Dosage Form Development definition

Dosage Form Development means any pharmaceutical development activities for the Product that are necessary to design or modify a pharmaceutical formulation or dosage form to meet the desired clinical or commercial product profile, including in vitro studies on solubility, stability, physical and chemical characteristics, denaturation, particle formation, crystallization, micronization, excipient/material selection, compounding, mixing, casting, converting, drying, and similar activities.
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Dosage Form Development means any pharmaceutical development activities for the Product undertaken in order to design or modify a pharmaceutical formulation or dosage form to meet the desired clinical or commercial product profile, including in vitro studies on solubility, stability, physical and chemical characteristics, denaturation, particle formation, particle aggregation and settling, crystallization, micronization, excipient/material selection, compounding, mixing, casting, converting, drying, and similar activities. Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
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Dosage Form Development shall have the meaning given in Section 3.1.
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Examples of Dosage Form Development in a sentence

  • Can-F▇▇▇ will invite SKK’s input on Dosage Form Development, and will use good faith efforts to meet the needs of SKK in this regard, but Can-F▇▇▇ shall have final decision-making authority regarding the tablet dosage form of the Product to be used outside of the Territory.

  • Notwithstanding anything to the contrary in this Agreement, in no event shall Codexis be obligated to [***] in conducting the Solid Dosage Form Development Study.

  • Endo shall exercise Commercially Reasonable Efforts to develop the Product at its own cost in accordance with the Development Plan, except that, subject to the terms of this Agreement, Durect shall perform: (i) all Dosage Form Development with respect to the Product and (ii) any other development activity allocated to Durect by Endo and agreed to by Durect, in either case in accordance with the Development Plan.

  • The results of Dosage Form Development shall be disclosed to SKK promptly after completion of Dosage Form Development in writing and incorporated into the Licensed Technology or Data respectively.

  • The Development Plan attached hereto as Exhibit A sets forth the details of the Development activities to be undertaken by Codexis pursuant hereto through the date of the Option Trigger and, thereafter in respect of the Solid Dosage Form Development Study, to the extent such Solid Dosage Form Development Study is not completed prior to the date of the Option Trigger.

  • Commencing on the Commencement Date (as defined below) the Company shall employ the Employee for the Term (as herein defined), to render exclusive and full-time paid services (as herein defined) as the Company's Vice President of Modified Release Dosage Form Development.

  • Notwithstanding anything to the contrary herein, Codexis shall [***] the Solid Dosage Form Development Study [***] that is [***] after the Effective Date.


More Definitions of Dosage Form Development

Dosage Form Development means any pharmaceutical development activities for the Product undertaken in order to design or modify a pharmaceutical formulation or dosage form to meet the desired clinical or commercial product profile, including in vitro studies on solubility, stability, physical and chemical characteristics, denaturation, particle formation, particle aggregation and settling, crystallization, micronization, excipient/material selection, compounding, mixing, casting, converting, drying, and similar activities. *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
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Dosage Form Development means any pharmaceutical development activities for the Product undertaken in order to design or modify a pharmaceutical formulation or dosage form to meet the desired clinical or commercial product profile, including in vitro studies on solubility, stability, physical and chemical characteristics, denaturation, particle formation, particle aggregation and settling, crystallization, micronization, excipient/material selection, compounding, mixing, casting, converting, drying, and similar activities.
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Dosage Form Development means any work relating to the formulation or composition of the Product. Endo shall pay Durect its documented, fully allocated development costs in connection with the performance of work under the Development Plan on a monthly basis, Net 30 days from the receipt of a correct invoice therefor from Durect; provided that Endo shall have no obligation to reimburse Durect’s costs in excess of the amount specified in the then-current Development Plan, and Durect shall have no obligation to perform activities which would result in Durect incurring costs in excess of the amount specified in then-current Development Plan until Endo has given prior approval in writing to increase the allowable amount for such activities under the Development Plan.
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Related to Dosage Form Development

  • 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.

  • Clinical Development means the conduct of clinical trials in humans to assess the dosing, safety and/or efficacy of the Product, including but not limited to Phase I Clinical Trials, Phase II Clinical Trials, Phase Ill Clinical Trials and Phase IV Clinical Trials.

  • Therapeutic diet means meals served that are soft, low-fat, low-sodium or controlled calorie.

  • Therapeutic school means a residential group living facility:

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;