Common use of Manufacturing Quality Clause in Contracts

Manufacturing Quality. (a) Except for Approved CFCs supplied by WYETH for Manufacture under Option A, XXXXXXXXX shall obtain all Materials from WYETH approved suppliers and shall pay such suppliers on a timely and current basis. All Product shall be Manufactured by XXXXXXXXX at the Facility using Materials and processing aids free of animal derived materials. XXXXXXXXX shall meet all applicable Regulatory Requirements and WYETH Requirements for the Manufacture of the Product, including but not limited to, the requirements set forth in the agreed upon Quality Agreement. On the Effective Date or promptly thereafter, the Parties shall execute and deliver to each other the Quality Agreement substantially in the form of Exhibit C. Each Party agrees to perform its respective obligations under the Quality Agreement in accordance with such agreement. (b) XXXXXXXXX shall sample and analyze all Materials upon receipt to ensure that such Materials are free of defects and meet the applicable Specifications therefor. XXXXXXXXX shall take all necessary steps to prevent contamination and cross contamination of Product. Product shall be unadulterated and free from contamination, diluents and foreign matter in any amount. XXXXXXXXX shall perform the quality control tests with respect to Product in accordance with the Specifications using the Methods of Analysis, the cost of the same to be included in the price hereinafter specified. XXXXXXXXX shall promptly, upon completion of such tests, deliver to WYETH a copy of the record of such tests performed on, and a Certificate of Analysis for, each Batch of Product. Upon request, XXXXXXXXX shall deliver a representative sample from each Batch of Product to WYETH's designated representative by the date and in the manner specified by such representative. XXXXXXXXX shall pay the costs of shipping such samples to WYETH's representative if such costs are below Twenty Five Dollars ($25) per shipment. Otherwise, XXXXXXXXX shall invoice WYETH for shipping costs.

Manufacturing Quality. (a) Except for Approved CFCs supplied by WYETH for Manufacture under Option A, XXXXXXXXX Storage. ACCESS shall obtain all Materials from WYETH approved suppliers and shall pay such suppliers on a timely and current basis. All Product shall be Manufactured by XXXXXXXXX at the Facility using Materials and processing aids free of animal derived materials. XXXXXXXXX shall meet all applicable Regulatory Requirements and WYETH Requirements for the Manufacture of the Product, including but not limited to, the requirements set forth in the agreed upon Quality Agreement. On the Effective Date ensure that ACCESS or promptly thereafter, the Parties shall execute and deliver to each other the Quality Agreement substantially in the form of Exhibit C. Each ACCESS’s Third Party agrees to perform its respective obligations under the Quality Agreement in accordance with such agreement. (b) XXXXXXXXX Manufacturers shall sample and analyze all Materials upon receipt to ensure that such Materials are free unadulterated. Free of defects and meet the applicable Specifications thereforspecifications therefore. XXXXXXXXX ACCESS shall take all necessary steps to attempt to prevent contamination and cross contamination of ProductProducts. Product The Products shall be delivered to DISCUS in fully finished form and in their final, FDA-approved packaging configuration(s), including all applicable labeling and package inserts, and with a minimum shelf-life remaining for each lot of Product delivered therein to DISCUS of three months less than the approved shelf life. All Products Manufactured by ACCESS shall be certified by ACCESS. ACCESS shall or shall cause ACCESS’s Third Party Manufacturers to (i) meet the standards for identity, quality, safety, strength and purity of the ingredients as specified in the approved New Drug Application for Products, and that the Products and their raw materials were handled and manufactured such that they meet FDA standards for identity and purity of the Product as specified in the approved New Drug Application for the Product, (ii) certify that each lot of Product has been manufactured in full compliance with Good-Manufacturing Practices (GMP)/Good Laboratory Practices (GLP) and all ISO regulations applicable to the manufacture, testing and release of pharmaceuticals, and certify that each lot of Product is unadulterated and free from contamination, diluents dilutents and foreign matter in any amount. XXXXXXXXX shall amount in accordance with the Products specifications and generally accepted pharmaceutical standards, (iii) perform the quality control tests (both when the Products are in-process and when they are finished) with respect to Product the Products in accordance with the Specifications using the Methods of Analysis, the cost of the same such to be included in the price hereinafter specified. XXXXXXXXX , and shall promptly, upon completion of such tests, deliver to WYETH a copy of the record of such tests performed on, and DISCUS a Certificate of Analysis for, for each Batch of Product. Upon request, XXXXXXXXX shall Products which lists the results of such tests and demonstrates that the products meet identify and purity standards approved by the FDA in ‘s approved New Drug Application for the Product and (v) deliver a representative sample from each Batch of Product Products to WYETH's DISCUS’s designated representative by at the date and in the manner specified by such representative. XXXXXXXXX shall pay the costs of shipping such samples same time each batch is delivered to WYETH's representative if such costs are below Twenty Five Dollars ($25) per shipment. Otherwise, XXXXXXXXX shall invoice WYETH for shipping costsDISCUS.

Manufacturing Quality. (a) Except for Approved CFCs supplied by WYETH for Manufacture under Option A, XXXXXXXXX IMPAX shall obtain all Materials from WYETH WCH approved suppliers and shall pay such suppliers on a timely and current basissuppliers. All Product Products shall be Manufactured by XXXXXXXXX at the Facility using and in accordance with GMPs. IMPAX shall sample and analyze all Materials and processing aids upon receipt to ensure that such Materials are free of animal derived materialsdefects and meet the applicable specifications therefor. XXXXXXXXX Until WCH notifies IMPAX in writing that such practice may be suspended or discontinued, IMPAX shall meet all applicable Regulatory Requirements and WYETH Requirements for provide samples from each batch of Loratadine to be used in the Manufacture of any Product and samples from each Batch of Product to XXXXX (or such other contract laboratory specified by WCH) to perform the Identity Testing to ensure that such Loratadine and Product, including but as the case may be, meet the Identity Criteria. IMPAX shall promptly provide WCH with the results of such Identity Tests. XXXXX (or such other laboratory specified by WCH) shall xxxx WCH directly for such services, and such amounts shall not limited tobe included in Direct Manufacturing Cost. IMPAX shall not use any Loratadine in the Manufacture of Product that does not meet the Identity Criteria and shall not ship any Product to WCH that does not meet the Identity Criteria. IMPAX shall take all necessary steps to prevent contamination and cross contamination of Products. Products shall be unadulterated (within the meaning of the FD&C Act) and free from contamination, diluents and foreign matter in any amount. IMPAX shall perform the quality control tests with respect to Products in accordance with the Methods of Analysis, the requirements set forth cost of the same to be included in the agreed price hereinafter specified. IMPAX shall promptly, upon Quality Agreementcompletion of such tests, deliver to WCH a copy of the record of such tests performed on, and a Certificate of Analysis for, each Batch of Product. At WCH’s request, IMPAX shall deliver a representative sample (in the same amount as the sample that IMPAX retains for its own purposes) from each Batch of Product to WCH’s designated representative. On the Effective Date or promptly thereafter, the Parties shall execute and deliver to each other the Quality Agreement substantially in the form of Exhibit C. Each Party agrees to perform its respective obligations under the Quality Agreement in accordance with such agreement. (b) XXXXXXXXX shall sample and analyze all Materials upon receipt to ensure that such Materials are free of defects and meet the applicable Specifications therefor. XXXXXXXXX shall take all necessary steps to prevent contamination and cross contamination of Product. Product shall be unadulterated and free from contamination, diluents and foreign matter in any amount. XXXXXXXXX shall perform the quality control tests with respect to Product in accordance with the Specifications using the Methods of Analysis, the cost of the same to be included in the price hereinafter specified. XXXXXXXXX shall promptly, upon completion of such tests, deliver to WYETH a copy of the record of such tests performed on, and a Certificate of Analysis for, each Batch of Product. Upon request, XXXXXXXXX shall deliver a representative sample from each Batch of Product to WYETH's designated representative by the date and in the manner specified by such representative. XXXXXXXXX shall pay the costs of shipping such samples to WYETH's representative if such costs are below Twenty Five Dollars ($25) per shipment. Otherwise, XXXXXXXXX shall invoice WYETH for shipping costs.

Manufacturing Quality. (a) Except for Approved CFCs supplied by WYETH for Manufacture the development activities to be conducted under Option Athe Program, XXXXXXXXX shall obtain all Materials from WYETH approved suppliers the sharing of Program Information under this Agreement, and shall pay such suppliers on a timely and current basis. All Product shall be Manufactured by XXXXXXXXX at the Facility using Materials and processing aids free of animal derived materials. XXXXXXXXX shall meet all applicable Regulatory Requirements and WYETH Requirements for the Manufacture provision of the Product, including but not limited to, development supply of the requirements set forth in the agreed upon Quality Agreement. On the Effective Date or promptly thereafter, the Parties shall execute and deliver Drug and/or Product by Xenova to each other the Quality Agreement substantially in the form of Exhibit C. Each Party agrees to perform its respective obligations under the Quality Agreement QLT in accordance with such agreementSection 3.2, QLT and Xenova will each be responsible for the qualification and validation of their respective Drug and/or Product manufacturers' facilities to GMPs for the manufacture and processing of the Drug and/or the Product. (b) XXXXXXXXX Each party shall sample and analyze all Materials upon receipt use commercially reasonable efforts to ensure that any Person with whom it contracts for the manufacture and processing of the Drug and/or the Product for clinical or commercial use shall undertake to comply with the following requirements: (i) all manufacturing and processing activities shall be conducted in a competent fashion and in accordance with GMPs, any quality system agreement executed by the parties, the applicable specification and the applicable validation protocol or master batch record, as the case may be; (ii) all manufacturing facilities, equipment, utilities and systems used for the manufacture and processing of the Drug and/or the Product shall comply with GMPs or GLPs, as applicable, including installation qualification and operational qualification requirements, requirements for environmental monitoring in manufacturing areas and requirements relating to the conveyance of bulk materials within such Materials facilities; (iii) all analytical work shall be performed in a manner and in a laboratory which complies with GMPs and all related testing procedures and equipment shall be validated prior to use; (iv) all personnel furnished to perform the work shall be qualified to perform the tasks and functions which they are assigned; (v) all Drug and/or Product manufactured or processed shall satisfy the applicable specification as at the date of delivery; (vi) all Finished Product manufactured or processed, and any other batch of the Product designated in advance as a batch to be used as clinical or commercial supplies, shall be merchantable, free of from defects and meet shall not be adulterated or misbranded within the applicable Specifications therefor. XXXXXXXXX meaning of the Act, or any equivalent legislation in any jurisdiction in which the Finished Product is to be marketed and sold; (vii) all Drug and/or Product manufactured or processed shall take be delivered free and clear of any security interests, liens, claims, pledges or encumbrances of any kind or nature; (viii) all necessary steps to prevent contamination transportation and cross contamination storage of Product. raw materials, Drug and Product shall be unadulterated performed in compliance with GMPs and free from contamination, diluents and foreign matter in any amount. XXXXXXXXX shall perform the quality control tests with respect to Product in accordance with the Specifications using applicable specification, any applicable quality system agreement and applicable shipping instructions; (ix) all manufacturing and processing activities, including waste disposal, shall be performed in accordance with applicable United States of America and other foreign federal, state, provincial and local laws, regulations and bylaws, including, without limitation, all environmental laws; (x) all applicable licenses, permits, certificates, authorizations or approvals from all applicable United States of America and other foreign federal, state, provincial, local and other authorities necessary to conduct its business and manufacture, package, label, ship, export, import and deliver the Methods Drug and/or the Product shall have been obtained and shall be maintained in full force and effect; (xi) appropriate records and reports shall be recorded and maintained and shall be accurate and complete in all material respects; and (xii) no Intellectual Property of Analysis, any Third Party shall be used in the cost manufacture and processing of the same to be included in Drug and/or the price hereinafter specified. XXXXXXXXX shall promptlyProduct, upon completion except with prior written consent of such tests, deliver to WYETH a copy of the record of such tests performed on, and a Certificate of Analysis for, each Batch of Product. Upon request, XXXXXXXXX shall deliver a representative sample from each Batch of Product to WYETH's designated representative by the date and in the manner specified by such representative. XXXXXXXXX shall pay the costs of shipping such samples to WYETH's representative if such costs are below Twenty Five Dollars ($25) per shipment. Otherwise, XXXXXXXXX shall invoice WYETH for shipping costsThird Party.

Manufacturing Quality. (a) Except for Approved CFCs supplied by WYETH for Manufacture under Option A, XXXXXXXXX IMPAX shall obtain all Materials from WYETH WCH approved suppliers and shall pay such suppliers on a timely and current basissuppliers. All Product Products shall be Manufactured by XXXXXXXXX at the Facility using and in accordance with GMPs. IMPAX shall sample and analyze all Materials and processing aids upon receipt to ensure that such Materials are free of animal derived materialsdefects and meet the applicable specifications therefor. XXXXXXXXX Until WCH notifies IMPAX in writing that such practice may be suspended or discontinued, IMPAX shall meet all applicable Regulatory Requirements and WYETH Requirements for provide samples from each batch of Loratadine to be used in the Manufacture of any Product and samples from each Batch of Product to ++ (or such other contract laboratory specified by WCH) to perform the ++ to ensure that such Loratadine and Product, including but as the case may be, meet the ++. IMPAX shall promptly provide WCH with the results of such ++. ++ (or such other laboratory specified by WCH) shall xxxx WCH directly for such services, and such amounts shall not limited tobe included in Direct Manufacturing Cost. IMPAX shall not use any Loratadine in the Manufacture of Product that does not meet the ++ and shall not ship any Product to WCH that does not meet the ++. IMPAX shall take all necessary steps to prevent contamination and cross contamination of Products. Products shall be unadulterated (within the meaning of the FD&C Act) and free from contamination, diluents and foreign matter in any amount. IMPAX shall perform the quality control tests with respect to Products in accordance with the Methods of Analysis, the requirements set forth cost of the same to be included in the agreed price hereinafter specified. IMPAX shall promptly, upon Quality Agreementcompletion of such tests, deliver to WCH a copy of the record of such tests performed on, and a Certificate of Analysis for, each Batch of Product. At WCH's request, IMPAX shall deliver a representative sample (in the same amount as the sample that IMPAX retains for its own purposes) from each Batch of Product to WCH's designated representative. On the Effective Date or promptly thereafter, the Parties shall execute and deliver to each other the Quality Agreement substantially in the form of Exhibit C. Each Party agrees to perform its respective obligations under the Quality Agreement in accordance with such agreement. (b) XXXXXXXXX shall sample . ---------------- ++ Confidential portions omitted and analyze all Materials upon receipt to ensure that such Materials are free of defects and meet the applicable Specifications therefor. XXXXXXXXX shall take all necessary steps to prevent contamination and cross contamination of Product. Product shall be unadulterated and free from contamination, diluents and foreign matter in any amount. XXXXXXXXX shall perform the quality control tests with respect to Product in accordance filed separately with the Specifications using the Methods of Analysis, the cost of the same to be included in the price hereinafter specified. XXXXXXXXX shall promptly, upon completion of such tests, deliver to WYETH a copy of the record of such tests performed on, and a Certificate of Analysis for, each Batch of Product. Upon request, XXXXXXXXX shall deliver a representative sample from each Batch of Product to WYETH's designated representative by the date and in the manner specified by such representative. XXXXXXXXX shall pay the costs of shipping such samples to WYETH's representative if such costs are below Twenty Five Dollars ($25) per shipment. Otherwise, XXXXXXXXX shall invoice WYETH for shipping costsCommission.

Manufacturing Quality. (a) Except for Approved CFCs supplied by WYETH for Manufacture under Option A, XXXXXXXXX IMPAX shall obtain all Materials from WYETH WCH approved suppliers and shall pay such suppliers on a timely and current basissuppliers. All Product Products shall be Manufactured by XXXXXXXXX at the Facility using and in accordance with GMPs. IMPAX shall sample and analyze all Materials and processing aids upon receipt to ensure that such Materials are free of animal derived materialsdefects and meet the applicable specifications therefor. XXXXXXXXX Until WCH notifies IMPAX in writing that such practice may be suspended or discontinued, IMPAX shall meet all applicable Regulatory Requirements and WYETH Requirements for provide samples from each batch of Loratadine to be used in the Manufacture of any Product and samples from each Batch of Product to [XXXXXX]* (or such other contract laboratory specified by WCH) to perform the Identity Testing to ensure that such Loratadine and Product, including but as the case may be, meet the Identity Criteria. IMPAX shall promptly provide WCH with the results of such Identity Tests. [XXXXXX]* (or such other laboratory specified by WCH) shall xxxx WCH directly for such services, and such amounts shall not limited tobe included in Direct Manufacturing Cost. IMPAX shall not use any Loratadine in the Manufacture of Product that does not meet the Identity Criteria and shall not ship any Product to WCH that does not meet the Identity Criteria. IMPAX shall take all necessary steps to prevent contamination and cross contamination of Products. Products shall be unadulterated (within the meaning of the FD&C Act) and free from contamination, diluents and foreign matter in any amount. IMPAX shall perform the quality control tests with respect to Products in accordance with the Methods of Analysis, the requirements set forth cost of the same to be included in the agreed price hereinafter specified. IMPAX shall promptly, upon Quality Agreementcompletion of such tests, deliver to WCH a copy of the record of such tests performed on, and a Certificate of Analysis for, each Batch of Product. At WCH's request, IMPAX shall deliver a representative sample (in the same amount as the sample that IMPAX retains for its own purposes) from each Batch of Product to WCH's designated representative. On the Effective Date or promptly thereafter, the Parties shall execute and deliver to each other the Quality Agreement substantially in the form of Exhibit C. Each Party agrees to perform its respective obligations under the Quality Agreement in accordance with such agreement. (b) XXXXXXXXX shall sample and analyze all Materials upon receipt to ensure that such Materials are free of defects and meet the applicable Specifications therefor. XXXXXXXXX shall take all necessary steps to prevent contamination and cross contamination of Product. Product shall be unadulterated and free from contamination, diluents and foreign matter in any amount. XXXXXXXXX shall perform the quality control tests with respect to Product in accordance with the Specifications using the Methods of Analysis, the cost of the same to be included in the price hereinafter specified. XXXXXXXXX shall promptly, upon completion of such tests, deliver to WYETH a copy of the record of such tests performed on, and a Certificate of Analysis for, each Batch of Product. Upon request, XXXXXXXXX shall deliver a representative sample from each Batch of Product to WYETH's designated representative by the date and in the manner specified by such representative. XXXXXXXXX shall pay the costs of shipping such samples to WYETH's representative if such costs are below Twenty Five Dollars ($25) per shipment. Otherwise, XXXXXXXXX shall invoice WYETH for shipping costs.

Manufacturing Quality. (a) Except for Approved CFCs supplied by WYETH for Manufacture under Option A, XXXXXXXXX IMPAX shall obtain all Materials from WYETH WCH approved suppliers and shall pay such suppliers on a timely and current basissuppliers. All Product Products shall be Manufactured by XXXXXXXXX at the Facility using and in accordance with GMPs. IMPAX shall sample and analyze all Materials and processing aids upon receipt to ensure that such Materials are free of animal derived materialsdefects and meet the applicable specifications therefor. XXXXXXXXX Until WCH notifies IMPAX in writing that such practice may be suspended or discontinued, IMPAX shall meet all applicable Regulatory Requirements and WYETH Requirements for provide samples from each batch of Loratadine to be used in the Manufacture of any Product and samples from each Batch of Product to SSCI, Inc. (or such other contract laboratory specified by WCH) to perform the Identity Testing to ensure that such Loratadine and Product, including but as the case may be, meet the Identity Criteria. IMPAX shall promptly provide WCH with the results of such Identity Tests. SSCI, Inc. (or such other laboratory specified by WCH) shall xxxx WCH directly for such services, and such amounts shall not limited tobe included in Direct Manufacturing Cost. IMPAX shall not use any Loratadine in the Manufacture of Product that does not meet the Identity Criteria and shall not ship any Product to WCH that does not meet the Identity Criteria. IMPAX shall take all necessary steps to prevent contamination and cross contamination of Products. Products shall be unadulterated (within the meaning of the FD&C Act) and free from contamination, diluents and foreign matter in any amount. IMPAX shall perform the quality control tests with respect to Products in accordance with the Methods of Analysis, the requirements set forth cost of the same to be included in the agreed price hereinafter specified. IMPAX shall promptly, upon Quality Agreementcompletion of such tests, deliver to WCH a copy of the record of such tests performed on, and a Certificate of Analysis for, each Batch of Product. At WCH’s request, IMPAX shall deliver a representative sample (in the same amount as the sample that IMPAX retains for its own purposes) from each Batch of Product to WCH’s designated representative. On the Effective Date or promptly thereafter, the Parties shall execute and deliver to each other the Quality Agreement substantially in the form of Exhibit C. Each Party agrees to perform its respective obligations under the Quality Agreement in accordance with such agreement. (b) XXXXXXXXX shall sample and analyze all Materials upon receipt to ensure that such Materials are free of defects and meet the applicable Specifications therefor. XXXXXXXXX shall take all necessary steps to prevent contamination and cross contamination of Product. Product shall be unadulterated and free from contamination, diluents and foreign matter in any amount. XXXXXXXXX shall perform the quality control tests with respect to Product in accordance with the Specifications using the Methods of Analysis, the cost of the same to be included in the price hereinafter specified. XXXXXXXXX shall promptly, upon completion of such tests, deliver to WYETH a copy of the record of such tests performed on, and a Certificate of Analysis for, each Batch of Product. Upon request, XXXXXXXXX shall deliver a representative sample from each Batch of Product to WYETH's designated representative by the date and in the manner specified by such representative. XXXXXXXXX shall pay the costs of shipping such samples to WYETH's representative if such costs are below Twenty Five Dollars ($25) per shipment. Otherwise, XXXXXXXXX shall invoice WYETH for shipping costs.