Pediatric Product definition

Pediatric Product means the pharmaceutical presentation of the Compound (a) that utilizes or incorporates PULSYS™, (b) that contains no active pharmaceutical ingredient (including any active pharmaceutical ingredient that acts as a [***]) other than the Compound, and (c) that is used or is being developed for the Pediatric Product Indications, other than formulations of Exhibit A.
Sample 1
Pediatric Product means any product containing the Compound for any pediatric indication, that is developed pursuant to this Agreement, and is not the WH Product in the WH Field or Oncology Product in the Oncology Field existing as of the Effective Date.
Sample 1
Pediatric Product means the pharmaceutical presentation of the Compound (a) that utilizes or incorporates PULSYS(TM), (b) that contains no active pharmaceutical ingredient (including any active pharmaceutical ingredient that acts as a [***]) other than the Compound, and (c) that is used or is being developed for the Pediatric Product Indications, other than formulations of Exhibit A.
Sample 1

Examples of Pediatric Product in a sentence

  • The case will go back to the Planning Commission to be revisited.Attorney Tim Gulden informed the Board of Trustees that the Ordinance 130 was approved in 2014 by but it didn’t get published in a timely fashion so it needs to be adopted again so that it can be published and enacted.

  • His past experience is as a Technical Trainer at JCM seating in the UK, Pediatric Product Specialist for Hewerdines in the UK, working with a children’s charity.

  • Novavax shall submit its application for Regulatory Approval in Canada, for each of Product, Variant Product, and/or Pediatric Product, no later than [***] of its first submission for Regulatory Approval of that Product, Variant Product and/or Pediatric Product in another priority market (such as the United States of America or the European Union).

  • Pediatric Product Sales, Marketing and Development.......................................45 SECTION 6.14.

  • Meiji Seika and Cornerstone discussed the mechanism and allocation of expenses for the remaining part of the development of the Once-Daily Product and the Pediatric Product.

  • In accordance with Section 3.3, GSK shall devote Diligent Efforts to clinically and regulatorily develop and seek Regulatory Approval for the Current Product and the Current Pediatric Product (beginning at the time that GSK's diligence obligations with respect to the Current Pediatric Product become effective pursuant to such Section) for Licensed Indications [ * ] undertaking shall include carrying out the GSK Development Plan (as updated pursuant to Section 3.3).

  • The targeted inventory of each Pediatric Product shall be nine (9) weeks of inventory for such Pediatric Product, and any amount of inventory of a Pediatric Product in excess of such amount shall be “Surplus Inventory” and any deficit of inventory of such Pediatric Product will be deemed “Deficit Inventory”.

  • They suggested that a forum for timely and aligned pediatric testing advice from FDA and EMA would significantly facilitate efficient pediatric drug development.‌ 1.11 Necessary Advances in Pediatric Product Development and Use Stakeholders raised concerns regarding the challenges associated with pediatric drug development for neonates, including the lack of scientific understanding regarding endpoints and biomarkers and the lack of natural history information for diseases in the neonatal population.

  • As part of the sale of the Pediatric Product Portfolio, the Deerfield Obligation was assumed by Aytu.

  • To the extent set forth in Section 5.1, GSK shall devote Diligent Efforts to Commercialize the Current Product and the Current Pediatric Product for Licensed Indications in the GSK Territory.


More Definitions of Pediatric Product

Pediatric Product means, as the case may be, (a) a pharmaceutical presentation of the Amox-Only Compound (a)(i) that utilizes or incorporates PULSYSÔ, (b)(ii) that contains no active pharmaceutical ingredient (including any active pharmaceutical ingredient that acts as a [***]) other than the Amox-Only Compound, and (c) (iii) that is used or is being developed for the Pediatric Product Indications, [***]; and/or (b) the pharmaceutical presentation of the Amox-Clav Compound (i) that utilizes or incorporates PULSYSÔ, [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 UNDER THE SECURITIES AND EXCHANGE ACT OF 1934, AS AMENDED. that contains no active pharmaceutical ingredient other than the Amox-Clav Compound, and (iii) that is used or is being developed for the Pediatric Product Indication [***] other than formulations of Exhibit A.
Sample 1
Pediatric Product means, as the case may be, (a) a pharmaceutical presentation of the Amox-Only Compound (a)(i) that utilizes or incorporates PULSYSÔ, (b)(ii) that contains no active pharmaceutical ingredient (including any active pharmaceutical ingredient that acts as a [***]) other than the Amox-Only Compound, and (c)(iii) that is used or is being developed for the Pediatric Product Indications, [***]; and/or (b) the pharmaceutical presentation of the Amox-Clav Compound (i) that utilizes or incorporates PULSYSÔ, that contains no active pharmaceutical ingredient other than the Amox-Clav Compound, and (iii) that is used or is being developed for the Pediatric Product Indication [***] other than formulations of Exhibit A. 8.
Sample 1
Pediatric Product means the vitamin-related pharmaceutical product marketed and sold under the unregistered trademark "MVI-Pediatric".
Sample 1
Pediatric Product has the meaning set forth in Section 2.24(b).
Sample 1
Pediatric Product means a pediatric form of the Product.
Sample 1

Related to Pediatric Product

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

  • Licensed Product means a product, method or service in the Licensed Field of Use, the making, having made, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent.

  • Medical marijuana product means a product that contains cannabinoids that have been extracted from plant material or the resin therefrom by physical or chemical means and is intended for administration to a licensed patient, including but not limited to concentrates, oils, tinctures, edibles, pills, topical forms, gels, creams, and other derivative forms, except that this term does not include live plant forms.

  • 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.

  • Marijuana product means marijuana as defined in 50-32-101 and marijuana-infused products

  • 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;

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

  • Therapeutic school means a residential group living facility:

  • Generic Product means any pharmaceutical product that (i) is sold by a Third Party that is not an Affiliate or licensee of Buyer and (ii) (a) contains the same active pharmaceutical ingredient as the Product or (b) is categorized by the applicable Governmental Entity in a country to be therapeutically equivalent to, or interchangeable with, the Product, such that the pharmaceutical product may be substituted for the Product at the point of dispensing without any intervention by the prescribing physician in such country.

  • Pre-Licensed Therapist means an individual who has obtained a Master’s Degree in Social Work or Marriage and Family Therapy and is registered with the BBS as an Associate CSW or MFT Intern acquiring hours for licensing. An individual’s registration is subject to regulations adopted by the BBS.

  • Tobacco product means any substance containing tobacco leaf, including but not limited to, cigarettes, cigars, pipe tobacco, hookah tobacco, snuff, chewing tobacco, dipping tobacco, bidis, blunts, clove cigarettes, or any other preparation of tobacco; and any product or formulation of matter containing biologically active amounts of nicotine that is manufactured, sold, offered for sale, or otherwise distributed with the expectation that the product or matter will be introduced into the human body by inhalation; but does not include any cessation product specifically approved by the U.S. Food and Drug Administration for use in treating nicotine or tobacco dependence.

  • Marihuana-infused product means a topical formulation, tincture, beverage, edible substance, or similar product containing marihuana and other ingredients and that is intended for human consumption.

  • Cannabis product 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.

  • 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.

  • WTO GPA country end product means an article that—

  • Anti-Static Product means a product that is labeled to eliminate, prevent, or inhibit the accumulation of static electricity. “Anti-Static Product” does not include “Electronic Cleaner,” “Floor Polish or Wax,” “Floor Coating,” and products that meet the definition of “Aerosol Coating Product” or “Architectural Coating.”

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

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • Licensed Programs means, collectively, NeoSystems’ and any Third Party Vendor computer software programs to be provided to Client for use on certain hardware on Client’s premises or a third party’s premises as set forth in an Agreement. The Licensed Programs shall include any fixes, work-arounds, updates, revisions, modifications, enhancements and any derivative works that are provided to Client by NeoSystems under an Agreement.

  • 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.

  • 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.

  • Licensed Compound means [***].

  • Licensed Program means the executable processing programs of licensed information, which is composed of various modules in the Licensed Software package provided by the Licensor.

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.