Exchange of Drug Safety Information. The Parties shall have the rights and responsibilities pertaining to AEs, SAEs and biologic product deviations in accordance with the provisions of the Quality Agreement attached hereto as Exhibit D.
Exchange of Drug Safety Information. Within ninety (90) days after the ----------------------------------- Effective Date, the Parties shall enter into the Pharmacovigilance Agreement. Each Party shall ensure that, in the Development or Commercialization of the Collaboration Products, it and each of its respective Affiliates will record, investigate, summarize, notify, report and review all Adverse Drug Experiences in accordance with Law and the Pharmacovigilance Agreement. Each Party shall require that such Affiliates (i) adhere to all requirements of applicable Laws which relate to the reporting and investigation of Adverse Drug Experiences, and (ii) keep the Parties informed of such events.
Exchange of Drug Safety Information. Subject to and upon completion of appropriate Safety Exchange requirements and/or transfer of all appropriate safety data identified and agreed by the Parties under Section 4.2 (and which would then form part of the Specific Alliance Product Development & Commercialization Appendix for same), at the time a Theravance Compound becomes an Alliance Product under this Agreement GSK shall be responsible for recording, investigating, summarizing, notifying, reporting and reviewing all Adverse Drug Experiences in relation to Alliance Products in accordance with Law and 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 Joint Program Committee apprised on a regular basis of such matters arising therefrom.
Exchange of Drug Safety Information. (a) Clinigen shall be responsible for recording, investigating, summarizing, notifying, reporting and reviewing all Adverse Drug Experiences in the Territory in accordance with applicable Laws and shall require that its Affiliates, sublicensees and subcontractors (i) adhere to all requirements of applicable Laws that relate to the reporting and investigation of Adverse Drug Experiences in the Territory, and (ii) inform the Joint Steering Committee promptly of such matters arising therefrom.
(b) Theravance shall notify Clinigen as soon as practicable of all “adverse reactions”, “serious adverse reactions” and “unexpected adverse reactions” as such terms are defined in Directive 2001/83/EC and all “adverse events,” “adverse experiences” and “adverse drug reactions” as such terms are defined in ICH E2A that occur outside the Territory to enable Clinigen to comply with the Guideline on good pharmacovigilance practices (GVP) Module VI — Management and reporting of adverse reactions to medicinal products.
Exchange of Drug Safety Information. Subject to the second sentence of this Section 8.3, GSK shall be responsible for recording, investigating, summarizing, notifying, reporting and reviewing all Adverse Drug Experiences in accordance with Law and 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 Joint Project Committee apprised on a regular basis of such matters arising therefrom. The foregoing shall be subject to any of Theravance's own clinical safety obligations mandated by Law as a result of its ongoing Development activity related to TD-3327 (as such activity is more specifically referred to in Article 4) and, in acknowledgement of this, it is thereby contemplated that the Parties' respective clinical safety groups may need to discuss and agree, at the appropriate time after the Effective Date, appropriate safety data exchange procedures related to same.
Exchange of Drug Safety Information. Each Party shall promptly inform the other Party of any AEs of which such first Party, or any of its Affiliates becomes aware. BSC shall record, investigate, summarize and review any AEs. Each Party shall, and shall require that its Affiliates, (i) adhere to all requirements of applicable Laws which relate to the reporting and investigation of AEs, and (ii) keep the other Party informed of such experiences.
Exchange of Drug Safety Information. The Parties shall immediately provide each other with copies of all drug or device safety requests from all governmental and other Regulatory Authorities. Proposed answers affecting a Product or Injection Catheter will be exchanged between the Parties before submission, and the Parties shall cooperate with respect to such answers; provided, however, that the Company shall have the ultimate decision making authority with respect to answers relating to the Products, and BSC shall have the ultimate decision making authority to answers relating to the Injection Catheters. Each Party shall provide the other Party with the decisions received from the applicable Regulatory Authorities reasonably promptly after the Party receives notice of such decision.
Exchange of Drug Safety Information. Each Party shall promptly inform the other Party of any AEs and SAEs of which such first Party, or any of its Affiliates or Sublicensees becomes aware. Via their participation in the Project Team, the Parties shall decide which Party shall record, investigate, summarize and review any AEs and SAEs. Each Party shall, and shall require that its Sublicensees and Affiliates, (i) adhere to all requirements of applicable laws and regulations which relate to the reporting and investigation of AEs and SAEs, and (ii) keep the other Party informed of such experiences.
Exchange of Drug Safety Information. Cephalon shall have the sole responsibility for investigating and reporting to Governmental Authorities all Adverse Drug Experiences for the Product in accordance with Law. XxXxxx shall have the responsibility for promptly forwarding to Cephalon, as reasonably instructed by Cephalon, any and all reports received by XxXxxx of Adverse Drug Experience of the Product, which reports shall be investigated by Cephalon. Cephalon shall ensure that, in the Co-Promotion and Detailing of the Product, it will record, investigate, summarize, notify, report and review all Adverse Drug Experiences in accordance with Law. Each Party shall require that such Affiliates (a) adhere to all requirements of applicable Laws which relate to the reporting and investigation of Adverse Drug Experiences by such Party, and (b) keep the Parties informed of such events, in each case with respect to the Product.
Exchange of Drug Safety Information. The IND holder shall be responsible for recording, investigating, summarizing and reviewing any AEs and SAEs (including SUSARs) for the applicable Product. Each Party shall, and shall require that its sublicensees and Affiliates, (i) adhere to all requirements of applicable laws and regulations that relate to the reporting and investigation of AEs, SAEs and SUSARs, and (ii) keep the other Party informed of such experiences and any reporting to Regulatory Agencies with regard thereto.
