New Formulation definition

New Formulation means any Licensed Product that has not been approved for use in the Field as of the Effective Date.
Sample 1Sample 2Sample 3
New Formulation means a formulation of Cimzia® as the sole active ingredient other than the Current Formulation.
Sample 1Sample 2Sample 3
New Formulation means the Licensed Product for the Initial Indication in any formulation other than the Initial Formulation, and with respect to which either Otsuka or Acucela makes a proposal to the JDC to Develop as provided in Section 3.3.
Sample 1Sample 2Sample 3

Examples of New Formulation in a sentence

  • Notwithstanding the foregoing provisions of this definition, the term “Licensee Know-How” shall not include Ipsen Licensed Know-How, Ipsen New Formulation Know-How and Joint Know-How.

  • How shall mean all Know-How that is included within Ipsen New Formulation Technology.

  • With its pipeline filled with New Formulation drugs, Taiwan Liposome Company is well positioned to take advantage of the trend.

  • AbbVie will have ninety (90) days from the date of notification to AbbVie of a New Formulation containing other compounds in which it may provide notice of its intent to exercise the option provided in this section, failing which the option(s) will have been deemed to be declined.

  • In the event that Licensee develops a new formulation or dosage form of a License Product that requires clinical studies for regulatory approval or [*] (a “New Formulation or Use”), Licensee shall pay royalties to GenuPro on such New Formulation or Use at the same rate as set forth in Section 5.03 hereof, provided that the amount of royalties otherwise due under this Section 5.08(c) will not be paid until Licensee [*].

  • Under the Clinical Supply Agreement, Ipsen will manufacture or have manufactured and tested the bulk product and devices applicable to the New Formulation Licensed Product for phase II clinical trials, and will provide the analytical control data, with suitable documentation from contract manufacturing company, and Radius will complete final clinical packaging/labeling, and final Quality Assurance release of the clinical supplies of New Formulation Licensed Product for phase II clinical trials.

  • All terms of such Clinical Supply Agreement apply to the supply by Ipsen to Radius of New Formulation Licensed Product for phase II clinical trials to the exception of the Technical Specifications, Manufacturing and Analytical Procedure and Safety Agreement and the price for the clinical supplies and work associated and quantities of clinical batches.

  • The supply of New Formulation Licensed Product by Ipsen to Radius for use in phase II clinical trials will be managed under the terms agreed in Appendix D of the License Agreement dated September 27 2005 “Clinical Supply and Technical Transfer Agreement BIM 44058 injection clinical supplies and technology transfer” (hereinafter the “Clinical Supply Agreement”).

  • From time to time during the term of this Agreement or upon the reasonable request of Radius, Ipsen shall supply Radius with reasonable quantities of compounds generated or formulated by Ipsen in the course of performing its research tasks and activities under the Work Plan for purposes of enabling Radius to test such compounds and the formulation thereof and for purposes of allowing Radius to assess the extent to which such compounds meet the specifications for a New Formulation Licensed Product.

  • In the event that such New Formulation contains compounds also under license to Licensee from a third party that contains non-exclusive grant-back obligations, the parties will confer regarding commercialization rights outside the Territory.


More Definitions of New Formulation

New Formulation means any formulation (including dosage form or dosage amount) of a Product other than an Initial Formulation.
Sample 1Sample 2
New Formulation means any formulation of Product other than the Tablet Formulation. For clarity, any Combination Product shall be a New Formulation.
Sample 1Sample 2
New Formulation means any formulations which contain the Technology as an active ingredient, other than the IR Formulation or the SR Formulation.
Sample 1Sample 2
New Formulation means any pharmaceutical product containing bendamustine HCl (alone or with other active ingredients) that is an improvement, enhancement, upgrade or modification to one or both of the RTD Product or the RI Product, in any presentation, dosage form or strength, form of administration, formulation or dosing regimen; provided, however, such dosage form, strength, form of administration, or regimen requires a separate Regulatory Approval.
Sample 1
New Formulation means any formulation of a Licensed Product other than the Tablet Formulation or any other formulation of a Licensed Product used for any clinical or non-clinical study set forth on Schedule 1.27.
Sample 1
New Formulation means [REDACTED: Description of new formulation]
Sample 1

Related to New 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;

  • Pharmaceutical Product shall have the meaning ascribed to such term in Section 3.1(hh).

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether

  • Therapeutic Product means a health product categorised as a therapeutic product in the First Schedule to the Act;

  • Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein other than a chemically synthesized polypeptide, or analogous product, or arsphenamine or any derivative of arsphenamine or any other trivalent organic arsenic compound, applicable to the prevention, treatment, or cure of a disease or condition of human beings.

  • New Product means the Synology-branded hardware product and Synology-branded accessories contained in the original packaging Customer bought from an authorized Synology distributor or reseller. You may see our “New Product” at Product Support Status.

  • 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.

  • 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;

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

  • 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.

  • Manufacturing Process means any process for—

  • Hemp product means the same as that term is defined in § 3.2-4112.

  • Licensed Product means a product or part of a product in the Licensed Field of Use: (A) the making, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent; or (B) which is made with, uses or incorporates any Technology.

  • Additional Product means any Product identified as such in the Product Terms and chosen by Enrolled Affiliate under this Enrollment.

  • Diagnostic Product means any test or assay for diagnosing or detecting a disease, disorder, medical condition, or symptom.

  • Licensed Compound means [***].

  • Commercializing means to engage in Commercialization and “Commercialized” has a corresponding meaning.

  • Final Product means a reasonably homogenous cannabis product in its final packaged form created using the same standard operating procedures and the same formulation.

  • New Products means any product which is not an Enhanced Product or 2 Existing Product but which is substantially similar to an Existing Product with respect to design and function and possesses reasonable performance improvements. If Company desires to purchase an Enhanced or New Product(s) from Supplier, Company shall so notify Supplier and provide Supplier the opportunity to manufacture such Enhanced or New Product(s), subject to the following conditions and procedures.

  • Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).

  • Licensed Compounds means: (a) Research Program Active Compounds; (b) Novartis Active Compounds; (c) salts, hydrates, solvates, esters, metabolites, intermediates, stereoisomers and polymorphs of Research Program Active Compounds or Novartis Active Compounds; and (d) prodrugs of Research Program Active Compounds or Novartis Active Compounds (any of the foregoing, a “Licensed Compound”).

  • Active Pharmaceutical Ingredient or “API” shall mean one or more of the following active pharmaceutical ingredients: tenofovir alafenamide (“TAF”), tenofovir disoproxil fumarate (“TDF”), elvitegravir (“EVG”), and cobicistat (“COBI”).

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Nicotine product means a product that contains nicotine and is not any of the following:

  • Biological Samples means any physical samples obtained from Study Participants in accordance with the Protocol for the purposes of the Study.

  • Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.