Existing Formulation definition

Existing Formulation means the formulation of the Product with Regulatory Approval from the FDA as of the Execution Date.
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Existing Formulation means any Cream Formulation for Compound or Product that is claimed or covered by an Existing Patent or a Patent that claims priority thereto or shares a priority claim therewith.
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Existing Formulation has the meaning ascribed thereto in Section 3.1(b)(iv).
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Examples of Existing Formulation in a sentence

  • As of the Effective Date, ABARIS expects that the Phase III Clinical Study related to the Existing Formulation will begin during the third quarter of the year 2004.

  • PARI acknowledges that: (a) the development, manufacture, verification and delivery of the Test Inhalers according to the Test Inhaler Delivery Schedule is critical to the Phase II Clinical Study for the Existing Formulation; and (b) in setting the Test Inhaler Delivery Schedule, ABARIS has taken into account certain risks, some of which cannot be fully foreseen as of the Effective Date.

  • ABARIS shall be responsible for pursuing regulatory approval for the Existing Formulation.

  • Nothing in this Agreement shall prevent, restrict or limit ABARIS from developing and commercializing the Existing Formulation or such Drug Product apart from PARI, and PARI shall not acquire any interest or have any claim to the Existing Formulation or such Drug Product by virtue of this Agreement.

  • The Parties shall not implement the Program A Commercialization Strategy until ABARIS determines that the results of the Phase III Clinical Study related to the Existing Formulation are positive.

  • During the year the Company conducted a pro-rata non-renounceable entitlements issue (“Entitlements Issue” or “the Issue”) to existing shareholders to raise approximately A$1.45 million (before costs of issue).

  • Licensee shall pay to Verastem the non-refundable, non-creditable milestone payments set forth in Table 7.2 below (each, a “Regulatory Milestone Payment”) upon the first achievement by Licensee or its Affiliates or Sublicensees of the corresponding regulatory milestone events set forth in Table 7.2 below (each a “Regulatory Milestone Event”) for an Existing Formulation Product [* * *].

  • In the event that ABARIS conducts a Phase III Clinical Study related to the Existing Formulation of the Drug Product, the Parties shall discuss and develop a written Program A Commercialization Strategy for the commercialization of the Drug Product made using the Existing Formulation and the Inhaler adapted to deliver such Drug Product.

  • Positioned within the 130 and 150 OLS contour, the proposal isreferred to the Department of Transport and Main Roads (DTMR) due to the encroachment into the airport operational airspace.

  • PARI acknowledges that ABARIS has the right to proceed with the development and commercialization of the Novel Formulation instead of the Existing Formulation, and that in such case, ABARIS shall not be in breach of the Agreement for its failure to develop, test, pursue regulatory approval for or make any commercial sales of the Drug Product produced with the Existing Formulation.


More Definitions of Existing Formulation

Existing Formulation means the one or more formulations for the Drug Product which are known or otherwise exist as of the Effective Date, including, without limitation, compositions, chemical structures, molecules, compounds, ingredients, formulas, recipes, chemical reactions, mixtures, technical information and know-how of the Drug Product which are necessary for producing, manufacturing or packaging the Drug Product.
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Related to Existing Formulation

  • Existing Product means any formulation of the same product category and form sold, supplied, manufactured, or offered for sale in California prior to the following dates, or any subsequently introduced identical 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;

  • Existing Products Tangible Products and intangible licensed Products that exist prior to the commencement of work under the contract. Existing Products must be identified on the Product prior to commencement of work or else will be presumed to be Custom Products.

  • Product means any deliverable under the Contract, which may include commodities, services, technology or software.

  • Replacement Product means electric generating capacity, capacity-related benefits, environmental attributes, Energy or other electric products from a generation resource other than the Facility that are provided or delivered to replace or substitute for Contract Capacity or Storage Capacity (or any Capacity-Related Benefit, Environmental Attribute, Other Electric Product, Contract Energy, or Storage Energy associated therewith), in each case, in whole or in part, pursuant to Section 4.6.

  • Defective Product has the meaning set forth in Section 5.2.

  • 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”).

  • New Products means any product which is not an Enhanced Product or Existing Product but which is substantially similar to an of this Agreement, "New Product" or "New Products" shall mean 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.

  • Tobacco product manufacturer means an entity that after the date of enactment of this act directly (and not exclusively through any affiliate) meets 1 or more of the following:

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

  • Aerosol Product means a pressurized spray system that dispenses product ingredients by means of a propellant contained in a product or a product's container, or by means of a mechanically induced force. “Aerosol Product” does not include “Pump Spray.”

  • MSAA Indicator Technical Specifications document means, as the context requires, either or both of the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Indicator Technical Specifications November 5, 2018 Version 1.3” and the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Target and Corridor-Setting Guidelines” as they may be amended or replaced from time to time;

  • 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.

  • 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.

  • Hemp products means all products made from industrial hemp,

  • 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.

  • Aerosol coating product means a pressurized coating product containing pigments or resins that dispenses product ingredients by means of a propellant, and is packaged in a disposable can for hand-held application, or for use in specialized equipment for ground traffic/marking applications.

  • Cannabis products means cannabis that has undergone a process whereby the plant material has been transformed into a concentrate, including, but not limited to, concentrated cannabis, or an edible or topical product containing cannabis or concentrated cannabis and other ingredients.

  • 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;

  • Product Manufacturer means the entity that assembles the component parts to manufacture the final Product;

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

  • Remanufacturing means the activity of overhauling, retrofitting, fabricating, or repairing a product or its component parts for ultimate sale at retail.

  • Product Candidate means each biological and drug candidate, compound or other device or product being developed, labeled, manufactured, marketed, sold and/or distributed by the Company or a Company Subsidiary, or regarding which the Company or a Company has rights, and including any such biological and drug candidate, compound or product that has received Marketing Approval.

  • Products means information resources technologies that are, or are related to, EIR.

  • Nicotine product means the same as that term is defined in Section 76-10-101.