Product Development means (a) with respect to the U.S. Territory, the conduct by King and its Affiliates of additional clinical studies of a Product that has previously received Regulatory Approval from the FDA, which additional clinical studies are conducted using CTM that is in the same formulation and dosage form as the Product for which Regulatory Approval was previously obtained, and (b) with respect to the ROW, the conduct by King, its Affiliates, or its Sublicensees of clinical studies of a Product, which additional clinical studies are conducted using CTM that is in the same formulation and dosage form as the Product for which Regulatory Approval was previously obtained in the U.S. Territory (or if Regulatory Approval has not yet been obtained in the U.S. Territory, then using CTM in the same formulation(s) and dosage form(s) then being utilized by PTI under the Development Plan for such Product in the U.S. Territory). For purposes of clarity, Product Development shall include the right (i) to use the clinical data generated in such clinical studies to seek additional Regulatory Approvals for a Product and engage in associated regulatory activities and (ii) to develop new indications for a Product with the same formulation and dosage form and to develop additional support for the Product generally.
Product Development means all actions reasonably necessary in connection with seeking and obtaining Governmental Approval of the Licensed Product in the Territory, including, if and as necessary, the performance of clinical trials of the Licensed Product in the Territory in accordance with this Agreement.
Product Development means the research (other than preclinical or clinical Product Testing), clinical or preclinical development, design and/or enhancement of devices.
Examples of Product Development in a sentence
Customer hereby authorizes BD to access and use such Healthcare Data, separately or aggregated with other data: (i) to provide Products, Support, Service, Remote Support Service, Updates, and Implementation Services under the Customer Order/Product Addendum; (ii) for Product Development to improve the delivery, quality, or safety of healthcare; (iii) for Evidence Generation; and, (iv) for Customer Needs Identification.
More Definitions of Product Development
Product Development means for purposes of this Agreement all toxicology, pharmacology, safety, animal efficacy and preclinical studies (other than those preclinical studies included under the Research), clinical trials, regulatory affairs and all other activities reasonably required to obtain all governmental approvals required to market a Product within the Field in the Major Countries.
Product Development means the development, design and/or enhancement of devices.
Product Development means investigations directed toward the establishment of methods of manufacture or of specific designs of salable substances, devices, or procedures, based on previously discovered facts, scientific principles or substances.
Product Development means (i) the work conducted primarily with the ------------------- intent and for the purpose of formulating, and the entire development process with respect to, a Licensed Product or Licensed Compound for use in a Licensed Process, including the methods validation, the acquisition or synthesis of raw materials, pharmacological tests and other activities in connection with the manufacture and production of clinical trial material and finished pharmaceutical dosages in commercial quantities, (ii) the preparation and compilation of all the required data and information in a format appropriate and ready for submission as "Chemistry, Manufacture and Control" data to the FDA, (iii) document preparation and (iv) all other things customarily done in the product development of pharmaceuticals by the holder of the exclusive right to manufacture and market the subject pharmaceutical, excluding the payment of Third Party Royalties and the work covered by Patent Costs.
Product Development means Arius’ use of commercially reasonable efforts to take, at its sole cost and expense or together with a strategic partner or sublicensee, all actions reasonably necessary in connection with the development of a Product including but not limited to (a) any formulation, chemistry, toxicology, or other research and development activities reasonably related to the development of a Product, (b) all preclinical and clinical studies, including Phase I, Phase II, Phase III, and/or, if and as appropriate, Phase IV studies, and (c) preparation, organization, and filing of regulatory documents.
Product Development refers to product development carried out in the area of one side for the purposes of producing or processing the exporting goods. Development expenses incurred should be related to the exporting goods. These expenses include fees payable for the development of designs, patents, patented technologies, trademarks or copyrights (collectively "these rights") carried out by the manufacturer himself, fees payable to a natural or legal person in the area of one side for undertaking development of these rights, and fees payable for purchasing these rights owned by a natural or legal person in the area of one side. The fees payable should be clearly identifiable under generally accepted accounting principles and the requirements of “Agreement on Implementation of Article VII of the General Agreement on Tariffs and Trade 1994”;
Product Development means the preclinical and clinical development program on a PRODUCT within the FIELD conducted during the term of this CDA or any extensions thereof under Section 9.01 primarily with the intent and purpose of generating data for submission to a regulatory authority in the TAISHO TERRITORY, in the case of TAISHO, and in the IDEC TERRITORY, in the case of IDEC, in support of an application for governmental approval required for commercializing PRODUCT for any indication. Such