Common use of Information Regarding Development Activities Clause in Contracts

Information Regarding Development Activities. Each Party shall maintain, or cause to be maintained, records of Development work for which it is the Responsible Party under each Development Plan, in sufficient detail and in good scientific manner as appropriate for patent, regulatory and/or scientific purposes, which records shall fully and properly reflect all work done and results achieved by or on behalf of such Party in the performance of Development work for which it is the Responsible Party under each Development Plan. Each Party shall retain such records for at least * after the term of this Agreement, or for such longer period as may be required by Applicable Laws. Each Party shall keep the other Party appropriately informed, through the JDC or otherwise, of the status and results of the Development work for which it is the Responsible Party under each Development Plan, including by providing on a monthly basis (or more frequently as reasonably requested by the other Party) a written technical progress report describing, in sufficient detail to enable the other Party to review and assess, on a fully informed basis, the Responsible Party’s progress in performing the Development Plan activities for which it is responsible, the following: (i) Development activities conducted by or on behalf of the Responsible Party, including any such activities performed by a permitted subcontractor; (ii) the progress achieved in implementing and executing each Development Plan, including providing deliverables and achieving milestones (if any) set forth in each Development Plan; (iii) Know-How developed or created in the course of performing Development; (iv) any difficulties and unexpected circumstances encountered, as well as variations, if any, from the schedule set forth in the Development Plan; and (v) any other relevant matters. Upon reasonable request by the other Party, without limiting the foregoing, the Responsible Party shall provide the other Party with summaries of data and results and other Know-How resulting from Development work for which it is the Responsible Party under a Development Plan and, if requested by the other Party, shall provide access to all data and results and other Know-How in the possession or under the control of the Responsible Party that are generated or obtained by such Responsible Party or its permitted subcontractors in the course of performance of Development work. Upon reasonable prior written notice, the other Party shall have the right to inspect and copy any such records and notebooks in the possession or under the control of the Responsible Party reflecting the work done and results achieved under a Development Plan by the Responsible Party or any permitted subcontractor.

Appears in 2 contracts

Samples: Development and Collaboration Agreement (Acucela Inc), Development and Collaboration Agreement (Acucela Inc)

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Information Regarding Development Activities. Each Party shall maintain, or cause to be maintained, records of Development work for which it is the Responsible Party under each Development Plan, in sufficient detail and in good scientific manner as appropriate for patent, regulatory and/or scientific purposes, which records shall fully and properly reflect all work done and results achieved by or on behalf of such Party in the performance of Development work for which it is the Responsible Party under each Development Plan. Each Party shall retain such records for at least * after the term of this Agreement, or for such longer period as may be required by Applicable Laws. Each Party shall keep the other Party appropriately informed, through the JDC or otherwise, of the status and results of the Development work for which it is the Responsible Party under each Development Plan, including by providing on a monthly basis (or more frequently as reasonably requested by the other Party) a written technical progress report describing, in sufficient detail to enable the other Party to review and assess, on a fully informed basis, the Responsible Party’s progress in performing the Development Plan activities for which it is responsible, the following: (i) Development activities conducted by or on behalf of the Responsible Party, including any such activities performed by a permitted subcontractor; (ii) the progress achieved in implementing and executing each Development Plan, including providing deliverables and achieving milestones (if * Confidential Treatment Requested. any) set forth in each Development Plan; (iii) Know-How developed or created in the course of performing Development; (iv) any difficulties and unexpected circumstances encountered, as well as variations, if any, from the schedule set forth in the Development Plan; and (v) any other relevant matters. Upon reasonable request by the other Party, without limiting the foregoing, the Responsible Party shall provide the other Party with summaries of data and results and other Know-How resulting from Development work for which it is the Responsible Party under a Development Plan and, if requested by the other Party, shall provide access to all data and results and other Know-How in the possession or under the control of the Responsible Party that are generated or obtained by such Responsible Party or its permitted subcontractors in the course of performance of Development work. Upon reasonable prior written notice, the other Party shall have the right to inspect and copy any such records and notebooks in the possession or under the control of the Responsible Party reflecting the work done and results achieved under a Development Plan by the Responsible Party or any permitted subcontractor.

Appears in 1 contract

Samples: Development and Collaboration Agreement

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Information Regarding Development Activities. Each Party shall maintain, or cause to be maintained, records of Development the clinical trials and other development work for which it is the Responsible Party under each Development PlanParty, in sufficient detail and in good scientific manner as appropriate for patent, patent and regulatory and/or scientific purposes, which records shall fully and properly reflect all work done and results achieved by or on behalf of such Party in the performance of such clinical trials and other development work under the Development work for which it is the Responsible Party under each Development PlanPlans. Each Party shall retain such records for at least * five years after the term of this AgreementTerm, or for such longer period as may be required by Applicable Laws. Each Party Party, through the JDC, shall keep the other Party appropriately informed, through the JDC or otherwise, informed of the status and results of the Development clinical trials and other development work with respect to each Product for which it is the Responsible Party under each any Development Plan, including by providing on a monthly basis (or more frequently as reasonably requested by the other Party) a written technical progress report describing, in sufficient detail to enable the other Party to review and assess, on a fully informed basis, the Responsible Party’s progress in performing the Development Plan activities for which it is responsible, the following: (i) Development activities conducted by or on behalf of the Responsible Party, including any such activities performed by a permitted subcontractor; (ii) the progress achieved in implementing and executing each Development Plan, including providing deliverables and achieving milestones (if any) set forth in each Development Plan; (iii) Know-How developed or created in the course of performing Development; (iv) any difficulties and unexpected circumstances encountered, as well as variations, if any, from the schedule set forth in the Development Plan; and (v) any other relevant matters. Upon reasonable request by the other a Party, without limiting the foregoing, the Responsible other Party shall provide the other Party requesting Party, according to a reasonable time frame, with summaries of data and results and other Program Know-How resulting from Development such clinical trials or other development work for which it is the Responsible Party under a Development Plan and, if requested by the other requesting Party, shall provide access to all supporting data and results and other Program Know-How in the possession or under the control of the Responsible Party that are generated or obtained by such Responsible Party or its permitted subcontractors in the course of such other Party’s performance of the clinical trials or other development work for which such other Party is the Responsible Party under any Development workPlan. Upon reasonable prior written notice, the other each Party shall have the right to inspect and copy any such records and notebooks in the possession or under the control of the Responsible Party reflecting the work done and results achieved under a Development Plan by or on behalf of the Responsible other Party or any permitted subcontractorits Affiliates in the performance of such other Party’s clinical trials and other development work with respect to Compounds, Related Compounds or Products. For clarity, Eisai shall provide to Arena, and Arena shall have access to and be able to use (and transfer to its Affiliates and Arena ex-Territory Partners) all data and results of all Eisai development activities, for use in developing, registering and obtaining regulatory approvals of and commercializing Products outside the Territory.

Appears in 1 contract

Samples: Marketing and Supply Agreement (Arena Pharmaceuticals Inc)

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