Scientific Records. Each Party shall maintain complete, current and accurate records of all Development work conducted by or on behalf of each Party and/or, to the extent practicable and permissible, its Related Party, and all Clinical Data, Data and other Know-How resulting from such work. Such records shall fully and properly reflect all work done and results achieved in the performance of the Development activities in a good scientific manner appropriate for regulatory and patent purposes. Subject to Section 7.1.3, Each Party shall, and shall use Commercially Reasonable Efforts to cause its Related Party to, document all Clinical Studies and other studies and research in formal written study reports in accordance with applicable guidelines (e.g., GCP, GLP, and GMP) and all other applicable Law. Subject to 7.1.3, each Party shall, and shall use Commercially Reasonable Efforts to cause its Related Party to make all such Clinical Data, records and reports continuously available, within a reasonable period following their creation, to the other Party for inspection and review (including, to the extent reasonably requested, copying) through appropriate electronic data room facilities. Subject to applicable Law (including, but not limited to, the data privacy act in each country), each Party shall also have the right to review original versions of such records maintained by other Party and its Affiliates (and, to the extent permissible, its Related Parties) no more often than [**], at reasonable times, upon written request to other Party.
Appears in 1 contract
Scientific Records. Each Subject to Section 7.1.3, each Party shall and shall use Commercially Reasonable Efforts to cause its Related Party to maintain complete, current and accurate records of all Development work conducted by or on behalf of each Party and/or, to the extent practicable and permissible, and/or its Related Party, and all Clinical Data, Data and other Know-How resulting from such work. Such records shall fully and properly reflect all work done and results achieved in the performance of the Development activities in a good scientific manner appropriate for regulatory and patent purposes. Subject to Section 7.1.3, Each Party shall, and shall use Commercially Reasonable Efforts to cause its Related Party to, document all Clinical Studies and other studies and research in formal written study reports in accordance with applicable guidelines (e.g., GCP, GLP, and GMP) and all other applicable Law. Subject to 7.1.3, each Party shall, and shall use Commercially Reasonable Efforts to cause its Related Party Party, to make all such Clinical Data, records and reports continuously available, within a reasonable period following their creation, to the other Party for inspection and review (including, to the extent reasonably requested, copying) through appropriate electronic data room facilities. Subject to applicable Law (including, but not limited to, the data privacy act in each country), each Party shall also have the right to review original versions of such records maintained by other Party and its Affiliates (and, to the extent permissible, its Related Parties) no more often than [**], at reasonable times, upon written request to other Party.
Appears in 1 contract