Common use of Manufacturing Quality; Storage Clause in Contracts

Manufacturing Quality; Storage. All Product shall be Manufactured by ULURU at the Facility using Materials and processing aids free of animal derived materials. ULURU shall sample and analyze all Materials upon receipt to ensure that such Materials are unadulterated, free of defects and meet the applicable Specifications therefor. ULURU shall take all necessary steps to prevent contamination and cross contamination of Product. The Product shall be unadulterated and free from contamination, dilutents and foreign matter in any amount in accordance with the Product specifications and generally accepted pharmaceutical standards. ULURU shall perform the quality control tests (both when the Product is in-process and when it is finished) with respect to the Product in accordance with the Methods of Analysis. ULURU shall promptly, upon completion of such tests, deliver to ORADISC a copy of the record of such tests performed on, and a Certificate of Analysis for, each Batch of Product. Within thirty (30) days of the Effective Date, each of the Parties shall execute and deliver the Quality Agreement substantially in the form of Exhibit B and as mutually agreed to by the parties. Each Party agrees to perform its respective obligations under the Quality Agreement in accordance with such agreement. Prior to shipment, the Product shall be stored at all times in conditions at least as favorable as those set forth on the Product’s label, or in accordance with conditions reasonably specified by ORADISC.

Appears in 1 contract

Samples: License and Supply Agreement (Uluru Inc.)

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Manufacturing Quality; Storage. All Product shall be Manufactured by ULURU at the Facility using Materials and processing aids free of animal derived materials. ULURU shall sample and analyze all Materials upon receipt to ensure that such Materials are unadulterated, free of defects and meet the applicable Specifications therefor. , ULURU shall take all necessary steps to prevent contamination and cross contamination of Product. The Product shall be unadulterated and free from contamination, dilutents and foreign matter in any amount in accordance with the Product specifications and generally accepted pharmaceutical standards. ULURU shall perform the quality control tests (both when the Product is in-process and when it is finished) with respect to the Product in accordance with the Methods of Analysis. ULURU shall promptly, upon completion of such tests, deliver to ORADISC ALTRAZEAL a copy of the record of such tests performed on, and a Certificate of Analysis for, each Batch of Product. Within thirty (30) days of the Effective Date, each of the Parties shall execute and deliver the Quality Agreement substantially in the form of Exhibit B and as mutually agreed to by the parties. Each Party agrees to perform its respective obligations under the Quality Agreement in accordance with such agreement. Prior to shipment, the Product shall be stored at all times in conditions at least as favorable as those set forth on the Product’s 's label, or in accordance with conditions reasonably specified by ORADISCALTRAZEAL.

Appears in 1 contract

Samples: Exclusive License and Supply Agreement (Uluru Inc.)

Manufacturing Quality; Storage. All Product shall be Manufactured by ULURU ACCESS at the Facility using Materials and processing aids free of animal derived materials. ULURU ACCESS shall sample and analyze all Materials upon receipt to ensure that such Materials are unadulterated, free of defects and meet the applicable Specifications therefor. ULURU ACCESS shall take all necessary steps to prevent contamination and cross contamination of Product. The Product shall be unadulterated and free from contamination, dilutents and foreign matter in any amount in accordance with the Product specifications and generally accepted pharmaceutical standards. ULURU ACCESS shall perform the quality control tests (both when the Product is in-process and when it is finished) with respect to the Product in accordance with the Methods of Analysis, the cost of such to be included in the price hereinafter specified. ULURU ACCESS shall promptly, upon completion of such tests, deliver to ORADISC WYETH a copy of the record of such tests performed on, and a Certificate of Analysis for, each Batch of Product. ACCESS shall deliver a representative sample from each Batch of Product to WYETH's designated representative by the date reasonably specified by such representative. Within thirty (30) days of the Effective Date, each of the Parties shall execute and deliver the Quality Agreement substantially in the form of Exhibit B C and as mutually agreed to by the parties. Each Party agrees to perform its respective obligations under the Quality Agreement in accordance with such agreement. Prior to shipment, the Product shall be stored at all times in conditions at least as favorable as those set forth on the Product’s 's label, or in accordance with conditions reasonably specified by ORADISCWYETH.

Appears in 1 contract

Samples: License and Supply Agreement (Access Pharmaceuticals Inc)

Manufacturing Quality; Storage. All Product shall be Manufactured by ULURU at the Facility using Materials and processing aids free of animal derived materials. ULURU shall sample and analyze all Materials upon receipt to ensure that such Materials are unadulterated, free of defects and meet the applicable Specifications therefor. ULURU shall take all necessary steps to prevent contamination and cross contamination of Product. The Product shall be unadulterated and free from contamination, dilutents and foreign matter in any amount in accordance with the Product specifications and generally accepted pharmaceutical standards. ULURU shall perform the quality control tests (both when the Product is in-process and when it is finished) with respect to the Product in accordance with the Methods of Analysis. ULURU shall promptly, upon completion of such tests, deliver to ORADISC MXXXXX HOLDING a copy of the record of such tests performed on, and a Certificate of Analysis for, each Batch of Product. Within thirty (30) days of the Effective Date, each of the Parties shall execute and deliver the Quality Agreement substantially in the form of Exhibit B and as mutually agreed to by the parties. Each Party agrees to perform its respective obligations under the Quality Agreement in accordance with such agreement. Prior to shipment, the Product shall be stored at all times in conditions at least as favorable as those set forth on the Product’s label, or in accordance with conditions reasonably specified by ORADISCMXXXXX HOLDING.

Appears in 1 contract

Samples: License and Supply Agreement (Uluru Inc.)

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Manufacturing Quality; Storage. All Product shall be Manufactured by ULURU ULURU’s contract manufacturer at the Facility using Materials and processing aids free of animal derived materials. ULURU shall sample and analyze all Materials upon receipt to ensure that such Materials are unadulterated, free of defects and meet the applicable Specifications therefor. ULURU shall take all necessary steps to prevent contamination and cross contamination of Product. The Product shall be unadulterated and free from contamination, dilutents and foreign matter in any amount in accordance with the Product specifications and generally accepted pharmaceutical standards. ULURU shall perform the quality control tests (both when the Product is in-process and when it is finished) with respect to the Product in accordance with the Methods of Analysis, the cost of such to be included in the price hereinafter specified. ULURU shall promptly, upon completion of such tests, deliver to ORADISC DEXO a copy of the record of such tests performed on, and a Certificate of Analysis for, each Batch of Product. ULURU shall deliver a representative sample from each Batch of Product to DEXO’s designated representative by the date reasonably specified by such representative. Within thirty (30) days of the Effective Date, each of the Parties shall execute and deliver the Quality Agreement substantially in the form of Exhibit B and as mutually agreed to by the parties. Each Party agrees to perform its respective obligations under the Quality Agreement in accordance with such agreement. Prior to shipment, the Product shall be stored at all times in conditions at least as favorable as those set forth on the Product’s label, or in accordance with conditions reasonably specified by ORADISCDEXO.

Appears in 1 contract

Samples: License and Supply Agreement (Uluru Inc.)

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