Debarment and Disqualification. Study Site certifies that neither the Study Site, Principal Investigator nor any person directly 16. Vyloučení a diskvalifikace. Studijní pracoviště potvrzuje, že studijní pracoviště, hlavní zkoušející ani xxxx xxxxx xxxxx xxxx employed by them in the performance of the Study has been charged or convicted of a federal or state offense (related to healthcare services or to his/her medical license), debarred or disqualified from participating in clinical research by any regulatory authority for debarment or any similar regulatory action in any country. After execution of this Agreement, if the Study Site becomes aware that the Study Site, Principal Investigator or any employee has been, or is in the process of being charged, convicted, debarred, disqualified or excluded in accordance with the aforementioned provisions, the Study Site hereby certifies it will promptly notify DSI in writing during the term of this Agreement and for three (3) years following its termination or expiration. Study Site also certifies that no debarred or disqualified person will in the future be employed by the Study Site in connection with any work to be performed for or on behalf of DSI (see the FDA Office of Regulatory Affairs Debarment List at xxxx://xxx.xxx.xxx/ora/compliance_ref/debar/) . zaměstnávaná na provádění této studie nebyla obviněna nebo usvědčena z federálního nebo státního trestného činu (v souvislosti se zdravotnickými službami nebo lékařskou licencí) ani jí nebyl uložen zákaz činnosti nebo zákaz účasti na klinickém výzkumu jakýmkoliv regulačním orgánem z důvodu zákazu činnosti nebo podobným regulačním opatřením v kterékoliv zemi. Pokud se studijní pracoviště kdykoliv po podpisu této smlouvy dozví, že dané studijní pracoviště, hlavní zkoušející nebo kterýkoliv zaměstnanec byl xxxx xx obviněn, odsouzen, diskvalifikován, vyloučen nebo xxxxxx zákaz činnosti v souladu s výše uvedenými ustanoveními, studijní pracoviště tímto potvrzuje, že bude okamžitě v tomto smyslu písemně informovat společnost DSI, a to po dobu platnosti této smlouvy a tří (3) let po jejím ukončení či vypršení platnosti. Studijní pracoviště rovněž potvrzuje, že žádná osoba se zákazem výkonu činnosti nebo diskvalifikovaná osoba nebude v budoucnu zaměstnána studijním pracovištěm ve spojitosti s pracemi prováděnými pro společnost DSI nebo jejím jménem (viz seznam osob se zákazem výkonu činnosti vydaný oddělením regulačních záležitostí FDA na adrese xxxx://xxx.xxx.xxx/ora/compliance_ref/debar/) .
Debarment and Disqualification. 13. Vyloučení a zákaz činnosti
Debarment and Disqualification. A. Neither the Group nor any person employed thereby directly in the performance of the Study has been debarred under Section 306(a) or (b) of the Federal Food, Drug and Cosmetic Act and no debarred person will in the future be employed by the Group in connection with any work to be performed for or on behalf of the Company which may later become part of any application for approval of a drug or biologic by the FDA. If at any time after execution of this Agreement, the Group becomes aware that the Group or any person employed thereby is, or is in the process of being, debarred, the Group hereby certifies that the Group will properly notify the Company at once.
Debarment and Disqualification. NST represents that neither it, nor any person employed by NST has ever been debarred, disqualified, or banned under any applicable laws and regulations, including, but not limited to, the Generic Drug Enforcement Act of 1992, 21 C.F.R. section 312.70, and 42 C.F.R. part 1001 et seq. or is under investigation by any regulatory authority, including but not limited to the United States Food and Drug Administration, for debarment, disqualification or any similar regulatory action. NST will immediately notify ACLARIS of any disqualification, debarment or other ban or investigation that comes to its attention.
Debarment and Disqualification. Study Site and Principal Investigator certify that neither the Study Site, Principal Investigator nor any person directly employed by them in the performance of the Study has been charged or convicted of any offense (related to healthcare services or to his/her medical license), debarred or disqualified from participating in clinical research under any applicable laws or by any 16.
Debarment and Disqualification. Study Site and Principal Investigator certify that neither the Study Site, Principal Investigator nor any person directly employed by them in the performance of the Study has been charged or convicted of any offense (related to healthcare services or to his/her medical license), debarred or disqualified from participating in clinical research under any applicable laws or by any regulatory authority, or governmental agency or excluded by any governmental agency from participation in any health care program. After execution of this Agreement, if the Study Site or Principal Investigator become aware that the Study Site, Principal Investigator or any employee has been, or is in the process of being charged, convicted, debarred, disqualified or excluded in accordance with the aforementioned provisions, the Study Site and Principal Investigator hereby certify it will promptly notify DSI in writing during the term of this Agreement and for three (3) years following its termination or expiration. Study Site and Principal Investigator also certify that no debarred or disqualified person will in the future be employed by the Study Site and Principal Investigator in connection with any work to be performed for or on behalf of DSI. 16.
Debarment and Disqualification. The Institution represents and warrants that it nor its Personnel, have ever been (a) debarred, convicted, or subject to a pending debarment or conviction; (b) listed by any government or regulatory agencies as (i) ineligible to participate in any government healthcare programs or government procurement or non- procurement programs, or excluded, debarred, suspended or otherwise made ineligible to participate in any such program, or (ii) disqualified, restricted, or recommended by such government or regulatory agency to be disqualified or restricted from receiving investigational products pursuant to the government or regulatory agency’s regulations; nebo se na něj jinak začnou vztahovat právní kroky, žaloby, nároky, vyšetřování nebo řízení uvedená v článku 13. Xxxxx smluvní strana může tuto smlouvu ukončit v případě, že ji druhá smluvní strana závažným způsobem poruší a nezajistí nápravu do třiceti (30) dnů po obdržení písemného oznámení od smluvní strany, která smlouvu neporušila. Xxxxx smluvní strana má právo tuto smlouvu ukončit okamžitě po písemném oznámení ostatním smluvním stranám, pokud je to nezbytné k ochraně bezpečnosti, zdraví nebo blahobytu subjektů zařazených do studie. V případě ukončení této smlouvy zadavatel poskytovatele zdravotních služeb odškodní (zadavatel samotný nebo prostřednictvím CRO) pouze za ty položky uvedené v příloze B, které vznikly před datem ukončení smlouvy, a přiměřené a nezbytné nezrušitelné výdaje vzniklé před oznámením o ukončení smlouvy a uvedené v příloze B, pokud je to písemně předem schváleno zadavatelem nebo CRO. 12.2. Přetrvání a účinek ukončení. Články 5 až 11 a články 2.8, 2.9, 2.10, 2.11 a 12.2 zůstanou v platnosti i po ukončení nebo vypršení platnosti této smlouvy. V případě ukončení smlouvy podle článku 12.1 výše poskytovatel zdravotních služeb vrátí zadavateli veškeré nezasloužené platby. Navíc budou na žádost zadavatele a na přiměřené náklady zadavatele veškeré studijní materiály vráceny zadavateli. 13.
Debarment and Disqualification. University represents that: (a) neither it, nor any person employed or retained by University who provides any of the Services under this Agreement has been debarred under Section # 306 (a) or (b) of the Federal Food, Drug and Cosmetic Act or disqualified under any applicable law, rule or regulation; (b) that no debarred or disqualified person employed or retained by University in connection with any Service to be performed for or on behalf of Roche; and (c) that if at any time after the execution of this Agreement, University becomes aware that University or any person employed or retained thereby is, or is in the process of being debarred or disqualified, University will promptly notify Roche in writing.
Debarment and Disqualification. Study Site and Principal Investigator certify that neither the Study Site, Principal Investigator nor any person directly employed by them in the performance of the Study has been charged or convicted of any offense (related to healthcare services or to his/her medical license), debarred or disqualified from participating in clinical research under any applicable laws or by any regulatory authority, or governmental agency or excluded by any governmental agency from participation in any health care program. After execution of this Agreement, if the Study Site or Principal Investigator become aware that the Study Site, Principal Investigator or any employee has been, or is in the process of being charged, convicted, debarred, disqualified or excluded in accordance with the aforementioned provisions, the Study Site and Principal Investigator hereby certify it will promptly notify DSI in writing during the term of this Agreement and for three (3) years following its termination or expiration. Study Site and 16.
Debarment and Disqualification. 19.1 The Institution represents and warrants that:
