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. 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. 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. 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. 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. Immtech shall be responsible for screening published scientific and medical literature for ADEs/ICSRs. BioAlliance shall be responsible for notifying Immtech of any relevant ADEs/ICSR that may come to its attention in BioAlliance 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. 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.
Literature Reports. DUSA shall be responsible for regularly screening (i.e., bimonthly (every two months)) the worldwide published scientific and medical literature by accessing widely used systematic literature reviews or reference database(s). Reports of ICSRs or pregnancy reports that appear either as case reports or as the result of a formal clinical trial, or significant unexpected in vitro, animal or human (clinical; epidemiological) study safety findings or aggregate data from studies suggesting significant risk to humans (e.g., mutagenicity, teratogenicity or carcinogenicity) and which are associated with the use of Levulan(R) Kerastick(R) or of its active constituent(s) qualify for processing. XXXXXXX shall also conduct this screening on a weekly basis and provide any relevant literature to DUSA. DUSA shall include such literature in its database. Note: Certain portions of this document have been marked "[C.I.]" to indicate that confidential treatment has been requested for this confidential information. The confidential portions have been omitted and filed separately with the Securities and Exchange Commission. Each Party is responsible for notifying the other Party, in accordance with the time frames stipulated in Section IV.B., of any relevant ICSR, pregnancy report, study safety finding or aggregate data that may come to its attention via an unpublished scientific or conference paper. A copy of the unpublished paper shall also be provided, and an English translation (if the article is in a non English language), if available.
