Contract analysis

From: Miriam Calloway <mcalloway@calderwoodharkness.com> To: Allison Whitmore <awhitmore@wjclaw.com> Cc: Sean Morrissey <smorrissey@calderwoodharkness.com> Date: Thu, 01 Jun 2023 10:47:00 -0000 Subject: CLARION Trial MCTA — Proposed In-Person Negotiation Session, June 9

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 shap

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 atte

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-inju

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 carv

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

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, 2

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.

**Miriam Calloway** Partner, Healthcare & Life Sciences Practice Group Calderwood & Harkness LLP 280 Park Avenue, 34th Floor New York, NY 10017 T: (212) 506-4100 | D: (212) 506-4138 E: mcalloway@calderwoodharkness.com

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