Contract analysis

1. Indemnification Provisions (Article IX / Exhibit D) The indemnification provisions have been significantly revised in this Second Draft, reflecting the most extensively negotiated section of the agreement. The revisions incorporate the structural framework set forth in the indemnification term sheet proposed by Penterra on May 5, 2023, which was the product of considerable internal analysis by Penterra's clinical

2. Insurance Requirements (Exhibit E) The insurance provisions in Exhibit E have been revised to reflect Penterra's position regarding appropriate coverage levels for the CLARION trial. Sponsor Insurance. Penterra will maintain clinical trial liability insurance with per-occurrence limits of Twenty-Five Million Dollars ($25,000,000) and aggregate limits of Seventy-Five Million Dollars ($75,000,000), underwritten by B

3. Budget and Payment Schedule (Exhibit B) The budget and payment provisions in Exhibit B have been revised to reflect the agreed framework for compensation of Veridian and the participating site institutions. The revised structure moves away from the front-loaded payment approach initially proposed in Veridian's markup and toward a milestone-based model that Penterra believes appropriately aligns payment disbursemen

4. Publication Rights (Exhibit G) The publication rights provisions have been revised in an effort to balance Veridian's emphasis on investigator academic freedom with Penterra's legitimate interest in protecting confidential information and patentable subject matter arising from the CLARION trial. Under the revised Exhibit G, investigators retain the right to publish or present the results of the study, subject to P

5. Data Ownership and intellectual Property (Exhibits F and G) The data ownership and intellectual property provisions have been revised as follows: Data Ownership. Penterra retains exclusive ownership of all clinical trial data generated in the conduct of the CLARION trial, including but not limited to case report form data, source data, bioanalytical data, pharmacokinetic and pharmacodynamic data, safety data, effi

6. Regulatory Compliance (Exhibit H) The regulatory compliance provisions in Exhibit H have been updated to reflect both parties' representations, warranties, and ongoing covenants regarding compliance with the following regulatory requirements: • 21 C.F.R. Part 11 (Electronic Records; Electronic Signatures); • 21 C.F.R. Part 50 (Protection of Human Subjects); • 21 C.F.R. Part 54 (Financial Disclosure by Clinical Inv

7. Safety Reporting (Exhibit J) The safety reporting provisions in Exhibit J have been confirmed and refined in the Second Draft as follows: Site-Level SAE Reporting. Each participating site is required to report all serious adverse events ("SAEs") to both Penterra and Meridian Contract Research Organization, Inc. ("Meridian CRO") within twenty-four (24) hours of the site's awareness of the event, using the electroni

8. Termination and Wind-Down (Article XII) The termination and wind-down provisions have been revised to provide for a wind-down period of one hundred twenty (120) calendar days following the effective date of termination, during which time the parties will cooperate to ensure the orderly transition or completion of treatment for all enrolled subjects. Subjects in active treatment at the time of termination must be e

9. Dispute Resolution (Article XIV) The dispute resolution provisions have been revised to reflect a three-step escalation framework, as follows: Step 1 — Designated Representative Negotiation. In the event of any dispute, controversy, or claim arising out of or relating to the MCTA, the parties shall first attempt to resolve the matter through good-faith negotiations between their designated representatives for a pe

10. Miscellaneous Revisions The Second Draft includes a number of additional conforming and clarifying edits, including the following: • Minor conforming edits throughout the MCTA and its exhibits to reflect Veridian's status as a 501(c)(3) tax-exempt organization (EIN: 23-4178205), including adjustments to representations regarding tax status, the inapplicability of certain withholding provisions, and the treatment

1. Insurance Coverage Levels. The final insurance coverage levels remain open. Penterra's position, as reflected in the Second Draft, is $25,000,000 per occurrence / $75,000,000 aggregate. Veridian's initial markup demanded $50,000,000 per occurrence. Penterra believes its proposed levels are appropriate and consistent with industry standards, as discussed above, but recognizes that this issue requires further dialog

2. Protocol-Deviation Liability Allocation. The distinction between medically necessary protocol deviations (i.e., deviations undertaken to protect the immediate safety of a study subject) and unauthorized deviations (i.e., deviations made without Penterra's prior written authorization and not required for subject safety) requires further clarification, particularly as it relates to the allocation of liability and th

3. Publication Rights. The specific language governing Penterra's sixty (60)-day review period and the additional ninety (90)-day patent delay remains in brackets. We anticipate that additional discussion will be needed to finalize the mechanics of the review and delay process, including the dispute resolution mechanism for disagreements regarding the removal of confidential or patentable information.

4. Termination Wind-Down Payment Obligations. The treatment of payment obligations during the one hundred twenty (120)-day wind-down period, including milestone payments for subjects in active treatment, requires further discussion and agreement.

5. Investigator Independence Language. Certain provisions regarding investigator independence in the conduct of the clinical trial, including the scope of the principal investigator's authority to make medical decisions independent of Sponsor direction, remain in brackets pending further negotiation. We invite discussion on each of these points at your and your client's earliest convenience. We would welcome the oppo