Common use of Debarment and Exclusion Clause in Contracts

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 that falls within the ambit of 42 U.S.C. §1320a — 7(a), but has not yet been excluded, debarred, suspended or otherwise declared ineligible; and (e) “FDA’s Disqualified/Restricted List” is the list of clinical investigators restricted from receiving investigational drugs, biologics, or devices if FDA has determined that the investigators have repeatedly or deliberately failed to comply with regulatory requirements for studies or have submitted false information to the study sponsor. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

Debarment and Exclusion. Each Party 28.1 XXXX represents and warrants that neither such Partyit, nor any Party employees, agents, subcontractors of its employees or agents working on the subject matter hereunderIMPAX’s behalf, have has ever been, are currently is currently, or are is the subject of a proceeding that could lead to such Party or such employees, agents or subcontractors that party 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 XXXX further covenants, represents and warrants that if, during the Termterm of this Agreement, Companyit, or any of Company’s employees, its employees or agents or subcontractors working on the subject matter hereunderIMPAX’s behalf, becomes or is the subject of a proceeding that could lead to that Party 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 XXXX shall immediately notify the other PartyIMPAX, and such other Party will IMPAX shall have the right to immediately terminate this AgreementAgreement upon written notice. This provision will shall 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 provided 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; subsections (c) an “Excluded Individual” through (f) shall apply. 28.2 IMPAX represents and warrants that neither it, nor any of its employees or “Excluded Entity” agents working on DAVA’s behalf, has ever been, is (i) an individual currently, or entityis the subject of a proceeding that could lead to that party becoming, as applicable, who has been excludeda Debarred Entity or Individual, debarredan Excluded Entity or Individual or a Convicted Entity or Individual. IMPAX further covenants, suspended represents and warrants that if, during the term of this Agreement, it, or any of its employees or agents working on DAVA’s behalf, becomes or is otherwise ineligible the subject of a proceeding that could lead 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 entitythat party becoming, as applicable, who has been excludeda Debarred Entity or Individual, debarredan Excluded Entity or Individual or a Convicted Entity or Individual, suspended IMPAX shall immediately notify XXXX, and XXXX shall have the right to immediately terminate this Agreement upon written notice. This provision shall survive termination or is otherwise ineligible to participate expiration of this Agreement. For purposes of this provision, the definitions provided in federal procurement and non-procurement programs, including those produced by the U.S. General Services Administration subsections (GSA); c) thorugh (df) a “Convicted Individual” or “Convicted Entity” is an individual or entity, as applicable, who has been convicted of a criminal offense that falls within the ambit of 42 U.S.C. §1320a — 7(a), but has not yet been excluded, debarred, suspended or otherwise declared ineligible; and (e) “FDA’s Disqualified/Restricted List” is the list of clinical investigators restricted from receiving investigational drugs, biologics, or devices if FDA has determined that the investigators have repeatedly or deliberately failed to comply with regulatory requirements for studies or have submitted false information to the study sponsor. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSIONshall apply.

Debarment and Exclusion. Each Party represents and warrants that to the best of its knowledge as of the Effective Date neither such Partyit, nor any Party employees, agents, subcontractors of its employees or agents working on the subject matter hereunderof this Agreement, have has ever been, are currently is currently, or are is the subject of a proceeding that could lead to such Party or such employees, agents or subcontractors it 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 ListList for clinical investigators. Each Party further covenants, represents and warrants that if, during the Term, Companyit, or any of Company’s employees, its employees or agents or subcontractors working on the subject matter hereundertheir behalf, becomes or is the subject of a proceeding that could lead to that Party with respect to the subject matter hereof, 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 ListList for clinical investigators, such Party will shall immediately notify the other Party, and the Parties shall undertake discussions with respect to such other Party will have the right to immediately terminate this Agreementnotification. This provision will shall survive termination or expiration of this Agreement. For purposes of this provision, the following definitions will shall apply: (a) a : 10.2.1 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 . 10.2.2 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 Affiliate of a Debarred Entity; (c) an . 10.2.3 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 . 10.2.4 A “Convicted Individual” or “Convicted Entity” is an individual or entity, as applicable, who has been convicted of a criminal offense that falls within the ambit of 42 U.S.C. §1320a — – 7(a), but has not yet been excluded, debarred, suspended or otherwise declared ineligible; and (e) . 10.2.5 “FDA’s Disqualified/Restricted List” is the list of clinical investigators restricted from receiving investigational drugs, biologics, biologics or devices if FDA has determined that the investigators have repeatedly or deliberately failed to comply with regulatory requirements for studies or have submitted false information to the study sponsor. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

Debarment and Exclusion. Each Party (a) Hospital represents and warrants that neither such Partynone of Hospital, nor any Party Hospital employees, agents, agents and subcontractors working on the subject matter performing hereunder, have ever been, are currently currently, or are the subject of a proceeding that could lead to such Party Hospital 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 ListList for clinical investigators. Each Party Hospital further covenants, represents and warrants that if, during the Term, CompanyHospital, or any of CompanyHospital’s employees, agents or subcontractors working on the subject matter subcontractors, performing hereunder, becomes or is the subject of a proceeding that could lead to that Party 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 ListList for clinical investigators, such Party Hospital will immediately notify the other PartySponsor, and such other Party Sponsor will have the right to immediately terminate this Agreement. This provision will survive termination or expiration of this Agreement. (b) Sponsor hereby certifies that as of October, 2010, it has not been, and their principals have not been, debarred under the provisions of the Generic Drug Enforcement Act of 1992, 21 U.S.C. §335a(a) and (b), or sanctioned by a Federal Health Care Program (as defined in 42 U.S.C. Sec. 1320 a-7b(f)), including, but not limited to the federal Medicare or a state Medicaid program, or debarred, suspended, excluded or otherwise declared ineligible from any Federal agency or program. In the event that during the term of this Agreement, Sponsor (i) becomes Debarred, suspended, Excluded, sanctioned, or otherwise declared ineligible; or (ii) receives notice of an action or threat of an action with respect to any such debarment, suspension, exclusion, sanction, or ineligibility, Sponsor shall immediately notify Hospital. Sponsor also agrees that, in the event that either it or its principals becomes Debarred, suspended, Excluded, sanctioned, or otherwise declared ineligible, Sponsor shall immediately notify the Hospital. (c) 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 that falls within the ambit of 42 U.S.C. §1320a — 7(a), but has not yet been excluded, debarred, suspended or otherwise declared ineligible; and (e) “FDA’s Disqualified/Restricted List” is the list of clinical investigators restricted from receiving investigational drugs, biologics, or devices if FDA has determined that the investigators have repeatedly or deliberately failed to comply with regulatory requirements for studies or have submitted false information to the study sponsor. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION: