Process Specifications. With respect to each Process Supplement, Company shall deliver the technical specifications listed and described in the Process Supplement in accordance with the time schedule provided in such Process Supplement. Without limiting the foregoing, both Company and Foundry will contribute necessary technical resources and manpower for successfully establishing the Company Process at TSMC within the schedule set forth in such Process Supplement. The Parties agree to use commercially reasonable efforts to achieve the milestones or execute statements of work that may be identified in Process Supplements or as otherwise mutually agreed. Should there be any delay or delinquency, the Parties agree to negotiate, in good faith, for a commercially reasonable solution.
Process Specifications. With respect to each Process Supplement, Spansion shall deliver the specifications listed and described in the Process Supplement in accordance with the time schedule provided in such Process Supplement. Without limiting the foregoing, SMIC will contribute necessary technical resources and manpower for successfully establishing the Spansion Process at SMIC within the schedule set forth in such Process Supplement. SMIC agrees to use its best efforts to achieve the milestones or execute statements of work that may be identified in Process Supplements or as otherwise mutually agreed. If SMIC fails to meet the scheduled dates or milestones in a Process Supplement, SMIC shall provide Spansion with a recovery plan to meet future scheduled dates or milestones.
Process Specifications. The design of the Plant and Materials that forms part of the design for the works is required to conform to the following requirements:
Process Specifications. Following the Effective Date, LBIO shall provide the Process Specifications to Company and such Background Intellectual Property of LBIO as may be reasonably required by Company to perform the Services hereunder pursuant to a Statement of Work. For clarity, all right and title to and in such Process Specifications and LBIO’s Background Intellectual Property shall remain solely vested in LBIO.
Process Specifications. The Manufacturing process for the Product complies with current specifications on the Effective Date, and has been successfully validated in accordance with GMP (if applicable), and finally approved by Valneva. Valneva and Xxxxxx shall agree in writing to the final Process Specifications for performance of any Services under this Agreement, and written documentation of such Process Specifications shall be attached to or referenced in the Quality Agreement and incorporated therein by reference. Valneva shall ensure that the Process Specifications comply with the Regulatory Approvals, Regulatory Filings and any applicable Legal Requirements. If the Valneva requires Xxxxxx to adhere to any additional good manufacturing practices of countries outside the Territory or any requirements coming from Valneva Legal Requirements, Regulatory Approvals, Regulatory Filings or any Product-specific GMP (either thereof “Additional Requirements”), any such Additional Requirements may be, after Xxxxxx review and by mutual prior written agreement of the Parties (including on regulatory, technical, commercial, quality and/or certain other provisions and documents applicable to such Products) be incorporated into the agreed Process Specifications. Valneva shall provide Xxxxxx Pharma with, included in any such request of Additional Requirements, the country-specific legislation, rules and regulations and practices or requirements of the regulatory authorities and governmental bodies, which may affect the Services (including the set-up, content and use of the CTD), the Manufacture and/or any Assistance, and shall inform Xxxxxx of the effect of any thereof. Valneva shall keep Xxxxxx informed of any changes of any thereof after the Effective Date and shall meet all notice and information requirements as set forth in the Quality Agreement. Valneva shall also provide Xxxxxx with all information reasonably necessary for the performance of the Services and any technical support reasonably requested by Xxxxxx in connection with the same. Xxxxxx shall keep Valneva informed of Xxxxxx’x positive knowledge, if any, of any specific legislation, rules and regulations and practices or requirements of the generally applicable regulatory requirements of German authorities, EMA and FDA, which may affect the set-up, content and use of the CTD, and shall inform Valneva of the effect thereof known to Xxxxxx.
Process Specifications. From time to time, Iovance shall provide the Process Specifications to Company and such Background Intellectual Property of Iovance as may be reasonably required by Company to perform the Services hereunder pursuant to a Statement of Work. For clarity, all right and title to and in such Process Specifications and Iovance’s Background Intellectual Property shall remain solely vested in Iovance.
Process Specifications
