Adverse Experience Reporting. 12.8 The responsibilities of the Parties for reporting of adverse drug experiences related to the Products to regulatory authorities in the Territory shall be performed in accordance with applicable laws and regulations. The responsibilities of the Parties for safety related or Product related inquiries shall be performed in accordance with applicable laws and regulations.
Appears in 1 contract
Samples: Licence Agreement
Adverse Experience Reporting. 12.8 6.1 The responsibilities of the Parties for reporting of adverse drug experiences related to the Products Licensed Product to regulatory authorities in the Territory Target Countries shall be performed in accordance with applicable local laws and regulations. The responsibilities of the Parties for safety related or Licensed Product related inquiries shall be performed in accordance with applicable local laws and regulations.
Appears in 1 contract
Samples: License Agreement
Adverse Experience Reporting. 12.8 6.1 The responsibilities of the Parties for reporting of adverse drug experiences related to the Products to regulatory authorities in the Territory shall be performed in accordance with applicable local laws and regulations. The responsibilities of the Parties for safety related or Product related inquiries shall be performed in accordance with applicable local laws and regulations.
Appears in 1 contract
Samples: Licence Agreement
Adverse Experience Reporting. 12.8 7.1 The responsibilities of the Parties for reporting of adverse drug experiences related to the Products to regulatory authorities in the Territory shall be performed in accordance with applicable local laws and regulations. The responsibilities of the Parties for safety related or Product related inquiries shall be performed in accordance with applicable local laws and regulations.
Appears in 1 contract
Samples: Licence Agreement