Quality and Compliance. (i) the Specifications for all Products conform to all applicable cGMPs and Applicable Laws; (ii) on the date of shipment, the API will conform to the specifications for the API that Client has given to Patheon and that the API will be adequately contained, packaged, and labelled and will conform to the affirmations of fact on the container; (iii) the Products, if labelled and manufactured in accordance with the Specifications and in compliance with applicable cGMPs and Applicable Laws (i) may be lawfully sold and distributed in every jurisdiction in which Client markets the Products after separate approval, and (ii) to the knowledge of Client, will be safe for human consumption.
Appears in 4 contracts
Samples: Manufacturing Services Agreement (Horizon Therapeutics Public LTD Co), Manufacturing Services Agreement (Horizon Pharma PLC), Manufacturing Services Agreement (Horizon Pharma PLC)
Quality and Compliance. (i) the Specifications for all Products conform to all applicable cGMPs and Applicable Laws;
(ii) the Products, if labelled and manufactured in accordance with the Specifications and in compliance with applicable cGMPs and Applicable Laws (i) may be lawfully sold and distributed in every jurisdiction in which Client markets the Products, (ii) will be fit for the purpose intended, and (iii) will be safe for human consumption;
(iii) on the date of shipment, the API will conform to the specifications for the API that Client has given to Patheon and that the API will be adequately contained, packaged, and labelled and will conform to the affirmations of fact on the container;
(iii) the Products, if labelled and manufactured in accordance with the Specifications and in compliance with applicable cGMPs and Applicable Laws (i) may be lawfully sold and distributed in every jurisdiction in which Client markets the Products after separate approval, and (ii) to the knowledge of Client, will be safe for human consumption.
Appears in 4 contracts
Samples: Master Manufacturing Services Agreement (Neurocrine Biosciences Inc), Master Manufacturing Services Agreement (Horizon Pharma, Inc.), Master Manufacturing Services Agreement (Horizon Pharma, Inc.)
Quality and Compliance. (i) the Specifications for all Products conform the Product conforms to all applicable cGMPs cGMP and Applicable Laws;
(ii) the Product, if labelled and manufactured in accordance with the Specifications and in compliance with applicable cGMP and Applicable Laws (A) may be lawfully sold and distributed in the Territory, (B) will be fit for the purpose intended, and (C) will be safe for human consumption;
(iii) on the date of shipment, the API will conform to the specifications for the API that Client has given to Patheon and that the API will be adequately contained, packaged, and labelled and will conform to the affirmations of fact on the container;
(iii) the Products, if labelled and manufactured in accordance with the Specifications and in compliance with applicable cGMPs and Applicable Laws (i) may be lawfully sold and distributed in every jurisdiction in which Client markets the Products after separate approval, and (ii) to the knowledge of Client, will be safe for human consumption.
Appears in 3 contracts
Samples: Master Manufacturing Services Agreement, Master Manufacturing Services Agreement (Baudax Bio, Inc.), Master Manufacturing Services Agreement (Recro Pharma, Inc.)
Quality and Compliance. (i) the Specifications for all Products conform the Product conforms to all applicable cGMPs and Applicable Laws;
(ii) the Products, if labelled and manufactured in accordance with the Specifications and in compliance with applicable cGMPs and Applicable Laws (i) may be lawfully sold and distributed in every jurisdiction in which Client markets the Products, (ii) will be fit for the purpose intended, and (iii) will be safe for human consumption;
(iii) on the date of shipment, the API will conform to the specifications for the API that Client has given to Patheon and that the API will be adequately contained, packaged, and labelled and will conform to the affirmations of fact on the container;
(iii) the Products, if labelled and manufactured in accordance with the Specifications and in compliance with applicable cGMPs and Applicable Laws (i) may be lawfully sold and distributed in every jurisdiction in which Client markets the Products after separate approval, and (ii) to the knowledge of Client, will be safe for human consumption.
Appears in 3 contracts
Samples: Manufacturing Services Agreement (Evoke Pharma Inc), Manufacturing Services Agreement (Evoke Pharma Inc), Manufacturing Services Agreement (Evoke Pharma Inc)
Quality and Compliance. (i) the Specifications for all Products conform to all alt applicable cGMPs and Applicable Laws;
(ii) the Products, if labelled and manufactured in accordance with the Specifications and in compliance with applicable cGMPs and Applicable Laws (i) may be lawfully sold and distributed in every jurisdiction in which Client markets the Products, (ii) will be fit for the purpose intended, and (iii) will be safe for human consumption;
(iii) on the date of shipment, the API will conform to the specifications for the API that Client has given to Patheon and that the API will be adequately contained, packaged, and labelled and will conform to the affirmations of fact on the container;
(iii) the Products, if labelled and manufactured in accordance with the Specifications and in compliance with applicable cGMPs and Applicable Laws (i) may be lawfully sold and distributed in every jurisdiction in which Client markets the Products after separate approval, and (ii) to the knowledge of Client, will be safe for human consumption.
Appears in 3 contracts
Samples: Master Manufacturing Services Agreement (Osmotica Pharmaceuticals PLC), Master Manufacturing Services Agreement (Osmotica Pharmaceuticals LTD), Master Manufacturing Services Agreement (Osmotica Pharmaceuticals LTD)
Quality and Compliance. (i) the Specifications for all Products conform to all applicable cGMPs and Applicable Laws;
(ii) the Products, if labelled and manufactured in accordance with the Specifications and in compliance with applicable cGMPs and Applicable Laws (i) may be lawfully sold and distributed in every jurisdiction in which Client markets the Products, and (ii) will be fit for the purpose intended;
(iii) on the date of shipment, the API will conform to the specifications for the API that Client has given to Patheon and that the API will be adequately contained, packaged, and labelled and will conform to the affirmations of fact on the container;
(iii) the Products, if labelled and manufactured in accordance with the Specifications and in compliance with applicable cGMPs and Applicable Laws (i) may be lawfully sold and distributed in every jurisdiction in which Client markets the Products after separate approval, and (ii) to the knowledge of Client, will be safe for human consumption.
Appears in 2 contracts
Samples: Manufacturing Services Agreement (Santarus Inc), Manufacturing Services Agreement (Santarus Inc)
Quality and Compliance. (i) the Specifications for all Products Product conform to all applicable cGMPs and Applicable Laws;
(ii) on the date of shipment, the API will conform to the specifications for the API that Client has given to Patheon and that the API will be adequately contained, packaged, and labelled and will conform to the affirmations of fact on the container;
(iii) the ProductsProduct, if labelled and manufactured in accordance with the Specifications and in compliance with applicable cGMPs and Applicable Laws (i) may be lawfully sold and distributed in every jurisdiction in which Client markets the Products after separate approvalProduct, and (ii) will comply with the requirements of all applicable marketing approvals for the Product;
(iii) on the date of shipment, the API will conform to the knowledge of Client, specifications for the API that Client has given to Patheon and will be safe for human consumptionadequately contained, packaged, and labelled and will conform to the affirmations of fact on the container.
Appears in 2 contracts
Samples: Manufacturing Services Agreement (Acelrx Pharmaceuticals Inc), Manufacturing Services Agreement (Acelrx Pharmaceuticals Inc)
Quality and Compliance. (i) the Specifications for all Products conform to all applicable cGMPs and Applicable Laws;
(ii) on the date of shipment, the API will conform to the specifications for the API that Client has given to Patheon and that the API will be adequately contained, packaged, and labelled and will conform to the affirmations of fact on the container;
(iii) the Products, if labelled and manufactured in accordance with the Specifications and in compliance with applicable cGMPs and Applicable Laws (i) may be lawfully sold and distributed in every jurisdiction in which Client Indivior markets the Products after separate approvalProducts, (ii) will be fit for the purpose intended, and (iiiii) to the knowledge of Client, will be safe for human consumption;
(iii) on the date of shipment, the API will conform to the Specifications for the API that Indivior has given to Patheon and that the API will be adequately contained, packaged, and labelled and will conform to the affirmations of fact on the container.
Appears in 2 contracts
Samples: Master Manufacturing Services Agreement (Indivior PLC), Master Manufacturing Services Agreement (Indivior PLC)
Quality and Compliance. (i) the Specifications for all Products conform to all applicable cGMPs and Applicable Laws;
(ii) the Products, if labelled and manufactured in accordance with the Specifications and in compliance with applicable cGMPs and Applicable Laws (i) may be lawfully used, sold and distributed in every jurisdiction in which Client markets the Products; in accordance with the relevant Marketing Authorization, and (ii) will be sold by Client in a safe and responsible manner.
(iii) on the date of shipment, the API will conform to the specifications for the API that Client has given to Patheon and that the API will be adequately contained, packaged, and labelled and will conform to the affirmations of fact on the container;
(iii) the Products, if labelled and manufactured in accordance with the Specifications and in compliance with applicable cGMPs and Applicable Laws (i) may be lawfully sold and distributed in every jurisdiction in which Client markets the Products after separate approval, and (ii) to the knowledge of Client, will be safe for human consumption.
Appears in 2 contracts
Samples: Manufacturing Services Agreement, Manufacturing Services Agreement (Aptevo Therapeutics Inc.)
Quality and Compliance. (i) the Specifications for all Products conform to all applicable cGMPs and Applicable Laws;
(ii) on the date of shipment, the API will conform to the specifications for the API that Client has given to Patheon and that the API will be adequately contained, packaged, and labelled and will conform to the affirmations of fact on the container;
(iii) the Products, if labelled and manufactured in accordance with the Specifications and in compliance with applicable cGMPs and Applicable Laws (i) may be lawfully sold and distributed in every jurisdiction in which Client markets the Products after separate approvalProducts, (ii) will be fit for the purpose intended, and (iiiii) to the knowledge of Client, will be safe for human consumption; and
(iii) on the date of shipment to Patheon, the API will conform to the Specifications for the API that Client has given to Patheon and that the API will be adequately contained, packaged, and labelled and will conform to the affirmations of fact on the container.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Orexigen Therapeutics, Inc.)
Quality and Compliance. (i) the Specifications for all Products conform to all applicable cGMPs and Applicable Laws;
(ii) on the date of shipment, the API will conform to the specifications for the API that Client has given to Patheon and that the API will be adequately contained, packaged, and labelled and will conform to the affirmations of fact on the container;
(iii) the Products, if labelled and manufactured in accordance with the Specifications and in compliance with applicable cGMPs and Applicable Laws (i) may be lawfully sold and distributed in every jurisdiction in which Client PGx markets the Products after separate approvalProducts, (ii) will be fit for the purpose intended, and (iiiii) to the knowledge of Client, will be safe for human consumption;
(iii) on the date of shipment, the API will conform to the specifications for the API that PGx has given to Patheon and that the API will be adequately contained, packaged, and labelled and will conform to the affirmations of fact on the container.
Appears in 1 contract
Samples: Commercial Manufacturing Services Agreement (Clinical Data Inc)
Quality and Compliance. (i) the Specifications for all Products conform to all applicable cGMPs and Applicable Laws;
(ii) the Products, if labelled and manufactured in accordance with the Specification and in compliance with applicable cGMPs and Applicable Laws (i) may lawfully sold and distributed in every jurisdiction in which Client markets the Products, (ii) will be fit for the purpose intended, and
(iii) will be safe for hums consumption;
(iv) on the date of shipment, the API will conform to the specifications for the API that Client has given to Patheon and that the API will be adequately contained, contain& packaged, and labelled and will conform to the affirmations of fact on the container;
(iii) the Products, if labelled and manufactured in accordance with the Specifications and in compliance with applicable cGMPs and Applicable Laws (i) may be lawfully sold and distributed in every jurisdiction in which Client markets the Products after separate approval, and (ii) to the knowledge of Client, will be safe for human consumption.
Appears in 1 contract
Samples: Master Manufacturing Services Agreement (Horizon Therapeutics Public LTD Co)
Quality and Compliance. (i) the Specifications for all Products conform the Product conforms to all applicable cGMPs and Applicable Laws;
(ii) the Products, if labelled and manufactured by Patheon in accordance with the Specifications and in compliance with applicable cGMPs and Applicable Laws (A) may be lawfully sold and distributed in the Territory, (B) will be fit for the purpose intended, and (C) will be safe for human consumption;
(iii) on the date of shipment, the API will conform to the specifications for the API that Client has given to Patheon and that the API will be adequately contained, packaged, and labelled and will conform to the affirmations of fact on the container;
(iii) the Products, if labelled and manufactured in accordance with the Specifications and in compliance with applicable cGMPs and Applicable Laws (i) may be lawfully sold and distributed in every jurisdiction in which Client markets the Products after separate approval, and (ii) to the knowledge of Client, will be safe for human consumption.
Appears in 1 contract
Samples: Master Manufacturing Services Agreement (TESARO, Inc.)
Quality and Compliance. (ie) the Specifications for all Products conform to all applicable cGMPs and Applicable Laws;; and
(ii) on the date of shipment, the API will conform to the specifications for the API that Client has given to Patheon and that the API will be adequately contained, packaged, and labelled and will conform to the affirmations of fact on the container;
(iiif) the Products, if labelled and manufactured in accordance with the Specifications and in compliance with applicable cGMPs and Applicable Laws (i) may be lawfully sold and distributed in every jurisdiction in which Client Customer markets such Products, (ii) will be fit for the Products after separate approvalpurpose intended, and (iiiii) to the knowledge of Client, will be safe for human consumption.
(g) the Customer represents and warrants that, on the date of shipment, the API will conform to the specifications for the API that Customer has provided to Patheon. The Customer further warrants that the API will be adequately contained, packaged and labelled and will conform to the affirmations of fact on the container.
Appears in 1 contract
Quality and Compliance. (ia) the Specifications for all Products conform to all applicable cGMPs and Applicable Laws;; and
(ii) on the date of shipment, the API will conform to the specifications for the API that Client has given to Patheon and that the API will be adequately contained, packaged, and labelled and will conform to the affirmations of fact on the container;
(iiib) the Products, if labelled and manufactured in accordance with the Specifications and in compliance with applicable cGMPs and Applicable Laws (i) may be lawfully sold and distributed in every jurisdiction in which Client markets the Products after separate approvalTerritory where appropriate regulatory authorization has been granted, (ii) will be fit for the purpose intended, and (iiiii) to the knowledge of Client, will be safe for human consumption.
(c) Éclat represents and warrants that, on the date of receipt by Patheon, the API will conform to the specifications for the API that Éclat has provided to Patheon. Éclat further warrants that the API will be adequately contained, packaged and labelled and will conform to the affirmations of fact on the container.
Appears in 1 contract
Samples: Master Manufacturing Services Agreement (Avadel Pharmaceuticals PLC)