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Penterra Pharmaceuticals Corp
M&A / Corporate
Document types detected
Analysis / memo5
Pleading / procedure4
Engagement letter2
Other1
Parties across the matter
Associates LLPBecause Penterra Pharmaceuticals CorpCole CPAs LLPGeneral Counsel Penterra Pharmaceuticals CorpHARKNESS LLPHarkness LLPKeswick Bioanalytics IncM. WitherspoonMedical Officer Penterra Pharmaceuticals CorpOF LETTER Penterra Pharmaceuticals CorpPenterra Pharmaceuticals CorpRegulatory Affairs Penterra Pharmaceuticals CorpRidgeline Health Analytics LLCTavrenis Stern Consulting Group LLC
Chronology
2024-03-18 · matter-closing-memo.docx
… way & March") as its successor promotional-services agency, effective March 18, 2024. The Calloway & March engagement letter incorporates enhanced compliance requirements, in …
2024-03-15 · matter-closing-memo.docx
… Agreement dated March 15, 2021, the termination becomes effective on March 15, 2024. The decision to terminate Ridgeline reflected the Firm's findings, discussed in the inte …
2024-02-28 · corrective-dhcp-letter.docx
… his retraining must be completed by all representatives no later than February 28, 2024, and documentation of completion will be maintained in Penterra's compliance records. Pen …
2024-02-28 · securities-disclosure-advice-memo.docx
… Form 10-K, which we understand is anticipated to be filed on or about February 28, 2024. 3. Auditor Coordination. The Company should coordinate with its independent registered …
2024-02-22 · matter-closing-memo.docx
… KNESS LLP 600 Lexington Avenue New York, NY 10022 INTERNAL MEMORANDUM February 22, 2024 TO: Leonard Cross, Responsible Partner (Tax) Nathaniel Bower, Billing Partner (Bankruptcy …
2024-02-19 · matter-closing-memo.docx
… y 22, 2024. The FDA issued its close-out and acknowledgment letter on February 19, 2024, confirming that the agency considers the matter resolved on the basis of Penterra's comp …
2024-01-31 · matter-closing-memo.docx
… earning-management system, and a 100% completion rate was achieved by January 31, 2024. 5. Termination of Ridgeline Health Analytics LLC. Penterra issued a notice of terminati …
2024-01-15 · matter-closing-memo.docx
… xtension on November 8, 2023, establishing a new response deadline of January 15, 2024. C. Engagement Team and Co-Counsel The Calderwood & Harkness LLP engagement team for this …
2024-01-15 · draft-fda-response-letter.docx
… consumers. This response is submitted within the extended deadline of January 15, 2024, as granted by OPDP on November 8, 2023, following Penterra's formal extension request da …
2024-01-15 · fda-extension-request-letter.docx
… terra respectfully requests that the response deadline be extended to January 15, 2024. I am Margaret Tan, Executive Vice President and General Counsel of Penterra, and I am wr …
2024-01-15 · co-counsel-engagement-letter-whitfield-bauer.docx
… establishing a new deadline for Penterra's formal written response of January 15, 2024. 2.4 Voluntary Withdrawal of Cited Materials Penterra, on the advice of C&H and in consul …
2024-01-15 · internal-investigation-plan-memo.docx
… r 8, 2023, OPDP granted the extension, establishing a new deadline of January 15, 2024 for Penterra's formal response. This extension provides the necessary time to conduct a t …
2024-01-15 · preliminary-assessment-memo.docx
… 3, seeking to extend the response deadline from November 15, 2023, to January 15, 2024. As of the date of this memorandum, OPDP's decision on that extension request remains pen …
2024-01-15 · promotional-labeling-compliance-memo.docx
… e original response deadline, extending it from November 15, 2023, to January 15, 2024, pursuant to Penterra's request submitted on November 1, 2023, and granted by OPDP on Nov …
2024-01-15 · securities-disclosure-advice-memo.docx
… anted by OPDP on November 8, 2023, extending the response deadline to January 15, 2024. All three cited promotional materials were developed as part of a coordinated marketing …
2024-01-12 · matter-closing-memo.docx
… ve seven-point corrective action plan submitted as part of Penterra's January 12, 2024 formal response letter. The response strategy — which emphasized voluntary and proactive …
2024-01-12 · draft-fda-response-letter.docx
… shington, DC 20036, for Penterra's signature. Final version submitted January 12, 2024. Dr. Carla M. Witherspoon, Pharm.D. Regulatory Review Officer Office of Prescription Drug …
2024-01-12 · internal-investigation-plan-memo.docx
… ry 5, 2024. The formal response to OPDP is targeted for submission by January 12, 2024, three days in advance of the January 15, 2024 deadline. II. Background A. The OPDP Inqui …
2024-01-05 · draft-fda-response-letter.docx
… PHARMACEUTICALS CORP. 480 Overlook Drive, Suite 700 Summit, NJ 07901 January 5, 2024 Prepared by Calderwood & Harkness LLP, 600 Lexington Avenue, New York, NY 10022 (Matter N …
2024-01-05 · internal-investigation-plan-memo.docx
… esponse letter incorporating investigation findings to be prepared by January 5, 2024. The formal response to OPDP is targeted for submission by January 12, 2024, three days i …
2024-01-02 · matter-closing-memo.docx
… ocedures. Penterra adopted and implemented revised PRC SOPs effective January 2, 2024. The revised SOPs incorporate several significant changes, including: (a) a requirement f …
2024-01-02 · corrective-dhcp-letter.docx
… nal Review Committee ("PRC") standard operating procedures. Effective January 2, 2024, Penterra's PRC standard operating procedures will require unanimous Medical Affairs sign …
2023-12-20 · internal-investigation-plan-memo.docx
… 3, a final Investigation Findings Memorandum delivered to Penterra by December 20, 2023, and a draft FDA response letter incorporating investigation findings to be prepared by J …
2023-12-20 · internal-investigation-findings-memo.docx
… OUT PRIOR AUTHORIZATION OF CALDERWOOD & HARKNESS LLP MEMORANDUM Date: December 20, 2023 To: Leonard Cross, Responsible Partner, Calderwood & Harkness LLP Margaret Tan, Executive …
2023-12-18 · matter-closing-memo.docx
… a issued a notice of termination to Ridgeline Health Analytics LLC on December 18, 2023. In accordance with the 90-day termination clause in the Master Services Agreement dated …
2023-12-18 · internal-investigation-findings-memo.docx
… er a period of approximately six weeks, from November 8, 2023 through December 18, 2023. This memorandum sets forth the principal findings of the investigation, the evidentiary …
2023-12-15 · internal-investigation-plan-memo.docx
… raft Investigation Findings Memorandum to be circulated internally by December 15, 2023, a final Investigation Findings Memorandum delivered to Penterra by December 20, 2023, an …
2023-12-11 · matter-closing-memo.docx
… r Healthcare Provider" Letter. A corrective communication was sent on December 11, 2023, to the approximately 42,000 neurologists and primary-care physicians who had received th …
2023-12-11 · corrective-dhcp-letter.docx
… S CORP. [Company Logo] 480 Overlook Drive, Suite 700 Summit, NJ 07901 December 11, 2023 Dear Healthcare Provider: This letter is being sent to approximately 42,000 neurologists …
2023-12-11 · internal-investigation-findings-memo.docx
… ew sessions involving eight individuals between November 28, 2023 and December 11, 2023. All interviews of Penterra employees were conducted under Upjohn / corporate-Miranda war …
2023-12-10 · internal-investigation-plan-memo.docx
… l warnings. The target date for completion of all four workstreams is December 10, 2023, with a draft Investigation Findings Memorandum to be circulated internally by December 1 …
2023-12-05 · internal-investigation-findings-memo.docx
… count Lead for Penterra, Ridgeline Health Analytics LLC — interviewed December 5, 2023. Ms. Chu's interview was conducted with Penterra's consent and Ridgeline's cooperation. M …
2023-12-04 · promotional-labeling-compliance-memo.docx
… evision as additional information becomes available. MEMORANDUM DATE: December 4, 2023 TO: Margaret Tan, Executive Vice President & General Counsel, Penterra Pharmaceuticals Co …
2023-11-30 · internal-investigation-findings-memo.docx
… t, Pharm.D., Senior Director, Medical Affairs, Penterra — interviewed November 30, 2023. Dr. Gerhardt was interviewed regarding her objection to the truncated y-axis in ZVR-2023 …
2023-11-29 · internal-investigation-findings-memo.docx
… nwick, Director, Promotional Review Committee, Penterra — interviewed November 29, 2023. Mr. Renwick was interviewed regarding the PRC's review and approval of the three cited m …
2023-11-28 · internal-investigation-findings-memo.docx
… conducted six interview sessions involving eight individuals between November 28, 2023 and December 11, 2023. All interviews of Penterra employees were conducted under Upjohn / …
2023-11-15 · matter-closing-memo.docx
… a. The original response deadline set forth in the inquiry letter was November 15, 2023, providing thirty (30) days from the date of receipt by Penterra. On November 1, 2023, Ca …
2023-11-15 · fda-extension-request-letter.docx
… urrent thirty (30)-day response period, Penterra's response is due on November 15, 2023. By this letter, Penterra respectfully requests that the response deadline be extended to …
2023-11-15 · co-counsel-engagement-letter-whitfield-bauer.docx
… The OPDP inquiry letter established an original response deadline of November 15, 2023, which was thirty (30) days from the date of Penterra's receipt of the inquiry on October …
2023-11-15 · engagement-letter-penterra.docx
… ated in the OPDP Inquiry, the Company's original response deadline is November 15, 2023, which is thirty (30) calendar days from the date of the Company's receipt of the Inquiry …