CALDERWOOD & HARKNESS LLP Attorneys at Law
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PRIVILEGED AND CONFIDENTIAL ATTORNEY-CLIENT COMMUNICATION / ATTORNEY WORK PRODUCT
May 11, 2024
TO: All Identified Custodians of Solstice Biomedical Devices Ltd. and Solstice Biomedical, Inc.
FROM: Marcus Delgado, Responsible Partner, intellectual Property, Calderwood & Harkness LLP; and Christy Bauer, Lead Associate, intellectual Property, Calderwood & Harkness LLP
CC: Eamon Rourke, General Counsel, Solstice Biomedical Devices Ltd.; Niamh Cassidy, VP, Regulatory & IP, Solstice Biomedical Devices Ltd.
RE: LITIGATION HOLD NOTICE — Apex Surgical Innovations, Inc. v. Solstice Biomedical, Inc., Case No. 1:24-cv-00587-RGA, U.S. District Court for the District of Delaware
Matter No.: 10294.0017
DATE: May 11, 2024
LITIGATION HOLD NOTICE IMMEDIATE ACTION REQUIRED — PLEASE READ IN ITS ENTIRETY
1. Purpose and Legal Obligation
Calderwood & Harkness LLP has been retained by Solstice Biomedical Devices Ltd. ("Solstice" or "SBD") and its U.S. operating subsidiary, Solstice Biomedical, Inc. ("Solstice US," and together with Solstice, the "Company"), to defend a patent infringement action filed by Apex Surgical Innovations, Inc. ("Apex") in the United States District Court for the District of Delaware. The complaint in this action, captioned Apex Surgical Innovations, Inc. v. Solstice Biomedical, Inc., Case No. 1:24-cv-00587-RGA (the "Action" or "Litigation"), was filed on May 9, 2024 and is pending before Chief Judge Richard G. Andrews. The Company anticipates being served with the summons and complaint through its registered agent, Pemberton Industries, located in Wilmington, Delaware, in the near future. Although formal service has not yet been effected as of the date of this notice, this litigation hold is being issued proactively in anticipation of service, which we expect to occur on or about May 23, 2024, in order to ensure that the Company's preservation obligations are satisfied at the earliest possible date.
This notice constitutes a legal hold directive that requires the immediate preservation of all potentially relevant documents, electronically stored information ("ESI"), and tangible materials in connection with the Action. You are receiving this notice because you have been identified as a custodian — that is, a person who may possess, have access to, or have control over documents, data, or information that could be relevant to the claims and defenses in the Action.
Federal law, the Federal Rules of Civil Procedure, and the local rules of the United States District Court for the District of Delaware impose a duty on all parties and their representatives to preserve evidence that is relevant to pending or reasonably anticipated litigation. This obligation to preserve attaches as soon as a party knows or reasonably should know that litigation is likely. In the present case, the Company's preservation obligation arose no later than the date of this notice. Failure to preserve relevant evidence can result in serious court-imposed sanctions, including but not limited to:
• Adverse inference instructions to the jury (permitting or requiring the jury to infer that destroyed or lost evidence was unfavorable to the Company);
• Monetary penalties and fee-shifting;
• Preclusion of evidence or testimony;
• Default judgment or dismissal of affirmative claims or defenses; and
• Other remedial measures deemed appropriate by the Court under Federal Rule of Civil Procedure 37(e) and the inherent powers of the Court.
This litigation hold obligation supersedes and takes priority over any document retention or destruction policies, automatic deletion schedules, routine purging protocols, or other information-management practices currently in effect at Solstice Biomedical Devices Ltd. or Solstice Biomedical, Inc. Notwithstanding any such policies, you must immediately cease the destruction, deletion, alteration, or disposal of any documents, ESI, or tangible materials that fall within the scope of this hold, as described in detail below. This obligation applies regardless of the format in which the information exists, the system or medium on which it is stored, or the physical location where it is maintained.
Your full cooperation with the requirements of this litigation hold is essential to the Company's defense of the Action. Please read this notice carefully and in its entirety, and take the specific actions described herein immediately upon receipt.
2. Description of the Litigation
The plaintiff in the Action is Apex Surgical Innovations, Inc. ("Apex"), a Delaware corporation with its principal place of business at 1220 North Market Street, Suite 550, Wilmington, Delaware 19801. Apex is a medical device company engaged in the development, manufacture, and sale of surgical instruments and laparoscopic access devices.
In the complaint filed on May 9, 2024, Apex alleges that Solstice's PrecisionEdge™ line of laparoscopic trocar assemblies infringes three Apex utility patents. Specifically, Apex has asserted the following patents and claims against the Company:
2.1 Asserted Patents
U.S. Patent No. 9,814,237 (the "'237 Patent")
• Title: "Locking Seal Assembly for Minimally Invasive Surgical Access Device"
• Issue Date: November 14, 2017
• Expiration Date: June 22, 2035
• Asserted Claims: Claims 1, 3, 7, and 12
• Named Inventor: Dr. Raymond Szabo (Vice President, Engineering, Apex Surgical Innovations, Inc.)
• Assignee: Apex Surgical Innovations, Inc.
U.S. Patent No. 10,271,884 (the "'884 Patent")
• Title: "Retractable Blade Deployment Mechanism for Trocar Systems"
• Issue Date: April 30, 2019
• Expiration Date: September 15, 2036
• Asserted Claims: Claims 1, 2, 5, 9, and 14
• Named Inventor: Dr. Raymond Szabo (Vice President, Engineering, Apex Surgical Innovations, Inc.)
• Assignee: Apex Surgical Innovations, Inc.
U.S. Patent No. 10,932,105 (the "'105 Patent")
• Title: "Integrated Insufflation Valve and Seal for Laparoscopic Trocar"
• Issue Date: March 2, 2021
• Expiration Date: January 10, 2038
• Asserted Claims: Claims 1, 4, and 8
• Named Inventor: Dr. Raymond Szabo (Vice President, Engineering, Apex Surgical Innovations, Inc.)
• Assignee: Apex Surgical Innovations, Inc.
The '237, '884, and '105 Patents are collectively referred to herein as the "Asserted Patents." The Asserted Patents form part of a broader patent family (the "Apex Trocar Patent Family") that includes fourteen (14) total issued U.S. patents and six (6) pending continuation applications. While only the three Asserted Patents have been asserted in the complaint as currently filed, the remaining patents in the Apex Trocar Patent Family may become relevant to the Company's defense strategies, including invalidity and prior art analyses. Accordingly, documents relating to any patent within the Apex Trocar Patent Family should be preserved.
3. Accused Products
The following Solstice product lines have been specifically accused of infringement in the Action and are a primary focus of this litigation hold:
The PE-5000, PE-12000, and PE-15000 Series products are collectively referred to herein as the "Accused Products."
The scope of this hold is not limited to the specific product models identified by name in the complaint. The hold also extends to any successor, modified, redesigned, or next-generation versions of the Accused Products, whether currently in production, under development, or previously offered for sale. In addition, the hold extends to any other laparoscopic trocar products manufactured, developed, tested, marketed, sold, offered for sale, imported, or distributed by the Company (including products sold under different brand names or product designations) that incorporate locking-seal assembly technology, retractable blade-deployment mechanisms, insufflation-valve technology, or any other technology similar to that described in the Asserted Patents.
For purposes of damages analysis and the Company's defense, it is important to note that combined U.S. sales of the Accused PrecisionEdge™ products span calendar years 2021 through the present. Accordingly, the temporal scope of this hold extends back to at least January 1, 2019 (to capture pre-launch development activities, as well as the full period of accused commercial activity) and continues through the present and for the duration of the Litigation.
4. Identified Custodians
The following individuals and functional groups have been identified as custodians whose files, records, communications, and other materials are subject to this litigation hold. If you are identified below — either by name or by functional role — you are a custodian subject to the obligations set forth in this notice. This list may be supplemented as the Litigation progresses and additional custodians are identified. If you receive a supplemental hold notice identifying you as a custodian, the obligations described herein will apply to you with equal force.
4.1 Executive & Legal
• Dr. Fiona Tierney — Chief Executive Officer, Solstice Biomedical Devices Ltd.
• Eamon Rourke — General Counsel, Solstice Biomedical Devices Ltd.
• Brendan Molloy — Chief Financial Officer, Solstice Biomedical Devices Ltd.
4.2 Regulatory & intellectual Property
• Niamh Cassidy — Vice President, Regulatory & IP, Solstice Biomedical Devices Ltd. Ms. Cassidy serves as the primary custodian for patent-related documents, freedom-to-operate analyses, regulatory submissions, intellectual property correspondence, and related materials. Ms. Cassidy will work with outside counsel to coordinate the identification of additional custodians within the Regulatory and IP function.
4.3 Engineering, Research & Development, and Product Development
All engineers, product managers, research scientists, and research and development personnel who have been involved in the design, development, testing, prototyping, or modification of the PrecisionEdge™ PE-5000, PE-12000, and PE-15000 Series products — including, without limitation, individuals who contributed to design history files, engineering change orders, prototype testing, verification and validation activities, or design-around analyses — are custodians subject to this hold. Specific names within this group are to be identified by Eamon Rourke and Niamh Cassidy in consultation with Calderwood & Harkness LLP and will be added as supplemental custodians. Pending the identification of specific individuals, all persons who reasonably fall within this category must preserve their relevant materials.
4.4 Sales, Marketing, and Commercial Operations
All personnel responsible for U.S. sales, marketing, pricing, distribution, and commercialization of the Accused PrecisionEdge™ products are custodians subject to this hold. This includes sales representatives, regional sales managers, national account managers, marketing managers, and any other personnel who have prepared or approved marketing materials, pricing proposals, customer communications, distributor agreements, or commercial strategies for the Accused Products.
4.5 Manufacturing and Quality
All manufacturing personnel, quality assurance and quality control personnel, and supply chain and procurement personnel who have been involved in the production, assembly, inspection, packaging, or distribution of the Accused Products are custodians subject to this hold. This includes individuals responsible for device master records, device history records, batch records, quality management system documentation, supplier qualifications, incoming inspection records, and corrective and preventive action (CAPA) files related to the Accused Products.
4.6 Finance and Accounting
Personnel responsible for financial records, revenue reporting, cost accounting, margin analysis, inventory valuation, and financial forecasting for the PrecisionEdge™ product lines are custodians subject to this hold. This includes controllers, financial analysts, and accounting staff who maintain or have access to records of sales revenue, cost of goods sold, gross margins, royalty obligations, or profitability data for the Accused Products.
4.7 Information Technology and Records Management
IT personnel responsible for email systems (including Strathmore Data Systems, Ridgeline Services Inc., and any cloud-based email platforms), document management systems, enterprise content management, backup tapes, server administration, data archiving, and records retention for the identified custodians and their relevant functional groups are subject to this hold. IT personnel must take immediate steps to preserve all relevant ESI as described in Sections 6 and 7 below.
4.8 Geographic Scope
For the avoidance of doubt, personnel at both Solstice Biomedical Devices Ltd. (registered office: Unit 14, Clonskeagh Business Park, Clonskeagh Road, Dublin 14, D14 YF28, Ireland; Companies Registration Office No. 648217) and Solstice Biomedical, Inc. (registered office: 3800 Concord Pike, Suite 410, Wilmington, Delaware 19803; Employer Identification Number: 84-3291056) are covered by this litigation hold. The preservation obligation is not limited to materials physically located in the United States; it extends to all potentially relevant materials wherever they are located, including but not limited to the Company's offices in Ireland, the United States, and any other jurisdiction.
5. Categories of Documents and Information to Be Preserved
The following categories describe the types of documents, ESI, and tangible materials that must be preserved under this litigation hold. These categories are intended to be illustrative and not exhaustive. If you possess, have access to, or have control over any information that you believe may be relevant to the Litigation, you must preserve it even if it does not fall neatly within one of the categories listed below. When in doubt, preserve the material and contact one of the persons listed in Section 10.
5.1 Technical and Engineering Documents
• Design files, CAD drawings (including files in Meridian Data Systems, Glenrock Technologies, Strathmore Data Systems, and any other design software), technical specifications, schematics, bills of materials, assembly drawings, component drawings, and engineering change orders (ECOs) for the PrecisionEdge™ PE-5000, PE-12000, and PE-15000 Series products.
• Prototypes, samples, physical models, 3D-printed parts, and mock-ups of the Accused Products in all stages of development, including early-concept prototypes and production-intent samples.
• Design history files (DHFs), design input and output documents, design review meeting minutes, design verification and validation (V&V) records, risk analyses, failure mode and effects analyses (FMEAs), and any other design control documentation required by the Company's quality management system or applicable regulatory requirements.
• Technical documents specifically concerning the locking-seal assembly, retractable blade-deployment mechanism, and integrated insufflation-valve features of the Accused Products, including any design trade studies, tolerance analyses, bench testing protocols, and test reports relating to these features.
• Design-around studies, alternative design analyses, feasibility assessments, and any engineering evaluations of modifications to the Accused Products undertaken to avoid potential patent infringement.
• Freedom-to-operate analyses, right-to-practice opinions, invalidity analyses, and non-infringement analyses relating to the Accused Products or the Asserted Patents. (Note: Some of these documents may be protected by the attorney-client privilege or the work-product doctrine. Please coordinate with Eamon Rourke, Niamh Cassidy, or Calderwood & Harkness LLP before disclosing such documents to any third party, but do not destroy or delete them under any circumstances.)
• Prior art searches, patent landscape analyses, and patentability or novelty opinions relating to the technology embodied in the Accused Products.
5.2 Patent and intellectual Property Documents
• All correspondence, memoranda, opinions, presentations, and analyses relating to the '237, '884, and '105 Patents, individually or collectively, and to the broader Apex Trocar Patent Family.
• Patent prosecution files (including applications, office actions, responses, declarations, and information disclosure statements) for any Solstice patents or patent applications related to laparoscopic trocar technology, locking-seal assemblies, blade-deployment mechanisms, insufflation valves, or any other technology relevant to the Accused Products.
• Freedom-to-operate opinions, clearance analyses, infringement analyses, and invalidity analyses prepared by Kendrick & Lau LLP (601 Pennsylvania Avenue NW, Suite 820, Washington, DC 20004) or by any other patent counsel, whether internal or external, concerning the Asserted Patents or comparable trocar technology patents. (Note: As with Section 5.1 above, privilege considerations may apply; please coordinate with counsel.)
• Inventor notebooks, invention disclosures, invention assignment agreements, and prior art references collected, identified, or analyzed in connection with the design and development of the Accused Products.
• Any communications with, about, or referencing Apex Surgical Innovations, Inc., Dr. Raymond Szabo, or Apex's patents, patent applications, or patent-related activities, including without limitation any communications arising from trade shows, industry conferences, standards-setting activities, or joint ventures.
• Licensing correspondence, term sheets, and agreements (executed or proposed) relating to the Asserted Patents, any patents in the Apex Trocar Patent Family, or any third-party trocar-related patents.
5.3 Sales, Financial, and Commercial Documents
• Sales records, invoices, purchase orders, shipping records, and revenue data for the Accused PrecisionEdge™ products, both for U.S. sales and worldwide sales, covering calendar years 2021 through the present.
• Pricing information, price lists, discount schedules, rebate agreements, chargeback records, and group purchasing organization (GPO) contract pricing for the Accused Products.
• Gross margin analyses, cost of goods sold (COGS) data, standard cost sheets, manufacturing cost analyses, and profitability reports for each Accused Product line (PE-5000, PE-12000, and PE-15000 Series).
• Marketing materials, promotional literature, product brochures, sell sheets, white papers, clinical case studies, trade show materials, advertisements, digital marketing content, and website content referencing or relating to the PrecisionEdge™ PE-5000, PE-12000, and PE-15000 Series.
• Customer lists, key account summaries, distributor agreements, distribution contracts, supply agreements, and exclusive dealing arrangements for the Accused Products.
• Business plans, strategic plans, market analyses, competitive intelligence reports, sales forecasts, revenue projections, budget submissions, and annual operating plans for the PrecisionEdge™ product lines.
5.4 Regulatory Documents
• FDA 510(k) premarket notification submissions (including predicate device analyses, substantial equivalence determinations, and supporting data) for the Accused Products.
• CE marking technical documentation files, declarations of conformity, and Notified Body correspondence relating to the Accused Products.
• Any other regulatory filings, clearances, approvals, or authorizations obtained in the United States or any other jurisdiction for the Accused Products.
• Clinical data, bench testing data, animal testing data, biocompatibility studies, sterilization validation reports, shelf-life and packaging studies, and any other testing reports submitted to or prepared for regulatory agencies in connection with the Accused Products.
• Post-market surveillance reports, medical device reports (MDRs), adverse event reports, and field safety corrective actions relating to the Accused Products.
5.5 Communications
All emails, instant messages (including messages transmitted via Meridian Solutions, Northgate Data Systems, Meridian Services Inc., Harborline Technologies, or any other messaging platform), text messages (SMS and MMS), voicemails, video recordings, audio recordings, video conference recordings, chat logs, and all other forms of communication — whether internal or external, formal or informal — that reference or relate to any of the following subjects:
• The Accused PrecisionEdge™ products (PE-5000, PE-12000, and PE-15000 Series), including their design, development, testing, manufacturing, marketing, sale, distribution, and customer feedback.
• The Asserted Patents (the '237, '884, and '105 Patents) or any other patent in the Apex Trocar Patent Family.
• Apex Surgical Innovations, Inc., or any of its officers, directors, employees, agents, or representatives (including, without limitation, Dr. Raymond Szabo).
• The present Litigation, Case No. 1:24-cv-00587-RGA, or any threat, claim, demand, or discussion relating to potential or actual patent infringement assertions by Apex.
• Competitor trocar products incorporating locking-seal assembly, retractable blade-deployment, or insufflation-valve technology, including competitive benchmarking analyses, reverse engineering studies, and competitive intelligence reports.
This preservation obligation applies to communications stored on Company servers, Company-issued devices, personal devices used for business purposes (including personal smartphones, tablets, laptops, and personal email accounts), cloud-based platforms (including Crestline Software, Ashgrove Software, Larkspur Technologies, box, and Meridian Systems), collaboration tools, project management systems, and any other digital or physical repositories.
5.6 Corporate and Board Documents
• Minutes, resolutions, agendas, presentations, reports, and handouts from meetings of the Board of Directors, executive leadership team, product review committees, or IP review committees that reference or relate to the PrecisionEdge™ product line, the Asserted Patents, Apex Surgical Innovations, Inc., or this Litigation.
• Corporate governance documents, organizational charts, functional reporting structures, and employee rosters for the business units and departments involved in the design, development, manufacture, sale, or marketing of the Accused Products.
• Merger, acquisition, joint venture, or strategic partnership documentation that references or relates to the PrecisionEdge™ product line or trocar technology.
5.7 Insurance Documents
• All insurance policies that may provide coverage for the defense of intellectual property litigation or patent infringement claims, including, specifically, the policy issued by Halcyon Specialty Insurance Co. bearing Policy No. HSI-IP-2023-04891.
• All correspondence, notices of claim, reservation of rights letters, coverage opinions, and any other communications between the Company and Halcyon Specialty Insurance Co. (or any other insurer) relating to intellectual property litigation defense coverage or this Litigation specifically.
• Premium payment records, policy renewal documentation, and endorsements relating to the foregoing insurance policies.
5.8 Third-Party Communications and Contracts
• Communications and agreements with contract manufacturers, component suppliers, original equipment manufacturers (OEMs), assembly subcontractors, or any other third parties involved in the design, development, manufacture, assembly, testing, packaging, or distribution of the Accused Products.
• Licensing agreements, cross-license agreements, settlement agreements, or correspondence with any third parties concerning the Asserted Patents, the Apex Trocar Patent Family, or comparable trocar-technology patents held by any party.
• Consulting agreements, expert engagement letters, or independent contractor agreements with technical consultants, patent agents, patent attorneys, or other professionals engaged in connection with the technology embodied in the Accused Products or the Asserted Patents.
6. Scope of Preservation — ESI and Physical Media
The preservation obligations imposed by this litigation hold apply to all forms of information, whether stored in paper, electronic, magnetic, optical, or any other tangible or intangible form. The following provides additional detail on the scope of preservation for each category of media:
6.1 Electronically Stored Information (ESI)
ESI subject to preservation includes, but is not limited to:
• Emails and email attachments (including archived and deleted emails recoverable from backup systems or trash/deleted-items folders);
• Word-processing documents (Ashbury Holdings Word, Stonefield Health IT, and equivalent formats);
• Spreadsheets (Ashbury Holdings Excel, Stonefield Services Inc., and equivalent formats);
• Presentations (Ashbury Holdings Northgate Services Inc., Pemberton Services Inc., Tidewater Data Systems, and equivalent formats);
• Database records (including entries in enterprise resource planning (ERP) systems, customer relationship management (CRM) systems, product lifecycle management (PLM) systems, and quality management systems (QMS));
• Digital images, photographs, screenshots, and scanned documents;
• Audio and video files (including recordings of meetings, presentations, and voice messages);
• Metadata associated with all files (including creation dates, modification dates, author information, and version history);
• Instant messages and chat logs (including messages on Meridian Solutions, Northgate Data Systems, Meridian Services Inc., Harborline Technologies, and any other messaging platform);
• Text messages (SMS and MMS) stored on Company-issued or personal devices;
• Social media posts, comments, and direct messages on platforms including Westmark Health IT, Ashford Systems, Kestrel Services Inc., Northpoint Services Inc., and any others;
• Voicemail messages stored on Company phone systems or personal devices;
• Backup tapes, server images, and disaster-recovery archives;
• Archived data in Company-maintained archive repositories or third-party archiving services;
• Cloud-stored data, including data stored in Ashgrove Software, Crestline Software, Larkspur Technologies, box, Westvale Services Inc., Cobalt Ridge Systems, Meridian Systems, or any other cloud-based storage or collaboration platform;
• Data stored on portable devices, including laptops, tablets, smartphones, USB flash drives, external hard drives, SD cards, and any other removable media; and
• CAD files, simulation files, 3D modeling files, and other engineering-specific digital files.
6.2 Paper Documents
Paper documents subject to preservation include, but are not limited to:
• Handwritten notes, annotated documents, and personal notepads;
• Printed correspondence, memoranda, and reports;
• Laboratory notebooks and engineering notebooks;
• Engineering drawings and schematics in physical form;
• Financial records, invoices, purchase orders, and contracts in physical form;
• Regulatory submission binders and supporting documentation in physical form; and
• Any other paper documents that fall within the categories described in Section 5 above.
6.3 Physical Items
Physical items subject to preservation include, but are not limited to:
• Prototypes, pre-production samples, and production samples of the Accused Products;
• Physical testing equipment, fixtures, and test specimens used in design verification, design validation, or quality control testing of the Accused Products;
• Component parts, sub-assemblies, and raw materials unique to the Accused Products;
• Competitor products obtained for benchmarking or reverse engineering purposes; and
• Any other tangible evidence relating to the Accused Products or the Asserted Patents.
6.4 Geographic and Entity Scope
The preservation obligation extends to information in the possession, custody, or control of both Solstice Biomedical Devices Ltd. (Ireland) and Solstice Biomedical, Inc. (Delaware), as well as any other affiliated entities, subsidiaries, or agents acting on behalf of either entity. Materials stored at third-party facilities (including contract manufacturers, warehouses, offsite storage providers, and cloud service providers) that are within the Company's possession, custody, or control are also subject to this hold.
7. Immediate Actions Required
Each custodian receiving this notice must take the following actions immediately upon receipt:
7.1 Suspend All Document Destruction. Immediately suspend any routine document retention or destruction policies, automatic deletion settings, recycling schedules, or other information-management practices that could result in the deletion, destruction, alteration, or disposal of any documents, ESI, or physical materials that are potentially relevant to the Litigation. This includes, without limitation, suspending any scheduled purges of email archives, shared drives, collaboration platforms, or paper filing systems. Do not shred, discard, delete, overwrite, or otherwise dispose of any potentially relevant materials.
7.2 Preserve Backup Systems. Do not overwrite, recycle, degauss, or destroy any backup tapes, server images, archive files, or disaster-recovery media that may contain potentially relevant information. IT personnel should take immediate steps to ensure that automated backup-rotation schedules do not result in the destruction of relevant data. If backup tapes or archive media are maintained by a third-party vendor, IT should notify the vendor immediately that the relevant media must be preserved.
7.3 Notify IT. Contact the IT department immediately (or, if you are an IT custodian, take the following steps directly) to ensure that automatic deletion of emails, temporary files, recycle-bin contents, and other ESI is suspended for all identified custodians. IT should implement mailbox-level preservation holds (e.g., litigation holds in Ashgrove Software or Exchange) for all identified custodians and disable any automatic archiving or deletion policies that could result in the loss of relevant data.
7.4 Secure Physical Evidence. Segregate and secure all physical prototypes, product samples, testing fixtures, component parts, engineering notebooks, and other tangible materials relating to the Accused PrecisionEdge™ products. These items should be placed in a secure, designated location and clearly labeled as subject to the litigation hold. No physical items subject to this hold should be discarded, recycled, disassembled, modified, or transferred without prior authorization from Eamon Rourke, Niamh Cassidy, or Calderwood & Harkness LLP.
7.5 Personal Devices. If you have used any personal device — including a personal smartphone, tablet, laptop, or personal email account (e.g., Northgate Software, Cascade Health IT, Ridgeline Technologies) — for business purposes relating to the Accused Products, the Asserted Patents, Apex, or any other subject matter covered by this hold, you must notify Eamon Rourke or Niamh Cassidy immediately so that appropriate preservation measures can be implemented. Do not delete any potentially relevant data from personal devices pending further instruction from counsel.
7.6 Do Not Create Selective Collections. Do not attempt to sort, cull, filter, review, or selectively collect documents or data on your own initiative. The legal team, in coordination with Calderwood & Harkness LLP, will design and implement a formal, defensible collection process at the appropriate time. Your obligation at this stage is solely to preserve materials in place and to refrain from any actions that could result in the loss or alteration of potentially relevant information.
7.7 Notify Counsel of Special Circumstances. If you are aware of any circumstances that could affect the preservation of relevant materials — for example, materials stored at off-site locations, materials in the custody of third parties, impending system migrations or upgrades, departing employees, or any other unusual situations — please notify Eamon Rourke, Niamh Cassidy, or Calderwood & Harkness LLP immediately.
8. Duration of the Hold
This litigation hold remains in effect until you receive a written release from Calderwood & Harkness LLP or from Eamon Rourke, General Counsel of Solstice Biomedical Devices Ltd. No oral communication, informal notification, or passage of time should be construed as a release of the hold. Do not assume that the hold has been lifted even if you learn that the Litigation has been settled, dismissed, or otherwise resolved; a formal, written release notice will be issued when the preservation obligation has concluded and it is appropriate to resume normal document-management practices.
This hold is an ongoing obligation. As the Litigation progresses, the scope of the hold may be expanded or narrowed based on developments in the case, discovery requests, or court orders. You may receive periodic follow-up reminders or supplemental hold notices from Calderwood & Harkness LLP or from the Company's legal department. Please respond promptly to any such communications and re-confirm your compliance with the hold at each interval.
If you change positions within the Company, transfer to a different department, or leave the Company's employ during the pendency of this hold, you must notify Eamon Rourke or Niamh Cassidy before your transition or departure so that arrangements can be made to preserve any relevant materials in your possession or under your control.
9. Consequences of Non-Compliance
The consequences of failing to comply with this litigation hold are severe and far-reaching. As noted in Section 1, courts have broad authority under Federal Rule of Civil Procedure 37(e) and their inherent powers to impose sanctions for the spoliation of evidence. Such sanctions may include:
• An instruction to the jury that it may or must presume that the destroyed or lost evidence was unfavorable to the Company (an adverse inference instruction);
• Monetary sanctions, including the award of attorney's fees and costs to the opposing party;
• Preclusion of the Company from introducing certain evidence or advancing certain arguments at trial;
• Entry of default judgment or dismissal of the Company's affirmative defenses; and
• Any other remedial measures the Court deems just and appropriate.
These sanctions could critically undermine the Company's defense of the Action and result in substantial financial liability. In addition, individual custodians who fail to preserve relevant materials in violation of this hold may be subject to internal disciplinary action, up to and including termination of employment, in accordance with the Company's policies.
If you are uncertain whether a particular document, file, communication, or physical item falls within the scope of this litigation hold, you must err on the side of preservation. Do not delete, discard, or destroy any item about which you have any doubt. Instead, contact one of the persons listed in Section 10 below for guidance.
10. Questions and Points of Contact
If you have any questions regarding the scope, application, or requirements of this litigation hold, or if you become aware of any potentially relevant materials that may require special preservation measures, please contact one of the following individuals promptly:
Internal Contacts:
Eamon Rourke General Counsel Solstice Biomedical Devices Ltd. Unit 14, Clonskeagh Business Park, Clonskeagh Road, Dublin 14, D14 YF28, Ireland Telephone: +353 1 205 4100
Email: erourke@solsticebiomedical.com
Niamh Cassidy Vice President, Regulatory & IP Solstice Biomedical Devices Ltd. Unit 14, Clonskeagh Business Park, Clonskeagh Road, Dublin 14, D14 YF28, Ireland Telephone: +353 1 205 4118
Email: ncassidy@solsticebiomedical.com
Outside Counsel Contacts:
Marcus Delgado Responsible Partner, intellectual Property Calderwood & Harkness LLP 1201 Market Street, Suite 2500 Wilmington, Delaware 19801 Telephone: (302) 884-7215
Email: mdelgado@calderwoodharkness.com
Christy Bauer Lead Associate, intellectual Property Calderwood & Harkness LLP 1201 Market Street, Suite 2500 Wilmington, Delaware 19801 Telephone: (302) 884-7238
Email: cbauer@calderwoodharkness.com
Please do not hesitate to reach out to any of the above contacts with questions or concerns. Timely communication is essential to ensuring the Company's full compliance with its preservation obligations.
11. Acknowledgment
Each custodian receiving this notice is required to sign and return the Acknowledgment Form set forth below (or submit an electronic acknowledgment, as directed) within five (5) business days of receipt. By signing the Acknowledgment Form, you confirm the following: