Common use of Food and Drug Laws Clause in Contracts

Food and Drug Laws. (i) Except as otherwise disclosed on Schedule 9.1.29, each Borrower and each Domestic Subsidiary has been and is in compliance in all material respects with all applicable Food and Drug Laws, including federal and state laws, statutes, rules and regulations that relate to the manufacture, handling, transport, management, disposal or sale of pharmaceutical and drug products, including those relating to (i) "good manufacturing practices," "good laboratory practices," "good clinical practices," labeling, record keeping, or filing of reports, or (ii) obligations for products under an Investigational New Drug Application ("INDA"), a New Drug Application ("NDA") or an ANDA except, in each case, to the extent such failure is not reasonably likely to result in a Material Adverse Effect. (ii) Except as otherwise disclosed on Schedule 9.1.29, each Borrower has all material licenses, permits, designations, applications and approvals necessary or required under applicable Food and Drug Laws for the conduct of the business of Borrowers and the Domestic Subsidiaries taken as a whole in its present form, and no material licenses, permits, designations, applications and approvals have been terminated, suspended or revoked, and there are presently no termination, suspension or revocation proceedings, actual, pending, or threatened, in respect thereof, in each case, except to the extent any such termination, suspension or revocation of such material licenses, permits, designations, applications and approvals, individually or in the aggregate, could not reasonably be likely to result in a Material Adverse Effect. (iii) Except as disclosed on Schedule 9.1.29, no Borrower nor any Domestic Subsidiary is the subject of any current or pending investigations, enforcement action or orders, qui tam actions, consent decrees, corporate integrity agreements, settlements, recalls or other extraordinary examinations or review by any Governmental Authority under Food and Drug Laws, that Borrowers believe are reasonably likely to be determined adversely to Borrowers and that if adversely determined to Borrowers would have a Material Adverse Effect. Subject to Section 10.1.13, each Borrower has provided to the Agent true, complete and correct copies of all material notices from the FDA relating to actual investigations, violations or any instances of alleged non-compliance with applicable Food and Drug Laws to the extent Borrowers believe are reasonably likely to be determined adversely to Borrowers and if adversely determined could reasonably result in a Material Adverse Effect.

Food and Drug Laws. (ia) Except as otherwise disclosed on Schedule 9.1.29SCHEDULE 6.28, each Borrower of the Parent Guarantor and each Domestic Subsidiary has been and is in compliance in all material respects with all applicable Food and Drug Laws, including but not limited to federal and state laws, statutes, rules and regulations that relate to the manufacture, handling, transport, management, disposal or sale of pharmaceutical and drug products, including those relating to (i) "good manufacturing practices," "good laboratory practices," "good clinical practices," labeling, record keeping, or filing of reports, or (ii) obligations for products under an Investigational New Drug Application ("INDA"), a New Drug Application ("NDA") or an ANDA except, in each case, to the extent such failure is not reasonably likely to result in a Material Adverse EffectAbbreviated New Drug Application ("ANDA"). (b) SCHEDULE 6.28 sets forth a true and complete list of (i) all licenses, permits, designations, and approvals required and received by any of the Parent Guarantor and/or any Subsidiary pursuant to Food and Drug Laws with respect to any pharmaceutical or drug or other product sold, stored, licensed to or managed by any of the Parent Guarantor and/or any Subsidiary and (ii) Except as otherwise disclosed on Schedule 9.1.29each INDA, NDA, ANDA and analogous foreign application or filing filed or required to be filed by the Parent Guarantor or any Subsidiary and currently pending before the FDA or similar United States or foreign Governmental Authority with respect to any pharmaceutical or drug or other product. Each of the Parent Guarantor and each Borrower Subsidiary has all material licenses, permits, designations, applications and approvals necessary or required under applicable Food and Drug Laws for the conduct of the business of Borrowers the Parent Guarantor and the Domestic Subsidiaries taken as a whole in its present form, and no material licenses, permits, designations, applications and approvals have been terminated, suspended or revoked, and there are presently no termination, suspension or revocation proceedings, actual, pending, or threatened, in respect thereof, in each case, except to the extent any such termination, suspension or revocation of such material licenses, permits, designations, applications and approvals, individually or in the aggregate, could not reasonably be likely to result in a Material Adverse Effectliability to the Parent Guarantor or any Subsidiary in excess of $5,000,000 and, in any event, no such termination, suspension or revocation of any such material licenses, permits, designations, applications and approvals is reasonably likely to have any effect on the Inventory of the Inventory Borrowers or the ability of the Inventory Borrowers to sell such Inventory. (iiic) Except as disclosed on Schedule 9.1.29SCHEDULE 6.28, no Borrower neither the Parent Guarantor nor any Domestic Subsidiary is is, or for the last three years has been, the subject of any current or pending investigations, enforcement action or orders, qui tam QUI TAM actions, consent decrees, corporate integrity agreements, settlements, recalls or other extraordinary examinations or review (i) by any Governmental Authority under Food and Drug Laws, that Borrowers believe are reasonably likely to be determined adversely to Borrowers or (ii) by fiscal intermediaries or carriers under the respective policies and that if adversely determined to Borrowers would have contracts with such fiscal intermediaries or carriers, other than routine audits and inspections conducted on a Material Adverse Effectperiodic basis by such Governmental Authorities, fiscal intermediaries or carriers in the ordinary course of business. Subject to Section 10.1.13, Each of the Parent Guarantor and each Borrower Subsidiary has provided to the Agent true, complete and correct copies of all material notices from correspondence with the FDA or any similar regulatory authority relating to actual or pending investigations, violations or any instances of alleged non-compliance with applicable Food and Drug Laws to the extent Borrowers believe are reasonably likely to be determined adversely to Borrowers and if adversely determined could reasonably result in a Material Adverse EffectLaws.

Food and Drug Laws. (ia) Except as otherwise disclosed on Schedule 9.1.29, each Borrower The Parent Guarantor and each Domestic Subsidiary has been and is shall conduct its business in compliance in all material respects with all Food and Drug Laws applicable to it, including those relating to the manufacture, sale, disposal and transport of pharmaceutical, drug and biological products. The Parent Guarantor and each Subsidiary shall take timely and appropriate action to respond to any notice from the FDA of or any actual knowledge of any material non-compliance by it with Food and Drug Laws and shall regularly (at least quarterly) report to the Agent on such response. (b) Without limiting the generality of the foregoing, the Borrower Parties shall submit to the Agent and the Lenders annually, commencing on the First Anniversary Date, and on each Anniversary Date thereafter, an update of the status of the Parent Guarantor's and the Subsidiaries' compliance with Food and Drug Laws, and any actual or threatened liabilities or actions under such laws. Any notices or allegations of non-compliance, including federal and state lawsa request or order to recall a product, statutes, rules and regulations that relate provided to Parent Guarantor or any Subsidiary shall be forwarded to the manufactureAgent or any Lender within five (5) Business Days of receipt. Upon reasonable request of the Agent or the Lenders, handling, transport, management, disposal or sale of pharmaceutical and drug products, including those relating to (i) "good manufacturing practices," "good laboratory practices," "good clinical practices," labeling, record keeping, or filing of reports, or (ii) obligations for products under an Investigational New Drug Application ("INDA"), a New Drug Application ("NDA") or an ANDA except, in each case, to the extent such failure is not reasonably likely to result in a Material Adverse Effect. (ii) Except as otherwise disclosed on Schedule 9.1.29, each Borrower has Parties shall forward all material licenses, permits, designations, applications and approvals necessary or required under applicable Food and Drug Laws for the conduct of the business of Borrowers and the Domestic Subsidiaries taken as a whole in its present form, and no material licenses, permits, designations, applications and approvals have been terminated, suspended or revoked, and there are presently no termination, suspension or revocation proceedings, actual, pending, or threatened, in respect thereof, in each case, except to the extent any such termination, suspension or revocation of such material licenses, permits, designations, applications and approvals, individually or in the aggregate, could not reasonably be likely to result in a Material Adverse Effect. (iii) Except as disclosed on Schedule 9.1.29, no Borrower nor any Domestic Subsidiary is the subject of any current or pending investigations, enforcement action or orders, qui tam actions, consent decrees, corporate integrity agreements, settlements, recalls or other extraordinary examinations or review by communications with any Governmental Authority under regarding the alleged violation or non-compliance with Food and Drug Laws, that Borrowers believe are reasonably likely to be determined adversely to Borrowers and that if adversely determined to Borrowers would have a Material Adverse Effect. Subject to Section 10.1.13, each Borrower has provided to the Agent true, complete and correct copies Upon receipt of all material notices notice from the FDA relating with respect to actual investigations, violations an alleged violation or any instances of alleged non-compliance with applicable Food and Drug Laws laws (excluding alleged violations with respect to products that have not been launched) or at any time that a Default or Event of Default has occurred and is continuing, the Borrower Parties shall, at the Agent's or the Majority Lenders' reasonable request and at the Borrowers' expense, (i) retain an independent contractor reasonably acceptable to the extent Borrowers believe Agent to evaluate the operations and the alleged violations (excluding alleged violations with respect to products that have not been launched) (it being understood that so long as no Default or Event of Default has occurred and is continuing, any such evaluation of operations shall be limited to the operations that are reasonably likely the subject of the alleged violations), and (ii) prepare and deliver to the Agent, in sufficient quantity for distribution by the Agent to the Lenders, a report setting forth the results of such evaluation, a proposed plan for responding to any potential liabilities described therein, and an estimate of the costs thereof. (c) Upon receipt of notice from the FDA with respect to an alleged violation or non-compliance with Food and Drug laws in all material respects (excluding alleged violations with respect to products that have not been launched) or at any time that a Default or Event of Default has occurred and is continuing, the Agent or its representatives or independent contractors shall have the right at any reasonable time to enter and visit any Real Estate currently owned and/or leased by the Parent Guarantor or any Subsidiary for the purposes of observing the operations and possibly sampling products and product lines of the Parent Guarantor and the Subsidiaries with respect to their compliance with Food and Drug Laws. The Agent is under no duty, however, to undertake such visits, and any such acts by the Agent will be determined adversely to Borrowers solely for the purposes of protecting the Agent's Liens and if adversely determined could reasonably preserving the Agent and the Lenders' rights under the Loan Documents. No site visit, observation or testing by the Agent and the Lenders will result in a Material Adverse Effectwaiver of any Default of the Borrower Parties or impose any liability on the Agent or the Lenders. In no event shall any such site visit or reports therefrom be a representation that the Parent Guarantor or any Subsidiary is in compliance or non-compliance with any Food and Drug Laws. None of the Parent Guarantor, any Subsidiary or any other party is entitled to rely on any site visit, observation or testing by the Agent.

Food and Drug Laws. (i) Except as otherwise disclosed on Schedule 9.1.29, each Each Borrower and each Domestic Subsidiary has been and is shall conduct its business in compliance in all material respects with all applicable Food and Drug Laws, including federal and state laws, statutes, rules and regulations that relate Laws applicable to the manufacture, handling, transport, management, disposal or sale of pharmaceutical and drug productsit, including those relating to (i) "good manufacturing practices," "good laboratory practices," "good clinical practices," labelingthe manufacture, record keepingsale, or filing disposal and transport of reportspharmaceutical, or (ii) obligations for products under an Investigational New Drug Application ("INDA")drug and biological products, a New Drug Application ("NDA") or an ANDA except, in each case, to the extent such failure is except as could not reasonably likely be expected to result in have a Material Adverse Effect. (ii) Except as otherwise disclosed on Schedule 9.1.29, each Borrower has all material licenses, permits, designations, applications and approvals necessary Any notices or required under applicable Food and Drug Laws for the conduct allegations of the business of Borrowers and the Domestic Subsidiaries taken as a whole in its present form, and no material licenses, permits, designations, applications and approvals have been terminated, suspended or revoked, and there are presently no termination, suspension or revocation proceedings, actual, pending, or threatened, in respect thereof, in each case, except to the extent any such termination, suspension or revocation of such material licenses, permits, designations, applications and approvals, individually or in the aggregate, could not reasonably be likely to result in a Material Adverse Effect. (iii) Except as disclosed on Schedule 9.1.29, no Borrower nor any Domestic Subsidiary is the subject of any current or pending investigations, enforcement action or orders, qui tam actions, consent decrees, corporate integrity agreements, settlements, recalls or other extraordinary examinations or review by any Governmental Authority non-compliance under Food and Drug Laws, that Borrowers believe are reasonably likely constituting a request or order to be determined adversely recall a product or to Borrowers and that if adversely determined to Borrowers would have a Material Adverse Effect. Subject to Section 10.1.13curtail manufacturing at its facilities or loss of eligibility for new product approval or other notice of non-compliance outside the Ordinary Course of Business, each Borrower has provided to any Borrower or any Domestic Subsidiary shall be forwarded to Agent or any Lender as soon as possible but no later than thirty (30) days after receipt by a Borrower. Upon the reasonable request of Agent trueor Lenders, complete and correct copies of Borrowers shall forward all material notices from the FDA relating communications to actual investigations, violations any Borrower or any instances of its Domestic Subsidiaries with any Governmental Authority regarding the alleged violation or non-compliance with applicable Food and Drug Laws. Upon receipt of notice from the FDA that any of Borrowers' facilities must curtail manufacturing or is no longer eligible to receive new product approval, Borrowers shall, at Agent's or Required Lenders' reasonable request and at Borrowers' expense, (i) retain an independent contractor reasonably acceptable to Agent to evaluate the operations and the alleged violations (excluding alleged violations with respect to products that have not been launched) (it being understood that so long as no Default or Event of Default has occurred and is continuing, any such evaluation of operations shall be limited to the operations that are the subject of the alleged violations), and (ii) prepare and deliver to Agent, in sufficient quantity for distribution by Agent to Lenders, a report setting forth the results of such evaluation, a proposed plan for responding to any potential liabilities described therein, and an estimate of the costs thereof. (iii) Upon receipt of notice by any Borrower or any of its Domestic Subsidiaries from the FDA with respect to an alleged violation or non-compliance with Food and Drug Laws in all material respects (excluding alleged violations with respect to products that have not been launched) or at any time that a Default or Event of Default has occurred and is continuing, the extent Borrowers believe are reasonably likely Agent or its representatives or independent contractors shall have the right at any reasonable time to be determined adversely to enter and visit any real estate currently owned and/or leased by any Borrower or any Domestic Subsidiary for the purposes of observing and reviewing the operations of Borrowers and if adversely determined could reasonably their Domestic Subsidiaries with respect to their compliance with Food and Drug Laws. Agent is under no duty, however, to undertake such visits, and any such acts by Agent will be solely for the purposes of protecting Agent's Liens and preserving Agent and Lenders' rights under the Loan Documents. No site visit, observation or testing by Agent and Lenders will result in a Material Adverse Effectwaiver of any Default of Borrowers or impose any liability on Agent or Lenders. In no event shall any such site visit or reports therefrom be a representation that any Borrower or any Domestic Subsidiary is in compliance or non-compliance with any Food and Drug Laws. No Borrower, any Domestic Subsidiary nor any other party is entitled to rely on any site visit, observation or testing by Agent.