CALDERWOOD & HARKNESS LLP 280 Park Avenue, 34th Floor New York, New York 10017

CALDERWOOD & HARKNESS LLP 280 Park Avenue, 34th Floor New York, New York 10017
CLOSING BINDER INDEX AND TABLE OF CONTENTS
Master Clinical Trial Agreement and Ancillary Agreements
Protocol PPC-4871-III (CLARION — Clinical Assessment of Response with Longitudinal Investigation in ONcology)
Between
PENTERRA PHARMACEUTICALS CORP. (Sponsor)
and
VERIDIAN HEALTH RESEARCH NETWORK, INC. (Site Network)
Signing Date: June 28, 2023 Closing Date: July 5, 2023 Effective Date: July 18, 2023
Total Deal Value: $80,000,000
Matter Number: 1018-00004 Responsible Partner: Miriam Calloway Billing Partner: Joel Strauss
Date of Binder Assembly: July 18, 2023
CLOSING BINDER — INDEX AND TABLE OF CONTENTS
MASTER CLINICAL TRIAL AGREEMENT AND ANCILLARY AGREEMENTS
Protocol PPC-4871-III (CLARION)
Penterra Pharmaceuticals Corp. / Veridian Health Research Network, Inc.
Matter No. 1018-00004
Right-click to update Table of Contents
VOLUME I — PRINCIPAL TRANSACTION AGREEMENT
Volume I contains the fully executed Master Clinical Trial Agreement between Penterra Pharmaceuticals Corp. and Veridian Health Research Network, Inc., together with all execution-version signature pages of the parties thereto. The Master Clinical Trial Agreement was executed on June 28, 2023, with a closing date of July 5, 2023, and an effective date of July 18, 2023.
Tab 1 — Execution Version: Master Clinical Trial Agreement
Tab 2 — MCTA Signature Pages — Penterra Pharmaceuticals Corp.
Tab 3 — MCTA Signature Pages — Veridian Health Research Network, Inc.
Tab 4 — MCTA Signature Pages — Graystone University Medical Center (Lead Site)
VOLUME II — MCTA EXHIBITS
Volume II contains the executed exhibits to the Master Clinical Trial Agreement, identified as Exhibits A through K. These exhibits are incorporated by reference into, and form an integral part of, the MCTA. Each exhibit is tabbed separately for ease of reference.
Tab 5 — Exhibit A: Protocol Synopsis (PPC-4871-III / CLARION)
Tab 6 — Exhibit B: Budget and Payment Schedule
Budget Summary:
Payment Terms: Net 45 days from receipt of a proper invoice submitted in accordance with the invoicing procedures set forth in the MCTA.
Per-Patient Milestone Payments: The per-patient site fee of $52,000 per subject is payable in four equal installments of $13,000 each, triggered upon achievement of the following milestones: (i) subject randomization; (ii) completion of the Week 12 assessment visit; (iii) completion of the Week 24 assessment visit; and (iv) subject study completion (including early termination with required follow-up data collection).
Start-Up Fee Installments: The start-up fee of $75,000 per site is payable in two equal installments: (i) $37,500 upon site activation (defined as IRB approval, site initiation visit completion, and regulatory document package clearance); and (ii) $37,500 upon enrollment of the first patient at such site.
Tab 7 — Exhibit C: Form of Individual Site Agreement (Joinder)
Tab 8 — Exhibit D: Subject-Injury Indemnification Provisions
(a) Sponsor Indemnification of Sites and Investigators:
Penterra Pharmaceuticals Corp. shall indemnify, defend, and hold harmless each participating Veridian Network site and each investigator from and against all claims, losses, damages, liabilities, costs, and expenses (including reasonable attorneys' fees) arising from injuries to clinical trial subjects, subject to the following limitations and conditions:
•  Per-Subject Medical Care Cap: $500,000 per subject for costs of medical care arising from study-related injuries.
•  Aggregate Cap: $15,000,000 in the aggregate across all sites and all subjects for the duration of the study.
•  Product-Defect Claims: Sponsor indemnification is uncapped with respect to claims arising from defects in the investigational product (penterafenib), including manufacturing defects, design defects, and failure to provide adequate warnings in the Investigator's Brochure.
(b) Carve-Outs from Sponsor Indemnification:
Sponsor indemnification does not extend to claims arising from: (i) the negligence or willful misconduct of an investigator or site personnel; (ii) unauthorized deviations from the Protocol; or (iii) a material breach by the site or investigator of the MCTA or the applicable Individual Site Agreement.
(c) Reciprocal Site Indemnification:
Each Veridian Network site shall indemnify, defend, and hold harmless Penterra from and against claims arising from the negligence or willful misconduct of such site or its personnel, subject to the following limitations:
•  Per-Site / Per-Occurrence Cap: $5,000,000 per site per occurrence.
•  Aggregate Cap: $20,000,000 in the aggregate across all Veridian Network sites.
(d) Notice Requirement:
The party seeking indemnification must provide written notice to the indemnifying party within 30 calendar days of becoming aware of a claim or potential claim giving rise to an indemnification obligation.
(e) Defense and Settlement Procedures:
The indemnifying party shall have the right to assume and control the defense of any indemnified claim, subject to the indemnified party's right to participate with separate counsel at its own expense. No settlement may be agreed to without the prior written consent of the indemnified party, which consent shall not be unreasonably withheld, conditioned, or delayed.
Tab 9 — Exhibit E: Insurance Requirements and Certificate Forms
(a) Penterra Clinical Trial Liability Insurance:
•  Carrier: Briarcliff Mutual Insurance Company
•  Policy Number: BM-CTL-2023-04182
•  Limits: $25,000,000 per occurrence / $75,000,000 in the aggregate
•  Subject-Injury Sublimit: $10,000,000 per occurrence / $50,000,000 in the aggregate
•  Additional Insureds: Veridian Health Research Network, Inc. and each participating Veridian Network site shall be named as additional insureds under the policy
(b) Veridian / Site Insurance:
•  Required Coverage: General liability and professional liability insurance
•  Minimum Limits: $5,000,000 per occurrence / $10,000,000 in the aggregate
•  Applicable To: Veridian Health Research Network, Inc. and each participating Veridian Network site
(c) Certificate Exchange Deadline:
All certificates of insurance shall be exchanged within 15 business days of execution of the MCTA (i.e., by July 21, 2023).
(d) Forms:
Exhibit E includes the prescribed forms for: (i) certificate of insurance; and (ii) additional insured endorsement.
Tab 10 — Exhibit F: Confidentiality and Data Protection Provisions
Permitted Disclosures: Confidential Information may be disclosed to: (i) Institutional Review Boards with jurisdiction over the conduct of the study at a participating site; (ii) regulatory authorities (including the FDA, EMA, and other health authorities) as required by applicable law or regulation; and (iii) each party's legal counsel, auditors, and consultants, provided that such recipients are bound by obligations of confidentiality no less restrictive than those set forth in Exhibit F.
Data Security Obligations: Each party shall implement and maintain reasonable administrative, technical, and physical safeguards to protect Confidential Information against unauthorized access, use, or disclosure, consistent with industry standards for the protection of clinical trial data and personal health information.
HIPAA Compliance: The parties acknowledge that the conduct of the CLARION trial will involve the use and disclosure of Protected Health Information ("PHI") as defined under the Health Insurance Portability and Accountability Act of 1996, as amended, and the regulations promulgated thereunder at 45 C.F.R. Parts 160 and 164. The parties shall comply with all applicable requirements of HIPAA and shall enter into Business Associate Agreements as necessary.
Tab 11 — Exhibit G: Intellectual Property and Publication Rights
(a) Ownership of Clinical Trial Data: Penterra Pharmaceuticals Corp. retains exclusive ownership of all clinical trial data generated in connection with the CLARION trial, including but not limited to case report form data, laboratory data, imaging data, pharmacokinetic and pharmacodynamic data, biomarker data, and safety data.
(b) Pre-Existing intellectual Property: Each party retains all right, title, and interest in and to its pre-existing intellectual property. Nothing in the MCTA or this Exhibit G shall be construed to transfer ownership of any party's pre-existing intellectual property to any other party.
(c) Joint Inventions: Inventions that are jointly developed by personnel of Penterra and personnel of a participating site or the Veridian Network shall be governed by the intellectual Property Side Letter executed concurrently with the MCTA (see Tab 24 of this closing binder).
(d) Publication Rights: Investigators may publish the results of the CLARION trial, subject to the following conditions:
•  Investigators shall submit proposed manuscripts, abstracts, and presentations to Penterra for review at least 60 calendar days prior to the intended date of submission for publication or presentation.
•  Penterra may review the proposed publication solely for the purpose of identifying Confidential Information and patentable subject matter.
•  If Penterra identifies patentable subject matter, the investigator shall delay submission for up to an additional 90 calendar days beyond the initial 60-day review period to permit Penterra to file appropriate patent applications.
•  Multi-center publications shall take priority over single-site publications.
Tab 12 — Exhibit H: Regulatory Compliance Representations and Covenants
•  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 Investigators
•  21 C.F.R. Part 56 — Institutional Review Boards
•  21 C.F.R. Part 312 — Investigational New Drug Application
•  ICH E6(R2) — Guideline for Good Clinical Practice (GCP)
•  Federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b))
•  Physician Payments Sunshine Act / Open Payments (42 U.S.C. § 1320a-7h) — All payments and transfers of value to investigators shall be reported in accordance with the Open Payments program administered by the Centers for Medicare & Medicaid Services (CMS).
•  Fair Market Value Representations — All compensation payable to investigators under the MCTA and any Individual Site Agreement has been determined to be consistent with fair market value for the services rendered, based on a fair market value assessment conducted by an independent third-party valuation firm.
Tab 13 — Exhibit I: Form of Investigator Undertaking
•  Compliance with Protocol PPC-4871-III (CLARION), including all amendments approved by the Sponsor and the applicable IRB;
•  Compliance with Good Clinical Practice (GCP) as set forth in ICH E6(R2) and applicable FDA regulations;
•  Compliance with all applicable federal, state, and local regulations governing the conduct of clinical trials;
•  Completion of financial disclosure obligations pursuant to 21 C.F.R. Part 54, including the submission of FDA Form 3455 (Disclosure: Financial Interests and Arrangements of Clinical Investigators) and FDA Form 3454 (Certification: Financial Interests and Arrangements of Clinical Investigators);
•  Compliance with the confidentiality provisions set forth in the MCTA and Exhibit F thereto;
•  Acknowledgment of Penterra's exclusive ownership of all clinical trial data generated in connection with the CLARION trial; and
•  Agreement to cooperate with Sponsor-initiated audits and regulatory inspections.
Tab 14 — Exhibit J: Safety Reporting Procedures
(a) Serious Adverse Event (SAE) Reporting Timeline:
Each site shall report all serious adverse events to the Sponsor and to Meridian Contract Research Organization, Inc. (the designated CRO for safety data management) within 24 hours of the site becoming aware of the event. Reports shall be submitted via the Pinnacle Data Solutions EDC platform and confirmed by facsimile or email to the Penterra Pharmacovigilance Department.
(b) IND Safety Report Obligations:
•  Fatal or Life-Threatening Events: The Sponsor shall submit IND safety reports to the FDA within 7 calendar days of initial receipt of information for any unexpected fatal or life-threatening suspected adverse reaction.
•  All Other IND Safety Reports: The Sponsor shall submit IND safety reports within 15 calendar days for all other events meeting the criteria for expedited reporting under 21 C.F.R. § 312.32.
(c) CRO Coordination:
Meridian Contract Research Organization, Inc. shall serve as the central coordinator for safety data management, including the receipt, processing, assessment, and tracking of all SAE reports from participating sites. Meridian shall maintain a global safety database for the CLARION trial and shall provide periodic safety reports to the Sponsor.
(d) Site Expedited Reporting Responsibilities:
Each site shall maintain a local safety reporting process to ensure timely identification, documentation, and reporting of all adverse events, serious adverse events, and suspected unexpected serious adverse reactions (SUSARs). Sites shall designate a qualified safety reporting contact and shall ensure that site personnel are trained on the safety reporting procedures set forth in this Exhibit J.
Tab 15 — Exhibit K: Approved Subcontractors List
Each subcontractor listed above has entered into, or will enter into, a separate services agreement with the Sponsor and/or the Site Network, as applicable. All subcontractors are subject to the confidentiality, data protection, and regulatory compliance obligations set forth in the MCTA.
VOLUME III — SCHEDULE
Volume III contains the schedule to the Master Clinical Trial Agreement identifying all participating Veridian Network sites.
Tab 16 — Schedule 1: List of Participating Veridian Network Sites (38 Sites)
Lead Sites:
The remaining 36 sites, with their respective site numbers, institution names, addresses, principal investigators, IRBs of record, and planned enrollment allocations, are set forth in the complete Schedule 1 document behind this tab. Total planned enrollment across all 38 sites is 1,200 subjects.
VOLUME IV — INDIVIDUAL SITE AGREEMENTS (REPRESENTATIVE JOINDERS)
Volume IV contains executed Individual Site Agreements (joinders) for the first five representative participating Veridian Network sites (Sites 001 through 005). Additional joinder agreements will be executed on a rolling basis as sites complete the activation process and will be added to this volume as supplemental tabs.
Tab 17 — Individual Site Agreement: Graystone University Medical Center (Site 001)
Tab 18 — Individual Site Agreement: Lakemont Medical Center (Site 002)
Tab 19 — Individual Site Agreement: Haverford Regional Medical Center (Site 003)
Tab 20 — Individual Site Agreement: Cedar Falls University Hospital (Site 004)
Tab 21 — Individual Site Agreement: Weston Memorial Health System (Site 005)
VOLUME V — INVESTIGATOR AGREEMENTS
Volume V contains the executed investigator agreements for the Global Principal Investigator and the Co-Principal Investigator for the CLARION trial. These agreements set forth the individual obligations, compensation terms, regulatory responsibilities, and publication rights applicable to the named investigators.
Tab 22 — Principal Investigator Agreement: Dr. Catherine Aldridge, M.D., Ph.D.
Tab 23 — Co-Principal Investigator Agreement: Dr. Howard Matsuoka, M.D.
VOLUME VI — ANCILLARY AGREEMENTS
Volume VI contains the ancillary agreements executed in connection with the MCTA.
Tab 24 — Intellectual Property Side Letter (Execution Version)
VOLUME VII — CLOSING CERTIFICATES AND CORPORATE AUTHORIZATION DOCUMENTS
Volume VII contains all closing certificates, secretary's certificates, and officer's certificates delivered by the parties at or prior to the closing date of July 5, 2023, as conditions precedent to the effectiveness of the MCTA.
Tab 25 — Closing Certificate: Penterra Pharmaceuticals Corp.
Tab 26 — Closing Certificate: Veridian Health Research Network, Inc.
Tab 27 — Secretary's Certificate: Penterra Pharmaceuticals Corp.
Tab 28 — Secretary's Certificate: Veridian Health Research Network, Inc.
Tab 29 — Officer's Certificate: Penterra Pharmaceuticals Corp. (Representations and Warranties Bringdown)
VOLUME VIII — INSURANCE DOCUMENTS
Volume VIII contains all insurance-related documents delivered in connection with the MCTA, including certificates of insurance, transmittal letters, requests for additional insured endorsements, and site insurance certificate tracking materials.
Tab 30 — Certificate of Insurance: Penterra Pharmaceuticals Corp. (Briarcliff Mutual)
Tab 31 — Certificate of Insurance Transmittal Letter: Penterra to Veridian
Tab 32 — Letter to Briarcliff Mutual: Request for Additional Insured Endorsement
Tab 33 — Letter to Veridian: Request for Site Insurance Certificates
Tab 34 — Site Insurance Certificates (as received)
VOLUME IX — IRB APPROVALS (LEAD SITES)
Volume IX contains the IRB approval documentation for the lead sites in the CLARION trial. IRB approval for the lead sites was a condition precedent to closing under the MCTA.
Tab 35 — IRB Approval: Graystone University Institutional Review Board
Tab 36 — IRB Approval: Veridian Central IRB (Lakemont Medical Center and Network Sites)
VOLUME X — CONDITIONS PRECEDENT SATISFACTION
Volume X contains the internal memoranda and closing checklists documenting the satisfaction of all conditions precedent to the closing of the MCTA.
Tab 37 — Conditions Precedent Satisfaction Memorandum
(i) Delivery of Insurance Certificates (Tabs 30–34): Penterra's certificate of insurance from Briarcliff Mutual Insurance Company has been delivered and confirms coverage meeting the requirements of Exhibit E. Site insurance certificates are being collected on a rolling basis, with certificates from Sites 001 through 005 received as of the closing date.
(ii) IRB Approvals for Lead Sites (Tabs 35–36): IRB approval from the Graystone University Institutional Review Board (for Site 001) and central IRB approval from the Veridian Central IRB (for Site 002 and remaining network sites) have been received and are in full force and effect.
(iii) Executed Investigator Signature Pages (Tabs 22–23): The Principal Investigator Agreement with Dr. Catherine Aldridge, M.D., Ph.D., and the Co-Principal Investigator Agreement with Dr. Howard Matsuoka, M.D., have been fully executed.
(iv) Execution of All Ancillary Agreements (Tab 24): The intellectual Property Side Letter has been executed concurrently with the MCTA.
(v) Delivery of Corporate Authorization Documents (Tabs 27–29): Secretary's certificates from both Penterra and Veridian, together with the Officer's Certificate (representations and warranties bringdown) from Penterra, have been delivered and are in proper form.
Tab 38 — Closing Checklist
VOLUME XI — CORRESPONDENCE
Volume XI contains key correspondence generated during the negotiation, drafting, execution, and closing of the MCTA and ancillary agreements, organized chronologically. This volume is included to provide a complete record of the transaction history and to document the key decisions and compromises reached during the negotiation process.
Tab 39 — Engagement Kick-Off Email
Tab 40 — Transmittal Letter: First Draft MCTA
Tab 41 — Email: Indemnification Issues Follow-Up
Tab 42 — Transmittal Letter: Second Draft MCTA
Tab 43 — Publication Rights Negotiation Correspondence
Tab 44 — Email: Scheduling In-Person Negotiation Session
Tab 45 — Email: Post-Negotiation Session Client Update
Tab 46 — Transmittal Letter: Near-Final Draft MCTA
Tab 47 — Matter Closing Confirmation Letter
VOLUME XII — DRAFT HISTORY (REFERENCE COPIES)
Volume XII contains reference copies of all major drafts, redlines, and negotiation documents generated during the drafting and negotiation of the MCTA. These documents are included for reference purposes only and do not form part of the executed transaction documents.
Tab 48 — First Draft MCTA
Tab 49 — Second Draft MCTA
Tab 50 — Redline: Second Draft Against First Draft
Tab 51 — Near-Final Draft MCTA
Tab 52 — Final Agreed Draft MCTA
Tab 53 — Redline: Final Draft Against Near-Final Draft
Tab 54 — Indemnification Term Sheet
VOLUME XIII — KEY REFERENCE DOCUMENTS (NOT PART OF TRANSACTION; INCLUDED FOR REFERENCE)
Volume XIII contains key reference documents that are not part of the executed transaction documents but are included in the closing binder for informational and reference purposes. These documents provide context for the engagement, the professional relationship between Calderwood & Harkness LLP and Penterra Pharmaceuticals Corp., and the post-closing obligations of the parties.
Tab 55 — Engagement Letter: Calderwood & Harkness LLP to Penterra Pharmaceuticals Corp.
Tab 56 — Retainer Agreement Acknowledgment Letter
Tab 57 — Closing Memorandum (Post-Closing Summary)
(a) Annual Insurance Renewals: Penterra's clinical trial liability insurance policy (Briarcliff Mutual, Policy No. BM-CTL-2023-04182) is subject to annual renewal. The first renewal date is March 31, 2024. Penterra must provide updated certificates of insurance to Veridian within 15 business days of each renewal.
(b) Remaining Site Joinder Executions: As of the effective date, executed Individual Site Agreements (joinders) have been received from Sites 001 through 005. Joinder agreements for the remaining 33 sites (Sites 006 through 038) will be executed on a rolling basis as sites complete the activation process.
(c) Key Milestone Dates:
•  Target First Patient In (FPI): August 14, 2023
•  Projected Last Patient In (LPI): February 2027 (42-month enrollment period)
•  Projected Study Completion: August 2028 (60-month total study duration)
APPENDIX — KEY CONTACT INFORMATION
The following table sets forth the key contact information for each party, outside counsel, and key service providers in connection with the Master Clinical Trial Agreement for Protocol PPC-4871-III (CLARION).
Penterra Pharmaceuticals Corp. 200 Biopharma Boulevard, Suite 1400, Princeton, NJ 08540
Veridian Health Research Network, Inc. 750 Research Parkway, 8th Floor, Philadelphia, PA 19104
Calderwood & Harkness LLP (Counsel for Penterra Pharmaceuticals Corp.) 280 Park Avenue, 34th Floor, New York, NY 10017 101 Carnegie Center, Suite 500, Princeton, NJ 08540
Whitmore, Jansen & Callahan LLP (Counsel for Veridian Health Research Network, Inc.) 1500 Market Street, Suite 3200, Philadelphia, PA 19102
Briarcliff Mutual Insurance Company 55 Constitution Plaza, Hartford, CT 06103
Meridian Contract Research Organization, Inc. 9200 Corporate Boulevard, Raleigh, NC 27615
Pinnacle Data Solutions, Inc. 6000 Clearwater Drive, San Diego, CA 92121
Northbridge Bioanalytical Laboratories, Inc. 2900 Commerce Way, Baltimore, MD 21224
Castleton & Hargrove LLP (Regulatory Counsel) 1100 Connecticut Avenue NW, Suite 900, Washington, DC 20036
CERTIFICATION
This Closing Binder Index and Table of Contents was prepared by Calderwood & Harkness LLP and is current as of July 18, 2023. Volumes I through XIII contain fifty-seven (57) tabs representing all material documents, certificates, and deliverables relating to the Master Clinical Trial Agreement between Penterra Pharmaceuticals Corp. and Veridian Health Research Network, Inc. dated June 28, 2023 (effective July 18, 2023).
Matter Number: 1018-00004
Prepared by:
________________________________________
Christopher Aiken Associate Calderwood & Harkness LLP 280 Park Avenue, 34th Floor New York, NY 10017
Reviewed by:
________________________________________
Sean Morrissey Associate Calderwood & Harkness LLP
________________________________________
Miriam Calloway Partner Calderwood & Harkness LLP
CONFIDENTIAL — This document and the closing binder to which it relates contain confidential and proprietary information of the parties and are subject to applicable confidentiality obligations. Distribution is limited to authorized recipients only. Attorney work product and attorney-client privileged materials may be included in certain volumes. Unauthorized reproduction or distribution is prohibited.
Field | Detail
Document | Master Clinical Trial Agreement between Penterra Pharmaceuticals Corp. and Veridian Health Research Network, Inc.
Date | June 28, 2023
Sponsor | Penterra Pharmaceuticals Corp., 200 Biopharma Boulevard, Suite 1400, Princeton, NJ 08540
Site Network | Veridian Health Research Network, Inc., 750 Research Parkway, 8th Floor, Philadelphia, PA 19104
Governing Law | State of New York
Description | Fully executed Master Clinical Trial Agreement for Protocol PPC-4871-III (CLARION — Clinical Assessment of Response with Longitudinal Investigation in ONcology), a Phase III, randomized, double-blind, placebo-controlled study of penterafenib (PPC-4871) in advanced hepatocellular carcinoma (HCC). The MCTA governs the relationship between the Sponsor and the Site Network for the conduct of the CLARION trial across 38 Veridian Network sites located in 14 states. The agreement covers site fees, per-patient payments, investigator grants, network coordination fees, technology and electronic data capture integration costs, and operational costs totaling $80,000,000 across the projected 60-month study duration. The MCTA sets forth the parties' respective obligations relating to regulatory compliance, safety reporting, indemnification, insurance, intellectual property, data ownership, publication rights, and confidentiality.
Field | Detail
Document | Executed Signature Page — Penterra Pharmaceuticals Corp.
Signatory | Nathaniel Briggs, Esq., Vice President and General Counsel, Penterra Pharmaceuticals Corp.
Date of Execution | June 28, 2023
Description | Original executed signature page of Penterra Pharmaceuticals Corp. to the Master Clinical Trial Agreement, bearing the manual signature of Nathaniel Briggs, Esq., in his capacity as Vice President and General Counsel, duly authorized to execute the MCTA on behalf of Penterra pursuant to the board resolutions certified in Tab 27.
Field | Detail
Document | Executed Signature Page — Veridian Health Research Network, Inc.
Signatory | Dr. Franklin Osei, M.D., Ph.D., President and Chief Executive Officer, Veridian Health Research Network, Inc.
Date of Execution | June 28, 2023
Description | Original executed signature page of Veridian Health Research Network, Inc. to the Master Clinical Trial Agreement, bearing the manual signature of Dr. Franklin Osei, M.D., Ph.D., in his capacity as President and Chief Executive Officer, duly authorized to execute the MCTA on behalf of Veridian pursuant to the board resolutions certified in Tab 28.
Field | Detail
Document | Executed Signature Page — Graystone University Medical Center
Signatory | Dr. William Corwin, M.D., President, Graystone University Medical Center
Date of Execution | June 28, 2023
Address | 1200 University Avenue, Philadelphia, PA 19104
Description | Original executed signature page of Graystone University Medical Center, the designated lead site for the CLARION trial (Site 001), to the Master Clinical Trial Agreement, bearing the manual signature of Dr. William Corwin, M.D., in his capacity as President of Graystone University Medical Center. Graystone is a signatory to the MCTA in its capacity as the lead investigational site within the Veridian Network, and its signature page is included with the principal transaction agreement rather than solely as a joinder site agreement.
Field | Detail
Document | Protocol Synopsis for Protocol PPC-4871-III (CLARION — Clinical Assessment of Response with Longitudinal Investigation in ONcology)
Study Design | Phase III, randomized, double-blind, placebo-controlled
Investigational Product | Penterafenib (PPC-4871)
Indication | Advanced hepatocellular carcinoma (HCC)
Planned Enrollment | 1,200 subjects (2:1 randomization — 800 treatment arm : 400 placebo arm)
Primary Endpoint | Overall survival (OS)
Key Secondary Endpoints | Progression-free survival (PFS); objective response rate (ORR); duration of response (DOR)
Enrollment Period | 42 months
Total Study Duration | 60 months
IND Number | 157823
ClinicalTrials.gov Identifier | NCT05928174
Target First Patient In (FPI) | August 14, 2023
Description | The Protocol Synopsis sets forth the key design parameters, eligibility criteria, dosing schedule, assessment schedule, statistical analysis plan overview, and study schema for the CLARION trial. The Protocol Synopsis is attached to the MCTA as Exhibit A and governs the conduct of the study at all 38 participating Veridian Network sites. The full Protocol (Version 3.0, dated March 15, 2023) is maintained on file with the Sponsor and is available to each site through the Pinnacle Data Solutions electronic trial master file system.
Field | Detail
Document | Budget and Milestone Payment Schedule
Total Budget | $80,000,000
Description | Itemized budget and payment schedule for all costs associated with the conduct of the CLARION trial across all 38 Veridian Network sites. The budget is organized by category as follows:
Category | Calculation | Amount
Per-Patient Site Fees | $52,000/subject × 1,200 subjects | $62,400,000
Start-Up Fees | $75,000/site × 38 sites | $2,850,000
Annual Site Maintenance Fees | $40,000/site × 38 sites × 3.5 avg. years | $5,320,000
Investigator Grants | Lump sum | $1,500,000
Network Coordination Fee | $300,000/quarter × 14 quarters | $4,200,000
Technology / EDC Integration | Lump sum | $1,230,000
Contingency Reserve | Lump sum | $2,500,000
TOTAL | $80,000,000
Field | Detail
Document | Template Form of Individual Site Agreement (Joinder) for Veridian Network Participating Sites
Description | The form of Individual Site Agreement (also referred to as the "Joinder" or "Site Joinder Agreement") is a standardized template agreement to be executed by each Veridian Network site that participates in the CLARION trial. The form incorporates all terms of the MCTA by reference and supplements those terms with site-specific schedules, including: (a) identification of the principal investigator and sub-investigators at such site; (b) the site-specific budget allocation derived from the master budget set forth in Exhibit B; (c) the Institutional Review Board (IRB) of record for such site; (d) site-specific regulatory and compliance information; and (e) the planned enrollment allocation for such site. The executed joinder agreements for the first five representative sites (Sites 001 through 005) are included in Volume IV of this closing binder. Additional joinder agreements will be executed on a rolling basis as sites are activated throughout the enrollment period.
Field | Detail
Document | Detailed Indemnification Provisions for Subject Injury and Related Claims
Description | The indemnification provisions set forth in Exhibit D allocate responsibility between the Sponsor, the Site Network, and individual participating sites for claims arising from injuries sustained by clinical trial subjects enrolled in the CLARION trial. The key terms of the indemnification framework are as follows:
Field | Detail
Document | Insurance Requirements and Certificate Forms
Description | Exhibit E sets forth the minimum insurance requirements applicable to the Sponsor, the Site Network, and each participating site for the duration of the CLARION trial, together with the prescribed forms for certificates of insurance and additional insured endorsements. The key insurance requirements are as follows:
Field | Detail
Document | Confidentiality and Data Protection Exhibit
Confidentiality Term | 10 years from the date of disclosure of the applicable Confidential Information
Description | Exhibit F establishes the confidentiality framework applicable to all parties to the MCTA. The scope of Confidential Information covers all protocol-related information, investigational product specifications (including manufacturing processes, formulations, and analytical data), clinical study data (including subject-level data), financial terms of the MCTA and any Individual Site Agreement, regulatory submissions and correspondence, and any other proprietary or non-public information disclosed by one party to another in connection with the CLARION trial.
Field | Detail
Document | Intellectual Property and Publication Rights Exhibit
Description | Exhibit G governs the ownership of intellectual property arising during the conduct of the CLARION trial and establishes the framework for investigator publications. The key provisions are as follows:
Field | Detail
Document | Regulatory Compliance Representations and Covenants
Description | Exhibit H sets forth the representations and ongoing covenants of the Sponsor, the Site Network, and each participating site with respect to compliance with applicable regulatory requirements governing the conduct of the CLARION trial. The parties represent and covenant that the study will be conducted in compliance with the following:
Field | Detail
Document | Template Form of Investigator Undertaking
Description | The Form of Investigator Undertaking is a standardized template to be executed by each principal investigator and sub-investigator at every participating Veridian Network site prior to the initiation of study activities at such site. By executing the Investigator Undertaking, each investigator confirms and agrees to the following:
Field | Detail
Document | Safety Reporting Procedures
Description | Exhibit J establishes the safety reporting obligations of each participating site, the Site Network, and the Sponsor in connection with the CLARION trial. The safety reporting framework is designed to ensure compliance with applicable FDA regulations (21 C.F.R. § 312.32) and ICH E6(R2) requirements. The key provisions are as follows:
Field | Detail
Document | Approved Subcontractors and Third-Party Service Providers
Description | Exhibit K identifies the subcontractors and third-party service providers approved by both Penterra and Veridian for the performance of specified services in connection with the CLARION trial. The approved subcontractors are as follows:
Subcontractor | Role | Address
Meridian Contract Research Organization, Inc. | Contract Research Organization (CRO) — clinical monitoring, data management, safety data management, regulatory submissions support | 9200 Corporate Boulevard, Raleigh, NC 27615
Pinnacle Data Solutions, Inc. | Electronic Data Capture (EDC) platform provider — eCRF design, data hosting, EDC system administration and support | 6000 Clearwater Drive, San Diego, CA 92121
Northbridge Bioanalytical Laboratories, Inc. | Central laboratory — sample analysis, biomarker assays, pharmacokinetic sample analysis, central pathology review | 2900 Commerce Way, Baltimore, MD 21224
Field | Detail
Document | Schedule 1 — List of Participating Veridian Network Sites
Number of Sites | 38
Number of States | 14
Description | Schedule 1 sets forth a comprehensive list of all 38 Veridian Health Research Network sites that have been approved to participate in the CLARION trial. The schedule is organized by site number and includes the following information for each site: (a) site number; (b) institution name; (c) address; (d) principal investigator; (e) IRB of record; and (f) planned enrollment allocation.
Site No. | Institution | City, State | Principal Investigator | IRB of Record | Planned Enrollment
001 | Graystone University Medical Center | Philadelphia, PA | Dr. Catherine Aldridge, M.D., Ph.D. | Graystone University Institutional Review Board (IRB00012847) | 80 subjects
002 | Lakemont Medical Center | Chicago, IL | Dr. Howard Matsuoka, M.D. (Co-PI) | Veridian Central IRB | 60 subjects
Field | Detail
Document | Executed Individual Site Agreement (Joinder) — Graystone University Medical Center
Site Number | 001
Address | 1200 University Avenue, Philadelphia, PA 19104
Principal Investigator | Dr. Catherine Aldridge, M.D., Ph.D.
IRB of Record | Graystone University Institutional Review Board (IRB Registration: IRB00012847)
Signatory | Dr. William Corwin, M.D., President, Graystone University Medical Center
Description | Executed joinder agreement pursuant to which Graystone University Medical Center agrees to participate in the CLARION trial as Site 001, the lead investigational site, on the terms and conditions set forth in the MCTA and the site-specific schedules annexed to the joinder. The joinder incorporates the MCTA by reference and includes site-specific schedules identifying the principal investigator and sub-investigators, the site-specific budget allocation, and regulatory and compliance information.
Field | Detail
Document | Executed Individual Site Agreement (Joinder) — Lakemont Medical Center
Site Number | 002
Address | 4400 North Michigan Drive, Chicago, IL 60611
Co-Principal Investigator | Dr. Howard Matsuoka, M.D.
IRB of Record | Veridian Central IRB
Description | Executed joinder agreement pursuant to which Lakemont Medical Center agrees to participate in the CLARION trial as Site 002 on the terms and conditions set forth in the MCTA and the site-specific schedules annexed to the joinder. Lakemont Medical Center serves as the co-lead site for the study and operates under the oversight of the Veridian Central IRB.
Field | Detail
Document | Executed Individual Site Agreement (Joinder) — Haverford Regional Medical Center
Site Number | 003
Location | Boston, MA
IRB of Record | Veridian Central IRB
Description | Executed joinder agreement pursuant to which Haverford Regional Medical Center agrees to participate in the CLARION trial as Site 003 on the terms and conditions set forth in the MCTA and the site-specific schedules annexed to the joinder. Haverford Regional Medical Center operates under the oversight of the Veridian Central IRB.
Field | Detail
Document | Executed Individual Site Agreement (Joinder) — Cedar Falls University Hospital
Site Number | 004
Location | Denver, CO
IRB of Record | Veridian Central IRB
Description | Executed joinder agreement pursuant to which Cedar Falls University Hospital agrees to participate in the CLARION trial as Site 004 on the terms and conditions set forth in the MCTA and the site-specific schedules annexed to the joinder. Cedar Falls University Hospital operates under the oversight of the Veridian Central IRB.
Field | Detail
Document | Executed Individual Site Agreement (Joinder) — Weston Memorial Health System
Site Number | 005
Location | Atlanta, GA
IRB of Record | Veridian Central IRB
Description | Executed joinder agreement pursuant to which Weston Memorial Health System agrees to participate in the CLARION trial as Site 005 on the terms and conditions set forth in the MCTA and the site-specific schedules annexed to the joinder. Weston Memorial Health System operates under the oversight of the Veridian Central IRB.
Field | Detail
Document | Principal Investigator Agreement between Penterra Pharmaceuticals Corp. and Dr. Catherine Aldridge, M.D., Ph.D.
Role | Global Principal Investigator for Protocol PPC-4871-III (CLARION)
Institutional Affiliation | Graystone University Medical Center, 1200 University Avenue, Philadelphia, PA 19104
Description | This agreement establishes the terms and conditions of Dr. Aldridge's engagement as the Global Principal Investigator for the CLARION trial. The agreement addresses: (a) Dr. Aldridge's regulatory obligations as the principal investigator under 21 C.F.R. Part 312, including responsibility for the overall conduct of the study at the lead site and oversight coordination across all Veridian Network sites; (b) publication rights, consistent with the framework set forth in Exhibit G to the MCTA; (c) financial disclosure obligations under 21 C.F.R. Part 54, including the submission of completed FDA Forms 3454 and 3455; and (d) compensation terms, which have been determined to be consistent with fair market value for the services rendered based on an independent third-party valuation assessment. All payments to Dr. Aldridge are reportable under the Physician Payments Sunshine Act / Open Payments program.
Field | Detail
Document | Co-Principal Investigator Agreement between Penterra Pharmaceuticals Corp. and Dr. Howard Matsuoka, M.D.
Role | Co-Principal Investigator at Lakemont Medical Center (Site 002)
Institutional Affiliation | Lakemont Medical Center, 4400 North Michigan Drive, Chicago, IL 60611
Description | This agreement establishes the terms and conditions of Dr. Matsuoka's engagement as a Co-Principal Investigator for the CLARION trial at Lakemont Medical Center. The agreement addresses: (a) Dr. Matsuoka's regulatory obligations under 21 C.F.R. Part 312; (b) publication rights, consistent with the framework set forth in Exhibit G to the MCTA; (c) financial disclosure obligations under 21 C.F.R. Part 54; and (d) compensation terms, determined to be consistent with fair market value. All payments to Dr. Matsuoka are reportable under the Physician Payments Sunshine Act / Open Payments program.
Field | Detail
Document | Intellectual Property Side Letter between Penterra Pharmaceuticals Corp. and Veridian Health Research Network, Inc.
Date | June 28, 2023 (executed concurrently with the MCTA)
Parties | Penterra Pharmaceuticals Corp. and Veridian Health Research Network, Inc.
Description | The IP Side Letter supplements the intellectual property provisions set forth in Exhibit G to the MCTA and establishes a detailed framework governing the ownership, licensing, and exploitation of inventions arising during the conduct of the CLARION trial. The key provisions include: (a) confirmation that each party retains all right, title, and interest in and to its pre-existing intellectual property; (b) allocation of ownership rights in joint inventions (i.e., inventions conceived or first reduced to practice jointly by personnel of Penterra and personnel of a Veridian Network site), including provisions for joint ownership with exclusive licensing rights to the Sponsor for clinical and commercial exploitation; (c) procedures for the identification, evaluation, and reporting of potentially patentable inventions; (d) patent prosecution procedures, including the allocation of prosecution responsibility and costs; and (e) provisions governing the resolution of disputes relating to inventorship and ownership. The IP Side Letter was executed concurrently with the MCTA and is cross-referenced in Section 12.3 of the MCTA and in Exhibit G.
Field | Detail
Document | Closing Certificate — Penterra Pharmaceuticals Corp.
Signatory | Nathaniel Briggs, Esq., Vice President and General Counsel
Date | July 5, 2023
Description | Closing certificate executed by Nathaniel Briggs, Esq., on behalf of Penterra Pharmaceuticals Corp., certifying that: (i) all representations and warranties made by Penterra in the MCTA are true and correct in all material respects as of the closing date (July 5, 2023), with the same force and effect as though such representations and warranties had been made on and as of the closing date; (ii) Penterra has performed and complied in all material respects with all covenants and obligations required to be performed or complied with by Penterra prior to or on the closing date; and (iii) no event has occurred that would constitute a material breach of the MCTA or give rise to a termination right thereunder.
Field | Detail
Document | Closing Certificate — Veridian Health Research Network, Inc.
Signatory | Dr. Franklin Osei, M.D., Ph.D., President and Chief Executive Officer
Date | July 5, 2023
Description | Closing certificate executed by Dr. Franklin Osei, M.D., Ph.D., on behalf of Veridian Health Research Network, Inc., certifying that: (i) all representations and warranties made by Veridian in the MCTA are true and correct in all material respects as of the closing date (July 5, 2023), with the same force and effect as though such representations and warranties had been made on and as of the closing date; (ii) Veridian has performed and complied in all material respects with all covenants and obligations required to be performed or complied with by Veridian prior to or on the closing date; and (iii) no event has occurred that would constitute a material breach of the MCTA or give rise to a termination right thereunder.
Field | Detail
Document | Secretary's Certificate — Penterra Pharmaceuticals Corp.
Date | July 5, 2023
Description | Certificate of the Secretary (or Assistant Secretary) of Penterra Pharmaceuticals Corp. certifying: (a) true and correct copies of the resolutions duly adopted by the Board of Directors of Penterra authorizing the execution, delivery, and performance of the MCTA and all ancillary agreements contemplated thereby; (b) the incumbency and specimen signatures of all authorized signatories of Penterra, including Nathaniel Briggs, Esq. (Vice President and General Counsel) and Dr. Anand Raghavan, M.D., Ph.D. (Chief Medical Officer); and (c) attached copies of the current bylaws and certificate of incorporation of Penterra Pharmaceuticals Corp. Penterra is a corporation organized and existing under the laws of the State of Delaware.
Field | Detail
Document | Secretary's Certificate — Veridian Health Research Network, Inc.
Date | July 5, 2023
Description | Certificate of the Secretary (or Assistant Secretary) of Veridian Health Research Network, Inc. certifying: (a) true and correct copies of the resolutions duly adopted by the Board of Directors of Veridian authorizing the execution, delivery, and performance of the MCTA and all ancillary agreements contemplated thereby; (b) the incumbency and specimen signatures of all authorized signatories of Veridian, including Dr. Franklin Osei, M.D., Ph.D. (President and Chief Executive Officer) and Gregory Callahan, Esq. (Vice President, Legal and Compliance); and (c) attached copies of the relevant organizational documents of Veridian Health Research Network, Inc. Veridian is a Delaware 501(c)(3) not-for-profit corporation (EIN: 23-4178205).
Field | Detail
Document | Officer's Certificate — Representations and Warranties Bringdown — Penterra Pharmaceuticals Corp.
Date | July 5, 2023
Description | Officer's certificate executed by a duly authorized officer of Penterra Pharmaceuticals Corp. confirming that all representations and warranties of Penterra set forth in the MCTA (including, without limitation, the representations and warranties contained in Sections 7.1 through 7.15 thereof) are true and correct in all material respects as of the closing date (July 5, 2023), as though made on and as of such date (except to the extent that any such representation or warranty expressly relates to a specific earlier date, in which case such representation or warranty shall be true and correct in all material respects as of such earlier date). This certificate was delivered as a condition precedent to the closing of the transactions contemplated by the MCTA.
Field | Detail
Document | Certificate of Insurance — Penterra Pharmaceuticals Corp.
Insurer | Briarcliff Mutual Insurance Company, 55 Constitution Plaza, Hartford, CT 06103
Insured | Penterra Pharmaceuticals Corp.
Policy Number | BM-CTL-2023-04182
Policy Period | April 1, 2023 through March 31, 2024 (renewable annually)
Coverage Type | Clinical Trial Liability Insurance
Limits of Liability | $25,000,000 per occurrence / $75,000,000 in the aggregate
Subject-Injury Sublimit | $10,000,000 per occurrence / $50,000,000 in the aggregate
Additional Insureds | Veridian Health Research Network, Inc. and each participating Veridian Network site identified in Schedule 1 to the MCTA
Underwriter Contact | Karen Tremblay, Vice President, Life Sciences Lines, Briarcliff Mutual Insurance Company
Description | Certificate of insurance issued by Briarcliff Mutual Insurance Company evidencing that Penterra Pharmaceuticals Corp. maintains clinical trial liability insurance with the limits and coverages required by Exhibit E to the MCTA. The certificate confirms that Veridian Health Research Network, Inc. and each participating Veridian Network site have been named as additional insureds under the policy. Delivery of this certificate was a condition precedent to closing under the MCTA.
Field | Detail
Document | Transmittal Letter — Certificate of Insurance
From | Calderwood & Harkness LLP (on behalf of Penterra Pharmaceuticals Corp.)
To | Whitmore, Jansen & Callahan LLP (counsel for Veridian Health Research Network, Inc.)
Description | Transmittal letter from Calderwood & Harkness LLP to Whitmore, Jansen & Callahan LLP enclosing Penterra's certificate of insurance from Briarcliff Mutual Insurance Company (Policy No. BM-CTL-2023-04182) and confirming that the certificate evidences the coverage and additional insured status required by Exhibit E to the MCTA. The letter requests written acknowledgment of receipt from Veridian's counsel.
Field | Detail
Document | Letter Requesting Additional Insured Endorsement
From | Calderwood & Harkness LLP (on behalf of Penterra Pharmaceuticals Corp.)
To | Karen Tremblay, Vice President, Life Sciences Lines, Briarcliff Mutual Insurance Company, 55 Constitution Plaza, Hartford, CT 06103
Description | Formal letter from Calderwood & Harkness LLP, acting on behalf of Penterra Pharmaceuticals Corp., requesting that Briarcliff Mutual Insurance Company endorse Policy No. BM-CTL-2023-04182 to name Veridian Health Research Network, Inc. and each Veridian Network site participating in the CLARION trial (as identified in Schedule 1 to the MCTA) as additional insureds under the policy. The letter encloses a copy of the relevant provisions of Exhibit E to the MCTA and Schedule 1 identifying the 38 participating sites.
Field | Detail
Document | Letter Requesting Site Insurance Certificates
From | Calderwood & Harkness LLP
To | Gregory Callahan, Esq., Vice President, Legal and Compliance, Veridian Health Research Network, Inc.
Description | Letter from Calderwood & Harkness LLP to Gregory Callahan, Esq., Vice President, Legal and Compliance at Veridian Health Research Network, Inc., requesting that Veridian provide certificates of insurance from each of the 38 participating Veridian Network sites demonstrating that each site maintains general liability and professional liability insurance with limits of at least $5,000,000 per occurrence and $10,000,000 in the aggregate, as required by Exhibit E to the MCTA. The letter notes that such certificates are due within 15 business days of execution of the MCTA (i.e., by July 21, 2023), and requests that certificates be transmitted to Calderwood & Harkness LLP as they are received.
Field | Detail
Document | Certificates of Insurance — Veridian Network Participating Sites
Description | This tab serves as a placeholder for certificates of insurance received from participating Veridian Network sites demonstrating compliance with the insurance requirements set forth in Exhibit E to the MCTA. Certificates are being collected by Veridian Health Research Network, Inc. from each of the 38 participating sites and will be transmitted to Calderwood & Harkness LLP on a rolling basis as they are received. The status of certificate receipt will be tracked in the insurance certificate tracking spreadsheet maintained by Calderwood & Harkness LLP and will be updated periodically. As of the date of binder assembly (July 18, 2023), certificates have been received from Sites 001 through 005. Certificates from the remaining 33 sites are expected to be received by July 21, 2023.
Field | Detail
Document | IRB Approval Letter — Protocol PPC-4871-III (CLARION)
IRB | Graystone University Institutional Review Board (IRB Registration: IRB00012847)
Institution | Graystone University Medical Center (Site 001), 1200 University Avenue, Philadelphia, PA 19104
Description | Original IRB approval letter from the Graystone University Institutional Review Board granting approval for the conduct of the CLARION trial (Protocol PPC-4871-III, Version 3.0, dated March 15, 2023) at Graystone University Medical Center. The approval letter confirms that the IRB has reviewed and approved the protocol, the informed consent documents, the investigator's brochure, and all recruitment materials. The Graystone University IRB serves as the IRB of record for Site 001 (Graystone University Medical Center). Receipt of this IRB approval was a condition precedent to closing under Section 6.1(b)(i) of the MCTA.
Field | Detail
Document | Central IRB Approval Letter / Authorization — Protocol PPC-4871-III (CLARION)
IRB | Veridian Central IRB
Covered Sites | Lakemont Medical Center (Site 002) and remaining non-Pennsylvania Veridian Network sites operating under IRB Authorization Agreements with the Veridian Central IRB
Description | Original IRB approval letter and central IRB authorization from the Veridian Central IRB granting approval for the conduct of the CLARION trial (Protocol PPC-4871-III, Version 3.0, dated March 15, 2023) at Lakemont Medical Center and all other Veridian Network sites that have entered into IRB Authorization Agreements designating the Veridian Central IRB as the IRB of record. The approval covers the protocol, informed consent documents, investigator's brochure, and recruitment materials. The Veridian Central IRB serves as the reviewing IRB for all Veridian Network sites outside of Pennsylvania that do not maintain their own institutional IRB. Receipt of this central IRB approval was a condition precedent to closing under Section 6.1(b)(ii) of the MCTA.
Field | Detail
Document | Internal Memorandum — Conditions Precedent Satisfaction
From | Sean Morrissey, Associate, Calderwood & Harkness LLP
To | Miriam Calloway, Partner, Calderwood & Harkness LLP
Date | July 5, 2023
Description | Internal memorandum from Sean Morrissey to Miriam Calloway confirming the satisfaction of all conditions precedent to the closing of the MCTA, as set forth in Article VI thereof. The memorandum confirms satisfaction of the following conditions:
Field | Detail
Document | Comprehensive Closing Checklist
Description | Detailed closing checklist prepared by Calderwood & Harkness LLP listing all documents, signature pages, certificates, conditions precedent, and deliverables required for each of the three key transaction dates: (a) the signing date (June 28, 2023); (b) the closing date (July 5, 2023); and (c) the effective date (July 18, 2023). The checklist is organized in tabular format with columns for: item number, document description, responsible party, due date, delivery date, and completion status. All items required for signing, closing, and effectiveness have been marked as complete as of the date of binder assembly (July 18, 2023), with the exception of certain post-closing deliverables (including site insurance certificates from Sites 006 through 038 and additional Individual Site Agreement joinders for sites not yet activated), which are tracked separately.
Field | Detail
Document | Email — Engagement Kick-Off
From | Miriam Calloway, Partner, Calderwood & Harkness LLP
To | Rebecca Liang, Esq., Associate General Counsel, Clinical Affairs, Penterra Pharmaceuticals Corp.
Date | March 20, 2023
Description | Email from Miriam Calloway to Rebecca Liang confirming Calderwood & Harkness's engagement on the MCTA matter (Matter No. 1018-00004). The email introduces the Calderwood & Harkness deal team, consisting of Joel Strauss (billing partner), Sean Morrissey (senior associate), and Christopher Aiken (associate). The email outlines the preliminary work plan for the drafting and negotiation of the MCTA and ancillary agreements for Protocol PPC-4871-III (CLARION) and requests key background documents, including the draft protocol, the Veridian site network structure and organizational documents, and any prior correspondence between Penterra and Veridian regarding the proposed collaboration.
Field | Detail
Document | Transmittal Letter — First Draft Master Clinical Trial Agreement
From | Miriam Calloway, Partner, Calderwood & Harkness LLP
To | Allison Whitmore, Partner, Whitmore, Jansen & Callahan LLP
Date | April 7, 2023
Description | Transmittal letter from Miriam Calloway to Allison Whitmore (counsel for Veridian Health Research Network, Inc.) transmitting the initial draft of the Master Clinical Trial Agreement for Protocol PPC-4871-III (CLARION). The letter identifies the key commercial and legal terms reflected in the draft, notes areas where bracketed language or open issues remain, and requests that Whitmore, Jansen & Callahan provide a marked-up version of the draft within three weeks (i.e., by April 28, 2023).
Field | Detail
Document | Email — Follow-Up on Indemnification Issues
From | Sean Morrissey, Associate, Calderwood & Harkness LLP
To | David Kesselman, Associate, Whitmore, Jansen & Callahan LLP
Date | May 8, 2023
Description | Email from Sean Morrissey to David Kesselman following up on the May 5, 2023 indemnification term sheet (see Tab 54) circulated by Penterra. The email addresses the key indemnification provisions under negotiation, including: (a) the per-subject medical care cap of $500,000; (b) the aggregate indemnification cap of $15,000,000; (c) the scope of uncapped indemnification for product-defect claims; (d) the carve-outs for investigator negligence and unauthorized protocol deviations; and (e) the 30-calendar-day notice requirement for indemnification claims. The email requests Veridian's position on each of these issues and proposes a call to discuss remaining open points.
Field | Detail
Document | Transmittal Letter — Second Draft Master Clinical Trial Agreement
From | Miriam Calloway, Partner, Calderwood & Harkness LLP
To | Allison Whitmore, Partner, Whitmore, Jansen & Callahan LLP
Date | May 19, 2023
Description | Transmittal letter from Miriam Calloway to Allison Whitmore transmitting the Second Draft of the Master Clinical Trial Agreement, together with a tracked-changes redline against the First Draft. The letter summarizes the key revisions reflected in the Second Draft, including: (a) incorporation of Penterra's responses to Veridian's initial markup of the First Draft; (b) revised indemnification provisions reflecting the May 5 indemnification term sheet; (c) updated budget and payment schedule; and (d) revised insurance requirements. The letter requests that Whitmore, Jansen & Callahan provide a marked-up version of the Second Draft within two weeks (i.e., by June 2, 2023).
Field | Detail
Document | Letter — Publication Rights Negotiation
From | Miriam Calloway, Partner, Calderwood & Harkness LLP
To | Allison Whitmore, Partner, Whitmore, Jansen & Callahan LLP
Date | May 22, 2023
Description | Letter from Miriam Calloway to Allison Whitmore addressing the publication rights provisions of the MCTA, which had emerged as a significant point of negotiation between the parties. The letter acknowledges Veridian's insistence on preserving investigator academic freedom with respect to publication of CLARION trial results, consistent with Veridian's obligations to its academic medical center affiliates. The letter proposes a compromise framework consisting of a 60-day sponsor review period for proposed publications, during which Penterra may review manuscripts solely for the identification of Confidential Information and patentable subject matter, with an additional delay of up to 90 calendar days (beyond the initial 60-day review period) in the event that Penterra identifies patentable subject matter requiring the filing of patent applications prior to publication. The letter notes that this framework is consistent with prevailing industry practice and balances the legitimate interests of both parties.
Field | Detail
Document | Email — Scheduling In-Person Negotiation Session
From | Miriam Calloway, Partner, Calderwood & Harkness LLP
To | Allison Whitmore, Partner, Whitmore, Jansen & Callahan LLP
Date | June 1, 2023
Description | Email from Miriam Calloway to Allison Whitmore p