Amgen Development Costs definition

Amgen Development Costs means the Development Costs incurred by Amgen and its Affiliates.
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Amgen Development Costs means Amgen’s (and its Affiliates’) fully-burdened, world-wide development costs [*] related to development of Dmab, as more specifically set forth in the Development Costs Schedule.
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Amgen Development Costs has the meaning set forth in Section 8.2.2 (Amgen Costs).
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Examples of Amgen Development Costs in a sentence

  • Amgen shall keep complete and accurate records pertaining to Amgen Development Costs of Licensed Products in sufficient detail to permit Licensee to reasonably confirm the accuracy of all payments due hereunder with respect to Licensee's obligation to reimburse Amgen for Licensee's share of Amgen Development Costs, other than with respect to clinical drug substance and drug product supply of Licensed Products, pursuant to Section 8.9 (Development Cost Sharing).

  • Within [*] days after the end of each [*] Quarter, Amgen shall provide Licensee with a report specifying in reasonable detail the Amgen Development Costs incurred or paid by Amgen in such [*] Quarter, as well as any other costs for which Amgen is entitled reimbursement hereunder.

  • The Development Costs Example Schedule sets forth an example of the calculation of Licensee’s share of Amgen Development Costs.

  • Such records of Licensee and Amgen shall be open (in such form as may be available or reasonably requested by a certified public accountant in accordance with this Section 8.13(Audits)) to inspection for five (5) years following the end of the period to which they pertain; provided, however, such records of Amgen shall only be available with respect to Amgen Development Costs incurred by or on behalf of Amgen on a going forward basis from April 1, 2012.

  • For the purposes of this Section 8.9.3 (Payment Caps), payments of Licensee’s share of Amgen Development Costs payable pursuant to Section 8.9 (Development Cost Sharing) shall apply against the Annual Maximum in the [*] Quarter for which such costs are invoiced, without reference to when such payments are actually paid or payable hereunder (but provided that such payments are subsequently actually paid).

  • Amgen Development Costs may be attributed by Amgen to either the Calendar Quarter in which they are paid or incurred, but no amount shall be attributed to more than one Calendar Quarter.

  • Within thirty (30) days of the end of each Calendar Quarter, Amgen shall provide Collaborator with a report specifying in reasonable detail the Amgen Development Costs incurred or paid by Amgen in such Calendar Quarter, as well as any other costs for which Amgen is entitled reimbursement hereunder (such as those incurred pursuant to Section 4.18 (Transition in Oncology Development)).

  • Licensee shall pay Amgen its share of Amgen Development Costs in accordance with Section 8.12 (Payment Method) within [*] days after receiving Amgen’s report pursuant to Section 8.9.5 (Reports).

  • For purposes of calculating quarterly balancing payments as set forth in Section 8.2.4 (Balancing Payment for Global Development Costs) and Section 8.3.4 (Balancing Payment for Commercialization and Related Costs), Net Revenues, KKUS Development Costs, Amgen Development Costs, KKUS Commercialization Costs and Amgen Commercialization Costs will be converted from local currency (if different from $US) to $US in accordance with Section 9.3.3 (Conversions).

  • In addition to the other payments referenced herein, with respect to each Licensed Product, Novartis shall bear the percentage of Amgen Development Costs set forth in the “Novartis Share” column of the applicable chart below and Amgen shall bear the percentage of Novartis Development Costs set forth in the “Amgen Amgen Ref.

Related to Amgen Development Costs

  • 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:

  • Development Cost means the total of all costs incurred in the completion of a Development excluding Developer Fee, operating deficit reserves, and total land cost as typically shown in the Development Cost line item on the development cost pro forma.

  • 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.

  • Total Development Cost means the total of all costs incurred in the completion of a Development, all of which shall be subject to the review and approval by the Credit Underwriter and the Corporation pursuant to this rule chapter, and as further described in Rule 67-48.0075, F.A.C.

  • Commercialization Costs means the out-of-pocket costs and expenses incurred by Adapt or its Affiliates directly attributable to, or reasonably allocable to, the Commercialization of a Product. Commercialization Costs for a Product shall include, preparation of promotional, advertising, communication, medical, and educational materials relating to the Product and other Product literature and selling materials, activities directed to marketing of the Product, including purchase of market data, development and conduct of market research, advertising, public relations, public affairs and other communications with Third Parties regarding the Product; development and conduct of sales force training (including materials, programs and travel to and attendance at training programs) for medical representatives responsible for promoting the Product; and development and maintenance of sales bulletins, call reporting and other monitoring/tracking, sales force targeting, validation and alignment programs and documentation.

  • Patent Costs means the reasonable fees and expenses paid to outside legal counsel, and filing, maintenance and other reasonable out-of-pocket expenses paid to Third Parties, incurred in connection with the Prosecution and Maintenance of Patent Rights.

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

  • Economic development project means land and existing or planned improvements suitable for use by an industrial or commercial enterprise, or housing development, or the protection of the environment, including, but not limited to, groundwater or surface water. Economic development project includes necessary buildings, improvements, or structures suitable for and intended for or incidental to use as an industrial or commercial enterprise or housing development; and includes industrial park or industrial site improvements and port improvements or housing development incidental to an industrial or commercial enterprise; and includes the machinery, furnishings, and equipment necessary, suitable, intended for, or incidental to a commercial, industrial, or residential use in connection with the buildings or structures.

  • Improvement Costs means any additional expenditure on a fixed asset that materially increases the capacity of the asset or materially improves its functioning or represents more than 10% of the initial depreciation base of the asset;

  • Development Project means a project for the development of land within a project area.

  • Research Project means a discrete scientific endeavor to answer a research question or a set of research questions related to medical marijuana and is required for a medical marijuana research license.

  • 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;

  • Development Budget has the meaning set forth in Section 3.1.

  • Manufacturing Costs means, with respect to a given AquaBounty Product, the full-time equivalent costs (under a reasonable accounting mechanism to be agreed upon by the Parties) and out-of-pocket costs that AquaBounty or any of its Affiliates incurred in manufacturing such products, including costs and expenses incurred in connection with (a) the development or validation of any manufacturing process, formulations or delivery systems, or improvements to the foregoing; (b) manufacturing scale-up; (c) in-process testing, stability testing and release testing; (d) quality assurance/quality control development; (e) internal and Third Party costs and expenses incurred in connection with qualification and validation of Third Party contract manufacturers, including scale up, process and equipment validation, and initial manufacturing licenses, approvals and inspections; (f) packaging development and final packaging and labeling; (g) shipping configurations and shipping studies; and (h) overseeing the conduct of any of the foregoing. “Manufacturing Costs” shall further include: (i) to the extent that any such AquaBounty Product is manufactured by a Third Party manufacturer, the out-of-pocket costs incurred by AquaBounty or any of its Affiliates to the Third Party for the manufacture and supply (including packaging and labeling) thereof, and any reasonable out-of-pocket costs and direct labor costs incurred by AquaBounty or any of its Affiliates in managing or overseeing the Third Party relationship determined in accordance with the books and records of such Party or its Affiliates maintained in accordance with US GAAP; and (ii) to the extent that any such AquaBounty Product is manufactured by AquaBounty or any of its Affiliates, direct material and direct labor costs attributable to such product, as well as reasonably allocable overhead expenses, determined in accordance with the books and records of AquaBounty or its Affiliates maintained in accordance with US GAAP.

  • 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.

  • 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.

  • Patent Expenses means the fees and expenses of outside counsel and payments to Third Parties incurred after the Effective Date in connection with the preparation, filing, prosecution and maintenance of the Licensed Patents, the Joint Collaboration Patents, and the Shire Patents covering Compound and Collaboration Products, including the costs of patent interference and opposition proceedings, net of any reimbursement of such expenses by Third Parties.

  • Public improvement costs means the costs of:

  • spatial development framework means the Mhlontlo Municipal Spatial Development Framework prepared and adopted in terms of sections 20 and 21 of the Act and Chapter 2 of this By-Law;

  • Development Area means that area to which a development plan is applicable.

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

  • Development Fee means a fee for the packaging of a Property, including negotiating and approving plans, and undertaking to assist in obtaining zoning and necessary variances and necessary financing for the Property, either initially or at a later date.

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

  • Development Term means the period commencing on the Closing Date and ending on the earlier of (a) the Option Closing Date or (b) the date the Option terminates or expires other than by exercise.

  • Routine Patient Costs means all health care services that are otherwise covered under the Group Contract for the treatment of cancer or other Life-threatening Condition that is typically covered for a patient who is not enrolled in an Approved Clinical Trial.

  • FTE means full-time equated.