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Contract analysis / legal-due-diligence-report.docx
legal-due-diligence-report.docx
1037-00006 · 37 clauses
High · 7 Medium · 5 Standard · 3
I. EXECUTIVE SUMMARY High
⚑ Non-compete / exclusivity restraint
I. EXECUTIVE SUMMARY Calderwood & Harkness LLP ("Calderwood & Harkness" or "we") has prepared this Legal Due Diligence Report (this "Report") in connection with the proposed acquisition (the "Transaction") by Solstice Biomedical, Inc., a Delaware corporation and wholly owned subsidiary of Solstice Biomedical Devices Ltd., an Irish public limited company (together, the "Buyer" or "Solstice"), of one hundred percent (1
II. CORPORATE ORGANIZATION AND GOOD STANDING
II. CORPORATE ORGANIZATION AND GOOD STANDING
II.A. Incorporation and Organizational Documents High
⚑ Indemnity / guarantee obligation
II.A. Incorporation and Organizational Documents Meridian Surgical Technologies, Inc. was incorporated in the State of Delaware on September 14, 2018, under Delaware File Number 5819734. The Company's Employer Identification Number is 84-3192057. We have reviewed the Company's Certificate of Incorporation, as originally filed with the Delaware Secretary of State, together with all amendments thereto through the date
II.B. Good Standing
II.B. Good Standing We obtained a Certificate of Good Standing from the Delaware Secretary of State confirming that Meridian is in good standing and that all franchise taxes have been paid through the current period. The certificate is current as of July 29, 2024. We also obtained a Certificate of Good Standing from the Pennsylvania Department of State confirming that Meridian is authorized to transact business in th
II.C. Board of Directors
II.C. Board of Directors The Company's Board of Directors currently consists of five directors and one non-voting board observer. The current composition of the Board is as follows:
1. Dr. Marcus Ellsworth — Director and Chairman of the Board. Dr. Ellsworth is the founde
1. Dr. Marcus Ellsworth — Director and Chairman of the Board. Dr. Ellsworth is the founder of the Company and currently serves as its Chief Executive Officer. He has served on the Board since the Company's incorporation in 2018.
2. Catherine Pryor — Director. Ms. Pryor serves as the Company's President and Chief Oper
2. Catherine Pryor — Director. Ms. Pryor serves as the Company's President and Chief Operating Officer. She has served on the Board since 2019.
3. Gregory Ashford — Director. Mr. Ashford serves as a designee of Pennfield Growth Partn
3. Gregory Ashford — Director. Mr. Ashford serves as a designee of Pennfield Growth Partners, LP ("Pennfield") pursuant to the Stockholders' Agreement (discussed in Section III.D below). He is a Partner at Pennfield and has served on the Board since 2020.
4. Diana Whitfield — Director. Ms. Whitfield serves as the second designee of Pennfield p
4. Diana Whitfield — Director. Ms. Whitfield serves as the second designee of Pennfield pursuant to the Stockholders' Agreement. She is a Principal at Pennfield and has served on the Board since 2020.
5. Dr. Eleanor Vickers — Independent Director. Dr. Vickers is the former Chief Medical Of
5. Dr. Eleanor Vickers — Independent Director. Dr. Vickers is the former Chief Medical Officer of Westbrook Health Systems and was appointed to the Board in 2021. She serves as the sole independent director and chairs the Board's Compensation Committee.
6. Samuel Nakamura — Board Observer (non-voting). Mr. Nakamura serves as the designee of
6. Samuel Nakamura — Board Observer (non-voting). Mr. Nakamura serves as the designee of Arch Hill Ventures Fund II, LLC ("Arch Hill") pursuant to the Stockholders' Agreement. He is a Managing Director at Arch Hill Ventures. We have reviewed the minutes of all meetings of the Board of Directors and all written consents in lieu of meetings from January 2021 through August 2024. All material corporate actions reflected
II.D. Subsidiaries and Affiliates
II.D. Subsidiaries and Affiliates Based on the representations of Meridian management and our review of the Data Room materials, Meridian has no subsidiaries, joint ventures, partnerships, or minority equity interests in any other entity. The Company conducts all of its operations directly and does not utilize any special purpose vehicles or affiliated entities.
III.A. Outstanding Equity
III.A. Outstanding Equity The Company's Certificate of Incorporation, as amended, authorizes the issuance of 10,000,000 shares of common stock, par value $0.001 per share. No class of preferred stock is authorized. As of the date of this Report, 7,450,000 shares of common stock are issued and outstanding. The shares are fully paid and non-assessable. We have reviewed the Company's stock ledger, maintained by its tran
III.B. Stockholder Breakdown
III.B. Stockholder Breakdown The 7,450,000 outstanding shares of common stock are held by the following stockholders: We have confirmed through review of the stock ledger and related transfer documents that each of the foregoing holders acquired their shares in compliance with applicable federal and state securities laws, including exemptions under Regulation D of the Securities Act of 1933, as amended, and applicabl
III.C. Options and Equity Incentive Plan Standard
⚑ Commercial term
III.C. Options and Equity Incentive Plan We have reviewed the Meridian Surgical Technologies, Inc. 2019 Equity Incentive Plan (the "Plan"), together with all individual option grant agreements issued thereunder. The material terms of the outstanding options are summarized below: • Shares reserved for issuance under outstanding options: 550,000 shares of common stock. • Vesting status: All 550,000 options are fully ve
III.D. Stockholders' Agreement and Related Agreements
III.D. Stockholders' Agreement and Related Agreements We have reviewed the Stockholders' Agreement dated March 18, 2020, among Dr. Marcus Ellsworth, Pennfield Growth Partners, LP, Arch Hill Ventures Fund II, LLC, and the Company (the "Stockholders' Agreement"), together with a First Amendment thereto dated September 12, 2021 (the "First Amendment"). The material provisions of the Stockholders' Agreement are as follow
III.E. Anti-Dilution and Preemptive Rights
III.E. Anti-Dilution and Preemptive Rights No anti-dilution protections apply to the Company's common stock. The Company has not issued preferred stock or any other equity securities with anti-dilution adjustment mechanisms.
Section 7.1 of the Stockholders' Agreement grants Pennfield and Arch Hill preemptive right
Section 7.1 of the Stockholders' Agreement grants Pennfield and Arch Hill preemptive rights with respect to any new issuances of equity securities by the Company. In connection with the proposed Transaction, each of Pennfield and Arch Hill executed waiver letters, each dated July 22, 2024, expressly waiving their respective preemptive rights with respect to the Transaction. We have reviewed both waiver letters and co
III.F. Observation
III.F. Observation The Company's capitalization is clean and straightforward. There are no outstanding warrants, convertible instruments, convertible notes, SAFEs, or other equity-linked securities beyond the fully vested stock options described above. The stock ledger is well-maintained, and all equity issuances appear to have been properly authorized and documented. No fractional shares or unusual equity arrangemen
IV.A. Summary of Approach High
⚑ Non-compete / exclusivity restraint
IV.A. Summary of Approach We have reviewed all material contracts identified in the Data Room, including all contracts specifically requested in Calderwood & Harkness's Preliminary Diligence Request List dated May 13, 2024, and Supplemental Diligence Request Lists dated June 7, 2024, and July 12, 2024. Our review focused on: (i) change-of-control provisions and consent requirements; (ii) assignability and successors
IV.B. Exclusive Supply Agreement — Titanium Precision Components, Inc. High
⚑ Non-compete / exclusivity restraint
IV.B. Exclusive Supply Agreement — Titanium Precision Components, Inc. We have reviewed the Exclusive Supply Agreement dated March 15, 2022 (the "TPC Agreement"), by and between Meridian (as buyer) and Titanium Precision Components, Inc. ("TPC"), a Pennsylvania corporation with its principal offices at 215 Industrial Park Drive, Lancaster, Pennsylvania 17601 (as supplier). TPC is the exclusive supplier of titanium in
IV.C. Distribution Agreement — OrthoLink Distribution, LLC High
⚑ Non-compete / exclusivity restraint
IV.C. Distribution Agreement — OrthoLink Distribution, LLC We have reviewed the Distribution Agreement dated January 1, 2023 (the "OrthoLink Agreement"), by and between Meridian (as supplier) and OrthoLink Distribution, LLC ("OrthoLink"), a Maryland limited liability company with its principal offices at 9400 Snowden River Parkway, Suite 300, Columbia, Maryland 21045 (as exclusive distributor). Under the OrthoLink Ag
IV.D. License Agreement — Polytechnic Innovations, Ltd. High
⚑ Non-compete / exclusivity restraint
IV.D. License Agreement — Polytechnic Innovations, Ltd. We have reviewed the License Agreement dated June 8, 2020 (the "Polytechnic License"), by and between Meridian (as licensee) and Polytechnic Innovations, Ltd. ("Polytechnic"), a United Kingdom private limited company with its principal offices at Innovation Centre, 12 Banbury Road, Oxford, OX2 6NN, United Kingdom (as licensor). The Polytechnic License grants Mer
IV.E. Ironclad Revolving Credit Facility Standard
⚑ Commercial term
IV.E. Ironclad Revolving Credit Facility We have reviewed the Loan and Security Agreement dated November 12, 2021 (the "Credit Facility"), by and between Meridian (as borrower) and Ironclad Commercial Lending, LLC ("Ironclad"), a Texas limited liability company with its principal offices at 600 Travis Street, Suite 2200, Houston, Texas 77002 (as lender). The Credit Facility provides Meridian with a $12,000,000 revolv
IV.F. Other Contracts Reviewed Medium
⚑ Assignment / subcontracting
IV.F. Other Contracts Reviewed In addition to the contracts described above, we reviewed the following categories of contracts: Customer Contracts. We reviewed Meridian's top twenty (20) customer agreements by revenue, which collectively represent approximately 78% of the Company's total revenue for FY2023. These agreements consist of standard purchase orders, master supply agreements, and group purchasing organizati
V.A. Patents Medium
⚑ Assignment / subcontracting
V.A. Patents Meridian maintains a robust patent portfolio covering the core technologies underlying its PrecisionBlade, powered shaver, and ArthroNav product lines. Our review of the patent portfolio yielded the following: Issued U.S. Utility Patents. Meridian holds fourteen (14) issued U.S. utility patents covering various aspects of minimally invasive surgical instrument design, powered shaver blade configurations
V.B. Trademarks
V.B. Trademarks Meridian holds three active trademark registrations with the USPTO, each of which is material to the Company's business: 1. "Meridian Surgical" — Registered with the USPTO; Registration No. 5,891,442; registered in International Class 10 (surgical instruments and apparatus). The mark is in active use in commerce and is current. No opposition or cancellation proceedings are pending. 2. "ArthroNav" — Re
V.C. Trade Secrets Medium
⚑ Confidentiality undertaking
V.C. Trade Secrets In addition to its patent portfolio, Meridian possesses significant trade secret assets, most notably its proprietary algorithms for real-time cartilage thickness mapping. These algorithms constitute the core technology underlying Earnout Milestone 2 — the FDA 510(k) clearance of the ArthroNav Software Module for Real-Time Cartilage Mapping (Generation 2.0). The real-time cartilage mapping technolo
V.D. Freedom-to-Operate Considerations Medium
⚑ Liability cap to check against exposure
V.D. Freedom-to-Operate Considerations The principal freedom-to-operate concern relates to the pending Hartwell Orthopedic Solutions patent infringement claim, which is discussed in detail in Section VI.A below. The Hartwell claim alleges that certain of Meridian's powered shaver blade products infringe Hartwell's U.S. Patent No. 10,891,224. The claim relates specifically to the PrecisionBlade powered shaver product
VI.A. Pending Litigation — Hartwell Orthopedic Solutions, Inc. v. Meridian Surgical Techno High
⚑ Indemnity / guarantee obligation
VI.A. Pending Litigation — Hartwell Orthopedic Solutions, Inc. v. Meridian Surgical Technologies, Inc. Case Information. • Case Name: Hartwell Orthopedic Solutions, Inc. v. Meridian Surgical Technologies, Inc. • Court: United States District Court for the Eastern District of Pennsylvania • Civil Action No.: 2:23-cv-04817 • Presiding Judge: The Honorable Margaret A. Donnelly • Filed: October 18, 2023 • Plaintiff: Hart
VI.B. Other Litigation Medium
⚑ Forum / governing law
VI.B. Other Litigation We have conducted searches of federal and state court records in the Eastern District of Pennsylvania, the Commonwealth of Pennsylvania, and the State of New Jersey, as well as the Delaware Court of Chancery and the U.S. District Court for the District of Delaware. Other than the Hartwell matter described above, no pending or threatened litigation, arbitration, or governmental proceedings invol
VI.C. Governmental Investigations
VI.C. Governmental Investigations We have confirmed through our review of the Data Room, management interviews, and public records searches that: • No pending or threatened governmental investigations by the U.S. Department of Justice ("DOJ"), the Federal Trade Commission ("FTC"), the Securities and Exchange Commission ("SEC"), or any state attorney general involve the Company. • No pending or prior actions under the
VII. REGULATORY / FDA
VII. REGULATORY / FDA This Section VII was prepared by Victoria Shen, Counsel, Regulatory & Life Sciences, Calderwood & Harkness LLP.
VII.A. Existing Product Clearances
VII.A. Existing Product Clearances Meridian's currently commercially marketed products consist of the PrecisionBlade single-use arthroscopic blade product line and the powered shaver systems. Each of these product families has received FDA 510(k) clearance for commercial distribution in the United States. We have reviewed the 510(k) clearance letters and summaries for each cleared product and confirmed the following:
VII.B. FDA Inspection History
VII.B. FDA Inspection History The FDA last inspected Meridian's Exton, Pennsylvania manufacturing facility in September 2023. The inspection was a routine surveillance inspection conducted under the Quality System Regulation (21 C.F.R. Part 820). The inspection resulted in no Form 483 observations — a result commonly referred to as a "clean" inspection. This is a positive indicator of the Company's quality system mat
VII.C. ArthroNav Platform — Regulatory Pathway Standard
⚑ Commercial term
VII.C. ArthroNav Platform — Regulatory Pathway The ArthroNav Robotic-Assisted Arthroscopy System (Generation 1.0) is Meridian's next-generation product platform and the product around which the Earnout Consideration milestones are structured. The ArthroNav Platform is currently in the pre-submission stage of the regulatory process and has not yet been submitted for FDA clearance. Pre-Submission Activity. The Company
VII.D. ISO Certification
VII.D. ISO Certification Meridian's Exton, Pennsylvania manufacturing facility holds ISO 13485:2016 certification, the international standard for quality management systems in the medical device industry. The certification details are as follows: • Certifying Body: Pinnacle Conformity Assessment Services, LLC • Certificate No.: PCA-2022