CONFIDENTIAL — SUBJECT TO ATTORNEY-CLIENT PRIVILEGE AND WORK PRODUCT DOCTRINE
June 16, 2023
Prepared by: Calderwood & Harkness LLP 280 Park Avenue, 34th Floor New York, NY 10017 Matter No. 1018-00004
Circulated to: Whitmore, Jansen & Callahan LLP 1500 Market Street, Suite 3200 Philadelphia, PA 19102 On behalf of Veridian Health Research Network, Inc.
NOTE TO COUNSEL: This Near-Final Draft reflects agreements reached at the in-person negotiation session held June 9, 2023, at the offices of Whitmore, Jansen & Callahan LLP, 1500 Market Street, Suite 3200, Philadelphia, PA 19102, and subsequent email exchanges between counsel (Calderwood & Harkness: Miriam Calloway, Sean Morrissey; WJC: Allison Whitmore, David Kesselman) through June 15, 2023. Bracketed provisions remain subject to final confirmation by the parties. All other previously bracketed provisions have been resolved and incorporated into this Near-Final Draft.
MASTER CLINICAL TRIAL AGREEMENT
NEAR-FINAL DRAFT
by and between
PENTERRA PHARMACEUTICALS CORP.
and
VERIDIAN HEALTH RESEARCH NETWORK, INC.
Dated as of [____], 2023
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MASTER CLINICAL TRIAL AGREEMENT
This Master Clinical Trial Agreement (this "MCTA" or "Agreement") is entered into as of [____], 2023 (the "Effective Date"), by and between:
PENTERRA PHARMACEUTICALS CORP., a Delaware corporation with its principal offices located at 200 Biopharma Boulevard, Suite 1400, Princeton, New Jersey 08540 (hereinafter referred to as the "Sponsor" or "Penterra");
and
VERIDIAN HEALTH RESEARCH NETWORK, INC., a Delaware corporation recognized as a tax-exempt organization under Section 501(c)(3) of the Internal Revenue Code of 1986, as amended, with its principal offices located at 750 Research Parkway, 8th Floor, Philadelphia, Pennsylvania 19104 (hereinafter referred to as the "Site Network" or "Veridian").
Each of Penterra and Veridian may be referred to herein individually as a "Party" and collectively as the "Parties."
RECITALS
WHEREAS, Penterra is a publicly traded specialty pharmaceutical company whose common stock is listed on the Nasdaq Stock Market under the ticker symbol "PTRA," engaged in the research, development, and commercialization of pharmaceutical products for the treatment of oncologic and other serious diseases;
WHEREAS, Penterra is the holder of Investigational New Drug Application No. 157823 ("IND 157823") filed with the United States Food and Drug Administration (the "FDA") for its investigational compound penterafenib, designated as PPC-4871, a next-generation oral multi-kinase inhibitor with demonstrated activity against multiple receptor tyrosine kinases implicated in the pathogenesis and progression of hepatocellular carcinoma;
WHEREAS, Penterra has successfully completed a Phase II clinical trial of penterafenib (PPC-4871) in patients with advanced hepatocellular carcinoma ("HCC"), which trial demonstrated a thirty-eight percent (38%) objective response rate ("ORR") in the intent-to-treat population, with Phase II completion occurring in January 2023, and Penterra has determined that penterafenib warrants further clinical evaluation in a Phase III registrational study;
WHEREAS, Penterra desires to conduct a Phase III, randomized, double-blind, placebo-controlled clinical trial designated as Protocol PPC-4871-III, titled "CLARION" (Clinical Assessment of Response with Longitudinal Investigation in ONcology), which trial has been registered at ClinicalTrials.gov under identifier NCT05928174, for the purpose of evaluating the efficacy and safety of penterafenib versus placebo in patients with advanced HCC who have received prior systemic therapy;
WHEREAS, Veridian operates a network of thirty-eight (38) academic medical centers and affiliated research institutions located across fourteen (14) states in the United States, with an annual research volume of approximately One Billion Four Hundred Million Dollars ($1,400,000,000), and maintains a robust infrastructure for the conduct of multi-center clinical trials in oncology and other therapeutic areas;
WHEREAS, Penterra desires to engage Veridian and its member institutions to serve as clinical trial sites for the CLARION trial, and Veridian desires to participate in the conduct of the CLARION trial at multiple sites within the Veridian Network, subject to the terms and conditions set forth herein;
WHEREAS, the Parties wish to set forth the terms and conditions governing the conduct of the CLARION trial at Veridian Network sites, including the obligations and responsibilities of each Party, financial terms providing for total compensation in the aggregate amount of Eighty Million Dollars ($80,000,000), indemnification provisions, intellectual property rights, confidentiality obligations, regulatory compliance requirements, and other matters related thereto;
NOW, THEREFORE, in consideration of the mutual covenants, representations, warranties, and agreements set forth herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:
ARTICLE I — DEFINITIONS
As used in this Agreement, the following terms shall have the meanings set forth below. Capitalized terms used but not defined in this Article I shall have the meanings ascribed to them elsewhere in this Agreement.
Section 1.1 "Affiliate" means, with respect to any Party, any entity that directly or indirectly controls, is controlled by, or is under common control with such Party. For purposes of this definition, "control" means the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of an entity, whether through the ownership of voting securities, by contract, or otherwise, including the ownership of fifty percent (50%) or more of the voting securities or other ownership interests of such entity.
Section 1.2 "Agreement" means this Master Clinical Trial Agreement, including all Exhibits, Schedules, and appendices attached hereto or incorporated herein by reference, as the same may be amended, modified, or supplemented from time to time in accordance with Section 15.6.
Section 1.3 "Applicable Law" means all applicable federal, state, and local laws, statutes, rules, regulations, ordinances, orders, decrees, guidelines, guidance documents, and directives, as the same may be in effect from time to time, including without limitation: (a) the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq.; (b) regulations promulgated by the FDA at 21 C.F.R. Part 11 (Electronic Records; Electronic Signatures), Part 50 (Protection of Human Subjects), Part 54 (Financial Disclosure by Clinical Investigators), Part 56 (Institutional Review Boards), and Part 312 (Investigational New Drug Application); (c) the ICH E6(R2) Guideline for Good Clinical Practice; (d) the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act ("HIPAA"), and implementing regulations at 45 C.F.R. Parts 160 and 164; (e) the Federal Anti-Kickback Statute, 42 U.S.C. § 1320a-7b; (f) the Physician Payments Sunshine Act, 42 U.S.C. § 1320a-7h, and implementing regulations at 42 C.F.R. Parts 402 and 403; (g) the Federal False Claims Act, 31 U.S.C. § 3729 et seq.; and (h) any applicable state clinical trial registration, reporting, or conduct requirements.
Section 1.4 "Briarcliff Policy" means Policy No. BM-CTL-2023-04182 issued by Briarcliff Mutual Insurance Company, 55 Constitution Plaza, Hartford, Connecticut 06103, providing clinical trial liability insurance coverage to Penterra, as more fully described in Article VIII and Exhibit E.
Section 1.5 "CLARION Trial" or "Study" means the Phase III, randomized, double-blind, placebo-controlled clinical trial of penterafenib (PPC-4871) versus placebo in subjects with advanced hepatocellular carcinoma who have received prior systemic therapy, conducted pursuant to the Protocol, as registered at ClinicalTrials.gov under identifier NCT05928174.
Section 1.6 "Closing Date" means the date on which all conditions precedent to the effectiveness of this Agreement have been satisfied or waived by the Party entitled to the benefit of such condition.
Section 1.7 "Confidential Information" means all information and data, whether oral, written, electronic, visual, or in any other form, that is disclosed by or on behalf of one Party (the "Disclosing Party") to the other Party (the "Receiving Party") in connection with this Agreement, including without limitation: (a) the Protocol and all Protocol-related information; (b) Investigational Product specifications, formulations, manufacturing processes, and preclinical and clinical data; (c) Study Data; (d) financial terms and payment information; (e) business plans, strategies, and proprietary methodologies; (f) patient and Subject information; (g) regulatory submissions and correspondence; and (h) the terms and conditions of this Agreement. Confidential Information does not include information that: (i) is or becomes publicly available through no fault of the Receiving Party; (ii) was rightfully in the Receiving Party's possession prior to disclosure, as demonstrated by contemporaneous written records; (iii) is independently developed by the Receiving Party without use of or reference to the Disclosing Party's Confidential Information; or (iv) is rightfully obtained by the Receiving Party from a third party without restriction on disclosure. Specific terms and conditions governing the treatment of Confidential Information are set forth in Article IX and Exhibit F.
Section 1.8 "CRO" means Meridian Contract Research Organization, Inc., a contract research organization separately engaged by Penterra pursuant to a Master Services Agreement dated January 15, 2023, to provide monitoring, data management, safety reporting, biostatistical analysis, and other clinical trial support services for the CLARION Trial.
Section 1.9 "EDC Platform" means the electronic data capture platform provided by Pinnacle Data Solutions, Inc. for the collection, management, and transfer of Study Data in connection with the CLARION Trial.
Section 1.10 "Effective Date" means the date on which all conditions precedent to this Agreement have been satisfied and this Agreement becomes operative, as set forth on the first page hereof.
Section 1.11 "First Patient In" or "FPI" means the date on which the first Subject is enrolled and randomized in the CLARION Trial at any Participating Site within the Veridian Network. The target date for First Patient In is August 14, 2023.
Section 1.12 "GCP" means Good Clinical Practice as defined by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ("ICH") Guideline E6(R2), as adopted by the FDA and as may be amended from time to time.
Section 1.13 "Global Principal Investigator" means Dr. Catherine Aldridge, M.D., Ph.D., Professor of Oncology at Graystone University Medical Center, who has been designated by Penterra and Veridian to serve as the lead investigator for the CLARION Trial across all Participating Sites.
Section 1.14 "IND" means Investigational New Drug Application No. 157823, as filed by Penterra with the FDA for penterafenib (PPC-4871) and as amended from time to time.
Section 1.15 "Individual Site Agreement" means the joinder agreement to be executed by each Participating Site substantially in the form attached hereto as Exhibit C, pursuant to which each Participating Site agrees to be bound by the terms and conditions of this Agreement and the Protocol with respect to the conduct of the CLARION Trial at such Participating Site.
Section 1.16 "Investigational Product" means penterafenib (PPC-4871), a next-generation oral multi-kinase inhibitor, and matching placebo, as manufactured, labeled, and supplied by Penterra for use in the CLARION Trial in accordance with the Protocol.
Section 1.17 "Investigator" means each qualified physician designated as a principal investigator or sub-investigator at a Participating Site, who has been delegated responsibility for the conduct of the CLARION Trial at such Site and who has executed a Form FDA 1572 (Statement of Investigator) and an Investigator Undertaking in the form of Exhibit I.
Section 1.18 "IRB" means an Institutional Review Board constituted and operating in accordance with 21 C.F.R. Part 56 and applicable OHRP requirements, including the Graystone University Institutional Review Board (IRB Registration: IRB00012847) and the Veridian Central IRB, or any other IRB with jurisdiction over a Participating Site as applicable.
Section 1.19 "Participating Site" or "Site" means each academic medical center or affiliated research institution within the Veridian Network that has executed an Individual Site Agreement in the form of Exhibit C and has been activated for participation in the CLARION Trial, as listed in Schedule 1.
Section 1.20 "Protocol" means Protocol PPC-4871-III (CLARION), including the protocol synopsis attached hereto as Exhibit A, as the same may be amended, modified, or supplemented from time to time with the written approval of Penterra and the applicable IRB.
Section 1.21 "SAE" means a serious adverse event, as defined in 21 C.F.R. § 312.32 and the ICH E6(R2) Guideline, including any adverse event that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is a medically important event that may jeopardize the Subject and may require medical or surgical intervention to prevent one of the other outcomes listed herein.
Section 1.22 "Site Network" means Veridian Health Research Network, Inc.
Section 1.23 "Site Personnel" means all investigators, sub-investigators, study coordinators, research nurses, clinical research associates, data entry personnel, laboratory personnel, pharmacists, and other staff at a Participating Site who are involved in the conduct of the CLARION Trial at such Site.
Section 1.24 "Sponsor" means Penterra Pharmaceuticals Corp.
Section 1.25 "Study Data" means all data, information, results, analyses, records, reports, case report forms, source documents, laboratory results, imaging data, pharmacokinetic data, pharmacodynamic data, biomarker data, safety data, efficacy data, and all other data and information generated, collected, compiled, or derived in connection with the conduct of the CLARION Trial at any Participating Site, whether in electronic or paper form.
Section 1.26 "Subject" means a human research participant who has provided informed consent and has been enrolled in the CLARION Trial at a Participating Site in accordance with the Protocol and applicable regulatory requirements.
Section 1.27 "Subject Injury" means any bodily injury, illness, disease, or adverse health consequence sustained by a Subject as a direct result of the Subject's participation in the CLARION Trial, including but not limited to injuries resulting from the administration of the Investigational Product or the performance of Protocol-required procedures.
Section 1.28 "Veridian Network" means the collective group of thirty-eight (38) academic medical centers and affiliated research institutions located across fourteen (14) states that are operated by or affiliated with Veridian Health Research Network, Inc., as listed in Schedule 1.
ARTICLE II — SCOPE OF AGREEMENT
Section 2.1 — Purpose. Penterra hereby engages Veridian, and Veridian hereby agrees, to coordinate and facilitate the conduct of the CLARION Trial across the Veridian Network in accordance with the terms and conditions set forth in this Agreement. The CLARION Trial is a Phase III, randomized, double-blind, placebo-controlled study of penterafenib (PPC-4871) versus placebo in patients with advanced hepatocellular carcinoma who have received prior systemic therapy. The planned enrollment for the CLARION Trial is twelve hundred (1,200) Subjects, who will be randomized in a 2:1 ratio (eight hundred (800) Subjects to the penterafenib arm and four hundred (400) Subjects to the placebo arm). The CLARION Trial will be conducted at thirty-eight (38) Participating Sites located across fourteen (14) states within the Veridian Network, as identified in Schedule 1 attached hereto. The projected enrollment period is forty-two (42) months from First Patient In. The estimated total study duration, including the enrollment period and the post-enrollment follow-up period, is sixty (60) months (forty-two (42) months of enrollment plus eighteen (18) months of follow-up). The primary endpoint of the CLARION Trial is overall survival ("OS"). Key secondary endpoints include progression-free survival ("PFS"), objective response rate ("ORR"), and duration of response ("DOR"). The full protocol synopsis for the CLARION Trial is attached hereto as Exhibit A.
Section 2.2 — Site Participation Structure. Each Participating Site within the Veridian Network that wishes to participate in the CLARION Trial shall execute an Individual Site Agreement substantially in the form attached hereto as Exhibit C. Each Individual Site Agreement shall incorporate the terms and conditions of this Agreement by reference and shall set forth any site-specific terms, including the identity of the principal investigator and key study personnel at such Site. Two sites have been designated as lead sites for the CLARION Trial: (a) Graystone University Medical Center, located in Philadelphia, Pennsylvania (designated as Site 001), and (b) Lakemont Medical Center, located in Chicago, Illinois (designated as Site 002). The Global Principal Investigator for the CLARION Trial is Dr. Catherine Aldridge, M.D., Ph.D., Professor of Oncology at Graystone University Medical Center. The Co-Principal Investigator for the CLARION Trial is Dr. Howard Matsuoka, M.D., of the Department of Medical Oncology at Lakemont Medical Center. The Global Principal Investigator and Co-Principal Investigator shall have the responsibilities set forth in the Protocol and in their respective Investigator Undertakings executed in the form of Exhibit I.
Section 2.3 — Role of Veridian Central Administration. Veridian shall serve as the coordinating entity for network-wide administrative, regulatory, and operational functions in connection with the CLARION Trial. In this capacity, Veridian shall be responsible for: (a) facilitating the execution of Individual Site Agreements with each Participating Site; (b) coordinating and facilitating IRB approvals across the Veridian Network, including management of the Veridian Central IRB and execution of IRB Authorization Agreements as applicable; (c) facilitating site activation procedures across the Veridian Network; (d) serving as the primary point of contact for network-wide communication between Penterra (and its CRO, Meridian Contract Research Organization, Inc.) and the Participating Sites; (e) coordinating the distribution of study materials, training schedules, and operational updates across the Veridian Network; and (f) providing centralized administrative support for invoicing and financial management on behalf of the Participating Sites in accordance with Article IV. Notwithstanding the foregoing, Veridian shall not be responsible for the clinical conduct of the Study at individual Participating Sites except as specifically set forth in this Agreement, and each Participating Site and its Investigators shall bear direct responsibility for the conduct of the Study at their respective Sites in accordance with the Protocol, GCP, and Applicable Law.
Section 2.4 — Third-Party Service Providers. Penterra has separately engaged the following third-party service providers in connection with the conduct of the CLARION Trial, as more fully described in Exhibit K:
(a) Meridian Contract Research Organization, Inc. ("CRO") — Penterra has engaged Meridian CRO pursuant to a Master Services Agreement dated January 15, 2023, to provide clinical trial monitoring services, data management, safety reporting and pharmacovigilance services, and biostatistical analysis for the CLARION Trial. Meridian CRO will serve as the primary monitoring organization for the CLARION Trial and will conduct site monitoring visits at each Participating Site in accordance with the monitoring plan.
(b) Pinnacle Data Solutions, Inc. — Penterra has engaged Pinnacle Data Solutions, Inc. to provide the electronic data capture platform (the "EDC Platform") for the collection, management, and transfer of Study Data. Veridian and each Participating Site shall utilize the Pinnacle EDC Platform for all data entry, query resolution, and data management activities in connection with the CLARION Trial.
(c) Northbridge Bioanalytical Laboratories, Inc. — Penterra has engaged Northbridge Bioanalytical Laboratories, Inc. to provide central laboratory services for the CLARION Trial, including pharmacokinetic ("PK") and pharmacodynamic ("PD") analyses, biomarker analyses, and safety laboratory analyses.
Veridian and each Participating Site shall cooperate fully with each of the foregoing approved subcontractors in connection with the conduct of the CLARION Trial, including by providing such subcontractors with access to Participating Sites, study records, source documents, and facilities as reasonably necessary for the performance of their respective obligations. The engagement of these third-party service providers does not relieve Penterra of its obligations under this Agreement or under Applicable Law.
Section 2.5 — Protocol Compliance. All Study activities conducted at each Participating Site shall be performed in strict accordance with the Protocol (as set forth in Exhibit A), GCP (ICH E6(R2)), and all Applicable Law. No deviation from the Protocol shall be made without the prior written approval of Penterra, except where such deviation is necessary to protect the immediate safety, rights, or welfare of a Subject, in which case the provisions of Section 7.4 shall apply. Any amendment to the Protocol shall require the prior written approval of Penterra and the approval of the applicable IRB before implementation at any Participating Site.
ARTICLE III — IRB AND REGULATORY APPROVALS
Section 3.1 — IRB Approval Required Prior to Enrollment. No Subject may be enrolled or randomized at any Participating Site until such Participating Site has obtained written approval from the applicable IRB for the Protocol, the informed consent form, and all other study documents requiring IRB approval in accordance with 21 C.F.R. Part 56 and applicable institutional policies. The lead sites shall obtain IRB approval as follows:
(a) Graystone University Medical Center (Site 001): IRB approval shall be obtained from the Graystone University Institutional Review Board, which is registered with the Office for Human Research Protections under IRB Registration Number IRB00012847.
(b) Lakemont Medical Center (Site 002): IRB approval shall be obtained from the Veridian Central IRB.
The remaining Participating Sites within the Veridian Network may rely on the Veridian Central IRB pursuant to IRB Authorization Agreements executed in accordance with the revised Common Rule (45 C.F.R. Part 46, as amended effective January 19, 2018) and 21 C.F.R. Part 56, provided that each such Participating Site executes an appropriate IRB Authorization Agreement and complies with all local institutional requirements. Veridian shall coordinate the execution of all necessary IRB Authorization Agreements and shall provide copies of such agreements to Penterra upon request.
Section 3.2 — IND Maintenance. Penterra, as the holder of IND 157823 for penterafenib (PPC-4871), shall be solely responsible for all aspects of IND maintenance, including the submission of IND amendments, annual reports, safety reports, and other required submissions to the FDA in accordance with 21 C.F.R. Part 312. Each Participating Site and each Investigator shall provide Penterra with all information, data, reports, and cooperation reasonably necessary to enable Penterra to comply with its IND maintenance obligations, including but not limited to financial disclosure information pursuant to 21 C.F.R. Part 54, investigator qualification information, and safety data.
Section 3.3 — Regulatory Inspections. Each Participating Site shall permit and facilitate inspections by the FDA and other applicable regulatory authorities, as well as monitoring and audit visits by Penterra, Meridian CRO, and their authorized representatives, in connection with the CLARION Trial. Each Participating Site shall promptly notify Penterra, and Veridian shall promptly notify Penterra, of any inquiry, inspection, investigation, or enforcement action by any regulatory authority related to or potentially affecting the CLARION Trial, including but not limited to FDA Form 483 observations, Warning Letters, untitled letters, and any other correspondence from regulatory authorities. Such notification shall be provided in writing within five (5) business days of the Participating Site's or Veridian's receipt of such inquiry, inspection notice, or correspondence.
Section 3.4 — Safety Reporting. Detailed safety reporting procedures for the CLARION Trial are set forth in Exhibit J. Without limiting the provisions of Exhibit J, the Parties agree to the following:
(a) SAE Reporting by Sites: Each Participating Site and each Investigator shall report all SAEs to Penterra and to Meridian CRO within twenty-four (24) hours of becoming aware of the SAE. SAE reports shall be submitted in the format and through the channels specified in Exhibit J and shall include all available information regarding the SAE, including the identity of the Subject (by study identification number), the nature and severity of the event, the date of onset, the relationship to the Investigational Product as assessed by the Investigator, and the outcome of the event.
(b) IND Safety Reports by Sponsor: Penterra, as IND holder, shall be responsible for the preparation and submission of IND safety reports to the FDA in accordance with 21 C.F.R. § 312.32, including: (i) seven (7)-calendar-day reports for fatal or life-threatening suspected adverse reactions that are both unexpected and associated with the use of the Investigational Product; and (ii) fifteen (15)-calendar-day reports for all other reportable events meeting the criteria for IND safety reporting.
(c) Coordination with CRO: Penterra and Meridian CRO shall coordinate the receipt, processing, assessment, and reporting of safety data from all Participating Sites in accordance with the safety reporting procedures set forth in Exhibit J. Penterra shall ensure that Meridian CRO is equipped with the necessary systems, personnel, and processes to carry out these functions in a timely and compliant manner.
ARTICLE IV — FINANCIAL TERMS
Section 4.1 — Total Compensation. The total compensation to be paid by Penterra to Veridian and the Participating Sites under this Agreement for the conduct of the CLARION Trial across all Veridian Network sites over the projected life of the Study shall not exceed Eighty Million Dollars ($80,000,000) (the "Total Deal Value"), subject to the component breakdown and payment schedule set forth in this Article IV and in the detailed budget attached as Exhibit B. All amounts stated in this Article IV are denominated in United States Dollars.
Section 4.2 — Component Breakdown. The Total Deal Value of Eighty Million Dollars ($80,000,000) is comprised of the following components:
(a) Per-Patient Site Fees (Screen-to-Completion): Fifty-Two Thousand Dollars ($52,000) per Subject for each of the twelve hundred (1,200) planned Subjects from screening through study completion, for an aggregate amount of Sixty-Two Million Four Hundred Thousand Dollars ($62,400,000). Per-patient site fees are intended to compensate each Participating Site for the clinical conduct of the Study at such Site, including subject screening, enrollment, randomization, treatment administration, study visits, assessments, data collection and entry, source document preparation and maintenance, and all other Protocol-required activities performed at the Site level.
(b) Start-Up Fees: Seventy-Five Thousand Dollars ($75,000) per Participating Site for each of the thirty-eight (38) planned Participating Sites, for an aggregate amount of Two Million Eight Hundred Fifty Thousand Dollars ($2,850,000). Start-up fees are intended to compensate each Participating Site for site activation costs, including regulatory and IRB preparation, study file establishment, staff training, facility preparation, and equipment calibration.
(c) Annual Site Maintenance Fees: Forty Thousand Dollars ($40,000) per Participating Site per year for each of the thirty-eight (38) Participating Sites over an average period of three and one-half (3.5) years, for an aggregate amount of Five Million Three Hundred Twenty Thousand Dollars ($5,320,000). Annual site maintenance fees are intended to compensate each Participating Site for ongoing operational costs associated with maintaining the Site's readiness and compliance throughout the duration of the Study, including IRB continuing review submissions, regulatory file maintenance, and staff retention.
(d) Investigator Grants (Publication and Academic Support): An aggregate amount of One Million Five Hundred Thousand Dollars ($1,500,000), to be disbursed to Investigators for the support of academic research activities and the preparation and publication of manuscripts related to the CLARION Trial, in accordance with Section 10.5 and Exhibit G.
(e) Network Coordination/Administrative Fee to Veridian Central: An aggregate amount of Four Million Two Hundred Thousand Dollars ($4,200,000), to compensate Veridian for its centralized administrative, regulatory, and operational coordination functions as described in Section 2.3.
(f) Technology/EDC Integration Costs: An aggregate amount of One Million Two Hundred Thirty Thousand Dollars ($1,230,000) for the integration, configuration, validation, and ongoing maintenance of the Pinnacle EDC Platform across all Participating Sites within the Veridian Network, including site-level training and user support.
(g) Contingency/Change Order Reserve: An aggregate amount of Two Million Five Hundred Thousand Dollars ($2,500,000), to be held in reserve by Penterra and disbursed only upon mutual written agreement of the Parties for costs arising from Protocol amendments, unanticipated regulatory requirements, change orders, or other unforeseen circumstances requiring additional expenditure. Any unused portion of the contingency/change order reserve shall not be owed by Penterra and shall remain unearned.
Section 4.3 — Payment Milestones and Schedule. Payments under this Agreement shall be made in accordance with the following milestone-based payment schedule:
(a) Start-Up Fees: Start-up fees of Seventy-Five Thousand Dollars ($75,000) per Participating Site shall be paid in two equal installments:
(i) Fifty percent (50%) of the start-up fee (Thirty-Seven Thousand Five Hundred Dollars ($37,500)) shall be payable upon site activation, which shall be deemed to occur upon completion of site initiation visit, IRB approval, and execution of the Individual Site Agreement for such Site; and
(ii) Fifty percent (50%) of the start-up fee (Thirty-Seven Thousand Five Hundred Dollars ($37,500)) shall be payable upon the first Subject enrolled at such Participating Site.
(b) Per-Patient Site Fees: Per-patient site fees of Fifty-Two Thousand Dollars ($52,000) per Subject shall be paid in four (4) equal milestone-based installments of Thirteen Thousand Dollars ($13,000) each, as follows:
(i) Twenty-five percent (25%) (Thirteen Thousand Dollars ($13,000)) at randomization of the Subject;
(ii) Twenty-five percent (25%) (Thirteen Thousand Dollars ($13,000)) upon completion of the Week 12 assessment for such Subject;
(iii) Twenty-five percent (25%) (Thirteen Thousand Dollars ($13,000)) upon completion of the Week 24 assessment for such Subject; and
(iv) Twenty-five percent (25%) (Thirteen Thousand Dollars ($13,000)) upon study completion or final visit for such Subject, as defined in the Protocol.
(c) Network Coordination/Administrative Fee: The network coordination/administrative fee of Four Million Two Hundred Thousand Dollars ($4,200,000) shall be paid in fourteen (14) quarterly installments of Three Hundred Thousand Dollars ($300,000) each, commencing on the first quarterly anniversary of the Effective Date and continuing on each subsequent quarterly anniversary thereafter until the full amount has been paid.
(d) Annual Site Maintenance Fees: Annual site maintenance fees of Forty Thousand Dollars ($40,000) per Participating Site shall be paid annually in advance on each anniversary of the date of site activation for such Participating Site, commencing on the first anniversary of site activation.
(e) Investigator Grants: Investigator grants shall be disbursed upon acceptance of manuscripts for publication in peer-reviewed journals, in accordance with the terms set forth in Section 10.5 and Exhibit G. Individual grant amounts shall be determined by Penterra in consultation with the Global Principal Investigator based on the scope and significance of the publication.
(f) Technology/EDC Integration Costs: Technology and EDC integration costs of One Million Two Hundred Thirty Thousand Dollars ($1,230,000) shall be paid in accordance with the separate payment schedule set forth in Exhibit B.
Section 4.4 — Payment Terms. All payments under this Agreement shall be due and payable within forty-five (45) calendar days from the date of receipt by Penterra of a proper invoice (the "Payment Period"). Invoices shall be submitted by Veridian on behalf of the Participating Sites to Penterra's clinical contracts department, attention: Samantha Novak, Director, Clinical Contracts, at 200 Biopharma Boulevard, Suite 1400, Princeton, New Jersey 08540, or such other address or electronic invoicing portal as Penterra may designate in writing from time to time. Each invoice shall include: (a) the name and site identification number of the applicable Participating Site; (b) the applicable milestone or payment trigger; (c) the Subject identification number (for per-patient fees); (d) the amount due; and (e) such supporting documentation as Penterra may reasonably require. In the event that Penterra disputes any portion of an invoice, Penterra shall pay all undisputed portions of such invoice within the Payment Period, and the disputed amounts shall be resolved in accordance with Section 4.5.
Section 4.5 — Invoice Disputes. In the event that Penterra disputes any amount set forth in an invoice submitted by Veridian, Penterra shall provide Veridian with written notice of such dispute within fifteen (15) business days of receipt of the invoice. Such notice shall specify in reasonable detail the nature and basis of the dispute and the amount in dispute. The Parties shall endeavor in good faith to resolve any invoice dispute within thirty (30) calendar days of the date of Penterra's dispute notice. If the dispute is not resolved within such thirty (30)-day period, the dispute shall be escalated to the designated representatives identified in Section 14.3 for resolution in accordance with the escalation procedures set forth in Article XIV.
Section 4.6 — Fair Market Value; Regulatory Compliance. The Parties acknowledge and agree that all payments to be made under this Agreement represent fair market value for the services to be rendered and the obligations to be performed by Veridian, the Participating Sites, and the Investigators hereunder. All payments under this Agreement have been structured in compliance with the applicable safe harbor requirements of the Federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b), including the safe harbor for personal services and management contracts set forth at 42 C.F.R. § 1001.952(d). The Parties further acknowledge and agree that all applicable payments to Investigators and institutions under this Agreement shall be reported by Penterra in accordance with the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h) and the Open Payments program, and Veridian and the Investigators shall cooperate in providing all information necessary for such reporting. All Investigators shall comply with the financial disclosure requirements of 21 C.F.R. Part 54, and shall complete and submit financial disclosure certifications in the form set forth in Exhibit I.
Section 4.7 — Taxes. Each Party shall be responsible for the payment of any and all taxes, assessments, duties, or other governmental charges imposed on such Party in connection with this Agreement or the payments made hereunder. Veridian, as a tax-exempt organization recognized under Section 501(c)(3) of the Internal Revenue Code (Employer Identification Number: 23-4178205), shall provide Penterra with evidence of its tax-exempt status, including a copy of its IRS determination letter, within fifteen (15) business days of execution of this Agreement. To the extent that any payment under this Agreement is subject to withholding tax or other deduction required by Applicable Law, the paying Party shall deduct and withhold such amount and remit it to the appropriate taxing authority, and the net amount after such withholding shall be deemed to constitute full payment of the applicable obligation.
ARTICLE V — OBLIGATIONS OF THE SPONSOR
Section 5.1 — Supply of Investigational Product. Penterra shall supply penterafenib (PPC-4871) and matching placebo to each Participating Site in quantities sufficient for the conduct of the CLARION Trial at no cost to the Participating Sites or to the Subjects. Penterra shall be solely responsible for the manufacturing, quality control, labeling, packaging, and shipping of the Investigational Product in accordance with current good manufacturing practice ("cGMP") regulations (21 C.F.R. Parts 210 and 211) and the specifications set forth in the Protocol and the Investigator's Brochure. Drug accountability procedures shall be conducted at each Participating Site in accordance with the Protocol, GCP, and 21 C.F.R. § 312.62. Penterra shall ensure that adequate supplies of the Investigational Product are available at each Participating Site throughout the enrollment and treatment periods of the CLARION Trial, and shall use commercially reasonable efforts to avoid any interruption in the supply of the Investigational Product.
Section 5.2 — Protocol and Study Documents. Penterra shall provide Veridian and each Participating Site with: (a) Protocol PPC-4871-III (CLARION), including any amendments thereto; (b) the current Investigator's Brochure for penterafenib (PPC-4871), including any updates thereto; (c) electronic case report forms ("eCRFs") via the Pinnacle EDC Platform; (d) a template informed consent form for adaptation by each Participating Site in accordance with local IRB requirements; (e) randomization instructions and interactive response technology ("IRT") access; and (f) all other study documents, forms, and materials required for the conduct of the CLARION Trial. Penterra shall provide updated versions of all study documents to Veridian and the Participating Sites in a timely manner following any amendment or revision.
Section 5.3 — Monitoring. Penterra, through Meridian CRO, shall conduct site monitoring visits at each Participating Site in accordance with GCP and the monitoring plan developed for the CLARION Trial. Site monitoring visits shall include, without limitation: (a) source document verification; (b) verification of informed consent documentation; (c) drug accountability reconciliation; (d) review of regulatory files; (e) data query generation and resolution; and (f) assessment of compliance with the Protocol, GCP, and Applicable Law. The frequency of monitoring visits shall be determined by the monitoring plan, taking into account enrollment rates, data quality, and regulatory requirements. Penterra shall ensure that all clinical research associates ("CRAs") assigned to monitor the CLARION Trial are appropriately trained and qualified.
Section 5.4 — Regulatory Submissions. Penterra shall be responsible for all regulatory submissions to the FDA in connection with the CLARION Trial, including without limitation IND amendments, protocol amendments, IND safety reports (as described in Section 3.4), IND annual reports, and all other submissions required under 21 C.F.R. Part 312. Penterra shall provide copies of relevant regulatory correspondence to Veridian upon Veridian's reasonable written request, subject to redaction of commercially sensitive information not relevant to Veridian's or the Participating Sites' obligations under this Agreement.
Section 5.5 — Insurance. Penterra shall obtain and maintain clinical trial liability insurance coverage throughout the term of this Agreement and for a period of [2] years following Study completion, as more fully described in Article VIII. Penterra shall comply with the insurance requirements set forth in Article VIII and Exhibit E, including the obligation to name Veridian and each Participating Site as additional insureds under the Briarcliff Policy.
Section 5.6 — Training. Penterra and Meridian CRO shall provide comprehensive training to Investigators and Site Personnel in connection with the CLARION Trial, including: (a) an investigator meeting to be held prior to First Patient In, at which the Protocol, study procedures, safety reporting requirements, EDC Platform operation, and regulatory requirements shall be reviewed; (b) site initiation visits at each Participating Site prior to site activation; and (c) ongoing training as reasonably necessary throughout the conduct of the Study, including training on Protocol amendments, changes in study procedures, and updates to regulatory requirements. All training materials shall be provided by Penterra at no cost to Veridian or the Participating Sites.
ARTICLE VI — OBLIGATIONS OF VERIDIAN AND PARTICIPATING SITES
Section 6.1 — Conduct of the Study. Each Participating Site shall conduct the CLARION Trial in accordance with the Protocol, GCP (ICH E6(R2)), IRB requirements, and all Applicable Law. Each Participating Site shall enroll Subjects in accordance with the inclusion and exclusion criteria set forth in the Protocol and shall not enroll any Subject who does not meet such criteria. Each Participating Site shall ensure that all Study activities performed at such Site, including Subject screening, enrollment, randomization, treatment administration, study visits, assessments, laboratory sample collection and processing, data collection and entry, adverse event reporting, and all other Protocol-required procedures, are conducted by qualified Site Personnel in accordance with the Protocol and any written instructions provided by Penterra or Meridian CRO.
Section 6.2 — Investigator Qualifications. Each principal investigator at a Participating Site shall: (a) execute a completed Form FDA 1572 (Statement of Investigator) in accordance with 21 C.F.R. § 312.53; (b) execute an Investigator Undertaking in the form attached hereto as Exhibit I; and (c) complete and submit a financial disclosure certification in accordance with 21 C.F.R. Part 54 and the Financial Disclosure Template attached to Exhibit I. Each principal investigator shall be a qualified physician licensed to practice medicine in the state in which the Participating Site is located and shall have appropriate training, expertise, and experience in the conduct of clinical trials in oncology. Financial disclosures pursuant to 21 C.F.R. Part 54 shall be required from all Investigators (including sub-investigators) and shall be submitted to Penterra prior to the initiation of Study activities at such Site and updated annually and at the conclusion of the Study.
Section 6.3 — Records and Source Documentation. Each Participating Site shall prepare, maintain, and retain complete and accurate source documents and study records for each Subject enrolled at such Site, in accordance with GCP, 21 C.F.R. § 312.62, and applicable institutional policies. Source documents shall include, without limitation, medical records, hospital charts, laboratory reports, imaging reports, pharmacy records, Subject diaries, informed consent documents, and any other original documents supporting the data entered into the eCRFs on the Pinnacle EDC Platform. All study records shall be retained by each Participating Site for a minimum period of fifteen (15) years following the completion or termination of the Study, or for such longer period as may be required by Applicable Law or institutional policy, whichever is longer. No Participating Site shall destroy any study records without obtaining the prior written consent of Penterra.
Section 6.4 — Access and Monitoring. Each Participating Site shall provide Penterra, Meridian CRO, and their authorized representatives with reasonable access to study records, source documents, and facilities at such Participating Site for the purposes of: (a) monitoring visits conducted in accordance with the monitoring plan; (b) audits conducted by or on behalf of Penterra; (c) inspections by the FDA or other applicable regulatory authorities; and (d) any other purpose reasonably related to ensuring the quality, integrity, and compliance of the Study. Such access shall be provided at reasonable times during normal business hours and upon reasonable prior notice, except that immediate access shall be provided in the event of an FDA inspection or other regulatory authority inquiry.
Section 6.5 — Enrollment Commitments. [Parties to confirm whether enrollment minimums or site-specific enrollment targets will be included in the MCTA or addressed solely in Individual Site Agreements. Proposed resolution: Enrollment minimums and site-specific enrollment targets shall be addressed in the Individual Site Agreements and shall not be set forth in this Agreement.] Veridian shall use commercially reasonable efforts to facilitate enrollment across the Veridian Network to achieve the planned enrollment target of twelve hundred (1,200) Subjects within the projected forty-two (42)-month enrollment period. Veridian shall report enrollment progress to Penterra on a monthly basis and shall cooperate with Penterra and Meridian CRO in the development and implementation of enrollment enhancement strategies as may be reasonably necessary.
Section 6.6 — Staffing. Veridian and each Participating Site shall be responsible for ensuring that adequate qualified staffing is maintained at each Site throughout the duration of the Study, including principal investigators, sub-investigators, study coordinators, research nurses, data entry personnel, regulatory personnel, and pharmacists as applicable. Each Participating Site shall promptly notify Penterra in writing of any change in the principal investigator or other key study personnel at such Site, including a change in the principal investigator due to departure, disability, death, or other cause. In the event of a change in principal investigator, the replacement investigator shall execute a new Form FDA 1572, Investigator Undertaking, and financial disclosure certification prior to assuming responsibility for the Study at such Site, and such change shall be approved by Penterra and the applicable IRB.
Section 6.7 — Compliance with HIPAA. Each Participating Site shall obtain appropriate research authorizations from Subjects in accordance with the HIPAA Privacy Rule (45 C.F.R. Part 164, Subpart E), or shall obtain an IRB-approved waiver of authorization as permitted under 45 C.F.R. § 164.512(i), prior to the use or disclosure of individually identifiable health information ("PHI") in connection with the CLARION Trial. Each Participating Site shall comply with the HIPAA minimum necessary standard in all uses and disclosures of PHI and shall implement appropriate administrative, technical, and physical safeguards to protect the privacy and security of PHI in accordance with the HIPAA Security Rule (45 C.F.R. Part 164, Subpart C). Any sharing of PHI with Penterra, Meridian CRO, Pinnacle Data Solutions, or any other entity shall be conducted in accordance with HIPAA and the detailed data protection provisions set forth in Exhibit F, including the execution of business associate agreements as necessary.
ARTICLE VII — INDEMNIFICATION
Section 7.1 — Sponsor Indemnification of Site Network, Sites, and Investigators. Penterra shall indemnify, defend, and hold harmless Veridian, each Participating Site institution, each principal investigator, each sub-investigator, and each member of Site Personnel involved in the conduct of the CLARION Trial (collectively, the "Site Indemnitees"), and their respective officers, directors, trustees, employees, agents, and successors, from and against any and all claims, demands, actions, suits, losses, damages, liabilities, judgments, settlements, penalties, fines, costs, and expenses (including reasonable attorneys' fees and costs of litigation or arbitration) (collectively, "Losses") arising from or related to:
(a) Any Subject Injury caused by the Investigational Product (penterafenib, PPC-4871) when administered to a Subject in accordance with the Protocol and the instructions of the Sponsor;
(b) Any defect in the Investigational Product, including without limitation any defect in the manufacturing, formulation, compounding, labeling, packaging, storage, or shipping of the Investigational Product;
(c) Any breach by Penterra of its obligations, representations, warranties, or covenants under this Agreement or the Protocol; or
(d) Any negligence or willful misconduct of Penterra or its employees, agents, or representatives (including Meridian CRO and its personnel) in connection with the conduct of the CLARION Trial.
The indemnification obligations of Penterra under subsection (b) of this Section 7.1 with respect to product-defect claims shall not be subject to any per-occurrence or aggregate cap.
Section 7.2 — Carve-Outs from Sponsor Indemnification. Penterra's indemnification obligations under Section 7.1 shall not extend to Losses to the extent arising from or attributable to:
(i) The negligence, recklessness, or willful misconduct of any Site Indemnitee, including any Participating Site, any Investigator, or any member of Site Personnel;
(ii) Any deviation from the Protocol by an Investigator or Site Personnel that is not authorized by Penterra in writing and is not a medically necessary deviation covered by Section 7.4; or
(iii) Any breach by Veridian, a Participating Site, an Investigator, or Site Personnel of their respective obligations under this Agreement or Applicable Law.
To the extent that Losses are attributable to the concurrent fault of both Penterra and one or more Site Indemnitees, liability shall be apportioned according to the relative fault of each Party.
Section 7.3 — Subject Medical Care Costs. Without limiting the generality of Section 7.1, Penterra agrees to cover the reasonable and customary medical costs for the treatment of Study-related injuries sustained by Subjects in connection with the CLARION Trial, to the extent such costs are not covered by the Subject's own medical insurance or other third-party payment sources. Coverage of medical costs under this Section 7.3 shall be subject to the following limitations:
(a) Per-Subject Cap: Penterra's obligation to cover medical costs under this Section 7.3 shall not exceed Five Hundred Thousand Dollars ($500,000) per Subject per occurrence.
(b) Aggregate Cap: Penterra's aggregate obligation to cover medical costs under this Section 7.3 across all Subjects at all Participating Sites shall not exceed Fifteen Million Dollars ($15,000,000).
(c) Determination of Study-Related Injury: The determination of whether an injury constitutes a "Study-related injury" for purposes of this Section 7.3 shall be based on the reasonable medical judgment of the treating physician at the Participating Site. In the event that Penterra disputes such determination, the Parties shall submit the matter to an independent medical expert mutually agreed upon by the Parties (or, if the Parties cannot agree, appointed by the American Arbitration Association) for a binding determination.
Section 7.4 — Medically Necessary Protocol Deviations. In the event that an Investigator deviates from the Protocol as reasonably necessary to protect the immediate safety, rights, or welfare of a Subject, such deviation shall not be deemed a carve-out from Penterra's indemnification obligations under Section 7.2(ii), and Penterra's indemnification obligations under Section 7.1 shall apply to Losses arising from such deviation, provided that the following conditions are satisfied:
(a) The Investigator notifies Penterra (or Meridian CRO on Penterra's behalf) of the deviation in writing within twenty-four (24) hours of the occurrence of the deviation;
(b) The deviation is contemporaneously documented in the Subject's medical record and is reported to the applicable IRB in accordance with applicable regulations and institutional policies; and
(c) The deviation is consistent with reasonable medical judgment under the circumstances then prevailing, as determined by the standard of care applicable to the treatment of the Subject's condition.
Nothing in this Section 7.4 shall relieve a Participating Site, an Investigator, or Site Personnel of responsibility for protocol deviations that do not satisfy the conditions set forth above.
Section 7.5 — Site/Investigator Indemnification of Sponsor. Veridian and each Participating Site institution (pursuant to the applicable Individual Site Agreement) shall indemnify, defend, and hold harmless Penterra and its officers, directors, employees, agents, and representatives (collectively, the "Sponsor Indemnitees") from and against any and all Losses arising from or related to:
(a) The negligence, recklessness, or willful misconduct of any Investigator or Site Personnel in connection with the conduct of the CLARION Trial;
(b) Protocol deviations by Investigators or Site Personnel that are not authorized by Penterra in writing and are not covered by Section 7.4; or
(c) Any breach by Veridian, a Participating Site, an Investigator, or Site Personnel of their respective obligations, representations, warranties, or covenants under this Agreement or Applicable Law.
Section 7.6 — Caps on Site Indemnification. The indemnification obligations of Veridian and the Participating Sites under Section 7.5 shall be subject to the following limitations:
(a) Per-Site Per-Occurrence Cap: Five Million Dollars ($5,000,000) per Participating Site per occurrence.
(b) Aggregate Network Cap: Twenty Million Dollars ($20,000,000) in the aggregate across all Participating Sites within the Veridian Network.
Section 7.7 — Notice and Defense Procedures. The following procedures shall apply to all claims for indemnification under this Article VII:
(a) Notice: The indemnified party shall provide written notice to the indemnifying party of any claim, demand, action, or suit for which indemnification is sought within thirty (30) calendar days of the date on which the indemnified party becomes aware of such claim, demand, action, or suit. Such notice shall describe the claim in reasonable detail and shall include copies of any relevant documents or correspondence. The failure of the indemnified party to provide timely notice shall not relieve the indemnifying party of its indemnification obligation, except to the extent that the indemnifying party is materially prejudiced by such failure.
(b) Assumption of Defense: The indemnifying party shall have the right, but not the obligation, to assume the defense of any claim for which indemnification is sought, using counsel of its choosing that is reasonably acceptable to the indemnified party. The indemnifying party shall notify the indemnified party of its election to assume the defense within thirty (30) calendar days of receipt of the notice described in subsection (a) above.
(c) Participation: If the indemnifying party assumes the defense of a claim, the indemnified party may participate in such defense at its own expense, using counsel of its own choosing. The indemnified party shall cooperate fully with the indemnifying party in connection with the defense of any claim.
(d) Settlement: The indemnifying party shall not settle, compromise, or consent to the entry of judgment with respect to any claim without the prior written consent of the indemnified party, which consent shall not be unreasonably withheld, conditioned, or delayed. Notwithstanding the foregoing, the indemnifying party may settle a claim without the consent of the indemnified party if: (i) the settlement involves only the payment of money by the indemnifying party; (ii) the settlement does not impose any injunctive or other non-monetary obligation on the indemnified party; and (iii) the settlement includes a complete and unconditional release of the indemnified party from all liability with respect to such claim.
Section 7.8 — Survival. The indemnification obligations set forth in this Article VII shall survive the termination or expiration of this Agreement, regardless of the reason for such termination or expiration, and shall continue in full force and effect until the expiration of the applicable statute of limitations for the claims to which such indemnification obligations relate.
ARTICLE VIII — INSURANCE
Section 8.1 — Sponsor Insurance. Penterra shall obtain and maintain clinical trial liability insurance coverage throughout the term of this Agreement and for a period of [2] years following the completion or termination of the Study at all Participating Sites, with the following minimum coverage limits:
(a) Per-occurrence limit: Twenty-Five Million Dollars ($25,000,000);
(b) Aggregate limit: Seventy-Five Million Dollars ($75,000,000);
(c) Subject-injury sublimit: Ten Million Dollars ($10,000,000) per occurrence and Fifty Million Dollars ($50,000,000) in the aggregate.
As of the date of this Agreement, Penterra's clinical trial liability insurance is provided under Policy No. BM-CTL-2023-04182, issued by Briarcliff Mutual Insurance Company, 55 Constitution Plaza, Hartford, Connecticut 06103. The current policy period is April 1, 2023 through March 31, 2024, and the policy is renewable annually. Penterra shall cause Veridian and each Participating Site to be named as additional insureds under the Briarcliff Policy or any successor policy, and shall provide evidence of such additional insured status in the certificate of insurance delivered pursuant to Section 8.3. Penterra shall maintain insurance coverage meeting the requirements of this Section 8.1 throughout the term of this Agreement and for a period of [2] years following the completion or termination of the Study (the "Tail Period").
Section 8.2 — Site Insurance. Veridian and each Participating Site shall obtain and maintain general liability and professional liability (medical malpractice) insurance coverage throughout their respective participation in the CLARION Trial, with the following minimum coverage limits:
(a) Per-occurrence limit: at least Five Million Dollars ($5,000,000); and
(b) Aggregate limit: at least Ten Million Dollars ($10,000,000).
Evidence of insurance coverage satisfying the requirements of this Section 8.2 shall be provided by Veridian and each Participating Site to Penterra within fifteen (15) business days of the execution of this Agreement (or, in the case of a Participating Site that executes an Individual Site Agreement after the Effective