1037-00001 · Client 1037 · Closing

opinion-of-issuers-counsel.docx DOCUMENT Capital Markets

3 / 12 ← → ✕

Contract analysis Extract to table

CONFIDENTIAL

CALDERWOOD & HARKNESS LLP 425 Lexington Avenue New York, NY 10174

Telephone: (212) 558-4000 Facsimile: (212) 558-3588 www.calderwoodharkness.com

March 21, 2023

Keystone Mercer & Co., LLC as Representative of the Several Underwriters 280 Park Avenue, 14th Floor New York, NY 10017

Copy to:

Ridgeline Capital Markets, Inc. 100 Summer Street, Suite 2400 Boston, MA 02110

Broadleaf Partners LLC 600 Travis Street, Suite 3100 Houston, TX 77002

Ladies and Gentlemen:

Re: Initial Public Offering of American Depositary Shares of Solstice Biomedical Devices Limited

We have acted as United States counsel to Solstice Biomedical Devices Limited, a private company limited by shares incorporated in Ireland under the Companies Act 2014 (CRO No. 587412) (the "Company"), in connection with the initial public offering (the "Offering") of American Depositary Shares ("ADSs") of the Company. This opinion letter is delivered to you pursuant to Section 5(e) of the Underwriting Agreement dated March 2, 2023 (the "Underwriting Agreement") among the Company and Keystone Mercer & Co., LLC, as representative (the "Representative") of the several underwriters named therein (collectively, the "Underwriters"), as a condition to the obligations of the Underwriters at the closing of the Offering occurring on the date hereof.

The Offering consists of 6,666,667 firm ADSs (the "Firm ADSs") and up to 1,000,000 additional ADSs (the "Option ADSs" and, together with the Firm ADSs, the "Offered ADSs") issuable upon exercise of the overallotment option granted by the Company to the Underwriters pursuant to Section 2(b) of the Underwriting Agreement. Each ADS represents one (1) ordinary share, nominal value €0.01 per share, of the Company (the "Ordinary Shares"). The Ordinary Shares underlying the Firm ADSs and, if applicable, the Option ADSs are collectively referred to herein as the "Underlying Shares." The public offering price of the ADSs is $11.0769 per ADS, resulting in aggregate gross proceeds to the Company of $73,846,089.23 for the Firm ADSs and up to $85,000,006.90 assuming full exercise of the overallotment option (approximately $85,000,000). The ADSs have been assigned CUSIP number 83472R 109 and are listed on the Nasdaq Global Market under the ticker symbol "SBDX."

I. DEFINITIONS

As used in this opinion letter, the following terms have the meanings set forth below:

"ADSs" means American Depositary Shares, each representing one (1) Ordinary Share, issued pursuant to the Deposit Agreement.

"Company" means Solstice Biomedical Devices Limited, a private company limited by shares incorporated in Ireland under the Companies Act 2014 (CRO No. 587412), with its registered office at Unit 7, Lakeview Technology Campus, Parkmore East, Galway, H91 XK72, Ireland.

"Deposit Agreement" means the Deposit Agreement dated March 2, 2023, among the Company, Meridian Trust Company, N.A. ("Meridian Trust"), as depositary, and all holders and beneficial owners of ADSs issued thereunder from time to time, as such agreement may be amended, supplemented, or otherwise modified in accordance with its terms.

"Effective Date" means February 28, 2023, the date on which the Registration Statement was declared effective by the United States Securities and Exchange Commission (the "SEC").

"Exchange Act" means the Securities Exchange Act of 1934, as amended, and the rules and regulations of the SEC promulgated thereunder.

"Lock-Up Agreements" means the lock-up agreements, in the form attached as Exhibit A to the Underwriting Agreement, executed by certain directors, executive officers, and holders of one percent (1%) or more of the pre-IPO Ordinary Shares in favor of Keystone Mercer & Co., LLC, as representative of the Underwriters, pursuant to which such persons have agreed to a 180-day restriction period commencing on March 2, 2023 (the Pricing Date) and expiring on August 29, 2023, subject to certain customary exceptions set forth therein.

"Ordinary Shares" means ordinary shares of the Company, nominal value €0.01 per share.

"Pricing Date" means March 2, 2023.

"Prospectus" means the final prospectus dated March 2, 2023, forming part of the Registration Statement, as filed with the SEC pursuant to Rule 424(b)(4) under the Securities Act on March 3, 2023, including all documents incorporated by reference therein.

"Registration Rights Agreement" means the Registration Rights Agreement dated 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., as such agreement may be amended, supplemented, or otherwise modified in accordance with its terms.

"Registration Statement" means the Registration Statement on Form S-1 (File No. 333-268514) filed by the Company with the SEC under the Securities Act, including all amendments thereto (including all pre-effective and post-effective amendments), all exhibits and schedules thereto, and the Prospectus included therein, as declared effective by the SEC on the Effective Date.

"Securities Act" means the Securities Act of 1933, as amended, and the rules and regulations of the SEC promulgated thereunder.

"Transaction Documents" means, collectively, the Underwriting Agreement, the Deposit Agreement, and the Registration Rights Agreement.

"Underwriting Agreement" has the meaning assigned to it in the introductory paragraph of this opinion letter.

II. SCOPE OF EXAMINATION; DOCUMENTS REVIEWED

In connection with rendering the opinions set forth herein, we have examined originals or copies (certified or otherwise identified to our satisfaction) of the following documents, certificates, records, and instruments:

1. The Registration Statement on Form S-1 (File No. 333-268514), including all amendments thereto (Amendment Nos. 1 through 4) and all exhibits and schedules thereto, as declared effective by the SEC on February 28, 2023;

2. The Prospectus dated March 2, 2023, as filed with the SEC pursuant to Rule 424(b)(4) under the Securities Act;

3. The executed Underwriting Agreement dated March 2, 2023, among the Company and the Underwriters;

4. The executed Deposit Agreement dated March 2, 2023, among the Company, Meridian Trust Company, N.A., as depositary, and all holders and beneficial owners of ADSs from time to time;

5. The executed Registration Rights Agreement dated 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.;

6. Forms of Lock-Up Agreements, in the form attached as Exhibit A to the Underwriting Agreement, executed by the directors, executive officers, and holders of one percent (1%) or more of the pre-IPO Ordinary Shares of the Company, covering in the aggregate 23,480,000 Ordinary Shares, representing approximately 83.9% of the total pre-IPO Ordinary Shares outstanding;

7. The memorandum and articles of association of the Company, as amended and restated, including the special resolution adopted by the shareholders of the Company on February 15, 2023, approving the amendment to the authorized share capital of the Company to 100,000,000 Ordinary Shares, nominal value €0.01 each;

8. Resolutions of the board of directors of the Company, adopted at meetings duly convened and held on January 24, 2023 and March 1, 2023, authorizing, among other things, the Offering, the execution and delivery of each of the Transaction Documents, and the issuance of up to 7,666,667 Ordinary Shares underlying the ADSs (consisting of 6,666,667 Ordinary Shares underlying the Firm ADSs and 1,000,000 Ordinary Shares underlying the Option ADSs);

9. Resolutions of the shareholders of the Company, adopted at an extraordinary general meeting duly convened and held on February 15, 2023, approving the amendment to the authorized share capital of the Company as described in item 7 above and granting authority to the board of directors to allot and issue Ordinary Shares in connection with the Offering, including the disapplication of statutory preemption rights under Part 4 of the Irish Companies Act 2014;

10. The certificate of incorporation of the Company (dated April 17, 2017) and related filings with the Irish Companies Registration Office ("CRO"), including the annual returns filed through the date hereof, evidencing the Company's incorporation and continued registration under CRO No. 587412;

11. An Officers' Certificate of the Company dated March 21, 2023, executed by Dr. Cormac Tierney, Chief Executive Officer, and Ronan McBride, Chief Financial Officer (the "Officers' Certificate"), certifying as to certain factual matters relevant to the opinions expressed herein;

12. A Secretary's Certificate of the Company dated March 21, 2023, executed by Fiona Callaghan, Company Secretary, certifying as to the incumbency of the officers and directors of the Company, attaching true and complete copies of the board and shareholder resolutions described in items 8 and 9 above, and certifying the completeness and accuracy of the constitutional documents of the Company;

13. A certificate of good standing (or status) with respect to the Company issued by the Irish CRO, dated March 16, 2023;

14. A certificate of incorporation issued by the Secretary of State of the State of Delaware and a certificate of good standing issued by the Secretary of State of the State of Delaware, each with respect to Solstice Surgical Inc., a Delaware corporation (EIN 87-4231568), the Company's wholly owned U.S. subsidiary; and

15. Such other documents, certificates, records, and instruments as we have deemed necessary or appropriate for purposes of rendering the opinions expressed herein.

In our examination, we have assumed the genuineness of all signatures, the legal capacity of all natural persons, the authenticity of all documents submitted to us as originals, the conformity to the originals of all documents submitted to us as copies, and the accuracy and completeness of all documents and records that we have reviewed. We have relied, without independent verification, upon certificates and other assurances of officers and other representatives of the Company and upon certificates and statements of public officials as to matters of fact.

III. ASSUMPTIONS

In rendering the opinions expressed herein, we have assumed, in addition to the assumptions set forth elsewhere in this opinion letter, the following:

(a) All signatures on all documents examined by us are genuine, and all documents submitted to us as originals are authentic and complete. All documents submitted to us as copies conform to the originals thereof, and all such originals are authentic and complete.

(b) Each natural person executing any document examined by us had, at the time of such execution, full legal capacity to do so.

(c) Each of the Transaction Documents has been duly authorized, executed, and delivered by each party thereto other than the Company, including by the Underwriters (Keystone Mercer & Co., LLC, Ridgeline Capital Markets, Inc., and Broadleaf Partners LLC), by Meridian Trust Company, N.A. (as depositary under the Deposit Agreement), and by each of Greystone Ventures Fund III, L.P., Pinnacle Health Innovation Fund, L.P., and Elkridge Growth Partners II, L.P. (as parties to the Registration Rights Agreement).

(d) All certificates, representations, and statements of officers of the Company and of public officials that we have relied upon in connection with this opinion are accurate and complete in all material respects as of the date hereof.

(e) Each of the Underwriters is duly organized, validly existing, and in good standing under the laws of its respective jurisdiction of organization: Keystone Mercer & Co., LLC is a limited liability company duly organized under the laws of the State of Delaware; Ridgeline Capital Markets, Inc. is a corporation duly incorporated under the laws of the State of Delaware; and Broadleaf Partners LLC is a limited liability company duly organized under the laws of the State of Delaware.

(f) Meridian Trust Company, N.A. is duly organized and validly existing as a national banking association under the laws of the United States and has the requisite power and authority to enter into and perform its obligations under the Deposit Agreement.

(g) All consents, approvals, authorizations, orders, registrations, qualifications, licenses, and permits required to be obtained by persons and entities other than the Company in connection with the execution, delivery, and performance of the Transaction Documents and the consummation of the transactions contemplated thereby have been duly obtained and are in full force and effect as of the date hereof.

(h) The choice of governing law provisions contained in the Transaction Documents are valid and enforceable, and the courts of the relevant jurisdictions would give effect thereto.

(i) No assumption or opinion is expressed with respect to the laws of Ireland or any other jurisdiction other than the federal laws of the United States, the laws of the State of New York, and the laws of the State of Delaware. Our opinions relating to matters governed by the laws of Ireland are based solely on our review of and reliance upon the opinion of Ashford Hale & Partners, Solicitors (Dublin), as Irish counsel to the Company, delivered at the closing on the date hereof. We express no independent opinion on such matters.

IV. QUALIFICATIONS AND LIMITATIONS

The opinions expressed herein are subject to the following qualifications and limitations:

A. Jurisdictional Limitation. The opinions expressed in this letter are limited in all respects to (a) the federal laws of the United States of America, (b) the laws of the State of New York, and (c) the laws of the State of Delaware (which is the governing law of the Underwriting Agreement and the Registration Rights Agreement). We express no opinion with respect to the laws of Ireland or any other jurisdiction, and we note that the Company is incorporated under the laws of Ireland and that certain matters relating to the Company's incorporation, corporate status, authorized share capital, validity and issuance of Ordinary Shares, and constitutional documents are governed by the Irish Companies Act 2014 and other laws of Ireland. With respect to such matters, we have relied solely upon the opinion of Ashford Hale & Partners, Solicitors, delivered at the closing on the date hereof, and the certificates and confirmations of the Irish Companies Registration Office referred to in Section II above. Our opinions regarding the valid issuance, full payment, and nonassessability of the Ordinary Shares are qualified by and subject to such reliance.

B. Bankruptcy and Insolvency Qualification. The opinions expressed herein regarding the enforceability of the Transaction Documents and the obligations of the Company thereunder are subject to and qualified by (a) applicable bankruptcy, insolvency, reorganization, receivership, moratorium, fraudulent conveyance, fraudulent transfer, preference, and other similar laws relating to or affecting the enforcement of creditors' rights generally (including, without limitation, the United States Bankruptcy Code, Title 11, United States Code), and (b) general principles of equity, including principles of commercial reasonableness, good faith, and fair dealing (regardless of whether enforcement is sought in a proceeding at law or in equity), and the discretion of the court before which any proceeding therefor may be brought. We express no opinion as to (i) the availability of any particular remedy, including specific performance, injunctive relief, or any other equitable remedy, upon any breach of any Transaction Document, or (ii) the enforceability of any provision of any Transaction Document that purports to waive broadly or limit any rights, defenses, or counterclaims.

C. Securities Act Qualification. Except as specifically set forth in Opinions 7 and 10 below and in the negative assurance statement set forth in Section VI, we express no opinion that the Registration Statement or the Prospectus complies in all respects with the requirements of the Securities Act or the rules and regulations of the SEC promulgated thereunder, including Regulation S-K, Regulation S-X, and Regulation C. The negative assurance provided in Section VI is furnished in accordance with customary practice for opinions delivered in connection with registered offerings of securities and is subject to the limitations and exclusions stated therein.

D. No Opinion on Tax Matters. We do not express any opinion with respect to any federal, state, local, or foreign tax consequences arising from or relating to the Offering, the issuance of the Ordinary Shares or the ADSs, or any other transaction contemplated by the Transaction Documents. Tax consequences related to the Company and its shareholders, including the Company's status or potential status as a "passive foreign investment company" (PFIC) within the meaning of Section 1297 of the Internal Revenue Code of 1986, as amended, Irish withholding tax, and related matters, are addressed separately in the tax memorandum prepared by Sylvia Hartwell, Partner, Tax Department, Calderwood & Harkness LLP, dated February 10, 2023, a copy of which has been furnished to the Underwriters.

E. No Opinion on FDA Regulatory Matters. We do not express any opinion with respect to the regulatory status of any product of the Company or any of its subsidiaries under the Federal Food, Drug, and Cosmetic Act, as amended, or any regulations of the United States Food and Drug Administration (the "FDA"). Without limiting the generality of the foregoing, we express no opinion regarding the status, validity, or effect of FDA 510(k) clearance K211847 for the Company's NeuroPath™ neurovascular access system or Investigational Device Exemption (IDE) G220035 for the Company's OrthoSync™ spinal fixation platform, or the Company's compliance with FDA requirements generally.

F. Cutoff Date. This opinion letter speaks only as of the date hereof. We assume no obligation, and expressly disclaim any obligation, to update or supplement this opinion letter to reflect any facts or circumstances that may hereafter come to our attention or any changes in applicable law (whether by legislative action, judicial decision, or otherwise) that may hereafter occur, regardless of whether any such facts, circumstances, or changes may affect the opinions expressed herein.

V. OPINIONS

Based upon and subject to the foregoing, and subject to the assumptions, qualifications, and limitations set forth herein, we are of the opinion that:

Opinion 1 — Due Organization and Existence of the Company. Based solely on our review of the certificate of incorporation issued by the Irish Companies Registration Office, the certificate of good standing (status) issued by the Irish CRO dated March 16, 2023, and the Officers' Certificate dated March 21, 2023, and in reliance upon the opinion of Ashford Hale & Partners, Solicitors, as Irish counsel to the Company, the Company has been duly incorporated and is validly existing as a private company limited by shares under the laws of Ireland, CRO No. 587412, and has not been struck off the register or dissolved.

Opinion 2 — Due Organization and Existence of the U.S. Subsidiary. Solstice Surgical Inc. (EIN 87-4231568) is a corporation duly incorporated, validly existing, and in good standing under the laws of the State of Delaware, based on our review of the certificate of incorporation filed with the Secretary of State of the State of Delaware and the certificate of good standing issued by the Secretary of State of the State of Delaware as of a recent date.

Opinion 3 — Corporate Power and Authority. The Company has the requisite corporate power and authority under its memorandum and articles of association, as amended and restated, and under applicable law (insofar as we opine thereon), to execute and deliver each of the Transaction Documents (namely, the Underwriting Agreement, the Deposit Agreement, and the Registration Rights Agreement), to perform its obligations thereunder, and to consummate the transactions contemplated thereby, including, without limitation, the issuance and sale of the Ordinary Shares underlying the Firm ADSs and the Option ADSs.

Opinion 4 — Due Authorization. The execution, delivery, and performance by the Company of each of the Transaction Documents, and the issuance and sale by the Company of up to 7,666,667 Ordinary Shares (consisting of 6,666,667 Ordinary Shares underlying the Firm ADSs and 1,000,000 Ordinary Shares underlying the Option ADSs), have been duly authorized by all necessary corporate action on the part of the Company, including the adoption of resolutions by the board of directors of the Company at duly convened and held meetings on January 24, 2023 and March 1, 2023, and the adoption of resolutions by the shareholders of the Company at a duly convened and held extraordinary general meeting on February 15, 2023 (approving, among other things, the amendment to the authorized share capital and the disapplication of statutory preemption rights). Such resolutions have not been rescinded, amended, or modified and remain in full force and effect as of the date hereof.

Opinion 5 — Valid Issuance of Ordinary Shares. The Ordinary Shares underlying the ADSs, when issued and delivered by the Company against payment therefor in accordance with the terms and conditions of the Underwriting Agreement and deposited with Meridian Trust Company, N.A., as depositary, in accordance with the terms and conditions of the Deposit Agreement, will be validly issued, fully paid, and nonassessable (to the extent the concept of "nonassessability" is applicable under Irish law, and with reliance on the opinion of Ashford Hale & Partners, Solicitors, as Irish counsel to the Company, with respect to such matters under Irish law). Upon issuance of all Underlying Shares (assuming full exercise of the overallotment option), the total number of issued and outstanding Ordinary Shares of the Company will be 35,666,667, which does not exceed the authorized share capital of 100,000,000 Ordinary Shares, nominal value €0.01 each. Accordingly, sufficient authorized but unissued Ordinary Shares exist for the issuance of all Underlying Shares.

Opinion 6 — Enforceability of Transaction Documents. Each of the Transaction Documents has been duly executed and delivered by the Company and constitutes the legal, valid, and binding obligation of the Company, enforceable against the Company in accordance with its terms, except as the enforceability thereof may be limited by (a) applicable bankruptcy, insolvency, reorganization, moratorium, fraudulent conveyance, fraudulent transfer, and similar laws affecting creditors' rights generally, and (b) general principles of equity (regardless of whether enforcement is sought in a proceeding at law or in equity), as more fully described in Section IV(B) above. We note that the Underwriting Agreement is governed by the laws of the State of Delaware, and the Registration Rights Agreement is governed by the laws of the State of Delaware. The Deposit Agreement is governed by the laws of the State of New York.

Opinion 7 — Registration Statement and Prospectus. The Registration Statement on Form S-1 (File No. 333-268514) has been filed with the SEC and declared effective by the SEC as of February 28, 2023. As of the date hereof, no stop order suspending the effectiveness of the Registration Statement has been issued by the SEC, and, to our knowledge, no proceedings for that purpose have been instituted or are threatened by the SEC. The ADSs (and the Ordinary Shares represented thereby) have been registered under the Securities Act pursuant to the Registration Statement.

Opinion 8 — No Conflicts. The execution, delivery, and performance by the Company of each of the Transaction Documents, the issuance and sale of the Ordinary Shares, and the issuance of the ADSs by Meridian Trust (to the extent the Company's actions are concerned), do not and will not:

(a) violate, conflict with, or result in a breach or default under any provision of the memorandum and articles of association of the Company, as currently in effect;

(b) to our knowledge, violate any federal statute, rule, or regulation of the United States or any statute, rule, or regulation of the State of New York applicable to the Company; or

(c) result in a violation of any order, judgment, injunction, award, or decree of any court, arbitrator, or governmental or regulatory authority known to us to be binding upon or applicable to the Company or any of its properties or assets.

We note that the foregoing opinion does not address the laws of Ireland or any other jurisdiction other than the federal laws of the United States and the laws of the State of New York, and our opinion with respect to the Company's memorandum and articles of association is based on our review of the English-language text thereof as certified by the Secretary's Certificate.

Opinion 9 — No Consents Required (Other Than Those Obtained). No consent, approval, authorization, order, registration, or qualification of or with any federal or New York State court, governmental agency, or regulatory body is required for the execution and delivery by the Company of the Transaction Documents, or for the issuance and sale of the Ordinary Shares and the ADSs as contemplated by the Transaction Documents, except for:

(a) the declaration of effectiveness of the Registration Statement by the SEC under the Securities Act, which was obtained on February 28, 2023;

(b) the filing of the Prospectus with the SEC pursuant to Rule 424(b) under the Securities Act, which was made on March 3, 2023;

(c) the approval of the listing of the ADSs on the Nasdaq Global Market under the ticker symbol "SBDX," which has been obtained;

(d) the indication by the Financial Industry Regulatory Authority, Inc. ("FINRA") that it has no objection to the proposed underwriting terms and arrangements, which has been received; and

(e) such consents, approvals, authorizations, registrations, or qualifications as may be required under state securities or "Blue Sky" laws in connection with the purchase and distribution of the ADSs by the Underwriters, as to which we express no opinion.

Opinion 10 — Exchange Act Registration. The ADSs have been duly registered by the Company under Section 12(b) of the Exchange Act and have been approved for listing on the Nasdaq Global Market under the ticker symbol "SBDX." The Registration Statement on Form 8-A (File No. 001-41389), registering the ADSs under the Exchange Act, has been filed with the SEC and has become effective.

Opinion 11 — Investment Company Act. Based on our review of the Company's business, assets, and operations as described in the Registration Statement and the Prospectus, and in reliance upon the representations contained in the Officers' Certificate, the Company is not, and after giving effect to the Offering and the application of the net proceeds thereof as described in the Prospectus under the heading "Use of Proceeds," will not be, required to register as an "investment company" within the meaning of the Investment Company Act of 1940, as amended (the "Investment Company Act"), and the rules and regulations of the SEC promulgated thereunder.

VI. NEGATIVE ASSURANCE (10b-5 STATEMENT)

In addition to, and not in lieu of, the opinions set forth in Section V above, we advise you as follows:

We have participated in the preparation of the Registration Statement and the Prospectus and have participated in conferences and discussions with officers and other representatives of the Company (including Dr. Cormac Tierney, Chief Executive Officer, Ronan McBride, Chief Financial Officer, and Dr. Siobhán Keane, Vice President of Regulatory Affairs), representatives of Calderwood & Associates LLP (the Company's independent registered public accounting firm, including Patricia Yuen, engagement partner), representatives of the Underwriters, and representatives of Pellwick Raine LLP (counsel to the Underwriters, including Harrison Blake, Partner), at which the contents of the Registration Statement and the Prospectus and related matters were discussed. We have also reviewed the documents listed in Section II above. We have not, however, independently verified the accuracy, completeness, or fairness of the statements contained in the Registration Statement or the Prospectus (or any amendment or supplement thereto).

Based upon and subject to the foregoing (but without independent verification of any of the facts, data, representations, or information contained therein), and subject to the assumptions, qualifications, and limitations set forth in this opinion letter:

(i) Nothing has come to our attention that causes us to believe that the Registration Statement (File No. 333-268514), at the time it became effective on February 28, 2023, contained an untrue statement of a material fact or omitted to state a material fact required to be stated therein or necessary to make the statements therein not misleading.

(ii) Nothing has come to our attention that causes us to believe that the Prospectus, as of its date (March 2, 2023), or as of the date hereof (March 21, 2023), contained or contains an untrue statement of a material fact or omitted or omits 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.

Notwithstanding the foregoing, the negative assurance statements set forth in this Section VI do not extend to, and we express no belief with respect to:

(a) the financial statements of the Company and the related notes and schedules thereto included in or incorporated by reference into the Registration Statement or the Prospectus, which have been audited by Calderwood & Associates LLP, as set forth in their report included therein;

(b) any financial data or other financial information derived from the audited or unaudited financial statements of the Company or from the accounting records of the Company; or

The statements set forth in this Section VI are provided in accordance with customary practice in connection with opinions delivered by issuer's counsel in registered public offerings of securities and should not be construed as an independent investigation or verification of the facts, data, or information contained in the Registration Statement or the Prospectus. Our participation in the preparation of the Registration Statement and the Prospectus was limited to matters of a legal nature, and we have not participated in the preparation of, and are not in a position to express any view with respect to, the financial statements, financial data, or statistical data contained therein.

VII. RELIANCE AND BENEFIT

This opinion letter is furnished solely for the benefit of the addressees hereof — namely, Keystone Mercer & Co., LLC, as Representative of the Several Underwriters, Ridgeline Capital Markets, Inc., and Broadleaf Partners LLC (collectively, the "Underwriters") — in connection with the Transaction Documents and the transactions contemplated thereby, and may not be relied upon by any other person or entity, or for any other purpose, without our prior written consent in each instance.

This opinion letter may not be quoted in whole or in part, summarized, paraphrased, or otherwise referred to in any public document, filing, or statement, or otherwise furnished to any other person or entity, without our prior written consent, except (a) as may be required by applicable law or regulation, (b) as may be required in connection with any regulatory examination or proceeding, (c) as an exhibit to the Registration Statement, or (d) in connection with the enforcement of rights under the Transaction Documents, in each case to the extent required.

Notwithstanding the foregoing, Pellwick Raine LLP, as counsel to the Underwriters, may rely on this opinion letter in connection with any opinion or negative assurance letter delivered by Pellwick Raine LLP to the Underwriters in connection with the Offering and the Transaction Documents, to the same extent as if this opinion letter were addressed directly to Pellwick Raine LLP.

VIII. GENERAL PROVISIONS

This opinion letter is limited to the specific legal matters expressly addressed herein, and no opinion is to be implied or inferred beyond the matters expressly stated. We have not been asked to, and do not, opine on any matter not expressly set forth in this opinion letter.

We have not been asked to, and do not, express any opinion on any matter governed by the laws of Ireland. With respect to matters of Irish law, including without limitation the due incorporation and valid existence of the Company under the Irish Companies Act 2014, the Company's authorized and issued share capital, the validity and enforceability of the Company's memorandum and articles of association, and the valid issuance of Ordinary Shares under Irish law, we have relied solely upon the opinion of Ashford Hale & Partners, Solicitors (Dublin), delivered at the closing on the date hereof.

We express no opinion herein as to any matter of fact, and the opinions expressed herein are based solely on facts as they exist on the date hereof as reflected in the documents and certificates we have reviewed.

We assume no obligation to advise you, or any other person or entity, of any changes in applicable law or any changes in fact or circumstances that may occur or come to our attention after the date hereof, whether or not such changes may affect the opinions expressed herein. This opinion letter is not to be construed as a guarantee, warranty, or prediction of the outcome of any legal proceeding or dispute.

This opinion letter is governed by, and shall be construed and interpreted in accordance with, the laws of the State of New York, including the applicable provisions of the New York Rules of Professional Conduct and ABA/ABCNY legal opinion guidelines. The opinions expressed herein are rendered as of the date hereof and are based on the law in effect on the date hereof.

We trust that the foregoing is sufficient for your purposes. Should you have any questions regarding this opinion letter, please do not hesitate to contact the undersigned at (212) 558-4217 or at tlangston@calderwoodharkness.com.

Very truly yours,

CALDERWOOD & HARKNESS LLP

By: ________

Theodore Langston Partner, Capital Markets

CLOSING DELIVERABLES

This opinion letter is delivered together with, and should be read in conjunction with, the following closing deliverables referenced in the Closing Checklist attached as Schedule 1 to the Underwriting Agreement:

1. Officers' Certificate of the Company dated March 21, 2023, executed by Dr. Cormac Tierney, Chief Executive Officer, and Ronan McBride, Chief Financial Officer, certifying as to the accuracy of representations and warranties and the satisfaction of conditions to closing;

2. Secretary's Certificate of the Company dated March 21, 2023, executed by Fiona Callaghan, Company Secretary, attaching certified copies of the board of directors resolutions (January 24, 2023 and March 1, 2023), shareholder resolutions (February 15, 2023), incumbency certificates for the officers and directors of the Company, and the memorandum and articles of association of the Company (as amended and restated);

3. Comfort Letter of Calderwood & Associates LLP dated March 21, 2023, delivered by Patricia Yuen, engagement partner, in accordance with Statement on Auditing Standards No. 72 (as amended), addressed to the Underwriters; and

4. Opinion of Pellwick Raine LLP dated March 21, 2023, delivered by Harrison Blake, Partner, on behalf of the Underwriters, addressed to the Underwriters, relating to the Offering and the Transaction Documents.

CONFIDENTIAL
CALDERWOOD & HARKNESS LLP 425 Lexington Avenue New York, NY 10174
Telephone: (212) 558-4000 Facsimile: (212) 558-3588 www.calderwoodharkness.com
March 21, 2023
Keystone Mercer & Co., LLC as Representative of the Several Underwriters 280 Park Avenue, 14th Floor New York, NY 10017
Copy to:
Ridgeline Capital Markets, Inc. 100 Summer Street, Suite 2400 Boston, MA 02110
Broadleaf Partners LLC 600 Travis Street, Suite 3100 Houston, TX 77002
Ladies and Gentlemen:
Re: Initial Public Offering of American Depositary Shares of Solstice Biomedical Devices Limited
We have acted as United States counsel to Solstice Biomedical Devices Limited, a private company limited by shares incorporated in Ireland under the Companies Act 2014 (CRO No. 587412) (the "Company"), in connection with the initial public offering (the "Offering") of American Depositary Shares ("ADSs") of the Company. This opinion letter is delivered to you pursuant to Section 5(e) of the Underwriting Agreement dated March 2, 2023 (the "Underwriting Agreement") among the Company and Keystone Mercer & Co., LLC, as representative (the "Representative") of the several underwriters named therein (collectively, the "Underwriters"), as a condition to the obligations of the Underwriters at the closing of the Offering occurring on the date hereof.
The Offering consists of 6,666,667 firm ADSs (the "Firm ADSs") and up to 1,000,000 additional ADSs (the "Option ADSs" and, together with the Firm ADSs, the "Offered ADSs") issuable upon exercise of the overallotment option granted by the Company to the Underwriters pursuant to Section 2(b) of the Underwriting Agreement. Each ADS represents one (1) ordinary share, nominal value €0.01 per share, of the Company (the "Ordinary Shares"). The Ordinary Shares underlying the Firm ADSs and, if applicable, the Option ADSs are collectively referred to herein as the "Underlying Shares." The public offering price of the ADSs is $11.0769 per ADS, resulting in aggregate gross proceeds to the Company of $73,846,089.23 for the Firm ADSs and up to $85,000,006.90 assuming full exercise of the overallotment option (approximately $85,000,000). The ADSs have been assigned CUSIP number 83472R 109 and are listed on the Nasdaq Global Market under the ticker symbol "SBDX."
I. DEFINITIONS
As used in this opinion letter, the following terms have the meanings set forth below:
"ADSs" means American Depositary Shares, each representing one (1) Ordinary Share, issued pursuant to the Deposit Agreement.
"Company" means Solstice Biomedical Devices Limited, a private company limited by shares incorporated in Ireland under the Companies Act 2014 (CRO No. 587412), with its registered office at Unit 7, Lakeview Technology Campus, Parkmore East, Galway, H91 XK72, Ireland.
"Deposit Agreement" means the Deposit Agreement dated March 2, 2023, among the Company, Meridian Trust Company, N.A. ("Meridian Trust"), as depositary, and all holders and beneficial owners of ADSs issued thereunder from time to time, as such agreement may be amended, supplemented, or otherwise modified in accordance with its terms.
"Effective Date" means February 28, 2023, the date on which the Registration Statement was declared effective by the United States Securities and Exchange Commission (the "SEC").
"Exchange Act" means the Securities Exchange Act of 1934, as amended, and the rules and regulations of the SEC promulgated thereunder.
"Lock-Up Agreements" means the lock-up agreements, in the form attached as Exhibit A to the Underwriting Agreement, executed by certain directors, executive officers, and holders of one percent (1%) or more of the pre-IPO Ordinary Shares in favor of Keystone Mercer & Co., LLC, as representative of the Underwriters, pursuant to which such persons have agreed to a 180-day restriction period commencing on March 2, 2023 (the Pricing Date) and expiring on August 29, 2023, subject to certain customary exceptions set forth therein.
"Ordinary Shares" means ordinary shares of the Company, nominal value €0.01 per share.
"Pricing Date" means March 2, 2023.
"Prospectus" means the final prospectus dated March 2, 2023, forming part of the Registration Statement, as filed with the SEC pursuant to Rule 424(b)(4) under the Securities Act on March 3, 2023, including all documents incorporated by reference therein.
"Registration Rights Agreement" means the Registration Rights Agreement dated 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., as such agreement may be amended, supplemented, or otherwise modified in accordance with its terms.
"Registration Statement" means the Registration Statement on Form S-1 (File No. 333-268514) filed by the Company with the SEC under the Securities Act, including all amendments thereto (including all pre-effective and post-effective amendments), all exhibits and schedules thereto, and the Prospectus included therein, as declared effective by the SEC on the Effective Date.
"Securities Act" means the Securities Act of 1933, as amended, and the rules and regulations of the SEC promulgated thereunder.
"Transaction Documents" means, collectively, the Underwriting Agreement, the Deposit Agreement, and the Registration Rights Agreement.
"Underwriting Agreement" has the meaning assigned to it in the introductory paragraph of this opinion letter.
II. SCOPE OF EXAMINATION; DOCUMENTS REVIEWED
In connection with rendering the opinions set forth herein, we have examined originals or copies (certified or otherwise identified to our satisfaction) of the following documents, certificates, records, and instruments:
1.  The Registration Statement on Form S-1 (File No. 333-268514), including all amendments thereto (Amendment Nos. 1 through 4) and all exhibits and schedules thereto, as declared effective by the SEC on February 28, 2023;
2.  The Prospectus dated March 2, 2023, as filed with the SEC pursuant to Rule 424(b)(4) under the Securities Act;
3.  The executed Underwriting Agreement dated March 2, 2023, among the Company and the Underwriters;
4.  The executed Deposit Agreement dated March 2, 2023, among the Company, Meridian Trust Company, N.A., as depositary, and all holders and beneficial owners of ADSs from time to time;
5.  The executed Registration Rights Agreement dated 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.;
6.  Forms of Lock-Up Agreements, in the form attached as Exhibit A to the Underwriting Agreement, executed by the directors, executive officers, and holders of one percent (1%) or more of the pre-IPO Ordinary Shares of the Company, covering in the aggregate 23,480,000 Ordinary Shares, representing approximately 83.9% of the total pre-IPO Ordinary Shares outstanding;
7.  The memorandum and articles of association of the Company, as amended and restated, including the special resolution adopted by the shareholders of the Company on February 15, 2023, approving the amendment to the authorized share capital of the Company to 100,000,000 Ordinary Shares, nominal value €0.01 each;
8.  Resolutions of the board of directors of the Company, adopted at meetings duly convened and held on January 24, 2023 and March 1, 2023, authorizing, among other things, the Offering, the execution and delivery of each of the Transaction Documents, and the issuance of up to 7,666,667 Ordinary Shares underlying the ADSs (consisting of 6,666,667 Ordinary Shares underlying the Firm ADSs and 1,000,000 Ordinary Shares underlying the Option ADSs);
9.  Resolutions of the shareholders of the Company, adopted at an extraordinary general meeting duly convened and held on February 15, 2023, approving the amendment to the authorized share capital of the Company as described in item 7 above and granting authority to the board of directors to allot and issue Ordinary Shares in connection with the Offering, including the disapplication of statutory preemption rights under Part 4 of the Irish Companies Act 2014;
10.  The certificate of incorporation of the Company (dated April 17, 2017) and related filings with the Irish Companies Registration Office ("CRO"), including the annual returns filed through the date hereof, evidencing the Company's incorporation and continued registration under CRO No. 587412;
11.  An Officers' Certificate of the Company dated March 21, 2023, executed by Dr. Cormac Tierney, Chief Executive Officer, and Ronan McBride, Chief Financial Officer (the "Officers' Certificate"), certifying as to certain factual matters relevant to the opinions expressed herein;
12.  A Secretary's Certificate of the Company dated March 21, 2023, executed by Fiona Callaghan, Company Secretary, certifying as to the incumbency of the officers and directors of the Company, attaching true and complete copies of the board and shareholder resolutions described in items 8 and 9 above, and certifying the completeness and accuracy of the constitutional documents of the Company;
13.  A certificate of good standing (or status) with respect to the Company issued by the Irish CRO, dated March 16, 2023;
14.  A certificate of incorporation issued by the Secretary of State of the State of Delaware and a certificate of good standing issued by the Secretary of State of the State of Delaware, each with respect to Solstice Surgical Inc., a Delaware corporation (EIN 87-4231568), the Company's wholly owned U.S. subsidiary; and
15.  Such other documents, certificates, records, and instruments as we have deemed necessary or appropriate for purposes of rendering the opinions expressed herein.
In our examination, we have assumed the genuineness of all signatures, the legal capacity of all natural persons, the authenticity of all documents submitted to us as originals, the conformity to the originals of all documents submitted to us as copies, and the accuracy and completeness of all documents and records that we have reviewed. We have relied, without independent verification, upon certificates and other assurances of officers and other representatives of the Company and upon certificates and statements of public officials as to matters of fact.
III. ASSUMPTIONS
In rendering the opinions expressed herein, we have assumed, in addition to the assumptions set forth elsewhere in this opinion letter, the following:
(a) All signatures on all documents examined by us are genuine, and all documents submitted to us as originals are authentic and complete. All documents submitted to us as copies conform to the originals thereof, and all such originals are authentic and complete.
(b) Each natural person executing any document examined by us had, at the time of such execution, full legal capacity to do so.
(c) Each of the Transaction Documents has been duly authorized, executed, and delivered by each party thereto other than the Company, including by the Underwriters (Keystone Mercer & Co., LLC, Ridgeline Capital Markets, Inc., and Broadleaf Partners LLC), by Meridian Trust Company, N.A. (as depositary under the Deposit Agreement), and by each of Greystone Ventures Fund III, L.P., Pinnacle Health Innovation Fund, L.P., and Elkridge Growth Partners II, L.P. (as parties to the Registration Rights Agreement).
(d) All certificates, representations, and statements of officers of the Company and of public officials that we have relied upon in connection with this opinion are accurate and complete in all material respects as of the date hereof.
(e) Each of the Underwriters is duly organized, validly existing, and in good standing under the laws of its respective jurisdiction of organization: Keystone Mercer & Co., LLC is a limited liability company duly organized under the laws of the State of Delaware; Ridgeline Capital Markets, Inc. is a corporation duly incorporated under the laws of the State of Delaware; and Broadleaf Partners LLC is a limited liability company duly organized under the laws of the State of Delaware.
(f) Meridian Trust Company, N.A. is duly organized and validly existing as a national banking association under the laws of the United States and has the requisite power and authority to enter into and perform its obligations under the Deposit Agreement.
(g) All consents, approvals, authorizations, orders, registrations, qualifications, licenses, and permits required to be obtained by persons and entities other than the Company in connection with the execution, delivery, and performance of the Transaction Documents and the consummation of the transactions contemplated thereby have been duly obtained and are in full force and effect as of the date hereof.
(h) The choice of governing law provisions contained in the Transaction Documents are valid and enforceable, and the courts of the relevant jurisdictions would give effect thereto.
(i) No assumption or opinion is expressed with respect to the laws of Ireland or any other jurisdiction other than the federal laws of the United States, the laws of the State of New York, and the laws of the State of Delaware. Our opinions relating to matters governed by the laws of Ireland are based solely on our review of and reliance upon the opinion of Ashford Hale & Partners, Solicitors (Dublin), as Irish counsel to the Company, delivered at the closing on the date hereof. We express no independent opinion on such matters.
IV. QUALIFICATIONS AND LIMITATIONS
The opinions expressed herein are subject to the following qualifications and limitations:
A. Jurisdictional Limitation. The opinions expressed in this letter are limited in all respects to (a) the federal laws of the United States of America, (b) the laws of the State of New York, and (c) the laws of the State of Delaware (which is the governing law of the Underwriting Agreement and the Registration Rights Agreement). We express no opinion with respect to the laws of Ireland or any other jurisdiction, and we note that the Company is incorporated under the laws of Ireland and that certain matters relating to the Company's incorporation, corporate status, authorized share capital, validity and issuance of Ordinary Shares, and constitutional documents are governed by the Irish Companies Act 2014 and other laws of Ireland. With respect to such matters, we have relied solely upon the opinion of Ashford Hale & Partners, Solicitors, delivered at the closing on the date hereof, and the certificates and confirmations of the Irish Companies Registration Office referred to in Section II above. Our opinions regarding the valid issuance, full payment, and nonassessability of the Ordinary Shares are qualified by and subject to such reliance.
B. Bankruptcy and Insolvency Qualification. The opinions expressed herein regarding the enforceability of the Transaction Documents and the obligations of the Company thereunder are subject to and qualified by (a) applicable bankruptcy, insolvency, reorganization, receivership, moratorium, fraudulent conveyance, fraudulent transfer, preference, and other similar laws relating to or affecting the enforcement of creditors' rights generally (including, without limitation, the United States Bankruptcy Code, Title 11, United States Code), and (b) general principles of equity, including principles of commercial reasonableness, good faith, and fair dealing (regardless of whether enforcement is sought in a proceeding at law or in equity), and the discretion of the court before which any proceeding therefor may be brought. We express no opinion as to (i) the availability of any particular remedy, including specific performance, injunctive relief, or any other equitable remedy, upon any breach of any Transaction Document, or (ii) the enforceability of any provision of any Transaction Document that purports to waive broadly or limit any rights, defenses, or counterclaims.
C. Securities Act Qualification. Except as specifically set forth in Opinions 7 and 10 below and in the negative assurance statement set forth in Section VI, we express no opinion that the Registration Statement or the Prospectus complies in all respects with the requirements of the Securities Act or the rules and regulations of the SEC promulgated thereunder, including Regulation S-K, Regulation S-X, and Regulation C. The negative assurance provided in Section VI is furnished in accordance with customary practice for opinions delivered in connection with registered offerings of securities and is subject to the limitations and exclusions stated therein.
D. No Opinion on Tax Matters. We do not express any opinion with respect to any federal, state, local, or foreign tax consequences arising from or relating to the Offering, the issuance of the Ordinary Shares or the ADSs, or any other transaction contemplated by the Transaction Documents. Tax consequences related to the Company and its shareholders, including the Company's status or potential status as a "passive foreign investment company" (PFIC) within the meaning of Section 1297 of the Internal Revenue Code of 1986, as amended, Irish withholding tax, and related matters, are addressed separately in the tax memorandum prepared by Sylvia Hartwell, Partner, Tax Department, Calderwood & Harkness LLP, dated February 10, 2023, a copy of which has been furnished to the Underwriters.
E. No Opinion on FDA Regulatory Matters. We do not express any opinion with respect to the regulatory status of any product of the Company or any of its subsidiaries under the Federal Food, Drug, and Cosmetic Act, as amended, or any regulations of the United States Food and Drug Administration (the "FDA"). Without limiting the generality of the foregoing, we express no opinion regarding the status, validity, or effect of FDA 510(k) clearance K211847 for the Company's NeuroPath™ neurovascular access system or Investigational Device Exemption (IDE) G220035 for the Company's OrthoSync™ spinal fixation platform, or the Company's compliance with FDA requirements generally.
F. Cutoff Date. This opinion letter speaks only as of the date hereof. We assume no obligation, and expressly disclaim any obligation, to update or supplement this opinion letter to reflect any facts or circumstances that may hereafter come to our attention or any changes in applicable law (whether by legislative action, judicial decision, or otherwise) that may hereafter occur, regardless of whether any such facts, circumstances, or changes may affect the opinions expressed herein.
V. OPINIONS
Based upon and subject to the foregoing, and subject to the assumptions, qualifications, and limitations set forth herein, we are of the opinion that:
Opinion 1 — Due Organization and Existence of the Company. Based solely on our review of the certificate of incorporation issued by the Irish Companies Registration Office, the certificate of good standing (status) issued by the Irish CRO dated March 16, 2023, and the Officers' Certificate dated March 21, 2023, and in reliance upon the opinion of Ashford Hale & Partners, Solicitors, as Irish counsel to the Company, the Company has been duly incorporated and is validly existing as a private company limited by shares under the laws of Ireland, CRO No. 587412, and has not been struck off the register or dissolved.
Opinion 2 — Due Organization and Existence of the U.S. Subsidiary. Solstice Surgical Inc. (EIN 87-4231568) is a corporation duly incorporated, validly existing, and in good standing under the laws of the State of Delaware, based on our review of the certificate of incorporation filed with the Secretary of State of the State of Delaware and the certificate of good standing issued by the Secretary of State of the State of Delaware as of a recent date.
Opinion 3 — Corporate Power and Authority. The Company has the requisite corporate power and authority under its memorandum and articles of association, as amended and restated, and under applicable law (insofar as we opine thereon), to execute and deliver each of the Transaction Documents (namely, the Underwriting Agreement, the Deposit Agreement, and the Registration Rights Agreement), to perform its obligations thereunder, and to consummate the transactions contemplated thereby, including, without limitation, the issuance and sale of the Ordinary Shares underlying the Firm ADSs and the Option ADSs.
Opinion 4 — Due Authorization. The execution, delivery, and performance by the Company of each of the Transaction Documents, and the issuance and sale by the Company of up to 7,666,667 Ordinary Shares (consisting of 6,666,667 Ordinary Shares underlying the Firm ADSs and 1,000,000 Ordinary Shares underlying the Option ADSs), have been duly authorized by all necessary corporate action on the part of the Company, including the adoption of resolutions by the board of directors of the Company at duly convened and held meetings on January 24, 2023 and March 1, 2023, and the adoption of resolutions by the shareholders of the Company at a duly convened and held extraordinary general meeting on February 15, 2023 (approving, among other things, the amendment to the authorized share capital and the disapplication of statutory preemption rights). Such resolutions have not been rescinded, amended, or modified and remain in full force and effect as of the date hereof.
Opinion 5 — Valid Issuance of Ordinary Shares. The Ordinary Shares underlying the ADSs, when issued and delivered by the Company against payment therefor in accordance with the terms and conditions of the Underwriting Agreement and deposited with Meridian Trust Company, N.A., as depositary, in accordance with the terms and conditions of the Deposit Agreement, will be validly issued, fully paid, and nonassessable (to the extent the concept of "nonassessability" is applicable under Irish law, and with reliance on the opinion of Ashford Hale & Partners, Solicitors, as Irish counsel to the Company, with respect to such matters under Irish law). Upon issuance of all Underlying Shares (assuming full exercise of the overallotment option), the total number of issued and outstanding Ordinary Shares of the Company will be 35,666,667, which does not exceed the authorized share capital of 100,000,000 Ordinary Shares, nominal value €0.01 each. Accordingly, sufficient authorized but unissued Ordinary Shares exist for the issuance of all Underlying Shares.
Opinion 6 — Enforceability of Transaction Documents. Each of the Transaction Documents has been duly executed and delivered by the Company and constitutes the legal, valid, and binding obligation of the Company, enforceable against the Company in accordance with its terms, except as the enforceability thereof may be limited by (a) applicable bankruptcy, insolvency, reorganization, moratorium, fraudulent conveyance, fraudulent transfer, and similar laws affecting creditors' rights generally, and (b) general principles of equity (regardless of whether enforcement is sought in a proceeding at law or in equity), as more fully described in Section IV(B) above. We note that the Underwriting Agreement is governed by the laws of the State of Delaware, and the Registration Rights Agreement is governed by the laws of the State of Delaware. The Deposit Agreement is governed by the laws of the State of New York.
Opinion 7 — Registration Statement and Prospectus. The Registration Statement on Form S-1 (File No. 333-268514) has been filed with the SEC and declared effective by the SEC as of February 28, 2023. As of the date hereof, no stop order suspending the effectiveness of the Registration Statement has been issued by the SEC, and, to our knowledge, no proceedings for that purpose have been instituted or are threatened by the SEC. The ADSs (and the Ordinary Shares represented thereby) have been registered under the Securities Act pursuant to the Registration Statement.
Opinion 8 — No Conflicts. The execution, delivery, and performance by the Company of each of the Transaction Documents, the issuance and sale of the Ordinary Shares, and the issuance of the ADSs by Meridian Trust (to the extent the Company's actions are concerned), do not and will not:
(a) violate, conflict with, or result in a breach or default under any provision of the memorandum and articles of association of the Company, as currently in effect;
(b) to our knowledge, violate any federal statute, rule, or regulation of the United States or any statute, rule, or regulation of the State of New York applicable to the Company; or
(c) result in a violation of any order, judgment, injunction, award, or decree of any court, arbitrator, or governmental or regulatory authority known to us to be binding upon or applicable to the Company or any of its properties or assets.
We note that the foregoing opinion does not address the laws of Ireland or any other jurisdiction other than the federal laws of the United States and the laws of the State of New York, and our opinion with respect to the Company's memorandum and articles of association is based on our review of the English-language text thereof as certified by the Secretary's Certificate.
Opinion 9 — No Consents Required (Other Than Those Obtained). No consent, approval, authorization, order, registration, or qualification of or with any federal or New York State court, governmental agency, or regulatory body is required for the execution and delivery by the Company of the Transaction Documents, or for the issuance and sale of the Ordinary Shares and the ADSs as contemplated by the Transaction Documents, except for:
(a) the declaration of effectiveness of the Registration Statement by the SEC under the Securities Act, which was obtained on February 28, 2023;
(b) the filing of the Prospectus with the SEC pursuant to Rule 424(b) under the Securities Act, which was made on March 3, 2023;
(c) the approval of the listing of the ADSs on the Nasdaq Global Market under the ticker symbol "SBDX," which has been obtained;
(d) the indication by the Financial Industry Regulatory Authority, Inc. ("FINRA") that it has no objection to the proposed underwriting terms and arrangements, which has been received; and
(e) such consents, approvals, authorizations, registrations, or qualifications as may be required under state securities or "Blue Sky" laws in connection with the purchase and distribution of the ADSs by the Underwriters, as to which we express no opinion.
Opinion 10 — Exchange Act Registration. The ADSs have been duly registered by the Company under Section 12(b) of the Exchange Act and have been approved for listing on the Nasdaq Global Market under the ticker symbol "SBDX." The Registration Statement on Form 8-A (File No. 001-41389), registering the ADSs under the Exchange Act, has been filed with the SEC and has become effective.
Opinion 11 — Investment Company Act. Based on our review of the Company's business, assets, and operations as described in the Registration Statement and the Prospectus, and in reliance upon the representations contained in the Officers' Certificate, the Company is not, and after giving effect to the Offering and the application of the net proceeds thereof as described in the Prospectus under the heading "Use of Proceeds," will not be, required to register as an "investment company" within the meaning of the Investment Company Act of 1940, as amended (the "Investment Company Act"), and the rules and regulations of the SEC promulgated thereunder.
VI. NEGATIVE ASSURANCE (10b-5 STATEMENT)
In addition to, and not in lieu of, the opinions set forth in Section V above, we advise you as follows:
We have participated in the preparation of the Registration Statement and the Prospectus and have participated in conferences and discussions with officers and other representatives of the Company (including Dr. Cormac Tierney, Chief Executive Officer, Ronan McBride, Chief Financial Officer, and Dr. Siobhán Keane, Vice President of Regulatory Affairs), representatives of Calderwood & Associates LLP (the Company's independent registered public accounting firm, including Patricia Yuen, engagement partner), representatives of the Underwriters, and representatives of Pellwick Raine LLP (counsel to the Underwriters, including Harrison Blake, Partner), at which the contents of the Registration Statement and the Prospectus and related matters were discussed. We have also reviewed the documents listed in Section II above. We have not, however, independently verified the accuracy, completeness, or fairness of the statements contained in the Registration Statement or the Prospectus (or any amendment or supplement thereto).
Based upon and subject to the foregoing (but without independent verification of any of the facts, data, representations, or information contained therein), and subject to the assumptions, qualifications, and limitations set forth in this opinion letter:
(i) Nothing has come to our attention that causes us to believe that the Registration Statement (File No. 333-268514), at the time it became effective on February 28, 2023, contained an untrue statement of a material fact or omitted to state a material fact required to be stated therein or necessary to make the statements therein not misleading.
(ii) Nothing has come to our attention that causes us to believe that the Prospectus, as of its date (March 2, 2023), or as of the date hereof (March 21, 2023), contained or contains an untrue statement of a material fact or omitted or omits 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.
Notwithstanding the foregoing, the negative assurance statements set forth in this Section VI do not extend to, and we express no belief with respect to:
(a) the financial statements of the Company and the related notes and schedules thereto included in or incorporated by reference into the Registration Statement or the Prospectus, which have been audited by Calderwood & Associates LLP, as set forth in their report included therein;
(b) any financial data or other financial information derived from the audited or unaudited financial statements of the Company or from the accounting records of the Company; or
(c) any XBRL interactive data filed as an exhibit to or incorporated by reference into the Registration Statement.
The statements set forth in this Section VI are provided in accordance with customary practice in connection with opinions delivered by issuer's counsel in registered public offerings of securities and should not be construed as an independent investigation or verification of the facts, data, or information contained in the Registration Statement or the Prospectus. Our participation in the preparation of the Registration Statement and the Prospectus was limited to matters of a legal nature, and we have not participated in the preparation of, and are not in a position to express any view with respect to, the financial statements, financial data, or statistical data contained therein.
VII. RELIANCE AND BENEFIT
This opinion letter is furnished solely for the benefit of the addressees hereof — namely, Keystone Mercer & Co., LLC, as Representative of the Several Underwriters, Ridgeline Capital Markets, Inc., and Broadleaf Partners LLC (collectively, the "Underwriters") — in connection with the Transaction Documents and the transactions contemplated thereby, and may not be relied upon by any other person or entity, or for any other purpose, without our prior written consent in each instance.
This opinion letter may not be quoted in whole or in part, summarized, paraphrased, or otherwise referred to in any public document, filing, or statement, or otherwise furnished to any other person or entity, without our prior written consent, except (a) as may be required by applicable law or regulation, (b) as may be required in connection with any regulatory examination or proceeding, (c) as an exhibit to the Registration Statement, or (d) in connection with the enforcement of rights under the Transaction Documents, in each case to the extent required.
Notwithstanding the foregoing, Pellwick Raine LLP, as counsel to the Underwriters, may rely on this opinion letter in connection with any opinion or negative assurance letter delivered by Pellwick Raine LLP to the Underwriters in connection with the Offering and the Transaction Documents, to the same extent as if this opinion letter were addressed directly to Pellwick Raine LLP.
VIII. GENERAL PROVISIONS
This opinion letter is limited to the specific legal matters expressly addressed herein, and no opinion is to be implied or inferred beyond the matters expressly stated. We have not been asked to, and do not, opine on any matter not expressly set forth in this opinion letter.
We have not been asked to, and do not, express any opinion on any matter governed by the laws of Ireland. With respect to matters of Irish law, including without limitation the due incorporation and valid existence of the Company under the Irish Companies Act 2014, the Company's authorized and issued share capital, the validity and enforceability of the Company's memorandum and articles of association, and the valid issuance of Ordinary Shares under Irish law, we have relied solely upon the opinion of Ashford Hale & Partners, Solicitors (Dublin), delivered at the closing on the date hereof.
We express no opinion herein as to any matter of fact, and the opinions expressed herein are based solely on facts as they exist on the date hereof as reflected in the documents and certificates we have reviewed.
We assume no obligation to advise you, or any other person or entity, of any changes in applicable law or any changes in fact or circumstances that may occur or come to our attention after the date hereof, whether or not such changes may affect the opinions expressed herein. This opinion letter is not to be construed as a guarantee, warranty, or prediction of the outcome of any legal proceeding or dispute.
This opinion letter is governed by, and shall be construed and interpreted in accordance with, the laws of the State of New York, including the applicable provisions of the New York Rules of Professional Conduct and ABA/ABCNY legal opinion guidelines. The opinions expressed herein are rendered as of the date hereof and are based on the law in effect on the date hereof.
We trust that the foregoing is sufficient for your purposes. Should you have any questions regarding this opinion letter, please do not hesitate to contact the undersigned at (212) 558-4217 or at tlangston@calderwoodharkness.com.
Very truly yours,
CALDERWOOD & HARKNESS LLP
By: ________
Theodore Langston Partner, Capital Markets
CLOSING DELIVERABLES
This opinion letter is delivered together with, and should be read in conjunction with, the following closing deliverables referenced in the Closing Checklist attached as Schedule 1 to the Underwriting Agreement:
1.  Officers' Certificate of the Company dated March 21, 2023, executed by Dr. Cormac Tierney, Chief Executive Officer, and Ronan McBride, Chief Financial Officer, certifying as to the accuracy of representations and warranties and the satisfaction of conditions to closing;
2.  Secretary's Certificate of the Company dated March 21, 2023, executed by Fiona Callaghan, Company Secretary, attaching certified copies of the board of directors resolutions (January 24, 2023 and March 1, 2023), shareholder resolutions (February 15, 2023), incumbency certificates for the officers and directors of the Company, and the memorandum and articles of association of the Company (as amended and restated);
3.  Comfort Letter of Calderwood & Associates LLP dated March 21, 2023, delivered by Patricia Yuen, engagement partner, in accordance with Statement on Auditing Standards No. 72 (as amended), addressed to the Underwriters; and
4.  Opinion of Pellwick Raine LLP dated March 21, 2023, delivered by Harrison Blake, Partner, on behalf of the Underwriters, addressed to the Underwriters, relating to the Offering and the Transaction Documents.

CONFIDENTIAL

I. DEFINITIONS

III. ASSUMPTIONS

IV. QUALIFICATIONS AND LIMITATIONS

V. OPINIONS

VII. RELIANCE AND BENEFIT

VIII. GENERAL PROVISIONS

CALDERWOOD & HARKNESS LLP

CLOSING DELIVERABLES

Record

Parties

Dates

Amounts