Common use of Food Regulatory Matters Clause in Contracts

Food Regulatory Matters. (a) With respect to all products currently made, sold or marketed, or under development by the Acquired Entities (collectively, the “Products”), the Products have been developed, tested, manufactured, registered, approved, marketed, distributed, labeled, stored or transported, as applicable, in compliance in all material respects with the applicable provisions of the Federal Food, Drug, and Cosmetic Act (the “FDC Act”) and the implementing regulations issued by the U.S. Food and Drug Administration (the “FDA”), and any analogous applicable requirements (collectively, the “Applicable Food Laws”) established by foreign, federal, state or local authorities responsible for regulating any Products and establishments, as well as with all material terms and conditions imposed in any licenses, permits, approvals, clearances, registrations or other authorizations granted to the Acquired Entities by any Governmental Authorities. Neither Seller nor the Acquired Entities have received any written notice or other written communication from any Governmental Authority regarding (i) any actual, alleged, possible or potential violation of, or failure to comply with, any material Applicable Food Laws, or (ii) any actual, alleged, possible or potential obligation on the part of Acquired Entities to undertake, or to bear all or any portion of the cost of, any material remedial action of any nature. There have been no actions pending or, to the knowledge of the Seller, threatened with respect to a material violation by the Acquired Entities of any Applicable Food Laws with regard to the development, testing, manufacture, registration, approval, marketing, distribution, labeling, storage, or transport of any of the Products that reasonably would be expected to result in an administrative, civil, or criminal liability, and, to the knowledge of the Seller, there are no facts or circumstances existing that would reasonably be expected to serve as a basis for such an action. (b) To the knowledge of the Seller, the suppliers that supply goods (including food ingredients or other ingredients) or services in relation to the Products are in compliance in all material respects with the Applicable Food Laws. (c) The Products, and the facilities in which the Products are made, processed, labeled, packaged, handled or stored are not now subject (nor have they been subject during the previous three (3) years) to any adverse inspection, finding, recall, investigation, penalty assessment, audit or other compliance or enforcement action, or, to the knowledge of the Seller, any investigation, by any Governmental Authorities. (d) The Acquired Entities have not been subject to any obligation or requirement arising under any consent decree, consent agreement, inspection report or warning letter issued by or entered into with the FDA, the United States Department of Agriculture (USDA) or the Federal Trade Commission, or any other United States or foreign Governmental Authority with regard to the development, testing, manufacture, registration, approval, marketing, distribution, labeling, storage, or transport of any of the Products. To the knowledge of the Seller, no supplier that supplies goods (including food ingredients or other ingredients) or services in relation to the Products is subject (or has been subject during the previous three (3) years) to any such adverse action with regard to such goods (including food ingredients or other ingredients) or services. (e) To the knowledge of the Seller, the Products: (i) have been, based on current scientific evidence and industry practice, safe for human consumption when used in accordance with the labeling; and (ii) have not been the subject of any notices, decrees, citations, investigations, audits, actions, inquiries or other actions pursuant to The Safe Drinking Water and Toxic Enforcement Act of 1986, as amended, promulgated by the people of the State of California. (f) Claims on the labeling and in the advertising and promotional materials of the Products sold or intended to be sold in the United States are not in violation of Federal Communications Commission (FCC) rules and guidance for environmental claims. (g) The Seller and Acquired Entities have delivered to the Buyer true, correct and complete copies of all Flavor Ingredient Data Sheets for the Products and all documents related to any GRAS “Generally Recognized as Safe” (GRAS) determinations within the meaning of the FDC Act for Products or similar regulations of any foreign country where the Products are manufactured or sold.

Food Regulatory Matters. (a) With respect Except as could not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, Holdings and each of its Subsidiaries is and at all products currently madetimes has been in compliance with all applicable Food Laws, including obtaining, maintaining and complying with all permits, registrations, or licenses required by any Food Laws. (b) Without limiting the generality of the immediately preceding statements, and except as could not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect: (i) neither Holdings nor any of its Subsidiaries has sold or marketed, distributed any products which are or under development by were “adulterated,” “misbranded,” or otherwise violative within the Acquired Entities (collectively, the “Products”), the Products have been developed, tested, manufactured, registered, approved, marketed, distributed, labeled, stored or transported, as applicable, in compliance in all material respects with the applicable provisions meaning of the United States Federal Food, Drug, and Cosmetic Act and/or under any other applicable Food Laws; (the “FDC Act”ii) and the implementing regulations issued by the U.S. Food and Drug Administration (the “FDA”)there have been no recalls, and there are no pending or threatened recalls, of any analogous applicable requirements product manufactured and distributed by Holdings and each of its Subsidiaries; (collectively, iii) all of the “Applicable Food Laws”) established by foreign, federal, state or local authorities responsible for regulating any Products operations of Holdings and establishments, as well as each of its Subsidiaries are and have been in compliance with all material terms and conditions imposed in any licenses, permits, approvals, clearances, registrations or other authorizations granted to the Acquired Entities by any Governmental Authorities. Neither Seller nor the Acquired Entities have received any written notice or other written communication from any Governmental Authority regarding (i) any actual, alleged, possible or potential violation of, or failure to comply with, any material Applicable applicable Food Laws, or (ii) any actualincluding those related to vended water and bottled water quality, alleged, possible or potential obligation on the part of Acquired Entities to undertake, or to bear all or any portion of the cost of, any material remedial action of any nature. There have been no actions pending or, to the knowledge of the Seller, threatened with respect to a material violation by the Acquired Entities of any Applicable Food Laws with regard to the developmentsafety, testing, recordkeeping, manufacture, registration, approval, marketing, distribution, labeling, storage, or transport of transportation, sale, and packaging; (iv) neither Holdings nor any of its Subsidiaries currently and/or at any time has produced any products that contain any ingredients or additives that were not, at the Products that reasonably would be expected to result in an administrativetime of manufacture and sale, civil, or criminal liability, and, to the knowledge of the Seller, there are no facts or circumstances existing that would reasonably be expected to serve as a basis for such an action. (b) To the knowledge of the Seller, the suppliers that supply goods (including food ingredients or additives authorized by the FDA and/or any other ingredients) applicable Governmental Authority as safe for such use, and if not so specifically authorized did not serve to “adulterate” any product of Holdings or services in relation to any of its Subsidiaries within the Products are in compliance in all material respects with the Applicable meaning of applicable Food Laws.; (cv) The Products, and the facilities in which the Products are made, processed, labeled, packaged, handled or stored are not now subject (neither Holdings nor have they any of its Subsidiaries has been subject during the previous three (3) years) to any adverse inspection, findingfinding of deficiency, recallfinding of non-compliance, regulatory or warning letter, investigation, penalty assessment, audit or other compliance or enforcement action, or, from or by the FDA and/or any other Governmental Authority with respect to the knowledge products of the Seller, Holdings or any investigation, by any Governmental Authorities. (d) The Acquired Entities have not been subject to any obligation or requirement arising under any consent decree, consent agreement, inspection report or warning letter issued by or entered into with the FDA, the United States Department of Agriculture (USDA) or the Federal Trade Commissionits Subsidiaries, or any other United States or foreign Governmental Authority with regard to facility used in the development, testing, manufacture, registration, approval, marketing, distribution, labelinghandling, storage, or transport distribution of the products of Holdings or any of its Subsidiaries; (vi) there are no pending or threatened civil, criminal or administrative actions, suits, demands, claims, hearings, investigations, demand letters, proceedings, complaints or requests for information by the Products. To FDA, FTC, and/or any other Governmental Authority related to the knowledge manufacture, distribution, or sale of the Sellerproducts of Holdings or any of its Subsidiaries, and there is no supplier act, omission, event, or circumstance that supplies goods could reasonably be expected to give rise to any such action, suit, demand, claim, hearing, investigation, demand letter, proceeding, complaint or request for information or any such liability; (including food ingredients or vii) Holdings and each of its Subsidiaries has, in a timely manner, filed all reports and notifications with the FDA and/or other ingredients) or services Governmental Authority as required by applicable Food Laws in relation to the Products is subject products and facilities of Holdings and each of its Subsidiaries; (viii) all permits, licenses, facility registrations, product registrations, approvals, and/or authorizations that are necessary to the ongoing conduct of the business that are held in the name of, or used by, or have been issued to Holdings or any of its Subsidiaries are valid and are in full force and effect; (ix) neither Holdings nor any of its Subsidiaries has received notice from the FDA and/or any other Governmental Authority regarding, and there are not any circumstances existing which could be reasonably likely to lead to, any loss of or refusal to renew any permit, registration, or license related to the making or sale of any product of Holdings or any of its Subsidiaries; (x) all labels and labeling for all products manufactured, sold, or distributed by Holdings and each of its Subsidiaries are and at all times have been subject during the previous three correct in all material respects, and comply in all material respects, with all applicable Food Laws; and (3xi) years) to any such adverse action all promotional and advertising materials used or produced by Holdings and each of its Subsidiaries are and at all times have been in compliance with regard to such goods all applicable Food Laws (including food ingredients or those of the FDA, FTC, and/or any other ingredients) or servicesGovernmental Authority). (ec) To the knowledge Holdings and each of the Sellerits Subsidiaries has established compliance programs and procedures reasonably designed to assure compliance, the Products: (i) have beenin all material respects, based on current scientific evidence and industry practice, safe for human consumption when used in accordance with the labeling; and (ii) have not been the subject of any notices, decrees, citations, investigations, audits, actions, inquiries or other actions pursuant to The Safe Drinking Water and Toxic Enforcement Act of 1986, as amended, promulgated by the people of the State of Californiaall applicable Food Laws. (f) Claims on the labeling and in the advertising and promotional materials of the Products sold or intended to be sold in the United States are not in violation of Federal Communications Commission (FCC) rules and guidance for environmental claims. (g) The Seller and Acquired Entities have delivered to the Buyer true, correct and complete copies of all Flavor Ingredient Data Sheets for the Products and all documents related to any GRAS “Generally Recognized as Safe” (GRAS) determinations within the meaning of the FDC Act for Products or similar regulations of any foreign country where the Products are manufactured or sold.

Food Regulatory Matters. (a) With respect Except as could not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, the Borrower and each of its Subsidiaries is and at all products currently madetimes has been in compliance with all applicable Food Laws, including obtaining, maintaining and complying with all permits, registrations, or licenses required by any Food Laws. (b) Without limiting the generality of the immediately preceding statements, and except as could not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect: (i) neither the Borrower nor any of its Subsidiaries has sold or marketed, distributed any products which are or under development by were “adulterated,” “misbranded,” or otherwise violative within the Acquired Entities (collectively, the “Products”), the Products have been developed, tested, manufactured, registered, approved, marketed, distributed, labeled, stored or transported, as applicable, in compliance in all material respects with the applicable provisions meaning of the United States Federal Food, Drug, and Cosmetic Act and/or under any other applicable Food Laws; (the “FDC Act”ii) there have been no recalls, and the implementing regulations issued there are no pending or threatened recalls, of any product manufactured and distributed by the U.S. Food Borrower and Drug Administration each of its Subsidiaries; (iii) all of the “FDA”), operations of the Borrower and any analogous applicable requirements (collectively, the “Applicable Food Laws”) established by foreign, federal, state or local authorities responsible for regulating any Products each of its Subsidiaries are and establishments, as well as have been in compliance with all material terms and conditions imposed in any licenses, permits, approvals, clearances, registrations or other authorizations granted to the Acquired Entities by any Governmental Authorities. Neither Seller nor the Acquired Entities have received any written notice or other written communication from any Governmental Authority regarding (i) any actual, alleged, possible or potential violation of, or failure to comply with, any material Applicable applicable Food Laws, or (ii) any actualincluding those related to vended water and bottled water quality, alleged, possible or potential obligation on the part of Acquired Entities to undertake, or to bear all or any portion of the cost of, any material remedial action of any nature. There have been no actions pending or, to the knowledge of the Seller, threatened with respect to a material violation by the Acquired Entities of any Applicable Food Laws with regard to the developmentsafety, testing, recordkeeping, manufacture, registration, approval, marketing, distribution, labeling, storage, or transport of transportation, sale, and packaging; (iv) neither the Borrower nor any of its Subsidiaries currently and/or at any time has produced any products that contain any ingredients or additives that were not, at the Products that reasonably would be expected to result in an administrativetime of manufacture and sale, civil, or criminal liability, and, to the knowledge of the Seller, there are no facts or circumstances existing that would reasonably be expected to serve as a basis for such an action. (b) To the knowledge of the Seller, the suppliers that supply goods (including food ingredients or additives authorized by the FDA and/or any other ingredients) applicable Governmental Authority as safe for such use, and if not so specifically authorized did not serve to “adulterate” any product of the Borrower or services in relation to any of its Subsidiaries within the Products are in compliance in all material respects with the Applicable meaning of applicable Food Laws.; (cv) The Products, and neither the facilities in which the Products are made, processed, labeled, packaged, handled or stored are not now subject (Borrower nor have they any of its Subsidiaries has been subject during the previous three (3) years) to any adverse inspection, findingfinding of deficiency, recallfinding of non-compliance, regulatory or warning letter, investigation, penalty assessment, audit or other compliance or enforcement action, or, from or by the FDA and/or any other Governmental Authority with respect to the knowledge products of the Seller, Borrower or any investigation, by any Governmental Authorities. (d) The Acquired Entities have not been subject to any obligation or requirement arising under any consent decree, consent agreement, inspection report or warning letter issued by or entered into with the FDA, the United States Department of Agriculture (USDA) or the Federal Trade Commissionits Subsidiaries, or any other United States or foreign Governmental Authority with regard to facility used in the development, testing, manufacture, registration, approval, marketing, distribution, labelinghandling, storage, or transport distribution of the products of the Borrower or any of its Subsidiaries; (vi) there are no pending or threatened civil, criminal or administrative actions, suits, demands, claims, hearings, investigations, demand letters, proceedings, complaints or requests for information by the Products. To FDA, FTC, and/or any other Governmental Authority related to the knowledge manufacture, distribution, or sale of the Sellerproducts of the Borrower or any of its Subsidiaries, and there is no supplier act, omission, event, or circumstance that supplies goods could reasonably be expected to give rise to any such action, suit, demand, claim, hearing, investigation, demand letter, proceeding, complaint or request for information or any such liability; (including food ingredients or vii) the Borrower and each of its Subsidiaries has, in a timely manner, filed all reports and notifications with the FDA and/or other ingredients) or services Governmental Authority as required by applicable Food Laws in relation to the Products is subject products and facilities of the Borrower and each of its Subsidiaries; (viii) all permits, licenses, facility registrations, product registrations, approvals, and/or authorizations that are necessary to the ongoing conduct of the business that are held in the name of, or used by, or have been issued to the Borrower or any of its Subsidiaries are valid and are in full force and effect; (ix) neither the Borrower nor any of its Subsidiaries has received notice from the FDA and/or any other Governmental Authority regarding, and there are not any circumstances existing which could be reasonably likely to lead to, any loss of or refusal to renew any permit, registration, or license related to the making or sale of any product of the Borrower or any of its Subsidiaries; (x) all labels and labeling for all products manufactured, sold, or distributed by the Borrower and each of its Subsidiaries are and at all times have been subject during correct in all material respects, and comply in all material respects, with all applicable Food Laws; and (xi) all promotional and advertising materials used or produced by the previous three (3) years) to any such adverse action Borrower and each of its Subsidiaries are and at all times have been in compliance with regard to such goods all applicable Food Laws (including food ingredients or those of the FDA, FTC, and/or any other ingredients) or servicesGovernmental Authority). (e) To the knowledge of the Seller, the Products: (i) have been, based on current scientific evidence and industry practice, safe for human consumption when used in accordance with the labeling; and (ii) have not been the subject of any notices, decrees, citations, investigations, audits, actions, inquiries or other actions pursuant to The Safe Drinking Water and Toxic Enforcement Act of 1986, as amended, promulgated by the people of the State of California. (f) Claims on the labeling and in the advertising and promotional materials of the Products sold or intended to be sold in the United States are not in violation of Federal Communications Commission (FCC) rules and guidance for environmental claims. (gc) The Seller Borrower and Acquired Entities each of its Subsidiaries have delivered established compliance programs and procedures reasonably designed to the Buyer trueassure compliance, correct and complete copies of in all Flavor Ingredient Data Sheets for the Products and material respects, with all documents related to any GRAS “Generally Recognized as Safe” (GRAS) determinations within the meaning of the FDC Act for Products or similar regulations of any foreign country where the Products are manufactured or soldapplicable Food Laws.