Debarment and Disqualification. Study Site certifies that neither the Study Site, nor any person directly 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 16. Vyloučení a diskvalifikace. Poskytovatel potvrzuje, že poskytovatel ani žádná osoba jím přímo 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 úřadem similar regulatory action in any country. After execution of this Agreement, if the Study Site becomes aware that the Study Site, 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/) z důvodu zákazu činnosti nebo podobným regulačním opatřením v kterékoliv zemi. Pokud se poskytovatel po uzavření této smlouvy dozví, že daný poskytovatel nebo kterýkoliv zaměstnanec byl nebo je obviněn, odsouzen, diskvalifikován, vyloučen nebo dostal zákaz činnosti v souladu s výše uvedenými ustanoveními, poskytovatel 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. Poskytovatel rovněž potvrzuje, že žádná osoba se zákazem výkonu činnosti nebo diskvalifikovaná osoba nebude v budoucnu zaměstnána poskytovatelem 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. Study Site certifies 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 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/).
Debarment and Disqualification. 13. Vyloučení a zákaz činnosti
13.1. Principal Investigator certifies that he/she is not and has not been debarred, excluded, disqualified or restricted in his/her ability to practice medicine, participate in a clinical trial, or perform services in connection with the evaluation of a pharmaceutical product under any Applicable Laws.
13.1. Hlavní zkoušející potvrzuje, že podle jakýchkoli Platných právních předpisů není a nebyl vyloučen, nebyla mu pozastavena či zakázána činnost, ani mu nebyla omezena lékařská praxe, účast na klinických hodnoceních nebo poskytování služeb v souvislosti s hodnocením farmaceutického produktu.
13.2. Institution and Principal Investigator shall ensure that no Study Staff known to be debarred by any regulatory authority with jurisdiction over the conduct of the Study (including the U.S. Food and Drug Administration) shall participate in the Study.
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.
B. To the Group’s reasonable knowledge, neither the investigator nor any sub-investigator of the Study shall be currently the subject of a disqualification proceeding or have been disqualified by FDA as a clinical investigator pursuant to 21 CFR sec. 312.70, and neither an investigator nor any sub-investigator of the Study shall have entered into an agreement with FDA that in any way restricts their ability to serve as clinical investigators. The Group shall notify the Company immediately upon its knowledge of any inquiry concerning, or the commencement of any such proceeding concerning, an investigator or any sub-investigator.
Debarment and Disqualification. 13. Vyloučení a zákaz činnosti
13.1. Principal Investigator certifies that he/she is not and has not been debarred, excluded, disqualified or restricted in his/her ability to practice medicine, participate in a clinical trial, or perform services in connection with the evaluation of a pharmaceutical product under any Applicable Laws.
13.1. Hlavní zkoušející potvrzuje, že podle jakýchkoli Platných právních předpisů není a nebyl vyloučen, nebyla mu pozastavena či zakázána činnost, ani mu nebyla omezena lékařská praxe, účast na klinických hodnoceních nebo poskytování služeb v souvislosti s hodnocením farmaceutického produktu.
13.2. Institution and Principal Investigator certify that Institution and Principal Investigator have not used and shall not use the services of any person debarred by any regulatory authority with jurisdiction over the conduct of the Study (including the U.S. Food and Drug Administration) in any capacity in connection with the performance of the Study.
13.2. Zdravotnické zařízení a Hlavní zkoušející potvrzují, že nevyužili a nevyužívají služeb žádné osoby, o níž je známo, že jí žádný kontrolní úřad oprávněný dohledem nad prováděním Studie (včetně Úřadu pro kontrolu potravin a léčiv Spojených státu amerických), jednající v jakékoliv funkci v souvislosti s prováděním Studie, zakázal činnost.
13.3. Institution and Principal Investigator shall immediately notify Sponsor or Worldwide, on behalf of Sponsor if any Study Staff becomes debarred or is the subject of a debarment investigation or proceeding at any time during the Study.
Debarment and Disqualification. Institution represents and warrants that it, and its Staff, is not currently:
(i) an individual who has been debarred by the FDA pursuant to 21 U.S.C. § 335a(a) or (b) from providing services in any capacity to a person that has an approved or pending drug product application (a “Debarred Individual”), or an employer, employee, or partner of a Debarred Individual; or
(ii) a corporation, partnership, or association that has been debarred by the FDA pursuant to 21 U.S.C. § 335a(a) or (b) from submitting or assisting in the submission of any abbreviated drug application (a “Debarred Entity”), or an employee, partner, shareholder, member, subsidiary, or affiliate of a Debarred Entity.
(iii) an individual or corporation, partnership, or association that has been barred from participation in a “Federal Health Care Program” (as defined in 42 U.S.C. § 1320a(7b(f)), as amended from time to time or in any other governmental payment program. Institution further represents and certifies that it, and it Staff, including Investigator, have not engaged in any conduct or activity which could lead to any of the above-mentioned disqualifications or debarment actions and that it has no notice that FDA or another regulatory authority intends to seek disqualification or debarment. Institution shall notify Sponsor within ten (10) days of any actual or threatened disqualification, debarment or other ban of the Institution, Investigator or Staff that comes to its attention during the course of the Study.
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. 13. Vyloučení a zákaz činnosti
13.1. Principal Investigator certifies that, as known to the best of his knowledge, he/she is not and has not been debarred, excluded, disqualified, or restricted in his/her ability to practice medicine, participate in a clinical trial, or perform services in connection with the evaluation of a pharmaceutical product under any Applicable Laws.
13.1. Hlavní zkoušející potvrzuje, že, je-li mu podle jeho nejlepšího vědomí známo, podle jakýchkoli Platných právních předpisů není a nebyl vyloučen, nebyla mu pozastavena či zakázána činnost, ani mu nebyla omezena lékařská praxe, účast na klinických hodnoceních nebo poskytování služeb v souvislosti s hodnocením farmaceutického produktu.
13.2. Institution and Principal Investigator shall ensure that no Study Staff known to be debarred by any regulatory authority with jurisdiction over the conduct of the Study (including the U.S. Food and Drug Administration) shall participate in the Study.
Debarment and Disqualification. Supplier represents and warrants to Athenex that neither Supplier nor any of its employees, consultants and agents who will perform any activities in supplying Products to Athenex is debarred, disqualified or involved in any regulatory or misconduct litigation or investigation by any Governmental Authority that might result in any sanction or other disciplinary measures prohibiting or restricting any of them to carry out or participate in such activities. In the event that Supplier becomes aware that any of its employees or agents has any pending proceeding, threatened debarment or disqualifications, it will promptly notify Athenex.
