Food Safety Matters. (a) To the Company’s knowledge, since the Reference Date, except as would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect, all products manufactured, marketed, sold or distributed by or on behalf of the Company or its Subsidiaries (“Company Products”) have complied and are in compliance in all material respects with all applicable Food Laws. (b) All Company Products manufactured or processed by or for the Company or any of its Subsidiaries for introduction into United States commerce consist only of FDA- approved food and color additives, prior sanctioned substances and “generally recognized as safe” ingredients. (c) Neither the Company, any Subsidiary nor any Company Product has been the subject of any adverse notification from any Governmental Authority (including any inspection reports on Form 483, FDA Notice of Intended Enforcement, Notice of Suspension by the USDA or enforcement action, warning letter, untitled letter, seizure, injunction, fine or sanction, civil or criminal action issued, initiated, or threatened in writing by the FDA, USDA, FTC, any comparable (d) Since the Reference Date, except as would not reasonably be expected to be have, individually or in the aggregate, a Material Adverse Effect, all material registrations, reports, documents, Permits or notices required to be filed, maintained or furnished to any Governmental Authority (collectively, “Food Regulatory Filings”) have been so filed, maintained or furnished in a timely manner, and all such Food Regulatory Filings were complete and accurate in all material respects on the date filed (or were corrected in, or supplemented by, a subsequent filing). (e) Neither the Company nor any of its Subsidiaries or, to the Company’s knowledge, any officer, employee, agent or distributor has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Governmental Authority or failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Authority on behalf of the Company or any of its Subsidiaries. (f) Since the Reference Date, (i) no Company Product has been the subject of any voluntary withdrawal or any mandatory or voluntary recall, market withdrawal, public notification, or notification to any Governmental Authority, or any similar action; and (ii) to the Company’s knowledge, there is no reason to believe that a basis for a recall or withdrawal of any of such Company Products exists under applicable Laws, Food Laws or any policy applicable to the Company, or that a recall of any of such Company Products has been threatened by any Governmental Authority or is being considered by the Company. (g) Since the Reference Date, no customer or subsequent purchaser of any Company Product has asserted a claim with respect to Company’s facilities, operations, or any nonconformity of any Company Product with applicable specifications, warranties or regulatory requirements. (h) All promotional and advertising materials used or produced by the Company, as well as all marketing activities, currently and since the Reference Date comply in all material respects with all applicable Laws (including applicable Food Laws). (i) The representations and warranties set forth in this Section 2.19 are the sole and exclusive representations and warranties of the Company and its Subsidiaries with respect to food safety matters.
Appears in 1 contract
Food Safety Matters. (a) To Except as otherwise set forth on Disclosure Schedule 5.10, the Company’s knowledgeBusiness is, and has been since January 1, 2016, conducted in compliance with all Applicable Laws related to the Reference Datedevelopment, cultivation, manufacture, production, import, export, packaging, packing, labeling, handling, storage, transportation, distribution, purchase, sale, advertising or marketing of food and related products (collectively, “Applicable Food Safety Laws”), except as would not reasonably be expected material to havethe Acquired Business. Without limiting the generality of the immediately preceding statement, individually except as otherwise set forth on Disclosure Schedule 5.10 and except as would not be material to the Acquired Business:
(b) no Selling Entity has sold or in the aggregatedistributed any Food and Beverage Products, a Material Adverse Effect, all products and there are not any Food and Beverage Products manufactured, marketed, sold or distributed by or on behalf of the Company Business currently in inventory, which are or its Subsidiaries (were “Company Products”) have complied and are adulterated,” “misbranded,” or otherwise violative in compliance in all any material respects with all applicable Food Laws.
(b) All Company Products manufactured or processed by or for respect within the Company or meaning of the FDC Act, and/or under any of its Subsidiaries for introduction into United States commerce consist only of FDA- approved food and color additives, prior sanctioned substances and “generally recognized as safe” ingredients.other Applicable Law;
(c) Neither all of the Companyoperations of the Business are and have been in material compliance with all Applicable Laws issued or implemented by the FDA, USDA, FTC and/or any Subsidiary nor any Company Product other comparable Governmental Authority, including those related to recordkeeping, prior notice of imported food, food safety, hazard analysis and preventive controls, sanitary transportation, food additives, food contact substances, supplier verification, food facility registration, current good manufacturing practices, allergen control, and food labeling and advertising;
(d) no Selling Entity has been the subject of any adverse notification from any Governmental Authority (including to any inspection reports on identifying material violations of Applicable Law, FDA Form 483, FDA Notice of Intended Enforcement, Notice of Suspension by the USDA or enforcement action, warning letter, untitled letter, seizurefinding of deficiency, injunctioninvestigation, fine or sanctionany other compliance or enforcement Proceeding, civil or criminal action issuedother correspondence or notice alleging or asserting material noncompliance with any Applicable Law or Permit, initiatedfrom or by any Governmental Authority with respect to the Business, nor are there any such Proceedings pending or threatened in writing by writing;
(e) since January 1, 2016, no Selling Entity has received any material written, oral or other notice from the FDA, USDA, FTCFTC or any other comparable Governmental Authority in connection with any Food and Beverage Product manufactured, any comparablesold or distributed by or on behalf of the Business;
(df) Since since January 1, 2016, no Selling Entity has been excluded, suspended or debarred from participation under any government program with respect to the Reference Date, except as would not reasonably be expected to be have, individually or in the aggregate, a Material Adverse Effect, all material registrations, reports, documents, Permits or notices required to be filed, maintained or furnished Business pursuant to any Applicable Food Safety Law;
(g) since January 1, 2016, there have been no recalls, withdrawals, field notifications or other notices of action relating to any lack of safety or regulatory compliance of or regarding any Food and Beverage Product cultivated, manufactured, produced, packaged, labeled, distributed or sold by or on behalf of the Business, whether ordered by a Governmental Authority (collectivelyor undertaken voluntarily by any Selling Entity, “Food Regulatory Filings”) and there have been so filedno claims or other instances of the presence of or exposure to any food contaminants or adulterants, maintained food borne pathogens, food poisoning, pests, or furnished other Hazardous Substance in a timely manneror related to any such products, nor any other food-related conditions with respect to the Business;
(h) each Food and all such Food Regulatory Filings were complete and accurate Beverage Product cultivated, manufactured, produced, packaged, labeled, distributed or sold by or on behalf of the Business conforms in all material respects to any promises, claims or affirmations of fact made on the date filed container or label for such product or in connection with its distribution or sale (or were corrected inincluding, without limitation, all nutrition facts, ingredient statements, nutrient content claims, structure/function claims, health claims and to the extent that such products are being marketed as such, “non-GMO,” “fresh,” “organic,” “all natural,” “sustainable,” “U.S. grown,” “made with natural ingredients,” “gluten free,” “made with rBST- free milk,” “kosher,” “all natural,” “no corn syrup,” “no artificial colors, flavors, or supplemented bysweeteners,” “nutritious” or with similar claims) and the Selling Entities possess appropriate certifications or scientifically reliable materials to substantiate all such promises, a subsequent filing).claims and affirmations of fact; and
(ei) Neither the Company nor any of its Subsidiaries oreach Food and Beverage Product cultivated, to the Company’s knowledgemanufactured, any officerproduced, employeepackaged, agent labeled, distributed or distributor has made an untrue statement of a material fact sold by or a fraudulent statement to the FDA or any other Governmental Authority or failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Authority on behalf of the Company or any of its Subsidiaries.
(f) Since the Reference Date, (i) no Company Product has been the subject of any voluntary withdrawal or any mandatory or voluntary recall, market withdrawal, public notification, or notification to any Governmental Authority, or any similar action; and (ii) to the Company’s knowledge, there is no reason to believe that a basis for a recall or withdrawal of any of such Company Products exists under applicable Laws, Food Laws or any policy applicable to the Company, or that a recall of any of such Company Products has been threatened by any Governmental Authority or is being considered by the Company.
(g) Since the Reference Date, no customer or subsequent purchaser of any Company Product has asserted a claim with respect to Company’s facilities, operations, or any nonconformity of any Company Product with applicable specifications, warranties or regulatory requirements.
(h) All promotional and advertising materials used or produced by the Company, as well as all marketing activities, currently and since the Reference Date comply Business complies in all material respects with all applicable Laws (including applicable Food Laws).
(i) The representations and warranties set forth FDA’s requirements in this Section 2.19 are the sole and exclusive representations and warranties Title 21 of the Company Code of Federal Regulations section 100.100 for nonfunctional slack fill and its Subsidiaries with respect to food safety mattersany other similar state or local requirements, and no Selling Entity has received any correspondence from any Governmental Authority alleging that any Food and Beverage Product’s container and/or packaging is deceptive because of nonfunctional slack fill.
Appears in 1 contract
Samples: Asset Purchase Agreement
Food Safety Matters. (a) To Except as otherwise set forth on Disclosure Schedule 5.10, the Company’s knowledgeBusiness is, and has been since January 1, 2016, conducted in compliance with all Applicable Laws related to the Reference Datedevelopment, cultivation, manufacture, production, import, export, packaging, packing, labeling, handling, storage, transportation, distribution, purchase, sale, advertising or marketing of food and related products (collectively, “Applicable Food Safety Laws”), except as would not reasonably be expected material to havethe Acquired Business. Without limiting the generality of the immediately preceding statement, individually except as otherwise set forth on Disclosure Schedule 5.10 and except as would not be material to the Acquired Business:
(b) no Selling Entity has sold or in the aggregatedistributed any Food and Beverage Products, a Material Adverse Effect, all products and there are not any Food and Beverage Products manufactured, marketed, sold or distributed by or on behalf of the Company Business currently in inventory, which are or its Subsidiaries (were “Company Products”) have complied and are adulterated,” “misbranded,” or otherwise violative in compliance in all any material respects with all applicable Food Laws.
(b) All Company Products manufactured or processed by or for respect within the Company or meaning of the FDC Act, and/or under any of its Subsidiaries for introduction into United States commerce consist only of FDA- approved food and color additives, prior sanctioned substances and “generally recognized as safe” ingredients.other Applicable Law;
(c) Neither all of the Companyoperations of the Business are and have been in material compliance with all Applicable Laws issued or implemented by the FDA, USDA, FTC and/or any Subsidiary nor any Company Product other comparable Governmental Authority, including those related to recordkeeping, prior notice of imported food, food safety, hazard analysis and preventive controls, sanitary transportation, food additives, food contact substances, supplier verification, food facility registration, current good manufacturing practices, allergen control, and food labeling and advertising;
(d) no Selling Entity has been the subject of any adverse notification from any Governmental Authority (including to any inspection reports on identifying material violations of Applicable Law, FDA Form 483, FDA Notice of Intended Enforcement, Notice of Suspension by the USDA or enforcement action, warning letter, untitled letter, seizurefinding of deficiency, injunctioninvestigation, fine or sanctionany other compliance or enforcement Proceeding, civil or criminal action issuedother correspondence or notice alleging or asserting material noncompliance with any Applicable Law or Permit, initiatedfrom or by any Governmental Authority with respect to the Business, nor are there any such Proceedings pending or threatened in writing by writing;
(e) since January 1, 2016, no Selling Entity has received any material written, oral or other notice from the FDA, USDA, FTCFTC or any other comparable Governmental Authority in connection with any Food and Beverage Product manufactured, any comparablesold or distributed by or on behalf of the Business;
(df) Since since January 1, 2016, no Selling Entity has been excluded, suspended or debarred from participation under any government program with respect to the Reference Date, except as would not reasonably be expected to be have, individually or in the aggregate, a Material Adverse Effect, all material registrations, reports, documents, Permits or notices required to be filed, maintained or furnished Business pursuant to any Applicable Food Safety Law;
(g) since January 1, 2016, there have been no recalls, withdrawals, field notifications or other notices of action relating to any lack of safety or regulatory compliance of or regarding any Food and Beverage Product cultivated, manufactured, produced, packaged, labeled, distributed or sold by or on behalf of the Business, whether ordered by a Governmental Authority (collectivelyor undertaken voluntarily by any Selling Entity, “Food Regulatory Filings”) and there have been so filedno claims or other instances of the presence of or exposure to any food contaminants or adulterants, maintained food borne pathogens, food poisoning, pests, or furnished other Hazardous Substance in a timely manneror related to any such products, nor any other food-related conditions with respect to the Business;
(h) each Food and all such Food Regulatory Filings were complete and accurate Beverage Product cultivated, manufactured, produced, packaged, labeled, distributed or sold by or on behalf of the Business conforms in all material respects to any promises, claims or affirmations of fact made on the date filed container or label for such product or in connection with its distribution or sale (or were corrected inincluding, without limitation, all nutrition facts, ingredient statements, nutrient content claims, structure/function claims, health claims and to the extent that such products are being marketed as such, “non-GMO,” “fresh,” “organic,” “all natural,” “sustainable,” “U.S. grown,” “made with natural ingredients,” “gluten free,” “made with rBST-free milk,” “kosher,” “all natural,” “no corn syrup,” “no artificial colors, flavors, or supplemented bysweeteners,” “nutritious” or with similar claims) and the Selling Entities possess appropriate certifications or scientifically reliable materials to substantiate all such promises, a subsequent filing).claims and affirmations of fact; and
(ei) Neither the Company nor any of its Subsidiaries oreach Food and Beverage Product cultivated, to the Company’s knowledgemanufactured, any officerproduced, employeepackaged, agent labeled, distributed or distributor has made an untrue statement of a material fact sold by or a fraudulent statement to the FDA or any other Governmental Authority or failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Authority on behalf of the Company or any of its Subsidiaries.
(f) Since the Reference Date, (i) no Company Product has been the subject of any voluntary withdrawal or any mandatory or voluntary recall, market withdrawal, public notification, or notification to any Governmental Authority, or any similar action; and (ii) to the Company’s knowledge, there is no reason to believe that a basis for a recall or withdrawal of any of such Company Products exists under applicable Laws, Food Laws or any policy applicable to the Company, or that a recall of any of such Company Products has been threatened by any Governmental Authority or is being considered by the Company.
(g) Since the Reference Date, no customer or subsequent purchaser of any Company Product has asserted a claim with respect to Company’s facilities, operations, or any nonconformity of any Company Product with applicable specifications, warranties or regulatory requirements.
(h) All promotional and advertising materials used or produced by the Company, as well as all marketing activities, currently and since the Reference Date comply Business complies in all material respects with all applicable Laws (including applicable Food Laws).
(i) The representations and warranties set forth FDA’s requirements in this Section 2.19 are the sole and exclusive representations and warranties Title 21 of the Company Code of Federal Regulations section 100.100 for nonfunctional slack fill and its Subsidiaries with respect to food safety mattersany other similar state or local requirements, and no Selling Entity has received any correspondence from any Governmental Authority alleging that any Food and Beverage Product’s container and/or packaging is deceptive because of nonfunctional slack fill.
Appears in 1 contract
Food Safety Matters. Except as otherwise set forth on Disclosure Schedule 5.09, the Business is, and has been since January 1, 2017, conducted in material compliance with all Applicable Laws related to the development, cultivation, manufacture, production, import, export, packaging, packing, labeling, handling, storage, transportation, distribution, purchase, sale, advertising or marketing of food and related products (a) To the Company’s knowledgecollectively, since the Reference Date“Applicable Food Safety Laws”), except as would not reasonably be expected to have, material individually or in the aggregateaggregate to the Business. Without limiting the generality of the immediately preceding statement, a Material Adverse Effectsince January 1, all products manufactured2017, marketedand except as otherwise set forth on Disclosure Schedule 5.09, and except as would not be material individually or in the aggregate to the Business:
(a) neither Seller nor any of its Subsidiaries has sold or distributed by any Food and Beverage Products, and there are not any Food and Beverage Products currently in inventory, which, in any material respect, are or on behalf were “adulterated,” “misbranded,” not permitted to be introduced into interstate commerce or otherwise violative within the meaning of the Company or its Subsidiaries FDC Act, and/or under any other Applicable Food Safety Law;
(“Company Products”b) all of the operations of the Business are and have complied and are been in compliance in all material respects with all applicable Food Laws.
(b) All Company Products manufactured Applicable Laws issued or processed by or for the Company or any of its Subsidiaries for introduction into United States commerce consist only of FDA- approved food and color additives, prior sanctioned substances and “generally recognized as safe” ingredients.
(c) Neither the Company, any Subsidiary nor any Company Product has been the subject of any adverse notification from any Governmental Authority (including any inspection reports on Form 483, FDA Notice of Intended Enforcement, Notice of Suspension by the USDA or enforcement action, warning letter, untitled letter, seizure, injunction, fine or sanction, civil or criminal action issued, initiated, or threatened in writing implemented by the FDA, USDA, FTC, state departments of health, state departments of agriculture, and any comparableother comparable Governmental Authority, including those related to recordkeeping, prior notice of imported food, food safety, hazard analysis and preventive controls, sanitary transportation, food additives, food contact substances, supplier verification, food facility registration, current good manufacturing practices, allergen control, juice processing, food labeling and advertising, and the production, processing, and packaging of Grade A milk and milk products;
(c) all of the operations of the Business are and have been in compliance with all Permits and Certifications that are currently held by Seller or any of its Subsidiaries or which are otherwise necessary for the operation of the Business or required pursuant to any Applicable Laws or which are necessary due to the packaging or labeling of any products;
(d) Since the Reference Date, except as would not reasonably be expected to be have, individually or in the aggregate, a Material Adverse Effect, all material registrations, reports, documents, Permits or notices required to be filed, maintained or furnished to any Governmental Authority (collectively, “Food Regulatory Filings”) have been so filed, maintained or furnished in a timely manner, and all such Food Regulatory Filings were complete and accurate in all material respects on the date filed (or were corrected in, or supplemented by, a subsequent filing).
(e) Neither the Company neither Seller nor any of its Subsidiaries has been subject to any inspection identifying material violations of Applicable Food Safety Laws, FDA Form 483, warning letter, untitled letter, investigation, facility suspension, import refusal, or any other compliance or enforcement Proceeding, or other correspondence or notice alleging or asserting material noncompliance with any Applicable Food Safety Law, Permit or Certification, from or by any Governmental Authority (including the FDA, USDA, FTC, state departments of health, and state departments of agriculture) with respect to the Business or any Food and Beverage Product, nor are there any such Proceedings pending or threatened in writing or, to the Company’s knowledgeKnowledge of the Selling Entities, facts or circumstances in existence that would reasonably be expected to result in any officersuch notice or any such violation or liability;
(e) since January 1, employee2017, agent neither Seller nor any of its Subsidiaries has been excluded, suspended or distributor has made an untrue statement of a material fact or a fraudulent statement debarred from participation under any government program with respect to the FDA Business pursuant to any Applicable Food Safety Law;
(f) since January 1, 2017, there have been no mandatory or voluntary product recalls, product withdrawals, field notifications or other notices of action relating to any other Governmental Authority lack of safety or failed to disclose a material fact required to be disclosed to the FDA regulatory compliance of or regarding any other Governmental Authority Food and Beverage Product cultivated, manufactured, produced, packaged, labeled, distributed or sold by or on behalf of the Company or any of its Subsidiaries.
(f) Since the Reference DateBusiness, (i) no Company Product has been the subject of any voluntary withdrawal or any mandatory or voluntary recall, market withdrawal, public notification, or notification to any Governmental Authority, or any similar action; and (ii) to the Company’s knowledge, there is no reason to believe that whether ordered by a basis for a recall or withdrawal of any of such Company Products exists under applicable Laws, Food Laws or any policy applicable to the Company, or that a recall of any of such Company Products has been threatened by any Governmental Authority or is being considered undertaken voluntarily by any Selling Entity, and there have been no claims or other instances of the Company.material presence of or exposure to any food contaminants or adulterants, food borne pathogens, food poisoning, pests, or other Hazardous Substance in or related to any such products, nor any other food-related conditions with respect to the Business;
(g) Since since January 1, 2017, each Food and Beverage Product cultivated, manufactured, produced, packaged, labeled, marketed, distributed or sold by or on behalf of the Reference DateBusiness conforms in all material respects to any promises, no customer claims or subsequent purchaser affirmations of fact made on the container or label for such product, in any Company Product has asserted a claim with respect to Company’s facilitiesadvertising, operationsmarketing, or any nonconformity other related materials, or otherwise in connection with its distribution or sale (including, without limitation, all nutrition facts, ingredient statements, nutrient content claims, structure/function claims, health claims and to the extent that such products are being marketed as such, “non-GMO,” “fresh,” “organic,” “all natural” or “natural,” “sustainable,” “U.S. grown,” ”Made in USA,” “made with natural ingredients,” “gluten free,” “made with rBST-free milk,” “kosher,” “no corn syrup,” “no artificial colors, flavors, or sweeteners,” “nutritious” or with similar claims) and the Selling Entities possess appropriate certifications or scientifically reliable materials to substantiate all such promises, claims and affirmations of any Company Product with applicable specifications, warranties or regulatory requirements.fact; and
(h) All promotional each Food and advertising materials used Beverage Product cultivated, manufactured, produced, packaged, labeled, marketed distributed or produced sold by or on behalf of the Company, as well as all marketing activities, currently and since the Reference Date comply Business complies in all material respects with all applicable Laws (including applicable Food Laws).
(i) The representations and warranties set forth FDA’s requirements in this Section 2.19 are the sole and exclusive representations and warranties Title 21 of the Company Code of Federal Regulations section 100.100 for nonfunctional slack fill and its Subsidiaries with respect any other similar state or local requirements, and, to food safety mattersthe Knowledge of the Selling Entities, no Selling Entity has received any written correspondence from any Person or Governmental Authority alleging that any Food and Beverage Product’s container and/or packaging is deceptive because of nonfunctional slack fill.
Appears in 1 contract
Samples: Asset Purchase Agreement