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

rule-30b6-deposition-notice.docx DOCUMENT Litigation

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UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE

DEFENDANT SOLSTICE BIOMEDICAL, INC.'S NOTICE OF DEPOSITION PURSUANT TO FEDERAL RULE OF CIVIL PROCEDURE 30(b)(6) OF PLAINTIFF APEX SURGICAL INNOVATIONS, INC.

I. INTRODUCTORY NOTICE

PLEASE TAKE NOTICE that, pursuant to Federal Rules of Civil Procedure 30(b)(1) and 30(b)(6), and the Scheduling Order entered by the Court on July 2, 2024 (D.I. 38), Defendant Solstice Biomedical, Inc. ("Solstice" or "Defendant"), by and through its undersigned counsel, Calderwood & Harkness LLP, hereby notices the deposition of Plaintiff Apex Surgical Innovations, Inc. ("Apex" or "Plaintiff") by one or more officers, directors, managing agents, or other persons designated by Apex to testify on its behalf regarding the matters described in Section V below.

Apex Surgical Innovations, Inc. is a corporation organized and existing under the laws of the State of Delaware, with its principal place of business located at 1220 North Market Street, Suite 550, Wilmington, Delaware 19801. As a party to this action, Apex is obligated, upon receipt of this Notice, to designate and prepare one or more witnesses to testify on its behalf regarding each of the topics set forth herein, in accordance with the requirements of Federal Rule of Civil Procedure 30(b)(6).

II. DEPOSITION LOGISTICS

A. Date, Time, and Location

The deposition of Apex's designated witness(es) shall be taken at the following time and location, or at such other time and location as may be mutually agreed upon by counsel for the parties:

Proposed Dates: November 18, 2024 through November 22, 2024, or such other dates as the parties may agree upon, provided that the deposition shall take place no later than the close of fact discovery as set forth in the Scheduling Order entered by the Court on July 2, 2024 (D.I. 38).

Time: Beginning at 9:30 a.m. Eastern Time and continuing from day to day until completed.

Location: Offices of Calderwood & Harkness LLP, 1201 Market Street, Suite 2500, Wilmington, Delaware 19801. Alternatively, and upon agreement of counsel, the deposition may be taken at the offices of Hargrove, Tate & Bennington LLP, 900 North King Street, Suite 1200, Wilmington, Delaware 19801, or by remote videoconference using a mutually agreeable platform if the parties so agree in writing.

Defendant's counsel will work cooperatively with Plaintiff's counsel to identify mutually convenient dates within the above-referenced timeframe. In the event the parties are unable to reach agreement on the date and location of the deposition, Defendant reserves the right to seek an order from the Court setting the deposition on such terms as the Court deems appropriate.

B. Recording Method

The deposition will be recorded by stenographic means before a certified court reporter, duly authorized to administer oaths under the laws of the State of Delaware. In addition, the deposition may also be recorded simultaneously by videotape, in accordance with Federal Rule of Civil Procedure 30(b)(3)(A)–(B). Solstice will bear the initial cost of the court reporter and any videographer retained at its request. Apex may, at its own expense, arrange for the attendance of its own court reporter and/or videographer, as permitted by the Federal Rules of Civil Procedure.

C. Continuation. If the deposition of Apex's designated witness(es) is not completed in one day, the deposition shall continue on successive business days thereafter until completed. In the event Apex designates multiple witnesses for the topics set forth below, each designated witness shall appear on the date and at the time scheduled for his or her testimony, and the deposition of each such witness shall continue on successive business days, if necessary, until completed.

III. OBLIGATION TO DESIGNATE WITNESSES

Pursuant to Federal Rule of Civil Procedure 30(b)(6), Apex is required to designate one or more officers, directors, managing agents, or other persons who consent to testify on its behalf regarding each of the topics described in Section V below. Each designee must be prepared to testify as to matters known or reasonably available to the organization as a whole, and not merely as to matters within the designee's personal knowledge. Apex's obligation extends to preparing its designee(s) by reviewing relevant documents, interviewing knowledgeable individuals within the organization, and taking all other reasonable steps to ensure that each designee is able to provide complete, knowledgeable, and binding testimony on behalf of Apex regarding each noticed topic.

Apex is requested to identify, in writing, the person or persons it will designate to testify on its behalf for each numbered topic set forth in Section V below no later than ten (10) business days prior to the date of the deposition. Apex's identification of designees should specify which topic(s) each witness will address. In the event that Apex intends to designate more than one witness for a particular topic, Apex should identify each such witness and describe the scope of that witness's anticipated testimony with reasonable specificity.

Failure to designate an adequate witness or to adequately prepare a designee may constitute grounds for sanctions, including but not limited to an order compelling Apex to re-designate and re-produce a witness for further testimony, and/or an order precluding Apex from offering evidence on topics for which an adequate designation was not made. See, e.g., QBE Ins. Corp. v. Jorda Enters., Inc., 277 F.R.D. 676, 688 (S.D. Fla. 2012); Reilly v. NatWest Mkts. Grp., Inc., 181 F.3d 253, 268 (2d Cir. 1999).

IV. DEFINITIONS AND INSTRUCTIONS

A. Definitions. As used in this Notice of Deposition, the following terms shall have the meanings set forth below:

1. "Apex" or "Plaintiff" means Apex Surgical Innovations, Inc., including its current and former officers, directors, employees, agents, consultants, representatives, predecessors, successors, subsidiaries, affiliates, and any persons acting or purporting to act on its behalf.

2. "Solstice" or "Defendant" means Solstice Biomedical, Inc., a Delaware corporation, and its parent company, Solstice Biomedical Devices Ltd., a company organized under the laws of the United Kingdom.

3. "Asserted Patents" means: (a) U.S. Patent No. 9,814,237, entitled "Locking Seal Assembly for Minimally Invasive Surgical Access Device" (hereinafter, "the '237 Patent"); (b) U.S. Patent No. 10,271,884, entitled "Retractable Blade Deployment Mechanism for Trocar Systems" (hereinafter, "the '884 Patent"); and (c) U.S. Patent No. 10,932,105, entitled "Integrated Insufflation Valve and Seal for Laparoscopic Trocar" (hereinafter, "the '105 Patent").

4. "Accused Products" means the PrecisionEdge™ PE-5000 Series, PrecisionEdge™ PE-12000 Series, and PrecisionEdge™ PE-15000 Series laparoscopic trocar assemblies manufactured, sold, offered for sale, imported, and/or used by Solstice in the United States, including all models, configurations, and variations within each such series.

5. "Licensed Patents" or "Apex Trocar Patent Family" means the fourteen (14) issued United States patents and six (6) pending continuation applications in the patent family that includes the Asserted Patents, as identified in Apex's initial disclosures pursuant to Federal Rule of Civil Procedure 26(a)(1) and as further described in the prosecution history of the Asserted Patents.

6. "Relevant Period" means the period from January 1, 2006 (the year Apex Surgical Innovations, Inc. was founded) through the present date.

7. "Document" or "Documents" shall be interpreted as broadly as permitted under Federal Rule of Civil Procedure 34(a) and consistent with the definition set forth in the Joint discovery Plan filed by the parties on July 15, 2024 (D.I. 42), and includes, without limitation, all writings, drawings, graphs, charts, photographs, sound recordings, images, electronically stored information, and other data or data compilations, in any medium from which information can be obtained, translated, if necessary, by the responding party into reasonably usable form.

8. "Communication" or "Communications" means any oral, written, or electronic exchange of information between two or more persons, including but not limited to letters, emails, text messages, instant messages, telephone calls, voicemails, videoconferences, in-person meetings, and any other form of transmitting or receiving information.

9. "Relating to" or "Concerning" means referring to, describing, evidencing, constituting, reflecting, mentioning, pertaining to, connected with, commenting upon, regarding, discussing, setting forth, showing, disclosing, identifying, or having any logical or factual connection with the subject matter referenced.

10. "Person" means any natural person, corporation, partnership, limited liability company, joint venture, association, governmental entity, agency, or other legal or organizational entity.

11. "You" or "Your" means Apex Surgical Innovations, Inc., as defined in Paragraph 1 above.

12. "Named Inventor" means Dr. Raymond Szabo, Vice President of Engineering at Apex Surgical Innovations, Inc., who is identified as the named inventor on each of the Asserted Patents.

B. Instructions.

1. Apex's designated witness(es) should review all documents and materials produced by any party in this litigation in preparation for testimony, including but not limited to Apex's production of 31,450 documents bearing Bates Nos. APEX-000001 through APEX-031450, as well as any documents produced by Solstice, any documents produced by third parties, and any publicly available materials relevant to the topics set forth below. The designee(s) should also consult with knowledgeable Apex employees, officers, and agents as necessary to prepare to provide complete testimony on behalf of the organization.

2. The deposition shall be governed by the Federal Rules of Civil Procedure, including but not limited to Rules 26, 30, and 37, the Local Rules of the United States District Court for the District of Delaware, and any applicable protective order, stipulated confidentiality order, or other order entered in this action, including the Stipulated Protective Order entered on August 5, 2024 (D.I. 55).

3. This Notice of Deposition is served in accordance with the Scheduling Order entered by the Court on July 2, 2024 (D.I. 38), and the Joint discovery Plan filed by the parties on July 15, 2024 (D.I. 42), which collectively govern the timing and scope of discovery in this action.

4. Each topic set forth in Section V below should be read independently and is not intended to narrow or limit any other topic. To the extent that topics overlap, the designee(s) shall be prepared to address each topic fully and independently.

5. Where a topic calls for testimony regarding communications or documents, the designee(s) should be prepared to identify the nature, substance, participants, and approximate dates of such communications or documents to the extent known or reasonably available to the organization.

V. TOPICS FOR EXAMINATION

Apex is required to designate one or more persons to testify on its behalf regarding each of the following topics:

Topic 1: Conception, Development, and Reduction to Practice of the Inventions Claimed in the Asserted Patents

The conception, development, research, experimentation, and reduction to practice of the inventions disclosed and claimed in the Asserted Patents, specifically: the '237 Patent (Locking Seal Assembly for Minimally Invasive Surgical Access Device), the '884 Patent (Retractable Blade Deployment Mechanism for Trocar Systems), and the '105 Patent (Integrated Insufflation Valve and Seal for Laparoscopic Trocar). This topic includes, but is not limited to:

(a) The circumstances, dates, and locations of conception and reduction to practice of each claimed invention;

(b) The role of Dr. Raymond Szabo as the named inventor on all three Asserted Patents, including his specific inventive contributions and the involvement of any co-inventors, collaborators, or contributors (whether credited or uncredited) in the inventive process;

(c) All laboratory notebooks, invention disclosure forms, design documents, engineering drawings, computer-aided design files, prototypes, models, testing records, test reports, and any other records documenting or relating to the development of the claimed inventions;

(d) The relationship between the research and development activities leading to the Asserted Patents and any other products, projects, or research programs at Apex during the Relevant Period; and

(e) Any funding sources, grants, or collaborative agreements that supported the development of the claimed inventions.

Topic 2: Prosecution History of the Asserted Patents

The prosecution of the Asserted Patents before the United States Patent and Trademark Office ("USPTO"), including without limitation:

(a) The preparation and filing of each patent application that resulted in the issuance of the '237 Patent (issued November 14, 2017), the '884 Patent (issued April 30, 2019), and the '105 Patent (issued March 2, 2021);

(b) All communications between Apex, its patent counsel, and the USPTO regarding the prosecution of the Asserted Patents, including office actions, responses to office actions, amendments to claims, declarations or affidavits submitted during prosecution, information disclosure statements, and any petitions or requests filed with the USPTO;

(c) The bases for any claim amendments or arguments made during prosecution of the Asserted Patents, including any narrowing amendments to claim scope and the reasons therefor;

(d) The relationship of the Asserted Patents to the broader Apex Trocar Patent Family, including the fourteen (14) issued United States patents and six (6) pending continuation applications within that family, including any terminal disclaimers, priority claims, and continuity relationships;

(e) Any prior art cited, submitted, or considered during the prosecution of the Asserted Patents, including prior art identified in information disclosure statements, prior art cited in office actions, and prior art of which the named inventor or Apex's patent counsel were aware during prosecution; and

(f) The identity of all patent attorneys and patent agents involved in the prosecution of the Asserted Patents.

Topic 3: Claim Scope and Interpretation of the Asserted Claims

Apex's understanding and interpretation of the scope of the asserted claims of the Asserted Patents, including without limitation:

(a) Claims 1, 3, 7, and 12 of the '237 Patent; Claims 1, 2, 5, 9, and 14 of the '884 Patent; and Claims 1, 4, and 8 of the '105 Patent;

(b) The meaning of each element and limitation of the asserted claims as understood by Apex, including the nine (9) disputed claim terms identified in the parties' exchange of Proposed Claim Constructions on October 22, 2024, and addressed in the Joint Claim Construction Brief filed on November 4, 2024 (D.I. 78);

(c) Any internal analyses, memoranda, opinions, or other documents prepared by or for Apex concerning the scope, meaning, or interpretation of the asserted claims, whether prepared before or after the filing of this litigation;

(d) Apex's position on the proper construction of each disputed claim term and the factual and technical bases for Apex's proposed constructions; and

(e) Any expert analyses or opinions obtained by Apex regarding claim construction.

Topic 4: Apex's Investigation and Basis for Its Infringement Allegations

The investigation conducted by Apex prior to and following the filing of the Complaint on May 9, 2024 (D.I. 1), and the factual and technical bases for Apex's infringement allegations, including without limitation:

(a) The pre-suit investigation conducted by Apex, including any analysis, testing, reverse-engineering, teardown, or inspection of the Accused Products (PrecisionEdge™ PE-5000 Series, PE-12000 Series, and PE-15000 Series laparoscopic trocar assemblies);

(b) The factual and technical bases for Apex's allegations that each Accused Product infringes each asserted claim of the Asserted Patents, including any element-by-element comparison or claim chart prepared by or on behalf of Apex;

(c) The identity of all persons (whether employees, officers, consultants, or outside experts) involved in analyzing the Accused Products and forming Apex's infringement contentions, including the nature and scope of each such person's involvement;

(d) Any communications between Apex and Dr. Calvin Ng of Veltrano Polytechnic Institute, or any other technical consultants, experts, or outside advisors, prior to the filing of the Complaint on May 9, 2024, regarding the Accused Products, the Asserted Patents, or potential infringement;

(e) The factual basis for Apex's Preliminary Infringement Contentions served on September 15, 2024, and any supplements or amendments thereto; and

(f) The timing and manner in which Apex first became aware of the Accused Products and first formed the belief that the Accused Products infringe the Asserted Patents.

Topic 5: Prior Art Known to Apex Relating to the Asserted Patents

All prior art known to Apex relating to the subject matter of the Asserted Patents, including without limitation:

(a) All prior art patents, published patent applications, journal articles, conference publications, technical publications, and other printed publications known to Apex, its officers, employees, and agents (including Dr. Raymond Szabo) relating to the subject matter of the Asserted Patents;

(b) All prior art products, devices, systems, methods, public uses, sales, offers for sale, and public demonstrations known to Apex relating to the subject matter of the Asserted Patents;

(c) Any prior art searches conducted by Apex, or on Apex's behalf by outside counsel, patent search firms, or other third parties, at any time during the Relevant Period, including during prosecution of the Asserted Patents and during this litigation;

(d) Apex's awareness of any third-party products, technologies, or patent portfolios that practice, disclose, or are relevant to the inventions claimed in the Asserted Patents, including but not limited to products manufactured or sold by Veridian Medical Technologies, Inc., or any other competitor in the laparoscopic surgical access device market;

(e) Any duty-of-disclosure obligations owed by Apex and its representatives to the USPTO during prosecution of the Asserted Patents, and the completeness of the information disclosure statements submitted during prosecution of each Asserted Patent; and

(f) Any invalidity opinions, freedom-to-operate analyses, or prior art analyses obtained or prepared by or for Apex at any time.

Topic 6: Licensing History and Practices Relating to the Asserted Patents and the Apex Trocar Patent Family

All licensing activities relating to the Asserted Patents and the broader Apex Trocar Patent Family, including without limitation:

(a) All licenses granted, license negotiations, offers to license, demands for licenses, and any other licensing-related communications relating to the Asserted Patents or any patent in the Apex Trocar Patent Family (fourteen (14) issued patents and six (6) pending applications);

(b) The terms of any executed license agreements, including royalty rates, lump-sum payments, minimum royalty payments, milestone payments, fields of use, territorial limitations, exclusivity provisions, sublicensing rights, and any other material terms and conditions;

(c) Apex's general licensing practices, policies, strategies, and organizational structure relating to the monetization and enforcement of its trocar and surgical access device patent portfolio;

(d) Any licensing revenue received by Apex from the Asserted Patents or the broader Apex Trocar Patent Family during the Relevant Period, including the identity of licensees and the amounts paid under each license agreement;

(e) Any licenses or cross-licenses involving the Asserted Patents or related patent rights granted in connection with settlements of prior patent disputes; and

(f) The identity of all persons within Apex responsible for making licensing and enforcement decisions regarding the Asserted Patents and the Apex Trocar Patent Family.

Topic 7: Apex's Damages Theories and Calculation of Alleged Damages

The factual bases for Apex's damages claims in this action, including without limitation:

(a) Apex's contention that it is entitled to reasonable royalty damages in the amount of $31,800,000, as set forth in the expert report of Hugh Danaher, CFA, of Keystone Valuation Advisors LLC, served on February 14, 2025;

(b) The royalty base used in Apex's damages calculations, including the identification and quantification of the revenue stream to which the royalty rate is applied;

(c) The royalty rate used in Apex's damages calculations, including the factual and economic bases for the selection of that rate;

(d) The application of the Georgia-Pacific factors (as set forth in Georgia-Pacific Corp. v. U.S. Plywood Corp., 318 F. Supp. 1116 (S.D.N.Y. 1970)) by or on behalf of Apex, including the factual bases underlying Apex's analysis of each such factor;

(e) All financial data, sales data, pricing data, cost data, market share analyses, and market analyses relied upon by Apex in formulating its damages position;

(f) Apex's knowledge of the combined United States sales of the Accused Products, the gross margins earned by Solstice on the Accused Products, and any other financial information regarding Solstice's sales or profits used in Apex's damages analysis;

(g) Any alternative damages theories considered but not adopted by Apex, including lost profits theories; and

(h) The instructions, data, assumptions, and materials provided by Apex to its damages expert, Hugh Danaher, CFA, in connection with the preparation of his expert report.

Topic 8: Apex's Commercial Activities Relating to Products Covered by the Asserted Patents

Apex's own commercial activities relating to products covered by the Asserted Patents, including without limitation:

(a) Identification and description of Apex's own products that embody, practice, or are covered by one or more claims of the Asserted Patents, including trocar systems, surgical access devices, insufflation equipment, and any other products incorporating the patented technology;

(b) Apex's sales, revenues, costs of goods sold, gross margins, operating expenses, and net profits for products practicing the Asserted Patents during calendar years 2017 through 2025, broken down by product line and fiscal period to the extent reasonably available;

(c) The competitive relationship, if any, between Apex's products and the Accused Products in the United States market for laparoscopic surgical access devices, including the extent to which Apex and Solstice compete for the same customers, accounts, and market segments;

(d) Apex's estimated fiscal year 2023 revenue of approximately $312 million, and the portion of such revenue attributable to products in the trocar and surgical access device market;

(e) Apex's marketing, promotional, and sales activities relating to products practicing the Asserted Patents; and

(f) Any business plans, strategic plans, or competitive analyses prepared by or for Apex that reference the Accused Products, Solstice, or the competitive landscape for laparoscopic surgical access devices.

Topic 9: Apex's Knowledge of and Interactions with Solstice Prior to Filing the Complaint

All pre-suit interactions and knowledge relating to Solstice, including without limitation:

(a) All communications, meetings, correspondence, telephone calls, emails, or other interactions between Apex (including its officers, directors, employees, agents, and outside counsel) and Solstice (including Solstice Biomedical Devices Ltd. and Solstice Biomedical, Inc.) prior to the filing of the Complaint on May 9, 2024;

(b) Any cease-and-desist letters, demand letters, licensing overtures, or other written or oral demands made by Apex to Solstice, or by Solstice to Apex, relating to the Asserted Patents, the Accused Products, or any other intellectual property matter;

(c) Apex's awareness of, monitoring of, and investigation into Solstice's products, marketing activities, regulatory filings (including FDA 510(k) submissions), trade show appearances, and entry into the United States market for laparoscopic surgical access devices;

(d) The decision-making process within Apex leading to the filing of the patent infringement Complaint, including the roles and involvement of Dr. Priya Chandrasekaran (Chief intellectual Property Officer), Martin Hale (General Counsel), and Gerald K. Whitford (Chief Executive Officer) in evaluating and approving the decision to file suit; and

(e) Any analyses, recommendations, or presentations prepared internally or by outside counsel regarding the advisability, timing, or strategy of filing suit against Solstice.

Topic 10: Assignment and Ownership of the Asserted Patents

The ownership and assignment history of the Asserted Patents, including without limitation:

(a) The chain of title and assignment history for each of the Asserted Patents (the '237 Patent, the '884 Patent, and the '105 Patent), from the named inventor, Dr. Raymond Szabo, to Apex Surgical Innovations, Inc., including all assignments, transfers, and conveyances recorded with the USPTO;

(b) Any encumbrances, security interests, pledges, liens, or third-party rights in or to the Asserted Patents, including any rights granted to lenders, investors, or other parties;

(c) Any agreements between Apex and Dr. Raymond Szabo, or between Apex and any other current or former employees, regarding the assignment of patent rights, inventions, and intellectual property, including employment agreements, invention assignment agreements, and consulting agreements;

(d) Whether any entity or person other than Apex currently holds any ownership interest, license, or other right in or to the Asserted Patents; and

(e) Apex's standing to assert the Asserted Patents in this action.

Topic 11: Apex's Document Retention and Collection Practices Relating to This Litigation

Apex's document retention, preservation, and collection practices as they relate to this litigation, including without limitation:

(a) Apex's general document retention and destruction policies and practices, including any written policies or guidelines, and the manner in which such policies are communicated to and enforced among Apex's employees, officers, and agents;

(b) The steps taken by Apex to identify, preserve, collect, review, and produce documents and electronically stored information ("ESI") responsive to Solstice's discovery requests, including Solstice's First Set of Interrogatories (fifteen (15) interrogatories) and First Set of Requests for Production of Documents (thirty-eight (38) requests) served on August 19, 2024, and Solstice's Second Set of Requests for Production of Documents served on October 14, 2024;

(c) The identity of all custodians from whom documents and ESI were collected for purposes of Apex's production of 31,450 documents bearing Bates Nos. APEX-000001 through APEX-031450, produced on October 7, 2024, including the criteria used to select such custodians;

(d) The search terms, date ranges, and other search criteria used by Apex in identifying documents responsive to Solstice's discovery requests;

(e) Any litigation hold notices issued by Apex in connection with this action, including the dates on which such notices were issued, the identity of the recipients, and the scope of the preservation obligations described therein; and

(f) Any destruction, loss, alteration, or spoliation of potentially relevant documents or data, including any failure to preserve documents or ESI that occurred after Apex reasonably anticipated this litigation.

Topic 12: Inequitable Conduct and Disclosure Obligations During Patent Prosecution

All facts relating to Solstice's counterclaim of inequitable conduct (D.I. 25, Answer and Counterclaims, filed July 29, 2024), including without limitation:

(a) The duty of candor and good faith owed by Apex and its representatives (including Dr. Raymond Szabo, as named inventor, and all patent attorneys and agents involved in the prosecution of the Asserted Patents) to the USPTO during prosecution of the Asserted Patents, as set forth in 37 C.F.R. § 1.56;

(b) The completeness and accuracy of all representations, statements, declarations, and submissions made to the USPTO during prosecution of the Asserted Patents, including the information disclosure statements filed in connection with each Asserted Patent;

(c) Any material prior art, information, or references known to Apex, its officers, the named inventor (Dr. Raymond Szabo), or Apex's patent counsel that were not disclosed to the USPTO during prosecution of any of the Asserted Patents, and the reasons, if any, for any such non-disclosure;

(d) Any internal communications, emails, memoranda, or other documents discussing whether to disclose particular prior art references or other material information to the USPTO during prosecution of the Asserted Patents;

(e) Any intent to deceive the USPTO on the part of any individual involved in the prosecution of the Asserted Patents; and

(f) Any policies or procedures maintained by Apex regarding the identification and disclosure of material prior art to the USPTO during patent prosecution.

VI. DOCUMENT REQUEST ACCOMPANYING DEPOSITION NOTICE

Pursuant to Federal Rule of Civil Procedure 30(b)(2), which permits a deposition notice to be accompanied by a request for the production of documents, Solstice hereby requests that Apex's designated witness(es) bring to the deposition any and all documents reviewed by the designee(s) in preparation for testimony that have not already been produced in this litigation. Without limiting the generality of the foregoing, Solstice specifically requests that the designee(s) bring to the deposition the following categories of documents, to the extent not already produced:

(a) All inventor notebooks, laboratory notebooks, research notes, and records of Dr. Raymond Szabo relating to the conception, development, and reduction to practice of the inventions claimed in the Asserted Patents;

(b) All executed license agreements, term sheets, and licensing correspondence relating to the Asserted Patents or any patent within the Apex Trocar Patent Family;

(c) All internal analyses, presentations, memoranda, reports, or other documents relating to the Accused Products (PrecisionEdge™ PE-5000, PE-12000, and PE-15000 Series), including any competitive analyses or product comparisons;

(d) All documents relating to Apex's damages calculations and the data underlying the expert report of Hugh Danaher, CFA, of Keystone Valuation Advisors LLC, served on February 14, 2025, including financial models, spreadsheets, data inputs, assumptions, and supporting documentation;

(e) Any documents relating to Apex's pre-suit investigation of the Accused Products, including teardown reports, testing results, photographs, and claim charts; and

(f) Any other documents reviewed by the designee(s) in preparation for testimony on any topic set forth in Section V above.

To the extent that any such documents are subject to a claim of privilege or work-product protection, Apex shall identify such documents on a privilege log in accordance with Federal Rule of Civil Procedure 26(b)(5) and the procedures established in the Joint discovery Plan.

VII. RESERVATION OF RIGHTS

Solstice expressly reserves the right to supplement or amend the topics listed in Section V of this Notice, and to add additional topics for examination, upon agreement of the parties or by leave of Court. Any such supplementation or amendment shall be without prejudice to the topics already noticed herein.

Solstice further reserves the right to depose additional officers, directors, employees, or agents of Apex on an individual basis, pursuant to Federal Rule of Civil Procedure 30(b)(1), on the topics identified herein or on any other topics relevant to the claims and defenses in this action, subject to the limitations set forth in the Federal Rules of Civil Procedure and the Scheduling Order.

This Notice is without prejudice to Solstice's right to take additional depositions of Apex or third parties as permitted by the Federal Rules of Civil Procedure, the Local Rules of the United States District Court for the District of Delaware, and the Scheduling Order entered in this action.

VIII. COMPLIANCE WITH LOCAL RULES

This Notice of Deposition is served in compliance with Local Rule 30.1 of the United States District Court for the District of Delaware, and all other applicable Local Rules governing the taking of depositions. The undersigned counsel certifies that, prior to serving this Notice, a good faith effort was made to confer with counsel for Plaintiff regarding the scheduling and logistics of the deposition, consistent with the parties' obligations under the Joint discovery Plan filed on July 15, 2024 (D.I. 42) and the Court's standing practices.

Respectfully submitted,

CALDERWOOD & HARKNESS LLP

By: ________

Marcus Delgado (Del. Bar No. 5318) Christy Bauer (Del. Bar No. 6274) Peter Vassiliev (Del. Bar No. 6890)

1201 Market Street, Suite 2500 Wilmington, Delaware 19801 Telephone: (302) 555-4200 Facsimile: (302) 555-4201

Email: mdelgado@calderwoodharkness.com

Email: cbauer@calderwoodharkness.com

Email: pvassiliev@calderwoodharkness.com

Counsel for Defendant Solstice Biomedical, Inc.

Dated: November 1, 2024

CERTIFICATE OF SERVICE

I, Christy Bauer, hereby certify that on this 1st day of November, 2024, a true and correct copy of the foregoing Defendant Solstice Biomedical, Inc.'s Notice of Deposition Pursuant to Federal Rule of Civil Procedure 30(b)(6) of Plaintiff Apex Surgical Innovations, Inc. was served upon the following counsel of record via electronic filing through the Court's CM/ECF system, which will send a Notice of Electronic Filing to all registered participants, and by email to the addresses listed below:

Victoria Stanton, Esq. Derek Loomis, Esq. Hargrove, Tate & Bennington LLP 900 North King Street, Suite 1200 Wilmington, Delaware 19801 Telephone: (302) 555-7800

Email: vstanton@htblaw.com

Email: dloomis@htblaw.com

Counsel for Plaintiff Apex Surgical Innovations, Inc.

________________________________________

Christy Bauer (Del. Bar No. 6274) CALDERWOOD & HARKNESS LLP

APEX SURGICAL INNOVATIONS, INC.,

<!-- indent:2 -->Plaintiff,<!-- /indent -->	Civil Action No. 1:24-cv-00587-RGA
v.	Chief Judge Richard G. Andrews

SOLSTICE BIOMEDICAL, INC.,

Defendant.

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE
DEFENDANT SOLSTICE BIOMEDICAL, INC.'S NOTICE OF DEPOSITION PURSUANT TO FEDERAL RULE OF CIVIL PROCEDURE 30(b)(6) OF PLAINTIFF APEX SURGICAL INNOVATIONS, INC.
I. INTRODUCTORY NOTICE
PLEASE TAKE NOTICE that, pursuant to Federal Rules of Civil Procedure 30(b)(1) and 30(b)(6), and the Scheduling Order entered by the Court on July 2, 2024 (D.I. 38), Defendant Solstice Biomedical, Inc. ("Solstice" or "Defendant"), by and through its undersigned counsel, Calderwood & Harkness LLP, hereby notices the deposition of Plaintiff Apex Surgical Innovations, Inc. ("Apex" or "Plaintiff") by one or more officers, directors, managing agents, or other persons designated by Apex to testify on its behalf regarding the matters described in Section V below.
Apex Surgical Innovations, Inc. is a corporation organized and existing under the laws of the State of Delaware, with its principal place of business located at 1220 North Market Street, Suite 550, Wilmington, Delaware 19801. As a party to this action, Apex is obligated, upon receipt of this Notice, to designate and prepare one or more witnesses to testify on its behalf regarding each of the topics set forth herein, in accordance with the requirements of Federal Rule of Civil Procedure 30(b)(6).
II. DEPOSITION LOGISTICS
A. Date, Time, and Location
The deposition of Apex's designated witness(es) shall be taken at the following time and location, or at such other time and location as may be mutually agreed upon by counsel for the parties:
Proposed Dates: November 18, 2024 through November 22, 2024, or such other dates as the parties may agree upon, provided that the deposition shall take place no later than the close of fact discovery as set forth in the Scheduling Order entered by the Court on July 2, 2024 (D.I. 38).
Time: Beginning at 9:30 a.m. Eastern Time and continuing from day to day until completed.
Location: Offices of Calderwood & Harkness LLP, 1201 Market Street, Suite 2500, Wilmington, Delaware 19801. Alternatively, and upon agreement of counsel, the deposition may be taken at the offices of Hargrove, Tate & Bennington LLP, 900 North King Street, Suite 1200, Wilmington, Delaware 19801, or by remote videoconference using a mutually agreeable platform if the parties so agree in writing.
Defendant's counsel will work cooperatively with Plaintiff's counsel to identify mutually convenient dates within the above-referenced timeframe. In the event the parties are unable to reach agreement on the date and location of the deposition, Defendant reserves the right to seek an order from the Court setting the deposition on such terms as the Court deems appropriate.
B. Recording Method
The deposition will be recorded by stenographic means before a certified court reporter, duly authorized to administer oaths under the laws of the State of Delaware. In addition, the deposition may also be recorded simultaneously by videotape, in accordance with Federal Rule of Civil Procedure 30(b)(3)(A)–(B). Solstice will bear the initial cost of the court reporter and any videographer retained at its request. Apex may, at its own expense, arrange for the attendance of its own court reporter and/or videographer, as permitted by the Federal Rules of Civil Procedure.
C. Continuation.  If the deposition of Apex's designated witness(es) is not completed in one day, the deposition shall continue on successive business days thereafter until completed. In the event Apex designates multiple witnesses for the topics set forth below, each designated witness shall appear on the date and at the time scheduled for his or her testimony, and the deposition of each such witness shall continue on successive business days, if necessary, until completed.
III. OBLIGATION TO DESIGNATE WITNESSES
Pursuant to Federal Rule of Civil Procedure 30(b)(6), Apex is required to designate one or more officers, directors, managing agents, or other persons who consent to testify on its behalf regarding each of the topics described in Section V below. Each designee must be prepared to testify as to matters known or reasonably available to the organization as a whole, and not merely as to matters within the designee's personal knowledge. Apex's obligation extends to preparing its designee(s) by reviewing relevant documents, interviewing knowledgeable individuals within the organization, and taking all other reasonable steps to ensure that each designee is able to provide complete, knowledgeable, and binding testimony on behalf of Apex regarding each noticed topic.
Apex is requested to identify, in writing, the person or persons it will designate to testify on its behalf for each numbered topic set forth in Section V below no later than ten (10) business days prior to the date of the deposition. Apex's identification of designees should specify which topic(s) each witness will address. In the event that Apex intends to designate more than one witness for a particular topic, Apex should identify each such witness and describe the scope of that witness's anticipated testimony with reasonable specificity.
Failure to designate an adequate witness or to adequately prepare a designee may constitute grounds for sanctions, including but not limited to an order compelling Apex to re-designate and re-produce a witness for further testimony, and/or an order precluding Apex from offering evidence on topics for which an adequate designation was not made. See, e.g., QBE Ins. Corp. v. Jorda Enters., Inc., 277 F.R.D. 676, 688 (S.D. Fla. 2012); Reilly v. NatWest Mkts. Grp., Inc., 181 F.3d 253, 268 (2d Cir. 1999).
IV. DEFINITIONS AND INSTRUCTIONS
A. Definitions.  As used in this Notice of Deposition, the following terms shall have the meanings set forth below:
1.  "Apex" or "Plaintiff" means Apex Surgical Innovations, Inc., including its current and former officers, directors, employees, agents, consultants, representatives, predecessors, successors, subsidiaries, affiliates, and any persons acting or purporting to act on its behalf.
2.  "Solstice" or "Defendant" means Solstice Biomedical, Inc., a Delaware corporation, and its parent company, Solstice Biomedical Devices Ltd., a company organized under the laws of the United Kingdom.
3.  "Asserted Patents" means: (a) U.S. Patent No. 9,814,237, entitled "Locking Seal Assembly for Minimally Invasive Surgical Access Device" (hereinafter, "the '237 Patent"); (b) U.S. Patent No. 10,271,884, entitled "Retractable Blade Deployment Mechanism for Trocar Systems" (hereinafter, "the '884 Patent"); and (c) U.S. Patent No. 10,932,105, entitled "Integrated Insufflation Valve and Seal for Laparoscopic Trocar" (hereinafter, "the '105 Patent").
4.  "Accused Products" means the PrecisionEdge™ PE-5000 Series, PrecisionEdge™ PE-12000 Series, and PrecisionEdge™ PE-15000 Series laparoscopic trocar assemblies manufactured, sold, offered for sale, imported, and/or used by Solstice in the United States, including all models, configurations, and variations within each such series.
5.  "Licensed Patents" or "Apex Trocar Patent Family" means the fourteen (14) issued United States patents and six (6) pending continuation applications in the patent family that includes the Asserted Patents, as identified in Apex's initial disclosures pursuant to Federal Rule of Civil Procedure 26(a)(1) and as further described in the prosecution history of the Asserted Patents.
6.  "Relevant Period" means the period from January 1, 2006 (the year Apex Surgical Innovations, Inc. was founded) through the present date.
7.  "Document" or "Documents" shall be interpreted as broadly as permitted under Federal Rule of Civil Procedure 34(a) and consistent with the definition set forth in the Joint discovery Plan filed by the parties on July 15, 2024 (D.I. 42), and includes, without limitation, all writings, drawings, graphs, charts, photographs, sound recordings, images, electronically stored information, and other data or data compilations, in any medium from which information can be obtained, translated, if necessary, by the responding party into reasonably usable form.
8.  "Communication" or "Communications" means any oral, written, or electronic exchange of information between two or more persons, including but not limited to letters, emails, text messages, instant messages, telephone calls, voicemails, videoconferences, in-person meetings, and any other form of transmitting or receiving information.
9.  "Relating to" or "Concerning" means referring to, describing, evidencing, constituting, reflecting, mentioning, pertaining to, connected with, commenting upon, regarding, discussing, setting forth, showing, disclosing, identifying, or having any logical or factual connection with the subject matter referenced.
10.  "Person" means any natural person, corporation, partnership, limited liability company, joint venture, association, governmental entity, agency, or other legal or organizational entity.
11.  "You" or "Your" means Apex Surgical Innovations, Inc., as defined in Paragraph 1 above.
12.  "Named Inventor" means Dr. Raymond Szabo, Vice President of Engineering at Apex Surgical Innovations, Inc., who is identified as the named inventor on each of the Asserted Patents.
B. Instructions.  
1.  Apex's designated witness(es) should review all documents and materials produced by any party in this litigation in preparation for testimony, including but not limited to Apex's production of 31,450 documents bearing Bates Nos. APEX-000001 through APEX-031450, as well as any documents produced by Solstice, any documents produced by third parties, and any publicly available materials relevant to the topics set forth below. The designee(s) should also consult with knowledgeable Apex employees, officers, and agents as necessary to prepare to provide complete testimony on behalf of the organization.
2.  The deposition shall be governed by the Federal Rules of Civil Procedure, including but not limited to Rules 26, 30, and 37, the Local Rules of the United States District Court for the District of Delaware, and any applicable protective order, stipulated confidentiality order, or other order entered in this action, including the Stipulated Protective Order entered on August 5, 2024 (D.I. 55).
3.  This Notice of Deposition is served in accordance with the Scheduling Order entered by the Court on July 2, 2024 (D.I. 38), and the Joint discovery Plan filed by the parties on July 15, 2024 (D.I. 42), which collectively govern the timing and scope of discovery in this action.
4.  Each topic set forth in Section V below should be read independently and is not intended to narrow or limit any other topic. To the extent that topics overlap, the designee(s) shall be prepared to address each topic fully and independently.
5.  Where a topic calls for testimony regarding communications or documents, the designee(s) should be prepared to identify the nature, substance, participants, and approximate dates of such communications or documents to the extent known or reasonably available to the organization.
V. TOPICS FOR EXAMINATION
Apex is required to designate one or more persons to testify on its behalf regarding each of the following topics:
Topic 1: Conception, Development, and Reduction to Practice of the Inventions Claimed in the Asserted Patents
The conception, development, research, experimentation, and reduction to practice of the inventions disclosed and claimed in the Asserted Patents, specifically: the '237 Patent (Locking Seal Assembly for Minimally Invasive Surgical Access Device), the '884 Patent (Retractable Blade Deployment Mechanism for Trocar Systems), and the '105 Patent (Integrated Insufflation Valve and Seal for Laparoscopic Trocar). This topic includes, but is not limited to:
(a) The circumstances, dates, and locations of conception and reduction to practice of each claimed invention;
(b) The role of Dr. Raymond Szabo as the named inventor on all three Asserted Patents, including his specific inventive contributions and the involvement of any co-inventors, collaborators, or contributors (whether credited or uncredited) in the inventive process;
(c) All laboratory notebooks, invention disclosure forms, design documents, engineering drawings, computer-aided design files, prototypes, models, testing records, test reports, and any other records documenting or relating to the development of the claimed inventions;
(d) The relationship between the research and development activities leading to the Asserted Patents and any other products, projects, or research programs at Apex during the Relevant Period; and
(e) Any funding sources, grants, or collaborative agreements that supported the development of the claimed inventions.
Topic 2: Prosecution History of the Asserted Patents
The prosecution of the Asserted Patents before the United States Patent and Trademark Office ("USPTO"), including without limitation:
(a) The preparation and filing of each patent application that resulted in the issuance of the '237 Patent (issued November 14, 2017), the '884 Patent (issued April 30, 2019), and the '105 Patent (issued March 2, 2021);
(b) All communications between Apex, its patent counsel, and the USPTO regarding the prosecution of the Asserted Patents, including office actions, responses to office actions, amendments to claims, declarations or affidavits submitted during prosecution, information disclosure statements, and any petitions or requests filed with the USPTO;
(c) The bases for any claim amendments or arguments made during prosecution of the Asserted Patents, including any narrowing amendments to claim scope and the reasons therefor;
(d) The relationship of the Asserted Patents to the broader Apex Trocar Patent Family, including the fourteen (14) issued United States patents and six (6) pending continuation applications within that family, including any terminal disclaimers, priority claims, and continuity relationships;
(e) Any prior art cited, submitted, or considered during the prosecution of the Asserted Patents, including prior art identified in information disclosure statements, prior art cited in office actions, and prior art of which the named inventor or Apex's patent counsel were aware during prosecution; and
(f) The identity of all patent attorneys and patent agents involved in the prosecution of the Asserted Patents.
Topic 3: Claim Scope and Interpretation of the Asserted Claims
Apex's understanding and interpretation of the scope of the asserted claims of the Asserted Patents, including without limitation:
(a) Claims 1, 3, 7, and 12 of the '237 Patent; Claims 1, 2, 5, 9, and 14 of the '884 Patent; and Claims 1, 4, and 8 of the '105 Patent;
(b) The meaning of each element and limitation of the asserted claims as understood by Apex, including the nine (9) disputed claim terms identified in the parties' exchange of Proposed Claim Constructions on October 22, 2024, and addressed in the Joint Claim Construction Brief filed on November 4, 2024 (D.I. 78);
(c) Any internal analyses, memoranda, opinions, or other documents prepared by or for Apex concerning the scope, meaning, or interpretation of the asserted claims, whether prepared before or after the filing of this litigation;
(d) Apex's position on the proper construction of each disputed claim term and the factual and technical bases for Apex's proposed constructions; and
(e) Any expert analyses or opinions obtained by Apex regarding claim construction.
Topic 4: Apex's Investigation and Basis for Its Infringement Allegations
The investigation conducted by Apex prior to and following the filing of the Complaint on May 9, 2024 (D.I. 1), and the factual and technical bases for Apex's infringement allegations, including without limitation:
(a) The pre-suit investigation conducted by Apex, including any analysis, testing, reverse-engineering, teardown, or inspection of the Accused Products (PrecisionEdge™ PE-5000 Series, PE-12000 Series, and PE-15000 Series laparoscopic trocar assemblies);
(b) The factual and technical bases for Apex's allegations that each Accused Product infringes each asserted claim of the Asserted Patents, including any element-by-element comparison or claim chart prepared by or on behalf of Apex;
(c) The identity of all persons (whether employees, officers, consultants, or outside experts) involved in analyzing the Accused Products and forming Apex's infringement contentions, including the nature and scope of each such person's involvement;
(d) Any communications between Apex and Dr. Calvin Ng of Veltrano Polytechnic Institute, or any other technical consultants, experts, or outside advisors, prior to the filing of the Complaint on May 9, 2024, regarding the Accused Products, the Asserted Patents, or potential infringement;
(e) The factual basis for Apex's Preliminary Infringement Contentions served on September 15, 2024, and any supplements or amendments thereto; and
(f) The timing and manner in which Apex first became aware of the Accused Products and first formed the belief that the Accused Products infringe the Asserted Patents.
Topic 5: Prior Art Known to Apex Relating to the Asserted Patents
All prior art known to Apex relating to the subject matter of the Asserted Patents, including without limitation:
(a) All prior art patents, published patent applications, journal articles, conference publications, technical publications, and other printed publications known to Apex, its officers, employees, and agents (including Dr. Raymond Szabo) relating to the subject matter of the Asserted Patents;
(b) All prior art products, devices, systems, methods, public uses, sales, offers for sale, and public demonstrations known to Apex relating to the subject matter of the Asserted Patents;
(c) Any prior art searches conducted by Apex, or on Apex's behalf by outside counsel, patent search firms, or other third parties, at any time during the Relevant Period, including during prosecution of the Asserted Patents and during this litigation;
(d) Apex's awareness of any third-party products, technologies, or patent portfolios that practice, disclose, or are relevant to the inventions claimed in the Asserted Patents, including but not limited to products manufactured or sold by Veridian Medical Technologies, Inc., or any other competitor in the laparoscopic surgical access device market;
(e) Any duty-of-disclosure obligations owed by Apex and its representatives to the USPTO during prosecution of the Asserted Patents, and the completeness of the information disclosure statements submitted during prosecution of each Asserted Patent; and
(f) Any invalidity opinions, freedom-to-operate analyses, or prior art analyses obtained or prepared by or for Apex at any time.
Topic 6: Licensing History and Practices Relating to the Asserted Patents and the Apex Trocar Patent Family
All licensing activities relating to the Asserted Patents and the broader Apex Trocar Patent Family, including without limitation:
(a) All licenses granted, license negotiations, offers to license, demands for licenses, and any other licensing-related communications relating to the Asserted Patents or any patent in the Apex Trocar Patent Family (fourteen (14) issued patents and six (6) pending applications);
(b) The terms of any executed license agreements, including royalty rates, lump-sum payments, minimum royalty payments, milestone payments, fields of use, territorial limitations, exclusivity provisions, sublicensing rights, and any other material terms and conditions;
(c) Apex's general licensing practices, policies, strategies, and organizational structure relating to the monetization and enforcement of its trocar and surgical access device patent portfolio;
(d) Any licensing revenue received by Apex from the Asserted Patents or the broader Apex Trocar Patent Family during the Relevant Period, including the identity of licensees and the amounts paid under each license agreement;
(e) Any licenses or cross-licenses involving the Asserted Patents or related patent rights granted in connection with settlements of prior patent disputes; and
(f) The identity of all persons within Apex responsible for making licensing and enforcement decisions regarding the Asserted Patents and the Apex Trocar Patent Family.
Topic 7: Apex's Damages Theories and Calculation of Alleged Damages
The factual bases for Apex's damages claims in this action, including without limitation:
(a) Apex's contention that it is entitled to reasonable royalty damages in the amount of $31,800,000, as set forth in the expert report of Hugh Danaher, CFA, of Keystone Valuation Advisors LLC, served on February 14, 2025;
(b) The royalty base used in Apex's damages calculations, including the identification and quantification of the revenue stream to which the royalty rate is applied;
(c) The royalty rate used in Apex's damages calculations, including the factual and economic bases for the selection of that rate;
(d) The application of the Georgia-Pacific factors (as set forth in Georgia-Pacific Corp. v. U.S. Plywood Corp., 318 F. Supp. 1116 (S.D.N.Y. 1970)) by or on behalf of Apex, including the factual bases underlying Apex's analysis of each such factor;
(e) All financial data, sales data, pricing data, cost data, market share analyses, and market analyses relied upon by Apex in formulating its damages position;
(f) Apex's knowledge of the combined United States sales of the Accused Products, the gross margins earned by Solstice on the Accused Products, and any other financial information regarding Solstice's sales or profits used in Apex's damages analysis;
(g) Any alternative damages theories considered but not adopted by Apex, including lost profits theories; and
(h) The instructions, data, assumptions, and materials provided by Apex to its damages expert, Hugh Danaher, CFA, in connection with the preparation of his expert report.
Topic 8: Apex's Commercial Activities Relating to Products Covered by the Asserted Patents
Apex's own commercial activities relating to products covered by the Asserted Patents, including without limitation:
(a) Identification and description of Apex's own products that embody, practice, or are covered by one or more claims of the Asserted Patents, including trocar systems, surgical access devices, insufflation equipment, and any other products incorporating the patented technology;
(b) Apex's sales, revenues, costs of goods sold, gross margins, operating expenses, and net profits for products practicing the Asserted Patents during calendar years 2017 through 2025, broken down by product line and fiscal period to the extent reasonably available;
(c) The competitive relationship, if any, between Apex's products and the Accused Products in the United States market for laparoscopic surgical access devices, including the extent to which Apex and Solstice compete for the same customers, accounts, and market segments;
(d) Apex's estimated fiscal year 2023 revenue of approximately $312 million, and the portion of such revenue attributable to products in the trocar and surgical access device market;
(e) Apex's marketing, promotional, and sales activities relating to products practicing the Asserted Patents; and
(f) Any business plans, strategic plans, or competitive analyses prepared by or for Apex that reference the Accused Products, Solstice, or the competitive landscape for laparoscopic surgical access devices.
Topic 9: Apex's Knowledge of and Interactions with Solstice Prior to Filing the Complaint
All pre-suit interactions and knowledge relating to Solstice, including without limitation:
(a) All communications, meetings, correspondence, telephone calls, emails, or other interactions between Apex (including its officers, directors, employees, agents, and outside counsel) and Solstice (including Solstice Biomedical Devices Ltd. and Solstice Biomedical, Inc.) prior to the filing of the Complaint on May 9, 2024;
(b) Any cease-and-desist letters, demand letters, licensing overtures, or other written or oral demands made by Apex to Solstice, or by Solstice to Apex, relating to the Asserted Patents, the Accused Products, or any other intellectual property matter;
(c) Apex's awareness of, monitoring of, and investigation into Solstice's products, marketing activities, regulatory filings (including FDA 510(k) submissions), trade show appearances, and entry into the United States market for laparoscopic surgical access devices;
(d) The decision-making process within Apex leading to the filing of the patent infringement Complaint, including the roles and involvement of Dr. Priya Chandrasekaran (Chief intellectual Property Officer), Martin Hale (General Counsel), and Gerald K. Whitford (Chief Executive Officer) in evaluating and approving the decision to file suit; and
(e) Any analyses, recommendations, or presentations prepared internally or by outside counsel regarding the advisability, timing, or strategy of filing suit against Solstice.
Topic 10: Assignment and Ownership of the Asserted Patents
The ownership and assignment history of the Asserted Patents, including without limitation:
(a) The chain of title and assignment history for each of the Asserted Patents (the '237 Patent, the '884 Patent, and the '105 Patent), from the named inventor, Dr. Raymond Szabo, to Apex Surgical Innovations, Inc., including all assignments, transfers, and conveyances recorded with the USPTO;
(b) Any encumbrances, security interests, pledges, liens, or third-party rights in or to the Asserted Patents, including any rights granted to lenders, investors, or other parties;
(c) Any agreements between Apex and Dr. Raymond Szabo, or between Apex and any other current or former employees, regarding the assignment of patent rights, inventions, and intellectual property, including employment agreements, invention assignment agreements, and consulting agreements;
(d) Whether any entity or person other than Apex currently holds any ownership interest, license, or other right in or to the Asserted Patents; and
(e) Apex's standing to assert the Asserted Patents in this action.
Topic 11: Apex's Document Retention and Collection Practices Relating to This Litigation
Apex's document retention, preservation, and collection practices as they relate to this litigation, including without limitation:
(a) Apex's general document retention and destruction policies and practices, including any written policies or guidelines, and the manner in which such policies are communicated to and enforced among Apex's employees, officers, and agents;
(b) The steps taken by Apex to identify, preserve, collect, review, and produce documents and electronically stored information ("ESI") responsive to Solstice's discovery requests, including Solstice's First Set of Interrogatories (fifteen (15) interrogatories) and First Set of Requests for Production of Documents (thirty-eight (38) requests) served on August 19, 2024, and Solstice's Second Set of Requests for Production of Documents served on October 14, 2024;
(c) The identity of all custodians from whom documents and ESI were collected for purposes of Apex's production of 31,450 documents bearing Bates Nos. APEX-000001 through APEX-031450, produced on October 7, 2024, including the criteria used to select such custodians;
(d) The search terms, date ranges, and other search criteria used by Apex in identifying documents responsive to Solstice's discovery requests;
(e) Any litigation hold notices issued by Apex in connection with this action, including the dates on which such notices were issued, the identity of the recipients, and the scope of the preservation obligations described therein; and
(f) Any destruction, loss, alteration, or spoliation of potentially relevant documents or data, including any failure to preserve documents or ESI that occurred after Apex reasonably anticipated this litigation.
Topic 12: Inequitable Conduct and Disclosure Obligations During Patent Prosecution
All facts relating to Solstice's counterclaim of inequitable conduct (D.I. 25, Answer and Counterclaims, filed July 29, 2024), including without limitation:
(a) The duty of candor and good faith owed by Apex and its representatives (including Dr. Raymond Szabo, as named inventor, and all patent attorneys and agents involved in the prosecution of the Asserted Patents) to the USPTO during prosecution of the Asserted Patents, as set forth in 37 C.F.R. § 1.56;
(b) The completeness and accuracy of all representations, statements, declarations, and submissions made to the USPTO during prosecution of the Asserted Patents, including the information disclosure statements filed in connection with each Asserted Patent;
(c) Any material prior art, information, or references known to Apex, its officers, the named inventor (Dr. Raymond Szabo), or Apex's patent counsel that were not disclosed to the USPTO during prosecution of any of the Asserted Patents, and the reasons, if any, for any such non-disclosure;
(d) Any internal communications, emails, memoranda, or other documents discussing whether to disclose particular prior art references or other material information to the USPTO during prosecution of the Asserted Patents;
(e) Any intent to deceive the USPTO on the part of any individual involved in the prosecution of the Asserted Patents; and
(f) Any policies or procedures maintained by Apex regarding the identification and disclosure of material prior art to the USPTO during patent prosecution.
VI. DOCUMENT REQUEST ACCOMPANYING DEPOSITION NOTICE
Pursuant to Federal Rule of Civil Procedure 30(b)(2), which permits a deposition notice to be accompanied by a request for the production of documents, Solstice hereby requests that Apex's designated witness(es) bring to the deposition any and all documents reviewed by the designee(s) in preparation for testimony that have not already been produced in this litigation. Without limiting the generality of the foregoing, Solstice specifically requests that the designee(s) bring to the deposition the following categories of documents, to the extent not already produced:
(a) All inventor notebooks, laboratory notebooks, research notes, and records of Dr. Raymond Szabo relating to the conception, development, and reduction to practice of the inventions claimed in the Asserted Patents;
(b) All executed license agreements, term sheets, and licensing correspondence relating to the Asserted Patents or any patent within the Apex Trocar Patent Family;
(c) All internal analyses, presentations, memoranda, reports, or other documents relating to the Accused Products (PrecisionEdge™ PE-5000, PE-12000, and PE-15000 Series), including any competitive analyses or product comparisons;
(d) All documents relating to Apex's damages calculations and the data underlying the expert report of Hugh Danaher, CFA, of Keystone Valuation Advisors LLC, served on February 14, 2025, including financial models, spreadsheets, data inputs, assumptions, and supporting documentation;
(e) Any documents relating to Apex's pre-suit investigation of the Accused Products, including teardown reports, testing results, photographs, and claim charts; and
(f) Any other documents reviewed by the designee(s) in preparation for testimony on any topic set forth in Section V above.
To the extent that any such documents are subject to a claim of privilege or work-product protection, Apex shall identify such documents on a privilege log in accordance with Federal Rule of Civil Procedure 26(b)(5) and the procedures established in the Joint discovery Plan.
VII. RESERVATION OF RIGHTS
Solstice expressly reserves the right to supplement or amend the topics listed in Section V of this Notice, and to add additional topics for examination, upon agreement of the parties or by leave of Court. Any such supplementation or amendment shall be without prejudice to the topics already noticed herein.
Solstice further reserves the right to depose additional officers, directors, employees, or agents of Apex on an individual basis, pursuant to Federal Rule of Civil Procedure 30(b)(1), on the topics identified herein or on any other topics relevant to the claims and defenses in this action, subject to the limitations set forth in the Federal Rules of Civil Procedure and the Scheduling Order.
This Notice is without prejudice to Solstice's right to take additional depositions of Apex or third parties as permitted by the Federal Rules of Civil Procedure, the Local Rules of the United States District Court for the District of Delaware, and the Scheduling Order entered in this action.
VIII. COMPLIANCE WITH LOCAL RULES
This Notice of Deposition is served in compliance with Local Rule 30.1 of the United States District Court for the District of Delaware, and all other applicable Local Rules governing the taking of depositions. The undersigned counsel certifies that, prior to serving this Notice, a good faith effort was made to confer with counsel for Plaintiff regarding the scheduling and logistics of the deposition, consistent with the parties' obligations under the Joint discovery Plan filed on July 15, 2024 (D.I. 42) and the Court's standing practices.
Respectfully submitted,
CALDERWOOD & HARKNESS LLP
By: ________
Marcus Delgado (Del. Bar No. 5318) Christy Bauer (Del. Bar No. 6274) Peter Vassiliev (Del. Bar No. 6890)
1201 Market Street, Suite 2500 Wilmington, Delaware 19801 Telephone: (302) 555-4200 Facsimile: (302) 555-4201
Email: mdelgado@calderwoodharkness.com
Email: cbauer@calderwoodharkness.com
Email: pvassiliev@calderwoodharkness.com
Counsel for Defendant Solstice Biomedical, Inc.
Dated: November 1, 2024
CERTIFICATE OF SERVICE
I, Christy Bauer, hereby certify that on this 1st day of November, 2024, a true and correct copy of the foregoing Defendant Solstice Biomedical, Inc.'s Notice of Deposition Pursuant to Federal Rule of Civil Procedure 30(b)(6) of Plaintiff Apex Surgical Innovations, Inc. was served upon the following counsel of record via electronic filing through the Court's CM/ECF system, which will send a Notice of Electronic Filing to all registered participants, and by email to the addresses listed below:
Victoria Stanton, Esq. Derek Loomis, Esq. Hargrove, Tate & Bennington LLP 900 North King Street, Suite 1200 Wilmington, Delaware 19801 Telephone: (302) 555-7800
Email: vstanton@htblaw.com
Email: dloomis@htblaw.com
Counsel for Plaintiff Apex Surgical Innovations, Inc.
________________________________________
Christy Bauer (Del. Bar No. 6274) CALDERWOOD & HARKNESS LLP
APEX SURGICAL INNOVATIONS, INC.,
<!-- indent:2 -->Plaintiff,<!-- /indent --> | Civil Action No. 1:24-cv-00587-RGA
v. | Chief Judge Richard G. Andrews
SOLSTICE BIOMEDICAL, INC.,
<!-- indent:2 -->Defendant.<!-- /indent -->