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Contract analysis / dormancy-confirmation-letter.docx
dormancy-confirmation-letter.docx
1018-00005 · 12 clauses
High · 0 Medium · 2 Standard · 4
1. Cessation of Work Standard
⚑ Commercial term
1. Cessation of Work All work on Matter No. 1018-00005 has ceased as of December 1, 2022. No further billable activity will be undertaken by any member of the engagement team on the draft United States Prescribing Information ("USPI"), the Medication Guide, the Risk Evaluation and Mitigation Strategy ("REMS") assessment section, or any other sNDA-related work product unless and until Penterra Pharmaceuticals Corp. ("
2. File Preservation Medium
⚑ Liability cap to check against exposure
2. File Preservation All work product, correspondence, memoranda, and files generated during the active phase of the engagement — spanning from July 7 through November 30, 2022 — have been preserved in both physical and electronic form. These files will be maintained in accordance with Calderwood & Harkness's standard document retention policies as well as any specific instructions provided by Penterra. The engagemen
3. Financial Reconciliation Standard
⚑ Commercial term
3. Financial Reconciliation We are pleased to confirm that all financial obligations arising from the active period of the engagement have been fully satisfied. There are no outstanding balances, unbilled amounts, or unresolved disbursements. A summary of the financial reconciliation for the engagement through the date of dormancy is set forth below: For reference, the billing rates in effect during the active period
4. Reactivation Procedures
4. Reactivation Procedures When Penterra wishes to reactivate the engagement, we ask that the Company provide written notice to the undersigned or to Joel Strauss, the responsible partner on the matter. We understand that Penterra currently anticipates that reactivation may occur upon the availability of top-line data from the redesigned CLARION-3R study, which is projected for the second half of 2024. We recognize,
1. Staffing Confirmation. Joel Strauss, the responsible partner on this matter, will conf
1. Staffing Confirmation. Joel Strauss, the responsible partner on this matter, will confirm the availability of the engagement team and identify any necessary adjustments to the staffing plan. The team as constituted during the active phase comprised: Joel Strauss (responsible partner), Miriam Calloway (billing partner), Sean Morrissey (lead associate), and Christopher Aiken (working associate). In the event that an
2. Conflicts Check. A full conflicts review will be re-run in accordance with Firm policy
2. Conflicts Check. A full conflicts review will be re-run in accordance with Firm policy to ensure that no new conflicts of interest have arisen during the dormancy period that would affect our ability to represent Penterra on this matter. We will promptly notify Penterra of the results of this review and, in the unlikely event a conflict is identified, work with the Company to determine whether appropriate waivers
3. Rate Confirmation. Any adjustments to the Firm's billing rates that have taken effect
3. Rate Confirmation. Any adjustments to the Firm's billing rates that have taken effect during the dormancy period will be communicated to Penterra and confirmed in writing before work resumes. If the scope of services has materially changed — for example, due to new clinical data, changes in the regulatory pathway, or the addition of new deliverables — updated engagement terms will be documented in an amendment to
4. Regulatory-Landscape Update Memorandum. Upon reactivation, the engagement team will pr Standard
⚑ Commercial term
4. Regulatory-Landscape Update Memorandum. Upon reactivation, the engagement team will prepare a comprehensive status memorandum for Penterra identifying all material regulatory developments that occurred during the dormancy period. This memorandum will address, at a minimum, the following areas: (a) FDA guidance documents affecting Janus kinase ("JAK") inhibitors, including any updates to the boxed warning framework
5. Work-Product Review. All preserved drafts — including the USPI Rev. 3, the Medication Medium
⚑ Notice / time limit to track
5. Work-Product Review. All preserved drafts — including the USPI Rev. 3, the Medication Guide Rev. 2, and the REMS assessment analysis — will be retrieved from the engagement file and reviewed in detail by the engagement team. The team will assess each deliverable for necessary updates in light of the CLARION-3R data, any intervening regulatory changes identified in the regulatory-landscape update memorandum, and an
5. Continued Availability During Dormancy
5. Continued Availability During Dormancy Although the matter is dormant and no active billable work will be performed, Joel Strauss and the Healthcare & Life Sciences team at Calderwood & Harkness remain available to respond to discrete questions or provide limited guidance that may arise during the interim period. We recognize that the regulatory and competitive landscape for JAK inhibitors in psoriasis continues t
6. Annual Dormancy Review
6. Annual Dormancy Review Pursuant to Calderwood & Harkness's firm policy, dormant matters are subject to annual review to ensure that the Firm's records remain current and that client expectations regarding the status of inactive matters are regularly confirmed. This matter will be reviewed on or before December 1, 2023, and annually thereafter for so long as it remains in dormant status. If the Firm does not hear f
7. Scope Limitation Standard
⚑ Commercial term
7. Scope Limitation For the avoidance of doubt, the dormancy confirmed in this letter relates solely to the chronic plaque psoriasis sNDA labeling supplement engagement under Matter No. 1018-00005. It does not affect, modify, or otherwise alter the terms of any other engagement, if any, between Penterra Pharmaceuticals Corp. (or any of its affiliates or subsidiaries) and Calderwood & Harkness LLP. On behalf of the en