Medical Device Product definition

Medical Device Product shall have the meaning ascribed to such term in Section 3.1(hh).
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Medical Device Product shall have the meaning ascribed to such term in Section 3.1(jj). “Pre-Notice” shall have the meaning ascribed to such term in Section 4.11(b). “Pro Rata Portion” shall have the meaning ascribed to such term in Section 4.11(e).
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Medical Device Product means a Product for which Ocera has obtained Regulatory Approval as a medical device (as opposed to as a pharmaceutical drug).
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Examples of Medical Device Product in a sentence

  • The Parties expressly acknowledge and agree that as of the Effective Date, Virpax intends to develop a Drug Product and does not intend to develop a Medical Device Product.

  • Nanomerics expressly acknowledges and agrees that the decision to change regulatory pathways is solely within Virpax’s discretion and, notwithstanding anything to the contrary hereunder, Virpax is under no obligation to develop a Medical Device Product.

  • Except for de minimis direct sales of PROW FUSION in 2012, the Company has never sold a Medical Device Product and has never had a customer for any Medical Device Product.

  • Kureha and Ocera confirm that Ocera shall, and shall require its Sublicensees to, collect information of adverse events believed to be related to any Medical Device Product for the IBS Indication in any country in the Licensed Territory in the manner equivalent to that in which Ocera carries out collection and report to Kureha of pharmacovigilance data regarding the Products as pharmaceutical drug in accordance with the Safety Agreement.

  • Either party may terminate this Agreement at the end of a 90-day period following Synergetics’ receipt of written notice from CODMAN if a judgment from a court of competent jurisdiction in the United States holds that the manufacture, use, importation or sale of a Medical Device Product, which has not been discontinued or otherwise removed from Schedule A, infringes the patent rights of a third party.

  • GENOVA VICE PRESIDENT OF RESEARCH AND DEVELOPMENTBiomedical Engineering Executive Brings Over 25 Years of Innovative Medical Device Product Development Experience Published 32 Peer-Reviewed Papers and Holds 30 U.S. Patents TORONTO, ON - February 6, 2017 - Titan Medical Inc.

  • In case that Ocera or any of its Sublicensees obtains Regulatory Approval as medical device for the IBS Indication in European Countries, Kureha shall not assume any obligations to supply Compound without charge as samples of such Medical Device Product for the IBS Indication in such European Countries under Section 4.1(c) of the Commercial Supply Agreement.

  • The Company has not been informed by the FDA that the FDA will prohibit the marketing, sale or use in the United States of any Medical Device Product being developed by the Company.

Related to Medical Device Product

  • medical device means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

  • 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;

  • 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.

  • 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.

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

  • 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.

  • 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.

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether

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

  • 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:

  • 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.

  • Investigational Medicinal Product means the study drug or control material as defined in the Protocol.

  • Radiopharmaceutical means any drug that exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons and includes any non-radioactive reagent kit or radionuclide generator that is intended to be used in the preparation of any such substance, but does not include drugs such as carbon-containing compounds or potassium-containing salts that include trace quantities of naturally occurring radionuclides. The term also includes any biological product that is labeled with a radionuclide or intended solely to be labeled with a radionuclide.

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

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