Contract
DODATOK č. 1 K ZMLUVE O KLINICKOM SKÚŠANÍ | AMENDMENT no. 1 TO THE CLINICAL STUDY AGREEMENT |
Prvý dodatok (ďalej len “Dodatok”) k Zmluve o klinickom skúšaní účinnej odo dňa 16. januára 2019 (ďalej spolu ako “Zmluva”), uzavretej medzi spoločnosťou AbbVie s.r.o., Karadžičova 10, 821 08 Bratislava, Slovenská republika, IČO: 46640231, DIČ: 2023529057, IČ DPH: SK2023529057, zákonný zástupca: Xxxxxxxxx Xxxxx, M.D., zapísanou v obchodnom registri Okresného súdu Bratislava I, oddiel Sro., vložka č. 81375/B, deň zápisu: 11.05.2012 (ďalej len spoločnosť “AbbVie”) a Fakultná nemocnica s poliklinikou X.X.Xxxxxxxxxx Banská Bystrica, Nám. L. Svobodu 1, 975 17 Banská Bystrica, Slovenská republika, RN: 165 549, RN for tax: 2021095670, zastúpená Ing. Xxxxxx Xxxxxxxxxxx, MBA, riaditeľkou (ďalej len „Zariadenie“) přičom za vykonanie Skúšania v Zariadení je zodpovený („Zodpovedný skúšajúci“), na účely poskytovania služieb súvisiacich s protokolom č. M16-047 s názvom „Randomizované, dvojito zaslepené, placebom kontrolované skúšanie fázy 3 s cieľom posúdií Upadacitinib v kombinácii s lokálnymi kortikosteroidmi u dospievajúcich a dospelých účastníkov so stredne íažkou až íažkou atopickou dermatitídou” (ďalej len “Protokol”) vo vzťahu k Upadacitinib ABT-494 („Skúšaný liek“). | First Amendment (the “Amendment”) to that certain Clinical Study Agreement effective 16th of January 2019 (collectively hereinafter the “Agreement”), between AbbVie s.r.o., Karadžičova 10, 821 08 Bratislava, Slovak Republic, RN: 46640231, RN for tax: 2023529057, RN for VAT: SK2023529057, Legal Representative: Xxxxxxxxx Xxxxx, M.D., Company is registered in Trade Register of District Court Bratislava I. Part Sro., Insertion no. 81375/B, date of registration 11 May 2012 (“AbbVie”) and Fakultná nemocnica s poliklinikou X.X.Xxxxxxxxxx Banská Bystrica, Nám. L. Svobodu 1, 975 17 Banská Bystrica, Slovak Republic, RN: 165 549, RN for tax: 2021095670, represented by Xxx. Xxxxxx Xxxxxxxxxx, MBA, Director (the „Institution“) while (“Principal Investigator”) is responsible for the conduct of the Study at Institution, for services relating to Protocol No. M16-047 entitled “A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Combination with Topical Corticosteroids in Adolescent and Adult Subjects with Moderate to Severe Atopic Dermatitis” (“Protocol”) in relation to Upadacitinib ABT- 494 the (“Study Product”). |
Pod podmienkou riadneho uzavretia tohto Dodatku a v súlade s podmienkami Zmluvy sa zmluvné strany týmto dohodli na nasledovných zmenách Zmluvy: | Subject to the full execution of this Amendment and in accordance with the terms of the Agreement, the parties hereby agree to amend the Agreement as follows: |
1. ZMENA ROZPOČTU: Z dôvodu prijatia dodatku k Protokolu (ďalej len “Dodatok k protokolu”) a predlĺženie Skúšania, sa rozpočet stanovený v Prílohe A Zmluvy ruší v celom rozsahu a nahrádza sa Prílohou A priloženou k tomuto Dodatku. | 1. BUDGET AMENDMENT: Pursuant to amending the Protocol by Amendment (“Protocol amendment”) and extension of the Study, the Budget set forth in Exhibit A of the Agreement shall be deleted in its entirety and replaced with the attached Exhibit A. |
Pojmy, ktoré nie sú inak definované v tomto Dodatku, majú význam, ktorý im je pripísaný v Zmluve. Pokiaľ nie sú výslovne zmenené týmto Dodatkom, všetky ostatné podmienky Zmluvy zostávajú naďalej v plnej platnosti a účinnosti po dobu trvania Zmluvy. Tento Xxxxxxx nadobúda účinnosť dňom jeho podpisu všetkými zmluvnými stranami. | Terms not otherwise defined herein shall have the meanings ascribed to such terms in the Agreement. Except as specifically amended by this Amendment, all other terms and conditions of the Agreement shall continue in full force and effect during the term of the Agreement. This Amendment shall be effective upon full execution by all parties. | ||
NA DÔKAZ ČOHO každá zo zmluvných strán nechala tento Dodatok podpísať v jej mene svojim oprávneným zástupcom. | IN WITNESS WHEREOF, each of the parties has caused this Amendment to be executed by its authorized representative in its name and on its behalf. | ||
AbbVie s.r.o. | FAKULTNÁ NEMOCNICA S POLIKLINIKOU X.X. XXXXXXXXXX BANSKÁ BYTRICA | ||
Exhibit A | ||||
BUDGET SUMMARY AND PAYMENT SCHEDULE | ||||
INSTITUTION | ||||
Principal Investigator | ||||
Institution | ||||
Study Product | Protocol /Study | |||
Upadacitinib | M16-047 | |||
The maximum number of subjects that can be enrolled per site: | 5 | |||
Upon written prior AbbVie approval, Site may enroll additional subjects: | 10 | |||
Total Cost per Completed Subject (See Per Subject Costs- Base Study) | 3.007.80 | |||
TOTAL COST FOR ALL SUBJECTS: | 45.117.00 | |||
SUBJECT VISIT PAYMENT SCHEDULE: Payments will be made in accordance with Compensation Section of the Agreement as follows: | ||||
Payments for subject visits will be made twice per year following enrollment of the first subject at the site. Payments will be made after data is entered by Institution via the Electronic Data Capture (EDC) system and reviewed by AbbVie, and will correspond to amounts listed in Per Subject Costs to Exhibit A. Institution understands that all payments are subject to subsequent verification by AbbVie and will be adjusted per Compensation Section of the Agreement if necessary. | ||||
ADDITIONAL STUDY FEES: Payment shall be made within 45 days of receipt and approval of invoice. See "Site Costs" attachment for details | ||||
TOTAL ADDITIONAL STUDY FEES | 36.414.80 | |||
TOTAL BUDGET | 81.531.80 | |||
PAYMENT INFORMATION: | ||||
ALL PAYMENTS WILL BE MADE IN | EUR | |||
Payments shall be made payable to: | ||||
Contact information for Individual at Institution to receive payment remittance notifications and study correspondence: | Payment Method: | |||
Ref: (if applicable) | ||||
Bank Name: | ||||
Bank Contact: | ||||
Bank Address: | ||||
Bank ABA Routing #: | ||||
CHECKING Account #: | ||||
Ref: | ||||
Remittance Address: | ||||
Contact Name: | ||||
Phone Number: | ||||
Fax Number: | ||||
Email: | ||||
Contact information for Individual at Institution to receive payment information: | Contact Name: | |||
Email: | ||||
Individual and Address to receive Invoices | ||||
Per Visit costs | |||||
Visit | Procedures Sub Total | Non Procedures Sub Total | Total Cost Per Visit | ||
SV | 101.70 € | 69.60 € | 171.30 | € | |
BL | 96.60 € | 68.40 € | 165.00 | € | |
Wk2 | 46.50 € | 43.20 € | 89.70 € | ||
Wk4 | 39.90 € | 47.10 € | 87.00 € | ||
Wk8 | 45.30 € | 47.10 € | 92.40 € | ||
Wk12 | 42.60 € | 47.10 € | 89.70 € | ||
Wk16 | 87.30 € | 68.40 € | 155.70 | € | |
Wk20 | 34.80 € | 47.10 € | 81.90 € | ||
Wk24 | 35.10 € | 47.10 € | 82.20 € | ||
Wk32 | 45.90 € | 47.10 € | 93.00 € | ||
Wk40 | 42.00 € | 47.10 € | 89.10 € | ||
Wk52 | 84.00 € | 68.40 € | 152.40 | € | |
Wk64 | 34.80 € | 47.10 € | 81.90 € | ||
Wk76 | 79.50 € | 68.40 € | 147.90 | € | |
Wk88 | 34.80 € | 47.10 € | 81.90 € | ||
Wk100 | 81.90 € | 68.40 € | 150.30 | € | |
Wk112 | 34.80 € | 47.10 € | 81.90 € | ||
Wk124 | 79.50 € | 68.40 € | 147.90 | € | |
Wk140 | 79.50 € | 68.40 € | 147.90 | € | |
Wk152 | 12.30 € | 2.85 € | 15.15 € | ||
Wk164 | 64.80 € | 68.40 € | 133.20 | € | |
Wk176 | 12.30 € | 2.85 € | 15.15 € | ||
Wk188 | 62.40 € | 68.40 € | 130.80 | € | |
Wk200 | 12.30 € | 2.85 € | 15.15 € | ||
Wk212 | 64.80 € | 68.40 € | 133.20 | € | |
Wk224 | 12.30 € | 2.85 € | 15.15 € | ||
Wk236 | 62.40 € | 68.40 € | 130.80 | € | |
Wk248 | 12.30 € | 2.85 € | 15.15 € | ||
Wk260 | 64.80 € | 68.40 € | 133.20 | € | |
30D F/U V | 41.40 € | 40.35 € | 81.75 € | ||
Total costs per Patient: | 3.007.80 € | ||||
CONFIDENTIAL/DÔVERNÉ
Template/Vzor: Slovakia_Budget Amdt Template_24Oct2016
Document Title/Nazov Dokumentu: M16-047 Slovakia AMD 1 to CSA - 2 Agmt Per Site INST, FNsP FRD BB MUDr.
M16-047 00152218.1 | ||||||
Conditional Procedures | ||||||
| ||||||
Principal Investigator | ||||||
Institution | ||||||
Study Product | Upadacitinib | M16-047 | ||||
Code | Conditional Procedure | Price per Unit | Units / subject | Units / site | Total Cost | |
7.950.60 | ||||||
.
M16-047
00152218.1
Additional Study Fees | |||||
Principal Investigator | |||||
Institution | |||||
Study Product | Upadacitinib | Protocol Number | M16-047 | ||
Additional Study Fees (to be paid within 45 days of receipt and approval of itemized invoice) *AbbVie may, at its discretion, approve payment of more Units of a particular Budget item than estimated below without an amendment to Agreement, provided that the additional payment does not cause the total cost of the Budget set forth in Exhibit A to be exceeded. | |||||
ALL PAYMENTS WILL BE MADE IN | EUR | ||||
Item Header | Description | Estimated # Units* | Price Per Unit | Estimated Total Cost* | |
TOTAL ADDITIONAL STUDY FEES | 36.414.80 | ||||
M16-047
00152218.1
Price list | ||
Code | Procedure | Budget |
INCON | Subject information and informed consent | 8.70 € |
INCEX | Inclusion/Exclusion criteria | 9.90 € |
T9210 | Medical/Surgical history (includes Drug and Alcohol history at Screening) | 20.10 € |
CONMD | Prior/concomitant therapy | 3.30 € |
S0465 | Latent TB risk factor questionnaire | 2.40 € |
S0910 | Worst Pruritus NRS | 0.00 € |
S0911 | A Derm-SS | 0.90 € |
S0911 | A Derm-IS | 0.90 € |
S0083 | DLQI (Or CDLQI) | 3.00 € |
S0912 | POEM | 0.90 € |
S0667 | HADS | 2.10 € |
S0034 | EQ-5D-5L | 5.10 € |
S0147 | WPAI:AD | 3.30 € |
S0912 | DIS | 0.90 € |
S0558 | SCORA D-Patient Reported & Investigator Assessment | 2.10 € |
S0910 | PGIS | 0.00 € |
S0910 | PGIC | 0.00 € |
S0910 | PGIT | 0.00 € |
99211 | Vital Signs Including Body weight & Height | 7.80 € |
T9207 | Physical Exam | 25.80 € |
S0053 | Xxxxxx staging | 3.60 € |
A DEVT | Adverse Event Assessment | 4.50 € |
S0014 | EASI-Investigator Assessment | 2.70 € |
BSA | BSA-Investigator Assessment | 3.60 € |
S0903 | vIGA-Investigator Assessment | 1.80 € |
T9010 | Urine collection for Central Lab Tests & Urine Pregnancy (If applicable) | 2.10 € |
36415 | Blood draws for Central Lab tests (not including PK Samples) | 3.90 € |
99000 | Lab handling and/or shipping of specimen(s), simple | 3.30 € |
T0299 | Blood samples for Upadacitinib PK assay | 5.70 € |
98966 | Telephone Call | 4.50 € |
NP006 | Pharmacy, Simple- Per Preparation; dispense drug | 3.90 € |
NP030 | Dispense Hand-held ePRO | 5.10 € |
NP021 | Study Coordinator, Simple - Per Visit | 14.40 € |
NP022 | Study Coordinator, Complex - Per Visit | 23.10 € |
NP025 | Physician, Simple - Per Visit | 23.10 € |
NP026 | Physician, Complex - Per Visit | 35.70 € |
NP012 | Study Coordinator, Electronic Data Capture (EDC) - Per Hour | 5.70 € |