Contract analysis

I. Purpose This memorandum formally opens Matter No. 1018-00004 in the firm's matter management system and establishes the foundational record for the engagement described herein. Its purpose is to document the key facts, parties, transaction parameters, legal issues, engagement team composition, and anticipated timeline relevant to the matter so that all team members and firm administrative personnel have a consolid

II. Client Information The following information summarizes the key facts regarding the client for purposes of this engagement. Full Legal Name: Penterra Pharmaceuticals Corp. Short Names / Abbreviations Used in this Memorandum and Related Correspondence: Penterra; PPC. Entity Type: Corporation, incorporated under the laws of the State of Delaware. Penterra was originally incorporated in Delaware in 2009 and has main

1. Nathaniel Briggs, Esq. — Vice President & General Counsel. Mr. Briggs exercises overall legal oversight over the MCTA negotiation and serves as an authorized signatory for Penterra on the executed agreement. Communications with Mr. Briggs should generally be routed through Ms. Liang unless the matter warrants direct escalation. Mr. Briggs's office is located at Penterra's Princeton headquarters.

2. Rebecca Liang, Esq. — Associate General Counsel, Clinical Affairs. Ms. Liang is the day-to-day legal contact for all matters relating to the MCTA negotiation and drafting. She will serve as the principal liaison between Penterra's in-house legal team and Calderwood & Harkness on all aspects of this engagement. Ms. Liang has extensive experience in clinical trial agreements and has worked with Veridian on prior tra

3. Samantha Novak — Director, Clinical Contracts. Ms. Novak oversees contracts administration within Penterra's clinical operations function and will be responsible for the operational aspects of MCTA implementation, including site-level joinder agreements, budget negotiations at the site level, and coordination with Penterra's contract research organization. Ms. Novak's involvement will become more significant durin

III. Counterparty Information The following information summarizes the key facts regarding the counterparty to the MCTA. Full Legal Name: Veridian Health Research Network, Inc. Short Names / Abbreviations Used in this Memorandum and Related Correspondence: Veridian; VHRN. Entity Type: Corporation, incorporated under the laws of the State of Delaware. Veridian is organized and operates as a tax-exempt organization und

1. Dr. Franklin Osei, M.D., Ph.D. — President & Chief Executive Officer. Dr. Osei serves as the executive counterpart to Dr. Raghavan and is an authorized signatory for Veridian on the MCTA. Dr. Osei may participate in high-level discussions regarding the strategic framework of the agreement but is not expected to be involved in day-to-day negotiations.

2. Diane Prescott — Chief Operating Officer. Ms. Prescott is the operational counterpart to Jennifer Holt at Penterra and will likely be involved in discussions regarding operational provisions, site activation timelines, and network coordination logistics.

3. Dr. Lena Marchetti, Ph.D. — Senior Vice President, Research Administration. Dr. Marchetti oversees Veridian's research administration function and is responsible for budgetary and administrative matters relating to sponsored research agreements across the network.

4. Gregory Callahan, Esq. — Vice President, Legal & Compliance. Mr. Callahan is the legal lead for Veridian on the MCTA negotiation. He is expected to manage the legal review process on Veridian's side and to serve as the primary point of contact for counterpart communications with Calderwood & Harkness and with Veridian's outside counsel. (Note: Mr. Callahan shares a surname with the undersigned but there is no fami

5. Patricia Dunne — Director, Sponsored Research Agreements. Ms. Dunne will handle the contracts negotiation at a working level on Veridian's side and will be the primary counterpart for Samantha Novak of Penterra on site-level budget and payment issues. Counterparty Outside Counsel Veridian has retained Whitmore, Jansen & Callahan LLP ("WJC") as its outside counsel for the MCTA negotiation. WJC's relevant personnel

IV. Matter Description A. Nature of the Matter This matter involves the negotiation, drafting, and closing of a clinical trial agreement. Specifically, the engagement encompasses the preparation and negotiation of a Master Clinical Trial Agreement ("MCTA") and associated site-network agreements between Penterra Pharmaceuticals Corp. (as Sponsor) and Veridian Health Research Network, Inc. (as Site Network) for the con

1. Meridian Contract Research Organization, Inc. ("Meridian CRO"). Meridian is Penterra's contracted CRO for the CLARION trial, responsible for clinical monitoring, data management, safety reporting, and biostatistics. Meridian is headquartered at 9200 Corporate Boulevard, Raleigh, North Carolina 27615, and is led by CEO Thomas Hartwell. Penterra and Meridian are parties to a separate Master Services Agreement dated

2. Briarcliff Mutual Insurance Company. Briarcliff is Penterra's clinical trial liability and subject-injury insurer. Briarcliff is located at 55 Constitution Plaza, Hartford, Connecticut 06103. The relevant policy information is as follows: • Policy Number: BM-CTL-2023-04182 • Policy Period: April 1, 2023 through March 31, 2024 (renewable annually) • Per-Occurrence Limit: $25,000,000 • Aggregate Limit: $75,000,000 •

3. Pinnacle Data Solutions, Inc. Pinnacle is Penterra's electronic data capture (EDC) and eClinical platform vendor for the CLARION trial. Pinnacle is located at 6000 Clearwater Drive, San Diego, California 92121. The MCTA will reference Pinnacle's EDC platform in connection with data entry, electronic signatures (21 C.F.R. Part 11 compliance), and the technology integration costs included in the deal value.

4. Northbridge Bioanalytical Laboratories, Inc. Northbridge serves as the central laboratory for the CLARION trial, responsible for pharmacokinetic/pharmacodynamic (PK/PD) analyses, biomarker assessments, and safety laboratory analyses. Northbridge is located at 2900 Commerce Way, Baltimore, Maryland 21224. The MCTA will address specimen handling, shipping, chain of custody, and the responsibilities of participating

5. Castleton & Hargrove LLP. Castleton & Hargrove serves as FDA regulatory counsel to Penterra and is responsible for all regulatory strategy matters relating to the penterafenib program, including IND maintenance, FDA communications, and regulatory submissions. Castleton & Hargrove is located at 1100 Connecticut Avenue NW, Suite 900, Washington, DC 20036. The lead partner for the Penterra engagement is Dr. Priya Sun

V. Governing Law The MCTA is expected to be governed by the laws of the State of New York, without regard to its conflicts of law principles. This choice of law is consistent with Penterra's standard contractual practice for clinical trial agreements and reflects the firm's location in New York as well as the well-developed body of New York commercial contract law that provides a predictable framework for interpretin

1. Designated Representative Negotiation (30 days). In the first instance, any dispute will be referred to designated senior representatives of each party (anticipated to be individuals at the Vice President level or above) for good-faith negotiation and attempted resolution. The designated representatives will have a period of thirty (30) days from the date of referral to resolve the dispute through direct negotiati

2. Mediation (60 days). If the dispute is not resolved through designated representative negotiation within the initial 30-day period, either party may refer the dispute to mediation administered by the American Arbitration Association ("AAA") under the AAA Commercial Mediation Rules then in effect. The mediation will be conducted in New York, New York, and the parties will have a period of sixty (60) days from the c

3. Binding Arbitration. If the dispute is not resolved through mediation within the 60-day period, either party may submit the dispute to binding arbitration in New York, New York, administered by the AAA under the AAA Commercial Arbitration Rules then in effect. The arbitration will be conducted before a panel of three (3) arbitrators, with each party selecting one arbitrator and the two party-selected arbitrators s

VI. Key Legal Issues Anticipated Based on the engagement team's initial review of the matter and its experience with comparable clinical trial agreements, the following legal issues are anticipated to be significant in the negotiation of the MCTA. This list is not exhaustive and will be updated as the negotiation progresses.

1. Subject-Injury Indemnification Scope and Caps. The scope and financial limits of the Sponsor's indemnification obligations for injuries suffered by clinical trial subjects will be a central issue in the MCTA negotiation. Veridian and its network sites will seek broad indemnification from Penterra for subject injuries arising from the investigational product, while Penterra will seek to limit its indemnification ex

2. Allocation of Liability for Protocol Deviations. The MCTA will need to clearly allocate liability between Penterra and Veridian (and its network sites) for protocol deviations, with particular attention to the distinction between medically necessary deviations (e.g., deviations undertaken for subject safety) and unauthorized deviations (e.g., deviations resulting from investigator error or negligence). The treatme

3. Insurance Adequacy. Veridian may demand higher per-occurrence limits than those provided under the current Briarcliff policy (which provides $25 million per occurrence and $75 million in the aggregate). Academic medical centers and research networks commonly require per-occurrence limits of $50 million or more for Phase III oncology trials with large enrollment targets. The engagement team should confer with the c

4. Data Ownership and intellectual Property Rights. Penterra will seek to retain exclusive ownership of all clinical trial data generated in connection with the CLARION trial, consistent with its position as the IND holder and regulatory sponsor. This position is standard in the pharmaceutical industry but may be resisted by Veridian and its academic investigators, who may seek co-ownership, access, or use rights wit

5. Investigator Publication Rights and Academic Freedom vs. Sponsor Review/Patent Protection. The tension between investigators' academic freedom and desire to publish clinical trial results, on the one hand, and the sponsor's interest in reviewing proposed publications for accuracy, patent protection, and confidentiality, on the other hand, is a recurring issue in clinical trial agreements with academic institutions

6. Termination Provisions and Wind-Down Period for Subject Safety. The MCTA must contain robust termination provisions that address both for-cause and without-cause termination, as well as termination due to safety concerns, regulatory action, or force majeure events. Of particular importance are the wind-down provisions that will apply following termination, including obligations to continue treating enrolled subjec

7. Regulatory Compliance Frameworks. The MCTA must address compliance with a number of federal and state regulatory frameworks, including but not limited to: • The Federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)) and the safe harbor regulations thereunder, with particular attention to the fair market value of all payments to investigators and sites; • The Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h)

8. Fair Market Value of Investigator Compensation and Site Payments. As noted above, all payments to investigators and sites under the MCTA must be established at fair market value to mitigate risk under the Anti-Kickback Statute. The engagement team should coordinate with Penterra to obtain or commission a fair market value assessment of all payment components, including per-patient fees, start-up fees, maintenance

9. IRB Oversight Structure. The MCTA negotiation will need to address the IRB oversight structure for the CLARION trial, including the use of the Graystone University Institutional Review Board and the Veridian Central IRB. The parties will need to determine whether the trial will use a single central IRB for all participating sites (with individual sites entering into IRB reliance agreements) or whether some sites w

10. Confidentiality. The MCTA is expected to include a confidentiality provision with a term of ten (10) years, which is standard for clinical trial agreements in the pharmaceutical industry. The confidentiality provisions will need to address the definition of confidential information, permitted disclosures (including disclosures required by law, regulation, or court order, and disclosures in connection with regulat

11. Safety Reporting Procedures. The MCTA will establish the safety reporting obligations of the parties, including: (a) reporting of serious adverse events (SAEs) by investigators to the sponsor within 24 hours of awareness; (b) the sponsor's obligations with respect to IND safety reports to the FDA on 7-day timelines (for fatal or life-threatening unexpected suspected adverse reactions) and 15-day timelines (for ot

12. Site Document Retention. The MCTA will establish document retention requirements for participating sites. The current expectation is that sites will be required to retain all study-related documents for a minimum of fifteen (15) years following the completion of the study. This retention period exceeds the FDA's minimum requirements under 21 C.F.R. § 312.62 and is consistent with Penterra's standard contractual p

VII. Engagement Team The following attorneys and professional staff of Calderwood & Harkness LLP are assigned to this engagement. Responsible Partner: Miriam Calloway, Partner, Healthcare & Life Sciences Practice Group. Ms. Calloway will serve as the Responsible Partner for the engagement, with overall responsibility for the quality and timeliness of all work product, the management of the client relationship, and th

VIII. Projected Timeline and Key Milestones The following timeline sets forth the key milestones and target dates for the engagement. These dates are based on the client's stated objective of achieving a target first-patient-in (FPI) date of August 14, 2023, and reflect the engagement team's assessment of a realistic but aggressive schedule for the negotiation and closing of the MCTA. The engagement team notes that t

IX. Scope of Representation The scope of Calderwood & Harkness's representation of Penterra in this matter encompasses the following work streams and deliverables:

1. Master Clinical Trial Agreement. Drafting and negotiation of the Master Clinical Trial Agreement between Penterra (as Sponsor) and Veridian (as Site Network), including all substantive terms and conditions governing the conduct of the CLARION trial across the 38 participating Veridian Network sites.

2. MCTA Exhibits and Schedules. Drafting of all exhibits and schedules to the MCTA, which are anticipated to include the following: (a) Protocol Synopsis (Exhibit A); (b) Budget and Payment Schedule (Exhibit B); (c) Site Joinder Form (Exhibit C); (d) Subject-Injury Indemnification Provisions (Exhibit D); (e) Insurance Requirements (Exhibit E); (f) Confidentiality and Data Protection Provisions (Exhibit F); (g) intell

3. Site Joinder Agreements. Preparation of individual site agreements (joinder agreements) for each of the 38 Veridian Network sites, incorporating the terms of the MCTA by reference and containing site-specific information including local budgets, investigator designations, and local regulatory approvals.

4. Principal Investigator and Co-Principal Investigator Agreements. Preparation of investigator-level agreements for Dr. Catherine Aldridge (Global Principal Investigator) and Dr. Howard Matsuoka (Co-Principal Investigator at Lakemont Medical Center), as well as template investigator agreements for use at other participating sites. 5. intellectual Property Side Letter. Negotiation and execution of an intellectual pro

6. Closing Deliverables. Preparation of all closing deliverables required for the MCTA closing, including closing certificates, secretary's certificates (certifying organizational authority), officer's certificates (certifying representations and warranties), and any other instruments required to satisfy the conditions precedent to the effectiveness of the MCTA.

7. Insurance Coordination. Coordination with Penterra's insurance broker and with Briarcliff Mutual Insurance Company regarding additional insured endorsement requests, certificate of insurance exchanges, and any policy amendments or supplemental coverage that may be required to satisfy Veridian's insurance requirements under the MCTA.

8. Regulatory Compliance Analysis Memoranda. Preparation of one or more legal memoranda analyzing the regulatory compliance implications of the MCTA and the CLARION trial, including analysis under the Anti-Kickback Statute, the Physician Payments Sunshine Act / Open Payments, HIPAA (45 C.F.R. Parts 160 and 164), and the FDA financial disclosure requirements under 21 C.F.R. Part 54.

9. Fair Market Value Analysis. Preparation or coordination of a fair market value analysis for investigator compensation and site payment amounts under the MCTA, to support compliance with the Anti-Kickback Statute and applicable safe harbor provisions.

10. IRB Reliance / Central IRB Structure Analysis. Analysis of the available IRB oversight models for the CLARION trial, including the use of the Graystone University IRB, the Veridian Central IRB, and individual site IRBs, and preparation of recommendations regarding the optimal IRB oversight structure. Matters Not in Scope The following matters are expressly excluded from the scope of this engagement and are being

X. Administrative Information The following administrative information is recorded for the purpose of matter management and firm operations. Document Management: All documents generated or received in connection with this matter are to be filed under Matter No. 1018-00004 in the firm's document management system. Team members should follow the firm's standard document naming conventions and filing protocols. All priv

XI. Distribution This memorandum is designated for internal distribution only within Calderwood & Harkness LLP. It is not to be provided to the client, counterparty, or any third party without the prior written authorization of the Responsible Partner. Internal Distribution: • Miriam Calloway, Partner • Joel Strauss, Partner • Sean Morrissey, Associate • Christopher Aiken, Associate Copy to File: Matter No. 1018-0000