Certificates of Analysis and Manufacturing Compliance. 5.1 Certificates of Analysis DPT shall test each lot of Product purchased pursuant to this Agreement before delivery to COMPANY. Each Certificate of Analysis shall set forth the items tested, specifications and test results for each lot delivered. DPT shall send one (1) Certificate of Analysis, one (1) Certificate of Compliance, and a complete executed batch record including full analytical data set to COMPANY at the time of the release of Product. Extraordinary reporting or documentation, outside this Agreement, may be subject to an additional charge by DPT and will not be incurred without the prior written authorization of the COMPANY.
Appears in 1 contract
Samples: Manufacturing Agreement (Anacor Pharmaceuticals, Inc.)
Certificates of Analysis and Manufacturing Compliance. 5.1 Certificates of Analysis DPT shall test each lot of Product purchased pursuant to this Agreement before delivery to COMPANY. Each Certificate of Analysis shall set forth the items tested, specifications and test results for each lot delivered. DPT shall send one (1) Certificate of Analysis, one (1) Certificate of Compliance, and a complete executed batch record including full analytical data set Analysis to COMPANY at the time of the release of Product. Extraordinary reporting or documentation, outside this Agreement, may be subject to an additional charge by DPT and will not be incurred without the prior written authorization of the COMPANYDPT.
Appears in 1 contract
Certificates of Analysis and Manufacturing Compliance. 5.1 Certificates of Analysis DPT shall test each lot of Product purchased pursuant to this Agreement before delivery to COMPANY. Each Certificate of Analysis shall set forth the items tested, specifications and test results for each lot delivered. DPT shall send one (1) Certificate of Analysis, one (1) Certificate of Compliance, and a complete executed batch record including full analytical data set Analysis to COMPANY at the time of the release of Product. DPT shall provide a signed Certificate of Compliance Confirming that the Products have been manufactured, tested and stored in compliance with cGMP criteria. Extraordinary reporting or documentation, outside this Agreement, may be subject to an additional charge by DPT and will not be incurred without the prior written authorization of the COMPANYDPT.
Appears in 1 contract
Samples: Agreement (Barrier Therapeutics Inc)
Certificates of Analysis and Manufacturing Compliance. 5.1 Certificates of Analysis DPT shall test each lot of Product purchased pursuant to this Agreement before delivery to COMPANYAUXILIUM. Each Certificate of Analysis shall set forth the items tested, specifications and test results for each lot delivered. DPT shall send one (1) Certificate of Analysis, one (1) Certificate of Compliance, and a complete executed batch record including full analytical data set Analysis to COMPANY AUXILIUM at the time of the release of Product. Extraordinary reporting or documentation, outside this Agreement, may be subject to an additional charge by DPT and will not be incurred without the prior written authorization of the COMPANYDPT.
Appears in 1 contract
Samples: Manufacturing Agreement (Auxilium Pharmaceuticals Inc)