Global Safety Database; Pharmacovigilance Agreement. At a time to be mutually agreed by the Parties, the Lead US Party shall establish, hold and maintain a single electronic system for the collection and storage of all safety information for the Shared Products in the Territory (the “Global Safety Database”). Such database shall comply in all material respects with all Laws reasonably applicable to pharmacovigilance anywhere where the Shared Products are being or have been Developed or Commercialized. Unless the Parties otherwise agree in the Pharmacovigilance Agreement, the Lead US Party shall initially be responsible for the Global Safety Database for the Shared Products and the other Party shall assume control on a Shared Product-by-Shared Product basis following the transfer, if any, of lead responsibility for Regulatory Interactions in the US Territory for such Shared Product to the other Party. The Party not maintaining the Global Safety Database may hold and maintain a parallel safety database for the Shared Products as needed or required according to applicable Laws. The Parties will use Commercially Reasonable Efforts to negotiate a pharmacovigilance agreement (the “Pharmacovigilance Agreement”) to govern cooperation among the Parties that will enable each of them to comply with its respective obligations under applicable Laws and to satisfy its duty of care with respect to the Shared Products, including with regard to ownership of the Global Safety Database, adverse event data collection, analysis and reporting. The Pharmacovigilance Agreement will be entered among the Parties no later than [***] days following the Effective Date.
Global Safety Database; Pharmacovigilance Agreement. Incyte shall establish, hold and maintain the global safety database for Program 1 Product (the “Global Safety Database”) into which it shall enter information on all adverse events concerning the Program 1 Product occurring anywhere in the world and reported to either of the Parties in accordance with a pharmacovigilance agreement for the Program 1 Product to be negotiated and entered into by the Parties at least [**] prior to FPFV for the first Clinical Trial (each, a “Pharmacovigilance Agreement”). Pursuant to the terms of the Pharmacovigilance Agreement, such database shall comply in all material respects with all Laws reasonably applicable to pharmacovigilance anywhere the Program 1 Product is being or has been Developed or Commercialized. The Pharmacovigilance Agreement shall, among other things, govern cooperation between the Parties that will enable each of them to comply with its respective obligations under applicable Laws with regard to adverse event data collection, analysis and reporting to Regulatory Authorities and to enable each Party to satisfy its duty of care, and to govern the Global Safety Database. Pursuant to the terms of the Pharmacovigilance Agreement, Merus shall have access and rights to use the Global Safety Database, and each Party shall provide information on all adverse events concerning Program 1 Product for the Global Safety Database.
Global Safety Database; Pharmacovigilance Agreement. At a time to be mutually agreed by the Parties, the Parties shall establish, hold and maintain a single electronic system for the collection and storage of all safety information for each Licensed Compound and/or Licensed Product (the “Global Safety Database”). Such database shall comply in all material respects with all Laws reasonably applicable to pharmacovigilance anywhere where the Licensed Compounds and Licensed Products are being or have been Developed or Commercialized. Unless the Parties otherwise agree in the Pharmacovigilance Agreement, Agios shall initially be responsible for the Global Safety Database, and on a Program-by-Program basis Celgene shall assume control following the transfer of all INDs for such Program to Celgene (excluding Buy-In Programs for which Agios is the Commercializing Party); provided that the JDC shall determine by Mutual Consent which Party shall be responsible for the Global Safety Database for Split Programs, with the other Party providing support to such first Party. The Party not maintaining the Global Safety Database may hold and maintain a parallel safety database for any Licensed Compound or Licensed Product as needed or required according to applicable Laws. The Parties will use Commercially Reasonable Efforts to negotiate a pharmacovigilance agreement (the “Pharmacovigilance Agreement”) to govern cooperation between the Parties that will enable each of them to comply with its respective obligations under applicable Laws and to satisfy its duty of care with respect to Licensed Compounds and Licensed Products, including with regard to ownership of the Global Safety Database, adverse event data collection, analysis and reporting. The Pharmacovigilance Agreement will be entered by the Parties either prior to the FPD for the first Clinical Trial related to a Discovery Program or Licensed Program or, at Celgene’s election, upon transfer of all INDs for such Program to Celgene.
Global Safety Database; Pharmacovigilance Agreement. At a time to be mutually agreed by the Parties, Celgene shall establish, hold and maintain a single electronic system for the collection and storage of all safety information for the Shared Products in the Territory (the “Global Safety Database”). Such database shall comply in all material respects with all Laws reasonably applicable to pharmacovigilance anywhere where the Shared Products are being or have been Developed or Commercialized. Unless the Parties otherwise agree in the Pharmacovigilance Agreement, Celgene shall be responsible for the Global Safety Database for the Shared Products; provided, that Vividion may hold and maintain a parallel safety database for the Shared Products as needed or required according to applicable Laws. The Parties will use Commercially Reasonable Efforts to negotiate a pharmacovigilance agreement (the “Pharmacovigilance Agreement”) to govern cooperation among the Parties that will enable each of them to comply with its respective obligations under applicable Laws and to satisfy its duty of care with respect to the Shared Products, including with regard to ownership of the Global Safety Database, adverse event data collection, analysis and reporting. The Pharmacovigilance Agreement will be entered among the Parties no later than [***] days following the Effective Date.
Global Safety Database; Pharmacovigilance Agreement. Contemporaneous with Novartis’ assumption of responsibility for study 352, Novartis shall establish, hold and maintain the global safety databases for each Licensed Product (the “Global Safety Database”) into which it shall enter information on all adverse events concerning the Licensed Product occurring anywhere in the world and reported to either of the Parties in accordance with a pharmacovigilance agreement for each Licensed Product in substantially the same form as the draft agreements attached in Exhibit I (each, “Pharmacovigilance Agreement”), which the Parties shall execute on the Effective Date. Pursuant to the terms of the Pharmacovigilance Agreement, such database shall comply in all material respects with all Laws reasonably applicable to pharmacovigilance anywhere where the Licensed Products are being or have been Developed or Commercialized. The Pharmacovigilance Agreement shall, among other things, govern cooperation between the Parties that will enable each of them to comply with its respective obligations under applicable Laws with regard to adverse event data collection, analysis and reporting and to enable each Party to satisfy its duty of care, and to govern the Global Safety Database.
Global Safety Database; Pharmacovigilance Agreement. Subject to the Regulatory Transition, Incyte shall establish, hold and maintain the global safety database for each Licensed Compound and Licensed Product (the “Global Safety Database”) into which it shall enter information on all adverse events concerning such Licensed Compound and Licensed Product occurring anywhere in the world and reported to either of the Parties in accordance with a pharmacovigilance agreement for each such Licensed Compound and Licensed Product to be negotiated and entered into by the Parties within [ * ] after the Execution Date (each, a [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. “Pharmacovigilance Agreement”). Pursuant to the terms of the Pharmacovigilance Agreement, such database shall comply in all material respects with all Laws reasonably applicable to pharmacovigilance anywhere where such Licensed Compounds and Licensed Products are being or have been Developed or Commercialized. The Pharmacovigilance Agreement shall, among other things, govern cooperation between the Parties that will enable each of them to comply with its respective obligations under applicable Laws with regard to adverse event data collection, analysis and reporting and to enable each Party to satisfy its duty of care, and to govern the Global Safety Database. Pursuant to the terms of the Pharmacovigilance Agreement, Calithera shall provide information on all adverse events concerning Licensed Compounds and Licensed Products for Incyte’s Global Safety Database, and all clinical data generated from a Clinical Trial conducted by it, on or prior to the Regulatory Transition and, at any time during the Term, for Incyte’s Global Safety Database or Incyte’s data management database, as appropriate. Calithera will transmit to Incyte all serious life threatening or death events in [ * ] and all other serious events in [ * ]. Incyte will be responsible for reporting adverse events to the FDA and any other Regulatory Authorities as required.
Global Safety Database; Pharmacovigilance Agreement. The Parties will use Commercially Reasonable Efforts to negotiate a pharmacovigilance agreement (the “Pharmacovigilance Agreement”) to govern cooperation among the Parties together with Celgene USA and Agios USA that will enable each of them to comply with its respective obligations under applicable Laws and to satisfy its duty of care with respect to the Licensed Products, including with regard to ownership of the Global Safety Database, adverse event data collection, analysis and reporting. The Pharmacovigilance Agreement will be entered among the Parties together with Celgene USA and Agios USA no later than the completion of the first Phase I Study of a Licensed Product.
Global Safety Database; Pharmacovigilance Agreement. At a time to be mutually agreed by the Parties and subject to the Pharmacovigilance Agreement, BeiGene shall establish, hold and maintain a single electronic system for the collection and storage of all safety information for the Products in the Territory (the “Global Safety Database”). Such database shall comply in all material respects with all Laws reasonably applicable to pharmacovigilance anywhere where the Products are being or have been Developed or Commercialized. BioAtla may hold and maintain a parallel safety database for the Products as needed or required by applicable Laws. The Parties will use Commercially Reasonable Efforts to negotiate a pharmacovigilance agreement (the “Pharmacovigilance Agreement”) to govern cooperation among the Parties that will enable each of them to comply with its respective obligations under applicable Laws and to satisfy its duty of care with respect to the Products, including with regard to ownership of the Global Safety Database, adverse event data collection, analysis and reporting and access to the Global Safety Database. The Pharmacovigilance Agreement will be entered among the Parties no later than ninety (90) days following the Effective Date.
Global Safety Database; Pharmacovigilance Agreement. Within [ ] ([ ]) [ ] of the Effective Date, the Parties shall negotiate, acting reasonably and in good faith, and execute a pharmacovigilance agreement for the Licensed Products with customary terms and conditions (the “Pharmacovigilance Agreement”). The Pharmacovigilance Agreement shall, among other things, govern cooperation between the Parties that will enable each of them to comply with its respective obligations under applicable Laws with regard to adverse event data collection, analysis, and reporting and to enable each Party to satisfy its duty of care. Eyenovia shall establish, hold, and maintain the global safety databases for each Licensed Product (and the Device itself) (the “Global Safety Database”) into which it shall enter information on all adverse events concerning such Licensed Products occurring anywhere in the world and reported to either of the Parties, in accordance with the Pharmacovigilance Agreement.
Global Safety Database; Pharmacovigilance Agreement. AzurRx shall be solely responsible for, and have the right with respect to, establishing (if applicable), holding and maintaining the global safety database(s) for each Product in the Field in the Territory. At the request of either Party, the Parties shall enter into a reasonable and customary written pharmacovigilance agreement (the “Pharmacovigilance Agreement”) governing each Party’s obligations with respect to reporting to the other Party and appropriate Regulatory Authorities Adverse Events, complaints, and other safety-related matters with respect to the applicable Product as required by law. The Parties shall cooperate across their respective fields regarding the reciprocal exchange of safety-related Regulatory Materials about the Product, and shall each assist the other Party with the Regulatory Activities for such Product inside or outside the Field, as applicable, in the Territory, and at the cost and expense of the Party responsible for such Regulatory Activities.
