Indirect Manufacturing Costs has the meaning set forth in Section 6.11.
Indirect Manufacturing Costs means the reasonable and allocated internal costs and out-of-pocket costs, incurred or accrued by Hapbee in connection with the manufacture of the Authorized Product or any component thereof, including costs arising from or associated with (i) freight, carrier insurance, and other transportation charges directly related to the delivery or distribution of the Authorized Product, (ii) storage and warehousing, (iii) taxes, duties, or other governmental charges (including any tax such as a value added or similar tax, other than any taxes based on income), but excluding indirect and overhead costs (e.g., costs associated with human resources, business development, and executive management).
Indirect Manufacturing Costs shall include allocations of indirect factory overhead and site support costs, including but not limited to utilities, quality, planning, engineering, maintenance, safety, site science and technology, and depreciation on indirect capital assets, procurement, warehousing, and corporate services; shipping costs; all costs incurred by a Party in connection with audits conducted pursuant to the Clinical Quality Agreements; any non-refundable or non-creditable indirect taxes, customs and excise duties, or similar taxes paid or payable by any Third Party or Affiliate in relation to the Manufacture of any portion of such Compound. Allocations shall be based on such Compound’s utilization relative to a manufacturing site’s total activity.
Examples of Indirect Manufacturing Costs in a sentence
In the event of termination by Merck pursuant to Section 6.2, 6.3 or 6.7 above, Merck shall be entitled to reimbursement by Antigen Express for the Direct Manufacturing Costs and Indirect Manufacturing Costs (as defined herein) incurred by Merck for its Compound Delivered for the Study.
In the event Merck Compound is lost or damaged by Antigen Express after Delivery, Merck shall provide additional Merck Compound (if available for the Study) to Antigen Express; provided that Antigen Express shall reimburse Merck for the Direct Manufacturing Costs and Indirect Manufacturing Costs (as such terms are defined in Section 6.11) of such replaced Merck Compound; and provided further that Merck shall have no obligation to provide additional Merck Compound more than once.
Provided the Parties do not otherwise dispute the circumstances of termination, in the event of termination by Merck pursuant to Section 6.2 or 6.3 above, Merck shall be entitled to reimbursement by BioLineRx for the Direct Manufacturing Costs and Indirect Manufacturing Costs (as defined herein) incurred by Merck for its Compound Delivered for the Study.
The Supplier shall calculate its allocation of Indirect Manufacturing Costs per Product by dividing the Indirect Manufacturing Costs across the Budget Order Volume (the "Indirect Manufacturing Cost Product Allocation").
Indirect Manufacturing Costs are allocated to products using allocation methodologies such as [*].
More Definitions of Indirect Manufacturing Costs
Indirect Manufacturing Costs means costs which are indirectly attributed to the manufacture of the Products, as set out in the "indirect costs" section of the FOS.
Indirect Manufacturing Costs shall include [***]. Allocations shall be based on such Compound’s utilization relative to a manufacturing site’s total activity. “Manufacturing Costs” shall mean the Direct Manufacturing Costs and the Indirect Manufacturing Costs.
Indirect Manufacturing Costs shall be calculated consistent with GAAP and include allocations of indirect factory overhead and site support costs, including but not limited to utilities, quality, planning, engineering, maintenance, safety, site science and technology, and depreciation on indirect capital assets, procurement, warehousing, and corporate services. Allocations shall be based on each Compound’s utilization relative to a manufacturing site’s total activity. In the event of termination by Antigen Express pursuant to Section 6.3 or 6.7 above, and in order to complete the Study it is necessary for Antigen Express to purchase Merck Compound, Merck shall reimburse Antigen Express’ out of pocket costs for the purchase of Merck Compound (from a Third Party) necessary to complete the Study as contemplated by the Protocol; provided, however, that in no event shall Merck’s obligation to reimburse Antigen Express subject to this sentence exceed one hundred thousand US Dollars ($100,000) in the aggregate.
Indirect Manufacturing Costs means the reasonable and allocated internal costs and out-of-pocket costs, incurred or accrued by Nativis in connection with the Manufacture of the Licensed Product or any component thereof, including costs arising from or associated with (i) freight, carrier insurance, and other transportation charges directly related to the delivery or distribution of the Licensed Product, (ii) storage and warehousing, (iii) taxes, duties, or other governmental charges (including any tax such as a value added or similar tax, other than any taxes based on income), but excluding indirect and overhead costs (e.g., costs associated with human resources, business development, and executive management). For clarity, to the extent that a Third Party manufacturer Manufactures all or a portion of the Licensed Product, then the actual cost of the Third Party expense shall be billed at direct cost without mxxx-up, and in any event no double-counting of expenses will apply with respect to costs included in the calculation of Manufacturing Costs.
Indirect Manufacturing Costs shall include [***]. Allocations shall be based on such Compound’s utilization relative to a manufacturing site’s total activity. “Manufacturing Costs” shall mean the Direct Manufacturing Costs and the Indirect Manufacturing Costs. [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
Indirect Manufacturing Costs shall include ***. Allocations shall be based on such Compound’s utilization relative to a manufacturing site’s total activity. Upon *** prior notice from Syndax, Alliance shall permit an independent certified public accounting firm of nationally recognized standing selected by Syndax and reasonably acceptable to Alliance, to examine, at Syndax’s sole expense, the relevant books and records of Alliance and its Affiliates as may be reasonably necessary to verify the Manufacturing Costs. An examination by Syndax under this Section 8.7.2(b) shall occur not more than *** in any calendar year and shall be ***. The accounting firm shall be provided access to such books and records at Alliance’s or its Affiliates’ facility(ies) where such books and records are normally kept and such examination shall be conducted during Alliance’s normal business hours. Alliance may require the accounting firm to sign a reasonably acceptable non-disclosure agreement before providing the accounting firm with access to Alliance’s or its Affiliates’ facilities or records. Upon completion of the audit, the accounting firm shall provide both Alliance and Syndax a written report disclosing any discrepancies in the reports submitted by Alliance and the specific details concerning any discrepancies. No other information shall be provided to Syndax. Notwithstanding any provision of this Agreement to the contrary (a) all reports and financial information of Alliance, its Affiliates or its sublicensees which are provided to or subject to review by Syndax under this Section 8.7.2(b) shall be deemed to be Alliance’s Confidential Information and subject to the provisions of Article 9.
Indirect Manufacturing Costs shall be calculated consistent with GAAP and include allocations of indirect factory overhead and site support costs, including but not limited to utilities, quality, planning, engineering, maintenance, safety, site science and technology, and depreciation on indirect capital assets, procurement, warehousing, and corporate services. Allocations shall be based on each Compound’s utilization relative to a Manufacturing Site’s total activity.