Responsibility Before First Commercial Sale Sample Clauses
Responsibility Before First Commercial Sale. Prior to the First Commercial Sale of a Licensed Product in the Field in the Territory or the European Union, AEVI will hold and manage the safety database and will lead safety monitoring and reporting in the Territory and the European Union, and KKC will hold and manage the safety database during clinical development and will lead safety monitoring and reporting outside the Territory and outside the European Union. Each Party will allow the other Party and its Affiliates and sublicensees or Third Parties acting on their respective behalf, to:
(a) review all serious adverse events within time frames that comply with 21 CFR 312.32;
(b) review IND safety reports, investigator brochure amendments, patient consent forms and clinical protocols;
(c) review monthly line listings;
(d) read and write to the database;
(e) participate in signaling discussions; and
(f) review all periodic reporting required by Regulatory Authorities (e.g., IND Annual Reports, EU Annual Safety Reports, etc.). The Parties agree to jointly develop and enter into a global safety data exchange and pharmacovigilance agreement to facilitate this exchange of information no later than (***) prior to the date of initiation of the first clinical study sponsored by KKC if and when KKC decides to Develop the Licensed Product in its jurisdiction. In such case, AEVI will be responsible for holding and maintaining the global safety database for the Licensed Product.
Responsibility Before First Commercial Sale. Prior to the First Commercial Sale of a Licensed Product anywhere in the world, whether inside or outside the Field, AEVI will hold and manage a safety database and will lead safety monitoring and reporting in the Field in the Territory, and when KKC conducts any clinical trials for the Licensed Product, KKC will hold and manage a safety database during clinical development and will lead safety monitoring and reporting outside the Field in the Territory. Each Party will allow the other Party and its Affiliates and sublicensees or Third Parties acting on their respective behalf, to:
(a) review all serious adverse events within time frames that comply with 21 CFR 312.32;
(b) review IND safety reports, investigator brochure amendments, patient consent forms and clinical protocols;
(c) review monthly line listings;
(d) read and write to each Party’s database;
(e) participate in signaling discussions; and
(f) review all periodic reporting required by Regulatory Authorities (e.g., IND Annual Reports, EU Annual Safety Reports, etc.). The Parties agree to jointly develop and enter into a global safety data exchange and pharmacovigilance agreement to facilitate this exchange of information no later than (***) prior to the date of initiation of the first clinical study sponsored by KKC if and when KKC decides to Develop the Licensed Product outside the Field. In such case, AEVI will be responsible for holding and maintaining the global database for the Licensed Product.
Responsibility Before First Commercial Sale. Prior to the First Commercial Sale of a Licensed Product anywhere in the world, whether inside or outside the Field, Medgenics will hold and manage a safety database and will lead safety monitoring and reporting in Field in the Territory, and when KHK conducts any clinical trials for the Licensed Product, KHK will hold and manage a safety database during clinical development and will lead safety monitoring and reporting outside the Field in the Territory and outside the Territory. Each Party will allow the other Party and its Affiliates and sublicensees or Third Parties acting on their respective behalf, to:
(a) review all serious adverse events within time frames that comply with 21 CFR 312.32; ***** Confidential Information has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to this omitted information.
(b) review IND safety reports, investigator brochure amendments, patient consent forms and clinical protocols;
(c) review monthly line listings;
(d) read and write to each Party’s database;
(e) participate in signaling discussions; and
(f) review all periodic reporting required by Regulatory Authorities (e.g., IND Annual Reports, EU Annual Safety Reports, etc.). The Parties agree to jointly develop and enter into a global safety data exchange and pharmacovigilance agreement to facilitate this exchange of information no later than ***** prior to the date of initiation of the first clinical study sponsored by KHK if and when KHK decides to Develop the Licensed Product in its jurisdiction. In such case, Medgenics will be responsible for holding and maintaining the global database for the Licensed Product.