Separate Development Costs definition

Separate Development Costs means, with respect to a particular Separate Indication, the actual and direct costs and expenses reasonably incurred after the Effective Date of the Fourth Amendment by the applicable Advocating Party and its Affiliates or for its account, as calculated in accordance with, if Onyx is the Advocating Party, United States generally accepted accounting principles consistently applied or, if Bayer is the Advocating Party, international financial reporting standards consistently applied, that are specifically identifiable or reasonably and consistently allocable to the Development of the Approved Product for such Separate Indication (but excluding all Listed Trials, if any, for such Separate Indication) and that are directed to obtaining approval from the FDA and/or EMA of a Drug Approval Application for the Approved Product for such Separate Indication. The Separate Development Costs shall include amounts, without xxxx-up, that the Advocating Party pays to Third Parties involved in such Development work, and all internal costs incurred by the Advocating Party and costs reasonably incurred by Bayer for services requested by Onyx (if Onyx is the Advocating Party) in connection with such Development work. Separate Development Costs shall include the following to the extent that the necessary information or data is not in Bayer’s possession or Control (if Bayer is the Advocating Party) or provided to Onyx by Bayer (if Onyx is the Advocating Party): (a) all pre-clinical costs, such as costs for toxicology, pharmacokinetics, pharmacological studies specifically directed to the Separate Indication; (b) costs of clinical trials (other than Listed Trials) of the Approved Product for the Separate Indication, including ethics committee fees, investigators’ fees, investigators’ meeting costs, hospital fees, fees for clinical research organizations’ services; (c) costs of manufacturing or procuring the Approved Product, comparators and placebos, as applicable, for use in Development activities directed toward the Separate Indication, as well as the direct costs and expenses of disposal of drugs and other supplies used in such
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Examples of Separate Development Costs in a sentence

  • Bayer’s obligation to pay Onyx the Separate Development Costs shall, in the case of costs for services provided by Bayer, be [ * ] of the costs representing services provided by Bayer to Onyx.

  • In all cases in which a payment is conditioned upon Price Approval, if Price Approval is required in the European Union, Bayer’s obligation to pay [ * ] of the Separate Development Costs shall be conditioned upon Price Approval being granted in [ * ] major countries of the European Union.

  • If Onyx conducts one or more Separate Development Programs and Bayer obtains Drug Approval of the Product from the FDA or EMA with respect to one or more Separate Indications based upon data generated pursuant to a Separate Development Program, Bayer shall pay to Onyx [ * ] of the Separate Development Costs (or such greater amount as set forth below) with respect to each and every such Separate Indication (with such amounts subject to Bayer’s right to audit as provided in Section 4.7).

  • Upon such Drug Approval and Price Approval (if any), Bayer shall pay Onyx the Separate Development Costs as provided in Section 4.2 (with such amounts subject to Bayer’s right to audit as provided in Section 4.7) and Bayer shall commercialize and promptly launch the Product for such Separate Indication as if the Separate Indication had been developed internally by Bayer (and not pursuant to a Separate Development Program).

  • In the case of any Separate Development Program resulting from the discontinuance of activities by Bayer, Bayer shall be responsible for the costs incurred by Bayer, and Onyx shall bear the responsibility for the costs to transition the development activities from Bayer to Onyx, subject to reimbursement of such costs as Separate Development Costs under this Agreement.

Related to Separate Development Costs

  • site development plan means a dimensioned plan drawn to scale that indicates details of the proposed land development, including the site layout, positioning of buildings and structures, property access, building designs and landscaping;

  • 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.

  • 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.

  • Commercialization Costs means the sum of the following costs and expenses incurred by the Parties or their respective Affiliates, in Commercializing the Shared Products (and related Manufacturing activities) in the Territory, in each case, to the extent incurred in accordance with the Commercialization Plan and Commercialization Budget:

  • Individual development account means a contract between an account holder and a fiduciary organization, for the deposit of funds into a financial institution by the account holder, and the deposit of matching funds into the financial institution by the fiduciary organization, to allow the account holder to accumulate assets for use toward achieving a specific purpose approved by the fiduciary organization.

  • Mixed use development means a Building used, designed or intended for Residential and Non-Residential uses, where:

  • Operation and Maintenance Costs means the costs of:

  • sustainable development means development which meets the needs of the present without compromising the ability of future generations to meet their own needs.

  • 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.

  • experimental development means acquiring, combining, shaping and using existing scientific, technological, business and other relevant knowledge and skills with the aim of developing new or improved products, processes or services. This may also include, for example, activities aiming at the conceptual definition, planning and documentation of new products, processes or services;

  • Commercial Development means any development on private land that is not heavy industrial or residential. The category includes, but is not limited to: hospitals, laboratories and other medical facilities, educational institutions, recreational facilities, plant nurseries, car wash facilities, mini-malls and other business complexes, shopping malls, hotels, office buildings, public warehouses and other light industrial complexes.

  • Non-profit housing development means development of a building or structure intended for use as residential premises by,

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

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

  • Major development means an individual “development,” as well as multiple developments that individually or collectively result in:

  • Existing development means development, other than that associated with agricultural or forest management activities, that meets one of the following criteria:

  • Development Fees means fees imposed to offset capital costs of providing public infrastructure, public safety or other public services to a development and authorized pursuant to A.R.S. Section 9-463.05, A.R.S. Section 11-1102 or A.R.S. Title 48 regardless of the jurisdiction to which the fees are paid.

  • 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 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.

  • Social development company means a company whose primary purpose in Sudan is to provide humanitarian goods or services, including medicine or medical equipment, agricultural supplies or infrastructure, educational opportunities, journalism-related activities, information or information materials, spiritual-related activities, services of a purely clerical or reporting nature, food, clothing, or general consumer goods that are unrelated to oil-related activities, mineral extraction activities, or power production activities.

  • Development Officer means the Development Officer appointed by the Council of the Municipality.

  • Patent Costs means the reasonable, documented, out-of-pocket costs and expenses paid to outside legal counsel, and filing and maintenance expenses, [***] in Prosecuting and Maintaining Patents.

  • Temporary clean coal technology demonstration project means a clean coal technology demonstration project that is operated for a period of five years or less and that complies with the SIP and other requirements necessary to attain and maintain the national ambient air quality standards during the project and after the project is terminated.

  • Initial Development Plan has the meaning set forth in Section 3.2(b).