Common use of Product Recalls Clause in Contracts

Product Recalls. (a) During the past three (3) years, there has not been, nor is there currently ongoing by any Seller or any Affiliate of a Seller, or to the Knowledge of the Sellers, any Governmental Authority, any recall or post-sale warning in respect of any product of the Business in the Territory, except for recalls that have been reported to the U.S. Food and Drug Administration (the “US FDA”) and have been completed in accordance with the US FDA’s requirements. During the past three (3) years, none of the Sellers or their Affiliates has received written notice of any material Action involving any product designed, manufactured, distributed or sold by or on behalf of the Business in the Territory resulting from an alleged defect in design or manufacture, any alleged hazard or impurity, or any alleged failure to warn, or from any alleged breach of implied warranties or representations, or any alleged noncompliance with any Laws, other than immaterial notices or claims that have been settled or resolved by the Sellers prior to the date of this Agreement. (b) None of the products designed, manufactured, distributed or sold by or on behalf of the Business have been adulterated or misbranded by the Sellers or their Affiliates within the meaning of the Federal Food, Drug and Cosmetic Act, as amended (the “FDC Act”), or the rules or regulations issued thereunder or any comparable state law, rule or regulation in a manner that had a Material Adverse Effect or are articles that may not be introduced into interstate commerce under the provisions of Sections 404 or 505 of the FDC Act. No Seller or Affiliate of any Seller has, at any time during the past three (3) years, (i) received any written notice from the US FDA or from comparable state governmental or regulatory body of any material violation of the FDC Act or of comparable state laws, rules or regulations regarding any products sold by the Business within the Territory, (ii) been the subject of any governmental or regulatory enforcement action or, to the Knowledge of the Sellers, investigation action under the FDC Act, the rules and regulations thereunder or comparable state laws, rules or regulations with respect to any products sold within the Territory or (iii) undertaken any recall of products of the Business within the Territory that may have been adulterated, misbranded or otherwise made in violation of the FDC Act or the rules and regulations thereunder or comparable state laws, rules or regulations, except for recalls that have been reported to the US FDA and have been completed in accordance with US FDA’s requirements.

Product Recalls. (a) During the past three (3) years, there has not been, nor is there currently ongoing by any Seller or any Affiliate of a Seller, or to the Knowledge of the Sellers, any Governmental Authority, any recall or post-sale warning in respect of any product of the Business in the TerritoryBusiness, except for recalls that have been reported to the U.S. Food and Drug Administration (the “US FDA”) and have been completed in accordance with the US FDA’s requirements. During the past three (3) years, none of the Sellers or their Affiliates has received written notice of any material Action involving any product designed, manufactured, distributed or sold by or on behalf of the Business in the Territory resulting from an alleged defect in design or manufacture, any alleged hazard or impurity, or any alleged failure to warn, or from any alleged breach of implied warranties or representations, or any alleged noncompliance with any Laws, other than immaterial notices or claims that have been settled or resolved by the Sellers prior to the date of this Agreement. (b) None of the products designed, manufactured, distributed or sold by or on behalf of the Business have been adulterated or misbranded by the Sellers or their Affiliates within the meaning of the Federal Food, Drug and Cosmetic Act, as amended (the “FDC Act”), or the rules or regulations issued thereunder or any comparable state law, rule or regulation in a manner that had a Material Adverse Effect or are articles that may not be introduced into interstate commerce under the provisions of Sections 404 or 505 of the FDC Act. No Seller or Affiliate of any Seller has, at any time during the past three (3) years, (i) received any written notice from the US FDA or from comparable state governmental or regulatory body of any material violation of the FDC Act or of comparable state laws, rules or regulations regarding any products sold by the Business within the TerritoryBusiness, (ii) been the subject of any governmental or regulatory enforcement action or, to the Knowledge of the Sellers, investigation action under the FDC Act, the rules and regulations thereunder or comparable state laws, rules or regulations with respect to any products sold within by the Territory Business or (iii) undertaken any recall of products of the Business within the Territory that may have been adulterated, misbranded or otherwise made in violation of the FDC Act or the rules and regulations thereunder or comparable state laws, rules or regulations, except for recalls that have been reported to the US FDA and have been completed in accordance with US FDA’s requirements.

Product Recalls. (a) During the past three (3) years, there has not been, nor is there currently ongoing by any Seller CCBCC Party or any Affiliate of a SellerCCBCC Party, or to the Knowledge of the SellersCCBCC Parties, any Governmental Authority, any recall or post-sale warning in respect of any product of the Business in the TerritoryCCBCC Business, except for recalls that have been reported to the U.S. Food and Drug Administration (the “US FDA”) FDA and have been completed in accordance with the US FDA’s requirements. During the past three (3) years, none of the Sellers CCBCC Parties or their Affiliates has received written notice of any material Action involving any product designed, manufactured, distributed or sold by or on behalf of the CCBCC Business in the Territory resulting from an alleged defect in design or manufacture, any alleged hazard or impurity, or any alleged failure to warn, or from any alleged breach of implied warranties or representations, or any alleged noncompliance with any Laws, other than immaterial notices or claims that have been settled or resolved by the Sellers CCBCC Parties prior to the date of this Agreement. (b) None of the products designed, manufactured, distributed or sold by or on behalf of the CCBCC Business have been adulterated or misbranded by the Sellers CCBCC Parties or their Affiliates within the meaning of the Federal Food, Drug and Cosmetic Act, as amended (the “FDC Act”), or the rules or regulations issued thereunder or any comparable state law, rule or regulation in a manner that had a CCBCC Material Adverse Effect or are articles that may not be introduced into interstate commerce under the provisions of Sections 404 or 505 of the FDC Act. No Seller CCBCC Party or any Affiliate of any Seller a CCBCC Party has, at any time during the past three (3) years, (i) received any written notice from the US FDA or from comparable state governmental or regulatory body of any material violation of the FDC Act or of comparable state laws, rules or regulations regarding any products sold by the Business within the TerritoryCCBCC Business, (ii) been the subject of any governmental or regulatory enforcement action or, to the Knowledge of the SellersCCBCC Parties, investigation action under the FDC Act, the rules and regulations thereunder or comparable state laws, rules or regulations with respect to any products sold within by the Territory CCBCC Business or (iii) undertaken any recall of products of the CCBCC Business within the Territory that may have been adulterated, misbranded or otherwise made in violation of the FDC Act or the rules and regulations thereunder or comparable state laws, rules or regulations, except for recalls that have been reported to the US FDA and have been completed in accordance with US FDA’s requirements.

Product Recalls. (a) During the past three (3) years, there has not been, nor is there currently ongoing by any Seller CCBU Party or any Affiliate of a SellerCCBU Party, or to the Knowledge of the SellersCCBU Parties, any Governmental Authority, any recall or post-sale warning in respect of any product of the CCBU Business in the CCBU Territory, except for recalls that have been reported to the U.S. Food and Drug Administration (the “US FDA”) and have been completed in accordance with the US FDA’s requirements. During the past three (3) years, none of the Sellers CCBU Parties or their Affiliates has received written notice of any material Action involving any product designed, manufactured, distributed or sold by or on behalf of the CCBU Business in the CCBU Territory resulting from an alleged defect in design or manufacture, any alleged hazard or impurity, or any alleged failure to warn, or from any alleged breach of implied warranties or representations, or any alleged noncompliance with any Laws, other than immaterial notices or claims that have been settled or resolved by the Sellers CCBU Parties prior to the date of this Agreement. (ba) None of the products designed, manufactured, distributed or sold by or on behalf of the CCBU Business have been adulterated or misbranded by the Sellers CCBU Parties or their Affiliates within the meaning of the Federal Food, Drug and Cosmetic Act, as amended (the “FDC Act”), or the rules or regulations issued thereunder or any comparable state law, rule or regulation in a manner that had a CCBU Material Adverse Effect or are articles that may not be introduced into interstate commerce under the provisions of Sections 404 or 505 of the FDC Act. No Seller CCBU Party or Affiliate of any Seller CCBU Party has, at any time during the past three (3) years, (i) received any written notice from the US FDA or from comparable state governmental or regulatory body of any material violation of the FDC Act or of comparable state laws, rules or regulations regarding any products sold by the CCBU Business within the CCBU Territory, (ii) been the subject of any governmental or regulatory enforcement action or, to the Knowledge of the SellersCCBU Parties, investigation action under the FDC Act, the rules and regulations thereunder or comparable state laws, rules or regulations with respect to any products sold within the CCBU Territory or (iii) undertaken any recall of products of the CCBU Business within the CCBU Territory that may have been adulterated, misbranded or otherwise made in violation of the FDC Act or the rules and regulations thereunder or comparable state laws, rules or regulations, except for recalls that have been reported to the US FDA and have been completed in accordance with US FDA’s requirements.

Product Recalls. (a) During the past three (3) years, there has not been, nor is there currently ongoing by any Seller CCR Party or any Affiliate of a SellerCCR Party, or to the Knowledge of the SellersCCR Parties, any Governmental Authority, any recall or post-sale warning in respect of any product of the CCR Business in the CCR Territory, except for recalls that have been reported to the U.S. Food and Drug Administration (the “US FDA”) and have been completed in accordance with the US FDA’s requirements. During the past three (3) years, none of the Sellers CCR Parties or their Affiliates has received written notice of any material Action involving any product designed, manufactured, distributed or sold by or on behalf of the CCR Business in the CCR Territory resulting from an alleged defect in design or manufacture, any alleged hazard or impurity, or any alleged failure to warn, or from any alleged breach of implied warranties or representations, or any alleged noncompliance with any Laws, other than immaterial notices or claims that have been settled or resolved by the Sellers CCR Parties prior to the date of this Agreement. (b) None of the products designed, manufactured, distributed or sold by or on behalf of the CCR Business have been adulterated or misbranded by the Sellers CCR Parties or their Affiliates within the meaning of the Federal Food, Drug and Cosmetic Act, as amended (the “FDC Act”), or the rules or regulations issued thereunder or any comparable state law, rule or regulation in a manner that had a CCR Material Adverse Effect or are articles that may not be introduced into interstate commerce under the provisions of Sections 404 or 505 of the FDC Act. No Seller CCR Party or Affiliate of any Seller CCR Party has, at any time during the past three (3) years, (i) received any written notice from the US FDA or from comparable state governmental or regulatory body of any material violation of the FDC Act or of comparable state laws, rules or regulations regarding any products sold by the CCR Business within the CCR Territory, (ii) been the subject of any governmental or regulatory enforcement action or, to the Knowledge of the SellersCCR Parties, investigation action under the FDC Act, the rules and regulations thereunder or comparable state laws, rules or regulations with respect to any products sold within the CCR Territory or (iii) undertaken any recall of products of the CCR Business within the CCR Territory that may have been adulterated, misbranded or otherwise made in violation of the FDC Act or the rules and regulations thereunder or comparable state laws, rules or regulations, except for recalls that have been reported to the US FDA and have been completed in accordance with US FDA’s requirements.

Product Recalls. (a) During the past three (3) years, there has not been, nor is there currently ongoing by any Seller CCBCC Party or any Affiliate of a SellerCCBCC Party, or to the Knowledge of the SellersCCBCC Parties, any Governmental Authority, any recall or post-sale warning in respect of any product of the CCBCC Business in the CCBCC Territory, except for recalls that have been reported to the U.S. Food and Drug Administration (the “US FDA”) FDA and have been completed in accordance with the US FDA’s requirements. During the past three (3) years, none of the Sellers CCBCC Parties or their Affiliates has received written notice of any material Action involving any product designed, manufactured, distributed or sold by or on behalf of the CCBCC Business in the CCBCC Territory resulting from an alleged defect in design or manufacture, any alleged hazard or impurity, or any alleged failure to warn, or from any alleged breach of implied warranties or representations, or any alleged noncompliance with any Laws, other than immaterial notices or claims that have been settled or resolved by the Sellers CCBCC Parties prior to the date of this Agreement. (b) None of the products designed, manufactured, distributed or sold by or on behalf of the CCBCC Business have been adulterated or misbranded by the Sellers CCBCC Parties or their Affiliates within the meaning of the Federal Food, Drug and Cosmetic Act, as amended (the “FDC Act”), or the rules or regulations issued thereunder or any comparable state law, rule or regulation in a manner that had a CCBCC Material Adverse Effect or are articles that may not be introduced into interstate commerce under the provisions of Sections 404 or 505 of the FDC Act. No Seller CCBCC Party or any Affiliate of any Seller a CCBCC Party has, at any time during the past three (3) years, (i) received any written notice from the US FDA or from comparable state governmental or regulatory body of any material violation of the FDC Act or of comparable state laws, rules or regulations regarding any products sold by the CCBCC Business within the CCBCC Territory, (ii) been the subject of any governmental or regulatory enforcement action or, to the Knowledge of the SellersCCBCC Parties, investigation action under the FDC Act, the rules and regulations thereunder or comparable state laws, rules or regulations with respect to any products sold within the CCBCC Territory or (iii) undertaken any recall of products of the CCBCC Business within the CCBCC Territory that may have been adulterated, misbranded or otherwise made in violation of the FDC Act or the rules and regulations thereunder or comparable state laws, rules or regulations, except for recalls that have been reported to the US FDA and have been completed in accordance with US FDA’s requirements.

Product Recalls. (a) During the past three (3) years, there has not been, nor is there currently ongoing by any Seller the Company or any Affiliate of a Sellerthe Company, or to the Knowledge of the SellersSeller, any Governmental Authority, any recall or post-sale warning in respect of any product of the Business in the TerritoryCompany, except for recalls that have been reported to the U.S. Food and Drug Administration (the “US FDA”) and have been completed in accordance with the US FDA’s requirements. During the past three (3) years, none of neither the Sellers or their Company nor its Affiliates has received written notice of any material Action involving any product designed, manufactured, distributed or sold by or on behalf of the Business in the Territory Company resulting from an alleged defect in design or manufacture, any alleged hazard or impurity, or any alleged failure to warn, or from any alleged breach of implied warranties or representations, or any alleged noncompliance with any Laws, other than immaterial notices or claims that have been settled or resolved by the Sellers Company prior to the date of this Agreement. (b) None of the products designed, manufactured, distributed or sold by or on behalf of the Business Company have been adulterated or misbranded by the Sellers Company or their its Affiliates within the meaning of the Federal Food, Drug and Cosmetic Act, as amended (the “FDC Act”), or the rules or regulations issued thereunder or any comparable state law, rule or regulation in a manner that had a Material Adverse Effect or are articles that may not be introduced into interstate commerce under the provisions of Sections 404 or 505 of the FDC Act. No Seller or Neither the Company nor any Affiliate of any Seller the Company has, at any time during the past three (3) years, (i) received any written notice from the US FDA or from comparable state governmental or regulatory body of any material violation of the FDC Act or of comparable state laws, rules or regulations regarding any products sold by the Business within the TerritoryCompany, (ii) been the subject of any governmental or regulatory enforcement action or, to the Knowledge of the SellersSeller, investigation action under the FDC Act, the rules and regulations thereunder or comparable state laws, rules or regulations with respect to any products sold within by the Territory Company or (iii) undertaken any recall of products of the Business within the Territory Company that may have been adulterated, misbranded or otherwise made in violation of the FDC Act or the rules and regulations thereunder or comparable state lawsLaws, rules or regulations, except for recalls that have been reported to the US FDA and have been completed in accordance with US FDA’s requirements.

Product Recalls. (a) During the past three (3) years, there has not been, nor is there currently ongoing by any Seller CCR Party or any Affiliate of a SellerCCR Party, or to the Knowledge of the SellersCCR Parties, any Governmental Authority, any recall or post-sale warning in respect of any product of the Business in the TerritoryCCR Business, except for recalls that have been reported to the U.S. Food and Drug Administration (the “US FDA”) and have been completed in accordance with the US FDA’s requirements. During the past three (3) years, none of the Sellers CCR Parties or their Affiliates has received written notice of any material Action involving any product designed, manufactured, distributed or sold by or on behalf of the CCR Business in the Territory resulting from an alleged defect in design or manufacture, any alleged hazard or impurity, or any alleged failure to warn, or from any alleged breach of implied warranties or representations, or any alleged noncompliance with any Laws, other than immaterial notices or claims that have been settled or resolved by the Sellers CCR Parties prior to the date of this Agreement. (b) None of the products designed, manufactured, distributed or sold by or on behalf of the CCR Business have been adulterated or misbranded by the Sellers CCR Parties or their Affiliates within the meaning of the Federal Food, Drug and Cosmetic Act, as amended (the “FDC Act”), or the rules or regulations issued thereunder or any comparable state law, rule or regulation in a manner that had a CCR Material Adverse Effect or are articles that may not be introduced into interstate commerce under the provisions of Sections 404 or 505 of the FDC Act. No Seller CCR Party or Affiliate of any Seller CCR Party has, at any time during the past three (3) years, (i) received any written notice from the US FDA or from comparable state governmental or regulatory body of any material violation of the FDC Act or of comparable state laws, rules or regulations regarding any products sold by the Business within the TerritoryCCR Business, (ii) been the subject of any governmental or regulatory enforcement action or, to the Knowledge of the SellersCCR Parties, investigation action under the FDC Act, the rules and regulations thereunder or comparable state laws, rules or regulations with respect to any products sold within by the Territory CCR Business or (iii) undertaken any recall of products of the CCR Business within the Territory that may have been adulterated, misbranded or otherwise made in violation of the FDC Act or the rules and regulations thereunder or comparable state laws, rules or regulations, except for recalls that have been reported to the US FDA and have been completed in accordance with US FDA’s requirements.