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

solstice-second-rfps.docx DOCUMENT Litigation

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IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE

DEFENDANT SOLSTICE BIOMEDICAL, INC.'S SECOND SET OF REQUESTS FOR PRODUCTION OF DOCUMENTS TO PLAINTIFF APEX SURGICAL INNOVATIONS, INC. (Request Nos. 39–62)

Defendant Solstice Biomedical, Inc. ("Solstice" or "Defendant"), by and through its undersigned attorneys, Calderwood & Harkness LLP, hereby propounds its Second Set of Requests for Production of Documents (Request Nos. 39 through 62) upon Plaintiff Apex Surgical Innovations, Inc. ("Apex" or "Plaintiff") pursuant to Federal Rules of Civil Procedure 26 and 34. These Requests are served following Defendant's initial review and analysis of Plaintiff's initial document production bearing Bates numbers APEX-000001 through APEX-031450, which was produced on or about October 7, 2024. That review revealed significant gaps in Apex's production, including categories of documents that were referenced in produced materials but not themselves produced, as well as categories of documents that are plainly relevant to the claims and defenses in this action but were not encompassed by Defendant's First Set of Requests for Production (Request Nos. 1–38), served on August 19, 2024. This Second Set supplements and is in addition to Defendant's First Set.

Pursuant to Federal Rule of Civil Procedure 34(b)(2)(A), Plaintiff's responses to these Requests are due within thirty (30) days of service, that is, on or before November 13, 2024. Plaintiff is requested to produce all responsive documents at the offices of Calderwood & Harkness LLP, 1201 Market Street, Suite 2500, Wilmington, Delaware 19801, or via secure electronic production in accordance with the protocols set forth in the Joint discovery Plan filed July 15, 2024 (D.I. 28).

I. DEFINITIONS

As used in these Requests, the following terms shall have the meanings set forth below:

1. "Apex" or "Plaintiff" means Apex Surgical Innovations, Inc., together with its current and former officers, directors, employees, agents, representatives, predecessors, successors, subsidiaries, and affiliates, including any divisions or business units thereof.

2. "Solstice" or "Defendant" means Solstice Biomedical, Inc. and Solstice Biomedical Devices Ltd., including their current and former officers, directors, employees, agents, representatives, subsidiaries, and affiliates.

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

4. "Licensed Patents" or "Apex Trocar Patent Family" means the fourteen (14) issued U.S. patents and six (6) pending continuation applications that are members of the patent family that includes the Asserted Patents, as identified in Exhibit A to Plaintiff's Complaint (D.I. 1) and as further described in Plaintiff's Preliminary Infringement Contentions served on September 9, 2024.

5. "Accused Products" means the PrecisionEdge™ PE-5000 Series, PE-12000 Series, and PE-15000 Series laparoscopic trocar assemblies manufactured, marketed, offered for sale, sold, imported, or used by Solstice, including all versions, variants, configurations, and components thereof.

6. "Document(s)" shall be defined broadly and to the fullest extent permitted under Federal Rule of Civil Procedure 34(a) and shall include, without limitation, all writings, drawings, graphs, charts, photographs, sound recordings, images, electronically stored information ("ESI"), and any other data or data compilations stored in any medium from which information can be obtained, either directly or, if necessary, after translation by the responding party into a reasonably usable form. The term "Document" includes, without limitation, originals, drafts, revisions, copies (whether or not identical to the original), attachments, enclosures, exhibits, and metadata associated with any of the foregoing.

7. "Communication(s)" means every manner of transmitting or exchanging information between two or more persons, whether oral, written, or electronic, including but not limited to letters, memoranda, emails, text messages (including SMS and MMS), instant messages (including messages transmitted via Northgate Data Systems, Meridian Solutions, or similar platforms), telephone calls, voicemails, video conferences, and any other form of correspondence or exchange of information.

8. "Person" means any natural person, corporation, limited liability company, partnership, joint venture, association, governmental entity, or any other form of legal entity.

9. "Relating to" or "concerning" means directly or indirectly pertaining to, referring to, describing, evidencing, constituting, reflecting, mentioning, connected with, commenting upon, responsive to, having a logical connection to, or being otherwise relevant to the subject matter in question.

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

11. "Identify" means: (a) when used with respect to a Document, to state the date of the Document, the author(s), the recipient(s) and any persons copied thereon, the subject matter or general description of the Document, the present location and custodian of the Document, and the Bates number(s) if the Document has been previously produced in this litigation; and (b) when used with respect to a Person, to state the Person's full name, current or last known title or position, current or last known employer, and current or last known mailing address, telephone number, and email address.

12. "Dr. Raymond Szabo" means Dr. Raymond A. Szabo, Vice President of Engineering at Apex Surgical Innovations, Inc., and a named inventor on each of the Asserted Patents.

13. "Dr. Priya Chandrasekaran" means Dr. Priya Chandrasekaran, Chief intellectual Property Officer at Apex Surgical Innovations, Inc.

14. "Martin Hale" means Martin R. Hale, General Counsel at Apex Surgical Innovations, Inc.

II. INSTRUCTIONS

The following instructions apply to each Request for Production set forth herein:

1. Scope of Production. All Documents responsive to these Requests should be produced in their entirety, without abbreviation, redaction, or expurgation, except as required to protect information subject to a valid claim of attorney-client privilege, work product protection, or other legally recognized privilege. Where any Document or portion thereof is withheld on the basis of privilege, Apex shall provide a privilege log in compliance with Federal Rule of Civil Procedure 26(b)(5)(A) and the requirements set forth in the Court's Scheduling Order dated July 2, 2024 (D.I. 22), including, for each withheld Document, the date of the Document, the author(s), all recipients and persons copied, the general subject matter of the Document, and the specific privilege(s) claimed. To the extent any Document contains both privileged and non-privileged information, non-privileged portions shall be produced and the redacted portions shall be identified on the privilege log.

2. Time Period. Unless otherwise specified in a particular Request, each Request covers the period from January 1, 2005 through the date of Apex's production in response to this Second Set. This time period is designed to encompass the full period of development, prosecution, and enforcement of the patents in the Apex Trocar Patent Family.

3. Format of Production. Documents shall be produced in the format specified in the Joint discovery Plan filed July 15, 2024 (D.I. 28), which provides, inter alia, that: (a) spreadsheets (including Ashbury Holdings Excel files), databases, and other structured data shall be produced in native format with all formulas, hidden columns, and linked data intact; (b) all other Documents shall be produced as single-page TIFF images (300 dpi minimum resolution) with corresponding Ashgrove Technologies- or Relativity-compatible load files (DAT, OPT, and extracted or OCR text files); (c) each page shall be endorsed with a unique, sequential Bates number; and (d) email Documents shall include all metadata fields, including sent/received dates, author/recipient fields, subject lines, and parent-child relationships between emails and their attachments.

4. Continuing Obligation. Pursuant to Federal Rule of Civil Procedure 26(e), Apex has a continuing obligation to supplement its responses and productions if and when additional responsive Documents are identified or come into Apex's possession, custody, or control. To the extent Apex identifies additional responsive Documents after its initial response to these Requests, such Documents shall be produced promptly and no later than thirty (30) days after their identification.

5. Possession, Custody, or Control. These Requests call for the production of all responsive Documents in Apex's possession, custody, or control. A Document is deemed to be within Apex's "control" if Apex has the legal right or practical ability to obtain the Document from another person or entity. Without limiting the generality of the foregoing, Apex shall produce all responsive Documents held by its agents, non-litigation attorneys (to the extent not subject to a valid privilege), consultants, independent contractors, accountants (including Creston Perry LLP), financial advisors, and any other persons or entities acting on Apex's behalf or at Apex's direction.

6. Organization of Production. In accordance with Federal Rule of Civil Procedure 34(b)(2)(E), Documents shall be produced either: (a) as they are kept in the ordinary course of business, including identification of the file folder, directory, or organizational structure from which they were collected; or (b) organized and labeled to correspond to the categories in the Requests set forth below.

7. Identification of Custodians and Sources. For each Request, Apex shall identify the custodian(s) and/or source(s) (including shared drives, databases, document management systems, and email accounts) from which responsive Documents were collected, and shall indicate if no responsive Documents were found for a particular custodian or source.

8. Objections. If Apex objects to any Request or any portion thereof, Apex shall state the objection with specificity, including the factual and legal basis for each objection, and shall nonetheless produce all Documents that are responsive to the non-objectionable portions of the Request. A general or boilerplate objection, without more, will be treated as no objection at all.

9. Interpretation. The singular shall include the plural and vice versa. The conjunctive "and" shall be construed as the disjunctive "or," and vice versa, to the extent necessary to make a Request inclusive rather than exclusive. The use of a verb in any tense shall be construed to encompass the verb in all other tenses.

III. REQUESTS FOR PRODUCTION

A. Technical Drawings, Engineering Specifications, and Design Documents

REQUEST NO. 39:

All technical drawings, engineering drawings, CAD files (including but not limited to Meridian Data Systems, Glenrock Technologies, and Strathmore Data Systems files), and design specifications relating to the locking seal assembly covered by Claims 1, 3, 7, and 12 of the '237 Patent, including but not limited to any drawings or specifications created by or under the direction of Dr. Raymond Szabo or any other engineer, designer, or technician at Apex that were not included in the prosecution file history of the '237 Patent and were not produced in Apex's initial production (APEX-000001 through APEX-031450). This Request includes, without limitation, preliminary concept sketches, feasibility studies, tolerance analyses, material specifications, assembly instructions, and bills of materials relating to the locking seal assembly and its component parts.

REQUEST NO. 40:

All technical drawings, engineering drawings, CAD files (including but not limited to Meridian Data Systems, Glenrock Technologies, and Strathmore Data Systems files), and design specifications relating to the retractable blade deployment mechanism covered by Claims 1, 2, 5, 9, and 14 of the '884 Patent, including but not limited to prototype drawings, engineering change orders ("ECOs"), design revision histories, engineering change notices ("ECNs"), and any drawings or specifications reflecting the evolution of the retractable blade deployment mechanism from initial concept through final production design. This Request encompasses all versions, iterations, and revisions of such drawings and specifications, regardless of whether they depict the embodiment ultimately claimed in the '884 Patent or alternative embodiments that were considered but not pursued.

REQUEST NO. 41:

All technical drawings, engineering drawings, CAD files (including but not limited to Meridian Data Systems, Glenrock Technologies, and Strathmore Data Systems files), and design specifications relating to the integrated insufflation valve and seal covered by Claims 1, 4, and 8 of the '105 Patent, including but not limited to any drawings depicting alternative embodiments, design iterations, or design variations not depicted in the patent figures of the '105 Patent. This Request further encompasses drawings and specifications reflecting the structural relationship between the insufflation valve and the seal components, including any functional testing configurations, dimensional analyses, and tolerance stack-up analyses.

REQUEST NO. 42:

All Documents reflecting or relating to engineering or design testing of the locking seal assembly (as described in the '237 Patent), the retractable blade deployment mechanism (as described in the '884 Patent), and/or the integrated insufflation valve and seal (as described in the '105 Patent), including but not limited to test protocols, test plans, test matrices, test results, raw data, analyzed data, performance data, bench testing reports, simulated-use testing reports, cadaveric testing reports, clinical evaluation reports, failure mode and effects analyses ("FMEAs"), failure analyses, root cause analyses, quality assurance reports, design verification and validation reports, and any corrective and preventive action ("CAPA") records arising from testing of the foregoing assemblies or mechanisms.

B. Design-Around Analyses and Competitive intelligence

REQUEST NO. 43:

All Documents constituting, reflecting, or relating to any design-around analysis, design-around study, design-around effort, or design-around project conducted by or on behalf of Apex with respect to any prior art references identified during prosecution of the Asserted Patents or in connection with any third-party products in the field of laparoscopic surgical access devices, including but not limited to analyses of products manufactured, sold, or offered for sale by Solstice or any other competitor. This Request encompasses internal memoranda, presentations, reports, consultant reports, patent landscape analyses, and any other Documents reflecting Apex's consideration of whether or how to design around existing patents, prior art, or competing products.

REQUEST NO. 44:

All Documents constituting, reflecting, or relating to any competitive analysis, competitive intelligence reports, market studies, market share analyses, or benchmarking studies prepared by or for Apex that reference, discuss, compare, or evaluate the Accused Products (PrecisionEdge™ PE-5000 Series, PE-12000 Series, and/or PE-15000 Series) relative to Apex's own products or to any products of third parties in the field of laparoscopic trocar systems and surgical access devices. This Request includes, without limitation, marketing research, product comparison charts, win/loss analyses, trade show reports, customer feedback summaries, and any reports or analyses prepared by external consultants, market research firms, or Apex's sales and marketing teams.

REQUEST NO. 45:

All Documents constituting, reflecting, or relating to any analysis by Apex of Solstice's patent portfolio, product designs, product specifications, or technology, including but not limited to any freedom-to-operate opinions, right-to-use opinions, infringement analyses, non-infringement assessments, invalidity analyses, or patentability analyses prepared by or for Apex (whether by in-house counsel, outside counsel, patent agents, or consultants) concerning any of Solstice's products, patents, or patent applications. To the extent Apex claims that any responsive Document is privileged, Apex shall include such Document on its privilege log with sufficient detail to permit Defendant to assess the claim of privilege.

C. Licensing Agreements and Negotiations

REQUEST NO. 46:

All fully executed license agreements, settlement agreements, covenants not to sue, consent judgments, and releases between Apex and any third party relating to any patent in the Apex Trocar Patent Family, including but not limited to agreements relating to the '237 Patent, the '884 Patent, or the '105 Patent. This Request encompasses the complete agreements, including all exhibits, schedules, amendments, addenda, side letters, and any related term sheets or memoranda of understanding, regardless of whether such agreements are currently in effect, have expired, or have been terminated.

REQUEST NO. 47:

All Documents constituting, reflecting, or relating to negotiations with any third party for a license, sublicense, cross-license, or other rights under any patent in the Apex Trocar Patent Family, including but not limited to term sheets, proposals, counterproposals, draft agreements, redline comparisons of draft agreements, correspondence (whether by letter, email, or other medium), meeting agendas and notes, and internal Apex memoranda, presentations, or analyses prepared in connection with such negotiations. This Request specifically targets Documents not produced in Apex's initial production (APEX-000001 through APEX-031450) that Defendant has reason to believe exist based on references to licensing discussions and negotiation activities identified in produced Documents, including but not limited to references in APEX-012874 (email from M. Hale referencing "the Marlowe Asset Management license terms"), APEX-015230 (memorandum discussing "third-party licensing opportunities"), and APEX-022691 (presentation slide referencing "licensing pipeline" and identifying five prospective licensees by name).

REQUEST NO. 48:

All Documents reflecting the financial terms of any license granted by Apex under any patent in the Apex Trocar Patent Family, including but not limited to royalty rates (whether running royalties, lump-sum royalties, or a combination thereof), lump-sum payments, upfront fees, milestone payments, minimum annual royalties, paid-up license fees, and any amendments, modifications, or renegotiations of such financial terms. This Request includes any royalty rate schedules, royalty calculation methodologies, and any internal analyses or valuations prepared by Apex in connection with setting or negotiating royalty rates for the Licensed Patents.

REQUEST NO. 49:

All Documents constituting, reflecting, or relating to any demand letters, cease-and-desist letters, notice letters, invitation-to-license letters, or other pre-litigation correspondence sent by or on behalf of Apex to any third party alleging or suggesting infringement of any patent in the Apex Trocar Patent Family, including any responses received from such third parties and any internal Apex memoranda, analyses, or discussions relating to the decision to send such correspondence.

D. Inventor Notebooks, Conception, and Reduction to Practice

REQUEST NO. 50:

All inventor notebooks, laboratory notebooks, research journals, and engineering logbooks maintained by Dr. Raymond Szabo or any other individual involved in the conception, development, and/or reduction to practice of the inventions claimed in the Asserted Patents, to the extent such materials were not included in Apex's initial production. Defendant's review of the initial production indicates that inventor notebooks were produced only for the period from March 2014 through June 2016, and only for Dr. Szabo (Bates Nos. APEX-024100 through APEX-025899). Defendant hereby requests production of notebooks, journals, and logbooks covering the full period of development from January 2005 through the filing dates of the respective patent applications, including but not limited to notebooks maintained by Dr. Szabo, Dr. Priya Chandrasekaran, and any other engineers, scientists, or technicians at Apex who contributed to the conception or reduction to practice of the claimed inventions.

REQUEST NO. 51:

All Documents relating to the conception, development, and reduction to practice of the inventions claimed in the '105 Patent (U.S. Patent No. 10,932,105), including but not limited to: (a) communications between or among Dr. Raymond Szabo, Dr. Priya Chandrasekaran, and any other Apex employees, contractors, or consultants relating to the design, development, and testing of the integrated insufflation valve and seal system; (b) invention disclosure forms or records submitted in connection with the inventions of the '105 Patent; (c) records of internal invention review committee meetings at which the '105 Patent inventions were discussed or evaluated; and (d) any Documents relating to the identification and evaluation of the named inventors of the '105 Patent, including any analyses of inventorship conducted by Apex or its patent prosecution counsel.

E. Prior Art and Prosecution-Related Documents

REQUEST NO. 52:

All Documents constituting, reflecting, or relating to any prior art search conducted by or on behalf of Apex at any time relating to the subject matter of the Asserted Patents, including but not limited to search reports, search summaries, lists of prior art references identified, prior art databases queried (including patent databases, technical literature databases, and product databases), search terms and search strategies used, and results obtained, other than materials that were submitted to the U.S. Patent and Trademark Office during prosecution of the Asserted Patents and that were already produced as part of the prosecution file histories in Apex's initial production. This Request encompasses prior art searches conducted by Apex's in-house IP team, outside patent prosecution counsel, outside search firms, or any other person or entity acting at Apex's direction, regardless of whether the search was conducted before, during, or after prosecution of the Asserted Patents.

REQUEST NO. 53:

All Documents constituting, reflecting, or relating to any communication between Apex (including its in-house and outside patent prosecution counsel) and the U.S. Patent and Trademark Office that is not contained in the publicly available prosecution file histories of the Asserted Patents, including but not limited to: (a) interview summaries, examiner interview request forms, and any notes or memoranda prepared in connection with examiner interviews; (b) supplemental information disclosure statements filed after issuance of the respective patents; (c) after-final communications, including any advisory actions; (d) any pre-appeal brief conference requests or decisions; and (e) any petitions filed with the USPTO relating to the Asserted Patents (including petitions to make special, petitions to revive, or petitions for extension of time).

REQUEST NO. 54:

All Documents relating to any inter partes review ("IPR"), post-grant review ("PGR"), ex parte reexamination, supplemental examination, or other post-issuance proceeding before the U.S. Patent and Trademark Office, the Patent Trial and Appeal Board, or any foreign patent office involving any patent in the Apex Trocar Patent Family, including but not limited to: (a) petitions for institution (whether filed by Apex or by any third party); (b) preliminary responses; (c) institution decisions; (d) patent owner responses; (e) reply briefs; (f) motions; (g) oral hearing transcripts; (h) final written decisions; (i) any settlement agreements or stipulations filed in connection with such proceedings; and (j) any related appellate proceedings before the U.S. Court of Appeals for the Federal Circuit.

F. Damages-Related Documents

REQUEST NO. 55:

All Documents constituting, reflecting, or relating to Apex's revenue, cost of goods sold, gross profit, gross margin, net profit, and net margin for products that compete with, are comparable to, or are asserted to practice the inventions claimed in the Asserted Patents, for each fiscal year from 2019 through the present, including but not limited to internal financial reports, management reports, segment reports, product-line reports, profit-and-loss statements, variance analyses, budget-to-actual reports, and presentations to Apex's board of directors, executive committee, or senior management. Without limitation, this Request covers all products in Apex's trocar systems and surgical access devices product lines, including any products marketed under the TrocarVault™, SealLock™, and ApexAccess™ brand names, as well as any other branded or unbranded trocar products sold by Apex.

REQUEST NO. 56:

All Documents provided to, relied upon by, considered by, or reviewed by Hugh Danaher, CFA, of Keystone Valuation Advisors LLC, in connection with his preparation of the damages analysis or damages report in this matter, to the extent not previously produced in Apex's initial production, including but not limited to: (a) financial data, including revenue data, cost data, and profitability data provided by Apex or its counsel; (b) market reports, industry reports, and market research data; (c) comparable license analyses, including any analyses of royalty rates in comparable license agreements; (d) communications between Mr. Danaher and Apex or its counsel at Hargrove, Tate & Bennington LLP, to the extent not protected by work product or other privilege; (e) draft reports, draft analyses, or preliminary calculations prepared by Mr. Danaher or his firm; and (f) any workpapers, spreadsheets, or databases created or maintained by Mr. Danaher or his firm in connection with this engagement.

REQUEST NO. 57:

All Documents constituting, reflecting, or relating to any royalty or other payments received by Apex under any license agreement for any patent in the Apex Trocar Patent Family, including but not limited to royalty reports submitted by licensees, payment records, wire transfer confirmations, invoices, accounts receivable records, royalty audit reports, and any correspondence between Apex and its licensees regarding the calculation, payment, or dispute of royalty amounts.

REQUEST NO. 58:

All Documents constituting, reflecting, or relating to any valuation, appraisal, or economic analysis of the Asserted Patents or the Apex Trocar Patent Family prepared by or for Apex at any time, including but not limited to: (a) valuations or appraisals prepared by Apex's auditors, Creston Perry LLP, for purposes of financial reporting (including ASC 805 or ASC 350 analyses); (b) valuations or analyses prepared by any financial advisors, investment bankers, or economic consultants in connection with asset valuation, portfolio management, or strategic planning; (c) valuations or analyses prepared in connection with any acquisition, merger, divestiture, or other corporate transaction involving Apex or its patent portfolio; and (d) any internal analyses prepared by Apex's IP department, finance department, or business development team regarding the monetary value, revenue-generating potential, or strategic significance of the Asserted Patents or the Apex Trocar Patent Family.

G. Communications Regarding Solstice and the Accused Products

REQUEST NO. 59:

All internal Apex Communications (including but not limited to emails, memoranda, instant messages transmitted via Meridian Solutions, Northgate Data Systems, or similar platforms, and presentations) that reference, discuss, or relate to Solstice Biomedical Devices Ltd., Solstice Biomedical, Inc., or any of the Accused Products (PrecisionEdge™ PE-5000 Series, PE-12000 Series, or PE-15000 Series), to the extent such Communications were not already produced in Apex's initial production (APEX-000001 through APEX-031450). This Request is intended to capture Communications that may have been excluded from the initial production due to the search terms, date ranges, or custodians used in Apex's initial collection and review, and is made in light of Defendant's identification of at least seven (7) produced Documents that reference additional Communications with or about Solstice that were not themselves produced.

REQUEST NO. 60:

All Communications between Apex and any third party — including but not limited to customers, distributors, group purchasing organizations, hospital systems, ambulatory surgical centers, surgeons, healthcare providers, and medical device consultants — that reference, discuss, compare, evaluate, or otherwise relate to the Accused Products (PrecisionEdge™ PE-5000 Series, PE-12000 Series, or PE-15000 Series) in relation to Apex's products or any products of third parties in the field of laparoscopic surgical access devices.

H. Regulatory Filings and Product Approvals

REQUEST NO. 61:

All Documents constituting, reflecting, or relating to any 510(k) premarket notification submissions, premarket approval ("PMA") applications, investigational device exemption ("IDE") applications, de novo classification requests, or other regulatory filings submitted by Apex to the U.S. Food and Drug Administration ("FDA") relating to Apex's trocar systems and surgical access devices that are alleged or claimed to practice the inventions claimed in the Asserted Patents, including but not limited to: (a) 510(k) summary documents or statements; (b) technical summaries, including descriptions of the device, intended use, and technological characteristics; (c) predicate device analyses and substantial equivalence determinations; (d) performance data submitted to the FDA; (e) FDA clearance letters, approval letters, and any conditions of approval; and (f) any post-market surveillance reports, medical device reports ("MDRs"), or recall notifications relating to such products.

I. Corporate Transactions and Patent Assignment

REQUEST NO. 62:

All Documents constituting, reflecting, or relating to any assignment, transfer, encumbrance, security interest, pledge, mortgage, lien, or other disposition of any rights (including any partial, exclusive, or non-exclusive rights) in any patent or patent application in the Apex Trocar Patent Family, including but not limited to: (a) assignment agreements between inventors and Apex or any predecessor entity; (b) assignments recorded with the U.S. Patent and Trademark Office; (c) chain-of-title documents; (d) security agreements or intellectual property security agreements pursuant to which any patent in the Apex Trocar Patent Family was pledged as collateral; (e) any documents reflecting that any entity or person other than Apex holds, has held, or claims to hold any ownership interest, co-ownership interest, or exclusive license in any of the Asserted Patents; and (f) any documents relating to due diligence investigations of the ownership or chain of title of the Asserted Patents conducted by or on behalf of Apex, its lenders, or potential acquirers.

IV. RESERVATION OF RIGHTS

Solstice reserves the right to serve additional requests for production of documents and other written discovery as permitted by the Federal Rules of Civil Procedure, the Court's Scheduling Order dated July 2, 2024 (D.I. 22), and the Joint discovery Plan filed July 15, 2024 (D.I. 28). Nothing in these Requests shall be construed as a waiver of Solstice's right to propound additional or supplemental discovery requests, nor as an acknowledgment that these Requests encompass all categories of documents relevant to the claims and defenses in this action.

Solstice further reserves the right to supplement, amend, or modify these Requests based on its ongoing review of Apex's document productions, deposition testimony, and other discovery obtained in this matter, including but not limited to documents and information produced by third parties in response to subpoenas issued pursuant to Federal Rule of Civil Procedure 45.

\ \ \*

Respectfully submitted,

CALDERWOOD & HARKNESS LLP

By: ________

Marcus J. Delgado (Del. Bar No. 5847) mdelgado@calderwoodharkness.com

Christy A. Bauer (Del. Bar No. 6312) cbauer@calderwoodharkness.com

Peter D. Vassiliev (Del. Bar No. 6789) pvassiliev@calderwoodharkness.com

CALDERWOOD & HARKNESS LLP 1201 Market Street, Suite 2500 Wilmington, Delaware 19801 Telephone: (302) 555-4100 Facsimile: (302) 555-4101

Attorneys for Defendant Solstice Biomedical, Inc.

Dated: October 14, 2024

CERTIFICATE OF SERVICE

I, Christy A. Bauer, hereby certify that on October 14, 2024, a true and correct copy of Defendant Solstice Biomedical, Inc.'s Second Set of Requests for Production of Documents to Plaintiff Apex Surgical Innovations, Inc. (Nos. 39–62) was served upon the following counsel of record via the Court's CM/ECF electronic filing system, which will send a Notice of Electronic Filing to all registered participants, and by email to:

Victoria R. Stanton, Esq. vstanton@htblaw.com

Derek M. Loomis, Esq. dloomis@htblaw.com

HARGROVE, TATE & BENNINGTON LLP 900 North King Street, Suite 1200 Wilmington, Delaware 19801 Telephone: (302) 555-7800 Facsimile: (302) 555-7801

Counsel for Plaintiff Apex Surgical Innovations, Inc.

________________________________________

Christy A. Bauer (Del. Bar No. 6312) 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.

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE
DEFENDANT SOLSTICE BIOMEDICAL, INC.'S SECOND SET OF REQUESTS FOR PRODUCTION OF DOCUMENTS TO PLAINTIFF APEX SURGICAL INNOVATIONS, INC. (Request Nos. 39–62)
Defendant Solstice Biomedical, Inc. ("Solstice" or "Defendant"), by and through its undersigned attorneys, Calderwood & Harkness LLP, hereby propounds its Second Set of Requests for Production of Documents (Request Nos. 39 through 62) upon Plaintiff Apex Surgical Innovations, Inc. ("Apex" or "Plaintiff") pursuant to Federal Rules of Civil Procedure 26 and 34. These Requests are served following Defendant's initial review and analysis of Plaintiff's initial document production bearing Bates numbers APEX-000001 through APEX-031450, which was produced on or about October 7, 2024. That review revealed significant gaps in Apex's production, including categories of documents that were referenced in produced materials but not themselves produced, as well as categories of documents that are plainly relevant to the claims and defenses in this action but were not encompassed by Defendant's First Set of Requests for Production (Request Nos. 1–38), served on August 19, 2024. This Second Set supplements and is in addition to Defendant's First Set.
Pursuant to Federal Rule of Civil Procedure 34(b)(2)(A), Plaintiff's responses to these Requests are due within thirty (30) days of service, that is, on or before November 13, 2024. Plaintiff is requested to produce all responsive documents at the offices of Calderwood & Harkness LLP, 1201 Market Street, Suite 2500, Wilmington, Delaware 19801, or via secure electronic production in accordance with the protocols set forth in the Joint discovery Plan filed July 15, 2024 (D.I. 28).
I. DEFINITIONS
As used in these Requests, the following terms shall have the meanings set forth below:
1. "Apex" or "Plaintiff" means Apex Surgical Innovations, Inc., together with its current and former officers, directors, employees, agents, representatives, predecessors, successors, subsidiaries, and affiliates, including any divisions or business units thereof.
2. "Solstice" or "Defendant" means Solstice Biomedical, Inc. and Solstice Biomedical Devices Ltd., including their current and former officers, directors, employees, agents, representatives, subsidiaries, and affiliates.
3. "Asserted Patents" means (a) U.S. Patent No. 9,814,237 (referred to herein as "the '237 Patent"), entitled "Locking Seal Assembly for Minimally Invasive Surgical Access Device"; (b) U.S. Patent No. 10,271,884 (referred to herein as "the '884 Patent"), entitled "Retractable Blade Deployment Mechanism for Laparoscopic Trocar"; and (c) U.S. Patent No. 10,932,105 (referred to herein as "the '105 Patent"), entitled "Integrated Insufflation Valve and Seal System for Surgical Trocar."
4. "Licensed Patents" or "Apex Trocar Patent Family" means the fourteen (14) issued U.S. patents and six (6) pending continuation applications that are members of the patent family that includes the Asserted Patents, as identified in Exhibit A to Plaintiff's Complaint (D.I. 1) and as further described in Plaintiff's Preliminary Infringement Contentions served on September 9, 2024.
5. "Accused Products" means the PrecisionEdge™ PE-5000 Series, PE-12000 Series, and PE-15000 Series laparoscopic trocar assemblies manufactured, marketed, offered for sale, sold, imported, or used by Solstice, including all versions, variants, configurations, and components thereof.
6. "Document(s)" shall be defined broadly and to the fullest extent permitted under Federal Rule of Civil Procedure 34(a) and shall include, without limitation, all writings, drawings, graphs, charts, photographs, sound recordings, images, electronically stored information ("ESI"), and any other data or data compilations stored in any medium from which information can be obtained, either directly or, if necessary, after translation by the responding party into a reasonably usable form. The term "Document" includes, without limitation, originals, drafts, revisions, copies (whether or not identical to the original), attachments, enclosures, exhibits, and metadata associated with any of the foregoing.
7. "Communication(s)" means every manner of transmitting or exchanging information between two or more persons, whether oral, written, or electronic, including but not limited to letters, memoranda, emails, text messages (including SMS and MMS), instant messages (including messages transmitted via Northgate Data Systems, Meridian Solutions, or similar platforms), telephone calls, voicemails, video conferences, and any other form of correspondence or exchange of information.
8. "Person" means any natural person, corporation, limited liability company, partnership, joint venture, association, governmental entity, or any other form of legal entity.
9. "Relating to" or "concerning" means directly or indirectly pertaining to, referring to, describing, evidencing, constituting, reflecting, mentioning, connected with, commenting upon, responsive to, having a logical connection to, or being otherwise relevant to the subject matter in question.
10. "You" or "Your" means Apex Surgical Innovations, Inc., as defined in Paragraph 1 above.
11. "Identify" means: (a) when used with respect to a Document, to state the date of the Document, the author(s), the recipient(s) and any persons copied thereon, the subject matter or general description of the Document, the present location and custodian of the Document, and the Bates number(s) if the Document has been previously produced in this litigation; and (b) when used with respect to a Person, to state the Person's full name, current or last known title or position, current or last known employer, and current or last known mailing address, telephone number, and email address.
12. "Dr. Raymond Szabo" means Dr. Raymond A. Szabo, Vice President of Engineering at Apex Surgical Innovations, Inc., and a named inventor on each of the Asserted Patents.
13. "Dr. Priya Chandrasekaran" means Dr. Priya Chandrasekaran, Chief intellectual Property Officer at Apex Surgical Innovations, Inc.
14. "Martin Hale" means Martin R. Hale, General Counsel at Apex Surgical Innovations, Inc.
II. INSTRUCTIONS
The following instructions apply to each Request for Production set forth herein:
1. Scope of Production. All Documents responsive to these Requests should be produced in their entirety, without abbreviation, redaction, or expurgation, except as required to protect information subject to a valid claim of attorney-client privilege, work product protection, or other legally recognized privilege. Where any Document or portion thereof is withheld on the basis of privilege, Apex shall provide a privilege log in compliance with Federal Rule of Civil Procedure 26(b)(5)(A) and the requirements set forth in the Court's Scheduling Order dated July 2, 2024 (D.I. 22), including, for each withheld Document, the date of the Document, the author(s), all recipients and persons copied, the general subject matter of the Document, and the specific privilege(s) claimed. To the extent any Document contains both privileged and non-privileged information, non-privileged portions shall be produced and the redacted portions shall be identified on the privilege log.
2. Time Period. Unless otherwise specified in a particular Request, each Request covers the period from January 1, 2005 through the date of Apex's production in response to this Second Set. This time period is designed to encompass the full period of development, prosecution, and enforcement of the patents in the Apex Trocar Patent Family.
3. Format of Production. Documents shall be produced in the format specified in the Joint discovery Plan filed July 15, 2024 (D.I. 28), which provides, inter alia, that: (a) spreadsheets (including Ashbury Holdings Excel files), databases, and other structured data shall be produced in native format with all formulas, hidden columns, and linked data intact; (b) all other Documents shall be produced as single-page TIFF images (300 dpi minimum resolution) with corresponding Ashgrove Technologies- or Relativity-compatible load files (DAT, OPT, and extracted or OCR text files); (c) each page shall be endorsed with a unique, sequential Bates number; and (d) email Documents shall include all metadata fields, including sent/received dates, author/recipient fields, subject lines, and parent-child relationships between emails and their attachments.
4. Continuing Obligation. Pursuant to Federal Rule of Civil Procedure 26(e), Apex has a continuing obligation to supplement its responses and productions if and when additional responsive Documents are identified or come into Apex's possession, custody, or control. To the extent Apex identifies additional responsive Documents after its initial response to these Requests, such Documents shall be produced promptly and no later than thirty (30) days after their identification.
5. Possession, Custody, or Control. These Requests call for the production of all responsive Documents in Apex's possession, custody, or control. A Document is deemed to be within Apex's "control" if Apex has the legal right or practical ability to obtain the Document from another person or entity. Without limiting the generality of the foregoing, Apex shall produce all responsive Documents held by its agents, non-litigation attorneys (to the extent not subject to a valid privilege), consultants, independent contractors, accountants (including Creston Perry LLP), financial advisors, and any other persons or entities acting on Apex's behalf or at Apex's direction.
6. Organization of Production. In accordance with Federal Rule of Civil Procedure 34(b)(2)(E), Documents shall be produced either: (a) as they are kept in the ordinary course of business, including identification of the file folder, directory, or organizational structure from which they were collected; or (b) organized and labeled to correspond to the categories in the Requests set forth below.
7. Identification of Custodians and Sources. For each Request, Apex shall identify the custodian(s) and/or source(s) (including shared drives, databases, document management systems, and email accounts) from which responsive Documents were collected, and shall indicate if no responsive Documents were found for a particular custodian or source.
8. Objections. If Apex objects to any Request or any portion thereof, Apex shall state the objection with specificity, including the factual and legal basis for each objection, and shall nonetheless produce all Documents that are responsive to the non-objectionable portions of the Request. A general or boilerplate objection, without more, will be treated as no objection at all.
9. Interpretation. The singular shall include the plural and vice versa. The conjunctive "and" shall be construed as the disjunctive "or," and vice versa, to the extent necessary to make a Request inclusive rather than exclusive. The use of a verb in any tense shall be construed to encompass the verb in all other tenses.
III. REQUESTS FOR PRODUCTION
A. Technical Drawings, Engineering Specifications, and Design Documents
REQUEST NO. 39:
All technical drawings, engineering drawings, CAD files (including but not limited to Meridian Data Systems, Glenrock Technologies, and Strathmore Data Systems files), and design specifications relating to the locking seal assembly covered by Claims 1, 3, 7, and 12 of the '237 Patent, including but not limited to any drawings or specifications created by or under the direction of Dr. Raymond Szabo or any other engineer, designer, or technician at Apex that were not included in the prosecution file history of the '237 Patent and were not produced in Apex's initial production (APEX-000001 through APEX-031450). This Request includes, without limitation, preliminary concept sketches, feasibility studies, tolerance analyses, material specifications, assembly instructions, and bills of materials relating to the locking seal assembly and its component parts.
REQUEST NO. 40:
All technical drawings, engineering drawings, CAD files (including but not limited to Meridian Data Systems, Glenrock Technologies, and Strathmore Data Systems files), and design specifications relating to the retractable blade deployment mechanism covered by Claims 1, 2, 5, 9, and 14 of the '884 Patent, including but not limited to prototype drawings, engineering change orders ("ECOs"), design revision histories, engineering change notices ("ECNs"), and any drawings or specifications reflecting the evolution of the retractable blade deployment mechanism from initial concept through final production design. This Request encompasses all versions, iterations, and revisions of such drawings and specifications, regardless of whether they depict the embodiment ultimately claimed in the '884 Patent or alternative embodiments that were considered but not pursued.
REQUEST NO. 41:
All technical drawings, engineering drawings, CAD files (including but not limited to Meridian Data Systems, Glenrock Technologies, and Strathmore Data Systems files), and design specifications relating to the integrated insufflation valve and seal covered by Claims 1, 4, and 8 of the '105 Patent, including but not limited to any drawings depicting alternative embodiments, design iterations, or design variations not depicted in the patent figures of the '105 Patent. This Request further encompasses drawings and specifications reflecting the structural relationship between the insufflation valve and the seal components, including any functional testing configurations, dimensional analyses, and tolerance stack-up analyses.
REQUEST NO. 42:
All Documents reflecting or relating to engineering or design testing of the locking seal assembly (as described in the '237 Patent), the retractable blade deployment mechanism (as described in the '884 Patent), and/or the integrated insufflation valve and seal (as described in the '105 Patent), including but not limited to test protocols, test plans, test matrices, test results, raw data, analyzed data, performance data, bench testing reports, simulated-use testing reports, cadaveric testing reports, clinical evaluation reports, failure mode and effects analyses ("FMEAs"), failure analyses, root cause analyses, quality assurance reports, design verification and validation reports, and any corrective and preventive action ("CAPA") records arising from testing of the foregoing assemblies or mechanisms.
B. Design-Around Analyses and Competitive intelligence
REQUEST NO. 43:
All Documents constituting, reflecting, or relating to any design-around analysis, design-around study, design-around effort, or design-around project conducted by or on behalf of Apex with respect to any prior art references identified during prosecution of the Asserted Patents or in connection with any third-party products in the field of laparoscopic surgical access devices, including but not limited to analyses of products manufactured, sold, or offered for sale by Solstice or any other competitor. This Request encompasses internal memoranda, presentations, reports, consultant reports, patent landscape analyses, and any other Documents reflecting Apex's consideration of whether or how to design around existing patents, prior art, or competing products.
REQUEST NO. 44:
All Documents constituting, reflecting, or relating to any competitive analysis, competitive intelligence reports, market studies, market share analyses, or benchmarking studies prepared by or for Apex that reference, discuss, compare, or evaluate the Accused Products (PrecisionEdge™ PE-5000 Series, PE-12000 Series, and/or PE-15000 Series) relative to Apex's own products or to any products of third parties in the field of laparoscopic trocar systems and surgical access devices. This Request includes, without limitation, marketing research, product comparison charts, win/loss analyses, trade show reports, customer feedback summaries, and any reports or analyses prepared by external consultants, market research firms, or Apex's sales and marketing teams.
REQUEST NO. 45:
All Documents constituting, reflecting, or relating to any analysis by Apex of Solstice's patent portfolio, product designs, product specifications, or technology, including but not limited to any freedom-to-operate opinions, right-to-use opinions, infringement analyses, non-infringement assessments, invalidity analyses, or patentability analyses prepared by or for Apex (whether by in-house counsel, outside counsel, patent agents, or consultants) concerning any of Solstice's products, patents, or patent applications. To the extent Apex claims that any responsive Document is privileged, Apex shall include such Document on its privilege log with sufficient detail to permit Defendant to assess the claim of privilege.
C. Licensing Agreements and Negotiations
REQUEST NO. 46:
All fully executed license agreements, settlement agreements, covenants not to sue, consent judgments, and releases between Apex and any third party relating to any patent in the Apex Trocar Patent Family, including but not limited to agreements relating to the '237 Patent, the '884 Patent, or the '105 Patent. This Request encompasses the complete agreements, including all exhibits, schedules, amendments, addenda, side letters, and any related term sheets or memoranda of understanding, regardless of whether such agreements are currently in effect, have expired, or have been terminated.
REQUEST NO. 47:
All Documents constituting, reflecting, or relating to negotiations with any third party for a license, sublicense, cross-license, or other rights under any patent in the Apex Trocar Patent Family, including but not limited to term sheets, proposals, counterproposals, draft agreements, redline comparisons of draft agreements, correspondence (whether by letter, email, or other medium), meeting agendas and notes, and internal Apex memoranda, presentations, or analyses prepared in connection with such negotiations. This Request specifically targets Documents not produced in Apex's initial production (APEX-000001 through APEX-031450) that Defendant has reason to believe exist based on references to licensing discussions and negotiation activities identified in produced Documents, including but not limited to references in APEX-012874 (email from M. Hale referencing "the Marlowe Asset Management license terms"), APEX-015230 (memorandum discussing "third-party licensing opportunities"), and APEX-022691 (presentation slide referencing "licensing pipeline" and identifying five prospective licensees by name).
REQUEST NO. 48:
All Documents reflecting the financial terms of any license granted by Apex under any patent in the Apex Trocar Patent Family, including but not limited to royalty rates (whether running royalties, lump-sum royalties, or a combination thereof), lump-sum payments, upfront fees, milestone payments, minimum annual royalties, paid-up license fees, and any amendments, modifications, or renegotiations of such financial terms. This Request includes any royalty rate schedules, royalty calculation methodologies, and any internal analyses or valuations prepared by Apex in connection with setting or negotiating royalty rates for the Licensed Patents.
REQUEST NO. 49:
All Documents constituting, reflecting, or relating to any demand letters, cease-and-desist letters, notice letters, invitation-to-license letters, or other pre-litigation correspondence sent by or on behalf of Apex to any third party alleging or suggesting infringement of any patent in the Apex Trocar Patent Family, including any responses received from such third parties and any internal Apex memoranda, analyses, or discussions relating to the decision to send such correspondence.
D. Inventor Notebooks, Conception, and Reduction to Practice
REQUEST NO. 50:
All inventor notebooks, laboratory notebooks, research journals, and engineering logbooks maintained by Dr. Raymond Szabo or any other individual involved in the conception, development, and/or reduction to practice of the inventions claimed in the Asserted Patents, to the extent such materials were not included in Apex's initial production. Defendant's review of the initial production indicates that inventor notebooks were produced only for the period from March 2014 through June 2016, and only for Dr. Szabo (Bates Nos. APEX-024100 through APEX-025899). Defendant hereby requests production of notebooks, journals, and logbooks covering the full period of development from January 2005 through the filing dates of the respective patent applications, including but not limited to notebooks maintained by Dr. Szabo, Dr. Priya Chandrasekaran, and any other engineers, scientists, or technicians at Apex who contributed to the conception or reduction to practice of the claimed inventions.
REQUEST NO. 51:
All Documents relating to the conception, development, and reduction to practice of the inventions claimed in the '105 Patent (U.S. Patent No. 10,932,105), including but not limited to: (a) communications between or among Dr. Raymond Szabo, Dr. Priya Chandrasekaran, and any other Apex employees, contractors, or consultants relating to the design, development, and testing of the integrated insufflation valve and seal system; (b) invention disclosure forms or records submitted in connection with the inventions of the '105 Patent; (c) records of internal invention review committee meetings at which the '105 Patent inventions were discussed or evaluated; and (d) any Documents relating to the identification and evaluation of the named inventors of the '105 Patent, including any analyses of inventorship conducted by Apex or its patent prosecution counsel.
E. Prior Art and Prosecution-Related Documents
REQUEST NO. 52:
All Documents constituting, reflecting, or relating to any prior art search conducted by or on behalf of Apex at any time relating to the subject matter of the Asserted Patents, including but not limited to search reports, search summaries, lists of prior art references identified, prior art databases queried (including patent databases, technical literature databases, and product databases), search terms and search strategies used, and results obtained, other than materials that were submitted to the U.S. Patent and Trademark Office during prosecution of the Asserted Patents and that were already produced as part of the prosecution file histories in Apex's initial production. This Request encompasses prior art searches conducted by Apex's in-house IP team, outside patent prosecution counsel, outside search firms, or any other person or entity acting at Apex's direction, regardless of whether the search was conducted before, during, or after prosecution of the Asserted Patents.
REQUEST NO. 53:
All Documents constituting, reflecting, or relating to any communication between Apex (including its in-house and outside patent prosecution counsel) and the U.S. Patent and Trademark Office that is not contained in the publicly available prosecution file histories of the Asserted Patents, including but not limited to: (a) interview summaries, examiner interview request forms, and any notes or memoranda prepared in connection with examiner interviews; (b) supplemental information disclosure statements filed after issuance of the respective patents; (c) after-final communications, including any advisory actions; (d) any pre-appeal brief conference requests or decisions; and (e) any petitions filed with the USPTO relating to the Asserted Patents (including petitions to make special, petitions to revive, or petitions for extension of time).
REQUEST NO. 54:
All Documents relating to any inter partes review ("IPR"), post-grant review ("PGR"), ex parte reexamination, supplemental examination, or other post-issuance proceeding before the U.S. Patent and Trademark Office, the Patent Trial and Appeal Board, or any foreign patent office involving any patent in the Apex Trocar Patent Family, including but not limited to: (a) petitions for institution (whether filed by Apex or by any third party); (b) preliminary responses; (c) institution decisions; (d) patent owner responses; (e) reply briefs; (f) motions; (g) oral hearing transcripts; (h) final written decisions; (i) any settlement agreements or stipulations filed in connection with such proceedings; and (j) any related appellate proceedings before the U.S. Court of Appeals for the Federal Circuit.
F. Damages-Related Documents
REQUEST NO. 55:
All Documents constituting, reflecting, or relating to Apex's revenue, cost of goods sold, gross profit, gross margin, net profit, and net margin for products that compete with, are comparable to, or are asserted to practice the inventions claimed in the Asserted Patents, for each fiscal year from 2019 through the present, including but not limited to internal financial reports, management reports, segment reports, product-line reports, profit-and-loss statements, variance analyses, budget-to-actual reports, and presentations to Apex's board of directors, executive committee, or senior management. Without limitation, this Request covers all products in Apex's trocar systems and surgical access devices product lines, including any products marketed under the TrocarVault™, SealLock™, and ApexAccess™ brand names, as well as any other branded or unbranded trocar products sold by Apex.
REQUEST NO. 56:
All Documents provided to, relied upon by, considered by, or reviewed by Hugh Danaher, CFA, of Keystone Valuation Advisors LLC, in connection with his preparation of the damages analysis or damages report in this matter, to the extent not previously produced in Apex's initial production, including but not limited to: (a) financial data, including revenue data, cost data, and profitability data provided by Apex or its counsel; (b) market reports, industry reports, and market research data; (c) comparable license analyses, including any analyses of royalty rates in comparable license agreements; (d) communications between Mr. Danaher and Apex or its counsel at Hargrove, Tate & Bennington LLP, to the extent not protected by work product or other privilege; (e) draft reports, draft analyses, or preliminary calculations prepared by Mr. Danaher or his firm; and (f) any workpapers, spreadsheets, or databases created or maintained by Mr. Danaher or his firm in connection with this engagement.
REQUEST NO. 57:
All Documents constituting, reflecting, or relating to any royalty or other payments received by Apex under any license agreement for any patent in the Apex Trocar Patent Family, including but not limited to royalty reports submitted by licensees, payment records, wire transfer confirmations, invoices, accounts receivable records, royalty audit reports, and any correspondence between Apex and its licensees regarding the calculation, payment, or dispute of royalty amounts.
REQUEST NO. 58:
All Documents constituting, reflecting, or relating to any valuation, appraisal, or economic analysis of the Asserted Patents or the Apex Trocar Patent Family prepared by or for Apex at any time, including but not limited to: (a) valuations or appraisals prepared by Apex's auditors, Creston Perry LLP, for purposes of financial reporting (including ASC 805 or ASC 350 analyses); (b) valuations or analyses prepared by any financial advisors, investment bankers, or economic consultants in connection with asset valuation, portfolio management, or strategic planning; (c) valuations or analyses prepared in connection with any acquisition, merger, divestiture, or other corporate transaction involving Apex or its patent portfolio; and (d) any internal analyses prepared by Apex's IP department, finance department, or business development team regarding the monetary value, revenue-generating potential, or strategic significance of the Asserted Patents or the Apex Trocar Patent Family.
G. Communications Regarding Solstice and the Accused Products
REQUEST NO. 59:
All internal Apex Communications (including but not limited to emails, memoranda, instant messages transmitted via Meridian Solutions, Northgate Data Systems, or similar platforms, and presentations) that reference, discuss, or relate to Solstice Biomedical Devices Ltd., Solstice Biomedical, Inc., or any of the Accused Products (PrecisionEdge™ PE-5000 Series, PE-12000 Series, or PE-15000 Series), to the extent such Communications were not already produced in Apex's initial production (APEX-000001 through APEX-031450). This Request is intended to capture Communications that may have been excluded from the initial production due to the search terms, date ranges, or custodians used in Apex's initial collection and review, and is made in light of Defendant's identification of at least seven (7) produced Documents that reference additional Communications with or about Solstice that were not themselves produced.
REQUEST NO. 60:
All Communications between Apex and any third party — including but not limited to customers, distributors, group purchasing organizations, hospital systems, ambulatory surgical centers, surgeons, healthcare providers, and medical device consultants — that reference, discuss, compare, evaluate, or otherwise relate to the Accused Products (PrecisionEdge™ PE-5000 Series, PE-12000 Series, or PE-15000 Series) in relation to Apex's products or any products of third parties in the field of laparoscopic surgical access devices.
H. Regulatory Filings and Product Approvals
REQUEST NO. 61:
All Documents constituting, reflecting, or relating to any 510(k) premarket notification submissions, premarket approval ("PMA") applications, investigational device exemption ("IDE") applications, de novo classification requests, or other regulatory filings submitted by Apex to the U.S. Food and Drug Administration ("FDA") relating to Apex's trocar systems and surgical access devices that are alleged or claimed to practice the inventions claimed in the Asserted Patents, including but not limited to: (a) 510(k) summary documents or statements; (b) technical summaries, including descriptions of the device, intended use, and technological characteristics; (c) predicate device analyses and substantial equivalence determinations; (d) performance data submitted to the FDA; (e) FDA clearance letters, approval letters, and any conditions of approval; and (f) any post-market surveillance reports, medical device reports ("MDRs"), or recall notifications relating to such products.
I. Corporate Transactions and Patent Assignment
REQUEST NO. 62:
All Documents constituting, reflecting, or relating to any assignment, transfer, encumbrance, security interest, pledge, mortgage, lien, or other disposition of any rights (including any partial, exclusive, or non-exclusive rights) in any patent or patent application in the Apex Trocar Patent Family, including but not limited to: (a) assignment agreements between inventors and Apex or any predecessor entity; (b) assignments recorded with the U.S. Patent and Trademark Office; (c) chain-of-title documents; (d) security agreements or intellectual property security agreements pursuant to which any patent in the Apex Trocar Patent Family was pledged as collateral; (e) any documents reflecting that any entity or person other than Apex holds, has held, or claims to hold any ownership interest, co-ownership interest, or exclusive license in any of the Asserted Patents; and (f) any documents relating to due diligence investigations of the ownership or chain of title of the Asserted Patents conducted by or on behalf of Apex, its lenders, or potential acquirers.
IV. RESERVATION OF RIGHTS
Solstice reserves the right to serve additional requests for production of documents and other written discovery as permitted by the Federal Rules of Civil Procedure, the Court's Scheduling Order dated July 2, 2024 (D.I. 22), and the Joint discovery Plan filed July 15, 2024 (D.I. 28). Nothing in these Requests shall be construed as a waiver of Solstice's right to propound additional or supplemental discovery requests, nor as an acknowledgment that these Requests encompass all categories of documents relevant to the claims and defenses in this action.
Solstice further reserves the right to supplement, amend, or modify these Requests based on its ongoing review of Apex's document productions, deposition testimony, and other discovery obtained in this matter, including but not limited to documents and information produced by third parties in response to subpoenas issued pursuant to Federal Rule of Civil Procedure 45.
\ \ \*
Respectfully submitted,
CALDERWOOD & HARKNESS LLP
By: ________
Marcus J. Delgado (Del. Bar No. 5847) mdelgado@calderwoodharkness.com
Christy A. Bauer (Del. Bar No. 6312) cbauer@calderwoodharkness.com
Peter D. Vassiliev (Del. Bar No. 6789) pvassiliev@calderwoodharkness.com
CALDERWOOD & HARKNESS LLP 1201 Market Street, Suite 2500 Wilmington, Delaware 19801 Telephone: (302) 555-4100 Facsimile: (302) 555-4101
Attorneys for Defendant Solstice Biomedical, Inc.
Dated: October 14, 2024
CERTIFICATE OF SERVICE
I, Christy A. Bauer, hereby certify that on October 14, 2024, a true and correct copy of Defendant Solstice Biomedical, Inc.'s Second Set of Requests for Production of Documents to Plaintiff Apex Surgical Innovations, Inc. (Nos. 39–62) was served upon the following counsel of record via the Court's CM/ECF electronic filing system, which will send a Notice of Electronic Filing to all registered participants, and by email to:
Victoria R. Stanton, Esq. vstanton@htblaw.com
Derek M. Loomis, Esq. dloomis@htblaw.com
HARGROVE, TATE & BENNINGTON LLP 900 North King Street, Suite 1200 Wilmington, Delaware 19801 Telephone: (302) 555-7800 Facsimile: (302) 555-7801
Counsel for Plaintiff Apex Surgical Innovations, Inc.
________________________________________
Christy A. Bauer (Del. Bar No. 6312) CALDERWOOD & HARKNESS LLP
APEX SURGICAL INNOVATIONS, INC.,
Plaintiff, | Civil Action No. 1:24-cv-00587-RGA
v. | Chief Judge Richard G. Andrews
SOLSTICE BIOMEDICAL, INC.,
Defendant.