Prototype Formulation definition

Prototype Formulation means a Formulation of a Compound prepared in accordance with a Work Plan to evaluate a dosage form comprising a cartridge containing a dry powder Formulation of a Compound, which cartridge would be inserted into, or contained within, a pulmonary delivery device (including a Device) for administration in vivo.
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Examples of Prototype Formulation in a sentence

  • In the event that the results of the Pre-Pivotal Study are unsatisfactory in that it is not fully demonstrated to the good faith mutual satisfaction of the Parties that at least one of the Prototype Formulations meet the respective Specifications, KRYPTON may elect to abandon the development program and terminate this Agreement with respect to such Prototype Formulation by giving written notice to that effect to GENTA JAGO.

  • Upon mutual agreement of the Prototype Formulation to be used for development as referred to in Section 6.5 above, GENTA JAGO shall be responsible for and initiate the technology transfer to, and perform the scale-up at, the manufacturing site mutually established and agreed upon by the Parties.

  • Except as expressly set forth in this Agreement, MannKind makes no representations nor extends any warranties of any kind, either express or implied, and expressly disclaims all implied warranties of merchantability and of fitness for a particular purpose or use, non-infringement, validity and enforceability of patents, or the prospects or likelihood of development or commercial success of the Prototype Formulation.

  • MannKind represents and warrants to United Therapeutics that it has and shall at all times throughout the term of this Agreement maintain, whether by ownership, by license or otherwise, the Intellectual Property Rights that are required to use, manufacture, market, offer to sell, sell, import and export the Prototype Formulation.

  • This Agreement does not convey any ownership or other rights in any Prototype Formulation or MannKind Intellectual Property Rights embodied therein by implication, estoppel or otherwise except for the rights expressly granted in Article 4.

  • MannKind shall retain ownership and control of the Prototype Formulation and all of ▇▇▇▇▇▇▇▇’s Intellectual Property Rights therein that were in existence as of the Effective Date or are later generated by ▇▇▇▇▇▇▇▇ whether inside or outside of scope of the performance by MannKind of its obligations under this Agreement.

  • MannKind shall retain ownership and control of the Prototype Formulation and all of MannKind’s Intellectual Property Rights therein that were in existence as of the Effective Date or are later generated by MannKind whether inside or outside of scope of the performance by MannKind of its obligations under this Agreement.

Related to Prototype Formulation

  • Formulation means the combination of various ingredients designed to render the product useful and effective for the purpose claimed, or the form of pesticide as purchased by users;

  • Prototype means a first model or design that has not been produced in batches, and from which the finished cosmetic product is copied or finally developed.

  • Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood

  • Manufacturing Process means any process for—

  • Manufacturing means all activities directed to sourcing of necessary raw materials, producing, processing, packaging, labeling, quality assurance testing, release of a Licensed Product or Licensed Product candidate, whether for Development or Commercialization. When used as a verb, “Manufacture” means to engage in Manufacturing.