Drug Safety Information. ViroPharma shall have the sole right to create and maintain a master drug safety database which shall cross-reference any adverse event relating to a Licensed Product occurring anywhere in the Territory. ViroPharma shall be the sole owner of this master drug safety database.
Drug Safety Information. Recipient shall immediately provide Corautus with drug safety requests from all governmental and other regulatory authorities with respect to the Original Biological Materials. Proposed answers by Recipient affecting Original Biological Materials will be provided to Corautus before submission, and the Parties shall cooperate with respect to such answers.
Drug Safety Information. Both Parties shall comply fully with all applicable adverse event reporting recommendations and requirements in all countries where the Parties intend to carry out clinical trials and/or to market the Products and agree to exchange such information as may be necessary to achieve that end and to ensure that both Parties are completely informed regarding adverse events with Products. This includes single case reports, together with an appropriate medical evaluation, as well as aggregate data, such as PSURs required by authorities. Vitae shall provide BI with all information on the safety of 00x XXX-0 Inhibitors which is in Vitae’s possession as of the execution of this Agreement or thereafter.
Drug Safety Information. Both Parties shall comply fully with all applicable adverse event reporting recommendations and requirements in all countries where the Parties intend to market the Licensed Products and agree to exchange such information as may be necessary to achieve that end and to ensure that both Parties are completely informed regarding adverse events with respect to Licensed Products. This includes single case reports, together with an appropriate medical evaluation, as well as aggregate data, such as PSURs required by authorities. Both Parties will execute and implement a detailed pharmacovigilance agreement pertaining to Licensed Products in the Recepta Territory no later than [***] months before the earlier of the following events: (i) Recepta or Mersana is physically and/or legally able to distribute Licensed Products in the market, in a clinical trial or for whatever purpose, or (ii) Recepta or Mersana has a Regulatory Approval, a clinical trial authorization, or has regulatory reporting obligations for any other reason.
Drug Safety Information. Salix shall have the sole right to create and maintain a master drug safety database which shall cross-reference any Adverse Event relating to the Licensed Product occurring in the Territory. Salix shall be the sole owner of this master drug safety database. Lupin shall submit to Salix all data collected by it with respect to Adverse Events relating to the Licensed Product in accordance with such timelines as may be imposed by Applicable Law and otherwise promptly. Notwithstanding the foregoing, the Parties acknowledge and agree that Lupin is responsible for creating a similar database for Adverse Events outside the Territory and the Parties shall cooperate in providing data for both databases.
Drug Safety Information. The Parties will at least 3 (three) months prior to the issuance of the first Marketing Authorization for a Licensed Product in the Field in either the U.S. or the EU, execute a pharmacovigilance agreement detailing their respective obligations for recording, investigating, summarizing, notifying, reporting and reviewing all Adverse Drug Experiences in relation to Licensed Products in the Territory in accordance with applicable Laws. Each Party shall require that its Affiliates (i) adhere to all requirements of applicable Laws which relate to the reporting and investigation of Adverse Drug Experiences, and (ii) keep the JSC apprised on a regular basis of such matters arising therefrom. For clarity, prior to the Transfer Date, THERAVANCE shall be responsible for all reporting of Adverse Drug Experiences in relation to the Licensed Product in the Field in the U.S., and on the Transfer Date such responsibilities shall transfer to MYLAN. Except as set forth in the preceding sentence or as otherwise agreed by the Parties pursuant to the pharmacovigilance agreement, MYLAN shall be responsible for managing pharmacovigilance for Licensed Products in the Field in the Territory.
Drug Safety Information. Lian, as the owner of Regulatory Approvals for the Licensed Products in the Field throughout the Territory, shall be responsible for investigating Adverse Events and other required safety information associated with the use of the Licensed Product in the Field in the Territory and shall be responsible for the collection, review, assessment, tracking and filing of information related to Adverse Events in accordance with applicable Laws, provided that, if Tarsus is required by any Regulatory Authority to file in its name and own any Regulatory Approval for a Licensed Product in the Field in a Region in the Territory, then in such Region Tarsus shall be responsible for investigating Adverse Events and other required safety information associated with the use of the Licensed Product in the applicable Region and shall, at Lian’s expense, be responsible for the collection, review, assessment, tracking and filing of information related to Adverse Events in accordance with applicable Laws. Lian shall comply fully with all applicable Adverse Event reporting recommendations and requirements in all Regions in the Territory where Lian intends to Commercialize the Licensed Product. Each Party agrees to exchange with the other Party such information as may be necessary for compliance with applicable Adverse Event reporting requirements and to ensure that such Party is completely informed regarding Adverse Events with respect to the Licensed Product. This includes single case reports, together with an appropriate medical evaluation, as well as aggregate data, such as Periodic Safety Update Reports (PSURs) required by authorities. Within [***] days after the Effective Date, the Parties shall enter into a pharmacovigilance agreement that defines the Parties’ responsibilities and obligations with respect to the procedures and timeframes for compliance with applicable Law pertaining to safety reporting for the Licensed Product.
Drug Safety Information. Both Parties shall comply fully with all applicable adverse event reporting recommendations and requirements in all countries where the Parties intend to carry out clinical trials and/or to market the Products and agree to exchange such information as may be necessary to achieve that end and to ensure that both Parties are completely informed regarding adverse events with Products. This includes single case reports, together with an appropriate medical evaluation, as well as aggregate data, such as PSURs required by authorities. Vitae shall provide BI with all information on the safety of 00x XXX-0 Inhibitors which is in Vitae’s possession as of the execution of this Agreement or thereafter. ****CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. This includes all adverse event reports received in the past, published literature and previous actions taken by Vitae or by authorities due to safety issues. The Parties agree that the most effective and efficient method for exchanging safety information is electronically. If electronic transmission capability between the Parties is not possible or is interrupted, other methods for the exchange of safety information such as telefax or courier service will be used. Interruptions to electronic data transfer will be kept to a minimum. The transfer of safety information between the Parties will be made in an electronic format that complies with the ICH Guidance on Data Elements for Transmission of Individual Case Safety Reports. Transmission procedures specified by the ICH Electronic Standards for the Transfer of Regulatory Information (ICH M2) will be used at such time as these come into force as defined either in the Step 5 Consensus Guideline, or by the date on which these standards are required by European authorities or the FDA to be implemented, whichever is the earlier. Both Parties will execute and implement a detailed pharmacovigilance agreement pertaining to Products no later than **** before the earlier of the following events: (i) BI or Vitae is physically and/or legally able to distribute Products in the market, in a clinical trial or for whatever purpose, or (ii) BI or Vitae has a Marketing Authorisation Approval, a clinical trial authorisation, or has regulatory reporting obligations for any other reason.
Drug Safety Information. Lepu shall comply fully with all applicable Adverse Event reporting recommendations and requirements in all countries in the Territory where Xxxx intends to Commercialize the Product and the Parties agree to exchange with one another such information as may be necessary to achieve that end and to ensure that the Parties are completely informed regarding Adverse Events with respect to the Products. This includes single case reports, together with an appropriate medical evaluation, as well as aggregate data, such as Periodic Safety Update Reports (PSURs) required by applicable Regulatory Authorities. Within [***] after the Effective Date of this Agreement, the Parties shall commence good faith negotiations on a mutually acceptable pharmacovigilance agreement.
Drug Safety Information. As soon as reasonably necessary, the Parties shall enter into a pharmacovigilance and global safety reporting agreement reasonably acceptable to both Parties in respect of any Products. As between Genentech and Altus, Genentech shall be responsible for maintenance of the global safety database and global safety monitoring, except to the extent prohibited by Law.
