Pharmacovigilance; Safety Data Reporting. The collaboration between the Parties may involve exchanging safety information and adverse events for the Licensed Product(s). Therefore, the Parties agree to enter into negotiations to set up, if required, a detailed safety data exchange agreement (the “SDEA”) in due time (i.e., prior to the start of clinical development by SANOFI-AVENTIS) to arrange the pharmacovigilance database transfer to SANOFI-AVENTIS (if applicable) and any future pharmacovigilance exchange between the Parties when relevant (e.g., in the case where Merrimack is sponsoring clinical studies or co-developing Licensed Product(s)). Each Party shall ensure, through its JDC representatives or designated personnel, that the competent pharmacovigilance groups or personnel from such Party begin to negotiate and establish the appropriate SDEA no later than [**] months before SANOFI-AVENTIS commences clinical development hereunder. The SDEA shall be negotiated in good faith between the pharmacovigilance departments of each Party. The SDEA shall define the roles and responsibilities of both Parties in terms of pharmacovigilance and define the detailed safety exchange required to permit compliance by both Parties with safety reporting requirements to Regulatory Authorities and other entities in the respective Territories and ensure worldwide safety surveillance.
Pharmacovigilance; Safety Data Reporting. The collaboration between the Parties may involve exchanging safety information and adverse event information for the Licensed Product. Therefore, the Parties agree to enter into negotiations to set up a detailed safety data exchange agreement (the “SDEA”) in due time (i.e., prior to the start of any Clinical Trial by MERRIMACK), under which MERRIMACK shall be responsible for the worldwide safety database for the Licensed Product, to govern any future pharmacovigilance exchange between the Parties when relevant (e.g., in the case where PEI is sponsoring Clinical Trials). Each Party shall ensure, through its JDC representatives or designated personnel, that the competent pharmacovigilance groups or personnel from such Party begin to negotiate and establish the appropriate SDEA no later than [**] months before MERRIMACK commences clinical development hereunder. The SDEA shall be negotiated in good faith between the pharmacovigilance departments of each Party. The SDEA shall define the roles and responsibilities of both Parties in terms of pharmacovigilance and define the detailed safety exchange required to permit compliance by both Parties with safety reporting requirements to Regulatory Authorities and other entities in the respective licensed territories and ensure worldwide safety surveillance.
Pharmacovigilance; Safety Data Reporting. The collaboration between the Parties may involve exchanging safety information and adverse events for the Licensed Product(s). Therefore, the Parties agree to enter into negotiations to promptly set up, within [**] following the Effective Date, a detailed safety data exchange agreement (the “SDEA”) setting forth the procedures governing the coordination of collection, investigation, reporting and exchange of information to enable collaboration on all matters of safety of use of the Licensed Product worldwide including the exchange of Adverse Drug Reactions information and similar matters sufficient to permit each Party to comply with its legal obligations (including, to the extent applicable, those obligations contained in ICH guidelines E2A, E2B and E2C). The SDEA shall also set forth the location and responsibility for holding the global pharmacovigilance database, which shall be maintained by Lexicon and established as soon as reasonably feasible to enable the Parties to comply with the international requirements and regulations and monitor the patients’ safety (e.g., IB, ASR or its replacement, PSUR). The SDEA shall be negotiated in good faith between the pharmacovigilance departments of each Party. The SDEA, which shall define the roles and responsibilities of both Parties in terms of pharmacovigilance and define the detailed safety exchange required to permit compliance by both Parties with safety reporting requirements to Regulatory Authorities and other entities and ensure worldwide safety surveillance, shall provide among other things that Lexicon shall not transfer the responsibility or holding of the global pharmacovigilance database to any sublicensee, CRO or any Third Party without Xxxxx’x express consent and approval, which shall not be unreasonably withheld or delayed if such transferee (together with its Affiliates) is a pharmaceutical company of comparable size as (or greater size than) Ipsen and agrees to xxxxx Xxxxx access and other rights to the global pharmacovigilance database substantially equivalent to those granted by Lexicon under the SDEA. The use by Lexicon of a Sublicensee, a CRO or any Third Party shall be at Lexicon’s sole cost and expense.
Pharmacovigilance; Safety Data Reporting
