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Source text - English The Sponsor shall indemnify and hold harmless, and at the Institution’s request, defend the Institution, its affiliated corporations and its and their respective members, directors, trustees, officers, employees, agents, and all Trial personnel including the Investigator, and their respective approved successors, heirs and assigns (hereinafter referred to as the “Indemnitees”) from and against any damages or other amounts paid or payable by an Indemnitee to a third party (including a participant in the Trial) directly resulting from claims, legal proceedings or causes of actions asserted or initiated or any amounts paid or payable thereunder (collectively, “Claims”) based upon personal injury (including death) to a participant in the Trial, which injury is sustained as a result of the participant’s participation in the Trial and arises directly out of the activities to be carried out pursuant to the protocol for the Trial (the “Protocol”).
Notwithstanding the foregoing, Sponsor shall have no indemnification obligation or liability in relation to any claim or damage resulting from any of the following:
I. The failure of the Investigator or any of the Institution’s employees, agents or other representatives to adhere to the Protocol or the written recommendations and instructions of the Sponsor concerning the administration of NU100, Betaferon® and matching placebo (the “Trial Drug”).
II. The negligent act or omission or willful misconduct or other tort of the Investigator or any of the Institution’s employees, agents or other representatives.
III. The Investigator’s failure to use reasonable medical judgement in the administration, or in control of the administration of the Trial Drug.
IV. The Institution, Investigator and the Indemnitees must have complied with applicable laws, rules and regulations and have conducted the Trial in accordance with the latest applicable Good Clinical Practice.
The Sponsor’s obligation to indemnify and hold harmless is subject to the following conditions:
I. The Institution or the Investigator must promptly provide Sponsor with written notice of any claim or lawsuit involving the Trial Drug and cooperate fully with the Sponsor in the defense thereof, including but not limited to, allowing the Sponsor complete access to all relevant records;
II. The Sponsor retains the right to defend the lawsuit, in any manner it deems appropriate, including the right to retain the counsel of its choice, and if the Sponsor does so, Institution/Investigator cooperate fully in the defense and/or settlement of the same; and
III. The Sponsor has the sole right to settle the claim or lawsuit at its expense.
No party to this Letter of Indemnity shall be liable to any other, for any reason, for any consequential, incidental, special or indirect damages (including loss of profits or business opportunities) regardless of whether such indemnifying party has been advised of or is aware that such damages have been or may be incurred.
This Letter of Indemnity shall be governed by the laws of and the competent courts of shall have jurisdiction.
This Letter of Indemnity shall be effective for the duration of the above mentioned Trial unless it is revoked prior to the end of the Trial.
Translation - Serbian Sponzor će obeštetiti i zaštititi i, na zahtev Institucije, braniti Instituciju, njene pridružene korporacije i njihove odgovarajuće članove, direktore, poverenike, službenike, zaposlene, predstavnike i svo osoblje koje učestvuje u Ispitivanju uključujući Istraživača i njegove odgovarajuće odobrene nastavljače, baštinike i pravne naslednike (dalje u tekstu „Obeštećenici“) za i od svih šteta ili iznosa koje Obeštećenik plati ili treba da plati trećoj strani (uključujući učesnika u Ispitivanju) koji direktno proizilaze iz potvrđenih ili pokrenutih potraživanja, zakonskih postupaka ili uzroka za pokretanje pravnih postupaka ili svih iznosa koji su plaćeni ili naplativi po njima (zajedno: „Potraživanja“) na osnovu lične povrede (uključujući smrt) nanete učesniku Ispitivanja koja je zadobijena kao posledica učešća učesnika u Ispitivanju i proističe direktno iz aktivnosti koje se obavljaju po protokolu Ispitivanja („Protokol“).
Bez obzira na prethodno navedeno, Sponzor neće imati obavezu naknade za obavezu ili dugovanje u vezi sa potraživanjem ili štetom koji su posledica nekog od sledećih slučajeva:
I. Propusta Istraživača ili nekog od zaposlenih Institucije, agenata ili drugih predstavnika da se pridržavaju Protokola ili pisanih preporuka i uputstava Sponzora u vezi sa davanjem leka NU100, Betaferon® i odgovarajućeg placeba (“lek koji se ispituje”).
II. Postupka nemara ili propusta ili namernog nedoličnog ponašanja ili drugog delikta Istraživača ili nekog od zaposlenih, agenata ili drugih predstavnika Institucije.
III. Propusta Istraživača da koristi racionalno medicinsko prosuđivanje u davanju ili kontroli davanja leka koji se ispituje.
IV. Neophodno je da su Institucija, Istraživač i Obeštećenici poštovali važeće zakone, pravila i propise i da su Ispitivanje sproveli u skladu sa najnovijom važećom dobrom kliničkom praksom.
Obaveza Sponzora da obešteti i zaštiti podleže sledećim uslovima:
I. Neophodno je da Institucija ili Istraživač odmah dostave Sponzoru pisano obaveštenje o svakom potraživanju ili sudskom sporu u vezi sa lekom koji se ispituje i da u potpunosti sarađuju sa Sponzorom u njegovoj odbrani, uključujući ali ne ograničavajući se na omogućavanje Sponzoru potpunog pristupa svoj odgovarajućoj evidenciji;
II. Sponzor zadržava pravo odbrane u sudskom sporu na svaki način koji smatra odgovarajućim, uključujući pravo da zadrži branioca po svom izboru, i ako Sponzor to učini, Institucija/Istraživač u potpunosti sarađuju u odbrani i/ili poravnanju spora; i
III. Jedino Sponzor ima pravo na poravnanje potraživanja ili sudskog spora o svom trošku.
Nijedna strana u ovom Pismu o obeštećenju neće imati obavezu prema drugoj strani, iz bilo kog razloga, za bilo kakvu posledičnu, slučajnu, specijalnu ili indirektnu štetu (uključujući gubitak profita ili poslovnih prilika) bez obzira da li je strana koja obeštećuje obaveštena ili svesna da je došlo ili da može doći do takvih šteta.
Ovo Pismo o obeštećenju će se realizovati po zakonima a jurisdikciju će imati sudovi .
Ovo Pismo o obeštećenju će biti na snazi tokom trajanje gorenavedenog Ispitivanja ukoliko ne bude povučeno pre završetka Ispitivanja.
English to Serbian: AMENDMENT No 1 to CLINICAL STUDY AGREEMENT
Source text - English WHEREAS, the Investigator entered into a Clinical Study Agreement on the ………… 2011 with the Company the (“Agreement”);
WHEREAS, the Company has requested an Amendment to the Agreement (“Amendment No 1”);
WHERAS, Sponsor desires to retain the Investigator to perform, and Investigator wishes to perform an Extension Study entitled “A Phase II, double-blind, controlled, multi-center, randomized, long term safety trial of Z102 and Prednisone (5 MG or 7.7 MG) in Patients with Moderate to Severe Rheumatoid Arthritis” (the “Extension Study”) on the terms and conditions set forth in this Amendment No 1.
Whereas, the payment conditions for Screen failures are to be revised to within this Amendment No 1.
NOW THEREFORE, in consideration of the mutual agreements in this Amendment No 1 the Parties hereby agree as follows:
1. A copy of the Extension Study protocol (the “Protocol”), as may be amended from time to time by Sponsor, is appended hereto as Attachment 1 and made a part hereof. The Parties agree that in the event of a conflict between the Protocol and this Amendment No 1, the terms of this Amendment No 1 shall govern, except in the case of matters relating directly to clinical procedures, with respect to which the terms of the Protocol shall prevail.
2. The Parties hereby agree that the Extension Study shall be conducted on the same terms and conditions and with the same representations and warranties set forth in the Agreement for the Study, unless expressly stated otherwise in this Amendment No 1. The rights and obligations and representations and warranties of the Parties under this Amendment No 1 are in addition to those with respect to the Study. Unless expressly stated in this Amendment No 1, the rights and obligations and representations and warranties of the Parties with respect to the Study remain unchanged.
3. The term “Study” within the Agreements shall also include the “Extension Study”.
4. In consideration for performance of the Extension Study by the Investigator, Attachment 2 shall be added to the Agreement.
5. The screen failure text within Appendix 1 shall be replaced with:
“11. The Institution shall receive payment for up to 5 Screen Failures at a rate of [INSERT THE AMOUNT OF THE SCREENING VISIT] Euros per screen failure. Screen failure/enrollment rates will be continually assessed with additional payments for screen failures to be approved by the sponsor in writing.”
6. Except as expressly amended by this Amendment No 1, all other terms and provisions shall remain in full force and effect within the Agreement.
Translation - Serbian BUDUĆI DA JE Istraživač sklopio ugovor o kliničkoj studiji („Ugovor“) sa Kompanijom dana ………… 2011. godine;
BUDUĆI DA JE Kompanija zatražila dopunu Ugovora („Dopuna br. 1”);
BUDUĆI DA Sponzor želi da zadrži Istraživača da sprovede studiju a Istraživač želi da sprovede produženu studiju pod naslovom „Dvostruko slepo, kontrolisano, multicentrično randomizovano dugoročno ispitivanje faze II bezbednosti Z102 i prednizona (5 mg ili 7,7 mg) kod pacijenata sa umerenim do ozbiljnim reumatoidnim artritisom” („Produžena studija”) prema odredbama i uslovima definisanim u ovoj Dopuni br. 1.
Budući da je potrebno da uslovi plaćanja za neuspešni skrining budu izmenjeni u ovoj Dopuni br. 1.
SADA SE, imajući u vidu uzajamne sporazume u ovoj Dopuni br. 1, strane saglašavaju o sledećem:
1. Primerak protokola Produžene studije („Protokol”), koji Sponzor može povremeno dopunjavati, prilaže se ovom Ugovoru kao Prilog 1 i čini njegov sastavni deo. Strane su saglasne da u slučaju konflikta između Protokola i ove Dopune br. 1 prednost imaju odredbe ove Dopune br. 1, izuzev u slučaju pitanja koja se odnose direktno na kliničke procedure, u vezi sa kojima će prednost imati odredbe Protokola.
2. Strane su ovim saglasne da će se Produžena studija sprovoditi prema istim odredbama i uslovima i sa istim izjavama i garancijama definisanim u Ugovoru za Studiju, izuzev gde je u ovoj Dopuni br. 1 izričito navedeno drugačije. Prava i obaveze i izjave i garancije strana po ovoj Dopuni br. 1 dopunjiju one koje važe za Studiju. Ukoliko u ovoj Dopuni br. 1 nije izričito navedeno, prava i obaveze i izjave i garancije Strana u vezi sa Studijom ostaju nepromenjeni.
3. Odredba „Studija” u Ugovorima takođe će uključivati i „Produženu studiju”.
4. Ugovoru će biti dodat Prilog 2 u vezi sa obavljanjem Produžene studije od strane Istraživača.
5. Tekst o neuspešnom skriningu u Dopuni 1 će biti zamenjen sledećim tekstom:
„11. Instituciji će biti plaćeno za najviše 5 neuspešnih skrininga po ceni od [UNETI IZNOS ZA POSETU U CILJU SKRININGA] eura po neuspešnom skriningu. Odnos neuspešnih skrininga/prihvatanja za studiju će se neprekidno procenjivati a sponzor će u pisanom obliku odobravati dodatna plaćanja neuspešnih skrininga.”
6. Izuzev izričitih dopuna iz ove Dopune br. 1, sve ostale odredbe i uslovi u potpunosti ostaju na snazi u okviru Ugovora.
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Graduate diploma - Belgrade University - Faculty of Philology
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Years of experience: 35. Registered at ProZ.com: Aug 2008. Became a member: Oct 2011.
More than 20 years in translation, 18 of which spent as in-house translator of two large Serbian business companies engaged in mechanical and civil engineering and a local TV. Now freelancer with several regular clients in the field of business and financial consulting, manufacturing and engineering, religion, subtitling. Contracts with several international translation agencies and participation in numerous medical, technical, commercial, etc. translation projects.
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