Manufacturing Expenses means, with respect to the Initial Product, the reasonable and necessary internal and Third Party invoiced costs, determined in accordance with GAAP and the terms and conditions of this Agreement, incurred in Manufacturing or acquisition of the Initial Product for sale in the Northern American Territory. Manufacturing costs and acquisition costs are comprised of Standard Cost of Goods Manufactured, Cost Variances and Other Costs Not Included in Standard, where:
Manufacturing Expenses means, with respect to the Licensed Compound or any Licensed Product, the aggregate of fully burdened (excluding accounting expenses) internal costs (including actual direct labor based on internal FTE Costs) and Third Party Expenses (without xxxx-up) incurred by a Party and its Affiliates to Manufacture such Licensed Compound or Licensed Product, calculated as follows, in each case determined in accordance with GAAP, as consistently applied by such Party and its Affiliates: (a) to the extent that such Party or its Affiliates performs all or any part of the Manufacturing of the Licensed Compound or Licensed Product, (i) the direct material costs (including media and purification reagents) and direct FTE Costs for such Manufacturing of the Licensed Compound or Licensed Product, which may include, to the extent actually incurred in such Manufacture, cleaning costs of productions, Manufacturing administrative (including overhead costs allocable to the Manufacturing, but excluding all corporate general and administrative overhead costs), the costs of audits, and all directly incurred Manufacturing variances; (ii) a [**] of the costs of [**] of Licensed Compound (calculated by [**]) (e.g., [**]); and (iii) Manufacturing facilities costs (including depreciation, repairs and maintenance costs), scale-up directly allocable to the Manufacture of the Licensed Compound or Licensed Product (including API and drug product production), quality assurance and quality control and technical support, provided that, for commercial supply, each of (i) and (iii) may be included in Manufacturing Expenses only to the extent such costs and expenses are inventoriable under GAAP as consistently applied by such Party or its Affiliates; provided that, all costs of direct labor shall be calculated based on the FTE Rate; and (b) to the extent that a Third Party performs all or any part of the Manufacturing of the Licensed Compound or Licensed Product, the reasonable out-of-pocket costs paid to such Third Party for such activities determined in accordance with GAAP. All invoices for Manufacturing Expenses submitted under this Agreement will include a detailed calculation and description of the relevant overhead allocations. For clarity, Manufacturing Expenses shall not include: (A) any [**]; (B) any costs, expenses or overhead associated [**] (e.g., if Manufacturing activities [**] Licensed Compound Bulk Drug Substance produced [**] ([**]) of the [**] of the plant if the plant were [**])...
Manufacturing Expenses means (a) with respect to Drug Substance or Drug Product that is Manufactured by a Third Party the actual purchase price paid by Takeda or its Affiliate to such Third Party for such Drug Substance or Drug Product, and (b) with respect to Drug Substance or Drug Product that is Manufactured directly by Takeda or its Affiliate the Direct Expenses and Indirect Expenses incurred in connection with the Manufacture of the Drug Substance or Drug Product, [***], such calculation being based upon accepted industry standards and the applicable Accounting Standard. Manufacturing Expenses shall not include any: [***]. [***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406.
Examples of Manufacturing Expenses in a sentence
Cost of Material Rs.1,60,000 ; Wages 2,40,000; Manufacturing Expenses Rs.1,00,000; Salaries Rs.1,20,000; Rent, Rates and Insurance Rs 20,000; Selling Expenses Rs.60,000; General expenses Rs. 40,000; and Sales Rs,8,00,000 The company plans to manufacture 3,000 sewing machines during 2016.
These deal the aspects of planning, process re-engineering and implementation.
For the avoidance of doubt, the first invoice submitted by Takeda pursuant to this Section 3.2 may include Manufacturing Expenses incurred by Takeda in furtherance of its Manufacture of additional Drug Substance or Drug Product that was not part of the Initial Clinical Supply.
In the event the Initial Clinical Supply is insufficient to conduct and complete the activities contemplated under the TAK-385 Development Plan, Myovant shall pay [***] of the actual Manufacturing Expenses incurred by Takeda in Manufacturing such additional Drug Substance and Drug Product.
For the avoidance of doubt, Myovant shall [***] Takeda for all Manufacturing Expenses incurred by Takeda related to the re-working or re-processing of any Drug Substance or Drug Product that was manufactured by Takeda prior to the Effective Date of this Agreement.
More Definitions of Manufacturing Expenses
Manufacturing Expenses means (a) with respect to Drug Substance or Drug Product that is Manufactured by a Third Party the actual purchase price paid by Takeda or its Affiliate to such Third Party for such Drug Substance or Drug Product, and (b) with respect to Drug Substance or Drug Product that is Manufactured directly by Takeda or its Affiliate the Direct Expenses and Indirect Expenses incurred in connection with the Manufacture of the Drug Substance or Drug Product, [***], such calculation being based upon accepted industry standards and the applicable Accounting Standard. Manufacturing Expenses shall not include any: [***].
Manufacturing Expenses means (a) with respect to a Co-Development mRNA Payload, BioNTech Product or a Co-Development Product that is Manufactured by a Third Party [***] paid by either Party or its Affiliate to such Third Party for such Co-Development mRNA Payload, Genevant LNP, BioNTech Product or Co-Development Product, and (b) with respect to a Co-Development mRNA Payload, Genevant LNP, BioNTech Product or Co-Development Product that is Manufactured directly by either Party or its Affiliate the Direct Expenses and Indirect Expenses incurred in connection with the Manufacture of the BioNTech Product or Co-Development Product [***]. Manufacturing Expenses shall not include any: (x) Manufacturing variances due to idle plant capacity, (y) expenses allocable to other products, or (z) any profit related to intercompany transfer pricing.
Manufacturing Expenses means: (a) with respect to a Compound or a Product that is Manufactured or Packaged by a Third Party, the actual purchase price paid by a Party or its Affiliate to such Third Party for such Compound or Product; and (b) with respect to a [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Compound or a Product that is Manufactured or Packaged directly by a Party or its Affiliate, the Direct Expenses incurred in connection with the Manufacture or Packaging of the Compound or the Product, facility expenses including [*]. Manufacturing Expenses shall not include any: (i) [*]; (ii) [*]; (iii) [*], or (iv) [*].
Manufacturing Expenses means Cost of Goods Sold (as defined in Exhibit 1.113), excluding any Manufacturing Improvement Expenses. [***] 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.
Manufacturing Expenses means all expenses incurred in accordance with the Accounting Standards, directly or indirectly, in connection with Manufacturing a pharmaceutical product, including without limitation the costs incurred for all materials (including devices sold as part of a Product for a single sales price, or included as part of a Product under Development), labor, access and use of a portion of a Manufacturing facility, reasonably allocable Manufacturing overhead and out-of-pocket costs paid to Third Parties, in each case including all FTE Expenses for FTEs who perform activities in furtherance of the foregoing, but in any event excluding any unreserved, allocated idle capacity costs and charges that exceed in the aggregate [* * *] of a manufacturing facility relating to or occasioned by unused manufacturing capacity not otherwise committed to Products.
Manufacturing Expenses means, with respect to a particular unit of Product or Inovio Device used in connection with the Global Phase 3 Study: (a) if Inovio or its Affiliate Manufactures the applicable Product or Inovio Device, the actual manufacturing cost of such Product or Inovio Device (as determined in accordance with U.S. GAAP consistently applied with its other products); or (b) if a Third Party Manufactures such Product or Inovio Device, the actual transfer price paid by Inovio or its Affiliate to such Third Party for the Manufacture of such Product or Inovio Device without any additional mark-up; in each case of (a) and (b), excluding the external costs of insurance and transportation, import and export taxes and fees, and similar charges, for such Product or Inovio Device.
Manufacturing Expenses means (a) with respect to a Compound or a Product that is Manufactured by a Third Party, the actual purchase price paid by a Party or its Affiliate to such Third Party for such Compound or Product, and (b) with respect to a Compound or a Product that is Manufactured directly by a Party or its Affiliate, the Direct Expenses and Indirect Expenses incurred in connection with the Manufacture of such Compound or Product, facility costs including depreciation, and overhead, such calculation being based upon accepted industry standards and applicable Accounting Standards, including any such expenses related to Manufacturing Development. Manufacturing Expenses shall not include any: (X) manufacturing variances due to idle plant capacity not allowed as a capitalized expense under applicable Accounting Standards, (Y) expenses allocable to other products, or (Z) any profit related to intercompany transfer pricing. *** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment. An unredacted version of this exhibit has been filed separately with the Commission.