1037-00004 · Solstice Biomedical Devices Ltd · Discovery/Outbound

third-party-subpoena-veridian.docx DOCUMENT Litigation

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UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF DELAWARE

AO 88A (Rev. 02/14) Subpoena to Produce Documents, Information, or Objects or to Permit Inspection of Premises in a Civil Action

SUBPOENA TO PRODUCE DOCUMENTS, ELECTRONICALLY STORED INFORMATION, OR OBJECTS OR TO PERMIT INSPECTION OF PREMISES IN A CIVIL ACTION

(Issued Pursuant to Federal Rule of Civil Procedure 45)

Date of Issuance: September 12, 2024

Production of Documents, Electronically Stored Information, or Objects Inspection of Premises Testimony

PART I — IDENTIFICATION OF SUBPOENA RECIPIENT

TO:

Veridian Medical Technologies, Inc.

Attn: Custodian of Records / General Counsel

475 Innovation Drive, Suite 300 Morristown, New Jersey 07960

You are hereby commanded to produce the documents, electronically stored information, and tangible things described in the attached Schedule A at the time, date, and place set forth in Part II of this Subpoena, or to arrange for their production as described herein.

This Subpoena is issued on behalf of Defendant Solstice Biomedical, Inc. in the above-captioned civil action currently pending before the Honorable Chief Judge Richard G. Andrews in the United States District Court for the District of Delaware.

PART II — COMMANDING PRODUCTION

Action Required: Veridian Medical Technologies, Inc. is hereby commanded to produce all documents, electronically stored information, and tangible things described in the attached Schedule A to this Subpoena.

Date of Compliance: Production shall be completed on or before October 14, 2024, which is thirty (30) days from the date of issuance of this Subpoena.

Place of Compliance / Method of Production: Documents and electronically stored information responsive to this Subpoena may be produced by one of the following methods, at the election of the producing party:

(a) Physical delivery to the offices of Calderwood & Harkness LLP, 1201 Market Street, Suite 2500, Wilmington, Delaware 19801, Attention: Marcus Delgado, Esq.; or

(b) Electronic production via secure file transfer protocol (SFTP) or other encrypted cloud-based file sharing platform, the credentials and specifications for which shall be arranged in advance with counsel for Defendant Solstice Biomedical, Inc. at the contact information set forth below.

Inspection of Premises: Not applicable. This Subpoena does not command the inspection of premises.

PART III — ISSUING COURT AND CLERK INFORMATION

Court: United States District Court for the District of Delaware

Address of Court Clerk: J. Caleb Boggs Federal Building, 844 North King Street, Wilmington, Delaware 19801

Issued on Behalf of: Defendant Solstice Biomedical, Inc.

This Subpoena is issued by the undersigned attorney as an officer of the Court, pursuant to Federal Rule of Civil Procedure 45(a)(3), which authorizes an attorney who is authorized to practice in the issuing court to issue and sign a subpoena on behalf of that court.

CALDERWOOD & HARKNESS LLP

By: ________

Marcus Delgado (DE Bar ID No. 5743) 1201 Market Street, Suite 2500 Wilmington, Delaware 19801 Telephone: (302) 555-7100 Facsimile: (302) 555-7101

Email: mdelgado@calderwoodharkness.com

Counsel for Defendant Solstice Biomedical, Inc.

PART IV — NOTICES TO SUBPOENA RECIPIENT

The following notices are provided to the recipient of this Subpoena in accordance with the requirements of Federal Rule of Civil Procedure 45 and the Federal Rules of Civil Procedure generally.

Section A — Duty to Produce / Permit Inspection

This Subpoena commands compliance on the date and at the place (or by the method) specified in Part II above. Pursuant to Federal Rule of Civil Procedure 45(a)(1)(A)(iii), this Subpoena commands the production of designated documents, electronically stored information, and tangible things in the possession, custody, or control of the recipient.

Documents may be produced as they are kept in the usual course of business, or they may be organized and labeled to correspond with the categories set forth in the attached Schedule A. See Fed. R. Civ. P. 45(e)(1)(A). If documents are produced as kept in the usual course of business, they shall be produced in a manner that preserves the organizational structure in which they were maintained, including any folder or directory structure applicable to electronically stored information.

Section B — Protection of Persons Subject to Subpoenas

Persons subject to subpoenas have a right to object to or move to quash or modify the subpoena under Federal Rule of Civil Procedure 45(d). The following protections apply:

1. Objections. Pursuant to Federal Rule of Civil Procedure 45(d)(2)(B), if the recipient objects to any part of this Subpoena, the recipient must serve a written objection on the party or attorney designated in this Subpoena before the earlier of: (i) the time specified for compliance (October 14, 2024); or (ii) fourteen (14) days after service of this Subpoena. If an objection is timely made, the serving party may not inspect or copy the materials sought except pursuant to an order of the court from which the subpoena was issued.

2. Motion to Quash or Modify. The recipient may file a motion to quash or modify this Subpoena in the United States District Court for the District of Delaware pursuant to Federal Rule of Civil Procedure 45(d)(3). A motion to quash or modify must be filed in a timely manner.

3. Privilege. Pursuant to Federal Rule of Civil Procedure 45(e)(2)(A), if any responsive document is withheld on the basis of a claim of privilege or protection as trial-preparation material, the recipient must: (a) expressly assert the claim of privilege; and (b) describe the nature of the withheld documents, communications, or tangible things in a manner that, without revealing the information itself, will enable the parties to assess the claim. Such a description shall be set forth in a privilege log that identifies, at a minimum, the following for each withheld document: the date of the document; the author(s) and all recipients; a general description of the subject matter of the document; and the specific basis for the privilege claim asserted (e.g., attorney-client privilege, work-product doctrine, or other applicable privilege).

4. Undue Burden. Pursuant to Federal Rule of Civil Procedure 45(d)(1), a party or attorney responsible for issuing a subpoena must take reasonable steps to avoid imposing undue burden or expense on a person subject to the subpoena. The issuing court must enforce this duty and impose an appropriate sanction, which may include lost earnings and reasonable attorney's fees, on a party or attorney who fails to comply.

Section C — Contempt Sanctions

WARNING: Failure to obey this Subpoena without adequate excuse may be deemed a contempt of the United States District Court for the District of Delaware, which is the court from which this Subpoena was issued. See Fed. R. Civ. P. 45(g). The court may hold in contempt any person who, having been served with a subpoena, fails without adequate excuse to obey the subpoena or an order related to it. A nonparty's failure to obey may subject the nonparty to civil and/or criminal contempt proceedings and sanctions, including fines and imprisonment.

PART V — DEFINITIONS AND INSTRUCTIONS

Section A — Definitions

As used in this Subpoena and the attached Schedule A, the following terms shall have the meanings set forth below:

1. "Document(s)" shall mean the broadest definition permitted under Federal Rule of Civil Procedure 34(a) and shall include, without limitation, all writings, recordings, data, electronically stored information ("ESI"), communications, photographs, images, drawings, sketches, charts, diagrams, graphs, maps, surveys, blueprints, models, prototypes, tangible items, and all other materials or things, regardless of the medium in which they are created, stored, or maintained. This term includes, but is not limited to: correspondence (whether by letter, memorandum, electronic mail, text message, instant message, or other messaging platform); facsimiles; notes; reports; analyses; presentations; spreadsheets; databases; calendar entries; voicemail recordings; audio and video recordings; drafts (whether or not superseded by final versions); metadata associated with any electronically stored information; and any other data or information that is stored in any electronic, magnetic, optical, or other medium from which it can be retrieved and examined. The term "Document(s)" shall include all originals and all non-identical copies, including copies that differ from the original by reason of any notation, annotation, highlighting, underlining, or other mark made thereon.

2. "Communication(s)" shall mean any transmission, exchange, or sharing of information, ideas, opinions, or data between two or more persons, whether oral, written, or electronic, and regardless of the means by which such transmission occurs. The term includes, without limitation, face-to-face conversations, telephone calls, video conferences, electronic mail messages, text messages, instant messages, letters, memoranda, facsimiles, and any other form of communication.

3. "You," "Your," and "Veridian" shall mean Veridian Medical Technologies, Inc., and shall include its present and former officers, directors, employees, agents, representatives, consultants, contractors, subsidiaries, divisions, predecessors, successors, assigns, and affiliates, and any person or entity acting on its behalf or at its direction.

4. "Asserted Patents" shall mean:

(a) U.S. Patent No. 9,814,237 (hereinafter, "the '237 Patent"), entitled "Locking Seal Assembly for Minimally Invasive Surgical Access Device," issued on November 14, 2017, with an expiration date of June 22, 2035; and

(b) U.S. Patent No. 10,271,884 (hereinafter, "the '884 Patent"), entitled "Retractable Blade Deployment Mechanism for Trocar Systems," issued on April 30, 2019, with an expiration date of September 15, 2036.

5. "Apex" shall mean Apex Surgical Innovations, Inc., including its present and former officers, directors, employees, agents, representatives, subsidiaries, predecessors, successors, assigns, and affiliates.

6. "Solstice" shall mean Solstice Biomedical, Inc. and Solstice Biomedical Devices Ltd., including their present and former officers, directors, employees, agents, representatives, subsidiaries, predecessors, successors, assigns, and affiliates.

7. "Prior Art" shall mean any patent, published patent application, printed publication, publicly available product, public use, sale, offer for sale, or other prior art as defined under 35 U.S.C. §§ 102 and 103, in any jurisdiction, that predates the effective filing dates of the Asserted Patents. For the '237 Patent, the effective filing date is June 22, 2015. For the '884 Patent, the effective filing date is September 15, 2016.

8. "Licensed Products" shall mean any laparoscopic trocar assemblies, surgical access devices, insufflation instruments, or related surgical instruments or components thereof that are or were manufactured, assembled, sold, offered for sale, imported, distributed, marketed, or otherwise commercialized by Veridian at any time during the Relevant Period.

9. "Person" shall mean any natural person, corporation, partnership, limited liability company, joint venture, association, trust, governmental entity, or any other legal entity.

10. "Relevant Period" shall mean January 1, 2000 through the date of production of documents responsive to this Subpoena.

Section B — Instructions

The following instructions apply to the production of documents, electronically stored information, and tangible things pursuant to this Subpoena:

1. Completeness of Production. All documents responsive to this Subpoena shall be produced in their entirety, without redaction (except as required by a valid claim of privilege), including all attachments, appendices, exhibits, enclosures, cover letters, and transmittal materials. Where a responsive document is part of a file, folder, or binder, the entire contents of such file, folder, or binder shall be produced to the extent reasonably necessary to place the responsive document in context.

2. Privilege Log. If any document responsive to this Subpoena is withheld, in whole or in part, on the basis of any claim of privilege, protection as attorney work product, or any other basis, the recipient shall provide a privilege log in accordance with Federal Rule of Civil Procedure 45(e)(2)(A). The privilege log shall identify, for each withheld document or portion thereof:

(a) the date of the document;

(b) the author(s) of the document;

(d) a description of the subject matter of the document in sufficient detail to permit an assessment of the claim of privilege without revealing the privileged information itself;

(e) the specific privilege or protection asserted as the basis for withholding (e.g., attorney-client privilege, attorney work product, joint defense privilege, or other applicable privilege); and

(f) any other information necessary to assess the applicability of the claimed privilege or protection.

The privilege log shall be produced concurrently with the document production, or no later than five (5) business days after the production deadline.

3. Format of ESI Production. Electronically stored information shall be produced in native format, or alternatively as single-page TIFF images (300 DPI, Group IV compression) accompanied by extracted text files (.txt) and metadata load files compatible with industry-standard litigation review platforms (e.g., Relativity, Ashgrove Technologies, or equivalent). Production shall include all available metadata fields, including but not limited to: document date, author, recipients, file path, file name, creation date, last modified date, custodian, and hash values. Production media may include, at the producing party's election: encrypted portable hard drive, secure file transfer protocol (SFTP), or cloud-based encrypted transfer platform. The parties shall confer in good faith regarding the technical specifications for ESI production. Email files (including .pst, .ost, .msg, and .eml formats) shall be produced with all attachments preserved in their parent-child relationships.

4. Identification of Lost or Destroyed Documents. If any document responsive to this Subpoena has been destroyed, discarded, lost, deleted, overwritten, or is otherwise no longer in the possession, custody, or control of the recipient, the recipient shall identify such document with as much specificity as possible, including:

(a) the type and general subject matter of the document;

(b) the author(s) and recipients of the document, if known;

(d) the date and circumstances of its loss, destruction, or disposal; and

(e) the identity of the person(s) who authorized or carried out the destruction, loss, or disposal.

5. Bates Numbering. All documents produced in response to this Subpoena shall be numbered with sequential Bates stamps or an equivalent unique identification system (e.g., "VERIDIAN_0000001") applied to each page. Bates numbers shall be unique and shall not be duplicated across productions. Each responsive document shall bear a Bates number sufficient to identify its beginning and ending pages.

6. Protective Order. This Subpoena is issued subject to the Stipulated Protective Order entered in Apex Surgical Innovations, Inc. v. Solstice Biomedical, Inc., Case No. 1:24-cv-00587-RGA (Dkt. No. 34). To the extent applicable, Veridian may designate materials produced in response to this Subpoena as "CONFIDENTIAL" or "CONFIDENTIAL — ATTORNEYS' EYES ONLY" under the terms of the Stipulated Protective Order. Counsel for Defendant Solstice Biomedical, Inc. will provide a copy of the Stipulated Protective Order to Veridian's counsel upon request. All materials produced by Veridian shall be treated in accordance with the terms of the Stipulated Protective Order, and all parties and their counsel shall be bound by its terms with respect to any documents so designated.

7. Continuing Obligation. If, after serving its production, Veridian discovers additional documents responsive to this Subpoena, Veridian shall promptly supplement its production and produce such additional documents as soon as reasonably practicable.

PART VI — SCHEDULE A: DOCUMENTS AND CATEGORIES REQUESTED

The following categories of documents, electronically stored information, and tangible things are requested from Veridian Medical Technologies, Inc. All requests are subject to the Definitions and Instructions set forth in Part V of this Subpoena.

REQUEST NO. 1 — Patent Applications and Patents Owned or Filed by Veridian

All United States and foreign patent applications (including provisional applications, non-provisional applications, PCT international applications, and national-phase applications), issued patents, continuation applications, divisional applications, and continuation-in-part applications owned by, assigned to, or filed by or on behalf of Veridian Medical Technologies, Inc. relating to any of the following subject matter:

(a) locking seal assemblies for minimally invasive surgical access devices;

(b) retractable blade deployment mechanisms for trocar systems;

(d) insufflation valve assemblies for laparoscopic trocars, including automatic sealing or pressure-regulating valve mechanisms.

This request specifically includes, but is not limited to, complete prosecution file histories (also known as "file wrappers") for each such patent or patent application, including all office actions, examiner interviews and interview summaries, applicant responses and amendments, information disclosure statements (IDS), declarations and affidavits submitted during prosecution, restriction requirements, election of species, notices of allowance, issue fees, maintenance fee records, requests for continued examination (RCE), and any inter partes or post-grant review proceedings (including inter partes review petitions, patent owner responses, and final written decisions by the Patent Trial and Appeal Board).

REQUEST NO. 2 — Published Articles, Technical Papers, and Conference Presentations

All published articles, technical papers, white papers, research reports, conference presentations, conference proceedings, posters, abstracts, dissertations, theses, and other scholarly or technical publications authored or co-authored by any current or former employee, officer, consultant, contractor, or agent of Veridian relating to any of the following subject matter:

(a) locking seal assemblies or self-sealing mechanisms for surgical access devices;

(b) blade deployment mechanisms, including retractable, spring-loaded, or shielded blade systems for trocars;

(d) insufflation management systems, gas seal technologies, or pressure regulation in minimally invasive surgical instruments.

This request is limited to publications or presentations that were published, presented, made publicly available, or otherwise disseminated prior to the earliest effective filing date of the '237 Patent (i.e., prior to June 22, 2015) or the '884 Patent (i.e., prior to September 15, 2016), as applicable, and which may constitute Prior Art to one or both of the Asserted Patents.

REQUEST NO. 3 — Product Design and Engineering Documents

All design documents, engineering drawings, schematics, specifications, technical drawings, computer-aided design (CAD) files (including .dwg, .dxf, .stp, .igs, and Meridian Data Systems files), finite element analysis (FEA) reports, prototypes, prototype photographs, technical reports, design verification and validation (V&V) reports, design history files (DHF), design review meeting minutes, testing records, test protocols, test results, failure mode and effects analyses (FMEA), and any other engineering or design-related documentation relating to any Veridian trocar, surgical access device, or laparoscopic instrument that incorporates any of the following features:

(a) a locking seal mechanism or self-sealing assembly;

(b) a retractable blade deployment mechanism, including spring-actuated, cam-actuated, or lever-actuated blade retraction systems; or

This request encompasses documents created at any time during the Relevant Period (January 1, 2000 through the date of production). This request specifically includes documents relating to any products that were commercially available, offered for sale, in clinical use, or in development prior to the issue dates of the '237 Patent (November 14, 2017) and the '884 Patent (April 30, 2019), as such documents are relevant to the existence and public availability of Prior Art.

REQUEST NO. 4 — Product Catalogs, Marketing Materials, and Sales Records

All product catalogs, product brochures, marketing materials, promotional literature, product data sheets, specification sheets, product comparison charts, instruction manuals, instructions for use (IFU), user guides, training materials, sales records, invoices, purchase orders, distribution records, pricing schedules, and revenue reports for any Veridian product incorporating any of the following features:

(a) locking seal assemblies or self-sealing mechanisms for trocars or surgical access devices;

(b) retractable blade deployment mechanisms for trocars; or

This request is limited to the period from January 1, 2000 through December 31, 2019. This request specifically includes publicly disseminated materials that would evidence public use, public knowledge, commercial availability, sale, or offer for sale of such products prior to the effective filing dates of the Asserted Patents, and is therefore relevant to establishing the existence of Prior Art under 35 U.S.C. §§ 102 and 103.

REQUEST NO. 5 — Communications with Apex or Named Inventors

All documents and communications, of any kind, between Veridian (including any of its current or former employees, officers, directors, agents, consultants, or representatives) and Apex Surgical Innovations, Inc. (including any of its current or former employees, officers, directors, agents, consultants, or representatives), relating to any of the following subjects:

(a) trocar technology, trocar systems, or surgical access device designs;

(b) locking seal assemblies or seal mechanisms for minimally invasive surgical instruments;

(d) any of the Asserted Patents (i.e., the '237 Patent and the '884 Patent);

(e) any joint development, collaboration, research agreement, consulting arrangement, or technology-sharing arrangement between Veridian and Apex relating to the foregoing subject matter; or

(f) any licensing, cross-licensing, or acquisition discussions involving patents or technology related to the foregoing subject matter.

This request specifically includes, but is not limited to, all communications with any of the following named individuals, who are inventors listed on one or both of the Asserted Patents: Dr. Raymond Szabo, Dr. Priya Chandrasekaran, Martin Hale, and Gerald K. Whitford. This request encompasses all communications during the Relevant Period (January 1, 2000 through the date of production).

REQUEST NO. 6 — License Agreements Relating to Trocar or Surgical Access Device Patents

All license agreements, sublicense agreements, cross-license agreements, term sheets, letters of intent, memoranda of understanding, settlement agreements (to the extent they include license grants), royalty agreements, and all related correspondence, between Veridian and any third party (including Apex) relating to any patents, patent applications, or patent portfolios covering any of the following technologies:

(a) trocar systems or trocar components;

(b) locking seal assemblies or self-sealing mechanisms for surgical access devices;

(d) laparoscopic surgical access devices, including insufflation valve assemblies.

This request includes all amendments, addenda, exhibits, schedules, and side letters associated with any such agreement, as well as any correspondence negotiating the terms of such agreements. This request also includes any license agreements between Veridian and Apex, whether currently in effect or expired, relating to any of the Asserted Patents or any patent claiming subject matter substantially similar to the claims of the Asserted Patents.

REQUEST NO. 7 — Prior Art References Identified or Cited by Veridian

All documents reflecting, referencing, identifying, discussing, or analyzing Prior Art references that were identified by Veridian during the prosecution of its own patents or patent applications relating to trocar technology, locking seal assemblies, blade deployment mechanisms, insufflation valve assemblies, or surgical access devices. This request includes, but is not limited to:

(a) prior art search reports, whether prepared internally or by outside counsel or search firms;

(b) invalidity analyses, invalidity contentions, or invalidity charts prepared by or on behalf of Veridian;

(d) information disclosure statements (IDS) submitted by Veridian to the USPTO during the prosecution of any of its own patent applications related to the foregoing technologies;

(e) any prior art submissions or third-party submissions made by Veridian to the USPTO pursuant to 35 U.S.C. § 122(e) or 37 C.F.R. § 1.290; and

(f) any internal memoranda, emails, or reports discussing or evaluating the scope, validity, or relevance of prior art references in the field of laparoscopic trocar technology.

REQUEST NO. 8 — Regulatory Submissions

All FDA 510(k) premarket notifications (including 510(k) summaries and statements), premarket approval (PMA) applications, De Novo classification requests, investigational device exemption (IDE) applications, and any other regulatory submissions filed by Veridian with the United States Food and Drug Administration or any foreign regulatory authority (including submissions to the European Medicines Agency, Notified Bodies under the EU Medical Device Regulation, Health Canada, or the Therapeutic Goods Administration of Australia) for any trocar systems or surgical access devices that include any of the following features:

(a) locking seal assemblies or self-sealing mechanisms;

(b) retractable blade deployment mechanisms; or

This request encompasses such submissions to the extent they contain technical descriptions, device specifications, design drawings, performance testing data, substantial equivalence comparisons, predicate device analyses, or any other technical information relevant to the technology claimed in the '237 Patent and the '884 Patent. To the extent that any regulatory submission contains trade secret or proprietary information not relevant to the subject matter of the Asserted Patents, Veridian may redact such portions, provided that a redaction log is furnished identifying the nature of the redacted material.

REQUEST NO. 9 — Industry Standards and Committee Participation

All documents reflecting Veridian's participation in, membership in, or contribution to any industry standards body, trade association, professional organization, working group, technical committee, or advisory panel relating to laparoscopic surgical access device standards, trocar specifications, or minimally invasive surgical instrument design. This request includes, but is not limited to:

(a) meeting minutes, agendas, attendance records, and presentations from any such body or committee;

(b) draft and final standards documents, technical specifications, recommended practices, or guidance documents to which Veridian contributed;

(c) written submissions, position papers, comments, technical proposals, or ballot responses made by Veridian or its representatives to any standards body concerning trocar seal designs, blade deployment specifications, insufflation valve requirements, or related laparoscopic device standards;

(d) correspondence between Veridian and any standards body, trade association, or working group concerning the foregoing subject matter; and

(e) any internal documents reflecting Veridian's review, analysis, or position regarding proposed or adopted industry standards relating to the foregoing technologies.

This request encompasses participation in organizations including, without limitation, AAMI (Association for the Advancement of Medical Instrumentation), ASTM International, ISO Technical Committee 170 (Surgical Instruments), and any other relevant standards-setting bodies.

REQUEST NO. 10 — Documents Referencing the Asserted Patents

All documents in Veridian's possession, custody, or control that reference, cite, discuss, analyze, or evaluate United States Patent No. 9,814,237 ("the '237 Patent") or United States Patent No. 10,271,884 ("the '884 Patent"), in any context. This request includes, but is not limited to:

(a) design-around studies, analyses, or reports evaluating alternative designs to avoid infringement of the claims of either Asserted Patent;

(b) freedom-to-operate (FTO) opinions, analyses, or charts addressing the claims of either Asserted Patent;

(c) invalidity analyses, invalidity opinions, or invalidity charts evaluating the validity or enforceability of the claims of either Asserted Patent;

(d) claim construction analyses or claim charts mapping the claims of either Asserted Patent to Veridian's products, third-party products, or prior art references;

(e) internal or external memoranda, emails, presentations, or reports discussing either Asserted Patent, including discussions of the scope of the claims, the prosecution history, or the potential impact of either Asserted Patent on Veridian's business operations;

(f) patent landscape analyses, competitive intelligence reports, or technology surveys that reference or discuss either Asserted Patent; and

(g) any correspondence with Apex, Solstice, or any other third party referencing or discussing either Asserted Patent.

PART VII — CERTIFICATE OF SERVICE

I, Marcus Delgado, counsel for Defendant Solstice Biomedical, Inc., hereby certify that on September 12, 2024, a true and correct copy of this Subpoena Duces Tecum, including the attached Schedule A, Definitions, and Instructions, was served upon the following:

1. Veridian Medical Technologies, Inc.

Service by certified mail, return receipt requested, and by personal service upon the Custodian of Records / General Counsel at the following address:

Veridian Medical Technologies, Inc. 475 Innovation Drive, Suite 300 Morristown, New Jersey 07960

2. Counsel for Plaintiff, Apex Surgical Innovations, Inc.

Notice of service on non-party Veridian Medical Technologies, Inc. was provided pursuant to Federal Rule of Civil Procedure 45(a)(4), which requires that notice and a copy of the subpoena be served on each party prior to service on the non-party, by electronic mail and first-class mail to:

Victoria Stanton, Esq. Hargrove, Tate & Bennington LLP 900 North King Street, Suite 1200 Wilmington, Delaware 19801 Telephone: (302) 555-4200 Facsimile: (302) 555-4201

Email: vstanton@htblaw.com

Counsel for Plaintiff Apex Surgical Innovations, Inc.

CALDERWOOD & HARKNESS LLP

By: ________

Marcus Delgado (DE Bar ID No. 5743) 1201 Market Street, Suite 2500 Wilmington, Delaware 19801 Telephone: (302) 555-7100 Facsimile: (302) 555-7101

Email: mdelgado@calderwoodharkness.com

Counsel for Defendant Solstice Biomedical, Inc.

Date: September 12, 2024

ATTACHMENT — AO 88A FORM ELEMENTS

This Subpoena Duces Tecum is issued on the standard AO 88A form (Rev. 02/14) prescribed by the Administrative Office of the United States Courts for subpoenas to produce documents, electronically stored information, or objects, or to permit inspection of premises in a civil action, as authorized by Federal Rule of Civil Procedure 45.

Form Checkbox Selections:

Case Caption Block:

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE

APEX SURGICAL INNOVATIONS, INC., Plaintiff,

SOLSTICE BIOMEDICAL, INC., Defendant.

Civil Action No. 1:24-cv-00587-RGA

Chief Judge Richard G. Andrews

Subpoena Directed To:

Veridian Medical Technologies, Inc. 475 Innovation Drive, Suite 300 Morristown, New Jersey 07960

Attn: Custodian of Records / General Counsel

Issued By:

Marcus Delgado, Esq. Calderwood & Harkness LLP 1201 Market Street, Suite 2500 Wilmington, Delaware 19801 As attorney and officer of the Court, pursuant to Fed. R. Civ. P. 45(a)(3) On behalf of Defendant Solstice Biomedical, Inc.

Date of Issuance: September 12, 2024

Date of Compliance: October 14, 2024

CONFIDENTIAL — SUBJECT TO STIPULATED PROTECTIVE ORDER ENTERED IN CASE NO. 1:24-cv-00587-RGA

APEX SURGICAL INNOVATIONS, INC., a Delaware corporation, 1220 North Market Street, Suite 550, Wilmington, DE 19801,

Plaintiff,

SOLSTICE BIOMEDICAL, INC., a Delaware corporation, 3800 Concord Pike, Suite 410, Wilmington, DE 19803,

Defendant.

Selection	Status
Production of Documents, Electronically Stored Information, or Objects	CHECKED
Inspection of Premises	Unchecked
Testimony	Unchecked

UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
AO 88A (Rev. 02/14) Subpoena to Produce Documents, Information, or Objects or to Permit Inspection of Premises in a Civil Action
SUBPOENA TO PRODUCE DOCUMENTS, ELECTRONICALLY STORED INFORMATION, OR OBJECTS OR TO PERMIT INSPECTION OF PREMISES IN A CIVIL ACTION
(Issued Pursuant to Federal Rule of Civil Procedure 45)
Date of Issuance: September 12, 2024
 Production of Documents, Electronically Stored Information, or Objects  Inspection of Premises  Testimony
PART I — IDENTIFICATION OF SUBPOENA RECIPIENT
TO:
Veridian Medical Technologies, Inc.
Attn: Custodian of Records / General Counsel
475 Innovation Drive, Suite 300 Morristown, New Jersey 07960
You are hereby commanded to produce the documents, electronically stored information, and tangible things described in the attached Schedule A at the time, date, and place set forth in Part II of this Subpoena, or to arrange for their production as described herein.
This Subpoena is issued on behalf of Defendant Solstice Biomedical, Inc. in the above-captioned civil action currently pending before the Honorable Chief Judge Richard G. Andrews in the United States District Court for the District of Delaware.
PART II — COMMANDING PRODUCTION
Action Required: Veridian Medical Technologies, Inc. is hereby commanded to produce all documents, electronically stored information, and tangible things described in the attached Schedule A to this Subpoena.
Date of Compliance: Production shall be completed on or before October 14, 2024, which is thirty (30) days from the date of issuance of this Subpoena.
Place of Compliance / Method of Production: Documents and electronically stored information responsive to this Subpoena may be produced by one of the following methods, at the election of the producing party:
(a) Physical delivery to the offices of Calderwood & Harkness LLP, 1201 Market Street, Suite 2500, Wilmington, Delaware 19801, Attention: Marcus Delgado, Esq.; or
(b) Electronic production via secure file transfer protocol (SFTP) or other encrypted cloud-based file sharing platform, the credentials and specifications for which shall be arranged in advance with counsel for Defendant Solstice Biomedical, Inc. at the contact information set forth below.
Inspection of Premises: Not applicable. This Subpoena does not command the inspection of premises.
PART III — ISSUING COURT AND CLERK INFORMATION
Court: United States District Court for the District of Delaware
Address of Court Clerk: J. Caleb Boggs Federal Building, 844 North King Street, Wilmington, Delaware 19801
Issued on Behalf of: Defendant Solstice Biomedical, Inc.
This Subpoena is issued by the undersigned attorney as an officer of the Court, pursuant to Federal Rule of Civil Procedure 45(a)(3), which authorizes an attorney who is authorized to practice in the issuing court to issue and sign a subpoena on behalf of that court.
CALDERWOOD & HARKNESS LLP
By: ________
Marcus Delgado (DE Bar ID No. 5743) 1201 Market Street, Suite 2500 Wilmington, Delaware 19801 Telephone: (302) 555-7100 Facsimile: (302) 555-7101
Email: mdelgado@calderwoodharkness.com
Counsel for Defendant Solstice Biomedical, Inc.
PART IV — NOTICES TO SUBPOENA RECIPIENT
The following notices are provided to the recipient of this Subpoena in accordance with the requirements of Federal Rule of Civil Procedure 45 and the Federal Rules of Civil Procedure generally.
Section A — Duty to Produce / Permit Inspection
This Subpoena commands compliance on the date and at the place (or by the method) specified in Part II above. Pursuant to Federal Rule of Civil Procedure 45(a)(1)(A)(iii), this Subpoena commands the production of designated documents, electronically stored information, and tangible things in the possession, custody, or control of the recipient.
Documents may be produced as they are kept in the usual course of business, or they may be organized and labeled to correspond with the categories set forth in the attached Schedule A. See Fed. R. Civ. P. 45(e)(1)(A). If documents are produced as kept in the usual course of business, they shall be produced in a manner that preserves the organizational structure in which they were maintained, including any folder or directory structure applicable to electronically stored information.
Section B — Protection of Persons Subject to Subpoenas
Persons subject to subpoenas have a right to object to or move to quash or modify the subpoena under Federal Rule of Civil Procedure 45(d). The following protections apply:
1.  Objections. Pursuant to Federal Rule of Civil Procedure 45(d)(2)(B), if the recipient objects to any part of this Subpoena, the recipient must serve a written objection on the party or attorney designated in this Subpoena before the earlier of: (i) the time specified for compliance (October 14, 2024); or (ii) fourteen (14) days after service of this Subpoena. If an objection is timely made, the serving party may not inspect or copy the materials sought except pursuant to an order of the court from which the subpoena was issued.
2.  Motion to Quash or Modify. The recipient may file a motion to quash or modify this Subpoena in the United States District Court for the District of Delaware pursuant to Federal Rule of Civil Procedure 45(d)(3). A motion to quash or modify must be filed in a timely manner.
3.  Privilege. Pursuant to Federal Rule of Civil Procedure 45(e)(2)(A), if any responsive document is withheld on the basis of a claim of privilege or protection as trial-preparation material, the recipient must: (a) expressly assert the claim of privilege; and (b) describe the nature of the withheld documents, communications, or tangible things in a manner that, without revealing the information itself, will enable the parties to assess the claim. Such a description shall be set forth in a privilege log that identifies, at a minimum, the following for each withheld document: the date of the document; the author(s) and all recipients; a general description of the subject matter of the document; and the specific basis for the privilege claim asserted (e.g., attorney-client privilege, work-product doctrine, or other applicable privilege).
4.  Undue Burden. Pursuant to Federal Rule of Civil Procedure 45(d)(1), a party or attorney responsible for issuing a subpoena must take reasonable steps to avoid imposing undue burden or expense on a person subject to the subpoena. The issuing court must enforce this duty and impose an appropriate sanction, which may include lost earnings and reasonable attorney's fees, on a party or attorney who fails to comply.
Section C — Contempt Sanctions
WARNING: Failure to obey this Subpoena without adequate excuse may be deemed a contempt of the United States District Court for the District of Delaware, which is the court from which this Subpoena was issued. See Fed. R. Civ. P. 45(g). The court may hold in contempt any person who, having been served with a subpoena, fails without adequate excuse to obey the subpoena or an order related to it. A nonparty's failure to obey may subject the nonparty to civil and/or criminal contempt proceedings and sanctions, including fines and imprisonment.
PART V — DEFINITIONS AND INSTRUCTIONS
Section A — Definitions
As used in this Subpoena and the attached Schedule A, the following terms shall have the meanings set forth below:
1. "Document(s)" shall mean the broadest definition permitted under Federal Rule of Civil Procedure 34(a) and shall include, without limitation, all writings, recordings, data, electronically stored information ("ESI"), communications, photographs, images, drawings, sketches, charts, diagrams, graphs, maps, surveys, blueprints, models, prototypes, tangible items, and all other materials or things, regardless of the medium in which they are created, stored, or maintained. This term includes, but is not limited to: correspondence (whether by letter, memorandum, electronic mail, text message, instant message, or other messaging platform); facsimiles; notes; reports; analyses; presentations; spreadsheets; databases; calendar entries; voicemail recordings; audio and video recordings; drafts (whether or not superseded by final versions); metadata associated with any electronically stored information; and any other data or information that is stored in any electronic, magnetic, optical, or other medium from which it can be retrieved and examined. The term "Document(s)" shall include all originals and all non-identical copies, including copies that differ from the original by reason of any notation, annotation, highlighting, underlining, or other mark made thereon.
2. "Communication(s)" shall mean any transmission, exchange, or sharing of information, ideas, opinions, or data between two or more persons, whether oral, written, or electronic, and regardless of the means by which such transmission occurs. The term includes, without limitation, face-to-face conversations, telephone calls, video conferences, electronic mail messages, text messages, instant messages, letters, memoranda, facsimiles, and any other form of communication.
3. "You," "Your," and "Veridian" shall mean Veridian Medical Technologies, Inc., and shall include its present and former officers, directors, employees, agents, representatives, consultants, contractors, subsidiaries, divisions, predecessors, successors, assigns, and affiliates, and any person or entity acting on its behalf or at its direction.
4. "Asserted Patents" shall mean:
(a) U.S. Patent No. 9,814,237 (hereinafter, "the '237 Patent"), entitled "Locking Seal Assembly for Minimally Invasive Surgical Access Device," issued on November 14, 2017, with an expiration date of June 22, 2035; and
(b) U.S. Patent No. 10,271,884 (hereinafter, "the '884 Patent"), entitled "Retractable Blade Deployment Mechanism for Trocar Systems," issued on April 30, 2019, with an expiration date of September 15, 2036.
5. "Apex" shall mean Apex Surgical Innovations, Inc., including its present and former officers, directors, employees, agents, representatives, subsidiaries, predecessors, successors, assigns, and affiliates.
6. "Solstice" shall mean Solstice Biomedical, Inc. and Solstice Biomedical Devices Ltd., including their present and former officers, directors, employees, agents, representatives, subsidiaries, predecessors, successors, assigns, and affiliates.
7. "Prior Art" shall mean any patent, published patent application, printed publication, publicly available product, public use, sale, offer for sale, or other prior art as defined under 35 U.S.C. §§ 102 and 103, in any jurisdiction, that predates the effective filing dates of the Asserted Patents. For the '237 Patent, the effective filing date is June 22, 2015. For the '884 Patent, the effective filing date is September 15, 2016.
8. "Licensed Products" shall mean any laparoscopic trocar assemblies, surgical access devices, insufflation instruments, or related surgical instruments or components thereof that are or were manufactured, assembled, sold, offered for sale, imported, distributed, marketed, or otherwise commercialized by Veridian at any time during the Relevant Period.
9. "Person" shall mean any natural person, corporation, partnership, limited liability company, joint venture, association, trust, governmental entity, or any other legal entity.
10. "Relevant Period" shall mean January 1, 2000 through the date of production of documents responsive to this Subpoena.
Section B — Instructions
The following instructions apply to the production of documents, electronically stored information, and tangible things pursuant to this Subpoena:
1. Completeness of Production. All documents responsive to this Subpoena shall be produced in their entirety, without redaction (except as required by a valid claim of privilege), including all attachments, appendices, exhibits, enclosures, cover letters, and transmittal materials. Where a responsive document is part of a file, folder, or binder, the entire contents of such file, folder, or binder shall be produced to the extent reasonably necessary to place the responsive document in context.
2. Privilege Log. If any document responsive to this Subpoena is withheld, in whole or in part, on the basis of any claim of privilege, protection as attorney work product, or any other basis, the recipient shall provide a privilege log in accordance with Federal Rule of Civil Procedure 45(e)(2)(A). The privilege log shall identify, for each withheld document or portion thereof:
(a) the date of the document;
(b) the author(s) of the document;
(c) all recipients and persons copied on the document;
(d) a description of the subject matter of the document in sufficient detail to permit an assessment of the claim of privilege without revealing the privileged information itself;
(e) the specific privilege or protection asserted as the basis for withholding (e.g., attorney-client privilege, attorney work product, joint defense privilege, or other applicable privilege); and
(f) any other information necessary to assess the applicability of the claimed privilege or protection.
The privilege log shall be produced concurrently with the document production, or no later than five (5) business days after the production deadline.
3. Format of ESI Production. Electronically stored information shall be produced in native format, or alternatively as single-page TIFF images (300 DPI, Group IV compression) accompanied by extracted text files (.txt) and metadata load files compatible with industry-standard litigation review platforms (e.g., Relativity, Ashgrove Technologies, or equivalent). Production shall include all available metadata fields, including but not limited to: document date, author, recipients, file path, file name, creation date, last modified date, custodian, and hash values. Production media may include, at the producing party's election: encrypted portable hard drive, secure file transfer protocol (SFTP), or cloud-based encrypted transfer platform. The parties shall confer in good faith regarding the technical specifications for ESI production. Email files (including .pst, .ost, .msg, and .eml formats) shall be produced with all attachments preserved in their parent-child relationships.
4. Identification of Lost or Destroyed Documents. If any document responsive to this Subpoena has been destroyed, discarded, lost, deleted, overwritten, or is otherwise no longer in the possession, custody, or control of the recipient, the recipient shall identify such document with as much specificity as possible, including:
(a) the type and general subject matter of the document;
(b) the author(s) and recipients of the document, if known;
(c) the approximate date of the document, if known;
(d) the date and circumstances of its loss, destruction, or disposal; and
(e) the identity of the person(s) who authorized or carried out the destruction, loss, or disposal.
5. Bates Numbering. All documents produced in response to this Subpoena shall be numbered with sequential Bates stamps or an equivalent unique identification system (e.g., "VERIDIAN_0000001") applied to each page. Bates numbers shall be unique and shall not be duplicated across productions. Each responsive document shall bear a Bates number sufficient to identify its beginning and ending pages.
6. Protective Order. This Subpoena is issued subject to the Stipulated Protective Order entered in Apex Surgical Innovations, Inc. v. Solstice Biomedical, Inc., Case No. 1:24-cv-00587-RGA (Dkt. No. 34). To the extent applicable, Veridian may designate materials produced in response to this Subpoena as "CONFIDENTIAL" or "CONFIDENTIAL — ATTORNEYS' EYES ONLY" under the terms of the Stipulated Protective Order. Counsel for Defendant Solstice Biomedical, Inc. will provide a copy of the Stipulated Protective Order to Veridian's counsel upon request. All materials produced by Veridian shall be treated in accordance with the terms of the Stipulated Protective Order, and all parties and their counsel shall be bound by its terms with respect to any documents so designated.
7. Continuing Obligation. If, after serving its production, Veridian discovers additional documents responsive to this Subpoena, Veridian shall promptly supplement its production and produce such additional documents as soon as reasonably practicable.
PART VI — SCHEDULE A: DOCUMENTS AND CATEGORIES REQUESTED
The following categories of documents, electronically stored information, and tangible things are requested from Veridian Medical Technologies, Inc. All requests are subject to the Definitions and Instructions set forth in Part V of this Subpoena.
REQUEST NO. 1 — Patent Applications and Patents Owned or Filed by Veridian
All United States and foreign patent applications (including provisional applications, non-provisional applications, PCT international applications, and national-phase applications), issued patents, continuation applications, divisional applications, and continuation-in-part applications owned by, assigned to, or filed by or on behalf of Veridian Medical Technologies, Inc. relating to any of the following subject matter:
(a) locking seal assemblies for minimally invasive surgical access devices;
(b) retractable blade deployment mechanisms for trocar systems;
(c) trocar cannula seal designs, including zero-leak and multi-instrument seal configurations; or
(d) insufflation valve assemblies for laparoscopic trocars, including automatic sealing or pressure-regulating valve mechanisms.
This request specifically includes, but is not limited to, complete prosecution file histories (also known as "file wrappers") for each such patent or patent application, including all office actions, examiner interviews and interview summaries, applicant responses and amendments, information disclosure statements (IDS), declarations and affidavits submitted during prosecution, restriction requirements, election of species, notices of allowance, issue fees, maintenance fee records, requests for continued examination (RCE), and any inter partes or post-grant review proceedings (including inter partes review petitions, patent owner responses, and final written decisions by the Patent Trial and Appeal Board).
REQUEST NO. 2 — Published Articles, Technical Papers, and Conference Presentations
All published articles, technical papers, white papers, research reports, conference presentations, conference proceedings, posters, abstracts, dissertations, theses, and other scholarly or technical publications authored or co-authored by any current or former employee, officer, consultant, contractor, or agent of Veridian relating to any of the following subject matter:
(a) locking seal assemblies or self-sealing mechanisms for surgical access devices;
(b) blade deployment mechanisms, including retractable, spring-loaded, or shielded blade systems for trocars;
(c) trocar systems, cannula designs, or laparoscopic surgical access device configurations; or
(d) insufflation management systems, gas seal technologies, or pressure regulation in minimally invasive surgical instruments.
This request is limited to publications or presentations that were published, presented, made publicly available, or otherwise disseminated prior to the earliest effective filing date of the '237 Patent (i.e., prior to June 22, 2015) or the '884 Patent (i.e., prior to September 15, 2016), as applicable, and which may constitute Prior Art to one or both of the Asserted Patents.
REQUEST NO. 3 — Product Design and Engineering Documents
All design documents, engineering drawings, schematics, specifications, technical drawings, computer-aided design (CAD) files (including .dwg, .dxf, .stp, .igs, and Meridian Data Systems files), finite element analysis (FEA) reports, prototypes, prototype photographs, technical reports, design verification and validation (V&V) reports, design history files (DHF), design review meeting minutes, testing records, test protocols, test results, failure mode and effects analyses (FMEA), and any other engineering or design-related documentation relating to any Veridian trocar, surgical access device, or laparoscopic instrument that incorporates any of the following features:
(a) a locking seal mechanism or self-sealing assembly;
(b) a retractable blade deployment mechanism, including spring-actuated, cam-actuated, or lever-actuated blade retraction systems; or
(c) an integrated insufflation valve or pressure-regulating valve assembly.
This request encompasses documents created at any time during the Relevant Period (January 1, 2000 through the date of production). This request specifically includes documents relating to any products that were commercially available, offered for sale, in clinical use, or in development prior to the issue dates of the '237 Patent (November 14, 2017) and the '884 Patent (April 30, 2019), as such documents are relevant to the existence and public availability of Prior Art.
REQUEST NO. 4 — Product Catalogs, Marketing Materials, and Sales Records
All product catalogs, product brochures, marketing materials, promotional literature, product data sheets, specification sheets, product comparison charts, instruction manuals, instructions for use (IFU), user guides, training materials, sales records, invoices, purchase orders, distribution records, pricing schedules, and revenue reports for any Veridian product incorporating any of the following features:
(a) locking seal assemblies or self-sealing mechanisms for trocars or surgical access devices;
(b) retractable blade deployment mechanisms for trocars; or
(c) insufflation valve assemblies for laparoscopic trocars or related instruments.
This request is limited to the period from January 1, 2000 through December 31, 2019. This request specifically includes publicly disseminated materials that would evidence public use, public knowledge, commercial availability, sale, or offer for sale of such products prior to the effective filing dates of the Asserted Patents, and is therefore relevant to establishing the existence of Prior Art under 35 U.S.C. §§ 102 and 103.
REQUEST NO. 5 — Communications with Apex or Named Inventors
All documents and communications, of any kind, between Veridian (including any of its current or former employees, officers, directors, agents, consultants, or representatives) and Apex Surgical Innovations, Inc. (including any of its current or former employees, officers, directors, agents, consultants, or representatives), relating to any of the following subjects:
(a) trocar technology, trocar systems, or surgical access device designs;
(b) locking seal assemblies or seal mechanisms for minimally invasive surgical instruments;
(c) blade deployment mechanisms, including retractable blade systems;
(d) any of the Asserted Patents (i.e., the '237 Patent and the '884 Patent);
(e) any joint development, collaboration, research agreement, consulting arrangement, or technology-sharing arrangement between Veridian and Apex relating to the foregoing subject matter; or
(f) any licensing, cross-licensing, or acquisition discussions involving patents or technology related to the foregoing subject matter.
This request specifically includes, but is not limited to, all communications with any of the following named individuals, who are inventors listed on one or both of the Asserted Patents: Dr. Raymond Szabo, Dr. Priya Chandrasekaran, Martin Hale, and Gerald K. Whitford. This request encompasses all communications during the Relevant Period (January 1, 2000 through the date of production).
REQUEST NO. 6 — License Agreements Relating to Trocar or Surgical Access Device Patents
All license agreements, sublicense agreements, cross-license agreements, term sheets, letters of intent, memoranda of understanding, settlement agreements (to the extent they include license grants), royalty agreements, and all related correspondence, between Veridian and any third party (including Apex) relating to any patents, patent applications, or patent portfolios covering any of the following technologies:
(a) trocar systems or trocar components;
(b) locking seal assemblies or self-sealing mechanisms for surgical access devices;
(c) retractable blade deployment mechanisms for trocars; or
(d) laparoscopic surgical access devices, including insufflation valve assemblies.
This request includes all amendments, addenda, exhibits, schedules, and side letters associated with any such agreement, as well as any correspondence negotiating the terms of such agreements. This request also includes any license agreements between Veridian and Apex, whether currently in effect or expired, relating to any of the Asserted Patents or any patent claiming subject matter substantially similar to the claims of the Asserted Patents.
REQUEST NO. 7 — Prior Art References Identified or Cited by Veridian
All documents reflecting, referencing, identifying, discussing, or analyzing Prior Art references that were identified by Veridian during the prosecution of its own patents or patent applications relating to trocar technology, locking seal assemblies, blade deployment mechanisms, insufflation valve assemblies, or surgical access devices. This request includes, but is not limited to:
(a) prior art search reports, whether prepared internally or by outside counsel or search firms;
(b) invalidity analyses, invalidity contentions, or invalidity charts prepared by or on behalf of Veridian;
(c) freedom-to-operate (FTO) analyses or opinions prepared by or on behalf of Veridian;
(d) information disclosure statements (IDS) submitted by Veridian to the USPTO during the prosecution of any of its own patent applications related to the foregoing technologies;
(e) any prior art submissions or third-party submissions made by Veridian to the USPTO pursuant to 35 U.S.C. § 122(e) or 37 C.F.R. § 1.290; and
(f) any internal memoranda, emails, or reports discussing or evaluating the scope, validity, or relevance of prior art references in the field of laparoscopic trocar technology.
REQUEST NO. 8 — Regulatory Submissions
All FDA 510(k) premarket notifications (including 510(k) summaries and statements), premarket approval (PMA) applications, De Novo classification requests, investigational device exemption (IDE) applications, and any other regulatory submissions filed by Veridian with the United States Food and Drug Administration or any foreign regulatory authority (including submissions to the European Medicines Agency, Notified Bodies under the EU Medical Device Regulation, Health Canada, or the Therapeutic Goods Administration of Australia) for any trocar systems or surgical access devices that include any of the following features:
(a) locking seal assemblies or self-sealing mechanisms;
(b) retractable blade deployment mechanisms; or
(c) insufflation valve assemblies or gas management systems.
This request encompasses such submissions to the extent they contain technical descriptions, device specifications, design drawings, performance testing data, substantial equivalence comparisons, predicate device analyses, or any other technical information relevant to the technology claimed in the '237 Patent and the '884 Patent. To the extent that any regulatory submission contains trade secret or proprietary information not relevant to the subject matter of the Asserted Patents, Veridian may redact such portions, provided that a redaction log is furnished identifying the nature of the redacted material.
REQUEST NO. 9 — Industry Standards and Committee Participation
All documents reflecting Veridian's participation in, membership in, or contribution to any industry standards body, trade association, professional organization, working group, technical committee, or advisory panel relating to laparoscopic surgical access device standards, trocar specifications, or minimally invasive surgical instrument design. This request includes, but is not limited to:
(a) meeting minutes, agendas, attendance records, and presentations from any such body or committee;
(b) draft and final standards documents, technical specifications, recommended practices, or guidance documents to which Veridian contributed;
(c) written submissions, position papers, comments, technical proposals, or ballot responses made by Veridian or its representatives to any standards body concerning trocar seal designs, blade deployment specifications, insufflation valve requirements, or related laparoscopic device standards;
(d) correspondence between Veridian and any standards body, trade association, or working group concerning the foregoing subject matter; and
(e) any internal documents reflecting Veridian's review, analysis, or position regarding proposed or adopted industry standards relating to the foregoing technologies.
This request encompasses participation in organizations including, without limitation, AAMI (Association for the Advancement of Medical Instrumentation), ASTM International, ISO Technical Committee 170 (Surgical Instruments), and any other relevant standards-setting bodies.
REQUEST NO. 10 — Documents Referencing the Asserted Patents
All documents in Veridian's possession, custody, or control that reference, cite, discuss, analyze, or evaluate United States Patent No. 9,814,237 ("the '237 Patent") or United States Patent No. 10,271,884 ("the '884 Patent"), in any context. This request includes, but is not limited to:
(a) design-around studies, analyses, or reports evaluating alternative designs to avoid infringement of the claims of either Asserted Patent;
(b) freedom-to-operate (FTO) opinions, analyses, or charts addressing the claims of either Asserted Patent;
(c) invalidity analyses, invalidity opinions, or invalidity charts evaluating the validity or enforceability of the claims of either Asserted Patent;
(d) claim construction analyses or claim charts mapping the claims of either Asserted Patent to Veridian's products, third-party products, or prior art references;
(e) internal or external memoranda, emails, presentations, or reports discussing either Asserted Patent, including discussions of the scope of the claims, the prosecution history, or the potential impact of either Asserted Patent on Veridian's business operations;
(f) patent landscape analyses, competitive intelligence reports, or technology surveys that reference or discuss either Asserted Patent; and
(g) any correspondence with Apex, Solstice, or any other third party referencing or discussing either Asserted Patent.
PART VII — CERTIFICATE OF SERVICE
I, Marcus Delgado, counsel for Defendant Solstice Biomedical, Inc., hereby certify that on September 12, 2024, a true and correct copy of this Subpoena Duces Tecum, including the attached Schedule A, Definitions, and Instructions, was served upon the following:
1. Veridian Medical Technologies, Inc.
Service by certified mail, return receipt requested, and by personal service upon the Custodian of Records / General Counsel at the following address:
Veridian Medical Technologies, Inc. 475 Innovation Drive, Suite 300 Morristown, New Jersey 07960
2. Counsel for Plaintiff, Apex Surgical Innovations, Inc.
Notice of service on non-party Veridian Medical Technologies, Inc. was provided pursuant to Federal Rule of Civil Procedure 45(a)(4), which requires that notice and a copy of the subpoena be served on each party prior to service on the non-party, by electronic mail and first-class mail to:
Victoria Stanton, Esq. Hargrove, Tate & Bennington LLP 900 North King Street, Suite 1200 Wilmington, Delaware 19801 Telephone: (302) 555-4200 Facsimile: (302) 555-4201
Email: vstanton@htblaw.com
Counsel for Plaintiff Apex Surgical Innovations, Inc.
CALDERWOOD & HARKNESS LLP
By: ________
Marcus Delgado (DE Bar ID No. 5743) 1201 Market Street, Suite 2500 Wilmington, Delaware 19801 Telephone: (302) 555-7100 Facsimile: (302) 555-7101
Email: mdelgado@calderwoodharkness.com
Counsel for Defendant Solstice Biomedical, Inc.
Date: September 12, 2024
ATTACHMENT — AO 88A FORM ELEMENTS
This Subpoena Duces Tecum is issued on the standard AO 88A form (Rev. 02/14) prescribed by the Administrative Office of the United States Courts for subpoenas to produce documents, electronically stored information, or objects, or to permit inspection of premises in a civil action, as authorized by Federal Rule of Civil Procedure 45.
Form Checkbox Selections:
Case Caption Block:
UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE
APEX SURGICAL INNOVATIONS, INC., Plaintiff,
v.
SOLSTICE BIOMEDICAL, INC., Defendant.
Civil Action No. 1:24-cv-00587-RGA
Chief Judge Richard G. Andrews
Subpoena Directed To:
Veridian Medical Technologies, Inc. 475 Innovation Drive, Suite 300 Morristown, New Jersey 07960
Attn: Custodian of Records / General Counsel
Issued By:
Marcus Delgado, Esq. Calderwood & Harkness LLP 1201 Market Street, Suite 2500 Wilmington, Delaware 19801 As attorney and officer of the Court, pursuant to Fed. R. Civ. P. 45(a)(3) On behalf of Defendant Solstice Biomedical, Inc.
Date of Issuance: September 12, 2024
Date of Compliance: October 14, 2024
CONFIDENTIAL — SUBJECT TO STIPULATED PROTECTIVE ORDER ENTERED IN CASE NO. 1:24-cv-00587-RGA
APEX SURGICAL INNOVATIONS, INC., a Delaware corporation, 1220 North Market Street, Suite 550, Wilmington, DE 19801, | Civil Action No. 1:24-cv-00587-RGA
Plaintiff,
v. | Chief Judge Richard G. Andrews
SOLSTICE BIOMEDICAL, INC., a Delaware corporation, 3800 Concord Pike, Suite 410, Wilmington, DE 19803,
Defendant.
Selection | Status
Production of Documents, Electronically Stored Information, or Objects | CHECKED
Inspection of Premises | Unchecked
Testimony | Unchecked

UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF DELAWARE

CALDERWOOD & HARKNESS LLP

CALDERWOOD & HARKNESS LLP

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE

Record

Parties

Dates

Amounts