Common use of Pharmacovigilance Clause in Contracts

Pharmacovigilance. 4.1 Licensee undertakes that it will maintain until the termination of this Agreement (or, as applicable, until the rights and obligations intended to survive termination of this Agreement have been fulfilled) pharmacovigilance and risk management systems, procedures and documentation needed to perform and comply with its regulatory obligations and its related obligations under this Agreement. 4.2 If Licensee becomes aware of any adverse reaction relating to the Licensed Products in connection with this Agreement, Licensee shall inform Licensor and AbbVie within 1 day of its becoming aware and cooperate with AbbVie in fulfilling AbbVie’s reporting responsibilities under applicable laws and regulations. 4.3 Licensee undertakes that it will ensure that it will comply with all applicable laws and regulations regarding the Licensed Products in the Territory including without limitation those laws and regulations relating to risk management, drug safety and pharmacovigilance. 4.4 Licensee will be responsible for fulfilling all pharmacovigilance activities as per the local regulations and requirements for the Licensed Products in the Territory and provide Licensor with a report containing information regarding all such activities. Such report shall be provided annually and otherwise on reasonable request by the Licensor.

Pharmacovigilance. 4.1 Licensee undertakes that it will maintain until the termination of this Agreement (or, as applicable, until the rights and obligations intended to survive termination of this ofthis Agreement have been fulfilled) pharmacovigilance and risk management systems, procedures and documentation needed to perform and comply with its regulatory obligations and its related obligations under this Agreement. 4.2 If Licensee becomes aware of any adverse reaction relating to the Licensed Products in connection with this Agreement, Licensee shall inform Licensor and AbbVie within 1 day of its becoming aware and cooperate with AbbVie in fulfilling AbbVie’s reporting 's repo1ting responsibilities under applicable laws and regulations. 4.3 Licensee undertakes that it will ensure that it will comply with all applicable laws and regulations regarding the Licensed Products in the Territory including without limitation those laws and regulations relating to risk management, drug safety and pharmacovigilance. 4.4 Licensee will be responsible for fulfilling all pharmacovigilance activities as per the local regulations and requirements for the Licensed Products in the Territory and provide Licensor with a report containing information regarding all such activities. Such report shall be provided annually and otherwise on reasonable request by the Licensor.