Contract analysis

I. Executive Summary This memorandum presents the results of a comprehensive legal review conducted by Calderwood & Harkness LLP ("C&H") of the proposed United States promotional materials, labeling, advertising, sales training presentations, and website content that Solstice Biomedical Inc. ("Solstice" or the "Company") intends to deploy in connection with the planned October 1, 2024 commercial launch of the Pulsar™

II. Background A. Solstice Biomedical Devices Ltd. — Company Overview Solstice Biomedical Devices Ltd. ("Solstice Biomedical" or "Solstice Parent") is an Irish-headquartered medical device company focused on the development and commercialization of implantable cardiac monitoring technologies. The company maintains its principal offices at Unit 14, Clarion Business Park, Sandyford, Dublin D18 X4F2, Ireland. Solstice B

III. Applicable Regulatory Framework A. Federal Food, Drug, and Cosmetic Act — Promotional and Labeling Provisions The FD&C Act, 21 U.S.C. §§ 301 et seq., establishes the principal federal framework governing the promotion and labeling of medical devices. Several provisions are directly relevant to this review. FD&C Act § 201(m) (21 U.S.C. § 321(m)) — Definition of "Labeling." The statute defines "labeling" as "all l

§ 801.4 — Adequate Directions for Use. Labeling must include adequate directions for use, which the regulation defines as directions under which a layperson can use the device safely and for the purposes for which it is intended. For prescription devices such as the Pulsar™ CRM System, this requirement is satisfied through compliance with § 801.109 (discussed below).

§ 801.5 — Adequate Warnings. Where a device is intended for use by persons other than healthcare professionals, labeling must bear adequate warnings against uses or methods of use that are dangerous to health, as well as appropriate cautionary statements. Even for prescription devices, promotional materials directed at healthcare professionals must include adequate risk and warning information to enable informed pres

§ 801.6 — Prominence of Required Label Statements. Required label statements must be prominently placed on the label with such conspicuousness and in such terms as to render them likely to be read and understood by the ordinary individual under customary conditions of purchase and use. This requirement supports the fair balance principle: risk information that is technically present but practically invisible due to s

§ 801.109 — Exemptions for Prescription Devices. A prescription device is exempt from the requirement of § 801.4 for adequate directions for use by laypeople, provided that: (1) the device is for use by or on the order of a licensed practitioner; (2) the labeling bears the statement "Caution: Federal law restricts this device to sale by or on the order of a [physician/licensed practitioner]" (or equivalent); and (3)

§ 807.81 and § 807.87 — Submission Requirements. Under § 807.81(a)(3) and § 807.87(e), manufacturers of devices cleared through the 510(k) process must submit to FDA, at the time of initial commercial distribution or at the time an advertisement or labeling material is first disseminated after clearance—whichever comes first—a copy or specimen of the device's labeling and any advertising material relating to the devi

1. Risk information must be presented with comparable prominence and readability as benefit claims. Materials that feature benefit claims in large, bold, colorful text while relegating risk information to small, inconspicuous text at the bottom of a page or on a separate page violate the fair balance requirement.

2. Specific risks, contraindications, and warnings from the cleared labeling must be included. Promotional materials must disclose the risks identified in the Device's cleared labeling, including but not limited to risks associated with the implantation procedure, device-related adverse events, electromagnetic interference, and MRI compatibility limitations.

3. Selective omission of risk information is impermissible. FDA has specifically targeted promotional materials that "broaden" a device's indicated use through the selective omission of risk information or limitations identified in the cleared labeling. A promotional piece that highlights the Device's benefits without disclosing its limitations creates a misleading impression of the Device's risk-benefit profile.

4. Space-constrained formats must still provide access to risk information. For digital advertisements and other space-limited formats, FDA's guidance on internet and social media promotion provides that the material must include, at minimum, a brief statement of important risks and a clear, conspicuous link to the full risk information, accessible in no more than one click. FDA has made fair balance a significant en

IV. Review of Draft Promotional Materials A. Methodology. C&H conducted a line-by-line review of each of the fourteen (14) draft promotional materials identified in Section II.D above. Each item was reviewed against the following reference documents: (1) the 510(k) Summary for K232847; (2) the cleared Indications for Use statement; (3) the Device labeling, including the Instructions for Use ("IFU") for both the impla

V. Review of Sales Training Decks A. Training Deck 1 — "Pulsar™ CRM System Product Training" (87 Slides) This presentation was prepared by Patrick Dunne's marketing team and is intended to serve as the primary product training resource for the US commercial organization. The deck covers device features, clinical benefits, implantation procedure, remote telemetry platform operation, cleared indications and contraindic

VI. Review of Website Content A. Scope of Website Review C&H reviewed all twenty-two (22) pages of the solsticebiomed.com US portal as of the date of this memorandum. The pages reviewed include: • Home page • Pulsar™ CRM System main product page • Pulsar™ Remote Telemetry Transmitter product page • Clinical Evidence page • Physician Resources section (4 pages) • Patient Information section (3 pages) • Reimbursement I