PRIVILEGED & CONFIDENTIAL — ATTORNEY-CLIENT COMMUNICATION
Dear Joel and Miriam,
Thank you for the thorough post-CLARION-3 regulatory path analysis memorandum dated November 28, 2022. We have discussed the options you outlined with Dr. Anand Raghavan and the senior leadership team, and Penterra has decided to proceed consistent with the recommendation set forth in Section IV of that memorandum — namely, to place the sNDA labeling supplement effort on formal hold while we pursue a redesigned confirmatory trial (CLARION-3R).
To that end, I would ask that you observe the following directives:
**1. Cessation of Work.** Please treat the engagement under Matter No. 1018-00005 as **dormant** effective today, December 1, 2022. No further work should be performed on the draft USPI, Medication Guide, REMS assessment, or any other sNDA-related work product until Penterra instructs otherwise.
**2. Preservation of Work Product.** Please retain all drafts, memoranda, correspondence, and working files in their current state. We anticipate reactivating this matter when CLARION-3R top-line data become available. Our current projection for CLARION-3R top-line data is the second half of 2024.
**3. Billing Confirmation.** We confirm that all invoices through November 30, 2022 — totaling $287,450 in fees — have been paid in full. No further invoices should be submitted during the dormancy period unless Penterra requests specific services.
**4. Reactivation.** Penterra will provide written notice when it wishes to reactivate the engagement. We expect to reach out well in advance of the CLARION-3R data readout to allow sufficient time for the team to ramp up.
**5. Scope Clarification.** For the avoidance of doubt, this dormancy relates solely to the psoriasis sNDA labeling supplement (Matter No. 1018-00005). It does not affect any other engagement between Penterra and Calderwood & Harkness, if any.
I want to express our sincere appreciation for the excellent work the Calderwood & Harkness team has done on this matter to date. The regulatory strategy memoranda and draft labeling you have prepared will be invaluable when work resumes. Please do not hesitate to reach out if you have any questions.
Best regards,
Lisa Moritani General Counsel & Corporate Secretary Penterra Pharmaceuticals Corp. 900 Commons Way, Suite 400 Dralvecen, NJ 08807 T: (908) 442-3100 lmoritani@penterra.com
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