PENTERRA PHARMACEUTICALS CORP. 200 Biopharma Boulevard, Suite 1400 Princeton, New Jersey 08540 Tel: (609) 555-8400
March 20, 2023
Miriam Calloway, Esq. Partner, Healthcare & Life Sciences Practice Group Calderwood & Harkness LLP 280 Park Avenue, 34th Floor New York, NY 10017
Re: Acknowledgment and Acceptance of Engagement Letter and Retainer Terms Matter No.: 1018-00004 Matter: Penterra Pharmaceuticals Corp. — Master Clinical Trial Agreement and Site-Network Agreements for Protocol PPC-4871-III (CLARION)
Dear Ms. Calloway:
I write in my capacity as Vice President and General Counsel of Penterra Pharmaceuticals Corp. ("Penterra" or "PPC"), a corporation organized and existing under the laws of the State of Delaware and publicly traded on the Nasdaq Stock Market under the ticker symbol PTRA, with its principal offices located at 200 Biopharma Boulevard, Suite 1400, Princeton, New Jersey 08540. In that capacity, I serve as an authorized signatory on behalf of Penterra for the purposes of engagement of outside counsel and related legal services matters.
This letter confirms Penterra's receipt of Calderwood & Harkness LLP's engagement letter dated March 20, 2023 (the "Engagement Letter"), and serves to formally acknowledge and accept the terms and conditions set forth therein regarding Calderwood & Harkness LLP's representation of Penterra in connection with the negotiation, drafting, and finalization of the Master Clinical Trial Agreement (the "MCTA") and all associated site-network agreements, as described more fully below. We appreciate the thoroughness of the Engagement Letter and are pleased to confirm our acceptance of its terms in all respects.
Scope of Engagement Acknowledged
Penterra acknowledges and confirms its understanding that the scope of the engagement described in the Engagement Letter encompasses Calderwood & Harkness LLP's legal representation of Penterra, in its capacity as Sponsor, in connection with the negotiation, drafting, review, and finalization of the MCTA and ancillary agreements to be entered into between Penterra and Veridian Health Research Network, Inc. ("Veridian"), a Delaware not-for-profit corporation exempt from federal income taxation under Section 501(c)(3) of the Internal Revenue Code of 1986, as amended, with its principal offices located at 750 Research Parkway, 8th Floor, Philadelphia, Pennsylvania 19104.
The MCTA will govern the conduct and administration of Protocol PPC-4871-III, designated internally by Penterra under the trial name CLARION (Clinical Assessment of Response with Longitudinal Investigation in ONcology). The CLARION trial is a Phase III, randomized, double-blind, placebo-controlled, multi-center clinical trial evaluating the safety and efficacy of penterafenib (PPC-4871), an oral multi-kinase inhibitor, in the treatment of patients with advanced hepatocellular carcinoma (HCC). The investigational product is being studied under Investigational New Drug Application Number IND 157823, as filed with the United States Food and Drug Administration ("FDA"), and the trial is registered with ClinicalTrials.gov under identifier NCT05928174.
Without limiting the generality of the foregoing, Penterra understands that the scope of Calderwood & Harkness LLP's engagement includes the following categories of work:
(a) Negotiation and drafting of the MCTA between Penterra and Veridian, including all exhibits, schedules, appendices, and ancillary documents attached thereto or incorporated therein by reference;
(b) Preparation and negotiation of individual site joinder agreements for each of the thirty-eight (38) Veridian Network clinical trial sites located across fourteen (14) states, through which Veridian will coordinate the conduct of the CLARION trial;
(c) Drafting and negotiation of individual investigator agreements to be executed by each principal investigator and sub-investigator at the participating sites;
(d) Preparation and negotiation of an intellectual property side letter addressing inventions, discoveries, data ownership, publication rights, and related intellectual property matters arising out of or in connection with the CLARION trial;
(e) Review and negotiation of insurance-related correspondence, including certificates of insurance, additional insured endorsements, and indemnification provisions as they relate to sponsor liability, clinical trial insurance, and site-level coverage;
(f) Preparation of closing deliverables, including officer's certificates, bring-down confirmations, legal opinions (if required), and signature pages; and
(g) Such other legal services as may be reasonably necessary or incident to the foregoing matters, as mutually agreed upon by the parties.
Penterra further acknowledges that the total deal value of the MCTA is approximately Eighty Million Dollars ($80,000,000), which sum encompasses the aggregate of per-patient site fees, site start-up fees, site maintenance and operational fees, investigator grants, network coordination fees payable to Veridian, technology and electronic data capture (EDC) integration costs, and contingency reserves, all as projected over the anticipated forty-two (42) month enrollment period and sixty (60) month total study duration. Penterra understands that this deal value figure is relevant to the scope and complexity of the engagement, and that it has been used by Calderwood & Harkness LLP in assessing appropriate staffing and resource allocation for this matter.
Acknowledgment of Engagement Team
Penterra confirms its understanding and acceptance of the Calderwood & Harkness LLP engagement team assigned to this matter, as set forth in the Engagement Letter:
• Miriam Calloway, Partner — Responsible Partner, Healthcare & Life Sciences Practice Group. Ms. Calloway will serve as the partner with overall supervisory responsibility for the engagement and will be the senior point of contact at Calderwood & Harkness LLP for strategic and significant substantive legal issues arising in connection with the MCTA and related agreements.
• Joel Strauss, Partner — Billing Partner, Healthcare & Life Sciences Practice Group. Mr. Strauss will serve as the billing partner responsible for the preparation and issuance of invoices and the administration of billing-related matters for this engagement.
• Sean Morrissey, Associate — Lead Associate. Mr. Morrissey will serve as the primary associate responsible for day-to-day drafting, negotiation support, and coordination of work product across the engagement team.
• Christopher Aiken, Associate — Working Associate. Mr. Aiken will support Mr. Morrissey and the broader engagement team with research, drafting, document management, and other tasks as assigned.
Penterra designates the following individuals as its primary contacts for day-to-day matters arising in connection with this engagement:
• Rebecca Liang, Esq., Associate General Counsel, Clinical Affairs, Penterra Pharmaceuticals Corp. Ms. Liang will serve as Penterra's primary day-to-day legal contact for the engagement and will be the principal point of communication between Penterra's in-house legal team and the Calderwood & Harkness LLP engagement team. All routine correspondence, draft documents, and scheduling communications should be directed to Ms. Liang in the first instance, unless otherwise instructed.
• Samantha Novak, Director, Clinical Contracts, Penterra Pharmaceuticals Corp. Ms. Novak may be involved in the review of site joinder agreements, investigator agreements, and operational provisions of the MCTA, and may participate in negotiation sessions and calls as appropriate.
• Jennifer Holt, Vice President, Clinical Operations, Penterra Pharmaceuticals Corp. Ms. Holt may provide operational input on matters relating to site activation timelines, protocol conduct, and trial management logistics, and may be consulted from time to time on business terms of the MCTA and ancillary agreements.
Penterra requests that Calderwood & Harkness LLP notify Penterra promptly in the event of any material change to the composition of the engagement team.
Acceptance of Fee Structure and Billing Terms
Penterra hereby acknowledges and accepts the fee structure as outlined in the Engagement Letter, including the applicable hourly rates for partners, associates, and support staff assigned to this matter. Penterra has reviewed the rate schedule appended to the Engagement Letter and confirms that the rates quoted therein are acceptable and consistent with the terms previously discussed between the parties.
Penterra further confirms its acceptance of Joel Strauss as the billing partner for this engagement and acknowledges the invoicing and payment terms set forth in the Engagement Letter, including the frequency of invoicing, the payment period following receipt of each invoice, and the treatment of disbursements and out-of-pocket expenses. Penterra understands and agrees that invoices will be rendered in accordance with the schedule and format described in the Engagement Letter, and that all invoices shall comply with Penterra's outside counsel billing guidelines, a copy of which has been previously provided to Calderwood & Harkness LLP.
Penterra hereby confirms that it will provide the initial retainer deposit as specified in the Engagement Letter within the timeframe and in the manner described therein. Penterra understands that the retainer deposit will be held by Calderwood & Harkness LLP in its client trust account in accordance with applicable rules of professional conduct and that the retainer will be applied as set forth in the Engagement Letter.
Matter Number
Penterra acknowledges the assignment of Calderwood & Harkness LLP internal matter number 1018-00004 to this engagement. Penterra respectfully requests that all invoices, correspondence, communications, and other documents relating to this matter reference this matter number to facilitate proper tracking, allocation, and recordkeeping on both sides. Penterra's corresponding internal matter reference is PPC-LEG-2023-0471, and Penterra requests that Calderwood & Harkness LLP include this internal reference on all invoices submitted to Penterra for this engagement.
Governing Law of Engagement
Penterra notes and acknowledges that the Engagement Letter is governed by the laws of the State of New York, without regard to principles of conflicts of law. This choice of governing law is consistent with the anticipated governing law of the MCTA itself and is acceptable to Penterra.
Counterparty and Key Third-Party Acknowledgments
Penterra acknowledges that Calderwood & Harkness LLP has conducted, and has confirmed clearance of, the requisite conflict-of-interest checks in connection with this engagement, including conflict checks run against the following parties:
(a) Veridian Health Research Network, Inc.;
(b) Graystone University Medical Center, a participating Veridian Network site;
(c) Lakemont Medical Center, a participating Veridian Network site;
(d) Whitmore, Jansen & Callahan LLP, outside counsel to Veridian; and
(e) Such other parties as Calderwood & Harkness LLP has identified as relevant to the conflict clearance process for this engagement.
Penterra is aware that Veridian is represented in connection with the MCTA and related agreements by Whitmore, Jansen & Callahan LLP, located at 1500 Market Street, Suite 3200, Philadelphia, Pennsylvania 19102, with Allison Whitmore, Esq., Partner, serving as lead counsel for Veridian.
Penterra further notes, for the avoidance of doubt, that Penterra has separately engaged Castleton & Hargrove LLP, located at 1100 Connecticut Avenue NW, Suite 900, Washington, DC 20036, as its FDA regulatory counsel in connection with the CLARION trial and related regulatory matters. The lead partner for that engagement is Dr. Priya Sundaram, Esq. Penterra acknowledges and confirms that the Castleton & Hargrove engagement is entirely outside the scope of Calderwood & Harkness LLP's representation under the Engagement Letter, and that Calderwood & Harkness LLP bears no responsibility for, and has no involvement in, the regulatory aspects of the CLARION trial or Penterra's interactions with the FDA, except to the extent that coordination between the two outside counsel engagements may be necessary or desirable in connection with specific provisions of the MCTA (e.g., regulatory reporting obligations, IND safety reporting, or regulatory termination rights), in which case such coordination shall be undertaken at Penterra's direction and under Penterra's supervision.
Authorization
I, Nathaniel Briggs, Esq., hereby confirm that I am duly authorized to execute this acknowledgment letter on behalf of Penterra Pharmaceuticals Corp. The engagement of Calderwood & Harkness LLP for this matter has been reviewed and approved by Penterra's Board of Directors and executive leadership, including our Chief Executive Officer, Dr. Anand Raghavan, M.D., Ph.D. This acknowledgment letter constitutes the binding act of Penterra and reflects the corporate authorization necessary to retain Calderwood & Harkness LLP for the representation described herein.
We look forward to working with you and your team on this important matter. Please do not hesitate to contact me directly, or Rebecca Liang, should you have any questions or require any additional information.
Very truly yours,
PENTERRA PHARMACEUTICALS CORP.
By: ________
Name: Nathaniel Briggs, Esq.
Title: Vice President & General Counsel
Date: March 20, 2023
Enclosure: Countersigned copy of Calderwood & Harkness LLP Engagement Letter dated March 20, 2023
cc:
Rebecca Liang, Esq., Associate General Counsel, Clinical Affairs, Penterra Pharmaceuticals Corp.
Dr. Anand Raghavan, M.D., Ph.D., Chief Executive Officer, Penterra Pharmaceuticals Corp.
Joel Strauss, Esq., Partner, Calderwood & Harkness LLP