1037-00003 · Solstice Biomedical Devices Ltd · Template Agreements

template-speaker-program-agreement.docx DOCUMENT Litigation

12 / 12 ← ✕

Contract analysis Extract to table

SPEAKER PROGRAM AGREEMENT

Solstice Biomedical Inc.

Prepared by

Calderwood & Harkness LLP 1250 Avenue of the Americas, 38th Floor New York, NY 10020

Matter Reference: 1037-00003

Template Version: 1.0 — August 2024

CONFIDENTIAL — ATTORNEY-CLIENT PRIVILEGED WORK PRODUCT

This is a template form agreement. All bracketed fields must be completed for each individual speaker engagement. This template does not constitute a binding agreement until all bracketed fields have been completed, the agreement has been reviewed and approved by the applicable Solstice Biomedical Inc. authorized signatories, and the agreement has been fully executed by both parties.

INTRODUCTORY INSTRUCTIONS / USAGE NOTES

Internal Use Only — Not Part of Agreement

The following instructions are provided for the use of Solstice Biomedical Inc. ("Solstice" or the "Company") personnel and are not intended to be, and shall not be construed as, part of the Speaker Program Agreement itself. These instructions should be removed from the final executed version of each agreement.

Prepared By: This template Speaker Program Agreement has been prepared by Calderwood & Harkness LLP, outside counsel to Solstice Biomedical Inc., for use by the Company's US Commercial Operations team, Medical Affairs department, and the Medical-Legal-Regulatory (MLR) Committee in connection with the engagement of healthcare professional speakers for Company-sponsored educational programs relating to the Pulsar™ CRM System.

Pre-Approval Requirement: All speaker engagements must be pre-approved through the needs-assessment process described in Article 3 of this Agreement before this template is completed and executed. No speaker engagement may proceed without a fully completed and approved Needs-Assessment Form (Exhibit D). The needs-assessment process is a critical compliance safeguard and must not be bypassed under any circumstances.

Authorized Signatories: Completed agreements must be countersigned by one of the following authorized Company representatives:

• Marcus Reilly, Vice President, US Commercial Operations; or

• Siobhán Mulcahy, Head of Global Compliance and interim US Compliance Officer; or

• A designee formally authorized in writing by either Mr. Reilly or Ms. Mulcahy.

No other Company employee is authorized to execute this Agreement on behalf of Solstice Biomedical Inc. without prior written delegation of authority.

Record Retention and Sunshine Act Reporting: All executed agreements, together with all related Exhibits (including Needs-Assessment Forms, Training Completion Certificates, Program Completion Forms, and Expense Reimbursement Forms), must be retained in the compliance file maintained by the Office of the General Counsel for a minimum period of seven (7) years following the expiration or termination of the Agreement. All payments and transfers of value made under executed agreements must be reported through the Company's Sunshine Act tracking system (currently managed through the PharmaClear® platform) in accordance with 42 U.S.C. § 1320a-7h and implementing regulations.

Questions: Questions regarding this template, its use, or the legal and compliance requirements applicable to speaker engagements should be directed to:

• Office of the General Counsel: Declan Harrington, General Counsel, Solstice Biomedical Inc.

• Outside Counsel: Joel Strauss or Amy Whitfield, Calderwood & Harkness LLP

Do not modify any substantive provisions of this template without prior consultation with the Office of the General Counsel or outside counsel.

END OF INTRODUCTORY INSTRUCTIONS — REMOVE THIS PAGE BEFORE EXECUTION

SPEAKER PROGRAM AGREEMENT

This Speaker Program Agreement (this "Agreement") is entered into as of [Insert Effective Date] (the "Effective Date"), by and between:

SOLSTICE BIOMEDICAL INC., a Delaware corporation, with its principal offices located at 200 Harborview Drive, Suite 1100, Boston, Massachusetts 02210 (EIN: 93-4718206) (the "Company" or "Solstice"),

and

[Insert Full Legal Name of Speaker], M.D./D.O., an individual with a principal practice address at [Insert Address] (the "Speaker").

The Company and Speaker are each referred to herein individually as a "Party" and collectively as the "Parties."

RECITALS. WHEREAS, the Company is the United States subsidiary of Solstice Biomedical Devices Ltd., an Irish private limited company, and is engaged in the development, manufacture, and commercialization of innovative medical devices for cardiovascular care, including the Pulsar™ CRM System, a subcutaneous implantable cardiac monitor with an integrated cloud-based remote telemetry platform that has received clearance from the United States Food and Drug Administration ("FDA") pursuant to Section 510(k) of the Federal Food, Drug, and Cosmetic Act (510(k) No. K232847) and is classified as a Class II medical device under Product Code MHX;

WHEREAS, the Pulsar™ CRM System is indicated for continuous cardiac rhythm monitoring in adult patients with suspected or documented cardiac arrhythmias, as set forth in the FDA-cleared labeling;

WHEREAS, the Company desires to engage qualified healthcare professionals to serve as compensated speakers at Company-sponsored educational programs designed to present accurate, balanced, and on-label information regarding the Pulsar™ CRM System, its clinical applications, and related topics to audiences of healthcare professionals;

WHEREAS, Speaker is a physician duly licensed to practice medicine and possessing expertise in the field of [Insert Specialty — e.g., electrophysiology, cardiology, internal medicine with cardiac subspecialty focus], and Speaker has been identified by the Company as a qualified speaker based on a documented legitimate business need consistent with the Company's Speaker Program Policy;

WHEREAS, the Company has conducted a needs assessment in accordance with its internal Speaker Program Policy and applicable compliance procedures, and has determined that Speaker's services are necessary and appropriate to achieve the educational objectives described in this Agreement;

WHEREAS, the Parties intend for this Agreement and all activities conducted hereunder to comply with the federal Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b), and the personal services and management contracts safe harbor set forth at 42 C.F.R. § 1001.952(d), the AdvaMed Code of Ethics on Interactions with U.S. Health Care Professionals (2020 Revision) (the "AdvaMed Code"), and all other applicable federal, state, and local laws, rules, and regulations governing interactions between medical device companies and healthcare professionals; and

WHEREAS, the Parties desire to set forth the terms and conditions under which Speaker will provide speaking services to the Company;

NOW, THEREFORE, in consideration of the mutual covenants and agreements set forth herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:

ARTICLE 1 — DEFINITIONS

As used in this Agreement, the following terms shall have the meanings set forth below. Capitalized terms used but not defined in this Article 1 shall have the meanings ascribed to them elsewhere in this Agreement.

1.1 "Approved Slide Deck" means the presentation materials prepared, reviewed, and approved by the Company's Medical-Legal-Regulatory (MLR) Committee for use in Speaker Programs, including all slides, speaker notes, and supplemental handouts expressly designated as part of the Approved Slide Deck. The Approved Slide Deck may be updated from time to time by the Company in its sole discretion, and any such updated version shall supersede all prior versions upon notification to Speaker.

1.2 "Cleared Indications" means the indications for use of the Pulsar™ CRM System as set forth in the FDA 510(k) clearance documentation (510(k) No. K232847), specifically: continuous cardiac rhythm monitoring in adult patients with suspected or documented cardiac arrhythmias. The Cleared Indications do not include any use, patient population, clinical application, or indication not expressly described in the FDA-cleared labeling.

1.3 "Compliance Officer" means the Company's designated United States Compliance Officer, currently Siobhán Mulcahy, Head of Global Compliance (serving in an interim capacity as US Compliance Officer), or such successor or replacement as the Company may designate from time to time by written notice to Speaker.

1.4 "Covered Recipient" has the meaning ascribed to such term under the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h) and the implementing regulations promulgated by the Centers for Medicare & Medicaid Services ("CMS") at 42 C.F.R. Part 403, Subpart I, and includes, without limitation, physicians and teaching hospitals as defined therein.

1.5 "Healthcare Professional" or "HCP" means any physician (M.D. or D.O.), nurse practitioner, physician assistant, registered nurse, or other individual who is licensed, certified, or otherwise authorized under applicable state law to provide healthcare services and who is in a position to order, recommend, prescribe, purchase, lease, or arrange for the purchase or lease of medical devices, including the Pulsar™ CRM System.

1.6 "Live Program" means a Speaker Program conducted in person at a pre-approved venue in accordance with the requirements of Article 7 of this Agreement.

1.7 "Off-Label Use" means any use, application, indication, dosing regimen, patient population, or clinical scenario for the Pulsar™ CRM System that is outside the scope of, inconsistent with, or not described in the Cleared Indications as set forth in the FDA-cleared labeling.

1.8 "Open Payments" means the CMS transparency reporting program established pursuant to the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), through which applicable manufacturers and applicable group purchasing organizations report certain payments and other transfers of value made to Covered Recipients.

1.9 "Program Coordinator" means the Company employee or authorized representative designated by the Company to organize, oversee, and document a particular Speaker Program event, including responsibility for logistics, attendee verification, and completion of the Program Completion Form (Exhibit F).

1.10 "Speaker Program" means a Company-sponsored educational presentation delivered by Speaker to an audience composed primarily of Healthcare Professionals, addressing the Pulsar™ CRM System, its clinical applications within the Cleared Indications, implantation techniques, remote monitoring capabilities, clinical evidence, and related topics, all as set forth in the Approved Slide Deck. Speaker Programs may be conducted as Live Programs or Virtual Programs.

1.11 "Speaker Training" means the mandatory compliance, product knowledge, and presentation skills training program that Speaker must successfully complete before delivering any Speaker Program, as more fully described in Article 4 of this Agreement.

1.12 "Term" has the meaning set forth in Section 10.1 of this Agreement.

1.13 "Virtual Program" means a Speaker Program conducted remotely via a Company-approved web-based videoconference, webinar, or teleconference platform, as designated by the Company for each such program.

ARTICLE 2 — ENGAGEMENT AND SCOPE OF SERVICES

2.1 Engagement. The Company hereby engages Speaker, and Speaker hereby accepts the engagement, to serve as a speaker at Company-sponsored Speaker Programs during the Term, subject to and in accordance with the terms and conditions of this Agreement. Speaker's engagement is non-exclusive, and nothing in this Agreement shall prevent the Company from engaging other speakers or prevent Speaker from engaging in other professional activities that do not conflict with this Agreement.

2.2 Scope of Services. During the Term, Speaker shall perform the following services in connection with Speaker Programs:

(a) Deliver presentations at Speaker Programs using only the Approved Slide Deck provided by the Company, without modification, addition, deletion, rearrangement, or supplementation of any content, slides, data, images, or claims, unless such modification has been expressly approved in advance and in writing by the Company's MLR Committee;

(b) Respond to audience questions during and immediately following Speaker Programs in a manner that is consistent with and limited to the Cleared Indications, the Approved Slide Deck, and the FDA-cleared product labeling for the Pulsar™ CRM System, and in compliance with the content restrictions set forth in Article 8;

(c) Successfully complete Speaker Training, including all required modules and the certification quiz, prior to delivering any Speaker Program, as described in Article 4;

(d) Cooperate with the Company and the designated Program Coordinator in all aspects of scheduling, logistics, venue arrangements, attendee communications, and post-program documentation, including the timely completion and submission of Program Completion Forms (Exhibit F), attendee sign-in sheets, program evaluation forms, and such other documentation as the Company may reasonably require;

(e) Comply with all applicable federal, state, and local laws, rules, regulations, and guidance in the performance of services under this Agreement, including without limitation the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), the federal False Claims Act (31 U.S.C. §§ 3729–3733), FDA regulations governing the promotion and advertising of Class II medical devices (21 C.F.R. Parts 801, 807, and 820, as applicable), the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the AdvaMed Code of Ethics on Interactions with U.S. Health Care Professionals (2020 Revision), and all applicable state transparency reporting and marketing code requirements.

2.3 Independent Contractor Status. Speaker is, and at all times during the Term shall remain, an independent contractor of the Company. Nothing in this Agreement shall be construed to create an employer-employee relationship, partnership, joint venture, or agency relationship between the Company and Speaker. Speaker shall have no authority to bind the Company, enter into contracts on behalf of the Company, or represent Speaker as an employee or agent of the Company to any third party. Speaker shall be solely responsible for all federal, state, and local income taxes, self-employment taxes, Social Security and Medicare taxes, and any other taxes or withholdings applicable to compensation received under this Agreement. Speaker shall maintain, at Speaker's own expense, all professional licenses, certifications, malpractice insurance, and other insurance required for Speaker's medical practice and professional activities.

2.4 Estimated Number of Programs. During the Term, the Company anticipates requesting Speaker to present at approximately [Insert Number] Speaker Programs, which may include a combination of Live Programs and Virtual Programs. The Parties acknowledge and agree that this estimate is provided for planning purposes only. The Company is under no obligation to request any minimum number of Speaker Programs, and Speaker is under no obligation to accept any particular speaking engagement. The scheduling and frequency of Speaker Programs shall be at the Company's sole discretion and shall be subject to the needs-assessment and pre-approval process described in Article 3. Speaker's compensation shall be based solely on the number of Speaker Programs actually delivered, as set forth in Article 5.

ARTICLE 3 — NEEDS ASSESSMENT AND PROGRAM APPROVAL

3.1 Legitimate Business Need Requirement. Each individual Speaker Program must be supported by a documented legitimate business need assessment, prepared by a member of the Company's US Commercial Operations team or Medical Affairs department, and approved by the Compliance Officer (or the Compliance Officer's designee) prior to scheduling the program or extending any invitation to Speaker. The legitimate business need assessment is intended to ensure that each Speaker Program serves a bona fide educational purpose, is targeted to an appropriate audience, and is not used as a mechanism to provide compensation to Speaker in excess of what is warranted by the Company's genuine educational needs.

3.2 Needs-Assessment Documentation. For each proposed Speaker Program, the requesting Company employee must complete a Needs-Assessment Form in the form attached hereto as Exhibit D. The Needs-Assessment Form must include, at a minimum, the following information:

(a) Identification of the target audience for the program, including the relevant medical specialty or specialties, geographic region, and practice setting (e.g., hospital-based, office-based, academic medical center);

(b) A clear statement of the educational objective of the program, which must be directly aligned with one or more of the Cleared Indications for the Pulsar™ CRM System;

(c) Justification for the selection of Speaker for the particular program, including a description of Speaker's relevant clinical expertise, geographic proximity or relevance to the target audience, and, if available, prior speaker evaluation scores or feedback;

(d) Confirmation that the proposed program is not duplicative of recent Speaker Programs conducted in the same geographic territory or targeting the same audience, and if there is potential overlap, a written explanation of why the proposed program is nonetheless warranted;

(e) The expected number of attendees, which must comply with the audience size limitations set forth in Section 3.4;

(f) The proposed venue name, address, and type, together with confirmation that the venue satisfies the requirements of Article 7;

(g) The proposed date and time of the program.

3.3 Pre-Approval. No Speaker Program shall be scheduled, no venue shall be reserved, and no invitation shall be extended to Speaker or to prospective attendees, until the Needs-Assessment Form has been fully completed by the requesting Company employee and approved in writing (which may include electronic approval via the Company's compliance management platform) by the Compliance Officer or the Compliance Officer's authorized designee. Verbal approvals, informal email approvals without use of the designated approval workflow, and retroactive approvals are not sufficient and will not be accepted. Any Speaker Program conducted without a properly completed and pre-approved Needs-Assessment Form shall constitute a violation of Company policy and may result in disciplinary action against the responsible Company employee.

3.4 Audience Requirements. The following requirements apply to the audience for each Speaker Program:

(a) All attendees must be Healthcare Professionals who have a bona fide professional interest in cardiac rhythm management, cardiac monitoring, electrophysiology, or a related clinical discipline. Attendees who are not HCPs, or who do not have a legitimate professional interest in the subject matter, may not attend;

(b) The maximum audience size for any single Speaker Program shall not exceed [Insert Cap — e.g., 25 attendees] for Live Programs and [Insert Cap — e.g., 50 attendees] for Virtual Programs. Audience sizes exceeding these caps require prior written approval from the Compliance Officer;

(c) Non-HCP guests, spouses, partners, family members, and "plus-ones" are strictly prohibited from attending any Speaker Program, regardless of the venue or format;

(d) Repeat attendance by the same HCP at the same Speaker Program (i.e., a program using the same or substantially similar Approved Slide Deck content) is strongly discouraged and must be documented on the Program Completion Form (Exhibit F) with a written justification for why the repeat attendance was appropriate. Patterns of repeat attendance by the same HCPs may trigger a compliance review.

ARTICLE 4 — SPEAKER TRAINING PREREQUISITE

4.1 Mandatory Training. Prior to delivering any Speaker Program under this Agreement, Speaker must successfully complete the Company's Speaker Training program in its entirety. The Speaker Training program is designed to ensure that Speaker has a thorough understanding of the Pulsar™ CRM System, the applicable regulatory and compliance framework, and the Company's expectations regarding on-label content delivery. The Speaker Training program includes the following components:

(a) Product Training: Comprehensive training on the Pulsar™ CRM System, including its cleared indications, mechanism of action, device features and specifications, implantation procedure, remote telemetry platform functionality, published clinical data and evidence, patient selection criteria, and competitive landscape overview (within the parameters approved by the MLR Committee);

(b) Compliance Training: Detailed training covering the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)) and the personal services safe harbor (42 C.F.R. § 1001.952(d)), the federal False Claims Act (31 U.S.C. §§ 3729–3733), FDA promotional and advertising regulations applicable to Class II medical devices, the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h) and Open Payments reporting requirements, the AdvaMed Code of Ethics on Interactions with U.S. Health Care Professionals (2020 Revision), and the specific compliance obligations set forth in this Agreement;

(c) Presentation Skills and Approved Slide Deck Walkthrough: A guided walkthrough of the current Approved Slide Deck, including instruction on presentation delivery, key messaging, speaker notes, fair balance requirements, and techniques for handling audience questions, including questions that may involve Off-Label Use;

(d) Certification Quiz: A written or electronic certification quiz covering the material presented in the Product Training, Compliance Training, and Approved Slide Deck walkthrough modules. Speaker must achieve a minimum passing score of [Insert — e.g., 80%] to successfully complete the Speaker Training program. Speakers who do not achieve the minimum passing score on the first attempt may retake the quiz one additional time. Failure to achieve the minimum passing score after two attempts shall result in disqualification from the speaker program.

4.2 Training Completion Certificate. Speaker Training shall not be considered complete, and Speaker shall not be authorized to deliver any Speaker Program, until Speaker has executed the Training Completion Certificate in the form attached hereto as Exhibit E. The Training Completion Certificate memorializes the date(s) of training completion, the modules completed, the certification quiz score achieved, and Speaker's attestation that Speaker understands the content restrictions, compliance requirements, and reporting obligations applicable to Speaker's role under this Agreement. The Company shall retain a copy of the fully executed Training Completion Certificate in its compliance files for the duration of the Agreement and for a minimum of seven (7) years thereafter.

4.3 Refresher Training. If the Approved Slide Deck is materially updated by the Company's MLR Committee — including but not limited to updates reflecting new clinical data, changes to cleared indications, modifications to safety information, or changes to approved messaging — Speaker must complete a refresher training session covering the updated materials before presenting the revised Approved Slide Deck at any Speaker Program. The Company will provide Speaker with reasonable advance notice of material updates and will make the refresher training available in a format (in-person, virtual, or self-directed) reasonably convenient for Speaker. Speaker shall not present any updated Approved Slide Deck until the refresher training has been completed and documented.

4.4 No Compensation for Training. Speaker shall not receive honoraria or any other form of compensation for attending or completing Speaker Training sessions, including initial training, refresher training, or any remedial training. However, if the Company requires Speaker to attend an in-person training session that necessitates travel, the Company may reimburse Speaker for reasonable travel expenses incurred in connection with such in-person training in accordance with the expense reimbursement provisions of Article 6 of this Agreement, subject to the same documentation and pre-approval requirements applicable to Speaker Program-related expenses.

ARTICLE 5 — COMPENSATION

5.1 Honoraria. As full compensation for Speaker's services in delivering Speaker Programs under this Agreement, the Company shall pay Speaker the following honoraria:

(a) Live Program: Speaker shall receive an honorarium of One Thousand Five Hundred Dollars ($1,500.00) per Live Program delivered in accordance with the terms of this Agreement.

(b) Virtual Program: Speaker shall receive an honorarium of Seven Hundred Fifty Dollars ($750.00) per Virtual Program delivered in accordance with the terms of this Agreement.

The honoraria rates are set forth in the Compensation Schedule attached hereto as Exhibit B and incorporated herein by reference.

5.2 Annual Per-Speaker Cap. Notwithstanding anything in this Agreement to the contrary, the total aggregate honoraria payable to Speaker under this Agreement shall not exceed Eighteen Thousand Dollars ($18,000.00) in any single calendar year (the "Annual Cap"). The Annual Cap applies cumulatively across all program types (Live Programs and Virtual Programs combined). Once the Annual Cap has been reached in a given calendar year, the Company shall not schedule or request additional Speaker Programs from Speaker during the remainder of that calendar year, and Speaker shall not be entitled to receive any additional honoraria for that calendar year. For partial calendar years (e.g., if the Effective Date falls mid-year or if the Agreement terminates mid-year), the Annual Cap shall not be prorated and shall apply in full.

5.3 Fair Market Value. The Parties acknowledge and agree that the honoraria rates set forth in Section 5.1 represent fair market value for the speaking services rendered by Speaker under this Agreement, as determined by an independent third-party valuation and benchmarking analysis conducted by the Company. The compensation has been established based on objective criteria, including the nature and complexity of the services, the time required, the qualifications of the speaker, and prevailing market rates for comparable speaking engagements in the medical device industry. The Parties further acknowledge and agree that the honoraria are not intended to, and do not, take into account the volume or value of any referrals, orders, purchases, leases, or business generated by Speaker for the Company or any affiliate of the Company, and are not intended to induce or reward the referral of patients, the ordering or recommending of any product, or the generation or arranging of any business reimbursable under any federal healthcare program, including Medicare, Medicaid, TRICARE, or any other government-funded health insurance program.

5.4 Payment Terms. Honoraria shall be paid within thirty (30) calendar days of the Company's receipt of the following documentation:

(i) a fully completed Program Completion Form (Exhibit F) signed by the designated Program Coordinator, confirming that the Speaker Program was delivered in compliance with this Agreement and Company policies; and

(ii) Speaker's invoice or, if not previously provided, a completed IRS Form W-9 (Request for Taxpayer Identification Number and Certification).

Payment shall be made by Company check mailed to the address designated by Speaker or by electronic funds transfer to a bank account designated by Speaker in writing. The Company shall not be obligated to make any payment until both items described in clauses (i) and (ii) above have been received and verified by the Company. Incomplete or inaccurate Program Completion Forms will be returned to the Program Coordinator for correction, which may delay payment.

5.5 No Additional Compensation. Except as expressly provided in this Article 5 (Compensation) and Article 6 (Expenses and Meals), Speaker shall not receive any other compensation, payment, benefit, remuneration, or thing of value from the Company in connection with Speaker's engagement or services under this Agreement. Without limiting the generality of the foregoing, the Company shall not provide Speaker with gifts, grants, free or discounted products, equipment, supplies, charitable donations made at Speaker's request, research funding conditioned on Speaker's participation in the speaker program, or promotional items of value in connection with this Agreement or Speaker's participation in any Speaker Program.

5.6 Tax Reporting. The Company will report all payments made to Speaker under this Agreement in accordance with all applicable Internal Revenue Service ("IRS") requirements, including the issuance of IRS Form 1099-NEC (Nonemployee Compensation) or IRS Form 1099-MISC (Miscellaneous Information), as applicable, for each calendar year in which payments are made. Speaker is solely responsible for the payment of all federal, state, and local taxes on compensation received under this Agreement and acknowledges that the Company will not withhold any taxes from payments made to Speaker.

ARTICLE 6 — EXPENSES AND MEALS

6.1 Reimbursable Expenses. For Live Programs that require Speaker to travel away from Speaker's principal practice location, the Company may reimburse Speaker for reasonable, documented, and pre-approved out-of-pocket travel expenses actually incurred by Speaker in direct connection with the Speaker Program. Reimbursable expenses are limited to the following categories:

(a) Airfare: Economy-class (coach) airfare by the most direct available route. Business-class or first-class airfare is not reimbursable. In lieu of airfare, Speaker may claim standard mileage reimbursement at the then-current IRS standard mileage rate for business use of a personal vehicle (currently $0.67 per mile for 2024);

(b) Hotel Accommodations: Lodging at a standard business-class hotel for the night(s) reasonably necessary to attend and deliver the Speaker Program. Resort properties, luxury hotels, boutique hotels with rates substantially exceeding standard business-class rates, and hotel room upgrades are not reimbursable;

(c) Ground Transportation: Reasonable ground transportation expenses, including taxi fare, ride-share services (e.g., Uber, Lyft), airport shuttle services, and rental car charges (economy or mid-size class only), including fuel for rental vehicles;

(d) Meals During Travel: Reasonable meal expenses incurred by Speaker while traveling to and from the Speaker Program venue, subject to the per-person meal cap set forth in Section 6.2 below.

6.2 Meal and Hospitality Cap. Meals and refreshments provided in connection with any Speaker Program — whether provided to Speaker, to attendees, or to Company personnel — shall not exceed One Hundred Fifty Dollars ($150.00) per person per event, inclusive of tax, gratuity, and service charges, in alignment with the AdvaMed Code of Ethics on Interactions with U.S. Health Care Professionals (2020 Revision) and the Company's internal policies. This per-person cap applies individually to each person who receives a meal or refreshments in connection with the Speaker Program. Alcoholic beverages are strictly prohibited at all Company-sponsored Speaker Programs and may not be purchased, served, offered, or reimbursed under any circumstances, regardless of whether the cost would fall within the per-person cap.

6.3 Expense Documentation. Speaker must submit a completed Expense Reimbursement Form (Exhibit G) together with itemized receipts for all reimbursable expenses within fourteen (14) calendar days following the date of the applicable Speaker Program. Expenses submitted without adequate supporting documentation, without itemized receipts, in excess of applicable category limits or per-person caps, or after the fourteen (14) day submission deadline will not be reimbursed. The Company reserves the right to request additional documentation or clarification regarding any submitted expense. Reimbursement requests are subject to review and approval by the Compliance Officer or designee.

6.4 No Spouse/Guest Travel. The Company shall not reimburse, and Speaker shall not submit requests for reimbursement of, any travel, lodging, meal, or other expenses incurred by or on behalf of Speaker's spouse, domestic partner, family members, companions, or other guests, regardless of whether such individuals accompany Speaker to the Speaker Program venue. Any such expenses are the sole financial responsibility of Speaker.

ARTICLE 7 — VENUE REQUIREMENTS AND RESTRICTIONS

7.1 Approved Venues. Speaker Programs shall be held only at venues that are conducive to a professional, educational setting and that are selected based on their suitability for the educational objectives of the program rather than for entertainment, recreational, or social purposes. Approved venue types include, without limitation:

(a) Hospital or healthcare facility conference rooms, auditoriums, or meeting spaces;

(b) Medical office settings, including physician group practice conference rooms and ambulatory care facility meeting rooms;

(c) Hotels with dedicated meeting or conference room facilities (excluding resort properties as described in Section 7.2 below), where the meeting room is the primary purpose for venue selection;

(d) Restaurant private dining rooms, suitable for modest meal programs where the educational presentation is the primary purpose of the event and the meal is incidental and subordinate to the educational component.

7.2 Prohibited Venues. Speaker Programs shall not be held at any venue that falls within the following categories, and the Company will not approve any Needs-Assessment Form proposing such a venue:

(a) Entertainment or recreational venues, including without limitation sporting event venues (stadiums, arenas, racetracks), theaters, concert halls, amusement parks, theme parks, golf courses, country clubs, ski resorts, bowling alleys, or similar establishments;

(b) Resort hotels, resort-style properties, or destination resorts, including any property that markets itself primarily as a resort, spa, or vacation destination;

(c) Bars, nightclubs, lounges, breweries, wineries, distilleries, or similar establishments where the primary business activity is the service of alcoholic beverages;

(d) Any other venue selected primarily for its entertainment, recreational, scenic, or luxury characteristics rather than its suitability as an educational meeting space.

7.3 Venue Pre-Approval. All proposed venues must be identified and pre-approved as part of the needs-assessment process described in Article 3 of this Agreement. The venue name, address, venue type, and confirmation that the venue does not fall within any prohibited category must be documented on the Needs-Assessment Form (Exhibit D) and approved by the Compliance Officer or designee before the venue is reserved or any invitations are issued. If circumstances require a change of venue after initial approval, the revised venue must be separately pre-approved through the same process.

ARTICLE 8 — CONTENT RESTRICTIONS AND PROMOTIONAL COMPLIANCE

8.1 Approved Slide Deck Only. Speaker shall use only the current version of the Approved Slide Deck provided by the Company for each Speaker Program. Speaker acknowledges that the Approved Slide Deck has been prepared and reviewed by the Company's MLR Committee to ensure compliance with FDA regulations, the Cleared Indications, and the Company's promotional review standards. Speaker shall not modify, supplement, rearrange, annotate, add slides to, delete slides from, or otherwise deviate from the Approved Slide Deck in any manner without prior written authorization from the Company's MLR Committee. Any unauthorized modification of the Approved Slide Deck shall constitute a material breach of this Agreement.

8.2 On-Label Presentations Only. All presentations delivered by Speaker at Speaker Programs, including all oral remarks, visual presentations, responses to audience questions, and informal discussions with attendees before, during, and after the formal presentation, must be limited to the Cleared Indications of the Pulsar™ CRM System — specifically, continuous cardiac rhythm monitoring in adult patients with suspected or documented cardiac arrhythmias — as described in the FDA 510(k) clearance (No. K232847) and the FDA-cleared product labeling. Speaker shall not discuss, promote, endorse, suggest, or imply any Off-Label Use of the Pulsar™ CRM System, including without limitation use in pediatric patients, use for indications not described in the cleared labeling, or use in clinical scenarios outside the approved patient population.

8.3 Prohibition on Off-Label Discussion. Speaker acknowledges that attendees at Speaker Programs may ask questions that touch upon or require discussion of Off-Label Uses of the Pulsar™ CRM System. In the event that an attendee poses such a question, Speaker shall adhere to the following protocol:

(a) Speaker shall politely decline to address the off-label question during the Speaker Program, explaining that Speaker is not authorized to discuss uses outside the FDA-cleared indications in the context of a Company-sponsored program;

(b) Speaker shall direct the attendee to the Company's Medical Affairs department for any unsolicited medical information requests regarding off-label topics. The primary Medical Affairs contact for such inquiries is Dr. Nadia Farouk, Vice President, Medical Affairs, Solstice Biomedical Inc. The Program Coordinator will provide attendees with appropriate contact information upon request;

(c) Speaker shall document the off-label question on the Program Completion Form (Exhibit F), including a brief description of the question asked and confirmation that the question was redirected to Medical Affairs.

8.4 Fair Balance. All presentations delivered by Speaker must include a fair and balanced presentation of both the benefits and the risks associated with the Pulsar™ CRM System, consistent with the product labeling, the FDA-cleared indications, and applicable FDA requirements for the promotion of Class II medical devices. Speaker shall not overemphasize the benefits of the device while minimizing or omitting known risks, warnings, precautions, contraindications, or adverse events described in the product labeling. The Approved Slide Deck contains fair balance information that must be presented in its entirety during each Speaker Program.

8.5 No Comparative Claims. Speaker shall not make any unapproved comparative claims, either express or implied, regarding the Pulsar™ CRM System relative to competing products, including but not limited to the predicate device referenced in the Company's 510(k) submission (510(k) No. K201156) or any other subcutaneous implantable cardiac monitor or cardiac rhythm management device on the market. Comparative claims may only be presented if they are expressly included in the current version of the Approved Slide Deck, as reviewed and approved by the Company's MLR Committee, and are supported by adequate substantiation.

8.6 No Guarantees. Speaker shall not make any guarantees, warranties, promises, or assurances regarding the performance, efficacy, clinical outcomes, reliability, durability, or results of the Pulsar™ CRM System that go beyond what is stated in the Approved Slide Deck and the FDA-cleared product labeling. Speaker shall not represent or imply that the Pulsar™ CRM System will achieve any specific clinical result for any individual patient.

ARTICLE 9 — COMPLIANCE OBLIGATIONS

9.1 Anti-Kickback Statute Compliance. Speaker acknowledges that this Agreement is structured and intended to comply with the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)) and, in particular, with the personal services and management contracts safe harbor set forth at 42 C.F.R. § 1001.952(d). Speaker acknowledges that the Anti-Kickback Statute prohibits the knowing and willful solicitation, receipt, offer, or payment of any remuneration (including any kickback, bribe, or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward referrals for, or the ordering, purchasing, leasing, or arranging for the ordering, purchasing, or leasing of, any item or service reimbursable under any federal healthcare program. Speaker agrees that no part of the compensation paid under this Agreement is intended to, or does, induce or reward the referral of patients, the ordering or purchasing of any product (including the Pulsar™ CRM System or any other Solstice product), or the generation or arrangement of any business reimbursable under Medicare, Medicaid, TRICARE, or any other federal healthcare program.

9.2 False Claims Act. Speaker shall not, in connection with any Speaker Program or any other activity under this Agreement, make any false, misleading, inaccurate, or fraudulent statement, claim, or representation regarding the Pulsar™ CRM System, its cleared indications, its clinical performance, its coverage or reimbursement status under any federal or state healthcare program, its coding (including CPT, ICD-10, or HCPCS codes), or any other matter. Speaker acknowledges that false or misleading statements may give rise to liability under the federal False Claims Act (31 U.S.C. §§ 3729–3733) and analogous state false claims statutes, and that violations may result in significant civil and criminal penalties.

9.3 AdvaMed Code. The Parties agree that this Agreement and all activities conducted hereunder shall comply in all respects with the AdvaMed Code of Ethics on Interactions with U.S. Health Care Professionals (2020 Revision), including without limitation the provisions relating to consultant arrangements, compensation at fair market value, needs assessments, venue selection, meals and hospitality, and educational programs. In the event of any conflict between the provisions of this Agreement and the AdvaMed Code, the more restrictive provision shall control.

9.4 State Law Compliance. Speaker acknowledges that various states have enacted laws and regulations that impose additional requirements and restrictions on interactions between medical device companies and healthcare professionals, which may include, without limitation, gift bans or gift limitations, aggregate spend reporting and transparency requirements, marketing code of conduct adoption mandates, and registration or licensing requirements for pharmaceutical and medical device representatives. Speaker agrees to cooperate with the Company in identifying and complying with all state laws and regulations applicable to Speaker's activities under this Agreement, including by providing information necessary for the Company to comply with state transparency reporting obligations. Speaker shall promptly notify the Company if Speaker becomes aware of any state law or regulation that may affect Speaker's eligibility to participate in, or the Company's ability to conduct, Speaker Programs in any particular jurisdiction.

9.5 No Referral Obligation. Nothing in this Agreement shall be construed to require, obligate, or incentivize Speaker to order, recommend, prescribe, purchase, lease, use, or arrange for the ordering, recommending, prescribing, purchasing, leasing, or use of the Pulsar™ CRM System or any other Solstice product, either during the Term or at any time thereafter. Speaker's compensation under this Agreement is fixed, is based solely on the fair market value of the speaking services rendered, and is in no way conditioned upon, influenced by, or correlated with any volume or value of referrals, orders, purchases, or other business generated by Speaker for the Company or any affiliate of the Company.

9.6 Compliance Certifications. Speaker shall execute the Compliance Certification in the form attached hereto as Exhibit C concurrently with the execution of this Agreement. Thereafter, during the Term of this Agreement, Speaker shall execute a new Compliance Certification on an annual basis, on or before the anniversary of the Effective Date. The Company may also request that Speaker execute an updated Compliance Certification at any time upon reasonable notice if there has been a material change in applicable law, regulation, or Company policy. Failure to timely execute a required Compliance Certification shall constitute grounds for suspension of Speaker's engagement pending completion of the certification.

9.7 Government Exclusion. Speaker represents and warrants that, as of the Effective Date and at all times during the Term of this Agreement:

(a) Speaker is not excluded, debarred, or suspended from participation in any federal healthcare program, including Medicare, Medicaid, and TRICARE;

(b) Speaker is not listed on the U.S. Department of Health and Human Services, Office of Inspector General ("OIG") List of Excluded Individuals/Entities ("LEIE"), the U.S. General Services Administration System for Award Management ("SAM") Exclusions database, or any equivalent state exclusion list;

(c) Speaker is not subject to any pending investigation, proceeding, or action by any federal, state, or local governmental authority that could reasonably be expected to result in Speaker's exclusion, debarment, or suspension from any federal healthcare program.

Speaker agrees to notify the Company immediately, and in no event later than five (5) business days, upon learning of any event, investigation, proceeding, or action that could result in Speaker's exclusion, debarment, or suspension from any federal healthcare program. The Company reserves the right to verify Speaker's exclusion status at any time during the Term by searching the OIG LEIE, the SAM Exclusions database, and applicable state exclusion databases, and Speaker consents to such verification.

9.8 Compliance Hotline. The Company maintains an anonymous compliance reporting hotline operated by Clearpath Ethics Services Inc., an independent third-party compliance services provider. Speaker, Company employees, and any other individual may report concerns regarding potential violations of law, regulation, Company policy, or the terms of this Agreement, including concerns related to the Anti-Kickback Statute, the False Claims Act, off-label promotion, or any other compliance matter. Reports may be made anonymously and without fear of retaliation by calling the hotline at [Insert Hotline Number] or by accessing the secure web reporting portal at [Insert URL]. The Company prohibits retaliation against any individual who makes a good-faith report of a compliance concern.

ARTICLE 10 — TERM AND TERMINATION

10.1 Term. This Agreement shall be effective as of the Effective Date and shall continue for a period of [Insert — e.g., one (1) year] from the Effective Date, unless earlier terminated in accordance with the provisions of this Article 10 (the "Term"). Upon expiration of the initial Term, this Agreement may be renewed for additional successive periods of [Insert — e.g., one (1) year] each upon the mutual written agreement of both Parties. Any renewal shall be documented in a written amendment or renewal notice signed by both Parties at least thirty (30) days prior to the expiration of the then-current Term. Each renewal period shall be subject to a renewed needs assessment and fair market value confirmation in accordance with Company policy.

10.2 Termination for Convenience. Either Party may terminate this Agreement at any time, with or without cause, upon [Insert — e.g., thirty (30)] days' prior written notice to the other Party. Written notice of termination for convenience shall be delivered in accordance with Section 16.7 of this Agreement.

10.3 Termination for Cause. The Company may terminate this Agreement immediately upon written notice to Speaker, without any requirement for a cure period, if any of the following events occurs:

(a) Speaker breaches any provision of Article 8 (Content Restrictions and Promotional Compliance) or Article 9 (Compliance Obligations), including but not limited to any modification of the Approved Slide Deck, promotion of Off-Label Use, or failure to comply with the Anti-Kickback Statute or the AdvaMed Code;

(b) Speaker is excluded, debarred, or suspended from participation in any federal or state healthcare program, or is listed on the OIG LEIE, the SAM Exclusions database, or any equivalent state exclusion list;

(c) Speaker loses, or has suspended, revoked, restricted, or surrendered, any medical license, DEA registration, or other professional license or certification required for Speaker's practice of medicine or delivery of Speaker Programs;

(d) Speaker engages in conduct that, in the Company's sole and reasonable judgment, creates a material compliance risk, legal risk, or reputational risk to the Company, including but not limited to conduct involving fraud, dishonesty, moral turpitude, substance abuse, patient safety concerns, or public statements inconsistent with the Company's values or compliance program;

(e) Speaker fails to complete or pass Speaker Training, any required refresher training, or any required Compliance Certification within the time frames established by the Company;

(f) Speaker violates any applicable federal, state, or local law, regulation, or professional ethical standard in connection with Speaker's performance under this Agreement.

10.4 Effect of Termination. Upon the effective date of termination or expiration of this Agreement, regardless of the reason:

(a) Speaker shall immediately cease all activities under this Agreement, including the delivery of any scheduled but not yet completed Speaker Programs;

(b) The Company shall pay Speaker for any Speaker Programs that were completed prior to the effective date of termination and for which payment has not yet been made, subject to submission of a completed Program Completion Form (Exhibit F) and compliance with the payment terms set forth in Section 5.4. For the avoidance of doubt, no honorarium shall be payable for any Speaker Program scheduled but not delivered as of the effective date of termination;

(c) Speaker shall promptly return to the Company all Approved Slide Decks (in both physical and electronic form), Company-provided materials, training materials, attendee lists, and any other confidential information or Company property in Speaker's possession or control. Speaker shall permanently delete all electronic copies of such materials from Speaker's computers, devices, and cloud storage accounts and shall certify such deletion in writing upon request by the Company.

10.5 Survival. The following provisions of this Agreement shall survive the expiration or termination of this Agreement for any reason and shall continue in full force and effect thereafter: Article 9 (Compliance Obligations), Article 11 (Physician Payments Sunshine Act / Open Payments Reporting), Article 12 (Confidentiality), Article 13 (Representations and Warranties), Article 14 (Intellectual Property), Article 15 (Indemnification), and Sections 16.1 (Governing Law), 16.5 (Severability), and 16.7 (Notices). The survival of these provisions is necessary to give effect to the Parties' intent with respect to the ongoing obligations described therein and shall not be limited by any statute of limitations applicable to claims arising under this Agreement.

ARTICLE 11 — PHYSICIAN PAYMENTS SUNSHINE ACT / OPEN PAYMENTS REPORTING

11.1 Reporting Obligation. Speaker acknowledges that the Company is an "applicable manufacturer" as defined under the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h) and the implementing regulations promulgated by CMS at 42 C.F.R. Part 403, Subpart I. As an applicable manufacturer, the Company is required by federal law to collect, track, and report to CMS, through the Open Payments system, all payments and other transfers of value made directly or indirectly to Covered Recipients, including physicians such as Speaker.

11.2 Reportable Payments. Speaker acknowledges and expressly consents that the Company will report to CMS all payments and transfers of value made to Speaker under this Agreement, including without limitation honoraria for Speaker Programs, reimbursement of travel expenses (airfare, hotel, ground transportation), meals and refreshments provided in connection with Speaker Programs, and any other items or services of value provided to Speaker, to the extent such payments or transfers of value meet or exceed the applicable CMS reporting thresholds, which are currently set at $12.49 per individual payment or transfer of value, or $100.00 in aggregate per Covered Recipient per calendar year (as indexed for calendar year 2024). Speaker understands that these thresholds are subject to annual adjustment by CMS.

11.3 Data Accuracy. Speaker agrees to provide the Company, upon execution of this Agreement and promptly thereafter upon any change, with accurate, current, and complete information necessary for the Company to fulfill its Open Payments reporting obligations, including without limitation Speaker's full legal name, National Provider Identifier (NPI) number, primary medical specialty, primary practice address (street address, city, state, and ZIP code), and state medical license number(s). Speaker shall promptly notify the Company in writing of any changes to such information during the Term of this Agreement.

11.4 Review Period. Speaker understands that CMS provides an annual review and dispute period during which Covered Recipients may review, and if appropriate, dispute, the accuracy of payment data reported by applicable manufacturers before such data is made publicly available on the CMS Open Payments website. The Company will use commercially reasonable efforts to notify Speaker of the applicable review period and to cooperate with Speaker in resolving any data discrepancies identified by Speaker during the review period.

11.5 Reporting Deadline. For calendar year 2024 transfers of value, the Company is required to submit its Open Payments report to CMS by March 31, 2025. The Company's CMS Manufacturer Identification application for the Open Payments system was submitted in June 2024. Speaker acknowledges that the Company's reporting obligations are ongoing and that data for subsequent calendar years will be reported in accordance with the then-applicable CMS deadlines.

11.6 Consent. By executing this Agreement, Speaker expressly and irrevocably consents to the Company's collection, storage, processing, use, and disclosure of Speaker's personal information (including name, NPI number, specialty, practice address, and state license number) and payment information (including the nature, amount, and date of each payment or transfer of value) as necessary to comply with the Company's Open Payments reporting obligations under the Physician Payments Sunshine Act and implementing regulations. Speaker further acknowledges that reported data will be made publicly available on the CMS Open Payments website and that the Company has no control over the public availability of such data once it has been accepted by CMS.

ARTICLE 12 — CONFIDENTIALITY

12.1 Confidential Information. Speaker agrees to maintain in strict confidence all non-public, proprietary, or confidential information disclosed by the Company to Speaker in connection with this Agreement or Speaker's engagement hereunder (collectively, "Confidential Information"). Confidential Information includes, without limitation, the Company's business strategies, marketing plans, pricing information, customer and distributor information, product pipeline and development information, clinical data and study results not yet published, regulatory submissions, manufacturing processes, financial information and projections, sales data, employee information, trade secrets, and any proprietary content contained in the Approved Slide Deck, training materials, or other Company-provided materials. Speaker shall not disclose, publish, disseminate, or otherwise communicate any Confidential Information to any third party without the prior written consent of the Company, and shall not use any Confidential Information for any purpose other than the performance of Speaker's obligations under this Agreement.

12.2 Exceptions. The confidentiality obligations set forth in Section 12.1 shall not apply to information that:

(a) is or becomes generally available to the public through no act, omission, or fault of Speaker;

(b) was in Speaker's possession prior to disclosure by the Company, as demonstrated by Speaker's written records;

(c) is independently developed by Speaker without reference to, reliance upon, or use of any Confidential Information of the Company, as demonstrated by Speaker's written records; or

(d) is required to be disclosed by applicable law, regulation, court order, subpoena, or other legal process, provided that Speaker shall, to the extent legally permitted, provide the Company with prompt written notice of such required disclosure so that the Company may seek an appropriate protective order or other remedy, and Speaker shall disclose only that portion of the Confidential Information that is legally required to be disclosed.

12.3 Return of Materials. Upon termination or expiration of this Agreement, or at any time upon the Company's written request, Speaker shall promptly return to the Company all documents, materials, files, and media (in both physical and electronic form) containing or embodying Confidential Information, or, at the Company's direction, permanently destroy such materials and certify such destruction in writing to the Company. The obligations set forth in this Article 12 shall survive the expiration or termination of this Agreement for a period of five (5) years.

ARTICLE 13 — REPRESENTATIONS AND WARRANTIES

13.1 Speaker Representations and Warranties. Speaker represents and warrants to the Company, as of the Effective Date and at all times during the Term of this Agreement, as follows:

(a) Speaker holds a current, valid, and unrestricted license to practice medicine in the State(s) of [Insert State(s)] and is in good standing with the applicable state medical board(s);

(b) Speaker possesses the qualifications, training, clinical expertise, and professional experience necessary to deliver Speaker Programs on the Pulsar™ CRM System, including expertise in the field of [Insert Specialty — e.g., electrophysiology, cardiology];

(c) Speaker is not a party to, and Speaker's performance under this Agreement will not violate or conflict with, any other agreement, arrangement, obligation, or understanding (whether written or oral) to which Speaker is a party or by which Speaker is bound;

(d) Speaker is not excluded, debarred, or suspended from participation in any federal or state healthcare program, and is not listed on the OIG LEIE, the SAM Exclusions database, or any equivalent state exclusion list, as more fully described in Section 9.7;

(e) Speaker will disclose to the Company, promptly upon execution of this Agreement and on an ongoing basis during the Term, all financial relationships (including consulting agreements, advisory board memberships, research grants, equity interests, and speaker engagements) that Speaker maintains with competitors of the Company in the cardiac rhythm management device space, including without limitation manufacturers of implantable cardiac monitors, pacemakers, implantable cardioverter-defibrillators, and cardiac resynchronization therapy devices;

(f) All information provided by Speaker to the Company in connection with this Agreement, including information provided for credentialing, needs-ass

SPEAKER PROGRAM AGREEMENT
Solstice Biomedical Inc.
Prepared by
Calderwood & Harkness LLP 1250 Avenue of the Americas, 38th Floor New York, NY 10020
Matter Reference: 1037-00003
Template Version: 1.0 — August 2024
CONFIDENTIAL — ATTORNEY-CLIENT PRIVILEGED WORK PRODUCT
This is a template form agreement. All bracketed fields must be completed for each individual speaker engagement. This template does not constitute a binding agreement until all bracketed fields have been completed, the agreement has been reviewed and approved by the applicable Solstice Biomedical Inc. authorized signatories, and the agreement has been fully executed by both parties.
INTRODUCTORY INSTRUCTIONS / USAGE NOTES
Internal Use Only — Not Part of Agreement
The following instructions are provided for the use of Solstice Biomedical Inc. ("Solstice" or the "Company") personnel and are not intended to be, and shall not be construed as, part of the Speaker Program Agreement itself. These instructions should be removed from the final executed version of each agreement.
Prepared By: This template Speaker Program Agreement has been prepared by Calderwood & Harkness LLP, outside counsel to Solstice Biomedical Inc., for use by the Company's US Commercial Operations team, Medical Affairs department, and the Medical-Legal-Regulatory (MLR) Committee in connection with the engagement of healthcare professional speakers for Company-sponsored educational programs relating to the Pulsar™ CRM System.
Pre-Approval Requirement: All speaker engagements must be pre-approved through the needs-assessment process described in Article 3 of this Agreement before this template is completed and executed. No speaker engagement may proceed without a fully completed and approved Needs-Assessment Form (Exhibit D). The needs-assessment process is a critical compliance safeguard and must not be bypassed under any circumstances.
Authorized Signatories: Completed agreements must be countersigned by one of the following authorized Company representatives:
•  Marcus Reilly, Vice President, US Commercial Operations; or
•  Siobhán Mulcahy, Head of Global Compliance and interim US Compliance Officer; or
•  A designee formally authorized in writing by either Mr. Reilly or Ms. Mulcahy.
No other Company employee is authorized to execute this Agreement on behalf of Solstice Biomedical Inc. without prior written delegation of authority.
Record Retention and Sunshine Act Reporting: All executed agreements, together with all related Exhibits (including Needs-Assessment Forms, Training Completion Certificates, Program Completion Forms, and Expense Reimbursement Forms), must be retained in the compliance file maintained by the Office of the General Counsel for a minimum period of seven (7) years following the expiration or termination of the Agreement. All payments and transfers of value made under executed agreements must be reported through the Company's Sunshine Act tracking system (currently managed through the PharmaClear® platform) in accordance with 42 U.S.C. § 1320a-7h and implementing regulations.
Questions: Questions regarding this template, its use, or the legal and compliance requirements applicable to speaker engagements should be directed to:
•  Office of the General Counsel: Declan Harrington, General Counsel, Solstice Biomedical Inc.
•  Outside Counsel: Joel Strauss or Amy Whitfield, Calderwood & Harkness LLP
Do not modify any substantive provisions of this template without prior consultation with the Office of the General Counsel or outside counsel.
END OF INTRODUCTORY INSTRUCTIONS — REMOVE THIS PAGE BEFORE EXECUTION
SPEAKER PROGRAM AGREEMENT
This Speaker Program Agreement (this "Agreement") is entered into as of [Insert Effective Date] (the "Effective Date"), by and between:
SOLSTICE BIOMEDICAL INC., a Delaware corporation, with its principal offices located at 200 Harborview Drive, Suite 1100, Boston, Massachusetts 02210 (EIN: 93-4718206) (the "Company" or "Solstice"),
and
[Insert Full Legal Name of Speaker], M.D./D.O., an individual with a principal practice address at [Insert Address] (the "Speaker").
The Company and Speaker are each referred to herein individually as a "Party" and collectively as the "Parties."
RECITALS.  WHEREAS, the Company is the United States subsidiary of Solstice Biomedical Devices Ltd., an Irish private limited company, and is engaged in the development, manufacture, and commercialization of innovative medical devices for cardiovascular care, including the Pulsar™ CRM System, a subcutaneous implantable cardiac monitor with an integrated cloud-based remote telemetry platform that has received clearance from the United States Food and Drug Administration ("FDA") pursuant to Section 510(k) of the Federal Food, Drug, and Cosmetic Act (510(k) No. K232847) and is classified as a Class II medical device under Product Code MHX;
WHEREAS, the Pulsar™ CRM System is indicated for continuous cardiac rhythm monitoring in adult patients with suspected or documented cardiac arrhythmias, as set forth in the FDA-cleared labeling;
WHEREAS, the Company desires to engage qualified healthcare professionals to serve as compensated speakers at Company-sponsored educational programs designed to present accurate, balanced, and on-label information regarding the Pulsar™ CRM System, its clinical applications, and related topics to audiences of healthcare professionals;
WHEREAS, Speaker is a physician duly licensed to practice medicine and possessing expertise in the field of [Insert Specialty — e.g., electrophysiology, cardiology, internal medicine with cardiac subspecialty focus], and Speaker has been identified by the Company as a qualified speaker based on a documented legitimate business need consistent with the Company's Speaker Program Policy;
WHEREAS, the Company has conducted a needs assessment in accordance with its internal Speaker Program Policy and applicable compliance procedures, and has determined that Speaker's services are necessary and appropriate to achieve the educational objectives described in this Agreement;
WHEREAS, the Parties intend for this Agreement and all activities conducted hereunder to comply with the federal Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b), and the personal services and management contracts safe harbor set forth at 42 C.F.R. § 1001.952(d), the AdvaMed Code of Ethics on Interactions with U.S. Health Care Professionals (2020 Revision) (the "AdvaMed Code"), and all other applicable federal, state, and local laws, rules, and regulations governing interactions between medical device companies and healthcare professionals; and
WHEREAS, the Parties desire to set forth the terms and conditions under which Speaker will provide speaking services to the Company;
NOW, THEREFORE, in consideration of the mutual covenants and agreements set forth herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:
ARTICLE 1 — DEFINITIONS
As used in this Agreement, the following terms shall have the meanings set forth below. Capitalized terms used but not defined in this Article 1 shall have the meanings ascribed to them elsewhere in this Agreement.
1.1 "Approved Slide Deck" means the presentation materials prepared, reviewed, and approved by the Company's Medical-Legal-Regulatory (MLR) Committee for use in Speaker Programs, including all slides, speaker notes, and supplemental handouts expressly designated as part of the Approved Slide Deck. The Approved Slide Deck may be updated from time to time by the Company in its sole discretion, and any such updated version shall supersede all prior versions upon notification to Speaker.
1.2 "Cleared Indications" means the indications for use of the Pulsar™ CRM System as set forth in the FDA 510(k) clearance documentation (510(k) No. K232847), specifically: continuous cardiac rhythm monitoring in adult patients with suspected or documented cardiac arrhythmias. The Cleared Indications do not include any use, patient population, clinical application, or indication not expressly described in the FDA-cleared labeling.
1.3 "Compliance Officer" means the Company's designated United States Compliance Officer, currently Siobhán Mulcahy, Head of Global Compliance (serving in an interim capacity as US Compliance Officer), or such successor or replacement as the Company may designate from time to time by written notice to Speaker.
1.4 "Covered Recipient" has the meaning ascribed to such term under the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h) and the implementing regulations promulgated by the Centers for Medicare & Medicaid Services ("CMS") at 42 C.F.R. Part 403, Subpart I, and includes, without limitation, physicians and teaching hospitals as defined therein.
1.5 "Healthcare Professional" or "HCP" means any physician (M.D. or D.O.), nurse practitioner, physician assistant, registered nurse, or other individual who is licensed, certified, or otherwise authorized under applicable state law to provide healthcare services and who is in a position to order, recommend, prescribe, purchase, lease, or arrange for the purchase or lease of medical devices, including the Pulsar™ CRM System.
1.6 "Live Program" means a Speaker Program conducted in person at a pre-approved venue in accordance with the requirements of Article 7 of this Agreement.
1.7 "Off-Label Use" means any use, application, indication, dosing regimen, patient population, or clinical scenario for the Pulsar™ CRM System that is outside the scope of, inconsistent with, or not described in the Cleared Indications as set forth in the FDA-cleared labeling.
1.8 "Open Payments" means the CMS transparency reporting program established pursuant to the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), through which applicable manufacturers and applicable group purchasing organizations report certain payments and other transfers of value made to Covered Recipients.
1.9 "Program Coordinator" means the Company employee or authorized representative designated by the Company to organize, oversee, and document a particular Speaker Program event, including responsibility for logistics, attendee verification, and completion of the Program Completion Form (Exhibit F).
1.10 "Speaker Program" means a Company-sponsored educational presentation delivered by Speaker to an audience composed primarily of Healthcare Professionals, addressing the Pulsar™ CRM System, its clinical applications within the Cleared Indications, implantation techniques, remote monitoring capabilities, clinical evidence, and related topics, all as set forth in the Approved Slide Deck. Speaker Programs may be conducted as Live Programs or Virtual Programs.
1.11 "Speaker Training" means the mandatory compliance, product knowledge, and presentation skills training program that Speaker must successfully complete before delivering any Speaker Program, as more fully described in Article 4 of this Agreement.
1.12 "Term" has the meaning set forth in Section 10.1 of this Agreement.
1.13 "Virtual Program" means a Speaker Program conducted remotely via a Company-approved web-based videoconference, webinar, or teleconference platform, as designated by the Company for each such program.
ARTICLE 2 — ENGAGEMENT AND SCOPE OF SERVICES
2.1 Engagement. The Company hereby engages Speaker, and Speaker hereby accepts the engagement, to serve as a speaker at Company-sponsored Speaker Programs during the Term, subject to and in accordance with the terms and conditions of this Agreement. Speaker's engagement is non-exclusive, and nothing in this Agreement shall prevent the Company from engaging other speakers or prevent Speaker from engaging in other professional activities that do not conflict with this Agreement.
2.2 Scope of Services. During the Term, Speaker shall perform the following services in connection with Speaker Programs:
(a) Deliver presentations at Speaker Programs using only the Approved Slide Deck provided by the Company, without modification, addition, deletion, rearrangement, or supplementation of any content, slides, data, images, or claims, unless such modification has been expressly approved in advance and in writing by the Company's MLR Committee;
(b) Respond to audience questions during and immediately following Speaker Programs in a manner that is consistent with and limited to the Cleared Indications, the Approved Slide Deck, and the FDA-cleared product labeling for the Pulsar™ CRM System, and in compliance with the content restrictions set forth in Article 8;
(c) Successfully complete Speaker Training, including all required modules and the certification quiz, prior to delivering any Speaker Program, as described in Article 4;
(d) Cooperate with the Company and the designated Program Coordinator in all aspects of scheduling, logistics, venue arrangements, attendee communications, and post-program documentation, including the timely completion and submission of Program Completion Forms (Exhibit F), attendee sign-in sheets, program evaluation forms, and such other documentation as the Company may reasonably require;
(e) Comply with all applicable federal, state, and local laws, rules, regulations, and guidance in the performance of services under this Agreement, including without limitation the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), the federal False Claims Act (31 U.S.C. §§ 3729–3733), FDA regulations governing the promotion and advertising of Class II medical devices (21 C.F.R. Parts 801, 807, and 820, as applicable), the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the AdvaMed Code of Ethics on Interactions with U.S. Health Care Professionals (2020 Revision), and all applicable state transparency reporting and marketing code requirements.
2.3 Independent Contractor Status. Speaker is, and at all times during the Term shall remain, an independent contractor of the Company. Nothing in this Agreement shall be construed to create an employer-employee relationship, partnership, joint venture, or agency relationship between the Company and Speaker. Speaker shall have no authority to bind the Company, enter into contracts on behalf of the Company, or represent Speaker as an employee or agent of the Company to any third party. Speaker shall be solely responsible for all federal, state, and local income taxes, self-employment taxes, Social Security and Medicare taxes, and any other taxes or withholdings applicable to compensation received under this Agreement. Speaker shall maintain, at Speaker's own expense, all professional licenses, certifications, malpractice insurance, and other insurance required for Speaker's medical practice and professional activities.
2.4 Estimated Number of Programs. During the Term, the Company anticipates requesting Speaker to present at approximately [Insert Number] Speaker Programs, which may include a combination of Live Programs and Virtual Programs. The Parties acknowledge and agree that this estimate is provided for planning purposes only. The Company is under no obligation to request any minimum number of Speaker Programs, and Speaker is under no obligation to accept any particular speaking engagement. The scheduling and frequency of Speaker Programs shall be at the Company's sole discretion and shall be subject to the needs-assessment and pre-approval process described in Article 3. Speaker's compensation shall be based solely on the number of Speaker Programs actually delivered, as set forth in Article 5.
ARTICLE 3 — NEEDS ASSESSMENT AND PROGRAM APPROVAL
3.1 Legitimate Business Need Requirement. Each individual Speaker Program must be supported by a documented legitimate business need assessment, prepared by a member of the Company's US Commercial Operations team or Medical Affairs department, and approved by the Compliance Officer (or the Compliance Officer's designee) prior to scheduling the program or extending any invitation to Speaker. The legitimate business need assessment is intended to ensure that each Speaker Program serves a bona fide educational purpose, is targeted to an appropriate audience, and is not used as a mechanism to provide compensation to Speaker in excess of what is warranted by the Company's genuine educational needs.
3.2 Needs-Assessment Documentation. For each proposed Speaker Program, the requesting Company employee must complete a Needs-Assessment Form in the form attached hereto as Exhibit D. The Needs-Assessment Form must include, at a minimum, the following information:
(a) Identification of the target audience for the program, including the relevant medical specialty or specialties, geographic region, and practice setting (e.g., hospital-based, office-based, academic medical center);
(b) A clear statement of the educational objective of the program, which must be directly aligned with one or more of the Cleared Indications for the Pulsar™ CRM System;
(c) Justification for the selection of Speaker for the particular program, including a description of Speaker's relevant clinical expertise, geographic proximity or relevance to the target audience, and, if available, prior speaker evaluation scores or feedback;
(d) Confirmation that the proposed program is not duplicative of recent Speaker Programs conducted in the same geographic territory or targeting the same audience, and if there is potential overlap, a written explanation of why the proposed program is nonetheless warranted;
(e) The expected number of attendees, which must comply with the audience size limitations set forth in Section 3.4;
(f) The proposed venue name, address, and type, together with confirmation that the venue satisfies the requirements of Article 7;
(g) The proposed date and time of the program.
3.3 Pre-Approval. No Speaker Program shall be scheduled, no venue shall be reserved, and no invitation shall be extended to Speaker or to prospective attendees, until the Needs-Assessment Form has been fully completed by the requesting Company employee and approved in writing (which may include electronic approval via the Company's compliance management platform) by the Compliance Officer or the Compliance Officer's authorized designee. Verbal approvals, informal email approvals without use of the designated approval workflow, and retroactive approvals are not sufficient and will not be accepted. Any Speaker Program conducted without a properly completed and pre-approved Needs-Assessment Form shall constitute a violation of Company policy and may result in disciplinary action against the responsible Company employee.
3.4 Audience Requirements. The following requirements apply to the audience for each Speaker Program:
(a) All attendees must be Healthcare Professionals who have a bona fide professional interest in cardiac rhythm management, cardiac monitoring, electrophysiology, or a related clinical discipline. Attendees who are not HCPs, or who do not have a legitimate professional interest in the subject matter, may not attend;
(b) The maximum audience size for any single Speaker Program shall not exceed [Insert Cap — e.g., 25 attendees] for Live Programs and [Insert Cap — e.g., 50 attendees] for Virtual Programs. Audience sizes exceeding these caps require prior written approval from the Compliance Officer;
(c) Non-HCP guests, spouses, partners, family members, and "plus-ones" are strictly prohibited from attending any Speaker Program, regardless of the venue or format;
(d) Repeat attendance by the same HCP at the same Speaker Program (i.e., a program using the same or substantially similar Approved Slide Deck content) is strongly discouraged and must be documented on the Program Completion Form (Exhibit F) with a written justification for why the repeat attendance was appropriate. Patterns of repeat attendance by the same HCPs may trigger a compliance review.
ARTICLE 4 — SPEAKER TRAINING PREREQUISITE
4.1 Mandatory Training. Prior to delivering any Speaker Program under this Agreement, Speaker must successfully complete the Company's Speaker Training program in its entirety. The Speaker Training program is designed to ensure that Speaker has a thorough understanding of the Pulsar™ CRM System, the applicable regulatory and compliance framework, and the Company's expectations regarding on-label content delivery. The Speaker Training program includes the following components:
(a) Product Training: Comprehensive training on the Pulsar™ CRM System, including its cleared indications, mechanism of action, device features and specifications, implantation procedure, remote telemetry platform functionality, published clinical data and evidence, patient selection criteria, and competitive landscape overview (within the parameters approved by the MLR Committee);
(b) Compliance Training: Detailed training covering the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)) and the personal services safe harbor (42 C.F.R. § 1001.952(d)), the federal False Claims Act (31 U.S.C. §§ 3729–3733), FDA promotional and advertising regulations applicable to Class II medical devices, the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h) and Open Payments reporting requirements, the AdvaMed Code of Ethics on Interactions with U.S. Health Care Professionals (2020 Revision), and the specific compliance obligations set forth in this Agreement;
(c) Presentation Skills and Approved Slide Deck Walkthrough: A guided walkthrough of the current Approved Slide Deck, including instruction on presentation delivery, key messaging, speaker notes, fair balance requirements, and techniques for handling audience questions, including questions that may involve Off-Label Use;
(d) Certification Quiz: A written or electronic certification quiz covering the material presented in the Product Training, Compliance Training, and Approved Slide Deck walkthrough modules. Speaker must achieve a minimum passing score of [Insert — e.g., 80%] to successfully complete the Speaker Training program. Speakers who do not achieve the minimum passing score on the first attempt may retake the quiz one additional time. Failure to achieve the minimum passing score after two attempts shall result in disqualification from the speaker program.
4.2 Training Completion Certificate. Speaker Training shall not be considered complete, and Speaker shall not be authorized to deliver any Speaker Program, until Speaker has executed the Training Completion Certificate in the form attached hereto as Exhibit E. The Training Completion Certificate memorializes the date(s) of training completion, the modules completed, the certification quiz score achieved, and Speaker's attestation that Speaker understands the content restrictions, compliance requirements, and reporting obligations applicable to Speaker's role under this Agreement. The Company shall retain a copy of the fully executed Training Completion Certificate in its compliance files for the duration of the Agreement and for a minimum of seven (7) years thereafter.
4.3 Refresher Training. If the Approved Slide Deck is materially updated by the Company's MLR Committee — including but not limited to updates reflecting new clinical data, changes to cleared indications, modifications to safety information, or changes to approved messaging — Speaker must complete a refresher training session covering the updated materials before presenting the revised Approved Slide Deck at any Speaker Program. The Company will provide Speaker with reasonable advance notice of material updates and will make the refresher training available in a format (in-person, virtual, or self-directed) reasonably convenient for Speaker. Speaker shall not present any updated Approved Slide Deck until the refresher training has been completed and documented.
4.4 No Compensation for Training. Speaker shall not receive honoraria or any other form of compensation for attending or completing Speaker Training sessions, including initial training, refresher training, or any remedial training. However, if the Company requires Speaker to attend an in-person training session that necessitates travel, the Company may reimburse Speaker for reasonable travel expenses incurred in connection with such in-person training in accordance with the expense reimbursement provisions of Article 6 of this Agreement, subject to the same documentation and pre-approval requirements applicable to Speaker Program-related expenses.
ARTICLE 5 — COMPENSATION
5.1 Honoraria. As full compensation for Speaker's services in delivering Speaker Programs under this Agreement, the Company shall pay Speaker the following honoraria:
(a) Live Program: Speaker shall receive an honorarium of One Thousand Five Hundred Dollars ($1,500.00) per Live Program delivered in accordance with the terms of this Agreement.
(b) Virtual Program: Speaker shall receive an honorarium of Seven Hundred Fifty Dollars ($750.00) per Virtual Program delivered in accordance with the terms of this Agreement.
The honoraria rates are set forth in the Compensation Schedule attached hereto as Exhibit B and incorporated herein by reference.
5.2 Annual Per-Speaker Cap. Notwithstanding anything in this Agreement to the contrary, the total aggregate honoraria payable to Speaker under this Agreement shall not exceed Eighteen Thousand Dollars ($18,000.00) in any single calendar year (the "Annual Cap"). The Annual Cap applies cumulatively across all program types (Live Programs and Virtual Programs combined). Once the Annual Cap has been reached in a given calendar year, the Company shall not schedule or request additional Speaker Programs from Speaker during the remainder of that calendar year, and Speaker shall not be entitled to receive any additional honoraria for that calendar year. For partial calendar years (e.g., if the Effective Date falls mid-year or if the Agreement terminates mid-year), the Annual Cap shall not be prorated and shall apply in full.
5.3 Fair Market Value. The Parties acknowledge and agree that the honoraria rates set forth in Section 5.1 represent fair market value for the speaking services rendered by Speaker under this Agreement, as determined by an independent third-party valuation and benchmarking analysis conducted by the Company. The compensation has been established based on objective criteria, including the nature and complexity of the services, the time required, the qualifications of the speaker, and prevailing market rates for comparable speaking engagements in the medical device industry. The Parties further acknowledge and agree that the honoraria are not intended to, and do not, take into account the volume or value of any referrals, orders, purchases, leases, or business generated by Speaker for the Company or any affiliate of the Company, and are not intended to induce or reward the referral of patients, the ordering or recommending of any product, or the generation or arranging of any business reimbursable under any federal healthcare program, including Medicare, Medicaid, TRICARE, or any other government-funded health insurance program.
5.4 Payment Terms. Honoraria shall be paid within thirty (30) calendar days of the Company's receipt of the following documentation:
(i) a fully completed Program Completion Form (Exhibit F) signed by the designated Program Coordinator, confirming that the Speaker Program was delivered in compliance with this Agreement and Company policies; and
(ii) Speaker's invoice or, if not previously provided, a completed IRS Form W-9 (Request for Taxpayer Identification Number and Certification).
Payment shall be made by Company check mailed to the address designated by Speaker or by electronic funds transfer to a bank account designated by Speaker in writing. The Company shall not be obligated to make any payment until both items described in clauses (i) and (ii) above have been received and verified by the Company. Incomplete or inaccurate Program Completion Forms will be returned to the Program Coordinator for correction, which may delay payment.
5.5 No Additional Compensation. Except as expressly provided in this Article 5 (Compensation) and Article 6 (Expenses and Meals), Speaker shall not receive any other compensation, payment, benefit, remuneration, or thing of value from the Company in connection with Speaker's engagement or services under this Agreement. Without limiting the generality of the foregoing, the Company shall not provide Speaker with gifts, grants, free or discounted products, equipment, supplies, charitable donations made at Speaker's request, research funding conditioned on Speaker's participation in the speaker program, or promotional items of value in connection with this Agreement or Speaker's participation in any Speaker Program.
5.6 Tax Reporting. The Company will report all payments made to Speaker under this Agreement in accordance with all applicable Internal Revenue Service ("IRS") requirements, including the issuance of IRS Form 1099-NEC (Nonemployee Compensation) or IRS Form 1099-MISC (Miscellaneous Information), as applicable, for each calendar year in which payments are made. Speaker is solely responsible for the payment of all federal, state, and local taxes on compensation received under this Agreement and acknowledges that the Company will not withhold any taxes from payments made to Speaker.
ARTICLE 6 — EXPENSES AND MEALS
6.1 Reimbursable Expenses. For Live Programs that require Speaker to travel away from Speaker's principal practice location, the Company may reimburse Speaker for reasonable, documented, and pre-approved out-of-pocket travel expenses actually incurred by Speaker in direct connection with the Speaker Program. Reimbursable expenses are limited to the following categories:
(a) Airfare: Economy-class (coach) airfare by the most direct available route. Business-class or first-class airfare is not reimbursable. In lieu of airfare, Speaker may claim standard mileage reimbursement at the then-current IRS standard mileage rate for business use of a personal vehicle (currently $0.67 per mile for 2024);
(b) Hotel Accommodations: Lodging at a standard business-class hotel for the night(s) reasonably necessary to attend and deliver the Speaker Program. Resort properties, luxury hotels, boutique hotels with rates substantially exceeding standard business-class rates, and hotel room upgrades are not reimbursable;
(c) Ground Transportation: Reasonable ground transportation expenses, including taxi fare, ride-share services (e.g., Uber, Lyft), airport shuttle services, and rental car charges (economy or mid-size class only), including fuel for rental vehicles;
(d) Meals During Travel: Reasonable meal expenses incurred by Speaker while traveling to and from the Speaker Program venue, subject to the per-person meal cap set forth in Section 6.2 below.
6.2 Meal and Hospitality Cap. Meals and refreshments provided in connection with any Speaker Program — whether provided to Speaker, to attendees, or to Company personnel — shall not exceed One Hundred Fifty Dollars ($150.00) per person per event, inclusive of tax, gratuity, and service charges, in alignment with the AdvaMed Code of Ethics on Interactions with U.S. Health Care Professionals (2020 Revision) and the Company's internal policies. This per-person cap applies individually to each person who receives a meal or refreshments in connection with the Speaker Program. Alcoholic beverages are strictly prohibited at all Company-sponsored Speaker Programs and may not be purchased, served, offered, or reimbursed under any circumstances, regardless of whether the cost would fall within the per-person cap.
6.3 Expense Documentation. Speaker must submit a completed Expense Reimbursement Form (Exhibit G) together with itemized receipts for all reimbursable expenses within fourteen (14) calendar days following the date of the applicable Speaker Program. Expenses submitted without adequate supporting documentation, without itemized receipts, in excess of applicable category limits or per-person caps, or after the fourteen (14) day submission deadline will not be reimbursed. The Company reserves the right to request additional documentation or clarification regarding any submitted expense. Reimbursement requests are subject to review and approval by the Compliance Officer or designee.
6.4 No Spouse/Guest Travel. The Company shall not reimburse, and Speaker shall not submit requests for reimbursement of, any travel, lodging, meal, or other expenses incurred by or on behalf of Speaker's spouse, domestic partner, family members, companions, or other guests, regardless of whether such individuals accompany Speaker to the Speaker Program venue. Any such expenses are the sole financial responsibility of Speaker.
ARTICLE 7 — VENUE REQUIREMENTS AND RESTRICTIONS
7.1 Approved Venues. Speaker Programs shall be held only at venues that are conducive to a professional, educational setting and that are selected based on their suitability for the educational objectives of the program rather than for entertainment, recreational, or social purposes. Approved venue types include, without limitation:
(a) Hospital or healthcare facility conference rooms, auditoriums, or meeting spaces;
(b) Medical office settings, including physician group practice conference rooms and ambulatory care facility meeting rooms;
(c) Hotels with dedicated meeting or conference room facilities (excluding resort properties as described in Section 7.2 below), where the meeting room is the primary purpose for venue selection;
(d) Restaurant private dining rooms, suitable for modest meal programs where the educational presentation is the primary purpose of the event and the meal is incidental and subordinate to the educational component.
7.2 Prohibited Venues. Speaker Programs shall not be held at any venue that falls within the following categories, and the Company will not approve any Needs-Assessment Form proposing such a venue:
(a) Entertainment or recreational venues, including without limitation sporting event venues (stadiums, arenas, racetracks), theaters, concert halls, amusement parks, theme parks, golf courses, country clubs, ski resorts, bowling alleys, or similar establishments;
(b) Resort hotels, resort-style properties, or destination resorts, including any property that markets itself primarily as a resort, spa, or vacation destination;
(c) Bars, nightclubs, lounges, breweries, wineries, distilleries, or similar establishments where the primary business activity is the service of alcoholic beverages;
(d) Any other venue selected primarily for its entertainment, recreational, scenic, or luxury characteristics rather than its suitability as an educational meeting space.
7.3 Venue Pre-Approval. All proposed venues must be identified and pre-approved as part of the needs-assessment process described in Article 3 of this Agreement. The venue name, address, venue type, and confirmation that the venue does not fall within any prohibited category must be documented on the Needs-Assessment Form (Exhibit D) and approved by the Compliance Officer or designee before the venue is reserved or any invitations are issued. If circumstances require a change of venue after initial approval, the revised venue must be separately pre-approved through the same process.
ARTICLE 8 — CONTENT RESTRICTIONS AND PROMOTIONAL COMPLIANCE
8.1 Approved Slide Deck Only. Speaker shall use only the current version of the Approved Slide Deck provided by the Company for each Speaker Program. Speaker acknowledges that the Approved Slide Deck has been prepared and reviewed by the Company's MLR Committee to ensure compliance with FDA regulations, the Cleared Indications, and the Company's promotional review standards. Speaker shall not modify, supplement, rearrange, annotate, add slides to, delete slides from, or otherwise deviate from the Approved Slide Deck in any manner without prior written authorization from the Company's MLR Committee. Any unauthorized modification of the Approved Slide Deck shall constitute a material breach of this Agreement.
8.2 On-Label Presentations Only. All presentations delivered by Speaker at Speaker Programs, including all oral remarks, visual presentations, responses to audience questions, and informal discussions with attendees before, during, and after the formal presentation, must be limited to the Cleared Indications of the Pulsar™ CRM System — specifically, continuous cardiac rhythm monitoring in adult patients with suspected or documented cardiac arrhythmias — as described in the FDA 510(k) clearance (No. K232847) and the FDA-cleared product labeling. Speaker shall not discuss, promote, endorse, suggest, or imply any Off-Label Use of the Pulsar™ CRM System, including without limitation use in pediatric patients, use for indications not described in the cleared labeling, or use in clinical scenarios outside the approved patient population.
8.3 Prohibition on Off-Label Discussion. Speaker acknowledges that attendees at Speaker Programs may ask questions that touch upon or require discussion of Off-Label Uses of the Pulsar™ CRM System. In the event that an attendee poses such a question, Speaker shall adhere to the following protocol:
(a) Speaker shall politely decline to address the off-label question during the Speaker Program, explaining that Speaker is not authorized to discuss uses outside the FDA-cleared indications in the context of a Company-sponsored program;
(b) Speaker shall direct the attendee to the Company's Medical Affairs department for any unsolicited medical information requests regarding off-label topics. The primary Medical Affairs contact for such inquiries is Dr. Nadia Farouk, Vice President, Medical Affairs, Solstice Biomedical Inc. The Program Coordinator will provide attendees with appropriate contact information upon request;
(c) Speaker shall document the off-label question on the Program Completion Form (Exhibit F), including a brief description of the question asked and confirmation that the question was redirected to Medical Affairs.
8.4 Fair Balance. All presentations delivered by Speaker must include a fair and balanced presentation of both the benefits and the risks associated with the Pulsar™ CRM System, consistent with the product labeling, the FDA-cleared indications, and applicable FDA requirements for the promotion of Class II medical devices. Speaker shall not overemphasize the benefits of the device while minimizing or omitting known risks, warnings, precautions, contraindications, or adverse events described in the product labeling. The Approved Slide Deck contains fair balance information that must be presented in its entirety during each Speaker Program.
8.5 No Comparative Claims. Speaker shall not make any unapproved comparative claims, either express or implied, regarding the Pulsar™ CRM System relative to competing products, including but not limited to the predicate device referenced in the Company's 510(k) submission (510(k) No. K201156) or any other subcutaneous implantable cardiac monitor or cardiac rhythm management device on the market. Comparative claims may only be presented if they are expressly included in the current version of the Approved Slide Deck, as reviewed and approved by the Company's MLR Committee, and are supported by adequate substantiation.
8.6 No Guarantees. Speaker shall not make any guarantees, warranties, promises, or assurances regarding the performance, efficacy, clinical outcomes, reliability, durability, or results of the Pulsar™ CRM System that go beyond what is stated in the Approved Slide Deck and the FDA-cleared product labeling. Speaker shall not represent or imply that the Pulsar™ CRM System will achieve any specific clinical result for any individual patient.
ARTICLE 9 — COMPLIANCE OBLIGATIONS
9.1 Anti-Kickback Statute Compliance. Speaker acknowledges that this Agreement is structured and intended to comply with the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)) and, in particular, with the personal services and management contracts safe harbor set forth at 42 C.F.R. § 1001.952(d). Speaker acknowledges that the Anti-Kickback Statute prohibits the knowing and willful solicitation, receipt, offer, or payment of any remuneration (including any kickback, bribe, or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward referrals for, or the ordering, purchasing, leasing, or arranging for the ordering, purchasing, or leasing of, any item or service reimbursable under any federal healthcare program. Speaker agrees that no part of the compensation paid under this Agreement is intended to, or does, induce or reward the referral of patients, the ordering or purchasing of any product (including the Pulsar™ CRM System or any other Solstice product), or the generation or arrangement of any business reimbursable under Medicare, Medicaid, TRICARE, or any other federal healthcare program.
9.2 False Claims Act. Speaker shall not, in connection with any Speaker Program or any other activity under this Agreement, make any false, misleading, inaccurate, or fraudulent statement, claim, or representation regarding the Pulsar™ CRM System, its cleared indications, its clinical performance, its coverage or reimbursement status under any federal or state healthcare program, its coding (including CPT, ICD-10, or HCPCS codes), or any other matter. Speaker acknowledges that false or misleading statements may give rise to liability under the federal False Claims Act (31 U.S.C. §§ 3729–3733) and analogous state false claims statutes, and that violations may result in significant civil and criminal penalties.
9.3 AdvaMed Code. The Parties agree that this Agreement and all activities conducted hereunder shall comply in all respects with the AdvaMed Code of Ethics on Interactions with U.S. Health Care Professionals (2020 Revision), including without limitation the provisions relating to consultant arrangements, compensation at fair market value, needs assessments, venue selection, meals and hospitality, and educational programs. In the event of any conflict between the provisions of this Agreement and the AdvaMed Code, the more restrictive provision shall control.
9.4 State Law Compliance. Speaker acknowledges that various states have enacted laws and regulations that impose additional requirements and restrictions on interactions between medical device companies and healthcare professionals, which may include, without limitation, gift bans or gift limitations, aggregate spend reporting and transparency requirements, marketing code of conduct adoption mandates, and registration or licensing requirements for pharmaceutical and medical device representatives. Speaker agrees to cooperate with the Company in identifying and complying with all state laws and regulations applicable to Speaker's activities under this Agreement, including by providing information necessary for the Company to comply with state transparency reporting obligations. Speaker shall promptly notify the Company if Speaker becomes aware of any state law or regulation that may affect Speaker's eligibility to participate in, or the Company's ability to conduct, Speaker Programs in any particular jurisdiction.
9.5 No Referral Obligation. Nothing in this Agreement shall be construed to require, obligate, or incentivize Speaker to order, recommend, prescribe, purchase, lease, use, or arrange for the ordering, recommending, prescribing, purchasing, leasing, or use of the Pulsar™ CRM System or any other Solstice product, either during the Term or at any time thereafter. Speaker's compensation under this Agreement is fixed, is based solely on the fair market value of the speaking services rendered, and is in no way conditioned upon, influenced by, or correlated with any volume or value of referrals, orders, purchases, or other business generated by Speaker for the Company or any affiliate of the Company.
9.6 Compliance Certifications. Speaker shall execute the Compliance Certification in the form attached hereto as Exhibit C concurrently with the execution of this Agreement. Thereafter, during the Term of this Agreement, Speaker shall execute a new Compliance Certification on an annual basis, on or before the anniversary of the Effective Date. The Company may also request that Speaker execute an updated Compliance Certification at any time upon reasonable notice if there has been a material change in applicable law, regulation, or Company policy. Failure to timely execute a required Compliance Certification shall constitute grounds for suspension of Speaker's engagement pending completion of the certification.
9.7 Government Exclusion. Speaker represents and warrants that, as of the Effective Date and at all times during the Term of this Agreement:
(a) Speaker is not excluded, debarred, or suspended from participation in any federal healthcare program, including Medicare, Medicaid, and TRICARE;
(b) Speaker is not listed on the U.S. Department of Health and Human Services, Office of Inspector General ("OIG") List of Excluded Individuals/Entities ("LEIE"), the U.S. General Services Administration System for Award Management ("SAM") Exclusions database, or any equivalent state exclusion list;
(c) Speaker is not subject to any pending investigation, proceeding, or action by any federal, state, or local governmental authority that could reasonably be expected to result in Speaker's exclusion, debarment, or suspension from any federal healthcare program.
Speaker agrees to notify the Company immediately, and in no event later than five (5) business days, upon learning of any event, investigation, proceeding, or action that could result in Speaker's exclusion, debarment, or suspension from any federal healthcare program. The Company reserves the right to verify Speaker's exclusion status at any time during the Term by searching the OIG LEIE, the SAM Exclusions database, and applicable state exclusion databases, and Speaker consents to such verification.
9.8 Compliance Hotline. The Company maintains an anonymous compliance reporting hotline operated by Clearpath Ethics Services Inc., an independent third-party compliance services provider. Speaker, Company employees, and any other individual may report concerns regarding potential violations of law, regulation, Company policy, or the terms of this Agreement, including concerns related to the Anti-Kickback Statute, the False Claims Act, off-label promotion, or any other compliance matter. Reports may be made anonymously and without fear of retaliation by calling the hotline at [Insert Hotline Number] or by accessing the secure web reporting portal at [Insert URL]. The Company prohibits retaliation against any individual who makes a good-faith report of a compliance concern.
ARTICLE 10 — TERM AND TERMINATION
10.1 Term. This Agreement shall be effective as of the Effective Date and shall continue for a period of [Insert — e.g., one (1) year] from the Effective Date, unless earlier terminated in accordance with the provisions of this Article 10 (the "Term"). Upon expiration of the initial Term, this Agreement may be renewed for additional successive periods of [Insert — e.g., one (1) year] each upon the mutual written agreement of both Parties. Any renewal shall be documented in a written amendment or renewal notice signed by both Parties at least thirty (30) days prior to the expiration of the then-current Term. Each renewal period shall be subject to a renewed needs assessment and fair market value confirmation in accordance with Company policy.
10.2 Termination for Convenience. Either Party may terminate this Agreement at any time, with or without cause, upon [Insert — e.g., thirty (30)] days' prior written notice to the other Party. Written notice of termination for convenience shall be delivered in accordance with Section 16.7 of this Agreement.
10.3 Termination for Cause. The Company may terminate this Agreement immediately upon written notice to Speaker, without any requirement for a cure period, if any of the following events occurs:
(a) Speaker breaches any provision of Article 8 (Content Restrictions and Promotional Compliance) or Article 9 (Compliance Obligations), including but not limited to any modification of the Approved Slide Deck, promotion of Off-Label Use, or failure to comply with the Anti-Kickback Statute or the AdvaMed Code;
(b) Speaker is excluded, debarred, or suspended from participation in any federal or state healthcare program, or is listed on the OIG LEIE, the SAM Exclusions database, or any equivalent state exclusion list;
(c) Speaker loses, or has suspended, revoked, restricted, or surrendered, any medical license, DEA registration, or other professional license or certification required for Speaker's practice of medicine or delivery of Speaker Programs;
(d) Speaker engages in conduct that, in the Company's sole and reasonable judgment, creates a material compliance risk, legal risk, or reputational risk to the Company, including but not limited to conduct involving fraud, dishonesty, moral turpitude, substance abuse, patient safety concerns, or public statements inconsistent with the Company's values or compliance program;
(e) Speaker fails to complete or pass Speaker Training, any required refresher training, or any required Compliance Certification within the time frames established by the Company;
(f) Speaker violates any applicable federal, state, or local law, regulation, or professional ethical standard in connection with Speaker's performance under this Agreement.
10.4 Effect of Termination. Upon the effective date of termination or expiration of this Agreement, regardless of the reason:
(a) Speaker shall immediately cease all activities under this Agreement, including the delivery of any scheduled but not yet completed Speaker Programs;
(b) The Company shall pay Speaker for any Speaker Programs that were completed prior to the effective date of termination and for which payment has not yet been made, subject to submission of a completed Program Completion Form (Exhibit F) and compliance with the payment terms set forth in Section 5.4. For the avoidance of doubt, no honorarium shall be payable for any Speaker Program scheduled but not delivered as of the effective date of termination;
(c) Speaker shall promptly return to the Company all Approved Slide Decks (in both physical and electronic form), Company-provided materials, training materials, attendee lists, and any other confidential information or Company property in Speaker's possession or control. Speaker shall permanently delete all electronic copies of such materials from Speaker's computers, devices, and cloud storage accounts and shall certify such deletion in writing upon request by the Company.
10.5 Survival. The following provisions of this Agreement shall survive the expiration or termination of this Agreement for any reason and shall continue in full force and effect thereafter: Article 9 (Compliance Obligations), Article 11 (Physician Payments Sunshine Act / Open Payments Reporting), Article 12 (Confidentiality), Article 13 (Representations and Warranties), Article 14 (Intellectual Property), Article 15 (Indemnification), and Sections 16.1 (Governing Law), 16.5 (Severability), and 16.7 (Notices). The survival of these provisions is necessary to give effect to the Parties' intent with respect to the ongoing obligations described therein and shall not be limited by any statute of limitations applicable to claims arising under this Agreement.
ARTICLE 11 — PHYSICIAN PAYMENTS SUNSHINE ACT / OPEN PAYMENTS REPORTING
11.1 Reporting Obligation. Speaker acknowledges that the Company is an "applicable manufacturer" as defined under the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h) and the implementing regulations promulgated by CMS at 42 C.F.R. Part 403, Subpart I. As an applicable manufacturer, the Company is required by federal law to collect, track, and report to CMS, through the Open Payments system, all payments and other transfers of value made directly or indirectly to Covered Recipients, including physicians such as Speaker.
11.2 Reportable Payments. Speaker acknowledges and expressly consents that the Company will report to CMS all payments and transfers of value made to Speaker under this Agreement, including without limitation honoraria for Speaker Programs, reimbursement of travel expenses (airfare, hotel, ground transportation), meals and refreshments provided in connection with Speaker Programs, and any other items or services of value provided to Speaker, to the extent such payments or transfers of value meet or exceed the applicable CMS reporting thresholds, which are currently set at $12.49 per individual payment or transfer of value, or $100.00 in aggregate per Covered Recipient per calendar year (as indexed for calendar year 2024). Speaker understands that these thresholds are subject to annual adjustment by CMS.
11.3 Data Accuracy. Speaker agrees to provide the Company, upon execution of this Agreement and promptly thereafter upon any change, with accurate, current, and complete information necessary for the Company to fulfill its Open Payments reporting obligations, including without limitation Speaker's full legal name, National Provider Identifier (NPI) number, primary medical specialty, primary practice address (street address, city, state, and ZIP code), and state medical license number(s). Speaker shall promptly notify the Company in writing of any changes to such information during the Term of this Agreement.
11.4 Review Period. Speaker understands that CMS provides an annual review and dispute period during which Covered Recipients may review, and if appropriate, dispute, the accuracy of payment data reported by applicable manufacturers before such data is made publicly available on the CMS Open Payments website. The Company will use commercially reasonable efforts to notify Speaker of the applicable review period and to cooperate with Speaker in resolving any data discrepancies identified by Speaker during the review period.
11.5 Reporting Deadline. For calendar year 2024 transfers of value, the Company is required to submit its Open Payments report to CMS by March 31, 2025. The Company's CMS Manufacturer Identification application for the Open Payments system was submitted in June 2024. Speaker acknowledges that the Company's reporting obligations are ongoing and that data for subsequent calendar years will be reported in accordance with the then-applicable CMS deadlines.
11.6 Consent. By executing this Agreement, Speaker expressly and irrevocably consents to the Company's collection, storage, processing, use, and disclosure of Speaker's personal information (including name, NPI number, specialty, practice address, and state license number) and payment information (including the nature, amount, and date of each payment or transfer of value) as necessary to comply with the Company's Open Payments reporting obligations under the Physician Payments Sunshine Act and implementing regulations. Speaker further acknowledges that reported data will be made publicly available on the CMS Open Payments website and that the Company has no control over the public availability of such data once it has been accepted by CMS.
ARTICLE 12 — CONFIDENTIALITY
12.1 Confidential Information. Speaker agrees to maintain in strict confidence all non-public, proprietary, or confidential information disclosed by the Company to Speaker in connection with this Agreement or Speaker's engagement hereunder (collectively, "Confidential Information"). Confidential Information includes, without limitation, the Company's business strategies, marketing plans, pricing information, customer and distributor information, product pipeline and development information, clinical data and study results not yet published, regulatory submissions, manufacturing processes, financial information and projections, sales data, employee information, trade secrets, and any proprietary content contained in the Approved Slide Deck, training materials, or other Company-provided materials. Speaker shall not disclose, publish, disseminate, or otherwise communicate any Confidential Information to any third party without the prior written consent of the Company, and shall not use any Confidential Information for any purpose other than the performance of Speaker's obligations under this Agreement.
12.2 Exceptions. The confidentiality obligations set forth in Section 12.1 shall not apply to information that:
(a) is or becomes generally available to the public through no act, omission, or fault of Speaker;
(b) was in Speaker's possession prior to disclosure by the Company, as demonstrated by Speaker's written records;
(c) is independently developed by Speaker without reference to, reliance upon, or use of any Confidential Information of the Company, as demonstrated by Speaker's written records; or
(d) is required to be disclosed by applicable law, regulation, court order, subpoena, or other legal process, provided that Speaker shall, to the extent legally permitted, provide the Company with prompt written notice of such required disclosure so that the Company may seek an appropriate protective order or other remedy, and Speaker shall disclose only that portion of the Confidential Information that is legally required to be disclosed.
12.3 Return of Materials. Upon termination or expiration of this Agreement, or at any time upon the Company's written request, Speaker shall promptly return to the Company all documents, materials, files, and media (in both physical and electronic form) containing or embodying Confidential Information, or, at the Company's direction, permanently destroy such materials and certify such destruction in writing to the Company. The obligations set forth in this Article 12 shall survive the expiration or termination of this Agreement for a period of five (5) years.
ARTICLE 13 — REPRESENTATIONS AND WARRANTIES
13.1 Speaker Representations and Warranties. Speaker represents and warrants to the Company, as of the Effective Date and at all times during the Term of this Agreement, as follows:
(a) Speaker holds a current, valid, and unrestricted license to practice medicine in the State(s) of [Insert State(s)] and is in good standing with the applicable state medical board(s);
(b) Speaker possesses the qualifications, training, clinical expertise, and professional experience necessary to deliver Speaker Programs on the Pulsar™ CRM System, including expertise in the field of [Insert Specialty — e.g., electrophysiology, cardiology];
(c) Speaker is not a party to, and Speaker's performance under this Agreement will not violate or conflict with, any other agreement, arrangement, obligation, or understanding (whether written or oral) to which Speaker is a party or by which Speaker is bound;
(d) Speaker is not excluded, debarred, or suspended from participation in any federal or state healthcare program, and is not listed on the OIG LEIE, the SAM Exclusions database, or any equivalent state exclusion list, as more fully described in Section 9.7;
(e) Speaker will disclose to the Company, promptly upon execution of this Agreement and on an ongoing basis during the Term, all financial relationships (including consulting agreements, advisory board memberships, research grants, equity interests, and speaker engagements) that Speaker maintains with competitors of the Company in the cardiac rhythm management device space, including without limitation manufacturers of implantable cardiac monitors, pacemakers, implantable cardioverter-defibrillators, and cardiac resynchronization therapy devices;
(f) All information provided by Speaker to the Company in connection with this Agreement, including information provided for credentialing, needs-ass

SPEAKER PROGRAM AGREEMENT

INTRODUCTORY INSTRUCTIONS / USAGE NOTES

SPEAKER PROGRAM AGREEMENT

Record

Parties

Dates

Amounts