Dear Rebecca,
Thank you for engaging Calderwood & Harkness on this matter. We are pleased to confirm that the signed engagement letter and retainer acknowledgment are being processed today and that the firm has been formally retained to represent Penterra Pharmaceuticals Corp. in the negotiation, drafting, and finalization of the Master Clinical Trial Agreement ("MCTA") and associated site-network agreements with Veridian Health Research Network, Inc. for Penterra's Phase III clinical trial of penterafenib (PPC-4871) under Protocol PPC-4871-III — the CLARION trial (Clinical Assessment of Response with Longitudinal Investigation in ONcology). This matter has been assigned Matter No. 1018-00004.
As you know, the total anticipated deal value is approximately $80,000,000, covering site fees, per-patient payments, investigator grants, and operational costs across the projected 42-month enrollment period. Given the scope and significance of this engagement, I wanted to provide you with a comprehensive overview of our team, our preliminary work plan, and our initial document requests so that we can hit the ground running.
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**1. ENGAGEMENT TEAM**
We have assembled a dedicated team for this matter:
- **Miriam Calloway** (Partner, Healthcare & Life Sciences Practice Group) — I will serve as the Responsible Partner and primary relationship partner and will lead negotiations directly with Veridian and its counsel.
- **Joel Strauss** (Partner, Healthcare & Life Sciences Practice Group) — Joel will serve as Billing Partner and will oversee all billing and budgetary matters for the engagement. He is copied on this email.
- **Sean Morrissey** (Senior Associate, Healthcare & Life Sciences Practice Group) — Sean will serve as Lead Associate and will handle day-to-day drafting, markup analysis, and negotiation support. He will be the primary working-level contact for you and your team. Sean can be reached directly at (212) 556-7283 or smorrissey@calderwoodharkness.com.
- **Christopher Aiken** (Associate, Healthcare & Life Sciences Practice Group) — Christopher will support research, due diligence, regulatory compliance analysis, and drafting of ancillary documents and exhibits.
One additional note: for any FDA regulatory questions that intersect with the MCTA — IND maintenance, clinical hold considerations, and the like — our team may need to coordinate with Castleton & Hargrove LLP (Dr. Priya Sundaram), whom I understand serves as Penterra's regulatory counsel. Could you please confirm whether that coordination is appropriate and, if so, whether there are any protocols you would like us to follow for those communications?
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**2. PRELIMINARY WORK PLAN — PHASED APPROACH**
We anticipate the engagement proceeding in three phases, as outlined below. These timelines are preliminary and subject to adjustment based on counterparty responsiveness and client priorities.
**Phase 1: Information Gathering & Initial Drafting (Weeks 1–3, approx. March 20 – April 7)**
- Review all background materials, including the protocol, Veridian term sheet, insurance policy, and the existing Meridian CRO master services agreement for reference. - Conduct preliminary legal analysis of key issues, including: subject-injury indemnification scope, insurance adequacy, IP and data ownership, publication rights, and regulatory compliance considerations (Anti-Kickback Statute, Sunshine Act/Open Payments, HIPAA, and 21 CFR Part 54 financial disclosures), as well as governing law considerations under New York law. - Prepare and circulate to you a Preliminary Issues Memorandum identifying key negotiation points and recommended positions. - Prepare and circulate the first draft of the MCTA to Veridian's outside counsel, Whitmore, Jansen & Callahan LLP (lead partner: Allison Whitmore). Target circulation date: on or about April 7, 2023.
**Phase 2: Negotiation (Weeks 4–12, approx. April – June)**
- Review and analyze Veridian/WJC markups of the initial draft. - Prepare negotiation strategy memoranda for Penterra's review in advance of each substantive negotiation session. - Conduct iterative drafting rounds and, as needed, in-person or virtual negotiation sessions with Veridian's team — specifically Gregory Callahan (VP, Legal & Compliance) and Patricia Dunne (Director, Sponsored Research Agreements) — and WJC. - Separately negotiate and draft all ancillary documents: individual site agreement (joinder) template, investigator agreements, IP side letter, safety reporting procedures, insurance certificate exchanges, and all MCTA exhibits and schedules.
**Phase 3: Execution & Closing (Weeks 13–16, target late June – mid-July)**
- Finalize execution versions of the MCTA and all ancillary documents. - Coordinate signature pages from Penterra (Nathaniel Briggs as authorized signatory), Veridian (Dr. Franklin Osei), and lead site institution Graystone University Medical Center (Dr. William Corwin). - Prepare and deliver closing deliverables: closing certificates, secretary's certificates, officer's certificates, and insurance certificates. - Satisfy conditions precedent, including: delivery of insurance certificates, IRB approvals for lead sites (Graystone University Institutional Review Board, IRB00012847, and Veridian Central IRB for non-Pennsylvania sites), and executed investigator signature pages. - Assemble the closing binder and confirm the effective date.
I would note that we understand the target for first patient in (FPI) is August 14, 2023. We will work backward from that date at every stage to ensure adequate lead time and to flag any scheduling concerns promptly.
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**3. KEY COUNTERPARTY AND STAKEHOLDER INFORMATION**
For our records and to ensure alignment, I want to confirm our understanding of the key counterparties and stakeholders:
- **Veridian Health Research Network, Inc.** — A Delaware 501(c)(3) corporation headquartered at 750 Research Parkway, 8th Floor, Philadelphia, PA 19104, operating 38 academic medical centers and affiliated research sites across 14 states. - **Veridian Outside Counsel** — Whitmore, Jansen & Callahan LLP, 1500 Market Street, Suite 3200, Philadelphia, PA 19102; Allison Whitmore (lead partner) and David Kesselman (associate). - **Global Principal Investigator** — Dr. Catherine Aldridge, Graystone University Medical Center. - **Co-Principal Investigator** — Dr. Howard Matsuoka, Lakemont Medical Center, 4400 North Michigan Drive, Chicago, IL 60611.
A few questions on the Penterra side:
- Can you confirm whether **Samantha Novak** (Director, Clinical Contracts) will serve as the primary contracts-administration contact on the Penterra side? - Should **Jennifer Holt** (VP, Clinical Operations) be included on operational and timeline-related correspondence? - Will **Dr. Marcus Yun** (SVP, Clinical Development) or **Dr. Elaine Whitford** (CMO) need to be consulted on any clinical or protocol-related provisions in the MCTA? If so, we would appreciate knowing the best way to route those questions.
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**4. TRIAL PARAMETERS FOR REFERENCE**
For the team's reference, and to ensure accurate incorporation into the MCTA and its exhibits, we have noted the following key trial parameters:
- **Investigational Product:** Penterafenib (PPC-4871), oral multi-kinase inhibitor - **Indication:** Advanced hepatocellular carcinoma (HCC), second-line after prior systemic therapy - **Design:** Phase III, randomized, double-blind, placebo-controlled - **Planned Enrollment:** 1,200 subjects (2:1 randomization — 800 treatment : 400 placebo) - **Primary Endpoint:** Overall survival (OS) - **Key Secondary Endpoints:** Progression-free survival (PFS), objective response rate (ORR), duration of response (DOR) - **Sites:** 38 Veridian network sites across 14 states - **Enrollment Period:** 42 months; total study duration: 60 months - **ClinicalTrials.gov Identifier:** NCT05928174 - **IND Number:** IND 157823
Please let us know if any of the above requires correction or updating.
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**5. DOCUMENT REQUESTS**
To enable us to begin Phase 1 work promptly, we would appreciate receiving the following materials at your earliest convenience:
1. **Draft Protocol** — Current version of Protocol PPC-4871-III (CLARION), including the protocol synopsis, if available in near-final or final form.
2. **Veridian Term Sheet or Preliminary Agreement** — Any term sheet, letter of intent, or preliminary understanding exchanged between Penterra and Veridian regarding the MCTA structure, budget, or key terms.
3. **Briarcliff Insurance Policy** — Copy of Penterra's clinical trial liability insurance policy with Briarcliff Mutual Insurance Company (Policy No. BM-CTL-2023-04182, policy period April 1, 2023 – March 31, 2024), including the declarations page, all endorsements, and any subject-injury sublimit provisions. We understand the per-occurrence limit is $25,000,000 and the aggregate is $75,000,000, with a subject-injury sublimit of $10,000,000 per occurrence / $50,000,000 aggregate — we will need to confirm these figures against the policy and assess their adequacy in light of the trial's scope and Veridian's expected requirements.
4. **Meridian CRO Master Services Agreement** — Copy of the MSA with Meridian Contract Research Organization, Inc. dated January 15, 2023, for reference on the scope of CRO responsibilities and any provisions that may need to dovetail with the MCTA (e.g., safety reporting coordination, data management, monitoring).
5. **Veridian Template Agreements** — Any form agreements Veridian has provided or typically uses for sponsored research and clinical trial arrangements.
6. **Budget Detail** — Internal budget breakdown for CLARION trial site costs, including per-patient fee calculations ($52,000/subject), start-up fees ($75,000/site), site maintenance fees ($40,000/site/year), network coordination fees ($300,000/quarter), investigator grants ($1,500,000), and technology/EDC integration costs ($1,230,000 for the Pinnacle Data Solutions platform).
7. **Investigator CVs and Financial Disclosures** — CVs for Dr. Catherine Aldridge and Dr. Howard Matsuoka, and any preliminary 21 CFR Part 54 financial disclosure information available at this time.
8. **IRB Information** — Current status of IRB submissions or pre-submissions at Graystone (IRB00012847) and information regarding the Veridian Central IRB structure for non-Pennsylvania sites.
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**6. CONFLICT CHECK CONFIRMATION**
The firm has completed its conflicts check against Veridian Health Research Network, Inc., Graystone University Medical Center, Lakemont Medical Center, Whitmore, Jansen & Callahan LLP, and all other relevant parties. The matter has been cleared with no conflicts identified. Christopher Aiken has documented the check in a separate memorandum, which is on file.
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**7. PROPOSED NEXT STEPS**
I would like to propose a kick-off call later this week — either **Wednesday, March 22** or **Thursday, March 23** — with you, Nathaniel, Samantha Novak, and Jennifer Holt (if appropriate) to discuss priorities, timeline, and any preliminary views Penterra may have on key negotiation positions. In particular, I think an early discussion of the indemnification structure and insurance thresholds would be valuable, as these tend to be the most heavily negotiated provisions with academic research networks.
As noted above, our target remains to circulate the first draft MCTA to Veridian/WJC by April 7, 2023.
On a personal note, I want to say how enthusiastic our team is about the CLARION program. Reaching this Phase III milestone on the strength of the Phase II results — a 38% ORR in advanced HCC is truly compelling — is a significant achievement for Penterra, and we are honored to support the program at this critical stage. We look forward to helping bring this agreement to execution efficiently and on a timeline that supports the August FPI target.
Please don't hesitate to reach out with any questions in the meantime. Sean and I are both available this week and happy to connect at your convenience.
Warm regards,
**Miriam Calloway** Partner, Healthcare & Life Sciences Practice Group Calderwood & Harkness LLP 280 Park Avenue, 34th Floor New York, NY 10017
101 Carnegie Center, Suite 500 Princeton, NJ 08540
T: (212) 556-7100 D: (212) 556-7142 M: (917) 438-2261 E: mcalloway@calderwoodharkness.com
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