Common use of Exclusion Clause in Contracts

Exclusion. None of Holdings, the Borrower or any Restricted Subsidiary, nor any owner, officer, director, partner, agent, managing employee or Person with a “direct or indirect ownership interest” (as that phrase is defined in 42 C.F.R. § 420.201) in any such entity, nor any Licensed Personnel, has been (or, has been threatened to be) (i) excluded from Medicare or Medicaid pursuant to 42 U.S.C. § 1320a-7 and related regulations, (ii) “suspended” or “debarred” from selling 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 applicable laws or regulations, (iii) debarred, disqualified, suspended or excluded from participation from Medicare or Medicaid 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) made a party to any other action by any Governmental Authority that may prohibit it from selling products or providing services to any governmental or other purchaser pursuant to any federal, state or local laws or regulations.

Appears in 5 contracts

Sources: Senior Secured Credit Agreement (GoHealth, Inc.), Credit Agreement (GoHealth, Inc.), Credit Agreement (GoHealth, Inc.)

Exclusion. None Neither any Credit Party nor, to the Knowledge of HoldingsParent, the Borrower any Subsidiary or any Restricted officer, Affiliate or employee having authority to act on behalf of any Credit Party or any Subsidiary, nor any owneris or, officer, director, partner, agent, managing employee or Person with a “direct or indirect ownership interest” (as that phrase is defined in 42 C.F.R. § 420.201) in any such entity, nor any Licensed Personnel, has been (orto the Knowledge of Parent, has been threatened in writing to be) : (i) excluded from Medicare or Medicaid any Governmental Payor Program pursuant to 42 U.S.C. § 1320a-7 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 applicable laws or regulations, U.S. Requirements of Law; (iii) debarred, disqualified, suspended or excluded from participation from Medicare in Medicare, Medicaid or Medicaid 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) made debarred by the FDA or foreign equivalent; or (v) a party to any other action or proceeding by any Governmental Authority that may would prohibit it the applicable Credit Party or Subsidiary from distributing or selling products any Product in the Territory or providing any services to any governmental or other purchaser pursuant to any federal, state or local laws or regulationsHealth Care Laws.

Appears in 5 contracts

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

Exclusion. None Neither any Credit Party nor, to the Knowledge of HoldingsBorrower, the Borrower any Subsidiary or any Restricted officer, Affiliate or employee having authority to act on behalf of any Credit Party or any Subsidiary, nor any owneris or, officer, director, partner, agent, managing employee or Person with a “direct or indirect ownership interest” (as that phrase is defined in 42 C.F.R. § 420.201) in any such entity, nor any Licensed Personnel, has been (orto the Knowledge of Borrower, has been threatened in writing to be) : (i) excluded from Medicare or Medicaid any Governmental Payor Program pursuant to 42 U.S.C. § 1320a-7 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 applicable laws or regulations, U.S. Requirements of Law; (iii) debarred, disqualified, suspended or excluded from participation from Medicare in Medicare, Medicaid or Medicaid 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) made a party to any other action or proceeding by any Governmental Authority that may would prohibit it the applicable Credit Party or Subsidiary from distributing or selling products any Product in the Territory or providing any services to any governmental or other purchaser pursuant to any federalHealth Care Laws; (v) convicted of any crime or, state to the Knowledge of Borrower, engaged in any conduct, for which such Person could be debarred, suspended or local laws 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 4 contracts

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

Exclusion. None Neither any Credit Party nor, to the Knowledge of HoldingsBorrower, the Borrower any Subsidiary or any Restricted officer, Affiliate or employee having authority to act on behalf of any Credit Party or any Subsidiary, nor any owneris or, officer, director, partner, agent, managing employee or Person with a “direct or indirect ownership interest” (as that phrase is defined in 42 C.F.R. § 420.201) in any such entity, nor any Licensed Personnel, has been (orto the Knowledge of Borrower, has been threatened in writing to be) : (i) excluded from Medicare or Medicaid any Governmental Payor Program pursuant to 42 U.S.C. § 1320a-7 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 applicable laws or regulations, U.S. Requirements of Law; (iii) debarred, disqualified, suspended or excluded from participation from Medicare in Medicare, Medicaid or Medicaid 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) made a party to any other action or proceeding by any Governmental Authority that may would prohibit it the applicable Credit Party or Subsidiary from distributing or selling products any Product in the Territory or providing any services to any governmental or other purchaser pursuant to any federal, state or local laws or regulationsHealth Care Laws.

Appears in 3 contracts

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

Exclusion. None Neither any Credit Party nor, to the Knowledge of HoldingsBorrower, the Borrower any Subsidiary or any Restricted officer, Affiliate or employee having authority to act on behalf of any Credit Party or any Subsidiary, nor any owneris or, officer, director, partner, agent, managing employee or Person with a “direct or indirect ownership interest” (as that phrase is defined in 42 C.F.R. § 420.201) in any such entity, nor any Licensed Personnel, has been (orto the Knowledge of Borrower, has been threatened in writing to be) : (i) excluded from Medicare or Medicaid any Governmental Payor Program pursuant to 42 U.S.C. § 1320a-7 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 applicable laws or regulations, U.S. Requirements of Law; (iii) debarred, disqualified, suspended or excluded from participation from Medicare in Medicare, Medicaid or Medicaid 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) made a party to any other action or proceeding by any Governmental Authority that may would prohibit it the applicable Credit Party or Subsidiary from distributing or selling products the Product in the Territory or providing any services to any governmental or other purchaser pursuant to any federal, state or local laws or regulationsHealth Care Laws.

Appears in 3 contracts

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

Exclusion. None Except as set forth on Schedule 4.19(k) of Holdingsthe Disclosure Letter, neither any Credit Party nor, to the Borrower Knowledge of such Credit Party, any Subsidiary or any Restricted officer, employee or Affiliate of a Credit Party or Subsidiary having authority to act on behalf of any Credit Party or any Subsidiary, nor any owneris or, officer, director, partner, agent, managing employee or Person with a “direct or indirect ownership interest” (as that phrase is defined in 42 C.F.R. § 420.201) in any to the Knowledge of such entity, nor any Licensed Personnel, has been (orCredit Party, has been threatened in writing to be) : (i) excluded from Medicare or Medicaid any Governmental Payor Program pursuant to 42 U.S.C. § 1320a-7 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, Regulation relating to debarment and suspension applicable to federal government agencies generally (42 C.F.R. Subpart 9.4), or other applicable laws or regulations, U.S. Requirements of Law; (iii) debarred, disqualified, suspended or excluded from participation from Medicare in Medicare, Medicaid or Medicaid 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 to the extent applicable; (iv) made debarred by the FDA (or foreign equivalent); or (v) a party to any other action or proceeding by any Governmental Authority that may would prohibit it the applicable Credit Party or Subsidiary from distributing or selling products Product in the Territory or providing any services to any governmental or other purchaser pursuant to any federal, state or local laws or regulationsHealth Care Laws.

Appears in 3 contracts

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

Exclusion. None Neither any Credit Party nor, to the Knowledge of HoldingsBorrower, the Borrower any Subsidiary or any Restricted officer, Affiliate or employee having authority to act on behalf of any Credit Party or any Subsidiary, nor any owneris or, officer, director, partner, agent, managing employee or Person with a “direct or indirect ownership interest” (as that phrase is defined in 42 C.F.R. § 420.201) in any such entity, nor any Licensed Personnel, has been (orto the Knowledge of Borrower, has been threatened in writing to be) : (i) excluded from Medicare or Medicaid any Governmental Payor Program pursuant to 42 U.S.C. § 1320a-7 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, Regulation relating to debarment and suspension applicable to federal government agencies generally (42 C.F.R. Subpart 9.4), or other applicable laws or regulations, U.S. Requirements of Law; (iii) debarred, disqualified, suspended or excluded from participation from Medicare in Medicare, Medicaid or Medicaid 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 to the extent applicable; (iv) made debarred by the FDA; or (v) a party to any other action or proceeding by any Governmental Authority that may would prohibit it the applicable Credit Party or Subsidiary from distributing or selling products Product in the Territory or providing any services to any governmental or other purchaser pursuant to any federal, state or local laws or regulationsHealth Care Laws.

Appears in 2 contracts

Sources: Loan Agreement (Evolus, Inc.), Loan Agreement (Evolus, Inc.)

Exclusion. None Neither any Credit Party nor, to the Knowledge of HoldingsBorrower, the Borrower any Subsidiary or any Restricted officer, Affiliate or employee having authority to act on behalf of any Credit Party or any Subsidiary, nor any owneris or, officer, director, partner, agent, managing employee or Person with a “direct or indirect ownership interest” (as that phrase is defined in 42 C.F.R. § 420.201) in any such entity, nor any Licensed Personnel, has been (orto the Knowledge of Borrower, has been threatened in writing to be) : (i) excluded from Medicare or Medicaid any Governmental Payor Program pursuant to 42 U.S.C. § 1320a-7 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 applicable laws or regulations, U.S. Requirements of Law; (iii) debarred, disqualified, suspended or excluded from participation from Medicare in Medicare, Medicaid or Medicaid any other health care 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) made a party to any other action or proceeding by any Governmental Authority that may would prohibit it the applicable Credit Party or Subsidiary from distributing or selling products the Product in the Territory or providing any services to any governmental or other purchaser pursuant to any federal, state or local laws or regulationsHealth Care Laws.

Appears in 2 contracts

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

Exclusion. None of Holdings, the Borrower Credit Parties or any Restricted Subsidiarytheir Subsidiaries, nor any owner, officer, directoraffiliate, partneror employee having authority to act on behalf of any Credit Party or any of its Subsidiaries has been, agentor, managing employee to the Knowledge of the applicable Credit Party or Person with a “direct or indirect ownership interest” (as that phrase is defined in 42 C.F.R. § 420.201) in any such entity, nor any Licensed Personnel, has been (orSubsidiary, has been threatened to be) , (i) excluded from Medicare or Medicaid any Governmental Payor Program pursuant to 42 U.S.C. § 1320a-7 1320a-7b and related regulations, (ii) “suspended” or “debarred” from selling 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 applicable laws or regulationsRequirement of Law, (iii) debarred, disqualified, suspended or excluded from participation from Medicare in Medicare, Medicaid or Medicaid any other health care program or is listed on the General Services Administration list of excluded parties, nor nor, to the Knowledge of the applicable Credit Party or Subsidiary, is any such debarment, disqualification, suspension or exclusion threatened or pending, or (iv) made a party part to any other action by any Governmental Authority that may prohibit it the applicable Credit Party or Subsidiary from selling products Products or providing services to any governmental or other purchaser pursuant to any federal, state or local laws or regulationsHealth Care Laws.

Appears in 2 contracts

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

Exclusion. None Neither any Credit Party nor, to the Knowledge of Holdingsthe Credit Parties, the Borrower any Subsidiary or any Restricted officer, Affiliate or employee having authority to act on behalf of any Credit Party or any Subsidiary, nor any owneris or, officer, director, partner, agent, managing employee or Person with a “direct or indirect ownership interest” (as that phrase is defined in 42 C.F.R. § 420.201) in any such entity, nor any Licensed Personnel, has been (orto the Knowledge of the Credit Parties, has been threatened in writing to be) : (i) excluded from Medicare or Medicaid any Governmental Payor Program pursuant to 42 U.S.C. § 1320a-7 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 applicable laws or regulations, U.S. Requirements of Law; (iii) debarred, disqualified, suspended or excluded from participation from Medicare in Medicare, Medicaid or Medicaid any other health care 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) made a party to any other action or proceeding by any Governmental Authority that may would prohibit it the applicable Credit Party or Subsidiary from distributing or selling products the Product in the Territory or providing any services to any governmental or other purchaser pursuant to any federal, state or local laws or regulationsHealth Care Laws.

Appears in 2 contracts

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

Exclusion. None of Holdings, the Borrower Credit Parties or any Restricted Subsidiarytheir Subsidiaries, nor any owner, officer, directoraffiliate or employee having authority to act on behalf of any Credit Party or any of its Subsidiaries has been, partneror, agent, managing employee to the Knowledge of each Credit Party or Person with a “direct or indirect ownership interest” (as that phrase is defined in 42 C.F.R. § 420.201) in any such entity, nor any Licensed Personnel, has been (orof its Subsidiaries, has been threatened in writing to be) , (i) excluded from Medicare or Medicaid any Governmental Payor Program pursuant to 42 U.S.C. § 1320a-7 1320a-7b and related regulations, (ii) “suspended” or “debarred” from selling 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 applicable laws or regulationsRequirements of Law, (iii) debarred, disqualified, suspended or excluded from participation from Medicare in Medicare, Medicaid or Medicaid any other health care program or is listed on the General Services Administration list of excluded parties, nor 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) made a party to any other action by any Governmental Authority that may prohibit it the applicable Credit Party or Subsidiary from selling products Products or providing services to any governmental or other purchaser pursuant to any federal, state or local laws or regulationsHealth Care Laws.

Appears in 1 contract

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

Exclusion. None of Holdings, the Borrower Credit Parties or any Restricted Subsidiarytheir Subsidiaries, nor any owner, officer, directoragent or employee having authority to act on behalf of any Credit Party or any of its Subsidiaries has been, partneror, agent, managing employee or Person with a “direct or indirect ownership interest” (as that phrase is defined in 42 C.F.R. § 420.201) in any such entity, nor any Licensed Personnel, has been (orto the Knowledge of Borrower, 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 Medicare or Medicaid any Governmental Payor Program pursuant to 42 U.S.C. § 1320a-7 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 applicable laws or regulationsRequirements of Law, (iii) debarred, disqualified, suspended or excluded from participation from Medicare in Medicare, Medicaid or Medicaid any other health care program or is listed on the General Services Administration list of excluded parties, nor nor, to the Knowledge of Borrower, is any such debarment, disqualification, suspension or exclusion threatened or pending, or (iv) made a party part to any other action by any Governmental Authority that may prohibit it the applicable Credit Party or Subsidiary from selling products any Products or providing any services to any governmental or other purchaser pursuant to any federal, state or local laws or regulationsHealth Care Laws.

Appears in 1 contract

Sources: Loan Agreement (Lexicon Pharmaceuticals, Inc.)

Exclusion. None of Holdings, the Borrower or Neither any Restricted Credit Party nor any Subsidiary, nor to the Knowledge of the Credit Parties, any owner, officer, directorAffiliate or employee having authority to act on behalf of any Credit Party or any Subsidiary, partner, agent, managing employee is or Person with a “direct or indirect ownership interest” (as that phrase is defined in 42 C.F.R. § 420.201) in any such entity, nor any Licensed Personnel, has been (or, has been threatened in writing to be) : (i) excluded from Medicare or Medicaid any Governmental Payor Program pursuant to 42 U.S.C. § 1320a-7 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 applicable laws or regulations, U.S. Requirements of Law; (iii) debarred, disqualified, suspended or excluded from participation from Medicare in Medicare, Medicaid or Medicaid any other health care 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) made a party to any other action or proceeding by any Governmental Authority that may would prohibit it the applicable Credit Party or Subsidiary from distributing or selling products any Product in the Territory or providing any services to any governmental or other purchaser pursuant to any federal, state or local laws or regulationsHealth Care Laws.

Appears in 1 contract

Sources: Loan Agreement (Axsome Therapeutics, Inc.)

Exclusion. None Except as set forth on Schedule 4.19(k) of Holdingsthe Disclosure Letter, neither any Credit Party nor, to the Borrower Knowledge of Borrower, any Subsidiary or any Restricted officer or employee or Affiliate of a Credit Party or Subsidiary having authority to act on behalf of any Credit Party or any Subsidiary, nor any owneris or, officer, director, partner, agent, managing employee or Person with a “direct or indirect ownership interest” (as that phrase is defined in 42 C.F.R. § 420.201) in any such entity, nor any Licensed Personnel, has been (orto the Knowledge of Borrower, has been threatened in writing to be) : (i) excluded from Medicare or Medicaid any Governmental Payor Program pursuant to 42 U.S.C. § 1320a-7 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, Regulation relating to debarment and suspension applicable to federal government agencies generally (42 C.F.R. Subpart 9.4), or other applicable laws or regulations, U.S. Requirements of Law; (iii) debarred, disqualified, suspended or excluded from participation from Medicare in Medicare, Medicaid or Medicaid 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 to the extent applicable; (iv) made debarred by the FDA (or foreign equivalent); or (v) a party to any other action or proceeding by any Governmental Authority that may would prohibit it the applicable Credit Party or Subsidiary from distributing or selling products Product in the Territory or providing any services to any governmental or other purchaser pursuant to any federal, state or local laws or regulationsHealth Care Laws in the Territory.

Appears in 1 contract

Sources: Loan Agreement (ImmunoGen, Inc.)

Exclusion. None of Holdings, the Borrower Credit Parties or any Restricted Subsidiarytheir Subsidiaries, nor any owner, officer, directorAffiliate, partneror employee having authority to act on behalf of any Credit Party or any of its Subsidiaries has been, agentor, managing employee or Person with a “direct or indirect ownership interest” (as that phrase is defined in 42 C.F.R. § 420.201) in any such entity, nor any Licensed Personnel, has been (orto the Knowledge of Borrower, has been threatened in writing to be) , (i) excluded from Medicare or Medicaid any Governmental Payor Program pursuant to 42 U.S.C. § 1320a-7 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 applicable laws or regulationsU.S. Requirements of Law, (iii) debarred, disqualified, suspended or excluded from participation from Medicare in Medicare, Medicaid or Medicaid any other health care program or is listed on the General Services Administration list of excluded parties, nor nor, to the Knowledge of Borrower, is any such debarment, disqualification, suspension or exclusion threatened or pending, or (iv) made a party part to any other action by any U.S. Governmental Authority that may prohibit it the applicable Credit Party or Subsidiary from distributing or selling products any Products in the Territory or providing any services to any U.S. governmental or other purchaser pursuant to any federal, state or local laws or regulationsHealth Care Laws.

Appears in 1 contract

Sources: Loan Agreement (TESARO, Inc.)

Exclusion. None of Holdings, the Borrower Neither any Credit Party [**] any Subsidiary or any Restricted officer, Affiliate or employee having authority to act on behalf of any Credit Party or any Subsidiary, nor any owneris or, officer, director, partner, agent, managing employee or Person with a “direct or indirect ownership interest” (as that phrase is defined in 42 C.F.R. § 420.201) in any such entity, nor any Licensed Personnel, has been (orto the Knowledge of Borrower, has been threatened in writing to be) : (i) excluded from Medicare or Medicaid any Governmental Payor Program pursuant to 42 U.S.C. § 1320a-7 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 applicable laws or regulations, U.S. Requirements of Law; (iii) debarred, disqualified, suspended or excluded from participation from Medicare in Medicare, Medicaid or Medicaid 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) made a party to any other action or proceeding by any Governmental Authority that may would prohibit it the applicable Credit Party or Subsidiary from distributing or selling products the Product in the Territory or providing any services to any governmental or other purchaser pursuant to any federal, state or local laws or regulationsHealth Care Laws.

Appears in 1 contract

Sources: Loan Agreement (Akebia Therapeutics, Inc.)

Exclusion. None Neither any Credit Party nor, to the Knowledge of Holdingsthe Credit Parties, the Borrower any Subsidiary or any Restricted officer, Affiliate or employee having authority to act on behalf of any Credit Party or any Subsidiary, nor any owneris or, officer, director, partner, agent, managing employee or Person with a “direct or indirect ownership interest” (as that phrase is defined in 42 C.F.R. § 420.201) in any such entity, nor any Licensed Personnel, has been (orto the Knowledge of the Credit Parties, has been threatened in writing to be) : (i) excluded from Medicare or Medicaid any Governmental Payor Program pursuant to 42 U.S.C. § 1320a-7 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 applicable laws or regulations, U.S. Requirements of Law; (iii) debarred, disqualified, suspended or excluded from participation from Medicare in Medicare, Medicaid or Medicaid any other health care 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) made a party to any other action or proceeding by any Governmental Authority that may would prohibit it the applicable Credit Party or Subsidiary from distributing or selling products any Product in the Territory or providing any services to any governmental or other purchaser pursuant to any federal, state or local laws or regulationsHealth Care Laws.

Appears in 1 contract

Sources: Loan Agreement (Amicus Therapeutics, Inc.)