Product Development definition

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 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.

Examples of Product Development in a sentence

• Product Development Grant The funds under the grant-in-aid limited to the extent sanctioned shall be transferred to the SPARK Grantee in 5 tranches - 10%, 20%, 30%, 30% and 10% tranche or subject to compliance of proviso to Clause 1.16, as per Annexure C, each tranche linked to a milestone designated by goals and deliverables for each milestone as per the WBS, which is proposed by the SPARK Grantee and approved thereof by the DIO.

• Annexure C Statement of Provisional Product Development Budget & Matching Contribution I, Amit Xxxx Xxxx, hereby accept that the total expenditure incurred during the process of product development shall not exceed the amount of Rs. 2,00,00,000 (Rs. Two Crores), as has been approved by DIO.

• PDB at the time of signing of the agreement is tentative which may undergo multiple changes during the course of Product Development.

• Product Development SPARK Grantee shall employ adequate resources and significant efforts required to complete product development using standard product development lifecycle methods and practices as is commonly followed in the industry.

• Format of Product Development Completion report is included as Xxxxxxxx X.

More Definitions of Product Development

Product Development means the development, design and/or enhancement of devices.

Product Development means the research (other than preclinical or clinical Product Testing), clinical or preclinical development, design and/or enhancement of devices.

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 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 the process, in general, encompassing all technical, commercial, financial, managerial, and administrative activities as is duly required for developing a technologically advanced solution, carried out by the SPARK Grantee independently and/or in consultation with its partners defined in the broadest sense, and/or in consultation with the PMU of DIO and the designated PI.

Product Development. Both PARTIES agree to use best efforts to develop, design and manufacture such new products as required to meet NSC customer requests. QUALIFICATION: See Attachment IV.

Product Development. Plan shall have the meaning set out in Section 3.2.1(d).