MEMORANDUM
PRIVILEGED & CONFIDENTIAL ATTORNEY WORK PRODUCT
TO: Miriam Calloway, Partner, Healthcare & Life Sciences Practice Group
FROM: Christopher Aiken, Associate, Healthcare & Life Sciences Practice Group
DATE: March 20, 2023
RE: Conflict of Interest Check — Penterra Pharmaceuticals Corp. / Veridian Health Research Network, Inc. Master Clinical Trial Agreement Matter
Matter No.: 1018-00004
Status: CLEARED
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. ("Veridian" or "VHRN") for Penterra's Phase III clinical trial of penterafenib (PPC-4871), Protocol PPC-4871-III (the "CLARION" trial). The CLARION trial is a pivotal Phase III, randomized, double-blind, placebo-controlled study evaluating penterafenib in patients with advanced hepatocellular carcinoma ("HCC"), and the MCTA will serve as the master framework agreement governing clinical research activities across the Veridian network of investigative sites.
The estimated aggregate deal value of the MCTA and associated site-network agreements is approximately Eighty Million Dollars ($80,000,000), representing per-patient fees, investigator grants, institutional overhead, and ancillary service charges projected across thirty-eight (38) Veridian Network clinical sites over the anticipated life of the CLARION trial, which is expected to span approximately four (4) years from first patient enrolled through database lock and final clinical study report.
This conflict check was initiated on March 20, 2023, coinciding with the formal opening of Matter No. 1018-00004 in the firm's matter management system, and was completed on the same date. All searches, reviews, and analyses described herein were conducted in accordance with Calderwood & Harkness LLP's Conflict of Interest Policy (Firm Policy No. GC-2021-003, as amended October 2022), the New York Rules of Professional Conduct (particularly Rules 1.7, 1.8, 1.9, 1.10, and 1.18), and applicable American Bar Association Model Rules of Professional Conduct.
The purpose of this memorandum is to provide a permanent record of the conflict check process, methodology, and results for the firm's files and to confirm that the proposed engagement is cleared for commencement.
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, Suite 1400, Princeton, New Jersey 08540. Penterra is a mid-cap biopharmaceutical company focused on the development of novel targeted therapies and immuno-oncology agents for the treatment of solid tumors, with a primary focus on liver, biliary, and gastrointestinal malignancies. The company's lead clinical-stage asset is penterafenib (PPC-4871), a selective multi-kinase inhibitor currently under investigation pursuant to IND 157823.
Client Contacts:
• Nathaniel Briggs, Esq., Vice President & General Counsel, Penterra Pharmaceuticals Corp.
• Rebecca Liang, Esq., Associate General Counsel, Clinical Affairs, Penterra Pharmaceuticals Corp.
Matter Description: The engagement encompasses the full scope of transactional legal services required for the negotiation and finalization of the MCTA between Penterra (as Sponsor) and Veridian (as Site Network) for Protocol PPC-4871-III (CLARION). The CLARION trial is a Phase III, randomized, double-blind, placebo-controlled, multi-center study evaluating the efficacy and safety of penterafenib versus placebo in combination with standard-of-care systemic therapy in approximately 680 adult patients with unresectable or metastatic hepatocellular carcinoma. The trial is registered with ClinicalTrials.gov under identifier NCT05928174.
The total deal value of the MCTA and associated site-network agreements is estimated at approximately $80,000,000, encompassing per-patient clinical trial fees, investigator grant payments, institutional overhead and indirect cost allocations, pharmacy and laboratory fees, and ancillary service charges across the Veridian Network. The engagement specifically includes, but is not limited to, the following deliverables:
(a) Drafting and negotiation of the Master Clinical Trial Agreement between Penterra and Veridian;
(b) Drafting and negotiation of the form Site Joinder Agreement for execution by individual Veridian Network member institutions;
(c) Drafting and negotiation of an intellectual Property Side Letter addressing background IP, foreground IP, publication rights, and data ownership matters arising from the CLARION trial;
(d) Review and negotiation of individual Investigator Agreements for principal investigators at key Veridian Network sites, including customary confidentiality, non-competition, and publication provisions;
(e) Coordination and review of clinical trial insurance provisions, including alignment of Penterra's clinical trial liability insurance coverage with Veridian's institutional insurance requirements;
(f) Preparation of closing deliverables, including officer's certificates, bring-down representations, and conditions precedent documentation; and
(g) Such other ancillary agreements, amendments, and related transactional documents as may be necessary to effectuate the purposes of the MCTA.
Responsible Partner: Miriam Calloway, Partner, Healthcare & Life Sciences Practice Group
Billing Partner: Joel Strauss, Partner, Healthcare & Life Sciences Practice Group
Lead Associate: Sean Morrissey, Senior Associate, Healthcare & Life Sciences Practice Group
Working Associate: Christopher Aiken, Associate, Healthcare & Life Sciences Practice Group
Governing Law (anticipated): The parties have indicated a mutual preference for the laws of the State of New York to govern the MCTA, without regard to conflict of laws principles. Forum selection provisions are anticipated to designate the state and federal courts located in the Borough of Manhattan, New York, New York.
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 and individuals were checked as the client and client-side affiliates:
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 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 Pharmaceuticals Corp.
5. Jennifer Holt — Vice President, Clinical Operations, Penterra Pharmaceuticals Corp.
6. Nathaniel Briggs, Esq. — Vice President & General Counsel, Penterra Pharmaceuticals Corp.
7. Rebecca Liang, Esq. — Associate General Counsel, Clinical Affairs, 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; 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 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 hospitals, and integrated health systems that participate in sponsored clinical research across multiple therapeutic areas.
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.
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 Network, Inc.
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 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 Medical Center.
(b) Dr. Catherine Aldridge, M.D., Ph.D. — Professor of Oncology, Department of Medical Oncology, Graystone University Medical Center; designated as the Global Principal Investigator for the CLARION trial (Protocol PPC-4871-III).
(c) Graystone University Institutional Review Board — IRB Registration No.: IRB00012847 (OHRP/DHHS registration); will serve as the reviewing IRB for the Graystone site and potentially for other Pennsylvania-based Veridian Network sites.
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-Principal Investigator for the CLARION trial.
(b) Veridian Central IRB — The Veridian Central IRB, administered through Veridian Health Research Network, will serve as the single IRB of record for non-Pennsylvania Veridian Network sites participating in the CLARION trial, including Lakemont Medical Center.
Note Regarding Remaining Network Sites: The remaining thirty-six (36) Veridian Network sites anticipated to participate in the CLARION trial are distributed across fourteen (14) states. These sites were checked at the network/parent level (i.e., through the Veridian Health Research Network entity search). Individual site institutions have not yet been formally identified or activated by Penterra's clinical operations team. Supplemental conflict checks will be performed against each individual site institution, its principal investigator(s), and any relevant affiliated individuals as sites are identified and prior to the execution of individual site joinder agreements. This approach is consistent with the firm's standard practice for multi-site clinical trial engagements where site activation occurs on a rolling basis.
D. Counterparty's Outside Counsel
The following law firm and individuals were checked as Veridian's outside counsel for the MCTA negotiation:
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 Kesselman — Associate, Whitmore, Jansen & Callahan LLP; working associate on the Veridian MCTA matter.
E. Third-Party Service Providers and Vendors
The following third-party service providers and vendors involved in or related to the CLARION trial were included in the conflict check:
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, 2023, which is not within the scope of this engagement but was checked for potential adverse representation or positional conflict concerns.
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 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 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-Advisor Conflict)
The following entities and individuals were checked as other professional advisors to Penterra to ensure no inter-advisor conflicts exist that could impair Calderwood & Harkness's ability to serve the client effectively:
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 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 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
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 following search parameters:
(a) Entity name searches: All entity names listed in Section III above were searched using full legal names, common short names, known trade names, and "doing business as" ("d/b/a") names. For example, "Penterra Pharmaceuticals Corp." was searched as "Penterra Pharmaceuticals," "Penterra Pharma," "PPC," and "Penterra"; "Veridian Health Research Network, Inc." was searched as "Veridian Health," "Veridian Research," "VHRN," and "Veridian."
(b) Individual name searches: All individual names listed in Section III above were searched using full names, common name variations, and last-name-only searches where appropriate to capture potential matches.
(c) Key identifier searches: Additional searches were conducted using key identifiers associated with the engagement, including Penterra's Nasdaq ticker symbol ("PTRA"), Veridian's Employer Identification Number ("23-4178205"), the IND number for penterafenib ("IND 157823"), and the ClinicalTrials.gov identifier for the CLARION trial ("NCT05928174").
(d) Variation and partial name searches: Phonetic, partial, and fuzzy-match searches were conducted for all entity and individual names to capture potential matches that might not be identified through exact-name searches alone. The IntaCheck system's built-in Soundex and Metaphone algorithms were utilized for this purpose.
Active and Closed Matter Review. All active matters and all matters closed within the preceding five (5) years were reviewed for any representation of, or adverse to, any of the parties and entities identified in Section III. This review encompassed matters across all of the firm's practice groups and offices, including the firm's New York, Washington, DC, Los Angeles, London, and Hong Kong offices.
Client Roster and Lateral Hire Cross-Reference. The search results were cross-referenced against the firm's current active client roster to identify any ongoing client relationships with the checked parties. Additionally, the firm's lateral hire portability lists — maintained for all lateral partners and senior associates who joined the firm within the preceding three (3) years — were reviewed to determine whether any lateral hire brought with them a client relationship involving any of the checked parties that could give rise to a conflict or imputed disqualification.
Practice Group Review. The Healthcare & Life Sciences Practice Group's active matter list was independently reviewed to identify potential issue conflicts, including any pending or contemplated representations that might involve the assertion of legal positions materially adverse to positions that Penterra may take in the MCTA negotiation. This review was conducted by the undersigned in consultation with Joel Strauss, the Billing Partner for this engagement.
Personal Relationship Inquiry. Inquiries were made within the deal team (i.e., Miriam Calloway, Joel Strauss, Sean Morrissey, and Christopher Aiken) regarding any personal, familial, or financial relationships with any of the individuals named in Section III. No such relationships were identified.
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. by Calderwood & Harkness LLP. Similarly, no results were identified indicating any current or prior adverse representation against Penterra by the firm in any matter, whether litigation, transactional, regulatory, or advisory in nature. Penterra does not appear on the firm's current active client roster, and no lateral hire portability lists reference Penterra as a former client of any lateral attorney.
Result: Clear.
B. Veridian Health Research Network, Inc.
A comprehensive search of the IntaCheck system returned no results indicating any current or prior representation of Veridian Health Research Network, Inc. by Calderwood & Harkness LLP. No results were identified indicating any current or prior adverse representation against Veridian by the firm. Veridian does not appear on the firm's current active client roster, and no lateral hire portability lists reference Veridian as a former client.
During the course of the individual name searches, it was noted that Gregory Callahan, Esq., Vice President, Legal & Compliance at Veridian, shares a surname with a named partner at Whitmore, Jansen & Callahan LLP, Veridian's outside counsel for this matter. Based on publicly available biographical information and inquiries made of the deal team, it has been confirmed that these are different individuals with no familial relationship known to the firm. Gregory Callahan of Veridian is an in-house attorney whose professional background is in healthcare compliance and nonprofit governance, whereas the "Callahan" in the Whitmore, Jansen & Callahan firm name refers to Patrick J. Callahan, a founding partner whose practice focuses on real estate and municipal finance. This surname coincidence does not give rise to any conflict or potential conflict.
Result: Clear.
C. Graystone University Medical Center
A comprehensive search of the IntaCheck system returned no results indicating any current representation of Graystone University Medical Center by Calderwood & Harkness LLP. No results were identified indicating any current adverse representation against Graystone.
One prior matter was identified in the search results: Matter No. 1018-00004, in which Calderwood & Harkness represented Dr. Thomas Fielding, a former faculty member of Graystone University Medical Center, in an unrelated employment dispute involving claims of wrongful termination and breach of an academic appointment agreement. That matter was resolved by settlement and formally closed on August 14, 2019. Dr. Fielding is no longer affiliated with Graystone, and no ongoing attorney-client relationship exists between the firm and either Dr. Fielding or Graystone in connection with that matter. The subject matter of the prior representation (individual employment dispute) bears no substantive relationship to the current proposed engagement (institutional clinical trial agreement). Accordingly, the prior matter does not give rise to a conflict under Rule 1.9 of the New York Rules of Professional Conduct, as the matters are not the same or substantially related, and there is no reasonable possibility that confidential information obtained in the prior representation would be material to the current engagement.
Result: Clear.
D. Lakemont Medical Center
A comprehensive search of the IntaCheck system returned no results indicating any current or prior representation of Lakemont Medical Center by Calderwood & Harkness LLP. No results were identified indicating any current or prior adverse representation against Lakemont. Lakemont does not appear on the firm's current active client roster.
Result: Clear.
E. Whitmore, Jansen & Callahan LLP
A comprehensive search of the IntaCheck system returned no results indicating any current representation of Whitmore, Jansen & Callahan LLP by Calderwood & Harkness LLP, nor any current representation of Calderwood & Harkness by WJC. No prior matters were identified in which WJC appeared as counterparty counsel in circumstances that would create a positional or issue conflict with respect to the current engagement. A review of the firm's lateral hire records confirmed that no attorneys have joined Calderwood & Harkness from WJC within the preceding five (5) years, and accordingly there are no imputed disqualification or screening concerns arising from lateral movement.
Result: Clear.
F. Meridian Contract Research Organization, Inc.
A comprehensive search of the IntaCheck system returned no results indicating any current or prior representation of Meridian Contract Research Organization, Inc. by Calderwood & Harkness LLP. No results were identified indicating any current or prior adverse representation against Meridian CRO. Although Meridian CRO is a significant third-party vendor to Penterra in connection with the CLARION trial (pursuant to a separate Master Services Agreement dated January 15, 2023), the absence of any firm relationship with Meridian CRO, whether as client or adverse party, eliminates any potential for conflict arising from the firm's involvement in the MCTA engagement.
Result: Clear.
G. Briarcliff Mutual Insurance Company
A comprehensive search of the IntaCheck system returned no results indicating any current or prior representation of Briarcliff Mutual Insurance Company by Calderwood & Harkness LLP. No results were identified indicating any current or prior adverse representation against Briarcliff. The firm does not currently represent any party in any coverage dispute, bad faith claim, or other adversarial proceeding involving Briarcliff.
Result: Clear.
H. Pinnacle Data Solutions, Inc.
A comprehensive search of the IntaCheck system returned no results indicating any current or prior representation of Pinnacle Data Solutions, Inc. by Calderwood & Harkness LLP. No results were identified indicating any current or prior adverse representation against Pinnacle.
Result: Clear.
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 IntaCheck system returned no results indicating any current adverse representation against Castleton & Hargrove LLP by Calderwood & Harkness LLP. Castleton & Hargrove serves as FDA regulatory counsel to Penterra on matters related to IND 157823 and the CLARION trial regulatory strategy, and there is no conflict in Calderwood & Harkness concurrently representing Penterra on the transactional and contractual aspects of the MCTA engagement. The scopes of the two engagements are complementary rather than adverse, and the firm's representation of Penterra in the MCTA matter will not require the firm to take any position adverse to Castleton & Hargrove or its interests.
Result: Clear.
K. Townsend Independent Auditors LLP
A comprehensive search of the IntaCheck system returned no results indicating any current or prior representation of Townsend Independent Auditors LLP by Calderwood & Harkness LLP. No results were identified indicating any current or prior adverse representation against Townsend.
Result: Clear.
L. Ridgeline Capital Markets LLC
A comprehensive search of the IntaCheck system returned no results indicating any current or prior representation of Ridgeline Capital Markets LLC by Calderwood & Harkness LLP. No results were identified indicating any current or prior adverse representation against Ridgeline.
Result: Clear.
M. Individual Officers, Directors, and Investigators
All named individuals identified in Section III were searched individually in the IntaCheck system using full names, name variations, and last-name-only searches. No current or prior representations of, or adverse to, any of the following individuals were identified that would give rise to a conflict of interest:
• Dr. Anand Raghavan, M.D., Ph.D.
• Dr. Elaine Whitford, M.D.
• Dr. Marcus Yun, M.D., M.P.H.
• Jennifer Holt
• Nathaniel Briggs, Esq.
• Rebecca Liang, Esq.
• Samantha Novak
• Dr. Franklin Osei, M.D., Ph.D.
• Diane Prescott
• Dr. Lena Marchetti, Ph.D.
• Gregory Callahan, Esq.
• Patricia Dunne
• Dr. William Corwin, M.D.
• Dr. Catherine Aldridge, M.D., Ph.D.
• Dr. Howard Matsuoka, M.D.
• Allison Whitmore
• David Kesselman
• Thomas Hartwell
• Karen Tremblay
• Dr. Priya Sundaram, Esq.
• Robert Chen, CPA
No individual listed above appears in the firm's conflicts database as a current or former client, an adverse party, or a witness in any matter that bears a substantial relationship to the proposed engagement.
Result: Clear.
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 areas:
Sponsor-vs.-Network Representation Analysis. The undersigned reviewed the firm's active matter database to determine whether Calderwood & Harkness is currently representing any other pharmaceutical sponsor, biotechnology company, or medical device manufacturer in a dispute, negotiation, or adversarial proceeding against Veridian Health Research Network or any Veridian Network member institution on substantially similar issues, including but not limited to subject-injury indemnification and hold harmless provisions, clinical trial agreement payment terms, intellectual property ownership and licensing provisions, publication rights, or regulatory compliance obligations. No such representation was identified. The firm is not currently engaged in any matter in which it has taken, or would be expected to take, a legal position adverse to Veridian or any known Veridian Network member institution on any issue of the type likely to arise in the MCTA negotiation.
Positional Conflict Analysis. The undersigned reviewed the firm's active matters across all practice groups to determine whether Calderwood & Harkness is currently advising any client — whether in a transactional, litigation, or advisory capacity — on any matter in which the firm is advocating or has advocated a legal position that is materially adverse to a position that Penterra may reasonably be expected to take in the MCTA negotiation. This review focused on key negotiation issues typical of master clinical trial agreements, including sponsor indemnification obligations, subject-injury compensation frameworks, investigational product liability allocation, regulatory compliance responsibilities, institutional overhead rate methodologies, and data ownership and licensing structures. No such positional conflict was identified. The firm's current representations do not involve the assertion of legal positions that would be materially inconsistent with Penterra's anticipated positions in the MCTA negotiation.
Personal and Financial Relationship Review. The undersigned inquired of each member of the proposed deal team — Miriam Calloway, Joel Strauss, Sean Morrissey, and Christopher Aiken — whether any current or former Calderwood & Harkness attorney known to them has a personal, familial, social, or financial relationship with any of the named individuals at Veridian Health Research Network, Graystone University Medical Center, Lakemont Medical Center, or Whitmore, Jansen & Callahan LLP that could create an actual or perceived conflict of interest or compromise the firm's independent professional judgment. No such relationships were identified by any member of the deal team.
Result: No issue conflicts identified.
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 imposition of screening measures under Rule 1.10 of the New York Rules of Professional Conduct or the firm's internal policies governing ethical screens.
Notwithstanding the foregoing, the following ongoing procedure will be observed throughout the life of this engagement:
Supplemental Conflict Checks for Additional Sites. As noted in Section III.C above, the CLARION trial is expected to enroll patients across thirty-eight (38) Veridian Network clinical sites, of which only two (Graystone University Medical Center and Lakemont Medical Center) have been formally identified and checked as of the date of this memorandum. As additional Veridian Network sites are identified by Penterra's clinical operations team and selected for participation in the trial, supplemental conflict checks will be conducted against each such site institution, its designated principal investigator(s), and any relevant affiliated individuals prior to the execution of individual site joinder agreements. If a conflict or potential conflict is identified in connection with any supplemental check, the matter will be promptly escalated to the Responsible Partner (Miriam Calloway) and, if necessary, to the firm's General Counsel for resolution in accordance with the firm's Conflict of Interest Policy.
This supplemental checking procedure is documented in the matter file and will be communicated to the deal team at the engagement kickoff meeting.
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 analysis, no conflicts of interest have been identified that would prevent Calderwood & Harkness LLP from representing Penterra Pharmaceuticals Corp. in connection with the negotiation and finalization of the Master Clinical Trial Agreement and associated site-network agreements with Veridian Health Research Network, Inc. for Protocol PPC-4871-III (CLARION).
All parties and entities identified in Section III of this memorandum — including the client and its affiliates, the counterparty and its affiliates, participating site institutions, counterparty's outside counsel, third-party service providers and vendors, and other professional advisors to Penterra — have been checked and cleared.
This matter, No. 1018-00004, is hereby CLEARED for engagement as of March 20, 2023. The engagement team may proceed with client intake procedures, including the execution of the engagement letter with Penterra Pharmaceuticals Corp. and the commencement of substantive legal work on the MCTA and related agreements.
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
REVIEWED AND APPROVED BY:
By: ________
Name: Miriam Calloway
Title: Partner, Healthcare & Life Sciences Practice Group
Date: ________
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 Institutions (Key Sites)
D. Counterparty's Outside Counsel
E. Third-Party Service Providers and Vendors
F. Other Advisors to Penterra
END OF MEMORANDUM
This memorandum is a privileged and confidential attorney work product prepared in connection with the internal conflicts clearance process of Calderwood & Harkness LLP. It is not intended for distribution outside the firm and is subject to the protections of the attorney-client privilege and the work product doctrine. Any unauthorized disclosure, copying, or distribution of this memorandum is strictly prohibited.
| Entity / Individual | Search Terms Used | Hits Identified | Disposition | Clearance Status |
| Penterra Pharmaceuticals Corp. | "Penterra Pharmaceuticals Corp."; "Penterra Pharmaceuticals"; "Penterra Pharma"; "PPC"; "Penterra"; "PTRA" | None | N/A | Cleared |
| Dr. Anand Raghavan, M.D., Ph.D. | "Anand Raghavan"; "Raghavan, Anand"; "A. Raghavan"; "Raghavan" | None | N/A | Cleared |
| Dr. Elaine Whitford, M.D. | "Elaine Whitford"; "Whitford, Elaine"; "E. Whitford"; "Whitford" | None | N/A | Cleared |
| Dr. Marcus Yun, M.D., M.P.H. | "Marcus Yun"; "Yun, Marcus"; "M. Yun"; "Yun" | None | N/A | Cleared |
| Jennifer Holt | "Jennifer Holt"; "Holt, Jennifer"; "J. Holt"; "Holt" | None (common name; no relevant matches) | N/A | Cleared |
| Nathaniel Briggs, Esq. | "Nathaniel Briggs"; "Briggs, Nathaniel"; "N. Briggs"; "Briggs" | None | N/A | Cleared |
| Rebecca Liang, Esq. | "Rebecca Liang"; "Liang, Rebecca"; "R. Liang"; "Liang" | None | N/A | Cleared |
| Samantha Novak | "Samantha Novak"; "Novak, Samantha"; "S. Novak"; "Novak" | None | N/A | Cleared |
| Capitol Registered Agents, LLC | "Capitol Registered Agents"; "Capitol Registered"; "CRA" | None | N/A | Cleared |
| Entity / Individual | Search Terms Used | Hits Identified | Disposition | Clearance Status |
| Veridian Health Research Network, Inc. | "Veridian Health Research Network"; "Veridian Health"; "Veridian Research"; "VHRN"; "Veridian"; "23-4178205" | None | N/A | Cleared |
| Dr. Franklin Osei, M.D., Ph.D. | "Franklin Osei"; "Osei, Franklin"; "F. Osei"; "Osei" | None | N/A | Cleared |
| Diane Prescott | "Diane Prescott"; "Prescott, Diane"; "D. Prescott"; "Prescott" | None | N/A | Cleared |
| Dr. Lena Marchetti, Ph.D. | "Lena Marchetti"; "Marchetti, Lena"; "L. Marchetti"; "Marchetti" | None | N/A | Cleared |
| Gregory Callahan, Esq. | "Gregory Callahan"; "Callahan, Gregory"; "G. Callahan"; "Callahan" | Surname match noted (see WJC entry below) | Confirmed different individuals; no familial relationship | Cleared |
| Patricia Dunne | "Patricia Dunne"; "Dunne, Patricia"; "P. Dunne"; "Dunne" | None | N/A | Cleared |
| Entity / Individual | Search Terms Used | Hits Identified | Disposition | Clearance Status |
| Graystone University Medical Center | "Graystone University Medical Center"; "Graystone University"; "Graystone Medical"; "GUMC"; "Graystone" | One hit: Matter No. 1018-00004 (employment matter, closed Aug. 2019) | Prior matter unrelated; no ongoing relationship; no substantial-relationship conflict under Rule 1.9 | Cleared |
| Dr. William Corwin, M.D. | "William Corwin"; "Corwin, William"; "W. Corwin"; "Corwin" | None | N/A | Cleared |
| Dr. Catherine Aldridge, M.D., Ph.D. | "Catherine Aldridge"; "Aldridge, Catherine"; "C. Aldridge"; "Aldridge" | None | N/A | Cleared |
| Graystone University IRB | "Graystone IRB"; "IRB00012847" | None | N/A | Cleared |
| Lakemont Medical Center | "Lakemont Medical Center"; "Lakemont Medical"; "Lakemont"; "LMC" | None | N/A | Cleared |
| Dr. Howard Matsuoka, M.D. | "Howard Matsuoka"; "Matsuoka, Howard"; "H. Matsuoka"; "Matsuoka" | None | N/A | Cleared |
| Entity / Individual | Search Terms Used | Hits Identified | Disposition | Clearance Status |
| Whitmore, Jansen & Callahan LLP | "Whitmore, Jansen & Callahan"; "Whitmore Jansen"; "WJC"; "WJ&C" | None | N/A | Cleared |
| Allison Whitmore | "Allison Whitmore"; "Whitmore, Allison"; "A. Whitmore"; "Whitmore" | None | N/A | Cleared |
| David Kesselman | "David Kesselman"; "Kesselman, David"; "D. Kesselman"; "Kesselman" | None | N/A | Cleared |
| Entity / Individual | Search Terms Used | Hits Identified | Disposition | Clearance Status |
| Meridian Contract Research Organization, Inc. | "Meridian Contract Research"; "Meridian CRO"; "Meridian Research"; "Meridian" | None | N/A | Cleared |
| Thomas Hartwell (CEO, Meridian CRO) | "Thomas Hartwell"; "Hartwell, Thomas"; "T. Hartwell"; "Hartwell" | None | N/A | Cleared |
| Briarcliff Mutual Insurance Company | "Briarcliff Mutual Insurance"; "Briarcliff Mutual"; "Briarcliff Insurance"; "Briarcliff"; "BM-CTL-2023-04182" | None | N/A | Cleared |
| Karen Tremblay (VP, Briarcliff) | "Karen Tremblay"; "Tremblay, Karen"; "K. Tremblay"; "Tremblay" | None | N/A | Cleared |
| Pinnacle Data Solutions, Inc. | "Pinnacle Data Solutions"; "Pinnacle Data"; "Pinnacle Solutions"; "Pinnacle" | None | N/A | Cleared |
| Northbridge Bioanalytical Laboratories, Inc. | "Northbridge Bioanalytical"; "Northbridge Labs"; "Northbridge Laboratories"; "Northbridge" | None | N/A | Cleared |
| Entity / Individual | Search Terms Used | Hits Identified | Disposition | Clearance Status |
| Castleton & Hargrove LLP | "Castleton & Hargrove"; "Castleton Hargrove"; "C&H"; "Castleton" | None | Complementary advisor; no adverse representation | Cleared |
| Dr. Priya Sundaram, Esq. | "Priya Sundaram"; "Sundaram, Priya"; "P. Sundaram"; "Sundaram" | None | N/A | Cleared |
| Townsend Independent Auditors LLP | "Townsend Independent Auditors"; "Townsend Auditors"; "Townsend LLP"; "Townsend" | None | N/A | Cleared |
| Robert Chen, CPA | "Robert Chen"; "Chen, Robert"; "R. Chen"; "Chen" | None (common name; no relevant matches) | N/A | Cleared |
| Ridgeline Capital Markets LLC | "Ridgeline Capital Markets"; "Ridgeline Capital"; "Ridgeline Markets"; "Ridgeline" | None | N/A | Cleared |