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 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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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.

  • 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.

  • Wyeth shall pay OSI a royalty based on the Net Sales in each country 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 of Wyeth Technology.

  • 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.

  • OSI shall provide to Wyeth or any sublicensee of Wyeth, at Wyeth's request and expense, any assistance reasonably necessary to enable Wyeth or such sublicensee to manufacture, use or sell each Licensed Human Therapeutic Product and to enjoy fully all the rights granted to Wyeth pursuant to this Agreement.

  • Wyeth shall pay OSI a royalty of *** percent *** of Net Sales of each Human Therapeutic Product licensed under Section 2.1 or 2.2. Only one royalty will be due on Net Sales of any such Human Therapeutic Product.

  • 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.


More Definitions of Human Therapeutic Product

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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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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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 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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Related to Human Therapeutic Product

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

  • 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, 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.

  • 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 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.

  • 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.”

  • 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” means the active pharmaceutical substance of the Drug in bulk form prior to incorporation into the Product.

  • Therapeutically equivalent drug products means drug products that contain the same active

  • 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 a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, or any post-approval human clinical trial, as applicable.

  • 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, the principal purpose of which is to demonstrate clinically and statistically the efficacy and safety of a Licensed Product for one or more indications in order to obtain Marketing Approval of such Licensed Product for such indication(s), as further defined in 21 C.F.R. §312.21 or a similar clinical study in a country other than the United States.

  • Biosimilar Product means, with respect to a Licensed Product in any country, any biosimilar product sold by a Third Party not authorized by or on behalf of Celgene, its Affiliates or Sublicensees, (a) that is a biosimilar biological product, as defined in 21 USC 379j-51 (or any successor or replacement thereof), a similar biological medicinal product, as defined in Annex I to Directive 2001/83/EC (or any successor or replacement thereof), or any similar biosimilar or generic product under the Laws of any country or jurisdiction, or (b) regarding which Regulatory Approval is obtained by referencing Regulatory Data of such Licensed Product.

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

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