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Contract analysis / staffing-budget-estimate-memo.docx
staffing-budget-estimate-memo.docx
High · 5
Medium · 5
Standard · 2
I. EXECUTIVE SUMMARY
High
⚑ Indemnity / guarantee obligation
I. EXECUTIVE SUMMARY The purpose of this memorandum is to set forth the projected staffing plan, estimated attorney hours, and anticipated costs for Calderwood & Harkness LLP's ("C&H" or the "Firm") representation of Penterra Pharmaceuticals Corp. ("Penterra" or "PPC") in the negotiation, drafting, and closing of a Master Clinical Trial Agreement ("MCTA") and related site-network agreements with Veridian Health Resea
II. ENGAGEMENT TEAM — STAFFING ASSIGNMENTS
Medium
⚑ Assignment / subcontracting
II. ENGAGEMENT TEAM — STAFFING ASSIGNMENTS The engagement team has been structured to provide Penterra with senior-level strategic guidance while ensuring cost-effective utilization of associate and paralegal resources for the substantial drafting, research, and document management requirements of this matter. The staffing assignments are set forth below. A. Partner-Level Staffing
1. Miriam Calloway — Responsible Partner
High
⚑ Indemnity / guarantee obligation
1. Miriam Calloway — Responsible Partner Miriam Calloway will serve as the Responsible Partner on this engagement, providing overall matter supervision, strategic direction, and serving as the lead negotiator on key commercial and indemnification terms. As the head of the Healthcare & Life Sciences Practice Group's clinical trial contracting sub-practice, Ms. Calloway brings extensive experience in multi-site clinica
2. Joel Strauss — Billing Partner
Medium
⚑ Liability cap to check against exposure
2. Joel Strauss — Billing Partner Joel Strauss will serve as the Billing Partner on this engagement, with responsibility for budget oversight, fee arrangement compliance, and client billing coordination. Mr. Strauss's involvement will be primarily administrative in nature, ensuring that the Firm's invoicing practices comply with the terms of the engagement letter and Penterra's outside counsel billing guidelines. Mr.
1. Sean Morrissey — Lead Associate
High
⚑ Indemnity / guarantee obligation
1. Sean Morrissey — Lead Associate Sean Morrissey, a sixth-year associate in the Healthcare & Life Sciences Practice Group, will serve as the Lead Associate on this matter. Mr. Morrissey has substantial experience in clinical trial agreements, having served as lead associate on fourteen multi-site MCTA transactions over the past three years, including the Penterra/Solaris Health Sciences MCTA for Protocol PPC-3219-II
2. Christopher Aiken — Working Associate
High
⚑ Indemnity / guarantee obligation
2. Christopher Aiken — Working Associate Christopher Aiken, a fourth-year associate in the Healthcare & Life Sciences Practice Group, will serve as the Working Associate on this matter. Mr. Aiken has developed particular expertise in FDA regulatory compliance matters and clinical trial site network structures, having recently completed a secondment to Penterra's Clinical Legal Affairs department (October–December 202
III. MATTER PHASES AND ESTIMATED HOURS
High
⚑ Non-compete / exclusivity restraint
III. MATTER PHASES AND ESTIMATED HOURS The engagement has been organized into seven distinct phases, several of which will run concurrently during the later stages of the project. The phase structure, scope of work, and estimated hours for each timekeeper are set forth below. All date estimates are approximate and may shift based on the pace of negotiations and counterparty responsiveness. A. Phase 1: Preliminary Ana
IV. TOTAL ESTIMATED HOURS — SUMMARY TABLE
IV. TOTAL ESTIMATED HOURS — SUMMARY TABLE The following table summarizes the total estimated hours for each timekeeper across all seven phases of the engagement: The hour estimates above reflect the engagement team's current assessment of the scope and complexity of the matter based on the information available as of the date of this memorandum. As discussed further in Section VI below, actual hours may vary dependin
V. ESTIMATED FEES AND EXPENSES
Medium
⚑ Forum / governing law
V. ESTIMATED FEES AND EXPENSES A. Attorney Fee Estimates The following hourly rates are applicable to this engagement, as set forth in the engagement letter dated March 20, 2023, and consistent with Penterra's approved rate schedule: Based on the estimated hours set forth in Section IV above, the projected fees for each timekeeper are as follows: To account for variability in negotiation complexity and potential scop
VI. ASSUMPTIONS AND CAVEATS
Standard
⚑ Commercial term
VI. ASSUMPTIONS AND CAVEATS The estimates set forth in this memorandum are based on the following assumptions and are subject to the caveats noted below. Any material deviation from these assumptions may result in actual fees and hours that differ from the estimates provided herein.
1. Negotiation Trajectory. The estimate assumes a standard negotiation trajectory consist
1. Negotiation Trajectory. The estimate assumes a standard negotiation trajectory consisting of no more than three (3) full markup rounds plus one (1) in-person negotiation session. If additional markup rounds or negotiation sessions are required, the estimated hours for Phase 3 will increase accordingly.
2. Counterparty Engagement. The estimate assumes that Veridian and its counsel, WJC, will
2. Counterparty Engagement. The estimate assumes that Veridian and its counsel, WJC, will engage constructively in the negotiation process and will respond to draft submissions and correspondence within reasonable timeframes (generally, two to three weeks per markup round). Delays in counterparty responsiveness may extend the overall project timeline but are not expected to materially increase the total hours require
3. Regulatory Stability. The estimate does not account for the potential impact of an FDA
3. Regulatory Stability. The estimate does not account for the potential impact of an FDA clinical hold on IND 157823, IND amendments, or protocol amendments that could materially alter the scope of the MCTA or the complexity of the regulatory compliance analysis. In the event of an FDA clinical hold or a significant protocol amendment during the course of this engagement, substantial additional work may be required
4. Litigation and Disputes. The estimate does not include any hours for litigation, arbit
Medium
⚑ Forum / governing law
4. Litigation and Disputes. The estimate does not include any hours for litigation, arbitration, or dispute resolution proceedings. In the unlikely event that a dispute arises during the negotiation process that requires formal dispute resolution, such work would be separately scoped and budgeted.
5. Site Count and Enrollment. The estimate is based on the current plan for thirty-eight
Standard
⚑ Commercial term
5. Site Count and Enrollment. The estimate is based on the current plan for thirty-eight (38) participating sites and an enrollment target of 1,200 subjects. If additional sites are added to the Veridian network for the CLARION trial beyond the initial thirty-eight, or if the enrollment target changes materially, additional work will be required to prepare additional site joinder agreements, update the MCTA schedules
6. Midpoint Budget Review. The budget will be reviewed at the approximate midpoint of the
6. Midpoint Budget Review. The budget will be reviewed at the approximate midpoint of the negotiation process — currently projected for late May 2023 — and will be updated if the matter trajectory differs materially from the projections set forth herein. Ms. Calloway and Mr. Strauss will confer at that time to assess actual hours against the budget and to determine whether any adjustments to the staffing plan or budg
7. Payment Terms. Payment terms for Calderwood & Harkness invoices are Net 30 days from t
7. Payment Terms. Payment terms for Calderwood & Harkness invoices are Net 30 days from the date of invoice, consistent with the terms of the engagement letter and Penterra's standard payment practices.
VII. APPROVAL AND DISTRIBUTION
Medium
⚑ Liability cap to check against exposure
VII. APPROVAL AND DISTRIBUTION This memorandum is submitted for Miriam Calloway's review and approval. Upon Ms. Calloway's approval, this memorandum will serve as the internal staffing and budget framework for the engagement. The following distribution and approval procedures are noted: Client Distribution. A summary version of this memorandum, excluding internal hourly rate detail, timekeeper-level hour allocations,