A Corporative Latin America CRO

1. CompanyProfile www.southconealliance.com

2. OUR COMPANY Multinational Company that provides Services for Pharmaceutical Companies founded in 2011 by Clinical Trials Support (Chile) and Pentha Research(Argentina.)

3. The objective of this association is to provide full service in Clinical Research in Latin America. The local approach of our associates and their experience in regulatory issues give SOUTH CONE ALLIANCE the necessary strength to offer a full and multinational service to our clients.

4. South Cone Alliance administration has a Directorythatcontrolstheprocessesprovidedbyourclients, assuming a leadershipwithinourproyects. South ConeAlliance merges from the habilities and capablities of our members creating a strong skill identity. South ConeAlliance is a high value alternative in Latin America.

5. FOUNDERS General CompaniesInformation: ClinicalTrials Support Company name : CLINICAL TRIALS SUPPORT LTDA Head office address Av Los Leones 2532, Providencia-Santiago CHILE Phone number +56 2 205 35 44 Web sitewww.clinicaltrials.cl Company status LimitedCorporate Contactinformation Carlos Cáceres –CEO -carlos.caceres@clinicaltrials.cl General CompaniesInformation: PenthaResearch CompanyName: PenthaResearch CompanyAddress: Paraguay 1570, Buenos Aires (C1061ABD), Argentina Phone/FAX: +54-11-58113881 Web Site: www.pentharesearch.com Company Status: LLC ContactInformation: Gerardo M.Uviedo, MD-CEO -info@pentharesearch.com

6. COMPANY FEATURE Full-Service ClinicalOutsourcingSolutions in branchesbased in eightdifferentcountries.

7. Countriestobeinvolved Argentina Brasil Chile Colombia Ecuador Perú Paraguay México

8. FEASIBILITY STUDIES Analysis on protocol in order to determine Best country, PI, site to conduct the trial EnrolmentProjections Overallcosts Check up/comparison with historical database of like trial information Develop, distribute and assess site feasibility survey Providepatient/site/monthrecruitmentestimates Data base with more than 1000 Investigators in different specialities

9. REGULATORY AFFAIRS Advice on Regulatory procedures in countries of operation Ethicscommitteesubmissions SiteRegulatory Files management Management of IRB documents and operations Local and Regional Regulatory Agency approvals Import /Exportlicenses Customconsultancy and management

10. STUDY START UP StudyDesign, Protocol/CRF development ClinicalDevelopmentPlans (PM, Monitoring, Quality, Communication, etc) CertifiedTranslation of applicabledocuments Investigator/siteselection & patientrecruitmentstrategies Investigator Meeting Planning and execution Local regulatorydocumentscollection & Management Preparation of country specific product labels Customconsultancy and management

11. LOCAL PROJECT MANAGEMENT This service provides sponsors/clients with legal representation in Latin America for the conduction of a clinical trial enabling South Cone Alliance to: Execute contracts with PIs, sites & vendors on behalf of the client Administrate PI and vendor grants Represent sponsor at a local/ central EC´s and IRB´s Represent sponsor for importation purposes

12. CLINICAL TRIAL MANAGEMENT Activities involving Ongoing trial Management Regulatory package preparation in accordance with country specific requirements Patientscreening and randomization Sitemonitoring Project tracking via EDC system Management of Drug supply, laboratories and local couriers Local and central safety management Communication with sites, sponsor and vendor /TLC, FtoF, internal project meetings)

13. REGIONAL PHARMACOVIGILANCE Receiving/Processing/Archiving adverse events in countries of operation Medicalmonitoring Ethicscommittee/IRB & MOH submissions Ensure compliance with local & International requirements

14. QUALITY ASURANCE SERVICES Conduct of quality GCP audits Conduct of contract vendor/SUPPLIER AUDITS Conduct internal (staff) and external (sites) GCP training Development of Quality Plans, Quality Manuals, SOPs and SQPs Operational Headquarters successfully audited by sponsors.

15. EARLY PHASE DEVELOPMENT DIVISIONS Itconsists of a exclusive suites located in ourbranchesspeciallyequipedtodevelopeearlyphasetrials (First in Human/IIa), combinedwith a highcomplexityfacilityiesmeetingalltherequirementsneededforsuccessfulexecution of thesestudies.

16. TRAININGS GCP Training ProgramProgramsfor: –Investigators –CRAs –StudyCoordinators

17. South ConeAlliance 1220 N. MARKET STREET SUITE 806 WILMINGTON -NEW CASTLE DELAWARE 19801 1 (302) 669-9100 corporate@southconealliance.com Office ARGENTINA Paraguay 1570-C1061ABD Buenos Aires +54-11-4813.9410 Office CHILE Av. Los Leones 2532 –601 Providencia Santiago +56-2-205.3544