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Contract analysis / conflict-check-memo.docx
conflict-check-memo.docx
High · 1
Medium · 3
Standard · 1
I. Purpose of Memorandum
Standard
⚑ Commercial term
I. Purpose of Memorandum This memorandum documents the results of the conflict-of-interest check conducted in connection with Calderwood & Harkness LLP's proposed engagement by Penterra Pharmaceuticals Corp. ("Penterra" or "PPC") to represent Penterra in the negotiation, drafting, and closing of a Master Clinical Trial Agreement ("MCTA") and related site-network agreements with Veridian Health Research Network, Inc.
II. Engagement Summary
Medium
⚑ Liability cap to check against exposure
II. Engagement Summary The key parameters of the proposed engagement are summarized below for reference and to provide context for the scope of the conflict check. Client: Penterra Pharmaceuticals Corp., a corporation organized and existing under the laws of the State of Delaware, publicly traded on the Nasdaq Global Select Market under the ticker symbol "PTRA." Penterra is headquartered at 200 Biopharma Boulevard, S
III. Parties and Entities Checked
III. Parties and Entities Checked The conflict check encompassed all parties, affiliated entities, key individuals, counterparty counsel, third-party service providers, and other advisors reasonably identifiable at the time of the check as being involved in or related to the proposed engagement. The parties and entities checked are organized by category below. A. Client and Client Affiliates The following entities an
1. Penterra Pharmaceuticals Corp. ("PPC") — a corporation organized and existing under th
1. Penterra Pharmaceuticals Corp. ("PPC") — a corporation organized and existing under the laws of the State of Delaware; publicly traded on the Nasdaq Global Select Market under the ticker symbol "PTRA"; headquartered at 200 Biopharma Boulevard, Suite 1400, Princeton, New Jersey 08540.
2. Dr. Anand Raghavan, M.D., Ph.D. — Chief Executive Officer, Penterra Pharmaceuticals Co
2. Dr. Anand Raghavan, M.D., Ph.D. — Chief Executive Officer, Penterra Pharmaceuticals Corp.
3. Dr. Elaine Whitford, M.D. — Chief Medical Officer, Penterra Pharmaceuticals Corp.
3. Dr. Elaine Whitford, M.D. — Chief Medical Officer, Penterra Pharmaceuticals Corp.
4. Dr. Marcus Yun, M.D., M.P.H. — Senior Vice President, Clinical Development, Penterra P
4. Dr. Marcus Yun, M.D., M.P.H. — Senior Vice President, Clinical Development, Penterra Pharmaceuticals Corp.
5. Jennifer Holt — Vice President, Clinical Operations, Penterra Pharmaceuticals Corp.
5. Jennifer Holt — Vice President, Clinical Operations, Penterra Pharmaceuticals Corp.
6. Nathaniel Briggs, Esq. — Vice President & General Counsel, Penterra Pharmaceuticals Co
6. Nathaniel Briggs, Esq. — Vice President & General Counsel, Penterra Pharmaceuticals Corp.
7. Rebecca Liang, Esq. — Associate General Counsel, Clinical Affairs, Penterra Pharmaceut
7. Rebecca Liang, Esq. — Associate General Counsel, Clinical Affairs, Penterra Pharmaceuticals Corp.
8. Samantha Novak — Director, Clinical Contracts, Penterra Pharmaceuticals Corp.
8. Samantha Novak — Director, Clinical Contracts, Penterra Pharmaceuticals Corp.
9. Capitol Registered Agents, LLC — Penterra's registered agent in the State of Delaware;
9. Capitol Registered Agents, LLC — Penterra's registered agent in the State of Delaware; address: 1209 Orange Street, Wilmington, Delaware 19801. B. Counterparty and Counterparty Affiliates The following entities and individuals were checked as the counterparty and counterparty-side affiliates:
1. Veridian Health Research Network, Inc. ("VHRN") — a corporation organized and existing
1. Veridian Health Research Network, Inc. ("VHRN") — a corporation organized and existing under the laws of the State of Delaware as a tax-exempt organization under Section 501(c)(3) of the Internal Revenue Code; Employer Identification Number ("EIN"): 23-4178205; headquartered at 750 Research Parkway, 8th Floor, Philadelphia, Pennsylvania 19104. Veridian operates a network of academic medical centers, community hosp
2. Dr. Franklin Osei, M.D., Ph.D. — President & Chief Executive Officer, Veridian Health
2. Dr. Franklin Osei, M.D., Ph.D. — President & Chief Executive Officer, Veridian Health Research Network, Inc.
3. Diane Prescott — Chief Operating Officer, Veridian Health Research Network, Inc.
3. Diane Prescott — Chief Operating Officer, Veridian Health Research Network, Inc.
4. Dr. Lena Marchetti, Ph.D. — Senior Vice President, Research Administration, Veridian H
4. Dr. Lena Marchetti, Ph.D. — Senior Vice President, Research Administration, Veridian Health Research Network, Inc.
5. Gregory Callahan, Esq. — Vice President, Legal & Compliance, Veridian Health Research
5. Gregory Callahan, Esq. — Vice President, Legal & Compliance, Veridian Health Research Network, Inc.
6. Patricia Dunne — Director, Sponsored Research Agreements, Veridian Health Research Net
6. Patricia Dunne — Director, Sponsored Research Agreements, Veridian Health Research Network, Inc. C. Participating Site Institutions (Key Sites) The following key participating site institutions and their affiliated individuals were included in the conflict check. These represent the two lead clinical sites for the CLARION trial, as identified by Penterra's clinical development team at the time of matter opening:
1. Graystone University Medical Center — a nonprofit corporation organized and existing u
1. Graystone University Medical Center — a nonprofit corporation organized and existing under the laws of the Commonwealth of Pennsylvania; principal address: 1200 University Avenue, Philadelphia, Pennsylvania 19104. Graystone is an NCI-designated Comprehensive Cancer Center and a flagship member institution of the Veridian Health Research Network. (a) Dr. William Corwin, M.D. — President, Graystone University Medica
2. Lakemont Medical Center — a nonprofit corporation organized and existing under the law
2. Lakemont Medical Center — a nonprofit corporation organized and existing under the laws of the State of Illinois; principal address: 4400 North Michigan Drive, Chicago, Illinois 60611. Lakemont is a major academic medical center and a member institution of the Veridian Health Research Network. (a) Dr. Howard Matsuoka, M.D. — Associate Professor, Hepatology & Oncology, Lakemont Medical Center; designated as a Co-Pr
1. Whitmore, Jansen & Callahan LLP ("WJC") — a limited liability partnership organized un
1. Whitmore, Jansen & Callahan LLP ("WJC") — a limited liability partnership organized under the laws of the Commonwealth of Pennsylvania; principal office: 1500 Market Street, Suite 3200, Philadelphia, Pennsylvania 19102. (a) Allison Whitmore — Partner, Life Sciences & Research Institutions Group, Whitmore, Jansen & Callahan LLP; lead outside counsel for Veridian in connection with the MCTA negotiation. (b) David Ke
1. Meridian Contract Research Organization, Inc. ("Meridian CRO") — a corporation organiz
1. Meridian Contract Research Organization, Inc. ("Meridian CRO") — a corporation organized and existing under the laws of the State of Delaware; principal address: 9200 Corporate Boulevard, Raleigh, North Carolina 27615; serving as the contract research organization for the CLARION trial. Chief Executive Officer: Thomas Hartwell. Penterra has a separate Master Services Agreement with Meridian CRO, dated January 15,
2. Briarcliff Mutual Insurance Company — a mutual insurance company organized under the l
2. Briarcliff Mutual Insurance Company — a mutual insurance company organized under the laws of the State of Connecticut; principal address: 55 Constitution Plaza, Hartford, Connecticut 06103; serving as Penterra's clinical trial liability insurer for the CLARION trial. Policy No.: BM-CTL-2023-04182. Underwriter contact: Karen Tremblay, Vice President, Life Sciences Lines.
3. Pinnacle Data Solutions, Inc. — a corporation organized and existing under the laws of
3. Pinnacle Data Solutions, Inc. — a corporation organized and existing under the laws of the State of Delaware; principal address: 6000 Clearwater Drive, San Diego, California 92121; serving as the electronic data capture ("EDC") and eClinical platform vendor for the CLARION trial.
4. Northbridge Bioanalytical Laboratories, Inc. — a corporation organized under the laws
4. Northbridge Bioanalytical Laboratories, Inc. — a corporation organized under the laws of the State of Maryland; principal address: 2900 Commerce Way, Baltimore, Maryland 21224; providing central laboratory services for pharmacokinetic/pharmacodynamic ("PK/PD") analyses, biomarker assessments, and safety laboratory analyses in connection with the CLARION trial. F. Other Advisors (to Penterra — Checked for Inter-Adv
1. Castleton & Hargrove LLP — a limited liability partnership organized under the laws of
1. Castleton & Hargrove LLP — a limited liability partnership organized under the laws of the District of Columbia; principal office: 1100 Connecticut Avenue NW, Suite 900, Washington, DC 20036; serving as FDA regulatory counsel to Penterra in connection with IND 157823 and the CLARION trial regulatory strategy. Lead partner: Dr. Priya Sundaram, Esq.
2. Townsend Independent Auditors LLP — a limited liability partnership organized under th
2. Townsend Independent Auditors LLP — a limited liability partnership organized under the laws of the State of New York; principal office: One Liberty Plaza, 22nd Floor, New York, New York 10006; serving as Penterra's external auditor for financial statement audits and SEC reporting purposes. Lead audit partner: Robert Chen, CPA.
3. Ridgeline Capital Markets LLC — a limited liability company organized under the laws o
3. Ridgeline Capital Markets LLC — a limited liability company organized under the laws of the State of New York; principal office: 383 Madison Avenue, 18th Floor, New York, New York 10179; serving as financial advisor to Penterra on capital allocation strategy for the Phase III clinical development program, including funding for the CLARION trial.
IV. Conflict Check Methodology
IV. Conflict Check Methodology The conflict check was conducted in accordance with Calderwood & Harkness LLP's Conflict of Interest Policy (Firm Policy No. GC-2021-003, as amended October 2022) and applicable professional responsibility rules. The following methodology was employed: Database Search. The firm's enterprise-wide conflicts database, IntaCheck (Version 8.4, Pinnacle Solutions), was searched using the foll
V. Results of Conflict Check
Medium
⚑ Confidentiality undertaking
V. Results of Conflict Check The results of the conflict check are reported below, organized by party or entity category, corresponding to the categories set forth in Section III above. A. Penterra Pharmaceuticals Corp. A comprehensive search of the IntaCheck system using all search parameters described in Section IV returned no results indicating any current or prior representation of Penterra Pharmaceuticals Corp.
I. Northbridge Bioanalytical Laboratories, Inc.
I. Northbridge Bioanalytical Laboratories, Inc. A comprehensive search of the IntaCheck system returned no results indicating any current or prior representation of Northbridge Bioanalytical Laboratories, Inc. by Calderwood & Harkness LLP. No results were identified indicating any current or prior adverse representation against Northbridge. Result: Clear. J. Castleton & Hargrove LLP A comprehensive search of the Inta
VI. Issue Conflict Analysis
High
⚑ Indemnity / guarantee obligation
VI. Issue Conflict Analysis In addition to the party-specific conflict searches described in Section V above, the undersigned conducted a broader issue conflict analysis to identify potential conflicts that might not be captured by entity- or individual-name searches but could nonetheless impair the firm's ability to represent Penterra effectively or ethically. The issue conflict analysis addressed the following area
VII. Ethical Walls / Special Procedures
VII. Ethical Walls / Special Procedures Based on the results of the comprehensive conflict check described in Sections IV through VI above, no ethical walls, information barriers, or screening procedures are required in connection with this engagement. No attorney at Calderwood & Harkness LLP has been identified as having a prior or concurrent relationship with any party to this matter that would necessitate the impo
VIII. Conclusion and Clearance
VIII. Conclusion and Clearance Based on the comprehensive conflict of interest check described in this memorandum, including the full-firm database search of the IntaCheck system, the review of active and recently closed matters, the cross-referencing of the firm's current client roster and lateral hire portability lists, the Healthcare & Life Sciences Practice Group active matter review, and the issue conflict analy
IX. Review and Approval
IX. Review and Approval Prepared by: Christopher Aiken, Associate Healthcare & Life Sciences Practice Group Calderwood & Harkness LLP Reviewed and Approved by: Miriam Calloway, Partner Healthcare & Life Sciences Practice Group Calderwood & Harkness LLP Date of Clearance: March 20, 2023 PREPARED BY: By: ________ Name: Christopher Aiken Title: Associate, Healthcare & Life Sciences Practice Group Date: March 20, 2023 RE
X. Appendix — Parties and Entities Search Summary Table
Medium
⚑ Confidentiality undertaking
X. Appendix — Parties and Entities Search Summary Table The following table provides a comprehensive summary of all parties and entities checked in connection with this conflict of interest review, the search terms used, any hits identified, the disposition of each hit, and the final clearance status for each entry. A. Client and Client Affiliates B. Counterparty and Counterparty Affiliates C. Participating Site Inst