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Contract analysis / matter-closing-confirmation-letter.docx
matter-closing-confirmation-letter.docx
1018-00004 · 37 clauses
High · 2 Medium · 3 Standard · 1
1. Purpose and Effective Date Confirmation Standard
⚑ Commercial term
1. Purpose and Effective Date Confirmation I write to confirm the effective date of the Master Clinical Trial Agreement (the "MCTA") and the formal closing of Calderwood & Harkness LLP Matter No. 1018-00004. This letter serves as the firm's official matter closing confirmation and provides a comprehensive record of the transaction documents, conditions precedent, and ongoing post-closing obligations for Penterra Phar
2. Summary of Transaction Timeline
2. Summary of Transaction Timeline For the benefit of your records, set forth below is a chronological summary of the key milestones achieved during the negotiation and execution of the MCTA and related ancillary agreements: The above timeline reflects a negotiation period of approximately ninety (90) days from initial draft circulation through execution, which is consistent with the scope and complexity of a multi-s
3. Summary of Executed Documents
3. Summary of Executed Documents The following is a comprehensive listing of all executed documents comprising the transaction, each of which has been included in the closing binder referenced in Section 5 below:
1. Master Clinical Trial Agreement (execution version, dated June 28, 2023), by and betwe
1. Master Clinical Trial Agreement (execution version, dated June 28, 2023), by and between Penterra Pharmaceuticals Corp. and Veridian Health Research Network, Inc.
2. MCTA Signature Pages — executed counterpart signature pages from Penterra Pharmaceutic
2. MCTA Signature Pages — executed counterpart signature pages from Penterra Pharmaceuticals Corp. (executed by Nathaniel Briggs, Esq., Vice President & General Counsel), Veridian Health Research Network, Inc. (executed by Dr. Franklin Osei, President & Chief Executive Officer), and Graystone University Medical Center (executed by Dr. William Corwin, President, as lead site)
3. Exhibit A — Protocol Synopsis (PPC-4871-III / CLARION), providing a summary of the Pro
3. Exhibit A — Protocol Synopsis (PPC-4871-III / CLARION), providing a summary of the Protocol objectives, study design, endpoints, inclusion/exclusion criteria, and anticipated enrollment targets
4. Exhibit B — Budget and Payment Schedule, reflecting a total budget of $80,000,000, all
4. Exhibit B — Budget and Payment Schedule, reflecting a total budget of $80,000,000, allocated as follows:
5. Exhibit C — Form of Individual Site Agreement (Joinder), the template agreement pursua
5. Exhibit C — Form of Individual Site Agreement (Joinder), the template agreement pursuant to which each participating Veridian Network site will join the MCTA and agree to be bound by its terms
6. Exhibit D — Subject-Injury Indemnification Provisions, including: (i) per-subject medi High
⚑ Indemnity / guarantee obligation
6. Exhibit D — Subject-Injury Indemnification Provisions, including: (i) per-subject medical care cap of $500,000; (ii) aggregate cap of $15,000,000 for all subject-injury claims; (iii) uncapped indemnification for claims arising from product-defect or manufacturing-defect causes of action; and (iv) site indemnity capped at $5,000,000 per site, per occurrence, and $20,000,000 in the aggregate
7. Exhibit E — Insurance Requirements and Certificate Forms, specifying: (i) Penterra's c
7. Exhibit E — Insurance Requirements and Certificate Forms, specifying: (i) Penterra's clinical trial liability insurance of $25,000,000 per occurrence / $75,000,000 aggregate, provided by Briarcliff Mutual Insurance Company under Policy No. BM-CTL-2023-04182, with a subject-injury sublimit of $10,000,000 per occurrence / $50,000,000 aggregate; and (ii) Veridian/site insurance requirements of $5,000,000 per occurren
8. Exhibit F — Confidentiality and Data Protection Provisions, establishing mutual confid Medium
⚑ Confidentiality undertaking
8. Exhibit F — Confidentiality and Data Protection Provisions, establishing mutual confidentiality obligations with a ten (10)-year term from the date of disclosure of each item of Confidential Information
9. Exhibit G — Intellectual Property and Publication Rights, providing for Penterra's six
9. Exhibit G — Intellectual Property and Publication Rights, providing for Penterra's sixty (60)-day review period for proposed publications and a ninety (90)-day patent delay period to permit the filing of patent applications prior to public disclosure
10. Exhibit H — Regulatory Compliance Representations and Covenants, setting forth repres
10. Exhibit H — Regulatory Compliance Representations and Covenants, setting forth representations, warranties, and ongoing covenants regarding compliance with applicable federal and state regulatory requirements, including Good Clinical Practice (GCP), FDA regulations (21 CFR Parts 50, 56, 312, and 812), Anti-Kickback Statute, and the Physician Payments Sunshine Act
11. Exhibit I — Form of Investigator Undertaking, the template acknowledgment to be execu
11. Exhibit I — Form of Investigator Undertaking, the template acknowledgment to be executed by each site investigator confirming acceptance of responsibilities under the Protocol and applicable regulations
12. Exhibit J — Safety Reporting Procedures, establishing: (i) Serious Adverse Event (SAE
12. Exhibit J — Safety Reporting Procedures, establishing: (i) Serious Adverse Event (SAE) reporting within twenty-four (24) hours of site awareness; and (ii) IND safety report submission timelines in accordance with 21 CFR § 312.32 (seven (7)-day reports for fatal or life-threatening unexpected adverse reactions; fifteen (15)-day reports for all other serious and unexpected adverse reactions)
13. Exhibit K — Approved Subcontractors List, identifying the following pre-approved subc
13. Exhibit K — Approved Subcontractors List, identifying the following pre-approved subcontractors: (i) Meridian CRO (contract research organization services); (ii) Pinnacle Data Solutions (electronic data capture and data management); and (iii) Northbridge Bioanalytical Laboratories (bioanalytical and pharmacokinetic sample analysis)
14. Schedule 1 — List of 38 Participating Veridian Network Sites, identifying each site b
14. Schedule 1 — List of 38 Participating Veridian Network Sites, identifying each site by site number, institution name, principal investigator, location, and applicable Institutional Review Board
15. Individual Site Agreement — Graystone University Medical Center (Site 001), with Prin
15. Individual Site Agreement — Graystone University Medical Center (Site 001), with Principal Investigator Dr. Catherine Aldridge and IRB oversight by the Graystone University Institutional Review Board (IORG Registration No. IRB00012847)
16. Individual Site Agreement — Lakemont Medical Center (Site 002), with Co-Principal Inv
16. Individual Site Agreement — Lakemont Medical Center (Site 002), with Co-Principal Investigator Dr. Howard Matsuoka and IRB oversight by the Veridian Central IRB
17. Individual Site Agreement — Haverford Regional Medical Center (Site 003)
17. Individual Site Agreement — Haverford Regional Medical Center (Site 003)
18. Individual Site Agreement — Cedar Falls University Hospital (Site 004)
18. Individual Site Agreement — Cedar Falls University Hospital (Site 004)
19. Individual Site Agreement — Weston Memorial Health System (Site 005)
19. Individual Site Agreement — Weston Memorial Health System (Site 005)
20. Principal Investigator Agreement — Dr. Catherine Aldridge, designating Dr. Aldridge a
20. Principal Investigator Agreement — Dr. Catherine Aldridge, designating Dr. Aldridge as Global Principal Investigator for the CLARION Trial
21. Co-Principal Investigator Agreement — Dr. Howard Matsuoka, designating Dr. Matsuoka a
21. Co-Principal Investigator Agreement — Dr. Howard Matsuoka, designating Dr. Matsuoka as Co-Principal Investigator 22. intellectual Property Side Letter (execution version, dated June 28, 2023), supplementing the intellectual property provisions of the MCTA with respect to certain pre-existing Veridian intellectual property and biomarker-related inventions
23. Closing Certificate — Penterra Pharmaceuticals Corp., certifying satisfaction of cond
23. Closing Certificate — Penterra Pharmaceuticals Corp., certifying satisfaction of conditions precedent and accuracy of representations and warranties as of the Effective Date
24. Closing Certificate — Veridian Health Research Network, Inc., certifying satisfaction
24. Closing Certificate — Veridian Health Research Network, Inc., certifying satisfaction of conditions precedent and accuracy of representations and warranties as of the Effective Date
25. Secretary's Certificate — Penterra Pharmaceuticals Corp., certifying board authorizat
25. Secretary's Certificate — Penterra Pharmaceuticals Corp., certifying board authorization of the MCTA and incumbency of Nathaniel Briggs, Esq. (Vice President & General Counsel) and Dr. Anand Raghavan (Senior Vice President, Clinical Development)
26. Secretary's Certificate — Veridian Health Research Network, Inc., certifying board au
26. Secretary's Certificate — Veridian Health Research Network, Inc., certifying board authorization of the MCTA and incumbency of Dr. Franklin Osei (President & Chief Executive Officer) and Gregory Callahan (Senior Vice President & General Counsel)
27. Officer's Certificate — Penterra Pharmaceuticals Corp., confirming the bringdown of r
27. Officer's Certificate — Penterra Pharmaceuticals Corp., confirming the bringdown of representations and warranties as of July 5, 2023, and certifying that no material adverse change has occurred since the date of execution
4. Conditions Precedent Satisfaction
4. Conditions Precedent Satisfaction We confirm that all conditions precedent to the effectiveness of the MCTA, as specified in Section 12.1 thereof, were satisfied in full as of July 5, 2023. Specifically, the following conditions were satisfied: (a) Penterra Insurance Certificate. Delivery by Penterra of its certificate of insurance from Briarcliff Mutual Insurance Company (Policy No. BM-CTL-2023-04182), evidencing
5. Delivery of Closing Binder
5. Delivery of Closing Binder We confirm that the complete closing binder for this transaction has been compiled by this firm and is being delivered concurrently with this letter. The closing binder is organized by tab number in accordance with the enclosed Closing Binder Index and Table of Contents, which corresponds to the document listing set forth in Section 3 above. Each tab contains a fully executed original or
6. Key Terms Reminder — Governing Law and Dispute Resolution Medium
⚑ Notice / time limit to track
6. Key Terms Reminder — Governing Law and Dispute Resolution For ease of reference, we provide the following brief reminder regarding the governing law and dispute resolution provisions of the MCTA, as set forth in Article XV thereof: Governing Law. The MCTA is governed by and construed in accordance with the laws of the State of New York, without regard to conflicts of law principles that would result in the applica
7. Ongoing Post-Closing Obligations and Action Items Medium
⚑ Liability cap to check against exposure
7. Ongoing Post-Closing Obligations and Action Items Although the negotiation and execution of the MCTA and ancillary agreements is now complete, we wish to highlight the following ongoing post-closing obligations and near-term action items for Penterra's attention. While Calderwood & Harkness's active engagement on this matter is concluding, we believe it is prudent to memorialize these items for the benefit of Pent
8. Engagement Team and Ongoing Support
8. Engagement Team and Ongoing Support The Calderwood & Harkness LLP engagement team for Matter No. 1018-00004 was as follows: • Miriam Calloway, Partner — Responsible Partner • Joel Strauss, Partner — Billing Partner • Sean Morrissey, Associate — Lead Associate • Christopher Aiken, Associate — Working Associate With the closing of Matter No. 1018-00004, Calderwood & Harkness LLP's engagement for the negotiation, dra
9. Acknowledgment and Appreciation
9. Acknowledgment and Appreciation We wish to express our sincere appreciation for the opportunity to represent Penterra Pharmaceuticals Corp. in connection with this significant and complex clinical trial transaction. The CLARION Trial represents a substantial commitment by Penterra to advancing the treatment of advanced hepatocellular carcinoma, and we are proud to have played a role in bringing the MCTA and the as
1. Closing Binder (3 hard copies), with Closing Binder Index and Table of Contents
1. Closing Binder (3 hard copies), with Closing Binder Index and Table of Contents
2. Electronic closing binder access credentials (transmitted separately via secure encryp High
⚑ Indemnity / guarantee obligation
2. Electronic closing binder access credentials (transmitted separately via secure encrypted email) Date | Milestone March 20, 2023 | Calderwood & Harkness matter opened (Matter No. 1018-00004); engagement confirmed by executed engagement letter April 7, 2023 | First draft of MCTA circulated to Whitmore, Jansen & Callahan LLP ("WJC"), counsel for Veridian April 28, 2023 | Receipt of Veridian/WJC initial markup of the