CALDERWOOD & HARKNESS LLP

1201 Market Street, Suite 2500 Wilmington, DE 19801

Main Office: 299 Park Avenue, 35th Floor New York, NY 10171

Marcus Delgado, Partner Tel: (302) 884-7100

Fax: (302) 884-7101

mdelgado@calderwoodharkness.com

June 17, 2025

VIA CM/ECF ELECTRONIC FILING

The Honorable Chief Judge Richard G. Andrews United States District Court for the District of Delaware J. Caleb Boggs Federal Building 844 North King Street Wilmington, DE 19801

Re: Apex Surgical Innovations, Inc. v. Solstice Biomedical, Inc., Case No. 1:24-cv-00587-RGA — Notice of Settlement and Request to Vacate Trial Date

Dear Chief Judge Andrews:

I am a partner at Calderwood & Harkness LLP and serve as lead counsel of record for Defendant Solstice Biomedical, Inc. ("Solstice"), a Delaware corporation with principal offices at 3800 Concord Pike, Suite 410, Wilmington, Delaware 19803. Solstice is the wholly owned U.S. operating subsidiary of Solstice Biomedical Devices Ltd., an Irish private limited company organized under the laws of the Republic of Ireland. I write on behalf of Solstice to respectfully notify the Court that the parties in the above-captioned action have reached a comprehensive settlement of all claims, counterclaims, and defenses asserted in this litigation. Accordingly, the parties jointly request that the Court vacate all remaining pretrial deadlines and the trial date currently scheduled for September 30, 2025, as more fully set forth below.

I. Procedural Background

A brief recitation of the procedural history is provided for the convenience of the Court. On May 9, 2024, Plaintiff Apex Surgical Innovations, Inc. ("Apex") filed its Complaint in this Court, alleging that Solstice's PrecisionEdge™ line of laparoscopic trocar assemblies—specifically the PE-5000 Series, PE-12000 Series, and PE-15000 Series—infringes three Apex utility patents: United States Patent No. 9,814,237 (entitled "Multi-Seal Trocar Assembly with Self-Retracting Blade Mechanism") ("the '237 Patent"), United States Patent No. 10,271,884 (entitled "Trocar Cannula with Integrated Insufflation Valve and Radial Seal") ("the '884 Patent"), and United States Patent No. 10,932,105 (entitled "Ergonomic Trocar Handle with Force-Limiting Insertion Control") ("the '105 Patent"). The Complaint asserted claims of literal infringement and infringement under the doctrine of equivalents with respect to each of the three asserted patents, and sought injunctive relief, compensatory damages, enhanced damages, and attorneys' fees.

On June 14, 2024, Solstice timely filed its Answer, Affirmative Defenses, and Counterclaims. Solstice's Counterclaims sought, among other relief, declaratory judgments of non-infringement and invalidity with respect to each of the asserted patents. The Court entered a Scheduling Order on July 2, 2024, which established deadlines for fact discovery, claim construction briefing, expert discovery, dispositive motions, pretrial submissions, and trial.

The Court held a Markman hearing on November 18, 2024, at which the parties presented argument and evidence regarding the construction of twelve disputed claim terms across the three asserted patents. The Court subsequently issued its Claim Construction Order on December 6, 2024, construing the disputed claim terms and establishing the framework for the remainder of the case.

Following claim construction, the parties completed expert discovery, including the exchange of opening expert reports on damages, technical infringement, and validity, as well as rebuttal expert reports. Depositions of the parties' respective experts were taken in accordance with the Court's Scheduling Order.

On March 17, 2025, the parties participated in a full-day mediation session before the Honorable Margaret Forsythe (Ret.) of Amberstone ADR Services. Although the mediation facilitated productive discussions and narrowed certain issues between the parties, the session did not result in a resolution of the dispute at that time.

On April 1, 2025, Solstice filed a Motion for Summary Judgment of Non-Infringement with respect to the PE-5000 Series of trocar assemblies, supported by extensive expert and documentary evidence. On April 14, 2025, Apex filed a Cross-Motion for Partial Summary Judgment of Infringement with respect to the PE-12000 Series. Both motions were fully briefed, and on May 5, 2025, the Court denied both motions without prejudice. In its Order, the Court directed the parties to participate in a second settlement conference and expressed its strong encouragement that the parties attempt to resolve the matter prior to trial.

Pursuant to the Court's direction, a second settlement conference was held on May 12, 2025, before United States Magistrate Judge Colleen Pratt. The settlement conference was attended by counsel for both parties and by representatives of the parties with full settlement authority. While a settlement was not reached at the conclusion of that conference, the discussions conducted under Magistrate Judge Pratt's guidance proved instrumental in advancing the parties toward a resolution.

Following the second settlement conference, intensive and sustained negotiations between the parties and their respective counsel took place over the period from May 19, 2025, through June 4, 2025. These negotiations involved multiple rounds of proposals, counter-proposals, and exchanges of draft agreements, and ultimately resulted in the parties reaching an agreement in principle on the material terms of a comprehensive settlement.

II. Notice of Settlement

The parties are pleased to inform the Court that they have reached a full and final settlement of all matters in controversy in this action. On June 10, 2025, the parties executed a binding Term Sheet memorializing the principal terms of a license-and-dismissal settlement, including the material commercial terms, the scope of mutual releases, and the form and timing of the contemplated dismissal. Thereafter, the parties and their counsel negotiated and finalized the definitive documentation implementing the settlement.

On June 16, 2025, the parties executed a Definitive Settlement Agreement and Mutual Release (the "Settlement Agreement"), together with all ancillary agreements and exhibits thereto, fully and finally resolving all claims, counterclaims, affirmative defenses, and all other matters asserted or that could have been asserted in this action, Case No. 1:24-cv-00587-RGA.

The Settlement Agreement provides, among other things, for a comprehensive mutual release of all claims and counterclaims asserted in this action, including all claims for patent infringement, declaratory relief, damages, injunctive relief, attorneys' fees, and costs. The settlement further provides for the parties' filing of a Stipulation of Dismissal with Prejudice of all claims and counterclaims, with each party bearing its own costs, expenses, and attorneys' fees. The specific commercial terms of the settlement are confidential as between the parties and are not material to the relief requested herein.

Plaintiff Apex is represented in this matter by Victoria Stanton, Esq. and Derek Loomis, Esq. of Hargrove, Tate & Bennington LLP, 900 North King Street, Suite 1200, Wilmington, Delaware 19801. Counsel for Apex has been consulted regarding this letter and its contents, and has authorized undersigned counsel to represent to the Court that Apex concurs in this notification of settlement and in the requests set forth herein. This letter is submitted on behalf of both parties for the Court's consideration.

III. Request to Vacate the Trial Date and All Remaining Pretrial Deadlines

In light of the foregoing settlement, the parties respectfully and jointly request that the Court enter an Order vacating the jury trial date of September 30, 2025, as well as all remaining pretrial deadlines and obligations set forth in the Scheduling Order entered on July 2, 2024, including but not limited to all deadlines for pretrial memoranda, motions in limine, proposed jury instructions, exhibit and witness lists, and the final pretrial conference. The parties submit that good cause exists for this request, as the comprehensive settlement of all claims and counterclaims renders further pretrial proceedings unnecessary and would result in an unwarranted expenditure of the Court's and the parties' resources.

The parties anticipate filing a Stipulation of Dismissal with Prejudice pursuant to Federal Rule of Civil Procedure 41(a)(1)(A)(ii) on or about July 1, 2025, consistent with the terms and timetable established in the Settlement Agreement. The brief interval between the date of this letter and the anticipated filing of the Stipulation is necessary to permit the completion of certain ministerial and administrative steps contemplated by the Settlement Agreement, including the execution and delivery of ancillary instruments.

In addition, the parties respectfully request that the Court retain jurisdiction over this action solely for the limited purpose of enforcing the terms of the Stipulation of Dismissal, if necessary, until such time as the Stipulation of Dismissal with Prejudice is filed and an Order of Dismissal has been entered by the Court. Upon entry of the Order of Dismissal, no further action by the Court should be required.

IV. Conclusion

Counsel for both parties wish to express their sincere gratitude to the Court for its careful and efficient management of this case throughout the course of the litigation. The Court's thoughtful Claim Construction Order and its guidance at each stage of the proceedings contributed meaningfully to the parties' ability to evaluate their respective positions and ultimately reach a resolution. The parties also wish to express their particular appreciation to Magistrate Judge Pratt for her tireless efforts and skillful facilitation during the May 12, 2025 settlement conference, which proved invaluable in advancing the parties toward the settlement that has now been achieved.

The parties will promptly file the Stipulation of Dismissal with Prejudice and the proposed Order of Dismissal with the Court as soon as practicable, and in no event later than July 1, 2025, absent unforeseen circumstances. Should the Court require any additional information, supplemental submissions, or a hearing in connection with the requests set forth herein, undersigned counsel respectfully asks the Court to contact him at the telephone number or email address set forth above, and he will respond promptly.

Thank you for Your Honor's time and attention to this matter.

Respectfully submitted,

CALDERWOOD & HARKNESS LLP

By: ________

Marcus Delgado, Partner Calderwood & Harkness LLP 1201 Market Street, Suite 2500 Wilmington, DE 19801 Tel: (302) 884-7100

Email: mdelgado@calderwoodharkness.com

Counsel for Defendant Solstice Biomedical, Inc.

cc: Victoria Stanton, Esq., Hargrove, Tate & Bennington LLP, 900 North King Street, Suite 1200, Wilmington, DE 19801

Eamon Rourke, General Counsel, Solstice Biomedical Devices Ltd.

CALDERWOOD & HARKNESS LLP
1201 Market Street, Suite 2500 Wilmington, DE 19801
Main Office: 299 Park Avenue, 35th Floor New York, NY 10171
Marcus Delgado, Partner Tel: (302) 884-7100
Fax: (302) 884-7101
mdelgado@calderwoodharkness.com
June 17, 2025
VIA CM/ECF ELECTRONIC FILING
The Honorable Chief Judge Richard G. Andrews United States District Court for the District of Delaware J. Caleb Boggs Federal Building 844 North King Street Wilmington, DE 19801
Re: Apex Surgical Innovations, Inc. v. Solstice Biomedical, Inc., Case No. 1:24-cv-00587-RGA — Notice of Settlement and Request to Vacate Trial Date
Dear Chief Judge Andrews:
I am a partner at Calderwood & Harkness LLP and serve as lead counsel of record for Defendant Solstice Biomedical, Inc. ("Solstice"), a Delaware corporation with principal offices at 3800 Concord Pike, Suite 410, Wilmington, Delaware 19803. Solstice is the wholly owned U.S. operating subsidiary of Solstice Biomedical Devices Ltd., an Irish private limited company organized under the laws of the Republic of Ireland. I write on behalf of Solstice to respectfully notify the Court that the parties in the above-captioned action have reached a comprehensive settlement of all claims, counterclaims, and defenses asserted in this litigation. Accordingly, the parties jointly request that the Court vacate all remaining pretrial deadlines and the trial date currently scheduled for September 30, 2025, as more fully set forth below.
I. Procedural Background
A brief recitation of the procedural history is provided for the convenience of the Court. On May 9, 2024, Plaintiff Apex Surgical Innovations, Inc. ("Apex") filed its Complaint in this Court, alleging that Solstice's PrecisionEdge™ line of laparoscopic trocar assemblies—specifically the PE-5000 Series, PE-12000 Series, and PE-15000 Series—infringes three Apex utility patents: United States Patent No. 9,814,237 (entitled "Multi-Seal Trocar Assembly with Self-Retracting Blade Mechanism") ("the '237 Patent"), United States Patent No. 10,271,884 (entitled "Trocar Cannula with Integrated Insufflation Valve and Radial Seal") ("the '884 Patent"), and United States Patent No. 10,932,105 (entitled "Ergonomic Trocar Handle with Force-Limiting Insertion Control") ("the '105 Patent"). The Complaint asserted claims of literal infringement and infringement under the doctrine of equivalents with respect to each of the three asserted patents, and sought injunctive relief, compensatory damages, enhanced damages, and attorneys' fees.
On June 14, 2024, Solstice timely filed its Answer, Affirmative Defenses, and Counterclaims. Solstice's Counterclaims sought, among other relief, declaratory judgments of non-infringement and invalidity with respect to each of the asserted patents. The Court entered a Scheduling Order on July 2, 2024, which established deadlines for fact discovery, claim construction briefing, expert discovery, dispositive motions, pretrial submissions, and trial.
The Court held a Markman hearing on November 18, 2024, at which the parties presented argument and evidence regarding the construction of twelve disputed claim terms across the three asserted patents. The Court subsequently issued its Claim Construction Order on December 6, 2024, construing the disputed claim terms and establishing the framework for the remainder of the case.
Following claim construction, the parties completed expert discovery, including the exchange of opening expert reports on damages, technical infringement, and validity, as well as rebuttal expert reports. Depositions of the parties' respective experts were taken in accordance with the Court's Scheduling Order.
On March 17, 2025, the parties participated in a full-day mediation session before the Honorable Margaret Forsythe (Ret.) of Amberstone ADR Services. Although the mediation facilitated productive discussions and narrowed certain issues between the parties, the session did not result in a resolution of the dispute at that time.
On April 1, 2025, Solstice filed a Motion for Summary Judgment of Non-Infringement with respect to the PE-5000 Series of trocar assemblies, supported by extensive expert and documentary evidence. On April 14, 2025, Apex filed a Cross-Motion for Partial Summary Judgment of Infringement with respect to the PE-12000 Series. Both motions were fully briefed, and on May 5, 2025, the Court denied both motions without prejudice. In its Order, the Court directed the parties to participate in a second settlement conference and expressed its strong encouragement that the parties attempt to resolve the matter prior to trial.
Pursuant to the Court's direction, a second settlement conference was held on May 12, 2025, before United States Magistrate Judge Colleen Pratt. The settlement conference was attended by counsel for both parties and by representatives of the parties with full settlement authority. While a settlement was not reached at the conclusion of that conference, the discussions conducted under Magistrate Judge Pratt's guidance proved instrumental in advancing the parties toward a resolution.
Following the second settlement conference, intensive and sustained negotiations between the parties and their respective counsel took place over the period from May 19, 2025, through June 4, 2025. These negotiations involved multiple rounds of proposals, counter-proposals, and exchanges of draft agreements, and ultimately resulted in the parties reaching an agreement in principle on the material terms of a comprehensive settlement.
II. Notice of Settlement
The parties are pleased to inform the Court that they have reached a full and final settlement of all matters in controversy in this action. On June 10, 2025, the parties executed a binding Term Sheet memorializing the principal terms of a license-and-dismissal settlement, including the material commercial terms, the scope of mutual releases, and the form and timing of the contemplated dismissal. Thereafter, the parties and their counsel negotiated and finalized the definitive documentation implementing the settlement.
On June 16, 2025, the parties executed a Definitive Settlement Agreement and Mutual Release (the "Settlement Agreement"), together with all ancillary agreements and exhibits thereto, fully and finally resolving all claims, counterclaims, affirmative defenses, and all other matters asserted or that could have been asserted in this action, Case No. 1:24-cv-00587-RGA.
The Settlement Agreement provides, among other things, for a comprehensive mutual release of all claims and counterclaims asserted in this action, including all claims for patent infringement, declaratory relief, damages, injunctive relief, attorneys' fees, and costs. The settlement further provides for the parties' filing of a Stipulation of Dismissal with Prejudice of all claims and counterclaims, with each party bearing its own costs, expenses, and attorneys' fees. The specific commercial terms of the settlement are confidential as between the parties and are not material to the relief requested herein.
Plaintiff Apex is represented in this matter by Victoria Stanton, Esq. and Derek Loomis, Esq. of Hargrove, Tate & Bennington LLP, 900 North King Street, Suite 1200, Wilmington, Delaware 19801. Counsel for Apex has been consulted regarding this letter and its contents, and has authorized undersigned counsel to represent to the Court that Apex concurs in this notification of settlement and in the requests set forth herein. This letter is submitted on behalf of both parties for the Court's consideration.
III. Request to Vacate the Trial Date and All Remaining Pretrial Deadlines
In light of the foregoing settlement, the parties respectfully and jointly request that the Court enter an Order vacating the jury trial date of September 30, 2025, as well as all remaining pretrial deadlines and obligations set forth in the Scheduling Order entered on July 2, 2024, including but not limited to all deadlines for pretrial memoranda, motions in limine, proposed jury instructions, exhibit and witness lists, and the final pretrial conference. The parties submit that good cause exists for this request, as the comprehensive settlement of all claims and counterclaims renders further pretrial proceedings unnecessary and would result in an unwarranted expenditure of the Court's and the parties' resources.
The parties anticipate filing a Stipulation of Dismissal with Prejudice pursuant to Federal Rule of Civil Procedure 41(a)(1)(A)(ii) on or about July 1, 2025, consistent with the terms and timetable established in the Settlement Agreement. The brief interval between the date of this letter and the anticipated filing of the Stipulation is necessary to permit the completion of certain ministerial and administrative steps contemplated by the Settlement Agreement, including the execution and delivery of ancillary instruments.
In addition, the parties respectfully request that the Court retain jurisdiction over this action solely for the limited purpose of enforcing the terms of the Stipulation of Dismissal, if necessary, until such time as the Stipulation of Dismissal with Prejudice is filed and an Order of Dismissal has been entered by the Court. Upon entry of the Order of Dismissal, no further action by the Court should be required.
IV. Conclusion
Counsel for both parties wish to express their sincere gratitude to the Court for its careful and efficient management of this case throughout the course of the litigation. The Court's thoughtful Claim Construction Order and its guidance at each stage of the proceedings contributed meaningfully to the parties' ability to evaluate their respective positions and ultimately reach a resolution. The parties also wish to express their particular appreciation to Magistrate Judge Pratt for her tireless efforts and skillful facilitation during the May 12, 2025 settlement conference, which proved invaluable in advancing the parties toward the settlement that has now been achieved.
The parties will promptly file the Stipulation of Dismissal with Prejudice and the proposed Order of Dismissal with the Court as soon as practicable, and in no event later than July 1, 2025, absent unforeseen circumstances. Should the Court require any additional information, supplemental submissions, or a hearing in connection with the requests set forth herein, undersigned counsel respectfully asks the Court to contact him at the telephone number or email address set forth above, and he will respond promptly.
Thank you for Your Honor's time and attention to this matter.
Respectfully submitted,
CALDERWOOD & HARKNESS LLP
By: ________
Marcus Delgado, Partner Calderwood & Harkness LLP 1201 Market Street, Suite 2500 Wilmington, DE 19801 Tel: (302) 884-7100
Email: mdelgado@calderwoodharkness.com
Counsel for Defendant Solstice Biomedical, Inc.
cc: Victoria Stanton, Esq., Hargrove, Tate & Bennington LLP, 900 North King Street, Suite 1200, Wilmington, DE 19801
Eamon Rourke, General Counsel, Solstice Biomedical Devices Ltd.

CALDERWOOD & HARKNESS LLP

VIA CM/ECF ELECTRONIC FILING

CALDERWOOD & HARKNESS LLP

Record

Parties

Dates

Amounts