Common use of Records, Reports and Information Clause in Contracts

Records, Reports and Information. Each Party shall maintain complete, current and accurate records of all work conducted by it under the Global Product Development Plan, and all data and other Information resulting from such work. Such records shall fully and properly reflect all work done and results achieved in the performance of the Development activities in good scientific manner appropriate for regulatory and patent purposes. Each Party shall document all preclinical studies and clinical trials in formal written study reports according to applicable national and international (e.g., ICH, GCP, GLP, and GMP) guidelines. Each Party shall have the right to review such records maintained by the other Party at reasonable times, upon written request, which shall not exceed [***]. During the Term, on a regular basis, each Party shall present reports at JSC meetings on its Joint Development activities, including without limitation any significant formal or informal meetings between such Party and the applicable Regulatory Authorities, at a level of detail to be agreed upon by the JSC; provided, however, that any such presentation shall include at least a summary of the resulting data for all studies conducted by a Party with the Licensed Product under the Global Product Development Plan, and provided further, upon request from the other Party, such Party conducting the studies shall provide the other Party with a copy of written study reports and access to data underlying any such study report, for use consistent with Articles 4 and 5.

Records, Reports and Information. Each Party shall maintain complete, current and accurate records of all work conducted by it under the Global Product Development Plan, and all data and other Information resulting from such work. Such records shall fully and properly reflect all work done and results achieved in the performance of the Development activities in good scientific manner appropriate for regulatory and patent purposes. Each Party shall document all preclinical studies and clinical trials in formal written study reports according to applicable national and international (e.g., ICH, GCP, GLP, and GMP) guidelines. Each Party shall have the right to review such records maintained by the other Party at reasonable times, upon written request, which shall not exceed [***]. During the Term, on a regular basis, each Party shall present reports at JSC [ *** ] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. meetings on its Joint Development activities, including without limitation any significant formal or informal meetings between such Party and the applicable Regulatory Authorities, at a level of detail to be agreed upon by the JSC; provided, however, that any such presentation shall include at least a summary of the resulting data for all studies conducted by a Party with the Licensed Product under the Global Product Development Plan, and provided further, upon request from the other Party, such Party conducting the studies shall provide the other Party with a copy of written study reports and access to data underlying any such study report, for use consistent with Articles 4 and 5.

Records, Reports and Information. Each Party shall maintain complete, current and accurate records of all work conducted by it under the Global Product each Development Plan, and all data and other Information Data resulting from such work. Such records shall fully and properly reflect all work done and results achieved in the performance of the such Development activities Plan in good scientific manner appropriate for regulatory and patent purposes. Each Party shall document all preclinical studies, non-clinical studies and clinical trials Clinical Studies in formal written study reports according to applicable national and international guidelines (e.g., ICH, GCP, GLP, GLP and GMP) guidelines). Each Party shall have the right to review such records maintained by the other Party at reasonable times, upon written request, which shall not exceed [***]once a year unless such request for review is required by (a) Applicable Laws or (b) its voluntary CAPA initiative. During the Term, on a regular basis, each Each Party shall present reports in English at the JSC meetings on its Joint Development activitiesand regulatory activities with respect to the Products, including without limitation any significant formal or informal meetings between such Party and the applicable Regulatory AuthoritiesAuthorities in its respective Territory, at a level of detail to be agreed upon by the JSC; provided, however, that any such presentation shall include at least a summary of the resulting data Data for all preclinical studies, non-clinical studies and all Clinical Studies conducted by a such Party with the Licensed Product under Product, subject to Forty Seven’s obligations to its licensees and the Global Product Development Plan, and provided further, upon request from the other Party, such Party conducting the studies shall provide the other Party with a copy of written study reports and access to data underlying any such study report, for use consistent with Articles 4 and 5.Upstream Agreements. Confidential ARTICLE V REGULATORY MATTERS