Manufacturing Transition Costs definition

Manufacturing Transition Costs means the Direct Costs associated with the transfer by Jounce, following the Jounce Lead Effective Date, of responsibility for Manufacturing and CMC Activities to Celgene or a Third Party, [***].
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Manufacturing Transition Costs means the Direct Costs associated with the transfer by Vividion, following the Effective Date, of responsibility for Manufacturing and CMC activities to Celgene or a Third Party selected by Celgene, including [***].
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Manufacturing Transition Costs means [***].
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Examples of Manufacturing Transition Costs in a sentence

  • All Manufacturing Costs associated with Manufacturing Shared Products (including Manufacturing Transition Costs) shall be shared by the Parties in accordance with the Profit & Loss Share.

  • For clarity, any costs associated with Manufacturing (and CMC Activities) that are not Manufacturing Transition Costs, including any costs associated with the transition of CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”.

  • For clarity, any costs associated with Manufacturing (and CMC Activities) that are not Manufacturing Transition Costs, including any costs associated with the transition of Manufacturing activities from one Manufacturing site to another Manufacturing site, will be included in the calculation of Worldwide Development Costs.

  • All Manufacturing Costs associated with Manufacturing Shared Products and Companion Diagnostics (including Manufacturing Transition Costs) for U.S. Administration, excluding Manufacture of Shared Products and Companion Diagnostics for sale for U.S. Administration that are included as “Cost of Goods Sold” in the Profit & Loss Share, will be included in the calculation of Worldwide Development Costs, and shared by the Parties in accordance with the Development Cost Share.

  • Any costs associated with Manufacturing (including Manufacturing Transition Costs), excluding Manufacture of Co-Co Products and Co-Co Diagnostic Products for sale for which such costs are included as “Cost of Goods Sold” in the Profit & Loss Share, will be included in the calculation of Worldwide Development Costs, and shared by the Parties in accordance with the Development Cost Share.

  • For the avoidance of doubt, Manufacturing Transition Costs include only those costs associated with enabling transition of capabilities to GE and do not include expenses by or on behalf of GE in connection with ongoing business operations, even if concurrent with any transition period.

  • Any costs associated with Manufacturing (including Manufacturing Transition Costs), excluding Manufacture of Co-Co Products and Co-Co Diagnostic Products for sale for which such costs are included as “cost of goods sold” in the Profit & Loss Share, will be included in the calculation of Worldwide Development Costs, and shared by the Parties in accordance with the Development Cost Share.

  • For clarity, any costs associated with Manufacturing (and CMC Activities) that are not Manufacturing Transition Costs, including [***], will be solely borne by Celgene.

  • With respect to Co-Co Products, [***] shall be responsible for all Manufacturing Transition Costs.

  • With respect to Licensed Products, [***] shall be responsible for all Manufacturing Transition Costs.


More Definitions of Manufacturing Transition Costs

Manufacturing Transition Costs means the direct out-of-pocket costs associated with the transfer by Forma Inc., following the Effective Date, of responsibility for manufacturing activities to Celgene, including costs associated with both the transfer of technology relating to the manufacture of Licensed Compounds and Licensed Products and technical assistance provided by Forma Inc. in relation to such transfer.
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Manufacturing Transition Costs has the meaning set forth in Section 17.03(b).
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Manufacturing Transition Costs means the Direct Costs associated with the transfer by BioAtla of responsibility for Manufacturing and CMC activities to BeiGene or a Third Party selected by BeiGene, including Direct Costs associated with the transfer of all Manufacturing Technology and the providing of technical assistance by BioAtla in relation to such transfer.
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Manufacturing Transition Costs means the [***] costs associated with the transfer by OncoMed, following the Co-Co Agreement Effective Date, of responsibility for Manufacturing and CMC Activities to Celgene or a Third Party, including [***], and [***] in relation to such transfer. Manufacturing Transition Costs shall not include [***].
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Related to Manufacturing Transition Costs

  • Commercialization Costs means the sum of the following costs and expenses incurred by the Parties or their respective Affiliates, in Commercializing the Shared Products (and related Manufacturing activities) in the Territory, in each case, to the extent incurred in accordance with the Commercialization Plan and Commercialization Budget:

  • Transition Costs means the reasonable costs and expenses (including reasonable attorneys’ fees but excluding overhead) incurred or payable by the Successor Servicer in connection with the transfer of servicing (whether due to termination, resignation or otherwise), including allowable compensation of employees and overhead costs incurred or payable in connection with the transfer of the Receivable Files or any amendment to the Sale and Servicing Agreement required in connection with the transfer of servicing.

  • Manufacturing Costs means [***].

  • Basic generation service transition costs means the amount by

  • Manufacturing Site means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 8.7.

  • Manufacturing Facilities means facilities engaged in the mechanical or chemical transformation of materials or substances into new products and shall include:

  • Clinical Supply Agreement shall have the meaning set forth in Section 7.2.

  • Manufacturing Facility means buildings and structures, including machinery and equipment, the primary purpose of which is or will be the manufacture of tangible goods or materials or the processing of such goods or materials by physical or chemical change.

  • Manufacturing Services means the manufacturing, quality control, quality assurance, stability testing, packaging, and related services, set forth in this Agreement, required to manufacture Product or Products from Active Materials and Components;

  • Manufacturing Know-How means, with respect to the Product or any Variant thereof, the technology, data, designs, processes, methods, specifications and other know-how used in connection with the formulation, manufacture, labeling, packaging, quality control, release testing, and production of the Product, and all ingredients used therein and portions thereof.

  • Manufacturing Process means any process for—

  • Manufacturing Agreement has the meaning set forth in Section 2.6.

  • Manufacturing Cost means [***].

  • Development Expenses means, with respect to SAIL Developments as well as HOME Developments when the HOME Development is also at least partially financed with a MMRB Loan (as defined in rule Chapter 67-21, F.A.C.), usual and customary operating and financial costs, such as the compliance monitoring fee, the financial monitoring fee, replacement reserves, the servicing fee and the debt service reserves. As it relates to SAIL Developments as well as HOME Developments when the HOME Development is also at least partially financed with a MMRB Loan (as defined in rule Chapter 67-21, F.A.C.) and to the application of Development Cash Flow described in subsections 67-48.010(5) and (6), F.A.C., as it relates to SAIL Developments or in paragraph 67-48.020(3)(b), F.A.C., as it relates to HOME Developments, the term includes only those expenses disclosed in the operating pro forma on an annual basis included in the final credit underwriting report, as approved by the Board, and maximum of 20 percent Developer Fee per year.

  • Manufacturing Technology means any and all patents, patent applications, Know-How, and all intellectual property rights associated therewith, and including all tangible embodiments thereof, that are necessary or useful for the manufacture of adeno- associated viruses, adeno-associated virus vectors, research or commercial reagents related thereto, Licensed Products, or other products, including manufacturing processes, technical information relating to the methods of manufacture, protocols, standard operating procedures, batch records, assays, formulations, quality control data, specifications, scale up, any and all improvements, modifications, and changes thereto, and any and all activities associated with such manufacture. Any and all chemistry, manufacturing, and controls (CMC), drug master files (DMFs), or similar materials provided to regulatory authorities and the information contained therein are deemed Manufacturing Technology.

  • Development Activities means those activities which are normally undertaken for the development, construction, rehabilitation or conversion of buildings for residential purposes, including the acquisition of property;

  • Development Costs means costs incurred to obtain access to reserves and to provide facilities for extracting, treating, gathering and storing the oil and gas from reserves. More specifically, development costs, including applicable operating costs of support equipment and facilities and other costs of development activities, are costs incurred to:

  • Development Plan has the meaning set forth in Section 3.2.

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • Production Costs means those costs and expenditures incurred in carrying out Production Operations as classified and defined in Section 2 of the Accounting Procedure and allowed to be recovered in terms of Section 3 thereof.

  • Development Plans has the meaning set forth in Section 3.2.