Development Records. Each Party shall maintain complete, current and accurate records of all Development activities conducted by it hereunder, and all data and other Information resulting from such activities. Such records shall fully and properly reflect all work done and results achieved in the performance of the Development activities in good scientific manner appropriate for regulatory and patent purposes. Each Party shall document all non-clinical studies and clinical trials in formal written study records according to applicable Laws, including applicable national and international guidelines such as ICH, GCP and GLP. Each Party shall have the right to review and copy such records maintained by the other Party at reasonable times, and upon reasonable notice, to obtain access to the original records to the extent such Party has a license to use the Information contained in such records.
Appears in 3 contracts
Samples: License Agreement (Spectrum Pharmaceuticals Inc), License, Development and Commercialization Agreement (Allos Therapeutics Inc), License, Development and Commercialization Agreement (Allos Therapeutics Inc)
Development Records. Each Party shall maintain complete, current and accurate records of all Development activities conducted by it hereunder, and all data and other Information information resulting from such activities. Such records shall fully and properly reflect all work done and results achieved in the performance of the Development activities in good scientific manner appropriate for regulatory and patent purposes[ * ]. Each Party shall document all non-clinical studies and clinical trials in formal written study records reports according to applicable Laws, including applicable Laws and national and international guidelines such as (e.g., ICH, GCP GCP, GLP, and GLPGMP). Each Party shall have the right to review and copy such records maintained by the other Party at reasonable times, times and upon reasonable notice, to obtain access to the original records to the extent such Party has a license to use the Information contained in such records[ * ].
Appears in 1 contract
Samples: License and Collaboration Agreement (Cytokinetics Inc)
Development Records. Each Party shall maintain complete, current and accurate records of all Development activities conducted by it hereunder, and all data and other Information resulting from such activities. Such records shall fully and properly reflect all work done and results achieved in the performance of the Development activities in good scientific manner appropriate for regulatory and patent purposes. Each Party shall document all non-clinical studies and clinical trials in formal written study records according to applicable Laws, including applicable national and international guidelines such as ICH, GCP and GLP. Each Party shall have the right to review and copy such records maintained by the other Party at reasonable times, times and upon reasonable notice, to obtain access to the original records to the extent such Party has a license to use the Information contained in such recordsnecessary or useful for regulatory and patent purposes.
Appears in 1 contract
Samples: License, Development and Commercialization Agreement (Impax Laboratories Inc)