Example ContractsClausesAdverse Events Reporting
Adverse Events Reporting
Adverse Events Reporting contract clause examples

Adverse Events Reporting. [[Organization A:Organization]] shall be responsible for reporting all safety related events for the Licensed Product to appropriate Regulatory Authorities according to the Applicable Law and provide all necessary safety reporting information to ensure [[Agenus:Organization]] meets all applicable regulatory reporting obligations. [[Agenus:Organization]] shall be responsible for reporting all safety related events, including annual reporting obligations, for the [[Agenus:Organization]] Antibody to the appropriate Regulatory Authorities according to Applicable Law. [[Organization A:Organization]] and [[Agenus:Organization]] shall keep each other reasonably informed of any adverse reactions, or other material safety findings related to the Licensed Product or [[Agenus:Organization]] Antibody. The Parties shall coordinate adverse event reporting in accordance with a Safety Data Exchange Agreement to be entered into by the Parties after the Effective Date, as it may be amended by the Parties from time to time (“SDEA”).

Adverse Events Reporting. If applicable, at least [ * ] prior to the [ * ] Development [ * ] Development or as otherwise may be required to satisfy regulatory requirements, the Parties shall enter into a pharmacovigilance agreement setting forth the worldwide pharmacovigilance procedures for the Parties with respect to the studies for the Collaboration Products (the “Pharmacovigilance Agreement”). The Pharmacovigilance Agreement shall be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under applicable Laws. The Parties shall discuss and agree on the update of the Pharmacovigilance Agreement to include obligations related to Commercialization of the Collaboration Products prior to Regulatory Approval in any given territory.

Adverse Events Reporting. Betta will be responsible for reporting all safety related events for the Licensed Antibodies and Licensed Products to appropriate Regulatory Authorities in the Territory according to the Applicable Law and provide all necessary safety reporting information to ensure [[Agenus:Organization]] meets all applicable regulatory reporting obligations. [[Agenus:Organization]] will be responsible for reporting all safety related events, including annual reporting obligations, for the Licensed Antibodies and Licensed Product to the appropriate Regulatory Authorities outside the Territory according to Applicable Law. Betta and [[Agenus:Organization]] will keep each other informed of any serious adverse reactions, or other significant, unusual or unexpected safety findings related to either Licensed Antibody in English ​; provided that [[Agenus:Organization]] will only be required to inform Betta of any serious adverse reactions, or other significant, unusual or unexpected safety findings related to a Licensed Antibody in a monotherapy setting or in combination with one another but excluding combinations of either or both Licensed Antibodies with any Other Component. In addition, Betta will provide summary safety reports in English to [[Agenus:Organization]] ​ or more frequently as required to meet regulatory requests. The Parties will coordinate adverse event reporting in accordance with a Safety Data Exchange Agreement (the “SDEA”) to be entered into by the Parties ​ after the Effective Date, which will be consistent with this Section 4.6 and in substantially the form attached as [Schedule 4.6]. The Parties may, if agreed under such SDEA, coordinate such activities through the JSC or the JSC may designate an appropriate person(s) to oversee pharmacovigilance matters.

Adverse Events Reporting. Promptly following the Effective Date, but in no event later than ​ thereafter, Alexion and Eidos shall develop and agree in a written agreement to worldwide safety and pharmacovigilance procedures for the Parties with respect to Licensed Products, such as safety data sharing and exchange, adverse events reporting and prescription events monitoring (the “Pharmacovigilance Agreement”). Such Pharmacovigilance Agreement shall describe the obligations of both Parties with respect to the coordination of collection, investigation, reporting and exchange of information between the Parties concerning adverse events or any other safety issue of any significance and product quality and product complaints involving adverse events, in each case with respect to Licensed Products and sufficient to permit each Party and its Affiliates, Third Party Licensees and Sublicensees to comply with its legal obligations with respect thereto. The Pharmacovigilance Agreement shall be promptly updated if required by changes in Applicable Law. Each Party hereby agrees to comply with its respective obligations under the Pharmacovigilance Agreement and to cause its Affiliates, Third Party Licensees and Sublicensees to comply with such obligations. Without limiting the foregoing, Eidos will be responsible for maintaining a global adverse event database for all Clinical Trials conducted in the Territory and the ROW Territory, ​.

Following the Effective Date, but in no event less than ninety (90) days prior to the initiation of a Phase II Clinical Trial by either Newsoara or vTv, Newsoara and vTv will develop and agree to worldwide safety and pharmacovigilance procedures for the Parties with respect to the Products, such as safety data sharing and exchange, Adverse Events reporting and prescription events monitoring in a written agreement (the “Safety Agreement”). Such agreement will describe the coordination of collection, investigation, reporting, and exchange of information concerning Adverse Events or any other safety problem of any significance, and product quality and product complaints involving Adverse Events, sufficient to permit each Party, its Affiliates, licensees or sublicensees to comply with its legal obligations. The Safety Agreement will be promptly updated if required by changes in legal requirements. Each Party hereby agrees to comply with its respective obligations under the Safety Agreement and to cause its Affiliates, licensees and sublicensees to comply with such obligations. To the extent there is any disagreement between this [Section 5.2] or any related definitions and the Safety Agreement, the Safety Agreement shall control with respect to safety matters and this Agreement shall control with respect to all other matters.

Following the Effective Date, but in no event later than ninety (90) days prior to the initiation of Phase II MRCT, Huadong and vTv shall develop and agree to the worldwide safety and pharmacovigilance procedures for the Parties with respect to the Products, such as safety data sharing and exchange, Adverse Events reporting and prescription events monitoring in a written agreement (the “Safety Agreement”). Such agreement shall describe the coordination of collection, investigation, reporting, and exchange of information concerning Adverse Events or any other safety problem of any significance, and product quality and product complaints involving Adverse Events, sufficient to permit each Party, its Affiliates, licensees or sublicensees to comply with its legal obligations. The Safety Agreement shall be promptly updated if required by changes in legal requirements. Each Party hereby agrees to comply with its respective obligations under the Safety Agreement and to cause its Affiliates, licensees and sublicensees to comply with such obligations. To the extent there is any disagreement between this [Section 5.3] or any related definitions and the Safety Agreement, the Safety Agreement shall control with respect to safety matters and this Agreement shall control with respect to all other matters.

Adverse Events Reporting; Quality. At least ​ prior to the expected initiation of the first Clinical Trial under this Agreement, the Parties shall enter into a pharmacovigilance and adverse event reporting agreement setting forth the worldwide pharmacovigilance procedures for the Parties with respect to the Product, such as safety data sharing, adverse events reporting and prescription events monitoring (the “Pharmacovigilance Agreement”). Such procedures shall be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under Applicable Laws. [[Cytokinetics:Organization]] shall establish and maintain the global safety database for the Product and conduct overall signal detection and benefit risk evaluation of the Product. Each Party shall hold the primary responsibility for reporting quality complaints, adverse events and safety data related to the Product in its territory to such database and to the applicable Regulatory Authorities in its territory, as well as responding to safety issues and to all requests of Regulatory Authorities in its territory related to the Product, in each case at its own cost and to the extent required by the Applicable Laws. [[Cytokinetics:Organization]] agrees to support Ji Xing on safety issues or safety request related to the Product when output from global safety database is required. At least ​ prior to the expected initiation of the first Clinical Trial under this Agreement, the Parties shall enter into a clinical quality agreement for the Territory (the “Clinical Quality Agreement”). Each Party agrees to comply with its respective obligations under the Pharmacovigilance Agreement and Clinical Quality Agreement and to cause its Affiliates, licensees and sublicensees to comply with such obligations.

Adverse Events Reporting; Quality. At least ​ prior to the expected initiation of the first Clinical Trial under this Agreement, the Parties shall enter into a pharmacovigilance and adverse event reporting agreement setting forth the worldwide pharmacovigilance procedures for the Parties with respect to the Product, such as safety data sharing, adverse events reporting and prescription events monitoring (the “Pharmacovigilance Agreement”). Such procedures shall be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under Applicable Laws. [[Cytokinetics:Organization]] shall establish and maintain the global safety database for the Product and conduct overall signal detection and benefit risk evaluation of the Product. Each Party shall hold the primary responsibility for reporting quality complaints, adverse events and safety data related to the Product in its territory to such database and to the applicable Regulatory Authorities in its territory, as well as responding to safety issues and to all requests of Regulatory Authorities in its territory related to the Product, in each case at its own cost and to the extent required by the Applicable Laws. [[Cytokinetics:Organization]] agrees to support Ji Xing on safety issues or safety request related to the Product when output from global safety database is required. At least ​ prior to the expected initiation of the first Clinical Trial under this Agreement, the Parties shall enter into a clinical quality agreement for the Territory (the “Clinical Quality Agreement”). Each Party agrees to comply with its respective obligations under the Pharmacovigilance Agreement and Clinical Quality Agreement and to cause its Affiliates, licensees and sublicensees to comply with such obligations.

Adverse Events. Licensee will be solely responsible for the collection, review, assessment, tracking and filing of information related to adverse events associated with Product in the Field in the Territory, in accordance with all Applicable Law and will, upon request of MSD, provide MSD with copies of adverse event reports and information related thereto.

Adverse Events. Each Party (the “Notifying Party”) shall notify the other Party of all information coming to the Notifying Party’s attention, regardless of the origin of Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets ​ and an asterisk*, have been separately filed with the Securities and Exchange Commission.

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