Manufacturing Development Expenses definition

Manufacturing Development Expenses means any costs incurred by a Party to a Third Party after the Effective Date for the Manufacturing Development.
Sample 1Sample 2Sample 3
Manufacturing Development Expenses means, with respect to the Development of a Product, the reasonable internal and external costs of a Party incurred in process development, process validation, process improvement, formulation development, manufacturing scale-up and recovery costs, the development of standard operating procedures, batch records, and quality assurance and quality control methods and procedures, and the production of qualification lots, all costs incurred in obtaining and maintaining approval specifically for the manufacture of such Product for commercial sale, and the costs for preparing, submitting, reviewing or developing data or information for the purpose of a drug master file or for submission to a Regulatory Authority to obtain or retain such approvals. A Party’s Manufacturing Development Expenses shall be determined in accordance with generally accepted accounting principles of the United States as consistently applied by such Party in the ordinary course of its business.
Sample 1Sample 2Sample 3
Manufacturing Development Expenses means, with respect to the Development of a Product, the reasonable internal and external costs of a Party incurred in process development, process validation, process improvement, formulation development, manufacturing scale-up and recovery costs, the development of standard operating procedures, batch records, and quality assurance and quality control methods and procedures, and the production of qualification lots, all costs incurred in obtaining and maintaining approval specifically for the manufacture of such Product for commercial sale, and the costs for preparing, submitting, reviewing or developing data or information for the purpose of a drug master file or for submission to a Regulatory Authority to obtain or retain such approvals. A Party's Manufacturing Development Expenses shall be determined in accordance with generally accepted accounting principles of the United States as consistently applied by such Party in the ordinary course of its business.
Sample 1Sample 2Sample 3

Examples of Manufacturing Development Expenses in a sentence

  • Manufacturing Development Expenses are included in Development Expenses and, as a result, shall be shared pursuant to Section 3.4 to the extent that such Manufacturing Development Expenses relate to the Manufacturing Development for Bulk API and/or Product to be Developed and Commercialized hereunder.


More Definitions of Manufacturing Development Expenses

Manufacturing Development Expenses means, with respect to the Development of a Product, the reasonable internal and external costs of a Party incurred in process development, process validation, process improvement, formulation
Sample 1
Manufacturing Development Expenses has the meaning set forth in Schedule A.
Sample 1
Manufacturing Development Expenses means, with respect to the Development of a Product as set forth in the applicable Manufacturing Plan, the reasonable internal costs of XOMA and the actual costs billed to XOMA or the Collaboration by Third Parties, each in accordance with the budget set forth in the applicable Manufacturing Plan, incurred in process development, process validation, process improvement, formulation development, manufacturing scale-up and recovery costs, the development of standard operating procedures, batch records, and quality assurance and quality control methods and procedures, and the production of qualification lots, all costs incurred in obtaining and maintaining approval specifically for the manufacture of such Product for commercial sale, and the costs for preparing, submitting, reviewing or developing data or information for the purpose of a drug master file or for submission to a Regulatory Authority to obtain or retain such approvals.
Sample 1
Manufacturing Development Expenses means, with respect to an Ophthalmic Product, to the extent not included in Development Expenses or Cost of Goods Sold, the [**]. Manufacturing Development Expenses shall be determined by a Party in accordance with generally accepted accounting principles in the United States consistently applied by such Party.
Sample 1
Manufacturing Development Expenses means, with respect to a Profit-Sharing Product, to the extent not included in Development Expenses or Cost of Goods Sold, the internal and external costs of a Party incurred in process development, process validation, process improvement, formulation development, product characterization, manufacturing scale-up and recovery costs, the development of SOPs and QA/QC methods and procedures, the production of qualification lots, all costs incurred in obtaining and maintaining approval for the Manufacture of such Profit-Sharing Product for commercial sale, and the costs of preparing, submitting, reviewing and developing data and information for the purpose of a drug master file or for submission to a Regulatory Authority to obtain or retain such approvals. Manufacturing Development Expenses shall be determined by a Party in accordance with generally accepted accounting principles in the United States consistently applied by such Party.
Sample 1

Related to Manufacturing Development Expenses

  • 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 Costs means the costs of Processing that generate Manufacturing Proceeds received by Grantor.

  • 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:

  • 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:

  • Manufacturing operation means a process in which materials are changed, converted, or transformed into a different state or form from which they previously existed and includes refining materials, assembling parts, and preparing raw materials and parts by mixing, measuring, blending, or otherwise committing such materials or parts to the manufacturing process. "Manufacturing operation" does not include packaging.

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

  • Manufacturing Cost means [***].

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

  • Marketing Costs which means such reasonable charge for marketing of ores and concentrates sold or of concentrates tolled as is consistent with generally accepted industry marketing practices;

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

  • Commercial Development Plan means the written commercialization plan attached as Appendix E.

  • Annual Work Plan and Budget means the work plan and budget approved by the Bank and adopted by the Borrower in accordance with the provisions of Section I.C of Schedule 2 of this Agreement, as said work plan and budget may be modified from time to time with the written agreement of the Bank.

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

  • 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;

  • Fully Burdened Manufacturing Cost means, with respect to any Licensed Product supplied by or on behalf of NVCR to Zai hereunder if such Licensed Product (or any precursor or intermediate thereof) is manufactured by a Third Party manufacturer [***].

  • Program Costs means all necessary and incidental costs of providing program services.

  • Development Program means the implementation of the development plan.

  • Research Budget has the meaning set forth in Section 3.2.

  • Development Activity means any activity defined as Development which will necessitate a Floodplain Development Permit. This includes buildings, structures, and non-structural items, including (but not limited to) fill, bulkheads, piers, pools, docks, landings, ramps, and erosion control/stabilization measures.

  • Initial Development Plan has the meaning set forth in Section 3.2(b).

  • medium term expenditure framework ’ means a budgeting framework applied by the National Treasury which—

  • Development Works means the external development works and internal development works on immovable property;

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Development Budget shall have the meaning set forth in Section 3.3.

  • 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.

  • Development Phase means the period before a vehicle type is type approved.