PHYSICIAN CONSULTING AGREEMENT
Template — For Use by Solstice Biomedical Inc.
Prepared by:
Calderwood & Harkness LLP 1250 Avenue of the Americas, 38th Floor New York, NY 10020
Matter No.: 1037-00003
Version: Final Template — August 2024
CONFIDENTIAL — This document is confidential and proprietary to Solstice Biomedical Inc. and is protected by the attorney-client privilege and the work product doctrine. Unauthorized reproduction, distribution, or disclosure of this document or any portion thereof is strictly prohibited.
INTERNAL GUIDANCE NOTE — DO NOT INCLUDE IN EXECUTED COPIES
This template Physician Consulting Agreement has been designed to qualify under the Anti-Kickback Statute personal services and management contracts safe harbor set forth at 42 C.F.R. § 1001.952(d). All elements of the safe harbor have been incorporated into the template, including requirements that: (i) the agreement is set out in writing and signed by the parties; (ii) the agreement specifies the services to be provided; (iii) the term of the agreement is for not less than one year; (iv) if services are provided on a periodic, sporadic, or part-time basis, the agreement specifies exactly the schedule of such intervals, their precise length, and the exact charge for such intervals; (v) the aggregate compensation paid over the term is set in advance, is consistent with fair market value in arm's-length transactions, and is not determined in a manner that takes into account the volume or value of any referrals or business otherwise generated between the parties; and (vi) the services do not involve the counseling or promotion of a business arrangement or other activity that violates any state or federal law.
This template must not be modified without prior written approval of the Solstice Biomedical Inc. Legal Department or Calderwood & Harkness LLP as outside counsel. All bracketed fields must be completed prior to execution. If any substantive changes to the template are proposed, contact the Legal Department at legal@solsticebiomedical.com or Calderwood & Harkness LLP, Attention: Healthcare & Life Sciences Practice Group.
PHYSICIAN CONSULTING AGREEMENT
This Physician Consulting Agreement (this "Agreement") is entered into as of \\\\\\\\\\\\\\\\\\\\\\\\ (the "Effective Date"),
BY AND BETWEEN:
Solstice Biomedical Inc., a Delaware corporation, with principal offices at 200 Harborview Drive, Suite 1100, Boston, MA 02210 (EIN: 93-4718206) (the "Company"),
— and —
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_, M.D./D.O., an individual with a principal practice address at \\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\_ (the "Consultant").
The Company and the Consultant are each referred to herein individually as a "Party" and collectively as the "Parties."
RECITALS
WHEREAS, the Company is engaged in the development, manufacture, and commercialization of medical devices, including the Pulsar™ CRM System, an FDA-cleared (510(k) No. K232847) Class II subcutaneous implantable cardiac monitor with cloud-based remote telemetry platform, indicated for continuous cardiac rhythm monitoring in adult patients with suspected or documented cardiac arrhythmias;
WHEREAS, the Company desires to engage physician consultants who possess specialized knowledge and expertise in \\\\\\\\\\\\\\\\\\\\\\\\\\\\\\ (Insert relevant specialty area, e.g., cardiac electrophysiology, cardiology, cardiac rhythm management) to provide bona fide consulting services in connection with \\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\_ (Insert general description of legitimate business need);
WHEREAS, the Company has conducted a legitimate business needs assessment and has determined that the Consultant possesses qualifications, expertise, and experience that are necessary to fulfill the scope of services described herein, and that such determination was made independently of any existing or potential referral relationship between the Parties;
WHEREAS, the Consultant desires to provide such consulting services to the Company on the terms and conditions set forth in this Agreement;
WHEREAS, the Parties intend that this Agreement and the compensation paid hereunder shall comply with all applicable federal and state laws and regulations, including the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), and shall satisfy the requirements of the personal services and management contracts safe harbor (42 C.F.R. § 1001.952(d));
WHEREAS, the Parties acknowledge that the Consultant's compensation hereunder has been determined to reflect fair market value for the services rendered and is not determined in a manner that takes into account the volume or value of any referrals or business otherwise generated between the Parties; and
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:
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ARTICLE 1 — DEFINITIONS
As used in this Agreement, the following terms shall have the meanings set forth below. Capitalized terms used in this Agreement that are not defined in this Article 1 shall have the meanings ascribed to them elsewhere in this Agreement and the Exhibits hereto.
1.1 "Affiliate" means any entity that directly or indirectly controls, is controlled by, or is under common control with the Company, where "control" means the direct or indirect ownership of more than fifty percent (50%) of the outstanding voting securities of such entity or the power to direct the management and policies of such entity, whether through ownership of voting securities, by contract, or otherwise. Without limiting the generality of the foregoing, "Affiliate" includes Solstice Biomedical Devices Ltd., an Irish private limited company and the Company's parent corporation, and any direct or indirect subsidiary of Solstice Biomedical Devices Ltd.
1.2 "Anti-Kickback Statute" or "AKS" means 42 U.S.C. § 1320a-7b(b), as amended from time to time, together with all regulations promulgated thereunder and all authoritative guidance issued by the OIG or other governmental authority with respect thereto.
1.3 "AdvaMed Code" means the Code of Ethics on Interactions with Healthcare Professionals, as published by the Advanced Medical Technology Association (AdvaMed), 2020 Revision, including any supplements, appendices, or interpretive guidance issued in connection therewith.
1.4 "Applicable Law" means all federal, state, and local laws, statutes, rules, regulations, ordinances, orders, and directives applicable to the subject matter of this Agreement, including without limitation: (a) the AKS; (b) the False Claims Act (31 U.S.C. §§ 3729–3733); (c) the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h) and the regulations promulgated thereunder; (d) the federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301 et seq.) and all applicable FDA regulations; (e) the Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a); (f) the Stark Law (42 U.S.C. § 1395nn), to the extent applicable; (g) the Health Insurance Portability and Accountability Act (HIPAA) (42 U.S.C. § 1320d et seq.) and the regulations promulgated thereunder; and (h) applicable state marketing compliance laws, gift ban statutes, aggregate spend reporting requirements, and pharmaceutical and medical device industry interaction laws.
1.5 "Compensation Schedule" means the schedule of hourly rates, annual compensation cap, expense reimbursement terms, and payment terms as set forth in Exhibit B attached hereto and incorporated herein by reference.
1.6 "Compliance Certification" means the certification in the form attached hereto as Exhibit C, which the Consultant shall execute and deliver on or before the Effective Date and annually thereafter during the Term.
1.7 "Covered Recipient" means a "covered recipient" as defined by the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h) and the CMS Open Payments regulations (42 C.F.R. Part 403, Subpart I), including physicians and teaching hospitals, as such terms are further defined in such statute and regulations.
1.8 "Fair Market Value" or "FMV" means the value in arm's-length transactions, consistent with the general market value of the services provided, without adjustment or consideration for the volume or value of any referrals or business otherwise generated between the Parties, as determined by independent valuation methodologies including, without limitation, third-party benchmarking surveys, physician compensation surveys, and comparable transaction analyses.
1.9 "FDA" means the United States Food and Drug Administration, or any successor agency thereof.
1.10 "Federal Health Care Program" has the meaning set forth in 42 U.S.C. § 1320a-7b(f), and includes, without limitation, Medicare, Medicaid, TRICARE, the Veterans Health Administration, the Federal Employees Health Benefits Program, and any other plan or program that provides health benefits, whether directly, through insurance, or otherwise, that is funded directly, in whole or in part, by the United States Government or any state health care program.
1.11 "OIG" means the Office of Inspector General of the United States Department of Health and Human Services.
1.12 "Open Payments" means the CMS transparency reporting program established under the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h) and implemented through 42 C.F.R. Part 403, Subpart I, pursuant to which applicable manufacturers and applicable group purchasing organizations are required to report certain transfers of value to covered recipients.
1.13 "Scope of Services" means the consulting services described in Exhibit A attached hereto and incorporated herein by reference, including the description of services, deliverables, schedule, estimated hours, and location of services.
1.14 "Term" has the meaning set forth in Section 3.1.
ARTICLE 2 — ENGAGEMENT; SCOPE OF SERVICES
2.1 Engagement. The Company hereby engages the Consultant, and the Consultant hereby accepts such engagement, to provide the consulting services described in the Scope of Services (Exhibit A), subject to and in accordance with the terms and conditions of this Agreement. The engagement of the Consultant hereunder is based upon the Company's determination that the Consultant possesses the qualifications, expertise, and experience necessary to fulfill the Scope of Services, and that the engagement serves a legitimate, documented business need of the Company.
2.2 Scope of Services. The Consultant shall perform the services described in Exhibit A attached hereto and incorporated herein by reference. Exhibit A shall describe with specificity:
(a) the nature of the services to be rendered by the Consultant;
(b) the specific deliverables expected from the Consultant;
(c) the estimated number of hours required for the performance of such services; and
(d) the timeline for performance, including start and end dates for each task or deliverable.
The Consultant shall not perform any services beyond those described in Exhibit A without the prior written approval of the Company. Any material changes to the Scope of Services shall require a written amendment to Exhibit A, executed by both Parties and approved by the Company's Legal Department and/or Compliance Department.
2.3 Legitimate Business Need. The Company represents that it has documented the legitimate business need for the services to be provided by the Consultant, independent of any referral or purchasing relationship between the Parties or any other consideration relating to the volume or value of business generated between the Parties. Such documentation has been prepared in accordance with the Company's internal Legitimate Business Need Assessment process and shall be maintained in the Company's compliance files for a period of not less than ten (10) years following the termination or expiration of this Agreement. The Company further represents that the Consultant was selected based on the Consultant's qualifications, expertise, and experience, and not based on the Consultant's prescribing, purchasing, ordering, or referral patterns with respect to the Company's products.
2.4 Independent Contractor Status. The Consultant is an independent contractor and not an employee, agent, joint venturer, partner, or representative of the Company. Nothing in this Agreement shall be construed to create a partnership, joint venture, agency, or employment relationship between the Parties. The Consultant shall have no authority to bind the Company or to make any representation or commitment on behalf of the Company. The Consultant shall be solely responsible for the payment of all federal, state, and local taxes, including self-employment taxes, arising from compensation received under this Agreement. The Company shall not withhold any federal, state, or local income tax, social security tax, or any other payroll tax from the Consultant's compensation, and the Company shall not provide the Consultant with any employee benefits, including but not limited to health insurance, retirement benefits, workers' compensation, or disability insurance.
2.5 Non-Exclusivity. This Agreement does not create an exclusive relationship between the Parties. The Consultant may engage in other professional and consulting activities, provided that such activities do not: (a) conflict with the Consultant's obligations under this Agreement; (b) involve the disclosure of the Company's Confidential Information; or (c) create an actual or apparent conflict of interest with respect to the Consultant's obligations hereunder. The Company may engage other consultants to perform similar or identical services during the Term of this Agreement.
ARTICLE 3 — TERM AND TERMINATION
3.1 Term. This Agreement shall commence on the Effective Date and shall continue for a period of \\\\\\\\\\\\\\\\\\\\\\ (Insert: twelve (12) months / other specified period) (the "Initial Term"), unless earlier terminated in accordance with this Article 3. The Initial Term and any renewal term are collectively referred to as the "Term." The term and schedule of services, including the number of hours, intervals, and precise schedule of engagement, shall be set forth in advance in Exhibit A, consistent with the requirement of the AKS personal services and management contracts safe harbor (42 C.F.R. § 1001.952(d)) that the aggregate services, their schedule, and the compensation therefor be specified in advance in a written agreement.
3.2 Renewal. This Agreement may be renewed for successive \\\\\\\\\\\\\\\\\\\\ (Insert: twelve (12)-month) periods (each, a "Renewal Term") upon the mutual written agreement of the Parties, executed at least thirty (30) days prior to the expiration of the then-current Term. As a condition to any renewal, the Company shall conduct a renewed legitimate business need assessment and an updated FMV determination prior to the commencement of each Renewal Term. The results of such renewed assessment and FMV determination shall be documented and maintained in the Company's compliance files. In the event the Parties agree to a Renewal Term, the Parties shall execute a renewed or updated Exhibit A and Exhibit B reflecting the Scope of Services and Compensation Schedule applicable to the Renewal Term, and the Consultant shall execute an updated Compliance Certification (Exhibit C).
3.3 Termination for Convenience. Either Party may terminate this Agreement without cause upon thirty (30) days' prior written notice to the other Party, delivered in accordance with Section 10.8. In the event of termination for convenience, the Company shall pay the Consultant for all services satisfactorily performed through the effective date of termination, in accordance with the Compensation Schedule (Exhibit B), and neither Party shall have any further obligation to the other except as set forth in Section 3.6.
3.4 Termination for Cause. Either Party may terminate this Agreement immediately upon written notice to the other Party if the other Party:
(a) materially breaches any provision of this Agreement and fails to cure such breach within fifteen (15) days after receipt of written notice specifying the nature of the breach with reasonable particularity;
(b) breaches any representation or warranty set forth in Article 8 (Compliance Representations and Warranties), which breach shall not be subject to cure;
(c) is excluded, debarred, or suspended from participation in any Federal Health Care Program, or is placed on the OIG List of Excluded Individuals/Entities (LEIE) or the GSA System for Award Management (SAM) Excluded Parties List;
(d) is convicted of, or enters a plea of guilty or nolo contendere to, a criminal offense related to healthcare fraud, patient abuse or neglect, a controlled substance, or any felony offense; or
(e) violates any Applicable Law in connection with the performance of services under this Agreement.
3.5 Termination for Compliance Violations. Without limiting the rights of the Company under Section 3.4, the Company shall have the right to terminate this Agreement immediately upon written notice to the Consultant if the Company determines, in its reasonable discretion, that:
(a) the Consultant has violated any provision of the Company's Code of Conduct, the Company's compliance policies and procedures, or the AdvaMed Code;
(b) continuation of this Agreement may create a material risk of violation of the AKS, the False Claims Act, or any other Applicable Law, whether or not the Consultant has committed an actual violation; or
(c) the Consultant has failed to complete, execute, or update the Compliance Certification (Exhibit C) as required by Section 8.7 of this Agreement.
3.6 Effect of Termination. Upon the termination or expiration of this Agreement for any reason:
(a) the Consultant shall immediately cease all services under this Agreement and shall promptly return to the Company, or at the Company's election destroy, all of the Company's Confidential Information, property, materials, documents, and work product in the Consultant's possession or control, and shall certify such return or destruction in writing;
(b) the Company shall pay the Consultant for all services satisfactorily performed through the effective date of termination, in accordance with the terms of the Compensation Schedule (Exhibit B), provided that the Consultant submits a final invoice within thirty (30) days of the effective date of termination; and
(c) the provisions of Article 6 (Confidentiality), Article 7 (Intellectual Property), Article 8 (Compliance Representations and Warranties), Article 9 (Indemnification), and Article 10 (General Provisions) shall survive the termination or expiration of this Agreement and shall continue in full force and effect in accordance with their respective terms.
ARTICLE 4 — COMPENSATION
4.1 Hourly Rate. In consideration of the Consultant's performance of the services described in the Scope of Services (Exhibit A), the Company shall pay the Consultant at the hourly rate set forth in the Compensation Schedule (Exhibit B). The hourly rate is tiered based on the Consultant's medical specialty, years of relevant experience, and academic rank, within the range of Three Hundred Fifty Dollars ($350.00) to Five Hundred Dollars ($500.00) per hour, as specified in Exhibit B. The applicable hourly rate for this engagement is: $\\\\\\\\\\ per hour (Tier \\\\), as documented in Exhibit B. The hourly rate has been determined to reflect Fair Market Value based on independent benchmarking analysis conducted by or on behalf of the Company, the results of which are documented in the Company's compliance files.
4.2 Annual Cap. Notwithstanding any other provision of this Agreement to the contrary, total compensation paid to the Consultant under this Agreement shall not exceed Twelve Thousand Dollars ($12,000.00) in any twelve (12)-month period commencing on the Effective Date (the "Annual Cap"). The Company shall track cumulative payments made to the Consultant and shall not authorize or request services that would cause total compensation to exceed the Annual Cap without the execution of a written amendment to this Agreement, which amendment must be approved by the Company's Legal Department and/or Compliance Department. For purposes of this Section 4.2, "total compensation" includes all hourly fees paid to the Consultant but does not include reimbursement of pre-approved out-of-pocket expenses pursuant to Section 4.5, provided that such expenses are reimbursed at cost and do not include any mark-up, service fee, or similar charge.
4.3 Aggregate Compensation Set in Advance. The aggregate compensation to be paid to the Consultant over the Term, the Term of the Agreement, and the schedule of services to be performed hereunder are set forth in advance in this Agreement and the Exhibits hereto. This provision is intended to satisfy the requirement of the AKS personal services and management contracts safe harbor (42 C.F.R. § 1001.952(d)) that the aggregate compensation paid over the term of the agreement is set in advance, is consistent with fair market value in arm's-length transactions, and is not determined in a manner that takes into account the volume or value of any referrals or business otherwise generated between the parties for which payment may be made in whole or in part under a Federal Health Care Program.
4.4 Invoicing and Payment. The Consultant shall submit monthly invoices to the Company within fifteen (15) days following the end of each calendar month in which services are performed. Each invoice shall be submitted in a form acceptable to the Company and shall include the following information:
(a) a detailed description of the services performed during the applicable period, referenced to the specific tasks and deliverables described in Exhibit A;
(b) the date(s) on which services were performed;
(c) the number of hours spent on each task, in increments of no less than one-quarter (0.25) hour; and
(d) the applicable hourly rate, as set forth in Exhibit B.
The Company shall pay all undisputed invoices within thirty (30) days of receipt. If the Company disputes any portion of an invoice, the Company shall pay the undisputed portion within the thirty (30)-day period and shall notify the Consultant in writing of the disputed amount and the basis for the dispute within fifteen (15) days of receipt of the invoice. The Parties shall work in good faith to resolve any invoice disputes promptly.
4.5 Expenses. The Company shall reimburse the Consultant for reasonable, pre-approved, documented out-of-pocket expenses incurred in connection with the performance of services under this Agreement, including travel, lodging, and meals. All expense reimbursement shall comply with the following requirements:
(a) All expenses must be pre-approved in writing by the Company contact identified in Exhibit A prior to being incurred, unless otherwise specified in the Company's Travel and Expense Policy.
(b) All expense reimbursement shall comply with the Company's Travel and Expense Policy, a copy of which will be provided to the Consultant upon request, and with the AdvaMed Code, including without limitation the per-person meal and hospitality cap of One Hundred Fifty Dollars ($150.00) per attendee per event.
(c) Air travel shall be economy class for domestic flights under four (4) hours in duration. For domestic flights of four (4) hours or more, coach or premium economy class is permitted. Business class travel requires advance written approval from the Company.
(d) All expenses must be supported by itemized receipts and such other documentation as the Company may reasonably require.
(e) The Consultant shall submit expense reimbursement requests together with the monthly invoice described in Section 4.4, or separately within thirty (30) days of incurring the expense, whichever is earlier.
4.6 No Other Compensation. The Consultant shall not receive any other compensation, benefit, gift, gratuity, honorarium, entertainment, or item of value from the Company, its Affiliates, or its authorized distributors, dealers, or agents in connection with this engagement, except as expressly set forth in this Article 4. The Consultant acknowledges that the compensation and reimbursement provided under this Article 4 represents the totality of the consideration to be received by the Consultant in connection with services performed under this Agreement.
4.7 Taxes. The Consultant acknowledges and agrees that the Consultant is solely responsible for the payment of all federal, state, and local taxes, including income taxes, self-employment taxes, and any other applicable taxes, on compensation received under this Agreement. The Company shall not withhold or pay on the Consultant's behalf any income tax, social security tax, or any other payroll tax. The Company will issue IRS Form 1099-NEC to the Consultant for all compensation paid under this Agreement in accordance with applicable Internal Revenue Service requirements and tax reporting regulations.
4.8 No Volume- or Value-Based Compensation. Compensation under this Agreement is not, and shall not at any time be construed to be, determined in a manner that takes into account the volume or value of any referrals or business otherwise generated between the Parties or involving any Federal Health Care Program. The hourly rate and Annual Cap established in this Agreement and in Exhibit B reflect Fair Market Value for the bona fide consulting services to be performed by the Consultant and are not intended to compensate, reward, or induce any referral, purchase, order, prescription, or recommendation of any product or service of the Company or any Affiliate.
ARTICLE 5 — OBLIGATIONS OF THE CONSULTANT
5.1 Performance Standard. The Consultant shall perform all services under this Agreement in a professional, competent, diligent, and timely manner, consistent with the highest applicable standards of medical practice and professional ethics, and in accordance with the Scope of Services (Exhibit A). The Consultant represents that the Consultant possesses the knowledge, skills, qualifications, and experience necessary to perform the services described herein.
5.2 Time Commitment. The Consultant shall devote sufficient time and attention to the performance of services as specified in Exhibit A. The Consultant shall maintain accurate, contemporaneous time records documenting all hours worked under this Agreement, including the date, duration, and description of services performed. Such time records shall be made available to the Company upon request and shall be submitted with each monthly invoice in accordance with Section 4.4. The Company reserves the right to verify all time records in connection with its compliance monitoring obligations.
5.3 Deliverables. The Consultant shall provide all deliverables specified in Exhibit A in the format and by the deadlines specified therein. The Company shall have the right to review and approve all deliverables and to request reasonable revisions. The Consultant shall make all reasonable revisions requested by the Company without additional compensation, provided that such revisions do not materially change the scope of the original deliverable.
5.4 On-Label Communications. In performing services under this Agreement, the Consultant shall limit all discussions, opinions, presentations, writings, and communications regarding the Company's products, including without limitation the Pulsar™ CRM System, to the FDA-cleared indications for use and the labeling and promotional materials approved by the Company's Regulatory Affairs and Medical Affairs departments. The Consultant shall not promote, recommend, suggest, or encourage any off-label use of the Company's products. In the event the Consultant is asked about or becomes aware of off-label use discussions, the Consultant shall refrain from providing any guidance or endorsement and shall promptly notify the Company contact identified in Exhibit A.
5.5 Compliance Training. The Consultant shall complete the Company's compliance training program, as provided by the Company, prior to the commencement of services under this Agreement and annually thereafter during the Term. The compliance training program shall cover, at a minimum, the Anti-Kickback Statute, the False Claims Act, the Physician Payments Sunshine Act, the AdvaMed Code, on-label communications requirements, and the Company's Code of Conduct. The Company shall provide the Consultant with access to the compliance training materials and shall maintain records of the Consultant's completion of such training.
5.6 Disclosure of Conflicts. The Consultant shall promptly disclose to the Company, in writing, any actual or potential conflicts of interest that arise during the Term of this Agreement, including without limitation:
(a) financial relationships, including equity interests, consulting agreements, advisory board memberships, or speaker engagements, with competitors of the Company;
(b) advisory, consulting, or other contractual arrangements with other medical device or pharmaceutical companies that may create a conflict of interest with respect to the Consultant's obligations under this Agreement;
(c) any governmental investigation, proceeding, inquiry, audit, or enforcement action involving the Consultant that relates to healthcare fraud, abuse, compliance, or professional misconduct; and
(d) any relationship, financial interest, or other circumstance that could reasonably be expected to influence the Consultant's judgment, objectivity, or independence in performing services under this Agreement.
The Company shall review all conflict disclosures and shall determine, in its sole discretion, whether any disclosed conflict is material and, if so, what measures are necessary to mitigate or resolve such conflict, including potential termination of this Agreement.
ARTICLE 6 — CONFIDENTIALITY
6.1 Confidential Information. As used in this Agreement, "Confidential Information" means all non-public, proprietary, or confidential information of the Company or its Affiliates, whether disclosed in writing, orally, electronically, visually, or by any other means, and whether or not marked or identified as "confidential," that is disclosed to, or learned, observed, or obtained by, the Consultant in connection with the performance of services under this Agreement. Confidential Information includes, without limitation: (a) product development plans, research data, clinical trial data, and regulatory submissions; (b) marketing strategies, promotional materials, and commercial plans; (c) pricing information, financial data, projections, and business plans; (d) trade secrets, know-how, inventions, algorithms, software, and technical specifications; (e) customer and supplier lists, distribution agreements, and sales data; (f) personnel information and organizational plans; and (g) any other information that a reasonable person would understand to be confidential given the nature of the information and the circumstances of disclosure.
6.2 Non-Disclosure. The Consultant shall hold all Confidential Information in strict confidence and shall not disclose, publish, disseminate, or otherwise make available any Confidential Information to any third party without the prior written consent of the Company. The Consultant shall use Confidential Information solely for the purpose of performing services under this Agreement and shall not use Confidential Information for any other purpose, including without limitation for the Consultant's own benefit or for the benefit of any third party. The Consultant shall protect Confidential Information with at least the same degree of care that the Consultant uses to protect the Consultant's own confidential information, but in no event less than a reasonable degree of care.
6.3 Exceptions. The obligations set forth in Section 6.2 shall not apply to information that the Consultant can demonstrate by clear and convincing evidence: (a) was publicly available at the time of disclosure or thereafter becomes publicly available through no act, omission, or fault of the Consultant; (b) was lawfully in the Consultant's possession prior to disclosure by the Company, without any restriction on disclosure, as evidenced by the Consultant's contemporaneous written records; (c) is independently developed by the Consultant without reference to or reliance upon the Confidential Information, as evidenced by the Consultant's contemporaneous written records; (d) is lawfully obtained by the Consultant from a third party who is not under an obligation of confidentiality to the Company with respect to such information; or (e) is required to be disclosed by applicable law, regulation, court order, or governmental directive, provided that the Consultant shall, to the extent permitted by law, provide the Company with prompt written notice of such requirement prior to disclosure so that the Company may seek a protective order or other appropriate remedy, and the Consultant shall disclose only that portion of the Confidential Information that is legally required to be disclosed.
6.4 Return of Materials. Upon the termination or expiration of this Agreement, or at any time upon the Company's written request, the Consultant shall promptly return to the Company, or at the Company's election permanently destroy, all Confidential Information in the Consultant's possession or control, including all copies, summaries, excerpts, notes, and derivative works thereof, in any medium or format. The Consultant shall certify in writing to the Company that all such Confidential Information has been returned or destroyed, as applicable. Notwithstanding the foregoing, the Consultant may retain one (1) archival copy of Confidential Information solely as required by applicable law or professional record-keeping requirements, provided that such retained copy remains subject to the confidentiality obligations of this Article 6.
6.5 Duration. The Consultant's obligations under this Article 6 shall survive the termination or expiration of this Agreement for a period of five (5) years following the effective date of such termination or expiration; provided, however, that with respect to any Confidential Information that constitutes a trade secret under applicable law, the Consultant's confidentiality obligations shall continue for so long as such information remains a trade secret.
ARTICLE 7 — INTELLECTUAL PROPERTY
7.1 Work Product. All work product, deliverables, inventions, discoveries, improvements, designs, reports, analyses, recommendations, presentations, data compilations, and other materials of any kind or nature (collectively, "Work Product") created, conceived, developed, or reduced to practice by the Consultant, alone or jointly with others, in the performance of services under this Agreement, or that arise out of or relate to the Consultant's engagement under this Agreement, shall be the sole and exclusive property of the Company. To the extent that any Work Product constitutes a "work made for hire" within the meaning of the United States Copyright Act (17 U.S.C. § 101 et seq.), such Work Product shall be deemed a work made for hire, and the Company shall be the author thereof for all purposes.
7.2 Assignment. To the extent that any Work Product does not qualify as a work made for hire under applicable law, the Consultant hereby irrevocably assigns, transfers, and conveys to the Company all right, title, and interest in and to such Work Product, including without limitation all patents, copyrights, trademarks, trade secrets, and other intellectual property rights therein, throughout the world, in perpetuity. The Consultant shall execute and deliver to the Company, at the Company's request and expense, all documents and instruments, and shall take all further actions, as may be reasonably necessary to perfect, protect, and enforce the Company's rights in and to the Work Product, including assignments of patent applications, copyright registrations, and other intellectual property filings.
7.3 Pre-Existing IP. The Consultant retains all right, title, and interest in and to any intellectual property owned by the Consultant prior to the Effective Date or developed by the Consultant outside the scope of this Agreement and without reference to or use of the Company's Confidential Information ("Pre-Existing IP"). To the extent that any Pre-Existing IP is incorporated into or used in connection with any Work Product or deliverable provided to the Company under this Agreement, the Consultant hereby grants to the Company a non-exclusive, perpetual, irrevocable, worldwide, royalty-free, fully paid-up license, with the right to sublicense through multiple tiers, to use, reproduce, modify, distribute, display, and create derivative works of such Pre-Existing IP solely as incorporated into or used in connection with the Work Product and the Company's products and services. The Consultant shall identify in writing any Pre-Existing IP that the Consultant intends to incorporate into any Work Product prior to such incorporation and shall obtain the Company's prior written consent before incorporating any Pre-Existing IP into any deliverable.
ARTICLE 8 — COMPLIANCE REPRESENTATIONS AND WARRANTIES
8.1 General Compliance. The Consultant represents and warrants to the Company as of the Effective Date and on a continuing basis during the Term that:
(a) The Consultant shall comply with all Applicable Law in connection with the performance of services under this Agreement, including without limitation the AKS, the False Claims Act, the Physician Payments Sunshine Act, FDA regulations, and all applicable state laws and regulations governing interactions between medical device companies and healthcare professionals.
(b) The Consultant has not been, and during the Term will not be, excluded, debarred, or suspended from participation in any Federal Health Care Program, including without limitation Medicare, Medicaid, TRICARE, or any other federal or state healthcare program. The Consultant has not been placed on the OIG List of Excluded Individuals/Entities (LEIE) or the GSA System for Award Management (SAM) Excluded Parties List.
(c) The Consultant has not been convicted of, and has not entered a plea of guilty or nolo contendere to, a criminal offense related to the provision of healthcare items or services, healthcare fraud, theft, embezzlement, breach of fiduciary responsibility, financial misconduct, controlled substances, or patient abuse or neglect.
(d) The Consultant is not currently under investigation by any federal or state governmental authority in connection with healthcare fraud, abuse, or misconduct, and is not currently subject to any pending civil or administrative proceeding relating to healthcare compliance.
8.2 Anti-Kickback Compliance. The Consultant represents and warrants to the Company as of the Effective Date and on a continuing basis during the Term that:
(a) The Consultant has entered into this Agreement to provide bona fide consulting services and not for the purpose of generating, inducing, or rewarding referrals of patients, prescriptions, orders, recommendations, or other business for the Company's products or services, and the Consultant's willingness to enter into this Agreement has not been influenced by any consideration of the volume or value of any past, present, or future referrals or other business involving any Federal Health Care Program.
(b) The Consultant will not, directly or indirectly, offer, pay, solicit, or receive any remuneration, whether in cash or in kind, in exchange for or to induce the referral of patients, prescriptions, orders, recommendations, or other business involving any Federal Health Care Program in connection with this Agreement or the Consultant's relationship with the Company.
(c) The Consultant acknowledges that the compensation paid under this Agreement has been determined to reflect Fair Market Value for the services to be rendered and is not conditioned upon, related to, or determined in a manner that takes into account the volume or value of referrals or other business generated between the Parties or involving any Federal Health Care Program.
8.3 False Claims Act. The Consultant represents and warrants that the Consultant will not knowingly present or cause to be presented to any Federal Health Care Program, or any other payor, any false, fictitious, or fraudulent claim for payment or approval, and will not knowingly make, use, or cause to be made or used any false record or statement material to a false or fraudulent claim, in connection with this Agreement or the Consultant's relationship with the Company.
8.4 Sunshine Act / Open Payments Acknowledgment. The Consultant acknowledges and agrees as follows:
(a) Solstice Biomedical Inc. is an "applicable manufacturer" subject to the reporting requirements of the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h) and the CMS Open Payments program (42 C.F.R. Part 403, Subpart I).
(b) All transfers of value made by the Company to the Consultant under this Agreement, including without limitation compensation, expense reimbursements, meals, travel, lodging, and any other items of value, may be required to be reported to CMS as part of the Company's Open Payments obligations, subject to applicable reporting thresholds. For calendar year 2024, the applicable thresholds are: $12.49 per individual payment or other transfer of value, or $100.00 in aggregate per covered recipient per calendar year. The Consultant acknowledges that these thresholds may be adjusted annually by CMS.
(c) The Consultant consents to the Company's collection, use, processing, storage, and disclosure of data regarding transfers of value made to the Consultant for purposes of compliance with the Physician Payments Sunshine Act and the CMS Open Payments program, including the reporting of such data to CMS by the applicable reporting deadline (currently March 31 of the year following the reporting year) and the publication of such data through the CMS Open Payments database, which is publicly accessible.
(d) The Consultant agrees to cooperate with the Company's data collection and verification requests in connection with Sunshine Act compliance, including without limitation the timely review and confirmation of reported data during the CMS review and dispute resolution period, which currently occurs each year during the period designated by CMS (typically a forty-five (45)-day period beginning in the spring of each year).
8.5 State Law Compliance. The Consultant acknowledges that certain states and jurisdictions impose additional restrictions, requirements, and reporting obligations on interactions between medical device companies and healthcare professionals, including without limitation aggregate spend reporting requirements (e.g., California, Connecticut, Massachusetts, Minnesota, Vermont), gift ban statutes, marketing code adoption requirements, and transparency laws. The Consultant agrees to comply with all such state laws and regulations applicable to the Consultant's jurisdiction(s) of practice and licensure, and to cooperate with the Company in ensuring compliance with such state requirements, including by providing information reasonably requested by the Company for purposes of state reporting.
8.6 Ongoing Obligation to Disclose. The Consultant shall promptly notify the Company in writing, and in no event later than five (5) business days after becoming aware, if any representation or warranty set forth in this Article 8 becomes untrue, inaccurate, or misleading in any material respect during the Term, or if any event occurs or circumstances arise that could reasonably be expected to cause any such representation or warranty to become untrue, inaccurate, or misleading.
8.7 Compliance Certification. The Consultant shall execute and deliver to the Company the Compliance Certification attached hereto as Exhibit C on or before the Effective Date. The Consultant shall also execute and deliver an updated Compliance Certification annually thereafter during the Term, on or before each anniversary of the Effective Date. The failure of the Consultant to execute and deliver the Compliance Certification when due shall constitute grounds for termination of this Agreement pursuant to Section 3.5(c).
8.8 Company Representations. The Company represents and warrants to the Consultant that: (a) the Company has conducted a fair market value assessment of the compensation set forth in Exhibit B, utilizing independent benchmarking data and/or third-party valuation methodologies, and has determined that such compensation reflects Fair Market Value; (b) the Company has documented the legitimate business need for the Consultant's services in accordance with the Company's internal Legitimate Business Need Assessment process; and (c) the Company shall comply with all applicable reporting obligations under the Physician Payments Sunshine Act and the CMS Open Payments program with respect to transfers of value made to the Consultant under this Agreement.
ARTICLE 9 — INDEMNIFICATION
9.1 Consultant Indemnification. The Consultant shall indemnify, defend, and hold harmless the Company and its Affiliates, and their respective officers, directors, employees, agents, successors, and assigns (collectively, the "Company Indemnitees"), from and against any and all losses, claims, damages, liabilities, penalties, fines, costs, and expenses (including reasonable attorneys' fees and costs of investigation) (collectively, "Losses") arising out of, resulting from, or relating to: (a) the Consultant's breach of any provision of this Agreement, including any representation, warranty, or covenant set forth herein; (b) the Consultant's violation of any Applicable Law in connection with the performance of services under this Agreement; (c) the Consultant's negligent, reckless, or willful acts or omissions in connection with the performance of services under this Agreement; or (d) any claim that the Consultant's Pre-Existing IP, as incorporated into any Work Product, infringes upon the intellectual property rights of any third party.
9.2 Company Indemnification. The Company shall indemnify, defend, and hold harmless the Consultant from and against any and all Losses arising out of, resulting from, or relating to: (a) the Company's breach of any provision of this Agreement, including any representation, warranty, or covenant set forth herein; (b) the Company's violation of any Applicable Law in connection with this Agreement; or (c) the Company's negligent, reckless, or willful acts or omissions in connection with the management or oversight of the Consultant's engagement under this Agreement.
9.3 Procedure. The Party seeking indemnification (the "Indemnified Party") shall provide the indemnifying Party (the "Indemnifying Party") with: (a) prompt written notice of any claim, demand, action, or proceeding for which indemnification is sought (provided that failure to provide prompt notice shall not relieve the Indemnifying Party of its indemnification obligations except to the extent the Indemnifying Party is materially prejudiced by such failure); (b) reasonable cooperation in the defense of such claim, at the Indemnifying Party's expense; and (c) the right to assume and control the defense of such claim, with counsel reasonably acceptable to the Indemnified Party. The Indemnified Party shall have the right to participate in the defense of any claim at its own expense with counsel of its own choosing. The Indemnifying Party shall not settle any claim that would impose any liability, obligation, or restriction on the Indemnified Party without the Indemnified Party's prior written consent, which shall not be unreasonably withheld, conditioned, or delayed.
ARTICLE 10 — GENERAL PROVISIONS
10.1 Governing Law. This Agreement shall be governed by, and construed and enforced in accordance with, the laws of the Commonwealth of Massachusetts, without regard to any conflicts of law principles that would require the application of the laws of any other jurisdiction.
10.2 Dispute Resolution. Any dispute, controversy, or claim arising out of or relating to this Agreement, including the breach, termination, or validity thereof, shall be resolved by \\\\\\\\\\\\\\\\\\\\\\\\\\\\\\ (Insert: binding arbitration administered by the American Arbitration Association in accordance with its Commercial Arbitration Rules, with the place of arbitration being Boston, Massachusetts / litigation in the state or federal courts located in Suffolk County, Boston, Massachusetts, and each Party hereby irrevocably consents to the exclusive jurisdiction and venue of such courts). The prevailing Party in any such dispute shall be entitled to recover its reasonable attorneys' fees and costs from the non-prevailing Party.
10.3 Entire Agreement. This Agreement, including all Exhibits attached hereto (Exhibit A — Scope of Services, Exhibit B — Compensation Schedule, and Exhibit C — Compliance Certification), constitutes the entire agreement between the Parties with respect to the subject matter hereof and supersedes all prior and contemporaneous negotiations, representations, understandings, discussions, and agreements, whether oral or written, between the Parties with respect to such subject matter. There are no representations, warranties, covenants, or agreements between the Parties with respect to the subject matter hereof except as expressly set forth in this Agreement and the Exhibits hereto.
10.4 Amendments. No amendment, modification, supplement, or waiver of any provision of this Agreement shall be effective unless made in writing and signed by both Parties. Any amendment relating to the Scope of Services, compensation terms, or compliance provisions shall require the prior written approval of the Company's Legal Department and/or Compliance Department.
10.5 Assignment. The Consultant may not assign this Agreement or delegate any duties or obligations hereunder, in whole or in part, without the prior written consent of the Company, and any purported assignment or delegation without such consent shall be void and of no effect. The Company may assign this Agreement, in whole or in part, to any Affiliate without the Consultant's consent, and may assign this Agreement to any successor entity in connection with a merger, acquisition, reorganization, or sale of substantially all of the Company's assets, upon written notice to the Consultant.
10.6 Severability. If any provision of this Agreement, or the application of any provision to any Person or circumstance, is held by a court of competent jurisdiction or arbitrator to be invalid, illegal, or unenforceable in any respect, such invalidity, illegality, or unenforceability shall not affect any other provision of this Agreement, and the remaining provisions shall remain in full force and effect. The Parties shall negotiate in good faith a valid and enforceable substitute provision that most closely approximates the intent and economic effect of the invalid, illegal, or unenforceable provision.
10.7 Waiver. The failure of either Party to enforce any provision of this Agreement at any time, or to exercise any right or remedy under this Agreement, shall not constitute a waiver of such provision, right, or remedy, and shall not affect the right of such Party to enforce such provision or exercise such right or remedy at a later time. No waiver shall be effective unless made in writing and signed by the waiving Party.
10.8 Notices. All notices, requests, demands, consents, and other communications required or permitted under this Agreement shall be in writing and shall be deemed to have been duly given: (a) when delivered personally; (b) upon confirmation of receipt when sent by electronic mail to the email address specified below, provided that a copy is also sent by one of the other methods specified herein; (c) one (1) business day after deposit with a nationally recognized overnight courier service, prepaid; or (d) three (3) business days after deposit in the United States mail, first class, certified or registered, return receipt requested, postage prepaid. All notices shall be addressed to the Parties at the addresses set forth below, or to such other address as a Party may designate by notice given in accordance with this Section:
If to the Company:
Solstice Biomedical Inc. 200 Harborview Drive, Suite 1100 Boston, MA 02210
Attention: General Counsel
Email: legalnotices@solsticebiomedical.com
With a copy to:
Head of Global Compliance Solstice Biomedical Inc. 200 Harborview Drive, Suite 1100 Boston, MA 02210
Email: compliance@solsticebiomedical.com
If to the Consultant:
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Email: \\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\
10.9 Counterparts. This Agreement may be executed in two or more counterparts, each of which shall be deemed an original and all of which together shall constitute one and the same instrument. Execution and delivery of this Agreement by exchange of facsimile or electronically transmitted signatures (including signatures transmitted in PDF format) shall constitute valid and sufficient execution and delivery for all purposes.
10.10 Compliance Program Cooperation. The Consultant agrees to cooperate fully with the Company's compliance program, including without limitation: (a) responding promptly and truthfully to compliance inquiries from the Company's Legal Department, Compliance Department, or outside counsel; (b) participating in compliance audits and reviews as reasonably requested by the Company; (c) reporting any known or suspected violations of Applicable Law, this Agreement, or the Company's Code of Conduct through the Company's compliance hotline, which is operated by Clearpath Ethics Services Inc. and allows for confidential and anonymous reporting (telephone: 1-800-555-0199; web portal: www.clearpath-ethics.com/solstice); and (d) cooperating with any investigation conducted by the Company or any governmental authority relating to the subject matter of this Agreement.
10.11 Monitoring and Audit. The Company reserves the right to monitor and audit the Consultant's compliance with this Agreement and Applicable Law at any time during the Term and for a period of six (6) years following the termination or expiration of this Agreement. Such monitoring and audit rights include, without limitation, the right to review the Consultant's time records, deliverables, invoices, expense documentation, and compliance certifications, and to conduct interviews with the Consultant regarding the services performed under this Agreement. The Consultant shall cooperate fully with any such monitoring or audit and shall provide the Company with access to all relevant records and information within a reasonable time following a written request.
IN WITNESS WHEREOF, the Parties have executed this Physician Consulting Agreement as of the date first written above.
SOLSTICE BIOMEDICAL INC.
By: ________
Name: ________
Title: ________
Date: ________
CONSULTANT
By: ________
Name: ________, M.D./D.O.
Date: ________
NPI Number: ________ State Medical License No.: ________ Specialty: ________
EXHIBIT A
SCOPE OF SERVICES
INSTRUCTIONAL HEADER: To be completed by the requesting business unit in consultation with the Legal Department and/or Compliance Department. Each engagement must document the specific, legitimate business need for the Consultant's services. This Exhibit A shall not be executed until all fields have been completed with specificity sufficient to satisfy the requirements of the AKS personal services and management contracts safe harbor. All fields designated with brackets must be replaced with actual content prior to execution.
A.1 Legitimate Business Need Statement
Business Purpose: \\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\
Insert above a description of the legitimate, bona fide business purpose for which consulting services are needed. The business need must be independent of any referral or purchasing relationship between the Company and the Consultant, and must not be conditioned upon or related to the volume or value of any past, present, or future business generated by the Consultant for the Company.
Examples of Permissible Purposes (for reference only — do not include in executed version):
• Clinical advisory input on product design, development, or improvement
• Medical education program development and content review
• Clinical outcomes research consultation and study design
• Post-market surveillance advisory services
• Market research participation, including advisory boards and focus groups
• Training program development for healthcare professionals or Company personnel
• Review and commentary on clinical data, manuscripts, or publications
• User experience evaluation and human factors assessment
A.2 Description of Services
Services to Be Performed: \\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\
Insert above a detailed description of the specific tasks, deliverables, and activities to be performed by the Consultant. Services must be described with sufficient specificity to demonstrate that they are bona fide and to allow the Company to verify that services have been satisfactorily performed. Vague or general descriptions (e.g., "consulting services" or "advisory input") are not sufficient.
A.3 Deliverables. Deliverables:
Insert additional rows as necessary. Each deliverable must have clearly defined acceptance criteria to enable verification of satisfactory performance.
A.4 Schedule and Estimated Hours
Schedule of Services:
Total Estimated Hours for the Term: \\\\\\\\\\
The aggregate services, schedule, intervals, and hours must be specified in advance in this Exhibit A, consistent with the requirements of the AKS personal services and management contracts safe harbor (42 C.F.R. § 1001.952(d)). If services are to be provided on a periodic, sporadic, or part-time basis, the exact schedule of such intervals, their precise length, and the exact charge for such intervals must be stated above.
A.5 Location of Services
Location(s) where services will be performed:
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Insert location(s), e.g., Company offices (200 Harborview Drive, Suite 1100, Boston, MA 02210), Consultant's office, virtual meetings via Calderon Software or Northgate Data Systems, or other specified locations. If services are to be performed at a location other than the Company's offices or the Consultant's office, provide justification for the selected venue.
A.6 Term of Services
Start Date: \\\\\\\\\\\\\\\\\\\\\\\\
End Date: \\\\\\\\\\\\\\\\\\\\\\\\