Debarment and Exclusion. Data User certifies that it is not debarred under subsections 306(a) or (b) of the Federal Food Drug and Cosmetic Act [U.S. Generic Drug Enforcement Act of 1992; 21 USC 335a (a) or (b)], and that it has not and will not use in any capacity the services of any person debarred under such law in performing under this Agreement. Data User further certifies that it is not excluded from any federal health care program, including but not limited to Medicare and Medicaid. Data User will notify Yale immediately if either of these certifications needs to be amended in light of new information.
Debarment and Exclusion. BGM represents and warrants that neither it, nor any of its employees or agents working on the subject matter of this Agreement, has ever been, is currently, or is the subject of a proceeding that could lead to it becoming, as applicable, a Debarred Entity or Individual, an Excluded Entity or Individual or a Convicted Entity or Individual. BGM further covenants, represents and warrants that if, during the Term of this Agreement, it, or any of its employees or agents working on Xxxxxx’x behalf, becomes or is the subject of a proceeding that could lead to that Party becoming, as applicable, a Debarred Entity or Individual, an Excluded Entity or Individual or a Convicted Entity or Individual, BGM shall immediately notify Xxxxxx, and Xxxxxx shall have the right to immediately terminate this Agreement. This provision shall survive termination or expiration of this Agreement. For purposes of this provision, the following definitions shall apply:
Debarment and Exclusion. Each Party represents and warrants that neither such Party, nor any Party employees, agents, subcontractors working on the subject matter hereunder, have ever been, are currently or are the subject of a proceeding that could lead to such Party or such employees, agents or subcontractors becoming, as applicable, a Debarred Entity or Debarred Individual, an Excluded Entity or Excluded Individual or a Convicted Entity or Convicted Individual, nor are they listed on the FDA’s Disqualified/Restricted List. Each Party further covenants, represents and warrants that if, during the Term, Company, or any of Company’s employees, agents or subcontractors working on the subject matter hereunder, becomes or is the subject of a proceeding that could lead to that Party becoming, as applicable, a Debarred Entity or Debarred Individual, an Excluded Entity or Excluded Individual or a Convicted Entity or Convicted Individual, or added to FDA’s Disqualified/Restricted List, such Party will immediately notify the other Party, and such other Party will have the right to immediately terminate this Agreement. This provision will survive termination or expiration of this Agreement. For purposes of this provision, the following definitions will apply: (a) a “Debarred Individual” is 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; (b) a “Debarred Entity” is 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, or a subsidiary or affiliate of a Debarred Entity; (c) an “Excluded Individual” or “Excluded Entity” is (i) an individual or entity, as applicable, who has been excluded, debarred, suspended or is otherwise ineligible to participate in federal health care programs such as Medicare or Medicaid by the Office of the Inspector General (OIG/HHS) of the U.S. Department of Health and Human Services, or (ii) is an individual or entity, as applicable, who has been excluded, debarred, suspended or is otherwise ineligible to participate in federal procurement and non-procurement programs, including those produced by the U.S. General Services Administration (GSA); (d) a “Convicted Individual” or “Convicted Entity” is an individual or entity, as applicable, who has been convicted of a criminal offense t...
Debarment and Exclusion a) Neurocrine represents and warrants that prior to the Effective Date neither it, nor any of its employees, nor […***…] each of its consultants, or independent contractors or any other person working on its behalf that provided services in connection with an NDA for a Product, were at the time the services were performed a Debarred Entity or Debarred Individual, an Excluded Entity or Excluded Individual or a Convicted Entity or Convicted Individual, or after the services were performed, […***…] became a Debarred Entity or Debarred Individual, an Excluded Entity or Excluded Individual or a Convicted Entity or Convicted Individual due to actions related to the services in connection with an NDA for a Product.
b) Neurocrine covenants that with respect to work conducted pursuant to the Transition Plan and Collaborative Development Plan neither it, nor any of its employees, nor […***…] each of its consultants, or independent contractors and any other person working on its behalf that provide services in connection with an NDA for a Product (i) will be at the time services are performed a Debarred Entity or Debarred Individual, an Excluded Entity or Excluded Individual or a Convicted Entity or Convicted Individual or (ii) […***…] are currently the subject of a proceeding that could lead to it or such employees, consultants, independent contractors, becoming, as applicable, a Debarred Entity or Debarred Individual, an Excluded Entity or Excluded Individual or a Convicted Entity or Convicted Individual.
c) Abbott covenants that neither it, nor any of its employees, nor […***…] each of its consultants, or independent contractors or any other person working on its behalf that provide services in connection with an NDA for a Product, (i) will be at the time services are performed a Debarred Entity or Debarred Individual, an Excluded Entity or Excluded Individual or a Convicted Entity or Convicted Individual or (ii) […***…] are currently the subject of a proceeding that could lead to it or such employees, consultants, independent contractors, becoming, as applicable, a Debarred Entity or Debarred Individual, an Excluded Entity or Excluded Individual or a Convicted Entity or Convicted Individual.
d) Each Party covenants, represents and warrants that if, during the Term, it, or any of its employees, consultants, independent contractors, or any other person working on its behalf that provided services or are providing services in connection with an NDA for a Product bec...
Debarment and Exclusion. CoMFRE represents, warrants and covenants that (a) CoMFRE and Principal Investigator are not currently, have never been, and, to the best of CoMFRE’s knowledge, are not the subject of a proceeding that could lead to CoMFRE or Principal Investigator becoming, as applicable, (i) debarred by the FDA under 21 U.S.C. § 335a, (ii) excluded, debarred, suspended, or otherwise ineligible to participate in the Federal health care programs or in Federal procurement or nonprocurement programs, (iii) listed on the FDA’s Disqualified and Restricted Lists for clinical investigators, or (iv) convicted of a criminal offense that falls within the scope of 42 U.S.C. § 1320a-7(a), but has not yet been excluded, debarred, suspended, or otherwise declared ineligible; and (b) CoMFRE shall not engage, directly or indirectly, any person to perform services under this Membership Agreement if that person has ever been, is currently, or, to the best of CoMFRE’s knowledge, is the subject of a proceeding that could lead to that person becoming, as applicable, any of (i)-(iv) above. In the event that CoMFRE receives notice of, or otherwise becomes aware of, the debarment, proposed debarment or such other exclusion, suspension, restriction or sanction of itself, Principal Investigator, or any person providing services in connection with the performance of this Membership Agreement, CoMFRE shall notify Company immediately and Company shall have the right to immediately terminate this Membership Agreement.
Debarment and Exclusion. (a) Each Party hereby represents and warrants that it has not been debarred and is not subject to debarment and that it shall not use in any capacity, in connection with the services to be performed under this Agreement, any Person who has been debarred pursuant to Section 306 of the Act or who is the subject of a conviction described in such section. Each Party shall notify the other Party in writing immediately if it or any of its sales or other Representatives or member of its senior management is debarred or is the subject of a conviction described in Section 306 of the Act, or if any action, suit, claim, investigation, or legal or administrative proceeding is pending or, to the best of that Party’s knowledge, is threatened, relating to the debarment or conviction of that Party or any of its sales or other Representatives or member of that Party’s senior management.
(b) Each Party represents that it has not been nor is it about to be excluded from participation in the federal Medicare or Medicaid program, Maternal and Child Health Services Block Grant, Block Grants for States for Social Services, or State Children’s Health Insurance (collectively, “Federal Health Care Programs”). Either Party agrees to notify the other Party within two (2) business days of receipt of notice of intent to exclude or actual notice of exclusion from any federal Health Care Program. If a Party receives such notice of exclusion or is excluded from any Federal Health Care Program and fails to notify the other Party as described herein, then the Party so failing agrees to indemnify and hold harmless the other Party for any sanctions, penalties, or fines incurred under the Federal Civil Monetary Penalty Law (Section 1128A of the Social Security Act), the Health Insurance Portability and Accountability Act of 1996, or the Balanced Budget Act of 1997, as a result of this Agreement.
Debarment and Exclusion. Abaxis represents and warrants that, to the best of its knowledge, neither it, nor any of its employees or agents providing services under this Agreement, has ever been, is currently, or is the subject of a proceeding that could lead to that Party becoming, as applicable, a Debarred Individual or Debarred Entity. A “Debarred Individual” is an individual who has been debarred by the U.S. Food and Drug Administration (“FDA”) pursuant to Title 00 Xxxxxx Xxxxxx Code §335a (a) or (b), or by any other competent authority, including, without limitation, any local competent authority, from providing services in any capacity to a person that has an approved or pending drug product application. A “Debarred Entity” is a corporation, partnership or association that has been debarred by FDA pursuant to Title 00 Xxxxxx Xxxxxx Code §335a (a) or (b), or by any other competent authority, including, without limitation, any local competent authority, from submitting or assisting in the submission of any abbreviated drug application, or a subsidiary or affiliate of such a corporation, partnership or association. Abaxis further covenants, represents and warrants that if, during the term of this Agreement, it becomes aware that it, or any of its employees or agents providing services under this Agreement, becomes or is the subject of a proceeding that could lead to that Party becoming, as applicable, a Debarred Individual or Debarred Entity, Abaxis shall immediately notify Abbott, and Abbott shall have the right to immediately terminate this Agreement. [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Debarment and Exclusion. Institution represents and warrants that it is not, and it will not engage, directly or indirectly, any person (including, without limitation, the Investigator and subinvestigators) to perform services under this Agreement if that person has ever been, is currently, or, to the best of Institution’s knowledge, is the subject of a proceeding that could lead to that person becoming, as applicable, (a) debarred by the FDA under 21 U.S.C. § 335a or by any other competent authority; (b) excluded, debarred, suspended, or otherwise ineligible to participate in local or U.S. Federal health care programs or in local or U.S. Federal procurement or non- procurement programs; (c) listed on the FDA’s Disqualified and Restricted Lists for clinical investigators; or (d) convicted of a criminal offense that falls within the scope of 42 U.S.C. § 1320a-7(a), or applicable local laws but has not yet been excluded, debarred, suspended, or otherwise declared ineligible. In the event that Institution receives notice of, or otherwise becomes aware of, the debarment, proposed debarment or such other exclusion, suspension, restriction or sanction of itself or any person providing services in connection with the performance of this Agreement, Institution shall notify AbbVie immediately and AbbVie shall have the right to immediately terminate this Agreement. obmedzení alebo sankcii, ktorá sa vzťahuje na ňu alebo niektorú osobu poskytujúcu služby v súvislosti s plnením tejto Zmluvy, okamžite o tom bude informovať spoločnosť AbbVie a spoločnosť AbbVie bude mať právo túto Zmluvu okamžite xxxxxxxxx.
Debarment and Exclusion. Each party represents and warrants that neither it, nor any of its employees or agents working on its behalf and providing items and services pursuant to this Agreement: (i) is currently an Ineligible Person; (ii) has been charged with a criminal offense that falls within the ambit of 42 U.S.C. § 1320a-7(a) or § 1320a-7(b)(l)-(3); or (iii) has been proposed for exclusion, debarment, suspension, or other ineligibility from any Federal health care program or Federal procurement or non-procurement program. Each party further represents and warrants that if, during the term of this Agreement, it or, with respect to any of its employees or agents working on its behalf and providing items and services pursuant to this Agreement, it has actual notice that such employee or agent: (i) becomes an Ineligible Person, (ii) is charged with a criminal offense that falls within the ambit of 42 U.S.C. § 1320a-7(a) or § 1320a-7(b)(l)-(3), or (iii) is proposed for exclusion, debarment, suspension, or other ineligibility from any Federal health care program or Federal procurement or non-procurement program, that party will immediately notify the other party, and such other party will have the right to immediately terminate this Agreement. Vendor agrees to cooperate with any requests for information by CVS in order to screen Vendor’s employees who are providing items and services pursuant to this Agreement to determine if such employees are Ineligible Persons. Each party agrees to indemnify, defend and hold harmless, the other party, its officers, directors, shareholders, employees, agents, representatives, affiliates, and assigns (the “Indemnitees”) from any and all liabilities, losses, claims, damages, obligations, costs, and expenses (including, without limitation, penalties, fines, sanctions, any legal and accounting fees, and expenses, any costs of litigation, investigation, and settlement) that the Indemnitees may incur or suffer as a result of, arising out of, or in any way connected with (i) such party’s negligence or willful act or omission of any of its obligations under this Section, or (ii) breach by such party of any of its representations and warranties contained in this Section. “
Debarment and Exclusion. Except as otherwise specified herein, the Parties’ representations, warranties and covenants with respect to debarment and exclusion in the Collaboration Agreement shall apply to this Agreement mutatis mutandis.
