Common use of Exclusion Clause in Contracts

Exclusion. Neither any Credit Party nor, to the Knowledge of Parent, any Subsidiary or any officer, Affiliate or employee having authority to act on behalf of any Credit Party or any Subsidiary, is or, to the Knowledge of Parent, has been threatened in writing to be: (i) excluded from any Governmental Payor Program pursuant to 42 U.S.C. § 1320a-7b and related regulations; (ii) “suspended” or “debarred” from selling any products to the U.S. government or its agencies pursuant to the Federal Acquisition Regulation relating to debarment and suspension applicable to federal government agencies generally (42 C.F.R. Subpart 9.4), or other U.S. Requirements of Law; (iii) debarred, disqualified, suspended or excluded from participation in Medicare, Medicaid or any other Governmental Payor Program or is listed on the General Services Administration list of excluded parties; (iv) debarred by the FDA or foreign equivalent; or (v) a party to any other action or proceeding by any Governmental Authority that would prohibit the applicable Credit Party or Subsidiary from distributing or selling any Product in the Territory or providing any services to any governmental or other purchaser pursuant to any Health Care Laws.

Appears in 5 contracts

Samples: Sixteenth Amendment (LumiraDx LTD), Fifteenth Amendment (LumiraDx LTD), Twelfth Amendment and Waiver (LumiraDx LTD)

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Exclusion. Neither any Credit Party nor, to the Knowledge of ParentBorrower, any Subsidiary or any officer, Affiliate or employee having authority to act on behalf of any Credit Party or any Subsidiary, is or, to the Knowledge of ParentBorrower, has been threatened in writing to be: (i) excluded from any Governmental Payor Program pursuant to 42 U.S.C. § 1320a-7b and related regulations; (ii) “suspended” or “debarred” from selling any products to the U.S. government or its agencies pursuant to the Federal Acquisition Regulation relating to debarment and suspension applicable to federal government agencies generally (42 C.F.R. Subpart 9.4), or other U.S. Requirements of Law; (iii) debarred, disqualified, suspended or excluded from participation in Medicare, Medicaid or any other Governmental Payor Program or is listed on the General Services Administration list of excluded parties; or (iv) debarred by the FDA or foreign equivalent; or (v) a party to any other action or proceeding by any Governmental Authority that would prohibit the applicable Credit Party or Subsidiary from distributing or selling any the Product in the Territory or providing any services to any governmental or other purchaser pursuant to any Health Care Laws.

Appears in 3 contracts

Samples: Loan Agreement (Epizyme, Inc.), Loan Agreement (Epizyme, Inc.), Loan Agreement (Biodelivery Sciences International Inc)

Exclusion. Neither any Credit Party nor, to the Knowledge of ParentBorrower, any Subsidiary or any officer, Affiliate or employee having authority to act on behalf of any Credit Party or any Subsidiary, is or, to the Knowledge of ParentBorrower, has been threatened in writing to be: (i) excluded from any Governmental Payor Program pursuant to 42 U.S.C. § 1320a-7b and related regulations; (ii) “suspended” or “debarred” from selling any products to the U.S. government or its agencies pursuant to the Federal Acquisition Regulation relating to debarment and suspension applicable to federal government agencies generally (42 C.F.R. Subpart 9.4), or other U.S. Requirements of Law; (iii) debarred, disqualified, suspended or excluded from participation in Medicare, Medicaid or any other Governmental Payor Program or is listed on the General Services Administration list of excluded parties; (iv) debarred by the FDA or foreign equivalent; or (v) a party to any other action or proceeding by any Governmental Authority that would prohibit the applicable Credit Party or Subsidiary from distributing or selling any Product in the Territory or providing any services to any governmental or other purchaser pursuant to any Health Care Laws; (v) convicted of any crime or, to the Knowledge of Borrower, engaged in any conduct, for which such Person could be debarred, suspended or excluded from participating in any governmental health care program under 42 U.S.C. § 1320a-7 and related regulations or any similar applicable Requirement of Law or program; or (vi) debarred pursuant to 21 U.S.C. § 335a and related regulations.

Appears in 3 contracts

Samples: Loan Agreement, Loan Agreement (Collegium Pharmaceutical, Inc), Loan Agreement (Collegium Pharmaceutical, Inc)

Exclusion. Neither any Credit Party nor, to the Knowledge of ParentBorrower, any Subsidiary or any officer, Affiliate or employee having authority to act on behalf of any Credit Party or any Subsidiary, is or, to the Knowledge of ParentBorrower, has been threatened in writing to be: (i) excluded from any Governmental Payor Program pursuant to 42 U.S.C. § 1320a-7b and related regulations; (ii) “suspended” or “debarred” from selling any products to the U.S. government or its agencies pursuant to the Federal Acquisition Regulation relating to debarment and suspension applicable to federal government agencies generally (42 C.F.R. Subpart 9.4), or other U.S. Requirements of Law; (iii) debarred, disqualified, suspended or excluded from participation in Medicare, Medicaid or any other Governmental Payor Program or is listed on the General Services Administration list of excluded parties; or (iv) debarred by the FDA or foreign equivalent; or (v) a party to any other action or proceeding by any Governmental Authority that would prohibit the applicable Credit Party or Subsidiary from distributing or selling any Product in the Territory or providing any services to any governmental or other purchaser pursuant to any Health Care Laws.

Appears in 3 contracts

Samples: Loan Agreement (Global Blood Therapeutics, Inc.), Loan Agreement (Global Blood Therapeutics, Inc.), Loan Agreement (Sarepta Therapeutics, Inc.)

Exclusion. Neither Except as set forth on Schedule 4.19(k) of the Disclosure Letter, neither any Credit Party nor, to the Knowledge of Parentsuch Credit Party, any Subsidiary or any officer, employee or Affiliate of a Credit Party or employee Subsidiary having authority to act on behalf of any Credit Party or any Subsidiary, is or, to the Knowledge of Parentsuch Credit Party, has been threatened in writing to be: (i) excluded from any Governmental Payor Program pursuant to 42 U.S.C. § 1320a-7b and related regulations, to the extent applicable; (ii) “suspended” or “debarred” from selling any products to the U.S. government or its agencies pursuant to the Federal Acquisition Regulation relating to debarment and suspension applicable to federal government agencies generally (42 C.F.R. Subpart 9.4), or other U.S. Requirements of Law; (iii) debarred, disqualified, suspended or excluded from participation in Medicare, Medicaid or any other Governmental Payor Program or is listed on the General Services Administration list of excluded parties, to the extent applicable; (iv) debarred by the FDA (or foreign equivalent); or (v) a party to any other action or proceeding by any Governmental Authority that would prohibit the applicable Credit Party or Subsidiary from distributing or selling any Product in the Territory or providing any services to any governmental or other purchaser pursuant to any Health Care Laws.

Appears in 2 contracts

Samples: Loan Agreement (Reata Pharmaceuticals Inc), Loan Agreement (INSMED Inc)

Exclusion. Neither Except as set forth on Schedule 4.19(k) of the Disclosure Letter, neither any Credit Party nor, to the Knowledge of Parentsuch Credit Party, any Subsidiary or any officer, Affiliate or employee having authority to act on behalf of any Credit Party or any Subsidiary, is or, to the Knowledge of Parentsuch Credit Party, has been threatened in writing to be: (i) excluded from any Governmental Payor Program pursuant to 42 U.S.C. § 1320a-7b and related regulations, to the extent applicable; (ii) “suspended” or “debarred” from selling any products to the U.S. government or its agencies pursuant to the Federal Acquisition Regulation relating to debarment and suspension applicable to federal government agencies generally (42 C.F.R. Subpart 9.4), or other U.S. Requirements of Law; (iii) debarred, disqualified, suspended or excluded from participation in Medicare, Medicaid or any other Governmental Payor Program or is listed on the General Services Administration list of excluded parties, to the extent applicable; (iv) debarred by the FDA or foreign equivalentFDA; or (v) a party to any other action or proceeding by any Governmental Authority that would prohibit the applicable Credit Party or Subsidiary from distributing or selling any Product in the Territory or providing any services to any governmental or other purchaser pursuant to any Health Care Laws.

Appears in 2 contracts

Samples: Loan Agreement (UroGen Pharma Ltd.), Loan Agreement (UroGen Pharma Ltd.)

Exclusion. Neither any None of the Credit Party norParties or their Subsidiaries, to the Knowledge of Parent, any Subsidiary or nor any officer, Affiliate affiliate, or employee having authority to act on behalf of any Credit Party or any Subsidiaryof its Subsidiaries has been, is or, to the Knowledge of Parentthe applicable Credit Party or Subsidiary, has been threatened in writing to be: , (i) excluded from any Governmental Payor Program pursuant to 42 U.S.C. § 1320a-7b and related regulations; , (ii) “suspended” or “debarred” from selling any products to the U.S. government or its agencies pursuant to the Federal Acquisition Regulation Regulation, relating to debarment and suspension applicable to federal government agencies generally (42 C.F.R. Subpart 9.4), or other U.S. Requirements Requirement of Law; , (iii) debarred, disqualified, suspended or excluded from participation in Medicare, Medicaid or any other Governmental Payor Program health care program or is listed on the General Services Administration list of excluded parties; , nor, to the Knowledge of the applicable Credit Party or Subsidiary, is any such debarment, disqualification, suspension or exclusion threatened or pending, or (iv) debarred by the FDA or foreign equivalent; or (v) made a party part to any other action or proceeding by any Governmental Authority that would may prohibit the applicable Credit Party or Subsidiary from distributing or selling any Product in the Territory Products or providing any services to any governmental or other purchaser pursuant to any Health Care Laws.

Appears in 2 contracts

Samples: Loan Agreement (iRhythm Technologies, Inc.), Loan Agreement (iRhythm Technologies, Inc.)

Exclusion. Neither any Credit Party nor, to the Knowledge of Parentthe Credit Parties, any Subsidiary or any officer, Affiliate or employee having authority to act on behalf of any Credit Party or any Subsidiary, is or, to the Knowledge of Parentthe Credit Parties, has been threatened in writing to be: (i) excluded from any Governmental Payor Program pursuant to 42 U.S.C. § 1320a-7b and related regulations; (ii) “suspended” or “debarred” from selling any products to the U.S. government or its agencies pursuant to the Federal Acquisition Regulation relating to debarment and suspension applicable to federal government agencies generally (42 C.F.R. Subpart 9.4), or other U.S. Requirements of Law; (iii) debarred, disqualified, suspended or excluded from participation in Medicare, Medicaid or any other Governmental Payor Program health care program or is listed on the General Services Administration list of excluded parties; or (iv) debarred by the FDA or foreign equivalent; or (v) a party to any other action or proceeding by any Governmental Authority that would prohibit the applicable Credit Party or Subsidiary from distributing or selling any the Product in the Territory or providing any services to any governmental or other purchaser pursuant to any Health Care Laws.

Appears in 2 contracts

Samples: Loan Agreement (Amicus Therapeutics, Inc.), Loan Agreement (Amicus Therapeutics, Inc.)

Exclusion. Neither any Credit Party norNone of Holdings, to the Knowledge of Parent, any Subsidiary Borrower or any Restricted Subsidiary, nor any owner, officer, Affiliate director, partner, agent, managing employee or employee having authority to act on behalf of Person with a “direct or indirect ownership interest” (as that phrase is defined in 42 C.F.R. § 420.201) in any Credit Party or such entity, nor any SubsidiaryLicensed Personnel, is has been (or, to the Knowledge of Parent, has been threatened in writing to be: ) (i) excluded from any Governmental Payor Program Medicare or Medicaid pursuant to 42 U.S.C. § 1320a-7b 1320a-7 and related regulations; , (ii) “suspended” or “debarred” from selling any products to the U.S. government or its agencies pursuant to the Federal Acquisition Regulation Regulation, relating to debarment and suspension applicable to federal government agencies generally (42 C.F.R. Subpart 9.4), or other U.S. Requirements of Law; applicable laws or regulations, (iii) debarred, disqualified, suspended or excluded from participation in Medicare, from Medicare or Medicaid or any other Governmental Payor Program or is listed on the General Services Administration list of excluded parties; , nor is any such debarment, disqualification, suspension or exclusion threatened or pending, or (iv) debarred by the FDA or foreign equivalent; or (v) made a party to any other action or proceeding by any Governmental Authority that would may prohibit the applicable Credit Party or Subsidiary it from distributing or selling any Product in the Territory products or providing any services to any governmental or other purchaser pursuant to any Health Care Lawsfederal, state or local laws or regulations.

Appears in 2 contracts

Samples: Credit Agreement (GoHealth, Inc.), Credit Agreement (GoHealth, Inc.)

Exclusion. Neither any Credit Party nor, to the Knowledge of ParentBorrower, any Subsidiary or any officer, Affiliate or employee having authority to act on behalf of any Credit Party or any Subsidiary, is or, to the Knowledge of ParentBorrower, has been threatened in writing to be: (i) excluded from any Governmental Payor Program pursuant to 42 U.S.C. § 1320a-7b and related regulations; (ii) “suspended” or “debarred” from selling any products to the U.S. government or its agencies pursuant to the Federal Acquisition Regulation relating to debarment and suspension applicable to federal government agencies generally (42 C.F.R. Subpart 9.4), or other U.S. Requirements of Law; (iii) debarred, disqualified, suspended or excluded from participation in Medicare, Medicaid or any other Governmental Payor Program health care program or is listed on the General Services Administration list of excluded parties; or (iv) debarred by the FDA or foreign equivalent; or (v) a party to any other action or proceeding by any Governmental Authority that would prohibit the applicable Credit Party or Subsidiary from distributing or selling any the Product in the Territory or providing any services to any governmental or other purchaser pursuant to any Health Care Laws.

Appears in 2 contracts

Samples: Loan Agreement, Loan Agreement (Amicus Therapeutics Inc)

Exclusion. Neither any Credit Party nor, to the Knowledge of ParentBorrower, any Subsidiary or any officer, Affiliate or employee having authority to act on behalf of any Credit Party or any Subsidiary, is or, to the Knowledge of ParentBorrower, has been threatened in writing to be: (i) excluded from any Governmental Payor Program pursuant to 42 U.S.C. § 1320a-7b and related regulations, to the extent applicable; (ii) “suspended” or “debarred” from selling any products to the U.S. government or its agencies pursuant to the Federal Acquisition Regulation relating to debarment and suspension applicable to federal government agencies generally (42 C.F.R. Subpart 9.4), or other U.S. Requirements of Law; (iii) debarred, disqualified, suspended or excluded from participation in Medicare, Medicaid or any other Governmental Payor Program or is listed on the General Services Administration list of excluded parties, to the extent applicable; (iv) debarred by the FDA or foreign equivalentFDA; or (v) a party to any other action or proceeding by any Governmental Authority that would prohibit the applicable Credit Party or Subsidiary from distributing or selling any Product in the Territory or providing any services to any governmental or other purchaser pursuant to any Health Care Laws.

Appears in 1 contract

Samples: Loan Agreement (Evolus, Inc.)

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Exclusion. Neither any None of the Credit Party norParties or their Subsidiaries, to the Knowledge of Parent, any Subsidiary or nor any officer, Affiliate affiliate or employee having authority to act on behalf of any Credit Party or any Subsidiaryof its Subsidiaries has been, is or, to the Knowledge of Parenteach Credit Party or any of its Subsidiaries, has been threatened in writing to be: , (i) excluded from any Governmental Payor Program pursuant to 42 U.S.C. § 1320a-7b and related regulations; , (ii) “suspended” or “debarred” from selling any products to the U.S. government or its agencies pursuant to the Federal Acquisition Regulation Regulation, relating to debarment and suspension applicable to federal government agencies generally (42 C.F.R. Subpart 9.4), or other U.S. Requirements of Law; , (iii) debarred, disqualified, suspended or excluded from participation in Medicare, Medicaid or any other Governmental Payor Program health care program or is listed on the General Services Administration list of excluded parties; , nor, to the Knowledge of each Credit Party or any of its Subsidiaries, is any such debarment, disqualification, suspension or exclusion threatened in writing or pending, or (iv) debarred by the FDA or foreign equivalent; or (v) made a party to any other action or proceeding by any Governmental Authority that would may prohibit the applicable Credit Party or Subsidiary from distributing or selling any Product in the Territory Products or providing any services to any governmental or other purchaser pursuant to any Health Care Laws.

Appears in 1 contract

Samples: Loan Agreement (SI-BONE, Inc.)

Exclusion. Neither any None of the Credit Party norParties or their Subsidiaries, to the Knowledge of Parent, any Subsidiary or nor any officer, Affiliate Affiliate, or employee having authority to act on behalf of any Credit Party or any Subsidiaryof its Subsidiaries has been, is or, to the Knowledge of ParentBorrower, has been threatened in writing to be: , (i) excluded from any Governmental Payor Program pursuant to 42 U.S.C. § 1320a-7b and related regulations; , (ii) “suspended” or “debarred” from selling any products to the U.S. government or its agencies pursuant to the Federal Acquisition Regulation Regulation, relating to debarment and suspension applicable to federal government agencies generally (42 C.F.R. Subpart 9.4), or other U.S. Requirements of Law; , (iii) debarred, disqualified, suspended or excluded from participation in Medicare, Medicaid or any other Governmental Payor Program health care program or is listed on the General Services Administration list of excluded parties; , nor, to the Knowledge of Borrower, is any such debarment, disqualification, suspension or exclusion threatened or pending, or (iv) debarred by the FDA or foreign equivalent; or (v) made a party part to any other action or proceeding by any U.S. Governmental Authority that would may prohibit the applicable Credit Party or Subsidiary from distributing or selling any Product Products in the Territory or providing any services to any U.S. governmental or other purchaser pursuant to any Health Care Laws.

Appears in 1 contract

Samples: Loan Agreement (TESARO, Inc.)

Exclusion. Neither any None of the Credit Party norParties or their Subsidiaries, to the Knowledge of Parent, any Subsidiary or nor any officer, Affiliate agent or employee having authority to act on behalf of any Credit Party or any Subsidiaryof its Subsidiaries has been, is or, to the Knowledge of ParentBorrower, has been threatened (unless such threat is frivolous, as reasonably determined in good faith by a Responsible Officer of Borrower) in writing to be: , (i) excluded from any Governmental Payor Program pursuant to 42 U.S.C. § 1320a-7b and related regulations; , (ii) “suspended” or “debarred” from selling any products to the U.S. government or its agencies pursuant to the Federal Acquisition Regulation Regulation, relating to debarment and suspension applicable to federal government agencies generally (42 C.F.R. Subpart 9.4), or other U.S. Requirements of Law; , (iii) debarred, disqualified, suspended or excluded from participation in Medicare, Medicaid or any other Governmental Payor Program health care program or is listed on the General Services Administration list of excluded parties; , nor, to the Knowledge of Borrower, is any such debarment, disqualification, suspension or exclusion threatened or pending, or (iv) debarred by the FDA or foreign equivalent; or (v) made a party part to any other action or proceeding by any Governmental Authority that would may prohibit the applicable Credit Party or Subsidiary from distributing or selling any Product in the Territory Products or providing any services to any governmental or other purchaser pursuant to any Health Care Laws.

Appears in 1 contract

Samples: Loan Agreement (Lexicon Pharmaceuticals, Inc.)

Exclusion. Neither any Credit Party nor, to the Knowledge of Parent, [**] any Subsidiary or any officer, Affiliate or employee having authority to act on behalf of any Credit Party or any Subsidiary, is or, to the Knowledge of ParentBorrower, has been threatened in writing to be: (i) excluded from any Governmental Payor Program pursuant to 42 U.S.C. § 1320a-7b and related regulations; (ii) “suspended” or “debarred” from selling any products to the U.S. government or its agencies pursuant to the Federal Acquisition Regulation relating to debarment and suspension applicable to federal government agencies generally (42 C.F.R. Subpart 9.4), or other U.S. Requirements of Law; (iii) debarred, disqualified, suspended or excluded from participation in Medicare, Medicaid or any other Governmental Payor Program or is listed on the General Services Administration list of excluded parties; or (iv) debarred by the FDA or foreign equivalent; or (v) a party to any other action or proceeding by any Governmental Authority that would prohibit the applicable Credit Party or Subsidiary from distributing or selling any the Product in the Territory or providing any services to any governmental or other purchaser pursuant to any Health Care Laws.

Appears in 1 contract

Samples: Loan Agreement (Akebia Therapeutics, Inc.)

Exclusion. Neither any Credit Party nor, to the Knowledge of Parentthe Credit Parties, any Subsidiary or any officer, Affiliate or employee having authority to act on behalf of any Credit Party or any Subsidiary, is or, to the Knowledge of Parentthe Credit Parties, has been threatened in writing to be: (i) excluded from any Governmental Payor Program pursuant to 42 U.S.C. § 1320a-7b and related regulations; (ii) “suspended” or “debarred” from selling any products to the U.S. government or its agencies pursuant to the Federal Acquisition Regulation relating to debarment and suspension applicable to federal government agencies generally (42 C.F.R. Subpart 9.4), or other U.S. Requirements of Law; (iii) debarred, disqualified, suspended or excluded from participation in Medicare, Medicaid or any other Governmental Payor Program health care program or is listed on the General Services Administration list of excluded parties; or (iv) debarred by the FDA or foreign equivalent; or (v) a party to any other action or proceeding by any Governmental Authority that would prohibit the applicable Credit Party or Subsidiary from distributing or selling any Product in the Territory or providing any services to any governmental or other purchaser pursuant to any Health Care Laws.

Appears in 1 contract

Samples: Loan Agreement (Amicus Therapeutics, Inc.)

Exclusion. Neither Except as set forth on Schedule 4.19(k) of the Disclosure Letter, neither any Credit Party nor, to the Knowledge of ParentBorrower, any Subsidiary or any officer, Affiliate officer or employee or Affiliate of a Credit Party or Subsidiary having authority to act on behalf of any Credit Party or any Subsidiary, is or, to the Knowledge of ParentBorrower, has been threatened in writing to be: (i) excluded from any Governmental Payor Program pursuant to 42 U.S.C. § 1320a-7b and related regulations, to the extent applicable; (ii) “suspended” or “debarred” from selling any products to the U.S. government or its agencies pursuant to the Federal Acquisition Regulation relating to debarment and suspension applicable to federal government agencies generally (42 C.F.R. Subpart 9.4), or other U.S. Requirements of Law; (iii) debarred, disqualified, suspended or excluded from participation in Medicare, Medicaid or any other Governmental Payor Program or is listed on the General Services Administration list of excluded parties, to the extent applicable; (iv) debarred by the FDA (or foreign equivalent); or (v) a party to any other action or proceeding by any Governmental Authority that would prohibit the applicable Credit Party or Subsidiary from distributing or selling any Product in the Territory or providing any services to any governmental or other purchaser pursuant to any Health Care LawsLaws in the Territory.

Appears in 1 contract

Samples: Loan Agreement (ImmunoGen, Inc.)

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