1037-00004 · Solstice Biomedical Devices Ltd · Settlement Documentation

exhibit-b-covenant-not-to-sue.docx DOCUMENT Litigation

56 / 75 ← → ✕

EXHIBIT B

COVENANT NOT TO SUE

June 16, 2025

Exhibit B to the Settlement Agreement and Mutual Release dated June 16, 2025 (the "Settlement Agreement") by and among Solstice Biomedical Devices Ltd., Solstice Biomedical, Inc., and Apex Surgical Innovations, Inc.

This COVENANT NOT TO SUE (this "Covenant") is made and entered into as of June 16, 2025 (the "Effective Date"), by and among:

Apex Surgical Innovations, Inc., a corporation organized and existing under the laws of the State of Delaware, with its principal office located at 1220 North Market Street, Suite 550, Wilmington, Delaware 19801 (EIN: 51-0483762) (hereinafter referred to as "Covenantor" or "Apex");

and

Solstice Biomedical Devices Ltd., a private limited company organized and existing under the laws of Ireland (Companies Registration Office No. 648217), with its registered office at Unit 14, Clonskeagh Business Park, Clonskeagh Road, Dublin 14, D14 YF28, Ireland (hereinafter referred to as "Solstice Parent");

and

Solstice Biomedical, Inc., a corporation organized and existing under the laws of the State of Delaware (EIN: 84-3291056), with its principal offices at 3800 Concord Pike, Suite 410, Wilmington, Delaware 19803 (hereinafter referred to as "Solstice US").

Solstice Parent and Solstice US are hereinafter collectively referred to as the "Covenantees" or the "Solstice Entities." Apex, Solstice Parent, and Solstice US are hereinafter individually referred to as a "Party" and collectively as the "Parties."

RECITALS

WHEREAS:

A. The Litigation. On May 9, 2024, Apex filed a complaint against Solstice Biomedical, Inc. in the United States District Court for the District of Delaware, Case No. 1:24-cv-00587-RGA, captioned Apex Surgical Innovations, Inc. v. Solstice Biomedical, Inc., before the Honorable Chief Judge Richard G. Andrews (the "Litigation"), alleging infringement of United States Patent Nos. 9,814,237 (the "'237 Patent"), 10,271,884 (the "'884 Patent"), and 10,932,105 (the "'105 Patent") (collectively, the "Asserted Patents"). The Litigation involves claims of direct infringement, contributory infringement, and inducement of infringement arising out of the manufacture, use, sale, offer for sale, and importation of certain laparoscopic surgical access devices marketed by Solstice US under the PrecisionEdge™ product line;

B. The Settlement Agreement. The Parties have entered into a Settlement Agreement and Mutual Release dated June 16, 2025 (the "Settlement Agreement"), pursuant to which the Parties have agreed to fully, finally, and irrevocably resolve all claims, counterclaims, defenses, and disputes between and among them in the Litigation, and to dismiss the Litigation with prejudice in accordance with a Stipulation of Dismissal to be filed with the Court;

C. The Patent License Agreement. In connection with the Settlement Agreement, Apex has granted to Solstice Biomedical, Inc. and Solstice Biomedical Devices Ltd. a non-exclusive license under the Licensed Patents (as defined therein), as set forth in the Patent License Agreement (Non-Exclusive) attached as Exhibit A to the Settlement Agreement (the "Patent License Agreement"), which Patent License Agreement sets forth the terms and conditions of the license, including the scope of the Licensed Field, sublicense rights, and royalty obligations;

D. The Term Sheet. The Parties previously executed a binding Term Sheet dated June 10, 2025 (the "Term Sheet"), setting forth the principal terms upon which the Parties agreed to settle the Litigation, including, among other things, the covenant not to sue contemplated by this Covenant. The Settlement Agreement, the Patent License Agreement, and this Covenant are intended to memorialize and implement the terms set forth in the Term Sheet;

E. Consideration. This Covenant Not to Sue is delivered as part of the consideration for the Settlement Agreement. The consideration for the Settlement Agreement includes, without limitation: (i) a lump-sum payment by the Solstice Entities to Apex in the aggregate amount of Eight Million Seven Hundred Fifty Thousand Dollars ($8,750,000), payable in two tranches — Tranche 1 in the amount of Five Million Two Hundred Fifty Thousand Dollars ($5,250,000), due and payable on or before June 30, 2025, and Tranche 2 in the amount of Three Million Five Hundred Thousand Dollars ($3,500,000), due and payable on or before September 15, 2025; and (ii) a running royalty of three and three-quarters percent (3.75%) of Net Sales of Licensed Products (as such terms are defined in the Patent License Agreement), payable in accordance with the terms and schedule set forth in the Patent License Agreement. The Parties acknowledge that this Covenant constitutes a material inducement for the Solstice Entities to enter into the Settlement Agreement and the Patent License Agreement and to make the payments described herein.

NOW, THEREFORE, in consideration of the foregoing recitals (which are incorporated herein by reference as material terms of this Covenant), the mutual covenants and agreements set forth herein, the consideration set forth in the Settlement Agreement, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:

SECTION 1 — DEFINITIONS

1.1 Defined Terms. Capitalized terms used but not otherwise defined in this Covenant shall have the meanings ascribed to such terms in the Settlement Agreement or the Patent License Agreement (Exhibit A to the Settlement Agreement), as applicable. In the event that a term is defined in both the Settlement Agreement and the Patent License Agreement, and such definitions are inconsistent, the definition set forth in the Settlement Agreement shall control for purposes of this Covenant unless the context requires otherwise.

1.2 "Apex Trocar Patent Family" means the portfolio of patents and patent applications owned or controlled by Apex Surgical Innovations, Inc. relating to trocar and surgical access device technology, consisting of the following:

(a) Fourteen (14) issued United States patents, including but not limited to:

(i) U.S. Patent No. 9,814,237, entitled "Locking Seal Assembly for Minimally Invasive Surgical Access Device," issued November 14, 2017, with an expiration date of June 22, 2035 (the "'237 Patent");

(ii) U.S. Patent No. 10,271,884, entitled "Retractable Blade Deployment Mechanism for Trocar Systems," issued April 30, 2019, with an expiration date of September 15, 2036 (the "'884 Patent");

(iii) U.S. Patent No. 10,932,105, entitled "Integrated Insufflation Valve and Seal for Laparoscopic Trocar," issued March 2, 2021, with an expiration date of January 10, 2038 (the "'105 Patent"); and

(iv) The remaining eleven (11) issued United States patents as listed and identified on Exhibit C to the Settlement Agreement (the "Exhibit C Patent List"), which Exhibit C Patent List is incorporated herein by reference;

(b) Six (6) pending United States continuation applications, as listed and identified on Exhibit C to the Settlement Agreement;

(c) Any and all patents issuing from such pending applications described in subsection (b) above during the Term, including any patents issuing from continuations, continuations-in-part, divisional applications, reissue applications, reexamination proceedings, inter partes review proceedings, or post-grant review proceedings relating to any of the foregoing patents or patent applications, to the extent owned or controlled by Apex during the Term;

(d) Any and all extensions, supplementary protection certificates, or other statutory extensions of term applicable to any of the foregoing patents, to the extent owned or controlled by Apex during the Term; and

(e) Any foreign counterpart patents or patent applications corresponding to any of the foregoing, to the extent owned or controlled by Apex during the Term.

The Parties acknowledge that the named inventor on the Asserted Patents and the principal inventor within the Apex Trocar Patent Family is Dr. Raymond Szabo, Vice President of Engineering at Apex Surgical Innovations, Inc. Nothing herein shall be construed to grant any rights with respect to inventions or patents that are not within the Apex Trocar Patent Family as defined herein.

1.3 "Covenantee Entities" means (a) Solstice Biomedical Devices Ltd.; (b) Solstice Biomedical, Inc.; and (c) any direct or indirect subsidiary, parent, or affiliate of either of the foregoing entities, now existing or hereafter formed, organized, or acquired during the Term, for so long as such entity qualifies as a subsidiary, parent, or affiliate of either Solstice Parent or Solstice US. For purposes of this Section 1.3, the term "affiliate" shall have the meaning ascribed to it in the Patent License Agreement.

1.4 "Covered Products" means any product, device, system, component, or assembly that falls within the Licensed Field, including but not limited to the following product lines currently manufactured, marketed, or sold by or on behalf of any Covenantee Entity:

(a) PrecisionEdge™ PE-5000 Series (5mm trocar and cannula systems);

(b) PrecisionEdge™ PE-12000 Series (12mm trocar and cannula systems);

(d) Any successor, replacement, next-generation, improved, modified, or derivative products of any of the foregoing product lines, whether sold under the PrecisionEdge™ brand name or under any other brand name, trademark, or trade designation,

in each case, solely to the extent that such product, device, system, component, or assembly falls within the Licensed Field. For the avoidance of doubt, the term "Covered Products" shall include any Covered Product regardless of the specific model number, version, revision, or variant thereof, provided that it falls within the Licensed Field.

1.5 "Licensed Field" means laparoscopic surgical access devices, as more fully defined in Section 1.12 of the Patent License Agreement (Exhibit A to the Settlement Agreement). The Licensed Field includes, without limitation, trocars, cannulas, obturators, access ports, and related sealing assemblies used in minimally invasive laparoscopic surgical procedures.

1.6 "Term" means the period commencing on the Effective Date and continuing until the later of: (a) the date of expiration, invalidation, or abandonment of the last-to-expire patent within the Apex Trocar Patent Family (taking into account any extensions of term granted by applicable governmental authorities); or (b) the date of termination of the Patent License Agreement in accordance with its terms. For the avoidance of doubt, if the Patent License Agreement is terminated prior to the expiration of the last-to-expire patent within the Apex Trocar Patent Family, this Covenant shall nonetheless continue in effect until the expiration of such last-to-expire patent, subject to the exceptions and limitations set forth in Section 4 hereof.

1.7 "Effective Date" means the date of execution of this Covenant Not to Sue by all Parties, which is the date first written above, June 16, 2025.

SECTION 2 — COVENANT NOT TO SUE

2.1 Grant of Covenant. Apex Surgical Innovations, Inc., on behalf of itself and its officers, directors, employees, agents, successors, and assigns, hereby irrevocably covenants, promises, and agrees that it shall not, at any time during the Term, directly or indirectly, whether alone or in concert or combination with any third party, and whether by action, inaction, or otherwise:

(a) bring, commence, initiate, file, or institute any action, lawsuit, suit, proceeding, complaint, claim, demand, petition, or investigation (whether civil, criminal, or administrative);

(b) maintain, continue, or prosecute any action, lawsuit, suit, proceeding, complaint, claim, demand, petition, or investigation previously filed or initiated;

(c) voluntarily participate in, assist, encourage, fund, or support any action, lawsuit, suit, proceeding, complaint, claim, demand, petition, or investigation brought or initiated by any third party; or

(d) threaten, in writing or otherwise, to take any of the actions described in subsections (a) through (c) above,

in any forum, including without limitation in any federal or state court, before the United States International Trade Commission, in any arbitration or mediation proceeding, before the United States Patent and Trademark Office (including in inter partes review, post-grant review, covered business method review, or ex parte reexamination proceedings), or before any other tribunal, administrative body, or governmental authority, whether domestic or foreign, against any Covenantee Entity, asserting or alleging infringement, contributory infringement, inducement of infringement, or any other theory of patent infringement (whether direct or indirect), of any patent or patent application within the Apex Trocar Patent Family, with respect to the manufacture, having made, use, sale, offer to sell, offer for sale, distribution, or importation of Covered Products within the Licensed Field.

2.2 Scope — All Patents in Family. The Parties acknowledge and agree that this Covenant extends to all fourteen (14) issued United States patents and all six (6) pending United States continuation applications within the Apex Trocar Patent Family as identified on Exhibit C to the Settlement Agreement, and to any and all patents that may issue from such pending applications during the Term. The Parties further acknowledge and agree that the scope of this Covenant is not limited to the three Asserted Patents (the '237 Patent, the '884 Patent, and the '105 Patent) that were the subject of the Litigation, but encompasses the entirety of the Apex Trocar Patent Family as defined in Section 1.2 hereof. This broader scope is a material term of the settlement and a material inducement for the Solstice Entities to enter into the Settlement Agreement and to make the payments contemplated thereby.

2.3 Scope — Covered Activities. The covenant set forth in Section 2.1 covers the making, having made, using, selling, offering for sale, distributing, marketing, promoting, importing, and exporting of Covered Products by or on behalf of any Covenantee Entity, including without limitation:

(a) Covered Products manufactured directly by any Covenantee Entity at its own facilities;

(b) Covered Products manufactured by authorized contract manufacturers, original equipment manufacturers, or other third-party manufacturers acting under the authority of, on behalf of, and at the direction of any Covenantee Entity, to the extent such manufacturing activities are authorized under the sublicense or "have made" rights set forth in the Patent License Agreement;

(c) Covered Products sold or distributed by authorized distributors, dealers, resellers, agents, or sales representatives of any Covenantee Entity; and

(d) Covered Products used by end users (including hospitals, surgical centers, clinics, physicians, and other healthcare providers) who have purchased or otherwise lawfully obtained Covered Products from any Covenantee Entity or its authorized distributors.

2.4 Scope — Geographic. This Covenant is worldwide in scope, to the extent that the Apex Trocar Patent Family includes patents or patent applications in any jurisdiction. The Parties acknowledge that, as of the Effective Date, the Apex Trocar Patent Family consists primarily of United States patents and United States patent applications. To the extent that Apex owns or controls foreign counterpart patents or patent applications corresponding to any patent or patent application within the Apex Trocar Patent Family, whether now existing or hereafter acquired or obtained, this Covenant shall extend to such foreign counterpart patents and patent applications in the same manner and to the same extent as it applies to the United States patents and patent applications within the Apex Trocar Patent Family. Apex represents that, as of the Effective Date, it is not aware of any foreign counterpart patents or patent applications within the Apex Trocar Patent Family other than those, if any, identified on Exhibit C to the Settlement Agreement.

SECTION 3 — EXTENSION TO SUBSIDIARIES AND CONTRACT MANUFACTURERS

3.1 Current and Future Subsidiaries. The covenant set forth in Section 2 extends to and for the benefit of all current and future direct and indirect subsidiaries of Solstice Biomedical Devices Ltd. and Solstice Biomedical, Inc., whether now existing or hereafter formed, organized, or acquired during the Term, for so long as such entities remain subsidiaries of either Solstice Parent or Solstice US. For purposes of this Section 3.1, an entity shall be deemed a "subsidiary" of Solstice Parent or Solstice US if Solstice Parent or Solstice US, directly or indirectly, owns or controls more than fifty percent (50%) of the outstanding voting securities or voting equity interests of such entity, or otherwise has the power to direct or cause the direction of the management and policies of such entity, whether through ownership of voting securities, by contract, or otherwise. In the event that an entity ceases to be a subsidiary of either Solstice Parent or Solstice US during the Term (whether by reason of divestiture, sale, spin-off, or otherwise), the benefits of this Covenant shall cease to apply to such entity as of the date on which it ceases to be a subsidiary, and such entity shall thereafter have no further rights or protections under this Covenant.

3.2 Contract Manufacturers. The covenant set forth in Section 2 extends to and for the benefit of contract manufacturers, original equipment manufacturers, and other third-party manufacturers of Covered Products acting under the authority of, on behalf of, and at the direction of any Covenantee Entity, solely to the extent that:

(a) such contract manufacturing activities fall within the Licensed Field;

(b) such contract manufacturing activities are authorized under the sublicense or "have made" rights set forth in the Patent License Agreement (Exhibit A); and

(c) the Covered Products manufactured by such contract manufacturers are manufactured exclusively for sale by or on behalf of the Covenantee Entities.

For the avoidance of doubt, this Covenant does not extend to any contract manufacturer with respect to products manufactured by such contract manufacturer for its own account or for the account of any third party other than a Covenantee Entity. The Solstice Entities shall maintain a current list of authorized contract manufacturers benefiting from this Section 3.2 and shall provide such list to Apex upon reasonable written request, subject to appropriate confidentiality protections.

SECTION 4 — EXCEPTIONS AND LIMITATIONS

4.1 Material Breach Carve-Out. Notwithstanding anything to the contrary in this Covenant, the covenant set forth in Section 2 shall not preclude or prevent Apex from bringing, commencing, or maintaining an action for patent infringement against any Covenantee Entity in the event that any Solstice Entity commits a material breach of the Settlement Agreement or the Patent License Agreement, and such material breach remains uncured after the expiration of the applicable notice and cure period specified in the Settlement Agreement or the Patent License Agreement, as the case may be; provided, however, that Apex shall not bring, commence, or maintain any such action unless and until Apex has first:

(a) provided written notice of the material breach to the breaching Solstice Entity in accordance with the notice provisions of the Settlement Agreement, specifying in reasonable detail the nature of the breach and the actions required to cure such breach;

(b) allowed the applicable cure period (as specified in the Settlement Agreement or the Patent License Agreement, as applicable) to expire without such breach being cured to Apex's reasonable satisfaction; and

(c) terminated the Patent License Agreement in accordance with the termination provisions set forth therein, effective as of the date specified in the notice of termination.

For the avoidance of doubt, a failure by any Solstice Entity to make any payment when due under the Settlement Agreement or the Patent License Agreement shall constitute a material breach for purposes of this Section 4.1 only if such failure continues for a period of more than thirty (30) days following written notice from Apex specifying such failure. The Parties acknowledge that the exercise of Apex's rights under this Section 4.1 is subject to the dispute resolution provisions of the Settlement Agreement, including any mandatory mediation or arbitration provisions contained therein.

4.2 Outside Licensed Field. This Covenant applies solely and exclusively to Covered Products within the Licensed Field (i.e., laparoscopic surgical access devices, as defined in Section 1.5 hereof and in the Patent License Agreement). This Covenant does not extend to, and shall not be construed to cover, any products, devices, systems, components, or activities that fall outside the Licensed Field. Apex expressly retains all rights to enforce any and all patents and patent applications within the Apex Trocar Patent Family against any Covenantee Entity (or any other person or entity) with respect to any products or activities that are outside the Licensed Field, including without limitation products or devices used in open surgery, robotic surgery (other than laparoscopic robotic surgery to the extent included within the Licensed Field as defined in the Patent License Agreement), or any other field of use not encompassed within the Licensed Field. Nothing in this Covenant shall be deemed to constitute a license, covenant not to sue, or other grant of rights with respect to any products or activities outside the Licensed Field.

4.3 Change of Control. In the event of a Change of Control (as defined in the Patent License Agreement) of Solstice Biomedical Devices Ltd. or Solstice Biomedical, Inc., the following provisions shall apply:

(a) This Covenant shall continue to apply to the Covenantee Entities on the same terms and conditions set forth herein, subject to and in accordance with the transferability and assignment provisions of the Patent License Agreement (including any consent requirements set forth therein).

(b) This Covenant shall not extend to the acquiring entity or its affiliates (other than the Covenantee Entities) with respect to any pre-existing products of the acquiring entity that are not Covered Products as defined herein. For the avoidance of doubt, if the acquiring entity or any of its affiliates (other than the Covenantee Entities) manufactures, uses, sells, offers for sale, or imports products that fall within the scope of the Apex Trocar Patent Family but are not Covered Products, this Covenant shall not provide any protection or immunity to the acquiring entity or such affiliates with respect to such products.

(c) The Solstice Entities shall provide written notice to Apex of any Change of Control within fifteen (15) business days of the closing of the transaction giving rise to such Change of Control, in accordance with the notice provisions set forth in Section 9.6 hereof.

4.4 Third-Party Claims. Nothing in this Covenant shall restrict, limit, or otherwise affect Apex's right to assert, enforce, license, or otherwise exercise any of its rights with respect to any patent or patent application within the Apex Trocar Patent Family against any person or entity that is not a Covenantee Entity (as defined herein). Apex retains all rights to bring, commence, initiate, maintain, or prosecute any action, lawsuit, proceeding, complaint, claim, or demand against any third party for infringement of any patent within the Apex Trocar Patent Family, and this Covenant shall not be construed as a waiver, release, or abandonment of any such rights.

SECTION 5 — REPRESENTATIONS AND WARRANTIES OF APEX

Apex hereby represents and warrants to each of the Covenantee Entities as follows:

5.1 Ownership. Apex represents and warrants that, as of the Effective Date, it is the sole and exclusive owner of the entire right, title, and interest in and to each and every patent and patent application within the Apex Trocar Patent Family, including without limitation the '237 Patent, the '884 Patent, and the '105 Patent. All such patents and patent applications are duly and validly assigned to Apex Surgical Innovations, Inc., and all assignments have been duly recorded with the United States Patent and Trademark Office. No other person or entity has any ownership interest, co-ownership interest, or right of any kind in or to any patent or patent application within the Apex Trocar Patent Family, other than the licenses and rights granted under the Patent License Agreement and this Covenant.

5.2 Authority. Apex represents and warrants that it has full corporate power and authority to enter into, execute, and deliver this Covenant Not to Sue and to perform all of its obligations hereunder. The execution, delivery, and performance of this Covenant have been duly authorized by all necessary corporate action on the part of Apex, including any required approvals of the board of directors of Apex. The person executing this Covenant on behalf of Apex is duly authorized to do so.

5.3 No Prior Inconsistent Grants. Apex represents and warrants that, as of the Effective Date, it has not previously granted, assigned, transferred, conveyed, pledged, or encumbered any rights, licenses, immunities, covenants not to sue, or other grants or interests with respect to any patent or patent application within the Apex Trocar Patent Family that would be inconsistent with, contrary to, or that would impair, diminish, or render unenforceable, in whole or in part, the rights, protections, and benefits granted to the Covenantee Entities under this Covenant Not to Sue. Apex further represents and warrants that there are no outstanding agreements, arrangements, or understandings with any third party that would prevent or impair Apex's ability to fully perform its obligations under this Covenant.

5.4 No Encumbrances. Apex represents and warrants that, as of the Effective Date, the patents and patent applications in the Apex Trocar Patent Family are free and clear of any and all liens, mortgages, pledges, security interests, charges, encumbrances, restrictions, or claims of any kind or nature whatsoever (collectively, "Encumbrances") that would impair, diminish, or prevent Apex's ability to grant and perform the covenant set forth herein. In the event that Apex grants any security interest or lien in or to any patent or patent application within the Apex Trocar Patent Family after the Effective Date, Apex shall ensure that such security interest or lien is expressly made subject to and subordinate to the terms and conditions of this Covenant.

SECTION 6 — SUCCESSORS AND ASSIGNS

6.1 Binding on Successors. This Covenant Not to Sue shall be binding upon and shall inure to the benefit of the Parties and their respective successors, assigns, heirs, and legal representatives. Without limiting the generality of the foregoing, any assignee, transferee, or other successor-in-interest to any patent or patent application within the Apex Trocar Patent Family shall take and hold such patent or patent application subject to the terms and conditions of this Covenant Not to Sue. Apex hereby covenants and agrees that, in the event of any assignment, transfer, sale, conveyance, or other disposition (whether voluntary or involuntary, by operation of law or otherwise) of any patent or patent application within the Apex Trocar Patent Family to any third party, Apex shall ensure that:

(a) the instrument of assignment, transfer, or conveyance contains an express written acknowledgment by the assignee, transferee, or successor-in-interest that such assignee, transferee, or successor-in-interest has received a copy of this Covenant and agrees to be bound by and to comply with the terms and conditions of this Covenant to the same extent as Apex; and

(b) Apex provides a fully executed copy of such instrument to the Solstice Entities promptly following execution thereof, and in any event within the time period specified in Section 6.2 below.

Any purported assignment or transfer of any patent or patent application within the Apex Trocar Patent Family that does not comply with the requirements of this Section 6.1 shall not relieve Apex of any of its obligations under this Covenant and shall not impair or diminish the rights and protections of the Covenantee Entities hereunder.

6.2 Notice of Assignment. Apex shall provide written notice to the Solstice Entities within thirty (30) calendar days of any assignment, transfer, sale, conveyance, or other disposition of any patent or patent application within the Apex Trocar Patent Family. Such notice shall identify the patent(s) or patent application(s) assigned or transferred, the identity and contact information of the assignee or transferee, and the effective date of the assignment or transfer. Such notice shall be delivered in accordance with the notice provisions set forth in Section 9.6 hereof.

SECTION 7 — RELATIONSHIP TO SETTLEMENT AGREEMENT AND PATENT LICENSE AGREEMENT

7.1 Integral Part of Settlement. The Parties acknowledge and agree that this Covenant Not to Sue is an integral part of the overall settlement of the Litigation (Case No. 1:24-cv-00587-RGA, Apex Surgical Innovations, Inc. v. Solstice Biomedical, Inc., in the United States District Court for the District of Delaware) and is delivered in connection with and as part of the consideration set forth in the Settlement Agreement. This Covenant is not a standalone agreement but rather a component of a comprehensive settlement that includes the Settlement Agreement, the Patent License Agreement (Exhibit A), and the other Exhibits to the Settlement Agreement. The Parties further acknowledge that this Covenant was a material inducement for the Solstice Entities to enter into the Settlement Agreement and to agree to the financial terms set forth therein.

7.2 Complementary to Patent License Agreement. This Covenant Not to Sue is complementary to, and not in limitation of, the rights and licenses granted under the Patent License Agreement (Exhibit A to the Settlement Agreement). The protections afforded by this Covenant are intended to supplement and reinforce the rights granted under the Patent License Agreement and to provide the Covenantee Entities with the broadest possible protection from patent infringement claims relating to the Apex Trocar Patent Family with respect to Covered Products within the Licensed Field. In the event of any conflict, ambiguity, or inconsistency between the terms of this Covenant Not to Sue and the terms of the Patent License Agreement, the provision that provides the broader protection, immunity, or benefit to the Covenantee Entities shall control with respect to the scope of the covenant and the extent of the protection afforded to the Covenantee Entities.

7.3 Survival. The covenants, agreements, representations, and warranties set forth in this Covenant shall survive the dismissal of the Litigation (Case No. 1:24-cv-00587-RGA) with prejudice pursuant to the Stipulation of Dismissal attached as Exhibit E to the Settlement Agreement, and shall remain in full force and effect for the duration of the Term regardless of such dismissal. The Parties intend that the filing of the Stipulation of Dismissal shall in no way diminish, impair, or affect the enforceability of this Covenant.

SECTION 8 — REMEDIES

8.1 Injunctive Relief. The Parties acknowledge and agree that a breach or threatened breach of this Covenant Not to Sue by Apex would cause irreparable harm to the Covenantee Entities for which monetary damages would be an inadequate remedy. Accordingly, in the event of a breach or threatened breach of this Covenant Not to Sue by Apex (or by any successor or assign of Apex), any Covenantee Entity shall be entitled to seek and obtain specific performance and injunctive relief (including temporary restraining orders, preliminary injunctions, and permanent injunctions) in any court of competent jurisdiction, in addition to and not in limitation of any other remedies available at law or in equity. Such injunctive relief may be sought without the necessity of proving actual damages or irreparable harm (which shall be presumed) and without the requirement of posting a bond or other security (or, if a bond or security is required by applicable law, such bond or security shall be in the minimum amount permitted by law).

8.2 Attorneys' Fees. In any action, suit, or proceeding brought to enforce the terms of this Covenant Not to Sue, or to obtain damages or other relief for any breach or threatened breach hereof, the prevailing party (as determined by the court) shall be entitled to recover from the non-prevailing party its reasonable attorneys' fees, expert witness fees, court costs, and other litigation expenses incurred in connection with such action, suit, or proceeding, including any appeal thereof.

SECTION 9 — GENERAL PROVISIONS

9.1 Governing Law. This Covenant Not to Sue shall be governed by, construed in accordance with, and enforced under the laws of the State of Delaware, without giving effect to any choice-of-law or conflict-of-laws rules, principles, or provisions (whether of the State of Delaware or any other jurisdiction) that would cause the application of the laws of any jurisdiction other than the State of Delaware. Notwithstanding the foregoing, all questions relating to the validity, enforceability, construction, and infringement of United States patents shall be governed by and construed in accordance with the patent laws of the United States (Title 35 of the United States Code).

9.2 Jurisdiction and Venue. Any dispute, controversy, claim, or cause of action arising out of, relating to, or in connection with this Covenant Not to Sue, including any question regarding the existence, validity, interpretation, performance, breach, or termination of this Covenant, shall be subject to the exclusive jurisdiction of the United States District Court for the District of Delaware. In the event that such court lacks subject-matter jurisdiction, jurisdiction shall lie exclusively in the courts of the State of Delaware sitting in Wilmington, New Castle County, Delaware. Each Party hereby irrevocably and unconditionally (a) consents and submits to the personal jurisdiction of such courts, (b) waives any objection that it may now or hereafter have to the laying of venue in such courts, and (c) waives any claim or defense of inconvenient forum with respect to any action, suit, or proceeding brought in such courts.

9.3 Entire Agreement. This Covenant Not to Sue, together with the Settlement Agreement, the Patent License Agreement (Exhibit A to the Settlement Agreement), and the other Exhibits thereto, constitutes the entire agreement of the Parties with respect to the subject matter hereof and supersedes all prior and contemporaneous negotiations, discussions, proposals, agreements, representations, warranties, and understandings of the Parties, whether written or oral, relating to the subject matter hereof. No Party has relied on any statement, representation, warranty, or agreement of any other Party except as expressly set forth herein or in the Settlement Agreement and the Patent License Agreement. The Term Sheet dated June 10, 2025 is superseded in its entirety by the Settlement Agreement, the Patent License Agreement, and this Covenant, and shall have no further force or effect.

9.4 Amendment. This Covenant Not to Sue may not be amended, modified, supplemented, or waived except by a written instrument that (a) expressly refers to this Covenant Not to Sue, (b) sets forth the specific provision(s) being amended, modified, supplemented, or waived, and (c) is duly executed by an authorized representative of each Party hereto. No oral agreement or course of dealing shall be effective to amend, modify, or waive any provision of this Covenant.

9.5 Severability. If any provision of this Covenant Not to Sue, or the application of any provision to any person, entity, or circumstance, is held by a court of competent jurisdiction to be invalid, illegal, void, or unenforceable in any respect, such invalidity, illegality, or unenforceability shall not affect any other provision hereof or the application of such provision to any other person, entity, or circumstance, and the remaining provisions of this Covenant shall remain in full force and effect and shall be construed and enforced as if such invalid, illegal, or unenforceable provision had not been included herein. The Parties shall use commercially reasonable efforts to negotiate and agree upon a valid, legal, and enforceable substitute provision that most nearly achieves the intent and economic effect of the invalid, illegal, or unenforceable provision.

9.6 Notices. All notices, requests, demands, consents, approvals, and other communications required or permitted to be given under this Covenant Not to Sue shall be in writing and shall be deemed duly given and effective upon delivery if delivered in accordance with the notice provisions of the Settlement Agreement. Without limiting the generality of the foregoing, notices shall be addressed as follows:

If to Apex:

Apex Surgical Innovations, Inc. 1220 North Market Street, Suite 550 Wilmington, Delaware 19801

Attention: Martin Hale, General Counsel

Email: mhale@apexsurgical.com

With a copy (which shall not constitute notice) to:

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

Email: vstanton@htblaw.com

If to Solstice Biomedical Devices Ltd.:

Solstice Biomedical Devices Ltd. Unit 14, Clonskeagh Business Park Clonskeagh Road, Dublin 14 D14 YF28, Ireland

Attention: Eamon Rourke, General Counsel

Email: erourke@solsticebiomedical.com

With a copy (which shall not constitute notice) to:

Marcus Delgado, Esq. Calderwood & Harkness LLP 1201 Market Street, Suite 2500 Wilmington, Delaware 19801

Email: mdelgado@calderwoodharkness.com

If to Solstice Biomedical, Inc.:

Solstice Biomedical, Inc. 3800 Concord Pike, Suite 410 Wilmington, Delaware 19803

Attention: General Counsel

Email: legal@solsticebiomedical.com

Any Party may change its address for notices by giving written notice of such change to the other Parties in accordance with this Section 9.6.

9.7 Counterparts. This Covenant Not to Sue may be executed in any number of counterparts, each of which shall be deemed an original and all of which, taken together, shall constitute one and the same instrument. Delivery of an executed counterpart of this Covenant by facsimile transmission, by electronic mail in portable document format (.pdf), or by any other electronic means intended to preserve the original graphic and pictorial appearance of a document shall have the same effect as delivery of an originally executed counterpart. Electronic signatures (including signatures transmitted via Brightwater Software, Ashford Health IT, or similar electronic signature platforms) shall be deemed valid and binding for all purposes and shall have the same legal effect as original ink signatures.

9.8 No Third-Party Beneficiaries. Except as expressly provided in Section 3 hereof with respect to subsidiaries and contract manufacturers of the Covenantee Entities, this Covenant Not to Sue is intended solely for the benefit of the Parties hereto and their respective successors and permitted assigns, and does not confer any rights, remedies, obligations, or causes of action upon any person or entity other than the Parties hereto and their respective successors and permitted assigns. No person or entity that is not a Party to this Covenant shall have standing to enforce any provision of this Covenant or to assert any claim arising out of or in connection with this Covenant.

9.9 Waiver. No failure or delay by any Party in exercising any right, power, or privilege under this Covenant Not to Sue shall operate as a waiver thereof, nor shall any single or partial exercise of any such right, power, or privilege preclude any other or further exercise thereof or the exercise of any other right, power, or privilege. All rights and remedies provided in this Covenant are cumulative and are not exclusive of any other rights or remedies provided by law, in equity, or otherwise.

[SIGNATURE PAGE FOLLOWS]

IN WITNESS WHEREOF, the Parties have caused this Covenant Not to Sue to be executed by their respective duly authorized representatives as of the date first written above.

APEX SURGICAL INNOVATIONS, INC. (Covenantor)

By: ________

Name: Gerald K. Whitford

Title: Chief Executive Officer

Date: June 16, 2025

SOLSTICE BIOMEDICAL DEVICES LTD. (Covenantee)

By: ________

Name: Dr. Fiona Tierney

Title: Chief Executive Officer

Date: June 16, 2025

SOLSTICE BIOMEDICAL, INC. (Covenantee)

By: ________

Name: Eamon Rourke

Title: General Counsel (Authorized Signatory)

Date: June 16, 2025

ACKNOWLEDGED BY COUNSEL:

For Apex Surgical Innovations, Inc.:

________________________________________

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

For Solstice Biomedical Devices Ltd. and Solstice Biomedical, Inc.:

________________________________________

Marcus Delgado, Esq. Calderwood & Harkness LLP 1201 Market Street, Suite 2500 Wilmington, Delaware 19801

CONFIDENTIAL — This Exhibit B constitutes a confidential settlement document subject to the confidentiality provisions of the Settlement Agreement and Mutual Release dated June 16, 2025.

EXHIBIT B
COVENANT NOT TO SUE
June 16, 2025
Exhibit B to the Settlement Agreement and Mutual Release dated June 16, 2025 (the "Settlement Agreement") by and among Solstice Biomedical Devices Ltd., Solstice Biomedical, Inc., and Apex Surgical Innovations, Inc.
This COVENANT NOT TO SUE (this "Covenant") is made and entered into as of June 16, 2025 (the "Effective Date"), by and among:
Apex Surgical Innovations, Inc., a corporation organized and existing under the laws of the State of Delaware, with its principal office located at 1220 North Market Street, Suite 550, Wilmington, Delaware 19801 (EIN: 51-0483762) (hereinafter referred to as "Covenantor" or "Apex");
and
Solstice Biomedical Devices Ltd., a private limited company organized and existing under the laws of Ireland (Companies Registration Office No. 648217), with its registered office at Unit 14, Clonskeagh Business Park, Clonskeagh Road, Dublin 14, D14 YF28, Ireland (hereinafter referred to as "Solstice Parent");
and
Solstice Biomedical, Inc., a corporation organized and existing under the laws of the State of Delaware (EIN: 84-3291056), with its principal offices at 3800 Concord Pike, Suite 410, Wilmington, Delaware 19803 (hereinafter referred to as "Solstice US").
Solstice Parent and Solstice US are hereinafter collectively referred to as the "Covenantees" or the "Solstice Entities." Apex, Solstice Parent, and Solstice US are hereinafter individually referred to as a "Party" and collectively as the "Parties."
RECITALS
WHEREAS:
A. The Litigation. On May 9, 2024, Apex filed a complaint against Solstice Biomedical, Inc. in the United States District Court for the District of Delaware, Case No. 1:24-cv-00587-RGA, captioned Apex Surgical Innovations, Inc. v. Solstice Biomedical, Inc., before the Honorable Chief Judge Richard G. Andrews (the "Litigation"), alleging infringement of United States Patent Nos. 9,814,237 (the "'237 Patent"), 10,271,884 (the "'884 Patent"), and 10,932,105 (the "'105 Patent") (collectively, the "Asserted Patents"). The Litigation involves claims of direct infringement, contributory infringement, and inducement of infringement arising out of the manufacture, use, sale, offer for sale, and importation of certain laparoscopic surgical access devices marketed by Solstice US under the PrecisionEdge™ product line;
B. The Settlement Agreement. The Parties have entered into a Settlement Agreement and Mutual Release dated June 16, 2025 (the "Settlement Agreement"), pursuant to which the Parties have agreed to fully, finally, and irrevocably resolve all claims, counterclaims, defenses, and disputes between and among them in the Litigation, and to dismiss the Litigation with prejudice in accordance with a Stipulation of Dismissal to be filed with the Court;
C. The Patent License Agreement. In connection with the Settlement Agreement, Apex has granted to Solstice Biomedical, Inc. and Solstice Biomedical Devices Ltd. a non-exclusive license under the Licensed Patents (as defined therein), as set forth in the Patent License Agreement (Non-Exclusive) attached as Exhibit A to the Settlement Agreement (the "Patent License Agreement"), which Patent License Agreement sets forth the terms and conditions of the license, including the scope of the Licensed Field, sublicense rights, and royalty obligations;
D. The Term Sheet. The Parties previously executed a binding Term Sheet dated June 10, 2025 (the "Term Sheet"), setting forth the principal terms upon which the Parties agreed to settle the Litigation, including, among other things, the covenant not to sue contemplated by this Covenant. The Settlement Agreement, the Patent License Agreement, and this Covenant are intended to memorialize and implement the terms set forth in the Term Sheet;
E. Consideration. This Covenant Not to Sue is delivered as part of the consideration for the Settlement Agreement. The consideration for the Settlement Agreement includes, without limitation: (i) a lump-sum payment by the Solstice Entities to Apex in the aggregate amount of Eight Million Seven Hundred Fifty Thousand Dollars ($8,750,000), payable in two tranches — Tranche 1 in the amount of Five Million Two Hundred Fifty Thousand Dollars ($5,250,000), due and payable on or before June 30, 2025, and Tranche 2 in the amount of Three Million Five Hundred Thousand Dollars ($3,500,000), due and payable on or before September 15, 2025; and (ii) a running royalty of three and three-quarters percent (3.75%) of Net Sales of Licensed Products (as such terms are defined in the Patent License Agreement), payable in accordance with the terms and schedule set forth in the Patent License Agreement. The Parties acknowledge that this Covenant constitutes a material inducement for the Solstice Entities to enter into the Settlement Agreement and the Patent License Agreement and to make the payments described herein.
NOW, THEREFORE, in consideration of the foregoing recitals (which are incorporated herein by reference as material terms of this Covenant), the mutual covenants and agreements set forth herein, the consideration set forth in the Settlement Agreement, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:
SECTION 1 — DEFINITIONS
1.1 Defined Terms. Capitalized terms used but not otherwise defined in this Covenant shall have the meanings ascribed to such terms in the Settlement Agreement or the Patent License Agreement (Exhibit A to the Settlement Agreement), as applicable. In the event that a term is defined in both the Settlement Agreement and the Patent License Agreement, and such definitions are inconsistent, the definition set forth in the Settlement Agreement shall control for purposes of this Covenant unless the context requires otherwise.
1.2 "Apex Trocar Patent Family" means the portfolio of patents and patent applications owned or controlled by Apex Surgical Innovations, Inc. relating to trocar and surgical access device technology, consisting of the following:
(a) Fourteen (14) issued United States patents, including but not limited to:
(i) U.S. Patent No. 9,814,237, entitled "Locking Seal Assembly for Minimally Invasive Surgical Access Device," issued November 14, 2017, with an expiration date of June 22, 2035 (the "'237 Patent");
(ii) U.S. Patent No. 10,271,884, entitled "Retractable Blade Deployment Mechanism for Trocar Systems," issued April 30, 2019, with an expiration date of September 15, 2036 (the "'884 Patent");
(iii) U.S. Patent No. 10,932,105, entitled "Integrated Insufflation Valve and Seal for Laparoscopic Trocar," issued March 2, 2021, with an expiration date of January 10, 2038 (the "'105 Patent"); and
(iv) The remaining eleven (11) issued United States patents as listed and identified on Exhibit C to the Settlement Agreement (the "Exhibit C Patent List"), which Exhibit C Patent List is incorporated herein by reference;
(b) Six (6) pending United States continuation applications, as listed and identified on Exhibit C to the Settlement Agreement;
(c) Any and all patents issuing from such pending applications described in subsection (b) above during the Term, including any patents issuing from continuations, continuations-in-part, divisional applications, reissue applications, reexamination proceedings, inter partes review proceedings, or post-grant review proceedings relating to any of the foregoing patents or patent applications, to the extent owned or controlled by Apex during the Term;
(d) Any and all extensions, supplementary protection certificates, or other statutory extensions of term applicable to any of the foregoing patents, to the extent owned or controlled by Apex during the Term; and
(e) Any foreign counterpart patents or patent applications corresponding to any of the foregoing, to the extent owned or controlled by Apex during the Term.
The Parties acknowledge that the named inventor on the Asserted Patents and the principal inventor within the Apex Trocar Patent Family is Dr. Raymond Szabo, Vice President of Engineering at Apex Surgical Innovations, Inc. Nothing herein shall be construed to grant any rights with respect to inventions or patents that are not within the Apex Trocar Patent Family as defined herein.
1.3 "Covenantee Entities" means (a) Solstice Biomedical Devices Ltd.; (b) Solstice Biomedical, Inc.; and (c) any direct or indirect subsidiary, parent, or affiliate of either of the foregoing entities, now existing or hereafter formed, organized, or acquired during the Term, for so long as such entity qualifies as a subsidiary, parent, or affiliate of either Solstice Parent or Solstice US. For purposes of this Section 1.3, the term "affiliate" shall have the meaning ascribed to it in the Patent License Agreement.
1.4 "Covered Products" means any product, device, system, component, or assembly that falls within the Licensed Field, including but not limited to the following product lines currently manufactured, marketed, or sold by or on behalf of any Covenantee Entity:
(a) PrecisionEdge™ PE-5000 Series (5mm trocar and cannula systems);
(b) PrecisionEdge™ PE-12000 Series (12mm trocar and cannula systems);
(c) PrecisionEdge™ PE-15000 Series (15mm trocar and cannula systems); and
(d) Any successor, replacement, next-generation, improved, modified, or derivative products of any of the foregoing product lines, whether sold under the PrecisionEdge™ brand name or under any other brand name, trademark, or trade designation,
in each case, solely to the extent that such product, device, system, component, or assembly falls within the Licensed Field. For the avoidance of doubt, the term "Covered Products" shall include any Covered Product regardless of the specific model number, version, revision, or variant thereof, provided that it falls within the Licensed Field.
1.5 "Licensed Field" means laparoscopic surgical access devices, as more fully defined in Section 1.12 of the Patent License Agreement (Exhibit A to the Settlement Agreement). The Licensed Field includes, without limitation, trocars, cannulas, obturators, access ports, and related sealing assemblies used in minimally invasive laparoscopic surgical procedures.
1.6 "Term" means the period commencing on the Effective Date and continuing until the later of: (a) the date of expiration, invalidation, or abandonment of the last-to-expire patent within the Apex Trocar Patent Family (taking into account any extensions of term granted by applicable governmental authorities); or (b) the date of termination of the Patent License Agreement in accordance with its terms. For the avoidance of doubt, if the Patent License Agreement is terminated prior to the expiration of the last-to-expire patent within the Apex Trocar Patent Family, this Covenant shall nonetheless continue in effect until the expiration of such last-to-expire patent, subject to the exceptions and limitations set forth in Section 4 hereof.
1.7 "Effective Date" means the date of execution of this Covenant Not to Sue by all Parties, which is the date first written above, June 16, 2025.
SECTION 2 — COVENANT NOT TO SUE
2.1 Grant of Covenant. Apex Surgical Innovations, Inc., on behalf of itself and its officers, directors, employees, agents, successors, and assigns, hereby irrevocably covenants, promises, and agrees that it shall not, at any time during the Term, directly or indirectly, whether alone or in concert or combination with any third party, and whether by action, inaction, or otherwise:
(a) bring, commence, initiate, file, or institute any action, lawsuit, suit, proceeding, complaint, claim, demand, petition, or investigation (whether civil, criminal, or administrative);
(b) maintain, continue, or prosecute any action, lawsuit, suit, proceeding, complaint, claim, demand, petition, or investigation previously filed or initiated;
(c) voluntarily participate in, assist, encourage, fund, or support any action, lawsuit, suit, proceeding, complaint, claim, demand, petition, or investigation brought or initiated by any third party; or
(d) threaten, in writing or otherwise, to take any of the actions described in subsections (a) through (c) above,
in any forum, including without limitation in any federal or state court, before the United States International Trade Commission, in any arbitration or mediation proceeding, before the United States Patent and Trademark Office (including in inter partes review, post-grant review, covered business method review, or ex parte reexamination proceedings), or before any other tribunal, administrative body, or governmental authority, whether domestic or foreign, against any Covenantee Entity, asserting or alleging infringement, contributory infringement, inducement of infringement, or any other theory of patent infringement (whether direct or indirect), of any patent or patent application within the Apex Trocar Patent Family, with respect to the manufacture, having made, use, sale, offer to sell, offer for sale, distribution, or importation of Covered Products within the Licensed Field.
2.2 Scope — All Patents in Family. The Parties acknowledge and agree that this Covenant extends to all fourteen (14) issued United States patents and all six (6) pending United States continuation applications within the Apex Trocar Patent Family as identified on Exhibit C to the Settlement Agreement, and to any and all patents that may issue from such pending applications during the Term. The Parties further acknowledge and agree that the scope of this Covenant is not limited to the three Asserted Patents (the '237 Patent, the '884 Patent, and the '105 Patent) that were the subject of the Litigation, but encompasses the entirety of the Apex Trocar Patent Family as defined in Section 1.2 hereof. This broader scope is a material term of the settlement and a material inducement for the Solstice Entities to enter into the Settlement Agreement and to make the payments contemplated thereby.
2.3 Scope — Covered Activities. The covenant set forth in Section 2.1 covers the making, having made, using, selling, offering for sale, distributing, marketing, promoting, importing, and exporting of Covered Products by or on behalf of any Covenantee Entity, including without limitation:
(a) Covered Products manufactured directly by any Covenantee Entity at its own facilities;
(b) Covered Products manufactured by authorized contract manufacturers, original equipment manufacturers, or other third-party manufacturers acting under the authority of, on behalf of, and at the direction of any Covenantee Entity, to the extent such manufacturing activities are authorized under the sublicense or "have made" rights set forth in the Patent License Agreement;
(c) Covered Products sold or distributed by authorized distributors, dealers, resellers, agents, or sales representatives of any Covenantee Entity; and
(d) Covered Products used by end users (including hospitals, surgical centers, clinics, physicians, and other healthcare providers) who have purchased or otherwise lawfully obtained Covered Products from any Covenantee Entity or its authorized distributors.
2.4 Scope — Geographic. This Covenant is worldwide in scope, to the extent that the Apex Trocar Patent Family includes patents or patent applications in any jurisdiction. The Parties acknowledge that, as of the Effective Date, the Apex Trocar Patent Family consists primarily of United States patents and United States patent applications. To the extent that Apex owns or controls foreign counterpart patents or patent applications corresponding to any patent or patent application within the Apex Trocar Patent Family, whether now existing or hereafter acquired or obtained, this Covenant shall extend to such foreign counterpart patents and patent applications in the same manner and to the same extent as it applies to the United States patents and patent applications within the Apex Trocar Patent Family. Apex represents that, as of the Effective Date, it is not aware of any foreign counterpart patents or patent applications within the Apex Trocar Patent Family other than those, if any, identified on Exhibit C to the Settlement Agreement.
SECTION 3 — EXTENSION TO SUBSIDIARIES AND CONTRACT MANUFACTURERS
3.1 Current and Future Subsidiaries. The covenant set forth in Section 2 extends to and for the benefit of all current and future direct and indirect subsidiaries of Solstice Biomedical Devices Ltd. and Solstice Biomedical, Inc., whether now existing or hereafter formed, organized, or acquired during the Term, for so long as such entities remain subsidiaries of either Solstice Parent or Solstice US. For purposes of this Section 3.1, an entity shall be deemed a "subsidiary" of Solstice Parent or Solstice US if Solstice Parent or Solstice US, directly or indirectly, owns or controls more than fifty percent (50%) of the outstanding voting securities or voting equity interests of such entity, or otherwise has the power to direct or cause the direction of the management and policies of such entity, whether through ownership of voting securities, by contract, or otherwise. In the event that an entity ceases to be a subsidiary of either Solstice Parent or Solstice US during the Term (whether by reason of divestiture, sale, spin-off, or otherwise), the benefits of this Covenant shall cease to apply to such entity as of the date on which it ceases to be a subsidiary, and such entity shall thereafter have no further rights or protections under this Covenant.
3.2 Contract Manufacturers. The covenant set forth in Section 2 extends to and for the benefit of contract manufacturers, original equipment manufacturers, and other third-party manufacturers of Covered Products acting under the authority of, on behalf of, and at the direction of any Covenantee Entity, solely to the extent that:
(a) such contract manufacturing activities fall within the Licensed Field;
(b) such contract manufacturing activities are authorized under the sublicense or "have made" rights set forth in the Patent License Agreement (Exhibit A); and
(c) the Covered Products manufactured by such contract manufacturers are manufactured exclusively for sale by or on behalf of the Covenantee Entities.
For the avoidance of doubt, this Covenant does not extend to any contract manufacturer with respect to products manufactured by such contract manufacturer for its own account or for the account of any third party other than a Covenantee Entity. The Solstice Entities shall maintain a current list of authorized contract manufacturers benefiting from this Section 3.2 and shall provide such list to Apex upon reasonable written request, subject to appropriate confidentiality protections.
SECTION 4 — EXCEPTIONS AND LIMITATIONS
4.1 Material Breach Carve-Out. Notwithstanding anything to the contrary in this Covenant, the covenant set forth in Section 2 shall not preclude or prevent Apex from bringing, commencing, or maintaining an action for patent infringement against any Covenantee Entity in the event that any Solstice Entity commits a material breach of the Settlement Agreement or the Patent License Agreement, and such material breach remains uncured after the expiration of the applicable notice and cure period specified in the Settlement Agreement or the Patent License Agreement, as the case may be; provided, however, that Apex shall not bring, commence, or maintain any such action unless and until Apex has first:
(a) provided written notice of the material breach to the breaching Solstice Entity in accordance with the notice provisions of the Settlement Agreement, specifying in reasonable detail the nature of the breach and the actions required to cure such breach;
(b) allowed the applicable cure period (as specified in the Settlement Agreement or the Patent License Agreement, as applicable) to expire without such breach being cured to Apex's reasonable satisfaction; and
(c) terminated the Patent License Agreement in accordance with the termination provisions set forth therein, effective as of the date specified in the notice of termination.
For the avoidance of doubt, a failure by any Solstice Entity to make any payment when due under the Settlement Agreement or the Patent License Agreement shall constitute a material breach for purposes of this Section 4.1 only if such failure continues for a period of more than thirty (30) days following written notice from Apex specifying such failure. The Parties acknowledge that the exercise of Apex's rights under this Section 4.1 is subject to the dispute resolution provisions of the Settlement Agreement, including any mandatory mediation or arbitration provisions contained therein.
4.2 Outside Licensed Field. This Covenant applies solely and exclusively to Covered Products within the Licensed Field (i.e., laparoscopic surgical access devices, as defined in Section 1.5 hereof and in the Patent License Agreement). This Covenant does not extend to, and shall not be construed to cover, any products, devices, systems, components, or activities that fall outside the Licensed Field. Apex expressly retains all rights to enforce any and all patents and patent applications within the Apex Trocar Patent Family against any Covenantee Entity (or any other person or entity) with respect to any products or activities that are outside the Licensed Field, including without limitation products or devices used in open surgery, robotic surgery (other than laparoscopic robotic surgery to the extent included within the Licensed Field as defined in the Patent License Agreement), or any other field of use not encompassed within the Licensed Field. Nothing in this Covenant shall be deemed to constitute a license, covenant not to sue, or other grant of rights with respect to any products or activities outside the Licensed Field.
4.3 Change of Control. In the event of a Change of Control (as defined in the Patent License Agreement) of Solstice Biomedical Devices Ltd. or Solstice Biomedical, Inc., the following provisions shall apply:
(a) This Covenant shall continue to apply to the Covenantee Entities on the same terms and conditions set forth herein, subject to and in accordance with the transferability and assignment provisions of the Patent License Agreement (including any consent requirements set forth therein).
(b) This Covenant shall not extend to the acquiring entity or its affiliates (other than the Covenantee Entities) with respect to any pre-existing products of the acquiring entity that are not Covered Products as defined herein. For the avoidance of doubt, if the acquiring entity or any of its affiliates (other than the Covenantee Entities) manufactures, uses, sells, offers for sale, or imports products that fall within the scope of the Apex Trocar Patent Family but are not Covered Products, this Covenant shall not provide any protection or immunity to the acquiring entity or such affiliates with respect to such products.
(c) The Solstice Entities shall provide written notice to Apex of any Change of Control within fifteen (15) business days of the closing of the transaction giving rise to such Change of Control, in accordance with the notice provisions set forth in Section 9.6 hereof.
4.4 Third-Party Claims. Nothing in this Covenant shall restrict, limit, or otherwise affect Apex's right to assert, enforce, license, or otherwise exercise any of its rights with respect to any patent or patent application within the Apex Trocar Patent Family against any person or entity that is not a Covenantee Entity (as defined herein). Apex retains all rights to bring, commence, initiate, maintain, or prosecute any action, lawsuit, proceeding, complaint, claim, or demand against any third party for infringement of any patent within the Apex Trocar Patent Family, and this Covenant shall not be construed as a waiver, release, or abandonment of any such rights.
SECTION 5 — REPRESENTATIONS AND WARRANTIES OF APEX
Apex hereby represents and warrants to each of the Covenantee Entities as follows:
5.1 Ownership. Apex represents and warrants that, as of the Effective Date, it is the sole and exclusive owner of the entire right, title, and interest in and to each and every patent and patent application within the Apex Trocar Patent Family, including without limitation the '237 Patent, the '884 Patent, and the '105 Patent. All such patents and patent applications are duly and validly assigned to Apex Surgical Innovations, Inc., and all assignments have been duly recorded with the United States Patent and Trademark Office. No other person or entity has any ownership interest, co-ownership interest, or right of any kind in or to any patent or patent application within the Apex Trocar Patent Family, other than the licenses and rights granted under the Patent License Agreement and this Covenant.
5.2 Authority. Apex represents and warrants that it has full corporate power and authority to enter into, execute, and deliver this Covenant Not to Sue and to perform all of its obligations hereunder. The execution, delivery, and performance of this Covenant have been duly authorized by all necessary corporate action on the part of Apex, including any required approvals of the board of directors of Apex. The person executing this Covenant on behalf of Apex is duly authorized to do so.
5.3 No Prior Inconsistent Grants. Apex represents and warrants that, as of the Effective Date, it has not previously granted, assigned, transferred, conveyed, pledged, or encumbered any rights, licenses, immunities, covenants not to sue, or other grants or interests with respect to any patent or patent application within the Apex Trocar Patent Family that would be inconsistent with, contrary to, or that would impair, diminish, or render unenforceable, in whole or in part, the rights, protections, and benefits granted to the Covenantee Entities under this Covenant Not to Sue. Apex further represents and warrants that there are no outstanding agreements, arrangements, or understandings with any third party that would prevent or impair Apex's ability to fully perform its obligations under this Covenant.
5.4 No Encumbrances. Apex represents and warrants that, as of the Effective Date, the patents and patent applications in the Apex Trocar Patent Family are free and clear of any and all liens, mortgages, pledges, security interests, charges, encumbrances, restrictions, or claims of any kind or nature whatsoever (collectively, "Encumbrances") that would impair, diminish, or prevent Apex's ability to grant and perform the covenant set forth herein. In the event that Apex grants any security interest or lien in or to any patent or patent application within the Apex Trocar Patent Family after the Effective Date, Apex shall ensure that such security interest or lien is expressly made subject to and subordinate to the terms and conditions of this Covenant.
SECTION 6 — SUCCESSORS AND ASSIGNS
6.1 Binding on Successors. This Covenant Not to Sue shall be binding upon and shall inure to the benefit of the Parties and their respective successors, assigns, heirs, and legal representatives. Without limiting the generality of the foregoing, any assignee, transferee, or other successor-in-interest to any patent or patent application within the Apex Trocar Patent Family shall take and hold such patent or patent application subject to the terms and conditions of this Covenant Not to Sue. Apex hereby covenants and agrees that, in the event of any assignment, transfer, sale, conveyance, or other disposition (whether voluntary or involuntary, by operation of law or otherwise) of any patent or patent application within the Apex Trocar Patent Family to any third party, Apex shall ensure that:
(a) the instrument of assignment, transfer, or conveyance contains an express written acknowledgment by the assignee, transferee, or successor-in-interest that such assignee, transferee, or successor-in-interest has received a copy of this Covenant and agrees to be bound by and to comply with the terms and conditions of this Covenant to the same extent as Apex; and
(b) Apex provides a fully executed copy of such instrument to the Solstice Entities promptly following execution thereof, and in any event within the time period specified in Section 6.2 below.
Any purported assignment or transfer of any patent or patent application within the Apex Trocar Patent Family that does not comply with the requirements of this Section 6.1 shall not relieve Apex of any of its obligations under this Covenant and shall not impair or diminish the rights and protections of the Covenantee Entities hereunder.
6.2 Notice of Assignment. Apex shall provide written notice to the Solstice Entities within thirty (30) calendar days of any assignment, transfer, sale, conveyance, or other disposition of any patent or patent application within the Apex Trocar Patent Family. Such notice shall identify the patent(s) or patent application(s) assigned or transferred, the identity and contact information of the assignee or transferee, and the effective date of the assignment or transfer. Such notice shall be delivered in accordance with the notice provisions set forth in Section 9.6 hereof.
SECTION 7 — RELATIONSHIP TO SETTLEMENT AGREEMENT AND PATENT LICENSE AGREEMENT
7.1 Integral Part of Settlement. The Parties acknowledge and agree that this Covenant Not to Sue is an integral part of the overall settlement of the Litigation (Case No. 1:24-cv-00587-RGA, Apex Surgical Innovations, Inc. v. Solstice Biomedical, Inc., in the United States District Court for the District of Delaware) and is delivered in connection with and as part of the consideration set forth in the Settlement Agreement. This Covenant is not a standalone agreement but rather a component of a comprehensive settlement that includes the Settlement Agreement, the Patent License Agreement (Exhibit A), and the other Exhibits to the Settlement Agreement. The Parties further acknowledge that this Covenant was a material inducement for the Solstice Entities to enter into the Settlement Agreement and to agree to the financial terms set forth therein.
7.2 Complementary to Patent License Agreement. This Covenant Not to Sue is complementary to, and not in limitation of, the rights and licenses granted under the Patent License Agreement (Exhibit A to the Settlement Agreement). The protections afforded by this Covenant are intended to supplement and reinforce the rights granted under the Patent License Agreement and to provide the Covenantee Entities with the broadest possible protection from patent infringement claims relating to the Apex Trocar Patent Family with respect to Covered Products within the Licensed Field. In the event of any conflict, ambiguity, or inconsistency between the terms of this Covenant Not to Sue and the terms of the Patent License Agreement, the provision that provides the broader protection, immunity, or benefit to the Covenantee Entities shall control with respect to the scope of the covenant and the extent of the protection afforded to the Covenantee Entities.
7.3 Survival. The covenants, agreements, representations, and warranties set forth in this Covenant shall survive the dismissal of the Litigation (Case No. 1:24-cv-00587-RGA) with prejudice pursuant to the Stipulation of Dismissal attached as Exhibit E to the Settlement Agreement, and shall remain in full force and effect for the duration of the Term regardless of such dismissal. The Parties intend that the filing of the Stipulation of Dismissal shall in no way diminish, impair, or affect the enforceability of this Covenant.
SECTION 8 — REMEDIES
8.1 Injunctive Relief. The Parties acknowledge and agree that a breach or threatened breach of this Covenant Not to Sue by Apex would cause irreparable harm to the Covenantee Entities for which monetary damages would be an inadequate remedy. Accordingly, in the event of a breach or threatened breach of this Covenant Not to Sue by Apex (or by any successor or assign of Apex), any Covenantee Entity shall be entitled to seek and obtain specific performance and injunctive relief (including temporary restraining orders, preliminary injunctions, and permanent injunctions) in any court of competent jurisdiction, in addition to and not in limitation of any other remedies available at law or in equity. Such injunctive relief may be sought without the necessity of proving actual damages or irreparable harm (which shall be presumed) and without the requirement of posting a bond or other security (or, if a bond or security is required by applicable law, such bond or security shall be in the minimum amount permitted by law).
8.2 Attorneys' Fees. In any action, suit, or proceeding brought to enforce the terms of this Covenant Not to Sue, or to obtain damages or other relief for any breach or threatened breach hereof, the prevailing party (as determined by the court) shall be entitled to recover from the non-prevailing party its reasonable attorneys' fees, expert witness fees, court costs, and other litigation expenses incurred in connection with such action, suit, or proceeding, including any appeal thereof.
SECTION 9 — GENERAL PROVISIONS
9.1 Governing Law. This Covenant Not to Sue shall be governed by, construed in accordance with, and enforced under the laws of the State of Delaware, without giving effect to any choice-of-law or conflict-of-laws rules, principles, or provisions (whether of the State of Delaware or any other jurisdiction) that would cause the application of the laws of any jurisdiction other than the State of Delaware. Notwithstanding the foregoing, all questions relating to the validity, enforceability, construction, and infringement of United States patents shall be governed by and construed in accordance with the patent laws of the United States (Title 35 of the United States Code).
9.2 Jurisdiction and Venue. Any dispute, controversy, claim, or cause of action arising out of, relating to, or in connection with this Covenant Not to Sue, including any question regarding the existence, validity, interpretation, performance, breach, or termination of this Covenant, shall be subject to the exclusive jurisdiction of the United States District Court for the District of Delaware. In the event that such court lacks subject-matter jurisdiction, jurisdiction shall lie exclusively in the courts of the State of Delaware sitting in Wilmington, New Castle County, Delaware. Each Party hereby irrevocably and unconditionally (a) consents and submits to the personal jurisdiction of such courts, (b) waives any objection that it may now or hereafter have to the laying of venue in such courts, and (c) waives any claim or defense of inconvenient forum with respect to any action, suit, or proceeding brought in such courts.
9.3 Entire Agreement. This Covenant Not to Sue, together with the Settlement Agreement, the Patent License Agreement (Exhibit A to the Settlement Agreement), and the other Exhibits thereto, constitutes the entire agreement of the Parties with respect to the subject matter hereof and supersedes all prior and contemporaneous negotiations, discussions, proposals, agreements, representations, warranties, and understandings of the Parties, whether written or oral, relating to the subject matter hereof. No Party has relied on any statement, representation, warranty, or agreement of any other Party except as expressly set forth herein or in the Settlement Agreement and the Patent License Agreement. The Term Sheet dated June 10, 2025 is superseded in its entirety by the Settlement Agreement, the Patent License Agreement, and this Covenant, and shall have no further force or effect.
9.4 Amendment. This Covenant Not to Sue may not be amended, modified, supplemented, or waived except by a written instrument that (a) expressly refers to this Covenant Not to Sue, (b) sets forth the specific provision(s) being amended, modified, supplemented, or waived, and (c) is duly executed by an authorized representative of each Party hereto. No oral agreement or course of dealing shall be effective to amend, modify, or waive any provision of this Covenant.
9.5 Severability. If any provision of this Covenant Not to Sue, or the application of any provision to any person, entity, or circumstance, is held by a court of competent jurisdiction to be invalid, illegal, void, or unenforceable in any respect, such invalidity, illegality, or unenforceability shall not affect any other provision hereof or the application of such provision to any other person, entity, or circumstance, and the remaining provisions of this Covenant shall remain in full force and effect and shall be construed and enforced as if such invalid, illegal, or unenforceable provision had not been included herein. The Parties shall use commercially reasonable efforts to negotiate and agree upon a valid, legal, and enforceable substitute provision that most nearly achieves the intent and economic effect of the invalid, illegal, or unenforceable provision.
9.6 Notices. All notices, requests, demands, consents, approvals, and other communications required or permitted to be given under this Covenant Not to Sue shall be in writing and shall be deemed duly given and effective upon delivery if delivered in accordance with the notice provisions of the Settlement Agreement. Without limiting the generality of the foregoing, notices shall be addressed as follows:
If to Apex:
Apex Surgical Innovations, Inc. 1220 North Market Street, Suite 550 Wilmington, Delaware 19801
Attention: Martin Hale, General Counsel
Email: mhale@apexsurgical.com
With a copy (which shall not constitute notice) to:
Victoria Stanton, Esq. Hargrove, Tate & Bennington LLP 900 North King Street, Suite 1200 Wilmington, Delaware 19801
Email: vstanton@htblaw.com
If to Solstice Biomedical Devices Ltd.:
Solstice Biomedical Devices Ltd. Unit 14, Clonskeagh Business Park Clonskeagh Road, Dublin 14 D14 YF28, Ireland
Attention: Eamon Rourke, General Counsel
Email: erourke@solsticebiomedical.com
With a copy (which shall not constitute notice) to:
Marcus Delgado, Esq. Calderwood & Harkness LLP 1201 Market Street, Suite 2500 Wilmington, Delaware 19801
Email: mdelgado@calderwoodharkness.com
If to Solstice Biomedical, Inc.:
Solstice Biomedical, Inc. 3800 Concord Pike, Suite 410 Wilmington, Delaware 19803
Attention: General Counsel
Email: legal@solsticebiomedical.com
Any Party may change its address for notices by giving written notice of such change to the other Parties in accordance with this Section 9.6.
9.7 Counterparts. This Covenant Not to Sue may be executed in any number of counterparts, each of which shall be deemed an original and all of which, taken together, shall constitute one and the same instrument. Delivery of an executed counterpart of this Covenant by facsimile transmission, by electronic mail in portable document format (.pdf), or by any other electronic means intended to preserve the original graphic and pictorial appearance of a document shall have the same effect as delivery of an originally executed counterpart. Electronic signatures (including signatures transmitted via Brightwater Software, Ashford Health IT, or similar electronic signature platforms) shall be deemed valid and binding for all purposes and shall have the same legal effect as original ink signatures.
9.8 No Third-Party Beneficiaries. Except as expressly provided in Section 3 hereof with respect to subsidiaries and contract manufacturers of the Covenantee Entities, this Covenant Not to Sue is intended solely for the benefit of the Parties hereto and their respective successors and permitted assigns, and does not confer any rights, remedies, obligations, or causes of action upon any person or entity other than the Parties hereto and their respective successors and permitted assigns. No person or entity that is not a Party to this Covenant shall have standing to enforce any provision of this Covenant or to assert any claim arising out of or in connection with this Covenant.
9.9 Waiver. No failure or delay by any Party in exercising any right, power, or privilege under this Covenant Not to Sue shall operate as a waiver thereof, nor shall any single or partial exercise of any such right, power, or privilege preclude any other or further exercise thereof or the exercise of any other right, power, or privilege. All rights and remedies provided in this Covenant are cumulative and are not exclusive of any other rights or remedies provided by law, in equity, or otherwise.
[SIGNATURE PAGE FOLLOWS]
IN WITNESS WHEREOF, the Parties have caused this Covenant Not to Sue to be executed by their respective duly authorized representatives as of the date first written above.
APEX SURGICAL INNOVATIONS, INC. (Covenantor)
By: ________
Name: Gerald K. Whitford
Title: Chief Executive Officer
Date: June 16, 2025
SOLSTICE BIOMEDICAL DEVICES LTD. (Covenantee)
By: ________
Name: Dr. Fiona Tierney
Title: Chief Executive Officer
Date: June 16, 2025
SOLSTICE BIOMEDICAL, INC. (Covenantee)
By: ________
Name: Eamon Rourke
Title: General Counsel (Authorized Signatory)
Date: June 16, 2025
ACKNOWLEDGED BY COUNSEL:
For Apex Surgical Innovations, Inc.:
________________________________________
Victoria Stanton, Esq. Hargrove, Tate & Bennington LLP 900 North King Street, Suite 1200 Wilmington, Delaware 19801
For Solstice Biomedical Devices Ltd. and Solstice Biomedical, Inc.:
________________________________________
Marcus Delgado, Esq. Calderwood & Harkness LLP 1201 Market Street, Suite 2500 Wilmington, Delaware 19801
CONFIDENTIAL — This Exhibit B constitutes a confidential settlement document subject to the confidentiality provisions of the Settlement Agreement and Mutual Release dated June 16, 2025.

EXHIBIT B

COVENANT NOT TO SUE

RECITALS

WHEREAS:

ACKNOWLEDGED BY COUNSEL:

Record

Parties

Dates

Amounts