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UNDERWRITING AGREEMENT

(Execution Version)

March 2, 2023

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UNDERWRITING AGREEMENT

March 2, 2023

Keystone Mercer & Co., LLC 280 Park Avenue, 14th Floor New York, NY 10017

As Representative of the Several Underwriters Named in Schedule I Hereto

Ladies and Gentlemen:

Solstice Biomedical Devices Limited, a private company limited by shares incorporated under the laws of Ireland (Companies Registration Office Number 587412), with its registered office at Unit 7, Lakeview Technology Campus, Parkmore East, Galway, H91 XK72, Ireland (the "Company"), proposes to issue and sell to the several underwriters named in Schedule I hereto (collectively, the "Underwriters"), for whom Keystone Mercer & Co., LLC is acting as representative (the "Representative"), American Depositary Shares ("ADSs"), each representing one (1) ordinary share, nominal value €0.01 per share, of the Company (the "Ordinary Shares"), on the terms and conditions set forth in this Underwriting Agreement (this "Agreement").

The ADSs are to be issued pursuant to the Deposit Agreement dated as of March 2, 2023 (the "Deposit Agreement"), among the Company, Meridian Trust Company, N.A., as depositary (the "Depositary"), and all holders and beneficial owners of ADSs issued thereunder. The ADSs have been assigned CUSIP Number 83472R 109 and have been approved for listing on the Nasdaq Global Market under the ticker symbol "SBDX," subject only to official notice of issuance.

The Company has filed with the Securities and Exchange Commission (the "Commission" or the "SEC") a registration statement on Form S-1 (File No. 333-268514), including a prospectus, relating to the ADSs to be sold hereunder. Such registration statement was declared effective by the Commission on February 28, 2023. The Company initially submitted a Confidential Draft Registration Statement to the Commission on November 14, 2022, and thereafter filed a first amendment on January 18, 2023, in response to the Commission's first-round comment letter dated December 22, 2022, and a second amendment on February 17, 2023, in response to the Commission's second-round comment letter dated February 8, 2023. As used in this Agreement:

(a) "Registration Statement" means the registration statement on Form S-1 (File No. 333-268514), as amended at the time it became effective and as thereafter amended by any post-effective amendments thereto, including all exhibits, financial statements, and schedules thereto and all documents incorporated by reference therein, and including any information deemed to be a part thereof pursuant to Rule 430A under the Securities Act of 1933, as amended (the "Act");

(b) "Prospectus" means the final prospectus relating to the ADSs dated March 2, 2023, as filed with the Commission pursuant to Rule 424(b) of the rules and regulations of the Commission under the Act (the "Rules and Regulations"), including all documents incorporated by reference therein;

(c) "Preliminary Prospectus" means any preliminary prospectus relating to the ADSs included in the Registration Statement or filed with the Commission pursuant to Rule 424(a) of the Rules and Regulations;

(d) "Time of Sale Information" means the information included in the Preliminary Prospectus dated February 28, 2023, together with the information set forth on Schedule III hereto (if any) and each Free Writing Prospectus (as defined below) issued at or prior to the Applicable Time, taken together;

(e) "Free Writing Prospectus" means each "free writing prospectus" (as defined in Rule 405 under the Act) relating to the ADSs that is required to be filed with the Commission by the Company or any Underwriter;

(f) "Applicable Time" means the time of pricing on March 2, 2023; and

(g) "Exchange Act" means the Securities Exchange Act of 1934, as amended, and the rules and regulations of the Commission thereunder.

All references in this Agreement to the Registration Statement, any Preliminary Prospectus, the Prospectus, or any Free Writing Prospectus, or any amendment or supplement to any of the foregoing, shall be deemed to include any copy filed with the Commission pursuant to the Electronic Data Gathering, Analysis and Retrieval System ("EDGAR").

All references in this Agreement to financial statements and schedules and other information that is "contained," "included," or "stated" in the Registration Statement, any Preliminary Prospectus, or the Prospectus (or other references of like import) shall be deemed to include all such financial statements and schedules and other information that is incorporated by reference in the Registration Statement, any Preliminary Prospectus, or the Prospectus, as the case may be.

SECTION 1. SALE AND PURCHASE OF ADSs.

1(a). Firm ADSs.

Upon the basis of the representations, warranties, and agreements of the Company herein contained, and subject to the terms and conditions set forth herein, the Company agrees to issue and sell to the several Underwriters, and each of the Underwriters agrees, severally and not jointly, to purchase from the Company, the number of ADSs (the "Firm ADSs") set forth opposite the name of such Underwriter in Schedule I hereto, at a purchase price of $10.3569 per ADS (which is equal to the public offering price of $11.0769 per ADS (the "Public Offering Price"), less the underwriting discount of $0.71999985 per ADS, representing 6.5% of the Public Offering Price). The total number of Firm ADSs to be sold by the Company and purchased by the several Underwriters hereunder shall be 6,666,667 ADSs. The aggregate underwriting discount on the Firm ADSs shall be approximately $4,800,000, representing 6.5% of the aggregate Public Offering Price of the Firm ADSs.

1(b). Option ADSs (Overallotment).

In addition, the Company hereby grants to the several Underwriters an option (the "Overallotment Option") to purchase, severally and not jointly, up to an additional 1,000,000 ADSs (the "Option ADSs" and, together with the Firm ADSs, the "ADSs") at the same purchase price per ADS as set forth in Section 1(a) above (i.e., $10.3569 per ADS), less an amount per ADS equal to any dividends or distributions declared by the Company and payable on the Firm ADSs but not payable on the Option ADSs. The Overallotment Option may be exercised in whole or in part at any time and from time to time on or before the thirtieth (30th) day after the date of the Prospectus (i.e., exercisable through and including April 1, 2023). The Overallotment Option shall be exercisable solely for the purpose of covering over-allotments, if any, made in connection with the offering of the Firm ADSs.

Upon full exercise of the Overallotment Option, the total number of ADSs to be sold by the Company and purchased by the several Underwriters hereunder shall be 7,666,667 ADSs. Upon full exercise, the aggregate gross proceeds to the Company from the offering shall be approximately $85,000,000 (being 7,666,667 ADSs multiplied by the Public Offering Price of $11.0769, rounded to the nearest thousand). The total underwriting discount upon full exercise of the Overallotment Option shall be approximately $5,525,000 (representing 6.5% of the aggregate gross proceeds of approximately $85,000,000). The net proceeds to the Company, before deduction of estimated offering expenses of approximately $3,200,000, upon full exercise of the Overallotment Option shall be approximately $79,475,000.

If the Overallotment Option is exercised, each Underwriter shall purchase the number of Option ADSs that bears the same proportion to the total number of Option ADSs to be purchased as the number of Firm ADSs set forth opposite the name of such Underwriter in Schedule I bears to the total number of Firm ADSs, subject to such adjustments as the Representative may determine to avoid fractional ADSs.

1(c). Payment and Delivery — Firm ADSs.

Payment for and delivery of the Firm ADSs shall be made at the offices of Calderwood & Harkness LLP, 425 Lexington Avenue, New York, NY 10174 (or such other location as the Representative and the Company may agree upon in writing), at 10:00 a.m. (New York City time) on March 21, 2023 (the "Closing Date"), or at such other date as the Representative and the Company may agree upon in writing; provided, however, that the Closing Date shall not be later than five (5) business days after the originally scheduled Closing Date without the written consent of the Representative. For the avoidance of doubt, the originally expected closing date was March 7, 2023; the actual Closing Date of March 21, 2023 has been agreed to by the Representative and the Company in order to accommodate ADS settlement mechanics and the deposit of underlying Ordinary Shares with the Depositary.

On the Closing Date, the Company shall deliver or cause to be delivered the Firm ADSs to the account of the Representative through the facilities of The Depository Trust Company ("DTC") for the accounts of the several Underwriters, against payment of the aggregate purchase price therefor by wire transfer of immediately available funds to the Company's designated account maintained by Northvale Fiduciary Services LLC, as escrow agent, located at 1 Liberty Plaza, Suite 4200, New York, NY 10006 (Attention: Angela Morse, Director) (the "Escrow Agent"), for prompt release to the Company upon satisfaction of the conditions set forth in the escrow letter agreement between the Company, the Representative, and the Escrow Agent. The Firm ADSs so to be delivered are to be made available for checking by the Representative at the offices of DTC or its designated custodian not later than 1:00 p.m. (New York City time) on the business day preceding the Closing Date.

1(d). Payment and Delivery — Option ADSs.

The Overallotment Option shall be exercisable by delivery by the Representative of written notice (or notice by facsimile or electronic mail confirmed in writing) to the Company setting forth the number of Option ADSs to be purchased and the date and time for such delivery and payment (each, an "Option Closing Date"). Each Option Closing Date shall be determined by the Representative but shall not be earlier than the Closing Date nor earlier than the second (2nd) business day after the date on which the Overallotment Option shall have been exercised. Payment for and delivery of the Option ADSs shall be made at the same location and in the same manner as set forth in Section 1(c) above with respect to the Firm ADSs, mutatis mutandis.

SECTION 2. REPRESENTATIONS AND WARRANTIES OF THE COMPANY.

The Company represents and warrants to, and agrees with, each of the Underwriters that, as of the date hereof, the Closing Date, and each Option Closing Date (if any):

2(a). Registration Statement and Prospectus.

The Registration Statement on Form S-1 (File No. 333-268514) has been prepared by the Company in conformity with the requirements of the Act and the Rules and Regulations and was filed with the Commission. The Registration Statement was declared effective by the Commission on February 28, 2023. The Confidential Draft Registration Statement was initially submitted to the Commission on November 14, 2022 pursuant to the Jumpstart Our Business Startups Act of 2012 (the "JOBS Act"). A first amendment to the Confidential Draft Registration Statement was filed with the Commission on January 18, 2023, in response to the Commission's first-round comment letter dated December 22, 2022. A second amendment was filed with the Commission on February 17, 2023, in response to the Commission's second-round comment letter dated February 8, 2023. The Commission has not issued any further comments with respect to the Registration Statement that remain outstanding as of the date hereof.

The Registration Statement, including the Prospectus and all amendments and supplements thereto, at the time the Registration Statement became effective and at each subsequent amendment thereto, complied and will comply in all material respects with the requirements of the Act and the Rules and Regulations. The Prospectus, as of the date thereof and as of the Closing Date (and each Option Closing Date, if any), complied and will comply in all material respects with the requirements of the Act and the Rules and Regulations.

No stop order suspending the effectiveness of the Registration Statement has been issued by the Commission, and no proceeding for that purpose has been initiated or, to the knowledge of the Company, threatened by the Commission. No order preventing or suspending the use of any Preliminary Prospectus or the Prospectus has been issued by the Commission, and no proceeding for that purpose has been initiated or, to the knowledge of the Company, threatened by the Commission.

The Registration Statement, at the time it became effective and as of the date hereof, did not and does not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order to make the statements therein not misleading. The Prospectus, as of its date and as of the Closing Date (and each Option Closing Date, if any), did not and will not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading. The Time of Sale Information, at the Applicable Time, did not contain any untrue statement of a material fact or omit to state a material fact necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading. The preceding two sentences do not apply to statements in or omissions from the Registration Statement, the Prospectus, or the Time of Sale Information made in reliance upon and in conformity with written information furnished to the Company by any Underwriter through the Representative expressly for use therein.

Each Preliminary Prospectus filed as part of the Registration Statement or filed pursuant to Rule 424 under the Act complied when so filed in all material respects with the requirements of the Act and the Rules and Regulations. Each Free Writing Prospectus, if any, that the Company is required to file pursuant to Rule 433(d) under the Act has been, or will be, filed with the Commission in accordance with the requirements of the Act and the Rules and Regulations. Each Free Writing Prospectus, as of its issue date and at all subsequent times through the completion of the public offering and sale of the ADSs or until any earlier date on which the Company notified or notifies the Representative that such Free Writing Prospectus is no longer being used in connection with the offering, did not, does not, and will not include any information that conflicts with the information contained in the Registration Statement or the Prospectus.

2(b). Organization and Good Standing.

The Company is a private company limited by shares duly incorporated and validly existing under the laws of Ireland, registered with the Companies Registration Office of Ireland under Number 587412. The Company has full corporate power and authority to own, lease, and operate its properties and to conduct its business as described in the Prospectus and to enter into and perform its obligations under this Agreement. The Company is duly qualified to do business and is in good standing (or the equivalent thereof under the laws of the applicable jurisdiction) in each jurisdiction in which the character of the business conducted by it or the nature or location of the properties owned or leased by it requires such qualification, except where the failure to be so qualified or in good standing would not, individually or in the aggregate, have a Material Adverse Effect (as defined below).

As used herein, "Material Adverse Effect" means (i) a material adverse change in, or material adverse effect upon, the business, properties, assets, liabilities, operations, financial condition, or results of operations of the Company and its subsidiaries, taken as a whole, (ii) a material impairment of the ability of the Company to perform its obligations under this Agreement, the Deposit Agreement, or the Registration Rights Agreement (as defined below), or (iii) a material impairment of the legality, validity, or enforceability of this Agreement, the Deposit Agreement, or the Registration Rights Agreement.

Solstice Surgical Inc. is a corporation duly incorporated and validly existing under the laws of the State of Delaware (Employer Identification Number 87-4231568), with its principal office at 200 West Adams Street, Suite 1100, Chicago, IL 60606 (the "U.S. Subsidiary"). The U.S. Subsidiary is a wholly owned subsidiary of the Company and is duly qualified to do business and is in good standing in each jurisdiction in which the character of the business conducted by it or the nature or location of the properties owned or leased by it requires such qualification, except where the failure to be so qualified or in good standing would not, individually or in the aggregate, have a Material Adverse Effect. The U.S. Subsidiary has full corporate power and authority to own, lease, and operate its properties and to conduct its business as described in the Prospectus. Except for the U.S. Subsidiary, the Company does not have any other subsidiaries.

2(c). Capitalization. The authorized share capital of the Company consists of 100,000,000 Ordinary Shares, nominal value €0.01 per share, as amended by shareholder resolution in connection with the transactions contemplated by this Agreement. As of the date hereof, prior to giving effect to the sale of the ADSs contemplated hereby, 28,000,000 Ordinary Shares are issued and outstanding. Immediately after giving effect to the sale of the Firm ADSs contemplated hereby, 34,666,667 Ordinary Shares will be issued and outstanding. Immediately after giving effect to the sale of the Firm ADSs and the full exercise of the Overallotment Option, 35,666,667 Ordinary Shares will be issued and outstanding. All of the outstanding Ordinary Shares have been duly authorized and validly issued and are fully paid and non-assessable (within the meaning of the Irish Companies Act 2014) and were not issued in violation of any preemptive or similar rights.

The Ordinary Shares underlying the ADSs to be issued and sold by the Company hereunder have been duly authorized by all necessary corporate action on the part of the Company and, when issued and delivered to the Depositary (or its custodian) against payment therefor as provided herein, will be validly issued, fully paid, and non-assessable (within the meaning of the Irish Companies Act 2014) and will not have been issued in violation of any preemptive or similar rights.

No preemptive rights or other similar rights of shareholders exist with respect to any of the Ordinary Shares or the ADSs. Except as set forth in the Prospectus, there are no outstanding options, warrants, or other rights to purchase, or any outstanding securities convertible into or exchangeable for, any Ordinary Shares or ADSs of the Company. The description of the Company's authorized and outstanding share capital set forth in the Prospectus under the caption "Description of Share Capital" is accurate in all material respects as of the dates indicated therein.

2(d). Authorization. The Company has full corporate power and authority to execute, deliver, and perform its obligations under this Agreement, the Deposit Agreement, and the Registration Rights Agreement dated as of March 2, 2023 among the Company, Greystone Ventures Fund III, L.P., Pinnacle Health Innovation Fund, L.P., and Elkridge Growth Partners II, L.P. (the "Registration Rights Agreement"). The execution and delivery of this Agreement by the Company, the consummation by the Company of the transactions contemplated hereby, and the performance by the Company of its obligations hereunder have been duly authorized by all necessary corporate action on the part of the Company, including resolutions of the board of directors of the Company and resolutions of the shareholders of the Company (including, without limitation, the shareholder resolution amending the authorized share capital of the Company to 100,000,000 Ordinary Shares, nominal value €0.01 per share, and the shareholder resolution authorizing the initial public offering of ADSs and the execution and delivery of this Agreement and the other Transaction Documents (as defined below)). This Agreement has been duly executed and delivered by the Company and, assuming the due authorization, execution, and delivery hereof by the Representative, constitutes a legal, valid, and binding obligation of the Company, enforceable against the Company in accordance with its terms, except as may be limited by (i) bankruptcy, insolvency, reorganization, moratorium, examinership, or similar laws relating to or affecting the enforcement of creditors' rights generally, and (ii) general equitable principles (whether such enforceability is considered in a proceeding in equity or at law).

As used herein, "Transaction Documents" means this Agreement, the Deposit Agreement, the Registration Rights Agreement, and each Lock-Up Agreement (as defined below).

2(e). No Conflicts.

The execution, delivery, and performance of this Agreement and each of the other Transaction Documents by the Company, the issuance and sale of the ADSs (and the underlying Ordinary Shares), and the consummation of the transactions contemplated hereby and thereby will not (i) violate, conflict with, or result in a breach of any provision of the memorandum and articles of association of the Company (as amended and currently in effect) or the certificate of incorporation, bylaws, or other organizational documents of the U.S. Subsidiary, (ii) violate or result in a breach of any applicable law, statute, rule, regulation, judgment, order, writ, or decree of any governmental authority having jurisdiction over the Company, the U.S. Subsidiary, or any of their respective properties or assets, (iii) result in a breach of, or constitute a default (or an event that, with the giving of notice or lapse of time, or both, would constitute a default) under, or give rise to any right of termination, amendment, acceleration, or cancellation of, any material agreement, mortgage, deed of trust, indenture, note, bond, license, lease agreement, or other instrument or obligation to which the Company or the U.S. Subsidiary is a party or by which any of them or any of their respective properties or assets are bound, or (iv) result in the creation or imposition of any lien, charge, claim, security interest, encumbrance, right of first refusal, or other restriction of any kind on any property or asset of the Company or the U.S. Subsidiary.

2(f). No Consents Required.

No consent, approval, authorization, order, license, registration, or qualification of or with any court, governmental authority, or body, or any regulatory or self-regulatory organization, is required in connection with the execution, delivery, and performance of this Agreement by the Company, the issuance and sale of the ADSs (and the underlying Ordinary Shares), or the consummation of the transactions contemplated hereby, except (i) such as have already been obtained or made, including the effectiveness of the Registration Statement under the Act, the approval of the listing of the ADSs on the Nasdaq Global Market, and the receipt of the no-objection letter from the Financial Industry Regulatory Authority, Inc. ("FINRA"), and (ii) such as may be required under state securities or "blue sky" laws in connection with the purchase and distribution of the ADSs by the Underwriters and the qualification of the ADSs for listing on the Nasdaq Global Market, which filings and registrations will be effected in accordance with Section 5(c) of this Agreement.

2(g). Financial Statements.

The audited consolidated financial statements of the Company for the fiscal years ended December 31, 2020 ("FY2020"), December 31, 2021 ("FY2021"), and December 31, 2022 ("FY2022"), included in the Registration Statement and the Prospectus, together with the related notes thereto and the independent auditor's reports thereon of Calderwood & Associates LLP (PCAOB ID No. 4518; engagement partner: Patricia Yuen, CPA), have been prepared in conformity with International Financial Reporting Standards as issued by the International Accounting Standards Board ("IFRS") applied on a consistent basis throughout the periods involved (except as may be noted therein or in the notes thereto), and fairly present in all material respects the financial position of the Company as of the dates thereof and the results of operations and cash flows for the periods then ended.

The key financial metrics for FY2022, as reflected in the financial statements included in the Prospectus, are as follows:

The selected financial data and the summary financial information included in the Registration Statement and the Prospectus present fairly in all material respects the information shown therein and have been compiled on a basis consistent with that of the audited financial statements of the Company included in the Registration Statement and the Prospectus. The pro forma financial information, if any, included in the Registration Statement and the Prospectus has been properly compiled and prepared in accordance with the applicable requirements of the Act and the Rules and Regulations and the assumptions underlying such pro forma financial information are reasonable and are set forth in the Registration Statement and the Prospectus.

Calderwood & Associates LLP, which has audited the financial statements included in the Prospectus and delivered its reports with respect thereto, is a registered public accounting firm as required by the Act and the Rules and Regulations and the rules of the Public Company Accounting Oversight Board.

2(h). No Material Adverse Change.

Since December 31, 2022, the date of the most recent balance sheet included in the Registration Statement and the Prospectus, (i) there has been no Material Adverse Effect on the business, properties, assets, liabilities, operations, financial condition, results of operations, or prospects of the Company and its subsidiaries, taken as a whole, whether or not arising from transactions in the ordinary course of business, except as set forth in or contemplated by the Prospectus, (ii) the Company and its subsidiaries, taken as a whole, have not incurred any material liability or obligation, direct or contingent, other than in the ordinary course of business, (iii) the Company has not declared or paid any dividend or made any other distribution on or in respect of its Ordinary Shares, and (iv) there has been no change in the share capital or long-term debt of the Company or any of its subsidiaries, or any grants or issuances of stock options, restricted shares, or other equity-based awards by the Company, except in each case as described in or contemplated by the Prospectus.

2(i). Intellectual Property.

The Company and its subsidiaries own or have adequate rights to use all patents, patent applications, trademarks, trademark applications, service marks, trade names, trade secrets, copyrights, licenses, domain names, information, technology, know-how, and other intellectual property (collectively, "intellectual Property") material to the conduct of the business of the Company and its subsidiaries as described in the Prospectus, free and clear of all liens, encumbrances, defects, or other restrictions, except as would not, individually or in the aggregate, have a Material Adverse Effect. The Company's material registered intellectual Property includes, without limitation, the trademarks NeuroPath™ and OrthoSync™, as well as the patent portfolio described in the Prospectus under the caption "Business — Intellectual Property."

To the Company's knowledge, neither the Company nor any of its subsidiaries is infringing, misappropriating, or otherwise violating the intellectual Property rights of any third party. No claim, action, suit, investigation, or proceeding relating to the intellectual Property of the Company or its subsidiaries, including any claim of infringement, misappropriation, or violation by or against the Company or any of its subsidiaries, has been instituted, is pending, or, to the Company's knowledge, has been threatened, in writing or otherwise, by or against the Company or any of its subsidiaries.

2(j). Regulatory Compliance.

The Company and its subsidiaries hold all material permits, licenses, approvals, clearances, registrations, exemptions, and authorizations from governmental and regulatory authorities (collectively, "Permits") necessary for the conduct of the business of the Company and its subsidiaries as described in the Prospectus. Such Permits are valid and in full force and effect, and the Company and its subsidiaries are in compliance with the terms and conditions of all such Permits in all material respects.

Without limiting the generality of the foregoing:

(i) The NeuroPath™ Guided Navigation System received clearance from the U.S. Food and Drug Administration (the "FDA") pursuant to a premarket notification under Section 510(k) of the Federal Food, Drug, and Cosmetic Act, as amended (the "FD&C Act"), bearing submission number K211847, with clearance granted on June 14, 2021. The NeuroPath™ Guided Navigation System also holds a valid CE Mark under the Medical Devices Directive (93/42/EEC) / Medical Device Regulation (EU) 2017/745 transition provisions, with such CE Mark valid through May 2025.

(ii) The OrthoSync™ Intraoperative Imaging Platform is the subject of an Investigational Device Exemption ("IDE") bearing number G220035, which was approved by the FDA on September 2, 2022. A pivotal clinical trial pursuant to such IDE is currently being conducted at six (6) clinical trial sites in the United States. The Company is in compliance in all material respects with the terms and conditions of the approved IDE, including applicable requirements of 21 C.F.R. Part 812.

(iii) The Company and its subsidiaries are in compliance in all material respects with all applicable healthcare and regulatory laws, including the FD&C Act, the regulations promulgated thereunder, the EU Medical Device Regulation, and all other applicable laws and regulations relating to the design, development, testing, manufacturing, labeling, marketing, distribution, import, export, and commercialization of the Company's products.

Neither the Company nor any of its subsidiaries has received any written notice from the FDA, any other U.S. or foreign governmental authority, or any institutional review board alleging or asserting material noncompliance with the FD&C Act, the IDE regulations, or any other applicable law, regulation, or Permit. There are no pending or, to the Company's knowledge, threatened claims, suits, proceedings, hearings, investigations, charges, complaints, demands, or injunctions against the Company or any of its subsidiaries relating to any regulatory matter that would, individually or in the aggregate, have a Material Adverse Effect.

2(k). Tax Matters.

The Company and each of its subsidiaries have filed all material federal, state, local, and foreign tax returns required to be filed by them and have paid all taxes required to have been paid by them and any assessments received by them, except for any taxes or assessments the amount, applicability, or validity of which is currently being contested in good faith and for which appropriate reserves have been established in accordance with IFRS. There are no material tax deficiencies that have been asserted or assessed (or, to the Company's knowledge, proposed to be assessed) against the Company or any of its subsidiaries.

Based on the projected revenue composition of the Company for the fiscal year ending December 31, 2023 (with more than 75% of the Company's gross income expected to constitute active trade or business income), the Company does not expect to be classified as a "passive foreign investment company" ("PFIC") within the meaning of Section 1297 of the U.S. Internal Revenue Code of 1986, as amended (the "Code"), for U.S. federal income tax purposes for the taxable year ending December 31, 2023. The Company will use commercially reasonable efforts to avoid PFIC status in future taxable years.

The Company's U.S. Subsidiary, Solstice Surgical Inc., maintains a cost-plus intercompany services agreement with the Company pursuant to which the U.S. Subsidiary provides certain administrative, regulatory, and clinical support services to the Company in exchange for reimbursement of the U.S. Subsidiary's costs plus a 7.5% markup. Such intercompany services agreement has been prepared and is maintained in compliance with applicable transfer pricing rules, including Section 482 of the Code and the Treasury Regulations promulgated thereunder, and the OECD Transfer Pricing Guidelines for Multinational Enterprises and Tax Administrations.

For the avoidance of doubt, the standard rate of Irish withholding tax on dividends is 25%. However, under the Convention Between the Government of the United States of America and the Government of Ireland for the Avoidance of Double Taxation and the Prevention of Fiscal Evasion with Respect to Taxes on Income and Capital Gains (the "U.S.–Ireland Double Taxation Convention"), the rate of withholding tax on dividends paid by the Company to qualifying U.S. holders is reduced to 15%.

2(l). Deposit Agreement.

The Deposit Agreement, dated as of March 2, 2023, among the Company, Meridian Trust Company, N.A. (having its principal corporate trust office at 500 Ross Street, Pittsburgh, PA 15219; Attention: Thomas Crenna, Vice President, Depositary Receipts), as Depositary, and all holders and beneficial owners of ADSs issued thereunder, has been duly authorized by all necessary corporate action on the part of the Company and has been duly executed and delivered by the Company. The Deposit Agreement constitutes a legal, valid, and binding obligation of the Company, enforceable against the Company in accordance with its terms, except as may be limited by (i) bankruptcy, insolvency, reorganization, moratorium, examinership, or similar laws relating to or affecting the enforcement of creditors' rights generally, and (ii) general equitable principles (whether such enforceability is considered in a proceeding in equity or at law). Each ADS issued pursuant to the Deposit Agreement represents one (1) Ordinary Share, and the rights of holders and beneficial owners of ADSs are as set forth in the Deposit Agreement.

2(m). Internal Controls and Disclosure Controls.

The Company maintains a system of internal accounting controls sufficient to provide reasonable assurance that (i) transactions are executed in accordance with management's general or specific authorization, (ii) transactions are recorded as necessary to permit preparation of financial statements in conformity with IFRS and to maintain accountability for assets, (iii) access to assets is permitted only in accordance with management's general or specific authorization, and (iv) the recorded accountability for assets is compared with existing assets at reasonable intervals and appropriate action is taken with respect to any differences. The Company's internal control over financial reporting is effective and the Company is not aware of any material weaknesses in its internal control over financial reporting.

The Company has established and maintains disclosure controls and procedures (as such term is defined in Rule 13a-15(e) under the Exchange Act) that are designed to ensure that information required to be disclosed by the Company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized, and reported, within the time periods specified in the Commission's rules and forms, and is accumulated and communicated to the Company's management, including its principal executive officer and principal financial officer, as appropriate, to allow timely decisions regarding required disclosure.

2(n). Insurance. The Company and its subsidiaries maintain insurance covering their respective properties, operations, personnel, and businesses, including business interruption insurance, in amounts and with deductibles and self-insured retentions that the Company believes are reasonable and adequate for the conduct of the business of the Company and its subsidiaries as described in the Prospectus.

Without limiting the foregoing, the Company maintains directors' and officers' liability insurance (the "D&O Policy") providing a primary layer of coverage in the amount of $20,000,000, underwritten by Ironclad Specialty Insurance Co. and placed through Ashford Wren & Co. (Attention: Lydia Carver, Senior Vice President). The D&O Policy was bound at pricing on March 2, 2023, and will become effective upon the Closing Date, with retroactive coverage for wrongful acts occurring on or after March 2, 2023. The Company and its subsidiaries are in compliance with the terms of all insurance policies to which they are a party or under which they are insured, and there are no claims pending under any such policies as to which coverage has been denied or disputed by the underwriters of such policies.

2(o). Compliance with Laws.

The Company and each of its subsidiaries are in compliance in all material respects with all applicable laws, statutes, rules, regulations, ordinances, orders, judgments, writs, and decrees of any governmental authority having jurisdiction over the Company, the U.S. Subsidiary, or any of their respective properties or assets, except where the failure to be in such compliance would not, individually or in the aggregate, have a Material Adverse Effect. Neither the Company nor any of its subsidiaries has received any written notice of any violation of any such law, statute, rule, regulation, ordinance, order, judgment, writ, or decree that would, individually or in the aggregate, have a Material Adverse Effect.

2(p). Related Party Transactions.

All transactions between or among the Company and any of its affiliates, officers, directors, or shareholders (or any family member or affiliate of any of the foregoing) are as disclosed in the Prospectus under the caption "Certain Relationships and Related Party Transactions," and all such transactions were entered into on terms no less favorable to the Company than would have been obtainable in a comparable arm's-length transaction with an unrelated third party.

2(q). Listing. The ADSs have been approved for listing on the Nasdaq Global Market under the ticker symbol "SBDX," subject only to official notice of issuance. The Company has complied with all applicable requirements of the Nasdaq Stock Market LLC in connection with such listing.

2(r). FINRA Matters.

No FINRA-affiliated person holds any equity interests in the Company or has any other interest in or relationship with the Company that would require disclosure pursuant to FINRA Rule 5110 or any other applicable rule of FINRA, except as has been disclosed to FINRA. FINRA has issued a letter confirming that it has no objection to the underwriting terms and arrangements described in the Registration Statement and the Prospectus.

2(s). Lock-Up Agreements.

Each of the persons and entities listed on Schedule II hereto has executed and delivered to the Representative a Lock-Up Agreement substantially in the form attached hereto as Exhibit A (each, a "Lock-Up Agreement"), pursuant to which each such person or entity has agreed, for a period of 180 days from the date of the Prospectus (i.e., from March 2, 2023 through August 29, 2023), not to offer, sell, contract to sell, pledge, grant any option to purchase, make any short sale of, or otherwise dispose of, directly or indirectly, any Ordinary Shares, ADSs, or any securities convertible into or exercisable or exchangeable for Ordinary Shares or ADSs, or publicly disclose the intention to do any of the foregoing, without the prior written consent of the Representative. The Lock-Up Agreements cover an aggregate of 23,480,000 Ordinary Shares, representing approximately 83.9% of the 28,000,000 Ordinary Shares outstanding immediately prior to the consummation of the offering contemplated hereby. The locked-up persons and entities and their respective share holdings are as set forth on Schedule II hereto. To the Company's knowledge, each Lock-Up Agreement is in full force and effect and is a legal, valid, and binding obligation of the party thereto, enforceable in accordance with its terms.

2(t). Foreign Private Issuer.

The Company qualifies as a "foreign private issuer" as such term is defined in Rule 405 under the Act and Rule 3b-4 under the Exchange Act. The Company is eligible to use Form 20-F for its annual reports under the Exchange Act and Form 6-K for current reports under the Exchange Act.

2(u). Use of Proceeds.

The Company intends to use the net proceeds from the offering of the ADSs contemplated hereby as described in the Prospectus under the caption "Use of Proceeds." The net proceeds to the Company from the offering (assuming full exercise of the Overallotment Option) are estimated to be approximately $76,275,000, after deducting the total underwriting discount of approximately $5,525,000 and estimated offering expenses payable by the Company of approximately $3,200,000. The Company currently intends to allocate such net proceeds approximately as follows:

The foregoing allocation of net proceeds represents the Company's current intentions based upon its present plans and business conditions. The Company reserves the right to adjust the allocation of net proceeds as described in the Prospectus.

SECTION 3. PURCHASE, SALE AND DELIVERY OF ADSs.

On the basis of the representations, warranties, and agreements herein contained, and subject to the terms and conditions herein set forth, the Company agrees to issue and sell to each of the Underwriters, and each of the Underwriters agrees, severally and not jointly, to purchase from the Company, at the purchase price set forth in Section 1(a) hereof, the number of Firm ADSs set forth opposite such Underwriter's name in Schedule I hereto. Each Underwriter's obligation to purchase Firm ADSs shall be several and not joint; no Underwriter shall be responsible for the obligation of any other Underwriter to purchase Firm ADSs, except as provided in Section 12 hereof.

If the Overallotment Option is exercised, each Underwriter shall purchase, at the purchase price set forth in Section 1(b) hereof, the number of Option ADSs (subject to such adjustments as the Representative may determine to avoid fractional ADSs) that bears the same proportion to the total number of Option ADSs to be purchased pursuant to such exercise as the number of Firm ADSs to be purchased by such Underwriter bears to the total number of Firm ADSs. The Overallotment Option shall be exercised by delivery by the Representative to the Company of a written notice setting forth the aggregate number of Option ADSs to be purchased and the date on which the Option ADSs are to be delivered (each such date, an "Option Closing Date"). Such notice may be given at any time, and from time to time, within 30 days from the date of the Prospectus.

Certificates or book-entry positions representing the ADSs to be delivered hereunder shall be registered in such names and in such denominations as the Representative shall request in writing not later than two (2) full business days prior to the Closing Date or any Option Closing Date, as applicable. The ADSs shall be made available for checking and packaging by the Representative at such location as DTC shall designate not later than 1:00 p.m. (New York City time) on the business day preceding the Closing Date or any Option Closing Date, as applicable. Delivery of the ADSs shall be made through the facilities of DTC unless the Representative shall otherwise instruct.

The Company shall cause its registrar and transfer agent to deposit, or cause to be deposited, the Ordinary Shares underlying the ADSs with the Depositary (Meridian Trust Company, N.A.), or its custodian, in exchange for the issuance by the Depositary of the ADSs to be delivered hereunder. Such deposit shall be made in sufficient time to permit timely delivery of the ADSs on the Closing Date and each Option Closing Date, as applicable, through the facilities of DTC.

SECTION 4. OFFERING BY THE UNDERWRITERS.

The several Underwriters will offer the ADSs for sale to the public upon the terms set forth in the Prospectus. The ADSs shall be offered for sale to the public at the Public Offering Price of $11.0769 per ADS.

It is understood that the several Underwriters propose to offer the ADSs for sale to the public as set forth in the Prospectus. The Underwriters may from time to time increase or decrease the public offering price after the initial offering to such extent as they may determine. In addition, the Underwriters may allow concessions and reallowances to selected broker-dealers who are members of FINRA in the amounts and upon the terms set forth in the Prospectus.

Each Underwriter, severally and not jointly, represents and agrees that (i) it has not and will not use, authorize use of, refer to, or participate in the planning for use of, any Free Writing Prospectus, other than (A) any Free Writing Prospectus approved in advance in writing by the Company and the Representative, (B) the documents listed on Schedule III hereto (if any), or (C) any Free Writing Prospectus prepared by such Underwriter and approved in advance in writing by the Company, and (ii) it has complied and will comply with all applicable provisions of the Act, the Rules and Regulations, and the rules and regulations of FINRA in connection with the offering and sale of the ADSs as contemplated herein.

SECTION 5. COVENANTS OF THE COMPANY.

The Company covenants and agrees with each of the Underwriters as follows:

5(a). Amendments and Supplements.

The Company shall not, during such period as the Prospectus is required by law to be delivered (whether physically or through compliance with Rule 172 under the Act) in connection with the sale of the ADSs, file any amendment or supplement to the Registration Statement or the Prospectus, unless a copy thereof shall first have been submitted to the Representative a reasonable time prior to the filing thereof and the Representative shall not have objected thereto in good faith (such consent not to be unreasonably withheld, conditioned, or delayed).

5(b). Delivery of Copies.

The Company shall furnish to the Representative, without charge, as many copies of the Prospectus (and any amendments or supplements thereto) as the Representative may reasonably request for the purposes contemplated by the Act. The Company consents to the use of the Prospectus (and any amendments or supplements thereto) by the several Underwriters in connection with the offering and sale of the ADSs.

5(c). Blue Sky Compliance.

The Company shall cooperate with the Underwriters and underwriters' counsel in the qualification or registration of the ADSs for offer and sale under the securities or "blue sky" laws of such jurisdictions as the Representative may designate and shall continue such qualification or registration in effect so long as required for the distribution of the ADSs; provided, however, that the Company shall not be required to (i) qualify as a foreign corporation or other entity in any jurisdiction where it is not so qualified, (ii) take any action that would subject it to general service of process in any jurisdiction where it is not so subject, or (iii) subject itself to taxation in any jurisdiction where it is not so subject.

5(d). Earnings Statement.

The Company shall make generally available to its security holders and to the Representative, as soon as practicable, an earnings statement covering a period of at least twelve (12) months commencing after the effective date of the Registration Statement that satisfies the provisions of Section 11(a) of the Act and Rule 158 thereunder.

5(e). Use of Proceeds.

The Company shall apply the net proceeds from the sale of the ADSs in the manner described in the Prospectus under the caption "Use of Proceeds."

5(f). Restriction on Issuance of Securities.

For a period of 180 days after the date of the Prospectus (i.e., from March 2, 2023 through August 29, 2023) (the "Restricted Period"), the Company shall not, without the prior written consent of the Representative (which consent may be withheld in the sole discretion of the Representative), directly or indirectly, (i) issue, sell, offer to sell, contract to sell, or grant any option, right, or warrant to purchase, any Ordinary Shares, ADSs, or any securities convertible into or exercisable or exchangeable for Ordinary Shares or ADSs, (ii) file any registration statement under the Act with respect to any Ordinary Shares, ADSs, or any securities convertible into or exercisable or exchangeable for Ordinary Shares or ADSs, or (iii) enter into any swap or other agreement or any transaction that transfers, in whole or in part, directly or indirectly, the economic consequence of ownership of any Ordinary Shares, ADSs, or any securities convertible into or exercisable or exchangeable for Ordinary Shares or ADSs, whether any such swap or transaction described in clause (i), (ii), or (iii) above is to be settled by delivery of Ordinary Shares, ADSs, or such other securities, in cash, or otherwise.

The foregoing restrictions shall not apply to (A) the issuance by the Company of Ordinary Shares underlying the ADSs offered and sold hereunder (including the Option ADSs), (B) the issuance by the Company of Ordinary Shares, options to purchase Ordinary Shares, or other equity-based awards pursuant to the Company's equity incentive plans as in effect on the date hereof, as described in the Prospectus, and (C) the issuance by the Company of Ordinary Shares upon the exercise of options or other equity awards outstanding on the date hereof.

5(g). Listing. The Company shall use its reasonable best efforts to effect and maintain the listing of the ADSs on the Nasdaq Global Market (or any successor trading market or quotation system of comparable standing).

5(h). DTC Eligibility.

The Company shall cooperate with the Representative and DTC to permit the ADSs to be eligible for clearance and settlement through the facilities of DTC, including, without limitation, compliance with all applicable DTC rules and regulations.

5(i). Reporting. For so long as the Company is subject to the reporting requirements of Section 13 or 15(d) of the Exchange Act, the Company shall comply with its reporting obligations thereunder, including the timely filing of all annual reports on Form 20-F and current reports on Form 6-K.

SECTION 6. CONDITIONS TO THE OBLIGATIONS OF THE UNDERWRITERS.

The obligations of the several Underwriters to purchase and pay for the ADSs as provided herein shall be subject to the accuracy of the representations and warranties of the Company herein contained as of the date hereof, the Closing Date, and each Option Closing Date (if any), to the performance by the Company of its covenants and agreements herein contained, and to the following additional conditions:

6(a). Effectiveness of Registration Statement.

The Registration Statement on Form S-1 (File No. 333-268514) shall have been declared effective by the Commission and shall remain effective, and no stop order suspending the effectiveness of the Registration Statement shall have been issued by the Commission and no proceeding for that purpose shall have been initiated or threatened by the Commission. Any request by the Commission for additional information to be included in the Registration Statement or the Prospectus, or otherwise, shall have been complied with to the reasonable satisfaction of the Representative.

6(b). No Material Adverse Change.

Since the date of the most recent financial statements included in the Registration Statement and the Prospectus (December 31, 2022), there shall not have occurred any Material Adverse Effect on the business, properties, assets, liabilities, operations, financial condition, or results of operations of the Company and its subsidiaries, taken as a whole, except as set forth in or contemplated by the Registration Statement and the Prospectus, and no event shall have occurred or condition shall exist that would reasonably be expected to result in a Material Adverse Effect.

6(c). Opinion of Issuer's Counsel.

The Representative shall have received the favorable written opinion and negative assurance (10b-5) letter of Calderwood & Harkness LLP, counsel to the Company, addressed to the Underwriters, dated the Closing Date (or the applicable Option Closing Date), in form and substance satisfactory to the Representative and to Pellwick Raine LLP, counsel to the Underwriters, covering, among other things:

(i) The Company is a private company limited by shares duly incorporated and validly existing under the laws of Ireland, with full corporate power and authority to own, lease, and operate its properties and to conduct its business as described in the Prospectus;

(ii) The Ordinary Shares underlying the ADSs to be issued and sold hereunder have been duly authorized and, when issued and delivered to the Depositary against payment therefor as provided in this Agreement, will be validly issued, fully paid, and non-assessable;

(iii) This Agreement has been duly authorized, executed, and delivered by the Company and constitutes a legal, valid, and binding obligation of the Company, enforceable against the Company in accordance with its terms, subject to customary exceptions;

(iv) The Deposit Agreement has been duly authorized, executed, and delivered by the Company and constitutes a legal, valid, and binding obligation of the Company, enforceable against the Company in accordance with its terms, subject to customary exceptions;

(v) The Registration Rights Agreement has been duly authorized, executed, and delivered by the Company and constitutes a legal, valid, and binding obligation of the Company, enforceable against the Company in accordance with its terms, subject to customary exceptions;

(vi) The Registration Statement has been declared effective under the Act; to the knowledge of such counsel, no stop order suspending the effectiveness thereof has been issued and no proceeding for that purpose has been initiated or threatened by the Commission;

(vii) The Registration Statement and the Prospectus (other than the financial statements and supporting schedules included therein, as to which such counsel need not express any opinion) comply as to form in all material respects with the applicable requirements of the Act and the Rules and Regulations;

(viii) Negative assurance to the effect that nothing has come to such counsel's attention that causes it to believe that (A) the Registration Statement, at the time it became effective, contained any untrue statement of a material fact or omitted to state any material fact required to be stated therein or necessary to make the statements therein not misleading, or (B) the Prospectus, as of its date and as of the Closing Date (or the applicable Option Closing Date), contained or contains any untrue statement of a material fact or omitted or omits to state any material fact necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading (in each case, other than the financial statements and supporting schedules included therein, as to which such counsel need not provide any negative assurance); and

(ix) Such other matters as the Representative or Pellwick Raine LLP may reasonably request.

Such opinion and negative assurance letter shall be signed by Theodore Langston, Responsible Partner at Calderwood & Harkness LLP.

6(d). Opinion of Underwriters' Counsel.

The Representative shall have received the favorable written opinion of Pellwick Raine LLP (Harrison Blake, Partner), counsel to the Underwriters, dated the Closing Date (or the applicable Option Closing Date), with respect to the issuance and sale of the ADSs, the Registration Statement, the Prospectus, and such other matters as the Representative may reasonably request. In rendering such opinion, Pellwick Raine LLP may rely as to matters of Irish law upon the opinion of Calderwood & Harkness LLP (or other Irish counsel satisfactory to the Representative) and as to matters of fact upon certificates of officers of the Company and public officials.

6(e). Officers' Certificate.

The Representative shall have received a certificate, dated the Closing Date (or the applicable Option Closing Date), signed by Dr. Cormac Tierney, Chief Executive Officer of the Company, and Ronan McBride, Chief Financial Officer of the Company, to the effect that:

(i) The representations and warranties of the Company set forth in Section 2 of this Agreement are true and correct in all material respects as of the Closing Date (or the applicable Option Closing Date) with the same force and effect as if made on and as of such date;

(ii) The Company has performed and complied with all agreements, covenants, and conditions required by this Agreement to be performed or complied with by it at or prior to the Closing Date (or the applicable Option Closing Date);

(iii) No stop order suspending the effectiveness of the Registration Statement has been issued by the Commission and no proceeding for that purpose has been initiated or, to the knowledge of the signatories, threatened by the Commission;

(iv) Since December 31, 2022, there has been no Material Adverse Effect on the business, properties, assets, liabilities, operations, financial condition, or results of operations of the Company and its subsidiaries, taken as a whole, except as set forth in or contemplated by the Registration Statement and the Prospectus; and

(v) Such other matters as the Representative may reasonably request.

6(f). Secretary's Certificate.

The Representative shall have received a certificate of the Secretary (or equivalent officer) of the Company, dated the Closing Date, attaching and certifying as true, correct, and complete copies of:

(i) Resolutions duly adopted by the board of directors of the Company authorizing the initial public offering of the ADSs, the execution, delivery, and performance of this Agreement, the Deposit Agreement, and the Registration Rights Agreement, and the issuance of up to 7,666,667 Ordinary Shares underlying the ADSs (including the Ordinary Shares underlying the Option ADSs);

(ii) Resolutions duly adopted by the shareholders of the Company amending the authorized share capital of the Company to 100,000,000 Ordinary Shares at a nominal value of €0.01 per share and authorizing the transactions contemplated by this Agreement;

(iii) An incumbency certificate identifying the name, title, and specimen signature of each officer and director of the Company authorized to execute the Transaction Documents, including Dr. Cormac Tierney (Chief Executive Officer), Dr. Siobhán Kelleher (Chief Technology Officer), Ronan McBride (Chief Financial Officer), Fiona Drennan (General Counsel and Company Secretary), and Declan Whitfield (Chairman of the Board of Directors); and

(iv) The memorandum and articles of association of the Company as currently in effect.

6(g). Comfort Letters.

The Representative shall have received from Calderwood & Associates LLP (Patricia Yuen, Engagement Partner), the Company's independent registered public accounting firm, comfort letters in form and substance satisfactory

UNDERWRITING AGREEMENT
(Execution Version)
March 2, 2023
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UNDERWRITING AGREEMENT
March 2, 2023
Keystone Mercer & Co., LLC 280 Park Avenue, 14th Floor New York, NY 10017
As Representative of the Several Underwriters Named in Schedule I Hereto
Ladies and Gentlemen:
Solstice Biomedical Devices Limited, a private company limited by shares incorporated under the laws of Ireland (Companies Registration Office Number 587412), with its registered office at Unit 7, Lakeview Technology Campus, Parkmore East, Galway, H91 XK72, Ireland (the "Company"), proposes to issue and sell to the several underwriters named in Schedule I hereto (collectively, the "Underwriters"), for whom Keystone Mercer & Co., LLC is acting as representative (the "Representative"), American Depositary Shares ("ADSs"), each representing one (1) ordinary share, nominal value €0.01 per share, of the Company (the "Ordinary Shares"), on the terms and conditions set forth in this Underwriting Agreement (this "Agreement").
The ADSs are to be issued pursuant to the Deposit Agreement dated as of March 2, 2023 (the "Deposit Agreement"), among the Company, Meridian Trust Company, N.A., as depositary (the "Depositary"), and all holders and beneficial owners of ADSs issued thereunder. The ADSs have been assigned CUSIP Number 83472R 109 and have been approved for listing on the Nasdaq Global Market under the ticker symbol "SBDX," subject only to official notice of issuance.
The Company has filed with the Securities and Exchange Commission (the "Commission" or the "SEC") a registration statement on Form S-1 (File No. 333-268514), including a prospectus, relating to the ADSs to be sold hereunder. Such registration statement was declared effective by the Commission on February 28, 2023. The Company initially submitted a Confidential Draft Registration Statement to the Commission on November 14, 2022, and thereafter filed a first amendment on January 18, 2023, in response to the Commission's first-round comment letter dated December 22, 2022, and a second amendment on February 17, 2023, in response to the Commission's second-round comment letter dated February 8, 2023. As used in this Agreement:
(a) "Registration Statement" means the registration statement on Form S-1 (File No. 333-268514), as amended at the time it became effective and as thereafter amended by any post-effective amendments thereto, including all exhibits, financial statements, and schedules thereto and all documents incorporated by reference therein, and including any information deemed to be a part thereof pursuant to Rule 430A under the Securities Act of 1933, as amended (the "Act");
(b) "Prospectus" means the final prospectus relating to the ADSs dated March 2, 2023, as filed with the Commission pursuant to Rule 424(b) of the rules and regulations of the Commission under the Act (the "Rules and Regulations"), including all documents incorporated by reference therein;
(c) "Preliminary Prospectus" means any preliminary prospectus relating to the ADSs included in the Registration Statement or filed with the Commission pursuant to Rule 424(a) of the Rules and Regulations;
(d) "Time of Sale Information" means the information included in the Preliminary Prospectus dated February 28, 2023, together with the information set forth on Schedule III hereto (if any) and each Free Writing Prospectus (as defined below) issued at or prior to the Applicable Time, taken together;
(e) "Free Writing Prospectus" means each "free writing prospectus" (as defined in Rule 405 under the Act) relating to the ADSs that is required to be filed with the Commission by the Company or any Underwriter;
(f) "Applicable Time" means the time of pricing on March 2, 2023; and
(g) "Exchange Act" means the Securities Exchange Act of 1934, as amended, and the rules and regulations of the Commission thereunder.
All references in this Agreement to the Registration Statement, any Preliminary Prospectus, the Prospectus, or any Free Writing Prospectus, or any amendment or supplement to any of the foregoing, shall be deemed to include any copy filed with the Commission pursuant to the Electronic Data Gathering, Analysis and Retrieval System ("EDGAR").
All references in this Agreement to financial statements and schedules and other information that is "contained," "included," or "stated" in the Registration Statement, any Preliminary Prospectus, or the Prospectus (or other references of like import) shall be deemed to include all such financial statements and schedules and other information that is incorporated by reference in the Registration Statement, any Preliminary Prospectus, or the Prospectus, as the case may be.
SECTION 1. SALE AND PURCHASE OF ADSs.
1(a). Firm ADSs.
Upon the basis of the representations, warranties, and agreements of the Company herein contained, and subject to the terms and conditions set forth herein, the Company agrees to issue and sell to the several Underwriters, and each of the Underwriters agrees, severally and not jointly, to purchase from the Company, the number of ADSs (the "Firm ADSs") set forth opposite the name of such Underwriter in Schedule I hereto, at a purchase price of $10.3569 per ADS (which is equal to the public offering price of $11.0769 per ADS (the "Public Offering Price"), less the underwriting discount of $0.71999985 per ADS, representing 6.5% of the Public Offering Price). The total number of Firm ADSs to be sold by the Company and purchased by the several Underwriters hereunder shall be 6,666,667 ADSs. The aggregate underwriting discount on the Firm ADSs shall be approximately $4,800,000, representing 6.5% of the aggregate Public Offering Price of the Firm ADSs.
1(b). Option ADSs (Overallotment).
In addition, the Company hereby grants to the several Underwriters an option (the "Overallotment Option") to purchase, severally and not jointly, up to an additional 1,000,000 ADSs (the "Option ADSs" and, together with the Firm ADSs, the "ADSs") at the same purchase price per ADS as set forth in Section 1(a) above (i.e., $10.3569 per ADS), less an amount per ADS equal to any dividends or distributions declared by the Company and payable on the Firm ADSs but not payable on the Option ADSs. The Overallotment Option may be exercised in whole or in part at any time and from time to time on or before the thirtieth (30th) day after the date of the Prospectus (i.e., exercisable through and including April 1, 2023). The Overallotment Option shall be exercisable solely for the purpose of covering over-allotments, if any, made in connection with the offering of the Firm ADSs.
Upon full exercise of the Overallotment Option, the total number of ADSs to be sold by the Company and purchased by the several Underwriters hereunder shall be 7,666,667 ADSs. Upon full exercise, the aggregate gross proceeds to the Company from the offering shall be approximately $85,000,000 (being 7,666,667 ADSs multiplied by the Public Offering Price of $11.0769, rounded to the nearest thousand). The total underwriting discount upon full exercise of the Overallotment Option shall be approximately $5,525,000 (representing 6.5% of the aggregate gross proceeds of approximately $85,000,000). The net proceeds to the Company, before deduction of estimated offering expenses of approximately $3,200,000, upon full exercise of the Overallotment Option shall be approximately $79,475,000.
If the Overallotment Option is exercised, each Underwriter shall purchase the number of Option ADSs that bears the same proportion to the total number of Option ADSs to be purchased as the number of Firm ADSs set forth opposite the name of such Underwriter in Schedule I bears to the total number of Firm ADSs, subject to such adjustments as the Representative may determine to avoid fractional ADSs.
1(c). Payment and Delivery — Firm ADSs.
Payment for and delivery of the Firm ADSs shall be made at the offices of Calderwood & Harkness LLP, 425 Lexington Avenue, New York, NY 10174 (or such other location as the Representative and the Company may agree upon in writing), at 10:00 a.m. (New York City time) on March 21, 2023 (the "Closing Date"), or at such other date as the Representative and the Company may agree upon in writing; provided, however, that the Closing Date shall not be later than five (5) business days after the originally scheduled Closing Date without the written consent of the Representative. For the avoidance of doubt, the originally expected closing date was March 7, 2023; the actual Closing Date of March 21, 2023 has been agreed to by the Representative and the Company in order to accommodate ADS settlement mechanics and the deposit of underlying Ordinary Shares with the Depositary.
On the Closing Date, the Company shall deliver or cause to be delivered the Firm ADSs to the account of the Representative through the facilities of The Depository Trust Company ("DTC") for the accounts of the several Underwriters, against payment of the aggregate purchase price therefor by wire transfer of immediately available funds to the Company's designated account maintained by Northvale Fiduciary Services LLC, as escrow agent, located at 1 Liberty Plaza, Suite 4200, New York, NY 10006 (Attention: Angela Morse, Director) (the "Escrow Agent"), for prompt release to the Company upon satisfaction of the conditions set forth in the escrow letter agreement between the Company, the Representative, and the Escrow Agent. The Firm ADSs so to be delivered are to be made available for checking by the Representative at the offices of DTC or its designated custodian not later than 1:00 p.m. (New York City time) on the business day preceding the Closing Date.
1(d). Payment and Delivery — Option ADSs.
The Overallotment Option shall be exercisable by delivery by the Representative of written notice (or notice by facsimile or electronic mail confirmed in writing) to the Company setting forth the number of Option ADSs to be purchased and the date and time for such delivery and payment (each, an "Option Closing Date"). Each Option Closing Date shall be determined by the Representative but shall not be earlier than the Closing Date nor earlier than the second (2nd) business day after the date on which the Overallotment Option shall have been exercised. Payment for and delivery of the Option ADSs shall be made at the same location and in the same manner as set forth in Section 1(c) above with respect to the Firm ADSs, mutatis mutandis.
SECTION 2. REPRESENTATIONS AND WARRANTIES OF THE COMPANY.
The Company represents and warrants to, and agrees with, each of the Underwriters that, as of the date hereof, the Closing Date, and each Option Closing Date (if any):
2(a). Registration Statement and Prospectus.
The Registration Statement on Form S-1 (File No. 333-268514) has been prepared by the Company in conformity with the requirements of the Act and the Rules and Regulations and was filed with the Commission. The Registration Statement was declared effective by the Commission on February 28, 2023. The Confidential Draft Registration Statement was initially submitted to the Commission on November 14, 2022 pursuant to the Jumpstart Our Business Startups Act of 2012 (the "JOBS Act"). A first amendment to the Confidential Draft Registration Statement was filed with the Commission on January 18, 2023, in response to the Commission's first-round comment letter dated December 22, 2022. A second amendment was filed with the Commission on February 17, 2023, in response to the Commission's second-round comment letter dated February 8, 2023. The Commission has not issued any further comments with respect to the Registration Statement that remain outstanding as of the date hereof.
The Registration Statement, including the Prospectus and all amendments and supplements thereto, at the time the Registration Statement became effective and at each subsequent amendment thereto, complied and will comply in all material respects with the requirements of the Act and the Rules and Regulations. The Prospectus, as of the date thereof and as of the Closing Date (and each Option Closing Date, if any), complied and will comply in all material respects with the requirements of the Act and the Rules and Regulations.
No stop order suspending the effectiveness of the Registration Statement has been issued by the Commission, and no proceeding for that purpose has been initiated or, to the knowledge of the Company, threatened by the Commission. No order preventing or suspending the use of any Preliminary Prospectus or the Prospectus has been issued by the Commission, and no proceeding for that purpose has been initiated or, to the knowledge of the Company, threatened by the Commission.
The Registration Statement, at the time it became effective and as of the date hereof, did not and does not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order to make the statements therein not misleading. The Prospectus, as of its date and as of the Closing Date (and each Option Closing Date, if any), did not and will not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading. The Time of Sale Information, at the Applicable Time, did not contain any untrue statement of a material fact or omit to state a material fact necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading. The preceding two sentences do not apply to statements in or omissions from the Registration Statement, the Prospectus, or the Time of Sale Information made in reliance upon and in conformity with written information furnished to the Company by any Underwriter through the Representative expressly for use therein.
Each Preliminary Prospectus filed as part of the Registration Statement or filed pursuant to Rule 424 under the Act complied when so filed in all material respects with the requirements of the Act and the Rules and Regulations. Each Free Writing Prospectus, if any, that the Company is required to file pursuant to Rule 433(d) under the Act has been, or will be, filed with the Commission in accordance with the requirements of the Act and the Rules and Regulations. Each Free Writing Prospectus, as of its issue date and at all subsequent times through the completion of the public offering and sale of the ADSs or until any earlier date on which the Company notified or notifies the Representative that such Free Writing Prospectus is no longer being used in connection with the offering, did not, does not, and will not include any information that conflicts with the information contained in the Registration Statement or the Prospectus.
2(b). Organization and Good Standing.
The Company is a private company limited by shares duly incorporated and validly existing under the laws of Ireland, registered with the Companies Registration Office of Ireland under Number 587412. The Company has full corporate power and authority to own, lease, and operate its properties and to conduct its business as described in the Prospectus and to enter into and perform its obligations under this Agreement. The Company is duly qualified to do business and is in good standing (or the equivalent thereof under the laws of the applicable jurisdiction) in each jurisdiction in which the character of the business conducted by it or the nature or location of the properties owned or leased by it requires such qualification, except where the failure to be so qualified or in good standing would not, individually or in the aggregate, have a Material Adverse Effect (as defined below).
As used herein, "Material Adverse Effect" means (i) a material adverse change in, or material adverse effect upon, the business, properties, assets, liabilities, operations, financial condition, or results of operations of the Company and its subsidiaries, taken as a whole, (ii) a material impairment of the ability of the Company to perform its obligations under this Agreement, the Deposit Agreement, or the Registration Rights Agreement (as defined below), or (iii) a material impairment of the legality, validity, or enforceability of this Agreement, the Deposit Agreement, or the Registration Rights Agreement.
Solstice Surgical Inc. is a corporation duly incorporated and validly existing under the laws of the State of Delaware (Employer Identification Number 87-4231568), with its principal office at 200 West Adams Street, Suite 1100, Chicago, IL 60606 (the "U.S. Subsidiary"). The U.S. Subsidiary is a wholly owned subsidiary of the Company and is duly qualified to do business and is in good standing in each jurisdiction in which the character of the business conducted by it or the nature or location of the properties owned or leased by it requires such qualification, except where the failure to be so qualified or in good standing would not, individually or in the aggregate, have a Material Adverse Effect. The U.S. Subsidiary has full corporate power and authority to own, lease, and operate its properties and to conduct its business as described in the Prospectus. Except for the U.S. Subsidiary, the Company does not have any other subsidiaries.
2(c). Capitalization.  The authorized share capital of the Company consists of 100,000,000 Ordinary Shares, nominal value €0.01 per share, as amended by shareholder resolution in connection with the transactions contemplated by this Agreement. As of the date hereof, prior to giving effect to the sale of the ADSs contemplated hereby, 28,000,000 Ordinary Shares are issued and outstanding. Immediately after giving effect to the sale of the Firm ADSs contemplated hereby, 34,666,667 Ordinary Shares will be issued and outstanding. Immediately after giving effect to the sale of the Firm ADSs and the full exercise of the Overallotment Option, 35,666,667 Ordinary Shares will be issued and outstanding. All of the outstanding Ordinary Shares have been duly authorized and validly issued and are fully paid and non-assessable (within the meaning of the Irish Companies Act 2014) and were not issued in violation of any preemptive or similar rights.
The Ordinary Shares underlying the ADSs to be issued and sold by the Company hereunder have been duly authorized by all necessary corporate action on the part of the Company and, when issued and delivered to the Depositary (or its custodian) against payment therefor as provided herein, will be validly issued, fully paid, and non-assessable (within the meaning of the Irish Companies Act 2014) and will not have been issued in violation of any preemptive or similar rights.
No preemptive rights or other similar rights of shareholders exist with respect to any of the Ordinary Shares or the ADSs. Except as set forth in the Prospectus, there are no outstanding options, warrants, or other rights to purchase, or any outstanding securities convertible into or exchangeable for, any Ordinary Shares or ADSs of the Company. The description of the Company's authorized and outstanding share capital set forth in the Prospectus under the caption "Description of Share Capital" is accurate in all material respects as of the dates indicated therein.
2(d). Authorization.  The Company has full corporate power and authority to execute, deliver, and perform its obligations under this Agreement, the Deposit Agreement, and the Registration Rights Agreement dated as of March 2, 2023 among the Company, Greystone Ventures Fund III, L.P., Pinnacle Health Innovation Fund, L.P., and Elkridge Growth Partners II, L.P. (the "Registration Rights Agreement"). The execution and delivery of this Agreement by the Company, the consummation by the Company of the transactions contemplated hereby, and the performance by the Company of its obligations hereunder have been duly authorized by all necessary corporate action on the part of the Company, including resolutions of the board of directors of the Company and resolutions of the shareholders of the Company (including, without limitation, the shareholder resolution amending the authorized share capital of the Company to 100,000,000 Ordinary Shares, nominal value €0.01 per share, and the shareholder resolution authorizing the initial public offering of ADSs and the execution and delivery of this Agreement and the other Transaction Documents (as defined below)). This Agreement has been duly executed and delivered by the Company and, assuming the due authorization, execution, and delivery hereof by the Representative, constitutes a legal, valid, and binding obligation of the Company, enforceable against the Company in accordance with its terms, except as may be limited by (i) bankruptcy, insolvency, reorganization, moratorium, examinership, or similar laws relating to or affecting the enforcement of creditors' rights generally, and (ii) general equitable principles (whether such enforceability is considered in a proceeding in equity or at law).
As used herein, "Transaction Documents" means this Agreement, the Deposit Agreement, the Registration Rights Agreement, and each Lock-Up Agreement (as defined below).
2(e). No Conflicts.
The execution, delivery, and performance of this Agreement and each of the other Transaction Documents by the Company, the issuance and sale of the ADSs (and the underlying Ordinary Shares), and the consummation of the transactions contemplated hereby and thereby will not (i) violate, conflict with, or result in a breach of any provision of the memorandum and articles of association of the Company (as amended and currently in effect) or the certificate of incorporation, bylaws, or other organizational documents of the U.S. Subsidiary, (ii) violate or result in a breach of any applicable law, statute, rule, regulation, judgment, order, writ, or decree of any governmental authority having jurisdiction over the Company, the U.S. Subsidiary, or any of their respective properties or assets, (iii) result in a breach of, or constitute a default (or an event that, with the giving of notice or lapse of time, or both, would constitute a default) under, or give rise to any right of termination, amendment, acceleration, or cancellation of, any material agreement, mortgage, deed of trust, indenture, note, bond, license, lease agreement, or other instrument or obligation to which the Company or the U.S. Subsidiary is a party or by which any of them or any of their respective properties or assets are bound, or (iv) result in the creation or imposition of any lien, charge, claim, security interest, encumbrance, right of first refusal, or other restriction of any kind on any property or asset of the Company or the U.S. Subsidiary.
2(f). No Consents Required.
No consent, approval, authorization, order, license, registration, or qualification of or with any court, governmental authority, or body, or any regulatory or self-regulatory organization, is required in connection with the execution, delivery, and performance of this Agreement by the Company, the issuance and sale of the ADSs (and the underlying Ordinary Shares), or the consummation of the transactions contemplated hereby, except (i) such as have already been obtained or made, including the effectiveness of the Registration Statement under the Act, the approval of the listing of the ADSs on the Nasdaq Global Market, and the receipt of the no-objection letter from the Financial Industry Regulatory Authority, Inc. ("FINRA"), and (ii) such as may be required under state securities or "blue sky" laws in connection with the purchase and distribution of the ADSs by the Underwriters and the qualification of the ADSs for listing on the Nasdaq Global Market, which filings and registrations will be effected in accordance with Section 5(c) of this Agreement.
2(g). Financial Statements.
The audited consolidated financial statements of the Company for the fiscal years ended December 31, 2020 ("FY2020"), December 31, 2021 ("FY2021"), and December 31, 2022 ("FY2022"), included in the Registration Statement and the Prospectus, together with the related notes thereto and the independent auditor's reports thereon of Calderwood & Associates LLP (PCAOB ID No. 4518; engagement partner: Patricia Yuen, CPA), have been prepared in conformity with International Financial Reporting Standards as issued by the International Accounting Standards Board ("IFRS") applied on a consistent basis throughout the periods involved (except as may be noted therein or in the notes thereto), and fairly present in all material respects the financial position of the Company as of the dates thereof and the results of operations and cash flows for the periods then ended.
The key financial metrics for FY2022, as reflected in the financial statements included in the Prospectus, are as follows:
The selected financial data and the summary financial information included in the Registration Statement and the Prospectus present fairly in all material respects the information shown therein and have been compiled on a basis consistent with that of the audited financial statements of the Company included in the Registration Statement and the Prospectus. The pro forma financial information, if any, included in the Registration Statement and the Prospectus has been properly compiled and prepared in accordance with the applicable requirements of the Act and the Rules and Regulations and the assumptions underlying such pro forma financial information are reasonable and are set forth in the Registration Statement and the Prospectus.
Calderwood & Associates LLP, which has audited the financial statements included in the Prospectus and delivered its reports with respect thereto, is a registered public accounting firm as required by the Act and the Rules and Regulations and the rules of the Public Company Accounting Oversight Board.
2(h). No Material Adverse Change.
Since December 31, 2022, the date of the most recent balance sheet included in the Registration Statement and the Prospectus, (i) there has been no Material Adverse Effect on the business, properties, assets, liabilities, operations, financial condition, results of operations, or prospects of the Company and its subsidiaries, taken as a whole, whether or not arising from transactions in the ordinary course of business, except as set forth in or contemplated by the Prospectus, (ii) the Company and its subsidiaries, taken as a whole, have not incurred any material liability or obligation, direct or contingent, other than in the ordinary course of business, (iii) the Company has not declared or paid any dividend or made any other distribution on or in respect of its Ordinary Shares, and (iv) there has been no change in the share capital or long-term debt of the Company or any of its subsidiaries, or any grants or issuances of stock options, restricted shares, or other equity-based awards by the Company, except in each case as described in or contemplated by the Prospectus.
2(i). Intellectual Property.
The Company and its subsidiaries own or have adequate rights to use all patents, patent applications, trademarks, trademark applications, service marks, trade names, trade secrets, copyrights, licenses, domain names, information, technology, know-how, and other intellectual property (collectively, "intellectual Property") material to the conduct of the business of the Company and its subsidiaries as described in the Prospectus, free and clear of all liens, encumbrances, defects, or other restrictions, except as would not, individually or in the aggregate, have a Material Adverse Effect. The Company's material registered intellectual Property includes, without limitation, the trademarks NeuroPath™ and OrthoSync™, as well as the patent portfolio described in the Prospectus under the caption "Business — Intellectual Property."
To the Company's knowledge, neither the Company nor any of its subsidiaries is infringing, misappropriating, or otherwise violating the intellectual Property rights of any third party. No claim, action, suit, investigation, or proceeding relating to the intellectual Property of the Company or its subsidiaries, including any claim of infringement, misappropriation, or violation by or against the Company or any of its subsidiaries, has been instituted, is pending, or, to the Company's knowledge, has been threatened, in writing or otherwise, by or against the Company or any of its subsidiaries.
2(j). Regulatory Compliance.
The Company and its subsidiaries hold all material permits, licenses, approvals, clearances, registrations, exemptions, and authorizations from governmental and regulatory authorities (collectively, "Permits") necessary for the conduct of the business of the Company and its subsidiaries as described in the Prospectus. Such Permits are valid and in full force and effect, and the Company and its subsidiaries are in compliance with the terms and conditions of all such Permits in all material respects.
Without limiting the generality of the foregoing:
(i) The NeuroPath™ Guided Navigation System received clearance from the U.S. Food and Drug Administration (the "FDA") pursuant to a premarket notification under Section 510(k) of the Federal Food, Drug, and Cosmetic Act, as amended (the "FD&C Act"), bearing submission number K211847, with clearance granted on June 14, 2021. The NeuroPath™ Guided Navigation System also holds a valid CE Mark under the Medical Devices Directive (93/42/EEC) / Medical Device Regulation (EU) 2017/745 transition provisions, with such CE Mark valid through May 2025.
(ii) The OrthoSync™ Intraoperative Imaging Platform is the subject of an Investigational Device Exemption ("IDE") bearing number G220035, which was approved by the FDA on September 2, 2022. A pivotal clinical trial pursuant to such IDE is currently being conducted at six (6) clinical trial sites in the United States. The Company is in compliance in all material respects with the terms and conditions of the approved IDE, including applicable requirements of 21 C.F.R. Part 812.
(iii) The Company and its subsidiaries are in compliance in all material respects with all applicable healthcare and regulatory laws, including the FD&C Act, the regulations promulgated thereunder, the EU Medical Device Regulation, and all other applicable laws and regulations relating to the design, development, testing, manufacturing, labeling, marketing, distribution, import, export, and commercialization of the Company's products.
Neither the Company nor any of its subsidiaries has received any written notice from the FDA, any other U.S. or foreign governmental authority, or any institutional review board alleging or asserting material noncompliance with the FD&C Act, the IDE regulations, or any other applicable law, regulation, or Permit. There are no pending or, to the Company's knowledge, threatened claims, suits, proceedings, hearings, investigations, charges, complaints, demands, or injunctions against the Company or any of its subsidiaries relating to any regulatory matter that would, individually or in the aggregate, have a Material Adverse Effect.
2(k). Tax Matters.
The Company and each of its subsidiaries have filed all material federal, state, local, and foreign tax returns required to be filed by them and have paid all taxes required to have been paid by them and any assessments received by them, except for any taxes or assessments the amount, applicability, or validity of which is currently being contested in good faith and for which appropriate reserves have been established in accordance with IFRS. There are no material tax deficiencies that have been asserted or assessed (or, to the Company's knowledge, proposed to be assessed) against the Company or any of its subsidiaries.
Based on the projected revenue composition of the Company for the fiscal year ending December 31, 2023 (with more than 75% of the Company's gross income expected to constitute active trade or business income), the Company does not expect to be classified as a "passive foreign investment company" ("PFIC") within the meaning of Section 1297 of the U.S. Internal Revenue Code of 1986, as amended (the "Code"), for U.S. federal income tax purposes for the taxable year ending December 31, 2023. The Company will use commercially reasonable efforts to avoid PFIC status in future taxable years.
The Company's U.S. Subsidiary, Solstice Surgical Inc., maintains a cost-plus intercompany services agreement with the Company pursuant to which the U.S. Subsidiary provides certain administrative, regulatory, and clinical support services to the Company in exchange for reimbursement of the U.S. Subsidiary's costs plus a 7.5% markup. Such intercompany services agreement has been prepared and is maintained in compliance with applicable transfer pricing rules, including Section 482 of the Code and the Treasury Regulations promulgated thereunder, and the OECD Transfer Pricing Guidelines for Multinational Enterprises and Tax Administrations.
For the avoidance of doubt, the standard rate of Irish withholding tax on dividends is 25%. However, under the Convention Between the Government of the United States of America and the Government of Ireland for the Avoidance of Double Taxation and the Prevention of Fiscal Evasion with Respect to Taxes on Income and Capital Gains (the "U.S.–Ireland Double Taxation Convention"), the rate of withholding tax on dividends paid by the Company to qualifying U.S. holders is reduced to 15%.
2(l). Deposit Agreement.
The Deposit Agreement, dated as of March 2, 2023, among the Company, Meridian Trust Company, N.A. (having its principal corporate trust office at 500 Ross Street, Pittsburgh, PA 15219; Attention: Thomas Crenna, Vice President, Depositary Receipts), as Depositary, and all holders and beneficial owners of ADSs issued thereunder, has been duly authorized by all necessary corporate action on the part of the Company and has been duly executed and delivered by the Company. The Deposit Agreement constitutes a legal, valid, and binding obligation of the Company, enforceable against the Company in accordance with its terms, except as may be limited by (i) bankruptcy, insolvency, reorganization, moratorium, examinership, or similar laws relating to or affecting the enforcement of creditors' rights generally, and (ii) general equitable principles (whether such enforceability is considered in a proceeding in equity or at law). Each ADS issued pursuant to the Deposit Agreement represents one (1) Ordinary Share, and the rights of holders and beneficial owners of ADSs are as set forth in the Deposit Agreement.
2(m). Internal Controls and Disclosure Controls.
The Company maintains a system of internal accounting controls sufficient to provide reasonable assurance that (i) transactions are executed in accordance with management's general or specific authorization, (ii) transactions are recorded as necessary to permit preparation of financial statements in conformity with IFRS and to maintain accountability for assets, (iii) access to assets is permitted only in accordance with management's general or specific authorization, and (iv) the recorded accountability for assets is compared with existing assets at reasonable intervals and appropriate action is taken with respect to any differences. The Company's internal control over financial reporting is effective and the Company is not aware of any material weaknesses in its internal control over financial reporting.
The Company has established and maintains disclosure controls and procedures (as such term is defined in Rule 13a-15(e) under the Exchange Act) that are designed to ensure that information required to be disclosed by the Company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized, and reported, within the time periods specified in the Commission's rules and forms, and is accumulated and communicated to the Company's management, including its principal executive officer and principal financial officer, as appropriate, to allow timely decisions regarding required disclosure.
2(n). Insurance.  The Company and its subsidiaries maintain insurance covering their respective properties, operations, personnel, and businesses, including business interruption insurance, in amounts and with deductibles and self-insured retentions that the Company believes are reasonable and adequate for the conduct of the business of the Company and its subsidiaries as described in the Prospectus.
Without limiting the foregoing, the Company maintains directors' and officers' liability insurance (the "D&O Policy") providing a primary layer of coverage in the amount of $20,000,000, underwritten by Ironclad Specialty Insurance Co. and placed through Ashford Wren & Co. (Attention: Lydia Carver, Senior Vice President). The D&O Policy was bound at pricing on March 2, 2023, and will become effective upon the Closing Date, with retroactive coverage for wrongful acts occurring on or after March 2, 2023. The Company and its subsidiaries are in compliance with the terms of all insurance policies to which they are a party or under which they are insured, and there are no claims pending under any such policies as to which coverage has been denied or disputed by the underwriters of such policies.
2(o). Compliance with Laws.
The Company and each of its subsidiaries are in compliance in all material respects with all applicable laws, statutes, rules, regulations, ordinances, orders, judgments, writs, and decrees of any governmental authority having jurisdiction over the Company, the U.S. Subsidiary, or any of their respective properties or assets, except where the failure to be in such compliance would not, individually or in the aggregate, have a Material Adverse Effect. Neither the Company nor any of its subsidiaries has received any written notice of any violation of any such law, statute, rule, regulation, ordinance, order, judgment, writ, or decree that would, individually or in the aggregate, have a Material Adverse Effect.
2(p). Related Party Transactions.
All transactions between or among the Company and any of its affiliates, officers, directors, or shareholders (or any family member or affiliate of any of the foregoing) are as disclosed in the Prospectus under the caption "Certain Relationships and Related Party Transactions," and all such transactions were entered into on terms no less favorable to the Company than would have been obtainable in a comparable arm's-length transaction with an unrelated third party.
2(q). Listing.  The ADSs have been approved for listing on the Nasdaq Global Market under the ticker symbol "SBDX," subject only to official notice of issuance. The Company has complied with all applicable requirements of the Nasdaq Stock Market LLC in connection with such listing.
2(r). FINRA Matters.
No FINRA-affiliated person holds any equity interests in the Company or has any other interest in or relationship with the Company that would require disclosure pursuant to FINRA Rule 5110 or any other applicable rule of FINRA, except as has been disclosed to FINRA. FINRA has issued a letter confirming that it has no objection to the underwriting terms and arrangements described in the Registration Statement and the Prospectus.
2(s). Lock-Up Agreements.
Each of the persons and entities listed on Schedule II hereto has executed and delivered to the Representative a Lock-Up Agreement substantially in the form attached hereto as Exhibit A (each, a "Lock-Up Agreement"), pursuant to which each such person or entity has agreed, for a period of 180 days from the date of the Prospectus (i.e., from March 2, 2023 through August 29, 2023), not to offer, sell, contract to sell, pledge, grant any option to purchase, make any short sale of, or otherwise dispose of, directly or indirectly, any Ordinary Shares, ADSs, or any securities convertible into or exercisable or exchangeable for Ordinary Shares or ADSs, or publicly disclose the intention to do any of the foregoing, without the prior written consent of the Representative. The Lock-Up Agreements cover an aggregate of 23,480,000 Ordinary Shares, representing approximately 83.9% of the 28,000,000 Ordinary Shares outstanding immediately prior to the consummation of the offering contemplated hereby. The locked-up persons and entities and their respective share holdings are as set forth on Schedule II hereto. To the Company's knowledge, each Lock-Up Agreement is in full force and effect and is a legal, valid, and binding obligation of the party thereto, enforceable in accordance with its terms.
2(t). Foreign Private Issuer.
The Company qualifies as a "foreign private issuer" as such term is defined in Rule 405 under the Act and Rule 3b-4 under the Exchange Act. The Company is eligible to use Form 20-F for its annual reports under the Exchange Act and Form 6-K for current reports under the Exchange Act.
2(u). Use of Proceeds.
The Company intends to use the net proceeds from the offering of the ADSs contemplated hereby as described in the Prospectus under the caption "Use of Proceeds." The net proceeds to the Company from the offering (assuming full exercise of the Overallotment Option) are estimated to be approximately $76,275,000, after deducting the total underwriting discount of approximately $5,525,000 and estimated offering expenses payable by the Company of approximately $3,200,000. The Company currently intends to allocate such net proceeds approximately as follows:
The foregoing allocation of net proceeds represents the Company's current intentions based upon its present plans and business conditions. The Company reserves the right to adjust the allocation of net proceeds as described in the Prospectus.
SECTION 3. PURCHASE, SALE AND DELIVERY OF ADSs.
On the basis of the representations, warranties, and agreements herein contained, and subject to the terms and conditions herein set forth, the Company agrees to issue and sell to each of the Underwriters, and each of the Underwriters agrees, severally and not jointly, to purchase from the Company, at the purchase price set forth in Section 1(a) hereof, the number of Firm ADSs set forth opposite such Underwriter's name in Schedule I hereto. Each Underwriter's obligation to purchase Firm ADSs shall be several and not joint; no Underwriter shall be responsible for the obligation of any other Underwriter to purchase Firm ADSs, except as provided in Section 12 hereof.
If the Overallotment Option is exercised, each Underwriter shall purchase, at the purchase price set forth in Section 1(b) hereof, the number of Option ADSs (subject to such adjustments as the Representative may determine to avoid fractional ADSs) that bears the same proportion to the total number of Option ADSs to be purchased pursuant to such exercise as the number of Firm ADSs to be purchased by such Underwriter bears to the total number of Firm ADSs. The Overallotment Option shall be exercised by delivery by the Representative to the Company of a written notice setting forth the aggregate number of Option ADSs to be purchased and the date on which the Option ADSs are to be delivered (each such date, an "Option Closing Date"). Such notice may be given at any time, and from time to time, within 30 days from the date of the Prospectus.
Certificates or book-entry positions representing the ADSs to be delivered hereunder shall be registered in such names and in such denominations as the Representative shall request in writing not later than two (2) full business days prior to the Closing Date or any Option Closing Date, as applicable. The ADSs shall be made available for checking and packaging by the Representative at such location as DTC shall designate not later than 1:00 p.m. (New York City time) on the business day preceding the Closing Date or any Option Closing Date, as applicable. Delivery of the ADSs shall be made through the facilities of DTC unless the Representative shall otherwise instruct.
The Company shall cause its registrar and transfer agent to deposit, or cause to be deposited, the Ordinary Shares underlying the ADSs with the Depositary (Meridian Trust Company, N.A.), or its custodian, in exchange for the issuance by the Depositary of the ADSs to be delivered hereunder. Such deposit shall be made in sufficient time to permit timely delivery of the ADSs on the Closing Date and each Option Closing Date, as applicable, through the facilities of DTC.
SECTION 4. OFFERING BY THE UNDERWRITERS.
The several Underwriters will offer the ADSs for sale to the public upon the terms set forth in the Prospectus. The ADSs shall be offered for sale to the public at the Public Offering Price of $11.0769 per ADS.
It is understood that the several Underwriters propose to offer the ADSs for sale to the public as set forth in the Prospectus. The Underwriters may from time to time increase or decrease the public offering price after the initial offering to such extent as they may determine. In addition, the Underwriters may allow concessions and reallowances to selected broker-dealers who are members of FINRA in the amounts and upon the terms set forth in the Prospectus.
Each Underwriter, severally and not jointly, represents and agrees that (i) it has not and will not use, authorize use of, refer to, or participate in the planning for use of, any Free Writing Prospectus, other than (A) any Free Writing Prospectus approved in advance in writing by the Company and the Representative, (B) the documents listed on Schedule III hereto (if any), or (C) any Free Writing Prospectus prepared by such Underwriter and approved in advance in writing by the Company, and (ii) it has complied and will comply with all applicable provisions of the Act, the Rules and Regulations, and the rules and regulations of FINRA in connection with the offering and sale of the ADSs as contemplated herein.
SECTION 5. COVENANTS OF THE COMPANY.
The Company covenants and agrees with each of the Underwriters as follows:
5(a). Amendments and Supplements.
The Company shall not, during such period as the Prospectus is required by law to be delivered (whether physically or through compliance with Rule 172 under the Act) in connection with the sale of the ADSs, file any amendment or supplement to the Registration Statement or the Prospectus, unless a copy thereof shall first have been submitted to the Representative a reasonable time prior to the filing thereof and the Representative shall not have objected thereto in good faith (such consent not to be unreasonably withheld, conditioned, or delayed).
5(b). Delivery of Copies.
The Company shall furnish to the Representative, without charge, as many copies of the Prospectus (and any amendments or supplements thereto) as the Representative may reasonably request for the purposes contemplated by the Act. The Company consents to the use of the Prospectus (and any amendments or supplements thereto) by the several Underwriters in connection with the offering and sale of the ADSs.
5(c). Blue Sky Compliance.
The Company shall cooperate with the Underwriters and underwriters' counsel in the qualification or registration of the ADSs for offer and sale under the securities or "blue sky" laws of such jurisdictions as the Representative may designate and shall continue such qualification or registration in effect so long as required for the distribution of the ADSs; provided, however, that the Company shall not be required to (i) qualify as a foreign corporation or other entity in any jurisdiction where it is not so qualified, (ii) take any action that would subject it to general service of process in any jurisdiction where it is not so subject, or (iii) subject itself to taxation in any jurisdiction where it is not so subject.
5(d). Earnings Statement.
The Company shall make generally available to its security holders and to the Representative, as soon as practicable, an earnings statement covering a period of at least twelve (12) months commencing after the effective date of the Registration Statement that satisfies the provisions of Section 11(a) of the Act and Rule 158 thereunder.
5(e). Use of Proceeds.
The Company shall apply the net proceeds from the sale of the ADSs in the manner described in the Prospectus under the caption "Use of Proceeds."
5(f). Restriction on Issuance of Securities.
For a period of 180 days after the date of the Prospectus (i.e., from March 2, 2023 through August 29, 2023) (the "Restricted Period"), the Company shall not, without the prior written consent of the Representative (which consent may be withheld in the sole discretion of the Representative), directly or indirectly, (i) issue, sell, offer to sell, contract to sell, or grant any option, right, or warrant to purchase, any Ordinary Shares, ADSs, or any securities convertible into or exercisable or exchangeable for Ordinary Shares or ADSs, (ii) file any registration statement under the Act with respect to any Ordinary Shares, ADSs, or any securities convertible into or exercisable or exchangeable for Ordinary Shares or ADSs, or (iii) enter into any swap or other agreement or any transaction that transfers, in whole or in part, directly or indirectly, the economic consequence of ownership of any Ordinary Shares, ADSs, or any securities convertible into or exercisable or exchangeable for Ordinary Shares or ADSs, whether any such swap or transaction described in clause (i), (ii), or (iii) above is to be settled by delivery of Ordinary Shares, ADSs, or such other securities, in cash, or otherwise.
The foregoing restrictions shall not apply to (A) the issuance by the Company of Ordinary Shares underlying the ADSs offered and sold hereunder (including the Option ADSs), (B) the issuance by the Company of Ordinary Shares, options to purchase Ordinary Shares, or other equity-based awards pursuant to the Company's equity incentive plans as in effect on the date hereof, as described in the Prospectus, and (C) the issuance by the Company of Ordinary Shares upon the exercise of options or other equity awards outstanding on the date hereof.
5(g). Listing.  The Company shall use its reasonable best efforts to effect and maintain the listing of the ADSs on the Nasdaq Global Market (or any successor trading market or quotation system of comparable standing).
5(h). DTC Eligibility.
The Company shall cooperate with the Representative and DTC to permit the ADSs to be eligible for clearance and settlement through the facilities of DTC, including, without limitation, compliance with all applicable DTC rules and regulations.
5(i). Reporting.  For so long as the Company is subject to the reporting requirements of Section 13 or 15(d) of the Exchange Act, the Company shall comply with its reporting obligations thereunder, including the timely filing of all annual reports on Form 20-F and current reports on Form 6-K.
SECTION 6. CONDITIONS TO THE OBLIGATIONS OF THE UNDERWRITERS.
The obligations of the several Underwriters to purchase and pay for the ADSs as provided herein shall be subject to the accuracy of the representations and warranties of the Company herein contained as of the date hereof, the Closing Date, and each Option Closing Date (if any), to the performance by the Company of its covenants and agreements herein contained, and to the following additional conditions:
6(a). Effectiveness of Registration Statement.
The Registration Statement on Form S-1 (File No. 333-268514) shall have been declared effective by the Commission and shall remain effective, and no stop order suspending the effectiveness of the Registration Statement shall have been issued by the Commission and no proceeding for that purpose shall have been initiated or threatened by the Commission. Any request by the Commission for additional information to be included in the Registration Statement or the Prospectus, or otherwise, shall have been complied with to the reasonable satisfaction of the Representative.
6(b). No Material Adverse Change.
Since the date of the most recent financial statements included in the Registration Statement and the Prospectus (December 31, 2022), there shall not have occurred any Material Adverse Effect on the business, properties, assets, liabilities, operations, financial condition, or results of operations of the Company and its subsidiaries, taken as a whole, except as set forth in or contemplated by the Registration Statement and the Prospectus, and no event shall have occurred or condition shall exist that would reasonably be expected to result in a Material Adverse Effect.
6(c). Opinion of Issuer's Counsel.
The Representative shall have received the favorable written opinion and negative assurance (10b-5) letter of Calderwood & Harkness LLP, counsel to the Company, addressed to the Underwriters, dated the Closing Date (or the applicable Option Closing Date), in form and substance satisfactory to the Representative and to Pellwick Raine LLP, counsel to the Underwriters, covering, among other things:
(i) The Company is a private company limited by shares duly incorporated and validly existing under the laws of Ireland, with full corporate power and authority to own, lease, and operate its properties and to conduct its business as described in the Prospectus;
(ii) The Ordinary Shares underlying the ADSs to be issued and sold hereunder have been duly authorized and, when issued and delivered to the Depositary against payment therefor as provided in this Agreement, will be validly issued, fully paid, and non-assessable;
(iii) This Agreement has been duly authorized, executed, and delivered by the Company and constitutes a legal, valid, and binding obligation of the Company, enforceable against the Company in accordance with its terms, subject to customary exceptions;
(iv) The Deposit Agreement has been duly authorized, executed, and delivered by the Company and constitutes a legal, valid, and binding obligation of the Company, enforceable against the Company in accordance with its terms, subject to customary exceptions;
(v) The Registration Rights Agreement has been duly authorized, executed, and delivered by the Company and constitutes a legal, valid, and binding obligation of the Company, enforceable against the Company in accordance with its terms, subject to customary exceptions;
(vi) The Registration Statement has been declared effective under the Act; to the knowledge of such counsel, no stop order suspending the effectiveness thereof has been issued and no proceeding for that purpose has been initiated or threatened by the Commission;
(vii) The Registration Statement and the Prospectus (other than the financial statements and supporting schedules included therein, as to which such counsel need not express any opinion) comply as to form in all material respects with the applicable requirements of the Act and the Rules and Regulations;
(viii) Negative assurance to the effect that nothing has come to such counsel's attention that causes it to believe that (A) the Registration Statement, at the time it became effective, contained any untrue statement of a material fact or omitted to state any material fact required to be stated therein or necessary to make the statements therein not misleading, or (B) the Prospectus, as of its date and as of the Closing Date (or the applicable Option Closing Date), contained or contains any untrue statement of a material fact or omitted or omits to state any material fact necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading (in each case, other than the financial statements and supporting schedules included therein, as to which such counsel need not provide any negative assurance); and
(ix) Such other matters as the Representative or Pellwick Raine LLP may reasonably request.
Such opinion and negative assurance letter shall be signed by Theodore Langston, Responsible Partner at Calderwood & Harkness LLP.
6(d). Opinion of Underwriters' Counsel.
The Representative shall have received the favorable written opinion of Pellwick Raine LLP (Harrison Blake, Partner), counsel to the Underwriters, dated the Closing Date (or the applicable Option Closing Date), with respect to the issuance and sale of the ADSs, the Registration Statement, the Prospectus, and such other matters as the Representative may reasonably request. In rendering such opinion, Pellwick Raine LLP may rely as to matters of Irish law upon the opinion of Calderwood & Harkness LLP (or other Irish counsel satisfactory to the Representative) and as to matters of fact upon certificates of officers of the Company and public officials.
6(e). Officers' Certificate.
The Representative shall have received a certificate, dated the Closing Date (or the applicable Option Closing Date), signed by Dr. Cormac Tierney, Chief Executive Officer of the Company, and Ronan McBride, Chief Financial Officer of the Company, to the effect that:
(i) The representations and warranties of the Company set forth in Section 2 of this Agreement are true and correct in all material respects as of the Closing Date (or the applicable Option Closing Date) with the same force and effect as if made on and as of such date;
(ii) The Company has performed and complied with all agreements, covenants, and conditions required by this Agreement to be performed or complied with by it at or prior to the Closing Date (or the applicable Option Closing Date);
(iii) No stop order suspending the effectiveness of the Registration Statement has been issued by the Commission and no proceeding for that purpose has been initiated or, to the knowledge of the signatories, threatened by the Commission;
(iv) Since December 31, 2022, there has been no Material Adverse Effect on the business, properties, assets, liabilities, operations, financial condition, or results of operations of the Company and its subsidiaries, taken as a whole, except as set forth in or contemplated by the Registration Statement and the Prospectus; and
(v) Such other matters as the Representative may reasonably request.
6(f). Secretary's Certificate.
The Representative shall have received a certificate of the Secretary (or equivalent officer) of the Company, dated the Closing Date, attaching and certifying as true, correct, and complete copies of:
(i) Resolutions duly adopted by the board of directors of the Company authorizing the initial public offering of the ADSs, the execution, delivery, and performance of this Agreement, the Deposit Agreement, and the Registration Rights Agreement, and the issuance of up to 7,666,667 Ordinary Shares underlying the ADSs (including the Ordinary Shares underlying the Option ADSs);
(ii) Resolutions duly adopted by the shareholders of the Company amending the authorized share capital of the Company to 100,000,000 Ordinary Shares at a nominal value of €0.01 per share and authorizing the transactions contemplated by this Agreement;
(iii) An incumbency certificate identifying the name, title, and specimen signature of each officer and director of the Company authorized to execute the Transaction Documents, including Dr. Cormac Tierney (Chief Executive Officer), Dr. Siobhán Kelleher (Chief Technology Officer), Ronan McBride (Chief Financial Officer), Fiona Drennan (General Counsel and Company Secretary), and Declan Whitfield (Chairman of the Board of Directors); and
(iv) The memorandum and articles of association of the Company as currently in effect.
6(g). Comfort Letters.
The Representative shall have received from Calderwood & Associates LLP (Patricia Yuen, Engagement Partner), the Company's independent registered public accounting firm, comfort letters in form and substance satisfactory

UNDERWRITING AGREEMENT

UNDERWRITING AGREEMENT

SECTION 2. REPRESENTATIONS AND WARRANTIES OF THE COMPANY.

SECTION 4. OFFERING BY THE UNDERWRITERS.

SECTION 5. COVENANTS OF THE COMPANY.

SECTION 6. CONDITIONS TO THE OBLIGATIONS OF THE UNDERWRITERS.

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