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 [***].
Fully Burdened Manufacturing Cost means, with respect to any Preclinical Materials or Clinical Materials produced by IMMUNOGEN for GENENTECH under this Agreement, the sum of the following components: (a) the costs of goods produced, as determined by IMMUNOGEN in accordance with generally accepted accounting principles in the United States, consistently applied, including, without limitation, direct labor, material and product testing costs of such Preclinical Materials or Clinical Materials; (b) any Third Party royalty costs directly allocable to the manufacture or use of such Preclinical Materials or Clinical Materials; (c) all Allocable Overhead on the cost of goods under clause (a) above; and (d) any other costs borne by IMMUNOGEN, for the transport, customs clearance, duty, insurance and/or storage of such Preclinical Materials or Clinical Materials.
Fully Burdened Manufacturing Cost means Halozyme’s fully burdened cost to manufacture (or acquire from its third party manufacturer) and supply API, including without limitation costs for testing, packaging, shipping and an allocable share of corporate and overhead costs.
Examples of Fully Burdened Manufacturing Cost in a sentence
For all API supplied by Halozyme under Article 7, ViroPharma shall pay to Halozyme a price equal to *** percent (***%) of the Fully Burdened Manufacturing Cost to Halozyme to manufacture (or have manufactured), store and supply API.
In order to verify the Fully Burdened Manufacturing Cost comprising the Transfer Price, AcelRx shall provide to Grünenthal a written report of the calculation of the Fully Burdened Manufacturing Cost on a quarterly basis for the most recently completed calendar quarter.
Grünenthal shall have the right to cause an independent, certified public accounting firm reasonably acceptable to AcelRx to audit AcelRx’s records relating to the Fully Burdened Manufacturing Cost to confirm the amount of the costs and expenses reflected in such report.
The Fully Burdened Manufacturing Cost of supplying Jointly Funded Product/Indications for use in Development in the Shared Territory shall be included in Development Costs.
The Fully Burdened Manufacturing Cost for supply of Program DARTs and/or Licensed Products for clinical trials used by Servier in connection with the Development of a Program DARTs and/or Licensed Products outside a Global Development Plan shall be invoiced by MacroGenics on a quarterly basis.
More Definitions of Fully Burdened Manufacturing Cost
Fully Burdened Manufacturing Cost means, with respect to any Licensed Product supplied by or on behalf of Verastem to Licensee hereunder:
Fully Burdened Manufacturing Cost means [***]*.
Fully Burdened Manufacturing Cost means the actual cost of the production of either Clinical Product or Commercial Product, as the case may be, which shall be comprised of the sum of (a) the cost of goods produced as determined in accordance with U.S. generally accepted accounting principles as consistently applied by CTI, including, but not limited to, direct labor, packaging, and material and product testing costs incurred in connection with the manufacture or quality control testing of Clinical Product or Commercial Product, startup and validation costs associated with manufacturing capacity under this Agreement incurred prior to the first approval of a Submission for a Licensed Product, as well as overhead and amortized capital depreciation allocated in accordance with U.S. generally accepted accounting principles as consistently applied by CTI, and (b) all royalties (earned or paid up) payable to third parties under license(s) taken by CTI to patents or patent applications that, but for such license(s), would be infringed by the manufacture of Licensed Product. The determination of "Fully Burdened Manufacturing Cost" shall be subject to review by the Finance Committee under Section 8.08. In the case of any paid-up licenses, the cost of such licenses shall be fairly allocated between Licensed Product and other product(s) giving rise to payment obligations under such license.
Fully Burdened Manufacturing Cost means, with respect to any Preclinical Materials or Clinical Materials produced by IMMUNOGEN for ABX under this Agreement, the sum of the following components, as determined by IMMUNOGEN in accordance with generally accepted accounting principles in the United States, consistently applied, and consistent with the application given to other goods produced by IMMUNOGEN: (a) the costs of goods produced, including, without limitation, direct labor, material and product testing costs of such Preclinical Materials or Clinical Materials; (b) any Third Party royalty costs that are actually paid by IMMUNOGEN and are based solely and directly on the manufacture and sale to ABX of such Preclinical Materials or Clinical Materials; (c) all overhead costs incurred by IMMUNOGEN directly and solely attributable to the cost of goods under clause (a) above, including, without limitation, supervisory services, occupancy costs, payroll, information systems, human relations, purchasing, accounts receivable or accounts payable functions, and other general and administrative functions; and (d) any other costs borne by IMMUNOGEN directly and solely for the transport, customs clearance, duty and/or insurance for such Preclinical Materials or Clinical Materials to ABX hereunder.
Fully Burdened Manufacturing Cost means with respect to a Program DART or Licensed Product, the aggregate of internal and external costs of MacroGenics and its Affiliates to Manufacture such Program DART or Licensed Product, calculated as follows: (a) to the extent that MacroGenics or its Affiliates perform all or any part of the Manufacturing of such Program DART or Licensed Product, the direct material costs *** and FTE Costs for such Manufacturing of such Program DART or Licensed Product ***, all calculated in accordance with applicable Accounting Standards as consistently applied by MacroGenics or its Affiliates; and (b) to the extent that Manufacturing of such Program DART or Licensed Product is performed by a Third Party, the costs paid to such Third Party for such activities *** and the reasonable direct FTE Costs incurred by MacroGenics or any of its Affiliates in managing and overseeing the Third Party relationship, determined in accordance with applicable Accounting Standards as consistently applied by MacroGenics or its Affiliates. Fully Burdened Manufacturing Cost shall also include ***.
Fully Burdened Manufacturing Cost means, with respect to any Licensed Product (or the Compound contained therein) supplied by or on behalf of Tarsus to Lian:
Fully Burdened Manufacturing Cost means the fully-burdened aggregate reasonable direct and indirect costs and expenses incurred and recorded by a Party in Manufacturing a Product consisting solely of: