1018-00004 · Penterra Pharmaceuticals Corp · Transaction Documents/Site Joinders

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INDIVIDUAL SITE AGREEMENT (JOINDER)

Site Number 004 — Cedar Falls University Hospital

Protocol PPC-4871-III (CLARION — Clinical Assessment of Response with Longitudinal Investigation in ONcology)

Investigational Product: Penterafenib (PPC-4871) ClinicalTrials.gov Identifier: NCT05928174 IND Number: IND 157823

This Individual Site Agreement (this "Agreement" or "ISA") is entered into as of June 28, 2023 (the "Execution Date"), as a joinder to the Master Clinical Trial Agreement dated June 28, 2023 (the "MCTA") between Penterra Pharmaceuticals Corp. ("Sponsor") and Veridian Health Research Network, Inc. ("Network"), and is entered into by and among the following parties:

PARTIES

PENTERRA PHARMACEUTICALS CORP. ("Sponsor"), 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;

VERIDIAN HEALTH RESEARCH NETWORK, INC. ("Network"), a corporation organized and existing under the laws of the State of Delaware and 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; and

CEDAR FALLS UNIVERSITY HOSPITAL ("Site" or "Institution"), a nonprofit corporation organized and existing under the laws of the State of Colorado, and a member institution of the Veridian Health Research Network, with its principal offices located at 1800 Cedar Falls Drive, Denver, Colorado 80204.

Each of the Sponsor, the Network, and the Site is sometimes referred to herein individually as a "Party" and collectively as the "Parties."

RECITALS

WHEREAS (Recital A), the Sponsor and the Network have entered into a Master Clinical Trial Agreement dated June 28, 2023 (the "MCTA"), which governs the conduct of Protocol PPC-4871-III, titled "CLARION — Clinical Assessment of Response with Longitudinal Investigation in ONcology," a Phase III, randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of penterafenib (PPC-4871) in the treatment of advanced hepatocellular carcinoma (HCC) in patients who have progressed on or are intolerant to at least one prior line of systemic therapy, including but not limited to atezolizumab plus bevacizumab, sorafenib, or lenvatinib;

WHEREAS (Recital B), Cedar Falls University Hospital is a member institution of the Veridian Health Research Network and has agreed to participate as an individual clinical trial site, designated as Site 004, under the terms and conditions of the MCTA, and the Site will screen, enroll, randomize, and treat subjects in accordance with Protocol PPC-4871-III and all applicable regulatory requirements;

WHEREAS (Recital C), this Individual Site Agreement constitutes a joinder to the MCTA pursuant to Exhibit C thereof (Form of Individual Site Agreement/Joinder), and by execution hereof, the Site agrees to be bound by all terms and conditions of the MCTA as if the Site were an original signatory thereto, with the MCTA incorporated herein by reference as if fully set forth in this Agreement;

WHEREAS (Recital D), the Site will rely on the Veridian Central Institutional Review Board (the "Veridian Central IRB") for institutional review board oversight of Protocol PPC-4871-III at this Site, pursuant to an IRB Authorization Agreement to be executed between Cedar Falls University Hospital and the Veridian Central IRB in accordance with 45 C.F.R. § 46.114 and applicable FDA regulations, and the Site acknowledges that no subjects may be enrolled at the Site until such IRB Authorization Agreement is fully executed and all required IRB approvals have been obtained; and

WHEREAS (Recital E), penterafenib (PPC-4871) is an orally administered multi-kinase inhibitor targeting FGFR1-4, VEGFR1-3, and PDGFR-α/β, for which the Sponsor filed an Investigational New Drug Application with the United States Food and Drug Administration ("FDA") in October 2021 (IND 157823), and for which a Phase II clinical trial was completed in January 2023, demonstrating an objective response rate (ORR) of thirty-eight percent (38%) per RECIST v1.1 in patients with advanced HCC, with a manageable safety profile, and the Sponsor, as the IND holder, is responsible for all IND-related regulatory obligations with respect to penterafenib;

NOW, THEREFORE, in consideration of the mutual covenants 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 1 — DEFINITIONS AND INTERPRETATION

Section 1.1 — Definitions. All capitalized terms used but not otherwise defined in this Individual Site Agreement shall have the meanings ascribed to such terms in the MCTA. For purposes of clarity and convenience, the following defined terms are reiterated or supplemented herein:

(a) "Central Laboratory" means Northbridge Bioanalytical Laboratories, Inc., the Sponsor's designated central laboratory for the CLARION trial, responsible for pharmacokinetic/pharmacodynamic (PK/PD) analyses, biomarker assessments, and safety laboratory analyses.

(b) "CRO" means Meridian Contract Research Organization, Inc., the Sponsor's contracted full-service contract research organization for the CLARION trial, providing clinical monitoring, data management, pharmacovigilance and safety reporting, biostatistical analysis, and regulatory support services.

(c) "EDC Platform" means the electronic data capture system provided by Pinnacle Data Solutions, Inc., as designated by the Sponsor for the collection, management, and transmission of clinical trial data under Protocol PPC-4871-III.

(d) "Investigational Product" or "IP" means penterafenib (PPC-4871), including all formulations, dosage forms, and packaging thereof supplied by the Sponsor for use in Protocol PPC-4871-III.

(e) "MCTA" means the Master Clinical Trial Agreement dated June 28, 2023, by and between the Sponsor and the Network, as the same may be amended, supplemented, or modified from time to time in accordance with its terms.

(f) "Network" means Veridian Health Research Network, Inc., a Delaware corporation and 501(c)(3) tax-exempt research organization.

(g) "Protocol" means Protocol PPC-4871-III (CLARION — Clinical Assessment of Response with Longitudinal Investigation in ONcology), including all amendments and administrative letters thereto approved by the Sponsor and the relevant IRB.

(h) "Site Principal Investigator" or "PI" means the physician designated in Schedule A to this Agreement as the principal investigator responsible for the conduct of Protocol PPC-4871-III at the Site.

(i) "Study" means the Phase III, randomized, double-blind, placebo-controlled clinical trial of penterafenib conducted under Protocol PPC-4871-III and IND 157823.

(j) "Veridian Central IRB" means the central institutional review board established and operated by the Veridian Health Research Network for the purpose of providing centralized IRB oversight of clinical trials conducted across Veridian Network member institutions.

Section 1.2 — Interpretation. In this Agreement, unless the context otherwise requires: (a) the singular includes the plural and vice versa; (b) references to "Articles," "Sections," "Schedules," and "Exhibits" are to the articles, sections, schedules, and exhibits of or to this Agreement unless otherwise specified; (c) the words "include," "includes," and "including" shall be deemed to be followed by the phrase "without limitation"; (d) references to any law, statute, or regulation shall be construed as including all statutory and regulatory provisions consolidating, amending, replacing, supplementing, or interpreting such law, statute, or regulation; and (e) headings and captions are for convenience of reference only and shall not affect the interpretation of this Agreement.

Section 1.3 — Order of Precedence. In the event of any conflict or inconsistency among the documents comprising the agreement between the Parties, the following order of precedence shall apply, from highest to lowest priority: (a) this Individual Site Agreement (with respect to Site-specific matters only); (b) the MCTA; (c) the Protocol; and (d) the Exhibits and Schedules to the MCTA and this Agreement. For the avoidance of doubt, in all matters that are not Site-specific, the terms of the MCTA shall govern and control.

ARTICLE 2 — INCORPORATION OF MCTA TERMS

Section 2.1 — Full Incorporation. All terms, conditions, obligations, rights, representations, warranties, covenants, and remedies set forth in the MCTA are hereby incorporated into this Individual Site Agreement by reference in their entirety and shall be binding on the Site, the Site Principal Investigator, and all site personnel as though the Site were an original signatory party to the MCTA. By executing this Agreement, the Site acknowledges that it has received, reviewed, and agreed to be bound by all provisions of the MCTA. The Network shall make available to the Site a complete copy of the fully executed MCTA, together with all Exhibits and Schedules thereto, within five (5) business days of the Execution Date of this Agreement. In the event of any conflict between the terms of this Individual Site Agreement and the terms of the MCTA, the terms of this Individual Site Agreement shall control solely with respect to Site-specific matters, including but not limited to Site-specific enrollment allocations, Site-specific budget and payment terms, Site-specific regulatory information, and the designation of the Site Principal Investigator. In all other respects, the terms of the MCTA shall govern and control.

Section 2.2 — MCTA Exhibits and Schedules Applicable to Site. The following Exhibits and Schedules to the MCTA are hereby incorporated into this Individual Site Agreement by reference and are applicable to the Site:

(a) Exhibit A — Protocol Synopsis (Protocol PPC-4871-III, CLARION);

(b) Exhibit B — Budget and Payment Schedule, as supplemented and further specified by Schedule B to this Agreement with respect to Site-specific financial terms;

(c) Exhibit D — Subject-Injury Indemnification Provisions, including detailed procedures for the identification, reporting, and management of study-related injuries and the allocation of financial responsibility therefor;

(d) Exhibit E — Insurance Requirements and Certificate Forms, specifying the minimum insurance coverage requirements for the Sponsor, the Network, and each participating Site;

(e) Exhibit F — Confidentiality and Data Protection Provisions, setting forth the obligations of all parties with respect to the protection of confidential information, trade secrets, and proprietary data;

(f) Exhibit G — Intellectual Property and Publication Rights, governing the ownership of inventions, data, and intellectual property arising from the Study and the rights of investigators and the Sponsor with respect to the publication of Study results;

(g) Exhibit H — Regulatory Compliance Representations and Covenants, including representations regarding compliance with FDA regulations, ICH GCP Guidelines, the Anti-Kickback Statute, and other applicable laws;

(h) Exhibit I — Form of Investigator Undertaking, to be executed by the Site Principal Investigator prior to enrollment of any subjects;

(i) Exhibit J — Safety Reporting Procedures, detailing the procedures and timelines for the reporting of adverse events, serious adverse events, and other safety information; and

(j) Exhibit K — Approved Subcontractors List, identifying all third-party service providers authorized to perform services in connection with the CLARION trial.

ARTICLE 3 — SCOPE OF WORK AND SITE OBLIGATIONS

Section 3.1 — Conduct of the Study. The Site shall conduct Protocol PPC-4871-III (CLARION) in strict accordance with the Protocol and all amendments thereto, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guideline for Good Clinical Practice, ICH E6(R2) (the "ICH GCP Guidelines"), all applicable regulations of the United States Food and Drug Administration (the "FDA"), including without limitation 21 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), and all applicable federal, state, and local laws, rules, and regulations. The Site shall ensure that the conduct of the Study at the Site meets the highest standards of scientific rigor, ethical practice, and regulatory compliance.

The Study is designed as a Phase III, randomized, double-blind, placebo-controlled, multi-center clinical trial. The planned total enrollment across all thirty-eight (38) participating Veridian Health Research Network sites is one thousand two hundred (1,200) subjects, randomized in a 2:1 ratio (penterafenib to placebo), resulting in an allocation of approximately eight hundred (800) subjects to the penterafenib treatment arm and approximately four hundred (400) subjects to the placebo control arm. The primary endpoint of the Study is overall survival (OS); secondary endpoints include progression-free survival (PFS), objective response rate (ORR) per RECIST v1.1, duration of response (DOR), and safety and tolerability assessments. The Site's individual enrollment allocation is as set forth in Schedule B to this Agreement. The Site shall use commercially reasonable efforts to achieve its allocated enrollment targets within the projected enrollment period described in Section 3.6 of this Article.

Section 3.2 — Site Principal Investigator. The Site Principal Investigator designated in Schedule A to this Agreement shall be responsible for the overall medical conduct of the trial at the Site, including but not limited to: (a) obtaining and documenting informed consent from each prospective subject in accordance with 21 C.F.R. Part 50 and the requirements of the Veridian Central IRB; (b) ensuring the safety, welfare, and rights of all subjects enrolled at the Site; (c) ensuring compliance with all Protocol requirements, including subject eligibility assessments, treatment administration, efficacy and safety evaluations, and follow-up procedures; (d) timely reporting of adverse events, serious adverse events, and other safety information in accordance with Article 9 of this Agreement and Exhibit J to the MCTA; (e) maintaining complete, accurate, and contemporaneous source documentation and case report forms; (f) overseeing the proper handling, storage, dispensing, accountability, and return or destruction of the Investigational Product at the Site; and (g) supervising all sub-investigators and site staff in the performance of their delegated trial-related duties.

Prior to the enrollment of any subjects at the Site, the Site Principal Investigator shall: (i) execute the Form of Investigator Undertaking attached as Exhibit I to the MCTA; (ii) execute and submit an FDA Form 1572 (Statement of Investigator) to the Sponsor; and (iii) complete and submit a Financial Disclosure Certification in accordance with the requirements of 21 C.F.R. Part 54, disclosing any financial interests, arrangements, or other relationships that could affect the objectivity of the investigator in the conduct of the Study. The Site Principal Investigator shall promptly notify the Sponsor in writing of any material change in his or her financial interests or arrangements during the course of the Study and for one (1) year following the completion of the Study.

Section 3.3 — Sub-Investigators and Site Personnel. All sub-investigators and study coordinators involved in the conduct of Protocol PPC-4871-III at the Site must be identified on the FDA Form 1572 filed by the Site Principal Investigator and must be qualified by education, training, and experience to perform their respective delegated trial-related duties. The Site shall maintain a current and accurate delegation of authority log (the "Delegation Log") for each sub-investigator and research staff member, documenting the specific tasks delegated to each individual by the Site Principal Investigator. The Delegation Log shall be updated promptly upon any change in personnel or delegation of duties and shall be made available to the Sponsor, the CRO, and the Veridian Central IRB upon request. All sub-investigators shall complete and submit Financial Disclosure Certifications under 21 C.F.R. Part 54 in the same manner as the Site Principal Investigator. The Site shall ensure that all site personnel involved in the conduct of the Study have received adequate training on the Protocol, ICH GCP Guidelines, applicable regulatory requirements, human subjects protection, and the proper use of the EDC Platform prior to performing any study-related duties.

Section 3.4 — IRB Oversight. The Site shall rely on the Veridian Central IRB as its IRB of record for Protocol PPC-4871-III. The Site acknowledges that the Veridian Central IRB will serve as the reviewing IRB responsible for the initial and continuing review of the Protocol, informed consent documents, recruitment materials, and all other study-related materials requiring IRB review and approval. An IRB Authorization Agreement between Cedar Falls University Hospital and the Veridian Central IRB, compliant with the requirements of 45 C.F.R. § 46.114 and the FDA's guidance on IRB reliance arrangements, must be fully executed and in place prior to the enrollment of any subjects at the Site. The Site shall cooperate with the Veridian Central IRB and shall promptly provide any information or documentation requested by the Veridian Central IRB in connection with its review of the Study.

The Site shall ensure that all required IRB approvals, including initial approval, continuing reviews (conducted at intervals not exceeding twelve (12) months), and approvals of Protocol amendments, informed consent revisions, and other study-related modifications, are obtained and maintained throughout the duration of the Study at the Site. The Site shall promptly report to the Veridian Central IRB all unanticipated problems involving risks to subjects or others, all serious adverse events that are both unexpected and related to the Investigational Product, and any instances of non-compliance with the Protocol or applicable regulations, in accordance with the reporting requirements established by the Veridian Central IRB and 21 C.F.R. Part 56. The Site shall also comply with any local institutional requirements for notification to a local IRB or institutional official, to the extent such requirements are not superseded by the IRB Authorization Agreement.

Section 3.5 — Approved Subcontractors. The Site acknowledges and agrees that the following approved subcontractors have been engaged by the Sponsor to provide services in connection with the CLARION trial, and the Site shall cooperate with such subcontractors in the performance of their respective duties:

(a) Meridian Contract Research Organization, Inc. (the "CRO"), which will provide clinical monitoring services (including on-site monitoring visits, remote monitoring, and source data verification), clinical data management, pharmacovigilance and safety reporting coordination, biostatistical analysis, and regulatory support services;

(b) Pinnacle Data Solutions, Inc., which will provide the EDC Platform used for the electronic capture, management, validation, and transmission of clinical trial data collected at the Site; and

(c) Northbridge Bioanalytical Laboratories, Inc. (the "Central Laboratory"), which will perform all centralized laboratory analyses, including pharmacokinetic and pharmacodynamic assessments, exploratory biomarker analyses (including circulating tumor DNA, alpha-fetoprotein kinetics, and FGFR pathway biomarkers), and safety laboratory evaluations (hematology, serum chemistry, coagulation, and urinalysis).

The Site shall facilitate the performance of monitoring visits by Meridian CRO clinical research associates, including providing adequate workspace, access to source documents and study records, and access to study subjects as reasonably requested. The Site shall ensure that all study data are entered into the EDC Platform in a timely, accurate, and complete manner and shall cooperate with Pinnacle Data Solutions in the resolution of data queries. The Site shall ensure that all laboratory specimens are collected, processed, labeled, stored, and shipped to the Central Laboratory in accordance with the laboratory manual provided by Northbridge Bioanalytical Laboratories.

Section 3.6 — Study Timeline. The projected timelines for the CLARION trial are as follows:

(a) Target First Patient In (FPI) across all sites: August 14, 2023;

(b) Projected enrollment period: Forty-two (42) months from FPI (projected Last Patient In: February 2027);

(c) Estimated total study duration: Sixty (60) months from FPI (projected study completion, including final database lock and study report: August 2028); and

(d) Site-specific activation target: The Site shall use commercially reasonable efforts to complete all Site activation requirements (including execution of this Agreement, IRB approval, site initiation visit, and resolution of any regulatory or operational pre-activation conditions) and to achieve its first patient enrolled within ninety (90) days of the Execution Date of this Agreement.

The Site shall use commercially reasonable efforts to achieve its allocated enrollment targets within the projected enrollment period. If the Site's enrollment falls materially below its allocated target, the Sponsor reserves the right, upon consultation with the Network, to reallocate enrollment among participating sites or to terminate this Agreement in accordance with Article 11, subject to the wind-down provisions therein.

ARTICLE 4 — FINANCIAL TERMS AND PAYMENT

Section 4.1 — Budget. The Site shall be compensated for the conduct of Protocol PPC-4871-III in accordance with the budget set forth in Schedule B to this Agreement, which is consistent with and supplements the budget framework established in Exhibit B to the MCTA. The total aggregate budget for the CLARION trial across all thirty-eight (38) participating Veridian Health Research Network sites is Eighty Million Dollars ($80,000,000.00). The Site's individual share of such aggregate budget shall be determined by the Site's allocated enrollment target and actual enrollment and is as set forth in detail in Schedule B. All payments to the Site shall be made through the Network in accordance with the invoicing and payment procedures set forth in this Article and in the MCTA.

Section 4.2 — Start-Up Fees. The Sponsor shall pay to the Site a one-time start-up fee of Seventy-Five Thousand Dollars ($75,000.00) to defray costs associated with Site activation, including regulatory submissions, staff training, equipment calibration, pharmacy set-up, and other Site readiness activities. The start-up fee shall be paid in two (2) equal installments as follows:

(a) Fifty percent (50%) of the start-up fee (Thirty-Seven Thousand Five Hundred Dollars ($37,500.00)) shall be payable upon Site activation, defined as the date on which the Site has satisfied all pre-activation requirements (including execution of this Agreement, IRB approval, completed site initiation visit, and confirmation by the CRO that the Site is ready to enroll); and

(b) Fifty percent (50%) of the start-up fee (Thirty-Seven Thousand Five Hundred Dollars ($37,500.00)) shall be payable upon the enrollment (randomization) of the first subject at the Site.

Section 4.3 — Per-Patient Site Fees. The Sponsor shall pay to the Site a per-patient fee of Fifty-Two Thousand Dollars ($52,000.00) for each subject who is screened and enrolled (randomized) at the Site, payable on a milestone-based payment schedule as follows:

(a) Randomization Milestone: Twenty-five percent (25%) of the per-patient fee (Thirteen Thousand Dollars ($13,000.00)) shall be payable upon the randomization of the subject;

(b) Week 12 Assessment Milestone: Twenty-five percent (25%) of the per-patient fee (Thirteen Thousand Dollars ($13,000.00)) shall be payable upon the completion of the Week 12 efficacy and safety assessment for the subject;

(c) Week 24 Assessment Milestone: Twenty-five percent (25%) of the per-patient fee (Thirteen Thousand Dollars ($13,000.00)) shall be payable upon the completion of the Week 24 efficacy and safety assessment for the subject; and

(d) Study Completion / Final Visit Milestone: Twenty-five percent (25%) of the per-patient fee (Thirteen Thousand Dollars ($13,000.00)) shall be payable upon the completion of the subject's final study visit or upon the subject's early termination from the Study, provided that all required end-of-treatment and follow-up procedures have been completed as specified in the Protocol.

For subjects who withdraw from the Study or are lost to follow-up prior to achieving a payment milestone, the Site shall be compensated on a prorated basis for services actually rendered, calculated in accordance with the procedures set forth in Schedule B.

Section 4.4 — Annual Site Maintenance Fees. The Sponsor shall pay to the Site an annual site maintenance fee of Forty Thousand Dollars ($40,000.00) per year to cover ongoing costs associated with the maintenance of the Site's participation in the Study, including but not limited to staff retention, equipment maintenance, regulatory compliance, record storage, and continuing education. The annual site maintenance fee shall be paid in advance on each anniversary of the date of Site activation. Based on the projected average duration of Site participation of approximately three and one-half (3.5) years, the estimated total site maintenance fees payable to the Site are One Hundred Forty Thousand Dollars ($140,000.00), subject to actual duration of participation.

Section 4.5 — Payment Terms. All payments under this Agreement shall be made within forty-five (45) calendar days from the Sponsor's receipt of a proper and complete invoice submitted by the Site through the Network. Invoices shall include: the Site number (004), the Protocol number (PPC-4871-III), the applicable milestone or fee description, the period of service, the amount invoiced, and supporting documentation as reasonably required by the Sponsor. Invoices shall be submitted to:

Samantha Novak Director, Clinical Contracts Penterra Pharmaceuticals Corp. 200 Biopharma Boulevard, Suite 1400 Princeton, New Jersey 08540

Email: s.novak@penterra.com

or to such other person or address as the Sponsor may designate in writing from time to time. All payments shall be made by wire transfer or electronic funds transfer (EFT) to the bank account designated by the Site in writing. The Site shall be responsible for all applicable taxes (excluding Sponsor's income taxes) on payments received hereunder.

Section 4.6 — Fair Market Value. The Site and the Site Principal Investigator represent and warrant that all compensation payable under this Agreement reflects fair market value for the services to be rendered and the time, effort, and expertise required, and that such compensation has been determined through arm's-length negotiations and does not take into account the volume or value of any referrals of patients, subjects, or services between the parties. The Site and the Site Principal Investigator further represent and warrant that the financial arrangements set forth herein do not constitute, and are not intended to constitute, any inducement, reward, or payment for the referral of subjects, patients, or services, and are consistent with the requirements of the Federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b) and all applicable safe harbor regulations promulgated thereunder. All payments to physicians and teaching hospitals shall be reported as required under Section 6002 of the Patient Protection and Affordable Care Act (the "Physician Payments Sunshine Act" or "Open Payments"), and the Site and the Site Principal Investigator shall cooperate with the Sponsor in ensuring the accuracy and completeness of all such reports.

ARTICLE 5 — INDEMNIFICATION

Section 5.1 — Sponsor Indemnification of Site and Investigators. Subject to the terms and conditions of this Article 5 and the provisions of Exhibit D to the MCTA, the Sponsor shall defend, indemnify, and hold harmless Cedar Falls University Hospital, its officers, directors, trustees, employees, agents, the Site Principal Investigator, all sub-investigators, and all site staff (collectively, the "Site Indemnified Parties") from and against any and all claims, demands, actions, suits, proceedings, losses, damages, liabilities, costs, and expenses (including reasonable attorneys' fees and costs of litigation) (collectively, "Losses") arising from or related to:

(a) Any injury, illness, death, or adverse event suffered by a Study subject that is caused by the Investigational Product (penterafenib, PPC-4871) when administered in accordance with the Protocol and the applicable informed consent;

(b) Any defect in the design, manufacture, formulation, labeling, packaging, storage, or shipment of the Investigational Product, including any failure to comply with current Good Manufacturing Practices (cGMP) or applicable FDA regulations;

(c) Any breach by the Sponsor of any representation, warranty, covenant, or obligation under the MCTA, this Individual Site Agreement, or the Protocol; and

(d) Any negligence, gross negligence, or willful misconduct of the Sponsor, its employees, agents, or representatives (including the CRO, to the extent acting within the scope of its engagement by the Sponsor) in connection with the Study.

Section 5.2 — Carve-Outs from Sponsor Indemnification. Notwithstanding the foregoing, the Sponsor's indemnification obligations under Section 5.1 shall not apply to the extent that Losses arise from or are attributable to:

(i) The negligence, gross negligence, or willful misconduct of the Site, the Site Principal Investigator, any sub-investigator, or any site personnel in the conduct of the Study;

(ii) Any deviation from the Protocol by the Site, the Site Principal Investigator, or site personnel that was not authorized in advance by the Sponsor in writing and was not reasonably necessary for the immediate protection of subject safety; or

(iii) Any breach by the Site, the Site Principal Investigator, or site personnel of any representation, warranty, covenant, or obligation under the MCTA, this Individual Site Agreement, or applicable law, including but not limited to failures to obtain proper informed consent, failures to comply with IRB requirements, and unauthorized use or disclosure of confidential information.

Section 5.3 — Subject Medical Care. In the event that a Study subject experiences a study-related injury (defined as an injury that is directly and proximately caused by the administration of the Investigational Product in accordance with the Protocol or by a study-required procedure), the Sponsor shall cover the reasonable and customary medical costs for the diagnosis and treatment of such injury to the extent that such costs are not covered by the subject's health insurance or other third-party coverage. The Sponsor's obligation under this Section 5.3 is subject to a per-subject cap of Five Hundred Thousand Dollars ($500,000.00) and an aggregate cap across all participating Veridian Network sites of Fifteen Million Dollars ($15,000,000.00). Claims arising from a defect in the Investigational Product (as described in Section 5.1(b)) are separately covered under the Sponsor's general indemnification obligation and are not subject to the per-subject or aggregate caps set forth in this Section 5.3. The procedures for reporting, documenting, and adjudicating claims for study-related injury medical costs are set forth in Exhibit D to the MCTA.

Section 5.4 — Site Indemnification of Sponsor. Subject to the terms and conditions of this Article 5 and the provisions of Exhibit D to the MCTA, Cedar Falls University Hospital shall defend, indemnify, and hold harmless the Sponsor, its officers, directors, employees, agents, and affiliates (collectively, the "Sponsor Indemnified Parties") from and against any and all Losses arising from or related to:

(a) The negligence, gross negligence, or willful misconduct of the Site, the Site Principal Investigator, any sub-investigator, or any site personnel in the conduct of the Study;

(b) Any deviation from the Protocol by the Site, the Site Principal Investigator, or site personnel that was not authorized in advance by the Sponsor in writing and was not reasonably necessary for the immediate protection of subject safety; and

(c) Any breach by the Site of any representation, warranty, covenant, or obligation under the MCTA or this Individual Site Agreement.

The Site's indemnification obligation under this Section 5.4 shall be subject to a cap of Five Million Dollars ($5,000,000.00) per site per occurrence and an aggregate cap across all Veridian Health Research Network sites of Twenty Million Dollars ($20,000,000.00).

Section 5.5 — Notice Requirements. Any Party seeking indemnification under this Article 5 (an "Indemnified Party") shall provide written notice to the Party from whom indemnification is sought (the "Indemnifying Party") within thirty (30) calendar days of becoming aware of any claim, demand, action, suit, or proceeding for which indemnification may be sought under this Agreement. Such notice shall include a reasonable description of the claim, the basis for the indemnification request, and, to the extent known, the estimated amount of the Losses. Failure to provide timely notice shall not relieve the Indemnifying Party of its indemnification obligations hereunder, except to the extent that the Indemnifying Party demonstrates that it has been materially prejudiced by the delay in receiving such notice.

Section 5.6 — Defense and Settlement. The rights and obligations of the parties with respect to the defense and settlement of indemnified claims, including the Indemnifying Party's right to assume the defense of any claim, the Indemnified Party's right to participate in the defense at its own expense, the Indemnifying Party's authority to settle claims (subject to the Indemnified Party's consent, not to be unreasonably withheld, for any settlement that involves the admission of liability or fault by the Indemnified Party or the imposition of non-monetary obligations on the Indemnified Party), and the cooperation obligations of the Indemnified Party, are set forth in detail in Exhibit D to the MCTA and are incorporated herein by reference.

ARTICLE 6 — INSURANCE

Section 6.1 — Sponsor Insurance. The Sponsor represents and warrants that it maintains clinical trial liability insurance coverage with Briarcliff Mutual Insurance Company, under Policy Number BM-CTL-2023-04182, with the following coverage limits:

(a) Per-occurrence limit: Twenty-Five Million Dollars ($25,000,000.00);

(b) Aggregate limit: Seventy-Five Million Dollars ($75,000,000.00);

(c) Subject-injury sublimit: Ten Million Dollars ($10,000,000.00) per occurrence and Fifty Million Dollars ($50,000,000.00) in the aggregate; and

(d) Policy period: April 1, 2023, through March 31, 2024, subject to annual renewal by the Sponsor for the duration of the Study.

Cedar Falls University Hospital and its Site Principal Investigator are named as additional insureds under the Briarcliff Mutual Insurance Company policy for claims arising out of the conduct of Protocol PPC-4871-III at the Site. The Sponsor shall maintain such insurance coverage, or comparable coverage with another nationally recognized insurer, throughout the duration of the Study and for a period of not less than three (3) years following the completion or termination of the Study. The Sponsor shall provide the Site with prompt written notice of any material change in, cancellation of, or non-renewal of such insurance coverage.

Section 6.2 — Site Insurance. Cedar Falls University Hospital shall maintain, at its own expense, the following minimum insurance coverages throughout the duration of the Study and for a period of not less than three (3) years following the completion or termination of the Study at the Site:

(a) Commercial general liability insurance with limits of not less than Five Million Dollars ($5,000,000.00) per occurrence and Ten Million Dollars ($10,000,000.00) in the annual aggregate; and

(b) Professional liability (medical malpractice) insurance with limits of not less than Five Million Dollars ($5,000,000.00) per occurrence and Ten Million Dollars ($10,000,000.00) in the annual aggregate.

The Site shall deliver to the Sponsor a certificate of insurance evidencing the required coverages within fifteen (15) business days of the execution of this Individual Site Agreement, and annually thereafter for the duration of the Study. Each certificate of insurance shall identify the Sponsor as a certificate holder and shall include a provision requiring the insurer to provide the Sponsor with not less than thirty (30) days' prior written notice of any material change in, cancellation of, or non-renewal of such coverage.

Section 6.3 — Certificate Exchange. The Sponsor and the Site shall exchange certificates of insurance within fifteen (15) business days of the Execution Date of this Agreement and annually thereafter for the duration of the Study. Additional certificate exchanges shall occur promptly upon the renewal, replacement, or material modification of any insurance policy required under this Article 6. All certificates of insurance shall be in the form specified in Exhibit E to the MCTA.

ARTICLE 7 — CONFIDENTIALITY AND DATA PROTECTION

Section 7.1 — Confidentiality Obligations. The Site shall comply with all confidentiality obligations set forth in Exhibit F to the MCTA. Without limiting the generality of the foregoing, the Site shall hold in strict confidence and shall not use (except in connection with the conduct of the Study) or disclose to any third party, without the prior written consent of the Sponsor, any Confidential Information (as defined in Exhibit F to the MCTA) received from or on behalf of the Sponsor, the Network, or the CRO in connection with the Study. Confidential Information includes, without limitation, all Protocol-related information, Investigational Product specifications, formulation and manufacturing information, preclinical and clinical data, study results, regulatory strategies, financial terms and budgets, and all other proprietary or non-public information relating to penterafenib, the CLARION trial, or the Sponsor's business. The confidentiality obligations set forth in this Article 7 shall survive the expiration or termination of this Agreement and shall remain in effect for a period of ten (10) years from the date of disclosure of the applicable Confidential Information.

Section 7.2 — Permitted Disclosures. Notwithstanding the foregoing, the confidentiality obligations under this Article 7 shall not apply to the disclosure of Confidential Information:

(a) To the Veridian Central IRB or any local institutional review board, to the extent necessary for the IRB's review and oversight of the Study;

(b) To the FDA or any other governmental or regulatory authority, to the extent required by applicable law, regulation, or compulsory legal process (including, without limitation, subpoena, court order, or regulatory inspection), provided that the Site shall, to the extent legally permissible, provide the Sponsor with prompt written notice of such requirement prior to disclosure and shall cooperate with the Sponsor in seeking a protective order or other appropriate remedy to limit the scope of such disclosure;

(c) To the Site's legal counsel, accountants, auditors, or other professional advisors, in each case under an obligation of confidentiality at least as protective as the obligations set forth herein; and

(d) To site personnel on a need-to-know basis for the conduct of the Study, provided that such personnel have been informed of the confidential nature of the information and have agreed to be bound by confidentiality obligations consistent with this Agreement.

Section 7.3 — HIPAA Compliance. The Site shall comply with the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as amended, and its implementing regulations at 45 C.F.R. Parts 160 and 164, including the Standards for Privacy of Individually Identifiable Health Information (the "Privacy Rule") and the Security Standards for the Protection of Electronic Protected Health Information (the "Security Rule"). Without limiting the foregoing:

(a) The Site shall obtain a valid HIPAA research authorization from each Study subject, or a waiver or alteration of authorization from the Veridian Central IRB, prior to the use or disclosure of any protected health information ("PHI") for research purposes;

(b) The Site shall apply the minimum necessary standard in determining the scope of PHI used or disclosed in connection with the Study;

(c) The Site shall implement appropriate administrative, technical, and physical safeguards to protect the privacy and security of PHI maintained in connection with the Study; and

(d) All sharing of PHI or de-identified data between the Site, the Sponsor, the CRO (Meridian Contract Research Organization, Inc.), and the EDC Platform provider (Pinnacle Data Solutions, Inc.) shall be conducted in accordance with applicable HIPAA requirements and any applicable Business Associate Agreements.

ARTICLE 8 — DATA OWNERSHIP AND INTELLECTUAL PROPERTY

Section 8.1 — Clinical Trial Data Ownership. The Sponsor shall retain exclusive ownership of all clinical trial data, including but not limited to case report forms (whether in paper or electronic format), data entered into the EDC Platform, laboratory data generated by the Central Laboratory, safety data, efficacy data, pharmacokinetic and pharmacodynamic data, biomarker data, and all analyses, reports, and databases derived therefrom, generated under Protocol PPC-4871-III at the Site or at any other participating site. The Site hereby assigns to the Sponsor all right, title, and interest in and to such clinical trial data, to the extent any such right, title, or interest may vest in the Site under applicable law. Notwithstanding the foregoing, the Site shall retain ownership of the original source documents maintained at the Site (e.g., medical records, laboratory reports, imaging studies), subject to the Sponsor's right of access and reference as set forth in the MCTA.

Section 8.2 — Source Document Retention. The Site shall retain all source documents, study records, informed consent forms, IRB correspondence, regulatory submissions, Investigational Product accountability records, and other documentation relating to the conduct of the Study at the Site for a minimum period of fifteen (15) years following the completion of the Study or the termination of this Agreement, whichever is later, or for such longer period as may be required by applicable federal, state, or local law, the requirements of the FDA, ICH GCP Guidelines, or the Sponsor. The Site shall not destroy any such records without providing the Sponsor with at least ninety (90) days' prior written notice and an opportunity to retrieve or copy such records at the Sponsor's expense.

Section 8.3 — Pre-Existing intellectual Property. Each Party retains all right, title, and interest in and to its pre-existing intellectual property, including patents, patent applications, trade secrets, know-how, copyrights, trademarks, and other proprietary rights that existed prior to the Execution Date of this Agreement or that are developed independently of the Study. Nothing in this Agreement shall be construed as granting to any other Party any license or right to use a Party's pre-existing intellectual property, except to the extent expressly provided herein or in the MCTA.

Joint inventions — defined as inventions, discoveries, or innovations that are conceived or first reduced to practice jointly by employees or agents of the Sponsor and employees or agents of the Site during the course of and in connection with the Study — shall be governed by the terms and conditions of the intellectual Property Side Letter executed concurrently with the MCTA on June 28, 2023, by and between the Sponsor and the Network (on behalf of its member institutions). The intellectual Property Side Letter addresses, among other things, the allocation of ownership rights, prosecution and maintenance responsibilities, licensing rights, and revenue-sharing arrangements with respect to joint inventions.

Section 8.4 — Publication Rights. The Site Principal Investigator and sub-investigators shall have the right to publish or present the results of the Study, subject to the following conditions:

(a) Prior to submission of any manuscript, abstract, presentation, or other publication (collectively, a "Publication") for external dissemination, the Site Principal Investigator shall submit a complete copy of the proposed Publication to the Sponsor for review;

(b) The Sponsor shall have a period of sixty (60) calendar days from receipt of the proposed Publication to review the manuscript for the inclusion of any Confidential Information and for the identification of any patentable subject matter;

(c) If the Sponsor identifies Confidential Information in the proposed Publication, the Site Principal Investigator shall remove such Confidential Information prior to submission;

(d) If the Sponsor identifies potentially patentable subject matter in the proposed Publication, the Sponsor may request an additional delay of up to ninety (90) calendar days to allow the Sponsor to file appropriate patent applications prior to public disclosure of such subject matter; and

(e) The Site acknowledges and agrees that multi-center Publications reflecting data from the CLARION trial across multiple participating sites shall be coordinated through the Network and shall be subject to the publication policies set forth in Exhibit G to the MCTA, including the right of the Sponsor and the Network to coordinate the timing and content of multi-site Publications.

ARTICLE 9 — SAFETY REPORTING

Section 9.1 — SAE Reporting. The Site shall report all serious adverse events ("SAEs") occurring in Study subjects enrolled at the Site to the Sponsor and to the CRO (Meridian Contract Research Organization, Inc.) within twenty-four (24) hours of the Site's awareness of the event. For purposes of this Agreement, a "serious adverse event" is 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, results in a congenital anomaly or birth defect, or is a medically important event that may jeopardize the subject or may require medical or surgical intervention to prevent one of the outcomes listed above, consistent with the definitions set forth in 21 C.F.R. § 312.32 and ICH E2A. The procedures for SAE reporting, including the required reporting forms, electronic submission methods, follow-up reporting timelines, and the distribution of SAE reports to the Veridian Central IRB, are set forth in detail in Exhibit J to the MCTA and shall be followed by the Site in all respects.

Section 9.2 — IND Safety Reports. The Sponsor, as the holder of IND 157823 for penterafenib, is solely responsible for the preparation, submission, and distribution of IND safety reports to the FDA in accordance with 21 C.F.R. § 312.32, including: (a) telephone or facsimile reports to the FDA within seven (7) calendar days of initial receipt of information for any adverse event that is both serious and unexpected and results in death or is life-threatening (a "7-day report"); and (b) written reports to the FDA within fifteen (15) calendar days of initial receipt of information for all other adverse events that are both serious and unexpected and are associated with the use of the Investigational Product (a "15-day report"). The Sponsor shall distribute copies of all IND safety reports to the Site Principal Investigator and to the Veridian Central IRB in accordance with the timelines and procedures set forth in Exhibit J to the MCTA.

Section 9.3 — Coordination with CRO. All safety data management activities, including the receipt, processing, coding, assessment, and reporting of adverse events and SAEs, shall be coordinated by and through Meridian Contract Research Organization, Inc., acting on behalf of the Sponsor, in accordance with the safety reporting procedures set forth in Exhibit J to the MCTA and the pharmacovigilance agreement between the Sponsor and the CRO. The Site shall direct all initial SAE reports and follow-up reports to the CRO's pharmacovigilance department using the contact information and submission methods specified in Exhibit J. The CRO shall serve as the Sponsor's agent for purposes of receiving, processing, and transmitting safety information, and the Site may rely on written instructions from the CRO regarding safety reporting procedures to the same extent as if such instructions were provided directly by the Sponsor.

ARTICLE 10 — REGULATORY COMPLIANCE REPRESENTATIONS AND COVENANTS

Section 10.1 — Regulatory Compliance. The Site represents and warrants that it is, and covenants that it shall remain throughout the term of this Agreement, in compliance with all applicable federal, state, and local laws, rules, and regulations governing the conduct of clinical trials and the use of investigational products, including without limitation:

(a) The Federal Food, Drug, and Cosmetic Act, as amended, and the regulations of the FDA promulgated thereunder, including 21 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 Guideline for Good Clinical Practice, ICH E6(R2);

(d) The Physician Payments Sunshine Act (Section 6002 of the Patient Protection and Affordable Care Act), including the accurate and timely reporting of all payments and transfers of value to covered recipients;

(e) The Health Insurance Portability and Accountability Act of 1996, as amended, and its implementing regulations at 45 C.F.R. Parts 160 and 164;

(f) The Common Rule for the Protection of Human Subjects (45 C.F.R. Part 46), to the extent applicable; and

(g) All applicable Colorado state laws and regulations governing the conduct of clinical research, the protection of human subjects, and the use of investigational drugs.

Section 10.2 — Financial Disclosure. The Site Principal Investigator and all sub-investigators listed on the FDA Form 1572 shall complete and submit to the Sponsor Financial Disclosure Certifications in accordance with 21 C.F.R. Part 54, disclosing all financial interests, significant payments, equity interests, and proprietary interests (as those terms are defined in 21 C.F.R. § 54.2) held by the investigator, the investigator's spouse, and each dependent child. Such certifications shall be submitted prior to Site activation and shall be promptly updated upon any material change in the disclosed financial interests during the course of the Study and for a period of one (1) year following the completion of the Study. The Site shall cooperate with the Sponsor in the collection, review, and submission of financial disclosure information as required by the FDA.

Section 10.3 — Debarment and Exclusion. The Site represents and warrants that neither Cedar Falls University Hospital nor any of its officers, directors, employees, investigators, sub-investigators, or site staff members who will be involved in the conduct of the Study is currently, or has ever been: (a) debarred, suspended, proposed for debarment, or otherwise ineligible to participate in Federal procurement or non-procurement programs under the Generic Drug Enforcement Act of 1992 (21 U.S.C. § 335a) or any other applicable federal law; (b) excluded, suspended, or otherwise ineligible to participate in any Federal healthcare program (including Medicare and Medicaid) as listed on the U.S. Department of Health and Human Services, Office of Inspector General List of Excluded Individuals/Entities (LEIE) or the General Services Administration System for Award Management (SAM) exclusion list; or (c) the subject of any pending or threatened investigation or proceeding that could result in any such debarment or exclusion. The Site shall promptly notify the Sponsor in writing if any such debarment, exclusion, or disqualification occurs or is threatened during the term of this Agreement.

ARTICLE 11 — TERM, TERMINATION, AND WIND-DOWN

Section 11.1 — Term. This Individual Site Agreement shall become effective upon the later of (a) the date on which this Agreement is fully executed by all Parties (the "Execution Date") or (b) the Effective Date of the MCTA (July 18, 2023), and shall remain in effect until the earlier of: (i) the completion of all Study activities at the Site, including the collection and entry of all data, resolution of all data queries, return or destruction of all unused Investigational Product, and completion of all close-out activities; or (ii) the termination of this Agreement in accordance with the provisions of this Article 11 (the "Term").

Section 11.2 — Termination. This Individual Site Agreement may be terminated under the following circumstances:

(a) Termination by the Sponsor: The Sponsor may terminate this Agreement, with or without cause, upon ninety (90) days' prior written notice to the Site and the Network. In the event of termination by the Sponsor, the wind-down provisions of Section 11.2(d) shall apply.

(b) Termination by the Site: The Site may terminate this Agreement upon ninety (90) days' prior written notice to the Sponsor and the Network, provided that the Site shall comply with the wind-down provisions of Section 11.2(d) and shall ensure the safety and continuity of care of all subjects enrolled at the Site.

(c) Termination for Cause: Either Party may terminate this Agreement immediately upon written notice in the event of a material breach by the other Party that remains uncured for a period of thirty (30) days following written notice specifying the nature of the breach, or immediately in the event of a breach that is not susceptible to cure (including, without limitation, fraud, scientific misconduct, debarment or exclusion of the Site or any investigator, or a determination by the FDA or the IRB that the Study at the Site must be suspended or terminated).

(d) Wind-Down Period: In the event of any termination under this Section 11.2, the Site shall have a wind-down period of one hundred twenty (120) calendar days from the effective date of termination to ensure the safety and continuity of care of all Study subjects. During the wind-down period, the Site shall: (i) continue to provide medical care to all subjects in active treatment at the Site; (ii) transition subjects to alternative care or, with the Sponsor's written approval, permit subjects to complete their current treatment cycle; (iii) complete all required safety follow-up assessments; (iv) enter all outstanding data into the EDC Platform; (v) return or account for all unused Investigational Product; and (vi) cooperate with the CRO in the completion of close-out monitoring activities.

Section 11.3 — Effect of Termination. The expiration or termination of this Agreement shall not relieve any Party of any obligations that have accrued prior to the effective date of such expiration or termination, including without limitation: (a) indemnification obligations under Article 5; (b) confidentiality obligations under Article 7; (c) data ownership rights under Article 8; (d) record retention requirements under Section 8.2; (e) payment obligations for services rendered and milestones achieved prior to termination; (f) insurance obligations under Article 6 (to the extent of the required post-termination tail coverage period); and (g) obligations to cooperate with regulatory authorities in connection with inspections, audits, or inquiries relating to the Study. The provisions of Articles 5, 7, 8, 10, and 12, and Sections 8.2, 11.3, and 14.1 through 14.6, shall survive the expiration or termination of this Agreement.

ARTICLE 12 — DISPUTE RESOLUTION

Section 12.1 — Governing Law. This Individual Site Agreement and the MCTA shall be governed by and construed in accordance with the laws of the State of New York, without regard to its conflict of laws principles. The Parties agree that the United Nations Convention on Contracts for the International Sale of Goods shall not apply to this Agreement.

Section 12.2 — Escalation Procedure. Any dispute, controversy, or claim arising out of or relating to this Agreement, the MCTA, or the breach, termination, or validity thereof (a "Dispute") shall be resolved in accordance with the following escalation procedure:

(a) Negotiation. The Parties shall first attempt to resolve the Dispute through good-faith negotiations between designated senior representatives of each Party. Within ten (10) business days of written notice of a Dispute, each Party shall designate a senior representative with authority to negotiate a resolution, and such representatives shall meet (in person or by videoconference) and negotiate in good faith for a period of thirty (30) calendar days (the "Negotiation Period").

(b) Mediation. If the Dispute is not resolved during the Negotiation Period, either Party may submit the Dispute to mediation administered by the American Arbitration Association ("AAA") under its Commercial Mediation Procedures. The mediation shall be conducted in New York, New York, by a single mediator selected in accordance with the AAA Commercial Mediation Procedures. The Parties shall participate in the mediation in good faith for a period of sixty (60) calendar days from the appointment of the mediator (the "Mediation Period"). The costs of mediation shall be shared equally by the Parties.

(c) Binding Arbitration. If the Dispute is not resolved during the Mediation Period, either Party may submit the Dispute to final and binding arbitration administered by the AAA under its Commercial Arbitration Rules. The arbitration shall be conducted in New York, New York, before a panel of three (3) arbitrators selected in accordance with the AAA Commercial Arbitration Rules. The arbitrators shall have experience in pharmaceutical and clinical trial matters. The arbitral award shall be final and binding on the Parties and may be entered and enforced in any court of competent jurisdiction. The costs of arbitration shall be allocated by the arbitral panel in accordance with the AAA Commercial Arbitration Rules.

Section 12.3 — Injunctive Relief. Notwithstanding the foregoing, either Party may seek injunctive or other equitable relief from the state and federal courts located in the County of New York, State of New York, to prevent irreparable harm pending the outcome of the dispute resolution procedures set forth in this Article 12. Each Party hereby consents to the exclusive jurisdiction and venue of such courts for purposes of injunctive or equitable relief and waives any objection to such jurisdiction or venue on the grounds of inconvenient forum or otherwise.

ARTICLE

INDIVIDUAL SITE AGREEMENT (JOINDER)
Site Number 004 — Cedar Falls University Hospital
Protocol PPC-4871-III (CLARION — Clinical Assessment of Response with Longitudinal Investigation in ONcology)
Investigational Product: Penterafenib (PPC-4871) ClinicalTrials.gov Identifier: NCT05928174 IND Number: IND 157823
This Individual Site Agreement (this "Agreement" or "ISA") is entered into as of June 28, 2023 (the "Execution Date"), as a joinder to the Master Clinical Trial Agreement dated June 28, 2023 (the "MCTA") between Penterra Pharmaceuticals Corp. ("Sponsor") and Veridian Health Research Network, Inc. ("Network"), and is entered into by and among the following parties:
PARTIES
PENTERRA PHARMACEUTICALS CORP. ("Sponsor"), 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;
VERIDIAN HEALTH RESEARCH NETWORK, INC. ("Network"), a corporation organized and existing under the laws of the State of Delaware and 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; and
CEDAR FALLS UNIVERSITY HOSPITAL ("Site" or "Institution"), a nonprofit corporation organized and existing under the laws of the State of Colorado, and a member institution of the Veridian Health Research Network, with its principal offices located at 1800 Cedar Falls Drive, Denver, Colorado 80204.
Each of the Sponsor, the Network, and the Site is sometimes referred to herein individually as a "Party" and collectively as the "Parties."
RECITALS
WHEREAS (Recital A), the Sponsor and the Network have entered into a Master Clinical Trial Agreement dated June 28, 2023 (the "MCTA"), which governs the conduct of Protocol PPC-4871-III, titled "CLARION — Clinical Assessment of Response with Longitudinal Investigation in ONcology," a Phase III, randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of penterafenib (PPC-4871) in the treatment of advanced hepatocellular carcinoma (HCC) in patients who have progressed on or are intolerant to at least one prior line of systemic therapy, including but not limited to atezolizumab plus bevacizumab, sorafenib, or lenvatinib;
WHEREAS (Recital B), Cedar Falls University Hospital is a member institution of the Veridian Health Research Network and has agreed to participate as an individual clinical trial site, designated as Site 004, under the terms and conditions of the MCTA, and the Site will screen, enroll, randomize, and treat subjects in accordance with Protocol PPC-4871-III and all applicable regulatory requirements;
WHEREAS (Recital C), this Individual Site Agreement constitutes a joinder to the MCTA pursuant to Exhibit C thereof (Form of Individual Site Agreement/Joinder), and by execution hereof, the Site agrees to be bound by all terms and conditions of the MCTA as if the Site were an original signatory thereto, with the MCTA incorporated herein by reference as if fully set forth in this Agreement;
WHEREAS (Recital D), the Site will rely on the Veridian Central Institutional Review Board (the "Veridian Central IRB") for institutional review board oversight of Protocol PPC-4871-III at this Site, pursuant to an IRB Authorization Agreement to be executed between Cedar Falls University Hospital and the Veridian Central IRB in accordance with 45 C.F.R. § 46.114 and applicable FDA regulations, and the Site acknowledges that no subjects may be enrolled at the Site until such IRB Authorization Agreement is fully executed and all required IRB approvals have been obtained; and
WHEREAS (Recital E), penterafenib (PPC-4871) is an orally administered multi-kinase inhibitor targeting FGFR1-4, VEGFR1-3, and PDGFR-α/β, for which the Sponsor filed an Investigational New Drug Application with the United States Food and Drug Administration ("FDA") in October 2021 (IND 157823), and for which a Phase II clinical trial was completed in January 2023, demonstrating an objective response rate (ORR) of thirty-eight percent (38%) per RECIST v1.1 in patients with advanced HCC, with a manageable safety profile, and the Sponsor, as the IND holder, is responsible for all IND-related regulatory obligations with respect to penterafenib;
NOW, THEREFORE, in consideration of the mutual covenants 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 1 — DEFINITIONS AND INTERPRETATION
Section 1.1 — Definitions. All capitalized terms used but not otherwise defined in this Individual Site Agreement shall have the meanings ascribed to such terms in the MCTA. For purposes of clarity and convenience, the following defined terms are reiterated or supplemented herein:
(a) "Central Laboratory" means Northbridge Bioanalytical Laboratories, Inc., the Sponsor's designated central laboratory for the CLARION trial, responsible for pharmacokinetic/pharmacodynamic (PK/PD) analyses, biomarker assessments, and safety laboratory analyses.
(b) "CRO" means Meridian Contract Research Organization, Inc., the Sponsor's contracted full-service contract research organization for the CLARION trial, providing clinical monitoring, data management, pharmacovigilance and safety reporting, biostatistical analysis, and regulatory support services.
(c) "EDC Platform" means the electronic data capture system provided by Pinnacle Data Solutions, Inc., as designated by the Sponsor for the collection, management, and transmission of clinical trial data under Protocol PPC-4871-III.
(d) "Investigational Product" or "IP" means penterafenib (PPC-4871), including all formulations, dosage forms, and packaging thereof supplied by the Sponsor for use in Protocol PPC-4871-III.
(e) "MCTA" means the Master Clinical Trial Agreement dated June 28, 2023, by and between the Sponsor and the Network, as the same may be amended, supplemented, or modified from time to time in accordance with its terms.
(f) "Network" means Veridian Health Research Network, Inc., a Delaware corporation and 501(c)(3) tax-exempt research organization.
(g) "Protocol" means Protocol PPC-4871-III (CLARION — Clinical Assessment of Response with Longitudinal Investigation in ONcology), including all amendments and administrative letters thereto approved by the Sponsor and the relevant IRB.
(h) "Site Principal Investigator" or "PI" means the physician designated in Schedule A to this Agreement as the principal investigator responsible for the conduct of Protocol PPC-4871-III at the Site.
(i) "Study" means the Phase III, randomized, double-blind, placebo-controlled clinical trial of penterafenib conducted under Protocol PPC-4871-III and IND 157823.
(j) "Veridian Central IRB" means the central institutional review board established and operated by the Veridian Health Research Network for the purpose of providing centralized IRB oversight of clinical trials conducted across Veridian Network member institutions.
Section 1.2 — Interpretation. In this Agreement, unless the context otherwise requires: (a) the singular includes the plural and vice versa; (b) references to "Articles," "Sections," "Schedules," and "Exhibits" are to the articles, sections, schedules, and exhibits of or to this Agreement unless otherwise specified; (c) the words "include," "includes," and "including" shall be deemed to be followed by the phrase "without limitation"; (d) references to any law, statute, or regulation shall be construed as including all statutory and regulatory provisions consolidating, amending, replacing, supplementing, or interpreting such law, statute, or regulation; and (e) headings and captions are for convenience of reference only and shall not affect the interpretation of this Agreement.
Section 1.3 — Order of Precedence. In the event of any conflict or inconsistency among the documents comprising the agreement between the Parties, the following order of precedence shall apply, from highest to lowest priority: (a) this Individual Site Agreement (with respect to Site-specific matters only); (b) the MCTA; (c) the Protocol; and (d) the Exhibits and Schedules to the MCTA and this Agreement. For the avoidance of doubt, in all matters that are not Site-specific, the terms of the MCTA shall govern and control.
ARTICLE 2 — INCORPORATION OF MCTA TERMS
Section 2.1 — Full Incorporation. All terms, conditions, obligations, rights, representations, warranties, covenants, and remedies set forth in the MCTA are hereby incorporated into this Individual Site Agreement by reference in their entirety and shall be binding on the Site, the Site Principal Investigator, and all site personnel as though the Site were an original signatory party to the MCTA. By executing this Agreement, the Site acknowledges that it has received, reviewed, and agreed to be bound by all provisions of the MCTA. The Network shall make available to the Site a complete copy of the fully executed MCTA, together with all Exhibits and Schedules thereto, within five (5) business days of the Execution Date of this Agreement. In the event of any conflict between the terms of this Individual Site Agreement and the terms of the MCTA, the terms of this Individual Site Agreement shall control solely with respect to Site-specific matters, including but not limited to Site-specific enrollment allocations, Site-specific budget and payment terms, Site-specific regulatory information, and the designation of the Site Principal Investigator. In all other respects, the terms of the MCTA shall govern and control.
Section 2.2 — MCTA Exhibits and Schedules Applicable to Site. The following Exhibits and Schedules to the MCTA are hereby incorporated into this Individual Site Agreement by reference and are applicable to the Site:
(a) Exhibit A — Protocol Synopsis (Protocol PPC-4871-III, CLARION);
(b) Exhibit B — Budget and Payment Schedule, as supplemented and further specified by Schedule B to this Agreement with respect to Site-specific financial terms;
(c) Exhibit D — Subject-Injury Indemnification Provisions, including detailed procedures for the identification, reporting, and management of study-related injuries and the allocation of financial responsibility therefor;
(d) Exhibit E — Insurance Requirements and Certificate Forms, specifying the minimum insurance coverage requirements for the Sponsor, the Network, and each participating Site;
(e) Exhibit F — Confidentiality and Data Protection Provisions, setting forth the obligations of all parties with respect to the protection of confidential information, trade secrets, and proprietary data;
(f) Exhibit G — Intellectual Property and Publication Rights, governing the ownership of inventions, data, and intellectual property arising from the Study and the rights of investigators and the Sponsor with respect to the publication of Study results;
(g) Exhibit H — Regulatory Compliance Representations and Covenants, including representations regarding compliance with FDA regulations, ICH GCP Guidelines, the Anti-Kickback Statute, and other applicable laws;
(h) Exhibit I — Form of Investigator Undertaking, to be executed by the Site Principal Investigator prior to enrollment of any subjects;
(i) Exhibit J — Safety Reporting Procedures, detailing the procedures and timelines for the reporting of adverse events, serious adverse events, and other safety information; and
(j) Exhibit K — Approved Subcontractors List, identifying all third-party service providers authorized to perform services in connection with the CLARION trial.
ARTICLE 3 — SCOPE OF WORK AND SITE OBLIGATIONS
Section 3.1 — Conduct of the Study. The Site shall conduct Protocol PPC-4871-III (CLARION) in strict accordance with the Protocol and all amendments thereto, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guideline for Good Clinical Practice, ICH E6(R2) (the "ICH GCP Guidelines"), all applicable regulations of the United States Food and Drug Administration (the "FDA"), including without limitation 21 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), and all applicable federal, state, and local laws, rules, and regulations. The Site shall ensure that the conduct of the Study at the Site meets the highest standards of scientific rigor, ethical practice, and regulatory compliance.
The Study is designed as a Phase III, randomized, double-blind, placebo-controlled, multi-center clinical trial. The planned total enrollment across all thirty-eight (38) participating Veridian Health Research Network sites is one thousand two hundred (1,200) subjects, randomized in a 2:1 ratio (penterafenib to placebo), resulting in an allocation of approximately eight hundred (800) subjects to the penterafenib treatment arm and approximately four hundred (400) subjects to the placebo control arm. The primary endpoint of the Study is overall survival (OS); secondary endpoints include progression-free survival (PFS), objective response rate (ORR) per RECIST v1.1, duration of response (DOR), and safety and tolerability assessments. The Site's individual enrollment allocation is as set forth in Schedule B to this Agreement. The Site shall use commercially reasonable efforts to achieve its allocated enrollment targets within the projected enrollment period described in Section 3.6 of this Article.
Section 3.2 — Site Principal Investigator. The Site Principal Investigator designated in Schedule A to this Agreement shall be responsible for the overall medical conduct of the trial at the Site, including but not limited to: (a) obtaining and documenting informed consent from each prospective subject in accordance with 21 C.F.R. Part 50 and the requirements of the Veridian Central IRB; (b) ensuring the safety, welfare, and rights of all subjects enrolled at the Site; (c) ensuring compliance with all Protocol requirements, including subject eligibility assessments, treatment administration, efficacy and safety evaluations, and follow-up procedures; (d) timely reporting of adverse events, serious adverse events, and other safety information in accordance with Article 9 of this Agreement and Exhibit J to the MCTA; (e) maintaining complete, accurate, and contemporaneous source documentation and case report forms; (f) overseeing the proper handling, storage, dispensing, accountability, and return or destruction of the Investigational Product at the Site; and (g) supervising all sub-investigators and site staff in the performance of their delegated trial-related duties.
Prior to the enrollment of any subjects at the Site, the Site Principal Investigator shall: (i) execute the Form of Investigator Undertaking attached as Exhibit I to the MCTA; (ii) execute and submit an FDA Form 1572 (Statement of Investigator) to the Sponsor; and (iii) complete and submit a Financial Disclosure Certification in accordance with the requirements of 21 C.F.R. Part 54, disclosing any financial interests, arrangements, or other relationships that could affect the objectivity of the investigator in the conduct of the Study. The Site Principal Investigator shall promptly notify the Sponsor in writing of any material change in his or her financial interests or arrangements during the course of the Study and for one (1) year following the completion of the Study.
Section 3.3 — Sub-Investigators and Site Personnel. All sub-investigators and study coordinators involved in the conduct of Protocol PPC-4871-III at the Site must be identified on the FDA Form 1572 filed by the Site Principal Investigator and must be qualified by education, training, and experience to perform their respective delegated trial-related duties. The Site shall maintain a current and accurate delegation of authority log (the "Delegation Log") for each sub-investigator and research staff member, documenting the specific tasks delegated to each individual by the Site Principal Investigator. The Delegation Log shall be updated promptly upon any change in personnel or delegation of duties and shall be made available to the Sponsor, the CRO, and the Veridian Central IRB upon request. All sub-investigators shall complete and submit Financial Disclosure Certifications under 21 C.F.R. Part 54 in the same manner as the Site Principal Investigator. The Site shall ensure that all site personnel involved in the conduct of the Study have received adequate training on the Protocol, ICH GCP Guidelines, applicable regulatory requirements, human subjects protection, and the proper use of the EDC Platform prior to performing any study-related duties.
Section 3.4 — IRB Oversight. The Site shall rely on the Veridian Central IRB as its IRB of record for Protocol PPC-4871-III. The Site acknowledges that the Veridian Central IRB will serve as the reviewing IRB responsible for the initial and continuing review of the Protocol, informed consent documents, recruitment materials, and all other study-related materials requiring IRB review and approval. An IRB Authorization Agreement between Cedar Falls University Hospital and the Veridian Central IRB, compliant with the requirements of 45 C.F.R. § 46.114 and the FDA's guidance on IRB reliance arrangements, must be fully executed and in place prior to the enrollment of any subjects at the Site. The Site shall cooperate with the Veridian Central IRB and shall promptly provide any information or documentation requested by the Veridian Central IRB in connection with its review of the Study.
The Site shall ensure that all required IRB approvals, including initial approval, continuing reviews (conducted at intervals not exceeding twelve (12) months), and approvals of Protocol amendments, informed consent revisions, and other study-related modifications, are obtained and maintained throughout the duration of the Study at the Site. The Site shall promptly report to the Veridian Central IRB all unanticipated problems involving risks to subjects or others, all serious adverse events that are both unexpected and related to the Investigational Product, and any instances of non-compliance with the Protocol or applicable regulations, in accordance with the reporting requirements established by the Veridian Central IRB and 21 C.F.R. Part 56. The Site shall also comply with any local institutional requirements for notification to a local IRB or institutional official, to the extent such requirements are not superseded by the IRB Authorization Agreement.
Section 3.5 — Approved Subcontractors. The Site acknowledges and agrees that the following approved subcontractors have been engaged by the Sponsor to provide services in connection with the CLARION trial, and the Site shall cooperate with such subcontractors in the performance of their respective duties:
(a) Meridian Contract Research Organization, Inc. (the "CRO"), which will provide clinical monitoring services (including on-site monitoring visits, remote monitoring, and source data verification), clinical data management, pharmacovigilance and safety reporting coordination, biostatistical analysis, and regulatory support services;
(b) Pinnacle Data Solutions, Inc., which will provide the EDC Platform used for the electronic capture, management, validation, and transmission of clinical trial data collected at the Site; and
(c) Northbridge Bioanalytical Laboratories, Inc. (the "Central Laboratory"), which will perform all centralized laboratory analyses, including pharmacokinetic and pharmacodynamic assessments, exploratory biomarker analyses (including circulating tumor DNA, alpha-fetoprotein kinetics, and FGFR pathway biomarkers), and safety laboratory evaluations (hematology, serum chemistry, coagulation, and urinalysis).
The Site shall facilitate the performance of monitoring visits by Meridian CRO clinical research associates, including providing adequate workspace, access to source documents and study records, and access to study subjects as reasonably requested. The Site shall ensure that all study data are entered into the EDC Platform in a timely, accurate, and complete manner and shall cooperate with Pinnacle Data Solutions in the resolution of data queries. The Site shall ensure that all laboratory specimens are collected, processed, labeled, stored, and shipped to the Central Laboratory in accordance with the laboratory manual provided by Northbridge Bioanalytical Laboratories.
Section 3.6 — Study Timeline. The projected timelines for the CLARION trial are as follows:
(a) Target First Patient In (FPI) across all sites: August 14, 2023;
(b) Projected enrollment period: Forty-two (42) months from FPI (projected Last Patient In: February 2027);
(c) Estimated total study duration: Sixty (60) months from FPI (projected study completion, including final database lock and study report: August 2028); and
(d) Site-specific activation target: The Site shall use commercially reasonable efforts to complete all Site activation requirements (including execution of this Agreement, IRB approval, site initiation visit, and resolution of any regulatory or operational pre-activation conditions) and to achieve its first patient enrolled within ninety (90) days of the Execution Date of this Agreement.
The Site shall use commercially reasonable efforts to achieve its allocated enrollment targets within the projected enrollment period. If the Site's enrollment falls materially below its allocated target, the Sponsor reserves the right, upon consultation with the Network, to reallocate enrollment among participating sites or to terminate this Agreement in accordance with Article 11, subject to the wind-down provisions therein.
ARTICLE 4 — FINANCIAL TERMS AND PAYMENT
Section 4.1 — Budget. The Site shall be compensated for the conduct of Protocol PPC-4871-III in accordance with the budget set forth in Schedule B to this Agreement, which is consistent with and supplements the budget framework established in Exhibit B to the MCTA. The total aggregate budget for the CLARION trial across all thirty-eight (38) participating Veridian Health Research Network sites is Eighty Million Dollars ($80,000,000.00). The Site's individual share of such aggregate budget shall be determined by the Site's allocated enrollment target and actual enrollment and is as set forth in detail in Schedule B. All payments to the Site shall be made through the Network in accordance with the invoicing and payment procedures set forth in this Article and in the MCTA.
Section 4.2 — Start-Up Fees. The Sponsor shall pay to the Site a one-time start-up fee of Seventy-Five Thousand Dollars ($75,000.00) to defray costs associated with Site activation, including regulatory submissions, staff training, equipment calibration, pharmacy set-up, and other Site readiness activities. The start-up fee shall be paid in two (2) equal installments as follows:
(a) Fifty percent (50%) of the start-up fee (Thirty-Seven Thousand Five Hundred Dollars ($37,500.00)) shall be payable upon Site activation, defined as the date on which the Site has satisfied all pre-activation requirements (including execution of this Agreement, IRB approval, completed site initiation visit, and confirmation by the CRO that the Site is ready to enroll); and
(b) Fifty percent (50%) of the start-up fee (Thirty-Seven Thousand Five Hundred Dollars ($37,500.00)) shall be payable upon the enrollment (randomization) of the first subject at the Site.
Section 4.3 — Per-Patient Site Fees. The Sponsor shall pay to the Site a per-patient fee of Fifty-Two Thousand Dollars ($52,000.00) for each subject who is screened and enrolled (randomized) at the Site, payable on a milestone-based payment schedule as follows:
(a) Randomization Milestone: Twenty-five percent (25%) of the per-patient fee (Thirteen Thousand Dollars ($13,000.00)) shall be payable upon the randomization of the subject;
(b) Week 12 Assessment Milestone: Twenty-five percent (25%) of the per-patient fee (Thirteen Thousand Dollars ($13,000.00)) shall be payable upon the completion of the Week 12 efficacy and safety assessment for the subject;
(c) Week 24 Assessment Milestone: Twenty-five percent (25%) of the per-patient fee (Thirteen Thousand Dollars ($13,000.00)) shall be payable upon the completion of the Week 24 efficacy and safety assessment for the subject; and
(d) Study Completion / Final Visit Milestone: Twenty-five percent (25%) of the per-patient fee (Thirteen Thousand Dollars ($13,000.00)) shall be payable upon the completion of the subject's final study visit or upon the subject's early termination from the Study, provided that all required end-of-treatment and follow-up procedures have been completed as specified in the Protocol.
For subjects who withdraw from the Study or are lost to follow-up prior to achieving a payment milestone, the Site shall be compensated on a prorated basis for services actually rendered, calculated in accordance with the procedures set forth in Schedule B.
Section 4.4 — Annual Site Maintenance Fees. The Sponsor shall pay to the Site an annual site maintenance fee of Forty Thousand Dollars ($40,000.00) per year to cover ongoing costs associated with the maintenance of the Site's participation in the Study, including but not limited to staff retention, equipment maintenance, regulatory compliance, record storage, and continuing education. The annual site maintenance fee shall be paid in advance on each anniversary of the date of Site activation. Based on the projected average duration of Site participation of approximately three and one-half (3.5) years, the estimated total site maintenance fees payable to the Site are One Hundred Forty Thousand Dollars ($140,000.00), subject to actual duration of participation.
Section 4.5 — Payment Terms. All payments under this Agreement shall be made within forty-five (45) calendar days from the Sponsor's receipt of a proper and complete invoice submitted by the Site through the Network. Invoices shall include: the Site number (004), the Protocol number (PPC-4871-III), the applicable milestone or fee description, the period of service, the amount invoiced, and supporting documentation as reasonably required by the Sponsor. Invoices shall be submitted to:
Samantha Novak Director, Clinical Contracts Penterra Pharmaceuticals Corp. 200 Biopharma Boulevard, Suite 1400 Princeton, New Jersey 08540
Email: s.novak@penterra.com
or to such other person or address as the Sponsor may designate in writing from time to time. All payments shall be made by wire transfer or electronic funds transfer (EFT) to the bank account designated by the Site in writing. The Site shall be responsible for all applicable taxes (excluding Sponsor's income taxes) on payments received hereunder.
Section 4.6 — Fair Market Value. The Site and the Site Principal Investigator represent and warrant that all compensation payable under this Agreement reflects fair market value for the services to be rendered and the time, effort, and expertise required, and that such compensation has been determined through arm's-length negotiations and does not take into account the volume or value of any referrals of patients, subjects, or services between the parties. The Site and the Site Principal Investigator further represent and warrant that the financial arrangements set forth herein do not constitute, and are not intended to constitute, any inducement, reward, or payment for the referral of subjects, patients, or services, and are consistent with the requirements of the Federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b) and all applicable safe harbor regulations promulgated thereunder. All payments to physicians and teaching hospitals shall be reported as required under Section 6002 of the Patient Protection and Affordable Care Act (the "Physician Payments Sunshine Act" or "Open Payments"), and the Site and the Site Principal Investigator shall cooperate with the Sponsor in ensuring the accuracy and completeness of all such reports.
ARTICLE 5 — INDEMNIFICATION
Section 5.1 — Sponsor Indemnification of Site and Investigators. Subject to the terms and conditions of this Article 5 and the provisions of Exhibit D to the MCTA, the Sponsor shall defend, indemnify, and hold harmless Cedar Falls University Hospital, its officers, directors, trustees, employees, agents, the Site Principal Investigator, all sub-investigators, and all site staff (collectively, the "Site Indemnified Parties") from and against any and all claims, demands, actions, suits, proceedings, losses, damages, liabilities, costs, and expenses (including reasonable attorneys' fees and costs of litigation) (collectively, "Losses") arising from or related to:
(a) Any injury, illness, death, or adverse event suffered by a Study subject that is caused by the Investigational Product (penterafenib, PPC-4871) when administered in accordance with the Protocol and the applicable informed consent;
(b) Any defect in the design, manufacture, formulation, labeling, packaging, storage, or shipment of the Investigational Product, including any failure to comply with current Good Manufacturing Practices (cGMP) or applicable FDA regulations;
(c) Any breach by the Sponsor of any representation, warranty, covenant, or obligation under the MCTA, this Individual Site Agreement, or the Protocol; and
(d) Any negligence, gross negligence, or willful misconduct of the Sponsor, its employees, agents, or representatives (including the CRO, to the extent acting within the scope of its engagement by the Sponsor) in connection with the Study.
Section 5.2 — Carve-Outs from Sponsor Indemnification. Notwithstanding the foregoing, the Sponsor's indemnification obligations under Section 5.1 shall not apply to the extent that Losses arise from or are attributable to:
(i) The negligence, gross negligence, or willful misconduct of the Site, the Site Principal Investigator, any sub-investigator, or any site personnel in the conduct of the Study;
(ii) Any deviation from the Protocol by the Site, the Site Principal Investigator, or site personnel that was not authorized in advance by the Sponsor in writing and was not reasonably necessary for the immediate protection of subject safety; or
(iii) Any breach by the Site, the Site Principal Investigator, or site personnel of any representation, warranty, covenant, or obligation under the MCTA, this Individual Site Agreement, or applicable law, including but not limited to failures to obtain proper informed consent, failures to comply with IRB requirements, and unauthorized use or disclosure of confidential information.
Section 5.3 — Subject Medical Care. In the event that a Study subject experiences a study-related injury (defined as an injury that is directly and proximately caused by the administration of the Investigational Product in accordance with the Protocol or by a study-required procedure), the Sponsor shall cover the reasonable and customary medical costs for the diagnosis and treatment of such injury to the extent that such costs are not covered by the subject's health insurance or other third-party coverage. The Sponsor's obligation under this Section 5.3 is subject to a per-subject cap of Five Hundred Thousand Dollars ($500,000.00) and an aggregate cap across all participating Veridian Network sites of Fifteen Million Dollars ($15,000,000.00). Claims arising from a defect in the Investigational Product (as described in Section 5.1(b)) are separately covered under the Sponsor's general indemnification obligation and are not subject to the per-subject or aggregate caps set forth in this Section 5.3. The procedures for reporting, documenting, and adjudicating claims for study-related injury medical costs are set forth in Exhibit D to the MCTA.
Section 5.4 — Site Indemnification of Sponsor. Subject to the terms and conditions of this Article 5 and the provisions of Exhibit D to the MCTA, Cedar Falls University Hospital shall defend, indemnify, and hold harmless the Sponsor, its officers, directors, employees, agents, and affiliates (collectively, the "Sponsor Indemnified Parties") from and against any and all Losses arising from or related to:
(a) The negligence, gross negligence, or willful misconduct of the Site, the Site Principal Investigator, any sub-investigator, or any site personnel in the conduct of the Study;
(b) Any deviation from the Protocol by the Site, the Site Principal Investigator, or site personnel that was not authorized in advance by the Sponsor in writing and was not reasonably necessary for the immediate protection of subject safety; and
(c) Any breach by the Site of any representation, warranty, covenant, or obligation under the MCTA or this Individual Site Agreement.
The Site's indemnification obligation under this Section 5.4 shall be subject to a cap of Five Million Dollars ($5,000,000.00) per site per occurrence and an aggregate cap across all Veridian Health Research Network sites of Twenty Million Dollars ($20,000,000.00).
Section 5.5 — Notice Requirements. Any Party seeking indemnification under this Article 5 (an "Indemnified Party") shall provide written notice to the Party from whom indemnification is sought (the "Indemnifying Party") within thirty (30) calendar days of becoming aware of any claim, demand, action, suit, or proceeding for which indemnification may be sought under this Agreement. Such notice shall include a reasonable description of the claim, the basis for the indemnification request, and, to the extent known, the estimated amount of the Losses. Failure to provide timely notice shall not relieve the Indemnifying Party of its indemnification obligations hereunder, except to the extent that the Indemnifying Party demonstrates that it has been materially prejudiced by the delay in receiving such notice.
Section 5.6 — Defense and Settlement. The rights and obligations of the parties with respect to the defense and settlement of indemnified claims, including the Indemnifying Party's right to assume the defense of any claim, the Indemnified Party's right to participate in the defense at its own expense, the Indemnifying Party's authority to settle claims (subject to the Indemnified Party's consent, not to be unreasonably withheld, for any settlement that involves the admission of liability or fault by the Indemnified Party or the imposition of non-monetary obligations on the Indemnified Party), and the cooperation obligations of the Indemnified Party, are set forth in detail in Exhibit D to the MCTA and are incorporated herein by reference.
ARTICLE 6 — INSURANCE
Section 6.1 — Sponsor Insurance. The Sponsor represents and warrants that it maintains clinical trial liability insurance coverage with Briarcliff Mutual Insurance Company, under Policy Number BM-CTL-2023-04182, with the following coverage limits:
(a) Per-occurrence limit: Twenty-Five Million Dollars ($25,000,000.00);
(b) Aggregate limit: Seventy-Five Million Dollars ($75,000,000.00);
(c) Subject-injury sublimit: Ten Million Dollars ($10,000,000.00) per occurrence and Fifty Million Dollars ($50,000,000.00) in the aggregate; and
(d) Policy period: April 1, 2023, through March 31, 2024, subject to annual renewal by the Sponsor for the duration of the Study.
Cedar Falls University Hospital and its Site Principal Investigator are named as additional insureds under the Briarcliff Mutual Insurance Company policy for claims arising out of the conduct of Protocol PPC-4871-III at the Site. The Sponsor shall maintain such insurance coverage, or comparable coverage with another nationally recognized insurer, throughout the duration of the Study and for a period of not less than three (3) years following the completion or termination of the Study. The Sponsor shall provide the Site with prompt written notice of any material change in, cancellation of, or non-renewal of such insurance coverage.
Section 6.2 — Site Insurance. Cedar Falls University Hospital shall maintain, at its own expense, the following minimum insurance coverages throughout the duration of the Study and for a period of not less than three (3) years following the completion or termination of the Study at the Site:
(a) Commercial general liability insurance with limits of not less than Five Million Dollars ($5,000,000.00) per occurrence and Ten Million Dollars ($10,000,000.00) in the annual aggregate; and
(b) Professional liability (medical malpractice) insurance with limits of not less than Five Million Dollars ($5,000,000.00) per occurrence and Ten Million Dollars ($10,000,000.00) in the annual aggregate.
The Site shall deliver to the Sponsor a certificate of insurance evidencing the required coverages within fifteen (15) business days of the execution of this Individual Site Agreement, and annually thereafter for the duration of the Study. Each certificate of insurance shall identify the Sponsor as a certificate holder and shall include a provision requiring the insurer to provide the Sponsor with not less than thirty (30) days' prior written notice of any material change in, cancellation of, or non-renewal of such coverage.
Section 6.3 — Certificate Exchange. The Sponsor and the Site shall exchange certificates of insurance within fifteen (15) business days of the Execution Date of this Agreement and annually thereafter for the duration of the Study. Additional certificate exchanges shall occur promptly upon the renewal, replacement, or material modification of any insurance policy required under this Article 6. All certificates of insurance shall be in the form specified in Exhibit E to the MCTA.
ARTICLE 7 — CONFIDENTIALITY AND DATA PROTECTION
Section 7.1 — Confidentiality Obligations. The Site shall comply with all confidentiality obligations set forth in Exhibit F to the MCTA. Without limiting the generality of the foregoing, the Site shall hold in strict confidence and shall not use (except in connection with the conduct of the Study) or disclose to any third party, without the prior written consent of the Sponsor, any Confidential Information (as defined in Exhibit F to the MCTA) received from or on behalf of the Sponsor, the Network, or the CRO in connection with the Study. Confidential Information includes, without limitation, all Protocol-related information, Investigational Product specifications, formulation and manufacturing information, preclinical and clinical data, study results, regulatory strategies, financial terms and budgets, and all other proprietary or non-public information relating to penterafenib, the CLARION trial, or the Sponsor's business. The confidentiality obligations set forth in this Article 7 shall survive the expiration or termination of this Agreement and shall remain in effect for a period of ten (10) years from the date of disclosure of the applicable Confidential Information.
Section 7.2 — Permitted Disclosures. Notwithstanding the foregoing, the confidentiality obligations under this Article 7 shall not apply to the disclosure of Confidential Information:
(a) To the Veridian Central IRB or any local institutional review board, to the extent necessary for the IRB's review and oversight of the Study;
(b) To the FDA or any other governmental or regulatory authority, to the extent required by applicable law, regulation, or compulsory legal process (including, without limitation, subpoena, court order, or regulatory inspection), provided that the Site shall, to the extent legally permissible, provide the Sponsor with prompt written notice of such requirement prior to disclosure and shall cooperate with the Sponsor in seeking a protective order or other appropriate remedy to limit the scope of such disclosure;
(c) To the Site's legal counsel, accountants, auditors, or other professional advisors, in each case under an obligation of confidentiality at least as protective as the obligations set forth herein; and
(d) To site personnel on a need-to-know basis for the conduct of the Study, provided that such personnel have been informed of the confidential nature of the information and have agreed to be bound by confidentiality obligations consistent with this Agreement.
Section 7.3 — HIPAA Compliance. The Site shall comply with the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as amended, and its implementing regulations at 45 C.F.R. Parts 160 and 164, including the Standards for Privacy of Individually Identifiable Health Information (the "Privacy Rule") and the Security Standards for the Protection of Electronic Protected Health Information (the "Security Rule"). Without limiting the foregoing:
(a) The Site shall obtain a valid HIPAA research authorization from each Study subject, or a waiver or alteration of authorization from the Veridian Central IRB, prior to the use or disclosure of any protected health information ("PHI") for research purposes;
(b) The Site shall apply the minimum necessary standard in determining the scope of PHI used or disclosed in connection with the Study;
(c) The Site shall implement appropriate administrative, technical, and physical safeguards to protect the privacy and security of PHI maintained in connection with the Study; and
(d) All sharing of PHI or de-identified data between the Site, the Sponsor, the CRO (Meridian Contract Research Organization, Inc.), and the EDC Platform provider (Pinnacle Data Solutions, Inc.) shall be conducted in accordance with applicable HIPAA requirements and any applicable Business Associate Agreements.
ARTICLE 8 — DATA OWNERSHIP AND INTELLECTUAL PROPERTY
Section 8.1 — Clinical Trial Data Ownership. The Sponsor shall retain exclusive ownership of all clinical trial data, including but not limited to case report forms (whether in paper or electronic format), data entered into the EDC Platform, laboratory data generated by the Central Laboratory, safety data, efficacy data, pharmacokinetic and pharmacodynamic data, biomarker data, and all analyses, reports, and databases derived therefrom, generated under Protocol PPC-4871-III at the Site or at any other participating site. The Site hereby assigns to the Sponsor all right, title, and interest in and to such clinical trial data, to the extent any such right, title, or interest may vest in the Site under applicable law. Notwithstanding the foregoing, the Site shall retain ownership of the original source documents maintained at the Site (e.g., medical records, laboratory reports, imaging studies), subject to the Sponsor's right of access and reference as set forth in the MCTA.
Section 8.2 — Source Document Retention. The Site shall retain all source documents, study records, informed consent forms, IRB correspondence, regulatory submissions, Investigational Product accountability records, and other documentation relating to the conduct of the Study at the Site for a minimum period of fifteen (15) years following the completion of the Study or the termination of this Agreement, whichever is later, or for such longer period as may be required by applicable federal, state, or local law, the requirements of the FDA, ICH GCP Guidelines, or the Sponsor. The Site shall not destroy any such records without providing the Sponsor with at least ninety (90) days' prior written notice and an opportunity to retrieve or copy such records at the Sponsor's expense.
Section 8.3 — Pre-Existing intellectual Property. Each Party retains all right, title, and interest in and to its pre-existing intellectual property, including patents, patent applications, trade secrets, know-how, copyrights, trademarks, and other proprietary rights that existed prior to the Execution Date of this Agreement or that are developed independently of the Study. Nothing in this Agreement shall be construed as granting to any other Party any license or right to use a Party's pre-existing intellectual property, except to the extent expressly provided herein or in the MCTA.
Joint inventions — defined as inventions, discoveries, or innovations that are conceived or first reduced to practice jointly by employees or agents of the Sponsor and employees or agents of the Site during the course of and in connection with the Study — shall be governed by the terms and conditions of the intellectual Property Side Letter executed concurrently with the MCTA on June 28, 2023, by and between the Sponsor and the Network (on behalf of its member institutions). The intellectual Property Side Letter addresses, among other things, the allocation of ownership rights, prosecution and maintenance responsibilities, licensing rights, and revenue-sharing arrangements with respect to joint inventions.
Section 8.4 — Publication Rights. The Site Principal Investigator and sub-investigators shall have the right to publish or present the results of the Study, subject to the following conditions:
(a) Prior to submission of any manuscript, abstract, presentation, or other publication (collectively, a "Publication") for external dissemination, the Site Principal Investigator shall submit a complete copy of the proposed Publication to the Sponsor for review;
(b) The Sponsor shall have a period of sixty (60) calendar days from receipt of the proposed Publication to review the manuscript for the inclusion of any Confidential Information and for the identification of any patentable subject matter;
(c) If the Sponsor identifies Confidential Information in the proposed Publication, the Site Principal Investigator shall remove such Confidential Information prior to submission;
(d) If the Sponsor identifies potentially patentable subject matter in the proposed Publication, the Sponsor may request an additional delay of up to ninety (90) calendar days to allow the Sponsor to file appropriate patent applications prior to public disclosure of such subject matter; and
(e) The Site acknowledges and agrees that multi-center Publications reflecting data from the CLARION trial across multiple participating sites shall be coordinated through the Network and shall be subject to the publication policies set forth in Exhibit G to the MCTA, including the right of the Sponsor and the Network to coordinate the timing and content of multi-site Publications.
ARTICLE 9 — SAFETY REPORTING
Section 9.1 — SAE Reporting. The Site shall report all serious adverse events ("SAEs") occurring in Study subjects enrolled at the Site to the Sponsor and to the CRO (Meridian Contract Research Organization, Inc.) within twenty-four (24) hours of the Site's awareness of the event. For purposes of this Agreement, a "serious adverse event" is 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, results in a congenital anomaly or birth defect, or is a medically important event that may jeopardize the subject or may require medical or surgical intervention to prevent one of the outcomes listed above, consistent with the definitions set forth in 21 C.F.R. § 312.32 and ICH E2A. The procedures for SAE reporting, including the required reporting forms, electronic submission methods, follow-up reporting timelines, and the distribution of SAE reports to the Veridian Central IRB, are set forth in detail in Exhibit J to the MCTA and shall be followed by the Site in all respects.
Section 9.2 — IND Safety Reports. The Sponsor, as the holder of IND 157823 for penterafenib, is solely responsible for the preparation, submission, and distribution of IND safety reports to the FDA in accordance with 21 C.F.R. § 312.32, including: (a) telephone or facsimile reports to the FDA within seven (7) calendar days of initial receipt of information for any adverse event that is both serious and unexpected and results in death or is life-threatening (a "7-day report"); and (b) written reports to the FDA within fifteen (15) calendar days of initial receipt of information for all other adverse events that are both serious and unexpected and are associated with the use of the Investigational Product (a "15-day report"). The Sponsor shall distribute copies of all IND safety reports to the Site Principal Investigator and to the Veridian Central IRB in accordance with the timelines and procedures set forth in Exhibit J to the MCTA.
Section 9.3 — Coordination with CRO. All safety data management activities, including the receipt, processing, coding, assessment, and reporting of adverse events and SAEs, shall be coordinated by and through Meridian Contract Research Organization, Inc., acting on behalf of the Sponsor, in accordance with the safety reporting procedures set forth in Exhibit J to the MCTA and the pharmacovigilance agreement between the Sponsor and the CRO. The Site shall direct all initial SAE reports and follow-up reports to the CRO's pharmacovigilance department using the contact information and submission methods specified in Exhibit J. The CRO shall serve as the Sponsor's agent for purposes of receiving, processing, and transmitting safety information, and the Site may rely on written instructions from the CRO regarding safety reporting procedures to the same extent as if such instructions were provided directly by the Sponsor.
ARTICLE 10 — REGULATORY COMPLIANCE REPRESENTATIONS AND COVENANTS
Section 10.1 — Regulatory Compliance. The Site represents and warrants that it is, and covenants that it shall remain throughout the term of this Agreement, in compliance with all applicable federal, state, and local laws, rules, and regulations governing the conduct of clinical trials and the use of investigational products, including without limitation:
(a) The Federal Food, Drug, and Cosmetic Act, as amended, and the regulations of the FDA promulgated thereunder, including 21 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 Guideline for Good Clinical Practice, ICH E6(R2);
(c) The Federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b) and all applicable safe harbor regulations;
(d) The Physician Payments Sunshine Act (Section 6002 of the Patient Protection and Affordable Care Act), including the accurate and timely reporting of all payments and transfers of value to covered recipients;
(e) The Health Insurance Portability and Accountability Act of 1996, as amended, and its implementing regulations at 45 C.F.R. Parts 160 and 164;
(f) The Common Rule for the Protection of Human Subjects (45 C.F.R. Part 46), to the extent applicable; and
(g) All applicable Colorado state laws and regulations governing the conduct of clinical research, the protection of human subjects, and the use of investigational drugs.
Section 10.2 — Financial Disclosure. The Site Principal Investigator and all sub-investigators listed on the FDA Form 1572 shall complete and submit to the Sponsor Financial Disclosure Certifications in accordance with 21 C.F.R. Part 54, disclosing all financial interests, significant payments, equity interests, and proprietary interests (as those terms are defined in 21 C.F.R. § 54.2) held by the investigator, the investigator's spouse, and each dependent child. Such certifications shall be submitted prior to Site activation and shall be promptly updated upon any material change in the disclosed financial interests during the course of the Study and for a period of one (1) year following the completion of the Study. The Site shall cooperate with the Sponsor in the collection, review, and submission of financial disclosure information as required by the FDA.
Section 10.3 — Debarment and Exclusion. The Site represents and warrants that neither Cedar Falls University Hospital nor any of its officers, directors, employees, investigators, sub-investigators, or site staff members who will be involved in the conduct of the Study is currently, or has ever been: (a) debarred, suspended, proposed for debarment, or otherwise ineligible to participate in Federal procurement or non-procurement programs under the Generic Drug Enforcement Act of 1992 (21 U.S.C. § 335a) or any other applicable federal law; (b) excluded, suspended, or otherwise ineligible to participate in any Federal healthcare program (including Medicare and Medicaid) as listed on the U.S. Department of Health and Human Services, Office of Inspector General List of Excluded Individuals/Entities (LEIE) or the General Services Administration System for Award Management (SAM) exclusion list; or (c) the subject of any pending or threatened investigation or proceeding that could result in any such debarment or exclusion. The Site shall promptly notify the Sponsor in writing if any such debarment, exclusion, or disqualification occurs or is threatened during the term of this Agreement.
ARTICLE 11 — TERM, TERMINATION, AND WIND-DOWN
Section 11.1 — Term. This Individual Site Agreement shall become effective upon the later of (a) the date on which this Agreement is fully executed by all Parties (the "Execution Date") or (b) the Effective Date of the MCTA (July 18, 2023), and shall remain in effect until the earlier of: (i) the completion of all Study activities at the Site, including the collection and entry of all data, resolution of all data queries, return or destruction of all unused Investigational Product, and completion of all close-out activities; or (ii) the termination of this Agreement in accordance with the provisions of this Article 11 (the "Term").
Section 11.2 — Termination. This Individual Site Agreement may be terminated under the following circumstances:
(a) Termination by the Sponsor: The Sponsor may terminate this Agreement, with or without cause, upon ninety (90) days' prior written notice to the Site and the Network. In the event of termination by the Sponsor, the wind-down provisions of Section 11.2(d) shall apply.
(b) Termination by the Site: The Site may terminate this Agreement upon ninety (90) days' prior written notice to the Sponsor and the Network, provided that the Site shall comply with the wind-down provisions of Section 11.2(d) and shall ensure the safety and continuity of care of all subjects enrolled at the Site.
(c) Termination for Cause: Either Party may terminate this Agreement immediately upon written notice in the event of a material breach by the other Party that remains uncured for a period of thirty (30) days following written notice specifying the nature of the breach, or immediately in the event of a breach that is not susceptible to cure (including, without limitation, fraud, scientific misconduct, debarment or exclusion of the Site or any investigator, or a determination by the FDA or the IRB that the Study at the Site must be suspended or terminated).
(d) Wind-Down Period: In the event of any termination under this Section 11.2, the Site shall have a wind-down period of one hundred twenty (120) calendar days from the effective date of termination to ensure the safety and continuity of care of all Study subjects. During the wind-down period, the Site shall: (i) continue to provide medical care to all subjects in active treatment at the Site; (ii) transition subjects to alternative care or, with the Sponsor's written approval, permit subjects to complete their current treatment cycle; (iii) complete all required safety follow-up assessments; (iv) enter all outstanding data into the EDC Platform; (v) return or account for all unused Investigational Product; and (vi) cooperate with the CRO in the completion of close-out monitoring activities.
Section 11.3 — Effect of Termination. The expiration or termination of this Agreement shall not relieve any Party of any obligations that have accrued prior to the effective date of such expiration or termination, including without limitation: (a) indemnification obligations under Article 5; (b) confidentiality obligations under Article 7; (c) data ownership rights under Article 8; (d) record retention requirements under Section 8.2; (e) payment obligations for services rendered and milestones achieved prior to termination; (f) insurance obligations under Article 6 (to the extent of the required post-termination tail coverage period); and (g) obligations to cooperate with regulatory authorities in connection with inspections, audits, or inquiries relating to the Study. The provisions of Articles 5, 7, 8, 10, and 12, and Sections 8.2, 11.3, and 14.1 through 14.6, shall survive the expiration or termination of this Agreement.
ARTICLE 12 — DISPUTE RESOLUTION
Section 12.1 — Governing Law. This Individual Site Agreement and the MCTA shall be governed by and construed in accordance with the laws of the State of New York, without regard to its conflict of laws principles. The Parties agree that the United Nations Convention on Contracts for the International Sale of Goods shall not apply to this Agreement.
Section 12.2 — Escalation Procedure. Any dispute, controversy, or claim arising out of or relating to this Agreement, the MCTA, or the breach, termination, or validity thereof (a "Dispute") shall be resolved in accordance with the following escalation procedure:
(a) Negotiation. The Parties shall first attempt to resolve the Dispute through good-faith negotiations between designated senior representatives of each Party. Within ten (10) business days of written notice of a Dispute, each Party shall designate a senior representative with authority to negotiate a resolution, and such representatives shall meet (in person or by videoconference) and negotiate in good faith for a period of thirty (30) calendar days (the "Negotiation Period").
(b) Mediation. If the Dispute is not resolved during the Negotiation Period, either Party may submit the Dispute to mediation administered by the American Arbitration Association ("AAA") under its Commercial Mediation Procedures. The mediation shall be conducted in New York, New York, by a single mediator selected in accordance with the AAA Commercial Mediation Procedures. The Parties shall participate in the mediation in good faith for a period of sixty (60) calendar days from the appointment of the mediator (the "Mediation Period"). The costs of mediation shall be shared equally by the Parties.
(c) Binding Arbitration. If the Dispute is not resolved during the Mediation Period, either Party may submit the Dispute to final and binding arbitration administered by the AAA under its Commercial Arbitration Rules. The arbitration shall be conducted in New York, New York, before a panel of three (3) arbitrators selected in accordance with the AAA Commercial Arbitration Rules. The arbitrators shall have experience in pharmaceutical and clinical trial matters. The arbitral award shall be final and binding on the Parties and may be entered and enforced in any court of competent jurisdiction. The costs of arbitration shall be allocated by the arbitral panel in accordance with the AAA Commercial Arbitration Rules.
Section 12.3 — Injunctive Relief. Notwithstanding the foregoing, either Party may seek injunctive or other equitable relief from the state and federal courts located in the County of New York, State of New York, to prevent irreparable harm pending the outcome of the dispute resolution procedures set forth in this Article 12. Each Party hereby consents to the exclusive jurisdiction and venue of such courts for purposes of injunctive or equitable relief and waives any objection to such jurisdiction or venue on the grounds of inconvenient forum or otherwise.
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