Reporting Adverse Drug Reactions. Alexion and XOMA will develop and agree upon safety data exchange procedures governing the collection, investigation, reporting, and exchange of information concerning Adverse Drug Reactions, product quality and product complaints involving Adverse Drug Reactions, sufficient to permit each Party to comply with its legal obligations, including to the extent applicable, those obligations contained in ICH guidelines E2A, E2B and E2C and the FDC Act. The safety data exchange procedures will be promptly updated if required by changes in legal requirements or by agreement between the Parties. Alexion will be responsible for reporting all Adverse Drug Reactions to the appropriate Regulatory Authorities in the Territory in accordance with applicable laws and regulations.
Reporting Adverse Drug Reactions. (a) Array shall hold and maintain the global safety database with respect to the Products. Array shall be responsible for core safety management of the Product, as provided in a pharmacovigilance agreement executed by the Parties pursuant to section 4.11(b), within and outside the Ono Territory; and Ono shall cooperate with and assist Array, as requested and/or as provided in the pharmacovigilance agreement executed by the Parties, to enable Array to meet its regulatory reporting requirements with respect to the core safety management for the Product within and outside the Ono Territory. Ono shall be responsible for all other pharmacovigilance activities associated with the Product in the Ono Territory, including filing all reports required to be filed in order to maintain any IND for the Product filed by or under the authority of Ono as the sponsor, and/or any Marketing Approvals granted for the Product, in the Ono Territory (including reporting of adverse drug experiences, product quality complaints and safety data relating to the Product in the Ono Territory). Each Party shall promptly notify the other Party with respect to any material changes or material issues that may arise in connection with any IND for the Product filed by or under the authority of such Party as the sponsor, and/or any Marketing Approvals for the Product, in any country within such Party’s territory.
Reporting Adverse Drug Reactions. Within one hundred eighty (180) days following the Regulatory Approval of the Product in mainland China and in the Territory, Angionetics will provide a draft Safety Data Exchange Agreement (SDEA) which shall be negotiated by the Parties in good faith and the Parties will enter into such Safety Data Exchange Agreement that more specifically sets forth the obligations of each Party with respect to the exchange of safety information and will require the Parties to comply with a standard operating procedure set forth therein governing the collection, investigation, reporting and exchange of safety information with respect to the Products, including but not limited to adverse events, product quality, and product complaints, sufficient to permit each Party (and in the case of Angionetics, any of its licensees of the Products outside the Territory) to comply with their respective legal obligations, all in accordance with Applicable Law. The SDEA will be promptly updated if required by changes in Applicable Law. Each Party shall keep the other Party informed about any adverse events of which such Party becomes aware or is informed regarding the use of Product in or outside the Territory. As between the Parties, Licensee shall be responsible for reporting all adverse events/experiences to the appropriate Regulatory Authorities in the Territory, and Angionetics shall be responsible for reporting all adverse events/experiences to the appropriate Regulatory Authorities in countries outside the Territory, in accordance with the appropriate laws and regulations of the relevant countries and authorities. Licensee shall ensure that its Affiliates comply with such safety reporting obligations in mainland China and in the Territory.
Reporting Adverse Drug Reactions. Promptly following the Effective Date but in no event later than six (6) months thereafter, Galderma and ZARS will develop and agree upon safety data exchange procedures in a separate and detailed Safety Agreement. ZARS shall use commercially reasonable efforts to have any relevant Affiliates and other licensees become a party to such Safety Agreement. Such agreement will describe the coordination of collection, investigation, reporting, and exchange of information concerning adverse events relating to Products (as defined in the then current edition of ICH Guidelines and any other relevant regulations or regulatory guidelines or any other safety problem of any significance, hereafter “Adverse Events”), product quality and product complaints involving Adverse Events, sufficient to permit each party, its Affiliates, Sublicensees or licensees to comply with its legal obligations, including to the extent applicable, those obligations contained in ICH guidelines. The safety data exchange procedures will be promptly updated if required by changes in legal requirements or by agreement between the parties. In any event, each party shall inform the other party of any Adverse Event of which it becomes aware in a timely manner commensurate with the seriousness of the Adverse Event. Galderma will be responsible for reporting all Adverse Events to the appropriate regulatory authorities in the countries in the Galderma Territory in accordance with the appropriate laws and regulations of the relevant countries and authorities and ZARS or its other licensees will be responsible for reporting all Adverse Events to the appropriate regulatory authorities in the ZARS Territory. Galderma will ensure that its Affiliates and Sublicensees comply with all such reporting obligations, and ZARS will ensure that its Affiliates and other licensees comply with all such reporting obligations. In addition, Galderma shall be responsible for implementing and maintaining a global safety database for the Products. Each party will designate a safety liaison to be responsible for communicating with the other party regarding the reporting of Adverse Events. ZARS shall reimburse Galderma for reasonable and documented out-of-pocket costs incurred solely in connection with the performance of Galderma’s obligations under this Section 4.10 in respect of any Product promoted by ZARS pursuant to Section 5.3, and such reimbursement shall not include, for the avoidance of doubt, any costs or expenses re...
Reporting Adverse Drug Reactions. The parties will develop and agree upon safety data exchange procedures governing the collection, investigation, reporting, and exchange of information concerning Adverse Drug Reactions, product quality and product complaints involving Adverse Drug Reactions, sufficient to permit each party to comply with its legal obligations, including to the extent applicable, those obligations contained in ICH guidelines E2A, E2B and E2C and the FDC Act. The safety data exchange procedures will be promptly updated if required by changes in the Law or by agreement between the parties. The party so designated in the applicable Development Plan will be responsible for reporting all Adverse Drug Reactions to the appropriate Regulatory Authorities in the applicable Region(s) in accordance with applicable Laws.
Reporting Adverse Drug Reactions. (a) Each Party shall be responsible for all pharmacovigilance activities associated with Licensed Products in its respective Territory, including filing all reports required to be filed in order to maintain any IND for Licensed Products filed by or under the authority of such Party, and/or any Regulatory Approvals granted for Licensed Products, in its Territory (including reporting of adverse drug experiences, product quality complaints and safety data relating to Licensed Products in its Territory). Each Party shall promptly notify the other Party with respect to any material changes or material issues that may arise in connection with any IND for a Licensed Product filed by or under the authority of the first Party, and/or any Regulatory Approvals for a Licensed Product, in any country within its Territory. Each Party shall ensure that its Affiliates and licensees (and, in the case of ORIC, Sublicensees) comply with such reporting obligations. ORIC shall be responsible for core safety management of Licensed Products on a global basis; and Voronoi shall cooperate with and assist ORIC, as provided in any pharmacovigilance agreement executed by the Parties pursuant to Section 4.12(b) below, to enable ORIC to meet its regulatory reporting requirements with respect to the core safety management for Licensed Products on a global basis.
Reporting Adverse Drug Reactions. (a) Licensor shall be responsible for maintaining the global safety database (“Global Safety Database”).
Reporting Adverse Drug Reactions. Alexion and XOMA will develop and agree upon safety data exchange procedures governing the collection, investigation, reporting, and exchange of information concerning Adverse Drug Reactions, product quality and product complaints involving Adverse Drug Reactions, sufficient to permit each Party to comply with its legal obligations, including to the extent applicable, those obligations contained in ICH guidelines
Reporting Adverse Drug Reactions. Takeda will be responsible for reporting all Adverse Drug Reactions to the appropriate Regulatory Authorities in the applicable country(ies) or region(s) in accordance with applicable Laws.
Reporting Adverse Drug Reactions. During the Transition Period, Sepracor shall, in accordance with Section 5.14, be responsible for filing all reports required to be filed in order to maintain any IND, MAA and/or any Marketing Approvals filed or granted for the Product in the GSK Territory, including reporting of adverse drug experiences. CONFIDENTIAL
