Common Contracts
1 similar Global Clinical Site Agreement contracts
AMENDMENT Nº 4(hereinafter Amendment) to theGlobal Clinical Site Agreement (hereinafter Agreement) dated 11.February 2010, This Amendment is made by and between (1) PAREXEL International Czech Republic s.r.o.,Sokolovská 651/136a, 186 00 Prague 8,...Global Clinical Site Agreement • November 3rd, 2017
Controlled Trial of Neratinib (HKI-272) After Trastuzumab in Women with Early-Stage HER-2/neu Overexpressed/Amplified Breast Cancer” (hereinafter Study)Neratinib (HKI-272) (hereinafter Study Drug) WHEREAS, SPONSOR is the sponsor of the multi-center/multi-centre Study to clinically evaluate the Study Drug; WHEREAS, SPONSOR and PAREXELInternational Czech Republic s.r.o.,(hereinafter CRO or an Affiliate have agreed (under a separate written agreement) that CRO will act on behalf of SPONSOR as its authorized representative and agent and in its own name; WHEREAS, the parties have entered into the above-referred Agreement; WHEREAS, the Sponsor has amended the Protocol (copy to be provided to Site) to extend the Study subject follow-up period. The follow- up period has 2 parts; Part B is the expansion of the follow-up period from 2 years through 5 years (+90 days) post randomization and Part C, long- term follow-up of overall survival. WHEREAS, the parties are jointly willing to amend the abo
