Debarred. Neither ELITE nor any of its officers, directors, or employees or consultants performing services under this Agreement has been or is: (1) an individual who has been debarred by the FDA pursuant to 21 U.S.C. § 335a(a) or (b) (“Debarred Individual”) from providing services in any capacity to a person that has an approved or pending drug product application with FDA, or an employer, employee, or partner of such a Debarred Individual; or (2) a corporation, partnership or association that has been debarred by FDA pursuant to 21 U.S.C. § 335a(a) or (b) (“Debarred Entity”) from submitting or assisting in the submission of an ANDA, or an employee, partner, shareholder, member, subsidiary, or affiliate of a Debarred Entity; or (3) an employer, employee or partner of an individual convicted within the last five years for crimes described in subsections (a) or (b) of Section 306 of the FDCA. If and when ELITE becomes aware of any fact that makes or gives rise to make this representation and warranty untrue, ELITE shall immediately notify LANNETT in writing and any such breach may result in immediate termination of this Agreement by LANNETT.
Debarred. Neither LANNETT nor any of its officers, directors, or employees or consultants performing services under this Agreement has been or is: (1) a Debarred Individual or an employer, employee, or partner of such a Debarred Individual; or (2) a Debarred Entity, or an employee, partner, shareholder, member, subsidiary, or affiliate of a Debarred Entity; or (3) an employer, employee or partner of an individual convicted within the last five years for crimes described in subsections (a) or (b) of Section 306 of the FDCA. If and when LXXXXXX becomes aware of any fact that makes or gives rise to make this representation and warranty untrue, LXXXXXX shall immediately notify ELITE in writing and any such breach may result in immediate termination of this Agreement by ELITE. EXPLANATORY NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED
Debarred. NeoGenesis certifies that it is not debarred under 21 USC 335(a) or (b) of the Federal Food, Drug, and Cosmetic Act and that it has not used and will not use in any capacity the services of any Person debarred under such laws with respect to services to be performed under the Agreement.
Debarred. Has your company ever been debarred or suspended for doing business with the City of Lincoln/Lancaster County/PBC of Nebraska no
Debarred. As detailed on the attached explanation (Bidder to provide), Bidder and/or its principals presently are debarred, suspended, proposed for debarment, declared ineligible, or voluntarily excluded from contracting with a federal, state, or local governmental entity. Criminal Offense. Bidder certifies as follows (must check one): No Criminal Offense. Bidder has not, within the three (3) year period preceding the date of this Competitive Solicitation, been convicted or had a civil judgment rendered against Bidder for commission of fraud or a criminal offense in connection with obtaining, attempting to obtain, or performing a governmental contract; violation of any federal or state antitrust statute; or commission of embezzlement, theft, forgery, bribery, falsification or destruction of records, making false statements, or receiving stolen property. Xxxxxx further certifies that it is not presently indicted or otherwise criminally or civilly charged by a governmental entity with commission of any of the offenses enumerated in this paragraph. or
Debarred. During the Transition Term, Momenta shall not become, and shall not use a Subcontractor for the Transition Services, a Person who has been (i) debarred under the U.S. Generic Drug Enforcement Act, 21 USC §335a(k)(1) or (ii) convicted of a crime as defined under the U. S. Generic Drug Enforcement Act.
Debarred. Neither ELITE nor any of its officers, directors, or employees or consultants performing services under this Agreement has been or is: (1) an individual who has been debarred by the FDA pursuant to 21 U.S.C. § 335a(a) or (b) (“Debarred Individual”) from providing services in any capacity to a person that has an approved or pending drug product application with FDA, or an employer, employee, or partner of such a Debarred Individual; or (2) a corporation, partnership or association that has been debarred by FDA pursuant to 21 U.S.C. § 335a(a) or (b) (“Debarred Entity”) from submitting or assisting in the submission of an ANDA, or an employee, partner, shareholder, member, subsidiary, or affiliate of a Debarred Entity; or (3) an employer, employee or partner of an individual convicted within the last five years for crimes described in subsections (a) or (b) of Section 306 of the FDCA. If and when ELITE becomes aware of any fact that makes or gives rise to make this representation and warranty untrue, ELITE shall immediately notify LXXXXXX in writing and any such breach may result in immediate termination of this Agreement by LXXXXXX. EXPLANATORY NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED
Debarred. Neither LANNETT nor any of its officers, directors, or employees or consultants performing services under this Agreement has been or is: (1) a Debarred Individual or an employer, employee, or partner of such a Debarred Individual; or (2) a Debarred Entity, or an employee, partner, shareholder, member, subsidiary, or affiliate of a Debarred Entity; or (3) an employer, employee or partner of an individual convicted within the last five years for crimes described in subsections (a) or (b) of Section 306 of the FDCA. If and when LANNETT becomes aware of any fact that makes or gives rise to make this representation and warranty untrue, LANNETT shall immediately notify ELITE in writing and any such breach may result in immediate termination of this Agreement by ELITE.
Debarred. Neither GLENMARK nor any of its officers, directors, or employees or consultants performing services under this Agreement has been or is: (1) a Debarred Individual or an employer, employee, or partner of such a Debarred Individual; or (2) a Debarred Entity, or an employee, partner, shareholder, member, subsidiary, or affiliate of a Debarred Entity; or (3) an employer, employee or partner of an individual convicted within the last five years for crimes described in subsections (a) or (b) of Section 306 of the FDCA. If and when GLENMARK becomes aware of any fact that makes or gives rise to make this representation and warranty untrue, GLENMARK shall immediately notify ELITE in writing and any such breach may result in immediate termination of this Agreement by ELITE.
Debarred. ARx has never been and is not currently: (1) an individual who has been debarred by the FDA pursuant to 21 U.S.C. § 335a(a) or (b) (“Debarred Individual”)from providing services in any capacity to a person that has an approved or pending drug product application with FDA, or an employer, employee, or partner of such a Debarred Individual; or (2) a corporation, partnership or association that has been debarred by FDA pursuant to 21 U.S.C. § 335a(a) or (b) (“Debarred Entity”)from submitting or assisting in the submission of an NDA, or an employee, partner, shareholder, member, subsidiary, or affiliate of a Debarred Entity, or (3) an employer, employee or partner of an individual convicted within the last five years for crimes described in subsections (a) or (b) of Section 306(i) of the Food Drug and Cosmetic Act. ARx further represents that: (4) ARx has no knowledge of any circumstances which may affect the accuracy of the foregoing representation, including, without limitation, any FDA investigations of, or debarment proceedings against, ARx or any person or entity performing services or rendering assistance which is in any way related to activities taken pursuant to this Agreement; and (5) ARx will immediately notify Cynapsus in writing, by certified or registered mail if ARx, at any time during the term of this Agreement, becomes aware of any such circumstances described in this Article 10.2(c).
