Food Safety. (a) The Borrower and its Subsidiaries and all products, manufactured, marketed, stored or sold by them, including, without limitation, the pizzas that consumers purchase from the APKs (the “Products”) have complied and are in compliance in all material respects with (1) the applicable provisions of the Federal Food, Drug, and Cosmetic Act and the applicable regulations and requirements adopted by the U.S. Food and Drug Administration (the “FDA”) thereunder, the applicable statutes, regulations and requirements of the U.S. Department of Agriculture (the “USDA”), the applicable statutes enforced by the U.S. Federal Trade Commission (“FTC”), and any applicable law or other comparable requirements established by any state, local or foreign Governmental Authority responsible for regulating food products or the manufacture, production, packaging, labeling, transportation, distribution, sale or marketing thereof (such applicable laws, regulations and other requirements, together with the Federal Food, Drug, and Cosmetic Act, collectively, the “Food Safety Laws”; such Governmental Authorities, together with the FDA, the USDA and the FTC, collectively, the “Food Authorities”) and (2) all terms and conditions imposed in any license or permit granted to the Borrower or any Subsidiary by any Food Authority. (b) All Products are and were to the extent applicable (i) manufactured in all material respects in accordance with good manufacturing practices and sanitation requirements, (ii) if required, manufactured in facilities registered with the FDA or any other applicable Food Authority, (iii) if a food additive, either Generally Recognized As Safe (GRAS) or subject to a valid and approved food additive petition filed with the FDA, and (iv) not adulterated or misbranded within the meaning of the applicable Food Safety Laws. (c) Neither Borrower nor any Subsidiary (i) has, voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, market withdrawal relating to an alleged lack of safety or regulatory compliance of any Product; (ii) has introduced into interstate commerce an adulterated Product under Food Safety Laws; or (iii) as a result of any action taken by a Food Authority or other Governmental Authority, (x) made a change in the labeling of any Product, or (y) terminated or suspended the marketing of any Product. (d) To the knowledge of Borrower, there are no facts or circumstances that would be reasonably likely to cause (A) any Food Authority to require the recall or market withdrawal of any Product, or (B) Borrower or any Subsidiary, as the result of any action of a Food Authority or other Governmental Authority, to make a material change in the labeling of any Product, or to terminate or suspend the marketing of any Product. (e) Without limiting the foregoing, to the Borrower’s knowledge each of the Manufacturers is in compliance with this Section 5.19 to the extent applicable.
Appears in 2 contracts
Samples: Financing Agreement (Basil Street Cafe, Inc.), Financing Agreement (Basil Street Cafe, Inc.)
Food Safety. (a) The Borrower Danube and its Subsidiaries are, and have been since the Reference Date, in material compliance with all productsLaws governing the growing, manufacturedhandling, marketedpurity, stored safety, quality, composition, and labeling of food sold for human or sold by them, including, without limitationanimal consumption that are applicable to the business of Danube and its Subsidiaries (collectively, the pizzas that consumers purchase from “Food Laws”), including with respect to nomenclature and labeling, registration and record keeping in respect of the APKs (Products. To the “Products”) have complied and are in compliance in knowledge of Danube, all material respects Products satisfy Danube’s obligations with (1) the respect to applicable provisions of Food Laws, including the Federal Food, Drug, and Cosmetic Act and implementing regulations including the applicable regulations and requirements adopted by the U.S. Food and Drug Administration (the “FDA”) thereunderSafety Modernization Act, the applicable statutes, regulations and requirements of the U.S. Department of Agriculture (the “USDA”), the applicable statutes enforced by the U.S. Federal Trade Commission (“FTC”)Organic Foods Production Act, and any other applicable law Laws, except, in each case, for any such conflicts, defaults, breaches or other comparable requirements established by violations that would not reasonably be expected to, individually or in the aggregate, be materially adverse to Danube and its Subsidiaries, taken as a whole. As of the date hereof, neither Danube nor any state, local or foreign Governmental Authority responsible for regulating food products or the manufacture, production, packaging, labeling, transportation, distribution, sale or marketing thereof (such applicable laws, regulations and other requirements, together with the Federal Food, Drug, and Cosmetic Act, collectively, the “Food Safety Laws”; such Governmental Authorities, together with the FDA, the USDA and the FTC, collectively, the “Food Authorities”) and (2) all terms and conditions imposed in any license or permit granted to the Borrower or any Subsidiary by any Food Authority.
(b) All Products are and were to the extent applicable of its Subsidiaries has (i) manufactured in all received written notice of any adverse inspection, finding of deficiency or finding of non-compliance, which inspection or finding is material respects in accordance with good manufacturing practices and sanitation requirementsto Danube, (ii) if requiredreceived any written regulatory or warning letter, manufactured in facilities registered with the FDA or any other applicable Food Authority, (iii) if a food additiveto the knowledge of Danube, either Generally Recognized As Safe (GRAS) been the subject of any investigation or subject other compliance or enforcement action, in each case, from or by any Governmental Entity. Danube has in place policies and procedures to a valid and approved food additive petition filed allow for material compliance with the FDA, and (iv) not all Food Laws applicable to Danube. No Product is adulterated or misbranded within the meaning of the applicable Food Safety Laws.
(c) Neither Borrower nor any Subsidiary (i) has, voluntarily except as would not reasonably be expected to, individually or involuntarily initiatedin the aggregate, conducted or issuedbe materially adverse to Danube and its Subsidiaries, or caused to be initiated, conducted or issued, any recall, market withdrawal relating to an alleged lack of safety or regulatory compliance of any Product; (ii) has introduced into interstate commerce an adulterated Product under Food Safety Laws; or (iii) taken as a result of any action taken by a Food Authority or other Governmental Authority, (x) made a change in the labeling of any Product, or (y) terminated or suspended the marketing of any Productwhole.
(d) To the knowledge of Borrower, there are no facts or circumstances that would be reasonably likely to cause (A) any Food Authority to require the recall or market withdrawal of any Product, or (B) Borrower or any Subsidiary, as the result of any action of a Food Authority or other Governmental Authority, to make a material change in the labeling of any Product, or to terminate or suspend the marketing of any Product.
(e) Without limiting the foregoing, to the Borrower’s knowledge each of the Manufacturers is in compliance with this Section 5.19 to the extent applicable.
Appears in 2 contracts
Samples: Business Combination Agreement (Bungeltd), Business Combination Agreement (Bungeltd)