Release Certificate. LGLS shall provide to GS with each delivery of Final Product or API a Release Certificate, a Certificate of Analysis, and a Certificate of Compliance signed by a responsible person duly authorized by LGLS or GLAXO to certify the quality of Final Product or API delivered, each in a form reasonably acceptable to GS. The Release Certificate shall, inter alia, state that the results of the agreed upon testing procedures are in compliance with the Final Product or API Specifications as well as any additional applicable requirements of Regulatory Authorities. Without limiting the foregoing, unless expressly agreed by the Parties all Final Products or API supplied hereunder shall meet all release criteria established by the FDA or EMEA with respect to such Final Product or API.
Appears in 2 contracts
Samples: License & Option Agreement (Oscient Pharmaceuticals Corp), License & Option Agreement (Oscient Pharmaceuticals Corp)
Release Certificate. LGLS shall provide to GS with each delivery of Final Product or API a Release Certificate, a Certificate of Analysis, Analysis and a Certificate of Compliance signed by a responsible person duly authorized by LGLS or GLAXO to certify the quality of Final Product or the API delivered, each in a form reasonably acceptable to GS. The Release Certificate shall, inter alia, state that the results of the agreed upon testing procedures are in compliance with the Final Product or API Specifications as well as any additional applicable requirements of Regulatory Authorities. Without limiting the foregoing, unless expressly agreed by the Parties all Final Products or API supplied hereunder shall meet all release criteria established by the FDA or EMEA with respect to such Final Product or APIProduct.
Appears in 2 contracts
Samples: License and Option Agreement (Cornerstone Therapeutics Inc), License and Option Agreement (Oscient Pharmaceuticals Corp)
Release Certificate. LGLS shall provide to GS with each delivery of Final Product or API a Release Certificate, a Certificate of Analysis, Analysis and a Certificate of Compliance signed by a responsible person duly authorized by LGLS or GLAXO to certify the quality of Final Product or the API delivered, each in a form reasonably acceptable to GS. The Release Certificate shall, inter alia, state that the results of the agreed upon testing procedures are in compliance with the Final Product or API Specifications as well as any additional applicable requirements of Regulatory Authorities. Without limiting the foregoing, unless expressly agreed by the Parties all Final Products or API supplied hereunder shall meet all release criteria established by the FDA or EMEA with respect to such Final Product or APIProduct. * Confidential information has been omitted and filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request.
Appears in 1 contract
Samples: License and Option Agreement (Oscient Pharmaceuticals Corp)