Contract analysis

I. INTRODUCTION AND PRELIMINARY STATEMENT Pursuant to Federal Rule of Civil Procedure 26(f), Local Rule 16.1, and the Scheduling Order entered by this Court following the Initial Scheduling Conference held on July 2, 2024, Plaintiff Apex Surgical Innovations, Inc. ("Apex" or "Plaintiff") and Defendant Solstice Biomedical, Inc. ("Solstice" or "Defendant") (collectively, the "Parties"), by and through their respective

II. IDENTIFICATION OF THE PARTIES AND COUNSEL A. Plaintiff. Plaintiff 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. Apex is engaged in the design, development, manufacture, and sale of minimally invasive surgical instruments and access devi

III. NATURE AND BASIS OF CLAIMS AND DEFENSES A. Plaintiff's Claims Plaintiff asserts claims for patent infringement under 35 U.S.C. § 271 based on the manufacture, use, sale, offer for sale, and importation of the Accused Products. The Asserted Patents, the claims at issue, and the accused products are identified as follows:

1. U.S. Patent No. 9,814,237 (the "'237 Patent") • Title: "Locking Seal Assembly for Minimally Invasive Surgical Access Device" • Asserted Claims: Claims 1, 3, 7, and 12 • Issue Date: November 14, 2017 • Expiration Date: June 22, 2035 • Named Inventor: Dr. Raymond Szabo • Assignee: Apex Surgical Innovations, Inc. • Accused Products: PrecisionEdge™ PE-5000 Series (5 mm trocar assembly) and PrecisionEdge™ PE-12000 Seri

2. U.S. Patent No. 10,271,884 (the "'884 Patent") • Title: "Retractable Blade Deployment Mechanism for Trocar Systems" • Asserted Claims: Claims 1, 2, 5, 9, and 14 • Issue Date: April 30, 2019 • Expiration Date: September 15, 2036 • Named Inventor: Dr. Raymond Szabo • Assignee: Apex Surgical Innovations, Inc. • Accused Products: PrecisionEdge™ PE-5000 Series (5 mm trocar assembly), PrecisionEdge™ PE-12000 Series (12

3. U.S. Patent No. 10,932,105 (the "'105 Patent") • Title: "Integrated Insufflation Valve and Seal for Laparoscopic Trocar" • Asserted Claims: Claims 1, 4, and 8 • Issue Date: March 2, 2021 • Expiration Date: January 10, 2038 • Named Inventor: Dr. Raymond Szabo • Assignee: Apex Surgical Innovations, Inc. • Accused Products: PrecisionEdge™ PE-12000 Series (12 mm trocar assembly) and PrecisionEdge™ PE-15000 Series (15

1. Non-Infringement. Defendant denies that any of the Accused Products infringes any asserted claim of the '237 Patent, the '884 Patent, or the '105 Patent, either literally or under the doctrine of equivalents. Defendant contends that the PrecisionEdge™ products were independently developed and employ materially different structures and mechanisms from those claimed in the Asserted Patents.

2. Invalidity. Defendant contends that each asserted claim of the Asserted Patents is invalid under 35 U.S.C. § 102 (anticipation) and/or 35 U.S.C. § 103 (obviousness) in view of prior art references, including prior art patents, published patent applications, printed publications, and prior public uses or sales. Defendant's invalidity contentions will identify the specific prior art references and the bases for anti

3. Inequitable Conduct. Defendant asserts that the Asserted Patents are unenforceable due to inequitable conduct during prosecution before the USPTO, specifically alleging that material prior art references were withheld from the Patent Examiner with the intent to deceive.

4. Counterclaims. Defendant has asserted counterclaims seeking declaratory judgments of non-infringement and invalidity as to each of the Asserted Patents pursuant to the Declaratory Judgment Act, 28 U.S.C. §§ 2201–2202.

IV. PROPOSED DISCOVERY SCHEDULE The Parties propose the following discovery schedule, subject to modification by the Court. Unless otherwise specified, all dates refer to calendar days, and any deadline falling on a weekend or federal holiday shall be extended to the next business day. A. Fact discovery With respect to interrogatories, Plaintiff anticipates serving an initial set of approximately eighteen (18) interr

V. WRITTEN DISCOVERY — SCOPE AND LIMITATIONS A. Interrogatories. Interrogatories shall be governed by Federal Rule of Civil Procedure 33. Each Party shall be limited to twenty-five (25) interrogatories per set, including all discrete subparts, consistent with the default limit under Rule 33(a)(1). The Parties reserve the right to seek leave of Court or agreement of the opposing Party for additional interrogatories be

VI. ELECTRONICALLY STORED INFORMATION (ESI) PROTOCOL A. General Principles The Parties agree to cooperate in good faith regarding the identification, preservation, collection, review, and production of electronically stored information ("ESI") in this action. The proportionality principles of Federal Rule of Civil Procedure 26(b)(1) shall govern the scope of ESI discovery, taking into account the importance of the is

VII. CONFIDENTIALITY / PROTECTIVE ORDER A. Framework. The Parties agree to submit a stipulated Protective Order to the Court for entry pursuant to Federal Rule of Civil Procedure 26(c). The Protective Order will establish the following two-tiered confidentiality framework: Tier 1 — CONFIDENTIAL: Information that the designating Party in good faith believes constitutes confidential business information, the disclosure

VIII. THIRD-PARTY DISCOVERY Defendant anticipates issuing one or more third-party subpoenas duces tecum to entities possessing documents or information relevant to Defendant's invalidity defenses. Specifically, Defendant anticipates serving a subpoena duces tecum on Veridian Medical Technologies, Inc. seeking prior art documents, including patent applications, published articles, technical presentations, and product

IX. PATENT-SPECIFIC DISCOVERY ISSUES A. Infringement Contentions Plaintiff shall serve detailed infringement contentions identifying, on a claim-by-claim and element-by-element basis, how each Accused Product (PrecisionEdge™ PE-5000 Series, PE-12000 Series, and PE-15000 Series) is alleged to meet each limitation of the asserted claims of the '237 Patent, the '884 Patent, and the '105 Patent. Plaintiff's infringement

X. EXPERT DISCOVERY PROCEDURES A. Expert Identification and Reports Each Party shall identify its testifying experts no later than January 6, 2025, which is seven (7) days before the opening of expert discovery on January 13, 2025. Expert identifications shall include the name, qualifications, and subject matter of each expert's anticipated testimony. Opening expert reports shall be served in accordance with the stag

XI. DISCOVERY DISPUTE RESOLUTION The Parties agree to the following procedures for the resolution of discovery disputes:

1. Meet and Confer Requirement. Before filing any discovery motion with the Court, the aggrieved Party shall meet and confer in good faith with the opposing Party, either in person or by telephone, to attempt to resolve the dispute without Court intervention. The meet-and-confer shall address the specific discovery at issue, the basis for any objection or refusal to produce, and potential compromises or accommodation

2. Letter Brief Procedure. If the meet-and-confer is unsuccessful, the aggrieved Party shall send a letter brief to the Court, not to exceed three (3) single-spaced pages, identifying the discovery dispute, summarizing the Parties' respective positions, and requesting relief. The letter brief shall be simultaneously served on opposing counsel. The opposing Party may submit a responsive letter brief, also not to excee

3. Court Determination. Upon receipt of the letter briefs, the Court will determine whether the matter can be resolved on the papers, or whether further briefing, a telephonic hearing, or in-person argument is warranted. The Parties will comply with any supplemental briefing schedule or hearing date set by the Court.

4. Timeliness. Consistent with the Scheduling Order entered on July 2, 2024, all discovery disputes should be raised promptly and not held in reserve. A Party's failure to timely raise a discovery dispute may be considered by the Court in determining the appropriate resolution.

XII. SUPPLEMENTATION OBLIGATIONS The Parties shall supplement their discovery responses in accordance with Federal Rule of Civil Procedure 26(e). Supplementation shall be made in a timely manner as additional or corrective information becomes available. In no event shall supplementation be made later than thirty (30) days before the close of fact discovery (i.e., on or before November 20, 2024 for fact discovery resp

XIII. PRESERVATION OBLIGATIONS Both Parties acknowledge and represent that they have issued litigation hold notices to custodians with potentially relevant information and have taken steps to ensure the preservation of documents and ESI relevant to this action. Defendant represents that its litigation hold notice was issued on May 11, 2024, the date on which Defendant received service of the Complaint. Defendant's li

XIV. MEDIATION / SETTLEMENT DISCUSSIONS The Parties acknowledge the Court's standing order regarding mediation and alternative dispute resolution, as well as the Court's encouragement that the Parties explore settlement at appropriate junctures in this litigation. The Parties agree to participate in mediation or settlement discussions as ordered by the Court, and further agree to engage in such discussions in good fa

XV. TRIAL DATE Trial is currently scheduled to commence on September 30, 2025, as set forth in the Scheduling Order entered by the Court on July 2, 2024. The Parties will comply with all pre-trial deadlines as set by the Court in connection with the pre-trial conference and any pre-trial order, including deadlines for the submission of proposed jury instructions, motions in limine, witness and exhibit lists, trial br

XVI. AGREEMENTS REGARDING DISCOVERY The Parties have agreed to the following cooperative discovery measures to promote the efficient and orderly conduct of discovery in this action:

1. Rolling Productions. The Parties will make document productions on a rolling basis on a reasonable timetable, rather than waiting to produce all documents in a single production at the applicable deadline. The Parties agree to prioritize the production of documents most critical to the pending claims and defenses.

2. Common ESI Production Format. The Parties have agreed to a common ESI production format, as set forth in Section VI.D of this Joint discovery Plan, including single-page TIFF images with extracted text and standard metadata fields, native production for spreadsheets and databases, and agreed-upon Bates numbering prefixes.

3. Fed. R. Evid. 502(d) Clawback Order. The Parties have agreed to seek entry of a Rule 502(d) order to protect against inadvertent waiver of privilege, with clawback procedures as described in Section VI.E.

4. Stipulated Protective Order. The Parties have agreed to a two-tiered confidentiality framework (CONFIDENTIAL and HIGHLY CONFIDENTIAL — ATTORNEYS' EYES ONLY) and will submit a stipulated Protective Order to the Court for entry, as described in Section VII.

5. Good-Faith Meet and Confer. The Parties have agreed to meet and confer in good faith before filing any discovery motion, and to utilize the letter brief procedure described in Section XI for any disputes that cannot be resolved through the meet-and-confer process.

6. Technology-Assisted Review (TAR). The Parties have agreed that TAR (including TAR 2.0 continuous active learning) is an acceptable methodology for document review, subject to the disclosure and validation provisions described in Section VI.C.

XVII. MATTERS ON WHICH THE PARTIES DISAGREE Notwithstanding the significant areas of agreement described above, the Parties currently disagree on the following issues:

1. Scope of Financial discovery. Plaintiff seeks the production of worldwide sales and financial data for Defendant's PrecisionEdge™ products, including sales made by Defendant's parent company, Solstice Biomedical Devices Ltd., and its affiliates and distributors outside the United States. Plaintiff contends that worldwide financial data is relevant to damages analysis, including the determination of a reasonable ro

2. Access to Defendant's Source Code and CAD Files. Plaintiff seeks access to source code (including firmware and embedded software) and CAD design files for the Accused Products for purposes of conducting a detailed technical analysis of the accused structures and their correspondence to the claim limitations of the Asserted Patents. Plaintiff proposes that such access be provided under an ATTORNEYS' EYES ONLY desig

3. Number of Claim Terms for Construction. Plaintiff proposes that up to fifteen (15) claim terms be submitted to the Court for construction at the Markman hearing. Plaintiff contends that the breadth of the Asserted Patents (three patents, twelve asserted claims) and the complexity of the disputed technology warrant a more comprehensive claim construction proceeding. Defendant proposes limiting the number of dispute

1. Extended Fact discovery Period. The Parties agree to a fact discovery period extending through December 20, 2024, which exceeds the default six-month discovery period that would otherwise apply under the Federal Rules. The Parties submit that the extended period is warranted by the complexity of this patent infringement action, including the number of Asserted Patents and asserted claims, the number of Accused Pro

2. Interrogatory Limits. The Parties agree that the twenty-five (25) interrogatory limit under Federal Rule of Civil Procedure 33(a)(1) shall apply per set of interrogatories, rather than cumulatively across all sets. Subsequent sets of interrogatories beyond the initial set shall require either leave of Court or the written consent of the opposing Party. This modification is intended to provide flexibility for follo