PRINCIPAL INVESTIGATOR AGREEMENT
Between
PENTERRA PHARMACEUTICALS CORP.
and
DR. CATHERINE ALDRIDGE, M.D., Ph.D.
Protocol PPC-4871-III (CLARION)
Effective Date: June 28, 2023
PRINCIPAL INVESTIGATOR AGREEMENT
This Principal Investigator Agreement (this "Agreement") is entered into as of June 28, 2023 (the "Effective Date"), by and between:
PENTERRA PHARMACEUTICALS CORP. ("Sponsor" or "Penterra"), a corporation organized and existing under the laws of the State of Delaware, with its principal offices located at 200 Biopharma Boulevard, Suite 1400, Princeton, New Jersey 08540, publicly traded on the Nasdaq Stock Market under the ticker symbol PTRA;
and
DR. CATHERINE ALDRIDGE, M.D., Ph.D. ("Investigator" or "Global PI"), an individual residing in the Commonwealth of Pennsylvania, currently serving as Professor of Oncology at Graystone University Medical Center, located at 1200 University Avenue, Philadelphia, Pennsylvania 19104.
The Sponsor and the Investigator are each referred to herein as a "Party" and collectively as the "Parties."
Dr. Aldridge is affiliated with Veridian Health Research Network, Inc. ("Veridian" or "VHRN"), a Delaware 501(c)(3) nonprofit corporation headquartered at 750 Research Parkway, 8th Floor, Philadelphia, Pennsylvania 19104, which serves as the coordinating network organization for multi-site clinical research conducted across its member institutions.
This Agreement is entered into in connection with and supplemental to the Master Clinical Trial Agreement ("MCTA") dated June 28, 2023, between Penterra Pharmaceuticals Corp. and Veridian Health Research Network, Inc., and the Individual Site Agreement for Graystone University Medical Center (Site 001) of even date herewith. Graystone University Medical Center is a Pennsylvania nonprofit corporation and a Veridian Network member institution.
RECITALS
WHEREAS, Penterra is the sponsor of a Phase III, randomized, double-blind, placebo-controlled clinical trial of penterafenib (PPC-4871), an oral multi-kinase inhibitor, in subjects with advanced hepatocellular carcinoma ("HCC") who have received prior systemic therapy, conducted under Protocol PPC-4871-III, known as CLARION — Clinical Assessment of Response with Longitudinal Investigation in ONcology (the "Study");
WHEREAS, Penterra holds Investigational New Drug Application No. 157823 ("IND 157823") for penterafenib, filed with the United States Food and Drug Administration ("FDA") in October 2021, and the Phase II clinical program for penterafenib was completed in January 2023, demonstrating a thirty-eight percent (38%) objective response rate ("ORR") in subjects with advanced HCC, supporting advancement to the Phase III pivotal trial;
WHEREAS, the CLARION trial has been registered under ClinicalTrials.gov Identifier NCT05928174;
WHEREAS, the CLARION trial plans to enroll approximately 1,200 subjects, randomized in a 2:1 ratio of penterafenib to placebo (i.e., approximately 800 subjects in the treatment arm and approximately 400 subjects in the placebo arm), across thirty-eight (38) Veridian Network sites located in fourteen (14) states within the United States, over a projected forty-two (42) month enrollment period, with an estimated total study duration of sixty (60) months from first patient in to final database lock;
WHEREAS, the primary endpoint of the CLARION trial is overall survival ("OS"), with key secondary endpoints including progression-free survival ("PFS"), objective response rate ("ORR"), and duration of response ("DOR");
WHEREAS, Penterra desires to appoint Dr. Catherine Aldridge as the Global Principal Investigator for Protocol PPC-4871-III (CLARION), and Dr. Aldridge is willing to accept such appointment, subject to the terms and conditions set forth herein;
WHEREAS, Dr. Aldridge is board-certified in Medical Oncology and Hematology by the American Board of Internal Medicine, possesses extensive clinical research experience in hepatocellular carcinoma and other solid tumors, and has the qualifications, training, and experience necessary to serve as Global Principal Investigator for the CLARION trial;
WHEREAS, Penterra has engaged Meridian Contract Research Organization, Inc. ("Meridian CRO"), a Delaware corporation headquartered at 9200 Corporate Boulevard, Raleigh, North Carolina 27615, under a Master Services Agreement dated January 15, 2023, for monitoring, data management, safety reporting, pharmacovigilance, and biostatistics services in connection with the CLARION trial;
WHEREAS, Pinnacle Data Solutions, Inc. provides the electronic data capture ("EDC") platform for the CLARION trial, and Northbridge Bioanalytical Laboratories, Inc. provides central laboratory services for the trial; and
WHEREAS, the Parties desire to set forth their respective rights and obligations in connection with the appointment of Dr. Aldridge as Global Principal Investigator, including her specific duties, compensation, and compliance obligations.
NOW, THEREFORE, in consideration of the mutual promises, covenants, and agreements contained herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:
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ARTICLE 1 — DEFINITIONS
Capitalized terms used in this Agreement and not otherwise defined herein shall have the meanings ascribed to them in the MCTA. The following terms shall have the meanings set forth below:
1.1 "Agreement" means this Principal Investigator Agreement, including all appendices and exhibits attached hereto and incorporated herein by reference, as may be amended from time to time in accordance with Section 15.2.
1.2 "Applicable Law" means all federal, state, and local laws, rules, regulations, ordinances, orders, and guidance documents applicable to the conduct of the Study, including without limitation: (a) Title 21 of the United States Code of Federal Regulations ("C.F.R."), Parts 11 (Electronic Records; Electronic Signatures), 50 (Protection of Human Subjects), 54 (Financial Disclosure by Clinical Investigators), 56 (Institutional Review Boards), and 312 (Investigational New Drug Application); (b) the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ("ICH") Guideline E6(R2) on Good Clinical Practice; (c) the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations at 45 C.F.R. Parts 160 and 164 ("HIPAA"); (d) the Federal Anti-Kickback Statute, 42 U.S.C. § 1320a-7b, and the safe harbor regulations promulgated thereunder; (e) the Physician Payments Sunshine Act (Section 6002 of the Affordable Care Act, codified at 42 U.S.C. § 1320a-7h) and its implementing regulations; and (f) all other applicable federal, state, and local statutes and regulations governing the conduct of clinical investigations, human subjects research, and investigational products.
1.3 "Confidential Information" has the meaning ascribed to such term in Exhibit F to the MCTA (Confidentiality Provisions), and includes without limitation all Protocol-related information, investigational product specifications, formulations, manufacturing processes, pre-clinical and clinical data, study data, statistical analyses, regulatory submissions, business plans, financial terms of this Agreement, and all other proprietary or trade secret information disclosed by Penterra to Dr. Aldridge in connection with the Study. The confidentiality obligations with respect to Confidential Information shall remain in effect for a period of ten (10) years from the date of each disclosure.
1.4 "CRO" means Meridian Contract Research Organization, Inc., a Delaware corporation headquartered at 9200 Corporate Boulevard, Raleigh, North Carolina 27615, engaged by Penterra as the contract research organization for the CLARION trial.
1.5 "FDA" means the United States Food and Drug Administration and any successor agency thereof.
1.6 "GCP" means Good Clinical Practice as set forth in the ICH Guideline E6(R2), including all applicable annexes, addenda, and subsequent revisions adopted during the Term of this Agreement.
1.7 "IND" means Investigational New Drug Application No. 157823, held by Penterra with respect to penterafenib (PPC-4871) and filed with the FDA.
1.8 "Institution" means Graystone University Medical Center, a Pennsylvania nonprofit corporation located at 1200 University Avenue, Philadelphia, Pennsylvania 19104.
1.9 "Investigational Product" or "IP" means penterafenib (PPC-4871), an oral multi-kinase inhibitor being investigated under Protocol PPC-4871-III (CLARION), including all dosage forms, formulations, and matching placebo supplied by Penterra for use in the Study.
1.10 "IRB" means the Graystone University Institutional Review Board, IRB Registration Number IRB00012847, or such other institutional review board or ethics committee as may have jurisdiction over Study activities at a particular Site, including the Veridian Central IRB where applicable.
1.11 "MCTA" means the Master Clinical Trial Agreement dated June 28, 2023, between Penterra Pharmaceuticals Corp. and Veridian Health Research Network, Inc., including all exhibits, schedules, and amendments thereto.
1.12 "Protocol" means Protocol PPC-4871-III (CLARION), as may be amended from time to time in accordance with the procedures set forth in the MCTA and applicable regulatory requirements.
1.13 "SAE" means a Serious Adverse Event, as defined in 21 C.F.R. § 312.32 and the ICH Guideline E6(R2), 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 or require medical or surgical intervention to prevent one of the outcomes listed above.
1.14 "Site" means, with respect to Dr. Aldridge's obligations as site Principal Investigator, Graystone University Medical Center (designated as Site 001), and, with respect to Dr. Aldridge's Global PI oversight responsibilities, all thirty-eight (38) participating Veridian Network sites conducting the Study under the MCTA.
1.15 "Study" means the Phase III clinical trial of penterafenib conducted under Protocol PPC-4871-III (CLARION), ClinicalTrials.gov Identifier NCT05928174, including all activities related to subject enrollment, treatment administration, follow-up assessments, data collection, and safety reporting across all participating Sites.
1.16 "Study Data" means all data, records, case report forms, electronic data capture entries, source documents, biological specimens, images, laboratory results, and any other information generated, collected, or compiled in connection with the Study at any participating Site.
1.17 "Veridian" means Veridian Health Research Network, Inc., a Delaware 501(c)(3) nonprofit corporation headquartered at 750 Research Parkway, 8th Floor, Philadelphia, Pennsylvania 19104.
ARTICLE 2 — APPOINTMENT AND TERM
2.1 Appointment. Penterra hereby appoints Dr. Catherine Aldridge, M.D., Ph.D. as the Global Principal Investigator for Protocol PPC-4871-III (CLARION). Dr. Aldridge hereby accepts such appointment and agrees to perform the duties and responsibilities set forth in this Agreement, the MCTA, and the Protocol with due diligence, professional competence, and in compliance with all Applicable Law. In her capacity as Global PI, Dr. Aldridge shall serve as the lead clinical investigator for the CLARION trial across all participating Veridian Network sites and shall bear overall scientific and medical responsibility for the integrity and quality of the Study as a whole.
2.2 Term. This Agreement shall be effective as of June 28, 2023 (the "Effective Date"), and shall continue in full force and effect until the earliest of: (a) completion of the Study, including final database lock, regulatory submissions, and the satisfaction of all record-retention and reporting obligations, currently projected for August 2028; (b) termination of the MCTA in accordance with its terms, subject to the one-hundred-twenty (120) day wind-down period set forth therein; (c) termination of this Agreement pursuant to Article 11 hereof; or (d) the date upon which the Parties mutually agree in writing to terminate this Agreement (the "Term"). For the avoidance of doubt, the survival provisions set forth in Section 11.5 shall remain in effect notwithstanding the expiration or termination of this Agreement.
2.3 Relationship to MCTA. This Agreement is supplemental to and shall be read in conjunction with the MCTA, the Individual Site Agreement for Site 001, and the IP Side Letter dated June 28, 2023. In the event of any conflict or inconsistency between the terms and conditions of this Agreement and those of the MCTA, the terms and conditions of the MCTA shall govern and control, except with respect to Investigator-specific obligations, duties, representations, and warranties expressly set forth herein, which shall supplement and be in addition to the obligations set forth in the MCTA. Where this Agreement imposes more specific or more stringent requirements on Dr. Aldridge than those imposed by the MCTA, the more specific or more stringent requirements of this Agreement shall apply to Dr. Aldridge in her individual capacity.
ARTICLE 3 — GLOBAL PRINCIPAL INVESTIGATOR RESPONSIBILITIES
3.1 Overall Oversight. Dr. Aldridge shall serve as the Global Principal Investigator for the CLARION trial and shall provide overall scientific and medical oversight of the Study across all thirty-eight (38) Veridian Network sites located in fourteen (14) states. In this capacity, Dr. Aldridge shall: (a) serve as the primary scientific point of contact between the Sponsor and the Veridian Network for matters relating to the Protocol, study conduct, and clinical interpretation of Study Data; (b) chair the Study Steering Committee and provide clinical leadership at investigator meetings; (c) coordinate with the Co-Principal Investigator, Dr. Howard Matsuoka, M.D. (Associate Professor of Hepatology & Oncology, Lakemont Medical Center, 4400 North Michigan Drive, Chicago, Illinois 60611), on trial conduct at Lakemont Medical Center (Site 002) and at other designated sites within the Veridian Network; (d) provide medical and scientific guidance to site Principal Investigators on matters of Protocol interpretation, patient eligibility, and clinical management of study subjects; and (e) participate in periodic study-wide teleconferences, site visits, and investigator training sessions as reasonably requested by Penterra or Meridian CRO.
3.2 Protocol Compliance. Dr. Aldridge shall ensure that the Study is conducted in strict accordance with the Protocol, Good Clinical Practice as set forth in ICH E6(R2), and all Applicable Law, including without limitation 21 C.F.R. Parts 50 (Protection of Human Subjects), 56 (Institutional Review Boards), and 312 (Investigational New Drug Application). Dr. Aldridge shall not implement any deviation from, or changes to, the Protocol without prior written approval from Penterra and the applicable IRB, except where necessary to eliminate an immediate hazard to study subjects, in which case she shall promptly notify Penterra and the IRB of the deviation and the reasons therefor. Dr. Aldridge shall promptly report to Penterra any Protocol deviations, violations, or non-compliance events at Site 001, and shall use commercially reasonable efforts to identify and escalate systemic compliance issues across the Veridian Network.
3.3 FDA Form 1572. Dr. Aldridge shall complete, sign, and submit to Penterra the FDA Form 1572 (Statement of Investigator) prior to the activation of Site 001 for enrollment. Dr. Aldridge shall maintain the accuracy and completeness of the information contained in her FDA Form 1572 throughout the Term of the Study and shall promptly update the form to reflect any changes in sub-investigators, research facilities, clinical laboratories, institutional review board affiliation, or other information required to be disclosed therein. Dr. Aldridge acknowledges that her signature on FDA Form 1572 constitutes a binding commitment to comply with the requirements of 21 C.F.R. Part 312, including the obligation to conduct the Study in accordance with the Protocol and the signed agreement, to protect the rights, safety, and welfare of study subjects, and to ensure that informed consent is obtained in accordance with Applicable Law.
3.4 Subject Enrollment and Informed Consent. Dr. Aldridge shall oversee subject enrollment activities at Graystone University Medical Center (Site 001) and shall provide guidance, training, and oversight to site Principal Investigators across the Veridian Network with respect to enrollment strategies, eligibility assessment, and informed consent procedures. Dr. Aldridge shall ensure that informed consent is obtained from each study subject (or, where applicable, the subject's legally authorized representative) prior to the subject's participation in any study-related procedures, in accordance with 21 C.F.R. Part 50 and the requirements of the applicable IRB. The informed consent process shall be conducted in a manner that allows sufficient time and opportunity for the subject to consider whether or not to participate, provides adequate disclosure of all material information regarding the Study, and documents the subject's voluntary agreement to participate. The target date for first patient in at Site 001 is August 14, 2023. Dr. Aldridge shall use reasonable efforts to achieve enrollment targets at Site 001 as set forth in the MCTA and shall collaborate with Penterra and Meridian CRO on network-wide enrollment strategies to achieve the overall enrollment goal of 1,200 subjects within the forty-two (42) month enrollment period.
3.5 IRB Interaction. Dr. Aldridge shall serve as the principal liaison with the Graystone University Institutional Review Board (IRB Registration Number: IRB00012847) for all Study-related matters at Site 001. In this capacity, Dr. Aldridge shall: (a) submit the Protocol, informed consent form, Investigator's Brochure, and all other required study documents to the IRB for initial review and approval prior to study initiation; (b) submit all Protocol amendments, revised informed consent documents, safety reports, and other required communications to the IRB in a timely manner; (c) maintain current IRB approval for the Study throughout the Term, including timely submission of continuing review applications; (d) promptly report to the IRB all unanticipated problems involving risks to subjects or others, Protocol deviations, and other events requiring IRB notification under Applicable Law and institutional policies; and (e) coordinate with Veridian's Central IRB coordination office as needed for network-wide IRB matters, including reliance agreements and coordinated review of multi-site Protocol amendments.
3.6 Investigational Product Accountability. Dr. Aldridge shall maintain accurate and complete accountability records for the Investigational Product (penterafenib / PPC-4871) and matching placebo at Site 001, in accordance with the Protocol, GCP, and Applicable Law. Such accountability records shall document the receipt, storage conditions (including temperature monitoring), dispensing to subjects, return of unused or partially used supplies, and destruction of expired or unused Investigational Product. Dr. Aldridge shall ensure that the Investigational Product is stored in a secure, access-controlled area at Site 001, maintained at the storage conditions specified in the Protocol and Investigational Product labeling, and administered only to enrolled study subjects in accordance with the Protocol. Dr. Aldridge shall reconcile all Investigational Product supplies at Site 001 and shall cooperate with Meridian CRO monitors in the verification of Investigational Product accountability records.
3.7 Sub-Investigator Supervision. Dr. Aldridge shall supervise and maintain oversight of all sub-investigators, research coordinators, and other study staff participating in the conduct of the Study at Site 001. Dr. Aldridge shall ensure that all sub-investigators and study staff are appropriately qualified, trained in the Protocol and GCP, and listed on the delegation of authority log maintained at Site 001. Dr. Aldridge shall delegate study tasks only to qualified individuals and shall retain responsibility for the overall conduct and quality of the Study at Site 001. In her capacity as Global PI, Dr. Aldridge shall provide guidance on training standards, competency assessments, and best practices to site Principal Investigators across the Veridian Network, and shall participate in the development and delivery of network-wide investigator and coordinator training programs.
3.8 Source Document Maintenance. Dr. Aldridge shall ensure that adequate, accurate, and contemporaneous source documents and case histories are maintained at Site 001 for each study subject, documenting all study visits, assessments, procedures, adverse events, concomitant medications, and Protocol deviations. Source documents shall be maintained in a manner that permits verification of case report form entries and electronic data capture records, and shall be available for inspection and review by the Sponsor, Meridian CRO clinical monitors, the FDA, the IRB, and other authorized regulatory authorities. Dr. Aldridge shall ensure that corrections to source documents are made in a manner consistent with GCP requirements, using single-line strikethroughs, the date of correction, and the initials of the individual making the correction.
3.9 Record Retention. Dr. Aldridge shall retain all essential documents, source records, case report forms, regulatory correspondence, IRB communications, informed consent forms, Investigational Product accountability records, and all other Study-related records at Site 001 for a minimum period of fifteen (15) years following completion of the Study, or for such longer period as may be required by Applicable Law, Penterra's record retention policies, or the terms of the MCTA. Dr. Aldridge shall not destroy, transfer, or otherwise dispose of any Study-related records without prior written approval from Penterra. In the event that Dr. Aldridge's affiliation with Graystone University Medical Center terminates during or after the Study, Dr. Aldridge shall ensure that custody of all Study-related records is transferred to a successor investigator or institutional custodian acceptable to Penterra, and shall promptly notify Penterra of such transfer.
3.10 Cooperation with CRO. Dr. Aldridge shall cooperate fully with Meridian CRO in its monitoring, data management, safety reporting, and biostatistical analysis activities related to the CLARION trial. Without limiting the generality of the foregoing, Dr. Aldridge shall: (a) facilitate timely and accurate data entry into the Pinnacle Data Solutions electronic data capture (EDC) platform, including resolution of data queries within the timelines specified in the MCTA; (b) make source documents and Study records available for review by Meridian CRO clinical monitors during scheduled and unscheduled monitoring visits; (c) participate in monitoring visit discussions, co-monitoring activities, and site assessment visits as reasonably requested; (d) coordinate specimen handling, processing, and shipping to Northbridge Bioanalytical Laboratories, Inc. (central laboratory) in accordance with the laboratory manual and specimen handling procedures; and (e) ensure that site staff at Site 001 are responsive to CRO inquiries and requests for information related to the Study.
ARTICLE 4 — SAFETY REPORTING OBLIGATIONS
4.1 SAE Reporting. Dr. Aldridge shall report all Serious Adverse Events (SAEs) occurring at Site 001 to Penterra and Meridian CRO within twenty-four (24) hours of becoming aware of the event, utilizing the safety reporting procedures, forms, and electronic reporting systems set forth in the MCTA (Exhibit J — Safety Reporting Procedures). SAE reports shall include all available information regarding the nature of the event, the subject's medical history and concomitant medications, the temporal relationship to the Investigational Product, and the Investigator's assessment of causality. Dr. Aldridge shall provide follow-up reports with additional information as it becomes available, including outcome, resolution, and any actions taken with respect to the Investigational Product. In her capacity as Global PI, Dr. Aldridge shall also review aggregate safety data across the Veridian Network and promptly communicate any trends or patterns that may represent emerging safety signals to Penterra's medical safety team.
4.2 IND Safety Reports. Dr. Aldridge shall cooperate with Penterra in the preparation and submission of IND safety reports to the FDA, as required under 21 C.F.R. § 312.32. Such cooperation shall include the timely provision of clinical information and assessments necessary for the preparation of: (a) seven (7) calendar day reports for fatal or life-threatening unexpected suspected adverse reactions (SUSARs); and (b) fifteen (15) calendar day reports for all other reportable events, including unexpected adverse reactions that are serious but not fatal or life-threatening. Dr. Aldridge shall review and provide clinical input on draft safety reports prepared by Penterra or Meridian CRO and shall respond to requests for additional information within the timelines necessary to meet regulatory submission deadlines.
4.3 Annual Reports. Dr. Aldridge shall assist Penterra in the preparation of IND annual reports as required under 21 C.F.R. § 312.33, by providing relevant safety summaries, enrollment updates, Protocol deviation summaries, and other information from Site 001 and, in her capacity as Global PI, from the Veridian Network as a whole. Dr. Aldridge shall review and provide comments on draft annual reports within such timelines as are reasonably requested by Penterra.
4.4 Safety Monitoring Coordination. Dr. Aldridge shall participate in interactions with the Data Safety Monitoring Board ("DSMB") as requested by Penterra, including the preparation of safety summaries, responses to DSMB inquiries, and attendance at DSMB meetings (whether in person or by teleconference). Dr. Aldridge shall promptly communicate any safety signals, unexpected patterns of adverse events, or other safety concerns to the Sponsor's Chief Medical Officer, Dr. Elaine Whitford, M.D., and Senior Vice President of Clinical Development, Dr. Marcus Yun, M.D., M.P.H. Such communications shall be made by the most expeditious means available, followed by a written summary within forty-eight (48) hours. Dr. Aldridge shall also participate in safety review committee meetings and ad hoc safety teleconferences as reasonably requested by Penterra throughout the Term of the Study.
ARTICLE 5 — REGULATORY OBLIGATIONS AND COMPLIANCE
5.1 GCP and Regulatory Compliance. Dr. Aldridge shall conduct the Study in full compliance with GCP as set forth in ICH E6(R2), the applicable provisions of Title 21 of the Code of Federal Regulations (including Parts 11, 50, 54, 56, and 312), and all other Applicable Law. Dr. Aldridge shall ensure that all study procedures, data collection activities, and safety reporting obligations are performed in accordance with these standards and shall implement corrective and preventive actions as necessary to address any deficiencies identified during monitoring visits, audits, or inspections. Dr. Aldridge shall complete all required GCP training and shall ensure that all sub-investigators and study staff at Site 001 have current GCP training certifications.
5.2 Regulatory Authority Inspections. Dr. Aldridge shall promptly notify Penterra, in writing, if the FDA or any other federal, state, or local regulatory authority initiates an inspection, audit, investigation, or inquiry related to the Study, Site 001, or Dr. Aldridge's conduct as an investigator. Such notification shall be provided within two (2) business days of Dr. Aldridge's receipt of notice of the inspection or inquiry. Dr. Aldridge shall cooperate fully with any such inspection and shall permit Penterra representatives to be present during the inspection to the extent permitted by law and institutional policy. Dr. Aldridge shall promptly provide Penterra with copies of any inspection observations (including FDA Form 483 observations), establishment inspection reports, warning letters, untitled letters, or other regulatory communications related to the Study, and shall cooperate with Penterra in the preparation and submission of responses to any such communications.
5.3 Debarment Representation. Dr. Aldridge represents and warrants that she has not been debarred, suspended, proposed for debarment, declared ineligible, or voluntarily excluded from participation in any federal health care program or FDA-regulated activity pursuant to the Generic Drug Enforcement Act of 1992 (21 U.S.C. § 335a), the Federal Acquisition Regulation, or any other applicable statute or regulation. Dr. Aldridge further represents that she has not been convicted of a criminal offense related to the provision of health care items or services and that she is not listed on the Office of Inspector General's List of Excluded Individuals and Entities ("LEIE") or the General Services Administration's System for Award Management ("SAM") exclusion list. Dr. Aldridge shall promptly notify Penterra, in writing, if any debarment, exclusion, or disqualification proceedings are initiated against her during the Term of this Agreement, or if she becomes aware of any circumstances that may give rise to such proceedings.
5.4 HIPAA Compliance. Dr. Aldridge shall comply with all applicable requirements of the Health Insurance Portability and Accountability Act of 1996, as amended, and its implementing regulations at 45 C.F.R. Parts 160 and 164 (collectively, "HIPAA"), with respect to the use and disclosure of protected health information ("PHI") of study subjects in connection with the Study. Dr. Aldridge shall ensure that appropriate research authorizations or, where applicable, waivers of authorization granted by the IRB in accordance with 45 C.F.R. § 164.512(i), are obtained prior to the use or disclosure of PHI for study purposes. Dr. Aldridge shall implement appropriate administrative, technical, and physical safeguards to protect the privacy and security of PHI in accordance with HIPAA and the policies and procedures of Graystone University Medical Center.
5.5 Anti-Kickback Statute Compliance. Dr. Aldridge acknowledges that the compensation payable under this Agreement and the MCTA has been negotiated at arm's length and reflects the fair market value of the legitimate services to be rendered by Dr. Aldridge in connection with the Study. The compensation is not intended to, and does not, constitute an inducement or reward for the referral of patients, the prescribing of the Investigational Product or any other pharmaceutical product, or the generation of any other business between the Parties. The arrangement contemplated by this Agreement is intended to satisfy the requirements of the personal services and management contracts safe harbor set forth in 42 C.F.R. § 1001.952(d), and the Parties shall use commercially reasonable efforts to ensure ongoing compliance with such safe harbor requirements throughout the Term.
ARTICLE 6 — FINANCIAL DISCLOSURE
6.1 Initial Disclosure. Prior to the commencement of any Study-related activities at Site 001 and prior to the activation of any participating Veridian Network site under Dr. Aldridge's oversight as Global PI, Dr. Aldridge shall complete and submit to Penterra a Financial Disclosure Certification in the form required under 21 C.F.R. Part 54, substantially in the form attached hereto as Appendix C. Such certification shall disclose or certify the absence of financial interests in Penterra or the Investigational Product that could affect the reliability and integrity of the Study Data, including: (a) equity interests (stock, stock options, or other ownership interests) in Penterra (Nasdaq: PTRA); (b) proprietary interests in penterafenib (PPC-4871), including patent rights, trademarks, or licensing arrangements; (c) significant payments of other sorts, as defined in 21 C.F.R. § 54.2(f); and (d) any other financial arrangement with Penterra, its affiliates, or its agents that could reasonably be perceived to create a conflict of interest.
6.2 Ongoing Disclosure. Dr. Aldridge shall promptly update her Financial Disclosure Certification during the course of the Study and for a period of one (1) year following the completion of the Study if there are any material changes in her financial interests, including but not limited to: (a) the acquisition, disposition, or material change in value of equity interests in Penterra (approximate market capitalization of approximately $4.2 billion as of Q1 2023); (b) the acquisition or disposition of proprietary interests in penterafenib (PPC-4871); (c) receipt of significant payments exceeding the thresholds set forth in 21 C.F.R. § 54.2(f) from Penterra or its affiliates; or (d) any other change that would require disclosure under 21 C.F.R. Part 54. Updated certifications shall be submitted to Penterra within thirty (30) calendar days of the change in circumstances giving rise to the disclosure obligation.
6.3 Cooperation. Dr. Aldridge shall cooperate with Penterra and its designated external auditor, Townsend Independent Auditors LLP, in any audits, reviews, or inquiries related to financial disclosure compliance under 21 C.F.R. Part 54. Such cooperation shall include the provision of relevant financial records, documentation of financial interests, and responses to inquiries from Penterra, Townsend Independent Auditors, or regulatory authorities. Dr. Aldridge acknowledges that the FDA may require Penterra to submit financial disclosure information as part of any marketing application for penterafenib and consents to such submission in accordance with Applicable Law.
ARTICLE 7 — COMPENSATION
7.1 Fair Market Value. All compensation payable to Dr. Aldridge under this Agreement has been determined by the Parties, after arm's-length negotiation and with reference to independent fair market value assessments, to reflect the fair market value of the services rendered by Dr. Aldridge in her capacities as site Principal Investigator at Site 001 and as Global Principal Investigator for the CLARION trial. The compensation is consistent with the requirements of the Federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b) and the personal services and management contracts safe harbor (42 C.F.R. § 1001.952(d)), and is not intended to take into account the volume or value of any referrals or other business generated between the Parties.
7.2 Per-Patient Fees. Dr. Aldridge's compensation for services rendered as site Principal Investigator at Site 001 (Graystone University Medical Center) shall be included within the per-patient site fees of Fifty-Two Thousand Dollars ($52,000) per evaluable subject as set forth in the MCTA (Exhibit B — Budget and Payment Schedule). Payment of per-patient fees shall be milestone-based, structured as follows:
(a) Twenty-five percent (25%) of the per-patient fee, equal to Thirteen Thousand Dollars ($13,000), payable upon randomization of the subject;
(b) Twenty-five percent (25%) of the per-patient fee, equal to Thirteen Thousand Dollars ($13,000), payable upon completion of the Week 12 assessment for the subject;
(c) Twenty-five percent (25%) of the per-patient fee, equal to Thirteen Thousand Dollars ($13,000), payable upon completion of the Week 24 assessment for the subject; and
(d) Twenty-five percent (25%) of the per-patient fee, equal to Thirteen Thousand Dollars ($13,000), payable upon study completion or the subject's final study visit, whichever occurs first.
Per-patient fees shall be allocated between the Institution and Dr. Aldridge in accordance with the budgetary provisions of the Individual Site Agreement for Site 001 and the internal policies of Graystone University Medical Center.
7.3 Global PI Stipend. In recognition of her additional responsibilities as Global Principal Investigator, including but not limited to oversight across all thirty-eight (38) Veridian Network sites, steering committee leadership, global safety oversight, regulatory liaison duties, and multi-center publication coordination, Penterra shall pay Dr. Aldridge a Global PI stipend from the Investigator Grants allocation of One Million Five Hundred Thousand Dollars ($1,500,000) set forth in the MCTA (Exhibit B — Budget and Payment Schedule, Section 4 — Investigator Grants). The specific amount, payment schedule, and activities covered by the Global PI stipend shall be as set forth in Appendix A to this Agreement, which is incorporated herein by reference. The Global PI stipend is separate from and in addition to the per-patient fees described in Section 7.2 and is payable regardless of the number of subjects enrolled at Site 001.
7.4 Payment Terms. All payments due to Dr. Aldridge under this Agreement shall be payable Net forty-five (45) days from Penterra's receipt of a proper invoice submitted by or through Veridian Health Research Network, Inc. and/or Graystone University Medical Center, in accordance with the invoicing and payment procedures set forth in the MCTA and the Individual Site Agreement for Site 001. Invoices shall be submitted in such form and with such supporting documentation as may be reasonably required by Penterra. All payments shall be routed through Veridian and/or Graystone University Medical Center in accordance with their internal policies and applicable institutional requirements, and Dr. Aldridge acknowledges that she shall not receive direct payment from Penterra except as may be specifically authorized by Veridian and Graystone University Medical Center.
7.5 No Additional Compensation. Except as expressly set forth in this Agreement and the MCTA, Dr. Aldridge shall not be entitled to any additional compensation, benefits, remuneration, honoraria, consulting fees, or other payments from Penterra in connection with the Study. Without limiting the foregoing, Dr. Aldridge shall not accept any gifts, payments, or transfers of value from Penterra that are not specifically contemplated by this Agreement, the MCTA, or the Individual Site Agreement for Site 001, without the prior written approval of Penterra's Office of Ethics and Compliance.
7.6 Open Payments / Sunshine Act Reporting. Dr. Aldridge acknowledges that payments and transfers of value made under this Agreement are subject to reporting by Penterra under the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h) and the Centers for Medicare & Medicaid Services Open Payments program. Dr. Aldridge agrees to cooperate with Penterra's reporting obligations under the Sunshine Act, including the timely review and verification of reported amounts, the provision of her National Provider Identifier (NPI) number and state medical license information, and the correction of any inaccuracies in reported data during the applicable review and dispute periods.
ARTICLE 8 — DATA OWNERSHIP AND STUDY RECORDS
8.1 Sponsor Data Ownership. Consistent with the terms and conditions of the MCTA, Penterra retains exclusive ownership of all Study Data generated in connection with Protocol PPC-4871-III (CLARION) across all participating Sites, including Site 001. Dr. Aldridge acknowledges and agrees that all clinical trial data, case report forms (whether paper or electronic), electronic data entered into the Pinnacle Data Solutions EDC system, laboratory results from Northbridge Bioanalytical Laboratories, radiographic images, biological specimens, pharmacokinetic and pharmacodynamic data, biomarker data, safety data, and all analyses, reports, summaries, and compilations derived from any of the foregoing (collectively, "Study Data") are and shall remain the sole and exclusive property of Penterra. Dr. Aldridge shall not use Study Data for any purpose other than the conduct of the Study and the exercise of her publication rights under Article 9, and shall not disclose Study Data to any third party except as expressly permitted under this Agreement, the MCTA, or Applicable Law. Nothing in this Section 8.1 shall be construed to limit Dr. Aldridge's right of access to Study Data generated at Site 001 for purposes of patient care.
8.2 Site Records. Dr. Aldridge shall maintain complete, accurate, and contemporaneous source documents and case histories at Site 001 for each subject enrolled in the Study. Such records shall include, without limitation, medical records, progress notes, laboratory reports, imaging studies, informed consent forms, eligibility checklists, Protocol deviation reports, adverse event reports, and Investigational Product accountability logs. All such records shall be maintained in a secure and organized manner, consistent with GCP requirements and the record-keeping policies of Graystone University Medical Center. Source documents and Study records shall be retained for a minimum period of fifteen (15) years following the completion of the Study, the date of the last regulatory approval based on the Study data, or as otherwise required by Applicable Law, whichever period is longest.
8.3 Access to Records. Dr. Aldridge shall provide Penterra, its authorized representatives, Meridian CRO clinical monitors, the FDA, the IRB, and other authorized regulatory authorities with direct access to source documents and all Study-related records maintained at Site 001. Such access shall be provided upon reasonable notice and during normal business hours, and shall include the right to inspect, copy, and audit all Study-related records. Dr. Aldridge shall ensure that appropriate HIPAA authorizations or waivers are in place to permit such access in compliance with applicable privacy regulations. Dr. Aldridge shall not refuse or unreasonably delay access to Study records requested by Penterra or regulatory authorities.
ARTICLE 9 — PUBLICATION RIGHTS
9.1 Academic Freedom. Penterra recognizes and respects the importance of academic freedom and the right of Dr. Aldridge, as an academic clinical investigator affiliated with Graystone University Medical Center, to publish the results of research conducted under the CLARION Protocol. The publication provisions set forth in this Article 9 are intended to balance the legitimate interests of Penterra in protecting Confidential Information and patentable inventions with the obligation to disseminate clinically significant findings to the scientific and medical community in a timely manner.
9.2 Sponsor Review Period. Prior to the submission of any manuscript, abstract, poster, oral presentation, or other publication or public disclosure based on Study Data (each, a "Proposed Publication"), Dr. Aldridge shall provide Penterra with a complete copy of the Proposed Publication for review. Penterra shall have sixty (60) calendar days from the date of its receipt of the Proposed Publication (the "Review Period") to review the document for the inclusion of Confidential Information and the potential disclosure of patentable subject matter. During the Review Period, Penterra may provide comments and suggestions regarding the Proposed Publication, which Dr. Aldridge shall consider in good faith but shall not be obligated to accept, except with respect to the removal of Confidential Information as set forth in Section 9.4.
9.3 Patent Filing Delay. If, during its review of the Proposed Publication, Penterra identifies patentable subject matter, Penterra may request in writing a delay in the submission or public presentation of the Proposed Publication for up to an additional ninety (90) calendar days beyond the initial sixty (60) day Review Period (the "Patent Delay Period"), for the sole purpose of permitting Penterra to prepare and file one or more patent applications covering the identified subject matter. The total delay period (Review Period plus Patent Delay Period) shall not exceed one hundred fifty (150) calendar days from the date of Penterra's receipt of the Proposed Publication. Dr. Aldridge agrees to comply with any such request for delay, provided that Penterra diligently pursues the filing of the applicable patent application(s) during the Patent Delay Period.
9.4 Removal of Confidential Information. Dr. Aldridge shall remove from the Proposed Publication any Confidential Information identified by Penterra during the Review Period prior to the submission or public presentation of the Proposed Publication. For the avoidance of doubt, aggregate clinical efficacy and safety data that are necessary for the scientific integrity of the publication shall not be considered Confidential Information for purposes of this Section 9.4, provided that such data do not disclose proprietary manufacturing processes, formulation details, or trade secrets of Penterra.
9.5 Multi-Center Publications. Dr. Aldridge agrees that the first publication of Study results shall be a multi-center publication reflecting the aggregate data from all participating Sites, consistent with ICH E6(R2) guidelines on the communication of clinical trial results and the publication provisions set forth in the MCTA (Exhibit G — Intellectual Property and Publication Rights). Individual site publications or subset analyses may be submitted following the publication or acceptance for publication of the primary multi-center manuscript, subject to the review procedures set forth in this Article 9. Dr. Aldridge shall serve as the lead author or co-lead author of the primary multi-center publication, as determined by the Publication Committee established under the MCTA.
9.6 Acknowledgment of Sponsorship. All publications arising from the Study shall include an appropriate acknowledgment of Penterra's sponsorship of the CLARION trial, and shall disclose Dr. Aldridge's role as Global Principal Investigator and any financial relationships between Dr. Aldridge and Penterra, in accordance with the International Committee of Medical Journal Editors (ICMJE) disclosure requirements and the policies of the relevant scientific journal or conference.
ARTICLE 10 — CONFIDENTIALITY
10.1 Obligations. Dr. Aldridge shall maintain in strict confidence all Confidential Information of Penterra disclosed to her or to which she has access in connection with the Study, including without limitation the Protocol and all amendments thereto, Investigational Product specifications, formulations, manufacturing processes, pre-clinical and clinical data, Study Data, statistical analyses, regulatory submissions, marketing plans, business strategies, financial terms of this Agreement and the MCTA, and all other information designated as confidential by Penterra or that, by its nature or the circumstances of its disclosure, would reasonably be understood to be confidential. Dr. Aldridge shall not use Confidential Information for any purpose other than the conduct of the Study and the performance of her obligations under this Agreement, and shall not disclose Confidential Information to any third party except as expressly permitted herein. Dr. Aldridge shall protect Confidential Information with at least the same degree of care that she uses to protect her own confidential information, but in no event less than a reasonable degree of care.
10.2 Term. The confidentiality obligations set forth in this Article 10 shall survive the expiration or termination of this Agreement and shall remain in full force and effect for a period of ten (10) years from the date of each disclosure of Confidential Information, or for such longer period as may be required by the MCTA or Applicable Law.
10.3 Permitted Disclosures. Notwithstanding the foregoing, Dr. Aldridge may disclose Confidential Information in the following circumstances, subject to the conditions specified:
(a) IRB Disclosure. To the Graystone University Institutional Review Board (IRB Registration Number: IRB00012847), or to the Veridian Central IRB, as necessary for the IRB's review, approval, and oversight of the Study, provided that the IRB maintains such information in confidence in accordance with its policies and Applicable Law;
(b) Regulatory Authority Disclosure. To the FDA or other federal, state, or local regulatory authorities, as required by Applicable Law or as necessary for the conduct of the Study, including in response to inspections, inquiries, or compulsory legal process;
(c) Legal Counsel. To Dr. Aldridge's personal legal counsel, on a need-to-know basis and under an obligation of confidentiality no less restrictive than the obligations set forth herein;
(d) Sub-Investigators and Study Staff. To sub-investigators, research coordinators, and other study staff at Site 001 and, in Dr. Aldridge's capacity as Global PI, to site Principal Investigators and their authorized personnel at other Veridian Network sites, on a need-to-know basis and only to the extent necessary for the conduct of the Study, provided that such individuals are bound by written confidentiality obligations at least as restrictive as those contained herein; and
(e) Compelled Disclosure. To the extent required by applicable law, regulation, court order, or governmental request, provided that Dr. Aldridge gives Penterra prompt written notice of such requirement (to the extent permitted by law) and cooperates with Penterra in seeking a protective order or other appropriate remedy to limit the scope of the required disclosure.
ARTICLE 11 — TERM AND TERMINATION
11.1 Term. The Term of this Agreement shall be as set forth in Section 2.2 of this Agreement.
11.2 Termination for Cause. Either Party may terminate this Agreement upon thirty (30) days' prior written notice to the other Party if the other Party commits a material breach of any provision of this Agreement that remains uncured at the expiration of such thirty (30) day notice period. The written notice shall describe the nature of the breach in reasonable detail and identify the specific provisions alleged to have been breached. Notwithstanding the foregoing, Penterra may terminate this Agreement immediately, without opportunity to cure, upon written notice to Dr. Aldridge if: (a) Dr. Aldridge is debarred, excluded, or disqualified from participation in any federal health care program or FDA-regulated activity; (b) Dr. Aldridge's medical license is suspended, revoked, or otherwise restricted by any state medical board or licensing authority; (c) Dr. Aldridge engages in scientific misconduct, fraud, or fabrication of Study Data; (d) Dr. Aldridge is indicted for or convicted of a felony or any crime involving moral turpitude; or (e) the continuation of the Study under Dr. Aldridge's oversight poses, in Penterra's reasonable judgment, an unacceptable risk to the safety of study subjects.
11.3 Termination Without Cause. Either Party may terminate this Agreement without cause upon ninety (90) days' prior written notice to the other Party, subject to the wind-down provisions of Section 11.4 and the corresponding provisions of the MCTA. In the event of termination without cause by either Party, Dr. Aldridge shall continue to perform her obligations under this Agreement during the notice period, except as otherwise directed by Penterra.
11.4 Effect of Termination / Wind-Down. Upon termination or expiration of this Agreement for any reason, Dr. Aldridge shall cooperate with Penterra in the orderly wind-down of the Study at Site 001 during the one-hundred-twenty (120) day wind-down period established under the MCTA. During the wind-down period, Dr. Aldridge shall: (a) ensure the safety and welfare of all study subjects currently enrolled at Site 001; (b) transition subjects in active treatment to another qualified investigator designated by Penterra or, where clinically appropriate and in the interest of subject safety, permit such subjects to complete their current treatment cycle under Dr. Aldridge's supervision; (c) complete all outstanding case report forms, data queries, and safety reports for subjects at Site 001; (d) reconcile all Investigational Product supplies and return unused Investigational Product to Penterra or its designated agent; (e) transfer all Study records and source documents to a successor investigator or institutional custodian designated by Penterra, in accordance with Section 3.9; (f) submit a final report to the IRB regarding the status of the Study at Site 001; and (g) cooperate in the transition of Global PI responsibilities to a successor designated by Penterra. Penterra shall compensate Dr. Aldridge for services rendered during the wind-down period in accordance with the compensation provisions of this Agreement and the MCTA.
11.5 Survival. The following provisions of this Agreement shall survive the expiration or termination of this Agreement for any reason: Article 6 (Financial Disclosure), Article 8 (Data Ownership and Study Records), Article 9 (Publication Rights, subject to the review periods set forth therein), Article 10 (Confidentiality, for the period set forth in Section 10.2), Article 12 (Indemnification), Article 13 (Representations and Warranties, to the extent applicable), Article 14 (Governing Law and Dispute Resolution), and any other provisions that by their nature are intended to survive termination.
ARTICLE 12 — INDEMNIFICATION
12.1 Sponsor Indemnification. As set forth in and subject to the terms and conditions of the MCTA (Exhibit D — Subject-Injury Indemnification Provisions), Penterra shall indemnify, defend, and hold harmless Dr. Aldridge and her agents, employees, and representatives (collectively, the "Investigator Indemnified Parties") 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 investigation and litigation) (collectively, "Losses") arising out of or relating to: (a) personal injury or death of a study subject caused by or attributable to the Investigational Product (penterafenib / PPC-4871) when administered in accordance with the Protocol; (b) any defect in the design, manufacture, labeling, packaging, storage, or distribution of the Investigational Product; (c) Penterra's material breach of the MCTA, this Agreement, or the Protocol; and (d) the negligence or willful misconduct of Penterra or its agents, employees, or representatives (including Meridian CRO, to the extent acting within the scope of its engagement by Penterra).
12.2 Carve-Outs. Penterra's indemnification obligations under Section 12.1 shall not extend to, and Penterra shall have no liability for, Losses arising from or attributable to: (i) the negligence, recklessness, or willful misconduct of Dr. Aldridge, her sub-investigators, or Site 001 personnel; (ii) deviation from the Protocol by Dr. Aldridge or Site 001 personnel that was not authorized by Penterra in writing and was not undertaken to eliminate an immediate hazard to study subjects; or (iii) breach of the MCTA, this Agreement, or Applicable Law by Dr. Aldridge, the Institution, or Site 001 personnel. In the event that Losses are attributable in part to circumstances covered by Penterra's indemnification obligation and in part to circumstances excluded therefrom, the Parties shall allocate responsibility for such Losses in proportion to their respective fault, as determined by agreement or, if the Parties are unable to agree, by the dispute resolution procedures set forth in Article 14.
12.3 Subject-Injury Medical Care. Penterra shall cover reasonable and customary medical costs for the treatment of study-related injuries sustained by subjects enrolled in the Study, to the extent such injuries are directly attributable to the Investigational Product or to protocol-required procedures, and are not covered by the subject's own health insurance, Medicare, Medicaid, or other third-party payor. Penterra's obligation to cover subject-injury medical costs shall be subject to: (a) a per-subject cap of Five Hundred Thousand Dollars ($500,000); and (b) an aggregate cap across all participating Sites of Fifteen Million Dollars ($15,000,000), as set forth in the MCTA (Exhibit D — Subject-Injury Indemnification Provisions). Notwithstanding the foregoing per-subject and aggregate caps, Penterra's indemnification obligation for Losses arising from product-defect claims (i.e., claims arising from defects in the design, manufacture, or labeling of the Investigational Product) shall be uncapped.
12.4 Notice Requirement. Dr. Aldridge shall provide written notice to Penterra within thirty (30) calendar days of becoming aware of any claim, demand, action, suit, or proceeding that may give rise to an indemnification obligation under this Article 12. Such notice shall include a description of the claim in reasonable detail, copies of any relevant correspondence, pleadings, or other documents, and an estimate of the potential Losses, to the extent then known. Dr. Aldridge shall cooperate with Penterra in the investigation and defense of any indemnified claim and shall not settle or compromise any such claim without Penterra's prior written consent. Failure by Dr. Aldridge to provide timely notice as required by this Section 12.4 shall not relieve Penterra of its indemnification obligations under this Article 12, except to the extent that Penterra demonstrates that it has been materially prejudiced by such delay.
12.5 Insurance. Penterra maintains clinical trial liability insurance through Briarcliff Mutual Insurance Company, under Policy Number BM-CTL-2023-04182, providing coverage for claims arising from the conduct of the CLARION trial. The policy provides the following coverage limits: (a) per-occurrence limit of Twenty-Five Million Dollars ($25,000,000); (b) aggregate limit of Seventy-Five Million Dollars ($75,000,000); and (c) a subject-injury sublimit of Ten Million Dollars ($10,000,000) per occurrence and Fifty Million Dollars ($50,000,000) in the aggregate. Dr. Aldridge is named as an additional insured under such policy with respect to claims arising from the conduct of the Study. The current policy period is April 1, 2023 through March 31, 2024, and is renewable on an annual basis. Penterra shall maintain clinical trial liability insurance with coverage limits no less than those set forth above throughout the Term of this Agreement and for a period of at least three (3) years following the completion or termination of the Study. Penterra shall provide Dr. Aldridge with a certificate of insurance evidencing such coverage upon request.
ARTICLE 13 — REPRESENTATIONS AND WARRANTIES
13.1 Investigator Representations. Dr. Aldridge hereby represents and warrants to Penterra as follows:
(a) Qualifications. She possesses the qualifications, training, clinical expertise, and professional experience, including board certification in Medical Oncology and Hematology by the American Board of Internal Medicine, necessary to assume and fulfill the responsibilities of Global Principal Investigator for the CLARION trial. She holds an active, unrestricted medical license in the Commonwealth of Pennsylvania and has appropriate clinical privileges at Graystone University Medical Center to conduct the Study.
(b) Protocol and Investigator's Brochure Review. She has received, reviewed, and is thoroughly familiar with the Protocol (PPC-4871-III / CLARION) and the Investigator's Brochure for penterafenib (PPC-4871), including all available pre-clinical an