Process Development. The Development Plan/Budget for the first two (2) Contract Years shall include activities to optimize the current Manufacturing process and undertake analytical method development activities for ACE-536. Such optimization shall include scaling up the titer (which currently is at [* * *]) to a target of [* * *]. At Acceleron’s election, Acceleron may utilize the services of a Third Party, reasonably acceptable to Celgene, to conduct such optimization and analytical method development activities, and the costs of such Third Party, as approved as part of the Development Plan/Budget, shall be shared in accordance with Section 5.5.1. During this process, Acceleron shall share with Celgene information regarding the optimization and analytical methods development and consult with Celgene in connection therewith.
Process Development. In cases where no process exists or has been established, the College and Faculty Association will collaboratively establish a timeline for the creation of a process. Association or individual input and advice that do not meet the required timelines will be considered waivers of the right to provide input.
Process Development. The Parties will use commercially reasonable and diligent efforts to develop a process for the manufacture of each Collaboration Product and to scale up that process to a scale sufficient to manufacture and supply (a) the anticipated demand for preclinical studies and clinical trials of such Collaboration Product in accordance with the projections set forth in the Development Plan and (b) the anticipated market demand for such Collaboration Product at the time Regulatory Approval is obtained for such Collaboration Product in accordance with the projections set forth in the Commercialization Plan for such Collaboration Product. The development of the process for the manufacture of Collaboration Products as well as the scale up of such process and all material issues incident to the development of the ability to produce Collaboration Products for commercial purposes in sufficient quantity and in a timely manner will be within the purview of the Program Management Team. The Parties will use commercially reasonable and diligent efforts, and will cause any approved Third Party supplier, to make filings necessary to obtain approval of any license application for a manufacturing facility which may be required as part of any Regulatory Approval for the first Collaboration Product.
Process Development. Medica shall use [* * *] efforts to develop technical know-how that would permit them to manufacture the Cartridge less expensively and shall no less than semiannually furnish the Joint Review Committee with a detailed report as to their progress in this area. Vapotherm and Medica shall at the time of each report determine jointly the actions to be taken with respect to these findings.
Process Development. BioGenerics shall be responsible for any and all Process Development reasonably necessary for Licensee, its Affiliates and Sublicensees to Manufacture, Develop, or Commercialize the Products or to support Regulatory Approval in the Territory;
Process Development. LONZA shall perform activities in accordance with the terms and conditions of this Agreement, including applicable Statements of Work, to develop a process for the manufacture of each Product in conformance with the Specifications therefor, and in accordance with cGMP and other Applicable Laws as are standard in the biopharmaceutical manufacturing industry (each, a “Process”), including formulation development, establishment and maintenance of master cell banks, records preparation and process validation for such Product (including master production records and preparation and update of CMC or equivalent materials for applicable filings with Regulatory Authorities in Relevant Jurisdictions related to such Product), analytical method development and validation, manufacturing process (including applicable fill and finish) development and validation, production of applicable scale-up and engineering batches, and development of improved manufacturing processes to increase yield or otherwise lower costs and improve efficiency. LONZA shall provide quarterly updates to the JSC describing in reasonable detail its activities, progress and results in the process development program, including proposals or suggestions that LONZA may have to improve the manufacturing process efficiencies or otherwise reduce the cost of MPC Products.
Process Development. Each Party shall be responsible, at its expense, for manufacturing process development in accordance with the applicable Development Plan. The Development Plan for each HemOnc Product shall set forth the timeline and the Parties’ respective activities for the development of the manufacturing process for each such HemOnc Product, to be generally assigned to each Party consistent with the table below for each such HemOnc Product. In addition, manufacturing process development activities shall include technology transfer to Third Party manufacturers or Third Party research organizations for scale up and production of materials for clinical trials, and all other such activities related to development and validation of a commercial manufacturing process. Further, the Development Plan for each HemOnc Product shall set forth the criteria with respect to the manufacturing process for such HemOnc Product that must be satisfied prior to the transfer of such manufacturing process pursuant to Section 4.7(b) (with respect to such HemOnc Product, the “Manufacturing Process Transfer Criteria”). Each Party shall provide periodic written reports on its Development of the applicable manufacturing process. [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Process Development. The Parties will use, and shall cause their respective Permitted Subcontractors to use, commercially reasonable and diligent efforts to develop a process for the manufacture of each Collaboration Product and to scale up that process to a scale sufficient to manufacture and supply (a) the anticipated demand for preclinical studies and clinical trials of such Collaboration Product in accordance with the projections set forth in the Development Plan and (b) the anticipated market demand (plus a reasonable level of inventory) for such Collaboration Product at the time Regulatory Approval is obtained for such Collaboration Product in accordance with the projections set forth in the Commercialization Plan for such Collaboration Product. The development of the process for the manufacture of Collaboration Products as well as the scale up of such process and all material issues incident to the development of the ability to produce Collaboration Products for commercial purposes in sufficient quantity and in a timely manner will be within the purview of the Program Management Team, and all changes to the manufacturing process shall be subject to the approval of the Program Management Team and any additional quality and regulatory personnel of the Parties whose approval is deemed necessary or desirable.
Process Development. The current synthesis route for ER-306323 is a complex, [*]. Several alternate routes are currently being evaluated, with selection of a new route required in [*]. Delivery of the first GMP drug lot is targeted for [*]. To support early preclinical efficacy pharmacology and safety studies, an initial drug lot, prepared using the current synthetic route, has been initiated.
Process Development. (i) Summary report (raw data and original report) describing the development history until today.
(ii) The history of process scheme and report (raw data and original report) of the all reaction conditions tested.
(iii) The development report (raw data and original report) for the managing method of impurities in the drug substance.
(iv) Scale up development report (raw data and original report) including every manufacturing site.
