ContractPost-Authorisation Study Agreement • May 11th, 2020
POST-AUTHORISATION STUDY AGREEMENT SMLOUVA O PROVEDENÍ POREGISTRAČNÍ STUDIE For Protocol CC-10004-PSOR-013 APPRECIATE™ (APREmilast ClinIcAl Treatment Experience in psoriasis): A Multi-center, Retrospective Observational Study of Real-World Experience of Psoriasis Patients Treated with Apremilast in Clinical Dermatology Practice. Pro protokol CC-10004-PSOR-013 APPRECIATE™ (APREmilast ClinIcAl Treatment Experience in psoriasis, zkušenosti s léčbou apremilastem u lupénky v klinické praxi):multicentrická, retrospektivní observační studie reálných zkušeností pacientů s lupénkou léčených apremilastem v klinické dermatologické praxi. This post-authorisation study agreement (hereinafter, the “Agreement”) is by and between: Tato smlouva o provedení poregistrační studie (dále„smlouva”), byla uzavřena mezi těmito stranami: Celgene International II Sàrl, a limited liability company organized under the laws of Switzerland, having its principal office at Rue de Pré-Jorat 14, 2108 Couvet, Switzerland
POST-AUTHORISATION STUDYAGREEMENT CONTRATTO DI STUDIO DI POST-AUTORIZZAZIONE For Protocol CC-5013-MDS-010 per Protocollo CC-5013-MDS-010 This Post- Authorisation Study Agreement (hereinafter, the “Agreement”) is by andbetween: Il presente Contratto di...Post-Authorisation Study Agreement • March 3rd, 2016
This Agreement is effective as of the last date of signature below (the “Effective Date”). Il presente Contratto sarà efficace a partire dalla data dell’ultima sottoscrizione (la “Data di iniziodella validità”). WHEREAS PREMESSO CHE (a) The Sponsor conducts business in the development of therapeutic products,compounds, and reagents; (a) Lo Sponsor svolge attività di sviluppo di prodotti, composti e reagenti per fini terapeutici; (b) The Institution and the Investigator have acquired expertise in the conduct of clinical trials, and post-authorisation studies; they both have appropriate facilities and personnel for the performance of those activities; (b) L’Istituto e lo Sperimentatore hanno acquisito competenze in materia di conduzione di trial clinici e di studi di post autorizzazione e sono dotati di strutture appropriate e di personale qualificato per lo svolgimento di taliattività; (c) The Investigator is an employee of theInstitution or practices medicine in the context of
