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 has the meaning ascribed thereto in Section 3.1(b)(iv).
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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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Examples of Existing Formulation in a sentence

  • Each report shall also identify the date of First Commercial Sale of an Existing Formulation Product in each country in the Territory.

  • 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.

  • For the purposes of clarity, ABARIS shall not owe any royalty payments due under Section 3.11 for any sales of Drug Products for use with the Inhaler, where the Existing Formulation is used to produce such Drug Products, which shall instead be governed by Section 2.18.

  • For clarity, except as provided in Section 2.22.2(d) below, PARI shall not acquire or claim any right, title or interest in the Intellectual Property relating to the Existing Formulation.

  • In no event shall any such announcement or release disclose any description of the novel, proprietary or technical aspects of this Agreement, the Development Activities, the results thereof, or the functional design, elements or components of the Existing Formulation, Novel Formulation, Drug Product, Test Inhaler or Inhaler without the prior written consent of the other Party.

  • Subject to the Program A Commercialization Strategy and the Program B Commercialization Strategy, PARI will sell to ABARIS, its Affiliates, its Sublicensees, its designees or other parties: (a) Inhalers adapted to deliver Drug Product made using the Existing Formulation; and/or (b) Inhalers adapted to deliver Drug Product made using the Novel Formulation.

  • In such event, upon the request of either Party, the Parties shall negotiate in good faith an amendment to this Agreement to allow PARI to continue certain development activities for ABARIS’ Phase III Clinical Study related to the Existing Formulation.

  • Within [* * *], commencing with [* * *], Licensee shall provide Verastem with a report that contains the following information for the applicable [* * *], on an Existing Formulation Product-by-Existing Formulation Product and country-by-country basis: [* * *].

  • Agenda No. 10.2 Proposed Pesticide Technical (150 MT/Month) and Specialty Chemical (100 MT/Month) in Existing Formulation Unit (4000 MT/Month) by M/s Niyam Industries, located at District Bharuch, Gujarat- Consideration of Environment Clearance [IA/GJ/IND3/208650/2020; IA-J-11011/162/2021-IA-II(I) The Project Proponent and the accredited Consultant M/s Aqua-Air Environmental Engineers Pvt.

  • PARI acknowledges that ABARIS has the right to proceed with the development and commercialization of the Existing Formulation instead of the Novel 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 Novel 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 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):

  • 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 related to the manufacture of a Compound, including planning, purchasing, manufacture, processing, compounding, storage, filling, packaging, waste disposal, labeling, leafleting, testing, quality assurance, sample retention, stability testing, release, dispatch and supply, as applicable.

  • 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 any pharmaceutical product developed, manufactured and/or tested by or on behalf of the Company that has not received a Regulatory Authorization for commercial distribution other than in connection with pre-clinical or clinical trials.

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

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