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Contract analysis / conditions-precedent-satisfaction-memo.docx
conditions-precedent-satisfaction-memo.docx
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I. Executive Summary
I. Executive Summary The purpose of this memorandum is to confirm that all conditions precedent to the closing of the Master Clinical Trial Agreement (the "MCTA"), dated June 28, 2023, by and between Penterra Pharmaceuticals Corp., a Delaware corporation ("Penterra" or the "Sponsor"), and Veridian Health Research Network, Inc., a Delaware non-profit corporation ("Veridian" or the "Site Network"), have been satisfied
II. Background
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⚑ Indemnity / guarantee obligation
II. Background A. The Parties Penterra Pharmaceuticals Corp. ("Penterra" or the "Sponsor") is a Delaware corporation headquartered at 200 Biopharma Boulevard, Suite 1400, Princeton, New Jersey 08540. Penterra is a publicly traded biopharmaceutical company whose common stock is listed on the Nasdaq Global Select Market under the ticker symbol "PTRA." Penterra is engaged in the discovery, development, and commercializa
III. Conditions Precedent — Summary Table
III. Conditions Precedent — Summary Table The following table provides a summary of all conditions precedent to closing of the MCTA, together with the responsible party, deliverable description, date received or confirmed, and current status. Each item is discussed in further detail in Section IV below.
IV. Detailed Analysis of Each Condition Precedent
IV. Detailed Analysis of Each Condition Precedent A. Execution and Delivery of the MCTA and Signature Pages
Section 12.1(a) of the MCTA required the execution and delivery of the MCTA by each of the
Section 12.1(a) of the MCTA required the execution and delivery of the MCTA by each of the parties and by Graystone University Medical Center as the designated lead site institution. The Execution Version of the MCTA was finalized and circulated to all parties for execution on June 26, 2023. Execution occurred on June 28, 2023, and Calderwood & Harkness has confirmed receipt of all required signature pages, as follow
Section 12.1(b) of the MCTA required Penterra, as Sponsor, to deliver certificates of insu
Section 12.1(b) of the MCTA required Penterra, as Sponsor, to deliver certificates of insurance evidencing clinical trial liability coverage meeting the minimum coverage requirements set forth in Exhibit E of the MCTA within fifteen (15) business days of the date of execution of the MCTA. Exhibit E specifies minimum per-occurrence and aggregate limits, requires clinical trial-specific coverage, includes a subject-inj
Section 12.1(c) of the MCTA required Veridian and each participating site institution to d
Section 12.1(c) of the MCTA required Veridian and each participating site institution to deliver certificates of insurance evidencing general liability and professional liability coverage of at least Five Million Dollars ($5,000,000) per occurrence and Ten Million Dollars ($10,000,000) in the aggregate within fifteen (15) business days of execution of the MCTA. With respect to the closing condition specifically, Sect
Section 12.1(d) of the MCTA required receipt of IRB approval for Protocol PPC-4871-III (CL
Section 12.1(d) of the MCTA required receipt of IRB approval for Protocol PPC-4871-III (CLARION) at each of the two designated lead enrollment sites prior to closing. This condition was designed to confirm that the lead sites would be positioned to commence enrollment activities promptly following the Effective Date of the MCTA. Graystone University Medical Center (Site 001). Graystone University Medical Center maint
Section 12.1(e) of the MCTA required the execution and delivery of principal investigator
Section 12.1(e) of the MCTA required the execution and delivery of principal investigator and co-principal investigator agreements and investigator undertaking forms (in the form attached as Exhibit I to the MCTA) prior to closing, with respect to the designated Global Principal Investigator and Co-Principal Investigator for the CLARION trial. Dr. Catherine Aldridge, M.D., Ph.D. — Global Principal Investigator. Dr. A
Section 12.1(f) of the MCTA required the completion and delivery of financial disclosure c
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⚑ Liability cap to check against exposure
Section 12.1(f) of the MCTA required the completion and delivery of financial disclosure certification forms in accordance with 21 C.F.R. Part 54 (Financial Disclosure by Clinical Investigators) for the Global Principal Investigator and the Co-Principal Investigator prior to closing. Financial disclosure certifications are required by FDA regulations to identify any financial interests or arrangements that could affe
Section 12.1(g) of the MCTA required the delivery by each party of a secretary's certifica
Section 12.1(g) of the MCTA required the delivery by each party of a secretary's certificate confirming due corporate authorization of the MCTA and ancillary agreements. Penterra Pharmaceuticals Corp. A Secretary's Certificate was received from Penterra, executed by the Secretary of Penterra Pharmaceuticals Corp. and dated June 28, 2023. The Secretary's Certificate certifies the following: (i) That the Board of Direc
Section 12.1(h) of the MCTA required the delivery by each party of a closing certificate,
Section 12.1(h) of the MCTA required the delivery by each party of a closing certificate, together with an officer's certificate providing a representations and warranties bringdown, as of the date of closing. Penterra Closing Certificate. A closing certificate was received from Penterra, executed by Nathaniel Briggs, Esq., Vice President and General Counsel, on behalf of Penterra Pharmaceuticals Corp., dated July 5,
I. Execution and Delivery of Ancillary Agreements
I. Execution and Delivery of Ancillary Agreements
Section 12.1(i) of the MCTA required the execution and delivery of certain ancillary agree
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⚑ Non-compete / exclusivity restraint
Section 12.1(i) of the MCTA required the execution and delivery of certain ancillary agreements as conditions precedent to closing, including the intellectual Property Side Letter and Individual Site Agreements for the two designated lead sites. intellectual Property Side Letter. The intellectual Property Side Letter was executed concurrently with the MCTA on June 28, 2023. The IP Side Letter was signed by authorized
Section 12.1(j) of the MCTA required that all exhibits and schedules to the MCTA be finali
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⚑ Non-compete / exclusivity restraint
Section 12.1(j) of the MCTA required that all exhibits and schedules to the MCTA be finalized and delivered in their final, agreed-upon form as of the closing date. Calderwood & Harkness has confirmed that each of the following exhibits and schedules has been finalized, agreed to by both parties, and delivered as part of the execution version of the MCTA: Exhibit A — Protocol Synopsis (PPC-4871-III / CLARION). A summ
V. Post-Closing Obligations and Remaining Deliverables
V. Post-Closing Obligations and Remaining Deliverables Although all conditions precedent to closing have been satisfied as of July 5, 2023, several items remain outstanding as post-closing obligations under the MCTA. These items were not conditions to closing but are required to be delivered on a rolling basis or at specified intervals following the Effective Date. The engagement team will monitor the delivery of eac
1. Remaining Site Insurance Certificates. Certificates of insurance from the remaining thi
1. Remaining Site Insurance Certificates. Certificates of insurance from the remaining thirty-six (36) Veridian Network sites (i.e., all sites beyond Graystone University Medical Center and Lakemont Medical Center) are required to be delivered as each site executes its Individual Site Agreement (Joinder) pursuant to Exhibit C of the MCTA. Each certificate is due within fifteen (15) business days of the date of execut
2. Remaining Individual Site Agreements (Joinders). Individual Site Agreements for Sites 0
2. Remaining Individual Site Agreements (Joinders). Individual Site Agreements for Sites 003 through 038 are to be executed on a rolling basis as sites are activated for the CLARION trial. As noted in Section IV.I above, representative joinder agreements are in preparation for Haverford Regional Medical Center (Site 003, Boston, MA), Cedar Falls University Hospital (Site 004, Denver, CO), and Weston Memorial Health S
3. Remaining Investigator Signature Pages, Undertakings, and Financial Disclosure Certific
3. Remaining Investigator Signature Pages, Undertakings, and Financial Disclosure Certifications. Principal Investigator Agreements, Investigator Undertakings (Exhibit I forms), and Financial Disclosure Certifications (21 C.F.R. Part 54) for sub-investigators and site principal investigators at all thirty-eight (38) sites are to be collected as part of the site activation process. Calderwood & Harkness will coordinat
4. Form FDA 1572 Collection. The preparation and collection of Form FDA 1572 (Statement of
4. Form FDA 1572 Collection. The preparation and collection of Form FDA 1572 (Statement of Investigator) for each site investigator is being coordinated by Penterra's clinical operations team, specifically Jennifer Holt, Vice President, Clinical Operations, and Samantha Novak, Director, Clinical Contracts. Guidance has been provided in the Form 1572 Preparation Memorandum circulated on June 15, 2023. Calderwood & Har
5. Annual Insurance Certificate Renewal. Pursuant to Exhibit E of the MCTA, both parties a
5. Annual Insurance Certificate Renewal. Pursuant to Exhibit E of the MCTA, both parties are required to exchange updated certificates of insurance on an annual basis. The current Briarcliff Mutual policy (Policy No. BM-CTL-2023-04182) expires on March 31, 2024, and is renewable annually. Calderwood & Harkness will calendar the renewal date and coordinate with Penterra to ensure timely delivery of updated certificate
6. Closing Binder Assembly. Christopher Aiken, Associate, Calderwood & Harkness LLP, will
6. Closing Binder Assembly. Christopher Aiken, Associate, Calderwood & Harkness LLP, will be responsible for finalizing the closing binder containing all executed documents, certificates, exhibits, schedules, and ancillary agreements. The target date for completion and distribution of the closing binder is July 18, 2023, which will also serve as the Effective Date of the MCTA.
VI. Governing Law and Dispute Resolution Confirmation
Medium
⚑ Notice / time limit to track
VI. Governing Law and Dispute Resolution Confirmation For completeness, this memorandum confirms the governing law and dispute resolution provisions of the MCTA, as set forth in Article XIV thereof. Governing Law. The MCTA is governed by and shall be construed in accordance with the laws of the State of New York, without giving effect to any choice-of-law or conflicts-of-law rules or provisions that would cause the a
VII. Conclusion and Recommendation
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⚑ Confidentiality undertaking
VII. Conclusion and Recommendation Based upon the analysis set forth above, all conditions precedent to the closing of the Master Clinical Trial Agreement between Penterra Pharmaceuticals Corp. and Veridian Health Research Network, Inc., dated June 28, 2023, have been satisfied as of July 5, 2023. No conditions precedent remain outstanding, and no waivers were required. Accordingly, closing of the MCTA is confirmed e