Example ContractsClausesDevelopment Records
Development Records
Development Records contract clause examples

Each Party shall maintain records of its activities under the Global Development Plan and for Clinical Studies, Post-Approval Commitment Studies and Phase IV Studies of Product conducted pursuant to this Agreement outside the Global Development Plan (or cause such records to be maintained) in sufficient detail and in good scientific manner as will properly reflect all work done and results achieved by or on behalf of such Party in the performance of the development.

Development Records. Ji Xing shall maintain complete, current and accurate records of all Development activities conducted by or on behalf of Ji Xing hereunder, and all data and other information resulting from such activities. 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. Ji Xing shall document all non-clinical studies and Clinical Trials in formal written study reports according to Applicable Laws and national and international guidelines (e.g., ICH, GCP, GLP, and cGMP). [[Cytokinetics:Organization]] shall have the right to review and copy such records maintained by Ji Xing at reasonable times and to use such records and obtain access to the original for its research and development activities and regulatory and patent purposes or for other legal proceedings.

Development Records. Each Party shall maintain complete, current and accurate records of all Development activities conducted by it hereunder, and all data and other information resulting from such activities. Such records shall fully and properly reflect all work done and results achieved in the performance of the Development activities in good scientific manner [ * ]. Each Party shall document all non-clinical studies and clinical trials in formal written study reports according to applicable Laws and national and international guidelines (e.g., ICH, GCP, GLP, and GMP). Each Party shall have the right to review and copy such records maintained by the other Party at reasonable times and to obtain access to the original [ * ].

Development Records. Each Party shall, and shall require its Affiliates and its and their sublicensees and Third Party subcontractors to, maintain, in good scientific manner, complete and accurate books and records pertaining to Development of Licensed Products for use in the Licensed Field (“Development Records”), in sufficient detail to verify compliance with its obligations under this Agreement. Such books and records shall # be appropriate for patent and regulatory purposes, # be in compliance with Applicable Law, # properly reflect all work done and results achieved in the performance of its Development activities hereunder, # record only such activities and not include or be commingled with records of activities outside the scope of this Agreement and # be retained, with respect to Development Records of a Party, by such Party for at least ​ after the expiration or termination of this Agreement in its entirety or for such longer period as may be required by Applicable Law. Each Party shall have the right, during normal business hours and upon reasonable notice, to inspect and copy all Development Records of a Party maintained pursuant to this Section 3.4.1 for the purpose of confirming compliance with this Agreement and fulfilling its obligations under this Agreement; provided that such Party shall maintain such records and information disclosed therein in confidence in accordance with ARTICLE 10 ​. Without limiting the foregoing, each Party shall maintain such Development Records as is necessary to comply with each of the applicable provisions in this Agreement.

Development Records. [[3D Medicines:Organization]] shall maintain complete, current and accurate records of all activities (and all Data and other Information resulting from such activities) conducted with respect to Licensed Products by [[3D Medicines:Organization]], its Affiliates and their respective Sublicensees in the [[3D Medicines:Organization]] Territory. 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. [[3D Medicines:Organization]] shall document all non-clinical studies and Clinical Trials for Licensed Products in formal written study records according to applicable Laws, including applicable national and international guidelines such as ICH, GCP and GLP, and shall provide [[Aravive:Organization]] English translations thereof (to the extent prepared and originated in a language other than English). [[Aravive:Organization]] shall have the right to review and copy such records at reasonable times and to obtain access to the original to the extent necessary or useful for regulatory or patent purposes in accordance with this Agreement.

Development Records. Licensee shall, and shall cause its Affiliates and its and their Sublicensees to, maintain, in good scientific manner, complete and accurate books and records pertaining to Development of Licensed Product hereunder, in sufficient detail to verify compliance with its obligations under this Agreement. Such books and records shall # be appropriate for patent and regulatory purposes, # be in compliance with Applicable Law, # properly reflect all work done and results achieved in the performance of its Development activities hereunder, and # be retained by Licensee for at least ​ after the expiration or termination of this Agreement in its entirety or for such longer period as may be required by Applicable Law. ​.

Development Records. Acadia shall maintain complete, current and accurate records of the Development activities it conducts under a Development Program in good scientific manner appropriate for regulatory and patent purposes. Acadia shall document all non-clinical studies and Clinical Trials in formal written study reports according to Applicable Laws and national and international guidelines (e.g., ICH, GCP, GLP, and GMP).

Development Records. Ji Xing shall maintain complete, current and accurate records of all Development activities conducted by or on behalf of Ji Xing hereunder, and all data and other information resulting from such activities. 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. Ji Xing shall document all non-clinical studies and Clinical Trials in formal written study reports according to Applicable Laws and national and international guidelines (e.g., ICH, GCP, GLP, and cGMP). [[Cytokinetics:Organization]] shall have the right to review and copy such records maintained by Ji Xing at reasonable times and to use such records and obtain access to the original for its research and development activities and regulatory and patent purposes or for other legal proceedings.

Development Records. Bausch Health shall maintain complete, current and accurate records in either tangible or electronic form of # all Development activities conducted by or on behalf of Bausch Health, its Affiliates and Sublicensees related to Products; and # all material information generated by or on behalf of Bausch Health, its Affiliates and Sublicensees in connection with Development of Products. Bausch Health shall maintain such records in sufficient detail to properly reflect, in a good scientific manner, all significant Development work. Upon Clearside’s request, Bausch Health shall, and shall cause its Affiliates and Sublicensees to provide to Clearside copies of any such records to the extent relating to the XIPERE Products or the Device. ​.

Development Records. Apollomics shall maintain complete, current and accurate records of all activities conducted pursuant to the Development Plan by Apollomics, its Affiliates and their respective sublicensees, and all Data and other Information resulting from such activities. 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. Apollomics shall document all non-clinical studies and clinical trials in formal written study records in accordance with all Applicable Law, including applicable national and international guidelines such as ICH, GCP and GLP. [[GlycoMimetics:Organization]] shall have the right to review and copy such records at reasonable times and to obtain access to review the original to the extent necessary or useful for regulatory or patent purposes upon reasonable notice to Apollomics and at a time and location mutually acceptable to Apollomics. Notwithstanding anything to the contrary herein, Apollomics shall have the right to retain the originals of all its records.

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