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 reports according to Applicable Laws and national and international guidelines (e.g., ICH, cGCP, cGLP, and cGMP).
Appears in 3 contracts
Samples: Collaboration and License Agreement (Exelixis, Inc.), Collaboration and License Agreement (Exelixis, Inc.), Collaboration and License Agreement (Exelixis, 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 clinical trials in formal written study reports according to Applicable applicable Laws and national and international guidelines (e.g., ICH, cGCPGCP, cGLPGLP, and cGMPGMP). Each Party shall have the right to review and copy such records maintained by the other Party at reasonable times and to obtain access to the original [*].
Appears in 3 contracts
Samples: License and Collaboration Agreement (Cytokinetics Inc), License and Collaboration Agreement (Cytokinetics Inc), 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 accurately and properly completely 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 reports according to Applicable Laws and national and international guidelines (e.g., ICH, cGCP, cGLP, and cGMP).
Appears in 2 contracts
Samples: License and Collaboration Agreement (Theravance Biopharma, Inc.), License and Collaboration Agreement (Theravance Biopharma, Inc.)
Development Records. Each Party shall maintain complete, current 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 and/or Studies in formal written study reports according to Applicable Laws and national and international guidelines (e.g., ICH, cGCPGCP, cGLPGLP, and cGMPGMP).
Appears in 2 contracts
Samples: Collaboration and License Agreement (Ovid Therapeutics Inc.), Collaboration and License Agreement (Ovid 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 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 reports according to Applicable Laws and national and international guidelines (e.g., ICH, cGCP, cGLP, and cGMP).. 4.11
Appears in 1 contract
Samples: Collaboration and License Agreement
Development Records. Each Party shall maintain complete, current and accurate records of all Development activities conducted by it or on behalf of such Party hereunder, and all data and other information Know How 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 reports according to Applicable Laws and national and international guidelines (e.g., ICH, cGCPGCP, cGLPGLP, and cGMP).
Appears in 1 contract
Development Records. Each Party shall maintain complete, current 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 reports according to Applicable Laws and national and international guidelines (e.g., ICH, cGCPGCP, cGLPGLP, and cGMPGMP).
Appears in 1 contract
Samples: Collaboration and License Agreement (Rigel Pharmaceuticals Inc)
Development Records. Each Party shall maintain complete, current current, and accurate records of all Development activities conducted by it hereunderunder this Agreement, 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 clinical trials in formal written study reports according to Applicable Laws and national and international guidelines (e.g., ICH, cGCP, cGLP, and cGMP).
Appears in 1 contract
Development Records. Each Party shall maintain reasonably complete, current and accurate records of all Development activities conducted by it hereunder, and all data and other information resulting from such activitiesactivities consistent with its usual practices. 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 reports according to Applicable Laws and national and international guidelines (e.g., ICH, cGCPGCP, cGLPGLP, and cGMPGMP).
Appears in 1 contract
Samples: License and Collaboration Agreement (Five Prime Therapeutics Inc)