Information Regarding Development Activities. Each Party shall maintain records, in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes, which shall fully and properly reflect all work done and results achieved by or on behalf of such Party in the performance of its development activities under this Agreement. Each Party shall keep the Joint Steering Committee appropriately informed of the status of the clinical development program and other activities with respect the Licensed Product in the Field conducted under the Development Plan and other development activities under or pursuant to Sections 4.2 and 4.3. Upon request by the Joint Steering Committee, without limiting the foregoing, each Party shall promptly provide the Joint Steering Committee with summaries of data and results and, if requested by the Joint Steering Committee, all supporting data and results generated or obtained in the course of such Party’s performance of studies and activities under the Development Plan. Upon reasonable prior written notice, each Party shall have the right to inspect records and notebooks reflecting the work done and results achieved by or on behalf of the other Party or its Affiliates in the performance of its development activities with respect to the Licensed Product in the Field pursuant to the Development Plan.
Information Regarding Development Activities. Each Party shall maintain records, in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes, which shall fully and properly reflect all work done and results achieved by or on behalf of such Party in the performance of its development activities under this Agreement. Each Party shall keep the Joint Steering Committee appropriately informed of the status of its clinical development program and other activities conducted under the Xxxxxx Xxxxxxx Development Plan, the Palatin Development Plan and the other provisions of this Agreement, as applicable, and its other development activities with respect to the Product in the Field. Without limiting the foregoing, each Party shall, on a *** basis (or, if sooner, promptly upon request by the Joint Steering Committee), provide the Joint Steering Committee with summaries of data and results and all supporting data and results generated or obtained in the course of such Party’s performance of studies and activities under the Xxxxxx Xxxxxxx Development Plan and the Palatin Development Plan, and the other provisions of this Agreement, as applicable. Each Party shares any Information with the other Party on request. Upon reasonable prior written notice, each Party shall have the right to inspect records and notebooks reflecting the work done and results achieved by or on behalf of the other Party in the performance of its development activities with respect to the Product in the Field pursuant to either the Xxxxxx Xxxxxxx Development Plan or the Palatin Development Plan and the other provisions of this Agreement, as applicable. The Parties may use information exchanged pursuant to this Section 4.3.3 for any purpose in connection with the Development and Commercialization of Products in the Field in the Territory (in the case of Xxxxxx Xxxxxxx) and outside the Field in the Territory and outside the Territory (in the case of Palatin).
Information Regarding Development Activities. Acucela shall maintain, or cause to be maintained, records of Development work in sufficient detail and in good scientific manner as appropriate for patent, regulatory and/or scientific purposes and to enable Otsuka to verify Acucela’s compliance with all of its obligations under each Development Plan and this Agreement, which records shall fully and properly reflect all work done and results achieved by or on behalf of Acucela in the performance of Development work under the Development Plans. Acucela shall retain such records for at least five (5) years after the term of this Agreement, or for such longer period as may be required by Applicable Laws. Acucela shall keep Otsuka appropriately informed, through the JDC or otherwise, of the status and results of the Development work, including by providing on a monthly basis (or more frequently as reasonably requested by Otsuka) a written technical progress report describing, in sufficient detail to enable Otsuka to review and assess, on a fully informed basis, Acucela’s progress in performing the Development Plan, the following: (i) Development activities conducted by or on behalf of Acucela, 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 Otsuka, without limiting the foregoing, Acucela shall provide Otsuka with summaries of data and results and other Know-How resulting from Development work and, if requested by Otsuka, shall provide access to all data and results and other Know-How in the possession or under the control of Acucela or any permitted subcontractor that are generated or obtained in the course of performance of Development work. Upon reasonable prior written notice, Otsuka shall have the right to inspect and copy any such records and notebooks reflecting the work done and results achieved under a Development Plan by Acucela or any permitted subcontractor.
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 reco...
Information Regarding Development Activities. Teva shall maintain records, in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes, which shall fully and properly reflect all work done and results achieved by or on behalf of Teva in the performance of its development activities under this Agreement. Teva shall, through the Development JPT, keep the JSC appropriately informed of the status of clinical and preclinical studies and other activities with respect to the Product conducted with respect to the U.S. Upon request by the JSC, without limiting the foregoing, Teva shall promptly provide the JSC with summaries of data and results and, if requested by the JSC, all supporting data and results generated or obtained in the course of Teva’s performance of studies and activities under its Development Plan.
Information Regarding Development Activities. Eisai shall maintain, or cause to be maintained, records of the clinical trials and other development work, in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes, which shall fully and properly reflect all work done and results achieved by or on behalf of Eisai in the performance of such clinical trials and other development work under this Agreement or the Existing Agreement. Eisai shall retain such records during the Term and for at least five years after the Term, or for such longer period as may be required by Applicable Laws.
Information Regarding Development Activities. Each Party shall maintain records, in sufficient detail and in good scientific manner appropriate for Patent and regulatory purposes, which shall fully and properly reflect all work done and results achieved by or on behalf of such Party in the performance of its Development activities under this Agreement. Each Party shall keep the JAC appropriately informed of the status of studies and other activities with respect to Product in the Field in the Territory conducted under the Development Plan. Upon request by the JAC, without limiting the foregoing, each Party shall promptly provide the JAC with summaries in reasonable detail of all Data and results generated or obtained in the course of such Party’s performance of studies and activities under the Development Plan.
Information Regarding Development Activities. Each Party shall maintain, or cause to be maintained, records of the clinical trials and other development work for which it is the Responsible Party, in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes, which 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 Plans. Each Party shall retain such records for at least five years after the Term, or for such longer period as may be required by Applicable Laws. Each Party shall keep the other Party appropriately informed of the status and results of the clinical trials and other development work with respect to each Product for which it is the Responsible Party under any Development Plan. Upon reasonable request by a Party, without limiting the foregoing, the other Party shall provide the requesting Party, according to a reasonable time frame, with summaries of data and results and other Program Know-How resulting from such clinical trials or other development work and, if requested by the requesting Party, shall provide access to all supporting data and results and other Program Know-How generated or obtained 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 Plan. Upon reasonable prior written notice, each Party shall have the right to inspect and copy any such records and notebooks reflecting the work done and results achieved under a Development Plan by or on behalf of the other Party or its 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.
Information Regarding Development Activities. Partner shall maintain records, in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes, which shall fully and properly reflect all work done and results achieved by or on behalf of Partner in the performance of Development activities pursuant to this Agreement. Partner shall keep the JSC appropriately informed of the status of clinical, pre-clinical and post-approval studies and other activities with respect to Compounds and Products in the Field in the Territory conducted by it pursuant to this Agreement. Upon request by the JSC, without limiting the foregoing, Partner shall promptly provide the JSC with summaries in reasonable detail of all data and results generated or obtained in the course of Partner’s and its Sublicensees’ performance of studies and other activities with respect to Compounds and Products in the Field in the Territory. Upon request by the JSC, without limiting the foregoing, Optimer shall provide the JSC with summaries in reasonable detail of all data and results that are generated or obtained in the course of Optimer’s and its licensees’ (other than XXXX’x and its sublicensees’) performance of studies and other Development activities with respect to Compounds and Products in the Field outside the Territory including full details and specifications of all Product formulations […***…], provided that in no event shall Optimer be required to disclose to Partner or the JSC any data or results of any licensee unless Optimer is permitted to do so under the applicable agreement with such licensee.
Information Regarding Development Activities. Each Party shall maintain, or cause to be maintained, records of all the clinical trials and other development work conducted by or on behalf of such Party hereunder on Product, in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes, which 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 Plans. Each Party shall retain such records for at least three (3) years after the Term, or for such longer period as may be required by Applicable Laws. Each Party shall keep the other Party appropriately informed of the status and results of the clinical trials and other development work with respect to Product under any Development Plan, including, if requested by the other Party, disclosing to such other Party all Development Data and other results of such development work. Roivant shall have the right to inspect and copy any such records and notebooks reflecting the work done and results achieved under a Development Plan by or on behalf of Arena in the performance of clinical trials and other development work with respect to Product under the Development Plans. It is understood and agreed that any and all research, development and Commercialization work conducted by or on behalf of Roivant, its Sub-distributors, Arena or their respective Affiliates, on Compound or Product in accordance with the Development Plan shall be deemed activities conducted under this Agreement. *** This portion has been redacted pursuant to a confidential treatment request under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.
