Health Care Laws and Permits. (a) Except as could not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect, each of the Borrower and its Subsidiaries are in compliance with all applicable Health Care Laws. (b) Each of the Borrower and its Subsidiaries holds and is operating in material compliance with all Permits, except where the failure to hold or operate in material compliance with such Permits could not result in a Material Adverse Effect. Neither Borrower nor any of its Subsidiaries has received any written notice of proceedings relating to, and to the knowledge of Borrower there are no facts or circumstances that would reasonably be expected to lead to, the revocation, suspension, termination or modification of any such certificate Permit, except where such revocation, suspension, termination or modification of any such Permit has not had, and could not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect. (c) The Borrower and its Subsidiaries have not received any written notice or, to the knowledge of Borrower, other communication from any Governmental Authority, regarding any actual or alleged violation of, any applicable Health Care Law by Borrower or any of its Subsidiaries, except where such actual or alleged violation has not had, and could not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect. (d) No Included Product is the subject of, or subject to (as applicable), any recall, market withdrawal or seizure, or any warning letter or other written communication from any Governmental Authority to the Borrower or any of its Subsidiaries requiring such action or asserting that an Included Product fails to comply with applicable law, except where such action, letter or communication has not had, and could not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect. Neither Borrower nor any Subsidiary has received written notification from any Governmental Authority that an Included Product fails to comply with applicable Law, which failure would reasonably be expected to result in sanctions or adversely affect the Permits of the Borrower and its Subsidiaries’ facilities, except where such sanctions or adverse effect on the Permits have not had, and could not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect.
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Samples: Credit Agreement (Ani Pharmaceuticals Inc), Credit Agreement (Ani Pharmaceuticals Inc), Credit Agreement (Ani Pharmaceuticals Inc)
Health Care Laws and Permits. (a1) Except as could would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect, each of the Borrower and its Subsidiaries are in compliance with all applicable Health Care Laws.
(b2) Each of the Borrower and its Subsidiaries subsidiaries holds and is operating in material compliance with all Permits, except where the failure to hold or operate in material compliance with such Permits could would not result in a Material Adverse Effect. Neither Borrower nor any of its Subsidiaries has received any written notice of proceedings relating to, and to the knowledge of Borrower there are no facts or circumstances that would could reasonably be expected to lead to, the revocation, suspension, termination or modification of any such certificate Permit, except where such revocation, suspension, termination or modification of any such Permit has not had, and could would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect.
(c3) The Borrower and its Subsidiaries have not received any written notice or, to the knowledge of Borrower, other communication from any Governmental Authority, regarding any actual or alleged violation of, any applicable Health Care Law by Borrower or any of its Subsidiaries, except where such actual or alleged violation has not had, and could would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect.
(d4) No Included Product is the subject of, or subject to (as applicable), any recall, market withdrawal or seizure, or any warning letter or other written communication from any Governmental Authority to the Borrower or any of its Subsidiaries requiring such action or asserting that an Included Product fails to comply with applicable law, except where such action, letter or communication has not had, and could would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect. Neither The Borrower and its Subsidiaries have not received any written notice or written correspondence from any Governmental Authority requiring the termination or suspension of, or imposing a clinical hold on any such studies, tests or preclinical or clinical trials conducted by or on behalf of the Borrower and its Subsidiaries, which termination, suspension or clinical hold would reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect. Since March 9, 2013 neither Borrower nor any Subsidiary has received written notification from any Governmental Authority that an Included Product fails to comply with applicable Law, which failure would could reasonably be expected to result in sanctions or adversely affect the Permits of the Borrower and its Subsidiaries’ facilities, except where such sanctions or adverse effect on the Permits have not had, and could would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect.
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Samples: Credit Agreement (Impax Laboratories Inc), Credit Agreement (Impax Laboratories Inc), Credit Agreement (Impax Laboratories Inc)
Health Care Laws and Permits. (a) Except as could not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect, each of the Lead Borrower and its Restricted Subsidiaries are in compliance with all applicable Health Care Laws.
(b) Each of the Lead Borrower and its Restricted Subsidiaries holds and is operating in material compliance with all Permits, except where the failure to hold or operate in material compliance with such Permits could not result in a Material Adverse Effect. Neither the Lead Borrower nor any of its Restricted Subsidiaries has received any written notice of proceedings relating to, and to the knowledge of each Borrower there are no facts or circumstances that would reasonably be expected to lead to, the revocation, suspension, termination or modification of any such certificate Permit, except where such revocation, suspension, termination or modification of any such Permit has not had, and could not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect.
(c) The Lead Borrower and its Restricted Subsidiaries have not received any written notice or, to the knowledge of BorrowerBorrowers, other communication from any Governmental Authority, regarding any actual or alleged violation of, any applicable Health Care Law by the Lead Borrower or any of its Restricted Subsidiaries, except where such actual or alleged violation has not had, and could not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect.
(d) No Included Product is the subject of, or subject to (as applicable), any recall, market withdrawal or seizure, or any warning letter or other written communication from any Governmental Authority to the Lead Borrower or any of its Restricted Subsidiaries requiring such action or asserting that an Included Product fails to comply with applicable law, except where such action, letter or communication has not had, and could not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect. Neither the Lead Borrower nor any Restricted Subsidiary has received written notification from any Governmental Authority that an Included Product fails to comply with applicable Law, which failure would reasonably be expected to result in sanctions or adversely affect the Permits of the Lead Borrower and its Restricted Subsidiaries’ facilities, except where such sanctions or adverse effect on the Permits have not had, and could not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect.
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