Safety Databases. Upon NDA Assignment, Collegium (or its agent) will maintain a pharmacovigilance database for each Licensed Product in the Territory (or each country thereof, if/as applicable). The database(s) will include all ADE reports from spontaneous sources, scientific literature, and PMS reports (serious) and SAE reports from clinical studies coming into the actual knowledge of Collegium, its Affiliates, or any Sublicensee (or any agent of the foregoing). Spontaneous cases will include reports received from both healthcare professionals and consumers. AE data will be coded to the latest version of MedDRA. Report handling and classifying will be carried out in accordance with Collegium’s (or its agent’s) SOPs (as defined below). All reasonable assistance and access requested by either Party in responding to safety inquiries will be provided upon request. Information in Collegium’s safety databases will be used by Collegium to compile PSURs (as defined below) to the FDA (providing a waiver of the requirement to submit postmarketing periodic safety reports in the format described in the regulations has been granted) and other Competent Authorities in the Territory and prepare safety-related supplemental applications for changes in the package insert(s)/labelling for Licensed Products in the Territory.
Safety Databases. Partner will maintain a safety database in English for Clinical Trials for the Licensed Product conducted in the Territory under a Territory Development Plan, at its sole cost and expense. Partner will be responsible for: (a) reporting to the applicable Regulatory Authorities in the Territory all quality complaints, adverse events, and safety data related to the Licensed Product for all Territory-Specific Clinical Trials or Global Clinical Trials conducted in the Territory; and (b) responding to safety issues and to all requests of Regulatory Authorities related to the Licensed Product in the Territory. Partner will provide Kiniksa (i) real-time access to Partner’s safety database for the Licensed Product in the Territory, and (ii) upon Kiniksa’s request, query results from Partner’s safety database for the Licensed Product. As between the Parties, Kiniksa will maintain a global safety database for Global Clinical Trials for the Licensed Product conducted under each Global Development Plan at Kiniksa’s cost and expense.
Safety Databases. As between the Parties, Licensor or its designee will maintain a global safety database for Clinical Trials for the Licensed Products, including those Clinical Trials conducted under a Japanese Clinical Development Plan. Licensor will be responsible for: (a) reporting to the applicable Regulatory Authorities in the territory of Japan all quality complaints, adverse events, and safety data related to such Licensed Product for all Clinical Trials conducted under a Japanese Clinical Development Plan; and (b) responding to safety issues and to all requests of Regulatory Authorities related to such Licensed Product and any Japanese Clinical Development Plan. Licensee will be responsible for reporting and responding to all quality complaints, adverse events, and safety data related to such Licensed Product for all Clinical Trials conducted under a Japanese Clinical Development Plan. Licensee and its Affiliates and Sublicensees, at the sole cost and expense of Licensee, will (i) host and maintain a local safety database capable of transmitting reports to Licensor using ICH E2B Guidance and (ii) provide to Licensor, promptly after receipt thereof, all safety reports regarding the Licensed Products in the territory of Japan, and Licensee acknowledges and agrees that Licensor will have the right to include in the global safety database such safety reports and other information provided by Licensee or its Affiliates or Sublicensees related to the safety of the Licensed Products. Upon Licensee’s request, Licensor will (or will cause its designee to) query results from the global safety database for each Licensed Product. 5.7
Safety Databases. Specify the safety databases to be used by both parties for storing and managing safety data, ensuring compliance with regulatory standards. Reconciliation method and frequency: Outline the method and frequency of data reconciliation between parties to ensure consistency and accuracy of safety data. XXXX://XXX.XXXXXXXX.XXX/IN/KIRAN-PAWAR-6043A9187 Handling of safety-related recalls: Define procedures for handling safety-related recalls, including communication strategies, regulatory notifications, and coordination between parties. Data privacy and confidentiality clauses: Incorporate clauses to ensure the privacy and confidentiality of safety data, including measures for data encryption, access control, and compliance with applicable data protection laws. Business continuity plans: Detail business continuity plans to ensure uninterrupted pharmacovigilance activities in case of emergencies or disruptions. Termination clauses: Specify conditions and procedures for termination of the agreement, including obligations upon termination and transition of pharmacovigilance activities. XXXX://XXX.XXXXXXXX.XXX/IN/KIRAN-PAWAR-6043A9187 SDEA revision details - when and how: Define the process for revising the SDEA, including triggers for revision, approval mechanisms, and notification procedures. Responsibilities during regulatory inspections for PV: Outline responsibilities of both parties during regulatory inspections related to pharmacovigilance activities, including cooperation, document preparation, and response strategies. Auditing: Define procedures for conducting audits of pharmacovigilance activities, including frequency, scope, and reporting requirements. Contact details such as phone no, email ID for communication of safety information: Provide contact details for designated points of contact at both parties for communication of safety information, including emergency contact information. XXXX://XXX.XXXXXXXX.XXX/IN/KIRAN-PAWAR-6043A9187 Differentiation between Safety Data Exchange Agreements (SDEA) and Pharmacovigilance Agreements XXXX://XXX.XXXXXXXX.XXX/IN/KIRAN-PAWAR-6043A9187 XXXX://XXX.XXXXXXXX.XXX/IN/KIRAN-PAWAR-6043A9187 Conclusion Safety Data Exchange Agreements (SDEAs) serve as the cornerstone of pharmacovigilance efforts in the pharmaceutical industry, enabling stakeholders to collaborate effectively in monitoring and managing the safety of medicinal products. By facilitating the exchange of critical safety information, SDEAs contribute to enhancin...
Safety Databases. Following Governmental Approval, Meda (or its agent) will maintain a pharmacovigilance database for each Licensed Product in the Territory (or each country thereof, if/as applicable). The database (s) will include all ADE reports from spontaneous sources, scientific literature, and PMS reports (serious) and SAE reports from clinical studies coming into the knowledge of Meda Pharmacovigilance Department (or its agent). Spontaneous cases will include reports received from both healthcare professionals and consumers. AE data will be coded to the latest version of MedDRA. Report handling and classifying will be carried out in accordance with Meda’s (or its agent’s) SOPs. All reasonable assistance and access requested by either Party in responding to safety inquiries will be provided upon request. Information in Meda’s safety databases will be used by Meda to compile periodic safety update reports (PSURs) to the FDA (providing a waiver of the requirement to submit postmarketing periodic safety reports in the format described in the regulations has been granted) and other Competent Authorities and prepare safety-related supplemental applications for changes in the package insert(s)/labelling for Licensed Products. CONFIDENTIAL TREATMENT REQUESTED WITH RESPECT TO CERTAIN PORTIONS HEREOF DENOTED WITH “***”
Safety Databases. Partner will maintain a safety database in English for Clinical Trials for the Licensed Products conducted in the Territory under a Territory Development Plan, at its sole cost and expense. Partner will be responsible for: (a) reporting to the applicable Regulatory Authorities in the Territory all quality complaints, adverse events, and safety data related to such Licensed Product for all Territory-Specific Clinical Trials, or Global Clinical Trials conducted in the Territory and for which Partner is Territory Sponsor; and (b) responding to safety issues and to all requests of Regulatory Authorities related to such Licensed Product in the Territory. ImmunoGen may request that run queries of Partner’s safety database for the Licensed Products in the Territory to the extent permitted by law, and (ii) upon ImmunoGen’s request, query results from Partner’s worldwide safety database for each Licensed Product. ImmunoGen will maintain a global safety database for Global Clinical Trials for the Licensed Products conducted under each Global Development Plan [***]. Partner may request that ImmunoGen run queries of such global safety database to the extent required by Applicable Law.
Safety Databases. 7.1 Territory safety database Licensee shall be responsible for the creation, maintenance and update of a safety database related to the use of Licensed Product in the Territory. This database shall be comprised of information from all Reports from Territory. Licensee shall share with Oncolytics an updated version of the safety database not less than quarterly or more frequently as required by Regulatory Authorities.
Safety Databases. Meda will maintain a pan-European pharmacovigilance database for the Licensed Product in the Territory, and BDSI shall use commercially reasonable efforts to materially comply with any comparable obligations or requirements of any applicable laws in the United States. The database concerned includes all Adverse Reaction reports from spontaneous sources, from scientific literature and PMS reports (serious) and Serious Adverse Events reports from clinical studies coming into the knowledge of Meda. Spontaneous cases will include reports received from both healthcare professionals and consumers. Adverse Event data will be coded to the latest version of the Medical Dictionary for Regulatory Activities (“MedDRA”). Report handling and classifying will be carried out in accordance with Meda’s standard operating procedures, which shall be commercially reasonable and consistent with industry standards. All reasonable assistance and access to information, personnel, or Books & Records (other than electronically-direct database access) requested by BDSI in responding to safety inquiries will be provided by Meda upon request. BDSI (or its agent) will maintain a pharmacovigilance database for the Licensed Product in the United States. The database will include all ADR reports from spontaneous sources, from scientific literature and PMS reports (serious) and SAE reports from clinical studies coming into the knowledge of BDSI’s Pharmacovigilance Department (or its agent). Spontaneous cases will include reports received from both healthcare professionals and ***CONFIDENTIAL TREATMENT REQUESTED*** Note: The portions hereof for which confidential treatment are being requested are denoted with “***”. consumers. AE data will be coded to the latest version of MedDRA. Report handling and classifying will be carried out in accordance with BDSI’s (or its agent’s) SOPs. All reasonable assistance and access requested by Meda in responding to safety inquiries will be provided by BDSI upon request.
Safety Databases. Licensor shall be the holder of any global safety database related to any products incorporating the 4D Vector (other than Licensed Products). AGT shall be solely accountable for reporting all safety information required to be submitted to the concerned Regulatory Authorities, ethics committees, institutional review boards or investigators as required by Applicable Laws related to Licensed Products. Where applicable and when applicable, AGT shall be solely responsible for pharmacovigilance activities related to Licensed Products in the respective country(ies) according to Applicable Laws. Licensor shall be solely responsible for reporting all safety information required to be submitted to the concerned Regulatory Authorities, ethics committees, institutional review boards or investigators as required by Applicable Laws related to any products incorporating the 4D Vector (other than the Licensed Product).
Safety Databases. As between the Parties, Licensor or its designee will maintain a global safety database for Clinical Trials for the Licensed Products, including those Clinical Trials conducted under a Territory Development Plan. Licensor will be responsible for: (a) reporting to the applicable Regulatory Authorities in the Territory, except for Chinese Mainland, all quality complaints, adverse events, and safety data related to such Licensed Product for all Clinical Trials conducted under a Territory Development Plan; and (b) responding to safety issues and to all requests of Regulatory Authorities, except in Chinese Mainland, related to such Licensed Product and any Territory Development Plan. Licensee will be responsible for reporting and responding to all quality complaints, adverse events, and safety data related to such Licensed Product for all Clinical Trials conducted under a Territory Development Plan. Licensee and its Affiliates and Sublicensees, at the sole cost and expense of Licensee, will (i) host and maintain a local safety database capable of transmitting reports to Licensor using ICH E2B Guidance and (ii) provide to Licensor, promptly after receipt thereof, all safety reports regarding the Licensed Products in the Territory, and Licensee acknowledges and agrees that Licensor will have the right to include in the global safety database such safety reports and other information provided by Licensee or its Affiliates or Sublicensees related to the safety of the Licensed Products. Upon Licensee’s request, Licensor will (or will cause its designee to) query results from the global safety database for each Licensed Product. 5.7
