[sheet: Closing Checklist]
Item No. | Tab No. | Category | Document Description | Responsible Party | Due Date | Milestone | Status | Date Completed | Notes / Comments
1 | 1.1 | Transaction Agreements | Execution Version — Master Clinical Trial Agreement between Penterra Pharmaceuticals Corp. and Veridian Health Research Network, Inc., dated June 28, 2023 (Protocol PPC-4871-III / CLARION; Total Deal Value: $80,000,000; Governing Law: New York) | Calderwood & Harkness LLP / Whitmore, Jansen & Callahan LLP | 2023-06-28 | Signing | Executed | 2023-06-28 | Final agreed draft dated June 23, 2023; execution version circulated June 26, 2023
2 | 1.2 | Transaction Agreements | Intellectual Property Side Letter — Execution Version, dated June 28, 2023 (governing inventions arising during CLARION trial) | Calderwood & Harkness LLP / Whitmore, Jansen & Callahan LLP | 2023-06-28 | Signing | Executed | 2023-06-28 | Executed concurrently with MCTA
3 | 2.1 | Signature Pages — Penterra | MCTA Signature Pages — Penterra Pharmaceuticals Corp. (signed by Nathaniel Briggs, VP & General Counsel) | Penterra | 2023-06-28 | Signing | Executed | 2023-06-28
4 | 2.2 | Signature Pages — Veridian | MCTA Signature Pages — Veridian Health Research Network, Inc. (signed by Dr. Franklin Osei, President & CEO) | Veridian | 2023-06-28 | Signing | Executed | 2023-06-28
5 | 2.3 | Signature Pages — Lead Site | MCTA Signature Pages — Graystone University Medical Center (signed by Dr. William Corwin, President) | Graystone / Veridian | 2023-06-28 | Signing | Executed | 2023-06-28 | Lead participating site institution
6 | 3.1 | MCTA Exhibits | Exhibit A — Protocol Synopsis (PPC-4871-III / CLARION): Phase III, randomized, double-blind, placebo-controlled; penterafenib (PPC-4871); advanced HCC; 1,200 subjects (2:1 randomization, 800 treatment : 400 placebo); primary endpoint: OS; secondary: PFS, ORR, DOR; 42-month enrollment; 60-month total duration; IND 157823; NCT05928174 | Penterra | 2023-06-28 | Signing | Executed | 2023-06-28 | Attached to MCTA
7 | 3.2 | MCTA Exhibits | Exhibit B — Budget and Payment Schedule: Per-patient fees $52,000 × 1,200 = $62,400,000; Start-up fees $75,000 × 38 = $2,850,000; Site maintenance $40,000/site × 38 × 3.5 yrs = $5,320,000; Investigator grants $1,500,000; Network coordination $300,000/qtr × 14 qtrs = $4,200,000; Technology/EDC $1,230,000; Contingency $2,500,000; Total $80,000,000; Payment terms Net 45 days | Penterra / Calderwood & Harkness LLP | 2023-06-28 | Signing | Executed | 2023-06-28 | Per-patient milestones: 25% at randomization ($13,000), 25% at Wk 12 ($13,000), 25% at Wk 24 ($13,000), 25% at completion ($13,000); Start-up: 50% at activation ($37,500), 50% at first patient ($37,500)
8 | 3.3 | MCTA Exhibits | Exhibit C — Form of Individual Site Agreement (Joinder) | Calderwood & Harkness LLP | 2023-06-28 | Signing | Executed | 2023-06-28 | Template for execution by each of 38 Veridian Network sites
9 | 3.4 | MCTA Exhibits | Exhibit D — Subject-Injury Indemnification Provisions: Sponsor indemnification of sites/investigators for subject injury (per-subject cap $500,000; aggregate cap $15,000,000 for medical care; uncapped for product-defect claims); carve-outs for investigator negligence, unauthorized protocol deviations, site breach; reciprocal site indemnity ($5,000,000 per site/per occurrence, $20,000,000 aggregate); 30-day notice requirement | Calderwood & Harkness LLP / Whitmore, Jansen & Callahan LLP | 2023-06-28 | Signing | Executed | 2023-06-28 | Final negotiated terms per indemnification term sheet dated May 5, 2023 and June 9 negotiation session
10 | 3.5 | MCTA Exhibits | Exhibit E — Insurance Requirements and Certificate Forms: Penterra — $25,000,000 per occurrence / $75,000,000 aggregate (Briarcliff Mutual, Policy No. BM-CTL-2023-04182; subject-injury sublimit $10,000,000 per occurrence / $50,000,000 aggregate); Veridian/Sites — $5,000,000 per occurrence / $10,000,000 aggregate; exchange within 15 business days of execution | Calderwood & Harkness LLP | 2023-06-28 | Signing | Executed | 2023-06-28 | Includes additional insured endorsement form
11 | 3.6 | MCTA Exhibits | Exhibit F — Confidentiality and Data Protection Provisions (10-year confidentiality term; HIPAA compliance per 45 C.F.R. Parts 160, 164) | Calderwood & Harkness LLP | 2023-06-28 | Signing | Executed | 2023-06-28
12 | 3.7 | MCTA Exhibits | Exhibit G — Intellectual Property and Publication Rights (Penterra retains exclusive ownership of trial data; 60-day review + 90-day patent delay; pre-existing IP retained by each party) | Calderwood & Harkness LLP | 2023-06-28 | Signing | Executed | 2023-06-28
13 | 3.8 | MCTA Exhibits | Exhibit H — Regulatory Compliance Representations and Covenants (21 C.F.R. Parts 11, 50, 54, 56, 312; ICH E6(R2); Anti-Kickback; Sunshine Act/Open Payments; FMV of investigator compensation) | Calderwood & Harkness LLP | 2023-06-28 | Signing | Executed | 2023-06-28
14 | 3.9 | MCTA Exhibits | Exhibit I — Form of Investigator Undertaking | Calderwood & Harkness LLP | 2023-06-28 | Signing | Executed | 2023-06-28 | Template for PI/sub-investigator execution
15 | 3.10 | MCTA Exhibits | Exhibit J — Safety Reporting Procedures (SAE: 24 hours from site awareness; IND safety reports: 7-day fatal/life-threatening, 15-day all others; coordination with Meridian CRO) | Calderwood & Harkness LLP / Penterra | 2023-06-28 | Signing | Executed | 2023-06-28
16 | 3.11 | MCTA Exhibits | Exhibit K — Approved Subcontractors List: Meridian Contract Research Organization, Inc. (CRO, Raleigh, NC); Pinnacle Data Solutions, Inc. (EDC, San Diego, CA); Northbridge Bioanalytical Laboratories, Inc. (Central Lab, Baltimore, MD) | Penterra | 2023-06-28 | Signing | Executed | 2023-06-28
17 | 3.12 | MCTA Schedules | Schedule 1 — List of Participating Veridian Network Sites (38 sites across 14 states); Lead sites: Graystone University Medical Center (Site 001, Philadelphia, PA), Lakemont Medical Center (Site 002, Chicago, IL) | Veridian / Penterra | 2023-06-28 | Signing | Executed | 2023-06-28 | Includes site number, institution name, address, PI, IRB of record, enrollment allocation
18 | 4.1 | Individual Site Agreements | Individual Site Agreement — Graystone University Medical Center (Site 001), 1200 University Avenue, Philadelphia, PA 19104; PI: Dr. Catherine Aldridge; IRB: Graystone University IRB (IRB00012847); signed by Dr. William Corwin | Graystone / Veridian | 2023-07-05 | Closing | Executed | 2023-07-02 | Lead enrollment site
19 | 4.2 | Individual Site Agreements | Individual Site Agreement — Lakemont Medical Center (Site 002), 4400 North Michigan Drive, Chicago, IL 60611; Co-PI: Dr. Howard Matsuoka; IRB: Veridian Central IRB | Lakemont / Veridian | 2023-07-05 | Closing | Executed | 2023-07-03 | Key enrollment site
20 | 4.3 | Individual Site Agreements | Individual Site Agreement — Haverford Regional Medical Center (Site 003), Boston, MA; IRB: Veridian Central IRB | Haverford / Veridian | 2023-07-05 | Closing | Executed | 2023-07-03
21 | 4.4 | Individual Site Agreements | Individual Site Agreement — Cedar Falls University Hospital (Site 004), Denver, CO; IRB: Veridian Central IRB | Cedar Falls / Veridian | 2023-07-05 | Closing | Executed | 2023-07-03
22 | 4.5 | Individual Site Agreements | Individual Site Agreement — Weston Memorial Health System (Site 005), Atlanta, GA; IRB: Veridian Central IRB | Weston / Veridian | 2023-07-05 | Closing | Executed | 2023-07-03
23 | 4.6 | Individual Site Agreements | Individual Site Agreements — Remaining Sites 006–038 (33 additional Veridian Network sites) | Veridian Network Sites | Post-Closing | Effective Date / Post-Closing | Pending | To be executed on a rolling basis as sites are activated; not a condition precedent to closing
24 | 5.1 | Investigator Agreements | Principal Investigator Agreement — Dr. Catherine Aldridge, M.D., Ph.D. (Global PI, Graystone University Medical Center) | Penterra / Dr. Aldridge | 2023-07-05 | Closing | Executed | 2023-07-01 | Includes FMV compensation, publication rights, financial disclosure, regulatory obligations
25 | 5.2 | Investigator Agreements | Co-Principal Investigator Agreement — Dr. Howard Matsuoka, M.D. (Co-PI, Lakemont Medical Center) | Penterra / Dr. Matsuoka | 2023-07-05 | Closing | Executed | 2023-07-02
26 | 5.3 | Investigator Documents | Executed Investigator Undertakings — Dr. Catherine Aldridge and Dr. Howard Matsuoka | Investigators | 2023-07-05 | Closing | Executed | 2023-07-02 | Per Exhibit I form
27 | 5.4 | Investigator Documents | Financial Disclosure Certifications (21 CFR Part 54) — Dr. Catherine Aldridge and Dr. Howard Matsuoka | Investigators | 2023-07-05 | Closing | Received | 2023-07-01 | Certifying absence/disclosure of financial interests in Penterra
28 | 6.1 | Closing Certificates — Penterra | Closing Certificate — Penterra Pharmaceuticals Corp. (signed by Nathaniel Briggs; representations and warranties true and correct as of July 5, 2023; all pre-closing obligations performed) | Penterra | 2023-07-05 | Closing | Executed | 2023-07-05
29 | 6.2 | Closing Certificates — Penterra | Secretary's Certificate — Penterra Pharmaceuticals Corp. (board resolutions authorizing MCTA; incumbency of Nathaniel Briggs and Dr. Anand Raghavan; bylaws and certificate of incorporation attached) | Penterra | 2023-07-05 | Closing | Executed | 2023-07-05 | Delaware corporation; Nasdaq: PTRA
30 | 6.3 | Closing Certificates — Penterra | Officer's Certificate — Penterra (representations and warranties bringdown; true and correct in all material respects as of closing date July 5, 2023) | Penterra | 2023-07-05 | Closing | Executed | 2023-07-05
31 | 6.4 | Closing Certificates — Veridian | Closing Certificate — Veridian Health Research Network, Inc. (signed by Dr. Franklin Osei; representations and warranties true and correct as of July 5, 2023; all pre-closing obligations performed) | Veridian | 2023-07-05 | Closing | Executed | 2023-07-05
32 | 6.5 | Closing Certificates — Veridian | Secretary's Certificate — Veridian Health Research Network, Inc. (board resolutions authorizing MCTA; incumbency of Dr. Franklin Osei and Gregory Callahan; organizational documents attached) | Veridian | 2023-07-05 | Closing | Executed | 2023-07-05 | Delaware 501(c)(3) corporation; EIN 23-4178205
33 | 7.1 | Conditions Precedent — Insurance | Certificate of Insurance — Penterra: Briarcliff Mutual Insurance Company, Policy No. BM-CTL-2023-04182 (policy period April 1, 2023 – March 31, 2024); $25,000,000 per occurrence / $75,000,000 aggregate; subject-injury sublimit $10,000,000 per occurrence / $50,000,000 aggregate; Veridian and each site named as additional insured | Penterra / Briarcliff Mutual | 2023-07-05 | Closing | Received | 2023-07-02 | Certificate delivered via Calderwood & Harkness to WJC; due within 15 business days of MCTA execution (by July 20, 2023); delivered early
34 | 7.2 | Conditions Precedent — Insurance | Additional Insured Endorsement — Briarcliff Mutual (endorsing Policy No. BM-CTL-2023-04182 to name Veridian Health Research Network, Inc. and each participating site) | Briarcliff Mutual / Penterra | 2023-07-05 | Closing | Received | 2023-07-02 | Requested per letter to Karen Tremblay, VP, Life Sciences Lines
35 | 7.3 | Conditions Precedent — Insurance | Certificates of Insurance — Veridian/Participating Sites (general liability and professional liability: $5,000,000 per occurrence / $10,000,000 aggregate); Lead Sites (Graystone, Lakemont) | Veridian / Sites | 2023-07-05 | Closing | Received | 2023-07-03 | Certificates for lead sites received; remaining sites due within 15 business days of execution (by July 20, 2023)
36 | 7.4 | Conditions Precedent — IRB Approvals | IRB Approval — Graystone University Institutional Review Board (IRB00012847) for Protocol PPC-4871-III at Graystone University Medical Center (Site 001) | Graystone | 2023-07-05 | Closing | Received | 2023-06-30 | Individual site IRB approval required for lead Pennsylvania sites
37 | 7.5 | Conditions Precedent — IRB Approvals | IRB Approval — Veridian Central IRB for Protocol PPC-4871-III at Lakemont Medical Center (Site 002) and non-Pennsylvania network sites | Veridian | 2023-07-05 | Closing | Received | 2023-07-01 | Central IRB serving network sites outside Pennsylvania per IRB reliance/authorization agreements
38 | 7.6 | Conditions Precedent — Investigator Pages | Executed Investigator Signature Pages — Dr. Catherine Aldridge (Global PI) and Dr. Howard Matsuoka (Co-PI) | Investigators / Veridian | 2023-07-05 | Closing | Received | 2023-07-02 | Required condition precedent to closing
39 | 8.1 | Regulatory & Compliance | FDA Form 1572 (Statement of Investigator) — Dr. Catherine Aldridge (completed per preparation memorandum) | Dr. Aldridge / Penterra | 2023-07-05 | Closing | Received | 2023-07-01 | Filed with IND 157823
40 | 8.2 | Regulatory & Compliance | FDA Form 1572 (Statement of Investigator) — Dr. Howard Matsuoka | Dr. Matsuoka / Penterra | 2023-07-05 | Closing | Received | 2023-07-02 | Filed with IND 157823
41 | 8.3 | Regulatory & Compliance | Fair Market Value Analysis — Investigator compensation confirmed at FMV (per-patient $52,000; investigator grants $1,500,000 total); Anti-Kickback safe harbor compliance confirmed | Calderwood & Harkness LLP | 2023-06-28 | Signing | Completed | 2023-06-15 | Internal memorandum; Sunshine Act reporting procedures established
42 | 9.1 | Negotiation Record (Reference) | First Draft MCTA — circulated April 7, 2023 | Calderwood & Harkness LLP | 2023-04-07 | Pre-Signing | N/A | 2023-04-07 | Reference copy; superseded
43 | 9.2 | Negotiation Record (Reference) | Veridian/WJC Initial Markup — received April 28, 2023 | Whitmore, Jansen & Callahan LLP | 2023-04-28 | Pre-Signing | N/A | 2023-04-28 | Reference copy; superseded
44 | 9.3 | Negotiation Record (Reference) | Indemnification Term Sheet — proposed by Penterra, circulated May 5, 2023 | Calderwood & Harkness LLP | 2023-05-05 | Pre-Signing | N/A | 2023-05-05 | Basis for Exhibit D; superseded by final terms
45 | 9.4 | Negotiation Record (Reference) | Second Draft MCTA — circulated May 19, 2023 | Calderwood & Harkness LLP | 2023-05-19 | Pre-Signing | N/A | 2023-05-19 | Reference copy; superseded
46 | 9.5 | Negotiation Record (Reference) | Veridian/WJC Second Markup — received June 2, 2023 | Whitmore, Jansen & Callahan LLP | 2023-06-02 | Pre-Signing | N/A | 2023-06-02 | Reference copy; superseded
47 | 9.6 | Negotiation Record (Reference) | Near-Final Draft MCTA — circulated June 16, 2023 | Calderwood & Harkness LLP | 2023-06-16 | Pre-Signing | N/A | 2023-06-16 | Reference copy; superseded
48 | 9.7 | Negotiation Record (Reference) | Final Agreed Draft MCTA — June 23, 2023 | Calderwood & Harkness LLP | 2023-06-23 | Pre-Signing | N/A | 2023-06-23 | Basis for execution version
49 | 10.1 | Post-Closing Deliverables | Closing Binder Index and Table of Contents | Calderwood & Harkness LLP | 2023-07-18 | Effective Date | Completed | 2023-07-15 | Compiled by Christopher Aiken
50 | 10.2 | Post-Closing Deliverables | Closing Memorandum — Post-Closing Summary (Matter 1018-00004) | Calderwood & Harkness LLP (Miriam Calloway) | 2023-07-18 | Effective Date | Completed | 2023-07-18 | Addressed to Nathaniel Briggs and Rebecca Liang at Penterra; confirms effective date
51 | 10.3 | Post-Closing Deliverables | Matter Closing Confirmation Letter — Calderwood & Harkness to Penterra | Calderwood & Harkness LLP (Miriam Calloway) | 2023-07-18 | Effective Date | Completed | 2023-07-18 | Confirms effective date, closing of matter 1018-00004, delivery of closing binder
52 | 10.4 | Post-Closing Deliverables | Conditions Precedent Satisfaction Memorandum — dated July 5, 2023 | Calderwood & Harkness LLP (Sean Morrissey) | 2023-07-05 | Closing | Completed | 2023-07-05 | Confirms all conditions precedent satisfied: insurance certificates, IRB approvals (Graystone IRB00012847, Veridian Central IRB), executed investigator signature pages, all ancillary agreements
53 | 11.1 | Ongoing Obligations | Annual Renewal — Briarcliff Mutual Insurance Certificate (Policy BM-CTL-2023-04182 expires March 31, 2024) | Penterra | 2024-03-31 | Post-Closing | Pending | Must renew annually; provide updated certificate to Veridian within 15 business days of renewal
54 | 11.2 | Ongoing Obligations | Execution of Remaining Individual Site Agreements (Sites 006–038; 33 sites) | Veridian Network Sites | Rolling | Post-Closing | Pending | As sites are activated; target FPI August 14, 2023
55 | 11.3 | Ongoing Obligations | Annual Site Insurance Certificate Exchange | Veridian / Sites | Annually | Post-Closing | Pending | Certificates due annually per Exhibit E
56 | 11.4 | Ongoing Obligations | Document Retention — Site source documents for minimum 15 years post-study completion (projected through August 2043) | Veridian / Sites | August 2043 | Post-Closing | Pending | Per MCTA Exhibit F and applicable regulations
[sheet: Key Dates Summary]
Milestone | Date | Description | Status
Matter Opened | 2023-03-20 | Calderwood & Harkness LLP engaged by Penterra; Matter No. 1018-00004 opened | Completed
First Draft MCTA Circulated | 2023-04-07 | First draft MCTA transmitted by Calderwood & Harkness to Whitmore, Jansen & Callahan LLP | Completed
Counterparty Initial Markup | 2023-04-28 | Veridian/WJC initial markup of MCTA received | Completed
Indemnification Term Sheet | 2023-05-05 | Penterra's proposed indemnification term sheet exchanged | Completed
Second Draft MCTA | 2023-05-19 | Second draft MCTA circulated to WJC | Completed
Counterparty Second Markup | 2023-06-02 | Veridian/WJC second markup received | Completed
In-Person Negotiation Session | 2023-06-09 | Negotiation session at WJC offices, 1500 Market Street, Suite 3200, Philadelphia, PA 19102 | Completed
Near-Final Draft | 2023-06-16 | Near-final draft MCTA circulated | Completed
Final Agreed Draft | 2023-06-23 | Final clean draft agreed by all parties | Completed
MCTA Signing Date | 2023-06-28 | Execution of MCTA by Penterra (Nathaniel Briggs), Veridian (Dr. Franklin Osei), Graystone (Dr. William Corwin); IP Side Letter executed concurrently | Completed
Closing Date | 2023-07-05 | All conditions precedent satisfied: insurance certificates delivered, IRB approvals received (Graystone IRB00012847, Veridian Central IRB), executed investigator signature pages received | Completed
Effective Date / Matter Closed | 2023-07-18 | MCTA effective; Calderwood & Harkness matter 1018-00004 closed; closing binder delivered | Completed
Target First Patient In (FPI) | 2023-08-14 | Target date for first subject enrollment in CLARION trial | Upcoming
Briarcliff Policy Expiration | 2024-03-31 | Briarcliff Mutual Policy BM-CTL-2023-04182 expiration (renewable annually) | Upcoming
Projected Last Patient In | 2027-02-01 | Projected end of 42-month enrollment period | Future
Projected Study Completion | 2028-08-01 | Projected end of 60-month total study duration (enrollment + 18-month follow-up) | Future
[sheet: Party & Contact Reference]
Party / Entity | Role | Authorized Signatory | Key Contact | Address | Counsel
Penterra Pharmaceuticals Corp. | Sponsor | Nathaniel Briggs, VP & General Counsel; Dr. Anand Raghavan, CEO | Rebecca Liang, Assoc. General Counsel, Clinical Affairs; Samantha Novak, Director, Clinical Contracts; Jennifer Holt, VP, Clinical Operations | 200 Biopharma Boulevard, Suite 1400, Princeton, NJ 08540 | Calderwood & Harkness LLP (Miriam Calloway, Joel Strauss, Sean Morrissey, Christopher Aiken)
Veridian Health Research Network, Inc. | Site Network (Counterparty) | Dr. Franklin Osei, President & CEO | Gregory Callahan, VP, Legal & Compliance; Patricia Dunne, Director, Sponsored Research Agreements; Diane Prescott, COO; Dr. Lena Marchetti, SVP, Research Administration | 750 Research Parkway, 8th Floor, Philadelphia, PA 19104 | Whitmore, Jansen & Callahan LLP (Allison Whitmore, David Kesselman)
Graystone University Medical Center | Lead Site (Site 001) | Dr. William Corwin, President | Dr. Catherine Aldridge, Global PI | 1200 University Avenue, Philadelphia, PA 19104
Lakemont Medical Center | Key Site (Site 002) | Dr. Howard Matsuoka, Co-PI | 4400 North Michigan Drive, Chicago, IL 60611
Meridian Contract Research Organization, Inc. | CRO (Approved Subcontractor) | Thomas Hartwell, CEO | 9200 Corporate Boulevard, Raleigh, NC 27615
Briarcliff Mutual Insurance Company | Clinical Trial Liability Insurer | Karen Tremblay, VP, Life Sciences Lines | 55 Constitution Plaza, Hartford, CT 06103
Pinnacle Data Solutions, Inc. | EDC Platform Vendor (Approved Subcontractor) | 6000 Clearwater Drive, San Diego, CA 92121
Northbridge Bioanalytical Laboratories, Inc. | Central Laboratory (Approved Subcontractor) | 2900 Commerce Way, Baltimore, MD 21224
Castleton & Hargrove LLP | FDA Regulatory Counsel to Penterra | Dr. Priya Sundaram, Esq. | 1100 Connecticut Avenue NW, Suite 900, Washington, DC 20036
Townsend Independent Auditors LLP | External Auditor to Penterra | Robert Chen, CPA | One Liberty Plaza, 22nd Floor, New York, NY 10006
Ridgeline Capital Markets LLC | Financial Advisor to Penterra | 383 Madison Avenue, 18th Floor, New York, NY 10179
[sheet: Conditions Precedent Detail]
CP No. | Condition Precedent | Required From | Required By | MCTA Section Reference | Evidence of Satisfaction | Date Satisfied | Status | Notes
1 | Delivery of Certificate of Insurance — Penterra clinical trial liability insurance (Briarcliff Mutual, Policy BM-CTL-2023-04182; $25M per occurrence / $75M aggregate; subject-injury sublimit $10M/$50M; additional insured endorsement for Veridian and sites) | Penterra / Briarcliff Mutual | Veridian | Exhibit E; MCTA §[Insurance] | Certificate of insurance and additional insured endorsement received by WJC via Calderwood & Harkness transmittal letter | 2023-07-02 | Satisfied | Policy period: April 1, 2023 – March 31, 2024
2 | Delivery of Certificates of Insurance — Lead Veridian Sites (general liability and professional liability: $5,000,000 per occurrence / $10,000,000 aggregate) for Graystone University Medical Center and Lakemont Medical Center | Veridian / Sites | Penterra | Exhibit E; MCTA §[Insurance] | Certificates received from Graystone and Lakemont | 2023-07-03 | Satisfied | Remaining 36 sites: certificates due within 15 business days of MCTA execution (by July 20, 2023)
3 | IRB Approval — Graystone University Institutional Review Board (IRB00012847) for Protocol PPC-4871-III at Graystone (Site 001) | Graystone IRB | Penterra / Veridian | MCTA §[IRB/Regulatory] | Copy of IRB approval letter received | 2023-06-30 | Satisfied | Individual IRB for Pennsylvania lead site
4 | IRB Approval — Veridian Central IRB for Protocol PPC-4871-III at Lakemont (Site 002) and non-Pennsylvania network sites | Veridian Central IRB | Penterra | MCTA §[IRB/Regulatory] | Copy of Central IRB approval letter received | 2023-07-01 | Satisfied | Covers non-PA sites under IRB authorization agreements
5 | Executed Investigator Signature Pages — Global PI (Dr. Catherine Aldridge) and Co-PI (Dr. Howard Matsuoka) | Investigators / Veridian | Penterra | MCTA §[Investigators] | Executed signature pages and investigator undertakings received | 2023-07-02 | Satisfied | Includes PI and Co-PI agreements
6 | Execution of all ancillary agreements: IP Side Letter, PI Agreement (Aldridge), Co-PI Agreement (Matsuoka), Individual Site Agreements (Sites 001–005) | All parties | All parties | MCTA §[Conditions Precedent] | All executed documents collected and confirmed | 2023-07-03 | Satisfied | IP Side Letter executed June 28, 2023 concurrently with MCTA
7 | Secretary's Certificates — Penterra and Veridian (board authorization, incumbency, organizational documents) | Penterra / Veridian | Counterparty | MCTA §[Conditions Precedent] | Secretary's certificates executed and exchanged | 2023-07-05 | Satisfied | Penterra: Delaware corp; Veridian: Delaware 501(c)(3)
8 | Closing Certificates — Penterra and Veridian (representations and warranties bringdown; performance of pre-closing obligations) | Penterra / Veridian | Counterparty | MCTA §[Conditions Precedent] | Closing certificates executed by Nathaniel Briggs (Penterra) and Dr. Franklin Osei (Veridian) | 2023-07-05 | Satisfied
9 | Officer's Certificate — Penterra (R&W bringdown true and correct in all material respects as of closing) | Penterra | Veridian | MCTA §[Conditions Precedent] | Officer's certificate executed | 2023-07-05 | Satisfied
10 | FDA Form 1572 — Filed for Dr. Catherine Aldridge and Dr. Howard Matsuoka under IND 157823 | Investigators / Penterra | Regulatory (FDA) | MCTA §[Regulatory]; 21 CFR 312 | Copies of completed Form 1572 received and filed with IND | 2023-07-02 | Satisfied
11 | Financial Disclosure Certifications (21 CFR Part 54) — Dr. Catherine Aldridge and Dr. Howard Matsuoka | Investigators | Penterra | MCTA §[Regulatory]; Exhibit H | Certifications received confirming absence/disclosure of relevant financial interests | 2023-07-01 | Satisfied