Distinct Formulation definition

Distinct Formulation means a formulation of the Compound that is not an Interchangeable Formulation.
Sample 1

Examples of Distinct Formulation in a sentence

  • If the Proposed Outside Field License pertains to a Distinct Formulation and such does not ultimately fall under Subsection 2.6.2., and if the parties do not either timely execute a ROFN Term Sheet or TILLOTTS does not accept the ROFR Notice within the ROFR Acceptance Period, if applicable, or a license agreement with regard to the Proposed Outside Field License, then CPP will be free to grant to third parties the Proposed Outside Field License that was the subject of the ROFN Notice.

  • CPP may develop and commercialize any Distinct Formulation for Pediatric Cancers in the Licensed Territory with no obligations to TILLOTTS.

Related to Distinct 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;

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

  • ingredient means any substance, including a food additive used in the manufacture or preparation of food and present in the final product, possibly in a modified form;

  • 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.

  • Interchangeable biological product means a biological product that the U.S. Food and Drug Administration has:

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

  • 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.

  • 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.

  • Biomarker means a parameter or characteristic in a patient or Patient Sample, the measurement of which is useful (a) for purposes of selecting appropriate therapies or patient populations or monitoring disease susceptibility, severity or state, or monitoring therapies for such patient and/or (b) for predicting the outcome of a particular treatment of such patient.

  • Companion Diagnostic means a device which is essential for the safe and effective use of a corresponding medicinal product to:

  • labelling means any words, particulars, trade marks, brand name, pictorial matter or symbol relating to a food and placed on any packaging, document, notice, label, ring or collar accompanying or referring to such food;

  • Cyanoacrylate adhesive means any adhesive with a cyanoacrylate content of at least 95% by weight.

  • Licensed Compound means [***].

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

  • Biological agent shall mean any pathogenic (disease producing) micro-organism(s) and/or biologically produced toxin(s) (including genetically modified organisms and chemically synthesized toxins) which cause illness and/or death in humans, animals or plants.

  • Reference biological product means the single biological product licensed pursuant to 42 U.S.C.

  • Assay means a laboratory analysis of Crude Petroleum to include the following: A.P.I. Gravity, Reid vapor pressure, composition, pour point, water and sediment content, sulfur content, viscosity, distillation, hydrogen sulfide, flash/boiling point and other characteristics as may be required by Carrier.

  • Licensed Compounds means any EZH2 Compound(s) that is:

  • Polystyrene foam adhesive means an aerosol adhesive designed to bond polystyrene foam to substrates.

  • Dose is a generic term that means absorbed dose, dose equivalent, effective dose equivalent, committed dose equivalent, committed effective dose equivalent, total organ dose equivalent, or total effective dose equivalent. For purposes of these regulations, "radiation dose" is an equivalent term.

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

  • Combination Products means any product containing both a pharmaceutically active agent or ingredient which constitutes a Licensed Product and one or more other pharmaceutically active agents or ingredients which do not constitute Licensed Products.

  • Combination Product means any product that comprises a Licensed Compound or Licensed Product sold in conjunction with another active component so as to be a combination product (whether packaged together or in the same therapeutic formulation).

  • Antibody means a molecule or a gene encoding such a molecule comprising or containing one or more immunoglobulin variable domains or parts of such domains or any existing or future fragments, variants, modifications or derivatives thereof.

  • Active Pharmaceutical Ingredient or “API” means the active pharmaceutical substance of the Drug in bulk form prior to incorporation into the Product.

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