Non-Conforming Drug Product. Within fifteen (15) calendar days from the date of Production of any Batch pursuant to the Project Plan, XXXXXX shall promptly forward to CLIENT, or CLIENT’s designee, samples of such Batch. Within thirty (30) calendar days after receipt by CLIENT of the samples or fifteen (15) calendar days after receipt by CLIENT of the Released Executed Batch Record, whichever is later, CLIENT shall determine whether Drug Product conforms to CLIENT’s Drug Product Specifications, Master Batch Record, ALTHEA’s current SOPs, and the Project Plan (collectively the “Product Requirements”).
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Samples: www.sec.gov, Supply Agreement (Auxilium Pharmaceuticals Inc)
Non-Conforming Drug Product. Within fifteen (15) calendar days from the date of Production of any Batch pursuant to the Project Plan, XXXXXX shall promptly forward to CLIENT, or CLIENT’s designee, samples of such Batch. Within thirty (30) calendar days after receipt by CLIENT of the samples or fifteen (15) calendar days after receipt by CLIENT of the Released Executed Batch Record, whichever is later, CLIENT shall determine whether Drug Product conforms to CLIENTALTHEA’s Drug Product Specifications, Master Batch Record, ALTHEA’s current SOPs, and the Project Plan (collectively the “Product Requirements”).
Appears in 1 contract
Samples: Agreement
Non-Conforming Drug Product. Within fifteen (15) calendar days from the date of Production of any Batch pursuant to the Project Plan, XXXXXX AXXXXX shall promptly forward to CLIENT, or CLIENT’s designee, samples of such Batch. Within thirty sixty (3060) calendar days after receipt by CLIENT of the samples or fifteen (15) calendar days after receipt by CLIENT of the Batch and the Released Executed Batch Record, whichever is laterRecord for the Batch, CLIENT shall determine whether Drug Product conforms to CLIENT’s the Drug Product Specifications, the Master Batch Record, ALTHEA’s current SOPs, and the Project Plan (collectively the “Product Requirements”).
Appears in 1 contract
Samples: Development and Clinical Supply Agreement (Omeros Corp)
Non-Conforming Drug Product. Within fifteen (15) calendar days from the date of Production of any Batch pursuant to the Project Plan, XXXXXX shall promptly forward to CLIENT, or CLIENT’s designee, samples of such Batch. Within thirty sixty (3060) calendar days after receipt by CLIENT of the samples or fifteen (15) calendar days after receipt by CLIENT of the Batch and the Released Executed Batch Record, whichever is laterRecord for the Batch, CLIENT shall determine whether Drug Product conforms to CLIENT’s the Drug Product Specifications, the Master Batch Record, ALTHEA’s current SOPs, and the Project Plan (collectively the “Product Requirements”).
Appears in 1 contract
Samples: Development and Clinical Supply Agreement (Omeros Corp)
Non-Conforming Drug Product. Within fifteen (15) calendar days from the date of Production of any Batch pursuant to the Project Plan, XXXXXX AXXXXX shall promptly forward to CLIENT, or CLIENT’s designee, samples of such Batch. Within thirty (30) calendar days after receipt by CLIENT of the samples or fifteen (15) calendar days after receipt by CLIENT of the Released Executed Batch Record, whichever is later, CLIENT shall determine whether Drug Product conforms to CLIENTALTHEA’s Drug Product Specifications, Master Batch Record, ALTHEA’s current SOPs, and the Project Plan (collectively the “Product Requirements”).
Appears in 1 contract
Samples: Agreement (Bio-Path Holdings Inc)