Manufactured Products. Each Party represents and warrants that all Products used in clinical trials and/or for commercial use that are Manufactured or procured by such Party shall: (a) meet the applicable specifications; (b) be Manufactured in accordance with cGMPs; and (c) be Manufactured in accordance with all applicable laws and regulations and Regulatory Authority requirements then in effect.
Appears in 3 contracts
Samples: License and Collaboration Agreement (Portola Pharmaceuticals Inc), License and Collaboration Agreement (Portola Pharmaceuticals Inc), License and Collaboration Agreement (Portola Pharmaceuticals Inc)
Manufactured Products. Each Party represents and warrants that all Compounds and Collaboration Products used in clinical trials and/or for commercial use that are Manufactured or procured and supplied by such Party for clinical trial and/or commercial use under this Agreement shall: (a) meet the applicable specifications; (b) be Manufactured in accordance with cGMPscurrent Good Manufacturing Practices; and (c) be Manufactured in accordance with all applicable laws and regulations and Regulatory Laws, including any Governmental Authority requirements then in effect.
Appears in 3 contracts
Samples: License and Collaboration Agreement (Cytokinetics Inc), License and Collaboration Agreement (Cytokinetics Inc), License and Collaboration Agreement (Cytokinetics Inc)
Manufactured Products. Each Party represents and warrants that all Products used in clinical trials and/or for commercial use that are Tirasemtiv and Product Manufactured or procured and supplied by such Party for clinical trial and/or commercial use under this Agreement shall: (a) meet the applicable specifications; (b) be Manufactured in accordance with cGMPscurrent Good Manufacturing Practices; and (c) be Manufactured in accordance with all applicable laws and regulations and Regulatory Laws, including any Governmental Authority requirements then in effect.
Appears in 1 contract
Samples: License and Collaboration Agreement (Cytokinetics Inc)