Literature Reports. Each party shall handle literature reports in a manner similar to that described for reports of SADRs and non-serious ADRs from commercial/spontaneous use. Reportable cases from a literature survey in a Novartis Territory shall be sent with a citation and summary in English via electronic mail in PDF format. Likewise GW Pharma shall send to Novartis literature articles from reportable cases via electronic mail in PDF format with a citation and summary in English, if the original literature is written in other than English. The Company Receipt date will be the date of receipt of the article/citation, and translations will be classed as follow-up information.
Literature Reports. Somaxon shall be responsible for screening published scientific and medical literature for individual case safety reports related to the Licensed Product within and outside the Territory.
Literature Reports. Aptalis will monitor local US literature and Strakan will monitor global literature. Each Party will generate individual case safety reports (ICSR) accordingly. All AE/ADR reports will be processed and exchanged in the same manner as spontaneous reports as described in Section 5.3 above. An abstract of the article in English shall be provided with the report. Such abstract shall contain sufficient information to determine case reportability and provide a quality ICSR.
Literature Reports. Alfacell shall be responsible for screening published scientific and medical literature for ADEs/ICSRs related to the Product in the Field. A copy of any such relevant literature reports and/or articles shall be promptly provided to the other Party. To the extent of additional obligations contained in Section 8.1.3 of the Supply Agreement, such obligations are hereby incorporated by reference herein.
Literature Reports. Xxxxxx shall be responsible for screening published scientific and medical literature for individual case safety reports related to the Products in the Territory. Theratechnologies or any of its Affiliates shall be responsible for screening published scientific and medical literature for individual case safety reports related to the Products outside the Territory.
Literature Reports. CUMBERLAND will have the primary responsibility for reviewing domestic medical literature for potential AEs related to any of the components of the Product. Should the search result in an AE, CUMBERLAND will prepare the MedWatch form FDA3500A, and, in the case of an SAE, GEL will prepare the 15-day alert cover letter ready for submission by GEL within five (5) business days of CUMBERLAND’s Initial Awareness Date of the literature based SAE.
Literature Reports. From the Marketing Approval of a Product in the Territories, Theratechnologies shall be responsible for screening published scientific and medical literature for individual case safety reports related to such Product in the Territories. TaiMed shall be responsible for screening published scientific and medical literature for individual case safety reports related to a Product before the Marketing Approval of such Product and outside the Territories.
Literature Reports. Alfacell shall be responsible for screening published scientific and medical literature for Adverse Events or ICSRs. Par shall be responsible for notifying Alfacell of any relevant Adverse Events or ICSRs that may come to its attention in the Territory via local scientific or medical journals, or unpublished scientific or conference papers. A copy of any such documentation shall be provided at the same time as the report.
Literature Reports. Immtech shall be responsible for screening published scientific and medical literature for ADEs/ICSRs. Par shall be responsible for notifying Immtech of any relevant ADEs/ICSR that may come to its attention in Par Territory via local scientific or medical journals, or unpublished scientific or conference papers. A copy of the article shall be provided at the same time as the report.
Literature Reports. 7 G. Product Complaints Associated with an ICSR or Pregnancy Report.......................................................... 8 H. Internet........................................................ 8 I.
