Product Clinical Data definition

Product Clinical Data means all pre-clinical and clinical data, databases and intellectual property relating to the Product and the Licensed Patent Rights, including without limitation, raw case report files, final study reports, toxicology reports, regulatory information including all investigational new drug applications and such other information and data as may have been generated during or in connection with any pre-clinical and phase I clinical studies or other studies conducted on the Product or with respect to any Licensed Patent Rights.
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Product Clinical Data means all technical, scientific, chemical, biological, pharmacological and toxicological data (including all such data in support of the Product Registrations such as Phase III-B Clinical Trial data and Phase IV Clinical Trial data) generated in connection with the Product and any other data derived from past clinical studies related to the Product in the Territory, in each case which is owned by, or in the possession of or otherwise available to, Seller or its Affiliates (including all such data assigned or otherwise transferred to Seller pursuant to the Galderma Purchase Agreement).
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Examples of Product Clinical Data in a sentence

  • The Parties shall jointly own all Combination Therapy Clinical Data in equal and undivided shares, except for any Affimed Product Clinical Data comprised therein which shall be solely owned by Affimed, and any Artiva Product Clinical Data comprised therein which shall be solely owned by Xxxxxx.

Related to Product Clinical Data

  • Clinical Data means the information concerning the safety or performance that is generated from the use of a device and that are sourced from the following:

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

  • 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.

  • Licensed Compounds means: (a) Research Program Active Compounds; (b) Novartis Active Compounds; (c) salts, hydrates, solvates, esters, metabolites, intermediates, stereoisomers and polymorphs of Research Program Active Compounds or Novartis Active Compounds; and (d) prodrugs of Research Program Active Compounds or Novartis Active Compounds (any of the foregoing, a “Licensed Compound”).

  • Tobacco product manufacturer means an entity that after the date of enactment of this Act directly (and not exclusively through any affiliate):

  • 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;

  • Manufacturing Know-How means all information, techniques, inventions, discoveries, improvements, practices, methods, knowledge, skill, experience and other technology, whether or not patentable or copyrightable, and any copyrights based thereon, relating to or necessary or useful for the production, purification, packaging, storage and transportation of Collaboration Products, including without limitation specifications, acceptance criteria, manufacturing batch records, standard operating procedures, engineering plans, installation, operation and process qualification protocols for equipment, validation records, master files submitted to the FDA, process validation reports, environmental monitoring processes, test data including pharmacological, toxicological and clinical test data, cost data and employee training materials.

  • 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.

  • Manufacturing Technology means any and all patents, patent applications, know-how, and all intellectual property rights associated therewith that are owned or controlled by Licensor, and including all tangible embodiments thereof, that are necessary or useful for the manufacture of adeno-associated viruses, adeno-associated virus vectors, research or commercial reagents related thereto, Licensed Products, or other products, including manufacturing processes, technical information relating to the methods of manufacture, protocols, standard operating procedures, batch records, assays, formulations, quality control data, specifications, scale up, any and all improvements, modifications, and changes thereto, and any and all activities associated with such manufacture. Any and all chemistry, manufacturing, and controls (CMC), drug master files (DMFs), or similar materials provided to regulatory authorities and the information contained therein are deemed Manufacturing Technology.

  • Licensed Compound means [***].

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

  • 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.

  • Manufacturing Materials means parts, tools, dies, jigs, fixtures, plans, drawings, and information produced or acquired, or rights acquired, specifically to fulfill obligations set forth herein.

  • Product Candidate means any pharmaceutical product developed, manufactured and/or tested by or on behalf of the Company that has not received a Regulatory Authorization for commercial distribution other than in connection with pre-clinical or clinical trials.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Finished Product means a cannabis product in its final form to be sold at a retail premises.

  • Aerosol Product means a pressurized spray system that dispenses product ingredients by means of a propellant contained in a product or a product's container, or by means of a mechanically induced force. “Aerosol Product” does not include “Pump Spray.”

  • Approved clinical trial means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or Condition and is described in any of the following:

  • API means the American Petroleum Institute.

  • 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”).

  • Product Manufacturer means the entity that assembles the component parts to manufacture the final Product;

  • Participating Clinical Laboratory means a Clinical Laboratory which has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • Covered Products means Your Applications, Libraries, Passes, Safari Extensions, Safari Push Notifications, and/or FPS implementations developed under this Agreement.

  • Licensed Products means tangible materials which, in the course of manufacture, use, sale, or importation, would be within the scope of one or more claims of the Licensed Patent Rights that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.

  • 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.

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.