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, 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 a pediatric form of the Product.
Sample 1

Examples of Pediatric Product in a sentence

  • Additional pediatric information and contact information is available on the Pediatric Product Development web page.175 171 See section 505A(i)(1) of the FD&C Act (21 U.S.C. 355a(i)(1)).

  • In the case of Surplus Inventory as to a Pediatric Product, the amount calculated pursuant to the preceding sentence shall reduce the total Gross Profits otherwise calculated for purposes of Sections 1 and 2 above.

  • 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.

  • The Development activities with respect to the Pediatric Product in the Pediatric Field in the Co-Promotion Territory are set out in the initial WH Joint Medical Affairs and Development Plan and Budget.

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

  • 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).

  • To the extent that Myovant is responsible for the Manufacture of the preclinical and clinical supply of Compound, the Oncology Product(s) or Pediatric Product, or the commercial supply of Compound, the Oncology Product(s) in the Oncology Field or Pediatric Product in the Pediatric Field in the Pfizer Territory for Pfizer, such supply shall be pursuant to separate supply agreement between Myovant and Pfizer (the “Supply Agreement”).

  • In the case of Deficit Inventory as to a Pediatric Product, the amount calculated pursuant to the preceding sentence shall increase the total Gross Profits otherwise calculated for purposes of Section 1 and 2 above.

  • 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.

  • During the Term, GSK shall devote Diligent Efforts to Commercialize (i) the Current Product for the Licensed Indication [ * ] and (ii) the Current Pediatric Product for the Licensed Indication [ * ] pursuant to GSK's development efforts to develop the Current Pediatric Product therefor in accordance with (and beginning at the time set forth in) Section 3.3(a).


More Definitions of Pediatric Product

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
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, 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 has the meaning set forth in Section 2.24(b).
Sample 1
Pediatric Product means the vitamin-related pharmaceutical product marketed and sold under the unregistered trademark "MVI-Pediatric".
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 any pharmaceutical product containing a Licensed Compound (alone or with other active ingredients), in all forms, presentations, formulations and dosage forms.

  • Collaboration Product means any pharmaceutical product in finished form that contains a Collaboration Compound, either as the sole active ingredient or in combination with one or more other active ingredients, and all present and future formulations, dosages and dosage forms thereof.

  • 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.

  • Generic Product means a product which (a) contains as its active pharmaceutical ingredient a compound that is (or is substantially the same as) the Licensed Compound, and (b) has been placed on the market pursuant to a validly granted marketing authorization.

  • 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.

  • 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 any and all activities undertaken at any time for a particular Licensed Product and that relate to the manufacturing, marketing, promoting, distributing, importing or exporting for sale, offering for sale, and selling of the Licensed Product, and interacting with Regulatory Authorities regarding the foregoing.

  • 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 pivotal Clinical Study, the results of which could be used to establish safety and efficacy of a Licensed Product in the Field as a basis for Regulatory Approval or that would otherwise satisfy requirements of 21 CFR 312.21(c), or its foreign equivalent.

  • Biologics License Application or “BLA” means, with respect to a country or extra-national territory, a request for permission to introduce, distribute, sell or market a biologic product in such country or some or all of such extra-national territory, including pursuant to 21 CFR 601.2 in the U.S.