Confidential" Material — Authorized Recipients. Information and materials designated as "Confidential" under this Order may be disclosed only to the following categories of Qualified Persons:
(a) Outside Counsel of Record and their professional staff, including attorneys, paralegals, legal assistants, summer associates, law clerks, and other personnel employed by or working under the direct supervision of Counsel of Record who are engaged in the prosecution or defense of this Action. For Plaintiff, this includes Calderwood & Harkness LLP personnel, specifically including Catherine Bloom, Alan Ngo, Peter Vassiliev, Wendy Schultz, and such other attorneys, paralegals, and staff as are or may be assigned to work on this matter. For Defendant, this includes Ridgecrest Durneval LLP personnel, specifically including Marcus Pellegrini, Danielle Forrest, Owen Chu, and such other attorneys, paralegals, and staff as are or may be assigned to work on this matter.
(b) In-House Counsel of the Receiving Party who have signed the Acknowledgment and Agreement to Be Bound attached hereto as Exhibit A, provided that such In-House Counsel do not have primary operational or competitive decision-making responsibilities relating to the specific subject matter of the Confidential information at issue. Specifically, the following In-House Counsel are authorized to receive Confidential material, subject to execution of Exhibit A: Victoria Sung (General Counsel, GenomeDx), Dr. Kevin Ostrowski (Vice President, intellectual Property, GenomeDx), and Sara Whitmore (General Counsel, Helios). Additional In-House Counsel may be authorized by written notice to opposing counsel, subject to the same restrictions.
(c) Up to two (2) designated in-house business employees of the Receiving Party per topic area, identified in writing to the Designating Party at least five (5) business days before such employees are given access to the Confidential material, who have signed Exhibit A. "Topic area" as used in this subsection refers to the general subject matter of the Confidential material (e.g., technical/algorithmic information, financial information, regulatory information, or commercial/marketing information). The Designating Party may object to any identified employee within five (5) business days of receiving the identification, and the parties shall meet and confer regarding any such objection. If the objection cannot be resolved, the matter shall be referred to the Court.
(d) Experts and Consultants retained by the Receiving Party or its Counsel of Record for purposes of this Action, who have signed Exhibit A. The Receiving Party shall identify each such Expert or Consultant to the opposing party before disclosing Confidential material to that person.
(e) E-discovery vendors and litigation-support providers, including Canfield Document Solutions LLC (Sandra Neville, project manager) and any corresponding vendor retained by Defendant, and their employees who require access to Protected Material in order to perform document processing, review-platform hosting, data analytics, trial-support, or other litigation-support services in connection with this Action, provided that each such employee with access has signed Exhibit A.
(f) The Court and its staff; court reporters and videographers engaged for depositions, hearings, or trial; mediators appointed by the Court or agreed upon by the parties; and any special master appointed in this Action.
(g) Witnesses during depositions or at trial, solely for the purpose of examination, subject to the requirements of Section 6 below. A witness's access to Confidential material shown during a deposition or at trial does not authorize the witness to retain copies of such material after the conclusion of the witness's testimony, unless separately authorized.
4.2 "Highly Confidential — Attorneys' Eyes Only" Material — Authorized Recipients. Information and materials designated as "Highly Confidential — Attorneys' Eyes Only" under this Order may be disclosed only to the following categories of Qualified Persons:
(a) Outside Counsel of Record and their professional staff, as identified and described in Section 4.1(a) above. For the avoidance of doubt, this includes all attorneys, paralegals, legal assistants, and other professional staff employed by Calderwood & Harkness LLP and Ridgecrest Durneval LLP who are working on this Action.
(b) Experts and Consultants retained by the Receiving Party or its Counsel of Record for purposes of this Action, who have signed Exhibit A, subject to the additional restriction that such Experts and Consultants may not be current officers, directors, employees, or paid consultants (other than in connection with this Action) of any competitor of the Designating Party. For purposes of this provision, a "competitor" is any entity that develops, manufactures, markets, sells, or offers for sale genomic diagnostic products or services, including but not limited to genomic classifiers for cancer prognosis, diagnosis, or treatment selection. If the Receiving Party wishes to retain an Expert or Consultant who may arguably fall within this restriction, the Receiving Party shall notify the Designating Party in writing at least ten (10) business days before disclosing AEO material to such person, and the parties shall meet and confer regarding any objection.
(c) E-discovery vendors and litigation-support providers who have signed Exhibit A, solely for purposes of document processing, hosting, review-platform support, and related technical services (e.g., Canfield Document Solutions LLC operating the RevealIQ document review platform), and only to the extent reasonably necessary for such vendors and providers to perform their assigned functions. Access by vendor personnel shall be limited to those employees with a demonstrated need-to-know in connection with providing litigation-support services for this Action.
(d) The Court and its staff; court reporters and videographers engaged for depositions, hearings, or trial; mediators appointed by the Court or agreed upon by the parties; and any special master appointed in this Action.
(e) AEO material may NOT be disclosed to any In-House Counsel or business employee of the Receiving Party without the prior written consent of the Designating Party or an order of the Court. Any request for such disclosure shall be made in writing to the Designating Party's Counsel of Record, and the Designating Party shall respond within ten (10) business days. If the Designating Party does not consent, the Receiving Party may seek relief from the Court.
(f) AEO material may NOT be disclosed to any officer, director, employee, or agent of the Receiving Party other than Outside Counsel and their professional staff as described in Section 4.2(a) above. This restriction applies regardless of whether such officer, director, employee, or agent has signed Exhibit A.
4.3 Patent Prosecution Bar. No Outside Counsel or Expert who receives AEO material in this Action shall participate in, advise on, or consult regarding the prosecution of any patent or patent application before the United States Patent and Trademark Office ("USPTO") or any foreign patent office, including but not limited to original prosecution, continuation prosecution, reissue prosecution, reexamination proceedings, inter partes review proceedings, post-grant review proceedings, and covered business method review proceedings, where the subject matter of the patent or patent application relates to genomic classifier methods for cancer prognosis, diagnosis, or treatment selection, for a period of eighteen (18) months after the conclusion of this Action, including the exhaustion or expiration of all appeals. This bar shall apply to the drafting of claims, the preparation of responses to office actions, the preparation of petitions for inter partes review or post-grant review, and the provision of strategic advice regarding prosecution strategy for such patents or patent applications. This bar does not apply to patent litigation counseling, the rendering of infringement or validity opinions, freedom-to-operate analyses, or other opinion work product unrelated to prosecution before a patent office. Any Outside Counsel or Expert subject to this bar shall certify compliance upon request by the Designating Party.
Section 5: Acknowledgment and Agreement to Be Bound (Exhibit A)
5.1 Before receiving any Protected Material, whether designated as "Confidential" or "Highly Confidential — Attorneys' Eyes Only," each non-counsel recipient identified in Section 4 who is required to sign the Acknowledgment (including In-House Counsel, in-house business employees, Experts, Consultants, e-discovery vendor personnel, and Non-Party deponents) must execute the Acknowledgment and Agreement to Be Bound attached hereto as Exhibit A. Outside Counsel of Record and their professional staff are bound by this Order by virtue of their appearance in this Action and are not required to execute Exhibit A, although they may do so voluntarily.
5.2 The Acknowledgment and Agreement to Be Bound shall include the following information and commitments:
(a) The signatory's full legal name, employer or affiliated organization, and title or position;
(b) A confirmation that the signatory has read the Stipulated Protective Order entered by the Court on December 18, 2025, in its entirety and understands the terms, conditions, and obligations set forth therein;
(c) An agreement to be bound by all provisions of this Order and to submit to the personal jurisdiction of the United States District Court for the Northern District of California for purposes of any proceeding to enforce compliance with this Order;
(d) An agreement not to use Protected Material received pursuant to this Order for any purpose other than the prosecution or defense of this Action, as more fully described in Section 11 of this Order; and
(e) An agreement to return or destroy all Protected Material in the signatory's possession, custody, or control upon the conclusion of the signatory's role in this Action or upon the request of the party from whom the Protected Material was received, in accordance with Section 12 of this Order.
5.3 Copies of all signed Acknowledgments shall be retained by Counsel of Record for the party that obtained the signature. Signed Acknowledgments shall be produced to opposing counsel upon written request within five (5) business days. Signed Acknowledgments need not be filed with the Court unless the Court so orders or unless filing becomes necessary in connection with an enforcement proceeding.
Section 6: Use of Protected Material at Depositions
6.1 Protected Material may be shown to a deponent during a deposition in this Action for purposes of examination, but the deponent must first be informed on the record of the confidentiality designation applicable to the material being displayed. The examining attorney shall state on the record whether the exhibit or document being shown to the witness is designated as "Confidential" or "Highly Confidential — Attorneys' Eyes Only" before the witness is permitted to review the material.
6.2 If AEO material is to be used during a deposition, all persons present in the deposition room (or participating remotely via videoconference) who are not Qualified Persons authorized to view AEO material under Section 4.2 of this Order must leave the deposition room (or be removed from the videoconference) for the duration of the AEO examination. This includes, without limitation, In-House Counsel and business employees of the Receiving Party who have not been authorized by the Designating Party or the Court to receive AEO material. The court reporter shall note on the record the identity of persons who depart and when they return. If a dispute arises during a deposition regarding the exclusion of a particular individual, the parties shall follow the procedures for challenging designations set forth in Section 8 below, and the individual shall be excluded pending resolution of the dispute.
6.3 Deponents who are not parties to this Action and who are not employees of a party must execute the Acknowledgment and Agreement to Be Bound (Exhibit A) before being shown any Protected Material during a deposition. Counsel for the party noticing the deposition shall be responsible for providing Exhibit A to the deponent in advance of the deposition and for ensuring that the executed Acknowledgment is obtained before Protected Material is displayed.
6.4 A party's own employees may view that party's own Protected Material without restriction during a deposition or otherwise. For the avoidance of doubt, a GenomeDx employee who is a deponent may review GenomeDx's own Protected Material freely, and a Helios employee who is a deponent may review Helios's own Protected Material freely, regardless of the designation level of such material.
Section 7: Filing Protected Material with the Court
7.1 Protected Material shall not be filed on the public docket of this Action. Any filing that includes, incorporates, attaches, quotes from, or refers to the substance of Protected Material shall be filed under seal in accordance with Civil Local Rule 79-5 of the Northern District of California and this Court's standing orders regarding sealed filings. The parties shall comply with all procedural requirements for filing under seal, including the use of designated sealed-filing envelopes for physical documents and the Court's ECF procedures for electronic sealed filings.
7.2 The party seeking to file material under seal shall contemporaneously submit a declaration or declarations establishing that the material qualifies for sealing under the applicable legal standard. For dispositive motions and attachments thereto, the filing party must demonstrate "compelling reasons" for sealing, as required by the Ninth Circuit's decision in Kamakana v. City and County of Honolulu, 447 F.3d 1172 (9th Cir. 2006). For non-dispositive motions and other discovery-related filings, the filing party must demonstrate "good cause" for sealing under Phillips ex rel. Estates of Byrd v. General Motors Corp., 307 F.3d 1206 (9th Cir. 2002), and related authority. The Designating Party shall cooperate with the filing party in preparing the required declaration(s) and shall provide the necessary factual basis for the sealing request.
7.3 Redacted versions of all filings that contain or reference Protected Material shall be filed on the public docket simultaneously with the sealed filing, unless the Court orders otherwise. Redactions shall be limited to the specific Protected Material and shall not be used to redact information that is publicly available, that has been disclosed in open court, or that does not qualify for protection under this Order. The parties shall endeavor to minimize the extent of redactions and to make as much of each filing publicly available as is consistent with the protections of this Order.
7.4 If the parties disagree about whether particular material warrants sealing, the Designating Party bears the burden of justifying the seal by submitting a declaration establishing the specific harm that would result from public disclosure, consistent with the applicable legal standard. The filing party is not required to seek sealing of material that the Designating Party cannot or will not justify.
Section 8: Challenging Designations
8.1 A Receiving Party that believes a designation of material as "Confidential" or "Highly Confidential — Attorneys' Eyes Only" is improper, overbroad, or not supported by good cause may challenge that designation at any time during the pendency of this Action. Nothing in this Order shall be construed to limit or waive a party's right to challenge any designation.
8.2 Meet-and-Confer Requirement. Before filing any motion with the Court to challenge a designation, the challenging party must provide written notice to the Designating Party identifying the specific materials at issue (by Bates number, exhibit number, deposition transcript page and line, or other unique identifier) and the basis for the challenge. The parties shall meet and confer in good faith within ten (10) business days of such notice in a genuine effort to resolve the dispute without Court intervention. The meet-and-confer may be conducted in person, by telephone, or by videoconference, as the parties agree. This meet-and-confer procedure is consistent with the collaborative approach the parties employed during the meet-and-confer conducted on December 5, 2025, which led to the negotiation and stipulation of this Order, and reflects the expectations of Civil Local Rule 37-1 and this Court's standing orders regarding discovery dispute resolution.
8.3 If the meet-and-confer does not resolve the dispute, the challenging party may file a motion with the Court seeking to modify or remove the designation. Discovery-related designation disputes shall be referred to Magistrate Judge David R. Cabrera in accordance with the referral order in this Action. In any such motion, the Designating Party bears the burden of establishing that the challenged designation is proper and that the designated material qualifies for protection at the level assigned. The challenging party shall identify the specific materials at issue and articulate the basis for the challenge. The motion shall comply with all applicable local rules regarding page limits, formatting, and the joint discovery dispute letter procedure, if applicable.
8.4 Pending resolution of any challenge under this Section, the material at issue shall continue to be treated at the designation level assigned by the Designating Party. No party or person shall be permitted to disclose or use the challenged material in a manner inconsistent with its current designation while a challenge is pending, unless the Court orders otherwise.
Section 9: Inadvertent Production of Privileged Material — Clawback
9.1 The production or disclosure of a document, ESI, or other material in this Action shall not constitute a waiver of any applicable attorney-client privilege, work-product protection, or any other applicable privilege or protection, whether or not the production or disclosure was inadvertent. This provision is entered pursuant to, and shall be enforceable in accordance with, Federal Rule of Evidence 502(d), which provides that a federal court may order that the privilege or protection is not waived by disclosure connected with the litigation pending before the court, and that such an order is enforceable against all persons or entities in all federal and state proceedings. This Order is intended to constitute such an order.
9.2 If a Producing Party discovers that it has inadvertently produced privileged or work-product-protected material, the Producing Party shall promptly notify the Receiving Party in writing (which may be by email to Counsel of Record). The notification shall identify the material by Bates number, document description, or other unique identifier, and shall identify the privilege or protection asserted (e.g., attorney-client privilege, work-product doctrine, joint-defense privilege, or common-interest privilege). The Producing Party is not required to provide a detailed privilege log entry at the time of the clawback notification, but shall supplement the notification with a privilege log entry within fourteen (14) days.
9.3 Upon receipt of a clawback notification under Section 9.2, the Receiving Party shall:
(a) promptly return, sequester, or destroy all copies of the identified material in its possession, custody, or control, including all copies in the possession of Outside Counsel, In-House Counsel, Experts, Consultants, and e-discovery vendors;
(b) not use or disclose the content of the identified material for any purpose pending resolution of the privilege or protection claim; and
(c) take reasonable steps to retrieve any copies of the identified material that have already been provided to third parties, Experts, Consultants, or other persons, and to ensure that such persons are notified of the clawback and instructed to return, sequester, or destroy their copies.
9.4 If the Receiving Party disputes the privilege or protection claim asserted by the Producing Party, the Receiving Party may raise the issue with the Court by motion, but must sequester and refrain from using or disclosing the identified material pending the Court's resolution of the dispute. The Producing Party bears the burden of establishing that the clawed-back material is privileged or protected.
9.5 This provision is without prejudice to any party's right to challenge privilege assertions on a privilege log or to seek production of materials for which privilege has been asserted, including without limitation the eighty-three (83) documents withheld by Helios on the basis of privilege, thirty-four (34) of which are the subject of GenomeDx's Motion to Compel filed on January 30, 2026 (Dkt. No. __). Nothing in this Order shall be deemed to resolve or prejudge the pending motion to compel or any other dispute regarding the propriety of privilege assertions in this Action.
Section 10: Non-Party Productions
10.1 Non-Parties producing documents, ESI, or other information in connection with this Action may designate such material as "Confidential" or "Highly Confidential — Attorneys' Eyes Only" in accordance with the terms and procedures of this Order, as if they were a Designating Party under Section 3. A Non-Party may invoke the protections of this Order by marking its produced materials with the appropriate legend or by providing a cover letter specifying the applicable designation level.
10.2 A Non-Party's designation of material as Protected Material shall be subject to challenge under Section 8 of this Order, and the same procedures (including the meet-and-confer requirement) shall apply. In the event a challenge to a Non-Party's designation is raised, the party or parties that subpoenaed the Non-Party's materials shall use reasonable efforts to notify the Non-Party of the challenge and to afford the Non-Party an opportunity to be heard, either directly or through counsel.
10.3 The parties shall provide a copy of this Order to any Non-Party from whom they seek discovery in this Action, including with any subpoena duces tecum, deposition subpoena, or informal request for production. The parties shall inform the Non-Party that it has the right to designate its materials under this Order and shall provide the Non-Party with a reasonable opportunity to review and designate its materials before such materials are disclosed to the opposing party.
Section 11: No Use Outside this Action
11.1 Protected Material received by a Receiving Party shall be used solely for the purpose of prosecuting or defending this Action, including pre-trial discovery, motion practice, trial preparation, trial, post-trial proceedings, and appeals. Protected Material shall not be used for any business, commercial, competitive, regulatory, or other purpose unrelated to this Action.
11.2 Without limiting the generality of Section 11.1, Protected Material shall not be used in connection with any of the following:
(a) any other litigation, arbitration, or dispute resolution proceeding, whether pending or contemplated;
(b) any patent prosecution, including the preparation or prosecution of patent applications, responses to office actions, or petitions for inter partes review or post-grant review before the USPTO or any foreign patent office;
(c) any patent licensing negotiation or licensing transaction;
(d) any regulatory proceeding, including proceedings before the U.S. Food and Drug Administration, the Centers for Medicare & Medicaid Services, or any other governmental agency;
(e) any business development activity, including product development, market analysis, competitive intelligence, or strategic planning; or
(f) any investment decision, including decisions regarding the acquisition, disposition, or valuation of securities, equity interests, or assets.
The foregoing restrictions apply except as may be required by applicable law, regulation, or court order, in which case the Receiving Party shall provide the Designating Party with prompt written notice and a reasonable opportunity to seek a protective order or other relief before any such required disclosure is made.
11.3 Nothing in this Section 11 prevents a party from using its own information for any purpose. A party's use of its own information, whether or not such information has been designated as Protected Material in this Action, is unrestricted by this Order.
Section 12: Duration and Disposition of Protected Material
12.1 This Order shall remain in full force and effect throughout the pendency of this Action and for a period of two (2) years after the final resolution of this Action, including the exhaustion or expiration of all rights of appeal. The obligations of confidentiality imposed by this Order shall not expire during this period, and all Qualified Persons who have received Protected Material shall remain bound by this Order during this period.
12.2 Within sixty (60) days after the conclusion of this Action (including all appeals and the expiration of all appeal deadlines), each Receiving Party shall, at the Designating Party's election (to be communicated in writing to the Receiving Party), either:
(a) Return all Protected Material (including all copies, excerpts, summaries, compilations, notes, and other records containing or reflecting Protected Material) to the Designating Party; or
(b) Destroy all Protected Material (including all copies, excerpts, summaries, compilations, notes, and other records containing or reflecting Protected Material) and certify such destruction in writing to the Designating Party. The certification shall be signed by a partner or senior attorney of Counsel of Record and shall state that all Protected Material has been destroyed and that reasonable steps have been taken to confirm the completeness of the destruction, including the deletion of electronic copies from document review platforms, litigation-support databases, and counsel's own files and systems.
Notwithstanding the foregoing, Outside Counsel of Record may retain one (1) archival copy of Protected Material (which may be in electronic form) solely for the purpose of resolving any post-litigation disputes regarding compliance with this Order, establishing a record of the proceedings, or addressing any claims of malpractice or ethical misconduct. Such archival copy shall remain subject to all of the confidentiality obligations of this Order for the duration specified in Section 12.1.
12.3 The provisions of this Order, including without limitation the obligations of confidentiality and non-use set forth in Sections 4 and 11, shall survive the termination of this Action and the return or destruction of Protected Material. This Order shall continue to be enforceable by the Court, and any person who has signed the Acknowledgment (Exhibit A) shall remain subject to the jurisdiction of this Court for enforcement purposes, notwithstanding the conclusion of this Action.
Section 13: Modification
13.1 This Order may be modified at any time by written stipulation of the parties, approved by the Court, or by order of the Court upon motion by any party or affected Non-Party. Any stipulated modification shall be filed with the Court and shall not be effective until approved by the Court.
13.2 Any party or Non-Party may seek modification of this Order upon a showing of good cause. Good cause for modification may include, without limitation, a change in circumstances that renders a provision of this Order unduly burdensome, impractical, or inadequate to protect legitimate confidentiality interests; the identification of additional categories of information requiring protection; or a need to expand or restrict the categories of Qualified Persons authorized to receive Protected Material.
Section 14: Enforcement
14.1 Any violation of this Order may be addressed by the Court through its contempt power, the imposition of sanctions, the entry of injunctive relief, or any other remedy available under applicable law or the Court's inherent authority. The Court may also consider any violation of this Order in connection with other motions or proceedings in this Action, including motions for sanctions under Federal Rule of Civil Procedure 37 or the Court's inherent authority.
14.2 Any person who has signed the Acknowledgment and Agreement to Be Bound (Exhibit A) is subject to the personal jurisdiction of the United States District Court for the Northern District of California for purposes of enforcement of this Order, regardless of whether such person is otherwise subject to the jurisdiction of this Court. By signing Exhibit A, each signatory consents to such jurisdiction and waives any objection based on lack of personal jurisdiction, improper venue, or inconvenient forum with respect to proceedings to enforce this Order.
14.3 The Court may award reasonable attorneys' fees and costs incurred by a party in enforcing this Order against any party or person found to have violated its terms. Such an award may be made in addition to any other remedy imposed by the Court, and shall be assessed against the violating party or person, or against counsel whose conduct contributed to the violation, as the Court deems appropriate.
Section 15: Miscellaneous
15.1 This Order does not create any presumption as to the discoverability, relevance, or admissibility of any material. The designation of material as Protected Material under this Order does not constitute an admission or concession by any party that the material is relevant, discoverable, or admissible for any purpose. All rights to object to the discoverability, relevance, or admissibility of any material are fully preserved.
15.2 This Order does not limit the right of any party to seek additional or different protections from the Court with respect to particular materials or categories of materials, whether by motion, stipulation, or otherwise. Any party may seek a further protective order under Federal Rule of Civil Procedure 26(c) with respect to any specific discovery dispute or category of information.
15.3 Nothing in this Order prevents Counsel of Record from disclosing to their client the general nature, significance, or legal implications of Protected Material received from the opposing party or a Non-Party, provided that the specific content, substance, or text of AEO material is not disclosed to any person who is not authorized to receive such material under Section 4.2 of this Order. For example, Outside Counsel may inform their client that documents received from the opposing party bear upon a particular issue or support a particular legal theory, without revealing the specific data, terms, figures, or other substantive content contained in the AEO material.
15.4 This Order shall be governed by and construed in accordance with federal law, including the Federal Rules of Civil Procedure, the Federal Rules of Evidence, and applicable decisions of the United States Court of Appeals for the Ninth Circuit and the United States District Court for the Northern District of California. To the extent any provision of this Order conflicts with applicable federal law, federal law shall control.
IT IS SO STIPULATED.
For Plaintiff Genome Dx Therapeutics Inc.:
CALDERWOOD & HARKNESS LLP
By: ________
Catherine Bloom, Partner 555 Mission Street, Suite 3100 San Francisco, California 94105 Telephone: (415) 773-6200
Email: cbloom@calderwoodharkness.com
Attorneys for Plaintiff Genome Dx Therapeutics Inc.
Dated: December 18, 2025
For Defendant Helios Precision Diagnostics, Inc.:
RIDGECREST DURNEVAL LLP
By: ________
Marcus Pellegrini, Partner One Federal Street, Suite 3400 Boston, Massachusetts 02110 Telephone: (617) 854-3100
Email: mpellegrini@ridgecrestkirkpatrick.com
Attorneys for Defendant Helios Precision Diagnostics, Inc.
Dated: December 18, 2025
ORDER
The Court, having reviewed the foregoing Stipulated Protective Order and the parties' stipulation, and finding good cause shown pursuant to Federal Rule of Civil Procedure 26(c) for the protections set forth herein, hereby ORDERS that the foregoing Stipulated Protective Order is APPROVED and ENTERED as an Order of this Court.
The protections set forth in this Order, including the provisions regarding the inadvertent production of privileged material, are entered pursuant to Federal Rule of Evidence 502(d), and are binding on all persons and entities in all federal and state proceedings.
IT IS SO ORDERED.
Dated: December 18, 2025
________________________________________
HON. JESSICA W. LANGSTON United States District Judge Northern District of California
EXHIBIT A
ACKNOWLEDGMENT AND AGREEMENT TO BE BOUND BY STIPULATED PROTECTIVE ORDER
UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA SAN FRANCISCO DIVISION
I, __________ [Full Legal Name], holding the position of ________ [Title/Position], employed by or affiliated with __________ [Organization], hereby declare and agree as follows:
1.  I have read the Stipulated Protective Order entered by the Court on December 18, 2025, in the above-captioned Action (the "Protective Order") in its entirety, and I understand the terms, conditions, obligations, and restrictions set forth therein.
2.  I agree to be bound by all provisions of the Protective Order as if I were a signatory thereto. I understand that the Protective Order restricts the use and disclosure of certain confidential, proprietary, and trade-secret information designated as "Confidential" or "Highly Confidential — Attorneys' Eyes Only" in connection with the above-captioned Action.
3.  I agree that I will not disclose, disseminate, copy, or use any Protected Material (as defined in the Protective Order) for any purpose other than the prosecution or defense of the above-captioned Action. I will not discuss the substance or content of Protected Material with any person who is not a Qualified Person authorized to receive such material under the terms of the Protective Order.
4.  I agree that I will maintain all Protected Material in a secure manner, will not leave copies of Protected Material unattended in areas accessible to unauthorized persons, and will take reasonable precautions to prevent unauthorized access to Protected Material in both physical and electronic form.
5.  I agree that I will return or destroy all Protected Material in my possession, custody, or control upon the completion of my role in the above-captioned Action, upon the conclusion of the Action (as directed by Counsel of Record), or upon the request of the party from whom the Protected Material was received, in accordance with Section 12 of the Protective Order.
6.  I submit to the personal jurisdiction of the United States District Court for the Northern District of California for the purpose of any proceeding to enforce the Protective Order. I waive any objection based on lack of personal jurisdiction, improper venue, or inconvenient forum with respect to any such enforcement proceeding.
7.  I understand that any violation of the Protective Order may result in sanctions, contempt proceedings, or other penalties imposed by the Court, and that I may be held personally liable for any damages resulting from my violation of the Protective Order.
Signature: ________
Printed Name: ________
Title/Position: ________
Employer/Affiliation: ________
Address: ________
Date: ________
GENOME DX THERAPEUTICS INC., a Delaware corporation, | Case No. 3:25-cv-01847-JWL
<!-- indent:2 -->Plaintiff,<!-- /indent --> | Hon. Jessica W. Langston
United States District Judge
v.
Hon. David R. Cabrera
HELIOS PRECISION DIAGNOSTICS, INC., a Massachusetts corporation, | United States Magistrate Judge
(assigned for discovery disputes)
<!-- indent:2 -->Defendant.<!-- /indent -->
GENOME DX THERAPEUTICS INC., | Case No. 3:25-cv-01847-JWL
<!-- indent:2 -->Plaintiff,<!-- /indent -->
v. | Hon. Jessica W. Langston
HELIOS PRECISION DIAGNOSTICS, INC., | Hon. David R. Cabrera
<!-- indent:2 -->Defendant.<!-- /indent -->

UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA SAN FRANCISCO DIVISION

STIPULATED PROTECTIVE ORDER

IT IS SO STIPULATED.

CALDERWOOD & HARKNESS LLP

RIDGECREST DURNEVAL LLP

IT IS SO ORDERED.

EXHIBIT A

ACKNOWLEDGMENT AND AGREEMENT TO BE BOUND BY STIPULATED PROTECTIVE ORDER

Record

Parties

Dates

Amounts