Clinical Trial Reports Sample Clauses

Clinical Trial Reports. Without limiting any of Licensee’s obligations under this Agreement, Licensee shall be responsible for preparing the clinical trial yearly progress reports, clinical trial final report and any other reports as may be required by a Regulatory Authority in connection with clinical trials of the Licensed Product; provided, however that Licensee shall provide drafts of such reports for Licensor’s knowledge prior to submission to the applicable Regulatory Authority and provide all final reports submitted to applicable Regulatory Authorities.

Clinical Trial Reports. Should any Party or its affiliates conduct clinical trials with BEXXAR therapy or provide BEXXAR therapy for named patient use, GlaxoSmithKline Canada and Corixa will exchange AE data (foreign and domestic) according to the timelines below: ----------------------------------------------------------------------------------------------------------------------- ADVERSE EVENT TYPE (INITIAL AND FOLLOW-UP REPORTS) GLAXOSMITHKLINE CANADA TO CORIXA ----------------------------------------------------------------------------------------------------------------------- Serious attributable fatal or 24 hours or within 3 calendar days if this period includes a life-threatening AEs weekend or public holiday ----------------------------------------------------------------------------------------------------------------------- All other SAEs and pregnancies 48 hours or within 3 calendar days if this period includes a weekend or public holiday ----------------------------------------------------------------------------------------------------------------------- Non-serious AEs from named 5 calendar days patients/compassionate use ----------------------------------------------------------------------------------------------------------------------- Non-serious AEs from clinical studies not required to send to Corixa ----------------------------------------------------------------------------------------------------------------------- ----------------------------------------------------------------------------------------------------------------------- ADVERSE EVENT TYPE (INITIAL AND FOLLOW-UP REPORTS) CORIXA TO GLAXOSMITHKLINE CANADA ----------------------------------------------------------------------------------------------------------------------- Serious attributable unexpected fatal or 5 calendar days life-threatening AEs ----------------------------------------------------------------------------------------------------------------------- All other serious attributable unexpected 12 calendar days AEs ----------------------------------------------------------------------------------------------------------------------- Redacted

Clinical Trial Reports. 8.1 Licensee will forward to Cellegy any Serious or Unexpected Adverse Drug Event report that is considered to be drug related and occurs during clinical trials within 72 hours of receipt of such report by Licensee. 8.2 Any Serious Adverse Drug Event report based upon clinical trials forwarded to Cellegy according to clause 8.1 will: (a) be reported on the Serious Adverse Event form from the case report form; (b) include an assessment of causality by the investigator with an indication on the case report form; and (c) if blinded studies are carried out, a disclosure of the randomization code by a person not directly involved in the study if it is ongoing, in order to permit entry of that data into a central database. 8.3 Licensee will forward to Cellegy any Non-serious Adverse Drug Event report from clinical trials as part of the end of study reports, provided however, that at least the safety sections of the end of study reports will be forwarded to Cellegy within 30 days of completion of the end of study reports. 8.4 All reports from Licensee on Adverse Drug Events from clinical trials shall be addressed to Cellegy as follows: Cellegy Pharmaceuticals, Inc. 349 Oyster Point Boulevard San Francisco, California 9▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇.: (▇▇▇) ▇▇▇-▇▇▇▇ ▇▇▇▇▇▇▇▇e No.: (650) 616-2222 ▇.▇ ▇▇▇▇▇▇▇ will acknowledge receipt of any s▇▇▇ ▇▇▇▇▇▇ ▇▇▇hin 5 days of that receipt.

Clinical Trial Reports. 8.1 Licensee will forward to Cellegy any Serious or Unexpected Adverse Drug Event report that is considered to be drug related and occurs during clinical trials within 72 hours of receipt of such report by Licensee. 8.2 Any Serious Adverse Drug Event report based upon clinical trials forwarded to Cellegy according to clause 8.1 will: (a) be reported on the Serious Adverse Event form from the case report form; (b) include an assessment of causality by the investigator with an indication on the case report form; and (c) if blinded studies are carried out, a disclosure of the randomization code by a person not directly involved in the study if it is ongoing, in order to permit entry of that data into a central database. 8.3 Licensee will forward to Cellegy any Non-serious Adverse Drug Event report from clinical trials as part of the end of study reports, provided however, that at least the safety sections of the end of study reports will be forwarded to Cellegy within 30 days of completion of the end of study reports. 8.4 All reports from Licensee on Adverse Drug Events from clinical trials shall be addressed to Cellegy as follows: Cellegy Pharmaceuticals, Inc. 3▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇ ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ Telephone No.: (▇▇▇) ▇▇▇-▇▇▇▇ Facsimile No.: (▇▇▇) ▇▇▇-▇▇▇▇ 8.5 Cellegy will acknowledge receipt of any such report within 5 days of that receipt.