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 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 [*]; (b) Cost of Goods Shipped of any Aviron Product [*]; and (c) direct labor and materials and out-of-pocket costs associated with the [*] in the Territory as specified in the Development Plan and approved by the Steering Committee, and all calculated in accordance with reasonable cost accounting methods, consistently applied by the Party performing the work.
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Examples of Development and Regulatory Costs in a sentence

  • 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.

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

  • 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.

  • 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.

  • If the JDC approves by consensus such New Development Proposal, (i) the Parties will, through the JDC, update the Territory Development Plan to include the Development activities proposed in the New Development Proposal, and (ii) the Development and Regulatory Costs incurred with respect to the Development activities proposed in the approved New Development Proposal will be subject to Section 5.4.

  • Each Party will keep (and will cause its Affiliates and sublicensees to keep) complete, true and accurate books and records in sufficient detail for the other Party to determine payments due to such other Party under this Agreement, including Licensed Product royalty payments and for each Party to calculate Development and Regulatory Costs hereunder.

  • KNC shall have the responsibility for seeking the FDA Approvals (but not for CE Marking or for Approvals outside of the United States) on Spectranetics’s behalf and in Spectranetics’s name for the Products and funding the Development and Regulatory Costs in connection therewith.

  • 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”).

  • 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.

  • For clarity, all Development and Regulatory Costs covered under this Section 5.4 will be subject to the restrictions set forth in the definition of “Development and Regulatory Costs”, including clauses (x), (y) and (z) and the treatment of budget overage thereunder.


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 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 activities which are normally undertaken for the development, construction, repair, renovation, rehabilitation or conversion of buildings for residential purposes, including the acquisition of property;

  • 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:

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

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

  • 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 the conduct of preclinical and clinical trials, the compilation of the regulatory dossier concerning Licensed Products and the conduct of other work necessary or useful for obtaining Regulatory Approval of Licensed Products.

  • 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 shall have the meaning set forth in Section 3.3.

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

  • Clinical Studies means Xxxxx 0, Xxxxx 0, Xxxxx 0, Xxxxx 3, and such other tests and studies in human subjects that are required by Applicable Law, or otherwise recommended by the Regulatory Authorities, to obtain or maintain Regulatory Approvals for a Licensed Product for one (1) or more indications, including tests or studies that are intended to expand the Product Labeling for such Licensed Product with respect to such indication.

  • Project Plan means the document to be developed by the Contractor and approved by Webel Technology Ltd., 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 Webel Technology Ltd. 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 any and all research data, pharmacology data, chemistry, manufacturing and control data, preclinical data, clinical data and all other documentation (including raw data) compiled, developed or generated with respect to the Compound or Product.

  • 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.

  • Development Works means the external development works and internal development works on immovable property;

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.