Common use of Safety Evaluation Clause in Contracts

Safety Evaluation. Each Party shall provide the following information with respect to its Compound to be used in a Combined Therapy Study: (i) the latest investigator’s brochure and annual updates (with such updates to be provided within five (5) Business Days after being finalized), (ii) list of ongoing clinical studies, (iii) Aggregate Safety Information that emerge from all other clinical trials of the Party’s Compound within five (5) Business Days after general distribution within such Party, (iv) prompt notice of any material safety interactions with any Regulatory Authority and the substance thereof regarding any clinical trials of the Party’s Compound during the term of this Agreement; (v) a summary of all new clinically relevant toxicology study data on the Party’s Compound within five (5) Business Days after generation of such summary within such Party, (vi) safety analyses for the Combined Therapy Study in accordance with the applicable Statistical Analysis Plan, and (vii) such other safety data as set forth in the Pharmacovigilance Agreement. Except as permitted under Section 8.3(g) and Section 8.4, each Party shall use any such information provided by the other Party pursuant to this Section 2.1(g) solely to evaluate the safety of the Combined Therapy and the Compounds for use in the Combined Therapy Study.

Safety Evaluation. Each Party shall provide the following information with respect to its Compound to be used in a Combined Therapy StudyCompound: (i) the latest investigator’s brochure and annual updates (with such updates to be provided within five (5) Business Days after being finalized), (ii) list of ongoing clinical studies, (iii) Aggregate Safety Information that emerge from all other clinical trials of the Party’s Compound within five (5) Business Days after general distribution within such Party, ; (iv) prompt notice of any material safety interactions with any Regulatory Authority and the substance thereof regarding any clinical trials of the Party’s Compound during the term of this Agreement; (v) a summary of all new clinically relevant toxicology study data on the Party’s Compound within five (5) Business Days after generation of such summary within such Party, ; (vi) safety analyses for the Combined Therapy Study in accordance with the applicable Statistical Analysis Plan, Plan and (vii) such other safety data as set forth in the Pharmacovigilance Agreement. Except as permitted under Section 8.3(g8.5(c)(v) and Section 8.48.6(c)(v), each Party shall use any such information provided by the other Party pursuant to this Section 2.1(g) solely to evaluate the safety of the Combined Therapy and the Compounds for use in the Combined Therapy Study.

Safety Evaluation. Each Party shall provide the following information with respect to its Compound to be used in a Combined Therapy StudyCompound: (i) the latest investigator’s brochure and annual updates (with such updates to be provided within five (5) Business Days after being finalized), (ii) list of ongoing clinical studies, (iii) Aggregate Safety Information that emerge from all other clinical trials of the Party’s Compound within five (5) Business Days after general distribution within such Party, ; (iv) prompt notice of any material safety interactions with any Regulatory Authority and the substance thereof regarding any clinical trials of the Party’s Compound during the term of this Agreement; (v) a summary of all new clinically relevant toxicology study data on the Party’s Compound within five (5) Business Days after generation of such summary within such Party, ; (vi) safety analyses for the Combined Therapy Study in accordance with the applicable Statistical Analysis Plan, Plan and (vii) such other safety data as set forth in the Pharmacovigilance Agreement. Except as permitted under Section 8.3(g8.5(b)(iv) and Section 8.48.6(b)(iv), each Party shall use any such information provided by the other Party pursuant to this Section 2.1(g) solely to evaluate the safety of the Combined Therapy and the Compounds for use in the Combined Therapy Study.