Contract analysis

I. INTRODUCTORY STATEMENT Defendant Solstice Biomedical, Inc. ("Solstice" or "Defendant"), by and through its undersigned counsel, Calderwood & Harkness LLP, hereby serves its Responses and Objections to Plaintiff Apex Surgical Innovations, Inc.'s ("Apex" or "Plaintiff") First Set of Interrogatories (Nos. 1–18) (the "Interrogatories"), served on Defendant on August 5, 2024, pursuant to Rules 26 and 33 of the Federal

II. PRELIMINARY STATEMENT AND GENERAL OBJECTIONS Solstice makes the following General Objections, which are incorporated by reference into each specific response set forth below as if fully restated therein. The assertion of a specific objection in response to any particular interrogatory does not waive any General Objection as to that interrogatory, and the failure to assert a specific objection in response to any p

III. SPECIFIC INTERROGATORY RESPONSES AND OBJECTIONS Subject to and without waiver of the foregoing General Objections, which are incorporated by reference into each specific response below, Solstice responds to each of Apex's Interrogatories as follows: INTERROGATORY NO. 1 Identify Defendant Solstice Biomedical, Inc., including its state of incorporation, principal place of business, federal employer identification

1. Niamh Cassidy, Vice President, Regulatory & intellectual Property, Solstice Biomedical Devices Ltd. Ms. Cassidy has knowledge of the design history files, regulatory submissions (including FDA 510(k) clearances), and intellectual property clearance processes for the PrecisionEdge™ product line, including the PE-5000, PE-12000, and PE-15000 Series.

2. Engineering personnel involved in the design and development of the PrecisionEdge™ PE-5000, PE-12000, and PE-15000 Series. Specific names and contact information for these individuals will be identified in a supplemental response following the completion of custodian interviews currently in progress. Solstice notes that a litigation hold notice was issued on May 11, 2024, which identified the relevant custodians;

3. Sales and marketing personnel responsible for the United States distribution and commercialization of the PrecisionEdge™ product line. Specific names and contact information for these individuals will be identified in a supplemental response.

4. Brendan Molloy, Chief Financial Officer, Solstice Biomedical Devices Ltd. Mr. Molloy has knowledge of financial data pertaining to the accused products, including sales figures, revenues, costs of goods sold, and profit margins.

5. Eamon Rourke, General Counsel, Solstice Biomedical Devices Ltd. Mr. Rourke has knowledge of the intellectual property clearance process and freedom-to-operate analyses conducted with respect to the PrecisionEdge™ product line, subject to and without waiver of the attorney-client privilege and work product protection. Solstice reserves the right to supplement this response as its investigation continues and as addi

1. Published patent applications and issued patents identified through searches conducted by Kendrick & Lau LLP and Calderwood & Harkness LLP. Specific references, including patent numbers, publication numbers, titles, inventors, and issue or publication dates, will be set forth in Solstice's Invalidity Contentions, which are currently under preparation. A detailed analysis memorandum cataloging and charting the iden

2. Prior art publications, articles, and technical literature from third-party sources, including conference proceedings, journal articles, and technical manuals relating to laparoscopic trocar assemblies, seal assemblies, blade deployment mechanisms, and insufflation valve configurations. Solstice's technical expert, Dr. Miriam Ostrowski, is reviewing these materials as part of her analysis.

3. Prior art products and commercial systems available before the priority dates of the asserted patents, including products manufactured, sold, or offered for sale by third parties. Documents pertaining to such prior art products have been subpoenaed from Veridian Medical Technologies, Inc. (subpoena duces tecum issued September 12, 2024), and the production of documents responsive to that subpoena is pending.

4. Prior art references cited during prosecution of the '237, '884, and '105 Patents before the United States Patent and Trademark Office, as reflected in the prosecution histories of those patents. Solstice is analyzing the prosecution histories to identify references cited by the Examiner and by the applicant, as well as to evaluate whether all material prior art was disclosed during prosecution. Solstice's formal

1. Niamh Cassidy, Vice President, Regulatory & intellectual Property, Solstice Biomedical Devices Ltd. Ms. Cassidy provided oversight of the design and regulatory process for the PrecisionEdge™ product line, including the design history file review, regulatory submissions, and intellectual property clearance activities.

2. Engineering team members who were directly involved in the mechanical, electrical, and manufacturing engineering design and development of the PE-5000, PE-12000, and PE-15000 Series products. The specific names, titles, roles, and time periods of participation of these individuals are being compiled through custodian interviews that are currently in progress and will be provided in a supplemental response to this

1. Dr. Miriam Ostrowski, Professor of Biomedical Engineering, Halford University, 3401 Walnut Street, Philadelphia, Pennsylvania 19104. Dr. Ostrowski was retained by Solstice pursuant to a retention agreement dated August 20, 2024. Dr. Ostrowski is expected to offer expert testimony on the following subject matters: claim construction of the disputed terms of the asserted claims; invalidity of the asserted claims of

2. Dr. Elena Marchetti, Managing Director, Pinnacle Economics Group LLC, 590 Madison Avenue, 22nd Floor, New York, New York 10022. As of the date of this response, September 16, 2024, Solstice has identified Dr. Marchetti as a prospective damages expert and has engaged in preliminary discussions regarding her retention; however, a formal retention agreement has not yet been executed (anticipated retention agreement d