AMENDMENT Nº 5(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
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 parties are jointly willing to amend the above-referred Agreement; Now, therefore the above-referred Agreement shall be amended by including a data entry fee and the following amended wording shall be effective as of the date of signature of this amendment:• Data Entry fee for subjects who have agreed to participate in Protocol Amendment 13 participation if completed within 4 weeks starting from 27 th Feb
ContractGlobal Clinical Site Agreement • August 31st, 2017
AMENDMENT Nº 2 DODATEK ČÍSLO 2 (hereinafter Amendment) (dále jen dodatek) to the ke Global Clinical Site Agreement No. 08/OVZ/15/005-P(hereinafter Agreement) Smlouvě o provedení klinického hodnocení č.08/OVZ/15/005-P (dále jen smlouva) dated 02Mar2015, ze dne 2. 3. 2015 podpisu smlouvy, This Amendment is made by and between Tento dodatek se uzavírá mezi (1) PAREXEL International Czech Republic s.r.o.Sokolovska 651/136a 186 00 Prague 8 Czech RepublicCompany No: 27160360 Tax ID No: CZ27160360represented pursuant to the Power of Attorney dated 7 December 2010 by MUDr. Michaela Ticha (hereinafter to be referred to as “CRO”) (1) PAREXEL International Czech Republic s.r.o.Sokolovská 651/136a 186 00 Praha 8 Česká republikaIČ: 27160360 DIČ: CZ27160360zastoupená na základě plné moci ze dne 7. prosince 2010 MUDr. Michaelou Tichou(dálejen „CRO“) and a (2) Fakultni nemocnice Ostrava17. listopadu 1790/5 708 52 Ostrava Czech RepublicCompany No: 00843989 Tax ID No: CZ00843989 Trust deed of MoH dated
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
