Allison,
I hope you're well. I understand from David's note earlier this week that your team is finalizing Veridian's second markup of the MCTA for Protocol PPC-4871-III (CLARION), and we expect to have that in hand shortly. I want to say at the outset that we appreciate the constructive approach both you and Gregory have taken throughout this process — we've made genuinely productive progress over the past two months in shaping the framework for the Penterra–Veridian relationship on this trial. That said, a number of substantive open issues remain, and my sense is that we've reached a point where continued exchange of redlines is likely to be less efficient than getting the principals and key counsel together in one room to work through the remaining gaps.
To that end, I'd like to propose an in-person negotiation session on **Friday, June 9, 2023**. In the interest of convenience for your team, we're happy to come to you — would your Philadelphia office at 1500 Market Street, Suite 3200, work as a venue? I'd suggest we plan for a full-day session, starting at 9:30 AM, with a working lunch so we can maintain momentum. From Penterra's side, Sean Morrissey and I will attend, along with Rebecca Liang (Associate General Counsel, Clinical Affairs). We may also ask Jennifer Holt, Penterra's VP of Clinical Operations, to join if operational questions come up during the discussion. On your side, I'd expect Gregory Callahan and Patricia Dunne would want to be present in addition to WJC counsel, but I'll leave that to you and Gregory to determine.
I envision the session focusing on the three substantive areas that have proven most difficult to bridge through written markups alone:
1. **Insurance Requirements.** Veridian's initial position called for $50,000,000 per-occurrence clinical trial liability coverage. As we've indicated, Penterra's existing policy with Briarcliff Mutual (Policy No. BM-CTL-2023-04182) provides $25,000,000 per occurrence and $75,000,000 in the aggregate, which we believe is well within industry standards for Phase III oncology trials, particularly given the subject-injury sublimit structure. We're prepared to share additional detail on the Briarcliff policy architecture to address Veridian's concerns, and I think a face-to-face discussion will be more productive than further back-and-forth on this point.
2. **Protocol-Deviation Liability Allocation.** We remain apart on allocation of liability for medically necessary protocol deviations. Penterra fully acknowledges that deviations undertaken by investigators in response to an immediate threat to subject safety should remain within the scope of sponsor indemnification. However, other unauthorized deviations present a different risk profile, and we believe a clear carve-out is appropriate. I'd like to work through specific scenarios together so we can agree on language that gives both parties the certainty they need.
3. **Investigator Independence / Publication Rights.** We understand and respect Veridian's strong institutional commitment to academic freedom and investigator publication rights. Penterra's proposed compromise — a 60-day sponsor review period limited to identification of confidential information and patentable subject matter, with an additional 90-day delay available solely to permit patent filings — is, we believe, well within the range of what major research networks have accepted in comparable agreements. I'm confident this is one we can close with focused discussion.
If time permits, there are several smaller drafting points — including the termination wind-down payment obligations — that would also benefit from discussion.
I want to underscore the importance of maintaining our timeline. Given the overall deal value of $80,000,000 and the complexity of coordinating 38 sites across 14 states, prompt finalization of the MCTA is critical. As you know, IRB approvals at the lead sites — Graystone University Medical Center and Lakemont Medical Center — are being processed in parallel, and Penterra is targeting first-patient-in on August 14, 2023. Working backward from that date, we need the MCTA and site joinder agreements fully executed with sufficient lead time to satisfy conditions precedent, including the insurance certificate exchange requirement within 15 business days of execution. If our June 9 session is productive, I'm hopeful the parties could be in a position to circulate a near-final draft the following week.
I'm happy to put together a brief agenda in advance of the meeting if that would be useful. Please let me know whether June 9 and the proposed venue work for your team, or suggest an alternative if the date presents a conflict. Thank you, as always, to you and your colleagues for your continued engagement on this matter — we look forward to getting this across the finish line.
Best regards,
**Miriam Calloway** Partner, Healthcare & Life Sciences Practice Group Calderwood & Harkness LLP 280 Park Avenue, 34th Floor New York, NY 10017 T: (212) 506-4100
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