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Contract analysis / remaining-issues-resolution-memo.docx
remaining-issues-resolution-memo.docx
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I. Purpose and Executive Summary
High
⚑ Indemnity / guarantee obligation
I. Purpose and Executive Summary This memorandum documents the final resolution of all remaining open issues in the Master Clinical Trial Agreement (the "MCTA") between Penterra Pharmaceuticals Corp. ("Penterra" or "Sponsor") and Veridian Health Research Network, Inc. ("Veridian" or the "Network") for Protocol PPC-4871-III, known by the trial acronym CLARION (Clinical Assessment of Response with Longitudinal Investig
II. Background and Procedural History
High
⚑ Non-compete / exclusivity restraint
II. Background and Procedural History The following summary outlines the procedural history of the MCTA negotiation from the opening of the Calderwood & Harkness matter through the present date. This history is provided for context and to establish a complete record of the negotiation process. March 20, 2023: Calderwood & Harkness LLP opened Matter No. 1018-00004 on behalf of Penterra Pharmaceuticals Corp. to represe
III. Issue 1: Termination Wind-Down Payment Obligations
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⚑ Unilateral / for-convenience termination
III. Issue 1: Termination Wind-Down Payment Obligations A. Nature of the Issue The near-final draft of the MCTA (dated June 16, 2023) included a one hundred twenty (120)-day wind-down period following any termination of the agreement, whether such termination is for cause (material breach), for convenience (upon ninety (90) days' prior written notice), or upon mutual written agreement of the parties. The wind-down pe
IV. Issue 2: Subject Transition Procedures Upon Early Termination
High
⚑ Indemnity / guarantee obligation
IV. Issue 2: Subject Transition Procedures Upon Early Termination A. Nature of the Issue Although the near-final draft of the MCTA established the 120-day wind-down period and set forth certain general principles regarding the orderly conclusion of trial activities, it did not fully specify the procedures for transitioning subjects who are mid-treatment at the time of termination. This gap was identified as a critica
V. Issue 3: Medically Necessary Protocol Deviations and Indemnification Carve-Out Interpla
High
⚑ Indemnity / guarantee obligation
V. Issue 3: Medically Necessary Protocol Deviations and Indemnification Carve-Out Interplay A. Nature of the Issue The near-final draft of the MCTA contained a standard sponsor indemnification provision, under which Penterra agrees to indemnify, defend, and hold harmless Veridian, its participating sites, and their respective investigators, officers, directors, employees, and agents from and against losses, damages,
VI. Summary of All Resolved Issues and MCTA Status
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⚑ Indemnity / guarantee obligation
VI. Summary of All Resolved Issues and MCTA Status A. Comprehensive Issue Resolution Table The following table provides a comprehensive summary of all substantive issues that were raised during the negotiation of the MCTA, the positions of the respective parties, the agreed resolution, and the date on which each issue was resolved. This table is intended to serve as a reference document for the negotiation history an
VII. Next Steps and Timeline to Execution
High
⚑ Indemnity / guarantee obligation
VII. Next Steps and Timeline to Execution The following timeline sets forth the key milestones for finalization and execution of the MCTA. All dates are target dates and are subject to adjustment based on the availability of the authorized signatories and the timely delivery of conditions precedent. June 21–22, 2023: Christopher Aiken and Sean Morrissey will prepare conforming revisions to the MCTA, incorporating the
VIII. Action Items
VIII. Action Items The following table sets forth all outstanding action items required to finalize and execute the MCTA. Each action item is assigned to a responsible individual with a corresponding deadline.
IX. Conclusion
High
⚑ Indemnity / guarantee obligation
IX. Conclusion All substantive and drafting issues in the Master Clinical Trial Agreement between Penterra Pharmaceuticals Corp. and Veridian Health Research Network, Inc. for Protocol PPC-4871-III (CLARION) have been resolved through the telephone conferences of June 19 and June 20, 2023, between Miriam Calloway of Calderwood & Harkness LLP and Allison Whitmore of Whitmore, Jansen & Callahan LLP. The three final ope