Insurance 6. 4 Poistenie
a) PSI shall ensure that the Sponsor executes the mandatory clinical trial insurance, as required by the Applicable Regulatory Requirements.
a) PSI zabezpečí, aby Zadávateľ uzatvoril povinné poistenie klinického skúšania podľa Platných právnych predpisov.
Insurance 6. 4 Pojištění
a) PSI shall ensure that the Sponsor executes the mandatory clinical trial insurance in compliance with the § 52 (3f) of the Act No. 378/2007 Coll., on Pharmaceuticals, as amended, as required by the Applicable Regulatory Requirements. a) PSI zajistí, aby Zadavatel uzavřel pojištění klinického hodnocení v souladu s § 52 odst. 3 (f) zákona č. 378/2007 Sb., o léčivech v platném znění, dle Platných regulačních požadavků.
b) The Institution and the Investigator shall subscribe to and maintain all insurances required by the Applicable Regulatory Requirements, including without limitation, liability insurance in compliance with § 45 (2) of the Act No. 372/2011 Coll., on Health Care Services, as amended. They shall provide evidence of such insurance(s) upon request by PSI or the Sponsor.
Insurance 6. 4 Pojištění
a) PSI shall ensure that the Sponsor executes the mandatory clinical trial insurance in compliance with the § 52 (3f) of the Act No. 378/2007 Coll., on Pharmaceuticals, as amended, and as required by the Applicable Regulatory Requirements. A confirmation that insurance has been taken out constitutes a) PSI zajistí, aby Zadavatel uzavřel pojištění klinického hodnocení v souladu s § 52 odst. 3 (f) zákona č. 378/2007 Sb., o léčivech v platném znění a dle Platných regulačních požadavků. Potvrzení o uzavřeném pojištění je Přílohou 5 této Smlouvy.
b) The Institution and the Investigator shall subscribe to and maintain all insurances required by the Applicable Regulatory Requirements, including without limitation, general liability insurance in compliance with Sec. 45 (2) (n) of the Act No. 372/2011 Coll., on Health Care Services, as amended. They shall provide evidence of such insurance(s) upon request by PSI or the Sponsor.
Insurance 6. 4 Poistenie
a) PSI shall ensure that the Sponsor executes the mandatory clinical trial insurance, as required by the Applicable Regulatory Requirements. a) PSI zabezpečí, aby Zadávateľ uzatvoril povinné poistenie klinického skúšania podľa Platných právnych predpisov.
b) The Institution shall subscribe to and maintain adequate medical malpractice, general liability insurance coverage and other appropriate insurance necessary to cover its obligations hereunder, including its indemnification obligations under this Agreement and will provide evidence of such coverage to PSI on request. b) Inštitúcia uzatvorí a bude udržiavať v platnosti adekvátne poistenie pre prípad zanedbania povinnej lekárskej starostlivosti, poistenie všeobecnej zodpovednosti a iné vhodné poistenie nutné v záujme krytia svojich povinností na základe tejto Zmluvy vrátane svojich záväzkov týkajúcich sa odškodnenia vyplývajúcich z tejto Zmluvy a na žiadosť PSI jej poskytne dôkaz o takomto krytí.
Insurance 6. 5 Poistenie
a) The Sponsor shall ensure that the Sponsor executes the mandatory clinical trial insurance in compliance with § 43 (h) of the Act No. 362/2011 Coll. on Pharmaceuticals and Medical Devices, as amended, and as required by the Applicable Regulatory Requirements.
b) The Institution shall subscribe to and maintain all insurances required by the Applicable Regulatory Requirements. They shall provide evidence of such insurance(s) upon request by PSI or the Sponsor.
a) Zadávateľ musí zabezpečiť, aby podpísal povinnú poistnú zmluvu klinického skúšania a to v súlade s § 43 (h) Zákona č. 362/2011 Zb. O liekoch a zdravotníckych pomôckach, v znení neskorších predpisov, a v súlade s platnými legislatívnymi podmienkami.
b) Zdravotnícke zariadenie súhlasí s tým, že podpíše a uchová všetky poistenia, ktoré sú potrebné podľa platných legislatívnych podmienok. Na žiadosť PSI alebo zadávateľa poskytnú dôkaz o tomto(týchto) poistení(iach).
Insurance 6. 4 Poistenie
a) PSI shall ensure that the Sponsor executes the mandatory clinical trial insurance in compliance with the § 43 (h) of the Act No. 362/2011 Coll. on Pharmaceuticals and Medical Devices, as amended, as required by the Applicable Regulatory Requirements. a) PSI zabezpečí, aby Zadávateľ uzavrel povinné poistenie klinického skúšania v súlade s § 43 ods. h) Zákona č. 362/2011 Z. z. o liekoch a zdravotníckych pomôckach v znení neskorších predpisov, v súlade s Platnými právnymi požiadavkami.
b) The Institution and the Investigator shall subscribe to and maintain in full force and effect all insurances required by the Applicable Regulatory Requirements. They shall provide evidence of such insurance(s) upon request by PSI or the Sponsor.
Insurance 6. 4 Pojištění
(a) PSI shall ensure that the Sponsor executes the mandatory clinical trial insurance in compliance with the § 52 (3f) of the Act No. 378/2007 Coll., on Pharmaceuticals, as amended, as required by the Applicable Regulatory Requirements.
(a) PSI zajistí, aby Zadavatel uzavřel pojištění klinického hodnocení v souladu s § 52 odst. 3 (f) zákona č. 378/2007 Sb., o léčivech v platném znění dle Platných regulačních požadavků.
(b) The Institution shall subscribe to and maintain and shall ensure that the Investigator subscribes to and maintains all insurance coverage, as required by law, including without limitation, liability insurance in compliance with § 45 (2) of the Act No. 372/2011 Coll., on Health Care Services, as amended. The Institution shall provide evidence of such insurance upon request by PSI or the Sponsor.
(b) Zdravotnické zařízení uzavře a bude udržovat v platnosti a zajistí, aby Hlavní zkoušející uzavřel a udržoval v platnosti všechna pojištění vyžadována právními předpisy, včetně pojištění odpovědnosti za škodu v souladu s § 45 odst. 2 zákona č. 372/2011 Sb., o zdravotních službách, v platném znění. Zdravotnické zařízení na žádost předloží PSI nebo Zadavateli potvrzení o uzavření tohoto pojištění.
Insurance 6. 7.1 The Companies maintain and have since 1995 maintained insurance of fire, product and general liability, use and occupancy and other forms of insurance covering the Properties and its assets as well as the Business in amounts and against such losses and risks as set out in the Dd-Material, and valid policies for such insurance are now and will be outstanding and duly in force on the Closing <PAGE> Date (but as regards global Perstorp Group policies not thereafter).
Insurance 6. 4. Pojištění a) Sponsor shall obtain clinical trial insurance in compliance with the § 52 (3f) of the Act No. 378/2007 Coll., on Pharmaceuticals, as amended, as required by the Applicable Regulatory Requirements.
a) Zadavatel uzavře pojištění klinického hodnocení v souladu s § 52 (3f) zákona č. 378/2007 Sb. o léčivech, v platném znění a podle platných kontrolních požadavků.
b) The Institution and shall subscribe to and maintain all insurances required by the Applicable Regulatory Requirements, including without limitation, liability insurance in compliance with § 45 (2) of the Act No. 372/2011 Coll., on Health Care Services, as amended . Institution shall provide evidence of such insurance(s) upon request by the Sponsor.
Insurance 6
