Human Therapeutic Product definition

Human Therapeutic Product means any product for the treatment or management of any disease state in a human patient or any other human therapeutic indication derived from the Research Program in the course of research concerning a Target.
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Human Therapeutic Product means any product for prophylactic or
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Human Therapeutic Product means any Rx or OTC Drug Product for an indication within the Field or the Dermatology Indications. "Drug Product", as used herein, means a product that contains one or more therapeutically active compounds or that relates to a method of administering or using one or more. therapeutically active compounds. "Human Therapeutic Product" does not include Rx veterinary or OTC veterinary Drug Products.
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Examples of Human Therapeutic Product in a sentence

  • Wyeth shall keep for three (3) years from the date of each payment of royalties complete and accurate records of sales by Wyeth of each Licensed Human Therapeutic Product in sufficient detail to allow the accruing royalties to be determined accurately.

  • This requirement shall be deemed satisfied with respect to any specific Target area if Wyeth is developing any Human Therapeutic Product in that Target area.

  • OSI will cooperate with Wyeth at Wyeth's expense in the defense of any suit, action or proceeding against Wyeth or any sublicensee of Wyeth alleging the infringement of the intellectual property rights of a third party by reason of the use of Patent Rights or Technology in the manufacture, use or sale of any Licensed Human Therapeutic Product.

  • If the manufacture, use or sale by Wyeth of a Licensed Human Therapeutic Product would, in the opinion of both Wyeth and OSI, infringe a patent owned by a third party, Wyeth and OSI shall attempt to obtain a license under such patent.

  • Wyeth shall pay OSI a royalty based on the Net Sales of each Licensed Human Therapeutic Product, the manufacture, use or sale of which would infringe a Valid Claim within OSI Patent Rights or Wyeth Patent Rights if such manufacture, use or sale were by an unlicensed third party or which employs OSI Technology or Wyeth Technology.

  • Such royalty shall be paid from the date of first commercial sale of each such Licensed Human Therapeutic Product until the expiration of the last applicable patent to expire or ten (10) years from the date of such first commercial sale, whichever is later.

  • Such development will be shown by semi-annual progress reports which demonstrate that the Human Therapeutic Product remains an active candidate for the filing of a foreign equivalent of an Investigational New Drug Application.

  • Such royalty shall be paid in each country of the Territory from the date of first commercial sale of each such Licensed Human Therapeutic Product in each such country until the expiration of the last applicable patent to expire with respect to each such country or ten (10) years from the date of such first commercial sale in each such country, whichever is later.

  • Such payments shall be accompanied by a statement showing the Net Sales of each Licensed Human Therapeutic Product by Wyeth or any sublicensee of Wyeth in each country of the Territory and a calculation of the amount of royalty due.

  • The Licensed Human Therapeutic Product subject to royalty payment shall be deemed sold when invoiced, or if not invoiced, when the same shall be shipped or delivered to the third party.


More Definitions of Human Therapeutic Product

Human Therapeutic Product means a Product for the treatment or prevention of any disease, disorder or condition in humans (including, without limitation, any such Product comprising human or animal cells for transplantation into a human to replace or repair damaged tissue).
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Human Therapeutic Product means any product which is invented, discovered or developed utilizing a [*] including, without limitation, any of the [*] .
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Human Therapeutic Product means any product for prophylactic or ------------------------- therapeutic use in the prevention, treatment, cure or mitigation of any clinical indications in humans which consists of, comprises, is comprised of or is derived from:
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Human Therapeutic Product means any product for prophylactic or ------------------------- therapeutic use in the prevention or treatment of any clinical indications in humans, whether or not for the treatment or prevention of asthma, obesity, depression, (including unipolar major depressive disorder, and bipolar disorder), dementia, or osteoporosis, which is, or comprises: The remainder of Section 1.16 remains unchanged.
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Related to Human Therapeutic Product

  • Therapeutic Product means a health product categorised as a therapeutic product in the First Schedule to the Act;

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

  • cosmetic product means any substance or mixture intended to be placed in contact with the external parts of the human body (epi­ dermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours;

  • Therapeutic school means a residential group living facility:

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

  • Licensed Product means a product or part of a product in the Licensed Field of Use: (A) the making, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent; or (B) which is made with, uses or incorporates any Technology.

  • 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;

  • 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.

  • 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.

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

  • Licensed Compound means [***].

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

  • 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.

  • Therapeutic equivalent means that a Covered Drug can be expected to produce essentially the same therapeutic outcome and toxicity.

  • 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”).

  • Therapeutically equivalent drug products means drug products that contain the same active ingredients and are identical in strength or concentration, dosage form, and route of administration and that are classified as being therapeutically equivalent by the U.S. Food and Drug Administration pursuant to the definition of "therapeutically equivalent drug products" set forth in the most recent edition of the Approved Drug Products with Therapeutic Equivalence Evaluations, otherwise known as the "Orange Book."

  • 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.

  • 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.

  • 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.

  • FDA means the United States Food and Drug Administration and any successor agency thereto.

  • U.S. Territory means American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, the Commonwealth of Puerto Rico, or the U.S. Virgin Islands.

  • Clinical Trial means any human clinical trial of a Product.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Phase III Clinical Trial means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.

  • Biosimilar Product means, with respect to a Licensed Product and on a country-by-country basis, a product that [***].

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