142 Manufacturing Costs Clause Examples for Any Agreement
The Manufacturing Costs clause defines which expenses are considered part of the costs incurred during the production of goods. Typically, this includes direct costs such as raw materials, labor, and factory overhead, and may specify whether indirect costs or certain administrative expenses are included or excluded. By clearly outlining what constitutes manufacturing costs, this clause helps prevent disputes over billing and reimbursement, ensuring both parties have a shared understanding of allowable charges.
POPULAR SAMPLE Copied 15 times
Manufacturing Costs. Patheon shall be allowed to adjust the Fees: (i) for costs associated with the conversion of Granulations and Components into Drug Product (the “Conversion Costs”) in respect of the Drug Product based on the most recently available final Producers’ Price Index for Pharmaceutical Product as published by the U.S. Bureau of Labor Statistics or any governmental successor thereto (“PPI”) using the procedure set forth in Section 4.3 and (ii) for Component Costs to pass on the actual amount of any increase or decrease in such costs without xxxx-up. For each Contract Year in which Patheon is entitled to adjust the Fees Patheon shall provide Client with written notice of any change in the Fees within 30 days of receipt by Patheon of the Annual Forecast. The Parties agree that the Fees shall not be adjusted more than once per Contract Year, however this limitation shall not include price adjustments under section 4.3 or 4.4. In addition, notwithstanding anything herein to the contrary, Manufacturing Fees associated with Conversion Costs shall not be increased by greater than [***]% per annum in any Contract Year during the Term. There shall be no similar limitation in terms of increases in Component Costs which shall be passed on to Client in an amount equal to the actual increase paid by Patheon without markup.
Manufacturing Costs. Notwithstanding any provisions in this Supply Agreement or the License Agreement to the contrary, from and after the time that Chiron exercises its back-up supply rights in accordance with the provisions of this Section 11.6, * CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED WITH THE COMMISSION Chiron shall be entitled, subject to the provisions set forth below in this Section 11.6(g) and Section 11.6(h), to offset Chiron's Manufacturing Cost for units of Filled Product against any royalties payable by Chiron to Cubist under the License Agreement from sales in the Territory of Licensed Product consisting of such units of such Filled Product. Chiron's Manufacturing Costs shall be determined in accordance with the following subparagraphs (i), (ii) and (iii) of this Section 11.6(g):
(i) BACK-UP SUPPLY FOR FILLING AND FINISHING ONLY. If Chiron exercises its back-up supply rights under this Section 11.6 with respect to Filled Product but not API and in the event that Cubist continues to supply API to Chiron pursuant to this Supply Agreement at Cubist's Manufacturing Cost for such API, then, for purposes of this Section 11.6(g) and notwithstanding anything in Section 7.1(b) to the contrary, Chiron's Manufacturing Cost for Filled Product shall consist of (i) the transfer price payable by Chiron to Cubist in connection with supply of API and (ii) Chiron's Manufacturing Cost attributable only to filling and finishing units of Filled Product up to an amount equal to [*] of the portion of Cubist's Manufacturing Cost immediately prior to the exercise by Chiron of its back-up supply rights pursuant to this Section 11.6 that is attributable to filling and finishing units of Filled Product.
(ii) BACK-UP SUPPLY FOR BOTH API AND FILLED PRODUCT. If Chiron exercises its back-up supply rights under this Section 11.6 with respect to both API and Filled Product, then, for purposes of this Section 11.6(g) and notwithstanding anything in Section 7.1(b) to the contrary, Chiron's Manufacturing Cost for Filled Product shall be no greater than an amount equal to [*] of the Transfer Price in effect immediately prior to the exercise by Chiron of its back-up supply rights pursuant to this Section 11.6.
Manufacturing Costs. Surface will be responsible for [***] of all Manufacturing Costs incurred by or on behalf of Surface relating to Option Target Antibody Candidates, including CD47 Option Target Antibody Candidates, for use in the Option Target Research Programs. For clarity, responsibility for Manufacturing Clinical Study material will be allocated as set forth in under Sections 8.3 or 8.4, as applicable.
Manufacturing Costs. In the event of termination by Merck pursuant to Section 6.3 or 6.7 above, Merck shall be entitled to *** (as defined herein) incurred by Merck for its Compound Delivered for the Study. *** .
Manufacturing Costs. During the period that HMI is responsible for Manufacturing any Candidate or Product, NVS will be responsible for the documented Manufacturing Costs actually incurred by HMI directly in connection with the Manufacture and supply of such Candidate and Product in accordance with the Research Plans, Development Supply Agreement(s), and Commercial Supply Agreement(s), as applicable; provided, further, that: (a) Manufacturing Costs for Candidates shall (i) continue until the end of [***], (ii) be set forth in the applicable JSC approved Research Budget, and (iii) be subject to the [***]; (b) Candidates and Products Manufactured and supplied pursuant to the applicable Development Supply Agreement shall be supplied to NVS at a transfer price equal to [***]; and (c) Candidates and Products Manufactured for Pivotal Clinical Trials and Commercialization activities and supplied pursuant to the Commercial Supply Agreement shall be supplied to NVS at a transfer price equal to [***].
Manufacturing Costs. 8.1.2.1. Surface will be responsible for [***] of all Manufacturing Costs relating to T1 Antibody Candidates incurred by or on behalf of Surface to support the T1 Research Program.
8.1.2.2. Novartis will pay to Surface [***] of reasonable Manufacturing Costs relating to the first Phase 1 Safety Study for T1 Antibody Candidates and T1 Licensed Products set forth in the Novartis approved budget for such Phase 1 Safety Study.
8.1.2.3. Other than the first Phase 1 Safety Study for the T1 Antibody Candidates and T1 Licensed Products, Novartis will be responsible for [***] of all Manufacturing Costs relating to T1 Antibody Candidates and T1 Licensed Products for use in the Research, Development and Commercialization of such T1 Antibody Candidates and T1 Licensed Products in the Novartis Territory incurred by or on behalf of Novartis.
Manufacturing Costs. 8.4.2.1. Subject to Section 8.2.3, Surface will be responsible for [***] of all Manufacturing Costs relating to Global Antibody Candidates and Global Licensed Products incurred by or on behalf of Surface to support the first Phase 1 Safety Study for Global Antibody Candidates and Global Licensed Products.
8.4.2.2. Other than the first Phase 1 Safety Study for the Global Antibody Candidates and Global Licensed Products (subject to Section 8.2.3), Novartis will be responsible for [***] of all Manufacturing Costs relating to Global Antibody Candidates and Global Licensed Products for use in the Research, Development and Commercialization of such Global Antibody Candidates and Global Licensed Products by or on behalf of Novartis in the Novartis Territory.
Manufacturing Costs. Zosano shall be responsible for development and scale up of the manufacturing process and for the manufacturing of clinical supply of the Licensed Product for Novo Nordisk until completion of the Technology Transfer (i.e., for the preclinical studies, Phase 1 Clinical Trial(s), Phase 2 Clinical Trial(s) and, at Novo Nordisk’s option, Phase 3 Clinical Trial(s), including any necessary validation studies). The Licensed Product will be supplied by Zosano to Novo Nordisk at [**]. Zosano shall own and shall be responsible for filing for and maintaining all necessary manufacturing approvals and permits to enable Zosano to manufacture, supply, test and store clinical supplies of Licensed Product as may be required or reasonably requested by Novo Nordisk. All reasonable documented costs associated with any modifications to Zosano’s facilities or other capital expenditures or committed resources required to manufacture, supply, test or store clinical supply of Licensed Product, in each case requested or approved in writing by Novo Nordisk, shall be borne by Novo Nordisk.
Manufacturing Costs. Athersys shall keep, and shall require all Third-Party manufacturers of the Clinical Development Candidates and/or Cell Therapy Products to keep, accurate records in sufficient detail concerning the Manufacturing Costs. Angiotech shall be entitled to engage an independent public accounting firm to audit the Manufacturing Costs as provided in, and in accordance with, Section 7.6. For this purpose, Athersys itself shall keep, and to the extent that Athersys has obtained records or documents from its Third-Party manufacturers shall keep, such account books and related records or documents for a period of at least seven (7) years after the end of the fiscal year to which the Manufacturing Costs relate.
Manufacturing Costs. (a) DICERNA, at its sole cost, shall manufacture or obtain DsiRNA-Based Compound for the conduct of the Research Collaboration for the Initial Target