**/**/****

*

CURRICULUM VITAE

NAME: Lauri A. Pixley, ACRP-PM, CCRA

OFFICE ADDRESS: Pixley Scientific, Inc

*** ****** ******, #*****

Green Cove Springs, FL 32043

ad1f3v@r.postjobfree.com

512-***-****

(CM&F - Professional Liability Insured)

EDUCATION: BA Biology, University of Texas, Austin, Texas – 1993 CERTIFICATION: ACRP-PM Certification since - 27Sep2018 (status – current) ACRP-CCRA Certification since - Nov 1997 (26 yrs; status – current) THERAPEUTIC AREA EXPERIENCE AND SKILLS

Monitored phase 1-IVB studies: 97 Trials (9 In-Patient trials not including Phase I) First Time in Man Studies - 8

Phase I – 27 (includes first time man studies & Phase I/II combinations & I-B) Phase II – 18 (includes Phase I/IIA & B/III combinations) Phase III – 54 (includes Phase II/IV & B combinations) Phase IV - 4

• EDC / Computer System Database experience includes: Outlook / Mimecast / Webmail (Email) / VOIP (phone) / Webex Sites (Cisco, etc) CTMS: Axiom-Fusion / TrialWorks / ICOTRIAL / Citrix / Siebel (Oracle) LMS / LearningLink: Training Databases (Study-Related Training, SOPs, GCPs, etc…) Bracket / United Biosource (IXRS)

Deltek / SPSOrion / SMS (Kronos)

Axiom: (1 protocol – 5 sites)

DataLabs: (8 protocols – 14 sites)

Datatrak: (2 protocols – 2 sites)

IBM (Zelta): (1 protocol – 2 sites)

Oracle: (1 protocol – 9 sites)

Medrio: (1 protocol – 1 site)

InForm: (4 protocols – 21 sites)

RAVE/Medidata: (7 protocols – 22 sites)

Velos: (2 protocols – 3 sites)

DFExplore: (1 protocol – 3 sites)

Vendor Websites: Cardiocore / ICON & Quintiles Labs / Quorum IRB / World Travel / SharePoint / ICON Portals / PPD Portals / PRA Portals / Octapharma Portals

• Therapeutic experience includes:

o Cardiovascular – All-Cause Vascular Events, CAD, CHF (stem-cell transplant), CLI

(stem-cell transplant), Heart Failure, Hypertension, myocardial infarction, Strokes, PAD

(stem-cell transplant), Coagulation Factor Replacement, Cardiac Surgery Prothrombin o Central Nervous System/Neurology – Pain, Partial Seizures o Central Nervous System/Psychiatry – Acute Mania, ADHD, Depression ( MDD Adult & Adolescent), Schizophrenia, Schizoaffective Disorder, Alzheimer’s, Parkinson’s o Dermatology – Alopecia, Atopic Dermatitis, Herpes Labialis, Dermatomyositis o Endocrinology / Metabolic – Anti-Inflammatories, Diabetes, Diabetic Foot Infections, Edema, End Stage Renal Disease, GERD, Gout, Hypercholesterolemia, Hyperprolactinemia, Pancreatic Cholesterol Esterace Inhibitor, Rheumatoid Arthritis, Ulcerative Colitis, Urinary Incontinence

o Infectious Disease – Antibiotics, Antifungals (Septicemia: Oncology/Hematology - Candidemia, Aspergillus, Adenovirus), Antiviral (HIV, HSV), Antiretroviral (HIV), Smallpox Vaccine, Herpes Labialis, Adenovirus (AdV) Disease – Oncology/Hematology DocuSign Envelope ID: F6909D29-21E5-4B74-A458-814972616A69 10/30/2023 20:24 EDT

10/30/2023

2

o Oncology (Pancreatic solid tumor, Lung (NSCLC), Metastatic Refractory Solid Tumors) o Medical Device

o Respiratory – Antihistamines (SAR), Asthma, COPD, Influenza (inhaled & vaccine), Pulmonary Fibrosis, Pneumonia

o Pediatrics

o Urology

o Wound Care

o Women’s Health – Oral Birth Control, Hypoactive Sexual Desire Disorder (HSDD) o MISC. – PDE-IV inhibitor, Sedation (Opioid Derivative), Smoking Cessation, Primary Immunodeficiency Disease (PI), Plasma Replacement

PROFESSIONAL EXPERIENCE

Oct. 2001- Present Pixley Scientific, Inc. / Senior / Principal / Lead Independent Clinical Monitor, Austin, Texas (All 1099 Contract Positions listed below): CRMG (Octapharma) / Regional Senior CRA 13Sep16 – Present CRMG (Monopteros) / Lead CRA 19Jul21 – 24Oct23

Brio (PRA Health Sciences) / Regional Senior CRA 10Aug15 - 10Jun16 Advanced Clinical (PPD / Sunovion) / Senior CRA 10Oct14 - 02Sep15 DOCS Resourcing (ICON) / Regional Senior CRA 16Sep12 - 14Mar14 John Galt Staffing (BioSante) / Regional Senior CRA 2012 - 2012 Trio (AptivSolutions) / Regional Senior CRA 2011- 2012 Trio (The Gnoman Group) / Regional Senior CRA 2011- 2012 Aerotek (Quintiles) / Regional Senior CRA 2010 - 2011 Northwestern University / Regional Lead CRA 2011 - 2012 Clinical Research Management, Inc. / Regional Senior & Lead CRA 2004-2011 (7 years)

ProTrials: Regional CRA / 2003-2004 (9 month)

Integrium: Regional CRA / 2002-2003 (10 months)

Medex Clinical Trail Services: Regional CRA / 2002-2002 (8 months) Effective Research: Regional CRA / 2001-2002

Feb. 2001- Nov. 2001 Bristol-Myers Squibb / Senior Independent Clinical Monitor, Princeton, New Jersey with KForce (W-2 Contract Position) Apr. 1999- Feb. 2001 Regional Clinical Research Scientist I, GlaxoWellcome, Research Triangle Park, North Carolina (Permanent Position) Oct. 1997- Apr. 1999 Regional Clinical Research Associate, Quintiles, Inc., Arlington, Virginia (Permanent Position)

Mar. 1997- Oct. 1997 Clinical Research Associate, Aronex Pharmaceuticals, Inc., The Woodlands, Texas (Permanent Position)

Aug. 1993- Mar. 1997 Clinical Research Associate, Pharmaco International, Inc., Austin, Texas (Nov. 95- Mar. 97) (Permanent Position)

Clinical Research Coordinator/Recruiter, Pharmaco International, Inc., Austin, Texas (Jun. 94 - Nov. 95) (Permanent Position) Clinical Data Associate Assistant, Pharmaco International Inc., Austin, Texas (Aug. 93 - Jun. 94) (Permanent Position)

BASIC DUTIES / RESPONSIBILITIES

Duties and responsibilities performed at my present and previous positions:

• President / Owner of Pixley Scientific Inc.: CRA duties listed below in addition to Company Management, Client Recruitment, Payroll, Tax Preparation and Training

• Senior / Principal Clinical Research Associate: Principal Investigator screening and recruitment, collection and QA of critical documents, qualification visits, initiation visits, monitoring visits, close-out visits, study newsletter, source document/worksheet and CRF (or DocuSign Envelope ID: F6909D29-21E5-4B74-A458-814972616A69 10/30/2023

3

eCRF) development, creation of CRF (eCRF) Completion Guidelines, create and maintain site and in-house monitoring tools, Investigator Meeting presentation preparation, North America CRA departmental meeting planning committee, query generation and resolution, query and data listings review and resolution, compliance review and education of FDA regulations, ICH guidelines, and GCP practices.

• Lead CRA / with Project Manager duties: Create and maintain all study / site tracking tools for study management, monitoring visits, regulatory document tracking, investigational product tracking, source documentation/worksheet development, S.O.P. development team, site budget negotiations, Clinical Monitoring Plan development & maintenance, facilitate CRA training, site preparation, monitoring tool development, and site/CRA/Project Management/Vendor/Sponsor liaison, Protocol development, eTMF Plan development, Safety Plan development, and CRA management.

• Clinical Research Coordinator/Recruiter: Subject recruitment, presentations of informed consents, study planning and conduction management, and sponsor / team communications.

• Data Management: Transcription, data and listings review, electronic data entry, query resolution and file management.

• Technical support as CRC: ECGs, phlebotomy, vital signs, blood harvesting, urine collection and urine harvesting, fecal collection and processing and subject search / check-in / check-out procedures.

PROFESSIONAL INVOLVEMENT

2018 ACRP-PM Certification Exam

2016 Finalist in PharmaTimes ‘Clinical Researcher of the Year’, April 201*-****-**** National Association of Professional Women – Member, March 2016 2015 Project Management for Team Members – GoSkills (23 lessons, certificate completion 09/29/15)

2014 Project Management for Clinical Research Professionals Course – ACRP - San Antonio, TX (2 day course)

2009-2015 Clinical Monitoring Plan, Report, & Study development: Northwestern University / CRMi (G) / Advanced Clinical

2008-2012 Lead CRA CHF Trial & Stem-Cell Transplant Trails for CHF, CLI, & PAD

2007-2008 Study Source Document and CRF Development, Vaccine Trial 2002 Attended ACRP Conference, Toronto, Canada

2000 Departmental Regional Meeting Planning Committee 1999 Attended ACRP Conference, Washington DC

1997 S.O.P. Development Team, Aronex

1996-Present Association of Clinical Research Professionals Member (15+ years) 1995-1996 Newsletter Editor - Three CNS Investigational Studies, Pharmaco Development of Phase I Monitoring Guidelines, Pharmaco ACADEMIC INVOLVEMENT

2001 Law School Admissions Test taken October, 2001 (w/ admission to Law School; although, did not attend)

1992-1993 Vice President, Univ. of Texas Pre-Pharmacy Association, Austin, TX 1992-1992 Social Chairman/Treasurer, University of Texas Pre-Pharmacy Association, Austin, Texas

1991-1992 Social Chairman, University of Texas Pre-Pharmacy Association, Austin, Texas

CONTINUING EDUCATION COURSES

1998-Present CEUs (24 CEUs / 2 years) to Maintain Certification DocuSign Envelope ID: F6909D29-21E5-4B74-A458-814972616A69 10/30/2023

4

June 2026 GCP Certificate good through 26Jun2026

2020 FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19(including updates)

2015 PMP Exam training course: GoSkills

2014 Project Management: GoSkills course

2014 Project Management for Clinical Research Professionals by ACPR (In- Depth Course, 12 CEUs: 04/23-24/2014)

Participating and Responding to R&D Quality Assurance Audits Refresher on Site Selection, Initiation, Monitoring & Closeout Visits 2013 Re-Consenting of Study Subjects

Translation of Documents / ICFs / Advertisements / Scales SAEs, Lab Report Review, and Code Breaking Procedures Submission of Amendments to IND Application

Project / Study Communications

Serious Breaches of GCP or the Trial Protocol to the MHRA Reallocation of IP between Investigational Sites

Clinical Study Applications to Regulatory Authorities and Ethics Committees

Financial Disclosure by Clinical Investigators

Protocol Violations / Deviations

Annual GCP Monitoring Knowledge and Assessment

2012 ACRP Global Conference Webinar – How to Make FDA Inspections as Painless as Possible: What to Expect, What to Do, and What not to Do. Oncology Foundation Module 1 & 2

Lymphoma Response Assessment

Introduction to European Union Clinical Trial Legislation Refresher on 21 CFR Part 50 & 54

Refresher on 21 CFR Part 312, Part D – Special Situations Refresher on 21 CFR Part 312, Part C – Sponsor and Investigator Responsibilities

Refresher on 21 CFR Part 312, Part B – Applications and Amendments Refresher on 21 CFR Part 312, Part A - Overview

Scientific Misconduct & Handling of Fraud

2011 Oracle EDC Training; Intro to the Clinical Drug Development Process: ICH Good Clinical Practice for Clinical Trial Sites Certification

(6 hr/6 Module course)

2010 Anti-kickback Statute and False Claims Act

ICH/GCP Refresher (5 hr course)

InForm EDC Comprehensive and ‘Train the Trainer’ Training RAVE / Medidata EDC Training (ongoing w/ ea. new RAVE protocol) Federal Internal Guidance Document for 1572 Forms

HIPAA 2 Guidelines

IRB Registration Requirement

2009 Velos EDC Training

2004-2006 Research Practitioner CEUs (Home Study)

2001 Princeton Review for LSAT exam & Completion of the LSAT Exam 2001 Research Practitioner CEUs (Home Study)

2000 MedTrack Workshop

2000 Suspicion of Clinical Fraud Workshop

1999 Application of Clinical Research Standards Workshop 1999 Principals of Clinical Research Workshop

1998 ACRP CCRC Prep Course

1997 ACRP Prep Course/Exam CRA Certification (13+ years certified) 1995-1996 Business Law I and II (Austin Community College) 1995 Ritual (Cult) Abuse

1995 Diagnostic and Statistical Manual of Mental Disorders (DSMIV) DocuSign Envelope ID: F6909D29-21E5-4B74-A458-814972616A69 10/30/2023

5

1994 Mycobacterium Avium Complex Infection in AIDS Patients 1994 Trauma Surgery of the Face

1994 Pulmonary Function Testing

1993 Family Systems, Structures and Evolved Roles

DocuSign Envelope ID: F6909D29-21E5-4B74-A458-814972616A69 10/30/2023

6

ADDENDUM

CLINICAL TRIAL EXPERIENCE:

*A Phase I, Single-Center, Single-Period, 9 Day Inpatient, Randomized, Double-Blind (third party unblind), Placebo-Controlled, Tolerance-Dependent, Ascending Single- and Multiple- Oral Dose Study to Determine the Safety, Tolerance, and Preliminary Pharmacokinetics of a PDE-IV Inhibitor in Healthy Male Subjects. A Phase I, Single-Center, Single-Period, 8 Day Inpatient, Double-Blind, Placebo-Controlled, Tolerance- Dependent, Ascending, Multiple- Oral Dose Study Designed to Evaluate the Safety and the Tolerability of a Specific Pancreatic Cholesterol Esterase Inhibitor in Healthy Normal Subjects.

*A Phase I, Single-Center, Single-Period, 3 Day Inpatient, Double-Blind, Randomized, Placebo-Controlled, Tolerance-Dependent, Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of an Anti-Inflammatory Designed for Prophylactic Therapy for Reperfusion Injury Following Pulmonary Thromboendarterectomy and Angioplasty or Thrombolytic Treatment for Myocardial Infarction.

*A Phase I, Single-Center, 7 Period, 21 Day Inpatient, Double-Blind, Placebo-Controlled, Parallel Investigation of the Safety and Pharmacokinetics of Increasing Single Doses of a Norepinephrine Inhibiting Antidepressant. A Phase I, Single-Center, 2 Period, Outpatient, Open-Labeled, Two-Treatment, Intravenous Crossover Study to Compare the Equivalence of the Systemic Exposure of a Novel, Short-Acting Synthetic Opioid Derivative When Synthesized By Different Routes.

A Phase I, Single-Center, 2 Period, 6 Day Inpatient, 2 Day Outpatient, Open-Label, Two-Treatment Crossover Study to Determine the Bioequivalence of a Proposed Commercial Dosage Formulation of a Quinolone Antibiotic.

A Phase I, Single-Center, 3 Period, 3 Day Inpatient, 3 Day Outpatient, Open-Label, Three Treatment Crossover Study to Evaluate the Pharmacokinetics of a Proposed Anti-inflammatory to be used for Treatment of Osteoarthritis or Rheumatoid Arthritis.

*A Phase I, Single Period, 37 Day, Double-Blind, Placebo-Controlled, Study of the Safety, Toleration, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Escalating Doses of a Cholesterol Absorption Inhibitor in male and female subjects with mild to moderate Hypercholesterolemia.

*A Phase I, Single Period, 14 day, Double-Blind, Placebo-Controlled, Study of the Safety, Tolerance and Pharmacokinetics of Single and Multiple Escalating Doses of a Tripeptide-copper Complex Dermal Solution in Healthy Male volunteers with vertex and mid-area pattern baldness. A Phase I, 2 Period, 10 Day Inpatient, 7 Day Outpatient, Open-Label, Non-randomized, Pharmacokinetic Study of the oral Bioavailability of a dibenzoxepinopyridine tetracyclic compound in Healthy, Normal, Young and Elderly, Male and Female Volunteers to be used in the Treatment of Depression. A Phase I, 3 Period, 4 Days Inpatient, 5 Days Outpatient, Open-Label, Single-Center Study to determine the Kinetics of Norgestimate, and EE after Administration of Oral Birth Control to Healthy, Female volunteers. A Phase I, 2 Period, 4 Days Inpatient, Open-Label, Randomized, 2-way crossover, Tablets/Capsules (Performed as Two Separate Studies), Single Dose Bioequivalence Study of a Dopamine Receptor Agonist and Parlodel

(Snaptabs and Capsules) in Healthy Adults for Treatment of Dysfunctions associated with Hyperprolactinemia. A Phase I, Open-Label, Randomized, Single-Dose, Crossover Study of a Fast Dissolving Azalide Antibiotic in Fed and Fasted States in Healthy, Adult Subjects.

A Phase I, 2 Period, 4 Days Inpatient, Open-Labeled, Crossover Study to Determine the Bioequivalence of the Proposed Commercial Dosage Formulation of Quinolone Antibiotic in Young Healthy Males.

First time in man

DocuSign Envelope ID: F6909D29-21E5-4B74-A458-814972616A69 10/30/2023

7

Lauri A. Pixley

ADDENDUM CONTINUATION:

*A Phase I, Single-Centered, 2 Period, 5 Day, 6 Group, Randomized, Double-Blind, Placebo-Controlled, Tolerance-Dependent, Dose Escalation, Single Intravenous Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of a highly selective adenosine A1-Receptor Antagonist Diuretic in Healthy Male Volunteers for the Treatment of Edema, Secondary to Congestive Heart Failure. A Phase III, Multi-Centered, 4 Period, 411 Day, Randomized, Double-Blind, Placebo Controlled, 3 way Crossover, followed by a 1 Year Open-Labeled Study to Assess the Efficacy of an Antipsychotic for the Treatment of Patients with Schizophrenia and Schizoaffective Disorder. (Two Protocols) A Phase III, Multi-Centered, Open-Labeled, 3-way Crossover with Haldol, Protocol Extension of a Serotonin -

(5-HT2) Receptor Antagonist Psychotropic, in a Study to Assess the Efficacy of an Antipsychotic for the Treatment of Patients with Psychotic Disorders including Schizophrenia, Schizophreniform Disorder, and Schizoaffective Disorder.

A Phase III, Multi-Centered, 4 Period, 411 Day, Randomized, Double-Blind, Placebo-Controlled, 4 way Crossover, followed by a 1 Year Open-Labeled Study to Assess the Efficacy of an Antipsychotic for the Treatment of Patients with Schizophrenia or Schizoaffective Disorder. A Phase III, Multi-Centered, Double-Blind (into an Open-Label Study), Dose Ranging 2-way Crossover with Haldol, to study the Efficacy and Tolerability of a Quinolinone Derivative Postsynaptic Dopamine Receptor Antagonist and a Presynaptic Dopamine Agonist in Acutely Relapsing Hospitalized Schizophrenic Patients. A Phase I, Single-Centered, Open-Labeled, Multiple-Dose, Single-Treatment Study to Evaluate the Steady State Pharmacokinetics of Naproxen in a Fixed Combination tablet with Misoprostol after Oral Administration by Healthy, Elderly Male and Female Subjects Under Fasting and Fed Conditions. A Phase I, Single-Centered, Open-Labeled, Multiple-Dose, Three-Treatment, Three Period, Six-Sequence Crossover Study to Evaluate the Steady State Pharmacokinetics and Oral Bioavailability of Naproxen and Misoprostol in a Fixed Combination Tablet, A Co-Administered Napratec Dose of Naproxen and Misoprostol, and Naprosyn in Healthy Young Female and Male Subjects Under Fasting and Fed Conditions. A Phase I, Single-Centered, Open Labeled, Single Dose, 4-Treatment, Single Period Study to Evaluate Oral Bioavailability of Naproxen & Misoprostol, the Safety & Tolerability of Single Fixed Combination Tablet of Naproxen & Misoprostol, A Co-Administered Napratec Dose of Naproxen & Misoprostol, A Fixed Combination of Naproxen & Placebo, & a tablet of Naprosyn, in Young Healthy Female & Male Subjects.

A Phase II/III, Open-Labeled, Multiple Dose, Single-Period, Multicenter Study to Evaluate the Safety and Efficacy of Various Doses of a Polyene Antibiotic in Non-Neutropenic Patients With Candidemia. A Phase III, Prospectively Randomized, Double-Blind, Multiple Dose, Single-Period, Comparative Multicenter Study to Evaluate Efficacy and Safety of a Polyene Antibiotic and Amphotericin B for Empiric Antifungal Treatment in Neutropenic Patients.

A Phase II, Open-Labeled, Non-Comparative, Multiple Dose, Single-Period, Multicenter Study to Evaluate the Clinical Efficacy and Safety of a Polyene Antibiotic in the Treatment of Patients with Proven or Probable Aspergillus Infection Who are Failing Standard Parenteral Antifungal Therapy Due to Lack of Response or Intolerance to Amphotericin B or Liposomal Amphotericin. A Phase II, Open-Labeled, Multiple-Dose, Compassionate Use Study for the use of a Polyene Antifungal for the Treatment of Patients with Proven Systemic Fungal Infections Who Have Failed or Are Intolerant of all Marketed Systemic Antifungal Therapy.

First time in man

DocuSign Envelope ID: F6909D29-21E5-4B74-A458-814972616A69 10/30/2023

8

Lauri A. Pixley

ADDENDUM CONTINUATION:

A Phase I, Single Center, Open-Labeled, Randomized, Two Period, Two-way Crossover, Single Dose Study in Healthy Human Subjects to Evaluate the Effect of Food on the Bioavailability of a drug used in the

Treatment of Diarrhea Associated with Cryptosporidiosis Caused by Cryptosporidium parvum in HIV- positive Adults and AIDS Subjects.

A Phase III, Multi-Center, Open-Label, Randomized, Multiple-Dose Study to Compare the Safety and Efficacy of an Antibiotic vs. Ceftriaxone Sodium and Erythromycin Followed by Clarithromycin and Amoxicillin/Clavulanate in the Treatment of Serious Community-Acquired Pneumonia in Hospitalized Adults

A Phase III/IV, Multi-Center, Randomized, Third Party Blinded Trial Comparing Oral Therapy of Trovafloxacin (Trovan ) vs Oral Ciprofloxacin (Cipro ) (500 mg BID) Plus Clindamycin (Cleocin )

(300 mg QID) for the Outpatient Treatment of Diabetic Foot Infections A Phase III, Multi-Center, Multi-Dose, Double-Dummy, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate Three Non-Sedating Antihistamine Doses (30mg, 60 mg, 90mg) and Loratadine, When Administered to Subjects with Seasonal Allergic Rhinitis A Phase II, Multi-Center, Open-Labeled, Single-Dose, Pharmacokinetic Study to Evaluate the Character- ization to Neonates ages 0 to 6 months with Symptoms Associated with Gastroesophageal Reflux Disorder A Phase III, A Randomized, Double-Blind, Parallel-Group Trial of Inhaled Fluticasone Propionate/GR 106642X 220 mcg BID and 440 mcg BID in Adolescent and Adult Subjects With Asthma A Phase II, A Single Center, Randomized, Double-Blind, Placebo-Controlled Parallel Group Study of Single Oral Doses of 25mg and 250mg of an investigational pain reliever and 550mg of Naproxen Sodium in Healthy Male Subjects with Postoperative Dental Pain Under Local Anesthesia A Phase III / IV, A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Study to Investigate the Efficacy and Safety of Inhaled Zanamivir 10 mg Administered Twice Daily for Five Days in the Treatment of Influenza in Patients 12 Years or Over Diagnosed with Asthma or Chronic Obstructive Pulmonary Disease

A Phase III, A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial Evaluating the Safety and Efficacy of the DISKUS Formulations of an Investigational Medication and Fluticasone Propionate 500mcg BID Individually and in Combination as Compared to Placebo in COPD Subjects A Phase III, A Randomized, Double-Blind, Parallel-Group, Comparative, Trial of Inhaled Fluticasone Propionate via an Investigational Device 250mcg BID, 500 mcg BID, and Placebo BID in Patients with Chronic Obstructive Pulmonary Disease (COPD)

A Phase III, A Randomized, Multicenter, Partially Double-Blinded, Repeat Dose, Cross-Over Study to Assess the Safety and Tolerability, Pharmacokinetics, and Antiviral Effect of Two Doses of an Investigational Medication Compared with Amprenavir (1200 mg BID) when given for 28 days to Subjects Infected with HIV-1

A Phase III, Randomized, Double-Blind, Placebo-Controlled Evaluation of Valacyclovir for the Prevention of Herpes Simplex Virus Transmission in Heterosexual Couples DocuSign Envelope ID: F6909D29-21E5-4B74-A458-814972616A69 10/30/2023

9

Lauri A. Pixley

ADDENDUM CONTINUATION:

A Phase II / III 48-Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and safety of an Investigational Medication 300mg Once Daily vs. an Investigational Medication 150mg BID in Combination with Zidovudine 300mg BID and Efavirenz 600mg Once Daily in Antiretroviral-Naïve Adults and Adolescents with HIV-1 Infection A Phase III, Study for the Evaluation of the Safety and Antiviral Efficacy of a Novel HIV-1 Protease Inhibitor in Combination with d4T and 3TC as Compared to a reference Combination Regimen A Phase III, Double-Blind Comparison of 80 mg and 160 mg Doses of Pravastatin with Placebo in Hypercholesterolemic Subjects

A Phase III, Multicenter, Double-Blind, Placebo Controlled Trial of an Investigational Antidepressant in the Treatment of Children and Adolescents with Depression A Phase III, Multicenter, Double-Blind trial of an Investigational Antipsychotic vs. Olanzapine in the treatment of Acute Schizophrenia

A Phase II, Parallel Group, Efficacy and Safety Study of and Investigational Drug vs. its Vehicle QD

(Double-Blind), Minoxidil 5% vs. its Vehicle BID (Double-Blind) and the Investigational Drug QD vs. Minoxidil 5% BID (Single-Blind) in Adult Males with Andogenetic Alopecia A Phase III, Multicenter, Double-Blind Placebo-Controlled Trial of an Investigational Drug in Depressed Adolescents

A Phase IIB, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Clinical Efficacy of Two Different Doses of an Investigational Drug Administered Intravenously to Subject with Active Rheumatoid Arthritis While Receiving Methotrexate A Phase III, Randomized, Double-Blind, Multicenter, Comparative Study of 5-Day Oral Dosing of an Investigational Drug vs. Oral Clarithromycin in the Treatment of Mild to Moderate Community-Acquired Pneumonia

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Two Fixed Doses of an Investigational Drug in the Treatment of Hospitalized Patients with Acute Mania A Phase III, Randomized Trial of an Investigational Drug vs. Enalapril, to study the Utility in Reducing Events in Subjects with Heart Failure

A Phase III, Randomized, Double-Blind, Active Controlled Evaluation of the Antihypertensive Response to an investigational drug in Subject Uncontrolled on Calcium-Channel Blocker Monotherapy A Phase III, Safety and Efficacy of Fixed Combination of an investigational drug as First Line Therapy in Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic with Diet and Exercise A Phase III, Clopidogrel for Reduction of Events During Observations (CREDO): “A Double-Blind, Randomized Trial of Clopidogrel 300 mg Loading Dose and Aspirin 325 mg followed by Clopidogrel 75 mg and Aspirin daily Compared with Placebo Loading Dose Followed by Clopidogrel 75 mg and Aspirin daily for the Prevention of Vascular Events and All-Cause Mortality in Patients Undergoing Percutaneous Coronary Intervention

DocuSign Envelope ID: F6909D29-21E5-4B74-A458-814972616A69 10/30/2023

10

Lauri A. Pixley

ADDENDUM CONTINUATION:

A Phase II Study to Evaluate the Efficacy and Safety of an investigational drug as Adjunctive Therapy in Patients with Partial Seizures

A Phase III, Multicenter, Open-Label, Class II Drug Study to Continue the Safety Assessment of an Investigational Drug in Children with Attention Deficit Hyperactivity Disorder A Phase III, Multicenter, Double-Blind, Placebo-Controlled Study to Compare the Effects of an Investigational Drug with Placebo on the Combined Incidence of Cardiovascular Mortality, Resuscitated Cardiac Arrest, Non-Fatal Myocardial Infarction, Non-Fatal Stroke, Need for Coronary Revascularization and Urgent Hospitalization for Angina Pectoris in Subjects with Coronary Artery Disease A Phase II, Double-blind, Randomized, Placebo-Controlled Study to Assess the Efficacy and Safety of

(Fosrenol®) for the Reduction of Serum Phosphorus in Subjects with Stage 3 and 4 Chronic Kidney Disease who Have Elected Serum Phosphorus Levels

A Phase III, Long-Term, Open-Label, Extension study to Assess the Safety of an Investigational Drug in Dialysis Patients who have Received Lanthanum Carbonate (Fosrenol®) in a Previous Trial and Wish to Continue Treatment

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of a Subcutaneous Investigational Medication in Patients with Idiopathic Pulmonary Fibrosis A Phase III, Open-Label, 2-Group (Continuing Dose and Escalating Dose), Study of the Safety and Efficacy of a Subcutaneous Investigational Medication in Patients with Idiopathic Pulmonary Fibrosis A Phase III, Randomized, Evaluator-Blinded, Multi-Center Study Comparing the Efficacy and Safety of an Investigational Device and Bulking Agent with Contigen® in Female Patients with Stress Urinary Incontinence

A Phase III, Multicenter, Prospective, Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of an Investigation Medication at Low-Dose and High Dose in Patients with Mild to Moderate Hypertension Uncontrolled on Monotherapy Inclusive of the Difficult-to-Treat Population A Phase III, A Multicenter, Double-Blind, Active and Placebo Controlled Study of Aggrenox® vs. Clopidogrel + Aspirin, With and Without Micardis® for the Prevention Regimen For Effectively Avoiding Second Strokes (PRoFESS)

A Phase III, Multi-Center, Randomized, Double-Blind, Fixed Dose, Comparison Study of the Safety, Tolerability, and Immunogenicity of an investigational Smallpox Vaccine with Dryvax® Smallpox Vaccine in Adults without Previous Smallpox Vaccination

A Phase IIIb, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial to Assess Safety and Tolerability during Treatment of Type 2 Diabetes with Usual Diabetes Therapy and either Cycloset or Placebo

A Phase IIIb, Multi-Center, Open Labeled, Randomized, Parallel Group Pilot Study to Assess the Efficacy and Safety of Fosrenol® and Sevelamer Hydrochloride in Patients Receiving Heamodialysis for End Stage Renal Disease

A Phase IIIb, Prospective, Multicenter, Open-Label, Randomized, Cross-Over Study to Compare the Efficacy and Safety of Fosrenol® and Sevelamer Hydrochloride in Patients Receiving Heamodialysis for End Stage Renal Disease

DocuSign Envelope ID: F6909D29-21E5-4B74-A458-814972616A69 10/30/2023

11

Lauri A. Pixley

ADDENDUM CONTINUATION:

A Phase I, Randomized Placebo-Controlled, Double-Blind, Study of the Safety, Reactogenicity, and Immunogenicity of a Recombinant M2e Influenza-A Vaccine Candidate in Healthy Adults A Phase IIb, Multi-Center, Double-Blind, Randomized, Placebo Controlled Trial of a Ethanol Extract from the Andrographis paniculata plant in Patients with Mild or Moderate Ulcerative Colitis With or Without Mesalamine

A Phase II, Multi-Center, Randomized, Trial of Standard Care vs. Standard Care with Peritoneal Ultrafiltration in

Contact this candidate