Certain Prohibitions. Adolor shall not, and the Existing Product Suppliers have agreed not to, manufacture, store or process any API Compound or Product in the same building in which Adolor, or its Product Suppliers, as the case may be, manufactures, stores or processes genotoxics, penicillins, genetically modified organisms, cephalosporins, sex hormones, anabolic steroids, and infectious agents (e.g., spore-bearing and live viruses), (collectively, “Potential Contaminants”) unless the Potential Contaminants are stored or manufactured in contained environments and in compliance with cleaning, validation and changeover standards of all cGMPs and all applicable Laws. Adolor shall promptly notify GSK as soon as Adolor has knowledge that any of the Potential Contaminants are to be manufactured, processed or stored in any portion of a facility which may result in the introduction of Potential Contaminants into the areas of a facility where Adolor, or its Product Suppliers, as the case may be, manufactures, processes or stores API Compound or Products. Adolor shall notify GSK promptly after Adolor has knowledge of such event, if Adolor, or its Product Suppliers, as applicable, intend to change the nature or use of any portion of a facility or any module to include the use of any of the Potential Contaminants. The Existing Product Suppliers have agreed to not make such changes if the change could reasonably be expected to result in a material adverse effect on the ability to fully perform the obligations under this Agreement and Adolor has not demonstrated to GSK’s reasonable satisfaction that such Potential Contaminants shall be completely segregated from the Products at all times.
Appears in 1 contract
Sources: Row Supply Agreement (Adolor Corp)
Certain Prohibitions. Adolor PII shall not, and the Existing Product Suppliers have agreed not to, manufacture, store or process any API Compound or Drug Product in the same building in which Adolor, or its Product Suppliers, as the case may be, PII manufactures, stores or processes genotoxics, penicillins, genetically modified organisms, cephalosporins, sex hormones, anabolic steroids, and infectious agents (e.g., spore-bearing and live viruses), (collectively, “Potential Contaminants”) unless the Potential Contaminants are stored or manufactured in contained environments and in compliance with cleaning, validation and changeover standards of all cGMPs and all applicable Laws; provided, however, Adolor acknowledges that as of the Effective Date, PII is manufacturing the Potential Contaminants set forth on Schedule 3.5.2 at the Facility. Adolor PII shall promptly notify GSK as soon as Adolor has knowledge that if any of the Potential Contaminants are to be manufactured, processed or stored in any portion of a facility the Facility which may would result in the introduction of Potential Contaminants into the areas of a facility the Facility where Adolor, or its Product Suppliers, as the case may be, PII manufactures, processes or stores API Compound or Productsthe Drug Product. Adolor PII shall notify GSK promptly after Adolor has by not later than the earlier to occur of (i) sixty (60) days prior to such event or (ii) PII’s knowledge of such event, if Adolor, or its Product Suppliers, as applicable, intend PII intends to change the nature or use of any portion of a facility or any module the Facility to include the use of any of the Potential ContaminantsContaminants other than those set forth on Schedule 3.5.2. The Existing Product Suppliers have agreed to PII shall not make such changes if the change could reasonably be expected to result in a material adverse effect on the ability to fully perform the obligations under this Agreement and Adolor PII has not demonstrated to GSKAdolor’s reasonable satisfaction that such Potential Contaminants shall be completely segregated from the Products Drug Product at all timestimes consistent with current practices and shall comply with all Regulatory Standards.
Appears in 1 contract
Certain Prohibitions. Adolor shall Patheon will not, and the Existing Product Suppliers have agreed not toas applicable, manufacture, store or process any API Compound Materials or Product in the same building in which Adolor, or its Product Suppliers, as the case may be, Patheon manufactures, stores or processes genotoxics, penicillins, genetically modified organisms, cephalosporins, sex hormones, anabolic steroids, and infectious agents (e.g., spore-bearing and live viruses), processes[ * ] (collectively, “Potential Contaminants”) unless the Potential Contaminants are stored or manufactured in contained environments and in [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. compliance with cleaning, validation and changeover standards of all cGMPs the Quality Agreement, cGMPs, and all applicable Laws. Adolor shall Patheon will promptly notify GSK as soon as Adolor has knowledge that XenoPort if any of the Potential Contaminants are to may be manufactured, processed or stored in any portion of a facility which may result in the introduction of Potential Contaminants introduced into the areas of a facility same building on the Facility where Adolor, or its Product Suppliers, as the case may be, Patheon manufactures, processes or stores API Compound Materials or Products. Adolor shall Patheon will notify GSK promptly after Adolor has XenoPort by not later than the earlier to occur of (i) [ * ] prior to the event or (ii) Patheon’s knowledge of such the event, if Adolor, or its Product Suppliers, as applicable, intend Patheon intends to change the nature or use of any of the specific areas or a portion of a facility the areas of the Facility or any module where Patheon manufactures, processes or stores Materials or Products to include the use of any of the Potential Contaminants. The Existing Product Suppliers have agreed to Patheon will not make such these changes if the change could reasonably be expected to [ * ] result in a material adverse effect on the Patheon’s ability to fully perform the its obligations under this Agreement and Adolor Patheon has not demonstrated to GSK’s reasonable satisfaction [ * ] that such the Potential Contaminants shall will be completely segregated from the Materials or Products at all timestimes and will not locate the same in the same building on the Facility.
Appears in 1 contract
Sources: Master Manufacturing and Supply Agreement (Xenoport Inc)