Development and Regulatory Costs definition

Development and Regulatory Costs means the costs incurred by ZAI or for its account, during the term of and pursuant to this Agreement, that are reasonably allocable to the Development of a Licensed Product and that are directed to achieving Regulatory Approval of such Licensed Product in the Partner Territory. The Development and Regulatory Costs shall include amounts that ZAI pays to Third Parties involved in the Development of a Licensed Product for the Partner Territory, and all internal costs incurred by ZAI in connection with the Development of such Licensed Product. Development and Regulatory Costs include the following: [*]; in each case incurred prior to the receipt of the applicable Regulatory Approval for a Licensed Product. For clarity, Development and Regulatory Costs do not include the costs of [*].
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Development and Regulatory Costs means all internal and external costs and expenses (including the cost of allocated FTEs at the FTE Rate) incurred by a Party and its Affiliates (“Costs”) during the Term in connection with the Development of Licensed Compounds or Licensed Products in accordance with the Global Development Plan or Territory Development Plan:
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Development and Regulatory Costs means all internal and external costs and expenses (including the cost of allocated FTEs at the FTE Rate) incurred by a Party and its Affiliates (“Costs”) during the Term in connection with the Development of Licensed Compounds or Licensed Products in accordance with the Global Development Plan or Territory Development Plan: (a) with respect to BeiGene, including, as applicable: (i) all Costs incurred by BeiGene or its Affiliates in performing Development activities in or for the Territory (including [* * *]); (ii) all Costs incurred by BeiGene or its Affiliates for Licensed Compounds or Licensed Products or any other materials (such as non‑Party comparator drugs and placebo) reasonably required to be obtained or made for use in Clinical Trials of or related to a Licensed Compound or Licensed Product; and (iii) all Costs incurred by BeiGene or its Affiliates associated with obtaining, maintaining and renewing Regulatory Submissions and Regulatory Approvals for a Licensed Product; (b) with respect to AssemblyBio, including, as applicable: (i) all Costs incurred by AssemblyBio or its Affiliates in performing Development activities in and for the Territory (including [* * *]); and (ii) all Costs incurred by AssemblyBio or its Affiliates for Licensed Compounds or Licensed Products or any other materials (such as non‑Party comparator drugs and placebo) reasonably required to be obtained or made for use in Clinical Trials of or related to a Licensed Compound or Licensed Product in and for the Territory (but excluding any such Costs taken into account in the calculation of Fully Burdened Manufacturing Costs); in both cases (a) and (b), (x) as set forth in the Global Development Budget or the Territory Development Budget, (y) incurred in relation to activities expressly set forth in the Global Development Plan, the Territory Development Plan or this Agreement, and (z) evidenced by written records reasonably acceptable to the other Party; provided that any Costs [* * *] may be counted as Development and Regulatory Costs [* * *] (1) [* * *], (2) [* * *], and (3) [* * *]. For clarity, any external or Third Party costs are included in the Development and Regulatory Costs in the amount actually incurred without any markup. All Development and Regulatory Costs must be recorded in accordance with the applicable Accounting Standard, and either directly attributed to or fairly allocable to the Development activities of the Licensed Compounds and Licensed Products as conduc...
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Examples of Development and Regulatory Costs in a sentence

  • These items include NGX Collateral Costs and Counterparties Collateral Costs, NGX Trading Charges and Transaction Fees, AESO Trading Charges, AESO Collateral Costs, External EPSP Development and Regulatory Costs, RAM charges, and Uplift Charges calculated as shown in Section C of Schedule “F”.

  • These items include NGX Collateral Costs and Other Credit Costs (calculated in accordance with Appendix F.1 to Schedule “F” and following the methodology provided for in the illustrative model in Appendix F.2 to Schedule “F”), NGX Trading Charge and Transaction Fees, AESO Trading Charges, AESO Collateral Costs and Backstop Collateral Costs, External EPSP Development and Regulatory Costs, RAM charges, and Uplift Charges calculated as shown in Section D of Schedule “F”.

  • ZAI shall have sole responsibility for resourcing and funding, and shall bear one hundred percent (100%) of the Development and Regulatory Costs with respect to the Development of the Licensed Product(s) for the Partner Territory.

  • Amounts paid by BeiGene for clinical supply of Licensed Products under this Agreement will be included among Development and Regulatory Costs and shared by the Parties in accordance with Section 5.4.

  • A replay of the webcast will be available for a limited time at www.ingredion.com.About the CompanyIngredion Incorporated (NYSE: INGR) headquartered in the suburbs of Chicago, is a leading global ingredient solutions provider serving customers in more than 120 countries.

  • EDR is the External EPSP Development and Regulatory Costs for the Month, determined as described in section 4.12.NGXTC is the NGX Trading Charge and Transaction Fees, determined as described in section 4.13.RAM is the Retailer Adjustment to Market forecast for the Month, determined as described in section 4.14.UC is the Uplift Charges, determined as described in section 4.15.

  • KNC shall pay the Development and Regulatory Costs incurred in connection with the efforts to obtain such Approvals from the FDA; however, the parties agree to share equally any applicable Clinical Trial Costs to obtain such Approvals from the FDA.

  • Each Party shall bear its own Development and Regulatory Costs incurred by it, subject to reimbursement as provided herein.

  • BeiGene shall provide AssemblyBio with [* * *] written reports (which may be in the form of PowerPoint or Excel presentations), at least [* * *], summarizing its, its Affiliates’ and its sublicensees’ Development of Licensed Products, including a summary of the results of such Development and the Development and Regulatory Costs incurred in connection with such Development activities, which reports shall be in English (the “BeiGene Development Report”).

  • Upon termination of this Agreement resulting from Section 11.1(a) above, Spectranetics agrees to pay to KNC the reasonable Development and Regulatory Costs incurred by KNC for development and regulatory services efforts for which Milestones Payments had not yet been earned at the effective date of termination.


More Definitions of Development and Regulatory Costs

Development and Regulatory Costs means the costs incurred by either Party or for its account specifically identifiable to the development of the Aviron Product for Regulatory Approval in the Territory and shall consist of (i) [ * ] costs associated with the conduct of the [ * ]; (ii) Cost of Goods Shipped of any Aviron Product [ * ]; and (iii) direct labor and materials and out-of-pocket costs associated with the [ * ] in the Territory all as specified in the Development Plan and approved by the Steering Committee, all calculated in accordance with reasonable cost accounting methods, consistently applied by the Party performing the work.
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Development and Regulatory Costs means the costs incurred by either Party or for its account specifically identifiable to the development of the Aviron Product for Regulatory Approval in the Territory and shall consist of (a) [*] costs associated with the conduct of the [*]; (
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Development and Regulatory Costs means the cost for the design, prototyping, development, testing and evaluation of the Products as set forth in the Development Plan and all other costs directly associated with obtaining Approvals from the FDA, including without limitation the costs set forth on Schedule 1(b) hereto; provided however, that “Development and Regulatory Costs” shall in no event include Clinical Trial Costs.
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Related to Development and Regulatory Costs

  • Regulatory Costs are, collectively, future, supplemental, emergency or other changes in Reserve Percentages, assessment rates imposed by the Federal Deposit Insurance Corporation, or similar requirements or costs imposed by any domestic or foreign Governmental Authority and related in any manner to a Fixed Rate.

  • Development Activities means those Development activities undertaken by or on behalf of a Party or its Affiliates with respect to the Product in the Field.

  • 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.

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

  • Development Plans means a coherent set of operations defined and financed exclusively by the OCTs in the framework of their own policies and strategies of development, and those agreed upon between an OCT and the Member State to which it is linked;

  • 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 Program means the implementation of the development plan.

  • 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.

  • Development Work means all work and services necessary or desirable in connection

  • 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.

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

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Manufacturing Costs means the costs of Processing that generate Manufacturing Proceeds received by Grantor.

  • Program Costs means all necessary and incidental costs of providing program services.

  • Development Budget means the cost categories listed on Pages 8 - 11 in Form 3 that are directly related to the proposed Project as submitted in the Application. Indirect or off-site costs not directly related to the development of the project are not valid or eligible costs.

  • Development Site means any parcel or lot on which exists or which is intended for building development other than the following:

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • Project Plan means the document to be developed by the Contractor and approved by WTL, based on the requirements of the Contract and the Preliminary Project Plan included in the Contractor’s bid. For the sake of clarity, the Agreed and Finalized Project Plan” refers to the version of the Project Plan submitted by the contractor after receiving the letter of Award and the same approved by WTL. The project plan may be changed/ modified during the course of the project. Should the Project Plan conflict with the provisions of the Contract in any way, the relevant provisions of the Contract, including any amendments, shall prevail.

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

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

  • Development Data means all non-clinical, clinical, technical, chemical, safety, and scientific data and information and other results, including relevant laboratory notebook information, screening data, and synthesis schemes, including descriptions in any form, data and other information, in each case, that is generated by or resulting from or in connection with the conduct of Development of Products, to the extent that the same are Controlled by or in Adapt’s or its Affiliates’ or Adapt’s Commercial Sublicensees’ possession, and may be disclosed to Lightlake without violating any obligation under Applicable Law.

  • Development Charges or “DC” shall mean the amount charged by the Company from the Applicant(s) towards carrying out the developmental works inside or around the Project, including but not limited to the payment of the following:

  • Development Schedule shall have the meaning set forth in Section 1.1.

  • Commercialization or “Commercialize” means any and all activities undertaken at any time for a particular Licensed Product and that relate to the manufacturing, marketing, promoting, distributing, importing or exporting for sale, offering for sale, and selling of the Licensed Product, and interacting with Regulatory Authorities regarding the foregoing.

  • Collaboration Product means any pharmaceutical product in finished form that contains a Collaboration Compound, either as the sole active ingredient or in combination with one or more other active ingredients, and all present and future formulations, dosages and dosage forms thereof.

  • Phase III Trial means a Clinical Trial of an investigational product in subjects that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to generate data and results that can be submitted to obtain Regulatory Approval as described in 21 C.F.R. 312.21(c), or a comparable Clinical Trial prescribed by the relevant Regulatory Authority in a country other than the United States.