EXHIBIT K
Approved Subcontractors and Third-Party Service Providers
Attached to and forming part of the Master Clinical Trial Agreement dated June 28, 2023 (the "Agreement")
Parties to the Agreement:
Sponsor: 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.
Site Network: Veridian Health Research Network, Inc. ("Site Network"), a corporation organized and existing under the laws of the State of Delaware as a 501(c)(3) nonprofit organization, with its principal offices located at 750 Research Parkway, 8th Floor, Philadelphia, Pennsylvania 19104.
Protocol: PPC-4871-III — CLARION (Clinical Assessment of Response with Longitudinal Investigation in ONcology)
Investigational Product: Penterafenib (PPC-4871)
IND Number: IND 157823
ClinicalTrials.gov Identifier: NCT05928174
Section 1 — Purpose and Scope
This Exhibit K identifies the approved subcontractors and third-party service providers (each, an "Approved Subcontractor" and collectively, the "Approved Subcontractors") authorized by Sponsor to perform services in connection with Protocol PPC-4871-III (the "Study") pursuant to Section 8.2 of the Agreement. The Approved Subcontractors listed herein have been vetted and selected by Sponsor in its sole discretion and are engaged by Sponsor to support the efficient, high-quality, and regulatory-compliant conduct of the Study across all Participating Sites within the Site Network.
Capitalized terms used but not defined in this Exhibit K shall have the meanings ascribed to them in the Agreement, including its other Exhibits and Schedules. In the event of any conflict between the provisions of this Exhibit K and the body of the Agreement, the terms of the Agreement shall control, except to the extent that this Exhibit K provides more specific detail regarding the identity, scope of services, or operational responsibilities of the Approved Subcontractors.
Each Approved Subcontractor listed herein has been engaged by Sponsor under a separate written agreement that imposes obligations of confidentiality, regulatory compliance, data protection, and quality assurance consistent with the terms of the Agreement. Sponsor represents and warrants that each such separate written agreement contains provisions requiring the Approved Subcontractor to perform its services in accordance with all Applicable Laws, including but not limited to the Federal Food, Drug, and Cosmetic Act, the regulations promulgated by the United States Food and Drug Administration ("FDA"), the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ("ICH") guidelines, and the Health Insurance Portability and Accountability Act of 1996, as amended ("HIPAA"), to the extent applicable.
The Site Network and each Participating Site, including each principal investigator, sub-investigator, study coordinator, and other authorized site personnel, shall cooperate with the Approved Subcontractors listed herein as reasonably necessary for the proper and timely conduct of the Study. Such cooperation shall include, without limitation, providing access to Study records, Study subjects (in accordance with applicable informed consent requirements and privacy protections), and Participating Site facilities during normal business hours and at such other times as may be reasonably agreed upon by the parties, granting system access credentials as required for electronic data capture and monitoring activities, and responding to data queries and requests for information within the timelines set forth in the Protocol, the Monitoring Plan, and the Agreement.
No additional subcontractors or third-party service providers shall be engaged by Sponsor for services that directly affect the operations, obligations, or personnel of the Participating Sites without prior written notice to the Site Network, in accordance with Section 8.3 of the Agreement. For the avoidance of doubt, Sponsor retains the right to engage subcontractors for internal functions that do not involve direct interaction with, or impose obligations upon, the Participating Sites or the Site Network without providing such prior notice; provided, however, that any such engagement shall not relieve Sponsor of its obligations under the Agreement.
Section 2 — Approved Subcontractors List
The following entities have been approved by Sponsor as Approved Subcontractors for the conduct of the Study. The scope of services, governing agreements, key site-facing activities, and regulatory compliance information for each Approved Subcontractor are set forth below.
2.1 — Contract Research Organization (CRO)
Scope of Services. Meridian CRO has been engaged by Sponsor to serve as the primary contract research organization for the Study. The scope of services delegated to Meridian CRO includes, but is not limited to, the following:
(a) Clinical Trial Monitoring. Meridian CRO shall perform all on-site and remote monitoring activities at each Participating Site in accordance with the Study Monitoring Plan, the Protocol, and ICH E6(R2) GCP Guidelines. Monitoring activities shall include source data verification, review of regulatory documents, assessment of investigational product accountability, and evaluation of overall site compliance with the Protocol and Applicable Laws.
(b) Clinical Data Management. Meridian CRO shall provide clinical data management services, including data review, query generation and resolution, medical coding (using MedDRA and WHO Drug Dictionary), data reconciliation, and database lock activities, in coordination with the EDC platform vendor identified in Section 2.2 below.
(c) Safety Reporting and Pharmacovigilance Support. Meridian CRO shall support Sponsor's pharmacovigilance and safety reporting obligations, including the receipt, processing, evaluation, and regulatory reporting of adverse events, serious adverse events, and suspected unexpected serious adverse reactions in accordance with 21 C.F.R. § 312.32 and ICH E2A guidelines.
(d) Biostatistical Analysis. Meridian CRO shall perform all biostatistical analyses for the Study, including generation of the Statistical Analysis Plan (SAP), interim analyses (if applicable), and the final integrated clinical and statistical report.
(e) Regulatory Document Management Support. Meridian CRO shall support Sponsor in maintaining the Trial Master File (TMF), including collection, review, quality control, and archiving of essential documents in accordance with ICH E6(R2) Section 8 and 21 C.F.R. Part 312.
Governing Agreement. The services to be provided by Meridian CRO are governed by the Master Services Agreement between Penterra Pharmaceuticals Corp. and Meridian Contract Research Organization, Inc. dated January 15, 2023, together with all applicable work orders, task orders, and amendments thereto (collectively, the "Meridian MSA"). The Meridian MSA contains provisions requiring Meridian CRO to comply with all Applicable Laws, maintain adequate insurance coverage, protect Confidential Information, and submit to audit by Sponsor and regulatory authorities.
Key Site-Facing Activities. In the course of performing its services, Meridian CRO will interact directly with the Site Network and each Participating Site in the following capacities:
(i) Site Visits. Meridian CRO shall conduct site initiation visits ("SIVs"), interim monitoring visits ("IMVs"), and close-out visits ("COVs") at each Participating Site in accordance with the Study Monitoring Plan. The frequency and duration of IMVs shall be determined based on enrollment rates, data quality metrics, and risk-based monitoring assessments, but shall occur no less frequently than every six (6) weeks during active enrollment and every eight (8) weeks during the follow-up period, unless otherwise agreed in writing by Sponsor and the Site Network.
(ii) eCRF Data Collection and Query Resolution. Meridian CRO clinical data managers shall review electronic case report form ("eCRF") data entered by site personnel and issue data queries as needed. Participating Sites shall use commercially reasonable efforts to respond to data queries within seven (7) calendar days of issuance.
(iii) Serious Adverse Event Reporting. Meridian CRO shall serve as the primary point of receipt for serious adverse event ("SAE") reports submitted by Participating Sites. Each Participating Site shall report all SAEs to Meridian CRO within twenty-four (24) hours of the investigator's awareness of the event, using the SAE reporting form and procedures provided by Meridian CRO during site initiation training. Meridian CRO shall, in turn, ensure timely onward reporting to Sponsor and, where applicable, to the FDA.
(iv) IND Safety Reports. Meridian CRO shall coordinate the preparation and distribution of IND safety reports to all participating investigators in accordance with 21 C.F.R. § 312.32, including seven (7)-calendar-day telephone or facsimile reports for fatal or life-threatening suspected adverse reactions and fifteen (15)-calendar-day written reports for all other reportable safety events.
Contact for Site Network Coordination. The specific operational contact person(s) at Meridian CRO responsible for day-to-day coordination with the Site Network and each Participating Site shall be identified by Sponsor and communicated in writing to the Site Network promptly following execution of the Agreement and prior to commencement of site initiation activities.
2.2 — Electronic Data Capture (EDC) Platform Vendor
Scope of Services. Pinnacle has been engaged by Sponsor to provide the electronic clinical data capture platform and related technology services for the Study. The scope of services includes, but is not limited to, the following:
(a) EDC Platform Provision and Maintenance. Pinnacle shall provide and maintain the eClinical / electronic data capture ("EDC") platform to be used for Study data capture across all thirty-eight (38) Participating Sites. The EDC platform shall be configured to capture all data fields specified in the Protocol and the eCRF Completion Guidelines, and shall be available to authorized users on a twenty-four (24) hours per day, seven (7) days per week basis, subject to scheduled maintenance windows communicated to site users with no less than seventy-two (72) hours' advance notice.
(b) System Configuration, Validation, and Deployment. Pinnacle shall configure the EDC platform specifically for Protocol PPC-4871-III, including the design and programming of eCRF pages, edit checks, derivations, and validation rules. System validation shall be conducted in accordance with a prospective validation plan and documented through installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) protocols.
(c) User Account Provisioning and Technical Support. Pinnacle shall provision individual user accounts for authorized site personnel, including principal investigators, sub-investigators, study coordinators, and data entry personnel. User access shall be role-based, with access privileges assigned in accordance with the access control matrix approved by Sponsor. Pinnacle shall provide ongoing technical support via a dedicated help desk.
(d) 21 C.F.R. Part 11 Compliance. The EDC platform shall maintain full compliance with 21 C.F.R. Part 11 requirements for electronic records and electronic signatures, including audit trail functionality, user authentication, data integrity controls, and system security measures. All electronic signatures applied within the platform shall be the legally binding equivalent of handwritten signatures in accordance with 21 C.F.R. § 11.100.
(e) System Hosting, Data Backup, and Disaster Recovery. Pinnacle shall host the EDC platform in validated, secure data center facilities. Data backup procedures shall be performed no less frequently than daily, with backups stored at a geographically separate disaster recovery site. Pinnacle shall maintain a documented disaster recovery plan with a recovery time objective (RTO) of no more than four (4) hours and a recovery point objective (RPO) of no more than one (1) hour.
Technology / EDC Integration Costs under the Agreement. The total fixed cost for EDC platform services provided by Pinnacle in connection with the Study is One Million Two Hundred Thirty Thousand Dollars ($1,230,000.00), as set forth in Exhibit B (Budget and Payment Terms) of the Agreement. This fixed cost encompasses system configuration, validation, deployment, hosting, maintenance, technical support, and user training for the duration of the Study.
Governing Agreement. The services to be provided by Pinnacle are governed by a separate vendor agreement between Penterra Pharmaceuticals Corp. and Pinnacle Data Solutions, Inc. (the "Pinnacle Agreement"). The Pinnacle Agreement includes provisions regarding system performance standards, data security, confidentiality, intellectual property, indemnification, and regulatory compliance.
Key Site-Facing Activities. In the course of performing its services, Pinnacle will interact directly with the Site Network and each Participating Site in the following capacities:
(i) Site-Level EDC Training and Certification. Pinnacle shall develop and deliver EDC training to authorized site personnel at each Participating Site prior to the entry of any Study data into the platform. Training shall cover system navigation, eCRF completion, electronic signature procedures, and query management. All site personnel must complete training and demonstrate competency before being granted access to enter or modify Study data. Evidence of training completion and certification shall be maintained in the TMF.
(ii) Ongoing Technical Help Desk Support. Pinnacle shall provide ongoing technical help desk support for site users during business hours (Monday through Friday, 8:00 AM to 8:00 PM Eastern Time), with after-hours emergency support available via a dedicated telephone line and email. Target response times for help desk inquiries shall be no more than two (2) business hours for priority issues (e.g., system access failures, data entry errors affecting patient safety) and no more than one (1) business day for standard inquiries.
(iii) Data Export and Reporting Tools. Pinnacle shall make data export and reporting tools available to authorized site personnel, enabling principal investigators and study coordinators to view, export, and report on data entered at their respective Participating Sites. Access to cross-site aggregate data shall be restricted to Sponsor and Meridian CRO personnel unless otherwise authorized in writing by Sponsor.
Regulatory Compliance. The EDC platform provided by Pinnacle has been validated in compliance with 21 C.F.R. Part 11 (Electronic Records; Electronic Signatures) and the ICH E6(R2) Guideline for Good Clinical Practice, including the requirements pertaining to computerized systems (Section 5.5.3). Pinnacle maintains SOC 2 Type II certification for its data center operations and undergoes annual independent audits of its information security management systems.
Contact for Site Network Coordination. The specific operational contact person(s) at Pinnacle responsible for coordination with the Site Network and each Participating Site shall be identified by Sponsor and communicated in writing to the Site Network promptly following execution of the Agreement and prior to commencement of site initiation activities.
2.3 — Central Laboratory
Scope of Services. Northbridge has been engaged by Sponsor to serve as the central laboratory for the Study, providing laboratory testing, bioanalytical, and specimen management services. The scope of services includes, but is not limited to, the following:
(a) Pharmacokinetic (PK) and Pharmacodynamic (PD) Analyses. Northbridge shall perform all protocol-specified pharmacokinetic and pharmacodynamic analyses for Study subjects, including but not limited to plasma concentration measurements of penterafenib and its active metabolites, using validated bioanalytical methods (LC-MS/MS or equivalent).
(b) Biomarker Assay Development and Analysis. Northbridge shall develop, validate, and perform biomarker assays as specified in the Protocol, including but not limited to the evaluation of predictive and prognostic biomarkers related to the mechanism of action of penterafenib. Assay validation documentation shall be provided to Sponsor upon request.
(c) Safety Laboratory Analyses. Northbridge shall perform centralized safety laboratory analyses for the Study, including hematology (complete blood count with differential), clinical chemistry (comprehensive metabolic panel, hepatic function panel, lipid panel, and other protocol-specified analytes), urinalysis, coagulation studies, and any additional laboratory assessments specified in the Protocol or required by the Data Safety Monitoring Board (DSMB).
(d) Sample Receipt, Processing, Storage, and Chain-of-Custody Management. Northbridge shall receive, accession, process, and store biological specimens collected from Study subjects at each Participating Site. Northbridge shall maintain a documented chain-of-custody process for all specimens from receipt through analysis and long-term storage. Specimens designated for future exploratory research shall be stored in accordance with the biobanking provisions of the Protocol and the informed consent document.
(e) Laboratory Kit Preparation and Distribution. Northbridge shall prepare and distribute laboratory kits to each Participating Site, including collection tubes, requisition forms, specimen labels, temperature monitoring devices, absorbent packaging materials, biohazard bags, and pre-addressed shipping containers. Kit replenishment shall be performed on a scheduled basis and upon request by Participating Sites.
(f) Results Reporting. Northbridge shall report laboratory results to the EDC platform (Pinnacle) via validated electronic data transfer. Results shall also be made available to Meridian CRO for safety review and data management purposes. Critical or panic-value results shall be communicated directly to the responsible investigator at the applicable Participating Site within two (2) hours of result confirmation, in accordance with the Laboratory Manual.
Governing Agreement. The services to be provided by Northbridge are governed by a separate central laboratory services agreement between Penterra Pharmaceuticals Corp. and Northbridge Bioanalytical Laboratories, Inc. (the "Northbridge Agreement"). The Northbridge Agreement includes provisions regarding laboratory performance standards, quality assurance, confidentiality, sample retention and destruction, indemnification, and regulatory compliance.
Key Site-Facing Activities. In the course of performing its services, Northbridge will interact directly with the Site Network and each Participating Site in the following capacities:
(i) Laboratory Kit Provision and Shipping Materials. Northbridge shall supply each Participating Site with complete laboratory kits, requisition forms, and shipping materials necessary for the collection and transport of biological specimens. Kits shall be shipped to Participating Sites at least two (2) weeks prior to each site's anticipated date of first subject enrollment and shall be replenished as needed to ensure an adequate supply throughout the enrollment and treatment periods.
(ii) Site Personnel Training. Northbridge shall provide training to site personnel on specimen collection, processing, labeling, packaging, and shipment procedures, including compliance with applicable Department of Transportation (DOT) and International Air Transport Association (IATA) regulations governing the transport of biological substances. Training may be delivered in person during the site initiation visit, via live webinar, or through Northbridge's online training portal, and shall be documented in the TMF.
(iii) Laboratory Reference Ranges and Safety Alerts. Northbridge shall issue standardized laboratory reference ranges applicable to all Participating Sites, ensuring consistency of result interpretation across the Study. Northbridge shall also implement an automated alerting system for out-of-range safety values, including critical/panic values, which shall be communicated to the responsible investigator at each Participating Site within the timelines specified in the Laboratory Manual.
Regulatory Compliance. Northbridge operates in compliance with the Clinical Laboratory Improvement Amendments of 1988 ("CLIA") and holds current CLIA certification (Certificate of Accreditation). Northbridge is accredited by the College of American Pathologists ("CAP") and undergoes biennial inspection. Northbridge further operates in compliance with ICH E6(R2) GCP Guidelines and all applicable FDA regulations, including 21 C.F.R. Part 58 (Good Laboratory Practice for Nonclinical Laboratory Studies) to the extent applicable to bioanalytical method validations.
Contact for Site Network Coordination. The specific operational contact person(s) at Northbridge responsible for coordination with the Site Network and each Participating Site shall be identified by Sponsor and communicated in writing to the Site Network promptly following execution of the Agreement and prior to commencement of site initiation activities.
Section 3 — Data Protection and Confidentiality
Each Approved Subcontractor identified in Section 2 of this Exhibit K is bound by written confidentiality obligations under its respective governing agreement with Sponsor. Such confidentiality obligations are consistent with the terms set forth in Exhibit F (Confidentiality Provisions) of the Agreement, including a confidentiality term of ten (10) years from the date of disclosure of Confidential Information. Confidential Information of the Site Network and each Participating Site that may be disclosed to or accessed by an Approved Subcontractor in the course of performing its services shall be treated as Confidential Information under the applicable governing agreement and shall be subject to the same protections.
Each Approved Subcontractor is subject to data protection obligations under its respective governing agreement with Sponsor, including compliance with HIPAA (45 C.F.R. Parts 160 and 164) to the extent applicable to the services performed by such Approved Subcontractor. Where an Approved Subcontractor creates, receives, maintains, or transmits protected health information ("PHI") on behalf of Sponsor or a Participating Site, an appropriate business associate agreement compliant with the requirements of 45 C.F.R. § 164.504(e) is in place between the applicable parties. Where an Approved Subcontractor processes personal data subject to other applicable data protection laws, including but not limited to state privacy laws, an appropriate data processing agreement is in place.
All Study data collected, processed, stored, or managed by Approved Subcontractors in connection with the Study remains the exclusive property of Sponsor (Penterra Pharmaceuticals Corp.) as set forth in Exhibit G (Data Ownership and intellectual Property) of the Agreement. No Approved Subcontractor shall acquire any ownership interest in Study data by virtue of its collection, processing, or management of such data. Each Approved Subcontractor is contractually obligated to return or destroy Study data upon completion or termination of its services, subject to applicable regulatory retention requirements.
Approved Subcontractors shall not disclose Confidential Information of the Site Network or any Participating Site to any third party except as strictly required for the performance of their respective services under their governing agreements with Sponsor, as required by applicable law or regulation, or as required by a regulatory authority having jurisdiction over the Study. In the event that an Approved Subcontractor receives a legal or regulatory demand for the disclosure of Confidential Information of the Site Network or a Participating Site, such Approved Subcontractor shall, to the extent permitted by law, provide prompt written notice to Sponsor, and Sponsor shall promptly notify the Site Network, to afford the Site Network a reasonable opportunity to seek a protective order or other appropriate remedy.
Section 4 — Regulatory Compliance Obligations
Each Approved Subcontractor identified in Section 2 of this Exhibit K shall perform its respective services in connection with the Study in compliance with all Applicable Laws, including without limitation the following:
(a) 21 C.F.R. Part 11 — Electronic Records; Electronic Signatures;
(b) 21 C.F.R. Part 50 — Protection of Human Subjects (Informed Consent);
(c) 21 C.F.R. Part 54 — Financial Disclosure by Clinical Investigators;
(d) 21 C.F.R. Part 56 — Institutional Review Boards;
(e) 21 C.F.R. Part 312 — Investigational New Drug Application;
(f) ICH E6(R2) Guideline for Good Clinical Practice;
(g) HIPAA (45 C.F.R. Parts 160 and 164), to the extent applicable to the services performed by the Approved Subcontractor; and
(h) All other applicable federal, state, and local laws, regulations, and guidance documents, including but not limited to applicable state clinical trial registration and reporting requirements, state data breach notification laws, and FDA guidance documents relating to the oversight of clinical investigations.
Sponsor shall be responsible for the oversight and management of all Approved Subcontractors in accordance with ICH E6(R2) Section 5.2 (Delegation of Sponsor Duties) and shall ensure that the delegation and performance of subcontracted services does not diminish the quality, integrity, or regulatory compliance of the Study. Sponsor's oversight responsibilities include, without limitation, the prospective evaluation of each Approved Subcontractor's qualifications and capability, the establishment of written agreements specifying the duties and responsibilities of each Approved Subcontractor, and the ongoing monitoring of each Approved Subcontractor's performance.
Each Approved Subcontractor is subject to audit by Sponsor, by the Site Network (to the extent provided in the Agreement), and by applicable regulatory authorities, including the FDA, at any time during the term of the Study and for the period thereafter during which records are required to be maintained. Records pertaining to the Study that are created, received, or maintained by Approved Subcontractors shall be retained for a minimum of fifteen (15) years following Study completion, consistent with Section 12.4 of the Agreement, or for such longer period as may be required by Applicable Laws or regulatory authority directive. Approved Subcontractors shall make such records available for inspection and copying by Sponsor, the Site Network (as applicable), and regulatory authorities upon reasonable notice.
Section 5 — Modifications to Approved Subcontractors List
Sponsor may, in its discretion, add new Approved Subcontractors to, remove existing Approved Subcontractors from, or replace Approved Subcontractors on this Exhibit K upon written notice to the Site Network. Any replacement Approved Subcontractor shall meet qualifications equivalent to, or exceeding, those of the Approved Subcontractor being replaced and shall assume obligations consistent with those set forth in this Exhibit K and the Agreement. Written notice of the addition, removal, or replacement of an Approved Subcontractor shall be provided to the Site Network no less than thirty (30) calendar days prior to the effective date of such change, except in cases of emergency or urgent regulatory necessity, in which case notice shall be provided as soon as reasonably practicable.
In the event of a material change in the scope of services provided by an Approved Subcontractor that directly affects the operations, workflows, or obligations of one or more Participating Sites — including but not limited to changes to monitoring visit frequency, EDC platform functionality, laboratory kit specifications, or specimen handling procedures — Sponsor shall consult with the Site Network prior to implementation of such change. Such consultation shall be conducted in good faith and shall afford the Site Network a reasonable opportunity to evaluate the potential impact of the proposed change on Participating Site operations and to provide input to Sponsor regarding the proposed implementation plan and timeline.
Any updated version of this Exhibit K resulting from the addition, removal, or replacement of an Approved Subcontractor, or from a material change in the scope of services, shall be prepared by Sponsor and provided to the Site Network in writing. The updated Exhibit K shall be deemed effective upon written acknowledgment by both Sponsor and the Site Network, which acknowledgment shall not be unreasonably withheld, conditioned, or delayed. The most recent version of Exhibit K acknowledged by both parties shall supersede all prior versions and shall be deemed incorporated into the Agreement by reference.
Section 6 — Contact Information
Specific operational contact persons for each Approved Subcontractor, including designated clinical research associates (CRAs), EDC help desk representatives, and laboratory coordinators, will be provided by Sponsor to the Site Network and to each Participating Site's principal investigator and primary study coordinator promptly following execution of the Agreement and prior to the commencement of site initiation activities. Contact information shall be maintained in a centralized Study contact directory, which shall be updated by Sponsor and distributed to the Site Network on a periodic basis throughout the duration of the Study.
General inquiries regarding the Approved Subcontractors listed in this Exhibit K, including questions regarding scope of services, coordination of site-facing activities, and escalation of issues, may be directed to the following individuals:
Sponsor Contact:
Jennifer Holt Vice President, Clinical Operations Penterra Pharmaceuticals Corp. 200 Biopharma Boulevard, Suite 1400 Princeton, New Jersey 08540
Site Network Contact:
Diane Prescott Chief Operating Officer Veridian Health Research Network, Inc. 750 Research Parkway, 8th Floor Philadelphia, Pennsylvania 19104
Acknowledgment
This Exhibit K is incorporated by reference into the Agreement and does not require separate execution by the parties. The Agreement, including this Exhibit K and all other Exhibits and Schedules attached thereto, was duly executed on June 28, 2023, by the authorized representatives of the parties identified below:
PENTERRA PHARMACEUTICALS CORP.
By: ________
Name: Nathaniel Briggs
Title: Vice President & General Counsel
Date: June 28, 2023
VERIDIAN HEALTH RESEARCH NETWORK, INC.
By: ________
Name: Dr. Franklin Osei
Title: President & Chief Executive Officer
Date: June 28, 2023
CONFIDENTIAL — This Exhibit K and its contents constitute Confidential Information under the Agreement and are subject to the confidentiality provisions set forth in Exhibit F of the Agreement. Unauthorized disclosure, reproduction, or distribution is strictly prohibited.
| Field | Detail |
| Entity Name | Meridian Contract Research Organization, Inc. ("Meridian CRO") |
| Entity Type | Corporation organized under the laws of the State of Delaware |
| Headquarters Address | 9200 Corporate Boulevard, Raleigh, North Carolina 27615 |
| Chief Executive Officer | Thomas Hartwell |
| Field | Detail |
| Entity Name | Pinnacle Data Solutions, Inc. ("Pinnacle") |
| Entity Type | Corporation organized under the laws of the State of Delaware |
| Headquarters Address | 6000 Clearwater Drive, San Diego, California 92121 |
| Field | Detail |
| Entity Name | Northbridge Bioanalytical Laboratories, Inc. ("Northbridge") |
| Entity Type | Corporation organized under the laws of the State of Maryland |
| Headquarters Address | 2900 Commerce Way, Baltimore, Maryland 21224 |