Transmission of SAEs. Company will transmit to Merck all serious adverse events (“SAEs”) as follows:
5.2.1. For drug-related fatal and life-threatening SAEs, Company will send a processed case (on a CIOMS-1 form in English) within [*****] calendar days after receipt by Company of such SAEs.
5.2.2. For all other SAEs, including non-drug-related fatal and life-threatening SAEs, Company will send a processed case (on a CIOMS-1 form in English) within [*****] calendar days after receipt by Company of such SAEs.
Transmission of SAEs. Collaborator will transmit to MSD all SAEs from the MSD Compound Study as set forth below. All cases will be transmitted on a CIOMS-1 form in English.
5.2.1. For fatal and life-threatening SAEs, Collaborator will transmit a processed case within [***] days after receipt by Collaborator of notice of such SAEs.
5.2.2. For all other SAEs and newly diagnosed cancer, Collaborator will transmit a processed case within [***] days after receipt by Collaborator of notice of such SAEs.
5.2.3. Cases of disease progression will be handled as outlined in the Protocol, and if the Protocol specifies that such cases are collected as SAEs, Collaborator will transmit such cases to MSD within the applicable timeframe set forth in Section 5.2.1 or Section 5.2.2.
5.2.4. For all other reportable information that includes: (i) overdose, exposure during pregnancy or lactation; and (ii) cases of potential drug-induced liver injury where the patient was exposed to the MSD Compound (if required to be collected or identified per the Protocol), Collaborator will transmit a processed case within [***] days after receipt by Collaborator of such information.
Transmission of SAEs. Adaptimmune will transmit to Merck by fax or secure email notification as set forth in the Pharmacovigilance Agreement all serious adverse events (“SAEs”) as follows:
5.2.1. For drug-related fatal and life-threatening SAEs, Adaptimmune will send a completely processed case (on a CIOMS-1 form in English) within *** calendar days after receipt by Adaptimmune of such SAEs.
5.2.2. For all other SAEs, including non-drug-related fatal and life-threatening SAEs, Adaptimmune will send a completely processed case (on a CIOMS-1 form in English) within *** calendar days after receipt by Adaptimmune of such SAEs.
Transmission of SAEs. Antigen Express will transmit to Merck all serious adverse events (“SAEs”) as follows:
5.2.1. For drug-related fatal and life-threatening SAEs, Antigen Express will send a completely processed case (on a CIOMS-1 form in English) within three (3) calendar days after receipt by Antigen Express of such SAEs.
5.2.2. For all other SAEs, including non-drug-related fatal and life-threatening SAEs, Antigen Express will send a completely processed case (on a CIOMS-1 form in English) within five (5) calendar days after receipt by Antigen Express of such SAEs.
Transmission of SAEs. FLX will transmit to Merck all serious adverse events (“SAEs”) [***]:
5.2.1. For drug-related fatal and life-threatening SAEs, FLX will send a processed case (on a CIOMS-1 form in English) within [***] by FLX of such SAEs.
5.2.2. For all other SAEs, including non-drug-related fatal and life-threatening SAEs, FLX will send a processed case (on a CIOMS-1 form in English) within [***] by FLX of such SAEs.
Transmission of SAEs. Company will transmit to MSD all SAEs from the Study as set forth below. All cases will be transmitted on a CIOMS-1 form in English.
5.2.1. For drug-related fatal and life-threatening SAEs, Company will transmit a processed case within [***] calendar days after receipt by Company of notice of such SAEs.
5.2.2. For all other SAEs, including non-drug-related fatal and life-threatening SAEs, and newly diagnosed cancer, Company will transmit a processed case within [***] calendar days after receipt by Company of notice of such SAEs.
5.2.3. Cases of disease progression will be handled as outlined in the Protocol, and if the Protocol specifies that such cases are collected as SAEs, Company will transmit such cases to MSD within the applicable timeframe set forth in Section 5.2.1 or Section 5.2.2.
5.2.4. For all other reportable information that includes: (i) overdose, exposure during pregnancy or lactation; and (ii) cases of potential drug-induced liver injury where the patient was exposed to the MSD Compound (if required to be collected or identified per the Protocol), Company will transmit a processed case within [***] calendar days after receipt by Company of such information.
Transmission of SAEs. Collaborator will transmit to MSD all SAEs from the MSD Compound Study as set forth below. All cases will be transmitted on a CIOMS-1 form in English.
5.2.1. For fatal and life-threatening SAEs, Collaborator will transmit a processed case within [***] after receipt by Collaborator of notice of such SAEs.
5.2.2. For all other SAEs and newly diagnosed cancer, Collaborator will transmit a processed case within [***] after receipt by Collaborator of notice of such SAEs.
5.2.3. Cases of disease progression will be handled as outlined in the Protocol, and if the Protocol specifies that such cases are collected as SAEs, Collaborator will transmit such cases to MSD within the applicable timeframe set forth in Section 5.2.1 or Section 5.2.2.
5.2.4. For all other reportable information that includes: (i) overdose, exposure during pregnancy or lactation; and (ii) cases of potential drug-induced liver injury where the patient was exposed to the MSD Compound (if required to be collected or identified per the Protocol), Collaborator will transmit a processed case within [***] after receipt by Collaborator of such information.
Transmission of SAEs. Intensity will transmit to MSD all serious adverse events (“SAEs”) as follows:
5.2.1. For drug-related fatal and life-threatening SAEs, Intensity will send a processed case (on a CIOMS-1 form in English) within [***] after receipt by Intensity of such SAEs.
5.2.2. For all other SAEs, including non-drug-related fatal and life-threatening SAEs, Intensity will send a processed case (on a CIOMS-1 form in English) within [***] after receipt by Intensity of such SAEs.
Transmission of SAEs. Pursuant to such Pharmacovigilance Agreement, Merck will transmit to Company all serious adverse events (“SAEs”) as follows:
5.2.1. For Company Compound fatal and life-threatening SAEs, Merck will send processed CIOMS-1 forms (in English) within five (5) calendar days after receipt by Merck of such SAEs.
5.2.2. For all other Company Compound SAEs, including non-drug-related fatal and life-threatening SAEs, Merck will send processed CIOMS-1 forms (in English) within seven (7) calendar days after receipt by Company of such SAEs.
Transmission of SAEs. Rexahn will transmit to Merck all serious adverse events (“SAEs”) as follows:
5.2.1 For drug-related fatal and life-threatening SAEs, Rexahn will send a processed case (on a CIOMS-1 form in English) [***] by Rexahn of such SAEs.
5.2.2 For all other SAEs, including non-drug-related fatal and life-threatening SAEs, Rexahn will send a processed case (on a CIOMS-1 form in English) [***] by Rexahn of such SAEs.
