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Solstice Biomedical Devices Ltd Litigation 12 docs · open →

Document types detected

Analysis / memo5

Contract / agreement3

Engagement letter2

Pleading / procedure1

Other1

Parties across the matter

Advisory LLPAscendant Distribution Solutions LLCBetween Solstice Biomedical Devices LtdGlobal Compliance Solstice Biomedical IncHARKNESS LLPHarkness LLPMeridian Consulting Group LLCPROGRAM AGREEMENT Solstice Biomedical IncPaige LLPSURVEY OF STATE SASecretary Solstice Biomedical Devices LtdSolstice Biomedical Devices LtdSolstice Biomedical IncVantage Medical Technologies Inc

Chronology

2026-03-31 · state-marketing-compliance-survey.docx

… to CMS by March 31, 2025; full calendar year 2025 data will be due by March 31, 2026. AdvaMed Code of Ethics. SBI has adopted the AdvaMed Code of Ethics on Interactions with …

2026-03-31 · sunshine-act-compliance-memo.docx

… data (January 1 through December 31, 2025) must be reported to CMS by March 31, 2026. Calderwood & Harkness estimates that the CY2024 portion of total Year-1 transfers will b …

2025-12-31 · anti-kickback-and-fca-analysis-memo.docx

… projected US Year-1 revenue is $26 million for the fiscal year ending December 31, 2025. These revenue projections form the baseline for the financial assumptions underlying the …

2025-12-31 · fda-promotional-review-memo.docx

… projects US Year-1 revenue of $26 million for the fiscal year ending December 31, 2025, based on the planned October 1, 2024 commercial launch of the Pulsar™ CRM System in the …

2025-12-31 · sales-compensation-analysis.docx

… ear-1 revenue of approximately $26 million for the fiscal year ending December 31, 2025. These revenue projections are based on market penetration models developed by Solstice's …

2025-12-31 · sunshine-act-compliance-memo.docx

… be reported to CMS by March 31, 2025. CY2025 data (January 1 through December 31, 2025) must be reported to CMS by March 31, 2026. Calderwood & Harkness estimates that the CY20 …

2025-12-31 · comprehensive-compliance-framework-report.docx

… ear-1 revenue of approximately $26 million for the fiscal year ending December 31, 2025. The scope of C&H's engagement encompassed a thorough analysis of the full spectrum of fe …

2025-03-31 · state-marketing-compliance-survey.docx

… . Calendar year 2024 data (October through December) is due to CMS by March 31, 2025; full calendar year 2025 data will be due by March 31, 2026. AdvaMed Code of Ethics. SBI …

2025-03-31 · sunshine-act-compliance-memo.docx

… d implementation timeline keyed to the October 1, 2024 launch and the March 31, 2025 CMS reporting deadline for CY2024 data. Throughout this memorandum, we have identified sp …

2025-03-31 · email-strauss-to-harrington-final-deliverables.eml

… calendar year. Data for calendar year 2024 must be reported to CMS by March 31, 2025. I note that the CMS Manufacturer ID application was submitted in June 2024, and I would …

2025-03-31 · engagement-letter-solstice-compliance-review.docx

… confirmation that calendar year 2024 data must be submitted to CMS by March 31, 2025, and identification of applicable data review and dispute resolution windows. (vii) Analy …

2024-12-31 · sunshine-act-compliance-memo.docx

… his figure reflects both the partial CY2024 period (October 1 through December 31, 2024) and the anticipated full CY2025 operations, though the first CMS reporting obligation wi …

2024-10-01 · anti-kickback-and-fca-analysis-memo.docx

… 3729–3733. This analysis is being provided in advance of the planned October 1, 2024 US commercial launch of the Pulsar™ CRM System. Product Context. The Pulsar™ CRM System i …

2024-10-01 · distributor-compliance-review-memo.docx

… first commercial launch in the United States, presently scheduled for October 1, 2024. The US market represents a critical expansion milestone for Solstice, with projected Yea …

2024-10-01 · fda-promotional-review-memo.docx

… e" or the "Company") intends to deploy in connection with the planned October 1, 2024 commercial launch of the Pulsar™ CRM System (the "Pulsar" or the "Device") in the United …

2024-10-01 · sales-compensation-analysis.docx

… United States commercial organization in connection with the planned October 1, 2024 launch of the Pulsar™ CRM System (FDA 510(k) No. K232847, Class II, Product Code MHX). So …

2024-10-01 · state-marketing-compliance-survey.docx

… ythm Management System (the "Pulsar™ CRM System" or the "Product") on October 1, 2024. SBI is a wholly owned subsidiary of Solstice Biomedical Devices Ltd. ("SBD" or the "Pare …

2024-10-01 · sunshine-act-compliance-memo.docx

… e commercial launch of its first US product. SBI is preparing for the October 1, 2024 US commercial launch of the Pulsar™ CRM System, an FDA 510(k)-cleared (No. K232847, clear …

2024-10-01 · email-strauss-to-harrington-final-deliverables.eml

… en able to bring the substantive work to completion well ahead of the October 1, 2024 launch date, giving the team approximately seven weeks for implementation. Please find a …

2024-10-01 · email-whitfield-to-hitchens-distributor-amendments.eml

… 7, Class II, Product Code MHX). In preparation for Solstice's planned October 1, 2024 US commercial launch, our team has been conducting a comprehensive US sales and marketing …

2024-10-01 · comprehensive-compliance-framework-report.docx

… planned date for the US commercial launch of the Pulsar CRM System is October 1, 2024, and Solstice projects US Year-1 revenue of approximately $26 million for the fiscal year …

2024-10-01 · engagement-letter-solstice-compliance-review.docx

… Company's target date for the US commercial launch of the Product is October 1, 2024. The engagement will encompass a thorough review and analysis of SBD's planned US promoti …

2024-09-27 · fda-promotional-review-memo.docx

… recommend submission of the complete Form 2253 package no later than September 27, 2024. • We strongly recommend the establishment of a formal Medical-Legal-Regulatory ("MLR") …

2024-08-15 · distributor-compliance-review-memo.docx

… with a target completion date for final negotiation and execution of August 15, 2024—well in advance of the October 1, 2024 commercial launch date. II. Background A. The Part …

2024-08-15 · comprehensive-compliance-framework-report.docx

… 12, 2024 Matter Number: 1037-00003 Engagement Period: April 8, 2024 – August 15, 2024 ATTORNEY-CLIENT PRIVILEGED & CONFIDENTIAL ATTORNEY WORK PRODUCT CONFIDENTIALITY AND PRIVI …

2024-08-12 · email-strauss-to-harrington-final-deliverables.eml

… nd Marketing Compliance Framework — Final Report and Recommendations (August 12, 2024)** This is the comprehensive final report synthesizing all workstreams of the engagement …

2024-08-12 · comprehensive-compliance-framework-report.docx

… e Sciences Amy Whitfield, Associate, Healthcare & Life Sciences Date: August 12, 2024 Matter Number: 1037-00003 Engagement Period: April 8, 2024 – August 15, 2024 ATTORNEY-CLI …

2024-07-22 · email-whitfield-to-hitchens-distributor-amendments.eml

… omments on the proposed amendments within 15 business days—i.e., by **July 22, 2024**. Given the October 1, 2024 planned US commercial launch date, it is important that we f …

2024-07-18 · sales-compensation-analysis.docx

… hcare & Life Sciences Practice Group, Calderwood & Harkness LLP DATE: July 18, 2024 RE: Compliance Analysis of Proposed US Sales Compensation Plan — Anti-Kickback Statute Em …

2024-07-15 · fda-promotional-review-memo.docx

… Partner, Healthcare & Life Sciences, Calderwood & Harkness LLP DATE: July 15, 2024 RE: FDA Promotional and Advertising Compliance Review — Pulsar™ CRM System (510(k) No. K2 …

2024-07-15 · sunshine-act-compliance-memo.docx

… hcare & Life Sciences Practice Group, Calderwood & Harkness LLP Date: July 15, 2024 Re: Physician Payments Sunshine Act (Open Payments) Compliance Framework — Solstice Biome …

2024-07-01 · distributor-compliance-review-memo.docx

… transmit the proposed amendments to ADS's counsel during the week of July 1, 2024, with a target completion date for final negotiation and execution of August 15, 2024—wel …

2024-06-25 · distributor-compliance-review-memo.docx

… FROM: Amy Whitfield, Lead Associate, Calderwood & Harkness LLP DATE: June 25, 2024 RE: Compliance Review of Distribution Agreement Between Solstice Biomedical Devices Ltd. …

2024-06-14 · anti-kickback-and-fca-analysis-memo.docx

… Partner, Healthcare & Life Sciences, Calderwood & Harkness LLP DATE: June 14, 2024 RE: Federal Anti-Kickback Statute and False Claims Act Analysis — Solstice Biomedical Inc …

2024-06-10 · email-strauss-to-harrington-final-deliverables.eml

… e hotline operated by Clearpath Ethics Services Inc. (contract signed June 10, 2024; Ref. CP-SBD-2024-061; annual cost $18,500) should be activated and communicated to all U …

2024-04-08 · distributor-compliance-review-memo.docx

… ctober 1, 2024. D. Scope of This Review This engagement was opened on April 8, 2024, under Calderwood & Harkness LLP Matter No. 1037-00003, pursuant to an engagement letter …

2024-04-08 · email-strauss-to-harrington-final-deliverables.eml

… Pulsar™ CRM System. As you will recall, we opened this engagement on April 8, 2024, under Matter No. 1037-00003, and I am gratified that we have been able to bring the subs …

2024-04-08 · comprehensive-compliance-framework-report.docx

… es Date: August 12, 2024 Matter Number: 1037-00003 Engagement Period: April 8, 2024 – August 15, 2024 ATTORNEY-CLIENT PRIVILEGED & CONFIDENTIAL ATTORNEY WORK PRODUCT CONFIDE …

2024-04-05 · distributor-compliance-review-memo.docx

… ess LLP Matter No. 1037-00003, pursuant to an engagement letter dated April 5, 2024, executed between Calderwood & Harkness and Solstice Biomedical Devices Ltd. This memoran …

2024-04-05 · email-strauss-to-harrington-final-deliverables.eml

… ithin the $325,000 fee cap established in our engagement letter dated April 5, 2024. A final invoice will follow under separate cover from Miriam Calloway. --- **V. AVAILA …