MEMORANDUM
ATTORNEY-CLIENT PRIVILEGED / ATTORNEY WORK PRODUCT — FOR INTERNAL USE ONLY
TO: Marcus Delgado, Responsible Partner Peter Vassiliev, Working Associate
FROM: Christy Bauer, Lead Associate
DATE: August 1, 2024
RE: Privilege Log Protocol & Guidelines — Apex Surgical Innovations, Inc. v. Solstice Biomedical, Inc., Case No. 1:24-cv-00587-RGA (D. Del.)
MATTER NO.: 10294.0017
CLASSIFICATION: ATTORNEY-CLIENT PRIVILEGED / ATTORNEY WORK PRODUCT — FOR INTERNAL USE ONLY
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I. Purpose and Scope
This memorandum establishes the protocol and guidelines for preparing the privilege log in connection with Solstice Biomedical, Inc.'s document production in the above-captioned patent infringement action. It is intended to serve as the authoritative reference for all reviewers—including Calderwood & Harkness LLP attorneys, contract reviewers, and any coordinating counsel—regarding the identification, coding, and logging of privileged and work-product-protected documents throughout the discovery process in this matter. Strict adherence to the procedures and standards set forth herein is critical to the preservation of all applicable privileges, the avoidance of inadvertent waiver, and compliance with Solstice's obligations under the Federal Rules of Civil Procedure, the Local Rules of the United States District Court for the District of Delaware, and the orders of the Honorable Richard G. Andrews.
Apex Surgical Innovations, Inc. ("Apex") filed its Complaint on May 9, 2024, alleging infringement of U.S. Patent Nos. 9,814,237 (the "'237 Patent"), 10,271,884 (the "'884 Patent"), and 10,932,105 (the "'105 Patent") by Solstice Biomedical, Inc.'s ("Solstice") PrecisionEdge™ PE-5000, PE-12000, and PE-15000 series trocar assemblies. The asserted patents relate generally to surgical trocar designs incorporating specific blade geometry, sealing mechanisms, and retractable sheath features used in minimally invasive surgical procedures. Apex contends that each of the three PrecisionEdge™ product lines infringes multiple claims of the asserted patents, including independent claims and certain dependent claims directed to specific design configurations.
Solstice filed its Answer, Affirmative Defenses, and Counterclaims on June 14, 2024. Solstice's affirmative defenses include non-infringement, invalidity under 35 U.S.C. §§ 102 and 103, inequitable conduct, prosecution history estoppel, and laches. Solstice also asserted counterclaims for declaratory judgment of non-infringement and invalidity. The parties thereafter filed the Joint discovery Plan on July 15, 2024, in accordance with the Court's Scheduling Order, which established the framework for the phased exchange of discovery, including custodian identification, ESI protocols, and the timeline for document productions.
Apex served its First Set of Interrogatories (comprising 18 interrogatories, including subparts) and its First Set of Requests for Production (comprising 42 requests) on August 5, 2024. Solstice served its own First Set of Interrogatories (15 interrogatories) and First Set of Requests for Production (38 requests) on August 19, 2024. Solstice's responses and objections to Apex's discovery are due on September 16, 2024, and the document production is targeted for completion by September 30, 2024, consistent with the schedule established in the Joint discovery Plan.
The anticipated production encompasses approximately 48,217 documents (anticipated Bates Nos. SBD-000001 through SBD-048217), drawn from custodial collections and corporate repositories across both Solstice Biomedical Devices Ltd. (the Irish parent entity, Company Registration Office No. 648217, with principal offices in Dublin, Ireland) and Solstice Biomedical, Inc. (the Delaware subsidiary, Employer Identification Number 84-3291056, with principal offices at 3800 Concord Pike, Suite 410, Wilmington, Delaware 19803). The collection spans multiple data sources, including email accounts, network file shares, local hard drives, portable media, and cloud-based collaboration platforms used by both entities.
The e-discovery workflow is managed by DataVault Litigation Solutions, LLC ("DataVault"), headquartered at 2000 Market Street, Suite 600, Philadelphia, Pennsylvania 19103. DataVault has processed approximately 1.2 terabytes of electronically stored information ("ESI") collected from the identified custodians and corporate repositories. DataVault is conducting technology-assisted review ("TAR") on a corpus of roughly 312,000 documents, pursuant to the TAR Protocol Memorandum dated August 12, 2024, which was separately circulated to the review team and establishes the seed set methodology, iterative training rounds, and statistical validation thresholds governing the TAR process. The privilege review described in this memorandum is integrated into, but distinct from, the responsiveness review conducted under the TAR protocol; documents identified as potentially responsive during the TAR process are routed into the privilege review queue as described in Section IV below.
This protocol applies to all reviewers involved in the first-pass and second-pass review of documents for privilege, including Calderwood & Harkness LLP attorneys assigned to this matter, contract reviewers managed through DataVault's staffing and supervision framework, and any attorneys at Kendrick & Lau LLP ("K&L"), located at 601 Pennsylvania Avenue NW, Suite 820, Washington, DC 20004, who are reviewing documents related to patent prosecution history and freedom-to-operate ("FTO") analysis conducted for Solstice. All such reviewers are expected to familiarize themselves with the entirety of this memorandum before commencing any privilege review and to consult the escalation contacts identified in Section X for guidance on any questions or ambiguities that arise during the review process.
II. Legal Standards for Privilege and Work Product
This section summarizes the legal standards governing attorney-client privilege, attorney work product, and related protections applicable to the privilege review in this matter. While this summary is intended to provide practical guidance to reviewers, it is not exhaustive, and reviewers should consult with Christy Bauer or Marcus Delgado regarding any novel or complex privilege issues that arise during the course of review.
A. Attorney-Client Privilege
The attorney-client privilege protects from disclosure confidential communications between a client and its attorney made for the purpose of seeking or providing legal advice. Under both Delaware law and federal common law—the latter of which governs in this federal question case—the privilege attaches where the following elements are satisfied:
1. A communication was made;
2. The communication was between a client (or the client's authorized agent or representative) and an attorney (or the attorney's agent);
3. The communication was made in confidence (i.e., not disclosed to or in the presence of third parties outside the scope of the privilege);
4. The communication was made for the purpose of seeking or providing legal advice.
The burden of establishing the applicability of the privilege rests on the party asserting it—here, Solstice. Accordingly, the privilege log entries must contain sufficient information to support each element of the privilege for every document withheld or redacted on this basis.
Client Entities. For purposes of this litigation, the "client" encompasses both Solstice Biomedical Devices Ltd. (CRO No. 648217, Ireland), the Irish parent entity, and Solstice Biomedical, Inc. (EIN: 84-3291056, Delaware), the U.S. subsidiary. Both entities are treated as the "client" for privilege purposes given the parent-subsidiary corporate relationship, the integrated management structure, and the fact that both entities are jointly engaged in the defense of this litigation. Communications between personnel of either entity and counsel—whether in-house or outside—are to be treated as potentially privileged, subject to the other requirements of the privilege.
Key Client Personnel. The following individuals are key client personnel whose communications with counsel are most likely to be privileged, and reviewers should be particularly attentive to documents involving these individuals:
• Dr. Fiona Tierney, Chief Executive Officer, Solstice Biomedical Devices Ltd. (Dublin) — Dr. Tierney oversees overall corporate strategy, including litigation strategy, settlement authority, and board-level decision-making regarding the defense of this action.
• Eamon Rourke, General Counsel, Solstice Biomedical Devices Ltd. (Dublin) — Mr. Rourke serves as the chief legal officer for the parent entity and coordinates the company's legal affairs across jurisdictions. His communications with outside counsel are core attorney-client privileged communications. His communications with business personnel that involve the transmission, solicitation, or provision of legal advice are likewise privileged.
• Niamh Cassidy, Vice President, Regulatory & intellectual Property, Solstice Biomedical, Inc. (Wilmington) — Ms. Cassidy occupies a dual role that straddles legal and business functions. She oversees both the regulatory compliance function and the IP strategy for the PrecisionEdge™ product line. Communications involving Ms. Cassidy require particular care and are addressed further in Sections II.A (dual-purpose analysis) and IV.B (second-pass review).
• Brendan Molloy, Chief Financial Officer, Solstice Biomedical, Inc. (Wilmington) — Mr. Molloy is responsible for financial analyses prepared at the direction of counsel, including damages-related financial data, as well as correspondence with Halcyon Specialty Insurance Co. regarding coverage of defense costs.
• Direct Reports of the Above — Communications by direct reports of the foregoing individuals may be privileged where those individuals are communicating at the direction of counsel or are serving as agents of the client for purposes of obtaining or transmitting legal advice. Reviewers should assess on a document-by-document basis whether the communication reflects the direction or involvement of counsel.
Outside Counsel. The following outside counsel and their respective firms are engaged by Solstice for matters related to the asserted patents and this litigation, and their communications with the client are privileged:
• Calderwood & Harkness LLP (Wilmington, DE) — Lead litigation counsel for the defense of Case No. 1:24-cv-00587-RGA. Key attorneys: Marcus Delgado (Partner), Catherine Bloom (Partner), Christy Bauer (Lead Associate), and Peter Vassiliev (Associate).
• Kendrick & Lau LLP (Washington, DC) — Patent prosecution and FTO counsel. Key attorney: Dr. Jonathan Kendrick (Partner). K&L was engaged by Solstice to conduct prior art searches, prepare FTO analyses, and advise on patent prosecution matters relating to the asserted patents and Solstice's own patent portfolio in the surgical device space.
Dual-Purpose Communications. Reviewers must exercise particular caution with respect to communications that serve both a legal and a business purpose. Under the "primary purpose" test applicable in this Circuit, the attorney-client privilege attaches to a dual-purpose communication only if the primary purpose of the communication was to obtain or provide legal advice. Where the primary purpose of a communication is business-related—even if legal advice is incidentally sought or provided—the privilege does not attach. This distinction is especially relevant to communications involving Niamh Cassidy, whose responsibilities encompass both regulatory and IP functions. A communication from Ms. Cassidy to engineering personnel regarding a product design change, for example, is not privileged merely because it references a patent issue; the reviewer must assess whether the primary purpose of the communication was to seek or convey legal advice or to accomplish a business objective. Where the primary purpose is ambiguous or difficult to determine, the document should be coded REVIEW-QC and escalated to second-pass review.
Foreign In-House Counsel. Eamon Rourke serves as General Counsel of the Irish parent entity, Solstice Biomedical Devices Ltd. Under U.S. law, communications with in-house counsel are privileged to the same extent as communications with outside counsel, provided the other elements of the privilege are met. Under Irish law, the scope of legal professional privilege as applied to in-house solicitors or barristers may differ in certain respects from the U.S. standard. Because this litigation is pending in a U.S. federal court, U.S. privilege law governs; however, to the extent that any challenge to privilege arises regarding Mr. Rourke's communications, the intersection of U.S. and Irish privilege principles may become relevant. Reviewers should flag any ambiguity regarding the privileged status of Mr. Rourke's communications—particularly those that may have been shared with non-legal personnel in Ireland or that relate to regulatory or compliance matters under Irish or EU law—for second-pass review by Christy Bauer or Marcus Delgado.
B. Attorney Work Product Doctrine
The attorney work product doctrine, codified at Federal Rule of Civil Procedure 26(b)(3), protects from discovery documents and tangible things that are prepared in anticipation of litigation or for trial by or for a party or its representative, including the party's attorney, consultant, surety, indemnitor, insurer, or agent. The doctrine encompasses two categories of protected material:
• Fact Work Product: Documents and tangible things prepared in anticipation of litigation or for trial. Fact work product is subject to a qualified protection and may be discovered upon a showing of substantial need and the inability to obtain the substantial equivalent of the materials by other means without undue hardship. See Fed. R. Civ. P. 26(b)(3)(A).
• Opinion Work Product: Documents, memoranda, or other materials reflecting the mental impressions, conclusions, opinions, or legal theories of an attorney or other representative of a party concerning the litigation. Opinion work product is entitled to near-absolute protection and is discoverable only in the most extraordinary circumstances. See Fed. R. Civ. P. 26(b)(3)(B); Holmgren v. Brightmoor Indemnity Co., 976 F.2d 573, 577 (9th Cir. 1992).
Litigation Trigger Date. Documents are protected as work product only if they were prepared "in anticipation of litigation." The relevant litigation trigger date in this matter is no later than May 9, 2024—the date on which Apex filed its Complaint. However, the protection may extend to materials prepared prior to the filing of the Complaint if they were prepared in anticipation of this specifically threatened litigation. Critically, Apex sent a cease-and-desist letter to Solstice prior to filing the Complaint, placing Solstice on notice of the potential for patent infringement claims. Accordingly, documents prepared after the receipt of that cease-and-desist letter—and in some cases, documents prepared even earlier if they were prepared in anticipation of threatened litigation involving the asserted patents—may qualify as work product. Reviewers should carefully examine the timing and context of each potentially privileged document and, where uncertainty exists regarding whether a pre-suit document was prepared in anticipation of this litigation, code the document as REVIEW-QC for escalation.
Expert Materials. Materials prepared by experts retained in anticipation of litigation are subject to specific protections under the Federal Rules:
• Dr. Miriam Ostrowski (Halford University, Department of Mechanical Engineering) — Dr. Ostrowski was retained by Calderwood & Harkness LLP on behalf of Solstice pursuant to a retention agreement dated August 20, 2024. She has been engaged as an invalidity and claim construction expert at a rate of $750 per hour. Draft expert reports, preliminary analyses, and all communications between counsel and Dr. Ostrowski are protected under Fed. R. Civ. P. 26(b)(4)(B)–(C), which shields drafts of expert reports and communications between counsel and testifying experts (with narrow exceptions for compensation and facts/data considered).
• Dr. Elena Marchetti / Pinnacle Economics Group LLC — Although not yet formally retained as of the date of this memorandum, Dr. Marchetti is anticipated to be retained as a damages expert (expected retention date: on or about November 15, 2024) at a rate of $850 per hour. Upon retention, the same protections will apply to her draft materials and communications with counsel. Reviewers should be aware of this anticipated engagement and should flag any early-stage correspondence regarding damages expert selection for appropriate coding.
• Ridgeline IP Analytics LLC (Dr. Arthur Gaines) — Ridgeline was engaged by Calderwood & Harkness LLP to prepare a confidential patent portfolio valuation for settlement purposes. Dr. Gaines and Ridgeline are retained as non-testifying consulting experts; they are not expected to be called as witnesses at trial. Their work product is fully protected under Fed. R. Civ. P. 26(b)(4)(D), and no showing of exceptional circumstances has been made or is anticipated. All materials generated by Ridgeline, including draft and final valuation reports, underlying data analyses, and communications with counsel, should be coded as PRIV-WP or PRIV-AC/WP, as appropriate.
All draft expert materials and attorney-expert communications should be coded with heightened care, and reviewers must ensure that no draft expert reports, preliminary expert analyses, or attorney memoranda reflecting expert opinions are inadvertently included in the production set. Any questions regarding the scope of expert-related protections should be directed to Christy Bauer.
C. Common Interest / Joint Defense Considerations
Communications between Calderwood & Harkness LLP and Kendrick & Lau LLP are subject to the common interest privilege (sometimes referred to as the "joint defense privilege" or "allied party doctrine") where both firms are working in furtherance of a shared legal interest. In this matter, the shared legal interest encompasses the defense of the patent infringement claims asserted by Apex, as well as the related patent prosecution analysis and freedom-to-operate assessment conducted by K&L on behalf of Solstice.
The common interest privilege extends the attorney-client privilege to communications between attorneys representing different clients (or, as here, between co-counsel representing the same client under separate engagements) who share a common legal interest, provided that the communications are made in furtherance of that shared interest and are otherwise confidential. This protection is particularly relevant to communications between Calderwood & Harkness LLP attorneys and Dr. Jonathan Kendrick of K&L regarding claim construction, prior art analysis, and FTO opinions bearing on the defense of the asserted patents.
Any documents for which the common interest privilege is asserted should be logged with a clear notation indicating the common interest basis for the privilege claim. The privilege log entry should identify the participating attorneys and firms, the nature of the shared legal interest, and the fact that the communication was made in furtherance of that interest. Documents coded as PRIV-CI should also be reviewed during second-pass to confirm the applicability of the common interest doctrine to the specific communication.
D. Insurance Communications
Communications with Halcyon Specialty Insurance Co. ("Halcyon") regarding coverage of defense fees and costs in this litigation present distinct privilege considerations. Halcyon provides intellectual property litigation insurance to Solstice under Policy No. HSI-IP-2023-04891. The designated claims adjuster is Sandra Keene. The policy provides a per-occurrence limit of $5,000,000 and an aggregate limit of $10,000,000, with a $250,000 self-insured retention ("SIR"). Solstice has tendered the defense of this action to Halcyon, and coverage has been acknowledged subject to a reservation of rights.
Communications between Solstice (including its counsel) and Halcyon may be subject to the attorney-client privilege or the work product doctrine depending on the nature and content of the communications. In particular:
• Communications in which Solstice or its counsel seeks coverage-related legal advice from Halcyon's coverage counsel, or in which Halcyon's counsel provides such advice, may be privileged.
• Communications in which Solstice's counsel provides litigation updates to Halcyon in connection with the defense of the insured claim may be privileged to the extent they reflect or communicate legal analysis, strategy, or mental impressions.
• Routine administrative communications regarding billing submissions, invoice processing, and SIR status are less likely to be privileged but should nonetheless be reviewed carefully.
• Communications discussing coverage terms, policy interpretation, and defense strategy are likely privileged and should be withheld from production.
Given the complexity of insurance-related privilege issues and the potential for disputes regarding the scope of the insurer's alignment with the insured, all Halcyon-related communications must be flagged as PRIV-INS during first-pass review and escalated to Christy Bauer or Marcus Delgado for second-pass determination. No Halcyon-related document should be produced without express approval from one of those attorneys.
III. Key Custodians and Document Sources
The following section identifies the key custodians and document sources from which privileged and potentially privileged materials are expected to be drawn. Reviewers should pay particular attention to documents from these custodians and repositories, as they are most likely to contain attorney-client communications, work product, and other protected materials.
A. Priority Custodians
The following individuals have been identified as priority custodians whose files are most likely to contain privileged or work-product-protected documents. Reviewers should apply heightened scrutiny to all documents from these custodians:
1. Eamon Rourke, General Counsel, Solstice Biomedical Devices Ltd. (Dublin, Ireland) — Mr. Rourke's custodial files include all email correspondence, internal memoranda, files, and correspondence exchanged with outside counsel at Calderwood & Harkness LLP and Kendrick & Lau LLP. As General Counsel, Mr. Rourke is the primary conduit for legal advice within the Solstice corporate structure, and the vast majority of his communications with outside counsel will be privileged. Reviewers should also be attentive to communications in which Mr. Rourke transmits legal advice from outside counsel to other Solstice personnel; these remain privileged so long as the communication was made in confidence and for the purpose of conveying legal advice.
2. Niamh Cassidy, Vice President, Regulatory & intellectual Property, Solstice Biomedical, Inc. (Wilmington, DE) — Ms. Cassidy's files include communications with Calderwood & Harkness LLP and Kendrick & Lau LLP regarding the PrecisionEdge™ product line, IP strategy, the patent landscape in the surgical trocar space, and analysis of the asserted patents. Ms. Cassidy's dual role in regulatory affairs and IP management means that her files will contain a substantial volume of dual-purpose documents requiring careful application of the primary purpose test. Documents in which Ms. Cassidy communicates with counsel regarding legal analysis of patent claims, infringement risk, or litigation strategy should be coded as privileged. Documents in which she communicates with engineering or regulatory personnel about product specifications, regulatory submissions, or commercial matters—even if they reference patents or IP—should be evaluated individually to determine whether the primary purpose is legal or business.
3. Dr. Fiona Tierney, Chief Executive Officer, Solstice Biomedical Devices Ltd. (Dublin, Ireland) — Dr. Tierney's custodial files include board-level communications regarding litigation strategy, settlement authority, legal risk assessment, and the financial and operational implications of the litigation. Communications between Dr. Tierney and counsel (whether in-house or outside) that seek or provide legal advice are privileged. Board presentations and memoranda prepared for Dr. Tierney's review regarding the litigation are likely to contain privileged content, particularly where they reflect or communicate legal analysis or strategy. All documents from Dr. Tierney's files that are coded as privileged must be reviewed by Marcus Delgado during second-pass review.
4. Brendan Molloy, Chief Financial Officer, Solstice Biomedical, Inc. (Wilmington, DE) — Mr. Molloy's files include financial analyses prepared at the direction of counsel in connection with the litigation, including data compilations and projections bearing on damages exposure. His files also include correspondence with Halcyon Specialty Insurance Co. regarding coverage of defense costs, premium and SIR status, and related financial matters. Financial analyses prepared at counsel's direction for litigation purposes are protected work product; insurance-related communications should be coded PRIV-INS and escalated as described in Section II.D above.
5. R&D and Engineering Personnel — Certain members of Solstice's research and development and engineering teams who were involved in the design, development, and testing of the PE-5000, PE-12000, and PE-15000 trocar assemblies may have communicated with counsel regarding design features, claim charts, technical comparisons, and infringement or invalidity analysis. These individuals include, but are not limited to, members of the PrecisionEdge™ development team in both the Dublin and Wilmington facilities. Communications between R&D/engineering personnel and counsel (or communications among such personnel at the direction of counsel) may be privileged to the extent they were made for the purpose of obtaining or providing legal advice or were prepared in anticipation of litigation.
B. Corporate Repositories
In addition to individual custodian files, the following corporate repositories have been identified as sources likely to contain privileged or work-product-protected materials:
• Solstice Legal Department Shared Drive (Dublin and Wilmington) — The legal department maintains shared network drives at both the Dublin headquarters of Solstice Biomedical Devices Ltd. and the Wilmington offices of Solstice Biomedical, Inc. These drives contain legal memoranda, outside counsel correspondence, litigation files, contract drafts, IP prosecution files, and other materials generated or maintained by the legal department. A substantial portion of these materials is expected to be privileged.
• Board and Committee Meeting Materials — Board of Directors meeting minutes, presentations, and related materials where litigation, IP strategy, or legal risk matters were discussed are maintained in the corporate secretary's files and on the board portal. These materials are privileged to the extent they reflect or communicate legal advice, as discussed further in Section VII.B below.
• Kendrick & Lau LLP Prior Art Search Files and FTO Analysis Materials — K&L has conducted extensive prior art searches and prepared FTO analyses for Solstice regarding the PrecisionEdge™ product line and the asserted patents. K&L's fees to date total approximately $184,500, billed under a separate engagement agreement. The original files are housed at K&L's offices at 601 Pennsylvania Avenue NW, Suite 820, Washington, DC 20004; however, copies of certain K&L materials—including final and draft FTO opinions, prior art compilations, and related correspondence—may reside in Solstice's systems, including on the legal department shared drive and in the email files of Eamon Rourke and Niamh Cassidy. All such materials are protected work product and/or attorney-client privileged communications and must be withheld from production.
C. Third-Party Vendor Files
The following third-party vendors have generated or hold materials that may be subject to privilege or work product protection:
• DataVault Litigation Solutions, LLC — DataVault's review platform contains the processed ESI, reviewer coding decisions, analytics outputs, and predictive coding models used in the TAR process. While the underlying platform data and review analytics are generally attorney work product (prepared in anticipation of litigation by agents of the party), certain DataVault outputs—such as de-duplication logs and processing reports—may not be privileged. Reviewers should consult with Christy Bauer before producing any DataVault-generated materials.
• Ridgeline IP Analytics LLC — All materials generated by Ridgeline in connection with the confidential patent portfolio valuation—including draft and final reports, underlying data, communications with Dr. Arthur Gaines, and any related correspondence—are protected work product. As noted in Section II.B above, Ridgeline was retained as a non-testifying consulting expert, and its materials are fully shielded from discovery.
IV. Review Workflow and Coding Instructions
A. First-Pass Review
The first-pass privilege review is conducted within the DataVault platform by contract reviewers managed through DataVault and by Calderwood & Harkness LLP associates assigned to this matter. The first-pass review is designed to identify and code all documents that are potentially subject to attorney-client privilege, work product protection, or any other applicable privilege or immunity. The first-pass review occurs concurrently with the responsiveness review under the TAR protocol; documents that are identified as both responsive and potentially privileged are routed into the privilege review queue for coding.
During first-pass review, each document identified as potentially privileged must be coded with one of the following privilege designations in the DataVault coding panel. Reviewers should select the designation that most accurately reflects the basis for the privilege claim. Where multiple privileges apply, the dual or combined designation should be used.
Reviewers must apply these codes thoughtfully and must not default to REVIEW-QC as a means of avoiding difficult privilege determinations. The REVIEW-QC code should be reserved for genuinely ambiguous situations—such as dual-purpose communications where the primary purpose is unclear, documents involving Niamh Cassidy's mixed-function role, or communications that may or may not have been made in confidence. Where the privilege determination is reasonably clear, the reviewer should apply the appropriate PRIV code and proceed.
In addition to selecting the privilege code, first-pass reviewers must populate the following metadata fields in the DataVault coding panel for every document coded with any PRIV designation:
• Author/Sender
• Recipient(s) (To, CC, BCC)
• Date
• Document type (email, memorandum, letter, presentation, spreadsheet, etc.)
• Brief description of the privilege basis (a concise, non-privileged statement explaining why the document is privileged—this field will be used to generate the privilege log entries)
B. Second-Pass Review
The second-pass review is conducted by Peter Vassiliev and Christy Bauer for all documents coded with any PRIV subcategory (PRIV-AC, PRIV-WP, PRIV-OWP, PRIV-AC/WP, PRIV-CI, PRIV-INS, PRIV-EXPERT) and all documents coded REVIEW-QC. The purpose of the second-pass review is to verify the accuracy of the first-pass privilege coding, ensure consistency across reviewers, refine privilege log descriptions, and resolve ambiguous privilege calls.
The following escalation tiers apply during second-pass review:
• Peter Vassiliev reviews all PRIV-coded documents and REVIEW-QC documents as an initial quality check, confirming or modifying the first-pass coding and privilege log descriptions. Peter may resolve straightforward privilege calls independently and should escalate complex or sensitive issues to Christy Bauer.
• Christy Bauer reviews all documents escalated by Peter, all PRIV-INS documents (insurance-related), all documents involving Niamh Cassidy where the dual-purpose analysis is required, and any documents presenting novel or complex privilege issues. Christy has final authority on all privilege determinations except those involving CEO or Board-level communications, settlement-related materials, or insurance coverage strategy, which are reserved for Marcus Delgado.
• Marcus Delgado reviews and has final authority on all documents involving Dr. Fiona Tierney (CEO) or Board-level communications, all settlement-related materials, all documents involving insurance coverage strategy or communications with Halcyon regarding coverage terms and defense obligations, and any other documents that Christy Bauer or Peter Vassiliev determine require Partner-level review.
Special attention must be given to documents involving Niamh Cassidy, whose role as Vice President, Regulatory & intellectual Property straddles legal and business functions. As noted in Section II.A above, the dual-purpose analysis requires an assessment of whether the primary purpose of each communication was to seek or provide legal advice. For documents involving Ms. Cassidy, the second-pass reviewer should consider the following factors:
• Was the communication directed to or from counsel (in-house or outside)?
• Does the communication request or provide legal analysis, as opposed to business or regulatory guidance?
• Is the communication part of a thread or series that is predominantly legal in nature?
• Would the communication have been made in substantially the same form absent the need for legal advice?
C. Redaction Protocol
Where a document contains both privileged and non-privileged content, partial redaction is permitted to allow production of the non-privileged portions while protecting the privileged content. This approach is preferred over wholesale withholding where it is practicable and does not risk disclosure of privileged material through context or inference.
The following guidelines govern the redaction process:
1. Redacted documents must be produced with clear, visible redaction markings (black boxes or bars over the redacted text) that do not obscure the surrounding non-privileged content.
2. Each redaction must be accompanied by a notation on the face of the document or in a redaction legend indicating the basis for the redaction (e.g., "REDACTED — Attorney-Client Privilege" or "REDACTED — Attorney Work Product").
3. A corresponding entry must be made on the privilege log for each redacted document, identifying the Bates number(s) of the redacted document, the nature and basis of the redaction, and sufficient descriptive information to permit Apex and the Court to evaluate the privilege claim.
4. All redactions must be reviewed and approved by Christy Bauer or Marcus Delgado before the redacted document is included in the production set. No redacted document may be produced without such approval.
5. Redactions must be applied to the native or near-native production format using the redaction tools within the DataVault platform. Reviewers should not attempt manual redactions outside the platform.
V. Privilege Log Format and Required Fields
A. Log Format
The privilege log will be maintained in a Ashbury Holdings Excel spreadsheet format, with a separate row for each document or communication that is withheld in full or produced in redacted form on the basis of privilege or work product protection. The spreadsheet will contain the following columns:
The completed privilege log will be exported from the DataVault platform using the privilege log report template configured by DataVault's project management team. Peter Vassiliev and Christy Bauer will review the exported log for completeness, accuracy, and consistency before finalization and service.
B. Description Guidelines
The descriptions entered in the "Subject / Description" column of the privilege log are critically important. They must be sufficiently specific to permit Apex and the Court to evaluate the validity of the privilege claim on a document-by-document basis, without revealing the substance of the privileged communication or protected work product. The following guidelines govern the drafting of privilege log descriptions:
1. Specificity. Each log entry must be tailored to the specific document. Boilerplate or generic descriptions are unacceptable and may result in a finding that the privilege log is deficient, potentially leading to waiver or an order to produce. Reviewers must describe the general subject matter of the communication (e.g., "claim construction strategy," "infringement analysis," "prior art search," "litigation budget") without revealing the substance of the legal advice or attorney mental impressions.
2. Avoid Disclosure of Privileged Content. Descriptions must not disclose the substance of legal advice, the content of attorney mental impressions or legal theories, or the specific conclusions or recommendations of counsel. The description should convey the topic of the communication, not its content.
3. Identify Participants and Their Roles. The log should clearly identify the author/sender and recipient(s) by name, title, and organizational affiliation. Where a participant is an attorney, the log should identify the individual as counsel and note the firm or entity affiliation.
4. State the Nature of the Communication. The description should indicate whether the communication involves a request for legal advice, the provision of legal advice, the transmission of information to counsel for the purpose of obtaining legal advice, or the preparation of materials in anticipation of litigation.
The following examples illustrate acceptable and unacceptable privilege log descriptions:
Acceptable Example:
"Email from Eamon Rourke (General Counsel, Solstice Biomedical Devices Ltd.) to Marcus Delgado (Partner, Calderwood & Harkness LLP) requesting legal advice regarding claim construction strategy for U.S. Patent No. 9,814,237 in connection with Apex Surgical Innovations, Inc. v. Solstice Biomedical, Inc., Case No. 1:24-cv-00587-RGA."
Acceptable Example:
"Memorandum prepared by Christy Bauer (Associate, Calderwood & Harkness LLP) analyzing prior art references identified during invalidity investigation for U.S. Patent No. 10,271,884, prepared in anticipation of litigation."
Unacceptable Example:
"Email about patent case." — This description is too vague to permit meaningful evaluation of the privilege claim. It does not identify the participants, the specific subject matter, or the nature of the communication.
Unacceptable Example:
"Email discussing weakness in Apex's claim 1 argument and Solstice's likely defenses." — This description reveals the substance of attorney mental impressions and legal analysis, thereby risking waiver of the very privilege it purports to assert.
Reviewers should model their descriptions on the acceptable examples above and exercise judgment in describing each document with sufficient specificity to satisfy the log's function without compromising the privilege. Christy Bauer and Peter Vassiliev will review all log descriptions during second-pass review and will revise entries that are too vague, too revealing, or inconsistent with these guidelines.
VI. Clawback and Inadvertent Production
A. Fed. R. Evid. 502(b) and (d) Protections
The parties in this action are expected to enter into (or have entered into) a Confidentiality and Protective Order that includes provisions governing the treatment of inadvertently produced privileged materials. The Protective Order should include a provision pursuant to 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, regardless of whether the disclosure was inadvertent. A Rule 502(d) order provides the most robust protection against inadvertent waiver and is binding on all parties and non-parties in the litigation, as well as in other federal and state proceedings.
In the event that a Rule 502(d) order is entered, inadvertent production of a privileged document will not constitute a waiver of the privilege, provided that the producing party takes reasonable steps to rectify the error promptly upon discovery.
In addition, Federal Rule of Evidence 502(b) provides a statutory framework for evaluating inadvertent waiver in the absence of a court order. Under Rule 502(b), inadvertent disclosure of privileged material does not operate as a waiver if:
(1) the disclosure was inadvertent;
(2) the holder of the privilege took reasonable steps to prevent disclosure; and
(3) the holder promptly took reasonable steps to rectify the error, including, if applicable, following the procedures set forth in Federal Rule of Civil Procedure 26(b)(5)(B).
Adherence to this privilege review protocol—including the multi-tier review process, quality control audits, and the coding and logging procedures described herein—constitutes evidence of "reasonable steps to prevent disclosure" for purposes of Rule 502(b).
Internal Clawback Process. In the event that a reviewer or any member of the litigation team identifies a potentially privileged document that may have been inadvertently produced to Apex, the following steps must be taken immediately:
1. The identifying individual must immediately notify Christy Bauer by email and telephone, providing the Bates number(s) of the document, a brief description of the document, and the basis for the belief that the document is privileged.
2. Christy Bauer will promptly review the document and, if she concurs that the document is or may be privileged, will escalate the matter to Marcus Delgado for a final determination.
3. Upon confirmation that the document is privileged, Marcus Delgado (or his designee) will issue a formal clawback demand to Apex's counsel pursuant to Fed. R. Civ. P. 26(b)(5)(B) and the applicable provisions of the Protective Order. The demand will identify the document, assert the applicable privilege, and request that Apex return, sequester, or destroy all copies of the document and refrain from using the document or its contents in the litigation.
4. The clawback demand should be made as promptly as practicable—ideally within 48 hours of identification of the inadvertent production, and in no event later than five business days absent exigent circumstances.
5. The document will be added to the privilege log with an appropriate notation that it was inadvertently produced and subsequently clawed back.
B. Quick-Peek Provisions
If the Joint discovery Plan or ESI protocol in this matter includes any "quick-peek" provisions—i.e., provisions permitting the receiving party to review documents before the producing party has completed its privilege review—production under such provisions does not constitute a waiver of any privilege or protection. Documents produced pursuant to a quick-peek arrangement remain subject to later privilege review and withholding, and the producing party retains the right to assert privilege over any such document upon completion of its review.
As of the date of this memorandum, no quick-peek provision has been agreed to or ordered in this matter. If such a provision is adopted in the future, this protocol will be supplemented to address the specific procedures applicable to quick-peek productions.
VII. Special Categories Requiring Heightened Attention
Certain categories of documents present elevated privilege risks or require specialized analysis. Reviewers must exercise heightened scrutiny when reviewing documents falling into any of the following categories and should not hesitate to escalate ambiguous or borderline documents to second-pass review using the REVIEW-QC code.
A. Pre-Suit Communications
Any communications between Solstice and Apex (including through their respective counsel) prior to the May 9, 2024 filing of the Complaint require careful review. These pre-suit communications include, but are not limited to:
• Cease-and-desist correspondence from Apex to Solstice (and any responses from Solstice or its counsel) placing Solstice on notice of the alleged infringement of the '237, '884, and '105 Patents.
• Pre-suit licensing discussions or negotiations between the parties or their representatives, to the extent such discussions occurred.
• Internal Solstice communications analyzing the cease-and-desist letter and evaluating the legal risks and potential responses.
Pre-suit legal memoranda regarding freedom-to-operate for the PrecisionEdge™ product line are likely to have been prepared by Kendrick & Lau LLP (Dr. Jonathan Kendrick) and constitute attorney work product prepared in anticipation of this specifically threatened litigation. These documents are among the most sensitive in the collection and are likely to be the subject of aggressive discovery efforts by Apex.
Particular care is required because these pre-suit communications may be highly relevant to Apex's discovery requests—including requests seeking information about Solstice's knowledge of the asserted patents, its pre-suit analysis of infringement risk, and its decision to proceed with the PrecisionEdge™ product launch—but are simultaneously among the most strongly privileged documents in the collection. Reviewers must ensure that the privilege is asserted accurately and that the log entries for these documents are sufficiently detailed to withstand challenge.
B. Board and Executive Communications
Board of Directors presentations, minutes, and related materials discussing the patent infringement risk, litigation budget, legal strategy, settlement authority, and defense posture are privileged to the extent they reflect or communicate legal advice from counsel (whether in-house or outside). The following guidelines apply:
• Board minutes that contain a summary of legal advice provided by Eamon Rourke or outside counsel regarding the litigation are privileged in their entirety if the legal discussion constitutes the primary purpose of the relevant portion of the minutes. Where the minutes address both legal and business matters, redaction of the privileged portions may be appropriate.
• Presentations prepared by counsel for the Board regarding litigation strategy, exposure analysis, or settlement options are attorney work product (and may also be privileged attorney-client communications).
• Communications among executive officers (Dr. Tierney, Mr. Rourke, Ms. Cassidy, Mr. Molloy) regarding the litigation are privileged where they involve the seeking or provision of legal advice. Communications that are purely business-related—such as discussions of product strategy, market impact, or financial performance unrelated to the litigation—are not privileged merely because they are exchanged among executives who are also involved in the litigation.
All documents from Dr. Fiona Tierney's custodial files that are coded as privileged, as well as all Board-level materials, must be reviewed by Marcus Delgado during second-pass review.
C. Patent Prosecution Files
The prosecution histories of Solstice's own patents are generally not privileged, as they consist of publicly available documents filed with the United States Patent and Trademark Office. However, the following materials related to patent prosecution are protected:
• Kendrick & Lau LLP's analysis of Apex's prosecution history for the '237, '884, and '105 Patents — These analyses constitute attorney work product prepared in anticipation of litigation or in furtherance of the defense of this action, reflecting counsel's legal analysis of the prosecution record and its implications for claim construction, infringement, and validity.
• FTO opinions prepared by K&L for Solstice regarding the PrecisionEdge™ product line — These opinions are attorney-client communications (to the extent they constitute legal advice provided to the client) and attorney work product (to the extent they reflect counsel's analysis of infringement risk).
• Drafts of prior art search reports and invalidity analyses prepared by K&L — These drafts are attorney work product. Even where a final version of a report has been or will be disclosed (e.g., as part of expert disclosures), draft versions and interim analyses remain protected.
Reviewers should distinguish between publicly available prosecution history documents (which are not privileged and should be produced if responsive) and K&L's proprietary analysis of those documents (which is protected). The mere fact that a document references a patent prosecution history does not render it privileged; conversely, the fact that a document is based on publicly available information does not strip it of work product protection if it reflects counsel's selection, compilation, or analysis of that information.
D. Expert Communications
As of the date of this memorandum, the following experts have been or are anticipated to be retained in connection with this litigation:
• Dr. Miriam Ostrowski (Halford University, Department of Mechanical Engineering) — Retained by Calderwood & Harkness LLP on behalf of Solstice pursuant to a retention agreement dated August 20, 2024, for invalidity and claim construction expert work at a rate of $750 per hour. Dr. Ostrowski is expected to serve as a testifying expert. All communications between counsel and Dr. Ostrowski, draft expert reports, preliminary analyses, and attorney notes reflecting expert analysis are protected under Fed. R. Civ. P. 26(b)(4)(B)–(C). The narrow exceptions to this protection—for facts or data considered by the expert and for the expert's compensation—do not require production of draft reports or attorney-expert communications.
• Dr. Elena Marchetti / Pinnacle Economics Group LLC — Anticipated to be retained as a damages expert on or about November 15, 2024, at a rate of $850 per hour. Although Dr. Marchetti has not yet been formally retained as of this memorandum's date, reviewers should be aware of this anticipated engagement and should flag any preliminary communications regarding damages expert selection or damages methodology for appropriate coding upon Dr. Marchetti's formal retention.
• Ridgeline IP Analytics LLC (Dr. Arthur Gaines) — Ridgeline was engaged by Calderwood & Harkness LLP to prepare a confidential patent portfolio valuation for settlement purposes. Dr. Gaines and Ridgeline are retained as non-testifying consulting experts and are not expected to testify at trial. Their work product is fully protected under Fed. R. Civ. P. 26(b)(4)(D). All materials generated by Ridgeline—including draft and final valuation reports, data analyses, communications with counsel, and invoices reflecting the scope or substance of the engagement—should be withheld from production and logged as PRIV-EXPERT or PRIV-WP.
E. Insurance File
All communications with Halcyon Specialty Insurance Co., its claims adjuster Sandra Keene, and its coverage counsel require individualized review and are subject to the insurance-related privilege considerations discussed in Section II.D above. The following specific documents and categories of documents should be reviewed with particular care:
• Coverage Notification Letter (dated May 13, 2024) — Solstice's initial notification to Halcyon of the filing of the Complaint, tendering the defense of the action under Policy No. HSI-IP-2023-04891.
• Coverage Acknowledgment and Reservation of Rights Letter from Halcyon — Halcyon's response acknowledging coverage subject to a reservation of rights. The substance of this letter was summarized in an internal memorandum dated June 3, 2024, which is itself likely privileged.
• Ongoing Communications with Sandra Keene — Communications regarding billing submissions, invoice approvals, SIR status, and defense cost management, as well as any communications regarding coverage disputes, policy interpretation, or defense strategy.
All Halcyon-related communications must be coded PRIV-INS during first-pass review and escalated to Christy Bauer or Marcus Delgado for second-pass determination. Given the sensitivity of these communications and the potential for disputes regarding the insurer's alignment with the insured, no insurance-related document should be produced or excluded from the privilege log without express approval from Christy Bauer or Marcus Delgado.
F. Settlement-Related Communications
While settlement negotiations are in their earliest stages (if they have commenced at all as of this memorandum's date), any documents referencing settlement, compromise, resolution, or related topics must be flagged for heightened review. Settlement-related communications are protected on multiple grounds:
• Attorney-Client Privilege: Communications between Solstice and its counsel discussing settlement strategy, settlement authority, or settlement terms constitute confidential attorney-client communications made for the purpose of obtaining legal advice.
• Attorney Work Product: Analyses of settlement value, litigation risk, and potential settlement structures prepared by counsel in anticipation of litigation constitute work product.
• Federal Rule of Evidence 408: Evidence of conduct or statements made during compromise negotiations is not admissible to prove the validity or amount of a disputed claim. While Rule 408 is an evidentiary rule rather than a privilege, it provides an independent basis for withholding settlement-related communications from discovery in many circumstances.
Any documents referencing settlement, compromise, resolution, or mediation—including internal Solstice communications discussing settlement authority or parameters—should be flagged as REVIEW-QC or coded PRIV-AC/WP and escalated to Marcus Delgado for review during the second-pass process.
VIII. Quality Control and Audit Procedures
Robust quality control is essential to the integrity of the privilege review and the defensibility of the privilege log. The following quality control and audit procedures will be implemented throughout the review process:
Random QC Sampling. Peter Vassiliev will conduct a random quality control audit of all first-pass privilege coding decisions, sampling no fewer than 5% of all documents coded during first-pass review (including both PRIV-coded and NON-PRIV-coded documents). The QC sample will be drawn at random by the DataVault platform using a stratified sampling methodology to ensure representation across custodians, document types, and privilege codes. The results of each QC sampling round will be documented and retained in the matter file. If the QC audit reveals an error rate exceeding 5% for any reviewer or batch, additional training will be provided and the affected documents will be re-reviewed.
Consistency Checks. DataVault will run automated consistency checks to identify facially similar documents—including near-duplicate emails, thread families, and documents with overlapping metadata—that have received inconsistent privilege coding. For example, if an email in a thread is coded PRIV-AC but a subsequent email in the same thread containing the original message is coded NON-PRIV, the consistency check will flag this discrepancy for manual review and resolution. Peter Vassiliev and Christy Bauer will review all flagged inconsistencies and make final coding determinations.
Deadline Management. The privilege log must be substantially complete by September 25, 2024—five calendar days before the targeted September 30, 2024 document production date—to allow sufficient time for final review by Marcus Delgado, correction of any deficiencies, and preparation of the log for service. Intermediate milestones are as follows:
• September 9, 2024: First-pass privilege review to be completed for all documents in the initial production set (Bates Nos. SBD-000001 through SBD-048217).
• September 16, 2024: Second-pass review to be completed for all PRIV-coded and REVIEW-QC documents. Random QC audit to be completed.
• September 20, 2024: Privilege log draft (Excel format) to be generated from the DataVault platform and circulated to Christy Bauer for review.
• September 25, 2024: Final privilege log to be submitted to Marcus Delgado for review and approval.
• September 30, 2024: Document production and privilege log served on Apex's counsel.
The privilege log will be served simultaneously with, or promptly after, the document production on September 30, 2024, in accordance with the requirements of Federal Rule of Civil Procedure 26(b)(5)(A) and the Local Rules of the District of Delaware.
IX. Supplementation and Ongoing Obligations
The privilege log is a living document and must be supplemented as additional responsive documents are identified, as new privilege issues arise during the course of discovery, or as additional productions are made. Solstice's discovery obligations are ongoing, and the privilege log must be updated to reflect any changes to the document production or to the privilege designations assigned to previously reviewed documents.
Specifically, the following circumstances will trigger supplementation of the privilege log:
• Additional Document Productions: Solstice's Second Set of Requests for Production is anticipated for mid-October 2024, and Apex is expected to serve additional discovery requests as the case progresses. Any documents produced in subsequent productions—beyond Bates No. SBD-048217—will be subject to the same privilege review protocol set forth in this memorandum, and any withheld or redacted documents will be added to the privilege log.
• Newly Identified Documents: If additional responsive documents are identified in supplemental custodian collections, newly identified repositories, or through other means, those documents will be reviewed for privilege and logged as appropriate.