Food and Drug. Except as could not reasonably be expected to result in a Material Adverse Effect, the Company and/or its Subsidiaries have all requisite permits, licenses, and approvals that are required under the Laws of the United States Food and Drug Administration (the “FDA”) (the “FDA Laws”) for the operation of the business of the Company and its Subsidiaries (collectively, the “FDA Permits”) and such FDA Permits (a) are valid and in full force and effect, (b) have not been reversed, stayed, set aside, annulled, or suspended and (c) are not subject to any conditions or requirements that are not generally imposed on the holders thereof. The Company and/or its Subsidiaries are in compliance with all applicable FDA Laws, including, without limitation, current good manufacturing practice requirements except as could not reasonably be expected to result in a Material Adverse Effect.
Food and Drug. 12 s. Fair Consideration; No Fraudulent Conveyance.............. 13 t.
Food and Drug. Seller and all of its products have been at ------------- all times and continue to be in compliance with the Food, Drug and Cosmetic Act (the "Act") and all regulations promulgated thereunder by the United States Food --- and Drug Administration ("FDA") and equivalent foreign agencies except to the --- extent that noncompliance would not have a material adverse effect on Seller's business or the Purchased Assets. Without limitation on the foregoing representation and warranty, Seller further represents and warrants as follows, in each case except where the failure would not have a material adverse effect on the Purchased Assets or the Business:
Food and Drug. Wherever applicable, the Seller and all of its products have been at all times and continue to be in compliance with the Food, Drug and Cosmetic Act (the "FDC ACT") and the Public Health Service Act ("PHS ACT") and all regulations promulgated thereunder by the United States Food and Drug Administration ("FDA") and equivalent foreign agencies except to the extent that noncompliance would not have a material adverse effect upon the Business. Without limitation on the foregoing representation and warranty, the Seller further represents and warrants as follows:
Food and Drug. Set forth on Schedule 5.1(hh) is a correct and complete list of (i) all permits, licenses and approvals that are required under the FDA Laws for the operation of the Loan Parties’ business (collectively, the “FDA Permits”). Each Loan Party has all applicable FDA Permits, all of which (A) are valid and in full force and effect, (B) have not been reversed, stayed, set aside, annulled or suspended, (C) are not subject to any conditions or requirements that are not generally imposed on the holders thereof, and (iii) constitute the only licenses, permits, authorizations, consents and approvals required from FDA for the operation of the Loan Party’s business as currently conducted and as contemplated in the Purchase Documents. Without limitation on the foregoing representations and warranties in this Section 5.1(hh):
Food and Drug. Without limitation of Section 4.12, except as set forth on Schedule 4.19, Seller has been, and the Business has been conducted, in compliance in all material respects with the Food, Drug and Cosmetic Act, as amended (the "Act"), and all regulations promulgated thereunder by the United States Food and Drug Administration ("FDA"). Without limitation of the foregoing representation and warranty, Seller further represents and warrants as follows:
Food and Drug. To its Knowledge, the Seller Entity and all of the products and services which it imports, distributes, or provides are, and have at all times been, in compliance with the Food, Drug and Cosmetic Act and all regulations promulgated there under by the United States Food and Drug Administration.
Food and Drug. Set forth on Schedule 6.32 is a correct and complete list of (a) all permits, licenses, and approvals that are required under the laws, rules, and regulations of the United States Food and Drug Administration that are applicable to the Borrowers (the “FDA Laws”) for the operation of the Borrowers’ business (collectively, the “FDA Permits”). Each Borrower has all applicable FDA Permits, all of which (a) are valid and in full force and effect, (b) have not been reversed, stayed, set aside, annulled, or suspended, (c) are not subject to any conditions or requirements that are not generally imposed on the holders thereof, and (d) constitute the only licenses, permits, authorizations, consents, and approvals required from United States Food and Drug Administration (the “FDA”) for the operation of the Borrowers’ business as currently conducted and as contemplated by the Loan Documents. Without limitation on the foregoing representations and warranties in this Section 6.32:
Food and Drug. ADMINISTRATION (FDA). We may disclose to the FDA health information relative to adverse events with respect to food, supplements, product and product defects, or post marketing surveillance information to enable product recalls, repairs, or replacement.
Food and Drug. Except as could not reasonably be expected to result in a Material Adverse Effect, the Borrower and/or its Subsidiaries have all requisite permits, licenses, and approvals that are required under the Laws of the United States Food and Drug Administration (the “FDA”) and under the Laws of the applicable Governmental Authority for each jurisdiction in which the Borrower and its Subsidiaries manufactures, distributes or sells Inventory included in the Borrowing Base (collectively, the “FDA Laws”) for the operation of the business of the Borrower and its Subsidiaries (collectively, the “FDA Permits”) and such FDA Permits (a) are valid and in full force and effect, (b) have not been reversed, stayed, set aside, annulled, or suspended, and are not subject to any investigation by a Governmental Authority to revoke, stay, set aside, annul or suspend any such FDA Permits and (c) are not subject to any conditions or requirements that are not generally imposed on the holders thereof. The Borrower and/or its Subsidiaries are in compliance with all applicable FDA Laws, including, without limitation, those relating to the regulation of medical devices and current good manufacturing practice requirements except as could not reasonably be expected to result in a Material Adverse Effect.
